Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology.
OBJECTIVE
Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references.


METHODS
We performed a hand search of the American Journal of Obstetrics and Gynecology, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria.


RESULTS
Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p < 0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials.


CONCLUSIONS
Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.
Grimes
D A
DA
Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, USA.
Schulz
K F
KF
D001634:Bibliographies as Topic; D004282:Documentation; D005260:Female; D006176:Gynecology; D006801:Humans; D009774:Obstetrics; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data