Toward a checklist for reporting of studies of diagnostic accuracy of medical tests

Background: "Diagnostic accuracy" refers to the ability of medical tests to provide accurate information about diagnosis, prognosis, risk of disease, and other clinical issues. Published reports on diagnostic accuracy of medi cal tests frequently fail to adhere to minimal clinical epidemiological sta ndards, and such failures lead to overly optimistic assessments of evaluate d tests. Our aim was to enumerate key items for inclusion in published repo rts on diagnostic accuracy, with a related aim of making the reports more u seful for systematic reviews. Methods: We examined published reports on shortcomings of studies of diagno stic accuracy. We prepared an initial draft of a checklist to address commo n errors and presented it at a meeting of editors. After incorporation of c omments from editors, we published a revised version in Clinical Chemistry in 1997 for comment from readers. One of us (E.M.) additionally circulated copies of the draft to methodologists and others interested in Evidence-Bas ed Medicine. We updated the checklist with input from these sources. Results: The updated document lists items for inclusion in the title, abstr act, methods, results, and discussion sections of published papers. Dependi ng on the nature of the study, the total number of items for a single paper is similar to 40. We invite comments on this document, which is freely ava ilable at Clinical Chemistry Online, where it can be accessed readily from the Table of Contents for the July 2000 issue at www.clinchem.org/content/v ol46/ issue7/. Comments (eLetters) can be posted there for general reading. Conclusions: The suggested revisions incorporated in this report appear use ful to ensure inclusion of additional information that can allow assessment of the validity of the conclusions and the applicability of the study in o ther settings. The list can be useful in formulating guidelines and a check list, which will require testing by authors and study of their effect on pu blished studies of diagnostic accuracy. (C) 2000 American Association for C linical Chemistry.