Research Methods: A Framework For Evidence-Based Clinical Practice
Research Methods: A Framework For Evidence-Based Clinical Practice
RESEARCH METHODS
A Framework for Evidence-Based
Clinical Practice
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FOREWORD
This research methods textbook distinguishes itself from other textbooks by provid-
ing a unique framework and perspective for users/students to establish the rele-
vancy of research in their clinical practice. Many, if not most, students in profes-
sional preparation allied health care programs view the research methods/statistics
course requirement of the curriculum as an obstacle to be overcome, or at best, as a
necessary evil. Most research methods textbooks promote these notions because of
the way they are presented. Of course, most times they are written by researchers or
statisticians and are absolutely correct in presenting the theoretical underpinnings
and mechanistic applications of the scientific method. They correctly present expla-
nations as to why one type of methodology requires a certain type of statistical
analysis based on the characteristics of the study population, the type of data col-
lected, or the underlying assumptions pertinent to a specific statistical model. So,
while technically beyond reproach, their failure is in establishing how and why re-
search activity and understanding is integral to a professional practice.
In this textbook, the authors appreciate professional realities that have rele-
vancy to professional preparation and the role of research within that preparation.
First, they promote that understanding research is a required competency in allied
health care preparation. That is, most allied health care professionals are going to
be consumers of research literature for the duration of their professional lives.
This is often enforced by continuing education requirements that reflect the un-
derstanding that medical and allied medical bodies of knowledge are ever ex-
panding and/or being refined and must be communicated to clinicians. Thus, at a
minimum, professional preparation programs must provide the opportunity for
the student to establish competencies in reading, critically evaluating, and synthe-
sizing research into their clinical practice.
The reality is that most medical and allied medical professions have accepted
that their disciplines need to follow an evidence-based best practice approach to
clinical practice and professional preparation in order to be effective today. Most
of their professional organizations actively promote through funding and dissem-
ination vehicles this research paradigm. This is not at the exclusion of other valu-
able research paradigms, but rather as an emphasis commensurate with current
disciplinary interest.
The authors have taken these realities and developed the research elements of
this textbook to be professionally relevant to clinical movement practitioners (e.g.,
physical therapists and certified athletic trainers). They use a commonsense-style
presentation of the conceptual and theoretical bases for the clinical research enter-
prise and provide clear examples of application, evaluation, and integration into
clinical practice.
iv
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Foreword v
Part I introduces the reader to the basic tenets of the research enterprise as it
relates to clinical practice. A wonderful chapter is presented on how to read and
evaluate research articles. This is a very pragmatic chapter that highlights the ele-
ments of an article so the reader can critically appraise the quality of the article.
The history of evidence-based clinical practice is presented along with a chapter
about how research can be used to establish best practices. The last chapter in this
section provides an overlay of ethical principles that need to be operative in re-
search and clinical practice enterprises.
Part II has seven chapters that effectively make the case that the conceptual,
elemental parts of research have a role in the reader’s effort to establish an
evidence-based practice. This is accomplished by describing how a reader could
have a clinical question and that the question is what dictates the research
methodology and analysis. One chapter provides the reader with a way to find re-
sources on clinical practice topics and evaluate the quality of the resources.
Another establishes that there is a hierarchy of evidence and the reader needs
to know what level or quality of evidence is important for them to use in their
clinical practice. Several chapters are nicely presented that introduce the most
common types of scientific inquiry and statistical analysis related to evidence-
based practice.
Part III carries this utilitarian presentation approach to the research enterprise
even further. The chapters are organized into clinical categories rather than re-
search method categories. That is, Chapter 13 presents what clinical research
methodology and analysis is appropriate when the reader is trying to find out
about the evaluation and diagnosis of orthopaedic conditions. Chapter 14 is about
screening and prevention of illnesses and injuries and what kinds of clinical re-
search and analysis are appropriate. Chapter 15 presents the research options that
clinical movement practitioners can use to develop evidence about the efficacy of
treatment/intervention options they may want to use. Chapter 16 further devel-
ops the concepts of treatment outcomes and broadens the focus to present com-
mon methods and relevant data analysis techniques. The last two chapters in this
part focus on how to extend research results to a clinical practice and how to or-
ganize many research results into a usable body of clinical evidence.
