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Nursing Research
NINETH EDITION
2
Table of Contents
Cover image
Title page
Copyright
Contributors
Reviewers
To the faculty
To the student
Acknowledgments
I. Overview of Research and Evidence-Based Practice
Introduction
References
Introduction
3
References
References
References
Introduction
References
12. Sampling
References
4
References
References
References
References
Introduction
References
Example of a randomized clinical trial (Nyamathi et al., 2015) Nursing case management peer
coaching and hepatitis A and B vaccine completion among homeless men recently released on
parole
Example of a longitudinal/Cohort study (Hawthorne et al., 2016) Parent spirituality grief and
mental health at 1 and 3 months after their infant schild s death in an intensive care unit
Example of a qualitative study (van dijk et al., 2015) Postoperative patients perspectives on rating
pain: A qualitative study
Example of a correlational study (Turner et al., 2016) Psychological functioning post traumatic
growth and coping in parents and siblings of adolescent cancer survivors
Example of a systematic Review/Meta analysis (Al mallah et al., 2015) The impact of nurse led
clinics on the mortality and morbidity of patients with cardiovascular diseases
Glossary
Index
5
Special features
6
Copyright
No part of this publication may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying, recording, or any information storage and
retrieval system, without permission in writing from the publisher. Details on how to seek
permission, further information about the Publisher’s permissions policies, and our arrangements
with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency
can be found at our website: www.elsevier.com/permissions.
This book and the individual contributions contained in it are protected under copyright by the
Publisher (other than as may be noted herein).
Notices
Knowledge and best practice in this field are constantly changing. As new research and experience
broaden our understanding, changes in research methods, professional practices, or medical
treatment may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in
evaluating and using any information, methods, compounds, or experiments described herein. In
using such information or methods they should be mindful of their own safety and the safety of
others, including parties for whom they have a professional responsibility.
With respect to any drug or pharmaceutical products identified, readers are advised to check the
most current information provided (i) on procedures featured or (ii) by the manufacturer of each
product to be administered, to verify the recommended dose or formula, the method and duration
of administration, and contraindications. It is the responsibility of practitioners, relying on their
own experience and knowledge of their patients, to make diagnoses, to determine dosages and the
best treatment for each individual patient, and to take all appropriate safety precautions.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors
assume any liability for any injury and/or damage to persons or property as a matter of products
liability, negligence or otherwise, or from any use or operation of any methods, products,
instructions, or ideas contained in the material herein.
Previous editions copyrighted 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986.
7
practice / [edited by] Geri LoBiondo-Wood, Judith Haber.
Other titles: Nursing research (LoBiondo-Wood)
Description: 9th edition. | St. Louis, Missouri : Elsevier, [2018] | Includes
bibliographical references and index.
Identifiers: LCCN 2017008727 | ISBN 9780323431316 (pbk. : alk. paper)
Subjects: | MESH: Nursing Research—methods | Research Design |
Evidence-Based Nursing—methods
Classification: LCC RT81.5 | NLM WY 20.5 | DDC 610.73072—dc23 LC record available
at https://lccn.loc.gov/2017008727
Printed in China
8
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
9
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.
10
Contributors
Terri Armstrong, PhD, ANP-BC, FAANP, Senior Investigator, Neuro-oncology Branch, Center
for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
Julie Barroso, PhD, ANP, RN, FAAN, Professor and Department Chair, Medical University of
South Carolina, Charleston, South Carolina
Carol Bova, PhD, RN, ANP, Professor of Nursing and Medicine, Graduate School of Nursing,
University of Massachusetts, Worcester, Massachusetts
Dona Rinaldi Carpenter, EdD, RN, Professor and Chair, University of Scranton, Department of
Nursing, Scranton, Pennsylvania
Maja Djukic, PhD, RN, Assistant Professor, Rory Meyers College of Nursing, New York
University, New York, New York
Mei R. Fu, PhD, RN, FAAN, Associate Professor, Rory Meyers College of Nursing, New York
University, New York, New York
Mattia J. Gilmartin, PhD, RN, Senior Research Scientist , Executive Director, NICHE Program,
Rory Meyers College of Nursing, New York University, New York, New York
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
11
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
12
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
13
To the faculty
Geri LoBiondo-Wood, Geri.L.Wood@uth.tmc.edu, Judith Haber, jh33@nyu.edu
The foundation of the ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-
Based Practice continues to be the belief that nursing research is integral to all levels of nursing
education and practice. Over the past three decades since the first edition of this textbook, we have
seen the depth and breadth of nursing research grow, with more nurses conducting research and
using research evidence to shape clinical practice, education, administration, and health policy.
