Methods and Critical Appraisal for Evidence-Based Practice
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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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.
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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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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.
PA R T I 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.
C H A P T E R 1
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.
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.
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.
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.
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.
Research design The type of research design can be found in the abstract, within the purpose statement, or in the introduction to the “Procedures” or “Methods” section, or not stated at all (see Chapters 6, 9, and 10). For example, the studies in Appendices A, B, and D identify the design in the abstract.
One of your first objectives is to determine whether the study is qualitative (see Chapters 5 and 6) or quantitative (see Chapters 8, 9, and 10). Although the rigor of the critical appraisal criteria addressed do not substantially change, some of the terminology of the questions differs for qualitative versus quantitative studies. Do not get discouraged if you cannot easily determine the design. One of the best strategies is to review the chapters that address designs. The following tips will help you determine whether the study you are reading employs a quantitative design:
• Hypotheses are stated or implied (see Chapter 2).
• The terms control and treatment group appear (see Chapter 9).
• The terms survey, correlational, case control, or cohort are used (see Chapter 10).
• The terms random or convenience are mentioned in relation to the sample (see Chapter 12).
• Variables are measured by instruments or scales (see Chapter 14).
• Reliability and validity of instruments are discussed (see Chapter 15).
• Statistical analyses are used (see Chapter 16).
In contrast, qualitative studies generally do not focus on “numbers.” Some qualitative studies may use standard quantitative terms (e.g., subjects) rather than qualitative terms (e.g., informants). Deciding on the type of qualitative design can be confusing; one of the best strategies is to review the qualitative chapters (see Chapters 5 through 7). Begin trying to link the study’s design with the level of evidence associated with that design as illustrated in Fig. 1.1. This will give you a context for evaluating the strength and consistency of the findings and applicability to practice. Chapters 8 through 11 will help you understand how to link the levels of evidence with quantitative designs. A study may not indicate the specific design used; however, all studies inform the reader of the methodology used, which can help you decide the type of design the authors used to guide the study.
Sampling The population from which the sample was drawn is discussed in the section “Methods” or “Methodology” under the subheadings of “Subjects” or “Sample” (see Chapter 12). Researchers should tell you both the population from which the sample was chosen and the number of subjects that participated in the study, as well as if they had subjects who dropped out of the study. The authors of the studies in the appendices discuss their samples in enough detail so that the reader is clear about who the subjects are and how they were selected.
Reliability and validity The discussion of the instruments used to study the variables is usually included in a “Methods” section under the subheading of “Instruments” or “Measures” (see Chapter 14). Usually each instrument (or scale) used in the study is discussed, as well as its reliability and validity (see Chapter 15). The studies in Appendices A, B, and D discuss each of the measures used in the “Methods” section under the subheading “Measures” or “Instruments.” The reliability and validity of each measure is also presented.
In some cases, the reliability and validity of commonly used, established instruments in an article are not presented, and you are referred to other references.
Procedures and collection methods The data collection procedures, or the individual steps taken to gather measurable data (usually with instruments or scales), are generally found in the “Procedures” section (see Chapter 14). In the studies in Appendices A through D, the researchers indicate how they conducted the study in detail under the subheading “Procedure” or “Instruments and Procedures.” Notice that the researchers in each study included in the Appendices provided information that the studies were approved by an institutional review board (see Chapter 13), thereby ensuring that each study met ethical standards.
Data analysis/results The data-analysis procedures (i.e., the statistical tests used and the results of descriptive and/or inferential tests applied in quantitative studies) are presented in the section labeled “Results” or “Findings” (see Chapters 16 and 17). Although qualitative studies do not use statistical tests, the procedures for analyzing the themes, concepts, and/or observational or print data are usually described in the “Method” or “Data Collection” section and reported in the “Results,” “Findings,” or “Data Analysis” section (see Appendix C and Chapters 5 and 6).
Discussion The last section of a research study is the “Discussion” (see Chapter 17). In this section the researchers tie together all of the study’s pieces
and give a picture of the study as a whole. The researchers return to the literature reviewed and discuss how their study is similar to, or different from, other studies. Researchers may report the results and discussion in one section but usually report their results in separate “Results” and “Discussion” sections (see Appendices A through D). One particular method is no better than another. Journal and space limitations determine how these sections will be handled. Any new or unexpected findings are usually described in the “Discussion” section.
Recommendations and implications In some cases, a researcher reports the implications and limitations based on the findings for practice and education, and recommends future studies in a separate section labeled “Conclusions”; in other cases, this appears in several sections, labeled with such titles as “Discussion,” “Limitations,” “Nursing Implications,” “Implications for Research and Practice,” and “Summary.” Again, one way is not better than the other—only different.
References All of the references cited are included at the end of the article. The main purpose of the reference list is to support the material presented by identifying the sources in a manner that allows for easy retrieval. Journals use various referencing styles.
Communicating results Communicating a study’s results can take the form of a published article, poster, or paper presentation. All are valid ways of providing data and have potential to effect high-quality patient care based on research findings. Evidence-based nursing care plans and QI practice protocols, guidelines, or standards are outcome measures that effectively indicate communicated research.
H E L P F U L H I N T If you have to write a paper on a specific concept or topic that requires you to critique and synthesize the findings from several studies, you might find it useful to create an evidence table of the data (see Chapter 20). Include the following information: author, date, study type, design, level of evidence, sample, data analysis, findings, and implications.
Systematic reviews: Meta-analyses, integrative reviews, and meta-syntheses
Systematic reviews Other article types that are important to understand for evidence-based practice are review articles. Review articles include systematic reviews, meta-analyses, integrative reviews (sometimes called narrative reviews), meta-syntheses, and meta-summaries. A systematic review is a summation and assessment of a group of research studies that test a similar research question. Systematic reviews are based on a clear question, a detailed plan which includes a search strategy, and appraisal of a group of studies related to the question. If statistical techniques are used to summarize and assess studies, the systematic review is labeled as a meta-analysis. A meta-analysis is a summary of a number of studies focused on one question or topic, and uses a specific statistical methodology to synthesize the findings in order to draw conclusions about the area of focus. An integrative review is a focused review and synthesis of research or theoretical literature in a particular focus area, and includes specific steps of literature integration and synthesis without statistical analysis; it can include both quantitative and qualitative articles (Cochrane Consumer Network, 2016; Uman, 2011; Whittemore, 2005). At times reviews use the terms systematic review and integrative review interchangeably. Both meta-synthesis and meta-summary are the synthesis of a number of qualitative research studies on a focused topic using specific qualitative methodology (Kastner et al., 2016; Sandelowski & Barrosos, 2007).
