Multicenter RCT to Assess the Impact of Improvements in Lexico-syntactic Readability and Good Practice in Writing on the Comprehension of Written Information Given to Patients Participating in Clinical Trials.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.
研究概览
简要总结
The principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in writing the Information and Consent Form (ICF) given to patients participating in clinical trials, increases their understanding of the information compared to conventional written information, in real (not simulated) conditions.
详细描述
The quality of written information given to people participating in clinical trials is essential as by law all volunteers have to be informed of a certain number of key elements. Those elements that are necessary to understanding and making a decision as to whether to participate in the trial are presented to the volunteer in the information and consent document (ICD).
Many terms used in the ICD are of necessity medical terms and sometimes difficult to understand for the person who may participate in the study.
Several factors are involved when a reader receives a text, and one of the difficulties of intelligibility can be the lexico-syntactic readability.
The lexico-syntactic readability is the only element of intelligibility that can be readily quantified, using the Flesch-Kincaid index. It is also an element that can be very easily modified without changing the sense of the information.
In the QuIP-3 study, which we performed in 2003, it appeared that the lexico-syntactic readability of ICF is very low, lower than that of texts used in university level classics examinations. Furthermore, there is no correlation between the density of information and readability (QuIP-5 study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject considered suitable to participate in one of the clinical trials selected for the LISYCOM study
- •Age > 18 years
排除标准
- •Illiteracy or inability to read French
- •Neurological deficiency making reading impossible (attention disorders, aphasy, etc)
- •Refusal to participate
研究组 & 干预措施
1
Patients receiving an information and consent form that has been modified using the LISYCOM methods.
干预措施: readability improvement and good practice redaction (Other)
2
Patients receiving a standard information and consent form.
干预措施: Control (Other)
结局指标
主要结局
Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.
时间窗: 24 hours
次要结局
- Score of the QECIEMc(1 year)
- Sub-scores in part B (subjective comprehension) of questionnaire of comprehension.(24 hours)
- Number of refusals to sign informed consent form for the proposed trial.(end of the study or end of Lisycom)
- Total score in the QECIEM questionnaire of comprehension.(24 hours)
- Adhesion to proposed clinical trial protocols(end of the study or end of Lisycom)
- Impact of complementary oral information on the QECIEM scores(24 hours)
- Subjective evaluation of readability by the investigator(begin of the study or begin of Lisycom)
研究者
AdministrateurCIC
Pr Jean-Luc CRACOWSKI
University Hospital, Grenoble