Quality of reporting of test accuracy studies in reproductive medicine: impact of the Standards for Reporting of Diagnostic Accuracy (STARD) initiative.

OBJECTIVE

To evaluate the extent to which test accuracy studies published in two leading reproductive medicine journals in the years 1999 and 2004 adhered to the Standards for Reporting of Diagnostic Accuracy (STARD) initiative parameters, and to explore whether the introduction of the STARD statement has led to an improved quality of reporting.

DESIGN

Structured literature search. Articles that reported on the diagnostic performance of a test in comparison with a reference standard were eligible for inclusion. For each article we scored how well the 25 items of the STARD checklist were reported. These items deal with the study question, study participants, study design, test methods, reference standard, statistical methods, reporting of results, and conclusions. We calculated the total number of reported STARD items per article, summary scores for each STARD item, and the average number of reported STARD items per publication year.

SETTING

Not applicable.

PATIENT(S): Not applicable.

INTERVENTION(S): Not applicable.

MAIN OUTCOME MEASURE(S): Quality of reporting.

RESULT(S): We found 24 studies reporting on test accuracy in reproductive medicine in 1999 and 27 studies in 2004. The mean number of reported STARD items for articles published in 1999 was 12.1 +/- 3.3 (range 6.5-20) and 12.4 +/- 3.2 (range 7-17.5) in 2004, after publication of the STARD statement. Overall, less than half of the studies reported adequately on 50% or more of the STARD items. The reporting of individual items showed a wide variation. There was no significant improvement in mean number of reported items for the articles published after the introduction of the STARD statement.

CONCLUSION(S): Authors of test accuracy studies in the two leading fertility journals poorly report the design, conduct, methodology, and statistical analysis of their study. Strict adherence to the STARD guidelines should be encouraged.