Article Document Academic Article Information Content Entity Continuant Continuant Journal Article Entity Entity Generically Dependent Continuant 2025-05-06T21:59:08 RDF description of Conducting randomized, controlled trials. Experience with the dysfunctional uterine bleeding intervention trial - http://repository.healthpartners.com/individual/document-rn18396 document-rn18396 1 Patient Selection <p>OBJECTIVE: To conduct a randomized, controlled trial (RCT) to examine issues associated with therapeutic alternatives to standard hysterectomy for women with dysfunctional uterine bleeding. STUDY DESIGN: Participants were to be randomly assigned to one of three treatment groups: hysterectomy, endometrial ablation and medical management. Recruitment was targeted at 375 women. RESULTS: Despite multiple recruitment strategies, recruitment was weak, with only five women enrolled after six months. Providers and women screened for eligibility often expressed discomfort with randomization. The protocol was amended to an elective treatment cohort design with a randomization component. Recruitment improved, with 37 women enrolled after four months. CONCLUSION: The success of RCTs may be affected by multiple factors. Acceptance of the protocol by patients and providers is essential. The RCT may present providers with a conflict between the goals of research and of providing optimal individualized care. Thus, RCTs may not always be appropriate for studies designed to examine best treatments in clinical practice, and nonrandomized designs may provide appropriate alternatives in some cases.<p> Patient Satisfaction Uterine Hemorrhage/drug therapy/surgery/*therapy Uterine Diseases *Randomized Controlled Trials 2022-02-21T22:48:57.408-06:00 Hysterectomy Clinical Protocols public Conducting randomized, controlled trials. Experience with the dysfunctional uterine bleeding intervention trial Endometrium/surgery 46 14371 23322 Journal of Reproductive Medicine