Enhancing comprehension of consent for research in older patients with psychosis: a randomized study of a novel consent procedure.

Abstract

The ability of individuals with schizophrenia to provide informed consent for research has become the focus of public debate. The authors examined whether a novel consent procedure improved the comprehension of consent for older patients with psychosis. Fifty outpatients with schizophrenia or other psychotic disorders and 19 normal comparison subjects aged 40-80 were randomly assigned to groups given either a routine or an enhanced consent procedure. The latter utilized a computerized presentation that included sequential bullet points and summaries of key information. A posttest measured comprehension of consent-relevant information. A significantly greater proportion of patients who received the enhanced consent procedure scored 100% on first and second trials of the posttest, compared to those receiving the routine procedure (trial 1: 42.3% versus 8.3%; trial 2: 80.8% versus 45.8%, respectively). The enhanced consent method improved comprehension of information relevant for consent in older patients with psychosis.