Roger Chou, MD; Mark Helfand, MD, MPH
An evidence synthesis of a medical intervention should assess the balance of benefits and harms. Investigators performing systematic reviews of harms face challenges in finding data, rating the quality of harms reporting, and synthesizing and displaying data from different sources. Systematic reviews of harms often rely primarily on published clinical trials. Identifying important harms of treatment and quantifyi ng the risk associated with them, however, often require a broader range of data sources, including unpublished trials, observational studies, and unpublished information on published trials submitted to the U.S. Food and Drug Administration. Each source of data has some potential for yielding important information. Criteria for judging the quality of harms assessment and reporting are still in their early stages of development. Investigators conducting systematic reviews of harms should consider empirically validating the criteria they use to judge the validity of studies reporting harms. Synthesizing harms data from different sources requires careful consideration of internal validity, applicability, and sources of heterogeneity. This article highlights examples of approaches to methodologic issues associated with performing systematic reviews of harms from 96 Evidence-based Practice Center evidence reports.
The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.
Chou R, Helfand M. Challenges in Systematic Reviews That Assess Treatment Harms. Ann Intern Med. 2005;142:1090–1099. doi: 10.7326/0003-4819-142-12_Part_2-200506211-00009
Download citation file:
Published: Ann Intern Med. 2005;142(12_Part_2):1090-1099.
Acute Coronary Syndromes, Cardiology, Coronary Heart Disease, Coronary Risk Factors, Emergency Medicine.
Results provided by:
Copyright © 2017 American College of Physicians. All Rights Reserved.
Print ISSN: 0003-4819 | Online ISSN: 1539-3704
Conditions of Use
This PDF is available to Subscribers Only