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

Objective: The ability of individuals with schizophrenia to provide informe d consent for research has become the focus of public debate. The authors e xamined whether a novel consent procedure improved the comprehension of con sent for older patients with psychosis. Method: Fifty outpatients with schizophrenia or other psychotic disorders a nd 19 normal comparison subjects aged 40-80 were randomly assigned to group s given either a routine or an enhanced consent procedure. The latter utili zed a computerized presentation that included sequential bullet points and summaries of key information. A posttest measured comprehension of consent- relevant information. Results: A significantly greater proportion of patients who received the en hanced consent procedure scored 100% on first and second trials of the post test, compared to those receiving the routine procedure (trial 1: 42.3% ver sus 8.3%; trial 2: 80.8% versus 45.8%, respectively). Conclusions: The enhanced consent method improved comprehension of informat ion relevant for consent in older patients with psychosis.