Analyzing Published Research

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NURSING RESEARCH READING, USING, AND CREATING EVIDENCE

FOURTH EDITION

JANET HOUSER, PHD, RN Provost and Professor Rueckert-Hartman College for Health Professions Regis University Denver, Colorado

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Library of Congress Cataloging-in-Publication Data Names: Houser, Janet, 1954- author. Title: Nursing research : reading, using, and creating evidence / Janet Houser. Description: Fourth edition. | Burlington, Massachusetts : Jones & Bartlett Learning, [2018] | Includes bibliographical references and index. Identifiers: LCCN 2016038194 | ISBN 9781284110043 Subjects: | MESH: Clinical Nursing Research--methods | Evidence-Based

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Contents Preface Acknowledgments Contributors About the Author

Part I: An Introduction to Research

1 The Importance of Research as Evidence in Nursing Research as Evidence for Nursing Practice

What Is Nursing Research?

Research: A Fundamental Nursing Skill

The Evolution of Research in Nursing

Contemporary Nursing Research Roles

Research Versus Problem Solving

Research as Evidence in Nursing Practice

Evidence-Based Practice

The Importance of Evidence-Based Practice in Nursing

How Can Evidence Be Used in Health Care?

Strategies for Implementing Evidence-Based Practice

Strategies for Overcoming Barriers

Reading Research for Evidence-Based Practice

Using Research in Evidence-Based Practice

Creating Evidence for Practice

Future Directions for Nursing Research

Summary of Key Concepts

For More Depth and Detail

References

2 The Research Process and Ways of Knowing Introduction

The Research Process

Classification of Research by Philosophical Assumptions About the Nature of the World

Choosing a Design

Classifications of Research by the Intent of the Researcher

Classifications of Research by the Nature of the Design

Classifications of Research by the Time Dimension

Reading Research for Evidence-Based Practice

Using Research in Evidence-Based Practice

Creating Evidence for Practice

Summary of Key Concepts

For More Depth and Detail

References

3 Ethical and Legal Considerations in Research Introduction

Learning from the Past, Protecting the Future

International Guides for the Researcher

National Guidelines for the Nurse Researcher

The Ethical Researcher

Legal and Regulatory Guidelines for Conducting Research

Institutional Review Boards

Research Involving Animals

Research Misconduct

The HIPAA Privacy Rule

Reading Research for Evidence-Based Practice

Using Research in Nursing Practice

Creating Evidence for Practice

Summary of Key Concepts

For More Depth and Detail

References

Part II: Planning for Research

4 Finding Problems and Writing Questions Introduction

Finding and Developing Research Problems

Developing the Research Question

Reading Research for Evidence-Based Practice

Using Research in Evidence-Based Practice

Creating Evidence for Practice

Summary of Key Concepts

For More Depth and Detail

References

5 The Successful Literature Review An Introduction to the Literature Review

Purpose, Importance, and Scope of the Literature Review

Types of Literature Used in the Review

Searching for the Evidence in a Research Problem

Competencies for Information Literacy

Reading the Literature Review Section

Using Evidence-Based Literature in Nursing Practice

Creating a Strong Literature Review

Summary of Key Concepts

For More Depth and Detail

References

6 Selecting an Appropriate Research Design Introduction

What Is a Design?

The Basis for Design Selection

The Design Decisions

Reading Research for Evidence-Based Practice

Using Research in Evidence-Based Practice

Creating Evidence for Practice

Summary of Key Concepts

For More Depth and Detail

References

Part III: Research Process

7 The Sampling Strategy Introduction

Selection Strategy: How Were the Subjects Chosen?

The Sample Selection Strategy

Reading the Sampling Section of a Research Study

Using Research as Evidence for Practice

Creating an Adequate Sampling Strategy

Summary of Key Concepts

For More Depth and Detail

References

8 Measurement and Data Collection Introduction

Measurement

The Measurement Strategy

Strategies to Minimize Measurement Error

Collecting Data Using Instruments

Data Management Procedures

Reading About Measurement and Data Collection

Using Measurements from a Research Study

Creating Measures and Collecting Data

Summary of Key Concepts

References

9 Enhancing the Validity of Research Introduction

Minimizing Threats to Internal Validity

Factors That Jeopardize Internal Validity

Factors That Jeopardize External Validity

Balancing Internal and External Validity

Trustworthiness in Qualitative Research

Strategies to Promote the Validity of Qualitative Research

Reading a Research Study to Determine Validity

Using Valid Studies as Evidence for Nursing Practice

Creating a Valid Research Study

Summary of Key Concepts

For More Depth and Detail

References

Part IV: Research That Describes Populations

10 Descriptive Research Questions and Procedures Introduction

Descriptive Research Studies

Characteristics of a Descriptive Design

Describing Groups Using Surveys

Describing Groups Relative to Time

Describing the Responses of Single Subjects

Designs That Describe Relationships

Reading Descriptive Research

Using Descriptive Research in Evidence-Based Nursing Practice

Creating Descriptive Research

Summary of Key Concepts

References

11 Summarizing and Reporting Descriptive Data Introduction

An Overview of Descriptive Data Analysis

Understanding Levels of Measurement

Identifying Shape and Distribution

Describing the Center and Spread

Common Errors in Summarizing Data

Reading the Descriptive Data Section in a Research Study

Using Descriptive Data Analysis in Practice

Creating Descriptive Data Summaries for a Research Study

Reporting Descriptive Results

Summary of Key Concepts

References

Part V: Studies that Measure Effectiveness

12 Quantitative Questions and Procedures Introduction

Quantitative Research Questions

Characteristics of a Quantitative Design

The Gold Standard: Experimental Design

More Common: Quasi-Experimental Designs

Designs That Focus on Intact Groups

Time-Series Designs

Reading Quantitative Research

Using Quantitative Research in Evidence-Based Nursing Practice

Generalizing the Results of Quantitative Studies

Creating Quantitative Research

Summary of Key Concepts

References

13 Analysis and Reporting of Quantitative Data Introduction

Some General Rules of Quantitative Analysis

Types of Quantitative Analysis

An Overview of Quantitative Analysis

Selecting the Appropriate Quantitative Test

Reading the Analysis Section of the Research Report

Using Quantitative Results as Evidence for Practice

Creating a Quantitative Analysis

Summary of Key Concepts

References

Part VI: Research That Describes the Meaning of an Experience

14 Qualitative Research Questions and Procedures An Introduction to Qualitative Research

Characteristics of Qualitative Research Methods

Enhancing the Trustworthiness of Qualitative Studies

Classifications of Qualitative Traditions

Reading Qualitative Research Studies

Using Qualitative Research Studies as Evidence

Creating Qualitative Evidence

Summary of Key Concepts

References

15 Analyzing and Reporting Qualitative Results Introduction to Qualitative Analysis

The Qualitative Analysis Process

Management and Organization of Data

Software for Qualitative Analysis

Reliability and Validity: The Qualitative Version

Reporting Qualitative Results

Reading the Qualitative Analysis Section of a Report

Using Qualitative Analysis in Nursing Practice

Creating Qualitative Analyses

Summary of Key Concepts

References

Part VII: Research Translation

16 Translating Research into Practice Introduction

The Nurse’s Role in Knowledge Translation

Identifying Problems for Knowledge Translation

Communicating Research Findings

Finding and Aggregating Evidence

Models for Translating Research into Practice

Summary of Key Concepts

References

Glossary

Index

The Pedagogy Nursing Research: Reading, Using, and Creating Evidence, Fourth Edition demonstrates how to use research as evidence for successful nursing practice. Fully updated and revised, this readerfriendly new edition provides students with a fundamental understanding of how to appraise and utilize research, translating it into actionable guidelines for practice. Organized around the different types of research that can be used in evidence-based practice, it addresses contemporary methods including the use of technology in data collection, advice for culturally competent research, and suggestions for accessing hard-to-reach subjects. Additionally, it explores both quantitative and qualitative traditions and encourages students to read, use, and participate in the research process. The pedagogical aids that appear in most chapters include the following:

Preface This nursing research text is based on the idea that research is essential for nurses as evidence for practice. Its contents are intended to be relevant for nursing students, and practicing nurses who must apply evidence to practice. All nurses should be able to read research, determine how to use it appropriately in their practice, and participate in the research process in some way during their careers as professionals. This text is intended to support all these efforts.

Evidence-based practice is one of the most exciting trends in nursing practice to emerge in decades. However, its integration into daily practice requires a solid understanding of the foundations of research design, validity, and application. This text is intended as a reader-friendly approach to a complex topic so that beginners can grasp the fundamentals of appraising research, experienced nurses can use research in practice, and practicing nurses can gain skills to create bedside research projects or participate effectively on research teams.

This text is presented in an uncluttered, straightforward manner. Although it uses many bulleted lists to make the material visually interesting, the sidebars, figures, and tables are limited to those that illustrate truly important concepts. This format allows the reader to grasp the information quickly and to navigate the text efficiently. Margin notes provide definitions of new terms when they first appear, and the Gray Matter features offer information about key concepts that are of particular importance.

This text differs in its approach from traditional texts in that it does not focus primarily on interpreting inferential research; rather, it seeks to impart a fundamental understanding of all types of research that may be used as evidence. It adds depth by considering the use of qualitative research in nursing practice—a natural fit with this holistic profession. This text also addresses contemporary concerns for today’s nurses, including ethical and legal issues. Although both ethics and legal issues are mentioned in many research texts, a full chapter is devoted to these topics in this text so that the intricacies of these issues can be thoroughly considered.

The integrated discussion of both the quantitative and the qualitative traditions is another unique facet of this text’s coverage of the research process. Most nurse researchers have learned to appreciate the need to consider all paradigms when approaching a research question; separating the two approaches when discussing the fundamental interests of researchers results in a polarized view. Intuitively, nurses know that the lines between quantitative

and qualitative designs are not always so clear in practice and that they should consider multiple ways of knowing when evaluating research questions. The planning process covered here helps the novice researcher consider the requirements of both approaches in the context of sampling, measurement, validity, and other crucial issues they share. Detailed descriptions of the procedures for each type of design are given attention in separate chapters.

The chapters are organized around the types of research processes that make up the evidence base for practice. The first section of the text provides information that is applicable to all research traditions, whether descriptive, quantitative, or qualitative. Part I provides an overview of issues relevant to all researchers: understanding the way research and practice are related, the ways that knowledge is generated, and legal and ethical considerations. Part II describes the processes that go into planning research. The chapters in Part III consider the various decisions that must be made in each phase of the research process.

The evidence generated by descriptive, survey, and qualitative designs is placed in the context of both the definition of evidence-based practice and application in practice guidelines. In Parts IV, V, and VI, each major classification of research is explored in depth through review of available designs, guidelines for methods and procedures, and discussion of appropriate analytic processes. Brief examples of each type of research are provided, along with notes explaining the features demonstrated in each case in point. Finally, Part VII details the models and processes used to translate research into clinical practice.

Many chapters begin with a feature called “Voices from the Field” that relates a real-life story of a nurse’s experience with the research process, illustrating the way that the material covered in that chapter might come to life. The main content for each chapter is broken into five parts:

A thorough review of the topic under consideration is presented first. This review lays out the fundamental knowledge related to the topic. Next, the nurse isa guided to consider the aspects of a study that should be appraised when reading research. All nurses—regardless of their experience—should be able to read research critically and apply it appropriately to practice, and the second section of each chapter addresses this skill. Added features include advice on where to look for the key elements of a research paper, the wording that might be used to describe them, and specific things to look for during the evaluation process. Evaluation checklists support this process. The third section of the chapter focuses on using research in practice. This section supports the nurse in determining if and how research findings might be used in his or her practice.

The fourth section is intended for nurses who may be involved with teams that are charged with creating research or who may plan bedside research projects to improve practice. This section gives practical advice and direction about the design and conduct of a realistic, focused nursing research project. The final section of each chapter contains summary points and a critical appraisal exercise so that the nurse can immediately apply the chapter concepts to a real research report.

All of these features are intended to help the reader gain a comprehensive view of the research process as it is used to provide evidence for professional nursing practice. The use of this text as a supportive resource for learning and for ongoing reference in clinical practice has been integrated into the design of each element of the text. The goal is to stimulate nurses to read, use, and participate in the process of improving nursing practice through the systematic use of evidence. Accomplishing this goal improves the profession for all of us.

Acknowledgments It is a bit misleading to conclude that a text is produced solely by the person whose name appears on the cover. Help and support are needed from many people on both professional and personal fronts to complete a project of this size. The help of editorial staff is always welcome; advice from Amanda Martin was invaluable in merging the interests of writing with those of producing a book that others will want to read. I appreciate Amanda Clerkin’s calm and steady approach after our sixth manuscript together, and I’ve learned a lot from reading Jill Hobbs’s edits, which I must begrudgingly admit make my writing much better.

My family—my husband, Floyd; my sisters, Anne and Ande; my niece, Stef; and mini-me, Amanda—provided me with enough encouragement to keep going, even as they reminded me there is life beyond the pages of a book.

I must thank Regis University profusely for providing me with inspirational colleagues and a place that supports my work. Pat Ladewig, as always, provided pragmatic advice and guidance from her impressive experience publishing her own texts. My contributors and reviewers each provided a unique viewpoint and helped me discover the best way to ensure that students “get it.”

Writing always makes me realize how much I miss my mom, Marty, who encouraged me to publish from the time she surreptitiously sent one of my poems to Highlights magazine when I was 9 years old. She was proud of that poem, framed the issue, and had my grandmother embroider it on a pillow. Seeing this book in print would have impressed her only slightly more, but I know she’s smiling.

Contributors Michael Cahill, MS, CPHQ Parker Adventist Hospital Parker, Colorado Summarizing and Reporting Descriptive Data

Sheila Carlon, PhD, RHIA, FAHIMA Regis University Denver, Colorado Ethical and Legal Considerations in Research

Phyllis Graham-Dickerson, PhD, RN, CNS Regis University Denver, Colorado Qualitative Research Questions and Procedures Analyzing and Reporting Qualitative Results

LeeAnn Hanna, PhD, RN, CPHQ, FNAHQ HCA, TriStar Centennial Medical Center Nashville, Tennessee Finding Problems and Writing Questions

Kimberly O’Neill, MS, MLIS Dayton Memorial Library, Regis University Denver, Colorado The Successful Literature Search

About the Author

Janet Houser, PhD, RN

Regis University

Dr. Janet Houser is currently Provost at Regis University in Denver, Colorado. Prior to her appointment, she was Dean of the Rueckert-Hartman College for Health Professions and the Vice Provost for Resource Planning.

Dr. Houser has a BSN, an MN in Maternal-Child Health, an MS in healthcare administration, and a PhD in applied statistics and research methods. She has taught nurses, administrators, pharmacists, and physical therapy students from undergraduate through doctoral level, primarily in the subjects of research methods, biostatistics, and quantitative methods. Previous to her position as Dean, Dr. Houser was faculty and Associate Dean for Research and Scholarship.

Dr. Houser spent 20 years in healthcare administration with the Mercy Health System. Her last position was as Regional Director for Professional Practice for Mercy Health Partners in Cincinnati, Ohio, where she was responsible for professional practice and clinical research in 29 facilities.

Dr. Houser has published five books, Clinical Research in Practice: A Guide for the Bedside Scientist, Nursing Research: Reading, Using, and Creating Evidence, which is in its fourth edition, and Evidence-Based Practice: An Implementation Guide. She has more than 30 peer-reviewed publications in journals and has presented her research at regional, national, and international conferences.

Part I: An Introduction to Research 1 The Importance of Research as Evidence in Nursing 2 The Research Process and Ways of Knowing 3 Ethical and Legal Considerations in Research

Chapter 1: The Importance of Research as Evidence in Nursing

CHAPTER OBJECTIVES The study of this chapter will help the learner to

Define nursing research and discuss how research is used in nursing practice. Describe the evolution of nursing research. Investigate the roles that nurses play in research processes. Contrast research and other types of problem solving. Explore how research is used as evidence guiding the practice of nursing. Read research and appraise the credibility of the journal, authors, and publication process.

KEY TERMS Blinded

Evidence-based practice

Evidence-based practice guideline

External validity

Journal club

Magnet status

National Institute of Nursing Research (NINR)

Nursing process

Nursing research

Outcomes measurement

Peer review

Principal investigator

Quality improvement

Randomized controlled trial

Replication

Systematic review

Research as Evidence for Nursing Practice The practice of nursing is deeply rooted in nursing knowledge, and nursing knowledge is generated and disseminated through reading, using, and creating nursing research. Professional nurses rely on research findings to inform their practice decisions; they use critical thinking to apply research directly to specific patient care situations. The research process allows nurses to ask and answer questions systematically that will ensure that their decisions are based on sound science and rigorous inquiry. Nursing research helps nurses in a variety of settings answer questions about patient care, education, and administration. It ensures that practices are based on evidence, rather than eloquence or tradition.

VOICES FROM THE FIELD I was working as the clinical nurse specialist in a busy surgical intensive care unit (ICU) when we received a critically ill patient. He was fresh from cardiac surgery and quite unstable; he needed multiple drugs and an intra-aortic balloon pump just to maintain his perfusion status. The patient was so sick that we were not able to place him on a special bed for pressure relief. For the first 24 hours, we were so busy trying to keep him alive that we did not even get a chance to turn him.

Approximately 36 hours into his ICU admission, he was stable enough to place on a low-air-loss mattress for pressure-ulcer prevention. When we were finally able to turn him, we noted he had a small stage II pressure ulcer on his coccyx. Despite the treatments that we used, the pressure ulcer evolved into a full-thickness wound. The patient recovered from his cardiac surgical procedure but, unfortunately, required surgeries and skin grafts to close the pressure ulcer wound.

The experience I had with this patient prompted me to review the evidence-based practice (EBP) guidelines we had in place to prevent pressure ulcers in critically ill patients. I wanted to make sure we could prevent this kind of incident from happening again, but I had a lot of questions. Could we preventively place high-risk patients on low-air- loss mattresses while they were still in the perioperative service? Did we even know which patients were at risk for pressure ulcers? Which assessment tools did nurses use to assess the patient’s risk? When a high-risk patient was identified, which interventions did the nurses use to prevent pressure ulcers? How were the ulcers treated once they appeared?

I was fortunate that my chief nursing officer (CNO) was a strong advocate for EBP, and she encouraged me to initiate an EBP review of pressure ulcer prevention and treatment. Specifically, I wanted to find out which nursing interventions were supported by research evidence when we were trying to prevent pressure ulcers in the surgical ICU. As

part of my review, I contacted other inpatient units at the hospital to determine what they were doing.

I discovered that the surgical ICU was no different from the other inpatient units in this regard: There was no standard, evidence-based nursing practice for pressure ulcer prevention. Units were not consistently using the same skin assessment tools, so it was difficult to objectively communicate risk from one unit to another. The tools we were using were not necessarily based on research. It was clear that we needed to identify the best available evidence and devise a protocol.

We started by establishing an evidence-based skin care council for the hospital. This team consisted of bedside nurses from all inpatient units and the perioperative service. Initially the council reviewed the hospital’s current nursing skin assessment forms, and we conducted a review of the literature on pressure ulcer prevention and interventions. We discovered the Agency for Healthcare Research and Quality (AHRQ) guidelines on pressure ulcer prevention and treatment—a key source of evidence for healthcare practices.

Over the course of the next year, we revised our nursing policy and procedure, incorporating the AHRQ evidence into a treatment guideline. This guideline included a procedure for skin assessment and nursing documentation, and pressure ulcer assessment and treatment decision algorithms. We reviewed skin-care products and narrowed down the list of products to those that were supported by evidence. One algorithm helped staff make selections between products that maximized prevention and treatment. Another algorithm guided nurses in the use of therapeutic surfaces (e.g., low-air-loss mattresses) to prevent pressure ulcers. To monitor our progress, we began quarterly pressure ulcer prevalence studies. As part of the implementation, we scheduled a skin-care seminar featuring a national expert on skin care.

At the beginning of our EBP skin-care journey, our facility’s pressure ulcer prevalence was 9%. Since implementing our EBP skin-care initiatives, it has dropped by two thirds. The EBP skin-care council continues to be active in our hospital. We meet monthly to seek out the best evidence to guide skin- and wound-care product decisions, practice guidelines, protocols, and policies. My initial search for a solution—based on my experience with one patient—led to improvements in practice that have benefited many patients since then.

Mary Beth Flynn Makic, PhD, RN

What Is Nursing Research? Nursing research is a systematic process of inquiry that uses rigorous guidelines to produce unbiased, trustworthy answers to questions about

nursing practice. Research is used as evidence in the evaluation and determination of best nursing practices. Original nursing research aims to generate new knowledge to inform the practice of nursing. More specifically, nurses may use research for the following purposes:

Synthesize the findings of others into a coherent guide for practice Explore and describe phenomena that affect health Find solutions to existing and emerging problems Test traditional approaches to patient care for continued relevance and effectiveness

Nursing research: A systematic process of inquiry that uses rigorous guidelines to produce unbiased, trustworthy answers to questions about nursing practice.

Nurse researchers use a variety of methods to generate new knowledge or summarize existing study results. They may measure observable characteristics, solicit perceptions directly from clients, assess words and phrases for underlying meaning, or analyze a group of study findings in aggregate. Nurse researchers have almost limitless options for research design. Moreover, they may assume a variety of roles, ranging from primary investigator for a large, multisite trial to staff nurse in a bedside science project. Nevertheless, the goal is always the same: to generate new knowledge that can be applied to improve nursing practice.

Regardless of the design, research is a rigorous endeavor that is subject to peer review and replication. These two characteristics are essential to ensure that research is unbiased and applicable to the real world. A study is subjected to peer review when experts in the field evaluate the quality of the research and determine whether it warrants presentation at a conference or publication in a professional journal. These reviews are generally blinded, meaning the reviewer remains unaware of the researcher’s identity. In blinded peer review, a research report is subjected to appraisal by a neutral party who is unassociated with the research and unaware of the report’s authorship. Reviewers determine whether the study process and outcome are of acceptable quality for communication to the broader professional community. Replication ensures that findings can be duplicated in different populations and at different times. This characteristic provides the nurse with confidence that the findings are not limited to a single sample, so that study outcomes will likely be similar in other patient populations.

Peer review: The process of subjecting research to the appraisal of a neutral third party. Common processes of peer review include selecting

research for conferences and evaluating research manuscripts for publication.

Blinded: A type of review in which the peer reviewer is unaware of the author’s identity, so personal influence is avoided.

Replication: Repeating a specific study in detail on a different sample. When a study has been replicated several times and similar results are found, the evidence can be used with more confidence.

Research: A Fundamental Nursing Skill Although many students and practitioners of nursing consider research to be the purview of academics and graduate students, it is actually fundamental to professional nursing practice. There are many reasons why research is critical for the nurse in any role. Nursing is a profession, and along with advanced education and self-regulation, research is one of the central tenets that defines a profession. For nurses to function on healthcare teams as colleagues with therapists, physicians, and other caregivers, they must speak the language of science and use the best available research evidence as the basis for collaborating in planning patient care.

As professionals, nurses are accountable for the outcomes they achieve and the effectiveness of interventions that they apply and recommend to patients. Their accountability is based on a solid understanding and evaluation of the best available evidence as the foundation for decision making and patient counseling. In current healthcare practice, access, cost, and patient safety are all areas that clearly benefit from nursing research.

Consumer demands also require that nurses be held accountable for their practice. Today’s consumers and their families are often well informed about the evidence that reveals the effectiveness of care. The Internet has given consumers unprecedented access to health information—some of it questionable, but much of it of high quality—that enables them to evaluate the basis for their own healthcare decisions.

In 2011, the Institute of Medicine issued a seminal report on the future of nursing. In this report, it set a goal that, by 2020, 90% of all clinical decisions would be based on research evidence. Given that the current estimated rate falls far short of that goal, there is an urgent need for healthcare leaders and clinicians to collaborate in designing and implementing effective strategies for research integration into clinical care. In particular, there is a need to enhance the rigor of nursing research studies, and to translate evidence into practice- friendly forms that nurses can use in daily care delivery.

Many nursing organizations are in the process of pursuing or maintaining Magnet status, which requires the organization to contribute to new knowledge and innovation in nursing care. Wilson and others (2015) found other benefits from an organization achieving Magnet status: Nurses in Magnet facilities express greater interest in using evidence in practice, report fewer barriers to implementation of EBP, and used EBP with more frequency than nurses in non-Magnet facilities. Integration of evidence into daily practice requires both resources and formalized processes; these assets must be evident and useful in a Magnet organization. To maintain Magnet status, hospitals must show quality outcomes, best practices, and nursing excellence —all of which require development and dissemination of new knowledge (Messmer & Turkel, 2011).

Magnet status: A designation for organizations that have characteristics that make them attractive to nurses as workplaces.

The Evolution of Research in Nursing Nursing is a relatively young field compared to fields such as philosophy or physics that boast hundreds of years of historical study. Moreover, nursing has not always relied on profession-specific research as a basis for practice. However, as the contemporary nursing literature makes clear, research is taking on fundamental importance as a source of evidence for practice.

More than 150 years ago, Florence Nightingale introduced the concept of scientific inquiry as a basis for nursing practice. Nightingale’s work focused on collecting information about factors that affected soldier mortality and morbidity during the Crimean War. Armed with these scientific data, she was able to instigate changes in nursing practice. Indeed, her work was so impressive that she was inducted into the Statistical Society of London.

The years following Nightingale’s breakthroughs were marked by relatively little scientific work in nursing, likely because nursing education was accomplished through apprenticeship rather than scholarly work. As more nursing education moved into university settings in the 1950s, however, research took on greater prominence as a key nursing activity. Journals were founded both in the United States and internationally that focused exclusively on publishing nursing research. More outlets for the publication of nursing research were established in the 1970s and 1980s, leading to the communication of research findings to a broader audience. The creation of the National Center for Research for Nursing within the National Institutes of Health (NIH) in 1986 was a seminal step in recognizing the importance of nursing research. In 1993, the center was given full institute status as the National Institute of Nursing Research (NINR). This move put nursing research on an even footing with medical research and the other health sciences, ensuring financial support and a national audience for disciplined

inquiry in the field. The NINR and other national agencies guide the overarching research agenda that focuses nursing research on professional priorities. The mission of the NINR is to support and conduct clinical and basic research on health and illness so as to build the scientific foundation for clinical practice. The ultimate goal is to improve the health of individuals, families, communities, and populations through evidence-based nursing practices (NINR, 2013).

National Institute of Nursing Research (NINR): A federal agency responsible for the support of nursing research by establishing a national research agenda, funding grants and research awards, and providing training.

In the 1980s and 1990s, leaders in nursing research met periodically at the Conference on Research Priorities in Nursing Science (CORP) to identify research priorities for the nursing profession. These priorities were established as 5-year agendas. In the 1990s, advances in nursing research were coming so quickly that a more flexible approach was required. The NINR recognized that the issues facing nursing science had evolved as health care had evolved, becoming more complex. The process that the NINR currently uses to develop its research priorities is both expansive and inclusive. The formal process begins with the identification of broad areas of health in which there is the greatest need, and identification of the areas of science in which nursing research could achieve the greatest impact. To maximize the amount and diversity of input into the research priorities, “Scientific Consultation Meetings” are held to bring together individuals from academia, government, industry, and patient advocacy. Experts in science and health care are consulted, and panels of experts discuss current health and research challenges as well as future strategies for research and education. These meetings focus on topics crucial to NINR’s future, including the following:

Preparing the next generation of nurse scientists Advancing nursing science through comparative effectiveness research Supporting research on end-of-life care Forecasting future needs for health promotion and prevention of disease Identification of emerging needs in the science of nursing (NINR, 2011)

Some examples of recent NINR nursing research priorities appear in Table 1.1.

GRAY MATTER Research is critical in nursing for the following reasons:

The use of research is inherent to the definition of a profession. Nurses are accountable for outcomes.

Consumers are demanding evidence-based care.

Table 1.1 National Institute of Nursing Research’s Proposed Strategic Research Investment Areas

Objective Examples

Enhance health promotion and disease prevention

Develop innovative behavioral interventions Study the behavior of systems that can promote personalized interventions Improve the ways in which individuals change health behaviors Develop models of lifelong health promotion Translate scientific advances into motivation for health behavior change Incorporate partnerships between community agencies and others in healthcare research

Improve quality of life by managing symptoms of acute and chronic illness

Improve knowledge of the biological and genomic mechanisms associated with symptoms Design interventions to improve the assessment and management of symptoms over the course of a disease Study the factors that influence symptom management and use this knowledge to implement personalized interventions Design strategies that help patients manage symptoms over the course of a disease Support individuals and caregivers in managing chronic illness in cost- effective ways

Improve palliative and end-of-life care

Enhance the scientific knowledge of issues and choices underlying end-of life and palliative care Develop and test interventions that provide palliative care across the lifespan Develop strategies to minimize the burden placed on caregivers Determine the impact of provider training on outcomes Create communication strategies to promote end-of-life care

Enhance innovation in science and practice

Develop technologies and informatics-based solutions for health problems Develop and apply technology for disseminating and analyzing health information Examine the use of healthcare technology to support self-management of health, decision making, and access to care Study the use of genetic and genomic technology to understand the biological basis of the symptoms of chronic disease

Develop the next generation of nurse scientists

Support the development of nurse scientists at all stages of their careers Facilitate the transition of nurses from student to scientist Recruit young nurse investigators, particularly those from diverse backgrounds Mobilize technology to form global partnerships to support research in areas central to NINR’s mission

Data from National Institute of Nursing Research. (2011). Bringing science to life: NINR strategic plan. NIH Publication #11-7783, Bethesda, MD: Author.

GRAY MATTER Nurses may play a variety of roles in research, including the following:

Informed consumer of research Participant in research-related activity, such as journal clubs Contributor to a systematic review Data collector for a research project Principal investigator for a research study

The 1990s and early twenty-first century saw a shift in emphasis from research as an academic activity to research that serves as a basis for nursing practice. The impetus for this shift was partially due to external influences that created demands for accountability, effectiveness, and efficiency. Internal influences in the profession also played a key role in this shift, as nursing professionals strive to create a norm of professional practice that is firmly grounded in best demonstrated practice.

Contemporary Nursing Research Roles The nurse may be an effective team member on any number of research projects and may take on responsibilities ranging from data collection to research design. The broad number of potential roles in the research setting provides nurses with the chance to participate at their individual comfort level while learning increasingly complex research skills. The professional clinician has both opportunities and responsibilities to use research in a variety of ways to improve practice. Table 1.2 contains the statement from the American Association of Colleges of Nursing (2006) that describes the expected roles of nurses in research processes.

Most nurses are first exposed to clinical research as informed consumers. The informed consumer of research is able to find appropriate research studies, read them critically, evaluate their findings for validity, and use the findings in practice. Nurses may also participate in other types of research-related activities, including journal clubs or groups whose members meet periodically to critique published studies or care standards. Journal clubs are relatively easy to implement and have been demonstrated to be one of the most effective means for sustaining staff nurse enthusiasm for and participation in EBP implementation (Gardner et al., 2016). Attending research presentations and discussing posters at conferences also expose nurses to a variety of research studies.

Journal club: A formally organized group that meets periodically to share and critique contemporary research in nursing, with a goal of both learning about the research process and finding evidence for practice.

Table 1.2 Research Expectations for Nurses

Educational Level

Research Role

Baccalaureate degree

Have a basic understanding of the processes of research. Apply research findings from nursing and other disciplines to practice. Understand the basic elements of evidence-based practice. Work with others to identify research problems. Collaborate on research teams.

Master’s degree

Evaluate research findings to develop and implement EBP guidelines. Form and lead teams focused on evidence-based practice. Identify practices and systems that require study. Collaborate with nurse scientists to initiate research.

Practice-based doctorates

Translate scientific knowledge into complex clinical interventions tailored to meet individual, family, and community health and illness needs. Use advanced leadership knowledge and skills to translate research into practice. Collaborate with scientists on new health research opportunities.

Research- focused doctorates

Pursue intellectual inquiry and conduct independent research for the purpose of extending knowledge. Plan and carry out an independent program of research. Seek support for initial phases of a research program. Involve others in research projects and programs.

Postdoctoral programs

Devote oneself fully to establishing a research program and developing as a nurse scientist.

Modified with permission from American Association of Colleges of Nursing. (2006). AACN position statement on nursing research. Washington, CD: Author.

