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Published White Paper Series Provides Groundwork for Methods Guide To Compare Medical Tests

A set of white papers published in the September 22, 2009, issue of Medical Decision Making will serve as the groundwork for an Agency for Healthcare Research and Quality (AHRQ) Work Group charged with creating a new methods guide to focus on comparisons of diagnostic and prognostic tests for the Effective Health Care (EHC) Program. The new methods guide is scheduled to be released in draft form during the first part of 2010.

Image of x-ray overlayed with a hand holding a grease pencil.The white papers were originally commissioned by AHRQ and presented to researchers from the various Evidence-based Practice Centers by international leaders in the field of systematic reviews. The goal of the papers was to provide EHC Program researchers with state-of-the-art methods for conducting assessments of evidence surrounding medical test technologies and procedures. A planning committee of AHRQ staff and the directors of the 14 Evidence-based Practice Centers coordinated the conference, held in May 2008, to help the Work Group begin addressing the specific methodological needs for this type of comparative effectiveness research.

Originally planned as a single chapter in the current Methods Guide for Effectiveness and Comparative Effectiveness Reviews, the white papers clarified the need for a separate guide with multiple chapters on the subject, stated Mark Helfand, Director of the Oregon Evidence-based Practice Center and leader of the project. Smaller groups of researchers are working on the various chapters of the upcoming guide.

“This is an essential service for patients and clinicians trying to decide between various diagnostic tests, each of which has its own benefits and harms.” Mark Helfand, M.D.

The four white papers cover a broad range of issues related to comparing medical tests. The first, written by Jeroen G. Lijmer, M.D., Ph.D., Mariska Leeflang, Ph.D., and Patrick M.M. Bossuyt, Ph.D., explores proposals for a phased evaluation of medical tests. The second, “Additional Patient Outcomes and Pathways in Evaluations of Testing,” is written by Dr. Bossuyt and Kirsten McCaffery, Ph.D. The third is titled “Using the Principles of Randomized Controlled Trial Design to Guide Test Evaluation” and is written by Sarah J. Lord, M.B., B.S., M.S., Les Irwig, M.B., B.Ch., Ph.D., and Dr. Bossuyt. The fourth paper, by Thomas A. Trikalinos, M.D., Uwe Siebert, M.D., M.P.H., M.Sc., Sc.D., and Joseph Lau, M.D., examines decision-analytic modeling to evaluate benefits and harms of medical tests.

The last set of guidance documents for assessing the many issues related to diagnostic and prognostic tests — including the assessment of technical and diagnostic performance, the therapeutic and outcome impact, and the societal impact of any given medical test — was created in the 1980s. The planning committee believed that it was important to revisit the literature to identify aspects that have changed in this rapidly developing field.

“Assessing and comparing medical tests and testing technology is extremely challenging,” Dr. Helfand said. “But this is an essential service for patients and clinicians trying to decide between various diagnostic tests, each of which has its own benefits and harms.”

The published articles can also be accessed on the EHC Program Web site.