The Risperidone Outcomes Study of Effectiveness (ROSE): a model for evaluating treatment strategies in typical psychiatric practice.

We describe the design of a multicenter, randomized clinical trial to compare clinical, quality-of-life, and economic outcomes in patients with schizophrenia or schizoaffective disorder who were treated with risperidone or any of 13 conventional antipsychotic drugs approved for use in the United States. This 1-year trial was designed to approximate conditions of typical clinical practice: protocol-mandated care was minimized, and all health services (including medication) were provided according to usual community practices. Measures of interest included changes in psychiatric symptoms, medication side effects, health-related quality of life, satisfaction with drug therapy, therapy switching, rehospitalization for the management of relapse, the use of psychiatric services of all types, and the cost of psychiatric care. We review the rationale for this type of trial and discuss the potential value of such trials in setting policy and in clinical practice.