抄録
Under the prevailing ”disease-oriented” paradigm of health, Quality of Life (QOL) has been treated with profound skepticism. Two facts, however, militate for taking QOL seriously into account : first, both social and clinical decision making today require evidence presented in the form of patient outcomes; second, of patient outcomes, one of the most important from the patient's standpoint is QOL. Giving several examples, the author discusses why traditional endpoints are insufficient and why patient-based outcomes are relevant in modern social and clinical decision making.
And yet not all outcomes are relevant : for the purposes of assessment of health and medical care, QOL should be confined to its health-related elements, and instruments to measure health-related quality of life (HRQOL) should be rigorously tested with psychometric methods. Even more important, however, is the instrument's content validity : i. e., whether it measures what one wants to measure. This paper lists criteria for selection of appropriate instruments and describes the recent debate and moves to formulate guidelines on the use of HRQOL evidence in pharmaceutical product approvals and manufacturers' product efficacy claims. Finally, the author discusses the future of HRQOL research and uses of HRQOL in clinical practice.
