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The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration

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

From Academic Medical Center and VU University Medical Center, Amsterdam, the Netherlands; Clinical Chemistry, Charlottesville, Virginia; Brown University, Providence, Rhode Island; University of Queensland Medical School, Herston, Australia; University of Sydney, Sydney, Australia; Thomas C. Chalmers Center for Systematic Reviews, Ottawa, Ontario, Canada; and Journal of the American Medical Association, Chicago, Illinois.

Note: The STARD statement is available in several journals, including Annals of Internal Medicine, Clinical Chemistry, Radiology, BMJ, The Lancet, American Journal of Clinical Pathology, Clinical Biochemistry, Clinical Chemistry and Laboratory Medicine, and Journal of Clinical Microbiology.

Requests for Single Reprints: Patrick M. Bossuyt, Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, the Netherlands; e-mail, p.m.bossuyt@amc.uva.nl.

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 USA 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 N. 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):W1-12. doi:10.7326/0003-4819-138-1-200301070-00012-w1
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The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalizability of the results.A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present.This explanatory document aims to facilitate the use, understanding, and dissemination of the checklist. The document contains a clarification of the meaning, rationale, and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability.The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.


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Figure 1.
Example of a flow diagram of a diagnostic accuracy study(55)


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Figure 2.
Distribution on a log scale of the test results according to anti-CCP units for the different groups of patients.
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