Parts IV and V provide sections that are unique to this text. But, again, the util-
itarian approach is taken. These sections are “how-to’s” for a clinical movement
practitioner to appreciate how clinical research results are disseminated. As a re-
search consumer, this is important for them to know. Also, the authors provide
some guidance on how to effectively write a funding proposal for a research proj-
ect. Again, many students in professional preparation programs begin to favor the
research element of their discipline and want to become actively involved in devel-
oping and answering their own clinical questions. Finally, the authors provide in-
sight into how clinical evidence can be used in clinical learning and teaching.
The genius of this text is that it is written for clinical professionals to under-
stand and appreciate research elements that are going to positively affect their
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vi Foreword
clinical practice. All the research methodology and analysis contained herein is
within the context of improving clinical outcomes. In other words, the authors il-
lustrate how clinical practice should drive the research enterprise rather than the
converse. In this way, the information becomes relevant to something clinical pro-
fessionals value and are therefore willing to accept and incorporate research com-
petencies in their clinical practice.
PREFACE
viii Preface
APPROACH
The focal point of our approach to research methods is to provide guidance and
direction for students, instructors, and practitioners on how to acquire, read, in-
terpret, assess, and apply research as evidence in clinical practice has not been
provided in traditional research methods textbooks. We tend to view statistical
analysis as the flip side of research methodology, or two sides of the same coin.
We approach the subject matter conceptually and practically. Using a common-
sense style, conceptual and theoretical frameworks are introduced and discussed
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Preface ix
CHAPTER FEATURES
Each chapter of Research Methods provides the following elements to enhance the
usability of the text and offers a fresh approach to research methods for clinical
movement practitioners and students interested in learning about evidence-based
clinical practice:
• Key terms and concepts are bolded throughout the chapter to help the
reader focus their attention on scientific nomenclature and vocabulary es-
sential to a basic understanding of the chapter content and context.
• Chapter objectives detail what the reader will learn in the chapter and
highlight important pedagogical outcomes while also serving as a three-
fold self-assessment for readers (What are some important reasons for me
to read this chapter? How does this knowledge help me prepare to read it?
And, after reading this chapter, can I satisfy this list of learning outcomes?).
Readers are encouraged to make use of the chapter objectives to help guide
their reading and assess their level of reading comprehension.
• Concept checks reinforce important chapter content and purposefully reit-
erate noteworthy theory and viewpoints.
• Examples throughout chapters make concepts easier to grasp and apply to
real-life research and clinical decision-making situations.
• A chapter summary at the end of each chapter provides a comprehensive
review of the chapter and provides a take-home message for the readers.
• A list of key points further elucidates concepts, theories, and viewpoints
presented and elaborated throughout the chapter as both foundation to the
current chapter and groundwork to subsequent chapters, thus presenting a
full-circle approach by reinforcing the importance of key terms, chapter ob-
jectives, concept checks, examples, and the chapter summary within the
textbook.
• Chapter references and suggested readings are provided to aid the reader
with supplemental materials for breadth and depth of knowledge, and
demonstrate appropriate use and formal citation of original sources in em-
pirical research.
• Figures and tables offer illustrations to provide the reader with visual ex-
amples that help support important information detailed in the text.
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x Preface
ORGANIZATION
The book is organized into five parts. Part I (Chapters 1 to 5) is structured as an
opening presentation of underlying conceptual frameworks and theoretical un-
derpinnings in clinical research and evidence-based practice, and an introduction
to the skills for critiquing and analyzing research is introduced. Chapter 1 covers
the concept of empirical research and the basic tenants of research methodology
as a collective paradigm. Chapter 2 provides a guide for how to read research and
offers a framework for evaluating research articles. Chapter 3 introduces the no-
tion of evidence-based clinical practice and explains how to distinguish best prac-
tices. Chapter 4 addresses the historical perspective of evidence-based medicine to
provide lead into the necessity of ethics in research and practice (covered in
Chapter 5).
