WASHINGTON — Clinical practice guidelines and systematic reviews of the evidence base for health care services are supposed to offer health care providers, patients, and organizations authoritative guidance on the comparable pros and cons of various care options, but too often they are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews and clinical practice guidelines, leading to variability in the handling of conflicts of interest, appraisals of evidence, and the rigor of the evaluations. Two new reports from the Institute of Medicine recommend standards to enhance the quality and reliability of these important tools for informing health care decisions (see illustration).
Clinical Practice Guidelines We Can Trust recommends eight standards to ensure the objective, transparent development of trustworthy guidelines. Several problems hinder providers' and others' ability to determine which among thousands of sometimes competing guidelines offer reliable clinical recommendations. Finding What Works in Health Care: Standards for Systematic Reviews recommends 21 standards to ensure objective, transparent, and scientifically valid reviews. Poor quality reviews can lead clinicians to the wrong conclusions and ultimately to inappropriate treatment decisions.
"These standards are necessary given that there is little documentation to judge the quality and reliability of many of the existing clinical practice guidelines," said Sheldon Greenfield, Donald Bren Professor of Medicine and executive director, Health Policy Research Institute, University of California, Irvine, and chair of the committee on guidelines. "Practice guidelines provide valuable data and guidance that not only inform individual decisions about care but ultimately could also improve overall health care quality and outcomes."
"This report presents the 'gold standard' to which those who conduct systematic reviews should aspire to achieve the most reliable and useful products," said Alfred O. Berg, professor of family medicine, University of Washington School of Medicine, Seattle, and chair of the committee that wrote the report on systematic reviews. "We recognize that it will take an investment of resources and time to achieve such high standards, but they should be adopted to minimize the chances that important health decisions are based on information that may be biased or erroneous."
To prevent actual or perceived conflicts of interest from eroding trust in clinical practice guidelines, members of guideline development groups should not have intellectual, institutional, financial, or other forms of conflicts whenever possible, says the guidelines report. However, if a group cannot perform its work without conflicted individuals, they should make up only a minority of the members. Those who fund guideline development work should have no role in the development process. Similarly, individuals with clear financial conflicts of interest as well as those with professional or intellectual biases that would lessen an evaluation's credibility should be excluded from the teams that conduct systematic reviews, the report on reviews says.
Getting input from consumers, health professionals, insurers, and other intended users can boost the quality of reviews and guidelines and make them more relevant. Guideline development groups should include a current or former patient and a patient advocate or representative of a consumer organization. Systematic reviews should include a method to collect information from individuals with relevant perspectives and expertise. Individuals providing input should publicly acknowledge their potential biases and conflicts and be excluded from the process if their participation would diminish the evaluation's credibility.
People expect clinical practice guidelines to provide an accurate, fair account of the potential benefits and harms of various health care options and they expect systematic reviews to provide a complete picture of all that is known about an intervention. Because guideline developers often have to make subjective judgments about evidence, especially when it is low-quality or limited, they should explicitly describe the part that value judgments, theory, or clinical experience played in their recommendations, the guidelines report says. They should explain the reasoning underlying each recommendation they make, including their assessment of the quality, completeness, and consistency of the available evidence. Teams conducting systematic reviews should not limit their evaluations to the published literature or large databases because negative findings sometimes go unpublished and these tools provide only a partial picture of the evidence, the report on reviews says. Reviewers should seek out relevant unpublished information. And they should clearly describe the team's methodology, selection criteria, and assessment of the evidence, including what remains unknown about the topic.
The studies were requested by Congress and sponsored by the U.S. Department of Health and Human Services. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. For more information, visit http://national-academies.org or http://iom.edu. Committee rosters follow.
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Additional resources: Report Brief for Practice Guidelines Report Brief for Systematic Reviews Illustration Practice Guidelines Website Systematic Reviews Website
Pre-publication copies of Finding What Works in Health Care: Standards for Systematic Reviews and Clinical Practice Guidelines We Can Trust are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Additional information is available at http://www.iom.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
INSTITUTE OF MEDICINE
Board on Health Care Services
Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Sheldon Greenfield, M.D. (chair)
Donald Bren Professor of Medicine
and Executive Director
Health Policy Research Institute
University of California
Irvine
Earl P. Steinberg, M.D., M.A. (vice chair)
Senior Vice President of Clinical Strategy, Quality, and Outcomes
WellPoint Inc., and
President and CEO
Resolution Health Inc.
Columbia, Md.
Andrew Auerbach, M.D.,
M.P.H.
Associate Professor of Medicine in
Residence
School of Medicine
University of California
San Francisco
Jerry Avorn, M.D.
Professor of Medicine
Harvard Medical School, and
Chief
Division of Pharmacoepidemiology
and Pharmaconomics
Brigham and Women's Hospital Boston
Robert S. Galvin, M.D.
