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21 June 2005 | Volume 142 Issue 12 Part 2 | Pages 1048-1055
Diagnostic tests are critical components of effective health care. They help determine treatments that are most beneficial for a given patient. Their assessment is a complex process that includes such challenges as a dearth of studies that evaluate clinical outcomes and lack of data on use of the test in realistic clinical settings. The methodologic quality of studies of diagnostic tests also lags behind the qual ity of studies of therapeutic interventions. Statistical methods to combine diagnostic accuracy data are more complex and not as well developed, leading to difficulties in the interpretation of results. The Agency for Healthcare Research and Quality Technology Assessment Program has adopted a 6-level framework for evaluating diagnostic technologies. The model emphasizes the need for systematic reviews of diagnostic test studies to go beyond the assessment of technical feasibility and accuracy to examine the impact of the test on health outcomes. In this paper, we use examples from 3 Evidence-based Practice Center reports to illustrate 3 challenges reviewers may face when reviewing diagnostic test literature: finding relevant studies, assessing methodologic quality of diagnostic accuracy studies, and synthesizing studies that evaluate tests in different patient populations or use different outcomes.
Author and Article Information
From Tufts-New England Medical Center Evidence-based Practice Center, Tufts-New England Medical Center, Boston, Massachusetts; Agency for Healthcare Research and Quality, Rockville, Maryland; and Blue Cross and Blue Shield Association Technology Evaluation Center, Chicago, Illinois.
Grant Support: In part by grant R01 HS13328 from the Agency for Healthcare Research and Quality (Christopher Schmid, Joseph Lau).
Potential Financial Conflicts of Interest: Employment: N. Aronson (Blue Cross and Blue Shield Association), D.J. Samson (Blue Cross and Blue Shield Association), C.R. Flamm (Blue Cross and Blue Shield Association). Authors of this paper have received funding for Evidence-based Practice Center reports.
Corresponding Author: Joseph Lau, MD, Tufts-New England Medical Center Evidence-based Practice Center, Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111.
Current Author Addresses: Drs. Tatsioni, Schmid, and Lau: Tufts-New England Medical Center Evidence-based Practice Center, Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111.
Dr. Zarin: National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894.
Dr. Aronson, Mr. Samson, and Dr. Flamm: Blue Cross and Blue Shield Association, Technology Evaluation Center, 225 North Michigan Avenue, Chicago, IL 60601-7680. 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 of Diagnostic Technologies
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