The National Academy of Medicine has challenged all health professionals to provide team-based
care based on the best available scientific evidence. This is an exciting challenge. Nurses, as
clinicians and interprofessional team members, are using the best available evidence, combined
with their clinical judgment and patient preferences, to influence the nature and direction of health
care delivery and document outcomes related to the quality and cost-effectiveness of patient care.
As nurses continue to develop a unique body of nursing knowledge through research, decisions
about clinical nursing practice will be increasingly evidence based.
As editors, we believe that all nurses need not only to understand the research process but also to
know how to critically read, evaluate, and apply research findings in practice. We realize that
understanding research, as a component of evidence-based practice and quality improvement
practices, is a challenge for every student, but we believe that the challenge can be accomplished in
a stimulating, lively, and learner-friendly manner.
Consistent with this perspective is an ongoing commitment to advancing implementation of
evidence-based practice. Understanding and applying research must be an integral dimension of
baccalaureate education, evident not only in the undergraduate nursing research course but also
threaded throughout the curriculum. The research role of baccalaureate graduates calls for
evidence-based practice and quality improvement competencies; central to this are critical appraisal
skills—that is, nurses should be competent research consumers.
Preparing students for this role involves developing their critical thinking skills, thereby
enhancing their understanding of the research process, their appreciation of the role of the critiquer,
and their ability to actually critically appraise research. An undergraduate research course should
develop this basic level of competence, an essential requirement if students are to engage in
evidence-informed clinical decision making and practice, as well as quality improvement activities.
The primary audience for this textbook remains undergraduate students who are learning the
steps of the research process, as well as how to develop clinical questions, critically appraise
published research literature, and use research findings to inform evidence-based clinical practice
and quality improvement initiatives. This book is also a valuable resource for students at the
master’s, DNP, and PhD levels who want a concise review of the basic steps of the research process,
the critical appraisal process, and the principles and tools for evidence-based practice and quality
improvement.
This text is also an important resource for practicing nurses who strive to use research evidence
as the basis for clinical decision making and development of evidence-based policies, protocols, and
standards or who collaborate with nurse-scientists in conducting clinical research and evidence-
based practice. Finally, this text is an important resource for considering how evidence-based
practice, quality improvement, and interprofessional collaboration are essential competencies for
students and clinicians practicing in a transformed health care system, where nurses and their
interprofessional team members are accountable for the quality and cost-effectiveness of care
provided to their patient population. Building on the success of the eighth edition, we reaffirm our
commitment to introducing evidence-based practice, quality improvement processes, and research
principles to baccalaureate students, thereby providing a cutting-edge, research consumer
foundation for their clinical practice. Nursing Research: Methods and Critical Appraisal for Evidence-
Based Practice prepares nursing students and practicing nurses to become knowledgeable nursing
14
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.
• Including an exciting chapter on the role of theory in research and evidence-based practice.
• 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.
• Promoting a lively spirit of inquiry that develops critical thinking and critical reading skills,
facilitating mastery of the critical appraisal process.
• 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.
• 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.
15
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
16
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.