The components of review articles will be discussed in greater detail in Chapters 6, 11, and 20. These articles take a number of studies related to a clinical question and, using a specific set of criteria and methods, evaluate the studies as a whole. While they may vary somewhat in approach, these reviews all help to better inform and develop evidence-based practice. The meta-analysis in Appendix E is an example of a systematic review that is a meta-analysis.
Clinical guidelines Clinical guidelines are systematically developed statements or recommendations that serve as a guide for practitioners. Two types of clinical guidelines will be discussed throughout this text: consensus, or expert-developed guidelines, and evidence-based guidelines. Consensus guidelines, or expert-developed guidelines, are developed by an agreement of experts in the field. Evidence-based guidelines are those developed using published research findings. Guidelines are developed to assist in bridging practice and research and are developed by professional organizations, government agencies, institutions, or convened expert panels. Clinical guidelines provide clinicians with an algorithm for clinical management or decision making for specific diseases (e.g., breast cancer) or treatments (e.g., pain management). Not all clinical guidelines are well developed and, like research, must be assessed before implementation. Though they are systematically developed and make explicit recommendations for practice, clinical guidelines may be formatted differently. Guidelines for practice are becoming more important as third party and government payers are requiring practices to be based on evidence. Guidelines should present scope and purpose of the practice, detail who the development group included, demonstrate scientific rigor, be clear in its presentation, demonstrate clinical applicability, and demonstrate editorial independence (see Chapter 11).
Quality improvement As a health care provider, you are responsible for continuously improving the quality and safety of health care for your patients and their families through systematic redesign of health care systems in which you work. The Institute of Medicine (2001) defined quality health care as care that is safe, effective, patient-centered, timely, efficient, and equitable. Therefore, the goal of QI is to bring about measurable changes across these six domains by applying specific methodologies within a care setting. While several QI methods exist, the core steps for improvement commonly include the following:
• Conducting an assessment
• Setting specific goals for improvement
• Identifying ideas for changing current practice
• Deciding how improvements in care will be measured
• Rapidly testing practice changes
• Measuring improvements in care
• Adopting the practice change as a new standard of care
Chapter 21 focuses on building your competence to participate in and lead QI projects by providing an overview of the evolution of QI in health care, including the nurse’s role in meeting current regulatory requirements for patient care quality. Chapter 19 discusses QI models and tools, such as cause-and-effect diagrams and process mapping, as well as skills for effective teamwork and leadership that are essential for successful QI projects.
As you venture through this textbook, you will be challenged to think not only about reading and understanding research studies, but also about applying the findings to your practice. Nursing has a rich legacy of research that has grown in depth and breadth. Producers of research and clinicians must engage in a joint effort to translate findings into practice that will make a difference in the care of patients and families.
Key points • Research provides the basis for expanding the unique body of scientific evidence that forms the foundation of evidence-based nursing
practice. Research links education, theory, and practice.
• As consumers of research, nurses must have a basic understanding of the research process and critical appraisal skills to evaluate research evidence before applying it to clinical practice.
• Critical appraisal is the process of evaluating the strengths and weaknesses of a research article for scientific merit and application to practice, theory, or education; the need for more research on the topic or clinical problem is also addressed at this stage.
• Critical appraisal criteria are the measures, standards, evaluation guides, or questions used to judge the worth of a research study.
• Critical reading skills will enable you to evaluate the appropriateness of the content of a research article, apply standards or critical appraisal criteria to assess the study’s scientific merit for use in practice, or consider alternative ways of handling the same topic.
• A level of evidence model is a tool for evaluating the strength (quality, quantity, and consistency) of a research study and its findings.
• Each article should be evaluated for the study’s strength and consistency of evidence as a means of judging the applicability of findings to practice.
• Research articles have different formats and styles depending on journal manuscript requirements and whether they are quantitative or qualitative studies.
• Evidence-based practice and QI begin with the careful reading and understanding of each article contributing to the practice of nursing, clinical expertise, and an understanding of patient values.
• QI processes are aimed at improving clinical care outcomes for patients and better methods of system performance.
Critical thinking challenges • How might nurses discuss the differences between evidence-based practice and research with their colleagues in other professions?
• From your clinical practice, discuss several strategies nurses can undertake to promote evidence-based practice.
• What are some strategies you can use to develop a more comprehensive critique of an evidence-based practice article?
• A number of different components are usually identified in a research article. Discuss how these sections link with one another to ensure continuity.
• How can QI data be used to improve clinical practice?
Go to Evolve at http://evolve.elsevier.com/LoBiondo/ for review questions, critiquing exercises, and additional research articles for practice in reviewing and critiquing.
References 1. Agency for Healthcare Research and Quality. Systems to rate the strength of scientific evidence. File inventory, Evidence Report/Technology
Assessment No. 47. AHRQ Publication No. 02-E0162002. 2. Al-Mallah M.H, Farah I, Al-Madani W, et al. The impact of nurse-led clinics on the mortality and mortality of patients with cardiovascular
diseases A systematic review and meta-analysis. Journal of Cardiovascular Nursing 2015;31(1):89-95 Available at: doi:10.1097/JCN.00000000000000224.
3. American Nurses Association (ANA). Code of ethics for nurses for nurses with interpretive statements. Washington, DC: The Association;2015.
4. Cochrane Consumer Network, The Cochrane Library, 2016, retrieved online. Available at: www.cochranelibrary.com 5. Cronenwett L, Sherwood G, Barnsteiner J, et al. Quality and safety education for nurses. Nursing Outlook 2007;55(3):122-131. 6. Institute of Medicine [IOM]. The future of nursing Leading change, advancing health. Washington, DC: National Academic
Press;2011. 7. Institute of Medicine Committee on Quality of Health Care in America. Crossing the quality chasm A new health system for the 21st
century. Washington, DC: National Academy Press;2001. 8. Kastner M, Antony J, Soobiah C, et al. Conceptual recommendations for selecting the most appropriate knowledge synthesis method to answer
research questions related to complex evidence. Journal of Clinical Epidemiology 2016;73:43-49. 9. Nyamathi A, Salem B.E, Zhang S, et al. Nursing case management, peer coaching, and hepatitus A and B vaccine completion among homeless
men recently released on parole. Nursing Research 2015;64:177-189 Available at: doi:10.1097/NNR.0000000000000083. 10. Sackett D.L, Straus S, Richardson S, et al. Evidence-based medicine How to practice and teach EBM. 2nd ed. London: Churchill
Livingstone;2000. 11. Sandelowski M, Barroso J. Handbook of Qualitative Research. New York, NY: Springer Pub. Co.;2007. 12. Uman L.S. Systematic reviews and meta-analyses. Journal of the Canadian Academy of Child and Adolescent Psychiatry 2011;20(1):57-59. 13. vanDijk J.F.M, Vervoot S.C.J.M, vanWijck A.J.M, et al. Postoperative patients’ perspectives on rating pain A qualitative study.
