Abstract:
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Quality of life has become a recognized and accepted endpoint in biomedical and clinical research. In fact, outcomes related to QOL may be the primary endpoints in studies where mortality differences are not anticipated. The development of valid and reliable measures of QOL, plus growing evidence that QOL is sensitive and responsive to important biological and clinical changes, have led to its inclusion in clinical trials and quality-of-care evaluations across a spectrum of medical illnesses and conditions. This presentation will provide an overview of the key psychometric issues involved selecting QOL measures, determining their performance characteristics in various samples, and analyzing whether QOL has changed in a clinically significant way in intervention studies. Strategies and developments in the area of item response theory, and implications for QOL assessment will be discussed. Examples drawn from, but not limited to, cardiovascular, end-stage organ disease, and organ transplant populations will be used to illustrate the major issues considered in this presentation.
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