Part II (Chapters 6 to 12) is organized around the research process in terms of sta-
tistical analyses and the idea of research as evidence. More specifically, this section
addresses how the question drives the methods when seeking answers to clinical
questions, because we are of the pedagogical and theoretical perspectives that it is
difficult to “teach” research methods without simultaneously addressing statistics.
Chapter 6 covers informational sources, search strategies, and critical appraisal of re-
search as evidence. Chapter 7 addresses the issue of hierarchy of evidence. Chapter 8
deals with qualitative inquiry, while Chapter 9 begins to sort out quantitative inquiry.
Chapters 10 and 11 describe research designs and data analysis while introducing the
statistical perspective of research methods. Chapter 10 discusses the fundamentals of
statistical analysis, focusing on validity and reliability of measures. Chapter 11 cov-
ers tests of comparison. Chapter 12 highlights measures of association.
The concepts that are introduced in Parts I and II and then developed and elab-
orated in Part III focuse on clinical research diagnosis, prevention, and treatment. In
this way, Part III (Chapters 13 to 18) is ordered to describe research designs and data
analysis for each type of study, and then provide some examples to illustrate its
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Preface xi
application. Our goal is to address and apply concepts of research methods into pre-
vention, diagnostics, and intervention outcomes. We are of the perspective that
these are the issues at the heart of evidence-based medicine—why disease and in-
jury occur (epidemiology) and what can I, as a clinician, do to prevent the condition
in the patient in my office (clinical epidemiology), etc. Chapter 13 addresses evalu-
ation and diagnosis from the perspective of research methods and data analysis.
Chapter 14 looks at screening and prevention of illness and injuries, again from the
perspective of research methods and data analysis. Chapter 15 explores the notion
of treatment outcomes across the disablement spectrum. Chapter 16 expands on this
and looks at treatment outcomes from the perspective of research methods and data
analysis. Chapter 17 covers the topics of clinical prediction rules and practice guide-
lines. And, Chapter 18 explores the application and usefulness of systematic review
and meta-analysis in evidence-based clinical practice.
Parts IV and V are unique to our book on several levels. The topics covered in
these chapters are uncommon in most traditional textbooks and are even rarely
mentioned in a book on research methods. Part IV (Chapters 19 and 20) is concen-
trated on the dissemination of research. Specifically, Chapter 19 offers guidelines
and suggestions for presenting research findings; and, Chapter 20 offers a detailed
guide with examples for writing the funding proposal. Part V (Chapters 21 and 22)
covers the integration of evidence-based medicine into the education experience.
Chapter 21 explores the notion of evidence in learning and teaching. Chapter 22
wraps up the discussion and comes full circle to revisit the topic of evidence in the
context of the clinical experience.
ADDITIONAL RESOURCES
Research Methods includes additional resources for both instructors and students
that are available on the book’s companion website at http://thePoint.lww.com/
Hurley.
Instructor Resources
Approved adopting instructors will be given access to the following additional
resources:
xii Preface
Student Resources
All purchasers of the textbook can access the searchable Full Text On-line by going
to the Research Methods website at http://thePoint.lww.com/Hurley. See the in-
side front cover of this textbook for more details, including the passcode you will
need to gain access to the website.
ACKNOWLEDGMENTS
No book is the result of any one person’s efforts, yet we accept any mistakes as
ours alone. We would like to thank the following people whose efforts were essen-
tial to this project:
• Our product manager, Meredith Brittain, and her editorial staff for their tal-
ents, continued hard work, patience, and assistance in bringing this vision
to fruition.
• Our reviewers, for their time, feedback, and suggestions for improvement.