International Journal of Nursing Studies 2016;53:260-269. 14. Whittemore R. Combining evidence in nursing research. Nursing Research 2005;54(1):56-62.
C H A P T E R 2
Research questions, hypotheses, and clinical questions Judith Haber
After reading this chapter, you should be able to do the following: • Describe how the research question and hypothesis relate to the other components of the research process. • Describe the process of identifying and refining a research question or hypothesis. • Discuss the appropriate use of research questions versus hypotheses in a research study. • Identify the criteria for determining the significance of a research question or hypothesis. • Discuss how the purpose, research question, and hypothesis suggest the level of evidence to be obtained from the findings of a research study. • Discuss the purpose of developing a clinical question. • Discuss the differences between a research question and a clinical question in relation to evidence-based practice. • Apply critiquing criteria to the evaluation of a research question and hypothesis in a research report.
clinical question complex hypothesis dependent variable directional hypothesis hypothesis independent variable nondirectional hypothesis population purpose research hypothesis research question statistical hypothesis testability theory variable
Go to Evolve at http://evolve.elsevier.com/LoBiondo/ for review questions, critiquing exercises, and additional research articles for practice in reviewing and critiquing.
At the beginning of this chapter, you will learn about research questions and hypotheses from the perspective of a researcher, which, in the second part of this chapter, will help you generate your own clinical questions that you will use to guide the development of evidence-based practice projects. From a clinician’s perspective, you must understand the research question and hypothesis as it aligns with the rest of a study. As a practicing nurse, developing clinical questions (see Chapters 19, 20, and 21) is the first step of the evidence-based practice process for quality improvement programs like those that decrease risk for development of pressure ulcers.
When nurses ask questions such as, “Why are things done this way?” “I wonder what would happen if . . . ?” “What characteristics are associated with . . . ?” or “What is the effect of ____ on patient outcomes?”, they are often well on their way to developing a research question or hypothesis. Research questions are usually generated by situations that emerge from practice, leading nurses to wonder about the effectiveness of one intervention versus another for a specific patient population.
The research question or hypothesis is a key preliminary step in the research process. The research question tests a measureable relationship to be examined in a research study. The hypothesis predicts the outcome of a study.
Hypotheses can be considered intelligent hunches, guesses, or predictions that provide researchers with direction for the research design and the collection, analysis, and interpretation of data. Hypotheses are a vehicle for testing the validity of the theoretical framework assumptions and provide a bridge between theory (a set of interrelated concepts, definitions, and propositions) and the real world (see Chapter 4).
For a clinician making an evidence-informed decision about a patient care issue, a clinical question, such as whether chlorhexidine or povidone-iodine is more effective in preventing central line catheter infections, would guide the nurse in searching and retrieving the best available evidence. This evidence, combined with clinical expertise and patient preferences, would provide an answer on which to base the most effective decision about patient care for this population.
Often the research questions or hypotheses appear at the beginning of a research article, but may be embedded in the purpose, aims, goals, or even the results section of the research report. This chapter provides you with a working knowledge of quantitative research questions and hypotheses. It also highlights the importance of clinical questions and how to develop them.
Developing and refining a research question: Study perspective A researcher spends a great deal of time refining a research idea into a testable research question. Research questions or topics are not pulled from thin air. In Table 2.1, you will see that research questions can indicate that practical experience, critical appraisal of the scientific literature, or interest in an untested theory forms the basis for the development of a research idea. The research question should reflect a refinement of the researcher’s initial thinking. The evaluator of a research study should be able to identify that the researcher has:
• Defined a specific question area
• Reviewed the relevant literature
• Examined the question’s potential significance to nursing
• Pragmatically examined the feasibility of studying the research question
TABLE 2.1 How Practical Experience, Scientific Literature, and Untested Theory Influence the Development of a Research Idea
Area Influence Example Clinical experience
Clinical practice provides a wealth of experience from which research problems can be derived. The nurse may observe a particular event or pattern and become curious about why it occurs, as well as its relationship to other factors in the patient’s environment.
Health professionals observe that despite improvements in symptom management for cancer patients receiving chemotherapy, side effects remain highly prevalent. Symptoms such as nausea/vomiting, diarrhea, constipation, and fatigue are common, and patients report that they negatively affect functional status and quality of life, including costly and distressing hospitalizations. A study by Traeger et al. (2015) tested a model integrated into outpatient care for patients with breast cancer, lung cancer, and colorectal cancer, designed to reduce symptom burden to be delivered by each patient’s oncology team nurse practitioner that included telephone follow-up, symptom assessment, advice, and triage according to actual clinical practice. The aim was to ensure optimal patient-NP management of side effects early in the course of care.
Critical appraisal of the scientific literature
Critical appraisal of studies in journals may indirectly suggest a clinical problem by stimulating the reader’s thinking. The nurse may observe the outcome data from a single study or a group of related studies that provide the basis for developing a pilot study, quality improvement project, or clinical practice guideline to determine the effectiveness of this intervention in their setting.
At a staff meeting with members of an interprofessional team at a cancer center, it was noted that the center did not have a standardized clinical practice guideline for mucositis, a painful chemotherapy side effect involving the oral cavity that has a negative impact on nutrition, oral hygiene, and comfort. The team wanted to identify the most effective approaches for treating adults and children experiencing mucositis. Their search for, and critical appraisal of, existing research studies led the team to develop an interprofessional mucositis guideline that was relevant to their patient population and clinical setting (NYU Langone Medical Center, 2016).
Gaps in the literature
A research idea may also be suggested by a critical appraisal of the literature that identifies gaps in the literature and suggests areas for future study. Research ideas also can be generated by research reports that suggest the value of replicating a particular study to extend or refine the existing scientific knowledge base.
Obesity is a widely recognized risk factor for many conditions treated in primary care settings including type 2 diabetes, cardiovascular disease, hypertension, and osteoarthritis. Although weight and achieving a healthy weight for children and adults is a Healthy People 2020 goal and a national priority, the prevalence of obesity remains high, and there is little research on targeted interventions for weight loss in primary care settings. Therefore, the purpose of a study by Thabault, Burke, and Ades (2015) was to evaluate an NP-led motivational interviewing IBT program implemented in an adult primary care practice with obese patients to determine feasibility and acceptance of the intervention.
Interest in untested theory
Verification of a theory and its concepts provides a relatively uncharted area from which research problems can be derived. Inasmuch as theories themselves are not tested, a researcher may consider investigating a concept or set of concepts related to a nursing theory or a theory from another discipline. The researcher would pose questions like, “If this theory is correct, what kind of behavior would I expect to observe in particular patients and under which conditions?” “If this theory is valid, what kind of supporting evidence will I find?”
