Department of Family Medicine, Kangwon National University Hospital, 26 Kangwon Daehakro, Chuncheon, Kangwon Province, South Korea.
J Med Ethics. 2012 Feb;38(2):102-6. doi: 10.1136/jme.2010.040972. Epub 2011 Jun 27.
Participants' understanding of clinical trials is important in informed consent. However, little is known about what information participants really want to know.
To demonstrate the existence of a discrepancy between participants' understanding and their desire to know.
The participants in clinical trials at Seoul National University Hospital were surveyed. The survey consisted of 11 statements based on the essential elements of informed consent. The participants gave two responses to each statement on a five-point Likert scale to rate their subjective understanding and desire to know, respectively. Information discrepancy was defined as the difference between these two ratings: if understanding exceeded desire to know for a particular item, it was defined as 'over-informed'; if desire to know exceeded understanding for a particular item, it was defined as 'under-informed'.
Participants reported good understanding of 'voluntariness', 'duration', 'study involves research' and poor understanding of 'confidentiality', 'compensation', 'benefits', 'procedures' and 'risks or discomforts'. For 'risks or discomforts', 'who to contact', 'voluntariness', 'duration' and 'procedures', participants reported high desire to know compared with 'confidentiality', 'purpose', 'study involves research' and 'benefits'. The elements 'study involves research', 'voluntariness', 'duration', 'purpose' and 'who to contact' were over-informed, while 'compensation', 'risks or discomforts', 'procedures', 'confidentiality' and 'benefits' were under-informed. Participants over 50 years of age, those without a college education and those whose participation was less voluntary were relatively less informed about the clinical trials.
An information discrepancy was observed between the participants' understanding and their desire to know. By putting more emphasis on under-informed elements, the quality of informed consent could be improved.
参与者对临床试验的理解在知情同意中很重要。然而，参与者真正想知道什么信息却知之甚少。
展示参与者的理解与其想知道的信息之间存在差异。
对首尔国立大学医院临床试验的参与者进行了调查。该调查由 11 个基于知情同意基本要素的陈述组成。参与者对每个陈述分别在 5 点李克特量表上给出两个反应，以分别评估他们的主观理解和渴望知道的程度。信息差异定义为这两个评分之间的差异：如果特定项目的理解超过了渴望知道的程度，则定义为“过度知情”；如果特定项目的渴望知道程度超过了理解程度，则定义为“知情不足”。
参与者报告对“自愿性”、“持续时间”、“研究涉及研究”有较好的理解，对“保密性”、“补偿”、“收益”、“程序”和“风险或不适”理解较差。对于“风险或不适”、“联系谁”、“自愿性”、“持续时间”和“程序”，与“保密性”、“目的”、“研究涉及研究”和“收益”相比，参与者报告了较高的渴望知道的程度。“研究涉及研究”、“自愿性”、“持续时间”、“目的”和“联系谁”这些元素被过度告知，而“补偿”、“风险或不适”、“程序”、“保密性”和“收益”这些元素则被告知不足。年龄在 50 岁以上、没有大学学历和参与意愿较低的参与者对临床试验的了解相对较少。
观察到参与者的理解与其渴望知道的信息之间存在信息差异。通过更加重视告知不足的元素，可以提高知情同意的质量。
