Abstract
The interest in including health-related quality of life (HRQOL) as an outcome measure in therapeutic clinical trials has spread to countries throughout the world. Because clinical research within the pharmaceutical industry is increasingly international in scope, the demand for reliable, valid, and sensitive HRQOL measures that can be used in the same trial cross nationally has become acute.
Criteria by which HRQOL measures are evaluated for inclusion in international clinical trials have yet to be precisely defined. Moreover, experts in the quality of life field do not always agree on whether an HRQOL measure is applicable for cross-national research. Thus, clear guidelines for identifying existing measures for use in international trials do not exist.
This paper identifies guidelines by which existing HRQOL measures can be evaluated for cross-national clinical research. The paper includes a review of the HRQOL concept, a description of basic principles of psychometric measurement, and an examination of the clinical trial context in which these instruments are frequently employed.
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