Clinical Practice Guidelines We Can Trust

Visit the link below to download the full version of this book:
https://cheaptodownload.com/product/clinical-practice-guidelines-we-can-trust-fu
ll-pdf-download/
Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the
National Research Council, whose members are drawn from the councils of the National Academy of
Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the
committee responsible for the report were chosen for their special competences and with regard for
appropriate balance.

This study was supported by Contract No. HHSP23320042509XI between the National Academy of
Sciences and the Department of Health and Human Services. Any opinions, findings, conclusions, or
recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the
view of the organizations or agencies that provided support for this project.

International Standard Book Number 0-309-XXXXX-X (Book)

International Standard Book Number 0-309-XXXXX-X (PDF)
Library of Congress Control Number: 00 XXXXXX

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W.,
Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington
metropolitan area); Internet, http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2011 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and
religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of
Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Cover credit: Photograph by Mai Le.

Suggested citation: IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust.
Washington, DC: The National Academies Press.

PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in
scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general
welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to
advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of
Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a
parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing
with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of
Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and
recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent
members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts
under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal
government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is
president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community
of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government.
Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating
agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the
government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies
and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the
National Research Council.

www.national-academies.org

PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

COMMITTEE ON STANDARDS FOR DEVELOPING TRUSTWORTHY

CLINICAL PRACTICE GUIDELINES

SHELDON GREENFIELD (Chair), Donald Bren Professor of Medicine and Executive Director, Health
Policy Research Institute, University of California–Irvine
EARL PHILLIP STEINBERG (Vice Chair), Senior VP, Clinical Strategy, Quality and Outcomes,
WellPoint, Inc., and President and CEO, Resolution Health, Inc., Columbia, MD
ANDREW AUERBACH, Associate Professor of Medicine in Residence, School of Medicine,
University of California–San Francisco
JERRY AVORN, Professor of Medicine, Harvard Medical School and Chief, Division of
Pharmacoepidemiology and Pharmaeconomics, Brigham and Women’s Hospital, Boston, MA
ROBERT S. GALVIN, Chief Executive Officer, Equity Healthcare, and Executive Director, Corporate
Private Equity, The Blackstone Group
RAYMOND GIBBONS, Consultant in CV Disease and Internal Medicine, Mayo Clinic, Rochester, MN
JOSEPH LAU, Director, Tufts EPC, Tufts Medical Center, Boston, MA
MONICA MORROW, Chief, Breast Service and Anne Burnett Windfohr Chair of Clinical Oncology,
Memorial Sloan-Kettering Cancer Center, and Professor of Surgery, Weill Medical College of
Cornell University, New York, NY
CYNTHIA D. MULROW, Senior Deputy Editor, Annals of Internal Medicine, American College of
Physicians, San Antonio, TX
ARNOLD J. ROSOFF, Professor of Legal Studies & Health Care Management, The Wharton School;
Professor of Family Medicine and Community Health, School of Medicine; and Senior Fellow, The
Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA
JOHN SANTA, Director, Consumer Reports Health Ratings Center, Yonkers, NY
RICHARD N. SHIFFMAN, Professor of Pediatrics, Yale School of Medicine, New Haven, CT
WALLY SMITH, Professor and Chair, Division of Quality Health Care, and Scientific Director, Center
on Health Disparities, Virginia Commonwealth University, Richmond, VA
WALTER F. STEWART, Associate Chief Research Officer, Center for Health Research, Geisinger
Health System, Danville, PA
ELLEN STOVALL, Senior Health Policy Advisor, National Coalition for Cancer Survivorship,
Silver Spring, MD
BRIAN L. STROM, Chair and Professor, Department of Biostatistics and Epidemiology, University of
Pennsylvania, Philadelphia, PA
MARITA G. TITLER, Associate Dean, Office of Practice and Clinical Scholarship, University of
Michigan School of Nursing, Ann Arbor, MI

Study Staff

ROBIN GRAHAM, Senior Program Officer, Study Director

DIANNE MILLER WOLMAN, Senior Program Officer (through December 2010)
MICHELLE MANCHER, Research Associate
ALLISON MCFALL, Senior Program Assistant (through August 2010)
JILLIAN LAFFREY, Senior Program Assistant (starting July 2010)
ROGER HERDMAN, Director, Board on Health Care Services

