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21 June 2005 | Volume 142 Issue 12 Part 2 | Pages 1090-1099
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and quantifyi ng the risk associated with them, however, often require a broader range of data sources, including unpublished trials, observational studies, and unpublished information on published trials submitted to the U.S. Food and Drug Administration.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.
Author and Article Information
From the Oregon Evidence-based Practice Center, Oregon Health & Science University, and Portland Veterans Affairs Medical Center, Portland, Oregon.
Acknowledgments: The authors thank Michele Freeman for her help in abstracting data.
Grant Support: This study was conducted by the Oregon Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (contract 290-02-0024, task order 1).
Potential Financial Conflicts of Interest: Authors of this paper have received funding for Evidence-based Practice Center reports.
Requests for Single Reprints: Roger Chou, MD, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR; e-mail, chour{at}ohsu.edu.
Current Author Addresses: Drs. Chou and Helfand: Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239. CHALLENGES OF SUMMARIZING BETTER INFORMATION FOR BETTER HEALTH: THE EVIDENCE-BASED PRACTICE CENTER EXPERIENCE
Mark Helfand, MD, MPH; Sally Morton, PhD; Eliseo Guallar, MD, PhD; and Cynthia Mulrow, MD, MSc, Editors
Challenges in Systematic Reviews That Assess Treatment Harms
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