Toward complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.
OBJECTIVE
To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, and analysis of such studies. The authors sought to develop guidelines for improving the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers better to assess the validity and generalizability of study results.


METHODS
The Standards for Reporting of Diagnostic Accuracy group steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and to extract potential guidelines for authors and editors. An extensive list of items was prepared. Members of the steering committee then met for 2 days with other researchers, editors, methodologists, statisticians, and members of professional organizations to develop a checklist and a prototypical flowchart to guide authors and editors of studies of diagnostic accuracy.


RESULTS
The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which the group produced an initial list of 75 items. This list was honed to 25 key items by group consensus and on the basis of published research on bias. A prototypical flowchart was developed as a tool for conveying information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference test, or both. Potential users reviewed the conference version of the checklist and flowchart and provided additional suggestions, which were then incorporated.


CONCLUSIONS
Use of these carefully developed, consensus-based guidelines should enable clearer and more complete reporting of studies of diagnostic accuracy, as well as better reader understanding of the validity and generalizability of study results.
Bossuyt
Patrick M
PM
Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, the Netherlands.
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
D015982:Bias; D002986:Clinical Trials as Topic / Q000592:standards; D003226:Congresses as Topic / Q000592:standards; D019937:Diagnostic Techniques and Procedures / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards; D006801:Humans; D011643:Publishing / Q000592:standards; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards*