title: A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials.
abstract: With the advent of highly active antiretroviral therapy (HAART), HIV-infected patients are living longer and are concerned not only with a treatment's ability to extend their life but also with the quality of the life they are able to lead. Regulatory authorities are also paying closer attention to the use of health-related quality-of-life (HR-QOL) measures in clinical trials and to the subsequent claims that are made based on the results. This paper reviews existing HR-QOL measures reported in the HIV/AIDS literature since 1990 and identifies those most worthy of consideration for use in future clinical trials.A comprehensive review following predefined selection criteria was conducted. Generic and HIV-targeted measures were assessed for content and practicality for the clinical trial setting. The generic measures were additionally reviewed for the ability to produce preference-based index scores and for the existence of normative general population data. Three generic and six HIV-targeted measures met these selection criteria and were then assessed more fully in terms of their development (HIV-targeted measures), psychometric properties and appropriateness for use in clinical trials.It was determined that each of the selected generic measures (i.e. Medical Outcomes Study [MOS] 36-Item Short Form Survey Instrument [SF-36], EQ-5D, Health Utilities Index [HUI]) could serve as a useful adjunct to an HIV-targeted measure in a trial. The Functional Assessment of HIV Infection (FAHI) and MOS-HIV health survey were deemed the two most appropriate HIV-targeted measures. Each of the measures can be self-administered in < or = 10 minutes and there was ample evidence of their excellent psychometric properties. However, they would not be optimal in all HIV-infected subgroups (e.g. treatment naive vs advanced; adolescents vs older adults) targeted for clinical trial interventions. Although there is no one best HR-QOL measure for use in HIV/AIDS clinical trials, based on our review criteria we identified three generic and two HIV-targeted candidate measures. However, these measures have their limitations and it is clear that greater consensus needs to develop regarding more effective and efficient approaches to HR-QOL measurement in HIV/AIDS clinical trials. Along with the increasingly complex HR-QOL measurement task resulting from changes in the HIV-infected population and shifts in the HR-QOL burden associated with HIV infection and its treatment over the past 25 years, it is increasingly important that HR-QOL outcomes become viable endpoints in HIV/AIDS clinical trials.
authors.affiliation: PharmaQuest Ltd, Banbury, Oxfordshire, UK. darren.clayson@pharmaquest-ltd.com
authors.forename: Darren J
authors.initials: DJ
authors.lastname: Clayson
authors.forename: Diane J
authors.initials: DJ
authors.lastname: Wild
authors.forename: Paul
authors.initials: P
authors.lastname: Quarterman
authors.forename: Isabelle
authors.initials: I
authors.lastname: Duprat-Lomon
authors.forename: Maria
authors.initials: M
authors.lastname: Kubin
authors.forename: Stephen Joel
authors.initials: SJ
authors.lastname: Coons
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000523:psychology*; D002986:Clinical Trials as Topic; D015658:HIV Infections / Q000188:drug therapy / Q000523:psychology*; D006304:Health Status; D006306:Health Surveys; D006801:Humans; D011594:Psychometrics; D011788:Quality of Life