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

TLDR

Diagnostic accuracy studies are prone to bias and may not generalize, so detailed reporting of design and conduct is essential for assessing trustworthiness and applicability. The STARD statement was created to enhance the completeness and transparency of diagnostic accuracy study reports, and this paper presents the 2015 explanation and elaboration document. STARD provides a checklist of essential items and, in this document, the authors offer commented examples that explain each of the 30 items and outline what authors should include to produce informative reports. STARD was recently updated, and the updated checklist and related materials are freely available online.

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.