As the nurse becomes more proficient in the research process, involvement in a systematic review is a logical next step. Conducting a systematic review that results in an evidence-based practice guideline requires the ability to develop research questions methodically, write inclusion criteria, conduct in- depth literature searches, and review the results of many studies critically. Participation in such activities also facilitates changes in clinical practice on a larger scale and requires the nurse to use leadership and communication skills.

Systematic review: A highly structured and controlled search of the available literature that minimizes the potential for bias and produces a practice recommendation as an outcome.

Evidence-based practice guideline: A guide for nursing practice that is the outcome of an unbiased, exhaustive review of the research

literature, combined with clinical expert opinion and evaluation of patient preferences. It is generally developed by a team of experts.

Involvement in actual research studies does not require complete control or in- depth design abilities. Indeed, assisting with data collection can take the form of helping measure outcomes on subjects or personally participating as a subject. Clinicians are frequently recruited to participate in studies or collect data directly from patients or their records. Collecting data for the studies of other researchers can give the nurse valuable insight into the methods used to maximize reliability and validity—experience that will help the nurse later if he or she chooses to design an experiment.

Most nurses do not immediately jump into research by undertaking an individual research study, but rather serve on a research team as an initial foray into this area. As part of a team, the nurse can learn the skills needed to conduct research while relying on the time and expertise of a group of individuals, some of whom may be much more experienced researchers. Serving on a team in this way gives the nurse the opportunity to participate in research in a collegial way, collaborating with others to achieve a mutual goal.

A contemporary means for enhancing staff nurse participation in research is through adoption of the clinical scholar or nurse scholar role. Nurse scholar programs typically seek out clinical nurses for specialized training in research and EBP. These nurses are then provided with releases from their usual workloads so that they can identify evidence-based problems, design studies to answer clinical questions, and carry out EBP projects. One study found that a nurse scholar program increased the number of EBP projects by as much as 10 times, led to significant practice improvements, and enhanced the confidence of the clinical nurses who participated in EBP development (Crabtree, Brennan, Davis, & Coyle, 2016).

The most advanced nurses may serve as principal investigators, or producers of research, who design and conduct their own research projects. Because individuals are rarely able to accomplish research projects on their own, it is more likely that the nurse will lead a research team. This role requires not only research and analytic skills, but also skills in leading groups, managing projects, and soliciting organizational commitment.

Principal investigator: The individual who is primarily responsible for a research study. The principal investigator is responsible for all elements of the study and is the first author listed on publications or presentations.

Research Versus Problem Solving

Research is distinct from other problem-solving processes. Many processes involve inquiry. In an organizational setting, quality improvement, performance improvement, and outcomes measurement all involve systematic processes and an emphasis on data as a basis for decisions. For an individual nurse, the nursing process requires that the nurse gather evidence before planning an intervention and subsequently guides the nurse to evaluate the effectiveness of care objectively. Although both organizational and individual problem-solving processes may be systematic and objective, these are not synonymous with research in intent, risks, or outcome (Lee, Johnson, Newhouse, & Warren, 2013). The correct identification of the type of inquiry that is being conducted and reported will help the nurse link the outcome to the appropriate level of practice recommendation (Baker et al., 2014).

Quality improvement: The systematic, databased monitoring and evaluation of organizational processes with the end goal of continuous improvement. The goal of data collection is internal application rather than external generalization.

Outcomes measurement: Measurement of the end results of nursing care or other interventions; stated in terms of effects on patients’ physiological condition, satisfaction, or psychosocial health.

Nursing process: A systematic process used by nurses to identify and address patient problems; includes the stages of assessment, planning, intervention, and evaluation.

The intent of quality improvement is to improve processes for the benefit of patients or customers within an organizational context. Studies in this area are often undertaken to determine if appropriate and existing standards of care are practiced in a specific clinical setting (Baker et al., 2014). Quality improvement is basically a management tool that is used to ensure continuous improvement and a focus on quality. Research, in contrast, has a broader intent. Its goal is to benefit the profession of nursing and to contribute to the knowledge base for practice. Research benefits more people because it is broadly applied; quality improvement is beneficial simply because of its specificity to a single organization.

The risk for a subject who participates in a quality improvement study is not much more than the risk associated with receiving clinical care. Such studies are frequently descriptive or measure relationships that are evidenced by existing data. Often, patients who are the subjects of study for a quality

improvement project are unaware they are even part of a study. In contrast, in a research project, subjects are clearly informed at the beginning of the project of the risks and benefits associated with participating in the study, and they are allowed to withdraw their information at any time. Upfront and informed consent is central to the research process.

Finally, the outcomes of a quality improvement study are intended to benefit a specific clinical group and so are reviewed by formal committees and communicated internally to organizational audiences. In contrast, research findings are subjected to rigorous peer review by neutral, external reviewers, and the results are expected to stand up to attempts to replicate them. When quality improvement projects are planned with an expectation of publication, the distinction becomes less clear. Is the goal of publication to share a perspective on a process or to generalize the results to a broader group of patients? If the latter goal is targeted, then quality improvement projects should be subjected to the same rigorous review and control as a research project.

The intent when an individual nurse applies the nursing process for problem solving is even more specific. The nursing process requires an individual nurse to gather data about a patient, draw conclusions about patient needs, and implement measures to address those needs. Data collected from the patient are used to evaluate the effectiveness of care and make modifications to the plan. These steps mirror the research process but take place at an individual level. Research is useful within the nursing process as a source of knowledge about assessment procedures, problem identification, and effective therapeutics, but simply using the nursing process does not constitute research.

GRAY MATTER The research process is distinct from other problem-solving processes in the following respects:

Research contributes to the profession of nursing as a whole, not just a single organization or patient. Research involves an explicit process of informed consent for subjects. Research is subjected to external peer review and replication.

Research as Evidence in Nursing Practice It would seem a foregone conclusion that effective nursing practice is based on the best possible, most rigorously tested evidence. Yet it is only in the past two decades that an emphasis on evidence as a basis for practice has reached the forefront of professional nursing. Although it may be surprising that the scientific basis for nursing practice has been so slow to be accepted,

many reasons exist to explain why evidence-based nursing practice is a relatively recent effort. The past decade has seen unprecedented advances in information technology, making research and other types of evidence widely available to healthcare practitioners. Whereas a nurse practicing in the 1980s might have read one or two professional journals per month and attended perhaps one clinical conference in a year, contemporary nursing professionals have access to an almost unlimited array of professional journal articles and other sources of research evidence via the Internet. Technology supports the communication of best practices and affords consumers open access to healthcare information as well. As a result, EBP is quickly becoming the norm for effective nursing practice.

Evidence-Based Practice What Evidence-Based Practice IS Evidence-based practice is the use of the best scientific evidence, integrated with clinical experience and incorporating patient values and preferences in the practice of professional nursing care. All three elements in this definition are important. As illustrated in FIGURE 1.1, the triad of rigorous evidence, clinical experience, and patient preferences must be balanced to achieve clinical practices that are both scientifically sound and acceptable to the individuals applying and benefiting from them.

Evidence-based practice: The use of the best scientific evidence, integrated with clinical experience and incorporating patient values and preferences in the practice of professional nursing care.

FIGURE 1.1 The Triad of Evidence-Based Practice

Although healthcare practitioners have long used research as a basis for practice, a systematic approach to the translation of research into practice has emerged only in relatively recent times. The impetus for EBP was a 1990

comment by a Canadian physician on the need to “bring critical appraisal to the bedside.” The first documented use of the term evidence-based practice appeared more than two decades ago, when a clinical epidemiology text (Sackett, Haynes, Guyatt, & Tugwell, 1991) used the term to describe the way students in medical school were taught to develop an attitude of “enlightened skepticism” toward the routine application of diagnostic technologies and clinical interventions in their daily practice. The authors described how effective practitioners rigorously review published studies to inform clinical decisions. The goal, as stated in this publication, was to achieve an awareness of the evidence on which professional practice is based and a critical assessment of the soundness of that evidence.

The term entered the U.S. literature in 1993 when an article in the Journal of the American Medical Association described the need for an established scientific basis for healthcare decisions (Oxman, Sackett, & Guyatt, 1993). The authors of the article noted that the goal of EBP is to help practitioners translate the results of research into clinical practice, and they recognized that the scientific practice of health care required sifting through and appraising evidence to make appropriate decisions.

EBP has rapidly evolved into an international standard for all healthcare practitioners. Using the best scientific evidence as a basis for practice makes intuitive sense and places nursing in the company of the other science-based health professions in using evidence as a foundation for clinical decision making.

What Evidence-Based Practice Is NOT A wide range of activities contributes to EBP. Many of these activities—such as reviewing research, consulting expert colleagues, and considering patient preferences—are common in nursing practice. Even so, many such activities are not considered EBP, but rather other forms of decision making used to solve problems.

Evidence-Based Practice Is Not Clinical Problem Solving Although EBP serves as a mechanism for solving clinical problems and making decisions about interventions, it remains distinct from traditional problem-solving approaches in health care. Conventional decision making about clinical practices relied on expert opinion—sometimes achieved by consensus, but rarely through experimentation— combined with standard practice. EBP, by comparison, is a systematic process of critically reviewing the best available research evidence and then incorporating clinical experience and patient preferences into the mix.

Evidence-Based Practice Is Not Solely Randomized Controlled Trials

EBP does not mean choosing only those interventions supported by randomized controlled trials—although these studies are clearly important in providing guidance for effective practices. A somewhat tongue-in-cheek article by Smith and Pell (2006) suggested that we did not need a randomized trial to inform practitioners of the importance of a parachute as a measure of preventing death when jumping from an airplane (and, in fact, noted the difficulty in recruiting a control group for such a trial!). EBP does not rely solely on one type of evidence, but rather is founded on a hierarchy of evidence, with individual studies rated on a scale from “strongest” to “weakest” based on the type of design and quality of execution. Evidence can come from many different types of studies in addition to randomized trials.

Randomized controlled trial: An experiment in which subjects are randomly assigned to groups, one of which receives an experimental treatment while another serves as a control group. The experiment has high internal validity, so the researcher can draw conclusions regarding the effects of treatments.

Evidence-Based Practice Is Not “Cookbook Medicine” The existence of guidelines based on the best available evidence does not mean the practitioner has an edict to practice in a single way. In fact, evidence alone is never sufficient to make a specific clinical decision about a specific patient. The nurse needs evidence plus good judgment, clinical skill, and knowledge of the patient’s unique needs to apply evidence to a specific patient care situation. The definition of EBP, in fact, holds evidence as only one element of the triad of decision making; that is, clinical judgment and patient values must also be considered when applying the evidence to a particular situation.

Evidence Is Not the Same as Theory Theoretical effects must be tested and retested before therapies can be determined to be effective. As late as the early twentieth century, physicians still believed that blood-letting was an effective treatment for a host of disorders. This belief was based on the empirical observation that a patient’s pulse rate slowed when he or she was bled and the theory that a slower pulse reduced irritation and inflammation. Although the empirical observations were accurate—the patient’s pulse would certainly slow when bloodletting was performed, but due to impending hypovolemic shock—the theoretical relationship to a therapeutic response was ill founded. Many contemporary healthcare interventions are, unfortunately, based on similar theoretical relationships that have been untested for years. Recent research has refuted many of these theoretical assumptions, including the protective value of hormone-replacement therapy, the use of rubbing alcohol to prevent infection in a neonate’s umbilical cord, and the use of heat to treat acute inflammation, among many others.

Evidence-Based Nursing Is Not Evidence-Based Medicine The nature and processes of research are likely to be unique for any given profession. In the health realm, medicine and nursing have different philosophical roots and approaches to patient care. Medicine relies on an extensive scientific knowledge base that is primarily concerned with the cause of disease and effects of treatment. The evidence for medical care, by necessity, focuses on scientific studies that quantify these effects. Nevertheless, medical evidence has been criticized for its sometimes artificial nature. It is a research paradox that the more an experiment is controlled, the less applicability the results will have in the real world. Randomized controlled trials, then, may provide the most rigorous scientific evidence, but that evidence may not apply very well to individual patients with a broad range of physical, psychological, and behavioral conditions.

Nursing, in contrast, requires a holistic approach to the care of individuals with physical, psychosocial, and/or spiritual needs. This care is founded on the nurse–patient relationship and the nurse’s appreciation for the patient’s unique needs. The evidence for nursing care, then, requires a broad range of methodologies as a basis for care. This is not to imply that these sources of evidence are not subjected to healthy skepticism and systematic inquiry, but rather that a broader range of evidence is considered as a basis for practice.

The Importance of Evidence-Based Practice in Nursing EBP is important to the nurse for many reasons. At the top of this list is the contribution of evidence to the effective care of patients. Studies have supported the contention that patient outcomes are substantially improved when health care is based on evidence from well-designed studies versus tradition or clinical expertise alone. Evidence has been shown to be effective in supporting practices that achieve optimal outcomes in a range of behavioral, physiological, and psychosocial outcomes. In one recent meta-analysis, Leufer and Cleary-Holdforth (2009) aggregated outcomes studies related to EBP changes. A wide range of effects was found in multiple specialties including orthopedic, cardiovascular, respiratory, and obstetric outcomes. EBPs in obstetrics and neonatal care reduced morbidity and mortality, sometimes dramatically. The use of corticosteroids in premature labor, for example, reduced the risk of premature infant death by 20%. In another study, Deighton et al. (2016) demonstrated an association between EBPs and mental health outcomes, particularly for interventions related to the treatment of emotional disorders. The linkage between EBPs and outcomes is an important one, and determining the scientific support for a practice prior to its implementation makes intuitive sense.

Today’s healthcare providers operate in an era of accountability, in which quality issues, patient safety, and cost concerns are primary drivers of patient care processes (Markon, Crowe, & Lemyre, 2013). Practices that are

unnecessary are eliminated; ineffective practices are replaced with practices that result in desired outcomes.

Existing practices may even be unintentionally harming patients (as was found in the hormone-replacement studies), so it is ethically unjustified to continue using untested interventions. Evidence can help healthcare professionals avoid errors in decision making relative to patient care. Using research decreases the need for trial and error, which is time consuming and may prove counterproductive. In any case, time is not wasted on practices that may be ineffective or unnecessarily time intensive.

Today’s consumers are well informed about their options for personal health care and often resist the traditional, paternalistic approach to health interventions. The public expects that care will be based on scientific evidence and believes that care processes should routinely lead to high-quality outcomes that are physically and mentally desirable. Healthcare professionals, in turn, must be able to respond to their patients’ questions about the scientific merit of interventions and about the relative benefit of treatment options.

GRAY MATTER EBP is important in nursing practice because research has shown that

Patient outcomes are better when evidence is used as a basis for practice. Nursing care is more efficient when ineffective processes are replaced. Errors in decision making become less frequent with EBP. Consumers want evidence-based information to make decisions.

Evidence can take a variety of forms—journal articles, policies, guidelines, professional consensus statements, and standards of practice as well as formalized research. Although EBP implies scientific evidence, the words relevant and rigorous might be better adjectives to describe the kind of evidence needed by healthcare professionals. Critical skills include the ability to judge both the type of evidence that is needed and the value of that evidence.

Healthcare practitioners do not practice in professional isolation, but rather explore what works and does not work using empirical methods. An increased emphasis on EBP can be viewed as a response to these broader forces influencing the context of healthcare delivery and as a logical progression toward the utilization of research as a basis for patient care decisions.

How Can Evidence Be Used in Health Care?

At its best, evidence provides the basis for effective, efficient patient care practices. At a minimum, an evidence-based approach can enhance practice by encouraging reflection on what we know about almost every aspect of daily patient care. The EBP process need not be onerous, because it basically entails just six elements: (1) Ask a relevant clinical question, (2) search for the best evidence in the literature, (3) critically appraise the evidence, (4) integrate the evidence with clinical experience and client preferences, (5) evaluate the outcome of the practice change, and (6) disseminate the outcome (Facchiano & Snyder, 2012). The original question can come from a variety of sources in a healthcare setting; likewise, evidence can improve outcomes for a wide range of organizational processes.

Evidence as a Basis for Healthcare Processes Evidence can be incorporated into virtually every phase of the healthcare process. For example, evidence exists for best practices in the following areas:

Assessment of patient conditions Diagnosis of patient problems Planning of patient care Interventions to improve the patient’s function or condition, or to prevent complications Evaluation of patient responses to intervention

Evidence as a Basis for Policies and Procedures Although healthcare professionals from different educational programs, backgrounds, and experience may have different ways of delivering patient care, few can argue with the need for best practices. EBP provides the foundation for policies and procedures that are tested and found effective, as opposed to “the way we’ve always done it.”

Evidence as a Basis for Patient Care Management Tools The evidence that is revealed through systematic review of research and other sources provides an excellent basis for patient care management tools such as care maps, critical paths, protocols, and standard order sets. A major benefit of using patient care management tools is reduction of variability in practices, and evidence serves as a rational basis for standardized practices.

Evidence as a Basis for Care of the Individual The complexity of patients who need care in the healthcare system can make the clinician wonder if evidence can ever be applied to an individual patient. It is easy to consider the question, “Is my patient so different from those in the research that results will not help me make a treatment decision?” This question, more than any other, may stand in the way of applying evidence to individual patient care situations. In fact, one study found that the more familiar

a patient was to a practitioner, the less likely the clinician was to use evidence as a basis for that person’s care (Summerskill & Pope, 2002).

As practitioners, we must ask whether these assumptions about the uniqueness of patients are in their best interests when it comes to clinical care. Uncertainty is inherent in the healthcare process; evidence helps to quantify that uncertainty. Concern for the uniqueness of the individual patient is not a reason to ignore the evidence, but rather an impetus to learn to apply the evidence both critically and appropriately. Evidence is not intended to be rigid, but rather—as our definition makes explicit—to be integrated with clinical experience and a patient’s unique values to arrive at optimal outcomes.

Evidence in clinical practice is not solely limited to patient care, however. Healthcare professionals might be interested in evidence as it relates to team functioning, the best way to communicate change, organizational models for research utilization, or even the effects of insurance on healthcare usage. Evidence in health care abounds on a variety of topics, and research utilization can improve patient care in a multitude of ways.

GRAY MATTER Evidence can be used as a basis for the following aspects of nursing practice:

Nursing care processes such as assessment, diagnosis, treatment, and evaluation Policies and procedures that guide nursing practice within an organization Patient care management tools such as care maps, standard order sets, and critical paths Care decisions regarding individual patient needs

Strategies for Implementing Evidence-Based Practice Considering the benefits of basing clinical nursing practice on evidence, it would make sense for evidence-based nursing practice to be the norm. Unfortunately, this is not the case. In an integrative review conducted by Saunders and Julkunen (2016), the vast majority of nurses were found to believe in the value of EBP in improving care quality and patient outcomes. Even so, most of the nurses considered their own knowledge and skills insufficient for employing EBP, and did not believe they were using evidence as a basis for their own practice.

Many reasons can be cited to explain why EBPs are the exception rather than the rule, including limitations created by EBP systems themselves. Some barriers are related to human factors, whereas others are related to the

organizations within which nursing care is delivered. Table 1.3 lists some of the common barriers to using evidence as a basis for practice.

Organizations do not commonly have systems in place to support clinicians in the development of EBP tools. Although more resources have become available to practitioners who want to participate in the development of practice guidelines, few operational models exist to guide healthcare organizations that want to implement pervasive EBP (Houser & Oman, 2011). Even when nurses are motivated and competent in the creation and use of EBPs, barriers in the organizational culture may hinder their ability to increase the use of EBP in the workplace (Williams, Perillo, & Brown, 2015). The impact of culture is a strong one; in Williams et al.’s study, nurses reported that their colleagues’ lack of support for changing practice was one of the most formidable barriers to EBP. A collaborative workplace where questioning of current practices is encouraged is needed for wide-scale adoption of EBPs, yet it remains the exception rather than the rule.

Table 1.3 Barriers to Using Evidence in Clinical Practice

Limitations in evidence- based practice systems

Overwhelming amount of information in the literature Sometimes contradictory findings in the research

Human factors that create barriers

Lack of knowledge about evidence-based practice Lack of skill in finding and/or appraising research studies Negative attitudes about research and evidence-based care Perception that research is for medicine, not nursing Patient expectations (e.g., demanding antibiotics)

Organizational factors that create barriers

Hierarchical structures that do not encourage autonomous decision making Lack of authority for clinicians to make changes in practice Colleagues’ lack of support for practice change Demanding workloads with no time for research activities Conflict in priorities between unit work and research Lack of administrative support or incentives

The complexities of changing practice based on evidence are daunting indeed. Majid and colleagues (2011) studied the barriers to and facilitators of EBP as perceived by more than 2000 nurses in organizational settings. Although the nurses in this study generally held positive views about the value of EBP, they also described several barriers to its implementation:

Not enough time to keep up with evidence review given their workload Lack of adequate training and educational support for appraisal of evidence Inability to understand statistical and research terminology Inadequate organizational and leadership support Lack of access to databases and search strategies

An additional barrier identified in the study by Williams et al. (2015) was the lack of authority to change practices in a hierarchical organization. These researchers found that top-down organizations and those in which nurses had little autonomy were the least likely to have a widespread EBP culture. To implement EBP effectively, nurses must believe that their inputs and ideas are valued, and must perceive that they have a level of power appropriate to enact changes within their practices.

An updated review of the literature from 2010 to 2015 conducted by Mallion and Brooke (2016) yielded more heartening findings. These researchers discovered that the traditional barriers of lack of time, knowledge, and skill continue to affect the wholesale adoption of EBPs, but that nurses’ attitudes toward EBP had changed over time. While still acknowledging the difficulty inherent in continuously adopting EBP, the nurses in these studies included in Mallion and Brooke’s literature review valued evidence and had positive impressions of their ability to improve practice.

Strategies for Overcoming Barriers Although little can be done to reduce the complexity of contemporary clinical care, some strategies can be undertaken to improve the rate at which healthcare professionals utilize research as a basis for their practice.

Begin the process by specifically identifying the facilitators of and barriers to evidence-based practices. Use of a self-assessment tool such as that tested by Gale and Schaffer (2009) can help identify organizational strengths and limitations in preparation for an EBP effort.

Education and training can improve knowledge and strengthen practitioners’ beliefs about the benefits of EBP. Clinicians may fear they will appear to lack competence if they engage in EBP, and greater knowledge will give them confidence in determining an evidence base for their practice.

One of the most helpful—and difficult—strategies is to create an environment that encourages an inquisitive approach about clinical care. The first step in identifying opportunities for best practices is questioning current practice. This can be accomplished by creating a culture in which EBPs is valued, supported, and expected, and in which nurses have the authority and autonomy to change practices within their scope of care.

Florczak (2016) has even more basic recommendations for improving research uptake: Nurse researchers, first and foremost, need to conduct studies that are of high quality, especially in terms of sampling methods and controls. Nurses will not be confident about incorporating evidence into practice unless that evidence is strong and convincing. Studies chosen by nurse researchers should focus on outcomes relevant to practice, in which considerations related to patient response, nurse burden, and costs are

addressed in addition to effectiveness. Researchers are well advised to collaborate with practitioners and patients in the design of studies and recommendations intended for application to practice.

Despite the barriers inherent in implementing EBP in clinical practice, it is imperative that nurses create structures and processes that reduce these obstacles. Regardless of the system within which the clinician practices, a systematic approach can be employed to find and document the best possible evidence for practice. This process involves defining a clinical question, identifying and appraising the best possible evidence, and drawing conclusions about best practice.

Reading Research for Evidence-Based Practice Reading research as evidence requires that the professional nurse have a basic understanding of research processes and can apply that understanding to the critical appraisal of individual studies. This systematic process of assessing the reliability, validity, and trustworthiness of studies is explored in detail throughout this text. The appraisal process begins by determining whether the journal, authors, and publication process are credible.

Consider the following key issues when assessing credibility:

Does the author have the appropriate clinical and educational credentials for the research study? If not, have team members been recruited who have the requisite knowledge and skill? Teams strengthen the results of a research project by providing a diversity of perspectives and enlarging the expertise that is accessible to the team members. Is there evidence of a conflict of interest that might introduce bias into the study? For example, does the financial sponsor of the study have something to gain from positive or negative results? Sponsors may unintentionally impose their own expectations on a study and a researcher that may introduce bias into the study. Do the authors have an association with any of the entities in the study? If the authors are employed by an agency being tested in the study, then researcher bias might potentially influence the interpretation of data or the selective reporting of findings. Is the journal unbiased? In other words, does the publication have anything to gain by publishing positive or negative results? The publication should have an external editorial board and a cadre of reviewers who are not associated financially with the publication. The names and credentials of the editorial board should be accessible in the publication. Has the research study undergone blinded peer review? Blinded peer review enables a critical appraisal of the research study by a neutral party who is not influenced by the stature (or lack of it) of the authors. Has the study been published within a reasonable time frame? Health care is characterized by a rapidly changing clinical environment, and studies whose publication is delayed may be outdated before they reach print.

Many journals note the date on which a manuscript was received and the length of time until it was reviewed and accepted. This type of notice enables the reader to determine if the information in the study is contemporary or subject to historical effects.

It is sometimes difficult to determine whether a journal is peer reviewed. This policy may be explicitly stated in the front of the journal, but the absence of such a description does not mean the journal is not a scholarly one. The reader may have to scrutinize the front matter of a journal (the masthead and publication information) or a journal webpage to determine the nature of the publication.

The front matter should also include the names of the external editorial board. The existence of an external editorial board means there is objective oversight of the content and quality of material published in the journal. The names of actual reviewers are rarely published, however; the peer review process is more likely a blinded one, meaning that article authors do not know the identity of the manuscript reviewer, and the reviewer does not know the identity of the authors.

If it is not clear whether the journal is peer reviewed, or if an article has been retrieved electronically and the journal’s front matter is not available, some hints may indicate whether a journal is a scholarly one. Characteristically, peer-reviewed journal issues are identified by volume and number, and the pages are numbered sequentially through the entire year instead of starting over with each issue. An article published in October, therefore, would likely have page numbers in the hundreds. The first page may also specify the date on which a manuscript was received, reviewed, and subsequently published. This information would confirm that a journal article has been peer reviewed.

The first page of the article should describe the author’s credentials and place of employment, along with contact information. Any potential conflicts of interest should be identified here as well. Funding sources for research studies might appear in the credentials section or at the end of the article. Ideally, the journal will also identify any potential conflicts of interest—such as companies owned by the journal’s parent company—that might introduce bias into the publication’s selection process.

Reading research, much like any nursing skill, becomes easier with practice. As a practicing nurse reads, studies, and engages in research projects, this process becomes more efficient and informative. The process of evaluating research, which may initially require a great deal of focus and effort, eventually becomes second nature. As the appraisal of research becomes part of the nurse’s routine, the ability to select studies for application to practice allows the nurse to ensure that his or her practice is based on sound evidence.

Using Research in Evidence-Based Practice Research is a key EBP. Scientific, rigorous, peer-reviewed studies are the foundation of evidence for professional nursing practice. Selecting, reviewing, and incorporating research findings into practice lie at the heart of professional nursing care delivery; however, EBP does not eliminate the need for professional clinical judgment. The application of a specific EBP guideline to a specific patient situation is based on the nurse’s assessment of the situation and an appraisal of the interventions that are most likely to be successful. The clinician remains responsible for combining evidence with clinical expertise and patient values in managing individual patients and achieving optimal outcomes.

Where to Begin? The process of applying research to EBP begins by identifying a problem that will be best addressed by a review of the evidence. The choice of a subject to study may be driven by a variety of factors. Newell-Stokes (2004) classifies three general categories that may uncover the need for EBP.

The first category includes problem-focused factors. These factors are generally clinical problems that are identified through quality improvement processes, benchmarking studies, regulatory agency feedback, practicing clinicians, or administrative data. For example, a hospital may identify a problem with skin breakdown through nurse observation, quality data indicating an increase in pressure ulcer rates, analysis indicating pressure ulcer rates that are higher than those in comparable hospital units, or data that demonstrate higher costs for patients with skin breakdown.

The second category includes factors related to nursing knowledge. A knowledge deficit may be evident, or new knowledge may emerge through research studies. In addition, a new professional association or new national guideline presents opportunities for incorporating evidence-based changes into practice. A practice change often has a better chance of implementation if users perceive the existence of a solid base of evidence for that practice change. For example, a nurse who attends a national conference may find that hydrotherapy is an evidence-based treatment for pressure ulcers and use the information to motivate a change in nursing practice.

The third category includes factors such as new equipment, technology, or products that become available to the nurse. All of these new developments present opportunities to use evidence in practice to improve outcomes.

Once the need is identified for a change in practice, the way the research is gathered and used may take a variety of forms.

CHECKLIST FOR EVALUATING THE CREDIBILITY OF A RESEARCH ARTICLE

❏ The authors have the appropriate clinical and educational credentials for this research study.

❏ There is no evidence of any conflict of interest for the authors that might introduce bias into the way the study is designed or the way the results are viewed.

❏ There is evidence that this journal is peer reviewed (at least one of these):

Pages are sequentially numbered for the entire year.

Issues are identified by volume and number.

The journal has an external editorial board.

The article indicates a review date.

❏ The publication has no financial connection to positive or negative results from the study.

❏ The study has been published in a reasonable time frame (i.e., a reasonable interval from the date of study to the date of publication).

Processes for linking Evidence to Practice Evidence can be incorporated into practice through several processes. For example, an individual nurse may appraise research studies and share findings with colleagues. Also, a specific question may be answered by reviewing the literature or attending research presentations at conferences.

Although reviewing research studies is a good beginning for establishing evidence for nursing practice, it is possible to introduce bias into the selection of the articles to review. Nurses may consciously or unconsciously select only those articles that support their point of view while ignoring studies that challenge their beliefs. Engaging in a systematic review process will control the potential for such bias to occur. A systematic review process is a structured approach to a comprehensive research review. It begins by establishing objective criteria for finding and selecting research articles, combined with documentation of the rationale for eliminating any study from the review.

Research studies that are selected for inclusion in the review should be subjected to careful and thorough appraisal of study quality and validity. They are graded based on the strength of evidence they provide as well as their design and quality criteria. Several different rating scales may be used to evaluate a research study’s strength as evidence, but it is important to recognize that one rating system is not necessarily better than another. Individual values, the nature of the practice question, and the kind of knowledge needed drive the choice of a rating system. Most grading systems

include between four and six levels. Table 1.4 depicts a rating system for levels of evidence that is a composite of the work of Armola et al. (2009), Ahrens (2005), and Rice (2008).

Table 1.4 Rating Systems for Grading levels of Evidence

Level of Rating

Type of Study

Level I Multiple randomized controlled trials (RCTs) reported as meta-analysis, systematic review, or meta-synthesis, with results that consistently support a specific intervention or treatment Randomized trials with large sample sizes and large effect sizes

Level II Evidence from well-designed controlled studies, either randomized or nonrandomized, with results that consistently support a specific intervention or treatment

Level III

Evidence from studies of intact groups Ex-post-facto and causal-comparative studies Case-control or cohort studies Evidence obtained from time series with and without an intervention Single experimental or quasi-experimental studies with dramatic effect sizes

Level IV

Evidence from integrative reviews Systematic reviews of qualitative or descriptive studies Theory-based evidence and expert opinion Peer-reviewed professional organization standards with supporting clinical studies

Using this scale, for example, a randomized trial of the use of aromatherapy in a post-anesthesia care unit to reduce nausea would be classified as the strongest level of evidence if the findings came from a large study with definitive results or if the results were successfully replicated several times at several sites. The same study conducted in a single setting with a small sample of convenience would provide evidence that was less authoritative. Weaker still would be evidence that was generated through observation or expert opinions.

These strength-of-evidence rating scales apply primarily to the evaluation of treatments, interventions, or the effectiveness of therapies. Recall the definition of EBP: practice based on the best demonstrated evidence combined with clinical experience and patient preferences. The hierarchy of evidence may look quite different depending on the nature of the practice under study.

Review and rating of the evidence should result in recommendations for practice, with the strength of these recommendations being commensurate with the level of evidence and the quality of the study. The link between the strength of the evidence and the strength of the resulting recommendation is

the way in which varying levels of evidence are incorporated into a single practice guideline. Table 1.5 depicts the way that the American Academy of Pediatrics (2004) recommends that evidence be linked to a subsequent system of recommendations. Based on the strength of the evidence and the preponderance of benefit or harm, recommendations are generated that are classified as strongly recommended, optional, or recommended. Some evidence results in no recommendation because a conclusion cannot be definitively drawn. Some evidence that shows harm to the patient may result in “not recommended” status.

The systematic review process is complex and time consuming, and should be undertaken only when no other EBP guidelines exist. The effort is warranted, though, when no clear guidance exists for specific practices, or when the development of a guideline is likely to be affected by practitioner bias.

