Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial

Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing com-prehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The pri-mary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competenc