PREPUBLICATION COPY: UNCORRECTED PROOFS

v

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

Consultants

DAVID ATKINS, Director, Quality Enhancement Research Initiative, Veterans Health Administration
RONEN AVRAHAM, Thomas Shelton Maxey Professor of Law, University of Texas School of Law
JONATHAN D. DARER, Medical Director of Clinical Transformation, Innovation, Geisinger Health
System
MARTIN ECCLES, Professor of Clinical Effectiveness and The William Leech Professor of Primary
Care Research, Institute of Health and Society, Newcastle University
JEREMY GRIMSHAW, Director, Clinical Epidemiology Program, Ottawa Hospital Research Institute
J.B. JONES, Research Investigator I, Geisinger Center for Health
MORI KRANTZ, Associate Professor, Cardiology, University of Colorado, Denver Health Medical
Center
WILLIAM SAGE, Vice Provost for Health Affairs and
James R. Dougherty Chair for Faculty Excellence in Law, University of Texas–Austin
ANNE SALES, Adjunct Professor, Department of Family Medicine, Faculty of Medicine and Dentistry,
University of Alberta
HOLGER SCHÜNEMANN, Chair, Department of Clinical Epidemiology & Biostatistics, McMaster
University
PAUL SHEKELLE, Medical Center Director, Quality Assessment and Improvement Program, RAND
Health
DEAN SITTIG, Professor, School of Biomedical Informatics, UT–Memorial Hermann Center for
Healthcare Quality & Safety, University of Texas Health Science Center at Houston
LEIF SOLBERG, Director for Care Improvement Research, HealthPartners Research Foundation
STEVE WOOLF, Director, VCU Center on Human Needs, Professor of Family Medicine, Virginia
Commonwealth University

PREPUBLICATION COPY: UNCORRECTED PROOFS

vi

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

REVIEWERS

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and
technical expertise, in accordance with procedures approved by the National Research Council’s Report
Review Committee. The purpose of this independent review is to provide candid and critical comments
that will assist the institution in making its published report as sound as possible and to ensure that the
report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The
review comments and draft manuscript remain confidential to protect the integrity of the deliberative
process. We wish to thank the following individuals for their review of this report:

JESSE A. BERLIN, Vice President, Epidemiology, Johnson & Johnson Pharmaceutical Research
and Development
RICHARD BERMAN, President and CEO, LICAS
JAKO BURGERS, Senior Researcher, IQ healthcare, Radboud University, Nijmegen Medical
Centre
MAJORIE FUNK, Professor–Adult Advanced Practice Nursing Specialty, Yale School of Nursing
ALAN M. GARBER, Henry J. Kaiser, Jr. Professor and Professor of Medicine, Director, Center for
Health Policy, Director, Center for Primary Care and Outcomes Research, Stanford University
MARGUERITE A. KOSTER, Practice Leader, Technology Assessment and Guidelines Unit,
Kaiser Permanente Southern California
GREG PAWLSON, Executive Vice President, National Committee for Quality Assurance
DAVID RANSOHOFF, Professor of Medicine, Clinical Professor of Epidemiology, Director,
Clinical Research Curriculum (K30), University of North Carolina School of Medicine
CAROL SAKALA, Director of Programs, Childbirth Connection
VINCENZA SNOW, Medical Director, Vaccines, Specialty Care Medical Affairs, Pfizer, Inc.
SHOSHANNA SOFAER, Professor, and Robert P. Luciano Chair of Health Care Policy, Baruch
College, The City University of New York
MARY E. TINETTI, Department of Internal Medicine/Geriatrics
KATRIN UHLIG, Division of Nephrology, Tufts Medical Center
JAMES WEINSTEIN, Director, The Dartmouth Institute for Health Policy and Clinical Practice;
President, The Dartmouth-Hitchcock Clinic; Peggy Y. Thomson Professor in the Evaluative
Clinical Sciences

Although the reviewers listed above have provided many constructive comments and suggestions,
they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the
report before its release. The review of this report was overseen by ENRIQUETA C. BOND of the
Burroughs Wellcome Fund, and MARK R. CULLEN of Stanford University. Appointed by the National
Research Council and the Institute of Medicine, they were responsible for making certain that an
independent examination of this report was carried out in accordance with institutional procedures and
that all review comments were carefully considered. Responsibility for the final content of this report
rests entirely with the authoring committee and the institution.

