Improving informed consent of surgical patients using a multimedia-based program? Results of a prospective randomized multicenter study of patients before cholecystectomy.

Abstract

The term "informed consent" explains the process by which a patient, before treatment, is provided comprehensive and impartial information regarding a planned operative procedure so that he/she understands the implications of the procedure before consenting. The goal of the current study was to investigate whether standard methods of consenting can be improved using a multimedia-based information program (MM-IP). In a prospective multicenter study, 80 patients undergoing laparoscopic cholecystectomy went through the standard informed consent process. One group of patients was also given access to a MM-IP. Questionnaires were completed before surgery. These evaluated how patients perceived their own understanding of important aspects of their illness (ie, disease, therapeutic alternatives, operation, risks) and satisfaction with the consenting process. Patients' anxiety levels were also assessed. These questionnaires were used to evaluate the effectiveness of the MM-IP for improving the consent process. Seventy-six patients (47 women, 29 men, median age 54 years) were included. There was no significant age or gender variation between the groups (standard n = 41 and MM-IP n = 35). Eighty-two percent of all respondents were satisfied with the standard informed consent process. However, perceived understanding of the material was significantly improved in the MM-IP group (P < 0.001). Patients with less formal education profited particularly from the MM-IP. Preoperative anxiety did not vary between the groups. Use of the multimedia-based program was positively evaluated by patients, and significantly improved patients' perceived understanding of their disease and its treatment. It is, therefore, valuable in the informed consent process.