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.

治疗误解（Therapeutic Misconception，TM）被公认为临床试验有效知情同意的主要限制因素。当研究受试者无法区分临床试验与常规诊疗的行动要求，并错误地将研究操作归因于治疗意图时，便会出现治疗误解。本研究针对一种可降低治疗误解的新方法设置两组开展模拟临床试验：对照组采用与常规知情同意流程一致的带讲解幻灯片演示；实验组则使用完全相同的幻灯片演示，但在演示前会先针对临床试验的设计进行详细讲解。本项目数据分析所用的以下数据文件为Excel格式。