Clinical trial NCT00908557: Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comprehension
Keywords: Lexicosyntactic readability improvement
phase II/III trials
ethic
Informed consent
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Research Center of Grenoble
name: Clinical Research Center of Strasbourg
name: Hôpital Necker-Enfants Malades
name: Clinical Research Center of Lyon
name: Clinical Research Center of Bichat, Paris
name: Clinical Research Center of Saint-Etienne
name: Clinical Research Center - biotherapy center of Saint-Louis, Paris
name: Clinical Research Center of Clermont-Ferrand
name: Clinical Research Center of Reunion island
name: Clinical Research Center - Biotherapy center of Nantes
name: CIC 1417 Cochin-Pasteur
name: Pharmacology unit of Créteil
name: Clinical Research Center, Toulouse
First posted: 2009-05-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.
timeFrame: 24 hours
Secondary outcomes:
measure: Total score in the QECIEM questionnaire of comprehension.
timeFrame: 24 hours
measure: Sub-scores in part B (subjective comprehension) of questionnaire of comprehension.
timeFrame: 24 hours
measure: Adhesion to proposed clinical trial protocols
timeFrame: end of the study or end of Lisycom
measure: Impact of complementary oral information on the QECIEM scores
timeFrame: 24 hours
measure: Subjective evaluation of readability by the investigator
timeFrame: begin of the study or begin of Lisycom
measure: Number of refusals to sign informed consent form for the proposed trial.
timeFrame: end of the study or end of Lisycom
measure: Score of the QECIEMc
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical Research Center, University Hospital Grenoble
Study officials:
affiliation: Clinical Research Center Grenoble France
name: Jean-Luc CRACOWSKI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paris A, Cracowski JL, Ravanel N, Cornu C, Gueyffier F, Deygas B, Guillot K, Bosson JL, Hommel M. [Readability of informed consent forms for subjects participating in biomedical research: updating is required]. Presse Med. 2005 Jan 15;34(1):13-8. doi: 10.1016/s0755-4982(05)83877-1. French.
citation: Paris A, Cracowski JL, Maison P, Radauceanu A, Cornu C, Hommel M. Impact of French 'Comites de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information. Fundam Clin Pharmacol. 2005 Jun;19(3):395-9. doi: 10.1111/j.1472-8206.2005.00327.x.
citation: Okais C, Paris A, Cracowski JL. [Readability and information density in biomedical research]. Therapie. 2007 Jan-Feb;62(1):17-21. doi: 10.2515/therapie:2007008. Epub 2007 Mar 21. French.
citation: Paris A, Cornu C, Auquier P, Maison P, Radauceanu A, Brandt C, Salvat-Melis M, Hommel M, Cracowski JL. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol. 2006 Feb;20(1):97-104. doi: 10.1111/j.1472-8206.2005.00391.x.
citation: Paris A, Nogueira da Gama Chaves D, Cornu C, Maison P, Salvat-Melis M, Ribuot C, Brandt C, Bosson JL, Hommel M, Cracowski JL. Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study. Fundam Clin Pharmacol. 2007 Apr;21(2):207-14. doi: 10.1111/j.1472-8206.2007.00472.x.