PREPUBLICATION COPY: UNCORRECTED PROOFS

vii

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

FOREWORD

Many factors enter into health care decisions. What alternatives are available? What does the
evidence suggest about their potential benefits and harms? How firm is the evidence? Is there reason to
adjust expectations based on a particular patient’s age, gender, race, co-morbidities, or other attributes?
How might different patient preferences affect the best choice for a particular patient? Are there any
social, economic or other practical considerations that could affect the results of a particular care option?
Clinical Practice Guidelines (CPGs) are intended to provide a systematic aid to making such complex
medical decisions. When rigorously developed using a transparent process that combines scientific
evidence, clinician experiential knowledge and patient values, CPGs have the potential to improve many
clinician and patient healthcare decisions, and enhance healthcare quality and outcomes.
The present state of CPG development has yet to fully meet this promise. At the request of the U.S.
Congress, the Institute of Medicine (IOM) undertook this study to develop a set of standards for
developing rigorous, trustworthy clinical practice guidelines. The proposed standards cover a number of
elements essential to developing sound practice guidelines, including: transparency; conflict of interest;
guideline development group composition; CPG–SR intersection; establishing evidence foundations for
and strength of recommendations; articulation of recommendations; external review; and updating. This
report and the eight proposed standards it contains are intended to reinforce the work of numerous
researchers, developers and users of guidelines. This report clarifies where evidence and expert consensus
buttress best CPG development practices, and where there is still much to learn. We hope and expect
these standards to be pilot-tested, assessed for reliability and validity, evaluated for effectiveness, and to
evolve as science and experience dictate.
I want to thank the excellent committee who conducted this work, ably led by Sheldon Greenfield,
chair, and Earl Steinberg, vice chair. The committee was assisted by dedicated IOM staff led by Robin
Graham. A companion report will set out standards for conducting systematic reviews of comparative
effectiveness research. I hope that these reports together will advance the state of the art of systematic
review and clinical practice guideline development, and contribute to a more transparent, scientifically
rigorous, and patient-centered health care system in the United States.

Harvey V. Fineberg, M.D., Ph.D.

President, Institute of Medicine
February 2011

PREPUBLICATION COPY: UNCORRECTED PROOFS

ix

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

PREFACE

In the early 1990s, the Institute of Medicine (IOM) issued several reports on clinical practice
guidelines (CPGs). In the ensuing years, CPGs and guideline development groups have proliferated
enormously to the point that the Agency for Healthcare Research and Quality’s National Guideline
Clearinghouse contains nearly 2,700 CPGs. Parallel growth in CPGs has occurred in other countries; the
Guidelines International Network’s database currently lists more than 6,800 CPGs.
Although the numbers of CPGs and CPG developers have increased substantially, our understanding
of the impact of CPGs on clinical practice and patient outcomes is limited. However, research has shown
that CPGs have the potential to reduce inappropriate practice variation, enhance translation of research
into practice, and improve healthcare quality and safety. CPGs also have had an important influence on
development of physician and hospital performance measures. The data gathered from use of such
measures have provided consumers with information on the quality of different healthcare providers and,
in some instances, provided physicians and hospitals with an economic incentive to improve quality of
care.
At the same time, there has been considerable concern expressed by physicians, consumer groups,
and other stakeholders about the quality of the processes supporting development of CPGs, and the
resulting questionable validity of many CPGs and CPG-based clinical performance measures.
Specifically, this concern extends from limitations in the scientific evidence base on which CPGs rely; a
lack of transparency of development groups’ methodologies; conflict of interest among guideline
development group members and funders; and questions regarding how to reconcile conflicting
guidelines. In light of these challenges, and in response to the growing demand for insight into the quality
of care being delivered in conjunction with rising healthcare costs and the strong indications of the need
to improve clinical decision making and healthcare quality, a provision was included in the Medicare
Improvements for Patients and Providers Act of 2008. It directed the IOM to form two separate, but
related, committees to develop standards for systematic reviews (SRs) of comparative effectiveness
research and for CPGs. If standards for development of valid SRs and CPGs were available, then
clinicians and the public should have greater trust in standards-based CPGs and clinical performance
measures founded on them. Standards for development of trustworthy CPGs additionally could foster the
easier translation of guidelines into electronic forms of clinical decision support.
When the CPG committee was formed, we regarded the charge as more or less updating the state of
the art based on accumulated experience and advances in thinking. As we delved into our work, however,
we recognized that the rapid growth of CPG development efforts had resulted in substantial variation in
CPG development processes. If CPGs were to have their intended impacts, there was a pressing need for
standards regarding many dimensions of guideline development, including the potential for conflict of
interest; the importance of transparency of the guideline development process; the appropriate type and
level of patient and public input into the CPG development process; the need for clarity regarding the
reasoning supporting each CPG recommendation; the approaches used to rate the quality of evidence
underlying and strength of each CPG recommendation; the need to ensure that CPGs take account of
patients with coexisting conditions; and the relationship between individuals who develop a guideline and
those who perform SRs on topics relevant to the CPG. The committee found no existing set of standards
that addressed all of the above elements or offered prospective guidance for developing high-quality,
trustworthy CPGs. Thus, the committee proposes its own standards.
The diversity of talents and experiences of the committee members made our task more complicated
and challenging than we had anticipated, but ultimately resulted in a highly thoughtful, rich report.
Academicians from a variety of disciplines, experts from various types of stakeholder entities, and a
diverse array of individuals involved in guideline development and implementation participated in our
deliberations and contributed to this report. More than 2,500 publications were reviewed by staff and
committee members; a public forum was conducted for organizations that develop and want to use CPGs;
and several papers were commissioned to enable the committee to gain as much perspective as possible.

