Nursing Research
Methods and Critical Appraisal for Evidence-Based Practice
NINETH EDITION
Geri LoBiondo-Wood, PhD, RN, FAAN Professor and Coordinator, PhD in Nursing Program, University of Texas Health Science Center at Houston, School of Nursing, Houston, Texas
Judith Haber, PhD, RN, FAAN The Ursula Springer Leadership Professor in Nursing, New York University, Rory Meyers College of Nursing, New York, New York
Table of Contents
Cover image
Title page
Copyright
About the authors
Contributors
Reviewers
To the faculty
To the student
Acknowledgments I. Overview of Research and Evidence-Based Practice
Introduction
References
1. Integrating research, evidence-based practice, and quality improvement processes
References
2. Research questions, hypotheses, and clinical questions
References
3. Gathering and appraising the literature
References
4. Theoretical frameworks for research
References
II. Processes and Evidence Related to Qualitative Research
Introduction
References
5. Introduction to qualitative research
References
6. Qualitative approaches to research
References
7. Appraising qualitative research
Critique of a qualitative research study
References
References
III. Processes and Evidence Related to Quantitative Research
Introduction
References
8. Introduction to quantitative research
References
9. Experimental and quasi-experimental designs
References
10. Nonexperimental designs
References
11. Systematic reviews and clinical practice guidelines
References
12. Sampling
References
13. Legal and ethical issues
References
14. Data collection methods
References
15. Reliability and validity
References
16. Data analysis: Descriptive and inferential statistics
References
17. Understanding research findings
References
18. Appraising quantitative research
Critique of a quantitative research study
Critique of a quantitative research study
References
References
References
IV. Application of Research: Evidence-Based Practice
Introduction
References
19. Strategies and tools for developing an evidence-based practice
References
20. Developing an evidence-based practice
References
21. Quality improvement
References
Example of a randomized clinical trial (Nyamathi et al., 2015) Nursing case management peer coaching and hepatitis A and B vaccine completion among homeless men recently released on parole
Example of a longitudinal/Cohort study (Hawthorne et al., 2016) Parent spirituality grief and mental health at 1 and 3 months after their infant schild s death in an intensive care unit
Example of a qualitative study (van dijk et al., 2015) Postoperative patients perspectives on rating pain: A qualitative study
Example of a correlational study (Turner et al., 2016) Psychological functioning post traumatic growth and coping in parents and siblings of adolescent cancer survivors
Example of a systematic Review/Meta analysis (Al mallah et al., 2015) The impact of nurse led clinics on the mortality and morbidity of patients with cardiovascular diseases
Glossary
Index
Special features
Copyright
3251 Riverport Lane St. Louis, Missouri 63043
NURSING RESEARCH: METHODS AND CRITICAL APPRAISAL FOR EVIDENCE-BASED PRACTICE, NINTH EDITION ISBN: 978-0-323- 43131-6
Copyright © 2018 by Elsevier, Inc. All rights reserved.
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This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).
N o t i c e s Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.
With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.
Previous editions copyrighted 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986.
Library of Congress Cataloging-in-Publication Data
Names: LoBiondo-Wood, Geri, editor. | Haber, Judith, editor. Title: Nursing research : methods and critical appraisal for evidence-based practice / [edited by] Geri LoBiondo-Wood, Judith Haber. Other titles: Nursing research (LoBiondo-Wood) Description: 9th edition. | St. Louis, Missouri : Elsevier, [2018] | Includes bibliographical references and index. Identifiers: LCCN 2017008727 | ISBN 9780323431316 (pbk. : alk. paper) Subjects: | MESH: Nursing Research—methods | Research Design | Evidence-Based Nursing—methods Classification: LCC RT81.5 | NLM WY 20.5 | DDC 610.73072—dc23 LC record available at https://lccn.loc.gov/2017008727
Executive Content Strategist: Lee Henderson Content Development Manager: Lisa Newton Content Development Specialist: Melissa Rawe Publishing Services Manager: Jeff Patterson Book Production Specialist: Carol O’Connell Design Direction: Renee Duenow
Printed in China
Last digit is the print number: 9 8 7 6 5 4 3 2 1
About the authors
Geri LoBiondo-Wood, PhD, RN, FAAN, is Professor and Coordinator of the PhD in Nursing Program at the University of Texas Health Science Center at Houston, School of Nursing (UTHSC-Houston) and former Director of Research and Evidence-Based Practice Planning and Development at the MD Anderson Cancer Center, Houston, Texas. She received her Diploma in Nursing at St. Mary’s Hospital School of Nursing in Rochester, New York; Bachelor’s and Master’s degrees from the University of Rochester; and a PhD in Nursing Theory and Research from New York University. Dr. LoBiondo-Wood teaches research and evidence-based practice principles to undergraduate, graduate, and doctoral students. At MD Anderson Cancer Center, she developed and implemented the Evidence-Based Resource Unit Nurse (EB-RUN) Program. She has extensive national and international experience guiding nurses and other health care professionals in the development and utilization of research. Dr. LoBiondo-Wood is an Editorial Board member of Progress in Transplantation and a reviewer for Nursing Research, Oncology Nursing Forum, and Oncology Nursing. Her research and publications focus on chronic illness and oncology nursing. Dr. Wood has received funding from the Robert Wood Johnson Foundation Future of Nursing Scholars program for the past several years to fund full-time doctoral students.
Dr. LoBiondo-Wood has been active locally and nationally in many professional organizations, including the Oncology Nursing Society, Southern Nursing Research Society, the Midwest Nursing Research Society, and the North American Transplant Coordinators Organization. She has received local and national awards for teaching and contributions to nursing. In 1997, she received the Distinguished Alumnus Award from New York University, Division of Nursing Alumni Association. In 2001 she was inducted as a Fellow of the American Academy of Nursing and in 2007 as a Fellow of the University of Texas Academy of Health Science Education. In 2012 she was appointed as a Distinguished Teaching Professor of the University of Texas System and in 2015 received the John McGovern Outstanding Teacher Award from the University of Texas Health Science Center at Houston School of Nursing.
Judith Haber, PhD, RN, FAAN, is the Ursula Springer Leadership Professor in Nursing at the Rory Meyers College of Nursing at New York University. She received her undergraduate nursing education at Adelphi University in New York, and she holds a Master’s degree in Adult Psychiatric–Mental Health Nursing and a PhD in Nursing Theory and Research from New York University. Dr. Haber is internationally recognized as a clinician and educator in psychiatric–mental health nursing. She was the editor of the award-winning classic textbook, Comprehensive Psychiatric Nursing, published for eight editions and translated into five languages. She has extensive clinical experience in psychiatric nursing, having been an advanced practice psychiatric nurse in private practice for over 30 years, specializing in treatment of families coping with the psychosocial impact of acute and chronic illness. Her NIH-funded program of research addressed physical and psychosocial adjustment to illness, focusing specifically on women with breast cancer and their partners and, more recently, breast cancer survivorship and lymphedema prevention and risk reduction. Dr. Haber is also committed to an interprofessional program of clinical scholarship related to interprofessional education and improving oral-systemic health outcomes and is the Executive Director of a national nursing oral health initiative, the Oral Health Nursing Education and Practice (OHNEP) program, funded by the DentaQuest and Washington Dental Service Foundations.
Dr. Haber is the recipient of numerous awards, including the 1995 and 2005 APNA Psychiatric Nurse of the Year Award, the 2005 APNA Outstanding Research Award, and the 1998 ANA Hildegarde Peplau Award. She received the 2007 NYU Distinguished Alumnae Award, the 2011 Distinguished Teaching Award, and the 2014 NYU Meritorious Service Award. In 2015, Dr. Haber received the Sigma Theta Tau International Marie Hippensteel Lingeman Award for Excellence in Nursing Practice. Dr. Haber is a Fellow in the American Academy of Nursing and the New York Academy of Medicine. Dr. Haber has consulted, presented, and published widely on evidence-based practice, interprofessional education and practice, as well as oral-systemic health issues.
