, Volume 1, Issue 6, pp 465-476
Date: 25 Oct 2012

Assessing Health-Related Quality of Life Outcomes of Drug Treatments for Psychiatric Disorders

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Summary

There is increasing interest in evaluating the health outcomes and effectiveness of new pharmaceutical treatments for psychiatric disorders, such as depression, anxiety and schizophrenia. There is also increased emphasis on understanding the affect of treatment on patient quality of life.

Few comprehensive health-related quality of life (HRQL) studies have been performed to examine social, occupational and functional outcomes in patients with chronic schizophrenia. The most widely used scales include the Social Adjustment Scale, the Quality of Life Scale and the Quality of Life Interview. New scales, such as the Quality of Life Index for Mental Health, are under development and there is increasing interest in evaluating more broadly the impact of treatment of patient indices of functioning and well-being in schizophrenia. Research, over the last few years, has focused on understanding the impact of major depression and anxiety and treatment for these disorders on HRQL. Existing generic health status measures, such as those developed for the Medical Outcomes Study, are increasingly incorporated into clinical trials of new antidepressant treatments. Unfortunately, most of these have not reached publication. Several depression-specific measures, such as the SmithKline Beecham Quality of Life scale, Quality of Life Enjoyment and Satisfaction Questionnaire, and the Quality of Life in Depression scale, have been developed and are beginning to be used in clinical studies. However, there is only limited information available about the reliability, validity and responsiveness of most of these new scales.

The selection of HRQL measures and the design of HRQL components for clinical trials needs to be guided by the objectives of the research, the target population, and the potential positive and negative consequences of the pharmacological treatment. Selection of specific instruments is based on the relevance of the measure, the reliability and validity of the scale, and practical considerations. The ability of a HRQL scale to discriminate between persons with different severity of disease, and the responsiveness to change are critical treatment evaluations. Practical characteristics include respondent and investigator burden, and the mode of administration of the scale. In the design of a clinical trial, attention must be focused on identifying appropriate data collection intervals to detect important changes in HRQL, if they should occur, and in addressing logistical and practical issues associated with the administration of HRQL scales.