Table 1.5 The link Between Evidence and Recommendations for Practice

Type of Evidence Clear Evidence of Benefit or Harm

Benefit and Harm Are Balanced

Well-designed, randomized controlled trials (RCTs) or reports of multiple RCTs

Strong recommendation for or against the intervention.

Action is optional.

RCTs with limitations of quasi- experimental studies

Recommendation for or against the intervention.

Action is optional.

Observational and descriptive studies, case controls, and cohort designs

Recommendation for or against the intervention.

Action is optional.

Expert opinion, case studies Action is optional. No recommendation for or against the intervention.

Reproduced with permission from American Academy of Pediatrics. (2004). American Academy of Pediatrics policy statement: Classifying recommendations for clinical practice guidelines. Pediatrics, 114, 874–877. Copyright © 2004 by the AAP.

Creating Evidence for Practice Nurses commonly serve as the primary investigators in studies that focus on the needs of patients and the effectiveness of nursing interventions. When a nurse conceives of, designs, and implements a research project, he or she is designated as a primary investigator. The primary investigator is responsible for all aspects of a research study’s conduct and outcome, even if a team is involved. The primary investigator also has the right to be the first author noted on a research publication.

Designing a research study is an advanced and complex skill that requires experience in the clinical processes under study as well as an understanding

of the complexity of research design and analysis. That is not to say that the professional nurse cannot gain the skill and experience needed to be a primary investigator—only that becoming a nurse researcher is an evolutionary process that occurs over time. It is the rare nurse who is able to design and conduct a brilliant study on the first attempt. More commonly, a nurse learns the process by becoming involved in the research of others in some way—either in data collection, through team participation, or even as a subject. Only gradually does he or she gain the ability to conceive of and lead a research project.

Creating nursing research is a systematic, rigorous process. The remainder of this text will guide the nurse as he or she gains the foundation needed to read, use, and create evidence.

Future Directions for Nursing Research It is clear that nursing research will continue to assume a prominent role in supporting the professional practice of nursing. The future of nursing research is exciting and requires that all nurses accept responsibility for seeking and using evidence as a basis for practice. As part of nursing’s future, research will likely evolve into a routine and integral part of the professional nursing practice environment. This requires the engagement of nurses in disciplined inquiry on some level, whether as informed consumers or as primary investigators and team leaders. Nurses must be involved in the promotion of research in support of nursing practices. As such, they must become adept at planning and implementing change in nursing practices. An open mind and adaptability are key characteristics for ensuring adoption of EBPs.

Collaboration with physicians and members of other disciplines in the design and implementation of patient-centered research will continue to elevate nurses to the level expected of all of the health science professions. Participation on a research team encourages other professions to treat nurses as respected colleagues and valued members of the healthcare team.

The future of nursing requires an emphasis on increasing the contribution of research to the knowledge of nursing based on a strategic research agenda. This includes a broadening of the opportunities for dissemination of nursing research findings through research conferences, clinical groups, electronic formats, and publication.

Summary of Key Concepts The practice of nursing is founded on nursing knowledge, and nursing knowledge is generated and disseminated through reading, using, and creating nursing research. Nursing research is a systematic process of inquiry that uses rigorous, systematic approaches to produce answers to questions and solutions to problems in nursing practice. Research is designed so that it is free of bias

and results are trustworthy. The hallmarks of solid, well-respected research are peer review and replication. Nurses may use research to synthesize the findings of others, explore and describe phenomena, find solutions to problems, or test traditional approaches for efficacy. Research is fundamental to nursing practice because conduct of research is characteristic of a profession and nurses are accountable for the care they deliver. Consumers and external agencies are demanding that healthcare professionals provide evidence for the effectiveness of the interventions they propose and implement. Nursing is a relatively young profession, but its practitioners have a proud history of disciplined inquiry. The NINR gives nursing research national stature and financial support and also establishes a national agenda of priorities for nursing research. Nurses may fulfill a variety of roles in contemporary nursing research practice, ranging from informed consumers to data collectors to primary investigators. As they become more proficient in nursing research, their roles may broaden and involve projects of increasing complexity. Research is not synonymous with problem solving; it is intended to benefit the profession as a whole. A systematic approach and upfront, informed consent of subjects are hallmarks of the research process. The benefit of research to nurses lies in its use as evidence for practice. EBP entails the use of the best scientific evidence integrated with clinical experience and incorporating patient values and preferences in the practice of professional nursing care. Numerous types of research are required to accomplish this goal. EBP is important in nursing because outcomes are improved, care is more efficient and effective, and errors are reduced when practitioners use evidence as a standard of care. Consumers are also asking for evidence to help them make decisions about their treatment options, and nurses are in a unique position to provide them with appropriate evidence. Evidence can be used as a basis for nursing practice in assessing the patient’s condition, diagnosing patient problems, planning patient care, evaluating interventions, and evaluating patient responses. Barriers to using evidence as a basis for nursing practice may be related to the nature of evidence in practice, individual issues, or organizational constraints. Nurses must identify barriers to the use of evidence in practice and implement strategies to overcome them. Translation of research into practice is based on a careful evaluation of the characteristics of a patient population, matched with an assessment of the credibility and external validity of studies relative to patient needs. Future directions in nursing research include focusing on research as an integral part of nursing practice in a collaborative environment. Collaboration with other healthcare team members in research enhances the value of the profession as a whole and garners respect for its practitioners.

External validity: The ability to generalize the findings from a research study to other populations, places, and situations.

For More Depth and Detail For a more in-depth look at the concepts in this chapter, try these references:

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Fitzsimmons, E., & Cooper, J. (2012). Embedding a culture of evidence-based practice. Nursing Management, 19(7), 14–21.

Foster, M., & Shurtz, S. (2013). Making the critical appraisal for summaries of evidence (CASE) for evidence-based medicine: Critical appraisal summaries of evidence. Journal of the Medical Library Association, 101(3), 192–198.

Sandstrom, B., Borglin, B., Nilsson, R., & Willman, A. (2011). Promoting the implementation of evidence-based practice: A literature review focusing on the role of nursing leadership. Worldviews on Evidence-Based Nursing, 4, 212–225.

Sullivan, D. (2013). A science perspective to guide evidence-based practice. International Journal of Childbirth Education, 28(1), 51–56.

Upton, P., Scurlock-Evans, L., Stephens, D., & Upton, D. (2012). The adoption and implementation of evidence-based practice (EBP) among allied health professions. International Journal of Therapy and Rehabilitation, 19(9), 497–505.

CRITICAL APPRAISAL EXERCISE Retrieve the following full-text article from the Cumulative Index to Nursing and Allied Health Literature, or a similar search database:

Ortiz, J., McGilligan, K., & Kelly, P. (2004). Duration of breast milk expression among working mothers enrolled in an employer-sponsored lactation program. Pediatric Nursing, 30(2), 111–118.

Review the article, including information about the authors and sponsors of the study. Consider the following appraisal questions in your critical review of this research article:

1. Do the authors have the appropriate clinical and educational credentials for this research study? What are the strengths and

weaknesses of this research team? 2. Is there evidence of any conflict of interest that might introduce

bias into the way the study is designed or the way the results are viewed? Do the authors have any potential to realize a financial gain from the results of this study?

3. What is the evidence that this journal is peer-reviewed? Find the home page of this journal on the Web. Does the journal have an editorial board?

4. Does the journal have anything to gain by publishing positive or negative results from this study?

5. Is there evidence of bias in the way the study was designed or implemented? If so, how does it affect the nurses’ use of these data in the practice setting?

6. Appraise the level of evidence this research study provides the nurse and the strength of the recommendation for practice provided by the results.

References Ahrens, T. (2005). Evidence-based practice: Priorities and

implementation strategies. AACN Clinical Issues, 16(1), 36– 42.

American Academy of Pediatrics. (2004). Policy statement: Classifying recommendations for clinical practice guidelines. Pediatrics, 114(3), 874–877.

American Association of Colleges of Nursing. (2006). AACN position statement on nursing research. Retrieved from http://www.aacn.nche.edu/publications/position/nursing- research

Armola, R., Bourgault, A., Halm, M., Board, R., Bucher, L., Harrington, L., . . . Medina, J. (2009). AACN’s levels of evidence: What’s new? Critical Care Nurse, 29(4), 70–73.

Baker, K., Clark, P., Henderson, D., Wolf, L., Carman, M., Manton, A., & Zavotsky, K. (2014). Identifying the differences between quality improvement, evidence-based practice, and original research. Journal of Emergency Nursing, 40(2), 195–198.

Crabtree, E., Brennan, E., Davis, A., & Coyle, A. (2016). Improving patient care through nursing engagement in evidence-based practice. Worldviews on Evidence-Based Nursing, 13(2), 172–175.

Deighton, J., Argent, R., Francesco, D., Edbrooke-Childs, J., Jacob, J., Fleming, I., . . . Wolpert, M. (2016). Associations between evidence-based practice and mental health outcomes in child and adolescent mental health services. Clinical Child Psychology and Psychiatry, 21(2), 287–296.

Facchiano, L., & Snyder, C. (2012). Evidence-based practice for the busy nurse practitioner: Part one: Relevance to clinical practice and clinical inquiry process. Journal of the American Academy of Nurse Practitioners, 24, 579–586.

Florczak, K. (2016). Evidence-based practice: What’s new is old. Nursing Science Quarterly, 29(2), 108–112.

Gale, B., & Schaffer, M. (2009). Organizational readiness for evidence-based practice. Journal of Nursing Administration, 39(2), 91–97.

Gardner, K., Kanaskie, M., Knehans, A., Salisbury, S., Doheny, K., & Schirm, V. (2016). Implementing and sustaining evidence-based practice through a nursing journal club. Applied Nursing Research, 31, 139–145.

Houser, J., & Oman, K. (2011). Evidence-based practice: An implementation guide for healthcare organizations. Sudbury, MA: Jones & Bartlett Learning.

Institute of Medicine (IOM). (2011). The future of nursing: Leading change, advancing health. Prepared by Robert Wood Johnson Foundation Committee Initiative on the Future of Nursing. Washington, DC: National Academies Press.

Lee, M., Johnson, K., Newhouse, R., & Warren, J. (2013). Evidence-based practice process quality assessment:

EPQA guidelines. Worldviews on Evidence-Based Nursing, 10(3), 140–149.

Leufer, T., & Cleary-Holdforth, J. (2009). Evidence-based practice: Improving patient outcomes. Nursing Standard, 23(32), 35–39.

Majid, S., Foo, S., Luyt, B., Zhang, X., Theng, Y., Yun-Ke, C., & Mokhtar, I. (2011). Adopting evidence-based practice in clinical decision-making: Nurses’ perceptions, knowledge, and barriers. Journal of the Medical Library Association, 99(3), 229–236.

Mallion, J., & Brooke, J. (2016). Community- and hospital- based nurses’ implementation of evidence-based practice: Are there any differences? British Journal of Community Nursing, 21(3), 148–154.

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National Institute of Nursing Research (NINR). (2013, March). NINR mission and strategic plan. Retrieved from http://www.ninr.nih.gov/aboutninr/ninr-mission-and- strategic-plan#right-content

Newell-Stokes, G. (2004). Applying evidence-based practice: A place to start. Journal of Infusion Nursing, 27(6), 381–385.

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American Medical Association, 270, 2093–2095.

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Smith, G., & Pell, J. (2006). Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomized controlled trials. International Journal of Prosthodontics, 19(2), 126–128.

Summerskill, W., & Pope, C. (2002). An exploratory qualitative study of the barriers to secondary prevention in the management of coronary heart disease. Family Practitioner, 19, 605–610.

Williams, B., Perillo, S., & Brown, T. (2015). What are the factors of organizational culture in health care settings that act as barriers to the implementation of evidence-based practice? A scoping review. Nurse Education Today, 35, e34–e41.

Wilson, M., Sleutel, M., Newcomb, P., Behan, D., Walsh, J., Wells, J., & Baldwin, K. (2015). Empowering nurses with evidence-based practice environments: Surveying Magnet, Pathway to Excellence, and non-Magnet facilities in one healthcare system. Worldviews on Evidence-Based Nursing, 12(1), 12–21.

Chapter 2: The Research Process and Ways of Knowing

CHAPTER OBJECTIVES The study of this chapter will help the learner to

Discuss the philosophical orientations that influence the choice of a research design. Contrast the characteristics of quantitative and qualitative research. Review the steps involved in the research process. Determine the way that a design is linked to the research question. Classify research based on characteristics related to intent, type, and time. Evaluate which kind of evidence is best provided by quantitative and qualitative research.

KEY TERMS Applied research

Basic research

Cross-sectional methods

Experimental research

Longitudinal studies

Mixed methods

Paradigm

Prospective studies

Qualitative research

Quantitative research

Quasi-experimental studies

Retrospective studies

Introduction What is the nature of truth? It is hard to think of a more difficult question to answer. This fundamental question must be considered, however, to ensure that the research process is successful in providing evidence for practice. Research is about the search for truth. There are, however, multiple approaches to determining and describing truth. The successful researcher

understands which approach is effective for the particular problem to be solved. The key is to consider assumptions about the nature of the world, the question to be answered, and the intent of the researcher.

The most fundamental questions to be answered in the beginning of a research process are philosophical but necessary ones: What constitutes knowledge? What is the nature of the world, and how can this research reflect that nature? The researcher should carefully consider these issues before proceeding with the design of the inquiry. It is a mistake to jump straight from research question to design without considering the philosophical foundation on which the study will be built.

These philosophical considerations must represent more than the researcher’s view of the world. That is, they must be carefully matched to a design that will address the specific nature of the research question. The goal is to produce knowledge that is relevant and applicable to the body of nursing knowledge and that becomes evidence for practice.

VOICES FROM THE FIELD When I started my doctorate, I was sure I wanted to do a straightforward quantitative experiment. I like numbers and statistics, so this kind of study seemed to be a natural extension of my interests. My subject, however, was a bit novel: I was trying to build a comprehensive model to measure inpatient nurse workload. I had always worked in hospitals and used patient acuity systems (systems used to measure the intensity of a patient’s care needs) to assess the nursing workload, but a nurse said something that intrigued me: “If all I had to do was take care of my patients, I’d be fine.” I set out to find out what all those other demands were, and how they affected the nurse’s perception of workload.

I found out just how novel this topic was when I tried to do a literature review and discovered that I could not find any relevant literature. There were lots of opinion articles about measuring workload, and plenty of published quantitative studies focused on patient acuity, but none tried to look at workload holistically. Reluctantly, I concluded that I needed to utilize a mixed-methods design—that is, I needed first to figure out what the forces affecting the nurse’s workload were, and then to measure how much impact they had on the nurse’s day.

I conducted a series of focus groups with nurses, observed them during their regular workdays, and interviewed quite a few individually. I found that I could describe many nonpatient demands—equipment needed repair, supplies were missing, and other therapists and technicians interrupted patient care. In addition, there were some macro issues at play: Nurses said that strong teams were able to accomplish more work, but weak teams actually created more pressure. All of the nurses

mentioned the effects of good leadership on recruitment and retention, and subsequently on the stability of the nursing staff, which helped build teams.

After theme analysis and triangulating the data from my focus groups, observations, and interviews, I developed a model of the demands on a nurse’s time. This preparation seemed to take forever, but when I finally began to test the model quantitatively, the work went quickly. I was able to determine the elements that directly affected workload and those that had an indirect effect. I figured out that teamwork, leadership, and retention were central to efficient unit operations. Demonstrating caring, communicating with team members, and entering information into the health record also consumed a lot of time. I discovered that “hunting for things” is a legitimate time drain.

This study was a classic case in which answering the research question required both quantitative and qualitative methods. The qualitative phase helped me determine the fundamental things that frustrate a nurse, and the quantitative phase let me demonstrate whether those influences were real and strong.

Janet Houser, PhD, RN

The Research Process Regardless of the philosophical assumptions made in a specific study, some characteristics are universal to all research studies. Research by its very nature is systematic and rigorous; it is about a disciplined search for truth. “Systematic” implies that decisions are carefully considered, options weighed, and a rational basis documented to support the choices that are made. Those decisions and choices help form the foundation for and build a research study. They also make up phases of study that are more or less completed in sequence. These phases are depicted in FIGURE 2.1:

Define a research problem: Identify a gap in the knowledge of nursing practice that can be effectively addressed with evidence. Scan the literature: Complete a systematic review of the literature to determine basic knowledge about the problem, so as to identify relevant evidence and a potential theoretical framework. Determine an appropriate design: Select a design that is appropriate for the philosophical assumption, the nature of the question, the intent of the researcher, and the time dimension. Define a sampling strategy: Design a sampling plan that details both how subjects will be recruited and assigned to groups, if appropriate, and how many subjects will be needed. Collect data: Gather the data using appropriate data collection protocols and reliable, valid methods.

Analyze data: Apply analytic techniques that are appropriate for the type of data collected and that will answer the question. Communicate the findings: Disseminate the findings to the appropriate audiences through conferences and publication. Use the findings to support practice: Promote the uptake of the research by linking it to specific guidelines for nursing practice.

FIGURE 2.1 The Research Process: Building a Study

These phases may look as if they make up steps, with the end of one phase leading directly to the beginning of another. It is, however, misleading to call the research process a series of steps. Such a description implies that the tasks are done in a particular sequence and that the components are distinct and mutually exclusive. In reality, the design of a research study is a fluid process, one that may be considered a work in progress until the final plan is complete. The process may resemble an elaborate game of Chutes and Ladders more than anything else. In this game, progress is made until the player reaches a chute, which will take the player back to a lower level. In research, several things may happen more or less at the same time—for example, the search for a theoretical framework, the literature review, and construction of the research question. Although the researcher may complete most of these tasks and move on to the design of the study, occasionally a situation will arise that prompts the researcher to reconsider the phrasing of the question, or new literature may be published. As a consequence, the phases may be conducted out of sequence, or the researcher may go back and forth between phases. The phases may overlap, or some phases may not be visited at all. So many varieties of research are possible that any depiction of the research process must come with the caveat that it is a general guide that is adapted to the particular situation at hand.

In quantitative research, decisions are usually finalized before data collection begins, although emergent issues may, even then, require adaptation of the research plan. In contrast, in qualitative research, the research plan is adapted based on both the data generated by the respondents and the nature of those data. Qualitative design decisions may not be completed until the final report is written.

In general, the way the research process emerges and the particular phases that are implemented in a research study are based on many characteristics of both the research problem and the researcher. These characteristics and assumptions lend themselves to several general classifications of research. The choice of an overall research classification is the first step in determining the specifics of a research design.

Classification of Research by Philosophical Assumptions About the Nature of the World The philosophical assumptions that drive the design of a study are rooted in the paradigms of those who are doing the studying. A paradigm is an overall belief system, a view of the world that strives to make sense of the nature of reality and the basis of knowledge. The disciplined study of nursing phenomena is rooted in two broad paradigms, both of which are relevant for nursing research. These two broad paradigms reflect methods that are primarily quantitative (based on the measurement of observable phenomena) or qualitative (based on the analysis of the meaning of events as depicted in the words and actions of others).

Paradigm: An overall belief system or way of viewing the nature of reality and the basis of knowledge.

Quantitative Research Quantitative research is the traditional approach to scientific research. It is rooted in the philosophical assumptions of positivism and determinism. Positivism assumes that features of the environment have an objective reality; the world is viewed as something available for study in a more or less unchanging form. A related assumption underlying the scientific method is determinism: a belief that events are not random, but rather have antecedent causes. In the face of these beliefs—the existence of an objective reality, in which events can be linked to an associated cause—the researcher’s challenge is to understand the relationships among human phenomena. The task of positivist scientific inquiry, then, is to make unbiased observations of the natural and social world.

Quantitative research: A traditional approach to research in which variables are identified and measured in a reliable and valid way.

Quantitative research involves identifying the variables that represent characteristics of interest and then measuring them in a reliable, valid way. This type of research is characterized by a tightly controlled context that enables the researcher to rule out extraneous effects. Both the way subjects are selected and the protocols for the study are designed to eliminate bias. Statistical analysis is used to establish the level of confidence in the results and to rule out the effects of random error. These conclusions, then, constitute the contribution to scientific knowledge.

There is no doubt that the scientific study of cause and effect in nursing practice is necessary and important for evidence-based practice; quantitative approaches are particularly well suited for answering questions about the nursing actions that can influence outcomes. These studies produce some of the strongest evidence for the benefits of an intervention. Nevertheless, nurses pose many questions that are not adequately addressed by a strict adherence to measurement of an objective reality. In turn, the single adherence to a positivist view has drawn considerable criticism from nurse researchers, and many of these criticisms are legitimate. The nature of nursing care involves helping others attain their health goals, many of which are defined by the individual, not the nurse. Perceptions of quality of life, the meaning of a life event, and the willingness to endure side effects for a therapeutic result are all based on the patient’s construction of reality, not the nurse’s perceptions. In turn, many related questions are better addressed with a process of naturalistic inquiry.

Qualitative Research Qualitative research is based on a naturalistic paradigm. This belief system is represented by a view of reality that is constructed by the individual, not the researcher. In the naturalistic view, reality is not a fixed entity, but rather exists in the context of what the research participant believes it to be. Qualitative researchers believe that many different views of reality are possible, and all of them are right. An associated belief for the naturalistic researcher is relativism, or the belief that there are always multiple interpretations of reality, and that these interpretations can exist only within an individual. The qualitative researcher, then, believes there is no process in which the ultimate basis for a singular truth can be identified.

Qualitative research: A naturalistic approach to research in which the focus is on understanding the meaning of an experience from the individual’s perspective.

Qualitative methods focus on an understanding of the meaning of an experience from the individual’s perspective. Extended observation of participants, in-depth interviews or focus groups, case studies, and studies of social interaction are examples of qualitative methods. The inquiry process

focuses on verbal descriptions and observable behaviors as a basis for analysis and conclusions.

Qualitative methods are appropriate for addressing questions in which the meaning of the patient’s experience is central to understanding the best therapeutic approach. Issues of behavior change, motivation, compliance with a regimen, and tolerance of a treatment are all examples of topics in which the patient’s perception is central to assisting the patient to a healthy state. The analysis of themes that describe the meaning of the experience for the patient is based on words and observations, rather than on measurable phenomena. The researcher establishes a relationship with the subject, and bias is considered an inherent part of the research process. The findings from qualitative studies are used to enhance evidence-based practice by incorporating the patient’s preferences and values into guides for nursing practice.

The differences in philosophy, roles, and methods between quantitative and qualitative research are depicted in Table 2.1. These contrasts are made to help the student understand the variations between these two overall approaches. In reality, both types of research have many characteristics in common:

A disciplined, rigorous approach based on external evidence Methods that require samples and the cooperation of individuals A focus on the rights of human subjects and ethical guidelines An ultimate aim of discovering new knowledge that can be used to improve nursing practice

Table 2.1 Quantitative Versus Qualitative Characteristics

Element Quantitative Qualitative

View of reality Reality is objective and can be seen and measured.

Reality is constructed by the individual.

View of time Reality is relatively constant. Reality is continuously constructed.

Context Reality can be separated from its context.

Reality is embedded in its context.

Researcher approach

Objective, detached. Personally involved.

Populations studied

Samples that represent overall populations as subjects.

Individual cases, represented as informants.

Measures Human behavior or other observable phenomena.

Study the meanings that individuals create.

Observations Analyze reality as definable variables.

Make holistic observations of the total context.

Design Preconceived and highly controlled. Emergent and fluid, adaptable to informants’ views.

Analysis Descriptive and inferential statistics. Analytic induction to determine meaning.

Generalization Use inference to generalize from a sample to a defined population.

Transfer knowledge from case analysis to similar cases.

Reports Objective, impersonal reports in which the researcher’s opinions are undetectable.

Interpretive reports that reflect the researcher’s reconstruction of the meaning of the data.

Many nurse researchers assume they must select only one approach and carry out the study in a pure and inflexible way. In fact, it is the rare study that relies on just one approach or the other. The choices made in research design are probably less about a solely qualitative approach versus a solely quantitative approach, and more about selection from a continuum of choices that may overlap from one approach to the other. Many quantitative studies involve asking the subjects to respond to questions or give opinions in which the participants’ words are later analyzed to enhance the statistical findings. Experimental researchers may rate subject behaviors using scales that contain subjective elements, or they may record their own observations of behaviors. Conversely, many qualitative studies use measurement to determine the reliability of multiple raters in determining themes and to verify the trustworthiness of conclusions. A basic qualitative validation method is triangulation, or the search for multiple sources to confirm the same finding, in which numbers are often retrieved to confirm verbal data. There are many situations in which a blend of methods is appropriate, and these mixed methods designs are becoming more common.

Mixed Methods Mixed methods are becoming an important tool in nursing research, particularly in evaluation research. Evaluation research is the application of research methods to the study of p rograms, projects, or phenomena. Increasingly, the question is not whether mixed methods are appropriate, but rather how they should be used.

Mixed methods: A research approach that combines quantitative and qualitative elements; it involves the description of the measurable state of a phenomenon and the individual’s subjective response to it.

Mixed-method designs can provide pragmatic advantages when exploring novel or complex nursing problems (McCusker & Gunaydin, 2015). The qualitative data provide a deep understanding of the human experience, while

the quantitative data enable the researcher to identify and measure relationships. Research that draws on the strengths of both paradigms is increasingly recognized as essential in all fields—including in medicine, where it is needed to support effective patient care guidelines.

Mixed methods are often applied in an ad hoc way, meaning the researcher initiates the study by using a primarily quantitative or qualitative method, and then integrates elements of the alternative approach as an afterthought. The most effective use of mixed methods, however, occurs when they are employed in a systematic way (Kettles, Creswell & Zhange, 2011). Mixed methods are commonly used in descriptive studies, where they may be used to describe both the measurable state of a phenomenon and the individual responses to it. For example, mixed methods might be used for the following purposes:

Describe the rate of hand washing on a nursing unit (quantitative) as well as the nurses’ perceptions about the importance of hand washing (qualitative) Measure the presence of bacteria on a nurse’s hands after washing (quantitative) and observe the hand-washing steps the nurse used (qualitative) Count the number of times a nurse washed his or her hands between patients (quantitative) and record the nurse’s report on the convenience of hand-washing facilities (qualitative)

Choosing a Design Many considerations go into the choice of a general approach to research design. The philosophical orientation of the researcher is just one element. The nature of the research question, the skills and abilities of the researcher, and access to resources and samples all are important elements to consider prior to choosing the research methodology.

Of primary importance to the selection of an approach is the nature of the research question. Research questions that focus on the effectiveness of an intervention require a scientific approach (assuming effectiveness is defined as an objectively measured outcome). For example, the effectiveness of a skin-care regimen in preventing pressure ulcers is best studied by applying the proposed regimen to one group of patients, applying a standard regimen to another group of patients, and then measuring the rate of pressure ulcer development in both groups. If the regimen is effective, then the subjects getting the new regimen will have a lower pressure ulcer rate than those with the standard regimen. This is the traditional experiment, and it is still one of the most common research designs in health care.

In contrast, research questions that focus on the acceptability of an intervention may require a qualitative approach. The new regimen may be

effective, but it may be painful, have an unpleasant smell, or consist of a cream that sticks to clothing. Assessment of these attributes, which will almost certainly affect whether a patient complies with the skin-care regimen, requires asking the patients about their preferences for the treatment and whether the outcome outweighs the unpleasant side effects.

Some of the considerations when choosing an approach are researcher driven. Many researchers have a personal preference for one approach over another. When the research question may be answered in several different ways, or when various aspects of a phenomenon require study before evidence can be deduced, then the researcher’s personal preference may drive the selection of an approach. The skills that are required for quantitative research include the capacity to define variables, recruit subjects, use random assignment methods, create reliable and valid measurements, and analyze results with statistical techniques. The skills that are required for qualitative researchers are quite different. They include the ability to find and select those subjects who can best inform the question, observe and record actions and interactions in detail, skillfully interview subjects or focus groups, and distill meaning from large amounts of word-based data. Both skill sets can require years to develop and hone. It is natural, then, that most researchers find themselves specializing in one approach or the other.

GRAY MATTER Consider the following elements prior to choosing a research design:

Philosophical orientation of the researcher Nature of the research question or problem Skills, abilities, and preferences of the researcher Resources and sample access

GRAY MATTER The following skills are required for quantitative research:

Defining variables Recruiting subjects Using random assignment methods Creating reliable and valid measurements Analyzing results with statistical techniques

GRAY MATTER The following skills are required for qualitative research:

Finding and selecting subjects appropriate for the question Observing and recording actions and interactions in detail

Interviewing subjects skillfully Distilling meaning from large amounts of word-based data

A host of practical considerations must be addressed when selecting an approach. Quantitative methods require measurement tools, subjects who are willing to undergo experimental treatments (or the risk of no treatment), statistical software, and access to individuals knowledgeable in statistical analysis and interpretation. Qualitative methods need less in the way of tools and software, but they require informants who are willing to be observed or interviewed, often for extended periods of time. The particular individuals who are accessible as well as the material resources required may drive the selection of a feasible research approach.

Theoretical considerations may also influence the selection of a specific design. The researcher may start the design process by deciding which concepts are of interest. The way these concepts interact with each other and create a framework is called a theory. Theoretical models are commonly tested with both quantitative and qualitative designs, and they provide a roadmap for future research. Theoretical and conceptual frameworks are the necessary backbone of a research study. Using a well-founded and well- referenced framework lends credence to the study, but, even more importantly, allows for comparisons across studies as well as building from or between studies. Basing a study on a sound theoretical framework is one way to ensure the research will be systematically designed.

A Note About Using Theoretical Frameworks in Nursing Research Theory is an attempt to explain the world around us. Nurses become part of the world of health care through an understanding of theories about nursing, which attempt to explain why nurses do what they do. Nursing care is a complex process, and explanations of human actions and interactions can be complicated and difficult to understand without a road map. Theory is a method of mapping these complex processes of human action and interaction that affect patient care and understanding their interrelationship.

The word theory comes from the Greek theoria, which means “vision.” Nurse scientists use theories to explain their visions of reality. Theories are not facts; instead, they are methods of posing what might be reality. Just as there are many visions of reality, so there are many theories that attempt to explain that reality. These theories often form the basis for research studies, in that many aspects of a conceptual model might potentially be the subject of study.

Nurse researchers also use theory as a framework for their studies. Developing a conceptual foundation involves a series of steps that

focus on the selection and definition of concepts, concept analysis, relational statements, and conceptual models of action and interaction. In this way, theoretical frameworks form the backbone of a research study. Using a strong framework lends credence to the study’s results, but more importantly allows for the replication of the study and the synthesis of its outcomes into guidelines.

Myriad thoughtful decisions must be made to choose the right approach for a particular research problem. The key word is thoughtful. These decisions should be based on a sound rationale, and the researcher should be able to articulate the basis for these decisions.

Classifications of Research by the Intent of the Researcher Research is classified by the basic belief system that drives its design features, but it must also reflect the intent of the researcher. There are two kinds of goals for research: (1) to provide new knowledge for the foundation of nursing and (2) to provide knowledge that can be immediately applied to the practice of nursing. The first of these is referred to as basic research; the latter is termed applied research.

Basic research is commonly referred to as theoretical, pure, fundamental, or bench research. One might think of the work done by scientists in laboratories as basic research. It is used to test theories and to build the body of knowledge that forms the foundation for practice, but it does not directly apply to the practice setting. Examples of basic research include measuring neuromuscular responses to stimuli and studying the effects of circulatory volume on neonatal cardiac function.

Basic research: Theoretical, pure, fundamental, or bench research done to advance knowledge in a given subject area.

Applied research is undertaken with the single goal of improving nursing practice. The findings from such research are intended to contribute in some way to a modification of nursing practice. Examples of applied research include investigating the effects of topical drugs on phlebitis and determining the efficacy of specific counseling techniques after the death of a spouse.

Applied research: Research conducted to gain knowledge that has a practical application and contributes in some way to a modification of practice.

Both basic and applied research may be conducted by using quantitative, qualitative, or mixed methods. Most clinical nursing research is considered applied research, and the findings that are generated as evidence for practice are exclusively of an applied nature. This is not to imply that basic research is not valuable. Indeed, one must have a clear understanding of the underlying theoretical and physiological basis for a given nursing practice to understand its mechanisms of effect.

