Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies

Gale Harding,Seema Haider,Margaret Tawadrous,Kit N Simpson,Albert W Wu,Chris L Pashos,Alexandra Khachatryan,Kristin A Hanson

doi:10.1186/1477-7525-11-42

Abstract

BackgroundSelection of an appropriate patient-reported outcome (PRO) instrument for a clinical trial requires knowledge of the instrument’s responsiveness to detecting treatment effects. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D).MethodsA systematic review identified clinical trials using the MOS-HIV or EQ-5D to assess outcomes for HIV-infected adults. Data abstracted from each study included study type, treatment regimen(s), PRO results, and effect size (either reported or calculated). Effect size was calculated as the difference between baseline and follow-up mean scores divided by the baseline standard deviation. Magnitude was categorized as small (d=0.20), medium (d=0.50), and large (d=0.80).ResultsBetween 2005 and 2010, the MOS-HIV was administered in 12 trials. Significant differences were observed between groups and over time in physical health summary (PHS) and mental health summary (MHS) scores (P<0.05) in subjects switching therapy after experiencing Grade-2 adverse events. Effect sizes were medium (0.55 and 0.49 for PHS and MHS, respectively) among treatment-naïve adults beginning therapy (two studies), but negligible among treatment-experienced adults (0.04 and 0.13 for PHS and MHS, respectively; three studies). The EQ-5D was used in five trials between 2001 and 2010. It was responsive to occurrences of adverse events and opportunistic infections, with small-to-medium effect sizes (range 0.30–0.50) in each of its five dimensions.ConclusionsA systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and/or over time in treatment-naïve HIV-infected patients. These instruments may be used either individually or together in clinical trials to measure changes in HRQL.

Highlights

The use of highly active antiretroviral therapy (HAART) has improved survival of persons with HIV infection to the extent that HIV-disease is considered a chronic condition, with treatment goals focused on optimizing health-related quality of life (HRQL) rather than only on improving survival
Medical Outcomes Study HIV Health Survey (MOS-HIV) Between 2005 and 2010, the MOS-HIV was administered in 12 clinical trials
Summarized across studies, the MOS-HIV demonstrated the ability to detect change over time in both physical and mental health summary scores among treatment-naïve adults initiating antiretroviral (ARV) therapy. This was not seen uniformly, as effect sizes were negligible in three HIV studies evaluating therapy modifications in treatment-experienced adults (Table 1)

Summary

Introduction

The use of highly active antiretroviral therapy (HAART) has improved survival of persons with HIV infection to the extent that HIV-disease is considered a chronic condition, with treatment goals focused on optimizing health-related quality of life (HRQL) rather than only on improving survival. We selected one HIV-targeted HRQL instrument, the Medical Outcomes Study HIV Health Survey (MOS-HIV), and one generic HRQL instrument, the EQ-5D, for detailed assessment. Both instruments are widely used in clinical trials and observational studies and are translated into more than 20 languages [3,4]. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D)

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