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CONTENTS

1 Introduction to Nursing Research and Evidence-Based Practice, 1

2 Introduction to Quantitative Research, 31

3 Introduction to Qualitative Research, 66

4 Examining Ethics in Nursing Research, 93

5 Research Problems, Purposes, and Hypotheses, 129

6 Understanding and Critically Appraising the Literature Review, 162

7 Understanding Theory and Research Frameworks, 189

8 Clarifying Quantitative Research Designs, 210

9 Examining Populations and Samples in Research, 248

10 Clarifying Measurement and Data Collection in Quantitative Research, 281

11 Understanding Statistics in Research, 317

12 Critical Appraisal of Quantitative and Qualitative Research for Nursing Practice, 361

13 Building an Evidence-Based Nursing Practice, 414

14 Outcomes Research, 466

Glossary, 500

Index, 515

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6th Edition

Understanding Nursing Research Building an Evidence-Based Practice

Susan K. Grove, PhD, RN, ANP-BC, GNP-BC Professor Emerita College of Nursing The University of Texas at Arlington Arlington, Texas; Adult Nurse Practitioner Family Practice Grand Prairie, Texas

Jennifer R. Gray, PhD, RN, FAAN George W. and Hazel M. Jay Professor, College of Nursing Associate Dean, College of Nursing The University of Texas at Arlington Arlington, Texas

Nancy Burns, PhD, RN, FCN, FAAN Professor Emerita College of Nursing The University of Texas at Arlington Arlington, Texas; Faith Community Nurse St. Matthew Cumberland Presbyterian Church Burleson, Texas

3251 Riverport Lane

St. Louis, Missouri 63043

UNDERSTANDING NURSING RESEARCH: BUILDING

AN EVIDENCE-BASED PRACTICE, EDITION SIX ISBN: 978-1-4557-7060-1

Copyright © 2015, 2011, 2007, 2003, 1999, 1995 by Saunders, an imprint of Elsevier Inc.

All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means,

electronic or mechanical, including photocopying, recording, or any information storage and retrieval system,

without permission in writing from the publisher. Details on how to seek permission, further information about the

Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance

Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions.

This book and the individual contributions contained in it are protected under copyright by the Publisher

(other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our

understanding, changes in research methods, professional practices, or medical treatment may become

necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating

and using any information, methods, compounds, or experiments described herein. In using such

information or methods they should be mindful of their own safety and the safety of others, including

parties for whom they have a professional responsibility.

With respect to any drug or pharmaceutical products identified, readers are advised to check the

most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be

administered, to verify the recommended dose or formula, the method and duration of administration, and

contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge

of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and

to take all appropriate safety precautions.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any

liability for any injury and/or damage to persons or property as a matter of products liability, negligence

or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in

the material herein.

International Standard Book Number: 978-1-4557-7060-1

Executive Content Strategist: Lee Henderson

Content Development Manager: Billie Sharp

Content Development Specialist: Charlene Ketchum

Publishing Services Manager: Deborah L. Vogel

Project Manager: Bridget Healy

Design Direction: Maggie Reid

Printed in China

Last digit is the print number: 9 8 7 6 5 4 3 2 1

CONTRIBUTOR AND REVIEWERS

CONTRIBUTOR

Diane Doran, RN, PhD, FCAHS

Professor Emerita

Lawrence S. Bloomberg Faculty of Nursing

University of Toronto

Toronto, Ontario

Revised Chapter 14

REVIEWERS

Lisa D. Brodersen, EdD, MA, RN

Professor, Coordinator of Institutional Research

and Effectiveness

Allen College

Waterloo, Iowa

Sara L. Clutter, PhD, RN

Associate Professor of Nursing

Waynesburg University

Waynesburg, Pennsylvania

Jacalyn P. Dougherty, PhD, RN

Nursing Research Consultant

JP Dougherty LLC

Aurora, Colorado

Joanne T. Ehrmin, RN, COA-CNS, PhD,

MSN, BSN

Professor

University of Toledo, College of Nursing

Toledo, Ohio

Betsy Frank, PhD, RN, ANEF

Professor Emerita

Indiana State University College of Nursing

Health, and Human Services

Terre Haute, Indiana

Tamara Kear, PhD, RN, CNS, CNN

Assistant Professor of Nursing

Villanova University

Villanova, Pennsylvania

Sharon Kitchie, PhD, RN

Adjunct Instructor

Keuka College

Keuka Park, New York

Madelaine Lawrence, PhD, RN

Associate Professor

University of North Carolina at Wilmington

Wilmington, North Carolina

Robin Moyers, PhD, RN-BC

Nurse Educator

Carl Vinson VA Medical Center

Dublin, Georgia

Sue E. Odom, DSN, RN

Professor of Nursing

Clayton State University

Morrow, Georgia

Teresa M. O’Neill, PhD, APRN, RNC

Professor

Our Lady of Holy Cross College

New Orleans, Louisiana

Sandra L. Siedlecki, PhD, RN, CNS

Senior Nurse Scientist

Cleveland Clinic

Cleveland, Ohio

Sharon Souter, PhD, RN, CNE

Dean and Professor

University of Mary Hardin Baylor

Belton, Texas

v

Molly J. Walker, PhD, RN, CNS, CNE

Professor

Angelo State University

San Angelo, Texas

Cynthia Ward, DNP, RN-BC, CMSRN,

ACNS-BC

Surgical Clinical Nurse Specialist

Carilion Roanoke Memorial Hospital

Roanoke, Virginia

Angela Wood, PhD, RN, Certified High-Risk

Prenatal Nurse

Associate Professor and Chair

Department of Nursing

Carson-Newman University

Jefferson City, Tennessee

Fatma A. Youssef, RN, DNSc, MPH

Professor Emerita

Marymount University

School of Health Professions

Arlington, Virginia

vi CONTRIBUTOR AND REVIEWERS

To all nurses who change the lives of patients through applying the best research evidence. —Susan, Jennifer, and Nancy

To my husband Jay Suggs who has provided me endless love and support during my development of research textbooks over the last 30 years.

—Susan

To my husband Randy Gray who is my love and my cheerleader. —Jennifer

To my husband Jerry who has supported all of my academic endeavors through 58 years of marriage.

—Nancy

PREFACE

Research is a major force in nursing, and the evidence generated from research is constantly chang-

ing practice, education, and health policy. Our aim in developing this essentials research text,

Understanding Nursing Research: Building an Evidence-Based Practice, is to create an excitement

about research in undergraduate students. The text emphasizes the importance of

baccalaureate-educated nurses being able to read, critically appraise, and synthesize research so

this evidence can be used to make changes in practice. A major goal of professional nursing

and health care is the delivery of evidence-based care. By making nursing research an integral part

of baccalaureate education, we hope to facilitate the movement of research into the mainstream of

nursing. We also hope this text increases student awareness of the knowledge that has been gen-

erated through nursing research and that this knowledge is relevant to their practice. Only through

research can nursing truly be recognized as a profession with documented effective outcomes for

the patient, family, nurse provider, and healthcare system. Because of this expanded focus on

evidence-based practice (EBP), we have subtitled this edition Building an Evidence-Based Practice.

Developing a sixth edition of Understanding Nursing Research has provided us with an oppor-

tunity to clarify and refine the essential content for an undergraduate research text. The text is

designed to assist undergraduate students in overcoming the barriers they frequently encounter

in understanding the language used in nursing research. The revisions in this edition are based

on our own experiences with the text and input from dedicated reviewers, inquisitive students,

and supportive faculty from across the country who provided us with many helpful suggestions.

Chapter 1, Introduction to Nursing Research and Evidence-Based Practice, introduces the

reader to nursing research, the history of research, and the significance of research evidence for

nursing practice. This chapter has been revised to include the most relevant types of research syn-

thesis being conducted in nursing—systematic review, meta-analysis, meta-synthesis, and mixed-

methods systematic review. The discussion of research methodologies and their importance in

generating an evidence-based practice for nursing has been updated and expanded to include

the exploratory-descriptive qualitative research method. A discussion of the Quality and Safety

Education for Nursing (QSEN) competencies and their link to research has been included in this

edition. Selected QSEN competencies are linked to the findings from studies presented as examples

throughout the text to increase students’ understanding of the importance in delivering quality,

safe health care to patients and families.

Chapter 2, Introduction to Quantitative Research, presents the steps of the quantitative research

process in a concise, clear manner and introduces students to the focus and findings of quantitative

studies. Extensive, recent examples of descriptive, correlational, quasi-experimental, and experi-

mental studies are provided, which reflect the quality of current nursing research.

Chapter 3, Introduction to Qualitative Research, describes five approaches to qualitative

research and the philosophies upon which they are based. These approaches include phenomenol-

ogy, grounded theory, ethnography, exploratory-descriptive qualitative, and historical research.

Data collection and analysis methods specific to qualitative research are discussed. Guidelines

for reading and critically appraising qualitative studies are explained using examples of published

studies.

viii

Chapter 4, Examining Ethics in Nursing Research, provides an extensive discussion of the use of

ethics in research and the regulations that govern the research process. Detailed content and cur-

rent websites are provided to promote students’ understanding of the Health Insurance Portability

and Accountability Act (HIPAA), the U.S. Department of Health and Human Services Protection

of Human Subjects, and the Federal Drug Administration regulations. Guidelines are provided to

assist students in critically appraising the ethical discussions in published studies and to participate

in the ethical review of research in clinical agencies.

Chapter 5, Research Problems, Purposes, and Hypotheses, clarifies the difference between

a problem and a purpose. Example problem and purpose statements are included from current

qualitative, quantitative, and outcome studies. Detailed guidelines are provided with examples

to direct students in critically appraising the problems, purposes, hypotheses, and variables in

studies.

Chapter 6, Understanding and Critically Appraising the Literature Review, begins with a

description of the content and quality of different types of publications that might be included

in a review. Guidelines for critically appraising published literature reviews are explored with a

focus on the differences in the purpose and timing of the literature review in quantitative and qual-

itative studies. The steps for finding appropriate sources, reading publications, and synthesizing

information into a logical, cohesive review are presented.

Chapter 7, Understanding Theory and Research Frameworks, briefly describes grand, middle

range, physiological, and scientific theories as the bases for study frameworks. The purpose of a

research framework is discussed with the acknowledgement that the framework may be implicit.

Guidelines for critically appraising the study framework are presented as well. The guidelines are

applied to studies with frameworks derived from research findings and from different types of

theories.

Chapter 8, Clarifying Quantitative Research Designs, addresses descriptive, correlational, quasi-

experimental, and experimental designs and criteria for critically appraising these designs in stud-

ies. The major strengths and threats to design validity are summarized in a table and discussed

related to current studies. This chapter has been expanded to include an introduction to random-

ized controlled trials (RCT) and mixed-methods approaches being conducted by nurses.

Chapter 9, Examining Populations and Samples in Research, provides a detailed discussion of

the concepts of sampling in research. Different types of sampling methods for both qualitative and

quantitative research are described. Guidelines are included for critically appraising the sampling

criteria, sampling method, and sample size of quantitative and qualitative studies.

Chapter 10, Clarifying Measurement and Data Collection in Quantitative Research, has been

updated to reflect current knowledge about measurement methods used in nursing research. Con-

tent has been expanded and uniquely organized to assist students in critically appraising the reli-

ability and validity of scales; precision and accuracy of physiologic measures; and the sensitivity,

specificity, and likelihood ratios of diagnostic and screening tests.

Chapter 11, Understanding Statistics in Research, focuses on the theories and concepts of the

statistical analysis process and the statistics used to describe variables, examine relationships, pre-

dict outcomes, and examine group differences in studies. Guidelines are provided for critically

appraising the results and discussion sections of nursing studies. The results from selected studies

are critically appraised and presented as examples throughout this chapter.

Chapter 12, Critical Appraisal of Quantitative and Qualitative Research for Nursing Practice,

summarizes and builds on the critical appraisal content provided in previous chapters and offers

direction for conducting critical appraisals of quantitative and qualitative studies. The guidelines

for critically appraising qualitative studies have been significantly revised and simplified. This

ixPREFACE

chapter also includes a current qualitative and quantitative study, and these two studies are crit-

ically appraised using the guidelines provided in this chapter.

Chapter 13, Building an Evidence-Based Nursing Practice, has been significantly updated to

reflect the current trends in health care to provide evidence-based nursing practice. Detailed guide-

lines are provided for critically appraising the four common types of research synthesis conducted

in nursing (systematic review, meta-analysis, meta-synthesis, and mixed-method systematic

review). These guidelines were used to critically appraise current research syntheses to assist stu-

dents in examining the quality of published research syntheses and the potential use of research

evidence in practice. The chapter includes theories to assist nurses and agencies in moving toward

EBP. Translational research is introduced as a method for promoting the use of research evidence in

practice.

Chapter 14, Introduction to Outcomes Research, was significantly revised by Dr. Diane Doran,

one of the leading authorities in the conduct of outcomes research. The goal of this chapter is to

increase students’ understanding of the impact of outcomes research on nursing and health care.

Content and guidelines are provided to assist students in reading and critically appraising the out-

comes studies appearing in the nursing literature.

The sixth edition is written and organized to facilitate ease in reading, understanding, and crit-

ically appraising studies. The major strengths of the text are as follows:

• State-of-the art coverage of EBP—a topic of vital importance in nursing.

• Balanced coverage of qualitative and quantitative research methodologies.

• Rich and frequent illustration of major points and concepts from the most current nursing

research literature from a variety of clinical practice areas.

• Study findings implications for practice and link to QSEN competencies were provided.

• A clear, concise writing style that is consistent among the chapters to facilitate student

learning.

• Electronic references and websites that direct the student to an extensive array of informa-

tion that is important in reading, critically appraising, and using research knowledge in

practice.

This sixth edition of Understanding Nursing Research is appropriate for use in a variety of under-

graduate research courses for both RN and general students because it provides an introduction to

quantitative, qualitative, and outcomes research methodologies. This text not only will assist stu-

dents in reading research literature, critically appraising published studies, and summarizing

research evidence to make changes in practice, but it also can serve as a valuable resource for prac-

ticing nurses in critically appraising studies and implementing research evidence in their clinical

settings.

LEARNING RESOURCES TO ACCOMPANY UNDERSTANDING NURSING RESEARCH, 6TH EDITION

The teaching/learning resources to accompany Understanding Nursing Research have been

expanded for both the instructor and student to allow a maximum level of flexibility in course

design and student review.

Evolve Instructor Resources A comprehensive suite of Instructor Resources is available online at http://evolve.elsevier.com/

Grove/understanding/ and consists of a Test Bank, PowerPoint slides, an Image Collection, Answer

x PREFACE

Guidelines for the Appraisal Exercises provided for students, and new TEACH for Nurses Lesson

Plans, which replace and enhance the Instructor’s Manual provided for previous editions.

Test Bank The Test Bank consists of approximately 550 NCLEX

® Examination–style questions, including

approximately 10% of questions in alternate item formats. Each question is coded with the correct

answer, a rationale from the textbook, a page cross-reference, and the cognitive level in the new

Bloom’s Taxonomy (with the cognitive level from the original Bloom’s Taxonomy in parentheses).

The Test Bank is provided in ExamView and Evolve LMS formats.

PowerPoint Slides

The PowerPoint slide collection contains approximately 800 slides, now including seamlessly inte-

grated Audience Response System Questions, images, and new Unfolding Case Studies. The

PowerPoints have been simplified and converted into bulleted-list format (using less narrative).

Content details in the slides have been moved as appropriate into the Notes area of the slides.

New Unfolding Case Studies focus on practical EBP/PICO questions, such as a nurse on a unit

needing to perform a literature search or to identify a systematic review or meta-analysis. Power-

Point presentations are fully customizable.

Image Collection

The electronic Image Collection consists of all images from the text. This collection can be used in

classroom or online presentations to reinforce student learning.

NEW TEACH for Nurses Lesson Plans

TEACH for Nurses is a robust, customizable, ready-to-use collection of chapter-by-chapter Lesson

Plans that provide everything you need to create an engaging and effective course. Each chapter

includes the following:

• Objectives

• Teaching Focus

• Key Terms

• Nursing Curriculum Standards

○ QSEN/NLN Competencies ○ Concepts ○ BSN Essentials

• Student Chapter Resources

• Instructor Chapter Resources

• Teaching Strategies

• In-Class/Online Case Study

Evolve Student Resources The Evolve Student Resources include interactive Review Questions, a Research Article Library

consisting of 10 full-text research articles, Critical Appraisal Exercises based on the articles in

the Research Article Library, and new Printable Key Points.

• The interactive Review Questions (approximately 25 per chapter) aid the student in reviewing

and focusing on the chapter material.

xiPREFACE

• The Research Article Library is an updated collection of 10 research articles, taken from leading

nursing journals.

• The Critical Appraisal Exercises are a collection of application exercises, based on the articles in

the Research Article Library, that help students learn to appraise and apply research findings.

Answer Guidelines are provided for the instructor.

• New Printable Key Points provide students with a convenient review tool.

Study Guide The companion Study Guide, written by the authors of the main text, provides both time-tested

and innovative exercises for each chapter in Understanding Nursing Research, 6th Edition. Included

for each chapter are a brief Introduction, a Key Terms exercise, Key Ideas exercises, Making Con-

nections exercises, Exercises in Critical Analysis, and Going Beyond exercises. An integral part of

the Study Guide is an appendix of three published research studies, which are referenced through-

out. These three recently published nursing studies (two quantitative studies and one qualitative

study) can be used in classroom or online discussions, as well as to address the Study Guide ques-

tions. The Study Guide provides exercises that target comprehension of concepts used in each

chapter. Exercises — including fill-in-the-blank, matching, and multiple-choice questions —

encourage students to validate their understanding of the chapter content. Critical Appraisal Activ-

ities provide students with opportunities to apply their new research knowledge to evaluate the

quantitative and qualitative studies provided in the back of the Study Guide.

New to this edition are the following features: an increased emphasis on evidence-based prac-

tice; new Web-Based Activities, an increased emphasis on high-value learning activities, reorga-

nized back-matter for quick reference, and quick-reference printed tabs.

• Increased emphasis on evidence-based practice: This edition of the Study Guide features an

expanded focus on evidence-based practice (EBP) to match that of the revised textbook. This

focus helps students who are new to nursing research see the value of understanding the

research process and applying it to evidence-based nursing practice.

• Web-Based Activities: Each chapter now includes a Web-Based Activity section, to teach stu-

dents to use the Internet appropriately for scholarly research and EBP.

• Increased high-value learning activities: The use of crossword puzzles has been reduced to allow

room for the addition of learning activities with greater learning value.

• Back matter reorganized for quick reference: The “Answers to Study Guide Exercises” has been

retitled “Answer Key” and not numbered as an appendix. Each of the three published studies are

now separate appendix (three appendices total), rather than a single appendix. This simplifies

cross referencing in the body of the Study Guide.

• Quick-reference printed tabs: Quick-reference printed tabs have been added to differentiate the

Answer Key and each of the book’s three published studies (four tabs total), for improved nav-

igation and usability.

xii PREFACE

ACKNOWLEDGMENTS

Developing this essentials research text was a 2-year project, and there are many people we would

like to thank. We want to extend a very special thank you to Dr. Diane Doran for her revision of

Chapter 14 focused on outcomes research. We are very fortunate that she was willing to share her

expertise and time so that students might have the most current information about outcomes

research.

We want to express our appreciation to the Dean and faculty of The University of Texas at

Arlington College of Nursing for their support and encouragement. We also would like to thank

other nursing faculty members across the world who are using our book to teach research and have

spent valuable time to send us ideas and to identify errors in the text. Special thanks to the students

who have read our book and provided honest feedback on its clarity and usefulness to them. We

would also like to recognize the excellent reviews of the colleagues, listed on the previous pages,

who helped us make important revisions in the text.

In conclusion, we would like to thank the people at Elsevier who helped produce this book. We

thank the following individuals who have devoted extensive time to the development of this sixth

edition, the instructor’s ancillary materials, student study guide, and all of the web-based compo-

nents. These individuals include: Lee Henderson, Billie Sharp, Charlene Ketchum, Bridget Healy,

Jayashree Balasubramaniam, and Vallavan Udayaraj.

Susan K. Grove

PhD, RN, ANP-BC, GNP-BC

Jennifer R. Gray

PhD, RN, FAAN

Nancy Burns

PhD, RN, FCN, FAAN

xiii

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C H A P T E R

1 Introduction to Nursing Research and

Evidence-Based Practice

C H A P T E R OV E R V I E W

What Is Nursing Research? 3

What Is Evidence-Based Practice? 3

Purposes of Research for Implementing an

Evidence-Based Nursing Practice, 6

Description, 6

Explanation, 7

Prediction, 7

Control, 8

Historical Development of Research in

Nursing, 9

Florence Nightingale, 11

Nursing Research: 1900s through the 1970s, 11

Nursing Research: 1980s and 1990s, 12

Nursing Research: in the Twenty-First

Century, 14

Acquiring Knowledge in Nursing, 15

Traditions, 16

Authority, 16

Borrowing, 16

Trial and Error, 17

Personal Experience, 17

Role Modeling, 17

Intuition, 18

Reasoning, 18

Acquiring Knowledge through Nursing

Research, 19

Introduction to Quantitative and Qualitative

Research, 19

Introduction to Outcomes Research, 21

Understanding Best Research Evidence for

Practice, 21

Strategies Used to Synthesize Research

Evidence, 22

Levels of Research Evidence, 24

Introduction to Evidence-Based Guidelines, 25

What Is Your Role in Nursing Research? 25

Key Concepts, 27

References, 28

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Define research, nursing research, and

evidence-based practice.

2. Describe the purposes of research in

implementing an evidence-based practice for

nursing.

3. Describe the past and present activities

influencing research in nursing.

4. Discuss the link of Quality and Safety Education

for Nurses (QSEN) to research.

5. Apply the ways of acquiring nursing knowledge

(tradition, authority, borrowing, trial and error,

personal experience, role modeling, intuition,

reasoning, and research) to the interventions

implemented in your practice.

6. Identify the common types of research—

quantitative, qualitative, or outcomes—

conducted to generate essential evidence for

nursing practice.

1

7. Describe the following strategies for

synthesizing healthcare research: systematic

review, meta-analysis, meta-synthesis, and

mixed-methods systematic review.

8. Identify the levels of research evidence available

to nurses for practice.

9. Describe the use of evidence-based guidelines in

implementing evidence-based practice.

10. Identify your role in research as a

professional nurse.

K E Y T E R M S

Authority, p. 16

Best research evidence, p. 3

Borrowing, p. 16

Case study, p. 11

Clinical expertise, p. 4

Control, p. 8

Critical appraisal of research,

p. 27

Deductive reasoning, p. 18

Description, p. 6

Evidence-based guidelines,

p. 25

Evidence-based practice

(EBP), p. 3

Explanation, p. 7

Gold standard, p. 25

Inductive reasoning, p. 18

Intuition, p. 18

Knowledge, p. 15

Mentorship, p. 18

Meta-analysis, p. 22

Meta-synthesis, p. 23

Mixed-methods systematic

review, p. 23

Nursing research, p. 3

Outcomes research, p. 21

Personal experience, p. 17

Prediction, p. 7

Premise, p. 18

Qualitative research, p. 20

Qualitative research

synthesis, p. 23

Quality and Safety

Education for Nurses

(QSEN), p. 15

Quantitative research, p. 19

Reasoning, p. 18

Research, p. 3

Role modeling, p. 17

Systematic review, p. 22

Traditions, p. 16

Trial and error, p. 17

Welcome to the world of nursing research. You may think it strange to consider research a world,

but it is a truly new way of experiencing reality. Entering a new world means learning a unique

language, incorporating new rules, and using new experiences to learn how to interact effectively

within that world. As you become a part of this new world, you will modify and expand your per-

ceptions and methods of reasoning. For example, using research to guide your practice involves

questioning, and you will be encouraged to ask such questions as these:

• What is the patient’s healthcare problem?

• What nursing intervention would effectively manage this problem in your practice?

• Is this nursing intervention based on sound research evidence?

• Would another intervention be more effective in improving your patient’s outcomes?

• How can you use research most effectively in promoting an evidence-based practice (EBP)?

Because research is a new world to many of you, we have developed this text to facilitate your entry

into and understanding of this world and its contribution to the delivery of quality, safe nursing care.

This first chapter clarifies the meaning of nursing research and its significance in developing an

evidence-based practice (EBP) for nursing. This chapter also explores the research accomplishments

in the profession over the last 160 years. The ways of acquiring knowledge in nursing are discussed,

and the common research methodologies used for generating research evidence for practice (quan-

titative, qualitative, and outcomes research) are introduced. The critical elements of evidence-based

nursing practice are introduced, including strategies for synthesizing research evidence, levels of

research evidence or knowledge, and evidence-based guidelines. Nurses’ roles in research are

described based on their level of education and their contributions to the implementation of EBP.

2 CHAPTER 1 Introduction to Nursing Research

WHAT IS NURSING RESEARCH?

The word research means “to search again” or “to examine carefully.” More specifically, research is

a diligent, systematic inquiry, or study that validates and refines existing knowledge and develops

new knowledge. Diligent, systematic study indicates planning, organization, and persistence. The

ultimate goal of research is the development of an empirical body of knowledge for a discipline or

profession, such as nursing.

Defining nursing research requires determining the relevant knowledge needed by nurses.

Because nursing is a practice profession, research is essential to develop and refine knowledge that

nurses can use to improve clinical practice and promote quality outcomes (Brown, 2014; Doran,

2011). Expert researchers have studied many interventions, and clinicians have synthesized these

studies to provide guidelines and protocols for use in practice. Practicing nurses and nursing stu-

dents, like you, need to be able to read research reports and syntheses of research findings to imple-

ment evidence-based interventions in practice and promote positive outcomes for patients and

families. For example, extensive research has been conducted to determine the most effective tech-

nique for administering medications through an intramuscular (IM) injection. This research was

synthesized and used to develop evidence-based guidelines for administering IM injections

(Cocoman & Murray, 2008; Nicoll & Hesby, 2002).

Nursing research is also needed to generate knowledge about nursing education, nursing

administration, healthcare services, characteristics of nurses, and nursing roles. The findings from

these studies influence nursing practice indirectly and add to nursing’s body of knowledge.

Research is needed to provide high-quality learning experiences for nursing students. Through

research, nurses can develop and refine the best methods for delivering distance nursing education

and for using simulation to improve student learning. Nursing administration and health services

studies are needed to improve the quality, safety, and cost-effectiveness of the healthcare delivery

system. Studies of nurses and nursing roles can influence nurses’ quality of care, productivity, job

satisfaction, and retention. In this era of a nursing shortage, additional research is needed to deter-

mine effective ways to recruit individuals and retain them in the profession of nursing. This type of

research could have a major impact on the quality and number of nurses providing care to patients

and families in the future.

In summary, nursing research is a scientific process that validates and refines existing knowl-

edge and generates new knowledge that directly and indirectly influences nursing practice. Nursing

research is the key to building an EBP for nursing (Brown, 2014).

WHAT IS EVIDENCE-BASED PRACTICE?

The ultimate goal of nursing is an evidence-based practice that promotes quality, safe, and cost-

effective outcomes for patients, families, healthcare providers, and the healthcare system (Brown,

2014; Craig & Smyth, 2012; Melnyk & Fineout-Overholt, 2011). Evidence-based practice (EBP)

evolves from the integration of the best research evidence with clinical expertise and patients’ needs

and values (Institute of Medicine [IOM], 2001; Sackett, Straus, Richardson, Rosenberg, & Haynes,

2000). Figure 1-1 identifies the elements of EBP and demonstrates the major contribution of the

best research evidence to the delivery of this practice. The best research evidence is the empirical

knowledge generated from the synthesis of quality study findings to address a practice problem.

Later, this chapter discusses the strategies used to synthesize research, levels of best research evi-

dence, and sources for this evidence. A team of expert researchers, healthcare professionals, and

sometimes policy makers and consumers will synthesize the best research evidence to develop

3CHAPTER 1 Introduction to Nursing Research

standardized guidelines for clinical practice. For example, a team of experts conducted, critically

appraised, and synthesized research related to the chronic health problem of hypertension (HTN)

to develop an EBP guideline. Research evidence from this guideline is presented as an example later

in this section.

Clinical expertise is the knowledge and skills of the healthcare professional who is providing

care. The clinical expertise of a nurse depends on his or her years of clinical experience, current

knowledge of the research and clinical literature, and educational preparation. The stronger the

nurse’s clinical expertise, the better is his or her clinical judgment in using the best research evi-

dence in practice (Brown, 2014; Craig & Smyth, 2012). EBP also incorporates the needs and values

of the patient (see Figure 1-1). The patient’s need(s) might focus on health promotion, illness pre-

vention, acute or chronic illness management, rehabilitation, and/or a peaceful death. In addition,

patients bring values or unique preferences, expectations, concerns, and cultural beliefs to the clin-

ical encounter. With EBP, patients and their families are encouraged to take an active role in the

management of their health. It is the unique combination of the best research evidence being

applied by expert nurse clinicians in providing quality, safe, and cost-effective care to a patient

and family with specific health needs and values that results in EBP.

Extensive research is needed to develop sound empirical knowledge for synthesis into the best

research evidence needed for practice. Findings from a single study are not enough evidence for

determining the effectiveness of an intervention in practice. Research evidence from multiple stud-

ies are synthesized to develop guidelines, standards, protocols, algorithms (clinical decision trees),

or policies to direct the implementation of a variety of nursing interventions. As noted earlier, a

national guideline has been developed for the management of hypertension, The Seventh Report of

the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood

Pressure (JNC 7). The complete JNC 7 guideline for the management of high blood pressure is

available online at www.nhlbi.nih.gov/guidelines/hypertension (National Heart, Lung, and

Blood Institute [NHLBI], 2003). In January of 2014, the American Society of Hypertension

(ASH) and the International Society of Hypertension (ISH) published new clinical practice guide-

lines for the management of hypertension in the community (Weber et al, 2014). The JNC 7 guide-

line and the ASH and ISH clinical practice guideline identified the same classification system for

blood pressure (Table 1-1). These guidelines include the classification of blood pressure as normal,

prehypertension, hypertension stage 1, and hypertension stage 2. Both guidelines also recommend

Best Research Evidence

Clinical Expertise

Patient Needs & Values

Evidence- Based

Practice

FIG 1-1 Model of Evidence-Based Practice (EBP).

4 CHAPTER 1 Introduction to Nursing Research

life style modifications (balanced diet, exercise program, normal weight, and nonsmoker) and car-

diovascular disease (CVD) risk factors (hypertension, obesity, dyslipidemia, diabetes mellitus, cig-

arette smoking, physical inactivity, microalbuminuria, and family history of premature CVD)

education. You need to use an evidence-based guideline in monitoring your patients’ blood pres-

sure (BP) and educating them about lifestyle modifications to improve their BP and reduce their

CVD risk factors (NHLBI, 2003; Weber et al., 2014).

The Eighth Joint National Committee (JNC 8) published “2014 Evidence-Based Guideline for

the Management of High Blood Pressure in Adults” in December of 2013 (James et al. 2013). How-

ever, these guidelines currently lack the recognition of any national organization. Additional work

is needed to ensure that the guidelines are approved by the NHLBI, ASH, the American Heart

Association (AHA), and/or the American College of Cardiology (ACC). For this textbook, the

evidence-based guidelines for management of hypertension presented in Table 1-1 are recom-

mended for students and nurses to use in caring for their patients (Weber et al., 2014).

Figure 1-2 provides an example of the delivery of evidence-based nursing care to African Amer-

ican women with high BP. In this example, the best research evidence is classification of BP and

education on lifestyle modification (LSM) and CVD risk factors based on the ASH (Weber et al.,

2014) and JNC 7 (NHLBI, 2003) guidelines for management of high BP (see Table 1-1). These

guidelines, developed from the best research evidence related to BP, LSM, and CVD risks moni-

toring and education, is translated by registered nurses and nursing students to meet the needs and

values of African American women with high BP. The quality outcome of EBP in this example is

women with a BP less than 140/90 mm Hg or referral for medication treatment (see Figure 1-2). A

detailed discussion of how to locate, critically appraise, and use national standardized guidelines in

practice is found in Chapter 13.

TABLE 1-1 CLASSIFICATION OF BLOOD PRESSURE WITH NURSING INTERVENTIONS FOR EVIDENCE-BASED PRACTICE (EBP)

CLASSIFICATION OF BLOOD PRESSURE (BP) NURSING INTERVENTIONS{

BP CATEGORY

SYSTOLIC BP

(mm Hg)*

DIASTOLIC BP

(mm Hg)*

LIFESTYLE

MODIFICATION{

CARDIOVASCULAR DISEASE

(CVD) RISK FACTORS

EDUCATION}

Normal <120 and <80 Encourage Yes

Prehypertension 120-139 or 80-89 Yes Yes

Stage 1

hypertension

140-159 or 90-99 Yes Yes

Stage 2

hypertension

<160 or <100 Yes Yes

*Treatment is determined by the highest BP category, systolic or diastolic. {Treat patients with chronic kidney disease or diabetes to BP goal of <130/80 mm Hg. { Lifestyle modification—balanced diet, exercise program, normal weight, and nonsmoker.

}CVD risk factors—hypertension; obesity (body mass index � 30 kg/m2), dyslipidemia, diabetes mellitus, cigarette smoking, physical inactivity, microalbuminuria, estimated glomerular filtration rate<60 mL/min, age (>55 years for men, >65 years

for women), and family history of premature CVD (men<55 years, women<65 years).

Adapted from National Heart, Lung, and Blood Institute. (2003). The seventh report of the Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7). Retrieved June 18, 2013 from, www.nhlbi.

nih.gov/guidelines/hypertension/; and Weber, M. A., Schiffrin, E. L., White, W. B., Mann, S., Lindholm, L. H., Kenerson, J. G.,

et al. (2014). Clinical practice guidelines for the management of hypertension in the community: A statement by the American

Society of Hypertension and the International Society of Hypertension. Journal of Hypertension, 32(1), 4-5.

5CHAPTER 1 Introduction to Nursing Research

PURPOSES OF RESEARCH FOR IMPLEMENTING AN EVIDENCE-BASED NURSING PRACTICE

Through nursing research, empirical knowledge can be developed to improve nursing care, patient

outcomes, and the healthcare delivery system. For example, nurses need a solid research base to

implement and document the effectiveness of selected nursing interventions in treating particular

patient problems and promoting positive patient and family outcomes. Also, nurses need to use

research findings to determine the best way to deliver healthcare services to ensure that the greatest

number of people receive quality, safe care. Accomplishing these goals will require you to locate

EBP guidelines or to appraise critically, synthesize, and apply research evidence that provides a

description, explanation, prediction, and control of phenomena in your clinical practice.

Description Description involves identifying and understanding the nature of nursing phenomena and, some-

times, the relationships among them (Chinn & Kramer, 2011). Through research, nurses are able to

(1) describe what exists in nursing practice; (2) discover new information; (3) promote under-

standing of situations; and (4) classify information for use in the discipline. Some examples of

clinically important research evidence that have been developed from research focused on descrip-

tion include:

• Identification of the incidence and spread of infection in healthcare agencies

• Identification of the cluster of symptoms for a particular disease

• Description of the responses of individuals to a variety of health conditions and aging

• Description of the health promotion and illness prevention strategies used by a variety of

populations

• Determination of the incidence of a disease locally (e.g., incidence of West Nile virus in Texas),

nationally, and internationally (e.g., spread of bird flu).

Rush, Watts, and Janke (2013, p. 10) have conducted a qualitative study to describe “rural and

urban older adults’ perspectives of strength in their daily lives.” (The types of research conducted in

nursing—quantitative, qualitative, and outcomes—are discussed later in this chapter.) They noted

the following in this study:

Hypertension Guidelines: BP classification, LSM, and CVD risks (Best research evidence)

Registered Nurse (RN): Monitor & educate (Clinical expert)

Female, African American with high BP (Patient needs and values)

Normal BP: £ 140/90, Knowledge of LSM & CVD Risks or Referral for Medication Treatment (Evidence-Based Practice)

FIG 1-2 Evidence-based practice for African American women with high blood pressure (BP).

6 CHAPTER 1 Introduction to Nursing Research

The findings from this study provided nurses with descriptions of older adults’ perspectives of

strength and the strategies that they use to stay strong. You can use the findings from this study to

encourage physical, mental, and social activities to assist older adults in staying strong. This type of

research, focused on description, is essential groundwork for studies to provide explanations, pre-

dictions, and control of nursing phenomena in practice.

Explanation Explanation clarifies the relationships among phenomena and identifies possible reasons why cer-

tain events occur. Research focused on explanation provides the following types of evidence essen-

tial for practice:

• Determination of assessment data (subjective data from the health history and objective data

from the physical examination) that need to be gathered to address a patient’s health need

• The link of assessment data to a diagnosis

• The link of causative risk factors or causes to illness, morbidity, and mortality

• Determination of the relationships among health risks, health behaviors, and health status

• Determination of links among demographic characteristics, disease status, psychosocial factors,

and patients’ responses to treatment.

For example, Manojlovich, Sidani, Covell, and Antonakos (2011) conducted an outcomes study

to examine the links or relationships between a “nurse dose” (nurse characteristics and staffing)

and adverse patient outcomes. The nurse characteristics examined were education, experience, and

skill mix. The staffing variables included full-time employees, registered nurse (RN)-to-patient

ratio, and RN hours per patient day. The adverse outcomes examined were methicillin-resistant

Staphylococcus aureus (MRSA) infections and reported patient falls for a sample of inpatient adults

in acute care units. The researchers found that the nurse characteristics and staffing variables were

significantly correlated with MRSA infections and reported patient falls. Therefore the nursing

characteristics and staffing were potential predictors of the incidence of MRSA infections and

patient falls. This study illustrates how explanatory research can identify relationships among

nursing phenomena that can be the basis for future research focused on prediction and control.

Prediction Through prediction, one can estimate the probability of a specific outcome in a given situation

(Chinn & Kramer, 2011). However, predicting an outcome does not necessarily enable one to mod-

ify or control the outcome. It is through prediction that the risk of illness or injury is identified and

linked to possible screening methods to identify and prevent health problems. Knowledge gener-

ated from research focused on prediction is critical for EBP and includes the following:

• Prediction of the risk for a disease or injury in different populations

• Prediction of behaviors that promote health and prevent illness

• Prediction of the health care required based on a patient’s need and values

“Nurses’ strength enhancement efforts should raise older adults’ awareness that strength is not an

unlimited resource but needs to be constantly replenished. . . . Older adult participants described

changes in strength that ranged from fluctuating daily changes to insidious, gradual declines and

to drastic and unexpected losses. . . . Older adults’ strategies for staying strong were consistent with

their more holistic views of strength but may not be approaches nurses typically take into account.

Although nurses need to give continued emphasis to promoting physical activity, they must also give

equal attention to encouraging mental and social activities because of the important role they play for

older adults staying strong.” Rush et al., 2013, p. 15

7CHAPTER 1 Introduction to Nursing Research

Lee, Faucett, Gillen, Krause, and Landry (2013) conducted a quantitative study to examine the

factors that were perceived by critical care nurses (CCNs) to predict the risk of musculoskeletal

(MSK) injury from work. They found that greater physical workload, greater job strain, more fre-

quent patient-handling tasks, and lack of a lifting team or devices were predictive of the CCNs’

perceptions of risk of MSK injury. They recommended that “occupational health professionals,

nurse managers, and nursing organizations should make concerted efforts to ensure the safety

of nurses by providing effective preventive measures. Improving the physical and psychosocial

work environment may make nursing jobs safer, reduce the risk of MSK injury, and improve

nurses’ perceptions of job safety” (Lee et al., 2013, p. 43). This predictive study isolated indepen-

dent variables (physical workload, job strain, patient-handling tasks, and lack of lifting devices or

teams) that were predictive of MSK injuries in CCNs. The variables identified in predictive studies

require additional research to ensure that their manipulation or control results in quality outcomes

for patients, healthcare professionals, and healthcare agencies (Creswell, 2014; Doran, 2011;

Kerlinger & Lee, 2000).

Control If one can predict the outcome of a situation, the next step is to control or manipulate the situation

to produce the desired outcome. In health care, control is the ability to write a prescription to

produce the desired results. Using the best research evidence, nurses could prescribe specific inter-

ventions to meet the needs of patients and their families (Brown, 2014; Craig & Smyth, 2012). The

results of multiple studies in the following areas have enabled nurses to deliver care that increases

the control over the outcomes desired for practice:

• Testing interventions to improve the health status of individuals, families, and communities

• Testing interventions to improve healthcare delivery

• Synthesis of research for development into EBP guidelines

• Testing the effectiveness of EBP guideline in clinical agencies

Extensive research has been conducted in the area of safe administration of IM injections. This

research has been critically appraised, synthesized, and developed into evidence-based guidelines

to direct the administration of medications by an IM route to infants, children, and adults in a

variety of practice settings (Cocoman & Murray, 2008; Nicoll & Hesby, 2002). The EBP guideline

for IM injections is based on the best research evidence and identifies the appropriate needle size

and length to use for administering different types of medications, the safest injection site (ven-

trogluteal) for many medications, and the best injection technique to deliver a medication, min-

imize patient discomfort, and prevent physical damage (Cocoman & Murray, 2008; Greenway,

2004; Nicoll & Hesby, 2002; Rodger & King, 2000). Using the evidence-based knowledge for

administering IM injections helps control the achievement of the following outcomes in practice:

(1) adequate administration of medication to promote patient health; (2) minimal patient dis-

comfort; and (3) no physical damage to the patient.

Broadly, the nursing profession is accountable to society for providing quality, safe, and cost-

effective care for patients and families. Therefore the care provided by nurses must be constantly

evaluated and improved on the basis of new and refined research knowledge. Studies that document

the effectiveness of specific nursing interventions make it possible to implement evidence-based

care that will produce the best outcomes for patients and their families. The quality of research

conducted in nursing affects not only the quality of care delivered, but also the power of nurses

in making decisions about the healthcare delivery system. The extensive number of clinical studies

conducted in the last 50 years has greatly expanded the scientific knowledge available to you for

describing, explaining, predicting, and controlling phenomena within your nursing practice.

8 CHAPTER 1 Introduction to Nursing Research

HISTORICAL DEVELOPMENT OF RESEARCH IN NURSING

The development of research in nursing has changed drastically over the last 160 years and holds

great promise for the twenty-first century. Initially, nursing research evolved slowly, from the

investigations of Nightingale in the nineteenth century to the studies of nursing education in

the 1930s and 1940s and the research of nurses and nursing roles in the 1950s and 1960s. From

the 1970s through the 2010s, an increasing number of nursing studies that focused on clinical

problems have produced findings that directly affected practice. Clinical research continues to

be a major focus today, with the goal of developing an EBP for nursing. Reviewing the history

of nursing research enables you to identify the accomplishments and understand the need for fur-

ther research to determine the best research evidence for use in practice. Table 1-2 outlines the key

historical events that have influenced the development of research in nursing.

TABLE 1-2 HISTORICAL EVENTS INFLUENCING THE DEVELOPMENT OF RESEARCH IN NURSING

YEAR EVENT

1850 Florence Nightingale is recognized as the first nurse researcher.

1900 American Journal of Nursing is published.

1923 Teachers College at Columbia University offers the first educational doctoral program for nurses.

1929 First Master’s in Nursing Degree is offered at Yale University.

1932 Association of Collegiate Schools of Nursing is organized to promote conduct of research.

1950 American Nurses Association (ANA) publishes study of nursing functions and activities.

1952 First research journal in nursing, Nursing Research, is published.

1953 Institute of Research and Service in Nursing Education is established.

1955 American Nurses Foundation is established to fund nursing research.

1957 Southern Regional Educational Board (SREB), Western Interstate Commission on Higher

Education (WICHE), Midwestern Nursing Research Society (MNRS), and New England Board of

Higher Education (NEBHE) are established to support and disseminate nursing research.

1963 International Journal of Nursing Studies is published.

1965 ANA sponsors the first nursing research conferences.

1967 Sigma Theta Tau International Honor Society of Nursing publishes Image, emphasizing nursing

scholarship; now Journal of Nursing Scholarship.

1970 ANA Commission on Nursing Research is established.

1972 Cochrane published Effectiveness and Efficiency, introducing concepts relevant to evidence-

based practice (EBP).

ANA Council of Nurse Researchers is established.

1973 First Nursing Diagnosis Conference is held, which evolved into North American Nursing Diagnosis

Association (NANDA).

1976 Stetler/Marram Model for Application of Research Findings to Practice is published.

1978 Research in Nursing & Health and Advances in Nursing Science are published.

1979 Western Journal of Nursing Research is published.

1980s-

1990s

Sackett and colleagues developed methodologies to determine “best evidence” for practice.

1982-1983 Conduct and Utilization of Research in Nursing (CURN) Project is published.

1983 Annual Review of Nursing Research is published.

Continued

9CHAPTER 1 Introduction to Nursing Research

TABLE 1-2 HISTORICAL EVENTS INFLUENCING THE DEVELOPMENT OF RESEARCH IN NURSING—cont’d

YEAR EVENT

1985 National Center for Nursing Research (NCNR) is established to support and fund nursing

research.

1987 Scholarly Inquiry for Nursing Practice is published.

1988 Applied Nursing Research and Nursing Science Quarterly are published.

1989 Agency for Healthcare Policy and Research (AHCPR) is established and publishes EBP guidelines.

1990 Nursing Diagnosis, official journal of NANDA, is published; now International Journal of Nursing

Terminologies and Classifications.

ANA established the American Nurses Credentialing Center (ANCC), which implemented the

Magnet Hospital Designation Program for Excellence in Nursing Services.

1992 Healthy People 2000 is published by U.S. Department of Health and Human Services (U.S. DHHS).

Clinical Nursing Research is published.

1993 NCNR is renamed the National Institute of Nursing Research (NINR) to expand funding for nursing

research.

Journal of Nursing Measurement is published.

Cochrane Collaboration is initiated, providing systematic reviews and EBP guidelines

(http://www.cochrane.org).

1994 Qualitative Health Research is published.

1999 AHCPR is renamed Agency for Healthcare Research and Quality (AHRQ).

2000 Healthy People 2010 is published by U.S. DHHS.

Biological Research for Nursing is published.

2001 Stetler publishes her model Steps of Research Utilization to Facilitate Evidence-Based

Practice.

Institute of Medicine (IOM) report Crossing the Quality Chasm: A New Health System for the 21st

Century published, focusing on key healthcare issues of quality and safety.

2002 The Joint Commission revises accreditation policies for hospitals supporting evidence-based

health care.

NANDA becomes international—NANDA-I.

2003 IOM report Health Professions Education: A Bridge to Quality published, identifying six

competencies essential for education of nurses and other health professionals.

2004 Worldviews on Evidence-Based Nursing is published.

2005 Quality and Safety Education for Nurses (QSEN) initiative for development of competencies for

prelicensure and graduate education is developed.

2006 American Association of Colleges of Nursing (AACN) position statement on nursing research is

published.

2007 QSEN website (http://qsen.org) is launched, featuring teaching strategies and resources to

facilitate the attainment of the QSEN competencies.

2010 IOM report The Future of Nursing: Leading Change recommends that 80% of the nursing

workforce be prepared at the baccalaureate level by the year 2020.

2011 NINR current strategic plan published.

American Nurses Association (ANA) current research agenda is developed.

2013 Current QSEN competencies for prelicensure nurses available online at http://qsen.org/

competencies/pre-licensure-ksas.

2013 Healthy People 2020 available at U.S. DHHS website,

http://www.healthypeople.gov/2020/topicsobjectives2020/default.aspx.

AHRQ current mission and funding priorities available online (http://www.ahrq.gov/).

NINR current mission and funding opportunities available online (http://www.ninr.nih.gov/).

10 CHAPTER 1 Introduction to Nursing Research

Florence Nightingale Nightingale (1859) is recognized as the first nurse researcher, with her initial studies focused on the

importance of a healthy environment in promoting patients’ physical and mental well-being. She

studied aspects of the environment, such as ventilation, cleanliness, purity of water, and diet, to

determine the influence on patients’ health, which continue to be important areas of study today

(Herbert, 1981). Nightingale is also noted for her data collection and statistical analyses, especially

during the Crimean War. She gathered data on soldier morbidity and mortality rates and the factors

influencing them and presented her results in tables and pie charts, a sophisticated type of data pre-

sentation for the period (Palmer, 1977). Nightingale was the first woman elected to the Royal Statistical

Society (Oakley, 2010) and her research was highlighted in Scientific American (Cohen, 1984).

Nightingale’s research enabled her to instigate attitudinal, organizational, and social changes.

She changed the attitudes of the military and society about the care of the sick. The military began

to view the sick as having the right to adequate food, suitable quarters, and appropriate medical

treatment, which greatly reduced the mortality rate (Cook, 1913). Nightingale improved the orga-

nization of army administration, hospital management, and hospital construction. Because of

Nightingale’s research evidence and influence, society began to accept responsibility for testing

public water, improving sanitation, preventing starvation, and decreasing morbidity and mortality

rates (Palmer, 1977).

Nursing Research: 1900s through the 1970s The American Journal of Nursing was first published in 1900 and, late in the 1920s and 1930s, case

studies began appearing in this journal. A case study involves an in-depth analysis and systematic

description of one patient or group of similar patients to promote understanding of healthcare

interventions. Case studies are one example of the practice-related research that has been con-

ducted in nursing over the last century.

Nursing educational opportunities expanded, with Teachers College at Columbia University

offering the first educational doctoral program for nurses in 1923 and Yale University offering

the first master’s degree in nursing in 1929. In 1950 the American Nurses Association (ANA) ini-

tiated a 5-year study on nursing functions and activities. In 1959 the findings from this study were

used to develop statements on functions, standards, and qualifications for professional nurses.

During that time, clinical research began expanding as nursing specialty groups, such as commu-

nity health, psychiatric-mental health, medical-surgical, pediatrics, and obstetrics, developed stan-

dards of care. The research conducted by the ANA and specialty groups provided the basis for the

nursing practice standards that currently guide professional practice (Gortner & Nahm, 1977).

In the 1950s and 1960s nursing schools began introducing research and the steps of the research

process at the baccalaureate level, and Master of Science in Nursing (MSN) level nurses were pro-

vided a background for conducting small replication studies. In 1953 the Institute for Research and

Service in Nursing Education was established at Teachers College of Columbia University and

began providing research experiences for doctoral students (Gortner & Nahm, 1977). The increase

in research activities prompted the publication of the first research journal, Nursing Research, in

1952. The American Nurses Foundation was established in 1955 to fund nursing research projects.

The Southern Regional Educational Board (SREB), Western Interstate Commission on Higher

Education (WICHE), Midwestern Nursing Research Society (MNRS), and New England Board

of Higher Education (NEBHE) were formed in 1957 to support and disseminate nursing research

across the United States.

In the 1960s an increasing number of clinical studies focused on quality care and the develop-

ment of criteria to measure patient outcomes. Intensive care units were developed, which

11CHAPTER 1 Introduction to Nursing Research

promoted the investigation of nursing interventions, staffing patterns, and cost-effectiveness of

care (Gortner & Nahm, 1977). An additional research journal, the International Journal of Nursing

Studies, was published in 1963. In 1965 the ANA sponsored the first of a series of nursing research

conferences to promote the communication of research findings and the use of these findings in

clinical practice.

In the late 1960s and 1970s nurses were involved in the development of models, conceptual

frameworks, and theories to guide nursing practice. The nursing theorists’ work provided direc-

tion for future nursing research. In 1978, Chinn became the editor of a new journal, Advances in

Nursing Science, which included nursing theorists’ work and related research. Another event

influencing research was the establishment of the ANA Commission on Nursing Research in

1970. In 1972 the commission established the Council of Nurse Researchers to advance research

activities, provide an exchange of ideas, and recognize excellence in research. The commission also

influenced the development of federal guidelines for research with human subjects and sponsored

research programs nationally and internationally (See, 1977).

The communication of research findings was a major issue in the 1970s (Barnard, 1980). Sigma

Theta Tau International, the Honor Society for Nursing, sponsored national and international

research conferences, and chapters of this organization sponsored many local conferences to com-

municate research findings. Sigma Theta Tau first published Image, now entitled Journal of Nursing

Scholarship, in 1967; it includes research articles and summaries of research conducted on selected

topics. Stetler and Marram developed the first model in nursing to promote the application of

research findings to practice in 1976. Two additional research journals were first published in

the 1970s, Research in Nursing & Health in 1978 and the Western Journal of Nursing Research

in 1979.

Professor Archie Cochrane originated the concept of evidence-based practice with a book

he published in 1972, Effectiveness and Efficiency: Random Reflections on Health Services.

Cochrane advocated the provision of health care based on research to improve its quality. To facil-

itate the use of research evidence in practice, the Cochrane Center was established in 1992 and the

Cochrane Collaboration in 1993. The Cochrane Collaboration and Library house numerous

resources to promote EBP, such as systematic reviews of research and evidence-based guidelines

for practice (see later; also see the Cochrane Collaboration at http://www.cochrane.org).

In the 1970s the nursing process became the focus of many studies, with investigations of assess-

ment techniques, nursing diagnoses classification, goal-setting methods, and specific nursing

interventions. The first Nursing Diagnosis Conference, held in 1973, evolved into the North

American Nursing Diagnosis Association (NANDA). In 2002 NANDA became international, known

as NANDA-I. NANDA-I supports research activities focused on identifying appropriate diagnoses

for nursing and generating an effective diagnostic process. NANDA’s journal, Nursing Diagnosis,

was published in 1990 and was later renamed the International Journal of Nursing Terminologies

and Classifications. Details on NANDA-I can be found on their website (http://www.nanda.org).

Nursing Research: 1980s and 1990s The conduct of clinical research was the focus of the 1980s, and clinical journals began publishing

more studies. One new research journal was published in 1987, Scholarly Inquiry for Nursing Prac-

tice, and two in 1988, Applied Nursing Research and Nursing Science Quarterly. Although the body

of empirical knowledge generated through clinical research increased rapidly in the 1980s, little of

this knowledge was used in practice. During 1982 and 1983, the studies from a federally funded

project, Conduct and Utilization of Research in Nursing (CURN), were published to facilitate the

use of research to improve practice (Horsley, Crane, Crabtree, & Wood, 1983).

12 CHAPTER 1 Introduction to Nursing Research

In 1983 the first volume of the Annual Review of Nursing Research was published (Werley &

Fitzpatrick, 1983). These volumes include experts’ reviews of research organized into four

areas—nursing practice, nursing care delivery, nursing education, and the nursing profession.

These summaries of current research knowledge encourage the use of research findings

in practice and provide direction for future research. Publication of the Annual Review of

Nursing Research continues today, with leading expert nurse scientists providing summaries

of research in their areas of expertise. The increased research activities in nursing resulted

in the publication of Clinical Nursing Research in 1992 and the Journal of Nursing Measurement

in 1993.

Qualitative research was introduced in the late 1970s; the first studies appeared in nursing jour-

nals in the 1980s. The focus of qualitative research was holistic, with the intent to discover meaning

and gain new insight and understanding of issues relevant to nursing. The number of qualitative

researchers and studies expanded greatly in the 1990s, with qualitative studies appearing in most of

the nursing research and clinical journals. In 1994 a journal focused on disseminating qualitative

research, Qualitative Health Research, was first published.

Another priority of the 1980s was to obtain increased funding for nursing research. Most of the

federal funds in the 1980s were designated for medical studies involving the diagnosis and treat-

ment of diseases. However, the ANA achieved a major political victory for nursing research with

the creation of the National Center for Nursing Research (NCNR) in 1985. The purpose of this

center was to support the conduct and dissemination of knowledge developed through basic

and clinical nursing research, training, and other programs in patient care research

(Bauknecht, 1985). Under the direction of Dr. Ada Sue Hinshaw, the NCNR became the National

Institute of Nursing Research (NINR) in 1993 to increase the status of nursing research and obtain

more funding.

Outcomes research emerged as an important methodology for documenting the effectiveness of

healthcare services in the 1980s and 1990s. This effectiveness research evolved from the quality

assessment and quality assurance functions that originated with the professional standards review

organizations (PSROs) in 1972. In 1989 the Agency for Healthcare Policy and Research (AHCPR)

was established to facilitate the conduct of outcomes research (Rettig, 1991). AHCPR also had an

active role in communicating research findings to healthcare practitioners and was responsible for

publishing the first clinical practice guidelines. These guidelines included a synthesis of the best

research evidence, with directives for practice developed by healthcare experts in various areas.

Several of these evidence-based guidelines were published in the 1990s and provided standards

for practice in nursing and medicine. The Healthcare Research and Quality Act of 1999 reauthor-

ized the AHCPR, changing its name to the Agency for Healthcare Research and Quality (AHRQ).

This significant change positioned the AHRQ as a scientific partner with the public and private

sectors to improve the quality and safety of patient care.

Building on the process of research utilization, physicians, nurses, and other healthcare profes-

sionals focused on the development of EBP for health care during the 1990s. A research group led

by Dr. David Sackett at McMaster University in Canada developed explicit research methodologies

to determine the “best evidence” for practice. David Eddy first used the term evidence-based in

1990, with the focus on providing EBP for medicine (Craig & Smyth, 2012; Sackett et al.,

2000). The American Nurses Credentialing Center (ANCC) implemented the Magnet Hospital

Designation Program for Excellence in Nursing Services in 1990, which emphasized EBP for nurs-

ing. The emphasis on EBP in nursing resulted in more biological studies and randomized con-

trolled trials (RCTs) being conducted and led to the publication of Biological Research for

Nursing in 2000.

13CHAPTER 1 Introduction to Nursing Research

Nursing Research: in the Twenty-First Century The vision for nursing research in the twenty-first century includes conducting quality studies

using a variety of methodologies, synthesizing the study findings into the best research evidence,

and using this research evidence to guide practice (Brown, 2014; Craig & Smyth, 2012; Melnyk &

Fineout-Overholt, 2011). EBP has become a stronger focus in nursing and healthcare agencies over

the last 15 years. In 2002, The Joint Commission (formerly called the Joint Commission on

Accreditation of Healthcare Organizations), responsible for accrediting healthcare organizations,

revised the accreditation policies for hospitals to support the implementation of evidence-based

health care. To facilitate the movement of nursing toward EBP in clinical agencies, Stetler (2001)

developed her Research Utilization to Facilitate EBP Model (see Chapter 13 for a description of this

model). The focus on EBP in nursing was supported with the initiation of the Worldviews on

Evidence-Based Nursing journal in 2004.

The American Association of Colleges of Nursing (AACN), established in 1932 to promote the

quality of nursing education, revised their position statement on nursing research in 2006 to pro-

vide future directions for the discipline. To ensure an effective research enterprise in nursing, the

discipline must (1) create a research culture, (2) provide high-quality educational programs (bac-

calaureate, master’s, practice-focused doctorate, research-focused doctorate, and postdoctorate)

to prepare a workforce of nurse scientists, (3) develop a sound research infrastructure, and (4)

obtain sufficient funding for essential research (AACN, 2006). The complete AACN position state-

ment on nursing research can be found online at http://www.aacn.nche.edu/publications/

position/nursing-research. In 2011 the ANA published a research agenda compatible with the

AACN (2006) research position statement.

The focus of healthcare research and funding has expanded from the treatment of illness to

include health promotion and illness prevention. Healthy People 2000 and Healthy People 2010,

documents published by the U.S. Department of Health and Human Services (U.S. DHHS,

2000), have increased the visibility of health promotion goals and research. Healthy People 2020

information is now available at the U.S. DHHS (2013) website http://www.healthypeople.gov/

2020/. Some of the new topics covered by Healthy People 2020 include adolescent health, blood

disorders and blood safety, dementias (including Alzheimer’s Disease), early and middle child-

hood, genomics, global health, healthcare-associated infections, lesbian, gay, bisexual, and trans-

gender health, older adults, preparedness, sleep health, and social determinants of health. In the

next decade, nurse researchers will have a major role in the development of interventions to pro-

mote health and prevent illness in individuals, families, and communities.

The AHRQ is the lead agency supporting research designed to improve the quality of health

care, reduce its cost, improve patient safety, decrease medical errors, and broaden access to essen-

tial services. AHRQ (2013) conducts and sponsors research that provides evidence-based informa-

tion on healthcare outcomes, quality, cost, use, and access. This research information is needed to

promote effective healthcare decision making by patients, clinicians, health system executives, and

policy makers. The AHRQ (2013) website (http://www.ahrq.gov) provides the most current infor-

mation on this agency and includes current guidelines for clinical practice.

Current Actions of the National Institute of Nursing Research The mission of the National Institute of Nursing Research (NINR) is to “promote and improve

the health of individuals, families, communities, and populations. The Institute supports and

conducts clinical and basic research and research training on health and illness across the

lifespan to build the scientific foundation for clinical practice, prevent disease and disability,

manage and eliminate symptoms caused by illness, and improve palliative and end-of-life care”

14 CHAPTER 1 Introduction to Nursing Research

(NINR, 2013). The NINR is seeking expanded funding for nursing research and is encouraging a

variety of methodologies (quantitative, qualitative, and outcomes research) to be used to generate

essential knowledge for nursing practice. The NINR (2013) website (http://ninr.nih.gov) provides

the most current information on the institute’s research funding opportunities and supported

studies. The strategic plan for the NINR (2011) is available online at https://www.ninr.nih.gov/

sites/www.ninr.nih.gov/files/ninr-strategic-plan-2011.pdf.

Linking Quality and Safety Education for Nursing Competencies and Nursing Research In 2001 the Institute of Medicine (IOM) published a report, Crossing the Quality Chasm: A New

Health System for the 21st Century, that emphasized the importance of quality and safety in the

delivery of health care. In 2003 the IOM published a report, Health Professions Education:

A Bridge to Quality, which identified the six competency areas essential for inclusion in nursing

education to ensure that students were able to deliver quality, safe care. Specific competencies

were identified for the following six areas: patient-centered care, teamwork and collaboration,

evidence-based practice, quality improvement, safety, and informatics. The Quality and Safety

Education for Nurses (QSEN) initiative is focused on developing the requisite knowledge, skills,

and attitude (KSA) statements for each of the competencies for pre-licensure and graduate edu-

cation. The QSEN initiative has been funded since 2005 by the Robert Wood Johnson

Foundation.

The QSEN Institute website (http://qsen.org), launched in 2007, features teaching strategies

and resources to facilitate the accomplishments of the QSEN competencies in nursing

educational programs. The most current competencies for the prelicensure educational pro-

grams can be found online at http://qsen.org/competencies/pre-licenrue-ksas (QSEN, 2013;

Sherwood & Barnsteiner, 2012). The EBP competency is defined as “integrating the best current

evidence with clinical expertise and patient/family preferences and values for delivery of optimal

health care” (QSEN, 2013). Undergraduate nursing students need to be skilled in critical

appraisal of studies, use of appropriate research evidence in practice, adherence to institutional

review board (IRB) guidelines, and appropriate data collection. Diffusion of the QSEN compe-

tencies across nursing educational programs is a major focus for educators who are shaping

students’ learning experiences and outcomes based on these competencies (Barnsteiner,

Disch, Johnson, McGuinn, Chappell, & Swartwout, 2013). In this text, the QSEN competencies

are linked to relevant research content and the findings from selected studies. Your expanded

knowledge of research is an important part of your developing an EBP and is necessary to attain

the QSEN competencies.

ACQUIRING KNOWLEDGE IN NURSING

Acquiring knowledge in nursing is essential for the delivery of quality, safe patient and family

nursing care. Some key questions about knowledge include the following: What is knowledge?

How is knowledge acquired in nursing? Is most of nursing’s knowledge based on research?

Knowledge is essential information, acquired in a variety of ways, that is expected to be an accu-

rate reflection of reality and is incorporated and used to direct a person’s actions (Kaplan, 1964).

During your nursing education, you acquire an extensive amount of knowledge from your class-

room and clinical experiences. You learn to synthesize, incorporate, and apply this knowledge so

that you can practice as a nurse.

The quality of your nursing practice depends on the quality of the knowledge that you

acquire. Therefore you need to question the quality and credibility of new information that

15CHAPTER 1 Introduction to Nursing Research

you hear or read. For example, what are the sources of knowledge that you are acquiring during

your nursing education? Are the nursing interventions taught based more on research or tradi-

tion? Which interventions are based on research, and which need further study to determine

their effectiveness?

Nursing has historically acquired knowledge through traditions, authority, borrowing, trial and

error, personal experience, role modeling, intuition, and reasoning. However, in the last 20 years,

most nursing texts include content that is based on research evidence, and most faculty members

support their lectures and educational strategies with study findings. This section introduces dif-

ferent ways of acquiring knowledge in nursing.

Traditions Traditions include “truths” or beliefs based on customs and trends. Nursing traditions from the

past have been transferred to the present by written and oral communication and role modeling,

and they continue to influence the practice of nursing. For example, some of the policy and pro-

cedure manuals in hospitals contain traditional ideas. Traditions can positively influence nursing

practice because they were developed from effective past experiences. However, traditions also can

narrow and limit the knowledge sought for nursing practice. For example, nursing units are fre-

quently organized and run according to set rules or traditions that may not be efficient or effective.

Often these traditions are neither questioned nor changed because they have existed for years and

are frequently supported by those with power and authority. Nursing’s body of knowledge needs to

be more evidence-based than traditional if nurses are to have a powerful impact on patient

outcomes.

Authority An authority is a person with expertise and power who is able to influence opinion and behavior.

A person is given authority because it is thought that she or he knows more in a given area than

others. Knowledge acquired from an authority is illustrated when one person credits another as the

source of information. Nurses who publish articles and books or develop theories are frequently

considered authorities. Students usually view their instructors as authorities, and clinical nursing

experts are considered authorities within the clinical practice setting. It is important that nurses

with authority teach and practice based on research evidence versus being based on customs and

traditions.

Borrowing Some nursing leaders have described part of nursing’s knowledge as information borrowed from

disciplines such as medicine, sociology, psychology, physiology, and education (McMurrey, 1982).

Borrowing in nursing involves the appropriation and use of knowledge from other fields or dis-

ciplines to guide nursing practice. Nursing has borrowed in two ways. For years, some nurses have

taken information from other disciplines and applied it directly to nursing practice. This informa-

tion was not integrated within the unique focus of nursing. For example, some nurses have used

the medical model to guide their nursing practice, thus focusing on the diagnosis and treatment of

disease. This type of borrowing continues today as nurses use advances in technology to become

highly specialized and focused on the detection and treatment of disease. The second way of bor-

rowing, which is more useful in nursing, involves integrating information from other disciplines

within the focus of nursing. For example, nurses borrow knowledge from other disciplines such as

psychology and sociology, but integrate this knowledge in their holistic care of patients and fam-

ilies experiencing acute and chronic illnesses.

16 CHAPTER 1 Introduction to Nursing Research

Trial and Error Trial and error is an approach with unknown outcomes that is used in a situation of uncertainty

in which other sources of knowledge are unavailable. Because each patient responds uniquely to a

situation, there is uncertainty in nursing practice. Hence nurses must use trial and error in

providing nursing care. However, this trial and error approach frequently involves no formal

documentation of effective and ineffective nursing actions. With this strategy, knowledge is

gained from experience, but often it is not shared with others. The trial and error approach

to acquiring knowledge also can be time-consuming because you may implement multiple inter-

ventions before finding one that is effective. There also is a risk of implementing nursing actions

that are detrimental to a patient’s health. If studies are conducted on nursing interventions,

selection and implementation of interventions need to be based on scientific knowledge rather

than on trial and error.

Personal Experience Personal experience involves gaining knowledge by being personally involved in an event, situa-

tion, or circumstance. Personal experience enables the nurse to gain skills and expertise by pro-

viding care to patients and families in clinical settings. Learning that occurs from personal

experience enables the nurse to cluster ideas into a meaningful whole. For example, you may read

about giving an IM injection or be told how to give an injection in a classroom setting, but you do

not know how to give an injection until you observe other nurses giving injections to patients and

actually give several injections yourself.

The amount of personal experience affects the complexity of a nurse’s knowledge base. Benner

(1984) conducted a phenomenological qualitative study to identify the levels of experience in the

development of clinical knowledge and expertise, and these include (1) novice, (2) advanced

beginner, (3) competent, (4) proficient, and (5) expert. Novice nurses have no personal experience

in the work they are to perform, but have some preconceptions and expectations about clinical

practice that they acquired during their education. These preconceptions and expectations are

challenged, refined, confirmed, or refuted by personal experience in a clinical setting. The

advanced beginner nurse has just enough experience to recognize and intervene in recurrent sit-

uations. For example, the advanced beginner is able to recognize and intervene in managing

patients’ pain. Competent nurses are able to generate and achieve long-range goals and plans

because of years of personal experience. The competent nurse also can use her or his personal

knowledge to take conscious, deliberate actions that are efficient and organized. From a more com-

plex knowledge base, the proficient nurse views the patient as a whole and as a member of a family

and community. The proficient nurse recognizes that each patient and family responds differently

to illness and health. The expert nurse has an extensive background of experience and is able to

identify accurately and intervene skillfully in a situation. Personal experience increases the ability

of the expert nurse to grasp a situation intuitively, with accuracy and speed.

Benner’s qualitative research (1984) provided an increased understanding of how knowledge is

acquired through personal experience. As you gain clinical experience during your educational

program and after you graduate, you will note your movement through these different levels of

knowledge.

Role Modeling Role modeling is learning by imitating the behaviors of an expert. In nursing, role modeling

enables the novice nurse to learn through interactions with or examples set by highly competent,

expert nurses. Role models include admired teachers, expert clinicians, researchers, or those who

17CHAPTER 1 Introduction to Nursing Research

inspire others through their example. An intense form of role modeling is mentorship, in which

the expert nurse serves as a teacher, sponsor, guide, and counselor for the novice nurse. The

knowledge gained through personal experience is greatly enhanced by a quality relationship with

a role model or mentor. Many new graduates enter internship programs provided by clinical

agencies so that expert nurses can mentor them during the novice’s first few months of

employment.

Intuition Intuition is an insight into or understanding of a situation or event as a whole that usually cannot

be explained logically (Grove, Burns, & Gray, 2013). Because intuition is a type of knowing that

seems to come unbidden, it may also be described as a “gut feeling” or “hunch.” Because intuition

cannot easily be explained scientifically, many people are uncomfortable with it. Some even think

that it does not exist. However, intuition is not the lack of knowing; rather, it is a result of deep

knowledge (Benner, 1984). This knowledge is so deeply incorporated that it is difficult to bring it to

the surface consciously and express it in a logical manner. Some nurses can intuitively recognize

when a patient is experiencing a health crisis. Using this intuitive knowledge, these nurses can

assess the patient’s condition, intervene, and contact the physician as needed for medical

intervention.

Reasoning Reasoning is the processing and organizing of ideas to reach conclusions. Through reasoning, peo-

ple are able to make sense of their thoughts, experiences, and research evidence (Grove et al., 2013).

This type of logical thinking is often evident in the oral presentation of an argument, in which each

part is linked to reach a logical conclusion. The science of logic includes inductive and deductive

reasoning. Inductive reasoning moves from the specific to the general; particular instances are

observed and then combined into a larger whole or a general statement (Chinn & Kramer,

2011). An example of inductive reasoning follows.

PARTICULAR INSTANCES

A headache is an altered level of health that is stressful.

A terminal illness is an altered level of health that is stressful.

GENERAL STATEMENT

Therefore it can be induced that all altered levels of health are stressful.

Deductive reasoning moves from the general to the specific or from a general premise to a

particular situation or conclusion (Chinn & Kramer, 2011). A premise or proposition is a state-

ment of the proposed relationship between two or more concepts. An example of deductive

reasoning follows.

PREMISES

All humans experience loss.

All adolescents are humans.

CONCLUSION

Therefore it can be deduced that all adolescents experience loss.

In this example, deductive reasoning is used to move from the two general premises about

humans and adolescents to the conclusion that “All adolescents experience loss.” However, the con-

clusions generated from deductive reasoning are valid only if they are based on valid premises.

Research is a means to test and confirm or refute a premise or proposition so that valid premises

can be used as a basis for reasoning in nursing practice.

18 CHAPTER 1 Introduction to Nursing Research

ACQUIRING KNOWLEDGE THROUGH NURSING RESEARCH

Acquiring knowledge through traditions, authority, borrowing, trial and error, personal experi-

ence, role modeling, intuition, and reasoning is important in nursing. However, these ways of

acquiring knowledge are inadequate in providing an EBP (Brown, 2014; Craig & Smyth, 2012).

The knowledge needed for practice is specific and holistic, as well as process-oriented and

outcomes-focused. Thus a variety of research methods are needed to generate this knowledge. This

section introduces quantitative, qualitative, and outcomes research methods that are used to gen-

erate empirical knowledge for nursing practice. These research methods are essential to generate

evidence for the following specific goals of the nursing profession (AACN, 2006; ANA, 2011;

NINR, 2013):

• Promoting an understanding of patients’ and families’ experiences with health and illness

(a common focus of qualitative research)

• Implementing effective nursing interventions to promote patient health (a common focus of

quantitative research)

• Providing quality, safe, and cost-effective care within the healthcare system (a common focus of

outcomes research)

Introduction to Quantitative and Qualitative Research Quantitative and qualitative research methods complement each other because they generate dif-

ferent types of knowledge that are useful in nursing practice. Familiarity with these two types of

research will help you identify, understand, and critically appraise these studies. Quantitative and

qualitative research methodologies have some similarities; both require researcher expertise,

involve rigor in implementation of studies, and generate scientific knowledge for nursing practice.

Some of the differences between the two methodologies are presented in Table 1-3.

Most of the studies conducted in nursing have used quantitative research methods. Quantita-

tive research is a formal, objective, systematic process in which numerical data are used to obtain

information about the world. The quantitative approach toward scientific inquiry emerged from a

branch of philosophy called logical positivism, which operates on strict rules of logic, truth, laws,

and predictions. Quantitative researchers hold the position that “truth” is absolute and that a sin-

gle reality can be defined by careful measurement. To find truth, the researcher must be objective,

which means that values, feelings, and personal perceptions cannot enter into the measurement of

reality. Quantitative research is conducted to test theory by describing variables (descriptive

research), examining relationships among variables (correlational research), and determining

cause and effect interactions between variables (quasi-experimental and experimental research;

TABLE 1-3 CHARACTERISTICS OF QUANTITATIVE AND QUALITATIVE RESEARCH METHODS

CHARACTERISTIC QUANTITATIVE RESEARCH QUALITATIVE RESEARCH

Philosophical origin Logical positivism Naturalistic, interpretive, humanistic

Focus Concise, objective, reductionistic Broad, subjective, holistic

Reasoning Logistic, deductive Dialectic, inductive

Basis of knowing Cause and effect relationships Meaning, discovery, understanding

Theoretical focus Tests theory Develops theory and frameworks

Researcher involvement Control Shared interpretation

19CHAPTER 1 Introduction to Nursing Research

Grove et al., 2013; Shadish, Cook, & Campbell, 2002). Chapter 2 describes the different types of

quantitative research and the quantitative research process.

Qualitative research is a systematic, subjective approach used to describe life experiences and

situations and give them meaning (Munhall, 2012). This research methodology evolved from the

behavioral and social sciences as a method of understanding the unique, dynamic, holistic nature

of humans. The philosophical base of qualitative research is interpretive, humanistic, and natural-

istic and is concerned with understanding the meaning of social interactions by those involved

(Standing, 2009). Qualitative researchers believe that truth is complex and dynamic and can be

found only by studying people as they interact with and in their sociohistorical settings

(Creswell, 2014; Munhall, 2012). Nurses’ interest in conducting qualitative research began in

the late 1970s. Currently, an extensive number of qualitative studies are being conducted that

use various qualitative research methods. Qualitative research is conducted to promote an under-

standing of human experiences and situations and develop theories that describe these experiences

and situations. Because human emotions are difficult to quantify (i.e., assign a numerical value to),

qualitative research seems to be a more effective method of investigating emotional responses than

quantitative research (see Table 1-3). Chapter 3 describes the different types of qualitative research.

Types of Quantitative and Qualitative Research

Several types of quantitative and qualitative research have been conducted to generate nursing

knowledge for practice. These types of research can be classified in a variety of ways. The classi-

fication system for this book is presented in Box 1-1 and includes the most common types of quan-

titative and qualitative research conducted in nursing. The quantitative research methods are

classified into four categories—descriptive, correlational, quasi-experimental, and experimental

(Grove et al., 2013; Kerlinger & Lee, 2000; Shadish et al., 2002; see Chapter 2).

• Descriptive research explores new areas of research and describes situations as they exist in

the world.

• Correlational research examines relationships and is conducted to develop and refine explan-

atory knowledge for nursing practice.

BOX 1-1 CLASSIFICATION OF RESEARCH METHODS PRESENTED IN THIS TEXTBOOK

Quantitative Research

Descriptive

Correlational

Quasi-experimental

Experimental

Qualitative Research

Phenomenological

Grounded theory

Ethnographic

Exploratory-descriptive qualitative

Historical

Outcomes Research

20 CHAPTER 1 Introduction to Nursing Research

• Quasi-experimental and experimental studies determine the effectiveness of nursing interven-

tions in predicting and controlling the outcomes desired for patients and families.

The qualitative research methods included in this text are phenomenological, grounded theory,

ethnographic, exploratory-descriptive, and historical research (see Box 1-1).

• Phenomenological research is an inductive descriptive approach used to describe an experience

as it is lived by an individual, such as the lived experience of chronic pain.

• Grounded theory research is an inductive research technique used to formulate, test, and refine

a theory about a particular phenomenon. Grounded theory research initially was described by

Glaser and Strauss (1967) in their development of a theory about grieving.

• Ethnographic research was developed by the discipline of anthropology for investigating cul-

tures through an in-depth study of the members of the culture. Health practices vary among

cultures, and these practices need to be recognized in delivering care to patients, families,

and communities.

• Exploratory-descriptive qualitative research is conducted to address an issue or problem in need

of a solution and/or understanding. Qualitative nurse researchers use this methodology to

explore an issue or problem area using varied qualitative techniques, with the intent of describ-

ing the topic of interest and promoting understanding.

• Historical research is a narrative description or analysis of events that occurred in the remote or

recent past. Through historical research, past mistakes and accomplishments are examined to

facilitate an understanding of and an effective response to present situations (Fawcett & Garity,

2009; Marshall & Rossman, 2011; Munhall, 2012; see Chapter 3).

Introduction to Outcomes Research The spiraling cost of health care has generated many questions about the quality and effective-

ness of healthcare services and patient outcomes related to these services. Consumers want to

know what services they are purchasing and whether these services will improve their health.

Healthcare policy makers want to know whether the care is cost-effective and of high quality.

These concerns have promoted the conduct of outcomes research, which focuses on examining

the results of care and determining the changes in health status for the patient (Doran, 2011;

Rettig, 1991). Some essential areas that require investigation through outcomes research

include the following: (1) patient responses to nursing and medical interventions; (2) func-

tional maintenance or improvement of physical, mental, and social functioning for the patient;

(3) financial outcomes achieved with the provision of healthcare services; and (4) patient

satisfaction with the health outcomes, care received, and healthcare providers (Doran,

2011). Nurses are playing an active role in conducting outcomes research by participating in

multidisciplinary research teams that examine the outcomes of healthcare services. This knowl-

edge provides a basis for improving the quality of care that nurses deliver in practice. Chapter 14

includes a description of outcomes research and provides guidelines for critically appraising

these types of studies.

UNDERSTANDING BEST RESEARCH EVIDENCE FOR PRACTICE

EBP involves the use of the best research evidence to support clinical decisions in practice. Best

research evidence was previously defined as a summary of the highest quality, current, empirical

knowledge in a specific area of health care that has been developed from a synthesis of quality stud-

ies (quantitative, qualitative, and outcomes) in that area. As a nurse, you make numerous clinical

decisions each day that affect the health outcomes of your patients. By using the best research

21CHAPTER 1 Introduction to Nursing Research

evidence available, you can make quality clinical decisions that will improve patients’ and families’

health outcomes. This section was developed to expand your understanding of the concept of best

research evidence for practice by providing the following: (1) a description of the strategies used to

synthesize research evidence; (2) a model of the levels of research evidence available; and (3) a link

of the best research evidence to evidence-based guidelines for practice.

Strategies Used to Synthesize Research Evidence The synthesis of study findings is a complex, highly structured process that is best conducted by at

least two or even a team of expert researchers and healthcare providers. There are various types of

research synthesis, and the type of synthesis conducted varies based on the quality and types of

research evidence available. The quality of the research evidence available in an area is dependent

on the number and validity or credibility of the studies that have been conducted in an area. The

types of research commonly conducted in nursing (see earlier) are quantitative, qualitative, and

outcomes. The research synthesis processes used to summarize knowledge varies for quantitative

and qualitative research.

Research evidence in nursing and health care is synthesized by using the following processes:

(1) systematic review; (2) meta-analysis; (3) meta-synthesis; and (4) mixed-methods systematic

review. Depending on the quantity and strength of the research findings available, nurses and

healthcare professionals use one or more of these four synthesis processes to determine the current

best research evidence in an area. Table 1-4 identifies the processes used in research synthesis, the

purpose of each synthesis process, the types of research included in the synthesis (sampling frame),

and the analytical techniques used to achieve the synthesis of research evidence (Craig & Smyth,

2012; Higgins & Green, 2008; Sandelowski & Barroso, 2007; Whittemore, 2005). Table 1-4 is also

included in the inside front cover of this textbook.

A systematic review is a structured, comprehensive synthesis of the research literature to deter-

mine the best research evidence available to address a healthcare question. A systematic review

involves identifying, locating, appraising, and synthesizing quality research evidence for expert cli-

nicians to use to promote an EBP (Craig & Smyth, 2012; Higgins & Green, 2008). Teams of expert

researchers, clinicians, and sometimes students conduct these reviews to determine the current

best knowledge for use in practice. Systematic reviews are also used in the development of national

and international standardized guidelines for managing health problems such as acute pain, hyper-

tension, and depression. Standardized guidelines are made available online, published in articles

and books, and presented at conferences and professional meetings. Some common sources for

these standardized guidelines are presented at the end of this chapter. The process for critically

appraising systematic reviews is discussed in Chapter 13.

A meta-analysis is conducted to combine or pool the results from previous quantitative studies

into a single statistical analysis that provides one of the highest levels of evidence about an inter-

vention’s effectiveness (Andrel, Keith, & Leiby, 2009; Craig & Smyth, 2012; Grove et al., 2013;

Higgins & Green, 2008). Qualitative studies do not produce statistical findings and cannot be

included in a meta-analysis. Some of the strongest evidence for using an intervention in practice

is generated from a meta-analysis of multiple, controlled quasi-experimental and experimental

studies. In addition, a meta-analysis can be performed on correlational studies to determine

the type (positive or negative) or strength of relationships among selected variables (see

Table 1-4). Because meta-analyses involve statistical analysis to combine study results, it is possible

to be objective rather than subjective when synthesizing research evidence. Many systematic

reviews conducted to generate evidence-based guidelines include meta-analyses. The process

for critically appraising a meta-analysis is discussed in Chapter 13.

22 CHAPTER 1 Introduction to Nursing Research

Qualitative research synthesis is the process and product of systematically reviewing and for-

mally integrating the findings from qualitative studies (Sandelowski & Barroso, 2007). The process

for synthesizing qualitative research is still evolving, and a variety of synthesis methods have

appeared in the literature (Barnett-Page & Thomas, 2009; Finfgeld-Connett, 2010; Higgins &

Green, 2008). In this text, the concept of meta-synthesis is used to describe the process for syn-

thesizing qualitative research. Meta-synthesis is defined as the systematic compilation and inte-

gration of qualitative study results to expand understanding and develop a unique interpretation

of study findings in a selected area. The focus is on interpretation rather than on combining study

results, as with quantitative research synthesis (see Table 1-4). The process for critically appraising

a meta-synthesis is discussed in Chapter 13.

Over the last 10 to 15 years, nurse researchers have conducted mixed-methods studies that

include quantitative and qualitative research methods (Creswell, 2014). In addition, determining

the current research evidence in an area might require synthesizing quantitative and qualitative

studies. Higgins and Green (2008) refer to this synthesis of quantitative, qualitative, and mixed-

methods studies as a mixed-methods systematic review (see Table 1-4). Mixed-methods

TABLE 1-4 PROCESSES USED TO SYNTHESIZE RESEARCH EVIDENCE

SYNTHESIS

PROCESS PURPOSE OF SYNTHESIS

TYPES OF RESEARCH

INCLUDED IN THE SYNTHESIS

(SAMPLING FRAME)

TYPE OF

ANALYSIS FOR

ACHIEVING

SYNTHESIS

Systematic

review

Use of specific, systematic methods to

identify, select, critically appraise, and

synthesize research evidence to

address a particular problem in

practice (Craig & Smyth, 2012;

Higgins & Green, 2008)

Usually includes quantitative studies

with similar methodology, such as

randomized controlled trials

(RCTs); can also include meta-

analyses focused on an area of the

practice problem

Narrative and

statistical

Meta-

analysis

Synthesis or pooling of the results from

several previous studies using

statistical analysis to determine the

effect of an intervention or strength of

relationships (Higgins & Green, 2008)

Includes quantitative studies with

similar methodology, such as

quasi-experimental and

experimental studies focused on

the effect of an intervention or

correlational studies focused on

relationships

Statistical

Meta-

synthesis

Systematic compilation and integration

of qualitative studies to expand

understanding and develop a unique

interpretation of the studies’ findings

in a selected area (Barnett-Page &

Thomas, 2009; Finfgeld-Connett,

2010; Sandelowski & Barroso, 2007)

Uses original qualitative studies and

summaries of qualitative studies to

produce the synthesis

Narrative

Mixed-

methods

systematic

review

Synthesis of findings from individual

studies conducted with a variety of

methods (quantitative, qualitative,

and mixed-methods) to determine the

current knowledge in an area (Higgins

& Green, 2008)

Synthesis of a variety of

quantitative, qualitative, and

mixed-methods studies

Narrative

23CHAPTER 1 Introduction to Nursing Research

systematic reviews might include a variety of study designs, such as qualitative research and quasi-

experimental, correlational, and/or descriptive studies (Higgins & Green, 2008). Some researchers

have conducted syntheses of quantitative and/or qualitative studies, termed integrative reviews of

research. The value of these reviews depends on the standards used to conduct them. The process

for critically appraising a mixed-method systematic review is discussed in Chapter 13.

Levels of Research Evidence The strength or validity of the best research evidence in an area depends on the quality and quan-

tity of the studies that have been conducted in an area. Quantitative studies, especially experimen-

tal studies such as the RCT, provide the strongest research evidence (see Chapter 8). Also, the

replication or repeating of studies with similar methodology increases the strength of the research

evidence generated. The levels of the research evidence are a continuum, with the highest quality of

research evidence at one end and weakest research evidence at the other (Brown, 2014; Craig &

Smyth, 2012; Melnyk & Fineout-Overholt, 2011; Figure 1-3). The systematic research reviews

and meta-analyses of high-quality experimental studies provide the strongest or best research

Strongest or best research evidence

Systematic review of experimental studies (well designed randomized controlled trials [RCTs])

Opinions of respected authorities based upon clinical evidence, reports of expert committees

Meta-analyses of experimental (RCT) and quasi-experimental studies

Integrative reviews of experimental (RCT) and quasi-experimental studies

Single experimental study (RCT)

Single quasi-experimental study

Integrative reviews of correlational and descriptive studies

Meta-analysis of correlational studies

Qualitative research meta-synthesis and meta-summaries

Single correlational study

Single qualitative or descriptive study

Weakest research evidence

FIG 1-3 Levels of Research Evidence.

24 CHAPTER 1 Introduction to Nursing Research

evidence for use by expert clinicians in practice. Meta-analyses and integrative reviews of quasi-

experimental, experimental, and outcomes studies also provide very strong research evidence for

managing practice problems. Mixed-methods systematic reviews and meta-syntheses provide

quality syntheses of quantitative, qualitative, and/or mixed-methods studies. Correlational,

descriptive, and qualitative studies often provide initial knowledge, which serves as a basis for gen-

erating quasi-experimental and outcomes studies (see Figure 1-3). The weakest evidence comes

from expert opinions, which can include expert clinicians’ opinions or the opinions expressed

in committee reports. When making a decision in your clinical practice, be sure to base that deci-

sion on the best research evidence available.

The levels of research evidence identified in Figure 1-3 (also included in the front cover of this text)

will help you determine the quality of the evidence that is available for practice. The best research

evidence generated from systematic reviews, meta-analyses, meta-syntheses, and mixed-methods sys-

tematic reviews is used to develop standardized, evidence-based guidelines for use in practice.

Introduction to Evidence-Based Guidelines Evidence-based guidelines are rigorous, explicit clinical guidelines that have been developed

based on the best research evidence available in that area. These guidelines are usually developed

by a team or panel of expert clinicians (nurses, physicians, pharmacists, and other health profes-

sionals), researchers, and sometimes consumers, policy makers, and economists. The expert panel

works to achieve consensus on the content of the guideline to provide clinicians with the best infor-

mation for making clinical decisions in practice. There has been a dramatic growth in the produc-

tion of evidence-based guidelines to assist healthcare providers in building an EBP and improving

healthcare outcomes for patients, families, providers, and healthcare agencies.

Every year, new guidelines are developed, and some of the existing guidelines are revised based

on new research evidence. These guidelines have become the gold standard (or standard of excel-

lence) for patient care, and nurses and other healthcare providers are encouraged to incorporate

these standardized guidelines into their practice. Many of these evidence-based guidelines have

been made available online by national and international government agencies, professional orga-

nizations, and centers of excellence. When selecting a guideline for practice, be sure that the guide-

line was developed by a credible agency or organization and that the reference list reflects the

synthesis of extensive number of studies.

An extremely important source for evidence-based guidelines in the United States is the

National Guideline Clearinghouse (NGC), initiated in 1998 by the AHRQ. The NGC started with

200 guidelines and has expanded to more than 1400 evidence-based guidelines (see http://www.

guideline.gov). Another excellent source of systematic reviews and evidence-based guidelines is the

Cochrane Collaboration and Library in the United Kingdom, which can be accessed at http://

cochrane.org. Professional nursing organizations, such as the Oncology Nursing Society

(http://www.ons.org) and National Association of Neonatal Nurses (http://www.nann.org), have

also developed evidence-based guidelines for nursing practice. Their websites will introduce you to

some of evidence-based guidelines that exist nationally and internationally. Chapter 13 provides

you with direction when critically appraising the quality of an evidence-based guideline and imple-

menting that guideline in your practice.

WHAT IS YOUR ROLE IN NURSING RESEARCH?

Generating a scientific knowledge base with implementation in practice requires the participation

of all nurses in various research activities. Some nurses are developers of research and conduct

25CHAPTER 1 Introduction to Nursing Research

studies to generate and refine the knowledge needed for nursing practice (Grove et al., 2013).

Others are consumers of research and use research evidence to improve their nursing practice.

The AACN (2006) and ANA (2010a, 2010b) have published statements about the roles of nurses

in research. Whatever their education or position, all nurses have roles in research; some ideas

about these roles are presented in Figure 1-4. The research role that a nurse assumes usually

expands with his or her advanced education, expertise, and career path. Nurses with associate

degrees usually have limited education about the research process and critical appraisal of studies,

so they are not included in Figure 1-4.

Nurses with a Bachelor of Science in Nursing (BSN) degree are knowledgeable about the

research process and have skills in reading and critically appraising studies. They assist with the

implementation of evidence-based guidelines, protocols, algorithms, and policies in practice. In

addition, these nurses might provide valuable assistance in identifying research problems and col-

lecting data for studies. The QSEN (2013) competencies identify such knowledge and skills as

being essential for prelicensure students.

Nurses with a Master of Science in Nursing (MSN) have the educational preparation to appraise

critically and synthesize findings from studies to revise or develop protocols, algorithms, or pol-

icies for use in practice (see Figure 1-4). They also have the ability to identify and critically appraise

the quality of evidence-based guidelines developed by national organizations. Advanced practice

nurses and nurse administrators have the ability to lead healthcare teams in making essential

changes in nursing practice and in the healthcare system based on current research evidence. Most

MSN programs provide an opportunity for students to conduct a thesis or research study under

the direction of a faculty mentor and thesis committee. However, most students do not complete

Educational Preparation

Research Functions

BSN

MSN

DNP

PhD

Post- Doctorate

Read and critically appraise studies. Use best research evidence in practice with guidance. Assist with research problem identification and data collection.

Critically appraise and synthesize studies to develop and revise protocols, algorithms, and policies for practice. Implement best research evidence in practice. Collaborate in research projects and provide clinical expertise for research.

Participate in the development of national evidence-based guidelines. Develop, implement, critically appraise, and revise as needed protocols, policies, and evidence-based guidelines used in clinical agencies. Conduct clinical studies, usually in collaboration with other nurse researchers.

Major role in conducting independent research and contributing to the empirical knowledge generated in a selected area of nursing. Obtain initial funding for research. Coordinate research teams of BSN, MSN, and DNP nurses.

Assume a full researcher role with a funded program of research. Lead and/or participate in nursing and interdisciplinary research teams. Identified as experts in their areas of research. Mentor PhD-prepared nurse researchers.

FIG 1-4 Nurses’ participation in research at various levels of education.

26 CHAPTER 1 Introduction to Nursing Research

the thesis option of their program. Therefore MSN-prepared nurses could identify problems

requiring research and sometimes conduct studies but usually do so in collaboration with other

nurse scientists (AACN, 2006; ANA 2010a, 2010b).

The doctorate in nursing can be practice-focused (doctor of nursing practice [DNP]) or

research-focused (doctor of philosophy [PhD]). DNPs are educated to have the highest level of

clinical expertise, with the ability to translate scientific knowledge for use in practice. These doc-

torally prepared nurses have advanced research and leadership knowledge to develop, implement,

evaluate, and revise evidence-based guidelines, protocols, algorithms, and policies for practice

(Clinton & Sperhac, 2006). In addition, DNP-prepared nurses have the expertise to conduct

and/or collaborate with clinical studies focused on translating evidence-based interventions into

practice.

PhD-prepared nurses assume a major role in the conduct of research and generation of nursing

knowledge in a selected area of interest (see Figure 1-4). These nurse scientists often coordinate

research teams that include DNP-, MSN-, and BSN-prepared nurses to facilitate the conduct of

quality studies in a variety of healthcare agencies. The postdoctorate-prepared nurse usually

assumes a full-time researcher role and has a funded program of research. They lead interdisciplin-

ary teams of researchers and sometimes conduct studies in multiple settings. These scientists are

often identified as experts in selected areas of research and provide mentoring of new PhD-

prepared researchers (AACN, 2006).

The following chapters in this text have been developed to expand your understanding of quan-

titative, qualitative, and outcomes research processes and increase your ability to appraise studies

critically. A critical appraisal of research involves careful examination of all aspects of a study to

judge its strengths, limitations, meaning, and significance. You will also be provided assistance in

identifying and implementing the best research evidence in practice. We think that you will find

that nursing research is an exciting adventure that holds much promise for the future practice of

nursing. We hope that this text will increase your understanding of research and the research pro-

cess and facilitate your implementation of an EBP as a nurse.

K E Y C O N C E P T S

• Research is defined as diligent, systematic inquiry to validate and refine existing knowledge and

develop new knowledge.

• Nursing research is defined as a scientific process that validates and refines existing knowledge

and generates new knowledge that directly and indirectly influences nursing practice.

• Evidence-based practice is the conscientious integration of best research evidence with clinical

expertise and patient needs and values in the delivery of quality, safe, and cost-effective

health care.

• The purposes of research in nursing include description, explanation, prediction, and control of

phenomena in practice.

• Nightingale was the first nurse researcher who developed empirical knowledge to improve prac-

tice in the nineteenth century.

• The conduct of clinical research continues to be a major focus in the twenty-first century, with

the goal of developing an evidence-based practice for nursing.

• Knowledge is acquired in nursing in a variety of ways, including tradition, authority, borrowing,

trial and error, personal experience, role modeling, intuition, reasoning and, most importantly,

research.

27CHAPTER 1 Introduction to Nursing Research

• The Quality and Safety Education for Nurses (QSEN) initiative is focused on developing the

requisite knowledge, skills, and attitudes (KSAs) of students needed to attain the required

QSEN prelicensure competencies.

• The QSEN (2013) evidence-based practice competency area is defined as “integrating the best

current evidence with clinical expertise and patient/family preferences and values for delivery of

optimal health care”.

• Quantitative research is a formal, objective, systematic process using numerical data to obtain

information about the world. This research method is used to describe, examine relationships,

and determine cause and effect.

• Qualitative research is a systematic, subjective approach used to describe life experiences and

give them meaning. Knowledge generated from qualitative research will provide meaning and

understanding of specific emotions, values, life experiences, and historical events.

• A third research method is outcomes research, which focuses on examining the end results of

care and determining the changes needed in health status for the patient and healthcare system.

• Research evidence in nursing is synthesized using the following processes: (1) systematic review;

(2) meta-analysis; (3) meta-synthesis; and (4) mixed-methods systematic review.

• A systematic review is a structured, comprehensive synthesis of quantitative studies in a par-

ticular healthcare area to determine the best research evidence available for expert clinicians

to use to promote an evidence-based practice.

• Meta-analysis is a type of study that statistically combines or pools the results from previous

studies into a single quantitative analysis that provides one of the highest levels of evidence

for an intervention’s efficacy.

• Meta-synthesis involves the systematic compilation and integration of qualitative studies to

expand understanding and develop a unique interpretation of the findings in a selected area.

• Mixed-methods systematic review is the synthesis of findings from individual studies con-

ducted with a variety of methods (quantitative, qualitative, and mixed-methods) to determine

the current knowledge in an area.

• The levels of research evidence are a continuum, with the highest quality of research evidence at

one end and weakest research evidence at the other. Systematic research reviews and meta-

analyses of quality experimental studies provide the strongest or best research evidence for prac-

tice (see Figure 1-3).

• Evidence-based guidelines are rigorous, explicit clinical guidelines that have been developed

based on the best research evidence available in that area.

• Nurses with a BSN, MSN, doctoral degree (DNP and PhD), and postdoctorate education have

clearly designated roles in research based on the breadth and depth of the research knowledge

gained during their educational programs and their clinical expertise.

REFERENCES

Agency for Healthcare Research and Quality (AHRQ),

(2013). Research tools and data. Rockville, Maryland:

Author. Retrieved June 18, 2013, from, http://www.

ahrq.gov/research/index.html.

American Association of Colleges of Nursing (AACN),

(2006). AACN position statement on nursing research.

Washington, DC: AACN. Retrieved June 17, 2013,

from, http://www.aacn.nche.edu/publications/

position/nursing-research.

American Nurses Association (ANA), (2011).

American Nurses Association research agenda.

Washington, DC: Author. Retrieved June 17, 2013

from, http://nursingworld.org/MainMenuCategories/

ThePracticeofProfessionalNursing/Improving-Your-

Practice/Research-Toolkit/ANA-Research-Agenda/

Research-Agenda-.pdf.

American Nurses Association, (2010a). Nursing: Scope and

standards of practice (2nd ed.). Washington, DC: Author.

28 CHAPTER 1 Introduction to Nursing Research

American Nurses Association, (2010b). Nursing’s social

policy statement: The essence of the profession (2nd ed.).

Washington, DC: Author.

Andrel, J. A., Keith, S. W., & Leiby, B. E. (2009). Meta-

analysis: A brief introduction. Clinical and

Translational Science, 2(5), 374–378.

Barnard, K. E. (1980). Knowledge for practice: Directions

for the future. Nursing Research, 29(4), 208–212.

Barnett-Page, E., & Thomas, J. (2009). Methods for the

synthesis of qualitative research: A critical review. BMC

Medical Research Methodology, 9, 59. http://dx.doi.org/

10.1186/147-2288-9-59.

Barnsteiner, J., Disch, J., Johnson, J., McGuinn, K.,

Chappell, K., & Swartwout, E. (2013). Diffusing QSEN

competencies across schools of nursing: The AACN/

RWJF faculty development institutes. Journal of

Professional Nursing, 29(2), 68–74.

Bauknecht, V. L. (1985). Capital commentary: NIH bill

passes, includes nursing research center. American

Nurse, 17(10), 2.

Benner, P. (1984). From novice to expert: Excellence and

power in clinical nursing practice. Menlo Park, CA:

Addison-Wesley.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Chinn, P. L., & Kramer, M. K. (2011). Integrated theory and

knowledge development in nursing (8th ed.). St. Louis:

Mosby Elsevier.

Clinton, P., & Sperhac, A. M. (2006). National agenda for

advanced practice nursing: The practice doctorate.

Journal of Professional Nursing, 22(1), 7–14.

Cocoman, A., & Murray, J. (2008). Intramuscular

injections: A review of best practice for mental health

nurses. Journal of Psychiatric and Mental Health

Nursing, 15(5), 424–434.

Cohen, B. (1984). Florence Nightingale. Scientific

American, 250(3), 128–137.

Cook, E. (1913). The life of Florence Nightingale: (Vol. 1). London, England: Macmillan.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh, Scotland:

Churchill Livingstone Elsevier.

Creswell, J. W. (2014). Research design: Qualitative,

quantitative and mixed methods approaches (4th ed.).

Thousand Oaks, CA: Sage.

Doran, D. M. (2011). Nursing sensitive outcomes: The state

of the science (2nd ed.). Sudbury, MA: Jones & Bartlett.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia:

F. A. Davis.

Finfgeld-Connett, D. (2010). Generalizability and

transferability of meta-synthesis research findings.

Journal of Advanced Nursing, 66(2), 246–254.

Glaser, B. G., & Strauss, A. L. (1967). The discovery of

grounded theory: Strategies for qualitative research.

Chicago: Aldine.

Gortner, S. R., & Nahm, H. (1977). An overview of nursing

research in the United States. Nursing Research, 26(1),

10–33.

Greenway, K. (2004). Using the ventrogluteal site for

intramuscular injection. Nursing Standard, 18(25),

39–42.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). Philadelphia, PA: Elsevier Saunders.

Herbert, R. G. (1981). Florence Nightingale: Saint, reformer

or rebel? Malabar, FL: Robert E. Krieger.

Higgins, J. P. T., & Green, S. (2008). Cochrane handbook for

systematic reviews of interventions. West Sussex,

England: Wiley-Blackwell and The Cochrane

Collaboration.

Horsley, J. A., Crane, J., Crabtree, M. K., & Wood, D. J.

(1983). Using research to improve nursing practice:

A guide. CURN project. New York: Grune & Stratton.

Institute of Medicine, (2001). Crossing the quality chasm:

A new health system for the 21st century. Washington,

DC: National Academy Press.

James, P. A., Oparil, S., Carter, B. L., Cushman, W. C.,

Denison-Himmelfard, C., Handler, J., et al. (2013).

2014 evidence-based guidelines for the management of

high blood pressure in adults: Report from the panel

members appointed to the Eight Joint National

Committee (JNC 8). JAMA, E1–E14. Dec 18; [e-pub

ahead of print]. Retrieved January 5, 2014 from, http://

dx.doi.org/10.1001/jama.2013.284427.

Kaplan, A. (1964). The conduct of inquiry; Methodology for

behavioral science. San Francisco: Chandler.

Kerlinger, F. N., & Lee, H. B. (2000). Foundations of

behavioral research (4th ed.). Fort Worth, TX: Harcourt

College Publishers.

Lee, S., Faucett, J., Gillen, M., Krause, N., & Landry, L.

(2013). Risk perception of musculoskeletal injury

among critical care nurses. Nursing Research, 62(1),

36–44.

Manojlovich, M., Sidani, S., Covell, C. L., &

Antonakos, C. L. (2011). Nurse dose: Linking staffing

variables to adverse patient outcomes. Nursing

Research, 60(4), 214–220.

Marshall, C., & Rossman, G. B. (2011). Designing

qualitative research (5th ed.). Thousand Oaks,

CA: Sage.

29CHAPTER 1 Introduction to Nursing Research

McMurrey, P. H. (1982). Toward a unique knowledge base

in nursing. Image, 14(1), 12–15.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-

based practice in nursing and healthcare: A guide to

best practice (2nd ed.). Philadelphia: Lippincott,

Williams, & Wilkins.

Munhall, P. L. (2012). Nursing research:

A qualitative perspective (5th ed.). Sudbury, MA: Jones

& Bartlett.

National Heart, Lung, and Blood Institute, (2003).

The seventh report of the Joint National Committee

on Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure (JNC 7). Retrieved

June 11, 2013 from, www.nhlbi.nih.gov/guidelines/

hypertension.

National Institute of Nursing Research, (2011). Bringing

science to life: NINR strategic plan. Retrieved June 17,

2013 from, https://www.ninr.nih.gov/sites/www.ninr.

nih.gov/files/ninr-strategic-plan-2011.pdf.

National Institute of Nursing Research, (2013). About the

NINR. Retrieved June 18, 2013 from, http://www.ninr.

nih.gov/aboutninr/.

Nicoll, L. H., & Hesby, A. (2002). Intramuscular injections:

An integrative research review and guideline for

evidence-based practice. Applied Nursing Research, 16

(2), 149–162.

Nightingale, F. (1859). Notes on nursing: What it is, and

what it is not. Philadelphia: Lippincott.

Oakley, K. (2010). Nursing by the numbers. Occupational

Health, 62(4), 28–29.

Palmer, I. S. (1977). Florence Nightingale: Reformer,

reactionary, researcher. Nursing Research, 26(2),

84–89.

Quality, Safety Education for Nurses (QSEN), (2013). Pre-

licensure knowledge, skills, and attitudes (KSAs).

Retrieved February 17, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas/.

Rettig, R. (1991). History, development, and importance

to nursing of outcomes research. Journal of Nursing

Quality Assurance, 5(2), 13–17.

Rodger, M. A., & King, L. (2000). Drawing up and

administering intramuscular injections: A review

of the literature. Journal of Advanced Nursing, 31(3),

574–582.

Rush, K. L., Watts, W. E., & Janke, R. (2013). Rural and

urban older adults’ perspectives of strength in their

daily lives. Applied Nursing Research, 26(1), 10–16.

Sackett, D. L., Straus, S. E., Richardson, W. S.,

Rosenberg, W., & Haynes, R. B. (2000). Evidence-based

medicine: How to practice and teach EBM (2nd ed.).

London: Churchill Livingstone.

Sandelowski, M., & Barroso, J. (2007). Handbook for

synthesizing qualitative research. New York: Springer.

See, E. M. (1977). The ANA and research in nursing.

Nursing Research, 26(3), 165–171.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002).

Experimental and quasi-experimental designs for

generalized causal inference. Chicago: Rand McNally.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Standing, M. (2009). A new critical framework for

applying hermeneutic phenomenology. Nurse

Researcher, 16(4), 20–30.

Stetler, C. B. (2001). Updating the Stetler model of

research utilization to facilitate evidence-based

practice. Nursing Outlook, 49(6), 272–279.

U.S. Department of Health and Human Services, (U.S.

DHHS) (2000). Healthy people 2010: Understanding

and improving health. Washington, DC: U.S. Depart-

ment of Health and Human Services.

U.S. Department of Health and Human Services, (U.S.

DHHS) (2013). Healthy people 2020: Topics and

objectives. Retrieved June 18, 2013 from, http://www.

healthypeople.gov/2020/topicsobjectives2020/

default.aspx.

Weber, M. A., Schiffrin, E. L., White, W. B., Mann, S.,

Lindholm, L. H., Kenerson, J. G., et al. (2014). Clinical

practice guidelines for the management of

hypertension in the community: A statement by the

American Society of Hypertension and the

International Society of Hypertension. Journal of

Hypertension, 32(1), 3–15.

Werley, H. H., & Fitzpatrick, J. J. (1983). Annual review of

nursing research (Vol. 1). New York: Springer.

Whittemore, R. (2005). Combining evidence in nursing

research: Methods and implications. Nursing Research,

54(1), 56–62.

30 CHAPTER 1 Introduction to Nursing Research

C H A P T E R

2 Introduction to Quantitative Research

C H A P T E R OV E R V I E W

What Is Quantitative Research?, 32

Types of Quantitative Research, 33

Defining Terms Relevant to Quantitative

Research, 35

Problem-Solving and Nursing Processes:

Basis for Understanding the Quantitative

Research Process, 38

Comparing Problem Solving with the Nursing

Process, 38

Comparing the Nursing Process with the

Research Process, 39

Identifying the Steps of the Quantitative Research

Process, 40

Research Problem and Purpose, 41

Review of Relevant Literature, 41

Study Framework, 42

Research Objectives, Questions, or

Hypotheses, 43

Study Variables, 44

Study Design, 45

Population and Sample, 46

Measurement Methods, 46

Data Collection, 47

Data Analysis, 47

Discussion of Research Outcomes, 48

Reading Research Reports, 49

Sources of Research Reports, 50

Content of Research Reports, 51

Tips for Reading Research Reports, 54

Practice Reading Quasi-Experimental and

Experimental Studies, 55

Quasi-Experimental Study, 56

Experimental Study, 60

Key Concepts, 63

References, 64

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Define terms relevant to the quantitative research

process—basic research, applied research, rigor,

and control.

2. Compare and contrast the problem-solving

process, nursing process, and research

process.

3. Identify the steps of the quantitative research

process in descriptive, correlational, quasi-

experimental, and experimental published studies.

4. Read quantitative research reports.

5. Conduct initial critical appraisals of quantitative

research reports.

K E Y T E R M S

Abstract, p. 51

Analyzing a research report, p. 55

Applied research, p. 35

Assumptions, p. 42

Basic research, p. 35

Bias, p. 37

31

Comprehending a research

report, p. 55

Conceptual definition, p. 44

Control, p. 36

Correlational research, p. 33

Data analysis, p. 47

Data collection, p. 47

Descriptive research, p. 33

Design, p. 36

Experiment, p. 32

Experimental research, p. 34

Extraneous variables, p. 37

Framework, p. 42

Generalization, p. 48

Interpretation of research

outcomes, p. 48

Limitations, p. 48

Measurement, p. 46

Nursing process, p. 38

Operational

definition, p. 44

Pilot study, p. 45

Population, p. 46

Precision, p. 36

Problem-solving

process, p. 38

Process, p. 38

Quantitative research, p. 32

Quantitative research

process, p. 40

Quasi-experimental

research, p. 34

Reading a research

report, p. 54

Research problem, p. 41

Research process, p. 39

Research purpose, p. 41

Research report, p. 49

Review of relevant

literature, p. 41

Rigor, p. 36

Sample, p. 46

Sampling, p. 37

Setting, p. 38

Skimming a research

report, p. 54

Theory, p. 42

Variables, p. 44

What do you think of when you hear the word research? Frequently, the idea of experimentation or

study comes to mind. Typical features of an experiment include randomizing subjects into groups,

collecting data, and conducting statistical analyses. You may think of researchers conducting a study

to determine the effectiveness of an intervention, such as determining the effectiveness of a walking

exercise program on body mass index (BMI) of patients with type 2 diabetes. These ideas are asso-

ciated with quantitative research. Quantitative research includes specific steps that are detailed in

research reports. Reading and critically appraising quantitative studies require learning new terms,

understanding the steps of the quantitative research process, and applying a variety of analytical skills.

This chapter provides an introduction to quantitative research to help develop expertise in

reading and understanding quantitative research reports. Relevant terms are defined, and the

problem-solving and nursing processes are presented to provide a background for understanding

the quantitative research process. The steps of the quantitative research process are introduced, and

a descriptive correlational study is presented as an example to promote understanding of the pro-

cess. Also included are a discussion of the critical thinking skills needed for reading research reports

and guidelines for conducting an initial critical appraisal of these quantitative research reports.

The chapter concludes with the identification of the steps of the research process from published

quasi-experimental and experimental studies, with an initial critical appraisal of these studies.

WHAT IS QUANTITATIVE RESEARCH?

Quantitative research is a formal, objective, rigorous, systematic process for generating numerical

information about the world. Quantitative research is conducted to describe new situations,

events, or concepts; examine relationships among variables; and determine the effectiveness of

treatments or interventions on selected health outcomes in the world. Some examples include:

1. Describing the spread of flu cases each season and their potential influence on local and global

health (descriptive study)

2. Examining the relationships among the variables—for example, minutes watching television

per week, minutes playing video games per week, and body mass index (BMI) of a school-

age child (correlational study)

32 CHAPTER 2 Introduction to Quantitative Research

3. Determining the effectiveness of calcium with vitamin D3 supplements on the bone density of

adults (quasi-experimental study).

The classic experimental designs to test the effectiveness of treatments were originated by Sir

Ronald Fisher (1935). He is noted for adding structure to the steps of the quantitative research

process with ideas such as the hypothesis, research design, and statistical analysis. Fisher’s studies

provided the groundwork for what is now known as experimental research.

Throughout the years, a number of other quantitative approaches have been developed.

Campbell and Stanley (1963) developed quasi-experimental approaches to study the effects of

treatments under less controlled conditions. Karl Pearson (Porter, 2004) developed statistical

approaches for examining relationships between variables, which were used in analyzing

data when correlational research was conducted. The fields of sociology, education, and

psychology are noted for their development and expansion of strategies for conducting descriptive

research. A broad range of quantitative research approaches is needed to develop the empirical

knowledge for building evidence-based practice (EBP) in nursing (Brown, 2014; Craig &

Smyth, 2012). EBP is introduced in Chapter 1 and detailed in Chapter 13. EBP is essential for pro-

moting quality, safe outcomes for patients and families, nursing education and practice, and the

healthcare system (Doran, 2011; Quality and Safety Education for Nurses [QSEN], 2013;

Sherwood & Barnsteiner, 2012). Understanding the quantitative research process is essential for

meeting the QSEN (2013) competencies for undergraduate nursing students, which are focused

on patient-centered care, teamwork and collaboration, EBP, quality improvement (QI), safety,

and informatics. This section introduces you to the different types of quantitative research and

provides definitions of terms relevant to the quantitative research process.

Types of Quantitative Research Four common types of quantitative research are included in this text:

• Descriptive

• Correlational

• Quasi-experimental

• Experimental

The type of quantitative research conducted is influenced by the current knowledge of a research

problem. When little knowledge is available, descriptive studies often are conducted. As the knowl-

edge level increases, correlational, quasi-experimental, and experimental studies are conducted.

Descriptive Research Descriptive research is the exploration and description of phenomena in real-life situations. It

provides an accurate account of characteristics of particular individuals, situations, or groups

(Brown, 2014; Fawcett & Garity, 2009; Kerlinger & Lee, 2000). Descriptive studies are usually con-

ducted with large numbers of subjects or study participants, in natural settings, with no manip-

ulation of the situation. Through descriptive studies, researchers discover new meaning, describe

what exists, determine the frequency with which something occurs, and categorize information in

real-world settings. The outcomes of descriptive research include the identification and descrip-

tion of concepts, identification of possible relationships among concepts, and development of

hypotheses that provide a basis for future quantitative research.

Correlational Research

Correlational research involves the systematic investigation of relationships between or among

variables. When conducting this type of study, researchers measure selected variables in a sample

and then use correlational statistics to determine the relationships among the study variables.

33CHAPTER 2 Introduction to Quantitative Research

Using correlational analysis, the researcher is able to determine the degree or strength and type

(positive or negative) of a relationship between two variables. The strength of a relationship varies,

ranging from �1 (perfect negative correlation) to +1 (perfect positive correlation), with 0 indicat- ing no relationship (Grove, 2007).

A positive relationship indicates that the variables vary together; that is, both variables increase

or decrease together. For example, research has shown that the more people smoke, the more lung

damage they experience. A negative relationship indicates that the variables vary in opposite direc-

tions; thus as one variable increases, the other will decrease (Grove, Burns, & Gray, 2013). For

example, research has shown as the number of smoking pack-years (number of years smoked times

the number of packs smoked per day) increases, people’s life spans usually decrease, demonstrating

a negative relationship. The primary intent of correlational studies is to explain the nature of rela-

tionships in the real world, not to determine cause and effect. The focus of correlational research

is on describing relationships, not testing the effectiveness of interventions. However, the re-

lationships identified with correlational studies are the means for generating hypotheses to guide

quasi-experimental and experimental studies that do focus on examining cause and effect

relationships.

Quasi-Experimental Research

The purpose of quasi-experimental research is to examine causal relationships or determine the

effect of one variable on another. Thus these studies involve implementing a treatment or inter-

vention and examining the effects of this intervention using selected methods of measurement

(Shadish, Cook, & Campbell, 2002). In nursing research, a treatment is an intervention imple-

mented by researchers to improve the outcomes of clinical practice. For example, a treatment

of a swimming exercise program might be implemented to improve the balance and muscle

strength of older women with osteoarthritis. Quasi-experimental studies differ from experimental

studies by the level of control achieved by the researcher. These studies usually lack a certain

amount of control over the manipulation of the treatment, management of the setting, and/or

selection of the subjects. When studying human behavior, especially in clinical settings, researchers

frequently are unable to select the subjects randomly or manipulate or control certain variables

related to the treatment, subjects, or the setting. As a result, nurse researchers conduct more

quasi-experimental studies than experimental studies. Control is discussed in more detail later

in this chapter.

Experimental Research Experimental research is an objective, systematic, highly controlled investigation conducted

for the purpose of predicting and controlling phenomena in nursing practice. In an ex-

perimental study, causality between the independent (treatment) and dependent (outcome)

variables is examined under highly controlled conditions (Shadish et al., 2002). Experimental

research is the most powerful quantitative method because of the rigorous control of variables.

The three main characteristics of experimental studies are the following: (1) controlled manip-

ulation of at least one treatment variable (independent variable); (2) exposure of some of

the subjects to the treatment (experimental group) and no exposure of the remaining subjects

(control group); and (3) random assignment of subjects to the control or experimental group.

Random selection of subjects and the conduct of the study in a laboratory or research facility

strengthen control in an experimental study. The degree of control achieved in experimental

studies varies according to the population studied, variables examined, and environment of

the study.

34 CHAPTER 2 Introduction to Quantitative Research

Defining Terms Relevant to Quantitative Research Understanding quantitative research requires comprehension of the following important terms—

basic research, applied research, rigor, and control. These terms are defined in the following sections,

with examples provided from published studies.

Basic Research Basic research is sometime referred to as pure research. It includes scientific investigations

conducted for the pursuit of knowledge for knowledge’s sake or for the pleasure of learning and

finding truth (Miller & Salkind, 2002). Basic scientific investigations seek new knowledge about

health phenomena, with the hope of establishing general scientific principles. The purpose of basic

research is to generate and refine theory; thus the findings frequently are not directly useful in prac-

tice (Wysocki, 1983). Basic nursing research might include laboratory investigations with animals

or humans to promote further understanding of physiological functioning, genetic and inheritable

disorders, and pathological processes. These studies might focus on increasing our understanding

of oxygenation, perfusion disorders, fluid and electrolyte imbalances, acid-base status, immune

system disorders, eating and exercise patterns, sleeping disorders, and pain and comfort status.

You might conduct an initial critical appraisal of quantitative studies and identify whether basic

or applied research was conducted. Sharma, Ryals, Gajewski, and Wright (2010) conducted a basic

study to determine the effect of aerobic exercise on analgesia and neurotropin-3 synthesis on

chronic pain using female mice. The researchers noted that the literature and nurses in clinical

practice supported using aerobic exercise to reduce pain and improve functioning in those with

chronic pain, but the molecular basis for the positive actions of exercise was not clearly under-

stood. Sharma et al. (2010) conducted a basic experimental study; the steps of this study are

provided as an example at the end of this chapter.

Sharma and colleagues’ (2010) study demonstrates the importance of laboratory research to

increase our understanding of the effects of treatments on cellular pathological processes. Basic

research using animals is often conducted to provide an increased understanding of the genetics

of health problems and establish a basis for further human research in this area. A major force in

genetic research is the National Human Genome Research Institute (NHGRI, 2013), which plans

and conducts a broad program of laboratory research to increase our understanding of human

genetic makeup, genetics of diseases, and potential gene therapy. This basic research provides

a basis for conducting applied “clinical research to translate genomic and genetic research into a

greater understanding of human genetic disease, and to develop better methods for the detection,

prevention, and treatment of heritable and genetic disorders” (NHGRI, 2013).

Applied Research Applied research is also called practical research, which includes scientific investigations con-

ducted to generate knowledge that will directly influence or improve clinical practice. The purpose

of applied research is to solve problems, make decisions, and/or predict or control outcomes in

real-life practice situations. The findings from applied studies can also be invaluable to policy

makers as a basis for making changes to address health and social problems. Many of the studies

conducted in nursing are applied studies because researchers have chosen to focus on clinical prob-

lems and the testing of nursing interventions to improve patient outcomes. Applied research also is

used to test theory and validate its usefulness in clinical practice (Fawcett & Garity, 2009).

Researchers often examine the new knowledge discovered through basic research for its usefulness

in practice by applied research, making these approaches complementary.

35CHAPTER 2 Introduction to Quantitative Research

Pinto, Hickman, Clochesy, and Buchner (2013) conducted an applied study to determine the

effectiveness of an avatar-based, depression, self-management technology intervention in treating

depressive symptoms in young adults. This intervention is called “Electronic Self-Management

Resource Training for Mental Health” (eSMART-MH). “eSMART-MH is a novel avatar-based

depression self-management intervention in which young adults interact with virtual healthcare

providers and a virtual health coach in a virtual primary care environment to practice effective

communication about depression symptoms and receive tailored behavioral feedback” (Pinto

et al., 2013, p. 46). The researchers found that the eSMART-MH intervention demonstrated initial

efficacy and was developmentally appropriate for depression self-management in young adults.

These applied study findings, combined with the findings of additional studies in this area, have

the potential to generate important knowledge for the delivery of evidence-based care to young

adults experiencing depression. The greater the rigor and control implemented in these types

of applied studies, the higher the quality of the research evidence developed for practice.

Rigor in Quantitative Research

Rigor is the striving for excellence in research; it requires discipline, adherence to detail, strict accu-

racy, and precision. A rigorously conducted quantitative study has precise measuring tools, a rep-

resentative sample, and a tightly controlled study design. Critically appraising the rigor of a study

involves examining the reasoning and precision used in conducting the study. Logical reasoning,

including deductive and inductive reasoning (see Chapter 1), is essential to the development of

quantitative studies (Chinn & Kramer, 2011). The research process, discussed later in this chapter,

includes specific steps that are rigorously developed with meticulous detail and are logically linked

in descriptive, correlational, quasi-experimental, and experimental studies.

Another aspect of rigor is precision, which encompasses accuracy, detail, and order.

Precision is evident in the concise statement of the research purpose and detailed development

of the study design. However, the most explicit example of precision is the measurement

or quantification of the study variables. For example, a researcher might use a cardiac

monitor to measure and record the heart rate of subjects into a database during an exercise

program, rather than palpating a radial pulse for 30 seconds and recording it on a data

collection sheet.

Control in Quantitative Research Control involves the imposing of rules by researchers to decrease the possibility of error, thereby

increasing the probability that the study’s findings are an accurate reflection of reality. The rules

used to achieve control in research are referred to as design. Thus quantitative research includes

various degrees of control, ranging from uncontrolled to highly controlled, depending on the type

of study (Table 2-1). Descriptive and correlational studies are rigorously conducted but are often

designed with minimal researcher control because subjects are examined as they exist in their nat-

ural setting, such as home, work, school, or health clinic.

Quasi-experimental studies focus on determining the effectiveness of a treatment (indepen-

dent variable) in producing a desired outcome (dependent variable) in a partially controlled set-

ting. Thus these studies are conducted with more control of extraneous variables, selection of

subjects and settings, and development and implementation of the treatment or intervention

(see Table 2-1). However, experimental studies are the most highly controlled type of quantitative

research conducted to examine the effect of interventions on dependent variables. Experimental

studies often are conducted on subjects in experimental units in healthcare agencies or on ani-

mals in laboratory settings, such as the study by Sharma and associates (2010), which used mice

36 CHAPTER 2 Introduction to Quantitative Research

to examine the effects of aerobic exercise on chronic pain (see Table 2-1). The following elements

are areas for control in quantitative studies:

• Extraneous variables

• Sampling process

• Selection of setting

• Development and implementation of the study intervention

Extraneous Variables Through control, the researcher can reduce the influence of extraneous variables. Extraneous vari-

ables exist in all studies and can interfere with obtaining a clear understanding of the relationships

among the study variables. For example, if a study focused on the effect of relaxation therapy on the

perception of incisional pain, the researchers would have to control the extraneous variables, such

as type of surgical incision and time, amount, and type of pain medication administered after sur-

gery, to prevent their influence on the patient’s perception of pain. Selecting only patients with

abdominal incisions who are hospitalized and receiving only one type of pain medication intra-

venously after surgery would control some of these extraneous variables. Controlling extraneous

variables enables researchers to determine the effects of an intervention or treatment on study out-

comes more accurately.

Sampling Sampling is a process of selecting participants who are representative of the population being stud-

ied. Random sampling usually provides a sample that is representative of a population because

each member of the population is selected independently and has an equal chance, or probability,

of being included in the study. In quantitative research, random and nonrandom samples are used.

A randomly selected sample is very difficult to obtain in nursing research, so quantitative studies

often are conducted with nonrandom samples. To increase the control and rigor of a study and

decrease the potential for bias (slanting of findings away from what is true or accurate), the sub-

jects who are initially selected with a nonrandom sampling method are often randomly assigned to

the treatment group or the control (no treatment) group in quasi-experimental and experimental

studies. For example, Pinto and co-workers (2013) initially obtained their sample of young

adolescents using a nonrandom convenience sampling method. However, the study design was

strengthened by the random assignment of these adolescents to receive the avatar-based, depres-

sion, self-management intervention (experimental group) or standard care of education on

healthy living (comparison or control group).

TABLE 2-1 CONTROL IN QUANTITATIVE RESEARCH

TYPE OF QUANTITATIVE

RESEARCH

RESEARCHER CONTROL OF INTERVENTION

AND EXTRANEOUS VARIABLES RESEARCH SETTING

Descriptive No intervention

Limited or no control of extraneous variables

Natural or partially controlled

setting

Correlational No intervention

Limited or no control of extraneous variables

Natural or partially controlled

setting

Quasi-experimental Controlled intervention

Rigorous control of extraneous variables

Partially controlled setting

Experimental Highly controlled intervention and extraneous

variables

Research unit or laboratory

setting

37CHAPTER 2 Introduction to Quantitative Research

Research Settings

The setting is the location in which a study is conducted. There are three common settings for

conducting research—natural, partially controlled, and highly controlled (see Table 2-1). A natural

setting, or field setting, is an uncontrolled, real-life situation or environment. Conducting a study in

a natural setting means that the researcher does not manipulate or change the environment for the

study. Descriptive and correlational studies often are conducted in natural settings. A partially

controlled setting is an environment that the researcher has manipulated or modified in some

way. An increasing number of nursing studies are occurring in partially controlled settings to limit

the effects of extraneous variables on the studyoutcomes. A highlycontrolled setting is an artificially

constructed environment developed for the sole purpose of conducting research. Laboratories,

research or experimental centers, and test units in hospitals or other healthcare agencies are highly

controlled settings in which experimental studies are often conducted. This type of setting reduces

the influence of extraneous variables, which enables the researcher to examine the effect of one var-

iable on another accurately. Chapter 9 presents a more detailed discussion of samples and settings.

Study Interventions Quasi-experimental and experimental studies examine the effect of an independent variable or

intervention on a dependent variable or outcome. More intervention studies are being conducted

in nursing to establish an EBP. Controlling the development and implementation of a study inter-

vention increases the validity of the study design and credibility of the findings. A study interven-

tion needs to be (1) clearly and precisely developed, (2) consistently implemented, and (3)

examined for effectiveness through quality measurement of the dependent variables. The detailed

development of a quality intervention and the consistent implementation of this intervention are

known as intervention fidelity (Grove et al., 2013; Morrison, et al., 2009). Chapter 8 provides

guidelines for critically appraising interventions in studies.

PROBLEM-SOLVING AND NURSING PROCESSES: BASIS FOR UNDERSTANDING THE QUANTITATIVE RESEARCH PROCESS

Research is a process, and it is similar in some ways to other processes. Therefore the background

acquiredearly innursingeducationinproblemsolvingandthenursing processalsoisusefulinresearch.

A process includes a purpose, series of actions, and goal. The purpose provides direction for the imple-

mentation of a series of actions to achieve an identified goal. The specific steps of the process can

be revised and re-implemented to reach the endpoint or goal. Table 2-2 links the steps of the

problem-solving process, nursing process, and research process. Relating the research process to the

problem-solvingandthenursing processesmaybehelpfulinunderstandingthestepsofthequantitative

research process.

Comparing Problem Solving with the Nursing Process The problem-solving process involves the systematic collection of data to identify a problem, dif-

ficulty, or dilemma; determination of goals related to the problem; identification of possible

approaches or solutions to achieve those goals (plan); implementation of the selected solutions;

and evaluation of goal achievement (Chinn & Kramer, 2011). Problem solving frequently is used

in daily activities and nursing practice. For example, you use problem solving when you select your

clothing, decide where to live, or turn a patient with a fractured hip.

The nursing process is a subset of the problem-solving process. The steps of the nursing process

are assessment, diagnosis, plan, implementation, evaluation, and modification (see Table 2-2).

Assessment involves the collection and interpretation of subjective data (health history) and

38 CHAPTER 2 Introduction to Quantitative Research

objective data (physical exam) for the development of nursing diagnoses. These diagnoses guide

the remaining steps of the nursing process, just as the step of identifying the problem directs the

remaining steps of the problem-solving process. The planning step in the nursing process is

the same as in the problem-solving process. Both processes involve implementation (putting

the plan into action) and evaluation (determining the effectiveness of the process). If the process

is ineffective, nurses need to review all steps and revise (modify) them as necessary to achieve

quality outcomes for the patient and family (Wilkinson, 2012). Nurses implement the nursing

process until the problems and diagnoses are resolved, and the identified goals are achieved.

Comparing the Nursing Process with the Research Process The nursing process and research process have important similarities and differences. The two pro-

cesses are similar because they both involve abstract critical thinking and complex reasoning. These

processes help identify new information, discover relationships, and make predictions about phe-

nomena. In both processes, information is gathered, observations are made, problems are identi-

fied, plans are developed (methodology), and actions are taken (data collection and analysis). Both

processes are reviewed for effectiveness and efficiency—the nursing process is evaluated, and out-

comes are determined in the research process (see Table 2-2). Implementing the two processes

expands and refines the user’s knowledge. With this growth in knowledge and critical thinking,

the user can implement increasingly complex nursing processes and studies.

The research and nursing processes also have definite differences. Knowledge of the nursing

process will assist you in understanding the research process. However, the research process is

more complex than the nursing process and involves the rigorous application of a variety of

research methods (Grove et al., 2013). The research process also has a broader focus than that

of the nursing process, in which the nurse focuses on a specific patient and family. During the

quantitative research process, the researcher focuses on large groups of individuals, such as a pop-

ulation of patients with hypertension. In addition, researchers must be knowledgeable about the

world of nursing to identify problems that require study. This knowledge comes from clinical and

other personal experiences and by conducting a review of the literature.

TABLE 2-2 COMPARISON OF THE PROBLEM-SOLVING PROCESS, NURSING PROCESS, AND RESEARCH PROCESS

PROBLEM-SOLVING

PROCESS NURSING PROCESS RESEARCH PROCESS

Data collection Assessment

Data collection (objective and

subjective data)

Data interpretation

Knowledge of nursing world

Clinical experiences

Literature review

Problem definition Nursing diagnosis Problem and purpose identification

Plan

Setting goals

Identifying solutions

Plan

Setting goals

Planning interventions

Methodology

Design

Sample

Measurement methods

Data collection

Data analysis

Implementation Implementation Implementation

Evaluation and

revision

Evaluation and modification Outcomes, communication, and synthesis of

study findings to promote evidence-based

nursing practice

39CHAPTER 2 Introduction to Quantitative Research

The theoretical underpinnings of the research process are much stronger than those of the nurs-

ing process. All steps of the research process are logically linked to each other, as well as to the the-

oretical foundations of the study. The conduct of research requires greater precision, rigor, and

control than what are needed in the implementation of the nursing process. The outcomes from

research frequently are shared with a large number of nurses and other healthcare professionals

through presentations and publications. In addition, the outcomes from several studies can be

synthesized to provide sound evidence for nursing practice (Melnyk & Fineout-Overholt, 2011).

IDENTIFYING THE STEPS OF THE QUANTITATIVE RESEARCH PROCESS

The quantitative research process involves conceptualizing a research project, planning and

implementing that project, and communicating the findings. Figure 2-1 identifies the steps of

the quantitative research process that are usually included in a research report. The figure illus-

trates the logical flow of the process as one step builds progressively on another. The steps of

the quantitative research process are briefly introduced here; Chapters 4 to 11 discuss them in more

detail. The descriptive correlational study conducted by Dickson, Howe, Deal, and McCarthy

(2012) on the relationships of work, self-care, and quality of life in a sample of older working adults

Research Problem and Purpose

Review of Relevant Literature

Study Framework

Research Objectives, Questions, or Hypotheses

Study Variables

Study Design Generating

Further Research

Population and Sample

Measurement Methods

Data Collection

Data Analysis

Discussion of Research Outcomes

FIG 2-1 Steps of the Quantitative Research Process.

40 CHAPTER 2 Introduction to Quantitative Research

with cardiovascular disease (CVD) is used as an example to introduce the steps of the quantitative

research process.

Research Problem and Purpose A research problem is an area of concern in which there is a gap in the knowledge needed for nurs-

ing practice. The problem statement in a study usually identifies an area of concern for a particular

population that requires investigation. Research is then conducted to generate essential knowledge

that addresses the practice concern, with the ultimate goal of developing sound research evidence

for nursing practice(Brown, 2014; Craig & Smyth, 2012).The researchproblemis usually broadand

could provide the basis for several studies. The research purpose is generated from the problem and

identifies the specific focus or goal of the study. The focus of a quantitative study might be to iden-

tify, describe, or explain a situation; predict a solution to a situation; or control a situation to pro-

duce positive outcomes in practice. The purpose includes the variables, population, and often the

setting for the study. Chapter 5 presents a detailed discussion of the research problem and purpose.

Review of Relevant Literature Researchers conduct a review of relevant literature to generate a picture of what is known and not

known about a particular problem and to document why a study needs to be conducted. Relevant

literature includes only those sources that are pertinent to or highly important in providing the in-

depth knowledge needed to study a selected problem (Fawcett & Garity, 2009). Often, the literature

RESEARCH EXAMPLE

Problem and Purpose

Research Study Excerpt Dickson and colleagues (2012) clearly expressed their study research problem and purpose in the following study

excerpts. The problem of older workers with CVD affects millions of people and the need for additional research

is identified. The purpose is focused on the concern identified in the problem and clearly indicates that the goal

of the study is to describe and examine relationships among variables important to working individuals with CVD.

Research Problem “According to the Bureau of Labor Statistics (2008), the American workforce is aging. By 2015, the number of

workers aged 55 years or more will reach 31.2 million, a 72% increase from 2000. As a result, health problems

associated with the aging process, such as cardiovascular disease (CVD), present new health and safety chal-

lenges for older workers. More than 3.5 million workers have CVD. . . . However, older workers with CVD are

3 times more likely to report work limitations than those without CVD. . . . Older workers with CVD also report

increased rates of absenteeism and longer periods of disability from work. Furthermore, within 6 years after

a recognized heart attack, approximately 22% of men and 46% of the women report being disabled from work

(American Heart Association, 2005). . . . For the large segment of the American workforce with CVD, self-care

that entails adhering to treatment regimens while working and managing symptoms is critical to their quality

of life. . . . Few studies exist to guide clinicians in supporting ongoing employment among patients

with CVD.” Dickson et al., 2012, pp. 6-7

Research Purpose “Therefore, the purpose of this study was to examine the self-care behaviors of adherence to medication,

diet, exercise, and symptom monitoring of older workers with CVD, and explore the relationships among

job characteristics (job demands, job control, and workplace support), self-care, and quality of life.”

Dickson et al., 2012, p. 7

41CHAPTER 2 Introduction to Quantitative Research

review section concludes with a summary paragraph that indicates the current knowledge of a

problem area and identifies the additional research that is needed to generate essential evidence

for practice. Chapter 6 provides guidelines for reviewing relevant literature in research.

Study Framework A framework is the abstract, theoretical basis for a study that enables the researcher to link the

findings to nursing’s body of knowledge. In quantitative research, the framework is a testable

theory that has been developed in nursing or another discipline, such as psychology, physiology,

pathology, or sociology. A theory consists of assumptions, an integrated set of defined concepts,

and relational statements that present a view of a phenomenon and can be used to describe,

explain, predict, or control the phenomenon (Chinn & Kramer, 2011). Assumptions are state-

ments that are taken for granted or are considered true, even though they have not been scientif-

ically tested, and provide a basis for the phenomenon described by the theory. A concept is a term

that abstractly names and describes an object or phenomenon, providing it with a separate identity

and meaning. The study framework by Dickson and co-workers (2012) included the concept of

self-care, which was conceptualized as a naturalistic, decision-making process implemented to

improve an individual’s health and quality of life (see the study framework presented in the fol-

lowing excerpt). The relational statements in theories identify the links between two or more con-

cepts that are tested in research. Thus, in quantitative studies, researchers test selected relational

statements of the theory, not the entire theory. A study framework can be expressed as a map or a

diagram of the relationships that provide the basis for a study and is described in the research

report, or the framework can be presented in narrative format. Chapter 7 provides you with

a background for understanding and critically appraising study frameworks.

Dickson and associates (2012, pp. 6-7) organized their literature review using the variables identified in their

study purpose. They concisely covered relevant studies that provided a basis for their study methodology

and presented theories that provided the framework for the study:

“Individuals with chronic illnesses such as CVD [cardiovascular disease] play a central role in managing their

health through self-care (Bodenheimer, Lorig, Holman, & Grumbach, 2002), which encompasses adherence

to medication regimens, diet restrictions, and symptom monitoring for the purpose of maintaining physio-

logic stability, and symptom management in response to symptoms when they occur. Successful self-care

is associated with improved health outcomes, including fewer hospitalizations, less emergency department

use, and improved quality of life. . . . Individuals with CVD make decisions on a daily basis about whether to

take medication, adhere to diet restrictions, or act early on symptoms, and these decisions may vary depend-

ing on the situation faced by the individual (e.g., whether at home or work). . . . For workers with CVD, job-

level factors (job demands, job control, and workplace support) and work organization (e.g., work practices

and organizational policies) may further complicate one’s ability to engage in self-care (i.e., adhere to med-

ication regimens and diet restrictions, attend doctor’s appointments) during work hours and while on busi-

ness travel or attending work events. For the older worker with CVD, continuing employment while adhering

to a complex treatment regimen may be difficult (Weijman et al., 2005), but the relationship between work

and adherence is not known. . . .

Experts contend that older workers may be particularly vulnerable to changes in work process that include

extended shifts, overtime, and increased work demands of productivity. . . . The National Institute of Aging and

the National Institute of Occupational Safety and Health (2008) have both cited the need to understand how

working conditions affect the health of the aging workforce, including the identification of risk factors

that may disproportionately affect the older workers to develop interventions to improve their health and

safety. . . . Few studies exist to guide clinicians in supporting ongoing employment among patients with CVD.”

Dickson et al., 2012, p. 7

42 CHAPTER 2 Introduction to Quantitative Research

Research Objectives, Questions, or Hypotheses Investigators formulate research objectives (or aims), questions, or hypotheses to bridge the gap

between the more abstractly stated research problem and purpose and the study design and plan

for data collection and analysis. Objectives, questions, and hypotheses are narrower in focus

than the purpose and often specify only one or two research variables. They also identify the

relationship between the variables and indicate the population to be studied. Some descriptive

studies include only a research purpose, whereas others include a purpose and objectives or

questions to direct the study. Some correlational studies include a purpose and specific questions

or hypotheses. Quasi-experimental and experimental studies need to include hypotheses to

Person: Individual-level

factors

Problem: Job-level factors

Health and quality of life

Self-care

• Knowledge • Experience • Skill • Compatibility with values

Environment: Work organization

Decision-making characteristics

FIG 2-2 Decision-making model of self-care and organization of work. (From Dickson, V. V., Howe, A., Deal, J., & McCarthy, M. M. [2012]. The relationship of work, self-care, and quality of life in a sample of older working adults with cardiovascular disease. Heart & Lung, 41[1], 7.)

Dickson and colleagues (2012) based their study framework on a theory of heart failure self-care (Riegel &

Dickson, 2008) and presented their framework as a map (Figure 2-2), described in the following excerpt:

“Self-care, conceptualized as a naturalistic decision-making process [see Figure 2-2], is situation- and

context-specific and influenced by the person’s knowledge about and experience with decision making in

the particular context, the person’s skill to act on the decision made, and the compatibility of the decision

and action with the person’s values.

According to the naturalistic decision-making framework of self-care in real-world settings such as

the workplace, people make decisions that are influenced by the interaction among the individual, the

problem, and the current setting or environment. According to this model, workers with CVD must make

decisions daily about engaging in self-care within the context of the workday. These decisions will be influ-

enced by job-level factors, such as job demands, job control, workplace support, and work organization

(e.g., workplace policies).” Dickson et al., 2012, pp. 6, 7

43CHAPTER 2 Introduction to Quantitative Research

direct the conduct of the studies and the interpretation of findings (Grove et al., 2013). Chapter 5

provides guidelines for critically appraising the objectives, questions, and hypotheses in research

reports.

Study Variables The research purpose and objectives, questions, or hypotheses identify the variables to be exam-

ined in a study. Variables are concepts at various levels of abstraction that are measured, manip-

ulated, or controlled in a study. More concrete concepts, such as temperature, weight, or blood

pressure, are referred to as variables in a study. More abstract concepts, such as creativity, empathy,

or social support, sometimes are referred to as research concepts.

Researchers operationalize the variables or concepts in a study by identifying conceptual and

operational definitions. A conceptual definition provides a variable or concept with theoretical

meaning (Grove et al., 2013), and it comes from a theorist’s definition of the concept or is devel-

oped through concept analysis. The conceptual definitions of variables provide a link from selected

concepts in the study framework to the study variables. Researchers develop an operational def-

inition so that the variable can be measured or manipulated in a study. The knowledge gained from

studying the variable will increase understanding of the theoretical concept from the study frame-

work that the variable represents (see Chapter 7 for a more detailed discussion of concepts and

frameworks). Chapter 5 provides a more extensive discussion of study variables.

Dickson and co-workers (2012) clearly identified the following study variables in their research

purpose and aims: job-level factors or characteristics, quality of life, self-care adherence behaviors,

and common illness characteristics of depression and physical functioning. Clear conceptual def-

initions were provided for the variables of self-care adherence behaviors and job-level factors or

characteristics but not for the other variables of quality of life and illness characteristics of depres-

sion and physical functioning. All study variables were operationally defined, with clearly identi-

fied measurement methods for the variables. The conceptual and operational definitions for

self-care adherence behaviors and job-level factor variables are provided as an example.

Dickson and associates (2012) developed the following two specific aims:

“1. To describe adherence to common self-care practices of older workers with CVD

2. To examine how job-level factors explain variation in self-care adherence behaviors and quality of

life, taking into account common illness characteristics (depression and physical functioning)” Dickson

et al., 2012, p. 7

DEFINITIONS OF STUDY VARIABLES

Self-Care Adherence Behaviors Conceptual Definition

“Self-care, conceptualized as a naturalistic decision-making process, is situation- and content-specific

and influenced by the person’s knowledge about and experience with decision making in the particular

context, the person’s skill to act on the decision made, and the compatibility of the decision and action with

the person’s values [see Figure 2-2] that determine the self-care adherence behaviors for older adults

with CVD.” Dickson et al., 2012, p. 6

Operational Definition “In this study, measurement of self-care focused on the adherence to commonly recommended

behaviors . . . and was assessed using the Specific Adherence Survey from the Medical Outcomes study.

44 CHAPTER 2 Introduction to Quantitative Research

Study Design Research design is a blueprint for the conduct of a study that maximizes control over factors that

could interfere with the study’s desired outcome. The type of design directs the selection of a pop-

ulation, procedures for sampling, methods of measurement, and plans for data collection and anal-

ysis. The choice of research design depends on what is known and not known about the research

problem, the researcher’s expertise, the purpose of the study, and the intent to generalize the

findings.

Sometimes the design of a study indicates that a pilot study was conducted. A pilot study is

often a smaller version of a proposed study, and researchers frequently conduct these to refine

the study sampling process, treatment, or measurement of variables (Hertzog, 2008). For example,

researchers might conduct pilot studies in a manner similar to the proposed study using similar

subjects, the same setting, the same treatment, the same measurement methods, and the same

data collection and analysis techniques to determine their quality. Chapter 8 presents a basis

for critically appraising designs in research reports.

Designs have been developed to meet unique research needs as they emerge; thus, a variety of

descriptive, correlational, quasi-experimental, and experimental designs have been generated over

time. In descriptive and correlational studies, no treatment is administered, so the purposes of

these study designs include improving the precision of measurement, describing what exists,

and clarifying relationships that provide a basis for quasi-experimental and experimental studies.

Quasi-experimental and experimental study designs usually involve treatment and control groups,

and focus on achieving high levels of control, as well as precision in measurement (see Table 2-1).

A study’s design usually is in the methodology section of a research report. Dickson and colleagues

(2012) conducted a descriptive correlational study with a typical descriptive design and a predic-

tive correlational design. The descriptive part of the design provided a basis for describing the

study variables of self-care adherence behaviors, job-level factors, quality of life, depression,

and physical functioning for older adults with CVD. The predictive correlation part of the design

focused on examining the relationships among the study variables and the use of job-level factors

to predict self-care adherence behaviors, which were then included with depression and physical

functioning to predict quality of life.

The specific Adherence Survey consists of eight CVD-pertinent questions that assess adherence to

medication, diet, exercise, symptom monitoring, and alcohol and cigarette use over the prior 4-week

period. . . . In addition, individuals who reported a history of chronic angina or history of myocardial infarction

also completed the Self-Care of Heart Disease Index (SCHDI), a new instrument based on the established

Self-Care of Heart Failure Index.” Dickson et al., 2012, p. 8

Job-Level Factors Conceptual Definition Job-level factors or characteristics influencing the self-care of workers with CVD include job demands, job

control, and workplace support.

Operational Definition “The Job Content Questionnaire (JCQ) was used to assess job-related factors of job demands, job control,

and workplace support. . . . The JCQ consists of 27 items that constitute five scales: job control, psychologic

demands, physical demands, support (supervisor and co-worker support), and job insecurity.” Dickson

et al., 2012, p. 8

45CHAPTER 2 Introduction to Quantitative Research

Population and Sample The population is all elements (individuals, objects, or substances) that meet certain criteria for

inclusion in a study (Kerlinger & Lee, 2000). A sample is a subset of the population selected for

a particular study, and the members of a sample are the subjects or participants. Sampling was

introduced earlier in this chapter, and Chapter 9 provides a background for critically appraising

populations, samples, and settings in research reports.

The following excerpt identifies the sampling method, sample size, population, setting,

sampling criteria, and sample characteristics for the study conducted by Dickson and associates

(2012). This study included a quality description of the sampling process and a power analysis

discussion, which is often conducted to determine an adequate sample size for a study (Grove

et al., 2013). The sample characteristics were presented in a table and in narrative in the article.

Measurement Methods Measurement is the process of “assigning numbers to objects (or events or situations) in accord

with some rule” (Kaplan, 1964, p. 177). A component of measurement is instrumentation, which

is the application of specific rules to the development of a measurement method or instrument

(Grove et al., 2013). An instrument is selected to measure a specific variable in a study. The

numerical data generated with an instrument may be at the nominal, ordinal, interval, or ratio

level of measurement. The level of measurement, with nominal being the lowest form of measure-

ment and ratio being the highest, determines the type of statistical analysis that can be performed

on the data. Chapter 10 introduces you to the concept of measurement, describes different types

of measurement methods, and provides direction to appraise measurement techniques in studies

critically.

Dickson and co-workers (2012) measured self-care adherence to commonly recommended

behaviors using the Specific Adherence Survey from the Medical Outcomes study and the SCHDI.

(These instruments were mentioned earlier in the operational definition of self-care.) The follow-

ing study excerpt identified the scales and questionnaires used to measure the other study variables.

The researchers provided quality descriptions of the measurement methods used in their study and

indicated that these methods were commonly used in other studies and found to be reliable (con-

sistent measurement) and valid (accurate in measuring a variable).

“a . . . convenience sample [sampling method] of 129 adults (>age 45) with CVD [sample size and population]

enrolled from outpatient settings associated with a large urban medical center [setting]. . . . Individuals were

eligible to participate if they met the following inclusion criteria: (1) diagnosis related to the cardiovascular

system (hypertension, coronary heart disease, e.g., myocardial infarction and angina, cardiac arrhythmia,

valve disease, heart failure; stroke, peripheral vascular disease, or hyperlipidemia; (2) age 45 years or older;

and (3) employed within the past year. Individuals were excluded from participating if they were unable or

unwilling to provide informed consent, were unable to read or write in English, or had been unemployed

for the prior year [inclusion and exclusion sampling criteria].

A sample of 129 adults with CVD (female 56%, African American 36.5%; mean age 59.2 � 8.83 years) participated in the study. Seventy-nine percent were actively employed at the time of the study (average

hours worked per week 29.29 � 19.07). Employment in a service job was the most common occupation reported. Hypertension was reported in 43% of the sample; 34% had coronary heart disease (prior myo-

cardial infarction, angina, or heart failure) [sample characteristics].” Dickson et al., 2012, pp. 7, 9

46 CHAPTER 2 Introduction to Quantitative Research

Data Collection Data collection is the precise, systematic gathering of information relevant to the research purpose

or the specific objectives, questions, or hypotheses of a study. To collect data, the researcher must

obtain permission from the setting or agency in which the study will be conducted. Researchers

must also obtain consent from all study participants to indicate their willingness to be in the study.

Frequently, the researcher asks the study participants to sign a consent form, which describes the

study, promises them confidentiality, and indicates that they can withdraw from the study at any

time. The research report should document permission from an agency to conduct a study and

consent of the study participants (see Chapter 4).

During data collection, investigators use a variety of techniques for measuring study variables,

such as observation, interview, questionnaires, scales, and biological measures. In an increasing

number of studies, nurses are measuring physiological and pathological variables using high-

technology equipment. Researchers collect and systematically record data on each subject, orga-

nizing the data in a way that facilitates computer entry (see Chapter 10 for more details on critically

appraising data collection in a study). Data collection is usually described in the methodology

section of a research report under the subheading of “Procedures.”

Data Analysis Data analysis reduces, organizes, and gives meaning to the data. Analysis techniques conducted in

quantitative research include descriptive and inferential analyses (see Chapter 11) and some

sophisticated, advanced analysis techniques. Investigators base their choice of analysis techniques

primarily on the research objectives, questions, or hypotheses, and level of measurement achieved

by the measurement methods. Often research reports indicate the analysis techniques that were

“Quality of life was measured in two ways. Health-related quality of life (HRQOL) was measured using the

MacNew Heart Disease Heart-Related Quality of Life questionnaire. This valid and reliable instrument has

been used extensively in CVD research to evaluate how quality of life is affected by one’s heart disease

and treatment. . . . A general measure of quality of life was also assessed using a single question—‘How

do you rate your quality of life?’—rated on a four-point Likert scale of 1¼poor to 4¼very good. . . . The Job Content Questionnaire (JCQ) was used to assess job-related factors of job demands, job

control, and workplace support. This instrument is widely used in organization of work research and has

demonstrated adequate reliability across many work groups. . . .

Depression was measured by the Patient Health Questionnaire (PHQ)-9, a brief measure that has

been used as a provisional diagnostic tool for major or minor depression in addition to depressive

symptoms. . . . Physical functioning was assessed by the Duke Activity Status Index (DAS), which measures

the individual’s ability to perform a range of specific daily activities and has been used in studies of CVD and

other chronic conditions.” Dickson et al., 2012, p. 8

Dickson and colleagues (2012) clearly covered their data collection process in the following excerpt regarding

procedures:

“After approval from the appropriate institutional review boards, participants were recruited from outpatient

programs that serve employed populations through the delivery of medical care, employee health, and occu-

pational health programs in a large urban population. Flyers promoting the study were available to individuals

who visited the participating settings. A research assistant trained in the study recruitment and enrollment

protocol was available during scheduled clinic hours to facilitate enrollment, obtain written informed

consent, and complete data collection. Individuals received a non-coercive incentive of $20 for survey

completion.” Dickson et al., 2012, pp. 7-8

47CHAPTER 2 Introduction to Quantitative Research

used in the study, and this content is covered prior to the study results. You can find the outcomes

of the data analysis process in the results section of the research report; this section is best orga-

nized by the research objectives, questions, or hypotheses of the study.

Dickson and associates (2012) clearly identified the analysis techniques used in their study in

the following excerpt. The “Results” section of their study described the study outcomes and clearly

presented the results in figure, tables, and narrative.

Dickson and colleagues also conducted regression analyses to predict self-care adherence behav-

iors and quality of life. Regression analysis is a common technique used in nursing studies for mak-

ing predictions. More details on regression analysis are presented in Chapter 11; the regression

results from this study are discussed in that chapter.

Discussion of Research Outcomes The results obtained from data analyses require interpretation to be meaningful. Interpretation of

research outcomes involves examining the results from data analysis, identifying study limita-

tions, exploring the significance of the findings, forming conclusions, generalizing the findings,

considering the implications for nursing, and suggesting further studies. The study outcomes

are usually presented in the discussion section of the research report. Limitations are restrictions

in a study methodology and/or framework that may decrease the credibility and generalizability

of the findings. A generalization is the extension of the conclusions made based on the research

findings from the sample studied to a larger population. The study conclusions provide a basis for

the implications of the findings for practice and identify areas for further research. Study outcomes

are discussed in detail toward the end of Chapter 11. Dickson and associates (2012) provided the

following quality discussion of their study outcomes:

Data Analysis “Standard descriptive statistics of central tendency and dispersion were used to describe the sample.

Relationships among physical functioning, depression, job-level factors of job demands (psychologic and

physical), job control, workplace support (supervisor and co-worker) and job insecurity, adherence, and

quality of life were analyzed using appropriate correlational methods. The student t-test and analysis of

variance compared differences in the groups (e.g., employment status, gender, and race) with respect to

adherence and quality of life. . . .”

Results “. . .There was significant correlation of the SCHDI self-care maintenance scale and the Specific Adherence

Survey (r¼.614, p<.001). . . . Older individuals had better self-care adherence practices. An independent sample t-test comparing the Specific Adherence Survey score by age category found a significant

difference. . . . Depression was associated with poorer adherence to treatment recommendations

(r ¼ �.313, p ¼ .001). Individuals with higher levels of physical functioning reported better adherence (r ¼ .281, p ¼ .002). . . .

Increased psychologic job demands were negatively associated with adherence (r ¼ �.31, p ¼ .002), but the relationship between physical job demands and adherence was not significant. . . . Better adherence was

reported by those with increased job control (r ¼ .244, p ¼ .016) and workplace support (coworker support r ¼ .267, p ¼ .002; supervisor support r ¼ .291, p ¼ .001).” Dickson et al., 2012, pp. 8-9

48 CHAPTER 2 Introduction to Quantitative Research

READING RESEARCH REPORTS

Understanding the steps of the research process and learning new terms related to those steps will

assist you in reading research reports. A research report summarizes the major elements of a study

and identifies the contributions of that study to nursing knowledge. Research reports are presented

at professional meetings and conferences and are published online and in print journals and books.

These reports often are difficult for nursing students and new graduates to read and to apply the

knowledge in practice. Maybeyouhave had difficultylocating researcharticles or understanding the

content of these articles. We would like to help you overcome some of these barriers and assist you in

understanding the research literature by (1) identifying sources that publish research reports, (2)

describing the content of a research report, and (3) providing tips for reading the research literature.

Discussion “To our knowledge, this is the first study to explore the complex relationship between job characteristics and

adherence among older workers with CVD. We found that although most individuals reported taking med-

ications, few consistently adhered to other self-care behaviors commonly recommended for patients with

CVD. . . . Our results suggest that increased job demands and low job control may be reasons for the dimin-

ished adherence to routinely recommended self-care behaviors that has been found in older workers with

CVD. . . . Our finding that depression and physical functioning are related to adherence among older workers

with CVD is also an important contribution. . . . In addition, employment status among chronically ill adults is

strongly linked to quality of life [study findings]. . . . To our knowledge, the relationship between adherence

and age is a unique finding that requires further investigation because the proportion of America’s workforce

aged more than 55 years is growing rapidly [suggestion for further research].”

Limitations “. . . The new SCHDI used to describe self-care maintenance and management had marginal reliability and

requires further psychometric validation. Few individuals in our sample reported symptoms, so we were

unable to explore the relationship among job-level factors to individual response to symptoms. This is an

important area for future research because others have found that lack of job flexibility, long work hours,

and fear of discrimination have been identified as reasons that individuals with acute coronary symptom delay

seeking treatment when experiencing chest pain symptoms during work hours.

. . . [We] used a convenience sample of working adults; therefore, we were unable to examine the influ-

ence of specific organizational policies and practices. . . . Further testing of the model [Figure 2-2] that

includes the interaction of the work organization and job-level factors on self-care and health is warranted.

Our sample included a range of CVD diagnosis with varying levels of self-care requirements and treat-

ment complexity. The sample size was not sufficient to examine differences across different diagnoses (e.g.,

hypertension compared with stroke). Furthermore CVD diagnosis was self-reported, which is a limitation [this

section covered limitations and suggestions for further research]. . . .”

Conclusions “The results of this exploratory study are an important step to address the 2009 American Heart Associa-

tion’s policy statement on worksite wellness program for CVD prevention [conclusion]. . . . Research to

develop and test interventions to foster worksite programs that facilitate self-care behaviors among older

workers with CVD is needed. Research efforts should include the objective measurement of adherence

and self-care [suggested further research]. Programs that target general self-care such as diet and exercise,

as well as more complex self-care (e.g., after myocardial infarction or those with heart failure), are indicated to

address the needs across the working population. Nurses with expertise in occupational health are well

suited to champion these efforts [implications for practice].” Dickson et al., 2012, p. 10-12

49CHAPTER 2 Introduction to Quantitative Research

Sources of Research Reports The most common sources for nursing research reports are professional journals. Research reports

are the major focus of several nursing research journals, identified in Table 2-3. Two journals in

particular, Applied Nursing Research and Clinical Nursing Research, focus on communicating

research findings to practicing nurses. These journals usually include less detail on the framework,

methodology, and statistical results of a study and more on discussion of the findings and impli-

cations for practice. The journal Worldviews on Evidence-Based Nursing focuses on innovative ideas

for using evidence to improve patient care globally.

Many of the nursing clinical specialty journals also place a high priority on publishing research

findings. Table 2-3 identifies some of the clinical journals in which research reports constitute a

major portion of the journal content. More than 100 nursing journals are published in the United

States, and most of them include research articles. The findings from many studies are now

communicated through the Internet as journals are placed online; selected websites include the

most current healthcare research. How to search for quality research sources is described in detail

in Chapter 6.

TABLE 2-3 RESEARCH AND CLINICAL JOURNALS PROVIDING IMPORTANT SOURCES OF RESEARCH REPORTS

RESEARCH JOURNALS CLINICAL JOURNALS

Advances in Nursing Science

Applied Nursing Research

Biological Research for Nursing

Clinical Nursing Research

International Journal of Nursing

Studies

Journal of Nursing Research

Journal of Nursing Scholarship

Nursing Research

Nursing Science Quarterly

Qualitative Health Research

Qualitative Nursing Research

Research in Nursing & Health

Scholarly Inquiry for Nursing Practice

World Views on Evidence-Based

Nursing

American Journal of Alzheimer’s Care & Related Disorders and

Research

Birth

Cardiovascular Nursing

Computers in Nursing

Heart & Lung

Issues in Comprehensive Pediatric Nursing

Issues in Mental Health Nursing

International Journal of Nursing Terminologies and Classifications

Journal of Child and Adolescent Psychiatric and Mental Health

Nursing

Journal of Continuing Education in Nursing

Journal of Holistic Nursing

Journal of National Black Nurses’ Association

Journal of Nursing Education

Journal of Pediatric Nursing: Nursing Care of Children and Families

Journal of Transcultural Nursing

Maternal-Child Nursing Journal

Public Health Nursing

Rehabilitation Nursing

The Diabetes Educator

50 CHAPTER 2 Introduction to Quantitative Research

Content of Research Reports At this point, you may be overwhelmed by the seeming complexity of a research report. You

will find it easier to read and comprehend these reports if you understand each of the component

parts. A research report often includes six parts: (1) abstract, (2) introduction, (3) methods,

(4) results, (5) discussion, and (6) references. These parts are described in this section and the

study by Twiss and co-workers (2009), which examined the effects of an exercise intervention

on the muscle strength and balance of breast cancer survivors with bone loss, is presented as

an example.

Abstract Section

The report usually begins with an abstract, which is a clear, concise summary of a study (Crosby,

1990; Grove et al., 2013). Abstracts range from 100 to 250 words and usually include the study

purpose, design, setting, sample size, major results, and conclusions. Researchers hope that their

abstracts will convey the findings from their study concisely and capture your attention so that you

will read the entire report. Usually, four major content sections of a research report follow the

abstract: introduction, methods, results, and discussion. Box 2-1 outlines the content covered

in each of these sections. It is also briefly discussed in the following sections.

BOX 2-1 MAJOR SECTIONS OF A RESEARCH REPORT

Introduction

Statement of the problem, with background and significance

Statement of the purpose

Brief literature review

Identification of the framework

Identification of the research objectives, questions, or hypotheses (if applicable)

Methods

Identification of the research design

Description of the treatment or intervention (if applicable)

Description of the sample and setting

Description of the methods of measurement (including reliability and validity)

Discussion of the data collection process

Results

Description of the data analysis procedures

Presentation of results in tables, figures, or narrative organized by the purpose(s) and/or objectives,

questions, or hypotheses

Discussion

Discussion of major findings

Identification of the limitations

Presentation of conclusions

Implications of the findings for nursing practice

Recommendations for further research

51CHAPTER 2 Introduction to Quantitative Research

Introduction Section

The introduction section of a research report identifies the nature and scope of the problem being

investigated and provides a case for the conduct of the study. You should be able to identify the

significance of conducting the study clearly to generate knowledge for nursing practice. Twiss and

colleagues’ (2009) study was significant because an estimated 182,460 women in the United States

are diagnosed with breast cancer each year, and these women are at risk for osteoporosis because of

their cancer therapies. An exercise intervention could be an effective way to increase their muscle

strength and balance and decrease falls. The purpose of this study was clearly stated in the abstract.

RESEARCH EXAMPLE

Abstract

Research Study Excerpt Twiss and colleagues (2009) developed the following clear, comprehensive abstract, which conveys the critical infor-

mation about their quasi-experimental study and includes the study’s clinical relevance. However, the abstract might

be considered a little long at 325 words.

“Purpose . . . (a) to determine if 110 postmenopausal breast cancer survivors (BCS) with bone loss who participated in

24 months of strength and weight training (ST) exercises had improved muscle strength and balance and had

fewer falls compared to BCS who did not exercise; and (b) to describe type and frequency of ST exercises;

adverse effects of exercises; and participants’ adherence to exercise at home, at fitness centers, and at

36-month follow-up.

Design Findings reported are from a federally funded multi-component intervention study of 223 postmenopausal

BCS with either osteopenia or osteoporosis who were randomly assigned to exercise (n¼110) or comparison (n¼113) groups.

Methods Time points for testing outcomes were baseline, 6, 12, and 24 months into the intervention. Muscle strength

was tested using Biodex Velocity Spectrum Evaluation and dynamic balance using Timed Backward Tandem

Walk. Adherence to exercises was measured using self-report of number of prescribed sessions attended

and participants’ reports of falls.

Findings Mean adherence over 24 months was 69.4%. Using generalized estimating equation (GEE) analyses, com-

pared to participants not exercising, participants who exercised for 24 months had significantly improved hip

flexion (p¼.011), hip extension (p¼.0006), knee flexion (p¼.0001), knee extension (p¼.0018), wrist flexion (p¼.031), and balance (p¼.010). Gains in muscle strength were 9.5% and 28.5% for hip flexion and exten- sion, 50.0% and 19.4% for wrist flexion and extension, and 21.1% and 11.6% for knee flexion and extension.

Balance improved by 39.4%. Women who exercised had fewer falls, but difference in number of falls

between the two groups was not significant.

Conclusions Many postmenopausal BCS with bone loss can adhere to a 24 month ST exercise intervention, and exercises

can result in meaningful gains in muscle strength and balance.

Clinical Relevance More studies are needed for examining relationships between muscle strength and balance in postmeno-

pausal BCSs with bone loss and their incidence of falls and fractures.” Twiss et al., 2009, p. 20

52 CHAPTER 2 Introduction to Quantitative Research

Depending on the type of research report, the literature review and framework may be separate

sections or part of the introduction. The literature review documents the current knowledge of the

problem investigated and includes the sources used to develop the study and interpret the findings.

For example, Twiss and co-workers (2009) summarized the literature in a background section that

included research in the areas of ST exercises, adherence to exercise, adverse effects of exercise,

muscle strength, balance, and falls. A research report also needs to include a framework, but only

about half of the published studies identify one. They (Twiss et al., 2009) did not identify a frame-

work for their study. The inclusion of a physiological framework that focused on the impact of

exercise on the physiological function of the musculoskeletal system would have strengthened this

study. The relationships in the framework provide a basis for the formulation of hypotheses to be

tested in quasi-experimental and experimental studies.

Investigators often end the introduction by identifying the objectives, questions, or hypotheses

that they used to direct the study. However, their study (Twiss et al.. 2009) lacked a framework, and

no hypotheses were developed to direct this quasi-experimental study.

Methods Section The methods section of a research report describes how the study was conducted and usually

includes the study design, treatment (if appropriate), sample, setting, measurement methods, and

data collection process. This section of the report needs to be presented in enough detail so that

the reader can critically appraise the adequacy of the study methods to produce reliable findings.

Twiss and co-workers (2009) provided extensive coverage of their study methodology. The

design was clearly identified as a multisite, randomized controlled trial (RCT). They also included

the subsection sample, which described the population, sampling method, sample criteria, sample

size, attrition, and reasons for withdrawing from the study. Institutional approval for the conduct

of this study and consent of the participants and their physicians were also discussed in this sub-

section. A subsection setting was included, which clearly indicated the sites where the study was

conducted.

ST exercises was another subsection and provided a detailed description of the exercise inter-

vention and how it was implemented in this study. A protocol for the intervention was also

included in a table in the article. Measures was another subsection of the study methodology that

detailed the quality of the measurement methods used to measure the dependent variables of mus-

cle strength, balance, falls, adherence to the exercise sessions, and any adverse effects from the exer-

cise. The measurements used in this study were identified previously in the study abstract. The

methods section concluded with a subsection of statistical analysis that detailed the analytical tech-

niques used to analyze the study data.

Results Section The results section presents the outcomes of the statistical tests used to analyze the study data and

significance of these outcomes. The research purpose or objectives, questions, and hypotheses for-

mulated for the study are used to organize this section. Researchers identify the statistical analyses

conducted to address the purpose or each objective, question, or hypothesis, and present the spe-

cific results obtained from the analyses in tables, figures, or narrative of the report (Grove et al.,

2013). Focusing more on the summary of the study results and their significance than on the sta-

tistical results can help reduce the confusion that may be caused by the numbers.

Twiss and colleagues (2009) had a findings section that might have been more clearly labeled as

“Results.” This section began with a description of the sample; sample characteristics were pre-

sented in a table. The study results were organized by the study variables of adverse effects of

53CHAPTER 2 Introduction to Quantitative Research

exercises, adherence to exercises, muscle strength and balance, and falls. As indicated in the

abstract, the study results were significant for all study variables except falls.

Discussion Section The discussion section ties together the other sections of the research report and gives them mean-

ing. This section includes the major findings, limitations of the study, conclusions drawn from the

findings, implications of the findings for nursing, and recommendations for further research.

Twiss and associates (2009) discussed their findings in detail and compared and contrasted

them with the findings of previous research studies. They also included a separate section in

the study, “Limitations,” which included the following: participants were not obtaining sufficient

vitamin D, stronger intervention fidelity was needed, self-report of adherence often results in an

overestimation of true levels of adherence, a lack of test-retest reliability for the investigator-

developed instruments used in the study, and the small number of minority women who com-

pleted the study were not representative of this Midwestern state.

Thediscussionsectionalsoincludedasubsection,“Conclusions,”thatpresentedtheimplications

for practice and identified the future studies needed. The conclusions drawn from a research project

can be useful in at least three different ways. First, you can implement the intervention or treatment

tested in a study with patients to improve theircare and promote a positive health outcome. Second,

reading research reports might change your view of a patient’s situation or provide greater insight

into the situation. Finally, studies heighten your awareness of the problems experienced by patients

and assist you in assessing and working toward solutions for these problems. Twiss and co-workers

(2009)alsoprovidedaclinicalresourcessection;thisincluded websiteswithresearchevidenceabout

osteoporosis, breast cancer, and BCS support that would be useful for practice.

References Section A references section that includes all sources cited in the research report follows the discussion

section. The reference list includes the studies, theories, and methodology resources that provided

a basis for the conduct of the study. These sources provide an opportunity to read about the

research problem in greater depth. We strongly encourage you to read the Twiss and

colleagues’ (2009) article to identify the sections of a research report and examine the content

in each of these sections. These researchers detailed a rigorously conducted quasi-experimental

study, provided findings that are supportive of previous research, and identified conclusions that

provide sound evidence to direct the care of patients who are BCSs with bone loss.

Tips for Reading Research Reports When you start reading research reports, you may be overwhelmed by the new terms and complex

information presented. We hope that you will not be discouraged but will see the challenge of

examining new knowledge generated through research. You probably will need to read the report

slowly two or three times. You can also use the glossary at the end of this book to review the def-

initions of unfamiliar terms. We recommend that you read the abstract first and then the discus-

sion section of the report. This approach will enable you to determine the relevance of the findings

to you personally and to your practice. Initially your focus should be on research reports that you

believe can provide relevant information for your practice.

Reading a research report requires the use of a variety of critical thinking skills, such as skim-

ming, comprehending, and analyzing, to facilitate an understanding of the study (Wilkinson,

2012). Skimming a research report involves quickly reviewing the source to gain a broad over-

view of the content. Try this approach. First, familiarize yourself with the title and check the

54 CHAPTER 2 Introduction to Quantitative Research

author’s name. Next, scan the abstract or introduction and discussion sections. Knowing the

findings of the study will provide you with a standard for evaluating the rest of the article. Then

read the major headings and perhaps one or two sentences under each heading. Finally, reexa-

mine the conclusions and implications for practice from the study. Skimming enables you to

make a preliminary judgment about the value of a source and whether to read the report

in depth.

Comprehending a research report requires that the entire study be read carefully. During this

reading, focus on understanding major concepts and the logical flow of ideas within the study. You

may wish to highlight information about the researchers, such as their education, current posi-

tions, and any funding they received for the study. As you read the study, steps of the research

process might also be highlighted. Record any notes in the margin so that you can easily identify

the problem, purpose, framework, major variables, study design, treatment, sample, measurement

methods, data collection process, analysis techniques, results, and study outcomes. Also record any

creative ideas or questions you have in the margin of the report.

We encourage you to highlight the parts of the article that you do not understand and ask your

instructor or other nurse researchers for clarification. Your greatest difficulty in reading the

research report probably will be in understanding the statistical analyses. Information in

Chapter 11 should help you understand the analyses included in studies. Basically, you must iden-

tify the particular statistics used, results from each statistical analysis, and meaning of the results.

Statistical analyses describe variables, examine relationships among variables, or determine differ-

ences among groups. The study purpose or specific objectives, questions, or hypotheses indicate

whether the focus is on description, relationships, or differences. Therefore you need to link each

analysis technique to its results and then to the study purpose or objectives, questions, or hypoth-

eses presented in the study.

The final reading skill, analyzing a research report, involves determining the value of the

report’s content. Break the content of the report into parts, and examine the parts in depth for

accuracy, completeness, uniqueness of information, and organization. Note whether the steps

of the research process build logically on each other or whether steps are missing or incomplete.

Examine the discussion section of the report to determine whether the researchers have provided a

critical argument for using the study findings in practice. Using the skills of skimming, compre-

hending, and analyzing while reading research reports will increase your comfort with studies,

allow you to become an informed consumer of research, and expand your knowledge for making

changes in practice. These skills for reading research reports are essential for conducting a com-

prehensive critical appraisal of a study. Chapter 12 focuses on the guidelines for critically apprais-

ing quantitative and qualitative studies.

PRACTICE READING QUASI-EXPERIMENTAL AND EXPERIMENTAL STUDIES

Knowing the sections of the research report—Introduction, Methods, Results, and Discussion

(see Box 2-1)—provides a basis for reading research reports of quantitative studies. You can

apply the critical thinking skills of skimming, comprehending, and analysis to your reading

of the sample quasi-experimental and experimental studies provided here. Being able to read

research reports and identify the steps of the research process should enable you to conduct

an initial critical appraisal of a report. Throughout this text, you’ll find boxes, entitled

“Critical Appraisal Guidelines,” which provide questions you will want to consider in your

critical appraisal of various research elements or steps. This chapter concludes with initial critical

appraisals of a quasi-experimental study and an experimental study using the guidelines

provided.

55CHAPTER 2 Introduction to Quantitative Research

Quasi-Experimental Study The purpose of quasi-experimental research is to examine cause and effect relationships among

selected independent and dependent variables. Researchers conduct quasi-experimental studies

in nursing to determine the effects of nursing interventions or treatments (independent variables)

on patient outcomes (dependent variables; Shadish et al., 2002). Artinian and associates (2007)

conducted a quasi-experimental study to determine the effects of nurse-managed telemonitoring

(TM) on the blood pressure (BP) of African Americans. The steps for this study are illustrated with

excerpts from the research report.

? INITIAL CRITICAL APPRAISAL GUIDELINES Quantitative Research

The following questions are important in conducting an initial critical appraisal of a quantitative research report:

1. Whattypeofquantitativestudywasconducted—descriptive,correlational,quasi-experimental,orexperimental?

2. Can you identify the following sections in the research report—Introduction, Methods, Results, and

Discussion—as identified in Box 2-1?

3. Werethe stepsofthestudyclearlyidentified?Figure2-1 identifiesthestepsofthequantitativeresearchprocess.

4. Were any of the steps of the research process missing?

RESEARCH EXAMPLE

Steps of the Research Process in a Quasi-Experimental Study

Research Study Excerpt

1. Introduction

Research Problem

“Nearly one in three, or approximately 65 million adults in the United States have hypertension, defined as (a)

having systolic blood pressure (SBP) of 140 mmHg or higher or diastolic blood pressure (DBP) of at least

90 mm Hg or higher, (b) taking antihypertensive medication, or (c) being told at least twice by a physician

or other health professional about having high blood pressure (BP) (American Heart Association [AHA],

2005; AHA Statistics Committee and Stroke Statistics Subcommittee [AHASC], 2006; Fields et al., 2004).

. . . Estimated direct and indirect costs associated with hypertension total $63.5 billion (AHA, 2005). . . .

The crisis of high BP (HBP) is particularly apparent among African Americans; their prevalence of HBP is

among the highest in the world. . . . Unless healthcare professionals can improve care for individuals with

hypertension, approximately two thirds of the population will continue to have uncontrolled BP and face other

major health risks (Chobanian et al., 2003). . . . There is a need to test alternative treatment strategies.”

Artinian et al., 2007, pp. 312-313

Research Purpose

“The purpose of this randomized controlled trial with urban African Americans was to compare usual care (UC)

only with BP telemonitoring (TM) plus UC to determine which leads to greater reduction in BP from baseline over

12 months of follow-up, with assessments at 3, 6, and 12 months postbaseline.” Artinian et al., 2007, p. 313

Literature Review

The literature review for this study included relevant, current studies that summarized what is known about the

impact of TM on BP. The sources were current and ranged in publication dates from 1998 to 2005, with most

of the studies published in the last 5 years. The study was accepted for publication on May 31, 2007 and published

in the September/October 2007 issue of Nursing Research. Artinian and associates (2007, p. 314) summarized the

current knowledge about the effect of TM on BP by stating that,

56 CHAPTER 2 Introduction to Quantitative Research

“Although promising, the effects of TM on BP have been tested in small, sometimes nonrandomized, sam-

ples, with one study suggesting that patients may not always adhere to measuring their BP at home. The

influence of TM on BP control warrants further study.”

Framework

Artinian and co-workers (2007) developed a model that identified the theoretical basis for their study. The model is

presented in Figure 1 of this example (Figure 2-3) and indicates that

“Nurse-managed TM is an innovative strategy that may offer hope to hypertensive African Americans who

have difficulty accessing care for frequent BP checks. . . . In other words, TM may lead to a reduction in oppor-

tunity costs or barriers for obtaining follow-up care by minimizing the contextual risk factors that interfere with

frequent health care visits. . . . Combined with information about how to control hypertension, TM may both

help individuals gain conscious control over their HBP and contribute to feelings of confidence for carrying out

hypertension self-care actions. . . . Home TM appeared to contribute to individuals’ increased personal control

and self-responsibility for managing their BP, which ultimately led to improved BP control.” Artinian et al.,

2004; Artinian, Washington, & Templin, 2001

The framework for this study was based on tentative theory that was developed from the findings of previous

research by Artinian and colleagues (2001, 2004) and other investigators. This framework provides a basis for inter-

preting the study findings and giving them meaning. Continued

Blood Pressure (BP) Self Monitoring

Blood Pressure Telemonitoring

• Moves hypertension from state of silence to salience. • May help individual:

• connect symptoms of high BP to actual BP level; • see effects of lapses from medical regimen on BP; • see effects of stress or worry on BP level; • gain conscious control over their high BP; • gain feelings of confidence that they are capable of carrying out hypertension self-care actions; • gain sense of increased personal control, self-efficacy or self-responsibility for managing their BP.

Transmission of Blood Pressure Readings Over Existing Telephone Lines Using a Toll Free Number

• Facilitates access to health care for hypertension without the need for clinic or office visits.

• Reduces opportunity costs or barriers for obtaining hypertension follow-up care.

• Minimizes contextual risk factors that interfere with frequent healthcare visits.

• Provides a greater number of BP readings than can be provided by infrequent clinic visits; healthcare providers have more data upon which to base treatment decisions to achieve better BP control.

FIG 2-3 Theoretical basis for the effects of telemonitoring on blood pressure. (From Artinian, N. T., Flack, J. M., Nordstrom, C. K., Hockman, E. M., Washington, O. G. M., Jen, K. C., & Fathy, M. [2007]. Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans. Nursing Research, 56(5), 313.)

57CHAPTER 2 Introduction to Quantitative Research

RESEARCH EXAMPLE—cont’d

Hypothesis Testing

“H1: Individuals who participate in UC plus nurse-managed TM will have a greater reduction in BP from base-

line at 3-, 6-, and 12-month follow-up than would individuals who receive UC only.” Artinian et al., 2007, p. 317

Variables

The independent variable was a TM program and the dependent variables were systolic and diastolic BP (SBP and

DBP). Only the TM program and SBP are defined with conceptual and operational definitions. The conceptual

definitions are derived from the study framework and the operational definitions are often found in the methods

section, under measurement methods and intervention headings.

Independent Variable: Telemonitoring Program Conceptual Definition TM program is an innovative strategy that may offer hope to hypertensive African Americans to reduce their oppor-

tunity costs and barriers for obtaining follow-up care for BP management (Artinian et al., 2007).

Operational Definition TM “refers to individuals self-monitoring their BP at home, then transmitting the BP readings over existing tele-

phone lines using a toll-free number” (Artinian et al., 2007, p. 313). The readings were reviewed by the care pro-

viders, with immediate feedback provided to the patients about their treatment plan.

Dependent Variable: Systolic Blood Pressure Conceptual Definition SBP is an indication of the patient’s blood pressure control and ultimately the management of his or her

hypertension.

Operational Definition The outcome of SBP was measured with an electronic BP monitor (Omron HEM-737 Intellisense, Omron Health

Care, Bannockburn, IL; Artinian et al., 2007). The SBP was the first number recorded on the screen of the Omron BP

equipment.

2. Methods

Design

“A randomized, two-group, experimental, longitudinal design was used. The treatment group received nurse-

managed TM and the control group received enhanced UC. Data were collected at baseline and 3-, 6-, and 12-

month follow-ups.” Artinian et al., 2007, p. 314

Sample

“African Americans with hypertension [population] were recruited through free BP screenings offered at

community centers, thrift stores, drugstores, and grocery stores located on the east side of Detroit” [natural

settings]. Artinian et al., 2007, p. 315

The sampling criteria for including and excluding subjects from the study were detailed and provided a means of

identifying patients with hypertension. The sample size was 387 (194 in the TM group and 193 in the usual care

[UC] group), with a 13% attrition or loss of subjects over the 12-month study. The subjects’ recruitment and par-

ticipation in the study are detailed in a figure in the article (see Artinian et al., 2007, p. 316).

Intervention Artinian and associates (2007) detailed the nurse-managed TM intervention in their research article (pp. 315-316).

LifeLink Monitoring (Bearsville, NY) was used to provide the TM services for this study. The researchers also

described the enhanced UC that was received by the experimental and control groups.

58 CHAPTER 2 Introduction to Quantitative Research

Outcome Measurement The BP was measured with the electronic Omron BP monitor.

“. . . [A]fter a 5-minute rest period, at least two BPs were measured, and the average of all was used for ana-

lyses. Participants wore unrestrictive clothing and sat next to the interviewer’s table, their feet on the floor;

their back supported; and their arm abducted, slightly flexed, and supported at heart level by the smooth, firm

surface of a table.” Artinian et al., 2007, pp. 316-317

Data Collection “Most of the data were collected during 2-hour structured face-to-face interviews and brief physical exams,

which were conducted by trained interviewers in a private room at one of the project-affiliated neighborhood

community centers. Mailed postcards provided interview appointment reminders 1 week before the sched-

uled interview; telephone call reminders were made the evening before the interview. . . . Participants were

compensated $25.00 after the completion of each interview.” Artinian et al., 2007, p. 316

The study was approved by the Wayne State University Human Investigation Committee and all participants

signed consent forms indicating their willingness to be subjects in the study.

3. Results

“The hypothesis was supported partially by the data. Overall, the TM intervention group had a greater

reduction in SBP (13.0 mm Hg) than the UC group did (7.5 mm Hg; t ¼ �2.09, p¼.04) from baseline to the 12-month follow-up. Although the TM intervention group had a greater reduction in the DBP

(6.3 mm Hg) compared with the UC group (4.1 mm Hg), the differences were not statistically significant

(t ¼ �1.56, p¼.12).” Artinian et al., 2007, pp. 317-318

4. Discussion

“The nurse-managed TM group experienced both clinically and statistically significant reductions in SBP

(13.0 mm Hg) and clinically significant reductions in DBP (6.3 mm Hg) over a 12-month monitoring period

[study conclusions]. . . . The BP reductions achieved here are important results, which, if maintained over

time, could improve care and outcomes significantly for urban African Americans with hypertension. . . . This

may mean that an individual could avoid starting a drug regimen or may achieve BP control using a one-drug

regimen rather than a two-drug regimen and thus be at risk for fewer medication side effects [implications of

the findings for nursing practice]. . . . Future research needs to determine if this intervention effect maintained

over time leads to reducing the number of complications associated with uncontrolled BP and if it leads to

reducing the number of drugs necessary to achieve BP control.” Artinian et al., 2007, pp. 320-321

Initial Critical Appraisal Quasi-Experimental Study Artinian and colleagues (2007) presented a clear, concise, and comprehensive report of their quasi-experimental

study of the effect of TM on BP in urban African Americans. These researchers also clearly organized their research

article using the four major sections— Introduction, Methods, Results, and Discussion. Each section clearly detailed

the steps of the quantitative research process and no steps of the research process were omitted.

The findings from this applied study do have implications for practice because this nurse-managed TM interven-

tion significantly affected BP in a population with a high incidence of hypertension. Based on Artinian and col-

leagues’ (2001, 2007, 2004) research and the research of others that documented the importance of home BP

monitoring, a scientific statement from the American Heart Association, American Society of Hypertension,

and Preventive Cardiovascular Nurses Association recommended the use of and reimbursement for home BP mon-

itoring (Pickering, et al., 2008). Artinian was a member of the group making this recommendation about home BP

monitoring. For more information about the home BP monitoring recommendation, you can view the American

Heart Association (2011) website at http://my.americanheart.org/professional/General/Call-to-Action-on-Use-

and-Reimbursement-for-Home-Blood-Pressure-Monitoring_UCM_423866_Article.jsp.

59CHAPTER 2 Introduction to Quantitative Research

Experimental Study The purpose of experimental research is to examine cause and effect relationships between inde-

pendent and dependent variables under highly controlled conditions. The planning and imple-

mentation of experimental studies are highly controlled by the researcher, and often these

studies are conducted in a laboratory setting on animals or objects. Few nursing studies are purely

experimental. Sharma and co-workers (2010) conducted an experimental study of the effects of

aerobic exercise on analgesia and neurotropin-3 synthesis in an animal model of chronic wide-

spread pain. This study was introduced earlier in the discussion of basic research. We encourage

you to read this study, identify the sections of the research report (see Box 2-1), determine the steps

of the quantitative research process, and then compare your findings with those presented in this

section.

RESEARCH EXAMPLE

Steps of the Research Process in an Experimental Study

Research Study Excerpt

1. Introduction

Research Problem

“Present literature and clinical practice provide strong support for the use of aerobic exercise in reducing pain

and improving function for individuals with chronic musculoskeletal pain syndromes. However, the molecular

basis for positive actions of exercise remains poorly understood. Recent studies suggest that neurotropin-3

(NT-3) may act in an analgesic fashion in various pain states. . .

Chronic widespread pain is complex and poorly understood and affects about 12% of the adult popu-

lation in developed countries. Many laboratory animal models of pain have been produced to mimic human

painful conditions. The acid model used in the present study is a noninflammatory muscle pain model and is

considered to mirror some aspects of human fibromyalgia and other related syndromes that display referred

hypersensitivity to mechanical stimuli. . . . To date, no animal studies have evaluated the effect of exercise on

muscular hypersensitivity.” Sharma et al., 2010, pp. 714-715

Research Purpose

“The purpose of the present study was to examine the effects of moderate-intensity aerobic exercise on

pain-like behavior and NT-3 in an animal model of widespread pain.” Sharma et al., 2010, p. 714

Review of Literature

The research report of Sharma and colleagues (2010) was received on May 25, 2009, accepted for publi-

cation January 17, 2010, and published in 2010 in the journal of Physical Therapy (see the References for a

complete citation of this study). The review of literature in this study is current because the sources cited in

the study were published from 1987 through 2007, and most of the sources were published in the last 5 years

(2002-2007). The literature review included a synthesis of relevant studies, as indicated in the following

study excerpt.

“In recent years, evidence has emerged concerning the role of NT-3 as a pain modulator for thermal, mechan-

ical, and inflammatory hyperalgesia. Previous studies from our laboratory revealed that increased levels of

NT-3 (either genetically overexpressed or delivered intramuscularly) abolished mechanical hypersensitivity

that developed in response to intramuscular acid injections. If exercise increases NT-3 synthesis and NT-3

reduces cutaneous and thermal hyperalgesia, the next logical step is to test whether exercise-induced anal-

gesia can be achieved in a muscular pain model.” Sharma et al., 2010, p. 715

60 CHAPTER 2 Introduction to Quantitative Research

Framework

Sharma and associates (2010) did not clearly identify a framework for their study, but the study seemed to be based

on the physiological effects of exercise on NT-3 and deep tissue hyperalgesia in an animal model of pain. The focus

was on providing a possible molecular basis for exercise training in reducing muscular pain. A clearly stated frame-

work identifies the theoretical relationships or propositions that guide the development of study hypotheses for

quasi-experimental and experimental studies. No hypotheses were identified to direct the conduct of this study.

The study framework is also important for the interpretation of research findings and making them meaningful

to nursing practice.

Variables

The independent or treatment variable was exercise training, and the dependent or outcome variables

included cutaneous and deep tissue hyperalgesia, NT-3 synthesis, and NT-3 protein levels. The intervention

exercise training and the outcome variables of NT-3 synthesis and NT-3 protein levels are conceptually

and operationally defined as examples. The complete research report provides much more detail on the

intervention implemented, measurement of the dependent variables of cutaneous and deep tissue hyperalge-

sia with behavioral testing, and measurement of NT-3 synthesis and NT-3 protein levels using biochemical

assays.

Independent Variable: Exercise Training Conceptual Definition The independent variable was not clearly conceptually defined in the study but might be defined as aerobic exercise

implemented to determine the cellular effects on widespread muscle pain in an animal model.

Operational Definition “Two six-lane, motorized treadmills were used for exercise training. The exercise training intervention was

implemented 5 days per week for 3 weeks” (Sharma et al., 2010, p. 716).

Dependent Variables: NT-3 Synthesis and NT-3 Protein Levels Conceptual Definition These dependent variables were not clearly defined conceptually but might be defined as biochemical assays that

indicate the cellular response of skeletal muscles to exercise in an animal model.

Operational Definitions “Levels of NT-3 messenger RNA (mRNA) and protein in skeletal muscles were measured using standard

measures of quantitative real-time polymerase chain reaction (PCR) and enzyme-linked immunosorbent

assay (ELISA), respectively.” Sharma et al, 2010, p. 717

2. Methods

Sharma and co-workers (2010) clearly described the ethical approval of their study, selection of the mice for the

study, and laboratory setting for conducting the study.

“All experiments were approved by the Institutional Animal Care and Use Committee of the University

of Kansas Medical Center and adhered to the university’s animal care guidelines. Forty CF-1 female

mice (weight¼25 g) were used to examine the effects of moderately intense exercise on primary (muscular) and secondary (cutaneous) hyperalgesia and NT-3 synthesis. Because women develop

widespread pain syndromes at a greater rate than age-matched men, hyperalgesia was induced in female

mice. The mice were exposed to 12-hour light-dark cycle and had access to food and water ad libitum.

The mice received two 20-ml injections of either acidic saline . . . or normal saline . . . 2 days apart into the right gastrocnemius muscle to induce chronic widespread hyperalgesia or pain-like behavior.”

Sharma et al., 2010, p. 715 Continued

61CHAPTER 2 Introduction to Quantitative Research

RESEARCH EXAMPLE—cont’d

Experimental Design

Initially, the mice were randomly assigned to the acidic saline injection (experimental) group or the normal saline

injection (placebo) group. Five days after inducing hyperalgesia with acidic saline injections into the right limb, the

animals were further assigned to an exercise or no-exercise group, as follows: experimental with exercise (n¼10), experimental without exercise group (n¼10), placebo with exercise group (n¼10), and placebo without exercise group (n¼10). Sharma and colleagues (2010) included a strong, four-group experimental design to control the effects of the injection (placebo group receiving saline injection versus experimental group receiving acidic saline),

as well as the effects of the exercise training (no exercise versus exercise training groups). The dependent variables

were measured preinjection, postinjection, and 2 weeks postinjection to determine the changes following the injec-

tions and exercise training.

Measurements

Sharma and associates (2010) provided detailed descriptions of the measurement of the dependent variables

cutaneous and deep tissue hyperalgesia with behavior testing. The NT-3 sensitivity and NT-3 protein levels were

measured with biochemical assays that were previously identified in the operational definitions of the variables.

3. Results

“Moderate-intensity aerobic exercise reduced cutaneous and deep tissue hyperalgesia induced by acidic

saline and stimulated NT-3 synthesis in skeletal muscle. The increase in NT-3 was more pronounced at

the protein level compared with the messenger ribonucleic acid (mRNA) expression. In addition, the increase

in NT-3 protein was significant in the gastrocnemius muscle but not in the soleus muscle, suggesting that

exercise can preferentially target NT-3 synthesis in specific muscle types.” Sharma et al., 2010, p. 714

4. Discussion

Sharma and co-workers (2010) discussed their research findings and linked them to previous research. The

researchers stressed that the results are limited to animal models and cannot be generalized to humans experiencing

chronic pain. Thus further human studies were recommended to determine the intensity of exercise needed to

decrease pain symptoms and improve physical functioning in individuals with chronic pain. The researchers closed

with the following conclusions and suggestions for further research.

