Evaluating the impact of a quality of life assessment with feedback to clinicians in patients with schizophrenia: randomised controlled trial.

BACKGROUND Quality of life (QoL) measurements are increasingly considered to be an important evaluation of the treatment and care provided to patients with schizophrenia. However, there is little evidence that assessing QoL improves patient outcomes in clinical practice. AIMS To investigate the impact of a QoL assessment with feedback for clinicians regarding satisfaction and other health outcomes in patients with schizophrenia. METHOD We conducted a 6-month, prospective, randomised and controlled open-label study. Patients with schizophrenia were assigned to one of three groups: standard psychiatric assessment; QoL assessment with standard psychiatric assessment; and QoL feedback with standard psychiatric assessment. The primary outcome was patient satisfaction at 6 months. The local ethics committee (Comité de Protection des Personnes Sud-Méditerranéee V, France, trial number 07 067) and the French drug and device regulation agency (Agence Française de Sécurité Sanitaire des Produits de Santé, France, trial number A01033-50) approved this study. RESULTS We randomly assigned 124 patients into groups. Quality of life feedback significantly affected patient satisfaction. Global satisfaction was significantly higher in the QoL feedback group (72.5% of patients had a high level of satisfaction) compared with the standard psychiatric assessment (67.5%) and QoL assessment groups (45.2%). Despite trends towards decreased severity for all clinical outcomes and increased changes to medication in the QoL feedback group at 6-month follow-up, these effects were not significant. CONCLUSIONS Quality of life feedback positively influences patient satisfaction, which confirms the relevance of measuring QoL in clinical practice. The absence of a significant effect of QoL feedback on clinical outcomes also suggests that clinicians did not use these data optimally. Our findings suggest a nocebo effect of QoL assessment without feedback that should be considered by researchers and clinicians.