Classifications of Research by the Nature of the Design Another classification of research is associated with the nature of the design. Experimental research refers to studies of cause and effect, which are usually undertaken to determine the effectiveness of an intervention. In an experimental design, some type of randomization method is employed to select subjects or assign them to groups according to how well they represent the population of interest. The researcher manipulates some aspect of the patient’s treatment in a highly controlled setting and compares the outcomes to those for a group that has received no treatment or a standard treatment. If the outcomes are different, the researcher assumes the difference is a result of the treatment because all other variables have been controlled. Experimental designs are characterized by highly structured protocols for sample selection and assignment, intervention, measurement, and analysis. Such designs aim to eliminate bias and control for rival explanations for the outcome.

Experimental research: Highly structured studies of cause and effect, usually applied to determine the effectiveness of an intervention. Subjects are selected and randomly assigned to groups to represent the population of interest.

Nonexperimental designs cover a broad range of studies that do not share these characteristics and, therefore, cannot test cause and effect. Quasi- experimental studies mimic experimental designs in most ways except for the selection and assignment of subjects. Such studies often use convenience samples or existing groups to test interventions. For example, a quasi- experimental study might test an intervention by selecting populations in two different nursing homes, where one group gets the treatment and the other does not. However, subjects are not assigned to the nursing homes randomly.

Quasi-experimental studies: Studies of cause and effect similar to experimental design but using convenience samples or existing groups to test interventions.

Other nonexperimental designs include descriptive research, correlation research, and predictive research. Descriptive research involves the study of a particular situation or event that already exists. The researcher does not manipulate any variables, although the study itself is systematic and thorough. Correlation research focuses on the existing relationships between variables. Such a study might, for example, search for a relationship between a single variable in two populations (e.g., do teens with mothers who had teen pregnancies have a higher teen pregnancy rate themselves?). Correlation studies might also search for relationships between two variables in the same sample (e.g., do overweight teens have higher pregnancy rates?). Predictive research takes the correlation aspect one step further, searching for relationships in which the values of one variable can be used to predict the values of another (e.g., do certain family characteristics predict the risk of a teen pregnancy?). Predictive research is particularly helpful in public health studies and research involving the determination of whether a risk factor will lead to a particular health condition.

Classifications of Research by the Time Dimension A final classification of research studies is by the time dimension chosen for the studies. These investigations may focus on the past or the future, referred to as retrospective and prospective studies, respectively.

Retrospective studies are conducted using data that have already been collected about events that have already happened. For nursing research, these data often come from chart review. In such a study, the researcher is unable to control most aspects of variable definition and data collection because those steps were performed before the study was conceived. The researcher conducting a retrospective study relies on the accuracy and completeness of these secondary data, or data that were originally collected for a purpose other than the research study. For example, a nurse might conduct a retrospective study to determine differences in the rate of ventilator- associated pneumonia between patients who received oral care every 4 hours and those who did not. The diagnosis of ventilator-associated pneumonia and the timing of oral care could both be retrieved from patient charts—a convenient source of reliable data. However, in this case, the nurse researcher is dependent upon the staff nurses’ documentation of the timing and extent of oral care. If the chart does not have a record of oral care in a 4-hour period, is it because such care was not provided or because it was not recorded? If oral care is recorded, was the care rendered according to current standards? The nurse researcher must balance the convenience of secondary data with the risks of inaccuracy and incompleteness of the data set.

Retrospective studies: Studies conducted using data that have already been collected about events that have already happened. Such secondary data were originally collected for a purpose other than the current research.

Prospective studies are those conducted by the researcher. This approach enables the researcher to control most aspects of research design and implementation, and primary data are collected (that is, data are collected by the researcher directly from subjects for the specific study at hand). Prospective studies are generally more reliable than retrospective studies due to the greater control afforded to the researcher. For example, a nurse might conduct a prospective study of oral care and ventilator-associated pneumonia by experimenting with different time periods, methods, or durations of oral care and measuring the rate of ventilator-associated pneumonia in the patients participating in the study. In this case, the procedures can be highly controlled and the outcomes reliably measured and recorded accurately. Such a study would be difficult to design and carry out, however, because of the need to address ethical questions, sampling challenges, and substantial time demands. The accuracy and completeness of data would be realized at the expense of considerable complexity and effort.

Prospective studies: Studies planned by the researcher for collection of primary data for the specific study and implemented in the future.

Studies may also be characterized based on whether they are conducted over time or at a single point in time. Such studies are referred to as longitudinal and cross-sectional studies, respectively.

Longitudinal studies are conducted over time—often very long time periods —to study the emergence of disease or the long-term effects of treatments. Subjects are followed over a period of time, with data collection occurring at prescribed intervals during that period. An advantage of longitudinal studies is their ability to determine the effects of risk factors or interventions over time. A disadvantage is the potential for attrition as subjects are lost to the study over its duration. There may also be effects from the act of repeatedly measuring the same individuals over time. An example of a longitudinal study would be monitoring the children of smokers over time to measure the emergence of pulmonary disease.

Longitudinal studies: Studies conducted by following subjects over a period of time, with data collection occurring at prescribed intervals.

Cross-sectional methods focus on collecting data at a single point in time. No follow-up is intended or built into the design. The result is a comprehensive picture of the existence of a phenomenon in the present, without concern for how it will look in the future. Cross-sectional methods often examine a single phenomenon across multiple populations at a single point in time. These

methods have the advantage that they are completed in a limited amount of time and may yield valuable information about how different populations respond to the same disease or treatment. Their primary disadvantage is that the effects of time are not evaluated and cannot be analyzed. An example of a cross-sectional study would be determining the prevalence and distribution of pulmonary diseases in a sample of children who have a parent smoker in the home at a given point in time.

Cross-sectional methods: Studies conducted by looking at a single phenomenon across multiple populations at a single point in time, with no intention for follow-up in the design.

Longitudinal and cross-sectional studies are frequently used in public health and epidemiology to study the distribution and determinants of disease over time or across populations. These methods can also be used in nursing research to study the effects of risk factors, interventions, or nursing practice changes as they unfold at different times and for different people.

Reading Research for Evidence-Based Practice Although it is relatively easy to categorize research by its approach, type, time dimension, and other distinctions in a research textbook, in reality these distinctions are not quite so tidy or clear-cut. Reading a research study while trying to classify its characteristics often results in frustration. Just as the research process must be viewed as a fluid process that articulates decisions made on a continuum, so reading a research study challenges the nurse not to determine whether the right design has been selected, but whether the researcher has made the right choices.

Often, in the introduction of a study, qualitative researchers will make explicit their reasons for choosing a particular design. In general, a qualitative study will state that it is a qualitative approach somewhere in the abstract, introduction, or initial methods sections. This is not usually the case with quantitative research. Instead, it is often up to the reader to determine the specific decisions the researcher made and to try to deduce the reasoning behind those decisions.

The reader can pick up some hints early in the abstract and the methods section that will provide clues about the time dimension of the study. Comments about the use of “secondary data” or “using data collected for another study” will indicate the study is retrospective. In this case, the critical reader should be looking for evidence that the researchers accounted for the lack of accuracy and specificity that accompanies retrospective studies, or at least acknowledged its existence. Researchers will rarely identify primary data explicitly as such, but the inclusion of an intervention protocol or a measurement procedure indicates that the data were prospectively gathered.

It is usually relatively easy to determine whether a study is longitudinal or cross-sectional. The reader can look for measures that were collected repeatedly on the same individuals as a clue that a study is longitudinal. The researcher might use terms such as paired sample, dependent data, or repeated measures to indicate that data were collected over time from the same subjects. If it is clear that data were collected once from individuals at a single point in time, then the study is a cross-sectional one.

It is important to categorize the type of study before using it as evidence. The hierarchy of evidence encompasses a variety of research designs, but the connection to the strength of a practice recommendation is based, to a great extent, on the type of study. Listed here are some of the points to appraise when reading a research study to determine whether the authors used the appropriate approach:

Does the research question match the specific approach that was chosen? If an intervention was tested, was a quantitative approach used? If patient preferences and values were assessed, was a qualitative method or a mixed method used? Does the researcher articulate a rationale for decisions about the research approach? Does the author provide logical reasoning for the specific design selected? If not, can it be deduced from the characteristics of the study?

The initial review of a research study for its approach, type, and time dimension is useful in determining the level of evidence that its findings represent. This assessment ensures that the nurse will use the research results appropriately in supporting evidence-based nursing practice.

Using Research in Evidence-Based Practice Although it would seem obvious that applied research is the most helpful for evidence-based practice, basic research may also be used for this purpose. The hierarchy of evidence considers basic research about physiology and pathophysiology to be legitimate considerations in making practice decisions, on par with professional expert opinion and descriptive research. When developing a research-based practice guideline, a good starting place is a basic foundation of the existing knowledge about the physiological and psychological forces that may be in play in a given nursing practice situation.

The results of both quantitative and qualitative research are useful in evidence-based practice. Although randomized controlled trials (experimental designs)—both singularly and in aggregate—clearly provide the strongest evidence for practice, they do not provide the only evidence for practice. Well- designed quasi-experimental, descriptive, correlation, and predictive designs can provide evidence that can be used to determine whether an action can be designated as recommended, optional, or not recommended.

Qualitative and mixed methods are primarily useful in determining the preferences and values of the patient. They may, however, be used to theorize which interventions might be effective, particularly when little research is found or when the research topic deals with behavioral, psychological, or spiritual issues. Exploratory studies often give rise to theories that subsequently can be tested with quantitative methods, improving on the evidence for practice. The best practice guidelines are those that incorporate a variety of research studies and methods into a single guideline so the needs of patients can be addressed in a comprehensive, evidence-based manner.

Creating Evidence for Practice Given all these approaches, types, and dimensions of research, outlining a specific research study may seem daunting. A systematic approach to making the decisions that are required, however, helps narrow the choices relatively quickly and makes the process a manageable one. Using criteria for each step in the decision-making and design process can help ensure that the right choices are made for the right reasons.

Criteria for Selecting an Approach The primary consideration when selecting an approach is ensuring a match between the problem and the approach chosen to provide a solution. If the question is one that relates to the effectiveness of an intervention, identifies factors that influence a patient’s outcome, or finds the best predictors for a patient’s condition, then clearly a quantitative approach is needed. If the problem is one that requires an in-depth understanding of the patient’s experience and the meaning of a phenomenon, then qualitative research is required. Either approach may be used for exploratory research or when there is little existing research. However, a qualitative or descriptive study is often a good way to start an exploration of a phenomenon for which little or no existing literature is available.

Mixed methods are the best way to capture the outcomes of both approaches. Mixed methods are complex, however, and require that the researcher have a command of both quantitative and qualitative research skills. It is rare that a novice researcher would undertake a mixed-method study to address a single problem. Instead, mixed methods are often reserved for evaluation of complex issues or for developing and testing models of action and interaction.

A careful self-assessment of personal experiences and abilities will also help the researcher arrive at a feasible study method. Time devoted to reflection about one’s propensity toward quantitative or qualitative methods is time well spent in preparing for a research study. Using a method that is not compatible with the researcher’s nature can be frustrating and result in poorly executed research. If a researcher knows that a particular approach is difficult for him or her to apply, then the nurse may want to join a research team to learn more about the process and to gain the mentorship and support that comes from

individuals who are competent in and passionate about the approach. A pragmatic self-assessment of available time, software, resources, and competency is also useful before arriving at a conclusion about a study design.

Finally, the nurse researcher should consider the expectations of the audience he or she is trying to reach. That audience may include fellow nurses, healthcare team members, or administrators. The nurse researcher would also do well to consider other audiences that must be addressed to communicate the results effectively, such as journal editors, conference attendees, graduate committees, or professors. The needs and interests of these audiences may be as important as those of fellow practitioners when it comes to ensuring that the research results are communicated broadly enough to be used in practice.

Summary of Key Concepts Research is about the search for truth, but there are multiple ways to determine and describe truth. The key to a successful research process is to understand which approach is appropriate for the particular problem to be solved. The research process is a fluid, dynamic one that includes multiple processes. These processes may occur in sequence, or they may overlap; some phases may even be skipped. The phases in the research process include defining the research problem, scanning the literature, selecting a theoretical framework, determining an appropriate design, defining a sampling strategy, collecting and analyzing data, communicating the findings, and using the findings to support practice. Philosophical assumptions drive the fundamental design of a study and are rooted in the paradigms of quantitative or qualitative methods. Quantitative studies employ measurement to produce an objective representation of relationships and effects. Qualitative studies use verbal reports and observations to arrive at an interpretation of the meaning of a phenomenon. Mixed methods may involve elements of both quantitative and qualitative research, but the standards for both approaches must be met. Mixed methods are most effective for evaluation research and for developing and testing models of action and interaction. A design should be chosen based on the nature of the research question and the preferences and skills of the researcher, as well as practical considerations such as access to subjects, software, and other resources. Research can be classified by the intent of the researcher. Basic research reflects an intent to contribute to the fundamental body of knowledge that is nursing. Applied research reflects the sole intention of providing evidence that can be directly applied to the practice of nursing. The nature of research design can be categorized as experimental or nonexperi-mental. Experimental designs are highly controlled, with a goal of testing cause and effect. Nonexperimental designs can be descriptive,

correlative, or predictive. Both types of designs provide evidence for nursing practice, but the recommendations from experimental designs are considered stronger. Research can be categorized by its time dimension as retrospective or prospective. Retrospective studies use secondary data that have already been collected. Prospective studies use real-time processes to collect primary data explicitly for the study. Studies can also be classified as longitudinal or cross-sectional. Longitudinal studies measure some aspect of the same subjects over time, whereas cross-sectional studies measure a characteristic from multiple populations at a single point in time.

For More Depth and Detail For a more in-depth look at the concepts in this chapter, try these references:

Creswell, J. (2013). Research design: Qualitative, quantitative, and mixed methods approaches. Thousand Oaks, CA: Sage.

Lee, S., & Smith, C. (2012). Criteria for quantitative and qualitative data integration: Mixed methods research methodology. CIN: Computers, Informatics, Nursing, 30(5), 251–256.

Merriam, S., & Tisdell, E. (2015). Qualitative research: A guide to design and implementation(4th ed.). San Francisco, CA: Jossey-Bass.

Patton, M. (2014). Qualitative research and evaluation methods: Integrating theory and practice. Thousand Oaks, CA: Sage.

Perreault, K. (2011). Research design: Qualitative, quantitative, and mixed methods approaches. Manual Therapy, 16(1), 103.

Vogt, W., Gardner, D., & Haeffele, L. (2012). When to use what re search design. New York, NY: Guilford Press.

Walsh, K. (2011). Quantitative vs qualitative research: A false dichotomy. Journal of Research in Nursing, 17(1), 9–11.

CRITICAL APPRAISAL EXERCISE Retrieve the following full-text article from the Cumulative Index to Nursing and Allied Health Literature or similar search database:

Kolehmainen, N., Ransay, C., McKee, L., Missiuna, C., Owen, C., & Francis. J. (2015). Participation in physical play and leisure in children with motor impairments: Mixed-methods study to generate evidence for developing an intervention. Physical Therapy, 95(10), 1374–1386.

Review the article, focusing on the design of the study. Consider the following appraisal questions in your critical review of this research article:

1. What is the author’s rationale for using mixed methods for the study of this subject?

2. Discuss the link between the purpose of the study and this specific design.

3. Classify this study with respect to each of the following dimensions:

The intent of the researcher The type of study The time dimension of the study

4. Which characteristics did this study possess that were quantitative in nature?

5. Which characteristics did this study possess that were qualitative in nature?

6. Describe the reasons you think a mixed-methods approach was the most appropriate for this population and research goals.

References Kettles, A., Creswell, J., & Zhange, W. (2011). Mixed methods

research in mental health nursing. Journal of Psychiatric and Mental Health Nursing, 18, 535–542.

McCusker, K., & Gunaydin, S. (2015). Research using qualitative, quantitative or mixed methods and choice based on the research. Perfusion, 30(7), 537–542.

Chapter 3: Ethical and Legal Considerations in Research

CHAPTER OBJECTIVES The study of this chapter will help the learner to

Describe fundamental ethical concepts applicable to human subjects research. Discuss the historical development of ethical issues in research. Describe the components of valid informed consent. Identify the features of populations that make them vulnerable in a research context. Discuss statutes and regulations related to conducting clinical research. Describe the history, functions, and processes related to the institutional review board. Identify the three levels of review conducted by institutional review boards. Relate protections for human subjects to guidelines for animal welfare in research. Discuss the major provisions of the privacy rule (HIPAA) that affect data collection for research.

KEY TERMS A priori

Beneficence

Ethics

Exempt review

Expedited review

Full disclosure

Full review

Health Insurance Portability and Accountability Act (HIPAA)

Informed consent

Institutional review board (IRB)

Justice Nontherapeutic research

Respect for persons

Right of privacy

Therapeutic research

Vulnerable populations

Introduction Ethics is the study of right and wrong. It explores what one might do when confronted with a situation where values, rights, personal beliefs, or societal norms may be in conflict. In everyday life, we are often faced with ethical situations when we must ask a key question: What is the right thing to do in this particular situation?

Ethics: A type of philosophy that studies right and wrong.

Ethical considerations tell us how we should conduct research. These directives for the ethical conduct of nursing research are guided by the researcher’s integrity and applied through personal decision making. Legal guidelines, in contrast, tell us how we are required to conduct research. These guidelines are found in laws and regulations that are provided by agencies external to the nurse researcher. Ethics and legal considerations are often inextricably intertwined. In the end, it does not matter if an ethical guideline or a legal regulation provides guidance to the nurse researcher: They are equally important for quality research.

Researchers face ethical and legal situations in almost every step of the research process, from selecting participants to collecting data to reporting findings at the conclusion of the study. The ethics of human subjects research and international and federal control over such research, however, have evolved since the mid-twentieth century. Professional organizations and international associations alike have developed codes of ethics that apply to research involving human subjects. In this chapter, the ethical foundation of research is examined, considering both recent and remote examples of scientific transgressions that helped form current research practices. What society has legislatively imposed in the context of research regulation is discussed as well.

Learning from the Past, Protecting the Future When humans participate as subjects in research studies, care must be taken to preserve their rights: their right to be informed of the study process and potential risks, their right to be treated in a fair and transparent manner, and their right to withdraw from a study at any time for any reason without question or negative consequences (Franklin, Rowland, Fox & Nicolson, 2012).

Unfortunately, breaches of ethical conduct have a long history. In the aftermath of World War II, disclosure of Nazi experimentation on prison camp detainees revealed the need for consideration of basic human rights in research involving human subjects. In the United States, the revelation of the deception and nontreatment of men of color with syphilis during the Tuskegee syphilis study (1932–1972) led to long-lasting mistrust of the medical research community, and has limited researchers’ ability to recruit diverse populations for medical studies. The Willowbrook Study (1963–1966) engendered particular outrage because its subjects were mentally handicapped children; it led to improved protections for children and other vulnerable populations within the research context. Unfortunately, ethical breaches are not solely of historical interest: The Gelsinger case at the University of Pennsylvania and the Roche case at Johns Hopkins Asthma and Allergy Center occurred long after healthcare organizations had enacted standards for ethics in research. These cases (discussed later in this chapter) illuminate the fact that any research involving human subjects always requires careful consideration of the rights of those subjects.

Although the primary investigators for these research activities were physicians, evidence suggests that nurses were aware of deceit in recruitment and delivery of non-therapeutic treatment, at least during the Tuskegee syphilis study. Why are these events historically important to nurses? Reflection and careful thought about the roles of nurses in research—from observer to data collector to principal investigator—and the responsibility nurses have to humankind mandate that we learn from the past and, in doing so, protect the future.

VOICES FROM THE FIELD As soon as I identify an idea for a research project, I start thinking about the legal implications of this study or how this study will look in the eyes of our institutional review board (IRB). When I was a novice researcher, the IRB seemed like a big hurdle to overcome. Now that I am an experienced researcher, I view it as a significant asset to the research process.

The IRB is made up of a wide variety of professionals who evaluate a study from their area of expertise. There is a lot of research experience on the IRB. Its members pay particular attention to the risks and benefits of each study, and it is clear their focus is on protecting the rights of subjects. But they can also give you excellent advice and suggestions to make your study stronger and ensure it is ethical. They also give good feedback about the soundness of the overall study design and the ability of the study team to perform this particular research.

This became very clear to me when I had to consider the legal implications of a recent study that I helped design. The study itself

seemed quite benign. The research question was, “Do two 15-minute foot massages done on two consecutive days decrease anxiety in inpatient cancer patients?” We chose to answer this question using a randomized controlled trial (RCT) study design. The two co-primary investigators (PIs) were bedside nurses on our inpatient cancer unit who cared deeply about their patients and wanted to do a study on ways to help lessen the stress of being hospitalized. The study team included an oncologist who was also the chief of oncology services, several clinical nurse specialists, the unit director, an experienced massage therapist, and me in my role as medical epidemiologist and nurse researcher. As a team, we designed a study that we felt adequately addressed our study question.

The IRB saw it differently. They were concerned that we had not adequately addressed the risks of a foot massage; although rare, they still needed to be expressed in both the protocol and the consent process. We needed to inform potential subjects that there was a risk of dislodging a clot, causing severe pain or discomfort, or irritating or damaging the skin. Further, the board suggested that our control group (no massage) would be a better comparison group if we offered some type of therapeutic nurse interaction for the same amount of time as our foot massage. This would help overcome any placebo effect from the treatment. They had concerns about our measurement tools and our enrollment methods as well. Our simple little study suddenly wasn’t so simple—and we had to admit their suggested changes would improve the study in a lot of ways.

Instead of becoming discouraged, we took the IRB’s recommendations to heart and began to redesign our study. We realized we needed to better communicate how we had identified and addressed risks in our IRB documents, so we rewrote our consent form. We asked for advice from a variety of sources and wrote a better protocol that included a comparison therapy. We identified a stronger instrument and cleaned up our sampling procedure. In retrospect, I’m relieved we were stopped when we were—we honestly hadn’t considered the risks carefully enough, and the IRB made us do that.

In retrospect, we should have asked for feedback from clinical and scientific colleagues outside of our team before submitting our project for IRB review—a lesson learned. Even though it was small and seemingly benign, we needed to be more aware of the risks involved.

Joanna Bokovoy, RN, DrPH

Medical Epidemiologist

Nazi Medical Experimentation

From 1933 until 1945 and the liberation of the death camps in Europe, atrocities were inflicted on World War II concentration camp detainees in the name of science. As part of the goal of advancing the Third Reich in Europe, the Nazis conducted medical experiments whose results were intended to be used to produce a race of pure Aryans who would rule the world.

Under the guise of benefiting soldiers of the Third Reich, Nazi physicians carried out experiments to test the limits of human endurance. For example, prisoners were submerged for days at a time in a tank of cold water. The intent was to test how long German pilots, who had to parachute into the cold North Sea, would survive. Different types of clothing were tested, as well as different methods for resuscitating the experimental subjects who survived. Other prisoners were burned with phosphorus to track wound healing. Surgery was performed without anesthesia to gauge pain levels, in utero surgery was carried out to determine fetal growth and development during stages of pregnancy, and surgical gender changes were accomplished. Many of the subjects of these experiments did not survive.

These experiments were not randomly carried out by only a few scientists; instead, they were regarded as fulfillment of governmental policy in support of the war effort. These atrocities in the name of scientific experimentation made it clear that international oversight of the rights of human subjects in research was necessary.

The Tuskegee Study It is tempting to consider the Nazi studies to be examples of outrageous acts that could not occur in our own society. Unfortunately, the U.S. Public Health Service has its own record of egregious treatment of experimental subjects.

In 1932, the Public Health Service initiated a study to determine the natural history of syphilis. Called the “Tuskegee Study of Untreated Syphilis in the Negro Male,” the study initially involved 600 black men—399 with syphilis and 201 without. The study was conducted without obtaining the informed consent of the subjects. While the subjects were led to believe they were being treated for a blood disorder, in reality the progress of their syphilis was allowed to unfold without treatment. Although originally projected to last 6 months, the study went on for 40 years. In 1972, a news story about the study caused a public outcry that led the government to appoint an ad hoc advisory panel to investigate the study. The panel concluded that the Tuskegee Study was “ethically unjustified” and ordered reparations for the men and their families (Centers for Disease Control and Prevention, 2011).

The Willowbrook Study Lest we rationalize these examples of inhumane treatment of research subjects as affecting only adults, the Willowbrook study, conducted from 1963 to 1966, provides an example of research in which children were the target.

The study’s conduct was doubly egregious because these children—residents of a state-run school for children with learning disabilities—were also mentally compromised. The stated purpose of the study was to determine the course of untreated hepatitis. At the time, the school was supposedly not accepting new students, but it admitted additional children whose parents were willing to enroll them in the study. This policy introduced an added element of influence: If the school accepted only children whose parents agreed to their participation in the study, it may have put pressure on those parents who had few options for caring for their children and were desperate for state assistance.

Reports allege that the children in the Willowbrook study were deliberately infected with the hepatitis virus—some by being fed extracts of stools from known infected children, and later by injection. After a period of observation during which the children were untreated, a vaccine was tested on the subjects.

In some circles, the value of this study is still heavily debated. On the one hand, it did, indeed, result in development of the hepatitis vaccine used today. On the other hand, highly vulnerable children were infected with hepatitis, and the voluntary nature of their parents’ consent is questionable (Hardicre, 2014).

All of these episodes raised concerns about the need to protect the rights of human subjects. As a result of these violations of basic human rights, both international and national guidelines for the ethical treatment of research subjects were developed.

International Guides for the Researcher Two major international codes and reports guide researchers in carrying out ethical research: the Nuremberg Code and the Declaration of Helsinki.

The Nuremberg war crimes trials, which were held from 1945 to 1947, focused on crimes against humanity. They were presided over by judges from the four Allied powers— the United States, Great Britain, France, and the Soviet Union. The city of Nuremberg, Germany, was purposely chosen as the site for the trials because, after 11 Allied air strikes during the war, the city was declared 90% dead. During the trials, a large-scale prosecution of Nazi officials took place, many of whom presented as a defense the notion that they were simply following their superiors’ orders. Their crimes included inhumane acts on civilians, initiating and waging aggressive acts of war, murder, near extermination of a race, slavery, ill treatment of prisoners, plunder, and destruction.

In response to the revelations in these trials, the Nuremberg Code was developed in 1949. This code contained guidelines requiring voluntary, informed consent to participate in medical experimentation. It further specified that the research must serve a worthy purpose, that the desired knowledge

must be unobtainable by other means, and that the anticipated result must justify the performance of the experiment. All unnecessary physical and mental suffering was to be avoided. A little known fact is that the Nuremberg Code led to the notion of substituting animal experimentation in advance of or in lieu of human experimentation. This later raised concerns about the humane treatment of animals, a topic discussed later in this chapter.

The Nuremberg Code further guaranteed that no experiments were to be permitted when death or disability was an expected outcome, “except, perhaps, in those experiments where the experimental physicians also serve as subjects.” Risks were to be commensurate with the importance of the problem, and human subjects were to be protected from even a remote possibility of harm. Experiments were to be conducted only by properly qualified scientists, and the subject had the right to stop the experiment at any time. Further, the scientist in charge was obligated to stop the experiment if injury, disability, or death was likely to result. The code may be viewed online at https://ori.hhs.gov/chapter-3-The-Protection-of-Human-Subjects- nuremberg-code-directives-human-experimentation.

GRAY MATTER The Nuremberg Code, developed in 1949, contains research guidelines stipulating that:

Consent is voluntary and informed for subjects who participate in medical experimentation. The research serves a worthy purpose. The knowledge gained is unobtainable by any other means. The anticipated results justify performance of the experiment. Unnecessary physical and mental suffering or harm is avoided. Death or disability is not an expected outcome. Properly qualified scientists conduct the experiments.

The Declaration of Helsinki—an extension of the Nuremberg Code—was adopted in 1964 by the World Medical Association and amended and updated most recently in 2008. The Declaration of Helsinki expanded the principles of the Nuremberg Code to differentiate between therapeutic research and nontherapeutic research. Therapeutic research is expected to confer on the study subject an opportunity to receive a treatment that might be beneficial. Nontherapeutic research is carried out for the purpose of generating knowledge and is not expected to benefit the study subject, but might lead to improved treatment in the future.

Therapeutic research: Studies in which the subject can be expected to receive a potentially beneficial treatment.

Nontherapeutic research: Studies that are carried out for the purpose of generating knowledge. They are not expected to benefit the research subject, but may lead to improved treatment in the future.

Similar to the Nuremberg Code, the Declaration of Helsinki requires informed consent for ethical research, while allowing for surrogate consent when the prospective research subject is incompetent, physically or mentally incapable of providing consent, or a minor. Furthermore, the Declaration of Helsinki states that research within these groups should be conducted only when this research is necessary to promote the health of the representative group and when this research cannot otherwise be performed on competent persons.

National Guidelines for the Nurse Researcher In 1974, Congress passed the National Research Act, which resulted in the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. As part of their work, members of the national commission wrote the Ethical Principles and Guidelines for the Protection of Human Subjects of Research report. Commonly known as the Belmont Report, this document, which was published in 1978, has become the cornerstone statement of ethical principles on which regulations for protection of human subjects are based (U.S. Department of Health, Education, and Welfare [HEW], 1978).

The Belmont Report (which can be viewed online at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html) begins by stating, “Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions. Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments. . .” (HEW, 1978, p. 1). As a result, state and national regulations, as well as international and professional codes, have been developed to guide researchers. These rules are based on broader ethical principles that provide a framework to evaluate investigators’ judgment when designing and carrying out their research. Three foundational ethical principles relevant to the ethics of human subjects are described in the Belmont Report: respect for persons, beneficence, and justice.

Respect for Persons Respect for persons, the first principle, incorporates two ethical convictions: that individuals should be treated as autonomous beings capable of making their own decisions, and that persons with diminished autonomy or those not capable of making their own decisions should be protected. The extent of protection afforded to those incapable of self-determination will depend on the risks, harms, and benefits of the study. Consequently, the principle of respect for persons is divided into two separate moral requirements: the requirement

to acknowledge a person’s autonomy and the requirement to protect those individuals with diminished autonomy.

Respect for persons: A basic principle of ethics stating that individuals should be treated as autonomous beings who are capable of making their own decisions. Persons who have limited autonomy or who are not capable of making their own decisions should be protected.

Persons with diminished autonomy sometimes are regarded as vulnerable or as a member of a vulnerable population. These groups may contain some individuals who possess limited autonomy (that is, they cannot fully participate in the consent process)—for example, children, individuals with dementia and other cognitive disorders, prisoners, and pregnant women. Some ethicists regard older persons, terminally ill persons, and other hospitalized persons, as well as those who are homeless, students, or transgender, as also deserving of special consideration by researchers. Researchers have a special obligation to ensure a study involving vulnerable populations is ethical. However, Lange, Rogers, and Dodds (2013) argue that a description of the features that makes a group vulnerable is more helpful than labeling actual population groups. These authors offer a simple standard for identifying such individuals: Vulnerable subjects are those who are especially prone to harm or exploitation.

Vulnerable populations: Groups of people with diminished autonomy who cannot participate fully in the consent process. Such groups may include children, individuals with cognitive disorders, prisoners, and pregnant women.

Under this definition, identifying vulnerable populations becomes a much broader task. For example, refugees, the bereaved, persons with dementia, alcoholics, persons with disabilities, and persons diagnosed with mental illness could all be considered vulnerable and deserving of special protection. The challenge is to illuminate the needs of these vulnerable patients—many of whom could benefit greatly from population-specific research—while respecting their integrity and minimizing their risks from participating in such research (Nordentoft & Kappel, 2011).

Special consideration for research studies that may include vulnerable populations involve ensuring the following protections:

The risks of participating would be acceptable to volunteers in the general public. Selection of subjects is fair and unbiased.

The written consent form is understandable given the subject’s expected level of function and comprehension. Adequate follow-up is provided (Juritzen, Grimen & Heggen, 2011).

Beneficence One of the most fundamental ethical principles in research is beneficence— that is, “do no harm.” According to the Belmont Report, “Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Two general rules have been formulated as complementary expressions of beneficent actions: (1) do no harm and (2) maximize possible benefits and minimize possible harms” (HEW, 1978, §B.2).

Beneficence: A basic principle of ethics that states that persons should have their decisions respected, be protected from harm, and have steps taken to ensure their well-being.

Human subjects can be harmed in a variety of ways, including physical harm (e.g., injury), psychological harm (e.g., worry, stress, and fear), social harm (e.g., loss of friends or one’s place in society), and economic harm (e.g., loss of employment). Researchers must strive to minimize harm and to achieve the best possible balance between the benefits to be gained from participation and the risks of being a participant.

