Preliminary Focus Groups and Interviews
Our review of the literature showed several unre-solved deficiencies in the informed consent process that could be addressed in a well-designed multime-dia tool. The major problems were the inability of some patients to read and comprehend many consent forms, the inadequacy and variability of the oral ex-planations of informed consent, and the lack of doc-umentation of comprehension of the consent forms. To supplement these findings and to inform the de-sign of our prototype multimedia tool for informed consent, we performed a preliminary needs assess-ment using focus groups and interviews with pa-tients, health care professionals, and members of our institutional review board, as outlined below: