BMJ 2003;326:41-44 ( 4 January )

Education and debate

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative

Patrick M Bossuyt, professor of clinical epidemiology, a Johannes B Reitsma, clinical epidemiologist, a David E Bruns, editor, b Constantine A Gatsonis, professor of medical science (biostatistics) and applied mathematics, c Paul P Glasziou, professor of evidence based practice, d Les M Irwig, professor of epidemiology, e Jeroen G Lijmer, clinical epidemiologist, a David Moher, director, f Drummond Rennie, deputy editor, g Henrica C W de Vet, professor of epidemiology, h for the STARD steering group.

a Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, Netherlands, b Clinical Chemistry, University of Virginia, Charlottesville, VA 22903-0757, USA, c Center for Statistical Sciences, Brown University, Providence, RI 02912, USA, d School of Population Health, University of Queensland, Brisbane, Queensland 4006, Australia, e Department of Public Health and Community Medicine, University of Sydney, Sydney, NSW 2006, Australia, f Thomas C Chalmer's Center for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8LI, Canada, g JAMA, 515 N State St, Chicago, IL 60610, USA, h Institute for Research in Extramural Medicine, VU University Medical Center, 1081 BT Amsterdam, Netherlands

Correspondence to: P Bossuyt stard{at}amc.uva.nl

Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in a study, and to evaluate a study's 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 about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25 item checklist, by using evidence, whenever available. A prototype of a 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 and the reference standard, or both.
Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the STARD checklist and 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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Rapid Responses:

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Climbing the Health Outcome Mountain: are clinical microbiologists in the diagnostic team?
Giuseppe Giocoli
bmj.com, 6 Jan 2003 [Full text]
Would the incorporation of a sample size item be appropriate in the STARD checklist?
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bmj.com, 12 Jan 2003 [Full text]
Re: Would the incorporation of a sample size item be appropriate in the STARD checklist?
Patrick M Bossuyt
bmj.com, 14 Jan 2003 [Full text]
Accuracy should be evaluated in relation to patient outcomes and the population context
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bmj.com, 15 Jan 2003 [Full text]
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