PREPUBLICATION COPY: UNCORRECTED PROOFS

xi

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

The extraordinary efforts of Robin Graham, Study Director, and Michelle Mancher and Dianne Wolman
made the task possible.
The two of us express our great appreciation to the committee members and staff for their
commitment, effort, dedication, and wisdom. The spirited discussions during meetings and the frequent
communications between meetings all contributed to this report. We hope the committee’s findings and
proposed standards and recommendations will foster trustworthy CPGs that increase quality of care and
improve patient outcomes.

Sheldon Greenfield, Chair

Earl Phillip Steinberg, Vice Chair
Committee on Standards for Developing
Trustworthy Clinical Practice Guidelines

PREPUBLICATION COPY: UNCORRECTED PROOFS

xii

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

ACKNOWLEDGMENTS

The committee and staff are indebted to a number of individuals and organizations for their
contributions to this report. The following individuals testified before the committee during public
meetings or workshops:

Workshop Participants
William G. Adams, American Academy of Pediatrics
David Atkins, Veterans Administration
Michael Bettmann, American College of Radiology
Zobeida Bonilla, Our Bodies Ourselves
Kent Bottles, Institute for Clinical Systems Improvement
Cynthia Boyd, Physician Expert in Multimorbidity, Johns Hopkins Department of Medicine
Arleen Brown, Physician Expert in Health Disparities, UCLA Internal Medicine
Vivian Coates, National Guideline Clearinghouse/ECRI Institute
Joyce Dubow, AARP
Laura Fochtmann, American Psychiatric Association
Ted Ganiats, American Academy of Family Physicians
Alice Jacobs, American College of Cardiology and American Heart Association
Louis B. Jacques, Centers for Medicare & Medicaid Services
Richard Kahn, Former Chief Scientific and Medical Officer of the American Diabetes Association
Karen Kelly-Thomas, National Association of Pediatric Nurse Practitioners
Marguerite Koster, Kaiser Permanente Southern California
Sandra Zelman Lewis, American College of Chest Physicians
Joan McClure, National Comprehensive Cancer Network
Elizabeth Mort, Quality and Safety, Massachusetts General Hospital, Massachusetts General Physicians
Organization
Jim Schibanoff, Milliman Care Guidelines
Nita L. Siebel, National Cancer Institute
Denise Simons-Morton, National Heart, Lung, and Blood Institute
Vincenza Snow, American College of Physicians
Katrin Uhlig, Tufts Medical Center, Boston

Public Forum Testifiers

Ethan Basch, American Society of Clinical Oncology
Christopher Bever, American Academy of Neurology
Terrie Cowley, The TMJ Association
Steven Findlay, Consumers Union
Merrill Goozner, Health Tech Review/GoozNews.com
David Paul Harries, International Spine Intervention Society
Belinda Ireland, BJC HealthCare
Norman Kahn, Council of Medical Specialty Societies
Lisa Mojer-Torres, Chair, Citizens’ Advisory Council for the Division of Addiction Services, State of
New Jersey
Katherine Nordal, American Psychological Association
Jennifer Padberg, Infectious Diseases Society of America (IDSA)
William Rich, American Academy of Ophthalmology
Richard Rosenfeld, American Academy of Otolaryngology–Head and Neck Surgery
Kathleen Sazama, Society for the Advancement of Blood Management (SABM)
Aryeh Shander, Society for the Advancement of Blood Management (SABM)
Christopher Wolfkiel, American College of Occupational and Environmental Medicine (ACOEM)

PREPUBLICATION COPY: UNCORRECTED PROOFS

xiii

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

Diana Zuckerman, National Research Center for Women & Families

We also extend special thanks to the following individuals who were essential sources of information,
generously giving their time and knowledge to further the committee’s efforts.

Josh Adler, Vice President, Business Development, Archimedes, Inc.

Ned Calogne, Chief Medical Officer, Colorado Department of Public Health and Environment
Paul Chrisp, Associate Director, Accreditation, NHS Evidence, NICE
David Eddy, Founder, Archimedes, Inc.
Jeremy Grimshaw, Director, Clinical Epidemiology Program, Ottawa Hospital Research Institute
Richard Grol, Chair, Department of Quality of Care, Radboud University Nijmegen; Director, Centre for
Quality of Care Research (WOK)
Russell Harris, Professor of Medicine, Adjunct Professor of Epidemiology, Division of General
Medicine, University of North Carolina at Chapel Hill
Greg Pawlson, Executive Vice President, NCQA
David Ransohoff, Professor of Medicine, Clinical Professor of Epidemiology, Director, Clinical Research
Curriculum, University of North Carolina School of Medicine
Holger Schünemann, Chair, Department of Clinical Epidemiology & Biostatistics, McMaster University