CEO
Equity Healthcare, and
Executive Director
Corporate Private Equity
The Blackstone Group
New York City
Raymond J. Gibbons, M.D.
Consultant in Cardiovascular Disease and Internal Medicine
Mayo Clinic
Rochester, Minn.
Joseph Lau, M.D.
Director
Evidence-Based Practice Center
Tufts Medical Center
Boston
Monica Morrow, M.D.
Chief of Breast Service and Anne Burnett Windfohr Chair of Clinical Oncology
Memorial Sloan-Kettering Cancer Center, and
Professor of Surgery
Weill Medical College
Cornell University
New York City
Cynthia Mulrow, M.D.
Senior Deputy Editor
Annals of Internal Medicine
American College of Physicians
San Antonio
Arnold J. Rosoff, J.D.
Professor of Legal Studies and Health Care Management
The Wharton School;
Professor of Family Medicine and Community Health
School of Medicine; and
Senior Fellow
Leonard Davis Institute of Health Economics
University of Pennsylvania
Philadelphia
John Santa, M.D., M.P.H.
Director
Consumer Reports Health Ratings
Center
Yonkers, N.Y.
Richard N. Shiffman, M.D., M.C.I.S.
Professor of Pediatrics
Yale School of Medicine
New Haven, Conn.
Wally R. Smith, M.D.
Professor and Chair
Division of Quality Health Care, and
Scientific Director
Center on Health Disparities
Virginia Commonwealth University
Richmond
Walter F. Stewart, Ph.D., M.P.H.
Associate Chief Research Officer
Center for Health Research
Geisinger Health System
Danville, Pa.
Ellen L. Stovall, B.A.
Senior Health Policy Adviser
National Coalition for Cancer Survivorship
Silver Spring, Md.
Brian L. Strom, M.D., M.P.H.
Chair and Professor
Department of Biostatistics and
Epidemiology
University of Pennsylvania
Philadelphia
Marita G. Titler, Ph.D., R.N.
Associate Dean
Office of Practice and Clinical
Scholarship
School of Nursing
University of Michigan
Ann Arbor
STAFF
Robin Graham, Ph.D., M.P.H.
Study Director
INSTITUTE OF MEDICINE
Board on Health Care Services
Committee on Standards for Systematic Review of Comparative Effectiveness Research
Alfred O. Berg, M.D., M.P.H. (chair)
Professor
Department of Family Medicine
University of Washington School of Medicine
Seattle
Sally C. Mortom, Ph.D. (vice chair)
Professor and Chair
Department of Biostatistics
Graduate School of Public Health
University of Pittsburgh
Pittsburgh
Jesse Berlin, Ph.D.
Vice President of Epidemiology
Johnson & Johnson Pharmaceutical Research and
Development
Titusville, N.J.
Giselle Corbie-Smith, M.D., M.Sc.
Professor
Departments of Social Medicine and Medicine
School of Medicine
University of North Carolina
Chapel Hill
Kay Dickersin, M.A., Ph.D.
Professor of Epidemiology, and
Director
Center for Clinical Trials and U.S. Cochrane Center
Johns Hopkins Bloomberg School of Public Health
Baltimore
Jeremy Grimshaw, M.B.Ch.B., Ph.D.
Senior Scientist
Clinical Epidemiology Program
Ottawa Hospital Research Center, and
Director
Center for Best Practice
Institute of Population Health
University of Ottawa
Ottawa, Ontario
Mark Helfand, M.D., M.S., M.P.H.
Professor of Medicine and Medical Informatics and Clinical Epidemiology, and
Director
Oregon Evidence-Based Practice Center
Oregon Health and Science University
Portland
Vincent E. Kerr, M.D.
President
Care Solutions
United HealthCare
Fairfield, Conn.
Marguerite Koster, M.A., M.F.T
Practice Leader
Technology Assessment and Guidelines Unit
Southern California Permanente Medical Group
Pasadena, Calif.
Katie Maslow, M.S.W.
Scholar in Residence
Institute of Medicine
Washington, D.C.
David A. Mrazek, M.D., F.R.C.Psych
Chair
Department of Psychiatry and Psychology
Mayo Clinic
Rochester, Minn.
Christopher Schmid, Ph.D.
Director
Biostatistics Research Center
Institute for Clinical Research and Health Policy Studies, and
Professor of Medicine
Tufts Medical Center
Tufts University
Boston
Anna Maria Siega-Riz, Ph.D.
Professor of Epidemiology and Nutrition, and
Associate Chair of Epidemiology
Gillings School of Global Public Health
University of North Carolina
Chapel Hill
Harold C. Sox, M.D.
Editor Emeritus
Annals of Internal Medicine
American College of Physicians of Internal Medicine
Hanover, N.H.
Paul J. Wallace, M.D.
Medical Director
Health and Productivity Management Programs
The Permanente Federation
Oakland, Calif.
STAFF
Jill Eden
Study Director