Contributors
Terri Armstrong, PhD, ANP-BC, FAANP, Senior Investigator, Neuro-oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
Julie Barroso, PhD, ANP, RN, FAAN, Professor and Department Chair, Medical University of South Carolina, Charleston, South Carolina
Carol Bova, PhD, RN, ANP, Professor of Nursing and Medicine, Graduate School of Nursing, University of Massachusetts, Worcester, Massachusetts
Dona Rinaldi Carpenter, EdD, RN, Professor and Chair, University of Scranton, Department of Nursing, Scranton, Pennsylvania
Maja Djukic, PhD, RN, Assistant Professor, Rory Meyers College of Nursing, New York University, New York, New York
Mei R. Fu, PhD, RN, FAAN, Associate Professor, Rory Meyers College of Nursing, New York University, New York, New York
Mattia J. Gilmartin, PhD, RN, Senior Research Scientist , Executive Director, NICHE Program, Rory Meyers College of Nursing, New York University, New York, New York
Deborah J. Jones, PhD, MS, RN, Margaret A. Barnett/PARTNERS Professorship , Associate Dean for Professional Development and Faculty Affairs , Associate Professor, University of Texas Health Science Center at Houston, School of Nursing, Houston, Texas
Carl Kirton, DNP, RN, MBA, Chief Nursing Officer, University Hospital, Newark, New Jersey; , Adjunct Faculty, Rory Meyers College of Nursing, New York University, New York, New York
Barbara Krainovich-Miller, EdD, RN, PMHCNS-BC, ANEF, FAAN, Professor, Rory Meyers College of Nursing, New York University, New York, New York
Elaine Larson, PhD, RN, FAAN, CIC, Anna C. Maxwell Professor of Nursing Research , Associate Dean for Research, Columbia University School of Nursing, New York, New York
Melanie McEwen, PhD, RN, CNE, ANEF, Professor, University of Texas Health Science Center at Houston, School of Nursing, Houston, Texas
Gail D’Eramo Melkus, EdD, ANP, FAAN, Florence & William Downs Professor in Nursing Research, Associate Dean for Research, Rory Meyers College of Nursing, New York University, New York, New York
Susan Sullivan-Bolyai, DNSc, CNS, RN, FAAN, Associate Professor, Rory Meyers College of Nursing, New York University, New York, New York
Marita Titler, PhD, RN, FAAN, Rhetaugh G. Dumas Endowed Professor , Department Chair, Department of Systems, Populations and Leadership, University of Michigan School of Nursing, Ann Arbor, Michigan
Mark Toles, PhD, RN, Assistant Professor, University of North Carolina at Chapel Hill, School of Nursing, Chapel Hill, North Carolina
Reviewers Karen E. Alexander, PhD, RN, CNOR, Program Director RN-BSN, Assistant Professor, Department of Nursing, University of Houston Clear Lake-Pearland, Houston, Texas
Donelle M. Barnes, PhD, RN, CNE, Associate Professor, College of Nursing, University of Texas, Arlington, Arlington, Texas
Susan M. Bezek, PhD, RN, ACNP, CNE, Assistant Professor, Division of Nursing, Keuka College, Keuka Park, New York
Rose M. Kutlenios, PhD, MSN, MN, BSN, ANCC Board Certification, Adult Psychiatric/Mental Health Clinical Specialist, ANCC Board Certification, Adult Nurse Practitioner, Nursing Program Director and Associate Professor, Department of Nursing, West Liberty University, West Liberty, West Virginia
Shirley M. Newberry, PhD, RN, PHN, Professor, Department of Nursing, Winona State University, Winona, Minnesota
Sheryl Scott, DNP, RN, CNE, Assistant Professor and Chair, School of Nursing, Wisconsin Lutheran College, Milwaukee, Wisconsin
To the faculty Geri LoBiondo-Wood, Geri.L.Wood@uth.tmc.edu, Judith Haber, jh33@nyu.edu
The foundation of the ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice continues to be the belief that nursing research is integral to all levels of nursing education and practice. Over the past three decades since the first edition of this textbook, we have seen the depth and breadth of nursing research grow, with more nurses conducting research and using research evidence to shape clinical practice, education, administration, and health policy.
The National Academy of Medicine has challenged all health professionals to provide team-based care based on the best available scientific evidence. This is an exciting challenge. Nurses, as clinicians and interprofessional team members, are using the best available evidence, combined with their clinical judgment and patient preferences, to influence the nature and direction of health care delivery and document outcomes related to the quality and cost-effectiveness of patient care. As nurses continue to develop a unique body of nursing knowledge through research, decisions about clinical nursing practice will be increasingly evidence based.
As editors, we believe that all nurses need not only to understand the research process but also to know how to critically read, evaluate, and apply research findings in practice. We realize that understanding research, as a component of evidence-based practice and quality improvement practices, is a challenge for every student, but we believe that the challenge can be accomplished in a stimulating, lively, and learner-friendly manner.
Consistent with this perspective is an ongoing commitment to advancing implementation of evidence-based practice. Understanding and applying research must be an integral dimension of baccalaureate education, evident not only in the undergraduate nursing research course but also threaded throughout the curriculum. The research role of baccalaureate graduates calls for evidence-based practice and quality improvement competencies; central to this are critical appraisal skills—that is, nurses should be competent research consumers.
Preparing students for this role involves developing their critical thinking skills, thereby enhancing their understanding of the research process, their appreciation of the role of the critiquer, and their ability to actually critically appraise research. An undergraduate research course should develop this basic level of competence, an essential requirement if students are to engage in evidence-informed clinical decision making and practice, as well as quality improvement activities.
The primary audience for this textbook remains undergraduate students who are learning the steps of the research process, as well as how to develop clinical questions, critically appraise published research literature, and use research findings to inform evidence-based clinical practice and quality improvement initiatives. This book is also a valuable resource for students at the master’s, DNP, and PhD levels who want a concise review of the basic steps of the research process, the critical appraisal process, and the principles and tools for evidence-based practice and quality improvement.
This text is also an important resource for practicing nurses who strive to use research evidence as the basis for clinical decision making and development of evidence-based policies, protocols, and standards or who collaborate with nurse-scientists in conducting clinical research and evidence-based practice. Finally, this text is an important resource for considering how evidence-based practice, quality improvement, and interprofessional collaboration are essential competencies for students and clinicians practicing in a transformed health care system, where nurses and their interprofessional team members are accountable for the quality and cost-effectiveness of care provided to their patient population. Building on the success of the eighth edition, we reaffirm our commitment to introducing evidence-based practice, quality improvement processes, and research principles to baccalaureate students, thereby providing a cutting-edge, research consumer foundation for their clinical practice. Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice prepares nursing students and practicing nurses to become knowledgeable nursing research consumers by doing the following:
• Addressing the essential evidence-based practice and quality improvement role of the nurse, thereby embedding evidence-based competencies in clinical practice.
• Demystifying research, which is sometimes viewed as a complex process.
• Using a user-friendly, evidence-based approach to teaching the fundamentals of the research process.
• Including an exciting chapter on the role of theory in research and evidence-based practice.
• Providing a robust chapter on systematic reviews and clinical guidelines.
• Offering two innovative chapters on current strategies and tools for developing an evidence-based practice.
• Concluding with an exciting chapter on quality improvement and its application to practice.
• Teaching the critical appraisal process in a user-friendly progression.
• Promoting a lively spirit of inquiry that develops critical thinking and critical reading skills, facilitating mastery of the critical appraisal process.
• Developing information literacy, searching, and evidence-based practice competencies that prepare students and nurses to effectively locate and evaluate the best research evidence.
• Emphasizing the role of evidence-based practice and quality improvement initiatives as the basis for informing clinical decisions that support nursing practice.
• Presenting numerous examples of recently published research studies that illustrate and highlight research concepts in a manner that
brings abstract ideas to life for students. These examples are critical links that reinforce evidence-based concepts and the critiquing process.
