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BMJ Open. 2016 Nov 14;6(11):e012799. doi: 10.1136/bmjopen-2016-012799.

STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration.

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Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Department of Pediatrics, INSERM UMR 1153, Necker Hospital, AP-HP, Paris Descartes University, Paris, France.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island, USA.
Cochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, The Netherlands.
Screening and Diagnostic Test Evaluation Program, School of Public Health, University of Sydney, Sydney, New South Wales, Australia.
Department of Radiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Radiology Editorial Office, Boston, Massachusetts, USA.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, The Netherlands.
Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.


Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports.


Diagnostic accuracy; Medical publishing; Peer review; Reporting quality; Research waste; Sensitivity and specificity

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