Article date: March 2010
By: Adeline Paris, Christian Brandt, Catherine Cornu, Patrick Maison, Claire Thalamas, Jean‐Luc Cracowski, in Volume 69, Issue 3, pages 231-237
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Before enrolment, an informed consent (IC) document must be given to all participants by the investigator.
• Most IC documents are long, contain much information and are difficult to understand.
• Some methods to improve comprehension were tested, but they had limited effects.
WHAT THIS STUDY ADDS
• We failed to show that improving IC document comprehension through a lexicosyntactic approach or by a working group leads to better comprehension in our patient population, whichever method was used.
• We confirm too that a study in real conditions is necessary.
AIMS International guidelines on ethics in biomedical research require that the informed consent of all enrolled participants is obtained. A written document describing the research, the informed consent (IC) document, must be given to all participants by the investigator. Most IC documents are long, containing much information. The aim of the present study was to determine whether the modification of the IC document by a working group or systematic improvement in its lexicosyntactic readability can improve comprehension of the written information given to patients participating in biomedical research.
METHODS One hundred and fifty‐nine patients were randomized to read one of the three versions of the IC document: unchanged document, document modified using systematic improvement of lexicosyntactic readability and document modified by a working group.
RESULTS Neither the improvement in the lexicosyntactic readability, nor the intervention of the working group significantly improved the score of objective comprehension for the subjects included in this study: it was 66.6 (95% confidence interval 64.0, 69.2) for the control group, 68.8 (66.2, 71.4) for the group with the document improved for lexicosyntactic readability and 69.2 (66.0, 72.4) for the group who read the document improved by the working group (P= 0.38).
CONCLUSIONS We failed to show that improving IC document comprehension through a lexicosyntactic approach or by a working group leads to better comprehension.
DOI: 10.1111/j.1365-2125.2009.03565.x
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