Health-related quality of life in a randomized trial of antiretroviral therapy for advanced HIV disease.

OBJECTIVE: To assess and compare alternative approaches of measuring preference-based health-related quality of life (HRQoL) in treatment-experienced HIV patients and evaluate their association with health status and clinical variables.
DESIGN: Cross-sectional study.
SETTING: Twenty-eight Veterans Affairs hospitals in the United States, 13 hospitals in Canada, and 8 hospitals in the United Kingdom. PATIENTS: Three hundred sixty-eight treatment-experienced HIV-infected patients enrolled in the Options in Management with Antiretrovirals randomized trial. MEASUREMENTS: Baseline sociodemographic and clinical indicators and baseline HRQoL using the Medical Outcome Study HIV Health Survey (MOS-HIV), the EQ-5D, the EQ-5D visual analog scale (EQ-5D VAS), the Health Utilities Index Mark 3 (HUI3), and standard gamble (SG) and time trade-off (TTO) techniques.
RESULTS: The mean (SD) baseline HRQoL scores were as follows: MOS-HIV physical health summary score 41.70 (11.16), MOS-HIV mental health summary score 44.76 (11.38), EQ-5D 0.77 (0.19), HUI3 0.59 (0.32), EQ-5D VAS 65.94 (21.71), SG 0.75 (0.29), and TTO 0.80 (0.31). Correlations between MOS-HIV summary scores and EQ-5D, EQ-5D VAS, and HUI3 ranged from 0.60 to 0.70; the correlation between EQ-5D and HUI3 was 0.73; and the correlation between SG and TTO was 0.43. Preference-based HRQoL scores were related to physical, mental, social, and overall health as measured by MOS-HIV. Concomitant medication use, CD4 cell count, and HIV viral load were related to some instruments' scores.
CONCLUSIONS: On average, preference-based HRQoL for treatment-experienced HIV patients was decreased relative to national norms but also highly variable. Health status and clinical variables were related to HRQoL.

RCT Entities:   Population Interventions Outcomes