Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT (LISYCOM)
|Comprehension||Other: readability improvement and good practice redaction Other: Control|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
|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.|
- Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension. [ Time Frame: 24 hours ]
- Total score in the QECIEM questionnaire of comprehension. [ Time Frame: 24 hours ]
- Sub-scores in part B (subjective comprehension) of questionnaire of comprehension. [ Time Frame: 24 hours ]
- Adhesion to proposed clinical trial protocols [ Time Frame: end of the study or end of Lisycom ]
- Impact of complementary oral information on the QECIEM scores [ Time Frame: 24 hours ]
- Subjective evaluation of readability by the investigator [ Time Frame: begin of the study or begin of Lisycom ]
- Number of refusals to sign informed consent form for the proposed trial. [ Time Frame: end of the study or end of Lisycom ]
- Score of the QECIEMc [ Time Frame: 1 year ]
|Study Start Date:||April 2009|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Patients receiving an information and consent form that has been modified using the LISYCOM methods.
Other: readability improvement and good practice redaction
improvement using Flesch readability index and good practice in redaction of informed consent documents.
Active Comparator: 2
Patients receiving a standard information and consent form.
information based on the classic informed consent document
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908557
|Clinical Research Center, University Hospital Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||Jean-Luc CRACOWSKI, MD||Clinical Research Center Grenoble France|