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Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative

Patrick M. Bossuyt; Johannes B. Reitsma; David E. Bruns; Constantine A. Gatsonis; Paul P. Glasziou; Les M. Irwig; Jeroen G. Lijmer; David Moher; Drummond Rennie; Henrica C.W. de Vet, STARD Group*
[+] Article, Author, and Disclosure Information

From Academic Medical Center, University of Amsterdam, and VU University Medical Center, Amsterdam, the Netherlands; Clinical Chemistry, Washington, D.C.; Brown University, Providence, Rhode Island; University of Queensland Medical School, Herston, and University of Sydney, Sydney, Australia; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; and Journal of the American Medical Association, Chicago, Illinois.

Funding/Support: Financial support to convene the STARD Group was provided in part by the Dutch Health Care Insurance Board, Amstelveen, the Netherlands; the International Federation of Clinical Chemistry, Milano, Italy; the Medical Research Council's Health Services Research Collaboration, Bristol, England; and the Academic Medical Center, Amsterdam, the Netherlands.

Acknowledgment: This initiative to improve the reporting of studies of diagnostic accuracy was supported by a large number of people around the globe who commented on earlier versions.

Requests for Single Reprints: Customer Service, American College of Physicians–American Society of Internal Medicine, 190 N. Independence Mall West, Philadelphia, PA 19106.

Current Author Addresses: Dr. Bossuyt: Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, the Netherlands.

Drs. Reitsma and Lijmer: University of Amsterdam, PO Box 22700, 1100 DE, Amsterdam, the Netherlands.

Dr. Bruns: Clinical Chemistry, 2101 L Street NW, Suite 202, Washington, DC 20037-1558.

Dr. Gatsonis: Center for Statistical Sciences, Brown University, Box G-H, Providence, RI 02912.

Dr. Glasziou: Centre for Evidence-Based Practice, School of Population Health, The University of Queensland Medical School, Herston Road, Herston QLD 4006, Australia.

Dr. Irwig: Department of Public Health and Community Medicine, Room 301, Edward Ford Building A27, University of Sydney, Sydney, NSW 2006, Australia.

Mr. Moher: Thomas C. Chalmers Center for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Room R2226, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada.

Dr. Rennie: Journal of the American Medical Association, 515 North State Street, Chicago, IL 60610.

Dr. de Vet: Institute for Research in Extramural Medicine, VU University Medical Center, Van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands.

Ann Intern Med. 2003;138(1):40-44. doi:10.7326/0003-4819-138-1-200301070-00010
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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 in order to allow readers to assess the potential for bias in the study and to evaluate its generalizability.

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, methodologists and statisticians, and members of professional organizations shortened this list during a 2-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 the clinicians, researchers, reviewers, journals, and the public.

*For members of the STARD Group, see Appendix.


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Prototypical flow diagram of a diagnostic accuracy study.
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