• Presenting five published articles, including a meta-analysis, in the Appendices, the highlights of which are woven throughout the text as exemplars of research and evidence-based practice.
• Showcasing, in four new inspirational Research Vignettes, the work of renowned nurse researchers whose careers exemplify the links among research, education, and practice.
• Introducing new pedagogical interprofessional education chapter features, IPE Highlights and IPE Critical Thinking Challenges and quality improvement, QSEN Evidence-Based Practice Tips.
• Integrating stimulating pedagogical chapter features that reinforce learning, including Learning Outcomes, Key Terms, Key Points, Critical Thinking Challenges, Helpful Hints, Evidence-Based Practice Tips, Critical Thinking Decision Paths, and numerous tables, boxes, and figures.
• Featuring a revised section titled Appraising the Evidence, accompanied by an updated Critiquing Criteria box in each chapter that presents a step of the research process.
• Offering a student Evolve site with interactive review questions that provide chapter-by-chapter review in a format consistent with that of the NCLEX® Examination.
• Offering a Student Study Guide that promotes active learning and assimilation of nursing research content.
• Presenting Faculty Evolve Resources that include a test bank, TEACH lesson plans, PowerPoint slides with integrated audience response system questions, and an image collection. Evolve resources for both students and faculty also include a research article library with appraisal exercises for additional practice in reviewing and critiquing, as well as content updates.
The ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice is organized into four parts. Each part is preceded by an introductory section and opens with an engaging Research Vignette by a renowned nurse researcher.
Part I, Overview of Research and Evidence-Based Practice, contains four chapters: Chapter 1, “Integrating Research, Evidence-Based Practice, and Quality Improvement Processes,” provides an excellent overview of research and evidence-based practice processes that shape clinical practice. The chapter speaks directly to students and highlights critical reading concepts and strategies, facilitating student understanding of the research process and its relationship to the critical appraisal process. The chapter introduces a model evidence hierarchy that is used throughout the text. The style and content of this chapter are designed to make subsequent chapters user friendly. The next two chapters address foundational components of the research process. Chapter 2, “Research Questions, Hypotheses, and Clinical Questions,” focuses on how research questions and hypotheses are derived, operationalized, and critically appraised. Students are also taught how to develop clinical questions that are used to guide evidence-based inquiry, including quality improvement projects. Chapter 3, “Gathering and Appraising the Literature,” showcases cutting-edge information literacy content and provides students and nurses with the tools necessary to effectively search, retrieve, manage, and evaluate research studies and their findings. Chapter 4, “Theoretical Frameworks for Research,” is a user-friendly theory chapter that provides students with an understanding of how theories provide the foundation of research studies and evidence-based practice projects.
Part II, Processes and Evidence Related to Qualitative Research, contains three interrelated qualitative research chapters. Chapter 5, “Introduction to Qualitative Research,” provides an exciting framework for understanding qualitative research and the significant contribution of qualitative research to evidence-based practice. Chapter 6, “Qualitative Approaches to Research,” presents, illustrates, and showcases major qualitative methods using examples from the literature as exemplars. This chapter highlights the questions most appropriately answered using qualitative methods. Chapter 7, “Appraising Qualitative Research,” synthesizes essential components of and criteria for critiquing qualitative research reports using published qualitative research study.
Part III, Processes and Evidence Related to Quantitative Research, contains Chapters 8 to 18Chapter 8Chapter 9Chapter 10Chapter 11Chapter 12Chapter 13Chapter 14Chapter 15Chapter 16Chapter 17Chapter 18. This group of chapters delineates essential steps of the quantitative research process, with published clinical research studies used to illustrate each step. These chapters are streamlined to make the case for linking an evidence-based approach with essential steps of the research process. Students are taught how to critically appraise the strengths and weaknesses of each step of the research process in a synthesized critique of a study. The steps of the quantitative research process, evidence-based concepts, and critical appraisal criteria are synthesized in Chapter 18 using two published research studies, providing a model for appraising strengths and weaknesses of studies, and determining applicability to practice. Chapter 11, a unique chapter, addresses the use of the types of systematic reviews that support an evidence-based practice as well as the development and application of clinical guidelines.
Part IV, Application of Research: Evidence-Based Practice, contains three chapters that showcase evidence-based practice models and tools. Chapter 19, “Strategies and Tools for Developing an Evidence-Based Practice,” is a revised, vibrant, user-friendly, evidence-based toolkit with exemplars that capture the essence of high-quality, evidence-informed nursing care. It “walks” students and practicing nurses through clinical scenarios and challenges them to consider the relevant evidence-based practice “tools” to develop and answer questions that emerge from clinical situations. Chapter 20, “Developing an Evidence-Based Practice,” offers a dynamic presentation of important evidence- based practice models that promote evidence-based decision making. Chapter 21, “Quality Improvement,” is an innovative, engaging chapter that outlines the quality improvement process with information from current guidelines. Together, these chapters provide an inspirational conclusion to a text that we hope motivates students and practicing nurses to advance their evidence-based practice and quality improvement knowledge base and clinical competence, positioning them to make important contributions to improving health care outcomes as essential members of interprofessional teams.
Stimulating critical thinking is a core value of this text. Innovative chapter features such as Critical Thinking Decision Paths, Evidence- Based Practice Tips, Helpful Hints, Critical Thinking Challenges, IPE Highlights, and QSEN Evidence-Based Practice Tips enhance critical thinking, promote the development of evidence-based decision-making skills, and cultivate a positive value about the importance of collaboration in promoting evidence-based, high quality and cost-effective clinical outcomes.
Consistent with previous editions, we promote critical thinking by including sections called “Appraising the Evidence,” which describe the critical appraisal process related to the focus of the chapter. Critiquing Criteria are included in this section to stimulate a systematic and
evaluative approach to reading and understanding qualitative and quantitative research and evaluating its strengths and weaknesses. Extensive resources are provided on the Evolve site that can be used to develop critical thinking and evidence-based competencies.
The development and refinement of an evidence-based foundation for clinical nursing practice is an essential priority for the future of professional nursing practice. The ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice will help students develop a basic level of competence in understanding the steps of the research process that will enable them to critically analyze research studies, judge their merit, and judiciously apply evidence in clinical practice. To the extent that this goal is accomplished, the next generation of nursing professionals will have a cadre of clinicians who inform their practice using theory, research evidence, and clinical judgment, as they strive to provide high-quality, cost-effective, and satisfying health care experiences in partnership with individuals, families, and communities.
To the student Geri LoBiondo-Wood, Geri.L.Wood@uth.tmc.edu, Judith Haber, jh33@nyu.edu
We invite you to join us on an exciting nursing research adventure that begins as you turn the first page of the ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice. The adventure is one of discovery! You will discover that the nursing research literature sparkles with pride, dedication, and excitement about the research dimension of professional nursing practice. Whether you are a student or a practicing nurse whose goal is to use research evidence as the foundation of your practice, you will discover that nursing research and a commitment to evidence-based practice positions our profession at the forefront of change. You will discover that evidence-based practice is integral to being an effective member of an interprofessional team prepared to meet the challenge of providing quality whole person care in partnership with patients, their families/significant others, as well as with the communities in which they live. Finally, you will discover the richness in the “Who,” “What,” “Where,” “When,” “Why,” and “How” of nursing research and evidence- based practice, developing a foundation of knowledge and skills that will equip you for clinical practice and making a significant contribution to achieving the Triple Aim, that is, contributing to high quality and cost-effective patient outcomes associated with satisfying patient experiences!
We think you will enjoy reading this text. Your nursing research course will be short but filled with new and challenging learning experiences that will develop your evidence-based practice skills. The ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice reflects cutting-edge trends for developing evidence-based nursing practice. The four-part organization and special features in this text are designed to help you develop your critical thinking, critical reading, information literacy, interprofessional, and evidence-based clinical decision-making skills, while providing a user-friendly approach to learning that expands your competence to deal with these new and challenging experiences. The companion Study Guide, with its chapter-by-chapter activities, serves as a self-paced learning tool to reinforce the content of the text. The accompanying Evolve website offers review questions to help you reinforce the concepts discussed throughout the book.
