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Maintaining the blind in sham controlled interventional trials: lessons from the EPISOD study

机译：在虚假控制的介入试验中维护盲目：从episod研究中的课程

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Objective and study aims?This study was designed to demonstrate the techniques used and the effectiveness of blinding in the EPISOD study (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction). This was a large sham-controlled trial evaluating the efficacy of endoscopic sphincterotomy treatment for patients with suspected sphincter of Oddi dysfunction. Patients and methods?We describe the methods intended to ensure that the subjects, caregivers and those assessing the outcomes were blinded to the treatment allocation and systematically assess the success of subject blinding procedures using the Bang’s Blinding Index (BI) for each treatment arm as an indicator of potential unblinding. Results?Blinding procedures proved to be acceptable and adhered to by the study team at each site. The BI indicated “wishful thinking” by the subjects regardless of treatment assignment, even when they were confident in their opinions. Conclusion?We conclude that it is possible to design and maintain a system for blinding the treatment allocation in a sham-controlled interventional study. Treatment guess plus confidence in the guess should be collected to examine the success of blinding procedures. The EPISOD study provides a blueprint for future sham-controlled trials in endoscopy.
机译：目的和学习目标？本研究旨在展示所使用的技术和盲目研究中的致盲的有效性（评估Oddi功能障碍的括约肌中的预测因子和干预）。这是一个大型假手术试验，评估内镜晶体化术治疗对疑似括约肌括号括约肌患者的疗效。患者和方法？我们描述了旨在确保受试者，护理人员和评估结果的方法对治疗分配蒙蔽，并系统地评估了使用爆炸的盲目指数（BI）作为每个治疗臂的主体致盲程序的成功潜在未粘连的指标。结果？致盲程序被证明是可以接受的，并由每个网站的研究团队遵守。对于受试者表示，无论治疗任务如何，均表明了“一厢情愿的思维”，即使他们对他们的意见充满信心。结论？我们得出结论，可以设计和维护一个系统，以揭示假控制的介入研究中的治疗分配。应收集治疗猜测加上猜测的信心，以检查盲目程序的成功。 Episod研究为未来的内窥镜检查中的假手术试验提供了蓝图。

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