Patients' perceptions on informed consent and the quality of information disclosure in clinical trials.
In a survey on 26 clinical trials we studied how patients experience and evaluate the information disclosure on the clinical trial they are enrolled in and which factors influence patients' perceptions of information disclosure. Our objective was to obtain more insight thereby in how informed consent is applied in the daily practice of clinical trials. Interviews were held with 198 adult patients and 32 trial-clinicians. Instead of focusing on patient comprehension of the information disclosed we analyzed patient perceptions of informed consent. Patients proved to be quite satisfied with the oral and written information disclosure. Patients' perceptions of the manner and content of information disclosure are influenced by more general attitudes towards medical care, research and institutions. Patients' trust in medical experiments, belief in the integrity of physicians and interest in medical affairs have an impact on the way patients perceive information disclosure. To improve the quality of the informed consent procedure, we propose a patient motivation classification (PMC) to enable trial-clinicians to gain more insight into patient motivation. Relevant factors found in our data have been used as criteria for classification. An informed decision making checklist (IDC) is suggested for patients as a general outline for patient education, covering relevant socio-psychological factors of enrollment.
Verheggen
F W
FW
Quality Council, University Hospital Maastricht, The Netherlands.
Jonkers
R
R
Kok
G
G
D001294:Attitude to Health; D002986:Clinical Trials as Topic; D032882:Comprehension; D030881:Disclosure; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010353:Patient Education as Topic / Q000592:standards*; D010817:Physician-Patient Relations; D018570:Risk Assessment; D011795:Surveys and Questionnaires; D014342:Truth Disclosure