Bandura’s (1997) health self-efficacy construct, an individual’s confidence in the ability to perform a behavior, overcome barriers to that behavior, and exert control over the behavior through self-regulation and goal setting, was used by Richards, Ogata, and Cheng (2016) to investigate whether health-related self-efficacy provides the untested theoretical foundation for behavior change related to increasing physical activity using a dog walking (Dogs PAW) intervention.
IBT, Intensive behavioral therapy.
Defining the research question Brainstorming with faculty or colleagues may provide valuable feedback that helps the researcher focus on a specific research question area. Example: ➤ Suppose a researcher told a colleague that her area of interest was health disparities about the effectiveness of peer coaching or case management in improving health outcomes with challenging patient populations such as those who are homeless. The colleague may have asked, “What is it about the topic that specifically interests you?” This conversation may have initiated a chain of thought that resulted in a decision to explore the effectiveness of a nursing case management and peer coaching intervention on hepatitis A and B (HAV and HBV) vaccine completion rates among homeless men recently released on parole (Nyamathi et al., 2015) (see Appendix A). Fig. 2.1 illustrates how a broad area of interest (health disparities, nursing case management, peer coaching) was narrowed to a specific research topic (effectiveness of nursing case management and peer coaching on HAV and HBV vaccine completion among homeless men recently released on parole).
FIG 2.1 Development of a research question.
E V I D E N C E – B A S E D P R A C T I C E T I P A well-developed research question guides a focused search for scientific evidence about assessing, diagnosing, treating, or providing patients with information about their prognosis related to a specific health problem.
Beginning the literature review The literature review should reveal a relevant collection of studies and systematic reviews that have been critically examined. Concluding sections in such articles (i.e., the recommendations and implications for practice) often identify remaining gaps in the literature, the need for replication, or the need for additional knowledge about a particular research focus (see Chapter 3). In the previous example, the researcher may have conducted a preliminary review of books and journals for theories and research studies on factors apparently critical to vaccine completion rates for preventable health problems like HAV and HBV, as well as risk factors contributing to the disproportionate impact of HAV and HBV on the homeless, such as risky sexual activity, drug use, substandard living conditions, and older age. These factors, called variables, should be potentially relevant, of interest, and measurable.
E V I D E N C E – B A S E D P R A C T I C E T I P The answers to questions generated by qualitative data reflect evidence that may provide the first insights about a phenomenon that has not been previously studied.
Other variables, called demographic variables, such as race, ethnicity, gender, age, education, and physical and mental health status, are also suggested as essential to consider. Example: ➤ Despite the availability of the HAV and HBV vaccines, there has been a low completion rate for the three-dose core of the accelerated vaccine series, particularly following release from prison. This information can then be used to further define the research question and continue the search of the literature to identify effective intervention strategies reported in other studies with similar high-risk populations (e.g., homeless) that could be applied to this population. Example: ➤ One study documented the effectiveness of a nurse case management program in improving vaccine completion rates in a group of homeless adults, but no studies were found about the effectiveness of peer coaching. At this point, the researcher could write the tentative research question: “What is the effectiveness of peer coaching and nursing case management on completion of an HAV and HBV vaccine series among homeless men on parole?” You can envision the interrelatedness of the initial definition of the question area, the literature review, and the refined research question.
H E L P F U L H I N T Reading the literature review or theoretical framework section of a research article helps you trace the development of the implied research question and/or hypothesis.
Examining significance When considering a research question, it is crucial that the researcher examine the question’s potential significance for nursing. This is sometimes referred to as the “so what” question, because the research question should have the potential to contribute to and extend the scientific body of nursing knowledge. Guidelines for selecting research questions should meet the following criteria:
• Patients, nurses, the medical community in general, and society will potentially benefit from the knowledge derived from the study.
• Results will be applicable for nursing practice, education, or administration.
• Findings will provide support or lack of support for untested theoretical concepts.
• Findings will extend or challenge existing knowledge by filling a gap or clarifying a conflict in the literature.
• Findings will potentially provide evidence that supports developing, retaining, or revising nursing practices or policies.
If the research question has not met any of these criteria, the researcher is wise to extensively revise the question or discard it. Example: ➤ In the previously cited research question, the significance of the question includes the following facts:
• HAV and HBV are vaccine preventable.
• Viral hepatitis disproportionately impacts the homeless.
• Despite its availability, vaccine completion rates are low among high-risk and incarcerated populations.
• Accelerated vaccine programs have shown success in RCT studies.
• The use of nurse case management programs in accelerated vaccine programs also provides evidence of effectiveness.
• Little is known about vaccine completion among ex-offender populations on parole using varying intensities of nurse case management and peer coaches.
• This study sought to fill a gap in the related literature by assessing whether seronegative parolees randomized to one of three intervention conditions were more likely to complete the vaccine series as well as to identify predictors of HAV/HBV vaccine completion.
H I G H L I G H T It is helpful to collaborate with colleagues from other professions to identify an important clinical question that provides data for a quality improvement on your unit.
The fully developed research question When a researcher finalizes a research question, the following characteristics should be evident:
• It clearly identifies the variables under consideration.
• It specifies the population being studied.
• It implies the possibility of empirical testing.
Because each element is crucial to developing a satisfactory research question, the criteria will be discussed in greater detail. These elements can often be found in the introduction of the published article; they are not always stated in an explicit manner.
Variables Researchers call the properties that they study “variables.” Such properties take on different values. Thus a variable, as the name suggests, is something that varies. Properties that differ from each other, such as age, weight, height, religion, and ethnicity, are examples of variables. Researchers attempt to understand how and why differences in one variable relate to differences in another variable. Example: ➤ A researcher may be concerned about the variable of pneumonia in postoperative patients on ventilators in critical care units. It is a variable because not all critically ill postoperative patients on ventilators have pneumonia. A researcher may also be interested in what other factors can be linked to ventilator-acquired pneumonia (VAP). There is clinical evidence to suggest that elevation of the head of the bed and frequent oral hygiene are associated with decreasing risk for VAP. You can see that these factors are also variables that need to be considered in relation to the development of VAP in postoperative patients.
When speaking of variables, the researcher is essentially asking, “Is X related to Y? What is the effect of X on Y? How are X1 and X2 related to Y?” The researcher is asking a question about the relationship between one or more independent variables and a dependent variable. (Note: In cases in which multiple independent or dependent variables are present, subscripts are used to indicate the number of variables under consideration.)
An independent variable, usually symbolized by X, is the variable that has the presumed effect on the dependent variable. In experimental research studies, the researcher manipulates the independent variable (see Chapter 9). In nonexperimental research, the independent variable is not manipulated and is assumed to have occurred naturally before or during the study (see Chapter 10).
