Cotton Peter, Pauls Qi, Wood April, Durkalski-Mauldin Valerie
Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, United States.
Department of Public Health Science, Medical University of South Carolina, Charleston, South Carolina, United States.
Endosc Int Open. 2019 Nov;7(11):E1322-E1326. doi: 10.1055/a-0900-3789. Epub 2019 Oct 22.
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. 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. 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. 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.
本研究旨在展示在“Oddi括约肌功能障碍的预测因素与干预评估（EPISOD）研究”中所使用的技术以及设盲的有效性。这是一项大型假手术对照试验，旨在评估内镜下括约肌切开术治疗疑似Oddi括约肌功能障碍患者的疗效。我们描述了旨在确保受试者、护理人员以及评估结果的人员对治疗分配不知情的方法，并使用邦氏设盲指数（BI）作为潜在破盲指标，系统地评估每个治疗组中受试者设盲程序的成功情况。设盲程序被证明是可接受的，且各研究点的研究团队均严格遵守。BI表明，无论治疗分配如何，受试者都存在“一厢情愿”的情况，即便他们对自己的判断很有信心。我们得出结论，在假手术对照干预研究中设计并维持一种治疗分配设盲系统是可行的。应收集治疗猜测以及对猜测的信心，以检验设盲程序的成功与否。EPISOD研究为未来内镜领域的假手术对照试验提供了蓝本。
