Journal Club

ashambcast

ResourceManualforNursingResearch_GeneratingandAssessingEvidenceforNursingPractice11thEdition.pdf

Home >Nursing homework help >Journal Club

fet

thePoint” http://thepoint.lww.com/activate

Resource Manual for Nursing Research:

Generating and Assessing Evidence for

Nursing Practice, 11th Edition Denise F. Polit, PhD, FAAN « Cheryl Tatano Beck, DNSc, CNM, FAAN

Go to thePoint for a helpful Toolkit of

resources for students!

Scratch Off Below

PolitRM11e

Note: Book cannot be returned once panel is scratched off.

&. Wolters Kluwer

Resource Manual for

Nursing Research GENERATING AND ASSESSING EVIDENCE FOR NURSING PRACTICE

ELEVENTH EDITION

Denise F. Polit, PhD, FAAN President

Humanalysis, Inc.

Saratoga Springs, New York, and

Adjunct Professor

Griffith University School of Nursing

Brisbane, Australia

(www.denisepolit.com)

Cheryl Tatano Beck, DNSc, CNM, FAAN Distinguished Professor

School of Nursing

University of Connecticut

Storrs, Connecticut

(=), Wolters Kluwer Philadelphia * Baltimore * New York * London

Buenos Aires * Hong Kong * Sydney » Tokyo

Vice President and Publisher: Julie K. Stegman

Director of Nursing Content Publishing: Renee Gagliardi

Acquisitions Editor: Mark Foss

Director of Product Development: Jennifer K. Forestieri

Senior Development Editor: Meredith L. Brittain

Editorial Coordinator: David Murphy

Marketing Manager: Brittany Clements

Editorial Assistant: Molly Kennedy

Design Coordinator: Stephen Druding

Art Director, Illustration: Jennifer Clements

Production Project Manager: Barton Dudlick

Manufacturing Coordinator: Stacie Gantz

Prepress Vendor: TNQ Technologies

Eleventh Edition

by J. B. Lippincott Company.

form or by any means, including as photocopies or scanned-in or other electronic copies, or utilized by any information

storage and retrieval system without written permission from the copyright owner, except for brief quotations embodied in

critical articles and reviews. Materials appearing in this book prepared by individuals as part of their official duties as US

government employees are not covered by the abovementioned copyright. To request permission, please contact Wolters

Kluwer at Two Commerce Square, 2001 Market Street, Philadelphia, PA 19103, via email at [email protected], or via

our website at shop.lww.com (products and services).

DF S/O EEA © 33 82.

Printed in China

Library of Congress Cataloging-in-Publication Data

ISBN-13: 978-1-975112-26-4

Cataloging in Publication data available on request from publisher.

This work is provided “as is,” and the publisher disclaims any and all warranties, express or implied, including any

warranties as to accuracy, comprehensiveness, or currency of the content of this work.

This work is no substitute for individual patient assessment based upon healthcare professionals’ examination of each

patient and consideration of, among other things, age, weight, gender, current or prior medical conditions, medication

history, laboratory data, and other factors unique to the patient. The publisher does not provide medical advice or

guidance, and this work is merely a reference tool. Healthcare professionals, and not the publisher, are solely

responsible for the use of this work including all medical judgments and for any resulting diagnosis and treatments.

Given continuous, rapid advances in medical science and health information, independent professional verification of

medical diagnoses, indications, appropriate pharmaceutical selections and dosages, and treatment options should be made, and healthcare professionals should consult a variety of sources. When prescribing medication, healthcare profes- sionals are advised to consult the product information sheet (the manufacturer’s package insert) accompanying each drug to verify, among other things, conditions of use, warnings, and side effects and identify any changes in dosage schedule or contraindications, particularly if the medication to be administered is new, infrequently used, or has a narrow thera- peutic range. To the maximum extent permitted under applicable law, no responsibility is assumed by the publisher for any injury and/or damage to persons or property, as a rnatter of products liability, negligence law or otherwise, or from any reference to or use by any person of this work.

shop.lww.com

ccso921

Preface

This Resource Manual for the 11th edition of Nursing Research: Generating and Assessing Evidence for Nursing Practice complements and strengthens the textbook in

important ways. The manual provides opportunities to reinforce the acquisition of basic research skills through systematic learning exercises. We have emphasized exercises that involve careful reading and critical appraisal of actual studies. Critical appraisal skills are increasingly important in an environment that promotes evidence-based nursing practice. Moreover, the ability to think critically about research decisions is fundamental to being able to design and plan one’s own study.

Full research reports and two grant applications are included in 16 appendices to this Resource Manual. These reports, which represent a rich array of research endeavors, form the basis for exercises in each chapter. There are reports of quantitative, qualita- tive, and mixed methods studies. The reports include an evidence-based practice project report, an instrument development paper, a quality improvement project paper, a meta- analysis, and a metasynthesis. We are particularly excited about being able to include a full grant application that was funded by the National Institute of Nursing Research

(NINR), together with the Study Section’s summary sheet. We firmly believe that noth-

ing is more illuminating than a good model when it comes to research communication. In this edition, we have also included segments from a more recent grant application funded by NINR, including reviewers’ comments.

An important feature of this Resource Manual is the online Toolkit, which offers important resources to beginning and advanced researchers. Our mission was to include easily adaptable tools for a broad range of research situations. In this edition, we have added many more resources for qualitative researchers and tools that can be used in quality improvement projects. In our own careers as researchers, we have found that adapting existing forms, figures, manuals, or protocols is far more efficient and productive than “starting from scratch.” By making these tools available as Word files, we have made it

possible for you to adapt tools to meet your specific needs, without the tedium of having to

retype basic information. We wish we had had this Toolkit in our early years as research- ers! We think seasoned researchers are likely to find parts of the Toolkit useful as well.

The Resource Manual consists of 33 chapters—one chapter corresponding to every chapter in the textbook. Each chapter has relevant resources and exercises. Answers to exercises for which there are objective answers are included at the back of the book in

Appendix P. Each of the 33 chapters consists of four components:

e A Crossword Puzzle. Terms and concepts presented in the textbook are reinforced in

an entertaining and challenging fashion through crossword puzzles.

the materials in the textbook.

iv Preface

¢ Application Exercises. These exercises are designed to help you read, comprehend,

and critically appraise nursing studies. These exercises focus on studies in the appen- dices and ask questions that are relevant to the content covered in the textbook. For most chapters, there are two sets of questions—QOuestions of Fact and Questions for Discussion. The Questions of Fact will help you to read the report and find specific types of information related to the content covered in the textbook. For these ques-

tions, there are usually “right” and “wrong” answers. For example, for the chapter on sampling, a question might ask: How many people participated in this study? The Questions for Discussion, by contrast, require an assessment of the merits of various features of the study. For example, a question might ask: Was there a sufficient num- ber of participants in this study? The second set of questions can serve as the basis for classroom discussions.

¢ Toolkit @. This resource, found online on http://thepoint.lww.com/Polit1 1eRM,

includes tools and resources that can save you time—and that will hopefully result in higher-quality tools than might otherwise have been the case. Each chapter has tools appropriate for the content covered in the textbook.

We hope that you will find these resources rewarding, enjoyable, and useful in your effort to develop and hone skills needed in critically appraising and conducting research.

Contents

PART 1

Foundations of Nursing Research and Evidence-Based Practice 1

1. Introduction to Nursing Research in an Evidence-Based Practice Environment 2

2 Evidence-Based Nursing: Translating Research Evidence Into Practice 8

3 Key Concepts and Steps in Qualitative and Quantitative Research 13

PART 2

Conceptualizing and Planning a Study

to Generate Evidence for Nursing 23

4 Research Problems, Research Questions, and Hypotheses 24

5 Literature Reviews: Finding and Critically Appraising Evidence 31

6 Theoretical Frameworks 38

7 Ethics in Nursing Research 44

8 Planning a Nursing Study 51

PART 3

Designing and Conducting Quantitative Studies to Generate Evidence for Nursing 57

9 Quantitative Research Design 58

10 Rigor and Validity in Quantitative Research 64

11. Specific Types of Quantitative Research 70

12 Quality Improvement and Improvement Science 75

13 Sampling in Quantitative Research 80

14 Data Collection in Quantitative Research 85

15 Measurement and Data Quality 92

16 Developing and Testing Self-Report Scales 98

17 Descriptive Statistics 104

18 Inferential Statistics 110

vi Contents

19 Multivariate Statistics - 118

20 Processes of Quantitative Data Analysis 124

21 Clinical Significance and Interpretation of Quantitative Results 129

PART 4

Designing and Conducting Qualitative

Studies to Generate Evidence for Nursing 135

22 Qualitative Research Design and Approaches 136

23 Sampling in Qualitative Research 142

24 Data Collection in Qualitative Research 147

25 Qualitative Data Analysis 153

26 Trustworthiness and Rigor in Qualitative Research 163

PART 5

Designing and Conducting Mixed Methods

Studies to Generate Evidence for Nursing 169

27 Basics of Mixed Methods Research 170

28 Developing Complex Nursing Interventions Using Mixed Methods Research Wa

29 Feasibility and Pilot Studies of Interventions Using Mixed Methods 183

PART 6

Building an Evidence Base for Nursing Practice 189

30 Systematic Reviews of Research Evidence 190

31 Applicability, Generalizability, and Relevance: Toward Practice-Based

Evidence ie

32 Disseminating Evidence: Reporting Research Findings 202

33. Writing Proposals to Generate Evidence 207

Appendix A: Achieving Drug and Alcohol Abstinence Among Recently Incarcerated Homeless Women 213

Appendix B: Infant Feeding Beliefs and Day-to-Day Feeding Practices

of NICU Nurses 232

Appendix C: A Nurse-Facilitated Depression Screening Program in an Army Primary Care Clinic 245

Appendix D: Translation and Validation of the Dietary Approaches to Stop Hypertension for Koreans Intervention 258

Appendix E: Sharing a Traumatic Event 273

Contents

Appendix F: Fatigue in the Presence of Coronary Heart Disease

Appendix G: Care Transition Experience of Spousal Caregivers

Appendix H: A Randomized Controlled Trial of an Individualized

Preoperative Education Intervention for Symptom Management

After Total Knee Arthroplasty

*Critical Appraisal of the Study

Appendix I: Differences in Perceptions of the Diagnosis and

Treatment of Obstructive Sleep Apnea and Continuous Positive

Airway Pressure Therapy Among Adherers and Nonadherers

*Critical Appraisal of the Study

Appendix J: The Cancer Worry Scale Revised for Breast Cancer

Genetic Counseling

Appendix K: Medication Adherence Interventions, Patients With Cad

Appendix L: A Metaethnography of Traumatic Childbirth and Its Aftermath

Appendix M: Increasing Colorectal Cancer Screening Using

A Qi Approach

Appendix N: Health Care Practitioner Pain Communication:

R21 Grant Application

Appendix O: Multi-Omics Analysis: R01 Grant Application

Appendix P: Answers to Selected Resource Manual Exercises

Vii

284

300

322

337

344

370

377

391

406

420

431

472

479

Digitized by the Internet Archive

in 2024

https://archive.org/details/resourcemanualfoO000poli_x707

Foundations of

Nursing Research

and Evidence-Based

Practice

CHAPTER 1

Introduction to Nursing Research

in an Evidence-Based Practice

Environment

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 1. (Puzzles may be removed for easier viewing.)

. . |

oo 1

aE ae

BEER “pealaleds Ee

R rey : _

n x1 oy

nN N |

v : iN -

CHAPTER 1 = Introduction to Nursing Research in an Evidence-Based Practice 3

Note that there is a crossword puzzle in all chapters of this Resource Manual. We hope they will be a “fun” way for you to review key terms used in each chapter. However, we are not professional puzzle designers, and so there are some oddities about the puzzles. These oddities are not intended to be trick questions, but rather represent liberties we took in trying to get as many terms as possible into the puzzle. So, for example, there are a lot of acronyms (e.g., evidence-based practice = EBP) and abbreviations (e.g., evidence = evid) and even a few words that are written back- wards (e.g., evidence = ecnedive). Two-word answers sometimes appear with a space

(e.g., evidence-based), and sometimes they are just run together (e.g., evidencebased). The crossword puzzle answers are at the back of this Resource Manual, in case our intent is too obscure!

ACROSS

1. Nurses are increasingly encouraged to develop a practice that is (hyphenated).

3. The clinical learning strategy developed at the McMaster School of Medicine (acronym).

4. A world view, a way of looking at natural phenomena. 7, _____ ematic reviews are said to be the cornerstone of EBP because they integrate

research evidence on a research question. 10. The world view that assumes that there is an orderly reality that can be studied

objectively. 12. Studies designed to illuminate the underlying causes of phenomena are called

auise- phe aie cric inquiries.

13. Successively trying alternative solutions is known as and error. 14. Research designed to solve a practical problem is__ _ _ ied research. 15. Nurses who use evidence-based practice in making clinical decisions tend not to be

content with the status __. 17. Research designed to provide evidence to guide nursing practice is referred to as _ _

____al nursing research.

TS Oneontne mo ations of health care studies, regardless of paradigm, is that they often tend to be fallible.

19. The U.S. agency, which came into being in 1993, that promotes and sponsors nursing

research (acronym).

21. A source of “evidence” reflecting ingrained customs. 23. Studies that are designed to provide evidence about the effectiveness of health care

interventions fall within the EBP purpose category called ‘ 27. The Institute for Medicine’s (2010) report on The Future of Nursing recommended

qoreater ceeree Ol a ciplinary collaboration.

28. methods research involves the collection and analysis of both qualita-

tive and quantitative data.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

4 PART 1 = Foundations of Nursing Research and Evidence-Based Practice

DOWN

25;

26r

. One system of classifying research purposes concerns the description/

. Evidence that is rooted in objective reality and gathered through the senses.

. The positivist assumption that phenomena are not random, but rather have antecedent

causes. The repeating of a study to see if findings can be upheld in a new setting with a

different group of people. . A purpose of doing research, involving a depiction of phenomena (e.g., their preva-

lence or nature). . An EBP-related purpose of doing research, concerning the rigorous development of

health-related instruments.

continuum.

. The techniques used by researchers to guide or structure a study are called research

_ ods.

. The type of research that collects and analyzes narrative, subjective materials is__ _

_ _ ative research.

. In the constructivist paradigm, researchers tend to use , evolving proce-

dures that are used to address emerging findings. . Constructivist inquiry typically takes place in the , that is, in naturalistic

settings.

. One EBP-related purposes of health care research is to discover me___ _ from

clients’ perspectives and to understand processes in important health care transitions.

. One of the EBP-related purposes concerns the etiology of health risks, geared to the prevention of

A ____ucer of nursing research is a person who conducts a study to develop new evidence.

A(n) __ _ umption is a basic principle that is believed to be true without proof.

= B. Study Questions

ile

2] a.

Why is it important for nurses who will never conduct their own research to under- stand research methods?

What are some potential consequences to the nursing profession if nurses stopped conducting their own research?

What are some of the current changes occurring in the health care delivery system, and how could these changes influence nursing research and the use of research findings?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 1 a ~~ Introduction to Nursing Research in an Evidence-Based Practice 5

. Below are descriptions of several research problems. Indicate whether you think the problem is best suited to a qualitative or quantitative approach and explain your rationale.

a. What is the decision-making process of patients with prostate cancer who are weighing treatment options?

b. What effect does room temperature have on the colonization rate of bacteria in urinary catheters?

c. What are the perceptions of a healthy family among political refugees who immi- grate to North America?

d. Does therapeutic touch affect the vital signs of hospitalized patients? e. What is the meaning of hope among stage IV cancer patients? f. What are the effects of prenatal instruction on the labor and delivery outcomes of

pregnant women?

8. What are the experiences of the homeless living in cold climates in the winter?

. What are some of the limitations of quantitative research? What are some of the limitations of qualitative research? Which approach seems best suited to address problems in which you might be interested? Why is that?

. Scan through the titles in the table of contents of a recent issue of a nursing research journal (e.g., Nursing Research, Research in Nursing & Health, International Journal of Nursing Studies). Find the title of a study that you think is basic research and another that you think is applied research. Read the abstracts for these studies to see if you can determine whether your original supposition was correct.

. Apply the questions from Box 1.1 of the textbook (available as a Word document in the Toolkit @ on thePoint’ ) to one or more of the following studies. They are

available as open-access journal articles, and links to them are available in the

Toolkit @ :

e Dosani, A.; Hemraj, J.; Premji, S., Currie, G., Reilly, S-; Lodha;“A’, Hall; M.-..

(2017). Breastfeeding the late preterm infant: Experiences of mothers and perceptions of public health nurses. International Breastfeeding Journal,

roe e Holmberg Fagerlund, B., Helseth, S., Andersen, L., Smastuen, M., & Glavin, K.

(2018). Parental concerns of allergy or hypersensitivity and the infant’s diet.

Nursing Open, 6, 136-143. e Ullgren, H., Kirkpatrick, L., Kilpelainen, S., & Sharp, L. (2017). Working in

silos? Health & neck cancer patients during and after treatment with or with-

out early palliative care referral. European Journal of Oncology Nursing, 26,

56-62.

. Consider the nursing research priorities promoted by the National Institute of Nursing

Research, as identified in the textbook. Which priority resonates with you? Why?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

6 PART 1 = Foundations of Nursing Research and Evidence-Based Practice

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

Read the abstract and introduction to the report by Nyamathi and colleagues — . (“Achieving drug and alcohol abstinence”) in Appendix A. Then answer the following

questions:

Questions of Fact

a. Does this report describe an example of “disciplined research”?

b. Is this a qualitative or quantitative study? c. What is the underlying paradigm of the study? d. Does the study involve the collection of empirical evidence? e. Is this study applied or basic research? f. Could this study be described as cause probing? g. Is the purpose of this study identification, description, exploration, prediction/control,

and (or) explanation?

h. What is the EBP-focused purpose of this study (e.g., Therapy/intervention, Diagnosis, Prognosis, Etiology/harm, or Meaning/process)?

Questions for Discussion

a. How relevant is this study to the actual practice of nursing? b. Could this study have been conducted as either a quantitative or qualitative study?

Why or why not?

EXERCISE 2: STUDY IN APPENDIX B

Read the abstract and introduction to the report by Cricco-Lizza (“Infant feeding beliefs”) in Appendix B. Then answer the following questions:

Questions of Fact

a. Does this report describe an example of “disciplined research” ? b. Is this a qualitative or quantitative study?

c. What is the underlying paradigm of the study? d. Does the study involve the collection of empirical evidence? e. Is this study applied or basic research?

f. Is the specific purpose of this study identification, description, exploration, explana- tion, and/or prediction and control?

g. Could the study be described as cause probing?

h. What is the EBP-focused purpose of this study (e.g., Therapy/intervention, Diagnosis, Prognosis, Etiology/harm, or Meaning/process) ?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 1 = Introduction to Nursing Research in an Evidence-Based Practice if

Questions for Discussion

a. How relevant is this study to the actual practice of nursing? b. Could this study have been conducted as either a quantitative or qualitative study?

Why or why not?

c. Which of the two studies cited in these exercises (the one in Appendix A or Appendix B) is of greater interest and/or relevance to you personally? Why?

= D. The Toolkit $4)

For Chapter 1, the Toolkit GY on thePoint’ contains a Word file with the following:

¢ Questions for a Preliminary Review of a Research Report (Box 1.1 of the textbook) e Links to useful websites for Chapter 1 e Links to relevant open-access journal articles for Chapter 1

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 2

Evidence-Based Nursing:

Translating Research Evidence

Into Practice

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 2. (Puzzles may be removed for easier viewing.)

w J

a _

— _ es i

, =. al bo

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 2 ™ Evidence-Based Nursing: Translating Research Evidence Into Practice 9

ACROSS

24.

The acronym used for well-worded clinical questions that do not involve a comparison.

Best-practice clinical clinical based on systematic reviews of evidence are important tools for evidence-based practice.

EBP are a resource to guide clinicians in planning and implementing an EBP project.

In the SA EBP scheme, step number 5S is to the outcomes of the practice change.

. Acronym describing main focus of the chapter.

. Some EBP models distinguish a knowledge-focused and problem-focused for an EBP effort.

. In a well-worded clinical question, the “O” component represents the

. A type of study that ranks high in many evidence hierarchies as an evidence source for Therapy questions (acronym).

. Evidence hierarchies are associated with __ scales for ranking evidence sources for the risk of bias (acronym, spelled backward).

. In appraisals of research evidence, one of the criteria concerns the of the evidence for particular settings and patients.

translation is a term related to EBP that is often associated with efforts to enhance systematic change in clinical practice.

. Some well-worded clinical questions include a “T” component, which represents

In a well-worded clinical question, the “I” component represents the on 5)

or influence on an outcome.

DOWN

lee Lie hierarchy is a guide to evidence retrieval, ranging from Systems at the pinnacle and single studies at the base.

2. A meta is a statistical method of combining evidence in a systematic

review. 3. Resources for EBP include various types of evidence that has been by

experts. 4. The widely-used system for evaluating evidence involves grading the

quality of an overall body of evidence and a ranking of the strength of recommenda-

tions based on the evidence. In a well-worded clinical question, the “C” component represents the

A level of evidence can be used to rank evidence sources in terms of their

risk of bias. reviews of RCTs are at the pinnacle of most evidence hierarchies for

Therapy questions.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

10 PART 1 = Foundations of Nursing Research and Evidence-Based Practice

In appraisals of research evidence, one of the criteria concerns the _______ de of

the effect of the influence on the outcome on O, that is, how pewerful the effect is.

. Acronym for the EBP model proposed by Melnyk and Fineout-Overholt proposed

the _— _ -E model of EBP (acronym).

. Ina well-worded clinical question, the “P” component represents the

. The definition of evidence-based practice includes three components, one of which is nurses’ own clinical se.

. Acronym for a four-component scheme for asking well-worded questions for an EBP

inquiry.

. In the five-step (SA) EBP process, the first step is _ :

. Evidence based practice involves the conscientious integration of current evidence in clinical decision-making.

= B. Study Questions

al For each of the following research questions, identify the component that is under-

lined as either the P, I, C, or O component.

a. Among community-dwelling elders, does fear of falling affect their quality of life?

b. Does amount of social support among women with multiple sclerosis affect dis- ability to a greater degree than illness duration?

c. Among children of age 5-10 years, does participation in the XYZ Youth Fitness Initiative result in better cardiovascular fitness than participation in routine school play activities?

d. Does chronic stress contribute to fatigue among patients with a traumatic head injury?

e. Among older adults in a long-term care setting, does a reminiscence program reduce depressive symptoms?

f. Among methadone-maintenance therapy clients, are men more likely than women to be heavy cigarette smokers?

g. Does family involvement in diabetes management affect glucose control among immigrants with type 2 diabetes?

h. Among hospitalized adult patients, is greater nurse staffing levels associated with shorter lengths of hospital stay?

i. Is music more effective treatment than guided imagery in reducing pain in women in labor?

j. Does self-concept affect dietary intake in moderately obese adults?

. Identify the factors in your own practice setting that you think facilitate or inhibit research utilization and evidence-based practice (or, in an educational setting, the factors that promote or inhibit a climate in which EBP is valued). For any barriers, what steps might be taken to address those barriers?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 2 ® Evidence-Based Nursing: Translating Research Evidence Into Practice 11

3. Think about a nursing procedure that you have learned. What is the basis for this procedure? Determine whether the procedure is based on scientific evidence indicat- ing that the procedure is effective. If it is not based on scientific evidence, on what is it based, and why do you think scientific evidence was not used?

4. Read one of the following articles and identify the steps of the lowa model (or an alternative model of EBP) that are represented in the EBP project described.

e *Blair, K., Eccleston, S., Binder, H., & McCarthy, M. (2017). Improving the

patient experience by implementing an ICU diary for those at risk of post- intensive care syndrome. Journal of Patient Experience, 4, 4-9.

¢ Lemus, L., McMullin, B., & Balinowski, H. (2018). Don’t ignore my snore:

Reducing perioperative complications of obstructive sleep apnea. Journal of Perianesthesia Nursing, 33, 338-345.

¢ Wonder, A., Martin, E., & Jackson, K. (2017). Supporting and empowering direct-

care nurses to promote EBP: An example of evidence-based policy development, edu- cation, and practice change. Worldviews on Evidence-Based Nursing, 14, 336-338.

5. Read the following open-access article (a link to which is in the Toolkit G9) and comment on the diligence with which the WOCN task force developed its algorithm relating to venous leg ulcers:

e *Ratliffe, C., Yates, S., McNichol, L., & Gray, M. (2016). Compression for pri-

mary prevention, treatment, and prevention of recurrence of venous leg ulcers: An evidence-and consensus-based algorithm for care across the continuum. Journal of Wound, Ostomy, and Continence Nursing, 43, 347-364.

6. Compare the revised lowa Model, as described in the textbook (Figure 2.3) to an alternative model of evidence-based practice (e.g., one listed in Box 2.1). What are

the main areas of similarity and difference in the models? Which model do you think would work best in your setting?

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX C

Read the abstract and introduction to the report by Yackel and colleagues (“Nurse-

facilitated depression screening program”) in Appendix C. Then answer the following

questions:

Questions of Fact

. What was the purpose of this EBP project?

. What was the setting for implementing this project?

. Which EBP model was used as a framework for this project?

. Did the project have a problem-focused or a knowledge-focused trigger? (ek ey lop

* An open-access journal article; a link is provided in the Toolkit € for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

12 PART 1. ® Foundations of Nursing Research and Evidence-Based Practice

. Who were the team members in this study, and what were their affiliations?

. What, if anything, did the report say about the implementation petential of this project?

. Was a pilot study undertaken?

. Did this project involve an evaluation of the project’s success? = 09 sy oO

Questions for Discussion

a. What might be a clinical foreground question that was used in seeking relevant evidence in preparing for this project? Identify the PIO or PICO components of your question.

b. What are some of the praiseworthy aspects of this project? What could the team

members have done differently to improve the project?

EXERCISE 2: STUDY IN APPENDIX K

Read the abstract and introduction (from the beginning to the “Methods” section) of the report by Chase and colleagues (“Medication adherence interventions”) in Appendix K.

Then answer the following questions:

Questions of Fact

a. Does this report summarize a systematic review? If yes, was a meta-analysis performed?

b. Is this an example of pre-appraised evidence? At which level on the 6S hierarchy

(Table 2.1 of the textbook) does this work belong? c. Where on the evidence hierarchy for Therapy questions shown in Figure 2.2 of the

textbook would this study belong? d. What is the stated purpose of this study?

Questions for Discussion

a. What might be the clinical foreground question that guided this study? Identify the PICO components of the question.

b. What are some of the steps would you need to undertake if you were interested in using this study as a basis for an EBP project in your own practice setting?

= D. The Toolkit 54)

For Chapter 2, the Toolkit @ on thePoint’ contains the following:

¢ Selected Definitions of “Evidence-Based Practice” e The 6S Hierarchy of Evidence Sources (Table 2.1 of the textbook) ¢ Selected Evidence Hierarchies/Level of Evidence Scales

¢ Question Templates for Selected Clinical Foreground Questions (based on Table 2.2 of the textbook)

¢ Worksheet: Questions for Appraising the Evidence for EBP e Links to useful websites for Chapter 2 e Links to relevant open-access journal articles for Chapter 2

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 3

Key Concepts and Steps in

Qualitative and Quantitative

Research

& A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 3. (Puzzles may be removed for easier viewing.)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

14 PART1 ™® Foundations of Nursing Research and Evidence-Based Practice

ACROSS

2. Another name for outcome variable is variable.

6. An individual with whom a researcher must negotiate to gain entrée into a site.

8. Two operationalizations of weight involve the pound system and the ____ system. 10. A step in experimental research involves developing an intervention 11. In “What is the effect of radon on lung cancer incidence?” the independent eral

is 13. If the eeraciicy of a statistical test were < .001, the results would be highly __ _ _

micant. 15. Pieces of information gathered in a study. 16. Data that are in the same form as when they were collected are data. 18. The definition indicates how a variable will be measured or

observed. 19. A variable that has only two values or categories (e.g., alive/dead) is__ _ _

otomous. 21. A systematic, abstract explanation of phenomena (first and last letter). DD _ ical fieldwork may be needed in preparing for a study, to enhance the study’s

value for practicing nurses. 24, ie ical tests are used by quantitative researchers to assess the reliability of

their results. 26, One ” offered in the textbook was to always select a research problem in

S10) oo. 34. 36: o/s 38:

which there is a strong personal interest. . Some qualitative researchers do not undertake an upfront __ _ erature review, so as

to avoid having their conceptualization influenced by the work of others. The type of design used in qualitative studies. A bond or connection between phenomena (first two letters).

The type of research design used to test the effects of an intervention. Terminology that often makes research reports difficult to read. A research investigation.

A(n) __ _ experimental study is sometimes called an observational study.

DOWN

. The qualitative tradition that focuses on the study of cultures is _ | graphy.

ies)

The qualitative research tradition that focuses on lived experiences is _ _ omenology.

The independent variable in: “What is the effect of diet on risk of cancer?”

A sampling in a quantitative study indicates how participants will be sampled, and how many will be needed.

= Data is a principle used to decide when to stop sampling in a qualita- tive study.

. The entire aggregate of units in which a researcher is interested.

. A qualitative tradition that focuses on social psychological processes within a social setting is theory.

. Quantitative researchers formulate

CHAPTER3 ® Key Concepts and Steps in Qualitative and Quantitative Research 15

. A somewhat more complex abstraction than a concept.

. If the independent variable is the cause, the dependent variable is the

. The variable that is hypothesized to be the cause of another variable (acronym).

. A(n) variable has a finite number of values between two points

(e.g., number of children).

. A relationship in which one variable directly changes the value of another is a relationship.

eses, which state expectations about how variables are related.

. Quantitative researchers develop a knowledge context by doing a review early in the project (abbr.).

. The first in a project involves formulating a research problem.

. In quantitative studies, the data collection plan specifies the location and of gathering the data, as well as which measurements will be made.

. The format used to structure most research reports (acronym).

. In finalizing a research plan, it is wise to have proposed methods reviewed by an advisor, a (such as a colleague), or a research consultant.

. A(n) sample is one that is representative of the population of interest.

. Quantitative researchers use a statistical to analyze their data and assess whether their hypotheses are supported.

. A relationship expresses a bond between at least variables.

= B. Study Questions

ule Suggest operational definitions for the following concepts.

SIOULESS: . Prematurity of infants:

. Fatigue:

Pain:

Obesity: Prolonged labor: Smoking behavior: Sas gy ed see i 9 She

. In each of the following research questions, identify the independent and dependent

variables.

a. Does assertiveness training improve the effectiveness of psychiatric nurses?

Independent:

Dependent:

b. Does the postural positioning of patients affect their respiratory function?

Independent:

Dependent:

Generating and Assessing Evidence for Nursing Practice (11th ed.)

16 PART 1 ® Foundations of Nursing Research and Evidence-Based Practice

_ Is patients’ anxiety affected by the amount of touch received from nursing staff?

Independent: Zi Dependent:

(eo)

d. Is the incidence of decubitus reduced by more frequent turnings of patients?

Independent:

Dependent:

. Are people who were abused as children more likely than others to abuse their

own children? Independent: Dependent:

f. Is tolerance for pain related to a patient’s age and gender?

Independent: Dependent:

g. Is the number of prenatal visits of pregnant women associated with labor and

delivery outcomes? Independent: Dependent:

h. Are levels of depression higher among children with a chronic illness than among

other children? Independent: Dependent:

i. Is compliance with a medical regimen higher among women than among men? Independent: Dependent:

j. Does participating in a support group enhance coping among family caregivers of AIDS patients?

Independent: Dependent:

k. Is hearing acuity of the elderly different at different times of day? Independent: Dependent:

1. Does home birth (versus hospital birth) affect the parents’ satisfaction with the childbirth experience? Independent: Dependent:

m. Does a neutropenic diet in the outpatient setting decrease the positive blood cul- tures associated with chemotherapy-induced neutropenia? Independent: Dependent:

CHAPTER3 ™& Key Concepts and Steps in Qualitative and Quantitative Research 17

3. Below is a list of variables. For each, think of a research question for which the variable would be the independent variable and a second for which it would be the dependent variable. For example, take the variable “birth weight of infants.” We might ask, “Does the age of the mother affect the birth weight of her infant?” (birth weight is the dependent variable). Alternatively, our research question might be, “Does the birth weight of infants (independent variable) affect their sensorimotor development at 6 months of age?” HINT: For the dependent variable problem, ask yourself, What factors might affect, influence, or cause this variable? For the inde-

pendent variable, ask yourself, What factors does this variable influence, cause, or affect?

a. Body temperature Independent: Dependent:

b. Amount of sleep Independent: Dependent:

c. Frequency of practicing breast self-examination Independent: Dependent:

d. Level of hopefulness in cancer patients Independent: Dependent:

e. Stress among victims of domestic violence Independent: Dependent:

4. Look at the table of contents of a recent issue of Nursing Research, Journal of Advanced Nursing, or Research in Nursing & Health (or another research-focused nursing journal). Pick out a study title (not looking at the abstract) that implies that a relationship between variables was scrutinized. Indicate what you think the independent and dependent variable might be, and what the title suggests about the nature of the relationship (i.e., causal or not).

5. Describe what is wrong with the following statements:

a. Lanza’s experimental study was conducted within the ethnographic tradition. b. Mallory’s experimental study examined the effect of relaxation therapy (the

dependent variable) on pain (the independent variable) in cancer patients.

c. In her grounded theory study of the caregiving process for caregivers of patients with dementia, Chisolm explored the lived experience of the caregivers.

d. In Evans’ phenomenological study of the meaning of futility among AIDS patients, subjects received an intervention designed to sustain hope.

e. In her experimental study, Rusch developed her data collection plan after she introduced her intervention to a group of patients.

18 PART1 ® Foundations of Nursing Research and Evidence-Based Practice

6. Read one of the following reports of a qualitative study and identify segments of

raw data: i

e Siler S., Mamier I., Winslow B., & Ferrell B. (2019). Interprofessional perspec-

tives on providing spiritual care for patients with lung cancer in outpatient set- tings. Oncology Nursing Forum, 46, 49-S8.

e *Wazgar D. (2018). Oncology nurses’ perceptions of work stress and its sources in a university-teaching hospital: A qualitative study. Nursing Open, 6, 100-108.

What effect would the removal of the raw data have on the quality of the report?

7. Apply the questions from Box 3.3 of the textbook (available as a Word document in

the Toolkit G9 on thePoint’) to one of the following studies:

e *Blaser R., & Berset J. (2018). Setting matters: Associations of nurses’ attitudes

toward people with dementia. Nursing Open, 6, 155-161. e *Kim M., Lim N., Kim H., Kim C., & Lee J. (2018). Pediatric deaths

attributed to complex chronic conditions over 10 years in Korea: Evidence for the need to provide pediatric palliative care. Journal of Korean Medical

Science, 33, e1.

¢ Nelson-Brantley H., Park S., & Bergquist-Beringer S. (2018). Characteristics of

the nursing practice environment associated with lower unit-level RN turnover. Journal of Nursing Administration, 48, 31-37.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX D

Read the abstract and introduction (the material before “Methods”) to the report by Kim and colleagues (“Dietary approaches to stop hypertension”) in Appendix D. Then answer the following questions:

Questions of Fact

. Who were the lead researchers, and what are their credentials and affiliations?

. Did the researcher receive funding for this research? (See the first page.)

. Who were the study participants?

. What is the independent variable in this study? Is this variable inherently an indepen- dent variable?

e. What is the dependent/outcome variable (or variables) in this study? Is this variable inherently a dependent variable?

f. Did the introduction actually use the terms “independent variable” or “dependent variable?”

g. Were the data in this study quantitative or qualitative?

fox. () ler i)

*A link to this open access journal article is provided on the Toolkit GY for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER3 ™ Key Concepts and Steps in Qualitative and Quantitative Research

Were any relationships under investigation? What type of relationship? . Is this an experimental or nonexperimental study? Did the study involve an intervention? If so, what is it? Did the study involve statistical analysis of data? Did it involve the qualitative analysis of data? Does the report follow the IMRAD format?

Questions for Discussion

. How relevant is this study to the actual practice of nursing?

. Could this study have been conducted as either a quantitative or qualitative study? Why or why not?

. How good a job did the researchers do in summarizing their study in the abstract?

. How long do you estimate it took for this study to be completed?

EXERCISE 2: STUDY IN APPENDIX E

Read the abstract and introduction to the report by Cummings (“Sharing a Traumatic Event”) in Appendix E. (This study is about the airplane crash in the Hudson River, New York, that was dramatized in the 2016 movie Scully.) Then answer the following

questions:

Questions of Fact

a 9 ES), NOR Ko. Lom ich)

—-

. Who was the researcher and what are her credentials and affiliation?

. Did the researcher receive funding for this research? (See last page of article.)

. Who were the study participants?

. In what type of setting did the study take place?

. What was the key concept in this study?

. Were there any independent variables or dependent variables in this study? Were the data in this study quantitative or qualitative?

. Were any relationships under investigation? Could the study be described as an ethnographic, phenomenologic, or grounded theory

study? Is this an experimental or nonexperimental study? Did the study involve an intervention? If so, what is it? Did the study involve statistical analysis of data? Did the study involve qualitative

analysis of data? m. Does the report follow the IMRAD format?

Questions for Discussion

b. How relevant is this study to the actual practice of nursing?

Could this study have been conducted as either a quantitative or qualitative study?

Why or why not?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

20 PART 1 = Foundations of Nursing Research and Evidence-Based Practice

c. How good a job did the researcher do in summarizing her study in the abstract?

d. How long do you estimate it took for this study to be completed?

e. Which of the two studies cited in these exercises (the one in Appendix E or Appendix D)

is of greater interest and/or relevance to you personally? Why?

EXERCISE 3: TRANSLATION EXERCISE

Below is an example of summary of a fictitious study, written in the style typically found

in research journal articles. Terms that can be looked up in the glossary of the text- book are underlined. Then, a “translation” of this summary is presented, recasting the research information into language that is more informal. Study this example and then use it as a model for “translating” the abstracts of one of the studies in the appendices of

this book.

Summary of Fictitious Study

The potentially negative sequelae of having an abortion on the psychological adjustment of adolescents have not been adequately studied. The present study sought to explore

whether alternative pregnancy resolution decisions have different long-term effects on

the psychological functioning of young women. Three groups of low-income pregnant teenagers attending an inner-city clinic were

the subjects in this study: Those who delivered and kept the baby; those who deliv- ered and relinquished the baby for adoption; and those who had an abortion. There

were 25 subjects in each group. The study instruments included a self-administered questionnaire and a battery of psychological tests measuring depression, anxiety, and

psychosomatic symptoms. The instruments were administered upon entry into the study (when the subjects first came to the clinic) and then 1 year after termination of the pregnancy.

The data were analyzed using analysis of variance (ANOVA). The ANOVA tests indi- cated that the three groups did not differ significantly in terms of depression, anxiety, or psychosomatic symptoms at the initial testing. At the posttest, however, the abor- tion group had significantly higher scores on the depression scale, and these girls were

significantly more likely than the two delivery groups to report severe tension headaches. There were no significant differences on any of the dependent variables for the two deliv- ery groups.

The results of this study suggest that young women who elect to have an abortion

may experience a number of long-term negative consequences. It would appear that appropriate efforts should be made to follow-up abortion patients to assess their need for suitable intervention.

Translated Version

As researchers, we wondered whether young women who had an abortion had any emo- tional problems in the long run. It seemed to us that not enough research had been done to know whether any psychological harm resulted from an abortion.

CHAPTER3 ™& Key Concepts and Steps in Qualitative and Quantitative Research 21

We decided to study this question ourselves by comparing the experiences of three types of teenagers who became pregnant—first, girls who delivered and kept their babies; second, those who delivered the babies but gave them up for adoption; and third, those who elected to have an abortion. All teenagers in the sample were poor, and all were patients at an inner-city clinic. Altogether, we studied 75 girls—25 in each of the three groups. We evaluated the teenagers’ emotional states by asking them to fill out a questionnaire and to take several psychological tests. These tests allowed us to assess things such as the girls’ degree of depression and anxiety and whether they had any com- plaints of a psychosomatic nature. We asked them to fill out the forms twice: once when they came into the clinic and then again a year after the abortion or the delivery.

We learned that the three groups of teenagers looked pretty much alike in terms of their emotional status when they first filled out the forms. But when we compared how the three groups looked a year later, we found that the teenagers who had had an abortion were more depressed and were significantly more likely to say they had severe tension headaches than teenagers in the other two groups. The teenagers who kept their babies and those who gave their babies up for adoption looked pretty similar 1 year after their babies were born, at least in terms of depression, anxiety, and psychosomatic complaints.

Thus, it seems that we might be right in having some concerns about the emotional effects of having an abortion. Nurses should be aware of these long-term emotional effects, and it even may be advisable to institute some type of follow-up procedure to find out if these young women need additional support.

= D. The Toolkit €3

For Chapter 3, the Toolkit 9 on thePoint’ contains a Word file with the following:

¢ Overview of the SQ3R Reading Technique e Additional Questions for a Preliminary Review of a Study (Box 3.3 of the textbook) e Links to useful websites for Chapter 3 e Links to relevant open-access journal articles for Chapter 3

Generating and Assessing Evidence for Nursing Practice (11th ed.)

~ 1 = ‘

ip wa ; ih a On a % 7

i aden ni:

ee — THON ail es

dha reeag WAM apys ite : Spon uh ere linwly fas

Vet i Ria ety guys, ee a

mat irre 4 Ore? af te pian inhi rw ee ee a is:

_ Wrmveleted Version

ay vengegees. de 5 on ficsinal evestlgine Bie “aE re. 5 ii es wise ay Kom! ‘

se - i a =

‘

Rae ee es (um ght hae

Conceptualizing and Planning a Study to

Generate Evidence for Nursing

CHAPTER 4 ~

Research Problems, Research

Questions, and Hypotheses

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 4. (Puzzles may be removed for easier viewing.)

CHAPTER4 ™ Research Problems, Research Questions, and Hypotheses 25

ACROSS

6. A hypothesis in which the specific nature of the predicted relationship is not stipulated.

9. A statement of purpose in a quantitative study indicates the key study variables and the __ _ ulation of interest.

10. Researchers express the disturbing situation in need of investigation in their problem

11. A hypothesis stipulates the expected relationship between a(n) ___ and a DV (abbr.). 12. One phrase that indicates the relational aspect of a hypothesis is ____ than. 14. One aspect of a problem statement concerns the of the problem (e.g., how

many people are affected?). 18. One source of research problems, especially for hypothesis-testing research. 19. A hypothesis with two or more independent and/or dependent variables—the oppo-

site of a simple hypothesis. 21. The results of hypothesis testing never constitute that the hypotheses are or

are not correct. 23. The purpose of a study is often conveyed through the judicious choice of 24. A hypothesis must always involve at least variables. 25. In the question, “What is the effect of daily exercise on mood and weight?”, mood

and weight are the (acronym). 26. A statement of purpose indicating that the intent of the study was to prove or

demonstrate something suggests a ,

27. A research is what researchers wish to answer through systematic

study.

DOWN

1. A hypothesis with one independent and one dependent variable. 2. The actual hypothesis of an investigator is the _ _ _ earch hypothesis. 3. Another name for null hypothesis. 4. A practical consideration in assessing feasibility concerns the ___ of undertaking

the study. 5. Hypothesis involves the use of statistical analyses that assess the proba-

bility of a hypothesis being correct. 6. The hypothesis that posits no relationship between variables.

7. The independent variable in the research question, “Does a nap improve evening

mood state in the elderly?”. 8. An intention of what to accomplish in a study.

13. The researcher’s overall goals of undertaking a study.

15. A statement of the researcher’s prediction about associations between variables is

a(n) _ _ _ othesis.

16. In terms of timing, the study hypotheses should be stated collecting the

research data.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

18.

20.

PART2 ®& Conceptualizing and Planning a Study to Generate Evidence for Nursing

ship between the independent and depen- ~

Hypotheses must predict a dent variables. In terms of feasibility of addressing a problem, is almost always an issue

because researchers usually have scheduling deadlines. A __ statement is a declaration that summarizes the general direction

of the inquiry. A research _ _ _ lem is an enigmatic or troubling condition.

= B. Study Questions

ile Below is a list of topics that could be the focus of a research inquiry. Develop at least one research question for each, making sure that some questions could be addressed through qualitative research and others could be addressed through quan- titative research. It will likely be helpful to use the question template in the accom- panying Toolkit @ . (HINT: For quantitative research questions, think of these concepts as potential independent or dependent variables, then ask, “What might

cause or affect this variable?” and “What might be the consequences or effects of this variable?” This should lead to some ideas for research questions.)

Patient comfort Psychiatric patients’ readmission rates Anxiety in hospitalized children Elevated blood pressure Incidence of sexually transmitted diseases (STDs)

Patient cooperativeness in the recovery room

Caregiver stress

Mother-infant bonding Menstrual irregularities as Om eG) a

—_—

. Below are five nondirectional hypotheses. Restate each one as a directional hypothe- sis (you may have to simply “make up” your own hypothesis).

Nondirectional Directional

a. Tactile stimulation is associated with comparable physiological arousal as verbal stimulation among infants with congenital heart disease.

b. The risk of hypoglycemia in term newborns is related to the infant’s birthweight.

c. The use of isotonic sodium chloride solution before endotracheal suctioning is related to oxygen saturation.

d. Fluid balance is associated with degree of success in weaning older adults from mechanical ventilation.

e. Nurses administer the same amount of narcotic analgesics to male and female patients.

CHAPTER 4 © Research Problems, Research Questions, and Hypotheses 27

3. Below are five simple hypotheses, with one dependent variable and one independent variable. Change each one to a complex hypothesis by adding either a dependent or independent variable, so that there are either two predicted “causes” of an outcome or two predicted “effects” of an independent variable.

Simple Hypothesis Compiex Hypothesis

a. First-time blood donors experience greater stress during the donation than donors who have given blood previously.

. Nurses who initiate more conversation with patients are rated as more effective in their nursing care by patients than those who initiate less conversation. Surgical patients who give high ratings to the infor- mativeness of nursing communications experience less preoperative stress than do patients who give low ratings. Residents in memory care facilities who have a weekly foot massage are less agitated than residents who do not receive a foot massage. Women who have a cesarean birth are more likely to experience postpartum depression than women who give birth vaginally.

. In study questions 2 and 3 above, 10 research hypotheses were provided. Identify the independent and dependent variables in each.

Independent Variable(s) Dependent Variable(s)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

PART2 = Conceptualizing and Planning a Study to Generate Evidence for Nursing

Below are five statements that are mot research hypotheses as currently stated.

Suggest modifications to these statements that would make them testable research

hypotheses.

Original Statement Hypothesis

a. Relaxation therapy is effective in reducing hypertension.

b. The use of bilingual health care staff produces high utilization rates of health care facilities by ethnic

minorities. c. Nursing students are affected in their choice of clini-

cal specialization by their family’s health history. d. Sexually active teenagers have a high rate of using

male methods of contraception. e. In-use intravenous solutions become contaminated

within 48 h.

. Examine a recent issue of a nursing research journal. Find an article that does not present a well-articulated statement of purpose. Write a statement of purpose for

that study.

. Read the introduction of one of the following reports. Use the critical appraisal guidelines in Box 4.3 of the textbook (available as a Word document in the Toolkit @ )

to assess the study’s problem statement, purpose statement, research questions, and/ or hypotheses:

¢ Corno, J. M. (2018). Health literacy and health status in people with chronic

heart failure. Clinical Nurse Specialist, 32, 29-42.

¢ *Hornik, B., Dulawa, J., Szewieczek, J., & Durmala, J. (2019). Physical activity

increases the resistin concentration in hemodialyzed patients without metabolic syndrome. Diabetes, Metabolic Syndrome and Obesity, 12, 43-57.

¢ McNiel, P., & Westphal, J. (2018). Namaste care: A person-centered care

approach for Alzheimer’s and advanced dementia. Western Journal of Nursing Research, 40, 37-51.

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX F

Read the abstract and introduction to the report by Eckhardt and colleagues (“Fatigue in coronary heart disease”) in Appendix F. Then answer the following questions:

*A link to this open-access journal article is provided on the Toolkit 9 for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 4 ™ Research Problems, Research Questions, and Hypotheses 29

Questions of Fact

a. In which paragraph(s) of this report is the research problem stated? b. Does this report present a statement of purpose? If so, what verb do the researchers use in

the statement, and is that verb consistent with the type of research that was undertaken? c. Does the report specify a research question? If so, was it well-stated? If not, indicate

what the question was.

d. Does the report specify hypotheses? If there are hypotheses, were they appropriately worded? Are they directional or nondirectional? Research or null?

e. If no hypotheses were stated, what would one be? f. Were hypotheses tested?

Questions for Discussion

a. Did the researchers do an adequate job of describing the research problem? Describe in 2-3 sentences what the problem is.

b. Comment on the significance of the study’s research problem for nursing. c. Did the researchers do an adequate job of explaining the study purpose, research

questions, and/or hypotheses?

EXERCISE 2: STUDY IN APPENDIX B

Read the abstract and introduction to the by Cricco-Lizza (“Infant feeding beliefs”) in Appendix B. Then answer the following questions:

Questions of Fact

a. In which paragraph(s) of this report is the research problem stated? b. Does this report present a statement of purpose? If so, what verb do the researchers

use in the statement, and is that verb consistent with the type of research that was undertaken?

c. Does the report specify a research question? If so, was it well-stated? If not, indicate

what the question was. d. Does the report specify hypotheses? If there are hypotheses, were they appropriately

worded? Are they directional or nondirectional? Research or null?

e. Were hypotheses tested? f. Is there any evidence that the problem for this study emerged as part of a program of

research?

Questions for Discussion

a. Did the researcher do an adequate job of describing the research problem? Describe in 2-3 sentences what the problem 1s.

b. Comment on the significance of the study’s research problem for nursing.

c. Did the researcher do an adequate job of explaining the study purpose, research ques-

tions, and/or hypotheses?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

30 PART 2 ® Conceptualizing and Planning a Study to Generate Evidence for Nursing

= D. The Toolkit ; 3

For Chapter 4, the Toolkit @ on thePoint’ contains a Word file with the following:

Research Question Templates for Selected Clinical Problems Worksheet: Key Components of a Problem Statement

Guidelines for Critically Appraising Research Problems, Research Questions, and Hypotheses (Box 4.3 of the textbook) Links to useful websites for Chapter 4 Links to relevant open-access journal articles for Chapter 4

CHAPTER 5

Literature Reviews: Finding and

Critically Appraising Evidence

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 5. (Puzzles may be removed for easier viewing.)

Lo | a . Fb

13 1

Cee i

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

32 PART2 © Conceptualizing and Planning a Study to Generate Evidence for Nursing

ACROSS

6. A good way to extract and organize information for a literature review is to use

two-dimensional or summary tables. 9. A(n) is a careful appraisal of the strengths and weaknesses of a

study. Ose approach is a search strategy that involves finding a pivotal

early study and then searching for subsequent citations to it. 11. A common abbreviation for “literature,” as ina __ _ review.

13. A very important bibliographic database for nursing and allied health professions. 16. A literature review typically involves a careful of an entire body

of research on a particular research question. 19. The MEDLINE database can be accessed for free through

20. A Boolean operator that expands a search. 21. Key citation information for a journal article includes the name of the journal, vol-

ume, and numbers.

22. A Boolean operator that should be used with caution. 23. If a researcher has been prominent on the topic of your review, it is useful to do a(n)

search in bibliographic databases. 24. In doing a computerized search, a match between a bibliographic entry and your

search criteria is sometimes called a “ z 25. In searches in bibliographic databases, one can search by keywords or by subject _ _

_ _ ngs that indexers use to code each record. 27. The standardized vocabulary used to index records in PubMed is called 28. Searching for relevant references on a topic is expedited through the use of a bib-

liographic ;

31. Descriptions of studies prepared by someone other than the investigators are sources.

COIN system that categorizes results in a systematic fashion is a good tool for organizing research results in a summary table.

DOWN

1. Qualitative researchers do not all agree about whether the should be reviewed before undertaking a study.

2. Acronym for a free bibliographic database that is sometimes used to search the literature.

3. Research reports with limited distribution are sometimes referred to as the literature.

. A major resource for finding research reports is __ _ _ iographic databases.

. In their reviews, reviewers should paraphrase and avoid a from another source if possible.

6. A very important bibliographic database for health care professionals. 7. After developing data extraction forms, they should be subjected to a pilot

to ensure that all key information will be recorded.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

hey

30.

CHAPTER 5 Literature Reviews: Finding and Critically Appraising Evidence 33

. One widely used reference manager software is called os - A mechanism through which computer software translates your topics into appro- priate subject terms for an electronic search of a bibliographic database.

. In doing a literature review, it is important to be well-organized and to maintain key files and folders on your computer or in the for easy retrieval.

. Literature searches can benefit from the assistance of a rian.

. When doing a database search, one often begins with one or more Sy

. In launching a search, it is beneficial to conceptualize key research S broadly, to avoid missing an important study.

. An upfront literature review may not be undertaken by researchers doing a study in the grounded tradition.

. Findings from a report written by researchers who conducted a study are a(n) source for a research review.

. If a journal is a(n) access journal, its articles are freely available to download. A search strategy sometimes called “footnote chasing” is the __ _ estry approach. A Boolean operator that delimits a search.

= B. Study Questions

A, Below are several research questions. Indicate two or three keywords that you

would use to begin a literature search on this topic.

Research Questions Keywords

a. What is the lived experience of surviving a suicide attempt? b. Do weekly text messages improve patient compliance with a

treatment regimen?

c. What is the decision-making process for a woman considering

having an abortion? e. Is the use of silk-like synthetic fabrics for the linens of postsurgical

patients effective in reducing the risk of pressure ulcers? d. Do children raised on vegetarian diets have different growth

patterns than other children? f. What is the course of appetite loss among cancer patients undergoing

chemotherapy? g. What is the effect of alcohol skin preparation before insulin

injection on the incidence of local and systemic infection? h. Are bottle-fed babies introduced to solid foods sooner than

breastfed babies?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

34 PART2 = Conceptualizing and Planning a Study to Generate Evidence for Nursing

2. Find the MeSH term that the following keywords would “map” onto in doing a

search in PubMed (HINT: Look in the “Search Details” field in the sidebar):

Keywords MeSH Terms

a. Cancer

b. Jet lag c. Alcohol abuse d. Telehealth nursing e. Decubitus ulcer it, COVE)

g. Hypochondria h. Mild cognitive impairment i. Extubation j. Sleep walking

3. Below are fictitious excerpts from research literature reviews. Each excerpt has a stylistic problem. Change each sentence to make it more acceptable stylistically for

scientific writing (use fictitious citations, if appropriate).

Original Revised

a. Most elderly people do not eat a balanced diet.

b. Studies have proved that most nurses prefer not to work the night shift.

c. It has been proved that psychiatric outpatients have higher than average rates of accidental deaths and suicides.

d. It is known that most tonsillecto- mies performed 3 decades ago were unnecessary.

e. Few smokers seriously try to break the smoking habit.

4. Read the literature review section from a research articles published in a nurs- ing journal about 5-10 years ago (some possible articles are suggested below). Search the literature for more recent research on the topic of the article and

update the original researchers’ literature review section. Use, among other search strategies, the descendancy approach. (Do not forget to incorporate in your review the findings from the cited research article itself.) Here are three possibilities published as open-access articles—links are provided in the Toolkit @ :

¢ Estrada, C., Danielson, K., Drum, M., & Lipton, R. (2012). Insufficient sleep in young patients with diabetes and their families. Biological Research for Nursing, 14, 48-54.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER5 ® Literature Reviews: Finding and Critically Appraising Evidence 35

¢ Nyamathi, A., Marfisee, M., Slagle, A., Greengold, B., Liu, Y., & Leake, B. (2012). Correlates of depressive symptoms among homeless young adults. Western Journal of Nursing Research, 34, 97-117.

¢ Sawin, E. M. (2012). “The body gives way, things happen”: Older women describe breast cancer with a non-supportive intimate partner. European Journal of Oncology Nursing, 16, 64-70.

S. Read the introduction/literature review section of one of the following reports, which are published as open-access articles (links are provided in the Toolkit @). Use the critical appraisal guidelines in Box 5.5 of the textbook (available as a Word document in the Toolkit @) to assess the quality of the review of the literature, keeping journal page constraints in mind as you do so:

¢ Brennan M., Milne C., Agrell-Kann M., & Ekholm B. (2017). Clinical evaluation

of a skin protectant for the management of incontinence-associated dermatitis. Journal of Wound, Ostomy, and Continence Nursing, 44, 172-180.

¢ Olorunfemi O., & Ojewole F. (2019). Medication belief as correlate of med-

ication adherence among patients with diabetes in Edo State, Nigeria. Nursing Open, 6, 197-202.

e Park K., & Song M. (2017). The effects of postdischarge telephone counseling and short message service on the knee function, activities of daily living, and life satisfaction of patients undergoing total knee replacement. Orthopedic Nursing,

36, 229-236.

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX K

Read the abstract, introduction, and the first subsection under “Methods” of the report

by Chase and colleagues (“Medication adherence interventions”) in Appendix K. Then answer the following questions:

Questions of Fact

a. What type of research review did the investigators undertake? b. Did the researchers provide a problem statement? Summarize the problem in a few

sentences. c. Did the researchers provide a statement of purpose? If so, what was it?

d. Which bibliographic databases did the researchers search? e. What keywords were used in the search? Were the keywords related to the indepen-

dent or dependent variable of interest? . Was an ancestry search conducted?

. Did the researchers restrict their search to English-language reports?

. How many studies ultimately were included in the review?

. Were the studies included in the review qualitative, quantitative, or both? et eeion ES

Generating and Assessing Evidence for Nursing Practice (11th ed.)

36 PART2 ® Conceptualizing and Planning a Study to Generate Evidence for Nursing

Questions for Discussion

a. Did the researchers do an adequate job of explaining the problem and their purpose

in undertaking the review? b. Did the researchers appear to do a thorough job in their search for relevant studies? c. Certain studies that were initially retrieved were eliminated. Do you think the

researchers provided a sound rationale for their decisions?

EXERCISE 2: STUDY IN APPENDIX L

Read the following abstract, introduction, and study design and methods sections of the report by Beck (“A metaethnography of traumatic childbirth”) in Appendix L. Then

answer the following questions:

Questions of Fact

a. What type of research review did Beck undertake? b. What was use purpose of this metasynthesis?

c. Did Beck’s review involve a systematic search tor evidence in bibliographic

databases? d. How many studies were included in the metasynthesis? e. Which qualitative research traditions were represented in the review?

Questions for Discussion

Did Beck do an adequate job of explaining the problem and the study purpose? b. Should Beck have searched for and included other qualitative studies on birth

trauma? If yes, what would have been her keywords?

EXERCISE 3: STUDY IN APPENDIX H

Read the article by Wilson and colleagues (“Individualized preoperative education”) in

Appendix H and use the critical appraisal guidelines tor a quantitative research report in Box S.3 of the textbook to answer as many questions as you can. Then read the critique

of the study that is also included in Appendix H, making note of issues that are absent in your appraisal (or in ours).

EXERCISE 4: STUDY IN APPENDIX |

Read the article by Sawyer and colleagues (“Obstructive sleep apnea”) in Appendix |

and use the critical appraisal guidelines for a qualitative research report in Box 5.4 of

the textbook to answer as many questions as you can. Then read the critique of the study that is also included in Appendix I, making note of issues that are absent in your appraisal (or in ours).

Generating and Asse

Ole ees literature Reviews: Finding and Critically Appraising Evidence 37

= D. The Toolkit 63

For Chapter 5, the Toolkit @ on thePoint’ contains a Word file with the following:

Example of a Flow Chart Documenting Literature Search Progress (Figure 5.2 of textbook)

Guide to a Comprehensive Critical Appraisal of Evidence Quality in a Quantitative Research Report (Expanded Box 5.3 of the textbook) Guide to a Comprehensive Critical Appraisal of Evidence Quality in a Qualitative Research Report (Expanded Box 5.4 of the textbook) Guidelines for Critically Appraising Literature Reviews (Box 5.5 of the textbook) Literature Review Data Extraction Form (not in textbook) Evidence Summary Table for Extracting and Recording Key Methodologic Features of Studies for a Literature Review (Figure 4 of Supplement B) Evidence Summary Table for Extracting and Recording Key Quantitative Findings for a Literature Review (Figure 5 of Supplement B) Evaluation Summary Sable for Recording Strengths and Weaknesses of Studies for a Literature Review (Figure 7 of Supplement B) Data Source Summary Table for a Literature Review (Figure 8 of Supplement B) Examples of Stylistic Problems for Research Literature Reviews (not in textbook) Cochrane Highly Sensitive Search Strategy for Identifying Randomized Trials in Medline (Not in textbook) Links to useful websites for Chapter 5 Links to relevant open-access journal articles for Chapter 5

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 6

Theoretical Frameworks

a A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 6. (Puzzles may be removed for easier viewing.)

CHAPTER6 #& Theoretical Frameworks 39

ACROSS

. The conceptual underpinnings of a study.

. The originator of the Health Promotion Model.

. One of the four elements in conceptual models of nursing is __ _ ironment.

. Abstractions assembled because of their relevance to a core concept form a(n) model.

. Readings in the theoretical literature may give rise to a research 5

. Psychiatric nurse researchers in the U.S. sometimes obtain funding from one of the institutes within the National Institutes of Health (NIH) with the acronym INTs ee

17. A theory that focuses on a specific phenomenon is sometimes called -range.

18. Another term for a schematic model is conceptual 19. The originator of the Science of Unitary Human Beings. 21. Roy'concepeualized the... = | ation Model of nursing. 22. The originator of the Theory of Uncertainty in Illness. 23. In phenomenology, researchers strive to suspend previously held _ _ _ stantive theo-

ries of the phenomenon under study. 24. A schematic is a mechanism for representing concepts with a minimal use of

words. 27. The mutually beneficial relationship between theory and research has been charac-

terizedas_ | rocal.

28. Becker’s model regarding people’s beliefs regarding their health is called the (acronym).

29. A(n) is a building block of a theory. 31. A construct that is a key mediator in many models of health behavior (e.g., the

Health Promotion Model) is efficacy. Boe emake cal theory is a paradigm that involves a critique of society.

DOWN

1. A theory aimed at explaining large segments of behavior or other phenomena.

[oe)

12.

. A theory that thoroughly accounts for or describes a phenomenon.

. A social psychological theory often used in nursing research is Bandura’s Social ___ _ _

itive Theory. . As classically defined, theories consist of concepts arranged in a logically interrelated

system, from which hypotheses can be generated.

. The Theory of Planned Behavior is an extension of the Theory of Action.

. The acronym for Pender’s model.

. A theory that focuses on a single piece of human experience is sometimes called a

middle- theory. Ethnographers begin their inquiry with a theory of _____ ure.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

ds}s

16.

L7,

18. 20:

24.

2D. 26:

50)

PART2 ™ Conceptualizing and Planning a Study to Generate Evidence for Nursing

If a study is based on a theory, its framework is called the

framework. The Stages of Change Model is also called the __ _ _ _ theoretical Model.

A schematic model is also called a conceptual Another name for a grand theory is a theory.

A prominent theoretical system in grounded theory is called interaction.

A practice theory is sometimes called a(n) theory.

The term theory always connotes a(n)__ = | action.

Three key concepts in the theory called the (acronym) are behaviors, inten-

tions, and subjective norms. Theories can be proved.

= B. Study Questions

1. Read some articles in recent issues of a nursing research journal. Identify at least two different theories cited by nurse researchers in these research reports.

. Select a model or theory described in this chapter. Develop a research hypothesis based on this framework.

. Select one of the research questions/problems listed below. Could the selected problem be developed within one of the models or theories discussed in this chapter? Defend your answer.

a. What influences an alcoholic’s decision to join an Alcoholics Anonymous group? b. What are the factors contributing to perceptions of fatigue among patients with

congestive heart failure?

c. What effect does the presence of the father in the delivery room have on the mother’s satisfaction with the childbirth experience?

d. The purpose of the study is to explore why some women fail to perform breast self-examination regularly.

e. What are the factors that lead to poorer health among low-income children than higher-income children?

. Suggest an important outcome that could be studied using the Health Promotion Model (i.e., a health-promoting behavior). Identify another theory described in this chapter that could be used to explain or predict the same outcome. Which theory or model do you think would do a better job? Why?

. Read one of the following articles. Do you think that the study involved a test of a model or theory? If not, how was the theory used?

¢ Im S., Maumann S., Ahn M., Kim H., Youn B., Park M., & Lee O. (2018). The experience of Korean nurses during the Middle East respiratory syndrome out- break. Nursing Science Quarterly, 31, 72-76.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER6 #® Theoretical Frameworks 41

e *Min H. Y., Kim S., & Cho H. (2017). Effects of an adolescent obesity manage- ment educational program on middle and high school teachers in South Korea. Asian Nursing Research, 11, 84-91.

¢ Nurse-Clarke N., DiCicco-Bloom B., & Limbo R. (2019). Application of caring

theory to nursing care of women experiencing stillbirth. MCN: The American Journal of Maternal-Child Nursing, 44, 27-32.

6. Read one of the following articles, and then apply the appraisal criteria in Box 6.2 of the textbook (available as a Word document in the Toolkit @ on thePoint’) to

evaluate the conceptual basis of the study.

¢ *Bergdahl E., Ternestedt B., Berteré C., & Andershed B. (2019). The theory of a

co-creative process in advanced palliative home care nursing encounters. Nursing Open, 6, 175-188.

¢ Como J. M. (2018). Health literacy and health status in people with chronic heart failure. Clinical Nurse Specialist, 32, 29-42.

e *Kisch A.M., & Forsberg A. (2017). The core of sibling stem cell donation: A grounded theory study. Open Nursing Journal, 11, 73-83.

e *Chen T., Kao C., Cheng S., & Chang Y. (2018). Uncertainty and depressive symptoms as mediators of quality of life in patients with heart failure. PLoS One, onCULUS 950:

7. Read the following open-access article (a link is provided in the Toolkit @), and then assess the following: (a) What evidence does the researchers offer to substanti- ate that their grounded theory is a good fit with their data? and (b) To what extent is it clear or unclear in the article that symbolic interactionism was the theoretical underpinning of the study?

e *Renolen A., Hoye S., Hjalmhult E., Danbolt L., & Kirkevold M. (2018).

“Keeping on track”—Hospital nurses’ struggles with maintaining workflow while seeking to integrate evidence-based practice into their daily work: A grounded theory study. International Journal of Nursing Studies, 77, 179-188.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX F

Read the abstract and introduction (all of the material before “Methods”) of the article

by Eckhardt and colleagues (“Fatigue in Coronary Heart Disease”) in Appendix F. Then

answer the following questions:

* A link to this open-access journal article is provided in the Toolkit @ for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

42 PART2 © Conceptualizing and Planning a Study to Generate Evidence for Nursing

Questions of Fact

a. Does the study by Eckhardt and colleagues involve a conceptual or theoretical frame-

work? If yes, what is it called? b. Is this framework one of the models of nursing cited in the textbook? Is it related to

one of those models? . Is the theory thoroughly described? Did the researchers adapt the theory? If yes, in what way was it adapted?

Does the report include a schematic model? What are the key concepts in the model? Does this model indicate relationships among the concepts? Did the report provide conceptual definitions of key concepts?

. Did the report explicitly present hypotheses deduced from the framework? et a See

Questions for Discussion

a. Does the link between the problem and the framework seem contrived? Do the hypotheses (if any) naturally flow from the framework?

b. Do you think any aspects of the research would have been different without the framework?

c. Would you describe this study as a model-testing inquiry or do you think the model was used more as an organizing framework?

EXERCISE 2: STUDY IN APPENDIX G

Read the abstract and introduction to the article by Byrne and colleagues (“Care transi- tion experiences”) in Appendix G. Then answer the following questions:

Questions of Fact

a. Did this article describe a conceptual or theoretical framework for the study? What is it called?

b. Did the study result in the generation of a theory? What was it called?

c. Did the report include a schematic model? If so, what are the key concepts in the model?

d. Did the report explicitly present hypotheses deduced from the framework? Did they undertake hypothesis-testing statistical analyses?

Questions for Discussion

a. Does the research problem naturally flow from the framework? Does the link between the problem and the framework seem contrived?

b. Do you think any aspects of the research would have been different without the framework?

c. How good a job do you feel the researchers did in tying the perspectives of the frame- work into the presentation of the findings and the discussion of the results?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER6 # Theoretical Frameworks 43

# D. The Toolkit 54)

For Chapter 6, the Toolkit @9 on thePoint’ contains a Word file with the following:

Some Questions for a Preliminary Assessment of a Model or Theory (Box 6.1 of the textbook)

Guidelines for Critically Appraising Theoretical and Conceptual Frameworks (Box 6.2 of the textbook)

Criteria to Determine if a Theory/Model is Being Tested in a Study Links to useful websites for Chapter 6 Links to relevant open-access journal articles for Chapter 6

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 7

Ethics in Nursing Research

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 7. (Puzzles may be removed for easier viewing.)

CHAPTER7 ® Ethics in Nursing Research 45

ACROSS

. A fundamental right for study participants is freedom from __. page eee ication is a form of research misconduct that involves changing or omit- ting data, or distorting results.

. Most disciplines have developed of ethics.

. Anonymity is a method of protecting participants’ ____ _ acy.

. Researchers should conduct a -benefit assessment of a planned study.

. A major ethical principle concerning maximizing benefits of research.

. The type of consent procedure that may be needed in qualitative research.

. A young is usually considered to be in a vulnerable group.

. Debriefings give participants an opportunity to complaints or ask questions.

. A payment sometimes offered to participants as an incentive to take part in a study.

. Data collection without participants’ awareness, using concealment.

. A guarantee of ___ _ imity means that the researchers collect their data without

being able to link the data to individual participants. . The report that is the basis for ethical regulations for studies funded by the U.S. government.

. Numbers or symbols used in place of names to protect individual identities (abbr.).

. Fraud and misrepresentations are examples of research nduct.

. A major ethical principle involves respect for human (reversed!).

. The return of a questionnaire is often assumed to demonstrate _ _ ied consent.

DOWN

. The Declaration of Hel is the code of ethics of the World Medical

Legislation passed in the United States in 1996 concerning privacy protection

(acronym). Informal agreement to participate in a study (e.g., by minors).

Association.

. The ethical principle of justice includes the right to treatment.

. Participants’ privacy is often protected by these procedures, even though the

researchers know participants’ identities. . People can make informed decisions about research participation when there is full

. A committee (in the United States) that reviews the ethical aspects of a study

(acronym).

. A situation in which private information is divulged is a of confidentiality.

. The appropriation of someone’s ideas or words without proper credit.

. When short ___ are used to document consent, third-party witnesses are needed.

. A vulnerable, institutionalized group with diminished autonomy.

. Most studies adhere to the practice of obtaining written consent.

. A conflict between the rights of participants and the demands for rigorous research

creates an ethical

Generating and Assessing Evidence for Nursing Practice (11th ed.)

46 PART2 ® Conceptualizing and Planning a Study to Generate Evidence for Nursing

20. Researchers must adhere to guidelines in conducting research with humans

or animals. i 22. Mismanagement of study can result in a type of research misconduct.

26. Numbers used in place of names to protect individual identities (abbr.).

= B. Study Questions

1. Below are brief descriptions of several studies. Suggest some ethical dilemmas that

are likely to emerge for each.

a. A study of coping behaviors among rape victims b. An unobtrusive observational. study of fathers’ behaviors in the delivery room c. An interview study of the factors influencing heroin addiction d. A study of pain assessment among developmentally delayed children e. An investigation of verbal interactions among schizophrenic patients f. A study of the effects of a new treatment for adolescents with sickle cell disease g. A study of the relationship between sleeping patterns and acting-out behaviors in

hospitalized psychiatric patients

2. Evaluate the ethical aspects of one of the following studies using the critical appraisal guidelines in Box 7.3 of the textbook (available as a Word document in the Toolkit 3 on thePoint’), paying special attention (if relevant) to the manner in

which the subjects’ heightened vulnerability was handled.

e *Athanasopoulou, C., Valimaki, K., Lottyniemi, E., Bertsias, A., Basta, M., ...

Lionis, C. (2017). Internet use, eHealth literacy and attitudes toward computer/

internet among people with schizophrenia spectrum disorders. BMC Medical Informatics and Decision Making, 17, 136.

e *Fuller, S., Koester, K., Guinness, R., & Steward, W. (2017). Patients’ percep-

tions and experiences of shared decision-making in primary HIV care clinics. Journal of the Association of Nurses in AIDS Care, 28, 75-84.

e Gaffney, K., Kerner, D., Kitsantas, P., Brito, A., Ramos, K., Pereddo, G., &

Villatoro, L. (2019). Early life factors for overweight risk among infants of

Hispanic immigrant mothers. Journal of Pediatric Health Care, 33, 35-41.

e Staneva, A., Morawska, A., Bogossian, F., & Wittkowski, A. (2018). Maternal

psychological distress during pregnancy does not increase the risk for adverse birth outcomes. Women c Health, 58, 92-111.

3. In the Supplement to Chapter 7 on the book’s website, consider two of the studies with ethical problems that were described: the Tuskegee Study of syphilis among black men, and the study in which children at the Willowbrook School were infected with the hepatitis virus. Which ethical principles were transgressed in these studies?

*A link to this open-access article is provided in the Toolkit 9 for this chapter

CHAPTER7 ® Ethics in Nursing Research 47

4. In the following study, the authors indicated that informed consent was not required because there was “no deviation from the standard of care or risk to the subjects” (p. 108). Skim the introduction and method section of this paper and comment on the researchers’ decision to not obtain informed consent:

e Byers, J. F., Lowman, L. B., Francis, J., Kaigle, L., Lutz, N. H., Waddell, T., Diaz, A. L. (2006). A quasi-experimental trial on individualized, developmentally supportive family-centered care. Journal of Obstetric, Gynecologic, & Neonatal Nursing, 35(1), 105-115.

5S. Below is a brief description of the ethical aspects of a fictitious study, followed by a critique. Do you agree with the critique? Can you add other comments relevant to the ethical dimensions of the study?

Fictitious Study. Fortune conducted an in-depth study of nursing home residents to

explore whether their perceptions about personal control over decision-making differed

from the perceptions of the nursing staff. The investigator studied 25 nurse-patient

dyads to assess whether there were differing perceptions and experiences regarding

control over activities of daily living, such as arising, eating, and dressing. All of the

nurses in the study were employed by the nursing home in which the patients resided.

Because the nursing home had no |RB, and because Fortune’s study was not funded

by an organization that required IRB approval, the project was not formally reviewed.

Fortune sought permission to conduct the study from the nursing home administrator.

She also obtained the written consent of the legal guardian or responsible family

member of each patient. All study participants were fully informed about the nature

of the study. The researcher assured the nurses and the legal guardians and family

members of the patients of the confidentiality of the information. Data were gathered

primarily through in-depth interviews with the patients and the nurses, at separate

times. The researcher also observed interactions between the patients and nurses. The

findings from the study suggested that patients perceived that they had more control

over all aspects of the activities of daily living (except eating) than the nurses perceived

that they had. Excerpts from the interviews were used verbatim in the research report,

but Fortune did not divulge the location of the nursing home, and she used fictitious

names for all participants.

Critique. Fortune did a reasonably good job of adhering to basic ethical principles in

the conduct of her research. She obtained written perinission to conduct the study

from the nursing home administrator, and she obtained informed consent from the

nurse participants and the legal guardians or family members of the patients. The

study participants were not put at risk in any way, and the patients who participated

may actually have enjoyed the opportunity to have a conversation with the researcher.

Fortune also took appropriate steps to maintain the confidentiality of participants. It

is still unclear, however, whether the patients knowingly and willingly participated in

the research. Nursing home residents are a vulnerable group. They may not have been

aware of their right to refuse to be interviewed without fear of repercussion. Fortune

Generating and Assessing Evidence for Nursing Practice (11th ed.)

48 PART2 «# Conceptualizing and Planning a Study to Generate Evidence for Nursing

could have enhanced the ethical aspects of the study by taking more vigorous steps

to obtain the informed, voluntary consent of the nursing home residents themselves

or to exclude patients who could not reasonably be expected to understand the

researcher’s request. Given the vulnerability of the group, Fortune probably should

have established her own review panel composed of peers and interested lay people to

review the ethical dimensions of her project.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

Read the Methods section of the article by Nyamathi and colleagues (“Achieving drug and alcohol abstinence”) in Appendix A, and then answer the following questions:

Questions of Fact

a. Does the report indicate that the study procedures were reviewed by an IRB or other

similar ethical review committee? b. Would the participants in this study be considered “vulnerable” ?

. Were participants subjected to any physical harm or discomfort or psychological dis- tress during the study? Did the researchers make efforts to minimize harm and maxi- mize good? Were participants deceived in any way? Were participants coerced into participating in the study?

Were appropriate informed consent procedures used? Was there full disclosure, and was participation voluntary?

Does the report discuss steps that were taken to protect the privacy and confidential- ity of study participants?

Questions for Discussion

a. Do you think the benefits of this research outweighed the costs to participants—what is the overall risk/benefit ratio? Would you characterize the study as having minimal risk?

Do you consider that the researchers took adequate steps to protect the study partici- pants? If not, what else could they have done?

The report indicates that the participants were paid incentives during the study. Comment on how appropriate you think this was.

EXERCISE 2: STUDY IN APPENDIX B

Read the Methods section of the article by Cricco—Lizza (“Infant feeding beliefs”) in Appendix B, and then answer the following questions:

CHAPTER7 ® Ethics in Nursing Research 49

Questions of Fact

ae Does the report indicate that the study procedures were reviewed by an IRB or other similar ethical review committee?

. Would the study participants in this study be considered “vulnerable”? Were participants subjected to any physical harm or discomfort or psychological dis- tress during the study? Did the researcher make efforts to minimize harm and maxi- mize good?

Were participants deceived in any way?

Were participants coerced into participating in the study? . Were appropriate informed consent procedures used? Was there full disclosure, and was participation voluntary?

. Does the report discuss steps that were taken to protect the privacy and confidential- ity of study participants?

Questions for Discussion

Do you think the benefits of this research outweighed the costs to participants—what is the overall risk/benefit ratio? Would you characterize the study as having minimal risk? Do you consider that the researcher took adequate steps to protect the study partici- pants? If not, what else could she have done?

. The report did not indicate that the study participants were paid a stipend. Do you think a stipend would have been necessary or appropriate in this study?

D. The Toolkit x)

For Chapter 7, the Toolkit G9 on thePoint’ contains a Word file with the following:

Worksheet for Assessing Potential Benefits and Risks of Research to Participants (Based on Box 7.1 of the textbook) Example of an Information Sheet for Participation in a Research Project, Example #1 (Figure 7.1 of the textbook) Example of an Informed Consent Form for Participation in a Research Project,

Example #2* Example of an Informed Assent Form for Children’s Participation in a Research Project, Example #3* Example of a Consent Form/Information Sheet Checklist* Simplifying Language in Informed Consent: Selected Examples* Checklist for De-Identifying Data to Comply with HIPAA Privacy Regulations*

Example of an Authorization Form to Disclose Individually Identifiable Health

Information, in Compliance with HIPAA Privacy Regulations*

Example of a Confidentiality Pledge for Project Staff*

*These items do not appear in the textbook.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

50 PART 2 ® Conceptualizing and Planning a Study to Generate Evidence for Nursing

¢ Guidelines for Critically Appraising the Ethical Aspects of a Study (Box 7.3 of the textbook) -

e Links to useful websites for Chapter 7 e Links to relevant open-access journal articles for Chapter 7

CHAPTER 8

Planning a Nursing Study

& A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 8. (Puzzles may be removed for easier viewing.)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

52 PART2 ® Conceptualizing and Planning a Study to Generate Evidence for Nursing

ACROSS

Ale

des

. A design involving comparisons of multiple age groups is a c

. The criterion called _

The use of multiple sources or referents to draw conclusions about what constitutes

the truth. Quantitative researchers aim to control ____ _ _ eous variables.

The type of design in which different people are compared is a(n) -subjects

design. . An important criterion for evaluating quantitative studies, referring broadly to the soundness of evidence. — ility is the extent to which qualitative study methods engender confidence

in the truth of the data and interpretations. Ad learned in a pilot study might be that more than one site is needed to achieve the desired sample size.

. A bias that is systematic bias is random bias.

. When a researcher is not interested in studying change, data are usually collected at

a(n) point in time.

comparison

design . Loss of participants from a study over time is called __ _ rition. . A comparison based on relative rankings might involve asking whether, for exam- ple, those with high levels of pain have levels of hopefulness than those with less pain.

. When reflexivity is rigorously pursued, reflections and personal values are in a journal or in memos.

. A small-scale study is sometimes undertaken to the methods and procedures that would be used in a larger study. A study is sometimes undertaken in a preliminary effort to assess method- ologic decisions that would be used in a subsequent larger study.

__ iability refers to the accuracy and consistency of informa- tion obtained in a study.

. One type of longitudinal study is a follow-___ study.

. The process of pondering and thinking critically on the self.

DOWN

A(n) study involves multiple points of data collection with different samples from the same population to detect patterns of change over time.

One critical design decision involves whether there will be a(n) , or whether the study will be nonexperimental.

. The type of study that involves multiple points of data collection over an extended time.

. Gaining entrée is often an ongoing process ofes__ | ing relationships and rapport with gatekeepers.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTERS & Planning a Nursing Study 53

. The concept of involves having certain features of the study established by chance.

. Through self-reports, researchers can gather data about events occurring in the past.

. Another term for extraneous variable.

. An influence that distorts study results.

. Methods of research control are used to clarify the effect of independent variables Onthe = es t variable.

. In planning a study, it is useful to develop a for the accomplishment of major tasks.

. Attrition is problematic because those who drop ____ of a study are rarely a random subset of all participants, and so a bias can emerge.

. The type of design involving the comparison of a single group at multiple points in time or under different circumstances is a subjects design.

akeseartchc. is used to hold constant extraneous influences on the outcome

variable. . Researchers chose from a myriad of methodological __ _ _ ons in designing a

study. . For gaining entrée, the development of between researchers and gatekeepers

is a central issue.

= B. Study Questions

il A team of nurses wanted to assess whether a special intervention would lower the risk of bone mineral density loss among women undergoing chemotherapy for breast cancer. Think of how a study could be designed. Could the study be designed as any of the following—if, yes, provide examples of how this could be

designed:

e A within-group study? A between-group study? A cross-sectional study? A longitudinal study?

. Read the following study. Does anything in the report suggest reflexivity?

e Sanon, M., Spigner, C., & McCullagh, M. (2016). Transnationalism and

hypertension self-management among Haitian immigrants. Journal of Transcultural Nursing, 27, 147-156.

. Read the following study, and discuss the ways in which the researchers used

triangulation:

¢ Gil, E., Agmon, M., Hirsch, A., Ziv, M., & Zisberg, A. (2018). Dilemmas for

guardians of advanced dementia patients regarding tube feeding. Age and Agine,

47, 138-143.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

54 PART2 «® Conceptualizing and Planning a Study to Generate Evidence for Nursing

4. Read one of the following studies and try to estimate what a timeline for the study

might have looked like (If useful, use the timeline in the Toolkit @ ):

° “Jeffs, L., Saragosa, M., Law, M., Kuluski, K., Espin, S., & Merkley, J. (2017).

The role of caregivers in interfacility care transitions: A qualitative study. Patient

Preferences and Adherence, 11, 1443-1450. e *Mohammadi, S., Kermanshahi, $., & Vanaki, Z. (2019). Pity: A qualitative

study on Iranian women with breast cancer. Patient Preference and Adherence,

owe l eso.

e Webb, L. A., & McDonnell, K. (2018). Not a death sentence: Perspectives of

African American women living with lung cancer. Oncology Nursing Forum, 45,

46-54.

5. Read one of the following longitudinal studies and answer these questions: Could the study have been designed as a cross-sectional study? If not, why not? If yes, describe how the study could have been designed.

e *Ivars, K., Nelson, N., Theodorsson, A., Theodorsson, E., Strom, J., & Morelius,

E. (2017). Development of salivary cortisol circadian rhythm in preterm infants.

PLoS One, 12, e0182685.

of Tee, L, W., Lin, C., Li, He, Hsiao, Ps Chung, As Hsieh, ©. sHsus- se. (Oly).

Body composition changes in male patients with chronic obstructive pulmonary disease: Aging or disease process? PLoS One, 12, e0180928.

e Veldhuis, C., Hughes, T., Drabble, L., Wilsnack, S., Riggle, E., & Rostosky, S.

(2019). Relationship status and drinking-related outcomes in a community sample

of lesbian and bisexual women. Journal of Social and Personal Relationships, 36, 244-268.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX D

Read the introduction and methods section of the article by Kim and colleagues (“Dietary approaches to stop hypertension”) in Appendix D. Then answer the following questions:

Questions of Fact

a. Did this study involve an intervention?

b. Was this study designed to make any comparisons? If so, what type of comparison was made?

*A link to this open-access journal is provided in the Toolkit 9 for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTERS # Planning a Nursing Study 55

c. Did this study use a within-subjects design, a between-subjects design, a mixed design—or none of these?

d. Was the study cross-sectional or longitudinal? How many times were data collected from study participants?

e. What was the location for this study?

What were the primary methods of data collection? g. Was this a pilot study? If yes, what were the study objectives?

Questions for Discussion

a. Over how many months do you think this study was conducted? b. Try to find an example of how the researchers controlled extraneous variables by

“holding constant” possible confounding influences. c. How would you rate the methods of data collection in terms of structure, researcher

obtrusiveness, and objectivity? Discuss how appropriate the researchers’ data collection decisions were.

d. Describe some of the things you might recommend doing in a larger-scale study designed to assess the intervention. Do you think the intervention merits a larger, more rigorous study?

EXERCISE 2: STUDY IN APPENDIX |

Read the introduction and methods section of the article by Sawyer and colleagues (“Obstructive sleep apnea”) in Appendix I. Then answer the following questions:

Questions of Fact

a. Did this study involve an intervention?

b. Was this study designed to make any comparisons? If so, what type of comparison was

made? c. Did this study use a within-subjects design, a between-subjects design, a mixed

design—or none of these? d. Was the study cross-sectional or longitudinal? How many times were data collected

from study participants? e. What was the location for this study?

What were the primary methods of data collection?

g. Was this a pilot study? If yes, what were the study objectives? ban’

Questions for Discussion

a. How would you rate the methods of data collection in terms of structure, researcher obtrusiveness, and objectivity? Discuss how appropriate the researchers’ data collec-

tion decisions were. b. Describe any triangulation (if any) that was used in this study.

c. Discuss whether there is any evidence of reflexivity in this study.

d. Try to develop a timeline for the major activities in this study.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

56 PART2 ® Conceptualizing and Planning a Study to Generate Evidence for Nursing

= D. The Toolkit : 63 For Chapter 8, the Toolkit @3 on thePoint’ contains a Word file the following:

Sample Letter of Inquiry for Gaining Entrée into a Research Site (Figure 8.1 of the textbook)

Project Timeline, in Calendar Months, for a 24-Month Project (Figure 8.2 of the textbook)

Worksheet for Documenting Design Decisions Links to useful websites for Chapter 8 Links to relevant open-access journal articles for Chapter 8

Designing and

Conducting Quantitative Studies

to Generate Evidence for Nursing

CHAPTER 9 —~

Quantitative Research Design

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 9. (Puzzles may be removed for easier viewing.)

CHAPTER9 ®& Quantitative Research Design 59

ACROSS

1. That against which the outcomes for an experimental group are compared; the ide-

alized model for inferring causal relationships. A _____ orical control group in a quasi-experiment uses data from an earlier point in time

. A(n) ___ ention control group is used to offset the effect of special consideration to the experimental group.

9p Ne ied randomization involves the random assignment of people within specified subgroups.

A ene, ive design begins with the effect and looks back in time for a

cause. . A(n) -posttest design involves the collection of outcome before and after the intervention.

. A major bias in research that does not involve random assignment is -selection. Ams study: and « ive design begins with the cause and looks forward in time to an

effect. . Those with a specified condition or disease at a fixed point, based on cross-sectional data from the population at risk, typically reported as a rate.

. A “box” in a diagram of a factorial design.

. One criterion for causality in health research is plausibility.

. One method of concealing information about upcoming assignments is to place information in opaque __ _ _ ed envelopes (the SNOSE system).

. In the medical literature, the term sometimes used for group or condition.

. To protect from possible bias, concealment is recommended during randomization.

. Ina typical sequence of steps in an RCT, to be in the study is obtained from participants before they are randomized to groups. The effect is a bias that can arise from people’s awareness of being studied; named after a plant in which industrial experiments were undertaken.

DOWN

ite U ny) design is the term used in the medical literature for a nonexperimen- tal prospective study.

2. A(n) experiment looks at the effects of an event that transpires in a fairly

ies)

random fashion, such as a hurricane.

Another name for an experiment (acronym).

The type of randomization involving random assignment of large units (e.g.,

hospitals).

The -only (posttest only) design collects data from participants following

administration of the intervention only.

A type of intervention that is tailored to particular characteristics of people

(acronym).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

60 PART3 Designing and Conducting Quantitative Studies

ietes -listed control group gets the intervention, after a delay.

12. A pseudointervention. ~

Seva test is a measure of an outcome after the intervention has been administered.

14. Another term for an intervention. 15. A type of quasi-experimental design involving multiple points of data collection

before and after an intervention is a time

17. The gold standard design for inferring cause-and- erfecs relationships is a true

18. One method of randomization involves using a(n) of random numbers.

20. A type of design in which subjects serve as their own controls. 22. In permuted randomization, people are allocated to treatment groups in

small sets. 23. In an experiment, the variable that is manipulated (acronym). 25. Nonexperimental studies that test theory-driven causal linkages often use

analysis. 27. When there is no blinding, the study is sometimes described as a(n)

study. 30. A factorial study involves at least independent, manipulated variables.

= B. Study Questions

1. Suppose you wanted to study self-efficacy among successful dieters who lost 20 or more pounds and maintained their weight loss for at least 6 months. Specify at least two different types of comparison strategies that might provide a useful comparative context for this study. Do your strategies lend themselves to experimental manipula- tion? If not, why not?

2. Below is a list of 20 people who have volunteered for a study of the effects of noise on pulse rate. Ten must be assigned to the low-volume noise group and 10 to a high- volume noise group. Use the table of random numbers in Table 9.2 of the text (or in the table of random numbers in the accompanying Toolkit G9) to randomly assign people to groups.

L. Bentley M.McGowan

L. Boehm A. Messenger

D.Chorna U. Moore

H.Dann P. Morrill

L. Dansker GO Dea

E. Gordon A. Petty

R. Greenberg D. Roberts

Jelarte V. Rotan

S. Kulli H. Seidler P. Labovitz R. Smalling

CHAPTERS #® Quantitative Research Design 61

Assume all participants in the first column are in their 20s and all those in the second column are in their 30s. How good a job did your randomization do in terms of equalizing the two groups according to age? Add 10 more names to each age group and assign these additional 20 subjects. Now compare the low-volume and high-volume groups in terms of the age distribution. Did doubling the sample size improve the distribution of subjects’ ages within the two volume-level groups?

3. A nurse researcher found a relationship between teenagers’ level of knowledge about birth control and their level of sexual activity. That is, teenagers with higher levels of sexual activity knew more about birth control than teenagers with less sexual activity. Suggest at least three interpretations for this finding. Is this a research prob- lem that is inherently nonexperimental? Why or why not?

4. The following study, published in an open-access journal article (link is provided in the Toolkit @), was described as a double-blind experiment. Review the design for

this study, and comment on the appropriateness of the masking procedures. Who was blinded—and who was not? What biases were the researchers trying to avoid? Were they successful?

e *Jull, A., Wadham, A., Bullen, C., Parag, V., Kerse, N., & Waters, J. (2017). Low

dose aspirin as adjuvant treatment for venous leg ulceration: Pragmatic, ran- domised, double-blind, placebo-controlled trial (Aspirin4 VLU). BMJ, 358, j5157.

5. Suppose that you were interested in testing the hypothesis that regular ingestion

of aspirin reduced the risk of colon cancer. Describe how such a hypothesis could be tested using a retrospective case-control design. Now describe a prospective cohort design for the same study. Compare the strengths and weaknesses of the two approaches. Explain potential barriers to conducting this study as an RCT.

6. Read the introduction and methods section of one of the following reports. Use the guidelines in Box 9.1 of the textbook (available as a Word document in the Toolkit @ ) to critically appraise features of the research design:

e Hauken, M., Senneseth, M., Dyregrov, A., & Dyregrov, K. (2018). Anxiety and the

quality of life of children living with parental cancer. Cancer Nursing, 41, E19-E27. e Kim, H. &, & Bang, K. (2018). The effects of enteral feeding improvement

massage on premature infants: A randomised controlled trial. Journal of Clinical Nursing, 27, 92-101.

e *Weldam, S., Schuurmans, M., Zanen, P., Heijmans, M., Sachs, A., & Lammers,

J. (2017). The effectiveness of a nurse-led illness perception intervention in COPD

patients: A cluster randomised trial in primary care. ERJ Open Research, 3,

00115-2016. e *Yoshikawa, Y., Ohmaki, E., Kawahata, H., Maekawa, Y., Ogihara, T.,

Morishita, R., & Aoki, M. (2019). Beneficial effect of laughter therapy on physio-

logical and psychological function in elders. Nursing Open, 6, 93-99.

* A link to this open-access article is provided in the Toolkit €} for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

62 PART3 ® Designing and Conducting Quantitative Studies

7. A nurse researcher is interested in studying the success of several different

approaches to feeding patients with dysphagia. Can the researcher use a correla-

tional design to examine this problem? Why or why not? Could an experimental or

quasiexperimental approach be used? How?

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

Read the Methods section of the report by Nyamathi and colleagues (“Achieving Drug and Alcohol Abstinence”) in Appendix A. Then answer the following questions.

Questions of Fact

a. Was there an intervention in this study? b. Is the design for this study experimental, quasiexperimental, or nonexperimental?

c. Was this a cause-probing study? d. What were the independent and dependent variables? e. Was randomization used? If yes, what method was used to assign subjects to groups?

f. Was allocation concealment used? g. In terms of the control group strategies described in the textbook, what approach did

the researchers use? h. What is the specific name of the research design used in this study? i. Is the overall design a within-subjects or between-subjects design? j. Was any blinding (masking) used in this study? k. Would this study be described as longitudinal? Would it be described as prospective?

Questions for Discussion

a. What was the intervention? Comment on how well the intervention was described, including a description of how it was developed and refined.

b. Comment on the researchers’ control group strategy. Could a more powerful or effec- tive strategy have been used?

c. Discuss ways in which this study achieved or failed to achieve the criteria for making causal inferences.

d. Comment on the researchers’ use or nonuse of blinding. Were there groups who were not blinded who should have been?

e. Comment on the timing of postintervention data collection.

EXERCISE 1: STUDY IN APPENDIX F

Read the Methods section of the article by Eckhardt and colleagues (“Fatigue in Coronary Heart Disease”) in Appendix F. Then answer the following questions.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER9 # Quantitative Research Design 63

Questions of Fact

SO moan FP

Was there an intervention in this study? Is the design for this study experimental, quasiexperimental, or nonexperimental? Was this a cause-probing study? What were the independent and dependent variables in this study? Was the independent amenable to manipulation? Was randomization used? If yes, what method was used to assign subjects to groups?

What is the specific name of the research design used in this study? Was any blinding (masking) used in this study? Would this study be described as longitudinal? Would it be described as prospective?

Questions for Discussion

Discuss ways in which this study achieved or failed to achieve the criteria for making causal inferences. Comment on the timing of data collection. Would a different time perspective be useful?

D. The Toolkit 54)

For Chapter 9, the Toolkit @9 on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising Research Designs in Quantitative Studies (Box 9.1 of the textbook)

Table of Random Numbers: 2-Digit Numbers Table of Random Numbers: 3-Digit Numbers List of Situations that are Especially Conducive to a Randomized Experimental

Design

Joanna Briggs Institute Levels of Evidence for Prognosis Studies Links to useful websites for Chapter 9 Links to relevant open-access journal articles for Chapter 9

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 10

Rigor and Validity in

Quantitative Research

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 10. (Puzzles may be removed for easier viewing.)

CHAPTER 10 ® Rigor and Validity in Quantitative Research 65

ACROSS

1. Intervention concerns the faithfulness of implementing a treatment. 6. Blinding can be used to address a construct validity threat stemming from what a

researcher to find. 8. There is less extraneous variation in delivering a treatment when research personnel

are well

9. When statistical is strengthened, statistical conclusion validity is enhanced.

12. The testing threat is the effect of a(n) on participants’ performance on a posttest.

15. The internal validity threat that can arise from changes attributable to the passage of time 1s calledii 1M) 8) tion.

16. In lieu of pair matching, researchers sometimes __ _ ance groups being compared on confounding variables to enhance comparability.

17. Problems with construct validity involve a(n) (i.e., a lack of congruence)

between a higher order construct and the manner in which it is operationalized. 20. Attrition can result in the internal validity threat called j 22. The biggest threat to internal validity is__§_§ = _ on—that is, the risk of preexist-

ing differences between groups being compared that could affect the outcomes. 23 Each to validity can undermine researchers’ ability to make appropriate

inferences. 25. Constancy of conditions is enhanced when there is a formal for

delivering an intervention. 29. Threats to internal validity create rival explanations for the of an

outcome. 30. Internal validity can be enhanced through design decisions and through

a(n) of biases after the data have been collected.

31. A drawback of using homogeneity to control confounding variables is the possible restriction on the __—_ of the outcome variable.

DOWN

2. The type of validity that concerns inferences that study outcomes were caused by the independent variable rather than by other factors.

3. An aspect of intervention fidelity concerns whether or not those receiving the inter- vention actually the skills and behaviors they learned in the intervention

in real life situations. 4. An intention-to-____——_ analysis involves analyzing outcomes for all people in

their original treatment conditions.

5, ____ rnal validity concerns inferences about the generalizability of findings to

other settings and groups.

7. One method of statistically controlling confounding variables is through analysis of

Generating and Assessing Evidence for Nursing Practice (11th ed.)

27.

Dis

. A construct validity threat concerns people’s

. The loss of people over the course of a study is called

PART3 ® Designing and Conducting Quantitative Studies

. Efforts to balance internal and external validity have given rise to ___ _ gmatic

clinical trials that are conducted in real-world clinical settings. Pit heat : ivity to the overall research

situation, not simply to a treatment (e.g., the Hawthorne effect). . A threat to internal validity is temporal , which concerns questions about which came first, the independent variable or dependent variable.

. Effectiveness trials are interested in external validity issues, while trials are more concerned with internal validity.

tion, which can cause

biases.

. A threat to internal validity concerning the occurrence of external events that could

affect outcomes.

. The bias that is of concern in crossover designs due to different scheduling of conditions.

. Loss of participants sometimes requires efforts to them if they have moved, and this is aided by the collection of contact information.

. A potential of enhancements to internal validity is that external validity could be reduced. Statistical conclusion validity concerns inferences that observed relationships between the independent and dependent variable are and replicable. In a(n) protocol analysis, participants in the analysis are ones who actually received the treatment condition to which they were assigned.

= B. Study Questions

il. Suppose you wanted to compare the growth of infants whose mothers were heroin

addicts with that of infants of nonaddicted mothers. Describe how you would design such a study, being careful to indicate what confounding variables you would need to control and how you would control them. Identify the major threats to the inter- nal validity of your design.

. A nurse researcher is interested in testing the effect of a special high-fiber diet on cardiovascular risk factors (e.g., cholesterol level) in adults with a family history of cardiovascular disease. Describe a design you would recommend for this problem,

being careful to indicate what confounding variables you would need to control and how you would control them. Suggest methods of strengthening the power of the design. Identify possible threats to the internal validity of your design.

. Read the methods section of one of the following quasi-experimental studies.

Identify one or more threats to the internal validity of the study. Then describe strat- egies that could be used to strengthen the study’s internal validity.

¢ Can Gir, G., & Okanli, A. (2019). The effects of cognitive-behavioral model- based intervention on depression, anxiety, and self-efficacy in alcohol use disor- der. Clinical Nursing Research, 28, 52-78.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 10 ® Rigor and Validity in Quantitative Research 67

° *Shen, C., Wan, A., Kwok, L., Pang, S., Wang, X., Stewart, S., ... Chan, S. (2017). A community-based intervention program to enhance neighborhood cohesion: The Learning Families Project in Hong Kong. PLoS One, 12, e018722.

e Su, K., Kou; Y., Lin, F., Wu, C., Feng, J.PHuane<St, . ChanevS 2017) A simplified prevention bundle with dual hand hygiene audit reduced early-onset ventilator-associated pneumonia in cardiovascular surgery units: An interrupted time-series analysis. PLoS One, 12, e0182252.

4. Suppose you were studying the effects of range-of-motion exercises on radical mas-

tectomy patients. You start your experiment with 50 experimental subjects and 50 control subjects. Your intervention requires experimental subjects to come for daily sessions over a 2-week period, while control subjects come only once at the end of 2 weeks. Your final group sizes are 40 for the experimental group and 49 for the control group. The results of your study indicate that the experimental group did better in raising the arm of the affected side above head level. What effects, if any, do you think that attrition might have on the internal validity of your study?

5. For each of the following research questions, indicate the type of design you could use to best address it; indicate confounding variables that should be controlled and how your design would control them.

e¢ What effect does the presence of the newborn’s father in the delivery room have on the mother’s subjective report of pain?

e What is the effect of different types of bowel evacuation regimes for quadriplegic patients?

¢ Does the inability to speak and understand English affect a person’s access to hospice services?

6. Read the introduction and methods section of one of the following reports. Use the critical appraisal guidelines in Box 10.1 of the textbook (available as a Word docu- ment in the Toolkit G3) to assess the study’s validity.

© Caldwell, A., Tingen, M., Nguyen, J., Andrews, J., Heath, J., Waller, J., & Treiber, F. (2018). Parental smoking cessation: Impacting children’s tobacco smoke exposure in the home. Pediatrics, 141, S96-S106.

e *Lu, Y., Hao, C., He, W., Tang, C., & Shao, Z. (2018). Experimental research

on preventing mechanical phlebitis arising from indwelling needles in intravenous therapy by external application of mirabilite. Experimental and Therapeutic

Medicine, 15, 276-282.

e *Senoi, D., & Asian, E. (2017). The effects of cold application to the perineum on pain relief after vaginal birth. Asian Nursing Research, 11, 276-282.

e VanGraafeiland, B., Foronda, C., Canderwagen, S., Allan, L., Bernier, M., Fishe,

J., Hunt, E., & Jeffers, J. (2019). Improving the handover and transport of criti-

cally ill pediatric patients. Journal of Clinical Nursing, 28, 56-65.

* A link to this open-access article is provided on the Toolkit 56) for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

68 PART3 ® Designing and Conducting Quantitative Studies

C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

1 . Read the methods section of the article by Nyamathi and colleagues (“Achieving

drug and alcohol abstinence”) in Appendix A. Then answer the following questions:

Questions of Fact

Toa mono To —

Which of the methods of research control described in this chapter were used to con-

trol confounding variables? Could this study have been designed as a crossover study? What confounding variables were controlled? Was there any attrition in this study? Was attention paid to treatment fidelity? Is there evidence that constancy of conditions was achieved? Were group treatments as distinct as possible to maximize power? If not, why not? Was selection a threat to the internal validity of this study?

. Was mortality a threat to the internal validity of this study?

Questions for Discussion

a. Does this study seem strong in terms of statistical conclusion validity? How could statistical conclusion validity have been strengthened?

b. Discuss issues relating to the intervention fidelity in this study.

. Is this study strong in internal validity? What, if any, are the threats to the internal validity of this study?

. Is this study strong in construct validity? What, if any, are the threats to the construct validity of this study?

. Is this study strong on external validity? What, if any, are the threats to the external validity of this study?

EXERCISE 2: STUDY IN APPENDIX D

Read the methods and results sections of the report by Kim and colleagues (“Dietary approaches to stop hypertension”) in Appendix D. Then answer the following questions:

Questions of Fact

a0 Ff f

. Is the design for this study experimental, quasi-experimental, or nonexperimental?

. What were the independent and dependent variables in this study?

. Was randomization used? What was the unit of randomization?

. Which of the methods of research control described in this chapter were used to con- trol confounding variables?

. Could history be a threat to the internal validity of this study?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 10 ® Rigor and Validity in Quantitative Research 69

f. Was there any attrition in this study? Could mortality have been a threat to internal

g°

validity?

Could the threat of maturation be relevant in this study?

Questions for Discussion

a. What was the intervention? Comment on how well the intervention was described,

including the description of how it was developed and refined. b. Comment on the researchers’ counterfactual strategy. Could a more powerful or

effective strategy have been used? c. Does this study seem strong in terms of statistical conclusion validity? How could

statistical conclusion validity have been strengthened? d. Is this study strong in internal validity? What, if any, are the threats to the internal

validity of this study?

e. Is this study strong in construct validity? What, if any, are the threats to the construct validity of this study?

f. Is this study strong on external validity? What, if any, are the threats to the external validity of this study?

= D. The Toolkit 5K)

For Chapter 10, the Toolkit G3 on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising Design Elements and Study Validity in Quantitative Studies (Box 10.1 of the textbook) Example of a Table of Contents for a Procedures Manual for an Intervention Study Example of an Observational Checklist for Monitoring Delivery of an Intervention Example of a Contact Information Form for a Longitudinal Study Matrix for Design Decisions and Possible Effects on Study Validity Links to useful websites for Chapter 10 Links to relevant open-access journal articles for Chapter 10

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 11

Specific Types of Quantitative

Research

a A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 11. (Puzzles may be removed for easier viewing.)

CHAPTER 11 ® Specific Types of Quantitative Research 71

ACROSS

ile

Interviews that are done when interviewers actually meet respondents are sometimes called interviews. Anise Os & ve outcome is one that improves if there is greater quantity or quality of patient care.

. A multiphase effort to refine and test the effectiveness of a clinical treatment (two words).

. Another term for interviews done in person is to interviews.

. An analysis of data done with an existing dataset.

. Surveys can be done by distributing

. An index called the quality-adjusted life _is an important outcome in cer- ionnaires through the mail.

tain cost analyses. . An impact analysis provides information about the effects of a program. . Ina clinical trial, the phase sometimes called effectiveness research.

ic research focuses on improving research strategies.

. An alternative to in-person interviews is interviews by __ _ ephone.

. Ina(n) _ _ _ inferiority trials, the researcher tests whether a new intervention is no

worse than a reference treatment (e.g., the standard of care).

. A(n) is an important method of collecting self-report data.

. A Phase II trial often involves a pilot of a new treatment.

. A method of interviewing in person with the aid of laptop computers is _ _ _ (acronym).

. In clinical trials, an efficacy study is the third :

. In evaluations, a(n) analysis describes the extent to which a program is achieving certain goals.

. The phase of a clinical trial that is an RCT.

. A Gallup poll is one of these.

. A(n) evaluation is a theory-driven approach to evaluation, seeking to

understand the theoretical mechanisms underlying intervention effects.

DOWN

iS)

Findings from evaluations, outcomes research, and technology assessments can be used in the formulation of public _ _ _ icies. A Phase III clinical trial is usually a(n) controlled trial.

Personal interviews are an expensive approach to surveys because they require a

___ of personnel time.

Data collected by asking people questions in a survey is via reports.

In the Donabedian framework, the three key factors are process, outcomes, and s_ _

One type of evaluation of the economic effects of an intervention (two words).

In a cost utility , QALY is often an important outcome.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

ART 3 a Designing and Conducting Quantitative Studies

8. An evaluation of the process of putting a new intervention into place is sometimes

called a(n) analysis. iz 9. Acronym for the type of research that involves comparisons of alternative

interventions. 14. A cost analysis of an intervention is sometimes called a(n) analysis.

15. Acronym for an important classification system of outcomes for nurses. 19. An example of a nursing-sensitive variable in outcomes research is

smoking cessation counseling.

20. Sometimes surveys can be administered over the Inter 24. Acronym for the type of evaluation that considers the effects of fechnological | inno-

vations in health care. 25. The type of evaluation that uses an experimental design to assess effectiveness is a(n)

analysis.

27. A survey technology that gives respondents privacy in answering questions is called

audio- . (acronym)

28. A complete clinical trial project might entail phases. 30. The Del __ _ technique involves multiple rounds of questioning to achieve

consensus.

= B.Study Questions

1. Suppose you were interested in studying the research questions below by conducting

a survey. For each, indicate whether you would recommend using a personal inter- view, a telephone interview, or a self-administered questionnaire to collect the data. What is your rationale?

a. What are the coping strategies of newly widowed individuals?

b. What strategies do emergency department nurses use to identify and correct med- ical errors?

c. What type of nursing communications do presurgical patients find most helpful?

d. What is the relationship between a teenager’s health-risk appraisal and his or her risk-taking behavior (e.g., smoking, unprotected sex, drug use, etc.)?

e. What are the health-promoting activities pursued by inner-city single mothers?

f. How is employment of parents affected by the health problems or disability of a child?

2. Suppose you were interested testing relaxing music as an intervention to reduce agi-

tation in nursing home residence. Describe how you might design a superiority trial

to test the intervention. Specifically, what would you use as the comparison group

strategy? Now suppose you wanted to test the intervention in an equivalence trial. What would your comparison group strategy be in this case?

CHAPTER 11 = Specific Types of Quantitative Research 73

3. Identify a nursing-sensitive outcome. Propose a research question that would use the outcome as the dependent variable. Would you consider the research to answer this question outcomes research?

4. Read the introduction and methods section of one of the following open-access jour- nal articles (links are provided on the Toolkit 9 for this chapter). Use the guidelines in Box 11.1 of the textbook (available as a Word document in the Toolkit 3) to

critically appraise the study:

* Kim, O., Kim, M., Kim, J., Lee, J., & Jung, H. (2018). Binge eating disorder

and depressive symptoms among females of child-bearing age: The Korea Nurses’ Health Study. BMC Psychiatry, 18, 13.

¢ Schmeer, K., Tarrence, J., Browning, C., Calder, C., Ford, J., & Boettner, B.

(2019). Family contexts and sleep during adolescence. SSM — Population Health, 7, 100520;

e Stoll, K., Hauck, Y., Downe, S., Payne, D., & Hall, W. (2017). Preference for

cesarean section in young nulligravid women in eight OECD countries and impli- cations for reproductive health education. Reproductive Health, 14, 116.

= C. Application Exercises

EXERCISE 1: STUDIES IN APPENDICES A, D, F, AND J

Which of the studies in the specified appendices of this Resource Manual (if any) could be considered:

a. A clinical trial? b. Outcomes research? c. Survey research? d. A needs assessment? e. A replication? f. A secondary analysis? g. Methodologic research?

EXERCISE 2: STUDY IN APPENDIX H

Read the first few sections (the sections before “Results”) of the article by Wilson and colleagues (“Individualized preoperative education”) in Appendix H. Then answer the

following questions:

Questions of Fact

a. Was this study a clinical trial or nursing intervention research? If yes, what phase

would this most likely be?

b. Was this study an evaluation? If yes, what type (process analysis, etc.)?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

eS On Ca '@

PART3 ® Designing and Conducting Quantitative Studies

. Was this outcomes research?

. Was this study a survey?

. Was this study an example of methodologic research?

. What is the basic research design for this study (i.e., experimental, quasiexperimental,

nonexperimental)?

Questions for Discussion

Comment on the adequacy and appropriateness of the use of various types of data in

this study. What are some of the uses to which the findings and product of this study could be put?

D. The Toolkit ee

For Chapter 11, the Toolkit G9 on thePoint’ contains a Word file with the following:

Some Guidelines for Critically Appraising Studies Described in Chapter 11 (Box 11.1 of the textbook)

Guidelines for Critically Appraising Cost/Economic Analyses Links to useful websites for Chapter 11

Links to websites with information about datasets for secondary analyses Links to relevant open-access journal articles for Chapter 11

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 12

Quality Improvement and

Improvement Science

gs A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 12. (Puzzles may be removed for easier viewing.)

y i 2 i Rey

) ee ae eal aan

ocala ie a a ed is a P

i ; i read

Generating and Assessing Evidence for Nursing Practice (11th ed.)

76 PART3 ®& Designing and Conducting Quantitative Studies

ACROSS

1. A(n) diagram can be used to document all potential causes of a prob-

lem, usually in four to six broad categories such as “People” and “Environment.”

4. Control , which are used to plot variation in an outcome over time, are a key feature of statistical process control analyses.

7. The overall of both quality improvement and research is to foster improve-

ments in health care.

. Acronym for a type of analysis used to identify the reasons that a problem exists.

. Inan FMEA analysis, the team asks such questions as: Why would the happen? What would be the consequences?

ihe. is an approach to probing for the underlying causes of a problem. science is the discipline devoted to systematic, rigorous efforts to

cultivate positive change in health care processes and outcomes. . A performance in a QI project usually assesses a process or an

outcome.

aie project (acronym) identified six core competencies for nurses; applying QI was one of the competencies.

. In PDSA cycles, the “P” stands for ;

. The acronym represents 5 activities that guide the PDSA cycles.

. The six goals identified in one of the reports by the Institute of Medicine are some-

times referred to by the acronym . The last phase in a PDSA cycle is to . In the acronym PDCA, sometimes used in en of PDSA, the “C” stands for . The second phase in a PDSA cycle is to . One of the core competencies for health care wiciesterels identified in an Institute for Medicine report is working in professional teams.

. In several QI models, the organization of appropriate from multiple rele- vant disciplines is a key early step.

lhe approach to QI involves efforts to eliminate waste, inefficiencies, and redundancies.

. One QI model is sometimes referred to as the Production System.

. The various reports produced by the Institute of Medicine are often referred to as the Quality reports.

DOWN

Als

The model (acronym) is designed to identify and prevent problems before they occur.

Acronym for a popular QI approach for analyzing data collected over an extended time period.

. Data for many QI projects are often retrieved from __ _s (acronym).

. Several tools used in QI initiatives are geared to understanding underlying of a problem.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 12 ®& Quality Improvement and Improvement Science 77

Nn . The “A” in the acronym FMEA stands for __ __ ysis.

6. The eighty- rule represents the expectation that about 80% of a problem is attributable to a small number of causes.

8. The PDSA process typically entails multiple cycles of activity. 9. One model for QI is called Six , which focuses on efforts to standardize

processes and reduce variation.

10. In seeking to identify fundamental causes of a problem, QI teams sometimes probe for why a problem occurs with up to successive questions.

12. The very first quality goal out of the six goals identified in an Institute of Medicine report was for health care that is ;

14. charts visually portray all the causes of a problem in descending order of occurrence.

15. One of the strongest quasi-experimental designs for QI projects is the design.

16. Advocates for strengthening QI initiatives often encourage teams to identify relevant theories of

18. The 80-20 is associated with Pareto charts. 19. The focus of this chapter was on (acronym).

20. The most widely used model for QI initiatives in health care is (acronym). 22. The PDSA model is almost never used in a single , but rather in several

rounds of improvements and testing.

24. Statistical control is one approach to analyzing data from a time series design.

26. Ina chart, an outcome of interest is plotted at multiple points before

and after a QI intervention. 28. An important quality improvement initiative for nursing, funded by the Robert

Wood Johnson Foundation is called __ _ B (acronym). 30. A quality management philosophy called inuous quality improvement

encourages ongoing scrutiny of quality. 31. Unlike a research study, a QI project typically does not require approval by an insti-

tution’s ___ (acronym) or ethics committee.

32. A(n) cause analysis involves efforts to understand fundamental causes of process or service deficiencies.

35. Acronym for a leading quality improvement organization in the United States.

= B. Study Questions

1. Below are a few potential problems that might arise in a health care setting. Select one and do a “5 Whys” analysis—even if you have to invent some of the answers.

a. High percentages of school-aged children in this community are obese and at high risk of diabetes.

b. Many patients with chronic pain are becoming addicted to opioids.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

78 PART3 © Designing and Conducting Quantitative Studies

c. The incidence of hospital-acquired pressure ulcers is rising. d. Patient satisfaction scores have been declining. is e. Nursing home residents are frequently missing their physical therapy

appointments.

. Use the template for a fishbone diagram provided in the Toolkit @ to identify multi-

ple causes for the problem selected in Exercise B.1.

. Read the Executive Summary of the Institute for Medicine’s (2001) Quality Chasm report (a link is provided in the accompanying Toolkit 9). Why do you think this report, and other IOM reports, played such a crucial role in galvanizing health care

disciplines, including nursing, into action?

. Read one of the following open-access journal articles (links are provided on the Toolkit @ for this chapter), each of which reports a quality improvement project in which nurses were involved. Use the guidelines in Box 12.1 of the textbook (avail- able as a Word document in the Toolkit 9) to critically appraise the study:

e Lia, Z. Zhao, Y., Liu D SGuowZ sin kiouns OG, ae Valle X> (2 Onl weltects

of nursing quality improvement on thrombolytic therapy for acute ischemic

stroke. Frontiers in Neurology, 9, 1025. e Spruce, K., & Butler, C. (2017). Enhancing outcomes for outpatient percutane-

ous coronary interventions. Clinical Nurse Specialist, 31, 319-328.

em Suimais Lins Or Zhaonl nang Ooex eke, Chenu... Liu, Y.(20n7).

Reducing waiting time and raising outpatient satisfaction in a Chinese public tertiary general hospital: An interrupted time series study. BMC Public Health, 17, 668.

e Williams, M., Sawchuk, C., Shippee, N., Somers, K., Berg, S., Mitchell, J.,

Mattson, A., & Katzelnick, D. (2018). A quality improvement project aimed at adapting primary care to ensure the delivery of evidence-based psychotherapy for adult anxiety. BM] Open Quality, 7, e000066.

C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX M

Read the article by Hountz and colleagues (“Increasing colorectal cancer screening”) in Appendix M. Then answer the following questions:

Questions of Fact

py {2tu(ey lop fs)

. What was the setting for this quality improvement (QI) project?

. Was the team interprofessional?

. What health care problem did the QI team decide to address?

. What were the goals of the project?

. Was the QI project approved by an ethics review committee?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

fi,

g. h.

i. j. k. I.

CHAPTER 12 ® Quality Improvement and Improvement Science 79

Did the team use one of the QI models described in the book? If yes, which one? Did the project involve multiple cycles? In planning the interventions to be tested, did the team perform a root cause analysis? Of the eight types of QI interventions described in the textbook, which did Hountz and colleagues implement? Were the interventions evidence-based?

What is the basic research design for this study? What were the outcome measures for this project? Were any qualitative data collected? Did the team conclude the interventions were successful?

Questions for Discussion

. Comment on the team’s use of staff input in this project. Comment on the interventions that were implemented. Can you think of others that the team might have tested?

. Did the team use the strongest possible study design? If not, what other designs might have strengthened the study’s internal validity?

. What other outcome measures could the team have used to evaluate the success of

the project? . How would you rate the overall rigor of this project? . In what other types of setting might it be possible to use the findings from this study?

D. The Toolkit eS

For Chapter 12, the Toolkit G9 on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising Quality Improvement Studies (Box 12.1 of the

textbook) Figure 12.2 from textbook: Template for a 5 Whys Analysis Alternative Worksheet for a Root Cause/S Whys Analysis Figure 12.3 from textbook: Template for a Fishbone Analysis Diagram

Example of a Completed Fishbone Diagram for a QI Project

Example of a Process Map from a QI Project Example of a PDSA Flow Chart from a QI Project Links to useful websites for Chapter 12 Links to relevant open-access journal articles for Chapter 12

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 13

Sampling in Quantitative

Research

a A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 13. (Puzzles may be removed for easier viewing.)

CHAPTER 13. & Sampling in Quantitative Research 81

ACROSS

Doel hes yess 5 | ible population is the population that is available to a researcher. 7. An aggregate set of individuals or objects with specified characteristics. 9. Larger samples are usually needed if there is an interest in studying _ _ _ group

. A sample is as

. When a population is

effects (i.e., studying people who can be classified into different groups, such as male/female).

of a specified population. . An effect size is an index that summarizes the _ | th of a relationship

between two variables.

. Criteria designating characteristics a population does mot have are__ sion

criteria.

. The most basic unit of a population.

. A distortion that occurs when a sample is not representative of the population is known as sampling

. A sampling approach in which elements are selected because of known attributes is called _ _ osive sampling.

. The bias arising when some potential respondents decline to participate is -response bias.

Sha atic sampling, every kth element is selected. . A type of sampling based on referrals from participants is sometimes called

sampling. . The specific attributes of a population are designated through eligibility . A strong sampling design can enhance the study’s value for evidence practice. . A sampling method involving referrals from other people already in the sample is

_ _ ball sampling. . In quantitative studies, the key criterion for evaluating a sample is whether it is

of the population. 2 ee ee ionate sampling involves sampling within strata mot in proportion to the size of the strata in the population.

eneous (i.e., variability is limited), smaller samples

may be sufficient.

DOWN

teh eg cutive sampling involves sampling every eligible case over a specified time

period.

2. A type of sampling within prespecified subgroups of the population, using nonprob-

ability sampling. . Subdivisions of a population.

. The most widely used type of sampling in quantitative research is__ _ _ _ _ ience

sampling.

. Large national surveys typically begin by sampling large (e.g., census

tracts) and then successively sampling smaller units.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

on.

PART3 ® Designing and Conducting Quantitative Studies

. Criteria that specify the characteristics that participants must have to be included in

the sample. ae . The rate of participation in a study is the ___ rate.

. Having too small a sample can affect a study’s statistical ___ _ _ usion validity.

alee eee eae ee ability sampling, not every element of a population has an equal

chance of being selected. mle (Sami pli gexec al is the standard distance between elements in a systematic

sample. analysis can be used by quantitative researchers to estimate the number

of participants needed in a quantitative study. . The total number of participants in a study is the sample . A probability sample involves selection of elements at ; . A stratified random sample is likely to be biased than a quota sample.

. When a high rate of _ _ ition from a study is anticipated, a larger sample may

need to be recruited.

. When disproportionate sampling is used,___ _ _ hting is necessary to arrive at esti-

mates of overall population values. A method called can be used to sample hidden populations, like the homeless (acronym).

= B. Study Questions

ISS)

. Draw a simple random sample of 15 people from the sampling frame of Table 13.3 of the textbook, using the table of random numbers that appears in Table 9.2. Begin

your selection by blindly placing your finger at some point on the table of random numbers.

. Suppose you have decided to use a systematic sampling design for a study. The known population size is 5,000, and the sample size desired is 250. What is the sampling interval? If the first element selected at random is 23, what would be the second, third, and fourth elements selected?

. Suppose you were interested in studying the attitude of clinical specialists toward autonomy in work situations. Suggest a possible target and accessible population. What strata might be identified if quota sampling were used?

. Identify the type of quantitative sampling design used in the following examples:

a. One hundred inmates randomly sampled from a random selection of five federal penitentiaries

b. All the oncology nurses participating in a continuing education seminar c. Every 20th patient admitted to the emergency room between January and

June

d. The first 20 male and the first 20 female patients admitted to the hospital with hypothermia

CHAPTER 13. ® Sampling in Quantitative Research 83

e. A sample of 250 members randomly selected from a roster of American Nurses Association members

f. 25 experts in critical care nursing, selected for their expertise and geographic distribution

g. All patients receiving treatment for asthma at a clinic over the past 12 months

5. Nurse A is planning to study the relationship between maternal stress, maternal depression, maternal age, and family economic resources on the one hand, and a

child’s socioemotional development on the other, among both two-parent and single parent families. Nurse B is planning to study body position on patients respiratory functioning. Describe the kinds of samples that the two nurses would need to recruit. Which nurse would need the larger sample? Defend your answer.

6. Read the introduction and methods section of one of the following articles. Use the guidelines in Box 13.1 of the textbook (available as a Word document in the Toolkit @) to critically appraise the sampling plan:

e *Cronly, J., Duff, A., Riekert, K., Perry, I., Fitzgerald, A., Horgan, A., ... Savage, E.

(2018). Online versus paper-based screening for depression and anxiety in adults with cystic fibrosis in Ireland. BM] Open, 8, e019305.

e *King, A., Boyd, M., Raphael, D., & Jull, A. (2018). The effect of a gerontology

nurse specialist for high needs older people in the community on healthcare utili-

zation. BMC Geriatrics, 18, 22.

e *Wittenberg, E., Ferrell, B., Kanter, E., & Buller, H. (2018). Health literacy:

Exploring nursing challenges to providing support and understanding. Clinical

Journal of Oncology Nursing, 22, 53-61.

a C. Application Exercises

EXERCISE 1: STUDIES IN APPENDICES A, C, D, H, AND J

Which of the studies in the selected appendices of this Resource Manual (if any) used:

a. A probability sample? b. A convenience sample? c. A quota sample?

* A link to this open-access journal article is provided in the Toolkit &.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

84 PART3 ® Designing and Conducting Quantitative Studies

EXERCISE 2: STUDY IN APPENDIX F |

Read the Methods sections of the article by Eckhardt and colleagues (“Fatigue in coro- nary heart disease”) in Appendix F. Then answer the following questions:

Questions of Fact

a. What was the target population of this study? How would you describe the accessible

population? b. What were the eligibility criteria for the study? c. Was the sampling method probability or nonprobability? What specific sampling

method was used? d. How were study participants recruited? e. What efforts did the researchers make to ensure a diverse (and hence more represen-

tative) sample? f. What was the sample size that the research team achieved? g. Was a power analysis used to determine sample size needs? If yes, what number of

subjects did the power analysis estimate as the minimum needed number?

Questions for Discussion

a. Comment on the adequacy of the researchers’ sampling plan and recruitment strat-

egy. How representative was the sample of the target population? What types of sam- pling biases might be of special concern?

b. Do you think the sample size was adequate? Why or why not?

= D. The Toolkit 5)

For Chapter 13, the Toolkit @9 on thePoint’ contains a Word file with the following:

e Guidelines for Critically Appraising Quantitative Sampling Plans (Box 13.1 of the textbook)

e Resources for Recruiting Study Participants e Links to useful websites for Chapter 13 e Links to relevant open-access journal articles for Chapter 13

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 14

Data Collection in Quantitative

Research

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 14. (Puzzles may be removed for easier viewing.)

an \

—]

Generating and Assessing Evidence for Nursing Practice (11th ed.)

86 PART3 ® Designing and Conducting Quantitative Studies

ACROSS

. The two options to “Did you smoke a cigarette today?” are “yes” and “no.

. One advantage of using questionnaires is the absence of any interviewer

In structured observation, a(n) is used with a category system to record the

incidence of observed events or behaviors. . A multi-item instrument that yields a score placing people on a continuum with

regard to an attribute. In observation studies, the instruments should be tested by having two or more _ _ _

ependent observers code or rate the event and then comparing results. One method of recording observations is to have observers use scales to

provide judgments about the behavioral construct along a continuum. . The type of question most prevalent in self-administered questionnaires (two words) . Respondents rate concepts on a series of bipolar rating scales in a(n)__ __ _ _ ic

differential.

. A description of a situation designed to elicit participants’ reactions or projections of how they would handle the situation.

. When response options are lengthy or complex, a(n) card is presented to

respondents in face-to-face interviews. . The tendency to distort self-report information in characteristic ways is a response

bias. ”

oo a =: iews tend to yield better quality data than self-administered questionnaires.

. One type of observational bias is the bias toward central , which distorts observations toward a middle ground.

. The error of occurs when observers characteristically rate things positively.

. A Likert-type scale is also referred to as a(n) ___ _ ated rating scale.

. The type of question that forces respondents to choose from two competing alterna- tives (two words).

DOWN

10;

A(n) ___ egory system is used to classify and organize observational events or occurrences.

A type of composite scale used to measure agreement or disagreement with statements. Extracting biophysiologic material from people yields __ vitro measures. On an agreement continuum, the most extreme negative response option (acronym). In Q-sorts, the objects being sorted are One advantage of questionnaires is that responses can be __ _ _ ymous, which is the best way to protect participants’ confidentiality. The type of observational sampling approach used to select periods when observa- tions are made.

The type of observational sampling involving integral episodes. A bias stemming from people’s wanting to “look good” is called a social bias.

ils):

16:

18.

20.

24.

2S:

28.

Mey.

oll

CHAPTER 14 a Data Collection in Quantitative Research 87

A questioning method to measure clinical symptoms along a 100 mm continuum is a analog scale.

A self-report approach involving the sorting of statements into different piles along a continuum.

On a five-point Likert scale, if SD were scored five, SA would be scored __. The error of occurs when observers characteristically rate things too harshly. Self-report instruments can be administered as ___-based surveys over the Internet. Filter questions often involve the use of patterns to route people appro- priately through a self-report instrument.

A rating scale along the continuum “exhausted” to “energized” is using adjectives.

If both positive and negative items were included in a scale, the researcher would need to the scoring of one type or the other before summing item scores. The question “What is it like to be a cancer survivor?” is ended. The most widely used method of data collection by nurse researchers is by ____ report. Many psychosocial scales are called _ tion of multiple items.

_ osite scales because they are a combina-

= B. Study Questions

le Suppose you were interested in studying adolescents’ attitudes toward risky behav- ior (e.g., unsafe sex, drug use, speeding). Develop the following types of questions designed to measure these attitudes.

a. A forced-choice item: b. A Likert-type item: c. An open-ended question:

. Below are hypothetical responses for Respondent Y and Respondent Z to the statements on the Likert scale presented in Table 14.2 of the textbook. What would the total score for both of these respondents be, using the scoring rules described in

Chapter 14?

Item No. Respondent Y Respondent Z

1 D SA

2 A D

3 SA D

4 A

5 D SA

6 SA D

TOTAL SCORE: ioee as

Generating and Assessing Evidence for Nursing Practice (11th ed.)

88 PART3 ®& Designing and Conducting Quantitative Studies

3. Below are hypothetical responses for Respondents A, B, C, and D to the Likert

statements presented in Table 14.2 of the text. Three of these four sets of responses

contain some indication of a possible response-set bias. Identify which three respon-

dents, and identify the types of bias.

eS ——

Item No. Respondent A Respondent B Respondent C Respondent D

1 A SA SD D

2 A SD SA SD

3 SA D SA D

4 A A SD SD

5 SA A SD SD

6 SA SD SA D

Bias:

4. Identify five constructs of clinical relevance that would be appropriate for measure- ment using a visual analog scale (VAS).

5. Suggest response alternatives for the following questions that might appear in a

questionnaire.

. Ina typical month, how frequently do you practice breast self-examination?

. When was the last time you had your blood pressure tested?

. What is your marital status? How would you rate the overall quality of your nursing education? How often do you skip breakfast? How important is it to you to avoid a pregnancy at this time? How many cigarettes do you smoke in a typical day?

. From which of the following sources have you learned about the dangers of smoking?

i. Which of the following statements best describes the physical pain you experi- enced during labor and delivery?

SM noo20 5

6. Hall administered a survey to high school students to learn about their eating pat- terns, particularly focusing on their consumption of high-fat foods. She distributed questionnaires accompanied by the cover letter that follows. Review and critique this cover letter, analyzing its tone, wording, and content.

Dear Student:

This questionnaire is part of a study to learn about some health-related issues

among high school students. Through this study we hope to have a better under- standing of young people in America. Students from 25 high schools in the United

States are being asked to help us in this effort. Your high school was selected at random.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 14 a Data Collection in Quantitative Research 89

Your responses to this questionnaire are completely anonymous. No one will know your answers, and so, even though some of the questions are personal, we hope that you will answer honestly. The quality of the picture we will have of high school students today depends on your willingness to provide thorough and candid answers.

Please answer every question. When you are through, please turn the questionnaire in to your homeroom teacher.

Your cooperation in completing this questionnaire is deeply appreciated.

Sincerely,

Elizabeth Hall, R.N.

7. Construct a VAS to measure fatigue. Administer the VAS two ways: (1) to yourself at 10 different times of the day and (2) to 10 different people at the same time of day. For the two types of administrations, is there similarity in scores or is there a wide range of responses? Which of the two yields scores with a wider range?

8. Below is a list of variables. Indicate briefly how you might operationalize each using structured observational procedures.

a. Fear in hospitalized children b. Pain during childbirth c. Dependency in psychiatric patients d. Agitation in nursing home residents

9. Three nurse researchers were collaborating on a study of the effect of preoperative visits to surgical patients by operating room nurses on the stress levels of those patients just before surgery. One researcher wanted to use the patients’ self-reports to measure stress; the second suggested using pulse rate and blood pressure; and the third recommended using an observational measure of stress. Which measure do you think would be the most appropriate for this research problem? Can you suggest other possible measures of stress that might be even more appropriate? Justify your

response.

10. Read the introduction and methods section of one of the following open-access arti- cles. Use the guidelines in Boxes 14.3 and 14.4 of the textbook (available as Word documents in the Toolkit 9) to critically appraise the data collection aspects of the

study:

e *Amiri, M., Sadeghi, T., & Nehahban-Bonabi, T. (2017). The effects of natural

sounds on the anxiety of patients undergoing coronary artery bypass graft sur-

gery. Perioperative Medicine, 6, 17.

e *Atkins, R. L. (2017). Outcomes of depression in black single mothers. Clinical

Nursing Research, 26, 464-483.

* A link to this open-access journal article is provided in the Toolkit @.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

90 PART3 ® Designing and Conducting Quantitative Studies

° “Blaser, R., & Berset, J. (2019). Setting matters: Associations of nurses’ attitudes

toward people with dementia. Nursing Open, 6, 155-16

e *Shen,X.,, Zhu, X... WU,eYn, ZROU,. Y.seX aes Lage Wane ra Yeu Z AO, Can 20113):

Effects of a psychological intervention programme on mental stress, coping style

and immune function in percutaneous coronary intervention patients. PLoS One,

TS EOUST 745%

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX C

Read the method section of the article by Yackel and colleagues (“Nurse-facilitated depression screening program”) in Appendix C. What types of data did the researchers collect in this EBP project? Comment on the data collection plan and the specific meth- ods used to collect data. What recommendations would you make for supplementary

data, keeping in mind the practical constraints of this practice project?

EXERCISE 2: STUDY IN APPENDIX D

Read the Method section of the article by Kim et al. (“Dietary approaches to stop hyper- tension”) in Appendix D. Then answer the following questions, focusing in particular on what the researchers did to collect data on program efficacy:

Questions of Fact

. Did this study collect any self-report data? What variables were captured by self-report?

. Were examples of specific questions included in the report?

. Were any composite scales used?

. Were self-report data gathered by interview or by self-administered questionnaires (or both)?

e. Did the report mention anything about the readability level of self-report instruments?

f. Did the researchers collect any data through observation? If no, could observation have been used to measure key concepts? If yes, what variables were measured through observation?

g. Did the researchers collect any biomarker data? If yes, what variables were measured through biomarkers?

h. Does the report describe the procedures for using biomarkers? Were procedures standardized?

i. Who gathered the data in this study? How were the data collectors trained?

aa FSF ®

*A link to this open-access journal article is provided in the Toolkit ©.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 14 a Data Collection in Quantitative Research 91

Questions for Discussion

Comment on the adequacy of the researchers’ description of their data collection approaches and procedures.

Do you think that Kim et al. operationalized their outcome measures in the best pos- sible manner? Could different or supplementary measures have been used to enhance the quality of the study’s evidence?

. Comment on the procedures used to collect data in this study. Were adequate steps taken to ensure the highest possible quality data?

D. The Toolkit 3

For Chapter 14, the Toolkit @9 on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising Data Collection Plans (Box 14.3 of the textbook)

Guidelines for Critically Appraising Structured Data Collection Methods (Box 14.4 of the textbook)

Data Collection Flow Chart Example of a Cover Letter for a Questionnaire (Figure 14.3 of the textbook) Example of a Visual Analog Scale Example of a Show Card for a Personal Interview Example of a Reminder Postcard for a Mailed Questionnaire Example of an Event History Calendar Example of a Table of Contents for an Interviewer Training Manual Model Sections for an Interviewer Training Manual

e Answering Respondents’ Questions e Avoiding Interviewer Bias ¢ Probing and Obtaining Full Responses

Annotated Guidelines Relating to Key Demographic Questions Example of a Basic Demographic Form for a Nursing Study Example of a Letter Requesting Permission to Use an Instrument

Links to useful websites for Chapter 14 Links to relevant open-access journal articles for Chapter 14

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 15

Measurement and Data Quality

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 15. (Puzzles may be removed for easier viewing.)

as i 26 27

2-2 eee a 28 29 30 LC ;

; Beane ; - - |

al CS 4 .

CHAPTER 15 & Measurement and Data Quality 93

ACROSS

. Predictive validity and concurrent validity are aspects of

. A receiver ___ _ _ ating curve can be used to determine the best dividing point for

. The type of validity involving the extent to which a measure “looks” valid.

. Sensitivity is plotted against 1-specificity in a(n) __

. The type of validity concerned with adequate representation of all facets of a con- curve (acronym).

cept’s domain.

ion validity.

cases and noncases in a screening instrument.

. Measurement involves assigning numbers according to established

. One index of measurement error is called the limits of ent.

. The acronym for the preferred index for estimating test-retest reliability.

. A single item designed to solicit information about a person’s degree of perceived change (acronym).

. One important reliability coefficient is called the class correlation coefficient.

. An index relating to specificity and sensitivity that captures proportion of area in an

ROC analysis (acronym). . A widely evaluated aspect of reliability for multi-item measures is called consistency.

. An evaluation of an instrument’s measurement properties is often called a(n)

assessment.

. To assess the stability of an instrument, it must be administered

. An index of the reliability of a change score (acronym).

. The purpose of a(n) is to obtain information to quantify an attribute or construct.

DOWN

2. The index summarizing experts’ judgments of a measure’s content validity

(acronym).

4. A(n) score is a person’s score difference between two measurements at

ores

10;

Malls

two points in time on the same measure.

Evidence that there is conceptual congruence between scores on a focal measure and scores on a measure of a related construct supports a type of construct validity

called validity. The difference between an obtained score and the true score is the of

measurement.

The score on a measure that would be obtained if the measure were infallible.

A measurement property that concerns the extent to which scores for people who

have not changed are the same for repeated measurements.

The type of reliability that concerns the stability of a measurement is —retest

reliability. An index of measurement error (acronym).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

12.

M7:

18.

JAY

Malle

Jaleo Zor

26. 23:

2°.

50: O22.

O3:

PART3 ® Designing and Conducting Quantitative Studies

The type of validity concerning translations and adaptations of instruments is

cultural validity. a A type of criterion validity in which the criterion is measured contemporaneously

with the focal measure is called validity.

Some multi-item measures are static and others are __ _ _ _ ive. Large banks make computerized adaptive testing possible. An index of the reliability of change scores often used by psychotherapists

(acronym). An instrument’s ability to identify a case correctly is its__§ __»§_ __ __ ity. A measurement property concerned with the extent to which an instrument mea-

sures what it purports to measure. A measurement property that concerns longitudinal validity is iveness. An index of measurement error that is derived from a Bland-Altman plot (acronym).

Some multi-item measures are formative indexes but most are__ _ _ _ ctive scales. An alternative theory to classical test theory (acronym). In screening instruments, “cases” are separated from “noncases” at the ___off point. The__ _ _ elation coefficient is an index used to summarize the magnitude and

direction of relationships between variables.

= B. Study Questions

Which of the following measures could not be assessed with respect to internal con- sistency? Why?

a. Infants’ Apgar scores (a formative index)

b. A 6-minute walk test c. A 10-item scale to measure resilience

d. A visual analog scale measuring dyspnea

Comment on the meaning and implications of the following statement:

A researcher found that the internal consistency of her 20-item scale measuring

attitudes toward nurse—midwives was .74, using the Cronbach alpha formula.

In the following situation, what might be some of the sources of measurement error?

One hundred nurses who worked in a large metropolitan hospital were asked to complete a 10-item Likert scale designed to measure job satisfaction. The question- naires were distributed by nursing supervisors at the end of shifts. The staff nurses were asked to complete the forms and return them immediately to their supervisors.

Identify what is incorrect about the following statements:

a. “My scale is highly reliable, so it must be valid.” b. “My instrument yielded an internal consistency coefficient of .80, so it must be

stable.” c. “My scale has good evidence of construct validity, therefore it must be responsive.”

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 15 ™& Measurement and Data Quality 95

d. “My scale had a reliability coefficient of .80. Therefore, an obtained score of 20 is indicative of a true score of 16.”

e. “The validation stud d th h idity.” t idation study proved that my measure has construct validity. f. “My advisor examined my new measure of dependence in nursing home residents

and, based on its content, assured me the measure was valid.” g. “My interrater reliability was alpha = .92.

. An instructor has developed an instrument to measure knowledge of research ter- minology. Do you think that more reliable measurements would be yielded before or after a year of instruction on research methodology, using the exact same test, or would there be no difference? Why?

. What types of groups might be useful for a known-groups approach to assessing construct validity for measures of the following:

. Emotional maturity

. Children’s aggressiveness

. Quality of life

. Compliance with a medication regimen

. Subjective pain oo 20 75 ©

. In the following situations, for which instrument or situation would reliability or internal consistency be expected to be higher, all else equal? Why?

a. An 8-item scale measuring self-efficacy or a 15-item scale of self-efficacy? b. A stress scale administered to patients just diagnosed with cancer, or the same

stress scale administered to people coming in for an annual health check-up? c. A test of nursing knowledge administered to freshmen nursing students or senior

nursing students?

. Read the introduction and methods section of one of the following reports, all of which are published as open-access articles (links are provided in the Toolkit @). Use the guidelines in Box 15.1 of the textbook (available as a Word document in the Toolkit @3) to critically appraise the measurement and data quality aspects of the

study:

e Holmberg Fagerlund, B., Helseth, S., Andersen, L., Smastuen, M., & Glavin, K.

(2019). Parental concerns of allergy and hypersensitivity and the infant’s diet.

Nursing Open, 6, 136-143. e ji, X., Cui, N., & Liu, J. (2017). Neurocognitive function is associated with

serum iron status in early adolescents. Biological Research for Nursing, 19,

269-277. e Park, K. H., & Song, M. R. (2017). The effects of postdischarge telephone coun-

seling and short message service on the knee function, activities of daily living, and life satisfaction of patients undergoing total knee replacement. Orthopedic

Nursing, 36, 229-236.

e Robaee, N., Atashzadeh-Shoorideh, F., Ashktorab, T., Baghestrani, A., &

Barkhordari-Sharifabad, M. (2018). Perceived organizational support and moral

distress among nurses. BMC Nursing, 17, 2.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

96 PART3 ® Designing and Conducting Quantitative Studies

a C. Application Exercise

Read the Method section of the article by Nyamathi and colleagues (“Achieving drug and alcohol abstinence”) in Appendix A. Then answer the following questions:

Questions of Fact

a. Which of the following types of data collection methods did the researchers use to

collect their data?

1. Extraction from records 2. Structured self-reports 3. Structured observations 4. Physical or biophysiological

b. For which specific measures were test-retest reliability coefficients reported? What were the values of the coefficients? What was the interval between the two testings?

c. For which specific measures were internal consistency coefficients reported? What were the values of the coefficients? Was internal consistency computed using data from the Nyamathi et al. study itself?

d. For which measures was validity information reported? What type of validity assess-

ment (if any) was reported (e.g., content validity, criterion validity, etc.)? e. Were measurement properties reported for any measures that were not self-reports?

f. Was information provided about measurement error for any measure? g. Was information reported about the reliability of change scores or the responsiveness

of any measures?

Questions for Discussion

a. Describe what some of the sources of measurement error might have been in this study. Did the researchers take adequate steps to minimize measurement error?

b. Comment on the adequacy of information in the report about efforts to select high- quality instruments.

c. Comment on the quality of the measures that Nyamathi and colleagues used in their study. Do you feel confident that instruments yielded high-quality measurements of the key constructs?

# D. The Toolkit G3

For Chapter 15, the Toolkit 9 on thePoint’ contains a Word file with the following:

¢ Guidelines for Critically Appraising Data Quality in Quantitative Studies (Box 15.1 of the textbook)

e¢ Summary Chart: Reliability and Measurement Error e Summary Chart: Validity

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 15 © Measurement and Data Quality 97

Illustration of a Bland-Altman Plot for Fictitious Self-Esteem Data Suggestions for Enhancing Data Quality and Minimizing Measurement Error in Quantitative Studies Links to useful websites for Chapter 15 Links to relevant open-access journal articles for Chapter 15

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 16

Developing and Testing

Self-Report Scales

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 16. (Puzzles may be removed for easier viewing.)

CHAPTER 16 ™ Developing and Testing Self-Report Scales 99

ACROSS

1 The type of factor analysis that does not stipulate an a priori hypothesis about the dimensionality of a set of items.

4. Factor rotation can be either orthogonal or : 8. One approach to cognitive questioning is called the aloud method. 9. In principal components analysis, a(n) is equal to the sum of squared

weights for a factor.

10. A(n) score involves the expression of a score in standard deviation

units, with the mean equal to 0.0. 12. Initially, it is best to develop 3-4 times as many as are believed to be needed

for a scale. 13. Ona Likert-type scale, each item consists of a declarative and a set of

response options.

17. Confirmatory factor analysis involves the testing of a measurement 18. In EPA, the first phase is called factor , 19. One index of readability is the Flesch reading score. 21. Likert-type scales often have five to seven == optrons. 23. A widely used factor extraction approach is called components

analysis. 25. The purpose of creating a scale is not to place respondents into a(n)

but rather to array them along a continuum. 27. The development of age-specific or gender-specific can help in inter-

preting scores on a measure. 29. A(n) analysis can be one source of items for a new scale.

30. In item response theory, items with different levels of ___ _ iculty are sought. Sil analysis is an empirical approach to understanding the dimensionality

of a set of items.

DOWN

1. In content validation work, a(n) ___ panel is established to review items.

2. One possible response continuum for bipolar items on a scale goes from never to

3. If there are negative and positive items on a unidimensional scale, some have to be

-scored., 5. The underlying construct in a scale is sometimes referred to as the ___ trait.

6. A major method of factor extraction is called principal-____ factor analysis.

7. Scale developers strive to create a multi-item scale that is internally consis __ _ _

11. In scale development within classical test theory, a(n) ___——_—s sampling model

is assumed, i.e., random sampling of items from a hypothetical universe.

12. For a traditional Likert-type scale, item ____ is usually similar across items.

14. In exploratory factor analysis, the second phase involves factor

15. In computing item-scale correlations, the ____ approach removes the item vtiea

the calculation of the total scale score.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

100 PART3 ® Designing and Conducting Quantitative Studies

16. During factor extraction, clusters of items that are intercorrelated are

identified. og 20. The type of factor analysis that does not have a priori hypotheses (acronym).

22. CFA is a subset of an advanced class of statistical techniques called__ _ _ _ _ ural

equation modeling. 245 Theeeee: pretability of scores refers to the degree to which one can assign quali-

tative meaning to the numeric values. 26. A good scale must be ____ __-dimensional and internally consistent. 28. Cutpoints on a scale can be established through a analysis (acronym).

= B. Study Questions

1. Below are 15 items that are intended to represent a first draft for a scale on atti- tudes toward mammography. Read the items and then do the following: (1) Make any revisions you think are appropriate to strengthen items and the overall scale, including deleting, replacing, or adding items; remember that the scale should be unidimensional—or there should be multiple subscales; (2) Indicate what response

options you would recommend for this scale; (3) Calculate what the possible range of responses would be on your revised scale; and (4) Order the items in a manner

you feel would be appropriate.

a. Having a mammogram will help me detect breast cancer early. b. If I find a lump early through a mammogram, I will have a better chance of

surviving breast cancer.

c. Having a mammogram is a good way to find a very small breast lump. d. Having a mammogram means I don’t have to bother with breast

self-examination. e. Having a mammogram will decrease my risk of dying from breast cancer. f. If [have a mammogram, I will be doing something to take care of myself. g. Lam afraid to have a mammogram because I might find out something bad. h. Having a mammogram would be embarrassing. i. L avoid having mammograms because they are painful. j. I just don’t have time for a mammogram.

k. Having a mammogram would expose me to unnecessary radiation. |. I can’t afford the expense of having a mammogram.

m. I have other health problems that are more important than getting a mammogram.

n. I don’t need to have a mammogram because no one in my family has had breast cancer.

o. Having a mammogram isn’t necessary for women who examine their own breasts.

2. Administer the revised “attitudes toward mammography” scale to a small pretest sample (10-15 women). Use cognitive questioning to help you better understand how the items are interpreted by respondents. Make revisions as appropriate. If others in your class have completed these two study questions, compare your scales.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 16 ® Developing and Testing Self-Report Scales 101

3. Go to the website for PROMIS®, the NIH initiative that created computerized adap- tive tests (using item response theory) for numerous important health outcomes. Take at least one of the tests. How many items were needed to score you? How did you compare to normed values for your age and gender? Here is the link: http://www.healthmeasures.net/explore-measurement-systems/promis.

4. Read the introduction, methods, and results sections of one of the following reports. Use the guidelines in Box 16.1 of the textbook (available as a Word document in the Toolkit G9) to critically appraise the study:

¢ *Price, C., Thompson, E., & Cheng, S. (2017). Scale of Body Connection: A multi-

sample construct validation study. PLoS One, 12, e0184757.

eyo Xtien |, Lilly Y.,oun, K., Wus L:, Liao, K.. Xia. Yeo.saishn Hla (20¢8)eiValidation

of a newly adapted Chinese version of the Newest Vital Sign instrument. PLoS Ovens, c0190721,

¢ *Zuriguel-Pérez, E., Falco-Pegueroles, A., Roldan-Merino, J., Agustino-

Rodriguez, S., Gomez-Martin, M., & Lluch-Canut, M. (2017). Development

and psychometric properties of the Nursing Critical Thinking in Clinical Practice Questionnaire. Worldviews on Evidence-Based Nursing, 14, 257-264.

= C. Application Exercises

E XERCISE 1: STUDY IN APPENDIX J

Read the report by the article by Caruso and colleagues (“The Cancer Worry Scale”) in Appendix J. Then answer the following questions:

Questions of Fact

—

. Did the researchers start “from scratch” in developing the Cancer Worry Scale- Revised for Breast Cancer Genetic Counseling (CWS-GC)?

How were items for the CWS-GC developed? . How many items were initially developed? How many items were on the final scale?

What were the response options for the items on the scale? . What do higher scores on the scale represent? . Was the readability of the items assessed? If yes, what was the reading level? . Was the instrument pretested with the target population? Was cognitive questioning

used? Was there a content validation effort for this scale? If so, was a CVI computed? What

was its value? What are the characteristics of sample members in the psychometric study? How

many people participated?

Did the researchers do an item analysis? If yes, what were the results?

* A link to this open-access article is provided in the Toolkit 54) :

Generating and Assessing Evidence for Nursing Practice (11th ed.)

102 PART3 ® Designing and Conducting Quantitative Studies

k. Was the internal consistency of the scale assessed? If yes, what was the value of the

alpha coefficient for the final version of the scale or subscales?

|. Was the test-retest reliability of the scale assessed? If yes, what was the time inter-

val between testings and who was in the sample? Was the intraclass correlation

coefficient used to estimate retest reliability? What was the value of the reliability

coefficient? m. Was exploratory factor analysis undertaken? Was confirmatory factor analysis per-

formed? If so, what were the findings? n. Was cross-cultural validity assessed?

. What other steps were taken to evaluate the validity of the scale? p. Was the responsiveness of the scale assessed? If yes, what hypotheses were tested,

and what were the findings?

Questions for Discussion

a. Comment on the adequacy of the scale development process. b. Comment on the sampling plan for the psychometric assessment, in terms of size,

sampling method, and sample heterogeneity. Overall, how adequate was the sample

that was used? c. How thorough do you think the researchers were in their efforts to assess the psycho-

metric properties of the instrument? What other types of evidence do you think the researchers should have collected?

d. How much confidence would you have in the CWS-GC instrument? Do you feel that the evidence supporting its high quality is persuasive?

EXERCISE 2: STUDY IN APPENDIX H

Read the description of the outcome measures used by Wilson and colleagues

(“Individualized preoperative education”) in Appendix H. Describe how one might go about assessing the reliability and validity of the six-item Brief Pain Inventory, Interference (BPI-I) scale. Would it be appropriate to assess: (1) test-retest reliability? (2)

internal consistency reliability? (3) criterion validity? (4) construct validity? What might be the impediments to such assessments?

= D. The Toolkit €3

For Chapter 16, the Toolkit @ on thePoint’ contains a Word file with the following:

¢ Guidelines for Critically Appraising Scale Development and Assessment Reports (Box 16.1 of textbook)

e Examples of Cognitive Questioning e Example of a Cover Letter for Expert Content Validity Panel e Example of a Content Validity Questionnaire

CHAPTER 16 ®& Developing and Testing Self-Report Scales 103

Example of a Query Letter for Commercial Publication of an Instrument Example of a Table of Contents for an Instrument Manual Links to Useful websites for Chapter 16 Links to relevant open-access journal articles for Chapter 16

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 17

Descriptive Statistics

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 17. (Puzzles may be removed for easier viewing.)

—_ nN w eS nn nan a eo

ie oe | Eo

birt i “EE

26 Et ;

a :

| ‘ E LO ST

CHAPTER 17. = Descriptive Statistics 105

ACROSS

ilk

Me),

OM. oon

Frequency distributions that have a peak in the center and each half mirrors the other are Intercorrelations among key variables are frequently displayed in a correlation

A(n) distribution is a widely observed unimodal, symmetric distribution that is not too peaked or too flat.

. The ratio of two probabilities (the probability of an event occurring to the probabil- ity that it will not occur) is the ratio.

. Distributions whose peaks are “off center.”

. A correlation index for ordinal-level data.

. Each variable can be described in terms of its of measurement, which affects

appropriate mathematic operations.

. Acommon risk index—the simple proportion of people who experienced an unde- sirable outcome (acronym).

. The most common correlation index: the Pearson product correlation coefficient.

. Interval measures provide no information about magnitude.

. Interval- and ratio-level data are sometimes referred to as uous data.

. A way to display a bivariate distribution is in a(n) table.

. In nominal measurement, the or value used to code a variable has no

inherent quantitative meaning.

. A measure of central tendency indicating the most “popular” value.

. The number needed to is an estimate of how many people would need to receive an intervention to prevent an undesirable outcome.

When the tail of a frequency distribution points to the left, the skew is An index of central tendency that indicates the midpoint of a distribution (abbr.). An index of a sample is a statistic; an index of a population is a(n)

DOWN

NARWN PD

The most frequently used index of variability or dispersion (acronym).

There are four levels of ! A crude index of variability—the highest value minus the lowest. Relationships between two variables can be described through procedures. The sum of all data values, divided by the number of cases. The level of measurement in which distances between values are equal, but there is

no rational zero. A bar over this is used as a symbol for the mean.

. The mean is the most commonly used index of central

. Measurements that involve rank-ordering are __ _ dinal level measurements.

. The standard deviation squared. The highest level of measurement.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

106 PART3 ® Designing and Conducting Quantitative Studies to Generate Evidence

18. In lay terms, the average. 19. One type of graphic display of frequency distribution data. ~ 21. A distribution of data can be described by its shape, tendency, and

variability. 22. The variable gender is measured on this level. 24. Bivariate relationships can be graphed on a plot.

25. A distribution that has two peaks. 30. Another name for a bell-shaped curve is a__ _ _ sian distribution. 32. A commonly reported risk index, concerning odds (acronym).

= B. Study Questions

1. For each of the following variables, specify the highest possible level of measurement

that you think a researcher could attain.

. Attitudes toward the mentally handicapped ___

. Birth order

. Length of time in labor ___

. White blood cell count ___

Race/ethnicity ___

. Tidal volume ___

~Deerees Celsius . Country of birth ____

. Scores on a fear of death scale ___

. Amount of sputum ___

2. Prepare a frequency distribution and histogram for the following set of data values, which represent the ages of 30 women receiving estrogen replacement therapy:

47-50 51 50 48 51 50 51 49 51 54549 498) 9 SA 52 S165 2 S03 49S 1 S2-5109.055 48 5453.52.

Describe the resulting distribution in terms of its symmetry and modality.

3. Calculate the mean, median, and mode for the following pulse rates:

78 84 69 98 102 72 87 75 79 84 88 84 83 71 73

Mean: Median: Mode:

4. Suppose a researcher has conducted a study concerning lactose intolerance in young children. The data reveal that 12 boys and 16 girls have lactose intolerance, out of a sample of 60 children of each gender (120 total). Construct a contingency table. What percentage of boys, girls, and the overall sample were lactose intolerant? What percentage of children who were lactose intolerant were female?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER17. ® _ Descriptive Statistics 107

5. Ask 25 friends, classmates, or colleagues the following four questions:

¢ How many brothers and sisters do you have?

¢ How many children do you expect to have in total? ¢ Would you describe your family during your childhood as “close” or “not very

close”? ¢ On your 14th birthday, were you living with both biologic parents, primarily

with one biologic parent, or with neither biologic parent?

When you have gathered your data, calculate and present several statistics that describe the information you obtained.

6. Suppose that 400 people (200 per group) participated in the intervention study described in connection with Table 17.6 in the textbook, and that 120 of those in

the experimental group and 180 of those in the control group continued smoking

3 months after the intervention. Compute the various risk indexes in this scenario.

7. Read one of the following open-access research reports and use the guidelines in Box 17.1 (available as a Word document in the Toolkit for this chapter) to critically appraise the researchers’ use and presentation of descriptive statistics, ignoring at this point discussions of inferential statistics and statistical tests:

@ *Atakul, E., & Akyar, I. (2019). Frailty prevalence and characteristics in older

adults with hematologic cancer: A descriptive study. Asia-Pacific Journal of Oncology Nursing, 6, 43-49.

e *Davison, K., Holloway, C., Gondara, L., & Harcher, A. (2018). Independent

associations and effect modification between lifetime substance use and recent

mood disorder diagnosis with household food insecurity. PLoS One, 13,

e0191072.

e¢ *Garmy, P., Clausson, E., Nyberg, P., & Jakobsson, U. (2018). Insufficient sleep

is associated with obesity and excessive screen time amongst ten-year-old children

in Sweden. Journal of Pediatric Nursing, 39, e1-eS.

e *Taneja, C., Netsch, D., Rolstad, B., Inglese, G., Lamerato, L., & Oster, G.

(2017). Clinical and economic burden of peristomal skin complications in

patients with recent ostomies. Journal of Wound, Ostomy, & Continence

Nursing, 44, 350-367.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX F

Read the Results section of the article by Eckhardt and colleagues (“Fatigue in the pres-

ence of coronary heart disease”) in Appendix F. Then answer the following questions:

*A link to this open-access journal article is provided in the Toolkit @.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

108 PART3 ® Designing and Conducting Quantitative Studies to Generate Evidence

Questions of Fact

a. Did Eckhardt and her colleagues present descriptive statistics describing characteris- tics of the sample? If yes, where were they presented, in the table or in the text?

b. Referring to Table 1:

¢ Which variables, if any, were measured as: a nominal-level variable? an ordinal-

level variable? an interval-level variable? a ratio-level variable? e State in one sentence what the “typical” participant was like demographically,

based on information in Table 1. e According to Table 1, what percentage of the total sample had a graduate degree?

What percentage of men and what percentage of women, had clinically meaning-

ful fatigue? c. Referring to Table 2, answer the following questions (ignore the columns with the

heading of “p”):

e Which descriptive statistics are presented in this table? e¢ Which variable was most strongly associated with fatigue intensity scores? ¢ Were better educated people more likely or less likely to have high fatigue

intensity?

Questions for Discussion

a. Discuss the effectiveness of the presentation of information in the tables. What, if

anything, could be done to make the tables more informative, more comprehensible, or more efficient? Should there have been other tables?

b. Did Eckhardt and colleagues use the appropriate statistics to describe their data? For example, did the statistics correspond to the levels of measurement of the variables? Could additional descriptive statistics been used to more fully describe the data?

EXERCISE 2: STUDY IN APPENDIX H

Read the Results section of the article by Wilson and colleagues (“Individualized preop- erative education”) in Appendix H. Then answer the following questions:

Questions of Fact

a. Did Wilson and her colleagues present descriptive statistics that described characteris- tics of the sample? If yes, where were they presented, in the table or in the text?

b. Referring to Tables 2 through 5, answer the following questions:

1. Which variables described in the tables, if any, was measured as : a nominal- level variable? an ordinal-level variable? an interval-level variable? a ratio-level variable?

2. What was the sample size for this study? 3. Which descriptive statistics mentioned in Chapter 17 are presented in these four

tables?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER17 #® Descriptive Statistics 109

4. What was the mean pain score for the two groups on postoperative day 3 for the variable “worst pain in last 24 hours”?

5. What was the median amount of opioid analgesics administered to the two groups on the first postoperative day?

Questions for Discussion

ib Discuss the effectiveness of the presentation of information in the tables. What, if anything, could be done to make the tables more informative, more comprehensible, or more efficient? Should there have been other tables?

. Did Wilson and colleagues use the appropriate statistics to describe their data? For example, did the statistics correspond to the levels of measurement of the variables? Could additional descriptive statistics been used to more fully describe the data?

D. The Toolkit 3

For Chapter 17, the Toolkit GY on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising Descriptive Statistics (Box 17.1 of the textbook) Table Templates for Presenting Descriptive Statistics

¢ Table Template 1: Sample Description Table ¢ Table Template 2: Crosstabs Table ¢ Table Template 3: Correlation Matrix Links to useful websites for Chapter 17 Links to relevant open-access journal articles for Chapter 17

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 18

inferential Statistics

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 18. (Puzzles may be removed for easier viewing.)

CHAPTER 18 #® Inferential Statistics 111

ACROSS

1. A(n) interval indicates degree of precision in parameter estimation. 8. One of the two broad approaches in statistical inference is hypothesis

10. The probability of committing a type II error is called

12. Data from a design with multiple measurements of a continuous variable would likely be analyzed using a(n) -measures ANOVA.

13. In statistical testing, the error that reflects a false negative is a Type ____ error. 14. A nonparametric analog to a t-test is the -Whitney U test. 16. A test comparing the means of three groups is a -way analysis of variance.

17. An ES index for ANOVA situations is the squared. 19> The error of the mean is the SD of a theoretical distribution of means. 23. A Bonferroni correction involves a correction to the criterion, to reflect

multiple tests with the same data. 2S5cal he region of a theoretical distribution indicates whether the null

hypothesis is improbable. 26. The test most often used when a hypothesis concerns differences in proportions is

the square test. 27. When sample sizes are very small, Fisher’s test should be used to test differ-

ences in proportions.

29. In statistical testing, an alpha of .0S is a standard criterion of statistical 31. A(n) analysis can be used during the planning of a study to estimate sam-

ple size needs. 36. If the computer indicated that p = .15, this would indicate the relationship being

tested was (acronym).

37. Even though researchers often have directional hypotheses, they most often report the results of - tests.

39. In statistical testing, a false positive is a(n) ___——_error. 40. A sampling is theoretical, not based on actual data values. 41. Most statistical yses for nursing studies involve inferential statistics.

DOWN

2. If both tails of the sampling distribution are not used to test the null hypothesis, the testis called ___-tailed.

3. The statistic computed in analysis of variance. 4. Eachrstatistical analysis is associated with certain ___ of freedom that usually

reflect sample size. 5. The class of statistics that does not have restrictive assumptions about how variables

are distributed.

6. Analpha of .01 is a more stringent ___ of significance than an alpha of .05.

7. For dichotomous variables, the sampling distribution is called a(n)

distribution. 9, In ANOVA, the overall mean for an entire sample, with all groups combined, is the

__d mean.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

112 PART3 #® Designing and Conducting Quantitative Studies to Generate Evidence

10. An independent group statistical test is used for -subjects designs. 11. With ordinal data, one correlation index is Kendall’s ist

15. When the null hypothesis is not rejected, results are sometimes described as

18. The analysis used to compare 3+ group means (acronym). 20. The number of observations free to vary about a parameter (acronym). 21. An extension of a paired t-test to three time periods would call for ___-ANOVA

(acronym). 22. In a repeated measures analysis, the within-subjects analysis effect involves a time

24. An index describing the relationship between two dichotomous variables. 27. In an analysis of crosstabs table data, observed frequencies are contrasted with

frequencies. 28. The nonparametric analog of a paired t-test is the Wilcoxon -rank test. SORA meee eee ificant result indicates that the null hypothesis cannot be rejected.

32. Cohen’s d is a(n) size index in a 2-group mean difference situation. 33. The simplest type of multifactor ANOVA is a -way ANOVA. 34. Differences in two group means can be tested using a(n) __- ; 35. The following might be the information for a 95% ___: (—1.25, .78).

38. In hypothesis testing, researchers typically seek to reject the hypothesis.

= B. Study Questions

1. A research team measured the amount of time (in minutes) spent in recreational

activities by a sample of 200 hospitalized paraplegic patients. They compared male and female patients, as well as those 50 years of age and younger versus those over 50 years of age. The four group means were as follows:

Age Male Female

<50 98.2 (n = 50) 70.1 (n= 50)

>50 50.8 (n = 50) 68.3 (n = 50)

A two-way ANOVA yielded the following results:

F df P

Gender 3.61 LAS 105

Age group 5.87 1,196 <.05

Gender x age group 6.96 1,196 <.01

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 18 # Inferential Statistics 113

Discuss the meaning of these results.

. The correlation between the number of days absent per year and annual salary ina sample of 100 employees of an insurance company was found to be —.23 (p = .02) Discuss this result in terms of significance level and meaning.

. Indicate which statistical test(s) you would use to analyze data for the following variables:

a. Variable 1 = psychiatric patients’ marital status; variable 2 = whether or not the patient has attempted suicide in the past 12 months.

b. Variable 1 = participation versus nonparticipation of patients with a pulmonary embolus in a special treatment group; variable 2 = pH of the patients’ arterial blood gases.

c. Variable 1 = serum creatinine concentration levels; variable 2 = daily urine output.

d. Variable 1 = the number of patients’ comorbidities (0, 1, or 2+); variable 2

= patients’ degrees of self-reported depression on a 30-item depression scale.

Correlations

SF12:

SF12: Physical Mental

Number of Health Health

Doctor Visits, Body Mass Component Component

past12mo Index Score Score

Number of doctor Pearson 1.000 mills —.316° —.133° visits, past 12 mo Correlation

Sig. (2-tailed) .000 .000 .000

N Sey 967 890 890

Body mass index Pearson Pisis 1.000 —,134? —.078° Correlation

Sig. (2-tailed) .000 .000 .022

N 967 970 866 866

SF12: Physical Health Pearson —.316° —.134° 1.000 .168°

Component Score correlation

sig. (2-tailed) .000 .000 .000

N 890 866 893 893

SF12: Mental Health Pearson =i er = O78. 168° 1.000 Component Score correlation

sig. (2-tailed) .000 .022 .000

N 890 866 893 893

“Correlation is significant at the 0.01 level (2-tailed).

Correlation is significant at the 0.05 level (2-tailed).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

114 PART3 © Designing and Conducting Quantitative Studies to Generate Evidence

4. On the previous page is a correlation matrix produced in SPSS, based on real data from a study of low-income mothers. If you have familiarity with SPSS (e.g., if you

have read the Chapter Supplement on the book’s website), answer the following questions with respect to this matrix:

a. How many young mothers completed the SF-12 scale? b. What is the correlation between body mass index (BMI) and scores on the SF-

physical health subscale? c. Is the correlation between SF-physical health and SF-mental health subscale

scores significant at conventional levels? d. What is the probability that the correlation between BMI and number of doctor

visits in the previous year is simply a function of chance? e. With which variable(s) is BMI related at the .01 level of significance?

f. Explain what the correlation between the SF-physical and SF-mental health scale scores means.

5. Below is a list of variables. Assume that you have data from 500 nurses on these variables. Develop two or three hypotheses regarding the relationships among these variables and indicate which statistical tests you would use to test your hypotheses.

¢ Number of years of nursing experience e Type of employment setting (hospital, nursing school, public school system,

other)

e Salary

e Marital status (never married; currently married; divorced or separated;

widowed)

¢ Job satisfaction (dissatisfied; neither dissatisfied nor satisfied; or satisfied) ¢ Number of children under 18 years of age ¢ Gender (male, female, other)

e Intent to remain in nursing in next 12 months (from 0, highly unlikely to 10, definitely)

6. Estimate the required total sample sizes for the following situations:

a. Comparison of two group means: « = .05; power = .90; ES = .35.

b. Correlation of two variables: « = .05; power = .80; P = .20.

7. Read one of the following articles and use the guidelines in Box 18.1 (available as a Word document in the Toolkit for this chapter) to critically appraise the research- ers’ analyses, ignoring at this point discussions of multivariate statistics such as multiple regression:

¢ *Hornik, B., Dulawa, J., Szewieczek, J., & Durmala, J. (2019). Physical activity increases the resistin concentration in hemodialyzed patients with metabolic syn- drome. Diabetes, Metabolic Syndrome and Obesity, 12, 43-57.

*A link to this open-access journal article is provided in the Toolkit G.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 18 #® Inferential Statistics 115

¢ *Shariatkhah, J., Farajzadeh, Z., & Khazaee, L. (2017). The effects of cognitive- behavioral stress management on nurses’ job stress. Iranian Journal of Nursing and Midwifery Research, 22, 398-402.

e *Tieman, J., Miller-Lewis, L., Rawlings, D., Parker, D., & Sanderson, C. (2018). The contribution of a MOOC to community discussions around death and dying. BMC Palliative Care, 17, 31.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

Read the Methods and Results sections of the article by Nyamathi and colleagues (“Achieving drug and alcohol abstinence”) in Appendix A. Then answer the following questions:

Questions of Fact

Did the report indicate that a power analysis had been done during the planning of the study to estimate sample size needs? If yes, what power criterion was used? Did the report indicate that Nyamathi and colleagues analyzed the preintervention

comparability of participants in the intervention and control groups? If yes, what sta- tistical tests were used? Was a rationale for the choice of statistic offered? Were any group differences statistically significant? Was there any attrition in this study? If yes, were the rates similar in the intervention and control group? Was an attrition bias analysis performed?

. Referring to the text and to Table 2, did the researchers undertake any within-group analyses with respect to key outcomes? What statistical tests were used? Were any

changes statistically significant? Referring to the text and to Table 2, did the researchers undertake between-group analyses? What statistical tests were used? Were any group differences statistically

significant?

Questions for Discussion

Comment on the researchers’ choice of statistical analyses in this study. Comment on the effectiveness of presenting information in Table 2. What, if any- thing, might be done to make the table more informative, more comprehensible, or

more efficient?

* A link to this open-access journal article is provided in the Toolkit €.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

116 PART3 ® Designing and Conducting Quantitative Studies to Generate Evidence

EXERCISE 2: STUDY IN APPENDIX D he

Read the Results section of the article by Kim and colleagues (“Dietary approaches to stop hypertension”) in Appendix D. Then answer the following questions:

Questions of Fact

a. Which bivariate statistical tests discussed in Chapter 18 did Kim and colleagues use

in their analyses presented in Table 4? b. What is the independent variable in the analyses presented in Table 4? What are the

dependent variables? c. What was the purpose of the tests presented in Table 4? d. Are the actual test statistics (e.g., t, x7) presented in Table 4? Were they reported in

the text? e. Overall, how many tests in Table 4 were statistically significant at conventional

levels? f. Did the report indicate that a power analysis was done while planning the study to

estimate sample size needs? g. What would the effect size estimate be for the ascorbic acid measure—using baseline

and 10-week values?

Questions for Discussion

a. Discuss the effectiveness of the presentation of information in Table 4. What, if any- thing, could be done to make this table more informative, more comprehensible, or more efficient?

b. Did Kim and colleagues use the appropriate statistical tests to analyze their data? If not, what tests should have been performed?

c. Did the researchers present a sufficient amount of information about their statistical tests? What additional information would have been helpful?

= D. The Toolkit 54)

For Chapter 18, the Toolkit @9 on thePoint’ contains a Word file with the following:

¢ Guidelines for Critically Appraising Bivariate Inferential Statistics (Box 18.1 of the textbook)

¢ Table Templates for Selected Bivariate Analyses

e Table Template 1A: Independent Groups t-Tests e Table Template 1B: Independent Groups t-Tests (Alternative format) ¢ Table Template 2: Paired t-Tests ¢ Table Template 3: One-Way ANOVA

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER18 #® Inferential Statistics 117

¢ Table Template 4A: Chi-Squared Tests (For 2-Group Comparisons) ¢ Table Template 4A: Chi-Squared Tests (For 2+ Group Comparisons) ¢ Table Template 5: Correlation Results

¢ Links to useful websites for Chapter 18 e Links to relevant open-access journal articles for Chapter 18

CHAPTER 19

Multivariate Statistics

= A. Crossword Puzzie

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 19. (Puzzles may be removed for easier viewing.)

= a

La nN nN

= a

| -

i ; Nn _

CHAPTER19 ® Multivariate Statistics 119

ACROSS

ile Analyses to test causal pathways with nonexperimental data often use modeling with equations.

6. OLS is an acronym for an estimation procedure in which the “O” stands for

8. Multiple regression uses a(n) squares criterion to solve equations.

11. A(n) model is one in which the flow of causation is presumed to be in one direction.

13. A key index in logistic regression is the ratio. 14. Another name for a z-score is a(n) score.

20. In ANCOVA, the variables that are statistically controlled are DD ne generar model (GLM) is a broad class of procedures that

encompasses ANOVA and multiple regression. 23. A(n) of prediction almost always occurs in regression, because correla-

tions between predictors and outcome variables are not perfect. 24. An alternative to OLS estimation is likelihood estimation (MLE).

26. In logistic regression, the statistic is used to test the significance of individ- ual predictors.

28. Causal models can be tested using analysis. 30. The likelihood ratio test in logistic regression is sometimes called a goodness of

test.

31. Logistic regression uses a different procedure than OLS multiple regres- sion, called MLE for short.

32. ANCOVA can yield information about means—i.e., means after removing the effects of covariates.

33. In regression analyses, an independent variable is often called a(n) variable.

DOWN

1. A regression approach that uses a statistical criterion to enter predictors into the model.

2. Error terms in regression are sometimes called the 3. When multicollinearity is present, the results tend to be uns__ _ _ _

4, When the dependent variable is dichotomous, the most common approach is to use regression analysis.

5. The analysis used to compare groups when there are 2+ dependent variables and confounders need to be controlled (acronym).

7. When RM-ANOVA is used to compare experimental and control group subjects at multiple points in time, it is the __ _ _ raction that is of greatest interest.

Oe Leek statistic indicates the proportion of variance of a dependent vari-

able explained by all predictors (abbr.)

NOE dita —Lemeshow test is one approach to testing an overall logistic regres-

sion model.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

120

ii,

16.

18. 1:

29.

26.

Dale

29:

PART3 Designing and Conducting Quantitative Studies to Generate Evidence

The class of statistical analysis involving multiple variables is called multi_____ _ _

statistics. = A least-squares approach to making predictions about categorical dependent

variables is analysis, which has been superseded by logistic regression

analysis. An approach to regression that involves entry of predictors in a researcher-

determined sequence is called __ _ _ archical regression.

Regression analysis that predicts a continuous outcome with at least two predictors

is called regression. Acronym for a key statistical index in logistic regression. Simple regression involves predictor variable. A statistical procedure for testing causal models that estimates parameters using

MLE (acronym).

A group can be adjusted to reflect net effects after statistically controlling

one or more covariates. A standardized regression coefficient is called a beta A dichotomous variable coded as 1 versus 0, used in regression analyses, is called a

variable. RM-ANOVA for designs is used to test hypotheses about differences in group means measured at multiple times.

a B. Study Questions

Al Examine the correlation matrix below and explain the various entries. Explain why

the multiple correlation coefficient (R) between the predictor variables B through E, and the dependent variable Satisfaction with Nursing Care (variable A), is .54—i.e.,

not much larger than some of the bivariate correlations. What is the R* for the cor- relation between Satisfaction with Nursing Care and the predictors? What does this mean?

A B C D E

Satisfaction with Age Depression _ Length of Educational

Nursing Care Scores Stay Level

Variable A 1.00

VariableB = —.26 1.00

VariableC -—.48 .29 1.00

VariableD —.19 e272. .68 1.00

Variable E 10 —.07 —.17 —.24 1.00

CHAPTER 19 ® Multivariate Statistics 121

2. In the following examples, which multivariate procedure is most appropriate for analyzing the data?

a. A researcher is testing the effect of verbal expressiveness, self-esteem, age, and the availability of family supports among a group of recently discharged psychiatric patients on recidivism (i.e., whether they will be readmitted within 12 months after discharge).

b. A researcher is comparing the bereavement and coping processes (as measured on an interval-level scale) of recently widowed versus recently divorced individuals, controlling for their age and length of marriage.

c. A researcher wants to test the effects of (a) two-drug treatments and (b) two dos-

ages of each drug on (a) blood pressure and (b) the pH and Po, levels of arterial blood gases.

d. A researcher wants to predict hospital staff absentee rates based on month of the year, staff rank, shift, number of years with the hospital, and marital status.

e. A researcher wants to test the effects of two alternative diets on blood sugar lev- els measured at baseline and then 1, 3, and 6 months later.

3. Below is a list of variables that a nurse researcher might be interested in predicting. For each, suggest at least three independent variables that could be used in a multi- ple regression analysis.

a. Amount of time spent exercising weekly among teenagers: b. Nurses’ frequency of administering pain medication:

. Body mass index (a common measure of obesity):

. Patients’ level of fatigue:

. Anxiety levels of prostatectomy patients: a0

(o)

4. In their 2001 study, Wang, Redeker, Moreyra, and Diamond (Clinical Nursing

Research, 10, 29-38) used a series of t-tests and chi-squared tests to compare two groups of patients who underwent cardiac catheterization: those with 4 hours versus those with 6 hours of bed rest. The groups were compared on several outcomes, including measures of safety, comfort, and satisfaction. Identify two or three multi-

variate procedures that could have been used to analyze the data, being as specific as possible (e.g., if you suggest ANCOVA, identify appropriate covariates).

5. Read one of the following studies and use the critical appraisal guidelines for sta- tistical analysis in Box 18.1 of the textbook (available as a Word document in the Toolkit @ for the Chapter 18) to evaluate the multivariate statistical analyses:

e¢ *Chou, F. Y. (2019). Cancer illness perception and self-management of Chinese

patients. Asia-Pacific Journal of Oncology Nursing, 6, 57-63. e Ford, J., Pomykacz, C., McCabe, S., & Boyd, C. (2018). Sports involvement,

injury history, and non-medical use of prescription opiods among college stu-

dents: An analysis with a national sample. American Journal of Addiction, 27,

15-22.

* A link to this open-access article is provided in the Toolkit ©.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

122 PART3. ® Designing and Conducting Quantitative Studies to Generate Evidence

° *McBain, J., Lamontagne-Godwin, F., Haddad, M., Simpson, A., Chapman, J.,

Jones, J., Flood, C., & Mulligan, K. (2018). Management of type 2 diabetes

mellitus in people with severe mental illness: An online cross-sectional survey of

healthcare professionals. BMJ Open, 8, e019400.

° “Veale, J., Peter, T., Travers, R., Saewyc, E. (2017). Enacted stigma, mental

health, and protective factors among transgender youth in Canada. Transgender

Health, 2, 207-216.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

Read the Methods (Data analysis) and Results section of the article by Nyamathi and

colleagues (“Achieving Drug and Alcohol Abstinence”) in Appendix A. Then answer the

following questions:

Questions of Fact

a. Were any multivariate analyses described in Chapter 19 undertaken in this study? If

yes, which ones? b. What were the independent and dependent variables in the multivariate analyses? c. What approach to entering variables into the model did Nyamathi and colleagues use

in their supplementary analysis? d. Which, if any, of their results for the primary and secondary outcomes were statisti-

cally significant in their main analyses of group differences?

e. In Table 3, there is no information for the Mental Health Index in the column for

multivariate results. Why do you think this was so?

Questions for Discussion

a. Comment on the researchers’ strategy for entering variables into the model whose results are represented in Table 3. Would you recommend an alternative approach?

b. Were there other multivariate analyses that the researchers could have used but did not? Would you recommend the use of such analyses? Why or why not?

c. Comment on the possible implications of the study’s sample size for the study findings.

EXERCISE 2: STUDY IN APPENDIX F

Read the Methods (Quantitative analysis) and Results section of the article by Eckhardt

and colleagues (“Fatigue in coronary heart disease”) in Appendix F. Then answer the following questions:

*A link to this open-access article is provided in the Toolkit @.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 19 #® Multivariate Statistics 123

Questions of Fact

a. Were any multivariate analyses described in Chapter 19 undertaken in this study? If yes, which ones?

. What were the independent and dependent variables in the multivariate analyses?

. What approach to entering variables into the model did Eckhardt and colleagues use in this study?

Which, if any, of their results were statistically significant, in terms of individual inde- pendent variables?

. What was the value of R* in their analyses? Were these values statistically significant?

. Did Tables 3 and 4 provide information that could be used by others to predict the dependent variable?

. Did the authors assess the risk of multicollinearity for their regression analysis? If yes, what did they conclude?

Questions for Discussion

Comment on the researchers’ strategy for entering variables into the model. Would you recommend an alternative approach? Were there other multivariate analyses that the researchers could have used but did not? Would you recommend the use of such analyses? Why or why not?

. Comment on the possible implications of the study’s sample size for the study findings.

= D. The Toolkit 6

For Chapter 19, the Toolkit G9 on thePoint’ contains a Word file with the following:

e Table Templates for Presenting Selected Multivariate Statistics

Table Template 1: Template for Simultaneous Multiple Regression Table Template 2: Template for Hierarchical Multiple Regression Table Template 3: Template for ANCOVA Table Template 4: Template for Mixed-Design RM-ANCOVA

e Table Template 5: Template for Logistic Regression e Links to useful websites for Chapter 19 e Links to relevant open-access journal articles for Chapter 19

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 20 ~

Processes of Quantitative Data

Analysis

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 20. (Puzzles may be removed for easier viewing.)

CHAPTER 20 #® Processes of Quantitative Data Analysis 125

ACROSS

[o-e)

30.

. The deletion of cases with missing data on an analysis-by-analysis basis.

. For studies with a crossover design, it is useful to assess whether there is any order- ing (or carryover)

. Coding decisions are Asean ina

. When sample extends over a long ed of time, tests for cohort effects (changes in sample characteristics) may be advisable.

. The least desirable pattern of missingness, in which the value of the missing infor- mation is correlated with its being missing (acronym).

. When items on a scale for a participant have missing values, mean substitu- tion involves using the mean item score for that person on other items on the scale.

maximization is an imputation method that uses a maximum- likelihood-based algorithm to produce estimates of missing values.

. Data cleaning includes checks, which examine whether there are any contradictions in the data within individual cases.

. Before the principal analyses are undertaken, researchers should test for various types of , such as attrition and selection.

. Considered the “gold standard” imputation method (acronym).

. To test for the robustness of results, researchers sometimes undertake

analyses. . Each case in a data set should be assigned a(n) number.

. A coded value that is impossible within the coding scheme is a(n) code.

. Refusals and skipped questions require values codes.

. A(n) _ effect occurs when score values are clustered at the upper end

of a continuum. An extreme value outside the normal range is called a(n)

DOWN

When there are multiple sites, it is useful to test whether across sites is

appropriate. One broad missing values strategy involves the of values to estimate those that are missing. A(n) effect can occur if there is insufficient room for variation in low scores. Researchers often need to do a data to get values into a form appropri- ate for analysis or to address nonnormal distributions. One method of imputing a missing value is to use conditional substitu- tion for a relevant subgroup.

deletion is sometimes called complete case analysis.

. An early in the data analysis process is to clean the data. Acronym for the imputation approach that pools several estimates of the missing value. In preparing to compute scale values, a procedure called reversal is some- times necessary to ensure scoring in a consistent direction

Generating and Assessing Evidence for Nursing Practice (11th ed.)

126

Mpc

24. 26;

28. 29.

PART3 © Designing and Conducting Quantitative Studies to Generate Evidence

Sometimes a transformation involves creating a dummy ___ _ _ iable for multivariate

analysis. An imputation method that imputes a missing outcome as the previously measured

value of the same outcome (acronym). A useful tool for planning analyses is the creation of a table

The recommended approach to analyzing data from a clinical trial, en every-

one who is randomized is analyzed (acronym).

One criterion for extreme outliers is whether a value is more than three times the

(acronym).

One strategy for resolving missing values is to use mean stitution.

The entire collection of data for a study is called a data

= B. Study Questions

ip Read the following study, and (1) indicate which steps in the process shown in Figure 20.1 were described in the report and (2) comment on whether the absence of other information affected the quality of the research evidence: McDaniel, J.,

Ahijevych, K., & Belury, M. (2010). Effect of n-3 oral supplements on the n-6/n-3

ratio in young adults. Western Journal of Nursing Research, 32, 64-80.

. Read the following study, which involved some data transformations. Comment on the researchers’ decision to use transformations and the results that were achieved:

Deresz, L., Schodler, C., de Bittencourt, P., Karsten, M., Ikeda, M., Sonza, A., &-Dal

Lago, P. (2018). Exercise training reduces oxidative stress in people living with HIV/ AIDS. HIV Clinical Trials, 19, 152-157.

. Read one of the following studies and evaluate the extent to which the research-

ers assessed or addressed possible biases. Comment on the thoroughness of the researchers’ efforts.

e Hagan, T., Belcher, $., & Donovan, H. (2017). Mind the mode: Differences in

paper vs. web-based survey modes among women with cancer. Journal of Pain & Symptom Management, 54, 368-375.

e *Kahsay, H., Gashe, F., & Ayele, W. (2018). Risk factors for hypertensive dis-

orders of pregnancy among mothers in Tigray region, Ethiopia: Matched case- control study. BMC Pregnancy and Childbirth, 18, 482.

e “Lim, Soohie bho... Ytes., Kaok., Wang.) .6aku0, |x 20 IalwAnxicty

and depression in patients with traumatic spinal cord injury: A nationwide population-based cohort study. PLoS One, 12, e0169623.

¢ Toth, M., Holmes, M., Van Houtven, C., Toles, M., Weinberger, M., & Silberman, P. (2017). Rural-urban differences in the effect of follow-up care on postdischarge outcomes. Health Services Research, 52, 1473-1493.

*A link to this open-access article is provided in the Toolkit ©.

CHAPTER 20 Processes of Quantitative Data Analysis 127

4. Read the following study, and comment on the efforts the researchers made to address data quality issues: Maxwell, C. A., Mion, L. C., Dietrich, M., Fallon, W., & Minnick, A. (2014). Hospitals’ adoption of targeted cognitive and functional status quality indicators for vulnerable elders. Journal of Nursing Care Quality, 29, 354-362.

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

Read the “Method” and “Results” sections of the article by Nyamathi and colleagues (“Achieving drug and alcohol abstinence”) in Appendix A. Then answer the following questions.

Questions of Fact

a. Did the researchers indicate which software was used to perform their analyses? b. Did the report indicate that tests were performed to assess the degree to which the

data met assumptions for parametric tests? . Did any study participants withdraw from the study? What was the rate of attrition

in the two groups? d. Did the report provide information about how missing values were handled? e. Was the analysis an intention-to-treat analysis? f. Was a sensitivity analysis conducted in this study?

Questions for Discussion

Discuss the thoroughness of the researchers’ description about their analytic and data

management strategies.

EXERCISE 2: STUDY IN APPENDIX F

Read the “Methods” and “Results” sections of the article by Eckhardt and colleagues (“Fatigue in coronary heart disease”) in Appendix F. Then answer the following questions.

Questions of Fact

a. Did the researchers indicate which software was used to perform their analyses? b. Did the report indicate that tests were performed to assess the degree to which the

data met assumptions for parametric tests such as multiple regression?

c. Did the report provide information about how much missing data there were, and

how missing values were handled?

d. Did the report discuss any data transformations? If yes, what were they?

e. Was a sensitivity analysis conducted in this study?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

128 PART3 ® Designing and Conducting Quantitative Studies to Generate Evidence

Questions for Discussion

Discuss the thoroughness of the researchers’ description about their analytic and data

management strategy.

= D. The Toolkit 5K)

For Chapter 20, the Toolkit @ on thePoint’ contains a Word file with the following:

¢ Data Transformations for Distribution Problems * Case Mean Substitution for Missing Values on Multi-Item Scales ¢ Useful websites for Chapter 20 e Links to relevant open-access journal articles for Chapter 20

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 21

Clinical Significance and

Interpretation of Quantitative

Results

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 21. (Puzzles may be removed for easier viewing.)

ss a bee

eee | |

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

130 PART3 ® Designing and Conducting Quantitative Studies to Generate Evidence

ACROSS |

2a line significance of research results is their practical importance to patients’ daily lives or to health-care decision-making.

4. When some hypotheses are upheld and others are not, results are said to be 6. A patient who attains a clinically significant change can be classified as a(n)

8. Acronym for a widely used benchmark for individual-level clinical significance. 9. Benchmarks for clinical significance are most often established for change scores for

faa? em al patients. 11. One index that can be used to assess group-level clinical significance (acronym). 12. Interpretations of results should take into account various _ _ _ ses and threats to

validity. 152An95% is often used in interpreting group-level significance. 16. One view of clinical significance concerns the degree to which a person with initial

poor functioning can achieve a(n) state through treatment or intervention.

18. A threshold equal to 0.5 SD is an example of a(n) approach to estab- lishing important change.

21. In interpreting results, an important research maxim is that correlation does not

DLOVe see = ee n. 24. Researchers’ interpretations of their results appear inthe__ _§ _ = ion section of

a report. 25. The “C” in the acronym MIC stands for 26. After drawing conclusions about the accuracy of their ancines researchers need to

interpret what they —especially with regard to casual connections.

27. ane change index is one approach to coming to conclusions about whether a person’s change score reflects real change.

DOWN

1. One aspect of interpreting results concerns the of the estimates of effects, usually captured through confidence intervals.

2. The first step in doing an interpretation usually involves coming to a conclusion about the of the findings.

3. After interpreting their results, researchers usually present at least one for using their findings in real-world applications.

4. A widely used threshold for clinical significance is the important change for an outcome measure.

5. When researchers hypothesize that one intervention is not superior to another inter- vention, they may design a(n) trial.

7. For group-level analysis, a commonly used index of clinical significance is a(n) size index.

10. In interpreting results, researchers must make to operationalize study constructs.

. See ences about the proxies used

14.

172

20.

Jajbg

MBX

CHAPTER 21 # Clinical Significance and Interpretation of Quantitative Results 131

A global rating scale is often used as a criterion in -based approaches to establishing clinically meaningful thresholds. Researchers are in a good position to know about any study , and should note this in a report. The approach (acronym) is a two-step process for determining a clini- cally meaningful change. Researchers establish a(n)__ = | rk for outcome measures that represents a threshold for clinical significance for a score or change scores. A traditional approach to setting a benchmark for a health outcome is to obtain input froma us panel of experts.

When a result is _ _ _ significant, the results are ambiguous—it does not constitute evidence that the null hypothesis is correct.

A benchmark for the MIC that is sometimes used is 1(one) (acronym).

= B. Study Questions

i Read one of the following studies, which considered clinical significance. Were the researchers referring to clinical significance at the group-level or at the level of indi- vidual patients? Comment on their interpretation of clinical significance in relation to the textbook’s explanation:

e Chen, L., Chen, Y., Chen, X., Wang, Q., & Sun, C. (2018). Longitudinal study

of effectiveness of a patient-centered self-management empowerment intervention during predischarge planning on stroke survivors. Worldviews on Evidecne-Based Nursing, 15, 197-205.

¢ Toye, C., Parsons, R., Slatyer, S., Aoun, S., Moorin, R., Osseiran-Moisson, R.,

& Hill, K. (2016). Outcomes for family carers of a nurse-delivered hospital

discharge intervention for older people (the Further Enabling Care at Home Program): Single blind randomised trial. International Journal of Nursing Studies, 64, 32-41.

. Read one of the following articles, paying particular attention to the Discussion. Use the guidelines in Box 21.1 of the textbook (available as a Word document in the Toolkit 9) to critically appraise the Discussion section:

e *Abrahamson, K., Hass, Z., & Sands, L. (2017). Likelihood that expectations

of informal care will be met at onset of caregiving need: A retrospective study of older adults in the USA. BMJ Open, 7(12), e017791.

e *Heckel, L., Fennell, K., Reynolds, J., Boltong, A., Botti, M., Osborne, R., ...

Livingston, P. (2018). Efficacy of a telephone outcall program to reduce caregiver burden among caregivers of cancer patients [PROTECT] A randomised controlled

trial. BMC Cancer, 18, 59.

“A link to this open-access journal article is provided in the Toolkit @.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

132 PART3 ® Designing and Conducting Quantitative Studies to Generate Evidence

e Tanner, L. R., & Hooke, M. (2019). Improving body function and minimizing

activity limitations in pediatric leukemia survivors. Pediatric Blood & Cancer,

66(5);627596: ¢ Wallace, D., Sawyer, A., & Shafazand, S. (2018). Comorbid insomnia symptoms

predict lower 6-month adherence to CPAP in US veterans with obstructive sleep

apnea. Sleep & Breathing, 22, 5-15.

3. Skim one of the following articles, the titles for which imply a causal connection between phenomena. Do you think a causal inference is warranted—why or why

not?

e Albdour, M., Hong, J., Lewin, L., & Yarandi, H. (2019). The impact of cyberbul-

lying on physical and psychological health of Arab American adolescents. Journal of Immigrant and Minority.Health, 21(4), 706-715.

¢ Gasior, S., Forchuk, C., & Regan, S. (2018). Youth homelessness: The impact of

supportive relationships on recovery. Canadian Journal of Nursing Research, 50,

28-36.

e *Jeon, G., Choi, K., & Cho, S. (2017). Impact of living alone on depressive symp-

toms in older Korean widows. International Journal of Environmental Research & Public Health, 14, (10), E1191.

e *Lambert, S., Bowe, S., Livingston, P., Heckel, L., Cook, S., Kowal, P., & Orellana,

L. (2017). Impact of informal caregiving on older adults’ physical and mental health in low-income and middle-income countries. BMJ Open, 7(11), e€017236.

4. Read a recent article in a high-quality nursing research journal. Did the researchers discuss clinical significance? If yes, did they define what they meant, conceptually

and operationally? Was it a group-level or individual-level interpretation? If no men- tion was made about clinical significance, was this absence noteworthy in terms of understanding the importance of the results for clinical practice?

= C. Application Exercises

EXERCISE C1: STUDY IN APPENDIX A

Read the “Results,” and “Discussion” sections of the report by Nyamathi and colleagues (“Achieving drug and alcohol abstinence”) in Appendix A. Then answer the following questions:

Questions of Fact

a. Did the researchers provide evidence about the success of randomization—i.e., whether participants in the Dialectical Behavioral Therapy-Case Management group and those in the Health Promotion group were equivalent at the outset and, thus, selection biases were absent?

“A link to this open-access journal article is provided in the Toolkit &.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 21. ® _— Clinical Significance and Interpretation of Quantitative Results 133

. Did the researchers report an analysis of attrition biases? Was attrition taken into account in the analysis of group differences on the outcomes?

. With regard to the primary aim of the study, to compare group outcomes on rates of drug and alcohol abstinence after participating in the two interventions, were hypoth- eses supported, nonsupported, or mixed?

. Did the report provide information about the precision of results via confidence intervals?

. Did the report provide information about magnitude of effects via calculation of effect sizes?

. In the Discussion section, was there any explicit discussion about the study’s internal validity?

. In the Discussion section, was there any explicit discussion about the study’s generalizability?

. Did the Discussion section discuss any implications of the study?

. Did the Discussion section explicitly mention any study limitations?

. Did the Discussion section explicitly mention clinical significance?

Questions for Discussion

eRe tom 6)

. Do you agree with the researchers’ interpretations of their results? Why or why not?

. Discuss the extent to which the Discussion addressed key results.

. What is your assessment of the internal and external validity of the study?

. To what extent do you think the researchers adequately described the study’s limita- tions and strengths?

EXERCISE C2: STUDY IN APPENDIX D

Read the Results and Discussion section of the report by Kim and colleagues (“Dietary

approaches to stop hypertension”) in Appendix D. Comment on the authors’ use of the

term “clinically significant.”

= D. The Toolkit e3

For Chapter 21, the Toolkit G9 on the accompanying CD-ROM contains a Word file

with the following:

e Supplementary Table of Research Biases e Examples of MIC Benchmarks for Health Measures

e Useful websites for Chapter 21

¢ Links to open-access journal articles relevant to Chapter 21

Generating and Assessing Evidence for Nursing Practice (11th ed.)

: Aenea , Mena ecu: > 2 a easy e~

eationtiens x eliorye its el tea eal wr exo EV? woh =a

e “Beh wh A 2 Sone yr re ae

ate esters half cn *490k —— poms Sai —

— Gd init Sata ack Te a soo POMS oils | ee . a sek

—— ) vere > se Oe. a> Jee =—T ; 4 ee ee re fre ee « SPFoy= ana aS

eT Puuyeretrsiy Hee ID eed Se ey Reise ede | has elias anit tor a6 ‘eunbua aleng Weesrrtnn 2.) wiley ait” hanieresasemyt qoinaa sabe syne

° ‘€ a a’ cost a mii, “Ine nina vai je —— ree

Tare tilooT ont x |

0 rele ag will sgt”

ee bes ane lh a nl en

| is aime ty ia avy) einmagea vixen qoPesallabing © nan ea gece ft Sah oe, mall se re . . wrest ine Im ald | aye * * 7

cvean dt he ;

a - - a :

Ter? of 1) lise Vr 1) ” : Y on AyT 9! fe po Tatts a ‘-

Designing and

Conducting Qualitative Studies to Generate Evidence for Nursing

CHAPTER 22

Qualitative Research Design and

Approaches

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 22. (Puzzles may be removed for easier viewing.)

‘ Gay ia eee i

S 4 Sal oI

CHAPTER 22 ™ Qualitative Research Design and Approaches 137

ACROSS

1, Ethnographers enlist the help of key to help them understand a culture. 3. A case study design can be either a(n) or multiple case design. 8. Leininger’s phrase for research at the interface between culture and nursing.

10. The type of phenomenology that includes the step of bracketing is__ _ _ riptive. 12. Another term for auto-ethnography is research. 13. Research that focuses on gender domination.

as . The perspective that is the insider’s view.

@velyare she ogical psychology focuses on the environment’s influence on behavior. . One of the two originators of grounded theory. . A type of action research (acronym).

. Knowledge that is so embedded in a culture that people do not talk about it. ce ee, pretive phenomenology is sometimes called hermeneutics. . The perspective that is the outsider’s view. . Qualitative researchers’ ability to derive information from a wide array of sources and use a variety of methods.

. Traditional qualitative research does not adopt a strong political or logical perspective.

. Qualitative research design decisions typically unfold while researchers are in the

. A(n) __ _ _ ormance ethnography is a staged re-enactment of an ethnographic interpretation of a culture.

. Qualitative research design is typically a(n) design that evolves during the

course of the study.

wie Ly ts £4 tive analysis focuses on story as the object of inquiry. The acronym for a psychological approach to phenomenology that focuses on a

person’s lifeworld.

ANG) BeINOSH nt be relationships. In a cross-sectional qualitative study, data are collected from each study participant

only Phenomenologists study people’s experiences.

__ network analysis focuses on people’s pattern of

research is the systematic collection and analysis of materials relating to

the past. analysis is used to understand the rules and structure of conversations. etive phenomenology focusing on the meaning of experiences.

. The second step in descriptive phenomenology is to in__ __.

. A phenomenological question is: What is the

wburkeon . Research that involves a critique of society is based on theory.

eee ee ce of this phenomenon?

_ adic dramatism is one approach to narrative analysis.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

138

ath

PES.

25.

26.

lle

PBS

PART4 ™ Designing and Conducting Qualitative Studies to Generate Evidence

One approach to classifying qualitative research design is according to a qualitative

ene ion. =

A hermeneutic is a process of understanding the whole of a text from

its parts, and the parts from the whole.

Ethnographic research originated in the discipline of anthrop___ __ ;

Qualitative researchers often maintain a(n) ive journal to record their

own presuppositions and biases.

Qualitative designs typically are involve an intervention.

The phenomenological concept -in-the-world acknowledges people’s

physical ties to their world.

experimental—i.e., they do not usually

= B. Study Questions

i For each of the research questions below, indicate what type of qualitative research tradition would likely guide the inquiry, and explain why you think that would be

the case.

a. What is the social psychological process through which couples deal with the

sudden loss of an infant through SIDS? b. How does the culture of a suicide survivors’ self-help group adapt to a successful

suicide attempt by a former member? c. What is the lived experience of the spousal caretaker of a patient with

Alzheimer’s disease?

. Skim the following two studies, which are examples of ethnographic and phenom-

enologic studies. What were the central phenomena under investigation? Compare and contrast the methods used in these two studies (e.g., how were data collected?

How many study participants were there? To what extent did the design unfold while the researchers were in the field?)

¢ Ethnographic Study: Cooke, H. A. (2018). Staff personhood in dementia care set- tings: “Do they care about me?” International Journal of Older People Nursing, 135e12184.

e Phenomenologic Study: Farrar, H., Kulig, J., & Sullivan-Wilson, J. (2018). Older

adult caregiving in an Amish community. Research in Gerontological Nursing, 11938.

. Skim the following article about a participatory action research (PAR) study and

comment on the roles of participants and researchers. How might the study have been different if a participatory approach had not been used?

¢ Canham, S., Fang, M., Battersby, L., Woolrych, R., Sixsmith, J., Ren, T.,

& Sixsmith, A. (2018). Contextual factors in aging well: Creating socially engaging spaces through the use of deliberative dialogues. Gerontologist, 58, 140-148.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 22. Qualitative Research Design and Approaches 139

4. Read the following open-access article describing a case study and evaluate the extent to which a case study approach was appropriate. What were the drawbacks and benefits of using this approach?

¢ *Wong-Cornall, C., Parsons, J., Sheridan, N., Kenealy, T., & Peckham, A. (2017). Extending “continuity of care” to include the contribution of family car- ers. International Journal of Integrated Care, 17, 11.

5. Read the following open-access article describing a grounded theory study and

evaluate the extent to which the problem was well-suited to the grounded theory research tradition. Which of the schools of grounded theory thought was followed in this study? Does the report explicitly discuss how the constant comparative method was used?

e *Renolen, A., Hoye, S., Hjalmhult, E., Danbolt, L., & Kirkevold, M. (2018).

“Keeping on track”—Hospital nurses’ struggles with maintaining work flow while seeking to integrate evidence-based practice into their daily work:

A grounded theory study. International Journal of Nursing Studies, 77, 179-188.

6. Read one of the following open-access research reports and use the guidelines in Box 22.1 (available in the Toolkit @) to critically appraise the design of the study:

e *Azevedo, M., Oliveira, I., Souza, T., Moraes, J., Martinez, E., & Araujo, B.

(2018). Empowerment of the mothers of children in pediatric intensive care unit.

Revista Brasileira de Enfermagem, 71, 3. e *Lambert, J., Etsane, E., Bergh, A., Pattinson, R., & van den Broek, N. (2018).

“T thought they were going to handle me like a queen but they didn’t”: A quali- tative study exploring the quality of care provided to women at the time of birth.

Midwifery, 62, 256-263. e *Salifu, D., Gross, J., Salifu, M., & Ninnoni, J. (2019). Experiences and percep-

tions of the theory-practice gap in nursing in a resource-constrained setting: A

qualitative description study. Nursing Open, 6, 72-83.

7. Read one of the studies below and think about how the researcher could have

adopted a critical theory or feminist perspective. In what way would the methods

for such a modification differ from the methods used?

¢ *Guruge, S., Sidani, S., Illesinghe, V., Younes, R., Bukhari, H., Altenberg, J., ...

Fredericks, $. (2018). Healthcare needs and health service utilization by Syrian

refugee women in Toronto. Conflict and Health, 12, 46.

e Pathike, W., O’Brien, A., & Hunter, S. (2019). Moving on from adversity: An

understanding of resilience in rural Thai older people. Aging & Mental Health,

23(3), 311-318.

* A link to this open-access article is available in the Toolkit 3 for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

140 PART4 © Designing and Conducting Qualitative Studies to Generate Evidence

obese pregnant women: Qualitative findings. Clinical Nursing Specialist, 32, 81-89.

e Yeager, K., Quest, T., Vena, C., & Sterk, C. (2018). Living with symptoms: A

qualitative study of black adults with advanced cancer living in poverty. Pain

Management Nursing, 19, 34-4S.

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX E

Read the Methods section of the report by Cummings (“Sharing a traumatic event”) in Appendix E. Then answer the following questions:

Questions of Fact

a. In which tradition was this study based? Within which specific school of inquiry was the study based?

. What is the central phenomenon under study?

. Was the study longitudinal? What was the setting for this research? Did the researcher make explicit comparisons?

. Did the researcher use methods that were congruent with the qualitative research tradition?

g. Did this study have an ideological perspective?

moans

Questions for Discussion

a. How well is the research design described? Were design decisions explained and justified?

b. Does it appear that the researcher made all design decisions up-front, or did the design emerge during data collection, allowing researchers to capitalize on early information?

c. Could this study have been undertaken within an ideological perspective? Why or why not?

EXERCISE 2: STUDY IN APPENDIX G

Read the Methodology section of the report by Byrne and colleagues (“Care transition experiences”) in Appendix G. Then answer the following questions:

Questions of Fact

a. In which tradition was this study based? b. Which specific approach was used—that of Glaser and Strauss, Strauss and Corbin,

or Charmaz?

SM wooo

—_s

CHAPTER 22 & Qualitative Research Design and Approaches 141

What is the central phenomenon under study? . Was the study longitudinal? . What was the setting for this research? . Did the report indicate or suggest that constant comparison was used?

. Was a core variable or basic social process identified? If yes, what was it?

. Did the researchers use methods that were congruent with the qualitative research tradition?

. Did this study have an ideological perspective? If so, which one?

Questions for Discussion

How well is the research design described in the report? Were design decisions explained and justified? Does it appear that the researchers made all design decisions up-front, or did the design emerge during data collection, allowing them to capitalize on early information? Were there any elements of the design or methods that appear to be more appropriate for a qualitative tradition other than the one the researchers identified as the underly- ing tradition? Could this study have been undertaken within an ideological framework? If so, what changes to the research methods would be necessary?

D. The Toolkit 54)

For Chapter 22, the Toolkit GY on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising Qualitative Designs (Box 22.1 of the textbook) Chang’s (2016) Evaluative Questions for Autoethnographers Links to useful websites for Chapter 22 Links to relevant open-access journal articles for Chapter 22

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 23

Sampling in Qualitative Research

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 23. (Puzzles may be removed for easier viewing.)

142

Emm aes es

nN —]

CHAPTER 23. ™ Sampling in Qualitative Research 143

ACROSS

3: Rely Tee atory case sampling involves gaining access to a case representing a phe- nomenon previously inaccessible to scrutiny.

6. A widely used purposive sampling approach is maximum sampling. 7. Sampling confirming or disconfirming cases usually occurs toward the of

data collection. 11. The type of sampling preferred by grounded theory researchers. 12. Selecting people who are below average, average, and above average is an example

ofies agsan ified purposive sampling. 13. In phenomenological research, the number of participants is often Or so. 15. Another name for snowball sampling is __ sampling. 17. The symbol < stands for this (acronym). 18. The lower the quality of the qualitative , the larger the sample usually

must be. 19. Qualitative researchers often use a(n) approach to sampling, selecting

specific types of participants who can maximize information richness. 21. One of two models of generalization that has relevance for qualitative researchers. De (or disconfirming) cases are sometimes sampled as a means of challeng-

ing researchers’ interpretations.

2: is a criterion of Morse for assessing a qualitative sampling strategy that

concerns the sufficiency and quality of data the sample yielded. 24. Analytic involves efforts to go from particulars of the sample and the

data to a broader theory or conceptualization.

DOWN

IRs aeee rion sampling involves selecting cases that meet a predetermined specifica-

tion of importance. Deming (eS. Piri Or eous sampling, diversity is deliberately reduced to permit a more

focused inquiry. 4. Sampling in qualitative studies often occurs in a(n) ____ manner, with decisions

about whom to sample affected by what has already been learned. 5. In ethnographies, key informants are sometimes called cultural 6. Another term for convenience sample is ___ _ unteer sample. 8. case sampling is an approach in which the most unusual or extreme cases

are selected. 9, The principle used by qualitative researchers to decide when to stop sampling.

10. Qualitative researchers are encouraged to use thick.4t..f1.-4_ “ to-enhance the

ability of other people to assess congruence of contexts.

14. In phenomenologic research, a participant must have experienced the phenomenon

of interest in order to be for the study.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

144 PART 4 ® Designing and Conducting Qualitative Studies to Generate Evidence

16. Sampling of politically cases is sometimes used to select or deselect

cases for a study. rs 2.0.0) ae case sampling involves selecting cases to highlight what is usual or

normal.

= B. Study Questions

1. For each of the research questions below, indicate what type of qualitative sam- pling approach you would recommend, being as specific as you can about sampling

approach and sample size.

a. What is the process of adaptation and coping among the partners of AIDS

patients? . What is the lived experience of having a child who is diagnosed with leukemia? . What rituals relating to dying are undertaken by nursing home residents and staff? . What is the experience of waiting for service in a hospital emergency department? . What is the process by which men and women come to terms with an unexpected

diagnosis of pancreatic cancer?

@) {24 ~) ler

2. Suppose a qualitative researcher wanted to study the life quality of cancer survivors. Suggest what the researcher might do to obtain a maximum variation sample; a

typical case sample; a homogeneous sample; and an extreme case sample.

3. Read one of the following open-access articles and identify specific examples of what could be called thick description:

e *McCaughan, D., Sheard, L., Cullum, N., Dunville, J., & Chetter, I. (2018).

Patients’ perceptions and experiences of living with a surgical wound healing by secondary intention. International Journal of Nursing Studies, 77, 29-38.

e *Woodgate, R., Zurba, M., Tennent, P., Cochrane, C., Payne, M., & Mignone, J.

(2017). A qualitative study on the intersectional social determinants for indigenous people who become infected with HIV in their youth. International Journal of Equity in Health, 16, 132.

4. Read the introduction and methods section of one of the following open-access qualitative reports. Use the guidelines in Box 23.1 of the textbook (available as a Word document in the Toolkit @) to critically appraise the sampling plan:

¢ *Dietrich Leurer, M., Petrucka, P., & Msafiri, M. (2019). Maternal perceptions of breastfeeding and infant nutrition among a select group of Maasai women. BMC Pregnancy and Childbirth, 19, 8.

¢ *Dykeman, C., Markle-Reid, M., Boratto, L., Bowes, C., Gagne, H., McGugan, J., & Orr-Shaw, S. (2018). Community service provider perceptions of imple- menting older adult fall prevention in Ontario, Canada. BMC Geriatrics, 18, 34.

“A link to this open-access journal article is provided in the Toolkit €.

CHAPTER 23. & Sampling in Qualitative Research 145

e “Lang, H., France, E., Williams, B., Humphris, G., & Wells, M. (2018). The exis- tence and importance of patients’ mental images of their head and neck cancer: A qualitative study. PLoS One, 13, e0209215.

¢ *Valcarenghi, R., Alvarez, A., Siewert, J., Nunes, S., & Tomasi, A. (2018). The daily lives of people with Parkinson’s disease. Revista Brasileira de Enfermagem, Tal eos

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX B

Read the Method section of the article by Cricco-Lizza (“Infant feeding beliefs”) in Appendix B. Then answer the following questions:

Questions of Fact

What were the eligibility criteria for this study? . How were study participants recruited? . What type of sampling approach was used? How many participants comprised the sample? Was data saturation achieved? Were sample characteristics described? If yes, what were those characteristics? Sai elise MONS Ae

Questions for Discussion

a. Comment on the adequacy of the researcher’s sampling plan and recruitment strategy for achieving the goals of the study.

b. Do you think Cricco-Lizza’s sample size was adequate? Why or why not? c. To what degree was “thick description” provided in the report? Identify examples of

thick description. d. To what types of settings might the findings of this study be transferable?

EXERCISE 2: STUDY IN APPENDIX G

Read the Method section of the article by Byrne and colleagues (“Care transition experi-

ences”) in Appendix G. Then answer the following questions:

Questions of Fact

a. What were the eligibility criteria for this study? b. How were study participants recruited? c. What type of sampling approach was used?

“A link to this open-access journal article is provided in the Toolkit @.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

146 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

d. How many study participants comprised the sample? e. Was data saturation achieved? f. Did the sampling strategy include confirming and disconfirming cases? g. Were sample characteristics described? If yes, what were those characteristics?

Questions for Discussion

a. Comment on the adequacy of the researchers’ sampling plan and recruitment strategy for achieving the goals of a grounded theory study.

b. Assume that you had no resource constraints to address the research questions in this

study. What sampling plan would you recommend? c. Do you think the sample size in this study was adequate? Why or why not? d. Comment on issues relating to the transferability of findings from this study.

= D. The Toolkit 54)

For Chapter 23, the Toolkit G9 on thePoint’ contains a Word file with the following:

¢ Guidelines for Critically Appraising Qualitative Sampling Designs (Box 23.1 of the textbook)

e Links to useful websites for Chapter 23 e Links to relevant open-access journal articles for Chapter 23

CHAPTER 24

Data Collection in Qualitative

Research

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in

Chapter 24. (Puzzles may be removed for easier viewing.)

1 2 3

= \o

a oo ; Eo

= a

nr nr nN ae)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

148 PART4 #® Designing and Conducting Qualitative Studies to Generate Evidence

ACROSS ; 1. The type of interview in which the interviewer uses a list of open-ended questions

that must be covered. 6. Participants can be asked to maintain a journal or that provides rich,

ongoing data about aspects of ordinary life. 7. Unstructured observational data are maintained in notes. 8. The type of observation often undertaken in qualitative studies to “get inside” a

social situation is observation. 13. Interviewers sometimes rely on a(n) guide that specifies the question areas

that must be covered. 14. Methodologic document observers’ thoughts about their data collec-

tion strategies while in the field. 15. A chronology of daily events during field observations is maintained in 16. histories are used to gather personal recollections of events and their per-

ceived causes or consequences and are often used in historical research. 18. The think method involves having people talk about decisions as they are

making them. 19. The ____ rnet can yield rich qualitative data, e.g., through postings in chatrooms

or blogs. 21. Grounded theory researchers write analytic to document ideas about how

the grounded theory is developing.

22. An unstructured interview often begins with a(n) tour question.

23. Observational notes include descriptive and _ _ _ lective notes.

DOWN

2. A(n) is a person who leads a focus group session. 3. Unstructured interviews cons___ _ _ the speech of neither the interviewers nor the

participants.

4. Photo is a technique that uses photographs to encourage participant narratives.

5. Stimulated recall interviews use recordings of social interactions as the basis for discussion.

8. Observers have to make decisions about themselves in the observational setting so as to best capture the behaviors and events of interest.

9, The technique called incidents focuses on the circumstances surrounding particularly notable incidents.

10. The best method to record unstructured interviews is to record them. 11. Researchers who record their in-depth interviews must then them so

that the data can be read, re-read, and analyzed. a2 plnva lite interview, participants are encouraged to provide a chronologic

narration of life experiences.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 24 & Data Collection in Qualitative Research 149

17. Both semistructured and focus group interviews typically involve use of a topic

20. Participant observers may often have to excuse themselves from a setting to briefly down notes about what is transpiring.

= B. Study Questions

. Suppose you were interested in studying the frustrations of patients awaiting labora-

tory test results before a decision on postsurgical treatment for breast cancer can be made. Develop a topic guide for a focused interview on this topic.

. Below are several research problems. Indicate which type of unstructured approach you might recommend using for each. Defend your response.

a. By what process do older brothers and sisters of a handicapped child adapt to their sibling’s disability?

b. What is it like to have a persistent wound? c. What stresses do the spouse of a terminally ill patient experience? d. What type of information does a nurse draw on most heavily in formulating

nursing diagnoses? e. What are the coping mechanisms and perceived barriers to coping among

severely disfigured burn patients?

. Develop a topic guide that focuses on nursing students’ reasons for selecting nursing as a career and their satisfactions and dissatisfactions with their decision. Administer the topic guide to five first-year nursing students in a face-to-face interview situation. Now administer the topic guide in a focus group setting with five nursing students. Compare the kinds of information that the two approaches yielded. What, if any- thing, did you learn in the group setting that did not emerge in the personal inter-

views (and vice versa)?

. Would a psychiatric nurse researcher be well suited to undertake a participant observation study of the interactions between psychiatric nurses and their clients?

Why or why not?

. Read one of the following open access articles (a link is provided in the Toolkit 3), and indicate how, if at all, you would augment the self-report data collected in this study. with participant observation:

e Boulton, E., Horne, M., Todd, C. (2018). Multiple influences on participating in

physical activity in older age. Health Expectations, 21, 239-248.

e Ross, C., Jakubec, S., Berry, N., & Smye, V. (2018). “A two glass of wine shift”:

Dominant discourses and the social organization of nurses’ substance use. Global

Oualitative Nursing Research, S.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

150 PART4 © Designing and Conducting Qualitative Studies to Generate Evidence

6. Read the introduction and methods section of one of the following open access

articles (a link is provided in the Toolkit @). Use the guidelirres in Box 24.3 of the

textbook (available as a Word document in the Toolkit 9) to critically appraise the

data collection aspects of the study:

¢ Chambers, S., Hyde, M., Laurie, K., Legg, M., Frydenberg, M., Davis, [., ...

Dunn, J. (2018). Experiences of Australian men diagnosed with advanced pros-

tate cancer: A qualitative study. BMJ Open, 8, e019917.

° Lee, S., & Lee, E. (2018). Cancer screening in Koreans: A focus group approach.

BMC Public Health, 18, 254. e¢ McGuiness, D., Murphy, K., Bainbridge, E., Brosnan, L., Keys, M., Felzmann,

H., ... Higgins, A. (2018). Individuals’ experiences of involuntary admissions and

preserving control. BJ Psych Open, 4, 501-509. ¢ Unver, S., Eyi, S., & Ozkan, 'Z. (2018). A descriptive, qualitative study to explore

the pain experience during negative pressure wound therapy for postsurgical abdominal wounds. Ostomy Wound Management, 64, 3.

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX B

Read the Method section of the article by Cricco-Lizza (“Rooting for the breast”) in Appendix B—paying special attention to the subsection labeled “Data Collection.” Then answer the following questions:

Questions of Fact

a. Did the researcher collect any self-report data? If yes, what concepts were captured by self-report?

b. What specific types of qualitative self-report methods were used? . Were examples of questions included in the report? . Does the report provide information about how long interviews took, on average?

. How were the self-report data recorded?

. Did this study collect any data through observation? If yes, what concepts were cap- tured through observation?

. If there were observations, how were observational data recorded?

. Who collected the data in this study?

Questions for Discussion

Comment on the adequacy of the researcher’s description of her data collection methods. Comment on the data collection approaches Cricco-Lizza used. Did she fully capture the concepts of interest in the best possible manner?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 24 8 Data Collection in Qualitative Research 151

If examples of specific questions were included in the report, do they appear appro- priate for collecting the desired information? If they were not included, does the absence of such examples undermine your ability to fully understand the quality of evidence the study yielded? If the report described how long the interviews were, do you feel the interviews were sufficiently long to obtain the desired information? If such information was missing, does its absence undermine your ability to fully understand the quality of evidence the study yielded?

. Comment on the procedures used to collect and record data in this study. Were ade- quate steps taken to ensure the highest possible quality data?

. Comment on the degree of participation in which the researcher engaged.

EXERCISE 2: STUDY IN APPENDIX G

Read the Method section of the article by Byrne and colleagues (“Care transition experi- ences”) in Appendix G. Then answer the following questions:

Questions of Fact

. Did the researchers collect any self-report data? If yes, what concepts were captured by self-report?

. What specific types of qualitative self-report methods were used?

. Were examples of questions included in the report?

. Does the report provide information about how long interviews took, on average?

. How were the self-report data recorded?

. Did the researchers collect any data through observation? If no, could observation have been used? If yes, what concepts were captured through observation?

. How were observations, if any, recorded? Were the observations structured or unstructured? Was the method participant

observation?

Questions for Discussion

. Comment on the adequacy of the researchers’ description of their data collection methods.

. Comment on the data collection approaches Byrne and colleagues used. Did they

fully capture the concepts of interest in the best possible manner? . If examples of specific questions were included in the report, do they appear appro- priate for collecting the desired information? If they were not included, does the absence of such examples undermine your ability to fully understand the quality of

evidence the study yielded? . If the report described how long the interviews were, do you feel the interviews were

sufficiently long to obtain the desired information? If such information was missing, does its absence undermine your ability to fully understand the quality of evidence the study

yielded? . Comment on the procedures used to collect and record data in this study. Were ade-

quate steps taken to ensure the highest possible quality data?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

152 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

= D. The Toolkit &3

For Chapter 24 the Toolkit 9 on thePoint’ contains a Word file with the following:

* Guidelines for Critically Appraising Unstructured Data Collection Methods (Box 24.3 of the textbook)

e Example of a Topic Guide for a Semistructured Interview (two examples)

e Example of an Agenda for a Focus Group Session ¢ Focus Groups Versus In-Depth Personal Interviews: Guide to Selecting a Method

e Example of a Protocol for a Windshield (community mapping) Survey ¢ Examples of Types of Information Relevant in Unstructured Observation (from

textbook)

e Example of an Observation Protocol for Unstructured Observation e Links to useful websites for Chapter 24 e Links to relevant open-access journal articles for Chapter 24

CHAPTER 29

Qualitative Data Analysis

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 25. (Puzzles may be removed for easier viewing.)

nN as)

w n

» o

Generating and Assessing Evidence for Nursing Practice (11th ed.)

153

154 PART4 = Designing and Conducting Qualitative Studies to Generate Evidence

ACROSS

2. The nurse researcher who worked with Strauss and helped develop an alternative

approach to grounded theory. 5. Phenomenologic analysis involves the identification of essential 9. In Glaser’s grounded theory method, there are two types of _ _ _ stantive codes:

open and selective. 10. In ethnographies, a(n) is a broad unit of cultural knowledge.

11. In vivo codes are codes in Glaserian open coding. 13. The hermeneutic involves movement between parts and whole of a text

being analyzed. 1S... Gai i was a prominent analyst and writer in the Duquesne school of

phenomenology. 16. In Diekelmann’s approach, the discovery of a constitutive forms the high-

est level of analysis. 18. In Glaserian grounded theory, the developing categories of the substantive theory

must the data. 19. The descriptive phenomenologist

peers or study participants.

i did not espouse validating themes with

22. The hermeneutic approach developed by __ includes an analysis of exemplars. 23. The main form of in phenomenologic analysis is in the form of transcribed

interviews.

26. Timelines and charts are graphic devices that can be used to highlight time sequences in qualitative analysis.

28. The ability to “make meaning” from qualitative texts depends on researchers’ in and closeness to the data.

31. In most qualitative analyses, an early task used to understand and manage the data involves the data.

34. An analysis of a text’s ideas and concepts.

36. A(n) ____ rogram is a tree diagram used to illustrate the arrangement of codes and categories in a hierarchically ordered system.

37. Before analysis begins, qualitative researchers usually develop a coding 38. In content analysis, a meaning u__ _ is the smallest segment of a text that contains

a recognizable piece of information. 39. One of the two major schools of phenomenology (a Dutch school).

t content involves an inductive search for underlying

DOWN

1. In precoding, analysts underline or circle a phrase or in a narrative text that is seen as noteworthy.

3. One type of core variable in Glaserian grounded theory is a social process that evolves over time.

4. A type of coding in Corbin and Strauss’s approach that involves linking subcategories.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 25 Qualitative Data Analysis 155

5. Ana priori coding scheme for deductive coding is sometimes called a(n)

6. When voice recognition software is used, oral transcriptionists still need to__ _ t the text to correct errors.

7. In Glaserian grounded theory, __ _ ective coding focuses on the core category. 8. A device sometimes used as an analytic tool to be evocative, used especially by inter-

pretive phenomenologists.

12. In Glaserian grounded theory, researchers compare concepts emerging from the data with similar concepts from existing theory or prior studies to assess fit with the theory being generated.

14. In grounded theory, the category is a central pattern that is relevant to participants.

17. The second analytic level in Spradley’s ethnographic method is analysis. 18. Glaser originally proposed 18 of theoretical codes to help grounded theorists

conceptualize relationships.

20. The first stage of substantive coding in Glaserian grounded theory involves ____ coding.

21. In Benner’s analytic approach, cases are strong examples of ways of being in the world.

24. Qualitative analysts often document an idea in an analytic 25. In___ _ ework analysis, the fourth step involves charting the data in two-

dimensional matrixes. 26. In manual organization of qualitative data, excerpts are cut up and inserted into a

conceptual

27. In van Manen’s approach, the analyst sees the text as a whole and tries

to capture its meaning.

DOM COGN Ate, © sa t content, coders focus on the actual words of study

participants. 30. Van was a descriptive phenomenologist from the Duquesne school. 32. The purpose of developing a coding scheme is to impose ____ on a mass of

narrative information. 33. The amount of data collected in a typical qualitative study typically is ‘ 35. Descriptive qualitative studies are often described as having involved a(n) _ _ _ tent

analysis of the narrative data.

= B. Study Questions

1. Ask two people to describe what it means to them to have a good health-related quality of life, and record their responses (e.g., using your cell phone). Probe for specific experiences. Transcribe the data, then pool your descriptions with those

of other classmates. Independently develop a coding scheme to organize responses,

and then compare your coding scheme with those of others. Then collaborate in

developing a single coding scheme.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

156 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

2. If possible, listen to a recorded interview completed by an experienced interviewer

and transcribe a few minutes of it. Compare your transcription with that of another

classmate or with that of the professional transcriber.

3. What is wrong with the following statements?

a. Friesen conducted a grounded theory study about coping with a miscarriage in

which she was able to identify four major themes. b. Koretzky’s ethnographic analysis of Haitian clinics involved gleaning related

thematic material from French poetry. c. Allen’s phenomenologic study of the lived experience of Parkinson disease

focused on the domain of fatigue. d. Stewart’s grounded theory study of widowhood yielded a taxonomy of coping

strategies.

e. In her ethnographic study of the culture of a nursing home, O’Connor used a rural nursing home as a paradigm case.

4. Use the scheme presented in Box 1 in this Resource Manual to code the following segments from an actual interview in one of Beck’s studies on birth trauma:

Excerpt Codes

“My pregnancy was planned and initially on discovering | was pregnant

again | was happy and excited to be having a baby and | was able to shut

out thoughts of the fact | would have to give birth again. However, when

| was about 9 weeks pregnant | could no !onger contain this anxiety and |

spiraled into panic attacks thinking that | could not live like that for another

7 months. | went to see my doctor and he prescribed some medication for

my panic attacks. On the whole from 20 weeks on my emotions settled

down and | was focused on the birth and the delivery of my baby. | still had

periods of anxiety normally around when | went for my OB appointments.

When | finally gave birth to my baby | pushed him into the world and | was

shocked. All the scenarios for having another baby that | had run through

in my mind since the traumatic birth of my first child never ended like this. |

had never dreamed for such a perfect delivery. | was there holding my baby

and all that anxiety about his birth had been for nothing. | breastfed my baby

and had a cuddle before giving him to my husband while my episiotomy was

stitched. It was then that it hit me like a brick wall of emotions as my husband

held our baby. He looked just like my daughter had the day she was born but

| had missed some of her precious first hours being in surgery to have my

4th degree tear repaired and at this moment | just sobbed. It was a mixture of joy that my son was ok and | had achieve what | had dreamt of for his birth

and grief for the birth of my first child that had been so very different and so

difficult for me to get over. After the birth | felt confident and proud of my body and of what | had come through since my first traumatic birth. My second birth was very positive and did heal me in some ways. But experiencing what child-

birth should be like made me realize how hideous my first birth was and my second birth can never erase the past memories of my first traumatic birth.”

Note: A coded excerpt from this same study is included in the accompanying Toolkit ©.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 25 Qualitative Data Analysis 157

Box 1 Beck and Watson's (2010) Coding Scheme for Study on a Subsequent Childbirth After a Previous Traumatic Birth

Theme 1: Riding the Turbulent Wave of Panic during Pregnancy

Reactions to learning of pregnancy

Denial during the first trimester

Heightened state of anxiety

Panic attacks as delivery date gets closer

Feeling numb toward the baby moO >

Theme 2: Strategizing: Attempts to Reclaim Their Body and Complete the

Journey to Motherhood

A. Spending time nurturing self by exercising, going to yoga classes, and swimming

Keeping a journal throughout pregnancy

Turning to doulas for support during labor

. Reading avidly to understand the birth process

Engaging in birth art exercises

Opening up to healthcare providers about their previous birth trauma

. Sharing with partners about their fears

. Learned relaxation techniques cH Th Oo Ow

Theme 3: Bringing Reverence to the Birthing Process and Empowering

Women

Treated with respect

Pain relief taken seriously

Communicated with labor and delivery staff

Reclaimed their body

Strong sense of control Birth plan was honored by labor and delivery staff

. Mourned what they missed out with prior birth

Healing subsequent birth but it can never change the past CO™M™MOODD

Theme 4: Still Elusive: The Longed-for Healing Birth Experience

A. Failed again as a woman

B. Better than first traumatic birth but not healing

C. Hopes of a healing home birth dashed

Generating and Assessing Evidence for Nursing Practice (11th ed.)

158 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

5. Suppose a researcher was studying people with hypertension who were strug-

gling unsuccessfully for months to manage their weight. Answer the following

questions:

a. What might be the research question that a phenomenologist would ask relating

to this situation? And what might the research question be for a grounded theory

researcher?

b. Approximately how many study participants would be interviewed for each type

of study? c. Which do you think would take longer to do—the analysis of data for the phe-

nomenologic or the grounded theory? Why? d. What would the final “product” of the analyses be for the two different studies? e. Which study would have more appeal to you? Why?

6. Using Polit’s coding scheme for a study on hunger and food insecurity (the coding scheme is in the accompanying Toolkit G3), code the following segments from actual interviews:

Excerpts Codes

“| buy on deals. | mean, like, um, a lot of people when they go to the gro-

cery store, they see those manager's specials, they won’t buy those. But

it’s a good thing to buy because legally the meat market cannot sell them if

they're bad meats. | mean, I’ve bought packages of steaks, where I’ve only spent $12 for 6 steaks.”

“The kid’s aunt, her husband had sent and closed down this swell house

for Cisco, which is the restaurant type, ah, they service restaurants. And she

gave me big cans of soup, you know, ah, she gave me this big old box of

fish. Stuff like that. Bags of French fries and stuff, you know, just out of the blue. So the Lord is always making a way.”

“I'm always, every other week—after | lost my job—going up to the food

bank, lying about where I’m living so | can get more food from different

food banks to feed my daughter.”

“| donated plasma, took in cans, uh, we ended up asking my mother-in-

law if she could help us in any way, any way we could get help, we were

asking. We managed, | mean, it wasn’t easy but we managed.”

7. Read the methods and results section of one of the following open-access jour- nal articles. Use the guidelines in Box 25.2 of the textbook (available as a Word document in the Toolkit @) to critically appraise the data analysis aspects of the study:

e Bergdahl, E., Ternestedt, B., Berterd, C., & Andershed, B. (2019). The theory of a co-creative process in advanced palliative home care nursing encounters: A quali- tative deductive approach over time. Nursing Open, 6, 175-188.

CHAPTER 25 #® Qualitative Data Analysis 159

¢ Boulton, E., Horne, M., & Todd, C. (2018). Multiple influences on participating in physical activity in older age: Developing a social ecological approach. Health Expectations, 21, 239-248.

¢ Olsson, K., Naslund, U., Nilsson, J., & Hornsten, A. (2018). Patients’ experi- ences of the transcatheter aortic valve implantation trajectory: A grounded theory study. Nursing Open, 5, 149-157.

¢ Shiyanbola, O., Brown, C., & Ward, E. (2018). “I did not want to take that medicine”: African-Americans’ reasons for diabetes medication nonadherence and perceived solutions for enhancing adherence. Patient Preferences and Adherence, 12, 409-421.

e Sinclair, $., Hack, T., Raffin-Bouchal, $., McClement, S., Stajduhar, K.,

Singh, P., ... Chochinov, H. (2018). What are healthcare providers’ under-

standings and experiences of compassion? The healthcare compassion model: A grounded theory study of healthcare providers in Canada. BMJ Open, 8, eOno70lN

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX E

Read the “Data Analysis” and “Results” sections of the article by Cummings (“Sharing a traumatic event”) in Appendix E. Then answer the following questions:

Questions of Fact

See

Did Cummings audio-record and transcribe the interviews? . Did Cummings organize her data manually or with the assistance of computer soft- ware? If the latter, which software was used?

. Did Cummings do any “counting” in her analysis? Which phenomenologic analytic approach was adopted in this study? Did Cummings prepare any analytic memos or keep a reflective journal? How did Cummings describe her analytic process? How many themes emerged in Cummings analysis? What were they?

. Did Cummings provide supporting evidence for her themes, in the form of excerpts

from the data?

Questions for Discussion

a. Discuss the thoroughness of Cummings’ description of her data analysis efforts. Did the report present adequate information about the steps taken in the

analysis? Was there any evidence of “method slurring”—that is, did Cummings apply any ana- lytic procedures that are inappropriate for a phenomenologic approach?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

160 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

c. Discuss the effectiveness of Cummings’ presentation of results. Does the analysis

seem sensible, thoughtful, and thorough? Was a sufficient amount of evidence pro-

vided to support the findings? Were data presented in a manner that allows you to be

confident about Cummings’ conclusions?

EXERCISE 2: STUDY IN APPENDIX G

Read the “Design and Methods” and “Findings” sections of the report by Byrne and colleagues (“Care transition experiences”) in Appendix G. Then answer the following

questions:

Questions of Fact

a. Did the researchers audio-record and transcribe the interviews? If yes, who did the transcription? Did the report state how many pages of data comprised the data set? Did data collection and data analysis occur concurrently?

Was the coding scheme described? What did the report say about the actual coding process? Was a computer used to organize or analyze the data? If yes, what software was used?

f. Did the researchers describe their data analysis process? Did they indicate whose approach to data analysis was used in this grounded theory study?

g. Was constant comparison used in analyzing the data? h. Did the researchers develop and present a conceptual map or model? i. Did the researchers do any “counting” in their analysis?

Were any metaphors used to highlight key findings? Did the researchers prepare any analytic memos?

What was the basic problem that Byrne and coresearchers identified in their research? What was the basic social process?

Ca One

Questions for Discussion

a. Discuss the effectiveness of the researchers’ presentation of results. Does the analysis seem sensible, thoughtful, and thorough? Did the analysis yield insight into transition experiences?

b. Were data presented in a manner that allows you to be confident about the research- ers’ conclusions? Comment on the inclusion or noninclusion of figures that graphi- cally represent the grounded theory.

c. Comment on the number of verbatim quotes from study participants that were included in this report.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 25 Qualitative Data Analysis 161

= D. The Toolkit 54)

For Chapter 25, the Toolkit 9 on thePoint’ contains a Word file with the following:

* Guidelines for Critically Appraising Qualitative Data Analysis (Box 25.2 of the textbook)

A. Resources for Qualitative Analysis: Examples Related to Coding and Categorization

Examples of excerpts with key words/phrases underlined from Beck and Watson’s phenomenologic study of posttraumatic growth (“precoding”) A priori structural codes for Caiola et al.’s study of the social determinants of health

Example of coding using alpha-numeric codes for Polit’s study of hunger and food insecurity in urban families Example of a coded excerpt from Beck and Watson’s (2010) phenomenologic study of subsequent childbirth after a previous traumatic birth Example of a coded excerpt from Beck’s phenomenologic study on the anniver- sary of birth trauma Example of a codebook from Beck’s study of the benefits of participating in Internet interviews

Examples of analytic memos from a grounded theory study and a phenomeno- logic study Example of a coding hierarchy from Beck’s (2002) grounded theory study on mothering multiples Selected excerpts and subcategories for Huang et al.’s (2017) study of reproduc- tive decision-making for reproductive-age women with cancer

. Resources for Qualitative Analysis: Examples: Models of Analytic Processes

Colaizzi’s procedural steps in descriptive phenomenologic analysis Schematic model depicting coding process in Glaserian grounded theory

Schematic model depicting the analytic process for a Reflective Lifeworld Research (RLR) Project (Sidenius et al., 2017)

C. Resources for Qualitative Analysis: Diagrams and Models from Qualitative

Studies by Nurse Researchers

Example of a timeline from Beck’s (2002) mothering multiples study Earthquake model from Beck and Watson’s (2016) phenomenologic study of

posttraumatic growth after birth trauma Model of the fertility decision-making process among reproductive-age women

with cancer (Huang et al., 2017)

Grounded theory of protecting (Furlong, 2017) Model linking themes in Beck’s (2009) phenomenologic study of mothers’ experi- ences caring for children with obstetric brachial plexus injuries

Generating and Assessing Evidence for Nursing Practice (11th ed.)

162 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

e D. Resources for Qualitative Analysis: Steps in the analytic process for various approaches ~

¢ Stages of analysis in the Qualitative Analysis Guide of Leuven (QUAGOL) ¢ Phases of a thematic analysis ¢ The process of qualitative content analysis

¢ Links to useful websites for Chapter 25 e Links to relevant open-access journal articles for Chapter 25

CHAPTER 20

Trustworthiness and Rigor in

Qualitative Research

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 26. (Puzzles may be removed for easier viewing.)

: |

, peeled

2m | | Be

ee ie

Generating and Assessing Evidence for Nursing Practice (11th ed.)

SS Bo | y

164 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

ACROSS ‘ 1. Confirmability can be addressed through a scrutiny of documents and procedures in

an inquiry ,

3. A key criterion for assessing rigor in qualitative studies is 6. The use of multiple means of converging on the truth is called >: Lae SP ea ability refers to the stability of data over time and conditions, Jaki eats

to reliability in quantitative research. 11. Transparency about the investigator’s credentials and experiences gives readers an

opportunity to assess __ _ earcher credibility. 12. There is a(n) of consensus about which term to use to denote the qual-

ity goal in qualitative studies. 15. The extent to which qualitative findings can be applied to other settings is referred

to as 19. Auditability can be enhanced by maintaining a log of each that a

researcher makes, i.e., by documenting judgments and choices. Die description is important in appraising whether findings from a quali-

tative study can be used in other contexts and settings. 22. Collecting data in multiple sites is an example of triangulation. 24. Collecting data through interviews and observations is an example of

‘ triangulation. 25. Credibility in qualitative inquiry has been described as analogous to

validity in quantitative inquiry.

27. A quality-enhancement strategy called __§ t observation is aimed at

achieving adequate depth of the data.

28. A(n) audit involves a scrutiny of data and supporting documents by an external reviewer.

29: Avstrategy calleday—— a nged engagement involves the investment of sufficient

time during data collection to understand the phenomenon under study.

DOWN

2. An audit is a systematic collection of materials for a potential indepen- dent auditor.

4. A music player (brand name—unrelated to research!).

Sh triangulation involves collecting data about a phenomenon at multiple points.

6. In triangulation, researchers use competing hypotheses or conceptual- izations in their analysis and interpretation of data.

7. A procedure referred to as qu _ _ _ statistics is sometimes used as an “accounting” system to assess the validity of certain types of conclusions.

8. A(n) case analysis is a process by which researchers revise their interpreta- tions by including cases that appear to disconfirm earlier hypotheses.

10. Credibility can be enhanced through a thorough search for_______ _ _ _ing evidence.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

13.

14.

. Some believe that quality criteria should be

CHAPTER 26 ‘Trustworthiness and Rigor in Qualitative Research 165

One method of addressing credibility involves going back to participants to do member : Some call the overall goal for the integrity of qualitative research Whittemore and colleagues).

Steyn | fic to research traditions, others

have proposed generic criteria for qualitative inquiries. . Qualitative researchers take steps to enhance the likelihood that, overall, their find- ings are rigorous and :

Stussy yetaroce or triangulation is achieved by having 2+ researchers make key analytic decisions and interpretations.

. Interviewing patients and family members about a phenomenon is an example of source triangulation.

. Lincoln and proposed five criteria for evaluating the quality of qualitative inquiries.

. Researchers typically “ ” transcribed data by comparing transcriptions to recordings and making necessary corrections.

debriefings are sessions with experts other than the researchers to explore alternative ways of interpreting the data.

B. Study Questions

. Suppose you were conducting an in-depth study of couples’ coming to terms with infertility. What strategies might you use to incorporate various types of triangula-

tion into your study?

. In the previous chapter, one study question involved a class exercise to elicit descrip-

tions of people’s conceptions of health-related quality of life (Study question B.1 in Chapter 25). Describe strategies you could use to enhance the integrity of this

inquiry.

. What is your opinion about the value of member checking as a strategy to enhance credibility? Defend your position.

. Read a research report in a recent issue of the journal Qualitative Health Research. Identify several examples of “thick description.” Also, identify areas of the report in which you feel additional thick description would have enhanced evidence quality.

. Read one of the following open-access journal articles (links are provided in the Toolkit G3). Use the critical appraisal guidelines in Box 26.1 of the textbook (avail-

able as a Word document in the Toolkit 9) to evaluate the integrity and quality of

the study—augmented, as appropriate, by questions in Table A of the Supplement

on the book’s website, as well as in the Toolkit @.

emotional support to promote linkage and engagement in HIV care. Patient

Preference and Adherence, 12, 45-52.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

166 PART4 ® Designing and Conducting Qualitative Studies to Generate Evidence

¢ Hussain, L., Kanji, Z., Lalani, $., Moledina, S., & Sattar, A. (2019). Exploring

lived experiences of married Pakistani women post-mastectomy. Asia-Pacific

Journal of Oncology Nursing, 6, 78-85. e McCaughan, D., Sheard, L., Cullum, N., Dumville, J., & Chetter, I. (2018).

Patients’ perceptions and experiences of living with a surgical wound healing by secondary intention. International Journal of Nursing Studies, 77,

29-38. ¢ Olsson, K., Naslund, U., Nilsson, J., & Hornsten, A. (2018). Patients experiences

of the transcatheter aortic valve implantation trajectory: A grounded theory study. Nursing Open, 5, 149-157.

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX E

Read the report by Cummings (“Sharing a traumatic event”) in Appendix E. Then

answer the following questions:

th Questions of Fact

a. Did the researcher devote a section of the report to describing quality-enhancement

strategies? If so, what was it labeled? If not, where was information about such strategies located?

b. What types of triangulation, if any, were used in this study? c. Were any of the following strategies used to enhance the rigor/trustworthiness of the

study?

e Prolonged engagement and/or persistent observation e Peer review and debriefing ¢ Member checks ¢ Search for disconfirming evidence ¢ Reflexivity ¢ Audit trail e Researcher credibility

Questions for Discussion

a. Discuss the thoroughness with which Cummings described her efforts to enhance and evaluate the quality and integrity of her study.

b. How would you characterize the integrity and trustworthiness of this study, based on the researchers’ documentation? How would you describe the credibility, dependabil- ity, confirmability, authenticity, and transferability of this study?

c. Do you think that the researchers’ maintenance of “an extensive audit trail” contrib- uted to the integrity and trustworthiness of this study? Why or why not?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 26 ® Trustworthiness and Rigor in Qualitative Research 167

EXERCISE 2: STUDY IN APPENDIX G

Read the report by Byrne and colleagues (“Care transition experiences”) in Appendix G. Then answer the following questions:

Questions of Fact

a. Did the researchers devote a section of their report to describing their quality- enhancement strategies? If so, what was it labeled? If not, where was information about such strategies located?

. What types of triangulation, if any, were used in this study?

. Were any of the following strategies used to enhance the rigor/trustworthiness of the study?

Prolonged engagement and/or persistent observation Member checks Search for disconfirming evidence

e Reflexivity

¢ Audit trail

Questions for Discussion

Discuss the thoroughness with which Byrne and colleagues described their efforts to enhance and evaluate the quality and integrity of her study. How would you characterize the integrity and trustworthiness of this study, based on the researchers’ documentation? How would you describe the credibility, dependabil- ity, confirmability, authenticity, and transferability of this study?

D. The Toolkit 3

For Chapter 26, the Toolkit G9 on the accompanying CD-ROM contains a Word file

with the following:

Guidelines for Appraising Quality and Integrity in Qualitative Studies (Box 26.1 of

the textbook) Quality Enhancement Strategies in Relation to Lincoln and Guba’s Criteria for

Trustworthiness Questions for Self-Scrutiny during a Study: Whittemore et al.’s Primary Qualitative

Validity Criteria Questions for Self-Scrutiny during a Study: Whittemore et al.’s Secondary

Qualitative Validity Criteria Questions for Post Hoc Assessments of a Study: Whittemore et al.’s Primary

Qualitative Validity Criteria

Questions for Post Hoc Assessments of a Study: Whittemore et al.’s Secondary

Qualitative Validity Criteria Links to useful websites for Chapter 26

Links to relevant open-access journal articles for Chapter 26

Generating and Assessing Evidence for Nursing Practice (11th ed.)

. ©. Application Redbndeta mein ette eit Saran bani ae

ERERESSE 1: STHIPY I APPENDERE Regal tg utr ber sartrecryi vices (“Oe tp 9 (Secemegid ner Acie

i] sa ,_ an en aa ive Ve av - >

lay ann esugnallos ri siya fisidve Peete

pe hte nid hes acorn checeneamnrcn besa patter

EAI pre of erinnnleicn ‘@ Map, Were nied! Dieghte extaaly | > ‘ae fy Mete Pawn satin @ eviha TE LE iy “f atw Hive

ily? +

. i te wailiuye’ ret tanita Wephgaiat be yileuy) PaRLERGTA, 161 2oni

Ounstions kaa... oad

n= ices Fillinee2 ome shat wap eval) ul SR sel apa

TROT ashonaneshovinailagtia) Tog Ione manera: it

ee _ a §

vc sigmer, Dis Yeon to Calon N, a tf f bi ‘cain Prictys our A bch and pep ieee aa Ug (ea Reber i

Dy wie lee Pagiemriiin, epee ty until 4¢ nd rent ae | iy in

Tslloop ved gridioeeh ot sveqe tind? to odiies # ostvals wroly J enCREENONY Atarned)! jon Th She] a alli iennndhag haiRasioneteneenelae : Gen paohenit-acete ah o cop oneneet mpetthangel gotcha daeretgucdi, -— an!) Mewes» Oprivbuiiinntt bey sew ton ii Soisnlnganna te: aay: — co

mt tdi Sealdnce urn\iogn oft syeiles of bot aided = adi te = he

Se ee TY > 7 iia

vermis pido nei wh don °

vbone yl Yo singstni bs

) Wysiliditegraals qodieaiabs uidy bug wae 1. Seam f Sybase aids tn aillid oii fern, vilolinsrtue 3 pear utr

: oat eit em e Dy Bu ¢fic geen ae j= wero ea atiaw . im a3 _ ss aikieew. iasinild ATAMSHATS seovengmas ap Sl) no @2looT oii, bo 19 a 1) 105% 4 a 4 Mestm: . heck:

i geioweitol ah

(sbi aN, (3 doodizsi fa

thaw ve ‘dln baw al oad id woitdled ti acigaund Insmeanedetl pila Lb eeonidsrowirenT

cialiae . 2 1s ™ ell sebtise 8 macirily yniiinoe-tie os sdoneati ae sai) wiibiley a

Aan ‘Ala eau ms re

ie an. . rie re ite eh" a sites ry contra . i.20crrne ep, ae ee

De 4 +0) Cie © « =a

acter) 1 on OS it aaa :

hovonaneccreepeneaiaagallae dO - msl Asie ore 1. - duit épenktneat senna oy

—

Designing and Conducting Mixed NMiethods Studies to Generate Evidence for Nursing

CHAPTER 27

Basics of Mixed Methods

Research

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 27. (Puzzles may be removed for easier viewing.)

nN ess t St is) Sen Ss

ey ao

w = w nr 4 |

as ; a

CHAPTER 27. & Basics of Mixed Methods Research 171

ACROSS

1. A good way to presents MM results is in a(n) display. 3. Ina parallel sample, participants are selected from the same pop_____ _ _ 8. Structured and unstructured are analyzed in mixed methods enidics 9. The paradigmatic basis of mixed methods research is sometimes said to be

11. In an explanatory or exploratory design, there is a time between phases of the study.

TS alntercncemenira a s¢-2 erability is the degree to which mixed methods conclusions can be applied in other contexts.

14. In mixed methods studies, researchers sometimes transform or one type of data into a different type (e.g., qualitizing).

17. Researchers give equal to the QUAL and QUAN strands in some mixed methods studies.

18. In MM studies, researchers may elect to use a(n) design or may make

design decisions based on what they learn initially. 23. In some designs, a key objective is to and contrast the results from the

two strands.

. Mixed methods research is often used to develop and psychometrically assess a(n)

aes sample involves different people in the different strands of the study.

. Mixed methods designs that have two or more distinct phases are designs.

. In mixed method notation, the symbol used when one strand is completed prior to starting the other strand.

. One type of display for MM research is called a(n) statistics-by- display.

. A major determinant of a MM research design is the researcher’s overall in_ _ _ _

. A type of analytic strategy called iterative analysis involves ongoing interpretive

feedback

DOWN

phe

Mixed methods research can only achieve its full potential for enhanced insights when of the two strands occurs. The strand that has the dominant status is often symbolized in case

letters. . In the for a convergence design (QUAN + QUAL), the results for

the two strands are merged and then compared and contrasted.

. Mixed methods designs are often portrayed using a(n) system developed

by nurse researcher Janice Morse.

. When one strand has higher priority than another strand in mixed methods

research, it is said to have status.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

172 PART5 ® Designing and Conducting Mixed Methods Studies to Generate Evidence

7. Mixed methods are sometimes used asa__ _ _ _ rmatory strategy, using multiple

methods to converge on the truth. = 10. In designs, data for the two strands are collected simultaneously.

12. One tool to support mixed methods analyses is a meta- 15. One of many sources of data in mixed methods studies could be Aetee from

unstructured observations. 16. A core MM design with the notation QUAN + QUAL is called a(n)

design. (eine symbol is used to designate simultaneous collection of the two strands

of data. Me sampling occurs when the same participants are in both strands of a

mixed methods study. 20. A widely used software for MM studies is called Miner. 21. Sometimes an MM researcher uses a fixed design, such as one of the three core

designs, but sometimes the design is__ = nt. 22. An acronym for mixed methods research. 25ein sampling, participants in the qualitative strand are a subset of the

participants in the quantitative strand. 26. Creswell and Clark are two prominent mixed methods scholars. 27. The strand that does not have the dominant status is often symbolized in

C: case letters. “ 28. A(n) inference is a conclusion generated by integrating inferences from both

strands of a mixed methods study. 30. A QUAL + quan design does not have a specific in the Creswell and

Plano Clark design typology.

= B. Study Questions

1. Read one of the following open-access articles (a link is provided in the Toolkit @}). in which quantitative data were gathered and analyzed to address a research question. What was the primary research question in this study? Write one or two related research questions that could be addressed with qualitative data to strengthen the study’s inference quality or enhance its interpretability:

¢ Corben, P., & Leask, J. (2018). Vaccination hesitancy in the antenatal period: A

cross-sectional survey. BMC Public Health, 18, 566.

lee, C.; Ho; J*, Fong: Ds Mactarlane, D..@ecin, E., Lee, iA‘, ...i\Chenp kan2008).

Dietary and physical activity interventions for colorectal cancer survivors: A ran- domized controlled trial. Scientific Reports, 8, 5731.

° Struct, H., Besen, D., Duman, M., & Yeter Erbil, E. (2018). Coping with stress among pregnant women with gestational diabetes mellitus. Journal of Caring Science, 7, 9-15.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 27. & Basics of Mixed Methods Research 173

2. How would you design a mixed methods study to address the combined questions from Exercise B.1? Draw a visual diagram of the design that you think would be especially well suited and indicate the appropriate MM notation.

3. Read one of the following open-access articles (a link is provided in the Toolkit 3), in which qualitative data were gathered and analyzed to address a research question. What was the primary research question in this study? Write one or two related research questions that could be addressed with quantitative data to strengthen the study’s inference quality:

¢ Bonsu, A., & Ncama, B. (2019). Recognizing and appraising symptoms of breast cancer as a reason for delayed presentation in Ghanaian women: A qualitative study. PLoS One, 14, e0208773.

¢ Kupper, F., Peters, L., Stuijfzand, S., den Besten, H., & van Kesteren, M.

(2018). Usefulness of image theater workshops for exploring dilemmas in diabetes self-management among adolescents. Global Qualitative Nursing Research, 5, 1-10.

¢ Mills, J., Wand, T., & Fraser, J. (2018). Exploring the meaning and practice of self-care among palliative care nurses and doctors: A qualitative study. BMC Palliative Care, 17, 63.

e Paradiso, C., & Lally, R. (2018). Nurse practitioner knowledge, attitudes, and

beliefs when caring for transgender people. Transgender Health, 3, 47-56.

4. How would you design a mixed methods study to address the combined questions from Exercise B.3? Draw a visual diagram of the design that you think would be especially well suited and indicate the appropriate MM notation.

5. Below is a brief description of a mixed methods study, followed by a commentary. Do you agree with these comments? Can you add other comments regarding the

study design? For example, what were the researcher’s design and sampling strate- gies? What type of joint display could the researcher have used to present the mixed

methods findings?

Fictitious Study. Soukup conducted a study to examine the emotional well-being of

women who had a mastectomy. Soukup wanted to develop an in-depth understanding

of the emotional experiences of women as they recovered from their surgery, includ-

ing the process by which they handled their fears, their concerns about their sexual-

ity, their levels of anxiety and depression, their methods of coping, and their social

supports.

Soukup’s basic study design was a descriptive qualitative study. She gathered infor-

mation from a sample of 26 women, primarily by means of in-depth interviews with the

women on two occasions. The first interviews were scheduled within 1 month after the

surgery. Follow-up interviews were conducted about 12 months later. Several women

in the sample participated in a support group, and Soukup attended and made obser-

vations at several meetings. Additionally, Soukup decided to interview the “significant

Generating and Assessing Evidence for Nursing Practice (11th ed.)

174 PART5 Designing and Conducting Mixed Methods Studies to Generate Evidence

other” (usually the women’s husbands) of most of the women, when it became clear

that the women’s emotional well-being was linked to the manner in which the signifi-

cant other was reacting to the surgery.

In addition to the rich, in-depth information she gathered, Soukup wanted to be able

to better interpret the emotional status of the women. Therefore, at both the origi-

nal and follow-up interview with the women, she administered a psychological scale

known as the Center for Epidemiological Studies Depression Scale (CES-D), a quanti-

tative measure that has scores that can range from 0 to 60. This scale has been widely

used in community populations and has cut-off scores designating when a person is at

risk of clinical depression (a score of 16 and above).

Soukup’s qualitative analysis showed that the basic process underlying psychologi-

cal recovery from the mastectomy was something she labeled “Gaining by Losing,” a

process that involved heightened self-awareness and self-respect after an initial period

of despair and self-pity. The process also involved, for some, a strengthening of per-

sonal relationships with significant others, whereas for others, it resulted in the birth of

awareness of fundamental deficiencies in their relationships. The quantitative findings

confirmed that a very high percentage of women were at risk of being depressed at

1 month after the mastectomy, but at 12 months, the average level of depression was

actually modestly lower than in the general population of women.

Critical Appraisal. In her study, Soukup embedded a quantitative measure into her field

work in an interesting manner. The bulk of data were qualitative —in-depth interviews

and in-depth observations. However, she also opted to include a well-known measure

of depression, which provided her with an important context for interpreting her data.

A major advantage of using the CES-D is that this scale has known characteristics in

the general population, and therefore it offered a built-in “comparison group.”

Soukup used a flexible design that allowed her to use her initial data to guide her

inquiry. For example, she decided to conduct in-depth interviews with significant oth-

ers when she learned their importance to the women’s process of emotional recovery.

Soukup did do some advance planning, however, that provided loose guidance. For

example, although her questioning undoubtedly evolved while in the field, she had the

foresight to realize that to capture a process as it evolved, she would need to collect

data longitudinally. She also made the up-front decision to use the CES-D to supple-

ment the in-depth interviews.

In this study, the findings from the qualitative and quantitative portions of the study

were complementary. Both portions of the study confirmed that the women initially

had emotional “losses,” but eventually they recovered and “gained” in terms of their

emotional well-being and their self-awareness. This example illustrates how the valid-

ity of study findings can be enhanced by the blending of qualitative and quantitative data. If the qualitative data alone had been gathered, Soukup might not have gotten a good handle on the degree to which the women had actually “recovered” (vis a vis women who had never had a mastectomy). Conversely, if she had collected only the CES-D data, she would have had no insights into the process by which the recovery occurred.

CHAPTER 27. & Basics of Mixed Methods Research 175

6. Read one of the following mixed methods studies. Use the guidelines in Box 27.1 of the textbook (available as a Word document in the Toolkit @) to critically appraise the study:

e *Aluko, J., Anthea, R., & Marie-Modeste, R. (2019). Manpower capacity and reasons for staff shortage in primary health care maternity centers in Nigeria: A mixed-methods study. BMC Health Services Research, 19, 10.

¢ *Bluethmann, S., Murphy, C., Tiro, J., Mollica, M., Vernon, S., & Bartholomew,

L. (2017). Deconstructing decisions to initiate, maintain, or discontinue adjuvant

endocrine therapy in breast cancer survivors: A mixed methods study. Oncology Nursing Forum, 44, E101-E110.

¢ *Loft, M., Esbensen, B., Kirk, K., Pedersen, L., Martinsen, B., Iversen, ...

Poulsen, I. (2018). Nursing staff self-perceived outcome from a rehabilitation 24/7 educational programme—a mixed methods study in stroke care. BMC Nursing, 17, 17.

= C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX B

Read the article by Cricco-Lizza (“Infant feeding beliefs”) in Appendix B. Was this a mixed methods study? If yes, describe its design. If no, redesign the study in such a fashion that it would involve mixed methods. In your design, specify the following: (1) the new question(s) that would be addressed; (2) the specific design, using symbols to designate priority and sequence; (3) the sampling design that would be used; and (4)

additional data that would be collected.

EXERCISE 2: STUDY IN APPENDIX F

Read the article by Eckhardt and colleagues (“Fatigue in coronary heart disease”) in Appendix F. Then answer the following questions:

Questions of Fact

a. Was this a mixed methods study? If yes, what was the purpose of the quantitative strand, and what was the purpose of the qualitative strand?

b. Which strand had priority in the study design? Was the design sequential or concurrent?

d. Using the design names used in the textbook, what would the design be called? ©

* A link to this open-access article is provided in the Toolkit 3 for this chapter.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

176 PART5 ® Designing and Conducting Mixed Methods Studies to Generate Evidence

e. How would the design be portrayed using the notation system described in the text-

book? Did the researchers themselves use this notation? ms

f. What sampling design was used in this study?

g. Were any quantitative data qualitized? Were any qualitative data quantitized?

h. What specific step did the researchers use to avoid biasing the coding of the qualita-

tive data? i. What did the report say about how the two strands were integrated?

j. Did the report present a joint display?

Questions for Discussion

a. Evaluate the use of a mixed methods approach in this study. Did the approach yield richer or more useful information than would have been achieved with a single-

strand study? b. Discuss the researchers’ choice of a specific research design and the sampling design.

Would an alternative mixed methods design have been preferable? If so, why? c. How would you characterize the way in which the researchers integrated the two

strands? Do you think the integration maximized the benefits of having used a mixed

methods approach?

= D. The Toolkit eo

For Chapter 27, the Toolkit G3 on thePoint’ contains a Word file with the following:

¢ Guidelines for Critically Appraising Mixed Methods Studies (Box 27.1 of the textbook)

e Examples of Supplementary Questions for Different Types of Study e Mixed Methods Research Integration: Selected Strategies (adapted from Fetters &

Molina-Azorin, 2017)

Mixed Methods Research Questions, by Type of Design (Cresswell & Plano Clark) Example of a Joint Display: Modified Stem Leaf Plot (Happ et al.) Example of a Joint Display: Scatterplot (Happ et al.) Example of a Joint Display (Pedersen et al.)

Example of a Mixed Methods Design, Convergent (Beck et al.) Example of a Dendrogram from a Mixed Methods Study (Beck et al.) Links to useful websites for Chapter 27 Links to relevant open-access journal articles for Chapter 27

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 20

Developing Complex Nursing

Interventions Using Mixed

Methods Research

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 28. (Puzzles may be removed for easier viewing.)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

178 PART5 ™® Designing and Conducting Mixed Methods Studies to Generate Evidence

ACROSS

1. People who have an involvement with an intervention or with the group being

treated are oftenicalledeaaen pase Se rs. 7. It takes a considerable amount of time and____———__ to develop, implement, and

test an intervention. 8. One design decision concerns the intervention ___ —the place where the inter-

vention will be implemented. 11. One of many goals of early development work is to devise strategies to

keep participants enrolled in the intervention and in the study. 12. Some of the of intervention research reflect resistance on the part of

patients, family members, or healthcare staff to change. 15. Before an intervention is created or tested, a lotof_____§_§___ nt work is needed

(Phase I). 17. An ideal intervention addresses a pressing problem and is efficacious, cost-effective,

and (e.g., no side effects). 18. In designing an intervention, consultation with is especially useful if the

existing evidence base is thin. 23. A major in developing complex interventions concerns the fact that

human beings, with their own preferences and viewpoints, are involved. 25. When an intervention is being tested, both proximal and outcomes

must be considered. 26. Patient can often affect how acceptable an intervention is and should

be taken into account in designing the intervention. 27. One of the theories that has been found useful in designing health interventions is

the Health Model. 30. A literature is one of the first steps in planning an intervention project. 32. Social ___ _ itive Theory can serve as the intervention theory for complex

interventions.

33. The focus of the Phase III work is usually on testing the of the intervention.

35. A widely used framework for intervention development and testing was developed in this British organization (acronym).

36. A framework sometimes used for the development and testing of health promotion interventions is called the -PROCEED model.

37. In the MRC model, the last phase might involve efforts to the complex intervention into routine health services.

DOWN

2. The people who deliver the intervention are sometimes called intervention : 3. When it comes to intervention development, researchers must “ ” the prob-

lem the intervention will address.

4. In Phase III research for complex interventions, a qual component is often into the primarily QUAN design.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 28 ® Developing Complex Nursing Interventions Using Mixed Methods 179

. A(n) theory is the basis for predicting how important outcomes can be achieved.

. In Phase III of an intervention project, the mixed methods design is often__ _ _ + qual.

. Health intervention research often involves an interdisciplinary of researchers.

. A(n) phase is almost always needed in intervention research so that refinements to the intervention can be made.

. A key product of Phase II work is usually the documentation of learned.

. A key objective in Phase II is to assess the of the intervention in a real-world setting.

. During Phase I, exploratory and __ research can pave the way for better understanding a problem and the target group.

. A theory that has been found useful in designing health interventions is Theory of Behavior.

. In designing an intervention, a decision needs to be made about the potency and

ete, ty of the treatment.

. Intervention protocols can be subjected to content experts.

ehe al Research Council revised its widely used intervention framework in

ation by a panel of

. Although often portrayed as a four-phase process, intervention development and testing is rarely a process.

. During the process of modeling the intervention, it is useful to develop a visual model that shows how the intervention is expected to “work.”

. It is useful to have a(n) work to guide the myriad tasks of intervention

research. . Interventions can be described along a continuum from __ _ _ le to complex.

. The acronym for a widely used implementation theory that focuses on how new interventions become embedded within social contexts.

B. Study Questions

it . Suppose you wanted to develop an intervention to improve the nutritional status of older adults at risk of frailty. Read the following open-access review (a link is avail-

able in the Toolkit G3).

e Hernandez Morante, J., Gomez Martinez, C., Morillas-Ruiz, J. (2019). Dietary

factors associated with frailty in old adults: A review of nutritional interventions to prevent frailty development. Nutrients, 11, E102.

Then, make a list of the kind of questions you might want to address in further

descriptive research with the patient population or key stakeholders before designing the

int ervention. (Alternatively, read a systematic review on a topic of interest to you and

then proceed to identify key questions.)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

180 PART5 © Designing and Conducting Mixed Methods Studies to Generate Evidence

2. Read one of the following open-access articles (a link is available in the Toolkit @).

Use the relevant appraisal guidelines in Box 28.2 of the textbook (available as a Word document in the Toolkit G3) to critically appraise the study.

e Fasugba, O., Cheng, A., Russo, P., Northcote, M., Rosebrock, H., & Mitchell, B.

(2018). Reducing urinary catheter use: A protocol for.a mixed methods evalua- tion of an electronic reminder system in hospitalised patients in Australia. BMJ

Open, 8, e020469. ¢ Hoben, M., Norton, P., Ginsburg, L., Anderson, R., Cummings, G., Lanhan,

H., ... Estabrooks, C. (2017). Improving Nursing home care through Feedback On perfoRMance data (INFORM): Protocol for a cluster-randomized trial.

Trials; 1 83.9. ¢ Johnston, B., Patterson, A., Bird, L., Wilson, E., Almack, K., Mathews, G., &

Seymour, J. (2018). Impact of the Macmillan specialist Care at Home service. A mixed methods evaluation across six sites. BMC Palliative Care, 17, 36.

e Keys, E., Benzies, K., Kirk, V., & Duffett-Leger, L. (2018). Using play to improve infant sleep: A mixed methods protocol to evaluate the effectiveness of the Play2Sleep intervention. Frontiers in Psychiatry, 9, 109.

. Read the following open-access journal article about an intervention (a link is provided in the Toolkit G3). Where does the intervention fall on a simple-complex continuum? Consider how (or whether) the intervention could be made more com-

plex. Then consider the additional costs of adding complexity, and the potential for enhanced benefits.

¢ Johansson, L., Lindahl, B., Knutsson, S., Ogren, M., Persson Waye, K., &

Ringdal, M. (2018). Evaluation of a sound environment intervention in an ICU: A

feasibility study. Australian Critical Care, 31, 59-70.

a C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX A

Read the article by Nyamathi and colleagues (“Achieving drug and alcohol abstinence”) in Appendix A. Then answer the following questions:

Questions of Fact

a. Could the intervention that was tested in this study be described as a complex inter- vention? If yes, along which dimensions is it complex?

. Was there an intervention theory that guided the development of the intervention?

. Did the authors mention the Medical Research Council framework? Did they men- tion any other intervention development framework?

. Did the researchers complete developmental research that facilitated the development of the intervention?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 28 ™ Developing Complex Nursing Interventions Using Mixed Methods 181

. Did the researchers develop and present a logic model reflecting anticipated pathways of program effects?

. Was the intervention that was tested in this study pilot tested? If not, was this study itself a pilot test?

. Was a mixed methods approach used in the part of the study described in this article?

Questions for Discussion

. Comment on the researchers’ process of developing the intervention. Suppose that the study described here was the pilot test for the intervention. What changes, if any, would you make to the intervention or the study design, based on the study results?

What additional research questions could this study have addressed through the col- lection of qualitative data? What types of qualitative data might you recommend to answer those questions?

EXERCISE 2: STUDY IN APPENDIX D

Read the article by Kim (“Dietary approaches to stop hypertension”) in Appendix D. Then answer the following questions:

Questions of Fact

a. Could the intervention that was tested in this study be described as a complex inter- vention? If yes, along which dimensions is it complex?

b. Was there an intervention theory that guided the development of the intervention? . Did the authors mention the Medical Research Council framework? Did they men-

tion any other intervention development framework? . Did the researchers complete developmental research that facilitated the development of the intervention?

. Was the intervention that was tested in this study pilot tested? If not, was this study itself

a pilot test? . Was a mixed methods approach used in the part of the study described in this

article?

Questions for Discussion

. Comment on the researchers’ process of developing the intervention.

. What changes, if any, would you make to the intervention or the study design, based on the study results?

What additional research questions could this study have addressed through the

collection of qualitative data? What types of qualitative data might might you recom-

mend to answer those questions?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

182 PART5 ® Designing and Conducting Mixed Methods Studies to Generate Evidence

a D. The Toolkit 3

For Chapter 28, the Toolkit G9 on thePoint’ contains a Word file with the following:

¢ Guidelines for Critically Appraising Aspects of Intervention Projects (Box 28.2 of the textbook)

e Dimensions of Intervention Complexity e Broad Steps for Intervention Mapping e¢ The PRECEDE-PROCEED Intervention Framework e Six Steps in Quality Intervention Development (6SQuID) ¢ Medical Research Council’s Original Framework (2000) for Developing and Testing

Complex Healthcare Interventions e Example of a Matrix for Recording Intervention Decisions ¢ Normalization Process Theory (NPT) Core Constructs

e Links to useful websites for Chapter 28 e Links to relevant open-access journal articles for Chapter 28

CHAPTER 29

Feasibility and Pilot Studies

of Interventions Using Mixed Methods

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 29. (Puzzles may be removed for easier viewing.)

N w

— > Nn

— ee

LS ul

Nn i—)

N wo

Generating and Assessing Evidence for Nursing Practice (11th ed.)

184 PART5 ® Designing and Conducting Mixed Methods Studies to Generate Evidence

ACROSS

1. A major goal of pilot work is to assess the of various aspects of

evaluating a new intervention. 4. A product of pilot work is a thorough description of learned. 6. -related objectives often focus on recruitment, retention, and accept-

ability of the intervention. 8. Researchers are better equipped to decide how best to proceed after pilot work if

they articulate specific for their objectives. 12. In pilot work, researchers can evaluate whether the criteria for inclu-

sion in the study are too stringent in terms of ease of recruitment.

15. In pilot work, some have suggested that a 95% ____ around effect size estimates is

too strict. 16. In pilot work, hypothesis _ _*_ _ ing for intervention efficacy should not be a goal. 18. One strategy to learn more about what worked and what did not work in a pilot

study is to conduct interviews with study participants at the end of the trial.

19. The “rule of three” can be applied to estimate upper bounds on outcomes relating to (e.g., adverse events).

20. Objectives relating to the adequacy of various systems (e.g., reporting, monitoring)

can be classitied as __ > 2 ment-related objectives.

23. It is usually advisable, in preparing for a full trial, to use a pilot design that involves

i“ _ assignment to 2+ treatment groups.

DOWN

1. A pilot intervention study provides a “trial run” for a(n) random- ized controlled trial (two words).

2. Experts recommend a sample size of at least per group ina pilot trial, especially if funding for the pilot is desired.

3. When an effect size from a pilot is very large, researchers who use these estimates directly in sample size calculations risk designing a full RCT that is = mea:

5. In pilot work, researchers should clearly articulate specific for the study.

7. Many researchers use information from a pilot study to compute estimates of requirements for a full trial (two words).

9. The focus of this chapter was on work.

10. Researchers use the results of a pilot to either (1) move forward to a full trial, (2) re_______ intervention or study protocols, or (3) abandon the project.

11. If results from a pilot suggest the need for a fairly small sample for a full trial, there is a risk that a(n) error could be committed (two words).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 29. Feasibility and Pilot Studies of Interventions 185

13. When researchers conduct a(n) pilot, results from the early stages of the study are used to revise sample size projections in a large trial.

14. A resource-related objective can involve estimating the monetary of the intervention.

17. A stand-alone pilot study designed to inform the design of a larger trial is sometimes referred asia(n)iO 22 6... al pilot.

21. The statistic d is one of several indicators of (acronym). 22. Pilots benefit from a design that incorporates both qualitative and quanti-

tative data (acronym).

= B. Study Questions

1. Read the following report about a pilot intervention study, and describe how the

pilot findings could be used to refine procedures for a full RCT of the intervention:

e Davis, L., & McCoy, T. (2019). An educational and skill-building intervention to

improve symptom recognition and interpretation in women with acute coronary

syndrome: A pilot study. Dimensions of Critical Care Nursing, 38, 29-37.

2. Read one of the following open-access journal articles on pilot work. (A link to these studies is available in the Toolkit @). What were the key “lessons learned”?

e Griauzde, D., Kullgren, J., Liestenfeltz, B., Ansari, T., Johnson, E., Fedewa, A.,

Saslow, L., ... Heisler, M. (2019). A mobile phone-based program to promote

healthy behaviors among adults with prediabetes who declined participation in free diabetes prevention programs: Mixed-methods pilot randomized controlled trial. JMIR mHealth and uHealth, 7, e11267.

¢ Lelutiu-Weinberger, C., Manu, M., Ionescu, F., Dogaru, B., Kovacs, T.,

Dorobantescu, C., ... Pachankis, J. (2018). An mHealth intervention to improve

young gay and bisexual men’s sexual, behavioral, and mental health in a structur- ally stigmatizing national context. JMIS mHealth and uHealth, 6, e183.

e Kim, S., Darwish, S., Lee, S., Sprague, C., & DeMarco, R. (2018). A randomized

controlled pilot trial of a smoking cessation intervention for US women living with HIV. International Journal of Women’s Health, 10, 545-555.

3. Read the following open-access journal article, which presents a study protocol for a randomized pilot trial (a link to the study is available in the Toolkit 9). Comment on your perceptions of the adequacy of the proposed plan and the proposed study

objectives. What modifications to the protocol would you suggest?

° Carswell, C., Reid, J., Walsh, I., McAneney, H., & Noble, H. (2019).

Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: A feasibility study protocol. Pilots and

Feasibility Studies, 5, 1.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

186 PART5 ® Designing and Conducting Mixed Methods Studies to Generate Evidence

4. Read one of the following open-access journal articles describing pilot studies in

which nurse researchers were involved (a link to these studies is available in the

Toolkit @). Use the relevant appraisal guidelines in Box 29.1 of the textbook (avail- able as a Word document in the Toolkit 3) to critically appraise the study:

¢ Chen, J., Guedes, C., Cooper, B., & Lung, A. (2017). Short-term efficacy of an

innovative mobile phone technology-based intervention for weight management

for overweight and obese adolescents: Pilot study. Interactive Journal of Medical

Research, 6, e12.

e Pyatak, E., Carndang, K., Vigen, C., Blanchard, J., Sequeira, P., Wood, J., ...

Peters, A. (2017). Resilient, Empowered, Active Living with Diabetes (REAL

Diabetes) study: Methodology and baseline characteristics of a randomized con- trolled trial evaluating an occupation-based diabetes management intervention for young adults. Contemporary Clinical Trials, 54, 8-17.

e Santos, M., Conceicao, A., Ferreti-Rebustini, R., Ciol, M., Heithkemper, M., &

Cruz, D. (2018). Non-pharmacological interventions for sleep and quality of life: A randomized pilot study. Revista Latino-Americana de Enfermagem, 26, e3079.

e\ang, C.siduas Y., bu, bl. hele. blame Wa EUs) eal o Ea.

Effects of a mutual recovery intervention on mental health in depressed elderly community-dwelling adults: A pilot study. BMC Public Health, 17, 4.

a C. Application Exercises

EXERCISE: STUDY IN APPENDIX D

Read the article by Kim and colleagues (“Dietary approaches to stop hypertension”) in Appendix D. Then answer the following questions:

Questions of Fact

a. Did the researchers indicate in the title of their report that the study was a pilot or feasibility study? Did the abstract provide this information?

. Did the researchers use the term “pilot study” or “feasibility study”?

. What were the specific objectives of the study? Were any criteria for decision-making about “next steps” articulated?

Did the researchers address any process-type objectives (e.g., recruitment, retention, acceptability)?

Did the researchers assess the potential efficacy of their intervention? Were signif-

icance tests used? Were effect size estimates computed? Did the researchers report confidence intervals around any of their estimates? What research design was used in this research? Did the researchers comment on any limitations of their design? How large was the sample?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

1. iF

CHAPTER 29 #® Feasibility and Pilot Studies of Interventions 187

Was a mixed methods approach used in this study? If yes, what was the nature of any qualitative data that were gathered? Did the researchers reach a conclusion about “next steps” based on this study? Did the researchers suggest any revisions to the intervention protocols?

Questions for Discussion

Comment on the research design used for this study. Why do you think the research- ers opted not to use a randomized design? Comment on the sample size used in this study. Was the sample size sufficient for meeting the goals of the study? The researchers stated that an aim of this article was to “share lessons learned” in developing the intervention. What were the key lessons that they shared?

. Do you think the researchers gleaned enough information in this pilot work to move forward directly to a full-scale trial? Why or why not?

. Search in the literature to see if any member of this research team has reported undertaking a larger-scale study. If so, were any changes made to the intervention protocol?

D. The Toolkit &3

For Chapter 29, the Toolkit G3 on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising Pilot Work (Box 29.1 of the textbook) Example of Pilot Objectives and Criteria for Success—Worksheet (Table 29.3 of the

textbook) Confidence Intervals around Selected Proportions, for Selected Sample Sizes: 95%

CI, 90% CI, and 68% CI. Links to useful websites for Chapter 29 Links to relevant open-access journal articles for Chapter 29

Generating and Assessing Evidence for Nursing Practice (11th ed.)

@ |

«4

rev GID ries al ames

a ——myphanl «dons 22) sien tt te Ha

- be lQ

rd amen pfiViers) salle id thi Pitivis ity ely at Sa ‘nil = ‘ “cy a ; ave oT vate in agi tk - 2 Pratanesen ont dl aie

Lys re se icn? FS:

—

- } ’ ccs i _ :

Pe ee oo ete =. A ats i>.

mo SPSS GF Py oi esiitahi ae ie 0) nish bre esviiagidO si te ame

Diary anpndehss ta shop have ot Lah ade same? bat arta dovrsitl vanebe =~ 88s bat ee ee Uf xaRbd2 sol eatielow Iylsey gi ; of y otqenhed wid gees [RAwO) & eS 9hnG qo igevalay of 3a 7 eure epare tt en yular a -_ peiice this laivenatin? Z : > “ett wads” te fe ibility enudy”? — - > othe tuals¢ Were any Gireria loe vicmeat

— x

— eo ena _— series ic, ren

i, a — ~ eae | chert (ofervents " 1 Se es , heart ct [id ghe

f Mie; oor it (a saepes!.~. Via) “de ag © the <¢geiia® ritations Aen

rik a ‘rte @ ww-ihe cat _

Fem rind © harap eachly epee aS weasel = :

Building an Evidence

Base for Nursing

Practice

CHAPTER 30

Systematic Reviews of Research

Evidence

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 30. (Puzzles may be removed for easier viewing.)

Be W3

SAR : 8 9 se

CHAPTER 30 ® Systematic Reviews of Research Evidence 191

ACROSS

ike

A widely used system to assess confidence in the findings about a specific outcome in a systematic review is called A(n) of findings table is often included in quantitative sys- tematic reviews. A(n) effect size in a metasummary is the ratio of reports with a particu- lar thematic finding, divided by all reports relating to a phenomenon.

10. The type of model used in meta-analysis that takes both within-study and between- study variability into account is called a(n) effects model.

14. One theory-building qualitative integration approach is grounded theory. dGteNietal pine, at | ssion is a method of analyzing the effect of multiple clinical and

method factors on variation in effect size.

17. Study quality can be examined in relation to effect size using either a component or approach.

18. Systematic reviews are sometimes characterized as interpretive or __ _ regative.

21. In a meta-analysis, a(n) analysis involves examining the extent to which effects differ for different types of studies, people, or intervention elements.

24. The numerator for computing a weighted average effect is the of each pri- mary study’s ES times the weight for each study.

25. In a mixed studies review, there must be at least research questions. 26. Analysts must choose a(n) for the meta-analysis that addresses the issue

of heterogeneity. 30. Some writers classify designs for mixed studies reviews as either sequential or __ _

vergent (concurrent).

31. Another name for the effect index d is standardized mean f 35. A concern in a systematic review is the bias that can stem from identify-

ing only studies in journals and books. 36. One way to address primary study quality is to do a(n) __§ __ _ _ ivity analysis that

includes and then excludes studies of low quality. 38. An acronym used for the term used by the Cochrane Collaboration for reviews that

synthesize qualitative findings. 39. A meta-analyst must make decisions about how to address the inevitable

of effects across studies. 40. Systematic reviews integrate findings from multiple prim _ _ _ studies.

DOWN

2. A streamlined approach to evidence synthesis, typically completed within weeks, is

called a(n) review.

A design for a mixed studies review, suggested by Sandelowski et al., called a(n)

design, is a coordinated and sequential series of syntheses.

A systematic review of multiple systematic reviews is often called an um ____ __

review.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

192 PART6 #® Building an Evidence Base for Nursing Practice

6. A(n) plot is a graphic display of the effect size (including CIs) of each pri-

mary study.

8. A preanalysis task in systematic reviews is to information about study

and sample characteristics from each study in the sample.

9. Each primary study in a meta-analysis must yield a quantitative estimate of the

of the independent variable on the outcome. 11. One of the originators of a widely used approach to metasynthesis

(metaethnography). 12. One of several effect size indicators for dichotomous outcomes (acronym).

13. A(n) , which involves calculating manifest effect sizes, can lay the foun-

dation for a metasynthesis. 15. Extraction and quality assessment should be done by more than one reviewer so that

intercoder __ _ _ ability can-be assessed.

19. There is evidence of a bias against the hypothesis in published studies. 20. An early question in a quantitative systematic review is whether it is justifiable to

results across studies statistically. 22. The body of unpublished studies is sometimes referred to as the

literature. 23. Paterson’s approach to metasynthesis is called a meta : 27. In a meta-analysis, researchers may need to primary studies whose reports

are written in certain languages (e.g., those not in English). 28. A(n) review is a preliminary exploration of the literature to map and

clarify the evidence base. 29. A(n) effect size is the ratio of the number of themes represented in

one report, divided by all relevant themes relating to a phenomenon across all reports.

32. In a(n) effects model, it is assumed that one true effect size underlies all

study results.

33: appraisal is undertaken in most systematic reviews, although approaches to using the information vary.

34. In a metaethnography, a critical step involves a(n) of argument synthesis.

37. The index d provides an estimate of effect for comparing means across studies.

= B. Study Questions

1. Read one of the following meta-analysis reports published several years ago as open- access articles (links to each paper are provided in the Toolkit 3):

¢ Atlantis, E., Fahey, P., & Foster, J. (2014). Collaborative care for comorbid depres- sion and diabetes: A systematic review and meta-analysis. BM] Open, 4, e004706.

° Lee, E.N., & Lee, J. H. (2016). The effects of low-dose ketamine on acute pain in an emergency setting: A systematic review and meta-analysis. PLoS One, 11(10), e0165461.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 30 © Systematic Reviews of Research Evidence 193

ordi ZaWZ Soltis seis X., ZhangiD), Linglix Tang, 'S:48o Chens lin (20114); Prevalence of suicidal ideation in Chinese college students: A meta-analysis. PLoS One, 9, e104368.

° Patil, S., Ruppar, T., Koopman, R., Lindbloom, E., Elliott, S., Mehr, D., & Conn, V. (2016). Peer support interventions for adults with diabetes: A meta- analysis of hemoglobin A,, outcomes. Annals of Family Medicine, 14, 540-551.

Then, search the literature for related quantitative primary studies published after this meta-analysis. Are new study results consistent with the conclusions drawn in the meta-analytic report? Are there enough new studies to warrant a new meta- analysis—or has a new review already been published?

. Read one of the following metasynthesis reports published several years ago as open-access articles (links to each paper are provided in the Toolkit @):

e Bridges, J., Nicholson, C., Maben, J., Pope, C., Flatley, M., Wilkinson, C., ...

Tziggili, M. (2013). Capacity for care: Meta-ethnography of acute care nurses’ experiences of the nurse-patient relationship. Journal of Advanced Nursing, 69, 760-772.

e Flores, D., Lebland, N., & Barroso, J. (2016). Enrolling and retaining human

immunodeficiency virus (HIV) patients in their care: A metasynthesis of qualita-

tive studies. International Journal of Nursing Studies, 62, 126-136. ¢ Kemp, K., Griffiths, J., & Lovell, K. (2012). Understanding the health and social

care needs of people living with IBD: A meta-analysis of the evidence. World Journal of Gastroenterology, 18, 6240-6249.

Then, search the literature for related qualitative primary studies published after

this metasynthesis. Are new study results consistent with the conclusions drawn in the metasynthesis report? Are there enough new studies to warrant a new metasyn- thesis—or has a new review already been published?

. Read the following open-access report, which involved a systematic review without a meta-analysis. Did the authors adequately justify their decision not to conduct a

meta-analysis?

e Zhao, Y., Brettle, A., & Qiu, L. (2018). The effectiveness of shared care in cancer

survivors—a systematic review. International Journal of Integrated Care, 18,

1-17.

. Read one of the following open-access articles (a link is provided in the Toolkit @). Use the critical appraisal guidelines in Box 30.1 (available as a Word document in the accompanying Toolkit @) to evaluate the integration.

e Audet, L., Bourgault, P., & Rochefort, C. (2018). Associations between nurse

education and experience and the risk of mortality and adverse events in acute

care hospitals: A systematic review of observational studies. International Journal

of Nursing Studies, 80, 128-146.

o(40,-OuU, 9), siong, WwW, Li Ye Win rl, lis oe Links (2018): Waist-hip ratio

as predictor of myocardial infarction risk: A systematic review and meta-analysis.

Medicine, 97, €11639.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

194 PART6 ® Building an Evidence Base for Nursing Practice

° Panda, S., Begley, C., & Daly, D. (2018). Clinicians’ views of factors influencing

decision-making for caesarean section: A systematic review and metasynthesis of

qualitative, quantitative, and mixed methods studies. PLoS One, 13(7), e0200941.

° Shiao, S., Lie, A., & Yu, C. (2018). Meta-analysis of homocysteine-related

factors on the risk of colorectal cancer. Oncotarget, 9, 25681-25697.

5. Identify a topic of interest and explore whether it might be possible to undertake a mixed studies review on the topic. Alternatively, investigate whether a mixed studies review might be feasible for one of the systematic reviews cited in Exercise B.4 (other than the one by Panda et al., which is a mixed studies review).

C. Application Exercises

EXERCISE 1: STUDY IN APPENDIX K

Read the report on the meta-analysis by Chase and colleagues (“The effectiveness of medication adherence interventions among patients with coronary artery disease”) in

Appendix K and then answer the following questions:

Questions of Fact

a. What was the stated purpose of this review? What were the independent and depen- dent variables in this review?

b. What inclusion criteria were stipulated? How many studies met all inclusion criteria? . What methods did the reviewers use to search for primary studies? . Did the authors present a flowchart showing the progression of potential studies through an identification and screening process? If no, was this information presented effectively in the text or in a table?

. How many study participants were there in total, in all included studies combined?

. What were the key demographic characteristics of participants in the primary studies?

. How many of the studies included in this meta-analysis used an experimental (ran- domized) design? How many were quasi-experimental?

. Did the researchers rate each study in the dataset for its quality? If yes, what aspects of the study were appraised? How many people evaluated the studies for quality? Was interrater agreement assessed?

. Did the researchers set a threshold for study quality as part of their inclusion criteria? If yes, what was it?

. What effect size measure was used in the analysis?

. Did the researchers perform any tests for statistical heterogeneity? Was a fixed effects or random effects model used?

. Were study-by-study effects presented in a forest plot? m. Overall, what was the value of the effect size for the interventions across all studies?

What was the confidence interval around the mean effect? Was the effect statistically significant?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 30 ® Systematic Reviews of Research Evidence 195

n. Considering the information in Figure 1, answer the following questions:

¢ In which study was the effect size the largest? Was this effect size statistically significant?

¢ Were effect sizes nonsignificant in any studies? ¢ Were there any studies where the effect size was in the opposite direction from

what was anticipated? o. Were subgroup analyses undertaken? If yes, what were the key findings? p. Did the researchers undertake a GRADE-type evaluation to assess confidence in the

findings?

Questions for Discussion

a. Was the size of the sample (studies and subjects) sufficiently large to draw conclu- sions about the overall intervention effects and about subgroup effects?

b. What other subgroups might have been interesting to examine (assume there was suf- ficient information in the original studies) ?

c. How would you assess the overall rigor of this meta-analysis? d. Based on this review, what is the evidence regarding interventions for medication

adherence among patients with coronary artery disease? e. Comment on the authors’ discussion of study limitations. f. Comment on the authors’ discussion of the implications of this meta-analysis for clin-

ical practice.

EXERCISE 2: STUDY IN APPENDIX L

Read the report on the metasynthesis by Beck (“A metaethnography of traumatic child- birth”) in Appendix L. Then answer the following questions:

Questions of Fact

a. In what way was this metasynthesis different from a typical metasynthesis? b. Is this synthesis aggregative or interpretive? c. What was Beck’s position in the controversy regarding integration across different

research traditions? d. Were the data in the primary studies derived from interviews, observations, or both? e. How many mothers participated in the six primary studies? f. What approach was used to conduct this metasynthesis? Was the analytic process

described? g. Was a metasummary performed?

h. How many shared themes were identified in this meta-synthesis? What were those

themes? i. Was Beck’s analysis supported through the inclusion of raw data from the primary

studies?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

196 PART6 ® Building an Evidence Base for Nursing Practice

Questions for Discussion

a. Was the size of the sample (studies and subjects) sufficiently large to conduct a mean-

ingful metasynthesis? Comment on the extent to which the diversity of the sample

enhanced or weakened the metasynthesis. b. Did the analysis and integration appear reasonable and thorough? c. Were primary studies adequately described? d. How would you assess the overall rigor of this metasynthesis? What recommenda-

tions would you make to improve its quality? e. Does the use of a figure included in a metasynthesis have any advantages for the

readers? f. What are the advantages or disadvantages of Beck conducting a metasynthesis on all

of her own qualitative studies? g. Based on this metasynthesis, what is the evidence regarding the experiences of birth

trauma for mothers?

= D. The Toolkit 54)

For Chapter 30, the Toolkit G9 on thePoint’ contains a Word file with the following:

¢ Guidelines for Critiquing Systematic Reviews and Metasyntheses (Box 30.1 of the textbook)

Guidance on Eligibility Criteria for Primary Studies in a Systematic Review Outline of a Protocol for a Cochrane Systematic Review Logic Grids for a Search for a Systematic Review

e Example of a Data Extraction Form for a Meta-Analysis e Selected Formulas for Calculating a Standardized Mean Difference Effect Size (d) e Example of a Summary Risk-of-Bias Graph e Example of a Summary Risk-of-Bias Table in a Systematic Review ¢ Cochrane Collaboration Handbook for Systematic Reviews of Interventions.

Version 6.0: Overview

¢ Comparison of Risk of Bias Assessment in the Cochrane Collaboration Reviewer’s Manual, Version 5.1 (RoB1) versus Version 6 (ROB2)

¢ Template for Flow Diagram for Inclusion of Primary Studies (as recommended in PRISMA)

¢ Example of a GRADE Evidence Profile from a Fictitious Meta-analysis e Template (Example) for a Table Summarizing Characteristics of Studies Included in

a Meta-Analysis or Systematic Review

e Template (Example) for a Summary Table for a Metasynthesis ¢ Template (Example) for a Table Summarizing Meta-Findings in a Metasummary e Example of a Meta-Aggregation Figure

¢ Links to useful websites for Chapter 30 ¢ Links to relevant open-access journal articles for Chapter 30

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 31

Applicability, Generalizability,

and Relevance: Toward Practice-

Based Evidence

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 31. (Puzzles may be removed for easier viewing.)

w 3S

ne. 2 Le es oat ar

| 23 24 ee ~

GGG gaa i] oo “fe bs ci

Generating and Assessing Evidence for Nursing Practi ice (11th ed.)

198 PART6 ® Building an Evidence Base for Nursing Practice

ACROSS

ily is the degree to which research evidence can be applied to individu-

als, small groups, or local contexts. '

Te -centered research focuses on the development of evidence that is

meaningful and valuable to clients.

9, When responses to an intervention vary, this is called geneity of treatment

effects. 10. Single subject experiments are also called N 1 designs. 11. The statistical index for dichotomous outcomes that experts have suggested are

important in understanding treatment effects is the (acronym). 12. A type of sequential trial design that is used in the development of adaptive interven-

tions is called ‘ se eee ae eiaees -2 is the acronym for a tool used to score the location of a trial on the

pragmatic-explanatory continuum.

16. A -response analysis can sometimes shed light on diversity in responses

to a treatment. 1SSMRSinvolveseeleer? — cation of a population using multiple indicators to

assess diversity in treatment effects. 19. When treatment effects are varied, researchers can attempt to unravel

(acronym).

' Ne is a framework for optimizing interventions that involves multiple ie phases (acronym).

25. Information about treatment effects from RCTs can be misleading if A there is great diversity in response to an intervention.

27. A(n) intervention is one in which there are multiple decision

points over time.

29. A framework called | phase optimization is sometimes used to target inter-

ventions more effectively.

DOWN

2. A(n) trial has features that are designed to enhance the generalizability and relevance of evidence about an intervention.

3. Researchers should report information about the research __ | t so that read-

ers can understand whether evidence is relevant to their circumstances. 4. The proper analysis for testing subgroup effects is to test for a(n)

with the treatment variable. 5. In a sequential, multiple assignment trial, researchers identify a(n) vari-

able to guide treatment decisions.

6. If researchers want to test the hypothesis that men and women have different responses to an intervention, they would undertake a(n) analysis.

8. effectiveness research involves comparing the effects of alternative interventions.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 31 ® Applicability, Generalizability, and Relevance: Toward Practice-Based 199

14.

15:

20.

Pap:

23%

24.

26. Deep

An intermediate tailoring variable often involves an assessment of whether or not a trial participant is a(n) ____ to the initial treatment. A large, complex dataset is sometimes referred to as data. Traditional RCTs emphasize internal validity, often at the expense of validity.

One possible design for a crossover single-subject experiment is When researchers undertake multiple subgroup analyses, there is a strong al of a(n) error.

A multivariable prediction tool can enhance applicability by helping to disentangle differences in response to a treatment. The framework can be used to guide the design and implementation of an evaluative study that seeks information about generalizability of the evidence. Precision healthcare initiatives have been driven by advances in ics. The is an index of clinical significance at the group level.

= B. Study Questions

ils Read one of the following studies, which are published as open-access articles (a link is available in the Toolkit @). To the best of your ability, score the study on the PRECIS-2 scale, which is available in the Toolkit @. Compare your scoring with that of other students. (Note that these articles do not provide sufficient information to score all elements of PRECIS-2.)

¢ Chaboyer, W., Bucknall, T., Webster, J., McInnes, E., Gillespie, B., Banks, M., ... Wallis, M. (2016). The effect of a patient centred care bundle intervention on pres- sure ulcer incidence (INTACT): A cluster randomised trial. International Journal

of Nursing Studies, 64, 63-71. e Duncan, P., Bushnell, C., Rosamond, W., Jones-Berkeley, S., Gesell, S.,

D’ Agostino, R., ... Vetter, B. (2017). The Comprehensive Post-Acute Stroke

Services (COMPASS) study: Design and methods for a cluster-randomized prag-

matic trial. BMC Neurology, 17, 133. e Pickham, D., Berte, N., Pihulic, M., Valdez, A., Mayer, B., & Desai, M. (2018).

Effect of a wearable patient sensor on care delivery for preventing pressure injuries in acutely ill adults: A pragmatic randomized clinical trial. International

Journal of Nursing Studies, 80, 12-19.

. Read one of the following open-access journal articles that reports a randomized controlled trial (a link to these studies is available in the Toolkit @). Were subgroup analyses performed? If no, should they have been? If yes, evaluate the extent to which the subgroup analyses conformed to the advice provided in the textbook.

M. (2018). Evaluation of a midwifery initiated oral health-dental service program

to improve oral health and birth outcomes for pregnant women: A multi-centre

randomised controlled trial. International Journal of Nursing Studies, 82, 49-57.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

200 PART6 #® Building an Evidence Base for Nursing Practice

e Sandlund, C., Hetta, J., Nilsson, G., Ekstedt, M., & Westman, J. (2018). Impact

of group treatment for insomnia on daytime symptomatology: Analyses from a randomized controlled trial in primary care. International Journal of Nursing

Studies, 85, 126-135.

e Senoi, D., & Aslan, E. (2017). The effects of cold application to the perineum on

pain relief after vaginal birth. Asian Nursing Research, 11, 276-282.

3. Read the following open-access journal article that reports a comparative effective- ness study (a link to these studies is available in the Toolkit 9). To what extent

were the six “defining characteristics” of CER, as described in Chapter 31, embod-

ied in the study?

e Furuya, E., Cohen, B., Jia, H., & Larson, E. (2018). Long-term impact of universal

contact precautions on rates of multidrug-resistant organisms in ICUs: A comparative

effectiveness study. Infection Control & Hospital Epidemiology, 39, 534-540.

4. Read one of the following open-access articles that reports a trial or a protocol for a trial (a link to these studies is available in the Toolkit @). Use the guidelines in Box 31.1 of the textbook (available as a Word document in the Toolkit @) to critically appraise the study’s applicability, generalizability, and relevance:

e Ayerle, G., Schafers, R., Mattern, E., Striebich, S., Haastert, B., Vomhof, M.., ...

Seliger, G. (2018). Effects of the birthing room environment on vaginal births and

client centred outcomes for women at term planning a vaginal birth. Trials, 19, 641.

¢ Darvish, A., Khodadadi-Hassankiadeh, N., Abdoosti, S., Ghappandar Kashani, M.

(2019). Effect of text messaging-based psychiatric nursing program on quality of life in veterans with post-traumatic stress disorder: A randomized controlled trial. International Journal of Community-Based Nursing and Midwifery, 7, 52-62.

¢ McKinney, N., Virtue, S., Lewis, F., Willis, A., Pettyjohn, T., Harmon, L., &

Davey, A. (2018). Study protocol: A randomized control trial of African American families fighting parental cancer together. BMC Cancer, 18, 1140.

e Winters-Stone, K., Kenfield, S., Van Blarigan, E., Moe, E., Ramsdill, J., Daniel,

L., ... Chan, J. (2018). Effect of increasing levels of web-based behavioral support

with changes in physical activity, diet, and symptoms in men with prostate cancer: Protocol for a randomized controlled trial. JMIR Research Protocols, 7, e11257.

a C. Application Exercise

EXERCISE C: STUDY IN APPENDIX A

Read the report by Nyamathi and colleagues (“Achieving drug and alcohol abstinence”) in Appendix A. Then answer the following questions:

Questions of Fact

a. Were stakeholders involved in the development of the dialectical behavioral therapy- case management (DBT-CM) intervention?

CHAPTER 31 ® Applicability, Generalizability, and Relevance: Toward Practice-Based 201

(Ss

f. g.

. Is this study an example of comparative effectiveness research (CER)?

. Was this trial pragmatic?

. Did the researchers report their results in terms of absolute risk reduction (ARR) or number needed to treat (NNT)? If not, using data in the supplementary table for the complete case analysis, compute the ARR or NNT for the primary outcome (any drug use). A link to an online calculator is available in Table 31.2 of the Toolkit @. Did the researchers conduct any subgroup analyses? Did the researchers discuss the study’s generalizability? Did the researchers discuss the study’s applicability?

Questions for Discussion

(OY) leon i)

. Comment on the degree to which the study had the six characteristics of CER.

. Comment on how this trial might score on the PRECIS-2 scale, to the extent possible.

. Discuss the degree to which the measures used in this study were “pragmatic.”

. Comment on the rate of successful recruitment into this trial (as per the flow chart in the Supplement). How might this affect the internal and external validity of the study?

What subgroup analyses might be undertaken with the data from this study, using variables that the researchers measured?

D. The Toolkit 5

For Chapter 31, the Toolkit GY on thePoint’ contains a Word file with the following:

Guidelines for Critically Appraising a Study’s Applicability, Generalizability, and Relevance (Box 31.1 of the textbook)

Comparison of Features of the Traditional Model of Research and Comparative Effectiveness Research Risk-Stratified Analysis: Fictitious Example of Fall Outcomes in a Fall Prevention Intervention Trial, Stratified on Predicted Risk of Falling (Annotated Version of

Table 31.2 in Textbook)

The PRECIS-2 Wheel Links to useful websites for Chapter 31 Links to relevant open-access journal articles for Chapter 31

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 32

Disseminating Evidence:

Reporting Research Findings

= A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 32. (Puzzles may be removed for easier viewing.)

CHAPTER 32 ® Disseminating Evidence: Reporting Research Findings 203

ACROSS

i The guidelines used by many medical and health journals for reporting randomized controlled trials (RCTs).

3. Some schools permit students to prepare a(n) -format thesis that incorpo- rates articles ready to submit (or already submitted) for publication.

5. All reports should have a succinct, descriptive that provides guidance to prospective readers.

6. Most scholarly journals have a policy of blind peer of submitted manuscripts.

7. Traditional journals may impose a(n) _ _ _ argo period for depositing articles in open-access repositories.

8. Most traditional journals require authors to sign a copyright tr__§_ _ = form

prior to publication. 11. In qualitative reports, key __ are often used as subheadings in the results

section.

12. At professional conferences, research results can often be communicated visually in a(n) session.

13. A journal’s factor is the ratio between recent citations to a journal and recent citable articles published.

15. The traditional method of communicating research results at a conference is a(n) presentation to an audience of attendees.

16. Acronym for one of the top-ranking research journals listed in the nursing subset of the Journal Citation Reports.

17. Another highly ranked journal is the__ _ _ _ ean Journal of Cardiovascular

Nursing.

18. STROBE guidelines are to ___ _ experimental studies what the CONSORT guide-

lines are to RCTs.

19. Tbe author of a report is usually the lead author. 22. The traditional organization for quantitative reports is the format. 05. ee Peal balers ments give nonauthorship credit to individuals or institutions that

contributed to the study. 26. Presentations at conferences are enhanced through effective visual materials such as

Point slides. Dy eCOVEL to journal editors often include assurances that the manuscript has

not been submitted elsewhere. 28. Quantitative reports are more likely to be written in the ____ voice than qualita-

tive reports.

DOWN

1. The ————__ author is the author with whom journal editors communicate

during the review stage of the publication process.

Qe Thetinal phaseof-aresearch-project, the === phase, involves communi-

cation of study results.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

204 PART6 ® Building an Evidence Base for Nursing Practice

. Manuscripts submitted to a journal are usually subjected to review by

several experts in the field. ee of findings at conferences provides an opportunity to inter-

act with other researchers interested in similar problems. credit on a report should be based on a person’s having made a

substantial contribution to the study and to the writing and review of the

paper. . Decisions about acceptance or rejection of a manuscript are usually communicated

by a journal’s , The “im. CONSORT fond for . Papers or documents that are not (yet) pubiened . Most quantitative reports include statistical to summarize results efficiently. ;

. A(n) letter is sometimes sent to journal editors to ascertain their

interest in a manuscript.

. Associations sponsoring a conference usually issue a(n) “ for Abstracts” months before the conference.

. The acronym for the reporting guidelines for meta-analyses of non-RCT primary

studies is M_ _

= B. Study Questions

is The following sentences or titles have stylistic flaws. Suggest ways in which the sen- tences could be improved.

a. ICU nurses experience more stress than nurses on a general ward (t = 2.5, df = 148, p <.05).

b. “A Study Investigating the Effect of Primary Care Nursing on the Emotional Well-Being of Patients in a Cardiac Care Unit.”

c. The nonsignificant results demonstrate that there is no relationship between diet and hyperkinesis.

d. It has, therefore, been proved that people have a more negative body image if the age of onset of obesity is before age 20 years.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 32 ® Disseminating Evidence: Reporting Research Findings 205

The positive, significant relationship indicates that occupational stress causes sleep disturbances.

2. Suppose that you were the author of a research article with the titles indicated

below. For each, name two journals to which your article could be submitted for publication. At least one of the journals should be a specialty journal.

Gi d. c.

“Parental attachment to children with Down syndrome.” “Sexual functioning among the elderly: The lived experience of noninstitutional- ized men and women in their 80s.” “Comparison of nurses’ and patients’ perceptions of postoperative pain.”

“The effects of fetal monitoring on selected birth outcomes.” “Effectiveness of alternative methods of relieving pressure sores.”

3. Read one of the following open-access journal articles (a link is provided in the Toolkit @) and use the critical appraisal guidelines in Box 32.2 (available as a Word document in the accompanying Toolkit G9) to evaluate the presentation of the report.

= C.

Braga, L., Parreira, P., Oliveira, A., Monico, L., Arreguy-Sena, C., &

Henriques, M. (2018). Phlebitis and infiltration: Vascular trauma associated

with the peripheral venous catheter. Revista Latino-Americana de Enfermagem, 26, e3002. Gejo, N., Weidearegay, H., Tinsale, K., Mekango, D., Woldemichael, E., Buda,

A., ... Goba, G. (2019). Exclusive breastfeeding and associated factors among

HIV positive mothers in Northern Ethiopia. PLoS One, 14, e0219782.

Straiton, M., Ledesma, H., & Donnell, T. (2018). “It has not occurred to me to

see a doctor for that kind of feeling”: A qualitative study of Filipina immigrants’ perceptions of help seeking for mental health problems. BMC Women’s Health,

£8. 73: Zwakhalen, S., Hamers, J., van Rossum, E., Ambergen, T., Kempen, G., & Verbeek, H. (2018). Working in small-scale, homelike dementia care: Effects

on staff burnout symptoms and job characteristics. A quasi-experimental, longitudinal study. Journal of Research in Nursing, 23, 109-122.

Application Exercises

STUDIES IN APPENDICES A—M

Answer the following questions with regard to the 13 research reports included in

appendices in this Resource Manual:

Generating and Assessing Evidence for Nursing Practice (11th ed.)

206 PART6 ® Building an Evidence Base for Nursing Practice

Questions of Fact

a. Were any articles in the appendices published in journals that do not have animpact

factor rating? b. Which articles in the appendices were published in journals that had an impact factor

greater than 1.00 in 2018—as shown in the table in Supplement B to Chapter 32 on

thePoint’? c. Which, if any, of the articles in the appendices deviated from a traditional IMRAD

format? d. In articles that were multiply authored, were the authors listed alphabetically? e. Which, if any, of the reports used first-person narratives to describe aspects of the

study methods or results?

Questions for Discussion

a. Comment on the extent to which the abstracts for the studies in the appendices adequately described the population of interest and key features of the research design.

b. Which report title had the greatest appeal to you—that is, which one most intrigued you and made you want to read about the study?

c. Select one or two reports and comment on how effectively the authors used figures and tables to enhance or streamline communication.

= D. The Toolkit 3

For Chapter 32, the Toolkit @9 on thePoint’ contains a Word file with the following:

¢ Guidelines for Critically Appraising the Presentation of a Research Report (Box 32.2 of textbook)

¢ CONSORT 2010 Guidelines: Checklist for Reporting a Randomized Controlled Trial

¢ CONSORT 2010 Guidelines: Template of a CONSORT 2010 Flow Chart Showing Participant Progression Through a Study

e Links to useful websites for Chapter 32 ¢ Links to relevant open-access articles for Chapter 32

CHAPTER 30

Writing Proposals to Generate

Evidence

# A. Crossword Puzzle

Complete the crossword puzzle below, which uses terms and concepts presented in Chapter 33. (Puzzles may be removed for easier viewing.)

et .

_ nn

| an

S| SS)

iS) iJ

Generating and Assessing Evidence for Nursing Practice (11th ed.)

208 PART6 ® Building an Evidence Base for Nursing Practice

ACROSS

3. In applications to NIH, the study purpose is described in the section called

Aims. e) costs are the costs of a project over and above specific project-related

costs. 8. costs are specific project-related costs.

NO tO

. The funding mechanism that gives researchers considerable discretion in what to

study and how best to study it. . A mechanism that agencies or organizations use for soliciting grant application

using broad guidelines about the type of projects of interest (acronym). . In the United States and most countries, the entity that funds most research (abbr.). . A type of NIH award for institutions that have not historically recetved much NIH

funding is an R1S or grant (acronym).

. Applications to NIH typically go through rounds of review.

. A frequent criticism by peer reviewers of grant applications to NIH is insufficient

work. . The form used for NIH grant submissions is the __ __ 424. . It is prudent to consider whether there is a current “hot ” that will make a

grant application more appealing to reviewers.

weihe ROS. or Grant Program, is mainly for pilot or feasibility studies

(backwards).

. Indirect costs, or , are institutional costs associated with doing research (e.g., for space, administrators, etc.).

. Acronym for an NIH award program, and often associated with the name “Ruth Kirschstein.”

. Grant applications are reviewed by a(n) and secondary reviewer prior

to the meeting date, whose preliminary scores affect whether an application will be formally scored at the review meeting.

DOWN

14.

Lvs

In the NIH scoring system, a reviewer’s score for a criterion signifying “exceptional.” The set of skills needed to secure funding for a research project. The informal name for an NIH peer review group (two words).

The funding mechanism for a specific study that a government or entity wants to have done, in which only one award is typically made.

The formal name for a peer review panel for NIH (acronym). Writing proposals is time-consuming, so a good strategy is to early!

. Scored grant applications to NIH are given a(n) score that reflects aver- age ratings of merit by all reviewers, multiplied by 10.

budgets, paid in blocks of $25,000, are appropriate for most NIH applications requesting $250,000 or less per year of direct costs. NIH F-series awards are for fellowships. Each applicant to NIH is sent a(n) sheet that includes reviewers’ comments.

CHAPTER 33. ™ Writing Proposals to Generate Evidence 209

=» B. Study Questions

1. Appendix N contains a successful grant application by Deborah Dillon McDonald: “Older adults’ response to health care practitioner pain communication” (All of the exercises in Part C refer to this proposal). Read the description of the proposed study in Appendix N. Then compare it to the methods described in the article that McDonald and colleagues wrote to report findings of the completed study. The report is available in an open-access article, and a link to it is provided in the Toolkit @:

¢ McDonald, D. D., Shea, M., Rose, L., & Fedo, J. (2009). The effect of pain

question phrasing on older adult pain information. Journal of Pain @ Symptom Management, 37, 1050-1060.

2. Go to the NIH Research Portfolio Online Reporting database (http://projectreporter. nih.gov/reporter.cfm) and find an NINR-funded grant nearing completion, on a topic that interests you. You can “select” many fields on the request form, such as a

date range and a study section (e.g., “Nursing and Related Clinical Sciences”) and then submit the query to obtain a list that shows the name of the project and the principal investigator (PI). Contact the PI to inquire about any conference presenta- tions or published papers that have resulted from the grant.

3. Appendix O contains portions of a successful grant application by Dr. Xiaomei Cong entitled “Multi-omics analysis of pain/stress impact on neurodevelopment

in preterm infants.” Read the project summary in the appendix. Then read one or both of the following papers that helped lay the foundation for Dr. Cong’s project (both papers are open-access papers, and links to them are included in the Toolkit @):

¢ Cong, X., Judge, M., Xu, W., Diallo, A., Janton, S., Brownell, E., Maas, K., &

Graf, J. (2017a). Influence of feeding type on gut microbiome development in hos- pitalized preterm infants. Nursing Research, 66, 123-133.

¢ Cong, X., Wu, J., Vittner, D., Xu, W., Hussain, N., Galvin, S., ...Henderson, W.

(2017b). The impact of cumulative pain/stress on neurobehavioral development of preterm infants in the NICU. Early Human Development, 108, 9-16.

a C. Application Exercises

EXERCISE 1: APPENDIX N

Appendix N contains a successful grant application, “Older adults’ response to

health care practitioner pain communication.” This application was submitted by

Dr. Deborah Dillon McDonald to NINR for funding under a program announce-

ment PA-03-152, “Biobehavioral Pain Research.” Before reviewing Dr. McDonald’s

grant application and the associated materials in Appendix N, scan the Program

Generating and Assessing Evidence for Nursing Practice (11th ed.)

210 PART6 ® Building an Evidence Base for Nursing Practice

Announcement (http://grants.nih.gov/grants/guide/pa-files/pa-03-152.html) and then

answer the following questions:

a. Did this PA fund projects through the RO1 mechanism only? b. When did this program announcement expire? c. Did other institutes within NIH, besides NINR, participate in this program

announcement?

d. Were institutions other than universities eligible to apply? Would a city government

be eligible? e. Would applicants be required to use the SF424 application package?

EXERCISE 2: APPENDIX N

Read through the grant application forms and research proposal submitted by Dr. McDonald in Appendix N. (Note that this application was submitted on form PHS 398, the paper form that was used before the SF424 electronic filing form became mandated. Also, the scoring of applications at that time was different, with scores ranging from 100 for the highest possible score to 500 to the lowest possible score.) Then answer the following questions:

Questions of Fact

a. What were the total direct costs requested for the entire research project for all project years? What are the total requested funds, for both direct and indirect costs?

b. What were the proposed timeframes for the study? c. How many people were listed as key personnel for the proposed study? How much of

the PI’s time was proposed for this project? d. Did the research plan section of the grant application conform to the page restrictions

for this PA? e. In what section of the application did McDonald present her hypothesis? Is this

placement consistent with guidelines? f. In what section did McDonald describe her own prior research relating to pain

communication? How many relevant prior studies had she undertaken? g. McDonald divided her “Research Design and Methods” section into several subsec-

tions. What are they?

h. What type of research design did McDonald propose? 1. What sample size did McDonald propose? Was the sample size based on a power

analysis?

j. According to the proposal, who would be blinded in this study?

k. Did the application stipulate that a stipend would be given to participants? If yes, what incentive would be offered?

|. In the analysis plan, were any multivariate analyses proposed? If so, what type of analysis would be undertaken?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CHAPTER 33. ® Writing Proposals to Generate Evidence 211

Questions for Discussion

a. Before reading any of the reviewers’ comments, critique McDonald’s proposed design, sampling plan, data collection, and data analysis strategies. Then compare your comments with the reviewers’ comments about the proposed methods.

b. What do you think the weakest aspect of the proposed project is?

EXERCISE 3: APPENDIX N

Appendix N also includes the summary sheet for McDonald’s grant application, together with McDonald’s response to reviewers’ concerns. Read through these materials and then answer the following questions.

a. The application number indicates the NIH funding mechanism for the proposed project. What was the funding mechanism?

b. Which study section reviewed the grant application? (Note that this study section no longer exists).

c. What was this grant application’s priority score? (Note that this application was

scored under an earlier system; in that system, scores under 200 were competitive).

d. What was the primary concern of the study section—that is, what part did they deem “unacceptable,” requiring McDonald to elaborate on proposed methods?

