Clinical effectiveness: the importance of psychosocial functioning outcomes.

BACKGROUND Major depressive disorder (MDD) is associated with significant impairment in quality of life and psychosocial functioning, including social and occupational/role functioning. Evaluation of clinical effectiveness of treatments for depression must include improvement in these important functional outcomes. However, clinical trials for depression have primarily focused on reduction in symptoms, as measured by symptom severity scales such as the HDRS and MADRS or by standard definitions of response and remission. METHOD The rationale and necessity for accessing both symptom and functional outcomes in clinical trials for MDD are reviewed, and examples of validated scales for measuring QoL and social and occupational functioning are provided. RESULTS Emerging data suggest that treatment effects assessed with functioning scales may differ from those captured by symptoms scales. Many validated scales are available to measure global and specific aspects of functional outcomes, including QoL, psychosocial functioning and occupational functioning. Nevertheless, systematic reviews have shown that functional outcome scales are used in fewer than 5% of trials. CONCLUSIONS Given the importance of psychosocial functioning for the individual with MDD as well as for society, greater attention must be focused on the assessment of functional outcomes in clinical trials for MDD, as well as in the clinical management of people with depression.