The dependent variable, represented by Y, varies with a change in the independent variable. The dependent variable is not manipulated. It is observed and assumed to vary with changes in the independent variable. Predictions are made from the independent variable to the dependent variable. It is the dependent variable that the researcher is interested in understanding, explaining, or predicting. Example: ➤ It might be assumed that the perception of pain intensity (the dependent variable) will vary in relation to a person’s gender (the independent variable). In this case, we are trying to explain the perception of pain intensity in relation to gender (i.e., male or female). Although variability in the dependent variable is assumed to depend on changes in the independent variable, this does not imply that there is a causal relationship between X and Y, or that changes in variable X cause variable Y to change.
Table 2.2 presents a number of examples of research questions. Practice substituting other variables for the examples in Table 2.2. You will be surprised at the skill you develop in writing and critiquing research questions with greater ease.
Research Question Format
HBHC, Hospital-based home care.
Although one independent variable and one dependent variable are used in the examples, there is no restriction on the number of variables that can be included in a research question. Research questions that include more than one independent or dependent variable may be broken down into subquestions that are more concise.
Finally, it should be noted that variables are not inherently independent or dependent. A variable that is classified as independent in one study may be considered dependent in another study. Example: ➤ A nurse may review an article about depression that identifies depression in adolescents as predictive of risk for suicide. In this case, depression is the independent variable. When another article about the effectiveness of antidepressant medication alone or in combination with cognitive behavioral therapy (CBT) in decreasing depression in adolescents is considered, change in depression is the dependent variable. Whether a variable is independent or dependent is a function of the role it plays in a particular study.
Population The population is a well-defined set that has certain characteristics and is either clearly identified or implied in the research question. Example: ➤ In a retrospective cohort study studying the number of ED visits and hospitalizations in two different transition care programs, a research question may ask, “What is the differential effectiveness of nurse-led or physician-led intensive home visiting program providing transition care to patients with complex chronic conditions or receiving palliative care (Morrison, Palumbo, & Rambur, 2016)? Does a relationship exist between type of transition care model (nurse-led focused on chronic disease self-management or physician-led focused on palliative care and managing complex chronic conditions) and the number of ED visits and rehospitalizations 120 days pre- and posttransitional care interventions?” This question suggests that the population includes community-residing adults with complex chronic conditions or receiving palliative care who participated in either a nurse or physician-led transitional care program.
E V I D E N C E – B A S E D P R A C T I C E T I P Make sure that the population of interest and the setting have been clearly described so that if you were going to replicate the study, you would know exactly who the study population needed to be.
Testability The research question must imply that it is testable, measurable by either qualitative or quantitative methods. Example: ➤ The research question “Should postoperative patients control how much pain medication they receive?” is stated incorrectly for a variety of reasons. One reason is that it is not testable; it represents a value statement rather than a research question. A scientific research question must propose a measureable relationship between an independent and a dependent variable. Many interesting and important clinical questions are not valid research questions because they are not amenable to testing.
H E L P F U L H I N T Remember that research questions are used to guide all types of research studies but are most often used in exploratory, descriptive, qualitative, or hypothesis-generating studies.
The question “What are the relationships between vaccine completion rates among the ex-offender population and use of varying intensities of nurse case management and peer coaches?” is a testable research question. It illustrates the relationship between the variables, identifies the independent and dependent variables, and implies the testability of the research question. Table 2.3 illustrates how this research question is congruent with the three research question criteria.
TABLE 2.3 Components of the Research Question and Related Criteria
This research question was originally derived from a general area of interest: health-seeking behavior and coping (HAV and HBV vaccine completion rates) in a high-risk population (ex-offenders on parole, homeless), factors related to vaccine completion (age, education, race/ethnicity, marital, and parental status), and potential strategies (nurse case management and peer coaching) to improve protective
behaviors and health outcomes. The question crystallized further after a preliminary literature review (Nyamathi et al., 2015).
H E L P F U L H I N T
• Remember that research questions are often not explicitly stated. The reader has to infer the research question from the title of the report, the abstract, the introduction, or the purpose.
• Using your focused question, search the literature for the best available answer to your clinical question.
Study purpose, aims, or objectives The purpose of the study encompasses the aims or objectives the investigator hopes to achieve with the research. These three terms are synonymous. The researcher selects verbs to use in the purpose statement that suggest the planned approach to be used when studying the research question as well as the level of evidence to be obtained through the study findings. Verbs such as discover, explore, or describe suggest an investigation of an infrequently researched topic that might appropriately be guided by research questions rather than hypotheses. In contrast, verb statements indicating that the purpose is to test the effectiveness of an intervention or compare two alternative nursing strategies suggest a hypothesis-testing study for which there is an established knowledge base of the topic.
Remember that when the purpose of a study is to test the effectiveness of an intervention or compare the effectiveness of two or more interventions, the level of evidence is likely to have more strength and rigor than a study whose purpose is to explore or describe phenomena. Box 2.1 provides examples of purpose, aims, and objectives. BOX 2.1
E x a m p l e s o f P u r p o s e S t a t e m e n t s
• The purpose of this study was to explore the relationship between future expectations, attitude toward use of violence to solve problems, and self-reported physical and relational bullying perpetration in a sample of seventh grade students (Stoddard, Varela, & Zimmerman, 2015). The aim of this study was to determine knowledge, awareness, and practices of Turkish hospital nurses in relation to cervical cancer, HPV, and HPV (Koc & Cinarli, 2015).
• The purposes of this longitudinal study with a sample composed of Hispanic, Black non-Hispanic, and White non-Hispanic bereaved parents were to test the relationships between spiritual/religious coping strategies and grief, mental health, and personal growth for mothers and fathers at 1 and 3 months after the infant/child’s death in the NICU/PICU (Hawthorne et al., 2016). The goals of the current study were to examine psychological functioning and coping in parents and siblings of adolescent cancer survivors (Turner-Sack et al., 2016).
E V I D E N C E – B A S E D P R A C T I C E T I P The purpose, aims, or objectives often provide the most information about the intent of the research question and hypotheses, and suggest the level of evidence to be obtained from the findings of the study.
Developing the research hypothesis Like the research question, hypotheses are often not stated explicitly in a research article. You will often find that hypotheses are embedded in the data analysis, results, or discussion section of the research report. Similarly, the population may not be explicitly stated, but will have been identified in the background, significance, and literature review. It is then up to you to figure out the hypotheses and population being tested. Example: ➤ In a study by Turner-Sack and colleagues (2016) (see Appendix B), the hypotheses are embedded in the “Data Analysis” and “Results” sections of the article. You must interpret that the statement, “Independent sample t-tests were conducted to compare the survivors, siblings, and parents on measures of psychological distress, life satisfaction, posttraumatic growth (PTG), and that of their matched parents” to understand that it represents hypotheses used to compare psychological functioning, PTG, coping, and cancer-related characteristics of adolescent cancer survivors’ parents and siblings.
