Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy.
BACKGROUND
To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors.


OBJECTIVE
To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its 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 on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical 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, the reference standard or both.


CONCLUSIONS
Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.
Bossuyt
Patrick M
PM
Department of Clinical Epidemiology and Biostatistics, Academic Medical Center--University of Amsterdam, 1100 DE Amsterdam, The Netherlands. Stard@amc.uva.nl
Reitsma
Johannes B
JB
Bruns
David E
DE
Gatsonis
Constantine A
CA
Glasziou
Paul P
PP
Irwig
Les M
LM
Lijmer
Jeroen G
JG
Moher
David
D
Rennie
Drummond
D
de Vet
Henrica C W
HC
D000465:Algorithms; D015982:Bias; D002986:Clinical Trials as Topic / Q000592:standards; D019937:Diagnostic Techniques and Procedures / Q000592:standards; D017408:Guidelines as Topic; D011643:Publishing / Q000592:standards; D012107:Research Design / Q000592:standards