The Belmont Report tells us that the assessment of the risks and benefits of a study presents an opportunity to gather comprehensive information about the proposed research. The investigator strives to design a study that will answer a meaningful question. A review committee will determine whether risks inherent in participation are justified. Prospective subjects will make an assessment, based on their understanding of risks and benefits, as to whether to participate in the study.

Justice The third broad principle found in the Belmont Report is justice. The principle of justice incorporates participants’ right to fair treatment and fairness in distribution of benefit and burden. According to the report, an injustice would occur when a benefit to which a person is entitled is denied or when some burden is unduly imposed. For example, the selection of research subjects needs to be closely scrutinized to determine whether some subjects (e.g., welfare recipients, racial and ethnic minorities, or persons confined to institutions) are being systematically selected because of their easy accessibility or because of their compromised position. The application of justice also requires that research should not unduly involve persons from groups unlikely to be beneficiaries of the results of the research. However,

members of diverse groups also should be included, and not excluded, without a prior knowledge of their suitability to participate.

Justice: A basic principle of ethics that incorporates a participant’s right to fair treatment and fairness in distribution of benefit and burden.

GRAY MATTER During research, human subjects can suffer harm in the following ways:

Physically (injury) Psychologically (worry, stress, or fear) Socially (loss of friends or place in society) Economically (loss of employment)

Certain diverse groups, such as minorities, the economically disadvantaged, the homeless, the very sick, and those persons who have a compromised ability to provide consent, should be protected against the danger of being recruited for a study solely for the researcher’s convenience. In short, this means that researchers may not take advantage of underprivileged persons so as to benefit those who are privileged.

Table 3.1 Ethical Principles and Research Design

This Ethical Principle Is Managed with This Design Principle

Respect for persons Informed consent process Subject selection process Adequacy of follow-up systems

Beneficence Assessment of risk and benefit

Justice Subject selection process

Table 3.1 links the ethical principles to the elements of research design. In addition to these ethical principles, some values are recognized as fundamental to the scientific enterprise as a whole. These concepts go beyond the ethical treatment of subjects and address the ethical behavior of the researcher. The primary values that are the focus of the entire research process include truthfulness, trust, and best interests. Related values include carefulness, openness, freedom, credit, education, social responsibility, legality, opportunity, and mutual respect (Horner & Minifie, 2011a).

The ethical nurse researcher considers all these principles as a research study is being designed and adheres to these values as the research is being

carried out. The failure to identify and resolve ethical issues can place both the conduct and the results of a research study in jeopardy (Milton, 2013).

The Ethical Researcher Bad behavior in the name of science has given rise to the need for laws, regulations, and safeguards. The public’s perception of research, its benefits, and its risks is shaped by the way research is conducted and by the way results are reported. Researchers, then, should abide by the ethical guidelines cited in the Nuremberg Code, the Belmont Report, and the Helsinki Declaration. Additionally, other guidelines have been developed that are specific to research funded by the federal government or foundations.

Table 3.2 summarizes the responsibilities of an ethical nurse researcher. Such researchers abide by ethical guidelines so as to uphold the public’s confidence in research and its contribution to knowledge for the greater good. These guidelines declare that the ethical researcher should honor the following criteria:

Adhere to principles of beneficence by doing no harm, maximizing benefits, and minimizing possible harms Respect the autonomy of the participants in the consent process Employ the principle of justice in subject selection Explain the research procedures to the participants Obtain proper and informed consent Ensure the confidentiality of participants Maintain appropriate documentation of the research process Adhere to research protocols Report results in a fair and factual manner (National Academy of Sciences, 2009)

Table 3.2 Responsibilities of an Ethical Nurse Researcher

To respect individuals’ autonomy in consenting to participate in research

To protect those prospective subjects for whom decisional capacity is limited

To minimize potential harm and to maximize possible benefits for all subjects enrolled

To ensure that benefits and burdens associated with the research protocol are distributed equally when identifying prospective subjects

To protect privacy, to ensure confidentiality, and to guarantee anonymity when promised

To notify institutional officials of breaches of research protocols and incidents of scientific misconduct

To maintain competence in one’s identified area of research

To maintain proficiency in research methods

One way to ensure that the researcher conducting a study meets these criteria is to select the most appropriate participants for the study. The study subjects must also understand their role in the research. The most important aspect of this process is to secure the participants’ informed consent.

Informed Consent Informed consent encompasses much more than just a form or a signature; rather, it is a process of information exchange that includes recruitment materials, verbal dialogue, presentation of written materials, questions and answers, and an agreement that is documented by a signature. According to the Belmont Report, the consent process contains three components: information, comprehension, and voluntariness. Participants should be able to ask questions, understand the risks and benefits, and be assured that if they choose to participate they may withdraw at any time without consequences.

Informed consent: A process of information exchange in which participants are provided with understandable information needed to make a participation decision, full disclosure of the risks and benefits, and the assurance that withdrawal is possible at any time without consequences. This process begins with recruitment and ends with a signed agreement document.

To judge how much information should be disclosed to a prospective subject, the “reasonable subject” standard should be used. This standard requires that the extent and nature of the information provided be sufficient for a reasonable person to decide whether to participate (Odeh, 2013).

Organization of the Informed Consent Prospective subjects who are fully informed about the nature of the research and its associated risks and benefits are positioned to make an educated decision about whether to participate. Essential content for informed consent in research can be found in the U.S. Department of Health and Human Services’ Code of Federal Regulations (CFR 45, Part 46.106). Information that is essential for informed consent can be found in Table 3.3.

Table 3.3 Elements of the Informed Consent Form

Title of study and name(s) of investigator(s)

Introduction and invitation to participate

Basis for selection

Explanation of study purpose and procedures

Duration of participation

Reasonably foreseeable risks/unforeseen risks

Benefits of participation/cost of participation

Appropriate alternatives to participation

Voluntary withdrawal from study

Payments/compensation

Confidentiality of records

Contact person

Funding statement/conflict of interest statement

Statement of voluntary participation

Signature lines

Deception or Incomplete Disclosure When explaining the research procedures to the prospective subject, the researcher must explain all information that is known about risks and benefits. The subject needs to know if the treatment, drug, or procedure used in the study is not necessary for his or her care and if it may have outcomes that are questionable or not completely understood. Full disclosure, or reporting as much information as is known at the time, is crucial so the participant can make an informed decision as to whether to participate.

Full disclosure:Reporting as much information about the research as is known at the time without threatening the validity of the study. This practice allows the subject to make an informed decision as to whether to participate.

Some participants may not be informed of some aspects of the research because having such knowledge would likely impair the validity of the research. This threat to validity—called the Hawthorne effect, treatment effects, or placebo effect—may lead subjects to behave differently simply because they are being treated. Such an outcome might happen in a study involving experimental drugs or complementary therapies, for example. Balancing the expectations of participants for the care they will receive with the purpose of the research may be challenging. This issue is most often addressed by using vague, rather than deceptive, language. However, incomplete disclosure is generally allowable only when all of the following conditions are met:

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1. No other nondeceptive method exists to study the phenomenon of interest.

2. The study will make a substantial contribution to the body of knowledge.

3. The deception is not expected to cause significant harm or emotional distress.

4. Participants are debriefed about the deception as soon as possible (Boynton, Portnoy & Johnson, 2013).

Incomplete disclosure should never be used to enroll participants in a study or to elicit cooperation and participation from reluctant subjects by masking or minimizing potential risks.

Comprehension Because a person’s informed consent to participate is based on his or her understanding of the benefits and risks, in addition to the overall importance of the area under study, the researcher acts as a communicator and evaluator when ensuring that the prospective subject understands the intent of the study. When developing the informed consent form, the investigator may use institutional boilerplate templates to communicate all necessary information in an organized fashion. It is important to avoid the use of healthcare jargon and technical terms, and instead to use simple language. For participants from a general population (for example, hospitalized patients), the wording of the consent form should be at a seventh- or eighth-grade reading level. Readability formulas, based on length of sentences and number of syllables per word, can be found in Microsoft Word, or reading level can be calculated directly with any number of free, Internet-based instruments.

Case in Point: Jesse Gelsinger Gene therapy is viewed as having the potential to produce highly impressive advances in medical treatment. In 1992, an investigator with an excellent reputation as a genetic researcher founded a company with the intention of commercializing successful gene therapies. Corporate investors contributed millions of dollars to the company. Following the establishment of the business venture, the investigator designed a clinical trial in which a genetically engineered cold virus was used to deliver genes to correct a genetic liver disorder. This virus had been tested in animals, but not yet in humans, prior to the beginning of this trial.

The investigator’s original proposal involved testing the gene therapy on terminally ill newborns, but this plan was rejected by the institutional bioethicist. Following this setback, the investigator modified the proposed research protocol and decided to test the gene therapy on stable patients with the previously identified genetic liver disorder. Institutional approval was provided in 1995, and the trial commenced at

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multiple study sites. In 1999, Jesse Gelsinger, an 18-year-old subject who had the genetic liver disorder, but who was asymptomatic and living a normal life, was enrolled in this gene therapy clinical trial at the University of Pennsylvania.

At the same time, researchers from other study sites began to contact the investigator, expressing concern about the safety of using the cold virus. The trial continued, however, and Gelsinger—the next-to-last patient enrolled in the clinical trial—received a dose that was 300 times the dose received by the first patient. Gelsinger died from a massive immune system response to the gene therapy. The Food and Drug Administration (FDA) immediately shut down all gene therapy research at the University of Pennsylvania. After Gelsinger’s death, 921 adverse events in this and other gene therapy trials were reported to the FDA and to the National Institutes of Health (NIH) (Parascandola, 2004).

Questions Raised by the Death of Jesse Gelsinger

Should high-risk research be conducted on “healthy, stable” persons? Was this particular research protocol ready for human trials? Were the adverse events ignored? Misinterpreted? Apparent only in retrospect? Did a financial conflict of interest (the investigator owned the gene therapy company) bias the researcher’s judgment?

Research Integrity All types of research, but particularly research involving human subjects, should be conducted under strict ethical guidelines. Research integrity involves more than meeting basic ethical principles for the treatment of human subjects. The researcher’s work must demonstrate integrity in all phases of the research process—from design to analysis through reporting and follow-up.

A well-designed study may be ethical by plan but manipulated during implementation. For this reason, most analysis decisions should be made a priori, meaning before data have been collected. Otherwise, it may be possible to manipulate the data to mislead the reader or to selectively report findings that are supportive of the researcher’s point of view. This manipulation of data can be accomplished in statistical analysis by changing the significance level or by making erroneous assumptions to make the results seem more conclusive (Wasserman, 2013). Data in graphs can be manipulated by changing the distance between the values on the axes to make the results appear more significant than they are. FIGURE 3.1 demonstrates how the same data may be presented two different ways to mislead the reader. In these examples, the vertical axis has been altered to

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make it appear as if one hospital is making more money when, in fact, the hospitals have identical revenue figures.

A priori: Conceived or formulated before an investigation.

FIGURE 3.1 The Two Hospitals Actually Have Equal Revenues

Completing a training course in research protocols is one of the best ways to ensure that research is conducted under the most ethical guidelines. The NIH requires ethics training for anyone involved with NIH grants or anyone who conducts research in NIH facilities. The areas typically covered in this type of training include data acquisition and management, publication practices, research misconduct, and responsible authorship, among others. Those new to the research process should participate in some type of training on the responsible conduct of research, whether or not the study is federally sponsored.

Legal and Regulatory Guidelines for Conducting Research Ethics and law are intimately intertwined; in fact, they might be considered different points on the same continuum. Obeying the law (the minimum standard) is at one end of the continuum, and acting ethically (above the expected minimum behavior) is at the opposite end. This duality of law and ethics also exists in research. The nurse researcher can think of the law as a minimum standard and ethics as a higher standard. Law can also be thought of as a means of conflict resolution. Although most people do the right thing ethically, if they do not, the law is there to resolve the situation. The good researcher maximizes both the legal and ethical protections afforded to subjects in a study.

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Brief Overview of Laws Related to Research The four sources of law that may affect researchers are common law, administrative law, statutory law, and tort law. Common law is derived from judicial decisions made during a trial (case law) and often applies rules from early English common law. Medical malpractice lawsuits are an example of common law. Administrative law is formulated by the federal and state governments and other regulatory agencies and obtains its authority from Congress. An example of administrative law is the Health Insurance Portability and Accountability Act (HIPAA), which is a federal regulation governing the patient’s right to privacy and confidentiality. HIPAA has had dramatic effects on data collection for research purposes, and its implications extend to cutting- edge research methods involving social media, the Internet, and “Big Data” resources. Most laws that affect the clinical researcher are statutes or statutory laws. Statutory laws are enacted, amended, and repealed by the legislature.

GRAY MATTER Four categories of law:

Common Administrative Statutory Tort

A fourth category of legal issues has its roots in tort law. Torts are civil wrongs committed against individuals or their property. Examples of tort law include negligence, malpractice, assault, battery, false imprisonment, invasion of privacy, and causing mental or emotional distress. Although these last allegations are unlikely in a clinical research project, they can happen and may subsequently provoke a malpractice claim. Most claims are brought when a subject believes he or she has been harmed due to negligence on the part of the researcher. Examples of negligence in clinical research include using an instrument known to be defective, using equipment that is not functioning properly, denying a patient reasonable treatment so as to obtain a control group, or not following a specified research protocol so that a patient’s safety is compromised. All of these circumstances may cause injury to the participant and result in a claim of negligence. Under federal regulations, no informed consent form can include language through which the subject waives or even appears to waive any legal rights. In other words, obtaining informed consent from a study participant does not release the investigator from liability for negligence (U.S. Department of Health and Human Services, CFR 45, Part 46.116).

A researcher could also be accused of defamation (a false and harmful oral statement) or libel (a false and harmful published statement) as a result of the

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way he or she presents information in the written account of the research. Truthful researchers need not fear either of these outcomes; both require the intent to distribute information that is known to be incorrect. Reporting the truth is the best defense against accusations of defamation and libel. To further protect the legal rights of subjects, the researcher should guard against referring to individuals’ identity in any written research reports.

The researcher must also guard against inflicting mental or emotional distress. In a research design that involves sensitive topics, the participant may experience painful emotions such as grief, despair, or shame. Most research protocols, therefore, include in the consent form statements such as “potential emotional distress may occur as a result of this research” so that the subject may make a fully informed decision about participation.

A new source of legal issues is the challenge of determining individuals’ rights to their cells as property—a problem that arises when tissue is used to develop cell lines that may potentially be sold for millions of dollars. The global expansion of biobanks of human tissue has raised a wide range of bioethical concerns related to consent, privacy, control, ownership, and disclosure issues (Nisbet & Fahy, 2013). In large part, the debate focuses on whether tissue is the tissue donor’s property, and whether researchers need to obtain informed consent to use tissue from a living donor in research. Other concerns relate to the welfare of vulnerable study participants, oversight of such programs, and donor compensation.

The right to the tissues stored in biobanks is not a clear-cut question of ownership. From a legal standpoint, tissues removed for therapeutic or diagnostic purposes are considered “abandoned,” and their use for research purposes does not require consent. Patients may not even be aware they have contributed their cells to research. Generic consent forms signed during medical procedures often grant practitioners the right to dispose of tissues as they see fit, which may include donating the tissues for research. In case of tissue sample donation, if donors have consented to those samples’ use in research and no longer possess the tissues, they have transferred the right of ownership, including the right to obtain compensation or share in profits from the tissues’ subsequent sale (Moore & McSherry, 2013). The debate continues as to the ethical implications of such a transaction, particularly when the researcher stands to gain financially from the research.

The right of privacy is the right to be left alone. Patients and research participants have a right to the confidentiality of their health records and the release of that information only to those parties whom they have authorized. The right to privacy covers the right both to physical privacy of the person’s body and to the privacy of one’s health information.

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Right of privacy: A person’s right to have his or her health information kept confidential and released only to authorized individuals and to have his or her body shielded from public view.

Privacy is also about human dignity and the privacy of one’s own person. Accusations of invasion of privacy have been brought against personnel for uncovering patients’ bodies unnecessarily or performing examinations in front of others. This practice may be particularly problematic when the research protocol calls for multiple data collectors to check interrater reliability.

Invasion of privacy may also involve the written word. Patients have a right to privacy of their health information throughout the research process, whether they disclose such information verbally or it is retrieved from an electronic or written record. In the field of clinical research, breaches of this right invoke HIPAA sanctions. In cases of breaches of confidentiality or invasion of privacy, the patient or participant need not prove damages, making it easier for the patient or subject to initiate a lawsuit.

To avoid accusations of discrimination in the population under study, researchers must be careful when choosing the populations to exclude from the research. Valid reasons to exclude a particular population, such as pregnant women, members of certain age groups, or patients with certain diagnoses, must be specifically documented. These exclusion criteria are necessary both for good design and to ensure that subjects are selected without bias. Proper selection of the research population is a primary consideration when researchers are studying potentially life-saving treatments.

The key to avoiding any of these accusations is the accurate documentation of all research steps in addition to following the ethical principles discussed earlier in this chapter. Following these guidelines will minimize the threat of any legal action by a research participant and reassure the researcher that he or she is doing the right thing.

Legal Issues Surrounding Informed Consent Signing a consent form to participate in research has the same purpose and carries the same value as does signing the consent form for treatment in healthcare facilities. Requirements governing what should be included in an informed consent form are the same for legal purposes and for ethical purposes. However, legal issues have been raised about who can provide consent for participation in a research study. If the individual cannot legally consent to participate in the research (for example, if the individual is a minor, has been judged incompetent, or is a member of a vulnerable population), the researcher must ensure that the person’s interests are protected. Consent must be obtained from the subject, if possible, as well as from the legal guardian. In some cases, formal consent is obtained from the legal guardian,

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and simultaneously assent is provided by the participant. For example, a child should agree that he or she is willing to participate in a study (assent) even though the legal consent is required from the parents.

If the research involves human subject participation, in addition to consent, the researcher should obtain an authorization that allows the researcher access to the participant’s medical information. This authorization for access to medical information may be incorporated into the consent form. Table 3.4 provides an example of an authorization for release of information.

Table 3.4 Participant Authorization for Release of Information

Full Name:__________ Record Identifier:__________

Date of Birth:__________

Address:__________

City, State, Zip Code:__________

Other Contact Information:__________

Select One Option Below:

1.___I authorize the following person(s) or agencies access to my personal health information for a period not to exceed 90 days from the date of signature below.

2.___I decline authorization for any and all requests for release of my personal health information.

________________________ ________________________

Patient/Participant/Date Researcher/Agency/Date

Emerging Issues: Ethical Use of Social Media Increasingly, health researchers are using personal communication devices and social media to facilitate communication with potential research participants and to gather data. Social media, like any method that blurs the line between the public and private spheres, could qualify as an ethically risky research space (Nind, Wiles, Bengry-Howell, & Crow, 2012). The principles that apply to human subjects in face-to- face research should likewise be applied to the use of any intermediary technology used in a study, such as the Internet. Specifically, the researcher should clearly demonstrate the ethical principles of respect, integrity, and beneficence when utilizing such means of communication.

To date, a few guidelines for the use of social media in research have emerged, but no standard set of rules has been adopted as yet by any research oversight group. Respect in this setting can be demonstrated by letting the subject control the interaction with the researcher.

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Integrity can be maintained by focusing on the privacy of the subject while being cognizant of the potential for personal information to be taken out of context. To prevent this possibility, a specific research project page should be created, and subjects should be allowed to control which data are uploaded. When the study’s project page is linked to an individual’s social media page, the public should be unable to determine which data are being used for the research. Using a specific project page can also protect participants against the public exposure of their identities. To practice beneficence, the researcher should be proficient in the functions of the social media being used, particularly the privacy settings. The consent to participate should include specific language that differentiates between materials that can be submitted privately and those that may be revealed publicly—for example, a private message versus a public post (Lunnay, Borlagdan, McNaughton & Ward, 2015).

Institutional Review Boards Research that involves human subjects in some way—as opposed to retrieving data from records or databases—requires a higher level of oversight. This oversight is provided by legal entities that also are charged with maintaining ethical standards in research. These entities, called institutional review boards (IRBs), are required by law in any organization that allows the conduct of research involving people.

Institutional review board (IRB):The board required in research institutions that reviews and oversees all research involving human subjects and ensures studies meet all federal regulation criteria, including ethical standards.

The roots of IRBs can be traced back to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was established in 1974. This commission advised the U.S. Department of Health and Human Services on policies related to research. It was also instrumental in the adoption of the recommendations of the Belmont Report of 1978.

The U.S. Department of Health and Human Services, acting on these recommendations, developed new regulations governing research and human subjects of research under the Code of Federal Regulations (CFR). These new regulations called for the creation of IRBs, also known as human subjects committees, as safeguards against the inhumane treatment of individuals that had, in the past, been inflicted in the name of science. Part 46 of CFR 45 requires that any research conducted on human subjects be approved by an IRB. According to requirements in Part 46, the mission of the IRB is “to ensure

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that research is ethically acceptable and that the welfare and rights of research participants are protected.”

Case in Point: Nicole Wan Nicole Wan was a 19-year-old sophomore pre-med student at the University of Rochester in 1996 when she volunteered for a study on the effects of environmental air quality. This pollution research project was funded by a Massachusetts Institute of Technology (MIT) grant from the National Institute of Environmental Health Sciences (NIEHS). Wan was one of 200 participants enrolled in an arm of the study at the University of Rochester Medical Center. Participants were paid $150 to undergo a bronchoscopy to examine and collect lung cells.

A medical resident, who was functioning in the role of investigator, administered aerosolized lidocaine, a local anesthetic, to prevent Wan from gagging and to allow for easier passage of the bronchoscope into the patient’s lower airway. Because Wan had discomfort during placement of the bronchoscope, additional lidocaine spray was administered. After completion of the study protocol, she left the medical center and went to a friend’s apartment, where she suffered a cardiac arrest 3 hours later. Although Wan was resuscitated by emergency personnel and admitted to an intensive care unit (ICU) at the medical center, she suffered irreversible pulmonary and neurological damage and died 2 days later. The county medical examiner ruled Wan’s death to be an accident due to acute lung toxicity. On autopsy, her serum levels of lidocaine were found to be four times the maximum levels (McGuire, 1996).

Questions Raised by the Death of Nicole Wan

Is participation in a clinical trial appropriate for a 19-year-old college student? Should parents be notified when students enroll in such studies? What is the “age of reason” for participation in a clinical trial that may carry risk? Why did a medical resident, rather than the principal investigator, administer the study protocol?

The Review Process Research studies that involve human subjects must be reviewed by the IRB. The IRB helps the researcher determine whether there is a potential for a legal or ethical breach and ensures that safeguards are in place to avoid this risk.

There are three categories of research review by an IRB:

Exempt review

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Expedited review Full review

An exempt review covers proposals that do not require review by the IRB. (The IRB determines whether a study is exempt; this is not the researcher’s decision.) This category is limited to studies that pose no risk for the subjects. Such a designation is common when the researcher employs surveys, noninvasive procedures, secondary data or documents, or other methods where it would be impossible to identify any research subject individually. The exemption only refers to the fact that the IRB does not need to review the study proposal; it does not exempt the researcher from the same ethical principles that govern all research.

Exempt review:A review of study proposals that pose no risk to subjects; the full IRB is not required to participate.

An expedited review is used for research that poses only minimal risk to the participants or for those studies that use drugs that do not require FDA approval. Minimal risk means that the probability or magnitude of discomfort anticipated in the research is not greater than what is ordinarily encountered in daily life. It may also be considered no more risky than what would be encountered during the performance of routine physical or psychological examinations or tests. Expedited review research studies are usually reviewed by one or two members of the IRB, who may consult with other board members as necessary.

Expedited review: A review of study proposals that pose minimal risk to subjects; one or two IRB members participate.

A full review is necessary for all research that poses more than minimal risk to the subjects and for research that does not qualify for exempt status. These studies are reviewed by the full committee, with particular attention being paid to the methods, consent process, and selection of the subjects. Studies that require direct access to participants, use personally identifiable medical information, and involve more than minimal risk are subject to full review by the committee. Additional review by a privacy board may be required if personal health information (PHI) is needed for the study. This committee may or may not be part of an IRB and will determine whether patient authorization is required, whether a disclosure notice is required, or whether a waiver can be issued to the researcher that exempts him or her from the consent process. A waiver means the research can be conducted using the methods described in the research protocol and that patient authorizations and disclosures documenting record access are not required. Disclosure forms are discussed in more detail later in this chapter.

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Full review: A review of study proposals that pose more than minimal risk to subjects, that do not qualify for exempt status, and in which the full IRB committee participates.

Researchers should not make assumptions based on these descriptions that their research may be exempt or expedited. No aspect of a study should commence without approval from the appropriate committee or review board. It is the IRB that tells the researcher whether a study is exempt or qualifies for expedited review—not the other way around.

GRAY MATTER Full IRB review must be done under the following conditions:

Studies require direct access to participants. Human subjects are put at more than minimal risk. Protected health information is required. Federal funds are received. Publication is anticipated.

Quality improvement studies are exempt from IRB review. Such studies are typically conducted for the purpose of internal organizational improvement, and there is no expectation of publication or generalization of the results to larger groups. Occasionally, though, quality improvement may be conducted with the idea of publishing a report on the study; in such a case, IRB oversight is appropriate. FIGURE 3.2 lists a set of questions that can help a study designer determine whether a proposed project is solely focused on quality improvement—and therefore requires no IRB oversight—or whether it constitutes research.

When preparing the IRB/Human Subjects Approval Form, the researcher must clearly describe the following eight required elements (CFR 45, Part 46):

1. The research project, the subjects, and how they will be selected and informed

2. The methods and procedures to be used; the subjects should understand their level of participation, what is required, and for how long

3. Risks to the participants, particularly if drugs or treatments are used 4. Benefits to participants 5. How confidentiality and anonymity will be maintained 6. Contact information for questions of participants 7. Explanation of any compensation 8. Statement about voluntary participation

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The IRB is more than a safety net for subjects; it also has the capacity to advise, mentor, and develop new researchers. A tremendous amount of research expertise is available to the researcher via the members of the IRB. Consulting with them early and often in a study can help strengthen the study design. Although much is made of the regulatory authority of the IRB, just as much can be said for its capacity to provide an additional critical evaluation of the research as it is designed. The IRB serves as another safeguard to help the researcher design a strong, ethical, and legal research study. Doing the right thing from the beginning of a study is the best way to avoid legal and ethical accusations.

FIGURE 3.2 Checklist to Differentiate Research from Quality Improvement Studies Used with permission of University of Colorado Health. North IRB, Fort Collins, CO 80526.

Case in Point: Ellen Roche In April 2001, Ellen Roche, a healthy 24-year-old laboratory employee at Johns Hopkins Asthma and Allergy Center, was recruited as a normal volunteer to participate in an NIH-funded research study at her workplace. The aim of this study was to determine factors leading to

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airway irritation in asthma patients. The protocol required the use of inhaled hexamethonium to induce asthma-like effects. The pulmonary toxicity associated with oral, intramuscular, or subcutaneous hexamethonium administration for hypertension was first reported in 1953. Between that time and 1960, 11 articles that included individual case reports and a small series of autopsied cases were published. In 1970, a review article on the use of hexamethonium listed six references from the 1950s.

Johns Hopkins used a stronger concentration of hexamethonium than that cited in the case reports from the 1950s and 1960s. The first volunteer developed a cough; the second volunteer experienced no ill effects. Roche, the third volunteer, developed irreversible lung damage after receiving 1 gram of hexamethonium by inhalation, and died approximately 1 month later. Even as Roche was being treated in the ICU, the trial continued, with six additional volunteers being enrolled. However, none of these six volunteers reached the point in the protocol when hexamethonium would be inhaled. The study was stopped when Roche died.

Later, it was found that this specific study had not been part of the original grant application to NIH, but was mentioned as a planned study in continuation applications. A representative from NIH stated that the hexamethonium study was felt to be consistent with the original goals of the funded primary study and, therefore, was not otherwise scientifically reviewed (Becker & Levy, 2001).

Questions Raised by the Death of Ellen Roche

Did the investigators have sufficient experience with the agent? Did the IRB do a thorough review of this study protocol? Was there any coercion involved in enrolling a subject who was an employee of the Asthma and Allergy Center?

Research Involving Animals Research that may benefit humans is often first conducted on animal subjects. The reason for using animals in research is to advance scientific knowledge while confining unknown risks to nonhuman subjects (Horner & Minifie, 2011a). In recent times, however, the use of animals in research studies has become the subject of considerable debate. Those who advocate on behalf of animals’ welfare recognize the value of testing interventions first on animals, but campaign for the humane treatment and care of these subjects. Some who advocate for animal rights go even further, insisting that animal research should be abolished altogether. Both groups base their stance on studies that demonstrate animal sentience (that is, the ability to experience pain in both vertebrate and invertebrate animals) and a philosophical analysis of the moral status of animals (Ferdowsian & Gluck, 2015).

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The NIH’s Office of Laboratory Animal Welfare (2002) stipulates that applications for Public Health Service grants must include procedures designed to ensure that discomfort and injury to animals used in experimentation will be limited to only unavoidable levels. Furthermore, it requires that analgesic, anesthetic, and tranquilizing drugs be used to minimize the pain and discomfort caused by experiments. Research facilities must be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International; alternatively, they may be evaluated by an institutional animal care and use committee (IACUC), a review committee analogous to the IRB for human subjects.

Multiple guidelines exist to guide researchers in the ethical and humane use of animals in research. In essence, these regulations and guidelines hold researchers accountable for the humane care and treatment of animals used in research through the “three R’s”:

Reduce the number of animals used in experiments. Refine experimental procedures to minimize animal pain and suffering. Replace animal subjects with nonanimal alternatives when scientifically feasible (Ibrahim, 2006).

In June of 2013, the NIH announced its decision to significantly reduce the use of chimpanzees in agency-supported biomedical research. It retained fewer than 50 captive chimpanzees for future biomedical research. The number of research studies involving these primates plummeted. In June of 2015 the U.S. Fish and Wildlife Service announced it had classified captive chimpanzees as “endangered.” The ability to conduct research on any endangered species is very difficult, and in November of that year, Dr. Francis Collins, the Director of the NIH, made the decision to send its colony of chimpanzees to a sanctuary equipped to care for them.

Even with this national example, the debate continues as to whether research on animals is sufficiently humane. The research literature identifies the need for evidence-based guidelines for laboratory animal care and treatment, and broad-based education regarding such guidelines’ application is needed. Also needed are studies to determine the relative benefits of animal testing when realistic alternatives are emerging, such as interactive computer simulations, cadavers, and lifelike manikins (Mangan, 2007). Animal experimentation, much like human experimentation, raises concerns about necessity, purpose, design, risks, and benefits, as well as their relation not to whether the subject is human, but whether the subject has the capacity for suffering.

Research Misconduct Obtaining the necessary approvals of the IRB and privacy committee does not guarantee that the researcher is then free from accusations of battery, negligence, or invasion of privacy. It is up to the researcher to carry out the

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research in an ethical, legal, and moral manner and to document the procedures and results accurately.

Research misconduct, as defined by the federal government, includes fabrication, falsification, and plagiarism. Fabrication is the intentional misrepresentation or “making up” of data or results by the researcher. Falsification occurs when the researcher falsifies or manipulates the results, changes the procedures, omits data, or accepts subjects into the study who were not in the original inclusion criteria. This may seem like a rare occur- rence, but in 2015, all 14 incidents of research misconduct documented on the Office of Research Integrity webpage (ORI.hhs.gov/case_summary, retrieved August 17, 2016) by the U.S. Department of Health and Human Services were related to falsifying data, and all cases were serious enough to result in imposed sanctions. Plagiarism usually arises from the written account of the research, when ideas, statements, results, or words are not attributed to the appropriate person but rather are represented as the writer’s own work.

Other sources of research misconduct can involve undisclosed conflicts of interest, misleading authorship, data acquisition and ownership, and duplicate publication practices. Research misconduct affects the cost of research overall by increasing the oversight required and by diminishing the confidence and respect of the public regarding the results of scientific research. The public may begin to grow skeptical of research results if such behaviors become commonplace (Horner & Minifie, 2011b).

The key factor in determining if research misconduct took place is whether the researcher intentionally misrepresented the data. Research misconduct has not occurred if a researcher made honest mistakes. Misconduct also has not occurred if researchers simply have differences of opinion. This is an important distinction. Good researchers take calculated and controlled risks. As long as the researcher takes the time to carefully plan a strong study, gains the approval of the necessary IRB and privacy committees, and maintains inflexible ethical standards during the implementation of the study, the researcher has fulfilled his or her obligation as an accountable steward of the study.