Hypotheses flow from the study’s purpose, literature review, and theoretical framework. Fig. 2.2 illustrates this flow. A hypothesis is a declarative statement about the relationship between two or more variables. A hypothesis predicts an expected outcome of a study. Hypotheses are developed before the study is conducted because they provide direction for the collection, analysis, and interpretation of data.
FIG 2.2 Interrelationships of purpose, literature review, theoretical framework, and hypothesis.
H E L P F U L H I N T When hypotheses are not explicitly stated by the author at the end of the introduction section or just before the methods section, they will be embedded or implied in the data analysis, results, or discussion section of a research article.
Relationship statement The first characteristic of a hypothesis is that it is a declarative statement that identifies the predicted relationship between two or more variables: the independent variable (X) and a dependent variable (Y). The direction of the predicted relationship is also specified in this statement. Phrases such as greater than, less than, positively, negatively, or difference in suggest the directionality that is proposed in the hypothesis. The following is an example of a directional hypothesis: “Nurse staff members’ perceptions of transformational leadership among their nurse leaders (independent variable) is that it is negatively associated with nurse staff burnout (dependent variable)” (Lewis & Cunningham, 2016). The dependent and independent variables are explicitly identified, and the relational aspect of the prediction in the hypothesis is contained in the phrase “negatively associated with.”
The nature of the relationship, either causal or associative, is also implied by the hypothesis. A causal relationship is one in which the researcher can predict that the independent variable (X) causes a change in the dependent variable (Y). In research, it is rare that one is in a firm enough position to take a definitive stand about a cause-and-effect relationship. Example: ➤ A researcher might hypothesize selected determinants of the decision-making process, specifically expectation, socio-demographic factors, and decisional conflict would predict postdecision satisfaction and regret about their choice of treatment for breast cancer in Chinese-American women (Lee & Knobf, 2015). It would be difficult for a researcher to predict a cause-and-effect relationship, however, because of the multiple intervening variables (e.g., values, culture, role, support from others, personal resources, language literacy) that might also influence the subject’s decision making about treatment for their breast cancer diagnosis.
Variables are more commonly related in noncausal ways; that is, the variables are systematically related but in an associative way. This means that the variables change in relation to each other. Example: ➤ There is strong evidence that asbestos exposure is related to lung cancer. It is tempting to state that there is a causal relationship between asbestos exposure and lung cancer. Do not overlook the fact, however, that not all of those who have been exposed to asbestos will have lung cancer, and not all of those who have lung cancer have had asbestos exposure. Consequently, it would be scientifically unsound to take a position advocating the presence of a causal relationship between these two variables. Rather, one can say only that there is an associative relationship between the variables of asbestos exposure and lung cancer, a relationship in which there is a strong systematic association between the two phenomena.
Testability The second characteristic of a hypothesis is its testability. This means that the variables of the study must lend themselves to observation, measurement, and analysis. The hypothesis is either supported or not supported after the data have been collected and analyzed. The predicted outcome proposed by the hypothesis will or will not be congruent with the actual outcome when the hypothesis is tested.
H E L P F U L H I N T When a hypothesis is complex (i.e., it contains more than one independent or dependent variable), it is difficult for the findings to indicate unequivocally that the hypothesis is supported or not supported. In such cases, the reader must infer which relationships are significant in the predicted direction from the findings or discussion section.
Theory base The third characteristic is that the hypothesis is consistent with an existing body of theory and research findings. Whether a hypothesis is arrived at on the basis of a review of the literature or a clinical observation, it must be based on a sound scientific rationale. You should be able to identify the flow of ideas from the research idea to the literature review, to the theoretical framework, and through the research question(s) or hypotheses. Example: ➤ Nyamathi and colleagues (2015) (see Appendix A) investigated the effectiveness of a nursing case management intervention in comparison to a peer coaching intervention based on the comprehensive health-seeking and coping paradigm developed by Nyamathi in 1989, adapted from a coping model by Lazarus and Folkman (1984), and the health-seeking and coping paradigm by Schlotfeldt (1981), which is a useful theoretical framework for case management, peer coaching interventions, and vaccine completion outcomes.
Wording the hypothesis As you read the scientific literature and become more familiar with it, you will observe that there are a variety of ways to word a hypothesis that are described in Tables 2.4 and 2.5. Information about hypotheses may be further clarified in the instruments, sample, or methods sections of a research report (see Chapters 12 and 15).
TABLE 2.4 Examples of How Hypotheses are Worded
BP, Blood pressure; CRNA, Certified Nurse Anesthetists; DV, dependent variable; IV, independent variable; TM, telemonitoring; UC, usual care.
TABLE 2.5 Examples of Statistical Hypotheses
ANPs, Adult nurse practitioners; FNPs, family nurse practitioners; DV, dependent variable; IV, independent variable.
Statistical versus research hypotheses You may observe that a hypothesis is further categorized as either a research or a statistical hypothesis. A research hypothesis, also known as a scientific hypothesis, consists of a statement about the expected relationship of the variables. A research hypothesis indicates what the outcome of the study is expected to be. A research hypothesis is also either directional or nondirectional. If the researcher obtains statistically significant findings for a research hypothesis, the hypothesis is supported. The examples in Table 2.4 represent research hypotheses.
A statistical hypothesis, also known as a null hypothesis, states that there is no relationship between the independent and dependent variables. The examples in Table 2.5 illustrate statistical hypotheses. If, in the data analysis, a statistically significant relationship emerges between the variables at a specified level of significance, the null hypothesis is rejected. Rejection of the statistical hypothesis is equivalent to acceptance of the research hypothesis.
Directional versus nondirectional hypotheses Hypotheses can be formulated directionally or nondirectionally. A directional hypothesis specifies the expected direction of the relationship between the independent and dependent variables. An example of a directional hypothesis is provided in a study by Parry and colleagues (2015) that investigated a novel noninvasive device to assess sympathetic nervous system functioning in patients with heart failure. The researchers hypothesized that participants with heart failure reduced ejection fraction (HFrEF), who have internal cardiac defibrillators or CRT pacemakers, will have a decrease in pre-ejection period (reflective of increased sympathetic nervous system activity) and decrease in left ventricular ejection time (reflective of an increased heart rate) with a postural change from sitting to standing.
In contrast, a nondirectional hypothesis indicates the existence of a relationship between the variables, but does not specify the anticipated direction of the relationship. Example: ➤ Rattanawiboon and colleagues (2016) evaluated the effectiveness of fluoride mouthwash delivery methods, swish, spray, or swab application, in raising salivary fluoride in comparison to conventional fluoride mouthwash, but did not predict which form of fluoride delivery would be most effective. Nurses who are learning to critically appraise research studies should be aware that both the directional and the nondirectional forms of hypothesis statements are acceptable.
