[Informed consent, what information is left after a therapeutic trial?].
In order to evaluate the outcome of information given to patients included in a therapeutic trial after having signed a consent form, 77 patients (68 men, 9 women with an average age of 57.9 years) included in the IMPACT study (multicenter, randomised, double-blind protocol, the main objective of which was to assess the antiarrhythmic effect of oral administration of delayed action mexiletine in patients with a recent myocardial infarction), answered a questionnaire of 85 items. The quantity and degree of comprehension of the recalled information at the end of the trial were appreciated from the replies to 13 questions based on the definition or understanding of the most important details of the consent form and on a comprehension score with a maximum value of 14 points. The global quantity of information recalled after an interval ranging from 5 to 21 months was estimated at 60% of the information provided but the recall was not uniform according to the different elements of the consent form: the aim of the study, the concept of placebo, the nature of the active treatment, the randomisation and possible side effects were only correctly apprehended by 40 to 50% of patients: the type of patient included, the duration of the trial, the content of the gelules, the division between treatment/placebo and the concept of double-blind were known to 50 to 75% of participants: the sites of the test centres, the possibility of unmasking the "blind" are of withdrawing from the trial were correctly understood in 75 to 90% of cases. The global average comprehension score was 8.7.(ABSTRACT TRUNCATED AT 250 WORDS)
Gallet
M
M
Département de cardiologie, centre hospitalier St-Joseph et St-Luc, Lyon.
Aupetit
J F
JF
Servan
E
E
Lestaevel
M
M
Lopez
M
M
Chassoux
G
G
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008801:Mexiletine / Q000627:therapeutic use; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy; D010349:Patient Compliance; D010817:Physician-Patient Relations; D010919:Placebos; D011795:Surveys and Questionnaires
D010919:Placebos; D008801:Mexiletine
Consentement informé, que reste-t-il de l'information au terme d'un essai thérapeutique?