The Measurement of Health-Related Quality of Life in Prospective Drug Therapy Studies in HIV-Infected Patients

The measurement of health-related quality of life (HRQOL) in patients infected with the HIV virus is becoming increasingly important in clinical trials of antiretroviral drugs, principally for two reasons: (1) the disease is becoming a chronic illness, in which the measurement of ‘quality of survival’ is gaining relevance as an outcome measure; and (2) the antiretroviral drugs used to treat the disease may have severe side effects which, in turn, affect the HRQOL of patients and threaten compliance with treatment.A bibliographic review was conducted to locate currently existing HRQOL instruments developed specifically for HIV patients, with demonstrated sensitivity to change, and which may be used as a measure of clinical outcomes. The review also aimed to determine the frequency and adequacy of incorporation of HRQOL as an outcome variable in clinical trials and other prospective drug trials completed between 1990 and 1998 in this group of patients. Although 7 HIV-specific HRQOL instruments with demonstrated sensitivity to change were located (MOS-HIV, MQOL-HIV, HIV-PARSE, HOPES, EORTC-QLQ-HIV, FAHI and AIDS-HAQ), only 2.35% of publications were found to incorporate HRQOL as an outcomes variable. In addition, fewer than 40% of the instruments used to measure HRQOL in the publications reviewed were specific to HIV patients and had demonstrated sensitivity to change. This may be due to: (1) the lack, until relatively recently, of adequate instruments for measuring of HRQOL and changes in HRQOL in HIV patients; (2) the difficulty of measuring HRQOL in HIV patients and; (3) the low importance given to this aspect of the disease to date.