“We have demonstrated that moderate-intensity exercise training did not cure but significantly reduced cuta-

neous and deep tissue mechanical hypersensitivity induced by acidic saline injections. This finding is consis-

tent with the findings of human studies, as exercise does not reverse the painful condition but rather

decreases pain and improves function. The data also demonstrate an increase in activity-dependent NT-3

levels in selected peripheral tissues. Based on emerging views about the analgesic properties of NT-3, it

is plausible to suggest that the decrease in mechanical hypersensitivity following exercise may be due in part,

to elevated levels of NT-3 protein. However, the mechanism by which NT-3 modulates mechanoreceptors is

still unknown and remains to be investigated.” Sharma et al., 2010, p. 724

Initial Critical Appraisal Experimental Study Sharma and colleagues (2010) presented a complex, comprehensive report of their experimental study of the effects

of aerobic exercise on analgesia and NT-3 synthesis and protein levels in female mice. They also clearly organized

their article using the four major sections—Introduction, Methods, Results, and Discussion. Each section clearly

detailed the specific steps of the quantitative research process. This experimental study provides basic knowledge

about the biological processes of mice exposed to chronic pain and provides a basis for applied human research to

examine the effects of aerobic exercise on chronic widespread pain, such as the pain experienced by patients with

fibromyalgia. The study would have been strengthened by including a framework and hypothesis to direct its imple-

mentation and discussion of findings.

62 CHAPTER 2 Introduction to Quantitative Research

K E Y C O N C E P T S

• Quantitative research is the traditional research approach in nursing; it includes descriptive,

correlational, quasi-experimental, and experimental types of research.

• Basic, or pure, research is a scientific investigation that involves the pursuit of knowledge for

knowledge’s sake, or for the pleasure of learning and finding truth.

• Applied, or practical, research is a scientific investigation conducted to generate knowledge that

will directly influence or improve clinical practice.

• Conducting quantitative research requires rigor and control.

• A comparison of the problem-solving process, nursing process, and research process shows the

similarities and differences in these processes and provides a basis for understanding the

research process.

• The quantitative research process involves conceptualizing a research project, planning and

implementing that project, and communicating the findings. The steps of the quantitative

research process are briefly introduced in this chapter.

• The research problem is an area of concern in which there is a gap in the knowledge needed for

nursing practice. The research purpose is generated from the problem and identifies the specific

goal or focus of the study.

• The review of relevant literature is conducted to generate a picture of what is known and unknown

about a particular topic and provides a rationale for why the study needs to be conducted.

• The study framework is the theoretical basis for a study that guides the development of the

study and enables the researcher to link the findings to nursing’s body of knowledge.

• Research objectives, questions, and/or hypotheses are formulated to bridge the gap between the

more abstractly stated research problem and purpose and the study design and plan for data

collection and analysis.

• Study variables are concepts at various levels of abstraction that are measured, manipulated, or

controlled in a study.

• Research design is a blueprint for conducting a study that maximizes control over factors that

could interfere with the study’s desired outcomes.

• The population is all the elements that meet certain criteria for inclusion in a study. A sample is

a subset of the population that is selected for a particular study; the members of a sample are the

subjects or study participants.

• Measurement is the process of assigning numerical values to objects, events, or situations in

accord with some rule. Methods of measurement are identified to measure each of the variables

in a study.

• The data collection process involves the precise and systematic gathering of information rele-

vant to the research purpose or the objectives, questions, or hypotheses of a study.

• Data analyses are conducted to reduce, organize, and give meaning to the data and address the

research purpose and/or objectives, questions, or hypotheses.

• Research outcomes include the findings, limitations, generalization of findings, conclusions,

implications for nursing, and suggestions for further research.

• The content of a research report includes six parts—abstract, introduction, methods, results,

discussion, and references.

• Reading research reports involves skimming, comprehending, and analyzing the report.

• The guidelines for conducting an initial critical appraisal of a quantitative study are provided.

• Examples of initial critical appraisals are provided for a quasi-experimental study and an

experimental study.

63CHAPTER 2 Introduction to Quantitative Research

REFERENCES

American Heart Association, (2005). Heart disease and

stroke statistics—2005 update. Dallas, TX: Author.

American Heart Association (AHA). (2011). Call to action

on use and reimbursement for home blood pressure

monitoring. Retrieved July 1, 2013 from, http://my.

americanheart.org/professional/General/Call-to-

Action-on-Use-and-Reimbursement-for-Home-Blood-

Pressure-Monitoring_UCM_423866_Article.jsp.

American Heart Association Statistics Committee and

Stroke Statistics Subcommittee. (AHASC). (2006).

Heart disease and stroke statistics—2006 update.

Circulation, 113(6), e85–e152.

Artinian, N. T., Flack, J. M., Nordstrom, C. K.,

Hockman, E. M., Washington, O. G. M., Jen, K. C.,

et al. (2007). Effects of nurse-managed telemonitoring

on blood pressure at 12-month follow-up among

urban African Americans. Nursing Research, 56(5),

312–322.

Artinian, N., Washington, O., Klymko, K., Marbury, C.,

Miller, W., & Powell, J. (2004). What you need to know

about home blood pressure telemonitoring, but may

not know to ask. Home Healthcare Nurse, 22(10),

680–686.

Artinian, N., Washington, O., & Templin, T. (2001). Effects

of home telemonitoring and community-based

monitoring on blood pressure control in urban

African Americans: A pilot study. Heart & Lung, 30(3),

191–199.

Bodenheimer, T., Lorig, K., Holman, H., & Grumbach, K.

(2002). Patient self-management of chronic disease in

primary care. Journal of the American Medical

Association, 288(19), 2469–2475.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Bureau of Labor Statistics. (2008). Spotlight on statistics:

Older workers. Retrieved September 28, 2008 from,

http://www.bls.gov.

Campbell, D. T., & Stanley, J. C. (1963). Experimental and

quasi-experimental designs for research. Chicago: Rand

McNally.

Chinn, P. L., & Kramer, M. K. (2011). Integrated theory and

knowledge development in nursing (8th ed.). St. Louis:

Elsevier Mosby.

Chobanian, A., Bakris, G., Black, H., Cushman, W.,

Green, L., Izzo, J., Jr., et al. (2003). Seventh report of the

Joint National Committee on Prevention, Detection,

Evaluation, and Treatment of High Blood Pressure.

Hypertension, 42(6), 1206–1252.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh: Churchill

Livingstone Elsevier.

Crosby, L. J. (1990). The abstract: An important first

impression. Journal of Neuroscience Nursing, 22(3),

192–194.

Dickson, V. V., Howe, A., Deal, J., & McCarthy, M. M.

(2012). The relationship of work, self-care, and quality

of life in a sample of older working adults with

cardiovascular disease. Heart & Lung, 41(1), 5–14.

Doran, D. M. (2011). Nursing outcomes: The state of the

science (2nd ed.). Canada: Jones & Bartlett Learning.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia: F. A.

Davis.

Fields, L., Burt, V., Cutler, J., Hughers, J., Roccella, E., &

Sorlie, P. (2004). The burden of adult hypertension in

the United States 1999–2000: A rising tide.

Hypertension, 44(4), 398–404.

Fisher, R. A. Sir, (1935). The designs of experiments. New

York: Hafner.

Grove, S. K. (2007). Statistics for health care research: A

practical workbook. St. Louis: Saunders Elsevier.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis: Saunders.

Hertzog, M. A. (2008). Considerations in determining

sample size for pilot studies. Research in Nursing &

Health, 31(2), 180–191.

Kaplan, A. (1964). The conduct of inquiry: Methodology for

behavioral science. San Francisco: Chandler.

Kerlinger, F. N., & Lee, H. B. (2000). Foundations of

behavioral research (4th ed.). Fort Worth, TX:

Harcourt.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-

based practice in nursing and health care: A guide to best

practice (2nd ed.). Philadelphia: Lippincott, Williams &

Wilkins.

Miller, D. C., & Salkind, N. J. (2002). Handbook of research

design and social measurement (5th ed.). Newbury Park,

CA: Sage.

Morrison, D. M., Hoppe, M. J., Gillmore, M. R., Kluver, C.,

Higa, D., & Wells, E. A. (2009). Replicating an

intervention: The tension between fidelity and

adaptation. AIDS Education and Prevention, 21(2),

128–140.

National Human Genome Research Institute, An overview

of the division of intramural research, (2013) Retrieved

July 1, 2013 from, http://www.genome.gov/10001634.

64 CHAPTER 2 Introduction to Quantitative Research

National Institute of Occupational Safety and Health

(NIOSH), (2008). Work organization and stress-related

disorders. Retrieved July 1, 2013 from, http://www.cdc.

gov/niosh/programs/workorg/emerging.html.

Pickering, T. G., Miller, N. H., Ogedegbe, G., Krakoff, L. R.,

Artinian,N.T.,&Goff,D.(2008).Calltoactiononuseand

reimbursement for home blood pressure monitoring: A

joint scientific statement from the American Heart

Association, American Society of Hypertension, and

Preventive Cardiovascular Nurses Association. Journal of

Cardiovascular Nursing, 23(4), 299–323.

Pinto, M. D., Hickman, R. L., Clochesy, J., & Buchner, M.

(2013). Avatar-based depression self-management

technology: Promising approach to improve depressive

symptoms among young adults. Applied Nursing

Research, 26(1), 45–48.

Porter, T. M. (2004). Karl Pearson: The scientific life in a

statistical age. Oxfordshire, United Kingdom: Prince-

ton University Press.

Quality and Safety Education for Nurses (QSEN).

Pre-licensure knowledge, skills, and attitudes (KSAs).

(2013) Retrieved July 1, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas/.

Riegel, B., & Dickson, V. A. (2008). A situation-specific

theory of heart failure self-care. Journal of

Cardiovascular Nursing, 23(3), 190–196.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002).

Experimental and quasi-experimental designs

for generalized causal inference. Chicago:

Rand McNally.

Sharma, N. K., Ryals, J. M., Gajewski, B. J., & Wright, D. E.

(2010). Aerobic exercise alters analgesia and neurotropin-

3 synthesis in an animal model of chronic widespread

pain. Physical Therapy, 90(5), 714–725.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Twiss, J. J., Waltman, N. L., Berg, K., Ott, C. D., Gross, G. J.,

& Lindsey, A. M. (2009). An exercise intervention for

breast cancer survivors with bone loss. Journal of

Nursing Scholarship, 41(1), 20–27.

Weijman, I., Ros, W., Rutten, G., Schaufeli, W.,

Schabracq, M., & Winnubst, J. (2005). The role of

work-related and personal factors in diabetes self-

management. Patient Education and Counseling, 59(1),

87–96.

Wilkinson, J. M. (2012). Nursing process and

critical thinking (5th ed.). Upper Saddle River, NJ:

Pearson.

Wysocki, A. B. (1983). Basic versus applied research:

Intrinsic and extrinsic considerations. Western Journal

of Nursing Research, 5(3), 217–224.

65CHAPTER 2 Introduction to Quantitative Research

C H A P T E R

3 Introduction to Qualitative Research

C H A P T E R OV E R V I E W

Values of Qualitative Researchers, 67

Rigor in Qualitative Research, 68

Qualitative Research Approaches, 68

Phenomenological Research, 69

Grounded Theory Research, 70

Ethnographic Research, 74

Exploratory-Descriptive Qualitative

Research, 76

Historical Research, 78

Qualitative Research Methodologies, 81

Selection of Participants, 82

Researcher-Participant

Relationships, 82

Data Collection Methods, 82

Interviews, 83

Focus Groups, 85

Observation, 86

Text as a Source of Qualitative Data, 87

Data Management, 88

Organizing Data Files, 88

Transcribing Interviews, 88

Data Analysis, 88

Codes and Coding, 89

Themes and Interpretation, 89

Key Concepts, 90

References, 91

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Contrast the characteristics of qualitative

research with the characteristics of quantitative

research.

2. Describe five qualitative research approaches—

phenomenological research, grounded

theory research, ethnography, exploratory-

descriptive qualitative research, and historical

research.

3. Describe the intended outcome of each

qualitative approach.

4. Describe four ways that data may be collected in a

qualitative study.

5. Describe strategies used by qualitative

researchers to increase the credibility and

transferability of their findings.

6. Compare how data collected in an interview

might be different from data collected in a

focus group.

7. Critically appraise the collection, analysis, and

interpretation of data of qualitative studies.

K E Y T E R M S

Bracket, p. 69

Coding, p. 89

Dwelling with the data, p. 89

Emic approach, p. 74

Ethnographic research, p. 74

Ethnonursing research, p. 74

66

Etic approach, p. 74

Exploratory-descriptive

qualitative research, p. 77

Field notes, p. 86

Focus groups, p. 85

Focused ethnography, p. 74

Going native, p. 75

Grounded theory research, p. 70

Historical research, p. 78

Immersed, p. 74

Interpretation, p. 89

Key informants, p. 82

Moderator or

facilitator, p. 85

Observation, p. 86

Open-ended interview, p. 83

Participants, p. 82

Phenomena, p. 67

Phenomenology, p. 69

Primary source, p. 79

Probes, p. 83

Qualitative research, p. 67

Researcher-participant

relationship, p. 82

Rigor, p. 68

Secondary source, p. 79

Semistructured

interview, p. 83

Symbolic interaction

theory, p. 70

Transcripts, p. 88

Unstructured interview, p. 83

Qualitative research is a systematic approach used to describe experiences and situations from the

perspective of the person in the situation. The researcher analyzes the words of the participant,

finds meaning in the words, and provides a description of the experience that promotes deeper

understanding of the experience. You may empathize with a family member whose loved one

has had a heart transplant, for example, but have a limited appreciation for the perceptions of

the family member. How does your understanding change when you read the words of a family

member who has lived the experience? “On the day doctor said he [son] needed a transplant, my

world collapsed. I was depressed, feeling bad, bad, bad. Then I said: My son is going to need me.

I can’t get sick. Then I found my strength in that.” (Sadala, Stolf, Bocchi, & Bicudo, 2013, p.123).

Because caring about and wanting to help people are motivations for being a nurse, nurses value

qualitative research for the insight that it can provide. Qualitative research can generate rich

descriptions of the experiences of patients and families that increase nurses’ understanding

of the best ways to intervene and be supportive. As a result, qualitative findings make a distinct

contribution to evidence-based practice (Brown, 2014; Munhall, 2012).

This chapter introduces the values supporting qualitative research and presents an overview of

five qualitative perspectives commonly conducted in nursing—phenomenological research,

grounded theory research, ethnographic research, exploratory-descriptive qualitative research,

and historical research. An example of each type of study is described. You are introduced to

some of the more common methods used to collect, analyze, and interpret qualitative data.

This content provides a background for you to use in reading and comprehending published

qualitative studies, critically appraising qualitative studies, and applying study findings to your

practice.

VALUES OF QUALITATIVE RESEARCHERS

Qualitative researchers describe perspectives on various phenomena. Phenomena are the experi-

ences that comprise the lives of humans. An experience is considered unique to the individual,

time, and context, which is why qualitative researchers describe a phenomenon from the perspec-

tive of the persons who are experiencing the phenomenon. Qualitative researchers seek to provide

a holistic picture of phenomena guided by the following beliefs:

1. There are multiple, constructed realities because meaning is subjective (created by individuals)

and intersubjective (created by groups) (Munhall, 2012; Oliver, 2012).

67CHAPTER 3 Introduction to Qualitative Research

2. Knowledge is co-constructed by the persons involved in an interaction.

3. Human behavior, such as words and actions, are choices influenced by the past and present, as

well as by the physical, psychological, and social contexts of the behavior or experience

(Oliver, 2012).

4. Time and context influence individual and group perspectives.

The reasoning process used in qualitative research involves putting pieces together percep-

tually to make wholes. From this process, meaning is produced. Because perception varies with

the individual, many different meanings are possible (Munhall, 2012). The findings from a qual-

itative study lead to an understanding of a phenomenon in a particular situation and are not

generalized in the same way as a quantitative study. The meanings that emerge provide an initial

picture or theory of the phenomenon being studied. To move beyond the initial view, qualitative

researchers must remain open to different descriptions or explanations of the phenomenon

during data analysis and interpretation. The rigor or strength of a qualitative study is the extent

to which the identified meanings represent the perspectives of the participants accurately.

Rigorous qualitative methods can ensure that the researcher maintains an open perspective

on the phenomenon.

RIGOR IN QUALITATIVE RESEARCH

Scientific rigor is valued because the findings of rigorous studies are seen as being more credible

and of greater worth. Studies are critically appraised as a means of judging rigor. Rigor is defined

differently for qualitative research because the desired outcome is different from the desired out-

come for quantitative research (Grove, Burns, & Gray, 2013). Rigor is assessed in relation to the

detail built into the design of the qualitative study, carefulness of data collection, and thoroughness

of analysis. Qualitative researchers are expected to maintain an open mind and allow the meaning

to be revealed, even if the meaning is not what was anticipated (Munhall, 2012). The qualitative

researcher is expected to provide sufficient information in the published report so that the reader

can critically appraise the dependability and confirmability of the study (Petty, Thomson, & Stew,

2012). Studies that are dependable and confirmable can be said to have truth, value, or credibility.

The findings of a qualitative study cannot be generalized but may be applied “in other contexts or

with other participants” (Petty et al., 2012, p. 382). The extent to which the findings of a qualitative

study are dependable, confirmable, credible, and transferable is the degree of rigor that the study

has. Chapter 12 has more information about how to determine whether a study is dependable,

confirmable, credible, and transferable.

QUALITATIVE RESEARCH APPROACHES

Each of these five approaches is based on a philosophical orientation that influences the interpre-

tation of the data. For each approach, whether phenomenology, grounded theory, ethnography,

exploratory-descriptive qualitative research, or historical research, it is critical to understand

the philosophy on which the method is based. Each approach is discussed in relation to its phil-

osophical orientation and intended outcome. A nursing study is provided to illustrate each

methodology. Deciding which qualitative approach to use depends on the research question

and purpose of the study (Bolderston, 2012).

68 CHAPTER 3 Introduction to Qualitative Research

Phenomenological Research Philosophical Orientation Phenomenology refers to both a philosophy and a group of research methods congruent with the

philosophy that guide the study of experiences or phenomena (Dowling & Cooney, 2012). Phenom-

enologists view the person as integrated with the environment. The world shapes the person, and the

personshapestheworld.Thebroadresearchquestionthatphenomenologistsaskis,“Whatisthemean-

ing of one’s lived experience?” Being a person is self-interpreting; therefore, the only reliable source of

information to answer this question is the person (Mapp, 2008). Understanding human behavior or

experience, which is a central concern of nursing, requires that the person interpret the action or expe-

rience for the researcher; the researcher then interprets the explanation provided by the person.

Phenomenologists differ in their philosophical beliefs. Nursing phenomenological researchers

usually base their study design on Husserl or Heidegger, whose views of the person and the world

differ (Petty et al., 2012). Each of these philosophical perspectives supports a specific type of

phenomenological research.

Husserl’s view is that the focus is on the phenomenon itself and the meaning-laden statements

in the data that capture the essence or true meaning of what the participant perceives and expe-

riences (Dowling & Cooney, 2012). The meaning-laden statements are analyzed to discover the

structure within the phenomenon. Husserl’s philosophy supports descriptive phenomenological

research, whose purpose is to describe experiences as they are lived, or in phenomenological terms,

to capture the “lived experience” of study participants. To describe lived experiences, according to

Husserl, researchers must bracket or set aside their own biases and preconceptions to describe the

phenomenon in a naı̈ve way (Dowling & Cooney, 2012).

Heidegger argued that it was impossible to set aside one’s preconceptions and understand the

world naively. He believed that phenomenological researchers describe how participants have

interpreted their experiences (Converse, 2012) and interpret the data, looking for the hidden

meaning (Dowling & Cooney, 2012). The interpretative approach, consistent with Heidegger’s

philosophy, involves analyzing the data and presenting a rich word picture of the phenomenon

as interpreted by the researcher.

Hermeneutics is one type of interpretive phenomenological research method that is congru-

ent with Heidegger’s philosophical perspective and is being used by nurse researchers (Dowling

& Cooney, 2012). Hermeneutics involves textual analysis that begins with a naı̈ve reading of the

texts (Flood, 2010). Transcripts of interviews and published documents are the texts analyzed

by nurse researchers. From these naı̈ve readings, the researcher identifies sub-themes and

? CRITICAL APPRAISAL GUIDELINES Qualitative Studies

The following questions can be asked to appraise the qualitative approach of a study critically:

1. Was the clinical or practice problem that the study addressed a significant problem?

2. What was the research problem that the study was designed to address?

3. What was the purpose of the study? Did the researcher clearly state the purpose? Is the purpose of the study

consistent with using a qualitative research design?

4. Did the researcher identify the qualitative research approach used in the study?

5. Were the methods consistent with the qualitative research approach and its philosophical orientation?

6. Are the results consistent with the qualitative research approach used?

69CHAPTER 3 Introduction to Qualitative Research

themes that are examined in light of the study’s research questions. As the text, themes, and

relevant literature are integrated, a description of the phenomenon as interpreted is produced.

Phenomenology’s Outcome The purpose of phenomenological research is to provide a thorough description of a lived expe-

rience. Some researchers will summarize their findings with a written summary that combines the

findings into a thorough description or an exemplar of the experience.

Grounded Theory Research Grounded theory research is an inductive technique that emerged from the discipline of sociol-

ogy. The term grounded means the theory developed from the research has its roots in the data

from which it was derived. Most scholars base the grounded theory methodology on symbolic

interaction theory. George Herbert Mead (Mead, 1934), a social psychologist, developed symbolic

interaction theory, which involves exploring how people define reality and how their beliefs are

related to their actions. Reality is created by attaching meanings to situations. Meaning is expressed

in such symbols as words, religious objects, patterns of behavior, and clothing. These symbolic

RESEARCH EXAMPLE

Phenomenological Study

Research Study Trollvik, Nordbach, Silen, and Ringsberg (2011) conducted a phenomenological study of the lived experience of

children, ages 7 to 10 years, who had asthma. Two of the authors conducted 15 individual interviews with the par-

ticipants, who were recruited from children hospitalized for asthma. Conducting qualitative research with children

can be challenging because they may lack the cognitive ability to reflect on their experiences. To provide additional

data and another means of communication, the participants were asked to draw a picture of a situation that they

described in their interview. The pictures provided validation of the interview transcript and “provided a deeper

understanding of their life world and their inner thoughts” (Trollvik et al., 2011, p. 301).

Fromthe interview transcripts, the researchersidentified fivesubthemesthatwere foundtoform twoclustersofmean-

ing (themes). The first was fear of exacerbations. The children described realizing when their symptoms were worsening

as being not able to breathe, feeling tired, and fearing that they would lose control, especially when the symptoms

occurred at night. The children could not predict to what extent they could participate in activities with their friends.

The second theme was fear of being ostracized. Because asthma limited their activities at times, the childrenwere some-

times excluded or could not participate fully in physical activities with their friends. Not wanting to be seen as “differ-

ent,” the children sometimes continued an activity, even though their symptoms were worsening. They struggled with

feelings of loneliness and tried to limit the number of people who knew about their diagnosis (Trollvik et al., 2011).

Critical Appraisal Trollvik and colleagues (2011) provided information that supported the significance of the clinical problem of child-

hood asthma by noting that asthma is the most common childhood disease, can be life-threatening, and affects

physical activity and growth (significance). The research problem was that few studies of children’s perspective

of living with asthma had been done (research problem). The study’s purpose was consistent with using a qualitative

approach, and the researchers clearly identified phenomenology as the approach used. The methods used to collect

data (interviews and pictures drawn by the children) and analyze the data were explicit and consistent with phe-

nomenology and its philosophical orientation. In the report, the researchers connected the children’s drawings to

the themes and connected the themes to direct quotes of the participants to provide a rich description of the expe-

rience of living with asthma. The process of linked sources of data to themes increased the confirmability of the

study’s findings. Also included in the report were the study’s strengths and weaknesses, the acknowledgment of

which strengthened the study’s credibility. Another strength was that they used an additional data source (pictures)

because children may lack the cognitive and verbal skills for full expression of their perspectives.

70 CHAPTER 3 Introduction to Qualitative Research

meanings are the basis for actions and interactions. However, symbolic meanings are different for

each individual, and we cannot completely know the symbolic meanings for another individual. In

social life, meanings are shared by groups and are communicated to new members through social-

ization processes. Group life is based on consensus and shared meanings. Interaction may lead to

redefining a meaning or constructing new meanings. The grounded theory researcher seeks to

understand the interaction between self and group from the perspective of those involved.

Grounded theory has been used most frequently to study areas in which little previous research

has been conducted and to gain a new viewpoint in familiar areas of research. Through their inter-

views to understand the perspectives of persons who were dying, Glaser and Strauss (1967) devel-

oped grounded theory research as a method and published a book describing it as a qualitative

method. Nurses were attracted to the method because of its applicability to the life experiences

of persons with health problems and its potential for developing explanations of human behavior

(Wuerst, 2012). Nurse researchers continue to use grounded theory methods to study a wide range

of topics, such as the coping processes of persons with cancer (Chen & Chang, 2012), the conva-

lescence of survivors of intensive care a year after discharge (Ågård, Egerod, T�nnesen, & Lomborg, 2012), and troubled dating relationships of adolescents (Martsolf, Draucker, Bednarz, & Lea, 2011).

Intended Outcome

Fully developed grounded theory studies result in theoretical frameworks with relational state-

ments between concepts. Some grounded theorists provide a diagram displaying the interactions

among the social processes that were identified. For example, Fenwick, Chaboyer, and St. John

(2012) conducted a grounded theory study of the decision-making processes used by persons

to manage persistent pain. They found that persistent pain resulted in disruption of the known

self. The overall process of self-management was identified as “transforming the deciding self”

with three subprocesses: “degenerating self, disconnecting self, and preserving self” (p. 57). Their

diagram (Table 3-1) also identified the conditions influencing the disruption of self and actions

and consequences of the subprocesses. Based on their theory, nurses can recognize the type of deci-

sion making being used by a patient and have a context for intervening to move the patient to a

more productive type of decision making.

TABLE 3-1 INTERACTIONS AMONG SOCIAL PROCESSES

RELATED THEMES ! ACTIONS ! CONSEQUENCES Degenerating Self

Fearing alterations to the norm

Depleting personal energies

Struggling for the will to live

! Impulsive decision making ! Susceptible decision maker

Disconnecting Self

Cure chasing

Wavering self-confidence

Limiting self-confidence

! Bargaining decision making ! Adaptive decision maker

Preserving Self

Monitoring the self

Building boundaries

Partnering with others

! Judicious decision making ! Expert decision making

Adapted from Figure 3 of Fenwick, C., Chaboyer, W., & St John, W. (2012). Decision-making processes for the self-

management of persistent pain: A grounded theory study. Contemporary Nurse, 42 (1), 53-66.

71CHAPTER 3 Introduction to Qualitative Research

RESEARCH EXAMPLE

Grounded Theory Study

Research Study Excerpt Many nursing programs have integrated high-fidelity simulation into the learning activities of their curriculum to

promote the confidence, knowledge, and skills of student nurses. Despite the studies conducted related to simula-

tion, Walton, Chute, and Ball (2011) argued that the teaching method lacked theoretical support. They conducted a

grounded theory study to “gain understanding of how students learn with simulation and to identify basic social

processes and supportive teaching strategies” (p. 300). Based on their experiences as faculty and their review of the

literature, they presented four research questions to guide the study.

“The research questions that were addressed in this qualitative research study are as follows: (a) How do stu-

dentslearn using simulation?(b)Whatisthe processoflearning with simulationsfrom thestudents’ perspective?

(c) What faculty teaching styles promote learning? and (d) How can faculty support students during

simulation?” Walton et al., 2011, p. 300

Walton and co-workers interviewed 16 senior-level nursing students and analyzed the interview data over 1 year.

Their analyses identified the stages through which nursing students moved as they took on their professional roles.

“Negotiating theRole of the Professional Nurse wasthe core category, whichincludedthe followingfivephases:

(I)feelinglikean imposter, (II) trialanderror,(III)taking the roleseriously, (IV)transference of skillsand knowledge,

and (V)professionalization.Figure3-1 isaconceptualmodelof‘negotiating the role ofthe professionalnurse.’ The

boxes represent each of the phases, subcategories, and corresponding faculty strategies.” Walton et al., 2011,

p. 301

Students described the first phase of feeling like an imposter in terms of uncomfortable feelings. “Fear and anxiety

were seen in various degrees throughout each phase of ‘negotiating the role of the professional nurse’. . . . The stu- dents felt uncomfortable and fearful at the uncertainty of simulated scenarios” (Walton et al., 2011, p. 302). As the

students became more secure in what they knew in phase II, “they started to practice by volunteering to demonstrate

the tasks with faculty or peers”. . . and “appreciated gentle correction in their quest for improvement” (pp. 303, 304). Several students commented on practicing skills and responses to patient situations in their minds as they tried to

gain the maximum benefit from their time in the simulation laboratory. As they continued to develop, students

reported that they began to see themselves as team leaders and were able to assist other students. “Their uncertainty

and anxiety decreased during this transition as they demonstrated understanding of their role. They assimilated the

role of the professional nurse by growing in independence, advocating for clients, integrating into the healthcare

team, and looking for life direction. . . . They looked at what specialty fit with their lifestyle and personal needs,

as well as how they viewed themselves as professional nurses” (pp. 306-307).

The initial findings of Walton and colleagues (2011) were validated by two focus groups of students who had not

participated in the interviews. The students in the focus groups added the teaching behaviors that they perceived to

be supportive to each phase of the transition to professional nurse.

Critical Appraisal Walton and associates (2011) indicated the significance of the practice problem by stating that simulation as a teaching

method is being used worldwide, with limited theoretical understanding of the process that makes it effective. They

identified the qualitative research approach to be grounded theory, which is consistent with the need for learning about

social processes. They collected data through interviews and focus groups, coded the data to reveal the themes, and

provided direct quotes from students to support each subcategory in the transition process to professional nurse. Each

subcategory was clearly linked to a phase of the transition process. The researchers acknowledged their biases related to

simulation. The rigor of the study was also supported by the validation of the interview findings by seeking input from

additional students in focus groups. The transferability of the findings is limited somewhat because the study was con-

ducted at a religiously affiliated school of nursing with students who were primarily white.

Implications for Quality and Safety in Nursing Education To protect the safety of patients and ensure high-quality care, newly graduated nurses must internalize the role of the

professional nurse and participate as part of a healthcare team (Quality and Safety Education for Nurses [QSEN], 2013;

Sherwoood & Barnsteiner,2012). Waltonandco-workers (2011)provided a road map for this transition(seeFigure 3-1).

72 CHAPTER 3 Introduction to Qualitative Research

Subcategories

Phase I

Phase II

Phase III

Phase IV

Phase V

Feeling like an Imposter

Trial and Error

Taking the Role

Seriously

Transference

Professional- ization

Faculty Strategies

- Anticipatory socialization - Wanting specific instruction - Feeling disorganized - Feeling uncomfortable & anxious - Joking around - Wanting more structure -Struggling with spontaneity

Welcoming students Validating students’ feelings: Afraid, disorganized, overwhelmed Acknowledging that anxiety is normal Performance, equipment, testing It is okay to make errors Providing orientation, rules, dress code Demonstrating several times Explain expectations, debriefing

Encouraging repetition & practice Joking around is part of process Okay to make errors Give positive feedback on what students are doing correctly May need to re-demonstrate Debriefing with gentleness

Dressing the role in scrubs or lab coat Using nurse vocabulary Role modeling expectations Role modeling team skills Avoiding isolation of students Encouraging team building

Talking about abnormal or extreme patient response and coping with causing pain Learning from errors Allowing students to debrief each scenario, Providing positive feedback first Asking questions: How could we improve? Demonstrating immense patience

Developing collegial relationship Assisting students with visualizing goals Addressing students as “nurses” Promoting client advocacy Providing high-level simulations Avoiding interruptions in simulations

- Practicing, repetition, verbalizing - Joking to mask fear - Replaying scenario in head/minds - Reviewing errors–unsure of the role - Self-reflecting & self-forgiving - Mentoring other students

- Defining the scenario as real - Deciding to learn, getting into the role - Using nurse speak - Routinization - Building perspective in role of the nurse - Developing team leadership skills - Learning to analyze - Starting to pull it all together

- Emerging human perspective in clinical - Feeling confident in the role Skills, problem solving - Socialization of the role - Failing skill or making errors Disappointment, devastation Lack of confidence, cycle of fear - Rebuilding confidence

- Growing in the role - Advocating for clients - Integrating into the healthcare team - Looking into life direction–type of nursing

FIG 3-1 Phases of negotiating the role of the professional nurse. (From Walton, J., Chute, E., & Ball, L. [2011]. Negotiating the role of the professional nurse: The pedagogy of simulation: A grounded theory study. Journal of Professional Nursing, 27[5], 299-310.)

73CHAPTER 3 Introduction to Qualitative Research

Ethnographic Research Ethnographic research was developed by anthropologists as a method to study cultures through

immersion in the culture over time. The word ethnography means “portrait of a people.” Anthro-

pologists study a people’s origins, past ways of living, and ways of surviving through time—in

other words, their culture. Culture is the focus of ethnography. Early ethnography researchers stud-

ied primitive, foreign, or remote cultures (Savage, 2006). Such studies enabled the researcher who

spent a year or longer in another culture to acquire new perspectives about a specific people,

including their ways of living, believing, and adapting to changing environmental circumstances.

This reflects the emic approach, one of studying behaviors from within the culture that recognizes

the uniqueness of the individual (Ponterotto, 2005). The emic view from inside the culture is the

typical goal of ethnography. The etic approach involves studying behavior from outside the cul-

ture and examining similarities and differences across cultures. Etic approaches are more fre-

quently used by anthropologists or sociologists in contrast to nurses, who tend to use an emic

approach. Nurses, however, may not observe a culture over months or years, but may observe

an organizational culture for a shorter time to learn about the culture of a hospital or healthcare

organization. This type of study is called a focused ethnography (Savage, 2006). Observations

shorter than months or years are appropriate when the research question is narrower, and the

scope of the study is limited to a specific place or organization.

The philosophical perspective of ethnographic research is based in anthropology and recognizes

that culture is material and nonmaterial. Material culture consists of all created or constructed

aspects of culture, such as buildings used for cultural events, symbols of the culture, family tradi-

tions, networks of social relations, and the beliefs reflected in social and political institutions. Sym-

bolic meaning, social customs, and beliefs—components of the nonmaterial culture—may be

apparent in a different culture only over time, but are essential elements of cultures. Cultures also

have ideals that people hold as desirable, even though they do not always live up to these standards.

Anthropologists and nurse ethnographers seek to discover the multiple parts of a culture and

determine how these parts are interrelated. A picture of the culture as a whole becomes clearer.

The nurse who increased the visibility of ethnography within nursing was Madeline Leininger,

who earned her doctoral degree in anthropology. The fieldwork for her degree was a year that she

spent in Papua New Guinea. From this experience, she developed the Sunshine Model of Trans-

cultural Nursing Care, which identifies aspects of culture to consider when communicating with

patients and families of another culture (Leininger, 1988). Nurses use Leininger’s Theory of Trans-

cultural Nursing (Leininger, 2002) in practice by assessing multiple aspects of the patient, family,

and their environment, including religion, societal norms, economic status, country of origin, eth-

nic subgroup, and beliefs about illness and healing. This theory has led to an ethnographic research

strategy for nursing, termed ethnonursing research. Ethnonursing research “focuses mainly on

observing and documenting interactions with people [and] how these daily life conditions and

patterns are influencing human care, health, and nursing care practices” (Leininger, 1985,

p. 238). However, a number of nurse anthropologists not associated with the ethnonursing orien-

tation are also providing important contributions to nursing’s body of knowledge (Roper &

Shapiro, 2000).

The ethnographic researcher must become very familiar with the culture being studied by

observing the culture, actively participating in it, and interviewing members of the culture. The

process of becoming immersed in a culture involves being in the culture and gaining increasing

familiarity with aspects of the culture, such as language, sociocultural norms, traditions, and other

social dimensions, including family, communication patterns (verbal and nonverbal), religion,

74 CHAPTER 3 Introduction to Qualitative Research

work patterns, and expression of emotion. Through immersion, the ethnographic researcher

becomes increasingly accepted into the culture. Although ethnographic researchers must be

actively involved in the culture they are studying, they must avoid “going native,” which would

interfere with data collection and analysis. In going native, the researcher becomes a part of

the culture and loses the ability to observe clearly (Roberts, 2009).

Intended Outcome The ethnographer prepares a written report based on the analysis of the culture. Depending on the

initial research question, the researcher may propose strategies to increase the cultural acceptability

of a health intervention, encourage health promotion behaviors, or improve the quality of care that

is being delivered in an organization. For example, a group of nurse researchers conducted an eth-

nographic study of family presence when their loved ones were being weaned from mechanical

ventilation (Happ et al., 2007). They collected data by watching the family members of 30 patients

during weaning and described their “active engagement in the observation and interpretation” of

the patient’s status as surveillance (p. 51). The researchers recommended that the typography of

family member behaviors they developed “could enhance the dialogue about family-centered care

and guide future research on family needs and presence in the ICU” (p. 56).

RESEARCH EXAMPLE

Ethnographic Research

Research Study Excerpt In another example, Portacolone (2013) was concerned about older adults living alone and conducted an ethnog-

raphy that involved collecting data over several years about older adults as individuals, relationships between the

older adult and institutions in the community, and the larger social problems affecting the person. To collect the data

in an unobtrusive manner, Portacolone served as a Meals on Wheels volunteer, delivering meals to older adults living

at home. She also conducted interviews with a purposive sample of 47 older adults living alone and additional inter-

views with officials who worked with agencies providing services to older adults.

“Most of the encounters occurred in the informants’ home. During the encounter, I engaged in any activity

suggested by the informant: this comprised eating and drinking, watching TV, looking at pictures, talking with

their friends or home care aides, doing yoga, singing, or walking. As I spent time with each informant, I found

the time to ask questions related to their experience of living alone. Their answers were recorded in an audio-

recorder and transcribed verbatim. To capture the fresh observations and reflections spurred by each encoun-

ter, field notes were written soon after leaving the premises” (Portacolone, 2013, p.168).

The researcher described how the notion of precariousness began to emerge.

“As I was listening to their account, I often felt the sense of ground failing beneath my feet. I translated these

impressions in my own words as ‘precariousness.’ One informant in particular—Paul, a 92-year retiree—

strongly gave me the essence of this sensation, which I then re-encountered—in different shapes and

flavors—in other informants. The more informants I encountered, the more this image took shape. The word

precariousness, as already mentioned, evokes a sense of insecurity and uncertainty stemming from the

vanishing of resources from multiple angles” (Portacolone, 2013, p. 169).

Portacolone (2013) examined the data at the micro level, focusing on the individual, and provided stories and

examples of precariousness. At the meso level of analysis, the older adult interacted with his or her family and mul-

tiple community organizations and institutions. Families were described as not always being able to provide con-

sistent support because of distance, work responsibilities, and strained relationships. The resources that

organizations provided required effort on the part of the older adult to obtain information and arrange to receive

services. At the macro level, the values that older adults in the United States place on independence and Continued

75CHAPTER 3 Introduction to Qualitative Research

Exploratory-Descriptive Qualitative Research As you read qualitative study reports, you may find that some researchers did not identify a par-

ticular approach to their study, such as phenomenology or grounded theory. Some researchers

have described their studies as being naturalistic inquiry, descriptive, or just qualitative. For exam-

ple, Letourneau and colleagues (2011) designed their study to “describe service providers’ under-

standing of the impact and dynamics of IPV [intimate partner violence] . . . and the unique needs, resources, barriers, and desired supports of these mothers” (p. 194). Nowak and Stevens (2011)

indicated the purpose of their “qualitative, descriptive” study with parents who had experienced

fetal loss as being “to identify and describe factors associated with this high-risk population”

(p. 123). Researchers design qualitative studies such as these to obtain information needed to

RESEARCH EXAMPLE—cont’d

individualism were viewed as patriotic and embedded in the larger culture. “Individuation feeds precariousness as

the number of challenges faced by older solo dwellers compound, physical and mental resources decrease, income

remains fixed or decreases, and older solo dwellers see themselves as the sole [person] responsible for their situation”

(p. 172). Portacolone (2013) offers interdependence as a viable alternative to independence that would “decrease the

need of older adults to prove to the outside world that they can make it alone. Within this new paradigm, older

adults living alone will not be afraid to ask for help, as they will be aware that doing so will not lead to a forced

move into an institution” (p. 173).

Critical Appraisal The Portacolone (2013) study is significant because of the increasing numbers of older persons living alone,

although no statistics about the number of older persons living alone were included. Usually, the researcher would

have included statistics as evidence supporting the significance of the study. However, because the study report was

published in the Journal of Aging, the researcher may have assumed that readers were most likely aware of these

statistics. The research problem and purpose of the study were consistent with the ethnographic method, which

was identified in the abstract as the approach of the study. The methods were developed to be consistent with eth-

nography and its philosophical orientation.

Portacolone’s (2013) observations occurred over extended periods of time, which allowed identification of impres-

sions that were validated through additional observations. The number and depth of interviews also strengthened

the findings. Sufficient quotes and specific examples were provided as evidence of the researcher’s conclusions.

Because of the rigorous methods used, the study was high quality, but with two identified weaknesses. The first

was that the researcher did not identify her own age, cultural background, and potential biases. The second more

serious weakness was the omission of any discussion about obtaining institutional review board (IRB) approval and

informed consent from the participants.

Implications for Practice Older persons living alone recognized that their situation was precarious and that events beyond their control could

result in not being able to continue living alone (Portacolone, 2013). The essential resources of financial stability and

physical health were interrelated and carefully managed to maintain their living situation. Nurses in hospitals,

clinics, and homecare need to recognize that the older person may not ask for help for fear of an outside authority

determining the person can no longer live at home. As a result, nurses may need to be sensitive to these concerns

when offering additional services to older persons living alone.

QSEN Implications Teams of healthcare professionals collaborate to provide patient-centered care (Sherwood & Barnsteiner, 2012).

Nurses and social workers can use the findings of this study as they work together to address the physical and social

needs of older adults living alone.

76 CHAPTER 3 Introduction to Qualitative Research

develop a program or intervention for a specific group of patients. Usually, the researchers are

exploring a new topic or describing a situation, so we have chosen to label these studies as

exploratory-descriptive qualitative research (Grove et al., 2013). Studies consistent with this

approach are not a specific type of research; rather, they are studies conducted for a specific pur-

pose that do not fit into another of the categories (Sandelowski, 2000, 2010).

Philosophical Orientation Exploratory-descriptive qualitative studies are developed to provide information and insight into

clinical or practice problems. Qualitative studies are often developed to address problems in prac-

tice but approach the problem differently. The philosophical orientation of exploratory-

descriptive qualitative research may vary, depending on the purpose of the study, but often the

researcher has a pragmatic orientation (McCready, 2010). The pragmatic researcher is in search

of useful information and practical solutions (Creswell, 2013) and designs studies to understand

what works (Houghton, Hunter, & Meskell, 2012). Letourneau and associates (2011) were con-

cerned about the needs of families that had been affected by IPV and the extent to which the care

and services being provided met the needs of their clients. The study provided the information on

which a solution could be based.

Intended Outcome A well-designed, exploratory-descriptive qualitative study answers the research question. The pur-

pose of the study is achieved, and the researchers have the information they need to address the

situation or patient concern that was the focus of the study. The findings of the study are applied to

the practice problem that instigated the inquiry. In the study of Letourneau and co-workers (2011),

for example, the researchers reported that service providers recognized internalizing and external-

izing behaviors of children in families affected by IPV. The service providers also described the

instrumental, informational, emotional, and affirmational support needed by women affected

by IPV. These findings could be applied to refining the services provided to families affected by IPV.

RESEARCH EXAMPLE

Exploratory-Descriptive Qualitative study

As noted, Nowak and Stevens (2011) addressed another social problem in their exploratory-descriptive qualitative

study. In a region with a high fetal mortality rate, they identified the research problem to be a need for more infor-

mation about “the circumstances and contexts in which individuals experience loss” (p. 123).

“Women who had experienced a fetal or infant loss were recruited using purposive sampling technique. . . .

[D]ata from fetal losses as early as 14 weeks were also collected due to the disproportionate number of

losses that occurred between 14 and 19 weeks of gestation. . . . The sample consisted of four African Amer-

ican, four White, and three Hispanic women. Of the men that participated, one was African American, two

were White, and one was Hispanic. Average time from death to interview was 3 months after fetal deaths

and 6 months for infant deaths. . . . After obtaining informed consent, the researcher conducted a tape-

recorded interview of 1 to 3 hours duration (Nowak & Stevens, 2011, p. 123).

The tape recordings were transcribed and the transcriptions were verified prior to data analysis. “Each interview was

read several times. Thoughts and themes that emerged with each reading were recorded in a narrative fashion as journal

entries (Bloomberg & Volpe, 2008). . . . Themes were grouped into broad categories that represented the final analysis results. . . We defined vigilance as ‘doing everything possible to help this baby make it’ by being continually alert and responsive despite poverty, healthcare inequity, and stress” (Nowak & Stevens, 2011, p. 124). The researchers continued

Continued

77CHAPTER 3 Introduction to Qualitative Research

Historical Research Historical research examines events of the past. Many historians believe that the greatest value of

historical knowledge is increased self-understanding; in addition, historical knowledge provides

nurses with an increased understanding of their profession. Connolly and Gibson (2011) con-

nected the topic of their historical study, the role of nurses in children with tuberculosis (TB) from

1900 to 1935, to the roles nurses need to assume today to change current healthcare policy.

Thompson and Keeling (2012) described in depth how nurses were involved in preventing infant

mortality between 1884 and 1925.

Philosophical Orientation

The major assumption of historical philosophy is that lessons can be learned from the past. His-

torians study the past through oral and written reports and artifacts, searching for patterns that can

lead to generalizations. For example, to answer the question—“What causes epidemics?”—a his-

torian could search throughout history for commonalities in various epidemics and develop a the-

oretical explanation of their causes. The philosophy of history is a search for wisdom in which the

historian examines what has been, what is, and what ought to be. Historical philosophers have

attempted to identify a developmental scheme for history to explain events and structures as ele-

ments of the same social process. Some nurses who conduct historical research have studied nurses

RESEARCH EXAMPLE—cont’d

by describing vigilance that occurred in “environments of violence, poverty, and stress” and supported the theme with

quotes from interviews (p. 124). Vigilance also was described “in the context of early pregnancy,” “in sensing change in

their bodies,” “in sensing change in their babies,” and “in findings answers” (pp. 125-127).

“The importance of vigilance in parents’ experiences in fetal and infant mortality was a key finding in the cur-

rent study. The finding has been infrequently reported in the literature. Participants shared stories that dem-

onstrated their vigilance in early pregnancy, as well as later when they sensed negative changes in

themselves or their babies. They were vigilant because of prior losses and were vigilant in finding answers

to their losses when explanations of their babies’ deaths were not clear. . . . Despite their desire for healthy

pregnancies and healthy infants, the many life challenges that the study participants experienced may have

contributed to their risk for fetal and infant loss” (Nowak & Stevens, 2011, p. 128).

Critical Appraisal The researchers described fetal infant loss in a specific community. As is appropriate for qualitative studies, the sample

of 15 parents was purposively selected because of their experiences with the phenomenon of interest. Thus, the sample

size and sampling method were appropriate for a qualitative study. The structured interview guide was included, as well

as an explanation of how the researchers used open-ended questions to elicit more information. The poignant quotes

that were included provided glimpses into the experiences ofthe participants so that readerscouldrecognize and empa-

thize with the parents’ experiences of fetal and infant losses. The findings were discussed in the context of existing lit-

erature,with the researchers notingthe contribution of thesefindingstothe literature.The study reportcouldhave been

stronger if the researchers had included additional information about protection of human subjects, such as referral to

psychosocial supports to address the continuing emotional impact of the loss and to community resources to remedy

the social conditions that may have contributed to the losses experienced by the parents.

Implications for Practice By recognizing the effects of poverty, violence, and inadequate access to care, nurses who provide care during times

of fetal and infant loss can be more sensitive to the efforts made by the women and their partners to prevent the loss.

Referrals can be made to address these issues, as appropriate.

78 CHAPTER 3 Introduction to Qualitative Research

and their roles at critical turning points in the profession. Historical nurse researchers believe that

nursing as a profession has a history that must be transmitted to those entering the profession as

part of their socialization process. Other historical nurse researchers have identified events in

health care with the intent of encouraging the readers of the report to learn from the successes

and failures of the past.

Historical researchers may collect data by interviewing people with knowledge of events, espe-

cially for more recent events. For example, a historical researcher studying army nursing during

deployments to Vietnam during the 1970s could interview nurses who served there, because some

of them are still living. The interview of a person who played a role in the historical event is con-

sidered a primary source of data. Other primary sources are documents written by the person

being studied. For example, a diary kept by a nurse while she was deployed to a war zone would

be a primary source for the study. Before using it as a source of data, the researcher would confirm

with the author that the diary was an authentic document. If the author was not alive, the

researcher would seek evidence to confirm authorship. Once documents are authenticated, the

researcher would rely more heavily on them as primary sources. However, people who lived at

the same time or those who heard stories of that time may provide information to provide breadth

and depth to the description that the researcher is developing. These people are secondary sources

of data. When primary sources are few or inaccessible, historical researchers rely on secondary

sources. The researcher studying army nurses in Vietnam in the 1970s might interview military

veterans who received care from the nurses, review newspaper articles from the time, and read

army documents used to prepare nurses entering the military at that time. The secondary sources

may confirm, expand, or provide an opposite viewpoint to what is available from the primary

sources.

Intended Outcome

Historical researchers provide a description of a series of events, a chronology of factors that

affected the topic of interest. Reports from historical studies are written differently than reports

for other types of studies in that they include limited information about the methods used and

have a greater focus on the story being told. Some historical researchers publish a book of their

findings rather than publishing them in a journal article. Studies using this approach provide

exemplars of nurses who changed health care by their leadership in a specific social or political

time and place. The findings of other historical studies have inspired nurses to address current

social and political issues and have provided insight into environmental forces that shaped events

affecting health care at different times in history.

RESEARCH EXAMPLE

Historical Research

Research Study Excerpt Connolly and Gibson (2011) conducted a historical study of tuberculosis, race, and children to describe “nurses’

efforts at early twentieth century pediatric TB prevention and treatment in one state, Virginia” (p. 231). To support

the study’s purpose, they linked the study to current healthcare legislation and changes.

“What can history contribute to our understanding of 21 st century children’s health care? . . .There are several

reasons for doing so. First, much research on children’s health lacks a meaningful historical dimension. But

the values, norms, policies, and institutions that template pediatric nursing today are all predicated on Continued

79CHAPTER 3 Introduction to Qualitative Research

RESEARCH EXAMPLE—cont’d

decisions made in the past. As such, a better understanding of the negotiations and debates that shaped

contemporary practice and policy can facilitate a more meaningful consideration of how best to deliver health

care today and in the future.” Connolly & Gibson, 2011, p. 231

As is typical with reports of historical studies, the researchers do not describe their methods in the report. They

delineated the period of interest, 1900 to 1935, and the specific disease, TB, in the context of society in the state of

Virginia. A pervasive reality of that time was racism and the resulting segregation. “In Virginia, because public health

reform was intricately bound to a value system that sought to reinforce the state’s existing racial and class hierarchy,

nurses, physicians, and others practiced within a framework that restricted their options” (Connolly & Gibson,

2011, p. 232). They described the result of the societal values in terms of a health disparity using government sta-

tistics. “Nationwide, non-White youngsters between the ages of 5 and 14 years died of TB at a rate of 155 per 100,000,

compared to 23 per 100,000 TB death for White children” (Rogers, 1917, p. 231).

Within the temporal and geographic context, Connolly and Gibson (2011) explored the responses of nurses in

public health institutions to TB as a threat to the public:

“Many of the early 20th century anti-TB initiatives designed by Virginians were led by, or crafted with heavy

input from, public health nurses. . . . Richmond’s Nurses Settlement was founded in 1900 to provide nursing

care to the sick poor and incorporated in 1902 as the Instructive Visiting Nurse Association (IVNA), with the

explicit goal of bringing nursing care to people in their homes. The nurses themselves funded the operation,

donating their own money and garnering support from private charities and the public health department. In

Norfolk, the King’s Daughters Visiting Nurse program (a nondenominational Christian women’s organization)

also responded to the needs of Black patients when, in 1910, they hired their first Black nurse to care for

‘Negro women and children.’ The perceived need was so great for the services of this nurse that another

Black nurse was hired within the first 3 months (Norfolk City Union of the King’s Daughters Annual Report

for 1910).” Connolly & Gibson, 2011, p. 233

By using a timeline with key events (see Figure 3-2), Connolly and Gibson (2011) provided a visual representation

of changes that occurred over time. They described the transition from TB treatment to prevention, which led to the

creation of a “preventorium for those children not yet sick with TB” (p. 235). Agnes Dillon Randolph, a public health

nurse with political connections, was credited with identifying a way to fund prevention through the sale of Christ-

mas seals. “In an effort to fund as many preventoria and other TB programs as possible, the National Tuberculosis

Association (NTA) worked with local officials like Randolph to make sure that its annual Christmas Seal campaign

was a lucrative community and a national event” (Knopf, 1922, p. 235).

The researchers concluded the report by emphasizing the lessons from 1900 to 1935 that can be applied today.

“Perhaps the most important legacy of Virginia’s public health nurses is one that we can use today.

Unwilling to be trapped by conventional wisdom, the patterns of the past, or accept the status quo, they

drew on all of the resources they could muster to innovate new models of health care. So, too, can

today’s nurses challenge historical precedent to improve the well-being of all Americans.” Connolly &

Gibson, 2011, p. 237

Critical Appraisal The abstract is a clear, succinct summary of the study and its results.

“Drawing on a wealth of primary documents, this historical research describes nurses’ efforts regarding early

20th century pediatric tuberculosis care in Virginia. Virginia nurses played a leadership role in designing a tem-

plate for children’s care. Ultimately, however, their legacy is a mixed one. They helped forge a system funded

by a complicated, poorly coordinated, race- and class-based mix of public and private support that is now

delivered through an idiosyncratic web of community, state, and federal programs. However, they also took

courageous action, and their efforts improved the lives of many children. By so doing, they helped invent

pediatric nursing” (Connolly & Gibson, 2011, p. 230).

Connolly and Gibson (2011) began their report by explicitly stating the study’s relevance to current changes in

health care. Another strength is the use of primary sources. Of the 52 sources cited in the report, 28 were published

between 1900 and 1935. For example, the researchers documented the veracity of their findings by citing annual

80 CHAPTER 3 Introduction to Qualitative Research

QUALITATIVE RESEARCH METHODOLOGIES

This section presents a detailed description of the methods commonly used in conducting qual-

itative studies. In some ways, the methods used are no different from those used in quantitative

studies. The researcher must select a topic, state the problem or question, justify the significance of

the study, design the study, identify sources of data, such as subjects, gain access to those sources of

reports of organizations providing care, diaries of children who lived in preventoria, government reports, and other

original documents that are part of historical collections in libraries. To understand the context better, the

researchers also provided information from secondary sources, such as books and articles by historians. The timeline

the researchers developed (see Figure 3-2) was a clear way to summarize and portray the critical events they

described.

The report is appropriately written as a chronology but could have been strengthened by contrasting the positive

and negative aspects of the nurses’ legacy throughout the body, instead of only in the abstract. Also, the perspectives

of black nurses and children seem to be missing from the report.

Implications for Practice The courageous actions of Agnes Dillon Randolph and Nannie Minor, the only other nurse named in the report, can

inspire nurses today to take a stand against discrimination and injustice in the distribution of health care.

Koch isolated tubercle bacillus

1882

1893

King’s Daughters Visiting Nurse

Service Norfolk founded

Henry St Settlement

founded NY

Richmond IVNA

founded

First black visiting nurses hired, Norfolk

King’s Daughters

CCH incorporated black & white

children cared for at MCV hospitals

CCH opens for white children

Richmond

First convalescent beds for black

children Tidewater

CCH–Crippled Children’s Hospital IVNA–Instructive Visiting Nurses Association SSA–Social Security Act BRS–Blue Ridge Sanatorium MCV–Medical College of Virginia

1897 Von Pirquet

screening test for TB

available

1907 Piedmont Sanitorium for blacks

opens (no dedicated pediatric beds)

1917 BRS opens dedicated pediatric beds for white children

1922 SSA

passed

1935 Streptomycin therapy for

TB first used successfully

1944

1880 1890 1900 1910 1920 1930 1940

1900 1910 1920 1928 1940

1950

FIG 3-2 Landmark moments in pediatric TB prevention in Virginia. (From Connolly, C., & Gibson, M. [2011]. The “White Plague” and color: Children, race, and tuberculosis in Virginia 1900-1935. Journal of Pediatric Nursing, 26, 230-238.)

81CHAPTER 3 Introduction to Qualitative Research

data, recruit subjects, gather data, describe, analyze, and interpret the data, and develop a written

report of the results and findings. There are, however, methods unique to qualitative studies and

sometimes to specific types of qualitative research. An understanding of some of the unique

methods used by qualitative researchers will help you appreciate the efforts involved in conducting

such a study.

This section describes how participants (subjects) are selected and how data are collected, man-

aged, and analyzed. The methods used to ensure rigor in qualitative research also are explored.

Selection of Participants Subjects in qualitative studies are referred to as participants because the researcher and partici-

pants carry out the study cooperatively. The researcher recruits participants because of their par-

ticular knowledge, experience, or views related to the study (Munhall, 2012).

Researcher-Participant Relationships One of the important differences between quantitative and qualitative research lies in the degree of

involvement of the researcher with the participants of the study. This involvement, considered to

be a source of bias in quantitative research, is thought by qualitative researchers to be a critical

element of the research process. The nature of the researcher-participant relationship has an

impact on the collection and interpretation of data (Maxwell, 2014). The researcher creates a

respectful relationship with each participant, which includes being honest and open about the pur-

pose and methods of the study. The researcher’s aims and means need to be negotiated with the

participants and honor their perspectives and values (Grove et al., 2013; Maxwell, 2014; Munhall,

2012). In various degrees, the researcher influences the people being studied and, in turn, is influ-

enced by them. Thus the researcher must have their support and confidence to complete the

research. The researcher’s personality is a key factor in qualitative research. Skills in empathy

and intuition are cultivated; the researcher must become closely involved in the subject’s experi-

ence to interpret it. It is necessary for researchers to be open to the perceptions of the participants,

rather than to attach their own meaning to the experience.

Researcher-participant relationships in qualitative studies may be brief when data collection

occurs once in an interview or focus group. Phenomenology and grounded theory studies may

involve one or two interviews, although researcher-participant relationships may extend over time

when the study design involves repeated interviews to study a lived experience or process over time.

Ethnographic studies require special attention to the researcher-participant relationship. The

ethnographic researcher observes behavior, communication, and patterns within groups in specific

cultures. The researcher may form close bonds with participants who are key informants, persons

with extensive knowledge and influence in a culture. The relationships among the researcher and

participants can become complex, especially in ethnography studies in which the researcher lives

for an extended time in the culture being studied.

DATA COLLECTION METHODS

The data in most qualitative research studies are “the participant’s thoughts, ideas, and percep-

tions” (Bolderston, 2012, p. 68). The most common data collection methods used in the types

of qualitative studies discussed in this chapter are interviewing participants, conducting focus

groups, observing participants, and examining written text. These methods, as they are used in

qualitative studies, are described in the following sections in some detail; examples from the lit-

erature are provided.

82 CHAPTER 3 Introduction to Qualitative Research

Interviews Differences exist between interviews conducted for a qualitative study and those conducted for a

quantitative study. In quantitative studies, researchers structure interviews to collect subject

responses to questionnaires or surveys (see Chapter 10). Interviews in qualitative studies range

from semistructured interviews (fixed set of questions, no fixed responses) to unstructured

interviews (open-ended questions, with probes). Probes are queries made by the researcher to

obtain more information from the participant about a particular interview question.

For unstructured interviews, also called open-ended interviews, the initial statement or ques-

tion may be “Tell me about a time that you received bad news about a diagnostic test” or “After

your diagnosis, how did you learn about diabetes?” Although the researcher defines the focus of the

interview, there may be no fixed sequence of questions. The questions addressed in interviews tend

to change as the researcher gains insights from previous interviews and observations. Respondents

are allowed, and even encouraged, to raise important issues the researcher may not have addressed.

The researcher’s goal is to obtain an authentic insight into the participant’s experiences.

Although data may be collected in a single interview, dialogue between researcher and participant

may continue at intervals across weeks or months and provide rich data for analysis. Use of recur-

ring interviews allows the researcher to explore an evolving process (Munhall, 2012) and allows the

researcher-participant relationship to develop. As the relationship develops and trust grows, the

participant may reveal the emotional and value-laden aspects of the process more freely.

The purpose of the interview may vary, depending on the type of qualitative approach. Inter-

views in a phenomenology study may have one main question, with follow-up questions used as

needed to elicit the participant’s perspective on the phenomenon. Interviews in grounded theory

studies are similar in that only one or two questions may be asked, but the follow-up questions will

focus on the social processes of the phenomenon. In an exploratory-descriptive qualitative study,

the interviewer may ask more structured questions to achieve the purpose of the study. Historical

researchers may interview people who were participants in or observers of events that occurred in

the past. The focus of the interview may be to validate available information about the event,

uncover details previously not known about the event, or obtain views about the event from those

who were not heard from previously. Interviews can also be used to construct the participants’

biographies. The personal histories of a number of persons can be used to understand the evolving

history of a region or institution.

Some strategies used to record information from interviews include writing notes during the

interview, writing detailed notes immediately after the interview, and recording the interview.

Video may be recorded, as well as audio. For example, audio recordings were used to record tele-

phone interviews of hospital administrators to describe the mental health services provided for

female veterans in Veterans Affairs Medical Centers across the United States (MacGregor,

Hamilton, Oishi, & Yano, 2011). Telephone interviews were the most feasible way to collect data

in this study.

Interviews should be arranged for a time and private place convenient for the participant. Inter-

views may be held in the participant’s home, clinic office, public library meeting room, or restau-

rant. A place where the interview is less likely to be interrupted and the participant feels secure is

more helpful. Meeting in a clinic, for example, may not be appropriate if the interview involves

describing the care being received. A person living with an infection caused by the human immu-

nodeficiency virus (HIV) may not want to be interviewed in a place where he or she might be seen

by friends or family. You also want a place that is quiet enough to allow for effective audio

recording.

83CHAPTER 3 Introduction to Qualitative Research

? CRITICAL APPRAISAL GUIDELINES Interviews in Qualitative Studies

When critically appraising studies in which data were collected by interview, address the following questions:

1. Were the strategies used to recruit the participants and obtain informed consent described in the research

report?

2. Did the researchers report the length of the interviews? The length of the interviews are usually reported as a

range of time.

3. Did the report include information on the questions and prompts used to facilitate the interview?

4. Does the length of the interviews seem adequate for the number and type of research questions? For exam-

ple, if the researcher indicated that the interviews ranged in length from 10 to 30 minutes and the researcher

asked each participant five open-ended questions, you might raise a concern about whether the participants

had enough time to provide in-depth answers.

RESEARCH EXAMPLE

Interview

Research Study Excerpt McDermott-Levy (2011) conducted interviews in her study of Arab-Muslim female students in a baccalaureate

nursing program in the United States. She prepared an initial question and probing questions to elicit descriptions

of their experiences of living and studying in the United States.

“The women participated in individual audiotaped interviews in a private conference room at the University.

This ensured privacy of the students’ responses, which facilitated openness. . . . The women were

asked open-ended questions related to their experience of being Arab-Muslim women living and studying

nursing in the United States. . . . Each interview was conducted in English and lasted from 1-1.5 hours.

The interviews were conducted in English because the participants had a trusting relationship with the

English-speaking investigator and were successful in their academic program for 12 months prior to data

collection.” McDermott-Levy, 2011, p. 269

Critical Appraisal The researcher described the context and the length of the interviews and provided the rationale for the decisions

that were made. The length of the interview allowed adequate time for substantive responses to be provided.

One concern was that the researcher who conducted the interviews was the students’ academic advisor. Because

Oman culture values personal relationships and the protection of one’s privacy, having the interviewer be some-

one trusted by the participants outweighed the potential disadvantage that social desirability might influence

the information that the participants were willing to share. The risk of feeling coerced to participate was mini-

mized by having another person recruit participants and obtain informed consent. The investigator concluded

that the pre-existing trust allowed the participants to be more open and share their challenges, as well as their

growth.

Implications for Practice The participants had learned new behaviors, such as managing money, using a budget, going out independently, and

dealing with anti-Muslim prejudices. Having left the security of their families, they reported a sense of “going alone,”

but acknowledged that the experience has helped them grow in life management skills. The implications of the study

were for nurse educators to provide support services for international students and adapt their teaching styles to a

wide range of cultures and learning styles.

84 CHAPTER 3 Introduction to Qualitative Research

Focus Groups Focus groups were designed to obtain the participants’ perceptions of a specific topic in a per-

missive and nonthreatening setting. One of the assumptions underlying the use of focus groups

is that group dynamics can help people express and clarify their views in ways that are less likely

to occur in a one-to-one interview. The group may give a sense of “safety in numbers” to those

wary of researchers or those who are anxious. The recommended size of a focus group is five

to eight participants. Larger focus groups are sometimes used but may be more difficult to mod-

erate. All participants should have the opportunity to speak, which may be more difficult to

achieve with a larger number. Focus groups are sometimes called group interviews

(Bolderston, 2012), so the principles of interviewing such as responding in a nonjudgmental

way are still applicable.

Focus groups are conducted by a moderator or facilitator, who may or may not be the

researcher. Researchers may elicit the help of moderators who share common characteristics with

the participants. An example would be the urban researcher who hires a health professional who

grew up in a rural farming community to moderate a focus group on preventing agricultural inju-

ries. Moderators should be thoroughly trained and understand the importance of following the

procedures or script developed by the researcher (Gray, 2009).

The entire interaction is audio-recorded and, some cases, video-recorded. In addition to the

recording, members of the research team may serve as observers to take notes of the proceedings.

Integrating her personal experiences in conducting focus groups with the recommendations in the

literature, Gray (2009) proposed that focus groups be conducted in natural settings, but noted that

the researcher must plan ahead to protect the confidentiality and comfort of the participants.

Confidentiality and comfort may result in richer dialogue and data.

? CRITICAL APPRAISAL GUIDELINES Focus Groups

When critically appraising studies in which data were collected using focus groups, address the following

questions:

1. Were the strategies used to recruit the participants and obtain informed consent described in the research

report?

2. Did the researchers describe the number, composition, length, and setting of the focus groups?

3. Did the number, composition, and length of the focus groups seem appropriate for the research question?

4. Was the setting conducive for increasing the comfort of the participants and protecting confidentiality?

RESEARCH EXAMPLE

Focus Groups

Research Study Excerpt Researchers studying the strength of older adults had previously focused on different types of strength, such as phys-

ical or psychological. Rush, Watts, and Janke (2013) identified that no evidence existed as to whether older adults’

viewed strength in a compartmentalized way. They conducted five focus groups with older adults in rural and urban

settings to fulfill the purpose of their study.

“Following approval from a university behavioral research ethics board, five groups of older participants

(>65 years) were purposely selected from across geographical sections in a Western Canadian province Continued

85CHAPTER 3 Introduction to Qualitative Research

Observation Observation is a fundamental method of gathering data for qualitative studies, especially eth-

nography studies. The aim is to gather first-hand information in a naturally occurring situation.

The researcher assumes the role of a learner to answer the question, “What is going on here?” The

activities being observed may be automatic or routine for the participants, who may be unaware

of some of their actions. The researcher looks carefully at the focus of the study, notices people

and objects in the environment, and listens for what is said and unsaid. The researcher focuses on

the details, including discrete events and the process of activities. Unexpected events occurring

during routine activities may be significant and are carefully noted. As in any observation pro-

cess, the qualitative researcher will attend to some aspects of the situation while disregarding

others.

In studies that use observation, notes taken during or shortly after observations are called field

notes. Waiting until the observation is over allows the researcher to focus entirely on the obser-

vational experience to avoid missing something meaningful, but may result in not all pertinent

data being recorded. Another useful strategy is to videotape the events, so that careful observations

and detailed notes can be taken at a later time.

RESEARCH EXAMPLE—cont’d

to reflect its urban but also highly rural landscape. Sample selection sought to maximize variation in the older

adult demographic, important at this exploratory stage in broadly assessing an understanding of strength. . . .

Organized senior groups from rural and urban communities . . . served as the pool from which group partic-

ipants were recruited. . . . Potential participants were invited to participate in a focus group that was sched-

uled in conjunction with one of the senior groups’ monthly meetings and at their regular meeting

location.” Rush et al., 2013, pp. 11-12

“Focus groups were deemed appropriate for this exploratory study in order to obtain a breadth of per-

spectives related to strength. Following consent, participants completed a short demographic form. . . .

A group facilitator used a semistructured interview guide to elicit focus group participants’ perspectives. . . .

A recorder was available to take notes and document observations of participants and their interactions.

Focus groups lasted from 1 to 1½ hours and were digitally recorded.” Rush et al., 2013, p. 12

Critical Appraisal The process of recruitment was described in sufficient detail. Recruiting from pre-existing groups and meeting in the

group’s usual location were convenient and effective methods. However, the researchers noted that participants in

seniors groups reflect the perspectives of persons who are connected to their community and may not reflect the

perspectives of those who are more isolated. Groups were categorized as being rural or urban, depending on the

government designation of rural and urban communities, but some participants who were identified as being urban

based on group location actually considered themselves to be rural. Having a recorder to document observations of

behavior and context strengthened the data collection process. Additional information about informed consent, the

number who did not participate, and the effect of pre-existing relationships among the group members would have

strengthened the study.

Implications for Practice The participants in the study reported that strength was hard to describe and define. The themes were “capacity to

meet variable demands,” “ability to meet everyday ordinary demands,” “reserve capacity to meet episodic extraor-

dinary demands,” and “resilience capacity to meet ongoing, life-changing demands” (Rush et al., 2013, p. 13). The

older adults identified strategies to remain strong as giving support, receiving support, and remaining active in

physical, social, and intellectual activities (p. 14).

86 CHAPTER 3 Introduction to Qualitative Research

Text as a Source of Qualitative Data In qualitative studies, text is considered a rich source of data. During a historical study, the

researchers may examine texts written prior to the study, such as letters, diaries, newspaper

accounts, and written descriptions of events. Other sources of pre-existing text are clinical notes

in a medical record, policy manuals, and newspaper articles. Other texts may be created for the pur-

pose of the study. For example, the researcher may ask participants to write about a particular topic.

In some cases, these written narratives may be solicited by mail or e-mail rather than in person. Text

provided by participants may be a component of a larger study using a variety of sources of data.

? CRITICAL APPRAISAL GUIDELINES Observation

When data were collected through observation, the following questions can be asked to critically appraise the

method:

1. Did the researchers describe when and where the observations occurred? Were the timing and location of the

observations appropriate to address the research question? For example, if the observations occurred in a

hospital, were observations conducted on all shifts and on all days of the week?

2. Did the researchers report the length of time spent observing? Was the time adequate to collect detailed and

comprehensive data?

3. Did the report include information about how the data were recorded? Were field notes used?

RESEARCH EXAMPLE

Observation

Research Study Excerpt In an ethnographic study, data about family presence during weaning from mechanical ventilation were collected by

observation, interviews, and reviewing the providers’ notes (Happ et al., 2007). The researchers dictated or wrote

detailed notes on an observation guide developed during a previous study.

“Observations were conducted by one of the two researchers. . . . 4 to 5 days a week, including evenings and

weekends, with a focus on observing weaning trials. Observations were recorded by dictated or handwritten

field notes. . . . Families’ talk, touch, physical stance, proximity to the patient, movement in the room, atten-

tion to electronic monitors and technologic devices were documented.” Happ et al., 2007, p. 49

Family presence was the overall theme that was identified, comprised of behaviors that included touch, talk, and sur-

veillance.Somebehaviors were interpretedasbeing helpfultotheweaning process whereas others were deemedas inter-

fering with the process. The researchers identified the need for additional studies that could build on these findings.

Critical Appraisal Happ and colleagues (2007) collected data over a 20-month period (201 days) from 30 patients, 41 family members,

and 31 clinicians. The observations occurred when family members were present during weaning of the patient from

the ventilator. The study was funded by a federal grant that supported the labor-intensive process; this allowed a

comprehensive description of a complex phenomenon. The research team had conducted previous studies that

allowed them to refine their methods, increasing the credibility of the study findings.

Implications for Practice A finding in the study conducted by Happ and associates (2007) not found in previous studies was that family mem-

bers can be valuable sources of clinical information about a patient’s condition. Family members’ ability to facilitate

the weaning process and relay helpful information to the staff may be enhanced by respiratory therapists and nurses

who assist family members to interpret monitors and learn comforting behaviors. Congruent with QSEN (2013)

standards, the findings validated the importance of patient-centered, individualized care.

87CHAPTER 3 Introduction to Qualitative Research

DATA MANAGEMENT

Qualitative data analysis occurs concurrently with data collection (Miles, Huberman, & Saldana,

2014), rather than sequentially, as in quantitative research. Therefore the researcher is attempting

to gather, manage, and interpret a growing bulk of data simultaneously, which requires the

researcher to have a plan for naming files and securely storing the data, so that specific data

can be retrieved as needed.

Organizing Data Files Keeping track of connections between various bits of data requires meticulous record keeping and

may be supported by using computer-assisted qualitative data analysis software (CAQDAS) pro-

grams (Miles et al., 2014). The researchers will read, reread, and analyze the data over time to main-

tain a close link with—or become immersed in—the data being analyzed. The software allows the

researcher to write memos about the analysis process and decisions that were reached, and it cre-

ates the audit trail of the study. The limitations on the length of manuscripts for peer-reviewed

journals may prevent the researchers from reporting details of data management. However, having

a general understanding of data management and analysis may provide the background needed to

evaluate study proposals being considered by your facility or IRB.

Experienced researchers often create an organizational plan for the data they will collect as part

of the preparation for the study. Considerations include securing computers, storage devices, and

files to preserve the confidentiality of the data. Some IRBs may require that files be password-

protected. Storing data files in more than one location is recommended to prevent loss of the data

in case a computer crashes or a storage device becomes corrupted.

Transcribing Interviews The most commonly used textual data in qualitative studies are transcripts of recorded interviews

and focus groups. Transcription is at the heart of the qualitative research process, because a “ver-

batim transcript captures participants’ own words, language, and expressions” and allows the

researcher to “decode behavior, processes, and cultural meanings attached to people’s perspec-

tives” (Hennink & Weber, 2013, p. 700). Transcripts from such recordings can result in copious

data for analysis. In a study report, researchers should describe how data were recorded during

the interview, focus group, or observations and the strategies used to ensure the accuracy of

the transcriptions. Typically, transcripts are prepared by typing everything in the recording word

for word by the person speaking. Computer programs are now available which are voice-activated

and can produce a written record of the recording. Even when computer software or a professional

transcriptionist is used, the researcher will ensure accuracy by reading and correcting the transcript

while listening to the recording.

DATA ANALYSIS

Data analysis is a rigorous process. Because published qualitative studies may not contain the

methodology in detail, many professionals believe that qualitative research is a free-wheeling pro-

cess, with little structure. Creativity and deep thought may produce innovative views to analyze the

data, but the process requires discipline to develop data analysis plans consistent with the specific

philosophical method of the study. For example, researchers conducting grounded theory studies

use the constant comparative process by comparing concepts and themes identified through the

analysis with those identified in subsequent data. In grounded theory, the analysis begins with the

first participant interview, so that ideas from that participant can be integrated into questions and

88 CHAPTER 3 Introduction to Qualitative Research

probes in subsequent interviews. In phenomenology, this immersion in the data is referred to as

dwelling with the data. This phrase is used to indicate that the researcher spent considerable time

reading and reflecting on the data.

Codes and Coding Coding is the process of reading the data, breaking text down into subparts, and giving a label to

that part of the text. These labels provide a way for the researcher to begin to identify patterns in the

data, because sections of text that were coded in the same way can be compared for similarities and

differences. A code is a symbol or abbreviation used to classify words or phrases in the data. Codes

may be handwritten on a printed transcript. In a word-processing program or CAQDAS, you code

by highlighting a section of text and making a comment in the margin or sidebar. Codes may result

in themes, processes, or exemplars of the phenomenon being studied. When coding data for a phe-

nomenological study, the researcher will first label shifts in meaning in the flow of the transcript

(Liamputtong, 2009). A grounded theory researcher first labels statements using open codes to

compare the data. In a qualitative study of medication adherence, participants mentioned clocks,

schedules, hours, and doses that the researcher coded as “time.” An exploratory-descriptive qual-

itative study about pain experiences of surgical patients may result in a taxonomy of types of pain,

activities that resulted in pain, and types of pain relief strategies.

Themes and Interpretation Themes emerge as codes that are combined into more abstract phrases or terms. Sometimes there

are several layers of themes, with each layer further from the initial codes. Making links between

these themes and the original data may become more difficult as the themes become more abstract.

The rigor and clarity of the linking are of great importance, and it is the researcher who must

remain rigorous in showing the links from the themes back to the original data. When you read

qualitative studies that have used themes, search for evidence of links back to the original data. If

you are critically appraising a qualitative study that uses themes, identify the themes and determine

whether they seem sufficient and adequate for the study. During interpretation, the researcher

places the findings in a larger context and may link different themes or factors in the findings

to each other. The researcher is answering the question, “What do the findings mean?” Interpre-

tation may focus on the usefulness of the findings for clinical practice or may move toward

theorizing.

? CRITICAL APPRAISAL GUIDELINES Data Analysis and Interpretation in Qualitative Studies

An important part of writing the report of a qualitative study is describing the data collection and analysis process.

To appraise a qualitative study critically, you need to address the following questions:

1. Were the data analysis and interpretation processes consistent with the philosophical orientation and purpose

of the study?

2. Did the researchers describe how they recorded decisions made during analysis and interpretation?

3. Did the researchers link the codes and themes used with exemplar quotations? This allows you to judge

whether the codes were appropriate and adequate for the study.

4. Were the data analysis and interpretation logical and congruent with the study method?

5. Did the researchers provide adequate description of the data analysis and interpretation processes? The

researcher who reports very little about the data collection and analysis process leaves the question of rigor

unanswered.

89CHAPTER 3 Introduction to Qualitative Research

K E Y C O N C E P T S

• Qualitative research is a systematic approach used to elicit oral and written descriptions of life

experiences from the perspective of the participants and give the experiences new meaning.

• Qualitative data are words, instead of numbers.

• Qualitative researchers set aside their own values and experiences to allow the multiple realities

of the persons experiencing a phenomenon to emerge.

• Rigor in qualitative research requires critically appraising the study for congruence with the

philosophical perspective; appropriateness of the collection, analysis, and interpretation of data;

maintenance of an audit trail; and logic of the findings reported in the research report.

• A phenomenological researcher examines an experience and provides interpretations that

enhance the meaning while staying true to the perspective of those who have lived the

experience.

• Grounded theory researchers explore underlying social processes through the symbols of lan-

guage, religion, relationships, and clothing and describe the deeper meaning of an event as a

theoretical framework.

• Ethnographic researchers observe and interview people within a culture to understand the envi-

ronment, people, power relations, and communication patterns of a work setting, community,

or ethnic group.

RESEARCH EXAMPLE

Data Analysis and Interpretation Processes

Research Study Häggström, Asplund, and Kristiansen (2012) thoroughly described the data analysis processes that they used in their

grounded theory study of nurses facilitating patients’ transitions from intensive care units. They initially collected

data with focus groups and the analysis of these data resulted in 10 preliminary categories. To ensure a broad

representation of nurses’ experiences, they used theoretical sampling to identify additional nurses with potentially

different experiences and interviewed them. The flow diagram they included in the study report indicated the

different levels of codes they identified, as is appropriate for grounded theory. The flow diagram also served as doc-

umentation of the analysis and comprised part of the audit trail for the study (p. 227). The core category of “being

perceptive and adjustable” was necessary to achieve the process of “balancing between patient needs and caregiver

resources” (p. 229).

Critical Appraisal Häggström and associates (2012) implemented the data analysis processes of their grounded theory study

consistently with the philosophical approach of the method. They analyzed multiple sources of data (focus groups,

observation, and interviews) collected in two hospitals to provide a rich picture of transitioning patients from inten-

sive care units. In addition to the flow diagram, they provided a detailed table of when each focus group, interview,

and observation occurred and how long it lasted. The report provided ample evidence that the findings emerged

from the data and that the interpretation was consistent with the perspectives of the participants.

Implications for Practice Häggström and co-workers (2012) concluded that individualized plans of care are needed because patients and their

situations are unique. Discharge planning needs to begin at admission and be revised throughout the hospital stay.

They also noted the challenges of meeting patient needs in organizations that are increasingly focused on efficiency,

especially when resources are lacking. Their findings provide support for managers to recognize that providing

patient-centered care, a QSEN (2013) expectation, requires adequate caregiver resources.

90 CHAPTER 3 Introduction to Qualitative Research

• Exploratory-descriptive qualitative studies are conducted to provide information that will pro-

mote understanding of an experience from the perspective of the persons living the experience.

• Historical researchers explore past events by finding and examining documents from that time

to gain insight into causes and factors surrounding the event.

• Data collection in qualitative studies occurs in the context of the relationship between the par-

ticipant and researcher.

• Data in qualitative studies are collected through interviews, focus groups, observation, and

review of documents.

• Data management, analysis, and interpretation require clear procedures to ensure methodolog-

ical rigor and credibility of the findings.

REFERENCES

Ågård, A., Egerod, I., T�nnesen, E., & Lomborg, K. (2012). Struggling for independence: A grounded theory study

on convalescence of ICU survivors 12 months post ICU

discharge. Intensive and Critical Care Nursing, 28,

105–113.

Bloomberg, L., & Volpe, M. (2008). Completing your

qualitative dissertation: A roadmap from beginning to

end. Los Angeles, CA: Sage.

Bolderston, A. (2012). Conducting a research interview.

Journal of Medical Imaging and Radiation Sciences, 43

(1), 66–76.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Chen, P. Y., & Chang, H. -C. (2012). The coping process of

patients with cancer. European Journal of Oncology

Nursing, 16(1), 10–16.

Connolly,C.,&Gibson,M.(2011).The“WhitePlague”and

color: Children, race, and tuberculosis in Virginia

1900–1935.JournalofPediatricNursing,26(3),230–238.

Converse, M. (2012). Philosophy of phenomenology: How

understanding aids research. Nurse Researcher, 20(1),

28–32.

Creswell, J. (2013). Qualitative inquiry and research design:

Choosing among five approaches (3rd ed.). Thousand

Oaks, CA: Sage.

Dowling, M., & Cooney, A. (2012). Research approaches

related to phenomenology: Negotiating a complex

landscape. Nurse Researcher, 20(2), 21–27.

Fenwick, C., Chaboyer, W., & St. John, W. (2012).

Decision-making processes for the self-management of

persistent pain: A grounded theory study.

Contemporary Nurse, 42(1), 53–66.

Flood, A. (2010). Understanding phenomenology. Nurse

Researcher, 17(2), 2–7.

Glaser, B. G., & Strauss, A. (1967). The discovery of

grounded theory: Strategies for qualitative research.

Chicago: Aldine.

Gray, J. (2009). Rooms, recordings, and responsibilities: The

logistics of focus groups. Southern Online Journal of

Nursing Research, 9(1). Retrieved December 30, 2013

from, http://www.resourcenter.net/images/SNRS/Files/

SOJNR_articles2/Vol09Num01Art05.pdf.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis, MO: Elsevier Saunders.

Häggström, M., Asplund, K., & Kristiansen, L. (2012).

How can nurses facilitate patient’s transitions from

intensive care? Intensive and Critical Care Nursing, 28

(4), 224–233.

Happ, M. B., Swigart, V. A., Tate, J. A., Arnold, R. M.,

Sereika, S. M., & Hoffman, L. A. (2007). Family

presence and surveillance during weaning from

prolonged mechanical ventilation. Heart & Lung, 36

(1), 47–57.

Hennink, M., & Weber, M. (2013). Quality issues of court

reporters and transcriptionists for qualitative research.

Qualitative Health Research, 23(5), 700–710.

Houghton, C., Hunter, A., & Meskell, P. (2012). Linking

aims, paradigm and method in nursing research. Nurse

Researcher, 20(2), 34–39.

Knopf, S. A. (1922). A history of the National Tuberculosis

Association. New York: National Tuberculosis

Association.

Leininger, M. M. (Ed.). (1985). Qualitative research

methods. Orlando, FA: Grune and Stratton.

Leininger, M. M. (1988). Leininger’s theory of nursing:

Cultural care diversity and universality. Nursing Science

Quarterly, 1, 152–160.

Leininger, M. M. (2002). Culture care theory: A major

contribution to advance transcultural nursing

knowledge and practices. Journal of Transcultural

Nursing, 13(3), 189–192.

Letourneau, N., Young, C., Secco, L., Stewart, M.,

Hughes, J., & Critchley, K. (2011). Supporting

mothering: Service providers’ perspectives of mothers

91CHAPTER 3 Introduction to Qualitative Research

and young children affected by intimate partner

violence. Research in Nursing & Health, 34(3), 192–203.

Liamputtong, P. (2009). Qualitative research methods (3rd

ed.). South Melbourne, Australia: Oxford University

Press.

MacGregor, C., Hamilton, A., Oishi, S., & Yano, E. (2011).

Description, development, and philosophies of mental

health service delivery for female veterans in the VA: A

qualitativestudy.Women’sHealthIssues,21(4S),S138–S144.

Mapp, T. (2008). Understanding phenomenology: The

lived experience. British Journal of Midwifery, 16(5),

308–311.

Martsolf, D., Draucker, C., Bednarz, L., & Lea, J. (2011).

Listening to the voices of important others: How

adolescents make sense of troubled dating

relationships. Archives of Psychiatric Nursing, 25(6),

430–444.

Maxwell, J. (2014). Qualitative research design: An interactive

approach (3rd ed.). Thousand Oaks, CA: Sage.

McCready, J. (2010). Jamesian pragmatism: A framework

for working toward unified diversity in nursing

knowledge development. Nursing Philosophy, 11(3),

191–203.

McDermott-Levy, R. (2011). Going alone: The lived

experience of female Arab-Muslim nursing students

living and studying in the United States. Nursing

Outlook, 59(5), 266–277.

Mead, G. H. (1934). Mind, self and society. Chicago:

University of Chicago Press.

Miles, M., Huberman, A., & Saldana, J. (2014). Qualitative

data analysis: A methods sourcebook (3rd ed.).

Thousand Oaks, CA: Sage.

Munhall, P. L. (Ed.), (2012). Nursing research: A qualitative

perspective. (5th ed.). Sudbury, MA: Jones & Bartlett.

Norfolk City Union of the King’s Daughters Visiting Nurse

Service. (1907, 1909, 1910). Children’s Hospital of the

King’s Daughters. Norfolk Virginia.

Nowak, E., & Stevens, P. (2011). Vigilance in parents’

experiences of fetal and infant loss. Journal of

Obstetric, Gynecologic, and Neonate Nursing, 40(1),

122–130.

Oliver, C. (2012). The relationship between symbolic

interactionism and interpretive description.

Qualitative Health Research, 22(3), 409–415.

Petty, N., Thomson, O., & Stew, G. (2012). Ready for a

paradigm shift? Part 2: Introducing qualitative research

methodologies and methods. Manual Therapy, 17(5),

378–384.

Ponterotto, J. (2005). Qualitative research in counseling

psychology: A primer on research paradigms and

philosophy of science. Journal of Counseling Psychology,

52(2), 126–136.

Portacolone, E. (2013). The notion of precariousness

among older adults living alone in the U.S. Journal of

Aging Studies, 27(2), 166–174.

Quality and Safety Education for Nurses (QSEN), (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved December 30, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas/.

Roberts, T. (2009). Understanding ethnography. British

Journal of Midwifery, 17(5), 291–294.

Rogers, S. (1917). Mortality statistics for 1915: Sixteenth

annual report. Washington, D.C.: U.S. Government

Printing Office.

Roper, J. M., & Shapiro, J. (2000). Ethnography in nursing

research. Thousand Oaks, CA: Sage.

Rush, K., Watts, W., & Janke, R. (2013). Rural and urban

older adults’ perspectives of strength in their daily lives.

Applied Nursing Research, 26(1), 10–16.

Sadala, M., Stolf, N., Bocchi,E.,& Bicudo, M.(2013). Caring

for heart transplant recipients: The lived experience of

primary caregivers. Heart & Lung, 42(2), 120–125.

Sandelowski, M. (2000). Whatever happened to qualitative

description? Research in Nursing & Health, 423(5),

334–340.

Sandelowski, M. (2010). What’s in a name? Qualitative

description revisited. Research in Nursing & Health, 33

(1), 77–84.

Savage, J. (2006). Ethnographic evidence: The value of

applied ethnography in healthcare. Journal of Research

in Nursing, 11(5), 383–395.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Thompson, M. E., & Keeling, A. A. (2012). Nurses’ role in

the prevention of infant mortality in 1884–1925:

Health disparities then and now. Journal of Pediatric

Nursing, 27(5), 471–478.

Trollvik, A., Nordbach, R., Silen, C., & Ringsberg, K. C.

(2011). Children’s experiences of living with asthma:

Fear of exacerbations and being ostracized. Journal of

Pediatric Nursing, 26(4), 295–303.

Walton, J., Chute, E., & Ball, L. (2011). Negotiating the role

of the professional nurse: The pedagogy of simulation:

A grounded theory study. Journal of Professional

Nursing, 27(5), 299–310.

Wuerst, J. (2012). Grounded theory: The method. In P. L.

Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 225–256). (5th ed.). Sudbury, MA:

Jones & Bartlett.

92 CHAPTER 3 Introduction to Qualitative Research

C H A P T E R

4 Examining Ethics in Nursing Research

C H A P T E R OV E R V I E W

Historical Events Influencing the Development of

Ethical Codes and Regulations, 95

Nazi Medical Experiments, 95

Nuremberg Code, 95

Declaration of Helsinki, 96

Tuskegee Syphilis Study, 97

Willowbrook Study, 97

Jewish Chronic Disease Hospital Study, 97

Department of Health, Education, and Welfare,

1973: Regulations for the Protection of Human

Research Subjects, 98

National Commission for the Protection of

Human Subjects of Biomedical and Behavioral

Research, 98

Current Federal Regulations for the Protection of

Human Subjects, 99

Protecting Human Rights, 100

Right to Self-Determination, 101

Persons with Diminished Autonomy, 101

Right to Privacy, 105

Right to Anonymity and Confidentiality, 106

Right to Fair Selection and Treatment, 107

Right to Protection from Discomfort and

Harm, 108

Critical Appraisal Guidelines to Examine

Protection of Human Rights in Studies, 109

Understanding Informed Consent, 111

Essential Information for Consent, 111

Comprehension of Consent Information, 112

Competence to Give Consent, 112

Voluntary Consent, 113

Documentation of Informed Consent, 113

Critical Appraisal Guidelines to Examine

Informed Consent in Studies, 115

Understanding Institutional Review, 117

Levels of Reviews Conducted by Institutional

Review Boards, 117

Influence of Health Insurance Portability and

Accountability Act Privacy Rule on

Institutional Review Boards, 118

Examining the Benefit-Risk Ratio of a

Study, 119

Critical Appraisal Guidelines for Examining

the Ethical Aspects of Studies, 120

Understanding Research Misconduct, 122

Role of the Office of Research Integrity in

Promoting the Conduct of Ethical

Research, 122

Examining the Use of Animals in

Research, 123

Key Concepts, 125

References, 125

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Identify the historical events influencing the

development of ethical codes and regulations for

nursing and biomedical research.

2. Describe the ethical principles that are

important in conducting research on human

subjects.

93

3. Describe the human rights that require

protection in research.

4. Identify the essential elements of the informed

consent process in research.

5. Describe the role of a nurse in the institutional

review of research in an agency.

6. Examine the benefit-risk ratio of published

studies and studies proposed for conduct in

clinical agencies.

7. Describe the types of possible scientific

misconduct in the conduct, reporting, and

publication of healthcare research.

8. Critically appraise the protection of human

rights and the informed consent and

institutional review processes in published

studies.

9. Critically appraise the treatment of animals

reported in published studies.

K E Y T E R M S

Anonymity, p. 106

Assent to participate in

research, p. 102

Autonomous agents, p. 101

Benefit-risk ratio, p. 119

Breach of confidentiality,

p. 107

Coercion, p. 101

Confidentiality, p. 107

Consent form, p. 112

Covered entities, p. 105

Covert data collection, p. 101

Data use agreement, p. 106

Deception, p. 101

Diminished autonomy, p. 101

Discomfort and harm, p. 108

Ethical principles, p. 98

Principle of beneficence,

p. 98

Principle of justice, p. 98

Principle of respect for

person(s), p. 98

Fabrication in research, p. 122

Falsification of research, p. 122

Health Insurance Portability

and Accountability Act

(HIPAA), p. 99

Human rights, p. 100

Individually identifiable health

information, p. 105

Informed consent, p. 111

Institutional review, p. 117

Complete review, p. 118

Exempt from review, p. 117

Expedited review, p. 118

Institutional review board

(IRB), p. 117

Invasion of privacy, p. 105

Minimal risk, p. 118

Nontherapeutic research,

p. 96

Permission to participate in

research, p. 102

Plagiarism, p. 122

Privacy, p. 105

Research misconduct, p. 122

Therapeutic research, p. 96

Voluntary consent, p. 113

Ethical research is essential for generating sound empirical knowledge for evidence-based practice,

but what does ethical conduct of research involve? This is a question that researchers, philosophers,

lawyers, and politicians have debated for many years. The debate continues, probably because of

the complexity of human rights issues, the focus of research in new and challenging arenas of tech-

nology and genetics, the complex ethical codes and regulations governing research, and the various

interpretations of these codes and regulations. This chapter introduces you to the national and

international codes and regulations developed to promote the ethical conduct of research.

You might think that unethical studies that violate subjects’ rights are a thing of the past, but this

is not the case. There are still situations in which researchers do not protect the subjects’ privacy

adequately or the study participants are treated unfairly or harmed during a study. Another serious

ethical problem that has increased over the last 20 years is research misconduct. Research miscon-

duct includes incidences of fabrication, falsification, or plagiarism in the process of conducting and

reporting research in nursing and other healthcare disciplines (Office of Research Integrity

[ORI], 2013).

You need to be able to appraise the ethical aspects of published studies and of research con-

ducted in clinical agencies critically. Most published studies include ethical information about

94 CHAPTER 4 Examining Ethics in Nursing Research

subject selection and treatment during data collection in the methods section of the report. Insti-

tutional review boards (IRBs) in universities and clinical agencies have been organized to examine

the ethical aspects of studies before they are conducted. Nurses often are members of IRBs and

participate in the review of research for conduct in clinical agencies.

To provide you with a background for examining ethical aspects of studies, this chapter

describes the ethical codes and regulations that currently guide the conduct of biomedical and

behavioral research. The following elements of ethical research are detailed: (1) protecting human

rights; (2) understanding informed consent; (3) understanding institutional review of research;

and (4) examining the balance of benefits and risks in a study. This chapter also provides critical

appraisal guidelines for examining the ethical aspects of studies. The chapter concludes with a dis-

cussion of two additional important ethical issues, research misconduct and the use of animals in

research.

HISTORICAL EVENTS INFLUENCING THE DEVELOPMENT OF ETHICAL CODES AND REGULATIONS

Since the 1940s, four experimental projects have been highly publicized for their unethical

treatment of human subjects: the Nazi medical experiments, the Tuskegee Syphilis Study, the

Willowbrook Study, and the Jewish Chronic Disease Hospital Study (Berger, 1990; Levine,

1986). Although these were biomedical studies and the primary investigators were physicians,

the evidence suggests that nurses understood the nature of the research, identified potential

research subjects, delivered treatments to the subjects, and served as data collectors. These

unethical studies demonstrate the importance of ethical conduct for nurses while they are review-

ing or participating in nursing or biomedical research (Fry, Veatch, & Taylor, 2011; Havens, 2004).

These studies also influenced the formulation of ethical codes and regulations that currently direct

the conduct of research.

Nazi Medical Experiments From 1933 to 1945, the Third Reich in Europe was engaged in atrocious and unethical medical

activities. The programs of the Nazi regime included sterilization, euthanasia, and medical exper-

imentation for the purpose of producing a population of “racially pure” Germans who were des-

tined to rule the world. The medical experiments were conducted on prisoners of war and persons

considered to be racially valueless, such as Jews, who were confined in concentration camps. The

experiments involved exposing subjects to high altitudes, freezing temperatures, malaria, poisons,

spotted fever (typhus), or untested drugs and performing surgical procedures, usually without any

form of anesthesia for the subjects. Extensive examination of the records from some of these stud-

ies indicated that they were poorly conceived and conducted. Therefore this research was not only

unethical but also generated little if any useful scientific knowledge (Berger, 1990; Steinfels &

Levine, 1976).

The Nazi experiments violated numerous rights of the research subjects. The selection of sub-

jects for these studies was racially based and unfair, and the subjects had no choice—they were

prisoners who were forced to participate. As a result of these experiments, subjects frequently were

killed or they sustained permanent physical, mental, and social damage (Levine, 1986).

Nuremberg Code Those involved in the Nazi experiments were brought to trial before the Nuremberg Tribunals, and

their unethical research received international attention. The mistreatment of human subjects in

95CHAPTER 4 Examining Ethics in Nursing Research

these studies led to the development of the Nuremberg Code in 1949. Box 4-1 presents this code.

The code includes guidelines that should help you evaluate the consent process, protection of sub-

jects from harm, and balance of benefits and risks in a study (U.S. Department of Health and

Human Services [U.S. DHHS], Office of Human Research Protection [OHRP], 2013).

Declaration of Helsinki The Nuremberg Code provided the basis for the development of the Declaration of Helsinki, which

was adopted in 1964 and revised most recently in 2008 by the World Medical Association (WMA,

2008). A major focus of the initial document was the differentiation of therapeutic research from

nontherapeutic research. Therapeutic research provides patients with an opportunity to receive

an experimental treatment that might have beneficial results. Nontherapeutic research is con-

ducted to generate knowledge for a discipline; the results of the study might benefit future patients

but probably will not benefit those acting as research participants.

The Declaration of Helsinki includes the following ethical principles: (1) the investigator should

protect the life, health, privacy, and dignity of human subjects; (2) the investigator should exercise

greater care to protect subjects from harm in nontherapeutic research; and (3) the investigator

should conduct research only when the importance of the objective outweighs the inherent risks

and burdens to the subjects. The most recent addition to the Declaration of Helsinki is that

researchers must use extreme caution in studies in which participants receive a placebo or sham

treatment. For example, in studies testing the effectiveness of a drug, the placebo group would

receive a pill with no medication and the experimental group would receive a pill with the drug.

BOX 4-1 THE NUREMBERG CODE

The voluntary consent of the human subject is absolutely essential. . . .

The experiment should be such as to yield fruitful results for the good of society, unprocurable by other

methods or means of study, and not random and unnecessary in nature.

The experiment should be so designed and based on the results of animal experimentation and a knowledge of

the natural history of the disease or other problem under study that the anticipated results will justify the per-

formance of the experiment.

The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

No experiment should be conducted where there is an a priori reason to believe that death or disabling injury

will occur, except, perhaps, in those experiments where the experimental physicians also serve as subjects.

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the

problem to be solved by the experiment.

Proper preparations should be made and adequate facilities provided to protect the experimental subject

against even remote possibilities of injury, disability, or death.

The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and

care should be required through all stages of the experiment of those who conduct or engage in the experiment.

During the course of the experiment the human subject should be at liberty to bring the experiment to an end if

he has reached the physical or mental state where continuation of the experiment seems to him to be

impossible.

During the course of the experiment the scientist in charge must be prepared to terminate the experiment at

any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judg-

ment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the

experimental subject.

From U.S. Department of Health and Human Services, Office of Human Research Protection (OHRP). 2013. The Nuremberg

Code (1949). Retrieved June 9, 2013 from, http://www.hhs.gov/ohrp/archive/nurcode.html.

96 CHAPTER 4 Examining Ethics in Nursing Research

Researchers must provide the participants in the placebo group with access to proven diagnostic

and therapeutic procedures after the study (WMA, 2008). The ethical principles of the Declaration

of Helsinki are available online at http://www.wma.net/en/30publications/10policies/b3. Most

institutions in which clinical research is conducted adopted the Nuremberg Code and Declaration

of Helsinki; however, episodes of unethical research continued to occur in biomedical and behav-

ioral studies.

Tuskegee Syphilis Study In 1932 the U.S. Public Health Service initiated a study of syphilis in African American men in the

small rural town of Tuskegee, Alabama (Rothman, 1982). The study, which continued for 40 years,

was conducted to determine the natural course of syphilis in African American men. Many of the

subjects who consented to participate in the study were not informed about the purpose and pro-

cedures of the research. Some were unaware that they were subjects in a study. By 1936 it was

apparent that the men with syphilis had developed more complications than the men in the control

group. Ten years later the death rate among those with syphilis was twice as high as it was for the

control group. The subjects were examined periodically but were not treated for syphilis, even

when penicillin was determined to be an effective treatment for the disease in the 1940s. Informa-

tion about an effective treatment for syphilis was withheld from the subjects, and deliberate steps

were taken to deprive them of treatment (Brandt, 1978).

Published reports of the Tuskegee Syphilis Study started appearing in 1936, and additional

papers were published every 4 to 6 years. No effort was made to stop the study; in fact, in 1969

the Centers for Disease Control and Prevention (then called the Center for Disease Control)

decided that the study should continue. In 1972, an account of the study in the Washington Star

sparked public outrage; only then did the U.S. Department of Health, Education, and Welfare

(DHEW) stop the study. The study was investigated and found to be ethically unjustified

(Brandt, 1978).

Willowbrook Study From the mid-1950s to the early 1970s, Dr. Saul Krugman conducted research on hepatitis at

Willowbrook, an institution for the mentally retarded in Staten Island, New York (Rothman,

1982). The subjects were children who were deliberately infected with the hepatitis virus. During

the 20-year study, Willowbrook closed its doors to new inmates because of overcrowded condi-

tions. However, the research ward continued to admit new inmates, and parents had to give per-

mission for their child to be in the study to gain admission to the institution.

From the late 1950s to the early 1970s, Krugman’s research team published several articles

describing the study protocol and findings. In 1966 Beecher cited the Willowbrook Study in

the New England Journal of Medicine as an example of unethical research. The investigators

defended injecting the children with the hepatitis virus because they believed that most of the chil-

dren would acquire the infection on admission to the institution. They also stressed the benefits the

subjects received, which were a cleaner environment, better supervision, and a higher nurse-to-

patient ratio on the research ward (Rothman, 1982). Despite the controversy, this unethical study

continued until the early 1970s.

Jewish Chronic Disease Hospital Study Another highly publicized unethical study was conducted at the Jewish Chronic Disease Hospital

in New York in the 1960s. The purpose of this study was to determine patients’ rejection responses

to live cancer cells. A suspension containing live cancer cells that had been generated from human

97CHAPTER 4 Examining Ethics in Nursing Research

cancer tissue was injected into 22 patients (Levine, 1986). Because researchers did not inform these

patients that they were taking part in a study or that the injections they received were live cancer

cells, their rights were not protected. In addition, the study was never presented for review to

the research committee of the Jewish Chronic Disease Hospital, and the physicians caring for

the patients were unaware that the study was being conducted. The physician directing the research

was an employee of the Sloan-Kettering Institute for Cancer Research; there was no indication that

this institution had conducted a review of the research project (Hershey & Miller, 1976). This

unethical study was conducted without the informed consent of the subjects and without institu-

tional review and had the potential to injure, disable, or cause the death of the human subjects. The

study was stopped immediately and steps were taken to ensure proper care for the patients exposed

to the cancer cells and to review all future research to be conducted by this agency.

Department of Health, Education, and Welfare, 1973: Regulations for the Protection of Human Research Subjects The continued conduct of harmful, unethical research from the 1960s to the 1970s made additional

controls necessary. In 1973 the DHEW published its first set of regulations for the protection of

human research subjects. These regulations also provided protection for persons having limited

capacity to consent, such as those who are ill, mentally impaired, or dying (Levine, 1986). Accord-

ing to the DHEW regulations, all research involving human subjects had to undergo full institu-

tional review, which increased the protection of human subjects. However, reviewing all studies

without regard for the degree of risk involved greatly increased the time for study approval and

reduced the number of studies conducted.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Because the DHEWregulations did not resolve the issue of protecting human subjects in research,

the National Commission for the Protection of Human Subjects of Biomedical and Behavioral

Research was formed in 1978. This commission was established by the National Research Act

(Public Law 93-348), which was passed in 1974. The commission identified three ethical princi-

ples relevant to the conduct of research involving human subjects: respect for persons, beneficence,

and justice. The principle of respect for persons indicates that people should be treated as auton-

omous agents, with the right to self-determination and the freedom to participate or not partic-

ipate in research. Those persons with diminished autonomy, such as children, people who are

terminally or mentally ill, and prisoners, are entitled to additional protection. The principle of

beneficence encourages the researcher to do good and “above all, do no harm.” The principle

of justice states that human subjects should be treated fairly in terms of the benefits and the risks

of research. Before it was dissolved in 1978, the commission developed ethical research guidelines

based on these three principles and made recommendations to the U.S. DHHS in the Belmont

Report. (Information on this report and the three ethical principles—respect for persons, benef-

icence, and justice—are available online at http://or.org/pdf/BelmontReport.pdf). Greaney and

colleagues (2012) studied these ethical principles and provided guidelines for applying them in

reviewing and conducting nursing research.

Regretfully, violations of human subjects’ rights continue to occur, as evident in letters written

by the Office of Human Research Protection (http://www.hhs.gov/ohrp/index.html). These viola-

tions include omitting required information from informed consent documents, failing to update

the consent document when additional information was available about potential risks, and

98 CHAPTER 4 Examining Ethics in Nursing Research

beginning data collection prior to having the study approved by the IRB. In December 2011,

the Presidential Commission for the Study of Bioethics Issues released its report, Moral Science:

Protecting Participants in Human Subjects Research, which included recommendations for enhanc-

ing the protection of human subjects.

Current Federal Regulations for the Protection of Human Subjects In response to the recommendations presented in the Belmont Report, the U.S. DHHS developed

a set of federal regulations for the protection of human research subjects in 1981, which have

been revised over the years; the most current regulations were approved in 2009. The 2009 regu-

lations are part of the Code of Federal Regulations (CFR), Title 45, Part 46, Protection of Human

Subjects (U.S. DHHS, 2009). These regulations provide direction for the (1) protection of human

subjects in research, with additional protection for pregnant women, human fetuses, neonates,

children, and prisoners; (2) documentation of informed consent; and (3) implementation of

the IRB process. You can access these regulations online at http://www.hhs.gov/ohrp/policy/

ohrpregulations.pdf.

The DHHS Protection of Human Subjects Regulations (U.S. DHHS, 2009) and the U.S. Food

and Drug Administration (FDA) govern most of the biomedical and behavioral research con-

ducted in the United States. The FDA, within the DHHS, manages CFR Title 21—Food and Drugs,

Part 50, Protection of Human Subjects (FDA, 2012a) and Part 56, Institutional Review Boards

(2012b). The FDA has additional human subject protection regulations that apply to clinical inves-

tigations involving products regulated by the FDA under the federal Food, Drug, and Cosmetic Act

and research that supports applications for research or marketing permits for these products.

These regulations apply to studies of drugs for humans, medical devices for human use, biological

products for human use, human dietary supplements, and electronic products (FDA, 2013; http://

www.fda.gov). Physician and nurse researchers conducting clinical trials to generate new drugs and

refine existing drug treatments must comply with these FDA regulations. Table 4-1 clarifies the

focus of the regulations for the protection of human subjects of the DHHS and FDA.

The DHHS and FDA regulations provide guidelines for the protection of subjects in federally

and privately funded research to ensure their privacy and the confidentiality of the information

obtained through research. With the mechanisms for the electronic access and transfer of individ-

uals’ information, however, the public became concerned about the potential abuses of the health

information of persons in all circumstances, including research projects. Therefore a federal

regulation—the Health Insurance Portability and Accountability Act (HIPAA; Public Law

104-191)—was implemented in 2003 to protect people’s private health information (U.S.

DHHS, 2007a). Table 4-1 clarifies the focus of HIPAA regulations as compared with the DHHS

and FDA regulations (U.S. DHHS, 2007b).

The DHHS developed regulations entitled the Standards for Privacy of Individually Identifiable

Health Information; compliance with these regulations is known as the Privacy Rule (U.S. DHHS,

2007a). The HIPAA Privacy Rule established a category known as protected health information

(PHI), which allows covered entities, such as health plans, healthcare clearinghouses, and health-

care providers that transmit health information, to use or disclose PHI to others only in

certain situations. These are discussed later in this chapter.

The HIPAA Privacy Rule has an impact not only on the healthcare environment, but also on the

research conducted in this environment. A person must provide his or her signed permission, or

authorization, before that person’s PHI can be used or disclosed for research purposes. Researchers

must develop their research projects to comply with the HIPAA Privacy Rule. The DHHS has a

website, HIPAA Privacy Rule: Information for Researchers, which addresses the impact of this rule

99CHAPTER 4 Examining Ethics in Nursing Research

on the informed consent and IRB processes in research and answers common questions about

HIPAA (http://privacyruleandresearch.nih.gov; U.S. DHHS, 2007a). The HIPAA Privacy Rule

has had a negative effect on researchers’ abilities to conduct studies; the Institute of Medicine

and other professional organizations are encouraging lessening the impact or removing research

from the HIPAA regulation (Infectious Diseases Society of America, 2009).

PROTECTING HUMAN RIGHTS

What are human rights? How are these rights protected during research? Human rights are claims

and demands that have been justified in the eyes of an individual or by the consensus of a group of

people. Nurses who critically appraise published studies, review research for conduct in their agen-

cies, or assist with data collection for a study have an ethical responsibility to determine whether

the rights of the research participants are protected. The human rights that require protection in

research are the rights to (1) self-determination, (2) privacy, (3) anonymity and confidentiality, (4)

fair selection and treatment, and (5) protection from discomfort and harm (American Nurses

TABLE 4-1 CLARIFICATION OF THE FOCUS OF FEDERAL REGULATIONS AND IMPACT ON RESEARCH

AREA OF

DISTINCTION HIPAA PRIVACY RULE

U.S. DHHS

PROTECTION OF

HUMAN SUBJECTS

REGULATIONS*

U.S. FDA PROTECTION OF

HUMAN SUBJECTS

REGULATIONS{

Overall

Objective

Establish a federal floor of

privacy protections for most

individually identifiable health

information by establishing

conditions for its use and

disclosure by certain

healthcare providers, health

plans, and healthcare

clearinghouses.

To protect the rights

and welfare of

human subjects

involved in research

conducted or

supported by U.S.

DHHS.

Not specifically a

privacy regulation.

To protect the rights, safety, and

welfare of subjects involved in

clinical investigations

regulated by the FDA.

Not specifically a privacy

regulation.

Applicability Applies to HIPAA-defined

covered entities, regardless of

the source of funding.

Applies to human

subjects’ research

conducted or

supported by U.S.

DHHS and research

with private

funding.

Applies to research involving

products regulated by the

FDA.

Federal support is not

necessary for FDA regulations

to be applicable.

When research subject to FDA

jurisdiction is federally funded,

both the DHHS Protection of

Human Subjects Regulations

and FDA Protection of Human

Subjects Regulations apply.

*Title 45, CFR Part 46. {Title 21 CFR, Parts 50 and 56.

From U.S. Department of Health and Human Services (U.S. DHHS). (2007b). How do other privacy protections interact with

the privacy rule? Retrieved May 29, 2013, from http://privacyruleandresearch.nih.gov/pr_05.asp.

100 CHAPTER 4 Examining Ethics in Nursing Research

Association [ANA], 2001; American Psychological Association [APA], 2010; Fawcett & Garity,

2009; Fowler, 2010; Fry et al., 2011). The ANA Code of Ethics for Nurses (2001) provides nurses

with guidelines for ethical conduct in nursing practice and research. This code focuses on protect-

ing the rights of patients and research participants. Fowler (2010) provides a detailed interpreta-

tion and application of the statements in this code.

Right to Self-Determination The right to self-determination is based on the ethical principle of respect for persons, and it indi-

cates that humans are capable of controlling their own destiny. People should be treated as auton-

omous agents who have the freedom to conduct their lives as they choose, without external

controls. Researchers treat subjects as autonomous agents in a study when they (1) inform them

about the study, (2) allow them to choose whether or not to participate, and (3) allow them to

withdraw from the study at any time, without penalty (ANA, 2001; Banner & Zimmer, 2012;

Greaney et al., 2012).

Violation of the Right to Self-Determination A subject’s right to self-determination can be violated through the use of coercion, covert data

collection, and deception. Coercion occurs when one person intentionally presents an overt threat

of harm or an excessive reward to another to obtain compliance. Some subjects are coerced

(forced) to participate in research because they fear harm or discomfort if they do not participate.

For example, some patients believe that their medical and nursing care will be negatively affected if

they do not agree to be research participants. Others are coerced to participate in studies because

they believe that they cannot refuse the excessive rewards offered, such as large sums of money,

special privileges, or jobs (U.S. DHHS, 2009; Emanuel, 2004; Fry et al., 2011).

With covert data collection, subjects are unaware that research data are being collected

(Reynolds, 1979). For example, in the Jewish Chronic Disease Hospital Study, most of the patients

and their physicians were unaware of the study. The subjects were informed that they were receiv-

ing an injection of cells, but the word cancer was omitted (Beecher, 1966).

The use of deception, the actual misinforming of subjects for research purposes, can also violate

a subject’s right to self-determination (Kelman, 1967). A classic example of deception is seen in the

Milgram study (1963), in which the subjects thought they were administering electric shocks to

another person, but the person was really a professional actor who pretended to feel the shocks.

If deception is used in a study, the research report should indicate how the subjects were deceived,

provide a rationale for the use of deception, and discuss when the subjects were informed of the

actual research activities and the findings (U.S. DHHS, 2009).

Persons with Diminished Autonomy Persons have diminished autonomy when they are vulnerable and less advantaged because of

legal or mental incompetence, terminal illness, or confinement to an institution (U.S. DHHS,

2009; FDA, 2012a). They require additional protection of their right to self-determination

because of their decreased ability or inability to give informed consent. In addition, they are vul-

nerable to coercion and deception. The research report should include justification for the use of

these subjects, and the need for justification increases as the subjects’ risks and vulnerability

increase.

Study participants with legal and mental diminished autonomy. Minors (neonates and chil- dren), pregnant women and fetuses, mentally impaired persons, and unconscious patients are

legally and/or mentally unable to give informed consent. These individuals have diminished

101CHAPTER 4 Examining Ethics in Nursing Research

autonomy because they often lack the ability to comprehend information about a study and/or

make decisions about participating in or withdrawing from the study. They have a range of vul-

nerability, from minimal to absolute. The use of persons with diminished autonomy as research

subjects is more acceptable if the following are true: (1) the research is therapeutic—that is, the

subjects might benefit from the experimental process; (2) researchers are willing to use vulner-

able and nonvulnerable people as subjects; (3) the risk is minimized in the study; and (4) the

consent process is strictly followed to ensure the rights of the prospective subjects (U.S.

DHHS, 2009).

Neonates. A neonate is defined as a newborn and is identified as viable or nonviable on delivery.

Viable neonates are able to survive after delivery, if given the benefit of available medical therapy,

and can independently maintain a heartbeat and respiration. “A nonviable neonate means that a

newborn after delivery, although living, is not viable,” or cannot sustain life (U.S. DHHS, 2009, 45

CFR, Section 46.202). Neonates are extremely vulnerable and require extra protection to determine

whether they should be involved in research. However, viable neonates, neonates of uncertain via-

bility, and nonviable neonates may be involved in research if the following conditions are met: (1)

the study is scientifically appropriate and preclinical and clinical studies have been conducted and

provide data for assessing the potential risks to the neonates; (2) the study provides important

biomedical knowledge, which researchers cannot obtain by other means, and will not add risk

to the neonate; (3) the research holds out the prospect of enhancing the probability of survival

of the neonate; (4) both parents are fully informed about the research during the consent process;

and (5) researchers will have no part in determining the viability of a neonate. In addition, for

nonviable neonates, “the vital functions of the neonate should not be artificially maintained

and the research should not terminate the heartbeat or respiration of the neonate” (U.S.

DHHS, 2009, 45 CFR, Section 46.205).

Children. The laws defining the minor status of a child are statutory and vary from state to

state. Often, a child’s competence to give consent depends on his or her age, with incompetence

being irrefutable up to age 7 years (Broome, 1999; Thompson, 1987). However, by age 7, children

can think in terms of concrete operations and can provide meaningful assent to participation as

research subjects. With advancing age and maturity, the child can play a stronger role in the con-

sent process.

The DHHS regulations require “soliciting the assent of the children (when capable) and the

permission of their parents or guardians. Assent to participate in research means a child’s affir-

mative agreement to participate in research. . . . Permission to participate in research means the agreement of parent(s) or guardian to the participation of their child or ward in research” (U.S.

DHHS, 2009, 45 CFR, Section 46.402). The therapeutic nature of the research and the risks versus

benefits also influence the decision about using children as research subjects. Thompson (1987)

developed a guide for obtaining informed consent based on the child’s level of competence, ther-

apeutic nature of the research, and risks versus benefits. This guide is presented in Table 4-2 and

will assist you in evaluating the ethics of a study that includes children. Box 4-2 presents an exam-

ple of an assent form for children 6 to 12 years of age developed by Broome (1999).

There is an increased need for ethical research with children and adolescents as subjects.

Researchers are being urged to conduct clinical trials with children to determine the effectiveness

of select pharmacological and nonpharmacological treatments for various age groups (Rosato,

2000). Congress enacted the Pediatric Research Equity Act (FDA, 2003) to promote the inclusion

of children and adolescents in clinical research. To achieve this goal, parents must be actively

involved with their children in the research process to promote the increased participation of

young people in research (Hadley, Smith, Gallo, Angst, & Knafl, 2007). It is better to contact

102 CHAPTER 4 Examining Ethics in Nursing Research

children and their parents directly rather than by phone, e-mail, or mail to increase their partic-

ipation. Also, the approval process by an IRB is more complex when conducting research on chil-

dren (Savage & McCarron, 2009). Published studies need to indicate clearly that the child gave

assent and the parents or guardians gave permission before data were collected.

BOX 4-2 SAMPLE ASSENT FORM FOR CHILDREN AGES 6 TO 12 YEARS: PAIN INTERVENTIONS FOR CHILDREN WITH CANCER

Oral Explanation

I am a nurse who would like to know if relaxation, special ways of breathing, and using your mind to think pleas-

ant things help children like you to feel less afraid and feel less hurt when the doctor has to do a bone marrow

aspiration or spinal tap. Today, and the next five times you and your parent come to the clinic, I would like you to

answer some questions about the things in the clinic that scare you. I would also like you to tell me about how

much pain you felt during the bone marrow or spinal tap. In addition, I would like to videotape (take pictures of)

you and your mom and/or dad during the tests. The second time you visit the clinic, I would like to meet with you

and teach you special ways to relax, breathe, and use your mind to imagine pleasant things. Then you can use the

special imagining and breathing during your visits to the clinic. I would ask you and your parents to practice the

things I teach you at home between your visits to the clinic. At any time, you could change your mind and not be

in the study anymore.

To Child

I want to learn special ways to relax, breathe, and imagine.

I want to answer questions about things children may be afraid of when they come to the clinic.

I want to tell you how much pain I feel during the tests I have.

I will let you videotape me while the doctor does the tests (bone marrow aspiration and spinal taps).

If the child says YES, have him or her put an “X” here: __________

If the child says NO, have him or her put an “X” here: __________

Date: _____________________

Child’s signature: ___________________________________________

From Broome, M. E. (1999). Consent (assent) for research with pediatric patients. Seminars in Oncology Nursing,

15(2), 101.

TABLE 4-2 GUIDE TO OBTAINING INFORMED CONSENT*

NONTHERAPEUTIC THERAPEUTIC

PARAMETER MMR-LB MR-LB MR-HB MMR-HB

Child, Incompetent (generally 0-7 yr)

Parents’ consent Necessary Necessary Sufficient* Sufficient

Child’s assent Optional{ Optional{ Optional Optional

Child, Relatively Competent (‡7 yr) Parents’ consent Necessary Necessary Sufficient{ Recommended

Child’s assent Necessary Necessary Sufficient} Sufficient

HB, High benefit; LB, low benefit; MMR, more than minimal risk; MR, minimal risk.

*Based on the relationship between a child’s level of competence, therapeutic nature of the research, and risk versus

benefit. A parent’s refusal can be superseded by the principle that a parent has no power to forbid the saving of a child’s life. {Children making a “deliberate objection” would be precluded from participation by most researchers. { In cases not involving the privacy rights of a “mature minor.”

}In cases involving the privacy rights of a “mature minor.”

103CHAPTER 4 Examining Ethics in Nursing Research

Pregnant women and fetuses. Pregnant women require additional protection in research

because of the presence of the fetus. Federal regulations define pregnancy as encompassing

the period of time from implantation until delivery. “A woman is assumed to be pregnant if

she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until

the results of a pregnancy test are negative or until delivery” (U.S. DHHS, 2009, 45 CFR,

Section 46.202). Research conducted with pregnant women should have the potential to benefit

the woman or fetus directly. If the investigation provides a direct benefit just to the fetus,

researchers need to obtain the consent of the pregnant woman and father. Studies with “pregnant

women should include no inducements to terminate the pregnancy and the researcher should

have no part in any decision to terminate a pregnancy” (U.S. DHHS, 2009, 45 CFR,

Section 46.204).

Persons with mental illness or cognitive impairment. Certain persons, because of mental ill-

ness, cognitive impairment, or a comatose state, are incompetent and incapable of giving informed

consent. Persons are said to be incompetent if, in the judgment of a qualified clinician, they have

those attributes that ordinarily provide the grounds for designating incompetence. Incompetence

can be temporary (e.g., with inebriation), permanent (e.g., with advanced senile dementia), or

subjective or transitory (e.g., with behavior or symptoms of psychosis; Beebe & Smith, 2010;

Simpson, 2010). If a person is judged incompetent and incapable of giving consent, the researcher

must seek approval from the prospective subject and his or her legally authorized representative. A

legally authorized representative is a person or another body authorized under applicable law to

consent on behalf of a prospective subject to the subject’s participation in the research procedure

(s) and must be addressed in the research report (U.S. DHHS, 2009; Rotenberg & Rudnick, 2011).

Terminally ill subjects. Participating in research may carry increased risks, with minimal or no

benefits for terminally ill subjects. In addition, the dying subject’s condition potentially may affect

the study results, leading researchers to misinterpret the findings. Cancer patients are an example

of an overstudied population. It is not unusual for several of the procedures performed on cancer

patients to be a result of research protocols that include blood work, bone marrow aspirations,

body scans, lumbar punctures, and biopsies. These biomedical research treatments can easily com-

promise the care of these patients, which poses ethical dilemmas for clinical nurses. Nurses are

responsible for ensuring adherence to ethical standards in research as they participate in an insti-

tutional review of research and serve as patient advocates in clinical settings (ANA, 2001; U.S.

DHHS, 2009; Fowler, 2010).

Persons confined to institutions. Prisoners are people who are confined to institutions and are

designated as having diminished autonomy by federal law (U.S. DHHS, 2009). Prison inmates may

feel coerced to participate in research because they fear harm or desire the benefits of early release,

special treatment, or monetary gain.

Hospitalized patients are also a vulnerable population but are not designated as having dimin-

ished autonomy by law. Patients are vulnerable because they are ill and are confined in settings

controlled by healthcare personnel. Some hospitalized patients feel obligated to be research par-

ticipants because they want to assist a particular nurse or physician with his or her research. Others

feel coerced to participate because they fear that their care will be adversely affected if they refuse.

In their study report, researchers need to document that the rights of patients were protected

during the study.

104 CHAPTER 4 Examining Ethics in Nursing Research

Right to Privacy Privacy is the freedom people have to determine the time, extent, and general circumstances under

which their private information will be shared with or withheld from others. Private information

includes a person’s attitudes, beliefs, behaviors, opinions, and records. The research subject’s pri-

vacy is protected if the subject is informed, consents to participate in a study, and voluntarily shares

private information with a researcher. An invasion of privacy occurs when private information is

shared without a person’s knowledge or against his or her will. The invasion of subjects’ right to

privacy brought about the Privacy Act of 1974. Because of this act, people now have the right to

provide or prevent access of others to their records. A research report often will indicate that the

subjects’ privacy was protected and may include the details of how this was accomplished.

The HIPAA Privacy Rule expanded the protection of a person’s privacy—specifically, his or her

protected, individually identifiable health information—and described how covered entities can use

or disclose this information. Covered entities are healthcare providers, health plans, employers, and

healthcare clearinghouses (public or private entities that process or facilitate the processing of health

information). Individually identifiable health information (IIHI) means that:

. . . any information, including demographic information collected from an individual that is created or received by a healthcare provider, health plan, or healthcare clearinghouse; and

related to past, present, or future physical or mental health or condition of an individual,

the provision of health care to an individual, or the past, present, or future payment for the pro-

vision of health care to an individual, and identifies the individual; or with respect to which there

is a reasonable basis to believe that the information can be used to identify the individual.

U.S. DHHS, 2007a, 45 CFR, Section 160.103

According to the HIPAA Privacy Rule, the IIHI is protected health information (PHI) trans-

mitted by electronic media, maintained in electronic media, or transmitted or maintained in

any other form or medium. The HIPAA privacy regulations affect nursing research in the following

areas (U.S. DHHS, 2007a; Olsen, 2003; Stone 2003):

1. Accessing data from a covered entity, such as reviewing a patient’s medical record in clinics or

hospitals.

2. Developing health information, such as the data developed when an intervention is imple-

mented in a study to improve a subject’s health.

3. Disclosing data from a study to a colleague in another institution, such as sharing data from a

study to facilitate development of an instrument or scale.

The DHHS developed guidelines to assist researchers, healthcare organizations, and healthcare

providers in determining when they can use and disclose IIHI. IIHI can be used or disclosed to a

researcher in the following situations (U.S. DHHS, 2007a):

• The protected health information (PHI) has been de-identified under the HIPAA Privacy Rule.

• The data are part of a limited data set, and a data use agreement with the researcher(s) is in place.

• The person who is a potential subject for a study provides authorization for the researcher to use

and disclose his or her PHI.

• Awaiveror alteration of the authorization requirement isobtained fromanIRB or privacyboard.

The first two items are discussed in this section of the text. The section “Understanding

Informed Consent” discusses the authorization process, and the section “Understanding Institu-

tional Review” covers the waiver or alteration of authorization requirement.

105CHAPTER 4 Examining Ethics in Nursing Research

De-Identifying Protected Health Information under the Privacy Rule

Covered entities, such as healthcare providers and agencies, can allow researchers access to health

information if the information has been de-identified. De-identifying health data involves remov-

ing the elements that could identify a specific person or that person’s relatives, employer, or house-

hold members. You need to be aware of these elements to ensure that a patient’s PHI is kept

confidential in the healthcare agencies in which you work or are a student. The elements that

require de-identifying are (U.S. DHHS, 2007a):

• Names

• All geographic subdivisions smaller than a state, including street address, city, county, precinct,

ZIP code, and their equivalent geographic codes, except for the initial three digits of a ZIP code

• All elements of dates (except year) for dates directly related to an individual, including birth

date, admission date, discharge date, date of death, and all ages over 89 years and all elements

of dates (including year) indicative of such age, except that such ages and elements may be

aggregated into a single category of age 90 years or older

• Telephone numbers

• Facsimile numbers

• Electronic mail (e-mail) addresses

• Social Security numbers

• Medical record numbers

• Health plan beneficiary numbers

• Account numbers

• Certificate and/or license numbers

• Vehicle identifiers and serial numbers, including license plate numbers

• Device identifiers and serial numbers

• Web universal resource locators (URLs)

• Internet protocol (IP) address numbers

• Biometric identifiers, including fingerprints and voiceprints

• Full-face photographic images and any comparable images

• Any other unique identifying number, characteristic, or code, unless otherwise permitted by the

Privacy Rule for re-identification

A person’s health information also can be de-identified using statistical methods. However, the

covered entity and researcher must ensure that the individual subject cannot be identified, or that

there is a very small risk that the subject could be identified from the information collected. The sta-

tisticalmethodusedforde-identificationofthehealthdatamustbedocumented,andthestudymust

certify thattheelementsfor identification have been removed or revised to preventidentification of a

specific person. This certification information must be kept for a period of 6 years by the researcher.

Limited Data Set and Data Use Agreement Covered entities—healthcare provider, health plan, and healthcare clearinghouse—may use and

disclose a limited data set to a researcher for a study without an individual subject’s authorization

or IRB waiver. However, a limited data set is considered PHI, and the covered entity and researcher

need to have a data use agreement. The data use agreement limits how the data set may be used

and how it will be protected.

Right to Anonymity and Confidentiality On the basis of the right to privacy, the research subject has the right to anonymity and the right to

assume that the data collected will be kept confidential. Complete anonymity exists when the

106 CHAPTER 4 Examining Ethics in Nursing Research

subject’s identity cannot be linked, even by the researcher, with his or her individual responses

(Grove, Burns, & Gray, 2013). In most studies, researchers know the identity of their subjects,

and they promise the subjects that their identity will be kept anonymously from others and that

the research data will be kept confidential. Confidentiality is the researcher’s safe management of

information or data shared by a subject to ensure that the data are kept private from others. The

researcher must refrain from sharing this information without the authorization of the subject.

Confidentiality is grounded in the following premises (ANA, 2001; Fowler, 2010):

1. Individuals can share personal information to the extent that they wish and are entitled to have

secrets.

2. One can choose with whom to share personal information.

3. Those accepting information in confidence have an obligation to maintain confidentiality.

4. Professionals, such as researchers and nurses, have a duty to maintain confidentiality that goes

beyond ordinary loyalty.

A breach of confidentiality can occur when a researcher, by accident or direct action, allows

an unauthorized person to gain access to the raw data of a study. Confidentiality also can be

breached in reporting or publishing a study if a participant’s identity is accidentally revealed,

violating his or her right to anonymity. Breach of confidentiality is of special concern in qual-

itative studies that have few study participants and involve the reporting of long quotes made by

those participants. In addition, qualitative researchers and participants often have relationships

in which detailed stories of the participants’ lives are shared, requiring careful management of

study data to ensure confidentiality (Eide & Kahn, 2008; Munhall, 2012a). Breaches of confiden-

tiality that can be especially harmful to participants include those regarding religious preferences,

sexual practices, income, racial prejudices, drug use, child abuse, and personal attributes, such as

intelligence, honesty, and courage. Research reports need to be examined closely for evidence that

the participants’ confidentiality was maintained during data collection, analysis, and reporting

(Munhall, 2012a; Sandelowski, 1994). In addition, the research findings in a published study

should be reported so that a participant or group of participants cannot be identified by their

responses.

Right to Fair Selection and Treatment The right to fair selection and treatment is based on the ethical principle of justice. According to

this principle, people must be treated fairly and receive what they are owed or is comparable to

other persons in the same situation. The research report needs to indicate that the selection of

subjects and their treatment during the study were fair.

Fair Selection and Treatment of Subjects

Injustices in subject selection have resulted from social, cultural, racial, and sexual biases in soci-

ety. For many years, research was conducted on categories of people who were thought to be espe-

cially suitable as research subjects, such as those living in poverty, charity patients, prisoners,

slaves, peasants, dying persons, and others who were considered undesirable (Reynolds, 1979).

Researchers often treated these subjects carelessly and had little regard for the harm and discom-

fort they experienced. The Nazi medical experiments, Tuskegee Syphilis Study, Willowbrook

Study, and Jewish Chronic Disease Hospital Study all exemplify unfair subject selection

(Levine, 1986).

Another concern with subject selection is that some researchers select subjects because they

like them and want them to receive the specific benefits of a study. Other researchers have been

swayed by power or money to make certain patients subjects so that these patients can receive

107CHAPTER 4 Examining Ethics in Nursing Research

potentially beneficial treatments. Random selection of subjects can eliminate some of the

researchers’ biases that may influence subject selection and strengthens the design of the study

(see Chapter 9).

Each study must include a specific researcher-subject agreement or consent form regarding the

researcher’s role and subject’s participation in a study (U.S. DHHS, 2009; FDA, 2012a). While con-

ducting the study, the researcher must treat subjects fairly and respect that agreement. For example,

the activities or procedures that subjects are to perform should not be changed without the

subjects’ and IRB’s consent. The benefits promised to the subjects should be provided. Also,

subjects who participate in studies should receive equal benefits regardless of age, race, or

socioeconomic level.

The research report needs to indicate that the selection and treatment of the subjects were fair.

Subjects must have been selected for reasons directly related to the problem being studied and not

for their easy availability, compromised position, manipulability, or friendship with the researcher

(Greaney et al., 2012; National Commission for the Protection of Human Subjects of Biomedical

and Behavioral Research, 1978). In addition, the procedures section of the research report must

indicate fair and equal treatment of the subjects during data collection (Fawcett & Garity, 2009).

Right to Protection from Discomfort and Harm The right to protection from discomfort and harm in a study is based on the ethical principle of

beneficence, which states that one should do good and, above all, do no harm. According to this

principle, members of society must take an active role in preventing discomfort and harm and

promoting good in the world around them (ANA, 2001, APA, 2010). In research, discomfort

and harm can be physical, emotional, social, or economic or any combination of these four

(Weijer, 2000). Reynolds (1972) identified five categories of studies based on levels of discomfort

and harm—no anticipated effects, temporary discomfort, unusual levels of temporary discomfort,

risk of permanent damage, and certainty of permanent damage.

No Anticipated Effects No positive or negative effects are expected for the subjects in some studies. For example, studies

that involve reviewing patients’ records, students’ files, pathology reports, or other documents

have no anticipated effects on the research subjects. These studies involve no direct interaction

between the researchers and subjects. However, there is still a potential risk of invading a subject’s

privacy. A subject’s IIHI must be protected during data collection and analysis and in publication

of the final report for the study to be compliant with the HIPAA regulations (U.S. DHHS,

2007a, 2009).

Temporary Discomfort Studies that cause temporary discomfort are described as minimal-risk studies, in which the dis-

comfort is similar to what the subject would encounter in his or her daily life and is temporary,

ending with termination of the experiment (U.S. DHHS, 2009). Many nursing studies require the

completion of questionnaires or participation in interviews, which usually involve minimal risk or

are a mere inconvenience for the subjects. The physical discomfort may include fatigue, headache,

or muscle tension. The emotional and social risks may include anxiety or embarrassment associ-

ated with answering certain questions. The economic risks may include the time commitment for

the study or travel costs to the study site.

Most clinical nursing studies examining the effect of a treatment involve minimal risk. For

example, a study may involve examining the effects of exercise on the blood glucose levels of

108 CHAPTER 4 Examining Ethics in Nursing Research

diabetic subjects. For the study, the subjects are asked to test their blood glucose level one extra

time per day. Discomfort occurs when the blood is obtained, and there is a potential risk of physical

changes that may occur with exercise. The subjects may also feel anxiety and fear associated with

the additional blood testing, and the testing may be an added expense. The diabetic subjects in this

study will encounter similar discomforts in their daily lives, however, and the discomfort will cease

with the termination of the study.

Unusual Levels of Temporary Discomfort In studies that involve unusual levels of temporary discomfort, subjects frequently have discomfort

during the study and after they have completed it. For example, subjects may have prolonged mus-

cle weakness, joint pain, and dizziness after participating in a study that required them to be con-

fined to bed for 7 days to determine the effects of immobility. Studies that require subjects to

experience failure, extreme fear, or threats to their identity or to act in unnatural ways involve

unusual levels of temporary discomfort. In some qualitative studies, researchers ask participants

questions that open old wounds or involve reliving a traumatic event (Eide & Kahn, 2008; Fawcett

& Garity, 2009). For example, asking participants to describe their sexual assault experience could

precipitate feelings of extreme anger, fear, or sadness or any combination of these emotions. In

such studies, the IRB protocol is required to include information on the resources to which

researchers can refer subjects who have difficulties. Investigators need to indicate in the research

report that they were vigilant in assessing the participants’ discomfort and referred them as nec-

essary for appropriate professional intervention.

Risk of Permanent Damage In some studies, the possibility exists for subjects to sustain permanent damage; this is more com-

mon in biomedical research than in nursing research. For example, new drugs and surgical pro-

cedures being tested in medical studies have the potential to cause subjects permanent physical

damage. Some topics investigated by nurses have the potential to cause permanent damage to sub-

jects, emotionally and socially. Studies examining sensitive information, such as sexual behavior,

child abuse, HIV-AIDS status, or drug use, can be very risky for subjects. These studies have the

potential to cause permanent damage to a subject’s personality or reputation. There also are poten-

tial economic risks, such as those resulting from a decrease in job performance or loss of

employment.

Certainty of Permanent Damage In some research, such as the Nazi medical experiments and the Tuskegee Syphilis Study, the

subjects have a certainty of experiencing permanent damage. Conducting research that has a

certainty of causing permanent damage to study subjects is highly questionable, regardless of

the benefits that will be gained. Frequently, the benefits gained from such a study are experienced

not by the research participants, but by others in society. Studies causing permanent damage to

subjects violate the fifth principle of the Nuremberg Code and probably should not be conducted

(see Box 4-1).

Critical Appraisal Guidelines to Examine Protection of Human Rights in Studies The human rights that require protection in research include the rights to (1) self-determination,

(2) privacy, (3) confidentiality, (4) fair selection and treatment, and (5) protection from discom-

fort and harm. The guidelines that follow will assist you in critically appraising a study to ensure

the protection of human rights.

109CHAPTER 4 Examining Ethics in Nursing Research

? CRITICAL APPRAISAL GUIDELINES Protection of Human Rights

When critically appraising studies, evaluate whether the participants’ human rights are protected by asking ques-

tions such as the following:

1. Did the study participants or subjects have diminished autonomy because of legal or mental incompetence,

terminal illness, or confinement to an institution? If they did, were special precautions taken in obtaining con-

sent from these participants and their parents or guardians (U.S. DHHS, 2009)?

2. Were the participants’ right to privacy protected and confidentiality of research data maintained during data

collection, analysis, and reporting?

3. Was the individually identifiable health information protected in compliance with the HIPAA Privacy Rule (U.S.

DHHS, 2007a)?

4. Were the participants selected in a fair way for the study?

5. Were the participants treated in a fair way during the conduct of the study?

6. Were the participants protected from discomfort or harm (U.S. DHHS, 2009; FDA, 2012a)?

RESEARCH EXAMPLE

Ethical Conduct of Research with Children and Adolescents

Research Study Excerpt Cerdan, Alpert, Moonie, Cyrkiel, and Rue (2012) conducted a correlational study to examine the relationships of

children and adolescents’ asthma severity and sociodemographic factors with parents’ quality of life (QOL). The

ethical aspects of the study are described in the following excerpt; the human rights protected are identified in

brackets.

Research Design and Methodology “This correlational study utilized a convenience sample of parents of children and adolescents, aged 7 to

17 years, with medical diagnoses of mild intermittent to severe persistent asthma. This study was reviewed

and approved by the institutional review board [IRB] at the University of Nevada, Las Vegas [IRB

approval]. . . . Parents surveyed were legal guardians of the asthmatic children. . . . The clinic was chosen

by the investigators because the clinic had patients with a greater variety of asthma severity (mild, moderate,

or severe) and sociodemographic factors (e.g., health insurance coverage, parental age and ethnicity, and

other variables) [right to fair selection]. . . .

One of the researchers reviewed the charts of all scheduled patients to verify asthma diagnosis and age.

Those deemed to be eligible to participate were approached in the waiting room by the researcher as patients

and parents came in for their scheduled appointments. All potential participants were told that the researcher

was not an employee of the clinic. They were also told that their participation was voluntary and declining

participation would not jeopardize their relationships with their doctor or office staff [right to self-

determination and protection from discomfort or harm]. Those who agreed to participate completed the

informed consent and their children offered assent [right to self-determination and informed consent]. . . .

Prior to completing the three questionnaires, the researcher gave parents explicit instructions on how to

answer the items for each questionnaire, including the option not to answer questions that made them feel

uncomfortable [right to fair treatment]. . . . To maintain participant confidentiality, participant questionnaires

were assigned numbers, and participant names or any other identifying information such as address, tele-

phone number, or birth date were not recorded. The parents returned the questionnaires to the researcher

in unmarked manila envelope to further ensure confidentiality” [right to anonymity, confidentiality, and pri-

vacy; compliance with HIPAA]. Cerdan et al., 2012, pp.132-133

110 CHAPTER 4 Examining Ethics in Nursing Research

UNDERSTANDING INFORMED CONSENT

What is informed consent? How is informed consent obtained from research subjects and docu-

mented in the research report? Informing is the transmission of essential ideas and content from the

investigator to the prospective subject. Consent is the prospective subject’s agreement to participate

in a study as a subject. Every prospective subject, to the degree that he or she is capable, should have

the opportunity to choose whether to participate in research (U.S. DHHS, 2009; FDA, 2012a).

Informed consent includes four elements: (1) disclosure of essential study information to the

study participant; (2) comprehension of this information by the participant; (3) competence of

the participant to give consent; and (4) voluntary consent of the participant to take part in

the study.

Essential Information for Consent Informed consent requires the researcher to disclose specific information to all prospective sub-

jects. The following information is essential for obtaining informed consent from research subjects

(U.S. DHHS, 2009; FDA, 2012a):

1. Introduction of research activities. The initial information presented to prospective subjects

clearly indicates that a study is to be conducted and that they are being asked to participate

as subjects.

2. Statement of the research purpose. The researcher states the immediate purpose of the research

and any long-range goals related to the study.

3. Selection of research subjects. The researcher explains to prospective subjects why they were

selected to participate in the study.

4. Explanation of procedures. Prospective subjects receive a complete description of the proce-

dures to be followed and any procedures that are experimental in the study are identified.

Critical Appraisal Cerdan and associates (2012) clearly described their sampling process, which indicated a fair selection of study par-

ticipants who reflected diversity in asthma severity, parental and child age and ethnicity, and insurance status. The

researchers also recognized that these children and adolescents have diminished autonomy because they are younger

than the adult age of 18 years. The study was explained to the children and adolescents and their parents (legal

guardian), and assent was obtained from the children and adolescents and consent from the parents to participate

in the study. The study participants were identified with numbers, and all other identifying information was not

recorded to ensure confidentiality and privacy of information according to HIPAA U.S. DHHS 2009 regulations.

The children, adolescents, and their parents’ rights to self-determination, privacy, confidentiality, fair selection

and treatment, and protection from discomfort and harm were protected by the informed consent process and

the ethical conduct of this study, according to federal regulations (U.S. DHHS, 2007a, 2009).

Implications for Practice The study findings of Cerdan and co-workers (2012) were consistent with previous research, which indicated that a

number of factors, such as asthma severity and sociodemographic factors, influenced the parents’ QOL. Programs

are needed to take into consideration the parents and their experiences when their children have asthma. Nurses

working with families of asthmatic children need to educate children and parents aggressively and vigilantly monitor

their health status to improve their health outcomes. Quality and Safety Education for Nurses (QSEN) implications

are focused on the competencies of providing evidence-based, safe, and patient- and family-centered care (QSEN,

2013; Sherwood & Barnsteiner, 2012).

111CHAPTER 4 Examining Ethics in Nursing Research

5. Description of risks and discomforts. Prospective subjects are informed of any reasonably fore-

seeable risks or discomforts (physical, emotional, social, and economic) that might result from

the study.

6. Description of benefits. The investigator describes any benefits to the subjects or to other people

or future patients that may reasonably be expected from the research, including any financial

advantages or other rewards for participating in the study.

7. Disclosure of alternatives. The investigator discloses the appropriate alternative procedures or

courses of treatment, if any, that might be advantageous to the subjects (U.S. DHHS, 2009;

FDA, 2012a). For example, the researchers in the Tuskegee Syphilis Study should have

informed the subjects with syphilis that penicillin was an effective treatment for the disease.

8. Assurance of anonymity and confidentiality. Prospective subjects should know the extent to

which their responses and records will be kept confidential. Subjects are promised that their

identity will remain anonymous in presentations and publication of the study.

9. Offering to answer questions. The researcher offers to answer any questions that the prospective

subjects may have.

10. Voluntary participation. The consent form includes a statement that participation is voluntary

and that refusal to participate will involve no penalty or loss of benefits to which the subject is

otherwise entitled.

11. Option to withdraw. Subjects are informed that they may discontinue participation (withdraw

from a study) at any time, without penalty or loss of benefits.

12. Consent to incomplete disclosure. In some studies, subjects are not completely informed of the

study purpose because that knowledge would alter their actions. However, prospective subjects

must be told when certain information is being withheld deliberately.

A consent form is a written document that includes the elements of informed consent required

by U.S. DHHS (2009) and FDA (2012a) regulations. In addition, a consent form may include other

information required by the institution in which the study is to be conducted or by the agency

funding the study. An example of a consent form is presented in Figure 4-1. The boldface terms

indicate the essential consent information.

Comprehension of Consent Information Informed consent implies not only that the researcher has imparted information to the subjects,

but also that the prospective subjects have comprehended that information. The researcher must

take the time to teach the subjects about the study. The amount of information to be taught

depends on the subjects’ knowledge of research and the specific research topic. Researchers need

to discuss the benefits and risks of a study in detail, with examples that the potential subjects or

participants can understand. Nurses often serve as patient advocates in clinical agencies and need

to assess whether patients involved in research understand the purpose and potential risks and

benefits of their participation in a study (ANA, 2001; Banner & Zimmer, 2012; Fry et al., 2011).

Competence to Give Consent Autonomous persons, who are capable of understanding the benefits and risks of a proposed study,

are competent to give consent. Persons with diminished autonomy because of legal or mental

incompetence or confinement to an institution frequently are not legally competent to consent

to participate in research (see earlier, “Right to Self-Determination”). In the research report, inves-

tigators need to indicate the competence of the subjects and the process that was used for obtaining

informed consent (Banner & Zimmer 2012; U.S. DHHS, 2009; FDA, 2012a).

112 CHAPTER 4 Examining Ethics in Nursing Research

Voluntary Consent Voluntary consent means that the prospective subject has decided to take part in a study of his or

her own volition, without coercion or any undue influence (U.S. DHHS, 2009). Researchers obtain

voluntary consent after the prospective subject receives the essential information about the study

and has demonstrated comprehension of this information. All these elements of informed consent

need to be documented in a consent form and discussed in the research report.

Documentation of Informed Consent The documentation of informed consent depends on (1) the level of risk involved in the study and

(2) the discretion of the researcher and those reviewing the study for institutional approval. Most

studies require a written consent form that the subject signs, although in some studies, the require-

ment for written consent is waived. Nurses may be asked to identify subjects for studies, obtain

consent forms for studies, collect study data, or participate in an IRB to review the ethics of a study.

As a result, you need to be aware of the process for documenting informed consent in research.

Ms. Norris is a registered nurse studying the emotional and social needs of family members of patients in the Intensive Care Units (research purpose). Although the study will not benefit you directly, it will provide information that might enable nurses to identify family members’ needs and to assist family members with those needs (potential benefits).

The study and its procedures have been approved by the appropriate people and review boards at The University of Texas at Arlington and X hospital (IRB approval). The study procedures might cause fatigue for you or your family (potential risks). The procedures include: (1) responding to a questionnaire about the needs of family members of critically ill patients and (2) completing a demographic data sheet (explanation of procedures). Participation in this study will take approximately 20 minutes (time commitment). You are free to ask any questions about the study or about being a subject and you may call Ms. Norris at (999) 999-9999 (work) or (999) 999-9999 (disposable cell phone) if you have further questions (offer to answer questions).

Your participation in this study is voluntary; you are under no obligation to participate (alternative option and voluntary consent). You have the right to withdraw at any time and the care of your family member and your relationship with the healthcare team will not be affected (option to withdraw).

The study data will be coded so they will not be linked to your name. Your identity will not be revealed while the study is being conducted or when the study is reported or published. All study data will be collected by Ms. Norris, stored in a secure place, and not shared with any other person without your permission (assurance of anonymity and confidentiality).

I have read this consent form and voluntarily consent to participate in this study.

I have explained this study to the above subject and have sought his/her understanding for informed consent.

Subject’s Signature Date

Investigator’s Signature Date

Legal Representative Date

(If Appropriate)

Study title: The Needs of Family Members of Critically Ill Adults Investigator: Linda L. Norris, R.N.

FIG 4-1 Sample Consent Form. Words in parentheses and boldface identify common essential consent information and would not appear in an actual consent form.

113CHAPTER 4 Examining Ethics in Nursing Research

Written Signed Consent Waived

The requirements for written signed consent may be waived in research that “presents no

more than minimal risk of harm to subjects and involves no procedures for which written consent

is normally required outside of the research context” (U.S. DHHS, 2009, 45 CFR, Section 46.117c).

For example, researchers using questionnaires to collect relatively harmless data do not require a

signed consent form from the subjects. Therefore, the subjects’ completion of the questionnaire

online or through the mail may serve as consent. The top of the questionnaire might contain a

statement such as, “Your completion of this questionnaire indicates your consent to participate

in this study.”

Written signed consent also is waived in a situation in which “the only record linking the subject

and the research would be the consent document and the principal risk would be potential harm

resulting from a breach of confidentiality. Each subject will be asked whether he or she wants doc-

umentation linking them with the research, and the subject’s wishes will govern” (U.S. DHHS,

2009, 45 CFR, Section 46.117c). In this situation, subjects are given the option to sign or not sign

a consent form that links them to the research. The four elements of consent—disclosure, com-

prehension, competency, and voluntariness—are essential in all studies, whether written signed

consent is waived or required.

Written Short Form Consent Documents

The short form consent document includes the following statement: “The elements of informed

consent required by Section 46.116 (see earlier, “Essential Information for Consent”) have been

presented orally to the subject or the subject’s legally authorized representative” (U.S. DHHS,

2009, 45 CFR, Section 46.117a). The researcher must develop a written summary of what is to

be said to the subject in the oral presentation, and an IRB must approve the summary. When

the researcher makes the oral presentation to the subject or to the subject’s representative, a witness

is required. The subject or representative must sign the short form consent document. “The wit-

ness shall sign both the short form and a copy of the summary, and the person actually obtaining

consent shall sign a copy of the summary” (U.S. DHHS, 2009, 45 CFR, Section 46.117a). Copies of

the summary and short form are given to the subject and witness, and the researcher retains the

original documents. The researcher must keep these documents for 3 years. The short form written

consent documents typically are used in studies that present minimal or moderate risk to the

subjects.

Formal Written Consent Document The formal written consent document includes the elements of informed consent required by U.S.

DHHS (2009) and FDA (2012a) regulations (see earlier, “Essential Information for Consent”). The

consent form can be read by the subject or read to the subject by the researcher; however, it is also

prudent to explain the study to the subject. The form is signed by the subject and witnessed by the

investigator or research assistant collecting the data (see example consent form in Figure 4-1). This

type of consent can be used for any type of study, from minimal risk to high risk. All persons sign-

ing the consent form—including the subject, researcher, and any witnesses—must receive a copy of

it. The original consent form is kept by the researcher for a period of 3 years.

Studies that involve subjects with diminished autonomy require a written signed consent form.

If these prospective subjects have some comprehension of the study and agree to participate as

subjects, they must sign the consent form. However, the subject’s legally authorized representative

must sign the form. The representative indicates his or her relationship with the subject under the

signature (see Figure 4-1). Sometimes nurses are asked to sign a consent form as a witness for a

114 CHAPTER 4 Examining Ethics in Nursing Research

biomedical study. They must know the study purpose and procedures and the subject’s compre-

hension of the study before signing the form. To ensure the consistent implementation of the

consent process, nurses and others involved in the consent process are educated about the study

and consent process. Larson, Cohn, Meyer, and Boden-Albala (2009) identified problems with

the lack of standardization of the informed consent process in health-related studies that leads

to disparities in those participating in studies. Certain individuals elect not to participate in

research because of the way the study is presented to them during the consent process. Larson

and co-workers (2009, p. 95) recommended a formal educational program for researchers and

those involved in the consent process “to reduce disparities in research participation by improving

communication between research staff and potential participants.”

Health Insurance Portability and Accountability Act Privacy Rule: Authorization for Research Uses and Disclosure The HIPAA Privacy Rule provides people, as research subjects, with the right to authorize covered

entities (healthcare provider, health plan, and healthcare clearinghouse) to use or disclose their

PHI for research purposes (U.S. DHHS, 2007a). HIPAA regulates this authorization in addition

to the informed consent process regulated by the U.S. DHHS (2009) and FDA (2012a). The autho-

rization focuses on the privacy risks and states how, why, and to whom the PHI will be shared.

The authorization core elements and a sample authorization form can be found online at

http://privacyruleandresearch.nih.gov/authorization.asp (U.S. DHHS, 2007a). The authorization

information can be included as part of the consent form or as a separate form.

Critical Appraisal Guidelines to Examine Informed Consent in Studies All studies require obtaining informed consent from the study participants or subjects. The con-

sent process must meet the U.S. DHHS (2009), FDA (2012a), and HIPAA (U.S. DHHS, 2007a)

regulations for the conduct of ethical research with human subjects. Research reports often discuss

the consent process and identify some of the essential consent information that was provided to the

potential subjects. Some mention of the consent process for that study is required, but the depth of

the discussion will vary according to the research purpose and types of participants or subjects

included in the study. The consent process is usually presented in the methods section under a

discussion of study procedures or data collection process. The following critical appraisal guide-

lines will assist you in examining the consent process of a published study or for a study to be

conducted in your clinical agency.

? CRITICAL APPRAISAL GUIDELINES Examining Informed Consent Process

Consider the following questions when critically appraising the consent process of a study (Banner & Zimmer,

2012; U.S. DHHS, 2009; FDA, 2012a; Simpson, 2010):

1. Was informed consent obtained from the subjects or participants?

2. Was the essential information for consent provided and comprehended by the subjects?

3. Were the subjects competent to give consent? If the subjects were not competent to give consent, who

acted as their legally authorized representatives?

4. Did it seem that the subjects participated voluntarily in the study?

115CHAPTER 4 Examining Ethics in Nursing Research

RESEARCH EXAMPLE

Informed Consent

Research Study Excerpt Franklin and Harrell (2013) conducted a study to examine the influence of rheumatoid arthritis (RA)–related

fatigue on the psychological outcomes of depressive symptoms, perceived health impairment, and satisfaction with

abilities in adults with RA. The following excerpt documents the process for obtaining informed consent from the

participants in this study.

Methods Participants

“The sample for this study was recruited from the general community, including local senior centers, inde-

pendent and assisted living facilities, community organizations, and retirement communities in East Central

Florida. . . . Eligibilty criteria included . . . willingness to participate, including signing the informed consent

form, with acknowledgment that the participant understood the information presented within the consent

form. Participants did not receive compensation for their participation. . . .”

Procedure “The study and all procedures were approved by the university’s human subject institutional review

board. Questionnaires and consent forms were provided to community agencies. The agencies distributed

the instruments to their members or residents who expressed a willingness to complete the question-

naires. Informed consent was obtained in the presence of agency personnel who had been briefed on

the study so they could address participant questions. In addition, participants were provided with a

phone number to contact researchers with any questions. Completed questionnaires and consent forms

were returned to the researchers via mail, using a provided self-addressed, stamped envelope. Names

appeared only on the signature line of the consent forms, which were separated from the completed

questionnaires and maintained separately to insure anonymity of participants.” Franklin & Harrell, 2013,

pp. 204-205

Critical Appraisal Franklin and Harrell (2013) identified the essential elements of the informed consent process in their research

report. They indicated that the study participants were provided information about the study and their signing

of the consent form indicated that they understood the information presented. The consent process was voluntary

because only those individuals willing to participate were asked to sign a consent form and complete the study ques-

tionnaire. The study participants were given the right to ask questions and their information was kept confidential.

The consent process would have been strengthened by a discussion of the benefits and risks of the study and com-

pliance with HIPAA regulations.

Implications for Practice Franklin and Harrell (2013) found that RA-related fatigue had a clinically and statistically significant impact on

psychological well-being (depressive symptoms, perceived health impairment, and satisfaction with ability) of older

adults. Because the sample was comprised of older adults (age range, 55 to 89 years; mean age, 66.7 years), the find-

ings cannot be generalized to other adults with RA. The researchers recommended future research using a larger

sample to include males and younger patients to determine the influence of age and gender on the relationship

of fatigue with psychological well-being.

116 CHAPTER 4 Examining Ethics in Nursing Research

UNDERSTANDING INSTITUTIONAL REVIEW

In institutional review, a study is examined for ethical concerns by a committee knowledgeable

about research and clinical practice. The first federal policy statement on protection of human sub-

jects by institutional review was issued by the Public Health Service (PHS) in 1966. The statement

required that research involving human subjects must be reviewed by a committee of peers or asso-

ciates to confirm that (1) the rights and welfare of the persons involved were protected, (2) the

appropriate methods were used to secure informed consent, and (3) the potential benefits of

the investigation were greater than the risks (Levine, 1986).

In 1974, DHEW passed the National Research Act, which required that all research involving

human subjects undergo institutional review. The DHHS reviewed and revised these guidelines

several times, with the last revision in 2009 (45 CFR, Sections 46.107-46.115). The FDA

(2012b, 21 CFR, Part 56) also has very similar guidelines for institutional review of research.

The regulations describe the membership, functions, and operations of the body responsible

for institutional review. An institutional review board (IRB) is a committee that reviews research

to ensure that the investigator is conducting the research ethically. Universities, hospitals, corpo-

rations, and many managed care centers have IRBs to promote the conduct of ethical research and

protect the rights of prospective subjects at their institutions (Fry et al., 2011; Munhall, 2012b).

Each IRB has at least five members of varying backgrounds (cultural, economic, educational,

gender, racial) to promote complete, scholarly, and fair review of research commonly conducted in

an institution. If an institution regularly reviews studies with vulnerable subjects, such as children,

neonates, pregnant women, prisoners, and the mentally disabled, the IRB must include one or

more members with knowledge about and experience in working with these subjects. The mem-

bers must have sufficient experience and expertise to review a variety of studies, including quan-

titative, qualitative, and outcomes research studies (Grove et al., 2013; Munhall, 2012b). The IRB

members must not have a conflicting interest related to a study conducted in an institution. Any

member having a conflict of interest with a research project being reviewed must excuse himself or

herself from the review process for that study, except to provide information requested by the IRB.

The IRB also must include one member whose primary concern is nonscientific, such as an ethicist,

lawyer, or minister. At least one of the IRB members must be someone who is not affiliated with the

institution (U.S. DHHS, 2009; FDA, 2012b). IRBs in hospitals often are composed of physicians,

nurses, lawyers, scientists, clergy, and community laypersons.

The FDA (2012b) regulations were revised to require all IRBs to register through a system main-

tained by the DHHS. The registration information includes contact information for IRB members

(e.g., addresses, telephone numbers, and e-mail), the number of active protocols involving FDA-

regulated products reviewed during the preceding 12 months, and a description of the types of

FDA-regulated products involved in the protocols reviewed (FDA, 2012b). The IRB registration

requirement was implemented to make it easier for the FDA to inspect IRBs and communicate

information to them. IRB registration must be renewed every 3 years and can be done online

at http://ohrp.cit.nih.gov/efile.

Levels of Reviews Conducted by Institutional Review Boards The functions and operations of an IRB involve the review of research at three different levels: (1)

exempt from review, (2) expedited review, and (3) complete review. The IRB chairperson and/or

committee, not the researcher, decide the level of the review required for each study. Studies usually

are exempt from review if they pose no apparent risks for the research subjects. A common type

of exempt study is when de-identified data from patient charts are analyzed. Nursing studies

117CHAPTER 4 Examining Ethics in Nursing Research

that carry no foreseeable risks for subjects often are considered exempt from review by the IRB

committee.

Studies that carry some risks, which are viewed as minimal, qualify for an expedited review.

Minimal risk means that “the probability and magnitude of harm or discomfort anticipated in

the research are not greater in and of themselves than those ordinarily encountered in daily

life or during the performance of routine physical or psychological examinations or tests”

(U.S. DHHS, 2009, 45 CFR, Section 46.102i). Expedited review procedures also can be used to

review minor changes in previously approved research. Under expedited review procedures, the

review may be carried out by the IRB chairperson or one or more experienced reviewers designated

by the chairperson from among members of the IRB. In reviewing the research, the reviewers may

exercise all the authority of the IRB, except disapproval of the research. A research activity may be

disapproved only after a complete review of the IRB (U.S. DHHS, 2009; FDA, 2012b). Descriptive

studies, in which subjects are asked to respond to questionnaires, commonly need only expedited

review.

A study that carries greater than minimal risks must receive a complete review by an IRB. To

obtain IRB approval, researchers must ensure that (1) risks to subjects are minimized, (2) risks to

subjects are reasonable in relation to anticipated benefits, (3) selection of subjects is equitable, (4)

informed consent will be sought from each prospective subject or the subject’s legally authorized

representative, (5) informed consent will be appropriately documented, (6) the research plan

makes adequate provision for monitoring data collection for subject’s safety, and (7) adequate pro-

visions are made to protect the privacy of subjects and maintain the confidentiality of data (U.S.

DHHS, 2009; FDA, 2012b).

Most studies indicate that IRB approval was obtained, but do not indicate whether the study

was exempt from review, expedited review, or complete review. If a researcher is affiliated with a

university, the study needs to be approved by the IRB of that university before seeking IRB

approval from the clinical agency in which the study is to be conducted. In the study conducted

by Cerdan and colleagues (2012, p. 132; see earlier), the researchers obtained “IRB approval at the

University of Nevada, Las Vegas. . . . The participants were chosen from a pediatric pulmonology

outpatient clinic located in Las Vegas, Nevada.” The researchers did not identify the IRB approval

from the clinic, but it might have been part of the university medical center.

If a study is conducted in more than one clinical agency, researchers must obtain IRB approval

from all clinical sites in which the study is to be conducted. A research report needs to identify

the IRBs that reviewed and approved a study for implementation clearly. For example,

Elshatarat, Stotts, Engler, and Froelicher (2013) conducted a descriptive study of the knowledge

and beliefs about smoking and goals of smoking cessation in men hospitalized with cardiovascular

disease. “The Committee on Human Research at the University of California, San Francisco

approved this study as did the Directors of Nursing and the Chief Medical Officers of the two hos-

pitals. All subjects provided written informed consent” (p. 127). These researchers documented

IRB approval of the university and administrative approval of the two hospitals in which the study

was conducted.

Influence of Health Insurance Portability and Accountability Act Privacy Rule on Institutional Review Boards Under the HIPAA Privacy Rule, an IRB or institutional established privacy board can act on

requests for a waiver or an alteration of the authorization requirement for a research project.

If an IRB and privacy board both exist in an agency, the approval of only one board is required;

118 CHAPTER 4 Examining Ethics in Nursing Research

it will probably be the IRB for research projects. Researchers can choose to obtain a signed autho-

rization form from potential subjects or can ask for a waiver or alteration of the authorization

requirement. An altered authorization requirement is when an IRB approves a request that some,

but not all, of the required 18 elements be removed from health information to be used in

research. The researcher can also request a partial or complete waiver of the authorization require-

ment from the IRB. The partial waiver involves the researcher’s obtaining PHI to contact and

recruit potential subjects for a study. An IRB can give a researcher a complete waiver of autho-

rization in studies in which the requirement for a written or signed consent form was waived

(U.S. DHHS, 2007a). The HIPAA regulations related to IRBs can be found online at http://

privacyruleandresearch.nih.gov/irbandprivacyrule.asp. The HIPAA Privacy Rule does not change

the IRB membership and functions that are designated under the U.S. DHHS (2009) and FDA

(2012b) IRB regulations.

EXAMINING THE BENEFIT-RISK RATIO OF A STUDY

Nurses who serve on an IRB for their agency, serve as patient advocates when research is con-

ducted in their agency, or are asked to collect data for a study should examine the balance of

benefits and risks in studies. To determine this balance, or benefit-risk ratio, the benefits and

risks associated with the sampling method, consent process, procedures, and potential outcomes

of the study are assessed (Figure 4-2). Informed consent must be obtained from subjects, and

Developing a Study Benefit-Risk Ratio

Benefits are greater than or equal

to risks

Risks outweigh benefits

Predict the outcomes of the study

Assess benefits

Assess risks

Approve study

Reject study

Benefit-risk ratio Maximize benefits and minimize risks

FIG 4-2 Balancing benefits and risks for a study.

119CHAPTER 4 Examining Ethics in Nursing Research

selection and treatment of subjects during the study must be fair. An important outcome of

research is the development and refinement of knowledge. The type of knowledge that might

be obtained from the study and who will be influenced by the knowledge also need to be

identified.

The type of research conducted—therapeutic or nontherapeutic—affects the potential benefits

for subjects. In therapeutic research, subjects might benefit from the study procedures in areas such

as skin care, range of motion, touch, and other nursing interventions. The benefits might include

improved physical condition, which could facilitate emotional and social benefits. Some

researchers have noted that participation in qualitative research has encouraged subjects to process

and disclose thoughts regarding life-altering events, and that these actions have been beneficial to

the subjects’ health and well-being (Eide & Kahn, 2008, Munhall, 2012a). Nontherapeutic nursing

research does not benefit subjects directly, but is important because it generates and refines nursing

knowledge for future patients, the nursing profession, and society. Most subjects involved in a

study do benefit by having an increased understanding of the research process and knowing

the findings from a particular study.

Examining the benefit-risk ratio also involves assessing the type, degree, and number of risks

that subjects might encounter while participating in a study. The risks involved depend on the

purpose of the study and procedures used to conduct the study. Risks can be physical, emotional,

social, or economic and can range from no anticipated risk or mere inconvenience to certain risk of

permanent damage (see earlier, “Right to Protection from Discomfort and Harm”; Fry et al., 2011;

Reynolds, 1972). If the risks outweigh the benefits, the study probably is unethical and should not

be conducted. If the benefits outweigh the risks, the study probably is ethical and has the potential

to add to nursing’s knowledge base (see Figure 4-2; Grove et al., 2013).

Critical Appraisal Guidelines for Examining the Ethical Aspects of Studies The following guidelines can be used to critically appraise the ethical aspects of a study. These

guidelines include (1) examination of the benefit-risk ratio of the study, (2) IRB approval,

(3) informed consent, and (4) protection of subjects’ human rights. This information needs to

be included in published studies.

? CRITICAL APPRAISAL GUIDELINES Examining the Ethical Aspects of a Study

When conducting a study, researchers must meet the U.S. DHHS (2009), FDA (2012a, 2012b), and HIPAA (U.S.

DHHS, 2007a) regulations for the conduct of ethical research with human subjects. Consider the following ques-

tions when critically appraising the ethical aspects of a study:

1. Was the benefit-risk ratio of the study acceptable? Was the level of risk reasonable for the study and did the

benefits outweigh the risks? (Use Figure 4-2 to examine the benefit-risk ratio of the study.)

2. Was the study approved by the appropriate IRB(s)?

3. Was informed consent obtained from the subjects? (Refer to the previous guidelines for examining the con-

sent process in studies.)

4. Were the rights of the subjects protected during the study? (Refer to the previous guidelines for examining

the protection of subjects’ rights in research.)

120 CHAPTER 4 Examining Ethics in Nursing Research

RESEARCH EXAMPLE

Determining the Ethics of a Study

Research Study Excerpt Rew, Horner, and Fouladi (2010) conducted a study of school-age children’s health behaviors to determine if they

were precursors of adolescents’ health-risk behaviors. The sample included Hispanic and non-Hispanic children and

their parents. The ethical aspects of the study are described in the following quote.

Setting and Sample “The study took place in a rural setting in central Texas, a state with a rapidly expanding population of His-

panics, primarily of Mexican descent. The nonprobability sample was composed of 1,934 children in grades 4

(n¼781), 5 (n¼621), and 6 (n¼532) who were enrolled in three rural school districts in central Texas and one of their parents.” Rew et al., 2010, p. 158

Data Collection Procedure “After study approval was obtained from the university’s institutional review board [IRB] and each of the

school administrators, a packet was mailed to parents of all the children in grades 4 through 6 in three rural

school districts. The packets included a cover letter from the child’s school, an explanatory letter from the

researchers, and consent forms. All materials were written in English and Spanish, with forward and back-

ward translations by independent speakers, and were reviewed by bilingual members of the community for

translation clarity and accuracy before mailing. Informational meetings were held at the schools after parent-

teacher meetings. At those school meetings, the study was explained to the children, questions were

answered, and signed permissions were obtained from parents. Data were later collected during school

hours using audio (optional), computer-assisted, self-interviewing (A-CASI) technology using laptop com-

puters after the children who agreed to participate provided written assent. . . .

The children were oriented to the A-CASI format and were directed to select either the English or Spanish

language versions to complete. For children who had difficulty with reading, audio support was engaged on

the laptop computer and the children listened with an earpiece as the items were read to them in their pre-

ferred language. . . . As each child completed the questionnaires, the research assistants saved the data

record to a secure Web site.” Rew et al., 2010, p. 160

Critical Appraisal Rew and associates (2010) presented the essential information about the protection of the participants’ rights,

informed consent process, and IRB approval in their research report. They provided a detailed description of

the protection of the children and their parents’ rights. The study was described in informational meetings held

at the school in a language of choice, with an offer to answer questions. The parents agreed to their child’s partic-

ipation in the study through signed permission forms. The children gave written assent to participate in the study.

IRB approvals of the university and school administrators were obtained, and the storage of study data in a secure

location protected the privacy of the participants. All these activities promoted the ethical conduct of this study,

according to the U.S. DHHS (2009) regulations. The benefit-risk ratio of this study was acceptable because the risk

level of completing an online survey was minimal and the benefits of understanding adolescents’ health-promoting

and health-risk behaviors provide a basis for developing school wellness programs.

Implications for Practice Rew and co-workers (2010) found that girls have more health-focused behaviors than boys, and the health behaviors

decreased from grades 4 to 6. In addition, the school environment was found to be an important place for promoting

healthy behaviors. The researchers encouraged school nurses, administrators, teachers, and parents to develop well-

ness policies and programs within the schools to increase the students’ health-promoting behaviors and decrease

their health-risk behaviors. Consistent with QSEN (2013) competencies, the findings could be integrated with other

research evidence and used in practice, with the goal of providing evidence-based nursing care (Brown, 2014).

121CHAPTER 4 Examining Ethics in Nursing Research

UNDERSTANDING RESEARCH MISCONDUCT

The goal of research is to generate sound scientific knowledge, which is possible only through the

honest conduct, reporting, and publication of studies. However, since the 1980s, a number of

fraudulent studies have been conducted and published in prestigious scientific journals. An exam-

ple of research misconduct is the work of Marc Hauser, a former professor at Harvard University.

He was found to have committed eight incidences of research misconduct in his studies of the

development of human and monkey cognition (Office of Research Integrity, 2012b). He was cited

for miscoding data, fabricating data, and misrepresenting study methods. Another example of

research misconduct was evident in the publications of Dr. Robert Slutsky, a heart specialist at

the University of California, San Diego, School of Medicine, whose study results raised questions

of data fabrication (Friedman, 1990). In 6 years, Slutsky published 161 articles, and at one time, he

was completing an article every 10 days. Of these articles, 18 were found to be fraudulent and have

retraction notations, and 60 articles were judged to be questionable.

In response to the increasing incidences of scientific misconduct, the federal government devel-

oped the Office of Research Integrity (ORI) in 1989 within the U.S. DHHS. The ORI was to super-

vise the implementation of the rules and regulations related to research misconduct and to manage

any investigations of misconduct. The most current regulations implemented by the ORI (2005)

are CFR 42, Parts 50 and 93, Policies of General Applicability, discussed in the following section.

Role of the Office of Research Integrity in Promoting the Conduct of Ethical Research The ORI was responsible for defining important terms used in the identification and management

of research misconduct. Research misconduct is defined as “the fabrication, falsification, or pla-

giarism in processing, performing, or reviewing research, or in reporting research results. It does

not include honest error or differences in opinion” (ORI, 2005, 42 CFR, Section 93.103). Fabri-

cation in research is the making up of results and recording or reporting them. Falsification of

research is manipulating research materials, equipment, or processes or changing or omitting data

or results such that the research is not accurately represented in the research record. Fabrication

and falsification of research data are two of the most common acts of research misconduct man-

aged by ORI (2013) over the last 5 years. Plagiarism is the appropriation of another person’s ideas,

processes, results, or words without giving appropriate credit, including those obtained through

confidential review of others’ research proposals and manuscripts.

Currently, ORI promotes the integrity of biomedical and behavioral research in approximately

4000 institutions worldwide (ORI, 2012a). ORI applies federal policies and regulations to protect

the integrity of the PHS’s extramural and intramural research programs. The extramural program

provides funding to research institutions, and the intramural program provides funding for

research conducted within the federal government.

The ORI classifies research misconduct as (1) an act that involves a significant departure from

the acceptable practice of the scientific community for maintaining the integrity of the research

record, (2) an act that was committed intentionally, and (3) an allegation that can be proved

by a preponderance of evidence. ORI has a section on their website (http://ori.U.S.DHHS.gov/

case_summary) entitled “Handling Misconduct,” which includes a summary of the allegations

and investigations managed by its office from 1994 to present (ORI, 2013). The most common

sites for the investigations were medical schools (68%), hospitals (11%), and research institutes

(10%). The individuals charged with misconduct were primarily men with a doctorate or medical

degree and were mostly associate professors, professors, and postdoctoral fellows.

122 CHAPTER 4 Examining Ethics in Nursing Research

Research misconduct has also been reported in the nursing profession (Habermann, Broome,

Pryor, & Ziner, 2010; Rankin & Esteves, 1997). A specific example of a nurse found guilty of

research misconduct was Scott Weber, who was found to have plagiarized significant portions

of published articles, including using prior studies’ data in graphs in his publications (ORI,

2011). He also changed the years of some cited articles in his reference lists to avoid detection

of plagiarism. Habermann and colleagues (2010) conducted a study of research coordinators’

experiences with scientific misconduct and research integrity and found that research coordinators

often learned of the misconduct firsthand, and the principal investigator was usually identified as

the responsible party. They identified five major categories of misconduct: “protocol violations,

consent violations, fabrication, falsification, and financial conflict of interest” (Habermann

et al., 2010, p. 51). They indicated that the definition of research misconduct might need to be

expanded beyond fabrication, falsification, and plagiarism.

When research misconduct was documented, the actions taken against the researchers or agen-

cies included debarment from receiving federal funding for periods ranging from 18 months to

8 years, prohibition from PHS advisory services, and other actions requiring supervised research,

certification of data, certification of sources, and correction or retraction of articles (ORI, 2013).

More information on the handling of research misconduct can be found on the ORI website

(http://ori.U.S.DHHS.gov/handling-misconduct).

EXAMINING THE USE OF ANIMALS IN RESEARCH

The use of animals as research participants is a controversial issue of growing interest to nurse

researchers. A small but increasing number of nurse scientists are conducting physiological studies

that require the use of animals. For decades, animals have been used in the conduct of biomedical

and biobehavioral research and have significantly contributed to our understanding of disease pro-

cesses. Animals will also play an important role in genetics research. Renn and Dorsey (2011) have

provided some important information to assist researchers in determining when and how animals

might best be used to generate research knowledge. Selected animal rights groups, however, are

very opposed to research using animals. Many scientists, especially physicians, believe that the cur-

rent animal rights’ movement could threaten the future of healthcare research. The goal of these

groups is to raise the consciousness of researchers and society to ensure that animals are used

wisely and treated humanely in the conduct of research. However, some of these animal rights

groups have tried to frighten the public with somewhat distorted stories about the inhumane treat-

ment of animals in research. Some activist leaders have made broad comparisons between human

life and animal life. For example, a major animal rights group, People for the Ethical Treatment of

Animals (PETA), has a website that posts videos and blogs about the unethical treatment of ani-

mals in research (http://www.peta.org/tv/videos/investigations-animal-experimentation). Some of

these activists have now progressed to violence, using physical attacks, including real bombs, arson,

and vandalism. Even more damage is being done to research through lawsuits that have blocked the

conduct of research and the development of new research centers. Health science centers now

spend millions of dollars annually for security, public education, and other efforts to defend

research conducted with animals.

Because more nurses are conducting research with animals, the ethics of these studies need to be

critically appraised. An important question to address is: What mechanisms ensured that the ani-

mals were treated humanely in the conduct of the study? Animals are just one of a variety of types

of subjects used in research; others include humans, plants, and computer data sets. If possible,

123CHAPTER 4 Examining Ethics in Nursing Research

most researchers use nonanimal subjects, because they are generally less expensive (Latham, 2012).

In low-risk studies, as are most nursing studies, humans are often used as subjects.

Some studies, however, require the use of animals to answer the research question. Approxi-

mately 17 to 22 million animals are used in research each year, and 90% of them are rodents, with

the combined percentage of dogs and cats being only 1% to 2% (Goodwin & Morrison, 2000; Renn

& Dorsey, 2011). Studies using animals comprise about one eighth of published studies (Osborne,

Payne, & Newman, 2009). Because animals are deemed valuable subjects for selected research pro-

jects, the question concerning their humane treatment must be addressed. Recent studies have

indicated that animals experience a wider variety of harm, including fear and pain, than was pre-

viously thought (Ferdowsian, 2011).

Currently at least five separate types of regulations exist to protect research animals from mis-

treatment. The federal government, state governments, independent accreditation organizations,

professional societies, and individual institutions work to ensure that research animals are used

only when necessary and only under humane conditions. At the federal level, animal research

is conducted according to the guidelines of the PHS Policy on Humane Care and Use of Laboratory

Animals, which was adopted in 1986 and reprinted essentially unchanged in 1996. The most cur-

rent addition to this federal policy is the revised guidelines for euthanasia of animals. These policies

are managed by the Office of Laboratory Animal Welfare (OLAW, 2013), and are available on their

website at http://grants.nih.gov/grants/olaw/olaw.htm.

The Humane Care and Use of Laboratory Animals Regulations define animal as any live, ver-

tebrate animal used or intended for use in research, research training, experimentation, or biolog-

ical testing or for related purposes. Any institution proposing research involving animals must

have a written animal welfare assurance statement acceptable to the PHS that documents compli-

ance with PHS policy. Every assurance statement is evaluated by the National Institutes of Health’s

Office for Protection from Research Risks (OPRR) to determine the adequacy of the institution’s

proposed program for the care and use of animals in activities conducted or supported by the PHS

(OLAW, 2011). Researchers using animals are required to develop an animal use protocol that

describes the following elements: (1) research project; (2) rationale for animal use and consider-

ation of alternatives; (3) justification for the choice of species and numbers of animals; (4) research

procedures involving animals; (5) procedures to minimize pain and distress; (6) animal living con-

ditions and veterinary care; (7) names and qualifications of personnel who will perform work with

animals; (8) method of euthanasia; and (9) endpoint criteria. The OLAW (2011) website includes

guidelines for the care and use of animals in research (http://grants.nih.gov/grants/policy/air/

researchers_institutions.htm).

Institutions’ assurance statements about compliance with PHS policy have promoted the

humane care and treatment of animals in research. In addition, more than 700 institutions con-

ducting health-related research have sought accreditation by the American Association for Accred-

itation of Laboratory Animal Care (AAALAC), which was developed to ensure the humane

treatment of animals in research (OLAW, 2011). In conducting research, each investigator must

carefully select the type of participant needed; if animals are used in a study, they require humane

treatment. Osborne and associates (2009) conducted a study to determine journals’ editorial pol-

icies regarding animal research. They found that journals need clear policies on the essential infor-

mation to be included in a research report to reflect the fair treatment of animals in studies. In

critically appraising studies, you need to ensure that animals were the appropriate subjects for

a study and that they were treated humanely during the conduct of the study (OLAW, 2011, 2013).

Sharma, Ryals, Gajewski, and Wright (2010) noted that the molecular basis for the positive

effects of exercise on chronic pain was poorly understood. Therefore they conducted an

124 CHAPTER 4 Examining Ethics in Nursing Research

experimental study of the effects of aerobic exercise on analgesia and neurotrophin-3 (NT-3) syn-

thesis in female mice. They noted that “all experiments were approved by the Institutional Animal

Care and Use Committee of the University of Kansas Medical Center and adhered to the univer-

sity’s animal care guidelines” (Sharma et al., 2010, p. 715). Following these guidelines provided for

the humane treatment of the animals in this study. The researchers found that moderate-intensity

aerobic exercise reduced cutaneous and deep tissue pain and stimulated NT-3 synthesis in skeletal

muscle, providing a possible molecular basis for the effects of exercise training on muscle pain.

However, these results are limited to animals; further research is needed to determine the effects

of exercise on humans with chronic pain.

K E Y C O N C E P T S

• Four experimental projects have been highly publicized for their unethical treatment of human

subjects: (1) the Nazi medical experiments; (2) the Tuskegee Syphilis Study; (3) the Willow-

brook Study; and (4) the Jewish Chronic Disease Hospital Study.

• Two historical documents, the Nuremberg Code and Declaration of Helsinki, have had a strong

impact on the conduct of research.

• U.S. DHHS (2009) and FDA (2012a, b) regulations have been implemented to promote ethical

conduct in research, including (1) general requirements for informed consent and (2) guide-

lines for IRB review of research.

• The HIPAA Privacy Rule (2007a) was enacted to protect the privacy of people’s health

information.

• The human rights that require protection in research are the right to (1) self-determination, (2)

privacy, (3) anonymity and confidentiality, (4) fair selection and treatment, and (5) protection

from discomfort and harm.

• Informed consent involves (1) transmission of essential study information to the potential sub-

ject, (2) comprehension of that information by the potential subject, (3) competence of the

potential subject to give consent, and (4) voluntary consent by the potential subject to partic-

ipate in the study.

• An institutional review board consists of a committee of peers who examine studies for ethical

concerns with three levels of review—exempt, expedited, and complete.

• To balance the benefits and risks of a study, the type, degree, and number of risks are examined,

and the potential benefits are identified. The benefits should overshadow the risks.

• Research misconduct is a serious ethical problem concerned with the conducting, reporting,

and publication of fraudulent research.

• Animals are important for the conduct of certain studies, and they must be treated humanely

during the study.

REFERENCES

American Nurses Association, (2001). Code of ethics for

nurses with interpretive statements. Washington, DC:

Author.

American Psychological Association, (2010). Ethical

principles of psychologists and code of conduct. Retrieved

June 9, 2013 from, http://www.apa.org/ethics/code/

index.aspx.

Banner, C., & Zimmer, L. (2012). Informed consent in

research: An overview for nurses. Canadian Journal of

Cardiovascular Nursing, 22(1), 26–30.

Beebe, L. H., & Smith, K. (2010). Informed consent to

research in persons with schizophrenia spectrum

disorders. Nursing Ethics, 17(4), 425–434.

125CHAPTER 4 Examining Ethics in Nursing Research

Beecher, H. K. (1966). Ethics and clinical research. New

England Journal of Medicine, 274(24), 1354–1360.

Berger, R. L. (1990). Nazi science: The Dachau

hypothermia experiments. New England Journal of

Medicine, 322(20), 1435–1440.

Brandt, A. M. (1978). Racism and research: The case of the

Tuskegee syphilis study. Hastings Center Report, 8(6),

21–29.

Broome, M. E. (1999). Consent (assent) for research with

pediatric patients. Seminars in Oncology Nursing, 15(2),

96–103.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Cerdan, N. S., Alpert, P. T., Moonie, S., Cyrkiel, D., &

Rue, S. (2012). Asthma severity in children and the

quality of life of their parents. Applied Nursing

Research, 25(3), 131–137.

Eide, P., & Kahn, D. (2008). Ethical issues in the qualitative

researcher-participant relationship. Nursing Ethics,

15(2), 199–207.

Elshatarat, R. A., Stotts, N. A., Engler, M., & Froelicher, E.

S. (2013). Knowledge and beliefs about smoking

and goals for smoking cessation in hospitalized men

with cardiovascular disease. Heart & Lung, 42(2),

126–132.

Emanuel, E. J. (2004). Ending concerns about undue

inducement. The Journal of Law, Medicine & Ethics: A

Journal of the American Society of Law, Medicine &

Ethics, 32(1), 100–105.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia: F. A.

Davis.

Ferdowsian, H. (2011). Human and animal research

guidelines: Aligning ethical constructs with new

scientific developments. Bioethics, 25(8), 472–478.

Fowler, M. D. M. (2010). Guide to the code of ethics for

nursing: Interpretation and application. Silver Spring,

MD: American Nurses Association.

Franklin, A. L., & Harrell, T. H. (2013). Impact of fatigue

on psychological outcomes in adults living with

rheumatoid arthritis. Nursing Research, 62(3),

203–209.

Friedman, P. J. (1990). Correcting the literature following

fraudulent publication. Journal of the American Medical

Association, 263(10), 1416–1419.

Fry, S. T., Veatch, R. M., & Taylor, C. (2011). Case studies in

nursing ethics (4th ed.). Sudbury, MA: Jones & Bartlett

Learning.

Goodwin, F. K., & Morrison, A. R. (2000). Science and self-

doubt. Reason, 32(5), 22–28.

Greaney, A., Sheehy, A., Heffernan, C., Murphy, J.,

Mhaolrunaigh, S. N., Heffernan, E., et al. (2012).

Research ethics application: A guide for the novice

nurse researcher. British Journal of Nursing, 21(1),

38–43.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice

of nursing research: Appraisal, synthesis, and

generation of evidence (7th ed.). Philadelphia: Elsevier

Saunders.

Habermann, B., Broome, M., Pryor, E. R., & Ziner, K. W.

(2010). Research coordinators’ experiences with

scientific misconduct and research integrity. Nursing

Research, 59(1), 51–57.

Hadley, E. K., Smith, C. A., Gallo, A. M., Angst, D. B., &

Knafl, K. A. (2007). Parents’ perspectives on having

their children interviewed for research. Research in

Nursing & Health, 31(1), 4–11.

Havens, G. A. (2004). Ethical implications for the

professional nurse of research involving human

subjects. Journal of Vascular Nursing, 22(1), 19–23.

Hershey, N., & Miller, R. D. (1976). Human

experimentation and the law. Rockville, MD: Aspen.

Infectious Diseases Society of America, (2009). Grinding

to a halt: The effects of the increasing regulatory

burden on research and quality improvement efforts.

Clinical Infectious Diseases, 49(3), 328–335.

Kelman, H. C. (1967). Human use of human subjects: The

problem of deception in social psychological

experiments. Psychological Bulletin, 67(1), 1–11.

Larson, E. L., Cohn, E. G., Meyer, D. D., & Boden-

Albala, B. (2009). Consent administrator training to

reduce disparities in research participation. Journal of

Nursing Scholarship, 41(1), 95–103.

Latham, S. (2012). U. S. law and animal experimentation.

Hastings Center Reports, 42, S35–S39.

Levine, R. J. (1986). Ethics and regulation of clinical research

(2nd ed.). Baltimore: Urban & Schwarzenberg.

Milgram, S. (1963). Behavioral study of obedience.

Journal of Abnormal and Social Psychology, 67(4),

371–378.

Munhall, P. L. (2012a). Ethical considerations in

qualitative research. In P. L. Munhall (Ed.), Nursing

research: A qualitative perspective (pp. 491–502). (5th

ed.). Sudbury, MA: Jones & Bartlett Learning.

Munhall, P. L. (2012b). Institutional review of qualitative

research proposals: A task of no small consequence. In

P. L. Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 503–515). (5th ed.). Sudbury, MA:

Jones & Bartlett Learning.

National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research,

126 CHAPTER 4 Examining Ethics in Nursing Research

(1978). Belmont report: Ethical principles and guidelines

for research involving human subjects. DHEW

Publication No. (05) 78-0012. Washington, DC: U.S.

Government Printing Office.

Office of Laboratory Animal Welfare (OLAW), (2011). For

researchers and institutions: Good animal care and good

science go hand-in-hand. Retrieved June 9, 2013 from,

http://grants.nih.gov/grants/policy/air/researchers_

institutions.htm.

Office of Laboratory Animal Welfare (OLAW), (2013).

OLAW policies and laws. Retrieved June 9, 2013 from,

http://grants.nih.gov/grants/olaw/olaw.htm.

Office of Research Integrity (ORI), (2005). Public health

service policies on research misconduct. Code of Federal

Regulations,Title 42, Parts 50 and 93, Policies of

General Applicability. Retrieved June 9, 2013 from,

http://ori.U.S.DHHS.gov/documents/FR_Doc_05-

9643.shtml.

Office of Research Integrity (ORI), (2011). Case summary:

Weber, Scott. Retrieved June 8, 2013 from, http://ori.

hhs.gov/content/case-summary-weber-scott.

Office of Research Integrity (ORI), (2012a). About ORI.

Retrieved June 9, 2013 from, http://ori.U.S.DHHS.gov/

about-ori.

Office of Research Integrity (ORI), (2012b). Case summary:

Hauser, Marc. Retrieved June 8, 2013 from, http://ori.

hhs.gov/content/case-summary-hauser-marc.

Office of Research Integrity (ORI), (2013). Handling

misconduct—Case summaries. Office of Research

Integrity. Retrieved May 29, 2013 from, http://ori.U.S.

DHHS.gov/misconduct/cases/.

Olsen, D. P. (2003). Methods: HIPAA privacy regulations

and nursing research. Nursing Research, 52(5),

344–348.

Osborne, N. J., Payne, D., & Newman, M. L. (2009).

Journal editorial policies, animal welfare, and the 3Rs.

The American Journal of Bioethics, 9(12), 55–59.

Quality and Safety Education for Nurses (QSEN), (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved February 11, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas/.

Rankin, M., & Esteves, M. D. (1997). Perceptions of

scientific misconduct in nursing. Nursing Research,

46(5), 270–276.

Renn, C. L., & Dorsey, S. G. (2011). From mouse to man:

The efficacy of animal models of human disease in

genetic and genomic research. Annual Review of

Nursing Research, 29, 99–112.

Rew, L., Horner, S. D., & Fouladi, R. T. (2010). Factors

associated with health behaviors in middle childhood.

Journal of Pediatric Nursing, 25(3), 157–166.

Reynolds, P. D. (1972). On the protection of human

subjects and social science. International Social Science

Journal, 24(4), 693–719.

Reynolds, P. D. (1979). Ethical dilemmas and social science

research. San Francisco: Jossey-Bass.

Rosato, J. (2000). The ethics of clinical trials: A child’s view.

The Journal of Law, Medicine & Ethics: A Journal of the

American Society of Law, Medicine & Ethics, 28(4),

362–378.

Rotenberg, M. A., & Rudnick, A. (2011). Reporting of

ethics procedures in psychiatric rehabilitation peer-

reviewed empirical research publications in the last

decade. American Journal of Psychiatric Rehabilitation,

14(2), 97–108.

Rothman, D. J. (1982). Were Tuskegee and Willowbrook

“studies in nature?” Hastings Center Report, 12(2), 5–7.

Sandelowski, M. (1994). Focus on qualitative methods:

The use of quotes in qualitative research. Research in

Nursing & Health, 17(6), 479–482.

Savage, E., & McCarron, S. (2009). Research access to

adolescents and young adults. Applied Nursing

Research, 22(1), 63–67.

Sharma, N. K., Ryals, J. M., Gajewski, B. J., & Wright, D. E.

(2010). Aerobic exercise alters analgesia and

neurotropin-3 synthesis in an animal model of chronic

widespread pain. Physical Therapy, 90(5), 714–725.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Simpson, C. (2010). Decision-making capacity and

informed consent to participate in research by

cognitively impaired individuals. Applied Nursing

Research, 23(4), 221–226.

Steinfels, P., & Levine, C. (1976). Biomedical ethics and the

shadow of Nazism. Hastings Center Report, 6(4), 1–20.

Stone, P. W. (2003). Ask an expert: HIPAA in 2003 and its

meaning for nurse researchers. Applied Nursing

Research, 16(4), 291–293.

Thompson, P. J. (1987). Protection of the rights of children

as subjects for research. Journal of Pediatric Nursing, 2

(6), 392–399.

U.S. Department of Health and Human Services (U.S.

DHHS), (1981). Final regulations amending basic HHS

policy for the protection of human research subjects.

Code of Federal Regulations, Title 45, Part 46.

U.S. Department of Health and Human Services (U.S.

DHHS), (2007a). HIPAA privacy rule: Information for

researchers. Retrieved May 29, 2013 from, http://

privacyruleandresearch.nih.gov/.

U.S. Department of Health and Human Services (U.S.

DHHS), (2007b). How do other privacy protections

127CHAPTER 4 Examining Ethics in Nursing Research

interact with the privacy rule?. Retrieved May 29, 2013

from, http://privacyruleandresearch.nih.gov/pr_05.

asp.

U.S. Department of Health and Human Services (U.S.

