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STARD Initiative |
1 Department of Clinical Epidemiology and Biostatistics, Academic Medical CenterUniversity of Amsterdam, 1100 DE Amsterdam, The Netherlands.
2 Department of Pathology, University of Virginia, Charlottesville, VA 22903.
3 Clinical Chemistry, Washington, DC 20037.
4 Centre for Statistical Sciences, Brown University, Providence, RI 02912.
5 Centre for General Practice, University of Queensland, Herston QLD 4006, Australia.
6 Department of Public Health & Community Medicine, University of Sydney, Sydney NSW 2006, Australia.
7 Chalmers Research Group, Ottowa, Ontario, K1N 6M4 Canada.
8 Institute for Health Policy Studies, University of California, San Francisco, San Francisco, CA 94118.
9 Journal of the American Medical Association, Chicago, IL 60610.
10 Institute for Research in Extramural Medicine, Free University, 1081 BT Amsterdam, The Netherlands.
aAddress correspondence to this author at: Department of Clinical Epidemiology and Biostatistics, Academic Medical CenterUniversity of Amsterdam, PO Box 22700, 1100 DE Amsterdam, The Netherlands. Fax 31-20-6912683; e-mail Stard{at}amc.uva.nl.
Background: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.
Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability.
Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.
Results: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both.
Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.
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