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Interest in measuring qualitative aspects of life that are most closely related to health and healthcare has increased in recent years. Methods of describing patients' subjective health status now incorporate standardised measures, and several psychometric measures are available. Despite the thousands of empirical and conceptual papers in the medical and pharmacological literature on health-related quality of life (HR-QOL), the value of such measures in the regulatory process is still being debated. We conducted an assessment to understand and document the position of the European Agency for the Evaluation of Medicinal Products (EMEA) on the use of HR-QOL measures in studies conducted for regulatory purposes. Official documents produced and circulated by the EMEA containing recommendations on trial design, conduct and analysis for sponsors and scientific experts were independently reviewed by authors to document the position of the Agency on the specific topic of HR-QOL. All documents found in the Agency website on 30 September 1999 were identified and then assessed to: identify diseases or drugs for which formal HR-QOL assessment is recommended; identify measures and methods recommended; and evaluate the reliability of recommendations across documents. Of the 189 documents retrieved, none focused directly on health-related quality of life. A few explicit recommendations were identified for 13 specific drugs or conditions. These recommendations were mostly general and vague, and used nonstandard terminology. In addition, terminology and recommendations were not consistent across documents and, in at least one case, were in contrast with the US Food and Drug Administration (FDA) guidelines. EMEA guidelines incorporating quality-of-life outcomes are welcomed but it is obvious that more detailed guidance is required. Closer collaboration between the EMEA and the FDA is also recommended. Experts from different disciplines should be involved in the preparation of such documents to assure the necessary technical expertise and the representativeness of the various counterparts. [ABSTRACT FROM AUTHOR]

Objective: To investigate the psychometric performance and clinical validity of the 36-Item Short Form (SF-36) health survey when completed by asymptomatic HIV-positive Italian patients and to compare their health profile with a representative sample of 2031 Italian citizens (the Italian norm).Patients and Methods: This was an observational, multicentre, cross-sectional survey. Microbiologists throughout Italy recruited asymptomatic HIV-positive individuals who were aged at least 18 years and aware of their infection. Investigators collected demographic, social, clinical and treatment data. Patients, classified into 2 clinical categories (A1 and A2) according to explicit pre-defined criteria, completed the SF-36 health survey in the context of a medical visit.Results: Between April and July 1996, 46 microbiologists recruited 214 patients (201 evaluable). No inconsistent responses were observed in 96% of the sample. The usually recommended psychometric standards were satisfied, and the internal consistency reliability indices were always greater than 0.70. Weak to moderate associations were found between SF-36 health survey scores and physicians' estimates of patients' physical performance, while no significant associations were found with CD4+ counts. On average, HIV-positive patients reported lower scores than the Italian norm, and patients in category A2 showed lower scores than patients in A1. These differences were more relevant in scales describing role limitations, general health perception, and psychological well-being.Conclusion: Our study showed that the SF-36 health survey maintained its psychometric properties in a sample of Italian asymptomatic HIV-positive patients and produced data that showed its validity and robustness in such a setting. [ABSTRACT FROM AUTHOR]