17
To the student
Geri LoBiondo-Wood, Geri.L.Wood@uth.tmc.edu, Judith Haber, jh33@nyu.edu
We invite you to join us on an exciting nursing research adventure that begins as you turn the first
page of the ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based
Practice. The adventure is one of discovery! You will discover that the nursing research literature
sparkles with pride, dedication, and excitement about the research dimension of professional
nursing practice. Whether you are a student or a practicing nurse whose goal is to use research
evidence as the foundation of your practice, you will discover that nursing research and a
commitment to evidence-based practice positions our profession at the forefront of change. You will
discover that evidence-based practice is integral to being an effective member of an
interprofessional team prepared to meet the challenge of providing quality whole person care in
partnership with patients, their families/significant others, as well as with the communities in which
they live. Finally, you will discover the richness in the “Who,” “What,” “Where,” “When,” “Why,”
and “How” of nursing research and evidence-based practice, developing a foundation of
knowledge and skills that will equip you for clinical practice and making a significant contribution
to achieving the Triple Aim, that is, contributing to high quality and cost-effective patient outcomes
associated with satisfying patient experiences!
We think you will enjoy reading this text. Your nursing research course will be short but filled
with new and challenging learning experiences that will develop your evidence-based practice
skills. The ninth edition of Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice
reflects cutting-edge trends for developing evidence-based nursing practice. The four-part
organization and special features in this text are designed to help you develop your critical
thinking, critical reading, information literacy, interprofessional, and evidence-based clinical
decision-making skills, while providing a user-friendly approach to learning that expands your
competence to deal with these new and challenging experiences. The companion Study Guide, with
its chapter-by-chapter activities, serves as a self-paced learning tool to reinforce the content of the
text. The accompanying Evolve website offers review questions to help you reinforce the concepts
discussed throughout the book.
Remember that evidence-based practice skills are used in every clinical setting and can be applied
to every patient population or clinical practice issue. Whether your clinical practice involves
primary care or critical care and provides inpatient or outpatient treatment in a hospital, clinic, or
home, you will be challenged to apply your evidence-based practice skills and use nursing research
as the foundation for your evidence-based practice. The ninth edition of Nursing Research: Methods
and Critical Appraisal for Evidence-Based Practice will guide you through this exciting adventure,
where you will discover your ability to play a vital role in contributing to the building of an
evidence-based professional nursing practice.
18
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.
19
PA R T I
Overview of Research and Evidence-Based
Practice
Research Vignette: Terri Armstrong
OUTLINE
Introduction
20
Introduction
Research vignette
With a little help from my friends
Terri Armstrong, PhD ANP-BC, FAANP, FAAN
Senior Investigator
Neuro-Oncology Branch
National Cancer Institute
National Institute of Health
Bethesda, Maryland
I grew up surrounded by family and strong role models of women working in health care in a
small town in Ohio. When in college, the three most important women in my life (my mom,
grandmother, and great-grandmother) were all diagnosed with cancer. This led me to seek out a
nursing position in oncology, and over time, I was able to be actively involved in their care. This
experience taught me so much and led to the desire to do more to make the daily lives of people
with cancer better. After obtaining a master’s in oncology and a postmaster’s nurse practitioner, an
opportunity to work with Dr. M. Gilbert, a well-known caring physician who specialized in the care
and treatment of patients with central nervous system (CNS) tumors and a great mentor, became
available, so my work with people with CNS tumors began.
After several years, I realized that the quality of life of the brain tumor patients and families was
significantly impacted by the symptoms they experienced. Over 80% were unable to return to work
from the time of diagnosis, and their daily lives (and those of their families) were often consumed
with managing the neurologic and treatment-related symptoms. I realized that obtaining my PhD
would be an important step to learn the skills I would need to try to find answers to solve the
problems CNS tumor patients were facing.
At that time, many of the conceptual models identified solitary symptoms and their impact on the
person. I learned from my experience and in caring for patients that symptoms seldom occurred in
isolation and that the meaning the symptoms had for patients’ daily lives was important, as was
learning about the patients’ perception of that impact. I developed a conceptual model to identify
those relationships and guide my research (Armstrong, 2003). My focus since then has been on
patient-centered outcomes research, focusing on the impact of symptoms on the illness trajectory,
tolerance of therapy, and potential to influence survival. My work is never done in isolation. I have
been fortunate to work with research teams, including those who work alongside me and important
collaborators across disciplines and the world. Team research, in which the views of various
disciplines are brought together, is important in every step of research—from the hypothesis to
study design and finally interpretation of the results.
