Maintaining the blind in sham controlled interventional trials: lessons from the EPISOD study
Maintaining the blind in sham controlled interventional trials: lessons from the EPISOD study
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在假对照干预试验中保持盲法：EPISOD 研究的教训
DOI：
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发表时间：
2019
影响因子：
2.6
通讯作者：
V. Durkalski
中科院分区：
文献类型：
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作者：
P. Cotton;Qi Pauls;April L Wood;V. Durkalski
摘要目的和研究目的本研究旨在证明EPISOD研究（评价Oddi括约肌功能障碍的预测因素和干预措施）中使用的技术和盲法的有效性。 这是一项大型假对照试验，旨在评价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。患者和方法我们描述的方法，旨在确保受试者，护理人员和那些评估结果是盲目的治疗分配和系统地评估受试者盲法程序的成功使用Bang的盲法指数（BI）为每个治疗组作为一个潜在的揭盲指标。 结果设盲程序被证明是可接受的，并由每个研究中心的研究团队遵守。 BI表明受试者的“一厢情愿”，无论治疗分配如何，即使他们对自己的观点充满信心。结论我们认为，在一项假对照干预性研究中，设计和维护一个治疗分配设盲系统是可能的。 应收集治疗猜测加猜测置信度，以检查设盲程序的成功性。EPISOD研究为未来内镜检查的假对照试验提供了蓝图。
Abstract 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.
内窥镜括约肌切开术对可疑的ODDI功能障碍括约肌对胆囊切除术后疼痛相关的残疾的括约肌的影响：EPIPOD随机临床试验。
影响因子：
120.7
作者：
Cotton, Peter B.;Durkalski, Valerie;Romagnuolo, Joseph;Pauls, Qi;Fogel, Evan;Tarnasky, Paul;Aliperti, Giuseppe;Freeman, Martin;Kozarek, Richard;Jamidar, Priya;Wilcox, Mel;Serrano, Jose;Brawman-Mintzer, Olga;Elta, Grace;Mauldin, Patrick;Thornhill, Andre;Hawes, Robert;Wood-Williams, April;Orrell, Kyle;Drossman, Douglas;Robuck, Patricia
通讯作者：
Robuck, Patricia