EXERCISE 4: APPENDIX 0

Appendix O contains portions of a successful grant application, “Multi-omics analysis of pain/stress impact on neurodevelopment in preterm infants.” This application was

submitted by Dr. Xiaomei Cong to NINR for funding under a program announce- ment PA-16-160, “NIH Research Project Grant (Parent RO1).” Read the first page of the NIH-produced “Project Information” sheet for Dr. Cong’s grant application in Appendix O. Then answer the following questions:

a. Which study section reviewed the grant application? b. What were the total direct and indirect costs for this project for the fiscal year 2017? c. What were the proposed timeframes for the study?

EXERCISE 5: APPENDIX 0

Read the Specific Aims section of Dr. Cong’s grant application (and the “Project Summary”

on the second page of the Project Information sheet) in Appendix O. Then answer the fol-

lowing questions:

Questions of Fact

a. Did Cong conduct pilot or preliminary work relating to this project? Was that work

funded by NIH? |

b. Did Cong state any hypotheses? If yes, what was the primary hypothesis?

Generating and Assessing Evidence for Nursing Practice (11th ed.)

212 PART6 ®& Building an Evidence Base for Nursing Practice

. Is the proposed study cross-sectional or longitudinal?

. Is the proposed study experimental or observational?

. What are the PICO elements for this project?

. How will pain and stress events be measured? How will neurodevelopmental out-

comes be measured? g. What is the targeted sample for this study? Is any attrition expected? Was sample size

based on a power analysis?

= Go (SG)

Questions for Discussion

a. Discuss the proposed project in terms of innovativeness. b. Discussed the proposed project in terms of its rigor, to the extent possible.

EXERCISE 6: APPENDIX O

Read “Resume and Summary of Discussion” (1 page) and the page identifying reviewers’ concerns and Cong’s response. Then answer the following questions:

a. Comment on the grant application reviewers’ enthusiasms and concerns about this

project.

b. Did the reviewers raise concerns about (1) substantive aspects of the proposed proj- ect? (2) methodologic aspects? (3) ethical aspects? (4) budgetary aspects?

= D. The Toolkit $4)

For Chapter 33, the Toolkit @9 on thePoint’ contains a Word file with the following:

¢ Checklist for a Quantitative Grant Application ¢ Selected NIH Grant Application Forms (Not Fillable—for Review Purposes Only) e NIH Study Section Scoring Guidelines e Links to useful websites for Chapter 33

e Links to relevant open-access journal articles for Chapter 33

Generating and Assessing Evidence for Nursing Practice (11th ed.)

APPENDIX A

ACHIEVING DruG AND ALCOHOL ABSTINENCE AMONG RECENTLY INCARCERATED HOMELESS WoMEN A Randomized Controlled Trial Comparing Dialectical Behavioral Therapy-Case Management With a Health Promotion Program

Adeline M. Nyamathi ¢ SanghyukS. Shin e Jolene Smeltzer ¢« BenissaE.Salem e« Kartik Yadav e

Maria L. Ekstrand e SusanF. Turner e¢ Mark Faucette

> Background: Homeless female ex-offenders program. The primary outcome was drug and

(homeless female offenders) exiting jail and prison

are at a critical juncture during reentry and transi-

tioning into the community setting.

Objective: The purpose of the study was to

compare the effect of a dialectical behavioral

therapy-case management (DBT-CM) program with

a health promotion (HP) program on achieving drug

and alcohol abstinence among female parolees/

probationers residing in the community.

Methods: We conducted amulticenter parallel ran-

domized controlled trial with 130 female parolees/

probationers (aged 19-64 years) residing in the

community. randomly assigned to either DBT-CM

(n= 65) or HP (n= 65). The trial was conducted in

four community-based partner sites in Los Angeles

and Pomona, California, from February 2015 to

November 2016. Treatment assignment was carried

out using a computer-based urn randomization

alcohol use abstinence at 6-month follow up.

Results: Analysis was based on data from 116 par-

ticipants with complete outcome data. Multivariable

logistic regression revealed that the DBT-CM program

remained an independent positive predictor of de-

crease in drug use among the DBT-CM participants at

6 months (p= .01) as compared with the HP program

participants. Being non-White (p< .05) and having

higher depressive symptom scores (p< .05) were

associated with lower odds of drug use abstinence

(i.e., increased the odds of drug use) at 6 months.

Discussion: DBT-CM increased drug and alcohol

abstinence at 6-month follow-up, compared to an

HP program.

Key Words: case management - dialectical

behavior therapy - heaith promotion - incarceration -

substance use - women

Reprinted with permission from Nyamathi, A. M., Shin, S. S., Smeltzer, J., Salem, B. E., Yadav, 213

K., Ekstrand, M. L., ...Faucette, M. (2017). Achieving drug and alcohol abstinence among recently

incarcerated homeless women: A randomized controlled trial comparing dialectical behavioral therapy-

case management with a health promotion program. Nursing Research, 66(6), 432-441.

214 APPENDIXA #® DBT for Recently Incarcerated Homeless Women

Despite a decline in the correctional popula-

tion, more than 45% of California’s offenders

return to prison within the first year of release;

strikingly, within 3 years, the rate climbs to

73% (California Department of Corrections

and Rehabilitation, 2014). Among homeless

parolees, multiple challenges with mental

health issues, substance use addiction, unem-

ployment, and unstable housing conditions

impact successful reentry (Binswanger et al.,

2011). Illicit drug use is a contributing factor

to incarceration as well as homelessness (McNeil & Guirguis- Younger, 2012; Tsai,

Kasprow, & Rosenheck, 2013). However,

recently released offenders continue to have

unmanaged drug issues, with probationers

and/or parolees affected four to nine times higher when compared to their nonsupervised

counterparts (Fearn et al., 2016). Successful

drug treatment completion and dropout rates

are high with two-thirds not completing treat-

ment programs (Zerger, 2002).

A myriad of factors may account for drug relapse and recidivism (Salem, Nyamathi,

Keenan, et al., 2013). Among women, recid-

ivism associated with drug-related viola-

tions is greater than those of male offenders

(32% vs. 21%; Leukefeld et al., 2009). Few

gender-sensitive programs address drug and

alcohol use and recidivism behaviors (Salem,

Nyamathi, Idemundia, Slaughter, & Ames,

2013), which necessitates obtaining infor-

mation about how to effectively address the

unique needs of the homeless female ex- offender following release.

Given these findings, it is critical for policy- makers to engage homeless paroled adults in

behavioral interventions that not only reduce

risky behaviors, such as drug and substance

use, but enable positive coping and commu-

nication skills in the continuity of their life

course trajectory. In fact, there may be other

potential alternatives to decreasing negative

outcomes among recently released offenders with drug and alcohol addictions, such as

inclusion of behavioral interventions in treat-

ment settings. Dialectical behavioral therapy (DBT) is one effective behavioral intervention

for recently released offenders who are engaged

in risky behaviors, because it addresses the behavioral and emotional barriers to successful

completion of treatment programs.

DIALECTICAL BEHAVIORAL THERAPY

DBT has been shown to decrease treatment

dropout and risky behaviors among suicidal patients with borderline personality disorders

(Linehan et al., 2006). In prison settings, the

aim of DBT is to teach those who are incar- cerated how to dialectically think through and problem-solve during conflicting situations

(Berzins & Trestman, 2004). The Dialectical

Behavioral Therapy-Case Management

(DBT-CM) method includes four core mod-

ules: mindfulness, interpersonal effectiveness,

distress tolerance, and emotion regulation. As formerly incarcerated persons undergo the

process of addressing the four core modules

of DBT-CM, a change in thoughts and emo-

tions and an increase in adaptive behaviors and cognitive abilities occur, which will pre- vent the escalation of maladaptive behaviors

(Shelton, Kesten, Zhang, & Trestman, 2011).

In the female offender population, DBT

programs were evaluated for viability of the intervention in a prison setting for women

with bipolar disorder and the impact on crim-

inogenic risk and self-harm (Nee & Farman, 2005). The findings revealed significant improvement in the women receiving the DBT

program as compared to the control group

in criminogenic risk (e.g., impulsivity, anger,

locus of control, self-esteem, and emotion

regulation) and in the characteristics of the

global bipolar disorder syndrome (Nee &

Farman, 2005). A reduction in criminogenic

tendencies such as self-harm—as well as improvement in the management and quality

of life— resulted (Nee & Farman, 2005).

In this study, DBT-CM was implemented to assist homeless female offenders manage emotional dysregulation and maladaptive behaviors by combining mindfulness with structured cognitive-behavioral techniques. It was thought that once these women accept themselves and their past—as persons with a

APPENDIXA &

recent history of incarceration—they can start to reshapemaladaptive cognitions and reduce

the incidence of self-destructive behaviors as they work toward a successful future (Berzins

& Trestman, 2004; Linehan, 1993), but data

about efficacy are not available.

THEORETICAL MODEL

A nursing-orientated, theoretical frame-

work, the comprehensive health-seeking

coping paradigm (CHSCP), derived from the schema of coping and adaptation (Lazarus & Folkman, 1984) and the health-seeking and

coping paradigm (Schlotfeldt, 1981), guided the development of the study and the selection of intervention and instruments for this study

(Nyamathi, 1989). The CHSCP model guided

the selection of the following factors: sociode- mographic, situational, social, personal, and

health-seeking and coping behaviors. Sociodemographic factors that may relate

to study outcomes included age, race/ethnic-

ity, education, and employment status. Social factors (social support) and health-seeking and coping factors such as treatment readi-

ness, and coping methods, such as program attendance and retention in program, were

also considered. Situational factors, such as

homelessness (Nyamathi et al., 2011) and his-

tory of criminal activities, as well as personal

factors, such as a history of depression and substance use, may be barriers for homeless

ex-offenders in completing the community

residential drug treatment (RDT) programs and successfully reentering the community.

PURPOSE

The primary purpose of this study was to

determine the effect of a DBT-CM interven- tion program versus a health promotion (HP)

programon drug use abstinence among home-

less female parolees/probationers at 6-month follow-up. Wehypothesized that DBT-CM intervention will increase the odds of absti-

nence to drug use during the 6-month study

Reprinted

with permission.

DBT for Recently Incarcerated Homeless Women 215

period compared to the HP program. As

secondary objectives, we examined the effect

of the intervention on abstinence from alcohol use and combined drug/alcohol use. Lastly, we aimed to identify baseline predictors of outcome success (abstinence).

@ Methods

DESIGN, SAMPLE, AND SITE

In total, 130 homeless female offenders from

four community based partner sites, which

included RDT programs, shelters, and service centers in Los Angeles and Pomona, California,

were enrolled from February 2015 to November 2016. Eligibility criteria were as fol-

lows: (a) having used drugs prior to their most recent incarceration, (b) ages 18-65 years, and

(c) were considered homeless prior to discharge from incarceration. The CONSORT flow diagramis available (see Figure, Supplemental

Digital Content 1, found at the end of this article and also at http://links.lww.com/NRES/

A276). As shown in the figure, 176 homeless

female offenders were screened and 46 home- less female offenders were excluded, of which

34 were ineligible based on screening criteria

of homelessness, history of drug use, or time since arrested. The remaining 12 were eligible

but did not complete the second consent to be randomized into the study; hence, they were

not enrolled. The study was approved by the university’s institutional review board and

registered with ClinicalTrials.gov.

PROCEDURES

Potential participants were informed about the

study using posted flyers and a brief informa- tion session by the research staff. Women who

were interested in more details were invited to attend one-on-one sessions in a private loca- tion. If they were interested in continuing, a

brief consent script was read and signed, and a

screener was administered by the research staff.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

216 APPENDIXA ® DBT for Recently Incarcerated Homeless Women

Among eligible women who requested partic-

ipation, a detailed informed consent was read

and discussed, and questions were answered by the research staff. A 45-minute baseline survey

was administered, followed by the request for

a urine sample to assess for drug use. After the baseline administration, the

participants were randomized to the DBT-CM

Behavioral or HP programs based on age strata and levels of the Lifestyle Criminality

Screening Form scoring using urn randomiza-

tion (Stout, Wirtz, Carbonari, & Del Boca,

1994). Both the programs were delivered

over 3 months. Cash incentives in the amount

of $3 for the initial screening, $15 for the baseline, and $35 for the follow-up surveys

were provided. In addition, participants were

provided $3 for each of the six groups and 6

one-on-one sessions. Those who completed

all 12 sessions received a $5 bonus. A 90% follow-up completion rate was achieved.

PROGRAM DEVELOPMENT

Development of the DBT-CM and HP pro- grams utilized elements of community-based participatory research, which established a

community advisory board (CAB) with com-

munity stakeholders, criminal justice experts,

social service providers, and academicians. The CAB modified a semistructured interview guide, which had been developed based on previous

research, the literature, and in consultation

with community and criminal justice experts.

Subsequent to the CAB, focus groups were

conducted among homeless female offenders to

understand their perspectives (Nyamathi et al.,

2016). Thereafter, two manualized programs were developed for the DBT-CM and an HP

program group and one-on-one sessions.

RESEARCH STAFF TRAINING-COMPETENCY CHECKLIST

Six research staff, which included community

health workers (CHWs; n = 4) and nurses

(RNs; 2 = 2), were intensively trained through

a standardized procedure over 10 days. In order to ensure provider skill acquisition

andminimize “drift” in provider skills (Bellg et al., 2004), a competency checklist was

developed uniquely for this study, which the project director utilized, to rate the research

staff on a Likert-type scale of 4 = excellent, 3 = good, 2 = okay, and 1 = needs

improvement.

TREATMENT FIDELITY MONITORING

Both groups were monitored for fidelity in group and one-on-one sessions using a Likert-

scale checklist—with response options of

excellent, good, fair, and poor—that assessed

the following: (a) management of the session,

(b) group content preparation, (c) clarity, and (d) environment. Treatment fidelity ensured

the same treatment dose within conditions

and ensured equivalent dose across condi- tions. The project director regularly observed

and assessed fidelity by rating each core com-

ponent for the DBT-CM and HP groups and

one-on-one sessions.

EXPERIMENTAL CONDITIONS

DBT-CM Intervention. The program

consisted of six weekly group sessions (with five to seven individuals per group) and six

weekly one-on-one sessions, each lasting,

on average, 45-60 minutes, for a total of

12 weeks. Furthermore, ongoing contact

with the research staff was encouraged on a weekly basis over the 6-month period. The six DBT-CM sessions were organized into the

following topics: (a) avoiding and eliminating

cues to use, (b) burning bridges to substance

use, (c) building a life worth living, (d)

observing urges, (e) adaptive denial, and (f)

alternative rebellion. In addition, each session

included signing in, mindfulness, and diary card/review of homework. The focus of the

one-on-one sessions was on utilizing a diary

card, organizing treatment targets, setting an

agenda, chain analysis, and solution analysis.

APPENDIXA &

Furthermore, participants were assisted with referrals and in identifying risk factors that trigger use of substances and housing over the 6-month program. For additional informa- tion, see Document, Supplemental Digital Content 2, found at the end of this article and

also at http://links.lww.com/NRES/A277.

HP Program (Comparator). For participants

assigned to the HP program, a dedicated

nurse and two CHWs were trained to deliver a program focused on common chronic

diseases that homeless women face and HP activities for these chronic diseases. Similar to the DBT-CM program, the women met

in small groups of five to seven at a time to discuss a particular chronic disease as well

as in one-on-one sessions with the nurse or

CHW to discuss more personalized strate- gies. The six HP sessions, conducted weekly,

focused on: (a) diabetes; (b) heart disease;

HIV; (d) parenting skills; (e) community and

family reintegration; and (f) other topics. The program was delivered over 12 weeks; there was no ongoing meeting of the participants in

relation to referrals and support.

VARIABLES AND MEASUREMENT

Sociodemographic and Situational

Factors. Site was noted; age, race/ethnicity,

employment status, and education were self-

reported. Incarceration history was obtained

using the Lifestyle Criminality Screening Form (Walters, White, & Denney, 1991); the

number of times in jail or prison and whether the participant was currently on probation or

parole were obtained.

Social and Personal Factors. Social support

was measured using the 19-item Medical

Outcomes Study Social Support Survey; a

5-point Likert-type scale was used. Cronbach’s

alpha was .97 in the development sample (Sherbourne & Stewart, 1991). Total scores

were summed; higher scores meant higher

social support. Relationship with family was

Reprinted with permission.

DBT for Recently Incarcerated Homeless Women 217

self-reported using the Women’s Risk Needs

Assessment (WRNA; Wright, Van Voorhis,

Bauman, & Salisbury, 2008). A sample item is

“How is your relationship with your family?” Response options ranged from0 = conflict-

ual some or most of the time to 1 = good, just minor conflicts. Emotional well-being was assessed using the Mental Health Index

(Stewart, Hays,& Ware, 1988). Reliability esti-

mates from .74 to .85 were reported among

homeless and drug-using samples (Nyamathi, Leake, Longshore, & Gelberg, 2001). Item

scores were summed and then linearly transformed to a 0-100 range; higher values

indicated better emotional well-being. In this

study, Cronbach’s alpha was .87. Treatment readiness was measured using

the eight-item Client Evaluation of Self and

Treatment, using a 5-point Likert scale (Joe, Broome, Rowan-Szal, & Simpson, 2002).

A sample item is “This treatment program can really help you.” Answers to items for each scale were averaged and then multiplied

by 10. Scores ranged from 10 to 50, with scores above 30 indicating greater treatment

readiness. Depressive symptomology was measured

with the 10-item short form of Center for Epidemiologic Studies-Depression Scale (CES-D), which asks individuals how they

felt or behaved in the last week (Andresen,

Malmgren, Carter, & Patrick, 1994). Sample

item included “I was bothered by things that

usually don’t bother me.” Responses ranged from 0 = rarely or none of the time (less than

1 day) to 3 = most of the time (5-7 days).

Items cores were summed, resulting in a range for the total score from 0 to 30, with higher

scores for greater depressive symptoms. The scale was dichotomized at the suggested cut

point of >10 (Zhang et al., 2012) to indicate

a need for psychiatric evaluation. In this sam- ple, Cronbach’s a was .82. Anger and hostility

were measured with questions on the WRNA

(Wright et al., 2008); items addressed temper,

trouble controlling temper, and anger/being

upset when committing the last offense since last incarceration. Responses were 1 = yes or

0 = no. Cronbach’s alpha for anger was .61.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

218 APPENDIXA ® DBT for Recently Incarcerated Homeless Women

Posttraumatic stress disorder was assessed using the four item subscale of the WRNA

(Wright et al., 2008); participants were asked

about experiences in the last month that were frightening, horrible, or upsetting. Responses

were 1 = yes or 0 = no. A score of “1” indi-

cated a serious mental health problem. In this

sample, Cronbach’s « was .84

Coping Behaviors. The Emotional

Regulation Modes of Coping Scale, with

5-point Likert-type response options, was

used to assess coping behaviors (Gratz & Roemer, 2004, 2008). Items range from 1

= almost never to 5S = almost always, with

some reverse-scored items. Total score for the scale was calculated by adding keyed

responses to all 36 items. The possible range was 40-140, with higher scores suggesting

greater problems with emotional regulation.

Sample subscales included Impulse Control

Difficulties (six items, « = .86), Lack of

Emotional Awareness (six items, « = .80),

and Limited Access to Emotion Regulation

Strategies (eight items, « = .88). A sample

item is “When I am upset, I become out of

control.”

Outcome Variables. The primary outcome

was drug use abstinence at the 6-month fol-

low-up visit. Abstinence was measured by

self-report and urine analysis. Participants

who reported being abstinent from drug

use during the past 6 months but tested

positive on urinalysis were coded as being not abstinent. Secondary outcomes were

alcohol abstinence and abstinence for both drugs and alcohol combined during the past 6 months. For the combined absti-

nence outcome variable, anyone who had reported any alcohol or drug received a “0”

and those who reported no use of drugs or alcohol received a “1.”

Alcohol and drug use was self-reported using the Texas Christian University Drug

History Form II (Institute of Behavioral Research, 2007). Frequency of alcohol and

drug use in the last 6 months was addressed.

Responses for frequency of use included “only

a few times,” “1-3 times a month,” “1-5

times a week,” and “about every day.” The vast majority of the participants reported no

use or “about everyday” (average of 94%

at baseline and 90% at 6 months across drug and alcohol use variables). Thus, we

used dichotomized responses as no use of drugs and alcohol (abstinent) or any use (not

abstinent). A five-panel Food and Drug

Administration-approved urine test cup

(Phamatech, Inc.) was used at baseline and

6-month follow-up. The test cup screened for metabolites of amphetamines, cocaine, meth-

amphetamines, 3,4-methylenedioxymethamph

etamine, opiates, and marijuana.

DATA ANALYSIS

Baseline characteristics were compared between the two programs using the Pearson’s

y’ test or the Fisher’s exact test for categorical variables. The Wilcoxon rank-sum test was used for continuous variables instead of t tests because many of the variables were not normally distributed.

Logistic regression modeling with generalized estimating equation was used

to compare changes in odds of drug use abstinence (primary outcome) during the

study period between the programs (Zeger

& Liang, 1986). Models were fitted with each outcome specified as the dependent variable, and program, time, and a Program x Time interaction term specified as inde- pendent variables. The coefficient for the Program x Time interaction corresponds to

the difference in change in abstinence among DBT participants compared to the change

in abstinence observed among HP partici- pants. This coefficient represents the effect of the DBT-CM intervention on improving

abstinence during the study period compared to HP. We then repeated this analysis for the secondary outcomes: alcohol abstinence

and abstinence to drugs and alcohol. The

APPENDIXA

primary analysis used the complete case

approach. Data from all participants ran-

domized to either program with complete

data for baseline and 6-month outcomes,

regardless of the level of adherence to pro- gram activities, were used. This approach

was used given the relatively high propor-

tion of participants with complete data for the outcome variable (89%).

We performed sensitivity analysis using the following approaches: (a) per-protocol anal-

ysis of only the participants who completed

program activities, (b) imputation of missing

6-month outcome data by carrying baseline values forward, and (c) multiple imputations under the missing at random assumption

(Jolani, Frank, & van Buuren, 2014; Rubin,

1987). For multiple imputation, logistic

regression modelling was used to impute miss-

ing outcome data sequentially with preceding data as predictors. Predictors included in the

model were attendance completeness, baseline

drug and alcohol use, baseline urinalysis

results, and outcome variables (drug use

and alcohol use at 6 months). Twenty-five

imputed data sets were generated, and analy-

sis done on the imputed data sets was pooled using the method described by Rubin (1987).

To assess the potential effect of confounding due to inadequate randomization, baseline characteristics that differed between the groups with p < .2 were evaluated in addi-

tional models. We also used logistic regression model-

ing to identify baseline predictors of drug use abstinence at 6 months. First, separate bivariate logistic regression models were fitted with demographic or psychosocial measures

as independent variables, and abstinence at 6

months was the dependent variable. Predictors

associated with the outcome with (p < .10) in

the bivariate model were evaluated in multi- variable logistic regression models in a forward

stepwise manner. The final model included only the variables found to be statistically sig- nificant independent predictors of abstinence (p < .05). Confounding was assessed by deter-

mining changes in the effect of DBT on drug

Reprinted with permission.

DBT for Recently Incarcerated Homeless Women 219

use abstinence after inclusion of the variable in

the multivariable model (Greenland, 1989). All

analyses were performed using R version 3.3.0.

Statistical tests were two-sided, and nominal p values of .0S were used to judge significance in the primary analysis.

# Results

PARTICIPANT CHARACTERISTICS

Participant characteristics are summarized in Table 1. Sixtyfive participants were enrolled into each group. There was no evidence of differences in baseline charac-

teristics. Most participants were Black or

Latina, and most were unemployed. In total,

70% of the participants were on proba-

tion at the time of enrollment. Participants reported moderate levels of social support

and coping behavior. Likewise, participants reported moderate scores on the Mental Health Index (68 on a 100-point scale) and

the posttraumatic stress disorder scale (M

= 1.8 for HP group and 1.5 for DBT-CM group; range 0-3); WRNA Relationship Scale scores were low (M = 5.1 for HP

group and 4.8 for DBT-CM group; range 0-12). Nearly half (44.6%) reported depres- sive symptomology.

At baseline, 67.7% in the DBT-CM group and 69.2% of the HP group used any drugs during the past 6 months based on self-report

with urinalysis (p = 1.00; Table, Supplemental Digital Content 3, found at the end of this article and also at http://links.lww.com/NRES/ A278). Marijuana and methamphetamines were the most frequently used drugs. Alcohol

use during the past 6monthswas reported by 41.5 %of the participants in both groups. Complete attendance (attendance at six group

sessions and at least six individual sessions)

was achieved by 89.0% of the DBT-CM par- ticipants and 84.0% of the HP participants. Retention at 6 months was 87.7% for the HP

group and 90.1% for the DBT-CM group.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

220 APPENDIXA ® DBT for Recently Incarcerated Homeless Women

Table 1 Participant Characteristics

HP (n= 65) DBT-CM (n= 65)

Type/characteristic n (%) n (%)

Demographic and situational

Education

<12 years 18 (27/7) Dal (32.3)

12 years or GED 26 (40) 27 (41.5)

Some college or vocation 15 (23.1) 13 (20)

College graduate 6 (9.2) 4 (6.2)

Race/ethnicity

White 11 (16.9) Ti (10.8)

Black 24 (36.9) 29 (44.6)

Latino 26 (40) 26 (40)

Other 4 (6.2) 3 (4.6)

Site

RDT Los Angeles 13 (20) 14 (21.5) Shelter/service 14 (21.5) 7 (10.8)

RDT Pomona 38 (58.5) 44 (67.7)

Employment (employed) 51 (78.5) 57 (87.7)

Parole (currently; yes) 7) (10.8) 7 (10.8)

Probation (currently; yes) 46 (70.8) 45 (69.2)

Prison (frequency)

Never 30 (46.2) 29 (44.6) Once 16 (24.6) 12 (18.5)

2-4 times 13 (20) 11 (16.9)

>5 times 6 (9.2) 13 (20)

Depression (CES-D = 10) 29 (44.6) PAS) (44.6)

Program attendance (complete) 55 (84.0) 58 (89.0)

Program retention (yes) 57 (87.7) 59 (90.1)

M (SD) M (SD)

Age (years) 38.6 (11.3) 39.1 (1125)

Psychosocial (scores)

Social Support 315 (1.1) 3.4 (1.0)

Impulse Control Difficulties 14 (5.7) 1SH5) (5.4)

Lack of Emotional Awareness IE (5.3) 14.1 (5.5)

Limited Emotion Regulation 173 (7) Ast (6.5)

CES-D 9.6 (6.1) 9.6 (6.7)

Mental Health Index 68.0 (22.6) 67.6 (23.1)

PTSD Score 1.8 (1.6) 1.5 (1.6)

Anger/Hostility 1.5 (ez) 1.4 (1.1)

Relationship 5.1 (3.4) 4.8 (3)

Depression/Anxiety 2? (2) 2.4 (2.1)

Treatment Readiness 40.4 (7.9) 40.1 (9.5)

Note. N = 130. All p-values were nonsignificant (p > .05). CES-D = Center for Epidemiologic Studies-Depression; DBT-CM = Dialectical Behavioral Therapy-Case Management; GED = general educational development; HP = Health Promotion; PTSD = posttraumatic stress disorder; RDT = residential drug treatment.

Generating and Assessing Evidence for Nursing Practice (11th ed.) with permission.

APPENDIXA ® DBT for Recently Incarcerated Homeless Women 221

PRIMARY ANALYSIS: PROGRAM SENSITIVITY ANALYSIS AND IMPUTATION EFFECTIVENESS FOR DRUG USE FOR MISSING DATA ABSTINENCE

Figure 1 shows the results of the complete At the 6-month follow-up visit, 65.5% (38/58) case analysis (primary analysis) and sensitiv-

of DBT-CM participants and 48.3% (28/58) ity analysis. In the per-protocol analysis of of HP participants were abstinent for drug only participants who completed all pro- use, based on urinalysis confirmation of self- gram sessions (7 = 53 for HP and n = S1 for report (Table 2). Drug abstinence increased at DBT-CM group), the DBT-CM treatment 6-month follow-up in both groups compared showed a greater effect on abstinence for to the baseline. However, the magnitude of the drug use (p < .05), alcohol use (p < .05), and increase in drug use abstinence was greater in substance use (p < .05) than the HP program.

the DBT-CM group compared to the HP group When missing outcome data at 6 months

(i.e., the interaction term was significant; were imputed by carrying the baseline data OR = 2.60, 95% CI [1.04, 6.53], p = .04). forward, the DBT-CM informed program had

greater effect on alcohol abstinence than the HP program (p = .02), whereas the differences

SECONDARY OUTCOMES between the two programs for substance abstinence (p < .11) did not reach statistical

Similarly, participants in the DBT-CM group significance. In multiple imputation analysis,

were more likely to become or remain alcohol- the difference effect between the DBT-CM abstinent during the study period (OR = 3.12, and HP groups did not reach statistical 95% CI [1.24, 7.85], p = .02); the HP group significance for any of the three outcomes

did not change. The differences in increased (Figure 1). Including months since last exit odds of substance abstinence (abstinent for from prison or jail (p = .10 between HP and

both drugs and alcohol) were not significant DBT-CM groups) into the models to account (i.e., the interaction term was nonsignificant; for possible lack of balance between the pro-

ORS 239; 99% QUOL2, G23, = OD). gram groups did not change our findings.

Table 2 Generalized Estimating Equation Logistic Regressions: Abstinence by Treatment Group at Baseline and 6-Month Follow-up With Differences in Change Over Time*

HP (n=58) DBT-CM(n=58) Treatment x Time interaction

Substance(s) Occasion n (%) n (%) OR 95% Cl p

Drug? Baseline 19 N20) 16 (27.6) 2.60 [1.04, 6.53] 04

6-month 28 ~=(48.3) 38 (65.5)

Alcohol Baseline 35 = (60.3) 33 (56.9) Baz [1.24, 7.85] .02

6-month 34 (58.6) 46 (79.3)

Substance® Baseline 7 (29%3)} 15 (25.9) 2.39 [0.92, 6.23] .07

6-month 26 = (44.8) 36 (62.1)

Note. Cl = confidence interval; HP = Health Promotion; DBT-CM = Dialectical Behavioral Therapy-Case

Management; OR = odds ratio; 6-month = 6-month follow-up. .

‘Estimated by Treatment x Time interaction in logistic regression models with generalized estimating equation.

bScored 0 for “not abstinent” if the participant tested positive for drug use in urinalysis regardless of self-reported

response. Use of illicit drugs or alcohol.

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

aS eS

222 APPENDIXA ® DBT for Recently Incarcerated Homeless Women

Drug use Alcohol abstinence abstinence

65.5% i 50- 399% eee °48.3% 96.9%

25- 27.6%

% Abstinent

Substance use

abstinence

8 $3

29.3% g =

25.9% e

- @

68.0% a

B209n eee ©46.0% 3

26.0% 8

oO p=02 — DBT ae a

63.1%

pJeMuo} peweo auljaseg 30.8% nee ©40.0%

ca 26.2% 0- p=.11

100- =

75- Hares 58.6% 58.5% 58.6% c =

50 Ty gpiang OS ter ©43.7% 30:8% ee °437% BS 25 pBOS er 26.2%° oo 0- p=.26 p=.07 pate oD =

Baseline 6 Month Baseline 6 Month Baseline 6 Month

Figure 1. Changes in outcomes for the Health Promotion versus Dialectical Behavioral Therapy-Case Man-

agement groups, showing the primary analysis using complete case data and sensitivity analyses. The p

values for the coefficient of the Intervention x Time Point interaction term estimated using logistic regres-

sion models with generalized estimating equation are shown.

BASELINE PREDICTORS OF DRUG USE ABSTINENCE

Using the p < .10 criterion in bivariate logistic regression models, DBT-CM program and Mental Health Index were associated with

drug abstinence at 6months. Factors associ-

ated with a reduced likelihood of 6-month drug abstinence included drug use at baseline;

Black, Latina, and other race/ethnicity versus

White; impulse control difficulties; CES-D

score; and depression/anxiety score. All vari-

ables associated with drug use abstinence with p < .10 in bivariate analysis were evaluated

for inclusion in the multivariable logistic regression model.

Table 3 shows the final multivariable logistic regression model, including all

variables associated with drug use abstinence

at 6 months (p < .05). DBT-CM program

remained a positive predictor of drug use abstinence at 6 months (aOR = 3.15, 95%

CI [1.30, 7.69], p = .01). Race/ethnicity was

also significant, with lower odds of drug use abstinence found for Black (aOR = 0.05, 95%

Cl [0.01, 0.50], p = .01), Latino (aOR = 0.08, 95% CI [0.01, 0.74], p = .03), and other race/

ethnicity (@OR = 0.05, 95% CI = [0.00, 0.64], p = .02) versus White. In addition, a higher

CES-D score was independently associated

with lower odds of drug use abstinence

(aOR=0.91 for 1 unit increase in CES-D

score, 95% CI [0.84, 0.98], p = .01). Race/

ethnicity was found to be a confounder for the association between the intervention and drug use abstinence, as adjusting for this factor led to an increase in the effect estimate for the intervention (OR = 2.04 in bivari-

ate model to aOR = 3.15 after adjustment;

Table 3). (The confounding occurred because a higher proportion of Black subjects were assigned to the DBT intervention [44.6% vs. 36.9%] for HP group. Because Black subjects were less likely to be abstinent at 6 months,

the unadjusted model resulted in an artificially attenuated odds ratio for the effect DBT on abstinence [unadjusted OR = 2.04]. The mul-

tivariable model accounts for the imbalance in racial composition between the DBT and

HP groups by statistically controlling for

APPENDIXA ® DBT for Recently Incarcerated Homeless Women 223

Table 3 Baseline Predictors of Drug Use Abstinence at 6 Months ee ea ee ee ee ee ee ee ee Bivariate Multivariate

Predictor OR 95% Cl p aOR 95% Cl p

Program

Health Promotion 1.00 1.00

Dialectical Behavior Therapy 2.04 [0.96,4.30] .06 Sei estO), W/E) 01 Drug use (any = yes, baseline) 0.28

Race/ethnicity (0.11, 0.68] .005 0.19 [0.07, 0.56] .002

White 1.00 1.00

Black OL07 e010, 0:59) 201 0.05 [0.01,0.50] .01

Latino O12 — Cor weal — Ws 0.08 [0.01,0.74] .03

Other O11 [(0.01, 1.40] .09 0.05 [0.00,0.64] .02

Impulse Control Difficulties 0.94 [0.88,1.00] .06

Mental Health Index 1.02 (100,104) 2

Depression/Anxiety (score) 0.76 [0.63,0.93] .006

CES-D (score) 0:93 [0:87,0:99] 02 0.91 (0.84, 0.98] .01

Note. N = 116. aOR = adjusted odds ratio; CES-D = Center for Epidemiologic Studies-Depression; CI = confidence interval; OR = odds ratio.

race/ethnicity [@OR = 3.15]. Similar effect

of race and ethnicity on drug use outcomes has been documented in other studies and is

addressed in the discussion.)

& Discussion

Guided by the CHSCP, the purpose of this randomized controlled trial was to determine

the effect of DBT-CM versus an HP pro- gram on abstinence from drug and alcohol

use among homeless female parolees/proba- tioners. To our knowledge, this is the first

study to demonstrate that a DBT-CM inter- vention compared to an HP program deliv-

ered by CHWs and RNs has been successful

in achieving higher rates of drug and alcohol abstinence at 6-month follow-up. The CHSCP

provided a framework to understand how the

DBT-CM influenced drug use abstinence. For many women who are offenders,

substance use, a maladaptive coping mecha-

nism during reentry, is an ongoing challenge, leading to further arrest and reincarceration

Reprinted

with permission.

(Cobbina, 2010; Freudenberg, Daniels, Crum,

Perkins, & Richie, 2005). Our previous,

qualitative research (Nyamathi et al., 2016; Salem, Nyamathi, Idemundia, et al., 2013)

and extensive community-based work have

informed the development of the DBT-CM

intervention and engaged collaboration between CHWs and RNs during reentry to

help homeless female offenders more success- fully transition into the community.

Informed by the CHSCP, one of the main

goals of the DBT-CM team was to replace maladaptive coping methods (i.e., substance

use) with more positive coping methods (i.e.,

burning bridges to substance use, positive social support, etc.). Given that reentry is a

critical time, health and social services should

be aimed at providing programs that will

address drug use, as it will likely reduce recid- ivism and decrease the likelihood of future

criminal justice involvement. During our

program, the DBT-CM team also provided targeted referrals that included employment,

education, housing, and health.

Given that a DBT-CM informed group appears to be an effective strategy for homeless

Generating and Assessing Evidence for Nursing Practice (11th ed.)

224 APPENDIXA @

female offenders during reentry, integration of this intervention at RDT sites should be further

tested in a larger-scale trial. Race/ethnicity

was an independent predictor of continued substance use, with those who self-reported as Black, Latina, or members of other groups more likely to continue to use than White women. This finding is consistent with the

CHSCP, which posits that situational factors

that cause psychosocial stress may lead to mal-

adaptive coping behaviors, including substance use. Black and Latino homeless women may

have higher levels of psychosocial stress due to perceived and experienced racial and,ethnic

discrimination, leading to increased substance

use (Carliner, Delker, Fink, Keyes, & Hasin,

2016). Similar findings were reported in a

previous intervention study among homeless persons that found that Black participants

were more likely to continue to use drugs at

follow-up compared to White participants

(Padgett, Stanhope, Henwood, & Stefancic,

2011). Gaining a greater understanding of dif-

ferences between racial and ethnic groups may inform modified approaches to improve out- comes for Black and Latina homeless women.

Furthermore, our findings demonstrated

that depressive symptomology was associ- ated with drug use at 6 months. This finding

is consistent with previous studies among

homeless women in Los Angeles County (Galaif, Nyamathi, & Stein, 1999; Tucker et

al., 2005) Under the CHSCP framework, sub-

stance use could be considered a maladaptive coping method to relieve the negative impact

of depression. These findings demonstrate the importance of addressing depressive sympto- mology among this population.

LIMITATIONS

Our findings relate to adult women offend- ers across a wide age span who resided in

Southern California. Our findings may not be generalizable across other parts of the United States. Likewise, our sample includes

women on two different types of conditional

release (probation and parole). Although our

Generating and Assessing Evidence for Nursing Practice (11th ed.)

DBT for Recently Incarcerated Homeless Women

sensitivity analysis showed a general pattern

that DBT-CM was more effective than HP in achieving the drug and alcohol use outcomes,

the effect size varied under different assump- tions and did not reach statistical significance in some cases. A larger randomized-controlled trial is needed to validate our findings and generate more robust estimates of the effect of

DBT-CM on drug and alcohol use.

CONCLUSIONS

Our intervention focuses on an understudied and often hidden group that is navigating between prison/jail and community reentry. Building upon these findings will necessi-

tate integrating a culturally sensitive lens to

identify differences among drug abstinence for Blacks, Latinas, and Whites. Another

important consideration is to conduct further

assessment on intake related to depression

and linkage into care during release. Future

studies necessitate a larger sample size and inclusion of a qualitative follow-up study

to gain a greater understanding of areas of improvement and need. Moreover, including

a cost effectiveness analysis of this program as compared with the cost of prison and other health issues may provide helpful information

for the design of future programs.

Adeline M. Nyamathi, ANP, PhD, FAAN, is Found-

ing Dean and Distinguished Professor, Sue & Bill

Gross School of Nursing, University of California,

Irvine. At the time this work was completed, she

was Distinguished Professor, School of Nursing,

University of California, Los Angeles.

Sanghyuk S. Shin, PhD, is Assistant Professor, Sue @& Bill Gross School of Nursing, University of

California, Irvine. At the time the work was com-

pleted, he was Assistant Professor-In-Residence,

School of Public Health, University of California, Los Angeles.

Jolene Smeltzer, MSN, RN, is Student, Mervyn

M. Dymally School of Nursing, Los Angeles, California.

Benissa E. Salem, PhD, MSN, RN, is Assistant

Adjunct Professor and Project Director, School of

Nursing, University of California, Los Angeles.

Reprinted

with permission.

APPENDIXA

Kartik Yadav, MSCR, is Project Director, Sue

& Bill Gross School of Nursing, University of

California, Irvine. At the time this research was

completed, he was Project Director, School of

Nursing, University of California, Los Angeles.

Maria L. Ekstrand, PhD, is Professor, School of Medicine, University of California, San Francisco.

Susan F, Turner, PhD, is Professor, Department

of Criminology, Law and Society, University of California, Irvine.

Mark Faucette, BS, is Vice President, Amistad de

Los Angeles, California.

Supplemental digital content is available for this

article in this book after this article. Direct URL

citations appear in the printed text and are

provided in the HTML and PDF versions of this

article on the journal’s Web site (www.nursingre- searchonline.com).

DOI: 10.1097/NNR.0000000000000249

Accepted for publication August 28, 2017. Clinical Trial Registration: Clinical Trials.gov

NCT02258425. Editorial note: Deborah Chyun was Action

Editor for this paper. This study was funded by the National

Institute on Drug Abuse (R34DA035409,

NIAID K01 AI118559). This project was supported by the National Center

for Advancing Translational Sciences, National Institutes of Health, through

Grant UL1 TR0001241.

The authors have no conflicts of interest to

report. Corresponding author: Adeline M. Nyamathi,

ANP, PhD, FAAN, BerkHall, Room

252D, University of California, Irvine

School of Nursing, Irvine, CA 92617

(e-mail: [email protected]).

REFERENCES Andresen, E. M., Malmgren, J. A., Carter, W. B., &

Patrick, D. L. (1994). Screening for depression in well older adults: Evaluation of a short form of the CES-D (Center for Epidemiologic Studies-Depression Scale). American Journal of Preventive Medicine,

10(2), 77-84.

Reprinted

with permission.

DBT for Recently Incarcerated Homeless Women 225

Bellg, A. J., Borrelli, B., Resnick, B., Hecht, J.,

Minicucci, D. S., Ory, M., ... Treatment Fidelity

Workgroup of the NIH Behavior Change Con- sortium, . (2004). Enhancing treatment fidelity in

health behavior change studies: Best practices and recommendations from the NIH Behavior Change Consortium. Health Psychology, 23, 443-451. doi:10.1037/0278-6133.23.5.443

Berzins, L. G., & Trestman, R. L. (2004). The devel-

opment and implementation of dialectical behavior therapy in forensic settings. International Journal of Forensic Mental Health, 3, 93-103. doi:10.1080/149

99013.2004.10471199

Binswanger, I. A., Nowels, C., Corsi, K. F., Long, J.,

Booth, R. E., Kutner, J., & Steiner, J. F. (2011).

“From the prison door right to the sidewalk, ev-

erything went downhill,” a qualitative study of the

health experiences of recently released inmates. Inter- national Journal of Law & Psychiatry, 34, 249-255. doi:10.1016/j.ijlp.2011.07.002

California Department of Corrections and Rehabilita- tion. (2014). 2013 Outcome Evaluation Report. Sac-

ramento, CA: Author. Retrieved from http://www. cder.ca.gov/Adult_Research_Branch/Research_docu- ments/Outcome_evaluation_Report_2013.pdf

Carliner, H., Delker, E., Fink, D. S., Keyes, K. M., &

Hasin, D. S. (2016). Racial discrimination, socioeco-

nomic position, and illicit drug use among US Blacks.

Social Psychiatry & Psychiatric Epidemiology, 51, 551-560. doi:10.1007/s00127-016-1174-y

Cobbina, J. E. (2010). Reintegration success and failure: Factors impacting reintegration among

incarcerated and formerly incarcerated women. Journal of Offender Rehabilitation, 49, 210-232.

doi:10.1080/10509671003666602 Fearn, N. E., Vaughn, M. G., Nelson, E. J., Salas-

Wright, C. P., DeLisi, M., & Qian, Z. (2016).

Trends and correlates of substance use disorders among probationers and parolees in the United

States 2002-2014. Drug & Alcohol Depen- dence, 167, 128-139. doi:10.1016/j.drugale- dep.2016.08.003

Freudenberg, N., Daniels, J., Crum, M., Perkins, T.,

& Richie, B. E. (2005). Coming home from jail: The social and health consequences of commu- nity reentry for women, male adolescents, and

their families and communities. American Journal of Public Health, 95, 1725-1736. doi:10.2105/

ajph.2004.056325

Galaif, E. R., Nyamathi, A. M., & Stein, J. A. (1999).

Psychosocial predictors of current drug use, drug problems, and physical drug dependence in homeless women. Addictive Behaviors, 24, 801-814.

Gratz, K. L., & Roemer, L. (2004). Multidimensional

assessment of emotional regulation and dysregu- lation: Development, factor structure, and initial

validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology & Behavioral

Assessment, 26, 41-54.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

226 APPENDIXA #® DBT for Recently Incarcerated Homeless Women

Gratz, K. L., & Roemer, L. (2008). Multidimensional

assessment of emotional regulation and dysregu- lation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale [Erratum]. Journal of Psychopathology & Behavioral Assessment, 30, 315. doi:10.1023/B:-

JOBA.0000007455.08539.94 Greenland, S. (1989). Modeling and variable selection

in epidemiologic analysis. American Journal of Pub- lic Health, 79, 340-349.

Institute of Behavioral Research. (2007). TCU drug

screen II. Fort Worth, TX: Texas Christian Uni-

versity. Retrieved from https://ibr.tcu.edu/forms/ tcu-drug-screen

Joe, G. W., Broome, K. M., Rowan-Szal, G. A., &

Simpson, D. D. (2002). Measuring patient attributes

and engagement in treatment. Journal of Substance Abuse Treatment, 22, 183-196.

Jolani, S., Frank, L. E., & van Buuren, S. (2014).

Dual imputation model for incomplete longitu- dinal data. British Journal of Mathematical & Statistical Psychology, 67, 197-212. doi:10.1111/ bmsp.12021

Lazarus, R., & Folkman, S. (1984). Stress, appraisal

and coping. New York, NY: Springer.

Leukefeld, C., Oser, C. B., Havens, J., Staton Tin-

dall, M., Mooney, J., Duvall, J. B., & Knudsen,

H. (2009). Drug abuse treatment beyond prison

walls. Addiction Science ¢& Clinical Practice, S,

24-30. Linehan, M. M. (1993). Cognitive-behavioral treat-

ment of borderline personality disorder. New York, NY: Guilford Press.

Linehan, M. M., Comtois, K. A., Murray, A. M.,

Brown, M. Z., Gallop, R. J., Heard, H. L., ...

Lindenboim, N. (2006). Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Archives of General Psychiatry, 63, 757-766. doi:10.1001/arch- psyc.63.7.757

McNeil, R., & Guirguis-Younger, M. (2012).

Illicit drug use as a challenge to the delivery of end-of-life care services to homeless persons: Perceptions of health and social services pro- fessionals. Palliative Medicine, 26, 350-359.

doi:10.1177/0269216311402713 Nee, C., & Farman, S. (2005). Female prisoners with

borderline personality disorder: Some promising treatment developments. Criminal Behavior and Mental Health, 15, 2-16. doi:10.1002/cbm.33

Nyamathi, A. (1989). Comprehensive health seeking and coping paradigm. Journal of Advanced Nursing, 14, 281-290.

Nyamathi, A., Leake, B., Albarran, C., Zhang, S., Hall,

E., Farabee, D., ... Faucette, M. (2011). Correlates

of depressive symptoms among homeless men on pa- role. Issues in Mental Health Nursing, 32, 501-511. doi:10.3109/01612840.2011.569111

Nyamathi, A., Leake, B., Longshore, D., & Gelberg,

L. (2001). Reliability of homeless women’s reports:

Concordance between hair assay and self report of cocaine use. Nursing Research, 50, 165-171.

Nyamathi, A. M., Srivastava, N., Salem, B. E., Wall,

S., Kwon, J., Ekstrand, M., ... Faucette, M. (2016). Female ex-offender perspectives on drug initiation, relapse, and desire to remain drug free. Journal of Forensic Nursing, 12, 81-90. doi:10.1097/ jfn.0000000000000110

Padgett, D. K., Stanhope, V., Henwood, B. F., &

Stefancic, A. (2011). Substance use outcomes among

homeless clients with serious mental illness: Com- paring housing first with treatment first programs. Community Mental Health Journal, 47, 227-232.

Rubin, D. B. (1987). Multiple imputation for nonre-

sponse in surveys. New York, NY: Wiley.

Salem, B. E., Nyamathi, A., Idemundia, F., Slaughter, R., & Ames, M. (2013). At a crossroads: Reentry chal-

lenges and healthcare needs among homeless female ex-offenders. Journal of Forensic Nursing, 9, 14-22.

Salem, B. E., Nyamathi, A., Keenan, C., Zhang, S.,

Marlow, E., Khalilifard, F., ... Marfisee, M. (2013).

Correlates of risky alcohol and methamphetamine use among currently homeless male parolees. Journal of Addictive Diseases, 32, 365-376. doi:10.1080/10 550887.2013.849973

Schlotfeldt, R. M. (1981). Nursing in the future. Nurs-

ing Outlook, 29, 295-301.

Shelton, D., Kesten, K., Zhang, W., & Trestman,

R. (2011). Impact of a dialectic behavior therapy- corrections modified (DBT-CM) upon behaviorally challenged incarcerated male adolescents. Journal of Child and Adolescent Psychiatric Nursing, 24, 105-113. doi:10.1111/}.1744-6171.2011.00275.x

Sherbourne, C. D., & Stewart, A. L. (1991). The MOS

social support survey. Social Science & Medicine, 32, 705-714.

Stewart, A. L., Hays, R. D., & Ware, J. E. Jr. (1988).

The MOS shortform general health survey. Reli- ability and validity in a patient population. Medical Care, 26, 724-735.

Stout, R. L., Wirtz, P. W., Carbonari, J. P., & Del

Boca, F. K. (1994). Ensuring balanced distribution

of prognostic factors in treatment outcome research. Journal of Studies on Alcohol. Supplement, 12, 70-75.

Tsai, J., Kasprow, W. J., & Rosenheck, R. A. (2013). Alcohol and drug use disorders among homeless veterans: Prevalence and association with sup- ported housing outcomes. Addictive Behaviors, 39,

455-460. doi:10.1016/j.addbeh.2013.02.002

Tucker, J. S., D’Amico, E. J., Wenzel, S. L., Goli-

nelli, D., Elliott, M. N., & Williamson, S. (2005).

A prospective study of risk and protective factors for substance use among impoverished women living in temporary shelter settings in Los Angeles County. Drug and Alcohol Dependence, 80, 35-43. doi:10.1016/j.drugalcdep. 2005.03.008

Reprinted

with permission.

APPENDIXA #8

Walters, G. D., White, T.W., & Denney, D. (1991).

The Lifestyle Criminality Screening Form. Pre- liminary data. Criminal Justice & Behavior, 18, 406-418. doi:10.1177/0093854891018004003

Wright, E. M., Van Voorhis, P., Bauman, A., &

Salisbury, E. J. (2008). Gender-responsive risk/needs assessment: Final report prepared for the Minnesota Department of Corrections. Cincinnati, OH: Univer-

sity of Cincinnati. Zeger, S. L., & Liang, K. Y. (1986). Longitudinal

data analysis for discrete and continuous outcomes. Biometrics, 42, 121-130.

Reprinted

with permission.

DBT for Recently Incarcerated Homeless Women 227

Zerger, S. (2002). Substance abuse treatment: What

works for homeless people? A review of the litera- ture. Nashville, TN: National Health Care for the Homeless Council.

Zhang, W., O’Brien, N., Forrest, J. I., Salters, K. A.,

Patterson, T. L., Montaner, J. S. G., ... Lima, V.

D. (2012). Validating a shortened depression scale (10 item CES-D) among HIV-positive people in

British Columbia, Canada. PLoS One, 7(7), e40793.

doi:10.1371/journal.pone.0040793

Generating and Assessing Evidence for Nursing Practice (11th ed.)

228 APPENDIXA ® DBT for Recently Incarcerated Homeless Women

Supplemental Digital Content 1

Assessed for Eligibility (N=176)

Excluded (n=46) Ineligible (n=34)

- Not Recently Arrested: (n=11) - Not Enrolled in RDT or

community program: (n=11) - Not Homeless: (n=13) - Not used drugs: (n=6) - Other reasons: (n=2)

Eligible but not enrolled (n =12)

Randomized (n=130)

—_~->--

Allocated to HP Group Allocated to DBT-CM

(n=65)

Received allocated intervention

(n=55)

(n=65) Received allocated intervention

(n=58)

| 6-Month Follow-Up

Lost to 6 Month follow-up

(n =6 out of 64)

Lost to 6 Month Follow-up (n =116) (n=7out of 65)

Death (n=1) not study related

Analysis (n =116)

Analyzed to Date Analyzed to Date

(n=58) (n=58)

Figure 1. CONSORT Flow Diagram.

APPENDIXA #

Supplemental Digital Content 2

# Dialectical Behavior Therapy Case

Management (DBT-CM) Program Description

The DBT-CM intervention was composed of six group sessions for up to 45 minutes over

the course of 6 months which was delivered by a Community Health Worker (CHW) RN team. Before and after the group sessions, the CHW/RN team, met with participants indi- vidually. The sessions were provided on an

as needed basis based on level of completion. The group content was focused on the fol- lowing: (a) alternate rebellion, (b) observing

urges, (c) adaptive denial, (d) burning bridges

to substance use, (e) building a life worth liv-

ing, and (f) avoiding/eliminating cues to use. Before or after each group session, individual one-on-one sessions with the CHW/RN were

held. The details of each group session are described below; subsequently thereafter, the one-on-one sessions will be described in

detail.

# Group Content

“Alternate rebellion” was composed of an

orientation topic of the day, establishing ground rules, getting to know participants,

along with handing out and going over

a resource packet. Likewise, information related to DBT, understanding the difference between a cloudy versus clear mind, identify-

ing common coping strategies people utilize

were discussed. The CHW and RN also went

over an alternate rebellion handout and

identified ways to use alternate rebellion in

your own personal life handout. Participants were asked to journal about a time they used

alternate rebellion.

Reprinted

with permission.

DBT for Recently Incarcerated Homeless Women 229

“Observing Urges” was composed of orienting participants to the topic of the

day and going over a “Mindless Exercise.” Afterwards, the CHW/RN team went over

observing urges, reminded participants to complete the diary card and concluded the session.

“Adaptive Denial” was composed of orienting participants to the topic of the day,

going over adaptive denial and basic distress tolerance skills. Subsequently, the CHW/RN

went over identifying common coping strate-

gies people use and cue controlled relaxation.

Additional exercises relating to distracting yourself by counting were reviewed. Further,

the CHW/RN team reminded each participant about completing the diary card. At the close

of the session, the CHW/RN team, wrapped up the session and provided a summary.

“Burning Bridges to Substance Use” was composed of orienting participants to the

topic of the day, reviewing ground rules, rediscovering your values, and going over

content related to burning bridges to sub- stance use. The CHW/RN team also went over goals of emotion regulation training and

the emotion regulation handout, titled myths about emotions. During this session, the CHW/RN team also went over the impor- tance of completing the diary card, provided a

conclusion and wrap up. “Building a Life Worth Living” was

composed of orienting participants to the topic of the day and reviewing ground rules. The CHW/RN team went over building a life worth living and what does building a life

worth living look like. In this session, partici-

pants were asked to creatively construct a col- lage based on images from magazines, words in articles and advertisements. Participants

glued the images and text on a large white

paper and they explained their collage. Similar to previous sessions, the CHW/RN

team reminded participants to complete the

diary card and concluded the session.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

230 APPENDIXA ® DBT for Recently Incarcerated Homeless Women

“Avoiding and Eliminating Cues to Use”

was composed of orienting participants to

the topic of the day, going over interper- sonal effectiveness, the concept of mindful

attention, and key interpersonal skills.

Likewise, the CHW/RN team went over

the guidelines for getting what you want, factors affecting interpersonal effective- ness and the interpersonal effectiveness/ self-management handout 1s: avoiding and eliminating cues to use. Similar to previ-

ous sessions, the CHW/RN team reminded

participants to complete the diary card, and

concluded the session. Diary Card. At the end of the session, par-

ticipants were reminded to fill out diary card; however, the diary card was not reviewed in

the group session due to the need to maintain

confidentiality. The diary card was a self- report tool which prompted participants to

rate their emotions, use of drugs and actions over the course of the last week. In addition,

the skills which were discussed in the group

sessions and reinforced during the one-on-one

sessions were assessed on a seven point scale (e.g., not thought about or used to didn’t try, used them, helped).

One-On-One Sessions. The CHW/RN team met with each participant six times indi- vidually within three months and continued to meet with them up to six months (as needed).

During the one-on-one sessions, the CHW/ RN team organized the session by going over

the diary card, organizing treatment targets, setting an agenda, going over a chain and

solution analysis. The CHW/RN team pro- vided targeted referrals utilizing a comprehen- sive array of health and social services (e.g.,

employment, education, reentry programs, substance use, vocational training, mental and

physical healthcare). Sessions were provided both in person and by phone depending upon the availability of the participant and the

level of access they had to transportation and a telephone. Each week, the CHW/RN team tracked participant’s weekly and reminded

them of their appointments. Program Evaluation. While the overall

program was evaluated at the six-month

follow up, at the end of each group session,

participants had the opportunity to evaluate the session based on organization, delivery, and responsiveness on a four point Likert

scale (e.g., excellent, good, fair, and poor).

APPENDIXA ®& DBT for Recently Incarcerated Homeless Women 231

Supplemental Digital Content 3

Substance Abstinence at Baseline and Six-Month Follow-up for the Complete Case Analysis

Occasion/substance HP DBT-CM

(n= 58) (n= 58)

n (%) eee ee

Baseline

Alcohol (no) 35 (60.3) 33 (56.9)

Marijuana (no) 25 (43.1) 29 (50.0)

Crack (no) 46 (79.3) 43 (74.1)

Cocaine (no) 49 (84.5) 46 (79.3)

Heroin (no) 53 (91.4) 56 (96.6)

Methamphetamine (no) 41 (70.7) 40 (69.0)

Any drug use (self-report) (no) 26 (44.8) 23 (39.7)

Any drug use? (no) 19 (32.8) 16 (27.6)

Drug or alcohol use (no) 17 (29.3) 15 (25.9)

Six-Month Follow-Up

Alcohol (no) 34 (58.6) 46 (79.3)

Marijuana (no) 35 (60.3) 43 (74.1)

Crack (no) 51 (87.9) 51 (87.9)

Cocaine (no) 54 (93.1) 55 (94.8)

Heroin (no) 55 (94.8) 58 (100.0)

Methamphetamine (no) 48 (82.8) 49 (84.5)

Any drug use (self-report) (no) 35 (60.3) 42 (72.4)

Any drug use? (no) 28 (48.3) 38 (65.5)

Drug or alcohol (no) 26 (44.8) 36 (62.1)

*Based on self-report and urinalysis.

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

INFANT FEEDING BELIEFS AND

Day-To-DaAY FEEDING PRACTICES

orf NICU Nurses Roberta Cricco-Lizza

Breastfeeding is the recommended feeding method for infants (American Academy of

Pediatrics, 2012; Association of Women’s

Health, Obstetrics and Neonatal Nurses,

2015). The unique qualities of breastfeeding/

breast milk feeding are especially import-

ant for vulnerable infants in the Neonatal Intensive Care Unit (NICU) (American

Academy of Pediatrics; Ip et al., 2007). Breast

milk provides particular protection against

infections (Ip et al. 2007), and necrotizing

enterocolitis (Sullivan et al., 2010) and has

also been linked to enhanced neurodevelop- mental outcomes for these high risk infants (Vohr et al., 2006). In addition, Lucas (2005)

has indicated that breast milk feeding has long term consequences that can positively

influence cardiovascular, bone, and cognitive function in adulthood. Breastfeeding can also reduce later risk of obesity and diabetes (Ip et al., 2007).

Despite these health outcomes, breast- feeding/breast milk feeding rates are low for

NICU infants in the United States (Lee &

Gould, 2009; Merewood, Brooks, Bauchner,

MacAuley, & Mehta, 2006). Complex

maternal, neonatal, staff, and hospital factors

influence NICU breastfeeding rates (Lessen &

Crivelli-Kovach, 2007; Renfrew et al., 2009).

NICU nurses can play significant roles in

promoting and supporting breastfeeding, despite the unique challenges facing high risk babies and mothers (Callen & Pinelli, 2005).

Indeed, nursing leaders have played critical

roles in the promotion of breastfeeding in United States’ NICUs (Meier, Patel, Bigger,

Rossman, & Engstrom, 2013; Spatz, 2010).

Wheeler, Chapman, Johnson, and Langdon (2000) found that nurses positively affected breastfeeding initiation in the NICU by supporting mothers with breastmilk expres- sion and early contact with the breast.

Breastfeeding duration has been associated with assistance from NICU nurses (Lessen

& Crivelli-Kovach, 2007), although moth-

ers have also reported limited support for

breastfeeding by NICU nurses (Cricco-Lizza,

2006). Breastfeeding beliefs, knowledge, and attitudes have been related to breastfeeding support from maternal child health nurses (Bernaix, 2000; Ouyang, Xu, & Zhang, 2012;

Spear, 2004). Renfrew et al. (2009) have

called for additional research about NICU professionals’ views about breastfeeding and recommended that studies should investigate their specific beliefs and attitudes as a basis for staff training.

Breastfeeding beliefs do not occur in a vacuum, and a broad scale approach is important to explore the context of infant feeding in the NICU. The current report is

part of a larger study that examined multiple contexts for infant feeding for nurses within one NICU. Previous publications from this

large investigation have revealed individual, familial, and institutional contexts of infant

232 Reprinted with permission from Cricco-Lizza, R. (2016). Infant feeding beliefs and day-to-day feeding practices of NICU nurses. Journal of Pediatric Nursing, 31(2), e91-e98.

APPENDIXB @

feeding for these same NICU nurses. These nurses described formula feeding norms during

their early years and acknowledged inadequate exposure to breastfeeding during their nursing

school education (Cricco-Lizza, 2009a). An

additional report delineated the infrastruc-

tural and human resource development efforts for breastfeeding promotion in this NICU and found that differences in breastfeeding knowledge and experience among the nurses, formula company marketing, and uneven support from other health professionals served as sources of conflicting breastfeeding mes- sages (Cricco-Lizza, 2009b). An examination

of NICU values demonstrated that nurses confronted uncertainty through firm control

of care, reliance on technology, and strict time

efficiency, but that these values also posed challenges to nursing efforts to promote breast- feeding (Cricco-Lizza, 2011). Furthermore, this

demanding work exacted high levels of emo- tional labor from the NICU nurses which was largely unrecognized (Cricco-Lizza, 2014). It is within these contexts that this current report should be considered.

Exploring how breastfeeding is viewed within the context of the actual bedside feed- ing practices in the NICU can lead to a more

nuanced understanding of the NICU feeding culture. The purpose of this study is to exam-

ine the infant feeding beliefs and day-to-day

feeding practices of NICU nurses.

= Method

An ethnographic approach can capture

ideational and material aspects of a culture

(Fetterman, 2010). This qualitative design used

interviewing and participant observation and allowed for personal interactions embedded within the NICU culture. Over this 14 month

investigation, general informants were selected to provide a broad overview of beliefs and practices in the unit. From this group, key

informants were followed more extensively to

obtain an in-depth view. Both key and general

informants were purposively selected for a

Reprinted

with permission.

Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses 233

maximal variety of infant feeding beliefs and

practices (Patton, 2015). These informants

were observed and formally or informally

interviewed to obtain rich details about infant

feeding in the NICU. Participant observation

facilitated the gathering of information about their actual infant feeding practices while

informal and formal interviews allowed for

exploration of their specific beliefs. This study

was conducted in a level-IV NICU in a free standing, children’s hospital in the northeast-

ern United States. The nursing and medical directors granted permission for data collection

in this NICU, and the nurses were informed

about the study through the intranet, staff meetings, and face-to-face interactions in the

NICU. University- and hospital-based human subjects committees allowed ethical approval

for this investigation with the stipulation that

nurses provide written informed-consent for the formal tape-recorded interviews.

SAMPLE

There were 250 nurses employed in this NICU and they were predominantly White women.

In this study, 114 general informants were selected at the bedside based on their varied interactions during infant feeding and nursing

care. All but one were women, 96 were

White, 9 African American, 8 Asian, and 1

Hispanic. Approximately 30% of the general informants had taken a 16-hour, hospital-

developed breastfeeding course. More detailed demographic information

was obtained about the key informants. There

were 18 key informants who were selected

from the group of 114 general informants. They were identified during participant

observation as being knowledgeable and articulate about varied infant feeding beliefs

and practices and agreed to in-depth fol- low-up. Their ages ranged from 22 to 51 with

an average age of 33 years. Among this group

of key informants, 17 were women, 16 were

white and 2 were African American. Eleven

key informants were childless and 7 were

parents. Two had nursing diplomas, 1 had an

Generating and Assessing Evidence for Nursing Practice (11th ed.)

234 APPENDIXB # Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses

associate’s degree, 14 had bachelor’s degrees

and 1 had a master’s degree in nursing. They were fairly well divided amongst the hospi-

tal’s four ascending clinical skill levels from

novice nurses to clinical experts. About 50% of these key informants had taken the hospital

breastfeeding course and almost 25% were on

the NICU breastfeeding committee.

DATA COLLECTION

Participant Observation. A key part of

ethnography is using participant observa- tion to explore everyday life (Pink, 2012).

Fieldwork in the NICU was conducted during

one or two hour sessions on varying days,

times, and shifts over a 14 month period. The sole investigator introduced herself as a nurse researcher and asked the nurses to share their

perspectives about infant feeding and nursing

care in the NICU. The nurses were observed during their interactions with babies, families,

nurses, and other staff throughout the varied

activities in the unit. Included in these obser- vations were recurrent infant feedings, routine

nursing care, shift reports, committee meet-

ings, and the nurse-run breastfeeding support meetings for parents. The nurse researcher role varied from observation to informal

interviewing during the 128 participant obser-

vation sessions in this study. These informal

interviews were open ended and related to

the immediate circumstances of NICU care. The 114 general informants described their

beliefs and their day-to-day work in the unit. They were observed/informally interviewed an average of 3.5 times each with a range of 1 to 24 throughout the study. These data were

documented in detailed field notes immedi-

ately after each session and pseudonyms were used to protect confidentiality.

Interviews. In-depth, responsive interview-

ing was utilized to gather data about the infant feeding culture in the NICU (Rubin &

Rubin, 2012). There was a formal, 1-hour,

tape-recorded interview with each of the 18 key informants. These interviews were

conducted in a private room near the NICU

at specific times chosen by these nurses.

They were assured of the confidentiality of their responses to open-ended questions

about breastfeeding, formula feeding, and

the nature of their nursing care. The nurses were asked to describe their work days

and their specific responsibilities for infant feeding. In addition, the nurses were also

asked for further explanation about issues that might have arisen during participant observation sessions. Including this formal interview, the key informants were observed/ informally interviewed a total of 3-43 times each with an average of 13.1 interactions per informant. This prolonged contact facilitated a deeper exploration of infant feeding beliefs and practices in this NICU. The interviews

were labeled with pseudonyms, and the interviews were transcribed verbatim. These

transcripts included the words and behaviors

of the nurses during the interviews. They

were checked line-by-line for accuracy and compared directly against the recordings.

DATA MANAGEMENT, ANALYSIS, AND VERIFICATION

The field notes from observations, the tran-

scripts from interviews, and regularly com-

posed analytic memos were entered into the

QSR NUD*IST computer software program

for data management and analysis (Qualitative

Solutions Pty Ltd, 1997). Data analyses were

conducted alongside data collection in a spiral fashion. Questions raised during analyses

were then explored in greater depth in the next interview or observation. The data were

reviewed iteratively; codes were inductively derived for meaning, refined and reorganized

into categories; and then compared, contrasted and analyzed for patterns (Miles, Huberman

& Saldana, 2014). The data were robustly

saturated after repeated observations and

interviews. The findings were verified through prolonged engagement, member checking, and triangulation of participant observation and

interviews (Creswell, 2013). In addition, peer

APPENDIXB @

review at the university allowed for oral and written critique of all phases of the research, including findings.

FINDINGS

The findings of this study reflect the infant feeding beliefs and day-to-day practices of

nurses in a well staffed, high acuity NICU. These findings will be presented thematically:

Theme 1. The nurses identified health benefits of breastfeeding, but spoke in greater detail

and with more emotion about day-to-day challenges of breastfeeding in the NICU.

Theme 2. Formula feeding evoked less emo-

tion, and most nurses viewed it as safe

and convenient.

Theme 3. Despite infant feeding challenges in

the NICU, nurses who had breastfeed-

ing continuing education and/or some

positive experiences with breastfeeding:

identified evidence-based breastfeed-

ing benefits for mothers and babies; emphasized the health-based differ- ences between breast milk and formula;

and were more committed to working

through difficulties with breastfeeding.

THEME 1: THE NURSES IDENTIFIED HEALTH BENEFITS OF BREASTFEEDING, BUT SPOKE IN GREATER DETAIL AND EMOTION ABOUT DAY-TO-DAY CHALLENGES OF BREASTFEEDING IN THE NICU

This theme will be subdivided into three

subsections to demonstrate the nurses’ beliefs

about the health benefits of breastfeeding, their beliefs about the challenges of breast-

feeding in the NICU and their identification of the day-to-day practice challenges of breast-

feeding in the NICU.

Beliefs About Health Benefits of Breastfeeding. The NICU nurses described

several health advantages of breastfeeding.

These included: intellectual, nutritional,

Reprinted

with permission.

Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses 235

digestive, anti-infective, and anti-allergenic

benefits for babies, along with bonding and empowerment for mothers. For example, one key informant stated,

Well the list goes on and on about the benefits

for breastfeeding. You know as far as all the

medical benefits that have been noted and

then the emotional and psychological benefits

as well for the mother. So there are lots of

benefits for the mother and lots of benefits for the baby.

In a similar fashion a general informant

said, “I think it obviously is a natural way to feed a baby. And it provides the baby with all the nutrients and the immunity protection

it needs to live. It also promotes bonding with the mom.” There was variation among

the staff as to the strength of their beliefs

about these advantages, but consistently the general and key informants agreed that there

were many hurdles for breastfeeding in the

NICU.

Beliefs About Challenges of Breastfeeding

in the NICU. The NICU nurses spoke in great detail about their beliefs about dif- ficulties with breastfeeding in the unit. A matrix search of their breastfeeding beliefs and expressed emotions revealed the pre- dominance of anxiety, embarrassment, and frustration in the nurses. The general and key informants talked with strong feelings

about their concerns for vulnerable babies,

anxious mothers, and discomfort of staff,

along with the lack of privacy in the NICU

environment.

Many informants described breastfeed- ing difficulties that they associated with the

high acuity of illness of babies, maternal/ infant separation, and stressed mothers. One key informant expressed a common

belief when she said that this NICU

had:

very, very sick infants who are requiring resus-

citation, who are not eating for a long time and

mothers are pumping for a long time ... and

basically for parents who want to breastfeed, |

would say ... it is very difficult.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

236 APPENDIXB ® Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses

Many nurses focused on the “emotional

disruption” for mothers of NICU babies. One

stated,

If mom is upset and isn’t able to get her milk

supply started, or it hasn’t gotten started early

on, or is just upset by the whole situation and

she isn’t able to sit there with the baby, to put

the baby to breast, to have that kind of patience

to really be able to bond then yes, absolutely, it

is an absolute mess!

Some of the nurses also talked about

the challenges of working with adolescent

mothers and felt that they were not inter- ested in breastfeeding. One key informant explained that the teens were often “not comfortable with their bodies. They don’t

understand the importance of breastfeed-

ing.” She said that it was not uncommon

to hear these mothers say, “EWWW that’s

disgusting! I’d never do that.” Another key

informant stated a popular belief when she said, “Teenagers often think of their breasts as sexual organs and not a nutritional

source for babies.”

General and key informants also believed that there were environmental constraints

and a lack of privacy for breastfeeding in the NICU. One key informant stated that breast-

feeding was “difficult in our environment.” Another one described the NICU setting in this way:

It’s a totally miserable, it’s just, it’s not a com-

fortable place to breastfeed. You know what I

mean; it’s very open; we’re walking around. We

have these screens that fall down and ... if the

moms aren’t relaxed, it’s not going to work.

There was also evidence that reflected

discomfort with breastfeeding on the part of some NICU staff members. A key infor-

mant reflected a common belief when she

said,

There are people who are uncomfortable with

women breastfeeding and occasionally some

women who are TOO comfortable with it, in

my opinion... and I... am not always com-

fortable seeing that... I think there should be

a healthy balance of modesty attached to the breastfeeding.

Another nurse was clearly embarrassed when she described a mother who continued

to pump at the bedside while the doctors made rounds. She said,

Sometimes we have to screen them in. They

come from all cultures. Some of them, they

throw a blanket. Others— we had a mom who

just pumped and she [was] talking to [her]

doctors and they [didn’t know] what to do with

their eyes!

Day-to-Day Practice Challenges of

Breastfeeding in the NICU. Many nurses

emotionally described the multiple responsi- bilities involved in the care of breastfeeding mothers. These informants spoke about the effort required for breastfeeding education, pumping, breast milk management, feeding of breast milk by bottle, and assistance getting babies to the breast. One nurse stated,

Well if I had the time, then in a perfect world,

I would sit down and I would go over all the

advantages of breastfeeding as opposed to for-

mula feeding... I think you need like 45 minutes

to an hour to sit down and to talk to the mother

about it. Because there is so much... informa-

tion about it... like what it contains and how it helps the baby.

For both breast milk feeding and actual breastfeeding, the general and key informants described numerous responsibilities in their

daily practice. In regard to a mother who was feeding breast milk in a bottle, one key

informant said that the NICU nurses “provide the mom with a breast pump and kit and make sure she was equipped to pump breast milk.”

Another key informant described the unit prac- tice for feeding a baby pumped milk. She said,

You have to do a two RN check if it’s breast

milk from a bottle ... warming the milk

obviously because it’s been in the refrigerator,

making sure that it’s not expired, making sure

it’s defrosted, not past the expiration date for

defrosting, and then doing the actual feeding.

For mothers who were getting their babies to the breast, a key informant

described the usual NICU nursing practice in this fashion:

APPENDIXB &

You have to talk to them [mothers] about

what they want to do... Make sure that the

mom is comfortable and is available... You

have to take more time to explain how to use

the test weight scale and a lot of times you

have to like pause your medications... because in order for mom to get a comfortable feeding

position you are occluding the IV temporar-

ily and... that can cause issues... and then follow up with the weights before and after,

educating mom also on how to use the test weight scale.

Other nurses talked about emotionally

demanding experiences helping mothers get their babies to the breast. Some confided that they did not feel prepared to offer this assistance and it made them feel uncom-

fortable. Others felt frustrated with the

extra effort. One nurse said, “It took me

a good hour and a half to work with that

mom one-on-one. To give a bottle takes 15 minutes.” In a similar fashion another key

informant said,

I know that sometimes a baby needs to eat to

grow and maybe get out of here and mom may

be a little bit stressed, so I may not want to do

pre and post weights. I might just want to feed

him the breast milk in the bottle and think that

when she’s home in a more comfortable setting

that she’ll probably have better luck at nursing. I have an hour and I’m looking at a mom trying

for 30 minutes and then the baby just wants to

eat and then we have to n.g. him because he’s

used all his energy.

During an observation, a general informant

said that she was frustrated after unsuccessfully

trying to help a mother to breastfeed. She felt that she had invested so much effort to no avail. She believed that it was easier to bottle feed.

THEME 2: FORMULA FEEDING EVOKED LESS EMOTION AND MOST NURSES VIEWED IT AS SAFE AND CONVENIENT IN DAILY

PRACTICE

The general and key informants acknowl- edged that formula was “a good alternative”

or “a second option” for mothers in the

Reprinted with permission.

Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses 237

NICU. The NICU nurses were comfortable

with formula feeding. One nurse represented many when she said,

We’re fortunate enough to have that alterna-

tive. You know it’s obviously not bad for our

babies or we wouldn’t be giving it to them.

And they are obviously trying to make it as

close to breast milk as possible and as soft to

the belly.

Another key informant expressed a common sentiment, “Bottle feeding infants do fine.” The nurses valued technology in their daily work and this carried over into

infant feeding. Another informant stated,

“Sometimes I think in this day and age with all the technology for formula creation, that there’s nothing wrong with giving formula.”

Nurses also noted the ease of formula

feeding during daily care. When asked

about their everyday practices for formula

feeding, one nurse summed up the common sentiment of the general and key informants in this way, “Formula-pretty much you

crack the seal and stick a nipple on it, and

you are good to go-so in that respect, it’s easier.” In some cases, nurses felt that for-

mula feeding was less risky than breastfeed- ing. One key informant said that formula “definitely has less human risk of carrying any kind of disease.” Similarly, another

NICU nurse said,

We have to do a two RN check [for breast milk]

and that’s okay, but isn’t it easier to get that

[formula] bottle? No one asks for a two RN

check for formula. You know what I mean?...

It’s not someone’s secretions [from] their body

so we don’t really check as much. You know, I

think the bottle is easier.

A few other NICU nurses offered the same viewpoint. One of them said, “We really have

grown, but there is still a sense that breast milk is like yucky stuff, you know, when

you’re dealing with somebody’s body fluid, and that formula somehow is cleaner.” In

a unit where nurses were markedly vigilant

about infection control and safety, there existed some distrust about exactly what was

Generating and Assessing Evidence for Nursing Practice (11th ed.)

238 APPENDIXB ® _ Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses

in mother’s milk. There were some nurses

who were concerned with medications in

breast milk and they verbalized unease about the safety of the infant. One key informant said, “Where there is a mother taking certain

medications and there is a fear that it will

cross over then and harm the baby then absolutely no way, then absolutely formula

first.” Another informant also said that she

knows that there was a readily available

reference textbook in the unit to check for

compatibility of varied medications with

breastfeeding, but that she did not believe in it. She said, “What the mother takes, the

baby gets” and she did not think that it was

safe to use breast milk when the mother was

taking medications.

THEME 3: DESPITE INFANT FEEDING CHALLENGES IN THE NICU, NURSES WHO HAD BREASTFEEDING CONTINUING EDUCATION AND/OR SOME POSITIVE EXPERIENCES WITH BREASTFEEDING: IDENTIFIED EVIDENCE-BASED BREASTFEEDING BENEFITS FOR MOTHERS AND BABIES; EMPHASIZED THE HEALTH-BASED DIFFERENCES BETWEEN BREASTFEEDING AND FORMULA; AND

WERE COMMITTED TO WORKING THROUGH DIFFICULTIES WITH BREASTFEEDING

The general and key informants revealed

that this children’s hospital required all new NICU nurse employees to take a 16-hour

breastfeeding course. For previously hired

NICU nurses, this course was optional. The

informants identified that approximately 45

out of the 250 NICU nurses had completed

the course and they, along with lactation

consultants, served as breastfeeding resources in this NICU.

As reflected in the first part of this third

theme, nurses who had continuing education

about breastfeeding and/or some positive

personal/familial breastfeeding experiences

identified evidence-based breastfeeding bene-

fits for mothers and babies. These nurses were the most enthusiastic about breastfeeding during their day-to-day practices in the unit.

For example, one general informant who had

taken the breastfeeding course was observed during her care for an unstable premature

baby. When the adolescent mother came to

visit, this nurse took the time to listen to this

mother’s concerns and spoke with her about

the evidence-based benefits of breastfeeding. Later, the nurse was observed encourag- ing and praising the mother for her initial

attempts at breast pumping. Another key informant identified multi-

ple advantages of breastfeeding and further explained how she supported breastfeeding

in her daily practice in the NICU. She cited the importance of the breastfeeding course and her positive personal experiences for her

beliefs and intended to breastfeed her own children in the future. She stated, “When I

have a kid, I wouldn’t do it [formula feed]

because I took the breastfeeding course or just

mainly growing up-like my parents breast-

fed me... To me the best thing ... is breast

milk.” Other nurses talked in animated terms

about the evidence-based benefits of breast- feeding for NICU babies. One said, “I think

it’s incredible, specifically for our population

here. They are so immuno-compromised

that they can use ANYTHING to help them

get through this whole course here in the hospital.” She identified the unique qualities

of breast milk, but noted that not all NICU

nurses understood this. She said,

You know immunological properties of the

breast milk are really important ... Our kids can hardly eat and so when they do, if we can give

them something easily digestible, that’s made

specifically for them, I mean to me, it’s just

probably the most important thing that we’re

able to do for our babies, but we just don’t all recognize that yet.

Secondly, those nurses who had com- pleted the breastfeeding course and/or had positive experiences with breastfeeding

APPENDIX B a

emphasized the health-based differences between formula and breastfeeding. In

particular, they not only acknowledged the benefits to breastfeeding, but clearly identi- fied specific differences between breastfeed- ing and formula. One stated, “The benefits of breast milk just so far outweigh what formula is.” Another believed that formula

“definitely was not nutritionally as good [as] the baby doesn’t get the antibodies ... white

blood cells and stuff that they would get from the mom.”

Finally, the nurses who had completed the breastfeeding continuing education and/

or had affirming personal experiences were more committed to working through diffi-

culties with breastfeeding in the NICU. One

key informant said, “But I also understand the benefits [of breastfeeding] so it kind of

makes it like we want to do this. We want

to promote this as much as possible. It’s

definitely a lot more work.” These nurses were more attuned to checking with the mother about her milk production during the time before oral feedings were started. One said,

I mean if the baby’s predominantly getting

breast milk, which you want the baby to get

because it is SO good for the baby, then you have to make sure that it’s actually coming in.

So kind of neglecting that, is neglecting the

baby.

These nurses accepted that while breast milk feeding and breastfeeding were time

intensive, they believed that this time was a

good investment for their efforts. One key

informant acknowledged the many daily demands of NICU nursing, but was commit- ted to breastfeeding promotion because “it’s

something that’s worth it.” Support for this third theme was further

strengthened by parallel assessment of the nurses who had no continuing education

about breastfeeding and/or no positive personal experiences. These nurses tended to view care of breastfeeding mothers in this way: “It was just awkward for me because

Reprinted

with permission.

Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses 239

I hadn’t really done it as a nurse or as a

parent... I’m still not incredibly comfortable

with it because I don’t feel very proficient.” These same nurses did not indicate any

interest in learning these skills and were not inclined to take the breastfeeding course.

Participant observation revealed that these nurses often overlooked opportunities for the promotion of breastfeeding and skin-to- skin care in the NICU. One general infor-

mant said that some nurses would give the

mothers a defrosted bottle of milk instead of encouraging the initiation of breastfeeding. This was witnessed at the bedside during

several participant observation sessions. In

addition, the change of shift report fre- quently demonstrated that communication

about pumping, transition to the breast, and breastmilk availability was inconsistent.

In some cases, the nurses would substitute

formula rather than call the mother to check with her. One general informant said that breastfeeding promotion was “not on the

radar screen” of all of the NICU nurses.

The nurses who did not take the breast- feeding course generally did not acknowl-

edge differences between breastfeeding and

formula feeding. For example, one of these nurses said that she formula fed her own

babies and “There was no difference in their health.” These nurses generally relied on their own past experiences rather than the

science of lactation.

& Discussion

The Association of Women’s Health,

Obstetrics and Neonatal Nurses (2015) rec-

ommends that nurses should encourage and support breast milk feeding/breastfeeding for vulnerable and premature infants. This ethno- graphic study explored NICU nurses’ infant

feeding beliefs and the day-to-day feeding

practices at the bedside. Most of the nurses

identified health advantages of breastfeeding

Generating and Assessing Evidence for Nursing Practice (11th ed.)

240 APPENDIXB # Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses

for mothers and babies, but the strength of

these beliefs varied among the staff. Like Bernaix (2000), this study found that nurses’

experiences and education influenced their

beliefs about breastfeeding. Similar to Spear

(2004), some of the NICU nurses had limited

understanding of the differences between breast milk and formula. In Spear’s study, NICU nurses had lower mean breastfeeding knowledge and attitude scores than other maternal child health nurses. Spear asked

one open ended question about breastfeeding

beliefs and found that the nurses generally supported breastfeeding. The strengthsof this current study is that it explored breastfeeding beliefs in depth. It contributes uniquely to the literature by contextualizing these beliefs within the day-to-day feeding practices at

the bedside. The NICU nurses in the cur- rent study believed that breast milk feeding and breastfeeding were more difficult than formula feeding during their daily work on

the unit. This study identified and detailed

their perceived challenges related to acutely ill infants, anxious parents, maternal/baby

separation, privacy concerns, staff discomfort,

and environmental and daily practice con-

straints. The nurses voiced feelings of anxiety, embarrassment, and frustration when dealing

with these challenges to breast feeding promo-

tion. In contrast, formula feeding evoked less emotion and was viewed as safe, efficient, and

convenient in day-to-day feeding. These beliefs raise questions about nurses’

potential impact on NICU mothers and

babies. Mothers have reported that NICU

breastfeeding support varied among individ-

ual nurses and felt that these nurses’ conflict- ing advice continued to negatively affect them and their sense of motherhood after discharge (Niela-Vilen, Axelin, Melender, Salantera,

2014). In contrast, Miracle, Meier, and

Bennett (2004) reported that NICU nurses’

attitudes and beliefs positively influenced

infant feeding decisions of NICU mothers.

These mothers reported that the NICU staff had clearly emphasized the differences

between breast milk and formula and the mothers identified that these differences were the most important factor in their decision

to provide breast milk for their infants. The varying beliefs of the nurses in this current study could serve as a source of inconsistency

in breastfeeding promotion for NICU families. While the nurses in the present study

generally referred to breastfeeding as ben- eficial for high-risk infants, not all of them recognized that there were evidence-based

differences between formula and breast milk. Those who had positive past experi-

ences with breastfeeding and/or had taken

the hospital-sponsored breastfeeding course

recognized the differences and believed that

it was worth the extra effort to promote

breastfeeding. Those nurses without positive

breastfeeding experiences and education often resorted to the convenience of formula

feeding. Taylor, Gribble, Sheehan, Smith,

and Dykes (2011) reported that NICU

nurses also talked about the hard work of breastfeeding promotion and used formula

for convenience; however the nurses in that

study experienced staff shortages and high workloads. The nurses in the current study

had generous staffing and material resources

to support breastfeeding, but they also had a very high acuity level and the cultural

milieu might have been different (Cricco- Lizza, 2009b). In this Level-IV NICU the

nurses valued tight control of actions,

reliance on technology, and maximal efficiency in use of time, and breastfeeding promotion had an uneven fit with these cultural values (Cricco-Lizza, 2011). Similar

to Niela-Vilen et al., (2014), the nurses in

the current study emphasized the techni-

cal aspects of breast milk feeding but the emotional aspects of breastfeeding were not often prioritized. Modes of infant feeding were emotionally laden for the nurses in

this acute work environment, which already

demanded high levels of emotional labor

from them (Cricco-Lizza, 2014). As a result,

there were varying levels of commitment

APPENDIXB #

to breastfeeding during daily care prac- tices which led to missed opportunities for breastfeeding support at the bedside.

Bernaix, Schmidt, Arrizola, Iovinelli,

and Medina-Poelinez (2008) found that

NICU nurses’ lactation knowledge, attitudes and beliefs improved after an educational intervention. Not all of the NICU nurses in

this current study had completed the breast-

feeding course offered by this hospital, and this was reflected in the different ways that they talked about and supported breast- feeding and formula feeding at the bedside. Mandatory training using standards from

the Baby Friendly Hospital Initiative (BFHI) has led to increased breastfeeding rates and positive changes in staff attitudes, knowl-

edge, and confidence in breastfeeding sup- port (Ingram, Johnson, & Condon, 2011).

However, the BFHI ten steps were not

specifically written for NICUs (World Health Organization/United Nations Children’s Fund, 1992). The current study demon-

strates the need for further research to deter-

mine the best practice guidelines in NICU settings. The development of specialized staff

education should be geared to overcoming

the unique hurdles in everyday practice. This

education should not be optional for NICU nurses.

# Implications for Nursing

NICUs have exceptional challenges in the promotion of breastfeeding and this

current study offered insight into the nurses’ perspectives. Their concerns are

important to address. Meier et al. (2013)

have called for a move to evidence-based care for breastfeeding promotion in the NICU. They emphasized the need for more rationality and less emotion. Establishing

clear NICU standards will help to make this shift, but this current study demon- strates that emotional responses are still a

Reprinted

with permission.

Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses 241

considerable barrier to this process. These

findings clearly call out for educational pro-

grams that directly address these emotions. Matthew-Maich, Ploeg, Jack, and Dobbins

(2012) found that front line leaders who

focused on individual breastfeeding atti-

tudes and beliefs facilitated the staff uptake of breastfeeding best practice guidelines.

Renfrew et al. (2009) recommended the

use of a psychological/behavioral model to guide training programs for implementing evidence-based practice for breastfeeding promotion. By consensus, Michi et al.

(2005) identified 12 behavioral domains

that are important for change processes. These domains could be useful in a broad-

based change process for NICU breastfeed- ing training. They would allow for attention

to personal beliefs and attitudes. Critical reflection about these factors would help

the nurses explore their emotions related to

breastfeeding and could be used to address

the challenges to evidence-based practice

that were identified in the current study.

# Conclusion

Novel strategies are needed to overcome

challenges to breastfeeding promotion in

the NICU. Vulnerable NICU babies and mothers need their nurses to be clinically

prepared to support, promote, and protect breastfeeding at the bedside. The nurses in this study identified that they felt anxious, frustrated, or embarrassed with the challenges

of breastfeeding in the NICU. This research

demonstrates that both the emotional and

educational needs of the NICU staff nurses must be addressed before they can feel com- petent and comfortable with the promotion and support of breastfeeding. A limitation of this study is that it was conducted on a high intensity NICU that was well stafted. More exploration is needed in lower intensity and

less well staffed units.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

242 APPENDIXB ® _ Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses

ACKNOWLEDGMENTS

The author acknowledges the generosity of the NICU nurse participants and thanks Drs. Eli Cricco-Lizza, Janet Deatrick, Sandra

Founds, Diane Spatz, and Frances Ward for

support during this study.

Funding: The author discloses receipt of

the following sources of financial support for the research: National

Institute of Nursing Research/National

Institutes of Health Grant to the University of Pennsylvania School

of Nursing, Research on Vulnerable

Women, Children and Families

(T32-NR007100) and the Xi Chapter of Sigma Theta Tau International

Honor Society of Nursing.

Corresponding Author: Roberta Cricco-Lizza,

20 Woodshire Terrace, Towaco, New

Jersey 07082 USA, rcricco@nursing.

upenn.edu.

Publisher’s Disclaimer: This is a PDF file of an unedited manuscript that has been

accepted for publication. As a service to

our customers we are providing this early version of the manuscript. The manu-

script will undergo copyediting, typeset-

ting, and review of the resulting proof before it is published in its final citable form. Please note that during the pro-

duction process errors may be discovered which could affect the content, and all

legal disclaimers that apply to the journal pertain.

Declaration of Conflicting Interests:

The author declares no conflicts of interest

with respect to the authorship and/or publication of this article.

REFERENCES American Academy of Pediatrics Section on Breast-

feeding. (2012). Breastfeeding and the use of human

milk. Pediatrics, 129(3), e827-e841. doi:10.1542/

peds.2011-3552 [PubMed: 22371471]. Association of Women’s Health, Obstetric, and Neona-

tal Nurses. (2015). AWHONN position statement:

Breastfeeding. Journal of Obstetric, Gynecologic and Neonatal Nursing, 44, 145-150.

Bernaix, L. W. (2000). Nurses’ attitudes, subjective norms, and behavioral intentions toward support of breastfeeding mothers. Journal of Human Lactation, 16, 201-209. doi:10.1177/089033440001600304 [PubMed: 11153153].

Bernaix, L. W., Schmidt, C. A., Arrizola, M., lovinelli,

D., & Medina-Poelinez, C. (2008). Success of a

lactation education program on NICU nurses’ knowledge and attitudes. Journal of Obstetric, Gynecologic and Neonatal Nursing, 37, 436-445. doi:10.1111/).1552-6909.2008.00261.x.

Callen, J., & Pinelli, J. (2005). A review of the literature

examining the benefits and challenges, incidence and duration, and barriers to breastfeeding in preterm infants. Advances in Neonatal Care, 5, 72-88.

doi:10.1016/j.adne.2004.12.003 [PubMed: 15806448]. Creswell, J. W. (2013). Qualitative inquiry and

research design: Choosing among five traditions. Los Angeles, CA: Sage.

Cricco-Lizza, R. (2006). Black non hispanic mothers’

perceptions about the promotion of infant feed- ing methods by nurses and physicians. Journal of Obstetric, Gynecologic and Neonatal Nursing, 35, 173-180. doi:10.1111/).1552-6909.2006.00033.x.

Cricco-Lizza, R. (2009a). Formative infant experiences

and education of NICU nurses. MCN: The American Journal of Maternal Child Nursing, 34, 236-242. doi:10.1097/01.NMC.0000357916.33476.a3 [PubMed: 19587568].

Cricco-Lizza, R. (2009b). Rooting for the breast:

Breastfeeding promotion in the NICU. MCN: The American Journal of Maternal Child Nursing, 34, 356-364. doi:10.1097/01.NMC.0000363684.43186. fe [PubMed: 19901697].

Cricco-Lizza, R. (2011). Everyday practice values of NICU nurses and their reflection on breastfeeding promotion. Qualitative Health Research, 21, 399- 409. doi:10.1177/1049732310379239 [PubMed: 20682967].

Cricco-Lizza, R. (2014). The need to nurse the

nurse; Emotional labor in neonatal intensive

care. Qualitative Health Research, 24, 615-628. doi:10.1177/1049732314528810 [PubMed: 24675967).

Fetterman, D. M. (2010). Ethnography: Step by step. Los Angeles, CA: Sage.

Ingram, J., Johnson, D., Condon, L. (2011). The effects

of Baby Friendly Initiative training on breastfeeding rates, and the breastfeeding attitudes, knowledge and self-efficacy of community health-care staff. Primary Health Care Research & Development, 12, 266-275. doi:10.1017/S1463423610000423 [PubMed: 21798124].

Ip, S., Chung, M., Raman, G., Magula, N., DeVine, D.,

Trikalinos, T., & Lau, J. (2007). Breastfeeding and

maternal and infant health outcomes in developed

countries. Rockville, MD: Agency for Healthcare Research and Quality. (Evidence Report/Technol- ogy Assessment No. 153). AHRQ Publication No. 07-E007.

APPENDIXB @

Lee, H. C., & Gould, J. B. (2009). Factors influencing

breast milk versus formula feeding at discharge for very low birth weight infants in California. Journal of Pediatrics, 155, 657-662. [PubMed: 19628218].

Lessen, R., & Crivelli-Kovach, A. (2007). Prediction of

initiation and duration of breastfeeding for neonates admitted to the neonatal intensive care unit. Journal of Perinatal Nursing, 21, 256-266. doi:10.1097/01. JPN.0000285817.51645.73.

Lucas, A. (2005), Long-term programming effects of early nutrition — Implications for the preterm infant. Journal of Perinatology, 25, S2-S6. doi:10.1038/ s}.jp-7211308 [PubMed: 15861165].

Matthew-Meich, N., Ploeg, J., Jack, S., & Dobbins, M. (2012). Leading on the frontlines with passion and persistence: A necessary condition for Breastfeeding Best Practice Guideline uptake. Journal of Clinical Nursing, 22, 1759-1770. doi:10.1111/jocn.12027 [PubMed: 23186340].

Meier, P. P., Patel, A. L., Bigger, H. R., Rossman, B.,

& Engstrom, J. L. (2013). Supporting breastfeeding in the neonatal intensive care unit: Rush Moth- er’s Milk Club as a case study of evidence-based care. Pediatric Clinics of North America, 60(1), 209-226. doi:10.1016/j.pcl.2012.10.007 [PubMed: 23178066].

Merewood, A., Brooks, D., Bauchner, H., MacAuley,

L., & Mehta, S. D. (2006). Maternal birthplace and

breastfeeding initiation among term and preterm infants: A statewide assessment for Massachusetts. Pediatrics, 118(4), e1048-e1054. doi:10.1542/ peds.2005-2637 [PubMed: 17015498].

Michi, S., Johnston, M., Abraham, C., Lawton, R.,

Parker, D., Walker, A., & Psychological Theory Group., (2005). Making psychological theory useful

for implementing evidence based practice: A consen- sus approach. Quality and Safety in Health Care, 14, 26-33. doi:10.1136/qshc.2004.011155 [PubMed: 15692000].

Miles, M. B., Huberman, A. B., & Saldana, J. (2014).

Qualitative data analysis: A methods sourcebook. Los Angeles, CA: Sage.

Miracle, D. J., Meier, P. P., & Bennett, P. A. (2004).

Mothers’ decisions to change from formula to moth- ers’ milk for very-low-birth-weight infants. Journal

of Obstetric, Gynecologic and Neonatal Nursing, 33, 692-703. doi:10.1177/088421750427066S.

Niela-Vilen, H., Axelin, A., Melender, H. L., &

Salantera, S. (2014). Aiming to be a breastfeeding mother in a neonatal intensive care unit and at home: A thematic analysis of peer-support group discussion in social media. Maternal and Child Nutrition. doi:10.1111/men.12108. Advance online

publication. Ouyang, Y. -Q., Xu, Y. -X., & Zhang, Q. (2012).

Survey on breastfeeding among Chinese female phy- sicians and nurses. Nursing and Health Sciences, 14, 298-303. doi:10.1111/j.1442-2018.2012.00699.x [PubMed: 22827770].

Reprinted

with permission.

Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses 243

Patton, M. (2015). Qualitative research and evaluation

methods. Thousand Oaks, CA: Sage. Pink, S. (2012). Situating everyday life. Los Angeles:

Sage.

Qualitative Solutions and Research Pty Ltd. (1997). OSR NUD *IST user guide. Thousand Oaks, CA: Sage.

Renfrew, M. J., Craig, D., Dyson, L., McCormick,

F., Rice, S., King, S. E., & Williams, A. F. (2009).

Breastfeeding promotion for infants in neonatal units: A systematic review and economic analysis. Health Technology Assessment, 13(40), 1-146.

doi:10.3310/hta13400 [PubMed: 19728934]. Rubin, H. J., & Rubin, I. $. (2012). Qualitative inter-

viewing: The art of hearing data. Los Angeles: Sage. Spatz, D. L. (2010). The critical role of nurses in

lactation support. Journal of Obstetric, Gynecologic and Neonatal Nursing, 39, 499-500. doi:10.1111/

j.1552-6909.2010.01166.x.

Spear, H. J. (2004). Nurses’ attitudes, knowledge,

and beliefs related to the promotion of breast- feeding among women who bear children during adolescence. Journal of Pediatric Nursing, 19,

176-183. doi:10.1016/j.pedn.2004.01.006 [PubMed:

15185246]. Sullivan, S., Schanler, R. J., Kim, J. H., Patel, A. L.,

Trawoger, R., Kiechl-Kohlendorfer, U., & Lucas, A.

(2010). An exclusively human milk-based diet is as-

sociated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. Journal of Pediatrics, 156, 562-567. el. doi:10.1016/j.jpeds.2009.10.040 [PubMed:

20036378]. Taylor, C., Gribble, K., Sheehan, A., Schmied, V., &

Dykes, F. (2011). Staff perceptions and experiences of implementing the Baby Friendly Initiative in

neonatal intensive care units in Australia. Journal of Obstetric, Gynecologic and Neonatal Nursing, 40,

25-34. doi:10.1111/j.1552-6909.2010.01204.x.

Vohr, B. W., Poindexter, B. B., Dusick, A. M., McKin-

ley, L. T., Wright, L. L., & Langer, J. C. (2006).

NICHD Neonatal Research Network. Beneficial

effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics, 118(1), e115-e123. doi:10.1542/peds.2005-2382

[PubMed: 16818526]. Wheeler, J., Chapman, C., Johnson, M., & Lang-

don, R. (2000). Feeding outcomes and influences

within the neonatal unit. International Journal of Nursing Practice, 6, 196-206. doi:10.1046/}.1440-

172X.2000.00207.x [PubMed: 11261049]. World Health Organization/United Nations Children’s

Fund. (1992). Baby Friendly Hospital Initiative. Geneva, Switzerland: Author.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

244 APPENDIXB ® _ Infant Feeding Beliefs and Day-to-Day Feeding Practices of NICU Nurses

he Highlights

Breastfeeding was viewed as more effort than formula feeding in daily practice.

Breastfeeding evoked emotions of anxiety, embarrassment, and frustration in NICU nurses.

Nurses with breastfeeding training were more committed to breastfeeding promotion.

Mandatory breastfeeding training should address emotional and educa- tional needs of nurses.

APPENDIX C.

A NurseE-FAciLitATED DEPRESSION SCREENING PROGRAM IN AN ARMY PRIMARY Care CLINIC An Evidence-Based Project

Edward E. Yackel * Madelyn S.McKennan e Adrianna Fox-Deise

> Background: Depression, sometimes with change. Approximately 130 patients a month were

suicidal manifestations, is a medical condition

commonly seen in primary care clinics. Routine

screening for depression and suicidal ideation is

recommended of all adult patients in the primary

care setting because it offers depressed patients

a greater chance of recovery and response to

treatment, yet such screening often is overlooked

or omitted.

Objective: The purpose of this study was to

develop, to implement, and to test the efficacy

of a systematic depression screening process to

increase the identification of depression in family

members of active duty soldiers older than 18 years

at a military family practice clinic located on an

Army infantry post in the Pacific.

Methods: The |owa Model of Evidence-Based

Practice to Promote Quality Care was used to

develop a practice guideline incorporating a

decision algorithm for nurses to screen for de-

pression. A pilot project to institute this change

in practice was conducted, and outcomes were

measured.

Results: Before implementation, approximately

100 patients were diagnosed with depression

in each of the 3 months preceding the practice

assigned a 311.0 Code 3 months after the practice

change, and 140 patients per month received

screenings and were assigned the correct Interna-

tional Classification of Diseases, Ninth Revision

Code 311.0 at 1 year. The improved screening

and coding for depression and suicidality added

approximately 3 minutes to the patient screening

process. The education of staff in the process

of screening for depression and correct coding

coupled with monitoring and staff feedback

improved compliance with the identification and

the documentation of patients with depression.

Nurses were more likely than primary care provid-

ers to agree strongly that screening for depression

enhances quality of care.

Discussion: Data gathered during this project

support the integration of military and civilian

nurse-facilitated screening for depression in

the military primary care setting. The decision

algorithm should be adapted and tested in other

primary care environments.

Key Words: decision algorithm - depression

screening - evidence-based practice - military

primary care clinic

Reprinted with permission from Yackel, E.E., McKennan, M. S., and Fox-Deise, A. (2010). A nurse-facilitated depression 245

screening program in an Army primary care clinic: An evidence-based project. Nursing Research, 59(1 Suppl), S68-S65.

246 APPENDIXC #® A Nurse-Facilitated Depression Screening Program

Mental illness ranks first among morbidities

that cause disability in the United States,

Canada, and Western Europe, with the

associated healthcare cost in the United States

estimated at $150 billion in 2003 (Centers

for Disease Control and Prevention [CDC],

2003). A psychometric comparison of military

and civilian populations in primary care settings revealed no statistical difference in

the prevalence of mood disorders (Jackson,

O’Malley, & Kroenke, 1999). However,

Waldrep, Cozza, and Chun (2004) found

that the deployment of a spouse or parent can challenge the ability of a military family

member to cope with a preexisting medical or

mental health illness. These authors recom- mended that clinicians identify those family members who require additional services

and suggested actions that might mitigate the

impact of deployment on the family unit. Depression is a common medical condi-

tion seen frequently in primary care clinics.

Patients with depression who present to

primary care clinics have a greater chance

of responding to treatment and recovery if primary care providers screen for depression

using a short self-administered questionnaire

as part of a comprehensive disease manage-

ment program (DMP). The role of nurses in

the process of screening for depression has yet to be delineated, so this evidence-based prac-

tice (EBP) project was designed to develop,

to implement, and to evaluate a standardized nursing procedure to improve the screening of

family members for depression at a military

family practice clinic located on a U.S. Army

infantry post in Hawaii. This EBP project

was based on the Veterans Administration/

Department of Defense Behavioral Health Clinical Practice Guideline (VA/DoD BHCPG,

2002) for screening and treatment of depres- sion as the DMP to guide practice change.

The absence in this clinic of a systematic method to screen family members of deployed soldiers for depression and the inability to

estimate rates of depression in this clinical

population were the problem-focused triggers

for this project. National standards and guidelines that call for the screening of all

adults for depression in primary care settings,

such as the VA/DoD BHCPG (2002) and the

recommendations and rationale published by the U.S. Preventive Services Task Force

(USPSTF, 2002), were the knowledge-focused

triggers that guided practice change in this

primary care clinic. A multidisciplinary panel of stakeholders—

advanced practice registered nurses (APRNs),

physicians, certified nurse assistants (CNAs), registered nurses (RNs), psychologist, and

clinic administrators—formed the EBP team.

This team was led by a change champion (an APRN) and an opinion leader (a physician).

The change champion was an expert clinician

who had positive working relationships with

other healthcare professionals and who was

passionate and committed about screening

for depression in primary care. Similarly, the

opinion leader was viewed as an important

and respected source of influence among his

peer group, demonstrated technical compe- tence, and excelled as a teacher and mentor

on the subject of depression. The EBP team

met to review both problem- and knowledge-

focused triggers and determined that screening for depression was a priority for the organi-

zation. The EBP project received enthusiastic

support throughout the organization and at

the highest levels of nursing leadership. Because of the relevance to the outpatient

setting in taking into account clinical decision

making, the clinician, and organizational

perspectives (Titler et al., 2001), the Iowa

Model of Evidence-Based Practice to Promote

Quality Care (see the Titler and Moore

editorial in this supplement) was chosen to

guide an EBP improvement systematically in a military primary practice clinic.

LITERATURE REVIEW

The published medical and nursing literature was reviewed to identify studies evaluating

the efficacy of screening for depression in primary care and methodological approaches to such screening. The MEDLINE, the

Cochrane, and the Cumulative Index to

APPENDIXC

Nursing and Allied Health Literature data- bases were searched for English-language

articles using eight subject headings (primary care, clinical practice guidelines, mental health, depression instruments, depression

screening, suicide screening, military health-

care, and deployment). In addition, bibliog- raphies of the articles obtained were searched

for relevant articles to generate additional

references. Editorials were rejected, as were

articles with data targeting pediatric popula-

tions exclusively. Two guidelines (graded as

Level I), 3 Level I articles, 17 Level II articles,

and 10 Level III articles were critiqued using

USPSTFE criteria by two APRNs, a physician, and a nurse researcher for inclusion in a

literature synthesis. Level I articles included evidence obtained from at least one random-

ized controlled trial. Level II articles included

evidence from well-designed controlled trials

without randomization (classified as Level II-

1), evidence from cohort or case-control ana-

lytic studies (Level II-2), and evidence from

multiple time series with or without interven-

tion (Level II-3). Level II articles included

opinions of respected authorities that were based on clinical experience or descriptive studies and case reports (Harris et al., 2001).

The literature synthesis (Table 1) facilitated

the categorization of articles into three focus areas: (a) prevalence of depression in primary care populations; (b) depression management

programs and evaluation of suicidal risk; and (c) depression screening instruments and their

use In primary care settings.

Prevalence of Depression. Depression

is a common medical condition associated

with high direct and indirect healthcare costs (Badamgarav et al., 2003; Valenstein,

Vijan, Zeber, Boehm, & Buttar, 2001).

Dickey and Blumberg (2002) analyzed data

from the 1999 National Health Interview Survey and found that 6.3% or 12.5 million

noninstitutionalized U.S. adults suffer from

major depression. The prevalence of major depression in primary care settings is 5% to

9% among adults, with half of these unrec-

ognized and untreated (Hirschfeld et al.,

Reprinted

with permission.

A Nurse-Facilitated Depression Screening Program 247

1997; Hunter, Hunter, West, Kinder, &

Carroll, 2002; Simon & VonKorff, 1995).

Depressive illness in primary care is less

severe than in mental health settings; thus,

the short-term prognosis, the chance of

recovery, and the response to treatment

are greater in primary care settings (Dickey

& Blumberg, 2002; Pignone et al., 2002;

Simon & VonKorff, 1995).

Within the next 20 years, depression is

projected to be the second highest cause of disability in the world and to have a lifetime

prevalence of 15% to 25% (Badamgarav et

al., 2003). Depression has been shown to

increase the morbidity and mortality associ-

ated with other chronic diseases, such as dia-

betes and cardiovascular disorders (Hunter et

al., 2002; Pignone et al., 2002). Furthermore,

family members of patients with depres- sion have increased physical morbidity and

psychopathology (Sobieraj, Williams, Marley,

& Ryan, 1998). A majority of adult patients with mental health concerns such as depres- sion will seek and receive care in primary care

settings (Dickey & Blumberg, 2002; Pignone et al., 2002).

The lifetime suicide risk for all patients diagnosed with major depressive disorder

has been estimated as 3.5% (Blair-West,

Mellsop, & Eyeson-Annan, 1997). Harris and

Barraclough (1997) found a 12- to 20-fold risk for suicide associated with depressive

disorder using the general population for comparison. Suicide is the second-leading

cause of death among those aged 25 to 34 years, accounting for 12.9% of all deaths annually (CDC, 2007). Luoma, Martin, and

Pearson (2002) reviewed 40 studies examining

rates of contact with primary care providers

before suicide and found that approximately

45% of patients who committed suicide had contact with a primary care provider within

1 month of taking their lives, suggesting

that screening for risk of suicide in patients with depression is important in primary care

settings. Although the literature supports the

efficacy of DMPs that include screening for depression, the USPSTF (2004) found insuf-

ficient evidence to recommend for or against

Generating and Assessing Evidence for Nursing Practice (11th ed.)

248 APPENDIXC = A Nurse-Facilitated Depression Screening Program

Table 1 Selected Literature Synthesis ——

Focus Area Journal or Source Year Description Level of Evidence

Prevalence of General Hospital 1995 Literature review Literature

depression Psychiatry synthesis

JAMA 2006 Population-based Level Il-3

descriptive study

Military Medicine 1999 Psychometric Level II-3

comparison: military

vs. civilian

Archives of Family 1995 Epidemiological study Level Il-2

Medicine with 1-year follow-up

Journal of the 2005 Descriptive study Level Ill

American Board

Family Practice

Military Medicine 2002 Comparative study: PHO Level II-3

vs. progress notes

Iraq War Clinicians 2004 Opinion by respected Level Ill

Guide authority

American Journal of 2003 Meta-analysis Level |

Psychiatry

National Mental 1999 Survey report Level Ill

Health Information

Center

JAMA 1997 Consensus statement Level Ill

Depression Annals of Internal 2002 Systematic literature Guideline/

management Medicine review Level |

programs and

evaluation of

suicide risk

General Hospital 1992 Abstract Level Ill

Psychiatry

American Journal of 2002 Meta-analysis of Level Ill

Psychiatry descriptive studies/

reports

Journal of General 1996 Structured interviews, Level Il-1

Internal Medicine comparison of three

studies

Annals of Family 2005 Randomized controlled Level |

Medicine trial

British Journal of 1997 Meta-analysis Level II-1

Psychiatry

Centers for Disease 2007 +Report/literature review Level Ill

Control and

Prevention

APPENDIXC ® A Nurse-Facilitated Depression Screening Program 249

Table 1 (continued) Pa ee sees BN Re eS a

Focus Area Journal or Source Year Description Level of Evidence

Depression American Journal of 2004 Psychometric Level II-3 screening Managed Care comparison of one-

instruments item depression screen

versus PHO

Journal of General 1997 Comparing validity of Level II-2

Internal Medicine PHO-2 to validity of

other known measures

Medical Care 2003 Survey, nonrandomized Level II-2

Psychotherapy and 2004 Descriptive comparison Level II-3

Psychosomatics of three questionnaires

Journal of General 2001 PHQ-9 compared with Level II-2

Internal Medicine

Department of 2000

Veterans Affairs

JAMA 1999

American Journal 2000

of Obstetrics and

Gynecology

other measures/

nonrandomized

Clinical practice guideline Guideline/

level |

Criterion standard study: Level |

PRIME MD

Validity study of PHO Level II-2

in obstetrician-

gynecologist patients

Note. Level I articles included evidence obtained from at least one randomized controlled trial. Level II articles included evidence from well-designed controlled trials without randomization (classified as Level II-1), evidence from

cohort or case-control analytic studies (Level II-2), and evidence from multiple time series with or without interven-

tion (Level II-3). Level III articles included opinions of respected authorities that were based on clinical experience or descriptive studies and case reports (Harris et al., 2001).

screening for risk of suicide by primary care

clinicians. Focusing on the detection and care of patients with depression who are at higher

risk for self-harm and improving the ability of primary care providers to identify and to treat

those at risk for suicide are suggested strate- gies for suicide prevention efforts (Luoma et

al., 2002; Schulberg et al., 2005).

DEPRESSION SCREENING INSTRUMENTS

A variety of self-administered questionnaires are available for assessing the severity of depression and risk of suicide in primary care. The Patient Health Questionnaire depression module (PHQ-9) and a two-item version of

the PHQ depression module, the PHQ-2,

Reprinted

with permission.

provide primary care providers with valid and reliable measures to assess patients with depression in busy primary care settings

(Kroenke, Spitzer, & Williams, 2001, 2003).

The PHQ-9 is the self-administered depres-

sion module of the Primary Care Evaluation

of Mental Disorders (a diagnostic instrument

for common mental disorders designed for primary care providers to assess the cognitive and physical symptoms of depressive dis- orders; Hunter et al., 2002). Kroenke et al.

(2001) examined the validity of the PHQ-9 by analyzing data from 6,000 patients aged 18 years or older who had completed the

PHQ-9 in eight primary care clinics and seven obstetrics-gynecology clinics. Recent data show that the PHQ-9 has a sensitivity

of 88% and a specificity of 88% for major

Generating and Assessing Evidence for Nursing Practice (11th ed.)

250 APPENDIXC #

depression, with excellent internal reliabil-

ity (a = .89) and validity in measuring the

severity of depression (Corson, Gerrity, &

Dobscha, 2004; Kroenke et al., 2001). Lowe

et al. (2004) compared the criterion valid- ity of the PHQ-9 for diagnosing depressive

episodes with two other well-established

instruments and concluded that the PHQ-9

demonstrated a diagnostic advantage and had superior criterion validity when compared with the other instruments. The last item of

the PHQ-9 assesses patients for suicidal risk,

which is one of the diagnostic criteria for

depressive disorders. Feeling suicidal predicts

plans to attempt suicide with 83% sensitivity, 98% specificity, and 30% positive predictive

value when asked as a single self-report item

(Olfson, Weissman, Leon, Sheehan, & Farber,

1996). Corson et al. (2004) reported that use

of the PHQ-9 death or suicide item identified one third (7%) of patients in a VA primary

care clinic with active suicidal ideation who

would not have been treated otherwise.

Shorter screening tests with questions about depressed mood and anhedonia

(inability to have pleasurable feelings) appear

to detect a majority of depressed patients

(Pignone et al., 2002). The PHQ-2 is a self- administered questionnaire used to ascer-

tain the frequency of depressed mood and anhedonia over the past 2 weeks. Kroenke

et al. (2003) established the criterion valid-

ity of the PHQ-2 by comparing its operat-

ing characteristics with an interview by an independent mental health provider and

reported a sensitivity of 83% and a specific- ity of 92%. Corson et al. and Kroenke et al.

reported 97% sensitivity and 91% specificity

for depression when using the PHQ-2 to screen for this disorder in a VA primary care

setting. Thus, the literature provides strong evidence for the validity of the PHQ-2 as a brief screening measure that facilitates the

diagnosis of major depression. However, it

is recognized as an initial step ina DMP that requires further assessment and implementa-

tion to care for patients with major depres- sion (Corson et al., 2004; Kroenke et al.,

20033; USPSTF, 2002).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

A Nurse-Facilitated Depression Screening Program

The VA/DoD BHCPG (2002) for screening

and treatment of depression is an example of

a DMP that includes screening for depression and suicide. The guideline is designed for use by providers who care for patients with depression in military primary care clinics.

The VA/DoD BHCPG DMP describes (a)

the screening and recognition of depression and suicidal ideation; (b) the assessment of

physical and mental status; (c) the diagnostic criteria and assessment of risk factors; (d) a

treatment plan that includes suggestions for managing medications, counseling, and refer-

ral criteria; (e) patient and family education;

and (f) the monitoring and documentation of follow-up. The VA/DoD BHCPG is designed for the primary care setting and describes the role of primary care providers, but it does not explicate the role of nursing staff in imple- menting the process.

Evidence has been found that screening

improves the identification of depressed patients and that effective follow-up and treatment of depressed adults decrease

clinical morbidity in primary care settings

(USPSTF, 2002). Evidence-based guidelines,

patient education, collaborative and multi-

disciplinary care, and monitoring are used in DMPs to provide comprehensive care

for patients with chronic diseases such as depression (Badamgarav et al., 2003). The

DMPs that include screening for depression

are more effective than the programs that are focused on depression screening alone (Biyl, van Marwijk, de Haan, van Tilburg,

& Beekman, 2004; Pignone et al., 2002).

Badamgarav et al. (2003) systematically

reviewed the published medical literature evaluating the effectiveness of DMPs for chronic conditions such as depression and

found that disease management improves the detection and care of patients with depres- sion. Similarly, a systematic review and a

meta-analysis of randomized controlled trials

of DMPs for depression concluded that the costs of depression programs are within the

cost range of other public health improve- ments and that enhanced quality of care is possible (Neumeyer-Gromen, Lampert, Stark,

Reprinted

with permission.

APPENDIXC &

& Kallischnigg, 2004). Primary care provid- ers play a vital role in DMPs to improve the

detection and care of patients with depres- sion. Notably absent from the literature are descriptors of nursing processes that facilitate screening for depression and the role that

nurses play in the DMPs. The purpose of this EBP project was to implement and to evaluate the change process methodology involved in

screening family members of military active

duty soldiers for depression.

SETTING

The setting for this EBP project was a military

family practice clinic with an enrollment of 14,322 family members and approximately 175 daily patient visits. Before implementation of the project, only female family members were screened routinely for depression (at

wellwoman visits), and nurses did not partici-

pate in screening for depression. This process

resulted in 100 cases of depression being captured a month. Family members of military

active duty soldiers older than 18 years who

could read, write, and communicate in English

were screened. Patient care was documented in

a hard-copy medical record or in the military’s

electronic medical record, the Armed Forces

Health Longitudinal Technology Application (AHLTA). The selection of the screening

process for the EBP project was based on the VA/DoD BHCPG for screening and treatment

of depression and similar patient populations studied by other investigators (Kroenke et al., 2003; Olfson et al., 1996). All military

family members have open access to mental health services. Patients who require inpatient

psychiatric care are referred by their primary care provider or mental health provider to a

regional military medical center.

IMPLEMENTATION: DECISION ALGORITHM

Two questions from the PHQ-2 (“During the past month, have you often been bothered by feeling down, depressed or hopeless?” and

Reprinted

with permission.

A Nurse-Facilitated Depression Screening Program 251

“During the past month, have you often been bothered by little interest or pleasure in doing

things?”) and one question from the PHQ-9 (“Do you have thoughts that you would be

better off dead or hurting yourself in some way?”) were selected for use in the project. The decision algorithm for nurses (Figure 1)

integrates the PHQ-2 and the PHQ-9 questions as steps in the depression screening process.

The first step of the depression screening pro- cess prompts nursing staff to ask the PHQ-2 questions in an effort to determine the presence of depressed mood or anhedonia. A negative

response to the PHQ-2 questions concludes the depression screening process, and the primary care provider addresses the patient’s primary

complaint. The second step of the screen- ing process directs nurses to ask the PHQ-9

question (suicidal ideation) when a positive response is given to either of the PHQ-2 ques- tions. A patient who denies suicidal ideation is given a depression handout listing behavioral

health support services, locations of clinics,

and contact numbers. Subsequently, the patient

is offered a follow-up appointment in 1 or 2 weeks with the primary care provider to

discuss assessment and treatment of depres- sion. The patient’s appointment continues after the nurse reports the results of the depression screening to the primary care provider. A patient who responds positively to the PHQ-9

(red flag) question is referred immediately to a mental health professional for further evaluation. Documentation of the depression

screening process is completed by nurses in

the AHLTA system. Primary care providers are encouraged to use the VA/DoD BHCPG to

assess and to treat patients with depression.

PILOTING THE CHANGE

Creating an environment for a practice change

to occur is an important element in the EBP

process; therefore, a pilot project was under- taken to identify barriers in implementing the decision algorithm. A physician, a CNA, and

two RNs (a nurse researcher and a research

assistant) from the EBP team were selected

Generating and Assessing Evidence for Nursing Practice (11th ed.)

252 APPENDIXC # A Nurse-Facilitated Depression Screening Program

Patient Arrives

2 Depression

Questions

Asked *

Red Flag

Question

Asked *

Notify Provider

MIL: Escort to

Mental Health

See Depression

CPG for Providers yp

CIV: Page Mental

Health & Monitor

Notes.

Appt = Appointment CPG = Clinical Practice Guideline

CIV = Civilian or Family Member _ f/u = Follow-Up

% indicates steps for nurses to take in the screening process

Figure 1. A decision algorithm for nurses.

Negative

Positive Screen

Negative

Positive Screen

Continue with

appointment

Depression

Handout

Appt. slip for f/u

with PCM In 1-2 weeks

Notify Provider

MIL = Military

PCM = Primary Care Manager

to model the change in clinical practice process and outcomes and to make recom-

over a 3-day period. The experienced nurse mendations aimed at improving the process. researcher instructed the CNA on depression,

depression screening, and integration of the

EBP decision algorithm into existing screening INSTITUTING THE CHANGE IN PRACTICE practices by providing verbal education and

written materials. The CNA was required to Feedback from all participants in the pilot

verbalize and to demonstrate the use of the project was used to formulate six recom-

decision algorithm before starting the pilot. mendations aimed at minimizing barriers in All patients meeting the inclusion criteria were implementing the decision algorithm and in screened for depression using the decision instituting the change in practice: (a) inte- algorithm. The experienced nurse researcher grate the PHQ-2 and the PHQ-9 depression and research assistant observed screening screening questions into both the hard-copy practices during the pilot to evaluate the medical record and the AHLTA system to

APPENDIXC @ _

add continuity during unscheduled computer downtime; (b) educate staff (providers and nurses) on the decision algorithm and the doc- umentation process for both hard-copy and electronic medical records; (c) provide depres- sion awareness education by a mental health professional to increase the nursing staff’s comfort when asking questions about depres- sion; (d) post the decision algorithm at the

nursing team center to foster recognition and

comprehension; (e) display depression posters prominently in patient care areas to sensitize

the patient population to this common mental health condition; and (f) educate providers (physicians, APRNs, and physician assis- tants) on the need to document and use the

International Classification of Diseases, Ninth

Revision (ICD-9) Code 311.0 (depressive dis-

order, not otherwise specified) consistently to

simplify data retrieval from military medical databases. Forty staff members (RNs, LPNs,

CNAs, APRNs, PAs, and MDs) were educated

in using the decision algorithm and the docu- mentation process for both the hard-copy and

the electronic medical record by the family practice clinic head nurse (EBP team member).

A psychologist provided depression educa- tion to 17 nurses (RN, LPN, or CNA). This

included the definition of depression, how to approach asking questions on depression, and role playing the depression screening process. Thirteen of the family practice clinic providers (100%) were educated by the opinion leader

on the use of Code 311.0 to document the diagnosis of depression. Depression posters were displayed in patient care areas, the deci-

sion algorithm was displayed at the nursing team center, and the PHQ-2 and the PHQ-9 questions were integrated into the hardcopy and the AHLTA medical record.

@ Results

OUTCOME MEASURES

Four measures were used to assess the

success of implementing the EBP decision

Reprinted

with permission.

A Nurse-Facilitated Depression Screening Program 253

algorithm in the family practice clinic: (a) number of patients diagnosed with depres-

sion; (b) satisfaction of providers and nurses;

via random chart audits); and (d) time-

motion evaluation of the patient screening

process. Data collection began 3 months

after implementation of the decision algo- rithm by the RN researcher.

An assessment of the numbers of patients diagnosed with depression was based on data gathered from a military medical database

to establish the number of family members

diagnosed with depression in the family

practice clinic using the ICD-9 Code 311.0 before and after the practice change. With nurses administering the depression screen-

ing to all adult patients (not just females)

and providers using Code 311.0 to identify

those with depression, approximately 130 patients a month were assigned a Code 311.0 3 months into the practice change and 140 patients a month at 1 year after the practice

change (Figure 2). A possible correlation

between deployment of soldiers to Irag and increase in the number of family members

presenting for treatment of depression was not examined.

The satisfaction of providers and nurs-

ing staff was measured at 3 and 12 months

after the change in practice using one

question answered on a 4-point Likert scale: “Implementing depression screening enhances

the quality of care in the family practice clinic.” Participants rated their level of agree- ment from 1 (strongly disagree) to 4 (strongly

agree). Three months after implementation,

64% of the nurses and 45% of the providers strongly agreed that screening for depression enhanced the quality of care in the clinic. At 1 year after the implementation of the decision algorithm, 95% of nurses and 54% of provid-

ers strongly agreed that screening for depres-

sion enhanced the quality of care. The nurse researcher evaluated staff

compliance in documenting the process of

screening for depression using a standardized audit form to review systematically selected

(every fourth record from 11 providers)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

254 APPENDIX C # A Nurse-Facilitated Depression Screening Program

KEY

Pre-Practice

Change = Black

Post-Practice

August 2006: Providers educated

September 2006: Nursing staff educated

Change = White

SO ye oS

November 2006: Decision algorithm implemented x«

Figure 2. Number of depression cases before and after practice change.

electronic medical records. Thirty records

that met selection criteria were audited at

3 months, and 30 different records were

audited at 6 months after the practice change

was implemented. The number of records to

audit was determined on the basis of patient visits per day and the rate of major depres-

sion in primary care (S5—9%) obtained from the literature review. Three months into the practice change, 26 (87%) of 30 reviewed charts showed evidence of documentation for depression screening; 7 (27%) of 26 charts

verified that patients screened for depression were positive for depressed mood or anhedo- nia without suicidal ideation. Six months after

the practice change, evidence of documenta-

tion for depression screening was shown in

29 (97%) of the 30 charts, and patients who

were screened for depression were positive for depressed mood or anhedonia without suicidal ideation in 10 (33%) charts. The

nurse researcher was unable to determine the

compliance of nursing staff in documenting notification of a mental health provider, given that no cases of suicidal ideation were identified in the audited charts. An important

Generating and Assessing Evidence for Nursing Practice (11th ed.)

facet of compliance with documentation throughout the institutionalization of the decision algorithm was continual educatien

and feedback to both providers and nurses on

requirements.

Time-motion data were collected for the length of time it took to screen patients.

The screening process included greeting the

patient, obtaining weight and vital signs, escorting the patient into an examination

room, reviewing demographic data, reviewing

the screening questions on depression and

suicide, and entering data into the AHLTA

system. Variability among the nurses in the

process for screening patients during the first month of the project initially resulted in a

time variance of 11 minutes, with a range of

5 to 30 minutes for each screening. The clinic

head nurse standardized the screening process

by asking the nurses to enter data into the AHLTA in the examination rooms instead of returning to the team center. This resulted in

a mean time reduction of 4 minutes, 58 sec-

onds after the practice change. The mean time

added per patient encounter after the practice change was 2 minutes, 53 seconds.

Reprinted

with permission.

APPENDIXC & o~

= Discussion

Data gathered during the EBP project support

the relevance of a nurse-facilitated program to

screen for depression in a primary care setting.

The VA/DoD BHCPG is designed for primary care and describes the role of primary care

providers in the DMP but it does not describe the role of nurses in the depression screening

process. The decision algorithm was a valu-

able tool defining the steps to be followed by nurses when screening patients for depression.

More important, incorporating nurses into the

depression screening process accomplished the

first step of the VA/DoD BHCPG in a multi- disciplinary effort consistent with recommen- dations found in the literature.

Nurses can be instrumental in depression

screening in the primary care setting, leading

to appropriate referral for further care. The prevalence, the morbidity, and the mortality

associated with depression necessitate that nurses be involved integrally in this process as

part of the healthcare team. In this pilot proj- ect, one provider, a CNA, and two RNs iden-

tified barriers in implementing the decision algorithm into the business practices of the family practice clinic. Although procedural barriers to the implementation of the deci- sion algorithm were addressed, incorporating the process of screening for depression into existing screening practices was not clearly

defined. The wide range seen in screening times during the first month of the project was

most likely related to procedural differences in

whether nursing staff entered vital signs and questionnaire data into the electronic medical

record (the AHLTA) during or after seeing the patient. Standardization of the time of data entry improved screening times. A mandatory

program for reconciling medications was implemented during the EBP project and may

have affected the outcome of the time—motion

study because the effects of implementing both screening for depression and medication reconciliation might have been measured.

A majority of staff members strongly agreed that screening for depression is a

Reprinted

with permission.

A Nurse-Facilitated Depression Screening Program 255

quality component of clinical practice, despite both providers and nurses acknowledging an increased workload because of the EBP

project. The decision algorithm was designed to allow primary care providers the option

of implementing the VA/DoD BHCPG upon

notification of screening results by nurses. The hope was that if the nursing staff followed the

procedural steps outlined in the decision algo- rithm, the need for providers to intercede in the process of screening for depression would be mitigated. However, clinical assessment of

the presenting illness and trends in patients’ healthcare utilization may have affected how providers responded to the screening

results. Some providers were not comfortable with the process of screening for depression, which may have played a role also in how

they responded to patients who reported anhedonia or depressed mood. Conversely, nurses who were comfortable with screening

for depression were more likely to respond that such screening enhanced the quality of patient care. The difference between nurse

and provider levels of comfort may have been the result of the difference in the educational

offerings presented to each group. Nurses were offered depression awareness train- ing and repeated education on the decision algorithm and documentation requirements, whereas providers were educated only on the

management of depression in primary care

and implementation of the decision algorithm. Standardization of educational offerings for

all members of the healthcare team is recom- mended to provide consistent information and

continuity of care and to foster trust in the

depression screening process.

Both providers and nurses considered

depression screening beneficial to family members of deployed soldiers. One year after

the practice change, 10 providers were asked to reflect on how many patients had a positive screening for suicidal ideation that required

immediate referral to a behavioral health

specialist. These providers estimated that approximately 36 patients reported suicidal ideation who would not otherwise have been

detected. Although no data were obtained on

Generating and Assessing Evidence for Nursing Practice (11th ed.)

256 APPENDIXC

the relationship between the deployment of soldiers and reports of depression and suicidal ideation by family members, further study

on the relationship between these variables is recommended.

IMPLICATIONS FOR PRACTICE AND RESEARCH

The integration of a nurse-facilitated depression

screening program into the business practices

of a busy military family practice clinic was viewed by providers, nursing staff, and nursing leadership as a quality component of clinical

practice that benefited the population served.

The Iowa Model of Evidence-Based Practice

to Promote Quality Care (Titler et al., 2001)

and the decision algorithm for nurses were essential tools in implementing practice change and appear to have great utility in the primary

care setting. The use of an EBP model provides

a systematic method for nurses to evaluate

critically, to define, and to implement changes in

practice. The decision algorithm for nurses was a valuable tool in the depression screening pro-

cess and should be tested in other primary care settings. In addition, further study is warranted to determine whether having nurses screen for

depression influences the practice patterns of

primary care providers when implementing a

DMP such as the VA/DoD BHCPG.

Edward E. Yackel, MSN, RN, FNP-BC, is Lieu-

tenant Colonel, U.S. Army Nurse Corps, McDon-

ald Army Health Center, Fort Eustis, Virginia.

Madelyn S. McKennan, MSN, RN, FNP-BC, is

Lieutenant Colonel, U.S. Army Nurse Corps,

Schofield Barracks Army Health Clinic, Hono-

lulu, Hawaii.

Adrianna Fox-Deise, RN, FNP, is Instructor, School

of Nursing and Dental Hygiene, University of

Hawaii at Manoa.

Accepted for publication September 30, 2009. This project was funded by an award from the TriService Nursing Research

Program, grant no. NO3-P18. The

Uniformed Services University of the

Generating and Assessing Evidence for Nursing Practice (11th ed.)

A Nurse-Facilitated Depression Screening Program

Health Sciences (USUHS), 4301 Jones

Bridge Rd., Bethesda, MD 20814-4799,

is the awarding and administering office. This project was sponsored by the TriService

Nursing Research Program, Uniformed Services University of the Health Sciences;

however, the information or content and

conclusions do not necessarily represent

the official position or policy of, nor should any official endorsement be inferred by, the TriService Nursing Research

Program, Uniformed Services University

of the Health Sciences, the Department of Defense, or the U.S. Government.

The following people contributed to the study: Nathan DeWeese, MD; Ms. Renee

Latimer, RN, MPH; Mrs. Charlotte

Grant, NA; Mr. Wesley Grant, NA;

Richard Schobitz, PhD; and Mr. Adrian

Santos, RN, BSN.

The authors thank LTC Debra Mark and

LTC Mary Hardy, who were responsible for implementation of the Evidence-

Based Practice Training Program at Tripler Army Medical Center, and CAPT Patricia Kelley, without whom we could

not have conducted this project.

The views and opinions expressed in this arti-

cle are solely those of the authors and do not reflect the policy or position of the Department of the Army, the Department

of Defense, or the U.S. Government.

Corresponding author: Edward E. Yackel, MSN, RN, FNP-BC, U.S. Army Nurse

Corps, McDonald Army Health Center, Fort Eustis, VA 23604 (e-mail:

[email protected]).

REFERENCES Badamgarav, E., Weingarten, S. R., Henning, J. M.

Knight, K., Hasselbald, V., Gano, A. Jr., et al.

(2003). Effectiveness of disease management pro- grams in depression: A systematic review. American

Journal of Psychiatry, 160(12), 2080-2090. Bil, D., van Marwijk, H. W., de Haan, M., van Til-

burg, W., & Beekman, A. J. (2004). Effectiveness of

disease management programmes for recognition, di- agnosis and treatment of depression in primary care. European Journal of General Practice, 10(1), 6-12.

Reprinted

with permission.

APPENDIXC & ca

Blair-West, G. W., Mellsop, G. W., & Eyeson-Annan,

M. L. (1997). Down-rating lifetime suicide risk in

major depression. Acta Psychiatrica Scandinavica, 95(3), 259-263.

Centers for Disease Control and Prevention. (2003).

Healthy people 2010: Progress review focus area 18. Retrieved July 5, 2006, from http:/Avww.cdc.gov/ nchs/about/otheract/hpdata2010/focusareas/fa18- mentalhealth.htm

Centers for Disease Control and Prevention. (2007).

Suicide: Facts at a glance. Retrieved July 22, 2007, from http://www.cde.gov/injury

Corson, K., Gerrity, M. S., & Dobscha, S. K. (2004).

Screening for depression and suicidality in a VA pri- mary Care setting: 2 items are better than 1 item. Amer-

ican Journal of Managed Care, 10(11 Pt. 2), 839-845. Dickey, W. C., & Blumberg, S. J. (2002). Prevalence

of mental disorders and contact with mental health professionals among adults in the United States, National Health Interview Survey, 1999. Retrieved July 5, 2006, from http://mentalhealth.samhsa.gov/ publications/allpubs/SMA04-3938/Chapter08.asp

Harris, E. C., & Barraclough, B. (1997). Suicide as

an outcome for mental disorders. A meta-analysis. British Journal of Psychiatry, 170, 205-Y228.

Harris, R. P., Helfan, M., Woolf, S. H., Lohr, K.

N., Mulrow, C. D., Teutsch, S. M., et al. (2001).

Current methods of the US Preventive Services Task Force: A review of the process. American Journal of Preventive Medicine, 20(Suppl. 3), 21-35.

Hirschfeld, R. M., Keller, M. B., Panico, S., Arons,

B. S., Barlow, D., Davidoff, F., et al. (1997). The

National Depressive and Manic-Depressive Associ- ation consensus statement on the undertreatment of

depression. JAMA, 277(4), 333-340.

Hunter, C. L., Hunter, C. M., West, E. T., Kinder, M.

H., & Carroll, D. W. (2002). Recognition of depres-

sive disorders by primary care providers in a military medical setting. Military Medicine, 167(4), 308-311.

Jackson, J. L., O’Malley, P. G., & Kroenke, K. (1999). A

psychometric comparison of military and civilian medi- cal practices. Military Medicine, 164(2), 112-115.

Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine,

16(9), 606-613. Kroenke, K., Spitzer, R. L., & Williams, J. B. (2003).

The Patient Health Questionnaire-2: Validity of a two-item depression screener. Medical Care, 41(11),

1284-1292. Lowe, B., Grafe, K., Zipfel, S., Witte, S., Loerch, B., &

Herzog, W. (2004). Diagnosing ICD-10 depressive

episodes: Superior criterion validity of the Patient Health Questionnaire. Psychotherapy and Psychoso-

matics, 73(6), 386-390.

Luoma, J. B., Martin, C. E., & Pearson, J. L. (2002).

Contact with mental health and primary care providers before suicide: A review of the evidence. American Journal of Psychiatry, 159(6), 909-916.

Reprinted

with permission.

A Nurse-Facilitated Depression Screening Program 257

Neumeyer-Gromen, A., Lampert, T., Stark, K., &

Kallischnigg, G. (2004). Disease management pro- grams for depression: A systematic review and meta-

analysis of randomized controlled trials. Medical Care, 42(12), 1211-1221.

Olfson, M., Weissman, M. M., Leon, A. C., Sheehan,

D. V., & Farber, L. (1996). Suicidal ideation in

primary care. Journal of General Internal Medicine, 11(8), 447-453.

Pignone, M., Gaynes, B. N., Rushton, J. L., Mulrow,

C. D., Orleans, C. T., Whitener, B. L., et al. (2002).

Screening for depression: Systematic evidence review

no. 6. Prepared by the Research Triangle Institute, University of North Carolina Evidence-Based Practice Center under Contract No. 290-97-0011. Rockville, MD: Agency for Healthcare Research and Quality.

Schulberg, H. C., Lee, P. W., Bruce, M. L., Raue, P.

J., Lefever, J. J., Williams, J. W. Jr., et al. (2005). Suicidal ideation and risk levels among primary care patients with uncomplicated depression. Annals of

Family Medicine, 3(6), 523-528.

Simon, G. E., & VonKorff, M. (1995). Recogni-

tion, management and outcomes of depression in primary care. Archives of Family Medicine, 4(2), 99-105.

Sobieraj, M., Williams, J., Marley, J., & Ryan, P.

(1998). The impact of depression on the physical health of family members. British Journal of General

Practice, 48(435), 1653-1655.

Titler, M. G., Kleiber, C., Steelman, V. J., Rakel, B.

A., Budreau, G., Everett, L. Q., et al. (2001). The

Iowa Model of Evidence-Based Practice to Promote Quality Care. Critical Care Nursing Clinics of North America, 13(4), 497-S09.

United States Preventive Services Task Force. (2002).

Screening for depression: Recommendations and rationale. Annals of Internal Medicine, 136(10),

760-764. United States Preventive Services Task Force. (2004).

Screening for suicide risk: Recommendation and

rationale. Annals of Internal Medicine, 140(10),

820-821.

Valenstein, M., Vijan, S., Zeber, J. E., Boehm, K., &

Buttar, A. (2001). The cost-utility of screening for

depression in primary care. Annals of Internal Medi- cine, 134(5), 345-360.

Veterans Administration/Department of Defense. (2002). Management of major depressive disorder (MDD) in adults in the primary care setting, initial assessment and treatment. Retrieved January 25,

2006, from http://oqp.med.va.gov/cpg/cpg.htm Waldrep, D. A., Cozza, S. J., & Chun, R. S. (2004).

XIII. The impact of deployment on the military fam- ily. From the National Center for Post-Traumatic Stress Disorder. Iraq War Clinician Guide. Retrieved August 29, 2006, from http://www.ptsd.va.gov/

professional/manuals/manual-pdf/iweg/iraq_clini- cian_guide_ch_13.pdf

Generating and Assessing Evidence for Nursing Practice (11th ed.)

TRANSLATION AND VALIDATION

OF THE DIETARY APPROACHES TO

SToPp HYPERTENSION FOR KOREANS INTERVENTION Culturally Tailored Dietary Guidelines for Korean

Americans With High Blood Pressure

Hyerang Kim e¢ Hee-Jung Song ¢ Hae-RaHan e Kim B. Kim ¢ Miyong T. Kim

> Background: Lifestyle modification strategies such > Results: A total of 28 KAs with HBP participated in

as adoption of the Dietary Approaches to Stop Hyper- a 10-week dietary intervention consisting of group

tension (DASH) diet are now recognized as an integral education sessions and individual counseling. Both

part of high blood pressure (HBP) management. systolic blood pressure and diastolic blood pres-

Although the high prevalence of HBP among Korean sure, as measured by ambulatory blood pressure

Americans (KAs) is well documented, few dietary in- monitoring, were significantly decreased at postin-

terventions have been implemented in this population, tervention evaluation (systolic blood pressure, —4.5

in part because of a lack of culturally relevant nutrition mm Hg; diastolic blood pressure, —2.6 mm Hg; P

education guidelines. Translating and testing the < .05). Serum low-density lipoprotein cholesterol

efficacy of culturally relevant dietary recommendations was significantly decreased (—7.3 mg/dL; P< .05).

using a well-established dietary guideline such as Serum potassium and ascorbic acid levels were

DASH are imperative for promoting better cardiovas- also improved in the reference range. Urine potas-

cular health for this high-risk cultural group. sium level was significantly increased, supporting

> Objective: \he aims of this study were to system- increased fruit and vegetable consumption.

atically translate and validate a culturally modified > Conclusion: This pilot study has (a) demon-

DASH for Koreans (K-DASH) and obtain preliminary strated that a cultural adaptation of DASH using

evidence of efficacy. community-based participatory research methodol-

b> Methods: A 2-step approach of intervention ogy produced a culturally relevant and efficacious

translation and efficacy testing, together with close dietary intervention for the KAs with HBP and (b)

adherence to principles of community-based partic- provided strong preliminary evidence for the effi-

ipatory research, was used to maximize community cacy of the K-DASH intervention in reducing HBP in

input. A 1-group pre-post design with 24-hour urine hypertensive KAs.

and 24-hour ambulatory blood pressure monitoring > Key Words: CBPR - DASH - hypertension -

comparisons was used to test the initial feasibility Korean American

and efficacy of the K-DASH intervention.

258 Reprinted with permission from Kim, H., Song, H.-J., Han, H.R., Kim, K. B., and Kim, M. T. (2013). Translation and validation of the dietary approaches to stop hypertension for Koreans intervention: Culturally tailored dietary guidelines for Korean Americans with

high blood pressure. Journal of Cardiovascular Nursing, 28(6), 514-523.

Recent empirical studies have revealed an

alarming increase in morbidity and mortal- ity from cardiovascular disease as well as

an increase in relevant risk factors such as high blood pressure (HBP) in Asians living in Western countries, including Korean

Americans (KAs).'° The overall prevalence

of HBP in KAs is higher than that in their white counterparts and is comparable with

that in African Americans.* This phenom-

enon is seemingly paradoxical because

Koreans as a whole are considered a rel- atively lean population, and their tradi-

tional diet has been considered “healthy” in terms of its balance of macronutrients (carbohydrate, protein, and fat).°-'! The level of micronutrients such as potassium, magnesium, and vitamin C in the tradi-

tional Korean diet, however, is not opti-

mally balanced because most of the KAs’ traditional dishes contain highly salted or

cooked vegetables.*!°'? Given that recent

clinical data have highlighted the important role of adequate micronutrient intake in managing HBP,’ finding effective ways to

improve micronutrient intake is an important

endeavor for translational researchers and

clinicians. The most recent guidelines from the

Joint National Committee on Prevention,

Detection, Evaluation, and Treatment of High

Blood Pressure have endorsed the Dietary

Approaches to Stop Hypertension (DASH)

diet for individuals with HBP, in addition to

engagement in other self-care activities, such as adherence to anti-hypertensive medication

regimens, and in regular physical activity. They emphasize increased intake of low-fat dairy products; fish, chicken, and lean meats;

and nuts, fruits, whole grains, vegetables, and

legumes.'* Evidence supporting the efficacy of this diet, from a series of feeding studies as well as studies under free-living condi- tions,'*"!” has indicated that the consumption of a diet that incorporates large quantities of

low-fat dairy products, fruits, and vegetables

and is relatively low in fat content and rich in fiber can produce the greatest reduction in

blood pressure (BP).

Reprinted

with permission.

APPENDIXD # DASH for Koreans 259

The DASH diet has reduced levels of

total fat, saturated fat, and cholesterol and

increased levels of potassium, calcium, mag- nesium, fiber, and protein.

Although ample evidence of the bene-

ficial effect of DASH in improving BP has been obtained through research in well-

controlled settings (eg, feeding studies), a lack of community-based research has

imposed serious barriers to translating and implementing such nonpharmacological

approaches in hypertensive individuals from ethnic minority backgrounds. In particular,

immigrant population consuming bicultural diets, such as KAs, require special attention.

These individuals’ dietary patterns tend to change after their immigration to the United States. In particular, many KAs going

through the acculturation process increase their consumption of animal protein, fats,

and refined sugar.'° At the same time, they

retain the taste for salt to which they were

accustomed and continue to consume tradi-

tional high-salt foods (eg, pickled vegetables as well as soy and other high-sodium sauces). This bicultural diet can be particularly detri- mental to people who have or are at risk for HBP. !8-2°

In response to the high prevalence of HBP

in KA communities and the dietary patterns

that provide these individuals with an inad- equate micronutrient balance,***! we have developed a culturally relevant, micronutrient- enhanced dietary educational and counseling intervention, K-DASH, for KAs with HBP

that is based on the principles of the DASH diet, and we have successfully completed a feasibility trial to evaluate the initial efficacy

of this intervention. The aims of this article were to (a) describe

the process of developing a Korean version of DASH, (b) present the evidence for the

efficacy of this intervention from pilot testing,

and (c) share lessons learned during the devel-

opment of this cultural guideline, to help fill the existing clinical and translational scientific gaps in the area of HBP control and health

promotion guidelines targeting underserved

populations.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

260 APPENDIXD #

# Methods

DESIGN, SETTING, AND SAMPLE

The study describes a 2-step intervention involving translation and efficacy testing that was guided by the core principles of community-based participatory research

(CBPR).?2-*4 Community-based participatory

research has been widely used in public health research as an interdisciplinary research methodology that features a collaborative partnership between researchers and com- munities and focuses on health promotion through lifestyle changes, including uncover- ing barriers to care and self-management and developing culturally tailored interventions and collaborative research processes.*>* The CBPR approach is considered one of the most

effective approaches for translating behav- ioral interventions for priority populations,

including constructing culturally appropriate

programs for ethnic minority groups.*°?”??*!

A centrally located community-based organi- zation in the Baltimore-Washington metropol-

itan area, The Korean Resource Center, was

selected as the education venue for this study.

In this community-based setting, researchers, clinicians, study participants, their family

members, and community health workers

were able to actively engage in multidirec-

tional communication to construct and imple-

ment a culturally relevant education program

while creating synergy in an adapting tailored

dietary modification program to achieve indi-

vidual dietary goals.

In the intervention translation phase, we used a methodology similar to the one we previously used to develop culturally sensi- tive dietary guidelines for KAs with diabetes mellitus.*” This approach follows a step-wise

pattern: (1) identifying the cultural needs of

the target population, (2) evaluating existing

research and evidence, (3) determining the core

principles of the intervention, (4) translating

the core principles into culturally applicable practice, and (5) assessing the content validity

of the translated intervention. By using this

DASH for Korean Americans

systematic process, we developed the initial K-DASH educational guide-lines that encom- pass popular ethnic food items and serving sizes for each food group available to the KA

population residing in the United States.

The content validity and equivalence of the K-DASH were assessed through a series of focus groups composed of bilingual research- ers, clinicians, and KA participants and their family members. The operational principles

of this validity assessment were similar to

those used for instrument testing.***? The

individuals participating in the focus group meetings were asked to assess the cultural

relevance of each educational objective and

strategy. A bicultural research team convened

a final meeting to resolve any discrepancies

that had not been resolved in earlier meetings. These focus groups were useful not only in assessing the content validity of the translated

educational intervention protocol but also

in obtaining important social and cultural information and insights regarding perceived barriers to and strategies for building a

healthy lifestyle for KAs with HBP.

To test the efficacy and feasibility of the K-DASH education intervention, we used a

pre-post intervention evaluation design and a purposive sample of 30 KAs with HBP.

Inclusion criteria were (a) self-identified

KA 21 years or older; (b) HBP (systolic blood

pressure [SBP] => 140 mm Hg and/or dia-

stolic blood pressure [DBP] > 90 mm Hg or

on HBP medication); if on antihypertensive

medication, receiving stable doses for at least

2 months before the beginning of the study; and (c) ability to follow all trial procedures.

We excluded individuals with any of the

following conditions: (a) a cardiovascular event within the past 6 months, (b) a chronic

disease that might interfere with trial partic- ipation (eg, chronic kidney disease, defined

as an estimated glomerular filtration rate <60

mL/min/1.73m”, or poorly controlled diabetes [hemoglobin Alc >9%]), (c) a blood potas-

sium level of 5S mEq/L or higher at screening visit, (d) unwillingness or inability to adopt a

DASH-like diet, and (e) consumption of more

than 14 alcoholic drinks per week.

Reprinted

with permission.

PROCEDURE

After approval had been obtained from the institutional review board, participants

were recruited though advertisements in community newspapers, personal networks,

and referrals from community physician networks in the Baltimore-Washington

metropolitan area. The study was briefly explained by trained research staff, and

individuals were asked if they were interested

in learning more about the program. If the

answer was affirmative, an appointment was scheduled for an eligibility evaluation. After the identification of potential participants, a trained researcher met with each potential participant to explain the purpose of the

study and obtain informed written consent for participation.

The study was conducted from March to August 2011. The participants received two

2-hour nutrition education sessions at 2 and 3 weeks and 4 individual nutrition counseling

sessions with a bilingual dietician at a local community center over the course of the 10- week intervention period. Participants were

asked to attend in-person follow-up visits at

4 and 10 weeks after baseline. At in-person follow-up visits, anthropometry (body weight,

height, and waist-to-hip ratio), biochemistry evaluation (fasting blood test and 24-hour

urine analysis), 24-hour ambulatory BP monitoring (ABPM), and dietary assessment

using a 3-day dietary record were conducted

to evaluate the effectiveness of the nutrition

education and counseling.

DESCRIPTION OF THE DIETARY APPROACH TO STOP HYPERTENSION FOR KOREANS

The K-DASH was guided by the original DASH eating plan and was expanded by incorporating culturally familiar dietary

concepts and traditional food examples.

Developing a culturally relevant dietary guide-

line for KAs involved examining the relevance

and accept-ability of the existing dietary

guidelines, the DASH eating plan (established

Reprinted

with permission.

APPENDIXD #® DASH for Koreans 261

by the National Heart, Lung, and Blood

Institute) and The Korean Nutrition Society

meal plan (Table 1). A comparison of the sim- ilarities and differences between these guide-

lines was helpful in identifying key aspects that needed to be translated, so that an

effective and culturally relevant nutrition edu- cation program could be developed for our target population. The process of developing culturally relevant strategies for delivering the

core DASH principles and relevant examples are illustrated in Table 1. The key differences in these guidelines included the macronutrient

distribution, the number of servings of some

food groups, and the recommendations for fat intake.

The 10-week K-DASH intervention

consisted of 2 structured in-class education sessions with interactive group activities, 3

individually tailored nutrition consultations

with a bilingual nurse/dietician team, and 1

follow-up telephone call (Table 2).

Structured Group Education. Once-weekly

2-hour structured group education sessions were held for 2 weeks to provide the partic- ipants with a fundamental overview of what

constitutes a healthy diet; an introduction to the K-DASH diet (particularly emphasizing

the importance of increased fruit and fresh vegetable consumption and a reduction in sodium intake from the traditional Korean diet); the basic concepts of calorie balance,

serving size, and food label content; and strat-

egies to consume the desirable amount of each

micronutrient were presented. Culture-specific food models consisting of 78 life-size models

of frequently consumed Korean foods were used to enhance the sessions’ educational

effectiveness. In addition, interactive group

activities were conducted in various formats,

including culturally tailored group games, pop

quizzes, recipe sharing, and demonstrations

of meal plans. In particular, the best practices

to reduce sodium intake when eating out and to increase fruit and vegetable consumption

in the daily diet were shared and extensively

discussed as a group. The group education was delivered in a community-based setting to

Generating and Assessing Evidence for Nursing Practice (11th ed.)

262 APPENDIXD & DASH for Korean Americans

Table 1 Development of Culturally Relevant Strategies for Delivering Education

Content Through Nutrition Education Programs by Translating Existing Dietary

Guidelines

Category DASH KDA/KNS

Measurement Basedoncupand Base on gram units

unit of 1 ounce units

serving

Concept of All food in the Two subcategories

serving size grain group in the grain group:

in the grain (1 serving = about staple foods

group 100 kcal) (1 serving = 300 kcal)

and side dishes (1

serving = 100 kcal)

Number of More servings of More servings

servings fruits and dairy of grains and

vegetables

Food Targeted to Targeted to Koreans

examples the general in Korea

American

population

Consists of traditional

Korean foods to

address the dietary

pattern of Koreans

Consists of a

majority of

foods frequently

consumed by

Americans

in the United

States

Examples of Culturally Relevant Strategies

Culturally familiar units of

measure (Cups, ounces,

and grams) were used

to explain the serving

size of each food item

based on the individual’s

understanding.

To make it easy to count the

daily total serving size,

1 serving of grain was

standardized to 100 kcal,

regardless of the food item.

To reflect the traditional

vegetable-centered

dietary pattern of KA, a

total number of servings

of fruits and vegetables

was suggested in place

of respective servings of

fruits and vegetables, while

the fundamental frame of

the DASH guidelines was

maintained.

Based on the framework

of the DASH guideline,

adopting culturally familiar

nutritional concepts and

traditional Korean food

examples from the KNS.

Taking into consideration the

acculturated dietary status

of KAs, the food example

list was expanded by

including both traditional

Korean food and American

food items available for or

frequently used by KAs.

Generating and Assessing Evidence for Nursing Practice (11th ed.) Reprinted

with permission.

APPENDIXD #® DASH for Koreans 263 ~

Table 1 (continued) po a aa tra a ee ah bi eatin eet tere Category DASH KDA/KNS Examples of Culturally

Relevant Strategies

Beans and Not specified,

bean but generally

Beans and bean

products are

Making use of culturally

familiar nutrition concepts

products beans and peas considered part (beans and bean products

are considered of protein foods are very familiar food items

part of both the group, which as protein sources for

protein foods includes meat, Koreans), beans and bean

group and poultry, and fish. products were considered

the vegetable part of meat, poultry, and

group. fish group, and KAs were

encouraged to use this

plant protein source as an

alternative to red meat.

Meal Counting of Counting of serving Integrating meal planning

planning serving sizes sizes according to methods to introduce basic

according to

the individual’s

level of calorie

intake using

food groups

the individual’s

level of calorie

intake using a food

pyramid

nutrition information and

meet the educational needs

of the target population;

a culturally tailored food

pyramid was used for

fundamental nutrition

information; calorie and

nutrient counting skills

were taught as part of

interpreting nutrition facts

on food labels.

Abbreviations: DASH, Dietary Approach to Stop Hypertension; KDA, Korean Dietetic Association; KNS, Korean

Nutrition Society.

actively promote interaction among the study

participants, family members, community

health workers, and educators while creating synergy and providing social support to the KAs in achieving their individual nutrition

goals.

INDIVIDUAL COUNSELING

After the weekly 2-hour structured group education sessions, the nurse/dietician team

met one-on-one with each patient at 4, 5, and 10 weeks (for 30-60 minutes per visit).

Individual counseling was conducted to help

Reprinted

with permission.

individuals develop customized dietary goals and meal plans, reinforce the K-DASH recom-

mendation at the individual level, and discuss

individual barriers and facilitators to adhering to the diet regimen. Individual counseling (3

in-person sessions and 1 telephone session) was devoted to meeting the individual’s nutritional needs, based on (a) daily caloric

intake, calculated on the basis of gender, height, weight, and physical activity level, and (b) individual dietary analysis of information

from multiple 24-hour recalls at baseline and follow-up. In particular, dietary analysis

results based on a 3-day dietary record at each follow-up were used during counseling

Generating and Assessing Evidence for Nursing Practice (11th ed.)

264 APPENDIXD @ DASH for Korean Americans

Table 2 The Dietary Approach To Stop Hypertension for Koreans Intervention

Week Contents

Week 1 (2 h) Structured group education |

Overview of a fundamentally healthy diet

Introduction to the K-DASH diet

Calorie balance, serving vs portion size

Week 2 (2 h) Structured group education Il

Introduction of strategies to consume the desirable amount of

each micronutrient

Reading food labels

Identifying barriers to and facilitators of a healthy diet

Week 4 (0.5-1 h) Individualized nutrition consultation

Developing an individual meal plan

Planning meals, shopping, healthier cooking

Week 5 (0.5-1 h) Individualized nutrition consultation

Reinforcing nutrition-related knowledge

Individual practice in interpreting food labels

Individual barriers to and facilitators of following K-DASH

Week 8 (0.5 h)

Week 10 (0.5-1 h)

Follow-up telephone call

Individualized nutrition consultation for long-term sustainability

Preparing for a transition to independence

Maintenance strategies and relapse prevention

Abbreviation: K-DASH, Dietary Approach to Stop Hypertension for Koreans.

to reinforce the effects of the nutrition educa- tion and to facilitate adherence to individual dietary goals.