The HIPAA Privacy Rule What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about.

—Hippocratic Oath (Edelstein, 1943)

Since April 14, 2003, the effective date of the U.S. privacy rule, otherwise known as HIPAA, organizations have more tightly scrutinized research

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proposals, especially those that involve the use of patient data and human subjects.

Reacting to the increasing accessibility of electronic data specific to individuals, Congress passed the Health Insurance Portability and Accountability Act (HIPAA) in 1996. Aimed mostly at electronic health record (EHR) initiatives, one of HIPAA’s main elements is a requirement for the protection of PHI. This rule protects all elements considered protected health information—a broad range of information that varies from telephone numbers to diagnoses. Table 3.5 lists the information that is considered identifiable PHI.

Health Insurance Portability and Accountability Act (HIPAA): Legislation passed by Congress in 1996, which protects the privacy of personal health information.

The introduction of HIPAA’s privacy rule resulted in changes from the way healthcare organizations traditionally handled patients and their information. Healthcare workers now are given access to only the PHI that is necessary to perform the assigned work at hand. For example, those personnel working in ancillary departments receive only a diagnosis that enables them to process the tests or bills. Therefore, the researcher cannot automatically assume that access to all the information required to complete research will be provided, even if the researcher is employed by the facility.

Failure to comply with the rule can be very costly to both the researcher and the organization. The privacy rule specifically states that any employee who fails to comply with the privacy policy will be subject to corrective action, termination of employment, and possibly prosecution by the Office of Civil Rights. Heavy fines accompany proven violations of the rule. These potential consequences have given organizations pause when requests for access to PHI are made.

Table 3.5 Identifiable Personal Health Information

Name

Past, present, or future health conditions

Description of health care provided to the patient

Telephone numbers

Fax number

Email address

Social Security number

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Medical record number

Health plan beneficiary number or account number

Past, present, or future payment for provision of health care

Medical device identifier

Internet Protocol (IP) address

Biometric identifiers, including finger and voice print

Full-face photographic images and any comparable image

Any other unique identifying number, characteristic, or code

In turn, researchers must not assume that simply because they work in a healthcare facility, they will have ready access to that facility’s patient data, databases, or diagnostic information or even limited data sets. The provisions of the privacy rule provide additional safeguards for study participants, which can make it difficult, though not impossible, to do research in healthcare facilities. The researcher should determine well in advance of the start of the study as to whether access to certain data elements and health information can be obtained and how.

If the researcher requires access to the medical records of the patient or study participant, signed consent forms should be obtained that authorize the researcher to access the information. The research consent form should include an authorization for access to records. If that provision is not included, the researcher must document how access to the information will be obtained. Retrospective studies that involve the use of patient data from electronic sources or the medical record may require the researcher to supply a disclosure statement to document access. Alternatively, the IRB may grant a waiver that exempts the researcher from obtaining authorization, although disclosure statements may still be required. Table 3.6 provides an example of a disclosure statement.

While healthcare providers concede that sharing health data is crucial for the development of population health programs and public policy, ethical guidelines for the use of data from large clinical data warehouses are unclear. Technological advances have outpaced the ability to develop and gain wide agreement on ethical, legal, and social issues regarding the use of shared PHI and the reuse of data for research. On the one hand, use of data housed in large databases has enabled translational research projects that have been used to improve practice on a grand scale. On the other hand, there are no universal guidelines for transparency, trust, and security (Lamas, Barh, Brown & Jaulent, 2015). The use of information drawn from large data warehouses raises questions about the reuse of data collected for one

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purpose for an entirely different purpose—in this case, research. Some of the issues under debate include patients’ right to information about use of their data and their right to consent, researchers’ agreements for data sharing, rights to access data warehouses in public institutions (e.g., the Medicare program), means to optimize data confidentiality, and considerations of the common good.

Table 3.6 Sample Disclosure Statement for Research Records

Disclosure for Research Purposes

Date:_____________ IRB/Approval #_____________

Patient Name:_____________ Medical Record #_____________

Researcher:__________________________

The above-named patient’s record was accessed by the researcher for purposes of data collection in a research study approved by this organization.

Information used from this record will not disclose any individually identifiable health information and will be kept confidential as described in the research protocol on file with the organization’s research review board.

Reading Research for Evidence-Based Practice Most studies will not explicitly describe the ethical or legal issues they faced unless those issues were unusual or difficult to resolve. This is not a weakness, but rather reflects the reality that ethical and legal compliance are a given when planning any research study. Ethical and regulatory guidelines are not negotiable, so it may be simply stated that the study underwent IRB review. When such a statement is made, it is safe to assume the study was reviewed by an objective panel and met basic ethical and legal requirements.

If explicit reference to the IRB is not made, then the nurse reader will need to scrutinize the methods section to determine whether a breach of ethical or legal requirements might have occurred. Particular attention should be paid to the methods for selecting the sample, obtaining informed consent, assigning subjects to treatment groups, and accessing their medical data. All of these procedures should reflect a fundamental respect for the ethical principles described in this chapter. The reader should be especially concerned if there were significant risks associated with the study, or if data were collected from medical records without a description of how privacy was protected. However, the absence of any mention of procedures to safeguard subjects does not mean these safeguards were not in place.

CHECKLIST FOR EVALUATING THE ETHICAL ISSUES IN A STUDY

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❏ Adequate protections are in place to protect subjects from any potential harm.

❏ The authors document approval from the IRB.

❏ It is clearly indicated that subjects underwent informed consent.

❏ If vulnerable populations were involved, special consideration was given to informed consent and study procedures.

❏ Steps were taken to protect the anonymity, confidentiality, and privacy of subjects.

❏ There was no evidence of any type of coercion (implied or otherwise) to motivate participants to agree to the study.

❏ The researchers provided full disclosure to potential subjects. If deception was necessary to achieve the goals of the study, participants were debriefed about the experience.

❏ The benefits of the study outweighed the risks for individual subjects; a risk/benefit assessment was considered.

❏ Subjects were recruited, selected, and assigned to groups in an equitable way.

Using Research in Nursing Practice The nurse should be hesitant to use the results of research in practice if he or she suspects the study was conducted unethically or in some way breached the legal protections of subjects. The nurse should be aware that research misconduct can occur, and that studies that are the result of such misconduct cannot be trusted. Ethical and legal constraints also help ensure research quality and validity of findings; results that were generated through deception or duress will likely not represent the population well. In other words, if the researcher cannot be trusted, then the research findings cannot be trusted either.

Creating Evidence for Practice The nurse researcher can best deal with the potential ethical and legal issues in a research study by focusing on strong designs that answer the research question with a minimum of disruption in subjects’ lives. If the nurse researcher focuses on doing the right thing, it is rare that an ethical or legal issue will arise.

The researcher must keep in mind, however, that compliance with ethical and regulatory issues is not confined to the design period. Some problems may arise during the implementation of a research study. Adherence to the principles that guide the legal and ethical treatment of subjects—whether in preparation for an IRB review or for actual data collection—should be ongoing

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throughout the study. Inadvertent problems and unforeseen issues may arise during research. The careful researcher considers these fundamental guidelines as a basis for decisions about the entire research process, not just the IRB application.

New ethical challenges may emerge when investigators are conducting research on the Internet. Through this medium, researchers can access subjects worldwide, from settings that are rarely represented in studies. Yet, gathering data on the Internet requires attention to additional ethical standards:

Ensure subjects have a safe, private space to respond. Support the ethical acquisition of web addresses; ensure that the list owner has endorsed the study. Assess the potential risk of harm to participants and the intrusiveness of the study. Evaluate the vulnerability of the subjects. Implement a process to ensure subjects are of legal age to participate (Williams, 2012).

Research contributes knowledge to a field. The public relies on this knowledge to determine future courses of action, whether it is to decide on a course of medical treatment or merely to keep abreast of trends and current data. All research, then, must always be conducted with integrity, honesty, and respect for all parties involved, and with the utmost attention to ethical guidelines and regulatory limits.

Summary of Key Concepts When humans participate as subjects in research studies, care must be taken to preserve their rights. Subjects have the right to be informed of the study processes and potential risks, to be treated in a fair manner, and to withdraw from the study at any time. The Nuremberg Code and the Declaration of Helsinki are international guidelines for the conduct of ethical research; the United States also has the Belmont Report to guide researchers’ behavior. Therapeutic research, in which the subject can be expected to receive a potentially beneficial treatment, differs from nontherapeutic research, which contributes to the body of knowledge but not to an individual’s health. The foundational ethical principles that guide researchers in the treatment of human subjects are respect for persons, beneficence, and justice. The basic values that guide the research process include truthfulness, trust, and the best interests of the participants. Vulnerable populations include those groups with limited autonomy or capacity to make decisions. These populations are subject to special protections to ensure they are not exploited in research.

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Informed consent is a process of information exchange that begins with subject recruitment. Full disclosure of risks and benefits and the provision of understandable information needed to make a participation decision are hallmarks of a strong informed consent process. Deception or incomplete disclosure should be avoided in research. When it is necessary, there should be a strong rationale and subjects must be fully debriefed after the experience. Informed consent documents should be prepared in the most comprehensible way possible so that subjects are fully aware of the particulars of the study. Research integrity extends beyond subject rights to the way data are collected, analyzed, and reported. The nurse researcher advocates for the participants in research studies and must protect their autonomy and confidentiality at all times. IRB requirements have their origin in federal regulations and require varying levels of involvement in the approval process, depending on whether they involve expedited, exempt, or full board review. The IRB was established in response to the inhumane treatment of subjects, and the protection of individuals who are asked to participate in research remains the IRB’s primary concern. The IRB is also a helpful group in providing critical feedback that can improve the design and strength of a study. Animal experimentation, much like human experimentation, raises concerns about necessity, purpose, design, risks, and benefits. Guidelines in this area focus on reducing the number of animals used in experiments, refining experimental procedures to minimize animal pain and suffering, and replacing animal subjects with nonanimal alternatives when scientifically feasible. HIPAA provides another layer of protection by guaranteeing the subject’s right to protection of PHI. The researcher must plan carefully to ensure that all legal requirements are met, particularly because violations can carry with them serious consequences.

For More Depth and Detail For a more in-depth look at the concepts in this chapter, try these references:

Anderson, E., & DuBois, J. (2012). IRB decision making with imperfect knowledge: A framework for evidence-based research ethics review. Journal of Law, Medicine, & Ethics, 40(4), 951–969.

Bradford, W., Hurdle, J., LaSalle, B., & Facelli, J. (2013). Development of a HIPAA-compliant environment for translational research data and analytics. Journal of the American Medical Informatics Association, 21, 185–189.

Cseko, G., & Tremaine, W. (2013). The role of the institutional review board in the oversight of the ethical aspects of human studies

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research. Nutrition in Clinical Practice. doi: 10.1177/0884533612474042

Dereli, T., Coskun, Y., Kolker, E., Guner, O., Agirbasli, M., & Ozdemir, V. (2014). Big data and ethics review for health systems research in LMIC’s: Understanding risk, uncertainty, and ignorance—and catching the black swans? American Journal of Bioethics, 14(2), 48–50. Greaney, A., Sheehy, A., Heffernan, C., Murphy, J., Mhaolrúnaigh, S., Heffernan, E., & Brown, G. (2012). Research ethics application: A guide for the novice researcher. British Journal of Nursing, 21(1), 38– 43.

Hudgins, C., Rose, S., Fifield, P., & Arnault, S. (2013). Navigating the legal and ethical foundations of informed consent and confidentiality in integrated primary care. Families, Systems, and Health, 31(1), 9–19.

McKee, R. (2013). Ethical issues in using social media for health and health care research. Health Policy, 110, 298–301.

Milton, C. (2013). The ethics of research. Nursing Science Quarterly, 26(1), 20–23.

Vayena, E., Mastroianni, A., & Kahn, J. (2012). Ethical issues in health research with novel online sources. American Journal of Public Health, 102(12), 2225–2230.

Williams, S. (2012). The ethics of Internet research. Online Journal of Nursing Informatics, 16(2). Retrieved from http://ojni.org/issues/? p=1708

CRITICAL APPRAISAL EXERCISE Retrieve the following full text article from the Cumulative Index to Nursing and Allied Health Literature or similar search database:

DeGrazia, M., Giambanco, D., Hamn, G., Ditzel, A., Tucker, L., & Gauvreau, K. (2015). Prevention of deformational plagiocephaly in hospitalized infants using a new orthotic device. Journal of Obstetric, Gynecologic & Neonatal Nursing, 44(1), 28–41.

Review the article, looking for evidence of any ethical or legal issues that arose in the study and how the researchers dealt with them. Consider the following appraisal questions in your critical review of this research article:

1. In which ways are the subjects in this study vulnerable? Which protections should be put in place to protect these subjects from

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harm? 2. Identify the potential risks inherent in this study for the subjects.

What should specifically be included in the informed consent for this study?

3. What evidence is provided by the authors that the study was reviewed by the IRB and that appropriate informed consent was obtained?

4. How do the authors minimize the risks to the subjects? 5. In your opinion, do the potential benefits of this treatment

outweigh the potential risks to the infant? Why or why not?

References Becker, K., & Levy, M. (2001). Ensuring patient safety in clinical

trials for treatment of acute stroke. Journal of the American Medical Association, 286(21), 2718–2719.

Boynton, M., Portnoy, D., & Johnson, B. (2013). Exploring the ethics and psychological impact of deception in psychological research. IRB: Ethics & Human Research, 18(2), 7–13.

Centers for Disease Control and Prevention. (2011). U.S. Public Health Service syphilis study at Tuskegee. Retrieved from http://www.cdc.gov/tuskegee/timeline.htm

Edelstein, L. (Trans.). (1943). The Hippocratic oath: Text, translation and interpretation. Baltimore, MD: Johns Hopkins University Press.

Ferdowsian, H., & Gluck, J. (2015). The ethical challenges of animal research. Cambridge Quarterly of Healthcare Ethics, 24, 391–406.

Franklin, P., Rowland, E., Fox, R., & Nicolson, P. (2012). Research ethics in accessing hospital staff and securing informed consent. Qualitative Health Research, 22(12), 1727–1738.

Hardicre, J. (2014). An overview of research ethics and learning from the past. British Journal of Nursing, 23(9),

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483–486.

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Part II: Planning for Research 4 Finding Problems and Writing Questions 5 The Successful Literature Review 6 Selecting an Appropriate Research Design

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Chapter 4: Finding Problems and Writing Questions

CHAPTER OBJECTIVES The study of this chapter will help the learner to

Discuss strategies for identifying evidence-based practice problems. Describe the process for translating a practice problem into a researchable question. Define and contrast problem statements and purpose statements. Develop and articulate problem statements and purpose statements. Perform a critical analysis of the question, problem statement, and purpose statement from a research article.

KEY TERMS Concepts

Deductive

Directional hypothesis

Hypothesis

Inductive

Nondirectional hypothesis

Null hypothesis

Problem statements

Purpose statements

Replication study

Research question

Introduction The best research starts with two words: “I wonder.” A sense of curiosity is all that is needed to begin the research process. Observations about a practice problem become questions, and these questions lead to nursing research that provides evidence to solve the problem.

Finding and developing significant problems for nursing research is critical to improving outcomes for patients, nurses, organizations, and communities. The

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evolution of a research problem from a general topic of interest to the articulation of problem and purpose statements serves to narrow the focus to a researchable question. This progression moves the research problem from the conceptual (abstract concepts) to the operational (measurable concepts or variables). FIGURE 4.1 depicts how the individual steps in translating a problem into a researchable question follow this path.

FIGURE 4.1 Traditional Evolution of the Research Process

VOICES FROM THE FIELD The idea for this research study actually had its beginnings in a class on critically reading research that I took. I work on a medical–surgical unit, and my team decided that we would like to try to do a small project. We decided to do some observation and find a question to study, even though it is a really busy unit.

About that time, we had a physician who began doing more bariatric surgery. The standing orders for these patients were to have physical and occupational therapy personnel evaluate the patients and get them up and walking. We had always interpreted that order as being implemented on the next morning, because the therapists were

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generally not available in the evenings when these patients were in shape to start moving. We had patients who wanted to get up and start walking the first evening, though, so we would help them walk. We noticed that these patients seemed to get less nausea. Limiting nausea and retching is important in these patients because we cannot get their intravenous line (IV) out until they are not vomiting, and retching is very painful for them. They get their pain medications through the IV, and if they are vomiting we cannot switch to oral medications and pull their IV lines. If the patients had to wait until the second day to walk, it seemed they had more nausea and vomiting, and those reactions just backlogged everything. It usually meant that their discharge was delayed until the evening of the second day. We wondered if perhaps the earlier walking was helping with the nausea.

We started with a literature search. Originally, we planned to find a study and replicate it; we never thought we could do a study of our own. We just wanted to duplicate what someone else had done. But there were no studies to be found. We found lots of studies of the effects of ambulation in the postoperative period, but nothing dealing with this specific group of patients, and none of the studies measured nausea as the outcome measure. So we thought, “Maybe we need to do a study.” We were going to do something very simple—not even go through the institutional review board (IRB), but instead undertake an investigation that was more like a quality study. We were nervous about having to go to the IRB; we thought that would be far too deep for us. We thought a little study would be a good way—a really simple way—for the staff to become involved in research, and we thought it was doable.

We had an opportunity to consult a researcher through our evidence- based practice council. The researcher told us, “This is a good study; this is publishable,” and that was a turning point for us. We realized that this topic was as important as what other nurse researchers studied, and we recognized that we had an opportunity to make a contribution to practice.

What started as a simple little question—Does walking affect nausea? —has evolved into something more complicated. Our research question is now based on time—in other words, how soon does the patient have to walk to get a benefit? The process forced us to produce criteria for when a patient is ready to walk, which became a conversation in which the whole staff participated. We introduced another element after consulting with physical therapy personnel. We now have one group in which patients use a bedside pedaler and a second group in which patients walk, and we will see if one approach offers an advantage. That would be helpful to know, because when we have really chaotic days, we may not have a lot of time to stop and help someone walk. If we find that the pedaler does help the patient’s gut “wake up” faster,

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then we can use this device instead of providing walking assistance, because it takes much less time.

When the people on the unit realized that our goal was publication, they got on board with our research. We have learned to appreciate the nurses with whom we work who have stayed in medical– surgical nursing. One of the driving forces behind this effort was our quest to gain some respect for the fact that we are a highly qualified group of nurses who care deeply about patient care and doing the right thing for patients. Taking our nursing practice to the next level through publication of original research could be a real source of pride for the staff—and we think that is why they are so solidly behind it.

Our study has encouraged us to look at our whole nursing practice and realize it is not insignificant—that our research is something someone would want to read. Now that we have finished the IRB process, we have realized, yeah, we really can do that.

Maureen Wenzel, FNP-BC

The traditional method for finding and developing research problems suggests a deductive, sequential process moving from a general interest to the development of a research question. FIGURE 4.2 illustrates how the individual steps might look in the development of a specific researchable question.

Deductive: A process of reasoning from the general to the specific.

In truth, the process of finding and developing research problems can be as chaotic as a busy parking lot. Some motorists drive their cars headfirst into the spaces, some motorists back their cars into the spaces, and still other motorists drive their cars into and out of the spaces until their cars are properly positioned. Research question development likewise is amenable to many different approaches. Some researchers do, indeed, use a sequential set of steps to arrive at a specific and well-articulated question. Many other nurse researchers use nontraditional methods for finding and developing research problems. These processes may be more inductive, in which specific observations serve as the starting points, leading to a general focus or interest. This approach is more common in evidence-based practice studies, as specific problems generally spark interest in finding an overall solution via research. FIGURE 4.3 demonstrates a nontraditional example of finding and developing a research problem. Still other methods may begin somewhere in the middle of the traditional process by recognizing a gap, then proceed to identify the big picture as well as the specific research question.

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FIGURE 4.2 Example of a Traditional Evolution of the Problem

Inductive: A process of reasoning from specific observations to broader generalizations.

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FIGURE 4.3 Nontraditional Example of the Evolution of a Research Problem

Regardless of the approach—deductive, inductive, or somewhere in between — finding and developing research problems may be a process best characterized as a work in progress. The goal is always the same, though: to narrow the focus of the research problem so that a feasible research question emerges. The importance of narrowing the focus of the research cannot be overstressed. Research problems that have not been narrowed generate too many concepts and relationships to test.

Concepts: Abstract ideas or topics of interest that must be narrowed to researchable questions to be investigated.

The initial phase of implementing evidence-based practice is identifying the need for change that will improve patient care (Facchiano, Snyder & Nunez, 2011). The need for change may become evident to nurses because of emerging problems or new knowledge (Boswell & Cannon, 2012). During this phase, the topic is selected and preliminary, problem-based questions are considered. Key words in problem-based questions drive the search and retrieval of literature and set the stage for research design. This narrowing

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process is used both in the research process and in evidence-based practice (Boswell & Cannon, 2012).

Subjects or topics that are overly broad are problematic for researchers because they mean that methodological complexities increase, expert methodologists are required, and resource demands (for example, money, people, and time) increase. With every additional concept or associated relationship examined, the feasibility of the study may be affected.

The primary objective of nursing research is to increase knowledge so as to improve nursing practice, but, of course, it can be accomplished only if the research is actually completed. Some researchers spend a lifetime studying a single concept; others spend their careers completing multiple, small studies. There is no shame in starting, or staying, small. Narrow questions are far easier for the novice researcher to address and may help the nurse learn skills that can then be applied to larger, more complex studies.

As the research problem moves from a broad topic of interest to a narrower, researchable question, measurable variables and outcomes should become evident. It is helpful to consider the type of concept under investigation when approaching this determination. Concepts may represent many things, but they generally fall into three categories: patient sensitive, staff member sensitive, or organizationally sensitive. Concepts studied by nurses, especially novice nurse researchers, should be limited to those within the nursing span of control. For example, a nurse interested in the development and severity of hematomas at arterial access sites after diagnostic or interventional arteriography would be better suited to asking research questions about positioning and turning the patient, rather than addressing questions about the method of arterial access used for the procedure. The first research question identifies nurse-sensitive concepts (repositioning and turning), whereas the second research question identifies medically sensitive concepts (arterial access methods). Table 4.1 provides examples of each of these kinds of concepts.

GRAY MATTER Nursing research concepts can be organized into three categories:

Patient sensitive Staff member sensitive Organizationally sensitive

Finding and Developing Research Problems Often, research problems find the nurse, rather than the other way around. Frustrations with ineffective procedures, the search for a “better way,” or the need to help a single patient may motivate the nurse to seek research-based

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evidence to improve patient care. The search for research problems is one of the easiest parts of the research process; researchable problems surround the contemporary nurse in practice.

Sources of Research Problems Researchable problems can come from an almost unlimited number of sources (American Association of Colleges of Nursing [AACN], 2013; Boswell & Cannon, 2012; Schmidt & Brown, 2011). The following are some sources for researchable problems:

Clinical practice observations Educational processes and experiences Consumer/customer feedback and personal experience Theoretical models and frameworks Professional literature Performance improvement studies Research reports and priorities Social issues

Clinical Practice Research problems may be generated from active, passive, or other organizational activities. Active methods of problem discovery include experiences with direct patient care and discussion with other members of the healthcare team through formal or informal communications. Patient problems, ineffective clinical procedures, and changes in protocols all present opportunities for research. Passive methods for identifying problems include medical record review and observation. Data collection activities, such as those performed for quality improvement or risk management purposes, may also bring problems to light.

Table 4.1 Examples of Patient-, Nursing-, and Organizationally Sensitive Concepts

Patient-Sensitive Concepts

Nurse-Sensitive Concepts

Organizationally Sensitive Concepts

Anxiety Burnout Cost

Skin integrity Lower back injuries Length of stay

Functional independence Medication errors Readmission

Blood glucose Pain management Resource utilization

Blood pressure Patient falls Satisfaction with nursing care

Quality of life Restraint prevalence Satisfaction with nursing care

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The need for confirmed evidence-based practice generates numerous research questions. Nurses are in a unique position to change and confirm clinical practices. Through structured decision-making processes, nurses, other members of the healthcare team, and patients and families together have the ability to improve healthcare-related processes, outcomes, safety, satisfaction, and costs (Boswell & Cannon, 2012). Nursing practice comprises a mixture of evidence and tradition. It is essential that nurses continually ask themselves and one another the crucial questions: What is the evidence for this approach to nursing care? Can I solve this problem with evidence?

Educational Processes and Experiences Nursing students who are taking research courses are required to develop problem, purpose, and research statements from required and/or self- determined topics. Research-focused educational institutions may also support institution-driven research activities examining interests such as age- specific care, the effects of caring, or nursing shortage outcomes. Within the assignments and disciplined inquiry that occur during the educational experience, particularly graduate study, nursing students and their mentors may generate many researchable problems.

Consumer Feedback or Personal Experience Research problems may be generated from consumer or personal experience. Such problems are distinguished from social issues; that is, consumers of health care have the opportunity to share ideas about and perceptions of care and treatment, and to suggest research questions that can potentially promote health throughout the continuum of care, improve patient outcomes and safety, and influence delivery models and cost-effectiveness (Centers for Medicare & Medicaid Services [CMS], 2013; Hospital Care Quality Information from the Consumer Perspective [HCAHPS], 2013; Patient- Centered Outcomes Research Institute [PCORI], 2013). Nurses may also have experiences as family members or as patients themselves. This unique perspective, in which nurses view nursing care from the other side of the bed, gives rise to opportunities to transform that care. Research problems generated from personal experience may expose clinical, consumer, social, and other opportunities for improvement and drive the research priorities of both individuals and organizations.

Research problems generated from the results of activities aimed at soliciting consumer and/or patient feedback may be generated from the following sources:

Patients and customers of the institution, both external and internal Leaders who represent the interests of specific services (e.g., cardiac care) Departments (e.g., coronary care unit) and service lines (e.g., cardiac services) within an organizational structure

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Members of general or specialty professional organizations (e.g., American Nurses Association, American Association of Critical-Care Nurses) Advisory boards and other consumer/customer input organizations Accrediting, regulatory, and safety organizations

The feedback garnered from these groups may be used to generate problem statements, purpose statements, research questions, and testable hypotheses, as well as to set priorities for performance improvement or other research activities. Feedback may be solicited through surveys, during formal and informal meetings, and at conferences and workshops, or it may be received electronically.

Professional Literature Research problems may be generated from the results of professional literature reviews. Sources of professional literature reviews include clinical and nonclinical works, databases, and letters and opinions. Clinical works include books and journals addressing nursing and medical topics, both general and specialty. Nonclinical works include books and journals presenting non-nursing and nonmedical topics from other fields of study that may be generalized into an appropriate, researchable problem to expand nursing knowledge. Many databases, both clinical and nonclinical, are capable of provoking inquiry. Examples of these databases include those that hold data from previous studies (clinical) and census data (nonclinical). Many research problems have been developed by using the data collected by other researchers and taking a unique approach to the analysis.

Published letters and opinions are another interesting source of research problems. Letters and opinions written by nurses and other medical professionals often express concern, as well as issue directives, about researchable problems, gaps in current knowledge, limitations of available research, and recommendations for future research.

Performance Improvement Activities Performance improvement activities, also known as quality improvement activities, are used to improve processes and outcomes and to meet regulatory requirements. Tools and techniques specific to performance improvement activities do not meet the requirements of traditional research methods. In particular, performance improvement studies are often characterized by methodological limitations, a lack of control over extraneous variables, violation of assumptions for statistical testing, and small sample sizes in a single setting; all of these factors affect the generalizability of their findings. Nevertheless, the results of performance improvement activities may be used as a springboard to engage in formal research activities. Researchable problems may start as performance improvement activities and expand into formal research projects with alterations in methodological approach, sampling strategy, and informed consent procedures.

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Research Reports and Priorities Research problems may also be generated from the outcomes of other research studies and evidence-based practice reviews. Previous research may influence the generation of research problems either directly or indirectly. By convention, most research reports include a section on “suggestions for future research,” which outlines ways to extend and expand on the currently available research. Researchers may directly influence the generation of subsequent research problems by explicitly stating remaining problems, gaps, and questions. One means of directly influencing subsequent studies is the type of research known as a replication study. Replication studies may be used to validate findings and knowledge, increase their generalizability (population and setting), or eliminate or minimize limitations (methodology). Replication studies are good exercises because they increase the knowledge of inexperienced researchers. Research also may indirectly influence the generation of a problem when the reader identifies a problem with the written report (e.g., a discrepancy, gap, inconsistency, or unidentified limitation) or disagrees with the methodology and/or results of the original investigator.

Replication study: A study generated from previous research studies in which the research is reproduced to validate findings, increase generalizability, or eliminate or minimize limitations.

The directives and recommendations of individuals and organizations may also serve as a source of research problems. In developing these directives and recommendations, individuals (educators and researchers) and organizations (clinical, educational, funding, and regulatory) apply their expertise to identify problems and gaps in current knowledge. Some of these experts may have developed problem statements and research questions to prioritize future research.

Social Issues Research problems may be generated from social issues. Social issues include, but are not limited to, the effects of age, culture, education, gender, income, race, religion, and sexual preference. Social issues may be examined in the context of current events, the environment, and health policy. They may also be addressed in relation to local, state, national, or international populations. For example, obesity may be considered in terms of age, gender, race, and other social classifications. Notably, the “obesity epidemic” has given rise to equally epidemic rates of diabetes and heart disease. Additionally, obesity and its associated comorbidities affect national issues such as healthcare expenditures (percentage of the gross national product) and the ability of the government to maintain military readiness. Given this condition’s widespread impacts, it should not be surprising that a large number of organizations are examining obesity-related research questions. Collaborative, multidisciplinary studies addressing research questions that are

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clinically and socially relevant and that could potentially improve outcomes in local, national, and international communities are more likely to receive support and to receive funding (White, 2012).

This list of sources for research problems is not exhaustive. Research problems are often the product of both internal and external driving forces; they are seldom generated from a single source. Any process or outcome associated with patient care, staff members’ work environment, or organizational success may become the basis for study. The potential nurse researcher can scrutinize the current practices and ask the following questions:

Why are we doing it this way? Is there a better way of doing it? Should we be doing it at all?

All of these questions may give rise to researchable problems, whose solutions may add valuable evidence to the effective practice of nursing.

Articulation of Research Problem Statements Research problem statements are declarations of disparity: the difference (gap) between what is known and what needs to be known about a topic. They articulate a discrepancy that is to be addressed by the research process. The disparity, whether a small gap or a large chasm, defines the area(s) of concern and focuses the research methods (Boswell & Cannon, 2012; Schmidt & Brown, 2011). Most problem statements are explicitly stated; however, some problem statements may be inferred. The inferred research problem statement may describe the importance or potential consequences of the disparity as it pertains to clinical practice.

Problem statements: Statements of the disparity between what is known and what needs to be known and addressed by the research.

Problem statements, explicitly stated or inferred, are usually found at the beginning of a research report, in the introduction, or in the review of literature, and they may be repeated throughout the written report. The idea of a single problem statement is misleading; problem statements may resemble problem paragraphs and often can be several sentences long. Problem statements may be written as either questions or statements, and well-written ones contain clear, concise, and well-defined components.

Two examples of well-written problem statements from published articles follow:

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“The background research identified eight articles that looked at the gendered experience of being a nurse, six from the male perspective and two from the female, but none comparing these experiences” (Rowlinson, 2013, p. 218). “The majority of studies were quasi-experimental, and all examined disposable infant diapers under conditions of high humidity and/or radiant heat sources. One study found that no significant changes occurred after six hours; all others found that changes in diaper weights occurred. The question remained unanswered as to what changes might occur in diaper weights over time in open-air, open bed patient environments” (Carlisle et al., 2012, p. 224).

Development of Research Purpose Statements Whereas research problem statements identify a gap in knowledge that requires disciplined study, research purpose statements are declarations of intent. Purpose statements indicate the general goal of the study and often describe the direction of inquiry (Boswell & Cannon, 2012; Schmidt & Brown, 2011). The purpose of the research should be clearly stated.

Purpose statements: Declarative and objective statements that indicate the general goal of the study and often describe the direction of the inquiry.

Purpose statements are written as objective statements. They are easily identified in reports by their inclusion of words such as aim, goal, intent, objective, or purpose. They contain clear, concise, and well-defined components including key variables to be studied, possible interrelationships, and the nature of the population of interest.