Relationship between the hypothesis and the research design Regardless of whether the researcher uses a statistical or a research hypothesis, there is a suggested relationship between the hypothesis, the design of the study, and the level of evidence provided by the results of the study. The type of design, experimental or nonexperimental (see Chapters 9 and 10), will influence the wording of the hypothesis. Example: ➤ When an experimental design is used, you would expect to see hypotheses that reflect relationship statements, such as the following:
• X1 is more effective than X2 on Y.
• The effect of X1 on Y is greater than that of X2 on Y.
• The incidence of Y will not differ in subjects receiving X1 and X2 treatments.
• The incidence of Y will be greater in subjects after X1 than after X2.
E V I D E N C E – B A S E D P R A C T I C E T I P Think about the relationship between the wording of the hypothesis, the type of research design suggested, and the level of evidence provided by the findings of a study using each kind of hypothesis. You may want to consider which type of hypothesis potentially will yield the strongest results applicable to practice.
Hypotheses reflecting experimental designs also test the effect of the experimental treatment (i.e., independent variable X) on the outcome (i.e., dependent variable Y). This suggests that the strength of the evidence provided by the results is Level II (experimental design) or Level III (quasi-experimental design).
In contrast, hypotheses related to nonexperimental designs reflect associative relationship statements, such as the following:
• X will be negatively related to Y.
• There will be a positive relationship between X and Y.
This suggests that the strength of the evidence provided by the results of a study that examined hypotheses with associative relationship statements would be at Level IV (nonexperimental design).
Table 2.6 provides an example of this concept. The Critical Thinking Decision Path will help you determine the type of hypothesis or research question presented in a study.
TABLE 2.6 Elements of a Clinical Question
CAUTIs, Catheter acquired urinary tract infections.
C R I T I C A L T H I N K I N G D E C I S I O N PAT H Determining the Use of a Hypothesis or Research Question
Developing and refining a clinical question: A consumer’s perspective Practicing nurses, as well as students, are challenged to keep their practice up to date by searching for, retrieving, and critiquing research articles that apply to practice issues that are encountered in their clinical setting (see Chapter 20). Practitioners strive to use the current best evidence from research when making clinical and health care decisions. As research consumers, you are not conducting research studies; however, your search for information from clinical practice is converted into focused, structured clinical questions that are the foundation of evidence-based practice and quality improvement projects. Clinical questions often arise from clinical situations for which there are no ready
answers. You have probably had the experience of asking, “What is the most effective treatment for . . . ?” or “Why do we still do it this way?”
Using similar criteria related to framing a research question, focused clinical questions form a basis for searching the literature to identify supporting evidence from research. Clinical questions have four components:
These components, known as PICO, provide an effective format for helping nurses develop searchable clinical questions. Box 2.2 presents each component of the clinical question. BOX 2.2
C o m p o n e n t s o f a C l i n i c a l Q u e s t i o n U s i n g t h e P I C O F o r m a t Population: The individual patient or group of patients with a particular condition or health care problem (e.g., adolescents age 13–18 with type 1 insulin-dependent diabetes)
Intervention: The particular aspect of health care that is of interest to the nurse or the health team (e.g., a therapeutic [inhaler or nebulizer for treatment of asthma], a preventive [pneumonia vaccine], a diagnostic [measurement of blood pressure], or an organizational [implementation of a bar coding system to reduce medication errors] intervention)
Comparison intervention: Standard care or no intervention (e.g., antibiotic in comparison to ibuprofen for children with otitis media); a comparison of two treatment settings (e.g., rehabilitation center vs. home care)
Outcome: More effective outcome (e.g., improved glycemic control, decreased hospitalizations, decreased medication errors)
The significance of the clinical question becomes obvious as research evidence from the literature is critically appraised. Research evidence is used together with clinical expertise and the patient’s perspective to confirm, develop, or revise nursing standards, protocols, and policies that are used to plan and implement patient care (Cullum, 2000; Sackett et al., 2000; Thompson et al., 2004). Issues or questions can arise from multiple clinical and managerial situations. Using the example of catheter acquired urinary tract infections (CAUTIs), a team of staff nurses working on a medical unit in an acute care setting were reviewing their unit’s quarterly quality improvement data and observed that the number of CAUTIs had increased by 25% over the past 3 months. The nursing staff reviewed the unit’s standard of care and noted that although nurses were able to discontinue an indwelling catheter, according to a set of criteria and without a physician order, catheters were remaining in place for what they thought was too long and potentially contributing to an increase in the prevalence of CAUTIs. To focus the nursing staff’s search of the literature, they developed the following question: Does the use of daily nurse-led catheter rounds in hospitalized older adults with indwelling urinary catheters lead to a decrease in CAUTIs? Sometimes it is helpful for nurses who develop clinical questions from a quality improvement perspective to consider three elements as they frame their focused question: (1) the situation, (2) the intervention, and (3) the outcome.
• The situation is the patient or problem being addressed. This can be a single patient or a group of patients with a particular health problem (e.g., hospitalized adults with indwelling urinary catheters).
• The intervention is the dimension of health care interest, and often asks whether a particular intervention is a useful treatment (e.g., daily nurse-led catheter rounds).
• The outcome addresses the effect of the treatment (e.g., intervention) for this patient or patient population in terms of quality and cost (e.g., decreased CAUTIs). It essentially answers whether the intervention makes a difference for the patient population.
The individual parts of the question are vital pieces of information to remember when it comes to searching for evidence in the literature. One of the easiest ways to do this is to use a table, as illustrated in Table 2.6. Examples of clinical questions are highlighted in Box 2.3. Chapter 3 provides examples of how to effectively search the literature to find answers to questions posed by researchers and research consumers. BOX 2.3
E x a m p l e s o f C l i n i c a l Q u e s t i o n s
• Does using a Discharge Bundle combined with Teachback Methodology reduce pediatric readmissions? (Shermont et al., 2016)
• What is the most effective IV insulin practice guideline for cardiac surgery patients? (Westbrook et al., 2016)
• Does using a structured content and electronic nursing handover reduce patient clinical management errors? (Johnson et al., 2016)
• What is the impact of nursing teamwork on nurse-sensitive quality indicators? (Rahn, 2016)
• Do PCMH access and care coordination measures reflect the contributions of all team members? (Annis et al., 2016)
• Is a patient-family-staff partnership video the most effective approach for preventing falls in hospitalized patients? (Silkworth et al., 2016)
• What is the impact of prompt nutrition care on patient outcomes and health care costs? (Meehan et al., 2016)
PCMH, Patient-centered medical home.
E V I D E N C E – B A S E D P R A C T I C E T I P
You should be formulating clinical questions that arise from your clinical practice. Once you have developed a focused clinical question using the PICO format, you will search the literature for the best available evidence to answer your clinical question.