Funding for this study was provided by the Agency for Healthcare Research and Quality (AHRQ).
The committee appreciates the opportunity and support extended by AHRQ for the development of this
report.
Finally, many within the IOM were helpful to the study staff. We especially would like to thank
Jillian Laffrey, a new member of our staff, for her great ingenuity and dedication, and the staff of the
Systematic Reviews report for their insight and cooperation: Jill Eden, Lea Binder, Mai Le, and Laura
Levit. Additionally, the staff would like to thank Clyde Behney, Greta Gorman, Cheryl Levey, William
McLeod, Abbey Meltzer, Vilija Teel, and Lauren Tobias.

PREPUBLICATION COPY: UNCORRECTED PROOFS

xiv

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

CONTENTS

SUMMARY 1

1 INTRODUCTION 11
Building on Previous IOM Studies 11
Current State of Clinical Practice Guidelines 14
Study Scope 15
Purpose and Updated Definition of Clinical Practice Guidelines 18
Organization of Report 19

2 BACKGROUND AND KEY STAKEHOLDERS IN GUIDELINES DEVELOPMENT 21

AND USE
Background 21
Current Major Stakeholders in Guidelines Development and Use 25

3 TRUSTWORTHY CLINICAL PRACTICE GUIDELINES: CHALLENGES AND 39

POTENTIAL
Introduction 39
Development of Evidence-Based CPGs 39
Empirical Assessment of Guideline Development Methodology 46
Standardizing Guideline Development Quality Appraisal 47

4 CURRENT BEST PRACTICES AND PROPOSED STANDARDS FOR DEVELOPMENT 57

OF TRUSTWORTHY CPGS: PART I GETTING STARTED
Introduction 57
Establishing Transparency 57
Management of Conflict of Interest 59
Guideline Development Group Composition and Group Process 63
Clinical Practice Guideline–Systematic Review Intersection 69
Determining Guideline Scope and Requisite Chain of Logic

5 CURRENT BEST PRACTICES AND STANDARDS FOR DEVELOPMENT OF 83

TRUSTWORTHY CPGS: PART II, TRAVERSING THE PROCESS
Introduction 83
Establishing Evidence Foundations for and Rating Strength of Recommendations 83
Articulation of Recommendations 96
External Review 98
Updating 100
Conclusion 103

6 PROMOTING ADOPTION OF CLINICAL PRACTICE GUIDELINES 111

Introduction 111
Strategies for Implementation of CPG Recommendations 112
Electronic Interventions for CPG Implementation 122
Decision Analytic Modeling and CPG Implementation 129
Legal Issues Affecting CPG Implementation 129

PREPUBLICATION COPY: UNCORRECTED PROOFS

xv

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

7 DEVELOPMENT, IDENTIFICATION, AND EVALUATION OF TRUSTWORTHY 143

CLINICAL PRACTICE GUIDELINES
Introduction 143
Who Should Develop Guidelines? 143
Should There Be a Process to Identify CPGs That Meet the Proposed Trustworthy Standards? 145
Is There a Continuing Need for a Guideline Clearinghouse? 149
Should There Be a Process to Harmonize Related CPGs? 150
Should There Be a Process to Identify Which Recommendations Should Be Considered for 151
Quality Measures?
How Should CPG Development and Implementation Processes and Impact Be Evaluated? 152

APPENDIXES
A Abbreviations and Acronyms 155
B Workshop Agenda and Questions to Panelists 159
C Clinical Practice Guideline Appraisal Tools 163
D Systems for Rating the Strength of Evidence and Clinical Recommendations 175
E Literature Search Strategy: Clinical Practice Guidelines 189
F Committee Biographies 191

PREPUBLICATION COPY: UNCORRECTED PROOFS

xvi

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

BOXES, TABLES, AND FIGURES

Chapter 1

Box
1-1 Recommended Attributes of CPGs 13

Chapter 2

Box
2-1 Criteria for Inclusion in The National Guideline Clearinghouse (NGC) 31

Chapter 3

Boxes
3-1 Infectious Diseases Society of America Lyme Disease Guidelines (2006) 42
3-2 Colorectal Cancer Screening Guidelines (2008) 43
3-3 National Kidney Foundation’s Kidney Disease and Outcomes Quality Initiative Anemia 44
Management Guidelines (2006)

Chapter 4

Table
4-1 Models of Interaction Between Clinical Practice Guideline (CPG) Groups and Systematic 70
Review (SR) Teams

Figure
4-1 Analytic framework and KQs 74

Chapter 5

Box
5-1 Guidelines with Conflicting Recommendations 90

Table
5-1 Interpretation of the American College of Physicians’ Guideline Grading System 88