Two examples of well-written purpose statements from published articles follow:

“The objective was to explore, analyze, and compare and contrast the gender differences with the existing literature” (Rowlinson, 2013, p. 219). “The purpose of this study was to examine changes in disposable infant diaper weights at selected intervals post-wetting” (Carlisle et al., 2012, p. 224).

Researcher bias is a limitation that may cause readers to question the validity of research processes and outcomes. When developing purpose statements, researchers should use unbiased verbs such as compare, describe, develop, discover, explore, test, and understand and avoid biased verbs such as demonstrate, prove, and show.

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Example of using an unbiased verb: The purpose of the study was to explore the effects of music therapy on speech recovery in adult stroke patients in a rehabilitation facility. Example of using a biased verb: The purpose of the study was to prove that music therapy improves speech recovery in adult stroke patients in a rehabilitation facility.

Table 4.2 lists some useful verbs for purpose statements. Carefully writing the purpose statement is the first step in demonstrating the research question’s appropriateness for study. Although a purpose statement is relatively easy to compose, completing a study is a time-intensive, arduous process. It should be undertaken only when the researcher has a reasonable expectation of successfully achieving the purpose as stated.

Fit of the Purpose Statement Research purpose statements indicate how variables will be studied within specific populations and settings. There should be a good fit between the design suggested in the purpose statement and the methods used in the research study (Boswell & Cannon, 2012; Schmidt & Brown, 2011). The following examples demonstrate potential purpose statements for a quantitative, correlation design:

The purpose of the study was to determine the direction and strength of the relationship between depression and functional independence in patients at an urban rehabilitation center. The purpose of the study was to measure the effects of depression on functional independence in patients at an urban rehabilitation center.

The purpose statement in the first example exemplifies a good fit between the purpose statement and the study methods. Correlation methods measure the direction and strength of a relationship; they are not appropriate for assessing cause and effect. The purpose statement in the second example does not have a good fit with this method because it indicates the researchers intend to determine a causal relationship between the variables. This research focus would be better addressed with a quantitative, experimental design.

Table 4.2 Research Methods and Examples of Purpose Statement Verbs

Qualitative Methods Quantitative Methods

Ethnographic Assess Describe Examine Understand

Correlation Determine Examine Identify Understand

Grounded Theory Descriptive

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Develop Extend Identify Validate

Compare Contrast Describe Identify

Phenomenological Describe Develop Generate Understand

Experimental Determine Examine Investigate Measure

Differentiating Research Problem Statements and Research Purpose Statements Research problem statements are declarations of disparity (why); research purpose statements are declarations of intent (what). Although problem statements and purpose statements clarify and support each other, they represent different levels of the deductive process—that is, the process of moving from a general focus or interest to the development of a specific research question. As researchers identify problems, explore disparities or gaps, and develop problem and purpose statements, the focus of the research narrows, increasing the feasibility of carrying out the study as intended.

Problem and purpose statements are not limited to research based on empirical measurement—that is, to quantitative studies. Qualitative studies use subjective means to describe and examine concepts and their meanings, but will still have an identifiable problem focus and purpose statement. The problem and purpose statements of qualitative studies may be vaguer and less prescriptive than those for quantitative studies, primarily due to the emergent nature of research design in qualitative research. Although an overall problem is generally identified for a qualitative study, the purpose may be broader and less detailed than that of a quantitative study because the particulars of the study may become clear only after data collection has commenced. In other words, qualitative problem and purpose statements are more general and allow for the flexibility that is characteristic of an emergent design (Boswell & Cannon, 2012; Schmidt & Brown, 2011). Quantitative studies, by their very nature, are more prescriptive and use objective measures to describe and examine concepts and the relationships between concepts. Thus, quantitative problem and purpose statements are generally detailed, are based in previous literature, and outline the variables, populations, and settings to be studied.

It remains important for a clear problem to be identified and a purpose statement to be articulated before either type of research design begins. Table 4.3 and Table 4.4 provide examples of problem and purpose statements for selected qualitative and quantitative research designs.

Developing the Research Question

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The problem statement is a general review of why a particular research study is necessary; the purpose statement gives an overview of the intent of the study. Neither of these is prescriptive enough to give specific guidance to the design and methodology of the study. Instead, a focused research question is necessary to fulfill this need. The research question is the final step prior to beginning research design, and it outlines the primary components that will be studied. In some cases, the research question is analogous to the purpose statement, but it is constructed as a question instead of a statement. Questions that are clear, simple, and straightforward provide direction for subsequent design decisions and enable the researcher to focus the research process.

Research question: A question that outlines the primary components to be studied and that guides the design and methodology of the study.

Table 4.3 Problem and Purpose Statements from Qualitative Research Studies

Design Problem and Purpose Statements

Ethnography Title: Parental involvement in neonatal pain management: Reflecting on the researcher-practitioner role (Skene, 2012) Problem statement: “I have been surprised to find that while the neonatal literature presents a description of what happens when parents in the neonatal unit are excluded from their babies’ pain management, it does not provide a picture of what happens when they are involved” (p. 27). Purpose statement: “To fill this gap, I began a study to answer the following research question: ‘How do parents interact with babies and nurses around the provision of comfort care in a neonatal intensive care unit where information and training in comfort care have been provided?’” (p. 27).

Grounded theory Title: Patients’ perspectives on timing of urinary catheter removal after surgery (Bhardwaj, Pickard, Carrick-Sen, & Brittain, 2012) Problem statement: “There is limited evidence to inform the patients’ perspective of short-term urinary catheterization after surgical procedures” (p. S4). Purpose statement: “The aims of the study were to: Explore patients’ beliefs and perceptions regarding perioperative urinary catheterization [and] Relate patients’ beliefs to current and future practice” (p. S4).

Phenomenological Title: Quality of life after ileo-anal pouch formation: Patient perceptions (Perrin, 2012) Problem statement: “Williams (2002), who studied preoperative pouch patients, highlighted that little attention is given to addressing their experiences of living with a pouch” (p. S11). Purpose statement: “This phenomenological research study explored whether having an ileo-anal pouch provides a good quality of life by asking six individuals who have undergone ileo-anal pouch formation about their own perception of their quality of life following ileo-anal pouch formation” (p. S12).

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Examples of well-written research questions from published articles follow:

“The research question explored was ‘Is the lived experience of being a nurse different depending on your gender?’” (Rowlinson, 2013, p. 219) “The research question was: Does volume of urine, diaper configuration, and size of diaper lead to statistically significant changes over time in the weight of infant disposable diapers?” (Carlisle et al., 2012, p. 224)

As questions are refined, they should be critiqued continuously. The simple act of writing the question down and asking for input from colleagues may help to focus and refine the question. Does it make sense? Is it logical? Is this question important for clinical care? Could this research yield practical benefits? This kind of feedback can help the nurse researcher generate a strong research question that provides guidance for subsequent research design and methodology. The time invested in carefully constructing the final research question is well worth the effort; it provides a foundation for the remaining decisions that must be made about the research process.

Table 4.4 Problem and Purpose Statements from Quantitative Research Studies

Design Problem and Purpose Statements

Correlation Title: The relationship between clinical indicators, coping styles, perceived support and diabetes-related distress among adults with type 2 diabetes (Karlsen, Oftedal & Bru, 2012) Problem statement: “To date, we have been unable to find any research that compares the relative contribution of (i) essential clinical indicators of diabetes regulation as listed in the introduction, (ii) coping styles, and (iii) perceived social support to the variation in diabetes-related distress among adults with type 2 diabetes” (p. 393). Purpose statement: “One aim of this study was to describe diabetes-related distress, coping styles, and perceptions of social support among adults with type 2 diabetes. The main aim was to investigate the extent to which (i) clinical indicators such as Hb , diabetes treatment, diabetes-related complications, disease duration and BMI, (ii) coping styles, and (iii) perceived support from healthcare professionals and family are related to diabetes-related distress” (p. 393).

Descriptive design

Title: Quality of life after percutaneous coronary intervention: Part 2 (Cassar & Baldacchino, 2012) Problem statement: “Quality of life (QoL) has been found to be affected by demographic factors and cardiac risk factors. Research that concentrates on physical health and functional ability after this coronary intervention gives only a partial picture of life quality (Groeneveld et al., 2007; Konstantina & Dokoutsidou, 2009; Moons et al., 2006; Seto et al., 2000; Szygula-Jurkiewicz et al., 2005)” (p. 1125). Purpose statement: “The study aimed to: Assess the holistic QoL of patients who have undergone a PCI [and] identify significant differences in QoL between subgroups of patients by demographic characteristics and perceived cardiac risk

A1c

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factors” (p. 1125).

Experimental Title: Pain after lung transplant: High frequency chest wall oscillation (HFCWO) vs chest physiotherapy (CPT) (Esquerra-Gonzalez et al., 2013) Problem statement: “Two studies used a randomized design to compare HFCWO and CPT on outcome variables of comfort and preference . . . No published studies have investigated which treatment is less painful and preferred by lung transplant recipients” (p. 116). Purpose statement: “Given the lack of evidence supporting the effectiveness of HFCWO and CPT among lung transplant recipients, the purposes of this pilot, feasibility study were to (1) explore the effect of HFCWO versus CPT treatment on patients’ pain patterns by measuring pain scores before and after treatment and (2) compare lung transplant recipients’ preference for HFCWO versus CPT” (p. 117).

The Elements of a Good Research Question Two guides are helpful in developing a good research question. One of them is described by the acronym PICO, which outlines the elements of a good quantitative question. PICO stands for population, intervention, comparison, and outcome. Using preoperative education for short-stay patients undergoing prostatectomy as an example, a research question based on PICO might look like this:

Population: In radical prostatectomy patients staying in the hospital one day after surgery . . . Intervention: Does customized preoperative teaching . . . Comparison: Compared to standard preoperative teaching . . . Outcomes: Lead to better pain control as measured by a visual analog scale?

A qualitative research question is the least prescriptive type of research question. It outlines, in a general way, the phenomenon to be studied and the people who can best inform the question. The researcher defines the general boundaries of the inquiry, but even these are subject to change. The study begins with the researcher having a general question in mind, but the researcher is flexible enough to change the particulars of the question if the information gathered suggests that step would be appropriate. Measurements, interventions, and comparison groups are irrelevant in qualitative research, so they are not parts of the qualitative question. Specification of outcomes may be incorporated into the qualitative question but are not necessary elements. Because qualitative questions may actually evolve over the course of the study, they are reported in detail only after the study is complete.

Clearly, the elements of the research question are very similar to those in the purpose statement. The primary distinction relates to format—a purpose statement is given as a statement, whereas a research question is stated as a question. In addition, the research question often spells out the outcome in a

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statement such as “as measured by the Wong Faces Pain Scale,” and so gives more specificity to what is to be measured.

A Well-Done PICO Question Among parents of children diagnosed with type 1 diabetes in a small Midwestern city, what are parents’ self-reported self-efficacy scores related to diabetic care management pre- and post-implementation of a web-based social support platform? (Merkel & Wright, 2012)

A Well-Done PICOT Question Will the implementation of a popup prompt in the health record increase adherence and decrease time to administration of aspirin from Emergency Department presentation of women who are having symptoms suspicious of acute cardiac syndrome? (Carman et al., 2013)

Box 4.1 PICO Versus PECO Versus PICOT Any research question will be strengthened by a systematic approach to developing some fundamental elements.

Population: In almost every study, the population addressed needs to be clearly identified. Begin by deciding how broad the population should be. Who are the specific people of interest? Can selecting a subset of this population as the sample make the study more focused and feasible? Are there specific conditions, risk factors, or characteristics that are of interest? By thinking through these elements, a clear population of interest may emerge. Describe the population as succinctly and specifically as possible. Intervention: Determine exactly what the “intervention” is for the study. What will the researcher introduce into the study or manipulate? Is the “cause” a naturally occurring characteristic? The former will be better represented in a PICO question; the latter in a PECO question (discussed later in this feature). Interventions may include process measures, specific treatment practices, or exposure to an event or substance. Describe the intervention or risk factor in a focused but clear way. Comparison: Without a comparison, all we can say about the intervention is that it was better than nothing. The object of comparison will likely be the standard practice, but it may also be a group without a risk factor. This issue does not usually require in- depth description in the statement of the research question. Outcomes: The outcome should reflect the nature, direction, and degree of results anticipated. This definition should be precise and, in most cases, will indicate the way the outcome will be measured.

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In many cases, the “intervention” is not introduced, so much as it is “found.” In these cases—where the effects of a naturally occurring event are of interest—some researchers prefer the PECO approach. PECO includes the following four elements:

Population of interest Control or comparison group Exposure to a factor of interest Outcome of interest

It is clear that the PECO approach mirrors the PICO method closely, except that the “intervention” is not manipulated or artificially introduced into the experiment. PECO research questions are commonly encountered in population health or epidemiology studies (McKeon & McKeon, 2015).

Some researchers recommend adding elements to the model. The most common extension is found in the PICOT model. The final “T” in this acronym stands for time, referring to the duration of data collection or the expected time to observe an effect (Carman et al., 2013).

The PICO model is not appropriate for every research problem. This format must be modified for descriptive studies—in which no intervention is applied—and for studies describing relationships. In these cases, the research question should include at a minimum a clear identification of the population and the variables being studied.

Another acronym—FINER—gives guidance in the appraisal of a research question. This model gives the nurse researcher a framework for evaluating the desirable characteristics of a good question:

Feasible: Adequate subjects, technical expertise, time, and money are available; the scope is narrow enough for study. Interesting: The question is interesting to the investigator. Novel: The study confirms or refutes previous findings, or provides new findings. Ethical: The study cannot cause unacceptable risk to participants and does not invade privacy. Relevant: The question is relevant to scientific knowledge, clinical and health policy, or future research directions.

Once the question is carefully defined, then the link to design elements often becomes obvious. If not, then the researcher may need to provide more specificity about the population, intervention, or outcomes in the research question. These three elements of the question will later provide guidance in the selection of a sample, the procedures, and the measurements.

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The Link Between Questions and Design Focusing the research question guides how that question will be answered. The question will lead to a sampling strategy (Who is the patient population?), an intervention protocol (Which treatment is being tested?), and the outcomes measured (How will the effect be demonstrated?). There are also direct links between the kind of words used in the question and the design that is used to answer it.

Descriptive questions ask simple questions about what is happening in a defined population or situation. For example, a descriptive question is “What are the characteristics of surgical patients reporting high satisfaction with pain management during their hospitalization?” Three general types of research questions are best answered with descriptive studies:

Resource allocation questions Questions about areas for further research Questions about informal diagnostic information

Most qualitative questions are answered with descriptive studies, because a qualitative study is generally descriptive of a single sample. The broad nature of a qualitative research question lends itself to a variety of methods, ranging from interviews to focus groups to observation. The specific verbiage used in the qualitative question may guide the study’s design, but in general the design emerges from the nature of the phenomenon under study, not from the particular way in which the research question is written.

Analytic studies compare one or more interventions to specific outcomes. For example, the questions “What is the effectiveness of individual or group educational sessions for hip surgery patients?” and “Is breast cancer associated with high fat intake?” may be answered with quantitative analysis. The objective of an analytic study is to determine whether there is a causal relationship between variables, so the research question reflects study of the effect of an intervention on one or more outcomes. Statistical procedures are used to determine whether a relationship would likely have occurred by chance alone. Analytic studies usually compare two or more groups.

Analytic studies are logical means to address questions that will be answered with numbers or with measurements. In this kind of quantitative study, the researcher performs tests related to the research question using statistical analysis. Although research questions are not directly testable with numbers, their transformed version—the hypothesis—is subject to numerical analysis. It is important, then, to translate quantitative research questions into hypothesis statements that lend themselves to statistical analysis.

From Question to Hypothesis

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Just as the research question guides the design of a study, so a hypothesis guides the statistical analysis. A research hypothesis is a specific statement that predicts the direction and nature of the results of a study. It can be complex or simple, directional or nondirectional, and stated in statistical symbols or narrative form (Connelly, 2015). The way a hypothesis is written determines which tests are run, which outcome is expected, and how conservative the results are. A hypothesis is a restatement of the research question in a form that can be analyzed statistically for significance. It is specifically used in causal tests, such as experimental designs and quasi- experimental designs. For example, the research question “What is the association of environmental factors and reactive airway disease in otherwise healthy adults?” can be rewritten as the hypothesis “There is no association between environmental factors and reactive airway disease in otherwise healthy adults.” Although stating that no relationship exists might seem a counterintuitive way to start a research analysis, it is, in fact, the only way that statistical significance can be measured. Although we can never be sure that a relationship exists, we can calculate the probability that it does not. Testing a null hypothesis in effect tells us how much uncertainty is present in the statistical conclusions, so the researcher can judge if it is within an acceptable range.

Hypothesis: A restatement of the research question in a form that can be analyzed statistically for significance.

Two characteristics make a good hypothesis: the statement of an expected relationship (or the lack of a relationship) and an identified direction of interest. A null hypothesis states there is no difference between groups as a result of receiving the treatment or not receiving the treatment, whereas an alternative hypothesis specifies an expected difference between treatment groups. In either case, the relationship between variables is defined.

Null hypothesis: A statement of the research question that declares there is no difference between groups as a result of receiving the intervention or not receiving the intervention.

With respect to directionality, a nondirectional hypothesis is one for which the researcher is interested in a change in any direction, good or bad. In other words, a positive or negative association would be of interest. If we were testing a drug for hypertension, for example, a nondirectional hypothesis would indicate we are interested in reductions in blood pressure, but we would also be interested in rises in blood pressure. Sometimes called two-sided hypotheses, nondirectional hypotheses are appropriate for exploratory research questions or randomized trials of interventions. They require more rigorous tests than directional hypotheses. Research questions are often used

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alone, rather than being paired with hypotheses, when no direction of influence is predicted (Connelly, 2015); thus, studies with nondirectional hypotheses may not state them explicitly.

Nondirectional hypothesis: A two-sided statement of the research question that is interested in change in any direction.

Directional hypotheses, or one-sided tests, are interested in only one direction of change. They are appropriate for research questions in which a great deal of literature or empirical support for an existing relationship can be found. Directional hypothesis tests are more liberal than nondirectional ones.

Directional hypothesis: A one-sided statement of the research question that is interested in only one direction of change.

A good hypothesis statement includes the population, variables (dependent and independent), and the comparison (Boswell & Cannon, 2012). Using preoperative education for short-stay patients undergoing prostatectomy as an example, a research hypothesis might look like this:

Population: In patients who undergo radical prostatectomy and stay in the hospital one day after surgery . . . Comparison: There will be no difference in . . . Dependent variable: Pain control as measured by a visual analog scale . . . Independent variables: Between patients receiving customized preoperative teaching and standard preoperative teaching.

It is easy to see the analogy between a PICO question and a hypothesis. In this example, the “I” of the PICO question is the independent variable, and the “O”, or outcome, is the dependent variable. Note, however, that hypotheses are sequenced slightly differently than PICO questions. Hypotheses are best used for experimental designs, but they can serve as a PICO statement when the results will be statistically driven.

Examples of null, alternative, directional, and nondirectional research hypotheses appear in Table 4.5.

GRAY MATTER Two essential aspects of a good hypothesis are

A statement of an expected relationship (or lack of one) An identification of a direction of interest

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Reading Research for Evidence-Based Practice The primary reason for critically reading problem statements is to identify concerns or problems and to understand the disparities or gaps between what is known and what still needs to be known about concepts. A secondary reason is to determine the significance of the concerns or problems. The primary reason for critically reading purpose statements is to identify the variables and study design within the context and scope of specific populations and settings. A secondary reason is to determine feasibility and fit.

When reading research as evidence for practice, many novice researchers are tempted to search by key words, retrieve by titles, and scan conclusion sections of abstracts and articles. In fact, novice researchers should avoid such practices. Instead, the problem and purpose statements must be reviewed to ensure fit between the nurse’s problem and purpose and the researcher’s problem and purpose. Does the problem statement address the same or similar concepts and gaps in knowledge? Does the purpose statement address the same or similar variables, populations, and settings? Often these elements are defined and explained in the introduction, literature review, and study design sections of a research report.

Problem and purpose statements, as well as research questions, should be stated early in the research report. The problem statement may be inferred and incorporated into the introduction and review of the need for the study. Often the context of the problem appears in the literature review. The purpose statement should be explicit and found near the beginning of the study; it might also be called “objectives,” “aims,” or “goals.” The research question itself should be specific and made clear early in the study. The study may or may not report hypotheses, even if it is clearly quantitative and experimental in design. If they are reported, hypotheses often appear in the results section with their associated statistical conclusions.

Table 4.5 Examples of Hypotheses

Research Question Null Hypotheses Alternative, Nondirectional Hypotheses

Alternative, Directional Hypotheses

Do collaborative interdisciplinary rounds change the nurse’s perception of collaboration on a patient care unit?

There will be no difference in nurses’ perception of collaboration when interdisciplinary rounds are implemented on a patient care unit.

Nurses’ perception of collaboration will be different when interdisciplinary rounds are implemented on a patient care unit.

Nurses’ perceptions of collaboration will be improved when interdisciplinary rounds are implemented on a patient care unit.

Does a school-nurse educational campaign on the importance of

There will be no difference in the average amount of

Middle school students will have a different average

Middle school students will have a greater average

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sleep change the average amount of school-night sleep of middle school students?

school-night sleep among middle school students as a result of a school-nurse educational campaign.

amount of school- night sleep as a result of a school- nurse educational campaign.

Using Research in Evidence-Based Practice By understanding problems, their related concepts or variables, the definition of the population, and the context for a research study, the nurse may be able to generalize the findings from that study to his or her specific nursing practice. The best evidence may then be used to design changes to improve processes and outcomes.

Literature searches may produce hundreds or even thousands of applicable and nonapplicable results. To easily and quickly identify applicable studies, look for the problem statements and the purpose statements in research reports. Problem statements and purpose statements provide readers with the focused context and scope required to generalize research findings to their own nursing practice and establish and support evidenced-based practice within their organizations. Efficient literature searches include not only key words related to research problems, but also key words related to the level of evidence. For example, key words such as meta-analysis, randomized, or controlled may yield higher levels of evidence for critiquing, weighting, and synthesizing activities (Facchiano et al., 2011).

Creating Evidence for Practice Finding and developing research problems begins with a general concern or focus related to a subject or topic. Subjects and topics consist of broad categories and may include examples such as hospital-acquired infections, pain management, patient falls, physiological monitoring, and pressure ulcer prevention. As the process evolves, a problem is identified. Research problems consist of narrower topics and may include examples such as ventilator-associated pneumonia, patient-controlled analgesia, blood pressure monitoring, and use of specialty beds to prevent skin breakdown.

Once a problem is identified, the gap between what is known about the problem and what remains to be known about the problem is examined. Special consideration should be given to exploring the gap within the context and scope (population and setting) of the problem. This gap examination occurs primarily through a literature review. Research activities should focus on narrowing or filling in the gaps.

After the gap has been identified, the problem statement(s), purpose statement(s), and research question(s) are developed. The problem statement indicates the focus or interest of the study and raises concerns and questions (disparities and gaps) about general concepts. The purpose statement

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indicates why the study is being conducted and suggests methods for examining the concepts or variables, and the relationships among them, within a specific population and setting. The research question is a rewording of the purpose statement into a question that suggests methods for examining the concepts or variables and the relationships between them.

CHECKLIST FOR CRITICALLY READING PROBLEM STATEMENTS Development

❏ Deductive narrowing from the general to the specific

Articulation

❏ The problem is stated or inferred

❏ The statement is provided early in the article and is easy to find

❏ The concern, disparity, or gap is clear

Significance

❏ Develops, expands, or validates nursing knowledge

❏ Develops, expands, or validates conceptual models or theoretical frameworks

❏ Improves patient care, staff member, and/or organizational processes and/or outcomes

CHECKLIST FOR CRITICALLY READING PURPOSE STATEMENTS Development

❏ Deductive narrowing from problem statement

Articulation

❏ The purpose is stated or inferred but can be described

❏ The statement is provided early in the article and is easy to find

❏ The purpose is written as a statement

❏ The statement uses an unbiased verb

❏ The design is described

❏ The variables are described

❏ The population is defined

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❏ The setting is specified

Feasibility

❏ Required resources (people, time, money, equipment, materials, and facilities) are accessible

❏ Ethical issues have been considered

Fit

❏ There is obvious alignment between purpose statement and design

You should look for information about the research question or hypothesis in the following places:

The research question may be explicitly stated in the research abstract, but is often simply implied by the title of the article, purpose statement, or objectives for the study. Ideally, the question is discussed at the beginning of the article, often at the end of the introduction. When it is stated early, it is followed by evidence from the literature review to support the researcher’s contention that this question is important to investigate further. It may be written as a statement instead of a question. If it is not found at the beginning of the research report, look for the question at the end of the literature review. The null and alternate hypotheses are often found in the methods section where statistical methods are discussed, along with the rationale for the statistical tests used to test the hypotheses. Hypotheses are typically easy to find and are explicitly identified as such. Sometimes a separate section is created for a formal statement of the problem, the purpose of the study, and the research question. It may be labeled “Purpose,” “Aims,” or “Objectives.” The research question may similarly have its own heading. If the researcher used any inferential statistical tests, which most quantitative studies do, then there were hypotheses, whether they are stated or not. Sometimes the reader needs to guess what the hypotheses were, based on the tests that were reported. Most studies do not report a hypothesis. This is not a weakness; except for the most scientific of journals, formal explication of hypotheses is not a standard part of a write- up.

That said, there may be no properly constructed research question explicitly stated in the report. Three researchers in rehabilitation medicine reviewed more than 250 research articles to identify what proportion of them described appropriate research questions. More than 30% of the articles reviewed had

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questions that required reworking to match the work undertaken (Mayo, Asano & Barbic, 2013). When the research question is not specifically identified, the reader may need to infer the elements of the research question from the descriptions of the study’s design, methods, and sampling.

SKILL BUILDER Write Stronger Research Questions The most important part of the research process is getting the question right. How the problem is stated determines which measures will be used, which data will be collected, which kind of analysis will be used, and which conclusions can be drawn. It is worth the time, then, to carefully consider how this element of the research study is developed. A thoughtful process does not necessarily mean a complicated process, however. Here are some simple suggestions for creating strong research questions:

Answer the “why” question first. With a solid understanding of the reason for the study, the specifics of the research question become easier to identify. Review the literature before finalizing the question. Do not hesitate to replicate the question of a research study that accomplishes similar goals. It is flattering to researchers—even established, well- known ones—to have their work replicated. Be sure to give credit where credit is due. Focus, focus, focus. Refine the research question, mull it over for a bit, and then refine it again. The effort spent to get the question just right will be worth it, because less confusion will arise later about how to answer the question. That said, do not wait until the question is perfect to begin the design of the study. The question is, to some extent, a work in progress as the specifics of the research unfold. The question can, and likely will, be revised as new information, resources, and constraints come to light. Keep the research questions focused; do not include more than one major concept per question. Compound questions are challenging to study and make it more difficult to isolate the effects of a single independent variable. Multiple research questions should be used instead of multiple parts of a single question.

Summary of Key Concepts Finding and developing significant problems for research are critical for improving processes and outcomes for patients, staff members, and organizations. For both the researcher and the reader, problem statements, purpose statements, and research questions serve to guide and direct research activities.

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The evolution of a research problem from a general topic of interest to the articulation of a problem statement and a purpose statement serves to narrow the focus of the research to a researchable question. Subjects or topics that are too broad are problematic for researchers—because methodological complexities increase, experienced researchers or consultants are required, and resource demands (for example, money, people, and time) increase. Sources for researchable problems include clinical practice, educational institutions, consumer/customer feedback, personal experience, frameworks and models, professional literature, performance improvement activities, research reports and priorities, and social issues. Research problem statements are declarations of disparity: the difference (gap) between what is known and what needs to be known about a topic. They are written as questions or statements and contain clear, concise, and well-defined components (disparities or gaps and concepts). Research purpose statements are declarations of intent: what will be studied, how it will be studied, who will be studied, and what the context for the study is. They are written as declarative, objective statements and contain clear, concise, and well-defined components (design, variables, population, and setting). There should be a good fit between the design suggested in the purpose statement and the methods used in the research study. There should also be a good fit between the research question and the specifics of the research design, sampling strategy, and measurement. Qualitative problem and purpose statements, as well as research questions, are generally broader, vaguer, and less prescriptive than those created for quantitative studies. Qualitative designs are emergent and may be revised frequently as the study unfolds. Research questions for quantitative studies can be developed using the PICO guide by specifying population, intervention, comparison, and outcome. Some researchers add a “T” to the PICO acronym (PICOT) to identify the time period of interest. Epidemiology studies often use questions constructed in the “PECO” format, in which an exposure of interest is substituted for an intervention. All elements will not necessarily be in every question, because PICO guidelines are most appropriate for experimental designs. The FINER criteria—feasible, interesting, novel, ethical, and relevant— serve as a good basis for analysis of the quality of a researchable question. The research question should have an identifiable link to the research design.

For More Depth and Detail For a more in-depth look at the concepts in this chapter, try these references:

Chang, S., Carey, T., Kato, E., Guise, J., & Sanders, G. (2012). Identifying research needs for improving health care. Annals of Internal

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Medicine, 157(6), 439–445.

Curley, M. (2012). Clinical research: Together, stronger, bolder. American Journal of Critical Care, 21(4), 234–241.

Houghton, C., Hunter, A., & Meske, U. (2012). Linking aims, paradigm and method in nursing research. Nurse Researcher, 20(2), 34–39.

Krill, C., Raven, C., & Staffileno, B. (2012). Moving from a clinical question to research: The implementation of a safe patient handling program. Medsurg Nursing, 21(2), 104–116.

O’Brien, M., & DeSisto, M. (2013). Every study begins with a query: How to present a clear research question. NASN School Nurse. doi: 10.1177/1942602X12475094 Toledo, A., Flikkema, M., & Toledo- Pereyra, L. (2011). Developing the research hypothesis. Journal of Investigative Surgery, 24(5), 191–194.

Welford, C., Murphy, K., & Casey, D. (2011). Demystifying nursing research terminology: Part 1. Nurse Researcher, 18(4), 38–43.

Welford, C., Murphy, K., & Casey, D. (2012). Demystifying nursing research terminology: Part 2. Nurse Researcher, 19(2), 29–35.

CRITICAL APPRAISAL EXERCISE Retrieve the following full-text article from the Cumulative Index to Nursing and Allied Health Literature or similar search database:

Baker, N., Taggart, H., Nivens, A., & Tillman, P. (2015). Delirium: Why are nurses confused? MedSurg Nursing, 24(1), 15–22.

Review the article, looking for information about the problem and purpose statements and the research questions and hypotheses. Consider the following appraisal questions in your critical review of these elements of the research article:

1. These authors do not specify a problem statement, or a statement about the gap between what is and what is not known about the problem. From the authors’ introduction and review of the literature, what can you infer is the problem they want to address?

2. Are the research questions appropriate to achieve the given purpose of the study?

3. Does the research question meet the FINER criteria? Why or why not?

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4. Which elements of the PICO question are evident here? How could these questions be strengthened using a PICO approach?

5. Are these hypotheses directional or nondirectional? 6. Discuss whether and how this study will contribute to nursing

practice.

References American Association of Colleges of Nursing (AACN). (2013).

Nursing research. Retrieved from http://www.aacn.nche.edu/publications/position/nursing- research

Bhardwaj, R., Pickard, R., Carrick-Sen, D., & Brittain, K. (2012). Patients’ perspectives on timing of urinary catheter removal after surgery. British Journal of Nursing, 21r(18), Urology Supplement, S4–S9.

Boswell, C., & Cannon, S. (2012). Introduction to nursing research: Incorporating evidence-based practice (3rd ed.). Burlington, MA: Jones & Bartlett Learning.

Carlisle, J., Moore, A., Cooper, A., Henderson, T., Mayfield, D., Taylor, R., . . . Sun, Y. (2012). Changes in infant disposable diaper weights at selected intervals post-wetting. Pediatric Nursing, 38(4), 223–226.

Carman, M., Wolf, L., Henderson, D., Kamienski, M., Koziol- McLain, J., Manton, A., & Moon, M. (2013). Developing your clinical question: the key to successful research. Journal of Emergency Nursing, 39(3), 299–302.

Cassar, S., & Baldacchino, D. (2012). Quality of life after percutaneous coronary intervention: Part 2. British Journal of Nursing, 21(19), 1125–1130.