Remember that evidence-based practice skills are used in every clinical setting and can be applied to every patient population or clinical practice issue. Whether your clinical practice involves primary care or critical care and provides inpatient or outpatient treatment in a hospital, clinic, or home, you will be challenged to apply your evidence-based practice skills and use nursing research as the foundation for your evidence-based practice. The ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice will guide you through this exciting adventure, where you will discover your ability to play a vital role in contributing to the building of an evidence-based professional nursing practice.
Acknowledgments Geri LoBiondo-Wood, Judith Haber
No major undertaking is accomplished alone; there are those who contribute directly and those who contribute indirectly to the success of a project. We acknowledge with deep appreciation and our warmest thanks the help and support of the following people:
• Our students, particularly the nursing students at the University of Texas Health Science Center at Houston School of Nursing and the Rory Meyers College of Nursing at New York University, whose interest, lively curiosity, and challenging questions sparked ideas for revisions in the ninth edition.
• Our chapter contributors, whose passion for research, expertise, cooperation, commitment, and punctuality made them a joy to have as colleagues.
• Our vignette contributors, whose willingness to share evidence of their research wisdom made a unique and inspirational contribution to this edition.
• Our colleagues, who have taken time out of their busy professional lives to offer feedback and constructive criticism that helped us prepare this ninth edition.
• Our editors, Lee Henderson, Melissa Rawe, and Carol O’Connell, for their willingness to listen to yet another creative idea about teaching research in a meaningful way and for their expert help with manuscript preparation and production.
• Our families: Rich Scharchburg; Brian Wood; Lenny, Andrew, Abbe, Brett, and Meredith Haber; and Laurie, Bob, Mikey, Benjy, and Noah Goldberg for their unending love, faith, understanding, and support throughout what is inevitably a consuming—but exciting— experience.
PA R T I Overview of Research and Evidence-Based Practice
Research Vignette: Terri Armstrong
OUTLINE
Introduction
1. Integrating research, evidence-based practice, and quality improvement processes
2. Research questions, hypotheses, and clinical questions
3. Gathering and appraising the literature
4. Theoretical frameworks for research
Introduction
Research vignette
With a little help from my friends Terri Armstrong, PhD ANP-BC, FAANP, FAAN
Senior Investigator Neuro-Oncology Branch National Cancer Institute National Institute of Health Bethesda, Maryland I grew up surrounded by family and strong role models of women working in health care in a small town in Ohio. When in college, the
three most important women in my life (my mom, grandmother, and great-grandmother) were all diagnosed with cancer. This led me to seek out a nursing position in oncology, and over time, I was able to be actively involved in their care. This experience taught me so much and led to the desire to do more to make the daily lives of people with cancer better. After obtaining a master’s in oncology and a postmaster’s nurse practitioner, an opportunity to work with Dr. M. Gilbert, a well-known caring physician who specialized in the care and treatment of patients with central nervous system (CNS) tumors and a great mentor, became available, so my work with people with CNS tumors began.
After several years, I realized that the quality of life of the brain tumor patients and families was significantly impacted by the symptoms they experienced. Over 80% were unable to return to work from the time of diagnosis, and their daily lives (and those of their families) were often consumed with managing the neurologic and treatment-related symptoms. I realized that obtaining my PhD would be an important step to learn the skills I would need to try to find answers to solve the problems CNS tumor patients were facing.
At that time, many of the conceptual models identified solitary symptoms and their impact on the person. I learned from my experience and in caring for patients that symptoms seldom occurred in isolation and that the meaning the symptoms had for patients’ daily lives was important, as was learning about the patients’ perception of that impact. I developed a conceptual model to identify those relationships and guide my research (Armstrong, 2003). My focus since then has been on patient-centered outcomes research, focusing on the impact of symptoms on the illness trajectory, tolerance of therapy, and potential to influence survival. My work is never done in isolation. I have been fortunate to work with research teams, including those who work alongside me and important collaborators across disciplines and the world. Team research, in which the views of various disciplines are brought together, is important in every step of research—from the hypothesis to study design and finally interpretation of the results.
My work is interconnected, but I believe it can be categorized into three general areas:
1. Improving assessment and our understanding of the experience of patients with CNS tumors.
Patients with primary brain tumors are highly symptomatic, with implications for functional status, and are used in making treatment decisions. I led a team that developed the M.D. Anderson Symptom Inventory for Brain Tumors (MDASI-BT) (Armstrong et al., 2005; Armstrong et al., 2006) and spinal cord tumors (MDASI-Spine) (Armstrong, Gning, et al., 2010). We have completed studies showing that symptoms are associated with tumor progression (Armstrong et al., 2011). We have also been able to quantify limitations of patients’ functional status (Armstrong et al., 2015), in a way that caregivers report is congruent with the patient, and have found that electronic technology (such as iPads) can be used for this (Armstrong et al., 2012). Our work with the Collaborative Ependymoma Research Organization (CERN, www.cern-foundation.org) has allowed us to reach out to patients with this rarer tumor to understand the natural history and impact of the disease and its treatment on patients around the world (Armstrong, Vera-Bolanos, et al., 2010; Armstrong, Vera- Bolanos, & Gilbert, 2011). Based on these surveys, we have developed materials to inform patients and are launching an expansion of this project, in which we will evaluate risk factors (both based on history and genetics) for the occurrence of these tumors in both adults and children.
2. Incorporation of clinical outcomes assessment into brain tumor clinical trials.
Clinical trials often assess the impact of therapy on how the tumor appears on imaging or survival, but the impact on the person is often not assessed. I have been fortunate to work with Dr. M. Gilbert and Dr. J. Wefel to incorporate these outcomes into large clinical trials, providing clear evidence that it was feasible to incorporate patient outcomes measures and that the results of these evaluations could impact the interpretation of the clinical trial (Armstrong et al., 2013; Gilbert et al., 2014). As a result of my involvement in these efforts, I recently chaired a daylong workshop exploring the use of clinical outcomes assessments (COAs) in brain tumor trials, a workshop cosponsored by the FDA and the Jumpstarting Brain Tumor Drug Development (JSBTDD) consortia that also included members of the academic community, patient advocates, pharmaceutical industry, and the NIH. This successful workshop has resulted in a series of white papers that were recently published on the importance of including these in clinical trials (Armstrong, Bishof, et al., 2016; Helfer et al., 2016).
3. Identification of clinical and genomic predictors of toxicity.
Toxicity associated with treatment also impacts the patient. For example, Temozolomide, the most common agent used in the treatment of brain tumors, has a low overall incidence of myelotoxicity (impact on blood counts that help to fight infection or clot the blood). However, in the select patients who develop toxicity, there are significant clinical implications (treatment holds or cessation, and even death). I work with an interdisciplinary group that began to explore the clinical predictors of this toxicity and then explored associated genomic changes associated with risk (Armstrong et al., 2009). Currently, I am also working with a research team exploring risk factors and pathogenesis of radiation-induced fatigue and sleepiness, which is a major symptom in a large percentage of patients undergoing cranial radiotherapy for their brain tumor (Armstrong, Shade, et al., 2016). The ultimate goal of this part of my research is to begin to uncover phenotypes
associated with symptoms and to uncover the underlying biologic processes, so that we can initiate measures prior to the occurrence of symptoms, rather than waiting for them to occur and then trying to mitigate them.
In addition to conducting focused outcomes research as outlined previously, I have over 25 years’ dedication to the clinical care of persons with tumors of the CNS. This work is the best part of my job and is a critical linkage and inspiration in my research, with the goal of improving the daily life of patients and improving our understanding of the underlying biology of symptoms and experience that our patients have.
