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Futuristic forum for personalized infectious disease medicine

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Author Version - Cover Page MURDOCH RESEARCH REPOSITORY http://researchrepository.murdoch.edu.au/9396/ Herrmann, S., Duracinsky, M., Lalanne, C., Acquadro, C., Mallal, S. and Nolan, D. (2009) Health-related quality of life in the WA HIV Cohort: 2008. In: 21st Annual Conference of the Australasian Society for HIV Medicine (ASHM), 9 - 11 September, Brisbane, Australia. Presentation It is posted here for your personal use. No further distribution is permitted. 1 Western Australian HIV Cohort Study Western Australian HIV Cohort Study Herrmann S, Duracinsky M, Lalanne C, McKinnon E, Acquadro C, Mallal S, Nolan D HEALTH-RELATED QUALITY OF LIFE IN THE WA HIV COHORT: 2008 IntroductionIntroduction • Health related quality of life (HRQL) is a major concern in the clinical care of people living with HIV. • Measuring quality of life (QOL) is one way of assessing the patients experience with long term therapies and other psychosocial dimensions of living with the infection. • Patient reported outcomes (PRO), measure HRQL – their use is mandatory during the drug approval process. • PRO instruments currently used were devised for generic health assessment and during the early HAART period. 1. EMEA/CHMP/EWP/139391/2004. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. London, EMEA, 2005. 2. 2. Draft Guidance for Industry – Patient-reported Outcomes Measures: Use in Medical Product Development to support Labeling Claims. Docket 2006D-0044, FDA Federal Register, 2006. IntroductionIntroduction • A new Patient-Reported Outcomes questionnaire to measure QOL in people living with HIV/AIDS has been developed. • The instrument, PROQOL-HIV, has undergone psychometric validation in 791 individuals from 8 countries including 102 people from the WA HIV Cohort Study. Here

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