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Conducting randomized, controlled trials. Experience with the dysfunctional uterine bleeding intervention trial.
S J Rolnick1, S K Flores, S E Fowler
1HealthPartners Research Foundation, 8100 34th Avenue South, P.O. Box 1524, Minneapolis, MN 55440-1524, USA. cheri.j.rolnick@healthpartners.com
The Journal of Reproductive Medicine
|February 24, 2001
Summary
Recruiting for randomized controlled trials (RCTs) comparing hysterectomy, endometrial ablation, and medical management for dysfunctional uterine bleeding proved difficult. Patient and provider acceptance is crucial for successful clinical trial research.
Area of Science:
- Gynecology
- Clinical Trials
- Medical Research
Background:
- Dysfunctional uterine bleeding (DUB) affects many women.
- Hysterectomy is a standard treatment, but alternatives are sought.
- Therapeutic options for DUB include hysterectomy, endometrial ablation, and medical management.
Purpose of the Study:
- To evaluate therapeutic alternatives to hysterectomy for DUB using a randomized controlled trial (RCT).
- To examine challenges in recruiting participants for comparative treatment studies in gynecology.
Main Methods:
- Initial design: Randomized controlled trial (RCT) with three arms (hysterectomy, endometrial ablation, medical management).
- Targeted recruitment: 375 women.
- Amended design: Elective treatment cohort with a randomization component due to recruitment issues.
Main Results:
- Initial recruitment was very low (5 women in 6 months) due to patient and provider discomfort with randomization.
- Following protocol amendment, recruitment improved significantly (37 women in 4 months).
Conclusions:
- Patient and provider acceptance is critical for the success of clinical trials.
- Randomized controlled trials (RCTs) may not always be the most suitable design for comparing treatments in clinical practice.
- Nonrandomized designs can be appropriate alternatives for certain clinical research questions.