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

Comprehension Clinical Trial

— LISYCOM  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908557
• Other study ID #: DCIC 08 15
• Status: Completed
• Phase: N/A
• First received: May 26, 2009
• Last updated: September 11, 2014
• Start date: April 2009
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Comprehension

Intervention

Other:
• readability improvement and good practice redaction
improvement using Flesch readability index and good practice in redaction of informed consent documents.
• Control
information based on the classic informed consent document

Locations

Country	Name	City	State
France	Clinical Research Center, University Hospital Grenoble	Grenoble

Sponsors (14)

Lead Sponsor

Collaborator

University Hospital, Grenoble

Clinical Research Center - Biotherapy center of Nantes, Clinical Research Center - biotherapy center of Saint-Louis, Paris, Clinical Research Center - Vacine center of Cochin - Pasteur, Paris, Clinical Research Center of Bichat, Paris, Clinical Research Center of Clermont-Ferrand, Clinical Research Center of Grenoble, Clinical Research Center of Lyon, Clinical Research Center of Reunion island, Clinical Research Center of Saint-Etienne, Clinical Research Center of Strasbourg, Clinical Research Center, Toulouse, Hôpital Necker-Enfants Malades, Pharmacology unit of Créteil

Country where clinical trial is conducted

France, 

References & Publications (5)

Okaïs C, Paris A, Cracowski JL. [Readability and information density in biomedical research]. Therapie. 2007 Jan-Feb;62(1):17-21. Epub 2007 Mar 21. French. — View 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. — View Citation

Paris A, Cracowski JL, Maison P, Radauceanu A, Cornu C, Hommel M. Impact of French 'Comités 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. — View 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. French. — View Citation

Paris A, Nogueira da Gama Chaves D, Cornu C, Maison P, Salvat-Mélis 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.		24 hours	No
Secondary	Total score in the QECIEM questionnaire of comprehension.		24 hours	No
Secondary	Sub-scores in part B (subjective comprehension) of questionnaire of comprehension.		24 hours	No
Secondary	Adhesion to proposed clinical trial protocols		end of the study or end of Lisycom	No
Secondary	Impact of complementary oral information on the QECIEM scores		24 hours	No
Secondary	Subjective evaluation of readability by the investigator		begin of the study or begin of Lisycom	No
Secondary	Number of refusals to sign informed consent form for the proposed trial.		end of the study or end of Lisycom	No
Secondary	Score of the QECIEMc		1 year	No