References 1. Armstrong T. S. Symptoms experience a concept analysis. Oncology Nursing Society 2003;30(4):601-606. 2. Armstrong T. S, Cohen M. Z, Eriksen L., Cleeland C. Content validity of self-report measurement instruments an illustration from the
development of the Brain Tumor Module of the M. D. Anderson Symptom Inventory. Oncology Nursing Society 2005;32(3):669-676. 3. Armstrong T. S, Mendoza T., Gning I., et al. Validation of the M. D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT).
Journal of Neuro-Oncology 2006;80(1):27-35. 4. Armstrong T. S, Cao Y., Scheurer M. E, et al. Risk analysis of severe myelotoxicity with temozolomide The effects of clinical and genetic
factors. Neuro-Oncology 2009;11(6):825-832. 5. Armstrong T. S, Gning I., Mendoza T. R, et al. Reliability and validity of the M. D. Anderson Symptom Inventory-Spine Tumor Module.
Journal of Neurosurgery Spine 2010;12(4):421-430. 6. Armstrong T. S, Vera-Bolanos E., Bekele B. N, et al. Adult ependymal tumors prognosis and the M. D. Anderson Cancer Center
experience. Neuro-Oncology 2010;12(8):862-870. 7. Armstrong T. S, Vera-Bolanos E., Gilbert M. R. Clinical course of adult patients with ependymoma results of the Adult Ependymoma
Outcomes Project. Cancer 2011;117(22):5133-5141. 8. Armstrong T. S, Vera-Bolanos E., Gning I., et al. The impact of symptom interference using the MD Anderson Symptom Inventory-Brain
Tumor Module (MDASI-BT) on prediction of recurrence in primary brain tumor patients. Cancer 2011;117(14):3222-3228. 9. Armstrong T. S, Wefel J. S, Gning I., et al. Congruence of primary brain tumor patient and caregiver symptom report. Cancer
2012;118(20):5026-5037. 10. Armstrong T. S, Wefel J. S, Wang M., et al. Net clinical benefit analysis of radiation therapy oncology group 0525 a phase III trial
comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma. Journal of Clinical Oncology 2013;31(32):4076-4084.
11. Armstrong T. S, Vera-Bolanos E., Acquaye A. A, et al. The symptom burden of primary brain tumors evidence for a core set of tumor and treatment-related symptoms. Neuro-Oncology 2015;18(2):252-260 Epub August 19, 2015.
12. Armstrong T. S, Bishof A. M, Brown P. D, et al. Determining priority signs and symptoms for use as clinical outcomes assessments in trials including patients with malignant gliomas panel 1 report. Neuro-Oncology 2016;18(Suppl. 2):ii1-ii12.
13. Armstrong T. S, Shade M. Y, Breton G., et al. Sleep-wake disturbance in patients with brain tumors.;: Neuro-Oncology, in press2016; 14. Gilbert M. R, Dignam J. J, Armstrong T. S, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. New England Journal
of Medicine 2014;370(8):699-708. 15. Helfer J. L, Wen P. Y, Blakeley J., et al. Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical
outcome assessment endpoints workshop (October 15, 2014, Bethesda, MD). Neuro-Oncology 2016;18(Suppl. 2):ii26-ii36.
C H A P T E R 1
Integrating research, evidence-based practice, and quality improvement processes Geri LoBiondo-Wood, Judith Haber
Learning outcomes
After reading this chapter, you should be able to do the following: • State the significance of research, evidence-based practice, and quality improvement (QI). • Identify the role of the consumer of nursing research. • Define evidence-based practice. • Define QI. • Discuss evidence-based and QI decision making. • Explain the difference between quantitative and qualitative research. • Explain the difference between the types of systematic reviews. • Identify the importance of critical reading skills for critical appraisal of research. • Discuss the format and style of research reports/articles. • Discuss how to use an evidence hierarchy when critically appraising research studies.
KEY TERMS
abstract clinical guidelines consensus guidelines critical appraisal critical reading critique evidence-based guidelines evidence-based practice integrative review levels of evidence meta-analysis meta-synthesis quality improvement qualitative research quantitative research research systematic review
Go to Evolve at http://evolve.elsevier.com/LoBiondo/ for review questions, critiquing exercises, and additional research articles for practice in reviewing and critiquing.
We invite you to join us on an exciting nursing research adventure that begins as you read the first page of this chapter. The adventure is one of discovery! You will discover that the nursing research literature sparkles with pride, dedication, and excitement about this dimension of professional practice. As you progress through your educational program, you are taught how to ensure quality and safety in practice through acquiring knowledge of the various sciences and health care principles. A critical component of clinical knowledge is understanding research as it applies to practicing from a base of evidence.
Whether you are a student or a practicing nurse whose goal is to use research as the foundation of your practice, you will discover that research, evidence-based practice, and quality improvement (QI) positions our profession at the cutting edge of change and improvement in patient outcomes. You will also discover the cutting edge “who,” “what,” “where,” “when,” “why,” and “how” of nursing research, and develop a foundation of evidence-based practice knowledge and competencies that will equip you for your clinical practice.
Your nursing research adventure will be filled with new and challenging learning experiences that develop your evidence-based practice skills. Your critical thinking, critical reading, and clinical decision-making skills will expand as you develop clinical questions, search the research literature, evaluate the research evidence found in the literature, and make clinical decisions about applying the “best available evidence” to your practice. For example, you will be encouraged to ask important clinical questions, such as, “What makes a telephone
education intervention more effective with one group of patients with a diagnosis of congestive heart failure but not another?” “What is the effect of computer learning modules on self-management of diabetes in children?” “What research has been conducted in the area of identifying barriers to breast cancer screening in African American women?” “What is the quality of studies conducted on telehealth?” “What nursing-delivered smoking cessation interventions are most effective?” This book will help you begin your adventure into evidence- based practice by developing an appreciation of research as the foundation for evidence-based practice and QI.
Nursing research, evidence-based practice, and quality improvement Nurses are challenged to stay abreast of new information to provide the highest quality of patient care (Institute of Medicine [IOM], 2011). Nurses are challenged to expand their “comfort zone” by offering creative approaches to old and new health problems, as well as designing new and innovative programs that make a difference in the health status of our citizens. This challenge can best be met by integrating rapidly expanding research and evidence-based knowledge about biological, behavioral, and environmental influences on health into the care of patients and their families.
It is important to differentiate between research, evidence-based practice, and QI. Research is the systematic, rigorous, critical investigation that aims to answer questions about nursing phenomena. Researchers follow the steps of the scientific process, outlined in this chapter and discussed in detail in each chapter of this textbook. There are two types of research: quantitative and qualitative. The methods used by nurse researchers are the same methods used by other disciplines; the difference is that nurses study questions relevant to nursing practice. Published research studies are read and evaluated for use in clinical practice. Study findings provide evidence that is evaluated, and applicability to practice is used to inform clinical decisions.
Evidence-based practice is the collection, evaluation, and integration of valid research evidence, combined with clinical expertise and an understanding of patient and family values and preferences, to inform clinical decision making (Sackett et al., 2000). Research studies are gathered from the literature and assessed so that decisions about application to practice can be made, culminating in nursing practice that is evidence based. ➤ Example: To help you understand the importance of evidence-based practice, think about the systematic review and meta-analysis from Al-Mallah and colleagues (2015), which assessed the impact of nurse-led clinics on the mortality and morbidity of patients with cardiovascular disease (see Appendix E). Based on their synthesis of the literature, they put forth several conclusions regarding the implications for practice and further research for nurses working in the field of cardiovascular care.
QI is the systematic use of data to monitor the outcomes of care processes as well as the use of improvement methods to design and test changes in practice for the purpose of continuously improving the quality and safety of health care systems (Cronenwett et al., 2007). While research supports or generates new knowledge, evidence-based practice and QI uses currently available knowledge to improve health care delivery. When you first read about these three processes, you will notice they have similarities. Each begins with a question. The difference is that in a research study the question is tested with a design appropriate to the question and specific methodology (i.e., sample, instruments, procedures, and data analysis) used to test the research question and contribute to new, generalizable knowledge. In the evidence-based practice and QI processes, a question is used to search the literature for already completed studies in order to bring about improvements in care.
