Durand-Zaleski I S, Alberti C, Durieux P, Duval X, Gottot S, Ravaud Ph, Gainotti S, Vincent-Genod C, Moreau D, Amiel P
AP-HP, Henri Mondor Hospital, Public Health, Créteil, France.
J Med Ethics. 2008 Sep;34(9):e16. doi: 10.1136/jme.2007.023473.
Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.
To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies).
The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire.
A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69-97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.
The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.
临床研究中的知情同意在全球都是强制性的。患者受试者和研究者都需要理解并接受研究与治疗之间的区别。
记录从各种多中心试验（母研究）招募的患者受试者或家长代理人群体中治疗性误解的程度，并确定与之相关的因素。
该研究包括两个阶段：开发一份评估知情同意质量的问卷，以及基于这份问卷对患者受试者进行调查。
总共联系了303名患者受试者或家长代理人，分析了279份问卷。中位年龄为49.5岁，性别比为1，61%的受访者职业活跃。对知情同意的口头或书面沟通的总体记忆良好（69%-97%），对该过程的满意度约为70%。70%的受访者存在治疗性误解，他们期望得到更好的治疗，而忽略了随机分组和治疗比较的后果。这与疾病的急性程度和严重程度呈正相关。
作者建议，作为针对患者和研究者的一种教育工具，应在同意书中特别提及治疗性误解的风险。
