Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.
Mov Disord. 2012 Sep 15;27(11):1461-5. doi: 10.1002/mds.25155. Epub 2012 Aug 23.
Sham surgery controls are increasingly used in neurosurgical clinical trials in Parkinson's disease (PD) but remain controversial. We interviewed participants of such trials, specifically examining their understanding and attitudes regarding sham surgery.
We conducted semistructured qualitative interviews with participants of 3 sham surgery-controlled trials for PD, focusing on their understanding of sham design, their reactions to it, its impact on decision making, and their understanding of posttrial availability of the experimental intervention and its impact on decisions to participate.
All subjects (n = 90) understood the 2-arm design; most (86%) described the procedural differences between the arms accurately. Ninety-two percent referred to scientific or regulatory reasons as rationales for the sham control, with 62% specifically referring to the placebo effect. Ninety-one percent said posttrial availability of the experimental intervention had a strong (48%) or some (43%) influence on their decision to participate, but only 68% understood the conditions for posttrial availability.
Most subjects in sham surgery-controlled PD trials comprehend the sham surgery design and its rationale. Although there is room for improvement, most subjects of sham surgery trials appear to be adequately informed.
假手术对照在帕金森病（PD）的神经外科临床试验中越来越多地被采用，但仍存在争议。我们对这些试验的参与者进行了访谈，专门研究了他们对假手术的理解和态度。
我们对 3 项假手术对照 PD 临床试验的参与者进行了半结构式定性访谈，重点关注他们对假手术设计的理解、对其的反应、对决策的影响以及对试验后获得实验干预措施的理解及其对参与决策的影响。
所有受试者（n=90）均理解 2 臂设计；大多数（86%）准确描述了手臂之间的程序差异。92%的人将科学或监管原因作为假手术对照的理由，其中 62%特别提到了安慰剂效应。91%的人表示试验后获得实验干预措施对他们的参与决定有很大（48%）或有些（43%）影响，但只有 68%的人理解试验后获得干预措施的条件。
假手术对照 PD 试验的大多数受试者都理解假手术设计及其原理。尽管还有改进的空间，但假手术试验的大多数受试者似乎都得到了充分的告知。