Appraisal for evidence-based practice the research question and hypothesis When you begin to critically appraise a research study, consider the care the researcher takes when developing the research question or hypothesis; it is often representative of the overall conceptualization and design of the study. In a quantitative research study, the remainder of a study revolves around answering the research question or testing the hypothesis. In a qualitative research study, the objective is to answer the research question. Because this text focuses on you as a research consumer, the following sections will primarily pertain to the evaluation of research questions and hypotheses in published research reports.
Critiquing the research question and hypothesis The following Critical Appraisal Criteria box provides several criteria for evaluating the initial phase of the research process—the research question or hypothesis. Because the research question or hypothesis guides the study, it is usually introduced at the beginning of the research report to indicate the focus and direction of the study. You can then evaluate whether the rest of the study logically flows from its foundation—the research question or hypothesis. The author will often begin by identifying the background and significance of the issue that led to crystallizing development of the research question or hypothesis. The clinical and scientific background and/or significance will be summarized, and the purpose, aim, or objective of the study is then identified.
Often the research question or hypothesis will be proposed before or after the literature review. Sometimes you will find that the research question or hypothesis is not specifically stated. In some cases, it is only hinted at or is embedded in the purpose statement, and you are challenged to identify the research question or hypothesis. In other cases, the research question is embedded in the findings toward the end of the article. To some extent, this depends on the style of the journal.
Although a hypothesis can legitimately be nondirectional, it is preferable, and more common, for the researcher to indicate the direction of the relationship between the variables in the hypothesis. Quantifiable words such as “greater than,” “less than,” “decrease,” “increase,” and “positively,” “negatively,” or “related” convey the idea of objectivity and testability. You should immediately be suspicious of hypotheses or research questions that are not stated objectively. You will find that when there is a lack of data available for the literature review (i.e., the researcher has chosen to study a relatively undefined area of interest), a nondirectional hypothesis or research question may be appropriate.
You should recognize that how the proposed relationship of the hypothesis or research question is phrased suggests the type of research design that will be appropriate for the study, as well as the level of evidence to be derived from the findings. Example: ➤ If a hypothesis proposes that treatment X1 will have a greater effect on Y than treatment X2, an experimental (Level II evidence) or quasi-experimental design (Level III evidence) is suggested (see Chapter 9). If a research question asks if there will be a positive relationship between variables X and Y, a nonexperimental design (Level IV evidence) is suggested (see Chapter10).
Hypotheses and research questions are never proven beyond the shadow of a doubt. Researchers who claim that their data have “proven” the validity of their hypothesis or research question should be regarded with grave reservation. You should realize that, at best, findings that support a hypothesis or research question are considered tentative. If repeated replication of a study yields the same results, more confidence can be placed in the conclusions advanced by the researchers.
When critically appraising clinical questions, think about the fact that the clinical question should be focused and specify the patient population or clinical problem being addressed, the intervention, and the outcome for a particular patient population. There should be evidence that the clinical question guided the literature search and that appropriate types of research studies are retrieved in terms of the study design and level of evidence needed to answer the clinical question.
C R I T I C A L A P P R A I S A L C R I T E R I A Developing Research Questions and Hypotheses
The research question
1. Does the research question express a relationship between two or more variables, or at least between an independent and a dependent variable, implying empirical testability?
2. How does the research question specify the nature of the population being studied?
3. How has the research question been supported with adequate experiential and scientific background material?
4. How has the research question been placed within the context of an appropriate theoretical framework?
5. How has the significance of the research question been identified?
6. Have pragmatic issues, such as feasibility, been addressed?
7. How have the purpose, aims, or goals of the study been identified?
1. Is the hypothesis concisely stated in a declarative form?
2. Are the independent and dependent variables identified in the statement of the hypothesis?
3. Is each hypothesis specific to one relationship so that each hypothesis can be either supported or not supported?
4. Is the hypothesis stated in such a way that it is testable?
5. Is the hypothesis stated objectively, without value-laden words?
6. Is the direction of the relationship in each hypothesis clearly stated?
7. How is each hypothesis consistent with the literature review?
8. How is the theoretical rationale for the hypothesis made explicit?
9. Given the level of evidence suggested by the research question, hypothesis, and design, what is the potential applicability to practice?
The clinical question
1. Does the clinical question specify the patient population, intervention, comparison intervention, and outcome?
2. Does the clinical question address an outcome applicable to practice?
Key points • Developing the research question and stating the hypothesis are key preliminary steps in the research process.
• The research question is refined through a process that proceeds from the identification of a general idea of interest to the definition of a more specific and circumscribed topic.
• A preliminary literature review reveals related factors that appear critical to the research topic of interest and helps further define the research question.
• The significance of the research question must be identified in terms of its potential contribution to patients, nurses, the medical community in general, and society. Applicability of the question for nursing practice, as well as its theoretical relevance, must be established. The findings should also have the potential for formulating or altering nursing practices or policies.
• The final research question is a statement about the relationship of two or more variables. It clearly identifies the relationship between the independent and dependent variables, specifies the nature of the population being studied, and implies the possibility of empirical testing.
• Research questions that are nondirectional may be used in exploratory, descriptive, or qualitative research studies.
• Research questions can be directional, depending on the type of study design being used.
• Focused clinical questions arise from clinical practice and guide the literature search for the best available evidence to answer the clinical question.
• A hypothesis is a declarative statement about the relationship between two or more variables that predicts an expected outcome. Characteristics of a hypothesis include a relationship statement, implications regarding testability, and consistency with a defined theory base.
• Hypotheses can be formulated in a directional or a nondirectional manner and be further categorized as either research or statistical hypotheses.
• The purpose, research question, or hypothesis provides information about the intent of the research question and hypothesis and suggests the level of evidence to be obtained from the study findings.
• The interrelatedness of the research question or hypothesis and the literature review and the theoretical framework should be apparent.
• The appropriateness of the research design suggested by the research question or hypothesis is also evaluated.
Critical thinking challenges • Discuss how the wording of a research question or hypothesis suggests the type of research design and level of evidence that will be
• Using the study by Hawthorne, Youngblut, and Brooten (2016) (see Appendix B), describe how the background, significance, and purpose of the study are linked to the research questions.
• The prevalence of catheter acquired urinary infections (CAUTIs) has increased on your hospital unit by 10% in the last two quarters. As a member of the Quality Improvement (QI) Committee on your unit, collaborate with your committee colleagues from other professions to develop an interprofessional action plan. Deliberate to develop a clinical question to guide the QI project.
• A nurse is in charge of discharge planning for frail older adults with congestive heart failure. The goal of the program is to promote self- care and prevent rehospitalizations. Using the PICO approach, the nurse wants to develop a clinical question for an evidence-based practice project to evaluate the effectiveness of discharge planning for this patient population. How can the nurse accomplish that objective?