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

Not Applicable

Completed

• Conditions: Comprehension
• Interventions: Other: readability improvement and good practice redaction; Other: Control

• Registration Number: NCT00908557
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2013-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	readability improvement and good practice redaction	Patients receiving an information and consent form that has been modified using the LISYCOM methods.
2	Control	Patients receiving a standard information and consent form.

Primary Outcome Measures

Name	Time	Method
Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.	24 hours

Secondary Outcome Measures

Name	Time	Method
Sub-scores in part B (subjective comprehension) of questionnaire of comprehension.	24 hours
Score of the QECIEMc	1 year
Total score in the QECIEM 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
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

Trial Locations

Locations (1)

Clinical Research Center, University Hospital Grenoble; 🇫🇷 Grenoble, France