My work is interconnected, but I believe it can be categorized into three general areas:
1. Improving assessment and our understanding of the experience of patients with CNS tumors.
Patients with primary brain tumors are highly symptomatic, with implications for functional status,
and are used in making treatment decisions. I led a team that developed the M.D. Anderson
Symptom Inventory for Brain Tumors (MDASI-BT) (Armstrong et al., 2005; Armstrong et al.,
2006) and spinal cord tumors (MDASI-Spine) (Armstrong, Gning, et al., 2010). We have
completed studies showing that symptoms are associated with tumor progression (Armstrong et
al., 2011). We have also been able to quantify limitations of patients’ functional status (Armstrong
et al., 2015), in a way that caregivers report is congruent with the patient, and have found that
electronic technology (such as iPads) can be used for this (Armstrong et al., 2012). Our work with
the Collaborative Ependymoma Research Organization (CERN, www.cern-foundation.org) has
allowed us to reach out to patients with this rarer tumor to understand the natural history and
impact of the disease and its treatment on patients around the world (Armstrong, Vera-Bolanos,
et al., 2010; Armstrong, Vera-Bolanos, & Gilbert, 2011). Based on these surveys, we have
21
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.
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).
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.
22
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.
23
CHAPTER 1
24
Integrating research, evidence-based practice,
and quality improvement processes
Geri LoBiondo-Wood, Judith Haber
Learning outcomes
KEY TERMS
abstract
clinical guidelines
consensus guidelines
critical appraisal
critical reading
critique
evidence-based guidelines
evidence-based practice
integrative review
levels of evidence
meta-analysis
meta-synthesis
quality improvement
qualitative research
quantitative research
research
systematic review
25
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.
26
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.
27
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
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.
28
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
Example of Critical Appraisal Reading Strategies
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
Paragraphs, hepatitis disproportionately impacts the homeless because of increased risky sexual behaviors and drug use (Stein, Andersen, Robertson, & Gelberg, 2012), along with
Study’s Purpose substandard living conditions (Hennessey, Bangsberg, Weinbaum, & Hahn, 2009).
and Aims
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 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
Review— 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
Concepts 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
Preventable in the prison system—few inmates complete the series (Weinbaum, Sabin, & Santibanez, 2005). In addition, prevention may not be priority.
disease
vaccinations
Homelessness
Authors contend that, although the HBV vaccine is cost-effective, it is underutilized among high-risk (Rich et al., 2003) and incarcerated populations (Hunt & Saab,
2009).
For homeless men on parole, vaccination completion may be affected by level of custody; generally, the higher the level of custody, the higher the risk an inmate poses.
Conceptual The comprehensive health seeking and coping paradigm (Nyamathi, 1989), adapted from a coping model (Lazarus & Folkman, 1984), and the health seeking and coping
Framework 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 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
and Hypotheses factors, situational factors, personal factors, social factors, and health seeking and coping responses.
Subject 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
Recruitment and reducing drug use and recidivism at 6 and 12 months, as well as vaccine completion in eligible subjects.
Accrual
There were four inclusion criteria for recruitment purposes in assessing program efficacy on reducing drug use and recidivism: (1) history of drug use prior to their
latest incarceration, (2) between ages of 18 and 60, (3) residing in the participating RDT program, and (4) designated as homeless as noted on the prison or jail discharge
form.
Procedure The study was approved by the University of California, Los Angeles Institutional Review Board and registered with clinical Trials.gov.
Building upon previous studies, we developed varying levels of peer-coached and nurse-led programs designed to improve HAV/HBV vaccine receptivity at 12-month
follow-up among homeless offenders recently released to parole. See Appendix A for details in the “Interventions” section.
Intervention Several strategies for treatment fidelity included study design, interventionist’s training, and standardization of interventions. See the Interventions section in Appendix
Fidelity A.
HBA, Hepatitis A virus; HBV, hepatitis B virus; RCT, randomized clinical trial.
HIGHLIGHT
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.
29
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Hänen täytyi taas ajatella Dunjaa. Jos Dunja eläisi, tuntuisi moni
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Hän ei voinut käsittää, että elämällä vielä oli niin paljon hyvää
hänelle.
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