TherapeuticMisconceptionStudy FINAL 2014-2016

Therapeutic Misconception (TM) is recognized as a major limitation on valid consent to clinical trials.TM occurs when a research subject fails to grasp the distinction between the imperatives of clinical trials and of ordinary treatment and inaccurately attributes therapeutic intent to research procedures. We conducted a simulated clinical trial on a new method for reducing TM involving two groups. The control group receives a narrated slide show that mimics an ordinary consent process. The experimental group receives the same slide show, but it is preceded by a detailed explanation of the design of clinical trials. The following data file, in Excel format, was used in our analyses for the project.治疗性误解（Therapeutic Misconception，TM）被公认为损害临床试验知情同意有效性的主要局限。当研究受试者无法厘清临床试验与常规诊疗的操作准则差异，并错误地将研究程序归因于治疗性意图时，便会产生治疗性误解。本研究针对一种可降低治疗性误解的新方法开展了模拟临床试验，设置两组对照：对照组观看一段模拟常规知情同意流程的旁白式幻灯片演示；实验组观看完全相同的幻灯片，但在演示前增加了关于临床试验设计的详细讲解。本研究的数据分析环节使用了如下Excel格式的数据文件。