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Electronic Trial Banks: A Complementary Method for Reporting Randomized Trials

Address correspondence and reprint requests to Dr Sim: Department of Medicine, and Medical Information Sciences, University of California, San Francisco, 400 Parnassus Avenue, Room A-405, San Francisco, CA 94143-0320; telephone: (415) 502-1954; fax: (415) 476-7964; e-mail: <sim{at}medicine.ucsf edu)

Douglas K. Owens, MD, MS

Address correspondence and reprint requests to Dr Sim: Department of Medicine, and Medical Information Sciences, University of California, San Francisco, 400 Parnassus Avenue, Room A-405, San Francisco, CA 94143-0320; telephone: (415) 502-1954; fax: (415) 476-7964; e-mail: <sim{at}medicine.ucsf edu)

Philip W. Lavori, PhD

Address correspondence and reprint requests to Dr Sim: Department of Medicine, and Medical Information Sciences, University of California, San Francisco, 400 Parnassus Avenue, Room A-405, San Francisco, CA 94143-0320; telephone: (415) 502-1954; fax: (415) 476-7964; e-mail: <sim{at}medicine.ucsf edu)

Glenn D. Rennels, MD, PhD

Address correspondence and reprint requests to Dr Sim: Department of Medicine, and Medical Information Sciences, University of California, San Francisco, 400 Parnassus Avenue, Room A-405, San Francisco, CA 94143-0320; telephone: (415) 502-1954; fax: (415) 476-7964; e-mail: <sim{at}medicine.ucsf edu)

Background. Randomized clinical trial (RCT) results are often difficult to find, interpret, or apply to clinical care. The authors propose that RCTs be reported into electronic knowledge bases—trial banks—in addition to being reported in text. What information should these trial-bank reports contain? Methods. Using the competency decomposition method, the authors specified the ideal trial-bank contents as the information necessary and sufficient for completing the task of systematic reviewing. Results. They decomposed the systematic reviewing task into four top-level tasks and 62 subtasks. 162 types of trial information were necessary and sufficient for completing these subtasks. These items relate to a trial's design, execution, administration, and results. Conclusion. Trial-bank publishing of these 162 items would capture into computer-understandable form all the trial information needed for critically appraising and synthesizing trial results. Decision-support systems that access shared, up-to-date trial banks could help clinicians manage, synthesize, and apply RCT evidence more effectively. Key words: electronic publishing; knowledge bases; clinical trials; meta-analysis. (Med Decis Making 2000;20:440-450)

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