Date:  March 23, 2011




IOM Recommends Standards to Achieve Reliable Clinical Practice Guidelines and High-Quality Systematic Reviews of Evidence


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 or  Committee rosters follow.



Christine Stencel, Senior Media Relations Officer

Luwam Yeibio, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail


Additional resources:

Report Brief for Practice Guidelines

Report Brief for Systematic Reviews


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  Additional information is available at Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).


#       #       #



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



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.,


Associate Professor of Medicine in


School of Medicine

University of California

San Francisco

Jerry Avorn, M.D.

Professor of Medicine

Harvard Medical School, and


Division of Pharmacoepidemiology 

and Pharmaconomics

Brigham and Women’s Hospital Boston


Robert S. Galvin, M.D.


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.


Evidence-Based Practice Center

Tufts Medical Center



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



John Santa, M.D., M.P.H.


Consumer Reports Health Ratings   


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



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  


University of Pennsylvania



Marita G. Titler, Ph.D., R.N.

Associate Dean

Office of Practice and Clinical   


School of Nursing

University of Michigan

Ann Arbor




Robin Graham, Ph.D., M.P.H.

Study Director




Board on Health Care Services


Committee on Standards for Systematic Review of Comparative Effectiveness Research



Alfred O. Berg, M.D., M.P.H. (chair)


Department of Family Medicine

University of Washington School of Medicine



Sally C. Mortom, Ph.D. (vice chair)

Professor and Chair

Department of Biostatistics

Graduate School of Public Health

University of Pittsburgh



Jesse Berlin, Ph.D.

Vice President of Epidemiology

Johnson & Johnson Pharmaceutical Research and


Titusville, N.J.


Giselle Corbie-Smith, M.D., M.Sc.


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


Center for Clinical Trials and U.S. Cochrane Center

Johns Hopkins Bloomberg School of Public Health



Jeremy Grimshaw, M.B.Ch.B., Ph.D.

Senior Scientist

Clinical Epidemiology Program

Ottawa Hospital Research Center, and


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


Oregon Evidence-Based Practice Center

Oregon Health and Science University



Vincent E. Kerr, M.D.


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


Department of Psychiatry and Psychology

Mayo Clinic

Rochester, Minn.


Christopher Schmid, Ph.D.


Biostatistics Research Center

Institute for Clinical Research and Health Policy Studies, and

Professor of Medicine

Tufts Medical Center

Tufts University



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.



Jill Eden

Study Director