Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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). It seems to be necessary to assess the understanding of those participating in clinical trials in terms of logical and cognitive intelligibility (representativeness and interpretability of the information and consent forms). Indeed, a text may be unreadable according to the Flesch score, in lexico-syntactic terms, but perfectly understood and interpreted. As no questionnaire had been validated in French, we validated the  Questionnaire d'Evaluation de la Compréhension de l'Information Ecrite par les Malades or QECIEM  (Questionnaire measuring patient comprehension of written information) (QuIP-4). This questionnaire can be used to measure both objective and subjective general understanding by a patient to be included in a therapeutic study, irrespective of the pathology.

Official Title
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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.

Conditions
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Comprehension

Intervention / Treatment
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* Other: readability improvement and good practice redaction
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject considered suitable to participate in one of the clinical trials selected for the LISYCOM study Age > 18 years Exclusion Criteria: Illiteracy or inability to read French Neurological deficiency making reading impossible (attention disorders, aphasy, etc) Refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving an information and consent form that has been modified using the LISYCOM methods. | Other: readability improvement and good practice redaction<br>* improvement using Flesch readability index and good practice in redaction of informed consent documents.<br>|
| Active Comparator: 2<br>Patients receiving a standard information and consent form. | Other: Control<br>* information based on the classic informed consent document<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score in the QECIEM questionnaire of comprehension. |  | 24 hours | 
| Sub-scores in part B (subjective comprehension) of 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 | 
| Number of refusals to sign informed consent form for the proposed trial. |  | end of the study or end of Lisycom | 
| Score of the QECIEMc |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lexicosyntactic readability improvement, phase II/III trials, ethic, Informed consent