Chapter 6

Tables
6-1 CDS Types and Features 124
6-2 CDSC Guidance for CPG Development Activities 128

Figure
6-1 Implementation model 113

PREPUBLICATION COPY: UNCORRECTED PROOFS

xvii

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

Summary
Clinicians can no longer stay abreast of the rapidly expanding knowledge bases related to
health. The number of randomized controlled trials published in MEDLINE (a medical literature
database) grew from 5,000 per year in 1978–1985 to 25,000 per year in 1994–2001. Further-
more, contentions that much of the literature may be biased and not applicable to important sub-
sets of target populations have caused its quality to be suspect. Overall, clinicians increasingly
are barraged with a vast volume of evidence of uncertain value. Hence, critically appraised and
synthesized scientific evidence has become fundamental to clinical practice. At the same time,
and particularly under conditions of uncertainty regarding optimal decisions, clinician experien-
tial knowledge and skill (the “art of medicine”) and patient values and preferences remain essen-
tial contributors to quality healthcare practice, in a complex interplay with science.
Clinical practice guidelines (CPGs) embody and support the interrelationships among these
critical contributors to clinical decision making. Rather than dictating a one-size-fits-all approach
to patient care, CPGs are able to enhance clinician and patient decision making by clearly de-
scribing and appraising the scientific evidence and reasoning (the likely benefits and harms) be-
hind clinical recommendations, making them relevant to the individual patient encounter.
Although it remains important for CPGs to be evaluated fully for their effectiveness in im-
proving health, when rigorously developed, they have the power to translate the complexity of
scientific research findings into recommendations for clinical practice and potentially enhance
healthcare quality and outcomes. However, the current state of CPG development has yet to meet
this potential.

CPG DEVELOPMENT CHALLENGES

Clinical practice guidelines are ubiquitous in our healthcare system. The Guidelines Interna-
tional Network database currently lists more than 3,700 guidelines from 39 countries. Its U.S.
counterpart, the National Guideline Clearinghouse (NGC), accepted 722 guidelines to its data-
base in 2008 alone, so that its total collection is nearly 2,700. CPG developers and users are cha-
racterized by varied organizations such as clinical specialty societies, disease advocacy groups,
federal and local agencies, health plans, and commercial companies. However, CPGs suffer from
shortcomings in the guideline development process, often compounding limitations inherent in
their scientific evidentiary bases. Certain factors commonly undermine the quality and trustwor-
thiness of CPGs. These include: variable quality of individual scientific studies; limitations in
systematic reviews (SRs) upon which CPGs are based; lack of transparency of development
groups’ methodologies (particularly with respect to evidence quality and strength of recommen-
dation appraisals); failure to convene multi-stakeholder, multi-disciplinary guideline develop-
ment groups and corresponding non-reconciliation of conflicting guidelines; unmanaged con-
flicts of interest (COI); and overall failure to use rigorous methodologies in CPG development.
Furthermore, evidence supporting clinical decision making and CPG development relevant to
subpopulations, such as patients with comorbidities, the socially and economically disadvan-
taged, and those with rare conditions, is usually absent.

1
PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

2 CLINICAL PRACTICE GUIDELINES WE CAN TRUST

More generally, the quality of CPG development processes and guideline developer adhe-
rence to quality standards have remained unsatisfactory and unreliable for decades. Non-
standardized development results in substantial variation in clinical recommendations. At the
same time, CPGs produced within a structured environment, in which a systematic procedure or
“Guidelines for Guidelines” are available to direct production are more likely to be of higher
quality. Furthermore, documentation of guideline development is enhanced by developer use of
appraisal instruments or tools for systematically assessing and reporting the quality of guideline
development processes. While uniformly endorsed standards for clinical practice guidelines de-
velopment do not yet exist, there appears to be widespread agreement regarding elements basic
to quality CPG development.
The concept that quality standards should inform CPG development is a pervasive concern
globally, underscored by increasing calls for international standards to hasten rigorous CPG de-
velopment and appraisal. Although a number and variety of guideline development appraisal
tools (e.g. The Appraisal of Guidelines for Research and Evaluation [AGREE] Tool), which
point to standards, are available, they inadequately reflect the full range of quality CPG devel-
opment. They commonly focus on development process and form, with only a small number at-
tending to the quality of evidence and the strength of recommendations. Furthermore, COI, the
role of judgment in the derivation of recommendations, prioritization of the recommendations,
development group composition, and how to assure patient-centeredness all lack sufficient atten-
tion in current standards for CPG development. These appraisal tools also are not designed for
prospective application to guideline development. There are no agreed-on standards for prospec-
tive enhancement of high-quality, trustworthy clinical practice guidelines.