DHHS), (2009). Protection of human subjects. Code of

Federal Regulations,Title 45, Part 46. Retrieved May 30,

2013 from, http://www.hhs.gov/ohrp/policy/

ohrpregulations.pdf.

U.S. Department of Health and Human Services (U.S.

DHHS), Office of Human Research Protection

(OHRP), (2013). The Nuremberg Code (1949).

Retrieved June 9, 2013 from, http://www.hhs.gov/ohrp/

archive/nurcode.html.

U.S. Food and Drug Administration (FDA), (2003).

Pediatric Research Equity Act. Retrieved May 31, 2013,

from, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.

cgi?dbname¼108_cong_public_laws&docid¼f: publ155.108.

U.S. Food and Drug Administration (FDA), (2012a).

Protection of human subjects (informed consent).

Code of Federal Regulations,Title 21, Part 50. Retrieved

May 15, 2013 from, http://www.accessdata.fda.gov/

scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart¼50. U.S. Food and Drug Administration (FDA), (2012b).

Institutional review boards. Code of Federal

Regulations, Title 21, Part 56. Retrieved May 29, 2013

from, http://www.accessdata.fda.gov/scripts/cdrh/

cfdocs/cfcfr/CFRsearch.cfm?CFRPart¼56. U.S. Food and Drug Administration (FDA), (2013).

Protecting and promoting your health. Retrieved May

29, 2013 from, http://www.fda.gov.

Weijer, C. (2000). The ethical analysis of risk. The

Journal of Law, Medicine & Ethics: A Journal of the

American Society of Law, Medicine & Ethics, 28(4),

344–361.

World Medical Association, (2008). Regulations and

ethical guidelines. World Medical Association

Declaration of Helsinki. Retrieved June 9, 2013 from,

http://www.wma.net/en/30publications/10policies/

b3/17c.pdf.

128 CHAPTER 4 Examining Ethics in Nursing Research

C H A P T E R

5 Research Problems, Purposes, and

Hypotheses

C H A P T E R OV E R V I E W

What Are Research Problems and Purposes?, 131

Identifying the Problem and Purpose in

Quantitative, Qualitative, and Outcomes

Studies, 133

Problems and Purposes in Types of Quantitative

Studies, 133

Problems and Purposes in Types of Qualitative

Studies, 136

Problems and Purposes in Outcomes

Research, 140

Determining the Significance of a Study Problem

and Purpose, 140

Influences Nursing Practice, 140

Builds on Previous Research, 141

Promotes Theory Testing or Development, 142

Addresses Nursing Research Priorities, 142

Examining the Feasibility of a Problem and

Purpose, 143

Researcher Expertise, 144

Money Commitment, 144

Availability of Subjects, Facilities, and

Equipment, 144

Ethical Considerations, 145

Examining Research Objectives, Questions,

and Hypotheses in Research Reports, 145

Research Objectives or Aims, 145

Research Questions, 147

Hypotheses, 149

Understanding Study Variables and Research

Concepts, 153

Types of Variables in Quantitative

Research, 153

Conceptual and Operational

Definitions of Variables in Quantitative

Research, 155

Research Concepts Investigated in Qualitative

Research, 156

Demographic Variables, 157

Key Concepts, 158

References, 158

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Identify research topics, problems, and purposes

in published quantitative, qualitative, and

outcomes studies.

2. Critically appraise the research problems and

purposes in studies.

3. Critically appraise the feasibility of a

study problem and purpose by examining

the researcher’s expertise, money commitment,

availability of subjects, facilities, and equipment,

and the study’s ethical considerations.

4. Differentiate among the types of hypotheses

(simple versus complex, nondirectional

versus directional, associative versus causal,

and statistical versus research) in published

studies.

5. Critically appraise the quality of

objectives, questions, and hypotheses presented

in studies.

6. Differentiate the types of variables in

studies.

129

7. Critically appraise the conceptual and

operational definitions of variables in published

studies.

8. Critically appraise the demographic variables

measured and the sample characteristics

described in studies.

K E Y T E R M S

Associative hypothesis, p. 149

Background for a

problem, p. 131

Causal hypothesis, p. 149

Complex hypothesis, p. 150

Conceptual definition, p. 155

Confounding variables, p. 155

Demographic variables, p. 157

Dependent (outcome)

variable, p. 153

Directional hypothesis, p. 150

Environmental variables, p. 154

Extraneous variables, p. 154

Feasibility of a study, p. 143

Hypothesis, p. 149

Independent (treatment or

intervention) variable, p. 153

Nondirectional hypothesis,

p. 150

Null hypothesis (H0), p. 151

Operational definition, p. 155

Problem statement, p. 131

Research concepts, p. 156

Research hypothesis, p. 151

Research objective or

aim, p. 145

Research problem, p. 131

Research purpose, p. 131

Research question, p. 147

Research topic, p. 130

Research variables, p. 154

Sample characteristics, p. 157

Significance of a research

problem, p. 131

Simple hypothesis, p. 150

Statistical hypothesis, p. 151

Testable hypothesis, p. 152

Variables, p. 153

We are constantly asking questions to gain a better understanding of ourselves and the world around

us. This human ability to wonder and ask creative questions is the first step in the research process. By

asking questions, clinical nurses and nurse researchers are able to identify significant research topics

and problems to direct the generation of research evidence for use in practice. A research topic is a

concept or broad issue that is important to nursing, such as acute pain, chronic pain management,

coping with illness, or health promotion. Each topic contains numerous research problems that

might be investigated through quantitative, qualitative, and outcomes studies. For example, chronic

pain management is a research topic that includes research problems such as “What is it like to live

with chronic pain?” and “What strategies are useful in coping with chronic pain?” Qualitative studies

have been conducted to investigate these problems or areas of concern in nursing (Munhall, 2012).

Quantitative studies have been conducted to address problems such as “What is the most accurate

way to assess chronic pain?” and “What interventions are effective in managing chronic pain?” Out-

comes research methodologies have been used to examine patient outcomes and the cost-

effectiveness of care provided in chronic pain management centers (Doran, 2011).

The problem provides the basis for developing the research purpose. The purpose is the goal or

focus of a study that guides the development of the objectives, questions, or hypotheses in quan-

titative and outcomes studies. The objectives, questions, or hypotheses bridge the gap between the

more abstractly stated problem and purpose and the detailed design for conducting the study.

Objectives, questions, and hypotheses include the variables, relationships among the variables,

and often the population to be studied. In qualitative research, the purpose and broadly stated

research questions guide the study of selected research concepts.

This chapter includes content that will assist you in identifying problems and purposes in a

variety of quantitative, qualitative, and outcomes studies. Objectives, questions, and hypotheses

are discussed, and the different types of study variables are introduced. Also presented are guide-

lines that will assist you in critically appraising the problems, purposes, objectives, questions,

hypotheses, and variables or concepts in published quantitative, qualitative, and outcomes studies.

130 CHAPTER 5 Research Problems, Purposes, and Hypotheses

WHAT ARE RESEARCH PROBLEMS AND PURPOSES?

A research problem is an area of concern in which there is a gap in the knowledge needed for

nursing practice. Research is required to generate essential knowledge to address the practice con-

cern, with the ultimate goal of providing evidence-based nursing care (Brown, 2014; Craig &

Smyth, 2012). In a study, the research problem (1) indicates the significance of the problem,

(2) provides a background for the problem, and (3) includes a problem statement. The signifi-

cance of a research problem indicates the importance of the problem to nursing and health care

and to the health of individuals, families, and communities. The background for a problem briefly

identifies what we know about the problem area, and the problem statement identifies the specific

gap in the knowledge needed for practice. Not all published studies include a clearly expressed

problem, but the problem usually can be identified in the first page of the report.

The research purpose is a clear, concise statement of the specific goal or focus of a study. In

quantitative and outcomes studies, the goal of a study might be to identify, describe, or examine

relationships in a situation, examine the effectiveness of an intervention, or determine outcomes of

health care. In qualitative studies, the purpose might be to explore perceptions of a phenomenon,

describe elements of a culture, develop a theory of a health situation or issue, or describe historical

trends and patterns. The purpose includes the variables or concepts, the population, and often the

setting for the study. A clearly stated research purpose can capture the essence of a study in a single

sentence and is essential for directing the remaining steps of the research process.

The research problem and purpose from the study of Piamjariyakul, Smith, Russell,

Werkowitch, and Elyachar (2013) of the effectiveness of a telephone coaching program on heart

failure home management by family caregivers are presented as an example. This example is crit-

ically appraised using the following guidelines.

? CRITICAL APPRAISAL GUIDELINES Problems and Purposes in Studies

1. Is the problem clearly and concisely expressed early in the study?

2. Does the problem include the significance, background, and problem statement?

3. Does the purpose clearly express the goal or focus of the study?

4. Is the purpose focused on the study problem statement?

5. Are the study variables and population identified in the purpose?

RESEARCH EXAMPLE

Problem and Purpose of a Quantitative Study

Research Study Excerpt Problem Significance

“Results of meta-analyses and American Heart Association (AHA) guidelines emphasize the critical impor-

tance of family caregivers’ involvement in home management of heart failure (HF). Family caregivers perform

daily HF home management and provide essential support for patients in recognizing worsening symptoms

(i.e., edema, shortness of breath; Riegel et al., 2009).” Piamjariyakul et al., 2013, p. 32 Continued

131CHAPTER 5 Research Problems, Purposes, and Hypotheses

RESEARCH EXAMPLE—cont’d

Problem Background “Results of several studies have shown that HF rehospitalization is frequently precipitated by excess dietary

sodium, inappropriate changes or reductions in taking prescribed medications, and respiratory infections, most

of which family caregivers could help prevent if they were educated to be alert for these problems. . . . One inter-

vention program found that a family partnership program on HF home care was helpful in adherence to diet with

significant reductions in patients’ urine sodium (Dunbar et al., 2005).” Piamjariyakul et al., 2013, p. 32

Problem Statement “Yet, the few available studies on providing instruction for family caregivers are limited in content and lack

guidance for implementing HF self-management strategies at home. . . . Also, in developing interventions

that involve family caregivers, researchers need to measure caregiver outcomes (i.e., burden) to ensure that

interventions do improve patient outcomes but do not have untoward negative impacts on the caregivers.”

Piamjariyakul et al., 2013, pp. 32-33

Research Purpose “The purpose of this study was to determine the feasibility and evaluate the helpfulness and costs of a coach-

ing program for family caregiver HF home care management.” Piamjariyakul et al., 2013, p. 33

Critical Appraisal Research Problem Piamjariyakul and colleagues (2013) presented a clear, concise research problem that had the relevant areas of (1) sig-

nificance, (2) background, and (3) problem statement. HF is a significant, costly chronic illness to manage, and family

caregivers are essential to the management process. A concise background of the problem was provided by discussing

studies of the effects of caregivers on the outcomes of patients with HF. The discussion of the problem concluded with a

conciseproblemstatementthatindicatedthegapintheknowledgeneededforpracticeandprovidedabasisfor thestudy

conductedbytheseresearchers.Eachproblemprovidesthebasisforgeneratingavarietyofresearchpurposesand,inthis

study, the knowledge gap regarding the effectiveness of interventions on HF home management by family caregivers

provides clear direction for the formulation of the research purpose.

Research Purpose Inapublishedstudy,thepurposefrequentlyisreflectedinthetitleofthestudy,statedinthestudyabstract,andrestated

after the literature review. Piamjariyakul and associates (2013) included the purpose of their study in all three places.

The focus of this study was to examine the effectiveness of a telephone coaching program on HF home management

(independent variable) on caregiving burden, confidence in providing HF care, preparedness, satisfaction, and pro-

gram cost (dependent variables) for family caregivers (population). The purpose indicated the type of study con-

ducted (quasi-experimental) and clearly identified the independent variable (telephone coaching program),

population(patientswithHFandtheirfamilies),andsetting(home).However,thedependentvariablesarenotclearly

identified in the study purpose but were discussed in the methods section of the study. The study purpose would have

been strengthened by the inclusion of the dependent variables measured in this study.

Implications for Practice The findings from the study by Piamjariyakul and co-workers (2013, p. 38) indicated that “The telephone coaching

programwas shown to reduce the caregiving burden and improve caregiverconfidence and preparedness in HF home

caremanagement. . . . The costfor the program is considerably less than the costfor home healthcare providers ($120-

160 per eachvisit), a single emergency department visit, or one inpatient hospitalization for HF due to poor HF home

management.” This study has potential for use in practice to improve the quality of care provided to patients and

families; however, the researchers did recognize the need for additional testing of the coaching program with a larger

sample todetermine its effectiveness. Thistype ofstudysupportsthe Quality andSafety Education forNurses (QSEN,

2013; Sherwood & Barnsteiner, 2012) prelicensure competency to ensure safe, quality, and cost- effective health care

that actively involves patients and families in this care process.

132 CHAPTER 5 Research Problems, Purposes, and Hypotheses

IDENTIFYING THE PROBLEM AND PURPOSE IN QUANTITATIVE, QUALITATIVE, AND OUTCOMES STUDIES

Quantitative, qualitative, and outcomes research approaches enable nurses to investigate a variety

of research problems and purposes. Examples of research topics, problems, and purposes for

different types of quantitative, qualitative, and outcomes studies are presented in this section.

Problems and Purposes in Types of Quantitative Studies Example research topics, problems, and purposes for the different types of quantitative research

(descriptive, correlational, quasi-experimental, and experimental) are presented in Table 5-1.

If little is known about a topic, researchers usually start with descriptive and correlational studies

and progress to quasi-experimental and experimental studies as knowledge expands in an area.

An examination of the problemsand purposes in Table 5-1 will revealthe differencesand similarities

among the types of quantitative research. The research purpose usually reflects the type of study that

was conducted (Grove, Burns, & Gray, 2013). The purpose of descriptive research is to identify and

describe concepts or variables, identify possible relationships among variables, and delineate differ-

ences between or among existing groups, such as males and females or different ethnic groups.

TABLE 5-1 QUANTITATIVE RESEARCH

Topics, Problems, and Purposes

TYPE OF

RESEARCH RESEARCH TOPIC RESEARCH PROBLEM AND PURPOSE

Descriptive

research

Hand hygiene (HH),

HH opportunities,

HH adherence,

infection control,

pediatric extended

care facilities (ECFs),

clinical and

nonclinical

caregivers

Title of study: “Hand hygiene opportunities in pediatric extended

care facilities” (Buet et al., 2013, p. 72).

Problem: “The population in pediatric ECFs [extended care

facilities] is increasingly complex, and such children are at high

risk of healthcare-associated infections (HAIs), which are

associated with increased morbidity, mortality, resources use,

and cost (Burns et al., 2010) [problem significance]. . . . The

Centers for Disease Control and Prevention (CDC) . . . and the

World Health Organization (WHO, 2009) have published

evidence-based guidelines confirming the causal relationship

between poor infection control practices, particularly hand

hygiene (HH), and increased risk of HAIs [problem background].

However, most of the HH research has been focused in adult

long term care facilities and acute care settings and findings

from such studies are unlikely to be applicable to HH in pediatric

ECFs given the different care patterns, including the relative

distribution of different devices” [problem statement] (Buet

et al., 2013, pp. 72-73).

Purpose: “The purpose of this observational study was to

assess the frequency and type of HH opportunities initiated by

clinical (e.g., physicians and nurses) and non-clinical

(e.g., parents and teachers) care givers, as well as evaluate

HH adherence using the WHO’s ‘5 Moments for HH’

observation tool” (Buet et al., 2013, p. 73).

Continued

133CHAPTER 5 Research Problems, Purposes, and Hypotheses

TABLE 5-1 QUANTITATIVE RESEARCH—cont’d

TYPE OF

RESEARCH RESEARCH TOPIC RESEARCH PROBLEM AND PURPOSE

Correlational

research

Insulin resistance;

anthropometric

measurements

(height, weight, body

mass index [BMI],

and waist

circumference);

systolic and diastolic

blood pressure;

laboratory values of

lipids and

triglycerides; and

inflammatory marker

high-sensitivity C-

reactive protein

(hsCRP)

Title of study: “Biological correlates and predictors of insulin

resistance among early adolescents” (Bindler et al., 2013,

p. 20).

Problem: “Prevalence of obesity is at historic high levels among

youth; for example, worldwide, obesity has doubled, and in

developed countries, the numbers of youth who are overweight

or obese have tripled in the last three decades (WHO, 2011)

[problem significance]. . . . Youth with obesity and insulin

resistance (IR) are at increased risk of associated chronic

conditions in adulthood, such as elevated blood pressure (BP),

cardiovascular disease (CVD), type 2 diabetes, and several

types of cancer (Li et al., 2009) [problem background].

Despite the known relationships between IR and

cardiometabolic factors, no study has yet examined the

independent effects of these factors on a predictive model of IR

among early adolescents” [problem statement] (Bindler et al.,

2013, pp. 20-21).

Purpose: “Therefore, the purposes of this study among a group

of early adolescents participating in the Teen Eating and Activity

Mentoring in Schools (TEAMS) study were to describe the

anthropometric and laboratory markers of the participants and

to test the ability of these markers to predict risk of exhibiting

IR” (Bindler et al., 2013, p. 21).

Quasi-

experimental

research

Nurse-case-managed

intervention,

hepatitis A and B

vaccine completion,

sociodemographic

factors, risk

behaviors, and

homeless adults

Title of study: “Effects of a nurse-managed program on hepatitis

A and B vaccine completion among homeless adults”

(Nyamathi et al., 2009, p. 13).

Problem: “Hepatitis B virus (HBV) infection poses a serious threat

to public health in the United States. Recent estimates place

the true prevalence of chronic HBV in the United States at

approximately 1.6 cases per 100,000 persons (CDC, 2008). It is

estimated that there were 51,000 new cases of HBV infection

in 2005 (Wasley et al., 2007), a financial burden reaching $1

billion annually. . . . Homeless populations are at particularly high

risk of HBV infection due to high rates of unprotected sexual

behavior and sharing of needles and other IDU [injection drug

user] paraphernalia. Previous studies have reported that HBV

infection rates among homeless populations range from 17% to

31% (i.e., from 17,000 to 31,000 per 100,000) compared with

2.1 per 100,000 in the general United States population

[problem significance]. . . . Vaccination is the most effective way

to prevent HBV infection (CDC, 2006). . . . Improving vaccination

adherence rates among homeless persons is an important step

toward reducing the high prevalence of HBV infection in this

population [problem background]. . . . Thus, little is known about

adherence to HBV vaccination among community samples of

urban homeless person[s] or about the effect of stronger

134 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Buet and co-workers (2013) conducted a descriptive study to identify the hand hygiene (HH)

opportunities and adherence among clinical and nonclinical caregivers in extended pediatric care

facilities. These researchers followed the World Health Organization “5 Moments for Hand

Hygiene” (WHO, 2009): before touching a patient, before clean or aseptic procedures, after body

fluid exposure or risk, after touching a patient, and after touching patient surroundings.

Researchers found that HH opportunities were numerous for clinical and nonclinical caregivers,

but adherence to HH was low, especially for nonclinical individuals. This study supports the

importance of HH in the delivery of quality, safe care based on current evidence-based guidelines

(Melnyk & Fineout-Overholt, 2011; QSEN, 2013).

TABLE 5-1 QUANTITATIVE RESEARCH—cont’d

TYPE OF

RESEARCH RESEARCH TOPIC RESEARCH PROBLEM AND PURPOSE

interventions to incorporate additional strategies, such as nurse

case management and targeted HBV education along with

client tracking [problem statement]” (Nyamathi et al., 2009,

pp. 13-14).

Purpose: The purpose of this study was to determine the

“effectiveness of a nurse-case-managed intervention

compared with that of two standard programs on completion of

the combined hepatitis A virus (HAV) and HBV vaccine series

among homeless adults and to assess sociodemographic

factors and risk behaviors related to the vaccine completion”

(Nyamathi et al., 2009, p. 13).

Experimental

research

Chronic widespread

pain, aerobic

exercise, analgesia,

neurotrophin-3

synthesis, pain

management,

animal model

Title of study: “Aerobic exercise alters analgesia and

neurotrophin-3 [NT-3] synthesis in an animal model of chronic

widespread pain” (Sharma et al., 2010, p. 714).

Problem: “Chronic widespread pain is complex and poorly

understood and affects about 12% of the adult population in

developed countries (Rohrbeck et al., 2007) [problem

significance]. . . . Management of chronic pain syndromes

poses challenges for healthcare practitioners, and

pharmacological interventions offer limited efficacy. . . .

Exercise training has been long suggested to reduce pain and

improve functional outcomes (Whiteside et al., 2004) [problem

background]. . . . Surprisingly, the current literature is mainly

limited to human studies where the molecular basis for exercise

training cannot be easily determined. Relatively few animal

studies have addressed the effects and mechanisms of

exercise on sensory modulation of chronic pain” [problem

statement] (Sharma et al., 2010, p. 715).

Purpose: “The purpose of the present study was to examine the

effects of moderate-intensity aerobic exercise on pain-like

behavior and NT-3 in an animal model of widespread pain”

(Sharma et al., 2010, p. 714).

135CHAPTER 5 Research Problems, Purposes, and Hypotheses

The purpose of correlational research is to examine the type (positive or negative) and strength

of relationships among variables. In their correlational study, Bindler, Bindler, and Daratha (2013)

examined the prediction of insulin resistance (IR) in adolescents using anthropometric measure-

ments (height, weight, body mass index [BMI], and waist circumference), systolic and diastolic

blood pressure, laboratory values [lipid and triglyceride levels], and the inflammatory marker

of high-sensitivity, C-reactive protein (see Table 5-1). The researchers found that waist circumfer-

ence and triglycerides were the strongest predictors of IR in adolescents. The findings from this

study stressed the importance of nurses measuring waist circumference, height, and weight; cal-

culating BMI; and examining lipid levels to identify youths at risk for IR.

Quasi-experimental studies are conducted to determine the effect of a treatment or indepen-

dent variable on designated dependent or outcome variables (Shadish, Cook, & Campbell, 2002).

Nyamathi and colleagues (2009) conducted a quasi-experimental study to examine the effective-

ness of a nurse case-managed intervention on hepatitis A and B vaccine completion among home-

less adults. The research topics, problem, and purpose for this study are presented in Table 5-1. The

findings from this study “revealed that a culturally sensitive comprehensive program, which

included nurse case management plus targeted hepatitis education, incentives, and client tracking,

performed significantly better than did a usual care program” (Nyamathi et al., 2009, p. 21). Thus

the researchers recommended that public health program planners and funders use this type of

program to promote increased completion of hepatitis A and B vaccinations for high-risk groups.

Experimental studies are conducted in highly controlled settings, using a highly structured

design to determine the effect of one or more independent variables on one or more dependent

variables (Grove et al., 2013). Sharma, Ryals, Gajewski, and Wright (2010) conducted an experi-

mental study to determine the effects of an aerobic exercise program on pain like behaviors and

neurotrophin-3 synthesis in mice with chronic widespread pain (see Table 5-1). These researchers

found that moderate-intensity aerobic exercise had the effect of deep tissue mechanical hyperal-

gesia on chronic pain in mice. This finding provides a possible molecular basis for aerobic exercise

training in reducing muscular pain in fibromyalgia patients.

Problems and Purposes in Types of Qualitative Studies The problems formulated for qualitative research identify areas of concern that require investiga-

tion to gain new insights, expand understanding, and improve comprehension of the whole

(Munhall, 2012). The purpose of a qualitative study indicates the focus of the study, which

may be a concept such as pain, an event such as loss of a child, or a facet of a culture such as

the healing practices of a specific Native American tribe. In addition, the purpose often indicates

the qualitative approach used to conduct the study. The basic assumptions for this approach are

discussed in the research report (Creswell, 2014). Examples of research topics, problems, and pur-

poses for the types of qualitative research—phenomenological, grounded theory, ethnographic,

exploratory-descriptive, and historical—commonly found in nursing are presented in Table 5-2.

Phenomenological research is conducted to promote a deeper understanding of complex

human experiences as they have been lived by the study participants (Munhall, 2012).

Trollvik, Nordbach, Silen, and Ringsberg (2011) conducted a phenomenological study to describe

children’s experiences of living with asthma. The research topics, problem, and purpose for this

study are presented in Table 5-2. Findings from this study described two themes with five sub-

themes (identified in parentheses): fear of exacerbation (body sensations, frightening experiences,

and loss of control) and fear of being ostracized (experiences of being excluded and dilemma of

keeping the asthma secret or being open about it). The findings from this study emphasize that

asthma management is not only a major issue for the children involved but also for their parents,

136 CHAPTER 5 Research Problems, Purposes, and Hypotheses

TABLE 5-2 QUALITATIVE RESEARCH

Topics, Problems, and Purposes

TYPE OF

RESEARCH RESEARCH TOPIC RESEARCH PROBLEM AND PURPOSE

Phenomenological

research

Lived experience

of children,

asthma, health

promotion, child

health, chronic

illness, fears of

exacerbations,

fears of being

ostracized

Title of study: “Children’s experiences of living with asthma: Fear of

exacerbations and being ostracized” (Trollvik et al., 2011, p. 295).

Problem: “Asthma is the most common childhood disease and

long-term medical condition affecting children (Masoli et al.,

2004). The prevalence of asthma is increasing, and atopic

diseases are considered to be a worldwide health problem and an

agent of morbidity in children significance]. . . . Studies show that

children with asthma have more emotional/behavioral problems

than healthy children. . . It has also been found that asthma control

in children is poor and that healthcare professionals (HCPs) and

children focus on different aspects of having asthma (Price et al.,

2002) [problem background]. . . . Few studies have considered

very young children’s, 7-10 years old, perspectives; this study

might contribute to new insights into their lifeworld experiences”

[problem statement] (Trollvik et al., 2011, pp. 295-296).

Purpose: “The aim of this study was to explore and describe

children’s everyday experiences of living with asthma to tailor an

Asthma Education Program based on their perspectives. . . . In

this study, a phenomenological and hermaneutical approach was

used to gain an understanding of the children’s lifeworld” (Trollvik

et al., 2011, p. 296).

Grounded theory

research

Foster care,

pregnancy

prevention,

prevention of

sexually

transmitted

infections,

patient-provider

relationship

Title of study: “Where do youth in foster care receive information

about preventing unplanned pregnancy and sexually transmitted

infections [STIs]” (Hudson, 2012, p. 443).

Problem: “Within the United States, approximately 460,000

children live in foster care, and adolescents comprise half of this

population. . . . Children enter the foster care system as a result of

sexual abuse, physical abuse, or physical neglect and

abandonment (Child Welfare League of America, 2007) [problem

significance]. . . . With limited access to health promotion

information and education about high-risk sexual behavior, it is not

surprising that these young people have a high incidence of

unplanned pregnancy and STIs compared with youth not in foster

care [problem background]. Little research exists on the extent to

which foster youth receive information about sexual activity from

healthcare providers” [problem statement] (Hudson, 2012, p.

443-444).

Purpose: A grounded theory study was conducted to “describe

how and where foster youth receive reproductive health and risk

reduction information to prevent pregnancy and sexually

transmitted infections. Participants also were asked to describe

their relationship with their primary healthcare provider while they

were in foster care” (Hudson, 2012, p. 443).

Continued

137CHAPTER 5 Research Problems, Purposes, and Hypotheses

TABLE 5-2 QUALITATIVE RESEARCH—cont’d

TYPE OF

RESEARCH RESEARCH TOPIC RESEARCH PROBLEM AND PURPOSE

Ethnographic

research

Critical illness,

mechanical

ventilation,

weaning, family

presence,

surveillance

Title of study: “Family presence and surveillance during

weaning from prolonged mechanical ventilation” (Happ et al.,

2007, p. 47).

Problem: “During critical illness, mechanical ventilation imposes

physical and communication barriers between family members

and their critically ill loved ones [problem signicance]. . . . Most

studies of family members in the intensive care unit (ICU) have

focused on families’ needs for information, access to the patient,

and participation in decisions to withdraw or withhold life-

sustaining treatment. . . . Although numerous studies have been

conducted of patient experiences with short- and long-term

mechanical ventilation (LTMV), research has not focused on

family interactions with patients during weaning from mechanical

ventilation [problem background]. Moreover, the importance of

family members’ bedside presence and clinicians’ interpretation

of family behaviors at the bedside have not been critically

examined” [problem statement] (Happ et al., 2007, pp. 47-48).

Purpose: “With the use of data from an ethnographic study of

the care and communication processes during weaning from

LTMV, we sought to describe how family members interact

with the patients and respond to the ventilator and associated

ICU bedside equipment during LTMV weaning” (Happ et al.,

2007, p. 48).

Exploratory-

descriptive

qualitative

research

Intimate partner

violence, abuse

of spouse,

supporting

mothering,

parent-child

relationships,

family health,

providers’

perspective,

social support

Title of study: “Supporting mothering: Service providers’

perspectives of mothers and young children affected by intimate

partner violence” (Letourneau et al., 2011, p. 192).

Problem: “Estimates of the percent of women with exposure to

intimate partner violence (IPV) over their lifetimes by husbands,

partners, or boyfriends range between 8% and 66%. . . . The high

concentration of preschool-age children in households where

women experience IPV. . . is a major concern [problem

significance]. . . . Indeed, preschool-age children exposed to IPV

may share many of the adjustment difficulties experienced by

victims of direct physical and psychological abuse (Litrownik et al.,

2003) [problem background]. The degree to which children

from birth to 36 months of age are affected by IPV, however, is

not well understood. Even less is known of effective services

and supports that target mothers and their young children

exposed to IPV” [problem statement] (Letourneau et al.,

2011, p. 193).

Purpose: “We conducted a qualitative descriptive study of service

providers’ understandings of the impact of IPV on mothers, young

children (birth to 36 months), and mother-infant/child

relationships, and of the support needs of these mothers and

young children” (Letourneau et al., 2011, p. 192).

138 CHAPTER 5 Research Problems, Purposes, and Hypotheses

teachers, and healthcare providers. Asthma educational programs need to be tailored to the indi-

vidual child based on her or his perspectives and needs. This type of knowledge provides direction

for accomplishing the QSEN (2013) competencies of providing patient-centered care.

In grounded theory research, the problem identifies the area of concern and the purpose indi-

cates the focus of the theory to be developed to account for a pattern of behavior of those involved

in the study (Wuest, 2012). For example, Hudson (2012, p. 443) conducted a grounded theory

study to “describe how and where foster youth receive reproductive health and risk reduction

information to prevent pregnancy and sexually transmitted infections (STIs)” (see Table 5-2).

The following three thematic categories emerged from this study: “(a) discomfort visiting and dis-

closing, (b) receiving and not receiving the bare essentials, and (c) learning from community

others” (Hudson, 2012, p. 445). The implications for practice were that primary care providers

needed to provide time and confidential space for foster youths to disclose their sexual activities,

and they (foster youths) need to receive more reproductive and risk prevention information from

their school settings.

In ethnographic research, the problem and purpose identify the culture and specific attributes

of the culture that are to be examined, described, analyzed, and interpreted to reveal the social

actions, beliefs, values, and norms of the culture (Wolf, 2012). Happ, Swigart, Tate, Arnold,

Sereika, and Hoffman (2007) conducted an ethnographic study of family presence and surveillance

during weaning of their family member from a ventilator. Table 5-2 includes the research topics,

problem, and purpose of this study. They concluded that “this study provided a potentially useful

conceptual framework of family behaviors with long-term critically ill patients that could enhance

TABLE 5-2 QUALITATIVE RESEARCH—cont’d

TYPE OF

RESEARCH RESEARCH TOPIC RESEARCH PROBLEM AND PURPOSE

Historical research Health disparities,

childhood

obesity, historical

exemplar,

prevention of

infant mortality,

public health

nurses’ role

Title of study: “Nurses’ role in the prevention of infant mortality in

1884-1925: Health disparities then and now (Thompson &

Keeling, 2012, p. 471).

Problem: “Over the past several years, health policy makers have

directed increased attention to issues of health disparities, an

issue that has concerned the nursing profession for over a century

[problem significance]. . . . Reutter and Kushner (2010) advocate

that addressing health inequities are well within the nursing

mandate and yet is an underutilized role [problem background]. . . .

Nursing historical research lends insight into the complex health

issues that nurses face today and may guide policy and nursing

practice [problem statement]” (Thompson & Keeling, 2012,

p. 471).

Purpose: The purpose of this historical study “was to evaluate the

public health nurses’ (PHNs’) role with infant mortality during

1884-1925, specifically how nursing care impacted on conditions

of poverty, poor nutrition, poor living conditions, lack of education,

and lack of governmental policies that contributed to the poor

health of infants a century ago” (Thompson, & Keeling, 2012,

p. 471).

139CHAPTER 5 Research Problems, Purposes, and Hypotheses

the dialogue about family-centered care and guide future research on family presence in the inten-

sive care unit” (Happ et al., 2007, p. 47).

Exploratory-descriptive qualitative research is being conducted by several qualitative

researchers to describe unique issues, health problems, or situations that lack clear description

or definition. This type of research often provides the basis for future qualitative and quantitative

research (Creswell, 2014; Grove et al., 2013). Letourneau, Young, Secco, Stewart, Hughes, and

Critchley (2011) conducted an exploratory-descriptive qualitative study of service providers’

understandings of the impact of intimate partner violence (IPV) on mothers and their young chil-

dren to determine their needs for support (see Table 5-2). They found that these mothers and their

children require more support than is currently available. In addition, the service providers had

difficulty identifying interventions to promote and protect them and their children.

The problem and purpose in historical research focus on a specific individual, characteristic of

society,event,orsituationinthepastandusuallyidentifythetimeperiodinthepastthatwasexamined

by thestudy(Lundy,2012).Forexample,ThompsonandKeeling(2012)examinedtheroleofthepub-

lic health nurse (PHN) in the prevention of infant mortality from 1884 to 1925 (see Table 5-2). They

emphasizedthatstudyingthepastroleofPHNsandthehealthdisparitiesthenandnowwouldincrease

our understanding of current nursing practice with regard to childhood health issues. They provided

the following suggestions for nursing practice: “focus on health disparities in childhood obesity, in

areas of environmental and policy change, and the development of social programs and education

for families to support healthier living” (Thompson & Keeling, 2012, p. 471).

Problems and Purposes in Outcomes Research Outcomes research is conducted to examine the end results of care (Doran, 2011). This is a grow-

ing area of research in nursing to examine the relationships between the nursing process of care and

patient outcomes. Table 5-3 includes the topics, problem, and purpose from an outcomes study by

Ausserhofer and associates (2013), who explored the relationship between patient safety climate

(PSC) and selected patient outcomes in Swiss acute care hospitals. The adverse events or outcomes

examined were medication errors, patient falls, pressure ulcers, and healthcare-associated infec-

tions that are common problems in U.S. hospitals (Institute of Medicine, 2004). This study was

guided by a common outcomes framework that focused on structure or work system, process

of care, and patient outcomes (see Chapter 14). These researchers did not find a significant rela-

tionship of PSC to the selected patient outcomes. However, they stressed the need for additional

research in this area and for selecting more reliable outcome measures.

DETERMINING THE SIGNIFICANCE OF A STUDY PROBLEM AND PURPOSE

A research problem is significant when it has the potential to generate or refine relevant knowledge

that directly or indirectly affects nursing practice (Brown, 2014). When critically appraising the

significance of the problem and purpose in a published study, you need to determine whether

the knowledge generated in the study (1) influences nursing practice, (2) builds on previous

research, (3) promotes theory testing or development, and/or (4) addresses current concerns or

priorities in nursing (Grove et al., 2013).

Influences Nursing Practice Studies that address clinical concerns and generate findings to improve nursing practice are consid-

ered significant. These types of practice-focused studies often have the potential to improve the

140 CHAPTER 5 Research Problems, Purposes, and Hypotheses

quality of nursing care provided, promote healthy patient and family outcomes, decrease morbidity

and mortality, and reduce the costs of care. The ultimate goal is providing evidence-based practice

(EBP) so that nursing care is based on the most current research (Brown, 2014; Melnyk & Fineout-

Overholt, 2011). Several research problems and purposes have focused on the effects of nursing

interventions or on ways to improve these interventions. In a study noted earlier, Piamjariyakul

and co-workers (2013) determined the effectiveness of a telephone coaching program on heart

failure (HF) management in the home by family caregivers. The intervention for this study was

developed using the evidence-based national clinical guidelines for management of HF.

Intervention-focused studies generate significant empirical knowledge that promotes the develop-

ment of EBP and the delivery of quality, safe patient- and family-centered care (QSEN, 2013;

Sherwood & Barnsteiner, 2012).

Builds on Previous Research A significant study problem and purpose are based on previous research. In a research article, the

introduction and literature review sections include relevant studies that provide a basis for the

current study. Often, a summary of the current literature indicates what is known and not known

in the area being studied (see Chapter 6). The gaps in the current knowledge base provide support

TABLE 5-3 OUTCOMES RESEARCH

Topics, Problem, and Purpose

TYPE OF

RESEARCH RESEARCH TOPIC RESEARCH PROBLEM AND PURPOSE

Outcomes

research

Work system of patient

safety climate (PSC)

Process of care of

nurses, workload

work, and patient

needs

Outcomes of adverse

events and patient

satisfaction

Title of study: “The association of patient safety climate and nurse-

related organizational factors with selected patient outcomes: A

cross-sectional survey” Ausserhofer et al., 2013, p. 240).

Problem: “Today’s patient care in healthcare organizations is anything

but safe, as between 2.9% and 16.6% of hospitalized patients are

affected by adverse events such as medication errors, healthcare-

associated infection, or patient falls. More than one-third of adverse

events lead to temporary (34%) or permanent disability (6-9%) and

between 3% and 20.8% of the patients experiencing an adverse

event die [problem significance]. . . . As 37-70% of all adverse

events are considered preventable, . . . harmful impacts on patients,

such as psychological trauma, impaired functionality or loss of trust

in the healthcare system as well as socio-economic costs, could be

avoided (Institute of Medicine, 2004). . . . Patient safety climate

(PSC) is an important work environment factor determining patient

safety and quality of care in healthcare organizations [problem

background]. Few studies have investigated the relationship

between PSC and patient outcomes, considering possible

confounding effects of other nurse-related organizational factors

[problem statement]” (Ausserhofer et al., 2013, pp. 240-241).

Purpose: “The purpose of this study was to explore the relationship

between PSC and selected patients outcomes in Swiss acute care

hospitals” (Ausserhofer et al., 2013, p. 242).

141CHAPTER 5 Research Problems, Purposes, and Hypotheses

for and document the significance of the study’s purpose. The study by Piamjariyakul and

colleagues (2013; see earlier) indicated what was known about the effectiveness of management

in the home of HF patients’ outcomes. What was not known was the effectiveness of a telephone

coaching intervention on caregivers’ confidence and skill in managing HF patients in the home and

their caregiving burden. This gap in the research knowledge base provides the basis for developing

a study to examine the effectiveness of an intervention in improving HF patients’ and caregivers’

outcomes.

Promotes Theory Testing or Development Significant problems and purposes in quantitative studies are supported by theory, and often the

focus of these studies is theory testing (Chinn & Kramer, 2011). The focus of qualitative studies is

often on developing theory (Munhall, 2012). A detailed discussion of the different types of theory

tested and/or developed through research is presented in Chapter 7.

Addresses Nursing Research Priorities Over the last 40 years, expert researchers, professional organizations, and funding agencies have iden-

tified research priorities to encourage studies in the most important areas for nursing. The research

priorities for clinical practice were initially identified in a study by Lindeman (1975). Those original

research priorities included nursing interventions related to stress, care of the aged, pain manage-

ment, and patient education, which continue to be priorities for nursing research today.

Many professional nursing organizations use websites to communicate their current research

priorities. For example, the current research priorities of the American Association of Critical-Care

Nurses (AACN, 2013) are identified on the website as:

(1) effective and appropriate use of technology to achieve optimal patient assessment, manage-

ment, and/or outcomes; (2) creation of a healing, humane environment; (3) processes and systems

that foster the optimal contribution of critical care nurses; (4) effective approaches to symptom

management; and (5) prevention and management of complications.

AACN, 2013; http://www.aacn.org/wd/practice/content/research/

research-priority-areas.pcms?menu¼practice AACN (2013) has also identified future research needs under the following topics: medication

management, hemodynamic monitoring, creating healing environments, palliative care and end-

of-life issues, mechanical ventilation, monitoring neuroscience patients, and noninvasive monitor-

ing. You can review these research priorities by going to the AACN website (http://www.aacn.org)

and searching for the research priority areas.

A significant funding agency for nursing research is the National Institute of Nursing Research

(NINR). A major initiative of the NINR is the development of a national nursing research agenda

that involves identifying nursing research priorities, outlining a plan for implementing priority

studies, and obtaining resources to support these priority projects.

To advance the science of health, NINR will invest in research to:

• Enhance health promotion and disease prevention.

• Improve quality of life by managing symptoms of acute and chronic illness.

• Improve palliative and end-of-life care.

• Enhance innovation in science and practice.

• Develop the next generation of nurse scientists.

NINR, 2011; http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan

142 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Another federal agency with emphasis on funding healthcare research is the Agency for Health-

care Research and Quality (AHRQ). The mission for AHRQ is “to improve the quality, safety, effi-

ciency,and effectiveness of health careforall Americans” (AHRQ, 2013). The researchpriorities and

funded projects are presented on the AHRQ website (http://www.ahrq.gov/legacy/fund/ragendix.

htm). These are important areas for nursing and the focus of the QSEN (2013) competencies for

undergraduate nursing students, which include the areas of patient-centered care, teamwork and

collaboration, EBP, quality improvement, safety, and informatics. The research generated through

AHRQ will provide sound evidence for providing quality and safe care in nursing.

World Health Organization (WHO) is encouraging the identification of priorities for a common

nursing research agenda among countries. A quality healthcare delivery system and improved

patient and family health have become global goals. By 2020, the world’s population is expected

to increase by 94%, with the older adult population increasing by almost 240%. Seven of every

10deathsareexpectedtobecausedbynoncommunicable diseases,suchaschronicconditions(heart

disease, cancer, depression) and injuries (unintentional and intentional). The priority areas for

research identified by WHO are to:

(1) improve the health of the world’s most marginalized populations; (2) study new diseases that

threaten public health around the world; (3) conduct comparative analyses of supply and

demand of the health workforce of different countries; (4) analyze the feasibility, effectiveness,

and quality of education and practice of nurses; (5) conduct research on healthcare delivery

modes; and (6) examine the outcomes for healthcare agencies, providers, and patients around

the world.

WHO, 2013; http://www.who.int/entity/en.

The Healthy People 2020 website identifies and prioritizes the health topics and objectives of all

age groups over the next decade (U.S. Department of Health and Human Services [U.S. DHHS],

2013). These health topics and objectives direct future research in the areas of health promotion,

illness prevention, illness management, and rehabilitation and can be accessed online (http://www.

healthypeople.gov/2020/topicsobjectives2020/default.aspx).

In summary, expert nurse researchers, professional nursing organizations, and national and

international agencies and organizations have identified research priorities to direct the future

conduct of healthcare research to improve the outcomes for patients and families, nurses, and

healthcare systems. When conducting a critical appraisal of a study, you need to examine the

study’s contribution to nursing practice and determine whether the study’s problem and purpose

are based on previous research, theory, and current research priorities. These four elements help

determine a study’s significance in developing and refining knowledge to build an EBP for nursing

(Brown, 2014).

EXAMINING THE FEASIBILITY OF A PROBLEM AND PURPOSE

A critical appraisal of research begins by determining the feasibility of the problem and purpose of

the study. The feasibility of a study is determined by examining the researchers’ expertise; money

commitment; availability of subjects, facilities, and equipment; and the study’s ethical consider-

ations (Rogers, 1987). The feasibility of Piamjariyakul and associates’ (2013) study of the effective-

ness of a telephone coaching program on heart failure (HF) home management by family

caregivers was critically appraised and presented as an example as follows. You can review the prob-

lem and purpose for this study presented at the beginning of this chapter. The critical appraisal

involves addressing the following questions about a study’s feasibility.

143CHAPTER 5 Research Problems, Purposes, and Hypotheses

Researcher Expertise The research problem and purpose studied need to be within the area of expertise of the

researchers. Research reports usually identify the education of the researchers and their current

positions, which indicate their expertise to conduct a study. Also, examine the reference list to

determine whether the researchers have conducted additional studies in this area. If you need more

information, you can search the Internet for the researchers’ accomplishments and involvement in

research (Grove et al., 2013).

Piamjariyakul is a PhD-prepared nurse employed by the School of Nursing at the University of

Kansas Medical Center. The reference list includes additional publications by this author in the

area of HF patient management in the home by family caregivers. Thus Piamjariyakul has the

research, education, and academic position that support her expertise to conduct this study. Smith

is also PhD-prepared and is on the faculty at the School of Nursing and Department of Preventive

Medicine and Public Health at the University of Kansas Medical Center. She is an author of pre-

vious publications with Piamjariyakul. Russell, Werkowitch, and Elyachar demonstrate clinical

expertise with certifications in their clinical areas and are employed by the University of Kansas

Medical Center. Piamjariyakul and her co-authors demonstrate strong research, educational,

and clinical expertise for conducting this study.

Money Commitment The problem and purpose studied are influenced by the amount of money available to the

researchers. The cost of a research project can range from a few dollars for a student’s small study

to hundreds of thousands and even millions of dollars for complex projects. Critically appraising a

study involves examining the financial resources available to the researchers in conducting their

study. Sources of funding for a study usually are identified in the article.

Studies might be funded by grants from national institutions, professional organizations, or

private foundations. The researchers may have received financial assistance from companies that

provided necessary equipment or support from the agency where they work. Receiving funding for

a study indicates that it was reviewed by peers who chose to support the research financially.

Piamjariyakul and co-workers’ (2013) study was supported by an award from the American Asso-

ciation of Heart Failure Nurses (AAHFN), a Bernard Saperstein Caregiver Grant, and partially by

the National Heart, Lung, and Blood Institute (NHLBI). This study had strong financial support

from a variety of national funding sources.

Availability of Subjects, Facilities, and Equipment Researchers need to have adequate sample size, facilities, and equipment to implement their study.

Most published studies indicate the sample size and setting(s) in the methods section of the

research report. Often, nursing studies are conducted in natural or partially controlled settings,

? CRITICAL APPRAISAL GUIDELINES Examining Feasibility of Study’s Problem and Purpose

1. Did the researchers have the research, clinical, and educational expertise to conduct the study?

2. Was the study funded by local or national organizations or agencies? Did clinical agencies provide support for

the study?

3. Did the researchers have adequate subjects, settings, and equipment to conduct their study?

4. Was the purpose of the study ethical?

144 CHAPTER 5 Research Problems, Purposes, and Hypotheses

such as a home, hospital unit, or clinic. Many of these facilities are easy to access, and the hospitals

and clinics provide access to large numbers of patients. Piamjariyakul and colleagues (2013, p. 33)

conducted a pilot study with a sample of 12 caregivers who “were recruited from a group of HF

patients receiving care at a large Midwestern University Medical Center.” They recognized the small

sample size as a study limitation but the findings were significant, in that the telephone coaching

program reduced the caregivers’ burden. Thus the researchers recommended that the intervention

be tested with a larger sample to determine its efficacy.

A review of the methods section of the research article will determine if adequate and accurate

equipment was available. Nursing studies frequently require a limited amount of equipment, such

as a tape or video recorder for interviews, or physiological instruments, such as an electrocardio-

graph or thermometer. Piamjariyakul and associates (2013) gave each family caregiver program

materials from American Heart Association handouts and the caregivers’ guidebook, The Comfort

of Home TM

for Chronic Heart Failure: A Guide for Caregivers. The handouts and book were used

during the telephone coaching sessions provided by five nurse interventionists, who had received

training to ensure the fidelity of the intervention implementation.

Ethical Considerations The purpose selected for investigation must be ethical, which means that the subjects’ rights and

the rights of others in the setting are protected (Grove et al., 2013). An ethical study confers more

benefits than risks in its conduct and will generate useful knowledge for practice (see Chapter 4).

Piamjariyakul and co-workers (2013) provided a detailed discussion of the ethical aspects of their

study in the following:

EXAMINING RESEARCH OBJECTIVES, QUESTIONS, AND HYPOTHESES IN RESEARCH REPORTS

Research objectives, questions, and hypotheses evolve from the problem, purpose, literature

review, and study framework, and direct the remaining steps of the research process. In a published

study, the objectives, questions, or hypotheses usually are presented after the literature review sec-

tion and right before the methods section. The content in this section is provided to assist you in

identifying and critically appraising the objectives, questions, and hypotheses in published studies.

Research Objectives or Aims A research objective or aim is a clear, concise, declarative statement expressed in the present tense.

The objectives are sometimes referred to as aims and are generally used in descriptive and corre-

lational quantitative studies. For clarity, an objective or aim usually focuses on one or two variables

and indicates whether they are to be identified or described. Sometimes the purpose of objectives is

to identify relationships among variables or determine differences between two or more existing

groups regarding selected variables.

“The procedures for the study were approved by the university medical center Institutional Review Board

(IRB). All individually identifiable information collected during the study was handled confidentially in accor-

dance with university IRB policies and in compliance with HIPAA [Health Insurance Portability and Account-

ability Act] regulations. Consent was obtained from caregivers and nurse interventionists as well as the

patients for medical record review of demographic data.” Piamjariyakul et al., 2013, p. 34

145CHAPTER 5 Research Problems, Purposes, and Hypotheses

Qualitative research is most appropriatewhen the focus of the study is toobtain a personal perspec-

tive of a situation, experience, or event (Hale, Treharne, & Kitas, 2007). The research objectives or aims

formulated for quantitative and qualitative studies have some similarities because they focus on explo-

ration, description, and determination of relationships. However, the objectives directing qualitative

studies are commonly broader in focus and include concepts that are more complex and abstract than

those of quantitative studies. The aims or objectives in qualitative studies focus on obtaining a holistic,

comprehensive understanding of the area of study (Creswell, 2014; Munhall, 2012).

Tenfelde, Finnegan, Miller, and Hill (2012) used aims to direct their study of the risk of

breastfeeding cessation among low-income women, infants, and children. This correlational

study demonstrated the logical flow from research problem and purpose to research aims used

to guide this study. The questions in the following box were used to conduct a critical appraisal

of this study.

? CRITICAL APPRAISAL GUIDELINES Research Objectives and Questions

1. Are the objectives (aims) or questions clearly and concisely expressed in the study?

2. Are the study aims or questions based on the study purpose?

3. Do the aims or questions appear to direct the study methodology and interpretation of results?

RESEARCH EXAMPLE

Problem, Purpose, and Aims

Research Study Excerpt Research Problem

“A major goal of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is to

improve the nutritional status of infants. . . . On the basis of the scientific evidence supporting breastfeeding

and the use of mother’s milk, mothers who received WIC services are encouraged to breastfeed their infants,

unless medically contraindicated (Gartner et al., 2005). In a national sample of WIC recipients, only 26%

breastfed until 6 months and 12% breastfed until 12 months. . . . These breastfeeding duration rates fall well

below the Healthy People 2020 benchmarks of 61% at 6 months and 34% at 12 months postpartum (U.S.

DHHS, 2010) [problem significance].

Breastfeeding protects infants and mothers against a broad spectrum of adverse health outcomes,

including gastrointestinal infections, ear infections, diabetes, and obesity (Gartner et al., 2005). . . . Mothers

who breastfeed for longer periods are less likely to retain pregnancy weight gain [problem background]. . . .

Although predictors of early breastfeeding cessation among low-income women have been identified in

previous studies, studies focusing solely on WIC participants were limited. Moreover, in no studies were

statistical methods used that enabled identification of the timing of breastfeeding cessation in relation to

specific maternal background and intrapersonal variables” [problem statement] (Tenfelde et al., 2012,

pp. 86-87).

Research Purpose “The purpose of this study was to identify the maternal background and intrapersonal predictors associated

with the timing of breastfeeding cessation in WIC participants over the course of 12-month

postpartum period” (Tenfelde et al., 2012, p. 87).

Research Objectives “Study aims were to determine (a) the risk of breastfeeding cessation over time and (b) how the risk of

breastfeeding cessation varied in relation to maternal background and intrapersonal variables” (Tenfelde

et al., 2012, p. 87).

146 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Research Questions A research question is a clear, concise interrogative statement that is worded in the present tense,

includes one or more variables, and is expressed to guide the implementation of studies. The foci of

research questions in quantitative studies are description of variable(s), examination of relation-

ships among variables, use of independent variables to predict dependent variable, and determi-

nation of differences between two or more groups regarding selected variable(s). These research

questions are usually narrowly focused and inclusive of the study variables and population. It

is really a matter of choice whether researchers identify objectives or questions in their study

but, more often, questions are stated to guide studies. Piamjariyakul and co-workers (2013) con-

ducted a pilot study to examine the feasibility of a telephone coaching program on HF home man-

agement for family caregivers. The problem and purpose for this study were noted earlier. They

identified research questions to direct the implementation of their study. The critical appraisal

guidelines for examining research objectives or questions in a study were applied to this example.

Critical Appraisal Tenfelde and colleagues (2012) identified a significant problem of the low breastfeeding rates and early cessation of

breastfeeding among WIC participants. Their breastfeeding rates for 6 and 12 months were significantly lower than

the Healthy People 2020 benchmarks. The problem background clearly identified the contributions of breastfeeding

to the health of infants and mothers. The problem statement indicated what was not known and provided a basis for

the purpose and aims of this study. The purpose clearly indicated the focus of the study was to identify maternal

background and intrapersonal predictors related to breastfeeding cessation in a population of WIC participants. The

study aims built on the problem and purpose and provide more clarity regarding the focus of the study. The first

study aim focused on describing risk of breastfeeding cessation over time and the second aim focused on relation-

ships of maternal background and intrapersonal variables to risk of breastfeeding cessation. This study identified a

significant problem and a feasible purpose for research. In addition, the study aims provided clear direction for the

conduct of the study and the interpretation of the study results.

Implications for Practice In the following study excerpt, Tenfelde and associates (2012) identified key findings and made recommendations

for practice and research.

“Similar to national findings, the WIC participants in this study did not reach the Healthy People 2020 goals for

breastfeeding duration. Women who had consistently high monthly risks of breastfeeding cessation were

younger, were not of Mexican descent, had no previous breastfeeding experience, and had no breastfeeding

support systems. . . . Clinicians and researchers can use the findings from this study to develop interventions

that are targeted to periods of greatest risk of premature breastfeeding cessation to prolong breastfeeding

duration in this vulnerable population” (Tenfelde et al., 2012, p. 93).

RESEARCH EXAMPLE

Questions from a Quantitative Study

Research Study Excerpt Research Questions

“The research questions were:

1. Did the family caregivers completing the program and nurse interventionists implementing the coaching

program evaluate the program as helpful for HF home management?

2. Were there improvements in outcomes data for caregivers’ level of HF caregiving burden, confidence, and

preparedness in providing HF home care?

3. What were the costs of the program materials and delivery?” Piamjariyakul et al., 2013, p. 33. Continued

147CHAPTER 5 Research Problems, Purposes, and Hypotheses

The research questions directing qualitative studies are often limited in number, broadly

focused, and inclusive of variables or concepts that are more complex and abstract than those

of quantitative studies. Marshall and Rossman (2011) indicated that the questions developed to

direct qualitative research might be theoretical, which can be studied with different populations

or in a variety of sites, or the questions could be focused on a particular population or setting. The

specific study questions formulated are very important for the selection of the qualitative research

method to be used to conduct the study (Hale et al., 2007). Thompson and Keeling (2012) con-

ducted a historical study to examine the PHNs’ role in the prevention of infant mortality from

1884 to 1925. Table 5-2 includes the problem and purpose for this study; the questions used to

guide this study are presented in the following study excerpt.

RESEARCH EXAMPLE—cont’d

Critical Appraisal Piamjariyakul and colleagues (2013) clearly stated their problem and purpose, as indicated earlier, and the research

questions build on these and clarified the foci of this study. The first question focuses on description of the quality of

the telephone coaching program from the perspectives of the family caregivers and the nurses. The second question

focuses on differences in outcomes before and after the implementation of the telephone coaching program for the

caregivers. The third question focuses on a description of the costs related to the program. These questions are

addressed by the study methodology and were used to organize the study results.

Implications for Practice The implications for practice for the Piamjariyakul and associates’ (2013) study were discussed earlier.

RESEARCH EXAMPLE

Questions from a Qualitative Study

Research Questions “1. What was the state of the art of medicine and nursing regarding childhood malnutrition in the late 19th

and early 20th century?

2. How did ethnicity and class influence the care given and what were the socioeconomic and political

issues of that time?” Thompson, & Keeling, 2012, p. 472.

Critical Appraisal Thompson and Keeling (2012) identified a significant problem of infant mortality and conducted a historical study

to examine the role of early PHNs on improving understanding of childhood health issues today. The problem state-

ment indicated what was not known and provided the basis for the research purpose (see Table 5-2). The research

questions provided clear direction for the conduct of this qualitative study. Question 1 focused on a description of

nursing and medical practice regarding childhood malnutrition from 1884 to 1925. Question 2 focused on a

description of socioeconomic and political issues of that time. These questions directed the study and the interpre-

tation of the results.

Implications for Practice Thompson and Keeling (2012, p. 477) identified the following implications for practice:

“Nurses made a significant impact on infant mortality a century ago, and today, we can learn from their exam-

ple to do the same for child health issues such as childhood obesity. Nurses and nurse practitioners, partic-

ularly, are an integral part of this fight against obesity in targeting at risk children from disadvantaged

backgrounds who might not otherwise receive optimal care.”

148 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Hypotheses A hypothesis is a formal statement of the expected relationship(s) between two or more variables

in a specified population. The hypothesis translates the research problem and purpose into a clear

explanation or prediction of the expected results or outcomes of selected quantitative and outcome

studies. A clearly stated hypothesis includes the variables to be manipulated or measured, identifies

the population to be examined, and indicates the proposed outcomes for the study. Hypotheses

also influence the study design, sampling method, data collection and analysis process, and inter-

pretation of findings (Fawcett & Garity, 2009). Quasi-experimental and experimental quantitative

studies are conducted to test the effectiveness of a treatment or intervention; these types of studies

should include hypotheses to predict the study outcomes. In this section, types of hypotheses are

described and the elements of a testable hypothesis are discussed so that you can critically appraise

hypotheses in published studies.

Types of Hypotheses Different types of relationships and numbers of variables are identified in hypotheses. A study

might have one, four, or more hypotheses, depending on its complexity. The type of hypothesis

developed is based on the purpose of the study. Hypotheses can be described using four categories:

(1) associative versus causal; (2) simple versus complex; (3) nondirectional versus directional; and

(4) statistical versus research.

Associative versus causal hypotheses. The relationships identified in hypotheses are associa- tive or causal. An associative hypothesis proposes relationships among variables that occur or

exist together in the real world, so that when one variable changes, the other changes

(Reynolds, 2007). Associative hypotheses identify relationships among variables in a study but

do not indicate that one variable causes an effect on another variable. Ausserhofer, Schubert,

Desmedt, Belgen, De Geest, and Schwendimann (2013) used an associative hypothesis to direct

their outcomes study (the problem and purpose for this study are presented in Table 5-3 for your

review). They hypothesized that “higher levels of PSC [patient safety climate] would be associated

with less frequent nurse-reported adverse events (medication errors, patient falls, pressure ulcers,

and healthcare-associated infections) and higher patient satisfaction” (Ausserhofer et al., 2013,

p. 242). This associative hypothesis identified the expected negative relationship between PSC

and nurse-reported adverse events (as PSC increased, adverse events were less frequent) and

the positive relationship between PSC and patient satisfaction (as PSC increased, patient satisfac-

tion was higher). These relationships are diagrammed below:

Patient safety climate (PSC)

Nurse-reported adverse events (e.g., medication errors, falls,

ulcers, infections)

Patient satisfaction

–

+

A causal hypothesis proposes a cause and effect interaction between two or more variables,

referred to as independent and dependent variables. The independent variable (treatment or

experimental variable) is manipulated by the researcher to cause an effect on the dependent or

outcome variable. The researcher then measures the dependent variable to examine the effect cre-

ated by the independent variable (Fawcett & Garity, 2009). A format for stating a causal hypothesis

149CHAPTER 5 Research Problems, Purposes, and Hypotheses

is the following: the subjects in the experimental group, who are exposed to the independent var-

iable (treatment), demonstrate greater change, as measured by the dependent variable, than the

subjects in the comparison group who receive standard care. Bernard and colleagues (2013) con-

ducted a quasi-experimental study to examine the effect of a counseling and exercise intervention

on smoking reduction in patients with schizophrenia. They hypothesized that “the participants

would decrease tobacco consumption at the end of the intervention compared to baseline”

(Bernard et al., 2013, p. 24). The counseling and exercise intervention (independent variable)

was proposed to cause a decrease in tobacco consumption (dependent variable) in patients with

schizophrenia. This causal hypothesis might be diagrammed as follows, with an arrow (!) to indi- cate cause and effect versus association:

Counseling and exercise intervention �!� Decreased tobacco consumption Simple versus complex hypotheses. A simple hypothesis states the relationship (associative or

causal) between two variables. Bernard and co-workers’ (2013) study included a simple causal

hypothesis, with one independent variable and one dependent variable. A complex hypothesis

states the relationships (associative or causal) among three or more variables. Ausserhofer and

colleagues’ (2013) study included a complex associative hypothesis that examined the relationships

between PSC and nurse-reported adverse events (e.g., medication errors, patient falls, pressure

ulcers, healthcare-associated infections) and between PSC and patient satisfaction. These

researchers examined associations or relationships among six variables (PSC, four specific adverse

events or outcomes, and patient satisfaction).

Nondirectional versus directional hypotheses. A nondirectional hypothesis states that a rela- tionship exists but does not predict the nature (positive or negative) of the relationship. If the

direction of the relationship being studied is not clear in clinical practice or in the theoretical

or empirical literature, the researcher has no clear indication of the nature of the relationship.

Under these circumstances, nondirectional hypotheses are developed, such as “hours playing video

games is related to body mass index in school-age children.” This is an example of a simple (two

variables), associative, and nondirectional hypothesis.

A directional hypothesis states the nature (positive or negative) of the interaction between two

or more variables. The use of terms such as positive, negative, less, more, increase, decrease, greater,

higher, or lower in a hypothesis indicates the direction of the relationship. Directional hypotheses

are developed from theoretical statements (propositions), findings of previous studies, and clinical

experience. As the knowledge on which a study is based increases, researchers are able to make a

prediction about the direction of a relationship between the variables being studied. For example,

Ausserhofer and associates (2013, p. 242) stated a directional hypothesis: “that higher levels of PSC

would be associated with less frequent nurse-reported adverse events (medication errors, patient

falls, pressure ulcers, and healthcare-associated infections) and higher patient satisfaction.” The

italicized words indicate the nature of the relationships in this complex, associative, directional

hypothesis. The diagram of this hypothesis (see earlier) indicates that the relationship of PSC

and adverse events is negative and the relationship of PSC and patient satisfaction is positive.

A causal hypothesis predicts the effect of an independent variable on a dependent variable, spec-

ifying the direction of the relationship. The independent variable increases or decreases each

dependent variable. Thus all causal hypotheses are directional. Bernard and co-workers (2013)

conducted a quasi-experimental study to test a simple, causal, directional hypothesis to guide their

study. They predicted that a counseling and exercise intervention would decrease tobacco con-

sumption in patients with schizophrenia. The results of this study were statistically significant,

and this hypothesis was supported at the end of the intervention and at 6 weeks postintervention.

150 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Statistical versus research hypotheses. The statistical hypothesis, also referred to as a null hypothesis (H0), is used for statistical testing and for interpreting statistical outcomes. Even if

the null hypothesis is not stated, it is implied, because it is the converse of the research hypothesis

(Kerlinger & Lee, 2000). Some researchers state the null hypothesis because it is more easily inter-

preted on the basis of the results of statistical analyses. The null hypothesis is also used when the

researcher believes that there is no relationship between two variables and when theoretical or

empirical information is inadequate to state a research hypothesis. A statistical or null hypothesis

can be simple or complex and associative or causal. Schultz, Drew, and Hewitt (2002) conducted a

quasi-experimental study to determine the effectiveness of heparinized and normal saline flushes

in maintaining the patency of 24-gauge (G) intermittent peripheral intravenous (IV) catheters in

neonates in intensive care. “The hypothesis stated that there would be no significant difference in

the duration of patency of a 24-G IV lock in a neonatal patient when flushed with 0.5 mL

[millimeters] of heparinized saline (2 U/mL), our standard practice, compared with 0.5 mL

of 0.9% normal saline” (Schultz et al., 2002, p. 30). This is a simple null hypothesis with one

independent variable (0.9% normal saline flush) and one dependent variable (patency of 24-G

IV catheter). The comparison group received standard care of a heparinized saline flush, and

the population was neonates in an intensive care setting. The findings of the study did not support

the null hypothesis because the catheters flushed with heparinized saline were patent significantly

longer than the catheters flushed with normal saline. Thus the researchers recommended continu-

ing the use of heparinized saline as the standard for flushing 24-G catheters in infants, which is the

current practice.

A research hypothesis is the alternative hypothesis (H1 or HA) to the null or statistical hypoth-

esis and states that a relationship exists between two or more variables. All the hypotheses stated

earlier in this chapter have been research hypotheses. Research hypotheses can be simple or com-

plex, nondirectional or directional, and associative or causal.

? CRITICAL APPRAISAL GUIDELINES Hypotheses in Studies

1. Are the hypotheses formally stated in the study? If the study is quasi-experimental or experimental, hypoth-

eses are needed to direct the study.

2. Do the hypotheses clearly identify the relationships among the variables of the study?

3. Are the hypotheses associative or causal, simple or complex, directional or nondirectional, and research or null

(statistical)?

4. If hypotheses are included in a study, are they used to organize research results and interpret study findings?

RESEARCH EXAMPLE

Hypothesis

Research Study Polman, de Castro, and van Aken (2007) conducted a study of the effects of playing versus watching violent video

games on children’s aggressive behavior. These researchers developed the following complex causal hypothesis to

direct the conduct of their study:

“It was hypothesized that playing a violent video game will lead to higher levels of aggression than watching a

violent video game or playing a non-violent game.” (Polman et al., 2007, p. 257) Continued

151CHAPTER 5 Research Problems, Purposes, and Hypotheses

Testable Hypothesis The value of a hypothesis ultimately is derived from whether it is testable in the real world. A test-

able hypothesis is one that clearly predicts the relationships among variables and contains vari-

ables that are measurable or able to be manipulated in a study. The independent variable must be

clearly defined, often by a protocol, so that it can be implemented precisely and consistently as an

intervention in a study. The dependent variable must be clearly defined to indicate how it will be

precisely and accurately measured.

A testable hypothesis also needs to predict a relationship that can be “supported” or “not sup-

ported,” as indicated by the data collected and analyzed. If the hypothesis states an associative

relationship, correlational analyses are conducted on the data to determine the existence, type,

and strength of the relationship between the variables studied. The hypothesis that states a causal

link between the independent and dependent variables is evaluated using statistics that examine

differences between the experimental and comparison or control groups, such as the t-test or

ANOVA (see Chapter 11). It is the statistical or null hypothesis (stated or implied) that is tested

to determine whether the independent variable produced a significant effect on the dependent

variable.

Hypotheses are clearer without specifying the presence or absence of a “significant difference,”

because determination of the level of significance is only a statistical technique applied to sample

data. In addition, hypotheses should not identify methodological points, such as techniques of

sampling, measurement, and data analysis (Kerlinger & Lee, 2000). Therefore, such phrases as

“measured by,” “in a random sample of,” and “using ANOVA” (analysis of variance) are

RESEARCH EXAMPLE—cont’d

Critical Appraisal Polman and colleagues (2007) conducted a quasi-experimental study to examine the effects of three independent

variables or interventions (playing violent video game, watching a violent video game, and playing a nonviolent

game) on the dependent variable level of aggression. It is important that a hypothesis was developed to direct this

type of study. The hypothesis clearly identifies the independent and dependent variables but not the population,

which included children (boys and girls) in this study. The study included three groups, and each group included

both boys and girls who were exposed to one of the interventions or independent variables. The causal relationships

examined in this study are presented in the following diagrams.

Group 1 Playing a violent video game ! Level of aggression Group 2 Watching a violent video game ! Level of aggression Group 3 Playing a nonviolent game ! Level of aggression

Implications for Practice This hypothesis was supported by the study findings for boys but not for girls. Polman and associates (2007) found

that boys who played violent video games were more aggressive than if they watched violent video games. However,

there was no relationship between game conditions and aggressive behavior in girls. The researchers recommended

additional studies with larger samples to investigate not only whether violent video games lead to aggression, but

why. They also recommended that parents and caregivers pay special attention to the regulation of violent video

game play by boys.

152 CHAPTER 5 Research Problems, Purposes, and Hypotheses

inappropriate because they limit the hypothesis to the measurement methods, sample, or analysis

techniques identified for one study. In addition, hypotheses need to reflect the variables and pop-

ulation outlined in the research purpose.

In summary, the research objectives, questions, and hypotheses must be clearly focused and

concisely expressed in studies. Both objectives and questions are used in qualitative studies and

descriptive and correlational quantitative studies, but questions are more common. Some corre-

lational studies focus on predicting relationships and may include hypotheses. Quasi-experimental

and experimental studies should be directed by hypotheses.

UNDERSTANDING STUDY VARIABLES AND RESEARCH CONCEPTS

The research purpose and objectives, questions, and hypotheses include the variables or concepts

to be examined in a study. Variables are qualities, properties, or characteristics of persons, things,

or situations that change or vary. Variables should be concisely defined to promote their measure-

ment or manipulation within quantitative or outcomes studies (Chinn & Kramer, 2011). Research

concepts are usually studied in qualitative research and are at higher levels of abstraction than vari-

ables. In this section, different types of variables are described, and conceptual and operational

definitions of variables are discussed. The research concepts investigated in qualitative research

are also discussed.

Types of Variables in Quantitative Research Variables are classified into a variety of types to explain their use in research. Some variables are

manipulated; others are controlled. Some variables are identified but not measured; others are

measured with refined measurement devices. The types of variables presented in this section

include independent, dependent, research, and extraneous variables (Fawcett & Garity, 2009;

Reynolds, 2007).

Independent and Dependent Variables The relationship between independent and dependent variables is the basis for formulating

hypotheses for correlational, quasi-experimental, and experimental studies. An independent

variable is an intervention that is manipulated or varied by the researcher to create an effect

on the dependent variable. The independent variable is also called an intervention, treatment,

or experimental variable. A dependent variable is the outcome that the researcher wants to predict

or explain. Changes in the dependent variable are presumed to be caused by the independent var-

iable. In the quasi-experimental study by Piamjariyakul and associates (2013; see earlier), the inde-

pendent variable telephone coaching program was implemented to determine its effects on the

dependent variables of caregiving burden and caregiver confidence, preparedness, and satisfaction.

In the study by Bernard and co-workers (2013), the independent variable of a counseling and exer-

cise intervention was implemented to determine its effect on tobacco consumption (dependent

variable) in patients with schizophrenia.

In predictive correlational studies, the variables measured to predict a single dependent variable

are also called independent variables (Grove et al., 2013). For example, Bindler and colleagues

(2013) conducted a predictive correlational study to predict IR (insulin resistance) in young ado-

lescents (see Table 5-1 for the problem and purpose of this study). The independent variables of

height, weight, BMI, waist circumference, systolic and diastolic blood pressures, lipid values, tri-

glycerides, and high-sensitivity C-reactive protein levels were measured and used to predict the

dependent variable of IR.

153CHAPTER 5 Research Problems, Purposes, and Hypotheses

Research Variables

Descriptive and correlational quantitative studies involve the investigation of research variables.

Research variables are the qualities, properties, or characteristics identified in the research pur-

pose and objectives or questions that are observed or measured in a study. Research variables are

used when the intent of the study is to observe or measure variables as they exist in a natural setting

without the implementation of a treatment. Thus no independent variables are manipulated and

no cause and effect relationships are examined. Buet and associates (2013) described the research

variables of HH (hand hygiene) opportunities and HH adherence for clinical caregivers (e.g.,

nurses, physicians) and nonclinical caregivers (e.g., parents, teachers) in pediatric extended-care

facilities (see Table 5-1).

Extraneous Variables Extraneous variables exist in all studies and can affect the measurement of study variables and the

relationships among these variables. Extraneous variables are of primary concern in quantitative

studies because they can interfere with obtaining a clear understanding of the relational or causal

dynamics within these studies. These variables are classified as recognized or unrecognized and

controlled or uncontrolled. Some extraneous variables are not recognized until the study is in pro-

gress or has been completed, but their presence influences the study outcome.

Researchers attempt to recognize and control as many extraneous variables as possible in quasi-

experimental and experimental studies, and specific designs, intervention protocols, and sample

criteria have been developed to control the influence of extraneous variables that might influence

the outcomes of studies. Piamjariyakul and co-workers (2013) developed a detailed protocol for

the implementation of their telephone coaching program to family caregivers of HF patients. This

protocol was based on evidence-based national clinical guidelines for the management of HF

patients and was included in the journal article. Five nurse interventionists were trained to imple-

ment this intervention consistently during the study. The sample criteria were strong in that only

primary caregivers for HF patients who assisted them daily were included in the study, and care-

givers of HF patients with Alzheimer’s disease were excluded because of their different needs. The

study would have been stronger if the sample size had been larger (n¼12) and the study design had included two groups—a comparison group in addition to the experimental group (see Chapter 8).

The extraneous variables that are not recognized until the study is in process, or are recognized

before the study is initiated but cannot be controlled, are referred to as confounding variables.

Sometimes extraneous variables can be measured during the study and controlled statistically dur-

ing analysis. However, extraneous variables that cannot be controlled or measured are a design

weakness and can hinder the interpretation of findings (see Chapter 8). As control in correlational,

quasi-experimental, and experimental studies decreases, the potential influence of confounding

variables increases.

Environmental variables are a type of extraneous variable that compose the setting in which

the study is conducted. Examples of these variables include climate, family, healthcare system, and

governmental organizations. If a researcher is studying humans in an uncontrolled or natural set-

ting, it is impossible and undesirable to control all the extraneous variables. In qualitative and

some quantitative studies (descriptive and correlational), little or no attempt is made to control

extraneous variables. The intent is to study subjects in their natural environment, without control-

ling or altering that setting or situation (Fawcett & Garity, 2009; Munhall, 2012). The environmen-

tal variables in quasi-experimental and experimental research can be controlled by using a

laboratory setting or a specially constructed research unit in a hospital. Environmental control

is an extremely important part of conducting an experimental study. For example, Sharma and

154 CHAPTER 5 Research Problems, Purposes, and Hypotheses

co-workers (2010) conducted an experimental study using mice in a laboratory setting (see

Table 5-1). The laboratory controlled for many of the environmental variables, so they did not have

an impact on the study outcomes.

Conceptual and Operational Definitions of Variables in Quantitative Research A variable is operationalized in a study by the development of conceptual and operational defini-

tions. A conceptual definition provides the theoretical meaning of a variable (Chinn & Kramer,

2011) and is often derived from a theorist’s definition of a related concept. In a published study, the

framework includes concepts and their definitions, and the variables are selected to represent these

concepts. The variables are conceptually defined, indicating the link with the concepts in the

framework. An operational definition is derived from a set of procedures or progressive acts that

a researcher performs to receive sensory impressions (e.g., sound, visual, or tactile impressions)

that indicate the existence or degree of existence of a variable (Reynolds, 2007). Operational def-

initions need to be independent of time and setting so that variables can be investigated at different

times and in different settings using the same operational definitions. An operational definition is

developed so that a variable can be measured or manipulated in a concrete situation; the knowl-

edge gained from studying the variable will increase the understanding of the theoretical concept

that this variable represents.

Two variables are operationalized as an example from Piamjariyakul and colleagues’ (2013)

study of the effect of a telephone coaching program on HF home management for family care-

givers. The conceptual and operational definitions for the independent variable telephone coach-

ing program and one of the dependent variables, caregiving burden, are presented in the following

research example. The guidelines identified in the following box were used to critically appraise the

variables and their definitions in this study.

? CRITICAL APPRAISAL GUIDELINES Study Variables

1. Are the variables clearly identified in the study purpose and/or research objectives, questions, or hypotheses?

2. What types of variables are examined in the study? Are independent and dependent variables or research

variables examined in the study?

3. If a quasi-experimental or experimental study is conducted, are the extraneous variables identified and

controlled?

4. Are the variables conceptually defined?

5. Are the variables operationally defined?

RESEARCH EXAMPLE

Conceptual and Operational Definitions of Variables

Independent Variable: Telephone Coaching Program Conceptual Definition The telephone coaching program was developed based on the study framework of coaching by healthcare profes-

sionals. The program included evidence-based coaching strategies designed to improve intermediate and long-term

caregivers’ outcomes (Piamjariyakul et al., 2013). Continued

155CHAPTER 5 Research Problems, Purposes, and Hypotheses

Research Concepts Investigated in Qualitative Research The variables in quasi-experimental and experimental research are narrow and specific in focus

and can be quantified (converted to numbers) or manipulated using specified steps that are often

developed into a protocol. In addition, the variables are objectively defined to decrease researcher

bias, as indicated in the previous section. Qualitative research is more abstract, subjective, and

holistic than quantitative research and involves the investigation of research concepts versus

research variables. Research concepts include the ideas, experiences, situations, or events that

are investigated in qualitative research. For example, Trollvik and associates (2011, p. 295)

conducted a qualitative study to explore the phenomenon of “children’s experiences of living with

asthma.” The problem and purpose for this phenomenological study are presented in Table 5-2.

The research concept explored was “experiences of living with asthma” as perceived by children. In

many qualitative studies, the focus of the study is to define or describe the concept(s) being studied

(Munhall, 2012). In this study, the research concept of living with asthma was defined as including

two themes—fear of exacerbations and fear of being ostracized. The fear of exacerbations included

the subthemes of bodily sensations, frightening experiences, and loss of control. The fear of being

ostracized included the subthemes of experiences of being excluded and the dilemma of keeping

the asthma secret or being open about it. More details on the research concepts studied in qual-

itative research are found in Chapter 3.

RESEARCH EXAMPLE—cont’d

Operational Definition The telephone coaching program was an intervention implemented by five nurse interventionists to family care-

givers using a detailed protocol, which included specific educational objectives and selected coaching activities based

on the evidence-based national clinical guidelines for management of HF patients (see protocol in Piamjariyakul

et al., 2013, p. 35; this article can be accessed from the Elsevier website for this text).

Dependent Variable: Caregiving Burden Conceptual Definition Caregiving burden is a long-term outcome thought to be improved by the implementation of evidence-based

coaching strategies by health professionals (Piamjariyakul et al., 2013).

Operational Definition “Caregiving burden of HF homecare management was measured using a 17-item five-point Likert-type scale,

with higher scores indicating more burden or difficulty in providing HF home caregiving.” Piamjariyakul et al.,

2013, p. 34

This scale was modified based on the original Oberst Caregiving Burden Scale.

Critical Appraisal The variables in this study were clearly identified and defined. The independent and dependent variables were iden-

tified in the research questions (see earlier). The conceptual definitions for the telephone coaching program and

caregiving burden were based on the study framework (see the model and description in Piamjariyakul et al.,

2013, p. 33). The operational definitions for the variables were found in the methods section of the research report.

These definitions were strong and provided clear direction for the implementation of the intervention and mea-

surement of the dependent variable in the study.

Implications for Practice Findings from this study were discussed earlier in this chapter when the problem and purpose of this study were

presented as examples.

156 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Demographic Variables Demographic variables are attributes of subjects that are collected to describe the sample. The

demographic variables are identified by the researcher when a proposal is developed for conduct-

ing a study. Some common demographic variables are age, education, gender, ethnic origin (race),

marital status, income, job classification, and medical diagnosis. Once data are collected from the

study subjects on these demographic variables and analyzed, the results are called sample charac-

teristics used to describe the sample. A study’s sample characteristics can be presented in table

format and/or narrative. Piamjariyakul and co-workers (2013), in a study discussed earlier, pre-

sented most of their sample characteristics in a table and discussed others in the narrative of their

article. Table 5-4 identifies the sample characteristics for the family caregivers and patients with HF.

The demographic variables described for the family caregivers and patients with HF included age,

gender, employment, education, and race. These are common demographic variables examined to

describe study samples and are the basis for comparison with samples from other studies. Two

other demographic variables were described in Table 5-4, caregivers’ relationship to the patient

with HF and the patient’s EF (ejection fraction). In the narrative of the article, 10 of the 12 “care-

givers reported having one or more chronic health problems (osteoarthritis, hypertension, asthma,

myocardial infarction, and diabetes mellitus). . . . One caregiver did not have health insurance

TABLE 5-4 SAMPLE CHARACTERISTICS OF HF PATIENTS AND THEIR CAREGIVERS ENROLLED IN THIS PILOT STUDY (n=12)

CAREGIVER

CHARACTERISTICS

PERCENTAGE/MEAN

(SD) N (%)

PATIENT

CHARACTERISTICS

PERCENTAGE/MEAN

(SD) N (%)

Caregiver Age (years) 62.6 (13.7); range¼38-81 Patient Age (years) 61.6 (12.8); range¼43-79 Caregiver Gender Patient Gender

Female 9 (75) Female 4 (33.3)

Male 3 (25) Male 8 (66.7)

Employment Employment

Full or part time 3 (25) Full or part time 1 (8.3)

Retired 7 (58.3) Retired 6 (50)

Retired/disabled 2 (16.7) Retired/disabled 4 (33.3)

Missing (did not

answer)

1 (8.3)

Education Education

High school 1 (8.3) High school or lower 5 (41.7)

Technical/some college 7 (58.3) Technical/some

college

6 (50)

College or more 4 (33.3) College or more 1 (8.3)

Race Race

White 8 (66.7) Caucasian 6 (50)

African American 4 (33.3) African American 5 (41.7)

Relationship Other 1 (8.3)

Spouse 8 (66.7)

Adult child 1 (8.3) EF

Mother 1 (8.3) �40% 9 (75) Other 2 (16.7) >40% 3 (25)

EF, Ejection fraction; HF, heart failure; n, sample size; N, frequency; SD, standard deviation.

From Piamjariyakul, U., Smith, C. E., Russell, C., Werkowitch, M., & Elyachar, A. (2013). The feasibility of a telephone

coaching program on heart failure home management for family caregivers. Heart & Lung, 42(1), 37.

157CHAPTER 5 Research Problems, Purposes, and Hypotheses

coverage” (Piamjariyakul et al., 2013, p. 36). The demographic variables of chronic illnesses and

insurance coverage were also described for the caregivers. The researchers provided a quality

description of their sample characteristics in their study.

K E Y C O N C E P T S

• The research problem is an area of concern in which there is a gap in the knowledge base needed

for nursing practice. The problem includes significance, background, and problem statement.

• The research purpose is a concise, clear statement of the specific goal or focus of the study.

• A significant problem and purpose influence nursing practice, build on previous research, pro-

mote theory development, and/or address current concerns or priorities in nursing.

• Study feasibility is evaluated by examining the researchers’ expertise, money commitments,

availability of subjects, facilities, and equipment, and the study’s ethical considerations.

• Research objectives, questions, or hypotheses are formulated to bridge the gap between the

more abstractly stated research problem and purpose and the detailed quantitative design

and data analysis.

• A qualitative study often includes problem, purpose, and research questions or aims to direct

the study.

• A hypothesis is the formal statement of the expected relationship(s) between two or more vari-

ables in a specified population in a quantitative or outcomes study.

• Hypotheses can be described using four categories: (1) associative versus causal; (2) simple ver-

sus complex; (3) nondirectional versus directional; and (4) statistical versus research.

• Variables are qualities, properties, or characteristics of persons, things, or situations that change

or vary.

• An independent variable is an intervention or treatment that is manipulated or varied by the

researcher to create an effect on the dependent variable.

• A dependent variable is the outcome that the researcher wants to predict or explain.

• In predictive correlational studies, independent variables are measured to predict a dependent

variable.

• Research variables are the qualities, properties, or characteristics that are observed or measured

in descriptive and correlational studies.

• A variable is operationalized in a study by developing conceptual and operational definitions.

• A conceptual definition provides the theoretical meaning of a variable and is derived from a

theorist’s definition of a related concept.

• Operational definitions indicate how a treatment or independent variable will be implemented

and how the dependent or outcome variable will be measured.

• Research concepts include the ideas, experiences, situations, or events that are investigated in

qualitative research.

• Research concepts are defined and described during the conduct of qualitative studies.

• Demographic variables are collected and analyzed to determine sample characteristics for

describing the study subjects or participants.

REFERENCES

Agency for Healthcare Research and Quality (AHRQ),

(2013). AHRQ research funding priorities. Retrieved

July 2, 2013 from, http://www.ahrq.gov/legacy/fund/

ragendix.htm.

American Association of Critical-Care Nurses (AACN),

(2013). AACN’s research priority areas. Retrieved July 2,

2013 from, http://www.aacn.org, and search for

Research Priorities.

158 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Ausserhofer, D., Schubert, M., Desmedt, M., Belgen, M. A.,

De Geest, S., & Schwendimann, R. (2013). The

association of patient safety climate and nurse-related

organizational factors with selected patient outcomes:

A cross-sectional survey. International Journal of

Nursing Studies, 50(2), 240–252.

Bernard, P. P. N., Esseul, E. C., Raymond, L.,

Dandonneau, L., Xambo, J., Carayol, M. S., et al.

(2013). Counseling and exercise intervention for

smoking reduction in patients with schizophrenia:

Feasibility study. Archives of Psychiatric Nursing, 27(1),

23–31.

Bindler, R. J., Bindler, R. C., & Daratha, K. B. (2013).

Biological correlates and predictors of insulin

resistance among early adolescents. Journal of Pediatric

Nursing, 28(1), 20–27.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Buet, A., Cohen, B., Marine, M., Scully, F., Alper, P.,

Simpser, E., et al. (2013). Hand hygiene opportunities

in pediatric extended care facilities. Journal of Pediatric

Nursing, 28(1), 72–76.

Burns, K. H., Casey, P. H., Lyle, R. E., Bird, T. M.,

Fussell, J. J. , & Robbins, J. M. (2010). Increasing

prevalence of medically complex children in U.S.

hospitals. Pediatrics, 126(4), 638–646.

Centers for Disease Control and Prevention (CDC),

(2006). A comprehensive immunization strategy to

eliminate transmission of hepatitis B virus infection in

the United States. Morbidity and Mortality Weekly

Report, 55(RR-16), 1–25.

Centers for Disease Control and Prevention (CDC),

(2008). Surveillance for acute viral hepatitis—United

States, 2006. Morbidity and Mortality Weekly Report, 57

(SS02), 1–24.

Child Welfare League of America, (2007). Quick facts about

foster care. Retrieved March 14, 2013 from, http://cwla.

org/programs/fostercare/factsheet.htm.

Chinn, P. L., & Kramer, M. K. (2011). Integrated theory and

knowledge development in nursing (8th ed.). St. Louis:

Elsevier Mosby.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh: Churchill

Livingstone Elsevier.

Creswell, J. W. (2014). Research design: Qualitative,

quantitative, and mixed methods approaches (4th ed.).

Thousand Oaks, CA: Sage.

Doran, D. M. (2011). Nursing outcomes: The state of the

science (2nd ed.). Canada: Jones & Bartlett Learning.

Dunbar, S. B., Clark, P. C., Deaton, C., Smith, A. L., De, A.

K., & O’Brien, M. C. (2005). Family education and

support interventions in heart failure: A pilot study.

Nursing Research, 54(2), 158–166.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia: F. A.

Davis.

Gartner, L. M., Morton, J., Lawrence, R. A., Naylor, A. J.,

O’Hare, D., Schanler, R. J., et al. American Academy of

Pediatrics Section on Breastfeeding. (2005).

Breastfeeding and the use of human milk. Pediatrics,

115(2), 496–506.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis: Elsevier Saunders.

Hale, E. D., Treharne, G. J., & Kitas, G. D. (2007).

Qualitative methodologies I: Asking research questions

with reflexive insight. Musculoskeletal Care, 5(3),

139–147.

Happ, M. B., Swigart, V. A., Tate, J. A., Arnold, R. M.,

Sereika, S. M., & Hoffman, L. A. (2007). Family

presence and surveillance during weaning from

prolonged mechanical ventilation. Heart & Lung, 36

(1), 47–57.

Hudson, A. L. (2012). Where do youth in foster care

receive information about preventing unplanned

pregnancy and sexually transmitted infections? Journal

of Pediatric Nursing, 27(5), 443–450.

Institute of Medicine, (2004). Patient safety: Achieving a

new standard for care. Washington, DC: National

Academies Press.

Kerlinger, F. N., & Lee, H. B. (2000). Foundations of

behavioral research (4th ed.). Fort Worth, TX: Harcourt

College.

Letourneau, N., Young, C., Secco, L., Stewart, M.,

Hughes, J., & Critchley, K. (2011). Supporting

mothering: Service providers’ perspectives of mothers

and young children affected by intimate partner

violence. Research in Nursing & Health, 34(3), 192–203.

Li, C., Ford, E. S., Huang, T. T., Sun, S. S., & Goodman, E.

(2009). Patterns of change in cardiometabolic risk

factors associated with the metabolic syndrome among

children and adolescents: The Fels Longitudinal Study.

Journal of Pediatrics, 155(S5), e9–e16.

Lindeman, C. A. (1975). Delphi survey of priorities in

clinical nursing research. Nursing Research, 24(6),

434–441.

Litrownik, A. J., Newton, R., Hunter, W. M., English, D., &

Everson, M. D. (2003). Exposure to family violence in

young at-risk children: A longitudinal look at the effects of

victimization and witnessed physical and psychological

aggression. Journal of Family Violence, 18(1), 59–73.

Lundy, K. S. (2012). Historical research. In P. L. Munhall

(Ed.), Nursing research: A qualitative perspective

159CHAPTER 5 Research Problems, Purposes, and Hypotheses

(pp. 381–397) (5th ed.). Sudbury, MA: Jones & Bartlett

Learning.

Marshall, C., & Rossman, G. B. (2011). Designing

qualitative research (5th ed.). Los Angeles: Sage.

Masoli, M., Fabian, D., Holt, S., & Beasley, R. Global

Initiative for Asthma (GINA) Program. (2004). The

global burden of asthma: Executive summary of the

GINA Dissemination Committee Report. Allergy, 59

(5), 469–478.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-

based practice in nursing & healthcare: A guide to best

practice (2nd ed.). Philadelphia: Lippincott, Williams &

Wilkins.

Munhall, P. L. (2012). Nursing research: A qualitative

perspective (5th ed.). Sudbury, MA: Jones & Bartlett

Learning.

National Institute of Nursing Research (NINR), (2011).

Mission and strategic plan. Retrieved March 16, 2013

from, http://www.ninr.nih.gov/aboutninr/ninr-

mission-and-strategic-plan.

Nyamathi, A., Liu, Y., Marfisee, M., Shoptaw, S.,

Gregerson, P., Saab, S., et al. (2009). Effects of a nurse-

managed program on hepatitis A and B vaccine

completion among homeless adults. Nursing Research,

58(1), 13–22.

Piamjariyakul, U., Smith, C. E., Russell, C.,

Werkowitch, M., & Elyachar, A. (2013). The feasibility

of a telephone coaching program on heart failure home

management for family caregivers. Heart & Lung, 42

(1), 32–39.

Polman, H., de Castro, B. O., & van Aken, M. A. (2007).

Experimental study of the differential effects of playing

versus watching violent video games on children’s

aggressive behavior. Aggressive Behavior, 34, 256–264.

Retrieved March 12, 2009 from, www.interscience.

wiley.com.

Price, D., Ryan, D., Pearce, L., Bawden, R., Freeman, D.,

Thomas, M., et al. (2002). The burden of pediatric

asthma is higher than health professionals think:

Results from the Asthma In Real Life (AIR) study.

Primary Care Respiratory Journal, 11(1), 30–33.

Quality and Safety Education for Nurses (QSEN), (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved July 2, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas.

Reutter, L., & Kushner, K. E. (2010). Healthy equity

through action on the social determinants of health:

Taking up the challenge in nursing. Nursing Inquiry, 17

(3), 269–280.

Reynolds, P. D. (2007). A primer in theory construction.

Boston: Allyn & Bacon Classics.

Riegel, B., Moser, D. K., Anker, S. D., Appel, L. J.,

Dunbar, S. B., Grady, K. L., et al. (2009). State

of the science: Promoting self-care in persons with

heart failure: A scientific statement from the

American Heart Association. Circulation, 120(12),

1141–1163.

Rogers, B. (1987). Research corner: Is the research project

feasible? American Association of Occupational Health

Nurses Journal, 35(7), 327–328.

Rohrbeck, J., Jordan, K., & Croft, P. (2007). The frequency

and characteristics of chronic widespread pain in

general practice: A case-control study. British Journal of

General Practice, 57(535), 109–115.

Schultz, A. A., Drew, D., & Hewitt, H. (2002). Comparison

of normal saline and heparinized saline for patency of

IV locks in neonates. Applied Nursing Research, 15(1),

28–34.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002).

Experimental and quasi-experimental designs for

generalized causal inference. Chicago: Rand McNally.

Sharma, N. K., Ryals, J. M., Gajewski, B. J., & Wright, D. E.

(2010). Aerobic exercise alters analgesia and

neurotrophin-3 synthesis in an animal model of

chronic widespread pain. Physical Therapy, 90(5),

714–725.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Tenfelde, S. M., Finnegan, L., Miller, A. M., & Hill, P. D.

(2012). Risk of breastfeeding cessation among low-

income women, infants, and children. Nursing

Research, 61(2), 86–95.

Thompson, M. E., & Keeling, A. A. (2012). Nurses’ role in

the prevention of infant mortality in 1884–1925:

Health disparities then and now. Journal of Pediatric

Nursing, 27(5), 471–478.

Trollvik, A., Nordbach, R., Silen, C., & Ringsberg, K. C.

(2011). Children’s experiences of living with asthma:

Fear of exacerbations and being ostracized. Journal of

Pediatric Nursing, 26(4), 295–303.

U.S. Department of Health and Human Services (U.S.

DHHS). (2010). Healthy People 2020. Retrieved July 2,

2013 from, http://www.healthypeople.gov/hp2020.

U.S. Department of Health and Human Services (U.S.

DHHS). (2013). Healthy People 2020: Topics and

objectives. Retrieved July 2, 2013 from, http://

healthypeople.gov/2020/topicsobjectives2020.

Wasley, A., Miller, J. T., & Finelli, L. (2007). Surveillance for

acute viral hepatitis—United States, 2005. Morbidity

and Mortality Weekly Report. CDC Surveillance

Summaries, 56(3), 1–24.

160 CHAPTER 5 Research Problems, Purposes, and Hypotheses

Whiteside, A., Hansen, S., & Chaudhuri, A. (2004).

Exercise lowers pain threshold in chronic fatigue

syndrome. Pain, 109(3), 497–499.

Wolf, Z. R. (2012). Ethnography: The method. In P. L.

Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 285–338) (5th ed.). Sudbury, MA:

Jones & Bartlett Learning.

World Health Organization (WHO). (2009). Guidelines for

hand hygiene in health care. Retrieved July 2, 2013 from,

http://who.int/gpsc/5may/tools/9789241597906/en.

World Health Organization (WHO). (2011). Obesity and

overweight. Retrieved July 2, 2013 from, http://www.

who.int/mediacentre/factsheets/fs311/en.

World Health Organization (WHO). (2013). Programmes

and projects. Retrieved March 17, 2013 from, http://

www.who.int/entity/en.

Wuest, J. (2012). Grounded theory: The method. In

P. L. Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 225–256) (5th ed.). Sudbury, MA:

Jones & Bartlett Learning.

161CHAPTER 5 Research Problems, Purposes, and Hypotheses

C H A P T E R

6 Understanding and Critically Appraising the Literature Review

C H A P T E R OV E R V I E W

Purpose of the Literature Review, 163

Purpose of the Literature Review in Quantitative

Research, 163

Purpose of the Literature Review in Qualitative

Research, 164

Sources Included in a Literature Review, 165

Types of Publications, 166

Content of Publications, 166

Quality of Sources, 167

Critically Appraising Literature Reviews, 168

Critical Appraisal of a Literature Review in a

Quantitative Study, 168

Critical Appraisal of a Literature Review in a

Qualitative Study, 172

Reviewing the Literature, 176

Preparing to Review the Literature, 176

Conducting the Literature Review, 178

Processing the Literature, 180

Writing the Review of the Literature, 183

Key Concepts, 186

References, 186

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Discuss the purposes of the literature review in

quantitative and qualitative research.

2. Identify the sources included in a literature

review.

3. Differentiate a primary source from a secondary

source.

4. Critically appraise the literature review section of

a published study.

5. Conduct a computerized search of the

literature.

6. Read and critically appraise literature to develop

a synthesis of the literature.

7. Write a literature review to promote the use

of evidence-based knowledge in nursing

practice.

K E Y T E R M S

Article, p. 166

Bibliographic database, p. 177

Citation, p. 165

Clinical journals, p. 166

Comprehending a source, p. 180

Conclusion, p. 184

Conference proceedings, p. 166

Current sources, p. 167

Data-based literature, p. 167

Digital object identifiers

(DOI), p. 184

Dissertation, p. 166

Empirical literature, p. 167

Encyclopedia, p. 166

Keywords, p. 178

Landmark studies, p. 167

Literature, p. 165

Monograph, p. 166

162

Paraphrasing, p. 184

Peer-reviewed, p. 167

Periodical, p. 166

Primary source, p. 167

Reference, p. 165

Relevant studies, p. 167

Replication studies, p. 167

Review of literature, p. 163

Secondary source, p. 167

Seminal studies, p. 167

Synthesis, p. 183

Textbooks, p. 166

Theoretical literature, p. 166

Thesis, p. 166

Websites, p. 166

A high-quality review of literature contains the current theoretical and scientific knowledge about

a specific topic. The review identifies what is known and unknown about the topic. Nurses in clin-

ical practice review the literature to synthesize the available evidence to find a solution to a prob-

lem in practice or because they want to remain current in their practice. As they read studies, they

must critically appraise the literature review, as well as the other components of the study. Critically

appraising a review of the literature begins with understanding the purpose of the literature

review in quantitative and qualitative studies and the relative quality of the different types of ref-

erences that are cited. The critical appraisal guidelines for literature reviews listed in this

chapter can be applied to both quantitative and qualitative studies. In addition, examples are pro-

vided of critical appraisals of the literature reviews in a quantitative study and another in a

qualitative study.

You may be required to review the literature as part of a course assignment or project in the

clinical setting, especially projects in Magnet hospitals. Nurses in Magnet hospitals must imple-

ment evidence-based practice, identify problems, and assist with data collection for research stud-

ies (American Nurses Credentialing Center [ANCC], 2013). Reviewing the literature is a first step

in implementing evidence-based practice and identifying problems. (Chapter 13 identifies the

research responsibilities of nurses in Magnet facilities.)

A review of literature is the process of finding relevant research reports, critically appraising the

studies, and synthesizing the study results. The written description of the literature that results

from the process is also called a review of the literature. As a foundation for this process, this chap-

ter includes information on how to find references, select those that are relevant, organize what you

find, and write a logical summary of the findings.

PURPOSE OF THE LITERATURE REVIEW

Literature reviews in published research reports provide the background for the problem studied.

Such reviews include (1) describing the current knowledge of a practice problem, (2) identifying

the gaps in this knowledge base, and (3) explaining how the study being reported contributed to

building knowledge in this area. The scope of a literature review must be broad enough to allow the

reader to become familiar with the research problem and narrow enough to include only the most

relevant sources.

Purpose of the Literature Review in Quantitative Research The review of literature in quantitative research is conducted to direct the planning and execution

of a study. The major literature review is performed at the beginning of the research process (before

the study is conducted). A limited review is conducted after the study is completed to identify

studies published since the original literature review, especially if it has been 1 year or longer since

163CHAPTER 6 Literature Review

the study began. Additional articles may be retrieved to find information relevant to interpreting

the findings. The results of both reviews are included in the research report. The purpose of the

literature review is similar for the different types of quantitative studies—descriptive, correlational,

quasi-experimental, and experimental.

Quantitative research reports may include citations to relevant sources in all sections of the

report. The researchers include sources in the introduction section to summarize the background

and significance of the research problem. Citations about the number of patients affected, cost

of treatment, and consequences in terms of human suffering and physical health may be included.

The review of literature section may not be labeled but be integrated into the introduction. The

review includes theoretical and research references that document current knowledge about

the problem studied.

A quantitative study develops its framework section (not always so labeled) from the theoretical

literature and sometimes from research reports, depending on the focus of the study. The methods

section of the research report describes the design, sample and the process for obtaining the sam-

ple, measurement methods, treatment, and data collection process. References may be cited in var-

ious parts of the methods section as support for the appropriateness of the methods used in the

study. The results section includes the results of the statistical analyses, but also includes sources to

validate the analytical techniques that were used to answer the research questions. Sources might

also be included to compare the analysis of the data in the present study with the results of previous

studies. The discussion section of the research report provides the comparison of the findings to

other studies’ findings, if not already included in the results section. The discussion section also

incorporates conclusions that are a synthesis of the findings from previous research and those from

the present study.

Purpose of the Literature Review in Qualitative Research In qualitative research reports, the introduction will be similar to the same section in the quan-

titative study report because the researchers document the background and significance of the

research problem. Researchers often include citations to support the need to study the selected

topic (Creswell, 2013). However, additional review of the literature may not be cited for two rea-

sons. One reason is that qualitative studies are often conducted on topics about which we know

very little, so little literature is available to review. The other reason is that some qualitative

researchers deliberately do not review the literature deeply prior to conducting the study because

they do not want their expectations about the topic to bias their data collection, data analysis, and

findings (Munhall, 2012). This is consistent with the expectation that qualitative researchers

remain open to the perspectives of the participants. In the methods, results, and discussion sec-

tions, qualitative researchers will incorporate literature to support the use of specific methods and

place the findings in the context of what is already known.

The purpose, extent, and timing of the literature review vary across the different qualitative

approaches (Grove, Burns, & Gray, 2013). Phenomenologists are among those who are likely to

delay literature review until after data collection and initial analysis have been completed

(Munhall, 2012). These researchers will review the literature in the later stages of the analysis

and as they interpret the findings in the larger context of theoretical and empirical knowledge.

Grounded theory researchers include a minimal review of relevant studies at the beginning of

the research process. This review is merely a means of making the researcher aware of what studies

have been conducted and that a research problem exists (Corbin & Strauss, 2008), but the infor-

mation from these studies is not used to direct data collection or theory development for the

164 CHAPTER 6 Literature Review

current study (Walls, Pahoo, & Fleming, 2010). The researcher uses the literature primarily to

explain, support, and extend the theory generated in the study (Wuerst, 2012).

The review of literature in ethnographic research is similar to that in quantitative research. In

early ethnographies of unexplored groups of people in distant locations, culture-specific literature

was not available to review prior to data collection. Theoretical and philosophical literature, how-

ever, was and continues to be used to provide a framework or perspective through which

researchers approach data collection. The research problem for an ethnography is based on a

review of the literature that identifies how little is known about the culture of interest (Wolf,

2012). The review also informs the research process by providing a general understanding of

the cultural characteristics to be examined. For example, the literature review for an ethnography

of nursing in Uganda would reveal that the healthcare system has referral hospitals, district hos-

pitals, and health centers. With this information, the researcher might decide to develop a data

collection plan to observe nurses in each setting, or the researcher might decide to narrow the eth-

nography to health centers. Another example would be the ethnographer studying health behav-

iors of Burmese refugees in a specific neighborhood. From the literature, the researcher learned

that older community members are highly respected and, as a result, the researcher would seek

support of older refugees to facilitate access to others in the community. Ethnographers return

to the literature during analysis and interpretation of the data to expand the readers’ understand-

ing of the culture.

Researchers using the exploratory-descriptive qualitative and historical approaches may be con-

ducting the study because they have reviewed the literature and found that little knowledge is avail-

able. Exploratory-descriptive qualitative researchers want to understand a situation or practice

problem better so solutions can be identified (Grove et al., 2013). Historical researchers conduct

an initial review of current literature and identify an event or time in history about which little is

known and that has possible implications for nursing and health care today. Publications contem-

porary to the event or time are the sources of data. The researchers develop an inventory of sources,

locate these sources, and examine them (Lundy, 2012). Because historical research requires an

extensive review of literature that is sometimes difficult to locate, the researcher can spend months

and even years locating and examining sources. Chapter 3 contains additional information about

literature reviews in qualitative studies.

SOURCES INCLUDED IN A LITERATURE REVIEW

The literature is all written sources relevant to the topic you have selected, including articles pub-

lished in periodicals or journals, Internet publications, monographs, encyclopedias, conference

papers, theses, dissertations, clinical journals, textbooks, and other books. Websites and reports

developed by government agencies and professional organizations are also included. Each source

reviewed by the author and used to write the review is cited. A citation is the act of quoting a

source, paraphrasing content from a source, using it as an example, or presenting it as support

for a position taken. Each citation should have a corresponding reference in the reference list.

The reference is documentation of the origin of the cited quote or paraphrased idea and provides

enough information for the reader to locate the original material. This information is typically the

original author’s name, year, and title of publication and, when necessary, periodical or mono-

graph title, volume, pages, and other location information as required by standard style writing

manuals. The style developed by the American Psychological Association (APA, 2010) is

165CHAPTER 6 Literature Review

commonly used in nursing education programs and journals. More information about APA style is

provided later in this chapter.

Types of Publications An article is a paper about a specific topic and may be published together with other articles on

similar themes in journals (periodicals), encyclopedias, or edited books. As part of an edited book,

articles may be called chapters. A periodical such as a journal is published over time and is num-

bered sequentially for the years published. This sequential numbering is seen in the year, volume,

issue, and page numbering of a journal. A monograph, such as a book on a specific subject, a

record of conference proceedings, or a pamphlet, usually is a one-time publication. Periodicals

and monographs are available in a variety of media, including online and in print. An encyclope-

dia is an authoritative compilation of information on alphabetized topics that may provide back-

ground information and lead to other sources, but is rarely cited in academic papers and

publications. Some online encyclopedias are electronic publications that have undergone the same

level of review as published encyclopedias. Other online encyclopedias, such as Wikipedia, are in an

open, editable format and, as a result, the credibility of the information is variable. Using Wiki-

pedia as a professional source is controversial (Luyt, Ally, Low, & Ismail, 2010; Younger, 2010).

When you are writing a review of the literature, Wikipedia may provide ideas for other sources

that you may want to find but check with your faculty about whether Wikipedia or any other ency-

clopedia may be cited for course assignments.

Major professional organizations may publish papers selected by a review process that were pre-

sented at their conference, called conference proceedings. These publications may be in print or

online. Conference proceedings may include the findings of pilot studies and preliminary findings

of ongoing studies. A thesis is a report of a research project completed by a postgraduate student as

part of the requirements for a master’s degree. A dissertation is a report of an extensive, sometimes

original, research project that is completed as the final requirement for a doctoral degree. Theses

and dissertations can be cited in a literature review. In some cases, an article may be published

based on the student’s thesis or dissertation. Clinical journals are periodicals that include research

reports and non-research articles about practice problems and professional issues. You are familiar

with textbooks as a source of information for academic courses. Other books on theories,

methods, and events may also be cited in a literature review. To evaluate the quality of a book,

consider the qualifications of the author related to the topic, and review the evidence that the

author provides to support the book’s premises and conclusions. With textbooks and other books,

chapters in an edited book might have been written by different people, which are cited differently

than the book as a whole. This is important to note when checking citations and writing your own

literature reviews.

Electronic access to articles and books has increased dramatically, making many types of pub-

lished literature more widely available. In addition, websites are an easily accessible source of

information. Not all websites are valid and appropriate, however, for citation in a literature review.

The website of a company that sells diuretic medications may not be an appropriate source for

hypertension statistics. In contrast, websites prepared and sponsored by government agencies

and professional organizations are considered appropriate references to cite.

Content of Publications References cited in literature reviews contain two main types of content, (1) theoretical and (2)

empirical. Theoretical literature includes concept analyses, models, theories, and conceptual

frameworks that support a selected research problem and purpose. Theoretical sources can be

166 CHAPTER 6 Literature Review

found in books, periodicals, and monographs. Nursing theorists have written books to describe the

development and content of their theories. Other books contain summaries of several theories. In a

published study, theoretical and conceptual sources are described and summarized to reflect the

current understanding of the research problem and provide a basis for the study framework.

Empirical literature in this context refers to knowledge derived from research. In other words,

the knowledge is based on data from research (data-based). Data-based literature consists of

reports of research and includes published studies, usually in journals, on the Internet, or books,

and unpublished studies, such as master theses and doctoral dissertations.

Quality of Sources Most references cited in quality literature reviews are primary sources that are peer-reviewed. A

primary source is written by the person who originated or is responsible for generating the ideas

published. A research report written by the researchers who conducted the study is a primary

source. A theorist’s development of a theory or other conceptual content is a primary source. A

secondary source summarizes or quotes content from primary sources. Authors of secondary

sources paraphrase the works of researchers and theorists and present their interpretation of what

was written by the primary author. As a result, information in secondary sources may be misin-

terpretations of the primary authors’ thoughts. Secondary sources are used only if primary sources

cannot be located, or the secondary source provides creative ideas or a unique organization of

information not found in a primary source. Peer-reviewed means that the author of the research

report, clinical description, or theoretical explanation has submitted a manuscript to a journal

editor, who identified scholars familiar with the topic to review the manuscript. These scholars

provide input to the editor about whether the manuscript in its current form is accurate, meets

standards for quality, and is appropriate for the journal. A peer-reviewed paper has undergone

significant scrutiny and is considered trustworthy.

Quality literature reviews include relevant and current sources. Relevant studies are those with a

direct bearing on the problem of concern. Current sources arethose published within 5 yearsbefore

publication of the manuscript. Sources cited should be comprehensive as well as current. Some

problems have been studied for decades, and the literature review often includes seminal and land-

mark studies that were conducted years ago. Seminal studies are the first studies on a particular

topic that signaled the beginning of a new way of thinking on the topic and sometimes are referred

to as classical studies. Landmark studies are significant research projects that have generated

knowledge that influences a discipline and sometimes society as a whole. Such studies frequently

are replicated or serve as the basis for the generation of additional studies. Some authors may

describe a landmark study as being a groundbreaking study. Citing a few older studies significant

to the development of knowledge on the topic being reviewed is appropriate. Most publications

cited, however, should be current. Replication studies are reproductions or repetitions of a study

that researchers conduct to determine whether the findings of the original study could be found

consistently in different settings and with different subjects. Replication studies are important to

build the evidence for practice. A replication study that supports the findings of the original study

increases the credibility of the findings and strengthens the evidence for practice. A replication that

does not support the original study findings raises questions about the credibility of the findings.

Syntheses of research studies, another type of data-based literature, may be cited in literature

reviews. A research synthesis may be a systematic review of the literature, meta-analysis of quan-

titative studies, meta-synthesis of qualitative studies, or a mixed-method systematic review. These

publications are valued for their rigor and contributions to evidence-based practice (see Chapters 1

and 13).

167CHAPTER 6 Literature Review

CRITICALLY APPRAISING LITERATURE REVIEWS

Appraising the literature review of a published study involves examining the quality of the content

and sources presented. A correctly prepared literature review includes what is known and not

known about the study problem and identifies the focus of the present study. As a result, the review

provides a basis for the study purpose and may be organized according to the variables (quanti-

tative) or concepts (qualitative) in the purpose statement. The sources cited must be relevant and

current for the problem and purpose of the study. The reviewer must locate and review the sources

or respective abstracts to determine whether these sources are relevant. To judge whether all the

relevant sources are cited, the reviewer must search the literature to determine the relevant sources.

This is very time-consuming and usually is not done for appraisal of an article. However, you can

review the reference list and determine the focus of the sources, the number of data-based and

theoretical sources cited, and where and when the sources were published. Sources should be cur-

rent, up to the date the paper was accepted for publication. Most articles indicate when they were

accepted for publication on the first page of the study.

Although the purpose of the literature review for a quantitative study is different from the pur-

pose of the literature review for a qualitative study, the guidelines for critically appraising the

literature review of quantitative and qualitative studies are the same. However, because the pur-

poses of literature reviews are different, the type of sources and the extent of the literature cited

may vary.

Critical Appraisal of a Literature Review in a Quantitative Study The anxiety related to having a surgical or diagnostic procedure can have adverse effects. Brand,

Munroe, and Gavin (2013, p. 708) conducted a quasi-experimental study to “determine the effects

of hand massage on patient anxiety in the ambulatory surgical setting.” The section entitled

“Literature Review” (pp. 709-710) is included as an example and is critically appraised. In addition

? CRITICAL APPRAISAL GUIDELINES Literature Reviews

1. Inclusion of relevant literature

• Did the researchers describe previous studies and relevant theories? • What other types of literature were cited?

2. Currency of sources

• Are the references current (number and percentage of sources in the last 10 years and in the last 5 years)? • Are landmark, seminal, and/or replication studies included?

3. Breadth of the review

• Identify the disciplines of the authors of studies cited in this paper and the journals in which they published their studies.

• Does it appear that the author searched databases outside of the Cumulative Index of Nursing and Allied Health Literature (CINAHL) for relevant studies?

4. Synthesis of strengths and weaknesses of available evidence

• Are the studies critically appraised and synthesized (Fawcett & Garity, 2009; Grove et al., 2013; Hart, 2009)? • Is a clear, concise summary presented of the current empirical and theoretical knowledge in the area of the study, including identifying what is known and not known (O’Mathuna, Fineout-Overholt, & Jonston, 2011)?

• Is the literature review organized to demonstrate the progressive development of evidence from previous research?

• Does the literature review summary provide direction for the formation of the research purpose?

168 CHAPTER 6 Literature Review

to the references included in the review of the literature, these authors cited references throughout

the research report. The reference list, previously formatted in the style of medical literature, is

included in APA format in this chapter. All the cited references are considered in the critical

appraisal.

RESEARCH EXAMPLE

Literature Review

“Anxiety is considered a normal part of the preoperative experience (Bailey, 2010). Because it is common,

however, does not mean it should be ignored. Part of the nurse’s role in the perioperative setting is to manage

patient anxiety to support positive surgical outcomes and satisfaction with the surgical experience. The shift

from inpatient hospital stays for surgery to same-day surgery has been monumental; most patients under-

going surgeries that once required an overnight hospital stay now go home within hours of surgery (Mitchell,

2003). Unfortunately, nurses and physicians have a fraction of the time they once had to achieve all of the

postoperative goals and outcomes, including, but not limited to, pain management and postoperative edu-

cation (Mitchell, 2003).

Grieve (2002) described causes of anxiety in the preoperative patient. . . . Yellen and Davis (2001)

reviewed the effects of anxiety and found that it can be detrimental to physical and emotional recovery,

and that anxiety can contribute to poor outcomes and longer hospitalizations. These researchers also learned

that when patients felt valued and attained a high level of comfort, these beliefs were strong predictors of

patient satisfaction.

Anxiety triggers the stress response, stimulating the release of epinephrine and norepinephrine, which

raises blood pressure and increases heart rate, cardiac output, and blood glucose levels (Forshee, Clayton, &

McCance, 2010). Poorly managed anxiety can be life-threatening in patients diagnosed with hypertension

and coronary artery disease, increasing the chances for myocardial infarction or potential stroke (Forshee,

Clayton, & McCance, 2010). Anxiety can also have a major effect on psychological symptoms and can inhibit

learning, concentration, and routine tasks (Gilmartin & Wright, 2008; Vaughn, Wichowski, & Bosworth,

2007). . . . Armed with this knowledge, nurses in the perioperative setting should be concerned about

how anxiety can affect the outcomes for all surgical patients.

There is a link between preoperative anxiety and postoperative pain. In their systematic review of pre-

dictors for postoperative pain, Ip et al. (2009) found that anxiety ranked as the highest predictor. . . . According

to Lin and Wang (2005), unrelieved postoperative pain has a negative effect on patients and delays postop-

erative recovery. In their literature review, Vaughn et al. (2007) found studies that correlated anxiety and pain,

and concluded that ‘preoperative planning for patients with high levels of anxiety should be implemented to

obtain optimal postoperative pain control’ (p. 601).

In her review of studies for strategies to decrease patient anxiety, Bailey (2010) found that perioperative

education and music therapy were successful. McRee et al. (2003) researched the use of music and mas-

sage as forms of improving postoperative outcomes. . . . The findings provided evidence that patients who

received preoperative music or music with massage had reduced anxiety, stress, and pain (McRee

et al., 2003).

In their review, Cooke et al. (2005) identified 12 studies that focused on the effect of music on anxiety in

patients waiting for surgery or other procedures in the ambulatory setting. . . . The studies of the effects of

music interventions in relation to anxiety and pain reduction have similar findings (Nilsson, 2008; Yung, Chui-

Kam, French, & Chan, 2002). . . . The types of music that are relaxing to patients may need to be individual-

ized, however, thus posing challenges to implementing this intervention.

Braden et al. (2009) studied the use of oil lavandin, which has relaxant and sedative effects, as a means

to reduce preoperative anxiety in surgical patients. . . . Similar to music, olfactory and topical application of oil

lavandin has a low risk of adverse effects and is a cost-effective intervention that has proven successful in

lowering patient anxiety on OR transfer (Braden et al., 2009). However, the use of essential oils may pose Continued

169CHAPTER 6 Literature Review

RESEARCH EXAMPLE—cont’d

challenges with infection control standards, which often specify the brand name (i.e., source) of lotion prod-

ucts that can be used in the healthcare facility.

Kim et al. (2001) researched the effects of preoperative hand massage on patient anxiety before

and during cataract surgery. . . . The researchers concluded that hand massage decreased the psycholog-

ical and physiological anxiety levels in patients having cataract surgery under local anesthesia (Kim

et al., 2001).

Of all the alternative methods used to alleviate anxiety in preoperative patients, we identified hand mas-

sage as a strategy that was consistent with the time constraints in the perioperative setting. Massage can be

readily learned by nursing personnel, surgical patients’ hands are easily accessible, and massage can be

accomplished in 10 minutes. We were curious to see whether hand massage would improve patient out-

comes and overall patient satisfaction. Results of previous research have shown that significant psycholog-

ical and physiological changes take place after a hand massage (Kim et al., 2001). Hand massage is also a

high-touch nursing care procedure that supports the concept of patients feeling valued and feeling the high-

est level of comfort during a time of stress and uncertainty.”

References Bailey, L. (2010). Strategies for decreasing patient anxiety in the perioperative setting. AORN Journal, 92(4),

445–457.

Braden, R., Reichow, S., & Halm, M. A. (2009). The use of the essential oil lavandin to reduce preoperative anx-

iety in surgical patients. Journal of Perianesthesia Nursing, 24(6), 348–355.

Chlan, L. L. (2004). Relationship between two anxiety instruments in patients receiving mechanical ventilatory

support. Journal of Advanced Nursing, 48(5), 493–499.

Cline, M. E., Herman, J., Shaw, E. R., & Morton, R. D. (1992). Standardization of the visual analog scale. Nursing

Research, 41(6), 378–380.

Cooke, M., Chaboyer, W., Schluter, P., & Hiratos, M. (2005). The effect of music on preoperative anxiety in day

surgery. Journal of Advanced Nursing, 52(1), 47–54.

Creating the patient experience. (2011). DeKalb, IL: Kish Health System.

D’Arcy, Y. (2011). Controlling pain. New thinking about fibromyalgia pain. Nursing, 41(2), 63–64.

Forshee, B. A., Clayton, M. F., & McCance, K. L. (2010). Stress and disease. In K. L. McCance, S. E. Huether,

V. L. Brashers & N. S. Rote (Eds.), Pathophysiology: The biologic basis for disease in adults and children (6th

ed., pp. 336–358). St. Louis, MO: Mosby.

Gilmartin, J., & Wright, K. (2008). Day surgery: Patients felt abandoned during the preoperative wait. Journal of

Clinical Nursing, 17(18), 2418–2425.

Grieve, R. J. (2002). Day surgery preoperative anxiety reduction and coping strategies. British Journal of Nursing,

11(10), 670–678.

Ip, H. Y., Abrishami, A., Peng, P. W., Wong, J., & Chung, F. (2009). Predictors of postoperative pain and

analgesic consumption. Anesthesiology, 111(3), 657–677.

Kim, M. S., Cho, K. S., Woo, H. M., & Kim, J. H. (2001). Effects of hand massage on anxiety in cataract surgery

using local anesthesia. Journal of Cataract and Refractive Surgery, 27(6), 884–890.

Leach, M., Zernike, W., & Tanner, S. (2000). How anxious are surgical patients? ACORN Journal, 13(1), 30–31,

34–35.

Lin, L. Y., & Wang, R. H. (2005). Abdominal surgery, pain and anxiety: Preoperative nursing intervention. Journal

of Advanced Nursing, 51(3), 252–260.

McRee, L. D., Noble, S., & Pasvogel, A. (2003). Using massage and music therapy to improve postoperative

outcomes. AORN Journal, 78(3), 433–447.

Mitchell, M. (2003). Patient anxiety and modern elective surgery: A literature review. Journal of Clinical Nursing,

1(6), 806–815.

Nilsson, U. (2008). The anxiety- and pain-reducing effects of music interventions: A systematic review. AORN

Journal, 87(4), 780–807.

170 CHAPTER 6 Literature Review

Oshodi, T. O. (2007). The impact of preoperative education on postoperative pain. British Journal of Nursing,

16(3), 790–797.

Quattrin, R., Zanini, A., & Buchini, S., et al. (2006). Use of reflexology foot massage to reduce anxiety in hospi-

talized cancer patients in chemotherapy treatment: Methodology and outcomes. Journal of Nursing Manage-

ment, 14(2), 96–105.

Salmore, R. G., & Nelson, J. P. (2000). The effect of preprocedure teaching, relaxation instruction and music on

anxiety as measured by blood pressures in an outpatient gastrointestinal endoscopy laboratory. Gastroenter-

ology Nursing, 23(3), 102–110.

Statistical package for the social sciences. Version 18.0. (2008). Chicago, IL: SPSS, Inc.

Vaughn, F., Wichowski, H., & Bosworth, G. (2007). Does preoperative anxiety level predict postoperative pain?

AORN Journal, 85(3), 589–604.

Wang, S. M., Caldwell-Andrews, A., & Kain, Z. N. (2003). The use of complementary and alternative medicines

by surgical patients: A follow-up survey study. Anesthesia and Analgesia, 97(4), 1010–1015.

Wagner, D., Byrne, M., & Kolcaba, K. (2003). Effects of comfort warming on perioperative patients. AORN Jour-

nal, 84(3), 427–448.

Watson, J. (2008). Nursing. The philosophy and science of caring (revised ed.). Boulder, CO: University Press of

Colorado.

Williams, V. S., Morlock, R. J., & Feltner, D. (2010). Psychometric evaluation of a visual analog scale for the

assessment of anxiety. Health and Quality of Life Outcomes, 8, 57. Available from http://www.hqlo.com/

content/8/1/57.

Yellen, E., & Davis, G. (2001). Patient satisfaction in ambulatory surgery. AORN Journal, 74(4), 483–498.

Yung, P. M., Chui-Kam, S., French, P., & Chan, T. (2002). A controlled trial of music and pre-operative anxiety in

Chinese men undergoing transurethral resection of the prostate. Journal of Advanced Nursing, 39(4), 352–359.

Critical Appraisal 1. Inclusion of Relevant Literature Brand and colleagues (2013) cited 28 references in their research report, including 15 research or data-based papers.

Three of these were reviews synthesizing findings of several studies on the topic. Watson’s theory of caring (2008)

was the only theoretical source cited, but Brand and associates did reference Forshee and co-workers (2010), a chap-

ter in a pathophysiological book. Pathophysiological principles can be considered scientific theory. In the literature

review section, Brand and colleagues described four studies in detail because these studies were the most pertinent to

the research problem. They also cited the statistical software that was used, two clinical summaries of anxiety-

minimizing nursing interventions, and three journal articles to support the reliability, validity, and scoring of

the visual analog (also spelled analogue) scale used to measure anxiety.

2. Currency of Sources Twenty (71%) of the references were published in the past 10 years (in or since 2003) and 10 (36%) were published in

the past 5 years (in or since 2008). Brand and associates (2013) cited Cline and co-workers (1992) to support how to

use the visual analog scale. Cline and colleagues (1992) is a landmark article and the authority on scoring visual

analog scales. The only concern is that four of the articles cited as research findings were older than 10 years. A

search of CINAHL revealed four articles published since 2009 about hand massage and stress that were not included

in the reference list, but none specifically addressed hand massage and anxiety.

3. Breadth of the Review The journals cited were primarily nursing journals (20 of 24 journal citations), and most authors were nurses. The

nursing journal citations were split evenly between journals published in the United States and journals published in

Britain. Three of the non-nursing journals were medical and one was a journal with a focus on health quality of life

outcomes. The researchers searched databases other than CINAHL, because not all the cited publications are

included in CINAHL. A search of four other health-related databases only revealed one additional article with pos-

sible relevance for the study. Continued

171CHAPTER 6 Literature Review

Critical Appraisal of a Literature Review in a Qualitative Study In Chapter 3, a qualitative study conducted by Trollvik, Nordbach, Silen, and Ringsberg (2011) was

used as an example of phenomenology. The research report of their study of children’s perceptions

of living with asthma does not have a section titled “Literature Review.” Trollvik and colleagues

(2011) cited references primarily in the background and discussion sections. The background sec-

tion and reference list are included here as an example of critical appraisal of the literature review in

a qualitative study (pp. 295-296, 303). The discussion section was not included because the focus of

this chapter is on the literature review.

RESEARCH EXAMPLE—cont’d

4. Synthesis of Strengths and Weaknesses of Available Evidence In the review, Brand and associates (2013) indicated the studies that included random assignment to groups were an

indication of more rigorous study designs. As noted, they cited three research reviews and indicated the number of

studies in each review. They focused their discussion of the studies, however, on the applicability and feasibility of

using the interventions, rather than on the strength of the studies.

The review was organized with the first paragraph describing the changes that have occurred in health care that

made this an important study to conduct. Subsequent paragraphs reviewed the literature related to causes and effects

of anxiety, the negative consequences of anxiety, and the connection between preoperative anxiety and postoperative

pain. The last half of the review consisted of the research on the effects of anxiety-reducing interventions. Brand and

co-workers (2013) concluded the review by providing their rationale for using hand massage as an intervention for

preoperative and preprocedure anxiety. They did note that previous studies had indicated that “significant psycho-

logical and physiological changes take place after hand massage” (p. 710). The review provided a logical argument

supporting the selection of the intervention for the study and the purpose of the study. The logical argument is a

strength of the review, which was longer than is often allowed in a journal. The review could have been strengthened

by Brand and colleagues (2013) by providing critical appraisal information about the cited studies and identifying

the type of research syntheses included, such as a systematic review or meta-analysis (see Chapters 1 and 13).

Summary of the Study and Its Findings Brand and associates (2013) developed a hand massage procedure and a script for obtaining informed consent.

Nurses were trained to do hand massage following the procedure. Of the 101 recruited subjects, 15 (14%) did

not complete the post-test measurement, resulting in a sample of 86 subjects with complete data. The change in

the pretest and post-test anxiety level of subjects in the intervention group (n¼45) was statistically significant. The change in pretest and post-test anxiety of subjects in the control group (n¼41) was not statistically significant. Pretest anxiety levels of the two groups were statistically equivalent. However, the difference in post-test anxiety

levels of the intervention group and control group was statistically significant, indicating that hand massage reduced

anxiety. An unexpected observation was that the insertion of the preoperative intravenous access was easier to com-

plete in the intervention group, explained as being a result of the hand massage warming the hands and causing

vasodilation. Brand and co-workers (2013) recommended future multisite studies with larger and more culturally

and gender diverse samples.

Implications for Practice One relatively small study is not adequate evidence to support a recommendation for using hand massage to lower

anxiety in all preoperative patients. Hand massage, however, has few contraindications and is a low-cost, easily

implemented intervention within the scope of nurses. Individual nurses might choose to learn hand massage tech-

niques and use the intervention in practice to reduce the anxiety of preoperative patients. Consistent with Quality

and Safety Education for Nurses (QSEN) competencies, using hand massage to reduce anxiety in preoperative

patients is an example of providing patient-centered care and contributing to safety by reducing the likelihood

of anxiety-related complications in cardiac patients undergoing day surgery (QSEN, 2013).

172 CHAPTER 6 Literature Review

RESEARCH EXAMPLE

Example Literature Review (2011)

Background “Asthma is the most common childhood disease and long-term medical condition affecting children (Masoli,

Fabian, Holt, Beasley, & Global Initiative for Asthma [GINA] Program, 2004). The prevalence of asthma is

increasing, and atopic diseases are considered to be a worldwide health problem and an agent of morbidity

in children (Masoli et al., 2004). A Norwegian cohort study among 10-year-old children concluded that lifetime

prevalence of asthma was 20.2%, current asthma was 11.1%, and doctor diagnosis of asthma was 16.1%,

the highest number ever reported in Scandinavia; boys are more affected than girls (Carlsen et al., 2006). A

Nordic study of children aged 2-17 years found that asthma, allergies, and eczema were the most commonly

reported long-term illnesses (Berntsson, 2000). Many children and their families are thus affected by asthma

directly or indirectly. Rydström, Englund, and Sandman (1999) found that children with asthma show signs of

uncertainty, guilt, and fear and sometimes they felt like participants, other times like outsiders, in everyday

life. Studies show that children with asthma have more emotional/behavioral problems than healthy children

(Reichenberg & Broberg, 2004). Chiang, Huang, and Fu (2006) observed that children with asthma, especially

girls, participate less in physical activity. It has also been found that asthma control in children is poor and that

health care professionals (HCPs) and children focus on different aspects of having asthma (Price et al., 2002);

HCPs focus on symptoms, whereas children focus on activity limitations. Guyatt, Juniper, Griffith, Feeny, and

Ferrie (1997) stated that children as young as 7 years are able to accurately report changes in symptoms for

periods as long as 1 month. These studies, however, are mainly from a caregiver’s perspective than from the

perspective of the child’s own experience. Few studies have considered very young children’s, 7-10 years

old, perspectives; this study might contribute to new insights into their lifeworld experiences. The aim of the

study was to explore and describe children’s everyday experiences of living with asthma to tailor an Asthma

Education Program based on their perspectives.”

References “Antonovsky, A. (1996). The salutogenic model as a theory to guide health promotion. Health Promotion

International, 11, 11�18. http://dx.doi.org/10.1093/heapro/11.1.7. Berntsson, L. (2000). Health and well-being of children in the five Nordic countries in 1984 and 1996.

(Doctoral thesis). Gothenburg, Sweden: Nordic School of Public Health.

Canham, D. L., Bauer, L., Concepcion, M., Luong, J., Peters, J., & Wilde, C. (2007). An audit of medi-

cation administration: A glimpse into school health offices. Journal of School Nursing, 23, 21�27. http://dx. doi.org/10.1177/10598405070230010401.

Carlsen, K., Haland, G., Devulapalli, C., Munthe-Kaas, M., Pettersen, M., Granum, B., et al. (2006).

Asthma in every fifth child in Oslo, Norway: A 10-year follow up of a birth cohort study. Allergy: European

Journal of Allergy & Clinical Immunology, 61, 454�460. http://dx.doi.org/10.1111/j.1398- 9995.2005.00938. Chiang, L. C., Huang, J. L., & Fu, L. S. (2006). Physical activity and physical self-concept: Comparison

between children with and without asthma. Journal of Advanced Nursing, 54, 653�662. http://dx.doi.org/ 10.1111/ j.1365-2648.2006.03873.

Christensen, P., & James, A. (2008). Research with children. Perspectives and practices (2nd ed.).

London: Routledge.

Dahlberg, K. M. E., & Dahlberg, H. K. (2004). Description vs. interpretation—A new understanding of an

old dilemma in human research. Nursing Philosophy, 5, 268�273. http://dx.doi.org/10.1111/j.1466-769X. 2004.00180.

Darbyshire, P., MacDougall, C., & Schiller, W. (2005). Multiple methods in qualitative research with

children: More insight or just more? Qualitative Research, 5, 417. http://dx.doi.org/10.1177/

1468794105056921. Continued

173CHAPTER 6 Literature Review

RESEARCH EXAMPLE—cont’d

Driessnack, M. (2005). Children’s drawings as facilitators of communication: A meta-analysis. Journal of

Pediatric Nursing, 20, 415�423. http://dx.doi.org/10.1016/j.pedn.2005.03.011. Guyatt, G. H., Juniper, E. F., Griffith, L. E., Feeny, D. H., & Ferrie, P. J. (1997). Children and adult

perceptions of childhood asthma. Pediatrics, 99, 165�168. http://dx.doi.org/10.1542/peds.99.2.165. Hummelvoll, J. K., & Barbosa da Silva, A. (1998). The use of the qualitative research interview to uncover

the essence of community psychiatric nursing. Journal of Holistic Nursing, 16, 453�477. http://dx.doi.org/ 10.1177/089801019801600406.

Kirk, S. (2007). Methodological and ethical issues in conducting qualitative research with children and

young people: A literature review. International Journal of Nursing Studies, 44, 1250�1260. http://dx.doi. org/10.1016/j.ijnurstu.2006.08.015.

Kvale, S. (1997). Interviews. An introduction to qualitative research interviewing. London: Sage

Publications.

Masoli, M., Fabian, D., Holt, S., Beasley, R., & Global Initiative for Asthma (GINA) Program. (2004). The

global burden of asthma: Executive summary of the GINA Dissemination Committee Report. Allergy, 59,

469�478. http://dx.doi.org/10.1111/j.1398-9995.2004.00526. McCann, D., McWhirter, J., Coleman, H., Devall, I., Calvert, M., Weare, K., et al. (2002). The prevalence

and management of asthma in primary-aged schoolchildren in the south of England. Health Education

Research, 17(2), 181�194. Merleau-Ponty, M. (2004). Phenomenology of perception. London: Routledge.

Patton, M. Q. (2002). Qualitative research and evaluation methods (3rd ed.). Thousand Oaks, CA: Sage

Publications.

Price, D., Ryan, D., Pearce, L., Bawden, R., Freeman, D., Thomas, M., et al. (2002). The burden of pae-

diatric asthma is higher than health professionals think: Results from the Asthma In Real Life (AIR) study.

Primary Care Respiratory Journal, 11(2), 30�33. Reichenberg, K., & Broberg, A. (2004). Emotional and behavioural problems in Swedish 7- to

9-year olds with asthma. Chronic Respiratory Disease, 1, 183�189. http://dx.doi.org/10.1191/ 1479972304cd041oa.

Rootman, I., Goodstadt, M., Hyndman, B., McQueen, D., Potvin, L., & Springett, J. (2001). Evaluation in

health promotion: Principles and perspectives. Copenhagen: WHO Regional Office Europe.

Rydström, I., Englund, A. C., & Sandman, P. O. (1999). Being a child with asthma. Pediatric Nursing,

25(6), 589–90, 593–596.

Sällfors, C., Hallberg, L., & Fasth, A. (2001). Coping with chronic pain: In-depth interviews with children

suffering from juvenile chronic arthritis. Scandinavian Journal of Disability Research, 3, 3�20. http://dx.doi. org/10.1080/15017410109510765.

The Act of 2 July 1999 No. 63 relating to Patients’ Rights (the Patients’ Rights Act). (1999). Norwegian

government. Retrieved March 16, 2010 from http://www.ub.uio.no/ujur/ulovdata/lov-19990702-063-eng.

pdf.

Trollvik, A., & Severinsson, E. (2005). Influence of an Asthma Education Program on parents with chil-

dren suffering from asthma. Nursing & Health Sciences, 7, 157–163. http://dx.doi.org/10.1111/j.1442-2018.

2005.00235.

UNICEF. (2008). Convention on the rights of the child. Retrieved May 20, 2010 from http://www2.ohchr.

org/english/law/pdf/crc.pdf.

Woodgate, R. (2009). The experience of dyspnea in school-age children with asthma. American Journal

of Maternal/Child Nursing, 34, 154�161. http://dx.doi.org/10.1097/01.NMC.0000351702.58632.9e. Williams, C. (2000). Doing health, doing gender: Teenagers, diabetes and asthma. Social Science &

Medicine, 50, 387�396. http://dx.doi.org/10.1016/S0277- 9536(99)00340-8.” Trollvik et al., 2011, p. 303

174 CHAPTER 6 Literature Review

Critical Appraisal

1. Inclusion of Relevant Literature

Of the 27 references cited by Trollvik and associates (2011) in their research report, 15 (55%) were citations of

studies or database sources. Most of the total references (70%) were journal articles. One theoretical source

(Antonovky, 1996), the oldest reference, was cited in the discussion as an explanation of one of the findings.

A theoretical framework was not identified, as is often the case with phenomenological studies (Munhall, 2012).

Trollvik and co-workers (2011) described the philosophical orientation and qualitative approach of phenome-

nology in the methods section. Four books and one statistical analysis software were cited in the methods sec-

tion. A government website and a website of an international organization were cited as well.

2. Currency of Sources

Eight citations were publications older than 10 years. The remainder (70%) were cited in the 10 years prior to the

article’s publication (in or since 2001), but only seven publications (26%) were cited in the 5 years prior to the

publication (in or since 2006). Because qualitative researchers often study topics that have been rarely researched,

it is not uncommon for the literature they cite to be older. As noted earlier, Antonovsky (1996) was the oldest ref-

erence cited. Inclusion of this older article is appropriate because his theory was a landmark publication and was one

of the first theories to describe health as more than the absence of disease.

3. Breadth of the Review

The authors and journals cited were from multiple disciplines, with nursing journals cited seven times and medical

journals cited eight times. The researchers had searched databases outside of nursing to find these references. The

multidisciplinary nature of the journals cited are an indication that other health professionals and scientists from

other disciplines authored the cited publications.

4. Synthesis of Strengths and Weaknesses of Available Evidence

Although Trollvik and colleagues (2011) included little detail about the strengths and weaknesses of the cited stud-

ies, they did acknowledge, as a major threat to the validity of previous studies, that the studies had been conducted

on the perspective of parents, rather than the children living with asthma. Selected studies were reviewed prior to the

discussion of the method, with additional references cited in the discussion of the findings. Trollvik and associates

(2011) clearly described the need for the study in terms of disease prevalence. The last few sentences of the back-

ground section identified the research problem as the logical conclusion of the review. The research problem was

directly linked to the purpose of the study and the potential contribution of the study’s findings.

Summary of the Study and Its Findings In interviews, 15 children were asked to describe their experiences with asthma in daily life. The interviewers also

asked the children to describe their feelings and body sensations of asthma and how they communicated with

teachers and peers about having asthma. Of these children, 14 drew a picture about living daily with asthma as

another source of data. Trollvik and co-workers (2011, p. 297) found two major themes, “fear of exacerbation

and fear of being ostracized.” See Chapter 3 for more information about the study.

Implications for Practice Trollvik and colleagues (2011, p. 302) identified that “using drawing . . . is a good tool for initiating a dialogue and gaining access to children’s inner thoughts.” They also emphasized the need to develop asthma patient education in

collaboration with children with asthma to ensure that the education meets their needs. Including patients in the

developing of teaching materials is an example of incorporating the QSEN competency of patient-centered care into

practice (QSEN, 2013).

175CHAPTER 6 Literature Review

REVIEWING THE LITERATURE

Reviewing the literature is a frequent expectation in nursing education programs. Students may

be overwhelmed and intimidated by this expectation, concerns that can be overcome with infor-

mation and a checklist of steps to follow in the process. The steps of the literature review checklist

(Box 6-1) will be discussed; these provide an outline for the rest of the chapter. In addition, this

section will include common student questions and provide answers.

Preparing to Review the Literature Preparation before a complex task can give structure to the process and increase the efficiency

and effectiveness of the efforts that will be made. This section provides information about the

purpose of a literature review and selecting the databases to be searched, the first two steps listed

in Box 6-1.

Clarify the purpose of the literature review. Your approach to reviewing the literature will vary according to the purpose of the review. Reviewing the literature for a course assignment requires

a clear understanding of the assignment. These reviews will vary depending on the level of edu-

cational program, purpose of the assignment, and expectations of the instructor. The literature

review for an introduction to a nursing course would be of lesser scope and depth than a literature

review for a senior-level nursing course or graduate course (Hart, 2009). For a paper, your instruc-

tor may specify the publication years and type of literature to be included. Also, note the acceptable

length of the written review of the literature to be submitted. Usually, the focus of course assign-

ment literature reviews will be a summary of information on the selected topic and the implica-

tions of the information for clinical practice.

Students repeatedly ask, “How many articles should I have? How far back in years should I go to

find relevant information?” The answer to both those questions is an emphatic “It depends.”

BOX 6-1 STEPS OF THE LITERATURE REVIEW CHECKLIST

A. Preparing to review the literature

1. Clarify the purpose of the literature review.

2. Select electronic databases and search terms.

B. Conducting the search

3. Search the selected databases.

4. Use a table to document the results of your search.

5. Refine your search.

6. Review the abstracts to identify relevant studies.

7. Obtain full-text copies of relevant articles.

8. Ensure that information needed to cite the source is recorded.

C. Processing the literature

9. Read the articles.

10. Appraise, analyze, and synthesize the literature.

D. Writing the review of the literature

11. Develop an outline to organize information from the review.

12. Write each section of the review.

13. Create the reference list.

14. Check the review and the reference list.

176 CHAPTER 6 Literature Review

Faculty for undergraduate courses may provide you with guidelines about the number and type of

articles you are required to include in an assignment or project. Graduate students are expected to

conduct a more extensive review for course papers and research proposals for theses or disserta-

tions. How far back in the literature you need to search depends on the topic. You need to locate the

seminal and landmark studies and other relevant sources in the field of interest. A librarian or

course faculty member may be able to assist you in determining the range of years to search

for a specific topic.

Another reason you may be conducting a review of the literature is to examine the strength of

the evidence and synthesize the evidence related to a practice problem. Evidence-based practice

guidelines are developed through the synthesis of the literature on the clinical problem. The pur-

pose of the literature review is to identify all studies that included a particular intervention, crit-

ically appraise the quality of each study, synthesize all the studies, and draw conclusions about the

effectiveness of a particular intervention. When available, replication studies, systematic reviews,

meta-analyses, meta-syntheses, and mixed-methods systematic reviews are important publications

to include. It is also important to locate and include previous evidence-based papers that examined

the evidence of a particular intervention, because the conclusions of these authors are highly rel-

evant. Other types of literature syntheses related to promoting evidence-based nursing practice are

described in Chapter 13.

Select electronic databases and search terms. Because electronic access to the literature is so readily available, reviewing the literature can be overwhelming. General search engines such as

Google, Google Scholar, or Yahoo will identify scholarly publications, but often the sources you

identify in this way will be older and not current. To find current literature, learn to use comput-

erized bibliographic databases, such as CINHAL and Science Direct. These are valuable tools to

search for relevant empirical or theoretical literature easily, but different databases contain cita-

tions for articles from different disciplines. Table 6-1 includes electronic databases valuable for

nursing literature reviews. Depending on the focus of your review, you will select databases to

search.

TABLE 6-1 DATABASES FREQUENTLY USED FOR NURSING LITERATURE REVIEWS

NAME OF DATABASE DATABASE CONTENT

Cumulative Index of Nursing and

Allied Health Literature (CINAHL)

Nursing and allied health journals that publish clinical, theoretical, and

research articles, including many full-text articles

MEDLINE Biomedical journals relevant to healthcare professionals deemed

reputable by the National Library of Medicine; includes abstracts with

links to some full-text sources

PubMed Free access to MEDLINE available to patients and other consumers

PsychARTICLES Journals published by the American Psychological Association (APA) and

affiliated organizations

Academic Search Complete Multidisciplinary databases, including articles from many disciplines

Health Source: Nursing/Academic

Edition

Journals published for physicians, nurses, and other healthcare

professionals; includes many full-text articles and medication education

materials for patients

Psychological and Behavioral

Sciences Collection

Psychiatry, psychology, and behavioral health journals

177CHAPTER 6 Literature Review

Searching professional electronic databases has many advantages, but one challenge is that you

will have to select relevant sources from a much larger number of articles. You can narrow the

number of articles and retrieve fewer but relevant articles by using keywords to search. Keywords

are terms that serve as labels for publications on a topic. For example, a quasi-experimental study

of providing text message reminders to patients living with heart failure who are taking five or

more medications might be found by searching for keywords, such as electronic communication,

instant messaging, medication adherence, patient teaching, quasi-experimental designs, and heart

failure. When you find one article on your topic, look under the abstract to determine whether the

search terms are listed. Using search terms or keywords to search is a skill you can teach yourself,

but also remember that a librarian is an information specialist. Consulting a librarian may save you

time and make searching more effective.

Conducting the Literature Review Search the selected databases. The actual search of the databases may be the easiest step of the

process. One method of decreasing the time to search is to search multiple databases simulta-

neously, an approach that is possible when several databases are available within a search engine,

such as Elton B. Stephens Company host (EBSCOhost). To avoid duplicating your work, keep a list

of searches that you have completed. This is especially important if you have limited time and will

be searching in several short sessions, instead of one long one.

Use a table or other method to document the results of your search. A very simple way to doc- ument your search is to use a table, such as that shown in Table 6-2. On the table, you will record

the search terms, time frame you used, and the results. With most electronic databases, you can

sign up for an account and keep your search history. Reference management software, such as

RefWorks (http://www.refworks.com) and EndNotes (http://www.endnote.com), can make

tracking the references you have obtained through your searches considerably easier. You can

use reference management software to conduct searches and store the information on all search

fields for each reference obtained in a search. Within the software, you can store articles in folders

with other similar articles. For example, you may have a folder for theory sources, another

for methodological sources, and a third for relevant research topics. As you read the articles,

you can also insert comments into the reference file about each one. By exporting search results

from the bibliographic database to your reference management software, all the needed citation

information and abstract are readily available to you electronically when you write the literature

review.

Refine your Search. As seen in Table 6-2, a search may identify thousands of references, many more than you can read and include in any literature review. Open a few articles that were iden-

tified and see what key terms were used. Reconsider the topic and determine how you can narrow

TABLE 6-2 RECORD OF SIMPLE LITERATURE SEARCH FOR PATIENT SAFETY

DATABASE SEARCHED

DATE OF

SEARCH

SEARCH

TERMS YEARS

NO. OF SOURCES

FOUND

CINAHL Complete 8/10/2013 Patient safety 2003-2013 28,842

Academic Search Complete 8/10/2013 Patient safety 2003-2013 17,745

Health Source: Nursing/Academic Edition 8/10/2013 Patient safety 2003-2013 7,392

178 CHAPTER 6 Literature Review

your search. One strategy is to decrease the range of years you are searching. Some electronic data-

bases allow you to limit the search to certain types of articles, such as scholarly, peer-reviewed arti-

cles. Combining terms or searching for the terms only in the abstracts will decrease the number

of articles identified. For undergraduate course assignments, it may be appropriate to limit the

search to only full-text articles. The recommendation would be, however, that graduate students

avoid limiting searches to full-text articles because doing so might result in missing sources that

are needed. Table 6-3 provides the results of patient safety searches in CINAHL using different

strategies, including an example of narrowing a search tightly and ending up with few results.

When that occurs, you can retry the search with one or more search terms and limitations

removed.

Review the abstracts to identify relevant studies. The abstract provides pertinent information about the article. You can easily determine if the article is a research report, description of a clinical

problem, or theoretical article, such as a concept analysis. You will identify the articles that seem to

be the most relevant to your topic and the purpose of the review. If looking for evidence on which

to base clinical practice, you can identify the research reports and select those conducted in settings

similar to yours. If writing a literature review for a course assignment, you will review the abstracts

to identify different types of information. For example, you may need information on mortality

and morbidity, as well as descriptions of available treatments. Mark the abstracts of the relevant

studies or save in an electronic folder.

Obtain full-text copies of relevant articles. Using the abstracts of relevant articles, you will retrieve and save the electronic files of full-text articles on your computer to review more thor-

oughly. You may want to rename the electronic file using a file name that includes the first author’s

last name and the year or a file name with a descriptive phrase. For articles not available as full-text

online, you will search your library’s holdings to determine if the journal is available to you in print

form. If your library does not have the journal, you may be able to obtain the article through

TABLE 6-3 RESULTS OF REFINED SEARCHES FOR PATIENT SAFETY SOURCES

DATABASE

SEARCHED

DATE OF

SEARCH SEARCH TERMS AND STRATEGY YEARS

NO. OF

SOURCES

FOUND

CINAHL Complete 8/10/2013 • Patient safety 2008-2013 18,788

CINAHL Complete 8/10/2013 • Patient safety and nurses 2008-2013 2,917

CINAHL Complete 8/10/2013 • Patient safety and nurses

• Abstracts only

2008-2013 846

CINAHL Complete 8/10/2013 • Patient safety and nurses

• Abstracts only

• Limited to full text available

2008-2013 336

CINAHL Complete 8/10/2013 • Patient safety and nurses and older adults

• Abstracts only

• Limited to full text available

2008-2013 2

CINAHL Complete 8/10/2013 • Patient safety and nurses and older adults

• Limited to full text available

2008-2013 8

CINAHL Complete 8/10/2013 • Patient safety and older adults

• Limited to full text available

2008-2013 36

179CHAPTER 6 Literature Review

interlibrary loan. Check with your library’s website or a librarian to learn the process for using the

interlibrary loan system. If you prefer reading print materials to electronic materials, you may

choose to print the articles. It is important to obtain the full-text of the article because the abstract

does not include the detail needed for a literature review.

Ensure that information needed to cite the source is recorded. As you retrieve and save the articles, note if the article includes all the information needed for the citation. The bibliographic

information on a source should be recorded in a systematic manner, according to the format that

you will use in the reference list. The purpose for carefully citing sources is that readers can retrieve

the reference for themselves, confirm your interpretation of the findings, and gather additional

information on the topic. You will need the authors’ names, year, article title, journal name, journal

volume and issue, and page numbers. If a book chapter has been photocopied or retrieved elec-

tronically, ensure that the publisher’s name, location, and year of publication are recorded. Notice

specifically whether the chapter is in an edited book and if the chapter has an author other than the

editor. If you are using an electronic personal bibliographic software such as RefWorks, the soft-

ware records the citation information for you.

Processing the Literature Processing the literature is among the more difficult phases of the literature review. This section

includes reading the articles and appraising, analyzing, and synthesizing the literature.

Read the articles. As you look at the stack of printed articles or scan the electronic copies of several articles, you may be asking yourself, “Am I expected to read every word of the available

sources?” The answer is no. Reading every word of every source would result in you being well

read and knowledgeable, but with no time left to prepare the course assignment or paper. With

the availability of full-text online articles, you can easily forget the focus of the review. Becoming

a skilled reviewer of the literature involves finding a balance and learning to identify the most per-

tinent and relevant sources. On the other hand, you cannot critically appraise and synthesize what

you have not read. Skim over information provided by the author that is not relevant to your task.

Learn what is normally included in different sections of an article so you can read the sections

pertinent to your task more carefully. Chapter 2 provides you with ideas on how to read the

literature.

Comprehending and critically appraising sources leads to an understanding of the current state

of knowledge related to a research problem. Although you may skim or only read selected sections

of some references that you find, you will want to read the articles most relevant to your topic word

for word and probably more than once. Comprehending a source begins by reading and focusing

on understanding the main points of the article or other sources. Highlight the content you con-

sider important or make notes in the margins. Record your notes on photocopies or electronic files

of articles. The type of information you highlight or note in the margins of a source depends on the

type of study or source. With theory articles, you might make note of concepts, definitions, and

relationships among the concepts. For a research article, the research problem, purpose, frame-

work, major variables, study design, sample size, measurement methods, data collection, analytical

techniques, results, and findings are usually highlighted. You may wish to record quotations

(including page numbers) that might be used in a review of a literature section. The decision

to paraphrase these quotes can be made later. Also make notes about what you think about the

article, such as how this content fits with other information that you have read.

Appraise, analyze, and synthesize the literature. Analysis is required to determine the value of a reference as you make the decision about what information to include in the review. First, you need

to appraise the individual studies critically. The process of appraising individual studies is

180 CHAPTER 6 Literature Review

discussed in Chapter 12. To appraise the article critically, you will identify relevant content in the

articles and make value judgments about their validity or credibility. However, the critical appraisal

of individual studies is only the first step in developing an adequate review of the literature. Any

written literature review that simply appraises individual studies paragraph by paragraph is inad-

equate. A literature review that is a series of paragraphs, in which each paragraph is a description of

a single study, with no link to other studies being reviewed, does not provide evidence of adequate

analysis of the literature. Refer to the paragraph on preoperative anxiety and postoperative pain in

Trollvik and colleagues’ (2011) example presented earlier in the chapter. In this paragraph, the

researchers described and compared the findings of three studies on the topic, an example of sum-

marizing and synthesizing.

Analysis requires manipulation of what you are finding, literally making it your own (Garrard,

2011). Pinch (1995, 2001) was the first nurse to publish a strategy to synthesize research findings

using a literature summary table. More recently, Kable, Pich, and Maslin-Prothero (2012) pre-

sented a table to organize studies that are reviewed for possible inclusion into a proposal

(Table 6-4). Other examples of literature summary tables are provided in Tables 6-5 and 6-6

to demonstrate how the column headers might vary, depending on the type of research.

Table 6-5 contains information from the Brand and associates’ (2013) article as an example of

using the table. The content in Table 6-6 is from Trollvik and co-workers (2011). If using refer-

ence management software, it may allow you to generate summary tables from information you

record about each study. Another way to manipulate the information you have retrieved and

transform it into knowledge is known as mapping (Hart, 2009). Your nursing faculty may have

taught you how to map conceptually what you are studying to make connections between facts

and principles (Vacek, 2009). The same strategy applied to a literature review is to classify the

sources and arrange them into a graphic or diagrammatic format that requires you to become

familiar with key concepts (Hart, 2009). The map may connect studies with similar methodol-

ogies or key ideas.

As you continue to analyze the literature you have found, you will make comparisons among the

studies. This analysis allows you to appraise the existing body of knowledge critically in relation to

the research problem. You may want to record theories that have been used, methods that have

been used to study the problem, and any flaws with these theories and methods. You will begin

to work toward summarizing what you have found by describing what is known and what is

not known about the problem. The information gathered by using the table formats shown in

Tables 6-5 and 6-6 or displayed in a conceptual map can be useful in making these comparisons.

Pay special attention to conflicting findings, because they may provide clues for gaps in knowledge

that represent researchable problems.

TABLE 6-4 EXAMPLE OF LITERATURE SUMMARY TABLE FOR STUDIES

AUTHOR

(YEAR), AND

COUNTRY

STUDY

DESIGN

SAMPLE SIZE

AND SITE

COMMENTS AND

KEY FINDINGS

QUALITY APPRAISAL:

INCLUDE, EXCLUDE

____________ ______________ ________________ ___________________ _______________________

____________ ______________ ________________ ___________________ _______________________

Adapted from Kabe, A., Pich, J. & Maslin-Prothero, S. (2012). A structured approach to documenting a search strategy for

publication: A 12-step guideline for authors. Nurse Education Today, 32(8), 882.

181CHAPTER 6 Literature Review

TABLE 6-5 LITERATURE SUMMARY TABLE FOR QUANTITATIVE STUDIES

AUTHOR,

YEAR PURPOSE FRAMEWORK SAMPLE MEASURES TREATMENT RESULTS FINDINGS

Brand

et al.,

2013

“Determine the

effects of hand

massage on

patient anxiety in

the ambulatory

surgery setting”

(p. 708).

Watson’s

human caring

theory

86 patients Demographic

data;

VAS for

anxiety

Hand massage Intervention

group had

significantly

lower anxiety

(t¼4.85; p¼.000).

“Pre-operative

hand massage

has a significant

effect on patient-

reported anxiety”

(p. 715).

_________ _________________ _____________ _________ ____________ _____________ ______________ ________________

_________ _________________ _____________ _________ ____________ _____________ ______________ ________________

TABLE 6-6 LITERATURE SUMMARY TABLE FOR QUALITATIVE STUDIES

AUTHOR

AND

YEAR PURPOSE

QUALITATIVE

APPROACH SAMPLE

DATA

COLLECTION KEY FINDINGS COMMENTS

Trollvik

et al.

(2011)

“Explore children’s

experiences of

asthma to tailor a

learning program

based on their

perspectives”

(p. 295).

Phenomenology 14 children with

asthma, 9

boys and 6

girls

Interviews.

Drawing by

the child of a

situation

described in

the interview

Fear of exacerbation

(subthemes of bodily

sensations, frightening

experiences, loss of

control)

Fear of being ostracized

(subthemes of being

excluded, dilemma about

keeping asthma a secret)

Supports need

for including

children in

developing of

patient

education

__________ ___________________ ______________ ______________ _____________ _________________________ ______________

__________ ___________________ ______________ ______________ _____________ _________________________ ______________

The sources to be included in your research proposal can be organized by the section in which

you plan to cite them. For example, sources that provide background and significance for the study

are included in the introduction. You may decide to include theoretical sources to describe the

framework for the study. Methodologically strong studies may be cited to support the development

of the research design, guide the selection of data collection, whether by survey or interview, and

plans for data analysis.

The synthesis of sources involves thinking deeply about what you have found and identifying

the main themes of information that you want to present. Through synthesis, you will cluster and

describe connections among what you have found (Hart, 2009). From the clusters of connections,

you can begin to draw some conclusions about what is known and make additional connections to

the topic being studied. Note these sentences from the review of the literature in the Brand and

colleagues’ (2013) article: “Anxiety can also have a major effect on psychological symptoms and

can inhibit learning, concentration, and routine tasks (Gilmartin & Wright, 2008; Vaughn,

Wichowski, & Bosworth, 2007). Keeping anxiety to a minimum is important because, if patients

are anxious, then they may not be able to retain important home care instructions” (Brand et al.,

2013, p. 709). Brand and associates (2013) synthesized information from two articles to make a

conclusion and link the information to the significance of studying anxiety in this population.

One strategy for synthesizing is to review the tables or mind maps that you have developed and

make a list of findings that are similar and those that are different. For example, you have read five

intervention studies of end-of-life care in children with leukemia. As you review your notes, you

notice that four studies were conducted in home settings with samples of children from ages 7 to

10 years and had similar statistically significant results when using a parent-administered interven-

tion. The remaining study, with nonsignificant results, also used a parent-administered interven-

tion, but was set in an inpatient hospice unit and had a sample of younger children. The main ideas

that you identify may be that the effectiveness of parent-administered interventions may vary,

depending on the setting and age of the child. Another strategy for synthesis is to talk about

the articles you have reviewed with another student, nurse, or friend. Verbalizing the characteristics

of the studies and explaining them to another person can cause you to think differently about the

studies than you do when you are reading your notes. Your enhanced thinking may result in the

identification of main ideas or conclusions of the review.

Writing the Review of the Literature Talking about the main ideas of the review can prepare you for the final steps of writing the lit-

erature review. Step 11 is organizing your information by developing an outline prior to writing the

major sections of the review. The final steps are creating the reference list and checking the review

and reference list for correctness.

Develop an outline to organize the information from the review. Before beginning to write your review, develop an outline based on your synthesis of what you have read using the sections of the

review as major headings in the outline. Depending on the purpose of the written literature review,

you will determine what the major sections of the paper will be. Frequently, a comprehensive liter-

ature review has four major sections: (1) introduction; (2) discussion of theoretical literature; (3)

discussion of empirical literature; and (4) summary. The introduction and summary are standard

sections, but the discussion of sources should be organized by the main ideas that you have identified

or the concepts of the theoretical framework you will use in the study. Under the major headings of

the outline, make notes about which sources you want to mention in the different sections of the

paper.Theintroductionwill includethefocusorpurposeofthereviewandpresenttheorganizational

structure of the review. In this section, you should make clear what you will and will not be covering.

183CHAPTER 6 Literature Review

The discussion section may be divided into theoretical and empirical subsections or divided by

the themes of the review findings. A theoretical literature section might include concept analyses,

models, theories, or conceptual frameworks relevant to the topic. The empirical section, if it is a

separate section, will include the research findings of the articles reviewed. In addition to the syn-

thesis, you want to incorporate the strengths and weaknesses of the overall body of knowledge,

rather than a detailed presentation and critical appraisal of each study. In the summary section

of the outline, make notes of your conclusions. A conclusion is a statement about the state of

knowledge in relation to the topic area.

Write each section of the review. Start each paragraph with a theme sentence that describes the main idea of the paragraph. Present the relevant studies in each paragraph that support the main

idea stated in the theme sentence. End each paragraph with a concluding sentence that transitions

to the next claim. Each paragraph can be compared to a train with an engine (theme sentence),

freight cars connected to each other (sentences with evidence), and a caboose (summary sentence

linking to next paragraph).

Avoid using direct quotes from an author. Your analysis and synthesis of the sources will allow

you to paraphrase the authors’ ideas. Paraphrasing involves expressing the ideas clearly and in

your own words. The meanings of these sources are then connected to the proposed study. If

the written review is not clear or cohesive, you may need to look at your notes and sources again

to ensure that you have synthesized the literature adequately. The defects of a study or body of

knowledge need to be described, but maintain a respectful tone and avoid being highly critical

of other researchers’ work.

As you near the end of the review, write the summary as a concise presentation of the current

knowledge base for the research problem. The findings from the studies will have been logically

presented in the previous sections so that the reader can see how the body of knowledge in the

research area evolved. You will make conclusions about the gaps in the knowledge base. You

may also conclude with the potential contribution of the proposed study to the body of knowledge.

Create the reference list. Many journals and academic institutions use the format developed by the APA (2010). The sixth edition of the APA Publication Manual (2010) provides revised guide-

lines for citing electronic sources and direct quotations from electronic sources and for creating the

reference list. The APA standard for direct quotations from a print source is to cite the page of the

source on which the quotation appears. The reference lists in this text are presented in APA format,

with the exception that we have not included digital object identifiers (DOIs). Digital object iden-

tifiers (DOIs) have become standard for the International Standards Organization (http://www.

doi.org), but have not yet received universal support. The use of DOIs seems to be gaining in cred-

ibility because the DOI “provides a means of persistent identification for managing information on

digital networks” (APA, 2010, p. 188). CrossRef is a registration agency for DOIs so that citations

can be linked across databases and disciplines (http://www.crossref.org).

The sources included in the list of the references are only those that were cited in the paper. Each

citation on an APA-style reference list is formatted as a paragraph with a hanging indent, meaning

that the first line is on the left margin and subsequent lines are indented (see citation examples

below). If you do not know how to format a paragraph this way, search the Help tool in your word

processing program to find the correct command to use. The inclusion of an article published in a

print journal in a reference list includes the journal number, volume, and issue. For most journals,

the numbering of the volumes of the journal represents all the articles published during a specific

year. APA (2010) has requirements for formatting each component of the entry in the reference list

for a journal article. Table 6-7 presents the components of common references with the correct

formatting.

184 CHAPTER 6 Literature Review

An entry on a reference list for a book is listed by the author and includes the publisher and

its location. The University Press, located in Boulder, Colorado, published a revised edition

of Dr. Watson’s philosophy of nursing in 2008. The entry on the reference list would be as follows:

Watson, J. (2008). Nursing. The philosophy and science of caring (Revised ed.). Boulder, CO:

University Press of Colorado.

Some chapters are compiled by editors, with each chapter having its own author(s). The chapter

by Wolf on ethnography is in a qualitative research book edited by Munhall (2012). The chapter

title is formatted like an article title and the page numbers of the chapter are included:

Wolf, M. (2012). Ethnography: The method. In P. L. Munhall (Ed.), Nursing research: A qual-

itative perspective (5th ed.) (pp. 285-338). Sudbury, MA: Jones & Bartlett.

When you retrieve an electronic source in portable document format (pdf), you cite the source

in the same way as if you had made a copy of the print version of the article. When you retrieve an

electronic source in html (hypertext markup language) format, you will not have page numbers for

the citation. Providing the URL (uniform resource locator) that you used to retrieve the article is

not helpful because it is unique to the path you used to find the article and reflects your search

engines and bibliographic databases. The updated APA standard is to provide the URL for the

home page of the journal from which the reader can navigate and find the source.

Check the review and the reference list. You may complete the first draft of your review of the literature and feel a sense of accomplishment. Before you leave the review behind, a few tasks

remain that will ensure the quality of your written review. Begin by rereading the review. It is best

to delay this step for a day or at least a few hours to allow you to take a fresh look at the final written

product. One way to identify awkward sentences or disjointed paragraphs is to read the review

aloud. Ask a fellow student or trusted colleague to read the review and provide constructive

feedback.

A critical final step is to compare the sources cited in the paper to the reference list. Be sure that

the authors’ names and year of publication match. If you are missing sources on the reference list,

add them. If you have sources on the reference list that you did not cite, you can remove them.

Downloading citations from a database directly into a reference management system and using

the system’s manuscript formatting functions reduce some errors but do not eliminate all of them.

You want your references to be accurate as a reflection of your attention to detail and quality of

your work.

TABLE 6-7 AMERICAN PSYCHOLOGICAL ASSOCIATION FORMATTING OF CITATIONS

REFERENCE

COMPONENT TYPE OF FONT CAPITALIZATION EXAMPLE

Article title Regular font • First word of title

and subtitle

• Proper nouns

Nursing students’ fears of failing NCLEX

Grounded theory methods: Similarities and

differences.

Journal title Italicized font • All key words Journal of Clinical Information Systems

Health Promotion Journal

Book title Italicized font • First word of title

and subtitle

• Proper nouns

Qualitative methods: Grounded theory

expanded.

Human resources for health in Uganda.

185CHAPTER 6 Literature Review

K E Y C O N C E P T S

• The review of literature in a research report is a summary of current knowledge about a

particular practice problem and includes what is known and not known about this problem.

• The literature is reviewed to complete an assignment for a course and summarize knowledge for

use in practice.

• Reviews of the literature can be critically appraised for their relevance, comprehensiveness, and

inclusion of current studies.

• A checklist for reviewing the literature includes preparing, conducting the search, processing the

information, and writing the review.

• Electronic databases to be searched are selected based on the types of sources that they include

and the fit of those sources to the purpose of the literature review being conducted.

• The size and efficiency of electronic databases allows for the identification of a large number of

sources quickly.

• Keywords and search terms will allow you to find more relevant references when you search

databases.

• Consult a librarian to help you identify relevant references.

• Reference management software should be used to track the references obtained through the

searches.

• The articles to be included in a review can be further limited by reviewing the abstracts.

• A literature summary table or conceptual map can be used to help you process the information

in numerous studies and identify the main ideas.

• The literature review usually begins with an introduction, includes database sources, and

concludes with a summary of current knowledge.

• Well-written literature reviews are syntheses of what is known and not known.

• Careful checking of the review for grammatical correctness and logical flow are essential to pro-

ducing a quality product.

• The reference list must be accurate and complete to allow readers to retrieve the cited

sources.

REFERENCES

American Nurses Credentialing Center, (2013). Magnet:

Program overview. Silver Springs, MD: Author, a sub-

sidiary of American Nurses Association. Retrieved July

17, 2013 from, http://www.nursecredentialing.org/

Magnet/ProgramOverview.

American Psychological Association (APA), (2010).

Publication manual of the American Psychological

Association (6th ed.). Washington, DC: Author.

Brand, L., Munroe, D., & Gavin, J. (2013). The effect of

hand massage on preoperative anxiety in ambulatory

surgery patients. AORN Journal, 97(6), 708–716.

Corbin, J., & Strauss, A. (2008). Basics of qualitative

research (3rd ed.). Thousand Oaks, CA: Sage.

Creswell, J. (2013). Qualitative inquiry & research design:

Choosing among five approaches (3rd ed.). Thousand

Oaks, CA: Sage.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-basednursing practice.Philadelphia:F.A.Davis.

Garrard, J. (2011). Health sciences literature review made

easy: The matrix method (3rd ed.). Sudbury, MA: Jones

& Bartlett.

Grove, S. K., Burns, N., & Gray, J. (2013). The practice of

nursing research: Conduct, critique, and utilization

(7th ed.). St. Louis: Elsevier Saunders.

Hart, C. (2009). Doing a literature review: Releasing the

social science imagination. Thousand Oaks, CA: Sage.

Kable, A., Pich, J., & Maslin-Prothero, S. (2012). A

structured approach to documenting a search strategy

for publication: A 12-step guideline for authors. Nurse

Education Today, 32(8), 878–886.

Lundy, K. (2012). Historical research. In P. L. Munhall

(Ed.), Nursing research: A qualitative perspective

186 CHAPTER 6 Literature Review

(pp. 381–399). (5th ed.). Sudbury, MA: Jones &

Bartlett.

Luyt, B., Ally, Y., Low, N., & Ismail, N. (2010). Librarian

perception of Wikipedia: Threats or opportunities for

librarianship? Libri, 60(1), 57–64.

Munhall, P. L. (2012). Nursing research: A qualitative

perspective (5th ed.). Sudbury, MA: Jones & Bartlett.

O’Mathuna, D. P., Fineout-Overholt, E., & Jonston, L.

(2011). Critically appraising quantitative evidence for

clinical decision making. In B. M. Melnyk & E. Fineout-

Overholt (Eds.), Evidence-based practice in nursing &

healthcare: A guide to best practice (pp. 81–134). (2nd

ed.). Philadelphia: Lippincott Williams & Wilkins.

Pinch, W. J. (1995). Synthesis: Implementing a complex

process. Nurse Educator, 20(1), 34–40.

Pinch, W. J. (2001). Improving patient care through use of

research. Orthopaedic Nursing, 20(4), 75–81.

Quality and Safety Education for Nurses (QSEN), (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved August 10, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas/.

Trollvik, A., Nordbach, R., Silen, C., & Ringsberg, K. C.

(2011). Children’s experiences of living with asthma:

Fear of exacerbations and being ostracized. Journal of

Pediatric Nursing, 26(4), 295–303.

Vacek, J. E. (2009). Using a conceptual approach with a

concept map of psychosis as an exemplar to promote

critical thinking. Journal of Nursing Education, 48(1),

49–53.

Walls, P., Pahoo, K., & Fleming, P. (2010). The role and

place of knowledge and literature in grounded theory.

Nurse Researcher, 17(4), 8–17.

Watson, J. (2008). Nursing. The philosophy and science of

caring (Revised ed.). Boulder, CO: University Press of

Colorado.

Wolf, M. (2012). Ethnography: The method. In P. L.

Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 285–338). (5th ed). Sudbury, MA:

Jones & Bartlett.

Wuerst, J. (2012). Grounded theory: The method. In P. L.

Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 225–256). (5th ed.). Sudbury, MA:

Jones & Bartlett.

Younger, P. (2010). Using wikis as an online health

information resource. Nursing Standard, 24(36),

49–56.

187CHAPTER 6 Literature Review

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C H A P T E R

7 Understanding Theory and Research

Frameworks

C H A P T E R OV E R V I E W

What Is a Theory?, 190

Understanding the Elements of Theory, 191

Concepts, 191

Relational Statements, 193

Levels of Theoretical Thinking, 194

Grand Nursing Theories, 194

Middle Range and Practice Theories, 195

Study Frameworks, 198

Examples of Critical Appraisal, 199

Framework from a Grand Nursing Theory, 199

Framework Based on Middle Range Theory, 202

Framework from a Tentative Theory, 204

Framework for Physiological Study, 205

Key Concepts, 207

References, 207

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Define theory and the elements of theory

(concepts, relational statements, and

propositions).

2. Distinguish between the levels of theoretical

thinking.

3. Describe the use of middle range theories as

frameworks for studies.

4. Describe the purpose of a study framework.

5. Identify study frameworks developed from

nursing theories.

6. Critically appraise the frameworks in published

studies.

K E Y T E R M S

Abstract, p. 190

Assumptions, p. 191

Concepts, p. 190

Conceptual definition, p. 192

Conceptual models, p. 194

Concrete, p. 190

Constructs, p. 191

Framework, p. 198

Grand nursing theories, p. 194

Implicit framework, p. 198

Maps or models, p. 198

Middle range theories, p. 195

Phenomenon (phenomena),

p. 190

Philosophies, p. 191

Practice theories, p. 197

Propositions, p. 193

Relational statement, p. 193

Scientific theory, p. 198

Specific proposition, p. 193

Statements, p. 190

Substantive theories, p. 196

Tentative theory, p. 198

Theory, p. 190

Variables, p. 191

189

Theories are the ideas and knowledge of science. In a psychology course, you may have studied

theories of the mind, defense mechanisms, and cognitive development that provide explanations

of thinking and behavior. In nursing, we also have theories that provide explanations, but our the-

ories explain human responses to illness and other phenomena important to clinical practice. For

example, nursing has a theory of using music and movement to improve health outcomes

(Murrock & Higgins, 2009). A theory of adaptation to chronic pain (Dunn, 2004, 2005) has also

been developed, as well as a theory of unpleasant symptoms (Lenz, Pugh, Milligan, Gift, & Suppe,

1997). With the increased focus on quality and safety (Sherwood & Barnsteiner, 2012), a theory has

been developed to describe a culture of safety in a hospital (Groves, Meisenbach, & Scott-Cawiezell,

2011). Theories guide nurses in clinical practice and in conducting research.

As a researcher develops a plan for conducting a quantitative study, the theory on which the

study is based is expressed as the framework for the study. A study framework is a brief explanation

of a theory or those portions of a theory that are to be tested in a study. The major ideas of the

study, called concepts, are included in the framework. The framework with the concepts and their

connections to each other may be described in words or in a diagram. When the study is con-

ducted, the researcher can then answer the question, “Was this theory correct in its description

of reality?” Thus a study tests the accuracy of theoretical ideas proposed in the theory. In explaining

the study findings, the researcher will interpret those findings in relation to the theory (Grove,

Burns, & Gray, 2013).

Qualitative studies may be based on a theory or may be designed to create a theory. Because the

assumptions and underlying philosophy of qualitative research (see Chapter 3) are not the same as

quantitative research, the focus of this chapter is on theory as related to quantitative studies. To

assist you in learning about theories and their use in research, the elements of theory are described,

types of theories are identified, and how theories provide frameworks for studies are discussed. You

may notice that references in this chapter are older, because we cited primary sources for the the-

ories, many of which were developed 10 or more years ago. You are also provided with guidelines

for critically appraising study frameworks, and these guidelines are applied to a variety of frame-

works from published studies.

WHAT IS A THEORY?

Scientific professions, such as nursing, use theories to organize their body of knowledge and estab-

lish what is known about a phenomenon. Formally, a theory is defined as a set of concepts and

statements that present a view of a phenomenon. Concepts are terms that abstractly describe and

name an object, idea, experience, or phenomenon, thus providing it with a separate identity or

meaning. Concepts are defined in a particular way to present the ideas relevant to a theory. For

example, Dunn (2004, 2005) developed definitions for the concepts of adaptation and chronic pain

in her theory. The statements in a theory describe how the concepts are connected to each other. A

phenomenon (the plural form is phenomena) is the appearance, objects, and aspects of reality as

we experience them (Rodgers, 2005). You may understand the phenomenon of taking an exam-

ination in a course or the phenomenon of receiving news of your acceptance into nursing school.

As nurses, we intervene in the phenomena of pain, fear, and uncertainty of our patients.

Theories are abstract, rather than concrete. When you hear the term social support, you have an

idea about what the phrase means and how you have observed or experienced social support in

different situations. The concept of social support is abstract, which means that the concept is

the expression of an idea, apart from any specific instance. An abstract idea focuses on a general

view of a phenomenon. Concrete refers to realities or actual instances—it focuses on the

190 CHAPTER 7 Understanding Theory and Research Frameworks

particular, rather than on the general. For example, a concrete instance of social support might be a

time when a friend listened to your frustrations about a difficult clinical situation.

At the abstract level, you may also encounter a philosophy. Philosophies are rational intellectual

explorations of truths or principles of being, knowledge, or conduct. Philosophies describe view-

points on what reality is, how knowledge is developed, and which ethical values and principles

should guide our practice. Other abstract components of philosophies and theories are assump-

tions, which are statements that are taken for granted or considered true, even though they have

not been scientifically tested. For example, a fairly common assumption made by nurses is that

“People want to assume control of their own health problems.” Your clinical experiences may give

you reason to accept or doubt the truth of assumptions. Nonetheless, theorists begin with some

assumptions, explicit or implicit.

UNDERSTANDING THE ELEMENTS OF THEORY

To understand theories, you need to be familiar with their components–concepts and relational

statements. Concepts are the building blocks and relational statements indicate how the concepts

are connected.

Concepts The phenomenon termed social support introduced earlier is a concept. A concept is the basic

element of a theory. Each concept in a theory needs to be defined by the theorist. The definition

of a concept might be detailed and complete, or it might be vague and incomplete and require

further development (Chinn & Kramer, 2011). Theories with clearly identified and defined con-

cepts provide a stronger basis for a study framework.

Two terms closely related to concept are construct and variable. In more abstract theories, con-

cepts have very general meanings and are sometimes referred to as constructs. A construct is a

broader category or idea that may encompass several concepts. For example, a construct for

the concept of social support might be resources. Another concept that is a resource might be

household income. At a more concrete level, terms are referred to as variables and are narrow

in their definition. Thus a variable is more specific than a concept. The word variable implies that

the term is defined so that it is measurable and suggests that numerical values of the term are able

to vary (are variable) from one instance to another. The levels of abstraction of constructs, con-

cepts, and variables are illustrated with an example in Figure 7-1.

A variable related to social support might be emotional support. The researchers might define

emotional support as a study subject’s rating of the extent of emotional encouragement or affir-

mation that he or she receives during a stressful time. The measurement of the variable is a specific

method for assigning numerical values to varying amounts of emotional social support. Subjects

would respond to questions on a survey or questionnaire about emotional support and their indi-

vidual answers would be reported as scores. For example, the Functional Social Support Question-

naire has a three-item subscale that measures perceived emotional support (Broadhead, Gehlbach,

de Gruy, & Kaplan, 1988; Mas-Expósito, Amador-Campos, Gómez-Benito, & Lalucat-Jo, 2011).

One of the items was “People care what happens to me,” and the others addressed whether the

respondent felt loved and received praise for doing a good job (Broadhead et al., 1988, p. 722).

If the Functional Social Support Questionnaire was used by researchers in a study, the subjects’

answers to the three items would be added together as the total score. The subjects’ total scores

on the three questions would be the measurement of the variable of perceived emotional support.

(Chapter 10 provides a detailed discussion of measurement methods.)

191CHAPTER 7 Understanding Theory and Research Frameworks

Defining concepts allows consistency in the way the term is used. Concepts from theories have

conceptual definitions that are developed by the theorist and differ from the dictionary definition

of a word. A conceptual definition is more comprehensive than a denotative (or dictionary) def-

inition and includes associated meanings that the word may have. A conceptual definition is

referred to as connotative, because the term brings to mind memories, moods, or images, subtly

or indirectly. For example, a conceptual definition of home might include feelings of security, love,

and comfort, which often are associated with a home, whereas the dictionary definition is narrower

and more specific—home is a dwelling in which a group of people who may or may not be related

live. Some of the words or terms that are used frequently in nursing language have not been clearly

defined. Terms used in theory or research need connotative meanings based on professional liter-

ature. Connotative definitions are clear statements of the concepts’ meaning in the particular the-

ory or study.

The conceptual definition that a researcher identifies or develops for a concept comes from a

theory and provides a basis for the operational definition. Remember that in quantitative studies,

each variable is ideally associated with a concept, conceptual definition, and operational definition.

The operational definition is how the concept can be manipulated, such as an intervention or inde-

pendent variable, or measured, such as a dependent or outcome variable (see Chapter 5). Concep-

tual definitions may be explicit or implicit. It is important that you identify the researcher’s

conceptual definitions of study variables when you critically appraise a study. Nichols, Rice,

and Howell (2011) conducted a study with 73 overweight children who were 9 to 11 years old

to examine the relationships among anger, stress, and blood pressure. Although the researchers

did not identify the conceptual definitions in the report of the study, the definitions can be

extracted from the study’s framework. The implicit conceptual definition and operational defini-

tion for one concept in the study, trait anger, are presented in Table 7-1. Conceptual and opera-

tional definitions of variables are described in detail in Chapter 5.

Construct

Concept

Variable

Abstract

Concrete

Resources

Social Support

Perceived Family Social Support

FIG 7-1 Link of Theoretical Elements—Construct, Concept, and Variable.

192 CHAPTER 7 Understanding Theory and Research Frameworks

Relational Statements A relational statement clarifies the type of relationship that exists between or among concepts. For

example, in the study just mentioned, Nichols and colleagues (2011) proposed that high levels of

trait anger were related to high blood pressure in overweight children. They also proposed that

high blood pressure was influenced by patterns of anger expression and stress. In regard to the

effects of stress on blood pressure, they provided more detail about how stress affected blood pres-

sure by describing the relationships among the corticotropin-releasing factor, stress response, rate

and stroke volume of the heart, cardiac output, and constriction of the blood vessels that result in

changes in blood pressure. The statements of the physiological processes explaining the connec-

tions between stress and blood pressure were also relational statements. Figure 7-2 is the diagram

that the researchers provided to display the relationships of their framework.

The relational statements are what are tested through research. The researcher obtains data for the

variables that represent the concepts in the study’s framework and analyzes the data for possible sig-

nificant relationships among the variables using specific statistical tests. Testing a theory involves

determining the truth of each relational statement in the theory. As more researchers provide

evidence about the relationships among concepts, the accuracy or inaccuracy of the relational state-

ments is determined. Many studies are required to validate all the relational statements in a theory.

In theories, propositions (relational statements) can be expressed at various levels of abstrac-

tion. Theories that are more abstract (grand nursing theories) contain relational statements that

are called general propositions (Grove et al., 2013). Stating a relationship in a more narrow way

makes the statement more concrete and testable and results in a specific proposition. Specific

propositions in less abstract frameworks (middle range theories) may lead to hypotheses. Hypoth-

eses are developed based on propositions from a grand or middle range theory that comprise the

TABLE 7-1 CONCEPTUAL AND OPERATIONAL DEFINITIONS FOR TRAIT ANGER IN THE STUDY OF OVERWEIGHT CHILDREN

CONCEPT VARIABLE CONCEPTUAL DEFINITION OPERATIONAL DEFINITION

Anger Trait anger Enduring personality characteristic

reflected in the fury, rage, and

displeasure experienced over time

(Nichols, Rice, & Howell, 2011)

Trait anger subscale of the Jacobs

Pediatric Trait Anger Scale (PPS-2;

Jacobs & Blumer, 1984; Nichols et al.,

2011, p. 449)

Adapted from Jacobs, G. & Blumer, C. (1984). The Pediatric Anger Scale. Vermillion, SD: University of South Dakota,

Department of Psychology; and from Nichols, Rice, & Howell, 2011.

Patterns of Anger Expression 1) Anger-Suppression 2) Anger-Out 3) Anger-Reflection/Control

Trait anger

Blood pressure

Stress

FIG 7-2 Framework of Trait Anger, Patterns of Anger Expression, Stress, and Blood Pressure. (From Nichols, K. H., Rice, M., & Howell, C. [2011]. Anger, stress, and blood pressure in overweight children. Journal of Pediatric Nursing, 26[5], 448.)

193CHAPTER 7 Understanding Theory and Research Frameworks

study’s framework. Hypotheses, written at a lower level of abstraction, are developed to be tested in

a study. Statements at varying levels of abstraction that express relationships between or among the

same conceptual ideas can be arranged in hierarchical form, from general to specific. Table 7-2

provides three examples of relationships between two concepts that are written as general prop-

ositions, specific propositions, and hypotheses. The first general proposition includes the con-

structs of enduring personality traits and physiological responses and could be applied to

enduring personality traits, such as determination or self-confidence. In this case, the specific

proposition indicates that the enduring personality trait is trait anger and the physiological

response is blood pressure. The hypothesis proposes a specific relationship between trait anger

and blood pressure that was tested in the study (Nichols et al., 2011).

LEVELS OF THEORETICAL THINKING

Theories can be abstract and broad, or they can be more concrete and specific. Between abstract

and concrete, there are several levels of theoretical thinking. Understanding the degree of abstrac-

tion or level of theoretical thinking will help you to determine whether a theory is applicable to

your research problem.

Grand Nursing Theories Early nurse scholars labeled the most abstract theories as conceptual models or conceptual frame-

works. For example, Roy (Roy & Andrews, 2008) described adaptation as the primary phenomenon

of interest to nursing in her model. This model identifies the elements considered essential to adap-

tation and describes how the elements interact to produce adaptation and thus health. In contrast,

Orem (Orem & Taylor, 2011) presents her descriptions of health phenomena in terms of self-care,

self-care deficits, and nursing systems. Both these theories have been called conceptual models.

What can be confusing is that other scholars do not label Roy’s and Orem’s writings as concep-

tual models, but classify them as grand nursing theories (Peterson & Bredow, 2009). Because of

TABLE 7-2 EXAMPLES OF LOGICAL LINKS* IN A STUDY OF TRAIT ANGER, PATTERNS OF ANGER EXPRESSION, STRESS, AND BLOOD PRESSURE IN OVERWEIGHT CHILDREN

GENERAL PROPOSITION

SPECIFIC

PROPOSITION HYPOTHESIS

Enduring personality traits are

associated with physiological

responses to the environment.

Trait anger is associated

with blood pressure.

Among overweight children, high levels of

trait anger are associated with high

systolic and diastolic blood pressures.

Patterns of emotional responses are

associated with physiological

responses to the environment.

Patterns of anger

expression are

associated with blood

pressure.

Among overweight children, anger

expressed outwardly is associated with

high systolic and diastolic blood

pressures.

Emotional stress is associated with

physiological responses to the

environment.

Stressful events are

associated with blood

pressure.

Among overweight children, high levels of

perceived daily stress are associated with

high systolic and diastolic blood

pressures.

*Between relational statements from abstract to concrete.

From Nichols, K. H., Rice, M., & Howell, C. (2011). Anger, stress, and blood pressure in overweight children. Journal of

Pediatric Nursing, 26(5), 446-455.

194 CHAPTER 7 Understanding Theory and Research Frameworks

this lack of agreement, we will use the term grand nursing theories in this book to describe the nurs-

ing theories that are more abstract. We will reserve the term model to refer to a diagram that graph-

ically presents the concepts and relationships of a framework being used to guide a study. Table 7-3

lists several well-known grand nursing theories, with a brief explanation.

Building a body of knowledge related to a particular grand nursing theory requires an organized

program of research and a group of scholars. The Roy Adaptation Model (RAM) has been used as

the basis for studies for over 25 years. The Roy Adaptation Association is a group of researchers

who “analyze, critique, and synthesize all published studies in English based on the RAM”

(Roy, 2011, p. 312). The Society of Rogerian Scholars continues to conduct studies and develop

knowledge related to Martha Rogers’ Science of Unitary Human Beings (http://www.

societyofrogerianscholars.org/index.html). The International Orem Society publishes a journal,

Self-Care, Dependent-Care, & Nursing, to disseminate research and clinical applications of

Dorothea Orem’s theory of self-care. These are examples of researchers who maintain a network

to communicate with each other and other nurses about their work with a specific theoretical

approach.

Middle Range and Practice Theories Middle range theories are less abstract and narrower in scope than grand nursing theories. These

types of theories specify factors such as a patient’s health condition, family situation, and nursing

actions and focus on answering particular practice questions (Alligood & Tomey, 2010). Middle

range theories are more closely linked to clinical practice and research than grand nursing theories

and therefore have a greater appeal to nurse clinicians and researchers. They may emerge from a

grounded theory study, be deduced from a grand nursing theory, or created through a synthesis

of theories on a particular topic. Middle range theories also can be used as the framework for a study,

thus contributing to the validation of the middle range theory (Peterson & Bredow, 2009). Table 7-4

lists some of the middle range theories currently being used as frameworks in nursing studies. These

published middle range theories have clearly identified concepts, definitions of concepts, and

TABLE 7-3 SELECTED GRAND NURSING THEORIES

NAME

AUTHOR

(YEAR) BRIEF DESCRIPTION

Adaptation Model Roy & Andrews

(2008)

In response to focal, contextual, and residual stimuli, people adapt

by using a variety of processes and systems, some of which are

automatic and some of which are learned. The overall goal is to

return to homeostasis and promote growth.

Self-Care Deficit

Theory of Nursing

Orem (2001) Individuals’ ability to care for themselves is affected by

developmental stage, presence of disease, and available

resources and may result in a self-care deficit. The goal of nursing

is to provide care in proportion to the person’s self-care capacity.

Systems Model Neuman &

Fawcett

(2002)

Stressors can pose a threat to the core processes of the individual.

The core is protected by concentric circles of resistance and

defense.

Theory of Caring Watson (1985) Human caring is a central process of life that influences health.

A nurse may create caring moments with a patient by being an

authentic human and acknowledging the uniqueness of the

patient.

195CHAPTER 7 Understanding Theory and Research Frameworks

relational statements and are referred to as substantive theories. These theories are labeled as sub-

stantive because they are closer to the substance of clinical practice. For example, clinical practice

involves nursing actions to help the patient be comfortable. Kolcaba and Kolcaba (1991) analyzed

the concept of comfort. They defined comfort as the state of relief, ease, and transcendence that is

experienced in the physical, psychospiritual, environmental, and social contexts of a person. From

that concept analysis, a middle range theory of comfort was developed that is applicable to practice

and research. “According to the theory, enhanced comfort strengthens recipients. . ..to engage in activities necessary to achieving health and remaining healthy” (Kolcaba & DiMarco, 2005, p.189).

The theory of comfort has three major constructs (Kolcaba, 1994, 2001) in addition to comfort.

Comfort is “a dynamic state, subject to positive or negative change very quickly” (Kolcaba &

Wilson, 2002). Comfort encompasses relief, ease, and transcendence. Relief is experienced when

pain, nausea, anxiety, or other unsettling experiences are mitigated. Ease occurs when the person is

not having a stressful or painful experience. Transcendence occurs when a person rises above his or

her difficulties or learns to live in a less than desirable situation. When these three components are

present, the person is stronger and able to initiate health-seeking behaviors. Health-seeking behav-

iors may be internal behaviors such as healing or external behaviors such as exercising. A peaceful

death is seen as a normal, health-seeking behavior for persons in the later stages of life. The rela-

tionship of nursing interventions to patient comfort is often altered by intervening variables, such

as the number of nurses available to provide care to hospitalized patients. Note in Figure 7-3, in the

TABLE 7-4 MIDDLE RANGE THEORIES

THEORY RELEVANT THEORETICAL SOURCES

Acute pain Good, 1998; Good & Moore, 1996

Acute pain management Huth & Moore, 1998

Adaptation to chronic pain Dunn, 2004, 2005

Adapting to diabetes mellitus Whittemore & Roy, 2002

Adolescent vulnerability to risk behaviors Cazzell, 2008

Caregiver stress Tsai, 2003

Caring Swanson, 1991

Chronic pain Tsai, Tak, Moore, & Palencia, 2003

Chronic sorrow Eakes, Burke, & Hainsworth, 1998

Client Expression Model Holland, Gray, & Pierce, 2011

Crisis emergencies for individuals with severe,

persistent mental illnesses

Brennaman (2012)

Comfort Kolcaba, 1994

Culturing brokering Jezewski, 1995

Health promotion Pender, Murdaugh, & Parsons, 2006

Home care Smith, Pace, Kochinda, Kleinbeck, Koehler, &

Popkess-Vawter, 2002

Nursing intellectual capital Covell, 2008

Peaceful end of life Ruland & Moore, 1998

Postpartum weight management Ryan, Weiss, Traxel, & Brondino, 2011

Resilience Polk, 1997

Self-care management for vulnerable populations Dorsey & Murdaugh, 2003

Uncertainty in illness Mishel, 1988, 1990

Unpleasant symptoms Lenz, Pugh, Milligan, Gift, & Suppe, 1997

Urine control theory Jirovec, Jenkins, Isenberg, & Baiardi, 1999

196 CHAPTER 7 Understanding Theory and Research Frameworks

top row of the model, that the arrows between the concepts indicate two-way relationships. Patient

comfort is near the middle of the top row and can lead to health-seeking behaviors (HSB). The

institution can influence health-seeking behaviors and health-seeking behaviors can influence

the integrity of the institutional (two-way arrow). The second row of Figure 7-3 has less abstract

concepts that can be manipulated, observed, or measured in a specific study or practice setting.

Comfort care theory has also been applied in a similar way to perianesthesia nursing (Kolcaba

& Wilson, 2002) and pediatric nursing (Kolcaba & DiMarco, 2005).

