Conducting randomized, controlled trials - Experience with the dysfunctional uterine bleeding intervention trial

OBJECTIVE: To conduct 17 randomized, controlled trial ((RCT) to examine iss ues associated with therapeutic alternatives to standard hysterectomy for w omen with dysfunctional uterine bleeding. STUDY DESIGN: Participants were to be randomly assigned to one of three tre atment groups: hysterectomy, endometrial ablation and medical management. R ecruitment was targeted at 375 women. RESULTS: Despite multiple recruitment strategies, recruitment strategies, r ecruitment was weak, with only five enrolled after six months. Providers an d women screened for eligibility often expressed discomfort with randomizat ion. The protocol was amended to an elective treatment cohort design with a randomized component. Recruitment improved, with 37 women enrolled after f our months. CONCLUSION: The success of RCTs may be affected by multiple factors. Accept ance of the protocol bt patients and providers is essential. The RCT may pr esent providers with a conflict between the goals of research and of provid ing optimal individualized care. Thus, RCTs may not always be appropriate f or studies designed to examine best treatments in clinical practice, and no n-randomized designs may provide appropriate alternative in some cases.