Centers for Medicare & Medicaid Services Partnership for Patients (CMS). (2013). Retrieved from http://partnershipforpatients.cms.gov/

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Connelly, L. (2015). Research questions and hypotheses. MedSurg Nursing, 24(6), 435–436.

Esquerra-Gonzalez, A., Ilagan-Honorio, M., Fraschilla, S., Kehoe, P., Lee, A., Marcarian, T., . . . Rodman, B. (2013). Pain after lung transplant: High frequency chest wall oscillation vs chest physiotherapy. American Journal of Critical Care, 22(2), 115–125.

Facchiano, L., Snyder, C., & Nunez, D. (2011). A literature review on breathing retraining as a self-management strategy operationalized through Rosswurm and Larrabee’s evidence-based practice model. Journal of the American Academy of Nurse Practitioners, 23(8), 421–426.

Hospital Care Quality Information from the Consumer Perspective (HCAHPS). (2013). Retrieved from http://www.hcahpsonline.org/home.aspx

Karlsen, B., Oftedal, B., & Bru, E. (2012). The relationship between clinical indicators, coping styles, perceived support and diabetes-related distress among adults with type 2 diabetes. Journal of Advanced Nursing, 68(2), 391–401.

Mayo, N., Asano, M., & Barbic, S. (2013). When is a research question not a research question? Journal of Rehabilitation Medicine, 45, 513–518.

McKeon, J., & McKeon, P. (2015). PICO: A hot topic in evidence-based practice. International Journal of Athletic Therapy & Training, 20(1), 1–3.

Merkel, R., & Wright, T. (2012). Parental self-efficacy and online support among parents of children diagnosed with type 1 diabetes mellitus. Pediatric Nursing, 38(6), 303–308.

Patient-Centered Outcomes Research Institute (PCORI). (2013). Retrieved from http://www.pcori.org/

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Perrin, A. (2012). Quality of life after ileo-anal pouch formation: Patient perceptions. British Journal of Nursing, 21(16), Stoma Care Supplement, S11–S19.

Rowlinson, L. (2013). Lived experience of being a nurse. British Journal of Nursing, 22(4), 218–222.

Schmidt, N., & Brown, J. (2011). Evidence-based practice for nurses: Appraisal and application research. Burlington, MA: Jones & Bartlett Learning.

Skene, C. (2012). Parental involvement in neonatal pain management: Reflecting on the researcher-practitioner role. Nurse Researcher, 19(4), 27–30.

White, E. (2012). Challenges that may arise when conducting real-life nursing research. Nurse Researcher, 19(4), 15–20.

Williams, J. (2002). The Essentials of Pouch Care Nursing. London, England: Whurr Publishing Ltd.

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Chapter 5: The Successful Literature Review

CHAPTER OBJECTIVES The study of this chapter will help the learner to

Discuss the rationale for conducting a thorough search of the literature. Discuss tools that measure the impact of studies. Review the concept of “open access” and describe how it is making research information more accessible. Describe the types of literature used to support a research study, including studies that constitute the “evidence pyramid.” Understand the steps of a well-thought-out search strategy to find evidence-based information. Compare a literature search for research to a literature search for a practice guideline. Critically appraise the literature review section of a research article. Reflect on the ways that research literature can be used as evidence for nursing practice.

KEY TERMS Altmetrics

Bibliometrics

Boolean operators

Cited reference search

Empirical literature

Evidence pyramid h-Index

Information literacy

Journal impact factor

Levels of evidence

Literature review

Open access

Peer review

Primary sources

Scholarly

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Search concepts

Search strategy

Search terms

Secondary sources

Seminal work

Subject headings

Systematic review

Theoretical literature

An Introduction to the Literature Review The literature review is a critical component of the research process. It provides an in-depth analysis of what is known and what is missing related to a specific subject. This forms the foundation for research and ultimately patient care. Through online access to health information, today’s students and professionals can tap into a wide variety of complex resources that provide an unending source of data. Moreover, this information is so dynamic that the nurse researcher or clinician can no longer rely on a handful of familiar resources, but rather must constantly remain alert to new findings from a multitude of sources. In turn, nurses must develop the skills needed to search health sciences databases efficiently and to assess the authority, objectivity, and validity of the information they retrieve.

Literature review: A critical component of the research process that provides an in-depth analysis of recently published research findings in specifically identified areas of interest. The review informs the research question and guides development of the research plan.

VOICES FROM THE FIELD I was on the Evidence-Based Practice (EBP) Council for my hospital, and one of the questions we wanted to study was whether hourly rounding—a nurse checking every patient, every hour, and documenting it—was worth the amount of time it required of the nurse. The policy had come down from administration, and the rank and file who were expected to carry it out were not sure it would achieve the expected outcomes of decreasing the number of adverse events and enhancing patient satisfaction.

We talked about designing our own little study, but concluded we would see if there was already enough literature to show its effectiveness. We started with the question, “What are the outcomes associated with

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hourly rounding?” and identified search terms. We found quite a bit of literature through our initial search, but much of it focused on physicians’ rounds, not nurses’. We asked the health sciences librarian for help, and she combined our terms in novel ways that brought us more focused literature. She also helped us search dissertations and conference proceedings. This turned up a few dozen applicable abstracts. After applying our criteria to the list, we ended up with six articles that measured some aspect of hourly rounding. One of them was a review of other articles, so that was like hitting the evidence jackpot.

We started the study expecting to prove that hourly rounding did not really improve things. What we found—when we used objective criteria for including studies—was that evidence supported the effectiveness of this policy. Adverse events were decreased in two of the studies; patient satisfaction improved in almost all of them. So we were both surprised and a bit dismayed by the findings: We found something we did not expect that supported continuing a time-consuming policy.

When we looked closer, however, it became clear that it was the nurse contact that made the difference. That did not surprise us when we thought about it. There really was no evidence that we needed in-depth documentation of the rounding for it to be effective. So we suggested to our nurse administrator, “We recognize the evidence for hourly rounds, but can we find a faster way to show it was done?” We brainstormed for some time and decided the rounds could just be marked off on a small whiteboard in the room. Check the patient, check the whiteboard.

This was a case when the literature showed us something we did not expect but helped us pose alternative solutions. I think it convinced most of the team of the value of going to the literature first—you do not have to reinvent the wheel—and doing so in an objective, deliberate way.

Eunice Nolan, RN, DNP

While this chapter can serve as a guide for nurses to help them find evidence- based information, both students and professionals should not hesitate to contact a health sciences librarian for further assistance. Whether they work at a major academic center or in a one-room hospital library, such librarians are skilled at searching the relevant resources and are experts in the science of comprehensive literature retrieval.

Purpose, Importance, and Scope of the Literature Review Literature reviews add credence to the researcher’s assertions of the importance of the topic proposed for investigation. It is the researcher’s

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responsibility to determine what others have discovered on the same topic. A thorough literature review may turn up studies that can be replicated, instruments that have been standardized and tested for use, or procedures that can be adapted to the proposed study. In addition, the literature often reveals an appropriate theoretical framework.

The literature review may enhance the body of knowledge on a particular issue, or it may establish that there is a paucity of knowledge on the subject in question. Although many researchers are discouraged by a lack of published findings on a specific topic, this may actually be a benefit. A gap in the knowledge of a healthcare issue creates an area that is ripe for exploratory or interventional study and signals that the researcher is pioneering a new issue for investigation. It also increases the likelihood of publication and can serve as the basis for advanced academic study. Either way, the literature review is the first step in evaluating the importance of a research question and potential methods for its study.

Although the researcher needs to provide substantial literature support that directly relates to the problem, it is important to resist the temptation to include everything. A researcher must decide when to stop searching—perhaps an obvious point in theory, but one that is sometimes difficult to put into practice. A researcher may want to consciously note that nothing new is being revealed or that literature resources are exhausted. The scope of a scholarly literature review will obviously go into greater depth than a literature review for a small bedside science project. Likewise, a study directed toward a journal focused on practice may have fewer references than one intended for publication in a research journal. The type of study, the expectations of the readers, and the level of scholarly sophistication required will drive the scope of the literature review.

Scholarly: Concerned with or relating to academic study or research.

GRAY MATTER A literature review will

Add credence to the importance of the topic proposed for investigation Identify studies that can be replicated, instruments that have been standardized and tested, or procedures that can be adapted Reveal appropriate theoretical frameworks Contribute to the body of knowledge or establish the lack of published research on a subject

Types of Literature Used in the Review 167

Multiple types of information are used to enhance the scope and depth of the review, and one way to consider them is to recognize theoretical versus empirical literature. Theoretical literature includes published conceptual models, frameworks, and theories. It provides a basis for the researcher’s belief system and a road map for ways to think about the problem under study. Empirical literature, by comparison, includes works that demonstrate how theories apply to individual behavior or observed events. Both types of literature may take the form of research journals, books, theses and dissertations, conference proceedings, government reports, and practice guidelines.

Theoretical literature: Published conceptual models, frameworks, and theories that provide a basis for the researcher’s belief system and for ways of thinking about the problem studied.

Empirical literature: Published works that demonstrate how theories apply to individual behavior or observed events.

GRAY MATTER Scholarly literature includes the following types of sources:

Journals Books Conference proceedings Practice guidelines Theses and dissertations Government reports

Comprehensiveness in terms of both the time period reviewed and appropriate coverage of the subject matter is important. The delay between completion of a research study and the publication of its results can be significant; thus articles that are more than a few years old may refer to findings that are, in reality, much older. Researchers continually discover new facts, methods, and outcomes, which in turn change what is known about a subject. Consequently, the healthcare literature is highly dynamic. Failure to keep up with the latest findings or recommendations can potentially affect patient care, so it is essential for healthcare providers to keep abreast of the evolving literature.

There are exceptions to every rule, of course. A seminal work—one that is a classic in its field—may go back many more years than is common in the healthcare literature and is not bound by time. For example, the important contributions to the literature made by Florence Nightingale, Dorothea Orem,

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and Jean Watson—all trailblazers in the field of nursing theory—are considered seminal works. Likewise, research supporting statistical treatments or measurement instruments may be from less recent literature, if one can show that they are still relevant and their properties are still applicable to today’s practice.

Seminal work: A classic work of research literature that is more than 5 years old and is marked by its uniqueness and contribution to professional knowledge.

Research literature may be further defined in terms of its sources. Primary sources are reports of original work that are published in a peer-reviewed journal, government report, manuscript, or other scholarly work. Secondary sources include comments on and summaries of multiple research studies on one topic. For example, reviews of studies that provide synopses of clinical studies are secondary sources. If the conclusions drawn in the secondary source are based on that author’s interpretation of the primary work, it is necessary, then, to review primary sources whenever possible to ensure accuracy. Table 5.1 defines primary and secondary sources and gives examples for each.

Primary sources: Reports of original research authored by the researcher and published in a scholarly source such as a peer- reviewed research journal or scholarly book.

Secondary sources: Comments and summaries of multiple research studies on one topic, such as systematic reviews, meta-analyses, and meta-syntheses, which are based on the secondary author’s interpretation of the primary work.

Searching for the Evidence in a Research Problem Selecting the appropriate resource, often an online database, is among the most important initial steps in the literature search. Electronic databases vary in subject (e.g., biomedical versus nursing), search interface (the search engine and appearance), content type (e.g., bibliographic records versus full text), and indexing (e.g., subject headings versus searching for key words), among other characteristics. A researcher can spend an inordinate amount of time searching in a broad science database when, in fact, the question is more appropriately addressed in a specialized database. Additionally, books, dissertations, websites, and individual journals will yield relevant and authoritative information not included in major databases.

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Table 5.1 Primary and Secondary Sources of Information

Primary Source Definition Resources that publish the findings of original research and other types of studies in their first and original form

Examples of resources with primary source information

Clinical trials Dissertations/theses

Potential search tools and sources

CINAHL MEDLINE/PubMed PsycINFO Cochrane Central Register of Controlled Trials

Secondary Source Definition Resources that synthesize, summarize, or comment on original research

Examples of resources with secondary source information

Systematic reviews Meta-analyses Qualitative synthesis Reviews of individual articles Clinical practice guidelines

Potential search tools and sources

CINAHL MEDLINE/PubMed PsycINFO Cochrane Database of Systematic Reviews National Guidelines Clearinghouse (AHRQ) Professional association databases of practice guidelines Clinical point-of-care tools (e.g., UpToDate)

A well-planned search strategy is helpful in ensuring that the literature search is comprehensive and unbiased. The PICO statement (population, intervention, comparison, outcome) is a useful tool that aids in identification of major concepts for the search (Carman et al., 2013).

Open Access Many databases and sources of literature are proprietary; in such a case, individual researchers or an organization must be a subscriber to gain access to them. In recent years, digital technology has dramatically increased the ease of dissemination and access to research results, building an expectation that everyone—not just subscribers—should have access to articles published in scholarly journals, especially publications resulting from government-funded (i.e., taxpayer-funded) research. The open access movement has gained prominence in response to readers and authors alike demanding that research information be readily available. The most frequently quoted definition of open access (OA) literature, attributed to Peter Suber, Director of the Harvard Open Access Project, is “digital, online, free of charge, and free of most copyright and licensing restrictions” (Suber, 2004).

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Open access:Information that is freely available online with few or no copyright restrictions.

Researchers, healthcare professionals, patients, and funding agencies have been urging scholarly publishers to provide research information freely and to permit unlimited downloading, copying, distributing, and printing of the articles, or data-mining for analysis. In the United States, the National Institutes of Health’s (NIH) Public Access Policy requires that authors of articles that result from research funded by NIH submit their work to PubMed Central, a free digital repository of peer-reviewed articles, within 12 months of publication (Consolidated Appropriations Act, 2007). In early 2013 and again in 2015, Congress introduced and reauthorized the Fair Access to Science and Technology Research Act (FASTR) (2015a, 2015b), which takes the NIH policy a step further, by requiring open access within 6 months of publication in a peer-reviewed journal.

With the growing strength of the open access movement, it is increasingly feasible for nurses, whether affiliated with an academic institution or not, to readily access evidence-based information.

Assessing Study Quality and Its Influence How can readers of research publications be assured of the quality of the information? One of the hallmarks of high-quality research is peer review of the study’s rationale, design, methodology, results, and conclusions. Peer- reviewed publications have been subjected to critical assessment provided by “blinded” reviewers who are unaware of the author’s name, credentials, or professional status. This practice ensures a thorough evaluation of the paper using the same standard applied to other, similar works, without being influenced by the status of the author. When a researcher submits his or her manuscript to a peer-reviewed (sometimes called refereed) professional journal, it is understood that it will be evaluated by a team of experts who are experienced in the content and methodology reflected in the manuscript. This rigorous review process adds legitimacy to the findings reported in the study.

Peer review: The process of subjecting research to the appraisal of a neutral third party. Common processes of peer review include selecting research for conferences and evaluating research manuscripts for publication.

The peer review process itself, however, may vary. Quantitative research studies are generally subjected to a thorough analysis that focuses on potential sources of bias and error and then applies strict standards to the evaluation of methodology and design. Qualitative research, in contrast, lends

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itself more appropriately to peer review that focuses on the efforts the author has made to ensure credibility and trustworthiness.

Readers and authors alike may obtain further evidence of a study’s quality by examining the subsequent references to its publication. Authors must always attribute an idea or finding first reported in another publication by citing the source. In turn, the number of times an article is cited in other articles is an indication of the visibility and credibility of the work. With the help of online tools and applications, the discipline of bibliometrics (a term coined by Alan Pritchard in 1969) collects data on the impact of a publication. Pritchard (1969) defined bibliometrics as “the application of mathematics and statistical methods to books and other media of communication.” With the rise of digital information, the ability to track a scholarly publication’s impact and reach has greatly expanded.

Bibliometrics: The study of publication patterns.

Many methods exist that try to quantify this reach. The journal impact factor is a measure of the influence and ranking of a journal within a discipline (Thomson Reuters, 2015). The h-index is a calculation that provides a measure of a particular individual researcher’s output (Hirsch, 2005). A newer tool that looks at the extent of a publication’s influence is altmetrics, a method developed by Jason Priem. On his website (www.altmetrics.org), Priem and his colleagues (2010) define altmetrics as “the creation and study of new metrics based on the Social Web for analyzing and informing scholarship.” In their own literature searches, nurses will notice that publishers use various tools to discern an article’s impact.

Journal impact factor: A way to measure the visibility of research by calculating a ratio of current citations of the journal to all citations in the same time period.

h-Index: An indicator of a researcher’s lifetime impact in his or her field.

Altmetrics: The creation and study of new metrics based on the Social Web for analyzing and informing scholarship.

Competencies for Information Literacy It is clearly important that clinicians and researchers alike possess the competencies necessary to access, retrieve, and analyze research evidence for their practice throughout their career. Information literacy is important for

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nurses to acquire because they must decipher the vast expanse of knowledge generated through healthcare research. Nurses are required to make patient care decisions on a daily basis, so they must be able to incorporate evidence- based research into their clinical nursing practice. These skills can be mastered through repeated practice and application throughout the nursing curriculum, with feedback and instruction from the faculty in partnership with the health sciences librarian (Schardt, 2011). When students graduate, they then bring their information literacy skills to their employing organizations.

Information literacy: The competencies necessary to access, retrieve, and analyze research evidence for application to nursing practice.

Today, competent nurses must possess lifelong learning and information literacy skills that include the following abilities:

Identifying and succinctly stating the question or problem to be researched Using the appropriate online databases, websites of professional and government organizations, and other reliable resources for the retrieval of scholarly research and the best evidence Creating effective search strategies that yield relevant, current, research- based results Thinking critically to analyze problems and issues, and to appraise evidence Integrating evidence into practice Working with computers, the Internet, word processing, spreadsheet analysis, databases, and new applications that are relevant to the job

The process of searching the literature for evidence-based nursing resources begins with a focused clinical question that is limited in its time frame so that the evidence is current and directly applicable to nursing practice. Table 5.2 highlights some of the differences between a literature review for a research study and a literature review for the development of practice guidelines.

Table 5.2 Contrast of Literature Review for Research and for Practice Guideline Development

For a Research Study For Practice Guidelines

Conceptual basis

Provides background and context for the particular study that is planned Incorporates a theoretical framework Specific to the research question

Provides evidence that can be applied to a clinical problem Focuses on application of research to practice Specific to the clinical question

Type of evidence appraised

Scholarly works that are published in peer-reviewed journals Research reported in other peer-

Scientific works that are published in peer-reviewed journals Systematic reviews, meta-analyses,

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reviewed venues such as symposia, dissertations, and monographs

and integrative reviews published in journals, by professional associations, or by other organizations Opinions presented by expert panels or task forces

Critical appraisal skills used

Critical appraisal of single focused research reports

Critical appraisal of single studies and aggregate research report

GRAY MATTER A literature search for evidence-based nursing practice should meet the following criteria:

Be focused on a clinical question Be limited in its time frame so that the evidence is current Be applicable directly to nursing practice

Reading the Literature Review Section The literature review section of a research study provides rich information about the context of the study in the field and its potential for use in direct practice. Studies based on thoroughly searched and synthesized literature produce evidence that is more standard, easily aggregated, and likely to be valid. A well-done literature review section will support the authors’ contention that the research question is important and has significant implications for practice. It may also provide a link to the theoretical basis of the question and offer support for the methods and procedures used. The literature review should present a logical argument, in essence, that builds a case for the significance of the study and its particular design.

The literature review should include a variety of sources of data; these sources should be sorted and analyzed for their usefulness to the study. The literature review can be arranged in chronological order or by subject matter. The review should also be unbiased; that is, there should be a mix of previous studies related to the research question—some that support the author’s viewpoint and some that do not. Contradictory results from the literature should be reported, because one goal of nursing research is to clarify previous confusing results. Ideally, the studies should be dated within the past 5 years, unless the work is a seminal one or a theoretical selection.

WHERE TO LOOK A review of literature can appear throughout a published research article, but typically will be concentrated in a special section that follows the introduction, purpose statement, and research question. Citations to literature that support and discuss the scope of the research problem generally first appear in the literature review section, which may be

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labeled straightforwardly as “Literature Review”; alternatively, it may be called “Background” or “Context of the Problem.” On occasion, this information might not be presented in a separate section, but rather will be embedded into the introductory paragraphs.

Literature may also be cited to support the measurements that were used, the intervention protocol, or the data analysis procedures. The literature is often referred to during discussion and conclusions; it is here that the authors compare their findings to the findings of previous studies. In discussing the findings of their own study, the researcher should identify results that confirm previous studies, clear up contradictions, or highlight inconsistencies with the findings of other studies. Each citation in the text should be linked to an entry in the references list.

The use and placement of the literature review is standardized in most quantitative studies. Qualitative studies, however, may refer to and cite the literature in various ways. Some qualitative researchers believe the researcher should not have preconceived notions about a study and so should complete the literature search only after completing the study. Others use a fairly traditional approach. The literature review for qualitative studies often appears sprinkled throughout the sections noted earlier but may also appear in the results section, supporting the themes recorded and the words of informants.

CHECKLIST FOR EVALUATING AN EVIDENCE- BASED LITERATURE REVIEW

❏ The literature review relies primarily on studies conducted in the last 5 years.

❏ The relationship of the research problem to the previous research is made clear.

❏ All or most of the major studies related to the topic of interest are included.

❏ The review can be linked both directly and indirectly to the research question.

❏ The theoretical or conceptual framework is described.

❏ The review provides support for the importance of the study.

❏ The authors have used primary, rather than secondary, sources.

❏ Studies are critically examined and reported objectively.

❏ The review is unbiased and includes findings that are conclusive and those that have inconsistencies.

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❏ The author’s opinion is largely undetectable.

❏ The review is logically organized to support the need for the research.

❏ The review ends with a summary of the most important knowledge on the topic.

Using Evidence-Based Literature in Nursing Practice Nurses use literature reviews for a variety of reasons. Students will use them to compose scholarly papers and to design research studies. Practicing nurses may rely on literature reviews to make decisions supported by evidence when dealing with specific patient care problems. For the use of the profession as a whole, articles may be combined to develop evidence-based practice guidelines. All of these applications require competency in retrieving and using the literature appropriately. Table 5.3 highlights how nurses are expected to use the literature in education and in practice, while Table 5.4 reviews some of the ways that research literature is integrated into clinical practice.

When thinking about evidence-based literature, it may be helpful to visualize the various levels of information as a pyramid. Although many versions of this pyramid exist, one that has been widely cited and adapted for nursing research was produced through the efforts of librarians at Yale University and Dartmouth College (Glover, Izzo, Odato & Wang, 2006). The evidence pyramid (FIGURE 5.1) illustrates the hierarchy of literature related to the strength of the evidence presented. This literature may be associated with a level of evidence tool—that is, a ranking system that allows a clinician to quickly assess the quality of the evidence supporting a claim.

Evidence pyramid: A pyramid diagram illustrating evidence-based information that depicts the potential quality of information, the amount available, and the amount of searching required to find evidence.

Levels of evidence: A scale that provides the user with a quick way to assess the quality of the study design and, therefore, the strength of the study conclusions.

Table 5.3 Expectations for Use of Literature in Education and Practice

Baccalaureate (BSN) Conduct literature reviews on a clinical subject

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Critically appraise the data retrieved Synthesize summaries of literature Apply research findings to clinical practice Write academic papers Prepare academic presentations

Graduate The BSN skills plus the following:

Test the efficacy of nursing interventions yielding evidence for “best practices” Develop research and/or evidence-based proposals Develop research and/or evidence-based scholarly projects

Postgraduate The BSN and graduate skills plus the following:

Conduct research on proposals Publish research and/or evidence-based findings from own research Develop systematic reviews Collaborate with other nursing colleagues to develop future studies

Clinical Conduct literature reviews on a clinical subject being studied Critically appraise the data retrieved Synthesize summaries of the literature reviewed Apply research findings to clinical practice Develop research and/or evidence-based proposals Develop research and/or evidence-based scholarly projects

Table 5.4 Integration of Literature Review into Clinical Practice

Definition Application to Clinical Practice

Independent reading

Personal reading for enrichment and professional knowledge

Improvement of patient care Improvement of professional self

Journal clubs Group discussions regarding clinical issues and the scientific evidence that addresses them via critical appraisal of selected journal articles

Improvement of patient care Improvement of professional self Increase in new knowledge of clinical issues with associated evidence Learning research methodologies Learning new clinical practice techniques Discussing professional nursing issues

Research conferences

Professional meetings focusing on research findings

Improvement of patient care Improvement of professional self Increase in new knowledge of clinical issues with associated evidence Learning research methodologies Learning new clinical practice

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techniques Discussing professional nursing issues

Nursing practice councils/committees

A forum to research, craft, and revise nursing practice standards

Learning about evidence-based practice Development of professional practice guidelines: standards of care, procedures, protocols, and practice changes Identification of “best practices”

Performance improvement councils/committees

A forum that focuses on analysis and improvement of care

Evidence-based measurement outcomes: nursing-sensitive indicators Use of the plan–do–check–act (PDCA) or PICO assessment form for quality management

Peer reviews Processes wherein nurses review the practice of other nurses and compare actual practice to evidence-based professional standards

Promoting excellence in professional practice Identification of the need for safety and quality interventions

Data from Levin, R. F., & Feldman, H. R. (2006). Teaching evidence-based nursing. New York, NY: Springer.

The evidence pyramid model shows both filtered and unfiltered resources. Filtered resources are those that are reviewed by experts in the subject area and distilled into a publication such as a review, guideline, or evidence-based synopsis of a problem. The bottom section of the pyramid includes unfiltered works such as clinical trials, qualitative studies, and opinion pieces published by authors but not reviewed or appraised by others.

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FIGURE 5.1 Evidence Pyramid of Research Information

and Lei Wang. Retrieved from

http://www.dartmouth.edu/~biomed/resources.htmld/guides/ebm_resources.shtml

Systematic reviews are positioned at the top of this pyramid example. This type of literature is typically considered the highest level of evidence because multiple studies are judged related to a specific research question and reviewed to reveal the best practices or results pertaining to that question. As the pyramid indicates, there is generally less literature available at this level. The Cochrane Collaboration—a global partnership whose members have been developing systematic reviews since the early 1990s—creates such reviews, which are found in the Cochrane Database of Systematic Reviews (CDSR), part of the Cochrane Library. These systematic reviews are considered to be the gold standard of evidence. The Preferred Reporting Items for Systematic reviews and Meta-Analyses Guidelines describe steps for developing systematic reviews and provide specific guidance on the literature search involved in creating the review (Liberati et al., 2009).

Systematic review: A highly structured and controlled search of the available literature that minimizes the potential for bias and produces a practice recommendation as an outcome.

Critically appraised topics and articles are the next level in the evidence. These sources include guidelines developed on a specific health problem or

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articles reviewed for a journal club exercise.

Randomized controlled trials (RCTs) fall in the middle of the evidence pyramid. They include original research published in scholarly journals and indexed in bibliographic databases such as CINAHL and MEDLINE. The quantity of information here is vast, so a specialized topic is more likely studied. The most relevant information may be hidden in this abundance, however, and only someone with well-practiced search skills may be able to effectively locate it. Furthermore, these studies are not preappraised or filtered, so it is up to the researcher to assess the quality of the studies. Cohort and case-controlled studies are single studies that are also indexed in the bibliographic databases. The have less rigorous study designs than RCTs and, therefore, represent a lower level of evidence.

Expert opinion and background publications, such as encyclopedias and textbooks, fall at the lowest level of the pyramid. While important, these sources simply present the authors’ viewpoint based on their experience and knowledge or general information about a topic and may not be supported by research.

Creating a Strong Literature Review To successfully conduct a literature review, an organized approach must be used to address the clinical problem and research question. The most important steps are described here.

Identify the Research Problem and Question Clinicians and researchers are often inundated by information and data coming from many sources: the medical record, a physical examination, the patient’s story, practice guidelines, expert opinion, and the research literature. In the face of this wealth of data, it is easy to become overwhelmed. The key to finding evidence-based information is to boil it down to a handful of—and perhaps even one—searchable and ultimately answerable questions. The identification of these questions, in turn, presents the basic terms that are used for the literature search process. The study population, health problem, treatment options, differential diagnoses, prognosis, and expected outcomes are common considerations when formulating the research question. The PICO mnemonic takes many of these factors into account to help the searcher identify major concepts in the research problem.

Select the Resources Table 5.5 includes many resources for clinical and research information. Increasingly, clinical resources are available as mobile applications, which are also noted here. Professional journals that commonly focus on nursing research and evidence-based practice are listed in Table 5.6.

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Early in the literature review process, the researcher selects appropriate resources to locate prior studies that address the topic. The resource could be a review article with a lengthy bibliography, but it is often more fruitful to search an electronic resource that contains millions of records. This type of bibliographic database—that is, an electronic index of journal article citations —is searchable by key words, subject, author names, journal names, and other relevant categories.

Among the most important databases for nursing research is CINAHL (Cumulative Index to Nursing and Allied Health Literature), a collection of bibliographic records of articles, books, dissertations, and conference proceedings in nursing, biomedicine, and allied health. A subscription-based service, it is currently offered through EBSCO, a scholarly publisher.

Table 5.5 Databases and websites used for nursing Literature Searches

Databases Proprietary or Free

Comments

Academic Search Premier (EBSCO; http://www.ebscohost.com/academic/academic- search-premier)

Proprietary General science, social science bibliographic database.

ACP PIER (American College of Physicians; http://pier.acponline.org/index.html)

Proprietary Point-of-care database available online and as a mobile app.

CINAHL: Cumulative Index to Nursing and Allied Health Literature (EBSCO; https://health.ebsco.com/subjects/allied-health- nursing)

Proprietary Nursing and allied health bibliographic database. Mobile app available.

Cochrane Library (Wiley; http://www.thecochranelibrary.com/)

Proprietary Includes the Cochrane Database of Systematic Reviews (CDSR), Cochrane Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), and other evidence-based databases.

Epocrates Rx (http://www.epocrates.com/) Free Point-of care drug database available as a mobile app and online.

ERIC: Educational Resources Information Center (U.S. Department of Education; http://eric.ed.gov)

Free Education bibliographic database.

EMBASE: Excerpta Medica Online (Elsevier; https://www.elsevier.com/solutions/embase- biomedical-research)

Proprietary Biomedical bibliographic database having considerable overlap with

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PubMed. Strength is in drug information; focus is somewhat more European than PubMed.

Google Scholar (http://scholar.google.com) Free Conducts citing-articles searches.

Grey Literature Reports (http://www.greylit.org) Free Gray (unpublished) literature such as government reports and white papers focusing on the health sciences.

Joanna Briggs Institute (http://www.joannabriggs.org)

Proprietary Based at the University of Adelaide in Australia, the Joanna Briggs Institute develops systematic reviews and other resources with evidence- based information, particularly for nursing.

Micromedex (Truven Health Analytics; http://www.micromedex.com/)

Proprietary Drug database used by pharmacists as well as other clinicians. Available online and as a mobile app.

National Guidelines Clearinghouse (AHRQ; http://www.guideline.gov)

Free Practice guidelines.

Natural Medicines Comprehensive Database (Therapeutic Research Faculty; http://naturaldatabase.therapeuticresearch.com/)

Proprietary Database of natural products searchable with brand names. Includes herbals and other supplements. Online and via mobile app.

Networked Digital Library of Theses and Dissertations (http://www.ndltd.org/)

Free Bibliographic database of dissertations and theses.

Nursing Best Practice Guidelines (http://rnao.ca/bpg)

Free Guidelines developed by theRegistered Nurses Association of Ontario (Canada).

PubMed (U.S. National Library of Medicine; http://www.pubmed.gov)

Free Biomedical bibliographic database with wide global reach. Mobile app available.

PsycINFO (American Psychological Association; http://www.apa.org/)

Proprietary Behavioral health, psychology, and psychiatry bibliographic database.

SCOPUS (Elsevier; Proprietary General science

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https://www.elsevier.com/solutions/scopus) bibliographic database. Conducts citing-articles searches.

Web of Science (Thomson Reuters; http://wokinfo.com/)

Proprietary General science and social science bibliographic database. Conducts citing- articles searches.

Another key resource is MEDLINE, a large biomedical database that is freely available through the National Library of Medicine’s PubMed portal as well as via other search interfaces such as Ovid and EBSCO. Additional relevant databases include the Cochrane Library—in particular, the CDSR and the Cochrane Register of Controlled Trials (CENTRAL). Health and Psychosocial Instruments (HaPI) is a unique bibliographic database of behavioral instruments and scales, while PsycINFO includes citations on behavioral medicine and mental health. Google Scholar is the academic database offered by Google.com and an inc