All nurses share a commitment to the advancement of nursing science by conducting research and using research evidence in practice. Research promotes accountability, which is one of the hallmarks of the nursing profession and a fundamental concept of the American Nurses Association (ANA) Code for Nurses (ANA, 2015). There is a consensus that the research role of the baccalaureate and master’s graduate calls for critical appraisal skills. That is, nurses must be knowledgeable consumers of research, who can evaluate the strengths and weaknesses of research evidence and use existing standards to determine the merit and readiness of research for use in clinical practice. Therefore, to use research for an evidence-based practice and to practice using the highest quality processes, you do not have to conduct research; however, you do need to understand and appraise the steps of the research process in order to read the research literature critically and use it to inform clinical decisions.
As you venture through this text, you will see the steps of the research, evidence-based practice, and QI processes. The steps are systematic and relate to the development of evidence-based practice. Understanding the processes that researchers use will help you develop the assessment skills necessary to judge the soundness of research studies.
throughout the chapters, terminology pertinent to each step is identified and illustrated with examples. Five published studies are found in the appendices and used as examples to illustrate significant points in each chapter. Judging the study’s strength and quality, as well as its applicability to practice, is key. Before you can judge a study, it is important to understand the differences among studies. There are different study designs that you will see as you read through this text and the appendices. There are standards not only for critiquing the soundness of each step of a study, but also for judging the strength and quality of evidence provided by a study and determining its applicability to practice.
This chapter provides an overview of research study designs and appraisal skills. It introduces the overall format of a research article and provides an overview of the subsequent chapters in the book. It also introduces the QI and evidence-based practice processes, a level of evidence hierarchy model, and other tools for helping you evaluate the strength and quality of research evidence. These topics are designed to help you read research articles more effectively and with greater understanding, so that you can make evidence-based clinical decisions and contribute to quality and cost-effective patient outcomes.
Types of research: Qualitative and quantitative Research is classified into two major categories: qualitative and quantitative. A researcher chooses between these categories based on the question being asked. That is, a researcher may wish to test a cause-and-effect relationship, or to assess if variables are related, or may wish to discover and understand the meaning of an experience or process. A researcher would choose to conduct a qualitative research study if the question is about understanding the meaning of a human experience such as grief, hope, or loss. The meaning of an experience is based on the view that meaning varies and is subjective. The context of the experience also plays a role in qualitative research. That is, the experience of loss as a result of a miscarriage would be different than the experience of losing a parent.
Qualitative research is generally conducted in natural settings and uses data that are words or text rather than numeric to describe the experiences being studied. Qualitative studies are guided by research questions, and data are collected from a small number of subjects, allowing an in-depth study of a phenomenon. ➤ Example: vanDijk et al. (2016) explored how patients assign a number to their postoperative pain experience (see Appendix C). Although qualitative research is systematic in its method, it uses a subjective approach. Data from qualitative studies help nurses understand experiences or phenomena that affect patients; these data also assist in generating theories that lead clinicians to develop improved patient care and stimulate further research. Highlights of the general steps of qualitative studies and the journal format for a qualitative article are outlined in Table 1.1. Chapters 5 through 7 provide an in-depth view of qualitative
research underpinnings, designs, and methods.
TABLE 1.1 Steps of the Research Process and Journal Format: Qualitative Research
Research Process Steps and/or Format Issues Usual Location in Journal Heading or Subheading Identifying the phenomenon Abstract and/or in introduction Research question study purpose Abstract and/or in beginning or end of introduction Literature review Introduction and/or discussion Design Abstract and/or in introductory section or under method section entitled “Design” or stated in method section Sample Method section labeled “Sample” or “Subjects” Legal-ethical issues Data collection or procedures section or in sample section Data collection procedure Data collection or procedures section Data analysis Methods section under subhead “Data Analysis” or “Data Analysis and Interpretation” Results Stated in separate heading: “Results” or “Findings” Discussion and recommendation Combined in separate section: “Discussion” or “Discussion and Implications” References At end of article
Whereas qualitative research looks for meaning, quantitative research encompasses the study of research questions and/or hypotheses that describe phenomena, test relationships, assess differences, seek to explain cause-and-effect relationships between variables, and test for intervention effectiveness. The numeric data in quantitative studies are summarized and analyzed using statistics. Quantitative research techniques are systematic, and the methodology is controlled. Appendices A, B, and D illustrate examples of different quantitative approaches to answering research questions. Table 1.2 indicates where each step of the research process can usually be located in a quantitative research article and where it is discussed in this text. Chapters 2, 3, and 8 through 18 describe processes related to quantitative research.
TABLE 1.2 Steps of the Research Process and Journal Format: Quantitative Research
Research Process Steps and/or Format Issue
Usual Location in Journal Heading or Subheading Text Chapter
Research problem Abstract and/or in article introduction or separately labeled: “Problem” 2 Purpose Abstract and/or in introduction, or end of literature review or theoretical framework section, or labeled separately: “Purpose” 2 Literature review At end of heading “Introduction” but not labeled as such, or labeled as separate heading: “Literature Review,” “Review of the Literature,” or “Related Literature”; or not
labeled or variables reviewed appear as headings or subheadings 3
TF and/or CF Combined with “Literature Review” or found in separate section as TF or CF; or each concept used in TF or CF may appear as separate subheading 3, 4 Hypothesis/research questions Stated or implied near end of introduction, may be labeled or found in separate heading or subheading: “Hypothesis” or “Research Questions”; or reported for first time
in “Results” 2
Research design Stated or implied in abstract or introduction or in “Methods” or “Methodology” section 8–10 Sample: type and size “Size” may be stated in abstract, in methods section, or as separate subheading under methods section as “Sample,” “Sample/Subjects,” or “Participants”; “Type” may be
implied or stated in any of previous headings described under size 12
Legal-ethical issues Stated or implied in sections: “Methods,” “Procedures,” “Sample,” or “Subjects” 13 Instruments Found in sections: “Methods,” “Instruments,” or “Measures” 14 Validity and reliability Specifically stated or implied in sections: “Methods,” “Instruments,” “Measures,” or “Procedures” 15 Data collection procedure In methods section under subheading “Procedure” or “Data Collection,” or as separate heading: “Procedure” 14 Data analysis Under subheading: “Data Analysis” 16 Results Stated in separate heading: “Results” 16, 17 Discussion of findings and new findings
Combined with results or as separate heading: “Discussion” 17
Implications, limitations, and recommendations
Combined in discussion or as separate major headings 17
References At end of article 4 Communicating research results Research articles, poster, and paper presentations 1, 20
CF, Conceptual framework; TF, theoretical framework.
The primary difference is that a qualitative study seeks to interpret meaning and phenomena, whereas quantitative research seeks to test a hypothesis or answer research questions using statistical methods. Remember as you read research articles that, depending on the nature of the research problem, a researcher may vary the steps slightly; however, all of the steps should be addressed systematically.
Critical reading skills To develop an expertise in evidence-based practice, you will need to be able to critically read all types of research articles. As you read a research article, you may be struck by the difference in style or format of a research article versus a clinical article. The terms of a research article are new, and the content is different. You may also be thinking that the research article is hard to read or that it is technical and boring. You may simultaneously wonder, “How will I possibly learn to appraise all the steps of a research study, the terminology, and the process of evidence-based practice? I’m only on Chapter 1. This is not so easy; research is as hard as everyone says.”
Remember that learning occurs with time and help. Reading research articles can be difficult and frustrating at first, but the best way to become a knowledgeable research consumer is to use critical reading skills when reading research articles. As a student, you are not expected to understand a research article or critique it perfectly the first time. Nor are you expected to develop these skills on your own. An essential objective of this book is to help you acquire critical reading skills so that you can use research in your practice. Becoming a competent critical thinker and reader of research takes time and patience.