COMMITTEE CHARGE
In 2008, the Institute of Medicine (IOM) report Knowing What Works in Health Care rec-
ommended that the U.S. Secretary of Health and Human Services create a public–private pro-
gram to develop (or endorse) and promote a common set of standards addressing the structure,
process, reporting, and final products of systematic reviews of comparative effectiveness re-
search and evidence-based clinical practice guidelines. Congress, through the Medicare Im-
provements for Patients and Providers Act of 2008, subsequently called on the Secretary to con-
tract with the IOM, through the Agency for Healthcare Research and Quality (AHRQ), to
undertake two studies: (1) to “identify the methodological standard for conducting systematic
reviews of clinical effectiveness research on health and health care in order to ensure that organi-
zations conducting such reviews have information on methods that are objective, scientifically
valid, and consistent,” and (2) to focus on “the best methods used in developing clinical practice
guidelines in order to ensure that organizations developing such guidelines have information on
approaches that are objective, scientifically valid, and consistent.”
The IOM formed two committees, the Committee on Standards for Systematic Reviews of
Comparative Effectiveness Research and the Committee on Standards for Developing Trustwor-
thy Clinical Practice Guidelines, to meet the above requests. The two committees worked inde-
pendently, but in coordination with each other, because the topics were related. While the SR
committee attended exclusively to methods for SR development, from formulation of the re-
search question to derivation of the final report, the CPG committee worked from the premise
that SRs reflecting the methodological standard, as defined by the SR committee, are instrumen-
tal to a trustworthy guideline development process.

PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

SUMMARY 3

The CPG committee defined “standard” as a process, action, or procedure for developing
CPGs that is deemed essential to producing scientifically valid, transparent, and reproducible re-
sults. The committee examined existing standards for guidelines development, assessing whether
any would ensure development of trustworthy clinical practice guidelines. Special attention was
given to standards incorporating systems for appraising quality of evidence and strength of rec-
ommendations. The committee also considered methods for modifying CPGs for patients with
multiple conditions; ways to reduce the number of overlapping guidelines and harmonize CPGs
on the same topic; strategies to promote and evaluate adoption of development standards and
trustworthy CPGs; means to distinguish trustworthy CPGs; and procedures for identifying guide-
line recommendations potentially appropriate for measuring the quality of healthcare systems or
clinicians.

CLINICAL PRACTICE GUIDELINES: A NEW DEFINITION

The literature assessing the best methods for guideline development has evolved dramatically
in the 20 years since the IOM’s first report on the subject, Clinical Practice Guidelines: Direc-
tions for a New Program, which defined CPGs as “systematically developed statements to assist
practitioner and patient decisions about appropriate health care for specific clinical circums-
tances.” The committee saw the need to update this definition, in accordance with the AHRQ
contract, and to better reflect current consensus on what constitutes a CPG, including aspects of
guideline development that the committee believes are defining characteristics. The new defini-
tion is as follows: Clinical practice guidelines are statements that include recommendations
intended to optimize patient care that are informed by a systematic review of evidence and
an assessment of the benefits and harms of alternative care options.
To be trustworthy, guidelines should

• Be based on a systematic review of the existing evidence;

• Be developed by a knowledgeable, multidisciplinary panel of experts and representatives
from key affected groups;
• Consider important patient subgroups and patient preferences, as appropriate;
• Be based on an explicit and transparent process that minimizes distortions, biases, and
conflicts of interest;
• Provide a clear explanation of the logical relationships between alternative care options
and health outcomes, and provide ratings of both the quality of evidence and the strength
of the recommendations; and
• Be reconsidered and revised as appropriate when important new evidence warrants mod-
ifications of recommendations.

The new definition provides a clear distinction between the term “CPG” and other forms of
clinical guidance derived from widely disparate development processes (e.g., consensus state-
ments, expert advice, and appropriate use criteria). Furthermore, it underscores systematic re-
view and both benefits and harms assessment as essential characteristics of CPGs. Although the
committee recognizes that other forms of clinical guidance may have value, addressing those
other forms was beyond the scope of this report. Furthermore, the committee is aware that, for
many clinical domains, high-quality evidence is lacking or even nonexistent. However, even giv-

PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

4 CLINICAL PRACTICE GUIDELINES WE CAN TRUST

en such constraints, guideline developers may still produce trustworthy CPGs if their develop-
ment reflects those committee standards detailed below.

