Attitudes Toward Randomized, Controlled Trials in Surgery: Opinions of Gynecologists of the Gruppo Italiano di Studio sull'Endometriosi

In order to assess barriers and the attitudes of gynecologists toward randomized controlled trials (RCT) in surgery for endometriosis, we identified 62 gynecologists affiliated with the Gruppo Italiano di Studio sull'Endometriosi and sent them a questionnaire. A total of 52 (83.9%) gynecologists completed and sent it back to the coordinating center. Most gynecologists strongly agreed or agreed that RCTs should be the study design of choice for evaluating surgical procedures, but 66% also strongly agree/agree that RCTs are best suited to nonsurgical setting. With regard to the feasibility of RCT in surgery, there was a high level (>50%) of agreement with the statement: RCTs are insufficiently funded; the surgical community gives to RCTs too low priority; patients are unlikely to accept random allocation. A total of 43% agree or strongly agree that there is often consensus on new procedures without the need for RCTs, but 49% disagree or strongly disagree. Considering the statements on methodological problems in conducting RCTs in surgery, the main one was that comparisons of new and standard surgical procedures are often basically flawed because they cannot be performed with equal skill. This analysis indicates that RCTs are perceived as an important choice in the development of surgical treatments. However lack of funding, the impression that patients are unlikely to accept randomization, and the idea that comparison of new and old surgical procedures is flawed by the lack of skill in new procedures are important barriers to RCT in this field.