Learning the research process further develops critical appraisal skills. You will gradually be able to read a research article and reflect on it by identifying assumptions, key concepts, and methods, and determining whether the conclusions are based on the study’s findings. Once you have obtained this critical appraisal competency, you will be ready to synthesize the findings of multiple studies to use in developing an evidence-based practice. This will be a very exciting and rewarding process for you. Analyzing a study critically can require several readings. As you review and synthesize a study, you will begin an appraisal process to help you determine the study’s worth. An illustration of how to use critical reading strategies is provided in Box 1.1, which contains an excerpt from the abstract, introduction, literature review, theoretical framework literature, and methods and procedure section of a quantitative study (Nyamathi et al., 2015) (see Appendix A). Note that in this article there is both a literature review and a theoretical framework section that clearly support the study’s objectives and purpose. Also note that parts of the text from the article were deleted to offer a number of examples within the text of this chapter. BOX 1.1
E x a m p l e o f C r i t i c a l A p p r a i s a l R e a d i n g S t r a t e g i e s Introductory Globally, incarcerated populations encounter a host of public health care issues; two such issues—HAV and HBV diseases—are vaccine preventable. In addition, viral hepatitis disproportionately
Paragraphs, Study’s Purpose and Aims
impacts the homeless because of increased risky sexual behaviors and drug use (Stein, Andersen, Robertson, & Gelberg, 2012), along with substandard living conditions (Hennessey, Bangsberg, Weinbaum, & Hahn, 2009).
Purpose—Despite knowledge of awareness of risk factors for HBV infection, intervention programs designed to enhance completion of the three-series Twinrix HAV/HBV vaccine and identification of prognostic factors for vaccine completion have not been widely studied. The purpose of this study was to first assess whether seronegative parolees previously randomized to any one of three intervention conditions were more likely to complete the vaccine series as well as to identify the predictors of HAV/HBV vaccine completion.
Literature Review— Concepts
Despite the availability of the HBV vaccine, there has been a low rate of completion for the three-dose core of the accelerated vaccine series (Centers for Disease Control and Prevention, 2012). Among incarcerated populations, HBV vaccine coverage is low; in a study among jail inmates, 19% had past HBV infection, and 12% completed the HBV vaccination series (Hennessey, Kim, et al., 2009). Although HBV is well accepted behind bars—because of the lack of funding and focus on prevention as a core in the prison system—few inmates complete the series (Weinbaum, Sabin, & Santibanez, 2005). In addition, prevention may not be priority.Preventable
disease vaccinations Homelessness
Authors contend that, although the HBV vaccine is cost-effective, it is underutilized among high-risk (Rich et al., 2003) and incarcerated populations (Hunt & Saab, 2009). For homeless men on parole, vaccination completion may be affected by level of custody; generally, the higher the level of custody, the higher the risk an inmate poses.
Conceptual Framework
The comprehensive health seeking and coping paradigm (Nyamathi, 1989), adapted from a coping model (Lazarus & Folkman, 1984), and the health seeking and coping paradigm (Schlotfeldt, 1981) guided this study and the variables selected (see Fig. 1.1). The comprehensive health seeking and coping paradigm has been successfully applied by our team to improve our understanding of HIV and HBV/hepatitis C virus (HCV) protective behaviors and health outcomes among homeless adults (Nyamathi, Liu, et al., 2009)—many of whom had been incarcerated (Nyamathi et al., 2012).
Methods/Design The study used a randomized clinical trial. Specific Aims and Hypotheses
In this model, a number of factors are thought to relate to the outcome variable, completion of the HAV/HBV vaccine series. These factors include sociodemographic factors, situational factors, personal factors, social factors, and health seeking and coping responses.
Subject Recruitment and Accrual
An RCT where 600 male parolees participating in an RDT program were randomized into one of three intervention conditions aimed at assessing program efficacy on reducing drug use and recidivism at 6 and 12 months, as well as vaccine completion in eligible subjects.
There were four inclusion criteria for recruitment purposes in assessing program efficacy on reducing drug use and recidivism: (1) history of drug use prior to their latest incarceration, (2) between ages of 18 and 60, (3) residing in the participating RDT program, and (4) designated as homeless as noted on the prison or jail discharge form.
Procedure The study was approved by the University of California, Los Angeles Institutional Review Board and registered with clinical Trials.gov. Building upon previous studies, we developed varying levels of peer-coached and nurse-led programs designed to improve HAV/HBV vaccine receptivity at 12-month follow-up among homeless offenders recently released to parole. See Appendix A for details in the “Interventions” section.
Intervention Fidelity
Several strategies for treatment fidelity included study design, interventionist’s training, and standardization of interventions. See the Interventions section in Appendix A.
HBA, Hepatitis A virus; HBV, hepatitis B virus; RCT, randomized clinical trial.
H I G H L I G H T Start an IPE Journal Club with students from other health professions programs on your campus. Select a research study to read, understand, and critically appraise together. It is always helpful to collaborate on deciding whether the findings are applicable to clinical practice.
Strategies for critiquing research studies Evaluation of a research article requires a critique. A critique is the process of critical appraisal that objectively and critically evaluates a research report’s content for scientific merit and application to practice. It requires some knowledge of the subject matter and knowledge of how to critically read and use critical appraisal criteria. You will find:
• Summarized examples of critical appraisal criteria for qualitative studies and an example of a qualitative critique in Chapter 7
• Summarized critical appraisal criteria and examples of a quantitative critique in Chapter 18
• An in-depth exploration of the criteria for evaluation required in quantitative research critiques in Chapters 8 through 18
• Criteria for qualitative research critiques presented in Chapters 5 through 7
• Principles for qualitative and quantitative research in Chapters 1 through 4
Critical appraisal criteria are the standards, appraisal guides, or questions used to assess an article. In analyzing a research article, you must evaluate each step of the research process and ask questions about whether each step meets the criteria. For instance, the critical appraisal criteria in Chapter 3 ask if “the literature review identifies gaps and inconsistencies in the literature about a subject, concept, or problem,” and if “all of the concepts and variables are included in the review.” These two questions relate to critiquing the research question and the literature review components of the research process. Box 1.1 lists several gaps identified in the literature by Nyamathi and colleagues (2015) and how the study intended to fill these gaps by conducting research for the stated objective and purpose (see Appendix A). Remember that when doing a critique, you are pointing out strengths as well as weaknesses. Standardized critical appraisal tools such as those from the Center for Evidence Based Medicine (CEBM) Critical Appraisal Tools (www.cebm.net/critical-appraisal) can be used to systematically appraise the strength and quality of evidence provided in research articles (see Chapter 20).
Critiquing can be thought of as looking at a completed jigsaw puzzle. Does it form a comprehensive picture, or is a piece out of place? What is the level of evidence provided by the study and the findings? What is the balance between the risks and benefits of the findings that contribute to clinical decisions? How can I apply the evidence to my patient, to my patient population, or in my setting? When reading several studies for synthesis, you must assess the interrelationship of the studies, as well as the overall strength and quality of evidence and applicability to practice. Reading for synthesis is essential in critiquing research. Appraising a study helps with the development of an evidence table (see Chapter 20).
Overcoming barriers: Useful critiquing strategies throughout the text, you will find features that will help refine the skills essential to understanding and using research in your practice. A Critical Thinking Decision Path related to each step of the research process in each chapter will sharpen your decision-making skills as you critique research articles. Look for Internet resources in chapters that will enhance your consumer skills. Critical Thinking Challenges, which appear at the end of each chapter, are designed to reinforce your critical reading skills in relation to the steps of the research process. Helpful Hints, designed to reinforce your understanding, appear at various points throughout the chapters. Evidence-Based Practice Tips, which will help you apply evidence-based practice strategies in your clinical practice, are provided in each chapter.
When you complete your first critique, congratulate yourself; mastering these skills is not easy. Best of all, you can look forward to discussing the points of your appraisal, because your critique will be based on objective data, not just personal opinion. As you continue to use and perfect critical analysis skills by critiquing studies, remember that these skills are an expected competency for delivering evidence- based and quality nursing care.
