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 compa re clinical, quality-of-life, and economic outcomes in patients with schizo phrenia or schizoaffective disorder who were treated with risperidone or an y of 13 conventional antipsychotic drugs approved for use in the United Sta tes. This I-year trial was designed to approximate conditions of typical cl inical practice: protocol-mandated care was minimized, and all health servi ces (including medication) were provided according to usual community pract ices. Measures of interest included changes in psychiatric symptoms, medica tion side effects, health-related quality of life. satisfaction with drug t herapy, therapy switching, rehospitalization for the management of relapse, thr 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 potent ial value of such trials in setting policy and in clinical practice.