Individualized dietary recommendations were specifically tailored to the participant’s

caloric needs, dietary preferences, lifestyle

context, and acculturation level. For example, less acculturated KAs whose dietary pattern

was similar to that of Koreans in Korea were

advised to reduce the normally high sodium intake caused by consuming traditional Korean foods, including soybean paste—

based soup, kimchi, and salted pickles; more

acculturated KAs were advised to reduce their

intake of processed food, which is a major

dietary source of sodium in the United States.

At week 10, the last nutrition consultation

was held to support the maintenance phase as the participants prepared for the transition

to independence in sustaining their individual

dietary strategies. Appropriate meal planning

and healthy food selection were reinforced,

Generating and Assessing Evidence for Nursing Practice (11th ed.)

and challenging situations (eg, eating out or

socializing) were addressed. As an additional reinforcement strategy to ensure adherence to

the diet regimen, a brief follow-up telephone call was made at 8 weeks.

MEASUREMENT

Fasting blood tests were conducted at baseline and at 4 and 10 weeks to examine the time

course of any changes in serum lipid profile and as a safety check for hyperkalemia. A 24- hour urine test was conducted at baseline and again at 10 weeks to assess compliance with

the dietary modification (proper instruction was given for obtaining a complete 24-hour urine collection).

Ambulatory BP monitoring (Space Labs,

Redmond, Washington) 24-hour recordings were obtained at baseline (end of run-in, week

0) and at 10 weeks after the intervention.

Reprinted

with permission.

Blood pressure readings were recorded every

30 minutes between 7:00 AM and 11:00 PM and hourly between 11:30 PM and 7:30 AM.

Daytime BP was reported as the average of

BPs measured between 6:30 AM and 11:30 PM, and nighttime BP was the average of measurements between 11:30 PM and 6:30 AM. Participants who worked night shifts or had irregular evening shifts were excluded

from the daytime and nighttime analyses but

were included in the 24-hour overall BP anal-

yses. Daytime ambulatory SBP, as determined

by 24-hour ABPM, was the primary outcome measure, with average 24-hour and nighttime BP as secondary measures.

To assess the level of adherence to the K-DASH education guideline, a 3-day dietary

record was obtained at each time of data collection. The participants were carefully

instructed about how to record the amounts of foods and snacks ingested, as assessed

using household measures, and they were

instructed on how to determine the capacity

of the utensils before they began recording.

The food items and amounts of food con- sumed as indicated in the diet records were

verified by the same person using food mod- els. An experienced clinical dietician reviewed and analyzed all diet records and provided individually tailored feedback to the partici- pants in individual counseling.

All diet records were analyzed using

the Computer-Aided Nutritional Analysis program version 3.0 (The Korean Nutrition

Society, Korea) for the traditional Korean

food items and the food composition data- bases from the US Department of Agriculture

for the Western food items.

STATISTICAL ANALYSES

Descriptive statistics were used to summa-

rize sample characteristics and to compare differences in primary and secondary out-

comes at 10 weeks. Continuous variables

were presented as mean (SD), and discrete

variables, as n (%). Differences in biochem-

ical analysis between baseline and each data

Reprinted

with permission.

APPENDIXD @ DASH for Koreans 265

collection time (at 4 and 10 weeks) were

assessed by repeated-measures analysis of variance. Changes in BP from baseline to

week 10 of the intervention were assessed by paired f tests. All statistical analysis was performed using IBM SPSS version 19 (SPSS

Inc, Chicago, Illinois). Statistical significance

was determined at « = .05.

H# Results

PARTICIPANT CHARACTERISTICS

A total of 30 KA volunteers with HBP were

recruited for the study. Of the 30 recruited,

28 KAs with HBP (16 men, 12 women) com-

pleted the 10-week intervention that consisted of 2 group education sessions and 4 individ-

ual counseling sessions (Table 3). The mean

(SD) age of the study participants was 55.3 (6.8) years, and the mean (SD) length of stay

in the United States was 18.5 (9.8) years. The

mean (SD) duration of the HBP diagnosis in

this group was 5.7 (5.8) years, and 21 (75%)

of the study participants were on HBP medi- cation(s) and had not changed their medica-

tion dose during the intervention period.

BLOOD PRESSURE OUTCOMES

Descriptive statistics yielded a mean (SD) baseline SBP and DBP of 144.4 (10.0) and

88.0 (8.4) mm Hg, respectively. Our pri-

mary outcomes, daytime ambulatory SBPs

and DBPs as measured by ABPM, were both statistically and clinically significantly

decreased at the 10-week postintervention

evaluation (SBP, —4.5 mm Hg; DBP, —2.5

mm Hg). The 24-hour ABPM revealed a small

but significant decrease in 24-hour overall SBP (133.0 [10.2] vs 129.2. [9:7].mm Hg; P= .004) and DBP (83.8 [6.7] vs 81.8 [7.2] mm Hg; P = .010) after 10 weeks of intervention.

Although there were no statistically signifi-

cant changes in nighttime SBP or DBP, the

decreases in SBP (136.1 [11.2] to

Generating and Assessing Evidence for Nursing Practice (11th ed.)

266 APPENDIXD

Table 3 General Characteristics

Variables Total (n = 28)

Age, mean (SD), y 55.3 (6.8)

Gender, n (%)

Male 16 (55.2)

Female 12 (41.4)

Years of education, 14.4 (4.2)

mean (SD)

Marital status, n (%)

Married 26 (89.7)

Divorced 1 (3.4)

Partnered 1(3:4)\.

Length of stay inthe United 18.5 (9.8)

States, mean (SD), y

Employment, n (%) Working full-time 18 (62.1)

Working part-time 5 (17.2)

Unemployed 1 (3.4)

Housekeeper 4 (13.8)

Insurance, yes, n (%)* 11 (37.9)

Medicaid =

Medicare 2 (6.9)

Private 9 (31.0)

HBP duration, mean 5.7 (5.8)

(SD), y On antihypertensive 21 (75.0)

medication, n (%)

Medication duration, 4.8 (4.8)

mean (SD), y

Abbreviation: HBP, high blood pressure. “Multiple-response question.

131.6 [10.8] mm Hg; P = .002) and DBP (86.0 [6.9] to 83.5 [7.8] mm Hg; P = .003) during the daytime were significant (Figure 1).

BIOCHEMISTRY PARAMETERS

At baseline, many participants were found to

be consuming less than 75% of the recom-

mended levels of micronutrients; at least 50%

of the participants consumed less than 75%

of the recommended intake of fiber (14/28,

50%), vitamin C (13/28, 50%), folate (16/28, 60%), calcium (24/28, 90%), and potassium

(16/28, 60%) (data not shown).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

DASH for Korean Americans

140 — eee Seeeste * @ O week

TRA Ogee i mi 10 weeks 130 4- Be a

125 + ee

120 4 ee

115

110

SBP overall SBP daytime SBP nighttime

— @ O week 85 | f}—

| a @ 10 weeks

DBP overall DBP daytime DBP nighttime

Figure 1. Changes in blood pressure, as measured

by 24-hour ambulatory blood pressure monitoring

(ABPM), from baseline to 10 weeks of intervention.

A, systolic blood pressure (SBP) change. B, diastolic

blood pressure (DBP) change. The statistical signif-

icance of changes between baseline and 10 weeks

was assessed by paired ttest. *P< .05; **P<.01.

Dietary intake analysis after 10 weeks of intervention revealed a reduction in calories

(-131.8 kcal/d), sodium (—169 mg/d), and

cholesterol (-171.2 mg/d). The consumption

of all targeted micronutrients was slightly enhanced but not significant except for calcium (potassium, 236 mg/d; vitamin C, 11.1 mg/d; calcium, 152 mg/d [P < .05]; and

dietary fiber, 4.8 g/d).

The results from both urine and blood

tests revealed similar results: As compared with baseline, at week 10 of the intervention,

serum low-density lipoprotein cholesterol lev-

els were significantly decreased (124.2 [19.9]

to 116.9 [25.2] mg/dL; P = .047), and both

potassium (4.0 [0.3] to 4.2 [0.4] mEq/L;

P = .040) and ascorbic acid (0.6 [0.3] to 0.8

Reprinted

with permission.

APPENDIXD #® DASH for Koreans 267 ~~

Table 4 Changes in Biochemistry Parameters (n = 28) PE ES ES Sk ESRI AE RPS WD es ES a

Reference 0 wk 4wk 10 wk P

Total cholesterol, 130-200 205.8 (22.2) 197.6 (24.5) 200.4 (24.6) .056 mg/dL?

HDL-cholesterol, Men: 30-65 54.4 (14.8) SPO 14a7)) 51.3 (16.5) .034

mg/dL Women: 38-73

LDL-cholesterol, <130 124.2 (19.9) 115.4 (25.0) 116.9 (25.2) .047

mg/dL

Triglyceride, mg/dL 34-143 167.3 (134.6) 180.4(143.2) 175.0(101.8) .661

Na, mEq/L 135-148 140.6 (1.9) 140.4 (2.0) 140.2 (1.8) .688

K, mEq/L 3.5-5.1 4.0 (0.3) 4.0 (0.3) 4.2 (0.4) .040

Ca, mEq/dL 8.4-10.5 9.3 (0.3) 9.3 (0.3) 9.3 (0.3) 556

Ascorbic acid, mg/dL 0.2-1.9 0.6 (0.3) 0.7 (0.3) 0.8 (0.3) .008

Urine Na, mEq/L® 15-237 155.7 (63.5) - 162.4 (51.5) .697

Urine P, mEq/L 22-164 63.9 (30.5) - 78.1 (26.6) .025

Urine Mg, mEq/L 0.4-15.0 7.5 (2.3) - Sin(257) .388

Abbreviations: HDL, high-density lipoprotein; KA, Korean American; LDL, low-density lipoprotein. Data are presented as mean (SD).

“The significances of changes in blood chemistry outcomes from baseline to 10 weeks of intervention were examined

by repeated-measures analysis of variance. >The significances of changes in urine analysis between baseline and 10 weeks were examined by paired t test.

[0.3] mg/dL; P = .008) levels were signifi-

cantly increased to the reference range (Table 4). Urine phosphate excretion was also signifi-

cantly increased (63.9 [30.5] to 78.1 [26.6]

mEq/L; P = .025).

@ Process Evaluation

Because this study represented the first pilot

testing of a micronutrient-related educational

intervention for a KA sample, we conducted a

systematic process evaluation of the interven- tion. In general, participants were satisfied

with the content of the education. The educa-

tional intervention was the first opportunity they had had to participate in a culturally relevant dietary education and counseling pro- cess. Although most of the participants were

also satisfied with the other components of

the intervention process (the time allocations

of the educational classes and counseling, the intervener characteristics, and the educational

Reprinted with permission.

facility), the research team concluded that a

thoughtful integration of the qualitative data for this intervention (particularly the intensity

and dose of the intervention) with an in-depth analysis of data from a larger sample is war- ranted before definitive recommendations can

be made to clinicians in the field.

= Discussion

This study has demonstrated that a CBPR

framework-guided, systematic translational adaptation of a well-established dietary guide-

line can be a useful approach to producing a culturally relevant nutrition education

program for an ethnic minority group with culturally distinct dietary patterns. The results

of this study also suggest that the K-DASH, a community-based, culturally tailored nutri-

tion intervention for KAs, is efficacious in

improving HBP control in a sample of KA

immigrants with HBP.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

268 APPENDIXD #

Our important findings can shed light on

several areas of HBP intervention: First, the

positive outcomes of this study reinforce the important role of micronutrients in HBP con- trol; in particular, our results have the poten-

tial to fill significant knowledge gaps in the literature regarding the role of micronutrients in controlling HBP. Although a large body of

evidence exists concerning the effects of dietary interventions, including antioxidant and min-

eral supplementation, on BP and cardiovascular

disease outcomes, many of the relevant studies

have suffered from systematic measurement errors that may explain the inconsistencies

that have been observed across trials in terms

of BP outcome.**” The present study was

designed to provide the empirical data needed

to evaluate the potential use of a micronutrient-

enhanced diet in reducing health disparity gaps

related to HBP control in minority groups such

as KAs who have a high prevalence of HBP and

cultural dietary patterns associated with poor

micronutrient balance. Specifically, we believe

that this study has optimized the characteriza- tion of the main outcomes (SBP and DBP) by

using ABPMs. It is well recognized in the field of BP measurement that ABPM use consider-

ably reduces measurement variability and pro-

duces a BP variance that is equivalent to that

obtained by 5 days of BP measurement with a standard digital device.*?

In addition, the findings of this study provide clues for understanding why certain

groups such as KAs are more vulnerable to HBP despite their normal body weight.

Although not entirely conclusive, the available

evidence indicates that the mechanisms by which unhealthy dietary consumption patterns

lead to HBP are related, in part, to deficiencies

in micronutrients (eg, potassium, magnesium,

and vitamin C).***° Nevertheless, the indepen-

dent effects of micronutrients on BP control have not been well investigated in traditionally lean populations whose HBP prevalence is

unusually high, such as KAs. Although our

study sample was small, our results also con-

firmed that the typical dietary pattern of this group is characterized by a seriously insuffi-

cient intake of micronutrients, especially fiber,

Generating and Assessing Evidence for Nursing Practice (11th ed.)

DASH for Korean Americans

vitamin C, folate, calcium, and potassium.

Although the traditional dietary pattern of KAs

is generally grain based, with a relatively small amount of animal fat, it is also clear that their

consumption of fruits, fresh vegetables, and dairy products is very low, and their sodium intake is extremely high. It seems that these culturally embedded dietary habits may be responsible for the high prevalence of HBP in

this population. In general, serum potassium level is insen-

sitive to changes in dietary intake, and potas-

sium homeostasis is tightly maintained.*°*®

The present study findings, however, pre- sented that change in dietary potassium intake results in increased serum potassium

level in the reference range. Although further investigation is needed, this suggests that a

micronutrient-enhanced diet might be more

effective in controlling HBP in the sodium-

sensitive subgroup. Another unique contribution of this study

in the field of nonpharmacological interven- tions for HBP is that ours is one of the very first translational studies of the DASH inter-

vention in a community setting; most DASH

trials have been conducted in well-controlled metabolic study settings (ie, feeding studies). Our pilot study was designed to implement the K-DASH adaptation in a community

setting, thus improving its external validity (especially ecological validity) and its transla-

tional effectiveness in noncontrolled settings.

Not surprisingly, the BP change (eg, SBP, -4.5

mm Hg) produced by our study was much

more moderate than the BP changes (eg, SBP, —11.4 and -11.5 mm Hg) produced by the previously published, highly controlled DASH feeding studies.'”*” In the future, transla- tional researchers need to pay attention to the

strength of this type of intervention and par- ticularly its intensity in community settings: The appropriate frequency and duration of

this type of intervention for producing optimal outcomes, including the appropriate time for administering 1 or more booster interventions,

also need to be discussed among researchers. The inherent limitations of a small-scale

pilot study such as ours prevent us from

Reprinted

with permission.

-—

making strong inferences from our findings: Because this study was a 1-group, nonran- domized design with a relatively small sam- ple, the findings could have been influenced

by as yet unidentified biases. Future studies should be conducted to cross-validate the findings of this study by means of full-scale

randomized, community-based effectiveness trials. In addition, because of the relatively

short follow-up period (10 weeks), the long- term efficacy of this type of intervention is unknown. Future research with larger sample

sizes and longer follow-up periods is there- fore warranted.

Despite these potential limitations, the present study plays an important role in filling both clinical and translational meth- odological gaps in the areas of HBP control and health promotion guidelines targeting underserved populations. In particular, we hope that by articulating a systematic inter- vention translation process, we will stimulate

methodological discussions among interven- tion researchers focused on health disparity

populations. To summarize, the aim of this study

was to evaluate the efficacy of a culturally tailored dietary modification program, validating a newly translated intervention (culturally tailored DASH for KAs). To determine the efficacy of this intervention, daytime ABPM was used as primary outcome

measure. The magnitude of the changes in

daytime SBP (-4.5 mm Hg) and daytime

DBP (-2.5 mm Hg), as measured by 24-

hour ABPM, demonstrated statistically and

clinically significant decreases because of the

10-week intervention. Despite overwhelming

evidence for the effectiveness of pharmaco- logical interventions in reducing BP, many people with HBP intentionally delay or avoid

pharmacological treatment for their condi- tion.7!5°5! Certain cultural groups such as KAs prefer dietary changes or supplements to pharmacological therapy for the treat- ment of hypertension.°**? Demonstrating the effectiveness of such nonpharmacological approaches is an important area of interven-

tion research. Considering the inexpensive

Reprinted

with permission.

APPENDIXD ® DASH for Koreans 269

and empowering nature of self-care strategies

such as the DASH approach, more rigor-

ous efforts should be made to translate and evaluate these guidelines in a manner that is

culturally meaningful for specific clinical or

ethnic communities, with the ultimate goal of promoting better cardiovascular health in all Americans.

What's New and Important

e This is one of the very first translational

studies of the Dietary Approaches to Stop

Hypertension (DASH) intervention in a com-

munity setting; most of the previous DASH

trials have been conducted in well-controlled

metabolic study settings.

e This study is also the first study of a dietary

intervention conducted in a sample of

Korean Americans (KAs) with high blood

pressure (HBP), a high-risk group that expe-

riences both a high prevalence of HBP and

suboptimal dietary patterns for managing

HBP: a low micronutrient and high sodium

content.

e This article addresses methodological

aspects of the currently underdocumented

health disparity research, presenting a

systematic way to translate evidence-based

behavioral or educational interventions to

suit the needs of an ethnic minority group

with distinctly different cultural contexts for

the target behaviors.

e Although this is the report of small-scale

pilot study, the findings of this study will

stimulate scientific dialogue among inter-

vention researchers, particularly researchers

and clinicians who are exploring the ways

to find a translatable, inexpensive, and safe

approach to managing HBP in KAs and simi-

lar cultural groups that share related dietary

patterns.

Hyerang Kim, PhD Postdoctoral Fellow, School of

Nursing, Johns Hopkins University, Baltimore,

Maryland. Hee-Jung Song, PhD Assistant Scientist, School of

Nursing, Johns Hopkins University, Baltimore,

Maryland.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

7, ew

270 APPENDIXD @

Hae-Ra Han, PhD, RN, FAAN Associate Professor,

School of Nursing, Johns Hopkins University, Baltimore, Maryland.

Kim B. Kim, PhD CEO/President, Korean Resource

Center, Ellicott City, Maryland. Mivong T. Kim, PhD, RN, FAAN Professor, School

of Nursing, Bloomberg School of Public Health,

and School of Medicine, Johns Hopkins Univer- sity, Baltimore, Maryland,

Editorial support was provided by Dr Deborah McClellan through the Johns Hopkins University School of Nursing

Center for Excellence for Cardioyascular Health in Vulnerable Populations (P30

NRO11409).

This publication was made possible by grant

no. ULI RR 025005 from the National Center for Research Resources (NCRR),

a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely

the responsibility of the authors and do not necessarily represent the official view

of NCRR or NIH. The authors have no conflicts of interest to

disclose.

Correspondence: Miyong T. Kim, PhD, RN,

FAAN, School of Nursing, Johns Hopkins University, S25 North Wolfe St, Baltimore, MD 21205-2110 ([email protected]).

DOI: 10.1097/]CN.06013e318262c0c1

REFERENCES

10.

DASH for Korean Americans

. Kwon JH, Shim JE, Park MK, Paik HY. Evalua-

tion of fruits and vegetables intake for prevention of chronic disease in Korean adults aged 30 years and over: using the Third Korea National Health and Nutrition Examination Survey (RNHANES

Ill) 2005. Ker J Nutr. 2009342(2):146-157. . Kim MT, Measuring depression in Korean Americans: development of the Kim Depression Seale for Korean Americans. ] Transcult Nurs. 2002313(2):110-118.

Park SY, Murphy SP, Sharma S, Kolonel LN. Dietary intakes and health-related behaviours of Korean American women born in the USA and Korea: the multiethnic cohort study. Public Health Nutr. 2005;8(7):904-9 11,

. Lee YH, Lee JE, Kim MT, Han HR. In-depth assessment of the nutritional status of Korean American elderly. Geriatr Nurs, 2009;30(3): 304-311. Bae YJ, Kim.MH, Choi MR. Analysis of mag- nesium contents in commonly consumed foods and evaluation of its daily intake in Korean independent-living subjects. Biol Trace Elem Res. 20093135( 1-3): 182-199, Kim MJ, Lee SJ, Ahn YH, Bowen P, Lee H. Di-

etary acculturation and diet quality of hypertensive Korean Americans. ] Adv Nurs. 2007;58(5):

4360-445. Korea Centers for Disease Control and Prevention. In-depth analysis on the 3rd (2005) Korea Health and Nutrition Examination Survey-Nutrition

Survey. 2007. http://acdm.or.kr/htny/statistics/ cd-c/ %B 1% BI %BI%CE%MBO%C viaenitge AD% EEX BS %MBEMETCL%BE%NBBMET%2C

20% C1%AG3 %MBIL%E2(2005 2 — BL BI%MBI%CE%MBO% CT %MBO%AD % BPO BS 99 BESO ET % C1 BEM BBGET %20% CLASS BL%EZ% 20% C1 GBS °%BB% E7%OBO%ME L%BO%MFA%20% BD %C9% C3%FE%BA% DD % BOM AE % 20% BE% ACBL BS %20%2ON%BO%MCT%BO%MAD % BS%MEMOCL%A2%M2ON%MBI2GD7%2O°%BA BS% BO%C7%CD% CF %MBD %C4% 20% BA%

1. Chiu M, Austin PC, Manuel DG, Tu JV. Com- CE%B9%AE_2007045 19. pdf. Accessed parison of cardiovascular risk profiles among January 2012. ethnic groups using population health surveys 12, Kim MJ, Lee Sh. Ahn YH, Lee H. Lifestyle advice between 1996 and 2007. CMAJ. 2010;182(8): for Korean Americans and native Koreans with E301-E310. hypertension, ] Adv Nurs. 2010367(3):53 1-539.

2. Ryan C, Shaw RE. Perspectives on the crisis and 13. Shay CM, Stamler J, Dyer AR, et al. Nutrient and challenge of cardiovascular disease in the diverse food intakes of middle-aged adults at low risk of Asian populations of California. Hawaii Med J. cardiovascular disease: the International Study 2010;69(5 suppl 2):25-27,. of Macro-/Micronutrients and Blood Pressure

3. National Institutes of Health. Addressing Cardio- (INTERMAP) [published online ahead of print vascular Health in Asian Americans and Pacific November 6, 2011). Eur ] Nutr. Islanders: A Background Report. Washington, DC: 14. Sacks FM, Obarzanek E, Windhauser MM, et al. NTH; 2000. NTH publication no. 00-3647. Rationale and design of the Dietary Approaches

4. Kim MT, Kim KB, Juon HS, Hill MN, Prevalence to Stop Hypertension trial (DASH). A multicenter and factors associated with high blood pressure controlled-feeding study of dietary patterns to in Korean Americans. Eth Dis. 2000;10(3): lower blood pressure. Ann Epidemiol. 1995; 364-374. 5(2): 108-118

At ee

15,

16.

YE,

14,

20.

ZY,

DE,

Ze;

25.

26.

Di.

24.

Reprinted with permission.

Champagne CM, Dietary interventions on blood pressure: the Dietary Approaches to Stop Hyperten- sion (DASH) trials, Nutr Rev. 2006;64(2):553-S56. Moore LL, Singer Mi, Bradlee ML, et a). Intake of fruits, vegetables, and dairy products in carly childbood and subsequent blood pressure change. Epidemiology, 2005161 ):4-11. Moore TJ, Conlin PR, Ard J, Svetkey LP. DASH (Dietary Approaches to Stop Aypertension) diet is fective treatment for stage 1 isolated systolic hypertension. Hypertension. 2001 ;38(2):1 55-154. Klatsky AL, Vekawa IS, Armstrong MA. Cardio- vascular risk factors among Asian Americans. Public Health Rep. 199611 S suppl 2):62-64. Tamir A, Cachola S. Hypertension and other car- diovascular risk factor. In: Zane N, Takeuchi D, Young K, eds. Confronting Critical Health Issues of Asian Pacific Islander Americans. Shousand Oaks, CA: Sages Publication; 1994:209-247. Stavig GR, Igra A, Leonard AR. Hypertension and related health sssues among Asians and Pacific Islanders in California. Public Health Rep. 1983;103(1):28-37, Kim MT, Juon HS, Hill MN, Post W, Kim KB. Cardiovaxular disease risk factors in Korean American elderly. West { Nurs Res. 2001;23(3):

269-282, Ivey SL, Patel S, Kalra P, Greenlund K, Srinivasan S, Grewal, D. Cardiovaxular health among Asian Indians: a community research project. J Interprof Care. 2004;18:391-402. Israel BA, Schulz AJ, Parker EA, Becker AB. Community-campus partnership for health. Community-based participatory research: policy recommendations for promoting a partnership approach in health research. Educ Health. 2001;14(2):182-197.

. Kim $, Koniak-Griffin D, Flaskerund JH, Guarnero PA. The impact of Jay health advisors on cardiovascular health promotion. J Cardiovasc Nurs. 2004;19:192-199. Wallerstein NB, Duran B. Using community-based participatory research to address health disparities. Health Promot Pract. 2006;7(3):312-323. Pazoki R, Nabipour J, Seyednezami N, Imami SR. Effects of a community-based healthy heart program on increasing healthy women’s physical activity: a

randomized controlled trial guided by community-

based participatory research. BMC Public Health.

2007;23:216-223. Connell P, Wolfe C, McKevitt C. Preventing

stroke: a narrative review of community inter-

ventions for improving hypertension control

in black adults. Health Soc Care Community.

2008;16:165-187.

Shalowitz MU, Isacco A, Barquin N, et al.

Community-based participatory research: a review of

the literature with strategies for community engage-

ment. | Dev Behav Pediatr. 2009;30(4):350-361.

APPENDIXD ss

Ho,

De:

po:

oS2

36.

37.

38.

oo;

49. —

41.

DASH for Koreans 271

Brownstein JN, Bone LR, Dennison CR, Hill MN, Kim MT, Levine DM, Community health workers 2s interventionists in the prevention and control of heart disease and stroke. Am J Prev Med. QOOS;29:128-433, Kim M, Han H, Kin KB, et al. 15-Month blood pressure outcomes of 2 behavioral intervention using 2 CEPR approach in Korean immigrants. Circulation. LOOT A16:S-387. Abstract. Vollmer WM, Appel LJ, Svetkey LP, et al. DASH Collaborative Research Group. Comparing office- based and ambulatory blood pressure monitoring in clinical trials. { Hum Hypertens. 2005141): 77-62.

Song HJ, Han HR, Lee JE, et al. Translating current dietary guidelines into 2 culturally tailored nutrition education program for Korean American immigrants with type 2 diabetes. Diabetes Educ. 2010;36(5):7 52-761. Boutin-Foster C, Ravenell JE, Greenfield VW, Medmim b, Ogedeghe G. Applying qualitative methods in developing a culturally tailored work- book for black patients with hypertension. Paticnt Educ Couns. 1009;77(1):144-147.

. Jee SH, Miller ER 3rd, Guallar E, Singh VK, Appel LJ, Klag MJ. The effect of magnesium supple- mentation on blood pressure: 2 meta-analysis of randomized dinical trials. Am | Hypertens. 2002;1 5(8):691-696. McRae MP. Is vitamin C an effective antihyper- tensive supplement? A review and analysis of the literature. J Chiropr Med. 2006;5(2)-60-64. Cappuccio FP, MacGregor GA. Does potas- sium supplementation Jower blood pressure? A meta-analysis of published trials. J Hypertens. 1991;9(5):465-473. Brancati FL, Appel LJ, Seidler AJ, Whelton PK. Effect of potassium supplementation on blood pressure in African Americans on a low-potassium diet. A randomized, double-blind, placebo- controlled trial. Arch Intern Med. 1996;156(1):

61-67. Naismith DJ, Braschi A. The effect of low-dose potassium supplementation on blood pressure in apparently healthy volunteers. Br J Nutr. 2003;90(1):53-60. Block G, Jensen, CD, Norkus EP, Hudes M, Craw-

ford, PB. Vitamin C in plasma is inversely related to blood pressure and change in blood pressure during the previous year in young black and white women. Nutr J. 2008;7(1):35. Shafi T, Appel LJ, Miller ER 3rd, Kiag MJ, Parekh RS. Changes in serum potassium mediate thiazide-induced diabetes. Hypertension. 200%; 5§2(6):1022-1029. Cutler JA, Roccella EJ. Salt reduction for pre- venting hypertension and cardiovascular disease: a population approach should include children. Hypertension. 2006;48(5):313-819.

af Generating and Assessing Evidence for Nursing Practice (11th ed.)

tee Se) ee ee re

272 APPENDIXD #

42:

43.

44,

45.

46.

47.

Huang HY, Appel LJ, Croft KD, Miller ER 3rd, Mori TA, Puddey IB. Effects of vitamin C and vitamin E on in vivo lipid peroxidation: results of a randomized controlled trial. Am J Clin Nutr. 2002;76(3):549-555. Appel LJ, Sacks FM, Carey VJ, et al. Omni- Heart Collaborative Research Group. Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial. JAMA. 20053294(19):2455-2464.

Schmidlin O, Forman A, Tanaka M, Sebastian A,

Morris RC Jr. NaCl-induced renal vasoconstriction

in salt-sensitive African Americans: antipressor and hemodynamic effects of potassium bicarbonate. Hypertension. 1999;33(2):633-639.

Chen J, He J, Hamm L, Batuman V, Whelton PK. Serum antioxidant vitamins and blood pressure in the United States population. Hypertension. 2002;40(6):810-816. Young DB, Lin H, McCabe RD. Potassium’s car- diovascular protective mechanisms. Am J] Physiol. 1995;268:R825-R837. Green DM, Ropper AH, Kronmal RA, Psaty BM,

Burke GL. Cardiovascular Health Study. Serum potassium level and dietary potassium intake as risk factors for stroke. Neurology. 2002;59(3):314-320.

48.

49.

50.

ili

aS.

DASH for Korean Americans

Macdonald JE, Struthers AD. What is the optimal

serum potassium level in cardiovascular patients? J Am Coll Cardiol. 2004;43(2):155-161. Conlin PR, Chow D, Miller ER 3rd, et al. The

effect of dietary patterns on blood pressure control in hypertensive patients: results from the Dietary Approaches to Stop Hypertension (DASH) trial. Am J Hypertens. 2000;13(9):949-955. Kim EY, Han HR, Jeong S, et al. Dose knowl-

edge matter? Intentional medication nonadher- ence among middle-aged Korean Americans with high blood pressure. J Cardiovasc Nurs. 2007;22(5):397-404. Kim MT, Kim EY, Han HR, et al. Mail edu-

cation is as effective as in-class education in hypertension Korean patients. J Clin Hypertens.

2008310:

176-184.

Kang JH, Han HR, Kim KB, Kim MT. Barriers

to care and control of high blood pressure in Korean-American elderly. Ethn Dis. 2006;16(1):

145-151. Han HR, Kim KB, Kang J, Jeong S, Kim EY,

Kim MT. Knowledge, beliefs, and behaviors

about hypertension control among middle-aged Korean Americans with hypertension. |] Commu-

nity Health. 2007;32(5):324-342.

Reprinted

with permission.

APPENDIX E

SHARING A TRAUMATIC EVENT The Experience of the Listener and the Storyteller Within the Dyad

Jeanne Cummings

> Background: \ndividuals who have experienced as it was remembered, told, and listened to in a

traumatic events often share their experiences nonlinear, multifaceted way. The listener and the

in story form. This sharing has consequences for storyteller collaborated, adapted, and responded

both storytellers and listeners. Understanding the physically, mentally, emotionally, and spiritually.

experience of both members of the listener—story- > Key Words: dyad - Flight 1549 - listening - Miracle

teller dyad is of value to nurses who are often the on the Hudson - nursing - storytelling - trauma

listener within the nurse—patient dyad.

> Objective: The aim of this study was to illuminate

the experiences of the listener and the storyteller Trauma is any distressing event or psychologi-

when a traumatic event is shared within the dyad. cal shock from experiencing a disastrous event

> Methods: The phenomenon was explored using an (Webster’s Dictionary, 2001, p. 760). The sur-

interpretive phenomenological approach. Partici- geon general has recognized trauma as a major

pants consisted of 12 dyads, each with a storyteller public health risk (Courtois & Gold, 2009).

and a listener. The storytellers were individuals Individuals can directly experience a trauma or

who had been involved in US. Airways Flight can be indirectly traumatized through witness- 1549 when it crash-landed in the Hudson River in ing or other forms of secondhand exposure

January 2009. Each storyteller identified a listener (Courtois, 2002). In a national survey of the

who had listened to them share their story of this general population, 60% of men and 51% of

event, dubbed The Miracle on the Hudson. In-depth women reported having experienced at least

interviews were conducted with each storyteller one traumatic event in their lifetime (Kessler,

ene JERS Sonnega, Bromet, Hughes, & Nelson, 1995). > Results: Five essential themes emerged from the Peaple who have experienced traumaric

data: Theme 1, The Story Has a Purpose; nemo, events may tell trauma stories that are frag- The Story as a Whole May Continue to Change as mented and disjointed, and understanding Ditferent Parts Are Revealed; Theme 3, The Story Is these stories can be complicated and chal-

Experienced Physically, Mentally, Emotionally, and lenging (Leydesdorff, Dawson, Burchardt,

Spiritually; Theme 4, Imagining the “What” as well as & Ashplant, 2009). Trauma is experienced

the “What If”; and Theme 5, The Nature of the Rela- pee eee ve pocanal

tionship Colors the Experience of the Listener and the (Penk ver 2000)-4tomateaumanctryivor.

Storyteller. Roy's Adaptation Model of Nursing was putting the story and its imagery into words is

found to be applicable to the findings of this study. thersoaltoereco verve (Henman<1992pat77)0

> Discussion: For the participants in this study, the Being asked to share traumatic experiences

experience of sharing a traumatic event involved lets storytellers know that listeners recognize

facts, feelings, and images. The story evolved them and their suffering (Rosenthal, 2003).

Reprinted with permission from Cummings, J. (2011). Sharing a traumatic event: The experience of the 273

listener and the storyteller within the dyad. Nursing Research, 60(6), 386-392.

274 APPENDIXE ® Sharing a Traumatic Event

The absence of an invitation to share may

convey the message that these experiences

are unspeakable or unbearable to listen to; in addition, delayed disclosure and negative reactions to disclosure have been associated with poor adjustment (Ullman, 2007). When

people avoid talking about a traumatic event

with a victim, the victim may interpret it as a

lack of concern and support (Guay, Billette &

Marchand, 2006). Esposito (2005) found that

women who had been raped failed to disclose the rape during many subsequent encounters with healthcare providers because no one ever

asked them about it. In a study of veterans,

it was reported that when healthcare provid-

ers asked them about previous trauma, 71%

disclosed a history of trauma; nearly 45% remembered receiving a negative response to

their disclosure and 30% felt they had not

been believed (Leibowitz, Jeffreys, Copeland, & Noel, 2008). Symonds (1980), who

worked with crime victims, described the sec-

ond wound, which he defined as “the victim’s

perceived rejection by and lack of expected support from the community, agencies, fam-

ily, friends, and society in general” (p. 37). Nurses and other healthcare professionals

risk creating a second wound if they do not acknowledge trauma, fail to invite the patient to share, or respond in a way that does not feel meaningful to the patient.

For nurses, listening is one way of respond-

ing and adapting to patients within the nurse- patient relationship. The essence of nursing

through the ages has been rooted in the relation-

ship between nurse and patient (Roy, 1988).

In Roy’s Adaptation Model of Nursing, the

person is conceptualized as an adaptive system functioning toward a purpose (Roy, 1988). In

Roy’s theory, it is proposed that, as adaptive

systems, humans respond to stimuli to initiate

a coping process, which has an effect on behavior that leads to responses that are either

adaptive or ineffective (Perrett, 2007).

Sharing a traumatic event has

consequences for both listener and

storyteller.

Nurses who bear witness to trauma sur-

vivors should keep in mind that “just talking without being listened to is not enough; the one that talks must find someone who will listen” (Vajda, 2007, p. 90). In addition, as

Bunkers (2010) observed, there is more to

listening than hearing the words of another person. When nurses are listeners for story- telling patients, a dyad is formed. In a dyad, each person must relate directly to the other;

thoughts and feelings are engaged (Moreland, 2010). The act of listening enables humans to be present and to bear witness to one another

(Kagan, 2008). By remaining present, listeners

can create a space for storytellers to reveal themselves, the experience, and the story.

“Stories are told with, not only to, listeners”

(Frank, 2000, p. 354). Pasupathi and Rich

(2005) found that storytellers told shorter

stories and experienced negative emotions

when listeners were distracted. They also found that, when listeners did not respond

to the meaning in the story, storytellers had

problems completing the story. Listening to the patient’s story is part of the

emotional labor of healthcare (Barrett et al.,

2005). Repeatedly listening to trauma stories

is not without effect on listeners. Exposure to

accumulated stress and secondary trauma can result in compassion fatigue; individuals can become fatigued, depressed, and withdrawn and can lose interest. They can experience

recurrent thoughts and images, somatic symp-

toms, and anger (Showalter, 2010). Shortt and

Pennebaker (1992) found that, as dyads of

listeners and storytellers shared a story of the

Holocaust, the listeners’ heart rate increased

and the storytellers’ heart rate decreased.

Nurses and social workers were reported to have strong physical sensations when doing traumatic clinical work (Raingruber & Kent,

2003). Baird and Kracen (2006) documented

secondary stress reactions and posttraumatic stress disorder symptoms in trauma therapists. These reactions may affect the treatment pro- cess as well as the therapist’s own experience (Canfield, 2005). Listening to trauma stories

may affect the listener; the storyteller may sense this and adapt by changing the way they share.

APPENDIXE #8 mo

Nurse practitioners have described lis-

tening as the most valuable skill they have

(Parrish, Peden, & Staten, 2008). Hearing

the patient’s story helps in understanding the

patient as a person (Barrett et al., 2005). In

spite of the emphasis in nursing education on the importance of listening to the patient,

“there is a paucity of nursing literature on lis-

tening” (Kagan, 2008, p. 109). Little informa-

tion is available on what listening to stories

of traumatic events is like for nurses, how

they may be affected by such stories, and how the patient experiences the nurse as listener. This study sought to illuminate the experi- ence of the listener and the storyteller when a

traumatic event is shared within the dyad by

interviewing individuals who told their story

of being involved in the crash-landing of a plane and the people who listened to them.

The knowledge gained from this study has

implications for individuals who share stories

of traumatic events and the nurses and other healthcare professionals who listen to them.

@ Methods

DESIGN

An interpretive phenomenological research

approach, as outlined by van Manen (1997), guided this study. Van Manen believed that lived experience was the starting and ending

point of phenomenological research (van

Manen, 1997). This approach was chosen as

a way to gain a deeper understanding of the

lived experience of individual participants. The personal experiences that were part of the public traumatic event may not have been known by others. This study was done to illu-

minate the experience of the listener and the

storyteller when a traumatic event was shared

within the dyad.

SETTING AND SAMPLE

The context was the crash-landing of a plane,

which was the traumatic event.

Reprinted

with permission.

Sharing a Traumatic Event 275

On January 15, 2009, U.S. Airlines Flight 1549, bound for Charlotte, North Carolina,

took off from a New York airport carrying 150 passengers and 5 crew members. The

plane lost engine thrust shortly after takeoff when a flock of Canadian geese flew into the engines. It crashlanded in the Hudson River in

New York City, and all those on board sur-

vived. The good news of this event, which the

media dubbed Miracle on the Hudson, spread

throughout the country. Despite its outwardly

happy ending, the event would be considered traumatic for the individuals involved.

DATA COLLECTION

A purposive sample was obtained in that indi-

viduals were sampled in order to purposefully inform an understanding of the phenomenon

under study (Creswell, 2007). As primary

investigator (PI), I obtained institutional review

board approval from my academic setting.

I then sent an invitation to participate to

potential participants. It was sent via e-mail

to 20 potential storyteller participants by

an individual who had contact with those involved in Flight 1549. The invitation

contained an overall description of the study, including the purpose, and the PI’s name,

background, and contact information. The 12

storyteller participants who responded and

agreed to be in the study then asked some- one who had listened to them tell their story

previously if he or she would be interested

in participating in the study as the listener member of the storyteller—listener dyad. If the listener agreed, he or she responded via

e-mail. Listeners were then sent the original

e-mail invitation. The purposive sample consisted of 24 partic-

ipants forming 12 dyads, each with a storyteller and a listener. These spouse, friend, sibling, and

parent dyads included 9 men and 15 women,

with ages ranging from 29 to 74 years. Signed

consent, including permission to be audio- taped, was obtained from all participants who

were made aware that their participation was

voluntary and that they had the right to stop

Generating and Assessing Evidence for Nursing Practice (11th ed.)

276 APPENDIXE ® Sharing a Traumatic Event

participation or withdraw from the study at any time without penalty. Information regarding the

availability of mental health counseling was also provided to participants.

In-depth interviews were done face to face with 21 participants; the remaining three

interviews were conducted on the telephone

because of participant availability. Each storyteller and each listener were asked to

speak about what their experience was like

when the traumatic event was shared within

the dyad. Each storyteller was asked, “Tell

me what it was like to tell your story to

[name of listener].” Each listener was asked,

“Tell me what it was like listening to [mame

of storyteller] tell you [his or her] story.”

The interviewer encouraged participants to

share their experiences by asking nonleading

questions such as “Tell me more about your

experience” until participants felt they had no

more to say on the topic. The interviews were

audiotaped, assigned pseudonym titles, and

downloaded individually to a secure server.

Each audiotape was transcribed verbatim

by a transcriptionist who had completed the Human Subjects Research in Social and

Behavioral Sciences module as well as the

Research Integrity module. Names were

removed during transcription. After the tran- scription was completed, each transcript was reviewed for completeness and to ensure that all identifying information was removed.

DATA ANALYSIS

Data analysis was carried out according to the

process described by van Manen (1997). The

following steps were taken to achieve rigor;

preconceived notions and beliefs were put aside

about the phenomenon under study. A holistic reading was done of each transcript to get a sense of it as a whole and then read again to

see what statements or phrases seemed to best

represent the experience of the participants.

During these readings, notes were made in the margins, using different color highlighters for what appeared to be different catego- ries of statements. Each of the statements or

phrases was listed in categories that seemed to be related. After repeatedly reviewing and dwelling with the data, five essential themes were identified, after determining that the

phenomenon would lose its meaning without

the inclusion of these themes. As a way to further maintain rigor, the PI

collaborated with two professional colleagues and expert qualitative researchers who reviewed transcripts and findings; each had more than 20 years of experience in qualita-

tive research. A journal was kept to record additional observations and personal reflec- tions. Findings were presented and clarified with participants to assess whether the tran- scripts were accurate and whether the identi-

fied themes resonated with them. According

to Lincoln and Guba (1985), “The criterion

for objectivity is intersubjective agreement;

if multiple observers agree on a phenome-

non, then their collective judgment can be said to be objective” (p. 292). Saturation,

as described by Lincoln and Guba (1985),

was achieved upon interviewing nine dyads,

as there was no new or different informa- tion emerging; however, a total of 12 dyads were interviewed to confirm redundancy and

maintain rigor. There was intersubjective

agreement on themes between the PI, partici- pants, and expert qualitative researchers. Five

essential themes were supported in the form of narrative excerpts from participants.

# Results

The five essential themes and the data to support them are discussed in the sections that follow.

ESSENTIAL THEME 1: THE STORY HAS A PURPOSE FOR THE LISTENER AND THE STORYTELLER

Purposes identified included sharing the facts

and the special story, giving inspiration, and providing a benefit to the storyteller and the

APPENDIXE & ro

listener. Personal experience often differed

from public media presentation. One sto- ryteller noted, “I guess there’s almost this compulsion to set the record straight and say, ‘It’s still a wonderful story, and we are

so fortunate, and it could have been so much

worse, but let me tell you, it wasn’t as easy as

you think.’”

Storytellers wanted to inspire: “I’ve seen the really, really strong inspirational impact

it had on certain people. That’s the kind of impact I want to have when I tell it because

that’s the most rewarding for me.” In turn, many listeners described experiencing a

feeling of awe while listening. Storytellers and listeners spoke of feeling that the story was

special. A listener smiled and whispered, “I

love the story.” A storyteller described the

story, “It’s a little bit, maybe, too big of a

word—sacred—but just special, very special.”

Many felt that an incomplete version was

disrespectful. One storyteller felt that “the worst thing that can happen when you are

telling somebody about something like this, it’s either dismissiveness or indifference.”

It was revealed repeatedly that the story-

tellers did not mind telling their story and felt

that telling was helpful to them. One story- teller said, “I could probably go on a ramble

about it as long as anybody would listen.” She went on to say, “It was very therapeutic,

saying it over and over; it helped me remem-

ber things.” Another storyteller explained, “Talking about it was actually a way for me to release, not to keep it in, because I think I

know myself enough: I keep it in, and it will just burn a hole.” In some dyads, the listen-

ers had the impression that the storyteller preferred to avoid telling the story. A listener shared her belief, “I know she did not want

to tell it all the time.” Another commented, “I

did not have a sense that he needed to share

or get support.” These statements revealed

that listeners sometimes had a different perception of the storyteller’s desire to tell the story and were unaware of the benefit of

doing so. Another benefit of telling the story was

reflected in the fact that, as time went on,

Reprinted

with permission.

Sharing a Traumatic Event 277

listeners and storytellers noticed that the

more they shared, the easier it got. They felt

less emotionally and physically reactive. A

storyteller explained, “Over time, I feel less

bad about it. The trauma of the actual event

has subsided some.” A listener found that her responses had changed as well: “You know, I

still get the chills on occasion, but it’s not as emotional as it was for the first few months.” A storyteller explained, “Going through it

over and over and over again, it got easier

and easier. I don’t think I could have healed without—and I really feel that I healed from it.” All participants spoke about learning

and gaining a sense of understanding as they shared. A listener recalled, “Each time we’d

share, we'd learn a little something.” A sto-

ryteller recalled that, “Telling it, it helped me process it to a certain extent.”

ESSENTIAL THEME 2: THE STORY THAT IS KNOWN AS A WHOLE MAY CONTINUE TO CHANGE AS DIFFERENT PARTS OF IT ARE REVEALED

Participants talked about how the story was

remembered, told, and listened to in bits

and pieces—that there was a “worst part” to the story and that the story evolved as information was gathered. All participants

were drawn to fill in the holes of the story

or elaborate on specific parts. A storyteller

explained, “So in the beginning, it was proba- bly a lot of—I was probably—definitely more scattered. So I maybe couldn’t have told it in

a linear fashion.” She remembered things as she shared: “So it was a progression to where my story is today, and I—it may change; I don’t know that it’s complete. I suspect there will be continued learnings, there will be the

evolution.” Listeners also were aware of the

evolution of the story: “Listening in those respects over the next 4 or 5 months when

bits and pieces would come in, it would be more of an unveiling of something.” The lis- tener and the storyteller often collaborated to

piece the story together, accepting what they knew in the present moment to be the story

Generating and Assessing Evidence for Nursing Practice (11th ed.)

278 APPENDIXE &

while being open to the possibility of change

in the future. Even though parts of the story changed

as information was gathered, the part of the

story that was identified as the worst part

never changed. A listener revealed the worst

part for her: “He thought he was going to die.

But the most painful was the next day, when

I got to process it more.” There is no way

to know what the worst part was for each

individual without asking them. A storyteller

recounted what was the worst part for him:

“We're going down, and he’s already told us

to brace for impact, and I start thinking about

what I was thinking then.... That would get

me choked up every time.”

ESSENTIAL THEME 3: THE STORY IS OFTEN EXPERIENCED PHYSICALLY, MENTALLY, EMOTIONALLY, AND SPIRITUALLY

Both members of the dyad were aware of

physical manifestations of emotion reflected

in the body, the face, and the eyes of the

other as the story was shared. Simultaneous

listener-storyteller nonverbal communica-

tion added to the collaborative nature of the

experience within the dyad. The observation, perception, and interpretation of these non-

verbal cues affected the creation, cessation,

and modification of dialogue as well as the

images, emotions, and physical sensations

experienced. For example, the responses of the listener often validated the storyteller: “Just to see the reaction on other people’s faces makes you realize exactly how traumatic

the experience was.” This storyteller described

her awareness of the listener as she spoke: “I

do notice if I feel like they’re actually inter- ested in listening to what I’m saying or not. I

notice it in people’s faces.” She found herself responding to these nonverbal cues: “I’m very

big on mannerisms and stuff like that. If I felt like they were losing interest, then I probably would just quit talking about it.”

Participants also had physical reactions

to the experience. One listener remembered “that nonstop crying and the throwing up.”

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Sharing a Traumatic Event

A storyteller noted, “I can get varying degrees

of physical response, tightening, tensing up,

or I found myself fidgeting and stuff like that; the heart rate starts to go up a little bit.” The

listener in this dyad remembered she would

“get goose bumps at a certain point when he

would talk about it.” Listeners and storytellers experienced the

story mentally through images. This occurred

spontaneously at times, and at other times, the

participant actively tried to picture things. In

one dyad, the storyteller recalled, “So when I

started telling about it was—it was the pictures

playing over and over in my head.” In the same

dyad, the listener revealed, “I could almost tell

you what she looked like; I could picture her

there.” Another listener talked about “seeing”

the storyteller’s experience as she escaped the cabin of the plane. “You know, getting out

on that wing, I almost—it’s almost like, you

know, I can almost—I can see the light.” He

imagined being there: “Ill be thinking about it, and maybe listening to her, and at the same

time maybe trying to imagine what it’s like

being right alongside of her.” Participants

often described a sense of erealisation as they

shared the story of the traumatic event. A

storyteller felt as though he was “dreaming.” A

listener recalled thinking, “This is surreal.”

While telling or listening, participants

experienced the story emotionally. A story-

teller elaborated: “When I talk about it and remind her how much she means, it definitely gets her emotional, I know it does. And I, in turn, get emotional.” The listener in this dyad

was clear about the emotional impact that

listening had on her: “I was, like, trauma-

tized by this, you know, by listening to it.”

She called her experience an “emotional roller coaster.” Both listeners and story-

tellers reported feeling as though they were reliving the experience as it was shared. A

storyteller recalled, “When I’m going through

the narrative, it’s like in a lesser degree as

time has gone on—but it’s kind of happening again, and instead of just talking about the emotional part, it’s more like you’re feeling the emotional part.” A listener felt that things came alive as she listened: “And so as he

Reprinted

with permission.

speaks, and I’m listening, then J am, if you will, reprocessing. I’m reliving, I’m recount- ing. ’m—it’s real.”

Participants also had spiritual experiences. As one listener put it, “God was providing me a moment by moment peace” as the story- teller shared bits of what had happened early on. Another listener felt a presence. She had a “feeling wash over her” and felt as if “some- one was trying to comfort me—like maybe it was the Holy Ghost.”

ESSENTIAL THEME 4: IMAGINING THE “WHAT” AS WELL AS THE “WHAT IF” IS DONE BY BOTH LISTENER AND STORYTELLER

Many participants found themselves imagin- ing what happened as well as what could have happened. When a storyteller imagined the what if, he thought about “the things I was going to miss out on, J wouldn’t—alJJ those missed-out-on things that haven’t happened yet. And every time I'd think about that, and how lucky I am to do some of those things, I just get choked up.” One storyteller imagined what it would be like to lose his wife, the listener, and, at the same time, what it would

have been Jike for her to Jose him: “I always try to reflect in other people’s shoes, and if I lost my wife, it would be devastating. It would have been very painful for her [to lose me}. Still painful for her [to contemplate], I’m

sure, but it didn’t work out that way.” Many listeners imagined what had hap-

pened and what it was like for the storytellers by putting themselves in their shoes. A listener revealed, “Every time she was telling it,

I would think—I would picture myself in her situation. I see me doing it. I wasn’t listening as much as I was picturing myself in it.” One listener imagined two aspects of walking in the other’s shoes. First, she imagined how the storyteller had experienced the event: “It was amazing to listen and then try to put myself in his shoes to really try and comprehend the thought processes that he was describing.”

Generating and Assessing Evidence for Nursing Practice (11th ¢d.) with permission.

APPENDIZE = Sharing a Traumatic Event 279

Sharing stories of traumatic events is one way of responding and adapting to the stimulus of trauma.

Second, she imagined experiencing the event herself “Once J get a feel for things I step into a role, but I’m going to—so as he tells the story, then J try and put myself in his shoes, and how would J have reacted?”

Some participants, in contrast, felt that

they could never imagine putting themselves in the shoes of the other: “There is no way you can understand; there’s no way, even if you'd had a similar experience, that you can put yourself in their shoes.” They may have

understood the facts but have been unable to achieve a deeper understanding of the lived EXPEerience.

ESSENTIAL THEME 5: THE NATURE OF THE RELATIONSHIP COLORS THE EXPERIENCE OF THE LISTENER AND THE STORYTELLER WHEN A TRAUMATIC EVENT IS SHARED WITHIN THE DYAD

The listener, the context, the type of relation- ship, and the amount of time the dyad spent together affected the experience of sharing. A storyteller observed, “A Jot of that storytell- ing has to do with the listener, too.” He said

that he “tells the story differently depend- ing on who he is talking to.” Sometimes storytellers altered the story to protect the listener. One storyteller told me, “I didn’t want to burden her. I didn’t want to—I just

didn’t want to upset ber.” The listener in this dyad explained, “She doesn’t want me to really know how it really was. . -and she was worried about me.” Other listeners felt that they had listened so often they knew the story by heart: “It’s become very familiar, and I could almost, you know, recite at least

parts of it.” Storytellers always made decisions about

whom to share their story with: “It’s almost like because it’s such a personal and deep experience, you sort of don’t want to waste

ee et

280 APPENDIXE #

it on people. . . . It’s precious, like a piece

of gold.” They considered the reactions of listeners: “When somebody acknowledges your feelings—and not just acknowledges; somebody says, ‘Oh, this must have been this and that’-—it makes you more willing to dis-

cuss your feelings that maybe you were a little

more reserved about before.” That some listeners felt they had had

enough of listening and wanted to move on

was evident in the study findings. A listener

explained, “It’s not so therapeutic for me to

keep reliving that, I guess.” Another listener

described being “sick of hearing the story”

and expressed a desire to “move on, some

normalcy.” As a way to cope, another listener

revealed an attempt to actively try not to

listen: “I just think I knew Id heard it, and

I didn’t want to have to get it in my mind again.” Another listener became “exhausted,

definitely exhausted” after fully listening for

a very long time. However, she was one of

several listeners who said they would continue

to listen if the storyteller needed them to: “I

mean, I was there to support, as I still am, and

that’s just what you do.” Adding, “I wouldn’t

have done anything differently.”

Continuing to listen for the sake of the

other despite feeling as though they had had

enough of listening may affect listeners as well as storytellers. Storytellers had some aware-

ness of listener saturation and desire to move

on. One storyteller believed that, after initially

hearing the entire story, the listener had met

her capacity for listening and had become

saturated; he said, “She doesn’t really want

to hear it.” Another storyteller worried about

the effect on the listener: “I would not want

to bore people...I don’t want to wear some- body out with it.”

All storytellers noted that when they

were with other people who had shared the

traumatic experience, they felt understood:

“That’s the bestcase scenario because they

really understand what’s going on. . . because

they understand what I went through.” One

storyteller added, “Unless you’ve lived it, there’s no comparison.”

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Sharing a Traumatic Event

INTEGRATED ESSENTIAL ESSENCE

The meaning of phenomenological description

lies in its interpretation, its aim to transform

lived experience by breathing meaning into a

textual expression of its essence (van Manen,

1997). A textual interpretative statement was

formulated from essential themes as a sum- mary of the experience. An integrated essen-

tial essence was created to capture the essence

of the experience of the listener and the story- teller when a traumatic event is shared within the dyad. The Integrated Essential Essence is as follows. The traumatic event is lived by an

individual who, in an attempt to understand

his or her own experience and to eventually

have it understood by another, forms a story

about the event and his or her experience and shares it with a listener, forming a unique dyad. Seeking physical, psychic, and spiri- tual integrity, the listener and the storyteller

collaborate, sharing the story of the trau- matic event and the experience in a complex, nonlinear multifaceted way, continuously

adapting while attempting to create a sense of

meaning through the experience.

@ Discussion

IMPLICATIONS FOR NURSING

For nurses, inviting an individual to share his or her experience of a traumatic event is a

way to say, “I see you; come, share your story

with me, and I will listen.” Initial assessments

are not complete without this invitation.

This study revealed a collaborative, adaptive

process between listener and storyteller, con- sistent with Roy’s Adaptation Model. It was

revealed that the listener and the storyteller

acted as interdependent parts, collaborating

as they shared the story of the traumatic event within the dyad. Participant’s individual pat- terns of adaptation and individual attempts at coping were illuminated, providing a deeper

understanding of the lived experiences of these individuals.

Reprinted

with permission.

APPENDIXE ~~

Sharing stories of traumatic events is one way of responding and adapting to the stimu-

lus of trauma. In this study, the results showed that despite feeling as though they had had enough of listening and wanted to move on, some listeners adapted by continuing to try to listen. Nurses may do the same. Just as some

athletes develop stress injuries, some nurses who listen repeatedly to stories of traumatic events may develop stress injuries. This pattern

may carry a risk for both nurse and patient. Nurses may continue to listen for the sake of their patients; however, they may experience

compassion fatigue and, as a result, may tire,

withdraw, and lose interest. Patients may sense

this and adapt by altering their trauma story or by not sharing it at all. Focusing more inten- sively on listening within nursing curricula may be of value. Preventing stress injury, exploring

ways to promoting resilience, and illuminating

ways for nurses to be with patients so they are

able to share their stories of traumatic events

are of value to nursing.

IMPLICATIONS FOR FUTURE RESEARCH

Nursing education includes the topic of thera- peutic communication. However, few studies

have explored how the patient experiences the nurse during this communication and what

it is like for nurses to be fully present while listening. Further dyadic studies exploring the

experience of sharing a traumatic event within

the nurse—-patient dyad may reveal patterns

related to listening, being heard, presencing, resilience, and burnout or compassion fatigue.

Future studies exploring the experience of sharing a traumatic event in specific rela- tionship dyads may reveal different patterns.

For example, veterans are returning from

war having experienced traumatic events.

Exploring what it is like for these individuals

and their significant others to share these events may add to the understanding of their

experience. Also highlighted in the results of this study

was the sense of understanding that often

Reprinted with permission.

Sharing a Traumatic Event 281

exists among individuals who have shared

similar experiences. Nurses who have expe- rienced traumatic events and work-related

stress injuries may benefit from sharing these

with other nurses who have had similar expe- riences. This sense of mutual understanding may be a protective factor in recovery from

work-related stress, burnout, and compassion

fatigue.

STRENGTHS AND LIMITATIONS

A strength of this dyadic study was that it enabled the perspective of both listener and

the storyteller to be illuminated. The findings may be of value to the nurse-patient dyad,

because the nurse is often the listener to the patient storyteller when a traumatic event

is shared. The fact that three participants were interviewed on the telephone may have

changed what was shared; however, there did not seem to be any differences in the findings among these participants. A potential bias is

that the PI’s brother was a passenger on the plane. He was not a participant in the study.

CONCLUSIONS

This study illuminates the experience of the listener and the storyteller when a traumatic

event is shared within the dyad. In this study,

it was revealed that, when the traumatic event

is shared, the story includes more than factual

events; it is accompanied by feelings and images. The story evolved as it was remem- bered, told, and listened to in a nonlinear,

multifaceted way. When the traumatic event

is shared within the dyad, the listener and the storyteller collaborate, adapt, and respond

physically, mentally, emotionally, and

spiritually.

Jeanne Cummings, DNS, RN, NP, CS, BC, is

Visiting Professor, The Graduate Center, City

University of New York. DOI: 10.1097/NNR.06013e3 182348823

282 APPENDIXE #8

Accepted for publication August 15, 2011. The author thanks her brother (a passen-

ger on Flight 1549) for his assistance in providing access to potential participants.

The author also thanks the participants for generously sharing their experiences. The

author has no funding or conflicts of interest to disclose.

Corresponding author: Jeanne Cummings,

DNS, RN, NP, CS, BC, The Graduate

Center, City University of New York,

Doctor of Nursing Science Program, 365

Fifth Avenue, New York, NY 10016-4309

(e-mail: [email protected]).

REFERENCES Baird, K., & Kracen, C. (2006). Vicarious traumati-

zation and secondary traumatic stress: A research synthesis. Counselling Psychology Quarterly, 19, 181-188. doi: 10.1080/09515070600811899.

Barrett, C., Brothwick, A., Bugeja, S., Parker, A., Vis,

R., & Hurworth, R. (2005). Emotional labour: Lis-

tening to the patient’s story. Practice Development in

Health Care, 4, 213-223. doi: 10.1002/pdh.17.

BenEzer, G. (2009). Trauma signals in life stories. In

Rogers, K. L., Leydesdorff, S., & Dawson, G. (Eds.),

Life stories of survivors of trauma (pp. 29-44). New

Brunswick, NJ: Transaction Publishers. Bunkers, S. S. (2010). The power and possibility in

listening. Nursing Science Quarterly, 23, 22-27. doi: 10.1117/0894318409353805.

Canfield, J. (2005). Secondary traumatization, burn- out, and vicarious traumatization: A review of the

literature as it relates to therapists who treat trauma.

Smith College Studies in Social Work, 75, 81-101.

doi: 10.1300/j497v75n02_06. Courtois, C. A. (2002). Traumatic stress studies: The

need for curricula inclusion. Journal of Trauma Practice, 1, 33-57. doi: 10.1300/J189v01n01_03.

Courtois, C. A., & Gold, S. (2009). The need for

inclusion of psychological trauma in the professional curriculum: A call to action. Psychological Trauma: Theory, Research, Practice, and Policy, 1, 3-23. doi: 10.1037a0015224.

Cresswell, J. (2007). Qualitative inquiry & research design, choosing among five approaches. Lincoln, NE: Sage.

Esposito, N. (2005). Manifestations of enduring

during interviews with sexual assault victims. Qualitative Health Research, 15, 912-927. doi: 10.117/1049732305279056.

Frank, A. W. (2000). The standpoint of the storyteller.

Qualitative Health Research, 10, 354-365. doi:

10.1177/104973200129118499.

Sharing a Traumatic Event

Guay, S., Billette, V., & Marchand, A. (2006). Explor-

ing the links between posttraumatic stress disorder and social support: Processes and potential research avenues. Journal of Traumatic Stress, 19, 327-338.

doi: 10.1002/jts.20124. Herman, J. (1992). Trauma and recovery. New York,

NY: Basic Books. Kagan, P. N. (2008). Listening: Selected perspectives in

theory and research. Nursing Science Quarterly, 21, 105-110. doi: 10.1177/0894318408315027.

Kessler, R. C., Sonnega, A., Bromet, E., Hughes, M., & Nelson, C. (1995). Posttraumatic stress disorder in

the national comorbidity study. Archives of General

Psychiatry, 52, 1048-1060. Leibowitz, R. Q., Jeffreys, M. D., Copeland, L. A., & Noel, P. H. (2008). Veterans’ disclosure of trauma to healthcare providers. General Hospital Psychiatry, 30, 100-103. doi: 10.1016/j.gen-

hosppsych.2007.11.004. Leydesdorff, S., Dawson, G., Burchardt, N., &

Ashplant, T. G. (2009). Trauma and life stories. In

Rogers, K. L., Leydesdorff, S., & Dawson, G. (Eds.),

Life stories of survivors of trauma (pp. 1-26). New Brunswick, NJ: Transaction Publishers.

Lincoln, Y., & Guba, E. (1985). Naturalistic inquiry.

Newbury Park, CA: Sage. Moreland, R. (2010). Are dyads really groups?

Small Group Research, 41, 251-267. doi: 10.1177/1046496409358618.

Parrish, E., Peden, A., & Staten, R. (2008). Strate-

gies used by advanced practice psychiatric nurses in treating adults with depression. Perspectives in Psychiatric Care, 44, 232-240. doi: 10.1111/j.1744-

6163.2008.00182.x. Pasupathi, M., & Rich, B. (2005). Inattentive listening

undermines self verification in personal storytell- ing. Journal of Personality, 73, 1051-1086. doi: 10.1111/).1467-6494.2005.00338.x.

Perrett, S. E. (2007). Review of Roy Adaption Model-based qualitative research. Nurs- ing Science Quarterly, 20, 349-356. doi: 10.1177/0894318407306538.

Raingruber, B., & Kent, M. (2003). Attending to em-

bodied responses: A way to identify practice-based and human meanings associated with secondary trauma. Qualitative Health Research, 13, 449-468. doi: 10.1177/1049732302250722.

Rosenthal, G. (2003). The healing effects of storytelling

on the conditions of curative storytelling in the con- text of research and counseling. Qualitative Inquiry, 9, 915-933. doi: 10.1177/1077800403254888.

Roy, C. Sr. (1988). An explication of the philo- sophical assumptions of the Roy Adaptation Model. Nursing Science Quarterly, 1, 26-34. doi: 10.1177/089431848800100108.

Shortt, J., & Pennebaker, J. (1992). Talking versus

hearing about Holocaust experiences. Basic and Applied Psychology, 13, 165-179. doi: 10.1207/ $15324834basp1302_2.

Reprinted

with permission.

APPENDIXE wo

Showalter, S. (2010). Compassion fatigue: What is

it? Why does it matter? Recognizing the symptoms, acknowledging the impact, developing the tools to prevent compassion fatigue and strengthen the pro- fessional already suffering from the effects. American Journal of Hospice and Palliative Medicine, 27(4), 239-242. doi: 10.1177/1049909109354096.

Symonds, M. (1980). The second injury to victims. Evaluation and Change, 4, 36-38.

Ullman, S. E. (2007). Relationship to perpetrator, disclosure, social reactions, and PTSD symptoms in child sexual abuse survivors. Journal of Child Sexual Abuse, 16, 19-36. doi: 10.1300/4070v16n01-02.

Sharing a Traumatic Event 283

Vajda, J. (2007). Two survivor cases: Therapeutic effect as side product of the biographical narrative interview. Journal of Social Work Practice, 21, 89-102. doi: 10.108002650530601173664.

van Manen, M. (1997). Researching lived experience

(2nd ed.). Winnipeg, Manitoba, Canada: Althouse Press.

Webster’s dictionary. (4th ed.). (2001). New York, NY: Ballentine Books.

FATIGUE IN THE PRESENCE OF

CoRONARY HEART DISEASE Ann L. Eckhardt

Catherine J. Ryan e

> Background: Fatigue is a prevalent and disabling

symptom associated with many acute and chronic

conditions, including acute myocardial infarction

and chronic heart failure. Fatigue has not been

explored in patients with stable coronary heart

disease (CHD).

> Objectives: |he purpose of this partially mixed

sequential dominant status study was to (a)

describe fatigue in patients with stable CHD;

(b) determine if specific demographic (gender,

age, education, income), physiological (hy-

pertension, hyperlipidemia), or psychological

(depressive symptoms) variables were correlated

with fatigue; and (c) determine if fatigue was

associated with health-related quality of life.

The theory of unpleasant symptoms was used as

a conceptual framework.

> Methods: Patients (N= 102) attending two

cardiology clinics completed the Fatigue Symptom

Inventory, Patient Health Questionnaire-9, and

Medical Outcomes Study Short Form-36 to measure

fatigue, depressive symptoms, and health-related

quality of life. Thirteen patients whose interference

from fatigue was low, moderate, or high partici-

pated in qualitative interviews.

> Results: Forty percent of the sample reported

fatigue more than 3 days of the week lasting more

than one half of the day. Lower interference from

fatigue was reported on standardized measures

compared with qualitative interviews. Compared

with men, women reported a higher fatigue inten-

sity (9 = .003) and more interference from fatigue

(p= .007). In regression analyses, depressive symp-

toms were the sole predictor of fatigue intensity

and interference.

Holli A. DeVon

Julie J. Zerwic

e MariannR. Piano e

> Discussion: Patients with stable CHD reported

clinically relevant levels of fatigue. Patients with

stable CHD may discount fatigue as they adapt

to their symptoms. Relying solely on standardized

measures may provide an incomplete picture of

fatigue burden in patients with stable CHD.

> Key Words: coronary heart disease ¢ fatigue ¢

mixed methods

Fatigue is often defined as the subjective sen- sation of extreme and persistent exhaustion, tiredness, and lack of energy (Aaronson et

al., 1999; Dittner, Wessely, & Brown, 2004;

Ream & Richardson, 1996). Similar to other

symptoms such as pain, fatigue is multidimen-

sional, is influenced by physical and psychoso- cial factors, and shares common features with

some mood and anxiety disorders (Aaronson et al., 1999; American Psychiatric Association,

2013). In patients with coronary heart disease (CHD), fatigue is a prevalent and debilitating symptom associated with poor quality of life and reduced physical activity (Pragodopol & Ryan, 2013). CHD, also referred to as

ischemic heart disease and acute coronary

syndrome (ACS), encompasses conditions that

arise because of atherosclerosis and a reduc-

tion in coronary artery blood flow (American Heart Association, 2013). Emerging evidence

indicates that new onset or elevated levels of fatigue may be associated with an impend- ing ACS event or may indicate worsening or

progressive CHD. Among patients (N = 256,

284 Reprinted with permission from Eckhardt, A. L., DeVon, H. A., Piano, M. R., Ryan, C. J., and Zerwic, J. J. (2014). Fatigue in the presence of coronary heart disease. Nursing Research, 63(2), 83-93.

APPENDIX F # —

mean age = 67 years) presenting to the emer-

gency department for ACS, patients reported

that “unusual fatigue” was one of the three most prevalent symptoms that propelled them

to seek care (DeVon, Ryan, Ochs, & Shapiro,

2008). In a large prospective longitudinal

study enrolling only men (N = 5,216, mean

age = 59 years), Ekmann, Osler, and Avlund

(2012) found that fatigue was associated with

first hospitalization for nonfatal ischemic

heart disease (hazard ratio [HR] = 1.98, 95%

CI [1.09, 3.61]) and all-cause mortality (HR

= 3.99, 95% CI (2.27, 7.02]). After adjusting

for smoking and alcohol consumption, fatigue remained the only significant predictor of first hospitalization for nonfatal ischemic heart disease in men. In a large study enrolling

women and men (N = 11,795, mean age =

57 years), Lindeberg, Rosvall, and Ostergren

(2012) found that exhaustion predicted car-

diac events in both men (HR = 1.49, 95% CI

{1.06, 2.11]) and women (HR = 1.78, 95% CI

[1.23, 2.58]). After adjusting for depression

and anxiety, the association between exhaus-

tion and CHD was strengthened in men (HR

= 1.62, 95% CI [1.05, 2.50]) but was no

longer statistically significant in women.

Fennessy et al. (2010) found that both

men and women reported moderate-to-high

levels of fatigue at the time of acute myo-

cardial infarction (AMI). Women reported significantly less fatigue 30 days after AMI, whereas men did not report a change. Using quantitative coronary artery angiography,

Zimmerman-Viehoff and colleagues (2013) examined the relationship between vital exhaustion (Maastricht questionnaire) and progression of coronary artery atherosclerosis in women (N = 103, mean age = SS years)

who had experienced an acute coronary event. Vital exhaustion significantly cor-

related with coronary artery diameter, with women having the highest vital exhaustion scores (46-57) showing the most pronounced

coronary artery diameter narrowing (M =

0.21 mm, 95% CI [0.15, 0.27]) compared

with intermediate vital exhaustion scores (43-45; coronary artery diameter, M = 0.11

mm, 95% CI [0.05, 0.17]). Women with

Reprinted

with permission.

Fatigue in the Presence of Coronary Heart Disease 285

vital exhaustion scores in low (score: 20-34)

and lower intermediate (score: 35-42) range

had no significant change in coronary artery

diameter. These findings indicate that women with the highest level of vital exhaustion had the fastest coronary artery atherosclerosis progression.

Considering that fatigue may be an indi-

cator of new onset or progressive CHD, it is

important to determine the severity and char- acteristics of fatigue in a stable CHD popula-

tion. Stable CHD is defined as patients who

have been diagnosed with CHD but have not experienced a worsening of symptoms, symp-

toms at rest, or an episode of ACS for at least

60 days (Goblirsch et al., 2013). Therefore,

the purpose of this partially mixed sequential dominant status study was to

1. describe fatigue (intensity, distress, tim-

ing, and quality) in patients with stable CHD;

2. determine if specific demographic (gender, age, education, income), physiological

(hypertension, hyperlipidemia), or psycho- logical (depressive symptoms) variables

were correlated with fatigue; and

3. determine if fatigue was associated with health-related quality of life (HRQoL).

@ Organizing Framework

The organizing framework for this study was derived from the theory of unpleasant symp-

toms, which includes physiological, psycholog-

ical, and situational factors that influence the

symptom experience and describes symptoms in terms of intensity, distress, timing, and

quality (Lenz, Pugh, Milligan, Gift, & Suppe, 1997). Although not consistent across all CHD studies, others have reported that fatigue is associated with gender, age, HRQoL,

medication type, smoking status, pain,

and depressed mood (DeVon et al., 2008;

Ekmann et al., 2012; Fink et al., 2012; Fink,

Sullivan, Zerwic, & Piano, 2009; Hagglund,

Boman, Stenlund, Lundman, & Brulin, 2008;

Generating and Assessing Evidence for Nursing Practice (11th ed.)

286 APPENDIXF

Physiologic

Co-morbid conditions

Hypertension

Diabetes

Medications

FSI Interference Scale

Qualitative interviews

Psychological

Depressed Mood

Influencing factors

Symptom Experience

Quality Intensity

Performance Quality of Life (SF-36) and functional status (interviews)

Fatigue in the Presence of Coronary Heart Disease

Situational

Age

Sex

Education

Income

FSI

Qualitative interviews

FSI severity scale

Qualitative interviews

Figure 1. Organizing framework based on the theory of unpleasant symptoms used to understand fatigue in

the presence of coronary heart disease.

McSweeney & Crane, 2000; Shaffer et al.,

2012). Figure 1 depicts the conceptualization

of the theory of unpleasant symptoms for the

current study as adapted by the authors.

In the theory of unpleasant symptoms, gen-

der and age are considered situational factors,

whereas depressed mood is categorized as a psychological factor. The symptom experience

was examined using the Fatigue Symptom

Inventory (FSI; Hann et al., 1998). The average

of the first three FSI questions was used to

evaluate symptom (fatigue) intensity. The

FSI-Interference Scale was used to determine

symptom (fatigue) distress. The distress dimen-

sion within the theory of unpleasant symptoms

refers to the degree to which a person is both- ered by the symptom and the symptom inter-

feres with activities of daily living. The FSI has

several items, which corresponded to the tim-

ing of fatigue (time of day, number of days per week fatigue occurs, and pattern of fatigue).

The Short Form-36 (McHorney, Ware, &

Raczek, 1993), a measure of HRQoL, was

Generating and Assessing Evidence for Nursing Practice (11th ed.)

used as a reflection of performance. Qualitative interviews were completed to obtain a compre- hensive description of fatigue and add descrip- tive depth to each of the dimensions within the

theory of unpleasant symptoms.

@ Methods

RESEARCH DESIGN

The study was conducted using a partially

mixed sequential dominant status design,

whereby the main study design was quantita-

tive (QUAN) followed by a qualitative (qual)

component (QUAN -= qual). In a partially

mixed sequential dominant status design,

the qualitative and quantitative elements are

deployed one after the other with one method being emphasized over the other (Leech &

Onwuegbuzie, 2009). This mixed-methods design was chosen to achieve complementarity,

Reprinted

with permission.

APPENDIX F = —

which seeks to achieve convergence between

quantitative and qualitative findings and to provide descriptive depth through qualitative interviews (Greene, 2007). The cross-sectional

quantitative data were collected first, and

participants for the qualitative component

were recruited from this sample. Integration of qualitative and quantitative data occurred at

the data analysis and discussion stages.

SAMPLE AND SETTING

One hundred and two participants with stable CHD were recruited from two cardi- ology clinics during routine cardiovascular appointments. One clinic served primarily

minority, urban patients (7 = 51), and one

served predominantly Caucasian patients from a small city in a rural setting (n = 51).

Eligibility was determined by review of

medical records. Inclusion criteria included a diagnosis of stable CHD, the ability to speak and read English and living independently. Exclusion criteria included heart failure with reduced ejection fraction (ejection fraction

<40%), terminal illness with prediction of less

than 6 months to live, myocardial infarction

or coronary artery bypass grafting in the

past 2 months, unstable angina, symptoms

due to worsening or exacerbation of cardiac disease, and hemodialysis. These exclusion

criteria were chosen to eliminate patients

with a recent acute event, those with new or

worsening symptoms of CHD, and those with

comorbid conditions known to be associated with significant fatigue. The institutional review boards at both sites approved the study. All participants provided written informed consent.

QUANTITATIVE MEASUREMENT

Fatigue. Fatigue was measured using the FSI,

a 14-item self-report instrument measuring fatigue intensity, duration, and interference with activities of daily living over the past week (Hann et al., 1998). The FSI has been

Reprinted

with permission.

Fatigue in the Presence of Coronary Heart Disease 287

used to measure fatigue in patients with AMI

(Fennessy et al., 2010; Fink et al., 2010) and

patients with heart failure (Fink et al., 2009).

Similar to others, the first three items of the

FSI were used to measure fatigue intensity/

severity (Donovan, Jacobsen, Small, Munster,

& Andrykowski, 2008). Questions 5-11,

which are referred to as the FSI-Interference

Scale, were used to measure the degree to which fatigue has interfered with patients’

daily activities in the past week. Each ques- tion on the FSI is answered using an 11-point Likert-type scale (0 = not at all fatigued/no interference to 10 = as fatigued as I could be/ extreme interference). Interference in physi-

cal, cognitive, and emotional aspects of daily living are measured using the interference

scale. Questions 1-3 and 5-11 were summed and then divided by the total number of

items (3 and 7, respectively) to generate the

intensity fatigue score and FSI-Interference

Scale score, yielding scores ranging from 0 to 10. Higher scores reflect higher intensity

of fatigue and more interference because

of fatigue. The FSI-Interference Scale has excellent reliability as estimated by coefficient alphas ranging from 0.93 to 0.95 (Hann,

Denniston, & Baker, 2000; Hann et al.,

1998). Using the SF-36 vitality subscale as a comparison, Donovan et al. determined

that an intensity score of >3 was reflective of

clinically meaningful fatigue. In the current

sample, reliability was strong for the FSI-

Interference Scale (a = 0.93) and the FSI

intensity score (« = 0.86).

Depressive Symptoms. Depressive symp-

toms were measured using the Patient Health

Questionnaire-9 (PHQ-9), which has been

used in prior studies with cardiovascular

patients (Fink et al., 2012; Lee, Lennie, Heo,

& Moser, 2012). The PHQ is a nine-item

self-report instrument with a 4-point Likert-

type scale (0 = not at all; 1 = several days; 2 = more than half the days; 3 = nearly every day)

for each question and was developed using the Diagnostic and Statistical Manual for

Mental Disorders’ criteria for major depres- sion (American Psychiatric Association, 2013;

Generating and Assessing Evidence for Nursing Practice (11th ed.)

288 APPENDIXF

Kroenke, Spitzer, & Williams, 2001). Scores

of >10 indicate moderate/severe depressive

symptoms; scores between 5 and 9 indicate

minor depression. Using a structured mental

health professional interview as the criterion

standard, the sensitivity and specificity of the

PHQ-9 (score >10) was 88% for detecting major de-pression (Kroenke et al., 2001). In

this study, a score of >5 was used as the cutoff

for the presence of depressive symptoms.

HROoL. HRQoL includes physical and mental health perceptions of positive and

negative aspects of life (Centers for Diséase

Control and Prevention, 2012). The SF-36

has been extensively used to measure HRQoL

and has established reliability and validity

in numerous populations (McHorney et al.,

1993), including CHD populations (Fink et

al., 2009; Hagglund et al., 2008). The SF-36

is a 36-item questionnaire that consists of eight subscales designed to measure quality

of life in the domains of physical and mental

functioning. The eight subscales are physical

functioning, physical role limitation, emo-

tional role limitation, vitality, mental health,

social functioning, pain, and general health. The SF-36 generates eight subscale scores and

two summary scores (physical component

score and mental component score). Raw scores are standardized to range from 0 to

100, with lower scores indicating a lower

level of functioning. Within the current study, reliability was good (a = .79-.88) for seven of

the eight subscales, with a lower reliability for

the general health subscale (a = .69).

QUANTITATIVE ANALYSIS

Data were analyzed using the Statistical

Package for the Social Sciences (Statistics for

Windows, Version 19.0, IBM, Armonk, NY).

A nominal alpha level of <.05 was designated

for statistical significance. Chi-squared tests for independence and independent samples t tests were used to analyze demographic data

and fatigue stratified by gender. Pearson’s

correlation and Spearman’s rho were used

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Fatigue in the Presence of Coronary Heart Disease

to identify factors associated with fatigue. Multiple regression was used to identify pre-

dictors of fatigue.

QUALITATIVE MEASUREMENT

Using scores from the FSI-Interference Scale, participants were identified as experiencing

high (>2.5), moderate (1.15-2.4), or low

(1.14) levels of interference from fatigue (Fink

et al., 2010). Participants from each fatigue level were selected for the qualitative inter- view. Participants for the qualitative arm were

interviewed within 3-5 weeks of enrollment.

This time frame was selected to prevent potential recall bias and reduce the likelihood of participants experiencing cardiovascu-

lar events. Purposive sampling was used to

achieve heterogeneity of the sample and to increase transferability of findings.

The principal investigator or research

assistant completed all interviews, which lasted approximately 30 minutes. The

principal investigator reviewed interviews

completed by the research assistant to

ensure consistency between interviewers. A

semistructured interview guide was used to

collect data. Questions included, “Describe a typical day,” “What time of day do you feel most fatigued?” and “Describe your

fatigue.” Additional questions and probes

were used to enhance the quality of the data.

Field notes and an audit trail were main- tained throughout data collection to ensure

confirmability. Data saturation was reached after completing 13 interviews.

QUALITATIVE ANALYSIS

Interviews were digitally recorded and tran-

scribed verbatim. Transcripts were imported

into NVivo 9 (QSR International, Burlington,

MA) for coding and analysis. Transcripts were reviewed for accuracy by checking transcripts against the digitally recorded

interview. Narrative analysis, which considers the potential for stories to give meaning to the

Reprinted

with permission.

APPENDIX F pon

data (Onwuegbuzie & Combs, 2010), was

used as the primary analytic technique. Using the theory of unpleasant symptoms; themes

of situational, psychological, and physiolog- ical factors; symptom description (timing, intensity, distress, quality); and performance

(HRQoL) were analyzed. As data were coded,

emerging themes were added, including an

overall definition of fatigue, the worst part of being fatigued and aggravating/alleviating fac-

tors. To avoid biasing results, interviews were initially analyzed without regard to fatigue group. After all interview analyses were

complete, within- and between-group analyses were done by comparing interviews from each

group to determine similarities and differences between groups.

MIXED-METHODS ANALYSIS

After qualitative and quantitative analy-

ses were complete, data were compared to

determine patterns, enhance description, and

address any discrepancies. Qualitative data

were used to expand the overall depth of quantitative findings and provide a more thor- ough description of fatigue. If discrepancies

were found, the authors reviewed discrepant data to determine if narrative data were reveal-

ing a concept not included on the standard

instruments. Discrepancies in mixed-methods

findings are generative, as they lead to fur-

ther analysis and future research directions

(Greene, 2007).

@ Results

DEMOGRAPHIC CHARACTERISTICS

The mean age of participants (N = 102)

was 65 years (SD = 11 years, range:

34-86 years). Most were men, non-Hispanic

White, married, and had a high school

education or greater (Table 1). The quali-

tative sample included nine men and four

women (mean age = 67 years, SD = 12

Reprinted

with permission.

Fatigue in the Presence of Coronary Heart Disease 289

years, range: 50-85 years); five participants

reported low interference from fatigue, four

reported moderate interference, and four reported high interference (Table 1).

FATIGUE INTENSITY/SEVERITY

Quantitative Analysis. Women reported

significantly higher levels of fatigue intensity (M = 4.38, SD = 2.16) than men (M = 3.43, SD = 2:16; t = 2.27, p = .003). Fifty-seven

percent of men and 78.4% of women had clinically meaningful fatigue as indicated by

an intensity score of >3. Fatigue intensity

was significantly correlated with PHQ-9

score, smoking history, and income (Table 2).

In a regression model, PHQ-9 (depressive

symptoms) was the only predictor of fatigue intensity (Table 3).

Qualitative Analysis. Participants in

the qualitative arm of the study reported

varying degrees of fatigue intensity. Some

participants reported not recognizing fatigue

until they “hit a wall” and did not want to

do anything else. Others reported noticing a change from the past, stating, “I’d be able to doze off sitting up. I didn’t used to

be able to do that” (58-year-old woman,

low fatigue interference) and “I’m more

tireder (sic) this year than I was a year ago”

(50-year-old man, high fatigue interference). One participant mentioned that she noticed

an overall slowing down, “since I was sick.” Most participants indicated a general slow-

ing down but could not relate the change to any specific event. Of note, one partic-

ipant stated, “I just get tired. Some days I almost start crawling” (81-year-old man, low fatigue interference). This participant

reported no interference from fatigue (score

of 0 on FSI-Interference Scale), rated his

worst fatigue severity as a 4 on an 11-point

Likert scale, and consistently scored 250 (range: 0-100) on all HRQoL subscales.

This incongruent finding may represent

an accommodation to decreased physical

capacity because of CHD.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

290 APPENDIXF & Fatigue in the Presence of Coronary Heart Disease

Table 1 Demographic and Clinical Characteristics of the Sample

Total Sample Qualitative (N= 102) Sample (n= 13)

Variable N %o n %

Gender

Men 65 63.7 9 69.2

Women 37 36.3 4 30.8

Race/ethnicity

Non-Hispanic White \sy7/ 55:9 9 69.2

Black 36 35.3 4 30.8

Hispanic ; 4 S19 0 0

Asian 2 2.0 0 0

Other 3 7288) 0) 0

Marital status

Married/long-term committed 60 58.8 10 76.9

Divorced/separated 23 2225 1 Voll

Widowed 10 9.8 2 15.4

Single g 8.8 0 0

Education

Less than 12 years 17 16.8 2 15.4

High school dipioma 38 37.3 4 30.8

Some college/associate degree 20 19.6 3 He),

Baccalaureate degree 13 27, 3 Sal

Graduate degree ue) 27, 1 eh

Employment

Full/part-time work 27 26.5 5 38.5

Retired 5S 52.0 6 46.2

Disabled/unemployed/medical leave 18 17.6 1 Trdl

Homemaker 2 2.0 0 0

Comorbid conditions

Type 2 diabetes 40 CZ 5 38.5

Depression 12 11.8 2 15.4

Hypertension 91 89.2 11 84.6

Hyperlipidemia 95 93a 12 S28}

Prior myocardial infarction 34 33.3 4 30.8

Prior percutaneous coronary intervention 79 HHS) 11 84.6

Prior coronary artery bypass graft 24 PGS) 3 23h

Medications

Aspirin 88 86.3 13 100 Ace inhibitor 60 58.8 9 69.2

Beta blocker 7/5) UES) 11 84.6 Lipid-lowering agent 88 86.3 13 100

APPENDIX F wo

Fatigue in the Presence of Coronary Heart Disease 291

Table 2 Correlations: Fatigue Intensity and Interference With Demographic and Clinical Variables rr

Fatigue Intensity Fatigue Interference

Variable r p r p

Age —.08 43 —.24 02

Gender .24 .02 22 .02

PHQ-9 (depressive symptoms) .56 <.0001 66 <.0001

Income —.20 05 —.16 12

Race .09 39 .09 37

Education —.16 IZ —.16 12

Smoking history .20 05 19 06

Diabetes .00 99 —.03 76

Hypertension —.02 82 —.13 21

Myocardial infarction —.13 19 —.04 .67

PCI 04 Al 02 81

Coronary artery bypass graft .06 .540 01 8}

Note. PHQ = Patient Health Questionnaire; PCI = percutaneous coronary intervention.

Table 3 Regression of Fatigue Intensity on Gender, Age, Income, History of Smoking, and Depressive Symptoms

Model Predictors b t p

1 Gender OS Oxo x4)

Income LO OF 07, ME

History of .04 0.41 .68

smoking

PHQ-9 554 5.80 <.0001

2 Gender .05 0.60 .55

Age 03 0.38 70

PHQ-9 Bs Bil q{ololon

Note. PHQ = Patient Health Questionnaire. Model 1 variables were those correlated with fatigue inten- sity; R* = .32, adjusted R? = .30, SE = 1.73, Fy, 99 = 22.92, and p < .0001. Model 2 variables were those

hypothesized to be related to fatigue intensity; R* = .32, adjusted R* = .30, SE = 1.74, Fs, 96 = 15.20, and p < .0001.

Reprinted

with permission.

FATIGUE INTERFERENCE

Quantitative Analysis. Women reported

significantly more interference from fatigue CME = SASSO) = ZirS 270 = L007)

than men (M = 1.99, SD = 2.03). The FSI-

Interference Scale score was significantly cor-

related with age and PHQ-9 score (Table 2).

Depressive symptoms were the only predictor of interference from fatigue in a regression

model (Table 4).

Qualitative Analysis. A common theme

was a general slowing down. “I have like a certain amount of energy in my bank account in the morning, and it just kind of

gradually depletes during the day, and when

it’s gone, it’s gone” (62-year-old man, mod- erate fatigue interference). Other participants

reported rearranging their activities around

the time of worst fatigue. “Then I arrange my day so that I can take my walk, come

Generating and Assessing Evidence for Nursing Practice (11th ed.)

292 APPENDIXF

Table 4 Regression of Fatigue Interference on Gender, Age, and Depressive Symptoms

Model Predictors b t p

1 Gender AO7/ 0.90 Foy,

Age —.12 —-1.54 mls

PHO-9 61 7.56 <.0001

2 Gender .07 0.90 <SY/

Age -—.12 —-1.54 mills

PHO-9 61 7.56 <.0001

Note. PHQ = Patient Health Questionnaire. Model 1 variables were those correlated with fatigue interfer- ence; R* = .46, adjusted R? = .43, SE = 12.49, Fs, o¢ = 16.07, and p < .0001. Model 2 variables were those

hypothesized to be related to fatigue interference; R? = .45, adjusted R? = .42, SE = 12.59, Fs, 99 = 19.60, and p < .0001.

back and take a nap, and be fresh for the appointment. And that’s the way I handle it”

(81-year-old woman, high fatigue interfer-

ence). Other descriptors of symptom distress included: “I remember I taught Grapes of

Wrath. And ma would say, ‘I’m sick tired,’

you know...

You’re almost sick, you’re so tired”

(74-year-old woman, moderate fatigue inter-

ference). Some participants described their

distress in terms of activity, “like you want to lie down and take a nap” (50-year-old man,

moderate fatigue interference). Participants

who reported the lowest FSI-Interference Scale scores reported fewer instances of daily fatigue but still reported having days when they were exhausted.

TIMING OF FATIGUE

Quantitative Results. Fatigue intensity

was significantly correlated with the number

of days per week participants experienced

fatigue (r = .63, p < .0001) and the portion of the day participants felt fatigue (r = .66, p <.0001). Participants reported being fatigued

a mean of 3.43 (SD = 2.38) days per week.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Fatigue in the Presence of Coronary Heart Disease

Qualitative Results. Reports of the tim- ing of fatigue varied. Some people reported fatigue every day at the same time: “Here

lately it’s been pretty much every day.... I get

up and get [spouse] out to work...it feels like I’m drained” (85-year-old man, high fatigue interference). Other participants reported that

fatigue only affected them after being busy and finally sitting down for the day, whereas some stated that there was no pattern. Two participants reported no fatigue on their

quantitative measures, but they reported

slowing down and needing more frequent

breaks. One participant reported, “I take a nap...but as far as fatigue; I’ve got a lot of energy” (53-year-old man, low fatigue interference). Participants often did not relate slowing down, taking more frequent breaks,

or needing naps to fatigue.

QUALITY OF FATIGUE

Qualitative Analysis. The quality dimen-

sion of the theory of unpleasant symptoms

refers to the symptom description, how the

symptom manifests, or alleviating factors. Descriptors of fatigue included “I get winded a lot quicker,” “going at a slower pace,”

and “a little aggravated and drained.”

Participants often reported that sitting down

and resting was an alleviating factor. Many participants reported that simply going

slower was helpful, “so instead of working

three hours, I should work two and then

leave it” (79-year-old woman, low fatigue interference).

All participants in the qualitative arm were

asked to define fatigue. Definitions included “being completely wore (sic) out,” “different

kind of fatigue,” “bone weary,” and “low

energy, low mental processing.” Participants often described it as being different than the feeling after a long day at work, “I’ve done

a hard day’s work before and not quite feel, wouldn’t be the same.... I really don’t know how to explain it...just more or less completely

exhausted” (85-year-old man, high fatigue interference). Although the descriptions and

Reprinted

with permission.

APPENDIX F ~

definitions varied, it was obvious that fatigue was a physically and mentally taxing symptom that was affecting the individuals’ daily lives. Definitions of fatigue did not vary whether participants experienced high, moderate, or low interference from fatigue.

HROoL AND FATIGUE

Quantitative Analysis. Fatigue intensity

and interference from fatigue were negatively

correlated with each of the SF-36 subscales

that measure HRQoL (Table 5). Participants who reported more fatigue intensity and more

interference from fatigue reported significantly worse scores on all eight subscales.

Qualitative Analysis. Overall, participants reported that fatigue did not affect their

enjoyment of life. Some participants reported

feelings of jealousy when they saw people who were older doing things more easily than they could themselves: “I get jealous. Sometimes

Table 5 Correlations: Fatigue Intensity and Interference With Health-Related Quality of Life

HR-QoL? Fatigue Fatigue Intensity Interference

Physical —.54* —.60*

functioning

Role limitation —.50* —.54*

physical

Role limitation —.44* —.53*

emotional

Vitality —.65* —./5*

Mental health —.47* —.60*

Social functioning -—.55* —.65*

Pain —.51* —.52*

General health —.53* —.66*

Note. HR-QoL = health-related quality of life. 4HR-QoL variables are subscales from the SF-36.

prea Oille

Reprinted

with permission.

Fatigue in the Presence of Coronary Heart Disease 293

I'll see people in their 70s and 80s, and they’re walking fast, like there’s nothing wrong with

them. They’re full of piss and vinegar. It’s like,

‘wow I’m only 52’” (52-year old-man, high

fatigue interference). Others reported finding ways to adapt to the fatigue by “uncon- sciously” planning their outings around times of worst fatigue.

# Integrated Analysis

There was concordance of findings between

quantitative and qualitative measures on timing and distress dimensions of the theory

of unpleasant symptoms. Table 6 summarizes the integrated analysis.

Participants with the highest FSI- Interference Scale scores tended to report the most difficulty with fatigue during quali- tative interviews, with one exception: An 81-year-old man categorized as having low fatigue interference reported high fatigue

during the interview. On the day of his interview, he reported he was “feeling pretty

good” but described how bad he felt on his high fatigue days. It is possible that, when he completed the FSI, he was having a good day and did not answer the questions based on how he felt at any time other than the present.

Although participants during the qualita-

tive interviews did not always acknowledge fatigue, they reported a general slowing, an

increased frequency of breaks, and an overall tailoring of their lifestyle to avoid fatigue. All

interviewed participants who reported low

fatigue interference (7 = 5) reported needing additional breaks. Neither the FSI fatigue severity score or interference score captured this phenomenon; therefore, without the addi-

tion of the qualitative component, important information might have been lost. The use of

a partially mixed sequential dominant status design in which qualitative data enhance

and expand data acquired through validated quantitative tools provided a deeper and

contextualized picture of fatigue in patients

with CHD.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Fatigue in the Presence of Coronary Heart Disease APPENDIX F

‘ w o j d w A s

ay }

41 0}

B u i e s u e d w o o ai

e sj ua ii ed

au IW WI a} ap

an bi je }

In og e

su ol se an b

pa yi ey ep

B I O L

JS C

P9 9B U

SI BP IA OD Ig

‘p ay io da i

G H D

8/ 9e 1s

Y U M

sj ua

lj ed

e y

Bu io jl e}

aj Aj sa ji )

ay }

ai ny de o

pa le }

SJ Us WN II SU !

PI EP UL IS

“o pl |

Aj le

p Bu

lj oa

o n b r e y

p9 8} 0U

S] Ue LU NI }s U!

pe zi ps ep ue }s uo

an bi

je }

Mo }

p e i o d a s

O Y M

sj ue di oi ie d

as ou }

Ud AZ Q

$} ]/ NS OJ

B A I W e N J U e N b

a A j e y j e n b

p a y i u a p !

an bi je j

u s a y e d

J U a s I s u O D

O N

e , A e p

Ai an a, ,

,, AB J9 Ua

$1 0}

YO Ns

S ] U S W U W W O D

B A I } e U e n b

Y U M

pe je je 44 10 9

an bi je }

A d u a n b e a .

s u o d a l

a n i j e y u e n D

(a nB

iy ey

a y e s a p o w )

, B u i s s e s e q u w e a

S |

p u y

{A eu }

pi p

‘a u

me s

A p o g o y

"* *

f o

B u l p p o u

jy as Aw

p u

|, ,

(e nb iy ey

mo j)

,, "

* +} ,U e9

no A

yn o

pu lj

NO A

ua y}

pu e

°° ‘a an oe

a J O W

B W 0 9 9 q

AJ }

Bu lo b

w. ,|

M O U

pu ke

“J 9U IO D

e pa us n}

Aj je ul y

pe y

UO !I

pP UO

d je dI pe l

A W

e u }

32 }

(a nb

ij ze

yB iy )

“S ev er

“a W}

Ul e4 ao

$1 ),

(a nB ye }

a3 e1 49 p0 W)

, p u n o s e

B u l A o w

pu e

‘d n

Bu ij eb

‘B ul op

Ww ]

y e y M

Bu id do js

pu a

aa ey

je ns

n |

p u y

‘ B u l u s o w

9u }

uy ,

(e nB bn ey

a y e s a p o w )

°°

ss Bu iu an e

SJ OW

S$ }!

BU I}

BY }

Js OW

W 1N g

“i q

81 11 ]

e JO

f u M O p

Ae ]

||, |

PU L

‘p ai

a j ]

2 18

6 ||

‘Y UO OU ay e

8y }

Sa WU I} OW OS

°° *,

(a nb iy e4

MO })

, A e p

As an a

u a d d e y

}, uo p

°°

(e nB ie y

mo j)

, -A Bs au a

}0 |

€ 10 6

a n

‘a nB iy ye y

se y

s e :

(e nB iy ey

yB iu )

,. °

* “A ep

Ai sn e

yo nu w

Aj yj

ai d

u s e q

$, }!

aj e]

8 4 9 1 ,

"9 ]€

1] U9

DU OD

Ay lj ig e

pu e

sd iy su oi ne ja s

U U M

ao Ud

I9 J1

9} U!

p e v o d a s

1 4 8 A

‘ p o o w

pu e

‘a ji |

J u a w W A O l u a ‘A

UA I} OR

Y I O M

J E W I O U

Y U M

pa so ji aj ul

an Bi

ze y

ye y)

pe vi

od es

Aj Je an

AV AI }N e

je 49 ue b

Y U M

pa ra pa qu l

an bi je y

pa yi od as

Y Z

us ay je d

ju a}

si su

p e y o d a l

%E ez

B u l u a A d

dy }

B S I O M

an bi ye }

p a y o d a i

% e z

UO OU IJ AY e

9 }

B S I O M

an bi

je y

p a y o d a s

%1 .Z

Bu lu sj OW

9 }

B s I O M

en bi je }y

p e y o d a s

% Q z

4 9 e m j s e d

au }

S A e p

an bi

je y

po wi od as

% e v

8 9 M

Is ed

au }

s A e p

€- L

en bi

je y

pa yi od as

% / p

8 9 8 M

s e d

du }

an bi

1e ,

p a y o d a s

% 9 ' ¢

ss ai 1s iq

uj al je d pu

e A o u e n b a l y

Reprinted

with permission.

Nursing Research:

294

si sk je uy

pa ye sb aj uy

(1 99 ]a S)

Be g

S A H e e N D

(} 98

]9 g)

eJ eq

aA He nU eN D

uo ls ua Wg

an in ey

_ _

C O

r a

—

si sh je uy

ey eq

pa je sf ia qu y

9 aj qe y

295 Fatigue in the Presence of Coronary Heart Disease APPENDIX F

‘g0uUdIIadxa

Asay} s w o y d w a A s au}

A q peje}01p

aq 0}

a4!) $0

Ayijenb m o j e you

pue awl}

JaA0 Ajloedeo

jeuolnouny

p e s e a i s e p

e 0} }Jdepe

G H D ajqels

U]IM sjudijed

jeu} s i e o d d e

“paal| Aay}

24! fo

A y y e n b ay}

a}e}01p 0}

e n b y e 4

Mojje }0U

pip pue

p a y d e p e Aau}

jeu} p o y o d a i sjualjed

‘||e49AQ SUOIJOIISOI

ajepoOwwodIe

ajAjSaj}I|

BuiBueyo

pue

anbije}

Buyjdepe

syiodai

aAijeyenb

uajsisuog

‘sdnoib

anbije}

MO]

pue

‘a]}e19pOW

‘uBiy

usaemjoq

AjjuedyiuBbis

J a p

JOU pip

Ajyisuequl

anBije} Jo

s u o d a s anijeyjenoO

anbije} j n j 6 u i u e e w

Ajjediuljo 4O

aAijeoipul Ajisuejul

anBiyey a B e s a n e jo

B u n e y

(anbiyey

MO})

,,,491Se9

1O|

H u l o B fo

uoljOU By}

4O 1NO

Jeb ued

(anbiyej yBiy)

,, Gurop aq

0} pasn

noA }eYyM

W O U M O P

ynyus Buleq:

* ‘aww

ay!) $,}ey}

A n B

uo sapsey ay} SJeYM

Sey} AUIYD

|, (anBnes

yB1y) ,, seppe|

e uO ssaulsng

OU 306

j,uUILe NOA

‘paily

Buljae} a4,noA

u a y m :

* “auop

31 386

},UOp ysnf yng

‘Op 0}

jo] e 106

aA |,,

(anbije}, 9 3 e 1 9 p O W )

y t ydaooe

0} used]

ysn[ n o A : * ' ,

(anbiye} a}e49p0wW)

,,}NO YU Yd}843S

JO puly

ysn[ NOA

M O N

‘auop 11 196

pue a u o p B u l y j e w o s

196 pue

a19u} ul

Bulob w y ,

(anBiyey moj)

d n

noA B u i d e a y w e d ay}

uO H u l b u e y

pue 3no

06 0}

BulAyy * “ j u n panbiyey

3 1 9 M NOA

9z1je94 1,UOp

NOA:**,,

(an6Bize4 uBiy)

,,“alu yOu

si Ajjensn

jeu} p u e ‘pail}

jnJme U Z 9 q

8AI,,

"sajeosqns 9¢-4S

9uU} $O |Je U

M peyejas09

9JAM S81ONS

| S

‘ayl] Jo

Ayyjenb samo] p

a y o d a s

aj1sodwosd |S4

ay} Buisn

anbize} ybiy

se paljissejo

sjuedinived

(OL-0 :aBues)

anbijey sea]

Buljes ay}

UO ( P L °Z =

dS) ZL'z

40 a109s u e s

(OL-0 :oBues)

anbijey a B e s a A e

$O Buljes

ay} UO ( 7

GS) LZ'€

$0 a400s

Uea|\|

(OL-0 :e6uel)

anbije} s o w

Jo Buljyes

ay} UO

(p~9'Z =

CS) vr'g

$0 a109s u e s

(a4!] 0 Ayjenb

paze}a4-yijeau)

SOURLWIOHad Ajisuaju|

ters Kluwer. Polit & Beck: Resource Manual for Nursing Research:

with permission.

296 APPENDIXF

= Discussion

A key finding of the study was that more than

50% of stable male and female participants with CHD reported clinically meaningful fatigue that occurred on an average of 3.43

days of the week. This indicates that patients with stable CHD experience a high degree

of fatigue. Women (M = 3.28, SD = 2.71),

but not men (M = 1.99, SD = 2.03), reported

higher interference with activities because of fatigue than those reported by cancer patients

under-going active treatment (M = 2.3, SD = 2.2; Hann et al., 1998) and patients with

reduced ejection fraction heart failure (M =

DOSS D = 2.7. Fink e@al., 2009): The presence of depressive symptoms was

the only predictor of fatigue intensity and interference among the potential contribu-

tors to fatigue. Interestingly, in the univariate

analysis, women reported significantly greater

fatigue intensity and interference compared

with men; however, after controlling for

depressive symptoms, there were no gender dif-

ferences, indicating that depressed mood was

a dominant factor. Finally, fatigue intensity

and interference were correlated with poor

HRQOL. Patients with higher PHQ-9 scores (depressive symptoms) reported more interfer-

ence from fatigue and fatigue intensity. On the basis of the regression analysis, 45% of fatigue

interference scores were explained by the pres-

ence of depressive symptoms. Even participants categorized as having mild depressive symp-

toms reported higher levels of fatigue. The link

between fatigue and depression has been docu- mented in patients with cardiovascular disease

(Evangelista et al., 2008; Fennessy et al., 2010;

Fink et al., 2012). Others have also indicated a

strong relationship between fatigue and depres-

sion among patients attending primary care

clinics. Skapinakis, Lewis, and Mavreas (2004)

conducted a secondary analysis of data from

the World Health Organization longitudinal collaborative study of psychological prob- lems in general healthcare. Individuals with

depression at baseline were 4 times more likely

to develop new unexplained fatigue at the

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Fatigue in the Presence of Coronary Heart Disease

12-month follow-up. In patients with cardio- vascular disease, depressed mood or depression often coexist, and it remains to be determined

if depression is the cause or consequence of

fatigue. Younger age was associated with higher

fatigue interference but not fatigue intensity. It is possible that younger individuals find

that fatigue interferes with daily activities, whereas older individuals are not as active or

adapt more readily to fatigue by altering their activities. Kop, Appels, Mendes de Leon, and

Bar (1996) found that younger age and female gender were significant predictors of vital exhaustion in patients with CHD.

Similar to others, fatigue intensity and fatigue interference were negatively correlated with all eight SF-36 subscales (HRQoL).

Pragodpol and Ryan (2013) examined 17 studies and found that fatigue was a predic- tor of diminished HRQoL in patients with newly diagnosed CHD. In another study of patients with confirmed CHD and chronic angina, a symptom cluster containing fatigue,

dyspnea, and chest pain frequency was found to be predictive of lower HRQoL (Kimble et al., 2011). Staniute, Bunevicius, Brozaitiene,

and Bunevicius (2013) determined that poor HRQoL was associated with greater fatigue and reduced exercise capacity independent

of mental health and severity of CHD. The

findings validate the critical impact that the symptom of fatigue has on HRQoL.

All qualitative participants who reported

low interference from fatigue on their

standardized instruments (7 = 5) reported fatigue during the interview. These individ- uals reported low levels of fatigue interfer- ence and severity but described not doing as much, tailoring their lifestyle to prevent fatigue, and moving at a slower pace.

Lifestyle alterations in response to fatigue

have been described in the heart failure literature (Jones, McDermott, Nowels,

Matlock, & Bekelman, 2012). In an interpre-

tive study of 26 patients with heart failure, emergent themes included descriptions of patients adapting to being tired and identi- fying ways to proactively prevent fatigue by

Reprinted with permission.

- APPENDIX F

rescheduling their days (Jones et al., 2012). This adaptation may also have occurred with

patients in this study. It remains unknown if measurement error or other factors explain

differences between quantitative and qualita- tive reports of fatigue in this study.

STRENGTHS AND LIMITATIONS

Although previous research has focused on determining if fatigue predicts CHD in healthy individuals and the prevalence of fatigue before and after AMI, this is the

first study that specifically describes fatigue in a stable CHD population. This study is innovative in that the design included the use of mixed methods, which combined validated

quantitative measures with in-depth quali- tative interviews. The qualitative interviews

complemented findings from the quantitative instruments and added rich descriptive details to the findings. Sampling an urban and rural population resulted in ethnic and geographic diversity, thus increasing the generalizability

of findings. There were limitations to this study including the use of a convenience sample and the potential inclusion of patients

with undiagnosed heart failure. Differences in reports of fatigue intensity between standard- ized instruments and interviews in the low

fatigue group may indicate that the FSI- interference Scale is not as sensitive in individ- uals with lower interference from fatigue.

CONCLUSION

Fatigue was common in patients with stable

CHD. Women experienced a greater burden

from fatigue compared with men, and this was primarily because of the contribution of depressive symptoms. The use of mixed meth- ods was beneficial to the study of fatigue in stable CHD and provided additional insight, especially in participants who reported low

interference from fatigue. This study provides an important contri-

bution to understanding fatigue as a possible

Reprinted

with permission.

Fatigue in the Presence of Coronary Heart Disease 297

symptom of stable CHD; however, these descriptive findings preclude determining

if fatigue is an indicator of new onset or

progressive CHD. Future research is needed to establish the mechanisms of fatigue in this population. In addition, longitudinal studies are essential to understand causal relation- ships between depression and fatigue. Further study is also needed to examine the effective- ness of interventions on reducing fatigue to

improve HRQoL in patients with stable CHD.

Ann L. Eckhardt, PhD, RN, is Assistant Professor,

School of Nursing, Illinois Wesleyan University, Bloomington.

Holli A. DeVon, PhD, RN, is Associate Professor;

Mariann R. Piano, PhD, RN, is Professor and

Department Head; Catherine J. Ryan, PhD,

RN, is Clinical Assistant Professor; and Julie J.

Zerwic, PhD, RN, is Professor and Executive

Associate Dean, Department of Biobehavioral

Health Science, College of Nursing, University of

Illinois at Chicago.

DOI: 10.1097/NNR.0000000000000019

Accepted for publication November 12, 2013.

The authors acknowledge that this research was supported in part by grants from the

Midwest Nursing Research Society and

Sigma Theta Tau International.

The authors have no conflicts of interest to

disclose. Corresponding author: Ann L. Eckhardt, PhD,

RN, School of Nursing, Illinois Wesleyan

University, P.O. Box 2900, Bloomington,

IL 61702 (e-mail: [email protected]).

REFERENCES Aaronson, L. S., Teel, C. $., Cassmeyer, V., Neuberger,

G. B., Pallikkathayil, L., Pierce, J., & Wingate, A. (1999). Defining and measuring fatigue. Image: The

Journal of Nursing Scholarship, 31, 45-50. American Heart Association. (2013). Coronary artery

disease. Retrieved from http://www.heart.org/ HEARTORG/Conditions/More/MyHeartandStroke News/Coronary-Artery-Disease—The-ABCs-of-

CAD_UCM_436416_Article.jsp

American Psychiatric Association. (2013). Diagnostic

and statistical manual of mental disorders (Sth ed.).

Arlington, VA: American Psychiatric Publishing.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

298 APPENDIXF #® Fatigue in the Presence of Coronary Heart Disease

Centers for Disease Control and Prevention. (2012). Hogglund, L., Boman, K., Stenlund, H., Lundman,

Health-related quality of life (HRQoL). Retrieved B., & Brunlin, C. (2008). Factors related to fatigue

from http://www.cde.gov/hrqol/. among older patients with heart failure in primary DeVon, H. A., Ryan, C. J., Ochs, A. L., & Shapiro, health care. International Journal of Older People

M. (2008). Symptoms across the continuum of acute Nursing, 3, 96-103. coronary syndromes: Differences between women Hann, D. M. vDenniston, M. M., & Baker, F. and men. American Journal of Critical Care, 17, (2000). Measurement of fatigue in cancer pa-

14-24. tients: Further validation of the fatigue symptom

Dittner, A. J., Wessely, S. C., & Brown, R. G. (2004). inventory. Quality of Life Research, 9, 847-854.

The assessment of fatigue: A practical guide for doi:10.1023/A:1008900413113 clinicians and researchers. Journal of Psychoso- Hann, D. M., Jacobsen, P. B., Azzarello, L. M., Mar- matic Research, 56, 157-170. doi:10.1016/S0022- tin, S. C., Curran, S. L., Fields, K. K., ... Lyman, G.

3999(03)00371-4 (1998). Measurement of fatigue in cancer patients:

Donovan, K. A., Jacobsen, P. B., Small, B. J., Munster, Development and validation of the Fatigue Symptom

P.N., & Andrykowski, M. A. (2008). Identify- Inventory. Quality of Life Research, 7, 301-310. ing clinically meaningful fatigue with the fatigue doi:10.1023/A:1024929829627 symptom inventory. Journal of Pain and Symptom Jones, J., McDermott, C. M., Nowels, C. T., Mat-

Management, 36, 480-487. doi:10.1016/}.jpainsym- lock, D. D., & Bekelman, D. B. (2012). The

man.2007.11.013 experience of fatigue as a distressing symptom of Ekmann, A., Osler, M., & Avlund, K. (2012). The heart failure. Heart @& Lung: The Journal of Acute

predictive value of fatigue for nonfatal ischemic and Critical Care, 41, 484-491. doi:10.1016/. heart disease and all-cause mortality. Psychoso- hrtlng.2012.04.004 matic Medicine, 74, 464-470. doi:10.1097/PSY Kimble, L. P., Dunbar, S. B. vWeintraub, W. S.,

0b013e318258d294 McGuire, D. B., Manzo, S. F., & Strickland, O. L.

Evangelista, L. S., Moser, D. K., Westlake, C., Pike, N., (2011). Symptom clusters and health-related quality

Ter-Galstanyan, A., & Dracup, K. (2008). Correlates of life in people with chronic stable angina. Journal of fatigue in patients with heart failure. Progress in of Advanced Nursing, 67, 1000-1011. doi:10.1111/ Cardiovascular Nursing, 23, 12-17.doi:10.1111/ j.1365-2648.2010.05564.x j.1751-7117.2008.07275.x Kop, W. J., Appels, A. P. W. M., Mendes de Leon, C.

Fennessy, M. M., Fink, A. M., Eckhardt, A. L., Jones, F., & Bar, F. W. (1996). The relationship between J., Kruse, D. K., VanderZwan, K. J., ... Zerwic, J. J. severity of coronary artery disease and vital ex-

(2010). Gender differences in fatigue associated with haustion. Journal of Psychosomatic Research, 40, acute myocardial infarction. Journal of Cardiopul- 397-405. monary Rehabilitation and Prevention, 30, 224-230. Kroenke, K., Spitzer, R. L., & Williams, J. B. W.

doi:10.1097/HCR.0b013e3181d0c493 (2001). The PHQ-9: Validity of a brief depres- Fink, A. M., Eckhardt, A. L., Fennessy, M. M., Jones, sion severity measure. Journal of General Internal

J., Kruse, D., VanderZwan, K. J., ... Zerwic, J. J. Medicine, 16, 606-613. doi:10.1046/j.1525-- (2010). Psychometric properties of three instruments 1497.2001.016009606.x

to measure fatigue with myocardial infarction. Lee, K. S., Lennie, T. A., Heo, S., & Moser, D. K.

Western Journal of Nursing Research, 32, 967-983. (2012). Association of physical versus affective doi:10.1177/0193945910371320 depressive symptoms with cardiac event-free

Fink, A. M., Gonzalez, R. C., Lisowski, T., Pini, M., survival in patients with heart failure. Psycho- Fantuzzi, G., Levy, W. C., & Piano, M. R. (2012). somatic Medicine, 74, 452-458. doi:10.1097/

Fatigue, inflammation, and projected mortal- psy.0b013e31824a0641 ity in heart failure. Journal of Cardiac Failure, Leech, N. L., & Onwuegbuzie, A. J. (2009). A typol- 18, 711-716. http://dx.doi.org/10.1016/j.card- ogy of mixed methods research designs. Quality & fail.2012.07.003 Quantity, 43, 265-275. doi:10.1007/s11135-007-

Fink, A. M., Sullivan, S. L., Zerwic, J. J., & Piano, 9105-3

M. R. (2009). Fatigue with systolic heart failure. Lenz, E. R., Pugh, L. C., Milligan, R. A., Gift, A., &

Journal of Cardiovascular Nursing, 24, 410-417. Suppe, F. (1997). The middle-range theory of un- doi:10.1097/JCN.0b013e318 1laele84 pleasant symptoms: An update. Advances in Nursing

Goblirsch, G., Bershow, S., Cummings, K., Hayes, Science, 19, 14-27.

R., Kokoszka, M., Lu, Y., Sanders, D., & Zarling, Lindeberg, S. I., Rosvall, M., & ostergren, P.-O.

K. (2013). Stable coronary artery disease. Institute (2012). Exhaustion predicts coronary heart disease

for Clinical Systems Improvement. Retrieved from independently of symptoms of depression and https://www.icsi.org/_asset/t6bh6a/SCAD. pdf anxiety in men but not in women. Journal of

Greene, J. C. (2007). Mixed methods in social inquiry. Psychosomatic Research, 72, 17-21. doi:10.1016/j. San Francisco, CA: Jossey-Bass. jpsychores.2011.09.001

a APPENDIXF ® Fatigue in the Presence of Coronary Heart Disease

McHorney, C. A., Ware, J. E., & Raczek, A. E. (1993).

The MOS 36-item short-form health survey (SF-36):

Il. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Medical Care, 31, 247-263.

McSweeney, J. C., & Crane, P. B. (2000). Chal- lenging the rules: Womens prodromal and acute symptoms of myocardial infarction. Research in Nursing & Health, 23, 135-146. doi:10.1002/ (SICI)1098-240X-(200004)23:2<135::AID- NUR6>3.0.CO;2-1

Onwuegbuzie, A. J., & Combs, J. P. (2010). Emergent

data analysis techniques in mixed methods research: A synthesis. In Tashakkori, A. Teddlie, C. (Eds.),

Handbook of mixed methods in social and behav- ioral research (2nd ed., pp. 397-430). Los Angeles, CA: Sage.

Pragodpol, P., & Ryan, C. (2013). Critical review of

factors predicting health-related quality of life in newly diagnosed coronary artery disease patients. Journal of Cardiovascular Nursing, 28, 277-284. doi:10.1097/JCN.0b013e31824af56e

Ream, E., & Richardson, A. (1996). Fatigue: A concept

analysis. International Journal of Nursing Studies, 33, 519-529. doi:10.1016/0020-7489(96)00004-1

Reprinted with permission.

299

Shaffer, J. A., Davidson, K. W., Schwartz, J. E.,

Shimbo, D., Newman, J. D., Gurland, B. J., &

Maurer, M. S. (2012). Prevalence and character-

istics of anergia (lack of energy) in patients with acute coronary syndrome. American Journal of

Cardiology, 110, 1213-1218. doi:10.1016/;.amj- card.2012.06.022

Skapinakis, P., Lewis, G., Mavreas, V. (2004). Temporal

relations between unexplained fatigue and depression: Longitudinal data from an international study in primary care. Psychosomatic Medicine, 66, 330-335. doi:10.1097/01.psy.0000124757.10167.b1

Staniute, M., Bunevicius, A., Brozaitiene, J., &

Bunevicius, R. (2013). Relationship of health-

related quality of life with fatigue and exercise capacity in patients with coronary artery disease.

European Journal of Cardiovascular Nursing. doi:10.1177/1474515113496942

Zimmermann-Viehoff, F., Wang, H. X., Kirkeeide,

R., Schneiderman, N., Erdur, L., Deter, H. C., &

Orth-Gomer, K. (2013). Womens exhaustion and

coronary artery atherosclerosis progression: The Stockholm female coronary angiography study. Psychosomatic Medicine, 75, 478-485. doi:10.1097/ PSY.0b013e3182928c28

‘ Generating and Assessing Evidence for Nursing Practice (11th ed.)

CARE TRANSITION EXPERIENCE OF

SPOUSAL CAREGIVERS From a Geriatric Rehabilitation Unit to Home

Kerry Byrne e

> Abstract: The purpose of this study was to develop

a theoretical framework about caregivers’ expe-

riences and the processes in which they engaged

during their spouses’ transition from a geriatric re-

habilitation unit to home. We used a constructivist

grounded theory methodology approach. Forty-five

interviews were conducted across three points

in time with 18 older adult spousal caregivers.

A theoretical framework was developed within

which reconciling in response to fluctuating needs

emerged as the basic social process. Reconciling

included three subprocesses (i.e., navigating,

safekeeping, and repositioning), and highlighted

how caregivers responded to the fluctuating needs

of their spouse, to their own needs, and to those

of the marital dyad. Reconciling was situated

within a context shaped by a trajectory of prior care

transitions and intertwined life events experienced

by caregivers. Findings serve as a resource for

scientists, rehabilitation clinicians, educators, and

decision makers toward improving transitional care

for spousal caregivers.

> Key Words: aging, caregivers/caregiving -

grounded theory - health care - rehabilitation -

relationships - relationships, primary partner -

theory development

Joseph B. Orange e Catherine Ward-Griffin

Recent initiatives in care for older

persons with disabilities include geriatric rehabilitation units (GRUs). Care transi-

tions into and out of GRUs involve both the older person/patient and his or her family members (Fredman & Daly, 1998). Several

researchers have called for the inclusion of family caregivers and their goals (e.g.,

knowledge of and access to services) in

GRU assessment and rehabilitation pro- grams (Aminzadeh et al., 2005; Bradley et

al., 2000; Demers, Ska, Desrosiers, Alix, &

Wolfson, 2004; Hills, 1998). When family

caregivers agree with recommendations

made for their relatives during geriatric

assessments, adherence to the recommen-

dations is more likely to occur (Bogardus et al., 2004). Despite a primary focus on the older adults in the GRU, their family care-

givers often require their own health-related support in addition to information about

how best to care for their relatives (Demers

et al.; Hills); however, little is known about

how family caregivers experience their rela-

tive’s transition from the GRU to home, and

about the processes engaged in during care transitions.

Authors’ Note: Portions of this article were presented at the Canadian Association on Gerontology conference,

October, 2008, London, Canada, and the British Society of Gerontology conference, September 2009, Bristol, United

Kingdom.

300 Reprinted with permission from Byrne, K., Orange, J. B., and Ward-Griffin, C. (2011). Care transition experiences of spousal caregivers: From a geriatric rehabilitation unit to home. Qualitative Health Research, 21(10), 1371-1387.

APPENDIXG #&

Current models and theories of family caregiving (Lazarus & Folkman, 1984; Pearlin, Mullan, Semple, & Skaff, 1990;

Schumacher, 1995; Skaff, Pearlin, & Mullan,

1996) and transitions (Chick & Meleis,

1986; Meleis, Sawyer, Im, Hilfinger Messias,

& Schumacher, 2000; Schumacher, Jones,

& Meleis, 1999) include, in part, concepts

and processes related to caregiving during

transitions from hospital to home settings.

However, none focus on the processes enacted by caregivers during the experiences of their

relative’s transition from a GRU to home. As

a result, rehabilitation researchers, clinicians,

and policy makers have few conceptual

resources to help them understand how caregivers experience the transition of their

husband or wife from a GRU hospital based setting to home or, moreover, what caregivers

actually “do” during these transitions. The purpose of our study was to develop a the-

oretical framework illustrating how spousal

caregivers experience the transition of their

husband or wife from a GRU hospital-based setting to the home.

= Literature Review

SPOUSAL CAREGIVING

Spouses, more than any other caregiver, are likely to provide care during periods

of disability and illness, and are likely to continue doing so even as their own health

declines (Chappell, 1992; Hess & Soldo,

1985). A study commissioned by Health Canada (2002) found that family caregivers

are most likely to provide care to a spouse or partner (38%). Spousal caregivers experi-

ence adverse emotional and physical health, caregiving burden, and challenges with the role of caregiving (Braun, Mikulincer, Rydall,

Walsh, & Rodin, 2007; Connell, Janevic, &

Gallant, 2001; Jacobi et al., 2003). Fredman

and Daly (1998) reported that 46% of care-

givers are the spouses of individuals who are

discharged from GRUs. Given the extent to

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 301

which spouses engage in caregiving and the difficulties they encounter during transitional care, the present study focused specifically on spousal caregivers.

TRANSITIONAL CARE

Transitional care is defined as “a set of

actions designed to ensure the coordination and continuity of health care as patients

transfer between different locations or differ- ent levels of care within the same location”

(Coleman, Boult, & American Geriatrics

Society Health Care Systems Committee, 2003, p. 556). The study of transitional care

is crucial to optimize quality care for older

adults with complex care needs (Coleman et al.). Coleman and Williams (2007) proposed several key elements of a research agenda

designed to improve the quality of transitions

out of hospitals for older adults. They called for greater recognition of the integral role of family caregivers during care transitions.

Older adults and their family caregivers encounter numerous difficulties during care transitions (from acute care to home and into

long-term care), such as not feeling prepared for the transition, a lack of communication

with health care providers, difficulty obtain-

ing needed information (e.g., medical aspects of care), and access to resources (Bull, 1992;

Bull, Maryuyama, & Luo, 1995; Davies &

Nolan, 2003, 2004; Grimmer & Moss, 2001).

These difficulties contribute to family caregiv- ers’ negative experiences of care transitions.

Current definitions of and approaches

to transitional care (Coleman et al., 2003;

Holland & Harris, 2007) focus on patients’ experiences of moving between and among a range of health care settings. Unfortunately,

caregivers’ experiences often are not high-

lighted in definitions and current approaches.

In several recent interventions aimed at

improving care transitions, caregivers’ expe-

riences, their characteristics, and outcomes

during transition were not reported and/or

distinguished from patients’ perspectives and

experiences (Naylor, 2002; Naylor et al.,

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

302 APPENDIXG #

2007, Parry, Kramer, & Coleman, 2006).

Although patients’ perspectives of care

transitions obviously are critically important, grouping patient and caregiver perspectives

makes it very difficult to discern concerns

specific to each group. The blending clouds

our understandings of caregivers’ experiences of their relatives’ transitions to and from health care settings. A recent exception is the

study by Shyu, Chen, Chen, Wang, and Shao (2008), in which the investigators examined

the outcomes of a caregiver-oriented care

transition intervention for family caregivers of individuals who had suffered a stroke. They found that their intervention resulted

in higher self-evaluations of preparation and

better satisfaction of discharge needs in com- parison to a control group who received only

routine care.

CAREGIVING DURING CARE TRANSITIONS FROM HOSPITAL-BASED SETTINGS TO HOME

Several investigators have demonstrated that

caregiver needs, concerns, relationships, and

burdens are salient and change throughout the transition from hospital to home for

caregivers of older adult care recipients (e.g., Bull, 1990; Grimmer, Falco, & Moss, 2004;

Kane, Reinardy, Penrod, & Huck, 1999;

Naylor, Stephens, Bowles, & Bixby, 2005;

Shyu, 2000a). Many of these authors identified

“issues” that occur during transitions from

hospital to home, but few identified how care-

givers respond to the difficulties, changes, and

unmet needs that arise during the transition.

Notable exceptions include five studies that explored processes engaged in during care tran-

sitions from hospital to home (Bull, 1992; Bull

& Jervis, 1997; Li & Shyu, 2007; Shyu, 2000a, 2000b, 2000c), and whose authors put forth

theoretical frameworks (Bull, 1990; Li & Shyu;

Shyu, 2000b) to understand what caregivers are “doing” during periods of transitional care.

The published articles reporting on these studies offer useful findings; however, they provide limited information about how

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Care Transition Experience of Spousal Caregivers

spousal caregivers experience their husband’s or wife’s transition. First, none of the authors

considered the transition from a GRU unit to home. GRUs are an increasingly common

type of health care setting for older adults, and differ from acute care settings, where the majority of care transition work has been completed. Second, the majority of studies

group experiences of spousal caregivers with other types of caregivers (e.g., adult children,

daughters-in-law, siblings), even though research findings suggest that spouses experi- ence caregiving differently (Barnes, Given, & Given, 1992; Frederick & Fast, 1999; George

& Gwyther, 1986; Hayes, Zimmerman,

& Boylstein, 2010; Navon & Weinblatt,

1996). The grouping reduces our ability to

understand fully the issues specific to spousal caregivers’ experiences of care transitions.

Third, the experiences of spousal caregivers

aged 65 years and older are underrepresented.

For instance, the average age of caregivers in

studies that identified “how” they manage

transitions are always below 60 years (Bull,

1992; Bull & Jervis, 1997; Li & Shyu, 2007;

Shyu, 2000b, 2000c). Finally, the experiences

of caregivers prior to the discharge of their relative from a hospital-based setting were

addressed only by Shyu (2000b, 2000c).

Despite the important collective efforts of these investigators, we are left with little

knowledge about how spousal caregivers pre-

pare for the transition home from a GRU.

Recent attempts to describe transitions

to care for family caregivers of older adults have yielded no theoretical or conceptual framework that specifically addresses older adult spousal caregivers’ experiences of their relative’s transition from a GRU to home.

Such a framework would help guide educa- tion, research, and practice in rehabilitation

settings. The aim of our study was to develop a theoretical understanding of the processes engaged in by spousal caregivers during the

transfer of their husband/wife from a GRU to home. We gathered the perspectives of spousal caregivers who cared for older adult husbands or wives with and without cognitive impairment or dementia.

Reprinted

with permission.

a APPENDIX G @

@ Methodology

A constructivist grounded theory methodology

was used because it emphasizes the examination of processes and the creation of interpretive understandings (Charmaz, 2006). Ontologically, a constructivist approach highlights how the processes enacted during transition for caregiv-

ers are viewed as both individually experienced and socially constructed via interactions with other people. Grounded theory is an ideal meth-

odology to understand actions and processes

through transitions (Morse, 2009), and has been

used by qualitative researchers to study pro- cesses engaged in by patients (Grant, St John,

& Patterson, 2009) and family caregivers (Bull

& McShane, 2008; Holtslander & Duggleby,

2009).

SAMPLING AND RECRUITMENT

A 36-bed inpatient GRU housed within a

larger long-term care hospital in Ontario, Canada served as the recruitment site. The

first author (Byrne) contacted spousal caregiv- ers only after they indicated to a GRU team

member who was not affiliated with the study

that they were willing to participate. Spousal

caregivers participated in three interviews

(i.e., 48 hours prior to discharge, 2 weeks

postdischarge, and 1 month postdischarge).

In keeping with grounded theory method-

ology, both initial and theoretical sampling

techniques were used to guide data collection (Charmaz, 2006; Cutcliffe, 2000). Initial

sampling criteria included spousal caregivers

returning home with their husband or wife,

and spouses (both men and women) caring for their partner who did or did not have cognitive impairment or dementia.

PARTICIPANTS

Eighteen caregivers participated in the study (9

men, 9 women). Caregivers’ mean age was 77.4

years (range 65 to 89). They were married, on

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 303

average, 47 years (range 8 to 60). Four caregiv- ers were in a second marriage (M = 19.5 years,

range 8 to 36), and 14 were in their first mar- riage (M = 54.9 years, range 44 to 60). Eleven

caregivers reported receiving home care services,

and S did not receive any home care services.

Two caregivers were not available for followup postdischarge (see below). Care recipients’ mean age was 78.7 years (range 65 to 90). Five care

recipients had a diagnosis of dementia, 4 had other cognitive impairments (e.g., delirium, mild cognitive impairment), and 9 had no identified cognitive issues. The mean length of stay on

the GRU for care recipients was 41 days (range 22 to 77). Reasons for admission to the GRU

included deconditioning (some from acute care),

hip fracture, hip replacement, stroke, and knee

joint replacement.

DATA COLLECTION

The first author conducted 45 face-to-face inter-

views with 18 spousal caregivers on the GRU and in their homes. Interviews lasted between

35 and 120 minutes. Fifteen of 18 caregivers

were interviewed more than once (i.e., across

time); of these 15, total interview time per par-

ticipant ranged from 1.5 to 5 hours. Sensitizing concepts, based on previous

research on caregiving and transitions (e.g.,

Grimmer et al., 2004; Kneeshaw, Considine, &

Jennings, 1999; Showalter, Burger, & Salyer,

2000) such as changes in relationship and social

supports, were used as points of departure for

the interview guide and also guided the initial analysis. As recommended by Charmaz (2006),

these concepts were incorporated into specific questions in the initial interview guide and were

used as tentative tools to develop ideas about the processes in our data. For instance, partici-

pants were asked how they would describe their

relationship with their spouse currently (at the time of interview) in comparison to before they

were admitted to the GRU, and about who had

been especially helpful to them in caring for

their spouse. We were particularly attuned and

sensitive to these concepts during initial coding

and debriefing, as well.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

304 APPENDIXG &

Three time points for data collection were

planned: 48 hours prior to discharge from the GRU, 2 weeks postdischarge, and 4 to 6 weeks

postdischarge. These time periods were based on previous research on care transitions (Bull,

1992; Bull & Jervis, 1997; Lin, Hung, Liao,

Sheen, & jong, 2006; Naylor, 2000). Minor

changes to the initial intended time points were

made for several participants because of loss to follow up and scheduling conflicts. Twelve caregivers were interviewed at all three time

points. Three caregivers were interviewed at two points in time (7 = 1 at 2 weeks and 1 month postdischarge; 7 = 2 prior to discharge and 2 weeks postdischarge); of these, 1 caregiver was

not available prior to discharge, 1 did not want

to be followed up for a third interview, and

1 could not be reached for a third interview.

Three caregivers were interviewed only once (1 = 2 prior to discharge; 1 = 1 at 2 weeks post

discharge); of these, 2 were not discharged

as planned and so could not be followed up,

and 1 was not available at the other points

in time (i.e., prior to discharge or 1 month

postdischarge). First interviews were conducted

between 72 and 48 hours prior to discharge (1 = 12) and 1 to 6 days postdischarge (n = 6).

Second interviews occurred between 14 and 21

days postdischarge (one of the second interviews

was conducted 29 days postdischarge because

of scheduling conflicts). Third interviews were

conducted between 28 and 64 days postdis-

charge. Data collection began September 2006 and continued until November 2007.

In accordance with theoretical sampling, the categories noted to be relevant to the develop-

ment of the emerging theoretical framework

guided the sampling process rather than partic-

ular sample characteristics such as demograph-

ics. For example, as we tried to understand

how and when caregivers “shifted the bound-

aries” (an element in the theoretical frame-

work), it emerged that this experience might be different for men caregivers. Therefore, the

last few caregivers who were interviewed were deliberately men so that elements of how and when they shifted the boundaries and how this differed from the experiences that emerged for women caregivers could be explored.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Care Transition Experience of Spousal Caregivers

Interviews were digitally audio-recorded by the first author, transcribed verbatim by an experienced transcriptionist, and verified by the first author. In keeping with grounded theory methodology, data generation and data analysis occurred simultaneously, which

supported follow-ups with participants about

emergent codes and categories.

OBSERVATIONS

Observations of interactions between spouses

and care recipients were made prior to, during,

and after interviews, and were recorded in a

field notebook (guided by Charmaz, 2006;

Morse & Field, 1995). Specific observation times were not established a priori. The inter- viewer (first author) was “finely tuned in” to

look for interactions that would help elucidate processes and categories emerging from the data (Charmaz). Throughout the duration of the study, an electronic field notebook was

used to record observations, reflexive journal

entries, audit trail details, and field notes about

each interview.

Care recipient spouses were included in

observations but were not interviewed. We

wanted spousal caregivers to be able to speak candidly about their relationships, and thus provided the option for them to be inter- viewed either without partners present or

outside of their homes. If care recipients were present, we did not want to miss the opportu-

nity to observe interactions; thus, we included

an observational component and included the care recipient in this method of data collec- tion. This approach proved to be fruitful, as

the interviewer was able to “see” the actions

engaged in by caregivers during the interviews in which partners were present.

ANALYSIS

The first author engaged in line-by-line coding. As data collection and analysis pro- gressed, all authors contributed to focused coding, followed by theoretical coding

Reprinted

with permission.

~ APPENDIXG

(Charmaz, 2006) using the constant com-

parative method with all units of data. For example, in the early stages of data collection and analysis, we noticed that caregivers con- tinually used the phrase “I don’t know,” and thus an open code by this name was created

to capture this aspect of the data. As data

collection and analysis proceeded, we engaged

in focused coding using the term knowing/ not knowing to reflect these instances in the data. The following comment by Marie,1 was coded as knowing/not knowing, but through theoretical coding was understood to be part of the process of navigating:

I don’t know how long it [medication for

dementia] will last, I can’t find out. ’ve asked

different doctors and nurses and they don’t

know, don’t say how long it’ll, but I hope it’s years. You know, asked those questions. Why

and how long do they think, maybe they can’t tell, I don’t know, how long do they think that

they can give it to him?

To develop this category further, caregivers were asked how they became informed and

what helped or did not help them to do so. We began to understand how navigating was

critical to safekeeping (theoretical coding). Constant comparison entailed comparing

incident to incident and comparing incidents

over time between and within participants.

Charmaz (2006) encouraged looking for

implicit actions and meanings, comparing statements at one point, and comparing inci-

dents at different points in time. Tables were created to compare instances across time. Once the theoretical code of navigating was identified, quotations from participants that

reflected the various elements of this process (such as negotiating paths) were put into a

table so we could examine the change in pro-

cesses across time. Moving from line-by-line coding to

focused coding was not a linear process. As we engaged with the data, we returned to the data collected to explore new ideas and

conceptualizations of codes. The simultane- ous actions of collecting and analyzing data supported the discovery of gaps in the data,

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 305

which were then filled by going back to exist- ing participants and conducting interviews with new participants.

When a code was raised to the level of

a category, the first author created a memo describing the category, the elements con-

tained in the category, illustrative quotes

that reflected the category, and further ideas

on which to follow up to ensure theoretical

saturation of the category. These memos were shared and discussed among authors. This process continued until we had no new

elements to add to a category. To foster theo-

retical sensitivity, memos focused on actions

and processes, and gradually incorporated

relevant literature (e.g., theoretical perspec- tives on transition; Charmaz, 2006). We used

diagramming (Lofland, Snow, Anderson, & Lofland, 2006) throughout data generation

and analysis to help us understand the rela-

tionships between and within the emerging processes.

CRITERIA FOR RIGOR

The criteria and techniques we used to evalu-

ate the rigor of this study were a combination of those deemed to be important for (a) qual-

itative research in general, (b) constructivist

approaches, and (c) grounded theory meth-

odology. Techniques to establish reflexivity, transparency, authenticity, and credibility

(Ballinger, 2004; Beck,1993; Charmaz, 2006;

Chiovitti & Piran, 2003; Guba & Lincoln,

1989) included peer debriefing, reflexive journal entries, postinterview notes, an audit

trail, theoretical sampling, memoing, con- stant comparison methods, triangulation, and

member checking. The paradigm of our research was con-

structivist, and assumed multiple realities; consequently, the repeatability of the research

itself was not relevant (Sandelowksi, 1993).

However, techniques traditionally associ- ated with repeatability and confirmability,

such as triangulation and member checks,

were used and conceptualized according to a

constructivist perspective. Our use of member

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

306 APPENDIXG #

checking facilitated a fuller understanding of the experiences of participants. The prelimi- nary theoretical framework was shared with

five caregivers (who had participated in earlier

interviews) to explore whether or not their

experiences of transition were reflected in the

emergent framework. Caregivers reported being able to “see” their own experience

of transition in the processes presented. In addition, the framework was further refined

to reflect the feedback from these participants.

For example, the phase of getting ready was focused on largely relative to the physical and environmental preparations that must be made throughout transition; however,

during reflections about the findings pre- sented, caregivers discussed the need to be

mentally and emotionally prepared during the

phase of getting ready. On returning to the

data generated for the study and considering

participant experiences, emotional aspects of

this phase and the framework in general were explored more fully and included in the final theoretical framework. Similarly, we used triangulation not to confirm existing data, but rather to enhance completeness (Redfern &

Norman, 1994). This was achieved through

our use of in-depth interviews, observations,

and detailed field notes.

GETTING

READY

GETTING

INTO IT

Care Transition Experience of Spousal Caregivers

The University of Western Ontario Ethics

Board for Health Sciences Research Involving Human Subjects (HSREB) and the hospi-

tal ethics board at the GRU approved the procedures for interviewing and consent.

Participants received a detailed letter of infor- mation (LOI) and were informed that they had the right to withdraw from the study at any time. Direct and clear wording in the LOI indicated that participant information would be treated confidentially and used only for the purposes of the study. Participants were informed that there would be no identifiable individual data in published findings, and participants’ names and other identifying demographic information would be altered to ensure participants’ anonymity.

@ Findings

OVERALL FRAMEWORK: RECONCILING

The findings from this study describe the basic social process of reconciling (see Figure 1)

enacted by caregivers to integrate and merge

the dissonance between their past and present

knowledge, skills, roles, relationships

GETTING

ON WITH IT

Fluctuating Needs :

Navigating Safekeeping

TRAJECTORY OF CARE TRANSITIONS

INTERTWINED LIFE EVENTS

Figure 1. Theoretical framework of reconciling

Reprinted with permission.

= APPENDIXG @

(e.g., marital relationships), beliefs, routines,

and life circumstances. Reconciling occurred

e Within a context shaped by a trajectory of

prior care transitions and intertwined life events

¢ Across three overlapping phases: getting

ready, getting into it, and getting on with it

e Through three subprocesses: navigating, safekeeping, and repositioning

Reconciling captures spousal caregivers’

interactions with their husband’s or wife’s

health care providers, families, and friends,

and advances a theoretical understanding of the strategies caregivers used during their

relative’s transition from the GRU to home. The following excerpt from Eileen, who cared for her husband with dementia, illustrates the

basic social process of reconciling:

But you adjust somehow. It’s amazing what you

can adjust to, it’s amazing how you can say,

“Well, this is the way it is.” I’m not a person

that goes around feeling bitter or down or

depressed or anything like that, you just deal

with what you got dealt, as they say. So it’s

just getting, my getting used to somebody who

moves differently. I mean it takes him a long

time to get up out of his chair, and to get to

the bathroom or to the bedroom. And I have to

allow for that. I can’t operate mentally in the same way that I used to because it ain’t going to

happen. It’s different now.

Why did caregivers engage in reconciling?

They did so in response to fluctuating needs, including the physical, medical, emotional, and social needs of the caregivers them-

selves, their spouse, and the marital dyad.

Caregivers’ needs included information, skills, and directives about medications and

medical aspects of care (e.g., how to use a condom catheter); exercise regimes; cogni-

tive impairment; dementia; transportation

options; services in the community (e.g., how

to “get out” in public with their spouse and the walker; caregiver respite; how to connect with other caregivers); food preparation (e.g.,

how to prepare low-sodium food); how to

work through their own emotions of anx- iety, guilt, and feeling unappreciated; and

Reprinted with permission.

Care Transition Experience of Spousal Caregivers 307

finally, their own social needs and those of their partner. Needs fluctuated for a variety of reasons. Prior to leaving the GRU, during the phase of getting into it, several caregivers

did not discuss a lot of needs; however, once

caregivers were home with their husband or wife and were getting into it, needs surfaced

and caregivers realized they were missing essential knowledge required to care for their spouse or themselves. In some cases, changing circumstances, such as declining function or

increased depression, necessitated the need for information about the decline or how to cope with the psychological changes caregivers were observing.

UNDERSTANDING THE CONTEXT THAT SHAPES THE PROCESS OF RECONCILING

As depicted in Figure 1, reconciling from the

GRU to home was embedded within (a) a

trajectory of prior care and resultant health

care setting transitions, and (b) the context

of ongoing intertwined life events that were often the result of the caregivers’ own aging- related experiences.

Reconciling Within the Context of a

Trajectory of Care Transitions. During the

first interview (generally 48 hours prior to the

discharge of their spouse) it became apparent that even though caregivers were in the midst of preparing to take their spouse home from

the GRU, they were still coping with issues that occurred in other health care settings. For

instance, Tony spent much time reflecting on

his experiences during the time his wife was in acute care. During this period he was told that his wife would likely not survive, but that if she did she would require long-term care. Although neither of these scenarios material- ized, during the first interview with Tony, he was still reconciling these experiences:

The rough time, the really, really rough time

was when she was at [acute care unit], when

she was really sick. That was the rough time. I

mean, many a time I’d come home crying, and I

would just lay in bed and just let it go.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

308 APPENDIXG #® Care Transition Experience of Spousal Caregivers

Similarly, to understand how Marie

experienced the GRU-to-home transition, it was critical to understand the context of the multiple care settings from which she and her

husband had emerged. A year before Marie’s first interview, her husband was admitted to

acute care and then discharged to a long-term

care facility under the following circum- stances, as explained by Marie:

Yeah because they wouldn’t do nothing [at acute care]. And then they, the bed come up at

[nursing home], which I didn’t want but you

can’t say no. They said you have no say, if a bed

comes and you refuse it you pay for the hospital

bed. And I couldn’t refuse it, I had nothing to say, he had to go. Wherever they said, what they

come up with. So I had to sign and let him go

there.

Marie worked steadily from that point forward to get her husband home, and part of that work was getting him into the GRU. She explained her struggle:

Well there’s a lot in the family that didn’t want

me to bring him, but I said, “No, he’s coming

home. He’s not staying. Why would he have to stay in there,” I said? It’s not for him. All the

while he’s okay, he’s got his mind now, why

would | put him in there to stay? | wanted him

home with me, I really missed him. So I would

never ask her [sister], or anyone else. I’d have

to figure it out myself, that’s the only way you

can do things. You can’t rely on anyone. I can’t.

I can’t depend on anyone. I have people tell me

I’m selfish. Do you think I’m selfish for wanting to bring him home?

Marie’s decision to work toward having

her husband at home influenced her experi- ence of reconciling during the transition from

the GRU to home, namely the lack of support she received from her family, who did not

think she should be caring for her husband at home. Consequently, her experience of recon- ciling from the GRU to home was shaped by a lack of support, a feeling of isolation, and her decision not to rely on anyone. Understanding

the process of reconciling for caregivers is a

matter of placing the GRU-to-home transition

within the context of where they have come

“from.”

Reconciling Within the Context of

Intertwined Life Events. It was not only

the multiple care transitions that were most salient in shaping the process of reconciling;

rather, caregivers were reconciling within a

context of ongoing, intertwined life events (i.e., intertwined with GRU-to-home tran-

sitions). These interwoven life events often

involved larger life transitions such as relo- cating their home to new living circumstances (e.g., downsizing to an apartment or condo-

minium); coping with their own health issues,

illnesses, and transitions within their own

marriage; and other family and friend rela- tionships. Individual caregiving circumstances

meant that some caregivers were relocating to new living circumstances, coping with an

alcoholic partner or the death of a child, and handling adverse relationships with other

family members. These intertwined life events

served to facilitate or undermine reconciling. For several years prior to the interview Jessica

had been dealing with her husband, who was

an alcoholic. This “dealing with” influenced tremendously her experience of reconciling.

Jessica revealed what it was like to be home

with her husband after the admission to the GRU:

Well it’s probably a lot calmer. See, I haven’t told you [that] the initiating problem here

was acute alcoholism, and so life hasn’t been

very peaceful. And now he’s been off it for

four months, and he’s also been on antide-

pressants, so he’s not as he was, so he’s not as

difficult and cranky to deal with. He’s much

calmer. Certainly so that makes it easier,

yeah. So however, it’s nice to see him sober

for a change.

Relocating to smaller living arrange- ments was paramount for several caregivers. Some caregivers were in the process of relo-

cating while their spouses were on the GRU, whereas others had moved just prior to the GRU admission. In addition, caregivers

were reconciling within a context shaped by

a APPENDIXG

their own ongoing health and illness experi- ences. Declines in the their own health and function were a very real worry, because many knew that if something happened to them, their spouse would end up in long- term care.

Sean expressed his worry: “The only

concerns that I got right now, dear, is if I

stay healthy. That’s my biggest concern.” A detailed examination of contextual forces

shaping the process of reconciling enabled

us to increase our understanding of the

meanings of past forces on transitions. In the next sections we describe the three phases of reconciling.

THREE PHASES OF RECONCILING

Each of the three phases of reconciling (get- ting ready, getting into it, getting on with

it) was differentiated by (a) the saliency of

each subprocess (i.e., navigating, safekeep- ing, and repositioning) within a phase, and (b) the patterns among the subprocesses engaged in within each phase across time. The three phases, though not mutually

exclusive on a time scale, corresponded

approximately to spousal caregivers’

experiences prior to discharge home (.e., getting ready), the first 2 to 3 weeks home

postdischarge (i.e., getting into it), and several weeks postdischarge (i.e., getting on with it). The phases were not necessarily

linear, but rather overlapped one another. Movement from one phase to another was subtle, particularly the shift between getting

into it and getting on with it. The first phase of reconciling, getting

ready, was characterized by spousal caregiv- ers’ multifaceted preparations, including phys- ical, emotional, and environmental, which

were aimed at optimizing the care provided for their spouses. Tony explained:

There’s getting ready emotionally, getting ready

physically, and then getting the house ready.

‘Cause a lot of people coming out of [the GRU],

you have to make a lot of changes to the house.

So to me, getting ready can be multifaceted.

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 309

For the most part, caregivers were pleased to be taking their spouse home. However, they also were aware of how difficult it would be and aware of the need to prepare themselves emotionally. Jack revealed how, in some ways, it was easier for him to have his wife on the GRU: “I didn’t have to worry about caring for

her [at home]. . . so actually going to the hos- pital was easier for me, because | didn’t have to look after her.” In the getting-ready phase, spousal caregivers were juggling numerous pieces of information and were meeting with a

range of health care providers. This occurred while they prepared themselves emotionally for their spouse to return home and made needed physical changes to their home to ensure safety (e.g., installed wheelchair ramps, grab bars, and so forth).

The second phase of reconciling, getting into it, began when husbands or wives were discharged home and spousal caregivers

assumed the majority of care. The prepara- tions and knowledge gleaned (or not) influ-

enced caregivers on a day-to-day basis. The getting-into-it phase was the busiest of the

three phases for caregivers, during which time they coped with multiple demands surround-

ing care for their spouse. Movement from the second phase of getting

into it to the third phase of getting on with it was relatively insidious. The third phase of

reconciling, getting on with it, represented a subtle shift from a focus that included GRU

related issues, such as illness and impair-

ments, to a focus on striving for predictability, enabling the social health of their spouse and shifting the care boundaries that caregivers set

previously for themselves. The phase of getting on with it was demarcated by the focus of care- givers on not just the medical aspects of care,

but rather on a distinct attention to facilitate

and enable opportunities for social participa- tion both within and outside of the home for

themselves, their spouse, and them as a couple.

The three phases, and the second and third in

particular, are best explained and understood through an exploration of the various sub-

processes enacted by spouses during this care

transition.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

310 APPENDIXG #® Care Transition Experience of Spousal Caregivers

SUBPROCESSES ENACTED ACROSS PHASES OF RECONCILING

Caregivers were reconciling through the

three phases by enacting three interdepen-

dent subprocesses including navigating, safekeeping, and repositioning. These three

subprocesses encompassed a range of strat- egies that changed over time, in response to the fluctuating needs of caregivers, the needs of their spouse, and their marriage. A brief

overview of each subprocess and associ-

ated strategies is provided in the following section; however, a more detailed discussion

of these subprocesses can be found in Byrne

(2008), and will be the topic of forthcoming articles.

Navigating. Navigating emerged as a sub-

process whereby caregivers were locating,

evaluating, creating, and integrating past

and current sources of knowledge. Through navigating, caregivers were reconciling

previous knowledge with new knowledge

needed to care for their spouse, themselves

individually, and as a couple. Navigating

was accomplished through three strategies, including negotiating paths to knowledge

formulation, maneuvering obstacles, and

making decisions. Caregivers negotiated

paths that were merging, connecting, and

diverging toward the formulation of the knowledge base they needed. A merging path

resulted when caregivers used knowledge and

skills gleaned from previous experiences with health care providers and/or providing care

for their spouse. Connecting paths resulted

when caregivers received much needed new

knowledge to meet the needs of their spouse, themselves, and the marital dyad. Kathleen explained:

Yeah, that you got all, because usually when

you leave the hospital they give you your list of

prescriptions to get filled and everything. But I think if your husband isn’t walking great, well,

you have to have a walker and things; for the

bathroom to sit on, he’s got a higher seat to sit

on, and he’s got a seat in the bathtub for when

he’s getting a bath. He doesn’t have to stand all

the time, and he has safety bars all around the

shower to hold on to. But they did ask me at the GRU what I had and what I didn’t have, to

make sure I had everything.

Divergent paths, conversely, resulted when caregivers did not receive needed knowledge. Paths were divergent when knowledge for caregivers was absent, incorrect, difficult to

understand, conflicting, or when it is was

provided at the wrong time:

But just somebody to say, “How are you doing?

How are things going? Is there anything you

need that you’re not getting?” and just like I

could use somebody, I mean, somebody to come

in and help with the housework, to clean, and

but, just some support for caregivers, that’s

what you need, and I don’t think it’s available,

to get it in terms of your, of your needs for your

client. But there’s no support for the caregiver.

Does that make sense? Yeah, like this is what

I did when I had this, or has anybody got any

suggestions for that, or just a time to have a cup

of coffee with somebody that’s going through

the same thing.

In response to these diverging paths, care- givers maneuvered obstacles by taking actions

such as sorting multiple sources of knowledge, looking for directions, and learning through experiences. Jessica explained:

And here’s CCAC [community care access cen-

ter], and everybody was coming in to his room

at once. And um, so I came home and I had to

sit down immediately and make out huge charts of, especially his medication chart, and uh,

who was coming when, and try to sort out all

this information that I got, that last day, which

might have been perhaps a good idea to have

had that a couple days before he went home, so

I'd have time to work it out. But anyway I got it . straightened away.

Caregivers made decisions based on the information and services that were available,

and based on what was perceived as best for their husband or wife or themselves. Several caregivers turned down services they were

offered because the services did not meet their specific needs, or they felt that the services were not needed. Deborah commented on her decision to not accept help from Meals on

Le APPENDIXG #

Wheels (an organization that provides home- delivered meals):

And the social worker said what about Meals

on Wheels, and I said oh no, I’m not going

to sit and wait for somebody, if it’s snowing. Well last week there was no Meals on Wheels,

nobody got meals, it stopped. So I said, Meals

on Wheels, I says no, I said I’m quite capable.

So we eat when we want to, not because we

have to. No, no, no they did send somebody

down and were insisting on home, Meals on

Wheels, and somebody to do your laundry. And

I thought God’s sake, no—I’d be sitting here

waiting for somebody, I’d have it done.

Elements of navigating changed over

time across phases. For example, during

the phase of getting ready, caregivers most often faced an absence of sources of knowledge related to how their spouse would progress once discharged from the GRU, and which types of services would be

received in the home. However, during the

phase of getting into it, caregivers often did

not have information about medications,

dietary restrictions, and home care services,

among other service-related information. It

was only once their spouse was discharged home, and care was placed squarely on the shoulders of the caregivers, that the caregiv- ers then realized the extent of what they did not know.

Safekeeping. Safekeeping, the second sub- process of reconciling, highlights how care- givers protected, promoted, and enhanced the emotional, physical, and social health of their spouse. Caregivers engaged in safe- keeping when there was a risk or perceived threat to their spouse’s safety, or to the

maintenance of or improvement in physical, emotional, or social health and well-being. Three strategies were used by caregivers

during safekeeping, including advocating, shielding, and enabling physical and social health. Caregivers advocated on behalf of

their spouse by challenging health care pro- viders or other family members to ensure that their spouse received proper care and

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 311

requisite services. Sean discussed how he felt the home care services were not meeting his wife’s needs, and how he was handling the situation:

Yeah, they do, some of them are pretty good,

but there’s more of them that are just, I don’t

know. They, they come in and they just, some-

times I wonder if they, see they’re supposed to

brush her teeth, they’re supposed to comb her

hair, they’re supposed to give her a, a sponge

bath if she doesn’t get in the tub, and they’re supposed to give her a bath twice a week, and

I got after them last week. She had two baths

last week, but I got after them because I wanted her, her bathed twice a week at least, a sponge

bath. A sponge bath is not the same as a shower

or baths, is it, eh? They’re not doing, there’s a

couple of them there is not doing their job, I’ll

tell you that right now, and one of these days

I’m going to get mad. I don’t get mad, but when

down

In addition, caregivers, particularly for

individuals with cognitive impairment or

dementia, shielded the emotional health of

their spouse. During interviews, caregivers

did not want to discuss aspects of dementia while their spouse was present, stating that

they did not talk about the “memory prob- lems” or use the word dementia in front of him or her. For instance, while interviewing

Marie, she stated,

Yeah, well I’m hoping the Aricept [medication]

will keep on working. And they’re always

coming out with new drugs [lowers her voice

and looks at husband who is sitting across the

room]. I don’t talk to him too much about it,

COpete

Observations revealed that caregivers shielded their partners from the interview

process itself. This manifested, for example, as whispering or speaking in lowered, hushed tones during the interview. Enabling emerged

as a strategy by which caregivers promoted,

demanded, facilitated, or encouraged courses

of action to benefit the physical and/or social

health of their spouse and themselves. Jack

explained:

Generating and Assessing Evidence for Nursing Practice (11th ed.)