Evidence-based practice and research Along with gaining comfort while reading and critiquing studies, there is one final step: deciding how, when, and if to apply the studies to your practice so that your practice is evidence based. Evidence-based practice allows you to systematically use the best available evidence with the integration of individual clinical expertise, as well as the patient’s values and preferences, in making clinical decisions (Sackett et al., 2000). Evidence-based practice involves processes and steps, as does the research process. These steps are presented throughout the text. Chapter 19 provides an overview of evidence-based practice steps and strategies.
When using evidence-based practice strategies, the first step is to be able to read a study and understand how each section is linked to the steps of the research process. The following section introduces you to the research process as presented in published articles. Once you read a study, you must decide which level of evidence the study provides and how well the study was designed and executed. Fig. 1.1 illustrates a model for determining the levels of evidence associated with a study’s design, ranging from systematic reviews of randomized clinical trials (RCTs) (see Chapters 9 and 10) to expert opinions. The rating system, or evidence hierarchy model, presented here is just one of many. Many hierarchies for assessing the relative worth of both qualitative and quantitative designs are available. Early in the development of evidence-based practice, evidence hierarchies were thought to be very inflexible, with systematic reviews or meta-analyses at the top and qualitative research at the bottom. When assessing a clinical question that measures cause and effect, this may be true; however, nursing and health care research are involved in a broader base of problem solving, and thus assessing the worth of a study within a broader context of applying evidence into practice requires a broader view.
FIG 1.1 Levels of evidence: Evidence hierarchy for rating levels of evidence associated with a study’s design. Evidence is assessed at a level
according to its source.
The meaningfulness of an evidence rating system will become clearer as you read Chapters 8 through 11. ➤ Example: The Nyamathi et al. (2015) study is Level II because of its experimental, randomized control trial design, whereas the vanDijk et al. (2016) study is Level VI because it is a qualitative study. The level itself does not tell a study’s worth; rather it is another tool that helps you think about a study’s strengths and weaknesses and the nature of the evidence provided in the findings and conclusions. Chapters 7 and 18 will provide an understanding of how studies can be assessed for use in practice. You will use the evidence hierarchy presented in Fig. 1.1 throughout the book as you develop your research consumer skills, so become familiar with its content.
This rating system represents levels of evidence for judging the strength of a study’s design, which is just one level of assessment that influences the confidence one has in the conclusions the researcher has drawn. Assessing the strength of scientific evidence or potential research bias provides a vehicle to guide evaluation of research studies for their applicability in clinical decision making. In addition to identifying the level of evidence, one needs to grade the strength of a body of evidence, incorporating the domains of quality, quantity, and consistency (Agency for Healthcare Research and Quality, 2002).
• Quality: Extent to which a study’s design, implementation, and analysis minimize bias.
• Quantity: Number of studies that have evaluated the research question, including overall sample size across studies, as well as the strength of the findings from data analyses.
• Consistency: Degree to which studies with similar and different designs investigating the same research question report similar findings.
The evidence-based practice process steps are: ask, gather, assess and appraise, act, and evaluate (Fig. 1.2). These steps of asking clinical questions; identifying and gathering the evidence; critically appraising and synthesizing the evidence or literature; acting to change practice by coupling the best available evidence with your clinical expertise and patient preferences (e.g., values, setting, and resources); and evaluating if the use of the best available research evidence is applicable to your patient or organization will be discussed throughout the text.
FIG 1.2 Evidence-based practice steps.
To maintain an evidence-based practice, studies are evaluated using specific criteria. Completed studies are evaluated for strength, quality, and consistency of evidence. Before one can proceed with an evidence-based project, it is necessary to understand the steps of the research process found in research studies.
Research articles: Format and style Before you begin reading research articles, it is important to understand their organization and format. Many journals publish research, either as the sole type of article or in addition to clinical or theoretical articles. Many journals have some common features but also unique characteristics. All journals have guidelines for manuscript preparation and submission. A review of these guidelines, which are found on a journal’s website, will give you an idea of the format of articles that appear in specific journals.
Remember that even though each step of the research process is discussed at length in this text, you may find only a short paragraph or a sentence in an article that provides the details of the step. A publication is a shortened version of the researcher(s) completed work. You will also find that some researchers devote more space in an article to the results, whereas others present a longer discussion of the methods and procedures. Most authors give more emphasis to the method, results, and discussion of implications than to details of assumptions, hypotheses, or definitions of terms. Decisions about the amount of material presented for each step of the research process are bound by the following:
• A journal’s space limitations
• A journal’s author guidelines
• The type or nature of the study
• The researcher’s decision regarding which component of the study is the most important
The following discussion provides a brief overview of each step of the research process and how it might appear in an article. It is important to remember that a quantitative research article will differ from a qualitative research article. The components of qualitative research are discussed in Chapters 5 and 6, and are summarized in Chapter 7.
Abstract An abstract is a short, comprehensive synopsis or summary of a study at the beginning of an article. An abstract quickly focuses the reader on the main points of a study. A well-presented abstract is accurate, self-contained, concise, specific, nonevaluative, coherent, and readable. Abstracts vary in word length. The length and format of an abstract are dictated by the journal’s style. Both quantitative and qualitative research studies have abstracts that provide a succinct overview of the study. An example of an abstract can be found at the beginning of the study by Nyamathi et al. (2015) (see Appendix A). Their abstract follows an outline format that highlights the major steps of the study. It partially reads as follows:
Purpose/Objective: “The study focused on completion of the HAV and HBV vaccine series among homeless men on parole. The efficacy of the three levels of peer counseling (PC) and nurse delivered intervention was compared at 12 month follow up.”
In this example, the authors provide a view of the study variables. The remainder of the abstract provides a synopsis of the background of the study and the methods, results, and conclusions. The studies in Appendices A through D all have abstracts.
H E L P F U L H I N T An abstract is a concise short overview that provides a reference to the research purpose, research questions, and/or hypotheses, methodology, and results, as well as the implications for practice or future research.
Introduction Early in a research article, in a section that may or may not be labeled “Introduction,” the researcher presents a background picture of the area researched and its significance to practice (see Chapter 2).
Definition of the purpose The purpose of the study is defined either at the end of the researcher’s initial introduction or at the end of the “Literature Review” or “Conceptual Framework” section. The study’s purpose may or may not be labeled (see Chapters 2 and 3), or it may be referred to as the study’s aim or objective. The studies in Appendices A through D present specific purposes for each study in untitled sections that appear in the beginning of each article, as well as in the article’s abstract.
Literature review and theoretical framework Authors of studies present the literature review and theoretical framework in different ways. Many research articles merge the “Literature Review” and the “Theoretical Framework.” This section includes the main concepts investigated and may be called “Review of the Literature,” “Literature Review,” “Theoretical Framework,” “Related Literature,” “Background,” “Conceptual Framework,” or it may not be labeled at all (see Chapters 2 and 3). By reviewing Appendices A through D, you will find differences in the headings used. Nyamathi et al. (2015) (see Appendix A) use no labels and present the literature review but do have a section labeled theoretical framework, while the study in Appendix B has a literature review and a conceptual framework integrated in the beginning of the article. One style is not better than another; the studies in the appendices contain all the critical elements but present the elements differently.
H E L P F U L H I N T Not all research articles include headings for each step or component of the research process, but each step is presented at some point in the article.
Hypothesis/research question
A study’s research questions or hypotheses can also be presented in different ways (see Chapter 2). Research articles often do not have separate headings for reporting the “Hypotheses” or “Research Question.” They are often embedded in the “Introduction” or “Background” section or not labeled at all (e.g., as in the studies in the appendices). If a study uses hypotheses, the researcher may report whether the hypotheses were or were not supported toward the end of the article in the “Results” or “Findings” section. Quantitative research studies have hypotheses or research questions. Qualitative research studies do not have hypotheses, but have research questions and purposes. The studies in Appendices A, B, and D have hypotheses. The study in Appendix C does not, since it is a qualitative study; rather it has a purpose statement.