Optimizing the design of invasive placebo interventions in randomized controlled trials.,British Journal of Surgery

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Optimizing the design of invasive placebo interventions in randomized controlled trials.
British Journal of Surgery ( IF 8.6 ) Pub Date : 2020-03-18 , DOI: 10.1002/bjs.11509
S Cousins _{1,

2} , N S Blencowe _{1,

2,

3} , C Tsang _{1,

2} , K Chalmers _{1,

2} , A Mardanpour _{1,

2} , A J Carr ₄ , M K Campbell ₅ , J A Cook _{4,

6} , D J Beard _{4,

6} , J M Blazeby _{1,

2,

3}

Affiliation

Placebo‐controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In‐depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs.

中文翻译：

优化随机对照试验中侵入性安慰剂干预的设计。

安慰剂对照试验在评估医疗干预措施方面发挥着重要作用。然而，对于侵入性干预措施（包括手术）的设计和实施，它们可能具有挑战性。需要深入了解治疗干预的组成部分，以确定应该和不应该作为安慰剂的一部分提供什么。还需要评估患者的风险和确保安慰剂有效模拟治疗的策略。迄今为止，尚无针对侵入性安慰剂干预设计的指南。本研究旨在开发一个框架，以优化 RCT 中侵入性安慰剂干预的设计和实施。

更新日期：2020-03-18

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