312 APPENDIXG ® Care Transition Experience of Spousal Caregivers

And it’s quite easy to say, well, the caregiver

to say, well the heck with the exercises, why

bother? Or well, I’m going out, I’ll bring some- one in to look after you, and don’t push, or let’s

go ourselves. You got to do a lot of pushing

to get the person going. That’s another thing I

think a lot of people find difficult.

Enabling was intended to keep partners

safe, to serve as a limit on caregivers’ own

worry and anxiety, and to meet the social

needs of both their spouse and themselves. Several instances of enabling were observed while the first author was present in caregivers’ homes. For instance, Patrick instructed his wife

to uncross her legs, whereas Nicholas demon- strated to his wife how and when she should

keep the brakes on her walker. Enabling health

was affected by the knowledge barriers faced by caregivers. Kevin explained how not know- ing influenced his ability to enable the physical

health of his wife:

I don’t know when to push her. She gets out

here and takes her walker and walks to the end

of the driveway and back, and then she says,

“Pm tired.” I don’t know whether to say, “Do

it again.” Who am I to say that when she says

she’s tired? Unless I knew what I was doing, and

I don’t, I can’t say that to her. I said, “Honey,

leave it up to the day hospital. Whatever they

tell you, that’s what you should be doing.”

Safekeeping manifested differently across phases depending on the strategy employed by caregivers. For instance, one of the major differences between the phases of getting into

it and getting on with it was that spousal caregivers shifted from a focus of enabling physical health to a focus on enabling social

health. Once caregivers mastered enabling

physical health they began enabling social

health for their spouse and themselves by engaging in social outings.

Repositioning. Repositioning, the third

subprocess, was used by caregivers to alter, shift, and modify either temporarily or

permanently their geographical space and

place, relationships, and social positions.

Positions for caregivers included locations,

Generating and Assessing Evidence for Nursing Practice (11th ed.)

roles, beliefs, and attitudes, and encom-

passed geographical, emotional, and social aspects. Caregivers engaged in repositioning

to reconcile the dissonance between past

and present beliefs, and roles regarding, for example, what their marriages “used to be like” in relation to what their relationship

was currently like. Repositioning strategies

included vowing to care, anticipating, shift- ing the boundaries, and striving for predict- ability. The strategy of vowing to care was

permeated with beliefs that providing care was part of the duty to the couple’s relation-

ship. Sean talked about caring for his wife

with dementia:

Well, I, I, geez, that’s, why do I do it? Why do I

do it? Well, the way I look at it is, ’ve been mar-

ried to her now for 52 years. I love the woman,

and that’s probably why I do it. I got, i don’t find no other reason to do it, that’s just, that’s the rea-

son, that’s the reason why I do it, because I don’t

want to see nothing happen to her, or anything

like that, as far as that, at least I hope not. And

if I could do anything for her I'd gladly do it, if I

could help her in any way, even if I can help her,

you know, get rid of this dementia or Alzheimer’s

[disease], but I can’t do that. The only one that

can do that is the one up above. I can’t do that. I

just got to do the best I can and live with it.

In some cases, caregivers discussed how

they repositioned their relationship from

that as husband and wife to that of parent

and child or brother and sister. Caregivers described power differentials that developed within their relationship, role reversals, absent sexual relationships, and the need to learn how to operate as a single person. Changes

to the spousal relationship, despite vowing . to care, were not always viewed positively,

but as an occurrence that had to happen out of necessity. It was difficult for caregivers to accept and cope with changing marital rela- tionships from emotional perspectives. Irene

explained: “I think because now he’s become sort of like the child and I’m the parent. And I don’t like that situation. Id like to be an equal partner.”

Anticipating emerged as a second strategy

whereby caregivers envisioned immediate

Reprinted

with permission.

a APPENDIXG

and long-term situations. Anticipating was

critical to the entire process of reconciling,

because it “paved the way” for merging and integrating past, present, and potential future

circumstances. Anticipating was related to

several other processes. As examples, caregiv- ers anticipated what types of safekeeping they would engage in once home. They anticipated

what kinds of activities they would enable once home. They anticipated the need for rou-

tines, and used anticipation as a strategy for maneuvering barriers (e.g., planning or wait-

ing to look for directions). Without the proper sources of knowledge, or without understand-

ing of information received, caregivers had a difficult time anticipating. For example, caregivers were unsure as to how their spouse would progress once home, and without infor-

mation about potential progress once home from GRU team members it was difficult to anticipate what the coming situations (i.e., at

home with their spouse) would entail.

Shifting the boundaries emerged as a third strategy of setting and shifting limits for

“self” based on beliefs, feelings, and comfort

levels. Caregivers adjusted their own activities

outside of the home for fear that something bad would happen while they were gone, and/or for fear that their spouse would feel neglected if left on his or her own. During the phase of getting on with it, men and women differed in their responses relative to the strat- egy of shifting the boundaries, particularly for their own activities and participation. Men

expressed the desire and the need for their own social life outside the marriage. Kevin

illustrated how, although he wanted to partic- ipate in activities with his wife, he still needed to have his own life within the marriage:

We are definitely going to go to join something. I

think it would be beneficial for my wife and could

be beneficial for me to meet some people. What I gather is that the men go off and play darts and

the women play euchre [game] or whatever they

do. I think it’s kind of necessary for caregivers and their spouses to get a little separate time from

each other. My wife has always been insecure. If

I go anywhere, she wants to come with me. If I am going to Canadian Tire she’ll say, can I come?

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 313

Sometimes I would like to go to be by myself.

Part of my wife’s being hospitalized, I would take

walks by myself around the grounds of the hospi-

tal. I miss a lot of the male comradeship now, just don’t have time for it really.

For women, however, guilt persisted about

leaving their husband alone, even as time

since discharge progressed. One month post- discharge, Phyllis explained:

Because it sort of hurts and it’s an effort he

doesn’t want to particularly do it, so. Like for

instance, he said, well my daughter asked us out

for New Year’s. [He said], “I couldn’t go out

again, I just, ’m not gonna go. You go.” But

uh, whether I’ll go or not, I don’t know, cause

Pl feel badly leaving him. So I might go fora

couple of hours or something.

Striving for predictability emerged as the fourth strategy, which included integrating predictable courses of action into day-to-day

life. Caregivers were striving for predict-

ability in response to the need for order and routine.

While spouses were on the GRU, most caregivers took daily trips to the hospital

as a means of maintaining normalcy and providing emotional comfort for their spouse

and for themselves. Once home, caregivers strove for predictability to integrate previous daily patterns, with the need to establish

new patterns such as incorporating exercise

regimes and new diets or, for some caregiv-

ers, making their spouse incorporate their

assistive devices (e.g., walkers) into their

life. Deborah commented, “But I have a

routine that keeps me going,” and Irene said,

“But it’s just to try and get some predict-

ability in my routine, to know what, what’s

happening.”

= Discussion

Consistent with the aims of constructivist theorizing (Charmaz, 2006), the framework

developed in this study provides a plausible

account of the processes experienced by spou-

sal caregivers during transition; highlights

Generating and Assessing Evidence for Nursing Practice (11th ed.)

314 APPENDIXG = Care Transition Experience of Spousal Caregivers

patterns and connections not previously con-

sidered; and provides new ways of thinking

about the processes engaged in by spousal caregivers’ to inform rehabilitation clinicians, researchers, and policy makers. This inves- tigation is the first to explore the processes

enacted by spousal caregivers during the

transition of their relative from a GRU to home. Prior research describing the processes

engaged in by family members during their

relatives’ hospital-tohome transition included

processes directed mainly at medical aspects (Bull, 1992; Bull & Jervis, 1997) and, ina

select few studies, the emotional and rela-

tional processes involved in providing care (Bull, 1992; Shyu, 2000b, 2000c). However,

none of the authors of the resulting articles

mentioned the social aspects of providing

care, such as enabling social health of the care

recipients, or setting and shifting boundaries for their own social participation, as was

identified in our findings. Reconciling was

not simply about integrating past and present medical care routines or engaging in the more

medical and physical aspects of caregiving,

but rather reflected a strong emotional and social component, as well. This has not been addressed adequately in prior research. The

needs, processes, and strategies engaged in

by spousal caregivers highlight the medical,

physical, emotional, and social elements of

reconciling, and the biopsychosocial nature

of care transitions as experienced by spousal caregivers.

Furthermore, in a theory of transition

developed by Meleis and colleagues (2000),

several patterns of transition, including single,

multiple, sequential, simultaneous, related,

or unrelated, are discussed. These patterns

characterize the potential multiplicity and

complexity of transitions as identified in their theory. Our framework supports the multidi-

mensional and complex nature of transitions

put forth by Meleis et al., and our findings show the influence of multiple sequential

(health care setting transitions) and simultane-

ous (relocating, declining health of caregiver,

changing spousal relationship) transitions on the experience of the transition from hospital

Generating and Assessing Evidence for Nursing Practice (11th ed.)

to home (i.e., process of reconciling). It is the

patterns among all of these different transi- tions that support a comprehensive under- standing of the hospital-to-home transition itself, and elucidate the complexity of the process of reconciling. For example, Phyllis’ experience of reconciling from hospital to home was influenced by her own declining health as she was feeling depressed about her health while simultaneously caring for her spouse and meeting his physical needs. Trying

to come to terms with the present situation

was complicated by her concerns about her own physical and emotional health.

Although the present study incorporated only a single care transition (i.e., from GRU

to home), it highlights how experiences

during prior health care setting trajectories

influenced caregivers’ engagement in the

process of reconciling. This was particularly

salient for caregivers who almost lost their spouse in acute care health settings, or who had particularly stressful experiences in acute

care. In a study exploring caregivers’ experi-

ences of transition to long-term care, Reuss,

Dupuis, and Whitfield (2005) reported that

many of the families in their study (includ- ing spousal caregivers) experienced multiple transfers between different settings prior to their relatives’ placement in a longterm care facility. They called for longitudinal research

to explore the experiences of multiple tran- sitions for families and their relatives. Our study supports this contention, and provides

insight into one of the many potential care transitions (hospital to home) that can pre-

cede caregivers’ experiences of the transfer of their relative to long-term care. ,

The process of reconciling identified in the present study was influenced not only by a range of caregiving contexts, but also by care- givers’ experiences of intertwined life events. For example, in our findings, the death of a family member, marital discord, and conflicts with other family members influenced care-

givers’ experiences of reconciling. Intertwined life events share similarities with the concept of “linked lives” in Elder’s life course theory, which addresses the interdependent nature

Reprinted

with permission.

- APPENDIXG #@

of social life and relationships (Elder, 1998;

Elder & Johnson, 2003). The emergence of the influence of intertwined life events during the transition from the GRU has important

implications for the need to explore the expe-

riences of older adults (65 and older) pro-

viding care during their older adult relatives’ transition from hospital to home. Older adult

caregivers are an underrepresented group of caregivers in other studies of hospital-to-home

transitions. Spousal caregivers were experienc-

ing transitions in other aspects of life that are common to aging individuals, such as relo- cation (Firbank & Johnson-Lafleur, 2007).

Intertwined life events influenced the transi-

tion. For example, if caregivers had relocated

recently, then they had greater difficulty rec- onciling, particularly with regard to striving for predictability. In addition, anticipating the need for relocation was perceived as stressful

for some caregivers, especially if it involved the placement of their spouse in long-term

care. Declining self-health was another key consideration regarding the process of recon- ciling for older adult caregivers, because they

worried about whether or not their health sta-

tus would allow them to provide care for their husband or wife. Moreover, the older adult

caregivers worried about who would care for

their husband or wife if they could not do so in the future because of their own declining health. Our study, unlike other research about care transitions, emphasized these unique aspects of care transitions experienced by

older adult spousal caregivers.

Our findings contribute to the growing body of literature aimed at demonstrat-

ing the importance of needs assessments for family caregivers (Guberman, Keefe,

Fancey, & Barylak, 2007; Nolan, Lundh,

Grant, &Keady, 2003) by illustrating the

fluctuating medical, physical, emotional, and

social needs of spousal caregivers during the transition of their relative from the GRU to home. However, in addition to assessing caregiver needs, the strategies engaged in

during hospital-to-home transitions might be an important part of a comprehensive caregiver assessment, and could be amenable

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 315

to intervention (e.g., when caregivers were

informed, they were able to enable physical

health). Whereas the assessment of “needs” is

critical, recognizing that caregivers are engag-

ing in multiple strategies to meet these needs during the transition from hospital to home also is essential. In addition to the changing types of needs of caregivers over time (Bull, 1990; Grimmer et al., 2004; Shyu, 2000b),

our findings highlight how needs fluctuate in intensity over time. Several caregivers

reported low levels of need prior to leaving

the GRU, but once they returned home with

their spouse their needs intensified. Thus,

whereas the GRU is an ideal place in the con-

tinuum of care to ascertain caregiver needs,

the process of needs assessment itself needs to be ongoing, not a one-time endeavor.

Aside from shielding, which caregivers to spouses with CI or dementia engaged in more

frequently than other caregivers, the types

of processes enacted by spousal caregivers to individuals with CI or dementia were

relatively similar to those engaged in by care- givers to individuals without CI or dementia. However, the intensity of the need to engage

in the processes differentiated these two groups. Caregivers of individuals with demen-

tia often discussed more unknowns, partic- ularly around the disease progression and disease-related medications. These caregivers

required increased efforts to navigate, and needed to create a knowledge base that was much more diverse than that required of the other caregivers. These two findings are con-

sistent with the broader caregiving—dementia literature which highlights that caregiving for those with dementia often is more demanding

than caring for individuals without dementia

(Ory, Hoffman, Yee, Tennstedt, & Schulz,

1999). The care recipients in this study who had dementia were in the mild-tomoderate clinical stages, as is the case for the major-

ity of those on geriatric rehabilitation units (Wells, Seabrook, Stolee, Borrie, & Knoefel,

2003). Therefore, different experiences for

those caring for individuals with and without

Cl or dementia might not be as salient within

the context of this study.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

316 APPENDIXG #® Care Transition Experience of Spousal Caregivers

Although gender differences are not identi- fied in transitional care literature, research in

the broader caregiving literature suggests that

for caregiving wives, the exchange of emo-

tional support with their care recipient hus- bands is related to decreased caregiver burden

and higher levels of marital satisfaction, and that wife caregivers are more depressed and

report higher levels of burden (Pruchno &

Resch, 1989; Wright & Aquilino, 1998). In

our study, both men and women discussed changes to their relationships; however,

women were more apt to comment on the loss

of conversation, missing how “life used to be,” were more apt to discuss power differen- tials that developed within their relationship,

and were more likely to identify shifts from

partnership in marriage to dependency (e.g.,

Eileen, who described her relationship as akin

to a parent-child relationship). This finding is similar to those of Jansson, Nordberg, and

Grafstrom (2001), who reported that spousal

caregivers undergo a transition from being

an equal partner in marriage to “caregiver,”

requiring caregivers to sacrifice their own

time to take care of their husband or wife.

These findings point to a need for health care professionals to work with both husband and wife caregivers, paying careful attention

to the emotional and relationship needs of

caregiving wives, and ensuring that both men

and, particularly women spousal caregivers,

are assisted in shifting the boundaries they set for themselves around their own activities and participation.

Two prominent care-transition interven-

tions for patients (Coleman et al., 2004;

Naylor et al., 2004; Parry, Coleman, Smith,

Frank, & Kramer, 2003) have demonstrated

promising results for patient (e.g., positive

perception of quality of care) and health

care system outcomes (decreased rehospi-

talization). Whereas family caregivers were identified as integral to the success of both interventions, and were involved in the imple- mentation of these interventions, their expe-

riences with the transition intervention and

their outcomes were not included. The effec-

tiveness of these interventions for influencing

caregiver experiences or outcomes during the transition of relatives from hospital to home is not known. Coleman and Williams (2007)

proposed an approach to involve caregivers

in transitional care that defined the type and intensity of roles that caregivers play; namely, the types of contributions caregivers make,

including financial, advocacy, care coordi- nation, emotional support, and direct care provision (creating the acronym FACED).

Acknowledging the role of caregivers, and

providing information to health care provid- ers about the contributions of caregivers, is

important to transitional care. What has not been emphasized adequately in this approach is how the care transition and potential transi-

tion interventions influence outcomes specific to caregivers, such as their own feelings of preparation and physical, psychological,

and social health. Caregivers have their own unmet needs that occur during transition. A focus for future studies might include how to fulfill caregivers’ needs, and to help them engage in the strategies they are using to care for their spouse, themselves, and the marital

dyad. Such a focus would be critical to the

design of interventions aimed at improving

caregiver-specific outcomes. Shyu and colleagues (2008) designed a

caregiver oriented transition intervention that included individualized health education, fol-

low-up phone calls, and home visits for family caregivers following the discharge of their relative from a hospital setting. They demon- strated how focusing on caregiver-specific needs resulted in better self-evaluations of preparation, and better satisfaction of dis- charge needs after the intervention. Our the-

oretical framework might be useful to inform

the development of future caregiver-oriented

interventions during transition from a GRU

to home, aimed at helping caregivers with what they are “doing” during transitions. For instance, interventions aimed at helping care- givers to navigate, safekeep, and reposition,

with a focus on ways to enhance and improve

the strategies engaged in by caregivers, would provide meaningful and useful skills and approaches.

on APPENDIXG @

Although the purpose of the present study was to highlight the experiences of spousal

caregivers through transition from a GRU to home, a potential limitation is that the care recipient spouse was not interviewed.

Changes in the nature of the relationship between caregivers and care recipients during the transition from hospital to home have been identified in previous studies (Shyu,

2000b, 2000c). In addition, our limited

consideration of the complexity of social networks—in particular how the social

interactions between spousal caregivers; care

recipients and other family members (e.g.,

adult children); friends; and formal care pro-

viders might shape the phases and processes of reconciliation—is a limitation. Future research should expand the focus to include

other individuals in the social networks of spousal caregivers to understand better the

complexity of interactions and processes

involved during care transitions. Our research provides insight into the importance of con- sidering the trajectory of multiple care tran- sitions experienced by caregivers. However,

further research is needed that incorporates a longitudinal perspective whereby caregiv-

ers are recruited in acute care settings and

followed through multiple care transitions across the care continuum. Another limita-

tion, and an implication for future research,

is that our study did not include caregiv-

ers from a range of cultural backgrounds, thereby limiting a consideration of how the experiences and processes might be different for caregivers in non-Western cultures (Li &

Shyu, 2007). The theoretical framework developed

in this study provides a means of under- standing the relationships and patterns

among the processes engaged in by care- givers during the period of their relative’s transition from a GRU to home. Helping

caregivers to reconcile and meet their

transitional-based needs will require a

commitment on the part of both GRU team members and community health care

professionals. The theoretical framework provides a resource to health care scientists,

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 317

health care clinicians, educators, and deci- sion makers regarding how they must work together to improve transitional care for spousal caregivers.

ACKNOWLEDGMENTS

We thank the caregivers, GRU clinicians, and

research team for their invaluable contribu-

tions to the study. The guidance and support of Ingrid Connidis and Margaret Cheesman is also acknowledged. We thank Catherine

Craven for her help with the preparation of this article.

DECLARATION OF CONFLICTING INTERESTS

The authors declared no conflicts of interest

with respect to the authorship and/or publica- tion of this article.

FUNDING

The authors disclosed receipt of the follow-

ing financial support for the research and/ or authorship of this article: Dr. Byrne was funded by a doctoral award from the Social

Sciences and Humanities Research Council of Canada, and a Graduate Research Award

from the Alzheimer Society of London

Middlesex.

NOTE

1. All participant names are pseudonyms.

Kerry Byrne, PhD, is a postdoctoral fellow in the

Department of Sociology at the University of British Columbia, Vancouver, British Columbia,

Canada. Joseph B. Orange, PhD, is an associate professor in

and the director of the School of Communication

Sciences and Disorders in the Faculty of Health

Sciences at the University of Western Ontario at

London, Ontario, Canada.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

318 APPENDIXG ® Care Transition Experience of Spousal Caregivers

Catherine Ward-Griffin, RN, PhD, is a professor

and acting chair of graduate programs in the Arthur Labatt Family School of Nursing, the

University of Western Ontario, London, Ontario,

Canada.

Corresponding Author: Kerry Byrne, University of British Columbia Department of Sociology, 1314-6303 N.W. Marine Drive, Vancouver, British Columbia, V6T 171,

Canada Email: [email protected]

REFERENCES Aminzadeh, F., Byszewski, A., Dalziel, W. B., Wilson, M.,

Deane, N., & Papahariss-Wright, S. (2005). Effective-

ness of outpatient geriatric assessment programs: Ex-

ploring caregiver needs, goals, and outcomes. Journal of Gerontological Nursing, 31(12), 19-25. Retrieved

from http://www.jognonline.com/view.asp?rid=46 73 Ballinger, C. (2004). Writing up rigour: Repre-

senting and evaluating good scholarship in

qualitative research. British Journal of Occupa- tional Therapy, 67, 540-546. Retrieved from http://www.ingentaconnect.com/content/cot/

bjot/2004/00000067/00000012/art00004 Barnes, B., Given, C., & Given, B. (1992). Caregivers

of elderly relatives: Spouses and adult children. Health and Social Work, 17, 282-289. Retrieved

from http://www.ncbi.nlm.nih.gov/pubmed/1478554 Beck, C. T. (1993). Qualitative research: The evalu-

ation of its credibility, fittingness and auditability. Western Journal of Nursing Research, 15, 263-266. doi:10.1177/019394599301500212

Bogardus, S. T., Jr., Bradley, E. H., Williams, C. S.,

Maciejewski, P. K., Gallo, W. T., & Inouye, S. K.

(2004). Achieving goals in geriatric assessment: Role

of caregiver agreement and adherence to recommen-

dations. Journal of the American Geriatrics Society, 52, 99-105. doi:10.1111/j.1532-5415.2004.52017

Bradley, E. H., Bogardus, S. T., Jr., van Doorn, C.,

Williams, C. S., Cherlin, E., & Inouye, S. K. (2000).

Goals in geriatric assessment: Are we measuring

the right outcomes? Gerontologist, 40, 191-196. doi:10.1093/geront/40.2.191

Braun, M., Mikulincer, M., Rydall, A., Walsh, A.,

& Rodin, G. (2007). Hidden morbidity in cancer:

Spouse caregivers. Clinical Oncology, 25, 4829- 4834. doi:10.1200/JCO.2006.10.0909

Bull, M. J. (1990). Factors influencing fam- ily caregiver burden and health. Western Journal of Nursing Research, 12, 758-770. doi:10.1177/019394599001200605

Bull, M. J. (1992). Managing the transition from hospi- tal to home. Qualitative Health Research, 2, 27-41.

doi:10.1177/104973239200200103

Bull, M. J., & Jervis, L. L. (1997). Strategies used by chronically ill older women and their caregiving daughters in managing posthospital care. Journal of Advanced Nursing, 25, 541-547. doi:10.1046/

j.1365-2648.1997.1997025541 Bull, M. J., Maruyama, G., & Luo, D. (1995). Testing

a model for posthospital transition of family care- givers for elderly persons. Nursing Research, 44, 132-138. Retrieved from http://journals.lww.com/ nursingresearchonline/Abstract/1995/05000/Test- ing_a_ Model_for_Posthospital_Transition_of.2.aspx

Bull, M. J., & McShane, R. E. (2008). Seeking what’s

best during the transition to adult day health services. Qualitative Health Research, 18, 597-605.

doi:10.1177/1049732308315174 Byrne, K. (2008). Spousal caregivers’ during their

husbands’/wives’ transition from a GRU to home. (Unpublished doctoral dissertation). University of Western Ontario, London, ON, Canada.

Chappell, N. L. (1992). Social support and aging. Toronto, ON, Canada: Butterworths.

Charmaz, K. (2006). Constructing grounded theory: A practical guide through qualitative analysis. Thou- sand Oaks, CA: Sage.

Chick, N., & Meleis, A. I. (1986). Transitions: A

nursing concern. In Chinn, P.L. (Ed.), Nursing re-

search methodology: Issues and implementation (pp. 237-257). Rockville, MD: Aspen.

Chiovitti, R. F., & Piran, N. (2003). Rigour

and grounded theory research. Journal of Ad- vanced Nursing,44, 427-435. doi:10.1046/

j-.0309-2402.2003.02822 Coleman, E. A., Boult, C., & American Geriatrics

Society Health Care Systems Committee, . (2003).

Improving the quality of transitional care for persons with complex care needs. Journal of the American Geriatrics Society, 51, 556-557. doi:10.1046/

j-1532-5415.2003.51186 Coleman, E. A., Smith, J. D., Frank, J. C., Min, S. J.,

Parry, C., & Kramer, A. M. (2004). Preparing pa-

tients and caregivers to participate in care delivered across settings: The care transitions intervention.

Journal of the American Geriatrics Society, 52, 1817-1825. doi:10.1111/}.1532-5415.2004.52504

Coleman, E. A., & Williams, M. V. (2007). Exe-

cuting highquality care transitions: A call to do it

right. Journal of Hospital Medicine, 2, 287-290. doi:10.1002/jhm.276

Connell, C. M., Janevic, M. R., & Gallant, M. P.

(2001). The costs of caring: Impact of dementia on

family caregivers. Journal of Geriatric Psychiatry, 14, 179-187. doi:10.1177/089198870101400403

Cutcliffe, J. R. (2000). Methodological issues in grounded theory. Journal of Advanced Nursing, 31, 1476-1484. doi:10.104 6/).1365-2648.2000.01430

Davies, S., & Nolan, M. (2003). ‘Making the best of

things’: Relatives’ experiences of decisions about care-home entry. Ageing & Society, 23, 429-450. doi:10.1017/S0144686X03001259

= APPENDIXG &

Davies, S., & Nolan, M. (2004). Making the move:

Relatives’ experiences of transition to a care home. Health and Social Care in the Community, 12,

517-526. doi:10.1111/}.1365-2524.2004.00535 Demers, L., Ska, B., Desrosiers, J., Alix, C., &

Wolfson, C. (2004). Development of a conceptual framework for the assessment of geriatric reha- bilitation outcomes. Archives of Gerontology and Geriatrics, 38, 221-237. doi:10.1016/j.arch- ger.2003.10.003

Elder, G. H., Jr. (1998). The life course and human de-

velopment. In Lerner, R. M. (Ed.), Handbook of child

psychology: Volume 1. Theoretical models of human development (pp. 939-991). New York: Wiley.

Elder, G. H., Jr., & Johnson, M. K. (2003). The life course and aging: Challenges, lessons, and new directions. In Setterson,, R. A. Jr. (Ed.), Invitation to

the life course: Toward new understandings of later life (pp. 48-81). Amityville, NY: Baywood.

Firbank, O. E., & Johnson-Lafleur, J. (2007). Older

persons relocating with a family caregiver: Processes,

stages, and motives. Journal of Applied Gerontology, 26, 182-207. doi:10.1177/0733464807300224

Frederick, J., & Fast, J. (1999). Eldercare in Canada:

Who does how much? Canadian Social Trends, 53,

26-32. Retrieved from http://www.statcan.gc.ca/ pub/11-008-x/1999002/article/4661-eng.pdf

Fredman, L., & Daly, M. P. (1998). Enhancing practi-

tioner ability to recognize and treat caregiver phys-

ical and mental consequences. Topics in Geriatric

Rehabilitation, 14, 36-44.

George, L., & Gwyther, L. (1986). Caregiver well- being: A multidimensional examination of family caregivers of demented adults. Gerontologist, 26, 253-259. doi:10.1093/geront/26.3.253

Grant, S., St John, W., & Patterson, E. (2009).

Recovery from total hip replacement surgery: “It’s

not just physical.” Qualitative Health Research, 19, 1612-1620. doi:10.1177/1049732309350683

Grimmer, K., Falco, J., & Moss, J. (2004). Becoming

a carer for an elderly person after discharge from an acute hospital admission. Internet Journal of Allied Health Sciences & Practice, 2(4). Retrieved from

http://ijahsp.nova.edu/articles/vol2num4/grimmer- carer % 20issues. pdf

Grimmer, K., & Moss, J. (2001). The development,

validity and application of a new instrument to assess the quality of discharge planning activities from the community perspective. International Journal for Quality in Health Care, 13, 109-116. Retrieved from http://intqhc.oxfordjournals.org/cgi/reprint/13/2/109

Guba, E., & Lincoln, Y. (1989). Fourth generation

evaluation. Beverly Hills, CA: Sage. Guberman, N., Keefe, J., Fancey, P., & Barylak, L.

(2007). ‘Not another form!’: Lessons for imple-

menting carer assessment in health and social service agencies. Health and Social Care in the Community, 15, 577-587. doi:10.1111/).1365— 2524.2007.00718.x

Reprinted

with permission.

Care Transition Experience of Spousal Caregivers 319

Hayes, J., Zimmerman, M., & Boylstein, C.

(2010). Responding to the symptoms of Alzhei- mer’s disease: Husbands, wives, and the gen- dered dynamics of recognition and disclosure. Qualitative Health Research, 20, 1101-1115. doi:10.1177/1049732310369559

Health Canada. (2002). National profile of family caregivers in Canada—Final report. Retrieved from http://www.hc-sc.gc.ca/hes-sss/pubs/ home-domicile/2002-caregiv-interven/ index-eng.php

Hess, B. B., & Soldo, B. J. (1985). Husband and wife

networks. In Sauer, W. J. & Coward, R. T. (Eds.),

Social support networks and the care of the elderly: Theory, research and practice (pp. 67-92). New York: Springer.

Hills, G. A. (1998). Caregivers of the elderly: Hidden

patients and health team members. Topics in Geriat- ric Rehabilitation, 14, 1-11.

Holland, D. E., & Harris, M. R. (2007). Discharge planning, transitional care, coordination of care,

and continuity of care: Clarifying the concepts and terms from the hospital perspective. Home Health Care Services Quarterly, 26(4), 3-19. doi:10.1300/

J027v26n04_02

Holtslander, L. F., & Duggleby, W. D. (2009).

The hope experience of older bereaved women who cared for a spouse with terminal cancer. Qualitative Health Research, 19, 388-400. doi:10.1177/1049732308329682

Jacobi, C. E., van den Berg, B., Boshuizen, H. C.,

Rupp, I., Dinant, H. J., & van den Bos, A. M.

(2003). Dimensionspecific burden of caregiving among partners of rheumatoid arthritis patients. Rheumatology, 42, 1226-1233. doi:10.1093/rheu- matology/keg366

Jansson, W., Nordberg, G., & Grafstrom, M. (2001).

Patterns of elderly spousal caregiving in dementia care: An observational study. Journal of Advanced Nursing, 34, 804-812. Retrieved from http://www3.

interscience.wiley.com/cgi-bin/fulltext/118983178/

PDFSTART

Kane, R. A., Reinardy, J., Penrod, J. D., & Huck, S.

(1999). After the hospitalization is over: A different perspective on family care of older people. Journal

of Gerontological Social Work, 31, 119-141. doi:10.1300/J083v31n01_08

Kneeshaw, M. F., Considine, R. M., & Jennings, J.

(1999). Mutuality and preparedness of family care- givers for elderly women after bypass surgery. Applied Nursing Research, 12, 128-135. doi:10.1016/S0897-1897(99)80034-2

Lazarus, R. S., & Folkman, S. (1984). Stress, appraisal,

and coping. New York: Springer. Li, H. J., & Shyu, Y. I. (2007). Coping processes

of Taiwanese families during the postdischarge period for an elderly family member with hip fracture. Nursing Science Quarterly, 20, 273-279.

doi:10.1177/0894318407303128

Generating and Assessing Evidence for Nursing Practice (11th ed.)

320 APPENDIXG #® Care Transition Experience of Spousal Caregivers

Isa, 1B, Cr, Jets, ©. Sh, Iiaiy, IML isk, Caen, S, Wo, &¢ Jong, S. Y. (2006). Care needs and level of care diffi-

culty related to hip fractures in geriatric populations during the post-discharge transition period. Journal of Nursing Research, 14, 251-259. doi:10.1097/01. JNR.0000387584.89468.30

Lofland, J., Snow, D., Anderson, L., & Lofland, L.

H. (2006). Analyzing social settings: A guide to qualitative observation and analysis. Florence, KY:

Wadsworth. Meleis, A. I., Sawyer, L. M., Im, E. O., Hilfinger Mes-

sias, D. K., & Schumacher, K. (2000). Experiencing

transitions: An emerging middle-range theory. Advances in Nursing Science, 23, 12-28. Retrieved from http://journals.lww.com/advancesinnursing- science/Abstract/2000/09000/Experiencing_Transi-

tions__An_Emerging Middle_Range.6.aspx

Morse, J. M. (2009). Exploring transitions.

Qualitative Health Research, 19, 431.

doi:10.1177/1049732308328547 Morse, J. M., & Field, P. A. (1995). Qualitative

research methods for health professionals. Thousand Oaks, CA: Sage.

Navon, L., & Weinblatt, N. (1996). The show must go

on—Behind the scenes of elderly spousal caregiving. Journal of Aging Studies, 10, 329-342. doi:10.1016/ S0890-4065(96)90005-5

Naylor, M. D. (2000). A decade of transitional

care research with vulnerable elders. Journal of Cardiovascular Nursing, 14(3), 1-14. Re-

trieved from http://ovidsp.tx.ovid.com/sp-3.2/ ovidweb.cgi? &S=HLANFPLFEGDDDKLCNC- DLDCGCECHNAA00 &Link+Set=S. sh.15.17.22.27%7c4%7csl_10

Naylor, M. D. (2002). Transitional care of older adults. Annual Review of Nursing Research, 20, 127-147.

Retrieved from http://www.ingentaconnect.com/ content/springer/arnr/2002/00000020/00000001/ art00007

Naylor, M. D., Brooten, D. A., Campbell, R. L.,

Maislin, G., McCauley, K. M., & Schwartz,

J. S. (2004). Transitional care of older adults

hospitalized with heart failure: A randomized, controlled trial. Journal of the American Geriat- rics Society, 52, 675-684. doi:10.1111/).1532--

5415.2004.52202.x Naylor, M. D., Hirschman, K. B., Bowles, K. H.,

Bixby, M. B., Konick-McMahan, J., & Stephens, C. (2007). Care coordination for cognitively impaired older adults and their caregivers. Home Health Care Services Quarterly, 26(4), 57-78. doi:10.1300/

J027v26n04_05 Naylor, M. D., Stephens, C., Bowles, K. H., &

Bixby, M. B. (2005). Cognitively impaired older adults: From hospital to home. American Journal of Nursing, 105, 52-61. Retrieved from http:// journals.lww.com/ajnonline/Citation/2005/02000/ Cognitively_Impaired_Older_Adults__From Hospital.28.aspx

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Nolan, M. R.,, Lundh, U.,, Grant, G.,, & Keady, J,.

(Eds.). (2003). Partnerships in family care: Under- standing the caregiving career. Maidenhead, UK:

Open University Press.

Ory, M. G., Hoffman, R. R., Yee, J. L., Tennstedt, S., & Schulz, R. (1999). Prevalence and impact of

caregiving: A detailed comparison between dementia

and nondementia caregivers. Gerontologist, 39,

177-185. doi:10.1093/geront/39.2.177 Parry, C., Coleman, E. A., Smith, J. D., Frank, J., &

Kramer, A. M. (2003). The care transitions inter-

vention: A patient-centered approach to ensuring effective transfers between sites of geriatric care. Home Health Care Services Quarterly, 22(3), 1-17.

doi:10.1300/J027v22n03_01 Parry, C., Kramer, H. M., & Coleman, E. A. (2006).

A qualitative exploration of a patient-centered coaching intervention to improve care transitions

in chronically ill older adults. Home Health Care Services Quarterly, 25(3-4), 39-53. doi:10.1300/

J027v25n03_03 Pearlin, L. I., Mullan, J. T., Semple, S. J., & Skaff,

M. M. (1990). Caregiving and the stress pro- cess: An overview of concepts and their mea- sures. Gerontologist, 30, 583-594. doi:10.1093/ geront/30.5.583

Pruchno, R. A., & Resch, N. (1989). Husbands and

wives as caregivers: Antecedents of depression and burden. Gerontologist, 29, 159-165. doi:10.1093/ geront/29.2.159

Redfern, S. J., & Norman, I. J. (1994). Validity

through triangulation. Nurse Researcher, 2, 41-56. Reuss, G. F., Dupuis, S. L., & Whitfield, K. (2005).

Understanding the experience of moving a loved one to a long-term care facility: Family members’ perspectives. Journal of Gerontological Social Work, 46, 17-46. doi:10.1300/J083v46n01_03

Sandelowksi, M. (1993). Rigor or rigor mortis—The problem of rigor in qualitative research revisited. Advances in Nursing Science, 16(2), 1-8.

Schumacher, K. L. (1995). Family caregiver role

acquisition: Role-making through situated inter- action. Scholarly Inquiry for Nursing Practice, 9, 211-226.

Schumacher, K. L., Jones, P. S., & Meleis, A. (1999).

Helping elderly persons in transition: A framework for research and practice. In Swanson, E. & Tripp- Reimer, T. (Eds.), Life transitions in the older adult:

Issues for nurses and other health professionals (pp. 1-26). New York: Springer.

Showalter, A., Burger, S., & Salyer, J. (2000). Patients’ and their spouses’ needs after total joint arthroplasty: A pilot study. Orthopaedic Nursing, 19, 49-62.

Shyu, Y. I. (2000a). The needs of family caregivers of frail elders during the transition from hospital to home: A Taiwanese sample. Journal of Advanced Nursing, 32, 619-625. Retrieved from http://www3. interscience.wiley.com/cgi-bin/fulltext/119010648/ PDFSTART

Reprinted

with permission.

ey APPENDIXG &

Shyu, Y. I. (2000b). Role tuning between caregiver and care receiver during discharge transition: An illus- tration of role function mode in Roy’s adaptation theory. Nursing Science Quarterly, 13, 323-331.

doi:10.1177/08943180022107870 Shyu, Y. I. (2000c). Patterns of caregiving when family

caregivers face competing needs. Journal of Advanced Nursing, 31, 35-43. Retrieved from http://www3. interscience.wiley.com/journal/121440743/abstract

Shyu, Y. L., Chen, M., Chen, S., Wang, H., & Shao,

J. (2008). A family caregiver-oriented discharge planning program for older stroke patients and their family caregivers. Journal of Clinical Nursing, 17, 2497-2508. Retrieved from http://www3.interscience. wiley.com/cgi-bin/fulltext/121377510/PDFSTART

Skaff, M. M., Pearlin, L. I., & Mullan, J. T. (1996). Transitions in the caregiving career: Effects on sense of mastery. Psychology and Aging, 11, 247-257.

with permission.

Care Transition Experience of Spousal Caregivers 321

Wells, J. L., Seabrook, J. A., Stolee, P., Borrie, M. J.,

& Knoefel, F. (2003). State of the art in geriatric re-

habilitation. Part II: Clinical challenges. Archives in Physical Medicine and Rehabilitation, 84, 898-903. doi:10.1016/S0003-9993(02)04930-4

Wright, D. L., & Aquilino, W. S. (1998). Influence of

emotional support exchange in marriage on caregiv- ing wives’ burden and marital satisfaction. Family Relations, 47, 195-204. Retrieved from http://www. jstor.org/stable/5 85624 ?cookieSet=1

Kluwer. Polit & Beck: Resource Manual for Nursing Research:

Generating and Assessing Evidence for Nursing Practice (11th ed.)

A RANDOMIZED CONTROLLED TRIAL OF AN INDIVIDUALIZED

PREOPERATIVE EDUCATION INTERVENTION FOR SYMPTOM MANAGEMENT AFTER TOTAL KNEE ARTHROPLASTY Rosemary A. Wilson e Judith Watt-Watson e Ellen Hodnett

Joan Tranmer

Pain and nausea limit recovery after total knee arthroplasty (TKA) patients. The aim

of this study was to determine the effect of a

preoperative educational intervention on post-

surgical pain-related interference in activities,

pain, and nausea. Participants (7 = 143) were

randomized to intervention or standard care. The standard care group received the usual teaching. The intervention group received the

usual teaching, a booklet containing symp- tom management after TKA, an individual

teaching session, and a follow-up support call. Outcome measures assessed pain, pain interference, and nausea. There were no dif-

ferences between groups in patient outcomes. There were no group differences for pain

at any time point. Respondents had severe

postoperative pain and nausea and received

inadequate doses of analgesia and antiemet-

ics. Individualizing education content was

insufficient to produce a change in symptoms

for patients. Further research involving the modification of system factors affecting the

provision of symptom management interven-

tions is warranted.

& Introduction

In Canada, more than 42,000 total knee

arthroplasty (TKA) surgeries were performed

from 2012 from 2013 (Canadian Institute for

Health Information, 2014). TKA is a com-

mon, successfully performed joint replacement

procedure for pain and immobility associated

with knee joint compromise. Arthritis is the

most common preoperative diagnosis (95.4%

osteoarthritis and 2.2% rheumatoid arthri-

tis). The purpose of joint replacement for

these patients is to reduce pain and knee joint

stiffness, and thereby increase mobility and function.

Pain and nausea are common symptoms

for patients after this procedure. Moderate to

severe pain on movement and at rest has been

documented during the first 3 postoperative

days (Brander et al., 2003; Salmon, Hall,

Perrbhoy, Shenkin, & Parker, 2001; Strassels,

Chen, & Carr, 2002; Wu et al., 2003).

Similarly, nausea has been found to be worse

322 Reprinted with permission from Wilson, R. A., Watt-Watson, J., Hodnett, E., and Tranmer, J. (2016), A randomized controlled trial of an individualized preoperative education intervention for symptom management after total knee

arthroplasty. Orthopaedic Nursing, 35(1), 20-29.

APPENDIXH &

on postoperative day 1, but has the greatest

impact on patients on day 2 (Wu et al., 2003).

Previous research (Beaupre, Lier, Davies,

& Johnston, 2004; Bondy, Sims, Schroeder,

Offord, & Narr, 1999; Lin, Lin, & Lin, 1997; McDonald, Freeland, Thomas, & Moore,

2001; McDonald & Molony, 2004; McDonald,

Thomas, Livingston, & Severson, 2005; Roach,

Tremblay, & Bowers, 1995; Sjoling, Nordahl,

Olofsson, & Asplunf, 2003) has explored education interventions for pain prevention

and treatment in the TKA population. These trials used a variety of delivery methods for the intervention including video, pamphlets, and

classroom sessions, and the impact on pain

outcomes was variable. Three studies reported

that the education intervention resulted in moderately lower pain scores (McDonald & Molony, 2004, McDonald et al., 2001, Sjoling

et al., 2003). Despite the relationship between pain and nausea and their prevalence after TKA,

none of the studies addressed analgesic pain

management or antiemetic therapy.

Many factors may impact the effectiveness

of the preoperative education intervention,

including timing and content. Stern and

Lockwood (2005), in a systematic review

of 15 randomized controlled trials (RCTs),

concluded that preadmission written material

combined with verbal instruction was more

effective and resulted in better performance of postoperative exercises or skills than informa-

tion provided postoperatively. A systematic review of 13 studies (Louw, Diener, Butler, &

Puentedura, 2013) indicated that preoperative

education, which focused on pain communt-

cation and management strategies, may result

in better patient outcomes than education

focused on pathophysiology. Preoperative education for patients with TKA had a signif- icant, positive effect in one study (McDonald et al., 2001). The authors hypothesized that

this was due to the difference in educational content of the intervention: a focus on pain

management and communication rather than

the anatomy and physiology of the surgery. Louw et al. (2013) advised more investigation

regarding the content of educational interven- tions associated with TKA. Further, Wallis and

Reprinted

with permission.

Preoperative Education Intervention for Symptom Management After TKA 323

Taylor (2011) conducted a systematic review and meta-analysis of 23 RCTs involving both patients with hip and knee replacement. The metaanalysis (7 = 2) included 99 participants and provided minimal quality evidence that preoperative exercise combined with educa- tion leads to quicker return to mobility and activity after joint replacement, compared with

standard preoperative care (standard mean difference = 0.50 [0.10, 0.90]).

Education that includes ways for patients

to communicate pain and underlines the use

of pain management strategies, including

analgesics, has been used in other patient

groups. Watt-Watson et al. (2004) addressed

common patient concerns with taking analge- sics in addition to reviewing the importance

of pain relief and pain communication in a study of 406 patients with coronary artery bypass. Patients in the intervention group reported fewer concerns about taking anal-

gesics (22.6 + 14.7 vs. 18.5 + 14.1, p < .0S5)

and fewer concerns about addiction (3.7 + 3.6

vs. 4.8 + 3.8). The finding that most patients would not ask for analgesics, despite having fewer concerns about addiction and taking

analgesics because they expected clinicians to

know when these were needed, suggested that discussion of these beliefs about postoperative symptom management would be important

for TKA patients, as well. An individualized preoperative education

approach has been used successfully to reduce

symptoms in patients with cancer (Benor,

Delbar, & Krulik, 1998; DeWit et al., 2001;

Sherwood et al., 2005; Velji, 2006; Yates et al.,

2004). Further, systematic reviews have recom-

mended individualization of preoperative edu- cational content (Johansson, Nuutila, Virtanen,

Katajisto, & Salantera, 2005; McDonald,

Page, Beringer, Wasiak, & Sprowson, 2014).

However, no studies were found that used an

individualized approach to preoperative patient

education for patients with TKA. Therefore, the intervention used in this

trial was designed to be an individualized,

preoperative approach to patient education

and was informed by an adaptation of Wilson

and Cleary’s (1995) conceptual model of

Generating and Assessing Evidence for Nursing Practice (11th ed.)

324 APPENDIXH ® PreoperativeEducationInterventionforSymptomManagementAfterTKA

Characteristics of the Individual

Age, sex, educational level

Symptoms Function

Interference

with activity

(BPI-I, TKA-

AQ)

Pain (MPQ-SF)

Nausea (ONI) .

Intervention

Pain and nausea communication

Analgesic use Anti-emetic use

Non-pharmacologic strategies

Figure 1. Conceptual framework: adaptation of Wilson and Cleary’s (1995) model.

patient outcomes (Figure 1). The intervention = Methods

focused on patient communication for pain

management, analgesic use, and antiemetic

use (see Table 1). This study aimed to inves- TRIAL DESIGN tigate the impact of an individually deliv-

ered preoperative education intervention on An RCT design was used to evaluate put pain-related interference, pain, and nausea for comes on the first, second, and third days patients undergoing unilateral TKA. after TKA surgery (see Figure 2). This trial

was conducted at an academic health sci-

ences center in Southeastern Ontario. Ethics

approval was obtained from the associated

university’s Research Ethics Board and the Trial Site Hospital’s Research Ethics Board.

@ Research Questions

¢ Primary research question: What is the

effect of an individualized preoperative STUDY PARTICIPANTS education intervention for patients with

TKA on pain-related interference with Patients were included if they were scheduled usual activities on postoperative day 3? for elective unilateral primary TKA using?

¢ Secondary research question: What is the planned intrathecal (spinal) anesthetic tech- effect of an individualized preoperative edu- nique; had grade I-II American Society of

cation intervention for patients with TKA on Anesthesiologists Physical Status Classification

nausea, pain, and analgesic and antiemetic (Larson, 1996); were able to speak and under- administration on postoperative days 1, 2, stand English; were able to be reached by tele-

and 3? phone; were planned for home discharge; and

APPENDIXH Preoperative Education Intervention for Symptom Management After TKA 325

Table 1 Pre-knee Symptom Education Intervention Content ee

Topic Supporting Evidence

Pain, importance of pain

management McDonald et al. (2001); Chang et al. (2005); Johnson, Rice,

Fuller, and Endress (1978); Lin et al. (1997); McDonald

et al. (2004); Melzack and Wall (1996); Sjoling et al.

(2003); Watt-Watson et al. (2004) Importance of pain management

to promote activity

Communicating pain to health

professionals

Asking for analgesics

McDonald et al.; Lin et al.; Sjoling et al.; Watt-Watson et al.

McDonald et al.; Johnson et al.; McDonald et al.; Sjoling

et al.; Watt-Watson et al.

McDonald et al.; Johnson et al.; Sjoling et al.; Lin et al.;

Watt- Watson et al.

Asking for antiemetics

Preventing dehydration (fluids)

Misbeliefs about taking

medication

Nonpharmaco-logical measures

consented to participate in this trial. Patients

were excluded if they were not expected to be discharged home, or were booked for hemi,

revision, or bilateral knee arthroplasty.

Recruitment took place at the weekly outpa-

tient orthopaedic preadmission testing clinic at

a facility affiliated with the trial center. Potential

participants were identified by clinic staff, and eligible patients were asked for their permission

by hospital staff to release their names to the investigator using a standardized script. The

trial research assistant gave all willing patients

a detailed verbal and written explanation of the

trial during their preadmission appointment.

Before randomization, written consent was

gained by the trial research assistant, who then collected baseline demographic characteristics and clinical information.

# Interventions

INTERVENTION: THE PRE-KNEE SYMPTOM EDUCATION INTERVENTION

The Pre-Knee Symptom Education interven-

tion was composed of three components: the

Reprinted

with permission.

Gan et al. (2003); Melzack and Wall

Hodgkinson et al. (2003); Phillips, Johnston, and Gray (1993)

Chang et al.; Watt-Watson et al.; Wilson, Goldstein,

VanDenKerkhof, and Rimmer (2005)

Melzack and Wall; Watt-Watson et al.

booklet, an individual teaching session, and a follow-up support telephone call. Content used in this intervention was drawn from

trials of preoperative education programs

in surgical patients (McDonald et al., 2001;

McDonald & Molony., 2004; Sjoling et

al., 2003; Watt-Watson et al., 2004) and

supported by focus groups’ findings of indi- individual areas of concern for patients with TKA (Chang et al., 2005). To ensure con-

cerns, found in the literature, were consistent

with those of patients with TKA at the trial site, pilot interviews of 10 patients were con- ducted on day 2 or 3 post-TKA surgery. The Pre-Knee Symptom Education Booklet was

reviewed with each consenting participant in an individualized, private teaching session

during the preoperative patient visit to the Pre- Surgical Screening (PSS) Centre. This

component was adapted from an educational tool used by Watt-Watson and colleagues

(2004) for relevance to TKA postoperative

recovery and the result of the pilot inter-

views done with local patients. The booklet

was 12 pages long and included the content provided in Table 1 in addition to diagrams, pictures, and a space for recording questions

for the investigator during the telephone

Generating and Assessing Evidence for Nursing Practice (11th ed.)

326 APPENDIXH ® PreoperativeEducationInterventionforSymptomManagementAfterTKA

Not eligible

No consent

Standard Care Group

Surgery

Outcomes

Day 1 - Pain, Nausea

Day 2 - Pain, Nausea

Day 3 - Pain, Nausea,

Interference with

Activity, Usual Activity

Eligibility Assessment

Consent

Baseline demographic data collection

Usual preoperative educational preparation

Intervention Group

Session, Pre-Knee Booklet

Telephone

follow-up call

Activity, Usual Activity ——

Individual Teaching

Outcomes

Day 1 - Pain, Nausea Day 2 - Pain, Nausea

Day 3 - Pain, Nausea,

Interference with

Figure 2. Schema of trial design.

follow-up call. The teaching session and

booklet review were provided in a quiet examination room. The principal investiga-

tor delivered all intervention components during the PSS clinic appointment within 4 weeks of surgery. New concerns identified

by trial participants as well as strategies pre-

sented were recorded on the Individualized Education Content Tool and reinforced during the follow-up support telephone call

along with discussion of any questions raised

by participants in the intervening time. The follow-up support telephone call occurred during the week before the scheduled surgical date. Questions asked by partici- pants focused on (a) use of the intravenous

patient-controlled analgesia (PCA-IV) pump, (b) concerns about the adverse effects of

opioid analgesics, (c) physiotherapy timing, (d) home discharge analgesia, and (e) pre-

surgical fasting guidelines and information regarding oral fluid intake.

APPENDIXH &

STANDARD CARE

Participants in both groups received stan-

dard care, including an educational session

provided by a physiotherapist outlining physiotherapy activities, a 30-minute video

explaining the surgical procedure and post-

operative orthopaedic routines, and a brief

review of the use of PCA-IV by clinic nursing staff.

OUTCOMES

Baseline demographic data were col-

lected using the self-reported Baseline Demographic Questionnaire before the intervention.

The primary outcome, pain interfer- ence, was measured using the Brief Pain

Inventory, Interference (BPI-I) subscale on

postoperative day 3 (Cleeland & Ryan, 1994). Pain-related interference, as mea-

sured by the BPI-I, refers to the extent to

which pain interferes with general activities,

sleep, mood, walking, movement from bed to chair, and relationships with others. This measure has well-established construct validity (Mendoza et al., 2004b, 2004a;

Tan, Jensen, Thornby, & Shanti, 2004;

Watt-Watson et al., 2004). Psychometric

testing of postoperative use of the BPI-I

demonstrates a consistent subscale struc-

ture between acute and chronic pain states

(Mendoza et al., 2004a, 2004b; Watt-

Watson et al., 2004; Zalon, 1999) as well

as sensitivity to change (Mendoza et al.,

2004a) and sex differences (Watt-Watson

et al., 2004). The use of the BPI-I in the

immediate postoperative period (Zalon,

1997) and beyond postoperative day 3 has been demonstrated (Mendoza et al., 2004a;

Watt- Watson et al., 2004). Two items were

deleted: “normal work” and “enjoyment

of life” as these items were not relevant to the early postoperative period. The addi-

tion of one item addressing the activity of transferring from bed to chair was added, and the modified tool was pilot tested on

Reprinted

with permission.

Preoperative Education Intervention for Symptom Management After TKA 327

the third postoperative day in a group of TKA patients (7 = 14). The additional item, transferring from bed to chair, was easily answered by all participants and similarly

judged to be an appropriate item for the administration time. Similar adaptation

of the BPI-I items took place in a study by

Watt-Watson et al. (2004) where both “nor-

mal work” and “enjoyment of life” were

deleted and “deep breathing and coughing” was inserted for use in a postoperative patient population. Cronbach’s « for this change was reported as .71.

Secondary outcomes included levels of

pain and nausea, and analgesic and anti- emetic use. Pain and pain quality were measured using the Short Form McGill Pain

Questionnaire (MPQ-SF) (Melzack, 1987;

Melzack et al., 1987). Nausea was measured

using the Overall Nausea Index (ONI), one

component of the Nausea Questionnaire (Melzack, 1989), used previously by Parlow

et al. (2004) in a trial of postoperative anti- ematic therapies.

Antiemetic and opioid administration

data were recorded from the chart for each of

postoperative days 1 to 3.

SAMPLE SIZE

Sample size for this trial was based on group means from another study (7 = 406) using the BPI-I as a primary outcome (Watt-Watson et

al., 2004). Using a moderate effect size of .5

based on between standard deviation and within standard deviation (Cohen, 1988), the

sample size required was 64 per arm (a = .0S, power = 80%). A reduction of half the stan-

dard deviation of the general population, as reported by Watt-Watson et al. (2004), is a

reasonable estimate of the clinically import- ant effect of this intervention. Minimal trial attrition was expected as all measurements

were taken during the inpatient hospital stay. A conservative estimate of 10% was used. As

a result the sample size required for this trial

was 140 in total, with an o level of .05 and

power of 80%.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

328 APPENDIXH #8

RANDOMIZATION AND BLINDING

Participants were randomly assigned to the intervention plus standard care group or

the standard care group using a randomiza- tion service provided by a research program not connected to this trial. Personnel at the

research office used a computer-generated block randomization table provided by statis- tical services. The research assistant called the research office number, provided the partici- pant number, and received group assignment

information. Group assignment was recorded

on the Baseline Demographics Questionnaire and was stored in a location separate from all

postoperative data collection forms. The intervention was initiated immedi-

ately after randomization for participants in the experimental group in a private room in the presurgical screening area. Although participants could not be unaware of group

allocation, the research assistants collecting

postoperative outcome data were blinded to

group allocation, reducing the potential for

cointervention or the introduction of bias by trial personnel during data collection.

STATISTICAL ANALYSIS

Results were analyzed using an intention-to-

treat approach. Baseline data were analyzed using descriptive statistics. A two-tailed level

of significance of .05 was used for all analy-

ses. Data were analyzed using the SPSS/PASW

software package, version 18.

Independent samples t test was used to

determine differences in pain-related interfer-

ence with activity between the intervention

and standard care groups on postopera- tive day 3 on total and component scores. Repeated measures-analysis of covariance

was used to determine differences between groups and over the measurement periods

in pain scores (MPQ-SF, Numeric Rating

Scale [NRS] questions), nausea scores (ONI),

and total 24-hour analgesic administration.

Differences in antiemetic administration

between the two groups were determined

Generating and Assessing Evidence for Nursing Practice (11th ed.)

PreoperativeEducationInterventionforSymptom ManagementAfterTKA

using y 2. Linear-by-linear y 2 was also used to detect differences in frequency of postoper- ative activities completed (TKA-AQ). Separate

analyses were conducted using participants,

rating moderate to severe worst pain and nau-

sea—scores of 4-10 (Jones et al., 2005)—in

the last 24 hours with antiemetic and analge-

sic administration.

# Results

A total of 337 patients were screened for participation in this trial (see Figure 3). Of these, 162 were eligible and only 19 of these

declined to participate. Therefore, 143 were randomized after

baseline demographic data collection in the preadmission phase of surgery preparation.

One participant in the standard care group

did not meet eligibility criteria at the time of surgery as a result of a change of procedure type (bilateral vs. unilateral TKA), and one participant in each group had the procedure

cancelled indefinitely. As a result, the total number for the analysis of baseline charac- teristics was 143 and 140 for postoperative

outcomes. No participants withdrew from the trial during data collection. Baseline demo- graphic data are included in Table 2.

Baseline characteristics were similar between groups with a mean age of 67 + 8

years in the intervention group and 66 + 8

years in the standard care group, consistent

with many studies of patients with TKA and national TKA data. The primary diagnosis requiring surgery was osteoarthritis in both groups, with approximately one third of participants requiring opioid analgesics for

arthritic pain preoperatively. z

PRIMARY RESEARCH QUESTION

Day 3 measurements of the BPI-I are pre- sented in Table 3. Total scores for the

standard care group (22.4 + 15.1) and the intervention group (24.4 + 14.4) were not

Reprinted

with permission.

APPENDIXH #8

Assessed for eligibility (n=337)

Randomized (n=143)

Preoperative Education Intervention for Symptom Management After TKA 329

Excluded (n=194)

+ Not meeting inclusion criteria (n=175) + Declined to participate (n=19) ¢ Other reasons (n=0)

Allocated to intervention (n=73)

+ Received allocated intervention (n=73)

Lost to follow-up (n=1) Procedure cancelled indefinitely (n=1)

Time 1 data analysed Time 2 data analysed n=66 Time 3 data analysed n=70° Chart review completed

S - Follow-Up. oe

Allocated to Standard Care Intervention (n=70)

¢ Received standard care (n=70)

Lost to follow-up (n= 2) Procedure cancelled indefinitely (n=1) Ineligible due to change in procedure (n=1)

Time 1 data analysed Time 2 data analysed n=63

Time 3 data analysed n=65° Chart review completed

Figure 3. Flow of participants through the trial. “Primary outcome.

significantly different (p = .45). Independent

sample ¢ tests were nonsignificant for all BPI-I items. Highest interference scores for both groups at day 3 were in the moderate range

and included general activity (standard care: 5.6 + 3.2; intervention: 5.8 + 3.2) and transfer

from bed to chair (standard care: 5.0 + 3.4;

intervention: 4.6 + 2.9). It is important to

note that these painrelated interference scores were measured on the third postoperative day, 1 day before the expected discharge date

for this group of patients.

Reprinted

with permission.

SECONDARY RESEARCH QUESTIONS

Pain. Postoperative pain was measured

using the MPQ-SF on each of postoperative

days 1, 2, and 3 (see Table 4). There were

no significant group differences on any of

the three postoperative days in either pain

right now at rest, pain now with movement, or worst pain in last 24 hours. There was, however, a significant effect for time in pain

right now at rest (p = .0002) and worst pain

last 24 hours (p = .013), with pain decreasing

Generating and Assessing Evidence for Nursing Practice (11th ed.)

330 APPENDIXH

Table 2 Baseline Demographics of Participants

Intervention Standard

(n=73) Care (n=70)

Demographics n(%) n(%)

Sex

Female 46 (63) 43 (61)

Home status

Live alone 13 (18) 15 (21)

Highest education

level

Less than high 34 (47) 36 (51)

school

Postsecondary 39 (53) 34 (49)

Home pain

medication

None 13 (18) 18 (26)

Opioid 21 (29) 24 (34)

Nonopioid 39 (53) 28 (40)

Preoperative

diagnosis

Osteoarthritis 70 (96) 67 (96)

Rheumatoid 3 (4) 3 (4)

arthritis

over time but not for the item, pain right now

when moving (p = .06). Similarly, there was a

significant effect for time in the Present Pain Intensity (PPI) global pain rating (0-5) (p =

.001) but no group difference across time (p = .70). As with the NRS and PPI, there was

a significant effect of time for both the PRI-S

(p = .02), the PRI-A (p = .05) and the PRI-T (p = .02), but there were no significant group differences across the three measurement

times. Across both groups, the average rating

of worst pain in the last 24 hours was 7 + 2.4, in the severe range on each of the three

postoperative days. Seventy-three percent of the total sample reported moderate to severe

pain on movement on day 3, whereas 81%

of the sample reported having experienced moderate to severe pain in the last 24 hours.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

PreoperativeEducationInterventionforSymptom ManagementAfterTKA

Table 3 Pain-Related Interference With Activity on Postoperative Day 3

Standard

Intervention Care

Interference (n= 70) (n= 65) Scores BPI-I M(SD) M(SD)

Total (scores 24.4 (14.4) 22.4(15:1)

0-60)?

Subscales (scores

0-10)

General activity 5.6 (3.2) 5.8 (3.2)

Walking 4.8 (3.0) 4.4 (3.5)

Mood 3.3 (3.2) DEANE)

Transfer from 4.8 (2.9) 5.0 (3.4)

bed to chair

Sleep 3.8 (3.5) 3:31(6"1)

Relationships 1-9(2:9) 1.6 (2.7)

with others

Note. BPI-I = Brief Pain Inventory, Interference. *t=— 0:76: p= .45.

NAUSEA

The impact of the intervention on nausea

was measured using the six-point ONI. There was no difference between groups in

nausea scores (previous 24 hours) over time

(F = 0.02; p = .88); however, there was a

difference within groups in nausea scores (previous 24 hours) over time (F = 50.9;

p < .01) with nausea decreasing over the 3-day period.

ANALGESIC AND ANTIEMETIC ADMINISTRATION

PCA-IV opioids prescribed for participants

postoperatively during the 3-day study

period were morphine (82%) and hydro-

morphone (18%). Oral opioids prescribed

on day 3 were morphine, hydromorphone,

or oxycodone (67%, 14%, and 18% of participants, respectively) and one par-

ticipant received oral codeine. Repeated-

measures analysis of variance demonstrated

Reprinted

with permission.

APPENDIXH #

Table 4 Pain on Postoperative Days 1, 2, and 3

Intervention Standard (n=62) Care (n=55)

NRS (0-10) M(SD) M(SD)

Pain right now

at rest?

Postoperative 4.1 (2.9) 3.7 (2.8)

day 1

Postoperative 3.3 (3.0) 2.9 (2.2)

day 2

Postoperative 2.8 (2.5) 2.8 (2.7)

day 3

Pain right now

when moving? Postoperative 6.4 (2.6) 6.4 (2.7)

day 1

Postoperative 6.2 (2.8) 5.9 (2.4)

day 2

Postoperative 5.4 (3.0) 6.1 (2.5)

day 3

Worst pain last

24 hours*

Postoperative VAD I2:5) 7.2 (2.8)

day 1

Postoperative 7.7 (2.4) Jebw(2eai)

day 2

Postoperative 7.0 (2.4) 7.0 (2.3)

day 3

Note. NRS = Numeric Rating Scale. 1 O65) = 3/0: >F = 1.61, p =.20. “F= 0.14, p= .87.

no difference between groups in daily

24-hour opioid administration, but for the total sample there was a significant main effect for time as analgesic administration in

both groups declined over the 3 postopera- tive days (F = 36.1; p = .000). For patients consistently reporting moderate to severe

pain on each day, opioid analgesic adminis-

tration also declined over their hospital stay (see Table 5). Overall, 7 participants did not receive any opioid analgesic doses on

postoperative day 3, two of whom did not

Reprinted

with permission.

Preoperative Education Intervention for Symptom Management After TKA 331

Table 5 Total Opioid Analgesic Administration for all Participants in Milligrams of Oral Morphine Equivalents for 24 Hours on Each of the 3-Day Trial Period

Intervention Standard (n=72) Care (n= 68)

Median Median

(Interquartile (Interquartile Range) Range)

Postoperative 78 (69) 78 (87)

day 1

Postoperative 62 (65) 56 (55)

day 2

Postoperative 40 (45) 40 (42)

day 3

receive any doses on postoperative day 2.

One participant did not receive any opioid

over the 3-day period. The routine dosing protocol ordered for all patients with TKA reporting even mild nau-

sea was three doses of a prescribed antiemetic (ondansetron). Overall, 79 (56%) participants

were administered at least one dose of anti- emetic over the 3-day trial period. However, for

those reporting moderate to severe nausea on

the first postoperative day, 29% in the interven-

tion group and 25% in the standard care group received no antiemetics in the previous 24-hour period. For those reporting either no or mild nausea in each group, 17% received at least one

dose of antiemetic during the same period.

= Discussion

There were no significant group differences in any of the outcomes in this trial. However,

the results of the total sample are important

to highlight. There were no differences in total or component scores for pain-related interference with activity as measured by the BPI-I Interference with general activity,

Generating and Assessing Evidence for Nursing Practice (11th ed.)

332 APPENDIXH

walking, and transfer from bed to chair were in the moderate to severe range and consistent

with results reported by Akyol, Karayurt, and Salmond (2009). A major emphasis of the

education content within all three components of intervention delivery was the importance of appropriately timed analgesic use to increase

opioid administration and improve pain and

pain-related interference with activity. In the

context of similar opioid use on postopera- tive day 3 in both groups—median daily oral

morphine equivalents: intervention 40 mg

(interquartile range = 45 mg), standard care 40 mg (interquartile range = 42 mg)—moder- ate to severe BPI-I scores in the intervention

group illustrate that placing the focus on the patient alone to ensure preactivity analgesia

administration is not sufficient to improve pain-related interference. Watt-Watson and colleagues (2004) reported that only 33% of prescribed analgesics were administered in

53% of patients reporting moderate to severe

pain in their study of 406 patients with car- diac surgery. These authors identified a lack

of understanding of opioid analgesia among health professionals, and recommended future

trials include focus groups with nursing staff

in particular to discuss issues affecting pain

management in the postoperative setting.

The education provided by all three com- ponents of the intervention that focused on

strategies to prevent resting pain and pain on

movement, including appropriate communica-

tion of pain to healthcare providers, failed to

produce a difference in pain ratings and qual- itative aspects of pain description. Moderate to severe pain, in the context of declining and

inadequate opioid analgesic administration,

is troubling and raises important questions about the postoperative environment in

terms of clinical care. Components of the intervention that reinforced analgesic use

before movement in an interval appropriate

to the type of analgesic administered were intended to maximize pain relief and improve

mobility to prevent further complications,

but the intervention focused on the patients and ignored the roles of the care providers. Additionally, data were not collected that

Generating and Assessing Evidence for Nursing Practice (11th ed.)

PreoperativeEducationInterventionfor Symptom ManagementAfterTKA

discriminated between surgical pain and other pain. Wittig-Wells, Shapiro, and Higgins

(2013) found that other or nonsurgical pain, present in 37% of their sample, interfered

with walking, mood, sleep, and relationships

with other people. Kearney et al. (2011)

reported a similar lack of effect on postoper- ative pain or activity in a trial of structured preoperative information in joint replacement

patients.

Opioid analgesic administration

(see Table 5) declined over the 3-day study

period (F = 36.1; p = .000), whereas pain

ratings on movement stayed in the moderate

range in both groups across all 3 postoper-

ative days. It is important to note that the median oral morphine equivalent adminis-

tration was 40 mg for patients in both trial

groups, only one third of the opioid doses that were prescribed. This finding is similar to the 33% of prescribed doses administered

in the study by Watt- Watson and colleagues (2004).

Unrelieved pain and stress response as

a result of acute, surgical injury can have

psychological and physiological consequences

for patients (Apkarian, Bushnell, Treede,

& Zubieta, 2005; Carr & Thomas, 1997;

Kehlet, 1997). The phenomenon of central sensitization of dorsal horn neurons by prolonged and repetitive nociceptive input

can create the physiology for a longer-term

pain problem (Bausbaum & Jessell, 2000)

predisposing patients to related comorbidities.

Patients with TKA with persistent, unrelieved pain are less likely to do specific physio- therapy activities (i.e., range of motion and

weight bearing) that may result in delayed rehabilitation and knee stiffness.

Concomitant moderate to severe nausea rates in this trial may reflect the established

interrelationship between pain and nausea. Twenty-eight percent of the intervention and

24% of the standard care groups reported experiencing moderate to severe nausea in

the previous 24 hours on postoperative day

3. The attenuation of the pain experience by the presence of nausea and the production of nausea by the pain experience (Fields, 1999;

Reprinted

with permission.

APPENDIXH #

Julius & Bausbaum, 2001; Kandel, Schwartz,

& Jessell, 2000) reinforces the need to address

both of these symptoms simultaneously.

This trial presents clear evidence that there are significant system issues influencing post- operative symptom management after TKA.

Participants in both groups who were report-

ing moderate to severe nausea or pain fre-

quently did not receive the antiemetic therapy or analgesics ordered. Evidenced-based proto- cols for nausea management were in place at

the trial site, but data show that they were not

followed consistently and in some cases, not

at all. Antiemetic agents used in these proto-

cols, ondansetron and prochlorperazine, are effective for postoperative nausea when given

appropriately (Dzwonczyk, Weaver, Puente,

& Bergese, 2012). In this trial, 25% of

participants who reported moderate to severe

nausea had no antiemetics administered at all. Similarly, participants who reported moderate to severe pain received approximately one

third of the prescribed doses of oral analgesic on postoperative day 3 despite hospital-wide

programs that support the need for effective

pain management (e.g., Pain, the Sth Vital

Sign). Other research has suggested that

this is not an unusual finding; nursing staff

education and attitude may be contributing factors. Gordon and colleagues (2008), ina

study of practice-associated pro re nata (PRN) administration of opioids in 602 registered nurses, found that comfort with dose titration

was directly and positively related to years of

practice experience.

At the trial site, the pain management

service is available for consultation by

the nursing staff at all times to modify or increase analgesic doses. Although patients

reporting scores in the moderate to severe range on pain assessment should, by insti-

tutional policy, be reviewed either by the attending service or the pain service, they were not. Although an inadequate explana- tion for deficiencies in care, staffing resources and patient acuity may have contributed to fewer pain and nausea assessments, placing

the onus on the patient to report symptoms

requiring treatment.

Reprinted

with permission.

Preoperative Education Intervention for Symptom Management After TKA 333

It appears that the current postoperative environment does not support best prac- tice for nursing staff in terms of symptom management regardless of the measures put in place. This finding is not unique to ortho-

paedic patient care. In a systematic review of

16 trials of labor support during childbirth in institutional settings, Hodnett, Gates,

Hofmeyr, and Sakala (2009) concluded that

the effectiveness of labor support interven- tions was mediated by the environment

in which the interventions were provided.

Although this clinical group has different

requirements than patients with TKA, findings of the review in terms of environmental fac- tors were similar. The ability of interventions

with patients to overcome barriers present

in the environment is limited if strategies to address these barriers are not also included.

Limitations of this trial are primarily

related to support for the implementation of

the educational material in the postoperative setting. As the intervention for this trial was directed only at the participants with no

component for staff education or protocol

development or monitoring, the influence of the healthcare environment on the ability of

the participants to engage in the associated behaviors was not reinforcing. Systems issues such as staff lack of adherence to established protocols for symptom management may have resulted in more pain and nausea and greater

functional interference. Institutional accountability reflecting

hospital accreditation standards in the clinical

environment for the provision of symptom

management and early identification and investigation of activity and mobility con-

cerns needs to be established. A consistent approach used by disciplines involved in the care of patients with TKA needs to span from

initial assessment for surgery to postopera-

tive care and includes all points of contact

between. In the preoperative setting, nursing

staff caring for orthopaedic patients must take the lead in ensuring surgical preparation,

which includes education that is reinforced

by all team members, regardless of their role.

Postoperatively, orthopaedic nursing staff

Generating and Assessing Evidence for Nursing Practice (11th ed.)

334 APPENDIXH ® PreoperativeEducationInterventionforSymptomManagementAfterTKA

must attend to the need for temporally appro-

priate symptom assessment and pharmaco- logic and nonpharmacologic interventions for patients. As this trial demonstrates that the

delivery of individualized educational content with reinforcement provided by booklet and telephone follow -followup was not suffi-

cient to impact postoperative symptoms after

TKA surgery, the nursing role as a symptom

management provider and patient advocate is

essential to the recovery after TKA. Further

trials that also include standardized informa- tion provided to patients by preadmission, surgical scheduling and postoperative nursing

and medical staff would be beneficial in supporting learned behaviors and knowledge uptake. Consistent with the recommenda-

tions of Watt-Watson and colleagues (2004),

a qualitative research approach using focus

groups of orthopaedic nursing, medical, and

physiotherapy staff could be undertaken to determine the environmental and patient- related characteristics, affecting the provision of analgesics and antiemetics and the relation- ship to postoperative activity.

CONCLUSION

The numbers of Canadians requiring primary

TKA has increased 140% over the last 10 years (CIHI, 2013). The highest rate of TKA

surgery is in the 75- to 84-year-age range

(65%). There are no published guidelines for

the preoperative preparation or postoperative

care of these relatively older aged patients. Inadequate management of symptoms such

as pain and nausea in the early postoperative period may result in increased morbidity for

patients and increased costs for the healthcare

system. The purpose of the trial was to exam-

ine the impact of individualizing preopera- tive patient education as a means to address

postoperative symptoms affecting recovery from TKA.

Providing information to patients alone

was not sufficient to address the need for postoperative symptom prevention and management after TKA. A broader, consistent

approach that includes healthcare providers

at all levels of patient contact is required to support recovery and rehabilitation after this type of surgery. Further research is required to delineate the barriers in the healthcare

environment to appropriate pain and nausea

management and to provide more evidence for the relationship between pain and nausea and functional outcomes for patients who

have had TKA.

Rosemary A. Wilson, RN(EC), PhD, Assistant

Professor, School of Nursing, Queen’s University,

Kingston, Ontario, Canada.

Judith Watt-Watson, RN, PhD, Professor Emeritus,

Lawrence S. Bloomberg Faculty of Nursing,

Senior Fellow, Massey College, University of

Toronto, Toronto, Ontario, Canada.

Ellen Hodnett, RN, PhD, Professor Emeritus,

Lawrence S.Bloomberg Faculty of Nursing,

University of Toronto, Toronto, Ontario,

Canada.

Joan Tranmer, RN, PhD, Professor, School of

Nursing, Queen’s University, Kingston, Ontario,

Canada.

This original research was partially funded by

an award from the Kingston General Hospital

Women’s Auxiliary Millennium Fund.

The authors declare that there are no conflicts of

interest.

DOI: 10.1097/NOR.0000000000000210

REFERENCES Akyol, O., Karayurt, O., & Salmomd, S. (2009).

Experiences of pain and satisfaction with pain man- agement in patients undergoing total knee replace- ment. Orthopedic Nursing, 28, 79-85.

Apkarian, A., Bushnell, M., Treede, R., & Zubieta, J.

(2005). Human brain mechanisms of pain percep- tion and regulation in health and disease. European Journal of Pain, 9(4), 463-484.

Bausbaum, A. I., & Jessell, T. M. (2000). The percep-

tion of pain. In Kandel, E., Schwartz, J., & Jessell, T., (Eds.), Principles of neural science (4th ed., pp. 472-491). New York : McGraw-Hill.

Beaupre, L. A., Lier, D., Davies, D. M., & Johnston,

D. B. C. (2004). The effect of a preoperative exercise and education program on functional recovery, health related quality of life, and health service utilization following primary total knee arthroplasty. Journal of Rheumatology, 31, 1166-1173.

APPENDIXH &

Benor, D.E., Delbar, V., & Krulik, T. (1998).

Measuring the impact of nursing interventions on cancer patients’ ability to control symptoms. Cancer Nursing, 21, 320-334.

Bondy, L. R., Sims, N., Schroeder, D. R., Offord, K. P.,

& Narr, B. J. (1999). The effect of anesthetic patient

education on preoperative patient’s anxiety. Regional Anesthesia and Pain Medicine, 24, 158-164.

Brander, V. A., Stulberg, S. D., Adams, A. D., Harden,

R.N., Bruehl, S., Stanos, S. P., & Houle, T. (2003).

Ranawat Award Paper: Predicting total knee replace- ment pain: A prospective, observational study. Clinical Orthopaedics and Related Research, 416, 27-36.

Canadian Institute for Health Information. (2014). Hip

and knee replacements in Canada 2012-2013 quick stats. Canadian Institute for Health Information. Retrieved from http://www.cihi.ca

Canadian Institute for Health Information. (2013). Hip

and knee replacements in Canada—Canadian Joint Replacement Registry 2013 Annual Report. Ottawa: CIHI ; 2013.

Carr, E., & Thomas, V. (1997). Anticipating and expe-

riencing post-operative pain: The patient’s perspec-

tive. Journal of Clinical Nursing, 6, 191-201. Chang, H. J., Mehta, P. S., Rosenberg, A., &

Scrimshaw, S. C. (2004). Concerns of patients

actively contemplating total knee replacement: Differences by race and gender. Arthritis and Rheumatism, 51(1), 117-123.

Cleeland, C., & Ryan, K. (1994). Pain assessment:

Global use of the Brief Pain Inventory. Annals of Academic Medicine Singapore, 23, 129-138.

Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale : Earlbaum

Associates.

De Wit, R., & Van Dam, F. (2001). From hospital

to home care: A randomized controlled trial of a Pain Education Programme for cancer patients with chronic pain. Journal of Advanced Nursing, 36(6), 742-754.

Dzwonczyk, R., Weaver, T., Puente, E., & Bergese,

S. (2012). Postoperative nausea and vomiting pro-

phylaxis from an economic point of view. American Journal of Therapeutics, 19(1), 11-15.

Fields, H. (1999). Pain: An unpleasant topic. Pain,

Supplement, 6, S61-S69. Gan, T. J., Meyer, T., Apfel, C. C., Chung, F., Davis,

P. J., Eubanks, S., ... Trameér, M. R. (2003).

Consensus guidelines for managing postoperative nausea and vomiting. Anesthesia & Analgesia,

97(1), 62-71.

Gordon, D., Pellino, T., Higgins, G., Pasero, C., &

Murphy- Ende, K. (2008). Nurses’ opinions of administration of PRN range opioid oral orders for acute pain. Pain Management Nursing, 9(3),

131-140. Hodnett, E., Gates, S., Hofmeyr, G.J., & Sakala, C.

(2009). Continuous support for women during child- birth. Cochrane Database of Systematic Reviews, 3,

CD003766.

Reprinted

with permission.

Preoperative Education Intervention for Symptom Management After TKA 335

Hodgkinson, B., Evans, D., & Wood, J. (2003).

Maintaining oral hydration status in older adults: A systematic review. International Journal of Nursing Practice, 9, $19-S28.

Johansson, K., Nuutila, L., Virtanen, H., Katajisto, J.,

& Salantera, S. (2005). Preoperative education for

orthopaedic patients: Systematic review. Journal of Advanced Nursing, 50, 212-223.

Johnson, J., Rice, V., Fuller, S., & Endress, P. (1978).

Sensory information, instruction in a coping strategy, and recovery from surgery. Research in Nursing and Health, 1(1), 4-17.

Jones, D., Westby, M., Griedanus, N., Johanson, N.,

Krebs, D., Robbins, L., Rooks, D., & Brander, V.

(2005). Update on hip and knee arthroplasty: Current

state of evidence. Arthritis and Rheumatism, 53(5), 772-780.

Julius, D., & Bausbaum, A. (2001). Molecular mecha-

nisms of nociception. Nature, 413, 203-210.

Kandel, E., Schwartz, J., & Jessell, T. (2000). The per-

ception of pain. Principles of neural science (4th ed., pp. 472-491). New York : McGraw-Hill.

Kearney, M., Jennrich, M. K., Lyons, S., Robinson,

R., & Berger, B. (2011). Effects of preoperative edu-

cation on patient outcomes after joint replacement

surgery. Orthopaedic Nursing, 30(6), 391-396

Kehlet, H. (1997). Multimodal approach to control

postoperative pathophysiology and rehabilitation.

British Journal of Anaesthesia, 78, 606-617. Larson, C. P. (1996). Evaluating the patient and preop-

erative preparation. In Barash, P. G., Cullen, B. F., &

Stoelting, R. K. (Eds.), Handbook of clinical anesthesia

(2nd ed., pp. 3-15). Philadelphia : Lippincott- Raven.

Lin, PaCe Linki @ry sc Linke jie 199 7,)eG@oniparing,

the effectiveness of different educational programs for patients with total knee arthroplasty. Orthopedic Nursing, 16, 43-49.

Louw, A., Diener, I., Butler, D. S., & Puentedura, E. J.

(2013). Preoperative education addressing post- operative pain in total joint arthroplasty: Review

of content and educational delivery methods. Physiotherapy Theory and Practice, 29(3), 175-194. doi:10.3109/0959 3985.2012.727527

McDonald, D. D., Freeland, M., Thomas, G., &

Moore, J. (2001). Testing a preoperative pain man- agement intervention for elders. Research in Nursing

and Health, 24, 402-409.

McDonald, D. D., & Molony, S. L. (2004). Postoperative

pain communication skills for older adults. Western Journal of Nursing Research, 26, 836-852.

McDonald, D., Thomas, G., Livingston, K., &

Severson, J. (2005). Assisting older adults

to communicate their postoperative pain. Clinical Nursing Research, 14(2), 109-126.

doi:10.1177/1054773804271934 McDonald, S., Page, M. J., Beringer, K., Wasiak, J., &

Sprowson, A. (2014). Pre-operative education for hip

and knee replacement (Review). Cochrane Database

of Systematic Reviews, 5, 10.1002/14651858.

CD003526. pub3.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

336 APPENDIXH #® PreoperativeEducationInterventionforSymptomManagementAfterTKA

Melzack, R. (1989). Measurement of Nausea. Journal

of Pain and Symptom Management, 4, 157-160.

Melzack, R. (1987). The short form McGill Pain

Questionnaire. Pain, 30, 191-197.

Melzack, R., Abbott, F., Zackon, W., Mulder, D., &

Davis, W. (1987). Pain on a surgical ward: a survey

of the duration and intensity of pain and the effec- tiveness of medication. Pain, 29, 67-72.

Melzack, R., & Wall, P. (1996). The challenge of pain

(2nd ed.). London : Penguin.

Mendoza, T. R., Chen, C., Brugger, A., Hubbard,

R., Snabes, M., & Palmer, S. N., ... Cleeland, C.

S. (2004a). The utility and validity of the modified

brief pain inventory in a multiple-dose postoperative analgesic trial. The Clinical Journal of Pain, 20(5),

357-362. % Mendoza, T. R., Chen, C., Brugger, A., Hubbard,

R., Snabes, M., & Palmer, S. N., ... Cleeland, C. S.

(2004b). Lessons learned from a multiple-dose post-

operative analgesic trial. Pain, 109(1), 103-109.

Parlow, J., Costache, I., Avery, N., & Turner, K.

(2004). Single-does haldoperidol for the prophy- laxis of postoperative nausea and vomiting after intrathecal morphine. Anesthesia and Analgesia, 98, 1072-1076.

Phillips, P. A., Johnston, C. L, & Gray, L. (1993).

Disturbed fluid and electrolyte homeostasis following dehydration in elderly people. Age and Aging, 22,

$26-S33. Roach, J. A., Tremblay, L. M., & Bowers, D. L.

(1995). A preoperative assessment and education program: implementation and outcomes. Patient

Education and Counseling, 25, 83-88. Salmon, P., Hall, G., Perrbhoy, D., Shenkin, A., &

Parker, C. (2001). Recovery from hip and knee arthroplasty: Patients’ perspective on pain, function, quality of life, and well-being up to 6 months post-operatively. Archives of Physical Medicine and Rehabilitation, 82, 360-366.

Sherwood, P., Given, B., Given, C., Champion, V.,

Doorenbos, A., Azzouz, F., ... Monahan, P. O.

(2005). A cognitive behavioural intervention for

symptom management in patients with advanced cancer. Oncology Nursing Forum, 32, 1190-1198.

Sjoling, M., Nordahl, G., Olofsson, N., & Asplund,

K. (2003). The impact of preoperative information on state anxiety, postoperative pain and satisfac-

tion with pain management. Patient Education and Counseling, 51, 169-176.

Stern, C., & Lockwood, C. (2005). Knowledge

retention from preoperative patient information.

International Journal of Evidence-Based Healthcare, 3, 45-63.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Strassels, S. A., Chen, C., & Carr, D. (2002).

Postoperative analgesia: Economics, resource use,

and patient satisfaction in an urban teaching hospital. Anesthesia and Analgesia, 94, 130-137.

Tan, G., Jensen, M. P., Thornby, J. L., & Shanti, B.

F. (2004). Validation of the Brief Pain Inventory for chronic nonmalignant pain. Journal of Pain, 5, 133-137.

Velji, K. (2006). Effect of an individualized symptom education program on the symptom distress of women receiving radiotherapy for gynecological cancer. Available from ProQuest database (AAT

NR21992). Wallis, J., & Taylor, F. (2011). Pre-operative inter-

ventions (non-surgical and non-pharmacological) for patients with hip or knee osteoarthritis awaiting joint replacement surgery—a systematic review and

meta-analysis. Osteoarthritis and Cartilage, 19(12), 1381-1395. doi:10.1016/j.joca.2011.09.001

Watt-Watson, J., Stevens, B., Katz, J., Costello, J.,

Reid, G., & David, T. (2004). Impact of pre-

operative education on pain outcomes after coronary artery bypass graft surgery. Pain, 109, 73-85.

Wilson, I. B., & Cleary, P. D. (1995). Linking clinical

variables with Health-Related Quality of Life: A conceptual model of patient outcomes. Journal of the American Medical Association, 273, 59-65.

Wilson, R., Goldstein, D., VanDenKerkhof, E., &

Rimmer, M. (2005). APMS clinical dataset. October

1, 2004, to October 1, 2005. Kingston, Ontario,

Unpublished. Wittig-Wells, D. R., Shapiro, S. E., & Higgins, M. K.

(2013). Patients’ experiences of pain in the 48 hours

following total knee Arthroplasty. Orthopaedic Nursing, 32(1), 39-44.

Wu, C., Naqibuddin, M., Rowlingson, A., Lietman, S.,

Jermyn, R., & Fleisher, L. (2003). The effect of pain

on health-related quality of life in the immediate postoperative period. Anesthesia and Analgesia, 97, 1078-1085.

Yates, P., Edwards, H., Nash, R., Aranda, S., Purdie,

D., & Najman, J., ... Walsh, A. (2004). A ran-

domized controlled trial of a nurse-administered educational intervention for improving cancer pain management in ambulatory settings. Patient educa- tion and counseling, 53(2), 227-237.

Zalon, M. L. (1997). Pain in frail, elderly women after

surgery. Image: Journal of Nursing Scholarship, 29 (1), 21-26.

Reprinted

with permission.

CRITICAL APPRAISAL OF WILSON ET AL. S StTuDY: “A RANDOMIZED CONTROLLED TRIAL OF AN INDIVIDUALIZED PREOPERATIVE EDUCATION INTERVENTION FOR SYMPTOM MANAGEMENT AFTER TOTAL KNEE ARTHROPLASTY”

= Overall Summary

This report was a well-written description of a strong quantitative study that used a rigorous randomized controlled design (RCT),

with appropriate randomization and blinding

procedures. The preoperative education

intervention for patients undergoing total

knee arthroplasty (TKA) was designed based

on earlier research and a broad conceptual

model. The authors provided useful infor-

mation about the intervention’s educational

components and a rationale for the content.

Although the intervention vs. control group

difference results were not statistically signif- icant, the findings were credible—that is, the results are unlikely to reflect problems with

inadequate statistical power or biases in the

design. The authors concluded that a patient

education approach to pain management

for patients undergoing TKA might not be effective in reducing adverse symptoms of the

surgery without changing the overall systems

of pain management in hospitals. Their con-

clusions could perhaps have been bolstered by the inclusion of a qualitative component to learn more about why patients in the

intervention group did not get more pain

medication than they in fact received.

# Title

The title of this report effectively communi- cated the nature of the study design (an RCT),

the nature of the intervention (individualized

preoperative education), the outcomes (symp- toms), and the population (patients undergo-

ing TKA).

& Abstract

The abstract for this paper was written as a traditional abstract, without subheadings.

The abstract was succinct, but conveyed

critical information about the study aim, the

nature of the intervention, the RCT study

design, and the sample size (N = 143). Key

outcomes were identified (pain interference,

pain, and nausea). The abstract also summa-

rized the findings, i.e., the absence of signif-

icant differences between the intervention

337

Generating and Assessing Evidence for Nursing Practice (11th ed.)

338 APPENDIXH ® PreoperativeEducationInterventionforSymptomManagementAfterTKA

and control groups on key outcomes. Finally, the authors provided a brief interpretation of their findings and suggestions for future research. The abstract provided information that readers would need in deciding whether to read the full report.

# Introduction

The introduction provided a sensible ratio- nale for this study. The authors explained the nature and scope of the problem (i.e., pain

and nausea as symptoms for patients under- going TKA, with many such procedures being

undertaken annually). They also noted that

several trials to address this problem through

educational interventions have been tested,

using a variety of delivery methods, and that

some had been found to result in lower pain scores. However, the results of these trials

were mixed, and no trials had addressed

issues relating to nausea following the TKA procedure.

The authors acknowledged that they were guided in the design of their intervention by

several systematic reviews. The researchers

also were guided by the positive results of individualized pre-operative interventions

tested with other patient groups (e.g., patients

with cancer). Based on earlier studies and

using a broad conceptual model (a conceptual map for which was provided in Figure 1),

the researchers developed a multi-component

intervention. The model itself does not appear

to have been the foundation for specific inter- vention components, however. For example,

the model did not purport to explain the

mechanisms through which the intervention

would lead to positive effects (e.g., by decreas- ing anxiety about potential addiction by using

opioids, by enhancing patients’ self-efficacy,

by improving patients’ communication skills).

The content for the intervention was derived from several earlier intervention projects; topics and supporting evidence

were nicely summarized in their Table 1.

The introduction concluded with a statement of the study purpose: “This study aimed to investigate the impact of an individually deliv- ered preoperative education intervention on

pain-related interference, pain, and nausea for

patients undergoing unilateral TKA.”

RESEARCH QUESTIONS

The researchers specified two questions. The primary question asked about the effect of the intervention on pain-related interference on postoperative day 3. The secondary question

asked about effects of the intervention on pain,

nausea, and analgesic and antiemetic adminis- tration on postoperative days 1, 2, and 3. The researchers did not formally state hypotheses, but it seems safe to infer that the researchers

predicted that the intervention would reduce pain, nausea, and pain interference.

The researchers did not test the effects of the intervention on possible mechanisms through which the intervention might have had positive effects. For example, if the researchers had expected lower pain levels among those in the intervention group because the educational

content was expected to decrease fears of addiction, they might have asked study partic-

ipants about such fears as an additional out- come. Several other factors might be expected to mediate the effect of the intervention on the outcomes, and questions about these mediators could have been addressed.

@ Methods

The method section was well organized into 5 2

several subsections.

TRIAL DESIGN

Wilson and colleagues used a strong two-group randomized controlled design to evaluate the effectiveness of the educa- tional intervention. Their Figure 2 nicely

Generating and Assessing Evidence for Nursing Practice (11th ed.)

APPENDIXH &

summarized schematically the progression

of activities and events in the trial, from

eligibility assessment to the measurement

of outcomes. The design was well-suited to testing the effects of an intervention and offered strong internal validity. Threats to internal validity (selection, attrition, etc.)

are implausible. The trial was conducted at a single academic health sciences center in Ontario, Canada, which could limit the gen-

eralizability of the results. Commendably, however, the researchers noted that the

study participants were similar to other

patients with TKA in terms of age, using

national (Canadian) TKA data, suggesting

broad demographic similarity of the sample to the target population.

STUDY PARTICIPANTS

The researchers clearly specified the inclusion and exclusion criteria for participation in the trial. Participants had to be scheduled for elec- tive TKA using planned intrathecal anesthet-

ics. They also had to be English speakers with telephone access and had to be planned for discharge to home. Patients who were booked for hemi, revision, or bilateral knee arthro-

plasty were excluded. The report provided adequate information about the recruitment and enrollment process. One issue, however,

is that the flow chart in Figure 3 does not

indicate the total number of patients who

were asked if their names could be passed

on to the research team. In other words, the

337 patients who were assessed for eligibility

does not include any patients who were recruited but declined to have their names

released to the research team. It would have

been helpful to understand how many patients opted out of the study initially.

INTERVENTIONS

Wilson and colleagues presented details about the three components of the intervention (a special booklet, an individualized teaching

Preoperative Education Intervention for Symptom Management After TKA 339

session, and a follow-up support telephone call). The researchers undertook a small, brief

pilot with 10 patients (not in the trial) 2 or 3 days after TKA surgery. The patients were

asked to review and comment on the interven- tion components. The researchers provided

information about who delivered the interven-

tion (the principal investigator in every case),

the procedures used to administer it, and the timing of the delivery of intervention compo- nents (within 4 weeks before surgery for the teaching session and review of the booklet, and during the week before the scheduled

surgery date for the telephone follow-up). The report did not describe the researchers’ ratio- nale for this schedule (e.g., why the follow-up was not within a day or two of the surgery).

Presumably the scheduling reflected practical considerations.

The report also presented information

about standard care, which is commendable.

Patients in both the intervention and control

group received an educational session by a physiotherapist, a 30-minute video explaining

the surgical procedure, and a brief review of using the intravenous patient-controlled anal-

gesia pump by clinic nursing staff. The timing of providing these supports was not indicated.

OUTCOMES

In a section labeled “Outcomes,” the

researchers described the instruments they

used to collect baseline and outcome data.

They used existing self-report scales to mea- sure pain, nausea, and pain interference. The

measure of pain interference was the Brief Pain Inventory, Interference (BPI-I), a scale

with items tapping the extent to which pain

interferes with specified functions: general activities, walking, mood, sleep, and relation-

ships with others. The researchers adapted the BPI-I slightly by deleting two items and

adding a new item (transferring from bed

to chair) to enhance the relevance of the

scale to patients in the study, thus creating

a 6-item scale. The researchers noted that the original measure has well-established

Generating and Assessing Evidence for Nursing Practice (11th ed.)

340 APPENDIXH ® PreoperativeEducationinterventionforSymptom ManagementAfterTKA

construct validity and sensitivity to change.

The researchers did a small pilot test of the adapted scale with 14 patients, but they did not assess any psychometric properties. They

did note that a similarly adapted scale had an

internal consistency reliability of .71, which is modest. However, moderate internal consis-

tency is typical in brief scales such as this one. The researchers stated that secondary out-

comes were measured using the Short Form

McGill Pain Questionnaire (MPQ-SF) and the

Overall Nausea Index. No information was

provided about the reliability and validity of these scales. Data about antiemetic and opioid

administration were recorded from hospital

charts. Information about the study outcomes was

in some cases confusing. For example, the

authors did not provide readers with infor- mation about how the BPI-I scale was scored.

That is, readers cannot be sure if higher scores

on the BPI-I are associated with greater or

lesser degrees of interference from pain. By consulting the papers cited by the researchers,

we learned that each of the six BPI-I items is scored from 0 (“pain does not interfere”) to 10 (“pain interferes completely). This

information is needed to interpret the results shown in Table 3.

Some information about measures used in

the study was included in the section labeled

“Statistical Analysis.” The researchers referred

for the first time to using Numeric Rating Scale questions from the MPQ-SF, without elaborat-

ing the nature of those questions (and, in fact, the results for the MPQ-SF are shown in Table 4 with no mention of the scale name). The sta-

tistical analysis section also refers to a measure

of the frequency of postoperative activities completed (the TKA-AQ) with no further men-

tion in terms of its properties or results.

SAMPLE SIZE

The researchers did a power analysis to estimate the sample size they would need in this study. They based their estimate of

the effect size (d = .5) on a previous study by one of the team members. The power analysis indicated that a sample of 64 patients in each group would be required, but they built in‘a cushion of 10% for

attrition. Thus, the researchers sought a

sample size of 140 patients. Laudably, the researchers further justified their effect

size estimate by noting that a d of .50 would be a clinically significant amount

of improvement.

RANDOMIZATION AND BLINDING

The researchers used an excellent randomiza- tion method—they relied on a randomization

service not connected to the trial. Such a

service is preferred to randomization by team members because it minimizes the risk of bias. Although neither the patients nor the person

delivering the intervention could be blinded

because of the nature of the intervention, the

research assistants who collected the postop- erative outcome data were blinded to group assignment.

STATISTICAL ANALYSIS

The researchers provided a good descrip-

tion of the statistical tests and the statistical

software they used. For the primary question relating to pain interference, which was mea- sured only once on post-operative Day 3, they

used an independent groups.t-test to compare

the two study groups. For the secondary ques-

tions relating to pain and nausea, a repeated

measures analysis of covariance was used,

which was appropriate because these out-

comes were measured three times. The analy-

ses permitted the researchers to compare the two groups at each time points, and to look at changes over time for both groups. Finally, for the data on administration of analgesics and antiemetic medication, chi-squared tests were used to compare the intervention and control groups.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

APRENDIXH &

= Results

The results section began with a description of the study sample. A useful flow chart was included that showed how many patients were screened for eligibility (N = 337), how

many were excluded for various reasons

(N = 194), how many were randomized

(N = 143), and how many actually received

the treatment to which they were assigned. A

total of 140 were measured for postoperative outcomes, which is the number the power

analysis suggested the researchers needed. Background characteristics of the sample

were presented in Table 2, which showed that the two groups were similar in terms of sex,

education, use of pain medication, and their

preoperative diagnosis.

PRIMARY RESEARCH QUESTION

The researchers reported that group differ-

ences on the pain interference measure (the

BPI-I scale), were not statistically significant

(p = .45). The mean score for those in the

intervention group was modestly (but not

significantly) higher than the mean score

for the control group. Table 3 also showed mean scores for the 6 individual item scores on the BPI-I (walking, sleep, mood, etc.);

group differences were not significant for any

of them. We can see, however, that across

both groups, pain interference was lowest for “Relationships with others” and highest for

“General activity.”

SECONDARY RESEARCH QUESTION

With regard to pain, the researchers stated that there were no group differences in levels of pain on any of the postoperative days. One confusing aspect of the report is that the authors stated in their section labeled “Outcomes” that pain and pain quality were

measured using the Short Form McGill Pain

Preoperative Education Intervention for Symptom Management After TKA 341

Questionnaire (MPQ-SF). In the Results

section, the authors mentioned a measure

not previously described, the Present Pain Intensity (PPI) global pain rating. They also refer to other measures using acronyms with- out any explanation (PRI-S, PRI-A, and PRI-

T). Presumably these are components of the

MPQ-SF, but more information should have

been presented in the Methods section. Also, as previously noted, Table 4, which summa-

rizes some of the results for pain outcomes, refers to “Numeric Rating Scales” (NRS)

without indicating that these are components of the MPQ-SF. In any event, for several

of these measures the researchers reported

significantly declines in pain scores over time, but not significant differences between the intervention and the control groups.

With regard to nausea, the researchers reported that differences between the inter- vention and control group on the measure

of nausea was not significant (p = .88). In both groups, nausea declined over the 3-day period.

Similarly, there were no significant differ- ences between the intervention and control

groups regarding daily opioid administra-

tion, but there were significant declines over time in both groups. The Results

section also presented interesting descriptive information about the use of medications in this sample. For example, the researchers

reported that 7 participants received no opioid analgesic doses on Day 3, and that

only 56% of patients were administered at least one dose of antiemetic over the 3-day

period. One further issue is that the researchers

appeared not to have undertaken any sub- group analyses—that is, analyses designed to

assess whether their intervention was effec- tive for patients with certain characteristics. In the “Conclusion” section, the researchers

made a special note of preoperative prepara- tions for older patients in the 75+ age range. Perhaps intervention effects for age-based

subgroups are worthy of exploration in this

dataset.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

342 APPENDIXH ® PreoperativeEducationInterventionforSymptomManagementAfterTKA

# Discussion

The researchers concluded that their interven-

tion was not effective in reducing pain, nausea, and pain interference in patients undergoing

TKA. With nonsignificant results, it is some-

times risky to draw such conclusions because

of the possibility of a Type II error, but the authors’ conclusions seem appropriate because

they used a powerful RCT design, their analy-

sis appeared to have adequate power, and the

results were consistent across all outcomes. The researchers’ main conclusion was

that patient education was ineffective because the problem of appropriately

timed and appropriately dosed medica-

tion reflected a systems-wide problem.

They noted that the trial presented “clear evidence that there are significant systems issues influencing postoperative symptom

management after TKA.” They pointed out

that the patients often did not receive the

medications that had been ordered, that

evidence-based protocols for nausea man- agement were not followed, and that the

pain service in the hospital did not review

cases with high levels of pain, as mandated

by institutional policy.

Although these conclusions are very likely to be legitimate, the researchers do

not appear to have considered alternative or

supplementary explanations for the disap-

pointing results, such as deficiencies with the intervention itself, or barriers to symp-

tom management stemming from the patient

population (in addition to system barriers).

For example, it is possible that patients did not ask for (or declined accepting) opioids because when they received them on the first

postoperative day they experienced negative side effects such as unwanted drowsiness/

lethargy, impaired cognition, and increased

nausea. It likely would have been useful if this study had been designed as a mixed methods project—that is, if patients had

been asked to provide in-depth information about their symptom experiences, their

requests for medication, their reluctance to request analgesics, or their refusal of opi- oids offered to them. The researchers did,

however, suggest that a future trial should include a qualitative component targeting

orthopedic nursing, medical, and physio-

therapy staff. The study might also have

benefited by including measures of some proximal outcomes of the intervention—

such as patients’ knowledge of and attitudes toward pain management strategies.

The researchers noted in their discussion that a limitation of this study was that staff education should have been included as a

supplementary component. However, this

would not have been feasible with the existing research design, because staff education would

have benefited members of both the interven- tion and the control group. To test whether a

combined patient-staff education effort would result in better symptom management, the trial

would have to be conducted in multiple sites,

with sites randomly assigned to either receive or not receive the multi-prong intervention

(i.e., a cluster randomized design).

One final comment is that the research- ers did not discuss their findings within the

context of earlier research. Prior interven-

tion trials, such as studies by McDonald,

were described in the introduction as having

positive impacts on pain. The authors did

not speculate on why their results might be at odds with those of previous studies that helped to guide this research.

= Other Comments

PRESENTATION a

This report was clearly written and well orga-

nized. Except for a few areas of confusion regarding pain outcomes, the report provided

excellent information about what was done,

why it was done, and what was discovered.

The report included several excellent figures and tables.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

APPENDIXH #8

ETHICAL ASPECTS

The authors stated that ethical approval for this study was obtained from the Research Ethics Board of both the university where the researchers worked and the hospital where the data were collected. Potential participants

Preoperative Education Intervention for Symptom Management After TKA 343

were asked for their permission by hospital staff to release their names to the investigator, using a standardized script. Written informed consent was obtained before randomization. Nothing in the description of this study sug- gests ethical transgressions.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

WHVi ive

gph i

DIFFERENCES IN PERCEPTIONS

OF THE DIAGNOSIS AND TREATMENT OF OBSTRUCTIVE SLEEP APNEA AND CONTINUOUS PosiTivE AIRWAY PRESSURE THERAPY AMONG ADHERERS AND

NONADHERERS Amy M. Sawyer e JanetA.Deatrick * Samuel T. Kuna e Terri E. Weaver

> Abstract: Obstructive sleep apnea (OSA) patients’

consistent use of continuous positive airway pressure

(CPAP) therapy is critical to realizing improved

functional outcomes and reducing untoward health

risks associated with OSA. We conducted a mixed

methods, concurrent, nested study to explore OSA

patients’ beliefs and perceptions of the diagnosis

and CPAP treatment that differentiate adherent from

nonadherent patients prior to and after the first week

of treatment, when the pattern of CPAP use is estab-

lished. Guided by social cognitive theory, themes were

derived from 30 interviews conducted postdiagnosis

and after 1 week of CPAP use. Directed content

analysis, followed by categorization of participants

as adherent/nonadherent from objectively measured

CPAP use, preceded across-case analysis among 15

participants with severe OSA. Beliefs and perceptions

that differed between adherers and nonadherers

included OSA risk perception, symptom recognition,

self-efficacy, outcome expectations, treatment goals,

and treatment facilitators/barriers. Our findings sug-

gest opportunities for developing and testing tailored

interventions to promote CPAP use.

> Key Words: adherence - compliance - content

analysis - decision making - health behavior - mixed

methods - sleep disorders - social cognitive theory

Obstructive sleep apnea (OSA), characterized

by repetitive nocturnal upper airway collapse

resulting in intermittent oxyhemoglobin desat- uration and sleep fragmentation, contributes

to significant disabling sequelae, including

daytime sleepiness, impaired cognitive and

executive function, mood disturbances, and

increased cardiovascular and metabolic morbidity (Al Lawati, Patel, & Ayas, 2009;

Harsch et al., 2004; Niefo, et al., 2000;

Peppard, Young, Palta, & Skatrud, 2000). The prevalence of OSA, based on minimal

diagnostic criteria (apnea/hypopnea index

[AHI] of 5 events/hour), has been estimated at

2% in women and 4% in men in the United

States (Young et al., 1993). More recently,

large U.S.-cohort studies have provided

344 Reprinted with permission from Sawyer, A. M., Deatrick, J. A., Kuna, S. T., and Weaver, T. E. (2010). Differences in perceptions of the diagnosis and treatment of obstructive sleep apnea and continuous positive airway pressure therapy

among adherers and nonadherers. Qualitative Health Research, 20(7), 873-892.

a APPENDIX!

additional evidence of the prevalence of OSA, estimating that approximately one in five

adults with a mean body mass index (BMI) of

at least 25 kg/m* has at least mild OSA, defined as an apnea-hypopnea index (AHI) > 5 events/

hour; and one in 15 adults with a mean BMI

of at least 25 kg/m? has at least moderate OSA (1.e., AHI = 15 events/hour; Young, Peppard,

& Gottlieb, 2002). Continuous positive airway pressure (CPAP) therapy is the primary medi- cal treatment for adults with OSA, eliminating repetitive, nocturnal airway closures; normal- izing oxygen levels; and effectively improving daytime impairments (Gay, Weaver, Loube,

& Iber, 2006; Sullivan, Barthon-Jones, Issa, &

Eves, 1981; Weaver & Grunstein, 2008).

Nonadherence to CPAP is recognized as a significant limitation in the effective treatment of OSA, with average adherence

rates ranging from 30% to 60% (Engleman,

Martin, & Douglas, 1994; Kribbs et al.,

1993; Krieger, 1992; Reeves-Hoche, Meck,

& Zwillich, 1994; Sanders, Gruendl, &

Rogers, 1986; Weaver, Kribbs, et al.,

1997). Nonadherent users begin skipping nights of CPAP use during the first week of treatment, and their hourly use of CPAP

on days used is significantly shorter than those who apply CPAP consistently (Aloia, Arnedt, Stanchina, & Millman, 2007;

Weaver, Kribbs, et al., 1997). Patients who

are nonadherent during early treatment

generally remain nonadherent over the long term (Aloia, Arnedt, Stanchina, et al.,

2007; Krieger, 1992; McArdle et al., 1999;

Weaver, Kribbs, et al., 1997). The return of

symptoms and other manifestations of OSA with even one night of nonuse underscores

the critical nature of adherence to CPAP

(Grunstein et al., 1996; Kribbs et al., 1993).

Many studies have explored what factors predict adherence to CPAP (Engleman et al., 1996; Engleman, Martin, et al., 1994;

Kribbs et al., 1993; Massie, Hart, Peralez,

& Richards, 1999; McArdle et al., 1999;

Meurice et al., 1994; Reeves-Hoche et al.,

1994; Rosenthal et al., 2000; Schweitzer,

Chambers, Birkenmeier, & Walsh, 1997; Sin,

Mayers, Man, & Pawluk, 2002). Self-reported

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 345

side effects of CPAP do not distinguish between adherers and nonadherers to CPAP. Subjective sleepiness, severity of OSA as deter-

mined by apnea-hypopnea index, and severity of nocturnal hypoxia are inconsistently

identified as correlates, albeit weak, of CPAP

adherence (Weaver & Grunstein, 2008). The

majority of these studies have focused on physiological variables and patient character-

istics as predictors of adherence. Over the past 10 years, studies have identified psychological and social factors and cognitive perceptions, such as self-efficacy, risk perception, and out-

come expectancies, as determinants of CPAP

use (Aloia, Arnedt, Stepnowsky, Hecht, &

Borrelli, 2005; Lewis, Seale, Bartle, Watkins,

& Ebden, 2004; Russo-Magno, O’Brien,

Panciera, & Rounds, 2001; Stepnowsky,

Bardwell, Moore, Ancoli-Israel, & Dimsdale,

2002; Stepnowsky, Marler, & Ancoli-Israel, 2002; Wild, Engleman, Douglas, & Espie,

2004). Social and situational variables

have also been suggested as influential on

CPAP adherence, with those who live alone,

who have had a recent life event, and who

experienced problems with CPAP on the first night of exposure having lower adherence to CPAP therapy (Lewis et al., 2004). Support group attendance has also been identified as contributing to higher CPAP use in older men

(Russo-Magno et al., 2001). Findings of both

of these studies suggest that social support is an important factor influencing decisions to

use CPAP, yet the sociostructural context of

accepting and adhering to CPAP treatment

has not been described from the perspective of the patient in the extant literature. Other

studies have identified that early experiences with CPAP (i.e., during the first week) are an important influence on patients’ percep-

tions and beliefs about the OSA diagnosis and treatment with CPAP (Aloia, Arnedt,

Stepnowsky, et al., 2005; Stepnowsky,

Bardwell, et al., 2002). From the collective published evidence,

early experiences with CPAP, combined with patients’ perceptions and beliefs about OSA and

CPAP and the balance of their sociostructural

facilitators/barriers, are critical factors that

Generating and Assessing Evidence for Nursing Practice (11th ed.)

| ed

b) iy

346 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

influence patients’ decisions to use CPAP. To

date, there are relatively few studies that have

systematically examined the influence of disease

and treatment perceptions and beliefs on CPAP adherence. Because the first week of CPAP treat- ment is critically influential on OSA patients’ decisions to use CPAP, it is imperative that the

contextual experiences and underlying beliefs

and perceptions of the diagnosis and treatment

be described. There are no published studies

that have addressed this significant gap in the

scientific literature. Furthermore, no study has

directly explored patient perspectives, employ-

ing qualitative methodology, both at diagnosis and with treatment, to more fully describe con-

textual factors that differentiate CPAP adherers and nonadherers. Our study addressed several

important questions: (a) What are adult OSA

patients’ beliefs and perceptions about OSA, the associated risks, and treatment with CPAP prior

to treatment use? (b) What are the consequences

of these beliefs and perceptions on the use of CPAP? (c) What are the beliefs and perceptions of adults with OSA after 1 week of CPAP use,

including perceived benefits of treatment, effect of treatment on health, and perceived ability

to adapt to CPAP? and (d) Do differences exist

between adherers and nonadherers with regard to their beliefs and perceptions at diagnosis and with treatment use that might, in part, explain

differences in CPAP adherence outcomes? To

our knowledge, our study findings provide the

first published description of beliefs of those

who adhere and those who choose not to

adhere to CPAP treatment. These findings con- tribute to understanding patient treatment decisions regarding CPAP use, suggest oppor-

tunities for identifying those at risk for non-

adherence to CPAP, and contribute toward

developing tailored interventions to promote CPAP use.

#@ Conceptual Framework

Acceptance and consistent use of CPAP is

influenced by a multitude of factors, as is evidenced in previous studies examining

predictors of CPAP adherence (Weaver &

Grunstein, 2008). It is therefore important to

approach the phenomenon of CPAP adherence from a multifactorial perspective that addresses

the complex nature of this particular health behavior. The application of social cognitive

theory has been widely applied in studies of adoption, initiation, and maintenance of health behaviors (Bandura, 1977, 1992; Schwarzer

& Fuchs, 1996). The core determinants of

the model include knowledge, perceived self- efficacy, outcome expectations, health goals, and facilitators/barriers. The model posits that health-promoting behaviors are primarily influenced by patients’ self-efficacy, or their

belief in their ability to exercise control over

personal health habits, which influences other critical determinants: knowledge, outcome

expectations, goals, and perceived facilita-

tors and impediments (Bandura, 2004; see

Figure 1). Knowledge of health risks and specific benefits relative to health behaviors is a necessary determinant for health behaviors,

but rarely does knowledge alone promote

change in behaviors. Outcome expectations, or the expectancies one holds for investing in a particular health behavior, are evaluated by the individual in terms of costs and benefits,

including physical, social, and psychological. Individuals who anticipate that the benefits of a health behavior outweigh the costs are more

inclined to perceive the health behavior as

favorable, and more inclined to set short- and

long-term personal goals to guide adoption of that health behavior. This cascade of health behavior determinants does not occur in isola-

tion, but is influenced by barriers and facili-

tators that derive from personal, social, and environmental circumstances. As individuals identify facilitators for the health behavior and

overcome barriers, their belief in their ability to

successfully change or adopt a health behavior

(1.e., perceived self-efficacy) increases.

Recognizing that individuals exist within a collective agency or community, the construct

of self-efficacy is not confined solely to per-

sonal capabilities. Although commonalities in

the basic concepts of self-efficacy exist across

cultures, the “cultivated identities, values, belief

ie APPENDIX!

Self-Efficacy |

Outcome Expectations

Sociostructural Factors

Facilitators/Impediments

Diagnosis and Treatment of OSA and CPAP Therapy 347

Behavior

Figure 1. Social cognitive theory health determinants: Pathways of influence of self-efficacy on health

behaviors. From Bandura, A. (2004). Health promotion by social cognitive means. Health Education &

structures, and agentic capabilities are the psychosocial systems through which experiences

are filtered” (Bandura, 2002, p. 273). Bandura

suggested that the application of social cognitive theory must be situated in context, recognizing

that “human behavior is socially situated, richly contextualised, and conditionally expressed” (2002, p. 276). From this conceptual perspective

and in a predominantly qualitative research paradigm, we examined patients’ perceptions,

beliefs, and experiences within their own con- text to permit an explicit description of salient

factors that influenced OSA patients’ decisions to use or not use CPAP.

@ Method

DESIGN

Using a concurrent nested, mixed method

design, we conducted a longitudinal study extending from initial diagnosis through the first week of home CPAP treatment of newly diagnosed OSA patients. We conducted two

individual interviews with participants and

collected firstweek CPAP adherence data. In contrast to a triangulation design, the con-

current nested study design emphasizes one

methodology, and the data are mixed at the analysis phase of the study (Creswell, Plano

Clark, Gutmann, & Hanson, 2003). Nesting

the less dominant quantitative method within the predominant qualitative method permitted

Reprinted

with permission.

an enriched description of the participants and a more in-depth analysis of the overall

phenomenon of interest: CPAP adherence (Creswell et al., 2003).

PARTICIPANTS

Adults with suspected OSA were recruited from a sleep clinic at an urban Veterans Affairs

medical center during a 5-month enrollment period. One sleep specialist referred potential participants who were clinically likely

to have OSA to the study. Our purposive sampling strategy was to include patients

who (a) provided detailed information during

their initial clinical visit and were willing to openly discuss their health and health care; (b)

had at least moderate OSA (AHI > 15 events/

hour; American Academy of Sleep Medicine Task Force, 1999) and were prescribed CPAP

treatment; (c) initially accepted CPAP for home

use; and (d) were able to speak and under-

stand English. To ensure that participants would be prescribed CPAP treatment based on Veterans Health Administration CPAP prescribing guidelines in place during study enrollment, patients with mild OSA (AHI < 15

events/hour) were excluded. We also excluded

participants who had current or historical treatment with CPAP or any other treatment

for OSA, a previous diagnosis of OSA, refusal of CPAP treatment by the participant prior to

any CPAP exposure (i.e., in-laboratory CPAP

titration sleep study), and those who required

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

| ee lied

348 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

supplemental oxygen in addition to CPAP and/

or bilevel positive airway pressure therapy for treatment of sleep-disordered breathing during their in-laboratory CPAP titration sleep study.

Previous studies have identified that deci- sions to adhere to CPAP emerge by the second

to fourth day of treatment (Aloia, Arnedt,

Stanchina, et al., 2007; Weaver, Kribbs, et al.,

1997). Therefore, it is possible that patients’ beliefs, perceptions, and experiences during

the first several experiences with CPAP might

significantly influence short- and long-term CPAP adherence patterns. For this reason, we

did not include individuals who refused CPAP treatment prior to any CPAP experience,

because we sought to describe salient factors

preceding and during initial CPAP exposure. The protocol was approved by the research

site and the affiliated university’s institutional

review boards. All participants provided informed consent prior to participating in any

study activities.

PROCEDURE

After study enrollment, each participant had

two in-laboratory, full-night sleep studies

(i.e., polysomnograms). The first sleep study

was a diagnostic study and the second sleep

study was to determine the therapeutic CPAP

pressure necessary to eliminate obstructive sleep apnea events. All sleep studies were performed

and scored using standard criteria (American

Academy of Sleep Medicine Task Force, 1999;

Rechtschaffen & Kales, 1968). The AHI, a

measure of disease severity in OSA, was com-

puted from the diagnostic polysomnogram as

the number of apneas and/or hypopneas per

hour of sleep. The therapeutic CPAP pressure, the pressure required to eliminate hypopneas and apneas, was determined on a manual CPAP

titration polysomnogram performed about 1 week (7.9+6.9 days) after the diagnostic polysomnogram.

Semistructured Interviews. Semistructured interviews, conducted by one study investigator, were scheduled with participants

Generating and Assessing Evidence for Nursing Practice (11th ed.)

at two intervals: within 1 week following diagnosis but prior to the CPAP titration

sleep study, and after the first week of CPAP treatment at home (see Figure 2). All interviews were conducted in an informal,

private room at the medical center to ensure

Initial Clinical Evaluation at

Sleep Center & Recruitment (n= 19)

Informed Consent &

Enrollment (n = 18)

Demographic Survey

Standardized OSA and

CPAP Education:

20-minute video & brochure

Diagnostic Sleep Study (n = 16)

Failure to attend sleep study

excluded

Interview 1

Postdiagnosis (n = 16)

CPAP Sleep Study .

(n= 16)

Interview 2

Post-CPAP Treatment (n= 16)

CPAP Adherence Data

Collection (n = 15)

Refused CPAP treatment excluded

Figure 2. Study design

Reprinted

with permission.

APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy 349

privacy, participant comfort, and promote

open sharing of information (Streubert Speziale & Carpenter, 2003). To minimize

attrition, participants were offered the opportunity to participate in interviews at

an alternative location or by telephone if transportation difficulties or ambulatory limitations precluded study participation.

Interview guides, consisting of specific

questions and probes (i.e., prompts to

encourage focus on the particular issue

of interest) were used for each interview

to ensure that a consistent sequence and

set of questions were addressed across participants. A funnel approach was used

in the development and execution of the

interview guides. This approach begins with broad questions and gradually pro- gresses to focused questions specific to

Table 1 Postdiagnosis Interview Guide

the phenomenon of interest to promote

sharing of experiences by the participants (Tashakkori & Teddlie, 1989). The first

interview focused on perceptions of the

diagnosis, perceived health effects of the diagnosis, pretreatment perceptions of

CPAP, and the social and cultural precedents that led to the participant seeking medical

care for their sleep problems (see Table 1). The second interview focused on perceived effects of treatment with CPAP, support- ive mechanisms or barriers to using CPAP,

and how beliefs and perceptions about the diagnosis, associated risks of the diagnosis,

and the treatment experience might have

affected CPAP adherence (see Table 2).

Interviews were digitally audio-recorded and transcribed to an electronic format by

a professional transcriptionist not affiliated

Concept Topic/Question

Perceptions and knowledge of | How did you know about sleep disorders and the sleep

diagnosis center before coming to your first appointment?

Before being told you have OSA,’ had you heard of OSA? If

so, what did you know about OSA?

What do you now understand about OSA?

After having your sleep study, what are your thoughts

about OSA and what it means to you?

Perceived effects of diagnosis | How do you believe OSA affects you in your daily life?

Sociocultural precedents and Do you know anyone else who has been diagnosed with

influences on health, illness/

disease, and care seeking

OSA? If so, how did that impact you and your interest in

coming to the sleep center?

Why did you seek care from the sleep center?

Is there anyone who influenced you to seek care for this

problem?

Is there anyone who has helped you understand what OSA

is? If so, how did that information impact your desire to

receive treatment?

What has you experience with a health care system been to

this point?

Do sleep, sleeping, and/or the sleep environment have

any specific meaning(s) to you? To your family? To your

spouse/significant other/bed partner?

°OSA = Obstructive sleep apnea

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

bw WT tee

») 4

350 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

Table 2 One Week Post-CPAP Use Interview Guide

Concept Topic/Question

Perceived effects and knowledge of Have you been using CPAP? for the treatment of

treatment with CPAP your OSA°? How would you describe your use of CPAP?

Are you experiencing any improvement in the way

that you feel since you have started using CPAP?

When did you first learn about CPAP?

Who first described CPAP to you?

What did you think when you first learned about

. CPAP? First saw CPAP? First used CPAP in the

sleep laboratory?

What do you see as the most important reason for

using CPAP in the short term? In the long term?

Supportive mechanisms or barriers How was the first week of CPAP treatment?

to incorporating CPAP into daily life

What kinds of problems are you experiencing using

CPAP?

What has prevented you from regularly using

CPAP?

What has been helpful to you in regularly using

CPAP?

Sociocultural perspectives of health- Do you believe CPAP treatment is a treatment you

related decisions to use or not use can [continue to] use?

CPAP

Did this belief change since you first learned about

your OSA diagnosis? Since starting CPAP?

Do you envision yourself using CPAP during the

next 3 months? During the next year? During the

next 5 years?

Do you have any concerns about the CPAP unit?

About your sleep [ability or quality]? About your

sleep environment that might affect your CPAP use?

How does the diagnosis of OSA and treatment with

CPAP affect or been affected by those around you?

“CPAP = continuous positive airway pressure

SOSA = obstructive sleep apnea

with the study. Field notes were maintained descriptive context of the interview, but also by the interviewer before and after each served as interviewer reflexivity notations interview to describe the environment of (i.e., interviewer biases, suppositions, and the interview, describe the participant at the presuppositions of the research topic). The time of the interview, and note any aberra- purpose of maintaining reflexivity notations tions from the planned interview guide that was to ensure that interviewer-imposed occurred and a description of such aberra- assumptions did not take precedent over the tions. The field notes not only served as a participant’s described experience.

Se APPENDIX!

CPAP Adherence. In accordance with the

standard of clinical care at the sleep center, all participants were issued the same model CPAP machine (Respironics RemStar Pro®)

that records on a data card (SmartCardTM)

the time each day that the CPAP circuit is pressurized, an objective measurement of

daily CPAP mask-on time. CPAP use was defined as periods when the device was applied for more than 20 minutes at effective pressure. One week of CPAP adherence data

were uploaded to a personal computer for software analysis (Respironics EncorePro®) at the time of the second semistructured

interview. Graphic adherence data were used

as probes to discuss specific occurrences of CPAP nonuse. The objectively measured CPAP adherence data were also used to identify adherent (> 6 hrs/night CPAP use)

and nonadherent participants (< 6 hrs/night CPAP use). A cut-off point of 6 hours/night

was selected a priori to describe adherers and nonadherers to CPAP treatment, as recent

evidence suggests that 6 or more hours of

CPAP use per night is necessary to improve

both functional and objective sleepiness

outcomes (Weaver et al., 2007).

ANALYSIS

A sequential analysis was conducted, with qualitative-directed content analysis of interview

data followed by quantitative descriptive analy- sis of the CPAP adherence data. By sequentially

analyzing the data, the priority of the individual as informant was emphasized and the investiga-

tors were blinded to CPAP adherence until the

final analysis procedure, a mixed methods anal-

ysis, was conducted (see Figure 3). By dividing

the participants into categories of adherent (i.e., > 6 hrs/night CPAP use) and nonadherent (i.e.,

< 6 hrs/night CPAP use), we examined across-

case consistencies in subthemes and themes to

describe the contextualized experience of adher-

ing or not adhering to CPAP treatment. Each transcript was read in its entirety,

highlighting, extracting, and condensing text

from individual interviews that addressed

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 351

individual beliefs, perceptions, and/or expe- riences during diagnosis and early treatment with CPAP. This process of text analysis brought forward the manifest content of the qualitative data (Graneheim & Lundman, 2004). These responses were separated from the interview text, identified by participant identification number, and entered into an

analysis table. Abstraction, or the process of taking condensed, manifest data and inter- preting the underlying meaning (i.e., latent meaning), followed as participant responses were then described in a condensed format and interpreted for meaning within a the- matic coding process. Trustworthiness was enhanced as the likelihood of investigator bias was minimized by first highlighting relevant text for coding, extracting relevant text from complete interviews transcripts, and then

coding the meaning units for theory-driven categories or themes and then for subthemes (Hsieh & Shannon, 2005).

The overarching, theory-derived themes were initially determined by applying the

broad determinants of health as described in the study’s conceptual framework, social cog-

nitive theory (Bandura, 2004). These themes

included knowledge, perceived barriers and facilitators, perceived self-efficacy, outcome

expectations, and goals. This approach permitted the investigators to examine the applicability of the theoretical framework

to the phenomenon of CPAP adherence and

elaborate on previous findings suggesting the framework’s concepts as measurable

predictors of CPAP-related health behaviors

(Aloia, Arnedt, Stepnowsky, et al., 2005;

Stepnowsky, Bardwell, et al., 2002; Wild

et al., 2004). Emergent subthemes were identi-

fied as thematic content analysis progressed. The subthemes were then categorized within

the overarching conceptual framework themes (see Table 3). We designed the analysis

strategy to be consistent with other recent

empirical studies of CPAP adherence while

permitting a more robust, narrative descrip-

tion of what these theoretically derived

variables mean from the perspective of the

OSA patient.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

ow wise

352 APPENDIX! © Diagnosis and Treatment of OSA and CPAP Therapy

Mixed Methods Analysis Procedure Analysis Output

Qualitative Data Preparation for Analysis Content

analysis

Interview text wees Text seus SS Highlighted text » . iy meaning data highlighted merged to one text unit

Qualitative Analysis: Within-Case Theme Identification

mien Condensed Interpretation of Highlighted text ———® meaning unit underlying meaning

extracted

meaning unit *

Qualitative Analysis: Within-Case Description

Salient

Narrative description: ization: descriptive iene —<o<ooS Hp ———> Categorization: ——— : P : beliefs, perceptions, & themes by social factors 0

CPAP use experiences cognitive theory

Quantitative Analysis: Descriptive Categorization Adherers

One-week Apply Categorization: and

CPAP use ; cut point CPAP usage nonadherers

(hrs/night) 6hrs/night to CPAP

Mixed Methods Analysis: Across-Case Description Typologies:

dh Adherers and Lots by Across-case: $ mies monadherers ws participant: —S— ‘none andre) “SI

to CPAP CPAP use by CPAP use nonadherers and all usage to CPAP

themes

Figure 3. Sequential analysis procedure.

Theme definitions were developed by reliability of the application of the codes to the investigators and reviewed by an expert the interview data. All extracted interview qualitative methodologist and an expert in the data were eligible for recoding; approximately research application of theoretical constructs. 15% of the data from each total interview One study investigator, blinded to CPAP were randomly selected for expert recoding. adherence data, coded all interview data for Agreement of the study coder and the expert the study. Valid application of the themes was coder was 94%, meeting the established examined by an independent expert coder. criteria of 80% agreement for acceptance of Coded interviews were independently recoded the coded data. When differences in applica- by the expert coder to establish validity and tion of codes were identified, code definitions

- APPENDIX! Diagnosis and Treatment of OSA and CPAP Therapy 353

Table 3 Social Cognitive Theory Determinants of Health as Categorizing Framework for Themes From Content Analysis A EE Es Ee eed ee ees ae ee eee er ee Determinants of Health

Behavior

Themesa Derived From Content Analysis

Knowledge

Perceived barriers and

facilitators

Fear of death

Gathering information about OSA/CPAP gives rise to determining

the importance of getting to treatment and decisions to accept/

reject treatment

Most immediate impact of OSA on daily life [single symptom] as a

motivator to pursue diagnosis and treatment

Justifying symptoms provides explanation for not pursuing

diagnosis and/or treatment

OSA impacts not only health but also quality of life

Pervasive effects of OSA on life

Sleepiness plays a limited role in life and can be accommodated

Perceived health effects of a disorder are important to valuing

diagnosis/treatment

Associating health risks and functional limitations with OSA

contributes to recognizing OSA as a health problem with

significant effects on overall well-being

Perception of seriousness of symptoms influenced by perceived

effects symptoms have on individual [health risks] and those

around individual [social network]

Perceived health risks of OSA

Information provided to individual and applicability of information

influences individual’s assumptions of responsibility for OSA

and CPAP treatment

Symptoms of OSA have impact on social roles, functions, and

relationships

Social influences as motivators to recognize health problem, seek

diagnosis/treatment, and use CPAP

Objective measures of OSA important to health care decision making

Differences in perception of urgency of treatment between patient

and provider influences valuing of diagnosis and treatment by

patient

Social networks contribute to treatment acceptance but not

necessarily to treatment use

Perceived seriousness of symptoms influenced by perceived

effects of symptoms on individual [health risks] and those

around individual

Social networks provide support, help problem solve health

concerns, and are sources of health-related information

commonality of symptoms of OSA promotes perception of

normalcy:

Barrier to seeking diagnosis/treatment

Reprinted

with permission.

(continued)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

twat see

) i)

354 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

Table 3 (continued) ee

Determinants of Health §Themesa Derived From Content Analysis

Behavior

Social influences as motivators to recognize health problem, seek

diagnosis and treatment, and use treatment

Silent symptoms: Fear of what it means if symptoms of OSA are

undetectable

Family and social networks contribute to health beliefs about sleep

Expectations of health delivery vs. the actual delivery of health

care services impact on the importance individual’s place on

their health and the value they place on their relationship with

health care providers

Perceived self-efficacy Knowledge and information provided to individual and

applicability of information influences individual’s assumption of

responsibility for OSA and CPAP treatment

Early response to CPAP, consistent or inconsistent with outcome

expectations, facilitates or is a barrier to treatment use

Early experience with CPAP is a source of support or a barrier to

belief in own ability to use treatment

Fitting treatment into life

Problem-solving difficulties/routinization of CPAP responsibilities

contribute to disease management

Outcome expectations Understanding why symptoms exist and associating specific

symptoms with a diagnosis provides hope that treatment will

address experienced symptoms and improve overall quality of

life

Expectations of treatment outcomes are facilitators of treatment

initiation and use

Early response to CPAP, consistent or inconsistent with outcome

expectations, facilitates or is a barrier to using treatment

Goals Problem-solving difficulties/routinization of CPAP responsibilities

contribute to disease management

“Themes derived from participant text data were categorized as a determinant of health behavior from social cognitive theory. Themes are not mutually exclusive. Theme definitions were mutually agreed on by investigators of the study and applied to the directed content analysis procedure by a single investigator acting as the primary coder of text data.

were reviewed by coders, discussion of CPAP use/night). Descriptive statistics were specific application of the code(s) was held, used in the analysis of 1 week of CPAP and mutual agreement was achieved in all adherence data (mean + $tandard devia-

instances of coding differences. tion [SD]). Across-case analysis of themes

After all interview data were coded for and subthemes was then examined from

themes, the investigators used the average an integrative perspective, using adherent

daily CPAP use during the first week of and nonadherent as anchors, or as a unique

treatment to separate adherers (> 6 hours descriptive qualifier, to identify common CPAP use/night) and nonadherers (< 6 hours perceptions, beliefs, and experiences within

ae APPENDIX | 5

the groups of interest. The across-case anal- ysis, including both qualitative and quanti- tative data sets as complementary within an

analysis matrix, gave rise to cases that had common descriptive aspects.

@ Results

With the recurrence of themes in the con-

tent analysis phase, data saturation was reached at 15 participants and the sampling

procedure was considered complete. The

participants were all veterans, predomi-

nantly middle-aged (53.9 + 12.7 years) men (88%; see Table 4). The participants were

well educated, with 93% (nm = 14) of the

sample achieving a high school education or

higher. The sample, on average, had severe OSA (AHI 53.5 + 26.5 events/hr), with

an oxygen nadir of 66.4% (+13.2%). The average CPAP pressure setting was 10.7 +

1.6 cm H,O. Average CPAP use during the

first 7 days of CPAP treatment was 4.98 +

0.5 hours/night. Sorting on CPAP adherence

(i.e. > 6 hrs/night CPAP use and < 6 hrs/night

CPAP use), there were six adherers and nine

nonadherers. The interview prior to CPAP

exposure was conducted after the diagnostic

polysomnogram, on average at Day 9 (range

2 to 28 days), and the second interview

was conducted following at least 1 week of

CPAP treatment (average number of days from Day 1 of CPAP use, 18; range 7 to 47

days).

ADHERERS AND NONADHERERS TO CPAP

THERAPY

Knowledge and Perceived Health Risks.

Knowledge, or the “knowing” an individual has about the health risks and benefits of health behaviors (Bandura, 2004) was a

predominant theme in both interviews for all participants. Saturation on nearly every

knowledge theme suggests that participants

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 355

Table 4 Sample Description ee

Characteristic Frequency (%) (n = 15)

Gender

Men 13 (87%)

Women 2 (13%)

Race/ethnicity

African American 9 (60%)

White 5 (33%)

Other 1 (7%)

Marital status

Married 7 (47%)

Single 3 (20%)

Divorced 3 (20%)

Widowed 2 (13%)

Highest education

Middle school 1 (7%)

High school 7 (47%)

2 yr college 4 (27%)

4+ yr college 3 (20%)

Shift work 3 (20%)

Employed 6 (40%) Retired 6 (40%)

Mean + Standard

Deviation

Age, years HS) az 27

Weight, pounds 248.9 + 68.7

AHI, events/hour 53.5 + 26.5

O, Nadir, % 66.4 + 13.2

CPAP pressure, 10.7 se 12

cmH,0

1 week CPAP 4.98 +0.5

adherence,

hours

identified that having an understanding of

OSA and CPAP is an important part of the experience of being diagnosed with OSA and

treated with CPAP. Adherent participants related their knowledge of risks and benefits of CPAP to their own outcome expectations

after being diagnosed with OSA. For some

participants, knowledge of OSA being simply more than snoring was a first step in

recognizing OSA as a syndrome with health

Generating and Assessing Evidence for Nursing Practice (11th ed.)

356 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

implications. One participant described this, saying, “I knew sleep apnea existed, but it just

never dawned on me how serious it was in my

case. I just didn’t pay any attention to it. I just

figured I was going to snore for the rest of my

lite: For many participants, “putting the whole

picture together” after receiving education

about OSA and CPAP treatment helped them understand that they not only were experi- encing symptoms of OSA on a daily basis,

but their overall health and quality of life was impacted by OSA. During the first interview, participants were provided with a summary of

their diagnostic sleep study results. The com-

bination of education about the OSA diag-

nosis and treatment with CPAP, and relating

their own diagnosis to their daily health and

functioning, was important to adherent par-

ticipants’ formulation of accurate beliefs and

perceptions of OSA and CPAP. These beliefs served to motivate or facilitate adherent par-

ticipants’ determination to pursue CPAP after diagnosis:

I didn’t know anything really, how the CPAP

worked or anything like that. I just knew that

there was a disease called sleep apnea and that

a lot of people have it and people don’t realize it. I really still didn’t know anything about it til

after I went through the test [diagnostic polysom-

nogram]. . . . Five [breathing events] is normal

and thirty is severe and I’m doing ninety an hour.

You know that literally scared the hell right out

of me because all I could think of is I’m going to die in my sleep.

[T]hen when you told me about driving, being

tired, I remembered that every time we take off

on a long trip, the first hour I got to pull over and

rest. So it all came together. So I figured maybe I do have it [OSA].

For many adherent participants, knowl- edge of health risks associated with OSA was limited to “being sluggish” or “having low energy levels.” For some, their perception of

OSA was only relative to “falling asleep when

I sit down.” Participants who “put the whole

picture together,” relating their diagnosis to their own health status, were motivated to

accept CPAP treatment from the outset. For

example, one participant said, “It’s [OSA]

got to take a toll in the long run on a lot of

things, like high blood pressure. I’m hoping that it helps me to drop my high blood pres-

sure.” These perceptions provided hope for adherent participants that expanded beyond the management of their OSA to other disease and health experiences:

If I have more energy and I’m not so sluggish—

because I go to the local high school track and get in five or six laps, walking around the track—I will have more energy to do those kinds of things

that keep you healthy.

Posttreatment, there was less emphasis on

knowledge-based themes among adherent par- ticipants. This suggested a shift of emphasis among adherers from knowledge of risks and benefits of OSA to perceptions derived from the actual experience of CPAP treatment.

Nonadherent participants’ knowledge at

diagnosis was not different from adherent participants’ knowledge. However, those with knowledge that served as a barrier, rather than a facilitator, to diagnosis were

less likely to pursue a diagnostic sleep study

in a timely fashion. This was particularly

true for those who had inaccurate knowledge and perceptions of OSA, such as OSA being

a condition of simple snoring. Even though many acknowledged they probably had OSA,

the snoring was the “problem” that defined OSA, not apneic events and resultant untow-

ard health and functional outcomes. As one participant described,

My brother does it [snores], and he stopped

[breathing] all the time in the middle of the night.

My father did it, you know, and I do it. I knew I

do it so it’s been a while, I mean, I don’t remem-

ber not being a loud snorer. . . . Like I said, my

condition is hereditary. 2m sure my oldest son

has it and I’m sure my youngest son is going to

end up with it. My brother had it and my father

had it, you know, my mother probably had it

‘cause she’s a snorer. I didn’t think it was seri-

ous of a problem ‘cause it’s [snoring, stops in

breathing] something that I had experienced for so many years.

me APPENDIX|

Furthermore, describing early knowledge of “having to wear a mask” for the treat- ment of OSA served as a barrier to both seeking diagnosis and treatment for some. This perception was not consistent among

only nonadherers though, as many of the participants expressed concerns about the anticipated treatment of their OSA. CPAP adherers and nonadherers described critically important differences in their own ability

to reconcile the following: (a) their OSA

diagnosis; (b) their experience of symptoms;

outcome expectations that were met after treatment exposure. These factors, when

reconciled by the individual, facilitated over- all positive perceptions of the diagnosis and treatment experience.

Goal Setting and Outcome Expectancies.

Outcome expectancies are the expected or anticipated costs and benefits for healthful habits/behaviors that support or deter from an individual’s investment in the behavior

(Bandura, 2004). Among the participants,

postdiagnosis outcome expectancies that

were consistently met were highly influential on participants’ decisions to use CPAP. For

example, after being diagnosed with OSA, one participant brought all his experienced

symptoms into perspective, relating them to

his OSA. With treatment, he was hopeful that these symptoms would resolve. He stated, “Tt seems like sleep apnea basically causes all those problems. So I figure if I can get this taken care of [by wearing CPAP], basically

the problems will subside.” Making sense of symptoms in terms of treatment outcome expectancies helped adherers commit to trying CPAP and believing that CPAP was going to be a positive experience. One participant

summarized his perception of symptoms and

outcome expectations like this: “But without

me even trying it I know that what Pm

experiencing and how it’s affected me, and that I want to get better if I can and so there’s nothing going to keep me away from getting

aAGPArsa

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 357

A particularly important perception

described by participants was their early

response to CPAP as influential on future/con- tinued use of CPAP. These early, first experi- ences were helpful to formulating realistic and

personally important outcome expectancies for CPAP use. One participant described his

response to CPAP after wearing it for the first time in the sleep laboratory during his second sleep study (i.e., CPAP sleep study):

But being like I got relief the first night I was at the hospital. I drove home that morning after they woke me up, I went down, I got breakfast,

and I’m driving home, I’m saying to myself, gee,

I feel great and I only got from one o’clock to six, you know. I feel so much better and I felt so

much better that whole day. I felt so good after

that five hours of sleep with the machine on that it sold me.

For adherent participants, having a positive response to CPAP during the sleep study night

with CPAP was highly motivating for con- tinued CPAP use at home. Furthermore, this

early response set the stage for participants to

develop an early commitment to the treatment, even when faced with barriers. Persistent,

positive responses to CPAP throughout the early treatment period (i.e., 1 week) reinforced

participants’ outcome expectancies and helped them formulate a perception of the treatment

that was conducive to longterm use. Goals for improved health and for achiev-

ing certain health behaviors are an import- ant part of being successful with any health

behavior. According to Bandura (2004),

individuals set goals for their personal health, including establishing concrete plans or strat-

egies for achieving those goals. Goal setting among adherent CPAP users focused on “how

best to adapt to using CPAP” or identifying “solutions to difficulties with use of CPAP.” These goals were established so that adher-

ent CPAP users were able to achieve their outcome expectations. Goal setting was not

specifically discussed by adherent participants before using CPAP. With exposure to and experience with CPAP, adherent participants

first identified that using CPAP was important

Generating and Assessing Evidence for Nursing Practice (11th ed.)

358 APPENDIX! #

and, thereafter, identified “tricks and tech-

niques” to successfully use CPAP. Whether

these strategies originated from the partici- pant or were a collaborative effort between participant and a support source, having a

plan that addressed how best to adapt to CPAP promoted continued effort directed at using CPAP, as described by one adherent participant:

I guess the first night I put it on I sort of got a

little feeling of claustrophobia, but I pushed it

out of my mind, saying to myself, “Don’t let this

[bother you], this is a machine that is going to

help you, you got to wear it,” so I just put it in

my mind that I was going to wear it.

As this participant described, it was import-

ant for him to devise a way that he could use the treatment so that he might realize his overall

health goals. Similarly, one participant found that he could not fall asleep with CPAP at full

pressure. He emphasized the importance of

using CPAP to treat his OSA, but he equated

using CPAP to “a tornado blowing through

your nose.” He recalled being taught about sey- eral features on the CPAP machine that might

alleviate this sensation. After testing a few tricks on the CPAP machine, he found that he was

able to fall asleep on a lower pressure setting

while the pressure increased to full pressure setting after he was asleep (i.e., ramp function).

By setting an immediate goal to get to sleep while wearing CPAP, he was able to achieve his longer-term goal to wear CPAP each night.

The long-term goal of adherent participants was to feel better or sleep better, but the immediate

goal was to be able to wear CPAP.

For nonadherers, a negative experience during their CPAP sleep study led them to have an undesirable outlook on CPAP and the overall treatment of OSA. For example, one

participant described experiencing no immedi- ate response to CPAP during the CPAP sleep

study; therefore, he didn’t expect to experi- ence any response to treatment over a more extended period of time:

I still had the same kind of sleep, I thought. As

a matter of fact I thought it took me longer to

get to sleep than it did on the first sleep study

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Diagnosis and Treatment of OSA and CPAP Therapy

[without CPAP]. I believe my sleep was still the

same type of sleep that I always get, even though,

you know, the machine was supposed to make

me sleep better. I still woke up in the same condi-

tion that I usually wake up in, is what ’m trying

to say. I didn’t feel any more vigorous or alert or

anything after that first night.

Participants’ descriptions of their consid- erations for using CPAP consistently included the question, “What are the down sides of

using CPAP?” Combining early negative per-

ceptions of the treatment and early negative experiences with CPAP, nonadherers tended to see the drawbacks of using the treatment as far outweighing any benefits of using the treatment. One participant described both

negative perceptions and negative experiences,

which caused him to believe that CPAP treat- ment outcome expectancies were not worth the torment of using the treatment:

No, I didn’t think I couldn’t do it from the begin-

ning. I was believing it was gonna do something

more than what it did, and it didn’t do anything.

I’m not getting sleep, I’m still getting up tired. I

guess I expected more from it and I didn’t get anything, not anything that I could see anyway.

No, just a bunch of botheration and IJ didn’t get any sleep.

Among participants who did not adhere,

the goal-oriented theme was not present after diagnosis. Nonadherers did not articulate specific goals for attaining treatment and, fur- thermore, they did not describe strategies to be able to wear CPAP after 1 week of CPAP treatment. For nonadherers, establishing treatment-related goals for use of CPAP was not a priority.

Facilitators of and Barriers to CPAP Use. Perceived facilitators and barriers can be personal, social, and/6r structural. Although

perceived facilitators and barriers are influential on health behaviors, this process

is mediated by self-efficacy (Bandura, 2004).

Therefore, the existence of a barrier, in and of

itself, might not be particularly influential on

an individual’s behavior if their self-efficacy is high. Consistent with this conceptual

Reprinted

with permission.

- APPENDIX!

perspective, some participants identified

barriers that were particularly troublesome when using CPAP, but were vigilant users

of CPAP despite these barriers. Conversely, those who described numerous facilitators to using CPAP treatment were not necessarily

adherent to CPAP. Adherent participants were less focused

on potential or actual facilitators and barriers

to using CPAP over time than nonadherers. When adherent participants discussed facili-

tators and barriers, their overall descriptions were positive, with facilitators being the

focus of their experience after using CPAP for 1 week. No adherent participants empha- sized barriers to using CPAP after 1 week

of treatment. Furthermore, when faced with

barriers, adherent participants described per- ceptions of the treatment as important and

identified a belief in their ability to overcome the barrier. For example, one participant

experienced a sensation of not being able to breathe during his second night of CPAP use at home, but his ability to use CPAP was

influenced by his commitment to “needing”

the treatment:

Because it was like I couldn’t breathe and even

though the machine was on, it was like I was

paralyzed, and this happened every time when

I tried to go back to sleep. How many times?

Three more times that very same night until I was getting really anxious because every time I

would try to go to sleep, after a while I would

get that anxiety again. Finally, I prayed. I got up and I prayed real hard, asked God to really

help me with this and I was right to sleep.

Ever since then, I pray every night and have

no problems.

As this example demonstrates, barriers and facilitators are not independent determinants of health behavior. Participants described

situations and experiences that were labeled as either a facilitator or barrier, but the actual

behavioral outcome of getting to diagnosis

and using CPAP was not necessarily reflec- tive of such experiences being a barrier or

facilitator. The facilitating experiences described

by adherent participants centered on social

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 359

interactions that provided motivation and facilitation of their CPAP use. Facilitating experiences included descriptions of social support, shared experiences of CPAP use with other CPAP users, and recognition that their own improvement as a result of

CPAP treatment was an important influence

on social relationships. Social relation- ships and the ability to be fully engaged in social interactions during their first week of

CPAP use was described by several adher- ent participants as a facilitator to ongoing treatment:

I see the difference. People see the difference. My wife sees the difference. My kids see the differ-

ence. That helps. I think that’s 50% of it. People telling you that you have changed and things

are getting better and you look a lot better and

you a sound a lot better and you act a lot better,

because when you have feedback like that you

know it’s [CPAP] helping.

Our relationship [with spouse] is getting better

and better. I think since the sleep machine it’s

even been more because some things that irri-

tate me, I would speak on and it would cause

like a little bit of friction, as it happens in cou-

ples. But since I’ve had the sleep machine, I’ve

been letting the minor things go, things that

irritate me or I would complain about before.

... Communication, our relationship, so we’ve

been able to talk more and enjoy each other

even more since then [starting CPAP]. Yeah, I

like the machine, I really do, and I like what

it’s doing.

Adherent participants clearly emphasized the importance of improved social relation-

ships as a result of their CPAP treatment.

Many recognized such improvements after a

close friend or family member suggested the

improvement was obvious. Nonadherent participants emphasized

barriers rather than facilitators to using

CPAP after being diagnosed with OSA. However, after using CPAP for 1 week, non- adherers identified few, if any, actual barriers to treatment. Unlike adherent participants,

nonadherers did not discuss social interac-

tions as an important part of their post-

CPAP treatment experience. Nonadherent

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

360 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

participants also identified themselves as Adherent participants also described that

single, divorced, or widowed, with the they planned to incorporate CPAP into their

exception of one participant. Nonadherers daily routine, suggesting an underlying pos-

did not discuss their social networks (i.e., itive belief in their ability to accomplish the

friends, family outside of their residence, health behavior-of using CPAP. Recognizing

coworkers) as important to their experiences

of being diagnosed with OSA and starting

CPAP treatment.

Perceived Self-efficacy. Perceived self-

efficacy is the belief that one can exercise control over one’s own health habits,

producing desired effects by one’s own health behaviors (Bandura, 2004). This

overarching theme was meaningfully

described by participants and represented

by several subthemes that were important to

both adherers and nonadherers in the study. Within these descriptions, participants

offered experiences with being diagnosed

with OSA and using CPAP that led to their

belief in themselves, or lack thereof, to use

or not use the treatment. Adherers in the sample described gener-

ally positive perceived self-efficacy regarding future use of CPAP. Adherers had a positive

belief in their ability to use CPAP from the outset, which persisted and became increas-

ingly frequent from diagnosis to early CPAP treatment, even if they first doubted their

ability to use the treatment. As one partici-

pant described, the first thought of wearing a mask during sleep was not appealing, but with a positive first experience with CPAP, the participant was increasingly confident that CPAP was going to be a part of his life:

I think I seen the masks sitting there and |

thought to myself, I hope I don’t have to wear

one of those things. Then they came in and said,

“Now we’re going to put the CPAP on you,” and

I said, “Okay,” and they put the CPAP on me

and when they came back into the room I felt

great when I woke up at six. They had to wake

me up at six o’clock because I was sleeping and

you know, I think I felt after that, I didn’t care

what it was if I got that much sleep from one o’clock to six without getting up. I was going to wear or do whatever I had to do to do it [wear CPAP].

Generating and Assessing Evidence for Nursing Practice (11th ed.)

that using CPAP would necessitate addi- tional daily “work,” adherers had well-

defined plans of incorporating the added

demands to their daily schedule:

I have to just add some things that I have to do

in order to keep the CPAP machine clean and

to make sure that it’s dry and each week I have

to disinfect it, but once I did it, once I decided

I was gonna do it, I just went in the bathroom,

did the whole thing, it only took about twenty

minutes, twenty-five minutes, and I was all

done. And getting up in the morning and doing

the daily cleaning, you know, that’s not a neg-

ative but it’s just something I have to make an

adjustment to.

Nonadherent participants described having largely negative experiences with

CPAP during the first exposure (i.e., CPAP

sleep study) or during the early phase of home CPAP use. Few nonadherent partic-

ipants experienced benefits with treatment

and nonadherers described unsuccessful or a lack of problemsolving efforts with CPAP difficulties. These negative experiences were

important areas of concern with regard to their perceived ability to use CPAP over the

long term (perceived self-efficacy). For exam-

ple, one participant had such an extremely negative experience during the first week he was exposed to CPAP that he firmly doubted his ability to ever use it:

I couldn’t breathe in [the mask]. This thing, I had

to suck in to get a breath out of it. Last night I

got a good night’s sleep but I woke up, then I

was claustrophobic. I felt like I was stuck under

a bed someplace and*couldn’t get out and then I

woke up. When I wore it the whole night through

I wasn’t sleeping so that’s one of the reasons [I

won't use CPAP], like I didn’t sleep with it on; it

was too aggravating.

Each participant described getting used to CPAP during the first several nights of treatment. With unsuccessful experiences

Reprinted

with permission.

a APPENDIX | 4

during this period, participants either identified resources to help improve their experience or made decisions to use CPAP

less or not at all. For all participants, early

experiences with CPAP contributed to their

belief in their own abilities to get used to the therapy.

Individuals who had difficulty fitting CPAP into their lives were challenged to be

adherent to the treatment. When CPAP was seen as not fitting into a life routine, partic- ipants offered doubts as to their ability to continue to use the treatment. One partic-

ipant described having a routine of falling asleep with television. With CPAP, she had difficulty watching television and therefore she experienced more difficulty getting to sleep. Although she continued to try to use CPAP, she expressed that using CPAP was

generally annoying to her. The complexities presented by using CPAP within the con-

straints of her normal routine were likely to

increasingly influence doubt in her ability to lise @ Rakes

MARRIED AND UNMARRIED CPAP USERS

With the emerging emphasis placed on social

support and social networks by adherers in

the study, we explored how the social context of daily life impacted on perceptions of OSA and CPAP treatment by examining married

(n = 7) and unmarried (v = 8) participants’

responses. Using married and unmarried

status from self-reported demographic characteristics as anchors, or as a unique

descriptive qualifier, we sorted the subthemes

within an analysis matrix to identify com-

mon perceptions, beliefs, and experiences within these qualifier groups. We included all participants who identified themselves as married or common-law married as married;

all participants who identified themselves as single, divorced, or widowed were included as

unmarried. These groups described different experi-

ences with both diagnosis and CPAP treatment.

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 361

Married participants offered descriptions of

social support resources within immediate

proximity that were positive facilitators of

seeking diagnosis and starting/staying on treat-

ment. Married participants expressed positive beliefs in their ability to use CPAP with early treatment use, often described in conjunc-

tion with a CPAP problem-solving episode that was collaboratively resolved with their

partner/spouse. Married participants described overwhelmingly positive early responses and

experiences with CPAP treatment. Their out-

come expectations were consistent across time.

They generally anticipated positive responses

to CPAP prior to exposure and experienced

positive responses to treatment after 1 week of

use. Married participants also identified success in “fitting CPAP into their lives.” These partic-

ipants were able to identify far more benefits from than difficulties with CPAP, benefits that

enhanced their ongoing commitment to use of

the treatment. Married participants discussed

proximate support sources (i.e., spouse, living

partner, family members) as important to pro-

viding feedback about their response to treat- ment, troubleshooting difficulties, and positive reinforcement for persistent use of CPAP.

Unmarried participants commonly iden-

tified friends or coworkers as motivating factors (facilitators) to seek diagnosis but less

social influence on/facilitation of treatment

use after 1 week of CPAP therapy. Without the presence of immediate social support, unmarried participants did not emphasize

important social interactions with actual wearing of CPAP. After 1 week of treatment

on CPAP, unmarried participants described less confidence in their ability to use CPAP and described less “response” to CPAP than those participants who were married. Unmarried participants described few facilita- tors of treatment use during the first week of

CPAP therapy. Nearly all unmarried partic-

ipants identified “self-driven” reasons for pursuing treatment, and there was an absence

of social sources of support, or “cheerleaders and helpful problem solvers” while using

CPAP during the first week.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

362 APPENDIX!

TYPOLOGIES OF ADHERENT AND NONADHERENT CPAP USERS

Described differences in beliefs, perceptions,

and experiences of being diagnosed with

OSA and early treatment with CPAP were

explicit between adherers and nonadherers.

Adherers perceived health and functional risks of untreated OSA, had positive belief in their ability to use CPAP from early in

the diagnostic process, had clearly defined outcome expectations, had more facilitators than barriers as they progressed from diagnosis to treatment,

and identified important social influences

and support sources for both pursuing diag-

nosis and persisting with CPAP treatment. Nonadherers described not knowing the

risks associated with OSA, perceived fewer

symptoms of their diagnosis, did not have

clearly defined outcome expectations for

treatment, identified fewer improvements

with CPAP exposure, placed less empha-

sis on social support and socially derived feedback with early CPAP treatment, and

perceived and experienced more barriers to

Diagnosis and Treatment of OSA and CPAP Therapy

CPAP treatment. As a result of the across- case analysis in which consistencies and

differences emerged among adherers and nonadherers in the described experience of being diagnosed*with OSA and treated with CPAP, we suggest typologies, or

descriptive profiles, of persons with CPAP- treated OSA (see Table 5). The typologies

we propose are consistent with previous

empirical studies of CPAP adherence, in

that predictive relationships between risk

perception, outcome expectancies, perceived self-efficacy, and social support with CPAP use have been identified. Our study findings extend the previous findings by illuminating the importance of contex- tual meaning persons derive from their

experiences, beliefs, and perceptions when progressing from diagnosis with OSA to

treatment with CPAP. Moreover, the typol-

ogies succinctly describe critical differences

between these groups of CPAP-treated OSA persons that support the development of patient-centered or -tailored adherence

interventions that recognize individual differences.

