Methods and Critical Appraisal for Evidence-Based Practice
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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
About the authors
To the faculty
To the student
Acknowledgments I. Overview of Research and Evidence-Based Practice
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
II. Processes and Evidence Related to Qualitative Research
5. Introduction to qualitative research
6. Qualitative approaches to research
7. Appraising qualitative research
Critique of a qualitative research study
III. Processes and Evidence Related to Quantitative Research
8. Introduction to quantitative research
9. Experimental and quasi-experimental designs
10. Nonexperimental designs
11. Systematic reviews and clinical practice guidelines
13. Legal and ethical issues
14. Data collection methods
15. Reliability and validity
16. Data analysis: Descriptive and inferential statistics
17. Understanding research findings
18. Appraising quantitative research
Critique of a quantitative research study
Critique of a quantitative research study
IV. Application of Research: Evidence-Based Practice
19. Strategies and tools for developing an evidence-based practice
20. Developing an evidence-based practice
21. Quality improvement
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
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NURSING RESEARCH: METHODS AND CRITICAL APPRAISAL FOR EVIDENCE-BASED PRACTICE, NINTH EDITION ISBN: 978- 0-323-43131-6
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Notices Knowledge and best practice in this field are constantly changing.
As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.
With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions.
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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,  |
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
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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.
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, firstname.lastname@example.org
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, email@example.com
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.
Overview of Research and Evidence-Based Practice Research Vignette: Terri Armstrong
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
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.
Integrating research, evidence-based practice, and quality improvement processes Geri LoBiondo-Wood, Judith Haber
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.
levels of evidence