Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 主要终点
- Correlation between the overall comprehension score and the readability index of Flesch
研究概览
简要总结
Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent. The willingness to inform patients of all risks and constraints related to research may be in contradiction with the need to write informative and concise documents that are understandable to research participants. As a result, consent forms are long, contain a lot of information and are complicated to understand.
The objective of this study is to evaluate the impact of the readability of the information and consent forms on the understanding of the information received by participants in clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Every volunteers included in a study in a french clinical research center
- •Ability to read and write in French
排除标准
- •Refusal of participation
研究组 & 干预措施
Research participants
Each participant of a clinical trial completed the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) about its understanding of the information received. This questionnaire was retrieved immediately on the day of consent, with no possibility of referring to the content of information letter.
干预措施: Questionnaire of understanding (Other)
结局指标
主要结局
Correlation between the overall comprehension score and the readability index of Flesch
时间窗: Immediate evaluation
次要结局
- Correlation between the overall comprehension score and the type of study(Immediate evaluation)
- Correlation between the overall comprehension score and the level of education(Immediate evaluation)
- Correlation between the overall comprehension score and the status of volunteer(Immediate evaluation)
研究者
Joe Elie Salem
MD, PhD
Groupe Hospitalier Pitie-Salpetriere