Table 5 Typologies of Adherent and Nonadherent CPAP Users

Adherent CPAP Users Nonadherent CPAP Users

Define risks associated with OSA

Identify outcome expectations from outset

Have fewer barriers than facilitators

Facilitators less important later with

treatment use

Develop and define goals and reasons for

CPAP use

Describe positive belief in ability to use

CPAP even with potential or experienced

difficulties

Proximate social influences prominent

in decisions to pursue diagnosis and

treatment

Unable to define risks associated with OSA

Describe few outcomes expectations

Do not recognize own symptoms

Describe barriers as more influential on

CPAP use than facilitators

Facilitators of treatment absent or

unrecognized x

Describe low belief in ability to use CPAP

Describe early negative experiences with

CPAP, reinforcing low belief in ability to

use CPAP

Unable to identify positive responses to

CPAP during early treatment

Generating and Assessing Evidence for Nursing Practice (11th ed.) Reprinted

with permission.

= APPENDIX! #8

= Discussion

To our knowledge, this is the first study to apply a predominantly qualitative method to describe individuals’ beliefs and percep- tions of the diagnosis of OSA and treatment

with CPAP relative to short-term CPAP

adherence. Our findings are consistent with

previous, empirical studies with regard to the overall applicability of social cogni- tive theory to the phenomenon of CPAP

adherence. The findings from our study uniquely extend these previous findings by illuminating the importance of the individ- ual experiences, beliefs, and perceptions as influential on decisions to pursue diagno- sis and treatment of OSA. The described differences between adherers and nonadher-

ers in our study suggest critical tailored or

patient-centered intervention opportunities

that might be developed and tested among patients who are newly diagnosed with OSA

and anticipate CPAP treatment. The major findings of the study include the following: (a) adults described and assigned meaning

to being diagnosed with OSA and treated

with CPAP, which in turn influenced their

decisions to accept or reject treatment and

the extent of CPAP use; and (b) differences

in beliefs and perceptions at diagnosis and

with CPAP treatment were identified among

CPAP adherers and nonadherers and also described in the social context of married and unmarried CPAP users. The described

differences between these groups provide data to support the first published typology, or descriptive profile, of CPAP adherers and nonadherers.

Theoretically derived variables, such

as the determinants of health behaviors

described in social cognitive theory and applied in our study, are operational

concepts that help us understand OSA patients’ perceptions and beliefs about OSA and CPAP, and can guide interventions to

improve adherence to CPAP. Framed by Bandura’s social cognitive theory (1977), differences among adherers and nonadherers

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 363

to CPAP can be defined across social cogni- tive theory determinants of health behaviors: (a) knowledge, (b) perceived self-efficacy,

facilitators and barriers. As previous studies have demonstrated, psychosocial constructs,

such as those consistent with social cognitive theory, provide possibly the most explained

variance, to date, among adherers and non-

adherers (Aloia, Arnedt, Stepnowsky, et al.,

2005; Engleman & Wild, 2003; Stepnowsky,

Bardwell, et al., 2002; Weaver et al., 2003).

Furthermore, recent intervention studies

to promote CPAP adherence have applied similar theoretical constructs with some positive findings (Aloia, Arnedt, Millman, et

al., 2007; Richards, Bartlett, Wong, Malouff,

& Grunstein, 2007). As our study findings suggest, decisions to use CPAP are individ-

ualized and at least in part dependent on the patient’s support environment and early

experiences with and beliefs about CPAP. Because early commitments to use or not use

CPAP predict long-term use (Aloia, Arnedt,

Stanchina, et al., 2007; Weaver, Kribbs, et

al., 1997), it is critically important to under-

stand and examine opportunities to intervene

on factors that influence early commitments

to use CPAP. This insight will potentiate the development of patientcentered and-tailored interventions to improve CPAP adherence at the individual level while collectively

promoting the health outcomes of the OSA

population. Our study confirms that social cognitive

theory is applicable to the unique health behavior of using CPAP treatment. Indeed, the interacting determinants of health as

described by Albert Bandura (1977) in

relationship to decisions to accept and use

CPAP were clearly described by our study participants. This affirmation suggests that

any one measured domain within the model

(i.e., barriers, facilitators, outcome expec-

tancies) is not likely to identify persons at

risk for nonadherence to CPAP. Rather,

our study findings support the complex

and reciprocating nature of the theoretical

model as it applies to this health behavior,

Generating and Assessing Evidence for Nursing Practice (11th ed.)

ro ee Mi hh = a

364 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

and offer clarity to our understanding of CPAP adherence as a multifactorial, itera-

tive decisionmaking process. It is therefore

important to ascertain an understanding of the context of the individual from the initial diagnosis through early treatment use to address the complex nature of the problem of adherence to CPAP and to prospectively

identify those likely to be nonadherent to

the treatment. In our study, the experience and percep-

tion of symptoms contributed to the par-

ticipants’ motivation to seek diagnosis and

treatment and to adhere to CPAP treatment.

Although studies that have examined pre- treatment symptoms, particularly subjective

sleepiness, have produced inconsistent results

with regard to subsequent CPAP use, these

studies have measured symptoms on quan- titative scales that define specific scenarios of “impairment” related to the symptom

of interest (i.e., Epworth Sleepiness Scale

(Johns, 1993), Functional Outcomes of

Sleep Questionnaire (Weaver, Laizner, et al.,

1997), Stanford Sleepiness Scale (MacLean,

Fekken, Saskin, & Knowles, 1992; Engleman

et al., 1996; Hui et al., 2001; Janson, Noges,

Svedberg-Randt, & Lindberg, 2000; Kribbs et al., 1993; Lewis et al., 2004; McArdle

et al., 1999; Sin et al., 2002; Weaver,

Laizner, et al., 1997). Yet, as our study high-

lights, perceptions of need relative to one’s

experience of symptoms were highly indi- vidual and significantly influenced decisions

to pursue both diagnosis and treatment. Consistent with perceptions that influence

medicine-taking behavior (Hansen, Holstein,

& Hansen, 2009), particular situations

necessitated the pursuit of diagnosis and use

of the treatment. The experience of symp- toms and the impact of symptoms on daily

life were highly variable among participants

and not readily amenable to discrete catego-

rization. Understanding particular situations

is important insight to explaining adherence to CPAP.

Recognizing and acknowledging that perceived symptoms are part of a disease

process and logically linked to the diagnosis

of OSA was important to the participants of

our study, and to their commitment to move

forward from diagnosis to treatment, con- sistent with Engleman and Wild’s findings (2003). A recent*intervention study to pro-

mote CPAP adherence incorporated specific strategies that address “personalization” of OSA symptoms (Aloia, Arnedt, Riggs, Hecht, & Borrelli, 2004; Aloia, Arnedt, Millman,

et al., 2007). Results of this randomized

controlled trial showed lower CPAP discon- tinuation rates among those participants who

were in the motivational enhancement and education group when compared with “usual care,” suggesting the importance of assisting

persons diagnosed with OSA to make the

connection between the objectively measured

disease/diagnosis and their lived experience of the disease (Aloia, Arnedt, Millman, et al.,

2007). Personalizing symptoms, recognizing

the impact of symptoms on daily function,

and identifying the meaning of disease in terms of the perception of one’s own health

were clearly described by participants in our study. Adherent and nonadherent

participants clearly expressed differences in

their experiences of having OSA, including

the impact of functional impairment on

social relationships. From these differing perspectives, participants defined outcome

expectations and health risks associated with OSA in different ways, possibly influencing

their eventual decision to use or discontinue CPAP,

The described importance of participants’ early experiences with CPAP and their initial response to CPAP treatment, both during the

CPAP sleep study and during the first week of CPAP use, were influential on participants’

interest in continuing to use CPAP. Our study

results are consistent with Van de Mortel,

Laird, and Jarrett’s (2000) findings in which

nonadherent, CPAP-treated OSA patients had complaints about their sleep study experience

and described “major” problems on the night

of their CPAP titration. Similarly, Lewis et al.

(2004) found that problems identified on the

first night of CPAP use, albeit on autotitrating

CPAP, were consistent with lower CPAP use.

- APPENDIX! #8

Not only has the initial experience in terms

of difficulties with CPAP been identified as important to subsequent CPAP adherence, but also the patient’s response to the first night of CPAP (i.e., degree of sleep improvement) has been correlated with subsequent CPAP adher- ence (Drake et al., 2003). The importance of

promoting a positive initial experience with

CPAP and providing anticipatory guidance about outcome expectations is highlighted by our findings.

The significance of social support, both proximate and within the broader social

network, was an important facilitator of CPAP use among adherers in our study.

Differences between the experiences of married and unmarried individuals with

OSA revealed the described importance of

an immediate, proximate source of support

for CPAP use. Our finding is consistent with previous findings that those CPAP users who lived alone were significantly less likely

to use their CPAP than those who lived with

someone (Lewis et al., 2004). Not only are

immediate sources of support important for continued use of CPAP, but also shared

experiences with CPAP from less-immediate social sources. Participants in our study

described social relationships as motivators to seek diagnosis, providing positive rein-

forcement for persisting with treatment use,

and a source for sharing tips on managing OSA and CPAP. Studies exploring reasons

for nonadherence to antituberculosis drugs

have similarly identified the importance of social influences on seeking treatment

and using treatment (Naidoo, Dick, &

Cooper, 2009). Among CPAP-treated OSA

patients, intervention studies that included feedback to participants, positive reinforce- ment, inclusion of a support person, and assistance with troubleshooting difficulties resulted in higher CPAP adherence among participants in the intervention groups as

compared with placebo or usual-care groups

(Aloia et al., 2001; Chervin, Theut, Bassetti,

& Aldrich, 1997; Hoy, Vennelle, Kingshott,

Engleman, & Douglas, 1999). Confirming

the applicability of these intervention

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 365

strategies, the described experiences of participants in our study provide empirical support for adherence interventions that include a support person, provide early feedback and positive reinforcement to patients, and assist with trouble-shooting difficulties in the early treatment period.

Barriers to subsequent CPAP use that

were identified by participants of our study

included the process of having to put a

mask on every night, aesthetic issues with

mask/headgear use, inconvenience of having to use a machine to sleep, and daily routines that were disrupted by CPAP. Consistent with previous studies (Engleman et al.,

1994; Hui et al., 2001; Massie et al., 1999;

Sanders et al., 1986), side effects of CPAP

were not emphasized by participants as barriers to CPAP use. Although identified barriers did not necessitate nonadherence

to CPAP in our study, it was important for individuals who experienced such barriers

to identify positive reasons to use CPAP and successfully mitigate barriers, often with the

help of others. This study had several limitations. First,

although the sample size of 15 was ade-

quate for a qualitative study, there was limited power to conduct any exploratory

quantitative analyses. Although not the objective of this study, quantitative explora- tion of commonly used measures of subjec-

tive sleepiness, functional impairment, and

adherence to CPAP correlated with descrip- tive, quantified typologies of adherent and

nonadherent CPAP users would support the findings of the study. Study participants included predominantly male veterans with severe OSA who had relatively high educa- tional preparation. Examining this typology

in a larger, more heterogeneous sample of

OSA patients is needed. As the relationship of gender, disease severity, symptom percep-

tion, and disease-specific literacy with CPAP adherence has not been clearly defined,

replicating this study in a more diverse sam-

ple and expanding concurrently measured

quantitative outcomes would be informative

and supportive of typology refinement or

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

366 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

expansion. Finally, to reduce the potential

confounding effect of clinically delivered

psychoeducation, we enrolled participants referred to the study from a single clinical

provider with limited participant—pro- vider interaction at the first prediagnostic

evaluation. However, participants may have had telephone contact with the sleep center staff, or had unscheduled visits at the sleep

center that were not controlled for in any

way in our study.

Our mixed methods, exploratory study,

employing a predominantly qualitative methodology, achieved saturation of themes regarding the diagnosis of OSA and nightly

CPAP use during the first week of treat- ment. The study results are consistent with

previous studies of CPAP, even when adher-

ence, in many previous studies, was defined

as four hours/night of use rather than six

hours/night of use, as in our study. With

recent evidence suggesting better outcomes with longer nightly CPAP use (Stradling

& Davies, 2000; Weaver et al., 2007;

Zimmerman, Arnedt, Stanchina, Millman,

& Aloia, 2006), applying a definition of

CPAP adherence of six hours vs. four hours likely contributed to more robust differ-

ences in described beliefs and perceptions

among adherers and nonadherers. To our

knowledge, the results of our study provide

the first published, narrative descriptions of CPAP adherers and nonadherers that support an overall composite of charac- teristics that might be useful in identifying

specific subgroups of patients who are most likely to benefit from tailored interventions

to lessen the risk for subsequent CPAP non-

adherence. To date, studies have provided adherence promotion interventions to unse-

lected groups, possibly minimizing variation

of response between intervention and con- trol groups. Future randomized controlled trials testing CPAP adherence interventions delivered to participants who are selected based on their risk for treatment failure because of nonadherence are necessary to evaluate intervention

effectiveness.

B# Acknowledgments

We acknowledge the sleep center staff’s commitment to the conduct and completion of the study, and the exemplary transcrip- tion services provided by Charlene Hunt at Transcribing4 You~Homework4 You.

® Declaration of Conflicting

Interests

The authors declared a potential conflict of interest (e.g., a financial relationship with

the commercial organizations or products discussed in this article) as follows: Dr.

Kuna has received contractural support and

equipment from Phillips Respironics, Inc.

Dr. Weaver has a licensing agreement with Phillips Respironics, Inc., for the Functional Outcomes of Sleep Questionnaire.

@ Funding

The authors disclosed receipt of the following financial support for the research and/author- ship of this article: The study was supported

by award number F31NR9315 (Sawyer) from

the National Institute of Nursing Research.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Nursing Research or the National Institutes of Health.

Bios

Amy M. Sawyer, PhD; RN, is a postdoctoral research

fellow at the University of Pennsylvania School of

Nursing, Philadelphia, Pennsylvania, and a nurse

researcher at the Philadelphia Veterans Affairs

Medical Center, Philadelphia, Pennsylvania, USA.

Janet A. Deatrick, PhD, RN, FAAN, is an associate

professor and associate director, Center for Health

Equities Research, at the University of Pennsylvania

School of Nursing, Philadelphia, Pennsylvania, USA.

- APPENDIX | =

Samuel T. Kuna, MD, is an associate professor of

medicine at the University of Pennsylvania School

of Medicine and chief, Pulmonary, Critical Care

and Sleep Medicine, at the Philadelphia Veterans

Affairs Medical Center, Philadelphia, Pennsylvania, USA.

Terri E. Weaver, PhD, RN, FAAN, is the Ellen

and Robert Kapito Professor in Nursing Science,

chair, Biobehavioral Health Sciences Division,

and associate director, Biobehavioral Research

Center, at the University of Pennsylvania School

of Nursing, Philadelphia, Pennsylvania, USA.

Corresponding Author: Amy M. Sawyer, University of Pennsylvania

School of Nursing, Claire M. Fagin Hall, 307b, 418 Curie Blvd.,

Philadelphia, PA 19104, USA Email: asawyer@ nursing.upenn.edu

REFERENCES Al Lawati, N. M., Patel, S., & Ayas, N. T. (2009).

Epidemiology, risk factors, and consequences of obstructive sleep apnea and short sleep duration. Progress in Cardiovascular Diseases, 51, 285-293.

Aloia, M. S., Arnedt, J., Riggs, R. L., Hecht, J., &

Borrelli, B. (2004). Clinical management of poor adherence to CPAP: Motivational enhancement. Behavioral Sleep Medicine, 2(4), 205-222.

Aloia, M. S., Arnedt, J. T., Millman, R. P., Stanchina,

M.., Carlisle, C., Hecht, J., et al. (2007). Brief behay-

ioral therapies reduce early positive airway pressure discontinuation rates in sleep apnea syndrome: Preliminary findings. Behavioral Sleep Medicine, 5, 89-104.

Aloia, M. S., Arnedt, J. T., Stanchina, M., & Millman,

R. P. (2007). How early in treatment is PAP adher-

ence established? Revisiting night-to-night variabil- ity. Behavioral Sleep Medicine, 5, 229-240.

Aloia, M. S., Arnedt, J. T., Stepnowsky, C., Hecht, J.,

& Borrelli, B. (2005). Predicting treatment adherence in obstructive sleep apnea using principles of behav- ior change. Journal of Clinical Sleep Medicine, 1(4),

346-353. Aloia, M. S., Di Dio, L., IIniczky, N., Perlis, M. L.,

Greenblatt, D. W., & Giles, D. E. (2001). Improving

compliance with nasal CPAP and vigilance in older adults with OAHS. Sleep and Breathing, 5(1), 13-21.

American Academy of Sleep Medicine Task Force. (1999). Sleep-related breathing disorders in adults: Recommendations for syndrome definitions and measurement techniques in clinical research. Sleep,

22, 667-689.

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 367

Bandura, A. (1977). Self-efficacy: Toward a unifying theory of behavioral change. Psychological Reviews, 84, 191-215.

Bandura, A. (1992). Exercise of personal agency

through the self-efficacy mechanism. In Schwarzer,

R. (Ed.), Self-efficacy: Thought control of action (pp. 3-38). Philadelphia: Hemisphere.

Bandura, A. (2002). Social cognitive theory in cultural context. Applied psychology: An International Review, 51(2), 269-290.

Bandura, A. (2004). Health promotion by social cog- nitive means. Health Education & Behavior, 31(2),

143-164.

Chervin, R. D., Theut, S., Bassetti, C., & Aldrich,

M. S. (1997). Compliance with nasal CPAP can be

improved by simple interventions. Sleep, 20, 284-289. Creswell, J. W., Plano Clark, V. L., Gutmann, M. L.,

& Hanson, W. (2003). Advanced mixed methods

research designs. In Tashakkori, A. & Teddlie, C. (Eds.), Handbook of mixed methods in social &

behavioral research (pp. 209-240). Thousand Oaks, CA: Sage.

Drake, C. L., Day, R., Hudgel, D., Stefadu, Y., Parks,

M., Syron, M. L., et al. (2003). Sleep during titration predicts continuous positive airway pressure compli- ance. Sleep, 26, 308-311.

Engleman, H. M., Asgari-Jirandeh, N., McLeod, A. L.,

Ramsay, C. F., Deary, I. J., & Douglas, N. J. (1996).

Self-reported use of CPAP and benefits of CPAP therapy. Chest, 109, 1470-1476.

Engleman, H. M., Martin, S. E., & Douglas, N. J.

(1994). Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Thorax, 49, 263-266.

Engleman, H. M., & Wild, M. (2003). Improving CPAP

use by patients with the sleep apnoea/hypopnoea syn- drome (SAHS). Sleep Medicine Reviews, 7(1), 81-99.

Gay, P., Weaver, T., Loube, D., & Iber, C. (2006).

Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. Sleep, 29, 381-401.

Graneheim, U. H., & Lundman, B. (2004). Qualitative

content analysis in nursing research: Concepts,

procedures and measures to achieve trustworthiness.

Nursing Education Today, 24, 105-112.

Grunstein, R. R., Stewart, D. A., Lloyd, H., Akinci, M., Cheng, N., & Sullivan, C. E. (1996). Acute

withdrawal of nasal CPAP in obstructive sleep apnea does not cause a rise in stress hormones. Sleep, 19,

774-782.

Hansen, D. L., Holstein, B. E., & Hansen, E. H.

(2009). “I'd rather not take it, but...”: Young wom-

en’s perceptions of medicines. Qualitative Health

Research, 19, 829-839. Harsch, I., Schahin, S., Radespiel-Troger, M., Weintz,

O., Jahrei, H., Fuchs, S., et al. (2004). Continuous

positive airway pressure treatment rapidly improves

insulin sensitivity in patients with obstructive sleep

apnea syndrome. American Journal of Respiratory o

Critical Care Medicine, 169, 156-162.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

SERS oe ae

368 APPENDIX! #

Hoy, C. J., Vennelle, M., Kingshott, R. N., Engleman,

H. M., & Douglas, N. J. (1999). Can intensive

support improve continuous positive airway pressure

use in patients with the sleep apnea/hypopnea syn- drome? American Journal of Respiratory & Critical Care Medicine, 159, 1096-1100.

Hsieh, H., & Shannon, S. (2005). Three approaches

to qualitative content analysis. Qualitative Health Research, 15, 1277-1288.

Hui, D., Choy, D., Li, T., Ko, F., Wong, K., Chan, J.,

et al. (2001). Determinants of continuous positive airway pressure compliance in a group of Chinese

patients with obstructive sleep apnea. Chest, 120, 170-176.

Janson, C., Noges, E., Svedberg-Randt, S., & Lindberg, E. (2000). What characterizes patients who are unable to tolerate continuous positive airway pres- sure (CPAP) treatment? Respiratory Medicine, 94, 145-149.

Johns, M. (1993). Daytime sleepiness, snoring, and

obstructive sleep apnea. The Epworth Sleepiness Scale. Chest, 103, 30-36.

Kribbs, N. B., Pack, A. I., Kline, L. R., Smith, P. L., Schwartz, A. R., Schubert, N. M., et al. (1993).

Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. American Review of Respiratory Diseases, 147, 887-895.

Krieger, J. (1992). Long-term compliance with nasal

continuous positive airway pressure (CPAP) in

obstructive sleep apnea patients and nonapneic snorers. Sleep, 15, S42-S46.

Lewis, K., Seale, L., Bartle, I. E., Watkins, A. J., &

Ebden, P. (2004). Early predictors of CPAP use for

the treatment of obstructive sleep apnea. Sleep, 27, 134-138.

MacLean, A. W., Fekken, G. C., Saskin, P., &

Knowles, J. B. (1992). Psychometric evaluation

of the Stanford Sleepiness Scale. Journal of Sleep Research 1, 35-39.

Massie, C., Hart, R., Peralez, K., & Richards, G. (1999). Effects of humidification on nasal symp-

toms and compliance in sleep apnea patients using continuous positive airway pressure. Chest, 116,

403-408. McArdle, N., Devereux, G., Heidarnejad, H.,

Engleman, H. M., Mackay, T., & Douglas, N. J. (1999). Long-term use of CPAP therapy for sleep apnea/hypopnea syndrome. American Journal of Respiratory and Critical Care Medicine, 159, 1108-1114.

Meurice, J. C., Dore, P., Paquereau, J., Neau, J. P.,

Ingrand, P., Chavagnat, J. J., et al. (1994). Predictive

factors of long-term compliance with nasal continu- ous positive airway pressure treatment in sleep apnea

syndrome. Chest, 105, 429-434. Naidoo, P., Dick, J., & Cooper, D. (2009). Exploring

tuberculosis patients’ adherence to treatment reg- imens and prevention programs at a public health site. Qualitative Health Research 19, 55-70.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Diagnosis and Treatment of OSA and CPAP Therapy

Nieto, F., Young, T., Lind, B., Shahar, E., Samet, J., Redline, S., et al. (2000). Association of sleepdis-

ordered breathing, sleep apnea, and hypertension in a large community-based study. Journal of the American Medical Association, 283, 1829-1836.

Peppard, P., Young; T., Palta, M., & Skatrud, J.

(2000). Prospective study of the association between sleep-disordered breathing and hyper- tension. New England Journal of Medicine, 342, 1378-1384.

Rechtschaffen, A.,, & Kales, A,. (Eds.). (1968). A

manual of standardized terminology, techniques and scoring system for sleep stages in human subjects.

Los Angeles: BIS/BRI. Reeves-Hoche, M. K., Meck, R., & Zwillich, C. W.

(1994). Nasal CPAP: An objective evaluation of patient compliance. American Journal of Respiratory c& Critical Care Medicine, 149, 149-154.

Richards, D., Bartlett, D. J., Wong, K., Malouff, J.,

& Grunstein, R. R. (2007). Increased adherence to

CPAP with a group cognitive behavioral treat-

ment intervention: A randomized trial. Sleep, 30, 635-640.

Rosenthal, L., Gerhardstein, R., Lumley, A., Guido, P.,

Day, R., Syron, M. L., et al. (2000). CPAP therapy in

patients with mild OSA: Implementation and treat- ment outcome. Sleep Medicine, 1, 215-220.

Russo-Magno, P., O’Brien, A., Panciera, T., &

Rounds, S. (2001). Compliance with CPAP therapy in older men with obstructive sleep apnea. Journal of American Geriatric Society, 49, 1205-1211.

Sanders, M. H., Gruendl, C. A., & Rogers, R. M.

(1986). Patient compliance with nasal CPAP therapy for sleep apnea. Chest, 90, 330-333.

Schwarzer, R., & Fuchs, R. (1996). Self-efficacy and

health behaviours. In Conner, M. & Norman, P.

(Eds.), Predicting health behaviour: Research and

practice with social cognition models (pp. 163-196). Philadelphia: Open Press.

Schweitzer, P., Chambers, G., Birkenmeier, N., &

Walsh, J. (1997). Nasal continuous positive airway pressure (CPAP) compliance at six, twelve, and

eighteen months. Sleep Research, 16, 186. Sin, D., Mayers, I., Man, G., & Pawluk, L. (2002).

Long-term compliance rates to continuous positive

airway pressure in obstructive sleep apnea: A population-based study. Chest, 121, 430-435.

Stepnowsky, C., Bardwell, W. A., Moore, P. J., Ancoli- Israel, S., & Dimsdale, J. E. (2002). Psychologic

correlates of compliance with continuous positive airway pressure. Sleep, 25, 758-762.

Stepnowsky, C., Marler, M. R., & Ancoli-Israel, S.

(2002). Determinants of nasal CPAP compliance. Sleep Medicine, 3, 239-247.

Stradling, J., & Davies, R. (2000). Is more NCPAP

better? Sleep, 23, $150-S153. Streubert Speziale, H., & Carpenter, D. (2003).

Qualitative research in nursing (3rd ed.). Philadelphia: Lippincott Williams & Wilkins.

Reprinted

with permission.

- APPENDIX! #8

Sullivan, C., Barthon-Jones, M., Issa, F., & Eves, L.

(1981). Reversal of obstructive sleep apnea by con-

tinuous positive airway pressure applied through the nares. Lancet, 1, 862-865.

Tashakkori, A., & Teddlie, C. (1989). Mixed meth-

odology: Combining qualitative and quantitative approaches. London: Sage.

Van de Mortel, T. F., Laird, P., & Jarrett, C. (2000). Client perceptions of the polysomnography experi- ence and compliance with therapy. Contemporary Nurse, 9, 161-168.

Weaver, T. E., & Grunstein, R. R. (2008). Adherence

to continuous positive airway pressure therapy: The challenges to effective treatment. Proceedings of the American Thoracic Society, 5, 173-178.

Weaver, T. E., Kribbs, N. B., Pack, A. I., Kline, L. R.,

Chugh, D. K., Maislin, G., et al. (1997). Night-

tonight variability in CPAP use over first three months of treatment. Sleep, 20, 278-283.

Weaver, T. E., Laizner, A. M., Evans, L. K., Maislin,

G., Chugh, D. K., Lyon, K., et al. (1997). An instru-

ment to measure functional status outcomes for disorders of excessive sleepiness. Sleep, 20, 835-843.

Weaver, T. E., Maislin, G., Dinges, D. F., Bloxham,

T., George, C. F. P., Greenberg, H., et al. (2007).

Relationship between hours of CPAP use and achiev- ing normal levels of sleepiness and daily functioning. Sleep, 30, 711-719.

Reprinted

with permission.

Diagnosis and Treatment of OSA and CPAP Therapy 369

Weaver, T. E., Maislin, G., Dinges, D. F., Younger, J.,

Cantor, C., McCloskey, S., et al. (2003). Self-efficacy

in sleep apnea: Instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep, 26, 727-732.

Wild, M., Engleman, H. M., Douglas, N. J., & Espie, C. A. (2004). Can psychological factors help us to determine adherence to CPAP? A prospective study. European Respiratory Journal, 24, 461-465.

Young, T., Palta, M., Dempsey, J., Skatrud, J., Weber, S., & Badr, S. (1993). The occurrence of sleep-

disordered breathing among middle-aged adults. New England Journal of Medicine, 328, 1230-1235.

Young, T., Peppard, P., & Gottlieb, D. (2002).

Epidemiology of obstructive sleep apnea: A population health perspective. American Journal of Respiratory & Critical Care Medicine, 165, 1217-1239.

Zimmerman, M. E., Arnedt, T., Stanchina,

M., Millman, R. P., & Aloia, M. S. (2006). Normalization of memory performance and positive airway pressure adherence in memory-impaired

patients with obstructive sleep apnea. Chest, 130, 1772-1778.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

CRITICAL APPRAISAL OF SAWYER

ET AL. S STUDY ' DIFFERENCES

IN PERCEPTIONS OF DIAGNOSIS AND TREATMENT OF OBSTRUCTIVE SLEEP APNEA AND CONTINUOUS PosiTivE AIRWAY PRESSURE THERAPY AMONG ADHERERS AND NON-ADHERERS .

# Overall Summary

This was a well-written, interesting report describing a study on a significant topic. The mixed methods QUAL+ quan approach

that was used was ideal for combining rich

narrative interview data with objective,

quantitative measures of adherence to con-

tinuous pOsitive airway pressure treatment.

The use of a longitudinal design enabled

the researchers to gain insights into changes

in patients’ perceptions from diagnosis to

treatment. The study design and methods were described in commendable detail, and

the methods used were of exceptionally high quality. The authors provided consid- erable information about how the

trustworthiness of the study was enhanced.

The results were nicely elaborated and the

researchers incorporated numerous excerpts from the interviews. This was, overall, an

excellent paper describing a very strong study.

# Title

The title of this report was long and perhaps

a few words could have been omitted (e.g.,

“differences in” could be removed without affecting readers’ understanding of the study).

Nevertheless, the title did describe key aspects

of the research. The title conveyed the central

topic (perceptions about obstructive sleep apnea [OSA] and continuous positive airway pressure

[CPAP] therapy). It also communicated the

nature of the analysis, which compared percep-

tions of adherers and non-adherers to CPAP.

If this paper had been published in a different journal, it probably would Have been desirable

to communicate in the title that the study was primarily qualitative, but inasmuch as it was

published in Qualitative Health Research, that was not necessary. (However, “qualitative” was

not used as a keyword for retrieving this study,

either. The keywords included “content analy-

sis” and “mixed methods,” but in a search for

qualitative studies on OSA or CPAP, this paper might be missed).

APPENDIX!

& Abstract

As required by Qualitative Health Research (QHR), the abstract was written as a tradi-

tional abstract (no subheadings) of 150 words

or fewer. Although brief, the abstract clearly described major aspects of the study so that readers could quickly learn whether the entire

paper might be of interest. The first sentence of the abstract described the significance of

the topic. The methods were succinctly pre- sented, describing the overall mixed methods

design, the longitudinal nature of the study

(2 rounds of interviews), the sample (15 OSA

patients), the basic type of analysis (con-

tent analysis), and the focus on comparing

adherent and non-adherent patients using

objectively measured CPAP use. The use of

social cognitive theory to guide the inquiry

was noted. Although specific results were not described, the abstract indicated areas

in which differences between adherers and non-adherers were observed. Finally, the last sentence suggests some possible applications

for the results in terms of developing tailored interventions to promote CPAP use.

# Introduction

The introduction to this article was concise and

well-organized. It began with a paragraph about

OSA as an important chronic health problem,

describing its prevalence, its effects, and its

primary medical treatment, i.e., CPAP. This first

paragraph helps readers understand the signifi-

cance of the topic. The rest of the introduction mostly dis-

cussed CPAP adherence, which has consistently

been found to be low. The researchers nicely

set the stage for their study by summarizing

evidence about rates of adherence and factors

predicting adherence. They also described prior

research that affected some of their design

decisions, such as studies that have found

that early experiences with CPAP—that is,

in the first week of use—influence patients’

Diagnosis and Treatment of OSA and CPAP Therapy 371

perceptions. The studies cited in the intro- duction include both older studies and ones written recently (relative to when the study was done), suggesting that the authors were summarizing state-of-the-art knowledge.

The introduction then further advanced the argument for the new study by describing knowledge gaps: “To date, there are relatively

few studies that have systematically examined the influence of disease and treatment percep- tions and beliefs on CPAP adherence.” The authors stated their four interrelated research questions, which were well-suited to an in- depth qualitative approach.

#@ Conceptual Framework

The article devoted a section to a description of the conceptual framework that underpinned the research. The authors used a concep-

tual framework that is widely used in health

behavior research, Bandura’s social cognitive

theory. They authors presented a nice summary of the theory and included a useful conceptual map (Figure 1). They also noted that Bandura’s

model is relevant within a qualitative inquiry because of explicit recognition of the role of

context: “Bandura suggested that the applica- tion of social cognitive theory must be situated

in context, recognizing that ‘human behavior is socially situated, richly contextualized, and

conditionally expressed.’” One puzzling thing, however, is that both in this section and in the

first subsection of the Results, considerable

attention is paid to the role of knowledge in

influencing health behaviors. Yet, knowledge

is not a component of the theory as depicted in

Figure 1.

# Method

The method section was well organized into

four subsections and was unusually rich in detail about how the researchers conducted

the study.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

372 APPENDIX! #

DESIGN

Sawyer and colleagues used a mixed meth- ods design to study patients’ perceptions

and beliefs about OSA and CPAP, and to

explore differences among adherers and

non-adherers. The researchers used termi- nology that was slightly different than that used in the textbook, which is not unusual

because the field of mixed methods research

is evolving. They described their design as a concurrent nested mixed methods design

and provided a citation to a paper by Creswell and Plano-Clark (2003), the two

authors whose more recent terminology

was used in this textbook. (The 2003 paper was probably a recent publication when

the Sawyer et al. study was being planned).

Using the terminology presented in the text-

book, the design would not have a formal,

specific name. Using design terminology

from a 2011 publication by Creswell and

Plano-Clark, the design might be described

as an embedded QUAL (quan) design. Had

Sawyer and colleagues used Morse’s nota-

tion system, they likely would have charac-

terized the study as QUAL + quan, which

indicates that the data for the two strands were collected concurrently,

and that the qualitative component was dominant.

The design section of the report also noted that the design was longitudinal, with data collected both at initial OSA diagnosis

through the first week of CPAP treatment.

Such a longitudinal design is an excellent

way to track patients’ perceptions and

beliefs from diagnosis to the early treatment

phase. The decision about when to collect the two rounds of data was well supported by earlier research. An excellent graphic

(Figure 2) illustrated the study design and the timing of key events in the conduct of

the study, such as enrollment and collection of demographic data, receipt of treatment education, conduct of the diagnostic sleep study and the CPAP sleep study, and the two interviews.

Diagnosis and Treatment of OSA and CPAP Therapy

PARTICIPANTS

The researchers clearly defined the group of interest and described how participants were recruited into the study. Participants

were adults with suspected OSA who were recruited from a Veterans Affairs sleep clinic. To be eligible, patients had to meet various clinical criteria (e.g., had at least moderate OSA, defined as at least 15 apnea or hypo-

pnea events per hour in a sleep study) and practical criteria (had to speak and under- stand English). Patients were excluded if their responses could have been confounded by prior CPAP experiences, because the research-

ers were interested in understanding the perceptions and beliefs early in the diagnosis and CPAP treatment transition.

The researchers also excluded individuals who refused CPAP treatment prior to the

actual treatment, and Figure 2 suggests that

one such person was dropped from the study. That is, 16 patients were interviewed for the pre-treatment interview, but only 15 were

interviewed a second time, and the analysis

was based on responses from 15 patients.

(Sample size issues were discussed in a later section).

One comment about this section is that we

would have described the sampling approach more as convenience sampling than as purpo-

sive sampling. Many qualitative researchers

say that their sampling was purposive when they purposefully select people with the

characteristic or experience that is the focus

of the research. However, we think of these as

eligibility criteria, which need to be identified to ensure that those in the study can provide “expert testimony” about the experience of interest. It would appear that the participants were a convenience sample of those meeting the eligibility criteria, and who were referred by a sleep specialist in one particular clinic.

In our view, the term purposive connotes

conscious and deliberate efforts to sample par- ticular examplars from those who are eligible and who can best meet the conceptual needs of the study. For example, maximum variation

Generating and Assessing Evidence for Nursing Practice (11th ed.)

a APPENDIX| &

sampling is a purposive strategy that involves

a deliberate attempt to select participants who not only meet the eligibility criteria, but who vary along dimensions thought to be important

in understanding the full range of the phenom- enon of interest. In this study, the researchers

could (for example) have deliberately sampled

people with varying degrees of social support, to ensure that this important dimension would have adequate representation. As it turns out, there was variation in social support (marital status) among the study participants, but this

does not appear to have been the result of a purposive strategy. With a small sample, and

with a goal of looking at differences between

adherers and non-adherers, a purposive strategy of sampling patients on dimensions

known to differentiate these groups would have increased the likelihood that both groups

would be adequately represented. In terms of the mixed method design, the

sampling approach for this study would be described as identical sampling. In an iden- tical sample, all study participants provide both qualitative and quantitative data—unlike a nested design, which involves selecting a subset of people from the quantitative strand to provide qualitative information.

PROCEDURES

The section on “Procedures” presented

considerable information, focused primar- ily on data collection. The section began by describing the two sleep studies that all study participants underwent. In both sleep studies, the patient’s Apnea-Hypopnea Index (AHI)

was computed via a polysomnogram. The

initial AHI provided information that helped

to determine study eligibility. Next, the researchers described the major

forms of data collection, which included

semistructured interviews and instrumenta-

tion to assess CPAP adherence objectively. In the subsection on the in-depth interviews, the

article specified that the data were collected by a single investigator at two points in time:

Diagnosis and Treatment of OSA and CPAP Therapy 373

within a week following OSA diagnosis but

before treatment, and then after the first week of treatment. The authors noted that partic- ipants were given choices about where the interviews would take place, in an effort to minimize attrition.

The interview guides were described in

admirable detail. Table 1 listed the questions that guided the initial interview, and Table

2 listed questions for the post-treatment

interview. These tables were an excellent way to communicate the nature of the interviews to readers, and the text provided even more detail. For example, a rationale for using a topic guide was provided (“to ensure that a consistent sequence and set of ques-

tions were addressed across participants”). Consistency was also enhanced by having a

single interviewer responsible for conducting all interviews. To maximize data quality, the interviews were digitally recorded and tran-

scribed by a professional transcriptionist. The interviewer also maintained field

notes before and after each interview.

Commendably, these field notes were not only descriptive (i.e., describing participants and the interview environments), but also “served

as interviewer reflexivity notations (1.e., inter-

viewer biases, suppositions, and presupposi-

tions of the research topic”). An important feature of this study was

that CPAP adherence was not assessed by

self-report. Rather, adherence was objectively

determined based on quantitative data from the CPAP machine. A standard definition of “CPAP use” was provided, and a criterion of 6 hours or more per night of CPAP use was

established for adherence. The researchers provided a convincing rationale for using the 6-hour limit as the cutoff point for adherence

versus non-adherence. One further note is that the researchers

might have considered administering a self-

efficacy scale during the course of their study, to anchor their discussion of self-efficacy, which is a key construct in their conceptual

model. Although many of the major con- structs in the model were ones that merited

Generating and Assessing Evidence for Nursing Practice (11th ed.)

tM SB he

374 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

qualitative exploration, self-efficacy is one that perhaps could have been examined from both a qualitative and quantitative perspec- tive, especially in a study that is explicitly

mixed methods in design.

DATA ANALYSIS

The authors are to be congratulated for their

detailed description of their data analysis methods. Not only did they carefully explain

data analytic procedures in the text, they

also provided an excellent flow chart (Figure 3) illustrating the sequence of steps they followed. It is extremely rare to find such rich

information about data analysis in a qualita-

tive or mixed methods study.

The qualitative data were content ana- lyzed, an approach that is appropriate, given that the study was primarily descriptive. That

is, this study was not designed to shed light on

the lived experience of the patients (phenom- enology), nor on their process of adapting to

CPAP treatment (e.g., in a grounded theory

study). The purpose was to obtain descrip- tive information at two points in time about

participants’ perceptions and beliefs relevant

to OSA and CPAP. The researchers explained

the procedures used in the content analysis

and provided citations for the approach used. In the data analysis section, the researchers

explained how theory-driven themes were extracted in a manner consistent with the broad conceptualization of health behavior

articulated in Bandura’s theory. The authors offered specific illustrations in Table 3, which listed broad theoretical determinants of health behavior in the first column, and then relevant

themes for each determinant as derived from the content analysis. For example, for the

broad construct “Perceived self-efficacy,” there were 5 relevant themes, such as “Fitting

treatment into life” and “Problem-solving difficulties.”

The section on data analysis also included

important information about methods the researchers used to enhance trustworthiness— and these methods were strong. For example,

one investigator coded all the interview

data. Then, an independent expert recoded a randomly selected 15% of the data from each interview. Overall agreement between

the study coder and the expert coder was a

high 94%. For any differences of opinion about coding, the discrepancy was resolved by consensus. The theme definitions used in the coding, which were developed by the investi-

gative team, were reviewed by two experts, a qualitative methodologist and an expert in the application of the theoretical constructs.

Importantly, the qualitative data were coded and content analyzed for themes by an

investigator who was blinded to whether the

participant was classified as adherent or non-

adherent based on the quantitative data. Only after coding was complete was the adherence status of participants revealed. At that point, across-case analysis was examined “from an

integrative perspective, using adherent and

nonadherent as anchors...to identify common

perceptions, beliefs, and experiences within

the groups of interest.” The authors used a meta-matrix, to integrate the qualitative and

quantitative data.

@ Results

The results section began with a description of the study sample; all sample members

were military veterans. Table 4 showed basic descriptive statistics on the demographics of

the 15 participants, including their gender, race/ethnicity, marital and employment status, educational background, and age. Clinical information (e.g., mean weight, AHI events/

hour, and CPAP adherence in terms of hours

per night) was also presented. The text stated

that the sample included six adherers and nine non-adherers. The introductory paragraph of

the results section also noted that data satura- tion was reached at 15 participants, and that

sampling stopped at that point.

Much of the results section was organized

according to differences between adherers and nonadherers to CPAP therapy. The differences

Generating and Assessing Evidence for Nursing Practice (11th ed.)

be APPENDIX | a

were nicely arranged into major thematic

categories, such as “Knowledge and perceived health status,” “Goal setting and outcome

expectancies,” “Facilitators of and barriers to CPAP use,” and “Perceived self-efficacy.” Key differences between the two groups (and a few areas of overlap) within these major groupings were described and supported with

rich excerpts from the interview transcripts. Social support emerged as an important

issue in CPAP adherence, consistent with pre- vious studies. Thus, the researchers performed a useful supplementary analysis in which they

examined differences between married and unmarried patients.

The analysis section concluded with a typology (descriptive profiles) of adherent and nonadherent CPAP users, based on an

integration of the data across themes. Table 5 nicely summarized their typology.

& Discussion

Sawyer and colleagues offered a thoughtful discussion of their findings. Their discussion highlighted ways in which their findings complement and extend the body of evidence on CPAP adherence. The discussion nicely wove together findings from the current study and previous research. It also discussed the

findings within the context of the theoretical

framework. The authors also noted some of the study’s

limitations. They pointed out, for example, that study participants were all veterans with fairly high levels of education, and thus explo- ration with 4 more diverse population of OSA patients would be desirable. The researchers also pointed out that the small sample size of 15 provided limited power for conducting

quantitative analyses of numerical data they

Diagnosis and Treatment of OSA and CPAP Therapy 375

had at their disposal, such as measures of sub- jective sleepiness and functional impairment. They noted that with a larger sample, they could have explored correlations between such quantitative measures and the thematic typology.

Although the discussion is reasonably lengthy, relatively little space was devoted to the implications of the study findings. The

researchers noted that “The described differ- ences between adherers and nonadherers in

our study suggest critical tailored or patient- centered intervention opportunities...”

Indeed, they mentioned the opportunity for

tailored interventions several times in connec- tion with their discussion of the theoretically-

derived themes. A bit more elaboration of how the findings could be used in an interven- tion might have been helpful.

= General Comments

PRESENTATION

This report was clearly written, well orga- nized, and offered an exemplary amount of

detail about the research methods. The inclu- sion of several tables and figures provided readers with explicit and concrete informa- tion about aspects of the study that are often ignored or described in a single sentence. We applaud the authors, and we also applaud the journal, Qualitative Health Research, for not

having strict page limits.' The need for page

limits is understandable given the explosion of research that is being undertaken. However, the ability for readers to judge the quality of research evidence is also crucial, and

this is sometimes hampered by constraints on researchers’ ability to provide thorough

information about how the research was

conducted.

'The QHR guidelines to authors that were is effect state the journal’s page limit policy as follows:

“There is no predetermined word or page limit. Provided they are ‘tight’ and concise, without unneces-

sary repetition and/or irrelevant data, manuscripts should be as long as they need to be.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

376 APPENDIX! ® Diagnosis and Treatment of OSA and CPAP Therapy

ETHICAL ASPECTS

The authors briefly stated steps they took to ensure ethical treatment of participants

in the subsection labeled “Participants.” All participants provided informed consent, and

the study protocols were approved by the Institutional Review Boards of the affiliated university and the research site.

@ Response From the

Sawyer Team .

Dr. Sawyer and her colleagues were asked

if they wished to comment on this critique.

Dr. Sawyer remarked that she was “in near

100% agreement with the draft critique that you provided” and that there was nothing she felt she needed to rebut. Given the generally positive nature of the critique, Dr. Sawyer

noted that, “I don’t know that I have much in

the way of response to offer -- however, the

suggestion to include a self-efficacy instru-

ment is ‘spot on’.”

Her email concluded with the following statement: “My study colleagues and I are

very pleased with the published paper in QHR and firmly believe the paper is an excellent teaching resource for mixed methods research in health and disease.” We agree.

APPENDIX J

THE CANCER Worry SCALE REVISED FOR BREAST CANCER

GENETIC COUNSELING Anita Caruso e¢ Cristina Vigna

> Background: The Cancer Worry Scale was revised

to be used In breast cancer genetic counseling

(CWS-GC). This scale is used to identify dimensions

that are relevant in the genetic counseling context,

such as worry about developing breast cancer,

impact of worries on daily life, and risk perception

in women attending a counseling session for

BRCA1/2 mutations.

& Objective: The aim of this study was to estimate

the psychometric properties of the CWS-GC ina

sample of Italian women.

> Methods: A total of 304 women aged 19 to 90

years, 58% with history and 42% with no history of

breast or ovarian cancer, participated in the study.

Validity, reliability, and sensitivity to change of the

CWS-GC were assessed. > Results: Confirmatory factor analysis suggested a

2-factor structure of the CWS-GC measuring cancer

worry and risk perception and with Cronbach's a

coefficients of .90 and .70, respectively. Crite-

rion validity was attested by substantial yet not

overlapping correlations with anxiety and fear of

medical procedures. In a subsample of 50 women,

test-retest reliability at a 4-week interval ranged

from 0.70 to 0.87, and the CWS-GC was able to

detect small to medium changes 1 month after

genetic counseling.

> Conclusions: Overall, the CWS-GC showed good

psychometric characteristics in this population.

> Implications for Practice: The CWS-GC would be appropriate for use by healthcare professionals

to better understand how women react and adapt

to information on genetic cancer risk to provide

Paola Gremigni

them with emotional support and encourage

surveillance behaviors.

> Key Words: BRCA|1 - BRCA2 - Cancer worry -

Cancer worry scale - Genetic counseling -

Risk perception

Genetic predisposition is estimated to account for 5% to 10% of the breast cancer cases that

are diagnosed each year, and approximately one-third of these cases are attributable to mutations in BRCA1 or BRCA2 genes.' In

BRCA1/2 mutation carriers, the overall breast

cancer risk by the age of 7Oyears is 51% to

59%, and the overall ovarian cancer risk is

11% to 34%.” An overall BRCA1/2 mutation

prevalence of 13.7% to 41.9% was observed in persons with a family history of breast/

ovarian cancer, which varies depending on the number of family members affected.? Genetic testing provides an opportunity to

enhance health promotion and longterm health

outcomes by identifying at-risk individuals before cancer develops.* Provision of genetic counseling to women with a family history

of breast/ovarian cancer indeed aims to help them understand and process the information received about their genetic risk. To achieve these objectives, we should examine those vari-

ables that are closely related to health-oriented

behaviors in cancer genetic counseling. Many social factors have been linked

to health-oriented behaviors including

Reprinted with permission from Caruso, A., Vigna, C., and Gremigni, P. (2018). The Cancer Worry Scale ST,

revised for breast cancer genetic counseling. Cancer Nursing, 47(4), 311-319.

bt Jeo

378 APPENDIXJ ™ The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

sociodemographic variables’; however, only

modifiable factors may help planning effective interventions. The most researched variables in this field are cancer worry (CW) and per-

ception of risk®” for several reasons: they are

amenable to change and offer an opportunity to intervene’; women with a family history of

breast cancer report elevated CW’; perceived breast cancer risk, which is often overesti-

mated, is a stronger predictor of breast CW’; and both variables are highly associated with

health behaviors, such as decision to undergo genetic testing, adherence to screeningymam-

mogram, and choices about prophylactic surgery.>10-!4

Although risk and worry have been

frequently used interchangeably,’ they are

conceptually different. In fact, risk percep- tion (RP) is a cognitive dimension that refers

to one’s belief about the likelihood that an adverse event, such as cancer, occurs.'° Cancer worry is instead an emotional

reaction to the threat of cancer.'® Cognitive (risk) and affective (worry) perceptions of

vulnerability have a central role in self-

regulation and may interact in determining

health behaviors according to various health behavior theories and models.!’ Therefore,

it is important to investigate both RP and worry, but it is also important to distinguish

between the two because they may influence

behavior differently.'* Indeed, RP and worry

have been described as driving behaviors in parallel,'® or interacting in determining

behavior,'* and were found to be modestly

related.'” For example, CW was found to

predict interest in genetic testing’ and breast

cancer screening”’ even after controlling for perceived risk.

PREVIOUS MEASURES

Researchers have used a variety of measures

to assess breast cancer-related worries”!

including generally standardized question-

naires such as the revised Impact of Event Scale and Spielberger State Anxiety Scale; however, purposely designed scales are

preferable in terms of the precise source of anxiety they target.’ One of the earlier breast CW scales was developed by Lerman and her colleagues””: the Cancer Worry Scale (CWS).

This is a 4-item scale that measures the

current level of worrying about getting breast cancer, the impact of worry on mood and performing daily activities, and worry about

future mammographic results. Although other specific measures have been also developed, such as the Cancer Attitude Inventory,” the

Breast Cancer Fear Scale,* and the Cancer

Worry Chart,” the CWS still remains the

most used tool, with approximately 400 studies across more than 10 countries show-

ing good psychometric properties, such as Cronbach’s a in the range of .82 to .86.7%7 The advantage of CWS as compared with other similar instruments is that it measures

both CW and impact of worry. Instead, the

Cancer Attitude Inventory measures atti-

tudes, the Breast Cancer Fear Scale measures

fear and physiological arousal, and all these

dimensions are different from the worry

construct. The Cancer Worry Chart is a single pictograph item, which measures how much a person has been bothered by thoughts or wor- ries about the chance of getting breast cancer and was tested for comparative validity using

the CWS as the criterion standard measure.

In the years, researchers have adapted the

CWS to the specific needs of their studies on breast and other cancers.'°7!78?

Most studies using the CWS considered it a unidimensional measure.”°*? However, we

observed in Italy that it was formed by items that could identify 2 clearly related but poten-

tially distinguishable concepts: the presence of thoughts and concerns about developing cancer and how these concerns may impact on or interfere with one’s mood and daily life. In the original study, Lerman et al’? summed the 2 worry impact items to create a worry

impact index as a separate variable because

these items do not ask about experiencing worry per se. The importance of distinguish- ing between these 2 concepts also emerges from a study of women at a high risk for

breast cancer.*? Two-thirds of the respondents

APPRENDIXJ

perceived worries about breast cancer as

interfering with their daily functioning, whereas one third did not. In addition, the

impact of worry predicted anxiety, confusion, and a reduced mental health after the effects of other variables such as the frequency of CWand having a family history of cancer.*°

In the literature, the assessment of RP has

been carried out through a variety of nonval-

idated measures such as a numerical rating scale of 0% to 100%,*' with 100 representing the highest risk, or descriptive scales with

Likert-type response format (eg, ranging from “not at all likely” to “extremely likely”).°?

However, there is evidence that the numerical

rating scale has the best performance based on several criteria, such as being predictive of health-oriented behaviors, correlating with

similar measures, and being associated with

the actual risk.> Within cancer genetic coun-

seling, the perception of risk is understood as the likelihood to be a carrier of a genetic

mutation such as the BRCA1/2 (genetic RP [GRP])'° and, consequently, the probability

of developing cancer (cancer RP [CRP]).°? A

previous Italian study'! assessed both GRP and CRP with 2 items answered on a scale of 0% to 100%.

AIM

This study aimed to validate a revised form

of the CWS" to assess both breast CW and RP of being positive to BRCA1/2 or develop-

ing breast cancer in women attending cancer

genetic counseling in Italy. We hypothesized

that this tool could be formed by 2 indepen- dent indexes measuring CW and CRP/GRP, respectively. We also hypothesized that CW

consists of 2 highly interrelated but distinct dimensions: the frequency/intensity of CW

and the impact of CW on mood and daily

functioning. To be useful for clinical practice and

research, this measure should be feasible to

administer in clinics and have sound psycho- metric attributes, including validity, reliabil-

ity, and sensitivity to change.

Reprinted

with permission.

The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling 379

& Methods

STUDY DESIGN

This is a cross-sectional multicenter study

conducted across Italy and approved by the

ethics committees of the 7 participating hospi-

tals. The study design was based on 3 steps. In step 1, a pool of items was selected

from existent tools, forward-backward

translated using a standard procedure, and then piloted in a small group of patients. Two bilinguals translated the original items

into Italian, and 2 independent translators back-translated it into English. An indepen- dent translator, who was a native speaker of the target language and fluent in the source

language, was used to carry out the reconcil- iation, and minor differences were corrected

at this stage. Participants in the pilot study filled in the self-report questionnaire and

then were asked to provide feedback regard- ing the clarity of each item and any addi-

tional comments.

In step 2, the questionnaire was adminis- tered to a larger sample of participants, along

with measures of potentially associated vari- ables, to assess structural validity, criterion

validity, and internal consistency. To assess criterion validity, we used standard measures of fear of medical procedures, anxiety, and

depression. We expected high correlations of CW with fear of medical procedures and with anxiety because worry, anxiety, and

fear are all emotional states characterized by

hyperarousal, although they refer to differ- ent constructs. In fact, it has been suggested

that cancer fear refers to a rating range that

may be dysfunctional in the upper extreme and CW refers to a lower, more manageable

range of the affect.’ Anxiety is a more general

emotional condition that was found to be highly associated but not overlapping with

CW, which was therefore clearly identifiable

from anxiety.’ We also expected higher correlations with anxiety and fear of medi- cal procedure than with depression because

depression is a mood condition characterized

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

soy,

380 APPENDIXJ ™ The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

instead by hypoarousal. We expected signifi- cant but lower associations between RP and

mood disturbance (anxiety, fear of medical

procedure, and depression) because they are

cognitive and emotional perceptions, respec-

tively. We also used group comparisons to

evaluate the extent to which the scale was able to discriminate between subgroups of

patients with different current symptoms (ie, asymptomatic vs symptomatic). We expected

that women who had experienced cancer

perceived a higher CW than asymptomatic

women.*° On the contrary, we expected that

potentially asymptomatic mutation carriers perceived less controllability of their condi- tion than women with manifest disease and

then reported a lower RP. However, this

analysis was explorative because results of the literature are controversial.°°°”

In step 3, the questionnaire was adminis-

tered again after approximately 1 month to

a subsample of participants to assess both test-retest reliability and sensitivity to change. Patients were expected to have CW reduced 1 month after a genetic counseling informative session.*”

In steps 1 and 2, the consenting patients

completed the questionnaire immediately before genetic consultation; in step 3, participants com-

pleted a 4-week follow-up at the same genetic clinic. Each participant signed informed consent

to the study, and data were handled in accor-

dance with the Italian privacy law.

PARTICIPANTS

Volunteer patients for the pilot study were

recruited in 2 of the 7 participant hospitals. This was a convenience sample formed by

patients with similar characteristics to those of the instrument audience, yet not strictly

representative of the study population. Indeed, we gave preference to patients who read at or lower than the eighth grade level because concepts such as genetic testing and RP are highly complex. This complexity could be a major barrier to comprehension for

adults with low literacy skills, who have been

Generating and Assessing Evidence for Nursing Practice (11th ed.)

found to provide answers on self-reports to questions that they do not completely under- stand.* The main purpose of the pilot study was to ensure readability, absence of ambigu-

ity, and understanding of scaling and content of the questionnaire and not to make the results of the pilot study directly generalizable to the ultimate study. A practical rule is that a simple and clear tool that is appropriate for

persons with limited literacy is also suitable for those with well-developed literacy.*’

The main study sample was recruited at the 7 cancer genetic clinics participating in the

study. The required sample size was estimated

a priori based on confirmatory factor analysis (CFA) model identification, as described

hereinafter in the Data Analysis section. All

self-referred eligible women attending a first visit for genetic counseling were informed

about and invited to participate in the study. Eligible participants were women 18 years

or older having at least 1 first-degree relative with breast and/or ovarian cancer and/or

who were members of families that had not been previously tested for BRCA1/2 mutation

and had not attended any genetic counseling

session. The study sample included asymp-

tomatic women with no personal history of

cancer, as well as affected women, because

inherited susceptibility has implications for the risk of cancer recurrence. Care was also

taken to ensure that unaffected women were not waiting for the results of cancer screening. Although the study focus is on breast cancer,

participants attending cancer genetic clinics

may have ovarian cancer or relatives with ovarian cancer because BRCA1/2 mutation

predisposes to both types of cancer.

To form the subsample participating in the 4-week follow-up, 5 of the 7 hospitals ran- domly selected 10 patients among those who completed the first wave survey. Estimates of the minimum sample size required for test-

retest reliability, at the conventional values

a of .05 and B of 0.20, for reliability values

of 70% or higher and 2 replications include approximately 41 subjects.*? However, 50

subjects were selected to handle potential nonresponse to the follow-up.

Reprinted

with permission.

APPENDIXJ #

MEASURES

Demographic and medical characteristics included age, educational level, information

on previous diagnosis of cancer and treat- ments made, and the number of first-degree

relatives affected by breast, ovarian, or other cancers.

CWS for Genetic Counseling. The CWS

for Genetic Counseling (CWS-GC) measures

anxiety that is specific to getting breast

cancer and CRP/GRP. It is formed by the

original CWS,”* which includes 4 items measuring the intensity of worry about

developing breast cancer, anxiety for future mammograms, and impact of breast CW on

mood and daily functioning, answered using a 5-point scale (from 0, “not at all/never,” to 4, “very much/very often”). We added 1 item on the frequency of worries about developing breast cancer taken from one of the numer-

ous revised versions of the CWS?* because we considered frequency an important aspect

within the global level of CW. We com-

pleted this tool adding 2 items to measure, respectively, the perceived risk of having an

altered breast cancer gene’? and of develop- ing breast cancer.” In this way, we obtained

a brief tool to assess both cancer worries and perceived risk, although measured with different response formats. Indeed, the last 2

items were rated using a visual analog scale ranging from “no perceived risk” (0%) to

“the highest perceived risk” (100%) because

this format showed the best performance with perceived risk questionnaires.*? We did

not expect that different response formats may affect the results of the CFA because multiple-group invariance was found across

different response formats, differing in the type of anchor points using horizontal rating

scales.*! An Italian version of the items used to

form the CWS-GC was made and then revised, pretested, again revised, and subse-

quently approved to be used in this study. Items of the CWS-GC are shown in the

Appendix.

Reprinted

with permission.

The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling 381

State-Trait Anxiety Inventory. The State-Trait Anxiety Inventory (STAI) is a well-validated questionnaire that measures general anxiety.” The trait 20-item scale asks participants to indicate, on a 4-point scale,

how they generally feel regarding 20 state-

ments, whereas the state 20-item scale asks

participants to describe how they currently feel regarding the same 20 statements. Total scores for each scale range from 20 to 80. A

higher score of the trait scale indicates a gen-

eral negative affectivity, and a higher score of the state scale indicates higher state anxiety.

Cognitive Behavioral Assessment-Form H.

The Cognitive Behavioral Assessment-Form H*? is an Italian well-established battery of

tests that provides a comprehensive clinical

assessment. Three of the included scales were

used in this study: Al (9 items) measures a gen-

eral state of anxiety, A2 (5 items) assesses fear

reactions to situations related to health man-

agement and diagnostic/curative treatments or medical procedures, and A3 (5 items) investi-

gates the presence of depressive thoughts. Items are answered with true/false.

DATA ANALYSIS

Scores obtained from 5 of the 7 CWS-GC items were rescaled to a 0 to 100 basis to

facilitate their manipulations according to percentage of scale maximum scores [%SM =

(score) x 100/(number of scale points — 1)].

To allow considering the main sample as

homogeneous, although 7 different institutions contributed patients, similarity was preliminary investigated among subsample characteristics

and scores of measures. Comparisons were

computed using analysis of variance (ANOVA) at item level for the CWS-GC and at scale level

for the other measures. Confirmatory factor analysis was used to

examine the extent to which the CWS-GC items can be-combined into the 3 hypothe- sized multi-item scales referring to frequency/ intensity of CW, worry impact, and CRP/ GRP, respectively. The proposed 3-factor

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

382 APPENDIXJ #

model was compared with a 1-factor model

to exclude that the scale was best represented

as a single dimension. It was also compared with a 2-factor model, one formed by the

items related to CW and the other formed by

the items related to perceived risk. The robust maximum likelihood method was used to estimate model parameters: Satorra-Bentler

scaled y* statistic (S-B y’),** root mean square error of approximation (<0.08),*° standard- ized root mean square residual (<0.08),*

nonnormative fit index (20.95),*° and com-

parative fit index (>0.95).*° The previously mentioned indices were examined for the

3 tested models, whose goodness of fit was

compared by an S-B x’ difference test with the

correction needed when the S-B scaled y? is

used.** To establish the minimum required sample

size for CFA model identification, focusing

our interest only on obtaining an adequate

sample size to estimate the factor loadings,

we conducted a Monte Carlo simulation following the guidelines described by Muthén

and Muthén.*” We used a 3-factor model

indicated by 2 or 3 indicators, with standard-

ized factor loadings of 0.50 and less than 2%

missing data per indicator, because it was

more demanding than a 2- or 1-factor model.

The minimum required sample size was approximately 290.

The internal consistency of scales was

assessed by Cronbach’s a coefficient, whose

desirable value is .70 or greater.*® As evidence of criterion validity, zero-order

correlations were calculated between the

CWS-GC and criteria (ie, STAI and Cognitive

Behavioral Assessment-Form H scales), and

ANOVA was used to evaluate whether the

CWS-GC was able to discriminate between

asymptomatic and symptomatic women. Intraclass correlation was used to provide

an estimate of the questionnaire test-retest

reliability at 4 weeks using a subsample of patients, with a value greater than 0.70 as acceptable. These 2 administrations of the CWS-GC were also used to examine the sen-

sitivity of the questionnaire to change using repeated-measures ANOVA.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

In the evaluation of estimates, we based

conclusions on both statistical significance (P

< .05) and standardized measures of effect,

with Cohen d of 0.2 considered small, 0.5

considered medium, and 0.8 considered large and Pearson r of 0.10 considered small, 0.30

considered medium, and 0.50 considered

large.*” Cohen d was corrected, where appro-

priate, for dependence between means using Morris and DeShon’s*? equation8.

Confirmatory factor analyses were per-

formed using LISREL 880 (Scientific Software International, Lincolnwood, Illinois); all other

analyses were performed with IBMSPSS 20

(SPSS Inc, Chicago, Illinois).

@ Results

PARTICIPANTS’ CHARACTERISTICS

Participants in the pilot study were 25 women

aged from 45 to 75 years. Most of them (64%) had an eighth grade level of education,

and two-thirds (64%) had a history of previ-

ous breast or ovarian cancer. Participants in the main study were

304 women aged from 23 to 83 years.

Approximately 58% were given a diagnosis of

or treated for breast or ovarian cancer. There

were no statistically significant differences in the characteristics of patients from the 7 hospitals.

The subsample participating in the 4-week follow-up was formed by 50 women. This subsample has characteristics that are compa-

rable with those of the ntire sample, except

for a larger proportion of women affected by cancer (Table 1).

The Pilot Study. Sixty percent of the par- ticipants in the pilot study reported having spent 10 to 15 minutes to complete the test,

whereas 32% reported having spent less than 10 minutes. Eight participants (32%)

found an item (“What do you think are the odds that you have mutations in BRCA1/2

genes?”) difficult to understand, and thus,

Reprinted

with permission.

APPENDIXJ ™& The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling 383

Table 1 Participant Characteristics —— re ee

Sample (n = 304) Retest Subsample (n = 50)

Age, mean (SD) (range), y 46.85 (11.9) (19-90) 45.96 (8.69) (26-66)

Level of education, n (%)

Lower secondary 63 (20.7) 9 (18)

Higher secondary 145 (47.7) 24 (48)

Tertiary 96 (31.6) 17 (34)

Cancer affected, n (%) 176 (57.9) 39 (78)

Breast cancer 162 (92) 38 (97.4)

Ovarian or other cancer 14 (8) 1 (2.6)

it was reformulated until it was deemed completely understandable (“How likely is

that you have one of the genes for predispo- sition to breast cancer altered?”). The other

items were all rated clear and understandable.

Overall, the CWS-GC was found by patients

to be quick and simple to complete. We exam-

ined response sets because they may lower

the validity of a test. Response errors and item nonresponses were not found. Extreme

responding, which is a form of response

bias driving respondents to only select the

most extreme answers available, that was

previously found in low-educated people*®

was observed in only 2 of 25 respondents

(8%). As regards item discrimination, the discrimination index D was computed from equal-sized high- and low-scoring groups on the test, with D values of 0.40 and greater regarded as high.*! All items of the CWS-GC showed adequate discrimination both on high

scores (D between 0.57 and 0.86) and low

scores (D between 0.50 and 0.86).

Validity and Internal Consistency.

Comparisons among patients from different institutions showed no significant differences on scores of all the measures; therefore, we

considered the main sample as a whole. In the CFA 1-factor model, none of the

indices met its respective criterion, indicating

that a model with a single latent variable was

not a good representation of the CWS-GC

Reprinted

with permission.

structure (Table 2). The 2-factor model (Table

2, Figure 1) provided a significantly better fit to the data, although ’ values were still signifi- cant. The 3-factor model (Table 2, Figure 2)

showed a better fit with a significant improve- ment in x fit compared with the 2-factor

model. However, the correlation between

CW and worry impact was extremely high (r

= 0.94) supporting the concept of a unitary

global score. In general, a second-order factor can be postulated behind highly correlated fac- tors, but it should be taken into consideration

in the consequential multicollinearity if these

factors are used in further analyses with other variables. To make a final decision regarding the model to choose, we evaluated the discrimi-

nant validity of each factor and compared

it among the 3- and 2-factor solutions.” Discriminant validity is satisfied when a latent

variable is able to account for more variance in the observed variables associated with it

than the amount of variance shared with other

factors within the conceptual framework. Results indicated that, in the 3-factor solution,

there was a questionable discriminant validity

for CW and worry impact because the average

variance extracted by these 2 factors (0.88 and 0.81, respectively) was not larger than the amount of variance shared between the two (y

= 0.88). Instead, in the 2-factor model, average

variance extracted values were 0.89 for CW and 0.59 for RP, which were both larger than

their shared variance (y” = 0.49). On the basis

Generating and Assessing Evidence for Nursing Practice (11th ed.)

384 APPENDIXJ ™® The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

Table 2 Confirmatory Factor Analysis’ Goodness-of-Fit Indices for 3 Models of the CWS-GC

Fit Indices 1-Factor Model 2-Factor Model 3-Factor Model

x? (df) 83.74 (14)? 34.48 (13)? 15.78 (11)

S-B 2 (df) 78.96 (14)? So 42A(3)2 16.14 (11)

AS-B x? (Adf)> - 24.84 (1)? 14.09 (2)?

RMSEA (90% Cl) 0.13 (0.10-0.15) 0.07 (0.06—0.10) 0.04 (0.00-0.08)

SRMR 0.06 0.03 0.02

NNFI 0.95 0.98 0.99

CFI 0.96 0.99 1.00

Abbreviations: CFI, comparative fit index; CI, confidence interval; NNFI, nonnormative fit index; RMSEA, root mean

square error of approximation; S-B y’, Satorra-Bentler scaled x’ statistic; SRMR, standardized root mean square

residual. IP KOOL

>AS-B index was calculated between 2- and 1-factor models and between 3- and 2-factor models, respectively.

of consideration of discriminant validity, the intercorrelations among these factors con-

2-factor model was chosen for the CWS-GC, firmed that they are linked but not overlapping

although it led to some decrement in model concepts.*!4° Mean (SD) values are presented fit. Standardized factor loadings for this model in Table 3.

were higher than 0.55 (P < .001). The 2 factors In the whole sample, the CW scale cor-

were named CW and RP, respectively. The related substantially but not overlapping

SS =)

= “A

g 5 cS

° =. & Co «- Bis

a we

70 Impact on 42 activities

.60 ; 97 Cancer

Risk Fe Perception : 70

Mutation

Figure 1. Two-factor model of the CWS-GC.

APPRENDIXJ & The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling 385

Risk Perception

-76

-78

P25

Cancer

20 Mammography

Frequency

Figure 2. Three-factor model of the CWS-GC.

(r in the 0.51-0.60 range) with state and

trait anxiety and medical fears, whereas

they correlated moderately (r = 0.34) with

depression. The RP scale showed small to

medium correlations with criterion variables

(Table 3). Correlations with age were negli-

sible(7= 0. llr = .06, for ews 7 =—0710,

P = .07, for RP).

Group differences were statistically

significant only in RP, although with a small effect size, with patients affected by cancer

-70

reporting a lower perceived risk than women

with no cancer history (Table 4).

Internal consistency of the CWS-GCwas

good to acceptable, with Cronbach’s a coefficients of .90 for CW and .70 for RP.

Corrected item-total correlations for each

subscale were in the range of 0.50 to 0.72.

Test-Retest Reliability and Sensitivity to

Change. Test-retest stability for a 4-week

period in a subsample of patients (n = 50) was

Table 3 Descriptive Data and Correlations Among Study Variables (N = 304)

Mean (SD)

CW ; 38.55 (23.44)

RP 49.16 (21.62)

STAI-T 42.17 (10.35)

STAI-S 44.63 (12.48)

Al 3.29 (3.14)

A2 2.19 (1.30)

A3 0.47 (0.85)

Min-Max

0-100

20-80

0-9

0-5

Pearson Correlations

0.28

0.38

0.33

0.28

0.20

Abbreviations: A1, general anxiety; A2, fear of medical procedures; A3, depression; CW, cancer worry; RP, risk per-

ception; STAI-S, anxiety state; STAI-T, anxiety trait.

All correlations are significant at the P < .001 level.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.) with permission.

386 APPENDIXJ # The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

Table 4 Descriptive Data and Differences Among Health Conditions (N = 304) ED

Variable Condition Mean (SD) F P d

CW No cancer (n = 128) 36.21 (22.76) . DA 14 OM,

Cancer (n = 176) 40.26 (23.84)

RP No cancer (n = 128) 52.06 (20.56) 3.99 .04 0.24

Cancer (n = 176) 46.99 (21.62)

Abbreviations: CW, cancer worry; d, Cohen d value; RP, risk perception.

acceptable, with intraclass correlation values

of 0.87 (95% confidence interval, 0.78-0.93)

for CW and 0.70 (95% confidence interval,

0.41-0.81) for PR. As regards sensitivity to change, the

CWS-GC scales were able to detect changes in CW that were statistically significant, with a medium effect size among patients with can-

cer and a large effect size among patients with no cancer. In RP, change was significant and

of a medium effect size among patients with no cancer and of a small effect size among patients with cancer (Table 5).

@ Discussion

Genetic cancer risk assessment has been

increasingly incorporated into clinical care,

but planning supportive care for women seek-

ing genetic counseling requires knowledge of their health beliefs and emotional reactions.

Cancer worries and RP play an important role in psychological reactions and adapta- tion to the information received, as well as in

promoting surveillance behaviors that help minimize the risk of developing cancer.*!*"8

Therefore, precounseling RP and CW should be routinely assessed for new referrals to genetic counseling clinics.

In this study, we tested, in a sample of Italian women with a family history of breast/ ovarian cancer attending a screening for

BRCA1 or BRCA2 mutations, the psycho- metric properties of a brief tool where these

2 constructs are integrated. We added to the

CWS,” a measure of cancer worries widely

used at an international level, 2 items on per- ceived risk of having an altered breast cancer

gene and developing breast cancer, respec-

tively. Previous studies**”’ used exploratory

factor analysis to test the dimensionality of CWS in different countries, whereas items

related to cancer RP have not been validated,

although they have been previously used in

Table 5 Descriptive Data and Sensitivity to Change Analysis (N = 50)

Pretest Follow-up

Variable Condition Mean (SD) Mean (SD) P d

CW No cancer (n = 11) 43.18 (31.76) 28.41 (20.48) .02 1.15

Cancer (n = 39) 43.91 (25.38) 34.40 (19.25) .001 0.67

Total (n = 50) 43.75 (26.56) 33.08 (19.47) .001 0.75

RP No cancer (n = 11) 62.27 (23.24) 48.72 (25.17) .05 0.64

Cancer (n = 39) 51.68 (22.16) 49.65 (21.13) 56 0.09

Total (n = 50) 54.01 (22.60) 49.45 (21.04) .04 0.21

Abbreviations: CW, cancer worry; d, Cohen d value; P, P value of ANOVA within groups; RP, risk perception. Within-condition interaction was nonsignificant in all cases (P>.05).

APPENDIXJ #&

different countries.'°** Therefore, this tool

was intended to be used also in countries other than Italy for all women undergoing

genetic susceptibility testing for BRCA1/2. This is the first study that validates a tool measuring both breast CW and RP using CFA, which offers greater modeling flexibility

than exploratory factor analysis and allows comparing different models for the factor structure of a tool. On the basis of the results of CFA and discriminant validity, a 2-factor

model was chosen for the CWS-GC, which

showed acceptable internal consistency and test-retest reliability for a 4-week period. This structure, based on CW and RP, may add

more information to the CWS because previ- ous research has shown that high perceived risk of breast cancer may result in high levels

of CW.°> On the other hand, CW was related

to preventive health behaviors, such as cancer

screening’ or interest in genetic testing.’

The CWS-GC showed correlations of CW with anxiety and medical fears that were

higher than those with depression, as in a previous study,*® attesting that the question-

naire is sensitive in detecting specific concerns

related to the situation rather than measur- ing a general state of negative affectivity. In addition, the scale was able to detect changes

that were statistically significant. The decrease of CWS-GC score after the genetic counsel- ing session confirmed the results of previous

studies showing a reduction on both CW

and perceived risk after a genetic counseling informative session.*”

Group differences were statistically signif- icant in perceived risk, although with a small effect size, with patients affected by cancer

reporting a lower perceived risk than women with no cancer history. Findings from the lit- erature are controversial about this issue. For example, women who had already had breast/ ovarian cancer showed raised perceptions of

risk in comparison with nonaffected women in a study,*° but unaffected women believed

that they were at a higher risk for breast can- cer than affected women in another study.°” Results from the literature also indicated that women who had already had breast/

Reprinted

with permission.

The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling 387

ovarian cancer showed more concerns about cancer than nonaffected women,*° whereas in

this study, there was no difference between

groups. Therefore, there is a need for further investigation regarding the differences in both

CW and perceived risk between nonaffected and affected women.

LIMITATIONS

Our study has some limitations. First, its prevalent crosssectional nature did not

allow examining longitudinally all partici-

pants’ experiences, which may change over time. Nevertheless, we may expect that the

CWS-GC is suitable for evaluating changes occurring in the course of the genetic counsel- ing process because it showed in the subsa- mple of patients reevaluated at 4 weeks after

genetic counseling. Second, the predictive validity of the scale on health behaviors, such

as adherence to surveillance programs, still remains to be explored.

IMPLICATIONS FOR PRACTICE

The 7-item CWS-GC is reliable, valid, and

short enough to avoid burden to the patient. At the same time, it makes possible for

nurses to screen women attending breast cancer genetic counseling for overestimated RP and severe levels of CW and assist them in accessing available support. Recognizing

when patients are experiencing breast CW has

been indeed considered an essential first step

toward patient-centered counseling.” The

CWS-GC would be very appropriate for use to better understand how women react and adapt to information on genetic risk and the

results of genetic testing. It can also help iden-

tify those women who are more vulnerable to

developing anxiety and depression, which are both associated with CW,*° because women

undergoing genetic susceptibility testing for BRCA1/2 reported increased long-term

psychological distress, in terms of anxiety and

depression, that warrants clinical attention.”

Generating and Assessing Evidence for Nursing Practice (11th ed.)

388 APPENDIXJ

At a more general level, this understand- ing is necessary to implement effective intervention protocols to prevent counseling

dropout and facilitate surveillance behav- iors. Moreover, this brief and reliable tool

could be adapted for other contexts. For

example, a modification of the CWS has been recently adapted to detect fear of can- cer recurrence in breast cancer survivors,”

and thus, it could be adapted and applied

in genetic counseling for diseases other than

breast cancer.

ACKNOWLEDGMENTS

We thank all psychologists belonging

to the Psycho-oncology Committee on Psychological Aspects of Onco-Genetic

Counseling for participation in the study: Antonietta Annunziata, Oncological Referral

Center, Aviano; Claudia Borreani, Cancer

Institute, Milano; Eleonora Capovilla,

Veneto Oncology Institute, Padova;

Caterina Condello, University Hospital

“Federico II,” Napoli; Anna Costantini,

“Sant’Andrea” Hospital, Roma; Gabriella

De Benedetta, National Cancer Institute,

Pascale Foundation, Napoli; Francesca Lupo,

European Oncology Institute, Milano; Elena Meggiolaro, Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), Forli; Gabriella Morasso, Cancer

Institute, Genova; Chiara Iridile, Hospital

Agency “C. Poma,” Mantova; Elisabetta Razzaboni, Oncology Center, Modena, and

“Sant’Orsola-Malpighi” Policlinic, Bologna;

and Samantha Serpentini, University

Hospital “Santa Maria della Misericordia,” Udine. We also thank Giulia Casu for help- ing with the data analysis.

Correspondence: Anita Caruso, PsyD, Regina Elena National Cancer Institute, Via Elio Chianesi 53,

00144 Rome, Italy ([email protected]).

Author Affiliations: Regina Elena National Cancer

Institute, Rome (Drs Caruso and Vigna); and

Department of Psychology, University of

Bologna (Dr Gremigni), Italy.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

The authors have no funding or conflicts of interest

to disclose. Accepted for publication March 28, 2017. DOI: 10.1097/NCC.0000000000000S 11

REFERENCES 1. Ford D, Easton DF. The genetics of breast and

ovarian cancer. Br J Cancer. 1995;72(4):805—812.

2. Rebbeck TR, Mitra N, Wan F, et al. Association

of type and location of BRCA1 and BRCA2 mutations with risk of breast and ovarian cancer. JAMA. 2015;313(13):1347-1361.

3. Kast K, Rhiem K, Wappenschmidt B, et al. Prev- alence of BRCA1/2 germline mutations in 21/401 families with breast and ovarian cancer. ] Med Genet. 2016353(7):465-471.

4. Calzone KA, Biesecker BB. Genetic test-

ing for cancer predisposition. Cancer Nurs.

2002;25(1):15-25. 5. Consedine NS, Magai C, Krivoshekova YS, et al.

Fear, anxiety, worry, and breast cancer screening behavior: a critical review. Cancer Epidemiol Biomarkers Prev. 2004;13(4):501-510.

6. Lipkus IM, Kuchibhatla M, McBride CM,

et al. Relationships among breast cancer perceived absolute risk, comparative risk, and worries. Cancer Epidemiol Biomarkers Prev. 2000;9(9):973-975.

7. Cameron LD, Diefenbach MA. Responses to information about psychosocial consequences of genetic testing for breast cancer susceptibility: influences of cancer worry and risk perceptions. J Health Psychol. 2001;6(1):47-59.

8. Cohen M. Breast cancer early detection, health beliefs, and cancer worries in randomly selected women with and without a family history of breast cancer. Psychooncology. 2006;15(10):873-883.

9. McGregor BA, Bowen DJ, Ankerst DP, Ander- sen MR, Yasui Y, McTiernan A. Optimism, per- ceived risk of breast cancer, and cancer worry among a community-based sample of women. Health Psychol. 2004:23(4):339-344.

10. Helmes AW, Bowen DJ, Bowden R, et al. Pre- dictors of participation in genetic research in a primary care physician network. Cancer Epidemiol Biomarkers Prev. 2000;9(12):1377-1379.

11. Caruso A, Vigna C, Maggi G, Sega FM,

Cognetti F, Savarese A. The withdrawal from oncogenetic counselling and testing for hered- itary and familial breast and ovarian cancer. A descriptive study of an Italian sample. J Exp Clin Cancer Res. 2008;27:75.

12. Hay JL, Buckley TR, Ostroff JS. The role of cancer worry in cancer screening: a theoretical and empirical review of the literature. Psychooncology. 2005;14(7):517-534.

Reprinted

with permission.

APPENDIXJ &

14.

iby.

16.

18.

I),

20.

Ale

IPS,

24.

26.

Mic

Reprinted with permission.

Hay JL, McCaul KD, Magnan RE. Does worry about breast cancer predict screening behaviors? A meta-analysis of the prospective evidence. Prev Med. 2006;42(6):401—-408. Ferrer RA, Portnoy DB, Klein WM. Worry and

risk perceptions as independent and interacting predictors of health protective behaviors. J Health Commun. 2013;18(4):397—-409. Kelly K, Leventhal H, Toppmeyer D, et al. Subjec- tive and objective risks of carrying a BRCA1/2mu- tation in individuals of Ashkenazi Jewish descent. ] Genet Couns. 2003;12(4):351-371.

Bowen DJ, Helmes A, Powers D, et al. Predicting breast cancer screening intentions and behavior with emotion and cognition. J Soc Clin Psychol. 2003;22:213-232. Glanz K, Burke LE, Rimer BK. Health behavior

theories. In: Butts JB, Rich KL, eds. Philosophies and Theories for Advanced Nursing Practice. Burlington, MA: Jones & Bartlett; 2010:235- 256. Slovic P, Finucane ML, Peters E, et al. Risk as

analysis and risk as feelings: some thoughts about affect, reason, risk, and rationality. Risk Anal. 2004; 24:311-322. McCaul KD, O’Donnell SM. Naive beliefs about

breast cancer risk. Womens Health. 1998:;4(1): 93-101. McCaul KD, Schroeder DM, Reid PA. Breast can-

cer worry and screening: some prospective data. Health Psychol. 1996;15:430-433. Jensen JD, Bernat JK, Davis LA, Yale R. Dispo-

sitional cancer worry: convergent, divergent, and predictive validity of existing scales. ] Psychosoc Oncol. 2010;28(5):470-489. Lerman C, Trock B, Rimer BK, Jepson C, Brody

D, Boyce A. Psychological side effects of breast cancer screening. Health Psychol. 1991;10(4):259- 267.

Berrenberg JL. The cancer attitude inventory: development and validation. J Psychosoc Oncol. 1991;9(2):35-44. Champion VL, Skinner CS. A breast cancer fear scale: psychometric development. J Health Psy- chol. 2004;9:753-762. Gramling R, Anthony D, Frierson G, Bowen D. The cancer worry chart: a single-item screening measure of worry about developing breast cancer. Psychooncology. 2007316(6):593-597.

Cabrera E, Zabalegui A, Blanco I. Spanish ver- sion of the Cancer Worry Scale (CWS).

Cross cultural adaptation and validity and reliability analysis. Med Clin (Barc). 2011;136(1):8-12. Brain K, Norman P, Gray J, Rogers C, Mansel R,

Harper P. A randomized trial of specialist genetic assessment: psychological impact on women at different levels of familial breast cancer risk. Br J

Cancer. 2002;86(2):233-238.

The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

28.

EY.

30.

Bil.

32,

OAs

36.

38.

39)

40.

389

Watson M, Lloyd S, Davidson J, et al. The impact of genetic counselling on risk perception and men- tal health in women with a family history of breast cancer. Br J] Cancer. 1999;79(5-6):868-874. Custers JA, van den Berg SW, van Laarhoven HW, Bleiker EM, Gielissen MF, Prins JB. The Cancer Worry Scale: detecting fear of recurrence in breast cancer survivors. Cancer Nurs. 2014;37(1):E44- ESO. Trask PC, Paterson AG, Wang C, et al. Cancer-

specific worry interference in women attending a breast and ovarian cancer risk evaluation program: impact on emotional distress and health functioning. Psychooncology. 2001;10(5):349- 360.

Gil F, Méndez I, Sirgo A, Llort G, Blanco I,

Cortés-Funes H. Perception of breast cancer risk and surveillance behaviours of women with family history of breast cancer: a brief report on a Spanish cohort. Psychooncology. 2003312(8):821-827. Lerman C, Seay J, Balshem A, et al. Interest in genetic testing among first degree relatives of breast cancer patients. Am ] Med Genet. 1995357(3):385-392.

Gurmankin LA, Shea J, Williams SV, et al. Measuring perceptions of breast cancer risk.

Cancer Epidemiol Biomarkers Prev. 2006;15(10):

1893-1898. Wild D, Grove A, Martin M, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR Task Force

for Translation and Cultural Adaptation. Value Health. 2005;8(2):94-104. Hirai K, Shiozaki M, Motooka H, et al. Dis-

crimination between worry and anxiety among

cancer patients: development of a Brief Can- cer- Related Worry Inventory. Psychooncology. 2008;17(12):1172-1179.

MacDonald DJ, Sarna L, Uman GC, Grant M,

Weitzel JN. Health beliefs of women with and without breast cancer seeking genetic cancer risk assessment. Cancer Nurs. 2005;28(5):372-379.

Bish A, Sutton S, Jacobs C, Levene S$, Ramirez A, Hodgson S. Changes in psychological distress

after cancer genetic counselling: a comparison of affected and unaffected women. Br J Cancer.

2002;86(1):43-50. Al-Tayyib AA, Rogers SM, Gribble JN, Villarroel M, Turner CF. Effect of low medical literacy on health survey measurements. Am J Public Health.

2002;92(9):1478-1480. Weiss BD. Communicating with patients who have limited literacy skills. J Fam Pract.

1998;46(2):168-176. Bonett DG. Sample size requirements for estimat-

ing intraclass correlations with desired precision.

Stat Med. 2002;21(9):1331-1335.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

390

41.

42.

43.

44,

45.

46.

47.

48.

49.

50.

Syl

SV.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

APPENDIXJ &

Mazaheri M, Theuns P. Structural equation mod- eling (SEM) for satisfaction and dissatisfaction

ratings; multiple group invariance analysis across

scales with different response format. Soc Indicat Res. 2009;91(2):203-221. Spielberger CD. Manual of the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psycholo-

gists Press; 1983. Zotti AM, Bertolotti G, Michielin P, et al. CBA-H

Cognitive Behavioural Assessment Form Hospital. Firenze, Italy: Organizzazioni Speciali; 2010.

Satorra A, Bentler PM. A scaled difference chi-

square test statistic for moment structure analysis.

Psychometrika. 2001;66(4):507-S 14. Browne MW, Cudeck R. Alternative ways of assessing model fit. Sociol Methods Res. 1992;21(2):230-258. Hu LT, Bentler PM. Cutoff criteria for fit indexes

in covariance structure analysis: conventional cri-

teria versus new alternatives. Struct Equ Modeling. 1999;6(1):1-S5. Muthén LK, Muthén BO. How to use a Monte

Carlo study to decide on sample size and deter- mine power. Struct Equ eModeling. 2002;4:599- 620.

Fayers PM, Machin, D. Quality of Life: The Assessment, Analysis and Interpretation of Patient-ReportedOutcomes. 2nd ed. New York, NY: Wiley; 2007.

Cohen J. Statistical Power Analysis for the Behav- ioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence

Erlbaum Associates; 1988.

Morris SB, DeShon RP. Combining effect size esti- mates in meta-analysis with repeated measures and independent-groups designs. Psychol Methods. 2002;7:105-125.

Waltz CF, Strickland OL, Lenz ER. Measurement

in Nursing and Health Research. 3rd ed. New York, NY: Springer; 2005. Fornell C, Larcker DF. Evaluating structural equa- tion models with unobservable variables and mea- surement error. ] Market Res. 1981;18(1):39-5S0.

53.

San

Soe

The Cancer Worry Scale Revised for Breast Cancer Genetic Counseling

Molina Y, Ceballos RM, Dolan, ED, Albano

D, McGregor BA. Perceived breast cancer risk and breast cancer worry among women with a family history of breast cancer: a new perspec- tive on coping as a mediator. Psychooncology.

2015;24(1):113-116.

Diefenbach MA, Miller SM, Daly MB. Specific worry about breast cancer predicts mammography use in women at risk for breast and ovarian can- cer. Health Psychol. 1999;18(5):532-536. van Oostrom I, Meijers-Heijboer H, Lodder LN, et al. Long-term psychological impact of

carrying a BRCA1/2 mutation and prophylactic surgery: a 5-year follow-up study. J Clin Oncol.

2003;21(20):3867-3874.

Appendix ¢ Cancer Worry

Scale Revised for Genetic Counseling (CWS-GC).

How worried are you about the possibility of getting breast cancer someday? How much this worry affects your mood?

How much this worry interferes with your

ability to do your daily activities?

How much do you worry about the results of future mammograms?

How often do you worry about develop-

ing breast cancer?

How likely is that you have one of the genes for predisposition to breast cancer altered?

How likely is that you get breast cancer in

the course of your life?

Reprinted

with permission.

APPENDIX K

MEDICATION ADHERENCE

INTERVENTIONS, PATIENTS WITH CaD A Meta-Analysis

Jo-AnaD. Chase e¢ JenniferL.Bogener * Todd M.Ruppar e Vicki S. Conn

> Background: Despite the known benefits of initiated interventions in the inpatient setting, and

medication therapy for secondary prevention of

coronary artery disease (CAD), many patients do

not adhere to prescribed medication regimens.

Medication nonadherence is associated with poor

health outcomes and higher healthcare cost.

Objective: The purpose of this meta-analysis was to

determine the overall effectiveness of interventions

designed to improve medication adherence (MA)

among adults with CAD. In addition, sample, study

design, and intervention characteristics were explored

as potentialmoderators to intervention effectiveness.

Methods: Comprehensive search strategies

helped in facilitating the identification of 2-group,

treatment-versus-control-design studies testing

MA interventions among patients with CAD. Data

were independently extracted by 2 trained research

specialists. Standardized mean difference effect sizes

were calculated for eligible primary studies, adjusted

for bias, and then synthesized under a random-effects

model. Homogeneity of variance was explored using a

conventional heterogeneity statistic. Exploratory mod-

erator analyses were conducted using meta-analytic

analogs for analysis of variance and regression for

dichotomous and continuous moderators, respectively.

Results: Twenty-four primary studies were

included in this meta-analysis. The overall effect

informed providers of patients’ MA behaviors.

Medication adherence interventions tested among

older patients were more effective than those

among younger patients. The interventions were

equally effective regardless of number of interven-

tion sessions, targeting MA behavior alone or with

other behaviors, and the use of written instructions

only.

Conclusions: |nterventions to increase MA among

patients with CAD were modestly effective. Nurses

can be instrumental in improving MA among these

patients. Future research is needed to investigate

nurse-delivered MA interventions across varied

clinica! settings. In addition, more research testing

MA interventions among younger populations and

more racially diverse groups is needed.

Key Words: coronary artery disease - medication

adherence - meta-analysis - patient compliance

# Introduction

Heart disease is the leading cause of death among adults in the United States. !7

Coronary artery disease (CAD), the most

size of MA interventions, calculated from 18,839

participants, was 0.229 (P< .001). The most effec-

tive interventions used nurses as interventionists,

Reprinted with permission from Chas, J. D., Bogener, J. L., Ruppar, 7. M., Conn, V. S. (2016). The Effectiveness 391

of medication adherence interventions among patients with coronary artery disease: A meta-analysis. Journal of

Cardiovascular Nursing, 31(4), 357-366.

392 APPENDIXK &

common form of heart disease, is responsi- ble for 385,000 deaths and $108.9 billion

in healthcare expenditures annually.'” Secondary prevention for CAD is amulti-

intervention approach involving therapeutic lifestyle changes and evidence-based medical therapies, such as prescribed medications. Between 1980 and 2000, these therapies have

contributed to a 50% reduction in CAD-

related deaths.* Research suggests that the

greatest contributor to this reduction is medi-

cations for secondary prevention of CAD. Unfortunately, medication nonadherence is

highly prevalent.* Approximately one-third of patients who have had a myocardial infarc-

tion do not adhere to prescribed medication

regimens.’ Nonadherence is associated with

increased risk for all-cause and cardiovascu- lar mortality, revascularization procedures,

hospitalization, and higher healthcare cost.°*

Effective interventions to improve medica-

tion adherence (MA) in this population are

critically needed.

Efficacy of MA interventions varies.”

Few systematic reviews have focused on MA interventions among patients with CAD.'*"® Prior reviews have been limited by narrow

search strategies, unclear inclusion criteria,

lack of a quantitative synthesis, or absent exploration of potential moderating vari-

ables.'® To date, no current meta-analyses

addressing MA intervention effectiveness among patients with CAD exist. Thus, the overall effectiveness of MA interventions in

this population is unclear; furthermore, the most effective types of interventions are yet

unknown.

A meta-analysis and moderator analysis of MA interventions among patients with CAD

could promote efficiency in developing future interventions and provide clinicians with

guidance to promote MA in clinical practice.

The purposes of this systematic review and meta-analysis were to describe and quantify the overall effectiveness of the body of MA intervention research among patients with

CAD and to explore potential moderators

of intervention effectiveness. In addition, we

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Medication Adherence Interventions, Patients with CAD

identified limitations in the extant research and suggested areas for future study.

The following research questions guided

this study:

1. What is the overall effectiveness of MA

interventions on MA outcomes among

patients with CAD? 2. Does intervention effectiveness vary

based on intervention, sample, or design

characteristics?

=# Methods

The systematic review and meta-analysis

were performed using standard meta-analysis

techniques and PRISMA guidelines.!° This project was part of a larger parent study examining MA outcomes of MA interventions

across multiple chronic and acute illnesses.

SEARCH STRATEGIES

We consulted an expert health sciences

reference librarian to ensure comprehensive search strategies.”' Databases that were searched included the following: MEDLINE,

PubMED, PsychINFO, CINAHL, EBSCO,PQDT, Cochrane Central Trials Register, Cochrane Database of Systematic Reviews, IndMed, ERIC, International

Pharmaceutical Abstracts, EBM Reviews-

Database of Abstracts of Reviews of Effects,

as well as Communication and Mass Media.

Broad MeSH terms were used, which

included the following: patient compliance,

medication adherence, drugs, prescription drugs, pharmaceutical preparations, generic,

dosage, compliant, compliance, adherent, adherence, noncompliant, noncompliance,

nonadherent, nonadherence, medication(s),

regimen(s), prescription(s), prescribed,

drug(s), pill(s), tablet(s), agent(s), improve,

promote, enhance, encourage, foster, advo-

cate, influence, incentive, ensure, remind,

Reprinted

with permission.

na APPENDIXK #@

Optimize, increase, impact, prevent, address, decrease. Fifty-seven relevant journals were

hand-searched, and author searches and

ancestry searches of prior reviews’ bibliog-

raphieswere conducted to identify additional potentially eligible studies.

INCLUSION CRITERIA

We included 2-group, treatment-versus-

control comparison studies testing interven-

tions to increase MA in patients 18 years or

older with a diagnosis of CAD, defined by the primary studies. Medication adherence

interventions are deliberate actions performed

or directed by investigators to increase

adherence to specified medication regimens. Examples include education, reminders, and

special packaging. Studies with varied types of MA measurement (eg, electronic monitoring

devices, pharmacy refills, self-report) were included, given the diversity of MA measures in this research area. Eligible studies needed

to contain enough data to calculate an effect

size (ES). The research team attempted to con-

tact corresponding authors to obtain missing outcome data.

DATA EXTRACTION

To extract relevant data from primary studies,

a coding strategy was developed from prior

research and expert consultations. The code-

book was developed through an iterative pro- cess and pilot tested. Data extracted included

the primary study source, publication date,

dissemination type (eg, journal article, dis-

sertation), pfesence of funding, participant demographics (eg, age, gender, ethnicity, comorbidities), research methods, intervention

details, and MA outcomes.Multiple descrip-

tors of primary study research methods were coded, such as sample size, randomization,

and intention-to-treat analyses. Method of

MA measurement and follow-up interval were recorded. Varied intervention characteristics

Reprinted

with permission.

Medication Adherence Interventions, Patients with CAD 393

were coded, including content (eg, problem solving, self-monitoring, goal setting), delivery (eg, face-to-face, telephone), dose (eg, length/ number of sessions), and setting (eg, clinic, home).

Included studies were independently coded by 2 extensively trained research specialists,

then compared and discussed until consensus was reached. A doctorally prepared senior

research specialist supervised the coding pro-

cess to ensure coding integrity and reviewed

all ES data. Questionable items were resolved

in team meetings with the study principal investigator.

DATA ANALYSIS

All data were analyzed using Comprehensive

Meta- Analysis Software.”* Standardized

mean difference effect sizes (d, ES) were

calculated for each 2-group treatment- versus-control posttest comparison. The

standardized mean difference ES between the groups was calculated by dividing the

difference between treatment and control group post intervention means by the pooled

standard deviation. Additional ES analyses

were conducted within the groups by sub- tracting the outcome scores from the baseline scores and dividing by the baseline standard

deviation. Effect sizes were weighted by the inverse of variance to account for sample

size and adjust for bias, then synthesized

using a random-effects model.*? A random-

effects model was chosen a priori, given the

expected within- and between-study variance

across primary studies. Data were examined for possible outliers on the basis of standard-

ized residuals of each primary study’s ES.

Publication bias was examined by assessing the symmetry of a funnel plot constructed by

plotting each primary study’s standard error

against its ES.*° Homogeneity of variance was tested using

a conventional heterogeneity statistic (Q),

to quantify observed heterogeneity across

studies, and I,” to determine the proportion of

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

394 APPENDIXK #

observed heterogeneity due to true differences in effects across studies.*> Exploratory mod-

erator analyses were used to examine possible

associations between study characteristics

and intervention effectiveness. Dichotomous variables were evaluated using subgroup anal- ysis, and continuous variables were evaluated

using meta-regression.”*

H Results Y

Twenty-four primary reports were eligible for analysis. > !*°44! Additional coding informa-

tion was found in 4 companion reports about

the same primary studies. *7** Three primary

study reports contained multiple comparison

groups.°°°°” There were 28 treatmentversus-

control-group posttest comparisons, 9 treat- ment group pretest-posttest comparisons, and 6 control group pretest-posttest comparisons. Few smaller studies with negative findings

were included, indicating evidence of publica- tion bias.

Medication Adherence Interventions, Patients with CAD

PRIMARY STUDY CHARACTERISTICS

The primary studies that were included in this metaanalysis included 24 journal articles, 3

dissertations, and 1 presentation. Six studies were disseminated before 2000. Seventeen studies were supported by funding.

Primary study characteristics are presented

in Table 1. Majority of the samples were males. The median of the mean age for partic- ipants was 62.9 years. Only 7 studies reported

data on ethnicity. Of those, most subjects were white. Some studies reported additional chronic diseases among their subjects includ- ing the following: hypertension (k = 17), undifferentiated diabetes (k = 16), hyperlipid- emia (k = 12), heart failure (k = 4), stroke

(k = 3), lung disease (k = 3), renal disease

(k = 2), osteoarthritis (k = 1), asthma (k = 1),

atrial fibrillation (k = 1), nephritic syndrome

(k = 1), thyroid disorder (k = 1), and cerebral

vascular disease (k = 1).

Primary studies reported diverse meth-

ods. The median number of intervention

sessions was 2 (k = 17). The median number

of days for MA intervention duration was

Table 1 Characteristics of Primary Studies Included in Medication Adherence Meta-analyses

Characteristics k Min

Treatment group sample size 28 4

Control group sample size 24 5

Percentage attrition 23 0

Percentage of females 23 0

Percentage underrepresented 7 7

group subjects

Mean age, y 21 yeh 7/

Median number of 17 1

intervention sessions

Median duration of 23 1

interventions, d

Median duration 14 12

postintervention for MA

outcome data collection, d

0, Median 0; Max

18.75 86.5 246.5 3635

21 82 562 3010

0 4.545 14.646 65.282

25 40 51.05 67.4

24.1 48 90.4 O239

58.4 62.9 64 72.22

1 2 5 2

1 35 126 365

40.25 124.5 ATA 700

k, number of comparisons in which characteristic was reported; Min, minimum; Max, maximum; Q,, first quartile; QO, third quartile.

Generating and Assessing Evidence for Nursing Practice (11th ed.) Reprinted

with permission.

~ APPENDIXK ®& Medication Adherence Interventions, Patients with CAD 395

35 (k = 23). Only 1 study reported interven-

tion session duration. Outcome data of MA were collected with a median of 124.5 days after intervention (k = 14). Studies reported diverse methods of collecting MA outcomes including pharmacy refill (k = 7), selfreport

(k = 18), biological measures (k = 2), and pill

counts (k = 1).

OVERALL EFFECTS OF MEDICATION ADHERENCE INTERVENTIONS OF MEDICATION

Adherence Outcomes. Overall MA ESs are presented in Table 2. The ESs were calcu-

lated for 28 treatment-versus-control-group comparisons containing 18,839 subjects. The

overall ES for these comparisons was 0.229 (P < .001), indicating significant improve- ments in MA outcomes in the treatment over

the control group (Figure 1). When the 3

largest sample studies were excluded, the ES for these comparisons demonstrated minimal change (d = 0.269, P < .001). The ESs were

significantly heterogeneous.

We also calculated overall ESs for the 9 treatment group pretest-posttest comparisons and for the 6 control group pretest-posttest comparisons. Although the former ES was

positive (0.183) and the latter negative

(-0.014), neither were statistically significant.

Lack of statistical significance may reflect low power from the small number of comparisons.

Moderator Analyses. Continuous and

dichotomous moderator analyses are displayed in Tables 3 and 4, respectively. Although all studies from the main analysis were examined for moderating variables, only those mod- erators reported for a sufficient number of

comparisons were included in the analyses.

Intervention Moderators. Studies in which health care providers were given information

about subjects’ MA revealed a significantly

greater ES (0.387) than when the providers

were not given information on MA (0.151). An

example of this type of intervention component

could involve using a questionnaire on par-

ticipants’ baseline MA and barriers to MA.4 Studies with nurse interventionists (0.428)

reported significantly higher MA than studies

without nurse interventionists (0.127). Studies

with and without physician and pharmacist interventionists had similar ESs. Interventions

started when participants were inpatients had significantly larger effects (0.590) than interventions that did not start with inpatients (0.141); however, there was little difference

when the intervention was delivered at home versus in the clinic. With regards to the mode of intervention delivery, we saw no significant

differences among telephone, written materials only, or face-to-face delivery. Interventions

using mail delivery were less effective (0.060) than interventions without mail delivery inter-

ventions (0.292). There were several nonsignif-

icant variables, including: utilization of theory,

number of sessions, duration of intervention,

time point for measuring outcome MA, goal

setting, interventions delivered at home, inter- ventions delivered in clinic, problem solving,

succinct written instructions, any written

instructions, behavior target (MA or multiple behaviors), physician or pharmacist interven- tionists, telephone and face-to-face delivery, and written instructions only.

Report and Sample Moderators. The age

of subjects had a significant positive slope (0.014), revealing thatMA interventions led

to greater adherence improvement in samples of older patients. Interventions were equally

effective regardless of publication status, funding, and location. Other nonsignificant

moderators included year of publication, percentage of women and underrepresented

groups, and socioeconomic status.

Design and Methods Moderators.

Although sample size had a statistically significant negative slope, this finding is not

clinically substantive. Other potential moder- ators related to design, such as blinding, allo-

cation concealment, random ssignment, and

intention-totreat analyses, were not associated

with MA effectiveness.

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

Medication Adherence Interventions, Patients with CAD APPENDIX K 396

+ ‘papnpoxa

sarpnys

ajdures

rad1e]

sary,

iP 2P Uj OU r

So Ip ug s

“J OM 9

pr ep ur s

“A S

‘ o s e I s

A a U a s o w O Y

[e uO

TU aA

UO D

“G O

“s uo

st ie

dt uo

s yo

ra qu in u

‘s js ay ya

sa ou

dI az

an n

ON P

92 18

19 9} J2

SS OI

BU LI IL A

Pa as as qo

u o N o d o s d

“7

f9 zI

S 1D

a} Ja

so ua rA FF IP

uK dU

I po

zi ps

ep ue

s Pp

j s a u s o d

j s e l a i d

67 0°

€S 50 °S S

DC L

66 0° 0

O8 L‘ 0

8 0 2 ' 0 -

L8 3°

vV LO 'O -

9 d n o i 6

jo uj uo g

ys el 1s od

js a} 01 d

LO O' >

€ 8 v ' 8 8

C 9 6 9

EL L‘ O

GO V' 0

6 € 0 ' 0 -

90 L"

€8 L° 0

6 d n o s 6

j u e w j e a s )

q i s e y s o d

s d n o u b

LO O' >

v 6 C ' E 9

V 8 E ' G 9

89 0° 0

€ 0 V ' 0 - G E L ' O

LO O' >

6 9 2 0

JO AJ UO D

J U d L U } e

8 1

ei se }1 so d

s d n o i b

LO O' >

v L V ' S 9

LO ?’

£v 0' 0

LC E

O - 8 E L

‘0

LO O’ >

6¢ 2' 0

|O 4} UO D

J U S

ea d]

(0 )d

0 aS

je as aj uy

(P )d

p ¥

uo si ed ui og

B I U A P Y U O )

% G 6 e e

( P R U

R E S

H S

as ea si g

M a y y

Ar eu oi 09

y y y

Sj ua ne g

Bu ow y

su on ua ni aq uy

JI Ua IA YP Y

UO He II pa yy

sj aa yy

|j es 9a AQ

aj qe y

Reprinted with permission.

ce Manual for Nursing Research: Generating and Assessing Evidence for Nursing Practice (11th ed.)

eS APPENDIXK & Medication Adherence Interventions, Patients with CAD 397

Study name Statistics for each study Std diff in means and 95% Cl

Std diff Standard Lower Upper in means error limit limit

2012 0.516 0.228 0.069 0.962

2012 0.140 0.164 -0.182 0.462

2012 0.075 0.164 -0.245 0.396

2012 -0.077 0.174 -0.418 0.265

2011 0.383 0.694 -0.977 1.742

2011 0.151 0.026 0.099 0.202

2011 -0.411 0.369 -1.134 0.312

2010 -0.021 0.139 -0.294 0.251

2010 0.455 0.425 -0.378 1.288

2009 0.598 0.142 0.319 0.876

2008 0.382 0.812 -1.208 1.973

2008 0.541 0.796 -1.019 2.100

2008 -0.020 0.213 -0.438 0.397

2008 0.114 0.195 ~0.268 0.496

2007 0.194 0.078 0.040 0.348

2007 0.284 0.156 -0.021 0.589

2006 0.143 0.381 -0.602 0.889

2006 0.242 0.432 -0.605 1.089

2005 0.375 0.158 0.065 0.685

2004 0.979 0.193 0.600 1.358

2004 0.132 0.057 0.019 0.244

2001 0.059 0.042 -0.023 0.142

2000 0.000 0.503 -0.986 0.986

1998 0.424 0.077 0.274 0.574

1990 -0.153 0.283 -0.708 0.402

1988 0.739 0.387 -0.019 1.497

1986 0.132 0.330 -0.515 0.780

1985 2.521 0.585 1.374 3.668

Summary Effect 0.229 0.047 0.138 0.321

-4.00 -2.00 0.00 2.00 4.00

Favors Control Favors Treatment

Figure 1. Forest plot of main effects. Forest plot of meta-analysis of two-group posttest comparisons of

medication adherence outcomes listed by year of publication. Effect sizes calculated using a random effects

model. Study weight is proportional to the area of each square.

= Discussion research exploring MA and blood pressure

outcomes*®? as well as cardiovascular disease

Findings from this meta-analysis, which is the first of its kind, that suggest interventions to increaseMA among participants with CAD

were significantly effective. These positive find- ings are similar to prior meta-analyses exam- ining MA outcomes from MA interventions

among underrepresented groups and from

packaging intervention effects.*°*” Although poor MA has been linked to negative health outcomes in patients with CAD,**” consensus

on how much MA is needed to improve varied

CAD-related outcomes is not yet clear. Prior

Reprinted

with permission.

risk exists.*”? However, further research is

needed to quantify the amount of MA needed to mitigate additional CAD-related outcomes.

Moreover, the dose of MA intervention needed

to change MA behavior among patients with CAD is yet to be determined. Due to the small

number of comparisons using similar measures of MA, we were unable to convert the ES to a

clinical metric of adherence. Future MA inter-

vention research among patients with CAD

should include explicit information regarding

intervention dose.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

398 APPENDIXK #

Table 3 Continuous Moderator Results

Medication Adherence Interventions, Patients with CAD

Moderator k B SE iv

Report and methods moderators .

Year of publication 28 —0.005 0.004 .205

Sample size 28 —0.000 0.000 .004

Sample attribute moderators

Age 21 0.014 0.004 .001

Percentage of women 23 —0.000 0.002 .968

Underrepresented groups 7 0.000 0.001 .810

Intervention feature moderator

No. sessions . i7/ —0.013 0.013 .304

Duration of intervention 23 —0.000 0.000 EOT2

Time point for MA outcome data 14 —0.000 0.000 28}

collection

B, meta-regression coefficient (unstandardized); k, number of comparisons; p, value for B; SE, standard error.

MODERATOR FINDINGS

We found several interesting moderators.

Interventions in which healthcare providers were given information regarding participants’ MA

were more effective than interventions without

this component. Awareness of patients; MA

behavior canmotivate and guide providers to address issues related to MA. Clinicians work-

ing with patients with CAD should assess issues

with or barriers to MA to identify the possible

need to intervene. Future research might directly

compare an intervention that provides patient

MA status to healthcare providers to a similar

intervention without this provision.

Medication adherence interventions

delivered by nurses were especially effective. Nurses have considerable access to patients

with CAD in outpatient settings, such as cardiac rehabilitation and clinics. In addition,

nurses working in the inpatient setting spend approximately 25% to 37% of their time

providing direct patient care and 11% to 21%

of their time in medicationrelated tasks.°°°! In

addition to substantial access to this patient

population, nurses also have clinical skills to promote MA. For example, nurses have

delivered efficacious MA interventions through counseling,** follow-up communication,””>>*4

and case management. °° Nurses should play

an active role in developing and implementing

MA interventions among patients with CAD.

Research exploring nursing interventions to

increase MA among patients with CAD could

focus on testing or comparing specific interven-

tion strategies such as education, counseling,

and managing barriers. Specific nurse type

and training were not clearly reported among

the studies, hindering the comparison of MA

intervention effectiveness across different types of nurses. Investigators of future studies should explicitly identify types of nurses delivering MA interventions among patients with CAD.

Medication adherence interventions

initiated in the inpatient setting were more

effective. The inpatient setting may provide an opportunity for clinicians to inform patients

and families about the importance of med- ications for secondary*prevention of CAD

as well as strategies for MA. Moreover, the

dire nature of hospitalization may influence patient and family receptivity to MA interven-

tions. Most MA interventions initiated in the

inpatient setting included follow-up inter- vention content after discharge. Continued reinforcement of MA after discharge may positively affect MA outcomes. For those patients who may start medications outside the hospital, interventions delivered at home

or in the clinicwere equally effective. Future

Reprinted

with permission.

Bi APPENDIXK ®& Medication Adherence Interventions, Patients with CAD

Table 4 Dichotomous Moderator Results a ea a acheter ee J

399

Moderator k d SE 0, P

Report moderators

Publication status 1.267 .260

Unpublished (eg, dissertation, 4 0.724 0.474

presentation)

Published article 24 0.189 0.037

Presence of funding for research fein .167

Unfunded 11 0.452 0.192

Funded (any funding reported or 17 0.182 0.040

acknowledged)

Socioeconomic status 0.194 .660

Not reported as low income 24 0.237 0.046

Reported as low income 4 0.352 0.259

Location 0.531 .466

Not North America 7 0.380 0.125

North America 21 0.182 0.045

Research methods moderators

Allocation to treatment and control 0.200 .655

groups

Not random assignment 8 0.199 0.068

Random assignment 20 0.244 0.072

Allocation concealment 1.222 .269

Allocation not concealed iS 0.188 0.050

Allocation concealed 16: 0.319 0.108

Theory 0.167 .683

No theory 23 0.239 0.050

Any theory 5 0.184 0.124

Data collectors blinded 0.481 .488

Data collectors not blinded 18 0.207 0.052

Data collectors blinded 10 0.293 0.112

Intention-to-treat 0.000 .997

No intention-to-treat 23 0.236 0.063

Intention-to-treat 5 OR237/ 0.097

Intervention feature moderators

Goal setting 0.095 .758

No goai setting 23 0.227 0.050

Goal setting 5 0.183 0.135

Healthcare provider given information 3.899 .048

about MA

Healthcare provider NOT given 20 0.151 0.042

information about MA

Healthcare provider given 8 0.387 Oni

information about MA

(continued)

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

400 APPENDIX K ™ Medication Adherence Interventions, Patients with CAD

Table 4 (continued)

Moderator k d SE 0; P

Intervention delivered at home 0.676 411 Not at home 23 0.254 0.053

At home 5 0.129 0.143

Intervention delivered at clinic 0.705 401 Not at clinic 23 0.213 0.049

At clinic 5 0.320 0.118

Intervention started while subjects 8.448 .004 were inpatients

Not inpatients 19 0.141 0.037

Inpatients g) 0.590 0.150

Problem solving 0.307 .580

No problem solving 22 0.245 0.054

Problem solving 6 0.188 0.088

Self-monitoring of medications 1.198 .274

No self-monitoring PAs) 0.195 0.045

Self-monitoring 3 0.492 0.267

Succinct written instructions 1.820 WA

No succinct written instructions 22 OF255 0.054

Succinct written instructions 6 0.124 0.080

Any written instructions 2.868 .090

No written instructions 8) 0.287 0.065

Any written instructions 9 0.149 0.049

Behavior target 212 ial

Multiple behaviours sl 0.306 0.109

MA only 17 0.179 0.038

Part of intervention delivered to 0.476 .490

providers

Not delivered to providers 24 0.213 0.053

Delivered to providers 4 0.311 0.131

Nurse interventionist 6.502 nO |

No nurse 18 0.127 0.020

Any nurse 10 0.428 0.116

Physician interventionist 0.397 529)

No physician 21 0.223 0.050

Physician 7 0.322 O43

Pharmacist interventionist 0.310 578

No pharmacist 21 0.240 0.056

Pharmacist 7 0.193 0.062

Mail delivery 10.845 .001

No mail delivery 23 0.292 0.059

Mail delivery 5 0.060 0.038

Telephone delivery 0.701 .403 No telephone delivery 14 On1g2 0.065

Telephone delivery 14 0.280 0.082

a APPENDIXK #&

Table 4 (continued)

Medication Adherence Interventions, Patients with CAD 401

—_——

Moderator d SE 0; P Written materials ONLY

No written intervention

Written intervention

Face-to-face delivery

No face-to-face

Face-to-face

2.985 .084 0.248 0.049

0.008 0.130

2.604 .107

0.143 0.048

0.288 0.076

k, number of comparisons; d, standardized mean difference effect size; SE, standard error; Op, sum of weighted sum of squares of subgroup means about overall mean; p, value for O,

research might directly compare MA interven- tions initiated in the inpatient setting to MA

interventions initiated after hospitalization.

Regarding sample characteristics, only age

appeared to impact intervention effectiveness. As the age of the sample increased, so did the intervention effectiveness. These findings support prior research related to statin MA and

low-density lipoprotein goal attainment.°””*

Chi and colleagues*” postulated that older individuals are more likely to have multiple comorbidities and may be more attentive to

prescribed medication regimens. Additional primary research is needed to identify effective

MA interventions among younger populations

with CAD. Furthermore, more primary research

involving more diverse samples is needed.

Deaths related to CAD are higher among

African Americans than whites and other groups.’ Rates of MA for various chronic diseases also differ across race and ethnicity,

with minority groups being less adherent to pre- scribed medications.°°' However, few primary studies included in this metaanalysis reported racially or ethnically diverse groups. Thus,

future primary research testing MA interven-

tions among patients with CAD must strive to

include minority groups to reduce this disparity. We found some interesting nonsignificant

moderators. Interventions focusing solely on

MA were as effective as interventions that had multiple behavioral foci. Thus, clinicians may take the opportunity to introduce strategies for MA while discussing other health behaviors with CAD patients. The use of only written

Reprinted

with permission.

material did not impact intervention effective-

ness, suggesting that providers should consider using more than this type of delivery when pro-

moting MA among patients with CAD. Future MA intervention research among patients with

CAD should incorporate additional forms of intervention delivery beyond written materi-

als. Number of intervention sessions did not appear to be a significant moderator. It is

possible that even 1 or 2 intervention sessions may be effective in changing MA behavior among patients with CAD. However, addi- tional research testing or comparing various aspects of intervention dose could help identify the most effective dose needed to change MA behavior. We did not identify any specific

intervention strategy that increased MA intervention effectiveness; however, lack of

statistical significance of these moderators may

be related to the small number of comparisons.

scape

What’s New and Important

e Interventions designed to increase

MA among patients with CAD are

modestly effective.

e In this patient population, nurse-

delivered MA interventions were

more effective than interventions

not delivered by nurses.

e Among patients with CAD, MA

interventions initiated in the inpa-

tient setting can be more effective

than interventions initiated in the

outpatient setting.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

402 APPENDIXK #8

Medication adherence interventions delivered by physicians or pharmacists were

equally effective as interventions not delivered by these providers. Although these findings suggest that involving these providers may not increase MA intervention effectiveness, the

number of studies incorporating these types of interventionists was small. Future research

could directly compare similar MA interven- tions among patients with CAD delivered by different clinicians. Additional research may

also explore variations in MA intervention

delivery across diverse healthcare providers. This meta-analysis was limited by some

primary study characteristics. Although

efforts were made to contact corresponding authors, some studies were excluded because

critical data were missing from primary

study reports. Primary study reporting limits

the generalizability of this study’s findings

to more diverse populations. Primary study quality is an important issue in meta-analysis

work. Multiple strategies are recommended

to manage primary study quality.°*° We

used specific inclusion criteria to capture

reports with more rigorous study designs, employed analysis techniques accounting for study heterogeneity, and explored study

quality empirically through moderator anal-

yses. Some publication biases were present.

Smaller, negative studies are less likely to be

published; therefore, access to these studies

is limited. Despite extensive search strate-

gies, capturing these relevant studies was a challenge.

Primary study reporting affected the abil- ity to identify effective combinations of MA components. Several studies used multiple

intervention strategies; however, combina-

tions of strategies were inconsistent. Thus,

determining the most effective combina-

tion of MA intervention strategies was not

possible.

Measurement error within the primary studies could have introduced bias toward overestimation of MA intervention effects.

Objective measures are the most sensitive and

specific means of measuringMA“*,®; however,

most included studies used self-reported MA,

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Medication Adherence Interventions, Patients with CAD

which is known to over estimate patients’ MA.® Future MA intervention research

conducted among patients with CAD should consider using objective measures of MA to

reduce bias. Meta-analyses are observational studies.

The moderator findings of this study are intended to promote additional exploration in this area of study. The scope of this meta- analysis is limited to MA among patients with CAD. Therefore, interpretation of these findings may not be possible among patients with other chronic illnesses or other forms of

heart disease.

# Conclusion

Medication management is an important

aspect of secondary prevention for CAD. Nonadherence to prescribed medications for CAD has been linked with multiple poor outcomes. Findings from this meta-analysis suggest that MA interventions among patients

with CAD are effective, especially among older patients. Clinicians working with

patients with CAD evaluate patients’ MA

behavior before initiating interventions to

improve MA. Nurses are on the front lines

of health behavior promotion among these patients and can be effective MA intervention- ists. Future research is needed to explore MA interventions among younger populations and more racially diverse groups.

Jo-Ana D. Chase, PhD, ARRN-BC, is Assistant

Professor, S343 School of Nursing, University of Missouri, Columbia.

Jennifer L. Bogener, BSN, is Nursing Student,

School of Nursing School of Health Professions,

University of Missouri, Columbia. Todd M. Ruppar, PhD, RN, is Assistant Professor,

S423 School of Nursing, University of Missouri, Columbia.

Vicki S. Conn, PhD, RN, FAAN, is Potter-Brinton

Professor and Associate Dean for Research,

S317 School of Nursing University of Missouri Columbia.

Reprinted

with permission.

oa APPENDIX K

Supported by Award Number ROINR011990 (Conn-PI) from the National Institute

of Nursing Research. The content is solely the responsibility of the authors

and does not necessarily represent the official views of the National Institute of Nursing Research or the National Institutes of Health.

The authors have no conflicts of interest to

disclose.

Correspondence

Jo-Ana D. Chase, PhD, APRN-BC, $343

School of Nursing, University of Missouri, Columbia, MO 65211

([email protected]).

DOI: 10.1097/JCN.0000000000000259

REFERENCES ale

10.

Reprinted

with permission.

Centers for Disease Control and Prevention. Heart

Disease Facts. 2014. http://www.cdc.gov/heartdis- ease/facts.htm. Accessed July 16, 2014.

. National Heart, Lung, and Blood Institute. Mor-

bidity and Mortality: 2012 Chart Book on Cardio- vascular, Lung, and Blood Diseases. Washington, DC: National Institutes of Health; 2012.

. Ford ES, Ajani UA, Croft JB, et al. Explain-

ing the decrease in U.S. deaths from coro- nary disease, 1980-2000. N Engl J Med. 2007335 6(23):2388-2398.

. Ho PM, Bryson CL, Rumsfeld JS. Medication ad-

herence its importance in cardiovascular outcomes.

Circulation. 2009;119(23):3028—303S. . Naderi SH, Bestwick JP, Wald DS. Adherence

to drugs that prevent cardiovascular disease: meta-analysis on 376,162 patients. Am | Med. 2012;125(9):882—887.

. Chowdhury R, Khan H, Heydon E, et al. Adher- ence to cardiovascular therapy: a meta-analysis of prevalence and clinical consequences. Eur Heart J. 2013334(38):2940-2948.

. Sokol MC, McGuigan KA, Verbrugge RR, Epstein

RS. Impact of medication adherence on hospi- talization risk and healthcare cost. Med Care.

2005;43(6):521—530. . Ho PM, Magid DJ, Shetterly SM, et al. Medication

nonadherence is associatedwith a broad range of adverse outcomes in patients with coronary artery

disease. Am Heart J. 2008;155(4):772-779.

. Kelly JM. Sublingual nitroglycerin: improving patient compliance with a demonstration dose. J Am Board Fam Pract. 1988;1(4):251—254.

Nicoleau CM. Evaluation of a comprehensive cardiac rehabilitation program [dissertation]. New York, NY: Yeshiva University; 1985.

Medication Adherence Interventions, Patients with CAD

ily

14.

1S.

16.

18.

19.

20.

Bale

227

23)

24.

403

. Zhao Y. Effects of a discharge planning inter- vention for elderly patients with coronary heart disease in Tianjin, China: A randomized controlled

trial. 2004. http://search.proquest.com.proxy.mul. missouri.edu/pqdt/docview/305041963/abstract/

CE2FDS6D4F7B49F2PQ/1 2accountid=14576.

Accessed June 11, 2014.

Costa e Silva R, Pellanda L, Portal V, Maciel

P, Furquim A, Schaan B. Transdisciplinary approach to the follow-up of patients after myocardial infarction. Clin Sao Paulo Braz. 2008;63(4):489—496. Lourenco L, Rodrigues RCM, Gallani CB, Spana

TM. Effectiveness of the combination of planning strategies in adhering to the drug therapy and health related quality of life among coronary heart disease outpatients. Paper presented at: Interna- tional Nursing Intervention Conference; 2011; Montreal, Canada.

Miller P, Wikoff R, Garrett MJ, McMahon M,

Smith T. Regimen compliance two years after myo- cardial infarction. Nurs Res. 1990;39(6):333-336.

Ara S. A literature review of cardiovascular disease management programs in managed care popula-

tions. | Manag Care Pharm. 2004;10(4):326-344. Cutrona SL, Choudhry NK, Fischer MA, et al.

Targeting cardiovascular medication adher- ence interventions. | Am Pharm Assoc (2003).

2012;52(3):381—397.

Maddox TM, Ho PM. Medication adherence

and the patient with coronary artery disease: challenges for the practitioner. Curr Opin Cardiol. 2009324(5):468—472.

Schadewaldt V, Schultz T. Nurse-led clinics as an

effective service for cardiac patients: results from a systematic review. Int J] Evid Based Healthc.

2011;9(3):199-214.

Cooper H, Hedges LV, Valentine JC, eds. The Hand-

book of Research Synthesis and Meta Analysis. 2nd ed. New York,NY: Russell Sage Foundation; 2009.

Moher D, Liberati A, Tetzlaff J, Altman DG.

Preferred reporting items for systematic reviews andmeta-analyses: the PRISMA statement. BM].

20093339:b2535.

Reed JG, Baxter PM. Using reference databases.

In: The Handbook of Research Synthesis and Meta-Analysis. 2nd ed. New York, NY: Russell

Sage Foundation; 2009:73—101. Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Comprehensive Meta-Analysis. Englewood, NJ:

Biostat; 2005. Borenstein M, Hedges LV, Higgins JPT, Rothstein

HR. Introduction toMeta-Analysis. 1st ed. West Sussex,UK: Wiley; 2009.

Calvert SB, Kramer JM, Anstrom KJ,

Kaltenbach LA, Stafford JA, Allen LaPointe NM. Patient-focused intervention to im- prove long-termadherence to evidence-

basedmedications: a randomized trial. Am Heart J.

2012;163(4):657-665S.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

404

26.

PLY:

28.

UY).

30.

Sik,

Sue

36.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

APPENDIXK &

Campbell N, Ritchie L, Thain J, Deans H, Rawles

J, Squair J. Secondary prevention in coronary heart disease: a randomised trial of nurse led clinics in primary care. Heart. 1998;80(5):447-452.

Choudhry NK, Avorn J, Glynn BJ, et al. Full coverage for preventive medications after myocardial infarction. N Engl J Med. 20113365(22):2088-2097. Edworthy SM, Baptie B, Galvin D, et al. Effects of an enhanced secondary prevention program for pa- tients with heart disease: a prospective randomized trial. Can J Cardiol. 2007; 23(13):1066—1072.

Faulkner MA, Wadibia EC, Lucas BD, Hilleman

DE. Impact of pharmacy counseling on compliance and effectiveness of combination lipid-lowering therapy in patients undergoing coronary artery revascularization: a randomized, controlled trial.

Pharmacotherapy. 2000;20:410—416.

Gould KA. A randomized controlled trial of a discharge nursing intervention to promote self- regulation of care for early discharge interven- tional cardiology patients. Dimens Crit Care Nurs. 2011;30(2):117-125.

Guthrie RM. The effects of postal and telephone reminders on compliance with pravastatin therapy

in a national! registry: Results of the firstmyocar- dial infarction risk reduction program. Clin Ther. 2001;23(6):970—980. Jiang X, Sit JW, Wong TK. A nurse-led cardiac

rehabilitation programme improves health be- haviours and cardiac physiological risk parame- ters: Evidence from Chengdu, China.] Clin Nurs. 2007;16(10):1886-1897.

Kotowycz MA, Cosman TL, Tartaglia C, Afzal R,

Natarajan MK, et al. Safety and feasibility of early hospital discharge in ST-segment elevation myo- cardial infarctionVa prospective and randomized trial in low-risk primary percutaneous coronary

intervention patients (the Safe-Depart Trial). Am Heart J. 2010;159(1):117.

Kripalani S, Schmotzer B, Jacobson TA. Improvy- ing medication adherence through graphically enhanced interventions in coronary heart disease

(IMAGE-CHD): A randomized controlled trial. J

Gen Intern Med. 2012;27(12):1609-1617.

Lehr BK. A comparative study of self-management and cognitive behavioral therapies in the treatment of cardiac rehabilitation patients [dissertation]. Milwaukee, WI: University of Wisconsin; 1986.

MuDiz J, GFmez-Doblas JJ, Santiago-P2rez MI,

et al. The effect of post-discharge educational intervention on patients in achieving objectives in modifiable risk factors six months after discharge following an episode of acute coronary syndrome, (CAM-2 Project):Arandomized controlled trial. Health Qual Life Outcomes. 2010;8:137. Polack J, Jorgenson D, Robertson P. Evaluation of different methods of providing medication-related education to patients followingmyocardial infare- tion. Can Pharm J]. 20083;141(4):241-247.

Bis

38.

40.

41.

42.

43.

44,

a5.

46.

ATe

48.

49.

Medication Adherence Interventions, Patients with CAD

Shemesh E, Koren-Michowitz M, Yehuda R, et

al. Symptoms of posttraumatic stress disorder in patients who have had a myocardial infarction. J Consult Liaison Psychiatry. 2006;47(3):231—239. Sherrard H, Struthers C, Kearns SA, Wells G, Me-

sana T. Using technology to create a medication safety net for cardiac surgery patients: a nurse-led randomized control trial. Can J] Cardiovasc Nurs.

2009;19(3):9-15. Smith DH, Kramer JM, Perrin N, et al. A ran-

domized trial of direct-to-patient communication to enhance adherence to beta-blocker therapy following myocardial infarction. Arch Intern Med. 2008;168(5):477-483. Yilmaz MB, Pinar M, Naharci I, et al. Being well-

informed about statin is associatedwith continuous adherence and reaching targets. Cardiovasc Drugs

Ther. 2005;19(6):437—440. Zuckerman IH, Weiss SR, McNally D, Layne B,

Mullins CD, Wang J. Impact of an educational in- tervention for secondary prevention of myocardial infarction on Medicaid drug use and cost. Am J Manag Care. 2004;10(7 part 2):493—S00.

Miller P, Wikoff R, McMahon M, Garrett MJ,

Ringel K. Influence of a nursing intervention on regimen adherence and societal adjust- ments postmyocardial infarction. Nurs Res. 1988337(5):297-302. Miller P, Wikoff R, McMahon M, et al. Per-

sonal adjustments and regimen compliance 1 year after myocardial infarction. Heart Lung. 1989;18(4):339-346. Choudhry NK, Brennan T, Toscano M, et al.

Rationale and design of the Post-MI FREEE trial: a randomized evaluation of first-dollar drug coverage for post-myocardial infarction secondary preventive therapies. Am Heart J. 2008;156(1):31-36.

Gould KA. A randomized controlled trial of a discharge nursing intervention to promote self-

regulation of care for early discharge interven- tional cardiology patients. Dimens Crit Care Nurs. 2009;30(2):117-125. Conn VS, Enriquez M, Ruppar TM, Chan KC.

Cultural relevance in medication adherence inter- ventions with underrepresented adults: systematic review and meta-analysis of outcomes. Prev Med. 2014;69:239-247. Conn V. Packaging interventions to increase medica- tion adherence: systematic review and meta-analysis. Curr Med Res Opin. 20153;31(1):145—160.

Burnier M, Schneider MP, Chioléro A, Stubi

CL, Brunner HR. Electronic compliance mon-

itoring in resistant hypertension: the basis for rational therapeutic decisions. J Hypertens. 2001;19(2):335-341. Lowy A, Munk VC, Ong SH, et al. Effects on blood pressure and cardiovascular risk of varia- tions in patients’ adherence to prescribed antihy- pertensive drugs: role of duration of drug action. Int J Clin Pract. 2011;65(1):41—53.

Reprinted

with permission.

50.

Sil's

54.

56.

SIs

58.

Reprinted

with permission.

— APPENDIXK #8

Westbrook JI, Duffield C, Li L, Creswick NJ. How much time do nurses have for patients? A longitu- dinal study quantifying hospital nurses’ patterns of task time distribution and interactions with health professionals. BMC Health Serv Res. 2011;11:319. Jones M, Johnston D. Understanding phenomena

in the real world: the case for real time data collec- tion in health services research. J Health Serv Res Policy. 2011316(3):172-176. Krantz MJ, Havranek EP, Haynes DK, Smith I, Bucher- Bartelson B, Long CS. Inpatient initiation

of beta-blockade plus nurse management in vulner- able heart failure patients: a randomized study. J

Card Fail. 2008;14(4):303-309. Kirscht JP, Kirscht JL, Rosenstock IM. A test of interventions to increase adherence to

hypertensivemedical regimens. Health Educ O. 1981;8(3):261Y272. Piette JD, Weinberger M, McPhee SJ, Mah CA, Kraemer FB, Crapo LM. Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes? Am J Med. 2000;108(1):20-—27. Logan AG, Milne BJ, Achber C, Campbell WP, Haynes RB. Work-site treatment of hypertension by specially trained nurses. A controlled trial. Lancet. 1979;2(8153):1175-1178. Rudd P, Miller NH, Kaufman J, et al. Nurse man-

agement for hypertension. A systems approach. Am J] Hypertens. 2004;17(10):921-927. Chi MD, Vansomphone SS, Liu I-LA, et al.

Adherence to statins and LDL-cholesterol goal attainment. Am ] Manag Care. 2014;20(4):

e105—e112. Nag SS, Daniel GW, Bullano MF, et al. LDL-C

goal attainment among patients newly diag- nosed with coronary heart disease or diabetes in a commercialHMO. JManag Care Pharm.

2007;13(8):652—663.

Medication Adherence Interventions, Patients with CAD

Se):

60.

61.

62.

63.

64.

6S.

66.

405

Coronary Heart Disease and Stroke Deaths—United States, 2006. http://www.cdc.

gov/mmwr/preview/mmwrhtml/su6001a13.htm. Accessed June 6, 2014.

Gerber BS, Cho YI, Arozullah AM, Lee S-YD.

Racial differences in medication adherence: A cross-sectional study of Medicare enrollees. Am ] Geriatr Pharmacother. 2010;8(2):136-145.

Rolnick SJ, Pawloski PA, Hedblom BD, Asche SE,

Bruzek RJ. Patient characteristics associated with medication adherence. Clin Med Res. 2013; 11(2):54-65.

Valentine JC. Judging the quality of primary

research. In: Cooper HM, Hedges LV, Valentine

JC, eds. The Handbook of Research Synthesis and Meta-Analysis. 2nd ed. Russell Sage Foundation; 2009:122-146. Conn VS, Rantz MJ. Research methods: managing primary study quality inmeta-analyses.Res Nurs Health. 2003;26(4):322—333. Dunbar-Jacob J, Sereika SM, Houze M, Luyster FS, Callan JA. Accuracy of measures of medication

adherence in a cholesterol-lowering regimen. West J Nurs Res. 2012334(5):578-597.

Hansen RA, Kim MM, Song L, Tu W, Wu J,

Murray MD. Comparison of methods to assess medication adherence and classify nonadherence. Ann Pharmacother. 2009;43(3):413-—422.

Zeller A, Ramseier E, Teagtmeyer A, Battegay E.

Patients’ self-reported adherence to cardiovascular medication using electronic monitors as compara-

tors. Hypertens Res. 2008;31(11):2037—2043.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

A METAETHNOGRAPHY OF

TRAUMATIC CHILDBIRTH AND ITS

AFTERMATH Amplifying Causal Looping

Chery! Tatano Beck

> Abstract: \ntegrating results from multiple

analytic approaches used in a research program

by the same researcher is a type of metasyn-

thesis that has not often been reported in the

literature. In this article the findings of one type

of qualitative synthesis approach, a metaethnog-

raphy, of six qualitative studies on birth trauma

and its resulting posttraumatic stress disorder

from my program of research are presented. This

metaethnography provides a wide-angle lens

to view and interpret the far-reaching, stinging

tentacles of this often invisible phenomenon

that new mothers experience. | used Noblit and

Hare's seven-step approach for synthesizing the

findings of qualitative studies. The original trigger

of traumatic childbirth resulted in six amplifying

feedback loops, four of which were reinforcing

(positive direction), and two which were balancing

(negative direction). Leverage points that identify

where pressure in the amplifying causal loop can

break the feedback loop where necessary are

discussed.

> Key Words: childbirth - metaethnography -

metasynthesis - qualitative analysis - trauma

As Lisa recalled, “I am amazed that three

and a half hours in the labor and delivery room could cause such utter destruction in

my life. It truly was like being a victim of a

violent crime of rape” (Beck, 2004a, p. 32).

What happened to this mother that turned

her birthing dream into a rape scene? The purpose of this article is to present the results

of a metaethnography which focused not only on answering this question, but also on the repercussions of traumatic childbirth

for women. By synthesizing the results of

six qualitative studies on birth trauma and

its resulting posttraumatic stress disorder

(PTSD) from my research program, I used a wide-angle lens to view and interpret the far-reaching, stinging tentacles of this often invisible phenomenon. In two of the quali-

tative studies I examined the experience of a traumatic childbirth (Beck, 2004a, 2006b).

My focus in the remaining four studies was the aftermath of birth trauma (Beck, 2004b;

2006a; Beck & Watson, 2008; Beck &

Watson, 2010). %

— Metasynthesis

Metasynthesis is “an interpretive integration

of qualitative findings that are themselves interpretive syntheses of data, including the phenomenologies, ethnographies, grounded

theories, and other integrative and coherent descriptions or explanations of phenomena,

406 Reprinted with permission from Beck, C. T. (2011). A metaethnography of traumamatic childbirth and its aftermamath: Amplifying causal looping. Qualitative Health Research, 21(3), 301-311.

ie APPENDIXL #

events, or cases that are the hallmarks of qual-

itative research” (Sandelowski & Barroso,

2007, p. 151). The aim of a metasynthesis is

not to focus on the similarities of the results of the qualitative studies included in the meta- synthesis, but instead to delve further into

these findings to unearth new information to increase our understanding of the phenom- enon (Paterson, Thorne, Canam, & Jillings,

2001). Sandelowski and Barroso differenti-

ated between qualitative metasynthesis and qualitative metasummary. Qualitative meta- summary is “a quantitative oriented aggrega-

tion of qualitative findings that are themselves topical or thematic summaries or surveys of data” (p. 151). Qualitative metasyntheses are more than just summaries. Their end product

is a new interpretation of the findings. Metasyntheses help to prevent what Glaser

and Strauss (1971, p. 181) warned as qual-

itative research studies’ results remaining as

“respected little islands of knowledge sepa-

rated from others and not helping to build a cumulative body of knowledge in a substantive area.” With more and more focus on meta- synthesis, qualitative scholars are now delving

further into its implications and applica-

tions (Thorne, Jensen, Kearney, Noblit &

Sandelowski, 2004). Examples of recent meta-

syntheses span topics such as withdrawing life-sustaining treatments (Meeker & Jezewski, 2009), mothers’ confidence in breastfeeding (Larsen, Hall, & Aagaard, 2008), diabetes

in nine South Asian communities (Fleming & Gillibrand, 2009), healing from sexual

violence (Draucker et al., 2009), and the hope

experience of family caregivers of chronically ill persons (Duggleby et al., 2010).

Three types of metasyntheses are avail-

able to researchers (Sandelowski, Docherty,

& Emden, 1997). The most frequently used type involves synthesizing results across studies on the same topic conducted by dif- ferent researchers. A second type consists of using quantitative approaches to synthesize

qualitative results from cases across differ- ent studies. Integrating results from multi- ple analytic approaches used in a research

Reprinted

with permission.

A Metaethnography of Traumatic Childbirth and Its Aftermath 407

program by the same researcher is the third type. An example of this third kind of qualitative metasynthesis is a synthesis of the transition to parenthood of infertile couples (Sandelowski, 1995). This is the only meta- synthesis located to date in which a series of qualitative research studies on a phenome- non conducted by the same researcher were synthesized.

Kearney (2001) described current

approaches to the synthesis of findings of

qualitative research studies into a new inte- grated whole as the meta family. Included in this meta family are such approaches as

metastudy, metainterpretation, metaethnog- raphy, and grounded formal theory. Kearney placed these different synthesis approaches on an interpreting—theorizing continuum. On

the theorizing end is formal grounded theory

(Glaser, 2007), and on the interpretive end is

metaethnography (Noblit & Hare, 1988).

@ Research Design

This metaethnography of birth trauma and its resulting PTSD resulting from childbirth

was generated from the findings of six studies I conducted which were published between 2004 and 2010 (Beck 2004a, 2004b, 2006a, 2006b; Beck & Watson, 2008, 2010). Meta-

ethnography is the synthesis of interpretive research. It involves a rigorous approach for constructing substantive interpretations

about a group of qualitative studies. A meta- ethnographer compares and analyzes texts

to create new interpretations by translating

studies into one another. Noblit and Hare (1988) proposed that translating studies

involves making analogies between the studies and also among the studies. An interpretive form of knowledge synthesis is achieved inductively. The aims of metaethnography are

to enable:

1. More interpretive literature reviews

2. Critical examination of multiple accounts

of an event, situation, and so forth

Generating and Assessing Evidence for Nursing Practice (11th ed.)

408 APPENDIXL

3. Systematic comparison of case studies to draw cross-case conclusions

4. A way of talking about our work and comparing it to the works of others

5. Synthesis of ethnographic studies (Noblit

& Hare, 1988, p. 12)

= Sample

These six studies are profiled in Tables 1 and 2. In the first study, “Birth Trauma: In

the Eye of the Beholder,” I focused on the

experience of traumatic childbirth (Beck,

2004a). In the second study I examined

PTSD following birth trauma (Beck, 2004b).

In the third study I examined the anniversary

of birth trauma (Beck, 2006a). These first

three studies were phenomenological studies. The fourth study was a narrative analysis of

birth trauma stories (Beck, 2006b). The fifth

and sixth studies in my program of research were phenomenological studies looking at

the impact of birth trauma on breastfeed- ing (Beck & Watson, 2008), and on the

experience of subsequent childbirth after a

previous traumatic birth (Beck & Watson,

2010). The total number of participants in these six studies was 175 mothers. Thirty- eight of the 40 mothers who participated in

the first study on birth trauma (Beck, 2004a)

also participated in the PTSD-following-

child-birth study (Beck, 2004b). I achieved

data saturation in each study. All the studies

adhered to ethical standards. I received

institutional review board approval for each

study and informed consent was obtained from all participants.

Qualitative studies on traumatic childbirth

have been conducted by researchers other

than me, including Ayers (2007) and Nicholls

and Ayers (2007). The studies conducted

by these authors were not pertinent to the

current metaethnography and thus were not

included in it, because this metaethnography

was a synthesis of results used in a program of research by the same researcher, that being myself.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

A Metaethnography of Traumatic Childbirth and Its Aftermath

& Data Analysis

I used Noblit and Hare’s (1988) seven-step

approach for synthesizing the findings of qualitative studies. These steps overlapped

and repeated as the synthesis was conducted,

and included:

1. Choosing a phenomenon to be studied 2. Identifying which qualitative studies were

pertinent

3. Reading the qualitative studies to be

included in the synthesis 4, Deciding how the studies were related to

one another. Here the researcher lists the

key metaphors in each study and how they are related to each other. Noblit and Hare use the term metaphor to refer to concepts,

themes, or phrases when synthesizing studies. Three differing assumptions can

be made regarding how studies are related: “(a) the accounts are directly comparable as ‘reciprocal’ translations; (b) the accounts

stand in relative opposition to each other

and are essentially ‘refutational’; or (c)

the studies taken together present a ‘line of argument’ rather than a reciprocal or refutational translation” (p. 36). In this

metaethnography, the assumption was one

of reciprocal translations.

5. Translating each study’s metaphors into

the metaphors of the others, and vice versa. Noblit and Hare described these translations as “especially unique syntheses

because they protect the particular, respect

holism, and enable comparison” (p. 28).

6. Synthesizing the translations, wherein a

whole is created which is something more

than the individual parts imply. 7. Expressing the synthesis, most often

through the written word; however, plays,

art, videos, or music are other options.

Care must be taken during the data

analysis phase of a qualitative synthesis, as Sandelowski et al. warned:

Qualitative metasynthesis is not a trivial pursuit,

but rather a complex exercise in interpretation:

Carefully peeling away the surface layers of

Reprinted

with permission.

409 A Metaethnography of Traumatic Childbirth and Its Aftermath APPENDIXL =

(OL) u e a i e s a g (GZ) jeulben

(L) yi0g (GZ)

u e s i e s e d

(9z) jeurbe,

(9) y10g (€L)

U e s s e s a g

(SL) jeurben

(L) 4 0 g

(¢) u e s i e s a g

(Z) jeurbej

(Z|) u e s s e s a g

(Lz) jeulben

(QL) u e s i e s a y

(ZZ) jeubeA

(L) pasioniq (pe) pawey

(L) p a y e s e d a s

(G) 4 o u y e d

yum Bulary

(97) paluey|

(7) Buissi

(L) aj6uls (L) pad10NIq (LE)

p a l e

(LL) p a l e

(Z) ajBuis (Z) ped0aiq (ve)

p a l e

(€) aj6uis (€) ped0aiq (pe)

p e l e

(N) adAy Arantjaq

Ay de

sG ou

yj ae

ja yy

} Ul

pa pn

ya uy

Ip Ny

g je Np IA Ip Uy

ay )

Sj Ue dI DI pe Y

SO Ns a} Ie Ie Yy

Di yd es Bo wa g

| aj

qe y

(N) SM}eIS [ E e ]

(ZG) sesediyjny|p

(LE) sesediwiiig

(LZ) s e s e d i n \

(7) Buissi| (6L) s e s e d i u i i i g

(pL) sesedninyy|

(€) s e s e d i w i i g

(g) s e s e d i j n j

(ZL) Sesediwid

(9Z) s e s e d i j n

(QL) sesediuiid

(vz) sesedijni,

(N) A u e

ES SE C

vS-0e

SemIG vy-Gc

O0 v- SZ

abuey aby

(L) e p e u e d

(g) eljesisny

(9) puejesZ M e N

(g) w o p B u r y p e u

(GL) se1e1S

peyluA

(€) epeued (vy) wopbuly payun

(9)

eljesisny

(LL) Saleis paluy

(8z)

puejeaz

MeN

(L) e p e u e g

(vy) W o p b u l y

peliuq

(7) eljesisny (g) puejeaz MaN

(OZ)

se1e1S

peLluA

(L) w o p b u l y peyun

(L) ejeusny (€) puejesz

M a n

(9) se1e1s pe1lup

(€) wopBuly peyiuy

(9) eljesasny (Z) sa1eis

pewun (ZZ)

puejeez MeN (€)

wopbuly peyun

(9) eljesaisny (8) sae@1S peyuy (€Z) puejeez MEN

(N) Ayunoy

cg LE

8e Ov

(OLOZ)

uosle/\\

Q 9eq

(8 00 2)

UO s}

e/ \\

49 9g

azisg ajdwes

Ap ny

Reprinted

with permission.

410 APPENDIXL A Metaethnography of Traumatic Childbirth and Its Aftermath

Table 2 Methodological Characteristics of the Qualitative Studies Included in the

Metaethnography

Author Year Qualitative Research design Data Analysis

Beck 2004a Phenomenology Colaizzi

Beck 2004b Phenomenology Colaizzi

Beck 2006a Narrative Analysis Burke

Beck 2006b Phenomenology Colaizzi

Beck & Watson 2008 Phenomenology Colaizzi

Beck & Watson 2010 Phenomenology Colaizzi

Note. All studies had methodological characteristics of convenience sampling and Internet data collection.

studies to find their hearts and souls in a way

that does the least damage to them. Synthesists

must analyze studies in sufficient detail to pre-

serve the integrity of each study and yet not

become so immersed in detail that no useable synthesis is produced (1997, p. 370).

# Results

I constructed a detailed table of key meta-

phors from each of the six studies to facilitate

the reciprocal translations (Table 3). These

individual study metaphors were clustered

into three overarching themes: stripped of pro-

tective layers, invisible wounds, and insidious

repercussions. Under the theme of stripped of protective layers were the key metaphors that revealed that in birth trauma women perceived

they were systematically stripped of essen-

tial protective layers, leaving them exposed

and feeling very vulnerable. The overarching

theme of invisible wounds addressed both the short- and long-term distressing emotions women struggled to cope with after experi-

encing a traumatic birth, such as fear, terror, grief, and feeling like a rape victim. Included under insidious repercussions were the often invisible detrimental effects of birth trauma on mothers’ interactions with their infants.

Two of the six studies (Beck, 2004a; Beck,

2006b) included in the metaethnography

Generating and Assessing Evidence for Nursing Practice (11th ed.)

uncovered the essence of what constituted traumatic childbirth for the women. The key

metaphors in these two studies started the

devastating domino effects that permeated mothers’ lives as their dreams of motherhood

were shattered. In my phenomenological study of traumatic childbirth (Beck, 2004a),

a resounding characteristic of this phenome-

non was that, just like beauty, birth trauma was in the eye of the beholder. What women

perceived as a traumatic birth clinicians

might have been viewed as a routine, normal

delivery. Women felt abandoned, stripped of their dignity, and not cared for as an individ- ual who deserved to be treated with respect.

Obstetric staff neglected to communicate with

mothers. Women often felt invisible, as Nicole

explained:

After an hour trying to deliver the baby with a

vacuum extractor, the obstetrician said it was too late for an emergency ¢esarean. The baby was

truly stuck. By now the doctors are acting like

Pm not there. The attending physician was say-

ing, “We may have lost this bloody baby.” The

hospital staff discussed my baby’s possible death in front of me, and argued in front of me just as if

I weren’t there. (Beck, 2004a, pp. 32-33)

Some women felt their trust in their respec-

tive obstetric care provider was betrayed, because they perceived that they received

unsafe care but were powerless to rectify the dangerous situation. Mothers’ traumatic

experiences were pushed into the background

Reprinted

with permission.

411 A Metaethnography of Traumatic Childbirth and Its Aftermath APPENDIXL a ~~

(p an

ui qu

o2 )

sj yB no uy }

|e pl oi ng

B u l s s i w

ju ej u!

U U M

B u l p u o g

je uo lj ow y 9a SJ OM

49 }} 9q

JO 4

:s al ie su aA iu ue

J u a n b e s q n s

9} e1

s aj !B es y

:a nB

oj id

a a u ,

pa se yj ey us

SW UE SI G

: P O O Y J B U J O W

P] LL

OA A

éad1d

jeUuM

éasuedxa

asoumM

:sueawW ou} saisiysn{ pus ay] suoissnoseday snoipisuy

p e d e

Bu la

g ay Iq

sy oe qy us e| 4

JO sso7 IOUS

p o l l o ]

A s e s i a A i u u e

J U B W I 0 }

A e p y y i q

u o n e i g a j a o

:A ep

je nj oe

ay ,

au l}

iz iu

ob e

u y

:a nB oj oi d

a y y

p i e M u m M o p

Bu lj es id s

:u oi ss ai da p

pu e

‘A yo ix ue

‘J aB ue

O1 4]

S n o s a b u e g

a B u e u d

pu e

Al }

qu un u

OO ]

‘ j a s A W

M O p e U s

V7 o6

o w

a y e w

}, UO p

as ea

:S 8l

IA OW

9 }

B u l o y

WI JD

ad es

e ay I)

1/ 94 J O O ]

JO 1I

Je a4

sS aj

Ja Mo

ao ue

je qu

Ol je s

A o u a b e

:j ov

U O ! J E D I U N W I W O D

yO e7

B u s e s

yo re ]

an ds as

ai nj

ie 4

po ou ys eu jo w

PJ JO M

LO I}

UO !T E| OS | ye y

Y e }

e d

Bu lj ue m

pu e

pa ia

ms ue

su ol js an b

aa ey

Bu ly

aa s

S S o | J a M o d

1/ 24

| pu

e ys n4 }

A w

pa de sj aq

NO ,

:8 1e €9

aj es

9p IA

OI d

é p e j d e | G e u

si y}

s e m

A u n

“O W

Y U M

a J e d I U N W W W O D

é s e

yo nu w

OO }

JE U}

S E A

:O W

JO J

B4 e9

So Ai }e se U

e w n e s }

y g

Bu ld de |j |

: A y d e s b o w e s

o1 pe ju ad

(4 90 02 )

49 °g

anosal

au nj ie 4

:e uu ne l}

Yy ui gq

A i e s u a n i u u y

(2 90

02 )

49 9¢ q

u j y e u a y e

a y ,

“Y LI Gp |! yd

an p

GS Id

( 4 7 0 0 7 )

4 9 8 g

Ja p|

ou eg

q au }

9A e

9u y}

:e lu

Nn es

} YL ig

(2 70 02 )

49 9g

SP UN

OA A

2/ qI SI AU ]

si aA e7 ]

8A 19

9} 01

g Jo

pa dd

is ys

ni s

S S

sa wa

Gu iy

ss es

9a Q

ay }

pa ye

ja y

si oy de ja yy

Ap ny s

je np ia ip uy

¢ ay qe y

with permission.

A Metaethnography of Traumatic Childbirth and Its Aftermath APPENDIX L 412

p e b u e y s

Ja Aa u

ue d

Is eg us eq

BA PY

P| NO D

Y e Y M

10 }

B u I A

a d u a l e d x e

Bu lj ea y

JO J- pe bu o]

a y

:a Ai sn ja

| S

SN je }

ss au qu uN yy

ji ey ie

Ay dw ea

: J u s W Y o e J E p

Bu lq in is iq

JE 1u aq

J O O

pe ai q

A j o i x u y

Je a4

Ad ue ub ea id

Bu li np

a1 Ue d

B A e M

JU a| Ng in }

ay }

Bu lp iy

Ao f

pa je di oi ju e

Bu lj ea is

:s yo eq us el y

Bu lp ns ju y

s] Se 91 q

S JO YI OI /|

:P a} e/ OI A

Hu lu }

as 0w W

9a uO

Is Nr

A q e q

au }

J U s W a U O l Y y

: J e A d e

|N JM e

10 5

Bu ly ey y

Uu OI }E UI LU Ia }] Ea p

Ja ay s

-4 ay JO W

e se

}j aS

eU O

BU IA OI Yg

Y w i g

d1}ew N e

SNOIAeid e Jaye

YUIqp|I4yd J u a n b e s q n s

au oj e

Aj Bu lu ay bi s4

(O LO Z)

U O S I E M

49 9g

B u l p a a y s e a i g q

Bl un ed

Y I

jO ed Wy

(8 00 2)

Uo si eM y

49 9g

su oi ss no di ad ay

sn oi

pi su

y SP UN OA A

qI SI AU |

s1 9A e7

8} 99 }0 1g

pa dd in g

A p m s

—

C C

r r r e e e

(p an uy uo s)

¢ aj qe y

Reprinted

with permission.

Manual for Nursing Research: Generating and Assessing Evidence for Nursing Practice (11th ed.)

- APPENDIXL &

as family and clinicians celebrated the birth of a live, healthy infant.

I later examined traumatic childbirth using a different qualitative research design,

that being narrative analysis (Beck, 2006b). Using Burke’s (1969) dramatistic pentad as the structure for viewing mothers’ narratives,

his ratio imbalance of act:agency appeared prominently in the narratives. Center stage

in a woman’s birth trauma narrative was

how acts were performed during the birthing

process. The manner in which obstetrical staff

provided care to women during childbirth

demonstrated a glaring absence of caring.

The following is an excerpt from Michelle’s

narrative of the uncaring manner (agency) of the nurse who was present as the mother gave

birth to her stillborn preterm infant:

My husband went to get the nurse. The nurse

said, you have only just had the gel, you

couldn’t be having IT yet. I said, yes. She is

about to be born. The nurse checked and the

head was visible. She looked shocked and said

wait. Pll have to get a dish and returned with a green kidney shaped dish. The way she held the

dish and the look on her face, I knew she did

not want to be in the room. My husband held

the dish for her. I then gave a little push and my daughter (still in her little sack) slipped quietly in the dish. The nurse took the dish from my

husband and covered my daughter with a sheet.

She then walked off without saying a word about where she was going. I called to her.

Where are you taking her??? (I had not even

seen her properly as she was still in her sack).

The nurse said, I have to take IT to the doctor.

She wants to see IT. Also the nurse continued

to refer to me by my last name, not my first

name. I said but I want to see my daughter. She

said, Why? IT’s dead. She then said I have to

get someone to wash IT so IT can be examined.

(Beck, 2006b, p. 461)

As the metaethnography progressed and

more of the key metaphors were translated into each other, I had an “Aha!” moment.

Operating in the aftermath of birth trauma— with its domino effects on various aspects of motherhood—was amplifying causal looping. In amplifying causal looping, “as consequences become continually causes and

Reprinted

with permission.

A Metaethnography of Traumatic Childbirth and Its Aftermath 413

causes continually consequences one sees either worsening or improving progressions or escalating severity” (Glaser, 2005, fo Dy.

Causal loops involve feedback behavior in

which the effects of a change serve to inten- sify or oppose the original change. Feedback is an important concept to consider. A

change in one factor can impact another factor, which then can affect the first factor. When feedback decreases the impact of a

change, it is sometimes referred to as a bal- ancing loop. In contrast, a reinforcing loop occurs when feedback increases the impact of a change. This causal looping can amplify in either a positive or negative direction. The term positive does not necessarily mean that the changes are good; it only means that

the changes are reinforced. Negative only indicates that changes are resisted; it does not necessarily mean the effects or changes are bad.

