Abstract

WORKSHOP OBJECTIVE: The purpose of this workshop is to develop skills for evaluating alternative measurement strategies for assessing health outcomes and health-related quality of life in clinical trials and pharmacoeconomic studies. A key to having an assessment strategy that leads to meaningful results is the selection of instruments that measure domains of health-related quality of life that are relevant for the purpose of study and target population. We will present and discuss an approach for systematically evaluating questionnaires, rating scales and classification systems for use, singly or in combination, in different types of studies. PARTICIPANTS WHO WOULD BENEFIT: Pharmacoeconomic and health outcomes researchers who want to increase their understanding of the issues involved in selecting meaningful and responsive quality of life instruments for use in clinical trials and other evaluative studies. Health outcomes and quality-of-life assessment is becoming increasingly important in the evaluation of pharmaceutical products, in terms of labeling claims and product promotion as well as in terms of formulary decisions. Each of these applications requires an assessment strategy that provides information relevant for decision-making. How is a successful assessment strategy developed? What criteria, including reliability, validity and responsiveness, should be used when evaluating instruments for use in a clinical trial or pharmacoeconomic study? This workshop will address these questions and introduce an analytic framework that participants can apply in their daily experience.

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