Practice theories are a type of middle range theories that are more specific. They are designed to

propose specific approaches to particular nursing practice situations. Some scholars call them

situation-specific theories. Brennaman (2012) proposed a situation-specific theory by applying

the middle range theory of crisis for individuals with severe, persistent mental illnesses (ISPMIs;

Ball, Links, Strike, & Boydell, 2005) to care provided in emergency departments. From the perspec-

tive of the individual with SPMI, Ball and associates (2005) described a crisis as feeling over-

whelmed or out of control. In the midst of the crisis, the individual decides whether to

manage alone or seek care. Brennaman extended the middle range theory by identifying that a

subset of crises was mental health emergencies that posed a risk of imminent suicide or harm

to others. When ISPMIs seek help in a crisis, the health provider in the emergency department

must first assess the extent of potential risk and determine whether a mental health emergency

exists. In the presence of a mental health emergency, the provider must immediately intervene

to prevent harm. In situations in which the crisis has not progressed to an emergency, the provider

can refer the person to a mental health specialist. The ideal outcome is a resolution to the crisis. As

seen in this example, applying a middle range theory to a specific situation identifies appropriate

nursing actions. For this reason, practice theories are sometimes referred to as prescriptive theo-

ries. Evidence-based practice guidelines are a good source for practice and prescriptive theories

(see Chapter 13).

Health care

needs

Specific comfort needs

arising in health care situations

Commitment to comfort

care

Staffing levels

Incentives Pt. acuity

Questionnaire from

taxonomic structure

Internal External Peaceful

death

Positive value system

Intentional goals pertaining to

recipients’ comfort, restored health financial viability

Comfort care survey

Functional status or

other HSB

Recipient satisfaction

Nursing interventions

Intervening variables

Patient comfort

Health seeking

behaviors of patient

Institutional integrity

FIG 7-3 Conceptual Framework for Comfort Care Adapted for Outcomes Research. (From Kolcaba, K. [2001]. Evolution of the midrange theory of comfort for outcomes research. Nursing Outlook, 49[2], 9.)

197CHAPTER 7 Understanding Theory and Research Frameworks

Study Frameworks A framework is an abstract, logical structure of meaning, such as a portion of a theory, which

guides the development of the study and enables the researcher to link the findings to nursing’s

body of knowledge. Every quantitative study has an implicit or explicit framework. This is true

whether the study has a physiological, psychological, social, or cultural focus. A clearly expressed

framework is one indication of a well-developed quantitative study. Perhaps the researcher expects

one variable to cause a change in another variable, such as the independent variable of an aerobic

exercise program affecting the dependent variable of weight loss. In a well-developed quantitative

study, the researcher explains abstractly in the framework why one variable is expected to influence

the other. The idea is expressed concretely as a hypothesis to be tested through the study

methodology.

One strategy for expressing a theory or framework is a diagram with the concepts and relation-

ships graphically displayed. These diagrams are sometimes called maps or models (Grove et al.,

2013). For clarity, we are using the term research framework to refer to the concepts and relation-

ships being addressed in a study. The researcher develops or applies the framework to explain the

concepts contributing to or partially causing an outcome. The researcher cites articles and books in

support of the explanation. The model is the diagram used to display the concepts and relation-

ships that allows the reader to grasp of the “wholeness” of a phenomenon.

A model includes all the major concepts in a research framework. Arrows between the concepts

indicate the proposed linkages between them. Each linkage shown by an arrow is a graphic illus-

tration of a relational statement (proposition) of the theory. Nichols and co-workers (2011)

included a diagram of their conceptual framework (see Figure 7-2). In the diagram, the arrows

between trait anger, patterns of anger expression, stress, and blood pressure represent the potential

relationships among these concepts.

Unfortunately, in some quantitative studies, the ideas that compose the framework remain neb-

ulous and are vaguely expressed. Although the researcher believes that the variables being studied

are related in some fashion, this notion is expressed only in concrete terms. The researcher may

make little attempt to explain why the variables are thought to be related. However, the rudiment

of a framework is the expectation (perhaps not directly expressed) that one or more variables are

linked to other variables. Sometimes basic ideas for the framework are expressed in the introduc-

tion or literature review, in which linkages among variables found in previous studies are dis-

cussed, but then the researcher stops, without fully developing the ideas as a framework. These

are referred to as implicit frameworks. In most cases, a careful reader can extract an implicit

framework from the text of the research report. When researchers do not clearly describe the

framework, you may want to draw a model based on the information provided. Having a model

helps you visualize the framework and how the variables are linked. Implicit frameworks provide

limited guidance for the development and conduct of a study and limit the contribution of study

findings to nursing knowledge.

Research frameworks can come from grand nursing theories, middle range theories from nurs-

ing and other professions, syntheses of concepts and relationships from more than one theory, or

syntheses of research findings. In some quantitative studies, the framework that is newly proposed

can be called tentative theory. Syntheses of concepts and relationships from more than one theory

or syntheses of research findings are also examples of tentative theories that are usually developed

for a particular study.

Frameworks for physiological studies are usually derived from physiology, genetics, pathophys-

iology, and physics. This type of theory is called scientific theory. Scientific theory has extensive

evidence to support its claims. Valid and reliable methods exist for measuring each concept and

198 CHAPTER 7 Understanding Theory and Research Frameworks

relational statement in scientific theories. Because the knowledge in these areas has been well

tested through research, the theoretical relationships are often referred to as laws and principles.

In addition, propositions can be developed and tested using these laws and principles and then

applied to nursing problems. However, scientific theories remain open to possible contrary evidence

that would require their revision. For example, prior to this century, scientists believed that they

knew the functions and interactions of various genes. The knowledge gained through the Human

Genome Project (http://www.genome.gov/10001772) has required that scientists revise some of their

theories.

Critically appraising a framework of a quantitative study requires that you go beyond the frame-

work itself to examine its linkages to other components of the study, such as measurement of the

variables and implementation of an intervention, if applicable. Begin by identifying the concepts

and conceptual definitions from the written text in the introduction, literature review, or discus-

sion of the framework. Then you must judge the adequacy of the linkages of concepts to variables,

measurement of research or dependent variables, and implementation of independent variables.

You also need to determine if the study findings have been linked back to the study framework.

Researchers usually link the findings back to the framework and other literature in the discussion

section of the research report.

EXAMPLES OF CRITICAL APPRAISAL

In this section, critical appraisal guidelines are applied to frameworks that were derived from a

grand nursing theory, middle range theory, tentative theory, and/or scientific theory.

Framework from a Grand Nursing Theory One of the challenges with grand nursing theories is their abstractness and difficulty in measuring

their concepts. Some researchers have deduced middle range theories from grand nursing

theories and used middle range theories to guide their studies. Other researchers have used a grand

nursing theory as an overall framework but have not directly linked the variables to the theory

constructs. Other researchers, such as Tao, Ellenbecker, Chen, Zhan, and Dalton (2012), have iden-

tified a proposition from a grand nursing theory and tested hypotheses derived from the

proposition.

? CRITICAL APPRAISAL GUIDELINES Framework of a Study

The quality of a framework in a quantitative study needs to be critically appraised to determine its usefulness for

directing the study and interpreting the study findings. The following questions were developed to assist you in

evaluating the quality of a study’s framework:

1. Is the study framework explicitly expressed in the study?

2. What is the name of the theory and theorist used for the framework?

3. What are the concepts in the framework?

4. Is each study variable or concept conceptually defined in the study?

5. Are the operational definitions of the variables consistent with their associated conceptual definitions?

6. Do the researchers clearly identify the relationship statement(s) or proposition(s) from the framework being

examined by the study design?

7. Are the study findings linked back to the framework?

199CHAPTER 7 Understanding Theory and Research Frameworks

RESEARCH EXAMPLE

Self-Care Deficits

Research Study The Centers for Medicare and Medicaid services (CMS) will no longer pay for the care of Medicare patients who

have been hospitalized for acute myocardial infarction, heart failure, and pneumonia and are admitted again within

30 days of being discharged (CMS, 2013). This makes Tao and colleagues’study highly relevant. The researchers (Tao

et al., 2012) used Orem’s theory of self-care deficits to “examine the relationship of social environmental factors to

home healthcare patients’ rehospitalizations” (p. 346) and stated that their second purpose was to “test a hypothesis

from Orem’s theory” (p. 350). Using a retrospective correlational study, the researchers obtained data without

names and other identifying information from a standardized database, the Outcome and Assessment Information

Set (OASIS). These patients were 65 to 99 years of age and received home health care after being hospitalized. The

researchers proposed that some of the patients had been readmitted to the hospital because of self-care deficits.

Orem proposed that a self-care deficit occurs when people need more care than they can provide for themselves.

Self-care deficit is the difference between a person’s health-related needs and his or her ability to meet these needs.

She also proposed that people have a certain amount of ability and motivation to provide care for themselves and

labeled the concept self-care agency (Orem & Taylor, 2011). Therapeutic self-care demand occurs when the person

must take additional actions because of being acutely or chronically ill. The framework of the study included two

propositions from Orem’s theory:

“Orem’s conceptual model proposes that basic conditional factors (BCFs) and power components (PCs)

affect a patient’s self-care agency. Therapeutic self-care demand (TSCD) and self-care agency are interre-

lated and, when known, can predict a patient’s self-care deficit or ability. . ..Figure 7-4 presents the conceptual

framework that guides this study. The difference between the clinical status score and the functional ability

score (therapeutic self-care demand minus self-care agency) relates to rehospitalization (self-care deficit).

The patient’s functional ability (self-care agency), in turn, is influenced by the patient’s cognitive functioning

and the BCFs of age, gender, risk characteristics, and social environmental factors. The influences of the

social environmental factors are poorly understood and are the focus of this study.” (Tao et al., 2012,

pp. 347-348)

InFigure7-4,thebasicconditionalfactorsaredisplayedinaboxandarelistedasage,gender,highriskcharacteristics,and

societal environmental factors. The social environmental factors specifically being studied are listed; these include living

Clinical status score

Age Gender High-risk characteristics Social environment factors Living arrangement Primary informal caregiver Frequency of informal care Type of informal care

Cognitive functioning

Functional ability score– Re-hospitalization

Therapeutic Self-Care Demand

Basic Conditioning Factors Power Component

Self-Care Agency Self-Care Defecit

FIG 7-4 Framework of Social Environmental Factors Affecting Rehospitalization of Medicare Patients. (From Tao, H., Ellenbecker, C., Chen, J., Zhan, L., & Dalton, J. [2012]. The influence of social environmental factors on hospitalization among patients receiving home health care services. Advances in Nursing Science, 35[4], 346-358.)

200 CHAPTER 7 Understanding Theory and Research Frameworks

arrangement, primary informalcaregiver, frequencyof informal care, and type of informal care. The arrow from the BCFs

box to the functional ability score in the box above represents the relationship from the theory that BCFs affect self-care

agency. Cognitive function was identified as an aspect of the power component, another concept that affects self-care

agency. Therapeutic self-care demand and self-care agency are within a box made of dotted lines to indicate that they

are associated with each other. The researchers provided a table of concepts, variables, and scoring for each variable.

We have summarized the connections among the concepts and variables in Table 7-5.

In the OASIS data set for one home health agency, 1268 patients were identified as being eligible to be included in

the study. The analysis revealed support for the first hypothesis. Patients who were men, had other assistance at

home, lived alone, or received frequent care had high functional ability. Patients who were obese and older patients

were most likely to be rehospitalized. Also, “higher levels of cognitive functioning were related to higher levels of

functional ability” (p. 352). Tao and colleagues (2012) also learned that the greater the difference between clinical

status and functional status, the more likely it was that the patient had been rehospitalized.

“This study supported that social environmental factors contributed to rehospitalization (self-care deficit)

through functional ability (self-care agency) by altering the balance between the self-care demand and

self-care agency.” (Tao et al., 2012, p. 354)

Clinical Appraisal Tao and associates (2012) made strong connections between the theory and the study. First, they clearly identified

the name of the theory and theorists. They explicitly identified the theory’s concepts to be studied and defined them

(see Table 7-5). The operational definitions were consistent with the conceptual definitions of the variables. The

propositions were identified, along with the hypotheses. In the discussion section of the report, the researchers indi-

cated how the findings were consistent with the framework.

“Specifically, the study determined that increasing age, obesity, lower levels of cognitive functioning, and

receiving less care from [an] informal caregiver are related to lower functional ability and may increase

the possibility of rehospitalization.” (Tao et al., 2012, p. 354) Continued

TABLE 7-5 CONSTRUCTS, CONCEPTS, VARIABLES, AND DATA RELATED TO OREM’S SELF-CARE DEFICIT THEORY*

CONSTRUCT CONCEPT VARIABLE

Therapeutic

self-care

demand

Health status Clinical status score¼case mix measure of diagnoses, therapies, presence of pain, pressure ulcers,

incontinence, and behavior problems

Self-care

agency

Functional ability Functional ability score¼case mix measure of activities of daily living such as ability to dress,

bath, toilet, and ambulate

Power

component

Cognitive functioning Cognitive function score¼score on the Cognitive Function Scale

Basic

conditioning

factors

Risk characteristics Total risk factors¼heavy smoking, obesity, alcohol dependency, and drug dependency

Personal characteristics Age, gender, living arrangements

Informal caregiving Presence of informal caregiver, frequency

of caregiving, type of primary informal care

Self-deficit Rehospitalization Readmission within 60 days

Number of days Days between discharge and rehospitalization

*As used by Tao and colleagues in their study of Medicare patients receiving home healthcare: Tao H., Ellenbecker, C.,

Chen, J., Zhan, L., & Dalton, J. (2012). The influence of social environmental factors on hospitalization among patients

receiving home health care services. Advances in Nursing Science, 35(4), 346-358.

201CHAPTER 7 Understanding Theory and Research Frameworks

Framework Based on Middle Range Theory Many frameworks for nursing studies are based on middle range theories. These studies test the

validity of the middle range theory and examine the parameters within which the middle range

theory can be applied. Some nursing researchers have used middle range theories developed by

non-nurses. Other researchers have used middle range theories that they or other nurses have

developed to explain nursing phenomena. In either case, middle range theories should be tested

before being applied to nursing practice.

RESEARCH EXAMPLE—cont’d

Implications for Practice The researchers began the report by noting the need to inform policy makers about the factors contributing to

rehospitalization and to educate home health nurses about the importance of social environmental factors. At

the end of the report, they returned to the implications for policy and practice.

“The results of this study have implications for home health care reimbursement policy strategies for reduc-

ing unnecessary hospitalizations and improving the quality of home health care. Findings may help home

healthcare nurses recognize those patients who are in need of certain services that may reduce rehospita-

lization, such as those that lack the support of the patient’s family or assistance from paid informal caregi-

vers. . .When health problems arise, those with adequate social environmental support are more likely to seek

medical care before the problems become more serious. The importance of social environmental support and

its ability to motivate patients to increased levels of functioning has the potential to reduce rates of rehos-

pitalizations.” (Tao et al., 2012, pp. 355-356)

Before these findings are broadly applied, however, the study needs to be replicated with a nationally representative

sample because this sample was from a single home healthcare agency.

RESEARCH EXAMPLE

Framework based on Middle Range Theory

Research Study Park, Stotts, Douglas, Donesky-Cuenco, and Carrieri-Kohlman (2012) adapted the middle range theory of unpleas-

ant symptoms (Lenz et al., 1997) for their study of symptoms related to asthma and chronic obstructive pulmonary

disease. Their sample was 86 Korean immigrants in outpatient settings. From the theory, they used the theorists’

influencing factors and multiple symptoms and linked them to functional performance to create the framework

for the study (see Figure 7-5, in this example). Functional performance is the outcome concept and is shown on

the right side of the model. Multiple symptoms are connected to functional performance by a one-way arrow, indi-

cating the direction of influence. In other words, the experience of multiple symptoms affects functional perfor-

mance. On the left side of the model, influencing factors has been divided into smaller components.

Physiological factors are identified as age, gender, disease group, duration of the disease, comorbidities, and dyspnea.

Each of the influencing factor boxes has the variables that will be used to measure that concept. There may be addi-

tional relationships among these concepts but those displayed are the relationships being analyzed in the study.

Consistent with the main premise of the theory of unpleasant symptoms, Park and colleagues (2012, p. 227)

assessed symptom clusters of the subjects because “multiple symptoms are experienced simultaneously” and increase

exponentially in their effect as the number of symptoms increases. For example, the experience of having nausea and

dyspnea at the same time is more than adding together the experiences of having each alone. The combination of

experiencing nausea and dyspnea at the same time makes the situation more distressing. The researchers also ana-

lyzed the relationships among symptoms and functional performance. Table 7-6 presents the concepts of the middle

range theory with the operational definitions.

Park and colleagues (2012, p. 233) described the subjects’ symptoms by severity, frequency, persistence, distress,

and burden and found three clusters (groups) of symptoms that when they occurred together, affected

202 CHAPTER 7 Understanding Theory and Research Frameworks

functional status. One cluster was comprised of “age, level of education, working status, level of acculturation, and

mean severity score of 7 symptoms” and explained a significant amount of the variance in functional status. Another

factor was a set of emotional responses, such as feeling sad or nervous, and physiological responses, such as dyspnea.

The third cluster had only two elimination-related symptoms—constipation and urinary problems. The second and

third groups (clusters) of characteristics and symptoms also were found to affect functional status.

Critical Appraisal The researchers provided a model of the study’s framework (see Figure 7-5) and provided the names of the theorists

for the middle range theory from which it was adapted (Lenz et al. 1997). The concepts in the framework were Continued

Physiologic Factors; age, gender, disease group (asthma vs. COPD), duration of disease, comorbidities, and dyspnea

Multiple Symptoms

Functional Performance

Psychologic Factors: mood

Situational Factors; living situation, social support, years in the U.S., and acculturation

Other Sample Characteristics; smoking history, education level, and income level

FIG 7-5 Framework of Symptoms in Chronic Obstructive Pulmonary Disease and Asthma Patients. (Adapted from Park, S. K., Stotts, N., Douglas, M., Donesky-Cuenco, D., & Carrieri-Kohlman, V. [2012]. Symptoms and functional performance in Korean immigrants with asthma or chronic obstructive pulmonary disease. Heart & Lung, 41[3], 226-237.)

TABLE 7-6 CONCEPTUAL AND OPERATIONAL DEFINITIONS FOR THE STUDY OF SYMPTOMS AND FUNCTIONAL PERFORMANCE*

CONCEPT CONCEPTUAL DEFINITION OPERATIONAL DEFINITION

Symptoms “Multidimensional experience that

incorporates intensity, timing, distress,

and quality” (p. 227)

“The Memorial Symptom Assessment

Scale (MSAS) is a self-report

questionnaire designed to measure the

multidimensional experience of

symptoms” (p. 228).

Influencing

factors

“Physiological (pathological problems),

psychological (mood), and situational

(social support)” (p. 227)

“The Profile of Moods States—Short Form

(POMS-SF) was used to measure the

moods of the participants” (p. 229).

Other tools measured the other

influencing factors.

Consequences

of symptoms

Experiencing a symptom affects one’s

performance.

“The Functional Performance Inventory-

Short Form (FPI-SF) was used to elicit

participants’ descriptions of their

functional performance” (p. 229).

*In Korean immigrants with asthma or chronic obstructive pulmonary disease.

From Park, S. K., Stotts, N., Douglas, M., Donesky-Cuenco, D., & Carrieri-Kohlman, V. (2012). Symptoms and functional

performance in Korean immigrants with asthma or chronic obstructive pulmonary disease. Heart & Lung, 41(3), 226-237.

203CHAPTER 7 Understanding Theory and Research Frameworks

Framework from a Tentative Theory Findings from completed studies reported in the literature can be a rich source of frameworks

when synthesized into a coherent, logical set of relationships. The findings from studies, especially

when combined with concepts and relationships from middle range theories or non-nursing the-

ories, can be synthesized into a tentative theory that provides a framework for a particular study.

The study by Nichols and associates (2011) that was used as an example earlier in the chapter will

be described in more detail here and its framework critically appraised.

RESEARCH EXAMPLE—cont’d

identified in the model (see Figure 7-5) and defined in the narrative. The operational definitions for the concepts

were consistent with the conceptual definitions (Table 7-6). The relational statements were clear in the model and

were supported by the study results. However, the researchers did not link the findings to the study’s framework. The

researchers could have done this by discussing the application of the findings to the concepts and relationships of the

framework.

Implications for Practice The researchers indicated nurses should evaluate coexisting symptoms, because “alleviating these symptoms may be

important in improving daily functioning in people with chronic obstructive pulmonary disease” (Park et al., 2012,

p. 235). They recognized that more research is needed prior to developing interventions to alleviate symptoms.

RESEARCH EXAMPLE

Framework from a Tentative Theory

Research Study Nichols and co-workers (2011, p. 447) conducted a study to describe “levels of trait anger, patterns of anger expres-

sion, and stress in overweight and obese 9- to 11-year-old children.” They also compared the influences of these

concepts on the blood pressure of the children. Following the review of literature, the researchers explicitly stated

their framework, as follows:

“Anger, a feeling varying in intensity from mild displeasure to fury or rage (Spielberger, Reheiser, & Sydeman,

1995), can be examined both as the level of trait anger and as the patterns used to express that anger [see

Figure 7-2 earlier in the chapter]. Trait anger is more stable and reflects the extent of the experience of angry

feelings over time (Spielberger et al., 1995). Equally important is the pattern used to express anger, such as

anger-in (holding in anger or denying angry feelings), anger-out (expressing anger openly), or anger reflection-

control (using a cognitive, problem-solving approach to dealing with anger; (Jacobs, Phelps, & Rhors, 1989;

Siegman & Smith, 1994) . . . In addition to anger, stress can have an impact on the physiological functioning of

children through activation of the hypothalamic-pituitary-adrenocortical (HPA) system (McEwen, 2007; Ryan-

Wenger, et al., 2000) and of the sympathetic nervous system (Institute of Medicine, 2001; McEwen,

2007). . .. The body responds by (a) increasing the rate and stroke volume of the heart contraction and thereby

increasing cardiac output and (b) constricting vessels in the blood reservoirs and thus increasing BP

(McEwen, 2007; Severtsen & Copstead, 2000).” (Nichols et al., 2011, pp. 448-449)

Critical Appraisal Nichols and colleagues (2011) clearly described their framework by providing a description and a model of the con-

cepts and relationships (see Figure 7-3). The theory was a synthesis of evidence from published studies, so there was

no theorist identified. The concepts in the model were defined conceptually and operationally. For example, trait

anger was conceptually defined as the “extent of the experience of angry feelings over time (Spielberger et al., 1995)”

(Nichols et al., 2011, p. 448). Nichols and associates provided an operational definition of trait anger that was “mea-

sured by the 10-item trait anger subscale of the Jacobs Pediatric Trait Anger Scale” (PPS-2; Jacobs & Blumer, 1984,

p. 449). The operational definition of each concept was consistent with its conceptual definition. Gender, an

204 CHAPTER 7 Understanding Theory and Research Frameworks

Framework for Physiological Study Developing a physiological framework to express the logic on which the study is based clearly is

helpful to the researcher and readers of the published study. The critical appraisal of a physiological

framework is no different from that of other frameworks. However, concepts and conceptual def-

initions in physiological frameworks may be less abstract than concepts and conceptual definitions

in psychosocial studies. Concepts in physiological studies might be such terms as cardiac output,

dyspnea, wound healing, blood pressure, tissue hypoxia, metabolism, and functional status. For exam-

ple, in mechanically ventilated patients, nurse researchers have described the risk of bacteremia

(concept) after oral care (Jones, Munro, Grap, Kitten, & Edmond, 2010). Among cardiac patients,

they have studied the effects of beta blockers on fatigue (concept) in chronic heart failure (Tang,

Yu, & Yeh, 2010) and compared the inflammatory biomarkers (concept) of persons with coronary

artery disease to those without coronary artery disease (Jha, Divya, Prasad, & Mittal, 2010).

Another example is a study conducted by Corbett, Daniel, Drayton, Field, Steinhardt, and

Garrett (2010) to describe the effects of dietary supplements on anesthesia. In this study, the

researchers wanted to determine the effects of specific physiological processes and therefore needed

high levels of control in the study. To accomplish this without harming human subjects, an animal

study was designed using the scientific theory.

important factor in two of the research questions, was not included in the model and was not defined. The relational

statements were embedded in the review of literature and conceptual framework sections but were not stated as

propositions and no hypotheses were developed for testing in this study. The model did graphically present the

relationships. The study would have been stronger if the propositions expressed in the model were linked to hypoth-

eses that might have been tested in the study. This would have provided clearer links of the concepts and relation-

ships in the model and the variables expressed in the hypotheses. Nichols and co-workers (2011, p.453) linked the

findings back to the framework in the discussion section.

“The conceptual framework as depicted was partially supported by the findings. A significant amount of the

variance in SBP [systolic blood pressure] in the group as a whole was accounted for by trait anger, patterns of

anger expression, and stress. Trait anger was an independent predictor of SBP. However, this set of variables

did not explain a significant amount of the variance in DBP [diastolic blood pressure].”

Implications for Practice Nichols and colleagues (2011, pp. 453-454) stated the study implications for practice in their conclusions and indi-

cated that the relationships among these concepts in overweight children warrants additional research.

“. . .it is important for healthcare providers to assess BP and to consider treatments for such elevations.

Because overweight and obese children are particularly vulnerable to elevations in BP (McNiece et al.,

2007), assessment of BP and weight in school-aged children is critical. . . healthcare providers may also need

to assess trait anger, patterns of anger expression, and stress.”

RESEARCH EXAMPLE

Study Framework from Scientific Theories of Inflammation and Dietary Supplements

Research Study Increasing numbers of people are using herbal and dietary supplements. As certified registered nurse anesthetists,

Corbett and associates (2010) were concerned about the risks of dietary supplements having negative interactions

with anesthesia. They were also interested in the potential positive effects of dietary supplements on inflammation.

They identified ellagic acid that can be extracted from pomegranate juice as the specific substance that they wanted

to test. Continued

205CHAPTER 7 Understanding Theory and Research Frameworks

RESEARCH EXAMPLE—cont’d

“The primary objective of this study was to investigate the anti-inflammatory effects of ellagic acid compared

with known selective and non-selective COX [cyclooxygenase] inhibitors in male Sprague-Dawley rats as

measured by paw volume assessment. The secondary objective investigated [about] whether there is an

interaction between ellagic acid and the anesthesia adjunct ketorolac or the COX-2 inhibitor meloxicam.”

(Corbett et al., 2010, p. 216)

The researchers provided a model with the physiological pathways that resulted in inflammation of the rat paw or

homeostasis after an injection of a noxious substance (see Figure 7-6). In the model, tissue injury affects the phos-

pholipids, which release arachidonic acid. They proposed that ellagic acid interfered with the release of

cyclooxygenase-2 (COX-2), which causes inflammation. The experiment was conducted using six groups that

received different combinations of ellagic acid, ketorolac, meloxicam, and the solution used to inject the substances

into the rats. At 4 and 8 hours after injection of the noxious substance, edema was reduced in the paws into which

ellagic acid was also injected.

Critical Appraisal Corbett and co-workers (2010) developed the study framework from scientific theories of inflammation and dietary

supplements. They provided a model, which would have been clearer had it included ellagic acid as a concept. COX-

1 and COX-2 were defined in the caption for the figure, but are not clearly described in the text of the paper. The

extent of inflammation was operationalized as paw edema, with a detailed procedure for obtaining the measure-

ment. The relationships among the concepts were displayed in the model as nondirection connections between

the concepts and were not stated as propositions. The study findings were not linked back to the framework.

The findings were congruent with the findings of other studies and supported the framework in that ellagic acid

decreased inflammation (edema). Although not directly tested, ellagic acid appears to decrease the effects of

COX-2, which in turn decreases inflammation.

Implications for Practice Corbett and colleagues (2010, p. 219) stated the following implications for practice:

“Clearly, the rise in the use of dietary supplements, specifically ellagic acid, poses both potential risks and

benefits during the perianesthesia period and should be carefully evaluated and considered by the anesthesia

provider during patient assessment.”

Additional laboratory and animal studies are needed to confirm the findings and determine the mechanisms

whereby ellagic acid interferes with inflammation. Another approach would be to conduct a retrospective study

of surgery patients to describe their responses to anesthesia in relation to their use of dietary supplements.

Tissue Injury

Membrane Phospholipids

Arachidonic Acid

Cyclooxygenase 2 Cyclooxygenase 1

HomeostasisInflammation

FIG 7-6 Framework of Ellagic Acid and Anti-Inflammation Effects. (From Corbett, S., Daniel, J., Drayton, R., Field, M., Steinhardt, R., & Garrett, N. [2010]. Evaluation of the anti-inflammatory effects of ellagic acid. Journal of PeriAnesthesia, 25[4], 216.)

206 CHAPTER 7 Understanding Theory and Research Frameworks

K E Y C O N C E P T S

• Theory is essential to research because it is the initial inspiration for developing a study and

links the study findings back to the knowledge of the discipline.

• A theory is an integrated set of concepts, definitions, and statements that presents a view of a

phenomenon.

• The elements of theories are concepts and relational statements.

• Conceptual models or grand nursing theories are very abstract and broadly explain phenomena

of interest.

• Middle range and tentative theories are less abstract and narrower in scope than conceptual

models.

• Every study has a framework, although some frameworks are poorly expressed or are implicit.

• A framework is an abstract, logical structure of meaning, such as a portion of a theory, that

guides the development of the study, is tested in the study, and enables the researcher to link

the findings to nursing’s body of knowledge.

• To be used appropriately, the study framework must include the concepts and their definitions.

The relational statements or propositions being examined need to be clear and represented by a

model or map.

• Frameworks for studies may come from grand nursing theories, middle range theories, research

findings, non-nursing theories, tentative theories, and scientific theories.

• Scientific theories are derived from physiology, genetics, pathophysiology, and physics and are

supported by extensive evidence.

• Critically appraising a framework requires the identification and evaluation of the concepts,

their definitions, and the statements linking the concepts. Then the study findings are examined

in the context of the framework to determine the usefulness of the framework in describing

reality.

REFERENCES

Alligood, M. R., & Tomey, A. M. (2010). Nursing theorists

and their work (7th ed.). Maryland Heights, MO:

Mosby Elsevier.

Ball, J. S., Links, P. S., Strike, C., & Boydell, K. M. (2005).

It’s overwhelming. . .everything seems to be too much: A theory of crisis for individuals with severe persistent

mental illness. Psychiatric Rehabilitation Journal, 29(1),

10–17.

Brennaman, L. (2012). Crisis emergencies for individuals

with severe, persistent mental illnesses: A situation-

specific theory. Archives of Psychiatric Nursing, 26(4),

251–260.

Broadhead, W. E., Gehlbach, S. H., de Gruy, F., & Kaplan, B.

H. (1988). The Duke-UNC Functional Social Support

Questionnaire: Measurement of social support in family

medicine patients. Medical Care, 26(7), 709–723.

Cazzell, M. (2008). Linking theory, evidence, and practice

in assessment of adolescent inhalant use. Journal of

Addictions Nursing, 19(1), 17–25.

Centers for Medicare and Medicaid Services, (2013).

Readmission reduction program. Retrieved July 1, 2013

from, http://www.cms.gov/Medicare/Medicare-Fee-

for-Service-Payment/AcuteInpatientPPS/

Readmissions-Reduction-Program.html.

Chinn, P. L., & Kramer, M. K. (2011). Integrated theory and

knowledge development in nursing (8th ed.). St. Louis:

Elsevier Mosby.

Corbett, S., Daniel, J., Drayton, R., Field, M.,

Steinhardt, R., & Garrett, N. (2010). Evaluation of the

anti-inflammatory effects of ellagic acid. Journal of

PeriAnesthesia Nursing, 25(4), 214–220.

Covell, C. L. (2008). The middle-range theory of nursing

intellectual capital. Journal of Advanced Nursing, 63(1),

94–103.

Dorsey, C. J., & Murdaugh, C. L. (2003). The theory of

self-care management for vulnerable populations.

Journal of Theory Construction & Testing, 7(2),

43–49.

207CHAPTER 7 Understanding Theory and Research Frameworks

Dunn, K. S. (2004). Toward a middle-range theory of

adaptation to chronic pain. Nursing Science Quarterly,

17(1), 78–84.

Dunn, K. S. (2005). Testing a middle-range theoretical

model of adaptation to chronic pain. Nursing Science

Quarterly, 18(2), 146–156.

Eakes, G. G., Burke, M. L., & Hainsworth, M. A. (1998).

Middle-range theory of chronic sorrow. Journal of

Nursing Scholarship, 30(2), 179–184.

Good, M. A. (1998). A middle range theory of acute pain

management: Use in research. Nursing Outlook, 46(3),

120–124.

Good, M., & Moore, S. M. (1996). Clinical practice

guidelines as a new source of middle range theory:

Focus on acute pain. Nursing Outlook, 44(2), 74–79.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis: Elsevier Saunders.

Groves, P., Meisenbach, R., & Scott-Cawiezell, J. (2011).

Keeping patients safe in healthcare organizations: A

structuration theory of safety culture. Journal of

Advanced Nursing, 67(8), 1846–1855.

Holland, B., Gray, J., & Pierce, T. (2011). The client

experience model: Synthesis and application to African

Americans with multiple sclerosis. Journal of Theory

Construction & Testing, 15(2), 36–40.

Huth, M. M., & Moore, S. M. (1998). Prescriptive

theory of acute pain management in infants and

children. Journal of the Society of Pediatric Nurses, 3(1),

23–32.

Institute of Medicine, (2001). Health and behavior: The

interplay of biological, behavioral, and societal

influences. Washington, DC: National Academy of

Science.

Jacobs, G., & Blumer, C. (1984). The Pediatric Anger Scale.

Vermillion, SD: University of South Dakota, Depart-

ment of Psychology.

Jacobs, G., Phelps, M., & Rhors, B. (1989). Assessment of

anger in children: The Pediatric Anger Expression

Scale. Personality and Individual Differences, 10(1),

59–65.

Jezewski, M. A. (1995). Evolution of a grounded theory:

Conflict resolution through culture brokering.

Advances in Nursing Science, 17(3), 14–30.

Jha, H., Divya, A., Prasad, J., & Mittal, A. (2010). Plasma

circulatory markers in male and female patients with

coronary artery disease. Heart & Lung, 39(4), 296–303.

Jirovec, M. M., Jenkins, J., Isenberg, M., & Baiardi, J.

(1999). Urine control theory derived from Roy’s

conceptual framework. Nursing Science Quarterly, 12

(3), 251–255.

Jones, D., Munro, C., Grap, M. J., Kitten, T., &

Edmond, M. (2010). Oral care and bacteremia risk in

mechanically ventilated adults. Heart & Lung, 39(6S),

S57–S65.

Kolcaba, K. (1994). A theory of comfort for nursing.

Journal of Advanced Nursing, 19(6), 1178–1184.

Kolcaba, K. (2001). Evolution of the mid range theory of

comfort for outcomes research. Nursing Outlook, 49(2),

86–92.

Kolcaba, K., & DiMarco, M. (2005). Comfort theory and

its application to pediatric nursing. Pediatric Nursing,

31(3), 187–194.

Kolcaba, K., & Kolcaba, R. (1991). An analysis of the

concept of comfort. Journal of Advanced Nursing, 16

(11), 1301–1310.

Kolcaba, K., & Wilson, L. (2002). Comfort care: A

framework for perianesthesia nursing. Journal of

PeriAnesthesia Nursing, 17(2), 102–114.

Lenz, E. R., Pugh, L. C., Milligan, R., Gift, A., & Suppe, F.

(1997). The middle range theory of unpleasant

symptoms: An update. Advances in Nursing Science, 19

(3), 14–27.

Mas-Expósito, L., Amador-Campos, J., Gómez-Benito, J.,

& Lalucat-Jo, L. Research Group on Severe Mental

Disorder. (2011). The World Health Organization

Quality of Life Scale Brief Version: Avalidation study in

patients with schizophrenia. Quality of Life Research, 20

(7), 1079–1089.

McEwen, B. (2007). Physiology and neurobiology of stress

and adaptation. Physiological Reviews, 87(3), 873–904.

McNiece, K., Poffenbarger, T., Turner, J., Franco, F.,

Sorof, J., & Portman, R. (2007). Prevalence of

hypertensions and pre-hypertension among

adolescents. Journal of Pediatrics, 150(6), 640–644.

Mishel, M. H. (1988). Uncertainty in illness. Journal of

Nursing Scholarship, 20(4), 225–232.

Mishel, M. H. (1990). Reconceptualization of the

uncertainty in illness theory. Journal of Nursing

Scholarship, 22(3), 256–262.

Murrock, C., & Higgins, P. (2009). The theory of music,

mood, and movement to improve health outcomes.

Journal of Advanced Nursing, 65(10), 2249–2257.

Neuman, B., & Fawcett, J. (2002). The Neuman systems

model (4th ed.). Upper Saddle River, NJ: Prentice-Hall.

Nichols, K. H., Rice, M., & Howell, C. (2011). Anger, stress,

and blood pressure in overweight children. Journal of

Pediatric Nursing, 26(5), 446–455.

Orem, D. E. (2001). Nursing: Concepts of practice (6th ed.).

St. Louis: Mosby.

Orem, D. E., & Taylor, S. G. (2011). Reflections on nursing

practice science: The nature, the structure, and the

208 CHAPTER 7 Understanding Theory and Research Frameworks

foundation of nursing science. Nursing Science

Quarterly, 24(1), 35–41.

Park, S. K., Stotts, N., Douglas, M., Donesky-Cuenco, D.,

& Carrieri-Kohlman, V. (2012). Symptoms and

functional performance in Korean immigrants with

asthma or chronic obstructive pulmonary disease.

Heart & Lung, 41(3), 226–237.

Pender, N. J., Murdaugh, C. L., & Parsons, M. A. (2006).

Health promotion in nursing practice (5th ed.). Upper

Saddle River, NJ: Pearson & Prentice Hall.

Peterson, S. J., & Bredow, T. S. (2004). Middle range

theories: Application to nursing research. Philadelphia:

Lippincott Williams & Wilkins.

Polk, L. V. (1997). Toward a middle-range theory of

resilience. Advances in Nursing Science, 19(3), 1–13.

Rodgers, B. (2005). Developing nursing knowledge:

Philosophical traditions and influences. Philadelphia:

Lippincott Williams & Wilkins.

Roy, C. (2011). Research based on the Roy Adaptation

Model: Last 25 years. Nursing Science Quarterly, 24(4),

312–320.

Roy, C., & Andrews, H. A. (2008). Roy Adaptation Model

(3rd ed.). Upper Saddle River, NJ: Prentice Hall Health.

Ruland, C. M., & Moore, S. M. (1998). Theory construction

based on standards of care: A proposed theory of the

peaceful end of life. Nursing Outlook, 46(4), 169–175.

Ryan, P., Weiss, M., Traxel, N., & Brondino, M. (2011).

Testing the integrated theory of health behaviour

change for postpartum weight management. Journal of

Advanced Nursing, 67(9), 2047–2059.

Ryan-Wenger, N., Sharrer, V., & Wynd, C. (2000). Stress,

coping, and health in children. In V. Rice (Ed.),

Handbook of stress, coping, and health: Implications for

nursing research, theory, and practice (pp. 265–293).

Thousand Oaks, CA: Sage.

Severtsen, B. M., & Copstead, L. (2000). Stress, adaptation

and coping. In L. Copstead & J. L. Banasik (Eds.),

Pathophysiology: Biological and behavioral perspectives

(pp. 27–29). Philadelphia: Saunders.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improve outcomes.

West Sussex, UK: Wiley-Blackwell.

Siegman, A., & Smith, T. (1994). Anger, hostility, and the

heart. Hillsdale, NJ: Erlbaum.

Smith, C. E., Pace, K., Kochinda, C., Kleinbeck, S.,

Koehler, J., & Popkess-Vawter, S. (2002). Caregiver

effectiveness model evolution to a midrange theory of

home care: A process for critique and replication.

Advances in Nursing Science, 25(1), 50–64.

Spielberger, C., Reheiser, R., & Sydeman, S. (1995).

Measuring the experience, expression, and control of

anger. Washington, DC: Taylor and Francis.

Swanson, K. M. (1991). Empirical development of a

middle range theory of caring. Nursing Research, 40(3),

161–166.

Tang, W. -R., Yu, C. -Y., & Yeh, S. -J. (2010). Fatigue and its

related factors in patients with chronic heart failure.

Journal of Clinical Nursing, 19(1/2), 69–78.

Tao, H., Ellenbecker, C., Chen, J., Zhan, L., & Dalton, J.

(2012). The influence of social environmental factors

on hospitalization among patients receiving home

health care services. Advances in Nursing Science, 35(4),

346–358.

Tsai, P. (2003). A middle-range theory of caregiver stress.

Nursing Science Quarterly, 16(2), 137–145.

Tsai, P., Tak, S., Moore, C., & Palencia, I. (2003). Testing a

theory of chronic pain. Journal of Advanced Nursing, 43

(2), 158–169.

Watson, J. (1985). Nursing: Human science and human

care. A theory of nursing. Norwalk, CT: Appleton &

Lange.

Whittemore, R., & Roy, C. (2002). Adapting to diabetes

mellitus: A theory synthesis. Nursing Science Quarterly,

15(4), 311–317.

209CHAPTER 7 Understanding Theory and Research Frameworks

C H A P T E R

8 Clarifying Quantitative Research Designs

C H A P T E R OV E R V I E W

Identifying Designs Used in Nursing Studies, 212

Descriptive Designs, 212

Typical Descriptive Design, 214

Comparative Descriptive Design, 216

Correlational Designs, 217

Descriptive Correlational Design, 218

Predictive Correlational Design, 220

Model Testing Design, 221

Understanding Concepts Important to Causality

in Designs, 222

Multicausality, 223

Probability, 223

Bias, 223

Control, 224

Manipulation, 224

Examining the Validity of Studies, 224

Statistical Conclusion Validity, 224

Internal Validity, 226

Construct Validity, 227

External Validity, 228

Elements of Designs Examining Causality, 229

Examining Interventions in Nursing Studies, 230

Experimental and Control or Comparison

Groups, 230

Quasi-Experimental Designs, 232

Pretest and Post-test Designs with Comparison

Group, 233

Experimental Designs, 237

Classic Experimental Pretest and Post-test

Designs with Experimental and Control

Groups, 237

Post-test–Only with Control Group Design, 239

Randomized Controlled Trials, 241

Introduction to Mixed-Methods Approaches, 243

Key Concepts, 245

References, 246

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Identify the nonexperimental designs

(descriptive and correlational) and experimental

designs (quasi-experimental and experimental)

commonly used in nursing studies.

2. Critically appraise descriptive and correlational

designs in published studies.

3. Describe the concepts important to examining

causality—multicausality, probability, bias,

control, and manipulation.

4. Examine study designs for strengths and threats

to statistical conclusion, and to internal,

construct, and external validity.

5. Describe the elements of designs that examine

causality.

6. Critically appraise the interventions

implemented in studies.

7. Critically appraise the quasi-experimental

and experimental designs in published

studies.

8. Examine the quality of randomized

controlled trials (RCTs) conducted in

nursing.

9. Discuss the implementation of mixed-methods

approaches in nursing studies.

210

K E Y T E R M S

Bias, p. 223

Blinding, p. 241

Causality, p. 222

Comparative descriptive design,

p. 216

Construct validity, p. 227

Control, p. 224

Control or comparison group,

p. 230

Correlational design, p. 217

Cross-sectional design, p. 212

Descriptive correlational

design, p. 218

Descriptive design, p. 212

Design validity, p. 211

Experimental designs, p. 237

Experimental or treatment

group, p. 230

Experimenter expectancy, p. 228

External validity, p. 228

Internal validity, p. 226

Intervention, p. 230

Intervention fidelity, p. 230

Longitudinal design, p. 212

Low statistical power, p. 226

Manipulation, p. 224

Mixed-methods approaches,

p. 243

Model testing design, p. 221

Multicausality, p. 223

Nonexperimental designs, p. 212

Predictive correlational design,

p. 220

Probability, p. 223

Quasi-experimental design,

p. 232

Randomized controlled trial

(RCT), p. 241

Research design, p. 211

Statistical conclusion validity,

p. 224

Study validity, p. 224

Threats to validity, p. 224

Triangulation, p. 244

Typical descriptive design,

p. 214

A research design is a blueprint for conducting a study. Over the years, several quantitative

designs have been developed for conducting descriptive, correlational, quasi-experimental,

and experimental studies. Descriptive and correlational designs are focused on describing and

examining relationships of variables in natural settings. Quasi-experimental and experimental

designs were developed to examine causality, or the cause and effect relationships between inter-

ventions and outcomes. The designs focused on causality were developed to maximize control

over factors that could interfere with or threaten the validity of the study design. The strengths

of the design validity increase the probability that the study findings are an accurate reflection of

reality. Well-designed studies, especially those focused on testing the effects of nursing interven-

tions, are essential for generating sound research evidence for practice (Brown, 2014; Craig &

Smyth, 2012).

Being able to identify the study design and evaluate design flaws that might threaten the

validity of the findings is an important part of critically appraising studies. Therefore this

chapter introduces you to the different types of quantitative study designs and provides an

algorithm for determining whether a study design is descriptive, correlational, quasi-

experimental, or experimental. Algorithms are also provided so that you can identify specific

types of designs in published studies. A background is provided for understanding causality in

research by defining the concepts of multicausality, probability, bias, control, and manipula-

tion. The different types of validity—statistical conclusion validity, internal validity, construct

validity, and external validity—are described. Guidelines are provided for critically appraising

descriptive, correlational, quasi-experimental, and experimental designs in published studies.

In addition, a flow diagram is provided to examine the quality of randomized controlled trials

conducted in nursing. The chapter concludes with an introduction to mixed-method

approaches, which include elements of quantitative designs and qualitative procedures in

a study.

211CHAPTER 8 Clarifying Quantitative Research Designs

IDENTIFYING DESIGNS USED IN NURSING STUDIES

A variety of study designs are used in nursing research; the four most commonly used types are

descriptive, correlational, quasi-experimental, and experimental. These designs are categorized

in different ways in textbooks (Fawcett & Garity, 2009; Hoe & Hoare, 2012; Kerlinger & Lee,

2000). Sometimes, descriptive and correlational designs are referred to as nonexperimental

designs because the focus is on examining variables as they naturally occur in environments

and not on the implementation of a treatment by the researcher. Some of these nonexperimen-

tal designs include a time element. Designs with a cross-sectional element involve data collec-

tion at one point in time. Cross-sectional design involves examining a group of subjects

simultaneously in various stages of development, levels of education, severity of illness,

or stages of recovery to describe changes in a phenomenon across stages. The assumption is

that the stages are part of a process that will progress over time. Selecting subjects at various

points in the process provides important information about the totality of the process, even

though the same subjects are not monitored throughout the entire process (Grove,

Burns, & Gray, 2013). Longitudinal design involves collecting data from the same subjects

at different points in time and might also be referred to as repeated measures. Repeated mea-

sures might be included in descriptive, correlational, quasi-experimental, or experimental study

designs.

Quasi-experimental and experimental studies are designed to examine causality or the cause

and effect relationship between a researcher-implemented treatment and selected study outcome.

The designs for these studies are sometime referred to as experimental because the focus is on

examining the differences in dependent variables thought to be caused by independent variables

or treatments. For example, the researcher-implemented treatment might be a home monitoring

program for patients initially diagnosed with hypertension, and the dependent or outcome vari-

able could be blood pressure measured at 1 week, 1 month, and 6 months. This chapter introduces

you to selected experimental designs and provides examples of these designs from published nurs-

ing studies. Details on other study designs can be found in a variety of methodology sources

(Campbell & Stanley, 1963; Creswell, 2014; Grove et al., 2013; Kerlinger & Lee, 2000; Shadish,

Cook, & Campbell, 2002).

The algorithm shown in Figure 8-1 may be used to determine the type of design (descriptive,

correlational, quasi-experimental, and experimental) used in a published study. This algorithm

includes a series of yes or no responses to specific questions about the design. The algorithm starts

with the question, “Is there a treatment?” The answer leads to the next question, with the four types

of designs being identified in the algorithm. Sometimes, researchers combine elements of different

designs to accomplish their study purpose. For example, researchers might conduct a cross-

sectional, descriptive, correlational study to examine the relationship of body mass index

(BMI) to blood lipid levels in early adolescence (ages 13 to 16 years) and late adolescence (ages

17 to 19 years). It is important that researchers clearly identify the specific design they are using

in their research report.

DESCRIPTIVE DESIGNS

Descriptive studies are designed to gain more information about characteristics in a particular field

of study. The purpose of these studies is to provide a picture of a situation as it naturally happens.

A descriptive design may be used to develop theories, identify problems with current practice,

212 CHAPTER 8 Clarifying Quantitative Research Designs

make judgments about practice, or identify trends of illnesses, illness prevention, and health pro-

motion in selected groups. No manipulation of variables is involved in a descriptive design. Pro-

tection against bias in a descriptive design is achieved through (1) conceptual and operational

definitions of variables, (2) sample selection and size, (3) valid and reliable instruments, and

(4) data collection procedures that might partially control the environment. Descriptive studies

differ in level of complexity. Some contain only two variables; others may include multiple vari-

ables that are studied over time. You can use the algorithm shown in Figure 8-2 to determine the

type of descriptive design used in a published study. Typical descriptive and comparative descrip-

tive designs are discussed in this chapter. Grove and colleagues (2013) have provided details about

additional descriptive designs.

YesNo

YesNo

Yes

Is the primary purpose examination of relationships?

Is there a treatment?

Is the treatment tightly controlled by the researcher?

No

Descriptive design

Will the sample be studied as a

single group?

Correlational design

YesNo

Quasi-experimental study

Will a randomly assigned comparison

or control group be used?

YesNo

Is the original sample randomly

selected?

Experimental study

YesNo

FIG 8-1 Algorithm for determining the type of study design.

213CHAPTER 8 Clarifying Quantitative Research Designs

Typical Descriptive Design A typical descriptive design is used to examine variables in a single sample (Figure 8-3). This

descriptive design includes identifying the variables within a phenomenon of interest, measuring

these variables, and describing them. The description of the variables leads to an interpretation of

the theoretical meaning of the findings and the development of possible relationships or hypoth-

eses that might guide future correlational or quasi-experimental studies.

NoYes

Longitudinal design with treatment

partitioning

Cross-sectional design with treatment

partitioning

YesNo

Repeated measures of

each subject?

Trend analysis

YesNo

Study events partitioned

across time?

Cross- sectional design

YesNo Yes

One group?

Examining sequences across time?

Following same subjects across time?

No

Descriptive design

Comparative descriptive

design Data collected across time?

YesNo

YesNo

Single unit of study?

Longitudinal study

Case study

FIG 8-2 Algorithm for determining the type of descriptive design.

214 CHAPTER 8 Clarifying Quantitative Research Designs

Phenomenon of interest

Variable 1

Interpretation of meaning

Development of hypotheses

MEASUREMENT DESCRIPTION INTERPRETATIONCLARIFICATION

Variable 2

Variable 3

Variable 4 Description of variable 4

Description of variable 3

Description of variable 2

Description of variable 1

FIG 8-3 Typical descriptive design.

? CRITICAL APPRAISAL GUIDELINES Descriptive and Correlational Designs

When critically appraising the designs of descriptive and correlational studies, you need to address the following

questions:

1. Is the study design descriptive or correlational? Review the algorithm in Figure 8-1 to determine the type of

study design.

2. If the study design is descriptive, use the algorithm in Figure 8-2 to identify the specific type of descriptive

design implemented in the study.

3. If the study design is correlational, use the algorithm in Figure 8-5 to identify the specific type of correlational

design implemented in the study.

4. Does the study design address the study purpose and/or objectives or questions?

5. Was the sample appropriate for the study?

6. Were the study variables measured with quality measurement methods?

RESEARCH EXAMPLE

Typical Descriptive Design

Research Study Excerpt Maloni, Przeworski, and Damato (2013) studied women with postpartum depression (PPD) after pregnancy com-

plications for the purpose of describing their barriers to treatment for PPD, use of online resources for assistance

with PPD, and preference for Internet treatment for PPD. This study included a typical descriptive design; key

aspects of this study’s design are presented in the following excerpt.

“Methods

An exploratory descriptive survey design was used to obtain a convenience sample of women who self-

report feelings of PPD across the past week [sample size n¼53]. Inclusion criteria were women between Continued

215CHAPTER 8 Clarifying Quantitative Research Designs

Comparative Descriptive Design A comparative descriptive design is used to describe variables and examine differences in variables

in two or more groups that occur naturally in a setting. A comparative descriptive design compares

descriptive data obtained from different groups, which might have been formed using gender, age,

educational level, medical diagnosis, or severity of illness. Figure 8-4 provides a diagram of this

design’s structure.

RESEARCH EXAMPLE—cont’d

2 weeks and 6 months postpartum who had been hospitalized for pregnancy complications. Women were

excluded if they had a score of <6 on the Edinburgh Postnatal Depression Scale (EPDS). . .. EPDS is a widely

used screening instrument to detect postpartum depression. . ..

In addition, a series of 26 descriptive questions assessed women’s barriers to PPD treatment, whether

they sought information about depression after birth from any sources and their information seeking about

PPD from the Internet, how often they sought the information, and whether the information was helpful.

Questions were developed from review of the literature.. . . Content validity was established by a panel of

four experts.. . . The survey was posted using a university-protected website using standardized software

for surveys.” (Maloni et al., 2013, pp. 91-92)

Critical Appraisal Maloni and associates (2013) clearly identified their study design as descriptive and indicated that the data were

collected using an online survey. This type of design was appropriate to address the study purpose. The sample

section was strengthened by using the EPDS to identify women with PPD and using the sample criteria to ensure

that the women had been hospitalized for pregnancy complications. However, the sample size of 53 was small for a

descriptive study. The 26-item questionnaire had content validity and was consistently implemented online using

standard survey software. This typical descriptive design was implemented in a way to provide quality study

findings.

Implications for Practice Maloni and co-workers (2013) noted that of the 53 women who were surveyed because they reported PPD, 70% had

major depression. The common barriers that prevented them from getting treatment included time and the stigma

of PPD diagnosis. Over 90% of the women did use the Internet as a resource to learn about coping with PPD and

expressed an interest in a web-based PPD treatment.

Group I (variable[s] measured)

Describe

Comparison of groups on

select variables

Interpretation of meaning

Group II (variable[s] measured)

Describe Development of hypotheses

FIG 8-4 Comparative descriptive design.

216 CHAPTER 8 Clarifying Quantitative Research Designs

CORRELATIONAL DESIGNS

The purpose of a correlational design is to examine relationships between or among two or

more variables in a single group in a study. This examination can occur at any of several levels—

descriptive correlational, in which the researcher can seek to describe a relationship, predictive cor-

relational, in which the researcher can predict relationships among variables, or the model testing

design, in which all the relationships proposed by a theory are tested simultaneously.

In correlational designs, a large range in the variable scores is necessary to determine the exis-

tence of a relationship. Therefore the sample should reflect the full range of scores possible on the

variables being measured. Some subjects should have very high scores and others very low scores,

RESEARCH EXAMPLE

Comparative Descriptive Design

Research Study Excerpt Buet and colleagues (2013) conducted a comparative descriptive study to describe and determine differences in the

hand hygiene (HH) opportunities and adherence of clinical (e.g., nurses and physicians) and nonclinical (e.g.,

teachers and parents) caregivers for patients in pediatric extended-care facilities (ECFs). The following study excerpt

includes key elements of this comparative descriptive design:

“Eight children across four pediatric ECFs were observed for a cumulative 128 hours, and all caregiver HH

opportunities were characterized by the World Health Organization [WHO] ‘5 Moments for HH.’. . . A conve-

nience sample of two children from each site (n¼8) was observed. . . . Four observers participated in two hours of didactic training and two hours of monitored practice observations at one of the four study sites

to ensure consistent documentation and interpretation of observations. Observers learned how to accurately

record HH opportunities and HH adherence using the WHO ‘5 Moments of HH’ data acquisition tool, dis-

cussed below. Throughout the study, regular debriefings were also held to review and discuss data

recording.. . .The World Health Organization (WHO, 2009) ‘5 Moments for HH’ define points of contact when

healthcare workers should perform HH: ‘before touching a patient, before clean/aseptic procedures, after

body fluid exposure/risk, after touching a patient, and after touching patient surroundings. . .. During approx-

imately 128 hours of observation, 865 HH opportunities were observed.” (Buet et al., 2013, pp. 72-73)

Critical Appraisal Buet and associates (2013) clearly described the aspects of their study design but did not identify the specific type of

design used in their study. The design was comparative descriptive because the HH opportunities and adherence for

clinical and nonclinical caregivers were described and compared. The study included 128 hours of observation

(16 hours per child) of 865 HH opportunities in four different ECF settings. Thus the sampling process was strong

and seemed focused on accomplishing the study purpose. The data collectors were well trained and monitored to

ensure consistent observation and recording of data. HH was measured using an observational tool based on inter-

national standards (WHO, 2009) for HH.

Implications for Practice Buet and co-workers (2013) found that the HH of the clinical caregivers was significantly higher than the nonclinical

caregivers. However, the overall HH adherence for the clinical caregivers was only 43%. The low HH adherence

suggested increased potential for transmission of infections among children in ECFs. Additional HH education

is needed for clinical and nonclinical caregivers of these children to prevent future adverse events. Quality and Safety

Education for Nurses (QSEN, 2013) implications from this study encourage nurses to follow evidence-based prac-

tice (EBP) guidelines in adhering to HH measures to ensure safe care of their patients and reduce their risk of poten-

tially life-threatening infections (Sherwood & Barnsteiner, 2012).

217CHAPTER 8 Clarifying Quantitative Research Designs

and the scores of the rest should be distributed throughout the possible range. Because of the need

for a wide variation on scores, correlational studies generally require large sample sizes. Subjects are

not divided into groups, because group differences are not examined. To determine the type of

correlational design used in a published study, use the algorithm shown in Figure 8-5. More details

on correlational designs referred to in this algorithm are available from other sources (Grove et al.,

2013; Kerlinger & Lee, 2000).

Descriptive Correlational Design The purpose of a descriptive correlational design is to describe variables and examine relation-

ships among these variables. Using this design facilitates the identification of many interrelation-

ships in a situation (Figure 8-6). The study may examine variables in a situation that has already

occurred or is currently occurring. Researchers make no attempt to control or manipulate the sit-

uation. As with descriptive studies, variables must be clearly identified and defined conceptually

and operationally (see Chapter 5).

Describe relationships between/among

variables?

Descriptive correlational design

Predict relationships between/among

variables?

Predictive correlational design

Test theoretically proposed

relationships?

Model testing design

FIG 8-5 Algorithm for determining the type of correlational design.

Research variable

1

Interpretation of meaning

Description of variable

Description of variable

Examination of relationship

Research variable

2

Development of hypotheses

MEASUREMENT

FIG 8-6 Descriptive correlational design.

218 CHAPTER 8 Clarifying Quantitative Research Designs

RESEARCH EXAMPLE

Descriptive Correlational Design

Research Study Excerpt Burns, Murrock, and Graor (2012) conducted a correlational study to examine the relationship between BMI and

injury severity in adolescent males attending a National Boy Scout Jamboree. The key elements of this descriptive

correlational design are presented in the following study excerpt.

“Design

This study used a descriptive, correlational design to examine the relationship between obesity and injury

severity. . . . The convenience sample consisted of the 611 adolescent males, aged 11-17 years, who

received medical attention for an injury at one of eight participating medical facilities. Exclusion criteria were

adolescent males presenting with medical complaints unrelated to an injury (e.g., sore throat, dehydration,

insect bite) and those who were classified as ‘special needs’ participants because of the disability affecting

their mobility or requiring the use of an assistive device. . . . There were 20 medical facilities located through-

out the 2010 National Boy Scout Jamboree. Each facility was equipped to manage both medical complaints

and injuries. . . .” (Burns et al., 2012, pp. 509–510)

“Measures

Past medical history, weight (in pounds) and height (in inches) were obtained from the HMR [health and med-

ical record]. BMI [body mass index] and gender-specific BMI percentage were calculated electronically using

online calculators from the Centers for Disease Control and Prevention and height and weight data. The BMI

value was plotted on the CDC’s gender-specific BMI-for-age growth chart to obtain a percentile ranking

(BMI-P). . .. BMI-P defines four weight status categories: less than 5% is considered underweight, 5% to less

than 85% is categorized healthy weight, 85% to less than 95% is the overweight category, and 95% or

greater is categorized as obese. Age was measured in years and was self-reported.

Severity of injury was measured using the ESI [Emergency Severity Index] Version 4. This five-level

triage rating scale was developed by the Agency for Healthcare Research and Quality and provides rapid,

reproducible, clinically relevant stratification of patients into levels based on acuity and resource needs.. . .

Training sessions were held for each medical facility to educate staff on the project, process, data col-

lection techniques, and injury severity scoring methods.. . . All BMI and BMI-P values were recalculated

to verify accuracy. To assess interrater reliability for injury severity scoring, ESI scores reported were

compared with the primary researcher’s scores. When discrepancies were found, the primary researcher

reviewed the treatment record to determine the most accurate score.” (Burns et al., 2012, p. 510)

Critical Appraisal Descriptive Correlational Design Burns and colleagues (2012) clearly identified their study design in their research report. The sampling method was a

nonrandom sample of convenience that is commonly used in descriptive and correlational studies. Nonrandom

sampling methods decrease the sample’s representativeness of the population; however, the sample size was large

and included 20 medical facilities at a national event. The exclusion sampling criteria ensured that the subjects

selected were most appropriate to address the study purpose. The adolescents’ height and weight were obtained

from their medical records but the researchers did not indicate if these were reported or measured by the healthcare

professionals. Self-reported height and weight for subjects could decrease the accuracy of the BMI and BMI-P cal-

culated in a study. The BMI-P and severity injury scores were obtained using reliable and valid measurement

methods, and the data from the medical facilities were checked for accuracy. The design of this study seemed strong

and the knowledge generated provides a basis for future research.

Implications for Practice Burns and associates (2012) found a significant relationship between BMI-P and injury severity. They noted that

overweight/obese adolescents may have increased risks of serious injuries. Additional research is needed to examine

the relationship of BMI to injury risk and to identify ways to prevent injuries in these adolescents. The findings from

this study also emphasize the importance of healthy weight in adolescents to prevent health problems. QSEN (2013)

implications are that evidence-based knowledge about the relationship between obesity and severity of injury pro-

vides nurses and students with information for educating adolescents to promote their health.

Predictive Correlational Design The purpose of a predictive correlational design is to predict the value of one variable based on

the values obtained for another variable or variables. Prediction is one approach to examining

causal relationships between variables. Because causal phenomena are being examined, the terms

dependent and independent are used to describe the variables. The variable to be predicted is clas-

sified as the dependent variable, and all other variables are independent or predictor variables.

A predictive correlational design study attempts to predict the level of a dependent variable from

the measured values of the independent variables. For example, the dependent variable of med-

ication adherence could be predicted using the independent variables of age, number of medica-

tions, and medication knowledge of patients with congestive heart failure. The independent

variables that are most effective in prediction are highly correlated with the dependent variable

but are not highly correlated with other independent variables used in the study. The predictive

correlational design structure is presented in Figure 8-7. Predictive correlational designs require

the development of a theory-based mathematical hypothesis proposing variables expected to pre-

dict the dependent variable effectively. Researchers then use regression analysis to test the hypoth-

esis (see Chapter 11).

Value of Intercept

+ + = Value of

Independent Variable 1

Value of Independent

Variable 2

Predicted Value of

Dependent Variable

FIG 8-7 Predictive correlational design.

RESEARCH EXAMPLE

Predictive Correlational Design

Research Study Excerpt Coyle (2012) used a predictive correlational design to determine if depressive symptoms were predictive of self-care

behaviors in adults who had suffered a myocardial infarction (MI). The following study excerpt presents key ele-

ments of this design.

“Design, Setting, and Sample A descriptive correlational design examined the relationship between the independent variable of depressive

symptoms [agitation and loss of energy] and the dependent variable of self-care. Data were collected from 62

patients in one hospital, who were recovering from an MI in the metropolitan Washington, areaA. . . .” (Coyle,

2012, p. 128)

Measures

“Beck Depression Inventory II

Depressive symptoms were measured using the BDI-II [Beck Depression Inventory II], a well-validated, 21-

item scale designed to measure self-reported depressive symptomatology. . . . Internal-consistency esti-

mates coefficient alpha of the total scores were .92 for psychiatric outpatients and .93 for college students.

Construct validity was .93 (p<.001) when correlated with the BDI-I. In this study, the BDI-II Cronbach’s alpha

was .68 at baseline.” (Coyle, 2012, p. 128)

“Health Behavior Scale

Self-care behaviors after an MI were measured by the Health Behavior Scale (HBS), developed specifically for

measuring the extent to which persons with cardiac disease perform prescribed self-care behaviors. . . . This

220 CHAPTER 8 Clarifying Quantitative Research Designs

Model Testing Design Some studies are designed specifically to test the accuracy of a hypothesized causal model (see

Chapter 7 for content on middle range theory). The model testing design requires that all concepts

relevant to the model be measured and the relationships among these concepts examined. A large

heterogeneous sample is required. Correlational analyses are conducted to determine the relation-

ships among the model concepts, and the results are presented in the framework model for the

study. This type of design is very complex; this text provides only an introduction to a model test-

ing design implemented by Battistelli, Portoghese, Galletta, and Pohl (2013).

self-report, a 20-item instrument, assesses the degree to which patients perform five types of prescribed

self-care (following diet, limiting smoking, performing activities, taking medications, and changing responses

to stressful situations).. . . Cronbach’s alphas for different self-care behaviors ranged from .82 to .95. In this

study, reliability was measured by Cronbach’s alpha and was .62 at 2 weeks and .71 at 30 days. . ..Prior to

hospital discharge, the Medical and Demographic Characteristics Questionnaire and BDI-II were adminis-

tered by the researcher.. . . At 2 weeks and at 30 days after hospital discharge, participants were contacted

by telephone to determine responses to the HBS.” (Coyle, 2012, pp. 128-129)

Critical Appraisal Coyle (2012) might have identified her study design more clearly as predictive correlational but did clearly identify

the dependent variable as self-care and the independent variables as depressive symptoms. The design also included

the longitudinal measurement of self-care with the HBS at 2 weeks and 30 days. The design was appropriate to

accomplish the study purpose. The sample of 62 subjects was adequate because the study findings indicated sig-

nificant results. The BDI-II has documented reliability (Cronbach’s alphas>0.7) and validity from previous studies, but the reliability of .68 was low in this study. Reliability indicates how consistently the scale measured depression

and, in this study, it had 68% consistency and 32% error (1.00�.68¼ .32�100%¼32%; see Chapter 10). HBS had strong reliability in previous studies but the validity of the scale was not addressed. The reliability of HBS was limited

at 2 weeks (62% reliable and 38% error) but acceptable at 30 days (71% reliable and 29% error). This study has a

strong design with more strengths than weaknesses, and the findings are probably an accurate reflection of reality.

The study needs to be replicated with stronger measurement methods and a larger sample.

Implications for Practice Coyle (2012) found that depressive symptoms of agitation and loss of energy were significantly predictive of self-

care performance in patients with an MI at 30 days post–hospital discharge. Coyle recommended screening post-MI

patients for depressive symptoms so that their symptoms might be managed before they were discharged. Further

research is recommended to examine depression and self-care behaviors after hospital discharge to identify and treat

potential problems.

RESEARCH EXAMPLE

Model Testing Design

Research Study Battistelli and co-workers (2013) developed and tested a theoretical model to examine turnover intentions of nurses

working in hospitals. The concepts of work-family conflict, job satisfaction, community embeddedness, and orga-

nizational affective commitment were identified as predictive of nurse turnover intention. The researchers collected

data on these concepts using a sample of 440 nurses from a public hospital. The analysis of study data identified

significant relationships (p<0.05) among all concepts in the model. The results of this study are presented in Figure 8-8 and indicate the importance of these concepts in predicting nurse turnover intention.

Continued

221CHAPTER 8 Clarifying Quantitative Research Designs

UNDERSTANDING CONCEPTS IMPORTANT TO CAUSALITY IN DESIGNS

Quasi-experimental and experimental designs were developed to examine causality or the effect of

an intervention on selected outcomes. Causality basically says that things have causes, and causes

lead to effects. In a critical appraisal, you need to determine whether the purpose of the study is to

examine causality, examine relationships among variables (correlational designs), or describe vari-

ables (descriptive designs). You may be able to determine whether the purpose of a study is to

examine causality by reading the purpose statement and propositions within the framework

(see Chapter 7). For example, the purpose of a causal study may be to examine the effect of a

specific, preoperative, early ambulation educational program on length of hospital stay. The prop-

osition may state that preoperative teaching results in shorter hospitalizations. However, the pre-

operative early ambulation educational program is not the only factor affecting length of hospital

stay. Other important factors include the diagnosis, type of surgery, patient’s age, physical condi-

tion of the patient prior to surgery, and complications that occurred after surgery. Researchers

usually design quasi-experimental and experimental studies to examine causality or the effect

of an intervention (independent variable) on a selected outcome (dependent variable), using a

design that controls extraneous variables. Critically appraising studies designed to examine cau-

sality requires an understanding of such concepts as multicausality, probability, bias, control, and

manipulation.

RESEARCH EXAMPLE—cont’d

Affective CommitmentJob Satisfaction

Work–Family Conflict

Community Embeddedness

Tumover Intention–.15

.24

.16

–.43

.64

.15

–.29

FIG 8-8 Results of the structural equation modeling analysis of the hypothesized model of turnover intention on the cross-validation sample (n¼440, standardized path loadings, p<0.05, two-tailed). (From Battistelli, A., Portoghese, I., Galletta, M., & Pohl, S. [2012]. Beyond the tradition: Test of an integrative conceptual model on nurse turnover. International Nursing Review, 60(1), p. 109.)

222 CHAPTER 8 Clarifying Quantitative Research Designs

Multicausality Very few phenomena in nursing can be clearly linked to a single cause and a single effect. A number

of interrelating variables can be involved in producing a particular effect. Therefore studies devel-

oped from a multicausal perspective will include more variables than those using a strict causal

orientation. The presence of multiple causes for an effect is referred to as multicausality. For exam-

ple, patient diagnosis, age, presurgical condition, and complications after surgery will be involved

in causing the length of hospital stay. Because of the complexity of causal relationships, a theory is

unlikely to identify every element involved in causing a particular outcome. However, the greater

the proportion of causal factors that can be identified and examined or controlled in a single study,

the clearer the understanding will be of the overall phenomenon. This greater understanding is

expected to increase the ability to predict and control the effects of study interventions.

Probability Probability addresses relative rather than absolute causality. A cause may not produce a specific

effect each time that a particular cause occurs, and researchers recognize that a particular cause

probably will result in a specific effect. Using a probability orientation, researchers design studies

to examine the probability that a given effect will occur under a defined set of circumstances. The

circumstances may be variations in multiple variables. For example, while assessing the effect of

multiple variables on length of hospital stay, researchers may choose to examine the probability of a

given length of hospital stay under a variety of specific sets of circumstances. One specific set of

circumstances may be that the patients in the study received the preoperative early ambulation

educational program, underwent a specific type of surgery, had a particular level of health before

surgery, and experienced no complications after surgery. Sampling criteria could be developed to

control most of these factors. The probability of a given length of hospital stay could be expected to

vary as the set of circumstances are varied or controlled in the design of the study.

Bias The term bias means a slant or deviation from the true or expected. Bias in a study distorts

the findings from what the results would have been without the bias. Because studies are con-

ducted to determine the real and the true, researchers place great value on identifying and

removing sources of bias in their study or controlling their effects on the study findings.

Quasi-experimental and experimental designs were developed to reduce the possibility and

effects of bias. Any component of a study that deviates or causes a deviation from a true mea-

surement of the study variables contributes to distorted findings. Many factors related to

research can be biased; these include attitudes or motivations of the researcher (conscious or

unconscious), components of the environment in which the study is conducted, selection of

the individual subjects, composition of the sample, groups formed, measurement methods, data

collection process, data, and statistical analyses. For example, some of the subjects for the study

might be taken from a unit of the hospital in which the patients are participating in another study

involving high-quality nursing care or one nurse, selecting patients for the study, might assign

the patients who are most interested in the study to the experimental group. Each of these sit-

uations introduces bias to the study.

An important focus in critically appraising a study is to identify possible sources of bias. This

requires careful examination of the methods section in the research report, including strategies for

obtaining subjects, implementing a study treatment, and performing measurements. However, not

all biases can be identified from the published report of a study. The article may not provide suf-

ficient detail about the methods of the study to detect some of the biases.

223CHAPTER 8 Clarifying Quantitative Research Designs

Control One method of reducing bias is to increase the amount of control in the design of a study. Control

means having the power to direct or manipulate factors to achieve a desired outcome. For example,

in a study of preoperative early ambulation educational program, subjects may be randomly

selected and then randomly assigned to the experimental group or control group. The researcher

may control the duration of the educational program or intervention, content taught, method of

teaching, and teacher. The time that the teaching occurred in relation to surgery also may be con-

trolled, as well as the environment in which it occurred. Measurement of the length of hospital stay

may be controlled by ensuring that the number of days, hours, and minutes of the hospital stay is

calculated exactly the same way for each subject. Limiting the characteristics of subjects, such as

diagnosis, age, type of surgery, and incidence of complications, is also a form of control. The

greater the researcher’s control over the study situation, the more credible (or valid) the study

findings.

Manipulation Manipulation is a form of control generally used in quasi-experimental and experimental studies.

Controlling the treatment or intervention is the most commonly used manipulation in these stud-

ies. In descriptive and correlational studies, little or no effort is made to manipulate factors in the

circumstances of the study. Instead, the purpose is to examine the situation as it exists in a natural

environment or setting. However, when quasi-experimental and experimental designs are imple-

mented, researchers must manipulate the intervention under study. Researchers need to develop

quality interventions that are implemented in consistent ways by trained individuals. This con-

trolled manipulation of a study’s intervention decreases the potential for bias and increases the

validity of the study findings. Examining the quality of interventions in studies is discussed in more

detail later in this chapter.

EXAMINING THE VALIDITY OF STUDIES

Determiningthe validityofastudy’sdesignanditsfindingsisessentialtothecriticalappraisalprocess.

Study validity isa measure of the truth or accuracyof the findings obtained from a study. The validity

of a study’s design is central to obtaining quality results and findings from a study. Critical appraisal

of studies requires that you think through the threats to validity or the possible problems in a study’s

design. You need to make judgments about how serious are these threats and how they might affect

the quality of the study’s findings. Strengths and threats to a study’s validity provide a major basis for

making decisions about which findings are accurate and might be ready for use in practice (Brown,

2014). Shadish and associates (2002) have described four types of validity—statistical conclusion

validity, internal validity, construct validity, and external validity. Table 8-1 describes these four types

of validity and summarizes the threats common to each. Understanding these types of validity and

their possible threats are important in critically appraising quasi-experimental and experimental

studies.

Statistical Conclusion Validity The first step in inferring cause is to determine whether the independent and dependent variables

are related. You can determine this relationship through statistical analysis. Statistical conclusion

validity is concerned with whether the conclusions about relationships or differences drawn from

statistical analysis are an accurate reflection of the real world. The second step is to identify

224 CHAPTER 8 Clarifying Quantitative Research Designs

TABLE 8-1 TYPES OF VALIDITY CRITICALLY APPRAISED IN STUDIES

TYPES OF

VALIDITY DESCRIPTION THREATS TO VALIDITY

Statistical

conclusion

validity

Validity is concerned

with whether the

conclusions about

relationships or

differences drawn

from statistical

analysis are an

accurate reflection of

the real world.

Low statistical power: Concluding that there are no differences

between samples when one exists (type II error), which is

usually caused by small sample size.

Unreliable measurement methods: Scales or physiological

measures used in a study are not consistently measuring study

variables.

Unreliable intervention implementation: The intervention in a

study is not consistently implemented because of lack of study

protocol or training of individuals implementing the intervention.

Extraneous variances in study setting: Extraneous variables in

the study setting influence the scores on the dependent

variables, making it difficult to detect group differences.

Internal validity Validity is focused on

determining if study

findings are accurate

or are the result of

extraneous

variables.

Subject selection and assignment to group concerns: The

subjects are selected by nonrandom sampling methods and are

not randomly assigned to groups.

Subject attrition: The percentage of subjects withdrawing from

the study is high or more than 25%.

History: An event not related to the planned study occurs during

the study and could have an impact on the findings.

Maturation: Changes in subjects, such as growing wiser, more

experienced, or tired, which might affect study results.

Construct

validity

Validity is concerned

with the fit between

the conceptual and

operational

definitions of

variables and that

the instrument

measures what it is

supposed to in the

study.

Inadequate definitions of constructs: Constructs examined in a

study lack adequate conceptual or operational definitions, so the

measurement method is not accurately capturing what it is

supposed to in a study.

Mono-operation bias: Only one measurement method is used to

measure the study variable.

Experimenter expectancies (Rosenthal effect): Researchers’

expectations or bias might influence study outcomes, which

could be controlled by blinding researchers and data collectors to

the group receiving the study intervention.

External validity Validity is concerned

with the extent to

which study findings

can be generalized

beyond the sample

used in the study.

Interaction of selection and treatment: The subjects

participating in the study might be different than those who

decline participation. If the refusal to participate is high, this

might alter the effects of the study intervention.

Interaction of setting and treatment: Bias exists in study

settings and organizations that might influence implementation

of a study intervention. For example, some settings are more

supportive and assist with a study, and others are less

supportive and might encourage patients not to participate in a

study.

Interaction of history and treatment: An event, such as closing

a hospital unit, changing leadership, or high nursing staff

attrition, might affect the implementation of the intervention and

measurement of study outcomes, which would decrease

generalization of findings.

225CHAPTER 8 Clarifying Quantitative Research Designs

differences between groups. There are reasons why false conclusions can be drawn about the pres-

ence or absence of a relationship or difference. The reasons for the false conclusions are called

threats to statistical conclusion validity (see Table 8-1). This text discusses some of the more com-

mon threats to statistical conclusion validity that you might identify in studies, such as low sta-

tistical power, unreliable measurement methods, unreliable intervention implementation, and

extraneous variances in study setting. Shadish et al. –([2002)- provide a more detailed discussion

of statistical conclusion validity.

Low Statistical Power

Low statistical power increases the probability of concluding that there is no significant difference

between samples when actually there is a difference (type II error). A type II error is most likely to

occur when the sample size is small or when the power of the statistical test to determine differ-

ences is low (Cohen, 1988). You need to ensure that the study has adequate sample size and power

to detect relationships and differences. The concepts of sample size, statistical power, and type II

error are discussed in detail in Chapters 9 and 11.

Reliability or Precision of Measurement Methods The technique of measuring variables must be reliable to reveal true differences. A measure is reli-

able if it gives the same result each time the same situation or factor is measured. If a scale used to

measure depression is reliable, it should give similar scores when depression is repeatedly measured

over a short time period (Waltz, Strickland, & Lenz, 2010). Physiological measures that consis-

tently measure physiological variables are considered precise. For example, a thermometer would

be precise if it showed the same reading when tested repeatedly on the same patient within a lim-

ited time (see Chapter 10). You need to examine the measurement methods in a study and deter-

mine if they are reliable.

Reliability of Intervention Implementation

Intervention reliability ensures that the research treatment or intervention is standardized and

applied consistently each time it is implemented in a study. In some studies, the consistent imple-

mentation of the treatment is referred to as intervention fidelity (see later). If the method of

administering a research intervention varies from one person to another, the chance of detecting

a true difference decreases. The inconsistent or unreliable implementation of a study intervention

creates a threat to statistical conclusion validity.

Extraneous Variances in the Study Setting Extraneous variables in complex settings (e.g., clinical units) can influence scores on the depen-

dent variable. These variables increase the difficulty of detecting differences between the experi-

mental and control groups. Consider the activities that occur on a nursing unit. The numbers

and variety of staff, patients, health crises, and work patterns merge into a complex arena for

the implementation of a study. Any of the dynamics of the unit can influence manipulation of

the independent variable or measurement of the dependent variable. You might review the

methods section of the study and determine how extraneous variables were controlled in the study

setting.

Internal Validity Internal validity is the extent to which the effects detected in the study are a true reflection of

reality rather than the result of extraneous variables. Although internal validity should be a concern

226 CHAPTER 8 Clarifying Quantitative Research Designs

in all studies, it is usually addressed in relation to studies examining causality than in other studies.

When examining causality, the researcher must determine whether the dependent variables may

have been influenced by a third, often unmeasured, variable (an extraneous variable). The possi-

bility of an alternative explanation of cause is sometimes referred to as a rival hypothesis (Shadish

et al., 2002). Any study can contain threats to internal design validity, and these validity threats

can lead to false-positive or false-negative conclusions (see Table 8-1). The researcher must

ask, “Is there another reasonable (valid) explanation (rival hypothesis) for the finding other than

the one I have proposed?” Some of the common threats to internal validity, such as subject selec-

tion and assignment to groups, subject attrition, history, and maturation, are discussed in this

section.

Subject Selection and Assignment to Groups Selection addresses the process whereby subjects are chosen to take part in a study and how

subjects are grouped within a study. A selection threat is more likely to occur in studies in which

randomization is not possible (Grove et al., 2013; Shadish et al., 2002). In some studies, people

selected for the study may differ in some important way from people not selected for the study.

In other studies, the threat is a result of the differences in subjects selected for study groups.

For example, people assigned to the control group could be different in some important way

from people assigned to the experimental group. This difference in selection could cause the

two groups to react differently to the treatment or intervention; in this case, the intervention would

not have caused the differences in group outcomes. Random selection of subjects in nursing stud-

ies is often not possible, and the number of subjects available for studies is limited. The random

assignment of subjects to groups decreases the possibility of subject selection being a threat to

internal validity.

Subject Attrition Subject attrition involves participants dropping out of a study before it is completed. Subject attrition

becomesa threatwhen(1)thosewho dropoutofa studyare a different typeofperson fromthose who

remain in the study or (2) there is a difference between the types of people who drop out of the exper-

imental group and the people who drop out of the control or comparison group (see Chapter 9).

History History is an event that is not related to the planned study but that occurs during the time of

the study. History could influence a subject’s response to the treatment and alter the outcome

of the study. For example, if you are studying the effect of an emotional support intervention

on subjects’ completion of their cardiac rehabilitation program, and several nurses quit their

job at the center during your study, this historical event would create a threat to the study’s internal

design validity.

Maturation

In research, maturation is defined as growing older, wiser, stronger, hungrier, more tired, or more

experienced during the study. Such unplanned and unrecognized changes are a threat to the study’s

internal validity and can influence the findings of the study.

Construct Validity Construct validity examines the fit between the conceptual and operational definitions of vari-

ables. Theoretical constructs or concepts are defined within the study framework (conceptual

227CHAPTER 8 Clarifying Quantitative Research Designs

definitions). These conceptual definitions provide the basis for the operational definitions of the

variables. Operational definitions (methods of measurement) must validly reflect the theoretical

constructs. (Theoretical constructs were discussed in Chapter 7; conceptual and; operational def-

initions of variables and concepts are discussed in Chapter 5.) The process of developing construct

validity for an instrument often requires years of scientific work, and researchers need to discuss

the construct validity of the instruments that they used in their study (Shadish et al., 2002; Waltz

et al., 2010). (Instrument construct validity is discussed in Chapter 10.) The threats to construct

validity are related to previous instrument development and to the development of measurement

techniques as part of the methodology of a particular study. Threats to construct validity are

described here and summarized in Table 8-1.

Inadequate Definitions of Constructs Measurement of a construct stems logically from a concept analysis of the construct by the theorist

who developed the construct or by the researcher. The conceptual definition should emerge from

the concept analysis, and the method of measurement (operational definition) should clearly

reflect both. A deficiency in the conceptual or operational definition leads to low construct validity

(see Chapter 5).

Mono-operation Bias Mono-operation bias occurs when only one method of measurement is used to assess a construct.

When only one method of measurement is used, fewer dimensions of the construct are measured.

Construct validity greatly improves if the researcher uses more than one instrument (Waltz et al.,

2010). For example, if pain were a dependent variable, more than one measure of pain could be

used, such as a pain rating scale, verbal reports of pain, and observations of behaviors that reflect

pain (crying, grimacing, and pulling away). It is sometimes possible to apply more than one mea-

surement of the dependent variable with little increase in time, effort, or cost.

Experimenter Expectancies (Rosenthal Effect) The expectancies of the researcher can bias the data. For example, experimenter expectancy

occurs if a researcher expects a particular intervention to relieve pain. The data that he or she col-

lects may be biased to reflect this expectation. If another researcher who does not believe the inter-

vention would be effective had collected the data, results could have been different. The extent to

which this effect actually influences studies is not known. Because of their concern about exper-

imenter expectancy, some researchers are not involved in the data collection process. In other stud-

ies, data collectors do not know which subjects are assigned to treatment and control groups, which

means that they were blinded to group assignment.

External Validity Externalvalidity isconcernedwiththe extent towhich study findingscanbegeneralized beyondthe

sample used in the study (Shadish et al., 2002). With the most serious threat, the findings would be

meaningful only for the group studied. To some extent, the significance of the study depends on the

number of types of people and situations to which the findings can be applied. Sometimes, the fac-

torsinfluencingexternalvalidityaresubtleandmaynotbereportedinresearchreports;however,the

researcher must be responsible for these factors. Generalization is usually narrower for asingle study

than for multiple replications of a study using different samples, perhaps from different populations

in different settings. Some of the threats to the ability to generalize the findings (external validity) in

terms of study design are described here and summarized in Table 8-1.

228 CHAPTER 8 Clarifying Quantitative Research Designs

Interaction of Selection and Treatment

Seeking subjects who are willing to participate in a study can be difficult, particularly if the study

requires extensive amounts of time or some other investment by subjects. If a large number of

persons approached to participate in a study decline to participate, the sample actually selected

will be limited in ways that might not be evident at first glance. Only the researcher knows the

subjects well. Subjects might be volunteers, “do-gooders”, or those with nothing better to do.

In this case, generalizing the findings to all members of a population, such as all nurses, all hos-

pitalized patients, or all persons experiencing diabetes, is not easy to justify.

The study must be planned to limit the investment demands on subjects and thereby improve

participation. For example, the researchers would select instruments that are valid and reliable but

have fewer items to decrease subject burden. The researcher must report the number of persons

who were approached and refused to participate in the study (refusal rate) so that those who exam-

ine the study can judge any threats to external validity. As the percentage of those who decline to

participate increases, external design validity decreases. Sufficient data need to be collected on the

subjects to allow the researcher to be familiar with the characteristics of subjects and, to the greatest

extent possible, the characteristics of those who decline to participate (see Chapter 9).

Interaction of Setting and Treatment Bias exists in regard to the types of settings and organizations that agree to participate in studies.

This bias has been particularly evident in nursing studies. For example, some hospitals welcome

nursing studies and encourage employed nurses to conduct studies. Others are resistant to the con-

duct of nursing research. These two types of hospitals may be different in important ways; thus

there might be an interaction of setting and treatment that limits the generalizability of the find-

ings. Researchers must consider this factor when making statements about the population to which

their findings can be generalized.

Interaction of History and Treatment The circumstances occurring when a study is conducted might influence the treatment, which

could affect the generalization of the findings. Logically, one can never generalize to the future;

however, replicating the study during various time periods strengthens the usefulness of findings

over time. In critically appraising studies, you need to consider the effects of nursing practice and

societal events that occur during the period of the reported findings.

ELEMENTS OF DESIGNS EXAMINING CAUSALITY

Quasi-experimental and experimental designs are implemented in studies to obtain an accurate

representation of cause and effect by the most efficient means. That is, the design should provide

the greatest amount of control, with the least error possible. The effects of some extraneous vari-

ables are controlled in a study by using specific sampling criteria, a structured independent variable

or intervention, and a highly controlled setting. Randomized controlled trials (RCTs) are also

designed to examine causality and are considered by some sources to be one of the strongest

designs to examine cause and effect (Hoare & Hoe, 2013; Schulz, Altman, & Moher, 2010). RCTs

are discussed later in this chapter. The essential elements of research to examine causality are:

• Random assignment of subjects to groups

• Precisely defined independent variable or intervention

• Researcher-controlled manipulation of the intervention

• Researcher control of the experimental situation and setting

229CHAPTER 8 Clarifying Quantitative Research Designs

• Inclusion of a control or comparison group in the study

• Clearly identified sampling criteria (see Chapter 9)

• Carefully measured dependent or outcome variables (see Chapter 10)

Examining Interventions in Nursing Studies In studies examining causality, investigators develop an intervention that is expected to result

in differences in post-test measures between the treatment and control or comparison groups.

An intervention might also be called a treatment or an independent variable in a study. Inter-

ventions may be physiological, psychosocial, educational, or a combination of these. The

therapeutic nursing intervention implemented in a nursing study needs to be carefully

designed, clearly described, and appropriately linked to the outcomes (dependent variables)

to be measured in the study. The intervention needs to be provided consistently to all subjects.

A published study needs to document intervention fidelity, which includes a detailed descrip-

tion of the essential elements of the intervention and the consistent implementation of the

intervention during the study (Morrison et al., 2009; Santacroce, Maccarelli & Grey, 2004).

Sometimes, researchers provide a table of the intervention content and/or the protocol used

to implement the intervention to each subject consistently. A research report also needs to indi-

cate who implemented the intervention and what training was conducted to ensure consistent

intervention implementation. Some studies document the monitoring of intervention fidelity

(completeness and consistency of the intervention implementation) during the conduct of the

study (Carpenter et al., 2013).

Kim, Chung, Park, and Kang (2012) implemented an aquarobic exercise program to deter-

mine its effects on the self-efficacy, pain, body weight, blood lipid levels, and depression of patients

with osteoarthritis. These researchers detailed the components of their aquarobic exercise program

(intervention) in a table in their published study. Table 8-2 identifies the categories, session com-

position, physical fitness factors, and exercise content for the exercise program to promote the

consistent and complete implementation of the intervention to each of the study subjects. Kim

and colleagues (2012, p. 183) indicated that “the aquarobic exercise program consisted of both

patient education and aquarobic exercise. A professor of exercise physiology, medical specialist

of sports medicine, professor of mental health nursing, professor of adult nursing, professor of

senior nursing, and public-health nurse assessed the validity of the aquarobic exercise program.”

The osteoarthritis patients were educated in the exercise program and led in the exercises by a

trained instructor to promote intervention fidelity in this study. The details of the design of this

quasi-experimental study are presented in the next section.

Experimental and Control or Comparison Groups The group of subjects who received the study intervention is referred to as the experimental or

treatment group. The group that is not exposed to the intervention is referred to as the control

or comparison group. Although control and comparison groups traditionally have received no

intervention, adherence to this expectation is not possible in many nursing studies. For example,

it would be unethical not to provide preoperative teaching to a patient. Furthermore, in many

studies, it is possible that just spending time with a patient or having a patient participate in activ-

ities that he or she considers beneficial may in itself cause an effect. Therefore the study often

includes a comparison group nursing action.

This nursing action is usually the standard care that the patient would receive if a study were not

being conducted. The researcher must describe in detail the standard care that the control or

230 CHAPTER 8 Clarifying Quantitative Research Designs

TABLE 8-2 CONTENT OF THE AQUAROBIC EXERCISE PROGRAM

CATEGORIES

SESSION

COMPOSITION

PHYSICAL

FITNESS

FACTORS EXERCISE CONTENT

Attendance

check

Warm-up

(10 min)

Thermal warm-up* Cardiopulmonary

endurance; upper

and lower muscle

strength

Bounce (front, back, side, twist), ankle reach,

twist, knee jogging, knee lift, ski scissors,

jumping jacks

Stretch General flexibility;

cardiopulmonary

endurance;

muscle strength;

cardiopulmonary

endurance;

general muscle

strength

Water pull, knee swing, buttock stretch, calf

stretch, pectoral stretch

Main exercise

(40 min)

Cardiopulmonary

warm-up; aerobic

exercises

Bounce, slow kick, kick and hold, kick and

twist, kick and tuck, ankle reach, mule kick;

cardiorespiratory workout (overload

exercise)—kick (front, twist, back, side), leg

curl, jumping jacks, ski, leap, jazz kick,

pendulum, wide step, slide step, step and

cross, rocking horse; finger, wrist, elbow,

arm, shoulder workout—changing direction

of palm, changing position of hand (front,

back and down), elbow extension and

flexion, raising water with both hands, water

press, deltoid muscle, pectoralis major,

trapezius exercise to use the shoulder joint;

toe, foot, ankle, lower legs, hip workout—

jogging (narrow, wide, land tempo), hopping

(knee swing, kick swing, jazz kick, can-can

kick, double kick, knee and back); jump,

jumping jack, ski, twist, log, tuck, hip click

Break time

(10 min)

Forward running with hands placed onto one

another’s shoulder, body swing holding

both hands, matching, running in line

Playing ball

Exercise

swimming bar

(called aqua

noodle or aqua

bong), made

with foam

Using exercise swimming bar

Jumping jacks, back lunge knee, side lunge

knee, lunge cross, ski (half water, land

tempo), cycling while holding bong, getting

on a swing, riding on bong placed beneath

armpits

Continued*Thermal warm-up is an exercise designed to elevate the body temperature and provide muscles with more oxygen to facilitate the release of synovial fluid in the joints.

Continued

231CHAPTER 8 Clarifying Quantitative Research Designs

comparison group receives so that the study can be adequately appraised. Because the quality of

this standard care is likely to vary considerably among subjects, variance in the control or com-

parison group is likely to be high and needs to be considered in the discussion of findings. Some

researchers provide the experimental group with both the intervention and standard care to con-

trol the effect of standard care in the study.

QUASI-EXPERIMENTAL DESIGNS

Use of a quasi-experimental design facilitates the search for knowledge and examination of cau-

sality in situations in which complete control is not possible. This type of design was developed to

control as many threats to validity (see Table 8-1) as possible in a situation in which some of the

components of true experimental design are lacking. Most studies with quasi-experimental designs

have samples that were not selected randomly and there is less control of the study intervention,

extraneous variables, and setting. Most quasi-experimental studies include a sample of

TABLE 8-2 CONTENT OF THE AQUAROBIC EXERCISE PROGRAM—cont’d

CATEGORIES

SESSION

COMPOSITION

PHYSICAL

FITNESS

FACTORS EXERCISE CONTENT

Muscle

conditioning

Abdominal muscle

strength;

endurance

Raising leg, lifting knee, side step; press,

punch, crunch, twist jump and jump kick,

cycling while holding bong; body twist with

arms circled behind back

Using ball—pressing and throwing ball,

cycling while holding ball, stretching while

holding and raising ball

Cool-down

(10 minutes)

Cardiopulmonary

cool-down

Reducing heart and

respiratory rate

Raising leg to knee, jump, raising arm over

shoulder; inhaling with shoulders up, and

exhaling with shoulders down

Abdominal

respiration and

stretch

General flexibility;

tension relaxation

Stretching calf, inner thigh, stretching front

thigh and hip; pulling upper arm across

chest and stretching shoulder; stretching

shoulder with upper arm behind the neck,

stretching neck, stretching hip joints,

drawing big circles with upper arm

Using bong—drawing a circle with one foot,

writing with toe, rotating ankle, stretching

the flank while holding bong

Using ball—holding a ball on the head and

stretching the flank, turning the trunk while

holding ball

Counseling and

experience

sharing

(20 min)

Share problems with the workout practice;

questions and answers about movements

that are difficult to perform; counseling

about problems raised

Share experiences

From Kim, I., Chung, S., Park, Y., & Kang, H. (2012). The effectiveness of an aquarobic exercise program for patients with

osteoarthritis. Applied Nursing Research, 25(3), p. 184.

232 CHAPTER 8 Clarifying Quantitative Research Designs

convenience, in which the subjects are included in the study because they are at the right place at

the right time (see Chapter 9). The subjects selected are then randomly assigned to receive the

experimental treatment or standard care. The group who receives standard care is usually referred

to as a comparison group versus a control group, who would receive no treatment or standard care

(Shadish et al., 2002). However, the terms control group and comparison group are frequently used

interchangeably in nursing studies.

In many studies, subjects from the original sample are randomly assigned to the experimental or

comparison group, which is an internal design validity strength. Occasionally, comparison and

treatment groups may evolve naturally. For example, groups may include subjects who choose

a treatment as the experimental group and subjects who choose not to receive a treatment as

the comparison group. These groups cannot be considered equivalent, because the subjects

who select to be in the comparison group probably differ in important ways from those who select

to be in the treatment group. For example, if researchers were implementing an intervention of an

exercise program to promote weight loss, the subjects should not be allowed to select whether they

are in the experimental group receiving the exercise program or the comparison group not receiv-

ing an exercise program. Subjects’ self-selecting to be in the experimental or comparison group is a

threat to the internal design validity of a study.

Pretest and Post-test Designs with Comparison Group Quasi-experimental study designs vary widely. The most frequently used design in social science

research is the untreated comparison group design, with pretest and post-test (Figure 8-9). With

this design, the researcher has a group of subjects who receive the experimental treatment (or inter-

vention) and a comparison group of subjects who receive standard care.

Another commonly used design is the post-test–only design with a comparison group, shown in

Figure 8-10. This design is used in situations in which a pretest is not possible. For example, if the

Measurement of dependent variable(s)

Manipulation of independent variable

Treatment—experimental group comparison group not treated or receives standard or routine care

Comparison group—not randomly selected

Approach to analysis: • Examine difference between comparison and experimental pretest • Examine difference between pretest and posttest • Examine difference between comparison and experimental posttest

Uncontrolled threats to validity: • Selection-maturation • Instrumentation • Differential statistical regression • Interaction of selection and history

Measurement of dependent variable(s)

Experimental group

Pretest Treatment Posttest

Nonequivalent comparison group

Pretest Posttest

FIG 8-9 Pretest and post-test design with a comparison group.

233CHAPTER 8 Clarifying Quantitative Research Designs

researcher is examining differences in the amount of pain a subject feels during a painful proce-

dure, and a nursing intervention is used to reduce pain for subjects in the experimental group, it

might not be possible (or meaningful) to pretest the amount of pain before the procedure. This

design incorporates a number of threats to validity because of the lack of a pretest. You can use the

algorithm shown in Figure 8-11 to determine the type of quasi-experimental study design used in a

published study. More details about specific designs identified in this algorithm are available from

other sources (Grove et al., 2013; Shadish et al., 2002).

Manipulation of independent

variable Measurement of

dependent variable(s)

TREATMENTExperimental group POSTTEST

Nonequivalent comparison group POSTTEST

Treatment—often ex post facto may not be well defined

Experimental group—those who receive the treatment and the posttest

Pretest—inferred—norms of measures of dependent variable(s) of population from which experimental group taken

Comparison group—not randomly selected—tend to be those who naturally in the situation do not receive the treatment

Approach to analysis: • comparison of posttest scores of experimental and comparison group • comparison of posttest scores with norms

Uncontrolled threats to validity: • no link between treatment and change • no pretest • selection

FIG 8-10 Post-test–only design with a comparison group.

? CRITICAL APPRAISAL GUIDELINES Quasi-experimental and Experimental Designs

When critically appraising the design of a quasi-experimental or experimental study, you need to address the

following questions:

1. Is the study design quasi-experimental or experimental? Review the algorithm in Figure 8-1 to determine the

type of study design.

2. Identify the specific type of quasi-experimental or experimental design used in the study. Review the algo-

rithm in Figure 8-11 for the types of quasi-experimental study designs and the algorithm in Figure 8-12 for the

types of experimental designs.

3. What were the strengths and threats to validity (statistical conclusion validity, internal validity, construct valid-

ity, and external validity) in the study (see Table 8-1)? Review the methods section and limitations identified in

the discussion section of the study report for ideas.

4. Which elements were controlled and which elements could have been controlled to improve the study

design? Review the sampling criteria, sample size, assignment of subjects to groups, and study setting.

234 CHAPTER 8 Clarifying Quantitative Research Designs

YesNo

YesNo

YesNoYesNo

Nonequivalent dependent variables design

Repeated treatment

design

Treatment replications?

YesNo

One-group posttest only

design

YesNo

Suggest reevaluating

design

YesNo

Suggest reevaluating

design

Comparison with

population values?

Yes

Pretest?

Comparison group?

No

Repeated measures?

One-group posttest only

design

YesNo

YesNo

Strategy for comparison?

Compare experimental and

comparison conditions

Compare treatment

and comparison conditions

Compare variables?

Interrupted time series

with nonequivalent

dependent variables

YesNo

Simple interrupted

time series

Interrupted time series

with removed treatment

Interrupted time series

with repeated

replications

Yes

Pretest?

No

Repeated measures?

Posttest only with

nonequivalent comparison

group

Compare treatments?

Interrupted time series

with nonequivalent comparison

group

Untreated comparison group with pretest and

posttest

Reversed-treatment nonequivalent

comparison group with pretest and posttest

FIG 8-11 Algorithm for determining the type of quasi-experimental design.

5. Was the study intervention described in detail? Was a protocol developed to ensure consistent or reliable

implementation of the intervention with each subject throughout the study? Did the study report indicate

who implemented the intervention? If more than one person implemented the treatment, how were they

trained to ensure consistency in the delivery of the treatment? Was intervention fidelity achieved in the study?

6. Were the study dependent variables measured with reliable and valid measurement methods?

235CHAPTER 8 Clarifying Quantitative Research Designs

RESEARCH EXAMPLE

Quasi-experimental Pretest–Post-test Design with a Comparison Group

Research Study Excerpt Kim and associates (2012) conducted a quasi-experimental study to examine the effect of an aquarobic exercise

program on the self-efficacy, pain, body weight, blood lipid levels, and depression of patients with osteoarthritis.

The intervention for this study was introduced in the previous section, and we encourage you to locate this article on

the website for this text and critically appraise the design of this study. The critical appraisal of this study was con-

ducted using the Guidelines for Critically Appraising Quasi-experimental and Experimental Designs. The key ele-

ments of the Kim and co-workers’ (2012) study design are presented in the following excerpt:

“A nonequivalent control group and a pre- and posttest quasi-experimental design were used. The inde-

pendent variables were thirty-six 60-minute sessions of an aquarobic exercise program three times a week.

The dependent variables were self-efficacy, pain, body weight, blood lipids, and depression level.. . . The

inclusion criteria for this study consisted of the following: (a) women, (b) 60 years and older, (c)

osteoarthritis.. . . The exclusion criteria were the following: (a) previous knee or hip joint replacement sur-

gery, (b) any other surgical procedure of the lower limbs in the previous 6 months, (c) rheumatoid arthritis,

(d) mental or physical disorders, and (e) participation in a similar intervention in the past.. . . A total of 80

patients were initially recruited and randomly assigned to either a control or an experimental group (40

patients in each).. . . The final number of participants was 35 in the experimental group and 35 in the control

group. . ..” (Kim et al., 2012, pp.182-183)

Instruments

“Self-efficacy is the attitude of self-confidence and the competency of oneself to continue the exercise

under any situation. A questionnaire consisting of 14 items on a 10-point Likert-type scale that measures

self-efficacy for patients with arthritis was previously developed. . . . Cronbach’s alpha in this study was

.90. . . . Pain was measured with a VAS [visual analog scale]. . . . Body weight was assessed using a body

composition analyzer. . . . Blood lipids (total cholesterol, triglycerides, and high density lipoproteins [HDLs])

were measured using enzymatic methods. . . Blood samples were sent for analysis immediately after collec-

tion” (Kim et al. 2012, p. 185). Depression was measured with the Zung Depression Scale that consists of 20

items (10 positive and 10 negative) with 4-point Liker-type scale. The Cronbach’s alpha found in this study

was .75.

Procedure

“Prior to the start of the study, we collected baseline (pretest) data that included. . .self-efficacy, pain, body

weight, blood lipid levels, and levels of depression from the experimental and control groups. The experimen-

tal group underwent an aquarobic exercise program for 12 weeks. Post-test data . . .were collected following

completion of the exercise program.” (Kim et al., 2012, p. 185).

Critical Appraisal Kim and colleagues (2012) clearly identified the quasi-experimental design used in their study, and this design was

appropriate to address the study purpose. The sample exclusion criteria were selected to control the effects of

extraneous variables, such as joint replacements or rheumatoid arthritis, on the study dependent or outcome

variables (internal validity strength). The initial sample was one of convenience (threat to internal and external

validity), and the researchers recommended conducting the study with a larger, random sample. The subjects were

randomly assigned to the experimental and control groups, with 40 subjects in each group (internal validity

strength). The attrition was 12.5% for each group, which is an internal design validity strength for a

12-week study.

The instruments used to measure the dependent variables—self-efficacy, pain, body weight, blood lipid levels, and

depression levels—were discussed in the study and were appropriate and reliable, adding to the statistical conclusion

and construct design validity of the study. However, the validity of the self-efficacy scale and Zung Depression Scale

236 CHAPTER 8 Clarifying Quantitative Research Designs

EXPERIMENTAL DESIGNS

A variety of experimental designs, some relatively simple and others very complex, have been

developed for studies focused on examining causality. In some cases, researchers may combine

characteristics of more than one design to meet the needs of their study. Names of designs vary

from one text to another. When reading and critically appraising a published study, determine

the author’s name for the design (some authors do not name the design used) and/or read the

description of the design to determine the type of design used in the study. Use the algorithm

shown in Figure 8-12 to determine the type of experimental design used in a published study. More

details about the specific designs identified in Figure 8-12 are available in other texts (Grove et al.,

2013; Shadish et al., 2002).

Classic Experimental Pretest and Post-test Designs with Experimental and Control Groups A common experimental design used in healthcare studies is the pretest–post-test design with

experimental and control groups (Campbell & Stanley, 1963; Shadish et al., 2002). This design

is shown in Figure 8-13; it is similar to the quasi-experimental design in Figure 8-9, except

that the experimental study is more tightly controlled in the areas of intervention, setting,

measurement, and/or extraneous variables, resulting in fewer threats to design validity. The

experimental design is stronger if the initial sample is randomly selected; however, most stud-

ies in nursing do not include a random sample but do randomly assign subjects to the exper-

imental and control groups. Most studies in nursing use the quasi-experimental design shown

in Figure 8-9 because of the inability to control selected extraneous and environmental

variables.

Multiple groups (both experimental and control) can be used to great advantage in experimen-

tal designs. For example, one control group might receive no treatment, another control group

might receive standard care, and another control group might receive a placebo or intervention

were not addressed, and more detail might have been provided on the accuracy of the physiological measures of

body weight and blood lipid levels.

The aquarobic exercise program was detailed in the published study (see Table 8-2) and was consistently imple-

mented, promoting the fidelity of the intervention and adding to the design statistical conclusion validity and

external validity. The setting for the exercises was highly controlled, which also adds to the external validity

of the design. The researchers noted that the study participants were recruited from a single public health center,

which limits the generalization of the findings. The design of the Kim et al. (2012) study was extremely strong and

demonstrated statistical conclusion, and internal, construct, and external validity with few threats to design

validity.

Implications for Practice Kim and associates (2012) found that the experimental group had significant improvement in self-efficacy, pain,

body weight, blood lipid levels, and depression levels when compared with the control group. The researchers

recommended the use of this intervention in patients with osteoarthritis. The QSEN implications are that this

exercise intervention for patients with osteoarthritis is supported by research. Nurses and students are encouraged

to provide this type of evidence-based exercise intervention to their patients with osteoarthritis.

237CHAPTER 8 Clarifying Quantitative Research Designs

YesNo

Solomon four-group

design

Factorial designs

YesNo

Examination of multiple causality?

Multivariate designs

YesNo

Examination of complex relationships

among variables in relation to treatment

Nested designs

YesNo

Multiple sites?

YesNo

YesNo

Pretest/posttest comparison or

control group design

Comparison group?

Repeated measures?

Posttest only comparison

group design

YesNo

Repeated measures design

Examine effects of confounding

variables?

Randomized clinical trials

Blocking?

Yes

Comparison of multiple levels of treatment

Randomized block design

No

FIG 8-12 Algorithm for determining the type of experimental design.

238 CHAPTER 8 Clarifying Quantitative Research Designs

with no effect like a sugar pill in a drug study. Each one of multiple experimental groups can receive

a variation of the treatment, such as a different frequency, intensity, or duration of nursing care

measures. For example, different frequency, intensity, or duration of massage treatments might be

implemented in a study to determine their effect(s) on patients’ muscle pain. These additions

greatly increase the generalizability of study findings when the sample is representative of the target

population and the sample size is strong.

Post-test–Only with Control Group Design The experimental post-test–only control group design is also frequently used in healthcare studies

when a pretest is not possible or appropriate. This design is similar to the design in Figure 8-13,

with the pretest omitted. The characteristics of the experimental and control groups are usually

examined at the start of the study to ensure that the groups are similar. The lack of a pretest does,

however, increase the potential for error that might affect the findings. Additional research is

recommended before generalization of findings. Ryu, Park, and Park (2012) conducted an exper-

imental study with post-test–only control group design that is presented here as an example.

Measurement of dependent variable(s)

Manipulation of independent variable

Treatment: Under control of researcher

Approach to analysis: • Comparison of pretest and posttest scores • Comparison of comparison and experimental groups • Comparison of pretest/posttest differences between samples

Uncontrolled threats to validity: • Testing • Instrumentation • Mortality • Restricted generalizability as control increases

Measurement of dependent variable(s)

Randomized experimental

group

Pretest Treatment Posttest

Randomized comparison or control group

Pretest Posttest

FIG 8-13 Pretest–post-test control group design.

RESEARCH EXAMPLE

Experimental Post-test–Only Control Group Design

Research Study Excerpt Ryuandco-workers(2012)conductedanexperimentalstudytoexaminetheeffectofsleep-inducingmusiconsleepin

persons who had undergone percutaneous transluminal coronary angiography (PTCA) in the cardiac care unit

(CCU). These researchers used a post-test–only control group design in their study because the patients were usually

only in the CCU 24 hours or less after their PTCA procedure. Ryu and colleagues collected data on the demographic Continued

239CHAPTER 8 Clarifying Quantitative Research Designs

RESEARCH EXAMPLE—cont’d

variables (gender, age, education, religion, marital status, and satisfaction on sleep) for the experimental and control

groups at the start of the study. They found no significant differences in demographic and sleeping characteristics

betweentheexperimentalandcontrolgroups.Thefollowingstudyexcerptincludeskeyelementsofthisstudy’sdesign:

“The inclusion criteria were�20 years of age, diagnosis of coronary artery disease, admittance to CCU after PTCA.. . . Exclusion criteria were use of ventilators; diagnosed with dementia, neurologic disease, or sensory

disorder; use of sleep-inducing drugs or sedative medications; and history of sleeping problems before admis-

sion to CCU.. . . The 60 participants were randomly assigned to experimental group or control group using a card

number.. . . During data collection, two subjects dropped out. One participant in the experimental group was

excluded for having taken a sleep-inducing drug. One participant in the control group was transferred to another

unit. Finally, 29 subjects constituted the experimental group and 29 formed the control group.. . .

The quantity of sleeping was counted as total number of minutes from the time of falling asleep to the

time of awakening the next morning. If a subject awoke for a short time during the night, the time of wake-

fulness was subtracted from the sleeping minutes.. . . Quality of sleeping was measured using the modified

Verran and Snyder-Halpern (VSH) sleeping scale. . .. Cronbach’s alpha value of the modified VSH in this study

was 0.83” (Ryu et al., 2012, pp. 730-731).

“The sleep-inducing music [developed by Park as part of a Master’s thesis] included Nature Sounds

(2 minutes 8 seconds), Delta Wave Control Music (5 minutes 21 seconds). . . and Nature Sounds (2 minutes

25 seconds). The MP3 music was supplied through earphones to the participants from 10:00-10:53 PM. If a

subject fell asleep with the music still in progress, the earphone was not removed intentionally until 5 AM the

next morning. Eye bandage CS-204 (CS Berea Korea) was also applied to the participants at 10 PM and was

removed at 5 AM. . . No music was offered to the control group participants, but ear plugs 370 Bilsom No. 303

were applied from 10 PM-5 AM the next morning. The same eye bandage used in the experimental group was

also applied to the control participants.” (Ryu et al., 2012, p. 731)

Critical Appraisal Ryu and colleagues (2012) identified their design as experimental in their study abstract but did not identify the

specific type of design as a post-test–only control group design. This design was appropriate for addressing the study

purpose and hypotheses. The sample exclusion criteria controlled possible extraneous variables, and the random

assignment of subjects to the experiment and control groups increased the internal and external validity of the study

design. The subject attrition was very low (one subject per group, for total of 3.3% for the study), and the reasons for

their dropping out of the study were documented and seemed usual (internal validity strength).

A trained data collector measured the dependent variable quantity of sleeping in a structured, consistent way. The

quality of sleeping variable was measured with a VSH sleeping scale that had established reliability in previous stud-

ies and strong reliability in this study, with Cronbach’s alpha¼0.83 (83% reliable and 17% error). More detail was needed about the validity of this scale and its ability to measure quality of sleeping. For the most part, quality instru-

ments were used in this study, adding to the statistical conclusion and construct validity of the study.

The experimental group received a structured sleep-inducing music intervention that was delivered consistently

using an MP3 player for each subject, which ensured intervention fidelity. Both groups of subjects received the stan-

dard care of eye bandages, and the control group was also provided with standard earplugs. The study was in the

CCU setting, so the researchers were able to control the environment of the subjects. The intervention fidelity and

controlled study setting strengthen the study’s external and statistical conclusion validity. The detailed control of the

intervention, setting, and data collection process are consistent with implementing an experimental study design.

This study’s design included several strengths and a few weaknesses, which increased the validity of the findings and

their potential usefulness for practice.

Implications for Practice Ryu and associates (2012) found that the sleep-inducing music intervention significantly improved the quantity and

qualityof sleepingfor the experimental groupover that of the control group. The researchersrecommended that offering

CCU patients sleep-inducing music might be an easy, cost-effective intervention for improving sleep for these patients.

240 CHAPTER 8 Clarifying Quantitative Research Designs

RANDOMIZED CONTROLLED TRIALS

Currently, in medicine and nursing, the randomized controlled trial (RCT) is noted to be the

strongest methodology for testing the effectiveness of a treatment because of the elements of

the design that limit the potential for bias. Subjects are randomized to the treatment and control

groups to reduce selection bias (Carpenter et al., 2013; Hoare & Hoe, 2013; Schulz et al., 2010). In

addition, blinding or withholding of study information from data collectors, participants, and

their healthcare providers can reduce the potential for bias. RCTs, when appropriately conducted,

are considered the gold standard for determining the effectiveness of healthcare interventions.

RCTs may be carried out in a single setting or in multiple geographic locations to increase sample

size and obtain a more representative sample.

The initial RCTs conducted in medicine demonstrated inconsistencies and biases. Conse-

quently, a panel of experts—clinical trial researchers, medical journal editors, epidemiologists,

and methodologists—developed guidelines to assess the quality of RCTs reports. This group ini-

tiated the Standardized Reporting of Trials (SORT) statement that was revised and became the

CONsolidated Standards for Reporting Trials (CONSORT). This current guideline includes a

checklist and flow diagram that might be used to develop, report, and critically appraise published

RCTs (CONSORT, 2012). Nurse researchers need to follow the CONSORT 2010 statement recom-

mendations in the conduct of RCTs and in their reporting (Schulz et al., 2010). You might use the

flow diagram in Figure 8-14 to critically appraise the RCTs reported in nursing journals. An RCT

needs to include the following elements:

1. The study was designed to be a definitive test of the hypothesis that the intervention caused the

defined dependent variables or outcomes.

2. The intervention is clearly described and its implementation is consistent to ensure interven-

tion fidelity (CONSORT, 2012; Santacroce et al., 2004; Schulz et al., 2010; Yamada, Stevens,

Sidani, Watt-Watson, & De Silva, 2010).

3. The study is conducted in a clinical setting, not in a laboratory.

4. The design meets the criteria of an experimental study (Schulz et al., 2010).

5. Subjects are drawn from a reference population through the use of clearly defined criteria.

Baseline states are comparable in all groups included in the study. Selected subjects are then

randomly assigned to treatment and comparison groups (see Figure 8-14)—thus, the term

randomized controlled trial (CONSORT, 2012; Schulz et al., 2010).

6. The study has high internal validity. The design is rigorous and involves a high level of control

of potential sources of bias that will rule out possible alternative causes of the effect (Shadish

et al., 2002). The design may include blinding to accomplish this purpose. With blinding the

patient, those providing care to the patient, and/or the data collectors are unaware of whether

the patient is in the experimental group or in the control group.

7. Dependent variables or outcomes are measured consistently with quality measurement methods

(Waltz et al., 2010).

8. The intervention is defined in sufficient detail so that clinical application can be achieved

(Schulz et al., 2010).

9. The subjects lost to follow-up are identified with their rationale for not continuing the study.

The attrition from the experimental and control groups needs to be addressed, as well as the

overall sample attrition.

10. The study has received external funding sufficient to allow a rigorous design with a sample size

adequate to provide a definitive test of the intervention.

241CHAPTER 8 Clarifying Quantitative Research Designs

CONSORT Statement 2010 Flow Diagram

Assessed for eligibility (n= )

Excluded (n= )

♦ Not meeting inclusion criteria (n= ) ♦ Declined to participate (n= ) ♦ Other reasons (n= )

Analyzed (n= ) ♦ Excluded from analysis (give reasons) (n= )

Lost to follow-up (give reasons) (n= )

Discontinued intervention (give reasons) (n= )

Allocated to intervention (n= ) ♦ Received allocated intervention (n= ) ♦ Did not receive allocated intervention (give reasons) (n= )

Lost to follow-up (give reasons) (n= )

Discontinued intervention (give reasons) (n= )

Allocated to intervention (n= ) ♦ Received allocated intervention (n= ) ♦ Did not receive allocated intervention (give reasons) (n= )

Analyzed (n= ) ♦ Excluded from analysis (give reasons) (n= )

A llo

ca tio

n A

n a ly

si s

F o llo

w -U

p

Randomized (n= )

E n ro

llm e n t

FIG 8-14 CONSORT 2010 statement showing a flow diagram of the progress through the phases of a parallel randomized trial of two groups (enrollment, intervention allocation, follow-up, and data analysis). (From CONSORT. [2012]. The CONSORT statement. Retrieved May 6, 2013 from http://www.consort-statement.org/consort-statement; and Schulz, K. F., Altman, D. G., & Moher, D. [2010]. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. Annals of Internal Medicine, 152[11], 726-733.)

RESEARCH EXAMPLE

Randomized Controlled Trial (RCT)

Research Study Excerpt Jones, Duffy, and Flanagan (2011) conducted a RCT to test the efficacy of a nurse-coached intervention (NCI) on the

outcomes of patients undergoing ambulatory arthroscopic surgery. The NCI was developed to improve the post-

operative experiences of patients and families following ambulatory surgery. This study was funded by the National

Institute of Nursing Research. The following study excerpt identifies the study hypothesis, design, and major

findings:

242 CHAPTER 8 Clarifying Quantitative Research Designs

INTRODUCTION TO MIXED-METHODS APPROACHES

There is controversy among nurse researchers about the relative validity of various approaches or

designs needed to generate knowledge for nursing practice. Designing quantitative experimental

studies with rigorous controls may provide strong external validity but sometimes have limited

internal validity. Qualitative studies may have strong internal validity but questionable external

validity. A single approach to measuring a concept may be inadequate to justify the claim that

it is a valid measure of a theoretical concept. Testing a single theory may leave the results open

to the challenge of rival hypotheses from other theories (Creswell, 2014).

As research methodologies continue to evolve, mixed-methods approaches offer investigators

the ability to use the strengths of qualitative and quantitative research designs. Mixed-methods

research is characterized as research that contains elements of both qualitative and quantitative

approaches (Creswell, 2014; Grove et al., 2013; Marshall & Rossman, 2011; Morse, 1991;

Myers & Haase, 1989).

“This study was conducted to test the hypothesis that ambulatory arthroscopic surgery patients who receive

a nurse-coached telephone intervention will have significantly less symptom distress and better functional

health status than a comparable group who receive usual practice.. . .

The study sample in this randomized controlled trial with repeated measures was 102 participants (52 in

the intervention group and 50 in the usual practice group) drawn from a large academic medical center in the

Northeast United States. Symptom distress was measured using the Symptom Distress Scale, and func-

tional health was measured using the Medical Outcomes Study 36-Item Short-Form Health Survey General

Health Perceptions and Mental Health subscales.” (Jones et al., 2011, p. 92)

Critical Appraisal Jones and co-workers (2011) detailed their study intervention and the steps taken by the researchers to promote

fidelity in the implementation of the NCI. The nurses were trained in the delivery of the NCI by the study team

using a video. Each nurse coach was provided with a packet of guidelines for management of the participants’

symptoms.

“The guidelines addressed common patient problems associated with postoperative recovery after arthros-

copy with general anesthesia (e.g., nausea, vomiting, pain, immobility). The guidelines contained five areas to

evaluate: (a) assessment (self-report), (b) current management of symptoms, (c) evaluation by the coach of

the adequacy of the intervention, (d) additional intervention strategies to address the presenting symptoms,

and (e) proposed outcome (self-report)” (Jones et al., 2011, p. 95).

The sample criteria were detailed to identify the target population. Once the patients consented to be in the study,

they were randomly assigned to the NCI group or the usual care group using the sealed envelope method (Maxwell &

Delaney, 2004). The steps of this study followed the steps outlined in the CONSORT flow diagram in Figure 8-14.

However, the sample size and group sizes were small for a RCT, and the study was implemented in only one setting,

decreasing the generalizability of the findings.

Implications for Practice Jones and colleagues (2011) found that the NCI delivered by telephone postoperatively to arthroscopic surgery

patients significantly reduced their symptom distress and improved their physical and mental health. The findings

for this study were consistent with previous research in this area and have potential use in practice. The NCI was

provided in a format that might be implemented in clinical settings. The QSEN implications are that the NCI is an

appropriate way for nurses to provide patient-centered care to individuals following arthroscopic surgery to

improve their recovery.

243CHAPTER 8 Clarifying Quantitative Research Designs

There has been debate about the philosophical underpinnings of mixed-methods research and

which paradigm best fits this method. It is recognized that all researchers bring assumptions to

their research, consciously or unconsciously, and investigators decide whether they are going to

view their study from a postpositivist (quantitative) or constructivist (qualitative) perspective

(Fawcett & Garity, 2009; Munhall, 2012).

Over the last few years, many researchers have departed from the idea that one paradigm or one

research strategy is right and have taken the perspective that the search for truth requires the use of

all available strategies. To capitalize on the representativeness and generalizability of quantitative

research and the in-depth, contextual nature of qualitative research, mixed methods are combined

in a single research study (Creswell, 2014). Because phenomena are complex, researchers are more

likely to capture the essence of the phenomenon by combining qualitative and quantitative

methods.

The idea of using mixed-methods approaches to conduct studies has a long history. More than

50 years ago, quantitative researchers Campbell and Fiske (1959) recommended mixed methods to

measure a psychological trait more accurately. This mixed methodology was later expanded into

what Denzin (1989) identified as “triangulation.” Denzin believed that combining multiple theo-

ries, methods, observers, and data sources can assist researchers in overcoming the intrinsic bias

that comes from single-theory, single-method, and single-observer studies. Triangulation evolved

to include using multiple data collection and analysis methods, multiple data sources, multiple

analyses, and multiple theories or perspectives. Today, the studies including both quantitative

and qualitative design strategies are identified as mixed-methods designs or approaches

(Creswell, 2014). More studies with mixed-methods designs have been appearing in nursing jour-

nals. You need to recognize studies with mixed-methods designs and be able to appraise the quan-

titative and qualitative aspects of these designs critically.

RESEARCH EXAMPLE

Mixed-Methods Approaches

Research Study Excerpt Piamjariyakul, Smith, Russell, Werkowitch, and Elyachar (2013) conducted a mixed-methods study to examine the

feasibility and effects of a telephone coaching program on family caregivers’ home management of family members

with heart failure (HF). The major elements of this study’s design are presented in the following excerpt.

Research Design

“This pilot study employed a mixed methods design. The measures of caregiver burden, confidence, and

preparedness were compared pre- and post-intervention. Also overall cost analysis was used to determine

the expenses for educational materials and the cost of the nurse’s time to administer the coaching program

[quantitative quasi-experimental single group pre-test and posttest design]. Focus group and content analysis

research methods were used to evaluate the feasibility and helpfulness of the program [exploratory-

descriptive qualitative design]. Caregivers in this study were recruited from a group of HF patients receiving

care at a large Midwestern University Medical Center who were recently hospitalized due to HF exacerbation

[sample of convenience]. . . . All 12 family caregivers completed baseline data, and 10 subjects completed the

four-session program. Two caregivers completed only the first weekly session (one was too ill and the other

was too busy to continue).” (Piamjariyakul et al., 2013, pp. 33-34)

Caregiver Telephone Heart Failure Home Management Coaching Program [intervention]

“The coaching program for family caregivers was nurse-administered and conducted in four telephone ses-

sions. The content in the program and the need for the four coaching sessions was based on previous study

244 CHAPTER 8 Clarifying Quantitative Research Designs

K E Y C O N C E P T S

• A research design is a blueprint for conducting a quantitative study that maximizes control over

factors that could interfere with the validity of the findings.

• Four common types of quantitative designs are used in nursing—descriptive, correlational,

quasi-experimental, and experimental.

• Descriptive and correlational designs are conducted to describe and examine relationships

among variables. These types of designs are also called nonexperimental designs.

• Cross-sectional design involves examining a group of subjects simultaneously in various stages

of development, levels of educational, severity of illness, or stages of recovery to describe

changes in a phenomenon across stages.

• Longitudinal design involves collecting data from the same subjects at different points in time

and might also be referred to as repeated measures.

results, the American Heart Association HF national clinical guidelines, and the Heart Failure Society of

America (HFSA) information for family and friends.. . . The content was presented in a detailed table.. . .

For fidelity of the intervention implementation, a 2-hour training session. . .was provided for the 5 nurse inter-

ventionists” (Piamjariyakul et al., 2013, p. 34)

“Coaching program cost data was collected for all costs related to implementation of the program.. . . All

nurse interventionists shared their experiences in a focus group that was held after delivery of the coaching

program.” (Piamjariyakul et al., 2013, p. 36)

Critical Appraisal Piamjariyakul and associates (2013) clearly described their study as a mixed-methods design. The major focus of this

study was the development and evaluation of the telephone HF home management coaching program intervention

that was tested using a quasi-experimental, pretest–post-test, one-group design. This is a weak design that includes

no control group for comparison of study outcomes but might be considered acceptable for this pilot study focused

on intervention development. The qualitative part of the design included conducting a focus group with the nurses

who delivered the coaching intervention and doing content analysis of the focus group transcript. The researchers

might have provided more detail on the qualitative part of this design.

The subjects were selected with a sample of convenience, and the sample size was small (12 subjects, with a 15%

attrition to a final sample of 10). However, the researchers did indicate that this was a pilot study, and they recom-

mended the coaching program should be further tested with a larger sample. The HF home management coaching

program was presented in great detail. The content of the intervention was presented in a table in the research report

and was based on previous research and national evidence-based guidelines. The implementation of the interven-

tion with trained nurse interventionists ensured the fidelity of the intervention. The measurement methods (Care-

giving Burden Scale, confidence in providing HF care scale, and preparedness scale) were briefly described, but more

detail is needed about the scales’ reliability and validity.

Implications for Practice Piamjariyakul and co-workers (2013) found that the caregiver burden scores were significantly reduced by the

implementation of the HF home management coaching program, and the confidence and preparedness for HF

home management scores improved 3 months after the intervention. The qualitative part of the study described

the coaching program as feasible to implement and helpful to the caregivers. This study provided a quality HF home

management coaching program intervention, but more research is needed to determine the effectiveness of this

intervention for clinical practice (Brown, 2014; Craig & Smyth, 2012).

245CHAPTER 8 Clarifying Quantitative Research Designs

• Correlational designs are of three different types: (1) descriptive correlational, in which the

researcher can seek to describe a relationship; (2) predictive correlational, in which the

researcher can predict relationships among variables; and (3) the model testing design, in which

all the relationships proposed by a theory are tested simultaneously.

• Elements central to the study design include the presence or absence of a treatment, number of

groups in the sample, number and timing of measurements to be performed, method of sam-

pling, time frame for data collection, planned comparisons, and control of extraneous variables.

• The concepts important to examining causality include multicausality, probability, bias, con-

trol, and manipulation.

• Study validity is a measure of the truth or accuracy of the findings obtained from a study. Four

types of validity are covered in this text—statistical conclusion validity, internal validity, con-

struct validity, and external validity.

• The essential elements of experimental research are (1) the random assignment of subjects to

groups; (2) the researcher’s manipulation of the independent variable; and (3) the researcher’s

control of the experimental situation and setting, including a control or comparison group.

• Interventions or treatments are implemented in quasi-experimental and experimental studies

to determine their effect on selected dependent variables. Interventions may be physiological,

psychosocial, education, or a combination of these.

• Critically appraising a design involves examining the study setting, sample, intervention or

treatment, measurement of dependent variables, and data collection procedures.

• Randomized controlled trial (RCT) design is noted to be the strongest methodology for testing

the effectiveness of an intervention because of the elements of the design that limit the potential

for bias.

• As research methodologies continue to evolve in nursing, mixed-methods approaches are being

conducted to use the strengths of both qualitative and quantitative research designs.

REFERENCES

Battistelli, A., Portoghese, I., Galletta, M., & Pohl, S.

(2013). Beyond the tradition: Test of an integrative

conceptual model on nurse turnover. International

Nursing Review, 60(1), 103–111.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Buet, A., Cohen, B., Marine, M., Scully, F., Alper, P.,

Simpser, E., et al. (2013). Hand hygiene opportunities

in pediatric extended care facilities. Journal of Pediatric

Nursing, 28(1), 72–76.

Burns, K., Murrock, C. J., & Graor, C. H. (2012). Body

mass index and injury severity in adolescent males.

Journal of Pediatric Nursing, 27(5), 508–513.

Campbell, D. T., & Fiske, D. W. (1959). Convergent and

discriminate validation by the multitrait-multimethod

matrix. Psychological Bulletin, 56(2), 81–105.

Campbell, D. T., & Stanley, J. C. (1963). Experimental and

quasi-experimental designs for research. Chicago: Rand

McNally.

Carpenter, J. S., Burns, D. S., Wu, J., Yu, M., Ryker, K.,

Tallman, E., et al. (2013). Methods: Strategies used

and data obtained during treatment fidelity

monitoring. Nursing Research, 62(1), 59–65.

Cohen, J. (1988). Statistical power analysis for the

behavioral sciences (2nd ed.). New York: Academic

Press.

CONSORT, (2012). The CONSORT statement. Retrieved

May 6, 2013 from, http://www.consort-statement.org/

consort-statement.

Coyle, M. K. (2012). Depressive symptoms after a

myocardial infarction and self-care. Archives of

Psychiatric Nursing, 26(2), 127–134.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh: Churchill

Livingstone Elsevier.

Creswell, J. W. (2014). Research design: Qualitative,

quantitative and mixed methods approaches (4th ed.).

Thousand Oaks, CA: Sage.

246 CHAPTER 8 Clarifying Quantitative Research Designs

Denzin, N. K. (1989). The research act: A theoretical

introduction to sociological methods (3rd ed.).

New York: McGraw-Hill.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia: F. A.

Davis.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis: Elsevier Saunders.

Hoare, Z., & Hoe, J. (2013). Understanding quantitative

research: Part 2. Nursing Standard, 27(18), 48–55.

Hoe, J., & Hoare, Z. (2012). Understanding quantitative

research: Part 1. Nursing Standard, 27(15–17), 52–57.

Jones, D., Duffy, M. E., & Flanagan, J. (2011). Randomized

clinical trial testing efficacy of a nurse-coached

intervention in arthroscopy patients. Nursing Research,

60(2), 92–99.

Kerlinger, F. N., & Lee, H. B. (2000). Foundations of

behavioral research (4th ed.). Fort Worth, TX: Harcourt

College Publishers.

Kim, I., Chung, S., Park, Y., & Kang, H. (2012). The

effectiveness of an aquarobic exercise program for

patients with osteoarthritis. Applied Nursing Research,

25(3), 181–189.

Maloni, J. A., Przeworski, A., & Damato, E. G. (2013). Web

recruitment and Internet use and preferences reported

by women with postpartum depression after pregnancy

complications. Archives of Psychiatric Nursing, 27(2),

90–95.

Marshall, C., & Rossman, G. B. (2011). Designing

qualitative research (5th ed.). Thousand Oaks, CA:

Sage.

Maxwell, S. E., & Delaney, H. D. (2004). Designing

experiments and analyzing data: A model comparison

perspective (2nd ed.). Mahway, NJ: Lawrence Erlbaum

Associates.

Morrison, D. M., Hoppe, M. J., Gillmore, M. R., Kluver, C.,

Higa, D., & Wells, E. A. (2009). Replicating an

intervention: The tension between fidelity and

adaptation. AIDS Education and Prevention, 21(2),

128–140.

Morse, J. M. (1991). Approaches to qualitative-

quantitative methodological triangulation. Nursing

Research, 40(1), 120–123.

Munhall, P. L. (2012). Nursing research: A qualitative

perspective (5th ed.). Sudbury, MA: Jones & Bartlett.

Myers, S. T., & Haase, J. E. (1989). Guidelines for

integration of quantitative and qualitative approaches.

Nursing Research, 38(5), 299–301.

Piamjariyakul, U., Smith, C. E., Russell, C.,

Werkowitch, M., & Elyachar, A. (2013). The feasibility

of a telephone coaching program on heart failure home

management for family caregivers. Heart & Lung,

42(1), 32–39.

Quality and Safety Education for Nurses (QSEN), (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved February 11, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas/.

Ryu, M., Park, J. S., & Park, H. (2012). Effect of

sleep-inducing music on sleep in persons with percu-

taneous transluminal coronary angiography in the

cardiac care unit. Journal of Clinical Nursing, 21(5/6),

728–735.

Santacroce, S. J., Maccarelli, L. M., & Grey, M. (2004).

Methods: Intervention fidelity. Nursing Research, 53(1),

63–66.

Schulz, K. F., Altman, D. G., & Moher, D. (2010).

CONSORT 2010 statement: Updated guidelines for

reporting parallel group randomized trials. Annals of

Internal Medicine, 152(11), 726–733.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002).

Experimental and quasi-experimental designs for

generalized causal inference. Chicago: Rand McNally.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010).

Measurement in nursing and health research (4th ed.).

New York: Springer.

World Health Organization (WHO), (2009). Guidelines for

hand hygiene in health care. Retrieved May 6, 2013

from, http://whqlibdoc.who.int/publications/2009/

9789241597906_eng.pdf.

Yamada, J., Stevens, B., Sidani, S., Watt-Watson, J., & De

Silva, N. (2010). Content validity of a process

evaluation checklist to measure intervention

implementation fidelity of the EPIC Intervention.

Worldviews of Evidence-Based Nursing, 7(3), 158–164.

247CHAPTER 8 Clarifying Quantitative Research Designs

C H A P T E R

9 Examining Populations and Samples in Research

C H A P T E R OV E R V I E W

Understanding Sampling Concepts, 249

Populations and Elements, 250

Sampling or Eligibility Criteria, 251

Representativeness of a Sample in Quantitative

and Outcomes Research, 252

Random and Systematic Variation of Subjects’

Values, 253

Acceptance and Refusal Rates in Studies, 253

Sample Attrition and Retention Rates in

Studies, 253

Sampling Frames, 254

Sampling Methods or Plans, 255

Probability Sampling Methods, 257

Simple Random Sampling, 259

Stratified Random Sampling, 260

Cluster Sampling, 261

Systematic Sampling, 262

Nonprobability Sampling Methods Commonly

Used in Quantitative Research, 263

Convenience Sampling, 264

Quota Sampling, 265

Sample Size in Quantitative Studies, 266

Effect Size, 267

Types of Quantitative Studies, 267

Number of Variables, 267

Measurement Sensitivity, 268

Data Analysis Techniques, 268

Sampling in Qualitative Research, 270

Purposeful or Purposive Sampling, 270

Network Sampling, 271

Theoretical Sampling, 273

Sample Size in Qualitative Studies, 274

Scope of the Study, 274

Nature of the Topic, 274

Quality of the Information, 275

Study Design, 275

Research Settings, 276

Natural Setting, 277

Partially Controlled Setting, 277

Highly Controlled Setting, 278

Key Concepts, 278

References, 279

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Describe sampling theory, including the concepts

of population, target population, sampling

criteria, sampling frame, subject or participant,

sampling plan, sample, representativeness,

sampling error, and systematic bias.

2. Critically appraise the sampling criteria

(inclusion and exclusion criteria) in published

studies.

3. Identify the specific type of probability and

nonprobability sampling methods used in

published quantitative, qualitative, and

outcomes studies.

4. Describe the elements of power analysis used to

determine sample size in selected studies.

5. Critically appraise the sample size of quantitative

and qualitative studies.

248

6. Critically appraise the sampling processes used in

quantitative, qualitative, and outcomes studies.

7. Critically appraise the settings used in

quantitative, qualitative, and outcomes studies.

K E Y T E R M S

Acceptance rate, p. 253

Accessible population, p. 250

Cluster sampling, p. 261

Convenience sampling, p. 264

Effect size, p. 267

Elements, p. 250

Exclusion sampling criteria,

p. 251

Generalization, p. 250

Heterogeneous, p. 251

Highly controlled setting, p. 278

Homogeneous, p. 251

Inclusion sampling criteria,

p. 251

Intraproject sampling, p. 274

Natural (or field) setting, p. 277

Network sampling, p. 271

Nonprobability sampling, p. 263

Partially controlled setting,

p. 277

Participants, p. 250

Population, p. 250

Power, p. 266

Power analysis, p. 266

Probability sampling, p. 257

Purposeful or purposive

sampling, p. 270

Quota sampling, p. 265

Random sampling, p. 255

Random variation, p. 252

Refusal rate, p. 253

Representativeness, p. 252

Research setting, p. 276

Sample, p. 249

Sample attrition, p. 253

Sample retention, p. 254

Sample size, p. 266

Sampling, p. 249

Sampling frame, p. 255

Sampling method or plan, p. 255

Sampling or eligibility criteria,

p. 251

Saturation, p. 274

Simple random sampling, p. 259

Stratified random sampling,

p. 260

Subjects, p. 250

Systematic sampling, p. 262

Systematic variation, p. 252

Target population, p. 250

Theoretical sampling, p. 273

Verification, p. 274

Students often enter the field of research with preconceived notions about samples and sampling

methods. Many of these notions come from exposure to television advertisements, public opinion

polls, and newspaper reports of research findings. A television spokesperson boasts that four of five

doctors recommend a particular pain medication, a newscaster announces that John Jones will win

the senate election by a margin of 10%, and a newspaper reporter writes that research has shown

that aggressive treatment of hypertension to maintain a blood pressure of 120/80 mm Hg or lower

significantly reduces the risk for coronary artery disease and stroke.

Alltheseexamplesincludeasamplingtechniqueormethod.Someoftheoutcomesfromthesesam-

pling methods are more valid than others, based on the sampling method used and the sample size

achieved.Whencriticallyappraisingastudy,youneedtoexaminethesamplingprocessanddetermine

its quality. The sampling process is usually described in the methods section of a published research

report. This chapter was developed to assist you in understanding and critically appraising the sam-

pling processes implemented in quantitative, qualitative, and outcomes studies. Initially, the concepts

of sampling theory are introduced, including sampling criteria, sampling frame, and representative-

ness of a sample. The nonprobability and probability sampling methods and sample sizes for quan-

titative and qualitative studies are detailed. The chapter concludes with a discussion of the natural,

partially controlled, and highly controlled settings used in conducting research.

UNDERSTANDING SAMPLING CONCEPTS

Sampling involves selecting a group of people, events, objects, or other elements with which to

conduct a study. A sampling method or plan defines the selection process, and the sample defines

the selected group of people (or elements). A sample selected in a study should represent an

249CHAPTER 9 Examining Populations and Samples in Research

identified population of people. The population might be all people who have diabetes, all patients

who have had abdominal surgery, or all persons who receive care from a registered nurse. In most

cases, however, it would be impossible for researchers to study an entire population. Sampling the-

ory was developed to determine the most effective way to acquire a sample that accurately reflects

the population under study. Key concepts of sampling theory include populations, target popu-

lation, sampling or eligibility criteria, accessible population, elements, representativeness, sam-

pling frames, and sampling methods or plans. The following sections describe these concepts

and include relevant examples from published studies.

Populations and Elements The population is a particular group of individuals or elements, such as people with type 2 dia-

betes, who are the focus of the research. The target population is the entire set of individuals or

elements who meet the sampling criteria (defined in the next section), such as female, 18 years of

age or older, new diagnosis of type 2 diabetes confirmed by the medical record, and not on insulin.

Figure 9-1 demonstrates the link of the population, target population, and accessible population in

a study. An accessible population is the portion of the target population to which the researcher

has reasonable access. The accessible population might include elements within a country, state,

city, hospital, nursing unit, or primary care clinic, such as the individuals with diabetes who were

provided care in a primary care clinic in Arlington, Texas. Researchers obtain the sample from the

accessible population by using a particular sampling method or plan, such as simple random sam-

pling. The individual units of the population and sample are called elements. An element can be a

person, event, object, or any other single unit of study. When elements are persons, they are

referred to as participants or subjects (see Figure 9-1). Quantitative and outcomes researchers refer

to the people they study as subjects or participants. Qualitative researchers refer to the individuals

they study as participants.

Generalization extends the findings from the sample under study to the larger population. In

quantitative and outcomes studies, researchers obtain a sample from the accessible population

with the goal of generalizing the findings from the sample to the accessible population and then,

more abstractly, to the target population (see Figure 9-1). The quality of the study and consistency

of the study’s findings with the findings from previous research in this area influence the extent of

the generalization. If a study is of high quality, with findings consistent with previous research,

Population Target Population (Determined by Sampling Criteria)

Accessible Population (Available to the researcher)

Sample (Selected with Sampling Plan or Method)

Study Element: Subject or Participant

FIG 9-1 Linking population, sample, and elements in a study.

250 CHAPTER 9 Examining Populations and Samples in Research

then researchers can be more confident in generalizing their findings to the target population. For

example, the findings from the study of female patients with a new diagnosis of type 2 diabetes in a

primary care clinic in Arlington, Texas, may be generalized to the target population of women with

type 2 diabetes managed in primary care clinics. With this information, you can decide whether it

is appropriate to use this evidence in caring for the same type of patients in your practice, with the

goal of moving toward evidence-based practice (EBP; Brown, 2014; Melnyk & Fineout-

Overholt, 2011).

Sampling or Eligibility Criteria Sampling or eligibility criteria include the list of characteristics essential for eligibility or mem-

bership in the target population. For example, researchers may choose to study the effect of pre-

operative teaching about early ambulation on the outcome of length of hospital stay for adults

having knee joint replacement surgery. In this study, the sampling criteria may include (1) age

of at least 18 years of age or older (adults), (2) able to speak and read English, (3) surgical replace-

ment of one knee joint, (4) no history of previous joint replacement surgery, (5) no diagnosis of

dementia, and (6) no debilitating chronic muscle diseases. The sample is selected from the acces-

sible population that meets these sampling criteria. Sampling criteria for a study may consist of

inclusion or exclusion sampling criteria, or both. Inclusion sampling criteria are the character-

istics that the subject or element must possess to be part of the target population. In the example,

the inclusion criteria are age 18 years of age or older, able to speak and read English, and surgical

replacement of one knee joint. Exclusion sampling criteria are those characteristics that can cause

a person or element to be excluded from the target population. For example, any subjects with a

history of previous joint replacement surgery, diagnosis of dementia, and diagnosis of a debilitat-

ing chronic muscle disease were excluded from the preoperative teaching study. Researchers should

state a sample criterion only once and should not include it as both an inclusion and exclusion

criterion. Thus, researchers should not have an inclusion criterion of no diagnosis of dementia

and an exclusion criterion of diagnosis of dementia.

When the quantitative or outcomes study is completed, the findings are often generalized from

the sample to the target population that meets the sampling criteria (Fawcett & Garity, 2009).

Researchers may narrowly define the sampling criteria to make the sample as homogeneous

(or similar) as possible to control for extraneous variables. Conversely, the researcher may broadly

define the criteria to ensure that the study sample is heterogeneous, with a broad range of values or

scores on the variables being studied. If the sampling criteria are too narrow and restrictive,

researchers may have difficulty obtaining an adequately sized sample from the accessible popula-

tion, which can limit the generalization of findings.

In discussing the generalization of quantitative study findings in a published research report,

investigators sometimes attempt to generalize beyond the sampling criteria. Using the example of

the early ambulation preoperative teaching study, the sample may need to be limited to subjects

who speak and read English because the preoperative teaching is in English and one of the mea-

surement instruments requires that subjects be able to read English. However, the researchers may

believe that the findings can be generalized to non–English-speaking persons. When reading stud-

ies, you need to consider carefully the implications of using these findings with a non–English-

speaking population. Perhaps non–English-speaking persons, because they come from another

culture, do not respond to the teaching in the same way as that observed in the study population.

When critically appraising a study, examine the sample inclusion and exclusion criteria, and deter-

mine whether the generalization of the study findings is appropriate based on the study sampling

criteria. (Chapter 11 provides more detail on generalizing findings from studies.)

251CHAPTER 9 Examining Populations and Samples in Research

REPRESENTATIVENESS OF A SAMPLE IN QUANTITATIVE AND OUTCOMES RESEARCH

Representativeness means that the sample, accessible population, and target population are alike

in as many ways as possible (see Figure 9-1). In quantitative and outcomes research, you need to

evaluate representativeness in terms of the setting, characteristics of the subjects, and distribution

of values on variables measured in the study. Persons seeking care in a particular setting may be

different from those who seek care for the same problem in other settings or those who choose to

use self-care to manage their problems. Studies conducted in private hospitals usually exclude low-

income patients. Other settings may exclude older adults or those with less education. People who

do not have access to care are usually excluded from studies. Subjects in research centers and the

care that they receive are different from patients and the care that they receive in community hos-

pitals, public hospitals, veterans’ hospitals, or rural hospitals. People living in rural settings may

respond differently to a health situation from those who live in urban settings. Thus the setting

identified in published studies does influence the representativeness of the sample. Researchers

who gather data from subjects across a variety of settings have a more representative sample of

the target population than those limiting the study to a single setting.

A sample must be representative in terms of characteristics such as age, gender,ethnicity, income,

and education, which often influence study variables. These are examples of demographic or attri-

bute variables that might be selected by researchers for examination in their study. Researchers

analyze data collected on the demographic variables to produce the sample characteristics—

characteristics used to provide a picture of the sample. These sample characteristics must be

reasonably representative of the characteristics of the population. If the study includes groups,

the subjects in the groups must have comparable demographic characteristics (see Chapter 5 for

more details on demographic variables and sample characteristics).

Studies that obtain data from large databases have more representative samples. For example,

Monroe, Kenaga, Dietrich, Carter, and Cowan (2013) examined the prevalence of employed nurses

enrolled in substance use monitoring programs by examining data from the National Council of

State Boards of Nursing (NCSBN) 2010 Survey of Regulatory Boards Disciplinary Actions on

Nurses. This NCSBN survey included the United States and its territories and found that

17,085 (0.51%) of the employed nurses were enrolled in substance use monitoring programs. This

study examined data from multiple sites (United States and its territories) and included a large

national population of nurses (all employed nurses), resulting in a representative sample.

Random and Systematic Variation of Subjects’ Values Measurement values also need to be representative. Measurement values in a study often vary ran-

domly among subjects. Random variation is the expected difference in values that occurs when

different subjects from the same sample are examined. The difference is random because some

values will be higher and others lower than the average (mean) population value. As sample size

increases, random variation decreases, improving representativeness.

Systematic variation, or systematic bias—a serious concern in sampling—is a consequence of

selecting subjects whose measurement values differ in some specific way from those of the pop-

ulation. This difference usually is expressed as a difference in the average (or mean) values between

the sample and population. Because the subjects have something in common, their values tend to

be similar to those of others in the sample but different in some way from those of the population

as a whole. These values do not vary randomly around the population mean. Most of the variation

from the mean is in the same direction; it is systematic. Thus the sample mean may be higher than

or lower than the mean of the target population. Increasing the sample size has no effect on

252 CHAPTER 9 Examining Populations and Samples in Research

systematic variation. For example, if all the subjects in a study examining some type of knowledge

level have an intelligence quotient (IQ) above 120, then all their test scores in the study are likely to

be higher than those of the population mean, which includes people with a wide variation in IQ

scores (but with a mean IQ of 100). The IQs of the subjects will introduce a systematic bias. When

systematic bias occurs in quasi-experimental or experimental studies, it can lead the researcher to

conclude that the treatment has made a difference, when in actuality the values would have been

different, even without the treatment.

Acceptance and Refusal Rates in Studies The probability of systematic variation increases when the sampling process is not random. Even in

a random sample, however, systematic variation can occur when a large number of the potential

subjects declines participation. As the number of subjects declining participation increases, the

possibility of a systematic bias in the study becomes greater. In published studies, researchers

may identify a refusal rate, which is the percentage of subjects who declined to participate in

the study, and the subjects’ reasons for not participating (Grove, Burns, & Gray, 2013). The for-

mula for calculating the refusal rate in a study is as follows:

Refusal rate ¼ Number refusing participationð � number meeting sampling criteria approachedÞ � 100%

For example, if 80 potential subjects meeting sampling criteria are approached to participate in

the hypothetical study about the effects of early ambulation preoperative teaching on length of

hospital stay, and 4 patients refuse, then the refusal rate would be:

Refusal rate ¼ 4 � 80ð Þ � 100% ¼ 0:5 � 100% ¼ 5% Other studies record an acceptance rate, which is the percentage of subjects meeting sampling

criteria consenting to participate in a study. However, researchers will report the refusal or accep-

tance rate, but not both. The formula for calculating the acceptance rate in a study is as follows:

Acceptance rate ¼ Number accepting participationð � number meeting sampling criteria approachedÞ � 100%

In the hypothetical preoperative teaching study, 4 of 80 potential subjects refused to participate—

so 80�4¼76 accepted. Plugging the following numbers into the stated formula gives: Acceptance rate ¼ 76 � 80ð Þ � 100% ¼ 0:95 � 100% ¼ 95%

You can also calculate the acceptance and refusal rates as follows:

Acceptance rate ¼ 100% � refusal rate Or:

Refusal rate ¼ 100% � acceptance rate In this example, the acceptance rate was 100%�5% (refusal rate)¼95%, which is high or

strong. In studies with a high acceptance rate or a low refusal rate reported, the chance for system-

atic variation is less, and the sample is more likely to be representative of the target population.

Researchers usually report the refusal rate, and it is best to provide rationales for the individuals

refusing to participate.

Sample Attrition and Retention Rates in Studies Systematic variation also may occur in studies with high sample attrition. Sample attrition is the

withdrawal or loss of subjects from a study that can be expressed as a number of subjects

253CHAPTER 9 Examining Populations and Samples in Research

withdrawing or a percentage. The percentage is the sample attrition rate and it is best if researchers

include both the number of subjects withdrawing and the attrition rate. The formula for calculat-

ing the sample attrition rate in a study is as follows:

Sample attrition rate ¼ Number of subjects withdrawing from a studyð � sample size of studyÞ � 100%

For example, in the hypothetical study of preoperative teaching, 31 subjects—12 from the treat-

ment group and 19 from the comparison group—withdraw, for various reasons. Loss of 31 sub-

jects means a 41% attrition rate:

Sample attrition rate ¼ 31 � 76ð Þ � 100% ¼ 0:418 � 100% ¼ 40:8% ¼ 41% In this example, the overall sample attrition rate was considerable (41%), and the rates differed for

the two groups to which the subjects were assigned. You can also calculate the attrition rates for the

groups. If the two groups were equal at the start of the study and each included 38 subjects, then the

attrition rate for the treatment group was (12 � 38)�100%¼0.316�100%¼31.6%¼32%. The attrition for the comparison group was (19 � 38) x 100%¼0.5�100%¼50%. Systematic variation isgreatestwhenalargenumberofsubjectswithdrawfromthestudybeforedatacollectioniscompleted

or when a large number of subjects withdraw from one group but not the other(s) in the study. In

studies involving a treatment, subjects in the comparison group who do not receive the treatment

may be more likely to withdraw from the study. However, sometimes the attrition is higher for the

treatment group if the intervention is complex and/or time-consuming (Kerlinger & Lee, 2000). In

theearlyambulationpreoperativeteachingexample,thereisastrongpotentialforsystematicvariation

becausethesampleattritionratewaslarge(41%)andtheattritionrateinthecomparisongroup(50%)

was larger than the attrition rate in the treatment group (32%). The increased potential for systematic

variation results in a sample that is less representative of the target population.

The opposite of sample attrition is the sample retention, which is the number of subjects who

remain in and complete a study. You can calculate the sample retention rate in two ways:

Sample retention rate ¼ Number of subjects completing the study � sample sizeð Þ � 100%

Or:

Sample retention rate ¼ 100% � sample attrition rate In the example, early ambulation preoperative teaching study, 45 subjects were retained in the

study that had an original sample of 76 subjects:

Sample retention rate ¼ 45 � 76ð Þ � 100% ¼ 0:59 � 100% ¼ 59:2% ¼ 59% Or:

Sample retention rate ¼ 100% � 41% ¼ 59% The higher the retention rate, the more representative the sample is of the target population and

the more likely the study results are an accurate reflection of reality. Often, researchers will identify

the attrition rate or retention rate, but not both. It is best to provide a rate in addition to the num-

ber of subjects withdrawing from a study, as well as the subjects’ reasons for withdrawing.

Sampling Frames From a sampling theory perspective, each person or element in the population should have an

opportunity to be selected for the sample. One method of providing this opportunity is referred

254 CHAPTER 9 Examining Populations and Samples in Research

to as random sampling. For everyone in the accessible population to have an opportunity for

selection in the sample, each person in the population must be identified. To accomplish this,

the researcher must acquire a list of every member of the population, using the sampling criteria

to define eligibility. This list is referred to as the sampling frame. In some studies, the complete

sampling frame cannot be identified because it is not possible to list all members of the population.

The Health Insurance Portability and Accountability Act (HIPAA) has also increased the difficulty

in obtaining a complete sampling frame for many studies because of its requirements to protect

individuals’ health information (see Chapter 4 for more information on HIPAA). Once a sampling

frame is identified, researchers select subjects for their studies using a sampling plan or method.

Sampling Methods or Plans Sampling methods or plans outline strategies used to obtain samples for studies. Like a design, a

sampling plan is not specific to a study. The sampling plan may include probability (random) or

nonprobability (nonrandom) sampling methods. Probability sampling methods are designed to

? CRITICAL APPRAISAL GUIDELINES Adequacy of the Sampling Criteria, Acceptance or Refusal Rate, and Sample Attrition or Retention Rate

When critically appraising the samples of quantitative and outcomes studies, address the following questions:

1. Does the researcher define the target and accessible populations for the study?

2. Are the sampling inclusion criteria, sampling exclusion criteria, or both clearly identified and appropriate for

the study?

3. Is either the refusal or acceptance rate identified in the study? Are reasons provided for the potential subjects

who refused to participate?

4. Is the sample attrition or retention rate addressed in the study? Are reasons provided for those who withdrew

from the study?

RESEARCH EXAMPLE

Sampling Criteria, Acceptance or Refusal Rate, and Sample Attrition or Retention Rate

Research Excerpt Giakoumidakis and colleagues (2013) conducted a randomized controlled trial (RCT) to investigate the effects of

intensive blood glucose control (120 to 150 mg/dL) on cardiac surgery patient outcomes, such as mortality (in-

hospital and 30-day postdischarge), length of intensive care unit (ICU) stay, length of postoperative hospital stay,

duration of tracheal intubation, presence of severe hypoglycemic events, and incidence of postoperative infections.

The sampling criteria, acceptance rate, and sample retention rate from this study are presented here as an exam-

ple. Giakoumidakis and associates (2013) provided a description of their study sampling criteria and documented

the participants enrolled in their study using a flow diagram (see Figure 9-2 of this example). This flow diagram is

based on the CONsolidated Standards of Reporting Trials (CONSORT) Statement that is the international standard

for reporting the sampling process in RCTs (CONSORT Group, 2010; see Chapter 13 for more information on the

CONSORT statement).This study is critically appraised using the questions designated earlier in the Critical

Appraisal Guidelines box.

“The study was a randomized quasi-experimental trial. We treated blood glucose levels during the first

24 hours postoperatively [independent variable] in patients of the therapy group and compared them

with the control group. The inclusion criteria were: (1) open heart surgery, (2) surgery requiring CPB Continued

255CHAPTER 9 Examining Populations and Samples in Research

RESEARCH EXAMPLE—cont’d

[cardio-pulmonary bypass], (3) patient age�18 years old, and (4) the patient’s informed consent for partic- ipation in our study. The exclusion criteria included: (1) renal dysfunction or failure (preoperative

creatinine>1.5 mg/dL), (2) neurological or mental disorder, (3) chronic obstructive pulmonary disease, (4)

preoperative use of any type of antibiotics, (5) emergency and urgent surgeries, (6) history of previous cardiac

surgery, (7) ICU length of stay<24 hours, (8) mediastinal re-exploration for bleeding, (9) hemodynamic sup-

port with intra-aortic balloon pump (IABP) intraoperatively and/or during the first 24 hours postoperatively, and

(10) use of cardioversion for severe ventricular arrhythmias (ventricular tachycardia and/or fibrillation) within

the first 24 hours of ICU hospitalization. These criteria were established in an effort to ensure a more homog-

enous sample for our study.. . .

Over a period of 5 months (from September 2011 to January 2012), 298 patients were admitted to the 8-

bed cardiac surgery ICU. . . and were eligible for enrollment in the study. Two hundred and twelve out of 298

(71.1%) patients met the inclusion criteria and simultaneously did not meet the exclusion criteria and con-

sequently constituted our study sample (see Figure 9-2).

Assessed for eligibility (n=298) Enrollment

Randomized (n=212)

Allocation

Follow-Up

Analysis

Excluded (n=86) • Not meeting inclusion criteria (n=83) • Declined to participate (n=3) • Other reasons (n=0)

Allocated to intervention – Therapy group (n=105)

• Received allocated intervention (n=105) • Did not receive allocated intervention (n=0)

Allocated to usual care – Control group (n=107)

Lost to follow-up (n=0)

Discontinued usual care (n=0)

Analyzed (n=107)

• Received allocated usual care (n=107) • Did not receive allocated usual care (n=0)

• Excluded from analysis (n=0) • Excluded from analysis (n=0)

Analyzed (n=105)

Lost to follow-up (n=0)

Discontinued intervention (n=0)

FIG 9-2 CONSORT 2010 Flow Diagram. (Adapted from Giakoumidakis, K., Eltheni, R., Patelarou, E., Theologou, S., Patris, V., Michopanou, N., et al. [2013]. Effects of intensive glycemic control on outcomes of cardiac surgery. Heart & Lung, 42[2], p. 148.)

256 CHAPTER 9 Examining Populations and Samples in Research

increase representativeness and decrease systematic variation or bias in quantitative and outcomes

studies. When critically appraising a study, identify the study sampling plan as probability or non-

probability, and determine the specific method or methods used to select the sample. The different

types of probability and nonprobability sampling methods are introduced next.

PROBABILITY SAMPLING METHODS

In probability sampling, each person or element in a population has an opportunity to be selected

for a sample, which is achieved through random sampling. Probability or random sampling

methods increase the sample’s representativeness of the target population. All the subsets of the

One of the researchers, the same each time, randomly assigned patients, immediately postoperatively,

to the (odd numbers into the control group and the evens into the therapy group): (1) control group (n¼107) with a targeted blood glucose levels of 161-200 mg/dL, or (2) therapy group (n¼105) with blood glucose target of 120-160 mg/dL, or during the first 24 hours postoperatively. (see Figure 9-2).” (Giakoumidakis

et al., 2013, p. 147)

Critical Appraisal Giakoumidakis and co-workers (2013) identified specific inclusion and exclusion sampling criteria to designate the

subjects in the target population selectively. As the researchers indicated, the sampling criteria were narrowly defined

by the researchers to promote the selection of a homogeneous sample of cardiac surgery patients. These sampling

criteria were appropriate for this study to reduce the effects of possible extraneous variables on the implementation

of the treatment (blood glucose control) and the measurement of the dependent variables or outcomes (mortality,

length of ICU and hospital stays, duration of tracheal intubation, presence of severe hypoglycemic events, and inci-

dence of postoperative infection). The increased controls imposed by the sampling criteria strengthened the like-

lihood that the study outcomes were caused by the treatment and not by extraneous variables.

These researchers assessed 298 patients for eligibility in the study, but 83 of them did not meet the sampling cri-

teria. Thus 215 patients met the sampling criteria. However, three of these patients declined or refused to participate

in the study, resulting in a 1.4% (3 � 215�100%¼0.014�100%¼1.4%) refusal rate. Figure 9-2 indicates that the sample of 212 patients was equally randomized into the control group (n¼107) and therapy group (n¼105). There was no attrition of subjects from this study, as indicated in Figure 9-2, in which the starting group sizes were the

same at the end and all subjects (N¼212) were included in the data analyses. This study had very rigorous sampling criteria, low refusal rate of 1.4% (acceptance rate of 98.6%), and 0% attrition rate, which increased the represen-

tativeness of the sample of the accessible and target populations. The study would have been strengthened by the

researchers including not only the numbers but also the sample refusal rate and the reasons for the three patients

refusing to participate in the study.

Implications for Practice Giakoumidakis and colleagues (2013) found that only the in-hospital mortality rate was significantly affected by the

intensive blood glucose control. The postoperative glycemic control did not affect the other patient outcomes that

were studied. However, the researchers recognized that the sample size was small for a RCT, which limited the num-

bers of patients in the control and therapy groups. In addition, the study was conducted using only the patients from

one hospital. Therefore the researchers recommended that future studies include larger samples obtained from a

variety of hospitals. This initial research indicates that intensive blood glucose control is important to cardiac

patients’ mortality and might have other beneficial effects on patient outcomes in future research. The Quality

and Safety Education for Nurses (QSEN) importance is that these research findings provide knowledge to address

patient-centered care and safety competencies to promote quality care to patients and families (QSEN, 2013;

Sherwood & Barnsteiner, 2012).

257CHAPTER 9 Examining Populations and Samples in Research

population, which may differ from each other but contribute to the parameters (e.g., the means

and standard deviations) of the population, have a chance to be represented in the sample. The

opportunity for systematic bias is less when subjects are selected randomly, although it is possible

for a systematic bias to occur by chance.

Without random sampling strategies, researchers, who have a vested interest in the study, might

tend (consciously or unconsciously) to select subjects whose conditions or behaviors are consistent

with the study hypotheses. For example, researchers may exclude potential subjects because they

are too sick, not sick enough, coping too well, not coping adequately, uncooperative, or noncom-

pliant. By using random sampling, however, researchers leave the selection to chance, thereby

increasing the validity of their study findings.

There are four sampling designs that achieve probability sampling included in this text—simple

randomsampling,stratifiedrandomsampling,clustersampling,andsystematicsampling.Table9-1

identifies the common probability and nonprobability sampling methods used in nursing studies,

TABLE 9-1 PROBABILITY AND NONPROBABILITY SAMPLING METHODS

SAMPLING METHOD COMMON APPLICATION(S) REPRESENTATIVENESS

Probability

Simple random

sampling

Quantitative and outcomes

research

Strong representativeness of the target

population that increases with sample size

Stratified random

sampling

Quantitative and outcomes

research

Strong representativeness of the target

population that increases with control of

stratified variable(s)

Cluster sampling Quantitative and outcomes

research

Less representative of the target population than

simple random sampling and stratified random

sampling

Systematic sampling Quantitative and outcomes

research

Less representative of the target population than

simple random sampling and stratified random

sampling methods

Nonprobability

Convenience sampling Quantitative, qualitative, and

outcomes research

Questionable representativeness of the target

population that improves with increasing sample

size; may be representative of the phenomenon,

process, or cultural elements in qualitative

research

Quota sampling Quantitative and outcomes

research and, rarely,

qualitative research

Use of stratification for selected variables in

quantitative research makes the sample more

representative than convenience sampling.

In qualitative research, stratification might be used

to provide greater understanding and increase

the representativeness of the phenomenon,

processes, or cultural elements.

Purposeful or

purposive sampling

Qualitative and sometimes

quantitative research

Focus is on insight, description, and

understanding of a phenomenon or process with

specially selected study participants.

Network or snowball

sampling

Qualitative and sometimes

quantitative research

Focus is on insight, description, and

understanding of a phenomenon or process in a

difficult to access population.

Theoretical sampling Qualitative research Focus is on developing a theory in a selected area.

258 CHAPTER 9 Examining Populations and Samples in Research

their applications, and their representativeness for the study. Probability and nonprobability sam-

plingmethodsareusedinquantitativeandoutcomesstudies,andnonprobabilitysamplingmethods

are used in qualitative studies (Fawcett & Garity, 2009; Munhall, 2012).

Simple Random Sampling Simple random sampling is the most basic of the probability sampling plans. It is achieved by

randomly selecting elements from the sampling frame. Researchers can accomplish random selec-

tion in a variety of ways; it is limited only by the imagination of the researcher. If the sampling

frame is small, researchers can write names on slips of paper, place them into a container, mix them

well, and then draw them out one at a time until they have reached the desired sample size. The

most common method for randomly selecting subjects for a study is use of a computer program.

The researcher can enter the sampling frame (list of potential subjects) into a computer, which will

then randomly select subjects until the desired sample size is achieved.

Another method for randomly selecting a study sample is use of a table of random numbers.

Table 9-2 displays a section from a random numbers table. To use a table of random numbers, the

researcher places a pencil or finger on the table with eyes closed. That number is the starting place.

Then, by moving the pencil or finger up, down, right, or left, numbers are identified in order until

the desired sample size is obtained. For example, you want to select five subjects from a population

of 100, and the number 58 is initially selected as a starting point (fourth column from the left,

fourth row down), your subject numbers would be 58, 25, 15, 55, and 38. Table 9-2 is useful only

when the population number is less than 100. Full tables of random numbers are available from

other sources (Grove et al., 2013).

TABLE 9-2 SECTION FROM A RANDOM NUMBERS TABLE

06 84 10 22 56 72 25 70 69 43

07 63 10 34 66 39 54 02 33 85

03 19 63 93 72 52 13 30 44 40

77 32 69 58 25 15 55 38 19 62

20 01 94 54 66 88 43 91 34 28

RESEARCH EXAMPLE

Simple Random Sampling

Research Excerpt Lee, Faucett, Gillen, Krause, and Landry (2013) conducted a predictive correlational study to determine critical care

nurses’ perception of the risk of musculoskeletal (MSK) injury. The researchers randomly selected (sampling

method) 1000 critical care nurses from the 2005 American Association of Critical Care (AACN) membership list

(sampling frame). “A total of 412 nurses returned completed questionnaires (response rate¼41.5%, excluding eight for whom mailing addresses were incorrect). Of these, 47 nurses who did not meet the inclusion criteria were

excluded: not currently employed (n¼5); not employed in a hospital (n¼1); not employed in critical care (n¼8); not a staff or charge nurse (n¼28); or not performing patient-handling tasks (n¼5). In addition, four nurses employed in a neonatal ICU were excluded because of the different nature of their physical workload.

The final sample for data analysis comprised 361 [sample size] critical care nurses.” (Lee et al., 2013, p. 38)

Critical Appraisal Lee and associates (2013) clearly identified that a random sampling method was used to select study participants

from a population of critical care nurses. The 41.5% response rate for mailed questionnaires is considered adequate, Continued

259CHAPTER 9 Examining Populations and Samples in Research

Stratified Random Sampling Stratified random sampling is used in situations in which the researcher knows some of the vari-

ables in the population that are critical for achieving representativeness. Variables commonly used

for stratification include age, gender, race and ethnicity, socioeconomic status, diagnosis, geo-

graphic region, type of institution, type of care, type of registered nurse, nursing area of special-

ization, and site of care. Stratification ensures that all levels of the identified variables are

adequately represented in the sample. With stratification, researchers can use a smaller sample size

to achieve the same degree of representativeness relative to the stratified variable than can be

derived from using a larger sample acquired through simple random sampling. One disadvantage

is that a large population must be available from which to select subjects.

If researchers have used stratification, they must define categories (strata) of the variables

selected for stratification in the published report. For example, using race and ethnicity for strat-

ification, the researcher may define four strata—white, non-Hispanic; black; Hispanic; and other.

The population may be 60% white, non-Hispanic; 20% black; 15% Hispanic; and 5% other.

Researchers may select a random sample for each stratum equivalent to the target population pro-

portions of that stratum. Thus a sample of 100 subjects would need to include approximately 60

white, non-Hispanic; 20 black; 15 Hispanic; and 5 other. Alternatively, equal numbers of subjects

may be randomly selected for each stratum. For example, if age is used to stratify a sample of 100

adult subjects, the researcher may obtain 25 subjects 18 to 34 years of age, 25 subjects 35 to 50 years

of age, 25 subjects 51 to 66 years of age, and 25 subjects older than 66 years of age.

RESEARCH EXAMPLE—cont’d

because the response rate to questionnaires averages 25% to 50% (Grove et al., 2013). The 47 nurses who did not

meet sample criteria and the four nurses working in a neonatal ICU were excluded, ensuring a more homogeneous

sample and decreasing the potential effect of extraneous variables. These sampling activities limit the potential for

systematic variation or bias and increase the likelihood that the study sample is representative of the accessible and

target populations. The study would have been strengthened if the researchers had indicated how the nurses were

randomly selected from the AACN membership list, but this was probably a random selection by a computer.

Implications for Practice Lee and co-workers (2013, p. 43) identified the following findings from their study: “Improving the physical and

psychosocial work environment may make nursing jobs safer, reduce the risk of MSK injury, and improve nurses’

perceptions of job safety. Ultimately, these efforts would contribute to enhancing safety in nursing settings and to

maintaining a healthy nursing workforce. Future research is needed to determine the role of risk perception in pre-

venting MSK injury.” The QSEN importance is that the findings from this study contribute to the safety compe-

tencies in which strategies are used to reduce the risk of harm to nurses and others (QSEN, 2013).

RESEARCH EXAMPLE

Stratified Random Sampling

Research Excerpt Toma, Houck, Wagnild, Messecar, and Jones (2013, p. 16) conducted a predictive correlational study “to identify

predictors of physical function in older adults living with fibromyalgia (FM) and to examine the influence of resil-

ience on the relationship between fibromyalgia pain and physical function.” This study included a stratified random

sample that is described in the following study excerpt:

“An age-stratified random sample [sampling method] of 400 community-dwelling older adults was created

from a database of FM patients [population] at a large academic medical center in the Pacific Northwest.

260 CHAPTER 9 Examining Populations and Samples in Research

Cluster Sampling In cluster sampling, a researcher develops a sampling frame that includes a list of all the states,

cities, institutions, or organizations with which elements of the identified population can be

linked. A randomized sample of these states, cities, institutions, or organizations can then be used

in the study. In some cases this randomized selection continues through several stages and is then

referred to as multistage sampling. For example, the researcher may first randomly select states and

then randomly select cities within the sampled states. Next, the researcher may randomly select

hospitals within the randomly selected cities. Within the hospitals, nursing units may be randomly

selected. At this level, all the patients on the nursing unit who fit the criteria for the study may be

included, or patients can be randomly selected.

Cluster sampling is commonly used in two types of research situations. In the first situation, the

researcher considers it necessary to obtain a geographically dispersed sample but recognizes that

obtaining a simple random sample will require too much travel time and expense. In the second,

the researcher cannot identify the individual elements making up the population and therefore

cannot develop a sampling frame. For example, a complete list of all people in the United States

who have had open heart surgery does not exist. Nevertheless, it is often possible to obtain lists of

institutions or organizations with which the elements of interest are associated—in this example,

perhaps large medical centers, university hospitals with cardiac surgery departments, and large

cardiac surgery practices—and then randomly select institutions from which the researcher can

acquire subjects.

The database included over 5,000 community-dwelling FM patients who had been diagnosed with FM (ICD-9

729.1) in clinical practice or as a participant in FM clinical trials [sampling frame]. Limits were set on the data-

base to extract only those persons 50 years of age and older who had participated in FM studies in the last

2 years [sampling criteria and target population]. An age of 50 years was selected as the lower limit because

FM often begins in the third and fourth decade of life and can impact PF [physical function].. . . Those persons

extracted were then placed into an Excel spreadsheet and stratified into five age groups (50-54, 55-59, 60-64,

65-69, 70+ years). Eighty persons were selected randomly from each group and invited to participate in the

study.” (Toma et al., 2013, p. 17). Of the 400 invited to participate in the study, 224 returned the completed

questionnaires, for a response rate of 56%.

Critical Appraisal Toma and colleagues (2013) clearly identified their population as community-dwelling FM patients and the sam-

pling frame was large, including 5000 FM patients in a national database. The researchers provided a sound rationale

for limiting the sample to FM patients 50 years of age and older. Stratification by age groups seemed important in

this study to control extraneous variables that could affect physical function. Most of the categories for stratification

were equal, with each age group including 5 years, except for the last category. The random selection of 80 FM

patients for each of the age groups increased the representativeness of the strata in the sample. In summary, this

study included a rigorous stratified random sampling method that resulted in a large sample (n¼224) of FM patients who were fairly equally distributed among the five age groups. This sampling process increased the repre-

sentativeness of the sample and decreased the potential for systematic error or bias.

Implications for Practice Toma and associates (2013) found that resilience was a predictor of physical function in this sample of community-

dwelling FM patients. However, they recommended further research to promote understanding of the relationships

among resilience, FM impact, and the aging process.

261CHAPTER 9 Examining Populations and Samples in Research

Systematic Sampling Systematic sampling is used when an ordered list of all members of the population is available.

The process involves selecting every kth individual on the list, using a starting point selected ran-

domly. If the initial starting point is not random, the sample is a nonprobability or nonrandom

sample. To use this design, the researcher must know the number of elements in the population

and the size of the sample desired. The population size is divided by the desired sample size, giving

k, the size of the gap between elements selected from the list. For example, if the population size is

N¼1200 and the desired sample size is n¼100, then k¼12. Thus the researcher would include every 12th person on the list in the sample. You obtain this value by using the following formula:

RESEARCH EXAMPLE

Cluster Sampling

Research Excerpt Fouladbakhsh and Stommel (2010, p. E8) used multistage cluster sampling in their study of the “complex relation-

ships among gender, physical and psychological symptoms, and use of specific CAM [complementary and alterna-

tive medicine] health practices among individuals living in the United States who have been diagnosed with cancer.”

These researchers described their sampling method in the following excerpt and the particular aspects of the sample

have been identified in [brackets].

“The NHIS [National Health Interview Survey] methodology employs a multistage probability cluster sam-

pling design [sampling method] that is representative of the NHIS target universe, defined as ‘the civilian

noninstitutionalized population’ [sampling frame] (Botman, Moore, Moriarty, & Parsons, 2000, p. 14; National

Center for Health Statistics). In the first stage, 339 primary sampling units were selected from about 1,900

area sampling units representing counties, groups of adjacent counties, or metropolitan areas covering the 50

states and the District of Columbia [1st stage cluster sampling]. The selection includes all of the most pop-

ulous primary sampling units in the United States and stratified probability samples (by state, area poverty

level, and population size) of the less populous ones. In a second step, primary sampling units were parti-

tioned into substrata (up to 21) based on concentrations of African American and Hispanic populations

[2nd stage cluster sampling]. In a third step, clusters of dwelling units form the secondary sampling units

selected from each substratum [3rd stage cluster sampling]. Finally, within each secondary sampling unit,

all African American and Hispanic households were selected for interviews, whereas other households were

sampled at differing rates within the substrata. Therefore, the sampling design of the NHIS includes over-

sampling of minorities.” (Fouladbakhsh & Stommel, 2010, pp. E8-E9)

Critical Appraisal These researchers detailed their use of multistage cluster sampling and clearly identified the three stages of cluster

sampling implemented and the rationale for each stage. The study had a large national sample that seemed repre-

sentative of all 50 states and the District of Columbia, with an oversampling of minorities to accomplish the purpose

of the study. The complex cluster sampling method used in this study provided a representative sample, which

decreases the likelihood of sampling error and increases the validity of the study findings.

Implications for Practice Their findings (Fouladbakhsh and Stommel, 2010, p. E7) indicated that “CAM practice use was more prevalent

among female, middle-aged, Caucasian, and well-educated subjects. Pain, depression, and insomnia were strong

predictors of practice use, with differences noted by gender and practice type.” Nurses need to be aware of the

CAM practices of their cancer patients and incorporate this information when managing their care. The QSEN

importance is that this research-based knowledge encourages nurses to deliver patient-centered care to patients

and families (QSEN, 2013).

262 CHAPTER 9 Examining Populations and Samples in Research

k ¼ Population size � by the desired sample size Example:

k ¼ 1200 subjects in the population � 100 desired sample size ¼ 12 Some argue that this procedure does not actually give each element of a population an oppor-

tunity to be included in the sample and does not provide as representative a sample as simple ran-

dom sampling and stratified random sampling. Systematic sampling provides a random but not

equal chance for inclusion of participants in a study (Kerlinger & Lee, 2000).

NONPROBABILITY SAMPLING METHODS COMMONLY USED IN QUANTITATIVE RESEARCH

In nonprobability sampling, not every element of a population has an opportunity to be selected

for a study sample. Although this approach decreases a sample’s representativeness of a target pop-

ulation, it commonly is used in nursing studies because of the limited number of patients available

for research. Thus it is important to be able to discriminate among the various nonprobability

sampling plans used in nursing research. The five nonprobability sampling plans used most fre-

quently in nursing research are convenience sampling, quota sampling, purposive or purposeful

sampling, network sampling, and theoretical sampling. Convenience sampling is frequently used

in quantitative, qualitative, and outcomes nursing studies. Quota sampling is occasionally used

in quantitative and outcomes studies. Purposive, network, and theoretical sampling are used more

frequently in qualitative research and are discussed later in this chapter. Table 9-1 provides a list of

the common applications of these sampling methods and the representativeness achieved by them.

RESEARCH EXAMPLE

Systematic Sampling

Research Excerpt De Silva, Hanwella, and de Silva (2012) used systematic sampling in their outcomes study of the direct and indirect

costs of care incurred by patients with schizophrenia (population) in a tertiary care psychiatric unit.

“Systematic sampling [sampling method] selected every second patient with an ICD-10 clinical diagnosis of

schizophrenia [target population] presenting to the clinic during a two-month period [sampling frame]. . . .

Sample consisted of 91 patients [sample size]. Direct cost was defined as cost incurred by the patient

(out-of-pocket expenditure) for outpatient care.” (De Silva, et al., 2012, p. 14)

Critical Appraisal De Silva and co-workers (2012) clearly identified that systematic sampling was used in their study. The population

and target population were appropriate for this study. Using systematic sampling increased the representativeness of

the sample, and the sample size of 91 schizophrenic patients seems adequate for the focus of this study. However, the

sampling frame was identified as only the patients presenting over 2 months, and k was small (every second patient)

in this study. The researchers might have provided more details on how they implemented the systematic sampling

method to ensure that the start of the sampling process was random (Grove et al., 2013).

IMPLICATIONS FOR PRACTICE De Silva and colleagues (2012, p. 14) concluded that “despite low direct cost of care, indirect cost and cost of infor-

mal treatment results in substantial economic impact on patients and their families. It is recommended that eco-

nomic support should be provided for patients with disabling illnesses such as schizophrenia, especially when

patients are unable to engage in full-time employment.”

263CHAPTER 9 Examining Populations and Samples in Research

Convenience Sampling Convenience sampling, also called accidental sampling, is a weak approach because it provides

little opportunity to control for biases; subjects are included in the study merely because they hap-

pen to be in the right place at the right time (Grove et al., 2013; Kerlinger & Lee, 2000). A classroom

of students, patients who attend a clinic on a specific day, subjects who attend a support group, and

patients hospitalized with specific medical diagnoses or nursing problems are examples of conve-

nience samples. The researcher simply enters available subjects into the study until the desired

sample size is reached. Multiple biases may exist in the sample, some of which may be subtle

and unrecognized. However, serious biases are not always present in convenience samples. Accord-

ing to Kerlinger and Lee (2000), a convenience sample is acceptable when it is used with reasonable

knowledge and care in implementing a study.

Convenience samples are inexpensive, accessible, and usually less time-consuming to obtain

than other types of samples. This type of sampling provides a means to conduct studies on nursing

interventions when researchers cannot use probability sampling methods. Convenience sampling

method is commonly used in healthcare studies because most researchers have limited access to

patients who meet study sample criteria. Probability or random sampling is not possible when the

pool of potential patients is limited. Researchers often think it best to include all patients who meet

sample criteria (sample of convenience) to increase the sample size.

For some healthcare studies, the sampling frames for some populations are not available, so

researchers often use a sample of convenience. Many researchers are now conducting quasi-

experimental studies and clinical trials in medicine and nursing, and these types of studies fre-

quently require the use of the convenience sampling method. As a component of these study

designs, subjects usually are randomly assigned to groups. This random assignment to groups,

which is not a sampling method but a design strategy, does not alter the risk of biases resulting

from convenience sampling but does strengthen the equivalence of the study groups. With these

potential biases and the narrowly defined sampling criteria used to select subjects in most clinical

trials, representativeness of the sample is a concern. To strengthen the representativeness of a sam-

ple, researchers often increase the sample size for clinical trials (Parent & Hanley, 2009). Sample

size is discussed later in this chapter.

RESEARCH EXAMPLE

Convenience Sampling

Research Excerpt Long and associates (2013, p. 17) conducted a quasi-experimental study to test “the effectiveness of using cell phones

with digital pictures to prompt memory and use of mypyramidtracker.gov to estimate self-reported fruit and veg-

etable intake in 69 college students.” The intervention involved study participants taking pictures of what they had

eaten to review later when reporting dietary intake on a government website that calculated the nutritional value of

the intake. The website during the study was mypyramidtracker.gov and is now https://www.supertracker.usda.gov/

default.aspx. The following excerpt describes their sampling process.

“After obtaining approval from the institutional review board, a convenience sample of college-age students

[population] was recruited from a local university through campus and class announcements.. . . A sample of

146 college-age students [sample size] from various majors who were enrolled in coursework in the Depart-

ment of Exercise and Sports Sciences was obtained [target population]. After study attrition, 69 subjects

remained in the study.” (Long et al., 2013, p. 20)

264 CHAPTER 9 Examining Populations and Samples in Research

Quota Sampling Quota sampling uses a convenience sampling technique with an added feature—a strategy to

ensure the inclusion of subject types likely to be underrepresented in the convenience sample, such

as females, minority groups, older adults, and the poor, rich, and undereducated. The goal of quota

sampling is to replicate the proportions of subgroups present in the target population. This tech-

nique is similar to that used in stratified random sampling. Quota sampling requires that the

researcher be able to identify subgroups and their proportions in the target population in order

to achieve representativeness for the problem being studied. Quota sampling offers an improve-

ment over convenience sampling and tends to decrease potential biases.

Critical Appraisal Long and co-workers (2013) clearly identified their sampling method and indicated that college students from var-

ious majors were included in the sample, which increases the representativeness of the sample of university students.

The original sample was strong, with 146 students included in the study, but the attrition was high, with 77 students

withdrawing from the study, leaving a sample of 69 (146�69¼77). The researchers needed to provide more details about the students withdrawing from this study. Because this study used a nonprobability sampling method and had

a high attrition rate (53%), the sample had decreased representativeness of the target population, which increased

the potential for error and decreased the ability to generalize the findings.

Implications for Practice Long and colleagues (2013, p. 17) found a significant difference between the use of cell phone versus short-term

memory in recording diet information. “Cell phone pictures improved memory and accuracy of recall when using

an online self-reported interactive diet record and was considered an easy, relevant, and accessible way to record

diet.” The researchers encouraged nurses to provide nutrition counseling that included technology, such as the

use of cell phone to help improve diet management.

RESEARCH EXAMPLE

Quota Sampling

Research Excerpt Pieper, Templin, Kirsner, and Birk (2010) used quota sampling to examine the impact of vascular leg disorders, such

as chronic venous disorders (CVDs) and peripheral arterial disease (PAD), on the physical activity levels of opioid-

addicted adults in a methadone maintenance program. The following excerpt describes their sampling process:

“The sample (n¼713) was obtained from September 2005 to December 2007 from 12 methadone treatment clinics [settings] located in a large urban area [convenience sampling]. The sample was stratified on four vari-

ables: age (25-39 years, 40-49 years, 50-65 years); gender (male, female); ethnicity (African American, white);

and drug use (non-IDU [injection drug use], arm/upper body injection only, or legs�upper body injection [quota sampling].. . . The purpose of the stratification was to allow comparisons of type of drug use with min-

imal confounding by age, gender, or ethnicity. Additional inclusion criteria included presence of both legs, able

to walk, and able to speak and understand English. The analyses reported here are on the 569 participants

who completed the revised LDUQ [Legs in Daily Use Questionnaire], which were edited after examining the

test-retest data from 104 participants, not included in the 569, who were tested first.” (Pieper et al., 2010,

p. 429)

Critical Appraisal Pieper and associates (2010) clearly identified that the original sample was one of convenience because it was people

attending 12 methadone treatment clinics who were willing to participate in the study. The quota sampling involved Continued

265CHAPTER 9 Examining Populations and Samples in Research

SAMPLE SIZE IN QUANTITATIVE STUDIES

One of the most troublesome questions that arises during the critical appraisal of a study is

whether the sample size was adequate. If the study was designed to make comparisons and signif-

icant differences were found, the sample size, or number of subjects participating in the study, was

adequate. Questions about the adequacy of the sample size occur only when no significance is

found. When critically appraising a quantitative study in which no significance was found for

at least one of the hypotheses or research questions, be sure to evaluate the adequacy of the sample

size. Is there really no difference? Or was an actual difference not found because of inadequacies in

the research methods, such as a small sample size?

Currently the adequacy of the sample size in quantitative studies is evaluated using a power

analysis. Power is the ability of the study to detect differences or relationships that actually exist

in the population. Expressed another way, it is the ability to reject a null hypothesis correctly. The

minimum acceptable level of power for a study is 0.8, or 80% (Aberson, 2010; Cohen, 1988). This

power level results in a 20% chance of a type II error, in which the study fails to detect existing

effects (differences or relationships). An increasing number of researchers are performing a power

analysis before conducting their study to determine an adequate sample size. The results of this

analysis are usually included in the sample section of the published study. Researchers also need

to perform a power analysis to evaluate the adequacy of their sample size for all nonsignificant

findings and include this in the discussion section of their published study.

Parent and Hanley (2009) reviewed the reports of 54 RCTs published in Applied Nursing

Research, Heart & Lung, and Nursing Research and found that sample sizes were estimated in

advance in only 22% of the studies. This is of particular concern in RCTs, because these studies

are designed to test the effects of interventions. Samples that are too small can result in studies

that lack power to identify significant relationships among variables or differences among groups.

Low-powered studies increase the risk of a type II error—saying something is not significant when

it is actually significant.

RESEARCH EXAMPLE—cont’d

stratification of the sample on four variables, with a clear rationale for the variables selected for stratification. A total

of 569 participants completed the study, but an additional 104 participants were used for examining the test-retest

reliability of the LDUQ and were not included in the final sample. The study had a small attrition of 40 participants

(attrition rate¼(40 � 569)�100%¼0.07�100%¼7%). The use of quota sampling controlled selected variables to ensure that the study sample was more representative of the target population than using convenience sampling

alone. In addition, the participants were obtained from 12 different clinics, and the sample size was large

(n¼713�104 [used only for instrument reliability testing]¼569). Pieper and co-workers’ (2010) sample appeared to be representative of the target population, with limited potential for sampling error.

Implications for Practice Pieper and colleagues (2010) provided the following implications for practice and recommendations for further

research:

“Mobility is an important consideration for persons in drug therapy. Because physical activity levels were low

and motivation was the strongest predictor of physical activity, reasons for low activity need continued explo-

ration. Individualized motivational exercise prescriptions need to be developed and tested for those in drug

treatment. Methods to encourage physical activity and increase its everyday use may positively influence the

general health status of those in drug treatment.” (Pieper et al., 2010, p. 438)

The QSEN (2013) importance is the use of evidence-based knowledge to provide patient-centered care to a pop-

ulation that is often underserved in the healthcare system.

266 CHAPTER 9 Examining Populations and Samples in Research

Other factors that influence the adequacy of sample size (because they affect power) include

effect size, type of quantitative study, number of variables, sensitivity of the measurement methods,

and data analysis techniques. When critically appraising the adequacy of the sample size, consider

the influence of all these factors, which are discussed in the next sections.

Effect Size The effect is the presence of the phenomenon examined in a study. The effect size is the extent to

which the null or statistical hypothesis is false. In a study in which the researchers are comparing

two populations, the null hypothesis states that the difference between the two populations is zero.

However, if the null hypothesis is false, an identifiable effect is present—a difference between the

two groups does exist. If the null hypothesis is false, it is false to some degree; this is the effect size

(Cohen, 1988). The statistical test tells you whether there is a difference between groups, or

whether variables are significantly related. The effect size tells you the size of the difference between

the groups or the strength of the relationship between two variables.

When the effect size is large (e.g., considerable difference between groups or very strong rela-

tionship between two variables), detecting it is easy and requires only a small sample. When the

effect size is small (e.g., only a small difference between groups or a weak relationship between two

variables), detecting it is more difficult and requires larger samples. The following are guidelines

for categorizing the quality of the effect size (Aberson, 2010; Grove et al., 2013):

Small effect size < 0:30 or < �0:30 Medium effect size ¼ 0:30 to 0:50 or � 0:30 to � 0:50

Large effect size > 0:50 or > 0:50� Effectsizeissmallerwithasmallsample,soeffectsaremoredifficulttodetect.Increasingthesample

size also increases the effect size, making it more likely that the effect will be detected and the study

findings will be significant. When critically appraising a study, determine whether the study sample

size was adequate by noting whether a power analysis was conducted and what power was achieved.

Examine the attrition rate for the study todetermine the final sample sizefordataanalysis. Also, check

to see if the researchers examined the power level when findings were not significant.

Types of Quantitative Studies Descriptive studies (particularly those using survey questionnaires) and correlational studies often

requireverylargesamples.Inthesestudies,researchersmayexaminemultiplevariables,andextraneous

variables are likely to affect subject response(s) to the variables under study. Researchers often make

statistical comparisons on multiple subgroups in a sample, such as groups formed by gender, age, or

ethnicity, requiring that an adequate sample be available for each subgroup being analyzed. Quasi-

experimental and experimental studies use smaller samples more often than descriptive and correla-

tional studies. As control in the study increases, the sample size can be decreased and still approximate

thetargetpopulation.Instrumentsinthesestudiestendtobemorerefined,withstrongerreliabilityand

validity.Thetypeofstudydesigncaninfluencesamplesize,suchasusingmatchedpairsofsubjects,which

increases the power to identify group difference and decreases the sample size needed (see Chapter 8).

Number of Variables As the number of variables under study increases, the sample size needed may increase. For exam-

ple, the inclusion of multiple dependent variables in a study increases the sample size needed.

Including variables such as age, gender, ethnicity, and education in the data analyses can increase

the sample size needed to detect differences between groups. Using them only to describe the sam-

ple does not cause a problem in terms of power.

267CHAPTER 9 Examining Populations and Samples in Research

Measurement Sensitivity Well-developed physiological instruments measure phenomena with accuracy and precision. A

thermometer, for example, measures body temperature accurately and precisely. Tools measuring

psychosocial variables tend to be less precise. However, a tool that is reliable and valid measures

more precisely than a tool that is less well developed. Variance tends to be higher with a less well-

developed tool than with one that is well developed. For example, if you are measuring anxiety, and

the actual anxiety score of several subjects is 80, you may obtain measures ranging from 70 to 90

with a less well-developed tool. Much more variation from the true score occurs with new or less

developed scales than when a well-developed scale is used, which will tend to show a score closer to

the actual score of 80 for each subject. As variance in instrument scores increases, the sample size

needed to obtain significance increases (see Chapter 10).

Data Analysis Techniques Data analysis techniques vary in their capability to detect differences in the data. Statisticians refer

to this as the “power of the statistical analysis.” An interaction also occurs between the measure-

ment sensitivity and power of the data analysis technique. The power of the analysis technique

increases as precision in measurement increases. Thus techniques for analyzing variables measured

at interval and ratio levels are more powerful in detecting relationships and differences than those

used to analyze variables measured at nominal and ordinal levels (see Chapter 10 for more details

on levels of measurement). Larger samples are needed when the power of the planned statistical

analysis is weak.

