METHODOLOGY CITATIONS AND THE QUALITY OF RANDOMIZED CONTROLLED TRIALSIN OBSTETRICS AND GYNECOLOGY

OBJECTIVES: Randomized controlled trials offer the best chance for val id treatment comparisons, yet most trials are of poor quality. This ma y reflect a lack of awareness of the requirements for conducting and r eporting this type of research. If so, then citation of methodology re ferences might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quali ty of published trials is related to citation of methodology reference s. STUDY DESIGN: We performed a hand search of the AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, the British Journal of Obstetrics and Gyna ecology, 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 report s of randomized controlled trials and evaluated the adequacy of random ization methods by accepted criteria. RESULTS: Most reports (81.6%) ci ted no methodology text or article. Although lack of any methodology r eference was not significantly related to failure to report an adequat e random method of sequence generation, this was highly related (p < 0 .001) to failure to report adequate allocation concealment. Scanning t he reference list of reports took a mean of 16 seconds and identified most poorly done trials. CONCLUSIONS: Investigators who conduct random ized Controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful a nd often misleading.