title: Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.
abstract: OBJECTIVE
  The aim was to evaluate the comprehension of participants of an improved informed consent document (ICD).
  
  
  METHODS
  This was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehension.
  
  
  RESULTS
  Four hundred and eighty-one patients were included, 241 patients in the original ICD group and 240 patients in the modified ICD group. There was no difference between the two groups for the score of objective comprehension (original ICD 72.7 (95% CI 71.3, 74.1) vs. modified ICD 72.5 (95% CI 71.0, 74.0); P = 0.81). However, the rate of enrolment in the clinical study was lower in the group who received the modified ICD (64.4% (95% CI 58.3, 70.5)) than for the original ICD (73.0% (95% CI 67.4, 78.7)) (P = 0.042). Only female gender and high educational level were associated with a better objective comprehension.
  
  
  CONCLUSIONS
  Improving ICDs had no effect on participants' understanding, whereas the rate of enrolment was lower in this group. In attempts at improving potential participants' understanding of clinical research information, efforts and future trials should focus on other ways to improve comprehension.
authors.affiliation: Inserm CIC1406, Centre d'Investigation Clinique de Grenoble, Grenoble Cedex 9, F-38043.
authors.forename: Adeline
authors.initials: A
authors.lastname: Paris
authors.affiliation: Inserm CIC1408, Centre d'Investigation Clinique de Saint-Etienne, Saint Priest En Jarez, F-42270.
authors.forename: Béatrice
authors.initials: B
authors.lastname: Deygas
authors.affiliation: Centre d'Investigation Clinique de Lyon, Inserm CIC1407, Bron, F-69677.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
authors.affiliation: Inserm CIC 1436 Toulouse, Department of Clinical Pharmacology, Toulouse University Hospital, Toulouse.
authors.forename: Claire
authors.initials: C
authors.lastname: Thalamas
authors.affiliation: Hôpital Henri MONDOR, Unité de Recherche Clinique, Creteil, F-94010.
authors.forename: Patrick
authors.initials: P
authors.lastname: Maison
authors.affiliation: Inserm CIC1405, Centre de pharmacologie Clinique, CHU Clermont-Ferrand, Clermont-Ferrand, F-63003, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Duale
authors.affiliation: Inserm CIC1406, Centre d'Investigation Clinique de Grenoble, Grenoble Cedex 9, F-38043.
authors.forename: Maty
authors.initials: M
authors.lastname: Kane
authors.affiliation: Inserm CIC1406, Centre d'Investigation Clinique de Grenoble, Grenoble Cedex 9, F-38043.
authors.forename: Enkelejda
authors.initials: E
authors.lastname: Hodaj
authors.affiliation: Inserm CIC1406, Centre d'Investigation Clinique de Grenoble, Grenoble Cedex 9, F-38043.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Cracowski
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D035842:Research Subjects / Q000523:psychology* / Q000706:statistics & numerical data*
keywords: biomedical research; comprehension; informed consent; questionnaire