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A Comparative Review of Health-Related Quality-of-Life Measures for Use in HIV/AIDS Clinical Trials

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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 ≤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 HIVtargeted 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.

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Acknowledgements

The review was funded by Bayer Healthcare. I. Duprat-Lomon is an employee of Bayer Pharma and M. Kubin is an employee of Bayer Healthcare, the sponsors of this study. The co-authors from Bayer have no conflicts of interest to declare. At the time this review was conducted, D.J. Clayson was an employee of Oxford Outcomes Ltd.

The authors have no other conflicts of interest to declare.

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Authors and Affiliations

  1. PharmaQuest Ltd, Jeffersons Business Centre, 6 South Bar, Banbury, Oxfordshire, OX16 9AA, UK

    Darren J. Clayson

  2. Oxford Outcomes Ltd, Cassington, Oxford, UK

    Diane J. Wild & Paul Quarterman

  3. Bayer Pharma, Puteaux Cedex, France

    Isabelle Duprat-Lomon

  4. Bayer Healthcare, Wuppertal, Germany

    Maria Kubin

  5. The University of Arizona College of Pharmacy, Tucson, Arizona, USA

    Stephen Joel Coons

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  1. Darren J. Clayson
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  2. Diane J. Wild
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  4. Isabelle Duprat-Lomon
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  5. Maria Kubin
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Correspondence to Darren J. Clayson.

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Clayson, D.J., Wild, D.J., Quarterman, P. et al. A Comparative Review of Health-Related Quality-of-Life Measures for Use in HIV/AIDS Clinical Trials. Pharmacoeconomics 24, 751–765 (2006). https://doi.org/10.2165/00019053-200624080-00003

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