The amplifying feedback loops that emerged from this metaethnography of

the five phenomenological studies and one narrative analysis on traumatic childbirth are

illustrated in Figure 1. A successive series of amplifying feedback loops occurred. The orig-

inal trigger of traumatic childbirth resulted in six amplifying feedback loops, four of which were reinforcing (positive direction), and two of which were balancing (negative direction).

REINFORCING LOOP #1

The first reinforcing feedback loop focused on

the detrimental effects that the posttraumatic

stress symptoms resulting from child-birth can have on mothers’ breastfeeding experiences.

When attempting to breastfeed, some women

suffered with uncontrollable flashbacks to their traumatic birth. As Molly revealed:

I had flashbacks to the birth every time I would

feed him. When he was put on me in the hospital, he wasn’t breathing and he was blue. I kept pic- turing this; and could still feel what it was like.

Breastfeeding him was a similar position as to the

way he was put on me. (Beck & Watson, 2008,

p. 234)

Generating and Assessing Evidence for Nursing Practice (11th ed.)

414 APPENDIXL ™ A Metaethnography of Traumatic Childbirth and Its Aftermath

Breastfeeding

5 R4 B2

Subsequent

B1 i 7 Mother-Infant Interaction R11 =,

Birth Trauma proton wea +

PSS/PTSD

Anniversary

Figure 1. Amplifying causal loop diagram illustrating traumatic childbirth and its aftermath R = reinforcing

loop; B = balancing loop; PSS/PTSD = posttraumatic stress symptoms/posttraumatic stress disorder.

For some mothers, these intruding flash-

backs were so distressing that they made a

decision to stop breastfeeding. Angie admit-

ted that, “The flashbacks to the birth were

terrible. I wanted to forget about it and the pain, so stopping breastfeeding would get me

a bit closer to my ‘normal’ self again” (Beck

& Watson, 2008, p. 234).

Avoidance of triggers to the recollection

of the original trauma, in this case trau-

matic birth, permeated mothers’ lives. Their

infants were constant reminders of their birth trauma. For some mothers, feeling detached from their babies and distancing themselves

from this trigger hindered their breastfeeding. Rachael shared,

Breastfeeding my son in the first few months,

certainly the first 6 but possibly as much as 9

months, was an empty affair. I felt nothing at all.

Breastfeeding was just one of the many things I

did while remaining totally detached from my baby. (Beck & Watson, 2008, p. 234)

Nancy, who had an emergency cesarean birth under general anesthesia, revealed, “I

didn’t feel like a real mother, as I was unable

to give my daughter a normal birth. I felt very disconnected from this baby as I breastfed

her” (Beck & Watson, 2008. p. 235).

Women traumatized during childbirth often felt like victims of rape: violated and

stripped of their dignity. Hypervigilance is one of the clusters of symptoms of posttraumatic stress. Some women became vigilant about

protecting their bodies from being violated yet again. This hypervigilance focused on their breasts and hindered their breastfeeding. Jeanne, whose labor had been induced and

who had a failed vacuum extraction followed by a cesarean birth, shared the following:

When I breastfed my baby, I felt like it was one

more invasion up on my body and I couldn’t han-

dle that after the labor I had suffered. Whenever

I put her to breast, I wanted to scream and vomit

at the same time. (Beck & Watson, 2008, p. 233)

a APPENDIXL &

In the following comment Leslie was refer-

ring to the staff in the neonatal intensive care unit who were trying to help her breastfeed her preterm infant: “I was sick of everyone

grabbing my breasts like they didn’t belong to me. My breasts were just another thing to be

taken away and violated” (Beck & Watson,

20085 p21 233') In this first amplifying causal loop the

posttraumatic stress symptoms of birth

trauma had a positive (reinforcing) effect

on breastfeeding experiences, which in turn intensified women’s distress and posttrau-

matic stress symptoms, creating a vicious

cycle of trauma and distress.

BALANCING LOOP #1

The first balancing loop, like the first rein- forcing loop, involved the feedback between posttraumatic stress and breastfeeding. In this causal loop, some factors related to breast- feeding opposed the original effects of post- traumatic stress from birth trauma and helped

to diminish these distressing symptoms. One

of the themes in my phenomenological study with Watson (2008) on the impact of birth

trauma on breastfeeding was “Helping to

heal mentally: Time out from the pain in one’s head.” For some women, breastfeeding helped to heal them. Soothing was a term used by some mothers to describe breastfeed- ing. Karen, who had experienced a terrifying

postpartum hemorrhage, explained:

Breastfeeding was a timeout from the pain in my

head. It was a “current reality’—a way to cling

onto some “real life,” whereas all the trauma

that continued to live on in my head belonged to

the past, even though I couldn’t seem to keep it

there. (Beck & Watson, 2008, p. 233)

REINFORCING LOOP #2

This second reinforcing causal loop involved the feedback between posttraumatic stress following childbirth and mother-infant interaction. This positive amplifying loop

Reprinted

with permission.

A Metaethnography of Traumatic Childbirth and Its Aftermath 415

was operating in all the studies included in this metaethnography. In my study on PTSD resulting from childbirth (Beck, 2004b), a

disturbing theme revealed that posttraumatic stress choked off lifelines to the world of motherhood. Women’s dreams of how moth-

erhood would be were shattered. With PTSD,

some women distanced themselves from their

infants. Their infants were triggers to inten-

sifying their posttraumatic stress symptoms, such as flashbacks and nightmares. As Linda described,

At night I tried to connect/acknowledge in

my heart that this was my son, and I cried. I

knew that there were great layers of trauma

around my heart. I wanted to feel motherhood.

I wanted to experience and embrace it. Why was

I chained up in the viselike grip of this pain?

(Beck, 2004b, p. 222)

The disturbing detachment from their

infants of mothers suffering with posttrau- matic stress symptoms was confirmed in the

breastfeeding study (Beck & Watson, 2008). In the anniversary-of-birth-trauma study

(Beck, 2006a), some mothers revealed that

the traumatic effects of birth left them feeling like they were not real mothers, and that an emotional bond with their infants was miss- ing. Debbie recalled the following about her

child’s first birthday:

I wanted to die. I felt nothing for her and found it hard to celebrate the joy of this child that

meant so little to me. I took excellent care of

her, but it was as if I was babysitting; the emo-

tional bond just wasn’t there. (Beck, 2006a,

p. 386)

From the subsequent childbirth-after- previous-traumatic-birth study results (Beck

& Watson, 2010), we now are privy to the

reinforcing effect—this time the effect on mother-fetus bonding. During their preg- nancies women experienced terror, panic,

and fear as they waited for 9 months for the dreaded labor and delivery. Some women turned to denial of their pregnancy to “sur-

vive” this period. Laurie shared that, through- out her pregnancy, she “felt numb to my

baby” (p. 245).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

416 APPENDIXL =

REINFORCING LOOP #3

The third reinforcing feedback loop in this meta-ethnography concerned the anniversary-

of-birth trauma (Beck, 2006a). Feedback

from the yearly anniversary increased the

impact of the post-traumatic stress symptoms

and amplified distress in mothers. It was not just the actual day of the anniversary that amplified this distress, but also the prologue

of weeks and sometimes months leading up to

the anniversary of traumatic birth. Fear, grief,

anxiety, dread, depression, and guilt were

just some of the distressing emotions women

struggled with as the anniversary approached.

The calendar, seasons, and clock times were

all triggers to flareups of posttraumatic stress symptoms. Anna, whose birth trauma

occurred near Halloween, explained:

There is also a distinct smell of dead leaves in the air that screams, “October!” Hearing the

word, October, and seeing the word in writing gives me chills. When I would see decorations

for Halloween, fear rushed through my body. (Beck, 2006a, p. 385)

Women also struggled with the actual day:

Was it a celebration of their child’s birthday, or the torment of an anniversary? The birth-

day of Shannon’s child triggered the following

flashback of this mother’s emergency cesarean

birth: “I can’t stop seeing images of a woman

drugged and strapped down and being gutted

like a fish. I can’t get those or my own images

out of my mind. I didn’t know how to celebrate

my daughter’s birthday” (Beck, 2006a, p. 386). Women often paid a heavy toll as a result

of their surviving the actual anniversary. One

of the themes in my phenomenological study

(2006a) was “The epilogue: A fragile state.” Mothers vividly shared how they felt at anni- versary time, as the invisible wounds from their traumatic births were reopened. Women

needed time to heal their raw wounds. Christine described this reinforcing effect:

As hard as | try to move away from the trauma,

at birthday anniversary time I am pulled straight

back as if on a giant rubber band into the midst of

it all and spend MONTHS AFTER trying to pull

myself away from it again (Beck, 2006a, p. 387).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

A Metaethnography of Traumatic Childbirth and Its Aftermath

REINFORCING LOOP #4

Results of the phenomenological study of sub-

sequent childbirth after a previous traumatic birth (Beck & Watson, 2010) provided data

upon which the fourth reinforcing causal loop was based. During pregnancy, women rode a

turbulent wave of panic and other distressing emotions as their posttraumatic stress symp-

toms increased in intensity. Nicole revealed

the following about the entire period of her pregnancy: “My 9 months of pregnancy were

an anxiety filled abyss which was completely marred as an experience due to the terror that was continually in my mind from my experi-

ence 8 years earlier” (Beck & Watson, 2010,

p. 245). Women employed numerous strategies

during pregnancy to break the reinforcing cycle of one traumatic birth followed by another traumatic birth. Examples of various

strategies include exercise, yoga, relaxation

techniques, keeping a journal, hypobirthing (a method of natural childbirth using relax- ation and self-hypnosis to eliminate fear and

tension), reading about the birth process, and creating birth-oriented art. Sadly, for some women, their longed-for healing birth experience remained elusive. The amplifying

feedback loop was reinforced. An example

of one such instance of this positive feedback was from Carol, who had opted for a home- birth. Because of postpartum hemorrhage she

had to be transported by ambulance to the hospital, all the while terrified she would not live to raise her baby. She vividly described

her experience on the operating table:

With my legs held in the air by two strangers

while a third mopped the blood between my

legs, I felt raped all over again. I wanted to die.

I had failed as a woman. My privacy had been

invaded again. I felt sick. (Beck & Watson, 2010, p. 247)

BALANCING LOOP #2

Three fourths of the women in my (2010) study

with Watson described that their subsequent

Reprinted

with permission.

fa APPENDIXL #

childbirth was a “healing experience,” or at least “a lot better” than their prior traumatic

birth had been. The second balancing feedback loop captures this opposing change to the feed- back loop. A reverence was brought to their subsequent birthing processes, and the women felt empowered. What helped to initiate this balancing feedback loop? Some reasons moth- ers gave included (a) being treated with respect, dignity, and compassion; (b) having pain relief

taken seriously; (c) improved communication

with labor and delivery staff; and (d) not

feeling rushed to deliver. Kathryn described this negative (balancing) feedback loop:

It was as healing and empowering as I had always hoped for. I did not want any high tech man-

agement. My homebirth was the proudest day

of my life and the victory was sweeter because

I overcame so very much to come to it (Beck &

Watson, 2010, p. 247).

@ Discussion

Leverage points identify where pressure in the

amplifying causal loop can produce desired

outcomes, namely breaking the feedback loop where necessary (Newell, Proust, Dyball,

& McManus, 2007). Obviously, with birth

trauma, the ideal intervention is to prevent it, to treat each woman during the birthing process as if she were a survivor of previous trauma (Crompton, 2003). Highley and Mercer (1978) expressed it best, as they

reminded clinicians of the reverence that needs to be provided to women in labor:

Being able to assist a woman in one of the greatest

tasks of her life—giving birth to and mothering a

baby—is a privilege and challenge that touches

every nurse who assists in her care. The challenge

extends not only to the concrete physical help

that the mother needs, but to the subtle consider-

ation and attention which help her maintain her

self-control and thus her self-respect. (p. 41)

The panoramic view provided by this meta- ethnography (see Figure 1) clearly illustrates the multiple, repetitive, reinforcing, amplifying

Reprinted

with permission.

A Metaethnography of Traumatic Childbirth and Its Aftermath 417

causal loops that permeate mothers’ lives as they struggle with the long-term aftermath of traumatic childbirth. Four of the six ampli- fying loops are reinforcing, thus intensifying

posttraumatic stress symptoms in mothers. Leverage points abound for interrupting these

positive amplifying causal loops. Clinicians fail to rescue women with birth trauma time and

time again: during breastfeeding, during their interactions with their infants, during yearly

anniversaries, and in subsequent childbirth.

Many precious opportunities to balance these

causal loops are lost. Obstetric care providers need to ensure that women are surrounded with protective layers during the birthing

process. These protective layers include feeling

cared for, being communicated with, being treated with respect and dignity, allowing some

control when appropriate, supporting women, and providing assurance.

To help prevent the four reinforcing causal

loops from coming into play, clinicians need to be vigilant in observing women for any symptoms indicating that they might have

experienced a traumatic birth. Instruments are

available to screen women in the postpartum

period for posttraumatic stress symptoms.

One such instrument is the Post-Traumatic Stress Symptoms Scale (Foa, Riggs, Dancu & Rothbaum, 1993). If women screen positive for elevated symptom levels, referrals to mental health professionals can be made. Treatment

options, such as eye movement desensitization

reprocessing, have been shown to be effective in women with posttraumatic stress symptoms

resulting from traumatic childbirth (Sandstrom,

Wiberg, Wikman, Willman, & Hogberg, 2008).

Regarding Reinforcing Loop #1, an exam-

ple of one leverage point is providing intensive oneon-one support for traumatized women as they initiate breastfeeding. For the second

reinforcing loop, periodic routine assessment

of mother- infant interactions during the postpartum period can be one leverage point.

These assessments can provide an opportunity

to identify women struggling with posttrau-

matic stress symptoms.

Yearly physical exams for children provide

a golden opportunity for clinicians to try and

Generating and Assessing Evidence for Nursing Practice (11th ed.)

418 APPENDIXL

interrupt Reinforcing Loop #3. At these well-

child checkups, mothers should also be the focus of health care providers. Women need to be asked if they are struggling around the yearly anniversary of their children’s birth.

Leverage points to address Reinforcing

Loop #4 can and should occur throughout

the 9 months of pregnancy. If a woman is

a multipara, an essential component of her initial prenatal visit should be a discussion of the mother’s perception of her previous births. Were any of these births perceived as traumatic births? England and Horowitz (1998) urged clinicians to encourage wounded mothers to grieve their prior traumatic births so as to lift the burden of their invisible pain. To try and prevent another traumatic birth,

clinicians can share with women the strategies

other mothers used (Beck & Watson, 2010).

Some of the amplifying causal loops discovered in this metaethnography con-

firmed results reported in qualitative studies

conducted by other researchers. For example,

Reinforcing Loop #2, mother-infant inter-

actions, supported findings from Nicholls and Ayers’ (2007) study of PTSD in six

couples. The women commented on poor bonding with their infants, “putting on an act” with their babies because they did not

have any positive feelings toward their babies. Overprotective/anxious bonding and avoid- ant/rejecting bonding were reported by these mothers.

The essence of what constituted traumatic

childbirth identified in this metaethnography confirmed results of previous qualitative stud- ies. For example, in Ayers’ (2007) study with

25 mothers with posttraumatic stress symp-

toms, women used adjectives like panicky,

alarmed, scared, and helpless to describe their

traumatic births. Some mothers shared that they dissociated and had thoughts of death during labor.

Ideas for further research can be gleaned from this metaethnography. Some of the

“domino effects” of traumatic childbirth

are apparent from this synthesis, but more

qualitative research can be conducted to discover what other insidious effects of birth

Generating and Assessing Evidence for Nursing Practice (11th ed.)

A Metaethnography of Traumatic Childbirth and Its Aftermath

trauma permeate women’s lives. For example,

are mothers’ interactions with their older children also affected? Additional research to identify more balancing feedback loops is also warranted. Since all six studies included

in this metaethnography were conducted via the Internet, replication of these qualitative studies with non-Internet samples is needed.

The reinforcing amplifying feedback loops discovered in this metaethnography provide compelling evidence to help bring visibility to this mostly invisible phenomenon. A mother in one of my studies (Beck, 2004b) said it

best when describing her PTSD following child-birth: “It’s like an invisible wall around the sufferer” (p. 221). In the recent United

States national survey, Listening to Mothers

II, 9% of new mothers screened positive for meeting the DSM-IV (American Psychiatric

Association, 2000) criteria for a diagnosis of

PTSD following childbirth (Declercq, Sakala, Corry, & Applebaum, 2008). The qualitative results of this metaethnography of traumatic childbirth “put the flesh on the bones” of this sobering quantitative statistic of the state of new mothers in the United States (Patton,

1990).

Declaration of Conflicting Interests

The author declared no conflicts of interest with

respect to the authorship and/or publication of

this article. Funding

The author received no financial support for the

research and/or authorship of this article. Bio

Cheryl Tatano Beck, DNSc, CNM, FAAN, is

a distinguished professor at the University

of Connecticut School of Nursing in Storrs, Connecticut, USA.

Corresponding Author: Cheryl Tatano Beck,

University of Connecticut School of Nursing, 231

Glenbrook Road, Storrs, CT 06269-2026, USA

Email: [email protected]

REFERENCES American Psychiatric Association. (2000). Diagnostic

and statistical manual of mental disorders (4th ed.).

Washington, DC: Author.

Reprinted

with permission.

- APPENDIXL

Ayers, S. (2007). Thoughts and emotions during trau- matic birth: A qualitative study. Birth, 34, 253-263. doi:10.1111/).1523-536x2007.0018.x

Beck, C. T. (2004a). Birth trauma: In the eye of

the beholder. Nursing Research, 53, 28-35. doi:10.1097/00006199-200401000-00005

Beck, C. T. (2004b). Post-traumatic stress disorder due

to childbirth: The aftermath. Nursing Research, 53, 216-224. doi:10.1097/00006199-200407000-00004

Beck, C. T. (2006a). The anniversary of birth trauma:

Failure to rescue. Nursing Research, 55, 381-390. doi:10.1097/00006199-200611000-00002

Beck, C. T. (2006b). Pentadic cartography: Mapping birth trauma narratives. Oualitative Health Research, 16, 453-466. doi:10. 1177/1049732305285968

Beck, C. T, & Watson, S. (2008). Impact of birth

trauma on breastfeeding: A tale of two pathways. Nursing Research, 57, 228-236. doi:10.1097/01. nnr.0000313494.87282.90

Beck, C. T, & Watson, S. (2010). Subsequent

childbirth after a previous traumatic birth. Nursing Research, 59, 241-249. doi:10.1097/ nnr.06013e3181e501 fd

Burke, K. (1969). A grammar of motives. Berkley, CA: University of California Press.

Crompton, J. (2003, summer). Post-traumatic stress

disorder and childbirth. Childbirth Educators New Zealand Education Effects, 25-31.

Applebaum, B. O. (2008). New mothers speak out: National survey results highlight women’s postpartum experiences. New York: Childbirth

Connection. Retrieved from Childbirth Connection

Web site at http://www.childbirthconnection.org/ listeningtomothers/

Draucker, C. B., Martsolf, D. S., Ross, R., Cook, C. B., Stidham, A. W., & Mweemba, P. (2009). The

essence of healing from sexual violence: A qualitative metasynthesis. Research in Nursing & Health, 32, 366-378. doi:10.1002/nur.20333

Duggleby, W., Holtslander, L., Kylma, J., Duncan, V., Hammond, C., & Williams, A. (2010). Metasynthesis of the hope experience of family caregivers of persons with chronic illness. Oualitative Health Research, 20, 148-158. doi:10.1177/1049732309358329

England, P., & Horowitz, R. (1998). Birthing from within. Albuquerque, NM: Partera Press.

Fleming, E., & Gillibrand, W. (2009). An exploration

of culture, diabetes, and nursing in the South Asian

community. Journal of Transcultural Nursing, 20, 146-155. doi:10.1177/104365 9608330058

Foa, E. B., Riggs, D. $., Dancu, C. V., & Rothbaum, B.

O. (1993). Reliability and validity of a brief instru- ment for assessing posttraumatic stress disorder (PSS-SR). Journal of Traumatic Stress, 6, 459-473.

doi:10.1002/jts.2490060405 Glaser, B. G. (2005). The grounded theory perspective III:

Theoretical coding: Mill Valley, CA: Sociology Press.

Reprinted

with permission.

A Metaethnography of Traumatic Childbirth and Its Aftermath 419

Glaser, B. G. (2007). Doing formal grounded theory: A proposal. Mill Valley, CA: Sociology Press.

Glaser, B. G., & Strauss, A. L. (1971). Status passage. Chicago: Aldine-Atherton.

Highley, B., & Mercer, R. T. (1978). Safeguarding

the laboring woman’s sense of control. MCN: The American Journal of Maternal Child Nursing, 4, 39-41. doi:10.1097/00005721-197801000-00013

Kearney, M. H. (2001). New directions in grounded formal theory (pp. 227-246). In Schreiber, R. S. & Stern, P. N. (Eds.), Using grounded theory in nurs- ing. New York: Springer.

Larsen, J. S., Hall, E. O. C., & Aagaard, H. (2008).

Shattered expectations: When mothers’ confidence in breastfeeding is undermined—A metasynthe- sis. Scandinavian Journal of Caring Science, 22, 653-661. doi:10.1111/}.1471-6712.2007.00572.x

Meeker, M. A., & Jezewski, M. A. (2009).

Metasynthesis: Withdrawing life-sustaining treatments. The experience of family decision- makers. Journal of Clinical Nursing, 18, 163-173. doi:10.111/}.1365-2702.2008.02465.x

Newell, B., Proust, K., Dyball, R., & McManus, P.

(2007). Seeing obesity as a systems problem. NSW

Public Health Bulletin, 18, 214-218. doi:10.1071/

nb07028

Nicholls, K., & Ayers, S. (2007). Childbirth-related

posttraumatic stress disorder in couples: A qualita- tive study. British Journal of Health Psychology, 12, 491-509. doi:10.1348/135910706x120627

Noblit, G. W., & Hare, R. D. (1988).

Metaethnography: Synthesizing qualitative studies. Newbury Park, CA: Sage.

Paterson, B. L., Thorne, S. E., Canam, C., & Jillings,

C. (2001). Meta-study of qualitative health research. Thousand Oaks, CA: Sage.

Patton, M. Q. (1990). Qualitative evaluation and

research methods. Newbury Park, CA: Sage. Sandelowski, M. (1995). A theory of the transition

to parenthood of infertile couples. Research in Nursing & Health, 18, 123-132. doi:10:1002/ nur.4770180206

Sandelowski, M., & Barroso, J. (2007). Handbook

for synthesizing qualitative research. New York:

Springer. Sandelowski, M., Docherty, S., & Emden, C. (1997).

Qualitative metasynthesis: Issues and techniques. Research in Nursing & Health, 20, 365-371. doi:10.1002/(sici)1098-240x(199708)

Sandstrom, M., Wiberg, B., Wikman, M., Willman, A. K., & Hogberg, U. (2008). A pilot study of eye movement desensitization and reprocessing

treatment (EMDR) for post-traumatic stress after

childbirth. Midwifery, 24, 62-73. doi:10-1016/j.

midw.2006.07.008 Thorne, S., Jensen, L., Kearney, M. H., Noblit, G., &

Sandelowski, M. (2004). Qualitative metasynthe- sis: Reflections on methodological orientation and

ideological agenda. Qualitative Health Research, 14,

1342-1365. doi:10.1177/1049732304269888

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

INCREASING GOLORECTAL

CANCER SCREENING USING

A Q1 APPROACH Diane Hountz e Jennifer Coddington ¢ KarenJ.Foli ¢

Janet Thorlton

> Abstract: According to the American Cancer

Society, 1 in 23 Americans will be diagnosed

with colorectal cancer (CRC) in their lifetime.

Screening for CRC is an effective, yet underused

preventive approach. This is especially true in

rural areas, where only 35% of patients were

found to be up to date on their screenings in

2014. Increasing CRC screening can produce pos-

itive patient outcomes by early recognition and

removal of precancerous polyps. The purpose

of this project was to use quality improvement

(QI) interventions to increase CRC screening

rates at a nurse-managed clinic in rural Indiana.

Using Deming’s Plan-Do-Study-Act O! model,

multiple interventions were implemented which

resulted in a 37% Increase in the number of

screenings ordered on eligible patients and an

overall increase of 28% in the completion of the

screenings. This project contributes to health-

care quality knowledge by also suggesting that

the fundamental principles of encouraging staff

feedback to gain buy-in, improving processes

informed by patient data, and valuing frequent

performance feedback to staff, strengthened this

QI project and ensured adoption and sustainabil- ity of these results.

> Key Words: colorectal cancer - screening - preven-

tive care - quality improvement - nurse-managed

health - clinics - nurse led

@ Introduction

Colorectal cancer (CRC) is the third most com-

mon type of cancer in men and women in the

United States and is the second leading cause of cancer-related deaths in the United States.' In 2016, more than 134,000 new cases of CRC

will be diagnosed with more than 49,000 of these resulting in a patient death.” Individuals

with Stage 1 CRC have a 92% S-year survival

rate when detected and treated; however,

only 39% of these individuals are diagnosed

at Stage 1.* With early detection through

screening procedures, CRC can be prevented

or treated sooner with increased potential for positive patient outcomes.

Colorectal cancer screening modalities are widely available throughout the United States and can detect early-stage cancer and adeno-

matous polyps.° For average risk individuals,

the U.S. Preventive Services Task Force rec-

ommends CRC screening to begin at age 50 and continue until age 75 years, and to begin at age 40 for those adults with a high risk for CRC.* National benchmarks recommend that at least 70% of all adults aged 50 to 75 be screened for CRC.

Recommendations are for CRC screening to be accomplished by either colonoscopy

420 Reprinted with permission from Hountz, D., Coddington, J., Foli, K. J., and Thorlton, J. (2017). Increasing colorectal cancer screening using a quality improvement approach in a nurse-managed primary care clinic. Journal for Healthcare

Quality, 39(6), 379-390.

- APPENDIX M @

or fecal immunochemical tests (FITs).°4

Colonoscopy is the gold standard in CRC screening and can be performed every 10 years if the screening is negative. It is an

invasive procedure that allows for direct

visualization of the colon, and the physician is able to remove polyps if discovered during the procedure. The FIT is a noninvasive test that relies on the individual to collect a stool sample to send in to the laboratory and is recommended annually if negative. If the FIT

is positive, a colonoscopy is recommended

to identify and remove any adenomatous polyps.*°

PURPOSE

Although screening rates have increased overall in recent years, the rates for patients

seen at Federally Qualified Health Clinics

(FQHCs) remain around 35% (Figure 1).’

The purpose of this project was to use a qual- ity improvement (QI) approach to increase

CRC screening rates in a rural FQHC nurse-

managed health clinic (NMHC). The goals of

this project were to

e Review the current CRC screening process

used at the NMHC. ¢ Develop interventions based on results.

Increasing Colorectal Cancer Screening Using a OI Approach 421

¢ Implement QI interventions to improve the process.

¢ Evaluate the progress of the interventions implemented.

¢ Sustain process changes.

BACKGROUND

In the United States, office-based primary care medicine is the foundation of the health-

care system. Nurse-managed health clinics

are one of the venues that provide primary

healthcare in medically underserved rural and urban areas.® Nurse-managed health clinics

are clinics operated by nurses and use nurse practitioners (NPs) as primary care providers.

These clinics face challenges to provide high-

quality, patient-centered care with limited

financial resources while trying to contin-

uously improve preventive screening rates through QI initiatives, (e.g., CRC screening).

Currently there are more than 250 NMHCs operating throughout the United States with

2.5 million patient visits per year.” Many NMHCs operate in geographic areas with

health professional shortages and provide

care to low-income and minority individuals, where the primary sources of payment are Medicaid, Medicare, private, and federal

grants.”

NMHCin Indiana (2014) i 33°.

FQHCs (2014) i 35%

indiana (2004) ry 52°

Us 2) rm <2:

Healthy People 2020 Target Fae Oe Sata) i ec nS oe eae 70%

0% 10% 30% 40% 50% 60% 70% 80%

Figure 1. Comparison of colorectal cancer screening rates. FOHC = Federally Qualified Health Clinic;

NMHC = nurse-managed health clinic.

Reprinted

with permission.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

422 APPENDIX M

REVIEW OF LITERATURE

Barriers. Low rates of CRC screening are

a complex problem involving patients, providers, and healthcare systems. Barriers

reported for underserved or low-income

patients include lack of knowledge on

importance of screenings, language barriers, fear of the screening procedure,

suffering as a result of the procedures, lack of insurance coverage, and low literacy levels.'°!! Additional barriers, specific to

colonoscopies, reported were the lack ef time, scheduling issues, bowel preparation time

and discomfort, and lack of transportation.

Fecal immunochemical test-specific barriers included being too busy, problems keeping

track of cards, and not remembering to mail

cards back.” Healthcare system barriers include

the inability to provide colonoscopies for

patients with a positive FIT due to lack of

insurance, lack of time during patient visit,

lack of transportation, lack of insurance coverage, and lack of an electronic health record (EHR) tracking system.'°!"!° A lack

of physician/provider recommendation for

CRC screening was a common healthcare

system barrier in FQHCs, resulting in low

screening rates.!*19

Interventions to Increase Screening

Rates. Numerous approaches to increase

CRC screening rates have demonstrated

small increases. Menon et al’® used tailored

telephone education and observed a 23%

increase in colonoscopy and FIT rates

among patients. Tailored navigations

through a CRC screening booklet and

materials, matched patient preferences

for screening, increased screening rates by 6.5% over nontailored interventions.

Client reminder postcards yielded a 16% increase in CRC screenings.'® Lasser et

al'? found patient navigators increased the CRC screening rates at clinics by

13.6%. Hendren et al” used a multifaceted approach through letters, automated

phone calls, and mailed FIT kits, netting a

Increasing Colorectal Cancer Screening Using a Ol Approach

21% increase in screening rates. Provider

recommendation was found to increase ; ; 14 screening rates in one study by 34%.

@ Methods

Increasing quality of care outcomes in settings

involves a problem-solving and iterative approach. The Deming Plan-Do-Study-Act

(PDSA) Framework, when applied to sys-

tems problems, is shown to improve morale,

organizational effectiveness, and efficiency,

whereas reducing costs.*! Throughout this

process, the PDSA model emphasized staff input as an integral process for ensuring

buy-in and success of any QI project.”

Therefore, this model was selected as a guid- ing framework for this project.

SETTING

The setting used for this QI project is a NMHC that provides primary care to patients

in medically underserved, rural areas of Indiana. A QI committee serves to assess,

implement, and monitor all QI initiatives.

In 2015, clinic NPs saw more than 3,212

patients, with more than 8,500 patient

encounters. About 50% of patients seen are

at 100% or above the poverty level. This NMEC received full recognition in 2014 as a Level Two Patient-Centered Medical Home

provider. To ensure financial viability, ongo- ing reporting and improvement of quality of care measures had been in place for the past 15 years. One of these measures was CRC screenings. A summary of the PDSA methods

used to address each of the five main goals of the project are summarized in Table 1.

INSTITUTIONAL REVIEW BOARD APPROVAL

Our University’s Institutional Review Board

approved this study in April 2015 (IRB study number 1504015943).

Reprinted

with permission.

423 Increasing Colorectal Cancer Screening Using a QI Approach APPENDIX M

‘q uo ua ao sd ua r

Au ye nb

= [O C

A o y - A p n j s - o q - u r j g

= y S d d

S o u o n n o v s d

as mu

g n

‘o ru lp o

ya ea y

pe se

ur us

-o si

= O H I W I N

‘ 9 9 0 k

[e ID

9I OT

= D Y D

* S J O U M O

SS B8 00 Jd

Ys I|

qe }s

y p V

‘ s o B u e u o

“O HI IN

A j y Z U O W

Ja pi Ao id

ey ep

1s 0g

p y

ss a9 0i d

‘p ap ae u

j e s

UO I} EO Np s

ap iA

oi d

an ul ju OD

9L Oo z

A e W w - | d y

p y

ul ey sn s

° ‘s is Aj eu e

p u e

u o s i s e d w o d

e j e p j s o d

pu e

ai d

p a j a j d w o y

A p n i s

u o l j e j U d W a | d u i } s O d

s y J u O W

Z S U e Y D

QO Z

MA IA

BA II

Da ds

SO 11

A p n i s

‘ p o j u a w e | d u !

sJ ap iA oi d

SU O! ]U BA J9 4U I

JE NP IA !p u!

sb ul pu yy

ju as

pu e

ji pn e

e y o

Aj ;y ae mI G

p a w O p e g

9L OZ

YN PI

AI -9

L0 Z

Ge 4

A p n i s

9y }

aJ en

je Aq

"S aS s9 90 1d

M a u

}e }S

p a j e o n p a

pu e

su ol }s an b

p a s a m s u y ’

“O HI NI N

pa js od

pu e

ss ap iA oi d

JU aS

Pu e

ej ep

p a j i d w o g

‘y oe

qp ss

d 10

} SA ap IA oi d

JE NP

IA Ip

sH ul pu lj

Ju ss

pu e

s} ip ne

e y o

A p j a e m

p a u U O p a d

g LO Z

A l e n i q a 4 — s 1 o z

9 0

o q

“S UO I] JU DA IO JU I

Pp al jI pO lW

pu e

SU O! UB AJ a} U! I

P a s o d o i d

YO eQ

Gp ad

y Jj

ye }s

p a u l e l q o

*s so 00 id

8U }

B A O I G W !

"S UO I] JU DA JO UI

SU OI ]U SA J9 }U I

p e s o d o i d

pu e

ej ep ai d

B u l j a a w

j e s

Jy ei s

p a y e o n p y

GL OZ

4 8 9 0 1 9 9

J U s W A | d U ]

“¢

‘J ua Wd oO |a Ae p

UO !]

UB AJ

e] U!

e d e y s

sa ul

ja pi

je oi ul jo

pu e

“S UO I] JU BA J9 }U I

‘O AN JE 19 II |

M A I N A

‘S MA IA JO }U !

Jy ey s

‘e Je pa id

WW O1 J

S W a | q o i d

pa ss ,

=G LO Z

a q w a j d a s — i s n B b n y

ue ld

d o j a a a q

"S W9 a| qo sd

U O e d y I U a p !

Y I M

eJ ep

UO l} Ud AJ a} UI aI d

p a z A j e u y

u e d

“ O H I I N

J S

as in u

pa sa j} si Ba s

pu e

Sq N

SM aI

AJ Ol

|E WI

OJ U|

J e q u i a } d e s - j s n b n y

ue ld

Ue ld

‘s eu lj ap in 6

a o i o e s d

Ju es

in d

pu e

ai nj es a} !|

J U B U I I a d

p a m a l A a y

ue id

so o0

oi d

“ B 9 W I W W O D

D H I N N

W o 4

je ob

j e u o n e z i u e b i o

p a u l e i q g

ue ld

Bu lu sa so s

S U P Y D

00 Z

MS IA SI

W e Y D

BA ID

Ed sO

Jj oY

y d e w

Mo |}

ss ed 0i d

d o j a n s q

J H 9

JU ua

sI Nd

‘s

s9 00

Bu lu ee s9 s

Y D

JU aI

IN D

p a u l w a j e g

GL oz

Ai nr —A e; w

ue ld

BU ]

M A I A B Y

“|

$y se

} j9 al 01 g

S w W e s a U ]

yi om

aw e.

y je oy

VS Qd

Generating and Assessing Evidence for Nursing Practice (11th ed.)

_ — _ — — —

M A I M A Q

Sp oy js |]

JU aW aA OI dU

A E N

| a1 qe ]

Reprinted

with permission.

424 APPENDIXM &

= Results

GOAL 1: REVIEW THE CURRENT CRC SCREENING PROCESS

A comprehensive assessment of the current

CRC screening process was completed. Input

was given by all staff involved in the process (i.e., NPs, nurses, medical assistants, admin-

istration, QI committee). The QI committee

previously established a CRC screening rate

goal of 70% for patients aged 51-74. The NMHC is required by Health Resources and

Services Administration to monitor, improve,

and report different quality initiatives through Uniform Data Sets (UDS) measures. The UDS

measurement for CRC screening is from age

51 to 74, so was decided to keep this consis-

tent with monitoring and reporting for these requirements. During May-July 2015, a ret-

rospective review of 200 medical records was conducted for this population. All patients

between ages of 51 and 74 who were seen and treated for a medical condition by a NP

at the NMHC were included. Patients who

were less than 51 years or greater than 74

years and those patients who were not seen or treated by a NP were excluded from the

record review.

Data points were then entered into the

Research Electronic Data Capture (RED-Cap)

database. Of the 200 charts reviewed, 76

(38%) had either screenings ordered by the

provider or were up to date with screenings (see Table 2 for CRC screening definitions).

In addition, 60 of the 200 charts (30%) had

Increasing Colorectal Cancer Screening Using a QI Approach

their screenings ordered by the provider and

completed by the patient or were up to date

with their screenings. Of those charts with no screenings ordered, only 5 (4%) indicated a

patient refusal. Data were analyzed to illuminate problems

with existing processes and guide semistruc-

tured staff interviews with the researcher.

These interviews revealed process strengths

and weaknesses, along with proposed inter-

ventions for overcoming the problems with

the screening process (Table 3).

GOAL 2: DEVELOP INTERVENTIONS BASED ON FINDINGS

Six interventions were developed using an

iterative, multifaceted approach, considering

stakeholder input, current practice guidelines,

and pertinent literature.

GOAL 3: IMPLEMENT QI INTERVENTIONS TO IMPROVE THE PROCESS

We began by educating the clinic staff in

a meeting. An overview of the problem,

project goals, and proposed interventions

were presented. Interventions were modified

based on staff feedback through informal

discussions and email correspondence.

To improve overall CRC screening rates, ongoing communication with the NMHC

staff during the first few weeks of the imple-

mentation was critical to support successful

interventions.

Table 2 Colorectal Cancer Screening Process Definitions

Colorectal cancer screening process term Definition

Screening ordered

Screening up to date

Screening completed

FIT = fecal immunochemical test; NP = nurse practitioner.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Colonoscopy or FIT was ordered by the NP.

Patient had colonoscopy within past 10

years or FIT within past 1 year

Patient completed screening procedure

(colonoscopy or FIT)

Reprinted

with permission.

- APPENDIXM ™ Increasing Colorectal Cancer Screening Using a QI Approach 425

Table 3 Problems Identified and Quality Improvement Interventions Completed

Problem Intervention

1) Lack of defined CRC screening

protocol

2) Inefficient process for ordering FIT

Protocol/algorithm for CRC screening posted at

nursing stations and given to all providers.

Simplified FIT ordering process in EHR to

allow NPs to order FIT at same time as other

laboratories and support staff to split orders to

print requisitions to be sent home with patient.

Clinical decision support tools (pop-up reminders

in EHR) to NPs on patients who are eligible but

not up to date on screenings.

Outstanding FITs will be queried monthly and

letters sent to all patients with outstanding FIT.

Educational brochure on colonoscopy and FIT

explanations, preparations for tests, and

3) Low numbers of ordering CRC

screenings on those who are eligible

4) Lack of follow-up for outstanding FIT

that were ordered

5) Lack of patient education information

regarding CRC screening options

frequency of tests placed in patient rooms.

6) Inadequate documentation of patient

refusals of CRC screening tests

Utilization of comments box in EHR within

screening window of colonoscopy and FIT

CRC = colorectal cancer; EHR = electronic health record; FIT = fecal immunochemical test; NP = nurse practitioner.

Data were compiled and provided to all NPs after weekly chart audits; NPs were

given the number of patients eligible for CRC

screening along with the actual number of screenings ordered. Data were also orga-

nized by NP name and posted on the clinic

QI board weekly. Specific feedback was also given through individual flags in the EHR,

which were sent to NPs requesting clarifica-

tion of documentation. Two weeks postimplementation, FIT

follow-up letters were sent to all patients with

uncompleted FITs. Letters were written in

English and Spanish, and included in the EHR

for tracking purposes. Monthly follow-up letters

continued to be mailed to all patients with

uncompleted FITs.

GOAL 4: EVALUATE THE PROGRESS OF THE INTERVENTIONS IMPLEMENTED

A retrospective review of 200 new charts

began in March 2016. To ensure consistency in pre and postintervention data analysis of

Reprinted

with permission.

these two patient groups, identical data points

were collected in the postintervention chart review (Table 4).

Postintervention results showed 150 charts of 200 (75%) had CRC screenings

ordered by the NP or were up to date. We

compared the proportions of CRC screening

for the two independent samples by calcu- lating z scores to test our hypothesis. The

Z statistic was determined to be 27.4635 (p

value <.0001), which correlates with sig-

nificant improvement from pre to postdata equating to a 74% increase in screenings

ordered, and a 56% increase in screenings

completed (Figure 2).

Of the 200 charts, 116 (58%) had CRC

screenings ordered and completed or were up to date. By almost doubling this measure,

the NMCH is closer to their goal of 70%. The z statistic was determined to be 25.64

(p value <.0001), which also correlates with significant improvement from pre to postdata

(Table 5). Postintervention also revealed

that 12 (24%) charts had a patient refusal

documented compared with 4% in predata

Generating and Assessing Evidence for Nursing Practice (11th ed.)

426 APPENDIX M #® Increasing Colorectal Cancer Screening Using a Ol Approach

Table 4 Sample Characteristics of Pre and Postintervention Data eT

Preintervention Postintervention

Characteristic (02/2015), n = 200 (01/2016), n = 200

Age group, n (%) 51-59 120 (60) 116 (58)

60-69 75 (38) SiS)

70-75 5 (2) 11 (5) Sex, n (%)

Female 116 (58) 137 (68)

Male 84 (42) 63 (32)

Race/ethnicity, n (%)

Caucasian 176 (88) 192 (96)

Hispanic 20 (10) 7 (4)

Other 4 (2) 1 (1)

Health insurance coverage type, n (%)

Medicaid 59 (29.5) 86 (43)

Self-pay 53 (26.5) 27 (14) Medicare 45 (22.5) 55 (28)

Private insurance 43 (21.5) 32 (16)

80%

70%

60%

£ 50% « ee 40% {= % 30%

5 20%

10%

0% a)

[ a Pre-intervention iy

@ Post-intervention |

Figure 2. Pre and post intervention comparison of colorectal cancer screening ordered and completed at nurse-managed health clinic (2015).

results. Seventy-eight letters were mailed one were seen at the NMHC. Because of this time to patients who had not completed their increase, provider feedback was decreased FIT. The mean rate of return was 42% for to biweekly and included overall screen- the FITs. ing rates and NP documentation of patient

One month postimplementation, increases refusals. Overall screening rates continued in the overall numbers for CRC screening to be posted biweekly by provider on the QI

APPENDIX M Increasing Colorectal Cancer Screening Using a Ol Approach 427

Table 5 Pre and Postintervention Comparison of Colorectal Cancer Screenings for Those Patients Who Were Up to Date or Had Screenings Ordered and Those Patients Where Screening Was Completed iii

Predata

(n = 200),

n (%)

Colorectal cancer screening 76 (38)

up to date or ordered

Colorectal cancer screening 60 (30)

completed

bulletin board and were reported monthly at the QI meeting.

Because interventions were implemented, the impact on the overall screening comple-

tions has been positive. Since October 2015, 19 patients have had either a positive FIT

or colonoscopies. Of these, 11 patients had polyps removed, thus preventing the potential growth of these polyps into CRC.

Confounding factors could have also contributed to this increase in ordering and

completion of screening. In 2015, the clinic hired a QI Coordinator to drive QI initiatives

and also an additional patient navigator to patient enrollment for insurance through the Affordable Care Act.

GOAL 5: SUSTAIN PROCESS CHANGES

Monthly feedback was given to individual

providers and continues to be posted at the NMHC. Pre and postintervention data were

presented to the QI committee, where ideas were discussed for ongoing sustainability. First, the committee wanted to educate the

staff on project outcomes to encourage staff

to help with sustainability. Next, it was deter- mined to continue to post the monthly data

on the number of CRC screenings ordered by provider at the NMHC. The QI commit-

tee also determined the positive value of the FIT follow-up letter and will continue this

intervention.

Reprinted

with permission.

Postdata

(n = 200), % Change

n (%) (increase) Zstatistic pvalue

150 (75) 74 —7.4635 <.001

116 (58) 56 —5.64 <.001

# Limitations

There are several limitations to this project.

The Affordable Care Act was changing the

payer system structure in the United States,

especially for the underserved population,

during the project implementation. Those patients who had suboptimal or no health insurance were now able to afford preventive

screenings. This influx of patients with health insurance could have influenced the results. This project was completed at one NMHC

in a rural, underserved setting and, therefore,

generalizability of the results may vary across

geographic areas.

—# Discussion

The six goals outlined in this project were

achieved and assisted in the improvement of

CRC screening rates in this NMHC. Based on the positive results, the QJ interventions

that were developed and implemented had a significant impact not only on the numbers of CRC screenings ordered on patients but also on the numbers of patients who completed

their CRC screenings. Four main themes emerged that influenced

the increase in the CRC screening rates. The

first theme, using multiple interventions, sum-

marizes the implementation of this QI project.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

428 APPENDIX MM

Healthcare QI processes are multidimensional

and complex. Assessing these processes brings

about identification of multiple problems that require various interventions to posi-

tively bring about change. In this project, six

different QI interventions were implemented

concurrently to target the six problems

identified. This multifaceted approach to increase screening rates was also previously

noted in the literature. Using an approach

with multiple interventions helped to improve

CRC screening rates in primary care settings

by 13-23%.1°° The utilization of staff input, theme two,

helped to guide the project development and

will strengthen sustainment. According to

The Deming Institute,” utilization of staff input is crucial to the success of QI initia-

tives. Staff input was used from the inception to the end of this project. The NMHC staff

were presented with the initial data and

asked for their recommendations on how to

improve the findings. Staff had many ideas for improvement and were then motivated to be

a part of the solution. With this initial buy-in,

additional feedback throughout the process

was given freely, with minimal prompting, as providers were excited to see how their ideas

positively affected CRC screening rates. Within this feedback, NPs repeatedly

discussed the difficulty remembering the

numerous preventive screenings they needed to address with patients. Reminder systems,

theme three, were incorporated into workflow

to trigger NPs to order the CRC screenings.

These findings verify that a lack of provider

reminders is a barrier in ordering CRC screen-

ings in the literature.'''° For this project, pop-up reminders in the EHR were initiated

to serve as reminders for the NPs.

Strategic reminders applied to the patients who needed CRC screenings and the provid-

ers. Low-income patients often have compet-

ing health priorities and financial challenges

that contribute to their complicated lives.”4

Within this project, a process was developed

and implemented to provide patients with

reminders to complete their CRC screenings.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Increasing Colorectal Cancer Screening Using a QI Approach

Reminder letters, which were sent to patients through postal mail 2-4 weeks after their visit to those who had not completed their FITs, were effective. Reminder systems, whether

for NPs or for patients, are useful tools to provide and receive quality healthcare.

Theme four, the value of performance

feedback, is an often underused and underes-

timated method for producing positive results in QI. The Deming PDSA model emphasizes

the importance of data-driven continuous improvement that focuses on the needs of

the staff and providing current performance feedback.”° Healthcare personnel want to see

the result of their nursing interventions to grasp whether these strategies were impact-

ful, from both micro and macrosystem

perspectives. After the implementation of the QI interventions, performance feedback was given to the individual NPs on a weekly

basis through emails. These weekly numbers

were also posted on the QI bulletin board for entire NMHC staff to view. This visualization created peer pressure to improve individual

performances, and therefore, have an impact on the organization’s overall goal.

=# Conclusion

Colorectal cancer is one of the most com- mon cancers with high patient morbidity

and mortality; the disease also provides a significant financial burden to the patient and healthcare system. However, positive outcomes can result for patients afflicted with CRC through the early detection and diagnosis through screening methods (i.e., colonoscopy and FIT). Through the Deming

PDSA QI model, an assessment was com-

pleted and multiple interventions were developed and implemented that successfully

increased CRC screening rates at a NMHC.

These interventions incorporated the QI principles of using multiple interventions, using staff input to develop and sustain last- ing change, implementing staff and patient

Reprinted

with permission.

oe APPENDIXM &

reminders, and using data-driven information to provide performance feedback to staff. This project demonstrates that applying QI principles to the challenge of increasing CRC screening rates at a NMHC can result in

positive patient and healthcare organization outcomes.

# Implications for Practice

Using these QI interventions has had a substan-

tial impact on the quality of care for patients in this NMHC at minimal organizational cost.

This project used existing EHR technology

to provide patient and staff reminders and to

establish an easier workflow for ordering and following up of the FIT. In addition, a minimal time commitment was necessary to provide

valuable performance feedback, which will be sustained through the QI committee.

The economic impact on the patients was

also significant. The overall increase in the

number of patients screened for CRC will

ultimately lead to a decreased need for CRC

treatment. Through CRC screening, polyps

are discovered and removed at an earlier

stage. Because these polyps were identified early, they are less likely to progress into

more complicated CRC treatment regimens,

thus decreasing the burden of cost to patients and third party payers.

Primary care providers and leaders in

healthcare may find this project’s design

and findings useful and easily transferred to primary care organizations. The overall

impact of this project resulted in the preven-

tion of CRC.in 11 patients; thus, decreasing

the morbidity and mortality of this under- served patient population. These QI inter-

ventions could also be applied to additional preventive screening practices in primary

care clinics. Adoption of reminders for NPs

or patients could be easily transferred to

screenings such as mammograms for the detection of breast cancer or cervical cancer

screenings.

Reprinted

with permission.

Increasing Colorectal Cancer Screening Using a Ol Approach 429

REFERENCES 1. Meester RG, Doubeni CA, Lansdorp-Vogelaar I,

et al. Colorectal cancer deaths attributable to nonuse of screening in the United States. Ann Epidemiol. 2015;25:208-213.

2. Survival rates for colorectal cancer screening. American Cancer Society Website. http://www. cancer.org/cancer/colonandrectumcancer/

detailedguide/colorectal-cancer-survival-rates. Updated January 20, 2016. Accessed June 22, 2016.

3. Smith RA, Manassaram-Baptiste D, Brooks D, et al. Cancer screening in the United States, 2015: A review of current American Cancer Society guidelines and current issues in cancer screening. Cancer. 2015;65:30-54.

4. United States Preventive Services Task Force

(USPSTF). Screening for colorectal cancer:

U.S. Preventive Services Task Force recommen-

dation statement. Ann Intern Med. 2008;149: 627-637.

5. Healthy people 2020 topics and objectives. Healthy People 2020 Website. http://www.healthy- people.gov/2020/leading-health-indicators/2020- lhi-topics/Clinical-Preventive-Services/data#c16. Accessed October 5, 2015.

6. Daly J. Fecal immunochemical tests for colorectal cancer screening. Am J Nurs. 2012;112:67-69.

7. Centers for Disease Control and Prevention

(CDC). Vital signs: Colorectal cancer screening test use—United States. MMWR Morb Mortal Wkly Rep. 2013;62:881-888.

8. Policy brief: Nurse-managed health clinics:

Increasing access to primary care and educating the healthcare workforce. American Association of Colleges of Nursing Website. http://www.aacn. nche.edu/government-affairs/FY 13 NMHCs.pdf. Published 2013. Accessed December 16, 2015.

9. Hansen-Turton T, Bailey DN, Torres N, Ritter A.

Nurse-managed health centers: Key to a healthy

future. Am J Nurs. 2010;110:23-26. 10. Daly JM, Levy BT, Moss CA, Bay CP. System

strategies for colorectal cancer screening at feder- ally qualified health centers. Am J Public Health.

2015;105(1):212-219. 11. Garcia-Dominic O, Lengerich EJ, Wray LA,

et al. Barriers to colorectal cancer screening among latino adults in Pennsylvania: ACCN results. Am J Health Behav. 2012;36(2):153-167.

12. Quick B, Hester C, Young K, Greiner K. Self- reported barriers to colorectal cancer screening

in a racially diverse, low-income study popula- tion. ] Community Health. 2013;38(2):

285-292. 13. Guessous I, Dash C, Lapin P, Doroshenk M,

Smith RA, Klabunde CN. Colorectal cancer

screening barriers and facilitators in older persons.

Prev Med. 2010;50(1-2):3-10.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

430 APPENDIXM #® Increasing Colorectal Cancer Screening Using a Ol Approach

14. Davis TC, Arnold CL, Rademaker AW, et al. FOBT

completion in FQHCs: Impact of physician recom-

mendation, FOBT information, or receipt of the

FOBT Kit. J Rural Health. 2012;28(3):306-311.

AUTHORS’ BIOGRAPHIES

Diane Hountz, DNP, MS, ANP, RN is a Clinical 15. Lopez-Class M, Luta G, Noone AM, et al. Patient Assistant Professor, School of Nursing, Purdue

and provider factors associated with colorectal University, West Lafayette, IN. She holds a cancer screening in safety net clinics serving low- Soe Boy Certification and currently teaches income, urban immigrant Latinos. J Health Care iia Poor Underserved. 2012:23(3):1011-1019: quality improvement to undergraduate nurs-

16. Menon U, Belue R, Wahab S, et al. A randomized ing students. She has acted as the Quality trial comparing the effect of two phone-based Improvement Coordinator for the North Central

interventions on colorectal cancer screening adher- Nursing Clinics. ence. Ann Behav Med. 2011;42(3):294-303. Jennifer Coddington, DNP, MSN, RN, CPNP

17. Lairson DR, Dicarlo M, Deshmuk AA, et al. is a Clinical Associate Professor, School of Cost-effectiveness of a standard intervention Nursing, Purdue University, West Lafayette, versus a navigated intervention on colorectal IN. She is also the Director of the Primary

SOL Joe odo=to4omment ee Care Pediatric Nurse Practitioner Master’s

18. McFall AM, Ryan JE, Hager P. Implementing a Program, Director of Practice and Outreach

client reminder intervention for colorectal cancer and the Medical Director of North Central screening at a health insurance worksite. Prev Nursing Clinics. Chronic Dis. 2014;11:E20. Karen J. Foli, PhD, RN is an Associate Professor,

19. Lasser KE, Murillo J, Lisboa S, et al. Colorectal School of Nursing, Purdue University, West

cancer screening among ethnically diverse, low- Lafayette, IN. She is also the director of the income aE, randomized controlled trial. PhD program in Nursing at Purdue and holds Arch Intern Med. 2011;171(10):906-912. : Lae .

20. Hendren S, Winters P, Humiston S. Randomized, velo, EECA IE TSEC OLESEN : : : ; Sigma.

controlled trial of a multimodal intervention ’ pa. J to improve cancer screening rates in a safety- Janet Thorlton, PhD, RN is a Clinical Associate

net primary care practice. J Gen Intern Med. Professor, School of Nursing, Purdue University, 2014;29(1):41-49. West Lafayette, IN. She is also a member of the

21. Elmulti D, Kathawala Y. A preliminary analy- Center for Health Outcomes & Policy Safety Net

sis of Deming’s quality improvement program: Research team at the Purdue Regenstrief Center

Some insights. Prod Inventory Manage J. for Healthcare Engineering. Across the curric- 199451994(35):52-S6. ' ; ulum, she teaches Evidence Based Practice and

22. Science of improvement: How to improve. Institute Teor:

for Healthcare Improvement (IHI) Website. http:// Z www.ihi.org/resources/Pages/HowtoImprove/

Science of ImprovementHowtolmprove.aspx. . : : ; Neseeed Match 2100168 For more information on this article,

23. The PDSA cycle. The Deming Institute Website. contact Jennifer Coddington at jsundell@ https://www.deming.org/theman/theories/pdsacy- purdue.edu.

cle. Accessed April 13, 2016. The authors declare no conflicts of interest. 24. Khankari K, Eder M, Osborn C, et al. Improving

colorectal cancer screening among the medically underserved: A Pilot study within a federally quali- fied health center. J Gen Intern Med. 2007;22(10):

410-1414.

25. Clark D, Silvester K, Knowles S. Lean management

systems: Creating a culture of continuous quality

improvement. J Clin Pathol. 2013;66:638-643.

APPENDIX N-

HEALTH CARE PRACTITIONER Pain COMMUNICATION: R21 GRANT APPLICATION Deborah Dillon McDonald

432 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Form Approved Through 09/30/2007 OMB No. 0925-0001

LEAVE BLANK—FOR PHS USE ONLY. Department of Health and Human Services Public Health Services

Grant Application Do not exceed character length restrictions indicated.

TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)

Older Adults’ Response to Health Care Practitioner Pain Communication 2. RESPONSE TO SPECIFIC REQUEST FOR APPLICATIONS OR PROGRAM ANNOUNCEMENT OR SOLICITATION LJ no &] Yes

(If “Yes,” state number and title)

Number: PA-03-152 Title: Biobehavioral Pain Research

3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR New Investigator [_]No [X] Yes

3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. eRA Commons User Name

McDonald, Deborah Dillon BS MS PhD

3c. POSITION TITLE 3d. MAILING ADDRESS (Street, city, state, zip code)

Associate Professor : The University of Connecticut 3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT School of Nursing

OF ESEHOMNES 231 Glenbrook Road, Unit 2026 3f. MAJOR SUBDIVISION Storrs, CT 06269-2026

N/A

3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS:

Formerly Review Group

Date Received Council/Board (Month, Year)

iff

[TEL: 860-486-3714 FAX: 860-486-0001 [email protected]

4. HUMAN SUBJECTS ||4. Human Subjects Assurance No. SO Conse eee eens

RESEARCH FWA00007125 4c. Clinical Trial 4d. NIH-defined Phase III 5a. If “Yes,” IACUC approval 5b. Animal welfare assurance no.

LJ No & Yes No L] Yes Clinical Trial KX] No LJ] Yes Bale =a

AL IRESCANAN CY If “Yes,” Exemption No. A3124-01 XX No (] Yes 6. DATES OF PROPOSED PERIOD OF

SUPPORT (month, day, year—MM/DD/YY)

From Through

7. COSTS REQUESTED FOR INITIAL BUDGET PERIOD

7a. Direct Costs ($) 7b. Total Costs ($)

8. COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT

8a. Direct Costs ($) 8b. Total Costs ($)

5/01/06 4/30/08 $100,000 eee $148,000 $175,000 $259,000 |

9. APPLICANT ORGANIZATION 10. TYPE OF ORGANIZATION

Name —_ University of Connecticut Public: 1! [] Federal [&X state [] Local

Address Office for Sponsored Programs Private: 1 [_] Private Nonprofit 438 Whitney Road Ext., Unit 1133 For-profit:! [_] General [_] Small Business

Storrs, CT 06269-1133 LJ Woman-owned [] Socially and Economically Disadvantaged

Telephone: 860-486-3622 11. ENTITY IDENTIFICATION NUMBER

Fax: 860-486-3726; Email: [email protected] 06-0772160 DUNS NO. 614209054 Cong. District Second

12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE 13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION Name Carol Welt, PhD Name Carol Welt, PhD

Title Executive Director & Assist. V. Prov. Research Title Executive Director & Assist. V. Prov. Research

Address Office of Sponsored Programs

438 Whitney Road Ext., Unit 1133

Storrs, CT 06269-1133

Tel: 860-486-8704 FAX: 860-486-3726

E-Mail: — [email protected] 14. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR ASSURANCE: | certify that the statements herein are true, complete and accurate to the best of my knowledge. | am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. | agree to accept responsibility for the scientific

conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application.

15. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: | certify that the statements herein are true, complete and accurate to the best of my knowledge, and accept the obligation to comply with Public Health Services terms and conditions if a grant is awarded as a result of this application. | am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties.

PHS 398 (Rev. 09/04) Face Page

Address Office of Sponsored Programs 438 Whitney Road Ext., Unit 1133

Storrs, CT 06269-1133

Tel: 860-486-8704 FAX: 860-486-3726

E-Mail: [email protected] SIGNATURE OF PI/PD NAMED IN 3a. DATE (In ink. “Per” signature not acceptable.)

SIGNATURE OF OFFICIAL NAMED IN 13. DATE (In ink. “Per” signature not acceptable.)

Form Page 1

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 433

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

DESCRIPTION: See instructions. State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe concisely the research design and methods for achieving these goals. Describe the rationale and techniques you will use to pursue these goals.

In addition, in two or three sentences, describe in plain, lay language the relevance of this research to public health. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED.

How practitioners communicate with patients about their pain has been overlooked as a factor contributing to

effective pain management. Eliciting important pain information from patients enables practitioners to

prescribe more specific pain treatments, and significantly decrease pain. The aim of our study is to test the

effect of practitioners asking patients an open-ended question about pain that does not encourage a socially

desirable response. A posttest only double blind experiment will test how the phrasing of health care

practitioners’ pain questions, open-ended and without social desirability bias; closed-ended and without

social desirability bias; or open-ended and with social desirability bias, affects the pain information provided

by people with chronic pain. Three hundred community dwelling older adults with chronic osteoarthritis pain

will be randomly assigned to one of the three practitioner pain communication conditions. Older adults will

watch and verbally respond to a videotape clip of a practitioner asking the patient about their pain. The clips

will be identical except for the pain question asked by the practitioner. After responding to the pain question,

all of the older adults will respond to a second videotape clip of the practitioner asking if there is anything

further they want to communicate. The older adults will then respond to a third videotape clip asking if there

is anything further they want to communicate about their pain. Responses to the three videotape clips will be

audiotaped. To control for pain differences between participants, the Brief Pain Inventory Short Form will be

administered to measure present pain intensity and pain interference with functional activities. Participants’

audiotaped responses will be transcribed and content analyzed using a priori criteria from national guidelines

to identify communicated pain information and omitted pain information important for osteoarthritis pain

management. The three groups will be compared for the communicated pain information and omitted pain

information while controlling for present pain intensity and pain interference with activities. The goal is to

identify practitioner pain communication strategies that allow patients to describe pain information important

for guiding effective pain management, and to substantiate what pain information is missed when

practitioners use less effective pain communication. The results will provide empirically tested

communication strategies that can be used in practitioner and patient pain communication.

PERFORMANCE SITE(S) (organization, city, state)

University of Connecticut School of Nursing, Storrs, CT

P.C. Smith Towers, Hartford, CT

Betty Knox Apartments, Hartford, CT

Capitol Towers, Hartford, CT

Fireside Apartments, Bridgeport, CT

Harborview Towers, Bridgeport, CT

Park Ridge | and Il, New Haven, CT

Tower One/Tower East, New Haven, CT

PHS 398 (Rev. 09/04) Page 2 Form Page 2

Generating and Assessing Evidence for Nursing Practice (11th ed.) with permission.

434 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below.

Start with Principal Investigator. List all other key personnel in alphabetical order, last name first.

Name eRA Commons User Name Organization Role on Project

McDonald Deborah Dillon University of Connecticut PI

Katz, Leonard University of Connecticut Statistical Consultant

Rosiene, Joel Eastern CT State Univ. Computer Consultant

Maura Shea University of Connecticut Graduate Assistant

Leonie Rose University of Connecticut Graduate Assistant

OTHER SIGNIFICANT CONTRIBUTORS

Name Organization Role on Project

N/A

Human Embryonic Stem Cells XX] No L Yes

If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list:

http://stemcells.nih.gov/registry/index.asp. Use continuation pages as needed,

If a specific line cannot be referenced at this time, include a statement that one from the Registry will be used.

Cell Line

Disclosure Permission Statement. Applicable to SBIR/STTR Only. See SBIR/STTR instructions. I Yes ol No

PHS 398 (Rev. 09/04) Page 3 Form Page 2-continued Number the following pages consecutively throughout

the application. Do not use suffixes such as 4a, 4b.

APPENDIXN Health Care Practitioner Pain Communication: R21 Grant Application 435

Principal Investigator/Program Director (Last, First, Middle). McDonald, Deborah Dillon

The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page.

RESEARCH GRANT

TABLE OF CONTENTS

Page Numbers

Face Page 1

Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human

EEMDKYOMIC SCONMG OLS trrecarcressasasececcescecnctsececsuserscestuccrepevenvectetoens otter cessens nettetettttete cseorioone cused 2-3

UE TALS ey Oe EY Se ecco ce or eR nn nn oe Re eo ee 4

Detailed Budget for Initial Budget Period (or Modular BUdge?)...........cccccccsesesessssssssscessersssescsesesereeteeeeee S

Budget for Entire Proposed Period of Support (not applicable with Modular Budget)...........c:sssesseessesee- N/A

Budgets Pertaining to Consortium/Contractual Arrangements (not applicable with Modular Budget) N/A

Biographical Sketch — Principal Investigator/Program Director (Not to exceed four PpageS) ..............002.- 6-7

Other Biographical Sketches (Not to exceed four pages for each — See iNstrUuctiONS) .......cccccccececeeeeeeee 8-12

RESOUNGCES (rrr tir ais xs Mctss teoeee astate cashes acer socceddesstrasvdesstastuateaes fincas bincct ses sei cecsuenares sesticainasn oducts cheese nevistisevicwetvansanes 13

Rese@arc hii Planitencrcercsscocntssectrcscrscacsstes care sevialescraee sasrersustsvert ceccsscurtvetiasvatsécusa torsvenscerescassoudeuctecatonecerasteceteeeee 14-28

Introduction toiRevisedApplication: (Not toiexceed!3\ pages) mana. nosvtecsencsescotasscsdvatscvevsarsssteseasesssdevaceboses bist fostervadeelinstiesteestb oles J N/A

Introduction to Supplemental Application (Not to ExCe@D ONE PAGE) ......cseecessecseesessseneetststsvecsesvecseseevecseacscsesescsesessseaescatscseasscesatsceeseee N/A

INSES PEGING AIMS n2-3d Berets a ie teria. eeeg eared Wane d4)

B. Background and Significance __ 15-18 C. Preliminary Studies/Progress Report/ (Items A-D: not to exceed 25 pages*) 18-19

Phase | Progress Report (SBIR/STTR Phase I! ONLY) * SBIR/STTR Phase |: Items A-D limited to 15 pages.

Dam researchibesignranciviothodsmmscstisc crete ttt tect eee ee cen aoev cestecriesteretrementeennrane ete errr ee caierreseeacet 19-28

Es ihuman Subjectsiesearchvem en steeeemetyae cee s reece ta cate a eee ed. Croniied Stat Peentenvnea coche teree et semetey Saas __ 29-34

Protection of Human Subjects (Required if Item 4 on the Face Page is marked “YES”)......ccccscccsesesessesesseceseseevseseevsesteneee 29-32

Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked “Yes” and a Phase |, Il,

OmlliclinicaljtriallispropOSGd) yeepta cee reverse seco ct Meee rates urea cate eee vac Sane See cs aCe ree es RT ea eat) N/A

Inclusion of Women and Minorities (Required if Item 4 on the Face Page is marked “Yes” and is Clinical Research) .... ey,

Targeted/Planned Enrollment Table (for new and continuing clinical research Studies) ..........ccccceeseeeeeserseseesterteesees 33

Inclusion of Children (Required if Item 4 on the Face Page is marked “Yes’) .... 34

F. Vertebrate Animals 34

G. Literature Cited 34-37

H. Consortium/Contractual Arrangements.... N/A

|. Resource Sharing N/A

J. Letters of Support (e.g., Consultants) 38-45

Commercialization Plan (SBIR/STTR Phase II and Fast-Track ONLY) .... N/A

GHECKIIS tapeeresnreee seers ace tere ieee eee Seer carats a pete se conecrevctomsiric cractesavtvceaesthertecencersrcctensMeereemecrtovascestrreseas 46

Appendix (Five collated sets. No page numbering necessary for Appendix.) Check if ‘ ¢ Appendix is

Appendices NOT PERMITTED for Phase | SBIR/STTR unless specifically SOlCItEG. «2.2.2.2... cccesecece cece tees eeeseseeeseseeretseeterscatenes XI Included

Number of publications and manuscripts accepted for publication (not to exceed 10) 5

Other items (list):

Brief Pain Inventory Short Form

Demographic Form

PHS 398 (Rev. 09/04) Page 4 Form Page 3

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

436 APPENDIXN #® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

BUDGET JUSTIFICATION PAGE MODULAR RESEARCH GRANT APPLICATION

Sum Total (For Entire Project

Period) Initial Period 3d 4" a

DC less Consortium F&A 100,000

(Item 7a, Face Page)

Consortium F&A

Total Direct Costs 100,000

Personnel

Deborah Dillon McDonald, RN, PhD, Principal Investigator (Y1-20% & 50% summer; Y2-20% & 50%

summer) will be responsible for the overall administration and completion of the project. She will collaborate

with the videotape production company to produce the health care practitioner videotape clips. She will

consult with Dr. Rosiene to program the laptop computer with touch screen. She will train and supervise the

GA. She will prepare the sites for data collection and maintain contact with sites throughout the study. She

will conduct the content analysis with the GA, statistically analyze the data in consultation with Dr. Katz,

write, and submit manuscripts reporting the findings.

175,000

(Item 8a, Face Page)

75,000

Leonard Katz, PhD, Consultant (Y2-1% effort) will advise the PI regarding statistical analyses.

Joel Rosiene, PhD, Consultant (Y1-5% effort) will program the laptop computer with the SuperLab 3.0

software and insert the health care practitioner videotape clips as the experimental manipulation. He will test

the program and resolve any programming issues. He will remain available for consultation in the event of

future programming problems.

TBA, Graduate Assistant (Y1-8 mos., 20 hrs/wk; Y2-4 mos., 20 hrs/wk; Y2-4 mos., 10 hrs/wk) will recruit

eligible older adults, provide informed consent, data collect, debrief, and compensate the older adults. The

GA will also transcribe the audiotaped responses. The GA will content analyze the data with the PI, enter the

data into a SPSS data base, and clean the data to remove input errors.

Explanation for Budget Deviation

The increased budget by $25,000 during year one is due to the cost of video development and the need for

the 20 hour per week GA during eight months.

Consortium

N/A

Fee (SBIR/STTR Only)

N/A

PHS 398 (Rev. 09/04) Page 5 Modular Budget Format Page

APPENDIXN ™ — Health Care Practitioner Pain Communication: R21 Grant Application 437

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2.

Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME

Deborah Dillon McDonald

eRA COMMONS USER NAME

POSITION TITLE

Associate Professor

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)

INSTITUTION AND LOCATION Peas YEAR(s) | _FIELD OF STUDY

Marycrest College, Davenport, IA BSN 1975 Nursing University of Connecticut, Storrs, CT MS 1981 Nursing Columbia University, New York, NY PhD 1990 Social Psychology

A. Positions and Honors

1975-1978 Navy Regional Medical Center, Long Beach, CA; Lieutenant in Nurse Corps

1978-1979 Hartford Hospital, Hartford, CT; Staff

1981-1983 Elms College, Chicopee, MA; Assistant Professor of Nursing

1983-1986 University of Connecticut, Storrs, CT; Assistant Professor of Nursing

1988-1990 National Center for Nursing Research Pre-doctoral Fellowship

at Columbia University, New York, NY; Pre-doctoral Fellow

1990-present University of Connecticut, Storrs, CT; Associate Professor

B. Selected Peer-Reviewed Publications

McDonald, D. (1993). Postoperative narcotic analgesic administration: A pilot study. Applied Nursing

Research. 6, 106-110.

McDonald, D. (1994). Gender and ethnic stereotyping and narcotic analgesic administration.

Research in Nursing & Health, 17, 45-49. McDonald, D. (1996). Nurses' memory of patient's pain. /nternational Journal of Nursing Studies. 23,

487-494. McDonald, D., & Sterling, R. (1998). Acute pain reduction strategies used by well older adults.

International Journal of Nursing Studies, 35, 265-70.

Wessman, A., & McDonald, D. (1999). Nurses’ personal pain experiences and their pain management knowledge. Journal of Continuing Education in Nursing, 30, 152-157.

McDonald, D. (1999). Postoperative pain after hospital discharge. Clinical Nursing Research, 8, 347-

359: McDonald, D., McNulty, J., Erickson, K., & Weiskopf, C. (2000). Communicating pain and pain

management needs after surgery. Applied Nursing Research, 13, 70-75. McDonald, D., Freeland, M., Thomas, G., & Moore, J. (2001). Testing a preoperative pain

management intervention for elders. Research in Nursing & Health, 24, 402-409. McDonald, D. & Weiskopf, C. (2001). Adult patients’ postoperative pain descriptions and responses to

the Short-Form McGill Pain Questionnaire. Clinical Nursing Research, 10, 442-452.

Tafas, C., Patiraki, E., McDonald, D. & Lemonidou, C. (2002). Testing an instrument measuring Greek nurses’ knowledge and attitudes regarding pain. Cancer Nursing, 25 (1), 1 — 7.

PHS 398/2590 (Rev, 09/04) Page 6 _ Biographical Sketch Format Page

438 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

McDonald, D., Pourier, S., Gonzalez, T., Brace, J., Lakhani, K., Landry, S. & Wrigley, P. (2002). Pain

problems in young adults and pain reduction strategies. Pain Management Nursing, 3(3), 81-

86. McDonald, D. & Molony, S. (2004). Postoperative pain communication skills for older adults. Western

Journal of Nursing Research, 26, 836 — 852, 858 - 859.

Patiraki - Kourbani , E., Tafas , C., McDonald , D., Papathanassoglou , E., Katsaragakis , S. &

Lemonidou , C. (2004). Greek nurses’ personal and professional pain experiences.

International Journal of Nursing Studies, 41, 345-54. McDonald, D., Thomas, G., Livingston, K. & Severson, J. (2005). Assisting older adults to

communicate their postoperative pain. Clinical Nursing Research, 14, 109-126. McDonald, D., LaPorta, M., & Meadows-Oliver, M. (2006). Nurses’ response to pain communication

from patients: A post-test experimental Study. International Journal of Nursing Studies.

C. Research Support

National Institute of Nursing Research, 1R21NR009848-01, 3/16/06 — 3/15/08, McDonald PI Older Adults’ Response to Health Care Practitioner Pain Communication The aim of our study is to test the effect of practitioners asking patients an open-ended question about

pain that does not encourage a socially desirable response.

Donaghue Foundation, 10/1/01 — 10/1/02; McDonald PI

Assisting Elders to Communicate their Pain After Surgery

The goal of the study was to refine our videotape intervention teaching older adults about

postoperative pain communication and pain management, and test the effects of the videotape

intervention on the pain outcomes of older adults after major surgery.

National Institute of Nursing Research, 1 R15 NRO4876-03, 5/1/99 — 10/1/01; McDonald PI

Postoperative Pain Communication Skills for Older Adults

The goal of the study was to develop a videotape intervention teaching older adults about

postoperative pain communication and pain management, and test the effects of the videotape

intervention on the pain outcomes of older adults after major surgery.

University of Athens, Athens, Greece, 11/98 — 1/03; McDonald Co-Investigator Nurses’ Knowledge Regarding Pain and Cancer Patients’ Reports of Pain Control The goal of the study was to test the construct validity, test-retest reliability, and internal consistency

of the Greek version of the Nurses’ Knowledge and Attitudes Survey Regarding Pain (NKASRP) with

Greek nurses, as phase | in a series of studies examining how to improve pain outcomes for cancer patients in Greece.

PHS 398/2590 (Rev. 09/04) Page 7 Continuation Format Page

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 439

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

Resources

Clinical: We will recruit and conduct the study at seven independent living elder housing sites throughout Connecticut. The urban sites in Bridgeport, New Haven and, Hartford, CT increase the opportunity to include Black or African Americans, Hispanic and Asian elders. The sites include P.C. Smith Towers, Capitol Towers, and the Betty Knox Apartments in Hartford, CT; Park Ridge | and II

and Tower One/Tower East in New Haven, CT; and Fireside Apartments and Harborview Towers in

Bridgeport, CT. The sites contain from 193 to 248 housing units each, insuring a large group of older adults for our study.

Computer: The PI has a Dell Pentium 4 computer 2.4 GHz with 256 MB RAM, loaded with SPSS- 13.0 and Word 2000 professional operating system; and a Hewlett Packard LaserJet5 printer in her university office. Additional computer resources are available through the Center for Nursing Research (CNR) in the School of Nursing at the University of Connecticut. Fourteen new Dell computers each with Intel Pentium 4 processor 520’s are available. There are two HP LaserJet IV printers, one HP LaserJet III printer, one HP LaserJet 1200, one HP LaserJet 5L printer, one Laser Jet 1100 printer, and an HP Office jet 5110 all-in-one copier, scanner, and printer. All computers

have direct access to the university mainframe computer, the university library system, and the

Internet. Software programs available on the PCs in the CNR relevant for our study include: Power and Precision, QRS N6 (NUD*IST), and SPSS 12.0.

Office: The PI has a private university office, telephone, and four locked filing cabinets. Various

support personnel are available through the Center for Nursing Research at the School of Nursing. Work-study students, graduate assistants, and secretaries are available for assisting with all aspects of a research project. In addition, a program for doctoral study in the School of Nursing offers a pool of well-qualified graduate nursing students from which to select a research assistant for the study.

Other: The Seven Seas Film Company located in Madison, CT will produce the three videotape clips

of the health care practitioner asking the older adults about their pain, the two follow up videotape clips, and the test videotape that will be used to adjust the audibility of the videotapes for each

participant. Seven Seas produced our 15-minute documentary style pain communication videotape tested with older adults and reported in McDonald, et al., (2005). Seven Seas has produced films for

the Public Broadcasting Service (PBS) and major universities.

MAJOR EQUIPMENT: List the most important equipment items already available for this project, noting the location and pertinent capabilities of each.

The University of Connecticut School of Nursing offers access to additional equipment. There are multiple copiers (i.e. Cannon IR3300, Savin 4060 SP, all with sorter and stapler, a color scanner (HP

Office jet 9130), a color printer (Hewlett Packard color laser jet 5550hdn) and two independent fax lines. In addition to readily available equipment, there is ample conference meeting space and

facilities for use in research projects.

PHS 398/2590 (Rev. 09/04) Page 13 tial

Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

440 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

A. Specific Aims

Management of patients’ pain is one of the most enduring challenges facing all health care

practitioners. Assessment of pain is now an assumed standard of practice required by the Joint Commission for Accreditation of Health Care Organizations. Pain communication between patients

and practitioners provides a critical link for the assessment and management of pain.

Inadequate pain communication belween patients and health care practitioners" 3 can result in

sustained or increased pain for patients.* Researchers have shown that pain remained undiagnosed

for 53% of patients with moderate pain and 30% with severe pain during their primary care outpatient

visit,° indicating that pain was not addressed despite a pressing need to talk about pain. Nearly half of the people reported moderate levels of acute® or chronic pain’ in two recent surveys. Communicating

about pain involves more than use of pain assessment measures. Hospitalized patients did not consider responding to a numerical pain intensity scale equivalent to communicating about pain.” Effective pain communication involves talking with patients in ways that permit patients to more fully discuss salient aspects of their pain experience. Research is needed to test communication strategies

that enhance patient and practitioner communication about pain.

The aim of this study is to test how practitioners’ pain communication affects the pain

information provided by older adults. The study will specifically test the effect of asking an open- ended question about pain that does not direct a socially desirable response. We suspect that a

question about pain presented in what might be perceived as a social exchange (“How are you feeling?”) might not be sufficient to elicit clinically meaningful and important information if patients

perceive a social, rather than a clinical, source of the question. Hypothesis

Older adults asked about their pain with an open-ended question without social desirability bias will describe more important pain information and omit less information than older adults asked

about their pain with a closed-ended question without social desirability or an open-ended question with social desirability bias.

To test the hypothesis, three videos will be developed that portray a health care practitioner

asking participants about their pain in one of three different ways: open-ended without social

desirability, closed-ended without social desirability, and open-ended with social desirability. Older adults with chronic osteoarthritis pain will be randomly assigned to watch and respond to one of the

three videos. The second and third parts of the videos, after the first part of questioning, will be the same. All participants will next watch and respond to the second part of the video with the

practitioner asking if there is anything further participants want to communicate in general, and then the third part with the practitioner asking if there is anything further they want to communicate about

their pain. Participants’ audio taped responses will be content analyzed for important included and omitted pain information.

Older adults with chronic pain due to osteoarthritis will be randomly assigned to one of the three practitioner pain communication conditions. Present pain will be measured with the

counterbalanced Brief Pain Inventory Short Form (BPI-SF) to statistically control for pain differences between participants evident after random assignment while controlling for the timing of the BPI-SF.

Participants’ audio taped responses will be content analyzed using a priori criteria from the American

Pain Society® guidelines for the management of pain in osteoarthritis to identify pain communication content important for osteoarthritis pain management, and important omitted pain information. The three groups will be compared for the included and omitted pain information while controlling for pre- existing, current pain intensity and pain interference with activities. The immediate goal is to identify practitioner pain communication strategies that allow patients to describe important pain information

that can more effectively guide pain management, and significantly reduce or eliminate pain. The

long-term goal is to incorporate empirically tested, theory driven pain communication strategies into health practitioner curricula and patient education.

PHS 398/2590 (Rev. 09/04) Page 14 Continuation Format Page

APPENDIXN Health Care Practitioner Pain Communication: R21 Grant Application 441

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

B. Background and Significance

Communication About Pain Management Effective pain communication involves more than practitioners encouraging patients to identify

when patients have pain. An intervention that encouraged terminally ill patients to talk with their physicians about their pain showed that 43.4% of patients continued to have a pain problem at hospital discharge, and less than half received a pain intervention.° Interventions that only encourage patients to talk about their pain might be inadequate for promoting pain communication. Increased communication between patients and practitioners was not associated with increased pain relief, perhaps because communication was restricted to discussing pain treatments, and asking the patient to alert practitioners when pain occurred. '° Clinical contexts where routine pain communication should be part of standard practice continue to demonstrate deficiencies in pain communication. Physicians discussed pain during only 72% of the outpatient palliative care visits, and initiated the pain topic only half of the time.'' Cancer patients and family caregivers have clearly identified the need for improved communication with their health care practitioners. '* Patients and practitioners need research-based support to help them communicate about pain in ways that lead to greater pain relief for patients.

Reasons for the inadequate pain communication might be directly attributable to the way that practitioners speak with patients. Constructing pain assessment questions in the form of social

conversation (i.e. “How are you today?”) encourages patients to respond in a socially desirable manner by suppressing their pain concerns.*'* These types of approaches might be seen as directing social exchange rather than soliciting important clinical assessment data. Giving little attention to

patients’ reports of pain, and controlling pain communication by interrupting patients, minimizing or

dismissing the reports of pain, and curtailing patient responses to yes/no responses were techniques observed to be used by physicians in a descriptive study of oncology patients consulting with their

physicians. '° Again, these methods to ask for pain information are more directing in soliciting a

response than merely asking a patient, “tell me about your pain.” Physicians challenged and attempted to disconfirm biological explanations for the pain, insisting on psychological explanations when talking with chronic pain patients who had no apparent medical reason for their pain. '* When

subjected to practitioner statements suggesting where the pain might be felt, patients reported significantly more referred pain, and more intense pain.'® The preceding communication techniques

thwart complete and accurate pain discussions between patients and practitioners. Randomized controlled clinical trials are needed to link specific pain communication strategies to patient outcomes.

Patient factors impact pain communication. Patient factors include low expectations for pain

relief,'"” reluctance to bother busy staff,*'*"'® concern about repercussions from staff if patients complain about pain,’ fear of addiction to opioids, '”"®° fear of unpleasant opioid side effects,*'°*" belief that health care providers innately know best how to manage their pain; '’ and general lack of information about pain management, and difficulty articulating pain management needs.“ Hospitalized patients reporting more intense pain communicated about their pain more often, but were less satisfied with the information communicated by the nurse. Older adults communicated less about their pain, but voiced greater satisfaction with the information provided by nurses.” When given the opportunity, many patients clearly describe their pain (e.g. “my leg is going to burst,” “someone

turning a knife under my skin.”“2 Patients have the ability to clearly communicate their pain, but multiple barriers continue to restrain patients from communicating about pain with practitioners.

PHS 398/2590 (Rev. 09/04) Page 15 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

442 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

Pain Communication Interventions Promising interventions to assist patients to describe their pain have been tested, such as

individual coaching prior to an office visit,“* and combinations of written scripts and individual coaching.”* Both interventions resulted in a significant decrease in pain. These findings suggest that

patients can be assisted to effectively communicate their pain and receive interventions that significantly reduce their pain. The cost of the individual coaching interventions might limit the

widespread use of coaching interventions. Both studies involved patients with cancer pain. Individual

coaching interventions for patients with different pain etiologies might not be as effective in eliciting

more responsive pain management from practitioners.

Practitioner Influence in Health Care Communication Health care communication research, conducted mainly in psychology and medicine, provides

insight about pain management communication. The Bayer Institute for Health Care Communication literature review on health care practitioner and patient communication identified only six medical

studies that examined eliciting patients’ agenda.”° All six were limited to descriptive medical studies. Primary care physicians interrupted opening statements by their patients during 77% of the visits, and

patients completed only 1 out of 52 interrupted statements.”° Physician communication remained virtually unchanged 12 years later when physicians again interrupted 72% of the opening

statements.’ Physicians using problem defining communication skills, which included starting off with

an open-ended question to delineate the patient's problem, identified significantly more patients with

emotional distress than physicians not taught problem defining skills. Six months later patient distress remained significantly reduced for patients of physicians using problem defining communication skills.2? Female physicians use more positive statements, more psychosocial information giving, more

active partnership behaviors, but also more closed-ended questions during office visits.2? The ability

to gather or omit potentially important information from patients is influenced by how health care practitioners communicate with patients.

Patient Influence in Health Care Communication

Descriptive and intervention studies have examined patients’ contribution to their health care interaction. During a family practice office visit, younger, more educated, and more anxious patients

who asked more questions received more diagnostic health information. Patients who asked more

questions and expressed more concern received more treatment information from their physicians. °°

Similarly, parents of pediatric patients received more information when they asked more questions and expressed more affect.°' Patients communicated more and provided more biomedical and

psychosocial information, promoted more partnership building, and talked more positively with female physicians.*” Patients trained via a booklet and coaching to talk with their family practice physicians asked more questions about medically related topics, elicited more information from the physician, and provided more information about their medical problems than untrained patients.°? Women either

prompted to think about their questions prior to seeing their women’s health physician or informed that the physician was open to questions were significantly more likely to ask all of the questions that they wanted compared to women in a control group.’ Participants who watched a video with a patient either asking questions or making disclosures communicated more than participants who

watched a video without patient interaction. °° Patients who prior to their office visit were instructed to think about the instructions the physician gave them during the visit, imagine carrying out the

instructions, and to ask the physician questions about problems that they anticipated, communicated significantly more than patients not given any additional instructions, or patients instructed that the physician was open to answering questions.*° Preliminary evaluation of a community based intervention teaching people how to communicate with their physician by teaching them communication skills and helping them practice the skills was associated with a moderate increase in

PHS 398/2590 (Rev. 09/04) Page 16 Continuation Format Page

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

patient confidence for communicating with the physician.°” The variety of successful communication interventions indicates that people can successfully communicate with their health care practitioners when supported to do so.

Linking increased practitioner and patient communication with improved health outcomes substantiates the impact of communication during health care interactions. Patients with diabetes, hypertension, ulcer disease, and breast cancer were tested during three randomized controlled trials and a nonequivalent control trial respectively for the effect of an intervention to improve

communication by patients during health care visits.** The intervention for each study consisted of providing each patient with individualized information about their medical care, and coaching about actively communicating during the visit. The communication techniques included more effective ways to ask questions, keeping focused on the medical care, and negotiating skills. Improved hemoglobin A1c and lowered diastolic blood pressure resulted from more patient control, less physician control, more negative affect expressed by both, more information seeking by patients, and more patient

communication. How patients with chronic health problems communicate with practitioners during their health care visits can directly impact their health outcomes. The success of the individualized coaching intervention demonstrates that patients with different chronic health problems can be assisted to communicate more effectively and impact their health outcomes. The resource intensity of

the intervention remains a drawback.

Pain Communication and Health Practitioner Curricula Practitioner pain management education has been the major means for improving pain

outcomes, but medical and nursing curricula have generally not included education about pain communication beyond pain assessment (e.g. Giamberardino*’), even though experts have identified

pain communication skills as an essential component of training in medical education.*° The benefit of increased education in pain communication was provided by a recent study with pediatric residents.*"

An 18-hour educational intervention teaching physicians a more patient centered approach when communicating about pain problems with patients with fibromyalgia found that patients felt that they

were allowed to fully discuss their pain,** perhaps because of a Hawthorne effect for the physicians,

or low expectations by patients. This resource intensive intervention supported increased pain

communication between patients and practitioners, but the specific communication strategies that

promoted the full discussion remain unclear, and the effect on patient pain outcomes was not

measured. Further research is needed to test specific pain communication strategies essential for

practitioner pain management education.

Communication Theory Attuning Strategies Communication Accommodation Theory (CAT) has been used to guide causal research about

communication behaviors with older adults.** CAT describes the motivations and behaviors of people as they adjust their communication in response to their own needs and the perceived behavior of the other person.“**° Paying attention to the other person when communicating provides useful information that can enhance communication. This attention has been termed attuning strategies.*° Attuning strategies include discourse management and interpersonal control strategies. Discourse

management strategies involve evaluating the social aspects of the communication interaction, such as selecting and sharing a topic. Interpersonal control strategies pertain to identifying the relationship

between the communicators.

Within the context of pain management communication CAT provides strategies that

practitioners can use to enhance communication with patients. For example, practitioners could use a

topic sharing discourse management strategy by using an open-ended question to inquire about pain

PHS 398/2590 (Rev. 09/04) Page 17 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

444 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

to allow patients more freedom to respond in the way they feel most helpful in communicating their

pain. An interpersonal control strategy by practitioners would be to avoid phrasing questions about

pain in a socially desirable way, clarifying that the pain communication is taking place within a health care rather than a social context. Testing how different strategies affect pain communication between

practitioners and patients can lead to more effective use of the communication strategies to decrease

pain.

Summary the Literature Review Pain communication has emerged as an important, but poorly understood aspect of pain

management. Descriptive studies document problems with pain communication and patient related barriers to pain communication. Clinical trials have demonstrated the benefits of resource intensive

coaching interventions for patients prior to office visits. An extensive pain communication education intervention with physicians did not clarify if pain was adequately discussed, or how individual communication strategies affected pain communication. Our study addresses gaps in pain

communication research by using theory based pain communication strategies in a rigorously designed study to test how older adults’ respond to different types of health care practitioner pain

communication.

C. Preliminary Studies In nine studies, the PI has investigated different aspects of practitioner and patient

communication that might affect pain management. A summary of the findings from the nine studies includes:

co nurses’ administration of opioids after surgery is related to the patients’ race and gender; *’ eo some nurses may not attend to their patients’ specific pain information, and consequently

either omit this pain information or recall it incorrectly;*® many older adults do not plan to talk in the hospital with their practitioners about their pain;*9

adults have difficulty communicating their pain to their health care providers after surgery;> postoperative pain after discharge continues to plague many adults and might be decreased if adults understood more about pain management and possessed more effective pain communication skills;°°

co a majority of postoperative patients used exact Short-Form McGill Pain questionnaire sensory or affective words or synonyms to describe their postoperative pain;*'

eco a slide show teaching older adults about postoperative pain communication and pain

management helped decrease postoperative pain;° co a video teaching pain communication and pain management assisted older adults to

experience less sensory pain during the early postoperative period;°° co a refined video teaching pain management and pain communication skills assisted older adults

to experience less pain interference with sleep during the first postoperative day.“

The nine studies represent a wide range of methods, including post-test only experiments, patient surveys using audio taped interviews, and content analysis. Five manuscripts, °49505*54 contained in Appendix A, provide more detailed accounts of our research.

opeon oc) 8

Summary

The processes used in conducting these studies have provided excellent preparation for the implementation of the proposed research. We have recruited and retained over 320 participants

during our previous pain management studies. We have worked exclusively with older adults during

four of our recent studies, three of which were randomized controlled trials that provided us with the

expertise needed to conduct our proposed experiment. Our experience with refining our video

PHS 398/2590 (Rev. 09/04) Page 18 Continuation Format Page

APRENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 445

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

intervention teaching older adults how to communicate with practitioners about pain has prepared us to develop the videos in our proposed study as a way to standardize our experimental manipulations. Our experience in conducting content analyses with participants’ responses provides us with the skill required for content analysis of participants’ responses in our proposed study. We are well prepared to conduct our proposed study, if the science is deemed sound.

We have established pain communication between the practitioner and patient as an integral part of achieving pain relief. The results from our three pain communication intervention studies indicate that closer scrutiny of pain communication is needed to identify communication strategies that exert the greatest effect on patients and practitioners. We need to directly test specific

communication strategies in order to clarify which communication strategies encourage older adults to describe important information, and what important information is missed when health care

practitioners use ineffective communication strategies. Research based communication skills provide a more powerful way to help practitioners and older adults communicate about pain problems.

D. Research Design and Methods Our study takes the novel approach of testing patients’ responses to being asked about their

pain to determine what important information people communicate. Our innovative use of national

osteoarthritis pain management guidelines to analyze the clinical importance of the information communicated by the older adults further strengthens our proposed study. In particular we are

interested in knowing whether important pain information is omitted when practitioners use closed ended questions and/or socially phrased questions that might direct responding. Practitioners need to

be aware if pain information is gained or lost when different communication strategies are used to talk about pain. The attuning strategies from CAT provides the theoretical framework for our study,

allowing us to test two aspects of how well CAT describes the dynamic process of participating in a health care conversation about pain.

Design A posttest only double blind experiment will test how the phrasing of health care practitioners’

pain question, open-ended without social desirability, closed-ended without social desirability, or open-ended with social desirability bias, affects the pain information provided by older adults with chronic osteoarthritis pain. To control for the measurement effect, half of each of the three groups will

respond to the Brief Pain Inventory Short Form (BPI-SF) before watching the videos, and the remaining half after responding to the final video. Table 1 depicts the research design.

Sample Older adults may be even more vulnerable to pain communication difficulties with health care

practitioners.“ Inclusion criteria for the sample size of 300 consists of community dwelling adults, age 60 and older who speak, read, and understand English and who have self identified osteoarthritis pain. Exclusion criteria consists of the presence of self identified malignant pain. Older adults with malignant pain might communicate differently due to the life-threatening context of pain associated with a cancer diagnosis. A small effect size is indicated when no previous effect size is available to

base the sample size estimate upon.°° A total sample size of 300 is needed for a multivariate analysis of covariance (MANCOVA) with three groups (open-ended without social desirability, closed-ended

without social desirability, or open-ended with social desirability bias), two dependent variables (pain

information included and pain information omitted), .05 level of significance, .80 power, and small

estimated effect size.°° Over 20 million Americans have osteoarthritis.’ More than 80% of older adults over 75 have osteoarthritis.°° The feasibility is high for recruiting the required sample size.

PHS 398/2590 (Rev. 09/04) Page 19 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

446 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

Table 1 Research Design

Grou Measurements R_ open-ended and without social desirability bias (a) BP] Xa O1 X2 O2 X3 O83

R_ closed-ended and without social desirability bias (bo) BPI Xb O1 X2 O2 X3 O38

R_ closed-ended and without social desirability bias (b) XbmO1iexXZ ee OZGe Xs avOSeMBE|

R_ open-ended and with social desirability bias (c) ae Xe Ol 7x2 ©O2 X3 WE R_open-ended and with social desirability bias (c) XCmO ine XZ © 2s XGaen © Sameb et

R = Random assignment BPI = Brief Pain Inventory measure for covariates, pain intensity and interference with activities

Xa = Video with open-ended without social desirability bias

Xb = Video with closed-ended without social desirability bias Xc = Video with open-ended with social desirability bias O1 = Verbal response to the video clip practitioner pain question O2 = Verbal response to the video clips about additional information in general O3 = Verbal response to the video clips about additional information specific to pain

X2 = General additional information question

X3 = Pain specific additional information question

Procedure We will first describe the overall procedure to provide context for our video experimental

manipulation. We will then describe our measures, followed by our plans for content analyses and

statistical analyses.

Recruitment. Eligible older adults will be recruited from independent housing sites in Hartford, Bridgeport,

New Haven, and suburban areas of Connecticut. The registered nurse doctoral student graduate assistant (GA) will screen for eligibility, give the older adult an enlarged print copy of the informed consent, and secure informed consent. Screening will include asking participants to self identify if

they experience pain from osteoarthritis. To avoid priming participants about how to describe their

pain, a yes/no question will be used to screen for osteoarthritis pain, “Do you have pain from

osteoarthritis?” Participants will also be asked if they have any cancer pain, “If you have been diagnosed with cancer, do you have any pain from cancer?” Participants with malignant pain will be

excluded from the study. Participants will be asked their age. Consenting, eligible participants will be automatically randomized to one of the three conditions by the SuperLab 3.0 computer software

program, keeping the GA blind to the condition.

A cover story will be given to each older adult to increase experimental realism and to

decrease the introduction of response bias. Participants will be told that the study is testing the feasibility of helping people prepare for their health care office visit while waiting in the office for their

appointment. The GA will make the following statement. “We are testing whether asking patients to respond to a video of a health care practitioner asking questions about your health prior to an office visit helps you communicate better during the office visit.”

Our cover story provides experimental realism by providing a credible reason for asking older adults to watch and respond to a computer video clip of a health care practitioner. Closely

approximating a real life clinical situation increases the likelihood that responses from participants will be similar to their responses to health care practitioners during actual pain communication in the

PHS 398/2590 (Rev. 09/04) Page 20 = Continuation Format Page

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 447

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

Clinical setting. Successful patient coaching interventions prior to office visits have been reported,” making the cover story more credible.

Experimental Manipulation and Measurement.

The use of a video clip to provide the experimental manipulation strengthens the study by controlling for differences that occur across repeated live presentations of the same condition,

strengthening fidelity°’ to the treatment. The use of video clips controls for any experimenter demand effects by standardizing the way participants are asked about pain in each condition. The use of the health care practitioner title increases the applicability of the findings to both nurse practitioners and physicians. Each of the three video clips will be subjected to a review panel of primary care nurse

practitioners and physicians to determine the face validity of the practitioner posed question, and the similarity of other aspects of the clips. The use of the video clip reduces the cost of an additional GA to personally administer the experimental manipulation.

Our method avoids the problem of using patient analogues,” people who are asked to imagine themselves as having chronic pain. Responses from patient analogues might not be generalized to

people with chronic pain, because patient analogues might not accurately grasp the experience of chronic pain.

The GA will test the audio tape recorder to insure that participants’ voices are clearly and

completely recorded. The GA will explain that the participant is going to watch three video clips of a health care practitioner on the computer screen and verbally respond to the practitioner's question in

each clip before proceeding to the next clip. The participant's response will be audio taped. Participant will be instructed to touch any area of the screen to proceed to the next question, after

they have responded to each question. We chose a touch screen for the increased ease of use especially for older adults with osteoarthritis in their hands. The final screen will instruct participants to

press the buzzer placed on the table beside the computer to signal the GA to return to the room. After providing the instructions, the GA will use a test video to adjust the sound to a comfortable, audible

level for each participant. The GA will start the audio tape recorder, press the computer to start the video clip and then leave the room. There will be a 15 second delay before the video clip begins.

During that time, the participant will be randomly assigned to one of the three conditions through use of the SuperLab 3.0 software. The computer software can be programmed to randomly assign treatments to participants, and provide an experimental treatment (the video tape clips). The ability to

use video clips as stimuli and randomly assign older adults to condition make the software a valuable

resource for our study.

The randomized video clip will begin and the condition will be audio-recorded allowing the PI to later determine the participant’s condition. The participant will respond to the practitioner's question about their pain, and the verbal response will be audio taped. The question will consist of one of the

following, corresponding to the three experimental conditions. co Tell me about your pain, aches, soreness, or discomfort. (open-ended and without social

desirability) co What.would you rate your pain, aches, soreness, or discomfort on a 0 to 10 scale with 0, no

pain, and 10 the worst pain possible? (closed-ended and without social desirability bias)

co How are you feeling? (open-ended and with social desirability bias)

The second part of each practitioner video will consist of the practitioner asking all participants, “What

else can you tell me?” The third and final part of the practitioner video will consist of the practitioner

asking, “What else can you tell me about your pain, aches, soreness or discomfort?” Responses to all

three questions will be audio-recorded. Participants will be instructed by the GA to press the screen

PHS 398/2590 (Rev. 09/04) Page 21 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

448 APPENDIXN #® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

to proceed to the next question, after fully responding to each question. The final screen will instruct

participants to press the buzzer placed beside the computer after responding to the third and final

question. The buzzer will signal the GA to return to the room. A separate audiotape will be labeled for

each participant.

Brief Pain Inventory Short Form (BPI-SF) Pain Measure. The GA will orally administer the BPI-SF to measure participants’ pain at the present time.

Measuring participants’ present pain with the BPI-SF allows us to control for pain differences across

participants. Participants might learn how to better describe their pain by responding to the BPI-SF, but might also respond differently to the BPI-SF after viewing and responding to the videos. We will

randomly counterbalance the BPI-SF measure to control for these potential learning effects. Fifty participants from each of the three experimental groups will respond to the BPI-SF after responding to

the final video. The remaining 50 participants from each group will respond to the BPI-SF prior to

watching the first video (experimental manipulation). The PI will randomize timing of the BPI-SF with

a computer program for random assignment and compile a list that indicates, by order of entry into the study, whether the BPI-SF will be administered prior to watching the videos or after responding to

the third and final video.

Demographic information will be measured last. The GA will orally ask the demographic questions and record responses on a demographic form. The BPI-SF, and demographic form will be coded with the same number used to identify the participant’s audiotape.

Upon completion of all of the measures, the following protocol will be followed by the GA for participants who report present pain intensity on the BPI-SF at a level of four or greater. The GA will encourage the older adults to talk with their health care practitioner about their pain problem. If

participants state that they do not have a health care practitioner, the name, location and telephone

number of nearby accredited ambulatory care clinics will be given in writing to participants, with encouragement to make an appointment. If participants state that they have no health care insurance

to pay for an office visit, the name, location and telephone number of a nearby sliding scale community health clinic will be given to them in written form.

Debriefing.

After completing the demographic information, the GA will debrief each participant. Participants

will be thanked for their help. The debriefing will first include checking for hypothesis guessing by

asking participants what they thought the study was about. Data from any participants guessing what the study was about will be marked and will not be used in the analysis. The study will be completely explained to participants, along with the reason for the deception. Participants will be checked for any concern or distress about the deception used in the study, and reminded that they are free to

withdraw from the study. Participants will be asked not to discuss the study with people living in the housing development, because they might participate in the study. Participants will be asked if they

have any questions or comments to make about the study. Participants will be thanked for their participation in the study, given a personal copy of the Arthritis Foundation publication, Managing

Your Pain,°' compensated for their time with a $20 money order, and informed that their participation has been completed.

Video Clip Experimental Manipulation A video clip presented on a touch screen equipped laptop computer monitor will be used for

the experimental manipulation. Prior to leaving the room, the GA will adjust the sound, using a video clip not associated with the experimental manipulation with the same sound volume of the three

PHS 398/2590 (Rev. 09/04) Page 22 Continuation Format Page

APPENDIXN Health Care Practitioner Pain Communication: R21 Grant Application 449

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

experimental video clips. The GA will adjust the sound volume to a level that allows each participant to clearly hear the video.

A brief health care office visit scene will be depicted. The same practitioner will be videoed for each of the three conditions. The conditions will be identical except for how the practitioner asks patients about their pain. Each condition will start out with the practitioner entering the examination

room and sitting down in a chair to face the camera (participant). The practitioner will say, “Hello, | am going to ask you some questions about your health.” After a slight pause, the practitioner will ask about the participant’s pain (the experimental manipulation). The practitioner will use the same volume, voice inflection and nonverbal communication when asking each of the three questions. The three video clips will be reviewed by a group of five primary care nurse practitioners and primary care physicians for face validity and for equality of practitioner nonverbal behavior and verbal behavior such as tone, and voice inflection.

The practitioner will ask only one question in each condition. The three questions representing each of the three conditions are as follows:

co Tell me about your pain, aches, soreness, or discomfort. (open-ended and without social desirability)

co What would you rate your pain, aches, soreness, or discomfort on a 0 to 10 scale with 0, no pain, and 10 the worst pain possible? (closed-ended and without social desirability bias)

co How are you feeling? (open-ended and with social desirability bias)

An alternative approach would be to embed the pain questions within a more prolonged discussion by the practitioner. Further discussion would burden participants with a longer time to

complete the study. Additional general health care discussion would also require participants to reveal personal health information unnecessary for the purposes of the study. To increase privacy of

health information and decrease burden for participants, we chose to place the pain question at the beginning of the discussion. It would be reasonable for a practitioner to ask older adults with

osteoarthritis pain about their pain at the beginning of the visit.

We also chose to leave the health care practitioner credentials ambiguous, rather than specifying the practitioner as a physician or a nurse practitioner. The ambiguity allows us to extend

the applicability of the findings to both physicians and nurse practitioners.

Measures

Content Analysis of Included Pain Information. Participants’ verbal response to the practitioner's pain question will be audio taped and

transcribed for content analysis. Content analysis for included pain information is described in the

section on content analysis.

Content Analysis of Omitted Information. Two questions will be used to measure additional information that participants communicate,

when given the opportunity. After responding to the practitioners’ pain question, all of the older adults

will watch and listen to a second video clip of the practitioner asking, “What else can you tell me?”

Next all participants will respond to a third video clip of the practitioner asking the participant, “What

else can you tell me about your pain, aches, soreness or discomfort?” Responses to both questions

will be audio taped and transcribed for content analysis. Participant responses to additional

information might be increased if measured in a face-to-face interview. Use of the same practitioner

PHS 398/2590 (Rev. 09/04) Page 23 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

450 APPENDIX N ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

video clip format decreases the confounding influence of different measurement methods. Content

analysis for omitted pain information is described in the content analysis section.

Brief Pain Inventory Short Form (BPI-SF).

The GA will use the BPI-SF to measure participants’ present pain intensity and present pain

interference with activities. The BPI-SF was developed to examine the prevalence and severity of

pain in the general population.® The BPI-SF consists of 15 questions that measure pain location, intensity, pain treatment, and the effect of pain on mood and every day activities. The first question

asks if the person has had any pain today. An anterior and posterior body diagram allows the respondent to shade areas where they feel pain and mark with an “X” the area that hurts the most. Respondents rate their worst, least, and average pain in the past 24 hours using a 0 — 10 numeric rating scale with 0, no pain, and 10, pain as bad as you can imagine. They also rate their pain right

now. An open-ended question asks what.treatments or medications they are receiving for their pain. Respondents then rate the percent of relief they received from the treatments in the past 24 hours.

The seven remaining questions evaluate how pain has interfered with activities including general activity, mood, walking, work, relations with others, sleep and enjoyment of life. Anchors for the 0 — 10 scale consist of 0, does not interfere and 10, completely interferes. Zalon®? compared the BPI-SF with the Short Form McGill Pain Questionnaire (SF-MPQ) with a group of surgical patients. The correlation

between the BPI-SF and the SF-MPQ for pain over the previous 24 hours was .61, p < .001, supporting concurrent validity. Cronbach’s alpha for the overall BPI-SF has been reported as .77 to

.87.°° The BPI-SF is in Appendix B.

Demographic Form. Older adults’ demographic information will be measured last. The GA will ask participants to

provide the following information: age, gender, race, ethnic group, marital status, highest completed education, if they are currently followed by a health care practitioner for their osteoarthritis and

osteoarthritis related pain. The Demographic Form is in Appendix C.

Content Analysis Krippendorff's® components for content analysis will be used to conduct the content analysis

of older adults’ responses to the practitioner's question about pain and the two follow up questions.

The content analysis components include unitizing, sampling, coding, and inferring. The way in which

each of the components will be used in the analysis is described below.

Unitizing.

The unit of analysis for the content analysis will be any word or phrase that describes one of

the a priori criteria. One point will be given for each word or phrase describing a criterion. Repeated use of the same word or phrase will be counted only the initial time to avoid inflating the

communication score. Each distinctly different word or phrase about the same criterion will be credited with one point. The statement, “I start each day off by taking two Tylenol and placing a hot

pack on my knee while | eat my breakfast.” would be coded for current pain treatments with one point for the Tylenol and one point for the hot pack. One additional point would be coded for the word knee, which addressed the pain location criterion.

Sampling.

All transcripts of older adults’ response to the way that the nurse practitioner asked them about their pain will constitute the sample for content analysis of included pain information. The initial

practitioner question will be skipped over on the audiotape and omitted from the transcript. The persons conducting the content analysis will remain blind to participants’ condition until the content

PHS 398/2590 (Rev. 09/04) Page 24 Continuation Format Page

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 451

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

analysis is complete, at which time the experimental condition will be identified directly from the audiotape. Text will be read at the level of words and phrases to identify important content for management of osteoarthritis pain. The same process will be used for responses to the practitioner question asking if there is anything further they want to say (omitted pain information). The same process will be used a third time for responses to the final practitioner question about if there is anything further about their pain that they would like to say (omitted pain information).

Coding. The American Pain Society (2002) Guidelines for the Management of Pain in Osteoarthritis,

Rheumatoid Arthritis, and Juvenile Chronic Arthritis® will be used to identify important osteoarthritis

pain management content included or omitted from older adults’ transcribed responses to the practitioner’s pain communication question. The Guidelines are the culmination of expert review of

the Cochrane Collaboration Reviews, additional published systematic reviews, American Pain Society (APS) commissioned reviews, and reviews conducted by the expert 10 member interdisciplinary panel and APS staff. The a priori osteoarthritis pain management criteria include:

1. Type of pain (nociceptive/neuropathic);

Quality of pain; Pain source; Pain location; Pain intensity;

Duration/time course; Pain affect;

Effect on personal lifestyle; . Functional status;

10. Current pain treatments; 11.Use of recommended glucosamine sulfate;

12. Effectiveness of prescribed treatments;

13.Prescription analgesic side effects; 14.Weight management to ideal body weight; 15.Exercise regimen, or physical therapy and/or occupational therapy;

16.Indications for surgery.

SON COT ODIO IE SB COAhS

QRS N6 (NUD*IST) will be used to manage the content analysis and organize the coded data.

The node system will be composed of the a priori codes listed above. Included pain communication

content (responses to the first practitioner question) will be coded by highlighting the content and marking the content with a number representing the criterion. The criterion number will be placed at

the end of the word or phrase (e.g. pain in my right knee 4; | take Tylenol extra strength10; The Tylenol dulls the pain a little bit 12). A subscript will indicate if the item is the first, second, and so on item for the criterion described by that participant. After coding each participant's responses, the coder will check all coded content on the same criterion to identify repeated instances of coding identical content. Identical content will be coded only one time for each participant. The same procedure will be used to code omitted pain communication content (responses to the second and third practitioner questions). Content will be coded separately for the second question and for the

third practitioner question.

Reducing.

Coded data will be entered into an SPSS database. The number of distinct content for each

criterion will be entered into the database. Separate sets of variables will be entered for content

analyzed from responses to the practitioner pain question, responses to the practitioner's general

PHS 398/2590 (Rev. 09/04) Page 25 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

452 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

follow up question, and responses to the practitioner’s pain specific follow up question. Frequencies will be used to further reduce the data. The included pain communication score will be calculated by

summing all of the important pain content described by participants in response to the practitioner

pain question (first question). The omitted important pain information will be calculated by summing

all important pain content described by participants in response to the practitioner's two follow up

questions.

Inferring. The American Pain Society (2002) Guidelines for the Management of Pain in Osteoarthritis,

Rheumatoid Arthritis, and Juvenile Chronic Arthritis® provides the research-based criteria for coding

the data. The PI will train the GA to conduct the content analysis. The PI and the GA will independently code all of the responses, remaining blind to participants’ conditions. The PI and GA

will compare the codes. The PI will document each instance of coding disagreement. Disagreements

will be resolved through discussion. Inter-rater reliability will be calculated, as described in the

analysis section.

Summary of the Methods Older adults with chronic osteoarthritis pain will be randomly assigned to one of three

practitioner pain communication conditions. Participants will watch and verbally respond to a video

clip of a practitioner asking them about their pain with either an open-ended question without social

desirability bias; closed-ended question without social desirability bias; or open-ended question with social desirability bias. All participants will respond next to a video clip of the practitioner asking them

if there is anything further they want to say, and finally to a video clip of the practitioner asking them if

there is anything more about their pain that they want to say. The GA will administer the BPI-SF to

half of each of the three groups prior to watching the videos, and to the remaining half of each group after responding to the final video, to measure and control for present pain differences in participants

across groups, and to counterbalance the effect of the BPI-SF measure. Verbal responses to all three video clips will be audio taped and transcribed. Important included pain information (responses to the

first video) and omitted pain information (responses to the second and third videos) will be content analyzed by two trained independent raters, blind to participants’ conditions. A priori criteria derived from national osteoarthritis pain management guidelines will be used to code the responses. Our methods provide a context with strong experimental realism to test theory driven pain communication

skills for the effect on information included and omitted by older adults important in managing osteoarthritis pain.

Analysis

The characteristics of the sample will be summarized and described with frequencies, (and means and standard deviations for interval level measures) for the descriptive data. These data

includes age, gender, race, highest education completed, and if participants are currently followed by a health care practitioner for their osteoarthritis and osteoarthritis related pain.

Inter-rater reliability will be calculated using Krippendorff's alpha to compare the equivalence of

coding between the independent raters, the PI and GA. Krippendorff's alpha is calculated by the following formula, « = 1 — (D./De) where Do is the measure of observed disagreement and D.is the

measure of the disagreement expected by chance. Krippendorff’s alpha corrects for chance, and can be used with large sample sizes.

A check for randomization to condition will be conducted prior to the main analyses to test for significant pre-existing differences between older adult participants in the three conditions:

PHS 398/2590 (Rev. 09/04) Page 26 aay Continuation Format Page

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 453

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

health care practitioner open-ended without social desirability bias pain question; 2. health care practitioner closed-ended without social desirability bias pain question:

3. health care practitioner open-ended with social desirability bias pain question.

Analyses of variance (ANOVA) will test for age differences between the three groups. Cross tabulation using the chi-square statistic will be used to test for differences between the groups for gender, race, ethnicity, highest education achieved, followed/not followed for osteoarthritis by a health care practitioner, and followed/not followed for osteoarthritis pain by a health care practitioner.

The timing effect of the BPI-SF will be tested by ANOVAs on the variables of pain intensity, interference with activities, and responses to practitioner questions about pain (included and omitted information). Each ANOVA will have two factors (groups and timing) and their interaction. Thus, a single ANOVA will test for group differences on a specific dependent variable, timing differences, and the possibility of an interaction, i.e., that one of the groups showed a stronger timing effect than the other. However, a strong interaction is not expected.

Hypothesis

Hypothesis: Older adults asked about their pain with an open-ended question without social

desirability bias will describe more important pain information and omit less information than older adults asked about their pain with a closed-ended question without social desirability or an open- ended question with social desirability bias.

The hypothesis will be tested with a multivariate analysis of covariance (MANCOVA). The grouping variable consists of three groups: 1. health care practitioner open-ended without social

desirability bias pain question; 2. health care practitioner closed-ended without social desirability bias pain question; 3. health care practitioner open-ended with social desirability bias pain question. The

two participant response measures will comprise the input for the multivariate vectors for comparison. The two response measures include: 1. the content analysis summed scores of important osteoarthritis pain information described by the participant in response to the practitioner's pain

question; and 2. important omitted pain information measured by responses to the second and third

questions about any further information. Present pain intensity and pain interference with activity will be used as covariates to control for pain differences between participants. If timing of the BPI-SF is significant, timing of the BPI-SF will be entered as a covariate. If important pre-existing group differences occur during the preliminary analyses, the variable will also be used as an additional

covariate to adjust for the differences. Descriptive discriminant function analysis (DFA) following significant results from the MANCOVA will provide a multivariate way to interpret group differences

that result from MANCOVA,® maintaining a more rigorous analysis than possible with post hoc univariate analyses. Post hoc DFA involves examination of the correlation between the discriminant function and the pain communication variables, examination of the canonical discriminant function coefficients for lack of redundancy, interpretation of the group centroids, and group membership

classification.

Summary of the Analyses A summary of the data analysis includes: 1) describing and summarizing the participating older

adults with descriptive statistics and frequencies; 2) computing the inter-rater reliability for coding

participant responses; 3) checking that randomization to condition resulted in no significant

differences between the groups; 4) checking that the timing of administering the BPI-SF had no

significant effect; 5) testing the hypothesis related to important pain information provided and omitted

by participants with a MANCOVA, using present pain intensity and pain interference with activities as

PHS 398/2590 (Rev. 09/04) Page 27 — Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

454 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

covariates, and using DFA as a multivariate technique to interpret the differences if the MANCOVA is

significant.

Study Summary Our study provides an innovative controlled test of how older adults respond to pain

communication strategies used by health care practitioners. Following informed consent, older adults with osteoarthritis pain will be randomly assigned to one of three groups. Participants will watch and verbally respond to: (1) one of three video clips of a practitioner asking them about their pain (a. open-ended and without social desirability bias, b. closed-ended and without social desirability bias, or c. open-ended and with social desirability bias); (2) a video clip asking, “What else can you tell me?” (3) a video clip asking, “What else can you tell me about your pain, aches, soreness or discomfort?” All responses to the videos will be audio taped. The GA will counterbalance the BPI-SF

measure by orally administering the BPI-SF to a randomly selected half of each of the three groups prior to the videos, or after responding to the final video. The GA will administer the demographic measure as the final measure. The GA will debrief each participant, thank them for their contribution to the study, and compensate each person for their time with a $20 money order and a copy of the

Arthritis Foundation Managing Your Pain publication. Content analysis will be conducted on the transcribed audiotapes to identify important pain information included in the response to the initial

pain question (included information), and important information included in the response to the two follow up questions (omitted information). The summed scores for included and omitted information will be entered into the MANCOVA comparing the three groups for differences in older adult pain

communication responses, using current pain intensity and pain interference with activities as

covariates. The goal is to identify practitioner pain communication strategies that allow patients to describe pain information important for guiding effective pain management, and to substantiate what

pain information is missed when practitioners use less effective pain communication. The results will provide empirically tested theory based communication strategies that can be used in pain

communication education for patients. Our study has the potential to inform curriculum across a number of health care practitioner groups, including nursing and medicine. Effective communication

between older adults and health care practitioners provides the link for significantly reducing or eliminating pain. Table 2 presents the timeline for completing our study.

Table 2 Study Timeline

Activity Time

5/1/06 8/1/06 9/1/06 8/31/07 12/1/07 3/1/08 4/30/08 1. Video clips developed, X reviewed for face validity, & edited

2. SuperLab software loaded & tested X2 3. GA trained, data collected & transcribed X3

4. Content analysis X4

5. Statistical analyses X5 6. Manuscript preparation Xe

7. R21 final report X7 Note. The time for a listed activity extends from the start date of that activity to the start date of the following activity.

PHS 398/2590 (Rev. 09/04) Page 28 Continuation Format Page

APPENDIXN # Health Care Practitioner Pain Communication: R21 Grant Application 455

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

E. Human Subjects Research

Overview

The study involves the participation of community dwelling older adult with osteoarthritis pain but no cancer pain (malignant pain). The risks, adequacy of protection, and potential benefits will be presented, followed by the importance of the knowledge that might be gained. The GA will recruit older adults from elder independent housing sites in Hartford, New Haven, Bridgeport, and suburban areas in Connecticut.

1. Risk to the Subjects

Human Subjects Involvement and Characteristics.

The GA will recruit community dwelling adults, age 60 and older who have osteoarthritis pain but no malignant pain who speak, read, and understand English. Recruitment will be through housing

newsletter announcements, posted materials, and direct contact in the public areas of the housing sites. We selected Hartford, Bridgeport, and New Haven as sites for our study to increase

representation of Black or African American, Hispanic, and Asian Americans. Older adults interested in participating in the study will be screened for eligibility, receive informed consent, and make an

appointment for the GA to conduct the study in the older adults’ home. Older adults will be recruited until a total of 300 eligible participants have completed the 15-minute study. The age range is anticipated to be from 60 to 90.

Before beginning the study, the GA will again provide oral informed consent and include written consent with an enlarged print consent form. The GA will instruct the participant to listen and

respond in turn to each of three separate video tape clips and press the buzzer after responding to the third and final video clip. Participants will be randomly assigned to one of the three treatment conditions by the SuperLab 3.0 software. All responses will be audio taped. When the participant is ready, and after the video sound level has been adjusted, the GA will start the video clip and leave

the room. The first video will begin 15 seconds later. A video clip of a health care practitioner will ask participants about their pain in one of three ways. After responding to the practitioner, participants will

touch the screen and view and listen to the practitioner ask them, “What else can you tell me?” After responding to the practitioner, participants will touch the screen again and view and listen to the third

and final clip of the practitioner asking them, “What else can you tell me about your pain, aches, soreness or discomfort?” After completing their response, participants will ring the buzzer and the GA

will return to the room and turn off the audio tape recorder. The GA will orally administer the BPI-SF to measure present pain, if the BPI-SF was not administered prior to the videotapes, and administer the Demographic Form as the final measure. The GA will then debrief the participant, checking for hypothesis guessing, more fully explaining the study, assessing for any discomfort, and requesting

that they do not talk about the study in case others wish to participate. Participation in the study will be complete after the debriefing. Participants will be thanked and given the Arthritis Foundation publication, Managing Your Pain,®' and a $20 money order for participating in the study. Older adults are exclusively studied because they have been identified as having more difficulty in communicating

about their pain.*? The 80% incidence of osteoarthritis in people over 75°° makes older adults highly vulnerable to pain problems, and a high priority for pain communication studies. Osteoarthritis occurs

much less frequently in younger and middle aged adults, and is unlikely to occur in children.

Source of Materials. Three instruments will be used to gather individually identifiable data for the purpose of the

study. The GA will audiotape participants’ verbal responses to the three videos which will be content

PHS 398/2590 (Rev. 09/04) Page 29 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

456 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

analyzed to extract the two dependent variables, included and omitted important pain information.

The GA will orally administer the BPI-SF to measure the two covariates, present pain intensity, and pain interference with activities. The GA will orally administer the Demographic Form to record demographic variables including age, gender, race, ethnic group, marital status, highest completed

education, if they are currently followed by a health care practitioner for their osteoarthritis and osteoarthritis related pain. Names will not be linked to the data. A number code will be used to link the audio taped responses and the responses to the BPI-SF and the Demographic Form for each participant. The GA will be absent from the room when participants are audio taped. Only the PI and

GA will have access to the data. The audiotapes and the written data will be kept locked in the PI's office at the University of Connecticut. The data will be analyzed on the Pl’s university office computer, which is secured with password protection. The data will be collected specifically for the

proposed study.

Potential Risks. The intervention involves minimal risk. The practitioner questions comprising the experimental

manipulation are commonly used questions about pain that participants have likely responded to

before during health care visits. The BPI-SF questions about pain include common areas of pain

assessment such as pain intensity, and how the pain interferes with daily activities. The entire study takes approximately 15 minutes to complete. The study will take place in the older adults’ homes at a time convenient for them. All participants will be debriefed to check for any psychological discomfort

with the study, and to allow participants to withdraw if they so wish. If at any time older adults do feel burdened, they are free to withdraw from the study.

2. Adequacy of Protection Against Risks

Recruitment and Informed Consent. The GA will recruit participants through housing newsletter announcements, posted materials

and direct contact in the public areas of the independent elder housing sites. Older adults interested

in participating in the study will be screened for eligibility, receive informed consent, and make an appointment for the GA to conduct the study in their home.

The GA will use the cover story that we are testing the feasibility of helping people prepare for their health care office visit while waiting in the office for their appointment. The GA will make the

following statement. “We are testing whether asking patients to respond to a videotaped health care

practitioner asking questions about your health just prior to an office visit helps you communicate better during the office visit.”. The mild deception is warranted to increase the experimental realism

and decrease response bias. The GA will explain that the study involves privately watching three brief

video clips of a practitioner asking them health questions on a laptop computer screen. Participants

will verbally respond after each clip and responses will be audio taped. When they have finished responding to the third clip, the GA will return to the room and ask them questions about pain problems, and general information such as their age and marital status. Their participation will then be complete and no other contact will be requested. The entire study takes about 15 minutes. No

names will be linked with any information provided by participants. All information will remain

confidential. The information will be kept secure in the University of Connecticut office of Deborah Dillon McDonald. Older adults will be reminded that participation is voluntary. They do not have to be in the study if they do not wish to be. They can withdraw from the study at any time without risk. They

will be given an enlarged type copy of the written consent form to keep. The consent form will contain the name and contact office telephone number of the PI and the University of Connecticut IRB, if

PHS 398/2590 (Rev. 09/04) Page 30 Continuation Format Page

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 457

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

participants have questions. Older adults willing to participate will be asked to sign the consent form after reviewing the form and receiving informed consent from the GA.

Protection Against Risk.

Several safeguards have been designed into the study to protect participants from risk. The GA will not be present in the room while participants respond to the video clips. After completing the

demographic information, each participant will be debriefed by the GA. The study will be completely explained to participants, along with the reason for the mild deception. Participants will be checked for concern or distress about the mild deception, and reminded that they are free to withdraw. No names will be written on any of the collected data. Identification numbers will be assigned by the GA and

used to link the three sources of data from each individual. All collected data will be kept confidential and will be locked in the Pl’s university office.

A referral protocol will be followed in cases where participants describe moderate or greater

present pain problems (pain levels of 4 or greater on the 0 to 10 BPI-SF). The protocol will include the registered nurse GA encouraging: (1) the person to contact their primary care provider to assess and

treat the problem; (2) if the person has no primary care provider, a list of names and telephone numbers of local accredited ambulatory care clinics will be given if the person; (3) if the person has

no insurance, the name and telephone number for a local community health clinic providing sliding scale health care will be given to the person.

3. Potential Benefits of the Proposed Research to the Subjects and Others

Testing how older adults respond to the way health care practitioners ask them about their pain, and whether important information is included or omitted provides a critical starting point for

educating patients and practitioners about more effective ways to communicate about pain. Patients who are able to communicate important information about their pain are more likely to be prescribed more effective pain treatments and achieve greater pain relief. Consumer pain management

resources such as the Mayday Foundation web site and existing coaching interventions could easily

incorporate the communication strategies. The effective pain communication strategies could be incorporated into nursing, medical, pharmacy, and allied health curricula.

Older adults participating in the study might become more aware of the importance of

communicating important aspects of their pain to their health care practitioner. The experience of responding to the practitioner might provide a helpful rehearsal for talking with their health care

practitioner. The BPI-SF indicates several important components for pain assessment that participants could include when discussing their pain problems. All participants will be given a copy of

the Arthritis Foundation Managing Your Pain 2003 publication. The publication provides helpful information for decreasing osteoarthritis pain, and has been approved by the American College of Rheumatology. A registered nurse GA will collect the data. The GA will use the referral protocol to encourage participants to get effective treatment for their pain, if participants describe moderate or

greater pain intensity.

The risks are minimal for older adult participants. The study takes place in participants’ homes at a time convenient to them. We use a mild deception to maintain experimental realism and to avoid response bias. Participants are debriefed and given the opportunity to withdraw from the study at any

time, including after the debriefing. The burden for participants is low. The time requirement is 15

minutes, and only verbal responses are required.

PHS 398/2590 (Rev. 09/04) Page 31 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

458 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

4. Importance of Knowledge Gained Pain communication has been identified as important for effective pain management, but

specific communication factors contributing to effective pain management have not been tested. Our study takes the novel approach of testing specific pain communication skills derived from Communication Accommodation theory attuning strategies, for the effect on important included and omitted pain information described by older adults with osteoarthritis pain. Previous pain

communication research has generally taken a macro approach, testing general pain communication content and/or increasing patients’ confidence in communicating with their health care practitioner.

We take a micro approach and link the effect of two specific pain communication strategies, discourse management (open ended/closed ended) and interpersonal control (with social desirabilityAwithout

social desirability bias), to pain information identified by the American Pain Society® as important

information in the management of osteoarthritis pain. Our study provides the opportunity to advance

our understanding of pain communication by testing Communication Accommodation theory, and improve pain management by incorporating into health care practice the simple strategies tested in

our study. The strategies can be taught to health care practitioners and older adults with chronic pain.

The results might have implications for acute pain and malignant pain communication.

The risk for older adult participants is minimal. Participation requires only 15 minutes. Older

adults are asked to respond to questions similar to those encountered during their usual health care.

Inclusion of Women and Minorities Selection criteria for our study include women and minorities. Our selection criteria include any

community dwelling adult age 60 or older and who have pain from osteoarthritis who can speak, read,

and understand English. Osteoarthritis commonly occurs with adults, age 60 and older.® People with cancer pain are excluded from the study. Older adults are more vulnerable to problems communicating about their pain. Osteoarthritis is a pain producing condition that crosses gender,

racial, and ethnic groups, with high incidence in the older adult population. Women and men will both

be recruited for the study. The selection criteria include Hispanics, and also include African or Black Americans, Asian Americans, and members of other minority groups.

In an effort to include more participants from minority groups, independent living housing sites

will be included from Bridgeport and New Haven, Connecticut. According to the most recent census data, Bridgeport consists of 30.8% Black or African Americans, and 31.9% Hispanic, and New Haven consists of 37.4% Black or African Americans, and 21.4% Hispanic or Latinos.°°°’ We expect that recruitment in these two cities will increase the ethnic and racial representation of our sample.

PHS 398/2590 (Rev. 09/04) Page 32 as Continuation Format Page

APPENDIXN #® Health Care Practitioner Pain Communication: R21 Grant Application 459

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

Targeted/Planned Enrollment Table

This report format should NOT be used for data collection from study participants.

Study Title: Older Adults’ Response to Health Care Practitioner Pain Communication

Total Planned Enrollment: 300

TARGETED/PLANNED ENROLLMENT: Number of Subjects

Ethnic Category Sex/Gender

| Females | Males | Total _| Hispanic or Latino

Not Hispanic or Latino

Ethnic Category: Total of All Subjects *

Racial Categories

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Racial Categories: Total of All Subjects *

* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”

PHS 398/2590 (Rev. 09/04) Page 33 Targeted/Planned Enrollment Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

460 APPENDIXN #® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

Inclusion of Children

Exclusion of children from our study is justified because the research aim is to test how older

adults with osteoarthritis pain respond to pain communication strategies used by health care

practitioners. Older adults have been identified as more vulnerable to pain communication problems,

and have a high incidence of osteoarthritis, a painful condition associated with aging. Children are much less likely to suffer from osteoarthritis pain, and would not allow generalization of data.

F. Vertebrate Animais

N/A

; G. Literature Cited

1. Davis G, Hiemenz M, White T. Barriers to managing chronic pain of older adults with

arthritis. J Nurs Scholarsh. 2002;34:121-6. 2. de Rond M, Wit R, Van Dam F, Muller M. A pain monitoring program for nurses:

effects on communication, assessment and documentation of patients’ pain. J Pain Symptom

Manage. 2000;20:424-439. 3. McDonald D, McNulty J, Erickson K, Weiskopf C. Communicating pain and pain management

needs after surgery. App/ Nurs Res. 2000;13:70-75. 4. Sherwood G, Adams-MecNeill J, Starck P, Nieto B, Thompson C. Qualitative assessment of

hospitalized patients’ satisfaction with pain management. Res Nurs Health. 2000;23:486-495. 5. Bertakis K, Azari R, Callahan E. Patient pain in primary care: Factors that influence

physician diagnosis. Ann Fam Med. 2004; 2:224-230. 6. Apfelbaum J, Chen C, Mehta S, Gan, Tong J. Postoperative pain experience: Results From a

national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97:534-540.

7. Leveille S, Ling S, Hochberg M, Resnick H, Bandeen-Roche K, Won A, Guralnik J. Widespread musculoskeletal pain and the progression of disability in older disabled women. Ann Intern Med. 2001;135:1038-46.

8. American Pain Society. Guidelines for the Management of Pain in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Chronic Arthritis. Glenview, IL: American Pain Society; 2002.

9. Desbiens N, Wu A, Yasui, Y, Lynn J, Alzola C, Wenger N, Connors A, Phillips R, Fulkerson W. Patient empowerment and feedback did not decrease pain in seriously ill hospitalized adults. Pain. 1998;75:237-246.

10.Carlson J, Youngblood R, Dalton J, Blau W, Lindley C. Is patient satisfaction a

legitimate outcome of pain management? J Pain Symptom Manage. 2003; 25(3):264-275. 11.Detmar S, Muller M, Wever L, Schornagel J, Aaronson N. Patient-physician communication during

outpatient palliative treatment visits. JAMA. 2001;285: 1351-1357.

12.Kimberlin C, Brushwood D, Allen W, Radson E, Wilson D. Cancer patient and caregiver experiences: communication and pain management issues. J Pain Symptom Manage. 2004;28:566-578.

13.Rogers M, Todd C. The ‘right kind’ of pain: talking about symptoms in outpatient oncology consultations. Palliat Med. 2000;14:299-307.

14.Kenny D. Constructions of chronic pain in doctor-patient relationships: bridging the communication chasm. Patient Educ Couns. 2004;52:297-305.

15.Branch M, Carlson C, Okeson J. Influence of biased clinician statements on patient report of referred pain. J Orofac Pain. 2000;15:120-127.

16. Jairath N, Kowal N. Patient expectations and anticipated responses to postsurgical

PHS 398/2590 (Rey. 09/04) Page 34 Continuation Format Page

APPENDIXN Health Care Practitioner Pain Communication: R21 Grant Application 461

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

pain. J Holist Nurs. 1999;17(2);184-196. 17.Zalon M. Pain in frail, elderly women after surgery. Image J Nurs Sch.1997; 29, 21-26. 18.Manias E, Botti M, Bucknall T. Observation of pain assessment and management — the

complexities of clinical practice. J Clin Nurs. 2002;11:724-733.

19.Schumacher K, West C, Dodd M, Paul S, Tripathy D, Koo P, Miaskowski C. Pain management

autobiographies and reluctance to use opioids for cancer pain management. Cancer Nurs. 2002;25(2):125-133.

20.Ward S, Goldberg N, Miller-McCauley V, Mueller C, Nolan A, Pawlik-Plank D, Robbins A,

Stormoen D, Weissman D. Patient-related barriers to management of cancer pain. Pain. 52: 319- 324.

21.Kemper J. Pain management of older adults after discharge from outpatient surgery. Pain Manage Nurs. 2002;3(4):141-153.

22.Closs S, Briggs M. Patients’ verbal descriptions of pain and discomfort following orthopaedic surgery. Int J Nurs Stud. 2002;39:563-72.

23. Oliver J, Kravitz R, Kaplan S, Meyers F. Individualized patient education and coaching to

improve pain control among cancer outpatients. J Clin Oncol. 2001;19:2206-2212.

24.Miaskowski C, Dodd M, West C, Schumacher K, Paul S, Tripathy D, Koo P. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol. 2004;22:1713-1720.

25.White M, Bonvicini K. Bayer Institute for Health Care Communication annotated

bibliography for clinician patient communication to enhance health outcomes, accessed 1/26/05, http://www.bayerinstitute.org/pdfs/biblio/ CPC %20Bibliography-2-10-2005.doc; 2003.

26.Beckman H, Frankel R. The effect of physician behavior on the collection of data. Ann Intern Med. 1984;101:692-696.

27. Marvel M, Epstein R, Flowers K, Beckman H. Soliciting the patient's agenda have we improved? JAMA. 1999;281:283-287.

28.Roter D, Hall J, Kern D, Barker L, Cole K, Roca R. Improving physicians’ interviewing skills and

reducing patients’ emotional distress. Arch Intern Med. 1995;155:1877-1884. 29.Roter D, Hall J, Aoki Y. Physician gender effects in medical communication a meta-

analytic review. JAMA. 2002;288:756-764. 30. Street R. Information-giving in medical consultations: the influence of patients’ communicative

styles and personal characteristics, Soc Sci Med. 1991;32:541-548. 31.Street R. Communicative styles and adaptations in physician-parent consultations. Soc Sci Med.

1992:34:1155-1163. 32.Hall, J, Roter D. Do patients talk differently to male and female physicians? A meta-

analytic review. Patient Educ Couns. 2002;48:21 7-224. 33.Cegala D, Post D, McClure L. The effects of patient communication skills training on the

discourse of older patients during a primary care interview. JAGS. 2001;49:1505-1511.

34. Thompson S, Nanni C, Schwankovsky L. Patient-oriented interventions to improve communication

in a medical office visit. Health Psychol. 1990;9:390-404. 35.Anderson L, DeVellis B, DeVellis R. Effects of modeling on patient communication

satisfaction and knowledge. Med Care. 1987;25:1044-1056. 36.Robinson E, Whitefield M. Improving the efficiency of patients’ comprehension monitoring: a

way of increasing patients’ participation in general practice consultations. Soc Sci Med.

1985;21:915-919. 37. Tran A, Haidet P, Street R, O’Malley K, Martin F, Ashton C. Empowering communication: a

community-based intervention for patients. Patient Educ Couns. 2004;52:113-121.

38.Kaplan S, Greenfield S, Ware J. Assessing the effects of physician-patient interactions

on the outcomes of chronic disease. Med Care. 1989;27:S110 — S127.

PHS 398/2590 (Rev. 09/04) Page 35 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

462 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

39. Giamberardino M. (Ed.). Pain 2002 — an updated review refresher course syllabus 1 0" world congress on pain. Seattle, WA: International Association for the Study of Pain; 2002.

40. Turner G, Weiner D. Essential components of a medical student curriculum on chronic pain management in older adults: Results of a modified Delphi process. Pain Med. 2002;3:240-

2522 41.Roter D, Larson S, Shnitzky H, Chernoff R, Serwint J, Adamo G, Wissow L. Use of an innovative

video feedback technique to enhance communication skills training. Med Educ. 2004;38: 145-157. 42.Moral R, Alamo M, Jurado M, Torres L. Effectiveness of a learner-centered training programme for

primary care physicians in using a patient-centered consultation style. Fam Pract. 2001;18:60-63. 43.Ryan E, Hamilton J, See S. Patronizing the old: How do younger and older adults respond to baby

talk in the nursing home? Int J Aging Hum Dev. 1994;39:21-32. 44. Fox S, Giles H. Accommodating intergenerational contact: A critique and theoretical

model. J Aging Stud. 1993:7:423-451. 45.Giles H. Accent mobility. A model and some data. Anthro Ling. 1973;15:87-105. 46.Coupland N, Coupland J, Giles H, Henwood K. Accommodating the elderly: Invoking

and extending a theory. Lang Soc. 1988;17:1-41. Lawrence Erlbaum Associates Inc; 1988.

47. McDonald D. Gender and ethnic stereotyping and narcotic analgesic administration. Res Nurs

Health. 1994;17:45-49. 48. McDonald D. Nurses' memory of patient's pain. Int J Nurs Stud. 1996;23:487-494. 49.McDonald D, Sterling R. Acute pain reduction strategies used by well older adults. Int J Nurs

Stud.1998;35:265-70. 50. McDonald D. Postoperative pain after hospital discharge. Clin Nurs Res. 1999;8: 347-359. 51.McDonald D Weiskopf C. Adult patients’ postoperative pain descriptions and responses to

the Short-Form McGill Pain Questionnaire. Clin Nurs Res. 2001;10:442-452.

52. McDonald D, Freeland M, Thomas G, Moore J. Testing a preoperative pain management intervention for older adults. Res Nurs Health. 2001;24:402-409.

53.McDonald D, Molony S. Postoperative pain communication skills for older adults. Wes J Nurs Res. 2004;26:836-852.

54.McDonald D, Thomas G, Livingston K, Severson J. Assisting older adults to communicate their pain after surgery. Clin Nurs Res. 2005;14:109-126.

55. Cohen J. Statistical Power analysis for the Behavioral Sciences, 2™ ed., Hillsdale, NJ: Lawrence

Erlbaum Associates, Inc; 1988.

56. Stevens J. Applied Multivariate Statistics for the Social Sciences. Mahwah, New Jersey: Lawrence Erlbaum Associates, Inc; 1996.

57.National Institutes of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Handout on health: Osteoarthritis. 2005. Accessed, 4/21/05,

http://www.niams.nih.gov/hi/topics/arthritis/oahandout.htm.

58.Sharma L. Epidemiology of osteoarthritis. In Moskowitz R, Howell O, Altman R, Buckwalter J, V Goldberg eds. Osteoarthritis: Diagnosis and Medical-surgical Management (3 ed., pp. 3-17). Philadelphia: Saunders; 2001.

59. Resnick B, Inguito P, Yahiro J, Hawkes W, Werner M, Zimmerman S, Magaziner J. Treatment fidelity in behavior change research: A case example. Nurs Res. 2005;54:139-143.

60.Roter D. Observations on methodological and measurement challenges in the assessment of communication during medical exchanges. Patient Educ Couns. 2003;50:17-21.

61.Arthritis Foundation. Managing your Pain. Atlanta, GA: Arthritis Foundation, Inc; 2003.

62.Daut R, Cleeland C, Flanery R. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983:17:197-210.

63.Zalon M. Comparison of pain measures in surgical patients. J Nurs Meas. 1999:7:135-152.

PHS 398/2590 (Rev. 09/04) Page 36 ae Continuation Format Page

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 463

Principal Investigator/Program Director (Last, First, Middle): McDonald, Deborah Dillon

64. Krippendorff K. Content Analysis an Introduction to Its Methodology. 2"° ed. Thousand Oaks, CA: Sage Publications; 2004.

65.Huberty, C. Applied discriminant analysis. New York: Wiley; 1994. 66.U.S. Census Bureau. Profile of general demographic characteristics: 2000 data set: Census 2000

summary file1 (SF 1) 100-percent data geographic area: Bridgeport city, Connecticut, accessed 4/5/05, http://factfinder.census.gov/servlet/SAFFFacts? event=ChangeGeoContext

&geo_ id=16000US0908000&_geoContext=&_street=&_county=Bridgeport&_cityTown= Bridgeport&_ state=04000US09&_zip=&_lang=en&_sse=on&ActiveGeoDiv=&_useEV= &pctxt=fph&pgsl=010.

67.U.S. Census Bureau. Profile of general demographic characteristics: 2000 data set: Census 2000 summary file1 (SF 1) 100-percent data geographic area: New Haven city, Connecticut, accessed 4/5/05, http://factfinder.census.gov/serviet/SAFFFacts?_event=ChangeGeo

Context&geo_id=16000US0952000& geoContext=& street=& county=New+Haven&

cityTown=New+Haven & _state=04000US09& zip=& lang=en& sse=on&ActiveGeoDiv=&

useEV=& pctxt=fph&pgsl=010

H. Consortium/Contractual Arrangements

N/A

1. Resource Sharing

N/A

J. Consultants

Leonard Katz, PhD, Consultant (Y2-1%) will advise the PI regarding statistical analyses.

Joel Rosiene, PhD, Consultant (Y1-5%) will program the SuperLab software and the videos onto the

study laptop computer. He will test the software to randomize participants to condition, and present

the videos.

Letters Confirming Role in the Project

Leonard Katz

Joel Rosiene

Letters of Commitment from Sites

P.C. Smith Towers and Betty Knox Apartments

Capitol Towers Harborview Towers

Park Ridge i & Il Fireside Apartments

Tower One/Tower East

PHS 398/2590 (Rev. 09/04) Page 37 Continuation Format Page

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

464 APPENDIXN «® Health Care Practitioner Pain Communication: R21 Grant Application

SUMMARY STATEMENT ALEXIS BAKOS ( Privileged Communication ) Release Date: 11/03/2005

301.594.2542 [email protected]

Application Number: 1 R21 NR009848-01

MCDONALD, DEBORAH D PHD UNIVERSITY OF CONNECTICUT SCHOOL OF NURSING 231 GLENBROOK ROAD, UNIT 2026 STORRS, CT 06269-2026

Review Group: NSAA Nursing Science: Adults and Older Adults Study Section

Meeting Date: 10/13/2005 RFA/PA: PA03-152 Council: JAN 2006 PCC: GXXAB

Requested Start: 05/01/2006 Dual IC(s): AG

Project Title: Older Adults' Response to Health Care Practitioner Pain Communication

SRG Action: Priority Score: 167

Human Subjects: 44-Human subjects involved - SRG concerns Animal Subjects: 10-No live vertebrate animals involved for competing appl.

Gender: 1A-Both genders, scientifically acceptable Minority: 1A-Minorities and non-minorities, scientifically acceptable

Children: 3A-No children included, scientifically acceptable

Clinical Research - not NIH-defined Phase III Trial

Project Direct Costs Estimated Year Requested Total Cost

1 100,000 148,000 2 75,000 111,000

TOTAL 175,000 259,000

ADMINISTRATIVE BUDGET NOTE: The budget shown is the requested budget and has not been

adjusted to reflect any recommendations made by reviewers. If an award is planned, the costs will be calculated by Institute grants management staff based on the recommendations outlined below in the COMMITTEE BUDGET RECOMMENDATIONS section.

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 465

NSAA 2 1 R21 NROO9848-01 MCDONALD, D

1R21NR009848-01 MCDONALD, DEBORAH

PROTECTION OF HUMAN SUBJECTS UNACCEPTABLE

RESUME AND SUMMARY OF DISCUSSION: The goal of this application is to identify practitioner pain communication strategies that allow patients to describe pain information important for guiding effective pain management and to substantiate what pain information is missed when practitioners use less

effective pain communication. This is a very interesting new application form an experienced young investigator using a posttest-only double blind experiment to test type of provider communication on audio taped patient responses. The methods are highly innovative and the application is significant.

The design and methods are creative and innovative and the analyses are appropriate to the aims of

the project. There may be some introduced bias from the pre-intervention use of the BPI. And, the study protocol could be better presented. The previous work and commitment of this investigator to

studying communication about pain and the well-prepared research team and strong environment bode well for the application.

DESCRIPTION (provided by applicant): How practitioners communicate with patients about their pain

has been overlooked as a factor contributing to effective pain management. Eliciting important pain information from patients enables practitioners to prescribe more specific pain treatments, and

significantly decrease pain. The aim of our study is to test the effect of practitioners asking patients an

open-ended question about pain that does not encourage a socially desirable response. A posttest only double blind experiment will test how the phrasing of health care practitioners’ pain questions, open-

ended and without social desirability bias; closed-ended and without social desirability bias; or open-

ended and with social desirability bias, affects the pain information provided by people with chronic

pain. Three hundred community dwelling older adults with chronic osteoarthritis pain will be randomly

assigned to one of the three practitioner pain communication conditions. Older adults will watch and verbally respond to a videotape clip of a practitioner asking the patient about their pain. The clips will be

identical except for the pain question asked by the practitioner. After responding to the pain question, all of the older adults will respond to a second videotape clip of the practitioner asking if there is

anything further they want to communicate. The older adults will then respond to a third videotape clip

asking if there is anything further they want to communicate about their pain. Responses to the three videotape clips will be audiotaped. To control for pain differences between participants, the Brief Pain

Inventory Short Form will be administered to measure present pain intensity and pain interference with

functional activities. Participants’ audiotaped responses will be transcribed and content analyzed using

a priori criteria from national guidelines to identify communicated pain information and omitted pain

information important for osteoarthritis pain management. The three groups will be compared for the communicated pain information and omitted pain information while controlling for present pain intensity

and pain interference with activities. The goal is to identify practitioner pain communication strategies

that allow patients to describe pain information important for guiding effective pain management, and to

substantiate what pain information is missed when practitioners use less effective pain communication. The results will provide empirically tested communication strategies that can be used in practitioner and

patient pain communication education.

CRITIQUE 1:

Significance: Pain communication between patient and practitioner are crucial if the patientis pain is to

be adequately treated. This is particularly the case with conditions characterized by chronic pain such

as osteoarthritis. Prior research has indicated that pain control is a problem for patients receiving acute

care and for patients with chronic conditions characterized by pain who dwell in the community. This

research will test communication strategies that can enhance patient and practitioner communication

about pain, which could result in better pain control.

Approach: The aim of the study is straightforward, clear and testable. The importance of clear

communication to pain control was highlighted in the background and significance section and prior

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

466 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

NSAA 3 1 R21 NROO9848-01 MCDONALD, D

research evidence supports this view. The principal investigator referenced nine studies focused on communication about pain between providers and patients in the preliminary studies section. A post-

test only double blind experiment will be used for this study to'test how the phrasing of health care practitionersi pain question (open-ended without social desirability, closed-ended without social

desirability, or open-ended with social desirability bias) affects the pain information provided by older adults with chronic osteoarthritis pain. Power analysis supports the projected sample size of 300. The random assignment of subjects to the three conditions that will be assessed is a strength of the study as well as keeping the persons who wiil do the content analysis of data blind to the condition to which

each subject will be responding. Use of video taped provider communication scenarios has the

advantage of standardizing provider communication to which the subjects would respond. Audio taping

of the participantis responses also will ensure that responses are more accurately captured for later

analysis. The second part of each practitioner video as described will ask two open-ended questions fi

one more general and one focused on encouraging discussion about pain. This will allow all subjects to ultimately respond to open-ended without social desirability questions. However, this aspect of the intervention is not fully acknowledged in the discussion of the design and the data analysis.

Randomization of the administration of the Brief Pain Inventory Short Form for administration prior to or

after the presentation of the videos should control for learning effects. Reliability and validity information

for the Brief Pain Inventory Short Form was given. The debriefing session should adequately allow for handling of hypothesis guessing and any distress about deception regarding the focus of the study because of the use of a cover story. The content analysis procedure described follows accepted

standards. Use of the American Pain Society's "Guidelines for the Management of Pain in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Chronic Arthritis" for coding data will also help to yield a more reliable content analysis process. The approaches to data analysis are detailed and appropriate

the address the research hypothesis. Redundancy and some disorganization of content in the design section was sometimes confusing.

Innovation: Patient and provider communication about pain has been a research concern in health

care for many years. The uniqueness of this study lies in its focus on assessing specific communication approaches with older persons suffering with chronic pain in the community. The use of videotaped

scenarios to which subjects will respond about their pain is a rather unique methodological approach for collecting this type of data.

Investigators: The principal investigator has a track record of publications focused on pain

assessment and communicating pain. She has prior NIH funding for a project focused on post-

operative pain. She will collaborate with a psychologist who will assist with statistical analysis and with

a computer consultant. The research team has the experience to successfully complete the proposed project.

Environment: The University of Connecticut has the research resources to support this project.

Participants will be recruited from seven independent living elder housing sites throughout Connecticut. Letters of support are included from the seven sites. The Seven Seas Film Company will produce the three videotapes required for the study.

Overall Evaluation: The proposed study addresses an important area in health care — control of chronic pain in older adults with chronic conditions. The focus on communication about pain could be a cost-effective approach for helping to address this problem if specific communication strategies are found to aid pain control. The proposed study has many strengths including a straightforward and clearly explicated aim, a background section and preliminary studies supportive of the proposed study, a well designed experimental approach, a well operationalized independent variable, a carefully planned data collection protocol, appropriate content analysis procedures, and detailed plans for Statistical analysis which should address the study hypothesis. The description of the study protocol was sometimes confusing due to repetitive content that could have been better organized. This is a relative minor limitation given the many strengths of the proposal.

APPENDIXN Health Care Practitioner Pain Communication: R21 Grant Application 467

NSAA 4 1 R21 NRO09848-01 MCDONALD, D

Protection of Human Subjects from Research Risks: This study will require the participation of 300 community dwelling older adults with osteoarthritis pain who are age 60 and older. Recruitment Strategies are described. Procedures for obtaining informed consent and protection against risks are generally adequate. However, participant responses will be audio taped for later analysis. No mention was made if or how these audio tapes would be destroyed after they are analyzed. If they are to be retained for any purpose, permission must be obtained from participants. Potential benefits to subjects and others and the knowledge to be gained also are adequate.

Inclusion of Women Plan: Both women and men will be included in the sample. It is expected that 207 (69%) of the 300 subjects will be women.

Inclusion of Minorities Plan: It is anticipated that 12% of the sample will be Hispanic, 16% African American, and 8% from other minority groups.

Inclusion of Children Plan: Participants will be 60 years of age or older. Older adults have been targeted for the study because they typically have more difficulty communicating their pain than younger persons.

Budget: The budget is justified and appropriate.

CRITIQUE 2:

Significance: This R21 application addresses the problem of inadequate pain communication between patients and health care practitioners that could result in undiagnosed pain due to omission of important information for treatment of pain. If the aims of the application are achieved, practitioners can be taught

to use open-ended pain assessment questions such as "tell me about your pain" and not ask: "How are

you feeling?" which has social desirability implications. The aims are to determine which communication strategies encourage older adults to describe important information and what information is missed with ineffective communication strategies.

Approach: The review of literature is integrated and organized and the argument for the study is well

developed and logical. The Communication Theory Attuning Strategies is described, but more clarity is needed so that concepts of the research are linked to or explained by concepts of the theory. The

posttest-only double blind experiment is strong with some ingenious video and software methods

planned for randomization to groups and for providing the experimental videotape clips. Blindness of

the graduate assistant to computerized random assignment and the method of starting the video after

leaving the room are strengths of the innovative methodology.

The previous experience of the PI is varied but fairly strong with 9 studies of practitioner and patient

communication that the PI claims prepared the team to conduct randomized controlled trials with older

adults, develop standardized intervention videos, and to learn content analysis of participants’ responses. Although the findings of the 9 studies are listed, they have not been tied together into a

narrative that shows substantive support for conducting this study.

The posttest-only double blind design is strong but a flaw seems to be that half the sample will be randomly assigned to answer the Brief Pain Inventory (BPI) before the experimental test. In doing this they will answer 16 pain assessment questions that could strongly bias the amount of information given

in response to the video. Even with randomization of the BPI sequence, it seems that the purpose of

the study would be compromised. The investigators do not expect a timing effect (interaction) but

responding to the BPI before the test would raise participant awareness of the DV, "important

information” when subsequently answering the video questions. Since it seems less likely that they

would respond differently to the BPI after the videos and since the BP! is not the major DV, why not

simply administer the BPI after the video test for all participants to eliminate the threat introduced by

counterbalancing? In addition there is inconsistency in the several reasons given for counterbalancing

with permission. Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

468 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

NSAA 5 1 R21 NROO9848-01 MCDONALD, D

the assessment of pain intensity and interference with the BPI. These include: to control for present pain differences, for timing of the BPI, for timing differences, for the measurement effect, for the learning effect. On the other hand, counterbalancing would give some exploratory information. The

threats to internal validity need to be carefully and consistently identified and minimized

The a prior osteoarthritis pain management criteria from the American Pain Society guidelines need further specification for use in this study. For example, the nociceptive/neuropathic type of pain needs to be operationally defined in terms of what kinds of participant responses will be categorized as each type. Direct questioning by a knowledgeable nurse might more accurately assess that differentiation. In

addition, it is not clear what is included in the criterion, current pain treatments.

In general, the analysis procedures seem to answer the research question. However, the multivariate factor is not clear. It seems to be composed of the sum of "important information included" and the sum

of "important information exciuded," which intuitively may be two sides of the same coin.

Innovation: The study is innovative because it tests patients' responses to different ways of that health

care personnel might ask about their pain. There are several very innovative features surrounding the

video taped treatment, and the technological methods to randomly assign and maintain blindness.

Investigators: Dr. McDonald is an Associate Professor at the University of Connecticut and holds bachelors and masters degrees in Nursing. Her PhD is in Social Psychology from Columbia University in 1990. She received a pre-doctoral fellowship from the National Center for Nursing Research from

1988 —1990, but does not list the topic, so it is not clear whether the results were published. She also

received an R15 award from NINR, 1999 — 2001, and has published the results. She has received two other grants, one from the Donaghu Foundation and one from the University of Athens in Greece with publications. She lists 14 publications that appear to be data based. Dr. Katz is a Professor at the University of Connecticut and has his PhD in Psychology from University of Massachusetts/Amherst. He is a consulting statistician at Mount Sinai Medical School in New York and will consult in Year 2 of

this project regarding statistical analyses. Joel Rosiene is an Associate Professor of Computer Science at Eastern Connecticut State University. He will program the laptop computer with the software and

insert the healthcare practitioner videotape clips as the experimental manipulation. The research team is well qualified to conduct this study.

Environment: The environment includes seven independent living elder housing sites in Connecticut that will ensure an adequate sample. The study will be conducted in the living quarters of the residents.

There is support from University of Connecticut in terms of computer resources, personnel and offices

in the school of nursing. As in a previous study, the Pi will work with the Seven Seas Film Company to produce videotapes needed for the study. Support is good for the accomplishment of the aims.

Overall Evaluation: This is a very interesting new application form an experienced young investigator using a posttest-only double blind experiment to test type of provider communication on audio taped

patient responses. The methods are highly innovative and the study is very significant. The design

and methods are creative and innovative and the analyses are generally appropriate to the aims of the

project. The major strengths of the application are the innovative methods for blindness, randomization,

and reliability of the intervention; the previous work and commitment of this investigator to studying communication about pain, the well-prepared research team and strong environment. Potential bias from the pre-intervention use of the BPI, lack of operational definitions of the coding criteria, and some inconsistencies are noted. There are some human subjects issues but inclusion of participants is adequate with respect to gender, minority group status and children.

