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[Informed consent, what information is left after a therapeutic trial?]
M Gallet1, J F Aupetit, E Servan
1Département de cardiologie, centre hospitalier St-Joseph et St-Luc, Lyon.
Archives Des Maladies Du Coeur Et Des Vaisseaux
|January 1, 1994
Summary
Patients in a clinical trial recalled 60% of information from their consent forms. Key details like study aims and side effects were understood by only 40-50% of participants, highlighting a need for improved patient comprehension strategies.
Area of Science:
- Clinical Trials
- Patient Information & Consent
- Cardiology
Background:
- Informed consent is crucial for patient participation in clinical trials.
- Assessing patient recall of consent information is vital for ethical trial conduct.
- The IMPACT study investigated mexiletine for recent myocardial infarction.
Purpose of the Study:
- To evaluate patient recall and comprehension of information provided in a therapeutic trial consent form.
- To identify specific areas of consent information that are well-understood versus poorly understood by trial participants.
Main Methods:
- A questionnaire of 85 items was administered to 77 patients (68 men, 9 women; average age 57.9 years) from the IMPACT study.
- Patient recall of consent form details was assessed via 13 specific questions and a comprehension score (max 14 points).
- Recall was evaluated 5 to 21 months after trial completion.
Main Results:
- Patients recalled approximately 60% of the total information provided in the consent form.
- Recall varied significantly across different consent elements, with study aims, placebo, active treatment, randomization, and side effects understood by only 40-50% of patients.
- Information regarding trial centers, unblinding, and withdrawal rights was understood by 75-90% of patients.
- The global average comprehension score was 8.7 out of 14 points.
Conclusions:
- Patient recall of clinical trial consent information is incomplete and uneven.
- Critical elements of trial protocols, such as study objectives and potential risks, require enhanced communication strategies.
- Further research is needed to optimize patient understanding of informed consent documents in therapeutic trials.