STANDARDS FOR TRUSTWORTHY

CLINICAL PRACTICE GUIDELINES
As enumerated below, the committee’s proposed standards reflect the latest literature, expert
consensus, and public comment, and the committee hopes they represent an important advance in
the newest and best practice standards for CPG development. The committee expects its stan-
dards to be assessed for reliability and validity (including applicability), and to evolve as the
science and experience demand. The committee has given increased attention to aspects of COI,
such as details of guideline development group exclusions; aspects of guideline group composi-
tion, including training of patient and consumer representatives in evidence appraisal; the specif-
ic nature of working relationships between systematic review teams and CPG developers; critical
steps in establishing evidence foundations for clinical recommendations and rating recommenda-
tions’ strength; external review of the CPG, including specified mechanisms for ensuring public
stakeholder comment; and elements essential to CPG updating, including ongoing monitoring
and review of the CPG-relevant scientific literature and factors indicating the need for updates.
The eight standards extend across the development process from conception to completion to
revision. The standards should provide sufficient flexibility to be applicable to all guideline de-
velopment groups (whether evidence in a particular clinical area is lacking or abundant), unlike
many development methodologies, which are specific to a particular guideline development enti-
ty and clinical problem. The committee’s eight proposed standards follow.

Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs)

1) Establishing Transparency
1.1 The processes by which a CPG is developed and funded should be detailed explicitly and
publicly accessible.
2) Management of Conflict of Interest (COI)
2.1 Prior to selection of the guideline development group (GDG), individuals being considered
for membership should declare all interests and activities potentially resulting in COI with
development group activity, by written disclosure to those convening the GDG:
• Disclosure should reflect all current and planned commercial (including services from
which a clinician derives a substantial proportion of income), non-commercial, intellec-
tual, institutional, and patient–public activities pertinent to the potential scope of the
CPG.
2.2 Disclosure of COIs within GDG:
• All COI of each GDG member should be reported and discussed by the prospective de-
velopment group prior to the onset of his or her work.
• Each panel member should explain how his or her COI could influence the CPG devel-
opment process or specific recommendations.
2.3 Divestment
• Members of the GDG should divest themselves of financial investments they or their
family members have in, and not participate in marketing activities or advisory boards
of, entities whose interests could be affected by CPG recommendations.

PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.

Clinical Practice Guidelines We Can Trust
http://www.nap.edu/catalog/13058.html

SUMMARY 5

2.4 Exclusions
• Whenever possible GDG members should not have COI.
• In some circumstances, a GDG may not be able to perform its work without members
who have COIs, such as relevant clinical specialists who receive a substantial portion of
their incomes from services pertinent to the CPG.
• Members with COIs should represent not more than a minority of the GDG.
• The chair or co-chairs should not be a person(s) with COI.
• Funders should have no role in CPG development.
3) Guideline Development Group Composition
3.1 The GDG should be multidisciplinary and balanced, comprising a variety of methodological
experts and clinicians, and populations expected to be affected by the CPG.
3.2 Patient and public involvement should be facilitated by including (at least at the time of clin-
ical question formulation and draft CPG review) a current or former patient, and a patient
advocate or patient/consumer organization representative in the GDG.
3.3 Strategies to increase effective participation of patient and consumer representatives, in-
cluding training in appraisal of evidence, should be adopted by GDGs.
4) Clinical Practice Guideline–Systematic Review Intersection
4.1 Clinical practice guideline developers should use systematic reviews that meet standards set
by the Institute of Medicine’s Committee on Standards for Systematic Reviews of Compara-
tive Effectiveness Research.
4.2 When systematic reviews are conducted specifically to inform particular guidelines, the
GDG and systematic review team should interact regarding the scope, approach, and out-
put of both processes.
5) Establishing Evidence Foundations for and Rating Strength of Recommendations
5.1 For each recommendation, the following should be provided:
• An explanation of the reasoning underlying the recommendation, including:
o A clear description of potential benefits and harms.
o A summary of relevant available evidence (and evidentiary gaps), description of
the quality (including applicability), quantity (including completeness), and con-
sistency of the aggregate available evidence.
o An explanation of the part played by values, opinion, theory, and clinical expe-
rience in deriving the recommendation.
• A rating of the level of confidence in (certainty regarding) the evidence underpinning
the recommendation.
• A rating of the strength of the recommendation in light of the preceding bullets.
• A description and explanation of any differences of opinion regarding the recommenda-
tion.
6) Articulation of Recommendations
6.1 Recommendations should be articulated in a standardized form detailing precisely what the
recommended action is, and under what circumstances it should be performed.
6.2 Strong recommendations should be worded so that compliance with the recommendation(s)
can be evaluated.
7) External Review
7.1 External reviewers should comprise a full spectrum of relevant stakeholders, including
scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies
(e.g., federal government), patients, and representatives of the public.
7.2 The authorship of external reviews submitted by individuals and/or organizations should be
kept confidential unless that protection has been waived by the reviewer(s).
7.3 The GDG should consider all external reviewer comments and keep a written record of the
rationale for modifying or not modifying a CPG in response to reviewers’ comments.

PREPUBLICATION COPY: UNCORRECTED PROOFS

Copyright © National Academy of Sciences. All rights reserved.