For some statistical procedures, such as the t-test and analysis of variance (ANOVA), equal

group sizes will increase power because the effect size is maximized. The more unbalanced are

the group sizes, the smaller is the effect size. Therefore, in unbalanced groups, the total sample

size must be larger (Kraemer & Theimann, 1987). The chi-square test is the weakest of the statis-

tical tests and requires very large sample sizes to achieve acceptable levels of power. As the number

of categories increases, the sample size needed increases. Also, if some of the categories contain

small numbers of subjects, the total sample size must be increased. Chapter 11 describes the t-test,

ANOVA, and chi-square statistical analysis techniques in more detail.

? CRITICAL APPRAISAL GUIDELINES Adequacy of the Sampling Processes in Quantitative Studies

When critically appraising the sampling processes of quantitative studies, address the following questions:

1. Does the researcher define the target and accessible populations for the study?

2. Are the sampling inclusion criteria, sampling exclusion criteria, or both clearly identified and appropriate for

the study?

3. Is the sample size identified? Is a power analysis reported? Was the sample size appropriate, as indicated by

the power analysis? If groups were included in the study, is the sample size for each group equal and

appropriate?

4. Is the refusal or acceptance rate identified? Is the sample attrition or retention rate addressed? Are reasons

provided for the refusal and attrition rates?

5. Is the sampling method probability or nonprobability? Identify the specific sampling method used in the study

to obtain the sample.

6. Is the sampling method adequate to achieve a representative sample? Is the sample representative of the

accessible and target populations?

268 CHAPTER 9 Examining Populations and Samples in Research

RESEARCH EXAMPLE

Quantitative Study Sample

Research Excerpt Hodgins, Ouellet, Pond, Knorr, and Geldart (2008) conducted a quasi-experimental study to examine the effect of a

telephone follow-up on surgical orthopedic patients’ postdischarge recovery. “The sample consisted of 438 patients

randomly assigned to receive routine care with or without telephone follow-up 24 to 72 hours after discharge (inter-

vention)” (Hodgins et al., 2008, p. 218). The sample and setting are described in the following excerpt, and the

particular aspects of the sample have been identified [in brackets]. The sample is critically appraised using the

questions in the Critical Appraisal Guidelines box.

“The study population consisted of adult patients admitted for either elective or emergent orthopedic surgery

in a regional referral hospital in Eastern Canada [setting] between January and December 2002. The selection

and inclusion criteria required that the patients be (a) English-speaking, (b) able to communicate by telephone,

(c) free of mental confusion, and (d) discharged to a private residence [sampling criteria]. The required sample

size was estimated based on a desired power of 0.80, a present alpha¼0.05, 11 predictor variables, and an anticipated weak intervention effect.. . . Using these criteria, we estimated that a minimum of 390 partic-

ipants would be required to detect a difference in the number of postdischarge problems experienced by the

intervention and control groups [power analysis].” (Hodgins et al., 2008, p. 220)

“The final sample consisted of 438 participants [sample size with 216 in the intervention group and 222

in the control group]. Of the 511 patients enrolled, 73 were lost to follow-up, resulting in an overall retention

rate of 85.5%. Reasons for loss to follow-up included the following: unable to be contacted for the outcome

interview, n¼38; transferred to another unit, n¼20; declined to participate at the time of the outcome inter- view, n¼8; death, n¼2; problem with data entry, n¼1; and unspecified, n¼4. A number of the recruited cases (n¼22) were lost before their random group assignment, which was done immediately before the telephone follow-up.” (Hodgins et al., 2008, pp. 221-222)

Critical Appraisal Hodgins and associates (2008) clearly described their study population, setting, sampling criteria, and sample size,

which was determined with power analysis. The final sample size of 438 was strong and included 48 more subjects

than the 390 subjects required by the power analysis. The retention rate of 85.5% was strong, and the reasons for the

attrition seemed common and were not a bias for the sample, based on the size of the original sample and length of

the study. The attrition of subjects was fairly comparable for the intervention group (n¼216) and control group (n¼222). The researchers did not identify the acceptance or refusal rate that might have been a source of bias for the study.

The study would have been strengthened by the researchers clearly identifying the sampling method, which

appeared to be a sample of convenience. The sample of convenience has a potential to bias the study results but

adequate sample size, limited attrition, and comparably sized intervention and control groups increased the

sample’s representativeness of the target population (Grove et al. 2013; Kerlinger & Lee, 2000).

Implications for Practice Hodgins and co-workers (2008) found that the telephone follow-up intervention did not have a significant effect

on the surgical orthopedic patients’ postdischarge recovery. The limitations of the intervention included making

the phone calls too early after discharge, short duration of the calls, and limited qualifications of the nurses mak-

ing the calls. In future studies, the researchers recommended that the requirements of the telephone follow-up

programs and outcome measures be explicitly developed. However, the study clearly described the postdischarge

experiences of surgical orthopedic patients and what nurses can do to promote their recovery. The main patient

symptoms that required management in the home were pain, constipation, and swelling. Patients need to under-

stand these symptoms and how they could manage them at home to promote their recovery. The QSEN (2013)

importance is the identified patient symptoms that nurses need to manage for postsurgical patients to ensure

quality and safe care.

269CHAPTER 9 Examining Populations and Samples in Research

SAMPLING IN QUALITATIVE RESEARCH

Qualitative research is conducted to gain insights and discover meaning about a particular phe-

nomenon, situation, cultural element, or historical event (Fawcett & Garity, 2009; Munhall,

2012). The intent of qualitative research is an in-depth understanding of a phenomenon or topic

in a specially selected sample, not on the generalization of findings from a randomly selected

sample to a target population, as in quantitative research. The sampling in qualitative research

focuses more on experiences, events, incidents, and settings than on people (Sandelowski,

1995). In ethnography studies, qualitative researchers often select the setting and site and then

the population and phenomenon of interest (Marshall & Rossman, 2011). In other types of

qualitative research, researchers often select the phenomenon or population of interest and then

identify potential participants for their studies. Qualitative researchers attempt to select partic-

ipants who have experience or are knowledgeable in the area of study and are willing to share

rich, in-depth information about the phenomenon, situation, culture, or event being studied.

For example, if the goal of the study is to describe the phenomenon of living with chronic

pain, the researcher will select individuals who are articulate and reflective, have a history

of chronic pain, and are willing to share their chronic pain experience (Coyne, 1997;

Munhall, 2012).

Common sampling methods used in qualitative nursing research are purposive or purposeful

sampling, network or snowball sampling, theoretical sampling, and convenience sampling

(described earlier). These sampling methods are summarized in Table 9-1. These sampling

methods enable researchers to select information-rich cases or participants who they believe will

provide them the best data for their studies. The sample selection process can have a profound

effect on the quality of the study; researchers need to describe this in enough depth to promote

interpretation of the findings and replication of the study.

Purposeful or Purposive Sampling With purposeful or purposive sampling, sometimes referred to as “judgmental” or “selective”

sampling, the researcher consciously selects certain participants, elements, events, or incidents

to include in the study. Researchers may try to include typical or atypical participants or similar

or varied situations. Qualitative researchers may select participants who are of various age cate-

gories, those who have different diagnoses or illness severity, or those who received an ineffective

rather than an effective treatment for their illness. For example, researchers describing grief fol-

lowing the loss of a child might include parents who lost a child in the previous 6, 12, and

24 months, and the children who were lost might be varying ages (<5 years old, 5 to 10 years old, and >10 years old). The ultimate goal of purposeful sampling is selecting information-rich cases from which researchers can obtain in-depth information needed for their studies.

Some have criticized the purposeful sampling method because it is difficult to evaluate the accu-

racy or relevance of the researcher’s judgment. Therefore researchers must indicate the character-

istics that they desired in study participants and provide a rationale for selecting these types of

individuals to obtain essential data for their study. In qualitative studies, purposive sampling seems

the best way to gain insights into a new area of study, discover new meaning, or obtain in-depth

understanding of a complex experience, situation, or event (Fawcett & Garity, 2009; Marshall &

Rossman, 2011; Munhall, 2012).

270 CHAPTER 9 Examining Populations and Samples in Research

Network Sampling Network sampling, sometimes referred to as “snowball,” “chain,” or “nominated” sampling holds

promise for locating participants who would be difficult or impossible to obtain in other ways or

who have not been previously identified for study (Marshall & Rossman, 2011; Munhall, 2012).

Network sampling takes advantage of social networks and the fact that friends tend to have

characteristics in common. This strategy is also particularly useful for finding subjects in socially

devalued populations, such as persons who are dependent on alcohol, abuse children, commit

sexual offenses, are addicted to drugs, or commit criminal acts. These persons seldom are willing

to make themselves known. Other groups, such as widows, grieving siblings, or persons successful

at lifestyle changes, also may be located using network sampling. They are typically outside the

existing healthcare system and are difficult to find. When researchers have found a few participants

RESEARCH EXAMPLE

Purposeful or Purposive Sampling

Research Excerpt Lapidus-Graham (2012) conducted a phenomenological study to describe the lived experience of participation in

student nursing associations (SNAs) by students in New York. This researcher used purposive sampling to select her

study participants.

“The purposive sample consisted of 15 nursing graduates from five Long Island nursing programs who were

members of a SNA within the past five years.. . . Former nursing students were chosen from the downstate

Long Island area via contact with faculty SNA advisors and through input from nursing department chairs. It

was determined from the sample that only one of the five schools required mandatory membership in the

SNA. The participants ranged in age from approximately 21 to 50 years and included two male and 13 female

students.” (Lapidus-Graham, 2012, p. 7)

Critical Appraisal Lapidus-Graham (2012) clearly identified the use of a purposive sampling method to select the 15 participants for

her study. Using purposive sampling, she was able to obtain participants from five different settings. The students

were a broad age range and included males and females, which increased the richness of the data collected. During

data analysis, the final themes were determined only after 12 or more of the participants had described an experience

related to a specific concept or idea. The purposive sampling method using SNA advisors and nursing department

chairs seemed to identify participants who were rich with information about SNA. In addition, the sample size

seemed adequate to provide rich, quality data for this study.

Implications for Practice Lapidus-Graham (2012) identified the themes generated by the study, implications for practice, and recommenda-

tions for further research in the following study excerpt.

“Six themes of the lived experiences of the participants in SNA emerged: (1) leadership: communication, collab-

oration, and resolving conflict; (2) mentoring and mutual support; (3) empowerment and ability to change practice;

(4) professionalism; (5) sense of teamwork; and (6) accountability and responsibility. Recommendations from the

study included an orientation and mentoring of new students to the SNA by senior students and faculty. Addition-

ally nursing faculty could integrate SNA activities within the classroom and clinical settings to increase the awareness

of the benefits of participation in a student nursing organization. Recommendations for future research include a

different sample and use of different research designs” (Lapidus-Graham, 2012, p. 4).

The QSEN (2013) implications from this study are that participation in SNAs provides experiences in teamwork,

collaboration, and leadership, which are important competencies for delivering quality, safe, patient-centered care

in nursing.

271CHAPTER 9 Examining Populations and Samples in Research

who meet the sampling criteria, they ask for their assistance in finding others with similar

characteristics.

Researchers often obtain the first few study participants through a purposeful sampling method

and expand the sample size using network sampling. This sampling method is used in quantitative

studies but is more common in qualitative studies. In qualitative research, network sampling is an

effective strategy for identifying subjects who can provide the greatest insight and essential infor-

mation about an experience or event that is being studied. For example, if a study were being con-

ducted to describe the lives of adolescents who are abusing substances, network sampling would

enable researchers to find participants who have a prolonged history of substance abuse and who

could provide rich information about their lives in an interview (Fawcett & Garity, 2009).

RESEARCH EXAMPLE

Network Sampling

Research Excerpt Milroy, Wyrick, Bibeau, Strack, and Davis (2012) conducted an exploratory-descriptive qualitative study to inves-

tigate student physical activity promotion on college campuses. The study included 14 of 15 (93%) universities

recruited, and 22 employees from these universities participated in the study interviews. Milroy and colleagues

(2012) implemented purposive and snowball (network) sampling to recruit individuals into their study and

described their sampling process in the following excerpt:

“Participants were recruited from a southeastern state university system [study settings].. . . Initially, non-

probabilistic purposive sampling [sampling method] was used to identify one potential participant from

each university. Individuals selected for recruitment were identified to be most likely responsible for student

physical activity promotion [study participants].. . . Snowball sampling [sampling method] followed the non-

probabilistic purposive sampling to identify additional individuals on each campus who were engaged in

promoting physical activity to students. Guidelines of snowball sampling prescribe that each interview par-

ticipant be asked to identify any other individuals on their campus who are also responsible for promoting

physical activity to students. Using snowball sampling helps to reduce the likelihood of omitting key partic-

ipants. This technique was initiated during each interview until all those responsible for student physical activ-

ity promotion on each campus were identified and interviewed.” (Milroy et al., 2012, p. 306)

Critical Appraisal Milroy and associates (2012) clearly identified that the focus of their purposive sample was to obtain study partic-

ipants who had extensive experience with and knowledge of the study topic. The rationale for using snowball sam-

pling was described, and the process for implementing it was detailed. The study was conducted in multiple settings

with knowledgeable participants who provided in-depth information about the health promotion physical activities

on university campuses. The researchers indicated that they continued snowball sampling until all those responsible

for student physical activity promotion on the different campuses were identified and interviewed. This study dem-

onstrates a quality sampling process for addressing the study purpose.

Implications for Practice Milroy and co-workers (2012) concluded that great efforts were put forth to encourage students to attend fitness

classes or join incentive programs, but the students’ involvement in physical activities was limited. Thus new

methods are needed to promote physical activity on college campuses, and the administration is important in cre-

ating a culture that supports and values physical activity. Milroy and colleagues (2012, p. 305) recommended that

“replication of this study is needed to compare these findings with other types of universities, and to investigate the

relationship between promotion of activities (type and exposure) and physical activity behaviors of college

students.”

272 CHAPTER 9 Examining Populations and Samples in Research

Theoretical Sampling Theoretical sampling is used in qualitative research to develop a selected theory through the

research process (Munhall, 2012). This type of sampling strategy is used most frequently with

grounded theory research, because the focus of this type of research is theory development.

The researcher gathers data from any person or group who is able to provide relevant, varied,

and rich information for theory generation. The data are considered relevant and rich if they

include information that generates, delimits, and saturates the theoretical codes in the study

needed for theory generation (Huberman & Miles, 2002). A code is saturated if it is complete

and the researcher can see how it fits in the theory. The researcher continues to seek sources

and gather data until the codes are saturated, and the theory evolves from the codes and data.

Diversity in the sample is encouraged so that the theory developed covers a wide range of behaviors

in varied situations and settings (Munhall, 2012; Strauss & Corbin, 1998).

RESEARCH EXAMPLE

Theoretical Sampling

Research Excerpt Beaulieu, Kools, Kennedy, and Humphreys (2011, p. 41) conducted a qualitative study using grounded theory

methods to “explore and better understand the reasons for the apparent underuse of emergency contraceptive pills

(ECPs) in young people in coupled relationships.” These researchers applied three sampling methods: (1) conve-

nience sampling, (2) snowball sampling, and (3) theoretical sampling. They described their sampling methods in the

following study excerpt:

“A convenience sample was recruited via public notices and snowball sampling [sampling methods]. Inclu-

sion criteria were women 18 to 25 years of age, English speaking, with basic knowledge of ECPs, and cur-

rently involved in a sexual relationship with a partner who was also willing to participate in the study.. .

Analysis began simultaneously with data collection as dictated by the tenets of grounded theory. The initial

analysis of interviews and filed notes consisted of strategies of open coding and memoing (Glaser & Strauss,

1967). . .. As new categories emerged, the original interview guide was revised and additional couples were

recruited to allow for theoretical sampling [sampling method]—that is, sampling specifically to fill in theoret-

ical gaps, strengthen categories and their relationships, and verify or challenge emerging conceptualizations

(Strauss & Corbin, 1998) and forced coding.” (Beaulieu et al., 2011, p. 43)

Critical Appraisal Beaulieu and associates (2011) clearly identified their sampling methods that were appropriate for a qualitative

study conducted with grounded theory methodology. Both convenience and snowball sampling methods were

applied since the researchers wanted an adequate number of couples to participate in their study and discuss

the decision making regarding ECPs. Beaulieu and co-workers (2011) also provided detailed rationale for their

use of theoretical sampling to develop a theory about young couples’decision making related to ECPs. The sampling

methods provided a quality sample of 22 couples, who provided the essential information for grounded theory

development. The number of participants allowed a broader view of the use of ECP, a complex and sensitive topic.

More details on this study are presented later in this chapter in the discussion of sample size in qualitative studies.

Implications for Practice Beaulieu and colleagues (2011) discussed the following implications for practice based on their study findings:

“Nurses whose practice includes young people, especially young women, need to be aware of possible cou-

ple dynamics when discussing contraception. Clinicians should first assess the characteristics of the relation-

ship before trying to involve the partner. Those young women who exhibit a capacity for intimacy and are in

supportive relationships should be encouraged to engage in open communications with their partners about

their contraception needs, including possible ECP use.” (Beaulieu et al., 2011, p. 47)

They also recommended that further research should include more diverse groups, as well as couples who were not

in agreement regarding the use of ECP.

273CHAPTER 9 Examining Populations and Samples in Research

SAMPLE SIZE IN QUALITATIVE STUDIES

In quantitative research, the sample size must be large enough to identify relationships among vari-

ables or determine differences between groups. The larger the sample size and effect size, the

greater the power to detect relationships and differences in quantitative and outcomes studies.

However, qualitative research focuses on the quality of information obtained from the person, sit-

uation, or event sampled, rather than on the size of the sample (Creswell, 2014; Huberman & Miles,

2002; Munhall, 2012; Sandelowski, 1995).

The purpose of the study determines the sampling plan and initial sample size. The depth of

information that is obtained and needed to gain insight into a phenomenon, describe a cultural

element, develop a theory, describe an important healthcare concept or issue, or understand a his-

torical event determines the final number of people, sites, artifacts, or documents sampled. Morse

(2000) refers to this as intraproject sampling, or the additional sampling that is done during data

collection and analysis to promote the development of quality study findings. The sample size can

be too small when the data collected lack adequate depth or richness, and an inadequate sample

size can reduce the quality and credibility of the research findings.

The number of participants in a qualitative study is adequate when saturation and verifi-

cation of information are achieved in the study area. Saturation of study data occurs

when additional sampling provides no new information, only redundancy of previous col-

lected data. Verification of study data occurs when researchers are able to confirm hunches,

relationships, or theoretical models further. With grounded theory research, “sampling for

verification occurs when linkages are made between categories and/or concepts in the devel-

oping analysis. In other words, as theory emerges, data collection continues” (Morse, 2007,

p. 537). The theory linkages developed need to be based on data, regardless of how abstract

they are. Important factors that need to be considered in determining sample size are (1)

scope of the study, (2) nature of the topic, (3) quality of the data, and (4) design of the study

(Morse, 2000, 2007; Munhall, 2012).

Scope of the Study If the scope of the study is broad, researchers will need extensive data to address the study

purpose, and it will take longer to reach saturation. Therefore a study with a broad scope

requires more sampling of participants, events, or documents than what is needed for a study

with a narrow scope (Morse, 2000). For example, a qualitative study of the experience of living

with chronic illness in older adulthood would require a large sample because of the broad

scope of the problem. A study that has a clear purpose and provides focused data collection

usually has richer, more credible findings. In contrast to the study of chronic illness experi-

ences of older adults, researchers exploring the lived experience of adults older than 70 years

who have rheumatoid arthritis could obtain credible findings with a smaller sample. When

critically appraising a qualitative study, determine whether the sample size was adequate

for the identified scope of the study.

Nature of the Topic If the topic of study is clear and easily discussed by the subjects, then fewer subjects are needed to

obtain the essential data. If the topic is difficult to define and awkward for people to discuss, then

more participants are often needed to achieve data saturation (Morse, 2000; Munhall, 2012). For

example, a phenomenological study of the experience of an adult living with a history of child

274 CHAPTER 9 Examining Populations and Samples in Research

sexual abuse is a very sensitive, complex topic to investigate. This type of topic probably will

require increased participants and interview time to collect essential data. When critically apprais-

ing published studies, be sure to consider whether the sample size was adequate based on the com-

plexity and sensitivity of the topic studied.

Quality of the Information The quality of information obtained from an interview, observation, or document review influ-

ences the sample size. When the quality of the data is high, with a rich content, few participants

are needed to achieve saturation of data in the area of study. Quality data are best obtained from

articulate, well-informed, and communicative participants (Munhall, 2012; Sandelowski, 1995).

Such participants are able to share richer data in a clear and concise manner. In addition, partic-

ipants who have more time to be interviewed usually provide data with greater depth and breadth.

The researchers will continue sampling until saturation and verification of data are achieved to

produce the best study results. Remember to consider these factors in your critical appraisal of

a qualitative study:

• The quality of the information available from the participants, events, or documents

• The richness of the data collected

• The adequacy of the sample based on the findings obtained

Study Design Some studies are designed to increase the number of interviews with each participant. When

researchers conduct multiple interviews with a person, they probably will collect higher quality,

richer data. For example, with a study design that includes an interview before and after an

event, more data are produced than with a single-interview design. Designs that involve inter-

viewing families usually produce more data than designs with single-participant interviews

(Munhall, 2012).

? CRITICAL APPRAISAL GUIDELINES Adequacy of the Sampling Processes in Qualitative Studies

When critically appraising the sampling processes in qualitative studies, you need to address the following

questions:

1. Is the sampling plan adequate to address the purpose of the study? If purposive sampling is used, does the

researcher provide a rationale for the sample selection process? If network or snowball sampling is used, does

the researcher identify the networks used to obtain the sample and provide a rationale for their selection? If

theoretical sampling is used, does the researcher indicate how participants are selected to promote the gen-

eration of a theory?

2. Are the sampling criteria identified?

3. Does the researcher identify the study setting and discuss the entry into the setting?

4. Does the researcher discuss the quality of the data provided by the study participants? Were the participants

articulate, well informed, and willing to share information relevant to the study topic?

5. Did the sampling process produce saturation and verification of data in the area of the study?

6. Is the sample size adequate based on the scope of the study, nature of the topic, quality of the data, and study

design?

275CHAPTER 9 Examining Populations and Samples in Research

RESEARCH SETTINGS

The research setting is the site or location used to conduct a study. Three common settings for

conducting nursing studies are natural, partially controlled, and highly controlled (Grove et al.,

2013). Chapter 2 initially introduced the types of settings for quantitative research. Some studies

are strengthened by having more than one setting, making the sample more representative of the

target population. The selection of a setting in quantitative and qualitative research is based on the

purpose of the study, accessibility of the setting(s) or site(s), and number and type of participants

RESEARCH EXAMPLE

Qualitative Study Sample

Research Excerpt Beaulieu and associates (2011) conducted a grounded theory study that was introduced earlier in the discussion of

theoretical sampling. This study focused on developing a theory about young adult couples’decision making regard-

ing their use of emergency contraceptive pills (ECPs). The sample was obtained with convenience, snowball, and

theoretical sampling and resulted in a sample size of 22 couples. The following study excerpt provides the

researchers’ rationale for the final sample size of their study:

“A convenience sample was recruited via public notices and snowball sampling.. . . All interested young

women initiated the first contact with the researcher by e-mail or telephone.. . . At the first meeting, which

also included partners, study procedures were reviewed with participants, after which written consent and

demographic information were obtained.. . .

Analysis began simultaneously with data collection as dictated by the tenets of grounded theory.. . . As

these processes progressed, axial coding was performed to identify core categories and their relationships.

As new categories emerged, the original interview guide was revised and additional couples were recruited

to allow for theoretical sampling—that is, sampling specifically to fill in theoretical gaps, strengthen catego-

ries and their relationships, and verify or challenge emerging conceptualizations (Strauss & Corbin, 1998) and

focused coding.. . . Member checking occurred throughout the analysis by sharing the preliminary findings

with subsequent couples to meet the requirements of confirmability of developing conceptualizations.. . .

Saturation—when no new categories emerge (Strauss & Corbin, 1998)—was reached after interviewing

18 couples, but five more couples were included to ensure comprehensive analysis as well as theoretical

verification. As the analysis continued through the processes of grounded theorizing, salient categories con-

sistent with contemporary grounded theory principles were constructed to characterize the experience of

young couples regarding ECPs.” (Beaulieu et al., 2011, p. 43)

Critical Appraisal Beaulieu and co-workers’ (2011) study has many strengths in the area of sampling, including quality sampling

methods (convenience, snowball, and theoretical), conscientious, information-rich participants, and robust sample

size (N¼22 couples), which allowed for multiple perspectives on ECP use. The researchers provided extensive details of the theoretical sampling conducted to ensure saturation was achieved, with no new categories emerging.

The saturation occurred after 18 couples but the researchers interviewed five more couples to ensure depth and

breadth in the data for theoretical verification. They described how they were able to successfully develop a theo-

retical model of young couples’ experiences regarding ECPs. The study would have been strengthened by knowing

how many study participants were obtained by each of the sampling methods (convenience, snowball, and theo-

retical). Also, the researchers mentioned that saturation was obtained with 18 couples but five more couples were

included, or N¼23, but the sample size identified was N¼22. A rationale is needed for the attrition of one of the couples from the study.

Implications for Practice The implications for practice for the Beaulieu and colleagues’ (2011) study were presented earlier in this chapter in

the section on theoretical sampling.

276 CHAPTER 9 Examining Populations and Samples in Research

or subjects available in the settings. The setting needs to be clearly described in the research report,

with a rationale for selecting it. If the setting is partially or highly controlled, researchers should

include a discussion of how they manipulated the setting. The following sections describe the three

types of research settings, with examples provided from some of the studies discussed earlier.

Natural Setting A natural or field setting is an uncontrolled, real-life situation or environment. Conducting a

study in a natural setting means that the researcher does not manipulate or change the environ-

ment for the study. Descriptive and correlational quantitative studies and qualitative studies are

often conducted in natural settings.

Partially Controlled Setting A partially controlled setting is an environment that is manipulated or modified in some way by the

researcher. An increasing number of nursing studies, usually correlational, quasi-experimental, and

experimental studies, are being conducted in partially controlled settings. Manipulation of a study

environmentisveryuncommoninqualitativeresearch;however,qualitativeresearchersmightmanip-

ulate a setting to promote the most effective environment to obtain the information that they need.

RESEARCH EXAMPLE

Natural Setting

Research Excerpt Beaulieu and associates (2011) conducted a grounded theory study to describe young adult couples’ decision mak-

ing regarding the use of ECPs (see earlier). The researchers conducted their study in natural settings that were con-

venient for the study participants. “The study design included three semistructured interviews conducted with each

couple-dyad; individual interviews were scheduled consecutively, lasting 30 to 45 minutes, and a 45- to 60-minute

couple interview was scheduled approximately 1 week later. The interviews took place in various public settings or

the couples’ homes” (Beaulieu et al., 2011, p. 43).

Critical Appraisal Beaulieu and co-workers (2011) clearly described their natural study settings, which were selected for the conve-

nience of the study participants. These settings were natural, with no attempts by the researchers to manipulate

the settings. The three interviews (for each study participant and as a couple) were scheduled at a time and place

that facilitated the involvement of the participants in the study. Because of the sensitive nature of the topic, it was

important to make the participants as comfortable as possible.

RESEARCH EXAMPLE

Partially Controlled Setting

Research Excerpt Giakoumidakis and colleagues (2013) used a partially controlled setting to conduct their randomized quasi-

experimental trial of the effects of intensive glycemic control on the outcomes of cardiac surgery patients. The study

was conducted over 5 months, from September 2011 to January 2012, in an eight-bed cardiac surgery ICU in a

general hospital. The structure of the ICU environment enabled the researchers to implement the treatment of

an insulin infusion protocol to tightly control the experimental subjects’ blood glucose level (120 to 160 mg/dL).

Critical Appraisal This partially controlled environment made it possible to collect data consistently and accurately on the outcome

variables of mortality, length of ICU stay, length of postoperative hospital stay, duration of tracheal intubation, pres-

ence of severe hypoglycemia events, and incidence of postoperative infections.

277CHAPTER 9 Examining Populations and Samples in Research

Highly Controlled Setting A highly controlled setting is an artificially constructed environment developed for the sole pur-

pose of conducting research. Laboratories, research or experimental centers, and test units in hos-

pitals or other healthcare agencies are highly controlled settings in which experimental studies

often are conducted. This type of setting reduces the influence of extraneous variables, which

enables researchers to examine the effects of independent variables on dependent variables

accurately.

K E Y C O N C E P T S

• Sampling involves selecting a group of people, events, behaviors, or other elements to study.

• Sampling theory was developed to determine the most effective way of acquiring a sample that

accurately reflects the population under study.

• Important sampling theory concepts include population, sampling criteria, target population,

accessible population, study elements, representativeness, randomization, sampling frame, and

sampling method or plan.

RESEARCH EXAMPLE

Highly Controlled Setting

Research Excerpt Sharma, Ryals, Gajewski, and Wright (2010) conducted an experimental study of the effects of aerobic exercise on

analgesia and neurotrophin-3 (NT-3) synthesis in an animal model of chronic widespread pain. The aim of this

study was to gain a cellular understanding of the impact of aerobic exercise on chronic pain to increase the under-

standing of the impact of exercise on the chronic pain of fibromyalgia (FM) patients. This study was conducted in a

laboratory setting; the setting is briefly described in the following excerpt:

“All experiments were approved by the Institutional Animal Care and Use Committee of the University of

Kansas Medical Center and adhered to the university’s animal care guidelines. Forty CF-1 female mice

(weight¼25 g) were used to examine the effects of moderately intense exercise on primary (muscular) and secondary (cutaneous) hyperalgesia and NT-3 synthesis. Because women develop widespread pain syn-

dromes at a greater rate than age-matched men, hyperalgesia was induced in female mice. The mice were

exposed to 12-hour light/dark cycle and had access to food and water ad libitum. The mice received two 20-ml injections of either acidic saline. . . or normal saline. . . 2 days apart into the right gastrocnemius muscle to

induce chronic widespread hyperalgesia or pain-like behavior.” (Sharma et al., 2010, p. 715)

Critical Appraisal Sharma and associates (2010) used a highly controlled laboratory setting in their study in terms of the housing of the

mice, light and temperature of the environment, implementation of the treatments, and measurements of the

dependent variables. This type of setting control can only be achieved with animals, and the researchers documented

that the animals were treated humanely, according to national guidelines. This type of highly controlled setting

removes the impact of numerous extraneous variables, so that the researchers can clearly determine the effects

of the independent variables on the dependent variables.

Implications for Practice This experimental study provides basic knowledge about the biological processes of mice exposed to chronic pain

and provides a basis for applied human research to examine the effects of aerobic exercise on chronic widespread

pain, such as the pain experienced by FM patients. Because this study was conducted on animals, the findings cannot

be generalized to humans, and additional research is needed to determine the effects of the independent variables on

the dependent variables in clinical settings.

278 CHAPTER 9 Examining Populations and Samples in Research

• In quantitative research, a sampling plan is developed to increase representativeness of the tar-

get population and decrease systematic bias and sampling error.

• In qualitative research, a sampling plan is developed to increase representativeness of the find-

ings related to the phenomenon, processes, or cultural elements being studied.

• The two main types of sampling plans are probability and nonprobability.

• The common probability sampling methods used in nursing research include simple random

sampling, stratified random sampling, cluster sampling, and systematic sampling.

• The five nonprobability sampling methods discussed in this chapter are convenience sampling,

quota sampling, purposeful or purposive sampling, network sampling, and theoretical

sampling.

• Convenience sampling is used frequently in quantitative, qualitative, and outcomes studies.

• Quota sampling is used more commonly in quantitative and outcomes research and rarely in

qualitative research.

• Purposive, network, and theoretical sampling are used more often in qualitative research.

• Factors to consider in making decisions about sample size in quantitative studies include the

type of study, number of variables, sensitivity of measurement methods, data analysis tech-

niques, and expected effect size.

• Power analysis is an effective way to determine an adequate sample size for quantitative and

outcomes studies. In power analysis, effect size, level of significance (alpha¼0.05), and stan- dard power (0.8, or 80%) are used to determine sample size for a prospective study and evaluate

the sample size of a completed study.

• The number of participants in a qualitative study is adequate when saturation and verification

of data are achieved in the study area.

• Important factors to consider in determining sample size for qualitative studies include (1)

scope of the study, (2) nature of the topic, (3) quality of the data collected, and (4) design

of the study.

• Three common settings for conducting nursing research are natural, partially controlled, and

highly controlled.

REFERENCES

Aberson, C. L. (2010). Applied power analysis for the

behavioral sciences. New York: Routledge Taylor &

Francis Group.

Beaulieu, R., Kools, S. M., Kennedy, H. P., & Humphreys, J.

(2011). Young adult couples’ decision making

regarding emergency contraceptive pills. Journal of

Nursing Scholarship, 43(1), 41–48.

Botman, S. L., Moore, T. F., Moriarty, C. L., & Parsons, V.

L. (2000). Design and estimation for the National

Health Interview Survey, 1995-2004. National Center

for Health Statistics, Vital Health Statistics, Series 2, No.

130, 1–32.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Cohen, J. (1988). Statistical power analysis for the behavioral

sciences (2nd ed.). New York: Academic Press.

CONSORT Group. (2010). CONSORT statement.

Retrieved March 29, 2013 from, http://www.consort-

statement.org/consort-statement.

Coyne, I. T. (1997). Sampling in qualitative research.

Purposeful and theoretical sampling: Merging or clear

boundaries. Journal of Advanced Nursing, 26(3),

623–630.

Creswell, J. W. (2014). Research design: Qualitative,

quantitative, and mixed methods approaches (3rd ed.).

Thousand Oaks, CA: Sage.

De Silva, J., Hanwella, R., & de Silva, V. A. (2012). Direct

and indirect cost of schizophrenia in outpatients

treated in a tertiary care psychiatry unit. Ceylon

Medical Journal, 57(1), 14–18.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia: F. A.

Davis.

279CHAPTER 9 Examining Populations and Samples in Research

Fouladbakhsh, J. M., & Stommel, M. (2010). Gender,

symptom experience, and use of complementary and

alternative medicine practices among cancer survivors

in the U.S. cancer population. Oncology Nursing Forum,

37(1), E7–E15. http://dx.doi.org/10.1188/10.ONR.E7-

E15.

Giakoumidakis, K., Eltheni, R., Patelarou, E.,

Theologou, S., Patris, V., Michopanou, N., et al. (2013).

Effects of intensive glycemic control on outcomes of

cardiac surgery. Heart & Lung, 42(2), 146–151.

Glaser, B. G., & Strauss, A. L. (1967). The discovery of

grounded theory: Strategies for qualitative research.

Chicago: Aldine.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis: Elsevier Saunders.

Hodgins, M. J., Ouellet, L. L., Pond, S., Knorr, S., &

Geldart, G. (2008). Effect of telephone follow-up on

surgical orthopedic recovery. Applied Nursing Research,

21(4), 218–226.

Huberman, A. M., & Miles, M. B. (2002). The qualitative

researcher’s companion. Thousand Oaks, CA: Sage.

Kerlinger, F. N., & Lee, H. B. (2000). Foundations of

behavioral research. New York: Harcourt Brace.

Kraemer, H. C., & Theimann, S. (1987). How many

subjects? Statistical power analysis in research. Newbury

Park, CA: Sage.

Lapidus-Graham, J. (2012). The lived experience of

participation in student nursing associations and

leadership behaviors: A phenomenological study.

Journal of the New York State Nurses Association, 43(1),

4–12.

Lee, S., Faucett, J., Gillen, M., Krause, N., & Landry, L.

(2013). Risk perception of musculoskeletal injury

among critical care nurses. Nursing Research, 62(1),

36–44.

Long, J. D., Boswell, C., Rogers, T. J., Littlefield, L. A.,

Estep, G., Shriver, B. J., et al. (2013). Effectiveness of cell

phones and mypyramidtracker.gov to estimate fruit

and vegetable intake. Applied Nursing Research, 26(1),

17–23.

Marshall, C., & Rossman, G. B. (2011). Designing

qualitative research (5th ed.). Los Angeles: Sage.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-

based practice in nursing & healthcare: A guide to best

practice (2nd ed.). Philadelphia: Lippincott, Williams,

& Wilkins.

Milroy, J. H., Wyrick, D. L., Bibeau, D. L., Strack, R. W., &

Davis, P. G. (2012). A university system-wide

qualitative investigation into student physical activity

promotion conducted on college campuses. American

Journal of Health Promotion, 26(5), 305–312.

Monroe, T. B., Kenaga, H., Dietrich, M. S., Carter, M. A., &

Cowan, R. L. (2013). The prevalence of employed

nurses identified or enrolled in substance use

monitoring programs. Nursing Research, 62(1), 10–15.

Morse, J. M. (2000). Determining sample size. Qualitative

Health Research, 10(1), 3–5.

Morse, J. M. (2007). Strategies of intraproject sampling. In

P. L. Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 529–539) (4th ed.). Sudbury, MA:

Jones & Bartlett.

Munhall, P. L. (2012). Nursing research: A qualitative

perspective (5th ed.). Sudbury, MA: Jones & Bartlett

Learning.

Parent, N., & Hanley, J. A. (2009). Assessing quality of

reports on randomized clinical trials in nursing

journals. Canadian Journal of Cardiovascular Nursing,

19(2), 25–31.

Pieper, B., Templin, T. N., Kirsner, R. S., & Birk, T. J.

(2010). The impact of vascular leg disorders on

physical activity in methadone-maintained adults.

Research in Nursing & Health, 33(5), 426–440.

Quality and Safety Education for Nurses (QSEN), (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved February 11, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas.

Sandelowski, M. (1995). Focus on qualitative methods:

Sample size in qualitative research. Research in Nursing

& Health, 18(2), 179–183.

Sharma, N. K., Ryals, J. M., Gajewski, B. J., & Wright, D. E.

(2010). Aerobic exercise alters analgesia and

neurotrophin-3 synthesis in an animal model of

chronic widespread pain. Physical Therapy, 90(5),

714–725.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Strauss, A., & Corbin, J. (1998). Basics of qualitative

research, techniques, and procedures for developing

grounded theory (2nd ed.). Thousand Oaks, CA: Sage.

Toma, L. M., Houck, G. M., Wagnild, G. M., Messecar, D.,

& Jones, K. D. (2013). Growing old with fibromyalgia.

Nursing Research, 62(1), 16–24.

280 CHAPTER 9 Examining Populations and Samples in Research

C H A P T E R

10 Clarifying Measurement and Data Collection

in Quantitative Research

C H A P T E R OV E R V I E W

Concepts of Measurement Theory, 283

Directness of Measurement, 283

Levels of Measurement, 284

Measurement Error, 286

Reliability, 287

Validity, 290

Accuracy, Precision, and Error of Physiological

Measures, 292

Accuracy, 292

Precision, 292

Error, 293

Use of Sensitivity, Specificity, and Likelihood

Ratios to Determine the Quality of Diagnostic

and Screening Tests, 295

Sensitivity and Specificity, 295

Likelihood Ratios, 298

Measurement Strategies in Nursing, 298

Physiological Measures, 298

Observational Measurement, 300

Interviews, 302

Questionnaires, 304

Scales, 306

Data Collection Process, 310

Recruitment of Study Participants, 310

Consistency in Data Collection, 310

Control in the Study Design, 311

Studies Obtaining Data from Existing

Databases, 311

Key Concepts, 313

References, 314

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Describe measurement theory and its relevant

concepts of directness of measurement,

levels of measurement, measurement error,

reliability, and validity.

2. Determine the levels of measurement—nominal,

ordinal, interval, and ratio—achieved by

measurement methods in published studies.

3. Identify possible sources of measurement error

in published studies.

4. Critically appraise the reliability and validity

of measurement methods in published

studies.

5. Critically appraise the accuracy, precision, and

error of physiological measures used in studies.

6. Critically appraise the sensitivity, specificity, and

likelihood ratios of diagnostic tests.

7. Critically appraise the measurement

approaches—physiological measures,

observations, interviews, questionnaires, and

scales—used in published studies.

8. Critically appraise the use of existing databases in

studies.

9. Critically appraise the data collection section in

published studies.

281

K E Y T E R M S

Accuracy, p. 292

Accuracy of a screening test,

p. 295

Administrative data, p. 311

Alternate forms reliability,

p. 290

Construct validity, p. 291

Content validity, p. 291

Data collection, p. 310

Direct measures, p. 283

Equivalence, p. 290

Error in physiological measures,

p. 293

Evidence of validity from

contrasting groups, p. 291

Evidence of validity from

convergence, p. 291

Evidence of validity from

divergence, p. 291

False negative, p. 295

False positive, p. 295

Gold standard, p. 295

Highly sensitive test, p. 296

Highly specific test, p. 296

Homogeneity, p. 290

Indirect measures, or

indicators, p. 283

Internal consistency, p. 290

Interrater reliability, p. 290

Interval-level measurement,

p. 285

Interview, p. 302

Levels of measurement, p. 284

Likelihood ratios, p. 298

Likert scale, p. 307

Measurement, p. 282

Measurement error, p. 286

Negative likelihood ratio, p. 298

Nominal-level measurement,

p. 284

Observational measurement,

p. 300

Ordinal-level measurement,

p. 284

Physiological measures, p. 292

Positive likelihood ratio, p. 298

Precision, p. 292

Primary data, p. 311

Questionnaire, p. 304

Random measurement error,

p. 287

Rating scales, p. 307

Ratio-level measurement, p. 286

Readability level, p. 291

Reliability, p. 287

Reliability testing, p. 288

Scale, p. 306

Secondary data, p. 311

Sensitivity, p. 296

Specificity, p. 296

Stability, p. 289

Structured interview, p. 302

Structured observational

measurement, p. 300

Systematic measurement error,

p. 287

Test-retest reliability, p. 289

True measure or score, p. 286

True negative, p. 295

True positive, p. 295

Unstructured interview, p. 302

Unstructured observations,

p. 300

Validity, p. 290

Visual analog scale, p. 308

Measurement is a very important part of the quantitative research process. When quality measure-

ment methods are used in a study, it improves the accuracy or validity of study outcomes or find-

ings. Measurement is the process of assigning numbers or values to individuals’ health status,

objects, events, or situations using a set of rules (Kaplan, 1963). For example, we measure a

patient’s blood pressure (BP) using a measurement method such as a stethoscope, cuff, and sphyg-

momanometer. Then a number or value is assigned to that patient’s BP, such as 120/80 mm Hg. In

research, variables are measured with the best possible measurement method available to produce

trustworthy data that can be used in statistical analyses. Trustworthy data are essential if a study is

to produce useful findings to guide nursing practice (Brown, 2014; Fawcett & Garity, 2009).

In critically appraising studies, you need to judge the trustworthiness of the measurement

methods used. To produce trustworthy measurements, rules have been established to ensure that

numbers, values, or categories will be assigned consistently from one subject (or event) to another

and, eventually, if the measurement method or strategy is found to be meaningful, from one study

to another. The rules of measurement established for research are similar to those used in nursing

practice. For example, measuring a BP requires that the patient be allowed to rest for 5 minutes and

then should be sitting, legs uncrossed, arm relaxed on a table at heart level, cuff of accurate size

282 CHAPTER 10 Clarifying Measurement and Data Collection

placed correctly on the upper arm that is free of restrictive clothing, and stethoscope correctly

placed over the brachial artery at the elbow. Following these rules ensures that the patient’s BP

is accurately and precisely measured and that any change in the BP reading can be attributed

to a change in BP, rather than to an inadvertent error in the measurement technique.

Understanding the logic of measurement is important for critically appraising the adequacy of

measurement methods in nursing studies. This chapter includes a discussion of the key concepts of

measurement theory—directness of measurement, levels of measurement, measurement error,

reliability, and validity. The accuracy and precision of physiological measures and sensitivity

and specificity of diagnostic and screening tests are also addressed. Some of the most common

measurement methods or strategies used in nursing research are briefly described. The chapter

concludes with guidelines for critically appraising the data collection processes used in studies.

CONCEPTS OF MEASUREMENT THEORY

Measurement theory guides the development and use of measurement methods or tools in

research. Measurement theory was developed many years ago by mathematicians, statisticians,

and other scholars and includes rules that guide how things are measured (Kaplan, 1963). These

rules allow individuals to be consistent in how they perform measurements; thus a measurement

method used by one person will consistently produce similar results when used by another person.

This section discusses some of the basic concepts and rules of measurement theory, including

directness of measurement, levels of measurement, measurement error, reliability, and validity.

Directness of Measurement To measure, the researcher must first identify the object, characteristic, element, event, or situation

to be measured. In some cases, identifying the object to measure and determining how to measure

it are quite simple, such as when the researcher measures a person’s weight and height. These are

referred to as direct measures. Direct measures involve determining the value of concrete factors

such as weight, waist circumference, temperature, heart rate, BP, and respiration. Technology is

available to measure many bodily functions, biological indicators, and chemical characteristics.

The focus of measurement in these instances is on the accuracy and precision of the measurement

method and process. If a patient’s BP is to be accurate, it must be measured with a quality stetho-

scope and sphygmomanometer and must be precisely or consistently measured, as discussed ear-

lier in the introduction. In research, three BP measurements are usually taken and averaged to

determine the most accurate and precise BP reading. Nurse researchers are also experienced in

gathering direct measures of demographic variables such as age, gender, ethnic origin, and

diagnosis.

However, in many cases in nursing, the thing to be measured is not a concrete object but an

abstract idea, characteristic, or concept such as pain, stress, caring, coping, depression, anxiety,

and adherence. Researchers cannot directly measure an abstract idea, but they can capture some

of its elements in their measurements, which are referred to as indirect measures or indicators of

the concepts. Rarely, if ever, can a single measurement strategy measure all aspects of an abstract

concept. Therefore multiple measurement methods or indicators are needed, and even then they

cannot be expected to measure all elements of an abstract concept. For example, multiple measure-

ment methods might be used to describe pain in a study, which decreases the measurement error

and increases the understanding of pain. The measurement methods of pain might include the

FACES Pain Scale, observation (rubbing and/or guarding the area that hurts, facial grimacing,

and crying), and physiological measures, such as pulse and blood pressure. Figure 10-1

283CHAPTER 10 Clarifying Measurement and Data Collection

demonstrates multiple measures of the concept of pain and demonstrates how having more

measurement methods increases the understanding of the concept. The bold, black-rimmed

largest circle represents the concept of pain and the pale-colored smaller circles represent

the measurement methods. A larger circle is represented by physiological measures indicating

these measures (pulse, blood pressure, and respirations) add more to the objective measure-

ment of pain. Even with three different types of measurement methods being used, the entire

concept of pain is not completely measured, as indicated by the white areas within the black-

rimmed large circle.

Levels of Measurement Various measurement methods produce data that are at different levels of measurement. The tra-

ditional levels of measurement were developed by Stevens (1946), who organized the rules for

assigning numbers to objects so that a hierarchy in measurement was established. The levels of

measurement, from low to high, are nominal, ordinal, interval, and ratio.

Nominal-Level Measurement Nominal-level measurement is the lowest of the four measurement categories. It is used when data

can be organized into categories of a defined property but the categories cannot be rank-ordered.

For example, you may decide to categorize potential study subjects by diagnosis. However, the cat-

egory “kidney stone,” for example, cannot be rated higher than the category “gastric ulcer”; sim-

ilarly, across categories, “ovarian cyst” is no closer to “kidney stone” than to “gastric ulcer.” The

categories differ in quality but not quantity. Therefore, it is not possible to say that subject A pos-

sesses more of the property being categorized than subject B. (RULE: The categories must not be

orderable.) Categories must be established in such a way that each datum will fit into only one of

the categories. (RULE: The categories must be exclusive.) All the data must fit into the established

categories. (RULE: The categories must be exhaustive.) Data such as gender, race and ethnicity, mar-

ital status, and diagnoses are examples of nominal data. The rules for the four levels of measure-

ment are summarized in Figure 10-2.

Ordinal-Level Measurement With ordinal-level measurement, data are assigned to categories that can be ranked. (RULE: The

categories can be ranked [see Figure 10-2].) To rank data, one category is judged to be (or is

ranked) higher or lower, or better or worse, than another category. Rules govern how the data

Concept of Pain

FACES Pain Scale

Observation

Physiological measures

FIG 10-1 Multiple measures of the concept of pain.

284 CHAPTER 10 Clarifying Measurement and Data Collection

are ranked. As with nominal data, the categories must be exclusive (each datum fits into only one

category) and exhaustive (all data fit into at least one category). With ordinal data, the quantity

also can be identified (Stevens, 1946). For example, if you are measuring intensity of pain, you may

identify different levels of pain. You probably will develop categories that rank these different levels

of pain, such as excruciating, severe, moderate, mild, and no pain. However, in using categories of

ordinal measurement, you cannot know with certainty that the intervals between the ranked cat-

egories are equal. A greater difference may exist between mild and moderate pain, for example,

than between excruciating and severe pain. Therefore ordinal data are considered to have unequal

intervals.

Many scales used in nursing research are ordinal levels of measurement. For example, it is pos-

sible to rank degrees of coping, levels of mobility, ability to provide self-care, or levels of dyspnea

on an ordinal scale. For dyspnea with activities of daily living (ADLs), the scale could be:

0¼no shortness of breath with ADLs 1¼minimal shortness of breaths with ADLs 2¼moderate shortness of breath with ADLs 3¼extreme shortness of breath with ADLs 4¼shortness of breath so severe the person is unable to perform ADLs without assistance

The measurement is ordinal because it is not possible to claim that equal distances exist between

the rankings. A greater difference may exist between the ranks of 1 and 2 than between the ranks of

2 and 3.

Interval-Level Measurement

Interval-level measurement uses interval scales, which have equal numerical distances between

intervals. These scales follow the rules of mutually exclusive, exhaustive, and ranked categories

and are assumed to represent a continuum of values. (RULE: The categories must have equal inter-

vals between them [see Figure 10-2].) Therefore the magnitude of the attribute can be more pre-

cisely defined. However, it is not possible to provide the absolute amount of the attribute, because

the interval scale lacks a zero point. Temperature is the most commonly used example of an

Exclusive Categories

Exhaustive Categories

Nominal Ordinal Interval Ratio

Exclusive Categories

Exhaustive Categories

Ranked Categories

Exclusive Categories

Exhaustive Categories

Ranked Categories

Equal Interval

Categories

Exclusive Categories

Exhaustive Categories

Ranked Categories

Equal Interval

Categories

Absolute Zero

FIG 10-2 Summary of the Rules for Levels of Measurement.

285CHAPTER 10 Clarifying Measurement and Data Collection

interval scale. The difference between the temperatures of 70� F and 80� F is 10� F and is the same as the difference between the temperatures of 30� F and 40� F. Changes in temperature can be mea- sured precisely. However, a temperature of 0� F does not indicate the absence of temperature.

Ratio-Level Measurement

Ratio-level measurement is the highest form of measurement and meets all the rules of other

forms of measurement—mutually exclusive categories, exhaustive categories, ordered ranks,

equally spaced intervals, and a continuum of values. Interval- and ratio-level data can be added,

subtracted, multiplied, and divided because of the equal intervals and continuum of values of these

data. Thus interval and ratio data can be analyzed with statistical techniques of greater precision

and strength to determine significant relationships and differences (Grove, 2007). In addition,

ratio-level measures have absolute zero points. (RULE: The data must have absolute zero [see

Figure 10-2].) Weight, length, and volume are commonly used as examples of ratio scales. All three

have absolute zeros, at which a value of zero indicates the absence of the property being measured;

zero weight means the absence of weight. Because of the absolute zero point, such statements as

“Subject A weighs 25 more pounds than subject B” or “Medication container A holds two times as

much as container B” can be justified (Stevens, 1946).

In critically appraising a study, you need to determine the level of measurement achieved for

each measurement method. Researchers try to achieve the highest level of measurement possible

for a variable because more rigorous statistical analyses can be conducted on interval- and ratio-

level data to describe variables, determine relationships among variables, and examine differences

among groups.

Measurement Error The ideal perfect measure is referred to as the true measure or score. However, some error is always

present in any measurement strategy. Measurement error is the difference between the true mea-

sure and what is actually measured (Grove, Burns, & Gray, 2013). The amount of error in a mea-

sure varies from considerable error in one measurement to very little in another. Measurement

error exists with direct and indirect measures. With direct measures, both the object and measure-

ment method are visible. Direct measures, which generally are expected to be highly accurate, are

subject to error. For example, a weight scale may be inaccurate for 0.5 pound, precisely calibrated

BP equipment might decrease in precision with use, or a tape measure may not be held at exactly

the same tension in measuring the waist of each patient. A subject in a study may be 65 years old

but may write illegibly on the demographic form. As a result, the age may be entered inaccurately

into the study database.

With indirect measures, the element being measured cannot be seen directly. For example, you

cannot see pain. You may observe behaviors or hear words that you think represent pain, but pain

is a sensation that is not always clearly recognized or expressed by the person experiencing it. The

measurement of pain is usually conducted with a scale but can also include observation and phys-

iological measures as shown in Figure 10-1. Efforts to measure concepts such as pain usually result

in measuring only part of the concept. Sometimes measures may identify some aspects of the con-

cept but may include other elements that are not part of the concept. In Figure 10-1, the measure-

ment methods of scale, observation, and physiological measures include factors other than pain, as

indicated by the parts of the circles that are outside the black-rimmed circle of the concept pain.

For example, measurement methods for pain might be measuring aspects of anxiety and fear in

addition to pain. However, using multiple methods to measure a concept or variable usually

decreases the measurement error and increases the understanding of the concept being measured.

286 CHAPTER 10 Clarifying Measurement and Data Collection

Two types of error are of concern in measurement, random error and systematic error. The dif-

ference between random and systematic error is in the direction of the error. In random measure-

ment error, the difference between the measured value and the true value is without pattern or

direction (random). In one measurement, the actual value obtained may be lower than the true

value, whereas in the next measurement, the actual value obtained may be higher than the

true value. A number of chance situations or factors can occur during the measurement process

that can result in random error (Waltz, Strickland, & Lenz, 2010). For example, the person taking

the measurements may not use the same procedure every time, a subject completing a paper and

pencil scale may accidentally mark the wrong column, or the person entering the data into a com-

puter may punch the wrong key. The purpose of measuring is to estimate the true value, usually by

combining a number of values and calculating an average. An average value, such as the mean, is a

closer estimate of the true measurement. As the number of random errors increases, the precision

of the estimate decreases.

Measurement error that is not random is referred to as systematic error. In systematic measure-

ment error, the variation in measurement values from the calculated average is primarily in the

same direction. For example, most of the variation may be higher or lower than the average that

was calculated. Systematic error occurs because something else is being measured in addition to the

concept. For example, a paper and pencil rating scale designed to measure hope may actually also

be measuring perceived support. When measuring subjects’ weights, a scale that shows weights

that are 2 pounds over the true weights will give measures with systematic error. All the measured

weights will be high, and as a result the mean will be higher than if an accurate weight scale were

used. Some systematic error occurs in almost any measure. Because of the importance of this type

of error in a study, researchers spend considerable time and effort refining their instruments to

minimize systematic measurement error (Waltz et al., 2010).

In critically appraising a published study, you will not be able to judge the extent of measure-

ment error directly. However, you may find clues about the amount of measurement error in the

published report. For example, if the researchers have described the method of measurement in

great detail and provided evidence of accuracy and precision of the measurement, then the prob-

ability of error typically is reduced. The measurement errors for BP readings can be minimized by

checking the BP cuff and sphygmomanometer for accuracy and recalibrating them periodically

during data collection, obtaining three BP readings and averaging them to determine one BP read-

ing for each subject, and having a trained nurse using a protocol to take the BP readings. If a check-

list of pain behaviors is developed for observation, less error occurs than if the observations for

pain are unstructured. Measurement will also be more precise if researchers use a well-developed,

reliable, and valid scale, such as the FACES Pain Scale, instead of developing a new pain scale for

their study. In published studies, look for the steps that researchers have taken to decrease mea-

surement error and increase the quality of their study findings.

Reliability Reliability is concerned with the consistency of a measurement method. For example, if you are

using a paper and pencil scale to measure depression, it should indicate similar depression scores

each time a subject completes it within a short period of time. A scale that does not produce similar

scores for a subject with repeat testing is considered unreliable and results in increased measure-

ment error (Kerlinger & Lee, 2000; Waltz et al., 2010). For example, the Center for Epidemiologic

Studies Depression Scale (CES-D) was developed to diagnose depression in mental health patients

(Radloff, 1977). The CES-D has proven to be a quality measure of depression in research over the

last 40 years. Figure 10-3 illustrates this 20-item Likert scale. If the items on this scale consistently

287CHAPTER 10 Clarifying Measurement and Data Collection

measure what it was developed to measure, depression, then this scale is considered to be both

reliable and valid. The different types of reliability and validity testing are discussed in the next

sections (outlined in Table 10-1).

Reliability Testing Reliability testing is a measure of the amount of random error in the measurement technique. It

takes into account such characteristics as dependability, precision, stability, consistency, and repro-

ducibility (Grove et al., 2013; Waltz et al., 2010). Because all measurement techniques contain some

random error, reliability exists in degrees and usually is expressed as a correlation coefficient (r).

Center for Epidemiologic Studies Depression Scale DEPA

These questions are about how you have been feeling lately. As I read the following statements, please tell me how often you felt or behaved this way in the last week. (Hand card). For each statement, did you feel this way: (Interviewer: You may help respondent focus on the whichever “style” answer is easier)

0 = Rarely or none of the time (or less than 1 day)?

R S O M NR

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

I was bothered by things that usually don’t bother me.

I did not feel like eating; my appetite was poor.

I felt that I could not shake off the blues even with help from my

family and friends.

I felt that I was just as good as other people.

I had trouble keeping my mind on what I was doing.

I felt depressed.

I felt that everything I did was an effort.

I felt hopeful about the future.

I thought my life had been a failure.

I felt fearful.

My sleep was restless.

I was happy.

I talked less than usual.

I felt lonely.

People were unfriendly.

I enjoyed life.

I had crying spells.

I felt sad.

I felt people disliked me.

I could not get going.

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

1 = Some or a little of the time (or 1–2 days)?

2 = Occasionally or a moderate amount of time (or 3–4 days)?

3 = Most or all of the time (or 5–7 days)?

FIG 10-3 Center of Epidemiologic Studies Depression Scale (CES-D). (Radloff, L. S. [1977]. The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measures, 1, 385-394.)

288 CHAPTER 10 Clarifying Measurement and Data Collection

Cronbach’s alpha coefficient is the most commonly used measure of reliability for scales with mul-

tiple items (see the following discussion of homogeneity for more details). Estimates of reliability

are specific to the sample being tested. Thus high reliability values reported for an established instru-

ment do not guarantee that reliability will be satisfactory in another sample or with a different

population. Researchers need to perform reliability testing on each instrument used in a study

to ensure that it is reliable for that study (Bialocerkowski, Klupp, & Bragge, 2010; DeVon

et al., 2007).

Reliability testing focuses on the following three aspects of reliability—stability, equivalence,

and homogeneity (see Table 10-1). Stability is concerned with the consistency of repeated mea-

sures of the same attribute with the use of the same scale or instrument. It is usually referred to as

test-retest reliability. This measure of reliability is generally used with physical measures, techno-

logical measures, and paper and pencil scales. Use of the technique requires an assumption that the

factor to be measured remains the same at the two testing times and that any change in the value or

TABLE 10-1 DETERMINING THE QUALITY OF MEASUREMENT METHODS

QUALITY

INDICATOR DESCRIPTION

Reliability Test-retest reliability: Repeated measures with a scale or instrument to determine the

consistency or stability of the instrument in measuring a concept

Alternate forms reliability: Comparison of two paper and pencil instruments to determine

their equivalence in measuring a concept

Interrater reliability: Comparison of two observers or judges in a study to determine their

equivalence in making observations or judging events

Homogeneity or internal consistency reliability: Reliability testing used primarily with

multi-item scales in which each item on the scale is correlated with all other items to

determine the consistency of the scale in measuring a concept

Validity Content validity: Examines the extent to which a measurement method includes all the

major elements relevant to the concept being measured.

Evidence of validity from contrasting groups: Instrument or scale given to two groups

expected to have opposite or contrasting scores; one group scores high on the scale and

the other scores low.

Evidence of validity from convergence: Two scales measuring the same concept are

administered to a group at the same time, and the subjects’ scores on the scales should

be positively correlated. For example, subjects completing two scales to measure

depression should have positively correlated scores.

Evidence of validity from divergence: Two scales that measure opposite concepts, such

as hope and hopelessness, are administered to subjects at the same time and should

result in negatively correlated scores on the scales.

Readability Readability level: Conducted to determine the participants’ ability to read and

comprehend the items on an instrument. Researchers need to report the level of

education that subjects need to read the instrument. Readability must be appropriate to

promote reliability and validity of an instrument.

Precision Precision of physiological measure: Degree of consistency or reproducibility of the

measurements made with physiological instruments or equipment; comparable to

reliability for paper and pencil scales.

Accuracy Accuracy of physiological measure: Addresses the extent to which the physiological

instrument or equipment measures what it is supposed to measure in a study;

comparable to validity for paper and pencil scales.

289CHAPTER 10 Clarifying Measurement and Data Collection

score is a consequence of random error. For example, physiological measures such as BP equip-

ment can be tested and then immediately retested, or the equipment can be used for a time

and then retested to determine the necessary frequency of recalibration. Researchers need to

include test-retest reliability results in their published studies to document the reliability of their

measurement methods. For example, the CES-D (see Figure 10-3) has been used frequently in

nursing studies over the years and has demonstrated test-retest reliability ranging from r¼0.51 to 0.67 in 2- to 8-week intervals. This is very solid test-retest reliability for this scale, indicating

that it is consistently measuring depression with repeat testing and recognizing that subjects’ levels

of depression vary somewhat over time (Locke & Putnam, 2002; Sharp & Lipsky, 2002).

Reliability testing can also include equivalence, which involves the comparison of two versions

of the same paper and pencil instrument or of two observers measuring the same event. Compar-

ison of two observers or two judges in a study is referred to as interrater reliability. Studies that

include collecting observational data or the making of judgments by two or more data gatherers

require the reporting of interrater reliability. There is no absolute value below which interrater

reliability is unacceptable. However, any value below 0.80 should generate serious concern about

the reliability of the data, data gatherer, or both. The interrater reliability value is best to be 0.90 or

90%, which means 90% reliability and 10% random error, or higher.

Comparison of two paper and pencil instruments is referred to as alternate forms reliability, or

parallel forms reliability. Alternative forms of instruments are of more concern in the development

of normative knowledge testing such as the Scholastic Aptitude Test (SAT), which is used as a col-

lege entrance requirement. The SAT has been used for decades, and there are many forms of this

test, with a variety of items included on each. These alternate forms of the SAT were developed to

measure students’ knowledge consistently and protect the integrity of the test.

Homogeneity is a type of reliability testing used primarily with paper and pencil instruments or

scales to address the correlation of each question to the other questions within the scale. Questions

on a scale are also called items. The principle is that each item should be consistently measuring a

concept such as depression and so should be highly correlated with the other items. Homogeneity

testing examines the extent to which all the items in the instrument consistently measure the

construct and is a test of internal consistency. The statistical procedure used for this process is

Cronbach’s alpha coefficient for interval- and ratio-level data. On some scales, the person respond-

ing selects between two options, such as yes and no. The resulting data are dichotomous, and the

Kuder-Richardson formula (K-R 20) is used to estimate internal consistency. A Cronbach alpha

coefficient of 1.00 indicates perfect reliability, and a coefficient of 0.00 indicates no reliability

(Waltz et al., 2010). A reliability of 0.80 is usually considered a strong coefficient for a scale that

has documented reliability and has been used in several studies, such as the CES-D (Grove et al.,

2013; Radloff, 1977). The CES-D has strong internal consistency reliability, with Cronbach’s alphas

ranging from 0.84 to 0.90 in field studies (Locke & Putnam, 2002; Sharp & Lipsky, 2002). For rel-

atively new scales, a reliability of 0.70 is considered acceptable because the scale is being refined and

used with a variety of samples. The stronger correlation coefficients, which are closer to 1.0, indi-

cate less random error and a more reliable scale. A research report needs to include the results from

stability, equivalence, and/or homogeneity reliability testing done on a measurement method from

previous research and in the present study (Grove et al., 2013). A measurement method must be

reliable if it is to be considered a valid measure for a study concept.

Validity The validity of an instrument is a determination of how well the instrument reflects the abstract

concept being examined. Validity, like reliability, is not an all or nothing phenomenon; it is

290 CHAPTER 10 Clarifying Measurement and Data Collection

measured on a continuum. No instrument is completely valid, so researchers determine the degree

of validity of an instrument rather than whether validity exists (DeVon et al., 2007; Waltz et al.,

2010). Validity will vary from one sample to another and one situation to another; therefore valid-

ity testing evaluates the use of an instrument for a specific group or purpose, rather than the instru-

ment itself. An instrument may be valid in one situation but not another. For example, the CES-D

was developed to measure the depression of patients in mental health settings. Will the same scale

be valid as a measure of the depression of cancer patients? Researchers determine this by pilot-

testing the scale to examine the validity of the instrument in a new population. In addition,

the original CES-D (see Figure 10-3) was developed for adults, but the scale has been refined

and tested with young children (4 to 6 years of age), school-age children, adolescents, and older

adults. Thus different versions of this scale can be used with those of all ages, ranging from 4 years

old to geriatric age (Sharp & Lipsky, 2002).

In this text, validity is considered a single broad method of measurement evaluation, referred to

as construct validity, and includes content and predictive validity (Rew, Stuppy, & Becker, 1988).

Content validity examines the extent to which the measurement method or scale includes all the

major elements or items relevant to the construct being measured. The evidence for content valid-

ity of a scale includes the following: (1) how well the items of the scale reflect the description of the

concept in the literature; (2) the content experts’ evaluation of the relevance of items on the scale

that might be reported as an index (Grove et al., 2013); and (3) the potential subjects’ responses to

the scale items.

Paper and pencil and electronic instruments or scales must be at a level that potential study

subjects can read and understand. Readability level focuses on the study participants’ ability

to read and comprehend the content of an instrument or scale. Readability is essential if an instru-

ment is to be considered valid and reliable for a sample (see Table 10-1). Assessing the level of

readability of an instrument is relatively simple and takes about 10 to 15 minutes. More than

30 readability formulas are available. These formulas use counts of language elements to provide

an index of the probable degree of difficulty of comprehending the scale (Grove et al., 2013). Read-

ability formulas are now a standard part of word-processing software.

Three common types of validity presented in published studies include evidence of validity

from (1) contrasting groups, (2) convergence, and (3) divergence. An instrument’s evidence of

validity from contrasting groups can be tested by identifying groups that are expected (or known)

to have contrasting scores on an instrument. For example, researchers select samples from a group

of individuals with a diagnosis of depression and a group that does not have this diagnosis. You

would expect these two groups of individuals to have contrasting scores on the CES-D. The group

with the diagnosis of depression would be expected to have higher scores than those without the

depression diagnosis, which would add to the construct validity of this scale.

Evidence of validity from convergence is determined when a relatively new instrument is com-

pared with an existing instrument(s) that measures the same construct. The instruments, the new

and existing ones, are administered to a sample at the same time, and the results are evaluated with

correlational analyses. If the measures are strongly positively correlated, the validity of each instru-

ment is strengthened. For example, the CES-D has shown positive correlations ranging from 0.40

to 0.80 with the Hamilton Rating Scale for Depression, which supports the convergent validity of

both scales (Locke & Putnam, 2002; Sharp & Lipsky, 2002).

Sometimes instruments can be located that measure a concept opposite to the concept mea-

sured by the newly developed instrument. For example, if the newly developed instrument is a

measure of hope, you could make a search for an instrument that measures hopelessness or despair.

Having study participants complete both these scales is a way to examine evidence of validity from

291CHAPTER 10 Clarifying Measurement and Data Collection

divergence. Correlational procedures are performed with the measures of the two concepts. If the

divergent measure (hopelessness scale) is negatively correlated (such as �0.4 to �0.8) with the other instrument (hope scale), validity for each of the instruments is strengthened (Waltz

et al., 2010).

The evidence of an instrument’s validity from previous research and the current study needs to

be included in the published report. In critically appraising a study, you need to judge the validity

of the measurement methods that were used. However, you cannot consider validity apart from

reliability (see Table 10-1). If a measurement method does not have acceptable reliability or is not

consistently measuring a concept, then it is not valid.

ACCURACY, PRECISION, AND ERROR OF PHYSIOLOGICAL MEASURES

Physiological measures are measurement methods used to quantify the level of functioning of

living beings (Ryan-Wenger, 2010). The precision, accuracy, and error of physiological and bio-

chemical measures tend not to be reported or are minimally covered in published studies. These

routine physiological measures are assumed to be accurate and precise, an assumption that is not

always correct. Some of the most common physiological measures used in nursing studies include

BP, heart rate, weight, body mass index, and laboratory values. Sometimes researchers obtain these

measures from the patient’s record, with no consideration given to their accuracy. For example,

how many times have you heard a nurse ask a patient his or her height or weight, rather than mea-

suring or weighing the patient? Thus researchers using physiological measures need to provide

evidence of the measures’ accuracy, precision, and potential for error (see Table 10-1; Gift &

Soeken, 1988; Ryan-Wenger, 2010).

Accuracy Accuracy is comparable to validity in that it addresses the extent to which the instrument measures

what it is supposed to measure in a study (Ryan-Wenger, 2010). For example, oxygen saturation

measurements with pulse oximetry are considered comparable with measures of oxygen saturation

with arterial blood gases. Because pulse oximetry is an accurate measure of oxygen saturation, it

has been used in studies because it is easier, less expensive, less painful, and less invasive for

research participants. Researchers need to document that previous research has been conducted

to determine the accuracy of pulse oximetry for the measurement of individuals’ oxygen saturation

levels in their study.

Precision Precision is the degree of consistency or reproducibility of measurements made with physiological

instruments. Precision is comparable to reliability. The precision of most physiological equip-

ment depends on following the manufacturer’s instructions for care and routine testing of the

equipment. Test-retest reliability is appropriate for physiological variables that have minimal

fluctuations, such as cholesterol (lipid) levels, bone mineral density, or weight of adults (Ryan-

Wenger, 2010). Test-retest reliability can be inappropriate if the variables’ values frequently fluc-

tuate with various activities, such as with pulse, respirations, and BP. However, test-retest is a good

measure of precision if the measurements are taken in rapid succession. For example, the national

BP guidelines encourage taking three BP readings 1 to 2 minutes apart and then averaging them to

obtain the most precise and accurate measure of BP (http://www.nhlbi.nih.gov/guidelines/

hypertension).

292 CHAPTER 10 Clarifying Measurement and Data Collection

Error Sources of error in physiological measures can be grouped into the following five categories: envi-

ronment, user, subject, equipment, and interpretation. The environment affects the equipment

and subject. Environmental factors might include temperature, barometric pressure, and static

electricity. User errors are caused by the person using the equipment and may be associated with

variations by the same user, different users, or changes in supplies or procedures used to operate

the equipment. Subject errors occur when the subject alters the equipment or the equipment alters

the subject. In some cases, the equipment may not be used to its full capacity. Equipment error may

be related to calibration or the stability of the equipment. Signals transmitted from the equipment

are also a source of error and can result in misinterpretation (Gift & Soeken, 1988). Researchers

need to report the protocols followed or steps taken to prevent errors in their physiological and

biochemical measures in their published studies (Ryan-Wenger, 2010; Stone & Frazier, 2010).

? CRITICAL APPRAISAL GUIDELINES Directness, Level of Measurement, Reliability, and Validity of Scales, Accuracy, Precision, and Error of Physiological Measures

In critically appraising a published study, you need to determine the directness and level of measurement, reli-

ability and validity of scales, accuracy and precision of physiological measures, and potential measurement error

for the different measurement methods used in a study. In most studies, the methods section includes a dis-

cussion of measurement methods, and you can use the following questions to evaluate them:

1. What measurement method(s) were used to measure each study variable?

2. Was the type of measurement direct or indirect?

3. What level of measurement was achieved for each of the study variables?

4. Was reliability information provided from previous studies and for this study?

5. Was the validity of each measurement method adequately described? In some studies, researchers simply

state that the measurement method has acceptable validity based on previous research. This statement pro-

vides insufficient information for you to judge the validity of an instrument.

6. Did the researchers address the accuracy, precision, and potential for errors with the physiological measures?

7. Was the process for obtaining, scoring, and/or recording data described?

8. Did the researchers provide adequate description of the measurement methods to judge the extent of

measurement error?

RESEARCH EXAMPLE

Directness, Level of Measurement, Reliability, and Validity of Scales, Accuracy, Precision, and Error of Physiological Measures

Research Excerpt Whittenmore, Melkus, Wagner, Dziura, Northrup, and Grey (2009) studied the effects of a lifestyle change program

on the outcomes for patients with type 2 diabetes. The lifestyle program was delivered by nurse practitioners (NPs)

in primary care settings. The following excerpt describes some of the measurement methods used in this study.

Outcome Measures

“Data were collected at the individual (participant) and organizational (NP and site) levels at scheduled time

points throughout the study. . . . All data were collected by trained research assistants blinded to group

assignment, with the exception of . . . lipids, which were collected by experienced laboratory personnel at

each site and sent to one laboratory for analysis.” (Whittenmore et al., 2009, p. 5) Continued

293CHAPTER 10 Clarifying Measurement and Data Collection

RESEARCH EXAMPLE—cont’d

“Efficacy data were collected on clinical outcomes on (weight loss, waist circumference, and lipid pro-

files); behavioral outcomes (nutrition and exercise); and psychological outcomes (depressive symptoms). . . .

All data were collected at baseline, 3 months, and 6 months, with the exception of the laboratory data, which

were collected at baseline and 6 months. . . . Efficacy data collection measures and times were based on the

DPP [diabetes prevention program] study and modified for the short duration of this pilot study.

Weight loss was the primary outcome and was calculated as a percentage of weight loss from baseline

to 6 months. . . . Waist circumference and lipid profiles were secondary clinical outcomes. Waist circumfer-

ence was measured by positioning a tape measure snugly midway between the upper hip bone and the

uppermost border of the iliac crest. In very overweight participants, the tape was placed at the level of

the umbilicus (Klein et al., 2007). Lipid profiles (LDL [low-density lipoproteins], HDL [high-density lipopro-

teins], total cholesterol, and total triglycerides) were determined using fasting venous blood.

Diet and exercise health-promoting behaviors were measured with the exercise and nutrition subscales

of the Health-Promoting Lifestyle Profile II (eight and nine items, respectively), which has items constructed

on a 4-point Likert scale and measures patterns of diet and exercise behavior (Walker, Sechrist, & Pender,

1987). This instrument has been used in diverse samples, and demonstrates adequate internal consistency

(r¼.70 to .90 for subscales; Jefferson, Melkus, & Spollett, 2000). The alpha coefficients for the exercise and nutrition subscales in this study were .86 and .76, respectively. . . .

Psychosocial data were collected on depressive symptoms, as measured by the Center for Epidemio-

logic Studies Depression Scale (CES-D), a widely used scale (Radloff, 1977). The CES-D consists of 20 items

that address depressed mood, guilt or worthlessness, helplessness or hopelessness, psychomotor retarda-

tion, loss of appetite, and sleep disturbance [see Figure 10-3]. Each item is rated on a scale of 0 to 3 in terms of

frequency during the past week. The total score may range from 0 to 60, with a score of 16 or more indicating

impairment. High internal consistency, acceptable test-retest reliability, and good construct validity have

been demonstrated (Posner et al., 2001). The alpha coefficient was .93 for the CES-D in this sample.”

(Whittenmore et al., 2009, p. 6)

Critical Appraisal Whittenmore and colleagues (2009) detailed their measurement methods and data collection process in their

research report. The outcomes of weight loss, waist circumference, and lipid profiles were measured directly with

physiological measures that provided ratio-level data. Weight loss was calculated as a percentage, but the researchers

did not describe the precision and accuracy of the weight scales used to determine the patients’ weights. Waist cir-

cumference was measured with a tape measure according to national guidelines and included a plan for measuring

very overweight individuals. Following a national measurement protocol increased the precision and accuracy of the

waist measurements and decreased the potential for error. The subjects’ blood samples were collected by experienced

laboratory personnel at each site and sent to one laboratory for analysis, which increases the precision and accuracy

of the lipid values.

Diet and exercise health-promoting behaviors were measured with the subscales from an established, quality Likert

scale, Health-Promoting Lifestyle Profile II. The subscales had strong reliability (r¼0.70 to 0.90) when used in pre- vious research and the reliability for the subscales in this study were strong (0.86 for diet and 0.76 for exercise). The

Health-Promoting Lifestyle Profile II has been used to collect data from diverse samples, which adds to the scale

validity. However, the discussion of this measurement method would have been strengthened by expanding on

the scale’s validity testing from previous studies.

The CES-D is an indirect measure of depression producing interval-level data. This scale has been widely used in

research, which adds to its construct validity. The researchers also identified the focus of the 20 items of the scale,

which addresses the scale’s content validity. The scale was reported to have good construct validity but no further

specific information was provided to support this statement. The CES-D has a history of acceptable test-retest

reliability and high internal consistency. In addition, the Cronbach alpha coefficient for this sample was very strong,

at r ¼ 0.93.

294 CHAPTER 10 Clarifying Measurement and Data Collection

USE OF SENSITIVITY, SPECIFICITY, AND LIKELIHOOD RATIOS TO DETERMINE THE QUALITY OF DIAGNOSTIC AND SCREENING TESTS

Sensitivity and Specificity

An important part of evidence-based practice (EBP) is the use of quality diagnostic and screening

tests to determine the presence or absence of disease (Sackett, Straus, Richardson, Rosenberg, &

Haynes, 2000). Clinicians want to know which laboratory or imaging study to order to help screen

for or diagnose a disease. When the test is ordered, are the results valid or accurate? The accuracy of

a screening test or a test used to confirm a diagnosis is evaluated in terms of its ability to assess the

presence or absence of a disease or condition correctly as compared with a gold standard. The gold

standard is the most accurate means of currently diagnosing a particular disease and serves as a

basis for comparison with newly developed diagnostic or screening tests. If the test is positive, what

is the probability that the disease is present? If the test is negative, what is the probability that the

disease is not present? When nurses, nurse practitioners, and physicians talk to their patients about

the results of their tests, how sure are they that the patient does or does not have the disease? Sen-

sitivity and specificity are the terms used to describe the accuracy of a screening or diagnostic test.

You will see these terms used in studies and other healthcare literature, and we want you to be

aware of their definitions and usefulness for practice and research.

There are four possible outcomes of a screening test for a disease: (1) true positive, which is an

accurate identification of the presence of a disease; (2) false positive, which indicates that a disease

is present when it is not; (3) true negative, which indicates accurately that a disease is not present;

or (4) false negative, which indicates that a disease is not present when it is. Table 10-2 is com-

monly used to visualize sensitivity, specificity, and these four outcomes (Grove, 2007; Melnyk &

Fineout-Overholt, 2011; Sackett et al., 2000).

You can calculate sensitivity and specificity based on research findings and clinical practice out-

comes to determine the most accurate diagnostic or screening tool to use when identifying the

presence or absence of a disease for a population of patients. The calculations for sensitivity

and specificity are provided as follows:

The research assistants were trained and blinded to group assignment, decreasing the potential for error and bias

during data collection. However, the study would have been strengthened by including the interrater reliability per-

centage achieved during the training of the data collectors. In summary, Whittenmore and associates (2009) selected

quality measurement methods that were consistently implemented. However, expanding the validity discussions of

the scales used would have strengthened the study.

Implications for Practice Whittenmore and co-workers (2009) stated that

“the results of this study support the feasibility of implementing a DPP by NPs in a primary care setting to

adults at risk of T2D [type 2 diabetes]. . . . Preliminary efficacy results of the lifestyle program indicate modest

improvements with respect to clinical and behavioral outcomes. Twenty-five percent of the lifestyle partic-

ipants achieved a 5% weight loss goal compared with 11% of participants in standard care.” (Whittenmore

et al., 2009, pp. 8-9)

The study results indicated that the lifestyle program was effective for the target population of adults at risk for

T2D. Further research is needed, however, to determine the long-term effects of such a program. These study find-

ings provide knowledge to help you achieve the Quality and Safety Education for Nurses (QSEN, 2013; Sherwood &

Barnsteiner, 2012) competencies for evidence-based practice (EBP) for prelicensure nursing students. Research indi-

cates that this patient-centered lifestyle program has the potential to improve the outcomes of patients with T2D.

295CHAPTER 10 Clarifying Measurement and Data Collection

Sensitivity calculation ¼ probability of disease ¼ a= a + cð Þ ¼ true positive rate Specificity calculation ¼ probability of no disease ¼ d= b + dð Þ ¼ true negative rate

Sensitivity is the proportion of patients with the disease who have a positive test result, or true

positive. The CES-D (see Figure 10-3) with a score of 15 or higher has 89% sensitivity for diag-

nosing depression in adults and 92% sensitivity in older adults. The researcher or clinician might

refer to the test sensitivity in the following ways:

• A highly sensitive test is very good at identifying the disease in a patient.

• If a test is highly sensitive, it has a low percentage of false negatives.

Specificity is the proportion of patients without the disease who have a negative test result, or

true negative. The CES-D with a score of 15 or higher has 70% specificity for diagnosing depression

in adults and 87% specificity in older adults. The researcher or clinician might refer to the test

specificity in the following ways:

• A highly specific test is very good at identifying the patients without a disease.

• If a test is very specific, it has a low percentage of false positives.

TABLE 10-2 RESULTS OF SENSITIVITY AND SPECIFICITY OF SCREENING TESTS

DIAGNOSTIC TEST RESULT DISEASE PRESENT DISEASE NOT PRESENT OR ABSENT TOTAL

Positive test a (true positive) b (false positive) a+b

Negative test c (false negative) d (true negative) c+d

Total a+c b+d a+b+c+d

a, Number of people who have the disease and the test is positive (true positive); b, number of people who do not have the

disease and the test is positive (false positive); c, number of people who have the disease and the test is negative (false

negative); d, number of people who do not have the disease and the test is negative (true negative).

From Grove, S. K. (2007). Statistics for health care research: A practical workbook (p. 335). Philadelphia: Saunders.

? CRITICAL APPRAISAL GUIDELINES Sensitivity and Specificity of Diagnostic and Screening Tests

When critically appraising a study, you need to judge the sensitivity and specificity of the diagnostic and screen-

ing tests used in the study.

1. Was a diagnostic or screening test used in a study?

2. Are the sensitivity and specificity values provided for the diagnostic or screening test from previous studies

and for this study’s population?

RESEARCH EXAMPLE

Sensitivity and Specificity

Research Excerpt Sarikaya, Aktas, Ay, Cetin, and Celikmen (2010) conducted a study to determine the sensitivity and specificity of the

rapid antigen detection testing for diagnosing pharyngitis in emergency department (ED) patients. Acute pharyn-

gitis is primarily a viral infection, but in 10% of cases it is caused by bacteria. Most of the bacterial pharyngitis cases

are caused by group A beta-hemolytic streptococci (GABHS). One laboratory method for diagnosing GABHS is

296 CHAPTER 10 Clarifying Measurement and Data Collection

rapid antigen diagnostic testing (RADT), which has become more popular than a throat culture because it can be

processed rapidly during an ED and primary care visit. The following study excerpt describes the quality of the

RADT in this sample:

“We conducted a study to define the sensitivity and specificity of RADT, using throat culture results as the

gold standard, in 100 emergency department patients who presented with symptoms consistent with strep-

tococcal pharyngitis. We found that RADT had a sensitivity of 68.2% (15 of 22), a specificity of 89.7% (70 of

78), a positive predictive value of 65.2% (15 of 23), and a negative predictive value of 90.9% (70 of 77).”

(Sarikaya, et al., p. 180)

The results of Sarikaya and colleagues’ (2010) study are shown in Table 10-3, so you can see how the sensitivity and

specificity were calculated.

Sensitivitycalculation ¼ probability of disease ¼ a= a + cð Þ ¼true-positiverate Sensitivity ¼ probability of GABHS pharyngitis ¼ 15= 15 + 7ð Þ ¼ 15=22 ¼ 68:18% ¼ 68:2% Specificity calculation ¼ probability of nodisease ¼d= b + dð Þ ¼ true negativerate

Specificity ¼ probability of noGABHS pharyngitis ¼ 70= 8 + 70ð Þ ¼ 70=78 ¼ 89:74% ¼ 89:7% The sensitivity of 68.2% indicates the percentage of patients with a positive RADT who had GABHS pharyngitis

(true positive rate). The specificity of 89.7% indicates the percentage of the patients with a negative RADTwho did

not have GABHS pharyngitis (true negative rate).

Critical Appraisal Sarikaya and associates (2010) provided a quality discussion about sensitivity and specificity of RADT in identifying

GABHS pharyngitis in ED patients. They detailed sensitivity and specificity information in their narrative and in

a table.

Implications for Practice Sarikaya and co-workers (2010, p. 180) concluded that “RADT is useful in the ED when the clinical suspicion is

GABHS pharyngitis, but results should be confirmed with a throat culture in patients whose RADTresults are neg-

ative.” In developing a diagnostic or screening test, researchers need to achieve the highest sensitivity and specificity

possible. In selecting screening tests to diagnose illnesses, clinicians need to determine the most sensitive and specific

screening test but also need to examine cost and ease of access to these tests when making their final decision for

practice (Craig & Smyth, 2012).

TABLE 10-3 RESULTS OF SENSITIVITY AND SPECIFICITY OF RAPID ANTIGEN DIAGNOSTIC TESTING (RADT)

RADT DIAGNOSTIC

TEST RESULT

GABHS PHARYNGITIS

PRESENT

GABHS PHARYNGITIS

ABSENT TOTAL

Positive a (true positive)¼15 b (false positive)¼8 a+b¼15+8¼23 Negative c (false negative) ¼7 d (true negative)¼70 c+d¼7+70¼77 Total a+c¼15+7¼22 b+d¼8+70¼78 a+b+c+d¼100

a, Number of people who have group A beta-hemolytic streptococci (GABHS) pharyngitis and the test is positive (true

positive); b, number of people who do not have GABHS pharyngitis and the test is positive (false positive); c, number of

people who have GABHS pharyngitis and the test is negative (false negative); d, number of people who do not have

GABHS pharyngitis and the test is negative (true negative).

297CHAPTER 10 Clarifying Measurement and Data Collection

Likelihood Ratios Likelihood ratios (LRs) are additional calculations that can help researchers determine the

accuracy of diagnostic or screening tests, which are based on the sensitivity and specificity results.

The LRs are calculated to determine the likelihood that a positive test result is a true positive and

that a negative test result is a true negative. The ratio of the true-positive results to false-positive

results is known as the positive likelihood ratio (Campo, Shiyko, & Lichtman, 2010; Craig &

Smyth, 2012). The positive LR is calculated as follows, using the data from the Sarikaya et al.

(2010) study:

Positive LR ¼ sensitivity� 100%�specificityÞð Positive LR for GABHSpharyngitis ¼ 68:2%� 100%�89:7%ð Þ ¼ 68:2%�10:3% ¼ 6:62 The negative likelihood ratio is the ratio of true-negative results to false-negative results and is

calculated as follows:

NegativeLR ¼ 100%�sensitivityÞ�specificityð Negative LR for GABHS pharyngitis ¼ 100%�68:2%ð Þ�89:7% ¼ 31:8%�89:7% ¼ 0:35 The very high LRs (or those that are >10) rule in the disease or indicate that the patient has the

disease. The very low LRs (or those that are <0.1) almost rule out the chance that the patient has the disease (Campo et al., 2010; Melnyk & Fineout-Overholt, 2011). Understanding sensitivity,

specificity, and LR increases your ability to read clinical studies and determine the most accurate

diagnostic test to use in clinical practice.

MEASUREMENT STRATEGIES IN NURSING

Nursing studies examine a wide variety of phenomena and thus require an extensive array of mea-

surement methods. Some nursing phenomena have not been examined because no one has

thought of a way to measure them, which has implications for clinical practice and research.

This section describes some of the most common measurement methods used in nursing research,

including physiological measures, observational measurement, interviews, questionnaires, and

scales.

Physiological Measures Some of the first physiological nursing studies examined basic care activities, such as mouth care,

pressure ulcer care, and infection control related to urinary bladder catheterization, intravenous

therapy, and tracheotomy care. Even at this fairly basic level, developing valid methods to measure

the variables of interest was difficult and required considerable time and expense. Creativity and

attention to detail are also important for the development of physiological measures currently used

in research and practice (Ryan-Wenger, 2010).

An increased need for ways to measure the outcomes of nursing care has generated more nurs-

ing studies that include physiological measures. The outcome of interest may be the outcome of all

nursing care received for a particular care episode or the outcome of a particular nursing inter-

vention. An important focus of physiological measurement is finding a means to quantify changes,

directly or indirectly, that occur in physiological variables as a result of nursing care. This upsurge

of interest in outcome measures has broadened the base of physiological research beyond nurse

physiologists to include nurse clinicians (Brown, 2014; Doran, 2011).

298 CHAPTER 10 Clarifying Measurement and Data Collection

A variety of approaches for obtaining physiological measures are possible. Some measurements

are relatively easy to obtain and are an extension of the measurement methods used in nursing

practice, such as those used to obtain weight and BP. Other measurements are not difficult

to obtain, but the methods sometimes require an imaginative approach. For example, some

physiological measures are obtained by using self-report with diaries, scales, or observation

checklists, and other physiological measures are obtained using laboratory tests and electronic

monitoring.

The availability of electronic monitoring equipment has greatly increased the possibilities of

physiological measurement in nursing studies, particularly in critical care environments. Elec-

tronic monitoring requires placing sensors on or within the subject, such as electrocardiogram

leads and arterial lines. The sensors measure changes in bodily functions, such as electrical energy.

Some electronic equipment provides simultaneous recording of multiple physiological measures

that are displayed on a monitor, such as equipment that records BP, pulse, heart rhythm, and

arterial pressure. The equipment is often linked to a computer, which allows review and analysis

of the complex data (Pugh & DeKeyser, 1995; Stone & Frazier, 2010).

RESEARCH EXAMPLE

Physiological Measures

Research Excerpt Lu, Lin, Chen, Tsang, and Su (2013) conducted a quasi-experimental study to determine the effect of acupressure on

the sleep quality of psychogeriatric inpatients. Acupressure was performed for each study participant in the psychi-

atric hospital’s examination room. Sleep quality was measured indirectly or subjectively by the patients’ self-report

of their sleep and directly or objectively using actigraphy, a method that uses an electronic device to detect and

record movement. The following study excerpt describes these two types of physiological measures:

“Sleep quality was assessed subjectively and objectively. Subjective data were measured by the PSQI [Pitts-

burg Sleep Quality Index] developed by Buysse, Reynolds, Monk, Berman, and Kupfer (1989). The PSQI is a

19-item questionnaire used to measure sleep quality and disturbances for the previous 4 weeks leading up to

administration. Seven component scores (sleep latency, sleep duration, habitual sleep efficiency, sleep dis-

turbances, the use of sleeping medications, daytime dysfunction, and perceived sleep quality) are generated

and are summed to yield one global score. The higher the score is, the worse the sleep quality. The sensitivity

and specificity of a global score over 5 (poor sleeper) is 90% and 87%, respectively (Buysse et al., 1989).” (Lu

et al., 2013, p. 132)

The PSQI has documented reliability and validity from previous studies and the internal consistency for this

sample was Cronbach’s a ¼ 0.87. “Objective data were measured using actigraphy (Lenience No.: 019678), a standardized, noninvasive,

ambulatory device equipped with a sensor (piezoelectric accelerometer) that is worn by participants to mon-

itor and record gross motor activities continuously over an extended period of time. Actigraphy is useful to

assess sleep-wake cycles and circadian rhythms and offers reliable results with an average accuracy over

90%, which approximates that of the polysomnography. . . Participants wore the device all day, every day

for 4 weeks, except when showering. The participant elected to wear the device on either the nondominant

wrist or ankle. To enhance the data accuracy and prevent the device from being incidentally dislodged, an

external wrapper was used during the wearing. Data were read, transferred, stored, and analyzed using Acti-

Web software. . . . [T]he actigraphical data were translated into meaningful information used to assess the

participants’ sleep latency, total sleep time, sleep efficiency, number of sleep interruptions (wake episodes),

and minutes of wake time after the onset of sleep.” (Lu et al., 2013, pp. 132-133) Continued

299CHAPTER 10 Clarifying Measurement and Data Collection

Observational Measurement Observational measurement involves an interaction between the study participants and observer(s),

inwhich the observerhas the opportunity towatch the participant perform in a specificsetting(Waltz

et al., 2010). Observation is often used to collect data in qualitative studies, and it is usually unstruc-

tured (see Chapter 3). Unstructured observations involve spontaneously observing and recording

what is seen in words. The analysis of these data may lead to a more structured observation and an

observational checklist (Creswell, 2014; Marshall & Rossman, 2011; Munhall, 2012).

In structured observational measurement, the researcher carefully defines what he or she will

observe and how the observations are to be made, recorded, and coded as numbers (Waltz et al.,

2010). For observations to be structured, researchers will develop a category system for organizing

and sorting the behaviors or events being observed. Checklists are often used to indicate whether a

behavior occurred. Rating scales allow the observer to rate the behavior or event. This provides

more information for analysis than dichotomous data, which indicate only whether or not the

behavior occurred. Because observation tends to be more subjective than other types of measure-

ment, it is often considered less credible. In many cases, observation may be the only approach for

obtaining important data for nursing’s body of knowledge. As with any means of measurement,

consistency is very important. As a result, reporting interrater reliability of those doing the

observations is essential.

RESEARCH EXAMPLE—cont’d

Critical Appraisal Lu and colleagues (2013) used two strong physiological measures of self-report (PSQI) and electronic monitoring

(actigraphy) to measure their dependent variable of sleep quality. The PSQI has strong sensitivity (90%) and spec-

ificity (87%) in determining sleep problems and was reliable in this sample (Cronbach’s a ¼ 0.87). The discussion of this scale would have been strengthened by providing reliability and validity information from previous studies

(Waltz et al., 2010). The actigraphy used to electronically monitor sleep activities was described in detail. The

researchers compared this device to the polysomnography and indicated that it was 90% as accurate. When wearing

the device, the participants took actions to promote the accuracy and precision of the data. The processes for trans-

ferring and analyzing the data were also detailed, indicating that the results were strong in describing sleep quality,

with limited potential for measurement error.

Implications for Practice Lu and associates (2013) found that sleep quality was significantly improved after acupressure, as measured by PSQI

and actigraphy. Because acupressure is noninvasive, low-risk, and low cost, the researchers recommended that it

might be an effective intervention to treat insomnia. QSEN implications indicate that acupressure might be a safer,

evidence-based intervention to use to promote sleep than hypnotic agents for the psychogeriatic inpatient. This type

of research-based knowledge is essential for the delivery of EBP (QSEN, 2013; Sherwood & Barnsteiner, 2012).

? CRITICAL APPRAISAL GUIDELINES Observational Measurement

When critically appraising observational measures, consider the following questions:

1. Is the object of observation clearly identified and defined?

2. Are the techniques for recording observations described?

3. Is interrater reliability for the observers described?

300 CHAPTER 10 Clarifying Measurement and Data Collection

RESEARCH EXAMPLE

Observational Measurement

Research Excerpt Liaw, Yang, Chang, Chou, and Chao (2009) conducted a study to determine the effects of an educational program

for nurses in a neonatal unit on how to provide developmental supportive care (DSC) to preterm infants during

bathing. They provided an extensive description of their use of observational measurement to identify infant and

nurse behaviors during the bathing process. The following excerpt includes part of their description of their obser-

vational measurement methods:

“Nurse caregiving and infant behaviors were measured from the time that a nurse put her hands through an

isolette porthole to the stage when she completed the bath and removed her hands from an incubator and left.

Researchers developed two coding schemes: one was the preterm infant behavioral coding scheme for asses-

sing preterm infant behavior responses during bath, and the other one was the nursing behavioral coding

scheme for assessing nurse caregiving behavior during bath. The behaviors included in this coding scheme

were only those that could be reliably recorded and observed from videotapes and with which another expert

(Dr. Evelyn Thoman) agreed as being behaviors and states that could be consistently observed on video record-

ings [see Table 10-4]. Time-triggered coding was used to measure all behaviors and states. There were four

observers watching the videotapes. Two were responsible for recording infant behavior, and the other two

observed nurse behavior. All behavior data were coded at 10-second intervals on a continuous basis with

an electronic auditory device, and codes were typed in a Microsoft Word file. “(Liaw et al., 2009, pp. 87-88)

Continued

TABLE 10-4 DEFINITIONS OF INFANT BEHAVIORS AND CODES FOR SCORING VIDEOTAPES

BEHAVIOR CODE DEFINITION

Startle J Sudden movement in which the arms extend quickly outward and then return

toward midline: leg may flex or extend

Jerk J Sudden movement of at least a whole limb, one arm, or one leg

Tremor J Fine rhythmic movement of the extremities

Extension S Stiff extensor positioning of extremities—salute, airplane, sitting on air, leg

bracing, or other hypertonic behaviors

Arching S Movement of all limbs and trunk showing labored stretching and struggling

Squirming S Truncal extension into an arch or head extension in prone, supine, or upright

position

Finger splay H Sudden stiff extension of fingers and hand

Grasping H Grasping movement, with hands directed at baby’s own face or baby’s own body,

at midair, or a caregiver’s hands, finger, or body, tubing, or bedding

Fisting H Strong hand holding by flexing the baby’s fingers and forming a fist

Grimace G Cry face or frown

Sucking K Infant sucks on one’s own hands, fingers, swabs, or pacifier (although coders

cannot see the baby’s face, it is assumed that the baby is sucking)

Unknown D It is not known whether the eyes are open or closed because the coder cannot see

the baby’s eyes for the whole epoch.

Eyes closed C Eyes are closed during all 10 seconds or at any time during the epoch that the

baby’s eyes can be seen.

Eyes open O Eyes are open at any time during the 10 seconds.

Fussing or

crying

F Intermittent fussy or sustained vocal sound of distress

From Liaw, J., Yang, L., Chang, L., Chou, H., & Chao, S. (2009). Improving neonatal caregiving through a

developmentally supportive care training program. Applied Nursing Research, 22(2), 88.

301CHAPTER 10 Clarifying Measurement and Data Collection

Interviews An interview involves verbal communication between the researcher and subject, during which

information is provided to the researcher. Although this data collection strategy is most commonly

used in qualitative and descriptive studies, it also can be used in other types of quantitative studies.

You can use a variety of approaches to conduct an interview, ranging from a totally unstructured

interview (see Chapter 3), in which the content is controlled by the study participant, to a struc-

tured interview, in which the content is similar to that of a questionnaire, with the possible

responses to questions carefully designed by the researcher (Creswell, 2014; Waltz et al., 2010).

During structured interviews, researchers use strategies to control the content of the interview.

Usually, researchers ask specific questions and enter the participant’s responses onto a rating scale

RESEARCH EXAMPLE—cont’d

“Validity and Reliability

The preterm infant behaviors included in this study have been studied in other reports (Becker et al., 1999;

Peters, 1998). Researchers have reported that stress behaviors, such as finger splay, leg extension, and gri-

mace, are significantly related to ongoing caregiving procedures (Peters, 1998). . . . These studies are cited as

evidence to support validity of the behaviors included in this study. . . . Selected nurse caregiving behaviors

are based on the concepts and principles of DSC from the literature (Als, 1999; Als et al., 2003; Becker et al.,

1999). Moreover, these behaviors have also been tested in other studies and could refer to behaviors that

have been found to be key components of DSC. Some negative nursing behaviors, such as inappropriate

position and exposure to light, which often occurred during real bathing procedures, were also included.

Interrater reliability was examined by two observers through video observations and coding. Thirty

tapes were randomly selected and scored. Pearson correlation coefficients were used to calculate interrater

reliability between the observers’ scores. Correlation coefficients of the infant behavioral coding scheme

between two observers ranged from 0.82 to 0.99, and correlation coefficients of the nursing behavior coding

scheme between the other two scorers were from 0.91 to 0.98.” (Liaw et al., 2009, pp. 88-89)

Critical Appraisal Liaw and co-workers (2009) provided an excellent description of the observations to be recorded and the process for

recoding them by the observers. The coding and recoding processes were very structured to improve the validity and

reliability of the observations made in the study. They provided two tables that documented the behaviors observed

and the codes used when reviewing the videotapes of the infants and nurses (see Table 10-4 for the infant behaviors

and codes). The behaviors selected for coding were based on previous research, which strengthens the validity of the

observation measures for infant and nurse. The study included two observers coding the preterm infant behaviors

from a video, and they had very strong interrater reliability (0.82 to 0.99). The interrater reliability for the two

observers for the nurse behaviors was also very strong, with coefficients ranging from 0.91 to 0.98. In summary,

Liaw and colleagues (2009) provided a quality description of the highly valid and reliable observation methods used

in their study.

Implications for Practice Liaw and associates (2009) found that the infants were less stressed and the nurses were more supportive following

their DSC training. The researchers identified the following implications for practice:

“Preterm infants need gentle and sensitive care to support the healthy development of their body systems,

especially the brain. To significantly improve nurses’ caregiving skills, they need to initially receive DSC train-

ing and to repeat the training at regular intervals—about twice a year.” (Liaw et al., 2009, p. 91)

The researchers also recommended that additional studies be conducted to extend the DSC- type training to other

nursing caregiving activities for neonates. QSEN (2013) implications are that critically appraising studies promotes

EBP and the delivery of safe, patient-centered care to neonates.

302 CHAPTER 10 Clarifying Measurement and Data Collection

or paper and pencil instrument during the interview. For example, researchers could use an

in-person or telephone interview to obtain responses to an instrument. Researchers might also

enter responses into an electronic database.

Because nurses frequently use interviewing techniques in nursing assessment, the dynamics of

interviewing are familiar. However, using the technique for measurement in research requires

greater sophistication and needs to be discussed in the study’s methods section. The response rate

for interviews is higher than for questionnaires, which usually allows a more representative sample

to be obtained. Interviewing also allows collection of data from participants who are unable or

unlikely to complete questionnaires, such as those who are very ill or may have limited ability

to read, write, and express themselves. Interviews are a form of self-report, and it must be assumed

that the information provided is accurate. Because of time and cost, sample size is usually limited.

Participant bias is always a threat to the validity of the findings, as is inconsistency in data

collection from one subject to another (Waltz et al., 2010).

? CRITICAL APPRAISAL GUIDELINES Structured Interviews

When critically appraising interviews conducted in studies, you need to consider the following questions:

1. For structured interviews, what guided the interview process?

2. Are the interview questions relevant for the research purpose?

3. Does the design indicate the process for conducting the interviews?

4. If multiple interviewers are used to gather data, how were these individuals trained, and what consistency

was achieved for the interview process?

5. Do the questions tend to bias subjects’ responses?

RESEARCH EXAMPLE

Structured Interview

Research Excerpt Dickson, Buck, and Riegel (2013) used a structured interview format to determine the comorbid conditions of a

sample of patients with heart failure (HF). The focus of the study was to examine how multiple comorbid conditions

challenge HF patients’ self-care. The following excerpt describes the structured interview process used in this study.

“The interview format of the Charlson Comorbidity Index (CCI) was used to gather data about comorbid con-

ditions (Charlson, Pompei, Ales, & MacKenzie, 1987). Participants were asked about preexisting diseases (e.g.,

diabetes), most of which are scored with 1 point, although some (e.g., cirrhosis) are assigned >1 point. Scores

on the CCI can range from 0 to 34, with each study participant having a score�1 because of the HF. Responses were summed, weighted, and indexed into one of three categories: 0-1¼ low, 2-3¼moderate, and �4¼high, according to the published methods.. . .The ability of the CCI to predict mortality, complications, acute care

resource use, length of hospital stay, discharge disposition, and cost (Charlson et al., 1987) provide evidence

for the criterion-related validity.” (Dickson et al., 2013, p. 4)

Critical Appraisal Dickson and co-workers (2013) clearly identified the CCI as the structure for their interviews with HF patients. The

interview process seemed to be consistently implemented and produced a score for each HF patient, who was then

assigned to a low, moderate, or high category for comorbid conditions. The CCI had criterion-related validity and Continued

303CHAPTER 10 Clarifying Measurement and Data Collection

Questionnaires A questionnaire is a self-report form designed to elicit information through written, verbal, or

electronic responses of the subject. Questionnaires may be printed and distributed in person or

mailed, available on a computer, or accessed online. Questionnaires are sometimes referred to

as surveys, and a study using a questionnaire may be referred to as survey research. The informa-

tion obtained from questionnaires is similar to that obtained by an interview, but the questions

tend to have less depth. The subject is not permitted to elaborate on responses or ask for clarifi-

cation of questions, and the data collector cannot use probing strategies. However, questions are

presented in a consistent manner to each subject, and opportunity for bias is less than in an

interview.

Questionnaires often are used in descriptive studies to gather a broad spectrum of information

from subjects, such as facts about the subject or facts about persons, events, or situations known by

the subject. It is also used to gather information about beliefs, attitudes, opinions, knowledge, or

intentions of the subjects. Questionnaires are often developed for a particular study to enable

researchers to gather data from a selected population in a new area of study. Like interviews, ques-

tionnaires can have various structures. Some questionnaires have open-ended questions, which

require written responses (qualitative data) from the subject. Other questionnaires have closed-

ended questions, which have limited options from which participants can select their answers.

Although you can distribute questionnaires to very large samples face to face, through the mail,

or via the Internet, the response rate for questionnaires generally is lower than that for other forms

of self-report, particularly if the questionnaires are mailed. If the response rate is lower than 50%,

the representativeness of the sample is seriously in question. The response rate for mailed

questionnaires is usually small (25% to 40%), so researchers frequently are unable to obtain a rep-

resentative sample, even with random sampling methods. Questionnaires distributed via the Inter-

net are more convenient for subjects, which may result in a higher response rate than

questionnaires that are mailed. Many researchers are choosing the Internet format if they have

access to the potential subjects’ e-mail addresses (Grove et al., 2013; Waltz et al., 2010).

Respondents commonly fail to mark responses to all the questions, especially on long question-

naires. The incomplete nature of the data can threaten the validity of the instrument. Thus it is

important for researchers to describe how missing data were managed in their study report. With

most questionnaires, researchers analyze data at the level of individual items, rather than adding

the items together and analyzing the total scores. Responses to items are usually measured at the

nominal or ordinal level.

RESEARCH EXAMPLE—cont’d

included nonbiased questions. In summary, Dickson and colleagues (2013) implemented a reliable structured inter-

view using the CCI, a valid and unbiased index, to address the purpose of their study.

Implications for Practice Dickson et al. (2013) found that multiple comorbid conditions decreased HF patients’ self-efficacy, which reduced

the patients’ ability to provide self-care. The researchers stressed the importance of delivering self-care education

that integrated the patients’ comorbid conditions. In addition, studies are needed to develop and test interventions

that foster self-efficacy and focus on self-care for patients across multiple chronic conditions. QSEN implications are

that these evidence-based findings have the potential to improve the care and outcomes for patients with HF

(QSEN, 2013).

304 CHAPTER 10 Clarifying Measurement and Data Collection

? CRITICAL APPRAISAL GUIDELINES Questionnaires

When critically appraising a questionnaire in a published study, consider the following questions:

1. Does the questionnaire address the focus of the study outlined in the study purpose and/or objective, ques-

tions, or hypotheses? Examine the description of the contents of the questionnaire in the measurement

section of the study.

2. Does the study provide information on content-related validity for the questionnaire?

3. Was the questionnaire implemented consistently from one subject to another?

RESEARCH EXAMPLE

Questionnaires

Research Excerpt Lucas, Anderson, and Hill (2012) conducted a study to determine the knowledge of elementary school teachers

concerning the care of children with asthma. They developed a questionnaire to gather their study data, described

in the following excerpt:

“After reviewing numerous existing instruments measuring asthma knowledge, the first author determined

that there was not a single tool that adequately assessed each aspect of asthma. Therefore, a two-part ques-

tionnaire was developed for this study by the first author. Part 1 of the Basic Facts About Asthma Question-

naire (Box 10-1) was developed to assess the teacher’s knowledge of asthma.. . . The content for the

questionnaire was based on the literature. This tool is a self-administered questionnaire consisting of 25

questions, 14 true-false questions, and 11 multiple-choice questions. The questionnaire comprised 7 ques-

tions that focused on signs and symptoms, 6 questions that focused on general asthma knowledge, 5 items

that focused on treatment management, 32 questions that focused on asthma triggers, and 4 questions

regarding knowledge of medication administration. Each question was allowed one point for each correct

answer....The higher the total score, the greater the knowledge level of the participant.

Continued

BOX 10-1 BASIC FACTS ABOUT ASTHMA QUESTIONNAIRE (EXAMPLE)

Part 1

Directions: This survey is a combination of true-false and multiple-choice questions. Please circle the best

answer for each question.

1. Asthma is a disease characterized by:

a. Inflamed airways

b. Chronic airway obstruction

c. Increased mucus production within the airways

d. Hyperresponsive or sensitive airways

e. All of the above

f. None of the above

2. Which symptom(s) are indicative of a child experiencing a severe asthma attack?

a. Inability to talk in sentences or walk

b. Excessively rapid and shallow breathing

c. Restlessness

d. Preoccupation with breathing

e. All of the above

f. a, b, and d

305CHAPTER 10 Clarifying Measurement and Data Collection

Scales The scale, a form of self-report, is a more precise means of measuring phenomena than a ques-

tionnaire. Most scales are developed to measure psychosocial variables, but researchers also use

scaling techniques to obtain self-reports on physiological variables such as pain, nausea, or func-

tional capacity. The various items on most scales are summed to obtain a single score. These are

termed summated scales. Fewer random and systematic errors occur when the total score of a scale

RESEARCH EXAMPLE—cont’d

Part 2 of the questionnaire consisted of eight multiple-choice questions that queried the teachers regarding

yearsofexperience,levelofeducation,teachingspecialty,andpriortrainingonchronicillness.. . . Contentvalidity

of the evidence-based questionnaire was accomplished by an expert in the field, namely a pediatric pulmonol-

ogist, who reviewed the questionnaire assessing for adequate coverage of content focusing on general asthma

knowledge.Test-retestreliabilitywasaccomplishedbyadministering the questionnaire toagroupofelementary

teachers, not involved in this project, on two separate occasions and comparing the results. The percentage of

agreement for 25-item test and three elementary teachers was 90.7%.” (Lucas et al., 2012, p. 524)

Critical Appraisal Lucas and associates (2012) documented the need to develop a questionnaire to gather their study data. The items of

the Basic Facts About Asthma Questionnaire were based on current literature, with examples of these items provided

in the research report (see Box 10-1). The questionnaire items focused on determining elementary school teachers’

knowledge about the care of children with asthma, which addressed the purpose of the study. The researchers docu-

mented the content validity of the questionnaire that was achieved by an expert review and evidence obtained from

the literature review. The test-retest reliability of the questionnaire was also strong (90.7%), supporting this ques-

tionnaire as a reliable and valid measurement method for this study.

Implications for Practice Lucas and co-workers (2012) found that the elementary school teachers had a knowledge deficit regarding the care

of children with asthma. Teachers with exposure and/or experience with asthma scored significantly higher than

those with limited exposure. The QSEN implications are that these research findings support the need for additional

education of teachers and school personnel to assist them in providing safe, evidence-based care to children with

asthma in the classroom (QSEN, 2013).

3. Which of the following is most likely to cause an asthma attack in a child with asthma?

a. Too much medication that morning

b. Not getting enough sleep the night before

c. Extreme changes in humidity or temperature

d. Too much caffeine or sugar in their diet

e. All of the above

f. None of the above

4. What are the most common symptoms associated with asthma?

a. Coughing

b. Wheezing

c. Ear aches

d. Shortness of breath

e. All of the above

f. a, b, and d

From Lucas, T., Anderson, M. A., & Hill, P. D. (2012). What level of knowledge do elementary school teachers possess

concerning the care of children with asthma? A pilot study. Journal of Pediatric Nursing, 27(5), 524.

306 CHAPTER 10 Clarifying Measurement and Data Collection

is used (Nunnally & Bernstein, 1994). The various items in a scale increase the dimensions of the

concept that are measured by the instrument. The three types of scales described in this section that

are commonly used in nursing research are rating scales, Likert scales, and visual analog scales.

Rating Scales

Rating scales are the crudest form of measurement involving scaling techniques. A rating scale lists

an ordered series of categories of a variable that are assumed to be based on an underlying con-

tinuum. A numerical value is assigned to each category, and the fineness of the distinctions

between categories varies with the scale. Rating scales are commonly used by the general public.

In conversations, one can hear statements such as “On a scale of 1 to 10, I would rank that. . . .” Rating scales are fairly easy to develop, but researchers need to be careful to avoid end statements

that are so extreme that no subject will select them. You can use a rating scale to rate the degree of

cooperativeness of the patient or the value placed by the subject on nurse-patient interactions.

Rating scales are also used in observational measurement to guide data collection.

Some rating scales are more valid than others because they were constructed in a structured way

and used in a variety of studies with different populations. For example, the FACES Pain Scale is a

commonly used rating scale to assess the pain of children in clinical practice and has proven to be

valid and reliable over the years (Figure 10-4). Nurses often assess pain in adults with a numeric

rating scale (NRS) similar to the one in Figure 10-5. Using the NRS is more valid and reliable than

asking a patient to rate her or his pain on a scale from 1 to 10.

Likert Scale

The Likert scale is designed to determine the opinions or attitudes of study subjects. This scale con-

tains a number of declarative statements, with a scale after each statement. The Likert scale is the most

commonly used of the scaling techniques. The original version of the scale included five response

0 No hurt

1 Hurts

little bit

2 Hurts

little more

3 Hurts

even more

4 Hurts

whole lot

5 Hurts worst

FIG 10-4 Wong-Baker FACES Pain Rating Scale. Point to each face using the words to describe the pain intensity. Ask the child to choose the face that best describes the child’s own pain and record the appropriate number. (From Hockenberry, M.J., & Wilson, D. [2013]. Wong’s essentials of pediatric nursing [9th ed., p. 148]. St. Louis, MO: Mosby.)

0 1 2 3 4 5 6 7 8 9 10

Moderate Pain

Numeric Rating Scale (NRS) No

Pain Unbearable

Pain

FIG 10-5 Numeric Rating Scale.

307CHAPTER 10 Clarifying Measurement and Data Collection

categories.Eachresponsecategorywasassignedavalue,withavalueof0or1giventothemostnegative

response and a value of 4 or 5 given to the most positive response (Kerlinger & Lee, 2000; Nunnally &

Bernstein, 1994). Response choices in a Likert scale usually address agreement, evaluation, or fre-

quency.Agreementoptionsmayincludestatementssuchasstronglydisagree,disagree,uncertain,agree,

and strongly agree. Evaluation responses ask the respondent for an evaluative rating along a bad-good

dimension, such as negative to positive or terrible to excellent. Frequency responses may include

statements such as never, rarely, sometimes, frequently, and all the time. The terms used are versatile

and are selected based on the content of the questions or items in the scale. For example, an item such

as “Describe the nursing care you received during your hospitalization” could have a response scale of

unsatisfactory, below average, average, above average, and excellent.

Sometimes seven options are given on a response scale, sometimes only four. When the

response scale has an odd number of options, the middle option is usually an uncertain or neutral

category. Using a response scale with an odd number of options is controversial because it allows

the subject to avoid making a clear choice of positive or negative statements. To avoid this,

researchers may choose to provide only four or six options, with no middle point or uncertain

category. This type of scale is referred to as a forced choice version (Nunnally & Bernstein, 1994).

A Likert scale usually consists of 10 to 20 items, each addressing an element of the concept being

measured. Usually, the values obtained from each item in the instrument are summed to obtain a

single score for each subject. Although the values of each item are technically ordinal-level data, the

summed score is often analyzed as interval-level data. The CES-D is a Likert scale used to assess the

level of depression in patients in clinical practice and research (see Figure 10-3). Whittenmore and

colleagues (2009) used the CES-D in their study (see earlier). This scale has four response options—

Rarely or noneof thetime (less than 1 day)¼0, Some oralittleof thetime(1 to2 days)¼1, Occasionally ora moderate amount of time (3 to 4 days)¼2, and Mostorall of the time (5 to 7 days)¼3. Subjects are instructed on the scale: “Below is a list of the ways you might have felt or behaved. Please tell me how

often you have felt this way during the past week” (see Figure 10-3; Radloff, 1977). The scores on the

scale can range from 0 to 60, with the higher scores indicating more depressive symptoms. A score of

16 or higher has been used extensively as the cutoff point for depression. The scale has strong reli-

ability,validity,sensitivity,andspecificity(seeearlier;Locke&Putnam,2002;Sharp&Lipsky,2002).

Visual Analog Scales

The visual analog scale (VAS) is typically used to measure strength, magnitude, or intensity of

individuals’ subjective feelings, sensations, or attitudes about symptoms or situations. The VAS

is a line that is usually 100 mm long, with right angle “stops” at either end. Researchers can present

the line horizontally or vertically, with bipolar anchors or descriptors beyond either end of the line

(Waltz et al., 2010). These end anchors must include the entire range of sensations possible for the

phenomenon being measured (e.g., all and none, best and worst, no pain, and most severe pain

possible). An example of a VAS for measuring pain is presented in Figure 10-6.

Subjects are asked to place a mark through the line to indicate the intensity of the sensation or

feeling. Then researchers use a ruler to measure the distance between the left end of the line (on a

horizontal scale) and the subject’s mark. This measure is the value of the sensation. The VAS has

No pain Pain as bad as it can possibly be

FIG 10-6 Example of a visual analog scale.

308 CHAPTER 10 Clarifying Measurement and Data Collection

been used to measure pain, mood, anxiety, alertness, craving for cigarettes, quality of sleep, atti-

tudes toward environmental conditions, functional abilities, and severity of clinical symptoms.

The reliability of the VAS is usually determined by the test-retest method. The correlations

between the two administrations of the scale need to be moderate or strong to support the reli-

ability of the scale (Wewers & Lowe, 1990). Because these scales are used to measure phenomena

that are dynamic or erratic over time, test-retest reliability is sometimes not appropriate, and the

low correlation is then caused by the change in sensation versus a problem with the scale. Because

the VAS contains a single item, other methods of determining reliability such as homogeneity

cannot be used. The validity of the VAS is usually determined by correlating the VAS scores with

other measures, such as rating or Likert scales, that measure the same phenomenon, such as pain

(Waltz et al., 2010).

? CRITICAL APPRAISAL GUIDELINES Scales

When critically appraising a rating scale, Likert scale, or VAS in a study, ask the following questions:

1. Is the rating scale, Likert scale, or VAS clearly described in the research report?

2. Are the techniques used to administer and score the scale provided?

3. Is information about validity and reliability of the scale described from previous studies and for this study?

RESEARCH EXAMPLE

Scales

Research Excerpt Brenner and associates (2013) conducted a randomized controlled trial (RCT) to determine the effectiveness of a

topical anesthetic applied 15 minutes before venipuncture on children’s perception of pain and anxiety. The study

included 120 children ages 5 to 18 years who were randomly assigned to the liposomal 4% lidocaine or placebo

cream groups. The scales included in this study were critically appraised using the questions in the critical appraisal

guidelines (see earlier).

“Participant anxiety was measured by the study participant and the objective observer before (anticipatory),

during (venipuncture), and after (recovery) venipuncture using a validated visual analog (VAS) with a range of

0 to 100, with the higher scores indicating higher anxiety levels.. . . The VAS is usually a 100-mm-long scale

that measures the extremes of a patient experience or subjective phenomena. Research has shown that

lines shorter than 100 mm tend to produce greater error variance. When the VAS is used appropriately, it

is a valid, reliable, and sensitive tool for studying subjective phenomena.. . .. Pain was measured immediately

after the venipuncture by the study participant using the 6-point validated FACES pain scale, which has been

validated in patients aged 5 to 18 years, with the higher scores indicating higher pain levels. For analysis, we

used a mean FACES score.” (Brenner et al., 2013, p. 22)

Critical Appraisal Brenner and co-workers (2013) clearly identified that they used a six-point FACES scale, as shown in Figure 10-4, to

measure pain and a VAS, similar to Figure 10-5, to measure anxiety. The researchers stressed the importance of the

VAS being 100 mm long to decrease the potential for error. They also indicated that the VAS was a valid, reliable, and

sensitive tool for measuring anxiety in this study. However, the discussion of these scales would have been stronger if

specific reliability and validity information about the VAS and FACES scales had been provided from previous

research. In addition, the researchers did not conduct interrater reliability testing between raters in this study to

ensure that the VAS was consistently used in measuring the children’s anxiety. Continued

309CHAPTER 10 Clarifying Measurement and Data Collection

DATA COLLECTION PROCESS

Data collection is the process of acquiring subjects and collecting the data for a study. The actual

steps of collecting the data are specific to each study and depend on the research design and mea-

surement techniques. During the data collection process, researchers initially train the data collec-

tors, recruit study participants, implement the study intervention (if applicable), collect data in a

consistent way, and protect the integrity (or validity) of the study.

Researchers need to describe their data collection process clearly in their research report. Often,

the data collection process is addressed in the methods section of the report in a subsection entitled

“Procedure.” The strategies used to approach potential subjects who meet the sampling criteria

need to be described (see Chapter 9). Researchers should also specify the number and character-

istics of subjects who decline to participate in the study. If the study includes an intervention, the

details about the intervention and how it was implemented should be described (see Chapter 8).

The approaches used to perform measurements and the time and setting for the measurements are

also described. The desired result is a step by step description of exactly how, where, and in what

sequence the researchers collected the study data. The following sections discuss some of the com-

mon data collections tasks described in research reports, such as recruitment of study participants,

consistency of data collection, and control in implementing the study design. Nurse researchers are

also conducting studies using data from existing databases, and it is important to critically appraise

data obtained from these databases.

Recruitment of Study Participants The research report needs to describe the study participant recruitment process. Study participants

or subjects may be recruited only at the initiation of data collection or throughout the data col-

lection period. The design of the study determines the method of selecting the participants.

Recruiting the number of subjects originally planned is critical because data analysis and interpre-

tation of findings depend on having an adequate sample size.

Consistency in Data Collection The key to accurate data collection in any study is consistency. Consistency involves maintaining

the data collection pattern for each collection event as it was developed in the research plan. A good

plan will facilitate consistency and maintain the validity of the study. Researchers should note devi-

ations, even if they are minor, and report their impact on the interpretation of the findings in their

final study report. If a study uses data collectors, researchers need to report the training process and

the interrater reliability achieved during training and data collection.

RESEARCH EXAMPLE—cont’d

Implications for Practice Brenner and colleagues (2013) found no significant differences between the experimental group receiving liposomal

4% lidocaine and the group receiving the placebo cream for pain or anxiety during venipuncture. The researchers

thought that the varying ages of the children and their previous experiences with venipuncture might have affected

the study outcomes. They did confirm that anxiety negatively affected the children’s perception of pain and requires

additional research to manage both these perceptions.

310 CHAPTER 10 Clarifying Measurement and Data Collection

Control in the Study Design Researchers build controls into their study plan to minimize the influence of intervening forces on

the findings. Control is very important in quasi-experimental and experimental studies to ensure

that the intervention is consistently implemented (Shadish, Cook, & Campbell, 2002). The

research report needs to reflect the controls implemented in a study and any problems that needed

to be managed during the study. In addition to maintaining the controls identified in the plan,

researchers continually look for previously unidentified, extraneous variables that might have

an impact on the data being collected. An extraneous variable often is specific to a study and tends

to become apparent during the data collection period and needs to be discussed in the research

report. For example, Lu and associates (2013) examined the effects of acupressure on sleep quality

and controlled the environment in which the intervention was implemented to decrease the effects

of any extraneous variables, such as noise, temperature, or lighting that might influence the study

findings. The subjects did not receive sleeping medications during this study to prevent the influ-

ence of this extraneous variable. Researchers need to consider the extraneous variables identified

during data collection, data analysis, and interpretation. They should also note these variables in

the research report so that future researchers can be aware of and attempt to control them.

Studies Obtaining Data from Existing Databases Nurse researchers are increasing their use of existing databases to address the research problems

they have identified as being essential for generating evidence for practice. The reasons for using

these databases in studies are varied. With the computerization of healthcare information, more

databases have been developed internationally, nationally, regionally, at the state level, and within

clinical agencies. These databases include large amounts of information that have relevance in

developing research evidence needed for practice (Brown, 2014; Melnyk & Fineout-Overholt,

2011). The costs and technology for storage of data have improved over the last 10 years, making

these databases more reliable and accessible. Using existing databases makes it possible to conduct

complex analyses to expand our understanding of healthcare outcomes (Doran, 2011). Another

reason is that the primary collection of data in a study is limited by the availability of research

participants and expense of the data collection process. By using existing databases, researchers

are able to have larger samples, conduct more longitudinal studies, have lower costs during the

data collection process, and limit the burdens placed on the study participants (Johantgen, 2010).

Theexistinghealthcaredataconsistoftwotypes,secondaryandadministrative.Datacollectedfora

particular study are considered primary data. Data collected from previous research and stored in a

database are considered secondary data when used by other researchers to address their study pur-

poses. Because these datawere collected as part of research, details can be obtained about the data col-

lection and storage processes. In the methodology section of their research report, researchers usually

clearly indicatewhensecondarydataanalyseswereconductedaspartoftheirstudy(Johantgen,2010).

Data collected for reasons other than research are considered administrative data. Administra-

tive data are collected within clinical agencies, obtained by national, state, and local professional

organizations, and collected by federal, state, and local agencies. The processes for collection and

storage of administrative data are more complex and often more unclear than the data collection

process for research (Johantgen, 2010). The data in administrative databases are collected by dif-

ferent people in different sites using different methods. However, the data elements collected for

most administrative databases include demographics, organizational characteristics, clinical diag-

nosis and treatment, and geographic information. These database elements were standardized by

the Health Insurance Portability and Accountability Act (HIPAA) of 1996, which improved the

quality of the databases (see Chapter 4).

311CHAPTER 10 Clarifying Measurement and Data Collection

When secondary data and administrative data from existing databases are used in a study, they

need to be critically appraised to determine the quality of the study findings. The type of database

used in a study needs to be clearly described. The data in the database needs to address the

researchers’ study purpose and their objectives, questions, or hypotheses. The validity and reliabil-

ity of the data in the existing database need to be described in the research report.

? CRITICAL APPRAISAL GUIDELINES Data Collection

When critically appraising the data collection process, consider the following questions:

1. Were the recruitment and selection of study participants or subjects clearly described and appropriate?

2. Were the data collected in a consistent way?

3. Were the study controls maintained as indicated by the design? Did the design include an intervention that

was consistently implemented?

4. Was the integrity of the study protected, and how were any problems resolved?

5. Did the researchers obtain data from an existing database? If so, did the data obtained address the study

problem and objectives, questions, or hypotheses? Were the reliability and validity of the database addressed

in the research report?

RESEARCH EXAMPLE

Data Collection

Research Excerpt Whittenmore and associates (2009) developed a study to determine the effectiveness of a Diabetes Prevention Pro-

gram (DPP) delivered by NPs in primary care settings to adults who were at risk for type 2 diabetes (T2D). This

study was discussed earlier, and the measurement methods were described. The data collection process for this study

is presented in the following excerpt.

“Procedure

The NPs recruited a convenience sample of 58 adults at risk of T2D from their practices (31 treatment and 27

control group participants). The sample size for this pilot study was determined by a power analysis, recruiting

20% of what would be necessary for a clinical trial testing the intervention.

Intervention

Enhanced Standard Care

After informed consent was obtained and baseline data were collected, all participants (regardless of group

assignment) received culturally relevant written information about diabetes prevention, a 20- to 30-minute

individual session with their NP on the importance of a healthy lifestyle for the prevention of T2D, and

a 45-minute individual session with a nutritionist hired for the study.

Lifestyle Change Program

The lifestyle change program for this pilot study was based on the protocol for the DPP (Diabetes Prevention

Research Group, 1999). The goals for this program were identical to enhanced standard care, yet the

approach was more intensive and based on behavioral science evidence which recognizes the difficulty inher-

ent in diet and exercise lifestyle change.

Outcome Measures

Data were collected at the individual (participant) and organization (NP and site) levels at scheduled time

points throughout the study to evaluate the reach, implementation, and preliminary efficacy of the lifestyle

312 CHAPTER 10 Clarifying Measurement and Data Collection

K E Y C O N C E P T S

• The purpose of measurement is to produce trustworthy data or evidence that can be used in

examining the outcomes of research.

• The rules of measurement ensure that the assignment of values or categories is performed con-

sistently from one subject (or event) to another and, eventually, if the measurement strategy is

found to be meaningful, from one study to another.

• The levels of measurement from low to high are nominal, ordinal, interval, and ratio.

program. All data were collected by trained research assistants blinded to group assignment, with exception

of the GTT [glucose tolerance test]. . . . and lipids, which were collected by experienced laboratory personnel

at each site and sent to one laboratory for analysis.

Reach

Recruitment rates were documented for each NP practice. Demographic and clinical data (e.g., age, gender,

socioeconomic status, ethnicity, and health history) were collected using a standard form.

Implementation

Participant measures of implementation consisted of attendance, attrition, and a satisfaction survey. The sat-

isfaction survey was a 7-item summated scale modified from the Diabetes Treatment Satisfaction Survey to

evaluate a DPP.... Adequate internal consistency has been reported with the original scale (a ¼ .82) and was demonstrated with the modified scale in this study (a ¼ .86).

Organizational measures of implementation consisted of NP and nutrition session documentation

forms, which were created with components of each session itemized. The percentage of protocol imple-

mentation was calculated by dividing the number of protocol items by the number of items completed

per session. The NPs were also interviewed at 3 and 6 months to address issues of implementation.

Data Analysis

Data were entered into databases (Microsoft Access or Excel) via an automated Teleform (Cardiff, Vista, CA)

system. Mean substitution was employed for missing data of individual items on instruments (up to 15%). If

more than 15% of the items were missing (rare), the subscale or scale was coded as missing data.”

(Whittenmore et al., 2009, p. 4-6)

Critical Appraisal As can be seen in this study excerpt, Whittenmore and co-workers (2009) took careful steps to maintain the rigor

and control of their data collection by implementing a detailed plan. The recruit process, recruitment rates, selection

of study participants, and informed consent process were described and appropriate. The sample size was adequate

for a pilot study based on a power analysis. The researchers clearly described their implementation of the lifestyle

change program intervention to the experimental group and of standard care to both groups. The design included

scheduled pretests and post-tests, and the outcome measures were collected by trained research assistants using a

structured protocol. The percentage of protocol implemented was also calculated, ensuring the quality of the data

collection process. The reliability values of the scales used were strong but the researchers might have expanded on

the description of the scales’ validity. The physiological measures were precise and accurate. The researchers

indicated how the data were entered into the computer to promote accuracy and the actions that were taken for

consistent management of missing data. In summary, Whittenmore and colleagues (2009) provided a detailed

description of their data collection process that was extremely strong. Their highly structured data collection plan

and process of implementation decreased the potential for error and increased the likelihood that the study findings

were an accurate reflection of reality.

Implications for Practice The implications of this study’s findings for practice were discussed earlier in this chapter.

313CHAPTER 10 Clarifying Measurement and Data Collection

• Reliability in measurement is concerned with the consistency of the measurement technique;

reliability testing focuses on equivalence, stability, and homogeneity.

• The validity of an instrument is a determination of the extent to which the instrument reflects

the abstract concept being examined. Construct validity includes content-related validity and

evidence of validity from examining contrasting groups, convergence, and divergence.

• Readability level focuses on the study participants’ ability to read and comprehend the content

of an instrument, which adds to the reliability and validity of the instrument.

• Physiological measures are examined for precision, accuracy, and error in research reports.

• Diagnostic and screening tests are examined for sensitivity, specificity, and likelihood ratios.

• Common measurement approaches used in nursing research include physiological measures,

observation, interviews, questionnaires, and scales.

• The scales discussed in this chapter include rating scales, Likert scales, and visual analog scales.

• Researchers are using existing databases when conducting their studies, and the quality of these

databases need to be addressed in the research report.

• The data collection tasks that need to be critically appraised in a study include (1) recruit of

study participants, (2) consistent collection of data, and (3) maintenance of controls in the

study design.

• It is important to critically appraise the measurement methods and data collection process of

a published study for threats to validity.

REFERENCES

Als, H. (1999). Reading the premature infant. In E.

Goldson (Ed.), Nurturing the premature infant:

Developmental interventions in neonatal intensive care

nursery (pp. 18–85). New York: Oxford University

Press.

Als, H., Gilkerson, L., Duffy, F. H., McAnulty, G. B.,

Buehler, D. M., Vandenberg, K., et al. (2003). A three-

center, randomized, controlled trial of individualized

developmental care for very low birth weight preterm

infants: Medical neurodevelopmental, parenting and

caregiving effects. Journal of Developmental and

Behavioral Pediatrics, 24(6), 399–408.

Becker, P. T., Grunwald, P. C., & Brazy, J. E. (1999). Motor

organization in very low birth weight infants during

caregiving: Effects of a developmental intervention.

Journal of Developmental and Behavioral Pediatrics, 20

(5), 344–354.

Bialocerkowski, A., Klupp, N., & Bragge, P. (2010).

Research methodology series: How to read

and critically appraise a reliability article.

International Journal of Therapy and Rehabilitation, 17

(3), 114–120.

Brenner, S. M., Rupp, V., Boucher, J., Weaver, K., Dusza, S.

W., & Bokovoy, J. (2013). A randomized, controlled

trial to evaluate topical anesthetic for 15 minutes before

venipuncture in pediatrics. American Journal of

Emergency Medicine, 31(1), 20–25.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Buysse, D. L., Reynolds, C. F., 3rd., Monk, T. H., Berman, S.

R., & Kupfer, D. J. (1989). The Pittsburgh Sleep Quality

Index: A new instrument for psychiatric practice and

research. Psychiatry Research, 28(2), 193–213.

Campo, M., Shiyko, M. P., & Lichtman, S. W. (2010).

Sensitivity and specificity: A review of related statistics

and controversies in the context of physical therapist

education. Journal of Physical Therapy Education,

24(3), 69–78.

Charlson, M. E., Pompei, P., Ales, K. L., & MacKenzie, C.

R. (1987). A new method of classifying prognostic

comorbidity in longitudinal studies: Development and

validation. Journal of Chronic Diseases, 40(5), 373–383.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh: Churchill

Livingstone Elsevier.

Creswell, J. W. (2014). Research design: Qualitative,

quantitative and mixed methods approaches (4th ed.).

Thousand Oaks, CA: Sage.

DeVon, H. A., Block, M. E., Moyle-Wright, P., Ernst, D. M.,

Hayden, S. J., Lazzara, D. J., et al. (2007). A

psychometric toolbox for testing validity and

reliability. Journal of Nursing Scholarship, 39(2),

155–164.

314 CHAPTER 10 Clarifying Measurement and Data Collection

Diabetes Prevention Research Group. (1999). Design and

methods for a clinical trial in the prevention of type 2

diabetes. Diabetes Care, 22(4), 623–634.

Dickson, V. V., Buck, H., & Riegel, B. (2013). Multiple

comorbid conditions challenge heart failure self-care by

decreasing self-efficacy. Nursing Research, 62(1), 2–9.

Doran, D. M. (2011). Nursing outcomes: The state of the

science (2nd ed.). Sudbury, MA: Jones & Bartlett.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia: F. A.

Davis.

Gift,A.G.,&Soeken,K.L.(1988).Assessmentofphysiologic

instruments. Heart & Lung, 17(2), 128–133.

Grove, S. K. (2007). Statistics for health care research: A

practical workbook. Philadelphia: Elsevier Saunders.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis: Elsevier Saunders.

Jefferson, V. W., Melkus, G. D., & Spollett, G. R. (2000).

Health promotion practices of young black women at

risk for diabetes. Diabetes Educator, 26(2), 295–302.

Johantgen, M. (2010). Using existing administrative and

national databases. In C. F. Waltz, O. L. Strickland, & E.

R. Lenz (Eds.), Measurement in nursing and health

research (pp. 241–250) (4th ed.). New York: Springer.

Kaplan, A. (1963). The conduct of inquiry: Methodology for

behavioral science. New York: Harper & Row.

Kerlinger,F.N.,&Lee,H.B.(2000).Foundationsofbehavioral

research (4th ed.). Fort Worth, TX: Harcourt.

Klein, S., Allison, D. B., Heymsfield, S. B., Kelley, D. E.,

Leibel, R. L., Nonas, C., et al. (2007). Waist

circumference and cardiometabolic risk: A consensus

statement from Shaping America’s Health: Association

for Weight Management and Obesity Prevention;

NAASO, The Obesity Society; the American Society for

Nutrition and the American Diabetes Association.

Obesity, 15(5), 1061–1067.

Liaw, J., Yang, L., Chang, L., Chou, H., & Chao, S. (2009).

Improving neonatal caregiving through a

developmentally supportive care training program.

Applied Nursing Research, 22(2), 86–93.

Locke, B. Z., & Putnam, P. (2002). Center for Epidemiologic

Studies Depression Scale (CES-D Scale). Bethesda, MD:

National Institute of Mental Health.

Lu, M., Lin, S., Chen, K., Tsang, H., & Su, S. (2013).

Acupressure improves sleep quality of psychogeriatric

inpatients. Nursing Research, 62(2), 130–137.

Lucas, T., Anderson, M. A., & Hill, P. D. (2012). What level

of knowledge do elementary school teachers possess

concerning the care of children with asthma? A pilot

study. Journal of Pediatric Nursing, 27(5), 523–527.

Marshall, C., & Rossman, G. B. (2011). Designing

qualitative research (5th ed.). Thousand Oaks, CA:

Sage.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-

based practice in nursing & healthcare: A guide to best

practice (2nd ed.). Philadelphia: Lippincott, Williams,

& Wilkins.

Munhall, P. L. (2012). Nursing research: A qualitative

perspective (5th ed.). Sudbury, MA: Jones & Bartlett.

Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric

theory (3rd ed.). New York: McGraw-Hill.

Peters, K. (1998). Bathing premature infants: Physiological

and behavioral consequences. American Journal of

Critical Care, 7(2), 90–100.

Posner, S. F., Stewart, A. L., Marin, G., & Perez-Stable, E. J.

(2001). Factor variability of the Center for

Epidemiological Studies Depression Scale (CES-D)

among urban Latinos. Ethnicity & Health, 6(2),

137–144.

Pugh, L. C., & DeKeyser, F. G. (1995). Use of physiologic

variables in nursing research. Image—Journal of

Nursing Scholarship, 27(4), 273–276.

Quality and Safety Education for Nurses (QSEN). (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved July 5, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas.

Radloff, L. S. (1977). The CES-D scale: A self report

depression scale for research in the general population.

Applied Psychological Measurement, 1, 385–394.

Rew, L., Stuppy, D., & Becker, H. (1988). Construct

validity in instrument development: A vital link

between nursing practice, research, and theory.

Advances in Nursing Science, 10(4), 10–22.

Ryan-Wenger, N. A. (2010). Evaluation of measurement

precision, accuracy, and error in biophysical data for

clinical research and practice. In C. F. Waltz, O. L.

Strickland, & E. R. Lenz (Eds.), Measurement in nursing

and health research (pp. 371–383) (4th ed.). New York:

Springer.

Sackett, D. L., Straus, S. E., Richardson, W. S.,

Rosenberg, W., & Haynes, R. B. (2000). Evidence-based

medicine: How to practice and teach EBM (2nd ed.).

London: Churchill Livingstone.

Sarikaya, S., Aktas, C., Ay, D., Cetin, A., & Celikmen, F.

(2010). Sensitivity and specificity of rapid antigen

detection testing for diagnosing pharyngitis in

emergency department. Ear, Nose, & Throat Journal, 89

(4), 180–182.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002).

Experimental and quasi-experimental designs for

generalized causal inference. Chicago: Rand McNally.

315CHAPTER 10 Clarifying Measurement and Data Collection

Sharp, L. K., & Lipsky, M. S. (2002). Screening for

depression across the lifespan: A review of measures for

use in primacy care settings. American Family

Physician, 66(6), 1001–1008.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Stevens, S. S. (1946). On the theory of scales of

measurement. Science, 103(2684), 677–680.

Stone, K. S., & Frazier, S. K. (2010). Measurement of

physiological variables using biomedical

instrumentation. In C. F. Waltz, O. L. Strickland, & E.

R. Lenz (Eds.), Measurement in nursing and

health research (pp. 335–370) (4th ed.). New York:

Springer.

Walker, S. N., Sechrist, K. R., & Pender, N. J. (1987). The

Health-Promoting Lifestyle Profile: Development and

psychometric characteristics. Nursing Research, 36(2),

76–81.

Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010).

Measurement in nursing and health research (4th ed.).

New York: Springer Publishing Company.

Wewers, M. E., & Lowe, N. K. (1990). A critical review of

visual analogue scales in the measurement of clinical

phenomena. Research in Nursing & Health, 13(4),

227–236.

Whittenmore, R., Melkus, G., Wagner, J., Dziura, J.,

Northrup, V., & Grey, M. (2009). Translating the

diabetes prevention program to primary care: A pilot

study. Nursing Research, 58(1), 2–12.

316 CHAPTER 10 Clarifying Measurement and Data Collection

C H A P T E R

11 Understanding Statistics in Research

C H A P T E R OV E R V I E W

Understanding the Elements of the Statistical

Analysis Process, 319

Management of Missing Data, 320

Description of the Sample, 320

Reliability of Measurement Methods, 323

Exploratory Analyses, 323

Inferential Statistical Analyses, 323

Understanding Theories and

Concepts of the Statistical Analysis

Process, 324

Probability Theory, 324

Decision Theory, Hypothesis Testing, and Level

of Significance, 325

Inference and Generalization, 326

Normal Curve, 326

Tailedness, 327

Type I and Type II Errors, 328

Power: Controlling the Risk of a Type II

Error, 329

Degrees of Freedom, 329

Using Statistics to Describe, 330

Frequency Distributions, 330

Measures of Central Tendency, 331

Measures of Dispersion, 333

Understanding Descriptive Statistical

Results, 336

Determining the Appropriateness of Inferential

Statistics in Studies, 337

Critical Appraisal Guidelines for Inferential

Statistical Analyses, 338

Using Statistics to Examine Relationships, 340

Pearson Product-Moment Correlation, 340

Factor Analysis, 343

Using Statistics to Predict Outcomes, 344

Regression Analysis, 344

Using Statistics to Examine Differences, 347

Chi-Square Test of Independence, 347

t-Test, 349

Analysis of Variance (ANOVA), 351

Analysis of Covariance (ANCOVA), 353

Interpreting Research Outcomes, 353

Types of Results, 353

Findings, 354

Exploring the Significance of Findings, 354

Clinical Importance of Findings, 355

Limitations, 355

Conclusions, 355

Generalizing the Findings, 356

Implications for Nursing, 356

Recommendations for Further Studies, 356

Key Concepts, 358

References, 359

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Identify the purposes of statistical analyses.

2. Describe the process of data analysis: (a)

management of missing data; (b) description of

the sample; (c) reliability of the measurement

methods; (d) exploratory analysis of the data;

and (e) use of inferential statistical analyses

317

guided by study objectives, questions, or

hypotheses.

3. Describe probability theory and decision theory

that guide statistical data analysis.

4. Describe the process of inferring from a sample

to a population.

5. Discuss the distribution of the normal curve.

6. Compare and contrast type I and type II errors.

7. Identify descriptive analyses, such as frequency

distributions, percentages, measures of central

tendency, and measures of dispersion,

conducted to describe the samples and study

variables in research.

8. Describe the results obtained from the

inferential statistical analyses conducted to

examine relationships (Pearson product-

moment correlation and factor analysis) and

make predictions (linear and multiple

regression analysis).

9. Describe the results obtained from inferential

statistical analyses conducted to examine

differences, such as chi-square analysis, t-test,

analysis of variance, and analysis of

covariance.

10. Describe the five types of results obtained

from quasi-experimental and experimental

studies that are interpreted within a decision

theory framework: (a) significant and

predicted results; (b) nonsignificant results;

(c) significant and unpredicted results;

(d) mixed results; and (e) unexpected

results.

11. Compare and contrast statistical significance

and clinical importance of results.

12. Critically appraise statistical results, findings,

limitations, conclusions, generalization of

findings, nursing implications, and suggestions

for further research in a study.

K E Y T E R M S

Analysis of covariance,

p. 353

Analysis of variance, p. 351

Between-group variance, p. 351

Bimodal distribution, p. 333

Bivariate correlation, p. 340

Causality, p. 347

Chi-square test of

independence, p. 347

Clinical importance, p. 355

Coefficient of multiple

determination, p. 345

Conclusions, p. 355

Confidence interval, p. 334

Decision theory, p. 325

Degrees of freedom, p. 329

Descriptive statistics, p. 319

Effect size, p. 329

Explained variance, p. 341

Exploratory analysis, p. 323

Factor, p. 343

Factor analysis, p. 343

Findings, p. 354

Frequency distribution, p. 330

Generalization, p. 326

Grouped frequency

distributions, p. 330

Implications for nursing, p. 356

Independent groups, p. 338

Inference, p. 326

Inferential statistics, p. 319

Level of statistical significance,

p. 325

Limitations, p. 355

Line of best fit, p. 344

Mean, p. 333

Measures of central tendency,

p. 331

Measures of dispersion, p. 333

Median, p. 333

Mixed results, p. 354

Mode, p. 331

Multiple regression, p. 344

Negative relationship, p. 341

Nonparametric analyses, p. 338

Nonsignificant results, p. 353

Normal curve, p. 326

One-tailed test of significance,

p. 327

Outliers, p. 323

Paired groups or dependent

groups, p. 338

Parametric analyses, p. 338

Pearson product-moment

correlation, p. 340

Percentage distribution, p. 331

Positive relationship, p. 341

Posthoc analyses, p. 347

Power, p. 329

Power analysis, p. 329

Probability theory, p. 324

Range, p. 333

Recommendations for further

study, p. 356

Regression analysis, p. 344

Scatterplot, p. 335

Significant and unpredicted

results, p. 354

Significant results, p. 353

Simple linear regression, p. 344

Standard deviation, p. 334

Standardized scores, p. 335

Statistical techniques, p. 319

Symmetrical, p. 341

Total variance, p. 351

318 CHAPTER 11 Understanding Statistics in Research

t-Test, p. 349

Two-tailed test of significance,

p. 327

Type I error, p. 328

Type II error, p. 329

Unexpected results, p. 354

Unexplained variance, p. 341

Ungrouped frequency

distribution, p. 330

Variance, p. 334

Within-group variance,

p. 351

x-axis, p. 335

y-axis, p. 335

Z-score, p. 335

The expectation that nursing practice be based on research evidence has made it important for

students and clinical nurses to acquire skills in reading and evaluating the results from statistical

analyses (Brown, 2014; Craig & Smyth, 2012). Nurses probably have more anxiety about data anal-

ysis and statistical results than they do about any other aspect of the research process. We hope that

this chapter will dispel some of that anxiety and facilitate your critical appraisal of research reports.

The statistical information in this chapter is provided from the perspective of reading, understand-

ing, and critically appraising the results sections in quantitative studies rather than on selecting

statistical procedures for data analysis or performing statistical analyses.

To appraise the results from quantitative or outcomes studies critically, you need to be able to

(1) identify the statistical procedures used, (2) judge whether these procedures were appropriate for

the purpose and the hypotheses, questions, or objectives of the study and level of measurement of

the variables, (3) determine whether the researchers’ interpretations of the results are appropriate,

and (4) evaluate the clinical importance of the study’s findings. This chapter was developed to

provide you with a background for critically appraising the results and discussion sections of quan-

titative studies.

The elements of the statistical analysis process are discussed at the beginning of this chapter.

Relevant theories and concepts of statistical analyses are described to provide a background for

understanding the results included in research reports. Some of the common statistical procedures

used to describe variables, examine relationships among variables, predict outcomes, and test

causal hypotheses are introduced. Strategies are identified for determining the appropriateness

of the statistical analysis techniques included in the results sections of published studies. Guide-

lines are provided for critically appraising the statistical results of studies. The chapter concludes

with guidelines for critically appraising the following study outcomes—findings, limitations, con-

clusions, generalizations, implications for nursing practice, and suggestions for further study.

Examples from current studies are provided throughout this chapter to promote your understand-

ing of the content.

UNDERSTANDING THE ELEMENTS OF THE STATISTICAL ANALYSIS PROCESS

Statistical techniques are analysis procedures used to examine, reduce, and give meaning to the

numerical data gathered in a study. In this textbook, statistics are divided into two major catego-

ries, descriptive and inferential. Descriptive statistics are summary statistics that allow the

researcher to organize data in ways that give meaning and facilitate insight. Descriptive statistics

are calculated to describe the sample and key study variables. Inferential statistics are designed to

address objectives, questions, and hypotheses in studies to allow inference from the study sample

to the target population. Inferential analyses are conducted to identify relationships, examine pre-

dictions, and determine group differences in studies.

In critically appraising a study, it may be helpful to understand the process that researchers use

to perform data analyses. The statistical analysis process consists of several stages: (1) management

319CHAPTER 11 Understanding Statistics in Research

of missing data; (2) description of the sample; (3) examination of the reliability of measurement

methods; (4) conduct of exploratory analyses of study data; and (5) conduct of inferential analyses

guided by the study hypotheses, questions, or objectives. Although not all of these stages are

equally reflected in the final published report of the study, they all contribute to the insights that

can be gained from analysis of the study data.

Management of Missing Data Except in very small studies, researchers almost always use computers for data analyses. The first

step of the process is entering the data into the computer using a systematic plan designed to

reduce errors. Missing data points are identified during data entry. If enough data are missing

for certain variables, researchers may have to determine whether the data are sufficient to perform

analyses using those variables. In some cases, subjects must be excluded from an analysis because

data considered essential to that analysis are missing. In examining the results of a published study,

you might note that the number of subjects included in the final analyses is less than the original

sample; this could be a result of attrition and/or subjects with missing data being excluded from the

analyses. It is important for researchers to discuss missing data and its management in the study.

Description of the Sample Researchers obtain as complete a picture of the sample as possible for their research report. Vari-

ables relevant to the sample are called demographic variables and might include age, gender, eth-

nicity, educational level, and number of chronic illnesses (see Chapter 5). Demographic variables

measured at the nominal and ordinal levels, such as gender, ethnicity, and educational level, are

analyzed with frequencies and percentages. Estimates of central tendency (e.g., the mean) and dis-

persion (e.g., the standard deviation) are calculated for variables such as age and number of

chronic illnesses that are measured at the ratio level. Analysis of these demographic variables pro-

duces the sample characteristics for the study participants or subjects. When a study includes more

than one group (e.g., treatment group and control or comparison group), researchers often com-

pare the groups in relation to the demographic variables. For example, it might be important to

know whether the groups’ distributions of age and chronic illnesses were similar. When demo-

graphic variables are similar for the treatment (intervention) and comparison groups, the study

is stronger because the outcomes are more likely to be caused by the intervention rather than

by group differences at the start of the study.

? CRITICAL APPRAISAL GUIDELINES Description of the Sample

When critically appraising a study, you need to examine the sample characteristics and judge the representa-

tiveness of the sample using the following questions.

1. What variables were used to describe the sample?

2. What statistical techniques were used to descriptively analyze the demographic variables, and were these

techniques appropriate based on the level of measurement of these variables? Figure 10-2 covers the rules

for the nominal, ordinal, interval, and ratio levels of measurement.

3. Was the sample representative of the study target population? For example, was this study’s sample similar

to the samples of other studies in this area that were cited in the literature review or the discussion section of

the study?

4. If the sample is divided into groups for data analyses, was the similarity or homogeneity of the groups dis-

cussed? (See Chapter 9.)

320 CHAPTER 11 Understanding Statistics in Research

RESEARCH EXAMPLE

Description of the Sample

Research Study Kim, Chung, Park, and Kang (2012) conducted a quasi-experimental study to examine the effectiveness of an aqua-

robic exercise program on the self-efficacy, pain, body weight, blood lipid levels, and depression of patients with

osteoarthritis. The study included 70 subjects, with 35 patients randomly assigned to the experimental

group and 35 to the control group. We recommend that you obtain this article, and review this study. The

results from this study are presented as examples several times in this chapter to facilitate your understanding

of statistical techniques.

The demographic variables used to describe the sample in the Kim and colleagues’ (2012) study included age,

educational level, marital status, religion, occupation, income, and health status. Descriptive statistics of frequency

and percentage (%) were used to analyze the demographic data, and the experimental and control groups were

compared for similarities. The results from these analyses are presented in Table 11-1

Continued

TABLE 11-1 Homogeneity Test of General Characteristics Between Experimental and Control Groups

Characteristics

Experimental Group n ¼ 35 n %ð Þ

Control Group n ¼ 35 n %ð Þ p

Age (yr)

55-59 0 (0.0) 2 (5.7) 0.545*

60-64 11 (31.4) 9 (25.7)

65-69 15 (42.9) 17 (48.6)

�70 9 (25.7) 7 (20.0) Educational Level

None 4 (11.4) 1 (2.9) 0.373*

Elementary 5 (14.3) 11 (31.4)

Middle school 15 (42.9) 14 (40.0)

High school 5 (14.3) 5 (14.3)

College or more 6 (17.1) 4 (11.4)

Marital Status

Married 22 (62.9) 22 (62.9) 1.000*

Bereavement 11 (31.4) 12 (34.3)

Other 2 (5.7) 1 (2.9)

Religion

Christian 8 (22.9) 7 (20.0) 0.907*

Catholic 12 (34.3) 15 (42.9)

Buddhist 9 (25.7) 9 (25.7)

None 5 (14.3) 4 (11.4)

Occupation

Yes 4 (11.4) 3 (8.6) 1.000*

None 31 (88.6) 32 (91.4)

321CHAPTER 11 Understanding Statistics in Research

RESEARCH EXAMPLE—cont’d

Critical Appraisal Kim and associates (2012) developed a table that clearly presented the results of their analysis of demographic vari-

ables, and they discussed this table in the results section of their research report. The demographic variables of age,

educational level, marital status, occupation, and income are commonly used in many studies to describe the sam-

ples. The descriptive analysis techniques of frequency and percentage were appropriate for the demographic vari-

ables measured at the nominal or ordinal level. Age, educational level, income, and health status were measured at

the ordinal level, and marital status, religion, and occupation were measured at the nominal level.

The study included two groups (experimental and control), and differences between these two groups were exam-

ined for each of the demographic variables using the chi-square or Fisher’s exact tests. These analytical procedures

are appropriate for examining group differences for nominal-level variables and are discussed in more depth later in

this chapter. The p values (probabilities in this study) were all greater than 0.05, indicating no significant differences

between the experimental and control groups for the demographic variables. Therefore the groups could be con-

sidered demographically similar in this study, so any significant differences noted are more likely to be caused by the

study intervention than by differences in the groups at the start of the study.

Implications for Practice Kim and co-workers (2012) implemented a structured aquarobic exercise program that included two educational

sessions, followed by selected aerobic exercises. The aquarobic exercises are detailed in a table in the article and

involved an instructor leading the patients with osteoarthritis through various aerobic exercises in the water for

1 hour, three times a week, for a total of 36 sessions over 12 weeks. The researchers found that the “Aquarobic Exer-

cise Program was effective in enhancing self-efficacy, decreasing pain, and improving depression levels, body weight,

and blood lipid levels in patients with osteoarthritis” (Kim et al., 2012, p. 181). They recommended the use of this

program in managing patients with osteoarthritis but also recognized the need for additional research to determine

the long-term benefits of this program for these patients. The Quality and Safety Education for Nursing Institute

(QSEN, 2013) provides competencies for prelicensure nurses. The QSEN implication of this research report is the

evidence-based intervention of an aquarobic exercise program, which improved the health outcomes for these

patients with osteoarthritis. Nurses and students are encouraged to use research findings in promoting an

evidence-based practice (EBP) for nursing.

TABLE 11-1 Homogeneity Test of General Characteristics Between Experimental and Control Groups—cont’d

Characteristics

Experimental Group n ¼ 35 n %ð Þ

Control Group n ¼ 35 n %ð Þ p

Income (per/mo)

<100 18 (51.4) 18 (51.4) 0.496*

100-200 5 (14.3) 9 (25.7)

201-300 7 (20.0) 6 (17.1)

>300 5 (14.3) 2 (5.7)

Health Status

Good 5 (14.7) 5 (14.3) 0.649

Fair 16 (47.1) 16 (45.7)

Bad 13 (38.2) 14 (40.0)

*Fisher’s exact test.

From Kim, I., Chung, S., Park, Y., & Kang, H. (2012). The effectiveness of an aquarobic exercise program for

patients with osteoarthritis. Applied Nursing Research, 25(3), p. 186 (Table 2 from the article).

322 CHAPTER 11 Understanding Statistics in Research

Reliability of Measurement Methods Researchers need to report the reliability of the measurement methods used in their study. The

reliability of observational or physiological measures is usually determined during the data collec-

tion phase and needs to be noted in the research report. If a scale was used to collect data, the

Cronbach alpha procedure needs to be applied to the scale items to determine the reliability of

the scale for this study (Waltz, Strickland, & Lenz, 2010). If the Cronbach alpha coefficient is unac-

ceptably low (<0.70), the researcher must decide whether to analyze the data collected with the instrument. Avalue of 0.70 is considered acceptable, especially for newly developed scales. A Cron-

bach alpha coefficient value of 0.80 to 0.89 from previous research indicates that a scale is suffi-

ciently reliable to use in a study (see Chapter 10). The t-test or Pearson’s correlation statistics may

be used to determine test-retest reliability (Grove, Burns, & Gray, 2013). In critically appraising a

study, you need to examine the reliability of the measurement methods and the statistical proce-

dures used to determine these values. Sometimes researchers examine the validity of the measure-

ment methods used in their studies, and this content also needs to be included in the research

report (see Chapter 10).

An example is presented from the Kim and colleagues’ (2012) study (see earlier). They mea-

sured self-efficacy with a 14-item Likert-type scale that had been previously developed for patients

with arthritis. The higher scores indicated greater levels of self-efficacy. The calculated Cronbach

alpha for this scale in this study was 0.90, indicating 90% reliability or consistency in the measure-

ment of self-efficacy and 10% error. Kim and associates (2012) measured depression with the Zung

Self-Rating Depression Scale, which “consisted of 20 items (10 positive and 10 negative) on a

4-point Likert-type scale. Negative responses were converted into scores, and higher scores indi-

cated greater levels of depression. Cronbach’s alpha in this study was 0.75” (75% reliability and

25% error; Kim et al., 2012, p. 185). This study included a concise description of the scales used

to collect psychosocial data and documented the scales’ reliability using Cronbach alpha values.

The reliability of the self-efficacy scale was strong at 0.90, but the Zung Self-Rating Depression

Scale reliability (0.75) was a little low for an established scale.

Exploratory Analyses The next step, exploratory analysis, is used to examine all the data descriptively. This step is dis-

cussed in more detail later (see later, “Using Statistics to Describe”). Data on each study variable are

examined using measures of central tendency and dispersion to determine the nature of variation

in the data and identify outliers. Outliers are subjects or data points with extreme values (values

that lie far from other plotted points on a graph) that seem unlike the rest of the sample.

Researchers usually indicate whether outliers are identified during data analysis and how these

were managed. In critically appraising a study’s results, note any discussion of outliers and deter-

mine how they were managed and might have affected the study results.

Inferential Statistical Analyses The final phase of data analysis involves conducting inferential statistical analyses for the purpose

of generalizing findings from the study sample to appropriate accessible and target populations. To

justify generalization of the results from inferential statistical analyses, a rigorous research meth-

odology is needed, including a strong research design (Shadish, Cook, Campbell, 2002), reliable

and valid measurement methods (Waltz et al., 2010), and a large sample size (Cohen, 1988).

Most researchers include a section in their research report that identifies the statistical analysis

techniques conducted on the study data and the program used to calculate them. This discussion

323CHAPTER 11 Understanding Statistics in Research

includes the inferential analysis techniques (e.g., those focused on relationships, prediction, and

differences) and sometimes the descriptive analysis techniques (e.g., frequencies, percentages, and

measures of central tendency and dispersion) conducted in the study. The identification of data

analysis techniques conducted in a study are usually presented just prior to the study’s results sec-

tion. Kim and co-workers (2012) had a strong pretest and post-test quasi-experimental design with

experimental and control groups (see Chapter 8). The study variables were measured with fairly

reliable scales and accurate and precise physiological instruments. The inferential statistical ana-

lyses conducted were clearly identified and focused on addressing the study purpose. This study

excerpt identifies the analysis techniques:

“Data Analysis Data analysis was performed using SPSS [Statistical Package for the Social Sciences] version 12.0.

Homogeneity of the two groups was assessed using Fisher’s exact test, the chi-square test, and indepen-

dent t-tests [discussed later in this chapter]. Comparisons of posttest values for the experimental and

control groups were then made using independent t-tests.” (Kim et al., 2012, p. 185)

UNDERSTANDING THEORIES AND CONCEPTS OF THE STATISTICAL ANALYSIS PROCESS

One reason that nurses tend to avoid statistics is that many were taught only the mathematical

procedures of calculating statistical equations, with little or no explanation of the logic behind

those procedures or the meaning of the results. Computation is a mechanical process usually per-

formed by a computer, and information about the calculation procedure is not necessary to begin

understanding statistical results. Here we present an approach to data analysis that will enhance

your understanding of the statistical analysis process. You can then use this understanding to

appraise data analysis techniques critically in the results section of research reports.

This section presents a brief explanation of some of the theories and concepts important in under-

standing the statistical analysis process. Probability theory and decision theory are discussed, and

the concepts of hypothesis testing, level of significance, inference, generalization, the normal curve,

tailedness, type I and type II errors, power, and degrees of freedom are described. More extensive

discussion of these topics can be found in other sources, and we recommend our own textbooks

(Grove, 2007; Grove et al., 2013) and a quality statistical text by Plichta and Kelvin (2013).

Probability Theory Probability theory is used to explain the extent of a relationship, the probability that an event will

occur in a given situation, or the probability that an event can be accurately predicted. The

researcher might want to know the probability that a particular outcome will result from a nursing

intervention. For example, the researcher may want to know how likely it is that urinary catheter-

ization during hospitalization will lead to a urinary tract infection (UTI) after discharge from the

hospital. The researcher also may want to know the probability that subjects in the experimental

group are members of the same larger population from which the comparison or control group

subjects were taken. Probability is expressed as a lower case letter p, with values expressed as per-

centages or as a decimal value, ranging from 0 to 1. For example, if the probability is 0.23, then it

is expressed as p¼0.23. This means that there is a 23% probability that a particular outcome (e.g., a UTI) will occur. Probability values also can be stated as less than a specific value, such

as 0.05, expressed as p<0.05. (The symbol<means less than.) A study may indicate the

324 CHAPTER 11 Understanding Statistics in Research

probability that the experimental group subjects were members of the same larger population as

the comparison group subjects was less than or equal to 5% (p�0.05). In other words, it is not very likely that the comparison group and the experimental group are from the same population. Put

another way, you might say that there is a 5% chance that the two groups are from the same pop-

ulation, and a 95% chance that they are not from the same population. The inference is that the

experimental group is different from the comparison group because of the effect of the interven-

tion in the study. Probability values often are stated with the results of inferential statistical ana-

lyses. In critically appraising studies, it is useful to recognize these symbols and understand what

they mean.

Decision Theory, Hypothesis Testing, and Level of Significance Decision theory assumes that all of the groups in a study (e.g., experimental and comparison

groups) used to test a particular hypothesis are components of the same population relative to

the variables under study. This expectation (or assumption) traditionally is expressed as a null

hypothesis, which states that there is no difference between (or among) the groups in a study,

in terms of the variables included in the hypothesis (see Chapter 5 for more details of types of

hypotheses). It is up to the researcher to provide evidence for a genuine difference between the

groups. For example, the researcher may hypothesize that the frequency of UTIs that occurred after

discharge from the hospital in patients who were catheterized during hospitalization is no different

from the frequency of such infections in those who were not catheterized. To test the assumption of

no difference, a cutoff point is selected before data collection. The cutoff point, referred to as alpha

(a), or the level of statistical significance, is the probability level at which the results of statistical analysis are judged to indicate a statistically significant difference between the groups. The level of

significance selected for most nursing studies is 0.05. If the p value found in the statistical analysis is

less than or equal to 0.05, the experimental and comparison groups are considered to be signif-

icantly different (members of different populations).

Decision theory requires that the cutoff point selected for a study be absolute. Absolute means

that even if the value obtained is only a fraction above the cutoff point, the samples are considered

to be from the same population, and no meaning can be attributed to the differences. It is inap-

propriate when using decision theory to state that the findings approached significance at

p¼0.051 if the alpha level was set at 0.05. Using decision theory rules, this finding indicates that the groups tested are not significantly different, and the null hypothesis is accepted. On the other

hand, once the level of significance has been set at 0.05 by the researcher, if the analysis reveals a

significant difference of 0.001, this result is not considered more significant than the 0.05 originally

proposed (Slakter, Wu, & Suzaki-Slakter, 1991). The level of significance is dichotomous, which

means that the difference is significant or not significant; there are no “degrees” of significance.

However, some people, not realizing that their reasoning has shifted from decision theory to prob-

ability theory, indicate in their research report that the 0.001 result makes the findings more sig-

nificant than if they had obtained only a 0.05 level of significance.

From the perspective of probability theory, there is considerable difference in the risk of occur-

rence of a type I error (saying something is significant when it is not) when the probability is

between 0.05 and 0.001. If p¼0.001, the probability that the two groups are components of the same population is 1 in 1000; if p¼0.05, the probability that the groups belong to the same population is 5 in 100. In other words, if p¼0.05, then in 5 times out of 100, groups with statistical values such as those found in these statistical analyses actually are members of the same popula-

tion, and the conclusion that the groups are different is erroneous.

325CHAPTER 11 Understanding Statistics in Research

In computer analysis, the probability value obtained from each data analysis (e.g., p¼0.03 or p¼0.07) frequently is provided on the printout and is often reported by the researcher in the pub- lished study, along with the level of significance set before data analysis was conducted. In sum-

mary, the probability (p) value reveals the risk of a type I error in a particular study. The alpha (a) value, set prior to the study, usually at a¼0.05, reveals whether the probability value for a partic- ular analysis in a study met the cutoff point for a significant difference between groups or a sig-

nificant relationship between variables.

Inference and Generalization An inference is a conclusion or judgment based on evidence. Statistical inferences are made cau-

tiously and with great care. The decision theory rules used to interpret the results of statistical pro-

cedures increase the probability that inferences are accurate. A generalization is the application of

information that has been acquired from a specific instance to a general situation. Generalizing

requires making an inference; both require the use of inductive reasoning. An inference is made

from a specific case and extended to a general truth, from a part to the whole, from the concrete to

the abstract, and from the known to the unknown. In research, an inference is made from the study

findings obtained from a specific sample and applied to a more general target population, using the

results from statistical analyses. For example, a researcher may conclude in a research report that a

significant difference was found in the number of UTIs between two samples, one in which the

subjects had been catheterized during hospitalization and another in which the subjects had

not. The researcher also may conclude that this difference can be expected in all patients who have

received care in hospitals. The findings are generalized from the sample in the study to all previ-

ously hospitalized patients. Statisticians and researchers can never prove something using infer-

ence; they can never be certain that their inferences and generalizations are correct. The

researcher’s generalization of the incidence of UTIs may not have been carefully thought out—

the findings may have been generalized to a population that was overly broad. It is possible that

in the more general population, there is no difference in the incidence of UTIs based on whether

the patient was catheterized or not. Generalizing study findings are part of the discussion section of

a research report (see later).

Normal Curve A normal curve is a theoretical frequency distribution of all possible values in a population; how-

ever, no real distribution exactly fits the normal curve (Figure 11-1). The idea of the normal curve

was developed by an 18-year-old mathematician, Johann Gauss, in 1795. He found that data from

variables (e.g., the mean of each sample) measured repeatedly in many samples from the same

population can be combined into one large sample. From this large sample, a more accurate rep-

resentation can be developed of the pattern of the curve in that population than is possible with

only one sample. Surprisingly, in most cases, the curve is similar, regardless of the specific variables

examined or the population studied.

Levels of significance and probability are based on the logic of the normal curve. The normal

curve presented in Figure 11-1 shows the distribution of values for a single population. Note that

95.5% of the values are within 2 standard deviations (SDs) of the mean, ranging from �2 to +2 SDs. (Standard deviation is described later in this chapter; see “Using Statistics to Describe.”) Thus

there is approximately a 95% probability that a given measured value (e.g., the mean of a group)

would fall within approximately 2 SDs of the mean of the population, and there is a 5% probability

that the value would fall in the tails of the normal curve (the extreme ends of the normal curve,

below �2 (�1.96 exactly) SDs [2.5%] or above +2 (+1.96 exactly) SDs [2.5%]). If the groups being

326 CHAPTER 11 Understanding Statistics in Research

compared are from the same population (not significantly different), you would expect the values

(e.g., the means) of each group to fall within the 95% range of values on the normal curve. If the

groups are from (significantly) different populations, you would expect one of the group values to

be outside the 95% range of values. An inferential statistical analysis performed to determine

differences between groups, using a level of significance (a) set at 0.05, would test that expectation. If the statistical test demonstrates a significant difference (the value of one group does not fall

within the 95% range of values), the groups are considered to belong to different populations.

However, in 5% of statistical tests, the value of one of the groups can be expected to fall outside

the 95% range of values but still belong to the same population (a type I error).

Tailedness Nondirectional hypotheses usually assume that an extreme score (obtained because the group with

the extreme score did not belong to the same population) can occur in either tail of the normal

curve (Figure 11-2). The analysis of a nondirectional hypothesis is called a two-tailed test of sig-

nificance. In a one-tailed test of significance, the hypothesis is directional, and extreme statistical

values that occur in a single tail of the curve are of interest (see Chapter 5 for a discussion of direc-

tional and nondirectional hypotheses). The hypothesis states that the extreme score is higher or

lower than that for 95% of the population, indicating that the sample with the extreme score is

not a member of the same population. In this case, 5% of statistical values that are considered

significant will be in one tail, rather than two. Extreme statistical values occurring in the other tail

of the curve are not considered significantly different. In Figure 11-3, which shows a one-tailed

figure, the portion of the curve in which statistical values will be considered significant is the right

tail. Developing a one-tailed hypothesis requires that the researcher have sufficient knowledge

68.3%

95.5%

99.7%

STANDARD DEVIATIONS or Z-Scores

�3 �3�1 0 �1�2

�1.96

�2

�1.96

�2.58 �2.58

Mean Median Mode

FIG 11-1 Normal curve.

327CHAPTER 11 Understanding Statistics in Research

of the variables to predict whether the difference will be in the tail above the mean or in the tail

below the mean. One-tailed statistical tests are uniformly more powerful than two-tailed tests,

decreasing the possibility of a type II error (saying something is not significant when it is).

Type I and Type II Errors According to decision theory, two types of error can occur when a researcher is deciding what the

result of a statistical test means, type I and type II (Table 11-2). A type I error occurs when the null

hypothesis is rejected when it is true (e.g., when the results indicate that there is a significant dif-

ference, when in reality there is not). The risk of a type I error is indicated by the level of signif-

icance. There is a greater risk of a type I error with a 0.05 level of significance (5 chances for error in

100) than with a 0.01 level of significance (1 chance for error in 100).

Significantly different

from mean

Tail

Significantly different

from mean

Tail

Two-tailed test—0.05 level of significance

0.025 0.025

FIG 11-2 Two-tailed test of significance.

Significantly different

from mean

One-tailed test—0.05 level of significance

0.05

FIG 11-3 One-tailed test of significance.

328 CHAPTER 11 Understanding Statistics in Research

A type II error occurs when the null hypothesis is regarded as true but is in fact false. For exam-

ple, statistical analyses may indicate no significant differences between groups, but in reality the

groups are different (see Table 11-2). There is a greater risk of a type II error when the level of

significance is 0.01 than when it is 0.05. However, type II errors are often caused by flaws in

the research methods. In nursing research, many studies are conducted with small samples and

with instruments that do not accurately and precisely measure the variables under study

(Grove et al., 2013; Waltz et al., 2010). In many nursing situations, multiple variables interact

to cause differences within populations. When only a few of the interacting variables are examined,

small differences between groups may be overlooked. This leads to nonsignificant study results,

which can cause researchers to conclude falsely that there are no differences between the samples

when there actually are. Thus the risk of a type II error is often high in nursing studies.

Power: Controlling the Risk of a Type II Error Power is the probability that a statistical test will detect a significant difference that exists (see

Table 11-2). The risk of a type II error can be determined using power analysis. Cohen (1988)

has identified four parameters of a power analysis: (1) the level of significance; (2) sample size;

(3) power; and (4) effect size. If three of the four are known, the fourth can be calculated using

power analysis formulas. The minimum acceptable power level is 0.80 (80%). The researcher deter-

mines the sample size and the level of significance (usually set at a¼0.05). (Chapter 9 provides a detailed discussion of power analysis.) Effect size is “the degree to which the phenomenon is pre-

sent in the population, or the degree to which the null hypothesis is false” (Cohen, 1988, pp. 9-10).

For example, if changes in anxiety level are measured in a group of patients before surgery, with the

first measurement taken when the patients are still at home, and the second taken just before

surgery, the effect size will be large if a great change in anxiety occurs in the group between the

two points in time. If the effect of a preoperative teaching program on the level of anxiety is mea-

sured, the effect size will be the difference in the post-test level of anxiety in the experimental group

compared with that in the comparison group. If only a small change in the level of anxiety is

expected, the effect size will be small. In many nursing studies, only small effect sizes can be

expected. In such a study, a sample of 200 or more is often needed to detect a significant difference

(Cohen, 1988). Small effect sizes occur in nursing studies with small samples, weak study designs,

and measurement methods that measure only large changes. The power level should be discussed

in studies that fail to reject the null hypothesis (or have nonsignificant findings). If the power level

is below 0.80, you need to question the validity of the nonsignificant findings.

Degrees of Freedom The concept of degrees of freedom (df) is important for calculating statistical procedures and inter-

preting the results using statistical tables. Degrees of freedom involve the freedom of a score value

TABLE 11-2 TYPE I AND TYPE II ERRORS

IN REALITY, THE NULL HYPOTHESIS* IS:

DATA ANALYSIS INDICATES TRUE FALSE

Results significant, null hypothesis rejected Type I error (a) Correct decision (power) Results not significant, null hypothesis not rejected Correct decision Type II error (b)

*The null hypothesis is stating that no difference or relationship exists.

329CHAPTER 11 Understanding Statistics in Research

to vary given the other existing scores’ values and the established sum of these scores (Grove et al.,

2013). Degrees of freedom are often reported with statistical results.

USING STATISTICS TO DESCRIBE

Descriptive statistics, introduced earlier, allow researchers to organize numerical data in ways that

give meaning and facilitate insight. In any study in which the data are numerical, data analysis

begins with descriptive statistics. For some descriptive studies, researchers limit data analyses to

descriptive statistics. For other studies, researchers use descriptive statistics primarily to describe

the characteristics of the sample and describe values obtained from the measurement of dependent

or research variables. Descriptive statistics presented in this book include frequency distributions,

percentages, measures of central tendency, measures of dispersion, and standardized scores.

Frequency Distributions Frequency distribution describes the occurrence of scores or categories in a study. For example,

the frequency distribution for gender in a study might be 42 males and 58 females. A frequency

distribution usually is the first method used to organize the data for examination. There are two

types of frequency distributions, ungrouped and grouped.

Ungrouped Frequency Distributions

Most studies have some categorical data that are presented in the form of an ungrouped frequency

distribution, in which a table is developed to display all numerical values obtained for a particular

variable. This approach is generally used on discrete rather than continuous data. Examples of data

commonly organized in this manner are gender, ethnicity, marital status, diagnoses of study sub-

jects, and values obtained from the measurement of selected research and dependent variables.

Table 11-3 is an example table developed for this text; it includes nine different scores obtained

by 50 subjects. This is an example of ungrouped frequencies because each score is represented

in the table with the number of subjects receiving this score.

Grouped Frequency Distributions

Grouped frequency distributions are used when continuous variables are being examined. Many

measures taken during data collection, including body temperature, vital lung capacity, weight,

age, scale scores, and time, are measured using a continuous scale. Any method of grouping results

in loss of information. For example, if age is grouped, a breakdown into two groups, younger than

65 years and older than 65 years, provides less information about the data than groupings of

TABLE 11-3 EXAMPLE OF AN UNGROUPED FREQUENCY TABLE

SCORE FREQUENCY PERCENTAGE

CUMULATIVE

FREQUENCY (f)

CUMULATIVE

PERCENTAGE

1 4 8 4 8

3 6 12 10 20

4 8 16 18 36

5 14 28 32 64

7 8 16 40 80

8 6 12 46 92

9 4 8 N ¼ 50 100

330 CHAPTER 11 Understanding Statistics in Research

10-year age spans. As with levels of measurement, rules have been established to guide classification

systems. There should be at least five but not more than 20 groups. The classes established must be

exhaustive; each datum must fit into one of the identified classes. The classes must be exclusive;

each datum must fit into only one (Grove et al., 2013). A common mistake occurs when the ranges

contain overlaps that would allow a datum to fit into more than one class. For example, a

researcher may classify age ranges as 20 to 30, 30 to 40, 40 to 50, and so on. By this definition,

subjects aged 30, 40, and so on can be classified into more than one category. The range of each

category must be equivalent. For example, if 10 years is the age range, each age category must

include 10 years of ages. This rule is violated in some cases to allow the first and last categories

to be open-ended and worded to include all scores above or below a specified point. Table 11-4

is an example of a grouped frequency distribution for income for registered nurses (RNs), in which

the categories are exhaustive and mutually exclusive.

Percentage Distributions A percentage distribution indicates the percentage of subjects in a sample whose scores fall into a

specific group and the number of scores in that group. Percentage distributions are particularly

useful for comparing the present data with findings from other studies that have different sample

sizes. A cumulative distribution is a type of percentage distribution in which the percentages and

frequencies of scores are summed as one moves from the top of the table to the bottom. Conse-

quently, the bottom category would have a cumulative frequency equivalent to the sample size and

a cumulative percentage of 100 (see Table 11-3). Frequency distributions are also displayed using

tables or graphs (e.g., pie chart, bar chart, line graph). Graphic displays of the frequency distribu-

tion of data from Table 11-3 are presented in Figure 11-4. You might note in the bar and line graphs

that the data distribution forms a normal curve.

Measures of Central Tendency Measures of central tendency frequently are referred to as the midpoint in the data or as an aver-

age of the data. The measures of central tendency are the most concise statement of the nature of

the data in a study. The three measures of central tendency that are commonly used in statistical

analyses are the mode, median, and mean. For a data set that has a normal distribution, these

values are equal (see Figure 11-1); however, they usually are different for data obtained from real

samples.

Mode The mode is the numerical value or score that occurs with greatest frequency; it does not neces-

sarily indicate the center of the data set. The mode can be determined by examination of an

TABLE 11-4 INCOME OF FULL-TIME REGISTERED NURSES (n¼100)

INCOME FREQUENCY (%)

Below $60,000 5 (5%)

$60,000-69,999 20 (20%)

$70,000-79,999 35 (35%)

$80,000-90,000 25 (25%)

Above $90,000 15 (15%)

331CHAPTER 11 Understanding Statistics in Research

Score 4—16%

Score 3—12%

Score 1—8%

Score 9—8% Score 8—12%

Score 5—28%

Score 7—16%

16

14

12

10

8

6

4

2

0

16

14

12

10

8

6

4

2

0

Score 1 Score 3 Score 4 Score 5 Score 7 Score 8 Score 9

Score 1 Score 3 Score 4 Score 5 Score 7 Score 8 Score 9

FIG 11-4 Commonly used graphic displays of frequency distribution.

332 CHAPTER 11 Understanding Statistics in Research

ungrouped frequency distribution of the data. In Table 11-3, the mode is the score of 5, which

occurred 14 times in the data set. The mode can be used to describe the typical subject or identify

the most frequently occurring value on a scale item. The mode is the appropriate measure of cen-

tral tendency for nominal data. A data set can have more than one mode. If two modes exist, the

data set is referred to as bimodal distribution (Figure 11-5). A data set with more than two modes

is said to be multimodal.

Median

The median is the midpoint or the score at the exact center of the ungrouped frequency

distribution—the 50th percentile. The median is obtained by rank-ordering the scores. If the num-

ber of scores is uneven, exactly 50% of the scores are above the median, and 50% are below it. If the

number of scores is even, the median is the average of the two middle scores; thus the median may

not be one of the scores in the data set. Unlike the mean, the median is not affected by extreme

scores in the data (outliers). The median is the most appropriate measure of central tendency for

ordinal data. The median for the data in Table 11-3 is 5.

Mean

The most commonly used measure of central tendency is the mean. The mean is the sum of the

scores divided by the number of scores being summed. Like the median, the mean may not be a

member of the data set. The mean is the appropriate measure of central tendency for interval- and

ratio-level data. However, if the study has outliers, the mean is most affected by these, and the

median might be the measure of central tendency included in the research report. The mean

for the data in Table 11-3 is 5.28.

Measures of Dispersion Measures of dispersion, or variability, are measures of individual differences of the members of the

sample. They give some indication of how scores in a sample are dispersed or spread around the

mean. These measures provide information about the data that is not available from measures of

central tendency. The measures of dispersion indicate how different the scores are or the extent to

which individual scores deviate from one another. If the individual scores are similar, measures of

variability are small, and the sample is relatively homogeneous, or similar, in terms of those scores.

A heterogeneous sample has a wide variation in scores. The measures of dispersion generally used

are range, variance, and standard deviation. Standardized scores may be used to express measures of

dispersion. Scatterplots frequently are used to illustrate the dispersion in the data (discussed later).

Range The simplest measure of dispersion is the range, which is obtained by subtracting the lowest score

from the highest score. The range for the scores in Table 11-3 is calculated as 9�1¼8. The range is a

Mode

FIG 11-5 Bimodal distribution.

333CHAPTER 11 Understanding Statistics in Research

difference score, which uses only the two extreme scores for the comparison. It is a very crude mea-

sure of dispersion but is sensitive to outliers. The range might also be expressed as the lowest to the

highest scores. For the data in Table 11-3, the range might also be expressed as the scores from 1 to 9.

Variance

The variance for scores in a study is calculated with a mathematical equation and indicates the

spread or dispersion of the scores (see Grove et al., 2013, for the equation). The variance can only

be calculated on data at the interval or ratio level of measurement. The numerical value obtained

from the calculation depends on the measurement scale used, such as the laboratory measurement

of fasting blood glucose values or the scale measurement of weights. The calculated variance value

has no absolute value and can be compared only with data obtained using similar measures. Gen-

erally, however, the larger the variance value, the greater the dispersion of scores. The variance for

the data in Table 11-3 is 4.94.

Standard Deviation

The standard deviation (SD) is the square root of the variance. Just as the mean is the average

value, the SD is the average difference (deviation) value. The SD provides a measure of the average

deviation of a value from the mean in that particular sample. It indicates the degree of error that

would result if the mean alone were used to interpret the data. In the normal curve, 68% of the

values will be within 1 SD above or below the mean, 95% will be within 1.96 SDs above or below the

mean, and 99% will be within 2.58 SDs above or below the mean (see Figure 11-1; Grove, 2007).

The SD for the example data presented in Table 11-3 of Kim and colleagues’ (2012) study is 2.22.

The mean is 5.28, so the value of a subject 1 SD below the mean would be 5.28�2.22, or 3.06. The value of a subject 1 SD above the mean would be 5.28+2.22, or 7.50. Therefore approximately 68%

of the sample (and perhaps the population from which it was derived) can be expected to have

values in the range of 3.06 to 7.50, which is expressed as (3.06, 7.50). Extending this calculation

further, the value of a subject 2 SDs below the mean would be 5.28�2.22�2.22¼0.84 and the value of a subject 2 SDs above the mean would be 5.28+2.22+2.22¼9.72. The values for 2 SDs below and above the mean would be expressed as (0.84, 9.72). Using this strategy, the entire

distribution of values can be estimated (Grove, 2007). The value of a single individual can be com-

pared with the value calculated for the total sample (e.g., mean, median, or mode). Standard devi-

ation is an important measure, both for understanding dispersion within a distribution and

interpreting the relationship of a particular value to the distribution.

Confidence Interval When the probability of including the value of the population within an interval estimate is

known, it is referred to as a confidence interval (CI). Calculating a CI involves the use of two

formulas to identify the upper and lower ends of the interval (see Grove et al., 2013, for the for-

mulas). For example, the CI for a study might include a lower value of 15.34 and an upper value of

20.56 and would be expressed as “(15.34, 20.56).” CIs are usually calculated for 95% and 99% inter-

vals. The 95% CI indicates that 95% of the time, the population mean would fall within this inter-

val. Theoretically, we can produce a confidence interval for any population value or parameter of a

distribution. It is a generic statistical procedure. For example, confidence intervals can also be

developed around correlation coefficients and t-test values. Estimation can be used for a single

population or for multiple populations. You will see the use of CIs when reading the results section

of studies.

334 CHAPTER 11 Understanding Statistics in Research

Standardized Scores

Because of differences in the characteristics of various distributions, comparing a value in one dis-

tribution with a value in another is difficult. For example, perhaps you want to compare test scores

from two classroom examinations. The highest possible score in one test is 100 and in the other

it is 70; the scores will be difficult to compare. To facilitate this comparison, a mechanism was

developed to transform raw scores into standardized scores. Numbers that make sense only within

the framework of measurements used within a specific study are transformed into numbers (stan-

dardized scores) that have a more general meaning. Transformation into standardized scores

allows an easy conceptual grasp of the meaning of the score. A common standardized score is called

a Z-score. It expresses deviations from the mean (difference scores) in terms of SD units (see

Figure 11-1). A score that falls above the mean will have a positive Z-score, whereas a score that

falls below the mean will have a negative Z-score. The mean expressed as a Z-score is zero. The SD is

equal to the Z-score. Thus a Z-score of 2 indicates that the score from which it was obtained is 2 SDs

above the mean. A Z-score of �0.5 indicates that the score is 0.5 SD below the mean.

Scatterplots

A scatterplot has two scales, horizontal and vertical. Each scale is referred to as an axis. The vertical

scale is called the y-axis; the horizontal scale is the x-axis. A scatterplot can be used to illustrate the

dispersion of values on a variable. In this case, the x-axis represents the possible values of the var-

iable. The y-axis represents the number of times each value of the variable occurred in the sample.

Scatterplots also can be used to illustrate the relationship between values on one variable and values

on another. Then each axis will represent one variable. For example, if a graph is developed to

illustrate the relationship between subjects’ anxiety and depression scores measured with Likert

scales, the horizontal axis could represent anxiety and the vertical axis could represent depression.

For each unit or subject, there is a value for x and a value for y. The point at which the values of x

and y for a single subject intersect is plotted on the graph (Figure 11-6). When the values for each

4

3

2

1

Plot for one unit

5 10 15 20

Anxiety

Y

X

Vertical axis

Horizontal axis

Ticks

D e p

re s s io

n

Scale units

FIG 11-6 Structure of a plot.

335CHAPTER 11 Understanding Statistics in Research

subject in the sample have been plotted, the degree of relationship between the variables is revealed

(Figure 11-7). If the scatterplot in Figure 11-7 was an example of the relationship between anxiety

and depression, the plot is positive and indicates that as anxiety increases so does depression in the

study subjects.

Understanding Descriptive Statistical Results In published studies, investigators report descriptive statistics in tables and in the narrative of the

results section. Descriptive statistics are used to describe the sample (see earlier) and study vari-

ables. Measures of central tendency (mode, median, and mean) and measures of dispersion (range

and SD) are usually calculated to describe study variables. Also, descriptive and inferential statistics

might be presented together to describe differences or similarities between groups at the start of the

study. Inferential statistical procedures often used for this purpose include the chi-square test for

nominal-level data and the t-test for interval- and ratio-level data. From a perspective of descrip-

tive analyses, the purpose is not to test for causality, but rather to describe the differences or sim-

ilarities between the groups in a study.

FIG 11-7 Example of a scatterplot.

RESEARCH EXAMPLE

Description of Study Variables

Research Study Kim and colleagues’ (2012) study, presented as an example earlier in this chapter, focused on determining the effec-

tiveness of an aquarobic exercise program (independent variable) for patients with osteoarthritis. The dependent or

outcome variables in this study were self-efficacy, pain, body weight, blood lipids, and depression. These variables

were described at the start of the study using means and SDs, and these variables were examined for differences

between the experimental and control groups using the t-test. Table 11-5 presents the results from these analyses,

which indicate that none of the t-tests were significant (p values all>0.05).

336 CHAPTER 11 Understanding Statistics in Research

DETERMINING THE APPROPRIATENESS OF INFERENTIAL STATISTICS IN STUDIES

Multiple factors are involved in determining the appropriateness or suitability of inferential sta-

tistical procedures conducted in a study. Inferential statistics are conducted to examine relation-

ships, make predictions, and determine causality or differences in studies. The inferential statistics

used in a study are determined by the study’s (1) purpose, (2) hypotheses, questions, or objectives,

(3) design, and (4) level of measurement of the variables. Determining the suitability of various

inferential statistical procedures for a particular study is not straightforward. Regrettably, there is

not usually one “right” statistical procedure for a study.

Critical Appraisal The descriptive analysis techniques (mean [M] and SD) were appropriate for the level of measurement of the vari-

ables, which were interval or ratio. Self-efficacy and depression were measured with Likert scales, and the totals of

these scales are often considered interval-level data (Grove et al., 2013; Waltz et al., 2010). Pain was measured with a

visual analog scale that produces at least interval-level data (see Chapter 10); the physiological variables of body

weight and lipids are ratio-level data. These descriptive results were clearly presented in a table and discussed in

the narrative of the results section. However, it would have been helpful to include the range for these variables

to examine for outliers.

The study included two groups (experimental and control), and differences between these two groups were exam-

ined for each of the dependent variables. Differences between the groups were appropriately analyzed with t-tests.

The experimental and control groups were found to have no significant differences in the dependent variables at the

start of the study (p values>0.05). Thus these groups are considered homogeneous or similar for these variables. These results strengthen the study because the groups need to be as similar as possible for the dependent variables at

the start of the study. Thus any significant differences noted at the end of the study are more likely to be a result of the

study intervention than of error.

Implications for Practice The implications of the study findings for practice were discussed earlier in this chapter.

TABLE 11-5 Homogeneity Test of Dependent Variables Between Experimental and Control Groups

Variable

Experimental Group

n ¼ 35ð Þ M �SD

Control Group

n ¼ 35ð Þ M �SD t p

Self-efficacy 1,124.87�206.75 1,166.00�152.31 �0.95 0.345 Pain 6.83�1.92 7.03�1.99 �0.43 0.670 Body weight 60.86�9.48 59.19�5.87 0.86 0.392 Blood lipid levels

Total cholesterol (mg) 212.94�43.47 218.20�39.51 �0.53 0.598 Triglycerides (mg/dL) 157.34�121.25 123.34�60.21 1.49 0.142 HDL cholesterol (mg/dL) 57.06�25.09 64.03�27.47 �1.11 0.272

Depression 32.66�6.78 32.26�7.81 0.22 0.827 HDL, High-density-lipoprotein.

From Kim, I., Chung, S., Park, Y., & Kang, H. (2012). The effectiveness of an aquarobic exercise program for

patients with osteoarthritis. Applied Nursing Research, 25(3), 186.

337CHAPTER 11 Understanding Statistics in Research

Evaluating statistical procedures requires that you make a number of judgments about the

nature of the data and what the researcher wanted to know. You need to determine (1) whether

the data for analysis were treated as nominal, ordinal, or interval or ratio (see Figure 10-2 in

Chapter 10), (2) how many groups were in the study, and (3) whether the groups were paired

(dependent) or independent. You might see statistical techniques identified as parametric or non-

parametric, based on the level of measurement of the study variables. If the variables are measured

at the nominal and ordinal levels, nonparametric analyses are conducted. If variables are at the

interval or ratio level of measurement, and the values of the subjects for the variable are normally

distributed, parametric analyses are conducted (Grove, 2007). Researchers run a computer pro-

gram to determine if the data for variables are normally distributed. Interval and ratio levels of data

are often included together because the analysis techniques are the same whether the data are at the

interval or ratio level of measurement.

In independent groups, the selection of one subject is unrelated to the selection of other sub-

jects. For example, if subjects are randomly assigned to treatment and control groups, the groups

are independent. In paired groups (also called dependent groups), subjects or observations

selected for data collection are related in some way to the selection of other subjects or observa-

tions. For example, if subjects serve as their own control by using the pretest as a control group, the

observations (and therefore the groups) are paired. Also, if matched pairs of subjects are used for

the comparison and treatment groups, the observations are paired or dependent (see Chapter 8).

