Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research

Conditions
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Outcome Assessments (Health Care), Comprehension, Language

Intervention / Treatment
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* Other: Questionnaire of understanding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Every volunteers included in a study in a french clinical research center Ability to read and write in French Exclusion Criteria: Refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research participants<br>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. | Other: Questionnaire of understanding<br>* The study involved 12 clinical trials conducted in the Clinical Research Center Paris Est. Twenty participants per trial were offered to answer the Qualité de Compréhension des Formulaires d'information et de consentement questionnaire (QCFic) at the inclusion visit after receiving the information by the investigator and signed or refused to sign the form of consent. Participants filled out the questionnaire in an isolated location, with no possibility of re-reading the information contained in the consent form. The questionnaire was immediately retrieved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the overall comprehension score and the readability index of Flesch |  | Immediate evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Correlation between the overall comprehension score and the type of study |  | Immediate evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Language tests, Outcome Assessments (Health Care), Volunteers, Informed consent, Comprehension