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STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration
  1. Jérémie F Cohen1,2,
  2. Daniël A Korevaar1,
  3. Douglas G Altman3,
  4. David E Bruns4,
  5. Constantine A Gatsonis5,
  6. Lotty Hooft6,
  7. Les Irwig7,
  8. Deborah Levine8,9,
  9. Johannes B Reitsma10,
  10. Henrica C W de Vet11,
  11. Patrick M M Bossuyt1
  1. 1Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
  2. 2Department of Pediatrics, INSERM UMR 1153, Necker Hospital, AP-HP, Paris Descartes University, Paris, France
  3. 3Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  4. 4Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia, USA
  5. 5Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island, USA
  6. 6Cochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, The Netherlands
  7. 7Screening and Diagnostic Test Evaluation Program, School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  8. 8Department of Radiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
  9. 9Radiology Editorial Office, Boston, Massachusetts, USA
  10. 10Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, The Netherlands
  11. 11Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands
  1. Correspondence to Professor Patrick M M Bossuyt; p.m.bossuyt{at}amc.uva.nl

Abstract

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 http://www.equator-network.org/reporting-guidelines/stard. 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.

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

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • JFC and DAK contributed equally to this manuscript and share first authorship.

  • Contributors JFC, DAK and PMMB are responsible for drafting of manuscript. DGA, DEB, CAG, LH, LI, DL, JBR and HCWdV are responsible for critical revision of manuscript.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

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