Researchers sometimes match groups on age and level of illness to control the effect of these demo-

graphic variables in a study. In a study of twins, one twin may be placed in the control group and

the other in the experimental or treatment group. Because they are twins, they are matched on

several variables.

One approach for judging the appropriateness of an analysis technique in a study is to use a

decision tree or algorithm. The algorithm directs you by gradually narrowing the number of

appropriate statistical procedures as you make judgments about the nature of the study and the

data. An algorithm for judging the appropriateness of statistical procedures is presented in

Figure 11-8. This algorithm identifies four factors related to the appropriateness of a statistical

procedure—nature of the research question, level of measurement of the dependent and

research variables, number of groups, and research design. To use the decision tree or algorithm

in Figure 11-8, you would (1) determine whether the research question focuses on differences

or associations (relationships), (2) determine the level of measurement (nominal, ordinal, or

interval/ratio) of the study variables, (3) select the number of groups that are included in the

study, and (4) determine the design, with independent or paired (dependent) samples, that

most closely fits the study you are critically appraising. The lines on the algorithm are followed

through each selection to identify the appropriate statistical procedure listed at the far right in

the figure.

Critical Appraisal Guidelines for Inferential Statistical Analyses When critically appraising the appropriateness of inferential statistical procedures used in

published studies, you must not only be familiar with the statistical procedure used in the

study, but you also must be able to compare that procedure with others that could have

been used, perhaps to greater advantage. Figure 11-8 can be used to determine the appropri-

ateness of the inferential statistical procedures included in a study. The following critical

appraisal guidelines will assist you in assessing the quality of the results presented in published

studies.

338 CHAPTER 11 Understanding Statistics in Research

Nature of Research Question

Differences

Nominal

One Group

One Group

One-sample Chi-square (χ2)

χ2

Fisher’s exact test or χ2

McNemar test

Cochran’s Q statistic

Mann- Whitney U

Wilcoxon signed -rank test

Kruskal- Wallis test

Friedman test

One-sample t-test

Independent samples t-test

Paired samples t-test

One-way analysis of

variance (ANOVA)

Repeated measures ANOVA

Independent samples

Independent samples

Independent samples

Independent samples

Independent samples

Independent samples

Paired samples

Paired samples

Paired samples

Paired samples

Paired samples

Paired samples

Two Group

Two Group

Two Group

One Group

One Group

One Group

More than two groups

More than two groups

More than two groups

Phi, Contingency coefficient, Cramer’s V

Spearman rank order correlation coefficient,

Kendall’s tau, Somer’s D

Pearson product-moment correlation coefficient,

Simple linear regression

Ordinal

Interval/Ratio

Nominal

Ordinal

Interval/Ratio

Associations or

Relationships

Measurement of Dependent Variable or

Research Variable

Number of Groups (or Levels of

Independent Variable)

Recommended Statistic

Research Design

FIG 11-8 Statistical decision tree or algorithm for identifying an appropriate analysis technique. (Modified from Grove, S. K., Burns, N., & Gray, J. R. [2013]. The practice of nursing research: Appraisal, synthesis, and generation of evidence [7th ed.]. St. Louis: Elsevier Saunders, p. 547.)

339CHAPTER 11 Understanding Statistics in Research

USING STATISTICS TO EXAMINE RELATIONSHIPS

Investigators use correlational analyses to identify relationships between or among variables

(Hoare & Hoe, 2013). The purpose of the analysis may be to describe relationships between vari-

ables, clarify the relationships among theoretical concepts, or assist in identifying possible causal

relationships, which then can be tested by analyses examining group differences. All the data for the

analysis need to be from a single population from which values were available on all variables to be

examined in the correlational analysis. Data measured at interval or ratio levels provide the best

information on the nature of the relationship. However, correlational analysis procedures are avail-

able for most levels of measurement. Data for a correlational analysis also need to span the full

range of possible values on each variable used in the analysis. For example, if values for a particular

variable can range from a low of 1 to a high of 9, each of the values from 1 to 9 will probably be

found in subjects in the data set. If all or most of the values are in the middle of that scoring range

(4, 5, and 6) and few or none have extreme values, a full understanding of the relationship cannot

be obtained from the analysis. Therefore large samples with diverse scores are desirable for corre-

lational analyses (Grove et al., 2013).

Pearson Product-Moment Correlation The Pearson product-moment correlation is an inferential analysis technique calculated to deter-

mine relationships among variables. Bivariate correlation measures the extent of the relationship

between two variables. Data are collected from a single sample, and measures of the two variables

to be examined must be available for each subject in the data set. Less commonly, data are obtained

from two related subjects, such as breast cancer incidence in mothers and daughters. Correlational

analysis provides two pieces of information about the data—the nature of a relationship (positive

or negative) between the two variables and the magnitude (or strength) of the relationship.

? CRITICAL APPRAISAL GUIDELINES Inferential Statistical Analyses Used in Studies

The following questions will assist you in critically appraising the inferential statistical analyses and their results in

studies. The critical appraisals of inferential statistical analysis techniques provided in the rest of this chapter are

guided by the following questions:

1. Were the appropriate inferential analysis techniques performed to address the study purpose or objectives,

questions, or hypotheses? If so, was the focus on the analyses’ relationships, prediction, and/or differences?

2. Was the analysis technique appropriate for the level of measurement of the data (nominal, ordinal, or interval

or ratio) and study design? Use Figure 11-8 to help you determine if the appropriate analysis technique

was used.

3. Were the results from the analyses clearly presented and appropriately interpreted? The American Psycho-

logical Association (APA, 2010) and Hoare and Hoe (2013) have provided detailed discussions on how to

report research results in tables, figures, and narrative.

4. Did the researchers identify the level of significance or a used in the study? Did the findings show statistically significant differences?

5. Were the effect size and power presented for each nonsignificant finding? Was the power adequate for the

study, at least 0.80 or stronger, or was there a potential for a type II error? (See earlier discussion of types I and

II errors and Table 11-2.)

6. Should additional analyses have been conducted? Provide a rationale for your answer (Fawcett & Garity, 2009;

Grove et al., 2013; Hoare & Hoe, 2013; Hoe & Hoare, 2012; Plichta & Kelvin, 2013).

340 CHAPTER 11 Understanding Statistics in Research

Scatterplots sometimes are presented to illustrate the relationship graphically (see Figure 11-7).

The outcomes of correlational analyses are symmetrical, rather than asymmetrical. Symmetrical

means that the analysis gives no indication of the direction of the relationship. It is not possible to

establish from correlational analysis whether variable A leads to or causes variable B, or that B

causes A. Thus the focus of correlational analysis techniques is examining relationships, not deter-

mining cause and effect.

Interpreting Pearson Correlation Analysis Results The outcome of the Pearson product-moment correlation analysis is a correlation coefficient (r)

with a value between �1 and +1. This r value indicates the degree of relationship between the two variables. A value of 0 indicates no relationship. A value of r¼�1 indicates a perfect negative (inverse) correlation. In a negative relationship, a high score on one variable is correlated with

a low score on the other variable. A value of r¼+1 indicates a perfect positive relationship. In a positive relationship, a high score on one variable is correlated with a high score on the other

variable. A positive correlation also exists when a low score on one variable is correlated with a low

score on the other variable. The variables vary or change in the same direction, either increasing or

decreasing together. As the negative or positive values of r approach 0, the strength of the relation-

ship decreases (Grove, 2007).

Traditionally, an r value of less than 0.3 or �0.3 is considered to indicate a weak relationship and a value between 0.3 and 0.5 or �0.3 and �0.5 indicates a moderate relationship; if the r value is above 0.5 or �0.5, it is considered a strong relationship (Grove et al., 2013). However, this inter- pretation of the r value depends to a great extent on the variables being examined and the situation

in which they were measured. Therefore interpretation requires some judgment on the part of the

researcher.

When Pearson’s correlation coefficient is squared (r 2 ), the resulting number is the percentage of

variance explained by the relationship. Even when two variables are related, values of the two vari-

ables will not be a perfect match. For example, if two variables show a strong positive relationship, a

high score on one variable can be expected to be associated with a high score on the other variable.

However, a subject who has the highest score on one value will not necessarily have the highest

score on the other variable. Thus r 2 indicates the variance that is known by correlating two vari-

ables (Grove, 2007).

There will be some variation in the relationship between values for the two variables for indi-

vidual subjects. Some of the variation in values is explained by the relationship between the two

variables and is called explained variance, which is indicated by r 2 and is expressed as a percentage.

For example, researchers may state that the relationship of the two variables anxiety and depression

in their study is r¼0.6, and r2¼0.36 x 100%¼36%. Thus the explained variance is 36% for the variables anxiety and depression, which means that patients’ anxiety scores can explain 36% of the

variance in their depression scores. However, part of the variation is the result of factors other than

the relationship and is called unexplained variance. In the example provided, 100%�36% (explained variance)¼64% (unexplained variance). Therefore 64% of the variation in scores is a result of something other than the relationship studied, perhaps variables not examined in

the study. A strong correlation has less unexplained variance than a weak correlation.

There has been a tendency to disregard weak correlations in nursing research. This approach

can result in overlooking a relationship that may actually have some meaning within nursing

knowledge if the relationship is examined in the context of other variables. Three common reasons

for this situation, which is similar to that of a type II error, have been recognized. First, many nurs-

ing measurements are not powerful enough to detect fine discriminations. Some instruments may

341CHAPTER 11 Understanding Statistics in Research

not detect extreme scores, and a relationship may be stronger than that indicated by the crude

measures available. Second, correlational studies must have a wide range of scores for relationships

to be detected. If the study scores are homogeneous or the sample is small, relationships that exist

in the population may not show up as clearly in the sample. Third, in many cases, bivariate analysis

does not provide a clear picture of the dynamics in the situation. A number of variables can be

linked through weak correlations, but together they provide increased insight into situations of

interest. Statistical procedures (e.g., regression analysis [see later]) are available for examining

the relationships among multiple variables simultaneously (Plichta & Kelvin, 2013).

Testing the Significance of a Correlation Coefficient Before inferring that the sample correlation coefficient applies to the population from which the

sample was taken, statistical analysis must be performed to determine whether the coefficient is

significantly different from zero (no correlation). With a small sample, a very high correlation coef-

ficient can be nonsignificant. With a very large sample, the correlation coefficient can be statisti-

cally significant when the degree of association is too small to be clinically important. Therefore in

judging the significance of the coefficient, both the size of the coefficient and its statistical signif-

icance need to be considered.

RESEARCH EXAMPLE

Correlation Results

Research Study Bingham and colleagues (2009) conducted a descriptive correlational study examining the relationships of obesity

and cholesterol in a sample of 4013 fourth-grade children in three different countries. The purpose of this study was

to describe, correlate, and compare “two risk factors for future CVD [cardiovascular disease] in United States (U.S.),

French, and Japanese children. Total serum cholesterol and two measures of overweight, including BMI [body mass

index] and body fat percentage, were examined in children 9 to 10 years of age from Japan, France, and the U.S.

(Whites and Blacks)” (Bingham et al., 2009, p. 316). The researchers correlated BMI with total cholesterol for males

and females in the three countries and presented their results in a table (Table 11-6).

TABLE 11-6 Correlation of Body Mass Index with Total Cholesterol

France (N¼570)

Japan (N¼1865)

U.S. White (N¼1226)

U.S. Black (N¼324)

Males

Pearson r 0.02 0.17 0.24 0.29

p Value 0.6960 0.0001 0.0001 0.0002

Females

Pearson r 0.12 0.12 0.22 -0.14

p Value 0.0494 0.0004 0.0001 0.0822

NOTE: The number of subjects varies slightly for each variable because of some missing data. From Bingham, M. O., Harrell, J. S., Takada, H., Washino, K., Bradley, C., Berry, D., et al. (2009). Obesity and

cholesterol in Japanese, French, and U.S. children. Journal of Pediatric Nursing, 24(4), 318.

342 CHAPTER 11 Understanding Statistics in Research

Factor Analysis Factor analysis examines interrelationships among large numbers of variables and disentangles

those relationships to identify clusters of variables that are most closely linked. Intellectually,

you might do this by identifying categories and sorting the variables according to your judgment

of the most appropriate category. Factor analysis sorts the variables into categories according to

how closely related they are to the other variables. Closely related variables are grouped together

into a factor. Several factors may be identified within a data set. Once the factors have been iden-

tified mathematically, the researcher must interpret the results by explaining why the analysis

grouped the variables in a specific way. Statistical results will indicate the amount of variance

in the data set that can be explained by a particular factor and the amount of variance in the factor

that can be explained by a particular variable.

Factor analysis aids in the identification of theoretical constructs; it is also used to confirm the

accuracy of a theoretically developed construct. For example, a theorist may state that the concept

Critical Appraisal Bingham and associates (2009) conducted a Pearson product-moment correlation analysis to determine the

relationships between BMI and total cholesterol for males and females from three different countries. This analytical

technique was used to address the study purpose of determining the relationship between the BMI and total

cholesterol. Because BMI and total cholesterol are both measured at the ratio level, Pearson’s correlational analysis

is the appropriate technique for examining relationships between these two variables. The researchers clearly

presented the results of the correlation of BMI with total cholesterol in a table format (APA, 2010). The table

includes the group size (n) for each country and the p value for each correlation value (r). If the p values are less

than or equal to a¼0.05, then the correlations are significant. Table 11-6 includes six significant correlations and two nonsignificant correlations. The researchers noted that the numbers of subjects varied for each

variable because of missing data. They might have expanded on the reasons for the missing data in the narrative

of the article.

As part of the critical appraisal, you are also encouraged to interpret the results from this table. Six of the corre-

lations or r values are significant, with a¼0.05 indicating that there is a statistically significant relationship between BMI and total cholesterol for the three countries. The strongest relationship was for U.S. Black males (r¼0.29) and the weakest relationship was for French males (r¼0.02; Bingham et al., 2009). However, all the correlation values are small or less than 0.30 (Grove, 2007). Even the largest correlation at r¼0.29 only explains 8.4% of the variance between BMI and total cholesterol. This is calculated by r

2�100%¼0.292�100%¼0.084�100%¼8.4%. The unexplained variance in this relationship is 100%�8.4%¼91.6%. Thus most of the correlational results in Table 11-6 are statistically significant but the clinical importance is still in question. Clinical importance is discussed

in greater detail later in this chapter.

Implications for Practice Bingham and co-workers (2009) reached the following conclusion:

“It appears that the relationship between obesity [BMI] and total cholesterol may vary by culture or ethnicity

and by gender, indicating the need for more culture- and gender-specific studies in children to evaluate the

relative importance of these common risk factors for developing CVD. A better understanding of the impact

of culture and gender on obesity and cholesterol levels in children will help nurse clinicians as they assess

children for risk factors for CVD and will provide information that may be used to develop culturally specific

interventions to reduce these risk factors. It is important to monitor BMI and cholesterol in children 9-10 years

old; however, additional research is needed to determine the impact of these two variables on the future

development of CVD.” (Bingham et al., 2009, p. 320)

343CHAPTER 11 Understanding Statistics in Research

(or construct) of “hope” consists of the following elements: (1) anticipation of the future;

(2) belief that things will work out for the best; and (3) optimism. Ways to measure these three

elements can be developed. The measurement instrument operationalizes the theoretical con-

struct, such as hope. A factor analysis can be conducted on the data to determine whether subject

responses clustered into these three groupings identified for the concept hope.

Factor analysis is frequently used in the process of developing measurement instruments, par-

ticularly those related to psychological variables, such as attitudes, beliefs, values, and opinions

(Grove et al., 2013). Factor analysis is used to examine the construct validity of a scale for the pop-

ulation studied. For example, factor analysis might be used to examine the construct validity of a

multi-item Likert scale to measure hope in a group of older adults. We want to provide you with

some idea of the meaning of factor analysis when you see it in research reports.

USING STATISTICS TO PREDICT OUTCOMES

The ability to predict future events is becoming increasingly more important worldwide. People

are interested in predicting who will win the football game, what the weather will be like next week,

or which stocks are likely to increase in value in the near future. In nursing practice, as in the rest of

society, the ability to predict is crucial. For example, nurse researchers would like to be able to

predict the length of a hospital stay for patients with illnesses of different severity, as well as

the responses of patients with a variety of characteristics (e.g., age, gender, level of education)

to nursing interventions. Nurses need to know which variables play an important role in predicting

health outcomes in patients and families (Doran, 2011). For example, variables of BMI, blood lipid

levels, and smoking pack-years (number of years smoking times the number of packs smoked per

day) have been used to predict the outcome of the incidence of myocardial infarction (MI). Pre-

dictive analyses are based on probability theory, not on decision theory. Prediction is one approach

for examining causal relationships between or among variables.

Regression Analysis Regression analysis is used to predict the value of one variable when the value of one or more

other variables is known. The variable to be predicted in a regression analysis is referred to as

the dependent or outcome variable. The dependent variable is usually measured at the interval

or ratio level. The goal of the analysis is to explain as much of the variance in the dependent var-

iable as possible. In regression analysis, variables used to predict values of the dependent variable

are referred to as independent variables. When one independent variable is used to predict a

dependent variable, the analytical procedure used is simple linear regression. Multiple regression

is used to analyze study data that include two or more independent variables. In regression anal-

ysis, the symbol for the dependent variable is Y, and the symbol for the independent variable(s)

is X. Scatterplots and a bivariate correlation matrix are often developed before regression analysis is

performed to examine the relationships that exist among the variables. The purpose of the regres-

sion analysis is to develop a line of best fit that will best reflect the values on the scatterplot. The

line of best fit is often illustrated as an overlay on the scatterplot (Figure 11-9). Many regression

analysis techniques have been developed to analyze various types of data. One type, logistic regres-

sion, was developed to predict values of a dependent variable measured at the nominal level. Logis-

tic regression is being used with increasing frequency in nursing studies. This type of regression can

test whether a patient responds or did not respond to the intervention (Grove et al. 2013; Hoare &

Hoe, 2013; Plichta & Kelvin, 2013).

344 CHAPTER 11 Understanding Statistics in Research

Interpreting Results

The outcome of a regression analysis is the regression coefficient, R. When R is squared (R 2 ),

it indicates the amount of variance in the data that is explained by the equation (Grove, 2007).

When more than one independent variable is being used to predict values of the dependent var-

iable, R 2 is sometimes referred to as the coefficient of multiple determination. The test statistic

used to determine the significance of a regression coefficient may be t (from t-test) or F (from the

analysis of variance [ANOVA]). Small sample sizes decrease the possibility of obtaining statistical

significance. Values for R 2 and t or F are reported with the results of a regression analysis. The

calculated coefficient values may also be expressed as an equation. Many studies using regression

analysis are complex, including multiple independent variables and involving more than one

regression procedure. Understanding the discussion of complex results requires reading each sen-

tence carefully for comprehension, looking up unfamiliar terms, and determining the statistical

significance of the results.

FIG 11-9 Overlay of scatterplot and best-fit line.

RESEARCH EXAMPLE

Regression Analysis

Research Study Excerpt Dickson, Howe, Deal, and McCarthy (2012) conducted a descriptive, predictive correlational study to determine

how predictive job characteristics (job demands, job control, workplace support) were of self-care adherence behav-

iors (adherence to medication, diet, exercise, and symptom monitoring) in older workers with CVD. The steps of

this study are presented in Chapter 2, and Figure 2-2 illustrates a copy of the study framework model that was tested

using regression analysis. Dickson and colleagues (2012) presented their multiple regression analysis results, as

shown in Table 11-7. Continued

345CHAPTER 11 Understanding Statistics in Research

RESEARCH EXAMPLE—cont’d

They provided the following discussion of those results:

“Regression analysis was used to assess the relationship among job characteristics (psychological job

demands, job control, and workplace support by supervisors) and self-care adherence behaviors, controlling

for depression and physical functioning (see Table 11-7). Depression and physical functioning were entered

at step 1 [and] explained 11.9% [R2¼.119; see Table 11-7] of the variance in adherence to treatment recom- mendations. After entry of the job characteristic variables of psychological job demands, job control, and

workplace support by supervisors at step 2, the total variance explained was 21.4% (p<.0001)

[R 2¼.214].” (Dickson et al., 2012, pp 9-10)

Critical Appraisal Dickson and associates (2012) clearly stated their study purpose and objectives that supported the use of regression

analysis to examine their use of job characteristics to predict the outcome of self-care adherence behaviors in these

older working adults. Regression analysis is appropriate to predict a dependent variable (self-care adherence behav-

iors) using independent variables (psychological job demands, job control, workplace support, depression, and

physical functioning). The results of the multiple regression analysis were clearly presented in Table 11-7 and dis-

cussed in the article narrative. The study identified three independent variables, physical functioning (p¼0.04), psychological job demands (p¼0.049), and workplace supervisor support (p¼0.035; see the p value column in Table 11-7) to be significant predictors of the dependent variable of self-care adherence behaviors. The results of

the study explained 21.4% (R 2�100%) of the variance in self-care adherence behaviors in older workers with CVD.

Implications for Practice Dickson and co-workers (2012) identified the following recommendations for further research and implications for

practice:

“Research to develop and test interventions to foster worksite programs that facilitate self-care behaviors

among older workers with CVD is needed. Research efforts should include the objective measurement of

adherence and self-care.. . . Programs that target general self-care such as diet and exercise. . .are indicated

to address the needs across the working population. Nurses with expertise in occupational health are well

suited to champion these efforts. In addition, because job characteristics may interfere with self-care. . .

nurses should assess job demands and include stress reduction as part of patient counseling for workers

with CVD during routine office visits.” (Dickson et al., 2012, p. 12)

TABLE 11-7 Regression of Psychological Job Demands and Workplace Support on Self-Care Adherence Behaviors

b 95% CI of b p Value Total R2 Cohen’s f2

Model Controls

Depression �.870 (�1.687 to �.054) 0.111 .119 .136* Physical functioning .219 (.011 to .447) 0.040

+ Job Characteristics

Psychological job demands �.525 (�1.049 to �.002) 0.049 .214 .272{ Job control .046 (�.321 to .412) 0.803 Workplace support 1.350 (�.095 to 2.605) 0.035 CI, confidence interval.

*Considered a medium effect size. {Medium to large effect size.

From Dickson, V. V., Howe, A., Deal, J., & McCarthy, M. M. (2012). The relationship of work, self-care, and

quality of life in a sample of older working adults with cardiovascular disease. Heart & Lung, 41(1), 10 (Table 2 in

the article).

346 CHAPTER 11 Understanding Statistics in Research

USING STATISTICS TO EXAMINE DIFFERENCES

Inferential statistics are used to examine differences between or among groups, such as examining

difference between experimental and control groups on selected demographic variables (see

Table 11-1 in this chapter’s first research example). Differences are also examined among other types

of groups, such as examining differences of blood lipid values between males and females or differ-

ences in fasting blood sugar (FBS) and hemoglobin A1c (HgbA1c) levels among Caucasian, African

American, American Indian, and Hispanic racial and ethnic groups. Statistical procedures used to

examine differences are also conducted to examine causality of the independent variable on the

dependent variable. Causality is a way of knowing that one event causes another. Because they

can be used to understand the effects of interventions, statistical procedures that examine causality

are critical to the development of nursing science. These statistics examine causality by testing for

significant differences between or among groups, such as the differences between the experimental

and control groups. The statistical procedures used to examine differences included in this text are

the chi-square test of independence, t-test, ANOVA, and analysis of covariance (ANCOVA). The t-

test is used to examine differences between two groups and the chi-square test, ANOVA, and

ANCOVA can be used to examine differences among three or more groups. The chi-square test

is used to analyze nominal or ordinal levels of data, and ANOVA and ANCOVA are conducted to

analyze interval and ratio levels of data (Grove et al., 2013; Hoare & Hoe, 2013).

When differences are examined among three groups, posthoc analyses are conducted to deter-

mine which of the groups are significantly different. The chi-square test and ANOVA indicate sig-

nificant differences among the groups but do not specify which groups are different. For example, a

study may examine four occupational groups of workers who are smokers to determine differences

in smoking behaviors among the groups. Chi-square analysis or ANOVA may show significant

differences among the groups, but posthoc analyses are needed to identify which of the four groups

are significantly different. If a study has three or more groups being compared for differences,

researchers usually identify the type of posthoc analysis conducted and discuss the results.

Chi-Square Test of Independence The chi-square test of independence determines whether two variables are independent or

related; the test can be used with nominal or ordinal data. The procedure examines the frequencies

of observed values and compares them with the frequencies that would be expected if the data

categories were independent of each other. The procedure is not very powerful; thus, the risk

of a type II error is high (outcome of the study is nonsignificant when significant differences actu-

ally exist). Large sample sizes are needed to decrease the risk of a type II error. Most studies using

this procedure place little importance on results in which no differences are found. Researchers

frequently perform multiple chi-square tests in a sample. However, results generally are presented

only when a chi-square analysis shows a significant difference.

Interpreting Results

Often, the first reaction to a sentence about “significant differences” by those unfamiliar with read-

ing statistical results is panic. However, a sentence that looks dense with statistics provides a great

deal of information in a small amount of space. For example, in the component “(w2 [1]¼18.10, p¼0.001),” the author is using chi-square (w2) analysis to compare two groups on a selected var- iable, such as the presence or absence of chronic illness. The author provides the degrees of freedom

(df¼[1]), so that the reader can validate the accuracy of the results using a statistical chi-square table (see the text by Grove et al., 2013, p. 683, for a w2 statistical table). The numerical value after the first equal sign, 18.10, is the chi-square (w2) value obtained from calculating the chi-square

347CHAPTER 11 Understanding Statistics in Research

equation (probably using a computer). This value has no inherent meaning other than to deter-

mine significance on a statistical table. As noted earlier, the symbol p is the abbreviation for prob-

ability. The groups were significantly different because p¼0.001, which is below the level of significance set at a¼0.05. The phrase also indicates that the probability is 1 in 1000 that these groups come from the same population. Therefore the two groups are significantly different

because there is only 1 chance in 1000 that the study results are in error.

If a study variable has only two categories, such as the presence or absence of chronic illness, the

researchers know the location of the significant difference. However, the exact location of specific

differences among more than two categories of variables cannot be determined from chi-square

analysis alone. Chi-square analysis identifies whether there is a significant difference, and posthoc

analyses can be used to identify the categories in which the significant differences occur.

RESEARCH EXAMPLE

Chi-Square Results

Research Study Lavoie-Tremblay and colleagues (2008) examined the influence of psychosocial work environment variables on the

psychological health of recently educated nurses. The psychosocial work environment variables included effort-

reward imbalance, lack of social support from colleagues and superiors, high psychological demand, low decision

latitude, and elevated job strain. The nurse participants were divided into two dichotomous groups, those with high

psychological distress and those with low psychological distress. The researchers conducted chi-square analysis to

determine differences between the two groups of nurses for the psychosocial work environment variables and pre-

sented their findings in Table 11-8. Lavoie-Tremblay and associates (2008) noted that the two psychological distress

risk groups were significantly different on three psychosocial work environment variables: (1) effort-reward balance

(w2 [1]¼30.471, p¼0.000); (2) high psychological demand (w2 [1]¼17.625, p¼0.000); and (3) elevated job strain (w2 [1]¼8.96, p¼0.003).

Critical Appraisal Chi-square analysis isappropriate to examine differencesbetweenthetwogroups ofnursesthat were dichotomized into

those with high andlow psychologicaldistress. The chi-square resultswere clearly presented in Table 11-8and discussed

in the text of the article. The chi-square resultsincluded the w2 values, the df (df¼1 for the two groups), and the p values (probability of obtaining each chi-square value). The * or { indicated the level of significance of the chi-square value. Three of the psychosocial work environment variables were significantly linked to psychological distress. Because only

two levels or groups of psychological distress risk (high and low) were examined, no posthoc analyses were required.

TABLE 11-8 Chi-Square Analysis of Psychosocial Work Environment Dimensions and Psychological Distress

Psychological Distress and Psychosocial Work Environment Variables High n Low n x2 df p Value

Effort-reward imbalance 101 79 30.471 {

1 0.000

Lack of social support from colleagues and superiors 84 93 2.443 1 0.118

High psychological demand 87 71 17.625 {

1 0.000

Low decision latitude 83 96 1.317 1 0.251

Elevated job strain 51 39 8.960* 1 0.003

*p¼0.05 { p¼0.01 From Lavoie-Tremblay, M., Wright, D., Desforges, N., Gelinas, C., & Marchionni, C., Drevniok, U. (2008).

Creating a healthy workplace for new-generation nurses. Journal of Nursing Scholarship, 40(3), 294.

348 CHAPTER 11 Understanding Statistics in Research

t-Test One of the most common analyses used to test for significant differences between two samples is the

t-test. The t-test is used to examine group differences when the variables are measured at the interval

or ratio level of measurement. A variety of t-tests have been developed for various types of samples.

For example, when independent groups are being compared, the t-test for independent samples is

used. For paired or dependent groups, the t-test for paired samples is used (see Figure 11-8).

Sometimes researchers misuse the t-test by conducting multiple t-tests to examine differences in

various aspects of data collected in a study. This misapplication will result in an escalation of sig-

nificance that increases the risk of a type I error (saying that something is significant when it is not).

The Bonferroni procedure, which controls for the escalation of significance, may be used when

multiple t-tests must be performed on different aspects of the same data.

Interpreting Results The result of the mathematical calculation is a t statistic. This statistic is compared with the t values

in a statistical table (see Grove et al., 2013, pp. 677-678). The table is used to identify the critical

value of t. If the computed statistic is greater than or equal to the critical value, the groups are

significantly different.

Implications for Practice Lavoie-Tremblay and associates (2008) identified the following implications for practice and suggestions for further

research:

“As the current worldwide nursing labor shortage is expected to grow worse, retention strategies are needed

that will be focused on the psychological health of new generation nurses by targeting the psychosocial work

environment. Nursing managers need to revise or develop retention and workplace health-promotion strat-

egies, tailored specifically to next generations, to temper the effect of the nursing shortage. Research is

needed on the meaning of reward at work for nurses from Generation Y. How is the effort/reward imbalance

perceived? Can the way care is organized be changed to increase perceived rewards in the context of a short-

age of healthcare providers and limited financial resources?. . . Nurse managers play a critical role in continu-

ing to strive towards improving work environments so that new nurses do not forget the heart and soul of

nursing and do remain committed to the ideals of caring that led them to the profession in the

first place.” (Lavoie-Tremblay et al., 2008, p. 296)

RESEARCH EXAMPLE

t-Test

Research Study Kim and co-workers (2012) conducted t-tests for independent samples to determine differences between the exper-

imental and control groups in their study. This study was introduced earlier in this chapter and focused on deter-

mining the effects of the independent variable of an aquarobic exercise program on the dependent variables of

self-efficacy, pain, body weight, blood lipids, and depression of patients with osteoarthritis. This study was con-

ducted using a quasi-experimental pretest–post-test design with a nonequivalent control group (see Chapter 8

for a model of this design). Study participants were randomly assigned to the experimental or control group, result-

ing in independent groups. The two groups were not significantly different on the pretest, indicating that the groups

were similar for the dependent variables at the start of the study (see Table 11-5 of Kim and associates’ study). The

experimental group received the exercise program for 12 weeks and then the post-tests were conducted. The results

of the t-tests are presented in Table 11-9. The experimental and control groups were significantly different on the

post-tests for all dependent variables because the p values were less than a¼0.05. Continued

349CHAPTER 11 Understanding Statistics in Research

RESEARCH EXAMPLE—cont’d

Critical Appraisal Kim and co-workers (2012) clearly presented the results of their t-tests for independent samples in tables for the

pretests (see Table 11-5) and post-tests (see Table 11-9). The t-test analysis technique was appropriate because the

focus of the study was to determine differences between the experimental and control groups for selected dependent

variables measured at the interval or ratio level (Grove et al., 2013; Plichta & Kelvin, 2013). There were significant

differences between the two groups for all dependent variables (self-efficacy, pain, body weight, blood lipids, and

depression). The lack of nonsignificant findings indicated adequate power to detect group differences—no type II

errors. The significant findings support the effectiveness of the aquarobic exercise program in improving outcomes

for patients with osteoarthritis. However, conducting multiple t-tests without the Bonferroni procedure raises a

concern about an increased risk for a type I error. The study results would have been strengthened by including

the Bonferroni correction for multiple t-tests.

Implications for Practice The implications of the study findings for practice were discussed earlier in this chapter.

TABLE 11-9 Changes in Dependent Variables between Experimental and Control Groups

Variables Pretest M�SD

Post-Test M�SD

Difference M�SD t p

Self-efficacy

Experimental (n¼35) 1124.87�206.75 1251.46�219.40 126.59�22.77 4.79 0.001 Control (n¼35) 1166.00�152.31 1018.65�224.08 �147.35�61.31

Pain

Experimental (n¼35) 6.83�1.92 6.14�1.80 �0.69�1.7 �2.37 0.021 Control (n¼35) 7.03�1.99 7.26�1.92 0.23�1.5

Body weight

Experimental (n¼35) 60.86�9.48 60.10�8.91 �0.76�1.19 �2.59 0.012 Control (n¼35) 59.19�5.87 59.15�5.86 �0.04�1.04

Blood lipids

Total cholesterol (mg)

Experimental (n¼35) 212.95�43.47 195.00�33.04 �17.94�5.9 �2.10 0.040 Control (n¼35) 218.20�39.51 219.46�40.20 1.26�7.0

Triglycerides (mg)

Experimental (n¼35) 157.34�121.25 135.94�80.97 �21.40�9.6 �2.26 0.027 Control (n¼35) 123.34�60.21 128.51�55.83 5.17�6.8

HDL Cholesterol (mg)

Experimental (n¼35) 57.06�25.09 58.92�26.01 1.86�1.2 2.54 0.014 Control (n¼35) 64.03�27.47 60.60�26.04 �3.43�1.7

Depression

Experimental (n¼35) 32.66�8.05 29.94�7.25 �2.72�1.5 �3.20 .002 Control (n¼35) 32.26�4.93 37.53�9.67 5.27�1.9

From Kim, I., Chung, S., Park, Y., & Kang, H. (2012). The effectiveness of an aquarobic exercise program for

patients with osteoarthritis. Applied Nursing Research, 25(3), p. 187 (Table 5 from the article).

350 CHAPTER 11 Understanding Statistics in Research

Analysis of Variance (ANOVA) Analysis of variance (ANOVA) is a parametric statistical technique used to examine differences

among three or more groups. Because this is a parametric analysis, the variables must be measured

at the interval or ratio level. There are many types of ANOVA; some are developed for analysis of

data from complex experimental designs (Grove et al., 2013; Plichta & Kelvin, 2013). Rather than

focusing just on differences between means, ANOVA tests for differences in variance. One source of

variance is the variance within each group, because individual scores in the group will vary from

the group mean. This variance is referred to as the within-group variance. Another source of var-

iance is the variation of the group means around the grand mean, referred to as the between-group

variance. The assumption is that if all the samples are taken from the same population, these two

sources of variance will exhibit little difference. When these two types of variance are combined,

they are referred to as the total variance.

Interpreting Results The results of an ANOVA are reported as an F statistic. The F distribution table is used to deter-

mine the level of significance of the F statistic. (F statistical tables are provided in the text by

Grove et al., 2013, pp. 680-682.) If the F statistic is equal to or greater than the appropriate table

value, there is a statistically significant difference between the groups. If only two groups are

being examined, the location of a significant difference is clear. However, if more than two groups

are under study, it is not possible to determine from the ANOVA where the significant differences

occur. Therefore posthoc analyses are conducted to determine the location of the differences

among groups. The frequently used posthoc tests are the Bonferroni procedure and the

Newman-Keuls’, Tukey’s honestly significantly difference (HSD), Scheffé’s, and Dunnett’s tests

(Grove et al., 2013).

RESEARCH EXAMPLE

ANOVA

Research Study In a study introduced earlier in this chapter by Bingham and colleagues (2009), the researchers examined the rela-

tionship of obesity and cholesterol in French, Japanese, and U.S. children (see Table 11-6). They also examined dif-

ferences among their four study groups (French, Japanese, and U.S. White and Black children) for the variables of

height, weight, BMI, body fat percentage, and cholesterol using an ANOVA. The researchers reported their findings

in Table 11-10, which included the mean and SD for each variable for each of the four groups, along with the

ANOVA results. The ANOVA results included an F value and a p value that indicated the significance of the results.

For example, for the variable of height, F¼23.3 and p¼0.0001; this is a statistically significant result because p is less than a¼0.05. The ANOVA results demonstrate significant differences among the four groups for all variables (height, weight, BMI, body fat percentage, and cholesterol).

Continued

351CHAPTER 11 Understanding Statistics in Research

RESEARCH EXAMPLE—cont’d

Critical Appraisal Bingham and associates (2009) conducted their study for the purpose of determining differences among four groups

of children (French, Japanese, U.S. Black, and U.S. White) on the variables of height, weight, BMI, body fat per-

centage, and total cholesterol. These study variables were measured at the ratio level of measurement. ANOVA

is the appropriate analysis technique to use with two or more study groups and for variables measured at least

at the interval level of measurement. They clearly presented their ANOVA results in table format and discussed these

results in the results section of their article.

“The U.S. Black children were the tallest, followed by French, U.S. White, and Japanese participants, with

minimal differences in height between the French and U.S. White children. Weight was highest in the U.S.

Black children and lowest in French children. BMI was highest in U.S. Black children, followed by U.S. White,

Japanese, and French children. Body fat percentage was highest in U.S. White children and lowest in French

children. Findings were quite different for total cholesterol, which was highest in French children and lowest

in U.S. White children.” (Bingham et al., 2009, p. 317)

The researchers did not discuss conducting a posthoc analysis to determine where the significant differences were

among the four groups (French, Japanese, and U.S. Black and White children) for the study variables. This study

would have been strengthened by a discussion of posthoc analysis to determine where the significant differences

occurred among the four groups.

Implications for Practice Bingham and co-workers (2009) noted the following findings from their study:

“Japanese and French children were significantly leaner than U.S. children (Black and White), with U.S. Black

children having the highest BMI (19.2) and U.S. White children the highest body fat percentage (23.1%).. . .

The noted increase in childhood obesity in the United States has been described as resulting from a combi-

nation of factors including biological, social, and environmental that may vary and interact differently by coun-

try, culture, and race/ethnicity.. . . The results of our comparison reinforce the need for standards to assess

obesity using the same methods of measurement. This uniformity would enable researchers and clinicians to

better document and understand differences between countries or ethnic groups and provide more consis-

tency to assess change over time.” (Bingham et al., 2009, pp. 318-319)

These researchers recommended using the BMI as the best measure of overweight children, but acknowledged that

the cutoff point for risk of or actual clinical complications is still unclear. They recommended additional studies of

children in the United States and other countries to determine the link of obesity and total cholesterol with CVD.

The QSEN (2013) implication is that the BMI is the best evidence-based measure to identify overweight children

and should be monitored by nurses and other healthcare providers.

TABLE 11-10 BMI, Body Fat, and Cholesterol by Group

Variables France (n¼570)

Japan (n¼1865)

U.S. Whites (n¼1226)

U.S. Blacks (n¼324) f p

Height (cm) 137.5�6.6 136.4�6.4 137.3�6.5 139.6�7.4 23.3 0.0001 Weight (kg) 32.3�6.3 32.5�6.6 35.3�9.1 37.9�10.3 71.8 0.0001 BMI (kg/m

2) 17.0�2.4 17.3�2.6 18.6�3.6 19.2�3.9 78.6 0.0001 Body fat (%) 17.7�6.8 18.8�5.9 23.1�10.3 22.1�11.4 84.6 0.0001 Cholesterol (mmol/L) 4.73�0.89 4.38�0.66 4.25�0.75 4.47�0.82 54.7 0.001 Cholesterol conversion

(mg/dL)

183.0�34.6 169.4�25.5 164.3�29.1 172.7�31.9

NOTE: Number of subjects varies slightly for each variable because of some missing data. From Bingham, M. O., Harrell, J. S., Takada, H., Washino, K., Bradley, C., Berry, D., et al. (2009). Obesity and

cholesterol in Japanese, French, and U.S. children. Journal of Pediatric Nursing, 24(4), 317.

352 CHAPTER 11 Understanding Statistics in Research

Analysis of Covariance (ANCOVA) Analysis of covariance (ANCOVA) allows the researcher to examine the effect of a treatment apart

from the effect of one or more potentially confounding variables (see Chapter 5 for a discussion of

confounding variables). Potentially confounding variables that are generally of concern include

pretest scores, age, education, social class, and anxiety level. These variables would be confounding

if they were not measured and if their effects on study variables were not statistically removed by

performing regression analysis before performing ANOVA. This strategy removes the effect of dif-

ferences among groups that is caused by a confounding variable. Once this effect is removed, the

effect of the treatment can be examined more precisely. This technique sometimes is used as a

method of statistical control when it is not possible to design the study so that potentially con-

founding variables are controlled. However, control through careful planning of the design is more

effective than statistical control.

ANCOVA may be used in pretest–post-test designs in which differences occur in groups on the

pretest. For example, people who achieve low scores on a pretest tend to have lower scores on the

post-test than those whose pretest scores were higher, even if the treatment had a significant effect

on post-test scores. Conversely, if a person achieves a high pretest score, it is doubtful that the post-

test will indicate a strong change as a result of the treatment. ANCOVA maximizes the capability to

detect differences in such cases. This information was provided so that you might understand why

ANCOVA is conducted and are able to identify the confounding variables in a study that you are

critically appraising.

INTERPRETING RESEARCH OUTCOMES

To be useful, the evidence from data analysis must be carefully examined, organized, and given

meaning. Evaluating the entire research process, organizing the meaning of the results, and fore-

casting the usefulness of the findings are all part of interpreting research outcomes. Within the

process of interpretation of research outcomes are several intellectual activities that can be isolated

and explored, including examining findings, exploring the significance of the findings, identifying

limitations, forming conclusions, generalizing the findings, considering implications for nursing,

and suggesting further studies. This information usually is included in the final section of pub-

lished studies, which often is entitled “Discussion.”

Types of Results Interpretation of results from quasi-experimental and experimental studies is traditionally based

on decision theory, with five possible results: (1) significant results that agree with those predicted

by the researcher; (2) nonsignificant results; (3) significant results that are opposite from those

predicted by the researcher; (4) mixed results; and (5) unexpected results (Grove et al., 2013;

Shadish et al., 2002). In critically appraising a study, you need to identify which types of results

are presented in the study.

Significant and Predicted Results

Significant results agree with those predicted by the researcher and support the logical links

developedbytheresearcheramongtheframework,studyquestions,hypotheses,variables,andmeasure-

ment tools. In examining the results, however, you must consider the possibility of alternative explana-

tions for the positive findings. What other elements could possibly have led to the significant results?

Nonsignificant Results Nonsignificant (or inconclusive) results, often referred to as“negative” results, may bea true reflec-

tion of reality. In that case, the reasoning of the researcher or the theory used by the researcher

353CHAPTER 11 Understanding Statistics in Research

to develop the hypothesis is in error. If it is, the negative findings are an important addition to the

body of knowledge. However, the results also may stem from a type II error resulting from inappro-

priatemethodology,abiasedorsmallsample,threatstothedesignvalidity(seeChapter8),inadequate

measurement methods, weak statistical measures, or faulty analysis. In such instances, the reported

results couldintroduce faulty informationintothebodyofknowledge (Angell, 1989).Negative results

do not mean that no relationships exist among the variables. Negative results indicate only that

the study failed to find any. Nonsignificant results provide no evidence of the truth or falsity of the

hypothesis.

Significant and Unpredicted Results Significant and unpredicted results are the opposite of those predicted by the researcher and indi-

cate that flaws are present in the logic of the researcher and theory being tested. If the results are

valid, however, they constitute an important addition to the body of knowledge. For example, a

researcher may propose that social support and ego strength are positively correlated. If the rel-

evant study shows instead that high social support is correlated with low ego strength, the result is

the opposite of that predicted.

Mixed Results

Mixed results probably are the most common outcomes of studies. In this case, one variable may

uphold predicted characteristics, whereas another does not, or two dependent measures of the

same variable may show opposite results. These differences may be caused by methodology prob-

lems, such as differing reliability or sensitivity of two methods of measuring variables. The mixed

results may also indicate that existing theory should be modified.

Unexpected Results Unexpected results usually are relationships found between variables that were not hypothesized

and not predicted from the framework being used. Most researchers examine as many elements of

data as possible in addition to those directed by the questions. These findings can be useful in the

modification of existing theory and development of new theories and later studies. In addition,

unexpected or serendipitous results are important evidence for developing the implications of

the study. However, serendipitous results must be interpreted carefully, because the study was

not designed to examine these results.

Findings Results in a study are translated and interpreted to become study findings. Although much of the

process of developing findings from results occurs in the mind of the researcher, evidence of these

thought processes can be found in published research reports.

Exploring the Significance of Findings The significance of a study is associated with its importance in contributing to nursing’s body of

knowledge. The significance of study findings is not a dichotomous characteristic (significant or

nonsignificant) because studies contribute in varying degrees to the body of knowledge. Signifi-

cance of study findings may be associated with the amount of variance explained, degree of control

in the study design to eliminate unexplained variance, or ability to detect statistically significant

differences or relationships. To the extent possible at the time the study is reported, researchers are

expected to clarify the significance of the study findings.

The true importance of a particular study may not become apparent for years after publication.

Certain characteristics, however, are associated with the significance of studies—significant studies

354 CHAPTER 11 Understanding Statistics in Research

make an important difference in people’s lives; it is possible to generalize the findings far beyond

the study sample so that the findings have the potential of affecting large numbers of people. The

implications of significant studies go beyond concrete facts to abstractions and lead to the gener-

ation of theory or revisions of existing theory (Fawcett & Garity, 2009; Hoare & Hoe, 2013; Hoe &

Hoare, 2012). A very significant study has implications for one or more disciplines in addition to

nursing. The study is accepted by others in the discipline and frequently is referenced in the lit-

erature. Over time, the significance of a study is measured by the number of other studies that it

generates.

Clinical Importance of Findings The strongest findings of a study are those that have both statistical significance and clinical impor-

tance. Clinical importance is related to the practical relevance of the findings. There is no common

agreement in nursing about how to evaluate the clinical importance of a finding. The effect size,

however, can be used to determine clinical importance. For example, one group of patients may

have a body temperature 0.1� F higher than that of another group. Data analysis may indicate that the two groups are statistically significantly different, but the findings have no clinical importance.

The difference is not sufficiently important to warrant changing patient care. In many studies,

however, it is difficult to judge how much change would constitute clinical importance. In studies

testing the effectiveness of a treatment, clinical importance may be demonstrated by the propor-

tion of subjects who showed improvement or the extent to which subjects returned to normal

functioning, but how much improvement must subjects demonstrate for the findings to be con-

sidered clinically important? Questions also arise regarding who should judge clinical impor-

tance—patients and their families, clinicians, researchers, or society at large. At this point in

the development of nursing knowledge, clinical importance or relevance is ultimately a value judg-

ment (Fawcett & Garity, 2009; Hoare & Hoe, 2013; LeFort, 1993).

Limitations Limitations are restrictions or problems in a study that may decrease the generalizability of the

findings. Study limitations often include a combination of theoretical and methodological weak-

nesses. Theoretical weaknesses in a study might include a poorly developed or linked study frame-

work and unclear conceptual definitions of variables. The limited conceptual definitions of the

variables might decrease the operationalization or measurement of the study variables. Method-

ological limitations result from factors such as nonrepresentative samples, weak designs, single set-

ting, limited control over treatment (intervention) implementation, instruments with limited

reliability and validity, limited control over data collection, and improper use of statistical analyses.

These study limitations can limit the credibility of the findings and conclusions and restrict the

population to which the findings can be generalized. Most researchers identify the limitations

of their study in the discussion section of the research report and indicate how these limitations

might have affected the study findings and conclusions. Identifying study limitations is positive

but if these limitations are severe and multiple, the credibility of the findings need to be

questioned.

Conclusions Conclusions are a synthesis of the findings. In forming conclusions, the researcher uses logical

reasoning, creates a meaningful whole from pieces of information obtained through data analysis

and findings from previous studies, and considers alternative explanations of the data. One of the

risks in developing conclusions is going beyond the study results or forming conclusions that are

not warranted by the findings.

355CHAPTER 11 Understanding Statistics in Research

Generalizing the Findings Generalization extends the implications of the findings from the sample studied to a larger pop-

ulation (see earlier, “Inference and Generalization”). For example, if the study was conducted on

patients with osteoarthritis, it may be possible to generalize the findings from the sample to the

larger target population of patients with osteoarthritis or to those with other types of arthritis. Kim

and colleagues (2012) were very cautious in making generalizations related to their study findings

about the effectiveness of the aquarobic exercise program. They indicated that their study partic-

ipants were recruited from only one public health center and were most likely not representative of

all patients with osteoarthritis. They recommended conducting studies with larger random sam-

ples from different settings before generalizing the study findings.

Implications for Nursing Implications for nursing are the meanings of conclusions from scientific research for the body of

nursing knowledge, theory, and practice (Chinn & Kramer, 2011). Implications are based on but

are more specific than conclusions; they provide specific suggestions for implementing the find-

ings in nursing. For example, a researcher may suggest how nursing practice should be modified. If

a study indicates that a specific solution is effective in decreasing pressure ulcers in hospitalized

older patients, the implications will state how the care of older patients needs to be modified

to prevent pressure ulcers. Interventions with extensive research support provide the basis for

developing EBP guidelines and ensuring quality, safe nursing practice (see Chapter 13).

Recommendations for Further Studies In every study, the researcher gains knowledge and experience that can be used to design a better

study next time. Therefore the researcher often will make suggestions for future studies that emerge

logically from the present study. Recommendations for further study may include replications or

repeating the design with a different or larger sample, using different measurement methods, or

testing a new intervention. Recommendations may also include the formation of hypotheses to

further test the framework in use. This section provides other researchers with ideas for future

studies needed to develop the knowledge needed for EBP (Brown, 2014; Melnyk & Fineout-

Overholt, 2011).

? CRITICAL APPRAISAL GUIDELINES Research Outcomes

When critically appraising the research outcomes of a study, you need to examine the discussion section of the

research report and address the following questions:

1. What are the study findings, and were they appropriate considering the statistical results?

2. Were the study findings linked to previous research findings?

3. Were the findings clinically important?

4. What were the study limitations and how might they have affected the study conclusions?

5. Were the conclusions appropriate based on the study results, findings, and limitations?

6. To what population(s) did the researchers generalize the study findings? Were the generalizations

appropriate?

7. What implications for nursing knowledge, theory, and practice were identified?

8. Were the implications for nursing practice appropriate based on the study findings and conclusions?

9. Did the researchers make recommendations for further studies? Were these recommendations based on the

study results, findings, limitations, and conclusions?

356 CHAPTER 11 Understanding Statistics in Research

RESEARCH EXAMPLE

Research Outcomes

Research Study Excerpt The research outcomes from the discussion section of the study by Lee, Faucett, Gillen, Krause, and Landry (2013)

is presented as an example and critically appraised. The purpose of this study was to investigate how “critical

care nurses perceived the risk of musculoskeletal [MSK] injury from work and to identify factors associated with

their risk perception” (Lee et al., 2013, p. 36). The study sample included 1000 critical care nurses who were

randomly selected from the 2005 membership list of the American Association of Critical Care Nurses (AACN).

This was a significant study, because nursing is an occupation with a high risk of MSK injury, and how nurses’

perceive their risks for injury may be important in preventing work-related injuries. The following study excerpt

includes information from the discussion section of this study; the key elements of this section are identified

in brackets.

“Critical care nurses, overall, were concerned about ergonomic risks in their work environment. Eighty-three

percent of study participants reported that they were more likely than not to experience an MSK injury within

1 year—a relatively short time frame. Particularly, critical care nurses were well aware of risks from manual

patient handling, and they felt safer when performing tasks using a lifting device. However, more than half

of the participants did not have lifting devices on their units.. . . Similar findings were shown in a survey by

American Nurses Association.” [findings compared to previous research].. . . (Lee et al., 2013, p. 40)

This study identified five significant predictors of risk perception for MSK injury among critical

care nurses. Higher overall risk perceptions were associated significantly with greater job strain, higher

physical workload index, more frequent patient handling, lack of availability of lift devices or lift teams,

and higher MSK symptom index. Of these five variables, job strain and availability of lift devices or lift teams

were significant for both risk perception to self and risk perception to others [statistically significant

findings].. . .

Availability of lift devices or lift teams was associated also with all three risk perception measures. Risk

perception of MSK injury was lower among nurses who had a lift device or a lift team than those who had

neither [clinical importance of findings]. Indeed, actual reduction of risk of MSK injury by the use of lift devices

or lift teams has been shown in many studies [findings linked to previous research].. . .The finding of a sig-

nificant association between symptom experience and risk perception is meaningful because the ultimate

goal of the study is to prevent MSK injury. Determining how risk perception influences injury prevention

should be of interest to occupational health researchers, and further research is needed [recommendations

for further research].. . .In addition to the limitations noted above, the representativeness of the sample

across critical care nurses may have been limited by the response rates [limitation]. Furthermore, findings

about critical care nurses may not generalize to nurses in different clinical settings [generalization of findings].

Also, the use of a single sample survey method may introduce bias related to social desirability or negative

affectivity [limitation].”

Conclusions

“In conclusion, critical care nurses’ perceptions about risk from their work environment were elucidated and

their greater perception of risk for MSK injury was found to be associated with greater job strain, greater

physical workload, more frequent patient-handling tasks, the lack of lifting devices or a lifting team, and expe-

rience of more severe MSK symptoms [conclusions]. This study provides a framework to assist occupational

health professionals and nurse managers to better understand nurses’ perceptions about their personal

risks.. . . Occupational health professionals, nurse managers, and nursing organizations should make con-

certed efforts to ensure the safety of nurses by providing effective preventive measures. Improving the phys-

ical and psychosocial work environment may make nursing jobs safer, reduce the risk of MSK injury, and

improve nurses’ perceptions of job safety. Ultimately, these efforts would contribute to enhancing safety

in nursing settings and to maintaining a healthy nursing workforce [implications for nursing]. Future research

is needed to determine the role of risk perception in preventing a MSK injury.” (Lee et al., 2013, pp. 42-43) Continued

357CHAPTER 11 Understanding Statistics in Research

K E Y C O N C E P T S

• In critically appraising a quantitative study, you need to (1) identify the statistical procedures

used, (2) judge whether these statistical procedures were appropriate for the hypotheses, ques-

tions, or objectives of the study and the data available for analysis, (3) judge whether the

authors’ interpretation of the results is appropriate, and (4) evaluate the clinical importance

of the findings.

• Quantitative data analysis has several stages: (1) management of missing data; (2) description of

the study sample; (3) reliability of measurement methods; (4) conduct of exploratory analysis of

the data; and (5) conduct of inferential analyses guided by the hypotheses, questions, or

objectives.

• Understanding the statistical theories and relevant concepts will assist you in appraising quan-

titative studies.

• Probability theory is used to explain a relationship, the probability of an event occurring in a

given situation, or the probability of accurately predicting an event.

• Decision theory assumes that all the groups in a study used to test a particular hypothesis are

components of the same population in relation to the study variables.

• A type I error occurs when the null hypothesis is rejected when it is true. The researchers con-

clude that significant results exist in a study, when in reality they do not. The risk of a type I error

is indicated by the level of significance (a). • A type II error occurs when the null hypothesis is accepted when it is false. The researchers con-

clude that the study results are nonsignificant when the results are significant. Type II errors

often occur because of flaws in the research methods, and their risk can be examined using

power analysis.

RESEARCH EXAMPLE—cont’d

Critical Appraisal Lee and associates (2013) discussed their significant and nonsignificant findings, which were consistent with their

study results. The findings were also compared with the findings of previous studies, and possible reasons were

provided for nonsignificant findings. However, the researchers did not determine the power achieved with the non-

significant results. The findings are clinically important because of the increased understanding provided regarding

nurses’ perceptions of their risk for MSK injuries.

Lee and co-workers (2013) clearly identified their study limitations, which limited the generalization of the find-

ings. The findings were generalized to the accessible population of critical care nurses sampled but were limited by

the response rate to the survey from being generalized to the target population of all critical care nurses in the AACN.

In addition, the researchers indicated the findings could not be generalized to nurses in other clinical settings.

Lee and colleagues (2013) provided specific conclusions for their study at the end of their research report and

clearly labeled the section “Conclusions.” The conclusions were consistent with their study results and findings.

The researchers’ conclusions provided a basis for the implications for nursing practice and recommendations

for further research. The implications for practice were clearly expressed and involved enhancing the safety of nurs-

ing settings to maintain a healthy nursing workforce. The researchers made recommendations for areas of further

research but they might have provided more specific ideas for future studies.

In summary, Lee and associates (2013) provided a comprehensive discussion section that addressed the essential

findings, limitations, conclusions, generalizations, implications for nursing, and recommendations for further

research. The QSEN (2013) implications are that nurses need a safe work environment to minimize their risk of

MSK injury.

358 CHAPTER 11 Understanding Statistics in Research

• Descriptive or summary statistics covered in this text include frequency distributions, percent-

ages, measures of central tendency, measures of dispersion, and scatterplot.

• Statistical analyses conducted to examine relationships that are covered in this text include

Pearson product-moment correlation and factor analysis.

• Regression analysis is conducted to predict the value of one dependent variable using one or

more independent variables.

• Statistical analyses conducted to examine group differences and determine causality included in

this text are the chi-square test, t-test, analysis of variance (ANOVA), and analysis of covariance

(ANCOVA).

• Interpretation of results from quasi-experimental and experimental studies is traditionally

based on decision theory, with five possible results: (1) significant results predicted by the

researcher; (2) nonsignificant results; (3) significant results that are opposite from those pre-

dicted by the researcher; (4) mixed results; and (5) unexpected results.

• Research outcomes usually include findings, limitations, conclusions, generalization of find-

ings, implications for nursing, and recommendations for further studies.

• In critically appraising a study, you will need to evaluate the appropriateness and completeness

of the researchers’ results and discussion sections.

REFERENCES

American Psychological Association (APA). (2010).

Publication manual of the American Psychological

Association (6th ed.). Washington, DC: Author.

Angell, M. (1989). Negative studies. New England Journal

of Medicine, 321(7), 464–466.

Bingham, M. O., Harrell, J. S., Takada, H., Washino, K.,

Bradley, C., Berry, D., et al. (2009). Obesity and

cholesterol in Japanese, French, and U.S. children.

Journal of Pediatric Nursing, 24(4), 314–322.

Brown, S. J. (2014). Evidence-based nursing: The research-

practiceconnection(3rded.).Sudbury,MA:Jones&Bartlett.

Chinn, P. L., & Kramer, M. K. (2011). Integrated theory and

knowledge development in nursing (8th ed.). St. Louis:

Elsevier Mosby.

Cohen, J. (1988). Statistical power analysis for the behavioral

sciences (2nd ed.). New York: Academic Press.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh: Churchill

Livingstone Elsevier.

Dickson, V. V., Howe, A., Deal, J., & McCarthy, M. M.

(2012). The relationship of work, self-care, and quality

of life in a sample of older working adults with

cardiovascular disease. Heart & Lung, 41(1), 5–14.

Doran, D. M. (2011). Nursing outcomes: The state of the

science (2nd ed.). Burlington, MA: Jones & Bartlett

Learning.

Fawcett, J., & Garity, J. (2009). Evaluating research

for evidence-based nursing practice. Philadelphia:

F. A. Davis.

Grove, S. K. (2007). Statistics for health care research: A

practical workbook. St. Louis: Elsevier Saunders.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice

of nursing research: Appraisal, synthesis, and

generation of evidence (7th ed.). St. Louis: Elsevier

Saunders.

Hoare, Z., & Hoe, J. (2013). Understanding quantitative

research: Part 2. Nursing Standard (Royal College of

Nursing [Great Britain]), 27(18), 48–55.

Hoe, J., & Hoare, Z. (2012). Understanding quantitative

research: Part 1. Nursing Standard (Royal College of

Nursing [Great Britain]), 27(15–17), 52–57.

Kim, I., Chung, S., Park, Y., & Kang, H. (2012). The

effectiveness of an aquarobic exercise program for

patients with osteoarthritis. Applied Nursing Research,

25(3), 181–189.

Lavoie-Tremblay, M., Wright, D., Desforges, N.,

Gelinas, C., Marchionni, C., & Drevniok, U. (2008).

Creating a healthy workplace for new-generation

nurses. Journal of Nursing Scholarship, 40(3), 290–297.

Lee, S., Faucett, J., Gillen, M., Krause, N., & Landry, L.

(2013). Risk of perception of musculoskeletal injury

among critical care nurses. Nursing Research, 62(1),

36–44.

LeFort, S. M. (1993). The statistical versus clinical

significance debate. Image—The Journal of Nursing

Scholarship, 25(1), 57–62.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-

based practice in nursing & healthcare: A guide to best

359CHAPTER 11 Understanding Statistics in Research

practice (2nd ed.). Philadelphia: Lippincott, Williams,

& Wilkins.

Plichta, S. B., & Kelvin, E. (2013). Munro’s statistical

methods for health care research (6th ed.). Philadelphia:

Lippincott Williams & Wilkins.

Quality and Safety Education for Nurses (QSEN), (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved February 11, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002).

Experimental and quasi-experimental designs for

generalized causal inference. Chicago: Rand McNally.

Slakter, M. H., Wu, Y. B., & Suzaki-Slakter, N. S. (1991). *, **,

and ***: Statistical nonsense at the .00000 level. Nursing

Research, 40(4), 248–249.

Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010).

Measurement in nursing and health research (4th ed.).

New York: Springer.

360 CHAPTER 11 Understanding Statistics in Research

C H A P T E R

12 Critical Appraisal of Quantitative and

Qualitative Research for Nursing Practice

C H A P T E R OV E R V I E W

When Are Critical Appraisals of Studies

Implemented in Nursing? 362

Students’ Critical Appraisal of Studies, 363

Critical Appraisal of Studies by Practicing

Nurses, Nurse Educators, and

Researchers, 363

Critical Appraisal of Research Following

Presentation and Publication, 364

Critical Appraisal of Research for Presentation

and Publication, 364

Critical Appraisal of Research Proposals, 364

What Are the Key Principles for Conducting

Intellectual Critical Appraisals of Quantitative

and Qualitative Studies? 365

Understanding the Quantitative Research

Critical Appraisal Process, 366

Step 1: Identifying the Steps of the Research

Process in Studies, 366

Step 2: Determining the Strengths and

Weaknesses in Studies, 370

Step 3: Evaluating the Credibility and Meaning of

Study Findings, 374

Example of a Critical Appraisal of a Quantitative

Study, 375

Understanding the Qualitative Research Critical

Appraisal Process, 389

Step 1: Identifying the Components of the

Qualitative Research Process in Studies, 389

Step 2: Determining the Strengths and

Weaknesses in Studies, 391

Step 3: Evaluating the Trustworthiness and

Meaning of Study Finding, 394

Example of a Critical Appraisal of a Qualitative

Study, 394

Key Concepts, 410

References, 411

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Describe when intellectual critical appraisals of

studies are conducted in nursing.

2. Implement key principles in critically appraising

quantitative and qualitative studies.

3. Describe the three steps for critically appraising

a study: (1) identifying the steps of the research

process in the study; (2) determining study

strengths and weaknesses; and (3) evaluating

the credibility and meaning of the study

findings.

4. Conduct a critical appraisal of a quantitative

research report.

5. Conduct a critical appraisal of a qualitative

research report.

361

K E Y T E R M S

Confirmability, p. 392

Credibility, p. 392

Critical appraisal, p. 362

Critical appraisal of qualitative

studies, p. 389

Critical appraisal of

quantitative studies, p. 362

Dependability, p. 392

Determining strengths and

weaknesses in the studies,

p. 370

Evaluating the credibility and

meaning of study findings,

p. 374

Identifying the steps of the

research process in studies,

p. 366

Intellectual critical appraisal of

a study, p. 365

Qualitative research critical

appraisal process, p. 389

Quantitative research critical

appraisal process, p. 366

Referred journals, p. 364

Transferable, p. 392

Trustworthiness, p. 392

The nursing profession continually strives for evidence-based practice (EBP), which includes crit-

ically appraising studies, synthesizing the findings, applying the scientific evidence in practice, and

determining the practice outcomes (Brown, 2014; Doran, 2011; Melnyk & Fineout-Overholt,

2011). Critically appraising studies is an essential step toward basing your practice on current

research findings. The term critical appraisal or critique is an examination of the quality of a study

to determine the credibility and meaning of the findings for nursing. Critique is often associated

with criticize, a word that is frequently viewed as negative. In the arts and sciences, however, cri-

tique is associated with critical thinking and evaluation—tasks requiring carefully developed intel-

lectual skills. This type of critique is referred to as an intellectual critical appraisal. An intellectual

critical appraisal is directed at the element that is created, such as a study, rather than at the creator,

and involves the evaluation of the quality of that element. For example, it is possible to conduct an

intellectual critical appraisal of a work of art, an essay, and a study.

The idea of the intellectual critical appraisal of research was introduced earlier in this text and has

been woven throughout the chapters. As each step of the research process was introduced, guide-

lines were provided to direct the critical appraisal of that aspect of a research report. This chapter

summarizes and builds on previous critical appraisal content and provides direction for conducting

critical appraisals of quantitative and qualitative studies. The background provided by this chapter

serves as a foundation for the critical appraisal of research syntheses (systematic reviews, meta-

analyses, meta-syntheses, and mixed-methods systematic reviews) presented in Chapter 13.

This chapter discusses the implementation of critical appraisals in nursing by students, prac-

ticing nurses, nurse educators, and researchers. The key principles for implementing intellectual

critical appraisals of quantitative and qualitative studies are described to provide an overview of the

critical appraisal process. The steps for critical appraisal of quantitative studies, focused on rigor,

design validity, quality, and meaning of findings, are detailed, and an example of a critical appraisal

of a published quantitative study is provided. The chapter concludes with the critical appraisal

process for qualitative studies and an example of a critical appraisal of a qualitative study.

WHEN ARE CRITICAL APPRAISALS OF STUDIES IMPLEMENTED IN NURSING?

In general, studies are critically appraised to broaden understanding, summarize knowledge for

practice, and provide a knowledge base for future research. Studies are critically appraised for class

projects and to determine the research evidence ready for use in practice. In addition, critical

appraisals are often conducted after verbal presentations of studies, after a published research

report, for selection of abstracts when studies are presented at conferences, for article selection

for publication, and for evaluation of research proposals for implementation or funding. Therefore

362 CHAPTER 12 Critical Appraisal for Nursing Practice

nursing students, practicing nurses, nurse educators, and nurse researchers are all involved in the

critical appraisal of studies.

Students’ Critical Appraisal of Studies One aspect of learning the research process is being able to read and comprehend published

research reports. However, conducting a critical appraisal of a study is not a basic skill, and the

content presented in previous chapters is essential for implementing this process. Students usually

acquire basic knowledge of the research process and critical appraisal process in their baccalaureate

program. More advanced analysis skills are often taught at the master’s and doctoral levels. Per-

forming a critical appraisal of a study involves the following three steps, which are detailed in this

chapter: (1) identifying the steps or elements of the study; (2) determining the study strengths and

limitations; and (3) evaluating the credibility and meaning of the study findings. By critically

appraising studies, you will expand your analysis skills, strengthen your knowledge base, and

increase your use of research evidence in practice. Striving for EBP is one of the competencies iden-

tified for associate degree and baccalaureate degree (prelicensure) students by the Quality and

Safety Education for Nurses (QSEN, 2013) project, and EBP requires critical appraisal and synthe-

sis of study findings for practice (Sherwood & Barnsteiner, 2012). Therefore critical appraisal of

studies is an important part of your education and your practice as a nurse.

Critical Appraisal of Studies by Practicing Nurses, Nurse Educators, and Researchers Practicing nurses need to appraise studies critically so that their practice is based on current research

evidence and not on tradition or trial and error (Brown, 2014; Craig & Smyth, 2012). Nursing actions

need to be updated in response to current evidence that is generated through research and theory

development. It is important for practicing nurses to design methods for remaining current in their

practice areas.Reading researchjournalsand posting ore-mailingcurrentstudiesatwork canincrease

nurses’ awareness of study findings but are not sufficient for critical appraisal to occur. Nurses need to

question the qualityof the studies, credibilityof the findings, and meaning of the findings for practice.

For example, nurses might form a research journal club in which studies are presented and critically

appraised by members of the group (Gloeckner & Robinson, 2010).

Skills in critical appraisal of research enable practicing nurses to synthesize the most credible,

significant, and appropriate evidence for use in their practice. EBP is essential in agencies that are

seeking or maintaining Magnet status. The Magnet Recognition Program was developed by the

American Nurses Credentialing Center (ANCC, 2013) to “recognize healthcare organizations

for quality patient care, nursing excellence, and innovations in professional nursing,” which

requires implementing the most current research evidence in practice (see http://www.

nursecredentialing.org/Magnet/ProgramOverview.aspx).

Your faculty members critically appraise research to expand their clinical knowledge base and to

develop and refine the nursing educational process. The careful analysis of current nursing studies

provides a basis for updating curriculum content for use in clinical and classroom settings. Faculty

serve as role models for their students by examining new studies, evaluating the information obtained

from research, and indicating which research evidence to use in practice. For example, nursing

instructors might critically appraise and present the most current evidence about caring for people

with hypertension in class and role-model the management of patients with hypertension in practice.

Nurse researchers critically appraise previous research to plan and implement their next study.

Many researchers have a program of research in a selected area, and they update their knowledge

base by critically appraising new studies in this area. For example, selected nurse researchers have a

363CHAPTER 12 Critical Appraisal for Nursing Practice

program of research to identify effective interventions for assisting patients in managing their

hypertension and reducing their cardiovascular risk factors.

Critical Appraisal of Research Following Presentation and Publication When nurses attend research conferences, they note that critical appraisals and questions often

follow presentations of studies. These critical appraisals assist researchers in identifying the

strengths and weaknesses of their studies and generating ideas for further research. Participants

listening to study critiques might gain insight into the conduct of research. In addition, experienc-

ing the critical appraisal process can increase the conference participants’ ability to evaluate studies

and judge the usefulness of the research evidence for practice.

Critical appraisals have been published following some studies in research journals. For example,

the research journals Scholarly Inquiry for Nursing Practice: An International Journal and Western

Journal of Nursing Research include commentaries after the research articles. In these commentaries,

other researchers critically appraise the authors’ studies, and the authors have a chance to respond

to these comments. Published research critical appraisals often increase the reader’s understanding

of the study and the quality of the study findings (American Psychological Association [APA],

2010). A more informal critical appraisal of a published study might appear in a letter to the editor.

Readers have the opportunity to comment on the strengths and weaknesses of published studies by

writing to the journal editor.

Critical Appraisal of Research for Presentation and Publication Planners of professional conferences often invite researchers to submit an abstract of a study they are

conducting or have completed for potential presentation at the conference. The amount of informa-

tionavailableisusuallylimited,becausemanyabstractsarerestrictedto100to250words.Nevertheless,

reviewers must select the best-designed studies with the most significant outcomes for presentation at

nursingconferences. Thisprocess requires anexperienced researcher who needs fewcues to determine

the quality of a study. Critical appraisal of an abstract usually addresses the following criteria: (1)

appropriateness of the study for the conference program; (2) completeness of the research project;

(3) overall quality of the study problem, purpose, methodology, and results; (4) contribution of

the study to nursing’s knowledge base; (5) contribution of the study to nursing theory; (6) originality

of the work (not previously published); (7) implication of the study findings for practice; and (8) clar-

ity, conciseness, and completeness of the abstract (APA, 2010; Grove, Burns, & Gray, 2013).

Some nurse researchers serve as peer reviewers for professional journals to evaluate the quality of

research papers submitted for publication. The role of these scientists is to ensure that the studies

accepted for publication are well designed and contributeto the bodyof knowledge. Journals that have

their articles critically appraised by expert peer reviews are called peer-reviewed journals or referred

journals (Pyrczak, 2008). The reviewers’ comments or summaries of their comments are sent to the

researchers to direct their revision of the manuscripts for publication. Referred journals usually have

studies and articles of higher quality and provide excellent studies for your review for practice.

Critical Appraisal of Research Proposals Critical appraisals of research proposals are conducted to approve student research projects, permit

data collection in an institution, and select the best studies for funding by local, state, national, and

international organizations and agencies. You might be involved in a proposal review if you are

participating in collecting data as part of a class project or studies done in your clinical agency. More

details on proposal development and approval can be found in Grove et al. (2013, Chapter 28).

Research proposals are reviewed for funding from selected government agencies and corpora-

tions. Private corporations develop their own format for reviewing and funding research projects

364 CHAPTER 12 Critical Appraisal for Nursing Practice

(Grove et al., 2013). The peer review process in federal funding agencies involves an extremely

complex critical appraisal. Nurses are involved in this level of research review through national

funding agencies, such as the National Institute of Nursing Research (NINR, 2013) and the Agency

for Healthcare Research and Quality (AHRQ, 2013).

WHAT ARE THE KEY PRINCIPLES FOR CONDUCTING INTELLECTUAL CRITICAL APPRAISALS OF QUANTITATIVE AND QUALITATIVE STUDIES?

An intellectual critical appraisal of a study involves a careful and complete examination of a study

to judge its strengths, weaknesses, credibility, meaning, and significance for practice. A high-quality

study focuses on a significant problem, demonstrates sound methodology, produces credible find-

ings, indicates implications for practice, and provides a basis for additional studies (Grove et al.,

2013; Hoare & Hoe, 2013; Hoe & Hoare, 2012). Ultimately, the findings from several quality studies

can be synthesized to provide empirical evidence for use in practice (O’Mathuna, Fineout-

Overholt, & Johnston, 2011).

The major focus of this chapter is conducting critical appraisals of quantitative and qualitative

studies. These critical appraisals involve implementing some key principles or guidelines, outlined

in Box 12-1. These guidelines stress the importance of examining the expertise of the authors,

reviewing the entire study, addressing the study’s strengths and weaknesses, and evaluating the cred-

ibility of the study findings (Fawcett & Garity, 2009; Hoare & Hoe, 2013; Hoe & Hoare, 2012;

BOX 12-1 KEY PRINCIPLES FOR CRITICALLY APPRAISING QUANTITATIVE AND QUALITATIVE STUDIES

1. Read and critically appraise the entire study. A research critical appraisal involves examining the quality

of all aspects of the research report.

2. Examine the organization and presentation of the research report. A well-prepared report is complete,

concise, clearly presented, and logically organized. It does not include excessive jargon that is difficult for

you to read. The references need to be current, complete, and presented in a consistent format.

3. Examine the significance of the problem studied for nursing practice. The focus of nursing studies

needs to be on significant practice problems if a sound knowledge base is to be developed for

evidence-based nursing practice.

4. Indicate the type of study conducted and identify the steps or elements of the study. This might

be done as an initial critical appraisal of a study; it indicates your knowledge of the different types of

quantitative and qualitative studies and the steps or elements included in these studies.

5. Identify the strengths and weaknesses of a study. All studies have strengths and weaknesses, so atten-

tion must be given to all aspects of the study.

6. Be objective and realistic in identifying the study’s strengths and weaknesses. Be balanced in your

critical appraisal of a study. Try not to be overly critical in identifying a study’s weaknesses or overly flattering

in identifying the strengths.

7. Provide specific examples of the strengths and weaknesses of a study. Examples provide evidence for

your critical appraisal of the strengths and weaknesses of a study.

8. Provide a rationale for your critical appraisal comments. Include justifications for your critical appraisal,

and document your ideas with sources from the current literature. This strengthens the quality of your

critical appraisal and documents the use of critical thinking skills.

9. Evaluate the quality of the study. Describe the credibility of the findings, consistency of the findings with

those from other studies, and quality of the study conclusions.

10. Discuss the usefulness of the findings for practice. The findings from the study need to be linked to the

findings of previous studies and examined for use in clinical practice.

365CHAPTER 12 Critical Appraisal for Nursing Practice

Munhall, 2012). All studies have weaknesses or flaws; if every flawed study were discarded, no sci-

entific evidence would be available for use in practice. In fact, science itself is flawed. Science does

not completely or perfectly describe, explain, predict, or control reality. However, improved under-

standing and increased ability to predict and controlphenomena depend on recognizing the flaws in

studies and science. Additional studies can then be planned to minimize the weaknesses of earlier

studies. You also need to recognize a study’s strengths to determine the quality of a study and cred-

ibility of its findings. When identifying a study’s strengths and weaknesses, you need to provide

examples and rationale for your judgments that are documented with current literature.

Critical appraisal of quantitative and qualitative studies involves a final evaluation to determine the

credibility of the study findings and any implications for practice and further research (see Box 12-1).

Adding together the strong points from multiplestudies slowly builds a solid base of evidence for prac-

tice. These guidelines provide a basis for the critical appraisal process for quantitative research

discussed in the next section and the critical appraisal process for qualitative research (see later).

UNDERSTANDING THE QUANTITATIVE RESEARCH CRITICAL APPRAISAL PROCESS

The quantitative research critical appraisal process includes three steps: (1) identifying the steps

of the research process in studies; (2) determining study strengths and weaknesses; and (3)

evaluating the credibility and meaning of study findings. These steps occur in sequence, vary in

depth, and presume accomplishment of the preceding steps. However, an individual with critical

appraisal experience frequently performs two or three steps of this process simultaneously.

This section includes the three steps of the quantitative research critical appraisal process and

provides relevant questions for each step. These questions have been selected as a means for stim-

ulating the logical reasoning and analysis necessary for conducting a critical appraisal of a study.

Those experienced in the critical appraisal process often formulate additional questions as part of

their reasoning processes. We will identify the steps of the research process separately because those

new to critical appraisal start with this step. The questions for determining the study strengths and

weaknesses are covered together because this process occurs simultaneously in the mind of the

person conducting the critical appraisal. Evaluation is covered separately because of the increased

expertise needed to perform this step.

Step 1: Identifying the Steps of the Research Process in Studies Initial attempts to comprehend research articles are often frustrating because the terminology and

stylized manner of the report are unfamiliar. Identifying the steps of the research process in a

quantitative study is the first step in critical appraisal. It involves understanding the terms and

concepts in the report, as well as identifying study elements and grasping the nature, significance,

and meaning of these elements. The following guidelines will direct you in identifying a study’s

elements or steps.

Guidelines for Identifying the Steps of the Research Process in Studies The first step involves reviewing the abstract and reading the study from beginning to end. As you

read, think about the following questions regarding the presentation of the study:

• Was the study title clear?

• Was the abstract clearly presented?

• Was the writing style of the report clear and concise?

• Were relevant terms defined? You might underline the terms you do not understand and deter-

mine their meaning from the glossary at the end of this text.

366 CHAPTER 12 Critical Appraisal for Nursing Practice

• Were the following parts of the research report plainly identified (APA, 2010)?

• Introduction section, with the problem, purpose, literature review, framework, study vari-

ables, and objectives, questions, or hypotheses

• Methods section, with the design, sample, intervention (if applicable), measurement

methods, and data collection or procedures

• Results section, with the specific results presented in tables, figures, and narrative

• Discussion section, with the findings, conclusions, limitations, generalizations, implications for

practice, and suggestions for future research (Fawcett & Garity, 2009; Grove et al., 2013)

We recommend reading the research article a second time and highlighting or underlining the

steps of the quantitative research process that were identified previously. An overview of these steps

is presented in Chapter 2. After reading and comprehending the content of the study, you are ready

to write your initial critical appraisal of the study. To write a critical appraisal identifying the study

steps, you need to identify each step of the research process concisely and respond briefly to the

following guidelines and questions.

1. Introduction

a. Describe the qualifications of the authors to conduct the study (e.g., research expertise con-

ducting previous studies, clinical experience indicated by job, national certification, and

years in practice, and educational preparation that includes conducting research [PhD]).

b. Discuss the clarity of the article title. Is the title clearly focused and does it include key study

variables and population? Does the title indicate the type of study conducted—descriptive,

correlational, quasi-experimental, or experimental—and the variables (Fawcett & Garity,

2009; Hoe & Hoare, 2012; Shadish, Cook, & Campbell, 2002)?

c. Discuss the quality of the abstract (includes purpose, highlights design, sample, and inter-

vention [if applicable], and presents key results; APA, 2010).

2. State the problem.

a. Significance of the problem

b. Background of the problem

c. Problem statement

3. State the purpose.

4. Examine the literature review.

a. Are relevant previous studies and theories described?

b. Are the references current (number and percentage of sources in the last 5 and 10 years)?

c. Are the studies described, critically appraised, and synthesized (Brown, 2014; Fawcett &

Garity, 2009)? Are the studies from referred journals?

d. Is a summary provided of the current knowledge (what is known and not known) about the

research problem?

5. Examine the study framework or theoretical perspective.

a. Is the framework explicitly expressed, or must you extract the framework from statements

in the introduction or literature review of the study?

b. Is the framework based on tentative, substantive, or scientific theory? Provide a rationale

for your answer.

c. Does the framework identify, define, and describe the relationships among the concepts of

interest? Provide examples of this.

d. Is a map of the framework provided for clarity? If a map is not presented, develop a map

that represents the study’s framework and describe the map.

e. Link the study variables to the relevant concepts in the map.

f. How is the framework related to nursing’s body of knowledge (Alligood, 2010; Fawcett &

Garity, 2009; Smith & Liehr, 2008)?

367CHAPTER 12 Critical Appraisal for Nursing Practice

6. List any research objectives, questions, or hypotheses.

7. Identify and define (conceptually and operationally) the study variables or concepts that were

identified in the objectives, questions, or hypotheses. If objectives, questions, or hypotheses are

not stated, identify and define the variables in the study purpose and results section of the

study. If conceptual definitions are not found, identify possible definitions for each major

study variable. Indicate which of the following types of variables were included in the study.

A study usually includes independent and dependent variables or research variables, but not all

three types of variables.

a. Independent variables: Identify and define conceptually and operationally.

b. Dependent variables: Identify and define conceptually and operationally.

c. Research variables or concepts: Identify and define conceptually and operationally.

8. Identify attribute or demographic variables and other relevant terms.

9. Identify the research design.

a. Identify the specific design of the study (see Chapter 8).

b. Does the study include a treatment or intervention? If so, is the treatment clearly described

with a protocol and consistently implemented?

c. If the study has more than one group, how were subjects assigned to groups?

d. Are extraneous variables identified and controlled? Extraneous variables are usually dis-

cussed as a part of quasi-experimental and experimental studies.

e. Were pilot study findings used to design this study? If yes, briefly discuss the pilot and the

changes made in this study based on the pilot (Grove et al., 2013; Shadish et al., 2002).

10. Describe the sample and setting.

a. Identify inclusion and exclusion sample or eligibility criteria.

b. Identify the specific type of probability or nonprobability sampling method that was used

to obtain the sample. Did the researchers identify the sampling frame for the study?

c. Identify the sample size. Discuss the refusal number and percentage, and include the ratio-

nale for refusal if presented in the article. Discuss the power analysis if this process was used

to determine sample size (Aberson, 2010).

d. Identify the sample attrition (number and percentage) for the study.

e. Identify the characteristics of the sample.

f. Discuss the institutional review board (IRB) approval. Describe the informed consent pro-

cess used in the study.

g. Identify the study setting and indicate whether it is appropriate for the study purpose.

11. Identify and describe each measurement strategy used in the study. The following table includes

the critical information about two measurement methods, the Beck Likert scale and a physio-

logical instrument to measure blood pressure. Completing this table will allow you to cover

essential measurement content for a study (Waltz, Strickland, & Lenz, 2010).

a. Identify each study variable that was measured.

b. Identify the name and author of each measurement strategy.

c. Identify the type of each measurement strategy (e.g., Likert scale, visual analog scale, phys-

iological measure, or existing database).

d. Identify the level of measurement (nominal, ordinal, interval, or ratio) achieved by each

measurement method used in the study (Grove, 2007).

e. Describe the reliability of each scale for previous studies and this study. Identify the precision

of each physiological measure (Bialocerkowski, Klupp, & Bragge, 2010; DeVon et al., 2007).

f. Identify the validity of each scale and the accuracy of physiological measures (DeVon et al.,

2007; Ryan-Wenger, 2010).

368 CHAPTER 12 Critical Appraisal for Nursing Practice

Variable

Measured

Name of

Measurement

Method

(Author)

Type of

Measurement

Method

Level of

Measurement Reliability or Precision Validity or Accuracy

Depression Beck

Depression

Inventory

(Beck)

Likert scale Interval Cronbach alphas of 0.82-

0.92 from previous

studies and 0.84 for this

study; reading level at

6th grade.

Construct validity—content validity

from concept analysis, literature

review, and reviews of experts;

convergent validity of 0.04 with Zung

Depression Scale; predictive validity

of patients’ future depression

episodes; successive use validity

with the conduct of previous studies

and this study.

Blood

pressure

Omron blood

pressure (BP)

equipment

(equipment

manufacturer)

Physiological

measurement

method

Ratio Test-retest values of BPs

in previous studies; BP

equipment new and

recalibrated every 50

BP readings in this

study; average three

BP readings to

determine BP.

Documented accuracy of systolic and

diastolic BPs to 1 mm Hg by

company developing Omron BP cuff;

designated protocol for taking BP

average three BP readings to

determine BP.

3 6 9

C H A P T E R

1 2

C ritic

a l A p p ra is a l fo r N u rs in g P ra c tic

e

12. Describe the procedures for data collection.

13. Describe the statistical analyses used.

a. List the statistical procedures used to describe the sample (Grove, 2007).

b. Was the level of significance or alpha identified? If so, indicate what it was (0.05, 0.01,

or 0.001).

c. Complete the following table with the analysis techniques conducted in the study: (1)

identify the focus (description, relationships, or differences) for each analysis technique;

(2) list the statistical analysis technique performed; (3) list the statistic; (4) provide

the specific results; and (5) identify the probability (p) of the statistical significance

achieved by the result (Grove, 2007; Grove et al., 2013; Hoare & Hoe, 2013; Plichta &

Kelvin, 2013).

14. Describe the researcher’s interpretation of findings.

a. Are the findings related back to the study framework? If so, do the findings support the

study framework?

b. Which findings are consistent with those expected?

c. Which findings were not expected?

d. Are the findings consistent with previous research findings? (Fawcett & Garity, 2009; Grove

et al., 2013; Hoare & Hoe, 2013)

15. What study limitations did the researcher identify?

16. What conclusions did the researchers identify based on their interpretation of the study

findings?

17. How did the researcher generalize the findings?

18. What were the implications of the findings for nursing practice?

19. What suggestions for further study were identified?

20. Is the description of the study sufficiently clear for replication?

Step 2: Determining the Strengths and Weaknesses in Studies The second step in critically appraising studies requires determining strengths and weak-

nesses in the studies. To do this, you must have knowledge of what each step of the research

process should be like from expert sources such as this text and other research sources

Purpose of Analysis Analysis Technique Statistic Results Probability (p)

Description of subjects’ pulse rate Mean

Standard deviation

Range

M

SD

range

71.52

5.62

58-97

Difference between adult males

and females on blood pressure

t-Test t 3.75 p¼0.001

Differences of diet group,

exercise group, and

comparison group for

pounds lost in adolescents

Analysis of variance F 4.27 p¼0.04

Relationship of depression and

anxiety in older adults

Pearson correlation r 0.46 p¼0.03

370 CHAPTER 12 Critical Appraisal for Nursing Practice

(Aberson, 2010; Bialocerkowski et al., 2010; Brown, 2014; Creswell, 2014; DeVon et al., 2007;

Doran, 2011; Fawcett & Garity, 2009; Grove, 2007; Grove et al., 2013; Hoare & Hoe, 2013;

Hoe & Hoare, 2012; Morrison, Hoppe, Gillmore, Kluver, Higa, & Wells, 2009; O’Mathuna

et al., 2011; Ryan-Wenger, 2010; Santacroce, Maccarelli, & Grey, 2004; Shadish et al., 2002;

Waltz et al., 2010). The ideal ways to conduct the steps of the research process are then com-

pared with the actual study steps. During this comparison, you examine the extent to which the

researcher followed the rules for an ideal study, and the study elements are examined for

strengths and weaknesses.

You also need to examine the logical links or flow of the steps in the study being appraised. For

example, the problem needs to provide background and direction for the statement of the purpose.

The variables identified in the study purpose need to be consistent with the variables identified in

the research objectives, questions, or hypotheses. The variables identified in the research objectives,

questions, or hypotheses need to be conceptually defined in light of the study framework. The con-

ceptual definitions should provide the basis for the development of operational definitions. The

study design and analyses need to be appropriate for the investigation of the study purpose, as well

as for the specific objectives, questions, or hypotheses. Examining the quality and logical links

among the study steps will enable you to determine which steps are strengths and which steps

are weaknesses.

Guidelines for Determining the Strengths and Weaknesses in Studies The following questions were developed to help you examine the different steps of a study and

determine its strengths and weaknesses. The intent is not for you to answer each of these questions

but to read the questions and then make judgments about the steps in the study. You need to pro-

vide a rationale for your decisions and document from relevant research sources, such as those

listed previously in this section and in the references at the end of this chapter. For example,

you might decide that the study purpose is a strength because it addresses the study problem, clar-

ifies the focus of the study, and is feasible to investigate (Brown, 2014; Fawcett & Garity, 2009;

Hoe & Hoare, 2012).

1. Research problem and purpose

a. Is the problem significant to nursing and clinical practice (Brown, 2014)?

b. Does the purpose narrow and clarify the focus of the study (Creswell, 2014; Fawcett &

Garity, 2009)?

c. Was this study feasible to conduct in terms of money commitment, the researchers’ exper-

tise; availability of subjects, facilities, and equipment; and ethical considerations?

2. Review of literature

a. Is the literature review organized to demonstrate the progressive development of evidence

from previous research (Brown, 2014; Creswell, 2014; Hoe & Hoare, 2012)?

b. Is a clear and concise summary presented of the current empirical and theoretical knowl-

edge in the area of the study (O’Mathuna et al., 2011)?

c. Does the literature review summary identify what is known and not known about the

research problem and provide direction for the formation of the research purpose?

3. Study framework

a. Is the framework presented with clarity? If a model or conceptual map of the framework is

present, is it adequate to explain the phenomenon of concern (Grove et al., 2013)?

b. Is the framework related to the body of knowledge in nursing and clinical practice?

371CHAPTER 12 Critical Appraisal for Nursing Practice

c. If a proposition from a theory is to be tested, is the proposition clearly identified and

linked to the study hypotheses (Alligood, 2010; Fawcett & Garity, 2009; Smith &

Liehr, 2008)?

4. Research objectives, questions, or hypotheses

a. Are the objectives, questions, or hypotheses expressed clearly?

b. Are the objectives, questions, or hypotheses logically linked to the research purpose?

c. Are hypotheses stated to direct the conduct of quasi-experimental and experimental

research (Creswell, 2014; Shadish et al., 2002)?

d. Are the objectives, questions, or hypotheses logically linked to the concepts and relation-

ships (propositions) in the framework (Chinn & Kramer, 2011; Fawcett & Garity, 2009;

Smith & Liehr, 2008)?

5. Variables

a. Are the variables reflective of the concepts identified in the framework?

b. Are the variables clearly defined (conceptually and operationally) and based on previous

research or theories (Chinn & Kramer, 2011; Grove et al., 2013; Smith & Liehr, 2008)?

c. Is the conceptual definition of a variable consistent with the operational definition?

6. Design

a. Is the design used in the study the most appropriate design to obtain the needed data

(Creswell, 2014; Grove et al., 2013; Hoe & Hoare, 2012)?

b. Does the design provide a means to examine all the objectives, questions, or hypotheses?

c. Is the treatment clearly described (Brown, 2002)? Is the treatment appropriate for

examining the study purpose and hypotheses? Does the study framework explain the

links between the treatment (independent variable) and the proposed outcomes

(dependent variables)? Was a protocol developed to promote consistent implementa-

tion of the treatment to ensure intervention fidelity (Morrison et al., 2009)? Did the

researcher monitor implementation of the treatment to ensure consistency

(Santacroce et al., 2004)? If the treatment was not consistently implemented, what

might be the impact on the findings?

d. Did the researcher identify the threats to design validity (statistical conclusion validity,

internal validity, construct validity, and external validity [see Chapter 8]) and minimize

them as much as possible (Grove et al., 2013; Shadish et al., 2002)?

e. If more than one group was used, did the groups appear equivalent?

f. If a treatment was implemented, were the subjects randomly assigned to the treatment

group or were the treatment and comparison groups matched? Were the treatment and

comparison group assignments appropriate for the purpose of the study?

7. Sample, population, and setting

a. Is the sampling method adequate to produce a representative sample? Are any subjects

excluded from the study because of age, socioeconomic status, or ethnicity, without a

sound rationale?

b. Did the sample include an understudied population, such as young people, older adults, or

minority group?

c. Were the sampling criteria (inclusion and exclusion) appropriate for the type of study

conducted (O’Mathuna et al., 2011)?

d. Was a power analysis conducted to determine sample size? If a power analysis was

conducted, were the results of the analysis clearly described and used to determine the final

372 CHAPTER 12 Critical Appraisal for Nursing Practice

sample size? Was the attrition rate projected in determining the final sample size

(Aberson, 2010)?

e. Are the rights of human subjects protected (Creswell, 2014; Grove et al., 2013)?

f. Is the setting used in the study typical of clinical settings?

g. Was the rate of potential subjects’ refusal to participate in the study a problem? If so, how

might this weakness influence the findings?

h. Was sample attrition a problem? If so, how might this weakness influence the final sample

and the study results and findings (Aberson, 2010; Fawcett & Garity, 2009; Hoe &

Hoare, 2012)?

8. Measurements

a. Do the measurement methods selected for the study adequately measure the study vari-

ables? Should additional measurement methods have been used to improve the quality

of the study outcomes (Waltz et al., 2010)?

b. Do the measurement methods used in the study have adequate validity and reliability?

What additional reliability or validity testing is needed to improve the quality of the

measurement methods (Bialocerkowski et al., 2010; DeVon et al., 2007; Roberts &

Stone, 2003)?

c. Respond to the following questions, which are relevant to the measurement approaches

used in the study:

1) Scales and questionnaires

(a) Are the instruments clearly described?

(b) Are techniques to complete and score the instruments provided?

(c) Are the validity and reliability of the instruments described (DeVon et al., 2007)?

(d) Did the researcher reexamine the validity and reliability of the instruments for the

present sample?

(e) If the instrument was developed for the study, is the instrument development

process described (Grove et al., 2013; Waltz et al., 2010)?

2) Observation

(a) Is what is to be observed clearly identified and defined?

(b) Is interrater reliability described?

(c) Are the techniques for recording observations described (Waltz et al., 2010)?

3) Interviews

(a) Do the interview questions address concerns expressed in the research problem?

(b) Are the interview questions relevant for the research purpose and objectives,

questions, or hypotheses (Grove et al., 2013; Waltz et al., 2010)?

4) Physiological measures

(a) Are the physiological measures or instruments clearly described (Ryan-Wenger,

2010)? If appropriate, are the brand names of the instruments identified, such as

Space Labs or Hewlett-Packard?

(b) Are the accuracy, precision, and error of the physiological instruments discussed

(Ryan-Wenger, 2010)?

(c) Are the physiological measures appropriate for the research purpose and objectives,

questions, or hypotheses?

(d) Are the methods for recording data from the physiological measures clearly

described? Is the recording of data consistent?

373CHAPTER 12 Critical Appraisal for Nursing Practice

9. Data collection

a. Is the data collection process clearly described (Fawcett & Garity, 2009; Grove et al., 2013)?

b. Are the forms used to collect data organized to facilitate computerizing the data?

c. Is the training of data collectors clearly described and adequate?

d. Is the data collection process conducted in a consistent manner?

e. Are the data collection methods ethical?

f. Do the data collected address the research objectives, questions, or hypotheses?

g. Did any adverse events occur during data collection, and were these appropriately

managed?

10. Data analysis

a. Are data analysis procedures appropriate for the type of data collected (Grove, 2007; Hoare

& Hoe, 2013; Plichta & Kelvin, 2013)?

b. Are data analysis procedures clearly described? Did the researcher address any problem

with missing data, and explain how this problem was managed?

c. Do the data analysis techniques address the study purpose and the research objectives,

questions, or hypotheses (Fawcett & Garity, 2009; Grove et al., 2013; Hoare &

Hoe, 2013)?

d. Are the results presented in an understandable way by narrative, tables, or figures or a

combination of methods (APA, 2010)?

e. Is the sample size sufficient to detect significant differences, if they are present?

f. Was a power analysis conducted for nonsignificant results (Aberson, 2010)?

g. Are the results interpreted appropriately?

11. Interpretation of findings

a. Are findings discussed in relation to each objective, question, or hypothesis?

b. Are various explanations for significant and nonsignificant findings examined?

c. Are the findings clinically important (O’Mathuna et al., 2011)?

d. Are the findings linked to the study framework (Smith & Liehr, 2008)?

e. Are the findings consistent with the findings of previous studies in this area?

f. Do the conclusions fit the findings from this study and previous studies?

g. Does the study have limitations not identified by the researcher?

h. Did the researcher generalize the findings appropriately?

i. Were the identified implications for practice appropriate based on the study findings and

on the findings from previous research (Brown, 2014; Fawcett & Garity, 2009; Hoe &

Hoare, 2012)?

j. Were quality suggestions made for future research (O’Mathuna et al., 2011)?

Step 3: Evaluating the Credibility and Meaning of Study Findings Evaluating the credibility and meaning of study findings involves determining the validity, sig-

nificance, and meaning of the study by examining the relationships among the steps of the study,

study findings, and previous studies. The steps of the study are evaluated in light of previous

studies, such as an evaluation of present hypotheses based on previous hypotheses, present design

based on previous designs, and present methods of measuring variables based on previous

methods of measurement. The findings of the present study are also examined in light of the

374 CHAPTER 12 Critical Appraisal for Nursing Practice

findings of previous studies. Evaluation builds on conclusions reached during the first two stages

of the critical appraisal so the credibility, validity, and meaning of the study findings can be

determined.

Guidelines for Evaluating the Credibility and Meaning of Study Findings

You need to reexamine the findings, conclusions, and implications sections of the study and the

researchers’ suggestions for further study. Using the following questions as a guide, summarize

your evaluation of the study and document your responses.

1. What rival hypotheses can be suggested for the findings?

2. Do the findings from this study build on the findings of previous studies? You need to read some

of the other relevant studies cited by the researchers to address this question.

3. When the findings are examined in light of previous studies, what is now known and not known

about the phenomenon under study?

4. Do you believe the study findings are valid? How much confidence can be placed in the study

findings (Fawcett & Garity, 2009)?

5. Could the limitations of the study have been corrected?

6. To what populations can the findings be generalized?

7. What questions emerge from the findings, and does the researcher identify them?

8. What implications do the findings have for nursing practice? (Brown, 2014; Craig & Smyth,

2012; Hoe & Hoare, 2012; O’Mathuna et al., 2011)?

The evaluation of a research report should also include a final discussion of the quality of

the report. This discussion should include an expert opinion of the study’s quality and contri-

bution to nursing knowledge and practice (Brown, 2014; Hoare & Hoe, 2013; O’Mathuna

et al., 2011).

EXAMPLE OF A CRITICAL APPRAISAL OF A QUANTITATIVE STUDY

A critical appraisal was conducted of the quasi-experimental study by Shipowick, Moore, Corbett, &

Bindler (2009) and is presented as an example in this chapter. The research report, “Vitamin D

and Depressive Symptoms in Women During the Winter: A Pilot Study,” is included in this section.

This study examined the effects of a vitamin D3 supplement on depressive symptoms in women

with low vitamin D levels. This study is followed by the three steps for critically appraising a quan-

titative study:

• Step 1: Identifying the steps of the research process

• Step 2: Determining study strengths and weaknesses

• Step 3: Evaluating the credibility and meaning of study findings

Nursing students and practicing nurses usually conduct critical appraisals that are focused on

identifying the steps of the research process in a study. This type of critical appraisal may be written

in outline format, with headings identifying the steps of the research process. A more in-depth

critical appraisal includes not only this step but also determines study strengths and weaknesses

and evaluates the study findings’ credibility and meaning. We encourage you to read the Shipowick

and associates’ (2009) study, and conduct a comprehensive critical appraisal using the guidelines

presented earlier in this chapter. Compare your ideas with the critical appraisal presented in this

section.

375CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE

Quantitative Study

Continued

377CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

378 CHAPTER 12 Critical Appraisal for Nursing Practice

Continued

379CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

Critical Appraisal Step 1: Steps of the Research Process 1. Abstract: The study abstract included the problem, sample of women with serum vitamin D levels less than

40 ng/mL, sample size of nine, with six completing the study, treatment of vitamin D3 supplementation,

dependent variable of depressive symptoms measured with the Beck Depression Inventory II (BDI-II),

key results, and conclusions. The study purpose and design were not included in the abstract.

2. Problem:

“Research shows that women are more susceptible to depression than men (Sloan & Kornstein, 2003).

Women under 40 years of age are four times more likely to have seasonal affective disorder than men

(Gaines, 2005). According to the World Health Organization (WHO), by 2020, depression will be the leading

cause of disability worldwide (WHO, 2000). Studies indicate that vitamin D deficiency is associated with

increased depressive symptoms (Armstrong et al., 2007; Jorde et al., 2006). Thus, vitamin D supplementa-

tion may provide a natural, inexpensive, and accessible remedy for seasonal mood fluctuations and an

adjunct for individuals with depressive symptoms.” (Shipowick et al., 2009, p. 221)

3. Purpose: The purpose is not clearly stated in the study, but it is evident from the title and problem that the

purpose of this quasi-experimental study was to examine the effect of vitamin D3 supplementation on

depressive symptoms of women during the winter months.

(From Shipowick, C. D., Moore, C. B., Corbett, C., & Bindler, R. [2009]. Vitamin D and depressive symptoms in women during the winter: A pilot study. Applied Nursing Research, 22[3], 221-225.)

380 CHAPTER 12 Critical Appraisal for Nursing Practice

4. Literature review: A minimal review of literature is presented in this research report. Shipowick and

associates (2009) identified three studies that linked vitamin D to depression. Armstrong and co-workers

(2007) found that patients with the lowest vitamin D levels had the highest anxiety and depression scores.

This suggested a link between anxious and depressive symptoms and vitamin D deficiency. Berk and

colleagues (2007) found that a higher proportion of depressed patients were vitamin D–deficient, supporting

the link between depression and vitamin D level. Jorde and associates (2005) found a “statistically significant

association between serum vitamin D levels and the Beck Depression Inventory (BDI) scores, indicating that

a low serum level was indicative of high depressive symptoms” (Shipowick et al., 2009; p. 223).

5. Framework: A biopsychological model is appropriate and clearly presented as the framework for this study.

Shipowick and co-workers (2009) described their model in the following way:

“Vitamin D3 is hydroxylated in the liver to become 25-OH vitamin D, the major circulating form of vitamin D. It

is activated in the kidneys to become the hormone 1,25-OH vitamin D where it is tightly regulated. Certain

organs including the brain also have the capacity to activate vitamin D (Holick & Jenkins, 2003). Both unac-

tivated and activated vitamin D can cross the blood-brain barrier (Kiraly et al., 2006). Based on these data, a

biopsychological framework of vitamin D as a hormone that influences depressive symptoms served as an

emerging model (see Figure 12-1 of this study as follows). Three physiological pathways between vitamin D

and depressive symptoms were identified: (a) vitamin D in its active form in the body has been shown to

stimulate serotonin (Gaines, 2005), a neurotransmitter that is associated with mood elevation; (b) vitamin

D has been associated with down-regulation of glucocorticoid receptor gene activation, which is found to

be unregulated in depression; and (c) vitamin D has also been found to be neuroprotective, shielding neurons

from toxins such as glucocorticoids and other excitotoxic insults (Obradovic, Gronemeyer, Lutz, & Rein,

2006).” (Shipowick et al., 2009, p. 222)

Continued

Oral Vitamin D3 Supplementation

LIVER

KIDNEYS

25(OH) D

THE BLOOD

Increases Serotonin

Protects Neurons from Toxins

Decreases Glucocorticoid

Receptors

BRAIN

Activated Vitamin D

(1,25[OH]D)

BARRIER

1,25(OH) D

FIG 12-1 The biopsychological model of vitamin D, a hormone that elevates mood. (Adapted from Holick, M., & Jenkins, M. (2003). The UV advantage. New York: Ibooks; and Shipowick, C. D., Moore, C. B., Corbett, C., & Bindler, R. [2009]. Vitamin D and depressive symptoms in women during the winter: A pilot study. Applied Nursing Research, 22[3], 222.)

381CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

6. Research questions and hypothesis

“The following research questions guided the study: (a) Is there a significant relationship between serum

vitamin D levels and depressive symptoms? and (b) Do depressive symptoms in women with low serum

vitamin D levels improve 8 weeks after initiation of vitamin D3 supplementation (5000 IU [International Units]

daily) during the fall and winter?” (Shipowick et al., 2009, pp. 221-222)

7. Variables: Shipowick and co-workers (2009) clearly presented the conceptual and operational definitions for

the independent variable (vitamin D3 supplementation) and dependent variables (depression symptoms and

25-OH vitamin D). The conceptual definitions are linked to the study framework, and the operational defini-

tions are linked to the study methodology. The conceptual and operational definitions for these variables are

provided in the following excerpt.

Independent Variable: Vitamin D3 Supplementation

Conceptual Definition

Vitamin D3 improves depressive symptoms through:

“. . .three physiological pathways: (a) its active form in the body stimulates serotonin, a neurotransmitter

associated with mood elevations; (b) it is associated with down-regulation of glucocorticoid receptor gene

activation, which is up-regulated in depression; and (c) it is neuroprotective, shielding neurons from toxins

such as glucocorticoids and other excitotoxic insults.” (Shipowick et al., 2009, p. 222; see Figure 12-1)

Operational Definition

The treatment of vitamin D3 supplementation was implemented by providing the subjects with 5000 IU of vitamin

D3 daily for 8 weeks.

Dependent Variable: Depressive Symptoms

Conceptual Definition

Depressive symptoms are influenced by levels of serotonin, actions of glucocorticoid receptors, and neurons exposed

to toxins, which are influenced by vitamin D (see Figure 12-1).

Operational Definition

Depressive symptoms were measured with the Beck Depression Inventory II (BDI-II), a Likert scale.

Dependent Variable: 25-OH Vitamin D

Conceptual Definition

“Vitamin D3 is hydroxylated in the liver to become 25-OH vitamin D, the major circulating form of vitamin D.”

(Shipowick et al., 2009, p. 222; see Figure 12-1)

Operational Definition

25-OH vitamin D was measured with a biochemical laboratory test. The level was pretested to determine if the

women met the sample criteria of a value<40 ng/ml. The 25-OH was post-tested to determine if the participants’ value was>40 ng/ml. 8. Attribute variables: The only attribute variable identified was age.

9. Research design: The research design was clearly identified as “a quasi-experimental pretest-posttest

design with female participants acting as their own pre-post control” (Shipowick et al., 2009, p. 223).

a. Treatment or intervention:

“Per usual medical care at the clinic, participants who had blood tests that indicated serum vitamin D

levels below 40 ng/ml were advised to initiate vitamin D3 supplementation (5000 IU) by their physicians.

Before vitamin D3 supplementation, women were informed of the research opportunity. Women agree-

ing to participate completed the BDI-II survey prior to initiating the vitamin D3 supplementation.” (Shipo-

wick, 2009, pp. 223-224)

The women participants took the 5000 IU vitamin D3 supplement daily for 8 weeks.

b. Group assignment: The study has only one group of 9 women who served as their own control. This

means they completed BDI-II scale as the pretest and then took the 5000 IU of vitamin D3 supplement

382 CHAPTER 12 Critical Appraisal for Nursing Practice

treatmentfor8weeksandthenwerepost-testedfordepressedsymptomswiththeBDI-II.Thus,thepretest

isconsideredthecontrolandthepost-testisconductedtodeterminetheeffectofthetreatment.Thepretest

scores are compared with the post-test scores to determine the effect of the vitamin D3 treatment

(Grove et al., 2013).

10. Sample

a. Sample criteria: Sample inclusion criteria were females being treated for vitamin D deficiency or insuf-

ficiency with vitamin D level below 40 ng/mL as measured by the serum level of 25-OH vitamin D.

“The following were excluded from the study: (a) those with mental impairments such as dementia or

language barriers that may have inhibited answering written questions; (b) women who were using or

planned to use tanning beds or other phototherapy; (c) women who planned on traveling to sunnier,

more tropical areas (e.g., Mexico, Hawaii, Arizona) during the winter; and (d) women taking or planning

to take antidepressants.” (Shipowick et al., 2009, p. 223)

b. Sampling method: Nonprobability sample of convenience is indicated by the women being asked to take

part in the study, and then they voluntarily participated.

c. Sample size and attrition: The sample size was N¼9. Three participants were lost from the study, indi- cating a 33% attrition rate, and six (67%) completed the study. This study included no mention of power

analysis or acceptance rate for study participation.

11. Institutional review board and type of consent:

“Following university institutional review board approval and the approval of the clinical agency where the

study was carried out. . .” (Shipowick et al., p. 223). “Before vitamin D3 supplementation, women were

informed of the research opportunity. Women agreeing to participate completed the BDI-II.” (Shipowick

et al., 2009, p. 224)

12. Study setting: The setting was a medical clinic in southeastern Washington state. The women took the

vitamin D3 supplements daily in their homes.

13. Measurement methods: The study included the dependent variable depressivesymptoms that was measured

with one measurement method, the BDI-II Likert scale. However, the sample inclusion criteria required that

the women have a serum 25-OH vitamin D level prior to the study, and this level was also post-tested so it

might be considered a second dependent variable. Therefore both measurement methods are included in

the following table.

Continued

Name of

Measurement

Method Author

Type of

Measurement

Method

Level of

Measurement

Reliability or

Precision

Validity or

Accuracy

Beck

Depression

Inventory II

(BDI-II)

Beck Likert Scale Interval BDI-II, commonly

used

depression

screening tool

with

demonstrated

reliability; for

this study, the

BDI-II had

Cronbach

alphas of 0.81

at baseline and

0.95 at

follow-up.

BDI-II had

demonstrated

validity in

previous

studies and

was used in

Jorde and

associates’

(2005) study

cited in the

literature

review;

successive use

validity because

scale is used in

previous

studies and

current study

383CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

14. Data collection procedures: The women were screened for their 25-OH vitamin D level in January to March.

If the vitamin D level was less than 40 ng/mL, the women were informed of the study and asked to par-

ticipate. Those volunteering to participate in the study then were asked to complete the BDI-II and then

started on the 5000 IU of vitamin D3 every day for 8 weeks. At the end of the eighth week, the women

again were asked to complete the BDI-II to document their depression symptoms. The 25-OH vitamin

D level was also determined. Those involved in treatment implementation and data collection were not

identified. The training of individuals for data collection and implementation of the treatment was not

described.

15. Statistical analyses: The Statistical Package for the Social Sciences (SPSS) 14.0 was used to perform the

statistical analyses. Only the six participants completing the study were included in the analyses. The ana-

lyses conducted are summarized in the following table.

Name of

Measurement

Method Author

Type of

Measurement

Method

Level of

Measurement

Reliability or

Precision

Validity or

Accuracy

25-OH vitamin

D level

Biochemical

measure

Physiological

measurement

method—

laboratory test

of serum

vitamin D level

Ratio Precision of

laboratory test

not addressed

in the study; no

discussion of

the collection

and analysis of

the serum for

the vitamin D

levels; serum

collection done

in same clinic

for pre- and

post-tests

Vitamin D is

hydroxylated in

the liver to

become 25-OH

vitamin D, the

major

circulating form

of vitamin D;

thus, 25-OH

vitamin D is the

most accurate

measure of

vitamin D in the

body to identify

deficiencies.

Purpose of Analysis

Analysis

Technique Statistic Result

Probability

(p)

Description of subjects’ age Mean x 42.2

Standard

deviation

SD 13.17

Range Range 23-55

Description of depression

symptoms measured with

the BDI-II

Pretest

Post-test

Mean x 31.8333

21.1667

Standard

deviation

SD 4.79236

11.07098

Average SD 7.7616

Differences

in means

Mean

difference

10.66667

Line graph Figure 12-3

384 CHAPTER 12 Critical Appraisal for Nursing Practice

Continued

Purpose of Analysis

Analysis

Technique Statistic Result

Probability

(p)

Description of 25-OH vitamin

D levels

Pretest

Post-test

Mean x 21.8333

48.1667

Standard

deviation

SD 8.32867

Average SD 15.68014

Differences

in means

Mean

difference

�26.33333

Line graph Figure 12-2

Difference between pretest

and post-test on

depressive symptoms

Dependent

or paired

t-test

t 3.366 p¼0.020

Difference between pretest

and post-test for 25-OH

vitamin D level

Dependent

or paired

t-test

t �4.114 p¼0.009

Vitamin D Levels

B lo

o d

S e ru

m D

L e v e l

90

80

70

60

50

40

30

20

10

0 1 2 3

Patient Original Level D D After Supplementation

4 5 6

FIG 12-2 Comparing vitamin D levels before and after supplementation. This graph shows that vitamin D3 supplementation is associated with an increase in serum 25-OH vitamin D levels by an average of 27 ng/mL after 8 weeks. (From Shipowick, C. D., Moore, C. B., Corbett, C., & Bindler, R. (2009). Vitamin D and depressive symptoms in women during the winter: A pilot study. Applied Nursing Research, 22[3], 223.)

385CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

16. Interpretation of findings:

“Following supplementation, serum vitamin D levels increased in all participants with an average increase of

27 ng/ml. At the prescribed intake of 5000 IU daily, a significant reduction in depressive symptoms was real-

ized after supplementation. Further, among the three women with a postsupplementation serum vitamin D

level greater than 40, all had BDI-II scores of 14 or less, suggestive of normal mood with minimal depressive

symptoms.” (Shipowick et al., 2009, p. 224)

17. Limitations of the study: The small sample size was identified as a limitation. The reasons for three of the

women not achieving serum vitamin D3 levels above 40 ng/mL were unclear. Perhaps they were not taking

the vitamin D3 consistently or needed longer than 8 weeks to achieve optimal vitamin D levels of 40 to 65 ng/

mL. The design was identified as a limitation, and Shipowick and colleagues (2009) recommended the use of

stronger designs in future studies.

18. Conclusions:

“In summary, this pilot study provides evidence to suggest that women who suffer from seasonal depres-

sive symptoms may benefit from vitamin D3 supplementation if serum vitamin D levels are low (<40 ng/ml).

These findings are consistent with other studies that indicate that higher vitamin D levels improve sense of

well-being (Armstrong et al., 2007; Berk et al., 2007; Jorde et al., 2005).” (Shipowick et al., 2009, p. 225)

19. Implications for nursing: The researchers provide no specific implications for nursing practice.

20. Suggestions for further research:

“Further research with a larger sample size and stronger design is warranted to continue to investigate the

clinical utility of vitamin D3 supplementation. . . . Replication of this study with a larger, adequately powered

sample is needed to provide a more definitive understanding of the relationship between vitamin D supple-

mentation and seasonal depressive symptoms. Additionally, further research to determine factors related to

vitamin D3 dosing is needed. . . . More frequent analyses of serum vitamin D levels and measuring adher-

ence to supplementation are warranted in future studies. Future studies should be conducted with a ran-

domized and blinded design to account for placebo effect.” (Shipowick et al., 2009, p. 225)

B D

I S

c o

re

1

45

40

35

30

25

20

15

10

5

0 2 3

Patient BDI Original Score BDI After D Supplementation

BDI

4 5 6

FIG 12-3 Comparing BDI-II scores before and after supplementation. This graph shows that vitamin D supplementation is associated with a decline (improved mood: a negative correlations) in BDI-II scores of an average of 10 points. (From Shipowick, C. D., Moore, C. B., Corbett, C., & Bindler, R. [2009]. Vitamin D and depressive symptoms in women during the winter: A pilot study. Applied Nursing Research, 22[3], 223.)

386 CHAPTER 12 Critical Appraisal for Nursing Practice

Step 2: Study Strengths and Weaknesses This section discusses the strengths and weaknesses of the steps of the research process and the logical links among

these steps. The abstract, problem, purpose, literature review, framework, methodology, results, and discussion ele-

ments of the Shipowick and associates’ (2009) article are critically appraised.

Abstract

The abstract is very brief and includes the study problem, sample size, significant results, and conclusions. The

abstract would have been strengthened by including the study purpose and design (APA, 2010).

Problem and Purpose

The researchproblem isclearly identifiedinthe abstract and inthe first few paragraphs ofthe article.Thisisa significant

clinicalproblem thatcouldbedetected, managed, and monitoredby nursesincollaborationwith physicians. VitaminD

insufficiencyisaverycommonprobleminhealthcaretoday, as isdepression.Additionalresearchisneededtodetermine

theimpactofvitaminDsupplementationondepressionsymptoms(Brown,2014;O’Mathunaetal.,2011).Thepurpose

is not clearly stated in the study, but is inferred from the study title and research questions (Creswell, 2014).

Literature Review

The literature review is brief, including only three studies, and would have been strengthened by the addition of more

correlational and quasi-experimental studies focused on the impact of vitamin D supplementation on mood. However,

the three studies cited provide a basis for conducting this study. The references cited in the study and the reference list

included some errors, such as the Armstrong and co-workers’ study having a 2006 date in the research report, but the

source is actually a 2007 publication. The Kornstein and Sloan (2003) article is really Sloan and Kornstein (2003), and

the pages for the Gaines (2005) article are pages 30 to 33. In addition, a final summary of what is known and not known

about the problem studied would have added clarity to the literature review (Grove et al., 2013).

Framework

Theframeworksectionisamajorstrengthofthisstudy.Shipowickandcolleagues(2009)providedaclear,concise,appro-

priate physiological framework for theirstudy (Smith & Liehr, 2008). The biopsychological modelpresentedinthe study

providesaclearlinkofhowvitaminDasahormoneelevatesmoodanddecreasesdepressivesymptoms(Figure12-1).The

study framework also provided clear conceptual definitions of the independent and dependent variables, and these con-

ceptual definitions provided a basis for operationalizing these variables in this study (Grove et al., 2013).

Methods

The study design is a single group pretest and post-test, with subjects serving as their own control. This is a weak design

becausethereisonlyatreatmentgroupandnocomparisongrouptodetermineifthetreatmentiseffectiveorifthechange

from pretest to post-test iscaused byextraneousvariables(Creswell, 2014; Shadish etal., 2002). However, the designdoes

provide a means to examine the two research questions. The sample size was small, N¼9, and no power analysis was conducted to determine an adequate sample size for the study (Aberson, 2010). In addition, the study has a high attrition

rate (33.3%), with threesubjects dropping out of the study before the 8 weeks of the treatment were completed. No ratio-

nale is provided for why the subjects did not complete the study. However, the study results were significant, indicating

that the sample was adequately powered, and no type II error occurred (Aberson, 2010; Grove et al., 2013).

The sampling method was one of convenience, and there is greater potential for sampling error with a nonprob-

ability sample than a random sample. However, the researchers provide very strong sample inclusion and exclusion

criteria that limit the potential effects of extraneous variables and improve the representativeness of the sample.

Only the age of the participants is given, and it would have been helpful to include the ethnicity and history of

depression when describing the sample. The study seemed ethical because it was approved for conduct by the IRBs

of the university and clinic and informed consent was obtained from the study participants (Hoe & Hoare, 2012).

The study included a strong treatment of vitamin D3 supplementation, 5000 IU daily for 8 weeks. However, the

researchers needed to provide more detail about how the treatment was implemented. If the treatment was imple-

mented by more than one person, the training to promote consistency in the administration of treatment needed to

be addressed (Santacroce et al., 2004). Continued

387CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

The BDI-II is a strong measurement strategy for depression and has been used in many other studies over the years.

In addition, the Cronbach alphas were strong and supported the reliability of the BDI-II in this study. However, the

measurement section would have been strengthened by a more detailed discussion of the reliability and validity of

the BDI-II based on previous research (DeVon et al., 2007; Hoe & Hoare, 2012; Roberts & Stone, 2003; Waltz et al.,

2010). The researchers discussed the scoring for the BDI-II and indicated that the scores could range from 0 to 63.

They also indicated the meaning for the different scores, with normal scores from 0 to 13, mild depression scores

from 14 to 19, moderate depression scores from 20 to 28, and severe depression scores from 29 to 63.

The 25-OH vitamin D level is the strongest measurement of vitamin D levels in the body and is the most effective

way to identify women with insufficient vitamin D levels. Additional discussion was needed, however, of the pre-

cision and accuracy of the laboratory in determining the 25-OH vitamin D levels in this study (DeKeyser & Pugh,

1990). Shipowick and colleagues (2009) did not indicate who collected the data. If more than one person collected

data, the reliability or consistency of the data collection process needs to be addressed (Grove et al., 20013;

Santacroce et al., 2004).

Results

The statistical techniques used to analyze data from the BDI-II and the 25-OH vitamin D levels were clearly iden-

tified and appropriate. The analysis techniques (descriptive and inferential) are appropriate for the level of mea-

surement of the variables (Grove, 2007; Plichta & Kelvin, 2013). The results are clearly and concisely presented

in narrative form, table, and graphs to facilitate understanding. The sample size was small but adequate to detect

significant differences between the pretests and post-tests for depression symptoms and vitamin D levels. This sec-

tion would have been strengthened by linking the results to the two research questions (Hoare & Hoe, 2013).

Discussion

The findings were as expected, and the statistical and clinical significance of the findings are clearly addressed

(Brown, 2014; Hoare & Hoe, 2013). The findings were supportive of the study framework and consistent with pre-

vious research, which was documented in the article. The conclusions were clearly expressed and appropriate based

on the study results and findings. The researchers identified the study limitations and provided specific appropriate

ideas for future studies to overcome the limitations of this study. A randomized clinical trial design was recom-

mended, which would greatly strengthen the quality of the study and credibility of the findings (Mittlbock,

2008). The researchers did not make recommendations for nursing practice but focused on the need for additional

research before making changes in practice.

Step 3: Credibility and Meaning of the Study Findings The Shipowick and associates’ (2009) study examined significant clinical problems (seasonal depression and vita-

min D deficiencies in women) and examined the effectiveness of vitamin D3 supplementation for these problems.

This study has many strengths and few weaknesses, which leads one to conclude that the findings are credible and an

accurate reflection of reality. The findings—women who suffer from seasonal depressive symptoms may benefit

from vitamin D3 supplementation if their vitamin D levels are low—are supportive of the study framework

(Figure 12-1 of this example). In addition, these findings are consistent with those of previous researchers

(Armstrong et al., 2007; Berk et al., 2007; Jorde et al., 2006).

The findings of the Shipowick and co-workers’ (2009) study increase our understanding of the link between vita-

min D and depressive symptoms in women and provide direction for future studies. Vitamin D3 has potential to be

an effective treatment for seasonal depression in women with low vitamin D levels. Because of the small sample size

and limitations of the study design, however, the researchers do not recommend generalizing these findings from the

sample to the population. Shipowick and colleagues provided excellent, detailed directions for future studies. They

did not recommend using the findings in practice at this time. Clinically, patients are currently being tested for

deficiencies in vitamin D levels and treated with 5000 IU of vitamin D3, even though research is still inadequate

to recommend treatment of depressive symptoms with vitamin D. This is an important area for further research.

388 CHAPTER 12 Critical Appraisal for Nursing Practice

UNDERSTANDING THE QUALITATIVE RESEARCH CRITICAL APPRAISAL PROCESS

Nurses in every phase and field of practice need experience in critically appraising qualitative and

quantitative studies. Although qualitative studies require a different approach to critical appraisal

than quantitative studies (Sandelowski, 2008), appraisal in both cases has a common purpose—

determining the rigor with which the methods were applied and the extent to which the conclu-

sions of the study were trustworthy. Critical appraisal of qualitative studies focuses on how the

integrity of the design and methods will affect the credibility and meaningfulness of the findings

and their usefulness in clinical practice (Pickler, 2007). Different criteria have been used to appraise

qualitative studies critically (Burns, 1989; Clissett, 2008; Cohen & Crabtree, 2008; Morse, 1991;

Schoe, H�strop, Lyngs�, Larsen, & Poulsen, 2011). We include a set of criteria synthesized from these published criteria and have organized them into three broad steps similar to those used

for critical appraisal of quantitative studies. Therefore the qualitative research critical appraisal

process consists of (1) identifying the components of the qualitative research process in studies, (2)

determining study strengths and weaknesses, and (3) evaluating the trustworthiness and meaning

of study findings. Each step includes the questions to be addressed to reflect the philosophical ori-

entation of qualitative research.

Step 1: Identifying the Components of the Qualitative Research Process in Studies The first step of the critical appraisal process is similar to looking at a map of an entire country

and observing the boundaries and key topographical features, such as mountains and lakes. You

might find the cities to which you want to travel and identify the best route to travel from one to

the other. At this point, you are not identifying the quality of the roads or unique aspects of the

various cities you want to visit. This type of overview allows you to orient yourself to the country.

In the same way, the first step of the critical appraisal process provides you with an overview of

the study.

Guidelines for Identifying the Components of the Research Process in Qualitative Studies

Begin your appraisal by looking at the entire article, beginning with the title and abstract (review

the principles presented in Box 12-1). What is the title? Is the abstract descriptive of the study?

Continue your review and find the major headings of the article to determine if the major com-

ponents of a research report are present.

Were the following parts of the research report plainly identified (APA, 2010)?

• Introduction section, with the problem, purpose, literature review, framework (if applicable),

and objectives and questions

• Methods section, with the qualitative approach, sample, and data collection methods

• Results section, with the specific results presented as themes and supported by direct quotes

from participants

• Discussion section, with the findings, conclusions, limitations, transferability to other groups,

implications for practice, and suggestions for future research (Brown, 2014; Grove et al., 2013)

As you read the study report in more depth, identify and describe each of the following aspects

of the study and its report.

389CHAPTER 12 Critical Appraisal for Nursing Practice

Guidelines for Identifying the Components of a Qualitative Study 1. Introduction

a. Describe the qualifications of the authors to conduct the study. Did the authors acknowl-

edge any potential bias or personal connection related to the study topic and steps taken to

reduce bias?

b. Discuss the clarity of the article title. Is the title clearly focused and does it include the

focus and population of the study? Does the title indicate the type of study conducted—

phenomenology, grounded theory, ethnography, exploratory-descriptive qualitative, or

historical research (Creswell, 2013, 2014; Fawcett & Garity, 2009; Hoe & Hoare, 2012)?

c. Discuss the quality of the abstract (includes purpose, qualitative approach, sample, and key

results; APA, 2010).

2. State the problem.

a. Significance of the problem

b. Background of the problem

c. Problem statement

3. State the purpose.

4. Examine the literature review.

a. Is the literature review identified as such? In some research articles, the literature review will

be identified clearly as a review of the literature; some authors may incorporate the review

into the background and significance.

b. Did the author cite quantitative and qualitative studies relevant to the focus of the study?

What other types of literature did the author include?

c. Identify the disciplines of the authors of studies cited in this paper and the journals in

which they published their studies. Does it appear that the author searched databases out-

side of the Cumulative Index to Nursing and Allied Health Literature (CINAHL) for relevant

studies?

d. Are the references current? Are classic or groundbreaking studies included, which may

be older?

e. Did the author evaluate or indicate the weaknesses of the available studies (Grove et al.,

2013; Hart, 2009)?

5. Identify the study framework or philosophical orientation of the study.

a. Did the authors cite primary sources to support the framework or philosophical orienta-

tion of the study?

b. If the study was a grounded theory study, did the researcher develop a theoretical descrip-

tion or diagram as part of the study findings (Creswell, 2013)?

6. List the research objectives (aims) or questions, if identified.

7. Identify the qualitative approach used to answer the research questions (phenomenology,

grounded theory, ethnography, exploratory-descriptive, historical, or other approach). If

the specific qualitative approach was not identified, what aspects of the method, such as nat-

ural settings or coding, indicate that a qualitative approach was used (Creswell, 2013;

Munhall, 2012)?

8. Describe the sample and setting.

a. Identify inclusion and exclusion criteria.

b. What methods did the researchers use to recruit participants?

c. Identify the sample size.

d. Identify the characteristics of the sample.

390 CHAPTER 12 Critical Appraisal for Nursing Practice

e. Discuss the IRB approval. Describe the informed consent process used in the study.

f. Did the researcher identify that participants might become upset during the collection of

data? If so, what measures were in place to address the safety and emotional needs of the

participants (Maxwell, 2013)?

g. Did any potential subjects refuse to participate? Did any of the participants start but not

finish the study?

h. Identify the study setting and indicate whether it is appropriate for the study purpose.

9. Describe the procedures for data collection.

a. What methods were used—interviews, focus groups, observation, or other?

b. Were multiple interviews with the same person conducted or were data collected one time

from each participant?

c. How were data recorded during data collection?

d. Did the researcher make field notes or journal entries (Creswell, 2014; Miles, Huberman, &

Saldana, 2014)?

10. Describe the data analysis processes.

a. How were the data prepared for analysis?

b. How were the data analyzed? Did the researcher cite a specific method of analysis and pro-

vide a primary source?

c. Was computer-assisted qualitative data management software used during the analysis?

d. Which methods were used to increase the trustworthiness of the findings (e.g., verification

of the accuracy of transcripts, immersion in the data, documentation of an audit trail, also

known as the record of decisions that were made during data collection and analysis, mem-

ber checking, independent analysis of a portion of the data by another researcher (Cohen &

Crabtree, 2008; Miles et al., 2014; Murphy & Yielder, 2010)?

11. Describe the researcher’s interpretation of findings.

a. Are the findings related back to the study framework (if applicable)?

b. Which findings were not expected?

c. Are the findings consistent with previous research findings (Fawcett & Garity, 2009)?

12. What study limitations did the researcher identify?

13. What conclusions did the researchers identify based on their interpretation of the study

findings?

14. Did the researcher indicate other groups to which these findings might be transferable or

applied?

15. What were the implications of the findings for nursing practice?

16. What suggestions were identified for further study?

Step 2: Determining the Strengths and Weaknesses in Studies At this step, the differences in the critical appraisal processes of quantitative and qualitative studies

become more obvious. However, the goal of the critical appraisal remains the same—determining

the strengths and weaknesses of the study. Knowledge of the different qualitative approaches and

data collection processes is needed to answer the questions during this step. You may want to refer

to Chapter 3 and supplement your knowledge with other sources, such as other texts, reference

books, and articles (Brown, 2014; Creswell, 2013, 2014; Fawcett & Garity, 2009; Grove et al.,

2013; Miles et al., 2014; Munhall, 2012; Petty, Thomson, & Stew, 2012; Sandelowski & Barroso,

2007). The actual methods of the study being appraised are compared to the expectations of qual-

itative experts, including the original proponents of different qualitative approaches. Because

391CHAPTER 12 Critical Appraisal for Nursing Practice

different qualitative experts agree less on the “rules” for implementing qualitative studies, using the

guidelines recommended by a specific expert in the method used by the researchers in the study is

important. The areas of consistency are strengths of the study, whereas areas of inconsistency may

indicate weaknesses of the study. The standards used for appraising the strength of qualitative stud-

ies are not quantitative (i.e., reliability of a scale�0.8); the person conducting the critical appraisal evaluates all aspects of a qualitative study and makes a judgment about its trustworthiness. Trust-

worthiness is a determination that a qualitative study is rigorous and of high quality. Trustwor-

thiness is the extent to which a qualitative study is dependable, confirmable, credible, and

transferable.

A thorough report of a qualitative study should include adequate information so that the

reader can assess the report dependability and confirmability of the study (Murphy & Yielder,

2010). Dependability and confirmability are similar to reliability of quantitative studies. Depend-

ability is documentation of steps taken and decisions made during analysis. Remember from

Chapter 3 that the researchers’ record of the analysis process is called an audit trail. Confirm-

ability is the extent to which other researchers can review the audit trail and agree that the

authors’ conclusions are logical (Murphy & Yielder, 2010). When a study’s findings are appraised

to be confirmable and dependable, they have more credibility. Credibility is the confidence of the

reader about the extent to which the researchers have produced results that reflect the views of

the participants; this is similar to validity in the critical appraisal of quantitative studies (Murphy

& Yielder, 2010). Petty and co-workers (2012) have explained that qualitative findings are not

generalizable, but are transferable or applicable in other settings with similar participants.

You need to appraise the rigor of the study methods by looking for information about the care-

fulness of data collection and thoroughness of the data analysis. The questions asked about each

component of the study will focus your attention on the rigor of the methods and the logical links

among the study elements. Logical links among the study elements are critical to the credibility of

the study (Cohen & Crabtree, 2008; Maxwell, 2013). For example, is the purpose of the study con-

sistent with the research questions? Are the purpose and research questions appropriate to address

the research problem? Is the selected qualitative approach the best way to answer the research ques-

tions? Similar to quantitative research, logical inconsistencies and improperly applied methods are

common weaknesses of qualitative studies. Because qualitative research has fewer rules, critically

appraising qualitative studies can seem daunting. The following questions provide a structure for

you to examine each aspect of the qualitative research process. Remember to consult other refer-

ences, as needed, to answer each question.

Guidelines for Determining the Strengths and Weaknesses in Studies 1. Research problem and purpose

a. Is the problem significant to nursing and clinical practice (Cohen & Crabtree, 2008)?

b. Does the purpose address the focus of the study?

2. Review of literature

a. Did the researchers provide a broad organized review of the literature that included dis-

ciplines other than nursing?

b. Did the literature review include adequate information to build a logical argument? Did the

author provide enough evidence to support the verdict that the study was needed?

c. Does the literature review summary identify what is known and not known about the

research problem and provide direction for the formation of the research purpose?

392 CHAPTER 12 Critical Appraisal for Nursing Practice

3. Study framework or philosophical orientation

a. If a framework was used, are its major concepts reflected in the questions asked during data

collection and in the findings?

b. If a framework was developed from the findings (grounded theory study), is it clearly

linked to the study findings?

4. Was the philosophical orientation of the qualitative approach identified? Was a primary source

for the philosophy cited (Grove et al., 2013; Munhall, 2012)?

5. Research objectives or questions

a. Are the objectives or questions presented clearly?

b. Are the objectives or questions linked to the research purpose?

6. Qualitative approach

a. Did the researchers select a qualitative approach that produced data to meet the objectives

or answer the research questions?

b. For a study with no identified qualitative approach, did the researcher provide a rationale

for why a qualitative study was conducted (Creswell, 2014; Grove et al., 2013)?

7. Sample and setting

a. Did the sampling method yield participants who had experience with the topic of the study

and could provide data to address the research questions?

b. Were participants excluded from the study because of age, socioeconomic status, or eth-

nicity without a sound rationale?

c. Were the rights of human subjects protected?

d. If potential participants refused to participate or participants did not complete the study,

did the researcher acknowledge these issues as limitations?

e. Did the setting in which data were collected protect the confidentiality and promote the

comfort of the participants?

f. If participants became upset during data collection, describe the measures taken to provide

them with emotional support (Cowles, 1988).

8. Data collection

a. Were questions used during the interview or focus group relevant to the study’s research

objectives or questions (Grove et al., 2013; Maxwell, 2013)?

b. Did the interviews last long enough for the researcher to gather robust, thorough descrip-

tions of the participants’ perspectives?

c. If focus groups were conducted, were the size, composition, and length adequate to pro-

mote group interaction and to produce robust data?

d. Were observations conducted at times and for long enough periods to collect rich data

that allows for a thorough description of the culture, setting, or process of interest

(Wolf, 2012)?

9. Data analysis

a. Were the data analysis processes described thoroughly enough to be able to evaluate the

logic of the researcher’s decisions and support the rigor of the study?

b. Were the measures to increase the trustworthiness of the study adequate to give the reader

confidence in the findings (Cohen & Crabtree, 2008; Mackey, 2012; Wolf, 2012)?

10. Interpretation of findings

a. Were the findings linked to quotes or specific observations?

b. Did the researcher address variations in the findings by relevant sample characteristics?

393CHAPTER 12 Critical Appraisal for Nursing Practice

c. If the findings were unexpected, what explanations were given for why this may have

occurred?

11. Limitations

a. Did the researchers acknowledge the limitations and their potential effects on the findings?

Were there limitations that the researchers did not acknowledge?

b. Were the limitations the result of factors under the researcher’s control or external factors

over which the researcher had no control?

12. Conclusions

a. Did the conclusions logically flow out of the findings?

b. Did the recommendations for future studies flow out of the findings?

c. Did the researchers identify other settings or participants to whom the findings might be

applicable?

Step 3: Evaluating the Trustworthiness and Meaning of Study Findings The final step in the critical appraisal of qualitative studies is based on the information that you

have identified and the conclusions that can be made from the first two steps of the process. Eval-

uating the trustworthiness of a study involves determining the credibility, transferability, depend-

ability, and confirmability of the study findings. Although these terms can be defined individually,

strategies used by the researchers to enhance the dependability of the findings directly affects the

credibility and confirmability of the findings. Similarly, the findings are transferable (applicable)

when the sample is described thoroughly, and the reader has confidence in the credibility, depend-

ability, and confirmability of the findings.

Guidelines for Evaluating the Trustworthiness and Meaning of Study Findings 1. Could the limitations of the study have been prevented?

2. Do the findings provide a credible reflection of reality?

3. Does the study expand nurses’ understanding of the phenomenon studied? If so, how can the

findings be used in nursing practice and education?

4. What do the findings add to the current body of knowledge related to theory and education?

5. How does this study support future knowledge development?

6. Did the overall presentation of the study fit its purpose, method, and findings?

7. Was the presentation logical and clearly written (Cohen & Crabtree, 2008)?

8. Did the researchers provide ideas for further research?

9. State the conclusion or summary of the critical appraisal of the study (Grove et al., 2013).

EXAMPLE OF A CRITICAL APPRAISAL OF A QUALITATIVE STUDY

Bultas (2012) conducted a qualitative study about the experiences of preschool children with

autism when they visit healthcare providers. A critical appraisal of the study was done to demon-

strate the application of the critical appraisal guidelines to a published qualitative study. A copy of

the study is provided here so that you may read it and work through the critical appraisal yourself.

The study is followed by the three steps of critical appraisal.

394 CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE

Example Qualitative Study

Continued

RESEARCH EXAMPLE—cont’d

396 CHAPTER 12 Critical Appraisal for Nursing Practice

Continued

397CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

398 CHAPTER 12 Critical Appraisal for Nursing Practice

Continued

399CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

400 CHAPTER 12 Critical Appraisal for Nursing Practice

Continued

401CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

402 CHAPTER 12 Critical Appraisal for Nursing Practice

Continued

403CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

404 CHAPTER 12 Critical Appraisal for Nursing Practice

Critical Appraisal

Step 1: Identifying the Components of the Qualitative Research Process 1. Introduction

• Qualifications of the researcher: Dr. Bultas is a certified pediatric nurse practitioner. Her PhD degree was

earned in 2010, and her dissertation was called “The Mother’s Perspective: Understanding More About

the Healthcare Experiences of the Preschool Child with Autism” (Bultas, 2010). She did not indicate in this

article any potential bias or personal connection to the topic of autism. The St. Louis University website

has a record of her scholarly work, which includes seven peer-reviewed publications on topics related to pedi-

atric nursing (http://www.slu.edu/Documents/nursing/Bultas13.pdf).

• Article title: The title indicates that the article is about the healthcare experiences of younger children with

autism, but does not indicate the type of qualitative approach that was used. The title does not indicate that

data were collected from the mothers of autistic children and not the children themselves. Because collecting

data from parents and other caregivers was probably the only feasible means of exploring the healthcare

needs of autistic children, a more appropriate title would be “Mothers’ Perspectives on Healthcare Visits

of Their Preschool Children with Autism: An Interpretive Phenomenological Study.”

• Abstract: The abstract did include the qualitative approach in the purpose statement. The sample size and data

collection methods were not identified. The two major themes and primary conclusion of the study comprised

the remainder of the five-sentence abstract.

2. Problem

• Significance: The section of the article called “Significance” included the justification for obtaining data from

the mothers instead of the fathers or both parents. Mothers were identified as the parent who most frequently

take children to healthcare visits. These preschool children frequently needed to see a healthcare provider

(HCP). The actual significance of the study was found in the review of the literature section.

“Most recent epidemiological studies now estimate the prevalence [autism] to be 1 in 110 children, an increase

in prevalence of approximately 57% (Centers for Disease Control and Prevention, 2009).. . .The statistics for

ASDs [autism spectrum disorders] is frightening to all parents, affected or not by this disorder. Of an even big-

ger concern is that there continues to be no validated medical treatment for ASDs.” (Bultas, 2012, p. 461)

• Background: The background of the problem included the history of when autism was first described and how

autism is typically diagnosed via screening tools administered by the child’s primary healthcare provider.

Autism is more prevalent in boys. Genes and unknown biological and environmental triggers were mentioned

as possible causes of autism. Additional background information was provided on the complex and unique

healthcare needs of children and families affected by autism (Bultas, 2012). Continued

(From Bultas, M. W. (2012). The health care experiences of the preschool child with autism. Journal of Pediatric Nursing, 27(5), 460–470.)

405CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

“One of the difficulties in treating comorbidities, in children with autism, is that the child’s biological response

to usual medical treatments and therapies for these conditions is frequently unpredictable (Volkmar,

Wiesnar, & Westphal, 2006).. . .Children with ASD have reactions in the environment that are not typical

and neither are their reactions to medical treatments. . ..The family of a child who has a disability has signif-

icant needs.” (Bultas, 2012, p. 461)

“One of the concerns that mothers have with their HCPs is the perception that providers are not always

listening or taking their concerns seriously.. . .Professional experience often demonstrates to HCPs that sim-

ple reassurance to parents is often all that is necessary. However, parents frequently have important

concerns and even a ‘sixth sense’ that something may not be right. . . . Families often desire more

information that is specific and individual to their child’s condition, which can be difficult given the wide range

of associated behaviors and the range of disability inherent in the diagnosis of autism.” (Bultas, 2012, p. 462)

• Problem statement:

“There is a lack of information regarding these mothers’ specific needs and concerns related to their chil-

dren’s healthcare experiences” (Bultas, 2012, p. 460).

3. Purpose

“The purpose of this interpretive phenomenological study was to gain a better understanding of mothers’

experiences when they take their preschool-age child with ASD to the HCP.” (Bultas, 2012, p. 462)

4. Literature Review

The literature review was clearly marked with a major heading. Of the 45 sources cited in the paper, Bultas (2012)

cited 15 of them to support statements that provided information and background on autism. Five references were

cited related to the method of interpretive phenomenology. Four government sources were cited with prevalence

rates, documenting the significance of the ASDs. Ten research papers reported analyses conducted with large data-

bases created by insurance companies or government entities. Researchers who collected original data related to the

healthcare of autistic and developmentally challenged children were cited 11 times. The studies were predominantly

quantitative, although a few qualitative studies were referenced. Bultas (2012) reviewed literature from government,

pediatrics, psychiatry, social science, and child development sources. Bultas (2012) cited the first professional pub-

lication identifying autism (Kanner, 1943), an example of a classic article that was appropriate to include, despite its

age. Four other sources were older than 1995. The remaining references included five from 2000 to 2004 and 35

references published in or since 2005. The article reports part of the data collected by Bultas for her dissertation,

which she completed in 2010. It does not appear that she updated her literature review between completing her

dissertation and publishing the article. She did not note strengths or weaknesses of the studies that she reviewed.

5. Study Framework or Philosophical Orientation of the Study

The philosophical orientation of the study was interpretive phenomenology. As support for this qualitative

approach, Bultas (2012) cited a book by Benner (1994) on interpretive phenomenology and a chapter in the book

by Leonard (1994). Although Dr. Benner is the nurse expert on interpretative phenomenology, Bultas (2012) did not

cite Heidegger, the originator of interpretive phenomenology.

6. Objectives (Aims) or Research Questions

“Specific aims of this study included the following:

1. Revealing the mothers’ concerns and feelings related to the healthcare experiences and needs of their

preschool-age child with ASD.

2. Examining resources and barriers that mothers experience when taking their child to the HCP and how

these affect the visit and the outcome of the visit.

3. Describing, from the mothers’ perspective, the behaviors of the preschool child with ASD during health-

care visits.” (Bultas, 2012, pp. 461-462)

406 CHAPTER 12 Critical Appraisal for Nursing Practice

7. Qualitative Approach

Interpretive phenomenology was the philosophical orientation and qualitative approach for the study.

8. Sample and Setting

• Inclusion and exclusion criteria: The inclusion criteria for the study

“required that mothers have primary caregiving responsibilities for their child, their child had received a diag-

nosis of ASD from a medical provider, the child was between the ages of 36 months and 72 months and not

enrolled in kindergarten, and the mothers were English speaking.” (Bultas, 2012, p. 463).

Exclusion criteria were not mentioned in the article.

• Sample: Eleven mothers who participated were 28 to 44 years old. Racial-ethnic diversity of the group was

limited with nine whites and two participants who reported being African American or Hispanic. Four mothers

had household incomes more than $100,000, with the rest reporting that their income was between $20,000

and $60,000 per year. The children were primarily sons (n¼10). The mothers were all “married to the child’s father and living as a family at the time” (Bultas, 2012. P. 464).

• Recruitment and human subjects protection: Bultas (2012, p. 463) recruited participants through a “parent

resource and advocacy group for families with a child with ASD” by sending a recruitment flyer through an elec-

tronic “list-serve and communication alerts.” The study and its recruitment plans and data collection procedures

were approved by an IRB prior to recruitment. Initial contact was made by telephone to screen potential partic-

ipants and ensure that they met the inclusion criteria. The researcher met the mothers for interviews in a local

coffeeshop orthe participants’ homes,withthe participants selecting their preferred location. The settings were

appropriate because the motherswerecomfortableintheirchosenlocation.Informedconsentwasobtainedand

documented during the first meeting. No information was provided about whether any mothers refused to par-

ticipate or about response plans in case mothers became upset during the interviews. Bultas (2012) conducted

three interviews with each mother and made no mention of any mothers who did not participate in all three

interviews.

9. Data Collection Procedures

Semistructuredinterviewswerethe methodofdatacollectionand followed a researcher-developedinterview guide.The

interview guide was not included in the article, so the interview questions cannot be compared to the study aims. With

each of the 33 interviews (three per each participant) lasting from 1 to 2 hours, the researcher collected a substantial

amount of data. To understand the mothers’ experiences better, Bultas (2012) requested that each mother complete a

child behavior checklist as well as the demographic questionnaire. “All interviews were digitally recorded and tran-

scribed by a transcriptionist” (Bultas, 2012, p. 463). No mention was made of field notes or journal entries.

10. Data Analysis Process

Digital recordings were professionally transcribed prior to analysis by Bultas (2012). Immersion in the data was

accomplished by reading the transcripts “several times each, and highlighted for significant information as they were

compared and contrasted to each other” (Bultas, 2012, p. 463). An audit trail was created by entering themes into a

table based on the researcher’s “background, previous experience, and prior knowledge” (Bultas, 2012, p. 464). A

paradigm case, defined as a participant with a particularly rich experience, was identified and analyzed first.

A researcher experienced in interpretive phenomenology and two other doctoral students analyzed significant

portions of the transcripts independently prior to meeting for three interpretive sessions. Using the methods

described, the interpretation of the data was verified.

• Trustworthiness of the findings: Bultas (2012) included a section in the article in which she described mea-

sures taken to evaluate the trustworthiness of the study. She identified aspects of the data collection and

analysis that supported credibility, confirmability, transferability, and dependability, which are the four criteria

of quality proposed by Lincoln and Guba (1985). Repeated interviews allowed the participants to verify

previous data that were collected and provided them with the opportunity to add information to previous

interview data, an example of member checking. The number and length of interviews, use of a paradigm

case, identification of the researcher’s perspectives on the topic, and interpretive sessions were described

as measures taken to ensure the trustworthiness of the study and its findings. Continued

407CHAPTER 12 Critical Appraisal for Nursing Practice

RESEARCH EXAMPLE—cont’d

11. Interpretation of Findings

In the review of the literature, Bultas (2012) described parental concerns that providers were unaware of the impact

of autism on the family and failed to acknowledge or address the concerns of parents in a respectful way. The same

concerns were revealed in the data analysis, as indicated by the themes of “they just don’t ‘get it’” and “marginalized

by those who should care” (Bultas, 2012, pp. 465-466). Providers did not recognize the extensive knowledge that

mothers of children with autism have of their children. They also did not recognize the “emotional toll of autism on

the family” (p. 465). If they chose to seek alternative treatments, mothers indicated that they wanted support and

information from providers. The findings were consistent with the limited findings that had been previously pub-

lished. One unexpected finding was the mothers’ desire for healthcare providers to be supportive and informative

about the use of complementary and alternative therapies.

12. Limitations

Bultas (2012) acknowledged the limitations of a small sample size, participants being asked to recall previous expe-

riences, and participants not disclosing pertinent information. With each limitation, she reiterated the strategies

used to minimize the limitations, such as conducting multiple interviews with each mother, meeting with partic-

ipants over several weeks, and developing a relationship with the mothers.

13. Conclusions

Bultas (2012) emphasized in the conclusions the importance of the findings in light of the increased prevalence of

autism and unique needs of families affected by autism.

“HCPs will be interfacing and caring for an increased number of children with ASD. The unique needs and

approach necessary in caring for children with ASD can complicate the delivery of healthcare services.

Mothers are an important resource for their child’s HCP. Taking the time to understand the effects of

ASD on the entire family, acknowledging the mother’s expertise regarding her child, and acting on her con-

cerns can reduce barriers to quality care.” (Bultas, 2012, p. 468)

14. Transferability of the Findings

The mothers identified the need for waiting and examination rooms to have developmentally appropriate toys,

along with sanitizing wipes or hand cleanser to minimize the risk of infection. “Mothers felt this was as important

for the typically developing child as it was for their child with autism” (Bultas, 2012, p. 468). Although not stated by

Bultas (2012), the recommendation to develop a child profile is transferable to any child with special needs seeking

care in an HCP’s office. The child profile will contain information to remind HCPs of ways to remove barriers for

care and increase the effectiveness of the communication between the HCPs and mothers.

15. Implications for Nursing Practice

In addition to the mothers’ recommendation related to a child profile and having toys available, they also identified

that written instructions needed to be sent home with the mothers to provide information they need to care for their

children at home (Bultas, 2012). The mothers also recommended that a reinforcement given at the end of the visit by

many HCPs, such as a sticker or small toy, should be continued. The overall nursing implication of the study finding

is to listen to mothers and other caregivers, because they know their family members better than HCPs can know

them (Bultas, 2012). HCPs can meet the patient’s unique needs by partnering with and learning from mothers and

others who provide routine care to the patient at home.

16. Future studies

Bultas (2012) noted that research is needed to test the use of a child profile and evaluate the care that families affected

by autism receive in the context of the medical home model.

Step 2: Determining Study Strengths and Weaknesses Research Problem, Purpose, and Objectives

The problem of providing effective care for children with autism is a significant problem because of the prevalence

of the condition and the challenges of meeting the unique healthcare needs of the families affected by autism.

408 CHAPTER 12 Critical Appraisal for Nursing Practice

The purpose was clear and stated the study’s focus. The research objectives were clear and linked to the study pur-

pose (Fawcett & Garity, 2009; Maxwell, 2013).

Review of the Literature

The multidisciplinary review was well organized. The references cited supported the need for the study and appro-

priateness of the study’s methods. Although little information was provided about the quality of the studies

reviewed, the findings of previous studies and information from other references were synthesized and compared

to each other. The gap in knowledge addressed by the study was clearly identified.

Philosophical Orientation and Qualitative Approach

Interpretive phenomenology was the philosophical basis for the study. No primary source was provided; however,

Dr. Benner (1994) was cited as the authority who developed the specific type of phenomenology used by Bultas

(2012). Providing information from Heidegger and citing a primary source would have strengthened the description

of the qualitative approach. The qualitative approach was congruent with the study purpose and objectives.

Sample and Setting

The participants had experience with the research topic and were valuable sources of data. The inclusion criterion

that mothers had to speak English may have limited participation of some mothers. The rights of human subjects

were protected through the recruiting and data collection phases of the study. Informed consent was obtained prior

to data collection. The protection of the participants was also enhanced by allowing them to select the setting for the

interviews. Bultas (2012) did not provide information about potential participants who were approached about

the study but did not participate. She also did not note whether arrangements were made in advance to address

the emotional needs of the participants in case the topic was upsetting to them (Cowles, 1988).

Data Collection

Repeated interviews were conducted to address the research objectives. The interviews lasted between 1 and 2 hours,

and each participant was interviewed three times. The total time spent with each participant, a strength of the study,

was more than enough to develop robust responses to the research questions. The specific questions used during the

interview were not included in the article. The findings produced from the interviews related to the objectives of the

study, so one can infer that the interview questions were relevant (Maxwell, 2013).

Data Analysis

Bultas (2012) provided a thorough description of the data analysis, beginning with immersion in the data following

transcription of the interviews. She used several strategies to structure the review process, including identifying a

paradigm case for comparison to each subsequent interview and completing a table of themes related to each study

aim.

“During the process of reading and rereading the transcripts, key information was transferred to the large

table under the appropriate specific aim heading. After the table was completed and all interviews had been

read and analyzed, the table was reviewed, which further highlighted and made apparent the themes and

subthemes.” (Bultas, 2012, p. 464)

She also provided a thorough description of the interpretive sessions that were part of the data analysis. These

sessions were valuable to the researcher at the time but also to the reader, because using them supported the trust-

worthiness of the study. In addition, the trustworthiness of the study was directly addressed in a section of the paper

titled “Validity and Trustworthiness of the Data” (Bultas, 2012, p. 464). The use of multiple strategies to enhance

trustworthiness increases the reader’s confidence in the findings (Cohen & Crabtree, 2008; Murphy & Yielder, 2010).

The support provided for the trustworthiness of the study is a major strength of the article.

Interpretation of Findings

Bultas (2012) provided quotes to support each theme and subtheme. She did not address variations in findings

based on sample characteristics. The sample was homogeneous because of limiting the study to a particular age

group of children and narrowly defining the research problem as the lack of knowledge related to the healthcare Continued

409CHAPTER 12 Critical Appraisal for Nursing Practice

K E Y C O N C E P T S

• An intellectual critical appraisal of research requires careful examination of all aspects of a study

to judge its strengths, weaknesses, credibility, meaning, and significance.

• Research is critically appraised to broaden understanding, improve practice, and provide a

background for conducting a study.

• All nurses, including students, practicing nurses, nurse educators, and nurse researchers, need

expertise in the critical appraisal of research.

• The research critical appraisal process includes identifying the steps of the research process in

studies, determining study strengths and weaknesses, and evaluating the credibility and mean-

ing of study findings.

• Strong quantitative study is guided by a clear, concise problem and purpose and appropriate

objectives, questions, or hypotheses. The study framework is appropriate; the design is relevant,

with limited threats to validity; data analyses address the study objective, questions, or hypoth-

eses; and the study findings are credible and an accurate reflection of reality.

• Critical appraisals of qualitative studies include identifying the components of the qualitative

research process, determining study strengths and weaknesses, and evaluating the trustworthi-

ness and meaning of the study findings.

RESEARCH EXAMPLE—cont’d

visit. The unexpected findings related to wanting to discuss complementary and alternative therapies were not

explained and were not mentioned in the literature review.

Limitations

The acknowledged limitations of the study were minimized to the extent possible by the researcher’s well-designed

study. One limitation—the few children who had healthcare visits during the study—was not under the control of

the researcher.

Conclusions

The conclusions and recommendations for future studies were logically congruent with the findings. Bultas (2012)

recommended conducting a study to evaluate the use of a child profile, a potential intervention that was identified in

the data.

Step 3: Evaluating the Trustworthiness and Meaning of Study Findings Bultas (2012) conducted a well-designed study that minimized the limitations to a great degree. As a result, the

findings provide a credible view of the healthcare needs of children with autism from the perspective of their

mothers. The findings can be used in nursing practice as support for creating a child profile that the provider

and mother of a child with autism can develop collaboratively. Mothers’ suggestions related to the toys needed

in the waiting room and scheduling of visits would be appropriate for children with autism, as well as for other

children with developmental needs. In nursing education, these strategies can be shared as part of a pediatric nursing

course. Including the findings in an update for pediatric nurses would be appropriate for continuing nursing edu-

cation. The findings of this study expand current EBP knowledge and can be used to provide patient-centered care to

mothers and their children with autism. This type of knowledge promotes the accomplishment of the QSEN (2013)

competencies for prelicensure nursing students. Bultas (2012) noted that the findings could be used to support test-

ing a child profile as an intervention for children with developmental needs.

The congruence of the purpose, method, and findings was clearly demonstrated throughout the presentation of

the study. The article was organized and clearly written. The study’s strengths exceed its few weaknesses, and it can

serve as a strong example of interpretive phenomenology.

410 CHAPTER 12 Critical Appraisal for Nursing Practice

• Strong qualitative studies are based on a philosophical orientation and qualitative approach

that are specified. Building on that foundation, the researcher implements data collection

and analysis methods that enhance the study’s trustworthiness.

• Detailed guidelines are provided for conducting critical appraisals of quantitative and qualita-

tive studies.

• Example critical appraisals are provided for a quantitative study and a qualitative study.

REFERENCES

Aberson, C. L. (2010). Applied power analysis for the

behavioral sciences. New York: Routledge Taylor &

Francis.

Agency for Healthcare Research and Quality (AHRQ).

(2013). AHRQ home. Retrieved February 19, 2013

from, http://www.ahrq.gov.

Alligood, M. R. (2010). Nursing theory: Utilization &

application. Maryland Heights, MO: Mosby

Elsevier.

American Nurses Credentialing Center (ANCC). (2013).

Magnet program overview. Retrieved February 18, 2013

from, http://www.nursecredentialing.org/Magnet/

ProgramOverview.aspx.

American Psychological Association (APA). (2010).

Publication manual of the American Psychological

Association (6th ed.). Washington, DC: Author.

Armstrong, D. J., Meenagh, G. K., Bickle, I., Lee, A. S. H.,

Curran, S., & Finch, M. B. (2007). Vitamin D deficiency

is associated with anxiety and depression in

fibromyalgia. Clinical Rheumatology, 26(4),

551–554.

Benner, P. (1994). Interpretive phenomenology:

Embodiment, caring, and ethics in health and illness.

Thousand Oaks, CA: Sage Publications.

Berk, M., Sanders, K. M., Pasco, J. A., Jacka, F. N.,

Williams, L. J., Hayles, A. L., et al. (2007). Vitamin D

deficiency may play a role in depression. Medical

Hypotheses, 69(6), 1316–1319.

Bialocerkowski, A., Klupp, N., & Bragge, P. (2010).

Research methodology series: How to read and

critically appraise a reliability article. International

Journal of Therapy and Rehabilitation, 17(3), 114–120.

Brown, S. J. (2002). Focus on research methods. Nursing

intervention studies: A descriptive analysis of issues

important to clinicians. Research in Nursing & Health,

25(4), 317–327.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Bultas, M. W. (2010). The mother’s perspective:

Understanding more about health care experiences

of the preschool child with autism. University of

Missouri—St. Louis, ProQuest, UMI Dissertations

Publishing, 3427619.

Bultas, M. W. (2012). The health care experiences of the

preschool child with autism. Journal of Pediatric

Nursing, 27(5), 460–470.

Burns, N. (1989). Standards for qualitative research.

Nursing Science Quarterly, 2(1), 44–52.

Centers for Disease Control and Prevention. (2009).

Prevalence of autism spectrum disorders—Autism and

developmental disabilities monitoring network,

United States, 2006. MMWR Surveillance Summaries,

58(SS 10), 1–20.

Chinn, P. L., & Kramer, M. K. (2011). Integrated theory and

knowledge development in nursing (8th ed.). St. Louis:

Elsevier Mosby.

Clissett, P. (2008). Evaluating qualitative research. Journal

of Orthopaedic Nursing, 12(2), 99–105.

Cohen, D. J., & Crabtree, B. F. (2008). Evaluative criteria

for qualitative research in health care: Controversies

and recommendations. Annals of Family Medicine,

6(4), 331–339.

Cowles, K. (1988). Issues in qualitative research on

sensitive topics. Western Journal of Nursing Research,

10(2), 163–179.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh: Churchill

Livingstone Elsevier.

Creswell, J. W. (2013). Qualitative inquiry & research

design: Choosing among five approaches (3rd ed.).

Thousand Oaks, CA: Sage.

Creswell, J. W. (2014). Research design: Qualitative,

quantitative and mixed methods approaches (3rd ed.).

Thousand Oaks, CA: Sage.

DeKeyser, F. G., & Pugh, L. C. (1990). Assessment of

reliability and validity of biochemical measures.

Nursing Research, 39(5), 314–317.

DeVon, H. A., Block, M. E., Moyle-Wright, P., Ernst, D. M.,

Hayden, S. J., et al. (2007). A psychometric toolbox for

testing validity and reliability. Journal of Nursing

Scholarship, 39(2), 155–164.

411CHAPTER 12 Critical Appraisal for Nursing Practice

Doran, D. M. (2011). Nursing outcomes: The state of the

science (2nd ed.). Canada: Jones & Bartlett Learning.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia: F. A. Davis.

Gaines, S. (2005). The saddest season. Minnesota Medicine,

88(11), 30–33.

Gloeckner, M. B., & Robinson, C. B. (2010). A nursing

journal club thrives through shared governance.

Journal for Nurses in Staff Development, 26(6), 267–270.

Grove, S. K. (2007). Statistics for health care research: A

practical workbook. St. Louis: Saunders Elsevier.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). St. Louis: Elsevier Saunders.

Hart, C. (2009). Doing a literature review: Releasing the

social science imagination. Thousand Oaks, CA: Sage

Publications.

Hoare, Z., & Hoe, J. (2013). Understanding quantitative

research: Part 2. Nursing Standard (Royal College of

Nursing [Great Britain]), 27(18), 48–55.

Hoe, J., & Hoare, Z. (2012). Understanding quantitative

research: Part 1. Nursing Standard (Royal College of

Nursing [Great Britain]), 27(15-17), 52–57.

Holick, M., & Jenkins, M. (2003). The UVadvantage. New

York: Ibooks.

Jorde, R., Waterloo, K., Salech, F., Haug, E., & Svartberg, J.

(2006). Neuropsychological function in relation to

serum parathyroid hormone and serum 25-

hydroxyvitamin D levels: The Tromso study. Journal of

Neurology, 253(4), 464–470.

Kanner, L. (1943). Autistic disturbances of affective

contact. Nervous Child, 2, 217–250.

Kiraly, S., Kiraly, M., Hawe, R., & Makhami, N. (2006,

January). Vitamin D as a neuroactive substance:

Review. Scientific World Journal, 6, 125–139.

Leonard, V. W. (1994). A Heideggerian phenomenological

perspective on the concept of person. In P. Benner

(Ed.), Interpretive phenomenology: Embodiment, caring,

and ethics in health and illness (pp. 43–64). Thousand

Oaks, CA: Sage Publications.

Lincoln, Y. S., & Guba, E. G. (1985). Naturalistic inquiry.

Thousand Oaks, CA: Sage Publications.

Mackey, M. (2012). Evaluation of qualitative research. In

P. L. Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 517–531). (5th ed.). Sudbury, MA:

Jones & Bartlett.

Maxwell, J. (2013). Qualitative research design: An

interactive approach (3rd ed.). Thousand Oaks, CA:

Sage Publications.

Melnyk, B. M., & Fineout-Overholt, E. (Eds.). (2011).

Evidence-based practice in nursing & healthcare: A guide

to best practice. (2nd ed.). Philadelphia: Lippincott,

Williams, & Wilkins.

Miles, M., Huberman, A., & Saldana, J. (2014). Qualitative

data analysis: A methods sourcebook (3rd ed.).

Thousand Oaks, CA: Sage Publications.

Mittlbock, M. (2008). Critical appraisal of randomized

clinical trials: Can we have faith in the conclusions?

Breast Care, 3(5), 341–346.

Morrison, D. M., Hoppe, M. J., Gillmore, M. R., Kluver, C.,

Higa, D., & Wells, E. A. (2009). Replicating an

intervention: The tension between fidelity and

adaptation. AIDS Education and Prevention, 21(2),

128–140.

Morse, J. M. (1991). Evaluating qualitative research.

Qualitative Health Research, 1(3), 283–286.

Munhall, P. L. (2012). Nursing research: A qualitative

perspective (5th ed.). Sudbury, MA: Jones & Bartlett.

Murphy, F., & Yielder, J. (2010). Establishing rigor

in qualitative radiography. Radiography, 16(1),

62–67.

National Institute of Nursing Research (NINR). (2013).

What is nursing research? Retrieved February 18, 2013

from, https://www.ninr.nih.gov.

O’Mathuna, D. P., Fineout-Overholt, E., & Johnston, L.

(2011). Critically appraising quantitative evidence for

clinical decision making. In B. M. Melnyk, &

E. Fineout-Overholt (Eds.), Evidence-based practice

in nursing & healthcare: A guide to best practice

(pp. 81–134) (2nd ed.). Philadelphia: Lippincott Wil-

liams & Wilkins.

Obradovic, D., Gronemeyer, H., Lutz, B., & Rein, T.

(2006). Cross-talk of vitamin D and glucocorticoids in

hippocampal cells. Journal of Neurochemistry, 96(2),

500–509.

Petty, N., Thomson, O., & Stew, G. (2012). Ready for a

paradigm shift? Part 2: Introducing qualitative research

methodologies and methods. Manual Therapy, 17(5),

378–384.

Pickler, R. H. (2007). Evaluating qualitative research

studies. Journal of Pediatric Health Care, 21(3),

195–197.

Plichta, S. B., & Kelvin, E. (2013). Munro’s statistical

methods for health care research (6th ed.). Philadelphia:

Lippincott Williams & Wilkins.

Pyrczak, F. (2008). Evaluating research in academic

journals: A practical guide to realistic evaluation (4th

ed.). Los Angeles: Pyrczak.

Quality and Safety Education for Nurses (QSEN). (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved February 11, 2013 from, http://qsen.org/

competencies/pre-licensure-ksas.

412 CHAPTER 12 Critical Appraisal for Nursing Practice

Roberts, W. D., & Stone, P. W. (2003). Ask an expert: How

to choose and evaluate a research instrument. Applied

Nursing Research, 16(1), 70–72.

Ryan-Wenger, N. A. (2010). Evaluation of measurement

precision, accuracy, and error in biophysical data for

clinical research and practice. In C. F. Waltz, O. L.

Strickland, & E. R. Lenz (Eds.), Measurement in nursing

and health research (pp. 371–383). (4th ed.). New York:

Springer.

Sandelowski, M. (2008). Justifiying qualitative research.

Research in Nursing & Health, 31(3), 193–195.

Sandelowski, M., & Barroso, J. (2007). Handbook

for synthesizing qualitative research. New York:

Springer.

Santacroce, S. J., Maccarelli, L. M., & Grey, M. (2004).

Methods: Intervention fidelity. Nursing Research, 53(1),

63–66.

Schoe, L., H�strup, H., Lyngs�, E., Larsen, S., & Poulsen, I. (2011). Validation of a new assessment tool for

qualitative research articles. Journal of Advanced

Nursing, 68(9), 2086–2094.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002).

Experimental and quasi-experimental designs

for generalized causal inference. Chicago: Rand

McNally.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Shipowick, C. D., Moore, C. B., Corbett, C., & Bindler, R.

(2009). Vitamin D and depressive symptoms in women

during the winter: A pilot study. Applied Nursing

Research, 22(3), 221–225.

Sloan, D. M., & Kornstein, S. G. (2003). Gender differences

in depression and response to antidepressant treatment.

Psychiatric Clinics of North America, 26(3), 581–594.

Smith, M. J., & Liehr, P. R. (2008). Middle range theory for

nursing (2nd ed.). New York: Springer.

Volkmar, F. R., Wiesner, L. A., & Westphal, A. (2006).

Healthcare issues for children on the autism spectrum.

Current Opinion in Psychiatry, 19(4), 361–366.

Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010).

Measurement in nursing and health research (4th ed.).

New York: Springer.

Wolf, M. (2012). Ethnography: The method. In P. L.

Munhall (Ed.), Nursing research: A qualitative

perspective (pp. 285–338) (5th ed.). Sudbury, MA:

Jones & Bartlett.

World Health Organization. (2000). Setting the WHO

agenda for mental health. Bulletin of the World Health

Organization, 78(4), 500.

413CHAPTER 12 Critical Appraisal for Nursing Practice

C H A P T E R

13 Building an Evidence-Based Nursing Practice

C H A P T E R OV E R V I E W

Benefits and Barriers Related to Evidence-Based

Nursing Practice, 416

Benefits of Evidence-Based Nursing Practice, 416

Barriers to Evidence-Based Nursing Practice, 418

Searching for Evidence-Based Sources, 419

Critically Appraising Research Syntheses, 421

Critically Appraising Systematic Reviews, 421

Critically Appraising Meta-Analyses, 430

Critically Appraising Meta-Syntheses, 436

Critically Appraising Mixed-Methods Systematic

Reviews, 440

Developing Clinical Questions to Identify

Existing Research-Based Evidence for Use

in Practice, 443

Models to Promote Evidence-Based Practice

in Nursing, 447

Stetler Model of Research Utilization to Facilitate

Evidence-Based Practice, 447

Iowa Model of Evidence-Based Practice, 450

Application of the Iowa Model

of Evidence-Based Practice, 450

Implementing Evidence-Based Guidelines

in Practice, 453

History of the Development of Evidence-Based

Guidelines, 454

National Guideline Clearinghouse

Resources, 454

Implementing Evidence-Based Guidelines for

Management of Hypertension in Practice, 456

Introduction to Evidence-Based Practice

Centers, 460

Introduction to Translational Research, 461

Key Concepts, 461

References, 463

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Identify the benefits and barriers related to

evidence-based practice in nursing.

2. Critically appraise systematic reviews,

meta-analyses, meta-syntheses, and mixed-

methods systematic reviews of current research

evidence.

3. Use the PICOS format to formulate clinical

questions to identify evidence for use in practice.

4. Describe the models used to promote evidence-

based practice in nursing.

5. Apply the Iowa Model of Evidence-Based

Practice for implementing evidence-based

changes in your practice.

6. Implement research-based protocols, algorithms,

and policies in your practice.

7. Apply the Grove Model to implement national

evidence-based guidelines in your practice.

8. Describe the significance of evidence-based

practice centers and translational research in

developing evidence-based health care.

414

K E Y T E R M S

Ancestry searches, p. 432

Best research evidence, p. 415

Citation bias, p. 433

Duplicate publication

bias, p. 433

Evidence-based

guidelines, p. 453

Evidence-based practice

(EBP), p. 415

Evidence-based practice centers

(EPCs), p. 460

Forest plot, p. 436

Funnel plot, p. 433

Grey literature, p. 424

Grove Model for Implementing

Evidence-Based Guidelines

in Practice, p. 456

Heterogeneity, p. 430

Iowa Model of Evidence-Based

Practice, p. 450

Language bias, p. 433

Location bias of studies, p. 433

Mean difference, p. 435

Meta-analysis, p. 430

Metasummary, p. 437

Meta-synthesis, p. 437

Methodological bias, p. 433

Mixed-methods systematic

review, p. 441

Multilevel synthesis, p. 441

Parallel synthesis, p. 441

Odds ratio (OR), p. 435

Outcome reporting bias, p. 433

PICO format, p. 443

PICOS format, p. 423

Publication bias, p. 433

Research-based protocols, p. 450

Risk difference (RD), p. 436

Risk ratio (RR) or relative

risk, p. 435

Standardized mean difference

(SMD), p. 435

Stetler Model of Research

Utilization to Facilitate

Evidence-Based

Practice, p. 447

Phase I: Preparation, p. 448

Phase II: Validation, p. 448

Phase III: Comparative

Evaluation/Decision

Making, p. 448

Phase IV: Translation/

Application, p. 449

Phase V: Evaluation, p. 449

Systematic review, p. 421

Time lag bias of studies, p. 433

Translational research, p. 461

Research evidence has greatly expanded over the last 30 years as numerous quality studies in nurs-

ing, medicine, and other healthcare disciplines have been conducted and disseminated. These

studies are commonly communicated via conferences, journals, and the Internet. The expectations

of society and the goals of healthcare systems are the delivery of quality, safe, cost-effective health

care to patients, families, and communities, nationally and internationally. To ensure the delivery

of quality health care, the care must be based on the current best research evidence available.

Healthcare agencies are emphasizing the delivery of evidence-based health care, and nurses and

physicians are focused on evidence-based practice (EBP). With the emphasis on EBP over the last

2 decades, outcomes have improved for patients, healthcare providers, and healthcare agencies

(Brown, 2014; Craig & Smyth, 2012; Doran, 2011; Higgins & Green, 2008; Melnyk & Fineout-

Overholt, 2011).

Evidence-based practice (EBP) is an important theme in this text that was defined in Chapter 1

as the conscientious integration of best research evidence with clinical expertise and patient values

and needs in the delivery of quality, safe, cost-effective health care (Craig & Smyth, 2012; Institute

of Medicine, 2001; Sackett, Straus, Richardson, Rosenberg, & Haynes, 2000). Best research evi-

dence is produced by the conduct and synthesis of numerous high-quality studies in a selected

health-related area. The concept of best research evidence was described in Chapter 1, and the pro-

cesses for synthesizing research evidence (systematic review, meta-analysis, meta-synthesis, and

mixed-methods systematic review) were defined.

This chapter builds on previous EBP discussions in this text to provide you with strategies

for implementing the best research evidence in your practice and moving the profession of

nursing toward EBP. This chapter examines the benefits and barriers related to implementing

415CHAPTER 13 Building an Evidence-Based Nursing Practice

evidence-based care in nursing. Guidelines are provided for critically appraising research syntheses

(systematic reviews, meta-analyses, meta-syntheses, and mixed-methods systematic reviews) to

determine the knowledge that is ready for use in practice. Two nursing models developed to

facilitate EBP in healthcare agencies are introduced. Expert researchers, clinicians, and con-

sumers—through government agencies, professional organizations, and healthcare agencies—

have developed an extensive number of evidence-based guidelines. A framework for reviewing

the quality of these evidence-based guidelines and for using them in practice is provided. This

chapter concludes with a discussion of the nationally designated EBP centers and translational

research implemented to promote evidence-based health care.

BENEFITS AND BARRIERS RELATED TO EVIDENCE-BASED NURSING PRACTICE

EBP is a goal for the profession of nursing and each practicing nurse. At the present time, some

nursing interventions are evidence-based, or supported by the best research knowledge available

from systematic reviews, meta-analyses, meta-syntheses, and mixed-methods systematic reviews.

However, many nursing interventions require additional research to generate essential knowledge

for making changes in practice. Some nurses readily use research-based interventions, and others

are slower to make changes in their practice based on research. Some clinical agencies are support-

ive of EBP and provide resources to facilitate this process, but other agencies have limited support

for the EBP process. This section identifies some of the benefits and barriers related to EBP to assist

you in delivering evidence-based care to your patients.

Benefits of Evidence-Based Nursing Practice The greatest benefits of EBP are improved outcomes for patients, providers, and healthcare agen-

cies. Organizations and agencies nationally and internationally have promoted the synthesis of the

best research evidence in thousands of healthcare areas by teams of expert researchers and clini-

cians. These research syntheses, such as systematic reviews and meta-analyses, have provided the

basis for developing strong evidence-based guidelines for practice. These guidelines identify the

best treatment plan, or gold standard, for patient care in a selected area to promote quality health

outcomes. Students and clinical nurses have easy access to numerous evidence-based guidelines to

assist them in making the best clinical decisions for their patients. These evidence-based syntheses

and guidelines are found in presentations and publications and can be easily accessed online

through the National Guideline Clearinghouse (NGC, 2014a) in the United States (http://www.

guideline.gov/browse/by-topic.aspx), the Cochrane Collaboration (2014) in England (http://

www.cochrane.org/cochrane-reviews), and the Joanna Briggs Institute (2014) in Australia

(http://www.joannabriggs.org/index.html). Additional EBP resources are presented later in this

chapter.

Healthcare agencies are highly supportive of EBP because it promotes quality, cost-effective care

for patients and families and meets accreditation requirements. The Joint Commission (2014)

revised their accreditation criteria to emphasize patient care quality achieved through EBP.

Approximately 25% of chief nursing officers (CNOs) identified the movement toward

evidence-based nursing practice as their number one priority (Nurse Executive Center, 2005).

Many CNOs and healthcare agencies are trying to obtain or maintain Magnet status, which doc-

uments the excellence of nursing care in an agency. Approval for Magnet status is obtained through

the American Nurses Credentialing Center (ANCC). The national and international healthcare

agencies that currently have Magnet status can be viewed online at the ANCC (2014) website

(http://www.nursecredentialing.org/Magnet/FindaMagnetFacility.aspx). The Magnet Recognition

416 CHAPTER 13 Building an Evidence-Based Nursing Practice

Program recognizes EBP as a way to improve the quality of patient care and revitalize the nursing

environment. Selection criteria for Magnet status that require healthcare agencies to promote the

conduct of research and use of research evidence in practice follow.

Force 6: Quality Care “Research and Evidence-Based Practice

22. Describe how current literature, appropriate to the practice setting, is available, dissemi-

nated, and used to change administrative and clinical practices.

23. Discuss the institution’s policies and procedures that protect the rights of participants in

research protocols. Include evidence of consistent nursing involvement in the governing body

responsible for protection of human subjects in research.

24. Provide evidence that research consultants are actively involved in shaping nursing research

infrastructure, capacity, and mentorship.

25. Provide a copy of the nursing budget or other sources of funding for the past year, the cur-

rent year-to-date, and the future projection, highlighting the allocation and utilization of

resources for nursing research.

26. Supply documentation of all nursing research activities that are ongoing, including internal

validation studies, internal and external research, and participation in surveys completed within

the past twelve (12) month period.

27. Provide evidence of education and mentoring activities that have effectively engaged staff

nurses in research- and/or evidence-based practice activities.

28. Describe resources available to nursing staff to support participating in nursing research

and nursing research utilization activities.”

Nursing Executive Center, 2005, p. 15

These selection criteria include critical elements for EBP, especially financial support for and

outcomes related to research activities. Important research-related outcomes to be documented

by agencies for Magnet status include nursing studies conducted and professional publications

and presentations by nurses. For each study, the title of the study, principal investigator or inves-

tigators, role of nurses in the study, and study status need to be documented (Horstman &

Fanning, 2010).

The Quality and Safety Education for Nurses (QSEN, 2013) project was implemented to

improve prelicensure nurses’ “knowledge, skills, and attitudes (KSAs) that are necessary to con-

tinuously improve the quality and safety of the healthcare systems within which they work.” QSEN

competencies were developed in six areas essential for students and registered nurses’ (RNs)

practice—patient-centered care, teamwork and collaboration, EBP, quality improvement (QI),

safety, and informatics. QSEN competencies were introduced in Chapter 1 and are linked to study

findings in all chapters in this text. You can view the competencies on the QSEN Institute website

(http://qsen.org/competencies/pre-licensure-ksas). EBP is an important area in your prelicensure

education, and educators and students need to work toward achieving the following EBP

competencies:

“Participate effectively in appropriate data collection and other research activities.

Adhere to Institutional Review Board (IRB) guidelines.

Base individualized care plan on patient values, clinical expertise, and evidence.

Read original research and evidence reports related to area of practice.

Locate evidence reports related to clinical practice topics and guidelines.

417CHAPTER 13 Building an Evidence-Based Nursing Practice

Participate in structuring the work environment to facilitate integration of new evidence into

standards of practice.

Question rationale for routine approaches to care that result in less-than-desired outcomes or

adverse events.

Consult with clinical experts before deciding to deviate from evidence-based protocols.”

QSEN, 2013

Students and RNs demonstrating these EBP competencies are able to provide quality, safe care

to patients and to accomplish the goals outlined for Magnet status. Sherwood and Barnsteiner

(2012) provide details on the QSEN competencies and educational experiences to promote the

KSAs of prelicensure and graduate nurses. In working toward EBP, students and practicing nurses

are encouraged to embrace the benefits of EBP; critically appraise current research evidence; refine

agency protocols, algorithms or clinical decision trees, and policies based on current research; use

the evidence-based guidelines available; and collect data as needed for research projects.

Barriers to Evidence-Based Nursing Practice Barriers to the EBP movement have been practical and conceptual. One of the most serious barriers

is the lack of research evidence available regarding the effectiveness of many nursing interventions.

EBP requires synthesizing research evidence from randomized controlled trials (RCTs) and other

types of intervention studies, and these types of studies are still limited in nursing. Mantzoukas

(2009) reviewed the research evidence in 10 high-impact nursing journals, including Nursing

Research, Research in Nursing & Health, Western Journal of Nursing Research, Journal of Nursing

Scholarship, and Advances in Nursing Science, between 2000 and 2006 and found that the studies

were 7% experimental, 6% quasi-experimental, and 39% nonexperimental. However, RCTs and

quasi-experimental studies conducted to determine the effectiveness of nursing interventions

did increase during that time period.

Systematic reviews and meta-analyses conducted in nursing are limited when compared with

other disciplines, such as medicine and psychology. In addition, nurse authors of these research

syntheses have sometimes indicated that there is inadequate research evidence to support using

certain nursing interventions in practice (Craig & Smyth, 2012; Mantzoukas, 2009). Bolton,

Donaldson, Rutledge, Bennett, and Brown (2007, p. 123S) conducted a review of “systematic/

integrative reviews and meta-analyses on nursing interventions and patient outcomes in acute care

settings.” Their literature search covered 1999 to 2005 and identified 4000 systematic-integrative

reviews and 500 meta-analyses covering the following seven topics selected by the authors—

staffing, caregivers, incontinence, care of older adults, symptom management, pressure ulcer pre-

vention and treatment, and developmental care of neonates and infants. The authors found a

limited association between nursing interventions and processes and patient outcomes in acute

care settings, as indicated by the following:

“The strongest evidence was for the use of patient risk-assessment tools and interventions imple-

mented by nurses to prevent patient harm. We observed significant variation in the methods to

measure the effect of independent variables (nursing interventions) on patient outcomes. Results

indicate the need for more research measuring the effect of specific nursing interventions that

may impact acute care patient outcomes.”

Bolton et al., 2007, p. 123S

Extensive evidence has been generated through nursing research, but additional studies are

needed that focus on determining the effectiveness of nursing interventions on patient outcomes

418 CHAPTER 13 Building an Evidence-Based Nursing Practice

(Bolton et al., 2007; Doran, 2011; Mantzoukas, 2009). Identifying the areas in which research

evidence is lacking is an important first step in developing the evidence needed for practice.

Well-designed experimental and quasi-experimental studies are needed to test selected nursing

interventions and to use that understanding to generate sound evidence for practice. Nurses also

need to be more active in conducting quality syntheses (systematic reviews, meta-analyses, and

meta-syntheses) of research evidence in selected areas (Finfgeld-Connett, 2010; Higgins &

Green, 2008; Moore, 2012; Rew, 2011).

Another concern is that the research evidence is generated based on population data and then is

applied in practice to individual patients. Sometimes it is difficult to transfer research knowledge

to individual patients, who respond in unique ways or have unique needs. More work is needed to

promote the use of evidence-based guidelines with individual patients. The National Institutes of

Health (NIH, 2012) is supporting translational research to improve the use of research evidence

with different patient populations in various settings. Patients who have poor outcomes

when managed according to an evidence-based guideline need to be reported and, if possible,

their circumstances should be published as a case study. Electronic health records (EHRs) now

make it possible to determine patient outcomes of care that have been delivered using EBP

guidelines.

Another serious barrier is that some healthcare agencies and administrators do not provide the

resources necessary for nurses to implement EBP. Their lack of support might include the follow-

ing: (1) inadequate access to research journals and other sources of synthesized research findings

and evidence-based guidelines; (2) inadequate knowledge on how to implement evidence-based

changes in practice; (3) heavy workload, with limited time to make research-based changes in prac-

tice; (4) limited authority to change patient care based on research findings; (5) limited support

from nursing administrators or medical staff to make evidence-based changes in practice; (6) lim-

ited funds to support research projects and research-based changes in practice; and (7) minimal

rewards for providing evidence-based care to patients and families (Butler, 2011; Eizenberg, 2010;

Straka, Brandt, & Brytus, 2013). The success of EBP is determined by all involved, including

healthcare agencies, administrators, nurses, physicians, and other healthcare professionals. We

all need to take an active role in ensuring that the health care provided to patients and families

is based on the best research available.

SEARCHING FOR EVIDENCE-BASED SOURCES

EBP requires searching a variety of databases and websites for the best research evidence for use in

practice. You can identify research syntheses such as systematic reviews, meta-analyses, meta-

syntheses, and mixed-methods systematic reviews through searches of electronic databases,

national library sites, EBPorganizations, and professional organizations. Some of the key resources

for EBP are identified in Table 13-1. At least 2500 new systematic reviews are reported in English

and indexed in MEDLINE each year (Liberati, Altman, Tetzlaff, Mulrow, Gotzsche, Ioannidis, et al.,

2009). The Cochrane Collaboration library of systematic reviews is an excellent resource, with

more than 11,000 entries relevant to nursing and health care (http://www.cochrane.org/

cochrane-reviews). In 2009, the Cochrane Nursing Care Field (CNCF) was developed to support

the conduct, dissemination, and use of systematic reviews in nursing. The Joanna Briggs Institute

also provides resources for locating and conducting research syntheses in nursing (see Table 13-1).

Chapter 6 provides additional direction for searching electronic databases for individual studies

and research syntheses. Once you have identified research syntheses of interest, you need to

appraise these sources critically for relevant research evidence for use in your practice.

419CHAPTER 13 Building an Evidence-Based Nursing Practice

TABLE 13-1 EVIDENCE-BASED PRACTICE RESOURCES

RESOURCE DESCRIPTION

Electronic Databases

CINAHL (Cumulative Index

to Nursing and Allied

Health Literature)

CINAHL is an authoritative resource covering the English-language journal

literature for nursing and allied health. The database was developed in the

United States and includes sources published from 1982 to the present.

MEDLINE (PubMed,

National Library

of Medicine)

MEDLINE was developed by the National Library of Medicine in the United

States; it provides access to more than 11 million MEDLINE citations back to

the mid-1960s and to additional life science journals.

MEDLINE with MeSH Also developed by the National Library of Medicine, MEDLINE with MeSH

provides authoritative medical information on medicine, nursing, dentistry,

veterinary medicine, the healthcare system, preclinical services, and more.

PsychINFO The American Psychological Association developed this database that includes

professional and academic literature for psychology and related disciplines

from 1887 to the present.

CANCERLIT CANCERLIT, containing information on cancer, was developed by the U.S.

National Cancer Institute.

National Library Sites

Cochrane Library The Cochrane Library provides high-quality evidence for those providing and

receiving health care and those involved in research, teaching, funding, and

administration of health care at all levels. Included is the Cochrane

Collaboration, which has many systematic reviews of research (http://www.

cochrane.org/ reviews).

National Library of Health

(NLH)

NLH, located in the United Kingdom, provides searchable evidence-based

sources at http://www.evidence.nhs.uk.

Evidence-Based Practice Organizations and Collections

National Guideline

Clearinghouse (NGC)

The Agency for Healthcare Research and Quality (AHRQ) developed NGC to

house the thousands of evidence-based guidelines that have been developed

for use in clinical practice; these can be accessed online at http://www.

guidelines.gov.

Cochrane Nursing Care

Field (CNCF)

Cochrane Collaboration includes over 7000 reviews in 11 different fields; one is

the CNCF, which supports the conduct, dissemination, and use of systematic

reviews in nursing. Most libraries subscribe to the Cochrane Collaboration but

free access to abstracts and reviews can be found at http://cncf.cochrane.org.

National Institute for Health

and Clinical Excellence

(NICE)

The NICE was organized in the United Kingdom to provide access to current

evidence-based guidelines, similar to NGC (http://nice.org.uk).

Joanna Briggs Institute (JBI) JBI, an international evidence-based organization originating in Australia, has a

search website that includes evidence summaries, systematic reviews,

systematic review protocols, evidence-based recommendations for practice,

best practice information sheets, consumer information sheets, and technical

reports; see “Search the Joanna Briggs Institute” (http://www.joannabriggs.

edu.au/Search. aspx).

Nursing Reference

Center (NRC)

The NRC includes a collection of rigorously reviewed, evidence-based care sheets

that provide current best practice for over 700 interventions and clinical

conditions. This source requires a subscription, so check with your librarian. You

can access this resource at http://www.ebscohost.com/pointOfCare/nrc-about.

420 CHAPTER 13 Building an Evidence-Based Nursing Practice

CRITICALLY APPRAISING RESEARCH SYNTHESES

Research evidence is usually synthesized using the following processes: systematic review, meta-

analysis, meta-synthesis, and mixed-method systematic review. These synthesis processes were

introduced in Chapter 1, and the following section provides guidelines for critically appraising

these synthesis processes to determine the status of knowledge for use in practice.

Critically Appraising Systematic Reviews A systematic review is a structured, comprehensive synthesis of the research literature to deter-

mine the best research evidence available to address a healthcare question. A systematic review

involves identifying, locating, appraising, and synthesizing quality research evidence for clinicians

to use in practice (Bettany-Saltikov, 2010a; Craig & Smyth, 2012; Higgins & Green, 2008; Liberati

et al., 2009; Rew, 2011). Systematic reviews are often conducted by two or more researchers and/or

clinicians in a selected area of interest to determine the best research knowledge in that area

(see Grove, Burns, & Gray [2013] for the process of conducting a systematic review).

Systematic reviews need to be conducted with rigorous research methodology to promote the

accuracy of the findings and minimize the reviewers’ bias. Table 13-2 provides a checklist for

TABLE 13-2 CHECKLIST FOR CRITICALLY APPRAISING PUBLISHED SYSTEMATIC REVIEWS AND META-ANALYSES

SYSTEMATIC REVIEW STEPS

STEP

COMPLETE

(YES OR NO)

COMMENTS: QUALITY AND

RATIONALE

1. Did the title indicate that a systematic review, meta-

analysis, or both were conducted?

2. Was an abstract included that provided a structured

summary of purpose, data sources, study eligibility

criteria, participants, interventions, outcomes, study

appraisal and synthesis methods, results, key findings,

conclusions, and implications for practice?

3. Was the clinical question clearly expressed and

significant? Was the PICOS (participants, intervention,

comparative interventions, outcomes, and study

design) format used to develop the question and focus

the systematic review or meta-analysis?

4. Were the purpose and objectives or aims of the research

synthesis clearly expressed and used to direct it?

5. Were the search criteria clearly identified? Was the

PICOS format used to identify the search criteria, and

were the years covered, language, and publication

status of sources identified in the search criteria?

6. Was a comprehensive, systematic search of the

literature conducted using explicit criteria identified in

step 3? Were the search strategies clearly reported with

examples? Did the search include published studies,

grey literature, and unpublished studies?

Continued

421CHAPTER 13 Building an Evidence-Based Nursing Practice

TABLE 13-2 CHECKLIST FOR CRITICALLY APPRAISING PUBLISHED SYSTEMATIC REVIEWS AND META-ANALYSES—cont’d

SYSTEMATIC REVIEW STEPS

STEP

COMPLETE

(YES OR NO)

COMMENTS: QUALITY AND

RATIONALE

7. Was publication bias addressed, including any time lag

bias, location bias, duplicate publication bias, citation

bias, and language bias?

8. Was the process for the selection of studies for

the review clearly identified and consistently

implemented? Was the selection process expressed

in a flow diagram such as Figure 13-1?

9. Were key elements (population, sampling process,

design, intervention, outcomes, and results) of each

study clearly identified and presented in a table?

10. Was a quality critical appraisal of the studies

conducted? Were the results related to participants,

types of interventions, outcomes, and outcome

measurement methods? Were possible

methodological and reporting biases clearly discussed

related to each study (i.e., in table and narrative format)?

11. Was a meta-analysis conducted as part of the

systematic review? Was a rationale provided for

conducting the meta-analysis? Were the details of

the meta-analysis process and results clearly described?

12. Were the results of the systematic review or meta-

analysis clearly described (i.e., in narrative and table)?

Were details of the study interventions compared and

contrasted in a table? Were the outcome variables

clearly identified and the quality of the measurement

methods addressed?

13. Did the report conclude with a clear discussion section?

a. Were the review findings summarized to identify the

current best research evidence?

b. Were the limitations of the review and how they

might have affected the findings addressed?

c. Were the recommendations for further research,

practice, and policy development addressed?

14. Did the authors of the review develop a clear, concise,

quality report for publication? Was the report inclusive of

the items identified in the PRISMA statement, which are

included in this table (Liberati et al., 2009; Moher et al.,

2009)?