Protection of Human Subjects from Research Risks: The application adequately addresses risks, protection against risks, benefits and importance of the knowledge to be gained. Debriefing the participants is thoughtfully planned, but it seems inappropriate to remind them at the end of the study that if they have distress or concern about the study, they are free to withdraw. Another comment is that

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 469

NSAA 6 1 R21 NRO09848-01 MCDONALD, D

the method of contacting the participants is not clear. This is a clinical trial but a data safety monitoring plan is not adequately presented.

Inclusion of Women Plan: The research involves 31% men and 69% women, although rationale was not given.

Inclusion of Minorities Plan: The research involves minorities and non-minorities: 76% white, 16%

black, 12% Hispanic, 4% Asian, 2% Native Hawaiian or Other Pacific Islander, and 2% American Indian/Alaskan Native. Recruitment from nearby cities that contain 20% to 30% people of color will increase the ethnic and racial representation of the sample.

Inclusion of Children Plan: The research involves only/adults because osteoarthritis is a painful

condition associated with aging and older adults are more vulnerable to problems communicating about their pain. The age range of the sample is 60 and older.

Budget: The requested budget is appropriate for the work.

CRITIQUE 3:

This is a proposal by a new investigator that proposes a novel approach to improving communication

between older adults and their health care providers about pain. The design is a post-test only double- blind experiment to test how phrasing of health care practitioners’ pain questions affect pain information

provided by older adults with chronic osteoarthritis pain. The investigator makes the case for better communication skills on the part of providers. Recent renewed interest by the scientific community and foundations in the effectiveness of provider communication skills, including listening and questioning, in

improving health care delivery provides support for a study of this nature. The failure of health care providers to adequately listen to patient's complaints of pain, coupled with known reluctance to

adequately treat pain, high light the significance of this study topic. Study outcomes would have

immediate application in provider and patient pain communication education. The investigator has

experience [including an R15] in studying various aspects of pain and pain communication in a variety of populations. Further, she has amassed a group of collaborators that complement her own skills,

including ideography, computerized randomization and experimental manipulation of video clip testing.

Adequate resources are described, including agreement from a sufficient number of senior housing units to assure adequate sample size. On page 24 the investigator introduces for the first time the

notion of (apriori criteria) for coding the qualitative data and these need more description and clarification; presumably they relate to the American Pain Society Guidelines which appear later. The

study design is well developed and described with appropriate rationale for decisions. The need for use

of mild deception is adequately addressed in the human subjects section and subjects will be debriefed.

There are minimal risks.

THE FOLLOWING RESUME SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW ADMINISTRATOR TO SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE ON THE FOLLOWING ISSUES:

PROTECTION OF HUMAN SUBJECTS (Resume): UNACCEPTABLE. The reviewers noted human

subjects concerns because information provided on the Data and Safety Monitoring Plan is insufficient.

INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE. The reviewers concluded that the

degree of inclusion of women is appropriate.

INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE. The reviewers concluded that the

inclusion of minorities is appropriate.

with permission. Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

470 APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application

NSAA 7 1 R21 NROO9848-01 MCDONALD, D

INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE. The reviewers concluded that the exclusion of children is appropriate.

COMMITTEE BUDGET RECOMMENDATIONS: The reviewers recommended no changes in the

budget.

NOTICE: The NIH has modified its policy regarding the receipt of amended applications. Detailed information can be found by accessing the following URL address: http://grants.nih.gov/grants/policy/amendedapps.htm

NIH announced implementation of Modular Research Grants in the December 18, 1998 issue of the NIH Guide to Grants and Contracts. The main feature of this concept is that grant applications (R01, RO3, R21, R15) will request direct costs in $25,000 modules, without

budget detail for individual categories. Further information can be obtained from the Modular Grants Web site at http://grants.nih.gov/grants/funding/modular/modular.htm

APPENDIXN ® Health Care Practitioner Pain Communication: R21 Grant Application 471

Deborah Dillon McDonald

Associate Professor

(O) 860-486-3714

(Email) [email protected] 12/16/2005

Alexis D. Bakos, PhD, MPH, RN,C Program Director Office of Extramural Programs

National Institute of Nursing Research National Institutes of Health Bethesda, MD 20892-4870

Dear Dr. Bakos,

Thank you for the opportunity to respond to reviewer comments regarding human subjects protection for our grant application 1R21NR008948-01, Older Adults’ Response to Health Care

Practitioner Pain Communication. The PI will keep the data for five years after completion of data

analysis, at which time the PI will destroy the audiotapes and shred hard copies of the raw data. Older adults’ permission to maintain the secured raw data will be requested in the consent form, and as part

of the consent process. Participants will be fully informed about the study during the debriefing. We will

remind participants of their option to withdraw from the study, giving them the opportunity to deny inclusion of their data once they are fully informed. We have included our Data and Safety Monitoring Plan below. Thank you for your valuable support and feedback.

Data and Safety Monitoring Plan Data and safety monitoring will be described for the older adults and the data, which include the

audiotape response, the transcripts; and written response to the BPI-SF and demographic form. The Pl

will be responsible for monitoring data and safety. The data will be kept secure in a locked file cabinet in the Pl’s private university office. Data entered into the computer for data analysis will be kept on the

Pl’s private office computer with password protection. The professional transcriptionist will transcribe

the anonymous audiotapes, and maintain confidentiality of the information. The Pl and GA will maintain

confidentiality of the audiotape and written data.

Adverse events are unlikely. The GA will be trained to detect adverse events such as distress

about pain by gently probing for concerns and distress during the debriefing. The previously identified

protocol for referring to a health care practitioner will be used if the GA identifies any older adult with a

pain referral need. The GA will enter into an adverse events reporting log the participant identification

number, a description of the adverse event, and the action taken to resolve the adverse event. The PI

will immediately report adverse events to the University of Connecticut IRB.

The PI will keep the data for five years after completion of data analysis, at which time the PI will

destroy the audiotapes and shred hard copies of the raw data. Older adults’ permission to maintain the secured raw data will be requested in the consent form, and as part of the consent process. An annual

report of the Study will be made to the National Institute of Nursing Research and University of

Connecticut IRB including a report of the data and safety monitoring.

Sincerely,

Deborah Dillon McDonald, RN, PhD

Principal Investigator

Carol Welt, Ph.D. Executive Director & Assistant Vice Provost for Research

with permission. Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

Mutti-Omics ANALYSIS:

RO1 GRANT APPLICATION Xiaomei Cong

- APPENDIXO ® Multi-Omics Analysis: R01 Grant Application 473

@ Publicly Available Information

The following information is publicly available through the NIH RePORTER.

Research Portfolio Online Reporting Tools Search inte (RePORT)

HOME | ABOUT RePORT | FAQs | GLOSSARY | CONTACT US

QUICK LINKS RESEARCH ORGANIZATIONS WORKFORCE FUNDING REPORTS LINKS & DATA

Home > RePORTER > Project Information RePORTER Login] Registor} RePORTER Manual — System Hoalth: |] GREEN

Project Information SRE) (Geis 1RO1NRO16928-01A1

PI PROFILE LINKS A MORE INFOD

Project Number: 1RO1NRO16928-01A1 Contact Pl / Project Loader; CONG. XIAOME! SOPHIA

Titlo: MULTI-OMICS ANALYSIS OF PAIN/STRESS IMPACT ON NEURODEVELOPMENT Awardoo Organization: UNIVERSITY OF CONNECTICUT STORRS IN PRETERM INFANTS

DESCRIPTION DETAILS. RESULTS HISTORY SUBPROJECTS SIMILARPROJECTS NEARBY PROJECTS 8£TA Links @ NEWS AND MORE &

Contact PI / Project Leader Information: 44 Program Official Information: Other P! Information: & Profile Exists £4 No Profile

Name: CONG, X!AOMEI SOPHIA (5 Name: TULLY, LOIS Not Applicable

Email: Click to view Contact PI / Project Leader Email: Click to view PO email address

email address

Title: PHD, RN, FAAN

Organization: Department Type/ Organization Type: Congressional District:

Name: UNIVERSITY OF CONNECTICUT STORRS NONE State Code: CT

City: STORRS-MANSFIELO Country: UNITED STATES (US) SCHOOLS OF NURSING District: 02

Other Information:

FOA: PA-16-160 DUNS Number: 614209054 CFDA Code: 361

Study Section: Nursing and Related Clinical Sciences Study Section Project Start Date: 14-SEP-2017 Project End Date: 31-JUL-2021

(NRCS) Budget Start Date: 14-SEP-2017 Budget End Date: 31-JUL-2018

Fiscal Year: 2017 Award Notice Date: 13-SEP-2017

Administering Institutes or Centers:

NATIONAL INSTITUTE OF NURSING RESEARCH

Project Funding Information for 2017:

Total Funding: $657,200 Direct Costs: $459,571 Indirect Costs: $197,629

Year Funding IC FY Total CostbyIC

2017 NATIONAL INSTITUTE OF NURSING RESEARCH $657,200

Categorical Spending by IC: ~- Click here for more information on NIH Categorical Spending

with permission. Generating and Assessing Evidence for Nursing Practice (11th ed.)

474 APPENDIXO #

Research Portfolio Online Reporting Tools

(RePORT)

Multi-Omics Analysis: R01 Grant Application

Search _ es cee IX

HOME | ABOUT RePORT | FAQs | GLOSSARY | CONTACT US

QUICK LINKS RESEARCH ORGANIZATIONS WORKFORCE FUNDING REPORTS LINKS & DATA

Kome > RePORTER > Project Information

Project Information 1RO1NRO16928-01A1

RePORTE R Login| Register] RePORTER Manual System Hesith: 1) GREEN

“Back to Query Form | [ Print Version |

Retetiatet hl DETAILS RESULTS HISTORY SUBPROJECTS SIMILARPROJECTS NEARBY PROJECTS BETA iinks @ NEWS AND MORE

Project Number: 4RO1NRO16928-01A4

Title: MULTI-OMICS ANALYSIS OF PAIN/STRESS IMPACT ON NEURODEVELOPMENT Awardee Organization: IN PRETERM INFANTS

Abstract Text:

Contact PI/ Project Loader: CONG, XIAOME! SOPHIA | UNIVERSITY OF CONNECTICUT STORRS |

PROJECT SUMMARY Despite substantial gains in survival of preterm infants, concerns remain regarding the significant neurological morbidity and long-term adverse outcomes

related to insults on the immature Immune and brain-gut-microbiota systems affected by painful/stressful early life experience during the neonatal intensive care (NICU) stay. Our

preliminary K23 results show that cumulative pain/stress events are significantly associated with higher abundance of gut Enterobacteria (Phylum: Proteobacteria), a

characteristic pattern of dysbiosis, which may contribute to neurodevelopmental deficits during the NICU stay. In light of these results, the primary hypothesis driving this research

is that cumulative pain/stress experienced in early life combined with gut dysbiosis and specific genetic susceptibilities increase the risk of neurodevelopmental morbidity in

preterm infants during infancy and early childhood. A prospective longitudinal design will be used to examine: 1) the impact of cumulative pain/stress events in the NICU along

with gut microbiome development on infant neurodevelopmental outcomes over the short- (NICU stay) and long-term (follow-up); 2) interaction effects of host genetics, gut

microbiome, and early life pain/stress events on infant neurodevelopmental outcomes, while controlling for sex, feeding and other environmental factors over time; and 3) the

impact of different levels of pain/stress experiences on the gut microbiome and neurodevelopment outcomes as well as other growth parameters using twin- pairs. The proposed

4-year project will recruit and follow 200 preterm infants (160 infants in the final analysis considering the attrition) during NICU hospitalization and until 18-24 months corrected

age (CA). Primary measures in the NICU Include dally pain/stress events (NICU Infant Stressor Scale), gut microbiome patterns and function (stool sample: twice/week; 16S

rRNA gene and metagenomic sequencing), host genetics (whole exome sequencing to identify genetic variants that effect neuro-gut-immune signaling), autonomic responses

(weekly; heart rate variability) and neurodevelopmental outcomes (at 36 weeks CA; NICU Network Neurobehavioral Scale). At follow-up visits, gut microbiome,

neurodevelopmental outcomes, including pain sensitivity will be measured at 4, 6-12, and 18-24 months CA

Public Health Relevance Statement:

PROJECT NARRATIVE Neurodevelopmental deficits associated with preterm birth cost the United States over 26 billion annually and include hidden burdens for families.

Cumulative stress and painful events have been shown to alter neuro-gutimmune signaling in preterm infants cared for in the neonatal intensive care (NICU), however, the

precise mechanisms by which these events impact neurodevelopmental outcomes remains unclear. The proposed research aims to use multi-omic approaches to elucidate the

specific causal pathways between pain/stress events, neuro-gut- immune signaling, genetic variation and neurodevelopmental outcomes over time in order to improve preterm

infant health, decrease costs, and reduce burdens to preterm infants’ families and society.

NIH Spending Category:

Basic Behavioral and Social Science; Behavioral and Social Science; Clinical Research; Genetics; Health Disparities; Mental Health; Minority Health; Neurosciences; Pain

Conditions - Chronic; Pain Research; Pediatric; Perinatal Period - Conditions Originating in Perinatal Period; Preterm, Low Birth Weight and Health of the Newborn; Prevention

Project Terms:

adverse outcome; Affect; Age; Architecture; Automobile Driving; base; biological adaptation to stress; Brain; Characteristics; cognitive function; cost; Data; Development;

Dizygotic Twins; early childhood; Enterobacteriaceae; Environmenta! Risk Factor; Event; exome sequencing: experience; Family: Feces; feeding; follow-up; Genetic; Genetic

Predisposition to Disease; genetic variant; Genetic Variation; Growth; gut microblome; gut microbiota; Health; Health behavior, Health Care Costs; heart rate variability; high risk

infant; Hospitalization; Human; Immune; Immune signaling; improved; infancy; Infant; Infant Care; Infant Health; Intervention; Knowedge; Lead; Life: Life Experience; Light:

longitudinal design; Measures; Mental Health, metagenomic sequencing; Microbe; microbial community; microbial genome; microbial host; microbiome; Monozygotic twins;

Morbidity - disease rate; Neonatal; Neonatal Intensive Care; Neonatal Intensive Care Units; neurobehavioral; neurodevelopment; Neurodevelopmental Deficit; Neurologic;

Outcome; Pain; pathogen; Pathway interactions; Pattern; personalized intervention; premature; Premature Birth; Premature Infant; prospective; Proteobacteria; Recruitment

Activity; Research; research study; response; Risk; rRNA Genes; Sampling; Sampling Studies; Self-control as a personality trait; sex; Societies; Syess; Survivors; System;

Testing; Time; trait; Twin Multiple Birth; United States; Visit

# Specific Aims

Even with advances in neonatal intensive care

and substantial increases in survival among

preterm infants, neurobehavioral morbidity

related to neonatal insults remains to be a significant concern, e.g., 40% of neonatal intensive care unit (NICU) survivors have at

least one neurodevelopmental deficit6 with

related costs being > $26 billion per year plus added hidden burdens for families. Through

Generating and Assessing Evidence for Nursing Practice (11th ed.)

our K23 study, we found that cumulative pain/

stress experiences in early life are significantly

related to altered neurobehavioral outcomes in preterm infants cared for in the NICU.

However, the precise mechanisms underlying the impact of pain/stress experience on neuro- development in this dynamic and vulnerable window remain largely unknown. Intriguingly,

the gut microbiome, neuro-gut-immune sig-

naling and interactions with host genetics have recently been shown to impact both short and long-term neurobehavioral health.

Reprinted

with permission.

- APPENDIXO

In order to reduce costly health consequences

from prematurity and identify neuro-protective strategies that can be integrated into routine

preterm infant care, the exact mechanisms by which early life pain/stress alter neurodevelop- mental outcomes must be understood.

The gut microbiome influences many significant aspects of human health and behavior, such as cognitive function, mental

health, and pain/stress responses through the

brain-gut-microbiota axis. Gut microbes, together with the host, constitute the holo- biont (the combination of a host and its

microbial communities that together pro- vide the host with its capabilities). Recent research shows that the human host genetic

architecture is involved in determining the gut

microbiome. However, the identification of

the preterm infant host genetic predisposition for specific gut microbiome patterns and func- tions has not been studied. In order to begin the development of personalized interventions

for vulnerable high-risk infants, research that deciphers the impact of early stress and the

developing microbiome within the context of

host genetic vulnerabilities on infants’ neuro-

development is critically needed.

Our preliminary data showed that cumula-

tive pain/stress events were significantly asso-

ciated with neurodevelopmental measures in the NICU, and infants who experienced more

pain/stress had higher levels of Enterobacteria (Phylum: Proteobacteria), a characteristic

pattern of dysbiosis, which are potential pathogens for immature infants, compared

with infants with fewer pain/stress experience.

In light of these results, the primary hypoth- esis driving the proposed research study is that cumulative pain/stress events in early

life combined with gut dysbiosis, defined as overabundance of Proteobacteria, and

specific genetic susceptibilities increase the risk for neurodevelopmental morbidity in preterm infants during early childhood. The proposed study will longitudinally recruit and

follow 200 preterm infants from NICU hos- pitalization until 18-24 months corrected age

(CA). Primary variables include cumulative

pain/stress events, gut microbiome patterns

Reprinted

with permission.

Multi-Omics Analysis: R01 Grant Application 475

and functions, host genetics (whole exome

sequencing to identify genetic variants), auto-

nomic responses, and neurodevelopmental outcomes including pain sensitivity.

Aim 1: Examine the impact of cumulative

pain/stress events in the NICU along with gut microbiome development on infant neurode-

velopmental outcomes over the short- (NICU stay) and long-term (follow-up).

H1A: Cumulative pain/stress events in the

NICU, while controlling for sex, feeding and environmental factors, will predict gut dysbiosis in the NICU and fol-

low-up visits. Thresholds of cumulative

pain/stress will be identified to predict

altered gut microbiome patterns and function, as well as neurodevelopmental

outcomes. H1B: Gut microbiome patterns and functions

will predict autonomic responses and neurodevelopmental outcomes in the

NICU and at follow-up visits.

Aim 2: Identify interaction effects of host

genetics, gut microbiome, and early life pain/ stress on infant neurodevelopmental out- comes, while controlling for sex, feeding and environmental factors over time.

H2A: Host genetic variation will be asso-

ciated with specific gut microbiome patterns and functions in the NICU and

at follow-up visits. H2B: A combination of early life pain/

stress, gut microbiome and host genetic variation will significantly contribute to neurodevelopmental outcomes over time.

Aim 3 (Exploratory): Based on our prelim-

inary data, more than 40% of the study

sample will be twins. Because twins are

matched for genetic traits and/or environmen- tal factors, they can serve as self-controls. We

will use monozygotic and dizygotic twin-pairs

in our study to explore the impact of different

levels of cumulative pain/stress on twin-pairs, the gut microbiome, neurodevelopmental

outcomes and other growth parameters, as

well as compare the outcomes with those of

non-twin infants over time.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

476 APPENDIXO #8

Using a multi-omic approach, the study

will be the first to discover the effect of early life pain/stress on the brain-gut-microbiota

axis and host genetics, and explore the

dynamic interplay of host-microbial genomes to predict infant developmental outcomes. By

identifying the factors that impact infant neu-

rodevelopment, we anticipate that the knowl- edge gained could lead to future research

testing new predictive and interventional

strategies to further improve preterm infant

health while reducing burdens and costs to families and society. ‘

= Summary Sheet

1RO1NR016928-01A1 Cong, Xiaomei New Investigator

Resume and Summary of Discussion: This

application proposes to examine the impact

of early life pain/stress events on gut micro-

biome development and neurodevelopmental outcomes on neonatal intensive care (NICU)

infants. Reviewers were very enthusiastic

about the innovation in exploring the molec- ular fingerprint of preterm Infant neurode-

velopment since mechanisms that regulate

infants’ neurodevelopment remain largely unknown. The multidisciplinary investigative

team is outstanding and this study builds onto

their previous work. The study was consid-

ered significant and investigators were very

responsive to previous concerns. Minor weak-

nesses include a lack of detailed discussion on

other factors outside the NICU that influence neurodevelopment at a young age and a slight

overlap with work that the Investigator have already done. Overall, reviewers agreed that the study could have a high impact on the identification of specific causal pathways

between pain/stress events and neurodevelop-

mental outcomes, and will also contribute to

the overall understanding of the development of the human microbiome.

Description (provided by applicant): Despite substantial gains in survival of preterm infants, concerns remain regarding

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Multi-Omics Analysis: R01 Grant Application

the significant neurological morbidity and long term adverse outcomes related to insults

on the immature immune and brain-gut-

microbiota systems affected by painful/stress- ful early life experience during the neonatal intensive care (NICU) stay. Our preliminary

K23 results show that cumulative pain/stress

events are significantly associated with higher abundance of gut Enterobacteria (Phylum: Proteobacteria). a characteristic pattern of dysbiosis, which may contribute to neurode-

velopmental deficits during the NICU stay. In

light of these results, the primary hypothesis driving this research is that cumulative pain/ stress experienced in earty life combined with gut dysbiosis and specific genetic susceptibil-

ities increase the risk of neurodevelopmental morbidity in preterm infants during infancy

and early childhood. A prospective longitu- dinal design will be used to examine: 1) the impact of cumulative pain/stress events in the

NICU along with gut microbiome develop- ment on infant neurodevelopmental outcomes

over the short-(NICU stay) and long-term (follow-up): 2) interaction effects of host

genetics, gut microbiome. and early life pain/ stress events on infant neurodevelopmental outcomes, while controlling for sex, feeding and other environmental factors over time:

and 3) the impact of different levels of pain/ stress experiences on the gut microbiome and neurodevelopment outcomes as well as

other growth parameters using twin-pairs. The proposed 4-year project will recruit and follow 200 preterm infants (160 infants in

the final analysis considering the attrition)

during NICU hospitalization and until 18-24

months corrected age (CA). Primary measures

in the NICU include daily pain/stress events (NICU Infant Stressor Scale), gut microbiome

patterns and function (stool sample: twice/ week; 16S rRNA gene and metagenomic

sequencing), host genetics (whole exome

sequencing to identify genetic variants that

effect neuro-gut-immune signaling), auto- nomic responses (weekly; heart rate variabil-

ity) and neurodevelopmental outcomes (at 36

weeks CA; NICU Network Neurobehavioral

Scale). At follow-up visits, gut microbiome.

Reprinted

with permission.

i APPENDIXO #8

neurodevelopmental outcomes, including pain

sensitivity will be measured at 4, 8-12, and

18-24 months CA.

Public Health Relevance: Neurodevelop-

mental deficits associated with preterm

birth cost the United States over 26 billion annually and include hidden burdens for families. Cumulative stress and painful events have been shown to alter neuro-gut-immune

signaling in preterm infants cared for in the neonatal intensive care (NICU). however,

the precise mechanisms by which these

events impact neurodevelopmental outcomes

remains unclear. The proposed research aims to use multi-omic approaches to elucidate the

specific causal pathways between pain/stress events, neuro-gut-immune signaling, genetic

variation and neurodevelopmental outcomes

over time in order to improve preterm infant health, decrease costs, and reduce burdens to

preterm infants’ families and society.

@ Response to Reviewers

The revision of this proposal (1 RO1

NRO16928-01) is being submitted under the

NIH consecutive review cycle option for new investigator RO1 applications (NOT-OD-

11-057). The proposal has been enhanced in response to the reviewers’ recommendations,

which are noted below. Revisions in the pro- posal appear in italics.

CONCERN: Expand upon the discussion

of potential interventions, or knowledge gained that will lead to future research on

prevention strategies.

Response: We have expanded upon the sections describing the knowledge to be gained that holds high potential for develop-

ment of future interventions. In particular,

the study proposes to identify pain/stress thresholds, gut dysbiosis, and genetic “risk”

variants that contribute to neurodevelop- mental deficits. This knowledge is crucial for guiding therapeutic interventions. Depending

on the mechanisms, which will be a focus of

the proposal, future interventions may include

Reprinted

with permission.

Multi-Omics Analysis: R01 Grant Application 477

more precise regulation of care activities

according to the pain/stress level of the infant,

consistent use of skin to skin exposure and

mother’s own milk feeding to prevent and/or treat gut dysbiosis, and possibly administra- tion of probiotics or transplant of beneficial microbiota.

CONCERN: Further discussion about how

other factors (e.g., enriched vs. non-enriched

NICU environment) known to affect develop-

ment at this early stage of life may influence the project.

Response: Environmental factors have been discussed in the Significance section and

added to the theoretical framework. The pro- posed study will be conducted in one NICU,

even though at two sites, thereby providing

equal exposure to identical environmental conditions for all infants, including open-bay arrangement, services provided by the same medical staff, and use of identical practice policies (i.e., feeding, infection control, and

control of noise and light). During follow-up, we have added a measure to assess quality

of the child care environment to evaluate potentially environmental factors that may influence neurodevelopment.

CONCERN: More detailed discussion on the background for selecting the candidate

genes. Response: Detailed discussion for select-

ing candidate genes has been added in the

Approach section. CONCERN: Detailed discussion about

any significant preliminary data of twins and

how twins will be included and data will be

analyzed. Response: Preliminary data of twins have

been included. Detailed discussion about how

twins will be included has been clarified in the

Approach section. We have expanded upon

the analysis plan of the twin data (Aim 3) in the Analysis section to clarify how it will be

analyzed. CONCERN: More detailed descrip-

tion about data collection and scoring of

NISS data; why one 30-min period of HRV assessment at each time point is sufficient to

measure autonomic system responses

Generating and Assessing Evidence for Nursing Practice (11th ed.)

478 APPENDIXO #

Response: Methods of NISS data collec-

tion, scoring and analysis have been clarified in the Approach section.

Through our pilot work, we have demon- strated that “one 30-min period of HRV assessment at each measurement time point”

is able to reflect differential autonomic system

responses among infants. We have devel-

oped a standard protocol for this measure, which will be used in the proposed study.

CONCERN: Further discussion whether sex as a variable to be important in the project.

Response: Sex will be an important factor and has been addressed in the Significance

and Approach section.

CONCERN: Concern about a lack of preliminary data to support that pain/stress

and gut microbiome in the NICU will be

correlated with neurodevelopment at 18 to 24 months corrected age.

Response: The findings from our pilot work include associations among cumulative

pain/stress events, gut dysbiosis and differ- ential neurodevelopmental outcomes. Gut

microbiome studies in animal models have

shown that stress modulates microbiome establishment and absence of a normal

Multi-Omics Analysis: R01 Grant Application

microbial profile is resistant to the restoration of a normal gut flora later in life, which can result in neurodevelopmental alterations. The proposed study is designed to precisely

identify these mechanisms in human infants/

children. CONCERN: Further discussion about

power analysis plans taking account for the

number of candidate genes and attrition rate. Response: We apologize for the lack of

clarity regarding sample size. Power anal- ysis and sample size estimation have been

re-adjusted and presented in the Approach section.

CONCERN: Budget — The PI has an ongo- ing project funded by an internal award from

UConn that appears to overlap with the aims

of this application. Response: The ongoing project has com-

pleted data collection, and final data analysis is underway. However, the K23 study was

not designed to assess causal pathways and

only included short-term neurodevelopmen-

tal outcomes. Therefore, we do not agree that there is overlap with the proposed application.

Reprinted

with permission.

APPENDIX P.

ANSWERS TO SELECTED

RESOURCE MANUAL EXERCISES

= Chapter 1

C. APPLICATION EXERCISES

Exercise C.1: Questions of Fact (Appendix A)

a. Yes, this was a systematic study that

tested the effectiveness of two alternative programs in improving drug and alcohol abstinence among recently incarcerated

homeless women. b. This is a quantitative study. The research-

ers systematically assessed several out-

comes (e.g., abstinence, prison history,

social support, depression) using measures

that yielded quantitative information.

c. The underlying paradigm was positivism/

post-positivism.

d. Yes, the study involved the collection

of information through the senses (i.e.,

through scrutiny of study participants’ responses to series of questions and through a urine analysis).

e. This study was applied research—there was a practical problem that the research- ers wanted to solve (i.e., a problem

relating to drug use among previously

incarcerated women, which put them at

risk of returning to prison).

f. Yes, this study was concerned with assessing whether the carefully developed Dialectical Behavioral Therapy-Case

Management intervention caused women

to refrain from using drugs and alcohol. In this and most studies, there is an underly- ing assumption that phenomena are mul- tiply determined. Thus, the participants’

abstinence behavior is caused by a number

of factors (e.g., depression), and what is being tested in this study is whether one of the “causes” of abstinence is participation in the special intervention.

. The purposes of the study could be

described as prediction and control—the

investigators examined a possible method of

controlling (reducing) drug and alcohol use. . Yes, this study directly addressed a ques-

tion relevant to the treatment of homeless recently incarcerated women—a Therapy question. The results of this study,

together with those from other similar

studies, could provide guidance about evidence-based ways to help such women

manage their lives and their use of sub-

stances after release from prison.

Exercise C.2: Questions of Fact

(Appendix B)

a. Yes, this was a systematic study of the infant feeding beliefs and the day-to-day

feeding practices of nurses working in a

neonatal intensive care unit (NICU).

. It was a qualitative study. The researcher

used loosely structured methods (con- versational interviewing and observation allowing for personal interactions) to cap- ture in an in-depth fashion the experiences

of nurses in the NICU, relative to actual

bedside feeding practices. The underlying paradigm for this study is

constructivism (naturalism).

Yes, the study involved the collection of information through the senses (e.g.,

through conversations with nurses and

through direct observation of practices in

the NICU).

Reprinted with permission from Nursing Research, 2011;60(2):82-91. 479

480 APPENDIXP

. This study might best be characterized as basic—the purpose was to gain a bet- ter understanding of the structure and processes of the culture in a particular NICU. Interventions could, however, be

designed to take the study findings into

account; studies of such interventions

would be considered applied

research. . The purpose of the study can be described

as exploration into the everyday world of NICU processes and transactions, with

emphasis on actions and interactions relat-

ing to infant feeding. . No, this study was not explicitly cause-probing.

. This study addresses the EBP purpose

described in the textbook as “Meaning/

Process,” i.e., developing an in-depth

understanding of the NICU environment

and processes relating to infant feeding practices.

@ Chapter 2

B. STUDY QUESTIONS

Exercise B.1

ped}

ss it a Gt tg oe CO OF Os Og

C. APPLICATION EXERCISES

Exercise C.1: Questions of Fact

(Appendix C) a. The purpose of the evidence-based project

was to develop, implement, and evaluate

Answers to Selected Resource Manual Exercises

the effectiveness of a standardized nursing procedure to increase the identification of depression in family members of active

duty soldiers. . The setting for the project was a military

family practice clinic located on a U. S.

Army infantry post in Hawaii. . The project was guided by the Iowa Model of Evidence-Based Practice to

Promote Quality Care. . The authors described the project as having both a problem-focused trigger and a knowledge-focused trigger. With regard to the former, the introduction indicated that “the absence in this clinic of a systematic method to screen fam- ily members of deployed soldiers for depression and the inability to estimate

rates of depression in this clinical popu-

lation were the problem-focused triggers

for this project.” They cited national

standards and guidelines calling for the screening of all adults for depression

in primary care settings as the knowl-

edge-focused triggers. . There were three authors of this report, and presumably, they were major team

members on this project. Two authors

were master’s-prepared officers in the U. S. Army Nurse Corps, and the third

was an instructor at the University of

Hawaii. The article also indicates that a

“multidisciplinary panel of stakehold- ers,” which included advance practice registered nurses (APRNs), physicians,

certified nurse assistants, registered nurses

(RNs), a psychologist, and clinic admin-

istrators, formed the EBP team. It is not

unusual for EBP project teams to com- prise research and clinical staff and to be multidisciplinary.

. The report did not discuss implemen-

tation at length, but it did state that the project team was led by a change

champion (an APRN) and an opinion

leader (a physician) who were persuasive

and influential in the clinic. The article stated that “the EBP project received

Generating and Assessing Evidence for Nursing Practice (11th ed.)

< APPENDIX P @

enthusiastic support throughout the organization and at the highest levels of nursing leadership.”

The report described the study that was undertaken as a pilot study.

Yes, one of the purposes of this pilot study

was to evaluate the effectiveness of the newly developed practice guideline for screening for depression.

Exercise C.2: Questions of Fact

(Appendix K) a. Yes, the article by Chase and colleagues

described a systematic review under-

taken to summarize evidence on the

effectiveness of interventions designed to promote medication adherence among

patients with coronary artery disease.

The review team used meta-analysis to

statistically integrate findings from mul-

tiple studies.

Systematic reviews are an especially important type of pre-appraised evidence.

The meta-analysis in this study integrated

information from several studies, includ-

ing randomized controlled trials (RCTs),

and so evidence from this study would be at the top rung of the evidence hierarchy

portrayed in Figure 2.2.

On the 6S hierarchy of evidence sources,

this systematic review would be at level 4:

Syntheses. The researchers stated that “The purpose

of this meta-analysis was to determine

the overall effectiveness of interven- tions designed to improve medication

adherence among adults with CAD.” The researchers also stated a secondary

purpose—to examine whether certain

features of the study “moderated” inter- vention effectiveness. This means that the

researchers looked for evidence not only

of whether interventions are effective in increasing medication adherence, but also whether certain features of the interven- tion (e.g., whether the intervention was

delivered by nurses or others) increased

the benefits.

Answers to Selected Resource Manual Exercises 481

@ Chapter 3

EXERCISE B.2

a. Independent variable (IV) = participation versus nonpatrticipation in assertiveness

training; dependent variable (DV) = psy-

chiatric nurses’ effectiveness

IV = patients’ postural positioning; DV = respiratory function

. IV = amount of touch by nursing staff; DV = patients’ anxiety

IV = frequency of turning patients; DV =

incidence of decubitus IV = history of participants’ abuse during their childhood; DV = abuse of their own

children

IVs = patients’ age and gender; DV = toler-

ance for pain

IV = pregnant women’s number of pre- natal visits; DV = labor and delivery

outcomes IV = children’s status of having or not having a chronic illness; DV = levels of depression

IV = gender; DV = compliance with a

medical regimen IV = participation vs. nonparticipation in

a support group among family caregivers

of AIDS patients; DV = coping

. IV = time of day; DV = hearing acuity

among the elderly IV = location of giving birth—home versus

hospital; DV = parents’ satisfaction with

the childbirth experience . IV = type of diet in the outpatient setting

among patients undergoing chemotherapy; DV = incidence of positive blood cultures

EXERCISE B.5

Experimental studies would not be con-

ducted in the ethnographic tradition. In the study described, receipt of relaxation

therapy would be the independent variable

and pain would be the dependent variable.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

482 APPENDIXP ®& Answers to Selected Resource Manual Exercises

c. In grounded theory studies, researchers do not study “lived experiences” —that

would be the focus of a phenomenologic

inquiry.

d. In phenomenologic studies, there would

not be an intervention. e. In an experimental study, the data col-

lection plan would be developed well in

advance of introducing an intervention.

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX D)

a. The lead researcher for this study was Dr. Hyerang Kim, a nurse researcher and

postdoctoral fellow at Johns Hopkins University. Three other authors were nurse

researchers at the same university, and one

author was the President of the Korean Resource Center. All members of this team

have a doctoral degree.

b. On the first page of the article, there is a note that the researchers received a grant

from the National Center for Research Resources within the U.S. National Institutes of Health.

c. The study participants were 28 Korean

Americans with high blood pressure.

d. The independent variable in this study

was exposure to a culturally tailored dietary intervention (DASH). In this

study, the researchers gathered outcome

information before and after exposure to the intervention, so the “before” state

represents the absence of exposure to the intervention. The researchers created this independent variable. It is not, however,

inherently an independent variable. For example, if the program was available

to people in the community, one could

ask questions about factors influencing people’s decision to participate in the

program. In such a situation, program

participation (or not) would be the dependent variable.

e. There were several dependent variables

in this study. The primary outcomes

were blood pressure values, but other

outcomes of interest included various biochemical measures from blood and urine tests, such as cholesterol. None of

these is inherently a dependent variable. For example, blood pressure values could be studied as a potential cause of health

problems. . No, the report did not specifically use the

terms independent or dependent variable.

The term “outcome” was used in lieu of

dependent variable. . The data in this study were primarily

quantitative. Kim and colleagues measured their outcome variables in a form that yielded numeric information. However, it was briefly noted that some qualitative information was also collected to better understand the process of implementing

the intervention. . The researchers were interested in a

possible cause-and-effect relationship: the relationship between participation

in the intervention on the one hand

and improved outcomes on the

other. i. This study was experimental (more

precisely, it was guasi-experimental, a

type of design we describe in Chapter

9). The researchers controlled the inde-

pendent variable (the intervention) and

gave it to people after they made pre-

intervention measurements of the out- come variables.

j. Yes, this study involved an interven-

tion—a special dietary intervention for

people with high blood pressure. Yes, Kim and co-researchers analyzed

their data statistically. The analysis of the qualitative data was not described. Yes, an IMRAD-type format was fol- lowed. There was a short introduc- tion that described the study purpose,

briefly reviewed relevant literature, and discussed the projects’ significance. Both the method and results sections had several subsections. Finally, there was a discussion section that inter-

preted the findings and suggested some implications.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

E APPENDIX P

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX E)

a. There was only one researcher in this study—which is not unusual in qualitative studies. Jeanne Cummings, a doctorally-

prepared nurse, was (at the time the article

was published) a visiting professor the City University of New York.

. According to the note at the end of the article, this research was conducted with-

out formal funding. . The study participants were 12 dyads of

storytellers and listeners. The storytellers were people who had been involved in a widely-publicized disaster—the crash land-

ing of U.S. Airways Flight 1549 into the Hudson River in January 2009. (The story

of this event was portrayed in a popular

movie—Scully—in 2016). The listeners in

Cummings’ study were people with whom the storytellers had shared the story of the

traumatic event.

. The context of the study was the crash

landing of the airplane into the Hudson River. There was, however, no specific set-

ting for the storytelling (which occurred in multiple, varied settings). Almost all study

participants were interviewed in person

(only 3 were interviewed over the tele-

phone), but information about where the

interviews took place was not provided.

. The key concept was the storytelling

aspect of a particular traumatic event.

. No, there were no independent variables or dependent variables in this qualitative study.

. The data for this study were qualitative.

. Although this study did not explicitly focus on relationships, the analysis revealed that the nature of the relationship between the storyteller and listener did

“color” or affect the listener’s and story- teller’s experience during the telling of the

story (Theme 5). . This study was described as an interpretive

phenomenologic study. . This study was nonexperimental. . There was no intervention in this study, as

is usually the case in qualitative inquiries.

Answers to Selected Resource Manual Exercises 483

. The study did not report any statistical

information (e.g., the average age of the

participants). The study involved the qual- itative analysis of rich, narrative data.

. Yes, the report followed the IMRAD format. There was an introduction, a

methods section, results section, and a

discussion.

@ Chapter 4

EXERCISE B.4

2a. IV =type of stimulation (tactile vs. verbal); DV = degree of physiological arousal

2b. IV = infant birthweight; DV = risk of hypoglycemia

2c. IV = use vs. nonuse of isotonic sodium

chloride solution; DV = oxygen saturation

2d. IV = fluid balance; DV = degree of suc- cess in weaning patients from mechanical

ventilation

2e. IV = patients’ gender; DV = amount of

narcotic analgesics administered 3a. IV = prior blood donation vs. no prior

donation; DV = amount of stress during

the donation 3b. IV = amount of conversation initiated by

nurses; DV = patients’ ratings of nursing

effectiveness 3c. IV = ratings of nurses’ informativeness;

DV = patients’ amount of preoperative

stress 3d. IV = receipt versus non-receipt of foot

massage; DV = degree of agitation

3e. IV = type of delivery (vaginal vs. cesar- ean) DV = incidence of postpartum

depression

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX F)

a. The problem statement encompasses most

of the introduction in the Eckhardt et al. report; the argument for the study incor-

porates the review of relevant literature.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

484 APPENDIXP #9

The problem statement is most succinctly stated in the abstract: “Fatigue is a prev-

alent and disabling symptom associated

with many acute and chronic conditions,

including acute myocardial infarction and

chronic heart failure. Fatigue has not been

explored in patients with stable coronary heart disease (CHD).”

. The authors stated three objectives

in a section of the abstract labeled

“Objectives.” Then, at the end of the

introduction (just before the heading “Organizing Framework,” they reiterated

their three purposes. In purpose 1, they

used the verb describe: To describe fatigue

(intensity, distress, timing, and quality) in

patients with stable CHD. The verb deter- mine was used for the next two purposes:

(2) to determine if specific demographic (gender, age, education, income), physio-

logical (hypertension, hyperlipidemia), or

psychological (depressive symptom) vari-

ables were correlated with fatigue; and (c)

to determine if fatigue was associated with health-related quality of life. As noted in the text, we think a different verb (e.g.,

explore, examine) might be preferable to determine, because determinations can-

not truly be made based on data from a

small sample—in this case, 102 patients.

It might also be noted that the researchers

had another purpose that was not stated in the introduction: to examine factors

related to fatigue separately for men and women.

. The report did not explicitly state research

questions, although questions could be inferred from the purpose statement. For example, the question corresponding

to the first descriptive purpose might

be: What are the fatigue characteristics

(intensity, distress, timing, and quality) of

patients with stable CHD?

. No hypotheses were formally stated.

. The two purposes relating to factors

correlated with fatigue (2 and 3) could

have been expressed in hypotheses. For

example, for the third purpose, it might be hypothesized that patients with higher

Answers to Selected Resource Manual Exercises

levels of fatigue intensity or interference would have less favorable quality of life

outcomes. f. Yes, the researchers used hypothesis-

testing statistical tests.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX B)

a. There is no single paragraph that states

the research problem under study. The argument for the study, which involved examining nurses’ infant feeding beliefs and their actual behaviors relating to

feeding in the NICU, was developed in the three introductory paragraphs. The

first paragraph summarizes evidence

about the benefits of breastfeeding. The second paragraph documents evidence

that rates of breastfeeding are low for NICU infants and that NICU nurses can play a critical supporting role. The

third paragraph notes that “breastfeed- ing beliefs do not occur in a vacuum,”

and so Cricco-Lizza explored the NICU

feeding culture to better understand how nurses’ beliefs might develop and find affirmation.

b. Cricco-Lizza stated the purpose at the end

of the report’s introduction: “The purpose of this study is to examine the infant feed-

ing beliefs and day-to-day feeding prac- tices of NICU nurses.”

c. Specific research questions were not

articulated.

d. No hypotheses were stated—nor would

one have been appropriate in this ethno- graphic study.

e. No, no hypotheses were tested.

Qualitative studies do not use statistical methods to test hypotheses.

f. Cricco-Lizza has been involved in studying breastfeeding and nurses’ roles in infant feeding practices for over a decade. We can see that this is true by the fact that

papers for several of her earlier studies are cited in the bibliography for this report.

Furthermore, the third paragraph of this

Generating and Assessing Evidence for Nursing Practice (11th ed.)

a APPENDIX P @

paper notes that “the current report is part of a larger study that examined mul-

tiple contexts for infant feeding for nurses within one NICU.”

= Chapter 5

EXERCISE B.2

t+ ete

pe moon FP

Neoplasms

Jet lag syndrome Alcoholism Telemedicine

Pressure ulcer Pulmonary disease, chronic obstructive

Hypochondriasis Cognitive dysfunction Airway extubation

Somnambulism

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX K)

Chase and colleagues’ review was a sys- tematic review—a meta-analysis.

Yes, the introduction described the

research problem that the researchers addressed. The problem might be stated as followed: Medication therapy provides known benefits for the secondary preven- tion of coronary artery disease (CAD). Yet

many patients do not adhere to prescribed

medication regimens, and such nonad-

herence has been linked to poor health outcomes. Interventions to improve adher-

ence in CAD patients have been devel- oped and tested, but findings about their effectiveness have not been systematically

integrated. Yes, there was a statement of purpose in the abstract: “The purpose of this meta- analysis was to determine the overall

effectiveness of interventions designed to improve medication adherence (MA)

among adults with CAD. In addition, sample, study design, and intervention

Answers to Selected Resource Manual Exercises 485

characteristics were explored as poten-

tial moderators to intervention effec-

tiveness.” Additionally, two research

questions were stated at the end of the Introduction: (1) What is the overall

effectiveness of MA interventions on MA outcomes among patients with CAD?

(2) Does intervention effectiveness vary

based on intervention, sample, or design

characteristics?” For students who not

yet understand what the researchers

meant by “moderators” in the purpose

statement, the questions may be easier

to understand. The researchers were

interested in exploring whether beneficial

effects on interventions was different for

different types of people, for different types of interventions, and when different

research designs were used. . The researchers used 13 different elec-

tronic databases in their literature

search, including ones we discussed

or mentioned in Chapter 5 (PubMed,

CINAHL, Cochrane’s CENTRAL,

PsycINFO) and other databases we did

not mention.

. The authors used many keywords (and MeSH terms) that included the following: patient compliance, medication adherence,

drugs, prescription drugs, pharmaceutical preparations, generic dosage, compliant,

compliance, adherent, adherence, non-

compliant, noncompliance, nonadherent,

nonadherence, medication(s), regimen(s),

prescription(s), prescribed, drug(s), pill(s),

tablet(s), agent(s), improve, promote,

enhance, encourage, foster, advocate,

influence, incentive, ensure, remind, opti-

mize, increase, impact, prevent, address,

decrease. . Yes, the report indicated that “ancestry

searches of prior reviews’ bibliographies

were conducted.” . The report did not state that their search was restricted to English-language pub- lications. It is unclear if there were any language restrictions—although it seems unlikely that studies described in all lan-

guages would have been included.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

486 APPENDIXP &

. This meta-analysis included 24 studies. . All studies included in the review were

quantitative; meta-analyses integrate

quantitative findings.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX L)

a. Beck undertook a systematic review of

qualitative studies relating to birth trau- ma—a type of metasynthesis that is called

a metaethnography, as explained in more

detail in Chapter 30. In this case, the meta-

synthesis involved synthesizing results from multiple analytic approaches in a research

program by the same researcher (Beck).

The purpose of this metasynthesis was to integrate and amplify findings from qualitative studies on birth trauma and

resulting posttraumatic stress disorder. Beck indicated her purpose in the first paragraph.

This particular synthesis integrated

information from qualitative studies on traumatic births that had previously been

conducted by Beck herself in her extensive

program of research on traumatic births.

Six of Beck’s prior studies were included in this metasynthesis.

The six studies in the review included five phenomenologic studies and one narrative analysis (see Chapter 22).

= Chapter 6

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX F)

a. Eckhardt and colleagues stated that they

used the Theory of Unpleasant Symptoms as the organizing framework for their study.

The Theory of Unpleasant Symptoms was

not described in the textbook, but it is a

theory that has been used by many other nurse researchers.

Answers to Selected Resource Manual Exercises

. The theory was not described in detail, but this likely reflects space constraints in journal, not the authors’ negligence.

. Yes, the article stated that the Theory of

Unpleasant Symptoms was the basis for the researchers’ framework, but that they adapted it for this study. The report did

not describe the specific adaptations that were made.

. Yes, a schematic model of the organizing framework used in this research was pre-

sented in Figure 1. . The key concepts in the model were: (1)

physiologic factors (e.g., hypertension, co-morbid conditions); (2) psycholog-

ical factors (e.g., depressed mood); (3)

situational factors (e.g., age, sex, educa-

tion); (4) symptom experiences (fatigue

severity, fatigue interference); and per-

formance (quality of life and functional status)

. The schematic model did not show

connections among concepts in a tra-

ditional manner, namely with arrows

between boxes. However, it seems rea-

sonable to conclude that the model was intended to be read from the top down. That is, the physiologic, psychologic,

and situational factors are presumed to affect patients’ symptom experience,

which in turn influences performance concepts.

. The report did not articulate formal

conceptual definitions of each construct

in the model. For example, there was no

conceptual definition of “quality of life.” However, operational definitions of all

concepts were provided. i. No, the researchers did not state formal

hypotheses deduced from the conceptual framework—although they tested some, and these are consistent with our reading

of the model, as explained in question g. For example, one hypothesis they tested was: Fatigue intensity is related to situa- tional factors (age, income), psychological

factors (depression), and physiologic fac- tors (e.g., hypertension).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

fe APPENDIX P @

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX G)

a. No, the authors did not describe any a priori framework or theory that guided

this research. For example, there was no mention of symbolic interactionism. Given

space constraints in journals, however,

this does not mean that the study lacked a conceptual framework.

Yes, the purpose of the study was to gen-

erate a theory that was grounded in the experiences of the study participants. The

authors referred to their grounded theory as Reconciling in response to fluctuating needs.

Yes, Figure 1 of the report was a sche- matic model depicting the researchers’ grounded theory. The figure was a good way to illustrate three overlapping phases of reconciling (getting ready, getting into it, and getting on with it, as well as three

subprocesses of reconciliation: navigating, safekeeping, and repositioning.

Inasmuch as this was a grounded the- ory study, no hypotheses were tested. A

grounded theory study sometimes results in the identification of hypotheses that can be tested in subsequent quantitative studies.

@ Chapter 7

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

a. Yes, in the last paragraph of the section labeled “Design, Sample, and Site,” the

researchers indicated that the study proto- col was approved by the university’s IRB.

Technically, the study participants do not fit into a category deemed to be vulnerable, and yet these women, recently released from prison and homeless, are at risk for many unfortunate life outcomes. It appears that their at-risk status was taken into account in designing the intervention and implementing

the study. Of particular note, all women were given a health-related treatment.

Answers to Selected Resource Manual Exercises 487

c. There is no reason to suspect that partici-

pants were subjected to any physical harm

or discomfort or psychological distress.

Neither the main program nor the com- parison intervention appear to have been

stressful. The fact that so many of the women stayed in their 12-week programs

and completed all components of them

(80%) suggests that the participants them- selves saw benefit in the programs.

. It does not appear that participants were deceived in any way.

. There is no reason to suspect any coercion

was used to force unwilling people to participate in the study. All women were

offered small monetary incentives, but it

is unlikely that they were large enough to exert pressure on the women.

. The report indicated that written consent was obtained from all participants in two phases. In the initial phase, the project was described and those interested in continu-

ing were read a brief consent script and

asked to sign a consent form. After deter- mining the women’s eligibility, a research

staff person read and discussed a detailed informed consent form, and answered

questions. It appears that participants vol-

untarily agreed to participate in the study.

. The article did not describe the steps the researchers took to protect the privacy and confidentiality of participants—but the article did say that initially the women met

with a research staff person in one-on-one sessions in a private location. Presumably

adequate protections were in place, given

that approval for the study was given by a

university IRB. Statements regarding pri-

vacy and confidentiality undoubtedly were

made in the informed consent form.

EXERCISE C.2: QUESTIONS OF FACT

(APPENDIX B)

a. Yes, the report indicates that this study was approved by university- and hospital-

based human subjects committees, pre-

sumably the committee in the hospital

Generating and Assessing Evidence for Nursing Practice (11th ed.)

488 APPENDIXP

where the study took place and also the committee of Cricco-Lizza’s university,

the University of Pennsylvania. The article also states that “the nursing and medical directors granted permission for data col-

lection in this NICU.” . The focus of the study was nurses in the NICU, not the mothers or their infants.

The nurses would not be considered

vulnerable. . Participants were not subjected to any

physical harm or discomfort. Nurses were observed performing their normal duties. It is possible that there was a cer-

tain degree of self-consciousness when

the study started, but it is likely that the

nurses became accustomed to the presence of the researcher, who was probably con-

sidered a colleague. . Participants were probably not deceived.

The article states that “the nurses were informed about the study through the

intranet, staff meetings, and face-to-face

interactions in the NICU.” The nurses

under observation knew that Cricco-

Lizza was a nurse researcher who was

interested in learning about their per-

spectives on infant feeding—although

possibly the parents who were some-

times included in the observations (e.g., during nurse-run breastfeeding support

meetings) did not have information about the study.

It does not appear that any coercion was involved.

. The report stated that the researcher

obtained written informed consent from the 18 key informants who were formally

interviewed. Informed consent was not

obtained from the 114 nurses who were considered “general informants,” nor

from any family members.

Cricco-Lizza stated that the interviews

with key informants took place in a pri-

vate room near the NICU at times chosen by the nurses. She did not explicitly dis- cuss who had access to the audiorecorded interviews or the transcripts—but she

Answers to Selected Resource Manual Exercises

did state that the nurses “were assured of the confidentiality of their responses.” No names were used in the report. When verbatim quotes were presented in the report, she said things such as:

“One nurse said” or “one key informant

stated.”

= Chapter 8

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX D)

a. Yes, the study involved a test of an inter- vention relating to dietary practices,

designed to help manage hypertension in Korean Americans with high blood pressure. Yes, Kim and colleagues compared a sin-

gle group of people (those exposed to the intervention) at two points in time, namely

before and after the intervention.

The design was a within-subjects

design. There was a single group, whose

outcomes at two points in time were

compared.

This study was longitudinal. Data were

collected from study participants three times: before the intervention, and then 4

weeks and 10 weeks later, at the end of

the intervention.

The study was undertaken in a single com-

munity center in the Baltimore (Maryland)

area. Participants were recruited by refer-

rals from community physician networks

in the Baltimore-Washington DC metro- politan area.

The primary method of data collection was via biomarkers. There were also some self-reports: Participants maintained a 3-day dietary record at each data collec- tion point.

Yes, this was described as a pilot study of a culturally relevant approach to helping

patients manage high blood pressure. The purpose of the pilot study was to assess

Generating and Assessing Evidence for Nursing Practice (11th ed.)

cs APPENDIX P #

feasibility of translating and implement- ing the intervention, and to examine its

initial efficacy. One of the purposes of the article was to “share lessons learned during the development of this cultural guideline.”

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX 1!)

No, this study did not involve an intervention.

Yes, this study compared the perceptions

relating to the diagnosis and treatment of obstructive sleep apnea (OSA) among

patients who were adherent versus non- adherent to continuous positive airway

pressure (CPAP) therapy. The researchers

also conducted a supplementary analysis

in which married and unmarried patients were compared.

. Based on this article, the best way to

describe the design would be as mixed

design. The comparisons described in the

paper concerned different groups of peo-

ple, not the same people (i.e., adherers and

non-adherers)—between-subjects compar- isons. However, interview data were col-

lected twice (before and after CPAP use),

and so it would be possible to analyze the

data for within-subjects themes—i.e., how

things evolved over time. . The study was longitudinal. Data were col-

lected shortly after patients were diagnosed with OSA. They were interviewed again

shortly after initiating CPAP treatment.

. The sleep study was done in a Veterans Affairs medical center sleep clinic, and the interview data were mostly collected in the

clinic as well. Self-reports were the primary method of

data collection in this study. However, the

researchers also collected data from the CPAP machines regarding the number of hours per night participants adhered to the

CPAP therapy. No, this was not a pilot study.

Answers to Selected Resource Manual Exercises 489

= Chapter 9

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

a. Yes, there was an intervention in this

study. The purpose of the study was to

evaluate the effectiveness of a Dialectical Behavioral Therapy-Case Management (DBT-CM) intervention, in comparison

to a Health Promotion (HP) program, on drug and alcohol abstinence of recently incarcerated homeless women with a his- tory of drug use.

The design for this study was a fully ran- domized experimental design.

Yes, this study would be described as cause-probing. The researchers wanted to know if participation in the DBT-CM pro- gram caused changes in their use of drugs

and alcohol, relative to any effect from the HP program.

The independent variable was partici-

pation in the DBT-CM program versus

participation in the HP program. The

primary outcome variable was abstinence from using drugs 6 months after baseline.

Secondary outcomes were abstinence from

alcohol and abstinence from either sub- stance 6 months after baseline. Yes, randomization was used. Eligible par-

ticipants were enrolled and then randomly assigned to either the DBT-CM interven-

tion group or the HP control group. In the “Procedure” section, the report indicates

that participants were stratified on age and on a criminality screener, using urn

randomization. The report provided no information about allocation concealment. This does not mean that allocations were not

concealed. The control group strategy in this study

involved participation in an alternative intervention. The control intervention focused on health promotion and was also

a 3-month program.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

490 APPENDIXP «#® Answers to Selected Resource Manual Exercises

h. In this study, data were collected from

experimental and control group members

both before and after the interventions. Thus, we could call the design a pretest- posttest (before-after) experimental design. This study was a between-subjects design:

those in the intervention group were com- pared to those in the control group with

regard to their use of drugs and alcohol. The article did not say anything about

blinding, which often means that blinding was not used. It would not have been

possible to blind the participants, nor the people delivering the intervention, but

data collectors probably could have been

blinded. . The data were collected twice—before the

intervention and six months later. This

study could, therefore, be described as

longitudinal. It was also prospective: the

intervention (the “cause”) was delivered,

and then the “effects” (the abstinence out-

comes) were assessed subsequently.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX F)

No, there was no intervention in this

study.

The study design was nonexperimen-

tal. It had both descriptive components (e.g., What symptoms were frequently

reported?), and correlational components

(What factors were predictive of dyspnea duration before seeking care?) The article did not articulate a cause-

probing intent. The stated purpose was to describe fatigue in patients with stable coronary heart disease (CHD) and to

examine factors correlated with fatigue. The authors were careful to avoid causal

language. Indeed, they specifically noted that, with regard to the observed relation- ship between fatigue and depression, it could not be ascertained whether fatigue caused depression, or depression caused fatigue. They also specially noted in their

conclusion that it would be desirable to

undertake longitudinal studies that might shed more light on the nature of the rela- tionship between these variables.

d. The main dependent variable in this study was levels of fatigue; the independent vari-

ables were demographic variables (gen- der, age, education, income), physiologic

variables (hypertension, hyperlipidemia),

and a psychological variable (depression). However, the authors also looked as

fatigue as an independent variable poten- tially affecting quality of life.

e. None of the variables in the study could be experimentally manipulated.

f. No, randomization was not used. This

was a nonexperimental study. g. This is a descriptive correlational study. It

could also be described as retrospective: Eckhardt and colleagues were interested in identifying predisposing factors that could predict levels of fatigue.

h. No, blinding was not used in this study.

i. No, this study was cross-sectional, and it

was not prospective. Data were collected

at a single point in time, and the factors

examined as possible predictors of fatigue could be considered retrospective in

nature—i.e., as potentially existing prior to fatigue.

= Chapter 10

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

a. Nyamathi and colleagues used random- ization to groups to control confounding

characteristics, which is the most effective

strategy possible. In one of their analyses, the researchers also used statistical con- trol, further controlling for such factors as prior drug use, rage, and scores on mea-

sures of mental health (Table 3).

b. No, this study could not have used a

crossover design. Once the participants received assistance and support from

the Dialectical Behavioral Therapy-Case

Generating and Assessing Evidence for Nursing Practice (11th ed.)

i APPENDIX P @

Management (DBT-CM) intervention pro-

gram, there would be no way for them to “unlearn” the lessons they learned.

. Through randomization, virtually all participant characteristics (e.g., age, race,

social support, mental health, etc.) were

controlled. Additionally, most participants were fairly homogeneous with regard to some factors that put them at risk for drug or alcohol use (e.g., recent incarceration,

history of homelessness, history of drug use).

. Yes, there was modest attrition. In both

groups, roughly 10% of the participants

did not complete the follow-up data col- lection: 116 of the original 130 who were

randomized were in the primary analysis sample. Given the population (whose liv-

ing arrangements were probably not sta-

ble), this is a modest rate of attrition over

a 6-month period.

. The report specifically described steps that were taken to ensure treatment fidelity.

. In this study, the programs were operated in three different sites, so it is unlikely

that “constancy of conditions” was main-

tained. On the plus side, the implemen-

tation of the program in different sites is more like real-world applications of the intervention.

. Because of the fact that two interventions were being compared, the treatments were not as distinct as possible. Although the

content of the programs differed, they

were both 3 months long with sessions

held in the same locations. A “no treat- ment” control group would have been a

more powerful comparison—but compar-

ing two programs was an ethically laud-

able decision and consistent with goals we discuss in Chapter 31 relating to the applicability of the evidence. Selection was not a threat in this study

because random assignment was used to

equalize the groups. Table 1 shows that the women in the two groups were com- parable at baseline in terms of age, race, education, psychosocial variables, and

incarceration frequency.

Answers to Selected Resource Manual Exercises 491

The rate of attrition in this study was

low—and at a comparable rate in both groups—and so the mortality would prob-

ably not be a major threat to the study’s internal validity.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX D)

a. The authors used a quasi-experimental

design—a 1-group pretest-posttest design.

This is a design commonly used in pilot tests of an intervention. The design would be described as a within-subjects design:

participants were compared at two points

in time, before and after exposure to the intervention.

. The independent variable for this study was participation in the K-DASH intervention.

The baseline data were obtained in the “no intervention” state and the follow-up data

were obtained during and after the inter- vention. The primary outcome variable was

blood pressure. Other outcomes included dietary intake variables (e.g., calories,

sodium) and variables from the analysis of blood and urine samples (e.g., cholesterol).

Randomization was not used in this pilot

study. In a pilot study such as this one, there ts

less emphasis on research control than

in a full-fledged trial. Research control is

particularly important when there are two

or more groups, when it is desirable to have the groups be as similar as possible at the outset by using strategies to control extraneous characteristics. Selection is not

a threat to internal validity in a one-group

design. Yes, history is a threat to the internal

validity of one-group pretest-posttest designs (See textbook Table 10.2). It is

possible (but unlikely) that something else

going on in the lives of study participants

influenced their dietary intake.

Two participants dropped out of the study. The initial sample size was 30, but only 28 completed the intervention

Generating and Assessing Evidence for Nursing Practice (11th ed.)

492 APPENDIXP &

and the follow-up data collection. Mortality was unlikely to be a major

threat to the internal validity of this

study. The rate of attrition was fairly low (less than 10%) and the findings

were fairly robust. Even if the two who

dropped out of the study had no change,

the results would likely remain statisti-

cally significant. . It does not seem plausible that improve-

ment in blood pressure and other clinical

variables occurred simply as a result of the passage of time. :

# Chapter 11

EXERCISE C.1:

. Clinical trial:

¢ The Nyamathi et al. study in Appendix

A can be called a clinical trial— a

randomized design was used to test the

effectiveness of alternative interven-

tions. In fact, this study could be called

a comparative effectiveness trial. ¢ The Kim et al. study in Appendix D

might be considered a Phase II clinical

trial because it was a pilot test of an

intervention; information was sought

about its feasibility, patient adherence, and its potential for effectiveness in

improving outcomes for Koreans with

hypertension.

b. Outcomes research:

¢ None of the studies in the appendi- ces would be considered outcomes

research.

c. Survey research:

¢ The Eckhardt et al. study (Appendix F),

although not conducted as a traditional

survey, has some features of survey

research. Data were collected entirely

by self-report, for example. Surveys typically involve asking questions of a

broader population than is the case in

the Eckhardt et al. study.

Answers to Selected Resource Manual Exercises

d. Needs assessment:

e None of the studies in the appendices would be considered a needs assess- ment, although the Eckhardt et al.

-study (Appendix F) could shed light on the needs of patients with coronary

heart disease. e. Replication research:

e The study by Kim and colleagues (Appendix D) might be considered a replication. The study tested whether

a previously tested intervention could

be translated for use with Korean Americans and yield similar evidence

of effectiveness as that found in earlier studies.

f. Secondary analysis:

¢ None of the studies in the appendi-

ces would be considered secondary analyses.

g. Methodologic research:

¢ The study by Caruso and colleagues

(Appendix J) would be considered

methodologic. The aim of this research was to develop and test an instrument

to measure the Cancer Worry Scale for use with patients receiving or consid-

ering breast cancer genetic counseling.

The instrument could have applications

in research and in clinical practice.

EXERCISE €.2: QUESTIONS OF FACT (APPENDIX H)

Yes, the Wilson et al. study can be described as a clinical trial of an individu- alized preoperative education intervention

for symptom management for patients undergoing total knew arthroplasty.

This study evaluated the education inter-

vention, but probably most people would not classify this as evaluation research.

The trial would be considered analogous to an impact analysis. The authors did not

mention any effort to study the process of implementing the intervention or analyz- ing its costs and benefits.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

. This study is not an example of outcomes

research. There is a heading labeled “Outcomes,” but this does not make

it outcomes research—this was not an

assessment of the overall benefits resulting from nursing practice.

. This study is not a survey, even though

some of the outcomes were self-reports. Surveys are typically undertaken with a

large and well-defined population, usually not a clinical population.

. No, this study was not an example of

methodologic research. The focus was substantive, not methodologic.

. The study was experimental. The researchers introduced an intervention and randomly assigned participants to the

experimental or the control group.

@ Chapter 12

EXERCISE C.1: QUESTIONS OF FACT

(APPENDIX M)

a. The setting for this quality improvement

project was a nurse-managed health clinic

(NMHC) serving rural areas of the state of Indiana.

. All four members of the QI team were

nurses. Given that the setting was a nurse-

managed clinic, the team composition is

not surprising.

. The authors identified the problem as low colorectal cancer (CRC) screening rates in

the NMHC. Figure 1 in the article shows

that in 2014, the rate was 33% at the NMHG, substantially lower than the 70% target rate set for the Healthy People 2020 initiative and lower than the U.S. national

rate of 62% in 2010. . The team identified 5 goals: (1) Reviewing

the CRC screening process used at the

NMHC; (2) Developing interventions to improve the rate; (3) Implementing the

improvement interventions; (4) Evaluating

whether improvement occurred; and (5)

Sustaining process changes.

APPENDIXP ® Answers to Selected Resource Manual Exercises 493

e. Yes, in this project an Institutional Review

Board (IRB) reviewed and approved the project.

. The team chose the Plan-Do-Study-Act

(PDSA) model for this project. Based on

the information in Table 1, which pro- vided a good overview of the methods

used, it appears that there were at least two cycles (e.g., there were two Plan

cycles from May-June, 2015 and August- September, 2015), but the number of

cycles was not explicitly stated. In fact, the

word “cycle” was not used in the article.

. The article did not provide much informa-

tion about how the team identified under- lying causes of the problem. There was no mention of a root cause analysis (RCA)

or RCA tools such as a fishbone analysis

or use of a Pareto chart. However, Table

1 did state that the team developed a

process flow map to visualize the current

process for encouraging CRC screenings

to patients—although they did not include

in the process flow map in their paper. Table 1 also indicated that the team “ana-

lyzed preintervention data with identifica-

tion of problems” and used the analysis and other sources to shape intervention

development.

. Table 3 of the article described the various

components of the QI intervention. This

included provider education (not described

in Table 3 but noted in the text of the article); provider reminders and decision support tools; patient education; and

patient reminders. The text also noted that provider feedback was used in their effort

to sustain process changes: “Monthly feedback was given to individual pro- viders and continues to be posted at the NMHC.” The importance of performance

feedback was discussed at some length in

the Discussion section of the report. i. The authors explicitly stated that they

conducted a literature review and iden-

tified strategies that had been used to address the problem of CRC screening

rates in other QI projects. In Table 1,

the authors noted that they incorporated

Generating and Assessing Evidence for Nursing Practice (11th ed.)

494 APPENDIXP &

information from the literature review

in developing the QI intervention.

. The basic design for this study was a before-after (pretest-posttest) quasi- experimental design. Data on CRC screen-

ing rates were collected for 200 patients

prior to the intervention in early 2015, and then for 200 patients after the inter- vention in January 2016.

. The team used two outcome measures: the

rate for CRC screenings ordered, and the

rate for CRC screenings completed.

. Yes, in addition to collecting quantitative data on screening rates during the “Plan”

and “Study” phases of the PDSA cycle, the team conducted semistructured interviews

with staff as part of the planning process. These interviews helped the team to iden- tify strengths and weaknesses of the exist- ing process, and staff also had suggestions for process improvements.

. Yes, the team concluded that the QI inter- ventions were successful in increasing

CRC screenings. Over the 1-year period,

the number of screening ordered for eligi-

ble patients increased from 38% to 75% of patients and the number of screening completed increased from 30% to 58% of patients (Figure 2 and Table S).

= Chapter 13

EXERCISE B.4

Ce Piinn) (oP Gee) er

Multistage cluster sampling

Convenience sampling

Systematic sampling

Quota sampling Simple random sampling Purposive sampling

Consecutive sampling

EXERCISE C.1:

a. None of the studies used probability sampling.

Answers to Selected Resource Manual Exercises

b. Except for the study in Appendix C, all

Cc.

studies in the selected appendixes used convenience sampling. In Yackel and colleagues’ EBP study, the sample would best be described as a consecutive sam- ple: “All patients meeting the inclusion criteria were screened for depression...” Although Kim and colleagues described their sample as “purposive,” the descrip-

tion of the recruitment techniques

suggests that they used sampling by

convenience as well. None of the studies used quota sampling.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX F)

a. The target population in Eckhardt et

al.’s study could perhaps be described as community-dwelling patients with sta-

ble coronary heart disease (CHD) in the

United States (or in midwestern United

States). The accessible population was patients in cardiology clinics in the state of

Illinois.

The eligibility criteria for the study included (a) a diagnosis of stable CHD;

(b) the ability to speak and read English;

and (c) living independently. Exclusion criteria included (a) heart failure with

reduced ejection fraction (<40%); (b) ter-

minal illness with prediction of less than

6 months to live; (c) myocardial infarc-

tion or a CABG in the previous 2 months;

(d) unstable angina; (e) symptoms reflect-

ing worsening or exacerbation of cardiac disease; and (f) hemodialysis. The exclu-

sion criteria were intended to eliminate

patients with a recent acute event, those

with worsening symptoms, and those

with comorbid conditions associated with fatigue.

The sampling method was non-

probability, specifically, sampling by convenience. However, recruitment in

two sites serving different demographic populations greatly enhanced the

Generating and Assessing Evidence for Nursing Practice (11th ed.)

= APPENDIXP ® Answers to Selected Resource Manual Exercises 495

representativeness of the sample. One

clinic served primarily urban minority

patients with CHD, whereas the second clinic served Caucasian patients from a

more rural setting. The authors noted in

the discussion section that a possible lim- itation of the study was the use of a conve- nience sample.

d. Specific recruitment strategies were not

discussed in the paper (e.g., who did the recruiting, what prospective partici-

pants were told, how they were screened

for eligibility, what percentage of those approached actually participated).

e. The researchers increased the likelihood

that their sample would be diverse and more representative by recruiting from

two sites serving different demographic

and residential groups. In the section of the paper labeled “Strengths and limita-

tions,” the authors specifically noted that

“sampling an urban and rural population resulted in ethnic and geographic diver-

sity, thus increasing the generalizability of

findings.” f. The total sample size was 102

participants.

g. The report made no mention of having

performed a power analysis to estimate

sample size needs. No explanation was

provided regarding why a sample of 102 patients was selected, nor is sample size discussed in the discussion section of the report.

@ Chapter 14

EXERCISE B.2 Score of Y = 11; score of Z = 26

EXERCISE B.3

A = acquiescence; B = none; C = extreme

response set; D = naysayers’ bias

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX D)

a. Yes, there were self-reports in the Kim

et al. study, but they were not the pri- mary form of data collection. Self-reports were used to record dietary intake over a

3-day period, using a form that was not described in detail. It appears that the

dietary record was used as part of the

intervention—1.e., to provide individual

information about caloric intake and

other nutritional variables to program counselors. Data from the self-report

dietary record were also analyzed to compare nutritional intake before and after the program, as part of the assess-

ment of program effectiveness. The first paragraph in the section “Biochemistry

parameters” describes variables that were

extracted from the dietary record (e.g.,

fiber, calcium, vitamin C, total calories).

Self-reports were probably also used to obtain demographic information (marital

status, number of years living in the U.S.,

employment status), as well as some infor-

mation relevant to the process evaluation

(e.g., participant satisfaction), but again

no detail was provided. Given space con- straints in journals, it is understandable

that the authors could not devote much

space to describing how variables of lesser

importance to the research were captured. Specific questions from the self-report

instruments were not described in the

article. . No, there were no composite scales in this

study. . The dietary information was obtained

on a written record, and demographic

information was also probably obtained

in writing. Process evaluation informa- tion (e.g., participant satisfaction) may

have been gathered in interviews, but the

report did not state how these data were

gathered. . No, the report did not mention the read-

ability level of self-report instruments.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

496 APPENDIXP

f. No, observational data (e.g., observations

of actual eating or meal planning) were

not gathered. g. The outcome variables for this pilot inter-

vention study were biomarkers. The pri-

mary outcomes were daytime ambulatory

systolic and diastolic blood pressures—in vivo measures. Urine and blood tests (in

vitro) yielded data on many other outcomes

(e.g., cholesterol, potassium, ascorbic acid).

h. Yes, the report provided considerable infor-

mation regarding how the biophysiologic

measurements were made and standardized,

in the subsection labeled “Measurement.” i. The article stated that trained research

staff explained the study to participants.

No further information was provided about training for data collection, but this

is not unusual.

@ Chapter 15

B. STUDY QUESTIONS

B. 1. Only one of the measures listed—(c) the

10-item scale to measure resilience—could

be assessed for internal consistency. Internal

consistency is only relevant for multi-item

reflective scales.

B.4

a. High reliability of an instrument is nec-

essary for strong validity, but it does not guarantee it.

b. The internal consistency of an instrument

does not address whether it yields stable measurements over time.

c. Adequate validity of a measure does not ensure good responsiveness. For example, if change scores are unreliable, responsive-

ness would be compromised.

d. A true score can never be known. A reli-

ability coefficient provides information about how good an approximation a set

of obtained scores will be, on average, in

representing true scores, but an individual

true score cannot be inferred.

Answers to Selected Resource Manual Exercises

e. Validation efforts lend evidence in support of an inference of construct validity, but

no amount of evidence proves construct

validity. f, Expert opinions yield one type of evidence

about the validity of a measure, but one person’s opinion would never yield suffi-

cient assurance.

g. Coefficient alpha does not provide an esti-

mate of interrater reliability.

Bee

a. The 15-item scale would likely be more

internally consistent than an 8-item scale;

longer scales are usually more internally

consistent than shorter ones.

b. Stress would likely be more uniformly high among patients just diagnosed with

cancer; the higher similarity of these scores

would tend to depress reliability because it would be harder to reliably discriminate among people with high levels of stress.

c. Nursing knowledge would probably be more varied among seniors (some of

whom have mastered nursing content and

others of whom have not) than among freshmen. Therefore, reliability would

be expected to be higher among senior

students.

EXERCISE C: QUESTIONS OF FACT (APPENDIX A)

a. (1) None of Nyamathi et al.’s data were

extracted from records; (2) Self-reports

were used to measure almost all the variables used in the analyses, including information about demographic and

background characteristics, psychosocial variables, incarceration history, and use

of drugs (3) structured observations were

used to assess intervention fidelity; (4) A

urine test was used to corroborate self- reported use of drugs.

b. The researchers did not specifically men-

tion test-retest reliability information for any of the self-report scales selected for

Generating and Assessing Evidence for Nursing Practice (11th ed.)

r APPENDIXP ® Answers to Selected Resource Manual Exercises 497

use in the study. It is possible, however,

that test-retest reliability information was

available for some of the measures, but

not specifically highlighted. For example, the authors noted that, for the Mental

Health Index, “reliability estimates from .74 to .85 were reported among homeless and drug-using samples” and it is possible

that the reliabilities reported were for test- retest estimates.

. Internal consistency was reported for

many of the self-report measures used in this study. In most cases, the estimate of

coefficient alpha was from a different sam-

ple, such as the sample used in developing the scale. For example, social support was measured using the Medical Outcomes

Study Social Support Survey, which had

a Cronbach alpha value of .97 in the development sample. For some measures, alpha was computed using data from the research sample. For example, the alpha for the Mental Health Index was .87 in the research sample. There were a few measures for which reliability information

was not provided-for example, for the

8-item scale for treatment readiness.

. The report did not mention or provide

any information about the validity of the measures used in this study. However,

by looking at the reference list for the citations used for the measures, it can

be seen that most of the measures were

subjected to validation procedures. Journal page constraints, and the large

number of instruments used in this study, likely limited the amount of detail the researchers could provide about their

measures. . No measurement properties were reported

for the urine analysis, which is not unusual—such measures are typically assumed to yield high quality data.

. No mention was made regarding measure-

ment error for any of the instruments—

but this is not unusual. . No information about the reliability of change scores or responsiveness of the

measures used in this study was provided.

These two measurement properties are seldom discussed in nursing research papers. And, in this study, only changes in

drug and alcohol use from baseline to the

6-month point were used in the analysis

(i.e., not changes in depression or social

support scores). Self-reported drug use was validated against the urine analysis data.

= Chapter 16

EXERCISE C: QUESTIONS OF FACT (APPENDIX J)

a. Caruso and her colleagues did not start “from scratch” in developing a scale.

In the section of their report labeled “Previous Measures,” they described other

efforts to measure worry about breast can-

cer, most notably the Cancer Worry Scale

(CWS). They acknowledged that the CWS

has been found to have good internal con- sistency and has been used (and adapted) in diverse applications. Their specific goal

was to adapt an instrument that would measure cancer worry within the con-

text of genetic counseling in Italy. They also noted that, although the CWS has been treated as unidimensional, the scale

includes items that they believed tapped a different dimension—risk perception (RP). They explained how CW and RP differ, and sought to measure these dimensions

separately.

b. The authors stated that they developed a

pool of items, using items from existing

tools, including the CWS. The items were translated (presumably from English into Italian) and then back-translated. A rec-

onciliation process was used to finalize the

wording of items in Italian. c. The report did not state the size of their

“item pool.” Nothing was said about items being eliminated as a result of a pilot test or a content validation, and so it seems likely that the initial item pool is the

Generating and Assessing Evidence for Nursing Practice (11th ed.)

498 APPENDIXP ® Answers to Selected Resource Manual Exercises

i. For the main analyses, patients were same as the number of items on the scale,

which was 7. Six of the 7 items were from

the original CWS and 1 item was from a different existing scale.

. Two different response option types were used. The five items tapping the “cancer worry” component were measured on a

5-point scale, from 0 (“not at all/never”)

to 4 (“very much/very often”). The two items measuring risk perception were on

a 0-100 rating scale, analogous to a visual

analog scale (perceived likelihood of get- ting breast cancer or having a gene that predisposes women to breast cancer, from 0% to 100%).

. Higher scores on the two subscales repre-

sent higher amounts of cancer worry and

greater perceived risk of cancer. . There was no information about a formal

readability assessment—although the report indicated (under “Participants” )

that one of the purposes of the pilot study

was to ensure readability. The researchers

also deliberately sought participants who

read at or lower than the 8th grade read- ing level, so readability was clearly one of their concerns.

. The authors undertook a pilot study in which the instrument was pretested. The

report indicated that participants in the

pilot (25 women aged 45 to 75 from two sites) completed a questionnaire and were asked to provide feedback about the clarity of each item. Most pilot participants were

able to complete the questionnaire in less

than 15 minutes—time-to-complete is use-

ful information to have about a new scale,

especially one that might be administered in clinical settings. About one-third of the sample found one item difficult to under- stand, and it was reworded. The research-

ers found limited evidence of an extreme

response set (two participants). No mention

was made of cognitive questioning.

Content validity apparently was not assessed. Given that the items were

from previous scales, this is perhaps not surprising.

recruited from 7 cancer genetic clinics. Eligible participants were women 18 years

of age or older who had a first-degree rela- tive with breast or ovarian cancer. A total

of 304 women aged from 23 to 83 partic- ipated in the main study. The sample was

heterogeneous with regard to educational

backgrounds. j. Yes, the report indicated that the corrected

item-total correlations ranged from .50 to

.72 (in the section labeled “Validity and

Internal Consistency”). . Yes, internal consistency of the 5-item CW

subscale, as assessed using Cronbach’s alpha, was .90, and it was .70 for the

2-item RP subscale.

. The test-retest reliability of the scale was assessed using a subsample of 50 women. The retest sample represented 10 randomly

selected women from the main sample in 5 of the 7 cancer genetic clinics. The CWS-GC

was re-administered to these 50 women 4

weeks after the initial administration. The

researchers reported that the intraclass cor- relation coefficient (ICC) was calculated,

which is the appropriate retest reliability coefficient. The ICCs were .87 for the CW subscale and .70 for the RP subscale.

. There was no mention of an exploratory factor analysis, but a confirmatory factor analysis was undertaken. The CFA sug- gested that a two-factor solution was appro- priate. The researchers also tested 1-factor and 3-factor solutions but found the results of the 2-factor model more suitable. Since CFA is used to test explicit hypotheses about factor structure (dimensionality of a set of

items), it is unusual to tests multiple models. . It does not appear that cross-cultural

validity was assessed. The researchers took appropriate steps to translate the original CWS scale into Italian (e.g., with back

translations), but no mention was made of

efforts to assess the equivalence of the orig- inal and translated scale. It is, of course,

possible that a cross-cultural validation was undertaken but not reported in this paper.

- APPENDIX P #

o. The authors undertook several validation

activities. For example, they examined

the correlations between scores on the CWS-GC scale and scores on several

other measures that they hypothesized would be related. These included the State-Trait Anxiety Inventory (STAI) and

three subscales of the Cognitive Behavioral Assessment Form that measured general anxiety, fear reactions in the context of

health care, and depression. The research- ers described their efforts as assessing the “criterion validity” of the CWS-GC, but

we would argue that they were assessing

convergent validity, which is a type of

construct validity. The four scales used in their validation were not “gold standard”

measures of cancer worry or risk percep- tion. They were, however, good choices

for assessing the convergence of constructs hypothesized to be conceptually related.

Both subscales of the CWS-GC correlated with the four validation measures at sta- tistically significant levels. Known-groups validity was also assessed by comparing CWS-GC scores for women with ver- sus without current cancer symptoms. The researchers “expected” that women

who had experienced cancer symptoms would have higher cancer worry and higher perceived risk than asymptomatic

women. The findings indicated that the groups differed on the RP but not the CW subscales, but in the opposite direction: asymptomatic women had significantly

higher RP scores than women with cancer

symptoms. The authors did note in the “Study Design” section that the oppo-

site hypothesis was also suggested in the literature: “we expected that potentially

asymptomatic mutation carriers perceived

less controllability of their condition than women with manifest disease and then

reported a lower RP.” . The researchers did assess their scale for

responsiveness. They hypothesized that women would have lower cancer worry

one month after a genetic counseling

Answers to Selected Resource Manual Exercises 499

information session. Using the 50 women

in the retest sample, the researchers tested

whether the women’s scores were signifi-

cantly lower at the follow-up measurement. Their hypotheses about changes in scores

(longitudinal validity) were supported.

As shown in their Table 4, CW subscale

scores were significantly lower at follow-up for both symptomatic and asymptomatic women. RP subscale scores were signifi-

cantly lower for the overall sample, but not for symptomatic women. It should be

noted that the researchers would likely have had better results on their retest reliability assessment if they had obtained the second measurements at, say, 2 weeks

after the original testing rather than 4 weeks. The fact that significant change was detected at 4 weeks means that the trait was not stable, which is the desirable situa-

tion for retest reliability assessments.

@ Chapter 17

EXERCISE B.1

SM mo O20 F

Interval

Ordinal

Ratio

Nominal

Ratio

Interval

Nominal

Interval

Ratio

EXERCISE B.2

Unimodal, fairly symmetric

EXERCISE B.3

Mean = 81.8; median = 83; mode = 84

Generating and Assessing Evidence for Nursing Practice (11th ed.)

500 APPENDIXP

EXERCISE B.4

Overall, 23.3% of the sample (28/120) were

lactose intolerant. This included 20.0% of the

boys (20/60) and 26.7% of the girls (16/60);

57.1% of the children who were lactose intol-

erant were female.

EXERCISE B.7

Absolute Risk, exposed group (ARg) = .60;

Absolute Risk, non-exposed group (ARwg) =.90; Absolute Risk Reduction (ARR) = .30;

Relative Risk (RR) = .667; Relative Risk

Reduction (RRR) = .333; Odds Ratio (OR) =

.167; Number Needed to Treat (NNT) = 3.33

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX F)

a. Yes, Eckhardt and her colleagues presented

descriptive statistics about the demographic and clinical characteristics of their study participants, both in Table 1 and in the text. For example, the text provided descriptive

statistics regarding participants’ age: “The

mean age of participants (N = 102) was 65

years (SD = 11 years, range = 34-86 years).

b. Referring to Table 1:

¢ Nominal-level: Gender, race/ethnicity,

marital status, employment status, pres- ence of comorbid condition, and types of medications taken; Ordinal-level: As

operationalized in this paper, educa-

tion was measured on an ordinal scale;

Interval-level: None; Ratio-level: None.

Education could have been measured on a ratio scale: number of years of

schooling completed. However, ordinal

categories such as the ones used actu- ally are more informative than present- ing mean years of schooling completed.

e The typical study participant was a white (non-Hispanic) male who was

married and retired, with at least 12

years of education.

¢ 12.7% of the sample had a graduate degree.

Answers to Selected Resource Manual Exercises

c. Referring to Table 2:

e This table presented Pearson’s correla- tion coefficients (rs) between fatigue intensity and fatigue interference on the one hand, and 12 other variables on the

other. ¢ The variable that was most strongly

correlated with fatigue intensity scores was depressive symptoms, as measured using the Patient Health Questionnaire-9 (PHQ-9). The correla-

tion coefficient was .56, which is fairly

substantial. e The correlation between education

and fatigue intensity was -.16. This indicates that people who had more

education were slightly less likely to have high fatigue intensity scores than

those with less education.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX H)

a. Yes, Wilson and her colleagues presented

descriptive statistics about the baseline

characteristics of their sample members.

Table 2 presented the sample’s demo- graphic characteristics, separately for par-

ticipants in the intervention and control

group (“standard care”). In both groups, there was a higher percentage of women than men; about one-third of the sample

had less than a high school diploma; a relatively small percentage were living alone; most were on some form of pain medication and the vast majority had a

preoperative diagnosis of osteoarthritis.

The text also presented information about the participants’ age: the mean was 67 + 8

years in the intervention group and 66 + 8

years in the standard care group. b. Referring to Tables 2 through 5S:

¢ Nominal-level: Sex, home status, use

of pain medication; and preoperative diagnosis. Ordinal-level: As operational- ized, highest education level was on an

ordinal scale; Interval-level: All of the

Generating and Assessing Evidence for Nursing Practice (11th ed.)

cs APPENDIXP &

pain interference scale scores in Table 3, and pain levels in Table 4; Ratio-level: amount of opioids administered, in mil- ligrams of total morphine equivalents.

¢ The total sample size was 143 study

participants: 73 in the intervention

group and 70 in the standard care group. There was some missing data for some of the tables, however.

e The tables included the following descriptive statistics: percentages,

means, standard deviations, medians,

and interquartile ranges.

¢ The mean pain score on postoperative

day 3 for the variable “Worst pain in last 24 hours” was 7.0 (on a scale from

0 to 10) for both groups. ¢ The median amount of opioid analgesics

administered on the first postoperative day was 78 milligrams in both groups.

= Chapter 18

EXERCISE B.3

ZO ee

Chi-square test t-test for independent samples Pearson’s r

ANOVA

EXERCISE B.4

ay b: Cc.

893

-.134

Yes, it is significant at p < .001; in SPSS, any probability value

less than .001 (e.g., .0003 or .00009) is

shown as .000. d. p < .001 e. Number of

doctor visits and the SF-12 physical health scores; for the mental health scores, p was

greater than .01, but the correlation was

still significant at conventional levels f. The correlation between the two scales (ry = .168) is fairly modest. The coefficient

indicates that there is a slight tendency for people who are in better physical health

Answers to Selected Resource Manual Exercises 501

to be in better mental health. The modest

correlation is highly significant because of the large sample size.

EXERCISE B.6

a. 344 in total, 172 per group b. 194

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

a. The report made no mention of using a

power analysis to estimate sample size

needs—but this does not mean that the researchers did not do a power analysis.

. The baseline demographic and psychoso-

cial characteristics of the two groups were presented in Table 1. The descriptive sta- tistics presented in this table were means, standard deviations, and percentages. The researchers did perform statistical tests to

assess the comparability of the two groups

with regard to all of the variables in the table, as noted in the footnote to the table.

Because many of the variables were not

normally distributed, the researchers opted to use Wilcoxon rank-sum test rather than t-tests for testing differences on continu- ous variables, as described in the section

labeled “Data Analysis.” The chi-square

test or the Fisher exact test was used for testing differences in proportions. The

statistics themselves were not reported.

The footnote to Table 1 indicates that all p values were nonsignificant, i.e., p > .0S.

. Attrition in this study was low—among

the 130 women who were randomized (65 per group), only 14 were not in the

final analysis sample. It does not appear

that the researchers undertook an analysis

of attrition bias (i.e., comparing baseline

characteristics of people in versus not in

the final sample—or, at least, they did not

report the results of such an analysis. . Table 2 shows the percentage abstinent

at baseline and at the 6-month follow-up

Generating and Assessing Evidence for Nursing Practice (11th ed.)

502 APPENDIXP =

for both groups. For example, in the

dialectical behavioral therapy-case man-

agement (DBT-CM) group, the percentage

abstinent for drugs changed from 27.6%

at baseline to 65.5% at follow-up. For the health promotion (HP) group, the change

was from 32.8% at baseline to 48.3% at follow-up. The statistical analysis the

researchers used did test for the signifi- cance of the within-group changes, but the

results of these tests were not reported.

. Yes, between-group results were reported

in both Tables 2 and 3. In Table 2, the

table title indicates that the between- group interaction (the interaction between group and the time of measurement) was

tested using logistic regression. This is a

multivariate procedure that is discussed

in the next chapter. However, we can see

in Table 2 that the group differences were statistically significant for abstinence from drugs (p = .04) and abstinence from alco-

hol (p = .02), but missed being statistically

significant for any substance (p = .07).

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX D)

a. In Table 4, the researchers reported the

results of paired t-tests and repeated mea- sures ANOVA. The t-tests were used when

measurements were made only twice, and

RM-ANOVA was used for outcomes that

were measured 3 times.

. The independent variable in the analy- ses presented in Table 4 was treatment exposure, as captured by the time of the

measurement. At 0 weeks (baseline), the

participants had not been exposed to dietary intervention, but at 4 weeks and

10 weeks, they had been. The dependent variables were the various biomarkers

measured in the fasting blood tests (cho- lesterol, etc.).

. The purpose of the tests presented in Table 4 was to test the hypotheses that the dietary intervention would have beneficial effects on blood chemistry outcomes.

Answers to Selected Resource Manual Exercises

No, actual values of F (for the RM-

ANOVA) and t (for the t-tests) were not

presented. Although it is customary to do so, the actual values typically are not of inherent interest to readers.

. Using the convention of p < .05, there were significant changes over time for 5 outcomes: HDL-cholesterol (p =.034);

LDL cholesterol (p =.047); K (p =.040);

ascorbic acid (p =.008); and Urine P

(p =.025). The test for total cholesterol

missed being significant at conventional

level (p =.056), likely reflecting the small

sample size (N = 28).

. No, a power analysis was not per-

formed—it is rare to do a power analysis

for a pilot study. The ES for ascorbic acid would be .67—a fairly large effect size [(0.8 — 0.6) + 0.3 =

ren

@ Chapter 19

EXERCISE B.2

oanqT®

. Logistic regression

. ANCOVA

MANOVA

. Multiple regression

. Mixed design RM-ANOVA

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

Yes, the researchers used multivariate

logistic regression in this study.

The primary dependent variable was a dichotomous variable, whether the study participant was drug abstinent since

baseline (coded 1 = abstinent and 0 = not

abstinent). The secondary outcomes were

alcohol abstinence and substance absti- nence, i.e., both drug and alcohol absti- nent. In the main analysis, the independent variable was whether the participant was in the Dialectical Behavioral Therapy-Case

Generating and Assessing Evidence for Nursing Practice (11th ed.)

S APPENDIX P = Answers to Selected Resource Manual Exercises 503

Management (DBT-CM) program or

the Health Promotion (HP) program. Specifically, the three independent vari- ables were program, time, and Program x

Time interaction. As the researchers noted

in their Data Analysis section, “The coef- ficient for the Program x Time interaction corresponds to the difference in change in abstinence among DBT participants com-

pared to the change in abstinence observed among HP participants”. In addition, the researchers undertook a logistic regression

analysis in which the primary outcome

(drug abstinence) was predicted on the basis of several variables known to be related to drug use. These predictors,

shown in Table 3, included the partici-

pants’ baseline drug use, race, impulse

control difficulties, and scores on several

indicators of mental health. . As noted in the last paragraph of the Data

Analysis section, the researchers used a

stepwise approach to entering predictors

into the logistic regression model.

. Table 2 shows that group differences

favored the DBT-CM participants for

drug abstinence, alcohol abstinence, and

substance abstinence. However, at conven-

tional levels for statistical significance, the group difference for substance abstinence

was not significant (p = .07). . In Table 3, we can see that scores on the

Mental Health Index was a significant pre-

dictor of drug use abstinence in bivariate analyses (p = .02). However, the researchers

used stepwise entry of predictors in the multivariate analysis, and the Mental Health

Index did not make it into the model. This almost certainly reflects the fact that scores

on this index were correlated with other variables already in the analysis, such as scores on the CES-D depression scale.

b. The researchers conducted 4 separate

multiple regression analyses: two with

fatigue intensity scores as the outcomes (we will refer to them as Models Al

and A2), and two with fatigue interfer- ence as the outcomes (Models B1 and

B2). The results were presented in two

separate tables, Tables 3 and 4. In the “1” models, the independent variables were those that correlated significantly with the outcome in bivariate analyses:

gender, income, history of smoking, and

depression scores in model A1, and gen-

der, age, and depression scores in model

B1. In the “2” models, the independent variables were ones that were hypothe-

sized to be predictors of the outcomes, based on the researchers’ conceptual framework. The A2 and B2 models used gender, age, and depression scores as predictors.

. It appears that in all four regression analyses, all predictors were entered simultaneously.

. In all four models, only the depression

scores were statistically significant, once

the other predictors were statistically

controlled. . For the two fatigue intensity analyses,

the unadjusted value of R* was .32, in

both cases highly significant. For model

A1, F (2, 99) = 22.92, p < .0001, and for model A2, F (2, 96) = 15.20, p < .0001. For the fatigue interference analyses, the

unadjusted values of R* was .43 and .35, for models B1 and B2, respectively. Again,

both were highly significant, p < .0001. (This information was shown as a foot-

note in Tables 3 and 4.)

. The table does not provide all elements of the regression equation for predicting new values of the dependent variable from raw scores. Although values for 0 for all predictors are shown, the value of the con-

stant (a) is not reported. EXERCISE C.2: QUESTIONS OF FACT (APPENDIX F) g. No mention was made in the report about

assessing multicollinearity. That does not

mean that such an assessment was not

undertaken. a. Eckhardt and colleagues used multiple

regression analysis in this study.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

504 APPENDIXP &

= Chapter 20

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

a. In the last paragraph in the subsection

labeled “Data Analysis” in the Methods

section, the researchers stated that they

used the statistical software packages called R, version 3.3.0.

. The report indicated that tests were per-

formed to assess the degree to which their

data met assumptions for parametric tests. In the first paragraph of the subsection

labeled “Data Analysis,” the researchers noted that the Wilcoxon rank-sum test was

used in lieu of t-tests “because many of the

variables were not normally distributed.”

. Yes, as shown in their supplementary flow

diagram Figure, a total of 130 women were

randomized to one of the intervention pro-

grams—6S per group. The final analysis sample was 116 women, 58 per group.

This represents an attrition rate of 10.7%.

. There was considerable information about

how missing data were handled. The primary analysis was a “complete case”

analysis for the 116 women for whom

they had 6-month follow-up data. The researchers also analyzed their data using an intention-to-treat approach, and they

used two methods of imputation. The first was the Last Observation Carried Forward

(LOCF) approach, in which the baseline

information for drug and alcohol use was

used—that is, the analysis involved the

conservative assumption that none of the

women improved. The second approach

was the multiple imputation approach.

The article did not specifically use the term

“intention-to-treat” analysis, but that is

what they used in their sensitivity analyses. Yes, the researchers carried out three

separate types of sensitivity analysis and compared the results to the results from the main analysis: (1) a per-protocol analysis in which only the women who

completed all of the program activities; (2)

Answers to Selected Resource Manual Exercises

an intention-to-treat analysis with LOCF

imputation; and (3) an intention-to-treat

analysis with multiple imputation.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX F)

a. Yes, the report stated that data were ana- lyzed using the Statistical Package for the

Social Sciences (SPSS), version 19.

. No, the report did not state whether tests

were performed to assess the degree to which their data met assumptions for

parametric tests. The absence of any state- ment does not mean that the researchers

failed to make such assessments.

. No, the report did not provide any infor-

mation about missingness. Readers can

sometimes make inferences about missing

information by looking at sample size

information in the tables—for example, to see if the Ns vary from one analysis to

another. However, the researchers in this

study did not provide sample size informa-

tion in their tables.

The report did not specifically mention transformations.

. No sensitivity analyses were mentioned.

= Chapter 21

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

a. Baseline values on key demographic and background variables were presented in Table 1 for both groups. A footnote at the bottom of the table indicated that none of the group differences was statistically sig- nificant. Also, we can see from the graphs in Figure 1 that the two groups were com-

parable on all three outcomes at baseline, as mentioned in the text. For example, for

the primary outcome of drug use in the

prior 6 months, 67.7% of the women in

the Dialectical Behavioral Therapy-Case

Generating and Assessing Evidence for Nursing Practice (11th ed.)

= APPENDIXP ® Answers to Selected Resource Manual Exercises 505

Management (DBT-CM) group and 69/2% of those in the Health Promotion (HP) group had used drugs at baseline (NS).

. There was some modest attrition in both groups. The flow diagram shown in the

supplementary Figure indicates that the

main analysis was completed for 58 of the 65 women randomly assigned to both groups (116 of the original 130), an attrition rate of 10.7%. The research-

ers did not report an explicit attrition

bias analysis comparing completers to non-completers (although they may have undertaken such an analysis). However,

the graphs in Figure 1 show that there were slight differences in the baseline

abstinence rates of those in the main analysis sample (32.8% in the HP group

and 27.6% in the DBT-CM group) and

those in the full baseline sample, shown

in the last row of the graph (30.8% in

the HP group and 32.3% in the DBT-CM group). This suggests a modest attrition

bias, with slightly higher rates of drug abstinence among those who were not included in the main analysis in the HP

group. . The researchers formally stated their

hypothesis in the section labeled “Purpose”: “We hypothesize that DBT-CM will increase the odds of absti- nence to drug use during the 6-month study period compared to the HP pro-

gram.” In the main analyses, the results

indicated that abstinence rates were

significantly higher for those in the DBT-CM group for drug use (p = .04) and for alcohol use (p = .02), but not for

drug and alcohol use (p = .07). However,

these results were modified in the sensi- tivity analyses. When multiple imputa- tion was used to impute outcome values for those whose outcome data were not

available, the results were not statisti-

cally significant (p = .26 for drug use abstinence)—although the results were significant when the imputation method was last observation carried forward

(p = .0S for drug use abstinence). In a

logistic regression analysis that involved

multiple predictors of abstinence (i.e., controlling for such factors as race,

depression, and baseline drug use, as

shown in Table 3), the adjusted OR for

abstinence in the DBT-CM group was 3.15, p = .01. This OR represents the

difference in change of abstinence from baseline to follow-up in the DBT-CM

group, i.e., that with other significant predictors of drug use controlled, they were three times more likely to abstain

from drugs at follow-up than the women in the HP group. Thus, although the evi-

dence is somewhat mixed, the weight of

evidence does suggest that participation

in the DBT-CM group contributed to decisions to abstain from drugs.

. Yes, Table 3 shows the 95% CIs around the

values of the adjusted odds ratios. The OR

for abstaining for those participating in the

DBT-CM group was 3.15, and the 95% CI around this value was from 1.30 to 7.69.

. With logistic regression, the values of the

odds ratios are often interpreted as effect size indexes, and these were reported by

the researchers. . There was no explicit discussion about

internal validity in the Discussion section.

. Yes, the researchers explicitly noted that “Our findings may not be generalizable

across other parts of the United States,”

i.e., other than California.

. Yes, the researchers emphasized that the results were encouraging and that “integration of this intervention at RDT (residential drug treatment) sites should be further tested in a larger-scale trial.”

i. Yes, limitations of the study were dis-

cussed in a section labeled “Limitations”.

The authors noted concerns about gen-

eralizability and noted that “A larger

randomized controlled trial is needed to

validate our findings and generate more robust estimates of the effect of DBT-CM

on drug and alcohol use.”

j. The authors did not make any mention of

clinical significance in their report.

Generating and Assessing Evidence for Nursing Practice (1 1th ed.)

506 APPENDIXP &

#@ Chapter 22

EXERCISE B.1

(eS

Grounded theory

Ethnography

Phenomenology

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX E)

a. The study by Cummings was a phenom-

enologic study, based in the interpretive

phenomenologic school of inquiry. The central phenomenon of this study was the experience of listeners and storytellers when a traumatic event is being communi-

cated within the dyad. . This study was not longitudinal.

Interviews were conducted at a single

point in time with the storytellers and the listeners.

The context for the study was the crash-

landing of U.S. Airways Flight 1549 in the

Hudson River on January 15, 2009. The

researcher conducted interviews with 12

people who were on the flight (storytell-

ers) and 12 friends or family members to

whom they told their stories, mostly face-

to-face. The settings and locations of the interviews were not described.

. Even though the study involved two groups of people, storytellers and listen- ers, the focus was not on comparing their experiences—the focus was on the sharing of a traumatic event.

The in-depth interviewing methods used in this study were well-suited to answering

the research questions and were congruent

with interpretive phenomenology. The

researcher noted that she reached satu- ration (obtained redundant information)

after interviewing 9 dyads, but interviews

with an additional 3 dyads helped to con- firm saturation.

No, there was no ideological perspective in this study.

Answers to Selected Resource Manual Exercises

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX G)

The research by Byrne and colleagues was

a grounded theory study. The researchers used Charmaz’s approach to grounded theory, a constructivist

approach, as described in the first para- graph under “Methodology.” They cited

two of Glaser’s writings in the section on

data analysis. The central phenomenon studied in this project was the care transition experiences

of spousal caregivers, when their spouses moved from a geriatric rehabilitation unit

to home. Yes, the study was longitudinal. Byrne

and colleagues collected data from most study participants (15 out of 18) at mul-

tiple points in time to better understand

the transition experience. The intent was

to interview participants three times: 48

hours after discharge from the geriatric unit, 2 weeks after discharge, and 4-6

weeks after discharge.

This study was conducted in Ontario,

Canada. Families were recruited through a long-term care hospital. Data were col-

lected in the participants’ homes. Yes, in the analysis subsection the

researchers stated that they used “the

constant comparative method with all

units of data.” They also elaborated: “Constant comparison entailed compar-

ing incident to incident and comparing incidents over time between and within participants.”

Yes, Byrne and colleagues identified the basic social process as reconciling in response to fluctuating needs. (The authors did not, however, identify the

basic problem that caregivers experience during the spouses’ transition from the geriatric rehabilitation unit to home). The methods used in this study were congruent with a grounded theory

approach. The researchers conducted

lengthy conversational interviews at mul-

tiple points in time with 18 caregivers

Generating and Assessing Evidence for Nursing Practice (11th ed.)

F APPENDIX P @

whose spouse was transitioning from a

geriatric rehabilitation unit. In addition,

the researchers made observations of the interactions between the spouses and care recipients prior to, during, and after

the interviews. As noted previously, con-

stant comparison was used in analyzing the rich data.

. No, this study did not have an ideologic

(e.g., a feminist) perspective. Even if all

study participants had been female (which they were not), gender was not a key con-

struct in helping the researchers interpret

the data—although the authors did discuss gender differences in the discussion section of their paper.

#@ Chapter 23

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX B)

a. Specific eligibility criteria were not stated in this report. All study participants were nurses who worked “in a level-I[V NICU in a free standing, children’s hospital in the northeastern United States.”

. The article stated that study information

was provided to the nurses though staff

meetings, the hospital’s intranet, and

individual encounters in the NICU. The

article did not discuss specific recruitment

procedures.

. The article indicated that there were both

“general informants” who were selected to provide a broad overview of beliefs and

practices,on the unit, and key informants who were followed more closely through

observation and interviews. The research- ers indicated that both key and general informants were selected purposively “for

a maximal variety of infant feeding beliefs

and practices.” The sample included 114 nurses who were

general informants, out of 250 nurses employed in the NICU. From this general sample, 18 key informants were chosen

Answers to Selected Resource Manual Exercises 507

who were followed more intensively and

interviewed in-depth. They were identified

through observations as being knowledge-

able and articulate about varied feeding beliefs and practices.

The article stated that the data were “robustly saturated” after repeated inter- views and observations.

The article described background charac- teristics of the nurses in the sample. For

example, of the 114 general informants,

96 were white, and all but one was female.

Among the 18 key informants, the mean age was 33, with a range between 22 and 51

years of age. There was diversity among the key informants in terms of education (from

diploma to a master’s degree) and level of expertise, from novice to clinical expert.

About half of the key informants had taken

the hospital’s breastfeeding course.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX G)

a. The article stated that the spousal care-

givers (the study participants) had to be returning home from the geriatric rehabil-

itation unit (GRU) with a husband or wife

who did not have cognitive impairment or

dementia. . Participants were recruited at the long-

term care hospital through a GRU team member who was not affiliated with the

study. Then, those who were willing to participate were approached by Byrne.

. The researchers referred to “initial” sam-

pling (presumably convenience sampling)

and theoretical sampling that was used to guide data collection. Byrne and col- leagues provided the readers with a spe-

cific example of their theoretical sampling

having to do with how and when caregiv-

ers shifted the boundaries. . The sample consisted of 18 caregivers, 9

men and 9 women.

. The report mentioned theoretical satura- tion of categories. The authors noted that

“In accordance with theoretical sampling,

Generating and Assessing Evidence for Nursing Practice (11th ed.)

508 APPENDIXP #

the categories noted to be relevant to the

development of the emerging theoretical

framework guided the sampling process

rather than particular sample characteris- tics such as demographics.”

. There is no mention of sampling confirm-

ing or disconfirming cases.

Characteristics of the 18 couples were briefly described. The caregivers mean age was 77.4 years, and they had been mar-

ried, on average, for 47 years. Care recip-

ients, who tended to be slightly older than the caregivers, had had an average léngth

of stay on the GRU of 41 days.

@ Chapter 24

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX B)

a. Yes, Cricco-Lizza’s study involved in-

depth interviews with the 18 key infor-

mants, who were nurses working in the NICU. In addition to formal interviews,

the key informants (as well as general

informants) were informally interviewed

several times (between 3 and 43 times)

over the course of the study. The nurses

were asked about their nursing care relat-

ing to infant feeding.

. The formal interviews involved “open-

ended questions,” which likely means

that a semi-structured approach was

used—that is, the interviewer asked a set

of open-ended questions that she had in

mind at the outset. It seems likely that for

the informal interviews, an unstructured

format was used—that is, questioning was

probably more ad hoc and conversational,

and was triggered by an event or activity

that the researcher had observed.

. The article said that, in the formal inter-

views, the nurses were asked to describe

their work days and their specific respon-

sibilities for infant feeding. It also stated

that the open-ended questions asked

about breastfeeding, formula feeding, and

Answers to Selected Resource Manual Exercises

the nature of their nursing care. In inter- views that occurred after observations,

the nurses were asked to explain any

issues that arose during the observation

session.

The article stated that the formal inter- views lasted one hour. The interviews were audio recorded and

subsequently transcribed verbatim. The

report indicates that the transcripts were

scrutinized for accuracy. Yes, participant observation was an import-

ant source of data in this study. There was

a total of 128 observation sessions. The observations focused on the nurses “during their interactions with babies, families,

nurses, and other staff throughout their

varied activities in the unit.” Examples of

activities observed included infant feedings,

nursing care, shift reports, committee meet-

ings, and nurse-run breastfeeding support

group meetings for parents. The article stated that the observational data and data from informal interviews after the observations “were documented

in detailed field notes immediately after

each session.”

Cricco-Lizza herself collected the study data. The article stated that “the sole

investigator introduced herself as a nurse researcher” and that her role “varied from observation to informal interviewing.”

The full nature of her participation was not described.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX G)

a. Yes, self-reports were the primary form of data collection in this grounded theory study. The questions focused on “sensitiz-

ing concepts” from prior related research

(e.g., changes in the relationship since

returning home, social supports available). In-depth face-to-face interviews in the

geriatric rehabilitation unit (GRU) and in

participants’ homes were used to collect

self-report data. The goal was to conduct

Generating and Assessing Evidence for Nursing Practice (11th ed.)

cs APPENDIX P @

interviews longitudinally, at three points

in time (48 hours prior to discharge from the GRU, 2 weeks post-discharge, and 4-6

weeks post-discharge). However, not all

participants were able to adhere to this schedule. Fifteen of the 18 original sample

members were interviewed at least twice.

. The researchers gave examples of a couple of questions: “Participants were asked

how they would describe their relation-

ship with their spouse currently...in com-

parison to before they were admitted to the GRU, and about who had been espe-

cially helpful to them in caring for their spouse.”

. Interviews lasted between 35 and 120 minutes. Among the 15 caregivers who

were interviewed more than once, the total

interview time per participant was 1.5 to 5

hours.

. All interviews were digitally audio-

recorded and transcribed verbatim by an experienced transcriptionist.

. Yes, the researcher also observed and

recorded interactions between the spouses.

The report noted that the researcher (the first author) was “finely tuned in” to look

for interactions that would help elucidate processes and categories emerging from

the data.” . Observations were recorded in a field

notebook. . The observations were unstructured (i.e.,

a priori categories for recording observa- tions were not established), and specific

observation times were not established

beforehand. However, the observational

method would not be described as partici-

pant observation—nor did the researchers

describe it as such.

# Chapter 25

EXERCISE B.3

a. A grounded theory analysis does not yield

themes.

Answers to Selected Resource Manual Exercises 509

Texts from poetry are used by interpretive phenomenologists, not by ethnographers

(unless the poetry is a product of the culture

under study, which it is not in this case).

Phenomenologic studies do not focus on

domains, ethnographies do.

Grounded theory studies do not yield tax-

onomies, ethnographies do.

A paradigm case is a strategy in a herme-

neutic analysis, not in an ethnographic one.

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX E)

a. Yes, Cummings’ interviews were recorded

and transcribed verbatim by a transcrip- tionist who had completed special training

relating to the protection of the rights of study participants.

The report did not mention Cummings

having used computer software to orga-

nize and manage her data. Her statement about making marginal notes using dif-

ferent color highlighters strongly suggests that she relied exclusively on manual

methods of organization and coding. Several of Cummings’ statements suggest a

kind of “accounting”, as in the following

examples: “Many listeners described expe- riencing a feeling of awe while listening” and “Many participants found themselves imagining what happened as well as what

could have happened.” Cummings reported that she used van

Manen’s phenomenologic approach. The article stated that Cummings main-

tained a journal “to record additional

observations and personal reflections.”

Cummings discussed the analytic process

in terms of steps she attributed to van

Manen: holding preconceived beliefs in

abeyance; undertaking a holistic reading of each transcript to get a sense of it as a whole; rereading the transcripts to identify statements or phrases that best represented participants’ experiences; identifying cate-

gories; and dwelling with the data to iden-

tify key themes.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

510 APPENDIXP = Answers to Selected Resource Manual Exercises

g. Cummings’ analysis revealed five essen- d. The report stated that Byrne engaged in

tial themes: (1) The story has a purpose;

(2) the story may continue to change as

different parts are revealed; (3) the story

is experienced physically, mentally, emo-

tionally, and spiritually; (4) Imagining the “what” as well as the “what if”; and (5)

the nature of the relationship colors the

experience of the listener and storyteller.

. Yes, Cummings provided rich supportive

evidence for her themes, in the form of

direct quotes from the interviews. For

example, here is a quote from themé 4,

from a listener: “There is no way you can

understand; there’s no way, even if you

had a similar experience, that you can put

yourself in their shoes.”

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX G)

a. Yes, Byrne and colleagues audio-recorded

the interviews with the 18 spousal caregiv-

ers. The recordings were transcribed by an experienced transcriptionist. The article

did not indicate how many pages of tran- scription resulted, but it did say that inter-

views were between 35 and 120 minutes long. In total, there were 45 interviews.

This likely resulted in hundreds of pages

in the dataset that had to be read and re- read, coded, and analyzed.

. Yes, at the end of the sub-section labeled

Data Collection, the authors indicated

that “data generation and data analysis occurred simultaneously, which supported

follow-ups with participants about emerg-

ing codes and categories.”

. The coding scheme was not described in

detail, but examples were provided. The

authors offered good information, for

example, about how the participants’ “I

don’t know” responses were open coded and then used in focused and theoretical coding. Most coding schemes in grounded

theory studies are complex, and space con-

straints in journals, unfortunately, make it

difficult to include an entire coding scheme.

line-by-line coding, and then all authors

contributed to focused and theoretical coding. The researchers noted that moving from line-by-line to focused coding was not a linear process. Excellent examples of the coding process were provided in the

section labeled Analysis. . It does not appear that computer software was used in the analysis of data for this

study. . Byrne and co-researchers described their

data analysis in rich detail. The approach to data analysis was Charmaz’s construc- tivist method, and excellent illustrations of

how the analytic process progressed were

provided. In their analysis, the researchers

also used sensitizing concepts from prior

research on caregiving and transitions to

guide data analysis. Charmaz’s approach

emphasizes examination of processes and creation of interpretive understandings. In

the article the authors highlighted “how processes enacted during transition for

caregivers are viewed as both individually

experienced and socially constructed via

interactions with other people.” (Note

that the analysis was based on an earlier

version of Charmaz’s approach, which

included open, focused, and theoretical

coding. In her most recent [2015] book,

Charmaz distinguishes initial and focused coding).

. Yes, constant comparison was used and

excellent examples were provided. . The article provided a good discussion of

the grounded theory and a useful concep- tual map of the process of reconciling.

i. Byrne and colleagues did (as do most

qualitative researchers) engage in a kind

of qualitative “accounting.” Here are

two examples: “While spouses were on

the GRU, most caregivers took daily trips

to the hospital as a means of maintain- ing normalcy...” and “Declines in their own health and function were a very real worry, because many knew that if

something happened to them, their spouse

would end up in long-term care.”

i APPENDIX P

No, Byrne and colleagues did not use met- aphors, although they used rich and col-

orful language to describe features of their framework (e.g., Getting into it, Getting on with it”).

Yes, the report indicated that Byrne (the

first author) wrote memos during the analysis: “When a code was raised to

the level of a category, the first author created a memo describing the category,

the elements contained in the category,

illustrative quotes that reflected the cate-

gory, and further ideas on which to follow

up to ensure theoretical saturation of the

category. These memos were shared and

discussed among authors.” The basic social psychological problem that emerged in this study was the care- givers’ and spouses fluctuating needs in

the transition home from the geriatric

rehabilitation unit. The basic social pro-

cess was reconciling to fluctuating needs,

enacted by caregivers to integrate their

past and present skills, roles, routines, and

circumstances. The theoretical framework

proposed by the researchers encompassed three distinct subprocesses: navigating,

safekeeping, and repositioning. Based on the excerpts presented in the text, this framework appeared to capture essential

aspects of the reconciliation process that

was needed in adjusting to the spouses’

return home.

= Chapter 26

EXERCISE 6.1: QUESTIONS OF FACT (APPENDIX E)

a. No, Cummings did not have a section of

her report specifically describing quality-

enhancement strategies. Her strategies

were presented in the second paragraph of

the “Data Analysis” section. Triangulation was not a key part of Cummings’ quality-enhancement strat-

egies. It is true that she gathered data

Answers to Selected Resource Manual Exercises 511

from both storytellers and listeners,

but this is not really data source tri-

angulation because the experiences of

listener and storyteller were considered

separately (1.e., the point of including the listeners was not to triangulate

information from the storytellers, but to

understand the parallel experience of the

listeners). Investigator triangulation was not really used either—that is, it was not

a team of investigators who undertook the analysis.

Several strategies were used to enhance

rigor in this study.

¢ Prolonged engagement/persistent obser-

vation. Cummings does not appear

to have used persistent observation in her research. Although she gathered

data from both parties to storytelling episodes, she did not (for example) go

back to participants and ask them to

reflect on transcripts and co-interpret

them. e Peer review/debriefing. Cummings used

peer debriefing. She “collaborated with

two professional colleagues and expert

qualitative researchers who reviewed

transcripts and findings.” ¢ Member checks. Cummings noted that

“findings were presented and clarified with participants to assess whether the

transcripts were accurate and whether identified themes resonated with them. The report did not indicate whether both listeners and storytellers were involved in the member checks, nor

how many participants were asked to

help. ¢ Disconfirming evidence. There was no

mention of searching for disconfirming

evidence. ¢ Reflexivity. The report indicated that

Cummings kept a journal to record

observations and personal reflections. Cummings also noted that the first step in the analysis process was to put aside preconceived notions and beliefs about the phenomenon under

study.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

¢ Audit trail. The report did not state

that an audit trail was maintained,

although this does not mean that it did

not happen. e Researcher credibility. The researcher is

a doctorally-trained nurse practitioner.

She noted in the introduction that the

issue of listening to traumatic events is

crucial for nurse practitioners, and that

little is known about the impact of lis- tening to stories of traumatic events on

nurses. The acknowledgements at the

end of the story suggest that Cunimings

herself was a listener to the story about

the crash landing—her brother was on

board the United Airlines plane that crashed into the Hudson River.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX G)

a. Byrne and colleagues devoted an entire

subsection of their report to describing

their approach to quality-enhancement, labeled “Criteria for Rigor.”

. The researchers used several types of tri-

angulation. First, there was method trian-

gulation. The primary source of data was

from interviews with the spouse caregiv-

ers, but these data were augmented with

observations of the interactions between caregivers and their spouses. The research-

ers noted that they “used triangulation

not to confirm existing data, but rather to

enhance completeness.” Another form of

triangulation was investigator triangula-

tion. Byrne did much of the preliminary

coding and analysis, but shared her work with her co-authors, and all researchers

contributed to the final framework. It could not really be said that time trian-

gulation was used, despite the multiple points of data collection. The researchers were less interested in verification in later interviews than they were in understand-

ing how the process of reconciliation evolved over time.

512 APPENDIXP ® Answers to Selected Resource Manual Exercises

c. Many strategies were used to enhance

rigor in this study.

¢ Prolonged engagement/persistent observation. It could be said that both persistent observation (the researchers’

very thorough and in-depth scrutiny of the reconciliation process) and prolonged engagement (continuing to

gather data and observe participants

over a 6-week period) were used as quality-enhancement strategies in this

study. ¢ Member checks. The report indicated

that the preliminary theoretical frame- work was shared with five caregiv-

ers as a member-checking strategy.

The authors noted that “Caregivers

reported being able to ‘see’ their own experience of transition in the processes

presented.” Moreover, the authors

stated that the framework was modified based on feedback from participants.

e Disconfirming evidence. The research-

ers did not discuss any efforts to search

for disconfirming evidence (although this does not necessarily mean it did

not occur).

¢ Reflexivity. The report indicates that the researcher maintained a reflexive

journal, and that entries were made

on an electronic notebook for each interview.

¢ Audit trail. The report stated that an

audit trail was maintained. Details were not provided, except to note that an

electronic field notebook was used to record audit trail details.

@ Chapter 27

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX F)

a. Yes, this was a mixed methods study. As described in the introduction, the study

had three purposes: (1) to describe fatigue

Generating and Assessing Evidence for Nursing Practice (11th ed.)

ee APPENDIXP ® Answers to Selected Resource Manual Exercises 513

(intensity, distress, timing, and quality) in

patients with stable coronary heart disease (CHD); (2) to determine if specific demo-

graphic, physiological, or psychological

variables were correlated with fatigue; and (3) to determine if fatigue was asso-

ciated with health-related quality of life. Quantitative information played a par-

ticularly important role in addressing the

second and third purposes but was also used to address the first. The qualitative

strand was used to enrich the description

of fatigue, i.e., the first purpose. No spe- cific mixed methods purpose or question was stated.

. The quantitative strand had priority in the study design.

. The design was sequential—data for

the quantitative strand were gathered,

followed by the collection of qualitative data.

. The design used in this study would be described as an explanatory sequential

design, using Creswell and Plano Clark’s terminology. Qualitative data were used

to explain and elaborate on the results of the quantitative analyses. The authors

themselves used a different name for their design: a partially mixed sequential

dominant status design. They refer- enced different authors for their design

typology. . The authors themselves used notation to

depict their design: QUAN = qual.

. Eckhardt and colleagues used nested sampling. There were 102 CHD patients

in the QUAN strand. Using patients’ scores on a measure of fatigue (the

FSI-Interference Scale), the researchers

identified participants with high, mod-

erate, and low levels of interference

from fatigue. Thirteen patients in these three groups participated in an in-depth

interview in which they were asked to

describe their daily lives and the fatigue they experienced. Thus, the researchers’

explanatory design combined elements

of the follow-up explanations variant as well as the case selection variant.

. No, quantitative data were not qualitized,

and qualitative data were not quantitized. . The researchers coded the qualitative

data and developed themes blinded to

the participants’ fatigue group (high, moderate, low fatigue), to avoid bias-

ing their thoughts about the qualitative material.

i. The report did not provide much detail

about how the actual integration took

place. For example, it is not known whether the authors created a meta- matrix. The report states that the two strands of data “were compared to deter-

mine patterns, enhance description, and

address any discrepancies. Qualitative

data were used to expand the overall depth of quantitative findings and provide

a more thorough description of fatigue.

The authors also noted that they paid particular attention to discrepancies and

viewed discrepancies as potentially “gen-

erative.” In their results section, they

provided a good example of a discrepancy

and how this led to further ideas. One

81-year-old participant in the qualitative strand was in the low fatigue group—a

score of zero on the FSI-Interference Scale—and yet in the in-depth interview

he stated: “I just get tired. Some days I almost start crawling.” The research-

ers speculated that this incongruence might “represent an accommodation to

decreased physical capacity because of

CHD.” Although analytic details were not provided, the researchers integrated qual and QUAN results throughout their

Results section, using numerous excerpts

from the qualitative interviews to illustrate and bring life to the quantitative findings.

j. Yes, the researchers presented an excellent side-by-side display (Table 6) that pre- sented quantitative findings, qualitative excerpts, and information about the inte-

grated analysis.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

514 APPENDIXP @ Answers to Selected Resource Manual Exercises

@ Chapter 28

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX A)

a. Yes, Nyamathi and her colleagues were testing the effects of an intervention that

would be considered complex—indeed, both the focal intervention and the com- parator intervention were complex. For

the intervention that was the focus of the research—the Dialectical Behavioral Therapy-Case Management (DBT-CM)

intervention—complexity was evident on

several dimensions, including number of weeks during which the intervention was

provided (12 weeks plus 3 months of extra support); number of components (group sessions, one-on-one sessions, then extra

support for needed referrals); number of

topics covered in the sessions (e.g., avoid- ing and eliminating cues to drug use, burn-

ing bridges to substance use, building a life

worth living); and the use of extra devices,

such as homework. It might also be said that the population being served was com-

plex, with complex needs and problems,

i.e., homeless female parolees or proba-

tioners. Study participants were diverse in terms of race, age, education, and number

of times in prison. b. Yes, the researchers used a nurse-

oriented theoretical framework called the

Comprehensive Health-Seeking Coping

Paradigm (CHSCP) as the framework that

guided the development of the study. The CHSCP, derived on the basis of a prom-

inent theory of coping and adaptation,

was developed by Nyamathi herself. The

theory helped to identify other factors that could affect the outcomes, and these fac-

tors were explored in the analysis.

c. No, the researchers did not mention the

MRC framework, nor any other interven- tion development framework. However,

they mentioned that their efforts used elements from community-based participa- tory research in developing the program.

d. The DBT-CM is a behavioral intervention

that had been previously developed and used in populations with mental and emo- tional disorders. However, the researchers

did engage in development activities to create specific intervention content and procedures. They established an advisory board with community stakeholders to assist in development. The researchers

also undertook qualitative research to understand the perspectives of homeless female offenders, the target group for the intervention. These efforts were described in a section of the article labeled “Program Development.”

. The researchers may have developed a logic model that presented hypothesized pathways, but they did not present it in this article.

. Pilot testing was not mentioned in the article.

. This evaluation of this DBT-CM inter-

vention does not appear to have had a

qualitative component. However, in their

“Conclusions” section, the researchers

noted that “Future studies necessitate a larger sample size and inclusion of a qual-

itative follow-up study to gain a greater understanding of areas of improvement and need.”

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX D)

a. The researchers developed and tested the K-DASH program, a culturally-tailored dietary intervention designed for Korean Americans with high blood pressure. K-DASH would be considered complex, with complexity along several dimensions:

the number of weeks during which the intervention was provided (10 weeks); the

number of distinct components (two in- class education sessions with interactive

group activities in Weeks 1 and 2; 3 indi- vidually tailored nutrition consultations in

Weeks 4, 5, and 10; and 1 follow-up tele-

phone call in Week 8); content coverage

Generating and Assessing Evidence for Nursing Practice (11th ed.)

a APPENDIX P #

(as described in Table 2 of the article); and

complexity of the outcomes (blood pres- sure, biochemical parameters from blood

and urine tests, and level of adherence to

K-DASH dietary guidelines).

. The theoretical background of the inter-

vention was not elaborated, perhaps because K-DASH was an adaptation of an intervention that had previously been developed and found to be effective (DASH—Dietary Approaches to Stop Hypertension). A key aspect of K-DASH was the work that the researchers needed to undertake to make it cul- turally appropriate for a population

with distinctive food habits, Korean

Americans.

. The researchers did not use the MRC framework, but they did mention another

framework that involves participatory

principles consistent with develop- ment strategies in the MRC guidelines

(Community-Based Participatory

Research). The researchers noted the

“step-wise” pattern they used, which has

much in common with the MRC frame-

work: (1) identifying the cultural needs of

the target population; (2) evaluating exist- ing research and evidence; (3) determining the core principles of the intervention; (4)

translating the core principles into cultur-

ally applicable practice; and (5) assessing

the content validity of the intervention.

. The researchers convened a series of focus group sessions that included bilingual researchers, clinicians, and members of

Korean American families. In addition to assessing the cultural relevance of the intervention components, the panel was

invited to provide input with regard to potential barriers for pursuing a healthy lifestyle among members of the target

group. . The study was described as a pilot and

feasibility study. . This study was primarily quantitative.

Qualitative work in the development phase contributed to the specific features of the intervention, and it appears that

Answers to Selected Resource Manual Exercises 515

some qualitative data regarding satisfac-

tion with the program were also collected in the pilot. Thus, we might characterize the overall design as qual > QUAN +

qual. The researchers noted that a more

intensive scrutiny of qualitative data

would be desirable, in addition to testing efficacy in a larger sample: “The research

team concluded that a thoughtful integra- tion of the qualitative data for this inter-

vention (particularly the intensity and dose

of the intervention) with an in-depth anal-

ysis of data from a larger sample is war-

ranted before definitive recommendations can be made to clinicians in the field.”

= Chapter 29

EXERCISE C: QUESTIONS OF FACT (APPENDIX D)

a. The researchers did not mention in the

title of the article that the study was a pilot or feasibility study. However, the abstract mentioned that this was

a pilot study (in the section called “Conclusions”). The abstract also men-

tioned that their study was used to “test the initial feasibility” of the K-DASH

intervention.

The authors used both terms in the arti-

cle. They referred to the study as a “pilot study” in the abstract, and as a “feasibility

trial” in the introduction. The phrases “pilot testing” and “pilot study” were

used several times in the article. In the abstract to the article, the authors

stated that the objective was to “obtain preliminary evidence of efficacy” of K-DASH. In the last paragraph of the

introduction, they stated that they com-

pleted “a feasibility trial to evaluate the initial efficacy of this intervention.” Later, in the methods section, the authors dis-

cussed their intent “to test the efficacy

and feasibility of the K-DASH education intervention.” Specific aspects of feasibility

Generating and Assessing Evidence for Nursing Practice (11th ed.)

516

in which the researchers were interested

were not specified, nor were criteria for

decision-making stated. It appears that the researchers did address two process-type study outcomes. In the

methods section, the researchers stated

that they gathered data “to assess the level

of adherence to the K-DASH education guideline.” In a section labeled “Process evaluation,” the researchers also briefly

discussed their efforts to assess partici- pants’ satisfaction with the program (i.e.,

its acceptability). ? . Yes, the main objective of the pilot was to

obtain preliminary evidence of the inter- vention’s efficacy. The researchers used statistical tests to test the hypothesis that the

intervention would lead to improved blood pressure and biochemical outcomes. They

reported several statistically significant improvements (and they considered the

improved blood pressure measurements clin-

ically significant). The authors did not report

effect size estimates or confidence intervals. . A one-group pretest-posttest design was used—there was no comparison group. In

the Discussion section, the researchers com-

mented that their 1-group design was a study limitation, and “the findings could have been

influenced by as yet unidentified biases.”

. The total sample size was 30 people,

28 of whom completed the 10-week intervention.

. This pilot study gathered primarily quan-

titative data. Some qualitative data regard-

ing satisfaction with the program were

also collected. The researchers noted that a more intensive scrutiny of the qualitative

data would be desirable but did not elab- orate on what additional qualitative data had been collected.

i. The researchers concluded, as described in

the Discussion section, that the K-DASH

intervention was “efficacious” in their

sample of participants. They stated that “Future studies should be conducted to cross-validate the findings of this study by means of full-scale randomized, community-based effectiveness trials.”

APPENDIXP ® Answers to Selected Resource Manual Exercises

j. The researchers did not present specific suggestions for revising their intervention protocols. However, in the section labeled

“Process Evaluation,” they mentioned an interest in integrating qualitative data for this intervention “particularly the intensity

and dose” before making definitive recom-

mendations to clinicians.

@ Chapter 30

EXERCISE C.1: QUESTIONS OF FACT (APPENDIX K)

a. The purpose of Chase and colleagues’ meta-analysis was “to determine the

overall effectiveness of interventions designed to improve medication adher- ence (MA) among adults with CAD”

(coronary artery disease).” The indepen-

dent variable was receipt versus non-

receipt of a special intervention, and the

dependent (outcome) variable was med- ication adherence. Chase and colleagues articulated two specific research ques-

tions: (1) What is the overall effectiveness

of medication adherence interventions on MA outcomes among patients with CAD?

and (2) Does intervention effectiveness

vary as a function of characteristics of

the intervention, the sample, or the study design?

b. To be eligible for this meta-analysis, a pri- mary study had to be a two-group (treat-

ment versus control group) study that

tested the effectiveness of an intervention to increase medication adherence in adult

patients aged 18 or older with a diag- nosis of CAD. A total of 24 studies (but

28 comparisons) met these criteria. This

meta-analysis did not have as an inclusion

criterion that the patients had to have a medication adherence problem.

c. The reviewers relied primarily on elec-

tronic database searches. They searched in about a dozen databases using a wide

array of terms. They also used hand

Generating and Assessing Evidence for Nursing Practice (11th ed.)

os APPENDIXP ® Answers to Selected Resource Manual Exercises 517

searching of 57 relevant journals, author

searches of key researchers in the field, and ancestry searches using the bibliogra- phies of identified studies.

. This study did not present a PRISMA- type flow chart summarizing the search and selection process. No information

was provided about how many studies were initially identified through their

search strategies and how many were

eliminated for various reasons. This is

not typical in meta-analyses—recent guidelines for reporting meta-analyses

indicate that a flow chart should be provided.

. It was stated in the abstract and in the

Results section that a total of 18,839 peo- ple participated in the primary studies that were included in the review.

. Participants in the primary study were,

on average, 62.9 years old; this was the

median of the study mean ages. The

majority of study participants were male and, in studies for which ethnicity was

reported, white. Many studies reported that their participants had additional

chronic diseases, such as hypertension and

hyperlipidemia.

. According to the Table 4, 20 of the 28 comparisons involved random assign-

ment to a treatment or a control group. Thus, the review included studies with

both experimental (7 = 20) and quasi-

experimental ( = 8) designs. . Study quality was assessed using a domain approach, rather than a scale approach. Each study was coded for the presence or

absence of certain features, including ran- domization, use of a theory, the blinding

of data collectors, and the use of the rec-

ommended analytic approach, intention to treat. All ratings were performed by two

independent research specialists, and then compared and discussed until there was

100% agreement.

i. Studies were not excluded on the basis of

quality, per se, but they were excluded if they used a very weak one-group pretest-

posttest design.

j. The effect size used in this study was the

standardized mean difference (SMD),

which we referred to in the textbook as d.

. Yes, the researchers tested for heteroge-

neity. They opted to use a random effects model, even before learning that the test

for heterogeneity was statistically signif-

icant because they expected variation of effects across studies.

. Yes, Figure 1 presented the main effects on

a study-by-study basis in a forest plot.

. The overall effect size comparing adher- ence outcomes for those in an interven-

tion group compared to a control group was .229. As shown in Table 2, the 95%

confidence interval around this value was

.138 to .321, which is significant because the interval does not include zero. We

can be 95% confident that the true bene-

ficial effect lies somewhere in the interval

between .14 and .32 (rounded values).

. With regard to Figure 1:

e The study with the largest effect size

was a small study published in 1985 at the bottom of the forest plot. The ES for this study was 2.521, favoring those in the intervention group.

e Yes, there were many studies for which

intervention effectiveness was nonsig- nificant—all those where the lines for the 95% CI crosses the vertical line for 0.00. Indeed, this was true for most of

the studies in Figure 1. e Yes, there were 5 studies for which

the value of d was negative, indicating outcomes favoring the control group.

However, in none of these cases was

the result statistically significant. This can be seen by examining the values

of the lower and upper limits of the 95% CI. For these 5 studies where the value of d was negative, the lower limit was negative but the upper limit was

positive, indicating the possibility that the value of d could be 0.

. Yes, numerous exploratory subgroup

analyses were undertaken to assess factors contributing to the heterogeneity of effects

across studies. One particularly interesting

Generating and Assessing Evidence for Nursing Practice (11th ed.)

518 APPENDIX P @

finding was that MA interventions delivered by nurses were especially effective. Another

finding was that interventions in which healthcare providers were given informa- tion about patients’ adherence were more

effective than interventions without this component. Also, interventions initiated in inpatient settings were especially effective.

Many of the subgroup analyses, however,

yielded nonsignificant results. It should be noted that the small number of studies in

the sample would make it especially diffi-

cult to find significant subgroup effects (this issue is discussed in Chapter 31).

EXERCISE D.2: QUESTIONS OF FACT (APPENDIX L)

a. Beck undertook a metasynthesis of six of her own studies in her program of research on

traumatic birth and did not search for other qualitative studies on the same or a related

topic. Beck’s was, thus, a special type of metasynthesis. (Of course, as an expert in the

area of traumatic birth, Beck is thoroughly

familiar with the literature in her field).

. This metasynthesis was interpretive. Beck

sought new ways of understanding the

experience of a traumatic birth. . Beck did not explicitly discuss this contro-

versy, although her approach would have

integrated any of her studies on the topic of traumatic births, regardless of tradition.

Her metasynthesis combined five phenome-

nologic studies and one narrative analysis. . The data in the primary studies were all

derived from self-reports, exclusively from Internet-based self-reports.

. A total of 175 mothers participated in Beck’s six primary studies.

. Beck used Noblit and Hare’s meta-

ethnographic approach. Beck provided an

excellent description of the seven phases of the approach.

No, a metasummary is a strategy devel- oped by Sandelowski and colleagues, and

Beck did not follow this approach.

Answers to Selected Resource Manual Exercises

Beck identified three overarching themes in her studies of birth trauma: (1) Stripped

of protective layers; (2) Invisible wounds;

and (3) Insidious repercussions. Beck also

discovered that traumatic childbirth had a domino effect on various aspects of new motherhood, which she identified as

amplifying causal looping. Yes, Beck included some powerful ver- batim quotes from the primary studies in support of her thematic integration.

# Chapter 31

EXERCISE C: QUESTIONS OF FACT (APPENDIX A)

Yes, in a section labeled “Program Development,” the researchers explained

that the intervention was developed with the input from a community advisory

board with community stakeholders.

Homeless female offenders also provided feedback via focus group discussions.

The researchers themselves did not label the study as comparative effectiveness

research (CER), but several elements of

CER were embodied in the study. In par- ticular, the study involved a comparison of two alternative interventions, the dialecti-

cal behavioral therapy-case management

(DBT-CM) intervention and a health pro-

motion intervention.

. The trial could be considered pragmatic

in many respects, although the researchers did not use this term. The trial was con-

ducted in real-world settings using eligibil- ity criteria that were not overly restrictive.

These are also features of CER. . No, the researchers reported their trial

results as odds ratios (Table 2), which is

the statistic generated in logistic regres-

sion analysis. The absolute risk reduction

(ARR) for any drug use at 6-months after baseline, based on data from the complete case analysis data in the supplementary

Generating and Assessing Evidence for Nursing Practice (11th ed.)

- APPENDIXP ® Answers to Selected Resource Manual Exercises 519

table, is 15.3%: 42 out of 58 in the

DBT-CM group (72.4%), compared to 35

out of 58 in the health promotion group (60.3%) were abstinent for drug use. This

translates to an NNT of 7. e. No, the researchers did not undertake

(or at least they did not report) any sub- group analyses. Their sample size was relatively small, and this may have led to

their decision to not undertake analyses with subsamples. They did, however, hint at the possible value of racial/ethnic sub- group work in their Discussion: “Gaining

a greater understanding of differences between racial and ethnic groups may

inform modified approaches to improve outcomes for Black and Latina homeless women.”

f. Yes, in a section of their Discussion sec-

tion labeled “Limitations,” the authors

stated: “Our findings relate to adult women offenders across a wide age span who resided in California. Our findings may not be generalizable across other parts of the United States.” They did not provide information on how California might be different from other locales in terms of types of services, policies, or populations.

g. No, there was no mention of applicability

in the paper.

& Chapter 32

EXERCISE C: QUESTIONS OF FACT (APPENDICES A—L)

Questions of Fact a. All of the articles in Appendices A

through M were published in jour-

nals that have an impact factor rating.

However, not all the journals are listed in the journal table in Supplement B for this chapter. For example, the Hountz et al. study (Appendix M) was published in the Journal for Healthcare Quality. This

journal is not listed in our impact factor table because it is not a nursing journal, even though nurses do publish in this

multidisciplinary journal. It is listed in

the Science edition of Journal Citation Reports in two subject categories: (1)

Health Care Sciences and Services, and

(2) Health Policy & Services. The impact

factor of this journal in 2017 was 1.29.

The article by Wilson and colleagues

(Appendix H) was published in the jour- nal Orthopaedic Nursing, with a 2017 impact factor lower than 1.00 (.63).

. As mentioned in the comments for ques-

tion (a), one appendix article was pub- lished by a nursing journal with an impact

factor of less than 1.00—Wilson et al. (Appendix H).

. With some minor variations (espe-

cially in the introduction and method sections), all but one of the articles

followed a traditional IMRAD format (although “Results” were reported in a section called “Findings” in several). The article that deviated most from the

IMRAD structure was the article by

Yackel and colleagues (Appendix C),

which is not surprising given that this paper summarized an EBP project rather

than primary research. . The majority of articles were multiply

authored. The exceptions were the papers by Cricco-Lizza (Appendix B), Cummings (Appendix E), and Beck (Appendix L).

It might be noted that all of these papers

were written by qualitative researchers.

Only in the paper by Byrne and col- leagues (Appendix G) were the authors

of a multiply-authored paper listed

alphabetically. . None of the reports used first-person

narratives. The authors used third- person narrative to describe their own

actions (“The first author engaged in

line-by-line coding,” Byrne et al.) or used the passive voice (“Key and general

informants were purposively selected,”

Cricco-Lizza).

Generating and Assessing Evidence for Nursing Practice (11th ed.)

520 APPENDIXP &

@ Chapter 33

EXERCISE C.1: APPENDIX N

a. This program announcement (PA) funded

projects through the RO1 and R21 mechanisms, as described in the section

“Mechanisms of Support.” For RO1 applications, this particular PA

expired July 30, 2006.

Nine other institutes within NIH, besides

NINR, participated in this PA. Yes, the PA specifically indicated that research on behavior-related interventions

was being sought. . Yes, the PA specifically mentioned an

interest in studies that explored “basic mechanisms of the conscious perception of pain and the affective responses to pain.”

. For this PA, the four major sections of

the grant application were restricted to 15

pages.

EXERCISE C.2: QUESTIONS OF FACT (APPENDIX N)

Total direct costs = $175,000; Total requested funds: $259,000 The proposed timeframes were May 1, 2006 to April 30, 2008 Five people were listed as key personnel.

The PI (McDonald) was proposed at a 20% level for two academic years, and at a 50% level in the summers.

Yes, the Specific Aims section started on

page 14, and the Research Design and Methods section ended on page 28, for a total of 15 pages. McDonald presented her hypothesis in the

Specific Aims section, which is consistent with guidelines.

McDonald described her own prior research on pain communication in the

“Preliminary Studies” section. She men- tioned 9 prior studies.

Answers to Selected Resource Manual Exercises

McDonald’s “Research Design and

Methods” section had the following sub-sections: Design; Sample; Procedure; Video Clip Experimental Manipulation;

Measures; Content Analysis; Summary

of the Methods; Analysis; Hypothesis;

and Summary of the Analyses.

McDonald proposed a double blind ran-

domized (experimental) design. McDonald proposed a total sample of 300

participants; this sample size estimate was

based on a power analysis. . Blinding was proposed for study partici-

pants, the graduate assistant administering

the “treatment,” and the people doing the content analysis of participants’ responses.

Yes, it was proposed that participants be

compensated with a $20 money order and

a publication about pain management.

Yes, multivariate analysis of covariance

was proposed.

EXERCISE C.3: APPENDIX N

R21, an Exploratory/Developmental Research Grant Award Nursing Science: Adults and Older Adults (NSAA)

. The priority score was 167, on a scale that

ranged from 100 (most meritorious) to 500.

The study section had human subjects

concerns. Two reviewers requested a data and safety monitoring plan, and another had concerns about future use of the proj- ect audiotapes.

EXERCISE C.4: APPENDIX 0

(se

The study section that reviewed this grant application was the Nursing and Related Clinical Sciences Study Section.

The total amount of funding for fiscal year 2017 was $657, 200; this included

$459,571 in direct costs and $197,629 in indirect costs (overhead).

The project start date was September 14,

2017 and the end date is July 31, 2021.

Generating and Assessing Evidence for Nursing Practice (11th ed.)

re APPENDIX Pm

EXERCISE C.5: QUESTIONS OF FACT (APPENDIX 0)

a. Yes, the “Specific Aims” statement indicate

that Cong and her team did preliminary work in which they found “that cumulative

pain/stress experiences in early life are sig-

nificantly related to altered neurobehavioral

outcomes in preterm infants cared for in the NICU.” This preliminary work was funded by NIH in a K23 career development grant.

Yes, in the Specific Aims section Cong

stated that the primary hypothesis was this:

“Cumulative pain/stress in early life com- bined with gut dysbiosis...increase the risk

for the neurodevelopmental morbidity in preterm infants during early childhood.” The proposed study is longitudinal. Preterm infants will be followed from NICU hospitalization until 18 to 24 months corrected age.

The study design is observational/nonex- perimental. Data on the infants will be gathered over time, but there will not be any research-related intervention.

Gleaned from information in the Specific Aims and the Project Summary (page 2

of Appendix O), the primary PICO ele- ments are as follows: P = preterm infants admitted to the NICU; I = high levels of

pain/stress experiences in early life (in the NICU); C = lower levels of pain/stress

experiences in early life; O = neurodevel-

opmental morbidity. In this study there are also mediating variables: gut dysbiosis and genetic susceptibilities. According to the Project Summary, daily pain/stress events in the NICU will be mea-

sured using the NICU Infant Stressor Scale.

Neurodevelopmental outcomes at 36 weeks corrected age will be measured using the NICU Network Neurobehavioral Scale. The researchers will attempt to recruit 200 preterm infants. The Project Summary indi- cates that the final analysis is expected to be completed with a sample of 160 infants. In other words, they expect that 40 infants

(20%) will be lost to attrition. The brief

summary documents did not describe a

Answers to Selected Resource Manual Exercises 521

power analysis. However, in the “Response

to Reviewers” document, the reviewers

asked for clarification of the researchers’ power analysis, so we can assume that a power analysis was undertaken.

ANSWERS TO CROSSWORD PUZZLES

1G >.G 1 19)

Chapter 1

14 r 3

Ly | TE | eI) oy | ve] 99) 1p is I

Cc A | ¢ | 1 () s 17

; U | N @) |] L

18 ¢

Pp : D

afe[a[ufi[r]y am 21

rd 4 fc) z a rl Zz fea)

Chapter 2

Generating and Assessing Evidence for Nursing Practice (11th ed.)

522 APPENDIXP Answers to Selected Resource Manual Exercises

Zzlalo|a’

FiQl|a|sl|so

it 2 3 4

12 DAE eRe SE Ne aD abeaNa eT Pi

Ss H I Ge L

8 °G Ari TLE |) K E ’p E/|R H G A|M

T N T 0 N R N

U "Cc PlRio|trlolclo T

12 R/AlD|o|N U U E 13 14

A N L S| 1) Gi N F

1S 16, Di PAti| ca: eat NS R|A |W. Vv D F

I T T T ‘Cc E E 18

2 c N U Oo U Bb Se 22. (23 R oo ballot S th P

24 25 E T sir Arl|r\s O 26 27. 28 29. | ee Ti erie T

30 a1 2

Ba Vn Eh Rael ea Nn E M H 33 4

35 R|E 10) JC 2 1 Mee th te acl yp ie

rr lalricloln S N 13° D D s|tlulply G o|N

Chapter 3

1 2 3 4 S s R s | Cc T 6 7

8 INS OM MSNE | 3p PS aN a Cen. ep TOR NG MeAws! eile E

7H OBA EGE : 9 10

L Pei LORNEP: SoA | Val ae

L it I a lly 12 13, 4

M/olR|& s|clol|ele B r G

iy 16 17 J 1 B R

18 19 20 TiH|ElolR clo|m/P|]Lle E

I Cc A U F L 2

M Te L P;R/IO/O A 22.

E if P P R T 23 aw

Vo) SES RS| Bols) T|wi|o E I

E oO s oO 25 26 27 divls Blri]als ujels|tr 0

Chapter 4

O|mlal>| =z

Chapter 6

fl iss! |] ill ory

3 clplolelslialzlols/z/

RPlalala| >

S/H! 2Zlol/al>la|n

foe APPENDIXP # Answers to Selected Resource Manual Exercises 523

Seno

IRE

Chapter 10 |} R|E

Chapter 8

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Answers to Selected Resource Manual Exercises APPENDIX P 524

S = ( Z / O } / 4 A / 5 ] a l a l o l ] z

< a >

|B)

= / 0

n = )

c o

n Bo ak e)

O } x A

e e

|<]

2 / a / o / s

i= }

i )

K P

(R P)

a i e ]

a l o

Q =

O o

n [2 ]

= Ss

L <

o |

| |

| ee

- o

Z z

b e

n E i d

a a d

V l o ; z l e | a l z

> a

< )

= )

o a

A l e

|N| ]

E e

B m

Z i

n Z

a )

fo }

[a 4

4 ez

O [Z |

|e]

O L m

n a

m o s

P l , O o ; e |

i )

[e ns

Al)

n l n

f i)

= a=

FE ]

a 4

al 9 ]

O ; z / a /

Q 4

e 4

a )

(=)

2 °

j a

(S s)

n Z

mn !

Pl as

a l a n

= ~

|S)

P / O l e | S } | e ) a

Z l

o l e

_ <

a )

7 )

pay )

-2 ]

0 O 1 e /

= B o

z i)

Er a

a Ka

< LA

|e|

< <

2 }

S| )

i e

n <3 )

< a )

a i= )

= )

e l e l m e |

a i m )

S| ]

L e

< i

| ]

Oo]

( 4

5 e e

O o

pa ]

o l e

> L e

& =

< =|

> le @

SQ]

& >

Z Kt (

o l e

= jn

> |

e )

iS )

a >

5 a e

a =

| / % / O ; O } | a A ] ~

n A

w u

w A A / 4 / Z 2 / A ) / O ]

=I n i a

n =

re )

= (S )

- nO

|<]

a] —

La ]

Oo}

3 2

z =

=| O

LP )

O j a m l

a l z

le t)

h i n

Chapter 13

ic )

e e

& 2

> =

A O

n 2

| )

S e

i= )

- <

i g

> Zz

= )

B l e ]

a °

2 oll

acl

Pa l

< <

a =)

io )

w ~ ) / a l a

l e

n o l

A i

Z z

i }

o O

n e

Q l n

e y

e o

i Z z

is )

iS)

n e s

> |

- a

e =)

M e

r= )

iS)

4 S / e } e | e

= a

v7 ]

a =]

x o )

v °

Re a

a 1S)

° W e

| O h ]

E o

= =

id )

i =

n = )

mM! )

Chapter 14

Chapter 12

k: Resource Manual for Nursing Research: Generating and Assessing Evidence for Nursing Practice (11th ed.)

525 Answers to Selected Resource Manual Exercises APPENDIX P

M|A|T {RII

N/|O/;R/|M/A/L

O|D|D |S

19 H

24 COIS COP NS SI] Aj) eS 13

AT RSS| BAS ey

ETT

| ~ Q sa) <>) = < yy < Flan

i> —

3) ~ Quy isv) Pac O

i )

2 | ©

< ) / - ) 2 z

n (o}

lo) <

4 |

= a

= )

| &|

< j e

is)

La ma)

Zz] e

(=) a n

cy °

) <

O | e |

<|e| =)

9 ) 4

-° a

2 S)

— | . 0

z e

> =

° e e s

M a l

Q l a \ | n | a

= [24

= )

o o

e m

= )

Ss) r=)

S e

<t|/Rz\|oa <

e y |

a = )

4 >

4 2

° Z z

==] e n | e | % ) / O ; z / O } R

m l z )

e *

o o

a i )

Ea &

i ]

Z| of

| |

Lal i=)

a) |e

WO} O;

Me) me) am

LO] &

Chapter 16

Chapter 18

Answers to Selected Resource Manual Exercises APPENDIX P 526

a _

V i o l ;

z / a 4 / a x l z a l o a

ae )

S e e

Ey |

Sh]

eu lz

[a S)

|s <

* Z z

= 0

E s

he d

PS)

la-l il

g e

® a s

s s

le es

CaP -a

iy Fee

s el

TS)

a =|

o a

e e

o >

& a= ]

~ 4

= )

< --)

A ]

ee )

a e

| Ol

St )

So )

a Z z

_ ae

= ig

_ Zz

= )

& |

4 °

Z z

° “a

° -

- n

r=)

l = l | s ) A l

a=]

o } < } e } ] - a t o l z

a 2 )

n >

_ <

| S )

R e a l e

e t e }

a l a t e }

> < P

a is)

i- 4

= )

n 5

e y e )

e l e

lel

e l e l o l z

B R I M

e a l o l / a l | a n i l e l o l z

e H

| O ; } n ] / S \ / a / e

KA )

PS)

eS ]

> a

° 4

-4

A ()

je m

| a]

a <

L =

< | 2 | O ] , 0 | > ] <

(a 4

/ S ) — ) / o ] m i e

Z z

1o)

= l z l e l a

= )

w e

So ]

e l ]

| e = | — | x } / a / a

a 4

ta al

< =

L O }

Ol]

= | e l e l e j o

- >

[ 4

j o

be s

Esl

< a

F a e

4 2;

O | S | a } a

< -

= )

o O

[a 4

> *

()

ma}

a <

° <

& =>)

Ss )

WA L

A / S

IO ]

M@)

a L )

= j l z l < | z l e ]

Be a

= )

a <

= B l e

+ oO

R / e l a / a l a } < } / y u l a

2 )

k e

= = )

a .

& <

& nO

a o

B =|

& Be e

Ae l

o \ e } e l a } e | — l a l e

- <

a a!

= )

on l

and l

Mani

an il

oad

Chapter 21

l O ;

O / O ; / R i / z l e l | l a } e a i o

Se )

f=)

4 n

|| a@ )o }

ie )

& &

4 &

i= )

ee )

=| 2 { o l o ; e |

m i a t a

= |

| <

- ‘S )

< e X

2 jo

| x

fa l

fo e

ie )

= &

Z z

R A Z ]

e y O

7 )

I }

} R l }

Z z

n El en !

e V

i t

tb l

test )

|<]

mi)

ea]

< _

= )

vA }

nN)

an! )

.0 |

2 / 0 ]

a 7 )

2 Z / O l N Q

(2 4

se ]

a l e

° z

- < S y

- Lz

lle

al] =

& e i )

O l e ]

eH)

ol]

« ) 4

= ]

& <

Q e C )

22 }

le ]

2 A

¥ ]

2 Jo m

i )

Zz ,

D n

Q ie

) x

W e

SM)

ae]

m i s !

« J e

| |

2 a ?

iS )

< -

- 4

i )

e V

a l

2 8

j e ?

Q l r a ] A

° <

> a

a e

| 3 ] / o } o |

iS )

> =

2 ?

|?)

3 a

a i o l i )

me )

s L =

(P|

<sele ll

zz,

<> )

Q =

_ ie

)

a a

L e

& a >

= Zz

n °

- Ro

oO]

= 2

i )

El en !

Pi ed )

L a !

i )

= ]

S a

= B e n e t

ae!

= <

a a

P e

e a

el o]

Pi an

e o

= <

a o

(= )

e a

k i

e e e )

= )

= L e

L i e

e e )

Chapter 20

APPENDIX P

Chapter 24 ; Chapter 26

Generating and Assessing Evidence for Nursing Practice (11th ed.)

Answers to Selected Resource Manual Exercises APPENDIX P 528

¥,

Dy Ad eA

17 OER R

LG) EONS | 0 1D) | S| Bs VaR 31

Chapter 27

Chapter 29

PO ;

O ; z ] e l e | z

ml z)

e A

A / a ]

— | e ] >

ma)

e i m a ) a l ]

a L s

A ke ?

|2 0

O ;

& |=

ie )

l e s

> <

a >

Q e

|O }O }

2 JO ;

< = f )

> <

S )

_ %

iS )

& =

% |

| >

L A ]

i= ]

= |

& E

r=)

> =)

k K

Q Z

P ] R ] A

= ]

-- )

i =

KA ]

K ) O ; R } >

La l

e l e

x O } e

a Z s

L e

i )

[a 4

ie )

i )

L y e

= }

Ran

a e s

L e e

“|

| [ 4

< nO

= IN|

.e )< )/

e l l a

B a

o e

& oO

O a l e e

° =

=| x

a 2

< 2

a an e

O |e }

a e

Ie ?

j e

> L e

a e )

m/ s}

e a t e } a l — a | e ]

LO }

< / 2

ie )

a K > | < | R } - | e a

< =

e~ |— }

2 / 0

< Q

a >

e = )

Ie "

|2 )/ e\ |

z ) a l e

A i)

i e

v z

Q a

oO}

o La

|e)

a l e e

lal

z l e l e a l o l z

f e

° a

i °

f ma y

J .

S s

~ |

K 2 L = / S } e } a l e a l a s a

2 z

Pa ne

a m2

o e

= |

A } ; a ] o

n <

ie )

Z z

_ >

i )

[K S

| |

2 p t

A L P )

an)

O l z l | a

ie )

S i )

S s

- =|

& =

4 =)

< 2)

= “ |

< ] =

4 A> )

| 2)

< m

iS )

= s

2 ey

= )

3 i )

si fa l|

L < | / O ] a l z l e l a

3] < | z | z ] e / o

= &

a Re

- x

| ~

o a

Bl om

Lol

a |e

Lac!

a |e

Chapter 30

APPENDIXP ® Answers to Selected Resource Manual Exercises 529

i] ES) |

Chapter 33

Chapter 32

‘

Generating and Assessing Evidence for Nursing Practice (11th ed.)

_ a ae) ee : a I > a -

” ; a er a)

Dat song (> * (y ) eo = ee ee i" - : IF) ye r ed) i NO A um aie EY : F es

ls ae = | ee mae | - val Pica + vs ‘oh e aie _ < : sore , —_ ss oe e ee we ' :

7) Ww «se bls |

ole = bade

mien

See | 6) 4 pd. oa )

ee ¥ i

Ti:

3 Meashin BY ae Z i ; > -

icons - 3 | fa o >

vee UCN sith {Law OOP ITY CraapeRT Ss yrmney

iD)

Ses

——

ve & —, !_— 2

~—

L c 6 0 S 9 9

RESOURCE MANUAL FOR

NURSING RESEARCH Generating and Assessing Evidence for Nursing Practice

ELEVENTH EDITION

Denise FE. Polit, PhD, FAAN e Cheryl Tatano Beck, DNSc, CNM, FAAN

. Perfect Your Nursing Research Capabilities with Best-Practice Resources

~The ideal companion to Nursing Research: Generating and Assessing Evidence for Nursing Practice, 11th Edition, this knowledge-building Resource Manual strengthens your understanding of essential research concepts and enhances your ability to comndsinly gppay and critique research studies. | ~~

° Crossword Puzzles provide an omenaining and Guallengings review of key terms and | concepts.

° Study Questions encourage critical thinking and reinforce the most t relevant content from each textbook chapter.

: Be: Exercises hone your Ayeai to read, comprehend, cal critique nursing Stadics ~ most effectively.

* The Toolkit delivers fast online access to dozens of timesaving, adaptable resources that can’ be downloaded and customized to meet your specific needs.

earl

— @.WoltersKluwe #—. #£x4£ ~ ieee =