• Our contributing authors for their time, expertise, and generous participa-
tion. These include the coauthors of Chapter 20, Amy Henderson-Harr
(Assistant Vice President, Research and Sponsored Programs, State
University of New York College at Cortland) and Allan Shang (Assistant
Professor of Anesthesiology, Duke University School of Medicine, and
Senior Research Scientist, The Fitzpatrick Institute for Photonics, Duke
University Pratt School of Engineering).
• We would also like to acknowledge the following individuals who con-
tributed suggestions for the text: Timothy J. Bryant (Lecturer III, Kinesiology
Department, State University of New York College at Cortland), for his
help with Chapters 5 and 8; Brent Thomas Wilson (Assistant Professor,
Communication Disorders and Sciences Department, State University of
New York College at Cortland), for his help with Chapters 5 and 8; and,
Amy Henderson-Harr, for her help with Chapter 5.
• Our students and patients, past and present. We offer special acknowledg-
ment to the following students for their assistance in this project: Caitlin
Latham, Lauren Lenney, Patrick Sullivan.
• Our contemporaries in education, research, and medicine.
• The many past generations of teachers, clinical researchers, and medical
practitioners who came before us. We have benefited from your countless,
sometimes unrecognized, sacrifices, and your successes and failures paved
the way for evidence-based practice.
We would also like to thank our families and friends for their understanding
and support throughout the many hours during which our work keeps us away
from those most precious parts of our lives: the persons, the times, and the occa-
sions that we cannot recover after they are missed or gone.
97689_FM 12/07/10 5:41 PM Page xiii
CONTENTS
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
PART I
INTRODUCTION TO CLINICAL RESEARCH 1
1 Research: An Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Introduction 4
What Research is and What Research is Not 4
The Role of Theory in Research 7
The Research Process 7
Research and the Clinical Practitioner 14
Chapter Summary 15
Key Points 15
Critical Thinking Questions 16
Applying Concepts 16
REFERENCES 16
SUGGESTED READING 17
xiv Contents
Key Points 40
Critical Thinking Questions 41
Applying Concepts 41
REFERENCES 41
SUGGESTED READING 42
PART II
SEEKING ANSWERS: HOW THE QUESTION
DRIVES THE METHODS 75
6 Finding the Evidence: Informational Sources,
Search Strategies, and Critical Appraisal . . . . . . . . . . . . . . . . . . 77
Introduction 78
Informational Sources and the Reference Librarian 78
Electronic Sources and Databases 79
Search Strategies 80
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Contents xv
xvi Contents
Contents xvii
PART III
CLINICAL RESEARCH: DIAGNOSIS, PREVENTION, AND TREATMENT 213
13 Evaluation and Diagnosis: Research Methods
and Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Introduction 216
Physical Examination Procedures 217
How Can Clinical Research Improve Patient Evaluation? 218
Design of Studies of Diagnostic Testing 219
Assessing Research of Diagnostic Instruments 222
Statistics and Interpretations 224
The Basics—Sensitivity and Specificity 226
Likelihood Ratios 229
Chapter Summary 236
Key Points 236
Critical Thinking Questions 237
Applying Concepts 237
REFERENCES 237
SUGGESTED READING 238
xviii Contents
Contents xix
PART IV
DISSEMINATION OF RESEARCH 327
19 Presentation of Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
Introduction 330
Types of Presentations 330
Chapter Summary 344
Key Points 344
Critical Thinking Questions 344
Applying Concepts 345
REFERENCES 345
PART V
INTEGRATING EVIDENCE-BASED MEDICINE INTO
THE EDUCATIONAL EXPERIENCE 381
21 Evidence in Learning and Teaching . . . . . . . . . . . . . . . . . . . . . 383
Introduction 384
Learning Critical Appraisal 385
Learning and Teaching from a Body of Evidence 387
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xx Contents
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 415
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Reviewers xxi
Reviewers
Diane P. Brown, PhD, OTR
Associate Clinical Professor
School of Occupational Therapy
Texas Woman’s University
Denton, TX
xxii Reviewers