422 CHAPTER 13 Building an Evidence-Based Nursing Practice

critically appraising the steps of systematic reviews and meta-analyses. These steps are based on the

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA; Liberati et al.,

2009) statement and other relevant sources to guide nurses in conducting systematic reviews

(Bettany-Saltikov, 2010a, 2010b; Higgins & Green, 2008; Moore, 2012; Rew, 2011). The PRISMA

statement was developed in 2009 by an international group of expert researchers and clinicians to

improve the quality of reporting for systematic reviews and meta-analyses. It includes 27 items,

which can be found at http://prisma-statement.org and are detailed in the article by Liberati

and colleagues (2009). If the review process is clearly detailed in the report, others can replicate

the process and verify the findings.

A systematicreview conducted by Choi and Hector (2012) is presented here asan example, with the

application of the critical appraisal steps outlined in Table 13-2. They conducted a systematic review

thatincluded ameta-analysistodetermine theeffectivenessof fallprevention programs inreducing the

number and rate of falls in hospitaland community agencies. You canfind the publication by Choi and

Hector (2012) in the CINAHL database of your closest library (see Table 13-1 for a description of

CINAHL). We recommend that you read this article and use the guidelines in Table 13-2 to critically

appraise this systematic review and compare your findings with the following discussion.

Step 1

Did the title indicate if a systematic review or meta-analysis was conducted? Choi and Hector (2012, p. 188.e21) titled their research synthesis as “Effectiveness of Intervention Programs

in Preventing Falls: A Systematic Review of Recent 10 Years and Meta-Analysis.” The authors

clearly indicated the types of research syntheses (systematic review and meta-analysis) included

in their publication.

Step 2 Did the abstract include a structured summary of the research synthesis? Choi and Hector

(2012) provided a clear, concise abstract that identified the purpose of the systematic review, data

sources, study eligibility criteria, studies selected for review (17 RCTs), types of fall prevention

programs, primary outcomes of number of falls and fall rates, critical appraisal of studies, results,

conclusions, and implications for practice.

Step 3 Was a significant, clear clinical question developed to direct the research synthesis? A sys-

temic review or meta-analysis is best directed by a relevant clinical question that focuses the review

process and promotes the development of a quality synthesis of research evidence. One of the most

common formats used to develop a relevant clinical question to guide a systematic review is the

PICO or PICOS format described in the Cochrane Handbook for Systematic Reviews of Interventions

(Higgins & Green, 2008). The PICOS format includes the following elements:

P—Population or participants of interest (see Chapter 9 on sampling)

I—Intervention needed for practice (see Chapter 8 on nursing interventions)

C—Comparisons of the intervention with control, placebo, standard care, variations of the same

intervention, or different therapies (see Chapter 8)

O—Outcomes needed for practice (see Chapter 10 on measurement methods and Chapter 14 on

outcomes research)

S—Study design (see Chapter 8 on types of study designs)

Choi and Hector (2012) noted that falls were the leading cause of injury and deaths among

older adults, with the direct medical costs estimated to be over $19.2 billion in 2000. Research

423CHAPTER 13 Building an Evidence-Based Nursing Practice

syntheses had been conducted on fall prevention programs from the 1990s to 2000, but not for the

last decade. What was not known was the effectiveness of the fall prevention interventions studied

from 2000 to 2009. The population was older adults, and the intervention was fall prevention pro-

grams. The studies reviewed included different types of interventions, with most of the fall pre-

vention programs including multiple approaches, such as individualized exercises for strength,

coordination and balance, occupational therapy, home environmental and behavioral assessments,

cognition assessment, medical examination, gait stability, and medication review. The intervention

group was compared with groups receiving standard care, no treatment, or a variation of the treat-

ment. The primary outcomes measured were number of falls and fall rate. The study design

included synthesis of only RCTs using guidelines from the Cochrane Collaboration handbook

(Higgins & Green, 2008; see Chapter 8 for a description of RCTs). The study design (RCTs) clearly

focused the literature review but might have eliminated some important studies that could have

expanded the knowledge related to the intervention, fall prevention programs.

Step 4

Were the purpose and objectives or aims of the review expressed? Systematic reviews of research include a purpose and sometimes specific aims or objects to guide the synthesis process

(Bettany-Saltikov, 2010a; Rew, 2011). The purpose identifies the major goal or focus of the review.

Choi and Hector (2012, p. 188.e13) identified their purpose as follows: “To examine the reported

effectiveness of fall-prevention programs for older adults by reviewing randomized controlled tri-

als from 2000 to 2009.” This clearly focused purpose was used to direct their systematic review and

meta-analysis, and no additional objectives were identified.

Step 5

Was the literature search criteria clearly identified? Research reports of systematic reviews or meta-analyses need to identify the inclusion and exclusion criteria used to direct the literature

search (see Table 13-2). The PICOS format might be used to develop the search criteria with

more detail being developed for each of the elements. These search criteria might focus on the

following: (1) type of research methods, such as quantitative, qualitative, or outcomes research;

(2) population or type of study participants; (3) study designs, such as description, correlational,

quasi-experimental, experimental, qualitative, or mixed methods; (4) sampling processes, such as

probability or nonprobability sampling methods; (5) intervention and comparison interventions;

and (6) specific outcomes to be measured. The search criteria also need to indicate the years for

the review, language, and publication status (Bettany-Saltikov, 2010b; Higgins & Green, 2008;

Rew, 2011).

Often searches have been limited to published sources in common databases, which excludes

the grey literature from the research synthesis. Grey literature refers to studies that have limited

distributions, such as theses and dissertations, unpublished research reports, articles in obscure

journals, articles in some online journals, conference papers and abstracts, conference proceedings,

research reports to funding agencies, and technical reports (Benzies, Premji, Hayden, & Serrett,

2006; Conn, Valentine, Cooper, & Rantz, 2003). Most grey literature is difficult to access through

database searches and is often not peer-reviewed, with limited referencing information. These are

some of the main reasons why grey literature is not included in systematic reviews and meta-

analyses. However, excluding grey literature might result in misleading, biased results. Studies with

significant findings are more likely to be published than studies with nonsignificant findings and

are usually published in more high-impact, widely distributed journals that are indexed in com-

puterized databases (Conn et al., 2003). Studies with significant findings are more likely to have

424 CHAPTER 13 Building an Evidence-Based Nursing Practice

duplicate publications, which should not be included in the systematic review or meta-analysis.

More details on identifying publication bias are provided in the next section on critically apprais-

ing meta-analyses.

Choi and Hector (2012) designed their literature search strategies and their protocol for con-

ducting their systematic review using sources such as the Cochrane Collaboration handbook

(Higgins & Green, 2008) and the PRISMA statement (Liberati et al., 2009; Moher, Liberati,

Tetzlaff, Altman, & PRISMA Group, 2009). PICOS format was also implemented with the litera-

ture search being directed by population of older adults, intervention of fall prevention programs,

comparison of intervention groups with standard care and control groups, outcomes of number of

falls and fall rates, and study designs limited to RCTs. The date restriction for the search was 2000 to

2009 based on the lack of research syntheses conducted in the last decade. The search was limited to

published studies reported in English, which could result in important studies being omitted from

the systematic review.

Step 6

Was a comprehensive, systematic search of the research literature conducted? The key search terms, different databases searched, and search results need to be recorded in the systematic

review and meta-analysis publications. Sometimes authors provide a table that identifies the search

terms and criteria. The PRISMA statement recommends presenting the full electronic search strat-

egy used for at least one major database, such as CINAHL or MEDLINE (Liberati et al., 2009). The

search strategies used to identify grey literature and other unpublished studies need to be

identified.

Choi and Hector (2012, p. 188.e14) described their search of the literature in the following:

“A thorough search of the scientific and medical literature was conducted using major biomed-

ical electronic databases: Medline, PubMed, PsycINFO, CINAHL, and RefWorks. This rigorous

literature examination selected articles in peer-reviewed journals published in the English lan-

guage, with full-text availability, targeting both men and women, in RCTs, with primary out-

comes measures as either the number of falls or the fall rate, with fall-intervention follow-up of a

minimum of 5 months, and published from 2000 to 2009. We excluded articles with unidentified

study design. . . . Key words used were the combination of falls, recurrent falls, fall-prevention programs, interventions, programs, injuries, older adults, RCTs, and/or long-term care facilities.

A total of 17,325 studies were generated from the 5 electronic data bases.”

Step 7 Was publication bias addressed? Choi and Hector (2012) recognized the publication bias

that occurs with using only published sources and not including grey literature. They also limited

their search to the English language, resulting in a language bias. They noted that 33 studies were

duplicated across the databases, and these were excluded, thus reducing the potential for

duplication bias.

Step 8

Was the process for selecting the studies for review detailed? The selection of studies for inclusion in a systematic review or meta-analysis is a complex process that initially involves

the review and removal of duplicate sources. The abstracts of the remaining studies are reviewed

by two or more authors and sometimes by an external reviewer to ensure that they meet the

criteria identified in step 5 (see Table 13-2). The abstracts might be excluded based on the study

425CHAPTER 13 Building an Evidence-Based Nursing Practice

participants, interventions, outcomes, or design not meeting the search criteria (Bettany-Saltikov,

2010b; Higgins & Green, 2008; Liberati et al., 2009). After the abstracts meeting the designated

criteria are identified, the next step is to retrieve the full-text citation for each study. If studies

do not meet criteria, they need to be removed, with a rationale provided. The study selection pro-

cess is best demonstrated by a flow diagram that was developed by the PRISMA Group (Liberati

et al., 2009). Figure 13-1 shows this diagram, which has four phases: (1) identification of the

sources; (2) screening of the sources based on set criteria; (3) determining if the sources meet eli-

gibility requirements; and (4) identifying the studies included in the review.

Choi and Hector (2012) provided a description of their selection of sources and a flow diagram

that documented the final results of the 17 RCTs included in their systematic review, with a

Records identified through database searching

(n = )

S c re

e n

in g

In c

lu d

e d

E li g

ib il it

y Id

e n

ti fi

c a ti

o n

Additional records identified through other sources

(n = )

Records after duplicates removed (n = )

Records screened (n = )

Records excluded (n = )

Full-text articles assessed for eligibility

(n = )

Full-text articles excluded, with reasons

(n = )

Studies included in qualitative synthesis

(n = )

Studies included in quantitative synthesis

(meta-analysis) (n = )

FIG 13-1 PRISMA 2009 Flow Diagram. Identification, screening, eligibility, and inclusion of research sources in systematic reviews and meta-analyses. (From Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & PRISMA Group. (2009). Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. Retrieved July 17, 2013, from http:// www.prisma-statement.org.)

426 CHAPTER 13 Building an Evidence-Based Nursing Practice

meta-analysis. The following excerpt identifies the steps that they took to select their studies for

inclusion in their research synthesis:

“There were 33 studies duplicated across databases that were excluded.. . . Studies with titles and abstracts unlikely to be relevant were excluded (n¼15,419) followed by exclusion of studies that did not identify an RCT (n¼1619). A total of 287 potentially relevant studies were reviewed by the primary author (M. C.). We excluded studies of fall-prevention programs for children

(n¼27). The primary search (completed from July 2009 to March 2010) generated a total of 227 studies. . . . Of the 227 publications that met the criteria for meta-analysis, 17 studies remained [Figure 13-2].”

Choi and Hector, 2012, p. 188.e14

Titles and abstracts were reviewed via electronic search

(n = 17,325)

Potentially relevant studies were reviewed

(n = 287)

Potentially relevant studies were reviewed

(n = 227)

Potentially relevant studies were reviewed

(n = 21)

Titles and abstracts unlikely to be relevant were excluded

(n = 15,419) Studies that did not identify RCT were excluded

(n = 1,619)

Studies that included children falls were excluded (n = 27)

Studies duplicates were excluded (n = 33)

Studies that did not report fall intervention or effectiveness of the program were excluded

(n = 151) Studies that identified unclear intervention period or did not meet the intervention period, and quasi-

experimental design studies were excluded (n = 40)

Studies that did not include both men and women were excluded

(n = 15)

Studies completed with unreliable follow-up were excluded

(n = 4) Final studies included in the meta-analysis

(n = 17)

FIG 13-2 Flow chart of study selection. (From Choi, M., & Hector, M. (2012). Effectiveness of intervention programs in preventing falls: A systematic review of recent 10 years and meta- analysis. Journal of the American Medical Directors Association, 13(2), 188.e15. Figure 1.)

427CHAPTER 13 Building an Evidence-Based Nursing Practice

Step 9

Were key elements of the studies presented? Critical appraisals of studies for systematic reviews and meta-analyses are best done by constructing a table describing the characteristics

of the included studies, such as the purposes of the studies, populations, sampling processes, inter-

ventions, outcomes, and results (Bettany-Saltikov, 2010b; Higgins & Green, 2008; Liberati et al.,

2009). Choi and Hector (2012) detailed the key elements of the 17 studies in a table. The table

included authors of the study, year, sample size of control and intervention groups, intervention

and follow-up period, intervention model, setting, mean age of subjects, and brief description of

the intervention programs. The table would have been stronger if the sampling methods, outcomes

measured, and key results for the 17 studies had been included in a table format.

Step 10 Were the studies critically appraised? Two or more experts need to review the studies inde-

pendently and make judgments about their quality. The critical appraisal of the studies is often

difficult because of the differences in types of participants, designs, sampling methods, interven-

tion protocols, outcome variables and measurement methods, and presentation of results. The

studies are often rank-ordered based on their quality and contribution to the development of

the review (Bettany-Saltikov 2010b; Liberati et al., 2009). Choi and Hector’s (2012) critical

appraisal of the 17 studies involved examining the sample characteristics in the studies, types

of interventions, settings of interventions, and intensity of the intervention. The final results of

the studies were pooled using a meta-analysis.

Step 11 Was a meta-analysis conducted as part of the systematic review? Some authors conduct a

meta-analysis in the synthesis of sources for their systematic review (Liberati et al., 2009). Because

a meta-analysis involves the use of statistics to summarize results of different studies, it usually pro-

vides strong, objective information about the effectiveness of an intervention or solid knowledge

about a clinical problem. The authors of the review need to provide a rationale for conducting

the meta-analysis and detail the process that they used to conduct this analysis. For example, a

meta-analysis might be conducted on a small group of similar studies to determine the effect of

an intervention. The systematic review conducted by Choi and Hector (2012) included a meta-

analysis of the 17 studies and provided a detailed discussion of the rationale for the meta-analysis

and results for this procedure. The next section provides more details on conducting a meta-analysis.

Step 12

Were the results of the review clearly presented? The results of a systematic review and meta-analysis should include a description of the study participants, types of interventions

implemented in the studies, outcomes measured, and measurement methods. The results of the

different types of intervention might be best summarized in a table that includes the following:

(1) study source; (2) structure of the intervention (stand-alone or multifaceted); (3) specific type

of intervention (e.g., physiological treatment, education, counseling, or behavioral therapy);

(4) delivery method (e.g., demonstration and return demonstration, verbal, video, or self-

administered); (5) length of time the intervention is implemented; and (6) statistical difference

between the intervention and control, standard care, placebo, or alternative intervention groups

(Liberati et al., 2009).

The specific outcomes, including primary and secondary outcomes, of the studies might also be

best summarized in a table. This table might include (1) the study source, (2) outcome variable(s),

428 CHAPTER 13 Building an Evidence-Based Nursing Practice

with an indication as to whether it was a primary or secondary outcome in the study, (3) measure-

ment method used for each study outcome variable, and (4) quality of the measurement methods,

such as the reliability and validity of a scale or the precision and accuracy of a physiological measure.

Choi and Hector (2012) included a description of the 17 fall prevention interventions in a table

indicating that most of the interventions were multifactorial rather than an individual action. The

interventions and their follow-up period had to be at least 5 months. The authors indicated that

the primary outcomes of number of falls and fall rates were measured in different ways in the stud-

ies, which limited the quality of the results and findings of the systematic review and meta-analysis.

The following excerpt presents the key results from the systematic review and meta-analysis:

“Overall, a significant 14% fall reduction was found in the number of falls and fall rate during

the follow-up along with an even more significant fall reduction in multifactorial interventions

studies (n¼15, 14%) and nursing homes (n¼3, 55%). The significant fall-prevention effect in multifactorial intervention program in our analysis was consistent with results of several prior

studies and inconsistent with 2 earlier meta-analysis efforts that reported that a single interven-

tion specifically focusing on exercise alone was more effective in reducing falls. . . . The intensity of the intervention did not demonstrate any significant fall reduction rate.”

Choi & Hector, 2012, p. 188.e19

Step 13 Did the report conclude with a clear discussion section? In a systematic review or meta-

analysis, the discussion of the findings includes an overall evaluation of the types of interventions

implemented and the outcomes measured. You can also expect the methodological issues or lim-

itations of the review to be addressed. A quality discussion section explicitly connects the findings

to the study’s framework to identify the theoretical implications of the findings. Finally, the dis-

cussion section needs to provide recommendations for further research, practice, and policy devel-

opment (Bettany-Saltikov, 2010b; Higgins & Green, 2008; Liberati et al., 2009).

Choi and Hector (2012) provided a discussion of their findings, limitations, and recommen-

dations for research and practice. The report would have been strengthened by including a frame-

work and linking the findings back to the framework to indicate current knowledge regarding the

effect of fall prevention programs on number of falls and fall rates. The following excerpt summa-

rizes the key aspects of the discussion section of their report:

“We conclude that interventions to prevent falls in older adults were modestly effective, in mul-

tifactorial intervention with a 10% reduction in fall rates, 9% in community settings, and 12%

on Model 1 intervention types (initial intervention and subsequent follow-up)” (Choi & Hector,

202 p 188.e20).

The limitations included studies with small sample sizes, varying types of fall prevention inter-

ventions, and measurements of outcomes of number of falls and fall rate in various ways. Several of

the 17 studies concluded that the intervention made no significant difference. They also noted that

the search of the literature might have been more rigorous in identifying additional studies.

“We found a few observations that might be valuable for future research. Studies need to be

carefully designed to examine their results over an extended period of time (at least 6 months)

if they are to be meaningful. Excluding observational studies with significant variations of out-

come measures would help to reduce confounders. Eliminating quasi-experimental studies

would help to yield an unbiased estimate of the effect size. Including only studies of RCTs

429CHAPTER 13 Building an Evidence-Based Nursing Practice

may reduce publication bias.. . . We certainly would encourage the inclusion of more random- ized controlled studies to reduce sampling error variation, even if the results turned out not to be

positive.”

Choi and Hector, 2012, p. 188.e20

Implications for practice

“Implementing intervention programs to prevent falls by older adults seems to be plausible and

highly desirable, but the overall effectiveness of intervention programs are not supported strongly

by significant statistical results. The following are recommendations for healthcare providers to

attempt to reduce fall rates in clinical practice: (1) identify an individual’s risk factors for falls;

(2) determine predisposing and precipitating factors if the patient has a history of falls, and

intervene accordingly; (3) provide intervention programs and management focusing on

lower-extremity balance and strengthening; (4) consider psychological factors such as fear of fall-

ing and self-imposed restriction of activity; and (5) classify injuries when they do occur based on

the International Classification of Diseases.”

Choi & Hector, 2012, p. 188.e20

Systematic reviews and meta-analyses provide important, evidence-based knowledge for use in

practice. Choi and Hector’s (2012) recommendations provide clear evidence-based interventions

that students and RNs might use to reduce the falls in their agencies and institutions. The QSEN

(2013) implication is that critically appraising systematic reviews and using relevant evidence in

practice is essential for achieving EBP.

Step 14

Was a clear concise report developed for publication? The systematic review or meta-analysis report needs to include the content discussed in the previous 13 steps. You can use Table 13-2 when

critically appraising a systematic review, indicate if the step is present, and comment about its qual-

ity with, supporting rationale. In summary, Choi and Hector (2012) developed a strong systematic

review and meta-analysis for publication. The title clearly indicates the types of syntheses con-

ducted. The clinical question addressed followed the PICOS format, and the purpose of the syn-

thesis is clearly focused. The search of the literature might have been more rigorous and included

additional studies, especially grey literature. The selection of studies for the synthesis was clearly

presented in a flow chart and documented with rationale. The studies selected for the systematic

review and meta-analysis were critically appraised, and the results from these syntheses were clearly

presented in tables and narrative. The publication concluded with relevant findings, limitations,

and recommendations for research and practice.

Critically Appraising Meta-Analyses A meta-analysis is conducted to pool or combine statistically the results from previous studies into

a single quantitative analysis that provides one of the highest levels of evidence about the effective-

ness of an intervention (Andrel, Keith, & Leiby, 2009; Craig & Smyth, 2012; Higgins & Green, 2008;

Liberati et al., 2009). This approach has objectivity because it includes analysis techniques to deter-

mine the effect of an intervention while examining the influences of variations in the studies

included in the meta-analysis. The studies included in a meta-analysis need to be examined for

variations or heterogeneity in areas such as sample characteristics, sample size, design, types of

interventions, and outcome variables and measurement methods (Higgins & Green, 2008).

430 CHAPTER 13 Building an Evidence-Based Nursing Practice

Heterogeneity in the studies included in a meta-analysis can lead to different types of biases (see

later). Meta-analyses that include more homogeneous (similar) studies have less bias and usually

provide more valid findings (Moore, 2012).

Statistically combining data from several studies results in a large sample size, with increased

power to determine the true effect of a specific intervention on a particular outcome (see Chapter 9

for a discussion of power). The ultimate goal of a meta-analysis is to determine if an intervention

(1) significantly improves outcomes, (2) has minimal or no effect on outcomes, or (3) increases the

risk of adverse events. Meta-analysis is also an effective way to resolve conflicting study findings

and controversies that have arisen related to a selected intervention (Higgins & Green, 2008).

Strong evidence for using an intervention in practice can be generated from a meta-analysis of

multiple, quality studies such as RCTs and quasi-experimental studies. However, the conduct of a

meta-analysis depends on the accuracy, clarity, and completeness of information presented in

studies. Box 13-1 provides a list of information that needs to be included in a research report

BOX 13-1 RECOMMENDED REPORTING FOR AUTHORS TO FACILITATE META-ANALYSIS

Demographic Variables Relevant to Population Studied

Age

Gender

Marital status

Ethnicity

Education

Socioeconomic status

Methodological Characteristics

Sample size (experimental and control groups)

Type of sampling method

Sampling refusal rate and attrition rate

Sample characteristics

Research design

Groups included in study—experimental, control, comparison, placebo groups

Intervention protocol and fidelity discussion

Data collection techniques

Outcome measurements

• Reliability and validity of instruments

• Precision and accuracy of physiological measures

Data Analysis

Names of statistical tests

Sample size for each statistical test

Degrees of freedom for each statistical test

Exact value of each statistical test

Exact p value for each test statistic

One-tailed or two-tailed statistical test

Measures of central tendency (mean, median, and mode)

Measures of dispersion (range, standard deviation)

Post hoc test values for ANOVA (analysis of variance) test of three or more groups

431CHAPTER 13 Building an Evidence-Based Nursing Practice

to facilitate the conduct of a meta-analysis. You might use the information in Box 13-1 as a check-

list to determine if the reports of RCTs and quasi-experimental studies are complete.

The steps for critically appraising a meta-analysis are similar to those for critically appraising a

systematic review that were detailed earlier (see Table 13-2). The following information is provided

to increase your ability to appraise critically meta-analysis studies. The PRISMA statement,

Cochrane Collaboration guidelines for meta-analysis (Higgins & Green, 2008), and other resources

(Andrel et al., 2009; Conn & Rantz, 2003; Moore, 2012; Turlik, 2010) were used to provide details

for critically appraising a meta-analysis. Conn’s (2010) meta-analysis to determine the effect of

physical activity interventions on depressive symptom outcomes in healthy adults is presented

as an example.

Clinical Question for a Meta-Analysis The clinical question developed for a meta-analysis is usually clearly focused: “What is the effec-

tiveness of a selected intervention?” The PICOS (participants or population, intervention, com-

parative interventions, outcomes, and study design) format discussed earlier might be used to

generate the clinical question (Higgins & Green, 2008; Liberati et al., 2009; Moher et al., 2009).

Conn (2010) indicated that only one previous meta-analysis had examined the effect of physical

activities (PAs) on depressive symptoms among subjects without clinical depression. Therefore,

Conn wanted to address the following clinical question: “What is the effect of PA on depressive

symptoms in healthy adults?”

Purpose and Questions to Direct a Meta-Analysis Researchers need to identify the purpose of their meta-analysis and the questions or objectives that

guide the analysis. Conn clearly identified the following relevant purpose and research questions to

guide her meta-analysis:

“This meta-analysis synthesized depressive symptom outcomes of supervised and unsupervised

PA interventions among healthy adults. . . . This meta-analysis addressed the following research questions:

(1) What are the overall effects of supervised PA and unsupervised PA interventions on depres-

sive symptoms in healthy adults without clinical depression?

(2) Do interventions’ effects on depressive symptom outcomes vary depending on intervention,

sample, and research design characteristics?

(3) What are the effects of interventions on depressive symptoms among studies comparing

treatment subjects with before versus after interventions?”

Conn, 2010, pp. 128-129

Search Criteria and Strategies for Meta-Analyses

The methods for identifying search criteria and selecting search strategies are similar for meta-

analyses and systematic reviews. The search criteria are usually narrowly focused for a meta-

analysis to identify the specific studies examining the effect of a particular intervention. The search

needs to be rigorous and should include published sources identified through varied databases and

unpublished studies identified through other types of searches (see earlier). Conn (2010) clearly

identified her detailed search strategies in the following excerpt. She used ancestry searches, which

involves the use of citations from relevant studies to identify additional studies.

432 CHAPTER 13 Building an Evidence-Based Nursing Practice

Primary Study Search Strategies

“Multiple search strategies were used to ensure a comprehensive search and thus limit bias while

moving beyond previous reviews. An expert reference librarian searched 11 computerized data-

bases (e.g., MEDLINE, PsychINFO, EMBASE) using broad search terms (sample MEDLINE

intervention terms: adherence, behavior therapy.. . . PA terms: exercise, physical activity, phys- ical fitness). . .. Search terms for depressive symptoms were not used to narrow the search because many PA intervention studies report depressive symptom outcomes but do not consider these the

main outcomes of the study and thus papers are not indexed by these terms. Several research

registers were examined including Computer Retrieval of Information on Scientific Projects

and RCT, which contains 14 active registers and 16 archived registers. Computerized author

searches were completed for project principal investigators located from research registers and

for the first three authors on eligible studies. Author searches were completed for dissertation

authors to locate published papers. Ancestry searches were conducted on eligible and review

papers. Hand searches were completed for 114 journals which frequently report PA intervention

research.”

Conn, 2010, p. 129

Possible Biases for Meta-Analyses and Systematic Reviews Even with rigorous literature searches, authors of meta-analyses and systematic reviews are often

limited to mainly published studies. The nature of the sources can lead to biases and flawed or

inaccurate conclusions in the research syntheses. The common biases that can occur in conducting

and reporting research syntheses include publication bias (e.g., time lag bias, location bias, dupli-

cate publication bias, citation bias, and language bias); bias from poor study methodology; and

outcome reporting bias (see Table 13-2). Publication bias occurs because studies with positive

results are more likely to be published than studies with negative or inconclusive results.

Higgins and Green (2008) found that the odds were four times greater that positive study results

would be published versus negative results. Time lag bias of studies, a type of publication bias,

occurs because studies with negative results are usually published later, sometimes 2 to 3 years later,

than studies with positive results. Sometimes studies with negative results are not published at all,

whereas studies with positive results might be published more than once (duplicate publication

bias). Location bias of studies can occur if studies are published in lower impact journals and

indexed in less searched databases. A citation bias occurs when certain studies are cited more often

than others and are more likely to be identified in database searches. Language bias can occur if

searches focus just on studies in English, and important studies exist in other languages.

Methodological bias is often related to design and data analysis problems in studies. For exam-

ple, studies might have limitations related to the sample, intervention, outcome measurements,

and analysis techniques that result in methodological bias. Outcome reporting bias occurs when

study results are not reported clearly and with complete accuracy. For example, reporting bias

occurs when researchers selectively report positive results and not negative results, or positive

results might be addressed in detail, with limited discussion of negative results. Higgins and

Green (2008) provided a much more comprehensive discussion of potential biases in systematic

reviews and meta-analyses.

Publication, methodological, and outcome reporting biases can weaken the validity of the find-

ings from meta-analyses and systematic reviews. An analysis method termed the funnel plot can be

used to assess for biases in a group of studies. Funnel plots provide graphic representations of

433CHAPTER 13 Building an Evidence-Based Nursing Practice

possible effect sizes (ESs) for interventions in selected studies (see Chapter 9 for the calculation of

ES). The ES, or strength of an intervention in a study, can be calculated by determining the dif-

ference between the experimental and control groups for the outcome variable. The mean

difference between the experimental and control groups for several studies is easier to determine

if the outcome variable is measured by the same scale or instrument in each study. However, the

standardized mean difference (SMD) must be calculated in a meta-analysis when the same out-

come, such as depression, is measured by different scales or methods. More details are provided

on SMD later in this section.

Figure 13-3 shows a funnel plot of the SMDs from 13 individual studies. The SMDs from the

studies are fairly symmetrical or are equally divided by the line through the middle of the funnel in

the graph. A symmetrical funnel plot indicates limited publication bias. Asymmetry of the funnel

plot is mainly the result of publication bias but also of methodological bias, reporting bias, het-

erogeneity in the studies’ sample sizes and interventions, and chance. In Figure 13-3, the studies

with small sample sizes are toward the bottom of the graph, and the studies with larger samples are

toward the top. Figure 13-3 is presented to help you understand the funnel plot diagrams included

in systematic reviews and meta-analyses.

Conn (2010) provided a quality discussion of her literature search results and the risk of pub-

lication bias in her meta-analysis. The following includes key content related to the search results

and the possible biases:

“Comprehensive searches yielded 70 reports.. . . The supervised PA [physical activity] two-group comparison included 1,598 subjects. The unsupervised PA two-group comparison included 1,081

subjects. The treatment single-group comparisons included 1,639 supervised PA and 3,420 unsu-

pervised PA subjects.. . . Most primary studies were published articles (s¼54), and the remain- der were dissertations (s¼14), book chapter (s¼1), and conference presentation materials (s¼1; s indicates the number of reports). Publication bias was evident in the funnel plots for supervised and unsupervised PA two-group outcome comparisons and for treatment group,

pre- vs. post-intervention supervised PA and unsupervised PA comparisons. The control group

pre- and post-comparison distributions on the funnel plots suggested less publication bias than

plots of treatment groups. Unless otherwise specified, all results are from the treatment vs. control

comparisons.”

Conn, 2010, p. 131

S tu

d y

S iz

e

0.0 Standardized Mean Difference (SMD) for RCTs

0.1 0.2 0.3 0.4 0.5 0.6

FIG 13-3 Funnel plot of standardized mean differences (SMDs) for randomized controlled trials (RCTs) with limited bias. (From Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of nursing research: Appraisal, synthesis, and generation of evidence (7th ed.). St. Louis: Elsevier Saunders.)

434 CHAPTER 13 Building an Evidence-Based Nursing Practice

Results of Meta-Analysis for Continuous Outcomes

Many nursing studies examine continuous outcomes or outcomes that are measured by methods

that produced interval- or ratio-level data. Physiological measures to examine blood pressure pro-

duce ratio-level data. Likert scales, such as the Center for Epidemiologic Studies Depression Scale

(CES-D), produce interval-level data (see Chapter 10 for a copy of the CES-D). Therefore, blood

pressure and depression are continuous outcomes. The effect of an intervention on a continuous

outcome in a meta-analysis is determined by the mean difference between two groups. The mean

difference is a standard statistic that identifies the absolute difference between two groups. It is an

estimate of the amount of change caused by the intervention (e.g., physical activity) on the out-

come (e.g., depression), on average, compared with the control group. The mean difference is

reported in a meta-analysis to identify the effect of an intervention but is appropriate only if

the outcome is measured by the same scale in all the studies (Higgins & Green, 2008).

A standardized mean difference (SMD), or d, is a summary statistic that is reported in a meta-

analysis when the same outcome is measured by different scales or methods. The SMD is also

sometimes referred to as the standardized mean effect size. For example, in the meta-analysis

by Conn (2010), depression was commonly measured with three different scales—Profile of Mood

States, Beck Depression Inventory, and CES-D. Studies that have differences in means in the same

proportion to the standard deviations have the same SMD (d), regardless of the scales used to mea-

sure the outcome variable. The differences in the means and standard deviations in the studies are

assumed to be the result of the measurement scales and not variability in the outcome (Higgins &

Green, 2008, p. 256).

Conn’s (2010) meta-analysis result identified a standardized mean effect size of 0.372 (moderate

ES) between the treatment and control groups for the 38 supervised PA studies and SMD of 0.522

(strong ES) among the 22 unsupervised PA studies. (Chapter 9 provides values for determining small,

moderate, and strong ESs.) This meta-analysis documented that supervised and unsupervised PA

reduced symptoms of depression in healthy adults or adults without clinical depression. Therefore,

a decrease in depression is another important reason for encouraging patients to be involved in struc-

tured and unstructured physical activities. The results of this meta-analysis support the QSEN (2013)

competencies of locating, reading, and integrating research evidence in practice.

Results of Meta-Analysis for Dichotomous Outcomes

If the outcome data examined in a meta-analysis are dichotomous, risk ratios, odds ratios, and risk

differences are usually reported to indicate the effect of the intervention on the measured outcome.

These terms are introduced in this chapter, but more information is available in Craig and Smyth

(2012), Higgins and Green (2008), and Sackett and associates (2000). With dichotomous data,

every participant fits into one of two categories, such as clinically improved or no clinical improve-

ment, effective screening device or ineffective screening device, or alive or dead. The risk ratio, also

called the relative risk (RR), is the ratio of the risk of subjects in the intervention group to the risk

of subjects in the control group for having a particular health outcome. The health outcome is

usually adverse, such as the risk of a disease (e.g., cancer) or the risk of complications or death

(Higgins & Green, 2008).

The odds ratio (OR) is defined as the ratio of the odds of an event occurring in one group,

such as the treatment group, to the odds of it occurring in another group, such as the standard

care group. The OR is a way of comparing whether the odds of a certain event is the same for

two groups. An example is the odds of medication adherence or nonadherence for an experimental

group receiving education and specialized medication packaging intervention versus a group

receiving standard practice or care.

435CHAPTER 13 Building an Evidence-Based Nursing Practice

The risk difference (RD), also called the absolute risk reduction, is the risk of an event in the

experimental group minus the risk of the event in the control or standard care group. Higgins

and Green (2008), Fernandez and Tran (2009), and Grove and co-workers (2013) provide more

details on the results from meta-analyses with dichotomous data.

Magnus, Ping, Shen, Bourgeois, and Magnus (2011) conducted a meta-analysis of the effective-

ness of mammography screening in reducing breast cancer mortality in women 39 to 49 years old.

Because mammography screening is significant in reducing breast cancer mortality in women

older than 50 years, and early detection of breast cancer increases survival, annual routine mam-

mography screening has been recommended for all women 40 to 47 years old in the United States.

Thus, “the primary aim of the current study was, after a quality assessment of identified random-

ized controlled trials (RCTs), to conduct a meta-analysis of the effectiveness of mammography

screening [intervention] in women aged 39-49 [population] in reducing breast cancer mortality

[dichotomous outcome]. The second aim was to compare and discuss the results of previously pub-

lished meta-analyses” (Magnus et al., 2011, p. 845). The following describes the methods, results,

and conclusions of this meta-analysis:

“Methods: PubMed/MEDLINE, OVID, COCHRANE, and Educational Resources Information

Center (ERIC) databases were searched, and extracted references were reviewed. Dissertation

abstracts and clinical trials databases available online were assessed to identify unpublished

works. All assessments were independently done by two reviewers. All trials included were RCTs,

published in English, included data on women aged 39-49, and reported relative risk (RR)/odds

ratio (OR) or frequency data.

Results: Nine studies were identified. . . . The individual trials were quality assessed, and the data were extracted using predefined forms. . . . Seven RCTs with the highest quality score were combined, and a significant pooled RR estimate of 0.83 (95% confidence interval [CI] 0.72-

0.97) was calculated.”

Magnus et al., 2011, p. 845

The results of the study are graphically represented in Figure 13-4 using a forest plot. A forest

plot is a type of diagram used to present the meta-analysis results of studies with dichotomous

outcomes (Grove et al., 2013; Fernandez & Tran, 2009). The plot clearly identifies the names of

the seven studies included in the meta-analysis on the left side of the figure. The RR and CI for

each study are identified with a block and horizontal line. The numerical RR and 95% CI values

are identified on the right side of the plot, with the percentage of weight given to each study in the

meta-analysis. Most of the studies show homogeneity with odds ratios left of the vertical line,

except for the Stockholm study. Magnus and colleagues (2011, p. 845) concluded that “Mammog-

raphy screenings were effective and generate a 17% reduction in breast cancer mortality in women

39-49 years of age. The quality of the trials varied, and providers should inform women in this age

group about the positive and negative aspects of mammography screenings.”

Critically Appraising Meta-Syntheses Qualitative research synthesis is the process and product of systematically reviewing and formally

integrating the findings from qualitative studies (Sandelowski & Barroso, 2007). The process for con-

ducting a synthesis of qualitative research is still evolving. Various synthesis methods have appeared

in the literature, such as meta-synthesis, meta-ethnography, meta-study, meta-narrative, qualitative

metasummary, qualitative meta-analysis, and aggregated analysis (Barnett-Page & Thomas, 2009;

Kent & Fineout-Overholt, 2008; Sandelowski & Barroso, 2007; Walsh & Downe, 2005). Despite San-

delowski and Barroso receiving NIH funding to develop meta-synthesis processes, qualitative

436 CHAPTER 13 Building an Evidence-Based Nursing Practice

researchers are currently not in agreement that it is possible to meta-synthesize qualitative studies or,

if it is, what is the appropriate method to use to accomplish this process. Despite the lack of con-

sensus on the process for meta-syntheses, qualitative researchers recognize the importance of sum-

marizing qualitative findings to determine the knowledge that might be used in practice and for

policy development (Barnett-Page & Thomas, 2009; Finfgeld-Connett, 2010; Sandelowski &

Barroso, 2007). The Cochrane Collaboration recognizes the importance of synthesizing qualitative

research, and the Cochrane Qualitative Methods Group was developed as a forum for the discussion

and development of methodology in this area (Higgins & Green, 2008).

The qualitative research synthesis method that seems to be gaining momentum in the nursing

literature is meta-synthesis. Methodological articles have been published to describe meta-

synthesis, but this method is still evolving (Finfgeld-Connett, 2010; Kent & Fineout-Overholt,

2008; Walsh & Downe, 2005). A meta-synthesis is defined as the systematic compilation and inte-

gration of qualitative study results to expand understanding and develop a unique interpretation

of study findings in a selected area. The focus is on interpretation rather than on combining study

results, as with quantitative research synthesis. A meta-synthesis involves the breaking down of

findings from different studies to discover essential features and then combining these ideas into

a unique, transformed whole. Sandelowski and Barroso (2007) identified metasummary as a step

in conducting meta-synthesis. A metasummary is the summarizing of findings across qualitative

Study Name Risk Ratio (95% CI)

% Weight

Stockhoim

Gothenburg

Malmö

Age Trial

Canada

HIP

Edinburgh

Overall

1.52 (0.80, 2.88)

0.55 (0.31, 0.95)

0.73 (0.51, 1.04)

0.83 (0.66, 1.04)

0.97 (0.74, 1.27)

0.77 (0.53, 1.11)

0.79 (0.53, 1.17)

0.83 (0.72, 0.97)

5.16

6.68

14.27

26.89

21.52

13.45

12.03

.25 .5 .75 1 1.25

Risk Ratio

1.75 21.5

FIG 13-4 Forest Plot. This shows the individual randomized controlled trials and overall pooled estimate from the seven original randomized controlled trials, with a high-quality score addressing the impact of mammography screening on breast cancer mortality in women 39 to 49 years old. CI, Confidence interval. (From Magnus, M. C., Ping, M., Shen, M. M., Bourgeois, J., & Magnus, J. H. (2011). Effectiveness of mammography screening in reducing breast cancer mortality in women aged 39-49 years: A meta-analysis. Journal of Women’s Health, 20(6), 848.)

437CHAPTER 13 Building an Evidence-Based Nursing Practice

reports to identify knowledge in a selected area. A process for critically appraising a meta-synthesis

is described in the following section. A meta-synthesis conducted by Denieffe and Gooney (2011,

p. 424) is presented as an example. The authors titled their report “A Meta-Synthesis of Women’s

Symptoms Experience and Breast Cancer.” They developed a concise, relevant abstract of the aim,

questions used to direct synthesis, meta-synthesis process for data collection and analysis, findings,

and implications for practice. The guidelines in the box below were used to critically appraise the

study by Denieffe and Gooney.

Framing for the Meta-Synthesis

Researchers need to provide the frame for their meta-synthesis in their report (Kent & Fineout-

Overholt, 2008; Walsh & Downe, 2005). The frame identifies the focus and scope of the meta-

synthesis. The focus of the meta-synthesis is usually an important area of interest for the

individuals conducting it and is a topic with an adequate body of qualitative studies. The scope

of a meta-synthesis is an area of debate, with some qualitative researchers recommending a narrow,

precise approach and others recommending a broader, more inclusive approach. However,

researchers recognize that framing is essential for making the synthesis process manageable and

the findings meaningful and potentially transferable to practice. Usually the research question used

to direct the meta-synthesis process is identified in the synthesis report.

Denieffe and Gooney (2011) conducted their meta-synthesis based on the stages developed by

Sandelowski and Barroso (2007). These stages included “identifying a research question, collecting

relevant data (qualitative studies), appraising the studies, performing a metasummary and meta-

synthesis” (Denieffe & Gooney, 2011, p. 425). Denieffe and Gooney developed the following ques-

tion to direct their meta-synthesis and provided a rationale for their scope and focus:

“In this study the question was set as ‘What is the symptom experience of women with breast

cancer from time of diagnosis to completion of treatment?’ The time frame selected from time of

diagnosis to completion of treatment, has been conceptualized . . . as the ‘acute stage,’ encom- passing initial diagnosis and treatment in the first of a three-stage process of survivorship.”

Denieffe & Gooney, 2011, p. 425

? CRITICAL APPRAISAL BOX Guidelines for Critically Appraising Meta-Syntheses

1. Did the title of the report indicate that it was a meta-synthesis?

2. Did the report include an abstract of the purpose, clinical question addressed, meta-synthesis process

implemented, key findings, and implications for practice?

3. Did the authors clearly identify the purpose or focus of their meta-synthesis?

4. Was the meta-synthesis framed, and was a research question developed to direct the synthesis?

5. Did the authors conduct a systematic and comprehensive search for and retrieval of the qualitative studies in

the target area of inquiry?

6. Was the process for selecting studies for the meta-synthesis detailed?

7. Was the process for critically appraising the studies described?

8. Was a qualitative metasummary conducted as part of the meta-synthesis?

9. Did the authors discuss the analysis and interpretation of the findings from the qualitative studies?

10. Were the findings from the meta-synthesis clearly presented, including the themes identified and/or a

model or map of the overall findings?

11. Was the meta-synthesis report complete and concise? (Finfgeld-Connett, 2010; Higgins & Green, 2008;

Sandelowski & Barroso, 2007)?

438 CHAPTER 13 Building an Evidence-Based Nursing Practice

Searching the Literature and Selecting Sources

Most authors agree that a rigorous search of the literature needs to be conducted. The search needs

to include databases, books and book chapters, and full reports of theses and dissertations.

Researchers often document the special search strategies they use to locate relevant qualitative

studies for their meta-synthesis. The search criteria need to be detailed in the synthesis report,

and the years of the search, keywords searched, and language of sources need to be discussed.

Meta-syntheses are usually limited to qualitative studies only and do not include mixed-method

studies (Walsh & Downe, 2005). Also, qualitative findings that have not been interpreted but

that are unanalyzed quotes, field notes, case histories, stories, or poems are usually excluded

(Finfgeld-Connett, 2010). The search process is usually very fluid, with the conduct of additional

computerized and hand searches used to identify more studies. Researchers need to document sys-

tematically the strategies that they used to search the literature and the sources found through these

different search strategies in their meta-synthesis publication.

The final selection of studies to include in the meta-synthesis depends on the focus and scope of

the synthesis. Some authors focus on one type of qualitative research, such as ethnography, or on

one investigator in a particular area. Others include studies with different qualitative methodol-

ogies and investigators in a field or related fields. The search criteria need to be consistently imple-

mented in determining the studies to be included and excluded in the synthesis. A flow diagram

might be developed to identify the process for selecting studies similar to the one identified for

systematic reviews and meta-analyses (see Figure 13-1; Sandelowski & Barroso, 2007). Denieffe

and Gooney (2011) provided the following description of their literature search, search criteria,

and selection of studies for their meta-synthesis:

“Relevant qualitative research studies were located and retrieved using computer searches in

CINAHL, PsychLIT, Academic Search Premier, Embase, and MEDLINE. The research reports

selected for this synthesis met the following inclusion criteria: (1) the study focused on women

with breast cancer; (2) there were explicit references to the use of qualitative research methods;

and (3) the study focused on women’s perspectives and experiences of symptoms with breast can-

cer. There were no restrictions related to the date the research was published. Keywords used were

breast cancer, experience, symptom, and symptom experience.. . . The search using electronic databases was supplemented by . . . footnote chasing using reference lists, citation searching, in addition to hand searching of journals, and consultation with clinical colleagues and

researchers in the area. A total of 253 studies were identified as being possibly relevant. . . . Only 31 studies were found to be relevant to the research question and included in the meta-synthesis.

Reasons for this reduction included papers that provided limited qualitative data. . . . did not address the research question. . . . addressed post-treatment/survivor concerns.. . . or data given may not have related to patients with breast cancer.”

Denieffe & Gooney, 2011, pp. 425-426

Appraisal of Studies and Analysis of Data

The critical appraisal process for qualitative research varies among sources. Usually a table is devel-

oped as part of the appraisal process, but this is also an area of debate because tables of studies are

included more often in syntheses of quantitative studies. The table headings might include (1)

author and year of source, (2) aim or goal of the study, (3) theoretical orientation, (4) method-

ological orientation, (5) type of findings, (6) sampling plan, (7) sample size, and (8) other key

content relevant for comparison. This table provides a display of relevant study elements so that

a comparative appraisal might be conducted (Sandelowski & Barroso, 2007; Walsh & Downe,

439CHAPTER 13 Building an Evidence-Based Nursing Practice

2005). The comparative analysis of studies involves examining methodology and findings across

studies for similarities and differences. The frequency of similar findings might be recorded. The

differences or contradictions in studies need to be resolved, explained, or both. Varied analysis

techniques often are used by the researchers to translate the findings of the different studies into

a new or unique description.

Denieffe and Gooney (2011) developed a detailed comparative analysis table of the 31 studies

that they included in their meta-synthesis. Their table included the headings mentioned in the

previous paragraph as well as time frame from diagnosis, treatment, age range, and ethnic origin.

They indicated that the “final stage of data analysis was the qualitative meta-synthesis, interpreting

the findings. Constant targeted comparison within and between study findings was undertaken,

utilizing external literature to facilitate interpretation of the emerging findings” (Denieffe &

Gooney, 2011, p. 426).

Discussion of Meta-Synthesis Findings A meta-synthesis report might include findings presented in different formats based on the knowl-

edge developed and the perspective of the authors. A synthesis of qualitative studies in one area

might result in the discovery of unique or more refined themes explaining the area of synthesis.

The findings from a meta-synthesis might be presented in narrative format or graphically pre-

sented in a model or map. The discussion of findings also needs to include identification of

the limitations of the meta-synthesis. The report often concludes with recommendations for fur-

ther research and possibly implications for practice or policy development or both.

The synthesis by Denieffe and Gooney (2011) of 31 qualitative studies in the area of

symptoms experienced by women with breast cancer resulted in the identification of four emerging

themes: (1) breast cancer and the impact on self; (2) self-image and stigma; (3) self and self-

control; and (4) more than just a symptom. The researchers linked each of these themes with

the appropriate studies and presented this information clearly in a table. They also developed a

detailed model that linked the themes about self to the diagnosis and treatment of the women

and the symptoms they experienced (Figure 13-5). The following provides the conclusions from

this meta-synthesis:

“The overarching idea emerging from this meta-synthesis is that the symptoms experience for

women with breast cancer has effects on the very ‘self’ of the individual. Emerging is women’s

need to consider the existential issues that they face while simultaneously dealing with a mul-

titude of physical and psychological symptoms. This meta-synthesis develops a new, integrated,

and more complete interpretation of findings on the symptom experience of women with breast

cancer. The results offer the clinician a greater understanding in depth and breadth than the

findings from individual studies on symptom experiences.”

Denieffe & Gooney, 2011, p. 424

Critically Appraising Mixed-Methods Systematic Reviews In recent years, nurse researchers have been conducting mixed-methods studies that include quan-

titative and qualitative research methods (Creswell, 2014; Grove et al., 2013) (see Chapter 8 for a

discussion of mixed-methods designs). Researchers recognize the importance of synthesizing the

findings of these studies to determine important knowledge for practice and policy development.

For some synthesis areas, researchers need to combine the findings from quantitative and

qualitative studies to determine the current knowledge in that area. Harden and Thomas

(2005) identified this process of combining findings from quantitative and qualitative studies

440 CHAPTER 13 Building an Evidence-Based Nursing Practice

as mixed-methods synthesis. Higgins and Green (2008) referred to this synthesis of quantitative,

qualitative, and mixed-methods studies as a mixed-methods systematic review.

The systematic reviews discussed earlier in this chapter included only studies of a quantitative

methodology, such as meta-analyses, RCTs, and quasi-experimental studies, to determine the

effectiveness of an intervention. Mixed-methods systematic reviews might include various study

designs, such as qualitative research and quasi-experimental, correlational, and descriptive quan-

titative studies (Bettany-Saltikov, 2010b; Higgins & Green, 2008; Liberati et al., 2009). Reviews that

include syntheses of various quantitative and qualitative study designs are referred to as mixed-

methods systematic reviews in this text.

Mixed-methods systematic reviews involve a complex synthesis process that includes expertise

in synthesizing knowledge from quantitative, qualitative, and mixed-methods studies. Higgins and

Green (2008) described two types of approaches to integrate the findings from quantitative, qual-

itative, and mixed-methods studies, (1) multilevel synthesis and (2) parallel synthesis. Multilevel

synthesis involves synthesizing the findings from quantitative studies separately from qualitative

studies and integrating the findings from these two syntheses in the final report. Parallel synthesis

involves the separate synthesis of quantitative and qualitative studies, but the findings from the

qualitative synthesis are used in interpreting the synthesized quantitative studies.

Further work is needed to develop the methodology for conducting a mixed-methods system-

atic review. The steps overlap with those of the systematic review and meta-synthesis processes

described earlier. The process might best be implemented with a team of researchers with expertise

in conducting different types of studies and research syntheses. Guidelines for critically appraising

mixed-methods systematic reviews are presented in the box that follows.

Symptom Experience of Women with Breast Cancer

Pre-diagnosis

Time of Diagnosis

Anticipations of Treatment

Initiation of Treatment

Leaving Active Treatment

Post Treatment

Self Loss of Control and Autonomy

Stigma

Self-Image

Existential Issues

Change in Roles

Pain

Fatigue

Anxiety

Depression

Hair loss

Skin changes

Weight Gain

Eating and Drinking

Nausea and Vomiting

Smell and Taste Changes

Sexual Problems

Menopause / Fertility Problems

T im

e E

v e n

t L

in e

S y m

p to

m s

Surgery

Chemotherapy

Radiotherapy

Hormone therapy

FIG 13-5 Overall findings of a meta-synthesis. (From Denieffe, S., & Gooney, M. (2011). A meta- synthesis of women’s symptoms experience and breast cancer. European Journal of Cancer Care, 20(4), 430.)

441CHAPTER 13 Building an Evidence-Based Nursing Practice

Wulff, Cummings, Marck, and Yurtseven (2011) conducted a mixed-methods systematic review

to examine the association of medication administration technologies and patient safety. The title

indicated that a mixed-method systematic review was conducted. The abstract clearly and con-

cisely covered the aim of the review, search process, review methods, results, and conclusions.

Wolff and associates (2011, p. 2080) noted that “the aim of the study was to evaluate the research

evidence on relationships between the use of medication administration technologies and inci-

dence of medication administration incidents and preventable adverse drug events to inform

decision-making about existing technology options.” The authors systematically searched 13 data-

bases with keywords such as medication, drugs, pharm system, medication errors, and safety.

A total of 37,705 titles and abstracts were screened, and 108 full-text manuscripts were retrieved

and reviewed.

Wulff and co-workers (2011) presented a flow chart to document the selection of the 12 man-

uscripts included in the mixed-methods systematic review. These 12 studies included the following

designs: five preintervention and postintervention studies, five correlational studies, and two qual-

itative studies. The elements of the 12 studies were compared in two different tables. The tables

included the study source, medication technology intervention studied, setting, sample size, study

design, outcomes measured, and results. Most of the healthcare agencies measured short-term out-

comes focused on medication errors, with less focus on adverse drug events and patient safety out-

comes. The authors recognized the publication bias of only reviewing titles and abstracts in

English. The studies reviewed mainly reported positive findings, with less coverage of negative

and nonsignificant findings, which is another publication bias.

The major focus of this review was the synthesis of the 10 quantitative studies that identified the

benefits of implementing medication administration technologies to improve patient safety. How-

ever, the problem identified by the quantitative and qualitative studies was that nurses develop

workarounds when implementing different types of medication administration technologies,

which could compromise patient safety. Wulff and colleagues (2011) recommended that additional

intervention studies be conducted with a framework, hypotheses, and experimental or RCT

designs to produce stronger, evidence-based knowledge for practice. This knowledge is essential

? CRITICAL APPRAISAL GUIDELINES Guidelines for Critically Appraising Mixed-Methods Systematic Reviews

1. Did the title identify the type of research synthesis that was conducted?

2. Was a clear, concise abstract presented that included the purpose, clinical question addressed, data

sources, review methodology, results, findings, and recommendations for practice?

3. Were the purpose and questions guiding the mixed-methods systematic review identified?

4. What were the search criteria for quantitative, qualitative, and mixed-methods studies?

5. Were the search strategies identified for locating relevant quantitative, qualitative, and mixed-methods

studies?

6. Was a rigorous search of the literature conducted and detailed in the final report?

7. Was the process for selecting relevant quantitative, qualitative, and mixed-methods studies for the synthe-

sis detailed?

8. Was a table of information of studies included that demonstrated a comparative appraisal of the studies?

9. Were critical appraisals of the studies summarized in the final report?

10. Was a clear synthesis of study findings presented? Did this synthesis integrate the findings from quanti-

tative, qualitative, and mixed-method studies? (Bettany-Saltikov, 2010a, 2010b; Creswell, 2014; Higgins &

Green, 2008)

442 CHAPTER 13 Building an Evidence-Based Nursing Practice

to guide the selection and use of medication administration technologies in healthcare agencies to

promote patient safety, which is a QSEN (2013) competency area.

DEVELOPING CLINICAL QUESTIONS TO IDENTIFY EXISTING RESEARCH-BASED EVIDENCE FOR USE IN PRACTICE

EBP requires using the most current research evidence in practice. Many research-based protocols,

algorithms, and guidelines have been published for nurses to use in their practice. Thousands of

research syntheses (systematic reviews, meta-analyses, meta-syntheses, and mixed-methods sys-

tematic reviews) are available through libraries and national and international organizations

and collections. Many individual studies in selected areas require identification, review, and sum-

marizing for use in practice (see Chapter 6). Students and practicing nurses need to use this current

research evidence in practice (see Table 13-1 for resources that include current research evidence).

Use of current best research evidence in practice is usually organized by a relevant clinical question

formulated using the PICO format. The PICO format is very similar to the PICOS format intro-

duced earlier to guide systematic reviews and meta-analyses. However, the PICO format is also

implemented to organize research evidence to address a clinical problem.

P—Population or participants of interest in your clinical setting

I—Intervention needed for practice

C—Comparisons of interventions to determine the best intervention for your practice

O—Outcomes needed for practice and ways to measure the outcomes in your practice

You can use the PICO format to identify relevant studies, meta-analyses, and integrative

reviews needed to develop evidence-based protocols, algorithms, guidelines, and policies for

practice. Some publications include a systematic review and guidelines for practice. For exam-

ple, Nicoll and Hesby (2002) developed a systematic review of the research literature focused on

intramuscular (IM) injection techniques. This review provided the basis for their development

of a clinical practice guideline entitled “Intramuscular Injection: Guidelines for Evidence-Based

Technique.” The goal of their systematic review and evidence-based guidelines was the “elimi-

nation of complications from IM injections” (Nicoll & Hesby, 2002, p. 152). The researchers

summarized the medications routinely administered by the IM route with site recommendations

in Table 13-3. This table includes the medication class, generic and brand names of the med-

ication, and recommended site and needle size for selected IM injections. The recommendations

for sites and needle size (length and gauge) were for infants, toddlers, and adults. This is valu-

able research evidence for you to use when giving an IM injection of a particular medication to

patients of all ages in your practice (Cocoman & Murray, 2008; Greenway, 2004). Table 13-4

presents the clinical practice guideline for giving IM injections using an evidence-based

technique.

You can use the PICO format to determine the evidence-based delivery of an IM injection.

P—Population is adults needing influenza virus vaccine by IM injection. Confirm that the vaccine

must be given by IM injection.

I—Intervention to deliver the right medication by the right route at the right site using the appro-

priate needle size (length and gauge; Cocoman & Murray, 2008; Greenway, 2004).

C—Comparison of interventions reveals that influenza virus vaccine should be given to adults in

the deltoid site with 25- to 38-mm, 22- to 25-gauge needles (see Table 13-3). The evidence-

based technique for giving the IM injection is given in Table 13-4.

O—Outcome desired is an IM injection of vaccine without complications.

443CHAPTER 13 Building an Evidence-Based Nursing Practice

TABLE 13-3 MEDICATIONS ROUTINELY ADMINISTERED BY THE INTRAMUSCULAR ROUTE WITH SITE RECOMMENDATIONS

MEDICATION

CLASS GENERIC NAME

BRAND

NAMES

(SELECTED)*

RECOMMEND SITES AND

NEEDLE SIZE{

Antibiotics Streptomycin sulfate Streptomycin

sulfate

injection

Adults—ventrogluteal (VG) with

38-mm, 18- to 25-gauge needle

Infants and young children—vastus

lateralis with 16- to 25-mm, 22- to

25-gauge needle

Penicillin G benzathine,

penicillin G procaine

Bicillin, Wycillin,

Pfizerpen

Biologicals,

including immune

globulins,

vaccines, and

toxoids

Diphtheria and tetanus

toxoids adsorbed

DT (pediatric),

Td (adult)

Adults—deltoid with 25- to 38-mm,

22- to 25-gauge needle Hepatitis

B and rabies must be given in the

deltoid site. Immune globulin may

be given in the deltoid (volumes

of 2 mL or less) or VG site (volumes

of >2 mL).

Toddlers and older children— deltoid,

if the muscle mass is adequate, with

16- to 32-mm, 22- to 25-gauge

needle

Infants, young children, and those

with inadequate muscle mass at the

deltoid site—vastus lateralis with

22- to 25-mm, 22- to 27-gauge

needle

Diphtheria, tetanus, and

acellular pertussis

Acel-Immune,

Infanrix,

Tripedia,

Certiva

Haemophilus influenzae

type b conjugate

ActHIB

Haemophilus influenzae

type b conjugate and

hepatitis B

(recombinant)

Comvax

Hepatitis A vaccine,

inactivated

Havrix, Vaqta

Hepatitis B vaccine

(recombinant)

Engerix-B,

Recombivax

HB

Hepatitis B immune

globulin (human)

BayHep B,

Nabi-HB

Hepatitis A inactivated

and hepatitis B

(recombinant)

Twinrix

Immune globulin for pre-

and postexposure

prophylaxis for hepatitis

A infection

Influenza virus vaccine Fluogen,

FluShield,

Fluvirin,

Fluzone

Lyme disease vaccine LYMErix

Pneumococcal vaccine,

polyvalent

Prevnar

Rabies vaccine, adsorbed RabAvert

Rabies immune globulin

(human)

Rho(D) immune globulin

(human)

BayRho-D,

MICRhoGAM,

RhoGAM,

WinRho SDF

444 CHAPTER 13 Building an Evidence-Based Nursing Practice

TABLE 13-3 MEDICATIONS ROUTINELY ADMINISTERED BY THE INTRAMUSCULAR ROUTE WITH SITE RECOMMENDATIONS—cont’d

MEDICATION

CLASS GENERIC NAME

BRAND

NAMES

(SELECTED)

RECOMMEND SITES AND

NEEDLE SIZE

Tetanus immune globulin

(human)

BayTet

Tetanus toxoid, adsorbed Tetanus Toxoid,

Adsorbed,

Purogenated

Hormonal agents Medroxyprogesterone

acetate

Depo-Provera Adults—VG with 38- mm, 18- to

25-gauge needle (these

medications typically not indicated

for infants and young children)

Chorionic gonadotropin Novarel, Pregnyl

Menotropin Humegon,

Repronex

Testosterone enanthate Delatestryl

*Selected brand names are included to be illustrative of products widely used in the United States; in other countries in

which the generic products are available (this is particularly true in the case of vaccines), they may go by different names. All

brand names are copyrighted trademarks of their respective companies. {Needle sizes are provided in metric lengths to conform to the international standard; for U.S. readers, corresponding needle

sizes in inches are as follows: 16 mm¼5 � 8”; 22 mm¼7

� 8”; 25 mm¼1”; 32 mm¼1 1

� 4”; 38 mm¼1 1

� 2”.

(From Nicoll, L. H., & Hesby, A. (2002). Intramuscular injection: An integrative research review and guideline for evidence-

based practice. Applied Nursing Research, 16(2), 150.)

TABLE 13-4 CLINICAL PRACTICE GUIDELINE

Intramuscular Injection Guidelines for Evidence-Based Technique

Patient Population

Infants, toddlers, children, and adults receiving medication by the IM route for curative or prophylactic purposes

Objective

Administration of medication to maximize its therapeutic effect for the patient and minimize or eliminate patient

injury and discomfort associated with the procedure

Key Points

“An injection should only be given if it is necessary—and each injection that is given must be safe” (WHO, 1998).

Justification for IM injection. Consider:

• Medication characteristics, including formulation, onset and intensity of effect, and duration of effect*

• Patient characteristics, including compliance, uncooperativeness, reluctance, or inability to take medication

via another route*

Site selection. Site is the single most consistent factor associated with complications and injury. Consider:

Age of patient:

• Infants—vastus lateralis is the preferred site.*

• Toddlers and children—vastus lateralis or deltoid*

• Adults—ventrogluteal or deltoid*

Medication type

• Biologicals (including immune globulins, vaccines, and toxoids)—vastus lateralis (infants and young

children); deltoid in older children and adults*

Continued

445CHAPTER 13 Building an Evidence-Based Nursing Practice

TABLE 13-4 CLINICAL PRACTICE GUIDELINE—cont’d

• Hepatitis B and rabies must be given in the deltoid; injection in other sites decreases the immunogenicity of

the medication.

• Depot formulations—ventrogluteal site*

• Medications that are known to be irritating, viscous or in oily solutions should be administered at the

ventrogluteal site.*

Medication volume

• Small volumes of medication (�2 mL) may be given in the deltoid site.* • Large volumes of medication (2-5 mL) should be given in the ventrogluteal site.

Always use bony landmarks to identify the site properly *

Preparation of the medication. Consider:

Equipment

Needle length corresponds to the site of injection and age of patient according to the following guidelines:

• Vastus lateralis—16 mm to 25 mm*

• Deltoid (children)—16 mm to 32 mm*

• Deltoid (adults)—25 mm to 38 mm*

• Ventrogluteal (adults)—38 mm*

Needle gauge—often dependent on needle length. In general, most biologicals and medications in aqueous

solutions can be administered with a 20- to 25-gauge needle; medications in oil-based solutions require 18- to

25-gauge needles{

Always use a new, sterile syringe and needle for every injection.*

Use a filter needle to withdraw medication from a glass ampule* or rubber-topped vial.}

With a filter needle, change needle before injection.*

Use the markings on the syringe barrel to determine the correct dose.*

Do not include an air bubble in the syringe*

Patient preparation and positioning. Consider site of injection:

• Deltoid—patient may sit or stand.{ A child may be held in an adult’s lap.*

• Ventrogluteal—patient may stand, sit, or lay laterally or supine.*

• Vastus lateralis—infants and young children may lay supine or be held in an adult’s lap.*

• Remove clothing at the site for adequate visualization and palpation of bony landmarks.{

• Position patient to relax the muscle.*

Injection procedure

• Cleanse the site with alcohol and allow to dry. {

• Insert needle into the muscle using a smooth, steady motion.{

• Research on two alternate techniques to reduce pain at the moment of injection is inconclusive at this time,

but warrants further study.{,}

• Aspirate for 5 to 10 seconds.*

• Inject slowly at a rate of 10 sec/mL. {

• After injection, wait 10 seconds before withdrawing the needle.{

• Withdraw needle slowly; apply gentle pressure with a dry sponge. {

Postinjection

• Assess site for complications, immediately and 2 to 4 hours later, if possible.

• Instruct patient regarding assessment, self-management of minor reactions, and when to report more serious

problems.*

• Properly and promptly dispose of all equipment.*

Note. Needle sizes are provided in metric lengths to conform to international standard; for U.S. readers, corresponding

needle sizes in inches are as follows: 16 mm¼5 � 8”; 22 mm¼7

� 8”; 25 mm¼1”; 32 mm¼11

� 4”; 38 mm¼11

� 2”.

Criteria for grading of the evidence:

*Empirical data from published research reports, recommendations of established advisory panels, and generally accepted

scientific principles. {Surveys, reviews, consensus among clinicians, and expert opinion. { Published case reports.

} Anecdotal evidence and letters.

From Nicoll, L. H., & Hesby, A. (2002). Intramuscular injection: An integrative research review and guideline for evidence-

based practice. Applied Nursing Research, 16(2), 159.

You can use Tables 13-3 and 13-4 to ensure that you give IM injections using the best research

evidence available. You can then share this evidence with others in clinics, hospitals, or rehabili-

tation centers to promote EBP for the delivery of IM injections (QSEN, 2013).

MODELS TO PROMOTE EVIDENCE-BASED PRACTICE IN NURSING

EBP is a complex phenomenon that requires integration of the best research evidence with clinical

expertise and patient values and needs in the delivery of quality, cost-effective care. The two models

most commonly used to implement research evidence in practice are the Stetler Model of Research

Utilization to Facilitate Evidence-Based Practice (Stetler, 2001) and the Iowa Model of Evidence-

Based Practice to Promote Quality of Care (Titler et al., 2001). These two models are discussed in

this section.

Stetler Model of Research Utilization to Facilitate Evidence-Based Practice An initial model for research utilization in nursing was developed by Stetler and Marram in 1976

and expanded and refined by Stetler in 2001 to promote EBP for nursing. The Stetler Model of

Research Utilization to Facilitate Evidence-Based Practice (Figure 13-6) provides a comprehen-

sive framework to enhance the use of research evidence by nurses to facilitate an EBP. The research

evidence can be used at the institutional or individual level. At the institutional level, study findings

PHASE I: PREPARATION

Affirm priority

Consider influential factors

PHASE II: VALIDATION

PHASE III: COMPARATIVE EVALUATION/DECISION MAKING

Define purpose and outcomes per

issue/catalyst

Search, sort, and select sources of research evidence

Perform utilization focused critique and synopsis: Identify and, if applicable, record key study details and qualifiers

Accept Reject

Stop

Synthesize findings and evaluate per

criteria

Substan- tiating evidence

State decision/s re: use of findings,

per strength of evidence: A. Not use = Stop

B. Use now

B′. Consider use

A. Confirm type, level, and method of application,

per details in part II

B. Use: Review operational details

• Formally: Identify design evidence-based document/s; package for dissemination; as needed, develop E-B change plan, including evaluation

• Informally: Use in practice

B´. Consider use:

• Informally: Obtain targeted practice information; evaluate • Formally: Do formal details as in B; plan/implement a pilot "use" project, with evaluation • Per results, accept and extend, with or without modification, OR if reject = Stop

PHASE IV: TRANSLATION/APPLICATION

Evaluate dynamically: 1. Identify goal for each “use” 2. Obtain evidence re: change process and goal-related progress, as well as any results/outcomes 3. Use iterative evidence to achieve goals

Evaluate as part of routine practice

PHASE V: EVALUATION

Fit of setting

Feasibility (r,r,r)

Current practice

OR

FIG 13-6 Stetler Model, Part I. Shown are the steps of research utilization to facilitate EBP. (From Stetler, C. B. (2001). Updating the Stetler model of research utilization to facilitate evidence-based practice. Nursing Outlook, 49(6), 276.)

447CHAPTER 13 Building an Evidence-Based Nursing Practice

are synthesized and the knowledge generated is used to develop or refine policies, algorithms, pro-

cedures, protocols, or other formal programs implemented in the institution. Individual nurses,

such as RNs, educators, and policymakers, summarize research and use the knowledge to make

practice decisions, influence educational programs, and guide political decision making. For

example, the evidence-based guidelines for giving IM injections discussed in the previous section

can be implemented at the individual level to promote quality outcomes for IM injections given by

nurses.

Stetler’s model is included in this text to encourage the use of research evidence by individual

nurses and healthcare institutions to facilitate the development of EBP. The five phases of the

Stetler (2001) model are briefly described in the following sections: (1) preparation, (2) validation,

(3) comparative evaluation and decision making, (4) translation and application, and (5)

evaluation.

Phase I: Preparation The intent of Stetler’s (2001) model is to make using research evidence in practice a conscious,

critical thinking process that is initiated by the user. Thus, Phase I: Preparation, involves deter-

mining the purpose, focus, and potential outcomes of making an evidence-based change in a clin-

ical agency. Agency priorities and other external and internal factors that could be influenced by or

could influence the proposed practice change need to be examined. Once the agency, individuals,

or committee identify and approve the purpose of the evidence-based project, a detailed search of

the literature is conducted to determine the strength of the evidence available for use in practice

(see Chapter 6 for directions in searching the literature). The research literature might be reviewed

to solve a difficult clinical, managerial, or educational problem; provide the basis for a policy, algo-

rithm, or protocol; or prepare for an in-service program or other type of professional presentation.

Phase II: Validation In Phase II: Validation, the research reports are critically appraised to determine their scientific

soundness (Fawcett & Garity, 2009; Hoare & Hoe, 2013; Hoe & Hoare, 2012). If the studies are

limited in number, weak, or both, the findings and conclusions are considered inadequate for

use in practice and the process stops. If a systematic review, meta-analysis, and/or meta-synthesis

have been conducted in the area in which you want to make an evidence-based change, this greatly

strengthens the quality of the research evidence. If the research knowledge base is strong in the

selected area, the clinical agency must make a decision regarding the priority of using the evidence

in practice.

Phase III: Comparative Evaluation/Decision Making

Phase III: Comparative Evaluation includes four parts: (1) substantiation of the evidence; (2) fit

of the evidence with the healthcare setting; (3) feasibility of using research findings; and (4) con-

cerns with current practice (see Figure 13-6). Substantiating evidence is produced by replication, in

which consistent, credible findings are obtained from several studies in similar practice settings.

The studies generating the strongest research evidence are systematic reviews and meta-analyses of

RCTs. However, quasi-experimental studies also provide extremely strong evidence for making a

change in an agency. To determine the fit of the evidence in the clinical agency, examine the char-

acteristics of the setting to determine the forces that will facilitate or inhibit implementation of the

evidence-based change, such as a policy, protocol, or algorithm, for nursing practice. Stetler (2001)

believes that the feasibility of using research evidence in practice involves examining the three Rs

related to making changes in practice: (1) potential risks, (2) resources needed, and (3) readiness of

448 CHAPTER 13 Building an Evidence-Based Nursing Practice

those involved. The final comparison involves determining whether the research information pro-

vides credible, empirical evidence for making changes in the current practice. The research evi-

dence needs to document that an intervention increased the quality in current practice by

solving practice problems and improving patient outcomes. By conducting phase III, you can

assess the overall benefits and risks of using the research evidence in a practice setting. If the ben-

efits are much greater than the risks for the organization, individual nurse, or both, using the

research-based intervention in practice is feasible.

During the decision-making aspect of phase III, three decisions are possible: (1) to use the

research evidence; (2) to consider using the evidence; and (3) not to use the research evidence

(see Figure 13-6). The decision to use research knowledge in practice depends mainly on the

strength of the evidence. Depending on the research knowledge to be used in practice, the indi-

vidual RN, hospital unit, or agency might make this decision. Another decision might be to con-

sider use of the available research evidence in practice. When a change is complex and involves

multiple disciplines, additional time is often needed to determine how the evidence might be used

and what measures will be taken to coordinate the involvement of different healthcare profes-

sionals in the change. A final option might be not to use the research evidence in practice because

the current evidence is not strong, or the risks or costs of change in current practice are too high in

comparison with the benefits (Stetler, 2001).

Phase IV: Translation/Application Phase IV: Translation/Application involves planning for and actual use of the research evidence in

practice. The translation phase involves determining exactly what knowledge will be used and how

that knowledge will be applied to practice. The use of the research evidence can be cognitive, instru-

mental, or symbolic. With cognitive application, the research base is a means of modifying a way of

thinking or one’s appreciation of an issue (Stetler, 2001). For example, cognitive application may

improve the nurse’s understanding of a situation, allow analysis of practice dynamics, or improve

problem-solving skills for clinical problems. Instrumental application involves using research evi-

dence to support the need for change in nursing interventions or practice protocols. Symbolic or

political utilization occurs when information is used to support or change a current policy. The

application phase includes the following steps for planned change: (1) assess the situation to be

changed; (2) develop a plan for change; and (3) implement the plan. During the application

phase, the protocols, policies, or algorithms developed with research knowledge are implemented

in practice (Stetler, 2001). An agency may conduct a pilot project on a single hospital unit to imple-

ment the change in practice. The agency would then evaluate the results of this project to determine

if the change should be extended throughout the healthcare agency.

Phase V: Evaluation The final stage, Phase V: Evaluation, is to evaluate the impact of the research-based change on the

healthcare agency, personnel, and patients. The evaluation process can include formal and infor-

mal activities conducted by administrators, nurse clinicians, and other health professionals. Infor-

mal evaluations might include self-monitoring or discussions with patients, families, peers, and

other professionals. Formal evaluations can include case studies, audits, quality improvement,

and translational or outcomes research projects. The goal of Stetler’s (2001) model is to increase

the use of research evidence in nursing to facilitate EBP. This model provides detailed steps to

encourage nurses to become change agents to make the necessary improvements in practice based

on research evidence.

449CHAPTER 13 Building an Evidence-Based Nursing Practice

Iowa Model of Evidence-Based Practice Nurses have been actively involved in conducting research, synthesizing research evidence, and

developing evidence-based guidelines for practice. These activities support their strong commit-

ment to EBP, which could be facilitated by the Iowa model. The Iowa Model of Evidence-Based

Practice provides direction for the development of EBP in a clinical agency. This EBP model was

initially developed by Titler and associates in 1994 and revised in 2001 (Figure 13-7). In a health-

care agency, there are triggers that initiate the need for change, and the focus should always be to

make changes based on the best research evidence. These triggers can be problem-focused and

evolve from risk management data, process improvement data, benchmarking data, financial data,

and clinical problems. The triggers can also be knowledge-focused, such as new research findings,

change in national agencies or organizational standards and guidelines, expanded philosophy

of care, or questions from the institutional standards’ committee. The triggers are evaluated

and prioritized based on the needs of the clinical agency. If a trigger is considered an agency pri-

ority, a group is formed to search for the best evidence to manage the clinical concern (Titler

et al., 2001).

In some situations, the research evidence is inadequate to make changes in practice, and addi-

tional studies are needed to strengthen the knowledge base. Sometimes the research evidence can

be combined with other sources of knowledge (e.g., theories, scientific principles, expert opinion,

and case reports) to provide fairly strong evidence for use in developing research-based protocols

for practice. Research-based protocols are structured guidelines for implementing nursing inter-

ventions in practice that are based on current research evidence. The strongest evidence comes

from systematic reviews that include meta-analyses of RCTs. However, meta-syntheses, mix-

methods systematic reviews, and individual studies also provide important evidence for changing

practice. The levels of research evidence are described in Chapter 1 (see Figure 1-3) and also pre-

sented inside the front cover of this text.

The research-based protocols or evidence-based guidelines developed could be pilot-tested on a

particular unit and then evaluated to determine the impact on patient care. If the outcomes are

favorable from the pilot test, the change would be made in practice and monitored over time to

determine its impact on the agency environment, staff, costs, and patient and family (Titler et al.,

2001). If an agency strongly supports the use of the Iowa model, implements patient care based on

the best research evidence, and monitors changes in practice to ensure quality care, the agency is

promoting EBP.

Application of the Iowa Model of Evidence-Based Practice Preparing to use research evidence in practice raises some important questions. Which research

findings are ready for use in clinical practice? What are the most effective strategies for implement-

ing research-based protocols or evidence-based guidelines in a clinical agency? What are the out-

comes from using the research evidence in practice? Do the risk management data, process

improvement data, benchmarking data, or financial data support making the change in practice

based on the research evidence? Is the research-based change proposed an agency priority? We sug-

gest that effective strategies for using research evidence in practice will require a multifaceted

approach that takes into consideration the evidence available, attitudes of the practicing nurses,

the organization’s philosophy, and national organizational standards and guidelines (ANCC,

2014; Brown, 2014; Melnyk & Fineout-Overholt, 2011; The Joint Commission, 2014). In this sec-

tion, the steps of the Iowa model (Titler et al., 2001) guide the use of a research-based intervention

in a hospital to facilitate EBP.

450 CHAPTER 13 Building an Evidence-Based Nursing Practice

Disseminate results

Monitor and analyze structure, process, and outcome data • Environment • Staff • Cost • Patient and family

Problem-focused triggers 1. Risk management data 2. Process improvement data 3. Internal/external benchmarking data 4. Financial data 5. Identification of clinical problem

Consider other

triggers

Pilot the change in practice 1. Select outcomes to be achieved 2. Collect baseline data 3. Design evidence-based practice (EBP) guideline(s) 4. Implement EBP on pilot units 5. Evaluate process and outcomes 6. Modify the practice guideline

Base practice on other types of evidence: 1. Case reports 2. Expert opinion 3. Scientific principles 4. Theory

Conduct research

Continue to evaluate quality of care and new knowledge

Institute the change in practice

Yes No

No Yes

No Yes

Knowledge-focused triggers 1. New research or other literature 2. National agencies or organizational standards and guidelines 3. Philosophies of care 4. Observation from institutional standards committee

Form a team

Assemble relevant research and related literature

Critique and synthesize research for use in practice

Is this topic a priority for the

organization?

Is there a sufficient research

base?

Is change appropriate for

adoption in practice?

FIG 13-7 Iowa Model of Evidence-Based Practice to Promote Quality of Care. (From Titler, M. G., Kleiber, C., Steelman, V. J., Rakel, B. A., Budreau, G., Everett, L. Q., et al. (2001). The iowa model of evidence-based practice to promote quality care. Critical Care Nursing Clinics of North America, 13(4), 497–509.)

Schumacher, Askew, and Otten (2013) used the Iowa model for EBP to implement a pres-

sure ulcer trigger tool for assessing the neonatal population in their hospital. Pressure ulcer

prevalence ranged from 0% to 1% per quarter in this large Midwest neonatal intensive care

unit (NICU). Schumacher and co-workers noted that no pressure ulcer risk assessment tool

was used consistently in their NICU. A summary of the application of the Iowa model of

EBP to this clinical problem is summarized in Table 13-5. The clinical question addressed

was generated using the PICO format. Population was the infants in the NICU. The interven-

tion to be implemented was a three-question pressure ulcer trigger tool to assess if the neonates

were at risk for skin breakdown. The comparison was with the Braden Q tool, the standard care

or usual practice of determining the neonates who were at risk for pressure ulcers (PUs).

The outcome measured was the effectiveness of the PU trigger tool as compared to the Braden

Q tool in assessing neonates who are at risk for PU. The studies that had examined the effec-

tiveness of different neonatal PU assessment tools were critically appraised. The tools in these

studies were judged to be too long for routine clinical use. Schumacher and colleagues (2013)

developed a shorter trigger assessment tool based on the research evidence: “Trigger Questions

for Pressure Ulcer Risk Proposed by the Institute for Clinical Systems Improvement: Is the

infant: Moving extremities and/or body appropriately for developmental age? Responding

to discomfort in a developmentally appropriate manner? Demonstrating adequate tissue per-

fusion based on the clinical formula (mean arterial pressure¼gestational age and/or capillary refill <3 s)?” (Schumacher et al., 2013, p. 48).

TABLE 13-5 USE OF THE IOWA MODEL FOR EVIDENCE-BASED PRACTICE PROJECTS TO ESTABLISH A CLINICAL TOOL FOR EVALUATION OF PRESSURE ULCER RISK IN AN NICU

1. Generate the question

from either a problem

or new knowledge.

For infants in the NICU, does the use of a pressure ulcer trigger tool perform

equally as well as the Braden Q to identify an infant at risk?

P—Infant in the NICU

I—Use of a pressure ulcer trigger tool

C—Usual practices of assessing all with Braden Q

O—Trigger tool performs equally as well as the Braden Q for risk identification

2. Determine relevance to

organizational priorities.

Our hospital is committed to safe and reliable care and ensuring a flawless

patient experience. This includes preventing hospital-acquired pressure

ulcers—a “never event.” Possible impact/outcomes may include:

• Potential increase in WOC referrals

• Correct triggering of infants requiring further pressure ulcer risk assessment

and prevention strategies by nursing

• Preservation of nursing time because the trigger tool is a shorter and easier to

use tool that indicates for whom full assessment is needed.

3. Develop a team to gather

and appraise evidence.

Team members included a clinical nurse specialist, two WOC nurses, NICU

Nursing Practice Council members, and electronic medical records experts.

According to IHI, all premature infants are at risk for pressure ulcer development.

Although this statement is visionary, it does not assist the bedside nurse to

determine for whom to provide interventions. Referrals to the WOC nurse for

assessment were based on clinical judgment, and no assessment tools were

in place. Risk assessment tools are available for the neonatal population but

were judged to be lengthy and time-consuming for every nurse, every shift.

A trigger tool was developed, based on IHI pediatric trigger questions to help

the nurse determine whom to refer for full assessment.

452 CHAPTER 13 Building an Evidence-Based Nursing Practice

Schumacher and associates (2013) found that their three-question PU trigger assessment tool

was as effective as the Braden Q tool in determining neonatal risk for pressure ulcers. Their findings

are summarized in the following study excerpt:

“Following implementation ofthetriggerquestionsin2009,we observednonetincreaseinthenum-

ber of WOC [wound, ostomy, and continence] referrals per 1000 patients. Nevertheless, our PU

[pressure ulcer] prevalence in the NICU remains low at 0.01 per 1000 patient days. Comparison

of results from the 3 trigger questions and the Braden Q scoring by the WOC nurse demonstrated

that most infants are correctly identified by the tool, with the exception of those very immature

infants who may be at risk for medical device-related ulcers. . .. We implemented a 3-item trigger tool to aid NICU nurses identifying neonates at risk for PU

development. While these questions do not quantify risk, we have found that they are an efficient

initial screening tool when combined with additional assessment and management in consul-

tation with a WOC nurse.”

Schumacher et al., 2013, p. 50

IMPLEMENTING EVIDENCE-BASED GUIDELINES IN PRACTICE

EBP in nursing and medicine has expanded extensively since the 1990s. Research knowledge is

generated every day that needs to be critically appraised and synthesized to determine the best

evidence for use in practice (Brown, 2104; Craig & Smyth, 2012; Melnyk, Fineout-Overholt,

Stillwell, & Williams, 2010). This section discusses the evidence-based guidelines developed based

TABLE 13-5 USE OF THE IOWA MODEL FOR EVIDENCE-BASED PRACTICE PROJECTS TO ESTABLISH A CLINICAL TOOL FOR EVALUATION OF PRESSURE ULCER RISK IN AN NICU—cont’d

4. Determine if the evidence

answers the question.

Reasonable evidence is present to warrant implementation of this practice.

The three IHI trigger questions are based on the concepts of the Braden Q and

could trigger those at risk and requiring further assessment and intervention.

5. If there is sufficient

evidence, pilot the

change in practice.

Prior to implementation, 10 patients were randomly selected to test the

feasibility of implementing trigger questions. The three trigger questions were

asked of the nurses caring for each patient, and results were compared to a

Braden Q score generated by a WOC nurse. We noted that patients with high

risk, as defined by the Braden Q, were also identified as at-risk based on the

three trigger questions. The three trigger questions were embedded into

the electronic medical record.

Pressure ulcer data were collected through the surveillance provided by skin

team nurses as part of their usual duties.

6. Evaluate structure,

process, and outcome

data.

The HAPU rate for the NICU remains low and has not changed since the

implementation of the trigger tool. The number of WOC nurse consultations

has remained stable since implementation of the three trigger questions into

NICU nurse practice.

7. Disseminate results. Results and appropriate feedbacks have been shared with the NICU nurses via

the NICU practice

HAPU, Hospital-acquired pressure ulcer; IHI, Institute for Healthcare Improvement; NICU, neonatal intensive care unit;

WOC, Wound, ostomy, and continence.

From Schumacher, B., Askew, M., & Otten, K. (2013). Development of a pressure ulcer trigger tool for the neonatal

population. Journal of Wound, Ostomy, and Continence Nursing, 40(1), Table 1, p. 47.

453CHAPTER 13 Building an Evidence-Based Nursing Practice

on the current, best research evidence available by expert researchers and clinicians for use in prac-

tice. For example, Chobanian and co-workers (2003) conducted an excellent systematic review to

determine the best research evidence available for assessing, diagnosing, and managing hyperten-

sion (HTN). This systematic review, which included several meta-analyses, was used to develop the

“Seventh Report of the Joint National Committee on Prevention, Detection, and Treatment of

High Blood Pressure” (JNC 7; National Heart, Lung, and Blood Institute [NHLBI], 2003). The

JNC 7 guideline for the management of HTN, introduced in Chapter 1, is the currently recognized

guideline by the NHLBI. James and colleagues (2014; panel members appointed to the Eighth Joint

National Committee [JNC 8]) released 2014 Evidence-Based Guideline for the Management of

High Blood Pressure in Adults, but the guideline is not affiliated with NHLBI or any other orga-

nization. In January of 2014, the American Society of Hypertension and the International Society

of Hypertension released clinical practice guidelines for the management of hypertension in the

community (Weber et al., 2014). The JNC 7 and the most recent guidelines by the American

and International Societies of Hypertension (Weber et al., 2014) are presented as an example later

in this section.

History of the Development of Evidence-Based Guidelines Since the 1980s, the Agency for Healthcare Research and Quality (AHRQ) has had a major role in

identifying health topics and developing evidence-based guidelines for these topics (http://www.

ahrq.gov). In the late 1980s and early 1990s, panels or teams of experts were often charged with devel-

oping clinical guidelines for the AHRQ. The AHRQ solicited the members of the panel, who usually

included nationally recognized researchers in the topic area, expert clinicians (such as physicians,

nurses, pharmacists, and social workers), healthcare administrators, policy developers, economists,

government representatives, and consumers. The group designated the scope of the guideline and

conducted extensive reviews of the literature, including relevant systematic reviews, meta-analyses,

meta-syntheses, mixed-methods systematic reviews, individual studies, and theories.

The best research evidence available was synthesized to develop recommendations for prac-

tice. The guidelines were examined for their usefulness in clinical practice, impact on health

policy, and cost-effectiveness. Consultants, other researchers, and additional expert clinicians

often were asked to review the guidelines and provide input. Based on the experts’ critique,

the AHRQ revised and packaged the guidelines for distribution to healthcare professionals.

Some of the first guidelines focused on the following healthcare problems: (1) acute pain man-

agement in infants, children, and adolescents; (2) prediction and prevention of pressure ulcers

in adults; (3) urinary incontinence in adults; (4) management of functional impairments with

cataracts; (5) detection, diagnosis, and treatment of depression; (6) screening, diagnosis, man-

agement, and counseling about sickle cell disease; (7) management of cancer pain; (8) diagnosis

and treatment of heart failure; (9) low back problems; and (10) otitis media diagnosis and man-

agement in children.

National Guideline Clearinghouse Resources At the present time, standardized guideline development ranges from a structured process such as

the one just discussed to a less structured process in which a guideline might be developed by a

healthcare organization, healthcare plan, or professional organization. The AHRQ initiated the

National Guideline Clearinghouse (NGC; 2014b) in 1998 to store the evidence-based practice

guidelines. Initially, the NGC had 200 guidelines, but now the collection has expanded to thou-

sands of clinical practice guidelines. The NGC is a publicly available database of evidence-based

clinical practice guidelines and related documents. Free Internet access to these guidelines is

454 CHAPTER 13 Building an Evidence-Based Nursing Practice

available at http://www.guideline.gov. The NGC is updated weekly with new content that the

AHRQ produces in partnership with the American Medical Association and America’s Health

Insurance Plans. The key components of the NGC and its user-friendly resources can be found

on the AHRQ website (http://www.guideline.gov/index.aspx). Some of the critical information

on the NGC is provided here to show you what is available and how to access the NGC resources:

• Structured abstracts (summaries) about the guideline and its development

• Links to full-text guidelines, where available, and/or ordering information for print copies

• Downloads of the complete NGC summary for all guidelines represented in the database

• A guideline comparison utility that gives users the ability to generate side-by-side comparisons

for any combination of two or more guidelines

• Unique guideline comparisons, called Guideline Syntheses

These are prepared by NGC staff and compare guidelines covering similar topics, highlighting

areas of similarities and differences. NGC Guideline Syntheses often provide a comparison of

guidelines developed in different countries, providing insight into commonalities and differences

in international health practices.

• An electronic forum, NGC-L, for exchanging information on clinical practice guidelines, their

development, implementation, and use

• An annotated bibliography database in which users can search for citations for publications and

resources about guidelines, including guideline development and methodology, structure, eval-

uation, and implementation

Other features include the following (NGC, 2014a; http://www.guideline.gov/browse/by-topic.

aspx):

• What’s New enables users to see what guidelines have been added each week and includes an

index of all guidelines in NGC.

• NGC Update Service is a weekly electronic mailing of new and updated guidelines posted to the

NGC website.

• Detailed Search enables users to create very specific search queries based on the various attri-

butes found in the NGC Classification Scheme.

• NGC Browse permits users to scan for guidelines available on the NGC site by disease or con-

dition, treatment or intervention, or developing organization.

• Full-text guidelines and/or companion documents are available through the guideline devel-

oper and can be downloaded.

• The Glossary provides definitions of terms used in the standardized abstracts (summaries).

The NGC provides varied audiences with an easy to use mechanism for obtaining objective,

detailed information on clinical practice guidelines. The NGC (2014a) also provides a list of

the guidelines that are in the process of being developed. In addition to the evidence-based

guidelines, the AHRQ has developed many tools to assess the quality of care provided by the evi-

dence-based guidelines. You can search the AHRQ (2013) website (http://www.qualitymeasures.

ahrq.gov) for an appropriate tool to measure a variable in a research project or evaluate outcomes

of care in a clinical agency.

Numerous professional organizations, healthcare agencies, universities, and other groups pro-

vide evidence-based guidelines for practice, which can be found on the following websites:

• Academic Center for Evidence-Based Nursing—http://www.acestar.uthscsa.edu

• Association of Women’s Health, Obstetric, and Neonatal Nurse—http://awhonn.org

• Centers for Health Evidence—http://www.cche.net

• Guidelines Advisory Committee—http://www.gacguidelines.ca

• Guidelines International Network—http://www.g-i-n.net

455CHAPTER 13 Building an Evidence-Based Nursing Practice

• HerbMed, Evidence-Based Herbal Database, 1998, Alternative Medicine Foundation—http://

www.herbmed.org

• MD Consult—http://www.mdconsult.com/php/286943359-1063/homepage

• National Association of Neonatal Nurses—http://www.nann.org

• National Institute for Clinical Excellence (NICE)—http://www.nice.org.uk/catcg2.asp?c¼20034 • Oncology Nursing Society—http://www.ons.org

• U.S. Preventive Services Task Force—http://www.uspreventiveservicestaskforce.org/about.htm

Implementing Evidence-Based Guidelines for Management of Hypertension in Practice Evidence-based guidelines have become the standards for providing care to patients in the United

States and other countries. A few nurses have participated in committees that have developed these

evidence-based guidelines, and many nurses are using these guidelines in their practices. An

evidence-based guideline for the assessment, diagnosis, and management of high blood pressure

is provided as an example. This guideline was developed from the JNC 7 report that was published

in the Journal of the American Medical Association (Chobanian et al., 2003). The NIH, Department

of Health and Human Services, and National Heart, Lung, and Blood Institute (NHLBI) developed

educational materials to present the specifics of this guideline to promote its use by healthcare

providers. This guideline is presented in Figure 13-8; it provides clinicians with direction for

the following: (1) classification of blood pressure as normal, prehypertension, and HTN stages

1 and 2; (2) conduct of a diagnostic workup of HTN; (3) assessment of the major cardiovascular

disease risk factors; (4) assessment of the identification of causes of HTN; and (5) treatment of

HTN. The American Society of Hypertension and the International Society of Hypertension

guidelines include the same classification of HTN—prehypertension, stage 1 hypertension, and

stage 2 hypertension (Weber et al., 2014).

Algorithms or clinical decision trees provide direction for the selection of the most appropriate

treatment methods for each patient with an illness or disease. Figure 13-8 includes an algorithm for

managing patients diagnosed with HTN (NHLBI, 2003). In their international HTN guidelines,

Weber and colleagues (2014) provided a more detailed algorithm for the management of HTN

(Figure 13-9). This algorithm includes starting with lifestyle changes like the JNC 7 algorithm.

However, Weber and colleagues provide direction for management of HTN in both Black and

non-Black patients. Starting drug therapy for special cases (patients with kidney disease, diabetes,

coronarydisease, stroke history, and heart failure) are presented in the algorithm and detailed in the

discussion of the guidelines. This algorithm can assist nurses and physicians in implementing the

best treatment plans for patients of different cultures, ages, and chronic illnesses (see Figure 13-9).

RNs and students need to assess the usefulness and quality of each evidence-based guideline

before they implement it in their practice. Figure 13-10 presents the Grove Model for Implement-

ing Evidence-Based Guidelines in Practice. In this model, nurses identify a practice problem,

search for the best research evidence to manage the problem in their practice, and note that an

evidence-based guideline has been developed. The quality and usefulness of the guideline must

be assessed by the nurse before it is used in practice, which involves examining the following:

(1) authors of the guideline; (2) significance of the healthcare problem; (3) strength of the research

evidence; (4) link to national standards; and (5) cost-effectiveness of using the guideline in prac-

tice. The quality of the JNC 7 guideline is examined as an example using the four criteria identified

in the Grove model (see Figure 13-10). The authors of the JNC 7 guideline were expert researchers,

456 CHAPTER 13 Building an Evidence-Based Nursing Practice

clinicians (physicians), policy developers, healthcare administrators, and the National High Blood

Pressure Education Program Coordinating Committee. These authors have the expertise to

develop an evidence-based guideline for HTN.

“Hypertension is a significant healthcare problem because it affects approximately 50 million

individuals in the United States and approximately 1 billion individuals worldwide. . . . Hyper- tension is the most common primary diagnosis in the United States with 35 million office visits

as the primary diagnosis. . . . Recent clinical trials have demonstrated that effective BP [blood pressure] control can be achieved in most patients with hypertension, but the majority will

require 2 or more antihypertensive drugs.”

Chobanian et al., 2003, p. 2562

EVALUATION

Key: SBP = systolic blood pressure DBP = diastolic blood pressure

Classification of blood pressure (BP)*

Diagnostic workup of hypertension

Assess for major cardiovascular disease (CVD) risk factors

• Assess risk factors and comorbidities. • Reveal identifiable causes of hypertension. • Assess presence of target organ damage. • Conduct history and physical examination. • Obtain laboratory tests: urinalysis, blood glucose, hematocrit. and lipid panel, serum potassium, creatinine, and calcium. Optional: urinary albumin/creatinine ratio. • Obtain electrocardiogram.

• Hypertension • Obesity (body mass index ≥30 kg/m2) • Dyslipidemia • Diabetes mellitus • Cigarette smoking

• Physical inactivity • Microalbuminuria, estimated glomerular filtration rate <60 mL/min • Age (>55 for men, >65 for women) • Family history of premature CVD (men age <55, women age <65)

Assess for identifiable causes of hypertension

• Sleep apnea • Drug induced/related • Chronic kidney disease • Primary aldosteronism • Renovascular disease

• Cushing’s syndrome or steroid therapy • Pheochromocytoma • Coarctation of aorta • Thyroid/parathyroid disease

SBP mm HgCategory DBP mm Hg

Normal Prehypertension Hypertension, Stage 1 Hypertension, Stage 2

<120 120–139 140–159 ≥160

and or or or

<80 80–89 90–99 ≥100

Lifestyle modifications

Initial drug choices

Not at goal blood pressure

Optimize dosages or add additional drugs until goal blood pressure is achieved. Consider consultation with

hypertension specialist.

Without compelling indications

With compelling indications

Stage 1 hypertension

(SBP 140–159 or DBP 90–99 mm Hg)

Thiazide-type diuretics for most. May consider ACEI, ARB, BB,CCB,

or combination.

Stage 2 hypertension (SBP ≥160 or

DBP ≥100 mm Hg) 2-drug combination

for most (usually thiazide-type diuretic and ACEI, or ARB,

or BB, or CCB).

Drug(s) for the compelling indications

Other antihypertensive

drugs (diuretics, ACEI, ARB, BB, CCB)

as needed.

TREATMENT

Principles of hypertension treatment • Treat to BP <140/90 mm Hg or BP <130/80 mm Hg in patients with diabetes or chronic kidney disease. • Majority of patients will require two medications to reach goal.

Algorithm for treatment of hypertension

See Compelling Indications for

Individual Drug Classes

See Strategies for Improving Adherence to Therapy

Not at goal blood pressure (<140/90 mm Hg) (<130/80 mm Hg for patients with diabetes

or chronic kidney disease) See Strategies for Improving Adherence to Therapy

*See Blood Pressure Measurement Techniques (reverse side)

FIG 13-8 Reference card from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC 7]. (From U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute. (2003). Reference card from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, MD: NIH Publication No. 03-5231. Retrieved August 3, 2009, from www.nhlbi.nih.gov/guidelines/ hypertension/jnc7card.htm.)

457CHAPTER 13 Building an Evidence-Based Nursing Practice

Blood pressure �140/90 in adults aged �18 years (For age � 80 years, pressure �150/90 or � 140/90 if high risk [diabetes, kidney disease])

Start lifestyle changes (Lose weight, reduce dietary salt and alchohol, stop smoking)

Drug therapy (Consider a delay in uncomplicated Stage 1 patients)*

Start drug therapy (In all patients)*

Stage 1 140-159/90-99

Black patients Non-black patients

Age �60 years

Age �60 years

CCB or Thiazide CCB or Thiazide

CCB + Thiazide + ACE-i (or ARB) CCB + Thiazide + ACE-i (or ARB)

CCB or Thiazide +

ACE-i or ARB

CCB or Thiazide

ACE-i or ARB

ACE-i or ARB ACE-i or ARB

or combine CCB + Thiazide

If needed, add...

If needed... If needed... If needed... If needed...

If needed, add... If needed, add...

If needed, add other drugs, e.g. spironolactone; centrally acting agents; �-blockers

If needed, refer to a hypertension specialist

Start with two drugs

All patients

Stage 2 �160/100

Special cases

� Kidney disease � Diabetes � Coronary disease � Stroke history � Heart failure [see table of recommended drugs for these conditions]

In Stage 1 patients without other cardio- vascular risk factors or abnormal findings, some months of regularly monitored lifestyle management without drugs can be considered.

*

FIG 13-9 This algorithm summarizes the main recommendations of these guidelines. (From Weber, M. A., Schiffrin, E. L., White, W. B., Mann, S., Lindholm, L. H., Kenerson, J. G., et al. (2014). Clinical practice guidelines for the management of hypertension in the community: A statement by the American Society of Hypertension and the International Society of Hypertension. Journal of Clinical Hypertension, 32(1), 20). ACE-i, Angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blocker; CCB, calcium channel blocker; Thiazide, thiazide or thiazide-like diuretics.

4 5 8

C H A P T E R 1 3

B u ild

in g a n E v id e n c e -B a s e d N u rs in g P ra c tic

e

The research evidence for the development of the JNC 7 guideline was extremely strong. The

JNC 7 report included 81 references; 9 (11%) of the references were meta-analyses and 35 (43%)

were RCTs; 44 (54%) sources are considered extremely strong research evidence. The other refer-

ences were strong and included retrospective analyses or case-controlled studies, prospective or

cohort studies, cross-sectional surveys or prevalence studies, and clinical intervention studies

(Nonrandom; Chobanian et al., 2003). The JNC 7 provides the national standard for the assess-

ment, diagnosis, and treatment of HTN. The recommendations from the JNC 7 are supported by

the U.S. Department of Health and Human Services and disseminated through NIH publication

No. 03-5231. Use of the JNC 7 guideline in practice is cost-effective because the clinical trials have

shown that “antihypertensive therapy has been associated with 35% to 40% mean reductions in

stroke incidence; 20% to 25% in myocardial infarction [MI]; and more than 50% in HF [heart

failure]” (Chobanian et al., 2003, p. 2562).

Cost effectiveness

analysis

Practice problem

Search for best evidence yields evidence-based guideline

Integration of evidence-based guideline with clinical expertise

Refinement of evidence-based guideline

Evidence-based practice

Quality of evidence-based guideline

Authors of guidelines Significance of healthcare problem

Strength of research evidence

Link to national standards

Use of evidence-based guideline in practice Patient, provider, healthcare agency

Monitor outcomes from use of evidence-based guideline Patient, provider, healthcare agency

FIG 13-10 Grove Model for Implementing Evidence-Based Guidelines in Practice.

459CHAPTER 13 Building an Evidence-Based Nursing Practice

The next step is for nurses and physicians to use the JNC 7 guideline in their practice to clas-

sify patients’ blood pressures and assess their major cardiovascular disease (CVD) risk factors

(see Figure 13-8). Nurses and students can use this information to educate patients about their

blood pressure and encourage them to make lifestyle changes (e.g., weight loss, no added salt in

their diet, exercise program, smoking cessation) to decrease their CVD risks. Nurses also need to

examine the outcomes for the patient, nurse, physician, and healthcare agency. The outcomes

would be recorded in the patients’ charts and possibly in a database (because of the implemen-

tation of EHRs) and would include the following: (1) blood pressure readings for patients; (2)

incidence of diagnosis of HTN based on the JNC 7 or international HTN guidelines (Weber

et al., 2014); (3) appropriateness of the treatments implemented to manage HTN based on

JNC7 or international HTN guidelines; and (4) incidence of stroke, MI, and HF over 5, 10,

15, and 20 years. The healthcare agency outcomes include the access to care by patients with

HTN, patient satisfaction with care, and the cost related to diagnosis and treatment of

HTN and the complications of stroke, MI, and HF. EBP guidelines are refined in the future

based on clinical outcomes, outcome studies, and new RCTs and meta-analyses. The JNC 7

guidelines are currently under revision but the guidelines proposed by James and colleagues

(2014) have not been approved by government or professional organizations. Currently the

JNC 7 and the international HTN guidelines published by Weber and colleagues (2014) provide

the most relevant evidence-based guidelines for the management of HTN in adults. The use

of these evidence-based HTN guidelines and additional guidelines promote an EBP for nurses

(see Figure 13-10).

INTRODUCTION TO EVIDENCE-BASED PRACTICE CENTERS

In 1997, the AHRQ launched its initiative to promote EBP by establishing 12 evidence-based prac-

tice centers (EPCs) in the United States and Canada.

“The EPCs develop evidence reports and technology assessments on topics relevant to clinical,

social science/behavioral, economic, and other healthcare organization and delivery issues—

specifically those that are common, expensive, and/or significant for the Medicare and Medicaid

populations. With this program, AHRQ became a ‘science partner’ with private and public orga-

nizations in their efforts to improve the quality, effectiveness, and appropriateness of health care

by synthesizing the evidence and facilitating the translation of evidence-based research findings.

Topics are nominated by non-federal partners such as professional societies, health plans,

insurers, employers, and patient groups.”

AHRQ, 2012; http://www.ahrq.gov/clinic/epc

Under the EPC program, the AHRQ awards 5-year contracts to institutions to serve as EPCs.

EPCs review all relevant scientific literature on clinical, behavioral, organizational, and financial

topics to produce evidence reports and technology assessments. These reports are used to inform

and develop coverage decisions, quality measures, educational materials, tools, guidelines, and

research agendas. The EPCs also conduct research on the methodology of systematic reviews.

The AHRQ (2012) website (http://www.ahrq.gov/clinic/epc) provides the names of the

EPCs and the focus of each center. This site also provides a link to the evidence-based reports

produced by these centers. These EPCs have had an important role in the development of

evidence-based guidelines since the 1990s and will continue to make significant contributions

to EBP in the future.

460 CHAPTER 13 Building an Evidence-Based Nursing Practice

INTRODUCTION TO TRANSLATIONAL RESEARCH

Some barriers to EBP have resulted in the development of a new type of research to improve the

translation of research knowledge to practice. This new research methodology, termed transitional

research, is being supported by the NIH (2012). Translational research is an evolving concept

defined by the NIH as the translation of basic scientific discoveries into practical applications. Basic

research discoveries from the laboratory setting need to be tested in human studies. Also, the out-

comes from human clinical trials need to be adopted and maintained in clinical practice. Trans-

lational research is being encouraged by medicine and nursing to increase the implementation of

evidence-based interventions in practice and determine if these interventions are effective in pro-

ducing the outcomes desired in clinical practice (Chesla, 2008; NIH, 2012). Translational research

was originally part of the National Center for Research Resources. However, in December 2011, the

National Center for Advancing Translation Sciences (NCATS) was developed as part of the NIH

institutes and centers (NIH, 2012).

The NIH wanted to encourage researchers to conduct translational research and developed the

Clinical and Translational Science Awards (CTSA) consortium in October 2006. The consortium

started with 12 centers located throughout the United States and expanded to 39 centers in April

2009. The program was fully implemented in 2012, with about 60 institutions involved in clinical

and translational science.

The CTSA consortium is mainly focused on expanding the translation of medical research to

practice. Titler (2004, p. S1) defined transitional research for the nursing profession as the

“Scientific investigation of methods, interventions, and variables that influence adoption of

evidence-based practices (EBPs) by individuals and organizations to improve clinical and opera-

tional decision making in health care. This includes testing the effect of interventions on promot-

ing and sustaining the adoption of EBPs.” Baumbusch and colleagues (2008) provided an agenda

for translational research and developed a collaborative model for knowledge translation between

research and practice in clinical settings. Callard, Rose, and Wykes (2012) identified four different

phases of translational research and stressed the importance of including service users in these

types of studies. As you search the literature for relevant research syntheses and studies, you will

note that translation studies are being published in nursing. Whittemore and colleagues (2009)

conducted a translation study to promote the transfer of a diabetic prevention program to primary

care. These types of studies will assist you in translating research findings to your practice and

determining the impact of EBP on patients’ health. However, federal funding is needed to expand

the conduct of transitional research in nursing.

We hope that the content in this chapter increases your understanding of EBP, critical appraisal

of research syntheses, application of EBP models, and implementation of EBP guidelines. We

encourage you to take an active role in moving nursing toward EBP that improves outcomes

for patients, nurses, and healthcare agencies.

K E Y C O N C E P T S

• Evidence-based practice (EBP) is the conscientious integration of best research evidence with

clinical expertise and patient values and needs in the delivery of quality, safe, cost-effective

health care.

• Best research evidence is produced by the conduct and synthesis of numerous high-quality stud-

ies in a health-related area.

461CHAPTER 13 Building an Evidence-Based Nursing Practice

• There are benefits and barriers associated with EBP. The benefits of EBP are that the standards

for hospital accreditation by The Joint Commission support EBP, as does the Magnet Hospital

Program managed by the American Nurses’ Credentialing Center.

• The Quality and Safety Education for Nurses (QSEN) Institute has identified competencies for

prelicensure nurses to promote the use of evidence-based knowledge in practice.

• Guidelines are provided for critically appraising the research synthesis processes of systematic

review, meta-analysis, meta-synthesis, and mixed-methods systematic review. These synthesis

processes are used to determine the best research evidence in a selected area and quality of the

research evidence available for practice.

• A systematic review is a structured, comprehensive synthesis of the research literature to deter-

mine the best research evidence available to address a healthcare question. A systematic review

involves identifying, locating, appraising, and synthesizing quality research evidence for expert

clinicians to use to promote EBP.

• A meta-analysis is conducted to pool the results from previous studies statistically into a single

quantitative analysis that provides one of the highest levels of evidence about the effectiveness of

an intervention.

• Meta-synthesis is defined as the systematic compilation and integration of qualitative study

results to expand understanding and develop a unique interpretation of study findings in a

selected area. The focus is on interpretation rather than on combining study results, as with

quantitative research synthesis.

• Reviews that include syntheses of various quantitative, qualitative, and mixed-methods studies

are referred to as mixed-methods systematic reviews in this text.

• The PICO format is described for generating a clinical question to guide the use of current

research evidence in practice. Evidence-based guidelines are provided for administering IM

injections to children, adolescents, and adults.

• Two models have been developed to promote EBP in nursing, the Stetler Model of Research

Utilization to Facilitate EBP (Stetler, 2001) and the Iowa Model of EBP to Promote Quality

of Care (Titler et al., 2001).

• The phases of the revised Stetler model are (I) preparation, (II) validation, (III) comparative

evaluation/decision making, (IV) translation/application, and (V) evaluation.

• The Iowa model provides guidelines for implementing patient care based on the best research

evidence and monitoring changes in practice to ensure quality care.

• The process for developing evidence-based guidelines is described, and an example of the guide-

line for assessment, diagnosis, and treatment of hypertension is provided.

• The Grove Model for Implementing Evidence-Based Guidelines in Practice is provided to assist

nurses in determining the quality of evidence-based guidelines and the steps for using these

guidelines in practice.

• An excellent source for evidence-based guidelines is the National Guideline Clearinghouse, ini-

tiated by the AHRQ in 1998.

• Evidence-based practice centers (EPCs), created by the AHRQ in 1997, have had an important

role in the conduct of research, development of systematic reviews, and formulation of

evidence-based guidelines in selected practice areas.

• Translational research is an evolving concept defined by the NIH as the translation of basic sci-

entific discoveries into practical applications.

462 CHAPTER 13 Building an Evidence-Based Nursing Practice

REFERENCES

Agency for Healthcare Research and Quality (AHRQ).

(2012). Evidence-based practice centers: Synthesizing

scientific evidence to improve quality and effectiveness in

health care. Retrieved July 15, 2013, from, http://www.

ahrq.gov/clinic/epc.

Agency for Healthcare Research and Quality (AHRQ).

(2013). National Quality Measures Clearinghouse

(NQMC). Retrieved July 15, 2013, from, http://

qualitymeasures.ahrq.gov.

American Nurses Credentialing Center. (2014). Find a

magnet organization. Silver Springs, MD: Author.

Retrieved February 11, 2014, from, http://www.

nursecredentialing.org/Magnet/FindaMagnetFacility.

aspx.

Andrel, J. A., Keith, S. W., & Leiby, B. E. (2009).

Meta-analysis: A brief introduction. Clinical and

Translational Science, 2(5), 374–378.

Barnett-Page, E., & Thomas, J. (2009). Methods for the

synthesis of qualitative research: A critical review. BMC

Medical Research Methodology, 9(59). http://dx.doi.

org/10.1186/147-2288-9-59.

Baumbusch,J.L.,Kirkham,S.R.,Khan,K.B.,McDonald,H.,

Semeniuk, P., Tan, E., et al. (2008). Pursuing common

agendas:Acollaborativemodelforknowledgetranslation

between research and practice in clinical settings.

Research in Nursing & Health, 31(2), 130–140.

Benzies, K. M., Premji, S., Hayden, K. A., & Serrett, K.

(2006). State-of-the-evidence reviews: Advantages and

challenges of including grey literature. Worldviews on

Evidence-Based Nursing, 3(2), 55–61.

Bettany-Saltikov, J. (2010a). Learning how to undertake a

systematic review: Part 1. Nursing Standard, 24(50),

47–56.

Bettany-Saltikov, J. (2010b). Learning how to undertake a

systematic review: Part 2. Nursing Standard, 24(51),

47–58.

Bolton, L. B., Donaldson, N. E., Rutledge, D. N.,

Bennett, C., & Brown, D. S. (2007). The impact of

nursing interventions: Overview of effective

interventions, outcomes, measures, and priorities for

future research. Medical Care Research and Review,

64(Suppl. 2), 123S–143S.

Brown, S. J. (2014). Evidence-based nursing: The research-

practice connection (3rd ed.). Sudbury, MA: Jones &

Bartlett.

Butler, K. D. (2011). Nurse practitioners and evidence-

based nursing practice. Clinical Scholars Review, 4(1),

53–57.

Callard, F., Rose, D., & Wykes, T. (2012). Close to the

bench as well as the bedside: Involving service users in

all phases of translational research. Health Expectations,

15(4), 389–400.

Chesla, C. A. (2008). Translational research: Essential

contributions from interpretive nursing science.

Research in Nursing & Health, 31(4), 381–390.

Chobanian,A.V.,Bakris,G.L.,Black,H.R.,Cushman,W.C.,

Green, L. A., Izzo, J. L., et al. (2003). The Seventh Report

of the Joint National Committee on Prevention,

Detection, Evaluation, and Treatment of High Blood

Pressure: The JNC 7 Report. Journal of the American

Medical Association, 289(19), 2560–2572.

Choi, M., & Hector, M. (2012). Effectiveness of

intervention programs in preventing falls: A systematic

review of recent 10 years and meta-analysis. Journal of

the American Medical Directors Association, 13(2),

188.e13–188.e21. http://dx.doi.org/10.1016/j.

jamda.2011.04.022.

Cochrane Collaboration. (2014). Cochrane reviews.

Retrieved February 11, 2014, from, http://www.

cochrane.org/cochrane-reviews.

Cocoman, A., & Murray, J. (2008). Intramuscular

injections: A review of best practice for mental health

nurses. Journal of Psychiatric and Mental Health

Nursing, 15(5), 424–434.

Conn, V. S. (2010). Depressive symptom outcomes of

physical activity interventions: Meta-analysis findings.

Annals of Behavioral Medicine, 39(2), 128–138.

Conn, V. S., & Rantz, M. J. (2003). Research

methods: Managing primary study quality in

meta-analyses. Research in Nursing & Health, 26(4),

322–333.

Conn, V. S., Valentine, J. C., Cooper, H. M., & Rantz, M. J.

(2003). Methods: Grey literature in meta-analyses.

Nursing Research, 52(4), 256–261.

Craig, J., & Smyth, R. (2012). The evidence-based practice

manual for nurses (3rd ed.). Edinburgh, Scotland:

Churchill Livingstone Elsevier.

Creswell, J. W. (2014). Research design: Qualitative,

quantitative and mixed methods approaches (4th ed.).

Thousand Oaks, CA: Sage.

Denieffe, S., & Gooney, M. (2011). A meta-synthesis

of women’s symptoms experience and breast

cancer. European Journal of Cancer Care, 20(4),

424–435.

Doran, D. M. (2011). Nursing sensitive outcomes: The state

of the science (2nd ed.). Sudbury, MA: Jones & Bartlett.

463CHAPTER 13 Building an Evidence-Based Nursing Practice

Eizenberg,M.M.(2010).Implementationofevidence-based

nursing practice: Nurses’ personal and professional

factors? Journal of Advanced Nursing, 67(1), 33–42.

Fawcett, J., & Garity, J. (2009). Evaluating research for

evidence-based nursing practice. Philadelphia:

F. A. Davis.

Fernandez, R. S., & Tran, D. T. (2009). The meta-analysis

graph: Clearing the haze. Clinical Nurse Specialist CNS,

23(2), 57–60.

Finfgeld-Connett, D. (2010). Generalizability and

transferability of meta-synthesis research findings.

Journal of Advanced Nursing, 66(2), 246–254.

Greenway, K. (2004). Using the ventrologluteal site for

intramuscular injection. Nursing Standard, 18(25),

39–42.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation of

evidence (7th ed.). Philadelphia: Elsevier Saunders.

Harden, A., & Thomas, J. (2005). Methodological

issues in combining diverse study types in systematic

reviews. International Journal of Social Research

Methodology, 8(3), 257–271.

Higgins, J. P., & Green, S. (2008). Cochrane handbook for

systematic reviews of interventions: Cochrane book series.

West Sussex, UK: The Cochrane Collaboration and

John Wiley & Sons.

Hoare, Z., & Hoe, J. (2013). Understanding quantitative

research: Part 2. Nursing Standard, 27(18), 48–55.

Hoe, J., & Hoare, Z. (2012). Understanding quantitative

research: Part 1. Nursing Standards, 27(15–17), 52–57.

Horstman, P., & Fanning, M. (2010). Tips for writing

magnet evidence. Journal of Nursing Administration,

40(1), 4–6.

Institute of Medicine. (2001). Crossing the quality chasm: A

new health system for the 21st century. Washington, DC:

National Academy Press.

James, P. A., Opari, S., Carter, B. L., Cushman, W. C.,

Dennison-Himmelfarb, C., Handler, J., et al. (2014).

2014 Evidence-based guideline for the management of

high blood pressure in adults: Report from the panel

members appointed to the Eighth Joint National

Committee (JNC 8). JAMA, 311(5), 507–520.

Joanna Briggs Institute. (2014). Welcome to the Joanna

Briggs Institute: Home. Retrieved February 11, 2014,

from, http://www.joannabriggs.org/index.html.

Kent, B., & Fineout-Overholt, E. (2008). Using

meta-synthesis to facilitate evidence-based practice.

Worldviews on Evidence-Based Nursing, 5(3), 160–162.

Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C.,

Gotzsche, P. C., Ioannidis, J. P., et al. (2009).

The PRISMA Statement for reporting systematic

reviews and meta-analyses of studies that evaluate

healthcare interventions: Explanation and elaboration.

Annals of Internal Medicine, 151(4), W-65–W-94.

Magnus, M. C., Ping, M., Shen, M. M., Bourgeois, J., &

Magnus, J. H. (2011). Effectiveness of mammography

screening in reducing breast cancer mortality in

women aged 39-49 years: A meta-analysis. Journal of

Women’s Health, 20(6), 845–852.

Mantzoukas, S. (2009). The research evidence published in

high impact nursing journals between 2000 and 2006:

A quantitative content analysis. International Journal of

Nursing Studies, 46(4), 479–489.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-

based practice in nursing & healthcare: A guide to best

practice (2nd ed.). Philadelphia: Lippincott, Williams,

& Wilkins.

Melnyk, B. M., Fineout-Overholt, E., Stillwell, S. B., &

Williamson, K. M. (2010). The seven steps of evidence-

based practice. American Journal of Nursing, 110(1),

51–53.

Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., &

PRISMA Group. (2009). Preferred Reporting Items for

Systematic Reviews and Meta-Analyses: The PRISMA

Statement. Retrieved July 9, 2013 from, http://www.

prisma-statement.org.

Moore, Z. (2012). Meta-analysis in context. Journal of

Clinical Nursing, 21(19/20), 2798–2807.

National Guideline Clearinghouse (NGC). (2014a).

National Guideline Clearinghouse: Guidelines by topics.

Retrieved February 11, 2014, from, http://www.

guideline.gov/browse/by-topic.aspx.

National Guideline Clearinghouse (NGC). (2014b).

National Guideline Clearinghouse: Home. Retrieved

February 11, 2014, from, http://www.guideline.gov/.

National Heart, Lung, and Blood Institute. (2003). The

Seventh Report of the Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of

High Blood Pressure (JNC 7). Bethesda, MD: National

Institutes of Health. Retrieved July 9, 2013 from,

www.nhlbi.nih.gov/guidelines/hypertension.

National Institutes of Health (NIH). (2012). NIH:

National Center for Translational Science. Retrieved

July 9, 2013 from, http://www.ncrr.nih.gov/clinical_

research_resources/clinical_and_translational_

science_awards/index.asp.

Nicoll, L. H., & Hesby, A. (2002). Intramuscular injection:

An integrative research review and guideline for

evidence-based practice. Applied Nursing Research,

16(2), 149–162.

464 CHAPTER 13 Building an Evidence-Based Nursing Practice

Nurse Executive Center. (2005). Evidence-based nursing

practice: Instilling rigor into clinical practice.

Washington, DC: Advisory Board Company.

Quality and Safety Education for Nurses (QSEN). (2013).

Pre-licensure knowledge, skills, and attitudes (KSAs).

Retrieved February 11, 2014, from, http://qsen.org/

competencies/pre-licensure-ksas.

Rew, L. (2011). The systematic review of literature:

Synthesizing evidence for practice. Journal for

Specialists in Pediatric Nursing, 16(1), 64–69.

Sackett, D. L., Straus, S. E., Richardson, W. S.,

Rosenberg, W., & Haynes, R. B. (2000). Evidence-based

medicine: How to practice & teach EBM (2nd ed.).

London: Churchill Livingstone.

Sandelowski, M., & Barroso, J. (2007). Handbook

for synthesizing qualitative research. New York:

Springer.

Schumacher, B., Askew, M., & Otten, K. (2013).

Development of a pressure ulcer trigger tool for the

neonatal population. Journal of Wound, Ostomy, and

Continence Nursing, 40(1), 46–50.

Sherwood, G., & Barnsteiner, J. (2012). Quality and safety

in nursing: A competency approach to improving

outcomes. Ames, IA: Wiley-Blackwell.

Stetler, C. B. (2001). Updating the Stetler Model of

Research Utilization to facilitate evidence-based

practice. Nursing Outlook, 49(6), 272–279.

Stetler, C. B., & Marram, G. (1976). Evaluating research

findings for applicability in practice. Nursing Outlook,

24(9), 559–563.

Straka, K. L., Brandt, P., & Brytus, J. (2013). Brief report:

Creating a culture of evidence-based practice and

nursing research in a pediatric hospital. Journal of

Pediatric Nursing, 28(4), 374–378.

The Joint Commission. (2014). About our standards.

Retrieved February 11, 2014, from, http://www.

jointcommission.org/standards_information/

standards.aspx.

Titler, M. G. (2004). Overview of the U.S. invitational

conference “Advancing Quality Care Through

Translation Research.” Worldviews on Evidence-Based

Nursing, 1(1), S1–S5.

Titler, M. G., Kleiber, C., Steelman, V. J., Rakel, B. A.,

Budreau, G., Everett, L. Q., et al. (1994). Research-

based practice to promote the quality of care. Nursing

Research, 43(5), 307–313.

Titler, M. G., Kleiber, C., Steelman, V. J., Rakel, B. A.,

Budreau, G., Everett, L. Q., et al. (2001). The Iowa

Model of Evidence-Based Practice to promote

quality care. Critical Care Nursing Clinics of North

America, 13(4), 497–509.

Turlik, M. (2010). Evaluating the results of a systematic

review/meta-analysis. Podiatry Management, Retrieved

from, www.podiatrym.com.

Walsh, D., & Downe, S. (2005). Meta-synthesis method for

qualitative research: A literature review. Journal of

Advanced Nursing, 50(2), 204–211.

Weber, M. A., Schiffrin, E. L., White, W. B., Mann, S.,

Lindholm, L. H., Kenerson, J. G., et al. (2014).

Clinical practice guidelines for the management

of hypertension in the community: A statement

by the American Society of Hypertension and the

International Society of Hypertension. Journal of

Clinical Hypertension, 16(1), 14–26.

Whittemore, R., Melkus, G., Wagner, J., Dziura, J.,

Northrup, V., & Grey, M. (2009). Translating the

diabetes prevention program to primary care: A pilot

study. Nursing Research, 58(1), 2–12.

Wulff, K., Cummings, G. G., Marck, P., & Yurtseven, O.

(2011). Medication administration technologies and

patient safety: A mixed-method systematic review.

Journal of Advanced Nursing, 67(10), 2080–2085.

465CHAPTER 13 Building an Evidence-Based Nursing Practice

C H A P T E R

14 Outcomes Research

Diane Doran, RN, PhD, FCAHS

C H A P T E R OV E R V I E W

Theoretical Basis of Outcomes Research, 468

Nursing-Sensitive Outcomes, 469

Origins of Outcomes and Performance

Monitoring, 472

Federal Government Involvement in Outcomes

Research, 473

Agency for Healthcare Research and Quality

(AHRQ), 473

American Recovery and Reinvestment Act, 473

National Quality Forum, 474

National Database of Nursing Quality

Indicators, 474

Oncology Nursing Society, 476

Advanced Practice Nursing Outcomes

Research, 476

Outcomes Research and Nursing Practice, 477

Evaluating Outcomes of Care, 477

Evaluating Structure of Care, 478

Evaluating Process of Care, 480

Methodologies for Outcomes Studies, 481

Samples and Sampling, 481

Study Designs, 483

Measurement Methods, 488

Statistical Methods for Outcomes Studies, 491

Analysis of Change, 491

Analysis of Improvement, 491

Critical Appraisal of Outcomes

Studies, 492

Questions Guiding the Critical Appraisal of

Outcomes Studies, 492

Example Critical Appraisal of an Outcomes

Study, 493

Key Concepts, 494

References, 495

L E A R N I N G O U T C O M E S

After completing this chapter, you should be able to: 1. Explain the theoretical basis of outcomes

research.

2. Discuss the history of outcomes research in

nursing.

3. Describe the role of outcomes research in

determining the effect of nursing on health

outcomes.

4. Differentiate outcomes research from other types

of research conducted by nurses.

5. Identify the methodologies used in published

outcomes studies.

6. Critically appraise published outcomes studies.

466

K E Y T E R M S

Administrative databases, p. 483

Clinical databases, p. 483

Distal outcome, p. 478

Nurse’s role in outcomes, p. 470

Nursing Care Report Card,

p. 474

Nursing-sensitive patient

outcome, p. 471

Outcomes research, p. 467

Patient health outcomes, p. 473

Population-based studies, p. 487

Prospective cohort study, p. 484

Proximal outcome, p. 478

Quality of care, p. 468

Retrospective cohort study,

p. 485

Secondary analysis, p. 488

Standard of care, p. 480

Standardized mortality ratio

(SMR), p. 486

Structural variables, p. 478

Structure in outcomes, p. 470

Structures of care, p. 478

Outcomes research, now an established field of health research, focuses on the end results of

patient care. More specifically, outcomes research is concerned with the effectiveness of healthcare

interventions and health services (Doran, 2011; Jefford, Stockler, & Tattersall, 2003). In the context

of nursing, it focuses on how a patient’s health status changes as a result of the nursing care received

or the nursing services delivered. The Agency for Healthcare Research and Quality (AHRQ) sug-

gests that “outcomes research seeks to understand the end results of particular healthcare practices

and interventions. End results include effects that people experience and care about, such as change

in the ability to function. In particular, for individuals with chronic conditions, where cure is not

always possible, end results include quality of life as well as mortality. By linking the care people

receive to the outcomes they experience, outcomes research has become the key to developing

better ways to monitor and improve quality of care” (AHRQ, 2013).

The momentum propelling outcomes research comes primarily from policy makers, insurers,

and the public. In these times of economic efficiency in the public health sector, there is a grow-

ing demand for data that justify the interventions and the costs of care and for systems of care

that demonstrate improved patient outcomes. In that regard, nursing-sensitive outcomes have

become an issue of increasing interest because of national concerns related to the quality of

patient care. The interest in research on outcomes is clearly relevant to the nursing profession.

Because nurses are at the forefront of care delivery, the demand for professional accountability

regarding patient outcomes dictates that we can identify and document outcomes influenced

by our care.

This chapter addresses the theoretical basis of outcomes research, provides a brief history of the

emerging endeavors to examine outcomes, explains the importance of outcomes research designed

to examine nursing practice, and highlights methodologies used in outcomes research. The chapter

concludes with an introduction to guidelines that might be used to critically appraise outcomes

studies. The movement to outcomes research and the approaches described in this chapter are a

worldwide phenomenon.

Outcomes research differs significantly from the other types of research addressed in this text. It

is a more complex study. Its designs are different, and the researchers engaged in it are often from a

mix of disciplines, such as economics and public health, as well as from nursing. The studies use a

unique theoretical framework to focus on health outcomes. In keeping with the interprofessional

perspective of outcomes research, a broad base of literature from a variety of disciplines was used to

develop the content for this chapter.

467CHAPTER 14 Outcomes Research

THEORETICAL BASIS OF OUTCOMES RESEARCH

The theorist Avedis Donabedian (1976, 1978, 1980, 1982, 1987) proposed a theory of quality health

care and provided a process for evaluating it. Donabedian’s theory still dominates outcomes

research. Other theories of outcomes have since been developed, but we will limit our discussion

to Donabedian’s theory. Although quality is the overriding construct of Donabedian’s theory, he

never actually defined this concept himself (Mark, 1995). The World Health Organization (WHO;

2009, p. 13) defined quality of care as the “degree to which health services for individuals and

populations increase the likelihood of desired health outcomes and are consistent with current

professional knowledge.”

Donabedian (1987) represented the key concepts and relationships in his theory using a cube.

The cube shown in Figure 14-1 helps explain the elements of quality health care. The three dimen-

sions of the cube are health, the subjects of care, and the providers of care. The cube also incor-

porates three of the many aspects of health—physical-psychological function, psychological

function, and social function. Donabedian (1987, p. 4) proposed that “the manner in which we

conceive of health, and of our responsibility for it, makes a fundamental difference to the concept

of quality and, as a result, to the methods that we use to assess and assure the quality of care.”

Loegering, Reiter, and Gambone (1994) modified Donabedian’s levels to include the patient,

patient’s family, and community as providers as well as recipients of care. They suggest that access

to care is one dimension of the provision of care by the community. Figure 14-2 illustrates their

modifications.

Plan, institution, system

Organized team

Several practitioners*

Individual practitioner

Physical-psychological function

Psychological function

Social function

Patient

*Of the same profession or of different professions

Person

In d iv

id u a l

A g g re

g a te

: ca

se lo

a d

In d iv

id u a l

A g g re

g a te

: ta

rg e t

p o p u la

tio n ,

co m

m u n ity

FIG 14-1 Level and scope of concern as factors in the definition of quality. (From Donabedian, A. (1987). Some basic issues in evaluating the quality of health care. In L. T. Rinke (Ed.), Outcome measures in home care: Vol. 1 (pp. 3–28). New York: National League of Nursing.)

468 CHAPTER 14 Outcomes Research

Donabedian (1987, 2005) identified three foci of evaluation in appraising quality—structure (e.g.,

nursing units, hospitals, home health agencies), process (of how care is provided, such as a practice

style or standard of care), and outcomes (end results of care). Each of these constructs is addressed in

this chapter. A complete quality assessment program requires the simultaneous inclusion of all three

and an examination of the relationships among them. However, researchers have had little success in

accomplishing this theoretical goal. Studies designed to examine all three constructs would require

sufficiently large samples of various structures, each with the various processes being compared and

large samples of subjects who have experienced the outcomes of those processes. The funding

required and cooperation necessary to accomplish this goal have not yet been realized; however, there

are examples of nursing research in which two or more aspects have been evaluated. Numerous

studies conducted by nurses in the United States (Aiken, Clarke, Sloane, Lake, & Cheney, 2008;

Kutney-Lee, Sloane, & Aiken, 2013; Stone, Mooney-Kane, Larson, Horan, Glance, Zwanziger,

et al., 2007; Yoder, Xin, Norris, & Yan, 2013), Canada (Doran et al., 2006a, 2006b; Doran, Sidani,

Keatings, & Doidge, 2002; McGillis Hall et al., 2003; Tourangeau, 2003; Tourangeau et al., 2007),

and internationally (Bakker et al., 2011; Oh, Park, Jin, Piao, & Lee, 2013; Van den Heede, et al.,

2009) have explored the relationships among nursing interventions, nursing services, and patient

outcomes. Nursing interventions reflect the care delivered by nurses. A falls risk assessment or pres-

sure ulcer risk assessment are examples of nursing interventions. Nursing services is a general concept

referring to the organization and administration of nursing activities. Nursing service variables that

have been studied include the skill mix and configuration of nursing personnel; staffing levels; assign-

ment patterns (primary, functional, or team); shift patterns; levels of nursing education, experience,

and expertise; ratios of full-time to part-time nurses; level and type of nursing leadership available

centrally and on units; cohesion and communication among the nursing staff and between nurses

and physicians; implementation of clinical care maps for patients with selected diagnoses; and the

interrelationships of these factors.

NURSING-SENSITIVE OUTCOMES

Irvine, Sidani, and McGillis Hall (1998) adapted Donabedian’s (1987) theory of quality in their

development of the Nursing Role Effectiveness Model. The Nursing Role Effectiveness Model,

Care received by community Access to care Performance of provider Performance of patient and family

Care by practitioners and other providers Technical knowledge Judgment skills Interpersonal

Amenities

Care implemented by patient Contribution of provider Contribution of patient and family

FIG 14-2 Various levels at which the quality of health care can be assessed. (From Donabedian, A. (1988). The quality of care: How can it be assessed? Journal of the American Medical Association, 260(12), 1744–1748.)

469CHAPTER 14 Outcomes Research

presented in Figure 14-3, was developed to guide conceptualization and research related to

nursing-sensitive outcomes. It also provided the theoretical basis for a systematic review of the

“state of the science on nursing-sensitive outcomes measurement” (Doran, 2011). The Nursing

Role Effectiveness Model is based on Donabedian’s (1987) quality framework and has three major

components—structure, the nurses’role, and patient and health outcomes. Structure in outcomes

has three subcomponents—nurse, organization, and patient. Nurse variables that influence the

quality of nursing care include factors such as experience level, knowledge, and skill level. Orga-

nizational components that can affect the quality of nursing care include staff mix, workload, and

assignment patterns. Patient characteristics that can affect the quality of care and outcomes include

health status, severity, and morbidity. The nurse’s role in outcomes has three subcomponents—

nurse’s independent role, nurse’s dependent role, and nurse’s interdependent role. Independent

role functions include assessment, diagnosis, nurse-initiated interventions, and follow-up care.

The patient and health outcomes of the independent role are clinical and symptom control, free-

dom from complications, functional status and self-care, knowledge of disease and its treatment,

satisfaction, and costs. The dependent role functions include execution of medical orders and

physician-initiated treatments. It is the dependent role functions that can lead to patient and health

outcomes of adverse events. Interdependent role functions include communication, case manage-

ment, coordination of care, and continuity, monitoring, and reporting. The interdependent role

results in team functioning and affects the patient and health outcomes of the independent role.

Patient and health outcomes are clearly interwoven into the entire care context. The propositions

of the Nursing Role Effectiveness Model are as follows (Irvine et al., 1998, p. 62):

• Nursing’s capacity to engage effectively in the independent, dependent, and interdependent role

functions is influenced by individual nurse variables, patient variables, and organizational

structure variables.

Structure

Nurse Experience Knowledge

Skills

Organizational Staff mix Workload

Assignment pattern

Patient Health status

Severity Morbidity

Nurses’ Independent Role

Assessment Diagnosis

Intervention Follow-up care

Communication Case management Coordination of care

Continuity/monitoring and reporting

Nurses’ Interdependent Role

Nurses’ Dependent Role

Execution of medical orders Physician-initiated treatments

Patient/Health Outcomes

Clinical/symptom control Freedom from complications Functional status/self-care Knowledge of disease and

its treatment satisfaction costs

Adverse events

Team functioning

FIG 14-3 Nursing Role Effectiveness Model. (From Irvine, D., Sidani, S., & Hall, L. M. (1998). Linking outcomes to nurses’ roles in health care. Nursing Economics, 16(2), 58–64.)

470 CHAPTER 14 Outcomes Research

• The nurse’s interdependent role function depends on the ability to communicate and articulate

her or his opinion to other members of the healthcare team.

• Nurse, patient, and system structural variables have a direct effect on clinical, functional, sat-

isfaction, and cost outcomes.

• The nurse’s independent role function can have a direct effect on clinical, functional, satisfac-

tion, and cost outcomes.

• Medication errors and other adverse events associated with the nurse’s dependent role function

can ultimately affect all categories of patient outcome.

• Nursing’s interdependent role function can affect the quality of interprofessional communication

and coordination, with the recognition that the nature of interprofessional communication and

coordination can influence other important patient outcomes and costs, such as risk-adjusted

length of stay, risk-adjusted mortality rates, excess home care costs following discharge,

unplanned visits to the physician or emergency department, and unplanned rehospitalization.

The Nursing Role Effectiveness Model (see Figure 14-3) provided a framework for conceptu-

alizing nursing-sensitive outcomes (Doran, 2011) and directed the selection of keywords that were

used in the systematic review of the state of the science on nursing-sensitive outcomes measure-

ment. The methodology and results of this systematic review are discussed next.

Conceptual and empirical research articles were included in the systematic review. Conceptual

papers were included if they discussed the definition and domains of a patient outcome concept,

or if they presented the results of a concept analysis designed to explicate the conceptual definition

and dimensions of the outcome concept. Empirical papers were included if they described the devel-

opment of an instrument to measure the outcome concept or evaluated the psychometric properties

of the instrument. Papers that reported results of studies that examined the relationship among nurs-

ing structural variables, nursing interventions, and outcomes were included. The review focused on

studies that were conducted in acute care, home care, primary care, and long-term care settings. For

each empirical paper, the authors made note of the date of publication, study design (e.g., random-

ized controlled trial [RCT], case control, prospective cohort, or descriptive), setting, sample,

response rate, and study limitations. This information was important for determining the general-

izability of the study results to specific clinical contexts (i.e., external validity) and for determining

threats to internal validity, such as response bias or the influence of confounding variables (see

Chapter 8 for a discussion of types of design validity). A confounding variable is an extraneous var-

iable whose presence affects the variables being studied so that the findings might not be an accurate

reflection of reality. Researchers select study designs to reduce the effect of extraneous variables. The

review also included information about the specific structural or nursing intervention variables and

their relationships with the outcome variables examined.

One of the results of this systematic review was the identification of nurse-sensitive patient out-

comes (Doran, 2011). A nursing-sensitive patient outcome (NSPO) is sensitive because it is influ-

enced by nursing care decisions and actions. It may not be caused by nursing but is associated with

nursing. In various situations, “nursing” might be the individual nurse, nurses as a working group,

approach to nursing practice, nursing unit, or institution that determines the numbers of nurses,

their salaries, educational levels of nurses, assignments of nurses, workload of nurses, management

of nurses, and policies related to nurses and nursing practice. It might even include the architecture

of the nursing unit. In whatever form, nursing actions have a role in the outcome, even though

acts of other professionals, organizational acts, and patient characteristics and behaviors

often are involved in the outcome. What patient outcomes can you think of that might be

nursing-sensitive? Examples of nursing-sensitive outcomes from Doran and colleagues’ review

and their definitions are summarized in Table 14-1.

471CHAPTER 14 Outcomes Research

ORIGINS OF OUTCOMES AND PERFORMANCE MONITORING

Florence Nightingale has been credited as being the first nurse to collect data to identify nursing’s

contribution to quality care and conduct research into patient outcomes (Magnello, 2010;

Montalvo, 2007). However, efforts to collect data systematically to assess outcomes in more mod-

ern times did not gain widespread attention in the United States until the late 1970s. At that time,

concerns about quality of care prompted the development of the Universal Minimum Health Data

Set, which was followed shortly thereafter by the Uniform Hospital Discharge Data Set (Kleib, Sales,

Doran, Mallette, & White, 2011). These data sets facilitated consistency in data collection among

healthcare organizations by prescribing the data elements to be gathered. The aggregated data were

then used to perform an assessment of quality of care in hospitals and provide information on

patients discharged from hospitals.

TABLE 14-1 NURSING-SENSITIVE PATIENT OUTCOMES AND DEFINITIONS

OUTCOME

CONCEPT DEFINITION

Functional status Functional status is a multidimensional construct that consists of, at least, behavioral (e.g.,

performance of activities of daily living), psychological (e.g., mood), cognitive (e.g.,

attention, concentration), and social (e.g., activities associated with roles) components

(Knight, 2000; Doran, 2011).

Self-care Self-care behavior entails the practice of actions or activities that individuals initiate and

perform, within time frames, on their own behalf in the interest of maintaining life,

healthy functioning, continued personal development, and well-being (Jenerette &

Murdaugh, 2008; Orem, 2001; Sidani, 2011a).

Symptoms “Symptoms refer to (a) sensations or experiences reflecting changes in a person’s

biopsychosocial functions, (b) a patient’s perception of an abnormal physical, emotional,

or cognitive state, (c) the perceived indicators of change in normal functioning, as

experienced by patients, or (d) subjective experience reflecting changes in the

biopsychosocial functioning, sensations, or cognition of an individual” (Sidani,

2011b, p. 132).

Pain Pain has been defined as “an unpleasant sensory and emotional experience associated

with actual or potential tissue damage, or described in terms of such damage”

(Merskey & Bogduk, 1994, p. 210).

Adverse outcome An adverse outcome is defined as consequence of injury caused by medical management

or complication rather than by the underlying disease itself, and generally includes

prolonged health care, a resulting disability, or death at the time of discharge (WHO,

2009).

Psychological

distress

Psychological distress has been defined as “the emotional condition that one feels in

response to having to cope with situations that are unsettling, frustrating, or perceived as

harmful or threatening” (Lazarus & Folman’s work as cited in Howell, 2011, p. 289).

Patient

satisfaction

“Patient satisfaction is frequently defined as the extent to which patients’ expectations of

care match the actual care received” (Spence Laschinger, Gilbert, & Smith, 2011, p. 362).

Mortality rate Mortality, in its simplest meaning, reflects death. “When examining death as a quality-of-

care outcome, rates of death are examined for specific patient samples or populations”

(Tourangeau, 2011, p. 411).

Healthcare

utilization

“Healthcare utilization can be thought of as the sum or aggregate of services consumed by

patients in their attempts to maintain or regain a level of health status, along with the

costs of these services” (Clarke, 2011, p. 441).

472 CHAPTER 14 Outcomes Research

Over time, other countries developed similar data sets. In Canada, “Standards for Management

Information Systems” (MIS) were developed in the 1980s. With the establishment of the Canadian

Institute for Health Information (CIHI) in 1994, the MIS became a set of national standards used to

collect and report financial and statistical data from health service organizations’ daily operations

(CIHI, 2012). Simultaneously, CIHI implemented a national Discharge Abstract Database

(DAD), which has become a key resource in outcomes research. However, those data sets did not

include information about nursing care delivered to patients in the hospital (Kleib et al., 2011).

Without that information, the contribution of nursing care to patient, organizational, and system

outcomes was rendered invisible. This major gap in information was addressed by the development

of nursing minimum data sets in the United States, Canada, and other countries worldwide.

FEDERAL GOVERNMENT INVOLVEMENT IN OUTCOMES RESEARCH

There are now several national outcomes’ initiatives in the United States and other countries focused

onthedevelopmentofmethodsformeasuringandreporting patienthealthoutcomes.Weprovidean

overviewonsomeofthenationaloutcomeinitiativesintheUnitedStates,startingwiththeworkofthe

AHRQ, and then focus specifically on examples of national nursing outcome initiatives. These initia-

tives are paving the way for outcomes research by building tools and methodologies for measuring

patient outcomes and building large secondary databases that are sources for outcomes research.

Agency for Healthcare Research and Quality (AHRQ) The AHRQ, as a part of the U.S. Department of Health and Human Services (DHHS), supports

research designed to improve the outcomes and quality of health care, reduce healthcare costs,

address patient safety and medical errors, and broaden access to effective services. The AHRQ web-

site (http://www.ahrq.gov) is a valuable source of information about outcomes research, funding

opportunities, and results of recently completed research, including nursing research. In 2010, the

AHRQ was awarded $25 million in funding to support efforts by states and health systems to

implement and evaluate patient safety approaches and medical liability reform models. In addi-

tion, AHRQ invested $17 million to expand projects to help prevent health care–associated infec-

tions (HAIs), the most common complication of hospital care. The AHRQ initiated several major

research efforts to examine medical outcomes and improve quality of care. One of the most current

initiatives is comparative effectiveness research, which is described in the next section.

American Recovery and Reinvestment Act Funding from the American Recovery and Reinvestment Act (Recovery Act), signed into law in

2009, allowed AHRQ to expand its work in support of comparative effectiveness research, includ-

ing enhancing the Effective Health Care Program. A total of $473 million was designated for fund-

ing patient-centered outcomes research (AHRQ, 2010). The AHRQ program provides patients,

clinicians, and others with evidence-based information to make informed decisions about health

care through activities such as comparative effectiveness reviews conducted through AHRQ’s

Evidence-Based Practice Center (EPC). The AHRQ has a broad research portfolio that involves

almost every aspect of health care, including:

• Clinical practice

• Outcomes and effectiveness of care

• Evidence-based practice

• Primary care and care for priority populations

• Healthcare quality

473CHAPTER 14 Outcomes Research

• Patient safety and medical errors

• Organization and delivery of care and use of healthcare resources

• Healthcare costs and financing

• Health information technology

• Knowledge transfer

National Quality Forum The National Quality Forum (NQF) was created in 1999 as a national standard-setting organiza-

tion for healthcare performance measures (NQF, 2013a). The NQF portfolio of voluntary consen-

sus standards includes performance measures, serious reportable events, and preferred practices

(i.e., safe practices). A complete list of measures included in the NQF portfolio can be found online

(http://www.qualityforum.org/Measures_Reports_Tools.aspx). Approximately one third of the

measures in NQF’s portfolio are measures of patient outcomes, such as mortality, readmissions,

health functioning, depression, and experience of care. The NQF includes several nursing-sensitive

measures in its performance measurement portfolio. Those that were submitted by the American

Nurses Association (ANA) under the National Database of Nursing Quality Indicators (see later)

include the following:

• Nursing staff skill mix

• Nursing hours per patient day

• Catheter-associated urinary tract infection (UTI) rate

• Central line–associated bloodstream infection rate

• Fall and injury rates

• Hospital- and unit-acquired pressure ulcer rates

• Nurse turnover rate

• RN practice environment scale

• Ventilator-associated pneumonia rate

These indicators are the first nationally standardized performance measures of nursing-

sensitive outcomes in acute care hospitals and are designed to assess healthcare quality, patient

safety, and a professional and safe work environment. Although most of the measures in use focus

on the failure to meet expected standards, the NQF believes that quality is as much about influenc-

ing positive outcomes as about avoiding negative outcomes. Therefore, the NQF is currently devel-

oping national standards to evaluate the quality of health care based on how patients feel. It notes

that “national quality assessment programs usually measure and reward practices based on

improving clinical processes such as re-hospitalization or infection rates. While this type of infor-

mation is important and useful to clinicians, it doesn’t always take into account what is most

important to the patient and families of the patient receiving care, such as the management of

long-term symptoms or ability to conduct daily activities” (NQF, 2013b).

National Database of Nursing Quality Indicators In 1994, the ANA, in collaboration with the American Academy of Nursing Expert Panel on Qual-

ity Health Care, launched a plan to identify indicators of quality nursing practice and collect and

analyze data using these indicators throughout the United States (Mitchell, Ferketich, & Jennings,

1998). The goal was to identify and/or develop nursing-sensitive quality measures. Donabedian’s

theory was used as the framework for the project. Together, these indicators were referred to as the

ANA Nursing Care Report Card, which could facilitate benchmarking or setting a desired stan-

dard that would allow comparisons of hospitals in terms of their nursing care quality.

474 CHAPTER 14 Outcomes Research

In 1998, the ANA provided funding to develop a national database to house data collected using

nursing-sensitive quality indicators. This became the National Database of Nursing Quality Indi-

cators (NDNQI; Montalvo, 2007). Participation in NDNQI meets requirements for the Magnet

Recognition Program, and 20% of database members participate for that reason (see Chapters

1 and 13 for a discussion of Magnet status). Detailed guidelines for data collection, including def-

initions and decision guides, are provided by the NDNQI (2013). The NDNQI nursing-sensitive

indicators are summarized in Table 14-2.

TABLE 14-2 AMERICAN NURSES ASSOCIATION NATIONAL DATABASE OF NURSING QUALITY INDICATORS

INDICATOR SUBINDICATOR MEASURE

1. Nursing hours per patient day* ,{

a. Registered nurse (RN)

b. Licensed practical nurse, licensed

vocational nurse (LPN, LVN)

c. Unlicensed assistive personnel UAP)

Structure

2. Patient falls* ,{

Process and

outcome

3. Patient falls with injury*,{ a. Injury level Process and

outcome

4. Pediatric pain assessment, intervention,

reassessment (AIR) cycle

Process

5. Pediatric peripheral intravenous infiltration

rate

Outcome

6. Pressure ulcer prevalence a. Community-acquired

b. Hospital-acquired

c. Unit-acquired

Process and

outcome

7. Psychiatric physical and sexual assault rate Outcome

8. Restraint prevalence{ Outcome

9. RN education/certification Structure

10. RN satisfaction survey options*,{ a. Job satisfaction scales

b. Job satisfaction scales short form

c. Practice environment scale (PES){

Process and

outcome

11. Skill mix: Percentage of total nursing hours

supplied by ANA and NQF*,{ a. RN

b. LPN, LVN

c. UAP

d. No. of total nursing hours supplied by

agency staff (%)

Structure

12. Voluntary nurse turnover{ Structure

13. Nurse vacancy rate Structure

14. Nosocomial infections

a. Urinary catheter–associated urinary tract

infection (UTI) {

b. Central line catheter–associated

bloodstream infection (CABSI)*,{

c. Ventilator-associated pneumonia (VAP) {

Outcome

*Original ANA nursing-sensitive indicator. {NQF-endorsed nursing-sensitive indicator. { The RN survey is annual, whereas the other indicators are quarterly.

475CHAPTER 14 Outcomes Research

Other organizations currently involved in efforts to study nursing-sensitive outcomes include

the Collaborative Alliance for Nursing Outcomes California Database (CALNOC, 2013a), Center

for Medicare & Medicaid Services (CMS) Hospital Quality Initiative, American Hospital Associ-

ation, the Federation of American Hospitals, The Joint Commission and, in Canada, the Canadian

Nurses Association National Nursing Quality Report. For further information on these outcome

initiatives, you can review Doran, Mildon, and Clarke’s (2011) knowledge synthesis of the state of

science on nursing outcomes measurement and international nursing report card initiatives. This

knowledge synthesis was a review of nursing-sensitive outcome and report card initiatives in the

United States, Canada, United Kingdom, and Belgium.

Oncology Nursing Society The Oncology Nursing Society (ONS, 2012) is a professional organization of more than 35,000

RNs and other healthcare providers dedicated to excellence in patient care, education, research,

and administration in oncology nursing. The ONS has taken a leadership role among specialty

nursing organizations in developing an evidence-based practice (EBP) resource area on its website

(http://www.ons.org/ClinicalResources). The site provides nurses with a guide to identify, critically

appraise, and use evidence to solve clinical problems. The ONS website also assists nurses, in par-

ticular advanced practice nurses, who are helping others develop EBP protocols. The outcomes

resource area is helpful to nurses for achieving desired outcomes for people with cancer by pro-

viding outcome measures, resource cards, and evidence tables.

ADVANCED PRACTICE NURSING OUTCOMES RESEARCH

Demonstrating the value of advanced practice nurses’ (APNs) roles within the healthcare system

has been the focus of much of the outcomes research in nursing, probably because advance practice

roles are often under threat when healthcare organizations restructure under cost constraints or

when new advanced practice roles are first introduced, as was the case with the nurse practitioner

role. Therefore, we review some of the outcomes research related to advanced practice nursing in

this next section.

The ANA recognizes four types of APNs—certified registered nurse anesthetists (CRNAs), cer-

tified nurse-midwives (CNMs), clinical nurse specialists (CNSs), and nurse practitioners (NPs).

Studying APNs requires a determination of what happens during the process of APN care. This

care involves a set of activities within, among, and between practitioners and patients and includes

technical and interpersonal elements. The process of care is complex and somewhat mysterious.

However, clearly describing what occurs during the process is essential to developing a compre-

hensive understanding of how APNs affect outcomes.

There is abundant research demonstrating the safety and effectiveness of APNs. DiCenso and

colleagues (2010) conducted a search of all RCTs ever published, comparing APNs to usual care in

terms of patient, provider, and/or health system outcomes. They found a total of 78 trials—28 of

primary care NPs, 17 of acute care NPs, 32 of CNSs, and one of a combined CNS-NP role. Findings

consistently showed that care by APNs resulted in equivalent or improved outcomes. Moore and

McQuestion (2012) conducted a systematic review of the outcomes of the CNS role, focusing on

chronic disease patient populations. Many of the studies showed that CNSs had a positive impact

on patients living with chronic illnesses. Key outcomes included an improvement in quality of life,

patient and health provider satisfaction, fewer and shorter rehospitalizations, and lower costs of

care. Examples of outcomes that have been found to be sensitive to APN processes of care are sum-

marized in Table 14-3.

476 CHAPTER 14 Outcomes Research

OUTCOMES RESEARCH AND NURSING PRACTICE

Outcome studies provide rich opportunities to build a stronger scientific underpinning for nurs-

ing practice. Nurse researchers have been actively involved in the effort to examine the outcomes of

patient care. Ideally, we would like to understand the outcomes of nursing practice within a one to

one nurse-patient relationship; however, in most cases, the nursing effect is shared because more

than one nurse cares for a patient. In addition, nurse managers and nurse administrators have

control over the nursing staff and the environment of nursing practice, and this control affects

the autonomy of the nurse to implement practice. Consequently, outcomes research must first

focus on how nursing care is organized, rather than on what nurses do. When that occurs, we

may begin to determine how what nurses do influences patient outcomes (Lake, 2006). In the next

section of this chapter, we provide a description of approaches to evaluating outcomes, structural

variables, and processes of care.

Evaluating Outcomes of Care The goal of outcomes research is the evaluation of outcomes as defined by Donabedian; however,

this goal is not as easily realized. Donabedian’s (1987) theory requires that identified outcomes be

clearly linked with the process that caused the outcome. Researchers need to define the process and

justify the causal links with the selected outcomes. The identification of desirable outcomes of care

requires dialogue between the recipients and providers of care. Although the providers of care may

delineate what is achievable, the recipients of care must clarify what is desirable. A desirable out-

come would address issues of specific concern to patients, such as long-term symptoms or ability

to conduct activities of daily living. The outcomes must also be relevant to the goals of the health

professionals, healthcare system of which the professionals are a part, and society.

Outcomes are time-dependent. Some outcomes may not be apparent for a long period after the

process that is purported to have caused them, whereas others may be identified immediately.

Some outcomes are temporary, and others are permanent. Therefore, an appropriate time frame

must be established for determining the selected outcomes.

TABLE 14-3 OUTCOMES ASSOCIATED WITH ADVANCED PRACTICE NURSES’ PROCESSES OF CARE

OUTCOMES EXAMPLES

Patient outcomes Disease- or condition-specific outcomes, such as changes in signs of disease:

• Physical symptoms

• Psychosocial outcomes

• Prevention of complications of treatment

• Self-management

• Patient satisfaction

Organizational outcomes Unit or hospital length of stay—total healthcare costs

Nursing outcomes Improvement in nursing knowledge and skills

Enhancing nursing participation in continuing professional development

Increasing nursing job satisfaction

From Doran, D. M., Sidani, S., & Di Pietro, T. (2010). Nursing-sensitive outcomes. In J. S. Fulton, B. Lyon, & K. Goudreau

(Eds.), Foundations of clinical nurse specialist practice (pp. 35-37). New York: Springer.

477CHAPTER 14 Outcomes Research

A final issue in outcomes evaluation is determining attribution. This requires assigning the

place and degree of responsibility for the outcomes observed. Many factors other than health care

may influence outcomes, and precautions must be taken to hold constant all the significant factors,

other than healthcare factors, or to account for their effect if valid conclusions can be drawn from

outcomes research. A particular outcome is often influenced by a multiplicity of factors. Patient

factors such as compliance, predisposition to disease, age, propensity to use resources, high-risk

behaviors (e.g., smoking, poor dietary habits, drug abuse), and lifestyle, must be taken into

account. Environmental factors such as air quality, public policies related to smoking, and occu-

pational hazards must be included. The responsibility for outcomes may be distributed among the

providers, patients, employers, insurers, community, and government.

There is as yet little scientific basis for judging the precise relationship between each of these

complicating factors and the selected outcome. Many of the influencing factors may be outside

the jurisdiction or influence of the healthcare system or of the providers within it. One way to

address this problem of identifying relevant outcomes is to define a set of proximal outcomes spe-

cific to the condition for which care is being provided. A proximal outcome is an outcome that is

close to the delivery of care. An example of a proximal outcome is signs and symptoms of disease

(Brenner, Curbow, & Legro, 1995). A distal outcome is removed from proximity to the care or a

service received and is more influenced by external (nontreatment) factors than a proximal out-

come. Quality of life is an example of a distal outcome.

Outcomes studies being conducted at this time do not examine patient care at the individual

nurse or individual patient level, as occurs in many nursing studies; rather, for example, they might

examine all the nursing care provided to patients in a particular intensive care unit. Some of the

questions researchers might ask in an outcome study include the following:

• What are the end results of patients’ care (all care provided by all care providers)?

• What effect does nursing care (all care by all nurses) have on the end results of a patient’s care?

• Are there some nursing acts that have no effects at all on outcomes or that actually cause harm?

• Can we measure and thus identify the end results of nursing care?

• How do we distinguish care provided by nurses from care provided by other professionals in

examining patient outcomes?

• When do we measure the effects of care, the end results (e.g., change in symptoms, function-

ing, or quality of life)—immediately after the care, when the patient is discharged, or

much later?

Evaluating Structure of Care The elements of organization and administration, as well as provider and patient characteristics

that guide the processes of care, are referred to as the structures of care. We know that the orga-

nization of nursing care and nursing leadership have an effect on nursing practice and, in turn, on

patient outcomes. These are called structural variables in Donabedian’s (1987) Theory of Quality.

In a more recent study, Kramer, Maguire, and Schmalenberg (2006) indicated that a growing body

of evidence supports a relationship between empowered shared leadership and governance struc-

ture and the implementation of nursing practice. Autonomy in clinical nursing practice, another

structural variable, is also being recognized as critically important to achieving positive patient

outcomes. It is important therefore to identify autonomy-enabling structural variables in the orga-

nizational structures of nursing practice. One such structure, determined by a number of nursing

studies, is the Magnet hospital designation. To check the status of a particular hospital regarding its

recognition for excellence in nursing care, you can search for Magnet hospitals on the American

Nurses Credentialing Center (ANCC) website (http://www.nursecredentialing.org/Magnet/

FindaMagnetFacility.aspx).

478 CHAPTER 14 Outcomes Research

The first step in evaluating structure of care is to identify and describe the elements of the struc-

ture. Various administration and management theories can be used to identify these elements.

They might include leadership, organizational hierarchy, decision-making processes, distribution

of power, financial management, and administrative decision-making processes. Nurse researchers

investigating the influence of structural variables on quality of care and outcomes have studied

factors such as nurse staffing, nursing education, nursing work environment, hospital character-

istics, and organization of care delivery (Table 14-4).

TABLE 14-4 STUDIES INVESTIGATING THE RELATIONSHIP BETWEEN STRUCTURAL VARIABLES AND OUTCOMES

YEAR STUDY

2013 McHugh, M.D., Kelly, L.A., Smith, H.L., Wu, E.S., Vanak, J.M., & Aiken, L.H. (2013). Lower mortality in

Magnet hospitals. Medical Care, 51(5), 382-388.

2013 Ausserhofer, D., Schubert, M., Desmedt, M., Blegen, M.A., De Geest, S., & Schwendimann, R.

(2013). The association of patient safety climate and nurse-related organizational factors with

selected patient outcomes: A cross-sectional survey. International Journal of Nursing Studies, 50(2),

240-252.

2012 Yang, P.H., Hung, C.H., Chen, Y.M., Hu, C.Y., & Shieh, S.L. (2012). The impact of different nursing skill

mix models on patient outcomes in a respiratory care center. Worldviews on Evidence-Based

Nursing, 9(4), 227-233.

2012 Twigg, D., Duffield, C., Bremner, A., Rapley, P., & Finn, J. (2012). Impact of skill mix variation on patient

outcomes following implementation of nursing hours per patient day staffing: A retrospective study.

Journal of Advanced Nursing, 68(12), 2710-2718.

2011 McHugh, M. D., Shang, J., Sloane, D. M., & Aiken, L. H. (2011). Risk factors for hospital-acquired ‘poor

glycemic control’: A case control study. International Journal for Quality in Health Care, 23(1), 44-51.

2011 Trinkoff, A. M., Johantgen, M., Storr, C. L., Gurses, A. P., Liang, Y., & Han, K. (2011). Nurses’ work

schedule characteristics, nurse staffing, and patient mortality. Nursing Research, 60(1), 1-8.

2010 Flynn, L., Liang, Y., Dickson, G. L., & Aiken, L. H. (2010). Effects of nursing practice environments on

quality outcomes in nursing homes. Journal of the American Geriatrics Society, 58(12), 2401-2406.

2010 Fries, C. R., Earle, C. C., & Silber, J. H. (2010). Hospital characteristics, clinical severity, and outcomes

for surgical oncology patients. Surgery, 147(5), 602-609.

2010 Cummings, G. G., Midodzi, W. K., Wong, C. A., & Estabrooks, C. A. (2010). The contribution of hospital

nursing leadership styles to 30-day patient mortality. Nursing Research, 59(5), 331-339.

2009 Silber, J. H., Rosenbaum, P. R., Romano, P. S., Rosen, A. K., Wang, Y., Teng, Y., et al. (2009). Hospital

teaching intensity, patient race, and surgical outcomes. Archives of Surgery, 144(2), 113-120.

2008 Kutney-Lee, A., & Aiken, L. H. (2008). Effect of nurse staffing and education on the outcomes of

surgical patients with comorbid serious mental illness. Psychiatric Services, 59(12), 1466-1469.

2007 Castle, N. G., & Engberg, J. (2007). The influence of staffing characteristics on quality of care in nursing

homes. Health Services Research, 42(5), 1822-1847.

2007 Goldman, L. E., Vittinghoff, E., & Dudley, R. A. (2007). Quality of care in hospitals with a high percent of

Medicaid patients. Medical Care, 45(6), 579-583.

2007 Standing, M. (2007). Clinical decision-making skills on the developmental journey from student to

registered nurse: A longitudinal inquiry. Journal of Advanced Nursing, 60(3), 257-269.

2006 Mor, V. (2006). Defining and measuring quality outcomes in long-term care. Journal of the American

Medical Directors Association, 7(8), 532-538.

2006 Rubin, F. H., Williams, J. T., Lescisin, D. A., Mook, W. J., Hassan, S., & Innouye, S. K. (2006).

Replicating the Hospital Elder Life Program in a community hospital and demonstrating effectiveness

using quality improvement methodology. Journal of the American Geriatrics Society, 54(6), 969-974.

479CHAPTER 14 Outcomes Research

The second step is to evaluate the impact of various structural elements on the process of care

and on outcomes. This evaluation requires a comparison of different structures that provide the

same processes of care. In evaluating structures, the unit of measure is the structure. The evaluation

requires access to a sufficiently large sample of “like” structures, with similar processes and out-

comes, which can then be compared with a sample of another structure providing the same pro-

cesses and examining the same outcomes. For example, in nursing research, nurses might want to

compare various structures providing primary health care, such as the private physician office,

health maintenance organization (HMO), rural health clinic, community-oriented primary care

clinic, and nurse-managed center. Alternatively, nurse researchers might examine nursing care

provided within the structures of a private outpatient surgical clinic, private hospital, county hos-

pital, and teaching hospital associated with a health science center. In each of these examples,

the focus of research would be the impact of structure on the processes and outcomes of care.

Table 14-4 lists some current outcomes studies that have examined the impact of structure of care

on patient outcomes.

In the United States, nursing homes, home healthcare agencies, and hospitals are required to

collect specifically measured quality variables and to report them to the federal government. This

mandate was established because of considerable variation in the quality of care in these structures.

Various government agencies analyze the quality of these structures so that they can adequately

oversee the quality of care provided to the U.S. public. These data are made available to the general

public so that individuals can make their own determination of the quality of care provided by

various nursing homes, home healthcare agencies, and hospitals. Researchers can also access these

data for studies of the quality of various structures. To access these data on the Internet, you can

search using the phrases “nursing home compare,” “home health compare,” and “hospital com-

pare.” In addition to being able to select a specific hospital, nursing home, or home healthcare

agency, you can access considerable general information about quality related to each of these

structures of health care.

Evaluating Process of Care Clinical management has been an art rather than a science for most health professionals. Under-

standing the process sufficiently to study it must begin with careful reflection, dialogue, and obser-

vation. There are multiple components of clinical management, many of which have not yet been

clearly defined or tested. Three components of process that are of particular interest to Donabedian

(1982, 1987) are standards of care, practice styles, and costs of care. Standards of care and practice

styles are included in the following sections but costs of care are discussed later in this chapter, with

the methodologies of evaluation.

Standards of Care A standard of care is a norm on which quality of care is judged. Clinical guidelines, critical paths,

and care maps define standards of care for particular situations. In that regard, Donabedian (1987)

recommended the development of specific criteria to be used as a basis for judging the quality of

care. These criteria may take the form of clinical guidelines or care maps based on prior validation

that the care contributed to the desired outcomes. The clinical guidelines published by the AHRQ

(2011) established norms or standards against which the validity of clinical management can be

judged. These norms are now established through clinical practice guidelines available through the

National Guideline Clearinghouse (NGC) within the AHRQ (see http://www.guideline.gov).

Chapter 13 provides a detailed discussion of the NGC and its resources.

480 CHAPTER 14 Outcomes Research

Practice Styles, Practice Pattern, and Evidence-Based Practice

The style of a practitioner’s practice is another dimension of the process of care that influences

quality; however, it is problematic to judge what constitutes goodness in style and to justify the

decisions made regarding it. Practice pattern is a concept closely related to practice style. Practice

style represents variation in how care is provided, whereas practice pattern represents variation in

what care is provided.

EBP is another dimension of the process of care that is considered a critical aspect of profes-

sional practice (Stetler & Caramanica, 2007). The ultimate goals of EBP are improved patient

health status and quality of care (Graham, Bick, Tetroe, Strause, & Harrison, 2011). Therefore,

the impact of EBP should be assessed through the measurement of patient outcomes. Very few

empirical studies have assessed the impact of evidence-based nursing practice on patient out-

comes. One of them, a study by Davies, Edwards, Ploeg, and Virani (2008), found that implemen-

tation of best practice guidelines in nursing resulted in improved outcomes in diverse settings, but

there was considerable variability in the indicators evaluated, suggesting the need for more

research in this area. Table 14-5 lists some outcomes studies that have examined the impact of

process of care on patient outcomes.

METHODOLOGIES FOR OUTCOMES STUDIES

Outcomes research methodologies have been developed to link the care that people receive with

the results they experience, thereby providing better ways to monitor and improve the quality of

care (Clancy & Eisenberg. 1998). This section describes some of the current methodologies used in

conducting outcomes research, including sampling methods, research strategies or designs, mea-

surement processes, and statistical approaches. These descriptions are not sufficient to guide you in

using the approaches described; rather, they provide a broad overview of the variety of method-

ologies you will see in outcomes studies. This knowledge will help you understand and critically

appraise the methodologies used in published outcomes studies. For additional information, you

can refer to the citations in each section and to other sources of outcomes research (Doran, 2011;

Grove, Burns, & Gray, 2013). Outcomes studies cross a variety of disciplines; therefore, the emerg-

ing methodologies are being enriched by a cross-pollination of ideas, some of which are new to

nursing research.

Samples and Sampling The preferred methods of obtaining samples are different in outcomes studies. Random sampling

is seldom used, with the exception of an RCT, when a specific intervention or healthcare service is

being evaluated. Usually, heterogeneous samples (with varied types of patients), rather than homo-

geneous (with similar patients) samples, are obtained in outcomes research. Rather than using

sampling criteria, which restrict subjects included in the study to decrease possible biases, reduce

the variance, and increase the possibility of identifying a statistically significant difference, out-

comes researchers seek large heterogeneous samples that reflect, as much as possible, all patients

who would be receiving care in a real healthcare context. For example, samples need to include

patients with various comorbidities and patients with varying levels of health status. In addition,

individuals should be identified who do not receive treatment for their condition.

Devising ways to evaluate the representativeness of such samples is problematic. For a sample

to be representative, it must be as much like the target population as possible, particularly in

relation to the variables being studied. Because the target population in outcomes research is

often heterogeneous, there are a large number of variables for which sample representativeness

481CHAPTER 14 Outcomes Research

needs to be determined. Another challenge in outcomes research is to develop strategies for locat-

ing untreated individuals and including them in follow-up studies. The intent is to determine

whether outcomes differ between those treated and those untreated. To address some of these

challenges, outcomes researchers have used large databases as sample sources in observational

research designs.

TABLE 14-5 STUDIES INVESTIGATING THE RELATIONSHIP BETWEEN PROCESS VARIABLES AND OUTCOMES

YEAR STUDY

2013 Effken, J.A., Gephart, S.M., Brewer, B.B., & Carley, K.M. (2013). Using ORA, a network analysis tool, to

assess the relationship of handoffs to quality and safety outcomes. CIN: Computers, Informatics,

Nursing, 31(1), 36-44.

2012 Rosted, E., Wagner, L, Hendriksen, C., & Poulsen, I. (2012). Geriatric nursing assessment and

intervention in an emergency department: A pilot study. International Journal of Older People

Nursing, 7(2), 141-151.

2012 Cossette, S., Frasure-Smith, N., Dupuis, J., Juneau, M., & Guertin, M.C. (2012). Randomized controlled

trial of tailored nursing interventions to improve cardiac rehabilitation enrollment. Nursing Research,

61(2), 111-120.

2012 Sermeus, M.J., Park, J.S., & Park, H. (2012). Effect of sleep-inducing music on sleep in persons with

percutaneous transluminal coronary angiography in the cardiac care unit. Journal of Clinical Nursing,

21(5-6), 728-735.

2012 Yuenyong, S., O’Brien, B., & Jirapeet, V. (2012). Effects of labour support from close female relative on

labor and maternal satisfaction in a Thai setting. Journal of Obstetric, Gynecologic, & Neonatal

Nursing, 41(1), 45-56.

2012 Ruesch, C., Mossakowski, J., Forrest, J., Hayes, M., Jahrsdoerfer, M., Comeau, E., & Singleton, M.

(2012). Using nursing expertise and telemedicine to increase nursing collaboration and improve

patient outcomes. Telemedicine Journal & E-Health, 18(8), 591-595.

2010 Sidani S., & Doran, D. (2010). Relationships between processes and outcomes of nurse practitioners in

acute care: An exploration. Journal of Nursing Care Quality, 25(1), 31-38.

2010 Poochikian-Sarkissian, S., Sidani, S., Ferguson-Paré, M., & Doran, D. (2010). Examining the relationship

between patient-centred care and outcomes. Canadian Journal of Neuroscience Nursing 32(4),

14-21.

2006 Kutzleb, J., & Reiner, D. The impact of nurse-directed patient education on quality of life and functional

capacity in people with heart failure. Journal of the American Academy of Nurse Practitioners, 18(3),

116-123.

2006 Sidani, S., Doran, D.M., Porter, H., LeFort, S., O’Brien-Pallas, L., Zahn, C., Laschinger, H., &

Sarkissian, S. (2006). Processes of care: Comparison between nurse practitioners and physician

residents in acute care. Canadian Journal of Nursing Leadership 19(1), 69-85.

2006 Doran, D.M., Harrison, M., Spence-Laschinger, H., Hirdes, J., Rukholm, E., Sidani, S., McGillis Hall, L., &

Tourangeau, A. (2006a). Nursing-sensitive outcomes data collection in acute care and long-term care

settings. Nursing Research, 55(2S), S75-S81.

2006 Doran, D.M., Harrison, M., Spence-Laschinger, H., Hirdes, J., Rukholm, E., Sidani, S., McGillis Hall, L., &

Tourangeau, A., & Cranley, L. (2006b). Relationship between nursing interventions and outcome

achievement in acute care settings. Research in Nursing & Health, 29(1), 61-70.

2003 Doran, D.M., O’Brien-Pallas, L., Sidani, S., McGillis Hall, L., Petryshen, P., Hawkins, J., Watt-Watson, J.,

& Thompson, D. (2003). An evaluation of nursing sensitive outcomes for quality care. Journal of

International Nursing Perspectives, 3(3), 109-125.

482 CHAPTER 14 Outcomes Research

Large Databases as Sample Sources

One source of samples for outcomes studies is large databases. As illustrated in Figure 14-4, two

broad categories of databases emerge from patient care encounters, clinical databases and admin-

istrative databases (Waltz, Strickland, & Lenz, 2010).

Clinical databases are created by providers such as hospitals, HMOs, accountable care orga-

nizations, and healthcare professionals. The clinical data are generated as a result of routine doc-

umentation of care or in relation to a research protocol. Some databases are data registries that

have been developed to gather data related to a particular disease, such as heart disease or cancer

(Lee & Goldman, 1989). With a clinical database, you can link observations made by many prac-

titioners over long periods of time. Links can be made between the process of care and outcomes

(Mitchell et al., 1994; Moses, 1995).

Administrative databases are created by insurance companies, government agencies, and

others not directly involved in providing patient care. Administrative databases have standardized

sets of data for enormous numbers of patients and providers (McDonald & Hui, 1991). An exam-

ple is the Medicare database managed by the CMS. The administrative databases can be used to

determine the incidence or prevalence of disease, geographic variations in medical care use, char-

acteristics of medical care, and outcomes of care. Examples of large database indicators used to

assess the quality of care are provided in Table 14-6. Initiatives such as CALNOC (2013b) and

NDNQI (2013; Montalvo, 2007) are making nursing data more accessible for large database

research.

Study Designs Although RCTs are considered the gold standard for clinical research, most outcomes studies use

quasi-experimental or observational research designs, which are suitable for addressing questions

of effectiveness and efficiency. Like RCTs, outcomes research sometimes seeks to provide evidence

about which interventions work best for which types of patients and under what circumstances.

However, the “intervention” being evaluated is not limited to medications or new clinical proce-

dures, but may also include the provision of particular services or resources, or even the enforcing

of specific policies and regulations, by legislative and financial bodies. Outcomes research often

considers additional parameters such as cost, timeliness, convenience, geographic accessibility,

Patient care encounter

Clinical data Administrative data

Large clinical databases Computerized medical records

Disease or organ-specific databases

Large administrative databases Insurance claims databases Tumor or disease registries Vital statistics databases

FIG 14-4 Types of databases emanating from patient care encounters. (From Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of nursing research: Appraisal, synthesis, and generation of evidence (7th ed.). St. Louis: Elsevier Saunders.)

483CHAPTER 14 Outcomes Research

and patient preferences. In the next section, common types of designs used in outcomes research

are briefly discussed.

Prospective Cohort Studies

A prospective cohort study is an epidemiological study in which the researcher identifies a group

of people who are at risk for experiencing a particular event and then follows them over time to

observe whether or not the event occurs. Sample sizes for these studies often must be very large,

particularly if only a small portion of the at-risk group will experience the event. The entire group

is followed over time to determine the point at which the event occurs, variables associated with the

event, and outcomes for those who experienced the event in comparison with those who did not.

TABLE 14-6 SOME LARGE DATABASE INDICATORS USED TO MONITOR NURSING STRUCTURAL, PROCESS, AND OUTCOME INDICATORS

TYPE OF

INDICATOR INDICATOR SOURCE

Structural Nursing (e.g., RN,

LPN, UAP) hours per

patient day

National Database Nursing Quality Indicators (NDNQI, 2013)

Collaborative Alliance for Nursing Outcomes (CALNOC, 2013a)

National Quality Forum (NQF, 2013b)

Staff mix (RN, LPN,

LVN, UAP)

NDNQI (2013)

CALNOC (2013a)

NQF (2013)

Nurse turnover NDNQI (2013)

CALNOC (2013a)

NQF (2013)

RN practice environment NDNQI (2013)

NQF (2013b)

Process Risk assessment for

pressure ulcers

CALNOC (2013a)

Physical restraints NDNQI (2013)

CALNOC (2013a)

Prevention protocols in

place

CALNOC (2013a)

B-NMDS (Belgian nursing minimum data set; Sermeus et al.,

2008; Van den Heede, et al., 2009)

Medication administration

accuracy

CALNOC (2013a)

Outcome Patient falls, injury falls NDNQI (2013)

CALNOC (2013a)

NQF (2013b)

Catheter-associated

urinary tract infection rate

NDNQI (2013)

NQF (2013)

Hospital-acquired

pressure ulcer

NDNQI (2013)

CALNOC (2013a)

NQF (2013b)

Central line–associated

bloodstream

infection rate

NDNQI (2013)

CALNOC (2013a)

NQF (2013b)

LPN, Licensed practical nurse; LVN, licensed vocational nurse; RN, registered nurse; UAP, unlicensed assistive personnel.

484 CHAPTER 14 Outcomes Research

The Harvard Nurses’ Health Study is an example of a prospective cohort study. This study

recruited 100,000 nurses to determine the long-term consequences of the use of birth control pills.

Every 2 years, or more often, nurses complete a questionnaire about their health and health behav-

iors. The study has now been in progress for more than 20 years. Multiple studies reported in the

literature have used the large data set yielded by the study. The following summary describes a

prospective cohort study on smoking and the risk of psoriasis in women. It uses the Nurses’ Health

Study II, a second study using a younger population than that in the Harvard study (Setty, Curhan,

& Choi, 2007). The researchers were able to obtain an extremely large heterogeneous sample for

their study by using data from the Nurses’ Health Study:

“Background: Psoriasis is a common, chronic, inflammatory skin disorder. Smoking may

increase the risk of psoriasis.

Methods: Over a 14-year time period from 1991 to 2005, the relation between smoking status,

duration, intensity, cessation, exposure to second-hand smoke, and incident of psoriasis was pro-

spectively examined in 78,532 women from the Nurses’ Health Study II. The primary outcome

was incident, self-reported, physician-diagnosed psoriasis.

Results: Eight-hundred-eighty-seven incident cases of psoriasis were documented. The multi-

variate relative risk (RR) of psoriasis was 1.78 (95% confidence interval [CI], 1.46 to 2.16) for

current smokers and 1.37 (95% CI, 1.17 to 1.59) for past smokers in comparison with persons

who had never smoked. The multivariate RR of psoriasis was 1.60 (95% CI, 1.31 to 1.97) for

those who had smoked 11 to 20 pack-years and 2.05 (95% CI, 1.66 to 2.53) for those who had

smoked 21 or more pack-years in comparison with nonsmokers. The multivariate RR of psoriasis

was 1.61 (95% CI, 1.30 to 2.00) for those who quit smoking less than 10 years ago, 1.31 (95% CI,

1.05 to 1.64) for those who had quit 10 to 19 years ago, and 1.15 (95% CI, 0.88 to 1.51) for those

who had quit 20 or more years ago in comparison with persons who had never smoked. An

increased risk of psoriasis was associated with prenatal and childhood exposure to passive smoke.

Conclusions: The prospective analysis suggests that current and past smoking, and cumulative

measures of smoking, were associated with the incidence of psoriasis. After 20 years of smoking

cessation, the risk of the incident psoriasis among ex-smokers decreases nearly to that of persons

who have never smoked.”

Setty et al., 2007, p. 953

Retrospective Cohort Studies A retrospective cohort study is an epidemiological study in which the researcher identifies a group

of people who have experienced a particular event. This is a common research technique used in

the field of epidemiology to study occupational exposure to chemicals. Events of interest to nursing

that could be studied in this manner include a procedure, episode of care, nursing intervention, or

diagnosis. Nurses might use a retrospective cohort study to follow a cohort of women who had

undergone mastectomy for breast cancer or of patients in whom a urinary bladder catheter was

placed during and after surgery. The cohort is evaluated after the event to determine the occurrence

of changes in health status, usually the development of a particular disease or death. Nurses might

be interested in the pattern of recovery after an event or, in the case of catheterization, the incidence

of bladder infections in the months after surgery.

On the basis of the study findings, epidemiologists calculate the relative risk of the identified

change in health for the group. Relative risk is the probability of the outcome occurring in the

exposed group versus that in the nonexposed group. For example, if death were the occurrence

of interest, the expected number of deaths would be determined. The observed number of deaths

485CHAPTER 14 Outcomes Research

divided by the expected number of deaths and multiplied by 100 yields a standardized mortality

ratio (SMR), which is regarded as a measure of the relative risk of the studied group to die of a

particular condition. In nursing studies, patients might be followed over time after discharge from

a healthcare facility to determine complication rates and the SMR (Swaen & Meijers, 1988).

In retrospective studies, researchers commonly ask patients to recall information relevant to

their previous health status. This information is often used to determine the amount of change

occurring before and after an intervention. Recall can easily be distorted, thereby misleading

researchers in determining outcomes. Therefore, recall should be used with caution. Herrmann

(1995) identified three sources of distortion in recall: (1) the question posed to the subject may

be conceived or expressed incorrectly; (2) the recall process may be in error; and (3) the research

design used to measure recall may result in the recall’s appearing to be different from what actually

occurred. Herrmann (1995, p. AS90) also identified four bases of recall:

Direct recall: The subject “accesses the memory without having to think or search memory,” result-

ing in correct information.

Indirect recall: The subject “accesses the memory after thinking or searching memory,” resulting in

correct information.

Limited recall: “Access to the memory does not occur but information that suggests the contents of

the memory is accessed,” resulting in an educated guess.

No recall: “Neither the memory nor information relevant to the memory may be accessed,” result-

ing in a wild guess.

The following abstract, developed by Doran and associates (2013), in their study of adverse

events and outcomes in the Canadian home care population, is presented as an example of a ret-

rospective cohort study. It is also an example of a study that used large secondary databases as data

sources.

“Background: Home care (HC) is a critical component of the ongoing restructuring of health

care in Canada. It impacts three dimensions of healthcare delivery: primary health care, chronic

disease management, and aging at home strategies. The purpose of our study is to investigate a

significant safety dimension of HC, the occurrence of adverse events and their related outcomes.

The study reports on the incidence of HC adverse events, the magnitude of the events, the types of

events that occur, and the consequences experienced by HC clients in the province of Ontario.

Methods: A retrospective cohort design was used, utilizing comprehensive secondary databases

available for Ontario HC clients from the years 2008 and 2009. The data were derived from the

Canadian Home Care Reporting System, the Hospital Discharge Abstract Database, the

National Ambulatory Care Reporting System, the Ontario Mental Health Reporting System,

and the Continuing Care Reporting System. Descriptive analysis was used to identify the type

and frequency of the adverse events recorded and the consequences of the events. Logistic regres-

sion analysis was used to examine the association between the events and their consequences.

Results: The study found that the incident rate for adverse events for the HC clients included in

the cohort was 13%. The most frequent adverse events identified in the databases were injurious

falls, injuries from other than a fall, and medication-related incidents. With respect to outcomes,

we determined that an injurious fall was associated with a significant increase in the odds of a

client requiring long-term-care facility admission and of client death. We further determined

that three types of events, delirium, sepsis, and medication-related incidents were associated

directly with an increase in the odds of client death.

Conclusions: Our study concludes that 13% of clients in home care experience an adverse

event annually. We also determined that an injurious fall was the most frequent of the adverse

486 CHAPTER 14 Outcomes Research

events and was associated with increased admission to long-term care or death. We recommend

the use of tools that are presently available in Canada, such as the Resident Assessment Instru-

ment and its Clinical Assessment Protocols, for assessing and mitigating the risk of an adverse

event occurring.”

Doran et al., 2013, p. 227

Population-Based Studies Population-based studies are conducted within the context of the patient’s community rather

than the context of the medical system. With this method, all cases of a condition occurring in

the defined population are included, not just the cases treated at a particular healthcare facility.

The latter could introduce a selection bias. The researcher might make efforts to include individ-

uals with the condition who had not received treatment.

Community-based norms of tests and survey instruments obtained in this manner provide

a clearer picture of the range of values than the limited spectrum of patients seen in specialty

clinics. Estimates of instrument sensitivity and specificity are more accurate (see Chapter 10).

This method enables researchers to understand the natural history of a condition or the long-

term risks and benefits of a particular intervention (Guess et al., 1995). Bakker and co-workers

(2011) conducted a study examining the differences in birth outcomes related to maternal age.

The following is an abstract of their study:

“Background: Previous studies have shown that birth weight and preterm birth are strong pre-

dictors of neonatal morbidity and mortality. Maternal age might be a modifiable determinant of

weight and gestational age at birth. In most Western countries, the age of mothers having their

first child is increasing due to prolonged education, professional commitment, delayed marriage,

and other personal reasons. It has been suggested that older maternal age is associated with

increased risks of pregnancy complications, such as gestational hypertension or diabetes, preterm

delivery, fetal malformations, and fetal death.

Methods: This is a population-based prospective cohort study with 8,568 mothers and their

children based in Rotterdam, Netherlands. Maternal age, sociodemographic, lifestyle-related

determinants, and birth outcomes were obtained from questionnaires and hospital records.

The main outcome measures were birth weight, preterm delivery, small-for-gestational-age,

and large-for-gestational-age babies. Multivariate linear and logistic regression analyses were

used to analyze study data.

Results: In this study, mothers aged 30-34.9 years had no differences in risk of preterm delivery.

Mothers <20 years had the highest risk of delivering small-for-gestational-age babies (OR 1.6, 95% CI: 1.1-2.5); however, after adjustment for sociodemographic and lifestyle-related determi-

nants this increased risk was not present. Mothers >40 years had the highest risk of delivering large-for-gestational-age babies (OR 1.3, 95% CI: 0.8-2.4); however no associations of maternal

age with the risks of delivering large-for-gestational-age babies could be explained by sociode-

mographic and lifestyle-related determinants.

Conclusions: Younger mothers have an increased risk of small-for-gestational age babies,

whereas older mothers have an increased risk of large-for-gestational-age babies when compared

with mothers aged 30-34.9 years. Sociodemographic and lifestyle-related determinants cannot

entirely explain these differences.”

Bakker et al., 2011, p. 500

487CHAPTER 14 Outcomes Research

Economic Studies

Many of the problems studied in outcomes research address concerns related to the efficient use of

scarce resources and thus to economics. Health economists are concerned with the costs and ben-

efits of alternative treatments or ways of identifying the most efficient means of care. Economic

evaluation has been defined as a “set of formal, quantitative methods used to compare two or more

treatments, programs, or strategies with respect to their resource use and their expected outcomes”

(Guyatt, Rennie, Meade, & Cook, 2008, p. 781). An economist defines efficiency as the least expen-

sive method of achieving a desired end while obtaining the maximum benefit, or outcome, from

available resources. If available resources must be shared with other programs or other types of

patients, an economic study can determine whether changing the distribution of resources will

increase total benefit or welfare.

Ethical Studies

Outcomes studies often lead to policies for allocating scarce resources. Ethicists take the position

that a moral principle, justice for example, can constrain the use of costs and benefits to choose

treatments that might maximize the benefit per unit cost. Value commitments are inherent in

choices about research methods and about the selection and interpretation of outcome variables,

and researchers should acknowledge these commitments. “The choices researchers make should be

documented and the reasons for those choices should be given explicitly in publications and pre-

sentations so that readers and other users of the information are enabled and expected to bear

more responsibility for interpreting and applying the findings appropriately” (Lynn & Virnig,

1995, p. AS292). Veatch (1993) proposed that by analyzing the implications of rationing decisions

in terms of the principles of justice and autonomy, we would establish more acceptable criteria

than by using outcomes predictors alone. Veatch performed an ethical analysis of the use of out-

come predictors in decisions related to the early withdrawal of life support. We know that ethical

studies must play an important role in outcome programs of research.

In ethics-related research in Israel, DeKeyser Ganz, and Berkovitz (2012) investigated surgical

nurses’ perceptions of ethical dilemmas, moral distress, and quality of care. They found that per-

ceived quality of care was related to ethical dilemmas and moral distress among surgical nurses. More

specifically, nurses tended to be satisfied with their level of quality of care; however, as they reported

more ethical dilemmas, they also perceived more problems with some aspects of the quality of care.

Measurement Methods The selection of appropriate outcome variables is critical to the success of an outcomes research

study. As in any study, the researcher must evaluate the evidence of validity and reliability of the

measurement methods (see Chapter 10). Outcomes selected for nursing studies should be those

most consistent with nursing practice and theory (Doran, 2011). In some studies, rather than

selecting the final outcome of care, which may not occur for months or years, researchers use mea-

sures of intermediate end points or proximal outcomes. Intermediate end points are events or

markers that act as precursors to the final outcome. It is important, however, to document the

validity of the intermediate end point in predicting the outcome (Freedman & Schatzkin,

1992). In early outcomes studies, researchers selected outcome measures that they could easily

obtain, rather than those most desirable for an outcomes study. Later outcome studies selected

outcome measures from secondary data sources (e.g., Aiken et al., 2008; Cummings, Midodzi,

Wong, & Estabrooks, 2010). This selection involves secondary analysis, which is “any reanalysis

of data or information collected by another researcher or organization, including analysis of data

sets collected from a variety of sources to create time-series or area-based data sets” (Shi, 2008,

488 CHAPTER 14 Outcomes Research

p. 129). Outcomes researchers have used secondary data from sources such as hospital discharge

data (Aiken et al., 2008; Cummings et al., 2010). Data collected through NDNQI (2013) or

CALNOC (2013b) can also be used in nursing outcomes research.

Table 14-7 identifies characteristics that must be evaluated when selecting methods of measur-

ing outcomes. In evaluating a particular outcome measure, the researcher should consult the lit-

erature for previous studies that used that particular method of measurement, including the

publication that describes the development of the method of measurement. This approach was

TABLE 14-7 CHARACTERISTICS OF OUTCOMES ASSESSMENT INSTRUMENTS*

CHARACTERISTIC

CONSIDERATIONS IN PATIENT

OUTCOMES EVALUATION REFERENCES

Applicability • Consider purpose of instruments.

• Discriminate between subjects at a point

in time.

• Predict future outcomes.

• Evaluate changes within subjects over

time.

• Screen for problems.

• Provide case mix adjustment.

• Assess quality of care.

• Consider whether norms are established

for clinical population of interest.

• Instrument format is compatible with

assessment approach (e.g., observer-rated

versus self-administered).

• Setting in which instrument was

developed.

Deyo, 1984; Deyo & Carter, 1992;

Deyo et al., 1994; Feinstein et al.,

1986; Guyatt et al., 1987; Stewart

et al., 1989

Practicality (clinical

utility)

The instrument:

• Includes outcomes important to the patient.

• Is short and easy to administer (low

respondent burden); includes questions

that are easy to understand and acceptable

to patients and interviewers.

• Has scores that reflect condition severity

and condition-specific features and

discriminate those with conditions from

those without.

• Is easily scored and has readily

understandable scores.

• Uses a level of measurement that allows a

change score to be determined.

• Provides information that is clinically useful.

• Is performance- or capacity-based.

• Includes patient rating of magnitude of

effort and support needed for performance

of physical tasks.

Bombardier & Tugwell, 1987; Deyo,

1984; Deyo et al., 1994; Feinstein

et al., 1986; Kirshner & Guyatt, 1985;

Leidy, 1991; Lohr, 1988; Nelson

et al., 1990; Stewart et al., 1989

Continued

489CHAPTER 14 Outcomes Research

TABLE 14-7 CHARACTERISTICS OF OUTCOMES ASSESSMENT INSTRUMENTS—cont’d

CHARACTERISTIC

CONSIDERATIONS IN PATIENT

OUTCOMES EVALUATION REFERENCES

Comprehensiveness • Generic measures are designed to

summarize a spectrum of concepts applied

to different impairments, illnesses,

patients, and populations.

• Disease-specific measures are designed to

assess specific patients with specific

conditions or diagnoses.

• Dimensions of the instrument—a core set

of physical, mental, and role functions is

desirable.

Deyo, 1984; Deyo et al., 1994; Nelson

et al., 1990; Patrick & Deyo, 1989

Reliability • Can be influenced by:

• Day to day variations in patients,

• Differences between observers, and

• Items in the scale, mode of

administration.

• Is the critical determinant of usefulness of

an instrument.

• Is designed for discriminative purposes.

Deyo, 1984; Deyo et al., 1994; Guyatt

et al., 1987; Nelson et al., 1990

Validity • No consensus of what are scientifically

admissible criteria for many indices.

• No gold standard for establishing criterion

validity for many indices.

Deyo, 1984; Deyo et al., 1994; Spitzer,

1987

Responsiveness • Is not yet indexed for almost any evaluative

measures.

• A coarse scale rating may not detect

changes.

• Aggregated scores may obscure changes in

subscales.

• Is useful for determining sample size and

statistical power.

• Reliable instruments are likely to be

responsive, but reliability not adequate as

sole index of consistent results over time.

• Detail in scaling should be considered.

• As baseline variability of score changes

within stable subjects, larger treatment

effects may be needed to demonstrate

efficacy.

• The temporal relationship between

intervention and outcome should be

considered.

Bombardier & Tugwell, 1987; Deyo,

1984; Deyo & Centor, 1986; Guyatt

et al., 1987; Jaeschke et al., 1989;

Leidy, 1991; Stewart & Archbold,

1992

*Examples are illustrative; for a complete list of structural, process, and outcome indicators, refer to the original

sources cited in the table.

Modified from Harris M. R., & Warren, J. J. (1995). Patient outcomes: Assessment issues for the CNS. Clinical Nurse

Specialist, 9(2), 82.

490 CHAPTER 14 Outcomes Research

used by Doran and colleagues (2011) when they reviewed the state of the science on nursing-

sensitive outcomes. For each outcome concept (e.g., functional status, pain, pressure ulcer,

self-care), the empirical literature investigating the concept in nursing research was reviewed.

The approach to measurement of the outcome concept was identified, and the reliability, sensi-

tivity, and validity of the measurement tools were appraised and summarized in tabular form. Sen-

sitivity to change is an important measurement property to consider in outcomes research because

researchers are often interested in evaluating how outcomes change in response to healthcare inter-

ventions. As the sensitivity of a measure increases, statistical power increases, allowing smaller

sample sizes to detect significant differences. For a full discussion of the reliability and validity

of scales and questionnaires, precision and accuracy of physiological measures, and sensitivity

and specificity of diagnostic tools, see Chapter 10 of this text and Waltz and associates’ (2010) text

on measurement in nursing and health research.

STATISTICAL METHODS FOR OUTCOMES STUDIES

Although outcomes researchers test for the statistical significance of their findings, that evaluation

is not considered sufficient to judge the findings as important. Their focus is the clinical impor-

tance of study findings (see Chapter 11 for more information on clinical importance). In analyzing

data, outcomes researchers have moved away from statistical analyses that use the mean to test for

group differences. They now place greater importance on analyzing change scores and use explor-

atory methods for examining the data to identify outliers.

Analysis of Change With the focus on outcomes studies has come a renewed interest in methods of analyzing change.

Gottman and Rushe (1993) reported that the first book addressing change in research, Problems in

Measuring Change, edited by Harris (1967), is the basis for most of the current approaches to ana-

lyzing change. However, some new ideas have emerged in recent years regarding the analysis of

change. Studies by Tracy and colleagues (2006) and Bettger, Coster, Latham, and Keysor (2008)

are good references in this regard.

For some outcomes, the changes may be nonlinear or may go up and down, rather than always

increasing. Therefore, it is as important to uncover patterns of change as it is to test for statistically

significant differences at various time points. Some changes may occur in relation to stages of

recovery or improvement. These changes may occur over weeks, months, or even years. A more

complete picture of the process of recovery is obtained by examining the process in greater detail

and over a broader range. With this approach, the examiner can develop a recovery curve, which

provides a model of the recovery process that can then be tested (Boz et al., 2004; Hernandez,

Fernandez, Luzon, Cuena, & Montejo, 2007; McCauley, Hannay, & Swank, 2001).

Analysis of Improvement In addition to reporting the mean improvement score for all patients treated, it is important to

report what percentage of patients improved. Did all patients improve slightly, or is there a diver-

gence among patients, with some improving greatly and others not improving at all? This diver-

gence may best be illustrated by plotting the data. Researchers studying a particular treatment or

approach to care might develop a standard or index of varying degrees of improvement that might

occur. The index would allow for better comparisons of the effectiveness of various treatments.

Characteristics of patients who experience varying degrees of improvement and outliers should

491CHAPTER 14 Outcomes Research

be described in the research report. This step requires that the study design include baseline mea-

sures of patient status, such as demographic characteristics, functional status, and disease severity

measures. An analysis of improvement allows for better judgments to be made about the appro-

priate use of various treatments (Fasting & Gisvold, 2003).

CRITICAL APPRAISAL OF OUTCOMES STUDIES

This section discusses approaches for critically appraising outcomes studies. Guyatt and colleagues

(2008) published the Users’ Guides to the Medical Literature, which outlines the methodology for

critically appraising study designs, including those typically used in outcomes research. This guide

provides worksheets used to summarize the results of a critical appraisal. The worksheets that are

most relevant to outcomes research are those that address studies of economic analysis, retrospec-

tive cohort design, health-related quality of life, and prospective cohort design. An example of the

types of questions to consider in critically appraising outcome studies of health-related quality of

life are provided in the following section.

Questions Guiding the Critical Appraisal of Outcomes Studies This section provides questions to assist you in critically appraising outcomes studies. These ques-

tions are organized by three broad questions: “Are the results valid?”, “What are the results?”, and

“How can I apply the results to patient care?”

Are the results valid?

• In a prospective cohort study, did the exposed and control groups start and finish with the same

risk of outcome?

• In nursing outcome studies, exposure could refer to a particular nursing intervention, staffing

model or staff mix, or even healthcare policy.

• Three subquestions need to be considered in addressing the original question about the validity

of the study results:

• Were patients similar for factors or variables known to be associated with the outcome (or

was statistical adjustment used to control for differences between the exposed and control

groups)?

• Were the circumstances and methods for detecting the outcome similar? Did the researchers

use the same method for measuring the outcome in the exposed and control groups?

• Was the follow-up sufficiently complete? Ideally, we would like to see approximately 80%

follow-up in both control and exposed groups.

In a retrospective cohort study, did the exposed and control groups have the same chance of

being exposed in the past? In a retrospective cohort study, the researcher would be interested

in determining whether outcomes differ for individuals exposed in the past to a particular health

risk, health condition, or health service by following individuals longitudinally after the particular

exposure. The following questions need to be addressed in retrospective cohort studies:

• Were cases and controls similar with respect to the indication or circumstances that would lead

to exposure? For example, were they all equally eligible to receive the particular nursing inter-

vention or receive care under the particular staffing model?

• Were the circumstances and methods for determining exposure similar for cases and controls?

In a retrospective cohort study, investigators look back in time to determine exposure to a par-

ticular intervention or determine the existence of a particular condition. To answer this ques-

tion, you would need to determine if the study used the same approach for determining

exposure in the control and intervention groups.

492 CHAPTER 14 Outcomes Research

What are the results?

• How strong is the association between exposure and outcome? Were the results statistically

significant?

• How precise was the estimate of effect? Were the confidence intervals for the effect large or

small? Small confidence intervals reflect greater precision in the estimate of effect.

In a study of an outcome such as health-related quality of life (HRQL): • Did the investigators measure aspects of patients’ lives that patients consider important? To

answer this question, you would need to consider whether the authors described the content

of their measure of health-related quality of life (HRQL) in sufficient detail so that it is possible

to make a judgment about the relevance of the measure for the particular patient population,

and/or whether the authors provided direct evidence from their study or indirect evidence from

previous studies that the HRQL measure is important to the patient population being

investigated.

• Did the HRQL instrument work in the intended way? This question requires an appraisal of the

psychometric properties of the HRQL instrument with regard to reliability and validity.

• Were important aspects of HRQL omitted from measurement? This question requires an

appraisal of the content validity of the instrument with regard to whether the instrument

was complete in its measurement of HRQL.

How can I apply the results to patient care? • Were the study patients similar to the patient in my practice setting?

• Was follow-up sufficiently long to assess an impact on outcome?

• Is the exposure (e.g., intervention, staffing model, healthcare policy) similar to what might

occur in my practice setting?

• What is the magnitude of effect? This question requires you to consider whether the effect was

clinically important to make it worthwhile to change practice?

• Are there any benefits that are known to be associated with exposure? This question asks you to

consider whether the benefits for patients and/or practice settings are sufficiently worthwhile to

suggest that you would want to act on the results.

Example Critical Appraisal of an Outcomes Study An example of a critical appraisal of a quality of life outcome study is provided below.

RESEARCH EXAMPLE

Critical Appraisal of an Outcomes Study

Research Study Excerpt Orwelius and colleagues (2013, p. 229) investigated long-term health-related quality of life (HRQoL or HRQL) after

burns. Their study abstract is as follows:

“Background: Health-related quality of life (HRQoL) is reduced after a burn, and is affected by coexisting con-

ditions. The aims of the investigation were to examine and describe effects of coexisting disease on HRQoL,

and to quantify the proportion of burned people whose HRQoL was below that of a reference group matched

for age, gender, and coexisting conditions.

Method: A nationwide study covering 9 years. . .examined HRQoL 12 and 24 months after the burn with

the SF-36 questionnaire. The reference group was from the referral area of one of the hospitals. Continued

493CHAPTER 14 Outcomes Research

K E Y C O N C E P T S

• Outcomes research examines the end results of patient care.

• The scientific approaches used in outcomes studies differ in some important ways from those

used in traditional research.

• Donabedian (1987, 2005) developed the theory on which outcomes research is based.

• Quality is the overriding construct of the theory, although Donabedian never defined this term.

• The three major concepts of the theory are health, subjects of care, and providers of care.

• Donabedian identified three objects of evaluation in appraising quality—structure, process, and

outcome.

RESEARCH EXAMPLE—cont’d

Results: The HRQoL of the burned patients was below that of the reference group mainly in the mental

dimensions, and only single patients were affected in the physical dimensions. The factor that significantly

affected most HRQoL dimensions (n¼6) after the burn was unemployment, whereas only smaller effects could be attributed directly to the burn.

Conclusion: Poor HRQoL was recorded for only a small number of patients, and the declines were

mostly in the mental dimensions when compared with a group adjusted for age, gender, and coexisting con-

ditions. Factors other than the burn itself, such as mainly unemployment and pre-existing disease, were most

important for the long-term HRQoL experience in these patients.”

Critical Appraisal The study used a retrospective cohort design. Individuals who experienced a burn were followed for 24 months to

determine the impact of the burn, along with other factors, on changes in HRQoL. The exposed group consisted of

all Swedish-speaking patients 18 years or older admitted with burns of 10% or more of total body surface area or

duration of stay in the burn unit of 7 days or more in 2000 to 2009 (hereafter referred to as the burn cohort). The

unexposed cohort was identified from a public health survey of one county in Sweden, which was completed in 1999

(hereafter referred to as the healthy reference cohort). The two cohorts were not similar for all factors known to be

associated with HRQoL. For example, the burn cohort had more males, fewer individuals with higher education,

more single individuals, and fewer individuals not employed or retired than the healthy reference cohort. These

differences could have influenced HRQoL and, in this study, the investigators accounted for the differences statis-

tically in their analysis. Although the circumstances for detecting the outcome were different for both cohorts, the

method of assessment—namely, the SF-36 (Ware & Sherbourne, 1992)—was the same. The SF-36 is a well-

recognized HRQoL measure, with high reliability and validity established in a representative Swedish population

and burn population (Edgar, Dawson, Hankey, Phillips, & Wood, 2010).

Follow-up in the burn cohort was 24 months, a duration that is considered sufficiently long for detecting change in

HRQoL. Of the eligible burn patients, 61% were recruited into the cohort and follow-up of these individuals at

24 months was 48%. Response after two reminders in the healthy reference cohort was 61%. Incomplete follow-

up of both cohorts could mean that there are systematic differences (i.e., response bias) between individuals

who responded to the survey from those who did not, thus influencing the generalizability of the study findings.

There were statistically significant differences in HRQoL between the burn and healthy reference cohorts, primarily

in the mental dimension, and the authors reported clinically significant improvements in physical function and role

function scores among the burn cohort. The factor that most significantly affected HRQoL after the burn was unem-

ployment, whereas only small effects could be attributed directly to the burn. In conclusion, there were some threats

to the validity of the study findings, particularly with regard to differences between the burn and healthy reference

cohorts and incomplete follow-up. Some of these differences were accounted for statistically in the analysis.

Strengths of the study included use of a reliable and valid measure of HRQoL and statistically and clinically signif-

icant effects. Translations of these findings to a North American population would depend on how similar the Swed-

ish population is to the North American population and how similar health care of burn patients is between them.

494 CHAPTER 14 Outcomes Research

• The goal of outcomes research is to evaluate outcomes as defined by Donabedian, whose theory

requires that identified outcomes be clearly linked with the process that caused the outcome.

• Clinical guideline panels are established to incorporate available evidence on health outcomes.

• Outcomes studies provide rich opportunities to build a stronger scientific underpinning for

nursing practice.

• A nursing-sensitive patient outcome is “sensitive” because it is influenced by nursing.

• Organizations currently involved in efforts to study nursing-sensitive outcomes include the

American Nurses Association, National Quality Forum, Collaborative Alliance for Nursing

Outcomes, Veterans Affairs Nursing Outcomes Database, Center for Medicare & Medicaid Ser-

vices Hospital Quality Initiative, American Hospital Association, Federation of American

Hospitals, The Joint Commission, and Agency of Healthcare Research and Quality.

• An area of interest is the process of care delivered by APNs (nurse practitioners, nurse midwives,

nurse anesthetists, and clinical nurse specialists).

• Outcome design strategies tend to have less control than traditional research designs discussed

in this text, except for randomized controlled trials (RCTs).

• Some of the common outcomes studies’ methodologies include prospective cohort studies, ret-

rospective cohort studies, population-based studies, economic analysis, and ethical studies.

• Outcomes studies generally use large representative, heterogeneous samples rather than

random samples.

• Statistical approaches used in outcomes studies include new approaches to examining measure-

ment reliability, strategies to analyze change, and the analysis of improvement.

• Dissemination is an important aspect of the outcomes research process because it ensures that

the study results will have an impact on patients, providers, and healthcare organizations.

• Critical appraisal of outcomes studies focuses on similarity of exposed and unexposed cohorts,

adequacy and completeness of follow-up, reliability and validity of the outcome measure(s),

and statistical and clinical significance of the study findings.

• An example critical appraisal of a current outcomes study is provided.

REFERENCES

Agency for Healthcare Research and Quality (AHRQ).

(2013). Outcomes research: Fact Sheet. Retrieved July 30,

2013 from, http://www.ahrq.gov/research/findings/

factsheets/outcomes/outfact/index.html.

Agency for Healthcare Research and Quality (AHRQ).

(2011). National Guideline Clearinghouse. Retrieved

July 30, 2013 from, http://www.guideline.gov.

Agency for Healthcare Research and Quality (AHRQ).

(2010). HHS awards $437 million in patient-centered

outcomes research funding. Retrieved July 30, 2013

from, http://www.ahrq.gov/health-care-information/

topics/topic-arra.html.

Aiken, L. H., Clarke, S. P., Sloane, D. M., Lake, E. T., &

Cheney, T. (2008). Effects of hospital care environment

on patient mortality and nurse outcomes. Journal of

Nursing Administration, 38(5), 223–229.

Bakker, R., Steegers, E., Biharie, A., Mackenbach, J.,

Hofman, A., & Jaddoe, V. (2011). Explaining

differences in birth outcomes in relation to maternal

age: The Generation R Study. BJOG: An International

Journal of Obstetrics and Gynaecology, 118(4),

500–509.

Bettger, J. A., Coster, W. J., Latham, N. K., & Keysor, J. J.

(2008). Analyzing change in recovery patterns in the

year after acute hospitalization. Archives of Physical

Medicine & Rehabilitation, 89(7), 1267–1275.

Bombardier, C., & Tugwell, P. (1987). Methodological

considerations in functional assessment. Journal of

Rheumatology, 14(Suppl. 15), 7–10.

Boz, C., Ozmenoglu, M., Alioglu, Z., Velioglu, S.,

Altunayoglu, V., & Gazioglu, S. (2004). Local cold effect

on the excitability recovery curve of the sympathetic

skin response. Electromyography & Clinical

Neurophysiology, 44(8), 497–501.

Brenner, M. H., Curbow, B., & Legro, M. W. (1995). The

proximal-distal continuum of multiple health outcome

495CHAPTER 14 Outcomes Research

measures: The case of cataract surgery. Medical Care, 33

(4 Suppl.), AS236–AS244.

Canadian Institute for Health Information (CIHI).

(2012). Frequently asked questions about the MIS

Standards. Retrieved July 30, 2013 from, http://www.

cihi.ca/cihi-ext-portal/internet/en/document/

standards+and+data+submission/standards/mis

+standards/mis_faq.

Clancy, C. M., & Eisenberg, J. M. (1998). Outcomes

research: Measuring the end results of health care.

Science, 282(5387), 245–246.

Clarke, S. P. (2011). Health care utilization. In D. M. Doran

(Ed.), Nursing outcomes: The state of the science

(pp. 439–485) (2nd ed.). Sudbury, MA: Jones & Bartlett.

Collaborative Alliance for Nursing Outcomes (CALNOC).

(2013a). Home page. Retrieved July 30, 2013 from,

http://calnoc.org.

Collaborative Alliance for Nursing Outcomes (CALNOC).

(2013b). Overview. Retrieved July 30, 2013 from, http://

www.calnoc.org/displaycommon.cfm?an¼1. Cummings, G. G., Midodzi, W. K., Wong, C. A., &

Estabrooks, C. A. (2010). The contribution of hospital

nursing leadership styles to 30-day patient mortality.

Nursing Research, 59(5), 331–339.

Davies, B., Edwards, N., Ploeg, J., & Virani, T. (2008).

Insights about the process and impact of implementing

nursing guidelines on delivery of care in hospitals

and community settings. BMC Health Services

Research, 8, 29.

DeKeyser Ganz, F., & Berkovitz, K. (2012). Surgical nurses’

perceptions of ethical dilemmas, moral distress and

quality of care. Journal of Advanced Nursing, 68(7),

1516–1525.

Deyo, R. A. (1984). Measuring functional outcomes in

therapeutic trials for chronic disease. Controlled

Clinical Trials, 5(3), 223–240.

Deyo, R. A., & Carter, W. B. (1992). Strategies for

improving and expanding the application of health

status measures in clinical settings. Medical Care, 30

(Suppl.), MS176–MS186.

Deyo, R. A., & Centor, R. M. (1986). Assessing the

responsiveness of functional scales to clinical change:

An analogy to diagnostic test performance. Journal of

Chronic Disease, 39(11), 897–906.

Deyo, R. A., Taylor, V. M., Diehr, P., Conrad, D.,

Cherkin, D. C., Ciol, M., et al. (1994). Analysis of

automated administrative and survey databases to

study patterns and outcomes of care. Spine, 19(18),

2083S–2091S.

DiCenso, A., Martin-Misener, R., Bryant-Lukosius, D.,

Bourgeault, I., Kilpatrick, K., Donald, F., et al. (2010).

Advanced practice nursing in Canada: Overview of a

decision support synthesis. Canadian Journal of

Nursing Leadership, 23(special issue), 15–34.

Donabedian, A. (1976). Benefits in medical care programs.

Cambridge, MA: Harvard University Press.

Donabedian, A. (1978). Needed research in quality

assessment and monitoring. Hyattsville, MD: U.S.

Department of Health, Education, and Welfare, Public

Health Service, National Center for Health Services

Research.

Donabedian, A. (1980). Explorations in quality assessment

and monitoring. Ann Arbor, MI: Health Administration

Press.

Donabedian, A. (1982). The criteria and standards of

quality. Ann Arbor, MI: Health Administration Press.

Donabedian, A. (1987). Some basic issues in evaluating the

quality of health care. In L. T. Rinke (Ed.), Outcome

measures in home care: Vol. I. (p. 338). New York:

National League for Nursing (Original work published

in 1976.).

Donabedian, A. (1988). The quality of care: How can it be

assessed? Journal of the American Medical Association,

260(12), 1743–1748.

Donabedian, A. (2005). Evaluating the quality of medical

care. The Milbank Quarterly, 83(4), 691–729.

Doran, D. M. (Ed.). (2011). Nursing outcomes: The state of

the science. (2nd ed.). Sudbury, MA: Jones & Bartlett.

Doran, D. M., Harrison, M., Laschinger, H. S., Hirdes, J.,

Rukholm, E., Sidani, S., et al. (2006a). Nursing sensitive

outcomes data collection in acute care and long-term

care settings. Nursing Research, 55(2S), S75–S81.

Doran, D., Harrison, M. B., Laschinger, H., Hirdes, J.,

Rukholm, E., Sidani, S., et al. (2006b). Relationship

between nursing interventions and outcome

achievement in acute care settings. Research in Nursing

& Health, 29(1), 61–70.

Doran, D. M., Mildon, B., & Clarke, S. (2011). Toward a

national report card in nursing: A knowledge synthesis.

Canadian Journal of Nursing Leadership, 24(2), 38–57.

Doran, D. M., Regis, B., Hirdes, J. P., Baker, G. R., Poss, J.

W., Li, X., et al. (2013). Adverse outcomes among home

care clients associated with emergency room visit or

pre-hospitalization: A descriptive study of secondary

health databases. BMC Health Services Research, 13,

227.

Doran, D. M., Sidani, S., & Di Pietro, T. (2010).

Nursing-sensitive outcomes. In J. S. Fulton, B. Lyon, &

K. Goudreau (Eds.), Foundations of clinical nurse

specialist practices (pp. 35–37). New York: Springer.

Doran, D. M., Sidani, S., Keatings, M., & Doidge, D.

(2002). An empirical test of the Nursing Role

496 CHAPTER 14 Outcomes Research

Effectiveness Model. Journal of Advanced Nursing,

38(1), 29–39.

Edgar, D., Dawson, A., Hankey, G., Phillips, M., &

Wood, F. (2010). Demonstration of the validity of the

SF-36 for measurement of the temporal recovery of

quality of life outcomes in burns survivors. Burns,

36(7), 1013–1020.

Fasting, S., & Gisvold, S. E. (2003). Statistical process

control methods allow the analysis and improvement

of anesthesia care. Canadian Journal of Anesthesia,

50(8), 767–774.

Feinstein, A. R., Josephy, B. R., & Wells, C. K. (1986).

Scientific and clinical problems in indexes of functional

disability. Annals of Internal Medicine, 105(3), 413–420.

Freedman, L. S., & Schatzkin, A. (1992). Sample size for

studying intermediate endpoints within intervention

trials or observational studies. American Journal of

Epidemiology, 136(9), 1148–1159.

Gottman, J. M., & Rushe, R. H. (1993). The analysis of

change: Issues, fallacies, and new ideas. Journal of

Consulting and Clinical Psychology, 61(6), 907–910.

Graham, I. D., Bick, D., Tetroe, J., Straus, S. E., &

Harrison, M. B. (2011). Measuring outcomes of

evidence-based practice: Distinguishing between

knowledge use and its impact. In D. Bick, & I. Graham

(Eds.), Evaluating the impact of implementing evidence-

based practice (pp. 18–37). Oxford, United Kingdom:

Wiley-Blackwell.

Grove, S. K., Burns, N., & Gray, J. R. (2013). The practice of

nursing research: Appraisal, synthesis, and generation

of evidence (7th ed.). Philadelphia: Elsevier Saunders.

Guess, H. A., Jacobsen, S. J., Girman, C. J., Oesterling, J. E.,

Chute, C. G., Panser, L. A., et al. (1995). The role of

community-based longitudinal studies in evaluating

treatment effects. Example: Benign prostatic

hyperplasia. Medical Care, 33(Suppl. 4), AS26–AS35.

Guyatt, G., Rennie, D., Meade, M. O., & Cook, D. J. (2008).

Users’ guides to the medical literature: A manual for

evidence-based practice (2nd ed.). New York, NY:

McGraw-Hill Medical.

Guyatt, G., Walter, S., & Norman, G. (1987). Measuring

change over time: Assessing the usefulness of evaluative

instruments. Journal of Chronic Disease, 40(2),

171–178.

Harris, C. W. (1967). Problems in measuring change.

Madison, WI: University of Wisconsin Press.

Harris, M. R., & Warren, J. J. (1995). Patient outcomes:

Assessment issues for the CNS. Clinical Nurse

Specialist, 9(2), 82–86.

Hernandez, G., Fernandez, R., Luzon, E., Cuena, R., &

Montejo, J. C. (2007). The early phase of the minute

ventilation recovery curve predicts extubation failure

better than the minute ventilation recovery time. Chest,

131(5), 1315–1322.

Herrmann, D. (1995). Reporting current, past, and

changed health status: What we know about distortion.

Medical Care, 33(Suppl. 4), AS89–AS94.

Howell, D. (2011). Psychological distress as a nurse-

sensitive outcome. In D. M. Doran (Ed.), Nursing

outcomes: The state of the science (pp. 285–358)

(2nd ed.). Sudbury, MA: Jones & Bartlett.

Irvine, D. M., Sidani, S., & McGillis Hall, L. (1998).

Linking outcomes to nurses’ roles in health care.

Nursing Economic$, 16(2), 58–64, 87.

Jaeschke, R., Singer, J., & Guyatt, G. H. (1989).

Measurement of health status: Ascertaining the

minimal clinically important difference. Controlled

Clinical Trials, 10(4), 407–415.

Jefford, M., Stockler, M. R., & Tattersall, M. H. N. (2003).

Outcomes research: What is it and why does it matter?

Internal Medicine Journal, 33(3), 110–118.

Jenerette, C. M., & Murdaugh, C. (2008). Testing the

theory of self-care management for sickle cell disease.

Research in Nursing & Health, 31(4), 355–369.

Kirshner, B., & Guyatt, G. (1985). A methodological

framework for assessing health indices. Journal of

Chronic Diseases, 38(1), 27–36.

Kleib, M., Sales, A., Doran, D. M., Malette, C., & White, D.

(2011). Nursing minimum data sets. In D. M. Doran

(Ed.), Nursing outcomes: The state of the science

(pp. 487–512) (2nd ed.). Sudbury, MA: Jones &

Bartlett.

Knight, M. M. (2000). Cognitive ability and functional

status. Journal of Advanced Nursing, 31(6), 1459–1468.

Kramer, M., Maguire, P., & Schmalenberg, C. (2006).

Excellence through evidence: The what, when, and

where of clinical autonomy. Journal of Nursing

Administration, 36(10), 479–491.

Kutney-Lee, A., Sloane, D., & Aiken, L. (2013). Increase in

the number of nurses with baccalaureate degrees is

linked to lower rates of postsurgery mortality. Health

Affairs, 32(3), 579–586.

Lake, E. T. (2006). Multilevel models in health outcomes

research. Part I: Theory, design, and measurement.

Applied Nursing Research, 19(1), 51–53.

Lee, T. H., & Goldman, L. (1989). Development and

analysis of observational data bases. Journal of the

American College of Cardiology, 14(Suppl. 3A),

44A–47A.

Leidy, N. K. (1991). Survey measures of functional ability

and disability of pulmonary patients. In B. L. Metzger

(Ed.), Synthesis conference on altered functioning:

497CHAPTER 14 Outcomes Research

Impairment and disability (pp. 52–79). Indianapolis:

Nursing Center Press of Sigma Theta Tau International.

Loegering, L., Reiter, R. C., & Gambone, J. C. (1994).

Measuring the quality of health care. Clinical Obstetrics

and Gynecology, 37(1), 122–136.

Lohr, K. N. (1988). Outcome measurement: Concepts and

questions. Inquiry, 25(1), 37–50.

Lynn, J., & Virnig, B. A. (1995). Assessing the significance

of treatment effects: Comments from the perspective of

ethics. Medical Care, 33(4), AS292–AS298.

Magnello, M. E. (2010). The passionate statistician. In

S. Nelson, & A. M. Rafferty (Eds.), Notes On

Nightingale: The influence and legacy of a nursing icon

(pp. 115–129). Ithaca, NY: Cornell University Press.

Mark, B. A. (1995). The black box of patient outcomes

research. Image: Journal of Nursing Scholarship, 27(1),

42.

McCauley, S. R., Hannay, H. J., & Swank, P. R. (2001).

Use of the disability rating scale recovery curve as a

predictor of psychosocial outcome following

closed-headed injury. Journal of the International

Neuropsychology Society, 7(4), 457–467.

McDonald, C. J., & Hui, S. L. (1991). The analysis of

humongous databases: Problems and promises.

Statistics in Medicine, 10(4), 511–518.

McGillis Hall, L., Doran, D., Baker, G. R., Pink, G. H.,

Sidani, S., O’Brien-Pallas, L., et al. (2003). Nurse

staffing models as predictors of patient outcomes.

Medical Care, 41(9), 1096–1109.

Merskey, H., & Bogduk, N. (1994). Classification of chronic

pain: Descriptions of chronic pain syndromes and

definitions of pain terms (2nd ed.). Seattle: IASP Press.

Mitchell, J. B., Bubolz, T., Pail, J. E., Pashos, C. L.,

Escarce, J. J., Muhlbaier, L. H., et al. (1994). Using

Medicare claims for outcomes research. Medical Care,

32(Suppl. 7), JS38–JS51.

Mitchell, P. H., Ferketich, S., & Jennings, B. M. (1998).

American Academy of Nursing Expert Panel on Quality

Health Care: 1998 Quality Health Outcomes Model.

Image—Journal of Nursing Scholarship, 30(1), 43–46.

Montalvo, I. (2007). National Database of Nursing Quality

Indicators (NDNQI). Retrieved July 30, 2013 from,

http://www.nursingworld.org/ojin.

Moore, J., & McQuestion, M. (2012). The clinical nurse

specialist in chronic diseases. Clinical Nurse Specialist,

26(3), 149–163.

Moses, L. E. (1995). Measuring effects without

randomized trials? Options, problems, challenges.

Medical Care, 33(4), AS8–AS14.

National Database of Nursing Quality Indicators

(NDNQI). (2013). ANA’s NQF-endorsed measure

specifications: Guidelines for data collection on the

American Nurses Association’s national quality forum

endorsed measures: Nursing care hours per patient day;

skill mix; falls and falls with injury. Retrieved July 30,

2013 from home page link at, http://www.

nursingquality.org/FAQs.

National Quality Forum (NQF). (2013a). About NQF.

Retrieved July 30, 2013 from, http://www.

qualityforum.org/Measures_Reports_Tools.aspx.

National Quality Forum (NQF). (2013b). National

standards to evaluate health care quality based on how

patients feel. Retrieved July 30, 2013 from, http://www.

qualityforum.org/News_And_Resources/Press_

Releases/2013/National_Standards_to_Evaluate_

Health_Care_Quality_Based_On_How_Patients_Feel.

aspx.

Nelson, E. C., Landgraf, J. M., Hays, R. D., Wasson, J. H., &

Kirk, J. W. (1990). The functional status of patients:

How can it be measured in physicians’ offices? Medical

Care, 28(12), 1111–1126.

Oh, S. H., Park, E. J., Yin, Y., Piao, J., & Lee, S. (2013).

Automatic delirium prediction system in Korean

surgical intensive care unit. Nursing in Critical Care.

http://dx.doi.org/10.1111/nicc.12048, Electronic

publication ahead of print October 24, 2013.

Oncology Nursing Society (ONS). (2012). About the ONS.

Retrieved July 30, 2013 from, http://www.ons.org/

about.

Orem, D. (2001). Nursing concepts of practice (6th ed.).

St Louis: Mosby.

Orwelius, L., Willebrand, M., Gerdin, L., Ekselius, L.,

Fredrikson, M., & Sjöberg, F. (2013). Long-term health-

related quality of life after burns is stronglydependent on

pre-existing disease and psychosocial issues and less due

to the burn itself. Burns, 39(2), 229–235.

Patrick, D. L., & Deyo, R. A. (1989). Generic and disease-

specific measures in assessing health status and quality

of life. Medical Care, 27(Suppl. 3), S217–S232.

Sermeus, W., Delesie, L., Van den Heede, K., Diya, L., &

Lesaffre, E. (2008). Measuring the intensity of nursing

care: Making use of the Belgian nursing minimum data

set. International Journal of Nursing Studies, 45(7),

1011–1021.

Setty, A. R., Curhan, G., & Choi, H. K. (2007). Smoking and

the risk of psoriasis in women: Nurses’ Health Study II.

American Journal of Medicine, 120(11), 953–959.

Shi, L. (2008). Health services research methods (2nd ed.).

Clifton Park, NY: Delmar Cengage Learning.

Sidani, S. (2011a). Self-care. In D. M. Doran (Ed.), Nursing

outcomes: The state of the science (pp. 79–130) (2nd

ed.). Sudbury, MA: Jones & Bartlett.

498 CHAPTER 14 Outcomes Research

Sidani, S. (2011b). Symptom management. In D. M. Doran

(Ed.), Nursing outcomes: The state of the science

(pp. 131–199) (2nd ed.). Sudbury, MA: Jones & Bartlett.

Spence Laschinger, H., Gilbert, S., & Smith, L. (2011).

Patient satisfaction as a nurse-sensitive outcome. In D.

M. Doran (Ed.), Nursing outcomes: The state of the

science (pp. 359–408) (2nd ed.). Sudbury, MA: Jones &

Bartlett.

Spitzer, W. O. (1987). State of science 1986: Quality of life

and functional status as target variables for research.

Journal of Chronic Disease, 40(6), 465–471.

Stetler, C. B., & Caramanica, B. (2007). Evaluation of an

evidence-based practice initiative: Outcomes,

strengths, and limitations of a retrospective

conceptually based approach. Worldviews on

Evidence-Based Nursing, 4(4), 187–199.

Stewart, A. L., Greenfield, S., Hays, R. D., Wells, K.,

Rogers, W. H., Berry, S. D., et al. (1989). Functional

status and well-being of patients with chronic

conditions. Journal of the American Medical

Association, 262(7), 907–913.

Stewart, B. J., & Archbold, P. G. (1992). Nursing

intervention studies require outcome measures that are

sensitive to change: Part 2. Research in Nursing &

Health, 16(1), 77–81.

Stone, P. W., Mooney-Kane, C., Larson, E. L., Horan, T.,

Glance, L. G., Zwanziger, J., et al. (2007). Nurse

working conditions and patient safety outcomes.

Medical Care, 45(6), 571–578.

Swaen, G. M., & Meijers, J. M. (1988). Influence of design

characteristics on the outcomes of retrospective cohort

studies. British Journal of Industrial Medicine, 45(9),

624–629.

Tourangeau, A. E. (2011). Mortality rate: A nursing

sensitive outcome. In D. M. Doran (Ed.), Nursing

outcomes: The state of the science (pp. 409–437). (2nd

ed.). Sudbury, MA: Jones & Bartlett.

Tourangeau, A. E., Doran, D. M., Hall, L. M., O’Brien

Pallas, L., Pringle, D., Tu, J. V., et al. (2007). Impact of

hospital nursing care on 30-day mortality for acute

medical patients. Journal of Advanced Nursing, 57(1),

32–44.

Tourangeau, A. E. (2003). Modeling the determinants of

mortality for hospitalized patients. International

Nursing Perspectives, 3(1), 37–48.

Tracy, S., Schinco, M. A., Griffen, M. M., Kerwin, A. J.,

Devin, T., & Tepas, J. J. (2006). Urgent airway

intervention: Does outcome change with personnel

performing the procedure? Journal of Trauma, 61(5),

1162–1165.

Van den Heede, K., Sermeus, W., Diya, L., Clarke, S. P.,

Lesaffre, E., Vleugels, A., et al. (2009). Nurse staffing

and patient outcomes in Belgian acute hospitals:

Cross-sectional analysis of administrative data.

International Journal of Nursing Studies, 46(7),

928–939.

Veatch, R. (1993). Justice and outcomes research: The

ethical limits. Journal of Clinical Ethics, 4(3), 258–261.

Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010).

Measurement in nursing and health research (4th ed.).

New York: Springer.

Ware, J. R., & Sherbourne, J. E. (1992). The MOS, 36-item

short-form health survey (SF-36). I. Conceptual

framework and item selection. Medical Care, 30(6),

473–483.

World Health Organization (WHO). (2009). The

conceptual framework for the International

Classification for Patient Safety, Version 1.0, 2007-2008.

Retrieved July 30, 2013 from, http://www.who.int/

patientsafety/taxonomy/en.

Yoder, L., Xin, W., Norris, K., & Yan, G. (2013). Patient care

staffing levels and facility characteristics in US

hemodialysis facilities. American Journal of Kidney

Disease, 62(6), 1130–1140.

499CHAPTER 14 Outcomes Research

G L O S S A R Y

A

Abstract (adjective) Expressed without reference to any spe-

cific instance.

Abstract (noun) Clear, concise summary of a study, usually

limited to 100 to 250 words.

Acceptance rate The number or percentage of the subjects

who agree to participate in a study. The percentage is calcu-

lated by dividing the number of subjects agreeing to participate

by the number of subjects approached. For example, for a

study in which 100 subjects are approached and 90 agree to

participate, the acceptance rate is 90%: 90�100¼0.90� 100%¼90%.

Accessible population Portion of the target population to

which the researcher has reasonable access.

Accuracy Addresses the extent to which the instrument

measures what it is supposed to in a study; comparable to

validity.

Accuracy of a screening test Screening tests used to confirm

a diagnosis are evaluated in terms of their ability to assess the

presence or absence of a disease or condition correctly as com-

pared with a gold standard.

Administrative data Data collected within clinical agencies;

obtained by national, state, and local professional organiza-

tions and collected by federal, state, and local governmental

agencies.

Administrative database Resource created by insurance

companies, government agencies, and others not directly

involved in providing patient care; contain standardized sets

of data for enormous numbers of patients and providers

Algorithm Decision tree that provides a set of rules for solving

a particular practice problem. Its development usually is based

on research evidence and theoretical knowledge.

Alpha (a) Cutoff point used to determine whether the samples

being tested are members of the same population or of differ-

ent populations; alpha is commonly set at 0.05, 0.01, or 0.001.

Alternate forms reliability Degree of equivalence of two ver-

sions of the same paper and pencil instrument.

Analysis of covariance (ANCOVA) Statistical procedure in

which a regression analysis is carried out before performing

ANOVA; designed to reduce the variance within groups

by partialing out the variance caused by a confounding

variable.

Analysis of variance (ANOVA) Statistical test used to examine

differences among two or more groups by comparing the var-

iability between groups with the variability within each group.

Analyzing research reports Critical thinking skill that

involves determining the value of a study by breaking the con-

tents of a study report into parts and examining the parts for

accuracy, completeness, uniqueness of information, and

organization.

Anonymity Condition in which the subject’s identity cannot

be linked, even by the researcher, with his or her individual

responses.

Applied research Scientific investigation conducted to gener-

ate knowledge that will directly influence clinical practice.

Assent to participate in research Affirmative agreement to

participate in research by a child or adult with diminished

autonomy.

Associative hypothesis Hypothesis that identifies variables

that occur or exist together in the real world so that when

one variable changes, the other changes.

Assumption Statement taken for granted or considered true,

even though it has not been scientifically tested.

Attrition rate of a sample The percentage of subjects who

drop out of a study before it is completed, creating a threat

to the internal validity of the study. The attrition rate is calcu-

lated by dividing the number of subjects dropping out of a

study by the original sample size. For example, if the sample

size were 200 and 20 subjects dropped out of the study, then

20�200�100%¼10%. Authority Person with expertise and power who is able to influ-

ence the opinions and behaviors of others.

Autonomous agents Prospective subjects who are informed

about a proposed study and who can voluntarily choose

whether to participate.

B

Background for a problem Briefly identifies what we know

about a problem area in a research study.

Basic (pure) research Scientific investigations for the pursuit

of “knowledge for knowledge’s sake” or for the pleasure of

learning and finding truth.

Benchmarking Process of measuring outcomes from a health-

care agency for comparison with identified national standards.

Beneficence, principle of Principle that encourages the

researcher to do good and, “above all, do no harm.”

Benefit-risk ratio Ratio considered by researchers and

reviewers of research as they weigh potential benefits (positive

outcomes) and risks (negative outcomes) of a study; used to

promote the conduct of ethical research.

Best research evidence Produced by the conduct and synthe-

sis of numerous, high-quality studies in a health-related area.

The best research evidence is generated in the areas of health

promotion, illness prevention, and the assessment, diagnosis,

and management of acute and chronic illnesses.

Between-group variance A source of variation of the group

means around the grand mean; determined by conducting

analysis of variance statistical technique.

Bias Influence or action in a study that distorts the findings or

slants them away from the true or expected.

500

Bibliographical database Compilation of citations.

Bimodal distribution Describes a data set in which two modes

exist.

Bivariate analysis Statistical procedure in which the summary

values from two groups of the same variable or two variables

within a group are compared.

Bivariate correlation Measure of the extent of the linear rela-

tionship between two variables.

Borrowing Appropriation and use of knowledge from other

disciplines to guide nursing practice.

Bracketing Qualitative research technique of suspending or

setting aside what is known about an experience being studied.

Breach of confidentiality Accidental or direct action that

allows an unauthorized person to have access to raw study

data.

C

Case study In-depth analysis and systematic description of

one patient or a group of similar patients to promote under-

standing of nursing interventions.

Causal hypothesis Hypothesis that states the relationship

between two variables, in which one variable (independent

variable) is thought to cause or determine the presence of

the other variable (dependent variable).

Causality Relationship that includes three conditions: (1) there

must be a strong correlation between the proposed cause and

effect; (2) the proposed cause must precede the effect in time;

and (3) the cause must be present whenever the effect occurs.

Chi-square test of independence Used to analyze nominal

data to determine significant differences between observed fre-

quencies within the data and frequencies that were expected.

Citation Information necessary to locate a reference. The cita-

tion for a journal article includes the author’s name, year of

publication, title, journal name, volume number, issue num-

ber, and page numbers.

Clinical database Database created by providers such as hos-

pitals, HMOs, and healthcare professionals. The clinical data

are generated as a result of routine documentation of care

or in relation to a research protocol.

Clinical expertise A practitioner’s knowledge, skills, and past

experience in accurately assessing, diagnosing, and managing

an individual patient’s health needs.

Clinical importance Measure related to the practical relevance

of the findings of a study.

Cluster sampling Sampling in which a frame is developed that

includes a list of all the states, cities, institutions, or organiza-

tions (clusters) that could be used in a study; a randomized

sample is drawn from this list.

Coding Way of indexing or identifying categories in qualitative

data.

Coefficient of determination (R2) Computed from a matrix

of correlation coefficients; provides important information on

multicolinearity. This value indicates the degree of linear

dependencies among the variables.

Coefficient of multiple determination Statistical technique

that involves the use of multiple independent variables to pre-

dict one dependent variable; represented by an R 2 statistic.

Coercion Overt threat of harm or excessive reward inten-

tionally presented by one person to another to obtain

compliance—for example, offering prospective subjects a large

sum of money to participate in a dangerous research project.

Comparative descriptive design Design used to describe

differencesinvariablesintwoormoregroupsinanaturalsetting.

Complete review Type of institutional review process for stud-

ies with risks that are greater than minimal. The review of a

study is extensive or complete by an institutional review board.

Complex hypothesis Hypothesis that predicts the relation-

ship (associative or causal) among three or more variables;

thus, the hypothesis can include two (or more) independent

and/or two (or more) dependent variables.

Complex search Search that combines two or more concepts

or synonyms in one search. The concepts selected for search

may be based on the results of previous searches.

Comprehending a source Process completed by reading and

focusing on understanding the main points of an article or

other sources.

Comprehending research reports Critical thinking process

used in reading a research report, inwhich the focus is on under-

standing the major concepts and logical flow of ideas in a study.

Concept Term that abstractly describes and names an object or

phenomenon, thus providing it with a separate identity or

meaning.

Conceptual definition Definition that provides a variable or

concept with connotative (abstract, comprehensive, theoreti-

cal) meaning; established through concept analysis, concept

derivation, or concept synthesis.

Conceptual model Set of highly abstract, related constructs

that broadly explains phenomena of interest, expresses

assumptions, and reflects a philosophical stance.

Conclusion Synthesis and clarification of the meaning of study

findings.

Concrete thinking Thinking that is oriented to and limited by

tangible things or events observed and experienced in reality.

Conference proceedings Collection of papers presented for

review, which are later published, of a conference of major pro-

fessional organizations.

Confidence interval Probability of including the value of the

population in an interval estimate.

Confidentiality Management of private data in research in

such a way that only the researcher knows the subjects’ iden-

tities and can link them with their responses.

Confirmatory analysis Analysis performed to confirm expec-

tations regarding data expressed as hypotheses, questions, or

objectives.

Confounding variables Variables that cannot be controlled;

they may be recognized before the study is initiated or may

not be recognized until the study is in process.

Consent form Written form, tape recording, or video recording

used to document a subject’s agreement to participate in a study.

501Glossary

Construct Concept at very high levels of abstraction that has

general meaning.

Construct validity Measure of how well the conceptual and

operational definitions of variables match each other; deter-

mines whether the instrument measures the theoretical con-

struct that it purports to measure.

Content validity Extent to which the method of measurement

includes all the major elements relevant to the construct being

measured.

Control Writing of a prescription to produce the desired out-

comes in practice; in research, the imposing of rules by the

researcher to decrease the possibility of error and increase

the probability that the study’s findings are an accurate reflec-

tion of reality.

Control (or comparison) group The group of elements or

subjects not exposed to the experimental treatment in a study.

Convenience sampling Including subjects in the study who

happened to be in the right place at the right time, with the

addition of available subjects, until the desired sample size is

reached; also referred to as “accidental sampling.”

Correlational design Design used to examine relationships

between or among two or more variables in a single group

in a study.

Correlational research Systematic investigation of relation-

ships between two or more variables to explain the nature

of relationships in the world; does not examine cause and

effect.

Covered entity Public or private entity that processes or facil-

itates the processing of health information.

Covert data collection Data collection that occurs without

subjects’ knowledge or awareness.

Credibility The confidence of the reader about the extent to

which the researchers have produced results that reflect the

views of the participants; similar to validity in the critical

appraisal of quantitative studies.

Critical appraisal of qualitative studies Examines how the

integrity of the design and methods will affect the credibility

and meaningfulness of the findings and their usefulness in

clinical practice

Critical appraisal of research Examination of the strengths,

weaknesses, meaning, credibility, and significance of nursing

studies in generating knowledge.

Cross-sectional design Examination of a group of subjects

simultaneously in various stages of development, levels of

education, severity of illness, or stages of recovery to describe

changes in a phenomenon across stages

Current sources Sources published within 5 years prior to

acceptance of a respective manuscript for publication.

D

Data Information collected during a study.

Data analysis Technique used to reduce, organize, and give

meaning to data.

Data-based literature Consists of research reports, both

published reports in journals and books and unpublished

reports such as theses and dissertations.

Data collection Identification of subjects and the precise, sys-

tematic gathering of information (data) relevant to the

research purpose or the specific objectives, questions, or

hypotheses of a study.

Data use agreement Agreement that limits how the data set

with health information may be used and how it will be pro-

tected in research.

Deception Misinforming subjects for research purposes. After

a study is completed, subjects must be debriefed or informed

of the true purpose and outcomes of a study so that areas of

deception are clarified.

Decision theory Theory based on assumptions associated with

the theoretical normal curve; used in testing for differences

between groups, with the expectation that all the groups are

members of the same population. The expectation is expressed

as a null hypothesis, and the level of significance (alpha) is

often set at 0.05 before data collection.

Deductive reasoning Reasoning from the general to the spe-

cific or from a general premise to a particular situation.

Degrees of freedom (df) The freedom of a score’s value to

vary, given the values of other existing scores and the estab-

lished sum of these scores (df¼N�1). Demographic variables Characteristics or attributes of sub-

jects that are collected to describe the sample.

Dependability Documentation of steps taken and decisions

made during qualitative analysis.

Dependent groups Subjects or observations selected for data

collection that are in some way related to the selection of other

subjects or observations. For example, when subjects in the

control group are matched for age or gender with the subjects

in the experimental group, these groups are dependent groups.

Dependent (response or outcome) variable The response,

behavior, or outcome that is predicted or explained in research;

changes in the dependent variable are presumed to be caused

by the independent variable.

Description Identification of the characteristics of nursing

phenomena or of the relationships among these phenomena.

Descriptive correlational design Design used to describe var-

iables and examine relationships that exist in a situation.

Descriptive design Design used to identify a phenomenon of

interest, identify variables within the phenomenon, develop

conceptual and operational definitions of variables, and

describe variables.

Descriptive research Research that provides an accurate por-

trayal or account of the characteristics of a particular person,

event, or group in real-life situations; research that is con-

ducted to discover new meaning, describe what exists, deter-

mine the frequency with which something occurs, and

categorize information.

Descriptive statistics Statistics that allow the researcher to

organize the data in ways that give meaning and facilitate

insight, such as frequency distributions and measures of cen-

tral tendency and dispersion.

Design Blueprint for conducting a study; maximizes con-

trol over factors that could interfere with the validity of the

findings.

502 Glossary

Design validity The probability that the study findings are an

accurate reflection of reality.

Determining strengths and weaknesses in the studies The

second step in critically appraising studies to determine their

quality. To complete this step, the researcher must have knowl-

edge of what eachstepofthe researchprocess should belike from

expert sources such as this text and other research sources and

compare the study steps with these sources.

Digital object identifiers (DOIs) These have become standard

for the International Standards Organization (http://www.doi.

org/), but have not yet received universal support.

Diminished autonomy Condition of subjects whose ability to

give informed consent voluntarily is decreased because of legal

or mental incompetence, terminal illness, or confinement to an

institution.

Direct measures Concrete variables that can be measured

objectively with a specific measurement strategy, such as using

a scale to measure weight.

Directional hypothesis Hypothesis stating the specific nature

of the interaction or relationship between two or more

variables.

Discomfort and harm Phrase used to describe the degree of

risk for a subject participating in a study. These levels of risk

include no anticipated effects, temporary discomfort, unusual

levels of temporary discomfort, risk of permanent damage, or

certainty of permanent damage.

Dissertation An extensive, usually original research project

completed by a doctoral student as part of the requirements

for a doctoral degree.

Distal outcome An outcome removed from proximity to the

care or a service received and that is more influenced by exter-

nal (nontreatment) factors than is a proximal outcome.

Duplicate publication bias Bias referring to studies with pos-

itive results might be published more than once.

Dwelling with the data A phrase in qualitative data analysis

used to indicate that the researcher spent considerable time

reading and reflecting on the data.

E

Effect size The degree to which the phenomenon studied is pre-

sent in the population or to which the null hypothesis is false.

Electronic journals Journals that are published and available

on the Internet.

Elements in studies Persons (subjects or participants), events,

behaviors, or any other units examined in studies.

Eligibility criteria See Sampling criteria.

Emic approach Anthropological research approach to study-

ing behaviors from within a culture.

Empirical literature Knowledge derived from research. In

other words, the knowledge is based on data from research

(data-based).

Encyclopedia An authoritative compilation of information on

alphabetized topics that may provide background information

and lead to other sources, but is rarely cited in academic papers

and publications.

Environmental variables Types of extraneous variables com-

posing the setting in which a study is conducted.

Equivalence Part of reliability testing. The comparison of two

versions of the same paper and pencil instrument or of two

observers measuring the same event.

Error in physiological measures Error caused by environ-

mental factors, variations in operation of equipment, machine

instability and calibration, or misinterpreted electrical

signals.

Ethical principles Principles of respect for persons, benefi-

cence, and justice relevant to the conduct of research.

Ethnographic research Qualitative research methodology for

investigating cultures. The research involves collection,

description, and analysis of data to develop a theory of cultural

behavior.

Ethnonursing research Type of research that emerged from

Leininger’s Theory of Transcultural Nursing; focuses mainly

on observing and documenting interactions with people to

determine how daily life conditions and patterns influence

human care, health, and nursing care practices.

Etic approach Anthropological research approach to studying

behavior from outside the culture and examining similarities

and differences across cultures.

Evaluating the credibility and meaning of study findings

Determining the validity, credibility, significance, and meaning

of the study by examining the relationships among the steps of

the study, study findings, and previous studies

Evaluation phase Step of a critical appraisal in which the

reader examines the meaning, credibility, and significance of

a study according to set criteria and compares it with previous

studies conducted in the area.

Evidence-based guidelines Patient care guidelines based on

synthesized research findings from meta-analyses, integrative

reviews of research, and extensive clinical trials supported by

consensus from recognized national experts and affirmed by

outcomes obtained by clinicians.

Evidence-based practice (EBP) The conscientious integra-

tion of best research evidence with clinical expertise and

patients’ values and needs in the delivery of high-quality,

cost-effective health care.

Evidence-based practice centers (EPCs) Centers established

to develop evidence reports and technology assessments on

topics relevant to clinical, social science and behavioral, eco-

nomic, and other healthcare organization and delivery issues,

specifically those that are common, expensive, and/or signifi-

cant for the Medicare and Medicaid population.

Evidence of validity from contrasting groups Tested by

identifying groups that are expected (or known) to have con-

trasting scores on the instrument.

Evidence of validity from convergence Determined when a

relatively new instrument is compared with an existing instru-

ment(s) that measures the same construct. Both instruments

are administered to a sample concurrently, and results are eval-

uated using correlational analyses. If the measures are highly

positively correlated, the validity of each instrument is

strengthened.

503Glossary

Evidence of validity from divergence Correlational proce-

dures performed with the measures of two opposite concepts.

If the divergent measure (despair scale) is negatively correla-

tional with the other instrument (hope scale), validity for each

of the instruments is strengthened.

Exclusion sample criteria Sampling criteria or characteristics

that can cause a person or element to be excluded from the tar-

get population.

Exempt from review Designation given to studies that have

no apparent risks for the research subjects and thus are desig-

nated as exempt by an institutional review board.

Expedited review Institutional review process for studies that

have some risks, but the risks are minimal or no greater than

those ordinarily encountered in daily life or during the perfor-

mance of routine physical or psychological examinations.

Experiment Procedure in which subjects are randomized into

groups, data are collected, and statistical analyses are con-

ducted to support a premise.

Experimental design Design that provides the greatest

amount of control possible to examine causality more closely.

Experimental (or treatment) group Group of subjects receiv-

ing the experimental treatment.

Experimental research An objective, systematic, controlled

investigation to examine probability and causality among

selected variables for the purpose of predicting and controlling

phenomena.

Experimenter expectancy Expectation of the researcher that

can bias data. For example, experimenter expectancy occurs if

a researcher expects a particular intervention to relieve pain.

Explained variance Variation in values explained by the rela-

tionship between the two variables.

Explanation Clarification of relationships among variables

and identification of reasons why certain events occur.

Exploratory analysis Examining the data descriptively to

become as familiar as possible with it.

External validity Concerned with the extent to which study

findings can be generalized beyond the sample used in the

study

Extraneous variables Variables that exist in all studies and can

affect the measurement of study variables and the relationships

among these variables.

F

Fabrication in research A form of scientific misconduct in

research that involves making up results and recording or

reporting them.

Factor A category of several closely related variables that are

considered together.

Factor analysis Analysis that examines interrelationships

among large numbers of variables and disentangles those rela-

tionships to identify clusters of variables that are most closely

linked. Two common types of factor analysis conducted are

exploratory and confirmatory.

False-negative Outcome of a screening test indicating that a

disease is not present when it is present.

False-positive Outcome of a screening test indicating that a

disease is present when it is not present.

Falsification of research A type of scientific misconduct that

involves manipulating research materials, equipment, or pro-

cesses, or changing or omitting data or results, so that

the research is not accurately represented in the research record.

Feasibility of a study Suitability of a study determined by

examining the time and money commitment, researcher’s

expertise, availability of subjects, facility, and equipment,

cooperation of others, and study’s ethical considerations.

Field notes Notations recorded by the researcher while an

observation is taking place.

Findings The translated and interpreted results from a study.

Focus groups Measurement strategy in which groups are

assembled to obtain the participants’ perceptions in focused

areas in settings that are permissive and nonthreatening in a

qualitative study.

Focused ethnography An observation of an organizational

culture for a short period of time

Forest plot Type of diagram used to present the meta-analysis

results of studies with dichotomous outcomes

Framework Abstract, logical structure of meaning, such as a

portion of a theory, that guides the development of the study,

is tested in the study, and enables the researcher to link the

findings to nursing’s body of knowledge.

Frequency distribution Statistical procedure that lists all pos-

sible measures of a variable and tallies each datum on the

listing.

Funnel plots Graphic representations of possible effect sizes

(ESs) for interventions in selected studies.

G

Generalization Extension of the implications of the findings

from the sample or situation that was studied to a larger pop-

ulation or situation.

Going native A complication of observation in which the

researcher becomes a part of the culture and loses her or his

ability to observe clearly.

Gold standard The most accurate means of currently diagnos-

ing a particular disease; serves as a basis for comparison with

newly developed diagnostic or screening tests; also, a gold stan-

dard for managing patients’ care that is linked to patient

outcomes.

Grand Nursing Theory Abstract, broad scope theory.

Grey literature Studies that have limited distributions, such as

theses and dissertations, unpublished research reports, articles

in obscure journals, articles in some online journals, confer-

ence papers and abstracts, conference proceedings, research

reports to funding agencies, and technical reports.

Grounded theory research Inductive research technique

based on symbolic interaction theory; conducted to discover

the problems that exist in a social scene and the process that

persons involved use to handle them. It involves formulation,

testing, and redevelopment of propositions until a theory is

developed.

504 Glossary

Grouped frequency distribution Means of grouping contin-

uous measures of data into categories.

Grove Model for Implementing Evidence-Based Guidelines

in Practice In this model, nurses identify a practice problem,

search for the best research evidence to manage the problem in

their practice, and use an evidence-based guideline to manage

the problem.

H

Health Insurance Portability and Accountability Act (HIPAA)

Federal regulations implemented in 2003 to protect an individ-

ual’s health information. The HIPAA Privacy Rule affects not

only the healthcare environment but also the research con-

ducted in this environment.

Heterogeneity Variations in study areas such as sample char-

acteristics, sample size, design, types of interventions, outcome

variables, and measurement methods.

Heterogeneous sample A sample in which subjects have a

broad range of values being studied, which increases the rep-

resentativeness of the sample and the ability to generalize from

the accessible population to the target population.

Highly controlled setting Artificiallyconstructed environment

developed for the sole purpose of conducting research, such as a

laboratory, research or experimental center, or test unit.

Highly sensitive test A screening test that indicates a true-

positive test result for a large proportion of patients with

the disease.

Highly specific test A screening test that indicates a true-

negative test result for a large proportion of patients without

the disease.

Historical research Narrative description or analysis of events

that occurred in the remote or recent past.

Homogeneity A type of reliability testing used primarily with

paper and pencil instruments or scales to address the

correlation of each question to the other questions in the scale.

Homogeneous sample Sample in which subjects’ scores on

selected measurement methods in a study are similar, resulting

in a limited or narrow distribution or spread of scores.

Human rights Claims and demands that have been justified in

the eyes of an individual or by the consensus of a group of peo-

ple and are protected in research.

Hypothesis Formal statement of the expected relationship

between two or more variables in a specified population.

I

Identifying the steps of the research process The first step

in critical appraisal. It involves understanding the terms and

concepts in the report, as well as identifying study elements

and grasping the nature, significance, and meaning of these

elements.

Implications for nursing The meaning of research conclu-

sions for the body of nursing knowledge, theory, and practice.

Implicit framework Rudimentary ideas for the framework of a

theory or portions of a theory expressed in an introduction or

in a literature review in which linkages among variables found

in previous studies are discussed.

Inclusion sample criteria Those sampling criteria or charac-

teristics that the subject or element must possess to be consid-

ered part of the target population.

Independent groups Study groups chosen so that the selection

of one subject is unrelated to the selection of other subjects. For

example, if subjects are randomly assigned to a treatment

group or a comparison group, the groups are independent.

Independent (treatment or intervention) variable Treat-

ment or intervention that is manipulated or varied by the

researcher to cause an effect on the dependent variable.

Index Library resource that can be used to identify journal arti-

cles and other publications relevant to a topic.

Indirect measures or indicators Methods used with abstract

concepts that are not measured directly; rather, indicators or

attributes of the concepts are used to represent the abstraction

and are measured in the study.

Individually identifiable health information (IIHI) “. . . any

information, including demographic information collected

from an individual that is created or received by healthcare

provider, health plan, or healthcare clearinghouse; and related

to past, present, or future physical or mental health condition

of an individual, the provision of health care to an individual,

or the past, present, or future payment for the provision of

health care to an individual, and identifies the individual; or

with respect to which there is a reasonable basis to believe that

the information can be used to identify the individual” (U.S.

Department of Health and Human Services, 2003, 45 CFR,

Section 160.103).

Inductive reasoning Reasoning from the specific to the gen-

eral, in which particular instances are observed and then com-

bined into a larger whole or general statement.

Inference Generalization from a specific case to a general truth,

from a part to the whole, from the concrete to the abstract, or

from the known to the unknown.

Inferential statistics Statistics designed to address objectives,

questions, and hypotheses in a study to allow inference from

the study sample to the target population.

Informed consent Agreement by a prospective subject to par-

ticipate voluntarily in a study after he or she has assimilated

essential information about the study.

Institutional review Process of examining studies for ethical

concerns by a committee of peers.

Institutional review board (IRB) A committee that reviews

research to ensure that the investigator is conducting the

research ethically.

Instrumentation Component of measurement in which spe-

cific rules are applied to develop a measurement device or

instrument.

Integrative review of the literature Rigorous analysis and

synthesis of results from independent quantitative and quali-

tative studies and theoretical and methodological literature to

determine the current knowledge (what is known and not

known) for a particular concept, measurement methods, or

practice topic.

505Glossary

Integrative review of research Review conducted to identify,

analyze, and synthesize the results from independent studies to

determine the current knowledge (what is known and not

known) in a particular area.

Intellectual critical appraisal of a study Careful examination

of all aspects of a study to judge the strengths, weaknesses,

meaning, credibility, and significance of the study based on

previous research experience and knowledge of the topic.

Internal consistency Measures the extent to which all the

items in an instrument consistently measure the construct.

Internal validity The extent to which the effects detected in the

study are a true reflection of reality rather than the result of

extraneous variables.

Interpretation Process whereby the researcher places the find-

ings in a larger context and may link different themes or factors

in the findings to each other.

Interpretation of research outcomes Process in which re-

searchers examine the results from data analysis, form conclu-

sions, consider the implications for nursing, explore the

significance of the findings, generalize the findings, and sug-

gest further studies.

Interrater reliability Comparison of two observers or two

judges in a study

Interval-level measurement Measurement that uses interval

scales, which have equal numerical distances between intervals

and also follows the rules of mutually exclusive categories,

exhaustive categories, and rank ordering, such as temperature.

Intervention Treatment or independent variable manipulated

during the conduct of a study to produce an effect on the

dependent or outcome variables.

Intervention fidelity Fidelity that includes the detailed descrip-

tion of the essential elements of the intervention and the consis-

tent implementation of the intervention during the study.

Interview Structured or unstructured oral communication

between the researcher and subject or study participant during

which information is obtained for a study.

Intraproject sampling Additional sampling done during data

collection and analysis to promote the development of quality

study findings.

Intuition Insight or understanding of a situation or an event as

a whole that usually cannot be logically explained.

Invasion of privacy Sharing private information with others

without a person’s knowledge or against his or her will.

Iowa Model of Evidence-Based Practice Provides direction

for the development of EBP in a clinical agency. In a healthcare

agency, there are triggers that initiate the need for change; the

focus should always be on making changes based on the best

research evidence.

J

K

Key informant Person in an ethnographic study with extensive

knowledge and influence in a culture with whom a researcher

may form a close bond.

Key words Major concepts or variables of a research problem

or topic used to begin a search of a database.

Knowledge Information that is acquired in a variety of ways, is

expected to be an accurate reflection of reality, and is incorpo-

rated and used to direct a person’s actions.

L

Landmark studies Major projects generating knowledge that

influence a discipline and sometimes society in general.

Levels of measurement Organized set of rules for assigning

numbers to objects so that a hierarchy in measurement from

low to high is established. The levels of measurement are nom-

inal, ordinal, interval, and ratio.

Level of statistical significance Probability level at which the

results of statistical analysis is judged to indicate a statistically

significant difference between groups. The level of significance

for most nursing studies is 0.05.

Likelihood ratios (LRs) Additional calculations that can

help researchers determine the accuracy of diagnostic or

screening tests, which are based on the sensitivity and specific-

ity results.

Likert scale Scale designed to determine the opinions or atti-

tudes of study subjects; contains a number of declarative state-

ments, with a scale after each statement

Limitations Theoretical and methodological restrictions

in a study that may decrease the generalizability of the

findings.

Line of best fit Best reflection of the values on the scatterplot.

Literature All written sources relevant to the topic that the

researcher has selected, including articles published in period-

icals or journals, Internet publications, monographs, encyclo-

pedias, conference papers, theses, dissertations, clinical

journals, textbooks, and other books.

Literature review Review of theoretical and empirical sources

to generate a picture of what is known and not known about a

particular problem.

Location bias of studies Bias that can occur if studies are pub-

lished in lower impact journals and indexed in less searched

databases.

Longitudinal design Design that involves collecting data from

the same subjects at different points in time; might also be

referred to as repeated measures.

Low statistical power Statistical issue that increases the prob-

ability of concluding that there is no significant difference

between samples when actually there is a difference (type II

error).

M

Manipulation Moving around or controlling specific attri-

butes of a treatment or intervention in a study.

Maps (or models) Diagrams that graphically express the con-

cepts and relationships of theories or frameworks.

Mean The value obtained by summing all the scores and divid-

ing the total by the number of scores being summed.

Mean difference A standard statistic that identifies the abso-

lute difference between two groups.

506 Glossary

Measurement Process of assigning numbers to objects, events,

or situations in accordance with some rule.

Measurement error Difference between what exists in reality

and what is measured by a research instrument.

Measure of central tendency Statistical procedure (mode,

median, and mean) for determining the center of a distribu-

tion of scores.

Measure of dispersion Statistical procedure (range, difference

scores, sum of squares, variance, and standard deviation) for

examining how scores vary or are dispersed around the mean.

Median Score at the exact center of the ungrouped frequency

distribution.

Mentorship Intense form of role modeling in which an expert

nurse serves as a teacher, sponsor, guide, exemplar, and coun-

selor for a novice nurse.

Meta-analysis Statistical analysis carried out to integrate and

synthesize findings from completed studies to determine what

is known and not known about a particular research area.

Meta-summary Synthesis of multiple primary qualitative

studies to develop a description of current knowledge in an

area.

Meta-synthesis Synthesis of qualitative research involving the

critical analysis of primary qualitative studies and synthesis of

findings into a new theory or framework for the topic of

interest.

Methodological bias Bias related to design and data analysis

problems in studies. For example, studies might have limita-

tions related to the sample, intervention, outcome measure-

ments, and analysis techniques that result in methodological

bias.

Middle-range theories Theories that are relatively concrete

and specific in focus; include a limited number of concepts

and propositions. These theories are tested by empirical

research.

Minimal risk Research subject’s risk of harm anticipated in the

proposed study that is not greater, considering probability and

magnitude, than that ordinarily encountered in daily life or

during the performance of routine physical or psychological

examinations.

Mixed-methods approach Approach that offers investigators

the ability to use the strengths of qualitative and quantitative

research designs. Mixed-methods research is characterized as

research that contains elements of qualitative and quantitative

approaches

Mixed-methods systematic review Synthesis that includes

various study designs, such as qualitative research and quasi-

experimental, correlational, and descriptive quantitative

studies

Mixed results Study results that include significant and non-

significant findings.

Mode Numerical value or score that occurs with the greatest

frequency in a distribution but does not necessarily indicate

the center of the data set.

Model testing design Design that requires all concepts rele-

vant to the model to be measured and the relationships among

these concepts examined

Moderator, or facilitator Conductor of a focus group, who

may or may not be the researcher.

Monographs Sources that usually are written once, such as

books, booklets of conference proceedings, or pamphlets,

and may be updated with a new edition.

Multicausality Recognition that a number of interrelated vari-

ables can cause a particular effect.

Multiple regression Extension of simple linear regression;

more than one independent variable is analyzed.

N

Natural (field) setting Uncontrolled, real-life setting in which

research is conducted, such as a subject’s home, workplace, and

school.

Necessary relationship Relationship in which one variable or

concept must occur for the second variable or concept to

occur.

Negative likelihood ratio The ratio of true-negative results to

false-negative results,

Negative relationship Relationship in which one variable

or concept changes (its value increases or decreases), and the

other variable or concept changes in the opposite direction.

Network sampling Sampling technique that takes advantage

of social networks and the fact that friends tend to have

characteristics in common; subjects meeting the sample

criteria are asked to assist in locating others with similar

characteristics.

Nominal-level measurement The lowest of the four types of

measurement categories. It is used when data can be organized

into categories of a defined property that are exclusive and

exhaustive but the categories cannot be rank-ordered, such

as gender, ethnicity, marital status, and diagnoses.

Nondirectional hypothesis Hypothesis that states that a rela-

tionship exists but does not predict the exact nature of the

relationship.

Nonequivalent comparison group design Design in which

the control group is not selected by random means, such as

the one-group post-test–only design, post-test–only design

with nonequivalent groups, and one-group pretest–post-test

design.

Nonexperimental design Descriptive and correlational

design that focuses on examining variables as they naturally

occur in an environment, not on the implementation of a

treatment by the researcher.

Nonparametric analysis Analysis performed when variables

are measured at the nominal and ordinal levels.

Nonprobability sampling Sampling in which not every ele-

ment of the population has an opportunity for selection, such

as convenience sampling, quota sampling, purposive sam-

pling, and network sampling.

Nonsignificant results Results that are negative or contrary to

the researcher’s hypotheses; the results may accurately reflect

reality or may be caused by study weaknesses.

Nontherapeutic research Research conducted to generate

knowledge for a discipline; the results might benefit future

patients but will probably not benefit the research subjects.

507Glossary

Normal curve Symmetrical, unimodal, bell-shaped curve that

is a theoretical distribution of all possible scores; no real dis-

tribution exactly fits the normal curve.

Null hypothesis (H0) Hypothesis stating that no relationship

exists between the variables being studied; a hypothesis

used for statistical testing and for interpreting statistical

outcomes.

Nurse’s role in outcomes The nurse’s role in outcomes of a

study has three subcomponents—nurse’s” independent role,

nurse’s dependent role, and nurse’s interdependent role. Inde-

pendent role functions include assessment, diagnosis, nurse-

initiated interventions, and follow-up care.

Nursing Care Report Card Tool created by the American

Nurses Association in 1994 to facilitate benchmarking or set

a desired standard that would allow comparisons of hospitals

in terms of their nursing care quality.

Nursing process Subset of the problem-solving process. Steps

include assessment, diagnosis, plan, implementation, evalua-

tion, and modification.

Nursing research Scientific process that validates and refines

existing knowledge and generates knowledge that directly

and indirectly influences clinical nursing practice.

Nursing-sensitive patient outcome (NSPO) Outcome that

is sensitive because it is influenced by nursing care decisions

and actions. It may not be caused by nursing but is associated

with nursing.

O

Observation A fundamental method of gathering data for

qualitative studies, especially ethnographic studies.

Observational measurement Use of structured and unstruc-

tured observations to measure study variables.

Odds ratio (OR) The ratio of the odds of an event occurring in

one group, such as the treatment group, to the odds of it occur-

ring in another group, such as the standard care group.

One-tailed test of significance Analysis used with directional

hypotheses, in which extreme statistical values of interest are

thought to occur in a single tail of the normal curve.

Open-ended interview Interview with a defined focus but no

fixed sequence of questions. The questions addressed may

change as the researcher gains insight from previous interviews

and observations and respondents are encouraged to raise

important issues not addressed by the researcher.

Operational definition Description of how variables or con-

cepts will be measured or manipulated in a study.

Ordinal-level measurement Method whereby data are

assigned to categories that can be ranked. To rank data, one

category is judged to be (or is ranked) higher or lower, or better

or worse, than another category. The intervals between the

ranked data are not necessarily equal, such as ranking pain

as mild, moderate, and severe.

Outcome reporting bias Bias that occurs when study results

are not reported clearly and with complete accuracy.

Outcomes research Important scientific methodology

developed to examine the end results of patient care. The strat-

egies used in outcomes research are a departure from those used

in traditional scientific endeavors; they incorporate evaluation

research, epidemiology, and economic theory perspectives.

Outliers Extreme scores or values caused by inherent variabil-

ity, errors of measurement or execution, or error in identifying

the variables important in explaining the nature of the phe-

nomenon under study.

P

Paired (or dependent) groups Subjects or observations

selected for data collection which are related in some way to

the selection of other subjects or observations.

Parametric analysis Analysis of data for variables measured at

the interval and ratio levels that are normally distributed.

Interval and ratio levels of data are often included together

because the analysis techniques are the same whether the data

are at the interval or ratio level of measurement.

Paraphrasing Clearly and concisely restating the ideas of an

author in the researcher’s own words.

Partially controlled setting Environment that is manipulated

or modified in some way by the researcher.

Participant Individual who participates cooperatively in stud-

ies with researchers. Qualitative researchers use the term par-

ticipants; quantitative researchers might call them subjects or

participants.

Patient health outcomes Outcomes based on the Nursing

Role Effectiveness Model. The outcomes of the independent

role are clinical and symptom control, freedom from compli-

cations, functional status and self-care, and knowledge of dis-

ease and its treatment, satisfaction, and costs.

Pearson product-moment correlation Parametric test used

to determine relationships among variables.

Peer-reviewed Refers to publications for which scholars famil-

iar with the topic of the research read the report and validate its

accuracy and appropriateness of the methodology used in the

study.

Percentage distributions Percentage of the sample whose

scores fall into a specific group and the number of scores in

that group.

Periodicals Literature sources such as journals that are pub-

lished over time and are numbered sequentially for the years

published.

Permission to participate in research The agreement of par-

ent(s) or guardian to the participation of their child or ward in

research.

Personal experience Knowledge gained through participation

in rather than observation of an event, situation, or circum-

stance. Benner (1984) described five levels of experience in

the development of clinical nursing knowledge and expertise:

(1) novice, (2) advanced beginner, (3) competent, (4) profi-

cient, and (5) expert.

Phenomenology A philosophy and a group of research

methods congruent with the philosophy.

Phenomenon (plural, phenomena) An occurrence or a cir-

cumstance that is observed, something that impresses the

observer as extraordinary, or something that appears to and

is constructed by the mind.

508 Glossary

Philosophies Rational, intellectual explorations of truths;

principles of being, knowledge, or conduct.

Physiological measures Measurement methods used to

quantify the level of functioning of living beings.

PICOS format Format used to formulate a relevant clinical

question for a systematic review. Elements include population

or participants of interest, intervention needed for practice,

comparisons of interventions to determine the best for prac-

tice, outcomes needed for practice, and study design.

Pilot study Smaller version of a proposed study conducted to

develop and refine the methodology, such as the treatment or

intervention, instruments, or data collection process to be used

in the larger study.

Plagiarism A type of scientific misconduct that appropriates

another person’s ideas, processes, results, or words without

giving appropriate credit, including those obtained through

confidential review of others’ research proposals and

manuscripts.

Population All elements (people, objects, events, or sub-

stances) that meet the sample criteria for inclusion in a study;

sometimes referred to as a target population.

Population-based studies Important type of outcomes

research that involves studying health conditions in the context

of the community rather than the context of the medical system.

Positive likelihood ratio The ratio of the true-positive results

to false-positive results. It is calculated by:

PositiveLR ¼ sensitivity� 100%�specificityð Þ Positive relationship Relationship in which one variable

changes (its value increases or decreases) and the second var-

iable changes in the same direction.

Posthoc analyses Statistical techniques performed in studies

with more than two groups to determine which groups are sig-

nificantly different. For example, ANOVA may indicate signif-

icant differences among three groups, but the posthoc analyses

indicate specifically which groups are different.

Power Probability that a statistical test will detect a significant

difference or relationship that exists; power analysis is used to

determine the power of a study.

Power analysis Technique used to determine the risk of a type

II error so that the study can be modified to decrease the risk if

necessary and ensure that the study has adequate sample size.

Practice theories Very specific theories developed to explain a

particular element of practice. These theories can be generated

through research and tested by research.

Precision Accuracy with which the population parameters

have been estimated within a study; also used to describe

the degree of consistency or reproducibility of measurements

with physiological instruments.

Prediction Estimation of the probability of a specific outcome

in a given situation that can be achieved through research.

Predictive correlational design Design developed to predict

the value of one dependent variable based on values obtained

for other independent variables; an approach to examining

causal relationships between or among variables.

Premise Proposition or statement of the proposed relationship

between two or more concepts.

Primary data Data collected for a particular study.

Primary source Source whose author originated or is respon-

sible for generating the ideas published.

Principle of beneficence Ethical principle that encourages

researchers to do good and, “above all, do no harm.”

Principle of justice Ethical principle that states that human

subjects should be treated fairly in terms of the benefits and

risks of research.

Principle of respect for persons Ethical principle indicating

that people should be treated as autonomous agents with

the right to self-determination and the freedom to participate

or not participate in research.

Privacy Freedom to determine the time, extent, and general cir-

cumstances under which private information will be shared

with or withheld from others.

Probability Chance that a given event will occur in a situation;

addresses the relative rather than the absolute causality of

events.

Probability sampling Random sampling technique in which

every member (element) of the population has a probability

higher than zero of being selected for the sample, such as sim-

ple random sampling, stratified random sampling, cluster

sampling, and systematic sampling.

Probability theory Theory addressing statistical analysis from

the perspective of the extent of a relationship or the probability

of accurately predicting an event.

Probe Query by the researcher to obtain more information

from the participant about a particular question.

Problem-solving process Systematic identification of a prob-

lem, determination of goals related to the problem, identifica-

tion of possible approaches to achieve those goals,

implementation of selected approaches, and evaluation of goal

achievement.

Problem statement Statement that concludes the discussion

of a problem and indicates the gap in the knowledge needed

for practice. The problem statement usually provides a basis

for the study purpose.

Process Purpose, series of actions, and goal.

Proposition Abstract statements that further clarify the rela-

tionship between two concepts in theories.

Prospective cohort study An epidemiological study in which

the researcher identifies a group of people at risk for experienc-

ing a particular event and then follows them over time to

observe whether or not the event occurs.

Proximal outcome An outcome close to the delivery of care.

Public library Library that serves the needs of the community

in which it is located; usually contains few research reports.

Purposeful (or purposive) sampling Judgmental or selective

sampling that involves the conscious selection by the researcher

of certain participants or elements to include in a study. This

sampling strategy is often used in qualitative research.

Q

Qualitative research Systematic, subjective methodological

approach used to describe life experiences and give them

meaning.

509Glossary

Qualitative research critical appraisal process Three-part

process that consists of (1) identifying the components of

the qualitative research process in studies, (2) determining

study strengths and weaknesses, and (3) evaluating the trust-

worthiness, credibility, and meaning of study findings.

Quality and Safety Education for Nurses (QSEN) An initia-

tive focused on developing the requisite knowledge, skills, and

attitude (KSA) statements for each of the competencies for

prelicensure and graduate education.

Quality of care Outcome examined in the conduct of out-

comes research.

Quantitative research Formal, objective, systematic process

used to describe variables, test relationships between them,

and examine cause and effect interactions among variables.

Quantitative research process Conceptualizing, planning,

implementing, and communicating the findings of a quantita-

tive research project.

Quasi-experimental design Types of design developed to

determine the effectiveness of interventions in quantitative

quasi-experimental studies.

Quasi-experimental research Type of quantitative research

conducted to explain relationships, clarify why certain events

happen, and examine causality between selected independent

and dependent variables.

Questionnaire Printed self-report form designed to elicit

information that can be obtained through written or verbal

responses of the subject.

Quota sampling Convenience sampling technique with an

added strategy to ensure the inclusion of subjects who are

likely to be underrepresented in the convenience sample, such

as women, minority groups, and undereducated persons.

R

Random assignment to groups Procedure used to assign

subjects randomly to a treatment or control group; subjects

have an equal probability of being assigned to either group.

Random measurement error Error that causes individual

subjects’ observed scores to vary haphazardly around their true

scores.

Random sampling Technique in which every member (ele-

ment) of the population has a probability higher than zero

for being selected for a sample, which increases the sample’s

representativeness of the target population.

Random variation The expected difference in values that

occurs when the researcher examines different subjects from

the same sample.

Randomized controlled trial (RCT) Classic means of examin-

ing the effects of various treatments in which the effects of a

treatment are examined by comparing the treatment group

with the nontreatment group.

Range The simplest measure of dispersion. The range is deter-

mined by subtracting the lowest score from the highest score or

just identifying the lowest and highest scores.

Rating scale Scale that lists an ordered series of categories of a

variable; assumed to be based on an underlying continuum.

Ratio-level measurement The highest form of measurement;

meets all the rules of other forms of measurement—mutually

exclusive categories, exhaustive categories, ordered ranks,

equally spaced intervals, and a continuum of values; also

includes an absolute zero.

Readability level Measurement focused on the study partici-

pants’ ability to read and comprehend the content of an instru-

ment or scale

Reading research reports Process used to learn about

research studies; skills used include skimming, comprehend-

ing, and analyzing the content of the report.

Reasoning Processing and organizing ideas to reach conclu-

sions; types of reasoning include problematic, operational,

dialectic, and logistic.

Recommendations for further study Suggestions provided

by a study’s researcher for ways to design a better study next

time. Recommendations can include replications or repeating

the design with a different or larger sample, using different

measurement methods, or testing a new treatment.

Refereed journal Journal that uses referees or expert reviewers

to determine whether a manuscript will be accepted for

publication.

Reference A documentation of the origin of the cited quote or

paraphrased idea that provides enough information for the

reader to locate the original material.

Referencing Comparing a subject’s score against a standard;

used in norm-referenced and criterion-referenced testing.

Refusal rate The percentage of subjects who declined to partic-

ipate in the study. The study should include their rationale for

not participating. The refusal rate is calculated by dividing the

number refusing to participate by the number of potential

subjects approached. For example, if 100 subjects are

approached and 15 refuse to participate, the refusal rate is

15�100¼0.15�100%¼15%. Regression analysis Statistical procedure used to predict the

value of one variable using known values of one or more other

variables.

Relational statement Declaration that a relationship of some

type exists between (or among) two or more concepts.

Relative advantage Extent to which an innovation is per-

ceived to be better than current practice.

Relevant studies Investigations or studies that have a specific

focus in a researcher’s area of interest.

Reliability Extent to which an instrument consistently mea-

sures a concept; three types of reliability are stability, equiva-

lence, and homogeneity.

Reliability testing Measure of the amount of random error in

the measurement technique.

Replication studies Studies that are reproduced or repeated to

determine whether similar findings will be obtained.

Researcher-participant relationship Relationship that has an

impact on the collection and interpretation of data. The

researcher creates a respectful relationship with each partici-

pant, which includes being honest and open about the purpose

and methods of the study.

510 Glossary

Representativeness Refers to the representativeness of a sam-

ple in a study or the degree to which the sample, accessible

population, and target population are alike.

Research Diligent, systematic inquiry or investigation to

validate and refine existing knowledge and generate new

knowledge.

Research-based protocol Document providing clearly devel-

oped steps for implementing a treatment or intervention in

practice that is based on findings from studies.

Research concepts The ideas, experiences, situations, or

events that are investigated in qualitative research.

Research design Blueprint for conducting a study. It maxi-

mizes control over factors that could interfere with the

validity of the findings and guides the planning and implemen-

tation of a study in a way that is most likely to achieve the

intended goal.

Research hypothesis Alternative hypothesis to the null

hypothesis; states that a relationship exists between two or

more variables.

Research misconduct Intentional deviation from practices

commonly accepted within the scientific community for pro-

posing, conducting, or reporting research; may include fabrica-

tion, falsification, or plagiarism; does not include honest errors

or honest differences in interpretation or judgment of data.

Research objective Clear, concise, declarative statement

expressed to direct a study; focuses on identifying and describ-

ing variables and relationships among variables.

Research outcomes Conclusions of findings, generalization

of findings, implications of findings for nursing, and sugges-

tions for further study presented in the discussion section of

the research report.

Research problem An area of concern in which there is a gap

in the knowledge base needed for nursing practice. Research

is conducted to generate essential knowledge to address the

practice concern, with the ultimate goal of providing

evidence-based practice. The research problem in a study

needs to include significance, background, and problem

statement.

Research process Process that requires an understanding of a

unique language; involves rigorous application of a variety of

research methods.

Research purpose Concise, clear statement of the specific goal

or aim of the study. The purpose is generated from the

problem.

Research question Concise interrogative statement developed

to direct a study; focuses on describing variables, examining

relationships among variables, and determining the differences

between two or more groups.

Research report Report summarizing the major elements of a

study and identifying the contributions of that study to nurs-

ing knowledge.

Research setting The site or location used to conduct a study.

Research topic Concept or broad problem area that provides

the basis for generating numerous questions and research

problems.

Research variables or concepts The qualities, properties, or

characteristics identified in the research purpose and objec-

tives or questions that are observed or measured in a study.

Researcher-participant relationship Relationship between

the researcher and individual participants being studied in

qualitative research.

Results Outcomes from data analysis that are generated for

each research objective, question, or hypothesis; results can

be mixed, nonsignificant, significant and not predicted, signif-

icant and predicted, or unexpected.

Retrospective cohort study An epidemiological study in

which the researcher identifies a group of people who have

experienced a particular event and study their outcomes.

Review of literature Summary of current theoretical and

empirical sources to generate a picture of what is known

and not known about a particular problem.

Review of relevant literature Review of current studies con-

ducted to generate what is known and not known about a

problem and to determine whether the knowledge is ready

for use in practice.

Rigor Excellence in research; attained through the use of disci-

pline, scrupulous adherence to detail, and strict accuracy.

Risk difference (RD) (or absolute risk reduction) The risk of

an event in the experimental group minus the risk of the event

in the control or standard care group.

Risk ratio, or relative risk (RR) The ratio of the risk of subjects

in the intervention group to the risk of subjects in the control

group for having a particular health outcome.

Role modeling Process of teaching less experienced profes-

sionals by demonstrating model behavior.

S

Sample Subset of the population that is selected for a study.

Sample attrition Withdrawalorlossofsubjectsfromastudythat

can be expressed as the number of subjects withdrawing or

a percentage. The percentage is the sample attrition rate; it

is best if researchers include both the number of subjects

withdrawingandtheattritionrate.(SeeAttritionrateofasample.)

Sample characteristics Demographic data analyzed to pro-

vide a picture of the sample.

Sample retention Number of subjects who remain in and

complete a study.

Sample size Number of subjects, events, behaviors, or situa-

tions examined in a study.

Sampling Process of selecting a group of people, events, behav-

iors, or other elements that are representative of the popula-

tion being studied.

Sampling, or eligibility, criteria List of the characteristics

essential for inclusion or exclusion in the target population.

Sampling frame List of every member of the population;

sampling criteria are used to define membership in the

population.

Sampling method, or plan Strategies used to obtain a sample,

including probability and nonprobability sampling tech-

niques; also called a sampling plan.

511Glossary

Saturation of information Phenomenon that occurs when

additional sampling provides no new information or there

is redundancy of previously collected data. Sample size in

a qualitative study is determined when saturation of data

occurs.

Scale Self-report form of measurement composed of several

items thought to measure the construct being studied; the

subject responds to each item on the continuum or scale

provided.

Scatterplot Diagram or figure showing the dispersion of

scores on a variable from a study, or depicting the relationship

of scores on one variable with scores on another variable. A

scatterplot has two scales, horizontal (x-axis) and vertical

(y-axis).

Scientific theory Theory that has been repeatedly tested

through research with valid and reliable methods of measuring

each concept and relational statement.

Secondary analysis Reanalysis of information or data that has

previously been collected by another researcher or

organization.

Secondary data Data collected from previous research, stored

in a database, and used by other researchers to address their

study purposes.

Secondary source Source whose author summarizes or

quotes content from primary sources.

Semistructured interview Interview with a fixed set of ques-

tions and no fixed responses.

Sensitivity The proportion of patients with the disease who

have a positive test result, or true-positive.

Sensitivity of physiological measures Amount of change of

a parameter that can be measured precisely.

Setting Location for conducting research; can be natural, par-

tially controlled, or highly controlled.

Significance of a research problem Indicates the importance

of the problem to nursing and health care and to the health of

individuals, families, and communities.

Significant and unpredicted results Results that are opposite

of those predicted by the researcher; indicate that flaws are pre-

sent in the logic of both the researcher and theory being tested.

Significant results Results that agree with those identified by

the researcher.

Simple hypothesis Hypothesis stating the relationship (asso-

ciative or causal) between two variables.

Simple linear regression Name of analysis procedure in which

oneindependent variableisusedtopredicta dependentvariable.

Simple random sampling Random selection of elements

from the sampling frame for inclusion in a study.

Skewness Absence of symmetry in the curve formed by the

distribution of scores; distribution can be positively or nega-

tively skewed.

Skimming research reports Quickly reviewing a source to

gain a broad overview of the content by reading the title,

author’s name, abstract or introduction, headings, one or

two sentences under each heading, and discussion section.

Specific proposition Relational statement made in a narrow

way, which makes the statement more concrete and testable.

Specificity The proportion of patients without the disease who

have a negative test result, or true-negative.

Stability Type of measurement reliability that is concerned

with the consistency of repeated measures; usually referred

to as test-retest reliability.

Standard deviation Measure of dispersion calculated by tak-

ing the square root of the variance.

Standardized mean difference (SMD), or d A summary sta-

tistic that is reported in a meta-analysis when the same out-

come is measured by different scales or methods.

Standardized mortality ratio (SMR) The observed number

of deaths divided by the expected number of deaths and mul-

tiplied by 100. SMR is regarded as a measure of the relative risk

of the studied group to die of a particular condition.

Standardized score Score used to express deviations from the

mean (difference scores) in terms of standard deviation units,

such as Z-score, in which the mean is 0 and the standard devi-

ation is 1.

Standard of care Norm on which quality of care is judged.

Statements Express claims that compute to a theory; theories

include existence and relational statements.

Statistical conclusion validity Extent to which the conclu-

sions about relationships and differences drawn from statisti-

cal analyses reflect reality.

Statistical hypothesis, or null hypothesis (H0) Used for sta-

tistical testing and for interpreting statistical outcomes. Even if

the null hypothesis is not stated, it is implied, because it is the

converse of the research hypothesis.

Statistical significance Extent to which the results are prob-

ably not caused by chance.

Statistical techniques Analysis procedures used to examine,

reduce, and give meaning to the numerical data gathered in

a study.

Stetler Model of Research Utilization to Facilitate Evidence-

Based Practice An initial model for research utilization in

nursing to promote evidence-based practice for nursing; pro-

vides a comprehensive framework to enhance the use of

research evidence by nurses to facilitate an EBP.

Stratified random sampling Technique used when the

researcher knows some of the variables in the population

that are critical to achieving representativeness; the sample

is divided into strata or groups using these identified

variables.

Structural variables Factors such as the organization of nurs-

ing care and nursing leadership that have effects on nursing

practice and, in turn, on patient outcomes.

Structured interview Interview in which strategies are used

that give the researcher increasing control over the content.

An example is a questionnaire with structured responses.

Structured observational measurement Clear identifica-

tion of what is to be observed; precise definition of how the

observations are to be made, recorded, and coded.

Structure in outcomes Includes three subcomponents—

nurse, organization, and patient.

Structures of care The elements of organization and adminis-

tration that guide the processes of care.

512 Glossary

Study validity A measure of the truth or accuracy of the find-

ings obtained from a study. The validity of a study’s design is

central to obtaining quality results and findings from a study

Subjects Individuals participating in a study (those being

studied), who are sometimes referred to as participants.

Substantive theory Theory recognized within a discipline as

being useful for explaining important phenomena.

Symbolic interaction theory Explores how people define

reality and how their beliefs are related to their actions.

Symmetrical Term used to describe the normal curve, in which

both sides of the curve are mirror images of each other.

Synthesis Clustering and interrelating ideas from several

sources to form a gestalt or a new, complete picture of what

is known and not known in an area.

Systematic bias See Systematic variation.

Systematic measurement error Measurement error that is

not random but occurs consistently in the same direction, such

as a scale that inaccurately weighs subjects as being 3 pounds

heavier than their actual weight.

Systematic review Structured, comprehensive synthesis of

quantitative and outcomes studies in a particular healthcare

area to determine the best research evidence available for

expert clinicians to use to promote evidence-based practice.

Systematic sampling Selecting every kth (value determined

by the researcher) individual from an ordered list of all mem-

bers of a population, using a randomly selected starting point.

Systematic variation Phenomenon that occurs when the

selected subject’s measurement values vary in some way from

those of the population.

T

Target population Population determined by the sampling

criteria.

Tentative theory Theory that is newly proposed, has had min-

imal exposure to critique by scholars in the discipline, and has

undergone little testing.

Testable hypothesis Hypothesis containing variables that can

be measured or manipulated in the real world.

Test-retest reliability Determination of the stability or consis-

tency of a measurement technique by correlating the scores

obtained from repeated measures.

Textbook Book regarded as standard for the study of a partic-

ular subject.

Theoretical literature Concept analyses, maps, theories, and

conceptual frameworks that support a selected research prob-

lem and purpose.

Theoretical sampling Sampling in which data are gathered

from any individual study participant or group that can pro-

vide relevant information for theory generation.

Theory Integrated set of defined concepts, existence state-

ments, and relational statements that present a view of a phe-

nomenon; can be used to describe, explain, predict, and

control that phenomenon.

Therapeutic research Research that provides a patient with an

opportunity to receive an experimental treatment that might

have beneficial results.

Thesis Research project completed by a graduate student as

part of the requirements for a master’s degree.

Threats to design validity Possible problems in a study’s

design that are organized into four categories—statistical con-

clusion validity, internal validity, construct validity, and exter-

nal validity.

Time lag bias of studies Time span between the generation of

new knowledge through research and the use of this knowledge

in practice.

Total variance The combination of the within-group variance

and between-group variance determined when conducting an

analysis of variance statistical technique.

Traditions Truths or beliefs based on customs and past trends.

Transcription Written record created from an audio recording.

Transferable Used to describe qualitative findings as they are

applicable in other settings with similar participants.

Translational research Evolving concept defined by the NIH

as the translation of basic scientific discoveries into practical

applications.

Trial and error Approach with unknown outcomes used in an

uncertain situation when other sources of knowledge are

unavailable.

Triangulation Use of two or more theories, methods, data

sources, investigators, or analysis methods in a study.

True measure, or score Score that would be obtained if no

measurement error occurred (but there is always some mea-

surement error).

True-negative Negative test result that accurately indicates that

a disease is not present.

True-positive Positive test result that is an accurate identifica-

tion of the presence of a disease.

Trustworthiness Strength of a qualitative study determined by

evaluating all study aspects.

t-test Parametric analysis technique used to determine signifi-

cant differences between measures of two samples.

Two-tailed test of significance Analysis technique used for

a nondirectional hypothesis when the researcher assumes that

an extreme score can occur in either tail of the normal curve.

Type I error Error that occurs when the researcher concludes

that the samples tested are from different populations (a sig-

nificant difference exists between groups) when, in fact, the

samples are from the same population (no significant differ-

ence exists between groups); the null hypothesis is rejected

when it is true.

Type II error Error that occurs when the researcher concludes

that no significant difference exists between the samples exam-

ined when, in fact, a difference exists; the null hypothesis is

regarded as true when it is false.

Typical descriptive design Design used to examine and

describe variables in a single sample.

U

Unexpected results Study results indicating relationships

between variables or differences among groups that were not

hypothesized and not predicted from the framework being

used.

513Glossary

Unexplained variance Part of the variation between or among

two or more variables that is the result of things other than the

relationship.

Ungrouped frequency distribution Means of identifying and

displaying all numerical values obtained for a particular vari-

able from the subjects studied.

Unstructured interview Interview that is initiated with a

broad question; subjects usually are encouraged to elaborate

further on particular dimensions of a topic and often control

the content of the interview.

Unstructured observation Spontaneous observation and

recording of what is seen; planning is minimal.

V

Validity Extent to which an instrument accurately reflects the

abstract construct (or concept) being examined.

Variables Qualities, properties, or characteristics of persons,

things, or situations that change or vary and are manipulated

or measured in research.

Variance Measure of dispersion in which the larger the

variance, the larger the dispersion of scores. Variance is

calculated as one of the steps in determining standard

deviation.

Verification of information Occurs when researchers are able

to further confirm hunches, relationships, or theoretical

models.

Visual analog scale A 100-mm line, with right angle stops at

either end, on which subjects are asked to record their response

to a study variable.

Voluntary consent Decision made by a prospective subject, of

his or her own volition, without coercion or any undue influ-

ence, to participate in a study.

W

Within-group variance Source of variation that reflects the

individual scores in a group that vary from the group mean;

determined by conducting analysis of variance.

X

x-axis The horizontal scale of a scatterplot.

Y

y-axis The vertical scale of a scatterplot.

Z

Z-score Standardized score of the normal curve that is equiv-

alent to the standard deviation of the normal curve.

514 Glossary

I N D E X

Note: Page numbers followed by b indicate boxes, f indicate figures and t indicate tables.

A

AAALAC. see American Association for Accreditation of Laboratory Animal Care (AAALAC)

AACN. see American Association of Colleges of Nursing (AACN)

Abstracts critical appraisal of, 364 definition of, describing theories, 190 review of, to identify relevant studies,

179 section, in research reports, 51, 52b

Academic Center for Evidence-Based Nursing, website, 455

Academic Search Complete, as database for nursing literature reviews, 177t

Acceptance rates adequacy of, 255b of subjects, 253, 255b

Accessible population, 256f definition of, 250 representativeness, 252–257

Accidental sampling. see Convenience sampling

Accuracy of physiological measures, 289t, 292 and precision, in quantitative research,

36 Adaptation model, 195t Administration, and nursing research, 3 Administrative data, collection of, 311 Administrative databases, 483 Advanced beginner stage, of nursing

experience, 17 Advanced practice nurses (APNs)

safety and effectiveness of, 476, 477t types of, 476

Advanced practice nursing, in outcomes research, 476

Advances in Nursing Science, 9t, 12, 50t Adverse outcome, definition of, 472t African American women, blood pressure

in, 5, 6f Age, as demographic variable, 157–158 Agency for Healthcare Policy and

Research (AHCPR), on outcomes research, 9t, 13

Agency for Healthcare Research and Quality (AHRQ), 13, 143, 467, 473

developing evidence-based guidelines, 25

Agreement, data use, 106 AHCPR. see Agency for Healthcare Policy

and Research (AHCPR)

AHRQ. see Agency for Healthcare Research and Quality (AHRQ)

Algorithms, 456, 458f for identifying an appropriate analysis

technique, 338, 339f Alpha (a), 325 Alternate forms reliability, 289t, 290 American Association for Accreditation of

Laboratory Animal Care (AAALAC), 124

American Association of Colleges of Nursing (AACN), on nursing research, 14, 25–26

American Association of Critical Care Nurses, research priorities of, 142

American Journal of Nursing, history of, 11 American Nurses Association (ANA)

National Database of Nursing Quality Indicators, 475t

Nursing Care Report Card, 474 on nursing research, 9t, 11, 25–26

American Nurses Credentialing Center (ANCC)

and Magnet Recognition Program, 363 website, 478

American Psychological Association (APA)

citation formatting, 185t Publication Manual (2010), 184

American Recovery and Reinvestment Act, 473–474

ANA. see American Nurses Association (ANA)

Analysis of covariance (ANCOVA), 353 definition of, 353 uses for, 353

Analysis of data on outcome research, 491 in qualitative studies, 391 strengths and weaknesses of, 393

in quantitative studies, strengths and weaknesses of, 374

Analysis of variance (ANOVA), 351–352 definition of, 351 interpreting results of, 351–352 research example of, 351b

ANCC. see American Nurses Credentialing Center (ANCC)

Ancestry searches, 432 ANCOVA. see Analysis of covariance

(ANCOVA) Animals, ethics of research use of, 123–125 Annual Review of Nursing Research, 9t, 13 Anonymity, 106–107

ANOVA. see Analysis of variance (ANOVA)

Anthropology, and ethnographic research, 74

APA. see American Psychological Association (APA)

Applied Nursing Research, 50 Applied Nursing Research and Nursing

Science Quarterly, 12 Applied research, definition of, 35–36 Aquarobic exercise program, 230, 231t Articles, 166 keywords for selecting, 178 obtain full-text copies of, 179–180 reading of, 180

Assent form, sample, 103b Association of Women’s Health, Obstetric,

and Neonatal Nurse, website, 455 Associative hypotheses versus causal, 149–150 definition of, 149

Assumptions definition of

in quantitative research, 42 definition of conceptual model, 191

Authority, definition of, 16 Autonomous agents, definition of, 101 Autonomy, diminished, and informed

consent competence, 101–104

B

Bachelor of Science in Nursing (BSN), roles of, in nursing research, 26

Basic research, definition of, 35 Bathing, research concerning, 301b Beck Depression Inventory II, in

predictive correlational design, 220b

Behavioral research, ethical conduct in, 98 Belmont Report, 98 Beneficence, principle of, 98, 108 Benefit-risk ratios research example of, 121b of a study, 119–121, 119f

definition of, 119–120 Best research evidence, 3–4, 21–22, 415,

461 Between-group variance, 351 Bias definition of, 223 protection against, 212–213 in research design, 223

Bibliographic databases, 177 Bimodal distribution, 331–333, 333f

515

Biological Research for Nursing, 9t, 13 Biomedical research, ethical conduct in, 98 Bivariate correlation, 340–341 Blinding, 241 Blood pressure

in African American women, 5, 6f classification of, with nursing

interventions, 4–5, 5t as physiological measure, 292 theoretical basis for effects of

telemonitoring on, 57f Bonferroni procedure, 349, 351 Borrowing, in nursing, 16 Bracket, 69 Breach of confidentiality, 107 BSN. see Bachelor of Science in Nursing

(BSN)

C

Cancer, unethical research in, at Jewish Chronic Disease Hospital, 97–98

CANCERLIT, evidence-based practice resource, 420t

Cardiovascular diseases, and smoking risk, 4–5

Care evaluating outcomes of, 477–478 evaluating process of, 480–481 evaluating structure of, 478–480, 479t standards of, 480

Case studies, definition of, 11 Causal hypotheses

versus associative, 149–150 definition of, 149–150

Causality definition of, 222 elements of design examining, 229–232 in research design, 222–224 testing

in experimental designs, 212, 237, 238f

in quasi-experimental designs, 212, 222

using statistics to examine, 347 Center for Epidemiologic Studies

Depression Scale (CES-D), 287–288, 288f

Centers for Health Evidence, website, 455 CES-D. see Center for Epidemiologic

Studies Depression Scale (CES-D) CFR. see Code of Federal Regulations

(CFR) Chi-square test of independence,

347–348 interpreting results of, 347–348 research example of, 348b

Children assent form for, 103b ethical conduct of research with,

102–103 informed consent for, 103t legal issues concerning, 102

CI. see Confidence interval (CI) CINAHL. see Cumulative Index to

Nursing and Allied Health Literature (CINAHL)

Citation, 165–166, 185t bias, 433 of sources, purpose of, 180

Clinical and Translational Science Awards (CTSA), consortium, 461

Clinical databases, 483 Clinical decision trees, 456 Clinical expertise, 4 Clinical importance, statistical, 355 Clinical journals, 166

providing important sources of research reports, 50t

Clinical Nursing Research, 13, 50 Clinical research, history of, 11, 12 Cluster sampling, as probability sampling

method, 258t, 261, 262b CNCF. see Cochrane Nursing Care Field

(CNCF) Cochrane Collaboration, 9t Cochrane Library

evidence-based practice resource, 420t source for evidence-based guidelines, 25

Cochrane Nursing Care Field (CNCF), 419

evidence-based practice resource, 420t

Code of Federal Regulations (CFR), 99 Codes, in qualitative research, 89 Coding, method of, 89 Coefficient of multiple determination,

345 Coercion, 101 Cognitive impairments, competency

issues with, 104 Collection, of data

in qualitative studies, 391 strengths and weaknesses

of, 393 in quantitative studies, strengths and

weaknesses of, 374 Comfort

definition of, 195–196 theory of, 196–197, 197f

Comparative descriptive design definition of, 216 diagram illustrating, 216f research example, 217b

Comparison group. see Control groups Competent stage, of nursing

experience, 17 Complete reviews, by institutional review

boards, 118 Complex hypotheses

definition of, 150 versus simple hypotheses, 150

Comprehension, of consent information, 112

Computation, in statistical analysis process, 324

Computer-assisted qualitative data analysis software (CAQDAS), in qualitative research, 88

Computer programs, for qualitative research, 88

Concepts as basic element of theory, 191–192,

192f definition of, 190 in physiological studies, 205 related to Orem’s self-care deficit

theory, 201t Conceptual definitions, 193t bias protection and, 212–213 description of, 192 middle range theory with, 203t of study variables, 44, 44b of variables

in quantitative research, 155, 158 in quasi-experimental study, 56b

Conceptual frameworks, of theories, 194 Conceptual maps, in literature review,

182t Conceptual models, definition of, 194.

see also Grand nursing theories Conclusions in literature review, 184 in reasoning, 18 from statistical outcomes, 355

Concrete, 190–191 Conduct and Utilization of Research in

Nursing (CURN), 9t, 12 Conference proceedings, 166 Confidence interval (CI), 334 Confidentiality, 106–107 breach of, 107 definition of, 106–107 rights to, 106–107

Confirmability, 392 Confounding variables, 154, 471 Connotative definitions, 192 Consent. see also Informed consent from study participants, 47

Consent documents formal written, 114–115 short form, 114

Consent form, 112, 113f Consent process, Nuremberg code and,

95–96 Consistency, in data collection, 310 CONsolidated Standards for Reporting

Trials (CONSORT), 241, 242f CONSORT. see CONsolidated

Standards for Reporting Trials (CONSORT)

Construct validity, 291 Constructs defining in theory, 191, 192f inadequate definitions of, 228 related to Orem’s self-care deficit

theory, 201t validity, 225t, 227–228

Content validity, 289t, 291

516 Index

Control nursing research definition of, 8 in quantitative research, 36–37, 37t in research design, 224 in study design, 311

Control groups, 230 in experimental research, 34

Convenience sampling, as nonprobability sampling method, 258t, 264, 264b

Correlation coefficient from Pearson correlation analysis

results, 341 significance of, testing of, 342, 342b

Correlational analysis, to examine relationships, 340–341

Correlational designs algorithm for determining type

of, 218f descriptive, 218–219 model testing, 221, 221b, 222f predictive, 220, 220b, 220f purpose of, 215b, 217

Correlational research control in, 37t definition of, 33–34 example of, 133t introduction of, 20, 20b Pearson, Karl on, 33 purpose of, 136

Costs of health care, 14, 21 of research studies, 144

Covered entities, 105 Covert data collection, 101 Credibility, 392

evaluation of, in quantitative studies, 374–375

Critical appraisal, 362 of an abstract, 364 intellectual, 362, 365, 410

of qualitative studies, 365–366 of quantitative studies, 365–366

key principles for, 365–366, 365b of outcomes studies, 492–493

example, 493, 493b questions guiding, 492–493

process of in qualitative research, 389–394 in quantitative research, 366–375

of qualitative research, 361–413 of qualitative study, 389, 394–409,

395b, 410 of quantitative research, 361–413 of quantitative study, 375–388, 376b,

381f, 385f, 386f of research, 27 steps of, 363 of studies implemented in nursing,

362–365 following presentation and publication, 364

Critical appraisal (Continued) by practicing nurses, nurse educators,

and researchers, 363–364 for presentation and publication, 364 research proposals, 364–365 by students, 363

Critical appraisal guidelines for adequacy of sample, in quantitative

studies, 255b, 268b for data collection, 312b for diagnostic test, 296b for ethical aspects of a study, 120–121,

120b for framework of a study, 199b for human rights protection, 109–110,

110b for hypotheses in studies, 151b for inferential statistical analyses,

338–339 on informed consent process, 115–116,

115b for interpreting statistical outcomes, 356b for interviews, 303b for literature reviews, 168b for measurement error, 293b for observational measurement, 300b for questionnaires, 305b for reliability and validity, 293b for research objectives and questions,

146b for research problems and purposes,

131b sample, description of, 320b for sample adequacy, in qualitative

studies, 275b for scales, 309b for screening test, 296b for specificity and sensitivity, 296b for study’s problem and purpose

feasibility, 144b for variables, 155b

Critically appraising literature reviews, 168–175, 168b

Critique, 362 Cronbach alpha coefficient, 323 Cross-sectional design, 212 CTSA. see Clinical and Translational

Science Awards (CTSA) Culture, ethnographic research and, 74, 82 Cumulative Index to Nursing and Allied

Health Literature (CINAHL) as database for nursing literature

reviews, 177t evidence-based practice resource, 420t

CURN. see Conduct and Utilization of Research in Nursing (CURN)

Current sources, definition of, 167

D

Data. see also Data collection analysis, 88–89 collection in qualitative research, 82–87

Data (Continued) management in qualitative research, 88 missing, management of, 320 obtaining, 311–312

Data analysis example of, 90b in qualitative research, 88–89, 89b in qualitative studies, 391

strengths and weaknesses of, 393 in quantitative research, 47–48, 63 in quantitative studies, strengths and

weaknesses of, 374 techniques, 268–269

Data-based literature, in literature review, 167

Data collection, 63 consistency, 310 control in, 311 critical appraisal guidelines for, 312b in historical research, 83 measurements and, in quantitative

research, 281–316 accuracy, precision and error of physiological measures, 292–294, 293b

measurement theory concepts, 283–292

nursing measurement strategies, 298–309

process of, 310–312 measurements strategies and

interviews, 302–303 observational measurement, 300–301

physiological measures, 298–299 questionnaires, 304–305 scales, 306–309

methods in qualitative research, 82–87 biography construction, 83 focus groups, 85, 85b interviews, 83–84, 84b observation, 86, 87b text as source, 87

in problem-solving, nursing process and research process, 39t

process of, 310–312 in qualitative studies, 391

strengths and weaknesses of, 393 in quantitative research, 47 in quantitative studies, strengths and

weaknesses of, 374 recruitment of study participants, 310 research example of, 312b

Data files, organizing, 88 Data use agreement, 106 Databases clinical, 483 existing, obtaining data from, 311–312 large, as sample sources, 483, 483f, 484t search fields, 178 searching and selecting of, 178 used for nursing literature reviews, 177t written search records of, 178t

517Index

Deception, self-determination and, 101 Decision theory, 325–326 Decision tree, for identifying an

appropriate analysis technique, 338, 339f

Decision making, in Stetler Model of Research Utilization to Facilitate Evidence-Based Practice, 447f, 448–449

Decision-making model, of self-care and organization of work, 43f

Declaration of Helsinki, 96–97 Deductive reasoning, definition and

example of, 18 Degrees of freedom (df), 329–330 De-identification, of protected health

information, 106 Demographic variables, 157–158, 320 Department of Health, Education, and

Welfare (DHEW), on human research subject protection, 98

Department of Health and Human Services (DHHS)

description of, 14 guidelines for IIHI, 105 HIPAA Privacy Rule and, 99, 100t on informed consent, 111 Protection of Human Subjects

Regulations, 99, 100t Dependability, 392 Dependent groups, 338 Dependent variables, 153

in predictive correlational design, 220, 220f

in quasi-experimental research, 233f, 234f, 235f, 236b, 239f

Description, nursing research definition of, 6

Descriptive correlational designs, 218–219, 218f, 219b

Descriptive designs algorithm for determining type of, 214f comparative, 216, 216f definition of, 212–213, 215b diagram of typical, 215f in nursing studies, 212 research example, 215b

Descriptive research control in, 37t definition of, 33 examples of, 133t introduction of, 20, 20b problems and purposes of, 133

Descriptive statistics, 319 research example of, 336b

Designs algorithm for determining type of, 213f comparative descriptive, 216 concepts important to, 222–224

bias, 223 causality, 222 control, 224 manipulation, 224

Designs (Continued) multicausality, 223 probability, 223

correlational, 215b, 217–221 definition of, 36, 211 descriptive, 212–216 descriptive correlational, 218–219, 218f model testing, 221, 221b, 222f predictive correlational, 220, 220b, 220f for quantitative study, 211 important design concepts, 222–224 nursing studies, 212

randomized controlled trials, 241–242 strengths and weaknesses of, in

quantitative studies, 372 of study, 45

DHEW. see Department of Health, Education, and Welfare (DHEW)

DHHS. see Department of Health and Human Services (DHHS)

Diagnosis, as demographic variable, 157–158

Diagnostic tests likelihood ratios, 298 quality determination of, 295–298 sensitivity of, 295–297, 296b, 296t specificity of, 295–297, 296b, 296t

Diet, Florence Nightingale’s work on, 11 Digital object identifiers (DOIs), 184 Diminished autonomy, 101–104 Direct measures, 283 Direct recall, in retrospective cohort study,

486 Directional hypotheses

definition of, 150 versus nondirectional, 150

Discharge Abstract Database (DAD), 473 Discomfort and harm

categories of, 108 right to protection from, 108–109

Discussion section, of research reports, 51b, 54, 164

Dispersion, measures of, 333–336 Dissertation, 166 Distal outcome, 478 Doctorate degree, roles of, in nursing

research, 27 Documentation

of database searches, 178, 178t of informed consent, 113–115

DOIs. see Digital object identifiers (DOIs) Donabedian, Avedis, 468 Donabedian’s Theory of Quality Health

Care assessment of, 468, 468f defining quality, 468, 468f evaluating process, 469 levels of quality, 469f nursing-sensitive outcomes, 469–471 in outcomes research, 468–469, 468f

Dunnett’s test, 351 Duplicate publication bias, 433 Dwelling, with data, 88–89

E

Ease, in comfort, 196–197 EBP. see Evidence-based practice (EBP) EBSCOhost, 178 Economic studies, 488 Education as demographic variable, 157–158 history of nursing, 9t, 11 nursing, 26

Effect sizes, 433–434 definition of, 267

in statistics, 329 EHRs. see Electronic health records (EHRs) Electronic database, for literature review,

178 Electronic health records (EHRs), 419 Electronic Self-Management Resource

Training for Mental Health (eSMART-MH), 36

Elements, definition of population, 250, 250f

Eligibility criteria, in sampling theory, 251 Emic approach, to anthropological

research, 74 Emotional support, 191 Empirical knowledge, 4–5, 6, 12 Empirical literature, 167 discussion of, 183

Encyclopedia, 166 EndNotes, 178 Environmental variables, 154–155 EPCs. see Evidence-based practice centers

(EPCs) Equipments, availability of, 144–145 Equivalence, reliability testing, 290 eSMART-MH. see Electronic Self-

Management Resource Training for Mental Health (eSMART-MH)

Ethical codes and regulations, historical events influencing, 95–100

Ethical issues concerning research with children,

102–103 concerning research with neonates, 102

Ethical principle of justice, right to fair selection and

treatment and, 107 relevant to the conduct of research

involving human subjects, 98 Ethical studies, 488 Ethics, in nursing research, 93–128 Ethnic origins, as demographic variable,

157–158 Ethnographic research example of, 75b, 137t intended outcome of, 75 introduction of, 21 problems and purposes of, 139–140 in qualitative research, 74–75 researcher-participant relationships

in, 82 review of literature in, 165

518 Index

Ethnography, definition of, 74 Ethnonursing research, description of, 74 Etic approach, to anthropological

research, 74 Evaluations

in appraising quality, 469 in problem-solving, nursing process

and research process, 39t Evidence-based guidelines

definition of, 25 development of, 25 history of the development of, 454 implementing, 453–460, 457f, 458f websites, 25

Evidence-based practice centers (EPCs), 462

introduction to, 460 Evidence-based practice (EBP), 1–30, 4f,

414–465, 481 barriers to, 418–419 benefits to, 416–418, 462 best research evidence and, 3–4 blood pressure

in African American women, 5, 6f classification of with nursing interventions for, 4–5, 5t

clinical expertise, 4 definition of, 415, 461 as goal for nursing, 6 guidelines, 9t, 25, 177.

see also Evidence-based guidelines JNC 7 implementation in, 4–5 models to promote, in nursing,

447–453 quality care, 417–418 searching sources, 419–420, 420t

Evidence-based sources, 419–420, 420t Exclusion sampling criteria, 251 Exempt from review, 117–118 Expedited review, 118 Experience, personal, 17 Experiment, features of, 32 Experimental designs

algorithm for determining type of, 238f

definition of, 234b, 237 illustration of classical, 239f pretest and post-test, 237–239, 239f

Experimental group, 230 Experimental research, 136

control in, 37t essential elements of, 246 example of, 133t introduction of, 20b, 21 practice reading, 55–62 purpose of, 34, 60–62 steps of research process in, 60b

Experimental variables, 153 Experimenter expectancies, 228 Expert stage, of nursing experience, 17 Explained variances, 341 Explanation, nursing research definition

of, 7

Exploratory analyses, 323 Exploratory-descriptive qualitative

research, 76–77, 77b, 140 examples of, 137t intended outcome of, 77 philosophical orientation of, 77

Exploratory-descriptive qualitative researchers, 165

External validity, 225t, 228–229 Extraneous variables, 154–155

in quantitative research, 37 Extraneous variances, in study setting, 226

F

Fabrication, in research, 122 Facilitator. see also Moderator

in focus groups, 85 Facilities, availability of, 144–145 Factor analysis, 343–344 Factors, 343 Fair selection, right to, 107–108 Fair treatment, right to, 107–108 False negative, 295, 296t False positive, 295, 296t Falsification, of research, 122 FDA. see Food and Drug Administration,

US (FDA) Feasibility, of a problem and purpose,

143–145 critical appraisal guidelines for, 144b ethical considerations in, 145

Federal government involvement, in outcomes research, 473–476

Federal regulations, for protection of human subjects, 99–100, 100t

Fetuses ethical laws concerning, 104 legal issues concerning, 104

Field setting, 38, 277, 277b Financial outcomes, areas of outcomes

research, 21 Findings, statistical, 354

exploring significance of, 354–355 Fisher, Ronald, 33 Focus groups, 85, 85b Focused ethnography, 74 Food and Drug Administration, US (FDA)

informed consent and, 111 institutional review boards (IRBs) and,

117 onprotection of human subjects, 99, 100t

Forest plot, 436, 437f Forging. see Plagiarism Frameworks, 198–199

based on middle range theory, 202–203, 202b, 203f, 203t

critical appraisal guidelines for, 199b examples of, 199–206

implicit, 198 for physiological study, 205–206, 205b,

206f in qualitative research, 71

Frameworks (Continued) in quantitative studies

section of, 164 strengths and weaknesses of, 371

study, in quantitative research process, 42

from tentative theory, 204, 204b understanding theory and research,

189–209 Fraudulent studies, in research, 122 Frequency distribution, 330–331 Full-textarticles,electronicfileof,179–180 Functional maintenance, areas of

outcomes research, 21 Functional Social Support Questionnaire,

191 Functional status, definition of, 472t Funnel plots, 433–434, 434f

G

Gender, as demographic variable, 157–158 General propositions, within theories,

193–194, 194t Generalization definition of, 48 in sampling theory, 250–251 in statistical analyses process, 326 of statistical findings, 356

Goals, of research studies, 41 Going native, in ethnographic research,

74–75 Gold standard, 295 Grand nursing theories, 194–195, 195t

framework from, 199–201, 200b Grey literature, 424–425 Grounded theory research definition of, 70–73 development of, 70–71 example of, 72b, 73f, 137t intended outcome of, 71–73, 71t introduction of, 21 literature review purpose in, 164–165 problems and purposes of, 139 using theoretical sampling, 273

Grouped frequency distribution, 330–331, 331t

Groups, grounded theory research and, 70–71

Grove Model for Implementing Evidence- Based Guidelines in Practice, 456–459, 459f, 462

Guidelines Advisory Committee, website, 455

Guidelines International Network, website, 455

H

Harm, discomfort and, right to protection from, 108–109

Harvard Nurses’ Health Study, 485 Health Behavior Scale, in predictive

correlational design, 220b

519Index

Health care costs. see Costs Health information, disclosure

authorization, 115 Health Insurance Portability and

Accountability Act (HIPAA) clarification of, 99, 100t development of, 99 Privacy Rule, 99, 100t

authorization for research uses and disclosure, 115

influence on institutional review boards, 118–119

Health-seeking behaviors, 196–197 Health Source: Nursing/Academic

Edition, as database for nursing literature reviews, 177t

Healthcare services, nursing research and, 3

Healthcare utilization, definition of, 472t Healthy People 2000, 9t, 14 Healthy People 2010, 9t, 14 Healthy People 2020, 9t, 143

website of, 143 Heart rate, as physiological measure, 292 Heidegger’s philosophy,

phenomenological research and, 69

HerbMed, Evidence-Based Herbal Database, website, 456

Hermeneutics, description of, 69–70 Heterogeneity, in meta-analysis, 430–431 Heterogeneous samples, 251 Highly controlled settings, 38, 278, 278b Highly sensitive test, 296 Highly specific test, 296 Hinshaw, Dr. Ada Sue, 13 HIPAA. see Health Insurance Portability

and Accountability Act (HIPAA) Historical research

classification of, 20b definition of, 78–80

in qualitative research, 137t examples of, 79b, 81f intended outcome of, 79–80 introduction of, 21 literature review purpose in, 165 problems and purposes of, 140 sources for, 79, 79b

History in examining validity of studies, 227 influencing ethical codes and

regulations development, 95–100

of nursing research, 11–12 philosophical orientation of, 78–79 and treatment, interaction of, 229

Ho. see Null hypothesis (H0) Homogeneity, 289t, 290 Homogeneous samples, 251 HSD. see Tukey’s honestly significantly

difference (HSD) test Human behavior, in phenomenological

research, 69

Human rights definition of, 100–101 protecting, 100–110 critical appraisal guidelines for,

109–110, 110b research example of, 110b

Human subjects. see Subjects Husserl’s philosophy, 69 Hypotheses, 149–153

associative versus causal, 149–150 critical appraisal guidelines for,

151b definition of, 43–44 development of, from descriptive

designs, 214 Fisher, Ronald on, 33 key concepts, 158 nondirectional versus directional, 150 research example of, 151b simple versus complex, 150 statistical versus research, 151 testable, 152–153 within theories, 193–194 types of, 149–151

Hypothesis testing, 325–326

I

IIHI. see Individually identifiable health information (IIHI)

Immersion, in ethnographic research, 74–75

Implementation in problem-solving, nursing process

and research process, 39t steps of nursing process, 38–39, 39t

Implications for nursing, in scientific research, 356

Implicit framework, 198 Inclusion sampling criteria, in sampling

theory, 251 Income, as demographic variable,

157–158 Inconclusive results, 353–354 Independent groups, 338 Independent variables, 153

in predictive correlational designs, 220, 220f

in quantitative research, 36–37 in quasi-experimental research, 212,

233f, 234f, 239f Indicators

for measurement of nursing-sensitive outcomes in acute care hospitals, 474

of measurement theory concepts, 283–284

Indirect measures, of concepts, 283–284

Indirect recall, in retrospective cohort study, 486

Individually identifiable health information (IIHI), definition of, 105

Inductive reasoning, definition and example of, 18

Inference, in statistical analyses process, 326

Inferential statistical analyses, 323 critical appraisal guidelines for,

338–339, 340b Inferential statistics, 319 to examine differences, 347–353 in studies, determining the

appropriateness of, 337–339, 339f Information, quality of, in qualitative

study, 275 Informed consent, 111–116 critical appraisal guidelines for,

115–116, 115b documentation of, 113–115 four elements, 111

competence, 112 comprehension, 112 essential information, 111–112 voluntary consent, 113

research example of, 116b waiving of, 114

Institutional review, 117–119 definition of, 117 influence of HIPAA Privacy Rule on,

118–119 levels of, 117–118 research exempted from, 117–118

Institutional review boards (IRBs), 117 to examine ethical aspects of studies,

94–95 influence of HIPAA Privacy Rule on,

118–119 levels of review, 117–118

Institutions, persons confined to, 104 Integrative reviews, of research, definition

of, 23–24 Intellectual critical appraisal, 362, 365, 410 of qualitative and quantitative studies,

365–366 Interlibrary loan system, 179–180 Internal consistency, 290 Internal validity, 225t, 226–227 International Journal of Nursing Studies,

11–12 Interpretations of analysis of variance (ANOVA),

351–352 of chi-square test of independence,

347–348 of qualitative research, 89, 89b, 90b of statistical outcomes, 353–357

conclusion, 355 critical appraisal guidelines for, 356b findings, 354 generalization of findings, 356 implications, 356 limitations, 355 recommendations for further studies, 356–357

of t-test, 349–350

520 Index

Interrater reliability, 289t, 290 Interval-level measurement, 285–286 Interval scales, measurement, definition

of, 285–286 Intervention fidelity, 230 Intervention reliability, 226 Interventions

examining, in nursing studies, 230 in quasi-experimental research, 56b in research designs, 230 study, definition of, 38

Interviews, 302–303 critical appraisal guidelines for, 303b in qualitative research, 83–84, 84b research example of, 303b transcribing, 88

Intraproject sampling, 274 Introduction section

in literature review, 183, 186 of research reports, 51b, 52–53

Intuition, definition of, 18 Invasion of privacy, 105 Iowa Model of Evidence-Based Practice,

450, 451f, 452t, 462 application of, 450–453

IRBs. see Institutional review boards (IRBs)

J

JBI. see Joanna Briggs Institute (JBI) Jewish Chronic Disease Hospital Study,

97–98, 107 JNC 7. see Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)

Joanna Briggs Institute (JBI), evidence- based practice resource, 420t

Job classification, as demographic variable, 157–158

Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7), implementation of, 4–5

Journal of Nursing Measurement, 9t, 13 Journal of Nursing Scholarship, 9t,

12, 50t Journal of the American Medical

Association, 456 Journals

clinical, 166 numbering of volumes of, 184 referred, 364 research and clinical, 50t

Judgmental sampling, 270 Justice, principle of, 98

K

Key informants, in qualitative research, 82 Keywords, definition of, 178 Knowledge

acquiring, 15–18 through nursing research, 19–21

Knowledge (Continued) authority and, 16 definition of, 15 historical research and, 78 literature review, 163

L

Laboratory animals, humane care and use of, 124

Landmark studies, definition of, 167 Language bias, 433 Leininger, Madeline, on visibility of

ethnography, 74 Leininger’s Theory of Transcultural

Nursing, 74 Level of significance, 325–326.

see also Alpha (a) normal curve and, 326–327

Librarian/course faculty member, 176–177, 186

Likelihood ratios (LRs), 298 Likert scale, 307–308 Limitations

definition of, 48 in statistical outcomes interpretation,

355 Limited recall, in retrospective cohort

study, 486 Line of best fit, 344, 345f Literature, 165–166

appraise, analyze, and synthesize, 180–183

empirical, 167 summary table of, 181, 186 example of, for studies, 181t for qualitative studies, 182t for quantitative studies, 182t

Literature reviews, 176–185 checking of, 185 checklist, steps of, 176b, 186 critically appraising, 168–175, 168b in qualitative study, 172–175, 173b in quantitative study, 168–171, 169b

electronic databases and search terms for, 177–178, 177t

organize information from, 183–184 preparing to, 176–178 clarify the purpose of, 176–177 conducting, 178–180, 178t, 179t processing, 180–183, 181t, 182t select electronic databases and search

terms, 186 writing, 183–185, 185t

in published research, 163 purpose of, 163–165 in qualitative research, 164–165 in quantitative research, 163–164

quality of sources, 167 in quantitative studies, 367 strengths and weaknesses of, 371

search fields, 178 sources included in, 165–167

Literature reviews (Continued) understanding and critically appraising,

162–188 Location bias of studies, 433 Logical positivism, 19–20 Longitudinal design, 212 Low statistical power, in examining

validity of studies, 226 LRs. see Likelihood ratios (LRs)

M

Magnet Recognition Program, 363 Manipulation, 224 Mapping, manipulation and, 181 Maps, research framework, 198 Marital status, as demographic variable,

157–158 Master of Science in Nursing (MSN), roles

of, in nursing research, 26–27 Maturation, in examining validity of

studies, 227 MD Consult, website, 456 Mead, George Herbert, on symbolic

interaction theory, 70–71 Mean, 330t definition of, 333 difference, 435 in measures of central tendency, 333

Measurement theory, concepts of, 283–292

directness of measurement, 283–284, 284f

error, 286–287 levels of, 284–286, 285f reliability, 287–290, 293b validity, 290–292, 293b

Measurements data collection and, in quantitative

research, 281–316 accuracy, precision and error of physiological measures, 292–294

measurement theory concepts, 283–292

nursing measurement strategies, 298–309

process of, 310–312 definition of, 282 directness of, 283–284, 284f, 293b error, 286–287

critical appraisal guidelines for, 293b interval-level, 285–286 levels of, 284–286, 285f, 293b methods of

in outcomes research, 488–491, 489t

in quantitative research, 46, 63 reliability or precision of, 226

nominal-level, 284 ordinal-level, 284–285 purpose of, 287 ratio-level, 286 reliability, 287–290

521Index

Measurements (Continued) sensitivity, 268 strategies in nursing, 298–309

interviews, 302–303 observational measurement, 300–301

physiological measures, 298–299 questionnaires, 304–305 scales, 306–309

strengths and weaknesses of, in quantitative studies, 373

validity, 290–292 Measures of central tendency, 327f,

331–333 mean, 330t, 333 median, 333 mode, 331–333

Measures of dispersion, 333–336 Median

definition of, 333 in measures of central tendency, 333

MEDLINE as database for nursing literature

reviews, 177t evidence-based practice resource, 420t

with MeSH, 420t Mental illness

competency issues with, 104 legal issues concerning, 104

Mentorship, 17–18 Meta-analyses

clinical question for, 432 critically appraising, 421t, 430–436 definition of, 430–431, 462 possible biases for, 433–434 purpose of, 432 questions to direct, 432 recommended reporting for authors to

facilitate, 431b of research literature, 22, 23t results of

for continuous outcomes, 435 for dichotomous outcomes, 435–436

search criteria/strategies for, 432–433 Meta-syntheses

analysis of data, 439–440 appraisal of studies, 439–440 critically appraising, 436–440, 438b definition of, 437–438, 462 discussion of findings, 440 framing for, 438 overall findings of, 441f of qualitative research, 23, 23t searching literature in, 439 selecting sources in, 439

Metasummaries, 437–438 Methodological bias, 433 Methodological limitations, 355 Methods section

of research article, 145 of research reports, 51b, 53, 164

Middle range theories, 196t definition of, 195–196

Middle range theories (Continued) framework based on, 202–203, 203f,

203t research example of, 202b

Minimal risks, definition of, 118 Minors, with legal and mental diminished

autonomy, 101–102 MIS. see Standards for Management

Information Systems (MIS) Misconduct. see Research misconduct Missing data, management of, 320 Mixed-method

approaches, 243–244, 244b systematic reviews, 23–24, 23t critically appraising, 440–443,

442b definition of, 441

Mixed results, 354 Mode

definition of, 331–333 in measures of central tendency,

331–333 Model testing designs

definition of, 221 diagrams illustrating, 222f research example, 221b

Models, research framework, 198 Moderator, in focus groups, 85 Modification, in problem-solving,

nursing process and research process, 39t

Money. see Costs Mono-operation bias, 228 Monographs, definition of, 166 Morbidity data, gathered by Florence

Nightingale, 11 Mortality data, gathered by Florence

Nightingale, 11 Mortality rate, definition of, 472t MSN. see Master of Science in Nursing

(MSN) Multicausality, 223 Multilevel synthesis, 441 Multiple groups, in experimental designs,

237–239 Multiple regression, 344

N

NANDA. see North American Nursing Diagnosis Association (NANDA)

National Association of Neonatal Nurses source for evidence-based guidelines, 25 website, 456

National Center for Nursing Research (NCNR), 9t, 13

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 98–99

National Database of Nursing Quality Indicators (NDNQI), 474–476, 475t

National Guideline Clearinghouse (NGC), 454–456

of Agency for Healthcare Research and Quality (AHRQ), 454–455

evidence-based practice resource, 420t Guideline Syntheses, 455 source for evidence-based guidelines, 25

National Human Genome Research Institute, 35

National Institute for Clinical Excellence (NICE)

evidence-based practice resource, 420t website, 456

National Institute of Nursing Research (NINR)

addressing nursing research priorities, 142–143

history of, 9t, 13 mission of, 14–15

National Library of Health (NLH), evidence-based practice resource, 420t

National Quality Forum (NQF), 474 National Research Act, 98 Natural settings, 38, 277, 277b Nazi medical experiments, 95, 107, 109 NCNR. see National Center for Nursing

Research (NCNR) NDNQI (National Database of Nursing

Quality Indicators), 474–476 Negative likelihood ratio, 298 Negative relationships, in Pearson

correlation analysis, 341 Neonates definition of, 102 ethical conduct of research with, 102 legal issues concerning, 102 viable versus nonviable, 102

Network sampling, 271–272, 272b Newman-Keuls’ test, 351 NGC. see National Guideline

Clearinghouse (NGC) NICE. see National Institute for Clinical

Excellence (NICE) Nightingale, Florence, role in nursing

research, 9t, 11 NINR. see National Institute of Nursing

Research (NINR) NLH. see National Library ofHealth (NLH) No recall, in in retrospective cohort study,

486 Nominal-level measurement, 284 categories of, 284

Nondirectional hypotheses definition of, 150 versus directional, 150

Nonexperimental designs, 212 Nonparametric analyses, 338 Nonprobability sampling methods convenience sampling, 258t, 264, 264b network/snowball sampling, 258t versus probability sampling methods,

258t

522 Index

Nonprobability sampling methods (Continued)

purposeful sampling, 258t quota sampling, 258t, 265, 265b theoretical sampling, 258t

Nonsignificant results, 353–354 Nontherapeutic research, 96

benefit-risk ratio in, 120 guide to informed consent, for children,

103t versus therapeutic research, 103t

Normal curves, 326–327, 327f North American Nursing Diagnosis

Association (NANDA), 12 Novice stage, of nursing experience, 17 NQF. see National Quality Forum (NQF) NRC. see Nursing Reference Center

(NRC) NRS. see Numeric Rating Scale (NRS) NSPO. see Nursing-sensitive patient

outcome (NSPO) Null hypothesis (H0)

definition of, 151 versus research hypothesis, 151

Numeric Rating Scale (NRS), 307f Nuremberg code, 95–96, 96b Nurse educators, critical appraisal of

studies by, 363–364 Nurses

characteristics and roles of, nursing research and, 3

critical appraisal of studies by, 363–364 importance of nursing research to, 3 role of, in outcomes, 469–471

Nursing critical appraisal of

qualitative research for, 361–413 quantitative research for, 361–413

education, 3 educational degree levels of, 25–26, 26f ethnography and, 74 grounded theory research example, 72b knowledge. see Knowledge levels of experience, 17 measurement strategies in, 298–309

interviews, 302–303 observational measurement, 300–301 physiological measures, 298–299 questionnaires, 304–305 scales, 306–309

research knowledge and, 140–141 role effectiveness model, 469–471, 470f

propositions of, 469–471 services, 469

Nursing Care Report Card, 474 Nursing journals. see Journals Nursing process

as basis for understanding the quantitative research process, 38–40

comparing problem solving with, 38–39 comparison to problem solving and

research process, 39t

Nursing Reference Center (NRC), evidence-based practice resource, 420t

Nursing research, 1–30 from 1980 through 1990s, 12–13 acquiring knowledge through, 19–21 characteristics and roles of, 3 designs for comparative descriptive designs, 216 correlational designs, 217–221 descriptive designs, 212–216

development of, 9–15, 9t ethics in, 93–128 examining interventions in, 230 goals for twenty-first century, 14 history of, 9t, 11–12 informed consent and, 111–116 role of nurses in, 25–26, 26f from 1900s through 1970s, 11–12 statistics in descriptive statistics, 330–336 determining appropriateness of

inferential statistics, 337–339 elements of statistical analysis

process, 319–324 to examine differences, 347–353 to examine relationships, 340–344 interpreting research outcomes,

353–357, 356b, 357b to predict outcomes, 344–346 theories and concept of statistical

analysis process, 324–330 Nursing Research, 50t

history of, 9t, 11 Nursing Role Effectiveness Model, 469–471

propositions of, 469–471 Nursing Science Quarterly, 9t, 12 Nursing-sensitive patient outcome

(NSPO), 471 definitions, 472t

O

Objectives, purpose of, in research studies, 145

Observational measurements, 300–301 critical appraisal guidelines for, 300b research example of, 301b, 301t

Observations in qualitative research, 86, 87b structured versus unstructured, 300

Odds ratio (OR), 435 Office of Research Integrity (ORI), 122 Oncology Nursing Society (ONS), 476

website, 456, 476 One-tailed test of significance, 327–328,

328f Online encyclopedia, 166 ONS (Oncology Nursing Society), 476 Open-ended interviews. see Unstructured

interviews Operational definitions, 192, 193t

bias protection and, 212–213

Operational definitions (Continued) middle range theories with, 203t of variables, 44, 44b

in quantitative research, 155, 158 in quasi-experimental study, 56b

OR. see Odds ratio (OR) Ordinal-level measurement, 284–285 Orem’s self-care deficit theory, 201t ORI. see Office of Research Integrity

(ORI) Outcome reporting bias, 433 Outcomes benefit-risk ratio and, 119–120 discussion of, 48 predictions and, 7–8 using statistics to predict, 344–346

Outcomes assessment instruments, characteristics of, 489t

Outcomes research, 21, 466–499 advanced practice nursing, 476 critical appraisal of, 492–493 essential areas of, 21 with evidence-based practice, 21 federal government involvement in,

473–476 focus of, 467 methodologies for, 481–491

measurement methods, 488–491 samples and sampling, 481–483 study designs, 483–488

nurse’s role in, 469–471 nursing practice and, 477–481

nursing-sensitive outcomes, 469–471 patient and health

of dependent role, 469–471 of independent role, 469–471 of interdependent role, 469–471

problems and purposes in, 140, 141t representativeness of sample in,

252–257 statistical methods for, 491–492

analysis of change, 491 analysis of improvement, 491–492

structure in, 469–471 theoretical basis of, 468–469

Outliers, 323

P

Pain definition of, 472t grounded theory research on, 71, 71t

Paired groups, 338 Parallel synthesis, 441 Parametric analyses, 338 Paraphrasing, definition of, 184 Partially controlled settings, 38,

277, 277b Participants definition of population, 250 selection of, in qualitative research, 82

Patient responses, areas of outcomes research, 21

523Index

Patient satisfaction areas of outcomes research, 21 definition of, 472t

Pearson, Karl, on statistical approaches between variables, 33

Pearson product-moment correlation, 340–342

research example of, 342b results, interpreting of, 341–342

Pediatric TB, prevention in Virginia, 79b, 81f

Peer-reviewed, definition of, 167 Percentage distribution, 330t, 331, 332f Periodicals, description of, 166 Permanent damage

certainty of, 109 risk of, 109

Personal experience, acquiring knowledge through, 17

Phase I: Preparation, in Stetler Model of Research Utilization to Facilitate Evidence-Based Practice, 447f, 448

Phase II: Validation, in Stetler Model of Research Utilization to Facilitate Evidence-Based Practice, 447f, 448

Phase III: Comparative Evaluation/ Decision Making, in Stetler Model of Research Utilization to Facilitate Evidence-Based Practice, 447f, 448–449

Phase IV: Translation/application, in Stetler Model of Research Utilization to Facilitate Evidence- Based Practice, 447f, 449

Phase V: Evaluation, in Stetler Model of Research Utilization to Facilitate Evidence-Based Practice, 447f, 449

Phenomena definition of, 67–68

in theory, 190 descriptive designs and, 214

Phenomenological research, 136–139 definition of, 69–70 examples of, 70b, 137t introduction of, 21 literature review purpose in, 182t philosophical orientation of, 69–70

Phenomenologists, 69, 164–165 Phenomenology, 69 outcome of, 70

PHI. see Protected Health Information (PHI)

Philosophies, definition of, 191 PHS. see Public Health Service (PHS) Physiological measures, 292

accuracy of, 292 error in, 293–294 precision of, 292 research example of, 293b, 299b

Physiological study, framework for, 205–206

research example, 205b, 206f

PICO format, 423, 424, 432, 443, 462 Pilot study, 45 Plagiarism, in research, 122 Plans, in problem-solving, nursing

process and research process, 39t Policy on Humane Care and Use of

Laboratory Animals, by Public Health Service, 124

Population-based studies, 487 Populations

definition of, 46, 250 samples and, 248–280, 250f nonprobability quantitative

sampling methods, 263–265 probability sampling methods,

257–263 representativeness, 252–257 research settings, 276–278 sample size in qualitative studies,

274–275 sample size in quantitative studies,

266–269 sampling in qualitative research,

270–273 sampling theory, 249–250

Positive likelihood ratio, 298 Positive relationships, in Pearson

correlation analysis, 341 Post-doctorate degree, roles of, in nursing

research, 27 Post-test-only design, 233–234, 234f

with control group design, 239–240, 239b

Posthoc analyses, 347 Power, 266

definition of, in statistics, 329 Power analysis

of sample size, 266 in statistics, 329

Practical research. see Applied research Practice pattern, 481 Practice style, 481 Practice theories, middle range theories

and, 195–197 Practicing nurses, critical appraisal of

studies by, 363–364 Precision

definition of, in quantitative research, 36

of physiological measures, 289t, 292 Predictions, nursing research definition

of, 7–8 Predictive correlational design, 220, 220b,

220f Preferred Reporting Items for Systematic

Reviews and Meta-Analyses (PRISMA) statement, 421–423, 425

flow diagram, 426f Pregnancy, definition of, 104 Pregnant women

ethical laws concerning, 104 legal issues concerning, 104

Premise, definition of, 18 Pretest and post-test designs with comparison group, 233–236, 233f,

236b in experimental design, 237–239, 239f

Pretest-post-test control group design, 239f Preventorium, 79b Primary data, 311 Primary sources definition of, 167 of historical data, 79, 79b

Principle of beneficence, 98, 108 Principle of justice, 98 Principle of respect for persons, 98 PRISMA. see Preferred Reporting Items

for Systematic Reviews and Meta- Analyses (PRISMA) statement

Privacy definition of, 105 invasion of, 105

Privacy Rule, of Health Insurance Portability and Accountability Act, 99

authorization for research uses and disclosure, 115

clarification of, 100t de-identifying protected health

information, 106 influence on institutional review

boards, 118–119 Probability normal curve and, 326–327 of relative versus absolute

causality, 223 Probability sampling, methods of,

257–263 cluster sampling, 258t, 261, 262b versus nonprobability sampling

methods, 258t simple random sampling, 258t, 259,

259b stratified random sampling, 258t, 260,

260b systematic sampling, 258t, 262–263,

263b Probability theory, in statistics,

324–325 Probes, in qualitative research, 83 Problem definition, in problem-solving,

nursing process and research process, 39t

Problems. see Research problems Problems in Measuring Change, 491 Problem-solving processes, 38 comparison to nursing and research

process, 39t Processes evaluating in Donabedian’s Theory, 469 variables and outcomes, studies

investigating the relationship between, 482t

Professional nurse, negotiating the role of, 72b, 73f

524 Index

Professional standards review organizations (PSROs), 13

Proficient stage, of nursing experience, 17 Propositions

definition of, 18 research examples of, 194t within theories, 193–194

Prospective cohort study, 484 Protected Health Information (PHI), 106 Protection of Human Subjects, federal

regulations for, 99–100, 100t Proximal outcome, 478 PSROs. see Professional standards review

organizations (PSROs) PsychARTICLES, as database for nursing

literature reviews, 177t PsychINFO, evidence-based practice

resource, 420t Psychological and Behavioral Sciences

Collection, as database for nursing literature reviews, 177t

Psychological distress, definition of, 472t Public Health Service (PHS), Policy on

Humane Care and Use of Laboratory Animals, 124

Publications bias, 433 content of, 166–167 types of, 166

Published study, appraising of, in literature review, 168

PubMed, National Library of Medicine. see MEDLINE

Pure research. see Basic research Purposeful sampling, 258t, 270, 271b Purposive sampling, 258t, 270, 271b

Q

QSEN. see Quality and Safe Education for Nurses (QSEN) initiative

Qualitative approach, in qualitative studies, 393

Qualitative Health Research, 9t, 13 Qualitative metasummaries, 437–438 Qualitative research

characteristics of, 19t critical appraisal of

for nursing practice, 361–413 process of, 389–394

definition of process, 20 history of, 13 identifying components of, in

qualitative studies, 389–391 introduction to, 19–21 probability and nonprobability

sampling methods, 258t problems and purposes in types of,

136–140, 137t purpose of literature review in, 164–165 research concepts in, 156 research objectives in, 146 research questions in, 148b

Qualitative research (Continued) types and classification of, 20b, 21

Qualitative research process approaches to, 68–80, 69b ethnographic research, 74–75, 75b exploratory-descriptive, 76–77, 77b grounded theory research, 70–73,

72b, 73f historical research, 78–80, 79b, 81f phenomenological research, 69–70,

70b data analysis of, 88–89, 89b, 90b data collection methods of, 82–87 data management, 88 definition of, 67 introduction to, 66–92 methodologies of, 81–82 participant selection, 82 researcher-participant relationships,

82 rigor in, 68 values of qualitative researchers, 67–68

Qualitative research synthesis, 23 Qualitative researchers, values of, 67–68 Qualitative studies

critical appraisal of, 375–388, 389, 394–409

key principles for, 365b literature review in, 172–175, 173b research example of, 395b

data analysis in, 391, 393 data collection in, 391, 393 identifying components of, 390–391 intellectual criticalappraisalof,365–366 literature summary for, 182t research process in, guidelines for

identifying components of, 389 sample size in, 274–275, 276b adequacy of, 275b critical appraisal guidelines for, 275b nature of the topic, 274–275 quality of information, 275 scope of the study, 274 study design, 275

strengths and weaknesses in, 391–394 trustworthiness and meaning of, 394

Quality and Safe Education for Nurses (QSEN) initiative, 15

Quality of care assessment of, 468, 469f levels and scopes of concern, 468f standards, 480

Quantitative research, 31–65 characteristics of, 19t clarifying designs for, 210–247

correlational designs, 215b, 217–221 descriptive designs, 212–216, 215b examining causality, 229–232 experimental designs, 234b, 237–240,

238f important design concepts, 222–224 mixed-methods approaches,

243–244

Quantitative research (Continued) nursing studies, 212, 213f quasi-experimental designs, 232–236, 234b, 235f

randomized controlled trials, 241–242 validity of studies, 224–229

control in, 36–37 critical appraisal of

for nursing practice, 361–413 process of, 366–375

defining terms relevant to, 35–38 definition of, 32–38 identifying problems and purpose in,

133–136 initial critical appraisal guidelines, 56b introduction to, 19–21 measurement and data collection in,

281–316 measurement theory concepts, 283–292

nonprobability sampling methods in, 263–265

probability versus nonprobability sampling methods in, 258t

problems and purposes in types of, 133t process

definition of, 19–20 identifying the steps of, 40–48, 40f problem-solving and nursing processes and, 38–40

purpose of literature review in, 163–164 representativeness of sample in,

252–257 research objectives in, 146 research problems and purpose of, 131b research questions in, 147b rigor in, 36 types and classification of, 20–21, 33–34 variables in, types of, 153–155

Quantitative studies critical appraisal of, 375–388

key principles for, 365b literature review in, 168–171, 169b research example of, 376b, 381f, 385f, 386f

data analysis in, 374 data collection in, 374 determining strengths and weaknesses

in, 370–374 evaluating credibility and meaning of,

374–375 identifying steps of research process in,

366–370 intellectual critical appraisals of,

365–366 literature summary for, 182t sample size in, 269b

adequacy of, 266, 268b critical appraisal guidelines for, 268b

data analysis techniques, 268–269 effect size of, 267 measurement sensitivity, 268

525Index

Quantitative studies (Continued) number of variables, 267 types of, 267

Quasi-experimental designs algorithm for determining types of,

235f definition of, 232–233, 234b examining causality in, 229–230

Quasi-experimental research control in, 37t example of, 133t introduction of, 20b, 21 practice reading, 55–62 problems and purposes of, 136 purpose of, 34, 56–59 steps of research process, 56b, 57f

Questionnaires, 304–305 critical appraisal guidelines for, 305b research example of, 305b

Questions, 153 in qualitative research, 83

Quota sampling, as nonprobability sampling method, 258t, 265, 265b

R

Race, as demographic variable, 157–158 Random measurement error, 287 Random numbers table, 259t Random sampling, 37, 254–255 Random variation, definition of, 252 Randomized controlled trials (RCTs),

241–242, 242b, 418 Range, 333–334 Rapid Antigen Diagnostic Testing

(RADT) sensitivity of, 297t specificity of, 297t

Rating scales, 307, 307f Ratio-level measurement, 286 RD. see Risk difference (RD) Readability level, 289t, 291 Reading research reports, 49–55

versus comprehending, 55 versus skimming, 54–55 tips for, 54–55

Reasoning deductive, 18 definition of, 18 inductive, 18

Reasoning process, in qualitative research, 68

Recall, of information, in retrospective cohort study, 486

Recommendations for further studies, 356–357

Recruitment, of study participants, 310 Reference, 165–166

list of, 186 checking of, 185 creating of, 184–185

Reference management software, 178, 181, 186

References section, of research reports, 51, 54

Referred journals, 364 Refusal rates

adequacy of, 255b research example of, 255b of subjects, 253

RefWorks, 178 Regression analysis, 344–346 outcome of, 345 research example of, 345b

Regression coefficient, 345 Relational statements, within

theories, 193 Relationships, using statistics to examine,

340–344 Relative risk (RR), 435 Relevant studies, definition of, 167 Reliability, 287–290

interrater, 289t, 290 measurement methods, 289t, 293b of measurement methods, in statistical

analysis process, 323 research example of, 293b test-retest, 289–290, 289t

Reliability testing, 288–290 Relief, in comfort, 196–197 Replication studies, definition of, 167 Representativeness

definition of, 252 of sample in quantitative and outcomes

research, 252–257 Research. see also Basic research

definition of, 3 disclosure authorization, 115 ethics, use of animals, 123–125 informed consent and, 111 integrative review of, 23–24 literature review in, 162–188 populations and samples, 248–280 probability sampling methods,

257–263 quantitative, nonprobability

sampling methods in, 263–265 representativeness, 252–257 research settings, 276–278 sample size in qualitative studies,

274–275 sample size in quantitative studies,

266–269 sampling in qualitative research,

270–273 sampling theory, 249–250

settings, 38 statistics in, 317–360 decision tree/algorithm, for

identifying an appropriate analysis technique, 339f

descriptive statistics, 330–336 determining appropriateness of

inferential statistics, 337–339 elements of statistical analysis process, 319–324

Research (Continued) to examine differences, 347–353 to examine relationships, 340–344 interpreting research outcomes, 353–357, 356b, 357b

to predict outcomes, 344–346 theories and concept of statistical analysis process, 324–330

synthesis of findings, 22 systematic review of, 22

Research aims, 145–146, 146b Research-based evidence, developing

clinical questions to identify, for use in practice, 443–447, 444t, 445t

Research concepts, 153–158 in qualitative research, 156

Research designs, 63 algorithm for determining type of, 213f comparative descriptive, 216 concepts important to, 222–224

bias, 223 causality, 222 control, 224 manipulation, 224 multicausality, 223 probability, 223

correlational, 215b, 217–221 definition of, 211 descriptive, 212–216 descriptive correlational, 218–219, 218f Fisher, Ronald, on, 33 model testing, 221, 221b, 222f predictive correlational, 220, 220b, 220f for quantitative studies, 211, 368

important design concepts, 222–224 nursing studies, 212

randomized controlled trials, 241–242 Research evidence, levels of, 24–25, 24f Research frameworks, 198 Research hypotheses definition of, 151 versus statistical, 151

Research in Nursing & Health, 9t, 12 Research misconduct definition of, 122 understanding, 122–123

Research objectives, 145–146 critical appraisal guidelines for, 146b definition of, 43–44 examples of, 146b strengths and weaknesses of, in

quantitative studies, 372 Research outcomes. see also Outcomes

research interpretation of, 48

Research problems, 129–161 critical appraisal guidelines, 131b definition of, in quantitative research,

41, 41b determining significance of, 140–143 feasibility of, 143–145, 144b key concepts, 158 in outcomes research, 141t

526 Index

Research problems (Continued) and purposes, 131–132 in qualitative research, 137t in quantitative research, 133t quantitative study examples of, 131b research example of, 146b

Research process comparing the nursing process with,

39–40 comparison to problem-solving and

nursing process, 39t steps of, in quantitative studies, 366–370

Research proposals, critical appraisal of, 364–365

Research purposes, 129–161 critical appraisal guidelines for, 131b definition of, in quantitative research,

41, 41b determining significance of, 140–143 feasibility of, 143–145, 144b key concepts, 158 in outcomes research, 141t in qualitative research, 137t in quantitative research, 133t quantitative study examples of, 131b

Research questions, 147–148 critical appraisal guidelines for, 146b definition of, in quantitative research,

43–44 from a qualitative study, 148b from a quantitative study, 147b

Research reports, 145–153 abstract, 51 analyzing, 55 comprehending, 55 content of, 51–54, 63 discussion, 51 introduction, 51 major sections of, 51b methods, 51 reading, 49–55

tips for, 54–55 references, 51 results, 51 sections of, 164 versus skimming, 54–55 sources of, 50

Research settings. see Settings Research syntheses, critically appraising,

421–443 Research topic, 130

in outcomes research, 141t in qualitative research, 137t in quantitative research, 133t

Research variables, 154, 158 Researcher-participant relationships, in

qualitative research, 82 Researchers

critical appraisal of studies by, 363–364

expertise of, 144 Resources, historical research, 79b Respect for persons, principle of, 98

Results analysis of variance (ANOVA), 351–352 chi-square test of independence,

347–348, 348b of descriptive statistics, 336, 336b mixed, 354 nonsignificant, 353–354 significant and predicted, 353 significant and unpredicted, 354 t-test, 349–350, 349b types of, 353–354 unexpected, 354

Results section, of research reports, 51b, 53–54

Retrospective cohort study, 485 Review of literature. see Literature reviews Review of relevant literature, in

quantitative research, 41–42 Revision, in problem-solving, nursing

process and research process, 39t Right to privacy, 105–106 Rights

to anonymity and confidentiality, 106–107

to fair selection and treatment, 107–108 to protection from discomfort and

harm, 108–109 to self-determination, 101

Rigor definition of, in quantitative research, 36 in qualitative research, 68

Risk difference (RD), 436 Risks

balancing with benefits, Nuremberg code and, 95–96

benefit ratio and, 119–121, 119f minimal, 118 permanent damage of, to subjects, 109 temporary discomfort, 108–109

Role modeling, learning through, 17–18 Rosenthal effect. see Experimenter

expectancies Roy Adaptation Association, 195 Roy Adaptation Model (RAM), 195 RR. see Relative risk (RR)

S

Sample attrition, 253–254 adequacy of, 255b research example of, 255b

Sample characteristics, in demographic variables, 157–158

Sample retention, 253–254 adequacy of, 255b research example of, 255b

Sample sizes in qualitative studies, 274–275 in quantitative studies, 266–269 adequacy of, 266, 268b critical appraisal guidelines for, 268b data analysis techniques, 268–269 effect size, 267

Sample sizes (Continued) measurement sensitivity, 268 number of variables, 267 types of, 267

Sample sources, large databases as, 483, 483f

Samples definition of, 46, 249–250 description of, in statistical analysis

process, 320–322, 320b, 321b in outcomes research, 481–483 populations and, 248–280, 250f

nonprobability sampling methods, in quantitative research, 263–265

probability sampling methods, 257–263

representativeness, 252–257 research settings, 276–278 sample size in qualitative studies, 274–275

sample size in quantitative studies, 266–269

sampling in qualitative research, 270–273

sampling theory, 249–250 Sampling definition of, 37

in sampling theory, 249–250 in outcomes research, 481–483 in qualitative research, 270–273

network sampling, 271–272, 272b purposeful or purposive sampling, 270, 271b

theoretical sampling, 273 Sampling criteria, in sampling theory, 251,

256f adequacy of, 255b research example of, 255b

Sampling frames, 254–255 Sampling methods, probability and

nonprobability, 256f, 258t Sampling plans, 255–257, 256f

definition of, in sampling theory, 249–250

Sampling theories eligibility criteria, 251 populations and elements, 250–251,

250f Sanitation, Florence Nightingale’s work

on, 11 Saturation, of study data, 274 Scales, 306–309 critical appraisal guidelines for, 309b Likert, 307–308 rating, 307, 307f research example of, 309b visual analog, 308–309, 308f

Scatterplots, 335–336, 335f, 336f, 345f Scheffé’s test, 351 Scholarly Inquiry for Nursing

Practice, 9t Scientific rigor. see Rigor Scientific theory, 198–199

527Index

Screening tests accuracy of, 295 likelihood ratios, 298 outcomes of, 295 quality determination of, 295–298 sensitivity of, 295–297, 296b, 296t specificity of, 295–297, 296b, 296t

SD. see Standard deviation (SD) Search

refining of, 178–179, 178t, 179t use of table or other method to

document the results of, 178 Secondary analysis, 488–489 Secondary data, 311 Secondary sources

definition of, 167 of historical data, 79, 79b

Selection and treatment, interaction of, 229

Selective sampling, 270 Self-care, definition of, 472t Self-care adherence behaviors, 44b Self-care deficit theory, 195t

constructs, concepts, variables, and data related to Orem’s, 201t

research example of, 200b, 200f Self-determination

rights to, 101 violation of, 101

Seminal studies, definition of, 167 Semistructured interviews, in qualitative

research, 83 Sensitivity, research example of, 296b Serendipitous results, 354 Settings

highly controlled, 38, 278, 278b natural, 38, 277, 277b partially controlled, 38, 277, 277b research, 276–278

definition of, 38 and treatment, interaction of, 229

Sigma Theta Tau journal, description of, 9t, 12

Significance, exploring findings, 354–355 Significant and predicted results,

353–354 Significant and unpredicted results, 354 Simple hypotheses

versus complex, 150 definition of, 150

Simple linear regression, 344 Simple random sampling, as probability

sampling method, 258t, 259, 259b Situation-specific theories, 197 SMD. see Standardized mean difference

(SMD) Smoking, lung damage and, as

correlational research example, 34 SMR. see Standardized mortality ratio

(SMR) Snowball sampling, 258t SORT. see Standardized Reporting of

Trials (SORT)

Sources citing of, 180 comprehending, 180 primary and secondary historical, 79,

79b Specific propositions, within theories,

193–194, 194t Specificity, research example of, 296b Stability, 289–290 Standard deviation (SD)

definition of, 334 normal curve and, 327f

Standardized mean difference (SMD), 433–434, 434f, 435

Standardized mortality ratio (SMR), 485–486

Standardized Reporting of Trials (SORT), 241

Standardized scores, 335 Standards for Management Information

Systems (MIS), 473 Standards of care

definition of, 481 evaluating in Donabedian’s theory, 480

Starvation, Florence Nightingale’s work on, 11

Statements relational, 193–194 in theory, 190

Statistical analysis Fisher, Ronald, on, 33 outcomes of, 353–357 conclusion, 355 critical appraisal guidelines

for, 356b findings, 354 generalization of findings, 356 implications, 356 limitations, 355 recommendations for further

studies, 356–357 process of elements of, 319–324 theories and concept of, 324–330

in quantitative studies, 370 Statistical conclusion validity, 224–226,

225t Statistical hypotheses

definition of, 151 versus research, 151

Statistical methods, for outcomes studies analysis of change, 491 analysis of improvement, 491–492

Statistical outcomes, interpreting, 353–357

conclusion of, 355 critical appraisal guidelines for, 356b findings, 354 generalization of findings, 356 implications, 356 limitations of, 355 recommendations for further studies,

356–357

Statistical techniques, definition of, 319 Statistics, in research, 317–360 descriptive, 330–336 determining appropriateness of

inferential statistics, 337–339 elements of statistical analysis process,

319–324 to examine differences, 347–353 to examine relationships, 340–344 interpreting research outcomes,

353–357, 356b, 357b to predict outcomes, 344–346 theories and concept of statistical

analysis process, 324–330 Steps of Research Utilization to Facilitate

Evidence-Based Practice, 9t Stetler Model of Research Utilization to

Facilitate Evidence-Based Practice, 447–449, 447f, 462

Phase I: Preparation, 447f, 448 Phase II: Validation, 447f, 448 Phase III: Comparative Evaluation/

Decision Making, 447f, 448–449 Phase IV: Translation/Application, 447f,

449 Phase V: Evaluation, 447f, 449

Stratification, 260 Stratified random sampling, as probability

sampling method, 258t, 260, 260b Structural variables, 478 and outcomes, studies investigating the

relationship between, 479t Structure, in outcomes, 469–471 Structured interview, 302–303 Structured observational measurement, 300 Structures of care, definition of, 478 Study designs in outcomes research, 483–488

economic studies, 488 ethical studies, 488 population-based studies, 487 prospective cohort studies, 484–485 retrospective cohort studies, 485–487

in qualitative study, 275 Study interventions, definition of, 38, 44b Study validity, 224 Subject attrition, 227 Subjects. see also Participants availability of, 144–145 definition of population, 250 fair selection and treatment of, 107–108 informed consent, 111 legally or mentally competent, 101–102 with mental illness or cognitive

impairment, 104 protection of

with DHEW regulations, 98 human rights and, 100–101 Nuremberg code and, 95–96

recruitment of, 310 selection and assignment of, to groups,

227

528 Index

Subjects (Continued) self-determination rights of, 101 terminally ill, ethical considerations, 104

Substantive theories, 195–196 Summary, of literature review, 183 Summated scales, 306–307 Sunshine Model of Transcultural Nursing

Care, 74 Support, emotional, 191 Symbolic interaction theory, 70–71 Symmetrical, definition of, 340–341 Symptoms, definition of, 472t Synthesis of sources, 183 Syphilis, studied in African Americans, in

unethical Tuskegee study, 97 Systematic bias. see Systematic variation Systematic measurement error, 287 Systematic review

critically appraising, 421–430, 421t definition of, 421, 462 possible biases for, 433–434 of research, 22 study selection, 427f

Systematic sampling, as probability sampling method, 258t, 262–263, 263b

Systematic variation, definition of, 252–253

Systems model, 195t

T

t-test, 349–350 interpreting results of, 349–350 research example of, 349b

Tailedness, of normal curves, 327–328 Target population, 256f

definition of, 250 representativeness, 252–257

Telephone interviews, in qualitative research, 83

Temporary discomfort, 108–109 unusual levels of, 109

Tentative theory, 198 framework from, 204

research example of, 204b Terminally ill subjects, ethical

considerations, 104 Test-retest reliability, 289–290, 289t Testable hypothesis, 152–153 Text, as qualitative data source, 87 Textbooks, 166 Themes, of qualitative research, 89 Theoretical literature, 166–167

discussion of, 183 Theoretical perspective, in quantitative

studies, 367 Theoretical sampling, 258t, 273, 273b Theoretical thinking, levels of, 194–199 Theories

definition of, 190–191 Donabedian’s, 468 elements of, 191–194, 192f

Theories (Continued) concepts, 191–192 relational statements, 193–194, 193f,

194t frameworks, 189–209 generate and refine, in basic research, 35 grand nursing, 194–195, 195t middle range, 195–197, 196t framework based on, 202–203, 202b,

203f, 203t practice, 195–197 scientific, 198–199 self-care deficit, 195t, 200b, 200f, 201t in study framework, 42 substantive, 195–196 tentative, 198 framework from, 204, 204b

Theory of caring, 195t Therapeutic research, 96

benefit-risk ratio in, 120 guide to informed consent, for children,

103t versus nontherapeutic research, 103t

Thesis, definition of, 166 Time lag bias of studies, 433 Total variances, 351 Traditions, definition of nursing, 16 Transcendence, in comfort, 196–197 Transcription, in qualitative research, 88 Transcripts, of interviews, 69–70, 88 Translation research

definition of, 461, 462 introduction to, 461

Treatment group. see Experimental group Trial and error approach, to acquiring

knowledge, 17 Triangulation, 244 True measure, 286 True negative, 295, 296t True positive, 295, 296t True score, 286 Trustworthiness, 391–392 Tukey’s honestly significantly difference

(HSD) test, 351 Tuskegee Syphilis Study, 97 Two-tailed test of significance, 327–328,

328f Type I error, in decision theory, 328–329,

329t Type II error, in decision theory, 328–329,

329t controlling risk of, 329

Typical descriptive design, 214–215, 215b, 215f

U

UAP. see Unlicensed assistive personnel (UAP)

Unconscious patients, legal issues concerning, 101–102

Unethical research, historical events surrounding, 96–97

Unexpected results, 354 Unexplained variances, 341 Ungrouped frequency distribution, 330,

330t Uniform Hospital Discharge Data Set, 472 Universal Minimum Health Data Set, 472 Unlicensed assistive personnel (UAP),

475t Unstructured interviews, 302–303 in qualitative research, 83

Unstructured observations, 300 U.S. Preventive Services Task Force,

website, 456 Users’ Guides to the Medical Literature, 492

V

Validity construct, 291 content, 289t, 291 from contrasting groups, evidence of,

289t, 291 from convergence, evidence of, 289t,

291 design, 211 from divergence, evidence of, 289t,

291–292 of instrument, 290–292, 293b measurement methods, 289t and quasi-experimental designs,

232–233 research example of, 293b types of, 225t uncontrolled threats to, in experimental

design, 224, 239f Variability. see Measures of dispersion Variables causality and, 222 confounding, 154 correlational design, 217–218 critical appraisal guidelines for, 155b definition of, 153

in quantitative research, 40f, 44 in theory, 191, 192f

demographic, 157–158 within descriptive designs, 212–213 environmental, 154–155 experimental, 153 extraneous, 37, 154–155 independent and dependent, 153 number of, in quantitative studies, 267 and outcomes, studies investigating the

relationship between process, 482t structural, 479t

in quantitative research definitions of, 155, 155b types of, 153–155

in quasi-experimental research, 232–233, 233f, 234f

related to Orem’s self-care deficit theory, 201t

research, 154, 158

529Index

Variables (Continued) strengths and weaknesses of, in

quantitative studies, 372 ungrouped frequency distribution, 330,

330t Variances, 334

between-group, 351 calculation of, 330t, 334 explained, 341 extraneous, in study setting, 226 total, 351 unexplained, 341 within-group, 351

VAS. see Visual Analog Scales (VAS) Ventilation, Florence Nightingale’s work

on, 11 Verification, of study data, 274 Vigilance, in exploratory-descriptive

qualitative research, 77b Visual Analog Scales (VAS), 308–309, 308f Voluntary consent, 113

W

Water, purity of, Florence Nightingale’s work on, 11

Websites, 166 of Academic Center for Evidence-Based

Nursing, 455 of Agency for Healthcare Research and

Quality (AHRQ), 473

Websites (Continued) of American Nurses Credentialing

Center (ANCC), 478 of Association of Women’s Health,

Obstetric, and Neonatal Nurse, 455

on Belmont Report, 98 of Center for Health Evidence, 455 for Cochrane Collaboration, 419 concerning declaration of Helsinki,

96–97 on ethical principles, 98 evidence-based guidelines, 25 for Guidelines Advisory Committee,

455 for Guidelines International Network,

455 of Healthy People 2020, 143 of HerbMed, Evidence-Based Herbal

Database, 456 for HIPAA Privacy Rule, 99–100 for identifying research priorities, 142 on institutional review, 117 of MD Consult, 456 of National Association of Neonatal

Nurses, 456 of National Institute for Clinical

Excellence (NICE), 456 for National Institute of Nursing

Research, 14–15

Websites (Continued) on Office of Research Integrity, 122 of Oncology Nursing Society, 456 for reference management software, 178 of U.S. Preventive Services Task Force,

456 Weight, as physiological measure, 292 Western Journal of Nursing Research, 9t, 12,

418 Wikipedia, 166 Willowbrook Study, 97 Within-group variances, 351 Wong-Baker FACES Pain Rating Scale,

307f World Health Organization (WHO),

nursing research priorities, 143 Worldviews on Evidence-Based Nursing, 9t,

14 Writing, literature review, 183–185 Written search records, 178t

X

X-axis, in scatterplot, 335–336, 335f

Y

Y-axis, in scatterplot, 335–336, 335f

Z

Z-score, 335

530 Index

LEVELS OF RESEARCH EVIDENCE

  • Front Cover
  • Inside Front Cover
  • Contents
  • Understanding Nursing Research: Building an Evidence-Based Practice
  • Copyright
  • Contributor and Reviewers
  • Dedication
  • Preface
    • Learning Resources to Accompany Understanding Nursing Research, 6th edition
      • Evolve Instructor Resources
        • Test Bank
        • PowerPoint Slides
        • Image Collection
        • NEW TEACH for Nurses Lesson Plans
      • Evolve Student Resources
      • Study Guide
  • Acknowledgments
  • Chapter 1: Introduction to Nursing Research and Evidence-Based Practice
    • WHAT IS NURSING RESEARCH?
    • WHAT IS EVIDENCE-BASED PRACTICE?
    • PURPOSES OF RESEARCH FOR IMPLEMENTING AN EVIDENCE-BASED NURSING PRACTICE
      • Description
      • Explanation
      • Prediction
      • Control
    • HISTORICAL DEVELOPMENT OF RESEARCH IN NURSING
      • Florence Nightingale
      • Nursing Research: 1900s through the 1970s
      • Nursing Research: 1980s and 1990s
      • Nursing Research: in the Twenty-First Century
        • Current Actions of the National Institute of Nursing Research
        • Linking Quality and Safety Education for Nursing Competencies and Nursing Research
    • ACQUIRING KNOWLEDGE IN NURSING
      • Traditions
      • Authority
      • Borrowing
      • Trial and Error
      • Personal Experience
      • Role Modeling
      • Intuition
      • Reasoning
        • PARTICULAR INSTANCES
        • GENERAL STATEMENT
        • PREMISES
        • CONCLUSION
    • ACQUIRING KNOWLEDGE THROUGH NURSING RESEARCH
      • Introduction to Quantitative and Qualitative Research
        • Types of Quantitative and Qualitative Research
      • Introduction to Outcomes Research
    • UNDERSTANDING BEST RESEARCH EVIDENCE FOR PRACTICE
      • Strategies Used to Synthesize Research Evidence
      • Levels of Research Evidence
      • Introduction to Evidence-Based Guidelines
    • WHAT IS YOUR ROLE IN NURSING RESEARCH?
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 2: Introduction to Quantitative Research
    • WHAT IS QUANTITATIVE RESEARCH?
      • Types of Quantitative Research
        • Descriptive Research
        • Correlational Research
        • Quasi-Experimental Research
        • Experimental Research
      • Defining Terms Relevant to Quantitative Research
        • Basic Research
        • Applied Research
        • Rigor in Quantitative Research
        • Control in Quantitative Research
        • Extraneous Variables
        • Sampling
        • Research Settings
        • Study Interventions
    • PROBLEM-SOLVING AND NURSING PROCESSES: BASIS FOR UNDERSTANDING THE QUANTITATIVE RESEARCH PROCESS
      • Comparing Problem Solving with the Nursing Process
      • Comparing the Nursing Process with the Research Process
    • IDENTIFYING THE STEPS OF THE QUANTITATIVE RESEARCH PROCESS
      • Research Problem and Purpose
      • Review of Relevant Literature
      • Study Framework
      • Research Objectives, Questions, or Hypotheses
      • Study Variables
      • Study Design
      • Population and Sample
      • Measurement Methods
      • Data Collection
      • Data Analysis
      • Discussion of Research Outcomes
    • READING RESEARCH REPORTS
      • Sources of Research Reports
      • Content of Research Reports
        • Abstract Section
        • Introduction Section
        • Methods Section
        • Results Section
        • Discussion Section
        • References Section
      • Tips for Reading Research Reports
    • PRACTICE READING QUASI-EXPERIMENTAL AND EXPERIMENTAL STUDIES
      • Quasi-Experimental Study
      • Experimental Study
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 3: Introduction to Qualitative Research
    • VALUES OF QUALITATIVE RESEARCHERS
    • RIGOR IN QUALITATIVE RESEARCH
    • QUALITATIVE RESEARCH APPROACHES
      • Phenomenological Research
        • Philosophical Orientation
        • Phenomenology's Outcome
      • Grounded Theory Research
        • Intended Outcome
      • Ethnographic Research
        • Intended Outcome
      • Exploratory-Descriptive Qualitative Research
        • Philosophical Orientation
        • Intended Outcome
      • Historical Research
        • Philosophical Orientation
        • Intended Outcome
    • QUALITATIVE RESEARCH METHODOLOGIES
      • Selection of Participants
      • Researcher-Participant Relationships
    • DATA COLLECTION METHODS
      • Interviews
      • Focus Groups
      • Observation
      • Text as a Source of Qualitative Data
    • DATA MANAGEMENT
      • Organizing Data Files
      • Transcribing Interviews
    • DATA ANALYSIS
      • Codes and Coding
      • Themes and Interpretation
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 4: Examining Ethics in Nursing Research
    • HISTORICAL EVENTS INFLUENCING THE DEVELOPMENT OF ETHICAL CODES AND REGULATIONS
      • Nazi Medical Experiments
      • Nuremberg Code
      • Declaration of Helsinki
      • Tuskegee Syphilis Study
      • Willowbrook Study
      • Jewish Chronic Disease Hospital Study
      • Department of Health, Education, and Welfare, 1973: Regulations for the Protection of Human Research Subjects
      • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
      • Current Federal Regulations for the Protection of Human Subjects
    • PROTECTING HUMAN RIGHTS
      • Right to Self-Determination
        • Violation of the Right to Self-Determination
      • Persons with Diminished Autonomy
        • Study participants with legal and mental diminished autonomy
          • Neonates
          • Children
          • Pregnant women and fetuses
          • Persons with mental illness or cognitive impairment
          • Terminally ill subjects
          • Persons confined to institutions
      • Right to Privacy
        • De-Identifying Protected Health Information under the Privacy Rule
        • Limited Data Set and Data Use Agreement
      • Right to Anonymity and Confidentiality
      • Right to Fair Selection and Treatment
        • Fair Selection and Treatment of Subjects
      • Right to Protection from Discomfort and Harm
        • No Anticipated Effects
        • Temporary Discomfort
        • Unusual Levels of Temporary Discomfort
        • Risk of Permanent Damage
        • Certainty of Permanent Damage
      • Critical Appraisal Guidelines to Examine Protection of Human Rights in Studies
    • UNDERSTANDING INFORMED CONSENT
      • Essential Information for Consent
      • Comprehension of Consent Information
      • Competence to Give Consent
      • Voluntary Consent
      • Documentation of Informed Consent
        • Written Signed Consent Waived
        • Written Short Form Consent Documents
        • Formal Written Consent Document
        • Health Insurance Portability and Accountability Act Privacy Rule: Authorization for Research Uses and Disclosure
      • Critical Appraisal Guidelines to Examine Informed Consent in Studies
    • UNDERSTANDING INSTITUTIONAL REVIEW
      • Levels of Reviews Conducted by Institutional Review Boards
      • Influence of Health Insurance Portability and Accountability Act Privacy Rule on Institutional Review Boards
    • EXAMINING THE BENEFIT-RISK RATIO OF A STUDY
      • Critical Appraisal Guidelines for Examining the Ethical Aspects of Studies
    • UNDERSTANDING RESEARCH MISCONDUCT
      • Role of the Office of Research Integrity in Promoting the Conduct of Ethical Research
    • EXAMINING THE USE OF ANIMALS IN RESEARCH
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 5: Research Problems, Purposes, and Hypotheses
    • What Are Research Problems and Purposes?
    • IDENTIFYING THE PROBLEM AND PURPOSE IN QUANTITATIVE, QUALITATIVE, AND OUTCOMES STUDIES
      • Problems and Purposes in Types of Quantitative Studies
      • Problems and Purposes in Types of Qualitative Studies
      • Problems and Purposes in Outcomes Research
    • DETERMINING THE SIGNIFICANCE OF A STUDY PROBLEM AND PURPOSE
      • Influences Nursing Practice
      • Builds on Previous Research
      • Promotes Theory Testing or Development
      • Addresses Nursing Research Priorities
    • EXAMINING THE FEASIBILITY OF A PROBLEM AND PURPOSE
      • Researcher Expertise
      • Money Commitment
      • Availability of Subjects, Facilities, and Equipment
      • Ethical Considerations
    • EXAMINING RESEARCH OBJECTIVES, QUESTIONS, AND HYPOTHESES IN RESEARCH REPORTS
      • Research Objectives or Aims
      • Research Questions
      • Hypotheses
        • Types of Hypotheses
          • Associative versus causal hypotheses
          • Simple versus complex hypotheses
          • Nondirectional versus directional hypotheses
          • Statistical versus research hypotheses
        • Testable Hypothesis
    • UNDERSTANDING STUDY VARIABLES AND RESEARCH CONCEPTS
      • Types of Variables in Quantitative Research
        • Independent and Dependent Variables
        • Research Variables
        • Extraneous Variables
      • Conceptual and Operational Definitions of Variables in Quantitative Research
      • Research Concepts Investigated in Qualitative Research
      • Demographic Variables
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 6: Understanding and Critically Appraising the Literature Review
    • PURPOSE OF THE LITERATURE REVIEW
      • Purpose of the Literature Review in Quantitative Research
      • Purpose of the Literature Review in Qualitative Research
    • SOURCES INCLUDED IN A LITERATURE REVIEW
      • Types of Publications
      • Content of Publications
      • Quality of Sources
    • CRITICALLY APPRAISING LITERATURE REVIEWS
      • Critical Appraisal of a Literature Review in a Quantitative Study
      • Critical Appraisal of a Literature Review in a Qualitative Study
    • REVIEWING THE LITERATURE
      • Preparing to Review the Literature
        • Clarify the purpose of the literature review
        • Select electronic databases and search terms
      • Conducting the Literature Review
        • Search the selected databases
        • Use a table or other method to document the results of your search
        • Refine your Search
        • Review the abstracts to identify relevant studies
        • Obtain full-text copies of relevant articles
        • Ensure that information needed to cite the source is recorded
      • Processing the Literature
        • Read the articles
        • Appraise, analyze, and synthesize the literature
      • Writing the Review of the Literature
        • Develop an outline to organize the information from the review
        • Write each section of the review
        • Create the reference list
        • Check the review and the reference list
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 7: Understanding Theory and Research Frameworks
    • WHAT IS A THEORY?
    • UNDERSTANDING THE ELEMENTS OF THEORY
      • Concepts
      • Relational Statements
    • LEVELS OF THEORETICAL THINKING
      • Grand Nursing Theories
      • Middle Range and Practice Theories
      • Study Frameworks
    • EXAMPLES OF CRITICAL APPRAISAL
      • Framework from a Grand Nursing Theory
      • Framework Based on Middle Range Theory
      • Framework from a Tentative Theory
      • Framework for Physiological Study
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 8: Clarifying Quantitative Research Designs
    • IDENTIFYING DESIGNS USED IN NURSING STUDIES
    • DESCRIPTIVE DESIGNS
      • Typical Descriptive Design
      • Comparative Descriptive Design
    • CORRELATIONAL DESIGNS
      • Descriptive Correlational Design
      • Predictive Correlational Design
      • Model Testing Design
    • UNDERSTANDING CONCEPTS IMPORTANT TO CAUSALITY IN DESIGNS
      • Multicausality
      • Probability
      • Bias
      • Control
      • Manipulation
    • EXAMINING THE VALIDITY OF STUDIES
      • Statistical Conclusion Validity
        • Low Statistical Power
        • Reliability or Precision of Measurement Methods
        • Reliability of Intervention Implementation
        • Extraneous Variances in the Study Setting
      • Internal Validity
        • Subject Selection and Assignment to Groups
        • Subject Attrition
        • History
        • Maturation
      • Construct Validity
        • Inadequate Definitions of Constructs
        • Mono-operation Bias
        • Experimenter Expectancies (Rosenthal Effect)
      • External Validity
        • Interaction of Selection and Treatment
        • Interaction of Setting and Treatment
        • Interaction of History and Treatment
    • ELEMENTS OF DESIGNS EXAMINING CAUSALITY
      • Examining Interventions in Nursing Studies
      • Experimental and Control or Comparison Groups
    • QUASI-EXPERIMENTAL DESIGNS
      • Pretest and Post-test Designs with Comparison Group
    • EXPERIMENTAL DESIGNS
      • Classic Experimental Pretest and Post-test Designs with Experimental and Control Groups
      • Post-test-Only with Control Group Design
    • RANDOMIZED CONTROLLED TRIALS
    • INTRODUCTION TO MIXED-METHODS APPROACHES
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 9: Examining Populations and Samples in Research
    • UNDERSTANDING SAMPLING CONCEPTS
      • Populations and Elements
      • Sampling or Eligibility Criteria
    • REPRESENTATIVENESS OF A SAMPLE IN QUANTITATIVE AND OUTCOMES RESEARCH
      • Random and Systematic Variation of Subjects Values
      • Acceptance and Refusal Rates in Studies
      • Sample Attrition and Retention Rates in Studies
      • Sampling Frames
      • Sampling Methods or Plans
    • PROBABILITY SAMPLING METHODS
      • Simple Random Sampling
      • Stratified Random Sampling
      • Cluster Sampling
      • Systematic Sampling
    • NONPROBABILITY SAMPLING METHODS COMMONLY USED IN QUANTITATIVE RESEARCH
      • Convenience Sampling
      • Quota Sampling
    • SAMPLE SIZE IN QUANTITATIVE STUDIES
      • Effect Size
      • Types of Quantitative Studies
      • Number of Variables
      • Measurement Sensitivity
      • Data Analysis Techniques
    • SAMPLING IN QUALITATIVE RESEARCH
      • Purposeful or Purposive Sampling
      • Network Sampling
      • Theoretical Sampling
    • SAMPLE SIZE IN QUALITATIVE STUDIES
      • Scope of the Study
      • Nature of the Topic
      • Quality of the Information
      • Study Design
    • RESEARCH SETTINGS
      • Natural Setting
      • Partially Controlled Setting
      • Highly Controlled Setting
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 10: Clarifying Measurement and Data Collection in Quantitative Research
    • CONCEPTS OF MEASUREMENT THEORY
      • Directness of Measurement
      • Levels of Measurement
        • Nominal-Level Measurement
        • Ordinal-Level Measurement
        • Interval-Level Measurement
        • Ratio-Level Measurement
      • Measurement Error
      • Reliability
        • Reliability Testing
      • Validity
    • ACCURACY, PRECISION, AND ERROR OF PHYSIOLOGICAL MEASURES
      • Accuracy
      • Precision
      • Error
    • USE OF SENSITIVITY, SPECIFICITY, AND LIKELIHOOD RATIOS TO DETERMINE THE QUALITY OF DIAGNOSTIC AND SCREENING TESTS
      • Sensitivity and Specificity
      • Likelihood Ratios
    • MEASUREMENT STRATEGIES IN NURSING
      • Physiological Measures
      • Observational Measurement
      • Interviews
      • Questionnaires
      • Scales
        • Rating Scales
        • Likert Scale
        • Visual Analog Scales
    • DATA COLLECTION PROCESS
      • Recruitment of Study Participants
      • Consistency in Data Collection
      • Control in the Study Design
      • Studies Obtaining Data from Existing Databases
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 11: Understanding Statistics in Research
    • UNDERSTANDING THE ELEMENTS OF THE STATISTICAL ANALYSIS PROCESS
      • Management of Missing Data
      • Description of the Sample
      • Reliability of Measurement Methods
      • Exploratory Analyses
      • Inferential Statistical Analyses
      • ``Data Analysis
    • UNDERSTANDING THEORIES AND CONCEPTS OF THE STATISTICAL ANALYSIS PROCESS
      • Probability Theory
      • Decision Theory, Hypothesis Testing, and Level of Significance
      • Inference and Generalization
      • Normal Curve
      • Tailedness
      • Type I and Type II Errors
      • Power: Controlling the Risk of a Type II Error
      • Degrees of Freedom
    • USING STATISTICS TO DESCRIBE
      • Frequency Distributions
        • Ungrouped Frequency Distributions
        • Grouped Frequency Distributions
        • Percentage Distributions
      • Measures of Central Tendency
        • Mode
        • Median
        • Mean
      • Measures of Dispersion
        • Range
        • Variance
        • Standard Deviation
        • Confidence Interval
        • Standardized Scores
        • Scatterplots
      • Understanding Descriptive Statistical Results
    • DETERMINING THE APPROPRIATENESS OF INFERENTIAL STATISTICS IN STUDIES
      • Critical Appraisal Guidelines for Inferential Statistical Analyses
    • USING STATISTICS TO EXAMINE RELATIONSHIPS
      • Pearson Product-Moment Correlation
        • Interpreting Pearson Correlation Analysis Results
        • Testing the Significance of a Correlation Coefficient
      • Factor Analysis
    • USING STATISTICS TO PREDICT OUTCOMES
      • Regression Analysis
        • Interpreting Results
    • USING STATISTICS TO EXAMINE DIFFERENCES
      • Chi-Square Test of Independence
        • Interpreting Results
      • t-Test
        • Interpreting Results
      • Analysis of Variance (ANOVA)
        • Interpreting Results
      • Analysis of Covariance (ANCOVA)
    • INTERPRETING RESEARCH OUTCOMES
      • Types of Results
        • Significant and Predicted Results
        • Nonsignificant Results
        • Significant and Unpredicted Results
        • Mixed Results
        • Unexpected Results
      • Findings
      • Exploring the Significance of Findings
      • Clinical Importance of Findings
      • Limitations
      • Conclusions
      • Generalizing the Findings
      • Implications for Nursing
      • Recommendations for Further Studies
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 12: Critical Appraisal of Quantitative and Qualitative Research for Nursing Practice
    • WHEN ARE CRITICAL APPRAISALS OF STUDIES IMPLEMENTED IN NURSING?
      • Students' Critical Appraisal of Studies
      • Critical Appraisal of Studies by Practicing Nurses, Nurse Educators, and Researchers
      • Critical Appraisal of Research Following Presentation and Publication
      • Critical Appraisal of Research for Presentation and Publication
      • Critical Appraisal of Research Proposals
    • WHAT ARE THE KEY PRINCIPLES FOR CONDUCTING INTELLECTUAL CRITICAL APPRAISALS OF QUANTITATIVE AND QUALITATIVE STUDIES?
    • UNDERSTANDING THE QUANTITATIVE RESEARCH CRITICAL APPRAISAL PROCESS
      • Step 1: Identifying the Steps of the Research Process in Studies
        • Guidelines for Identifying the Steps of the Research Process in Studies
      • Step 2: Determining the Strengths and Weaknesses in Studies
        • Guidelines for Determining the Strengths and Weaknesses in Studies
      • Step 3: Evaluating the Credibility and Meaning of Study Findings
        • Guidelines for Evaluating the Credibility and Meaning of Study Findings
    • EXAMPLE OF A CRITICAL APPRAISAL OF A QUANTITATIVE STUDY
    • UNDERSTANDING THE QUALITATIVE RESEARCH CRITICAL APPRAISAL PROCESS
      • Step 1: Identifying the Components of the Qualitative Research Process in Studies
        • Guidelines for Identifying the Components of the Research Process in Qualitative Studies
        • Guidelines for Identifying the Components of a Qualitative Study
      • Step 2: Determining the Strengths and Weaknesses in Studies
        • Guidelines for Determining the Strengths and Weaknesses in Studies
      • Step 3: Evaluating the Trustworthiness and Meaning of Study Findings
        • Guidelines for Evaluating the Trustworthiness and Meaning of Study Findings
    • EXAMPLE OF A CRITICAL APPRAISAL OF A QUALITATIVE STUDY
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 13: Building an Evidence-Based Nursing Practice
    • BENEFITS AND BARRIERS RELATED TO EVIDENCE-BASED NURSING PRACTICE
      • Benefits of Evidence-Based Nursing Practice
        • Force 6: Quality Care
          • ``Research and Evidence-Based Practice
      • Barriers to Evidence-Based Nursing Practice
    • SEARCHING FOR EVIDENCE-BASED SOURCES
    • CRITICALLY APPRAISING RESEARCH SYNTHESES
      • Critically Appraising Systematic Reviews
        • Step 1
          • Did the title indicate if a systematic review or meta-analysis was conducted?
        • Step 2
          • Did the abstract include a structured summary of the research synthesis?
        • Step 3
          • Was a significant, clear clinical question developed to direct the research synthesis?
        • Step 4
          • Were the purpose and objectives or aims of the review expressed?
        • Step 5
          • Was the literature search criteria clearly identified?
        • Step 6
          • Was a comprehensive, systematic search of the research literature conducted?
        • Step 7
          • Was publication bias addressed?
        • Step 8
          • Was the process for selecting the studies for review detailed?
        • Step 9
          • Were key elements of the studies presented?
        • Step 10
          • Were the studies critically appraised?
        • Step 11
          • Was a meta-analysis conducted as part of the systematic review?
        • Step 12
          • Were the results of the review clearly presented?
        • Step 13
          • Did the report conclude with a clear discussion section?
          • Implications for practice
        • Step 14
          • Was a clear concise report developed for publication?
      • Critically Appraising Meta-Analyses
        • Clinical Question for a Meta-Analysis
        • Purpose and Questions to Direct a Meta-Analysis
        • Search Criteria and Strategies for Meta-Analyses
          • Primary Study Search Strategies
        • Possible Biases for Meta-Analyses and Systematic Reviews
        • Results of Meta-Analysis for Continuous Outcomes
        • Results of Meta-Analysis for Dichotomous Outcomes
      • Critically Appraising Meta-Syntheses
        • Framing for the Meta-Synthesis
        • Searching the Literature and Selecting Sources
        • Appraisal of Studies and Analysis of Data
        • Discussion of Meta-Synthesis Findings
      • Critically Appraising Mixed-Methods Systematic Reviews
    • DEVELOPING CLINICAL QUESTIONS TO IDENTIFY EXISTING RESEARCH-BASED EVIDENCE FOR USE IN PRACTICE
    • MODELS TO PROMOTE EVIDENCE-BASED PRACTICE IN NURSING
      • Stetler Model of Research Utilization to Facilitate Evidence-Based Practice
        • Phase I: Preparation
        • Phase II: Validation
        • Phase III: Comparative Evaluation/Decision Making
        • Phase IV: Translation/Application
        • Phase V: Evaluation
      • Iowa Model of Evidence-Based Practice
      • Application of the Iowa Model of Evidence-Based Practice
    • IMPLEMENTING EVIDENCE-BASED GUIDELINES IN PRACTICE
      • History of the Development of Evidence-Based Guidelines
      • National Guideline Clearinghouse Resources
      • Implementing Evidence-Based Guidelines for Management of Hypertension in Practice
    • INTRODUCTION TO EVIDENCE-BASED PRACTICE CENTERS
    • INTRODUCTION TO TRANSLATIONAL RESEARCH
    • KEY CONCEPTS
    • REFERENCES
  • Chapter 14: Outcomes Research
    • THEORETICAL BASIS OF OUTCOMES RESEARCH
    • NURSING-SENSITIVE OUTCOMES
    • ORIGINS OF OUTCOMES AND PERFORMANCE MONITORING
    • FEDERAL GOVERNMENT INVOLVEMENT IN OUTCOMES RESEARCH
      • Agency for Healthcare Research and Quality (AHRQ)
      • American Recovery and Reinvestment Act
      • National Quality Forum
      • National Database of Nursing Quality Indicators
      • Oncology Nursing Society
    • ADVANCED PRACTICE NURSING OUTCOMES RESEARCH
    • OUTCOMES RESEARCH AND NURSING PRACTICE
      • Evaluating Outcomes of Care
      • Evaluating Structure of Care
      • Evaluating Process of Care
        • Standards of Care
        • Practice Styles, Practice Pattern, and Evidence-Based Practice
    • METHODOLOGIES FOR OUTCOMES STUDIES
      • Samples and Sampling
        • Large Databases as Sample Sources
      • Study Designs
        • Prospective Cohort Studies
        • Retrospective Cohort Studies
        • Population-Based Studies
        • Economic Studies
        • Ethical Studies
      • Measurement Methods
    • STATISTICAL METHODS FOR OUTCOMES STUDIES
      • Analysis of Change
      • Analysis of Improvement
    • CRITICAL APPRAISAL OF OUTCOMES STUDIES
      • Questions Guiding the Critical Appraisal of Outcomes Studies
        • Are the results valid?
        • What are the results?
        • In a study of an outcome such as health-related quality of life (HRQL):
        • How can I apply the results to patient care?
      • Example Critical Appraisal of an Outcomes Study
    • KEY CONCEPTS
    • REFERENCES
  • Glossary
  • Index
  • Inside Back Cover