Comparison of Health-Related Quality of Life in Clinical Trial and Nonclinical Trial Human Immunodeficiency Virus-Infected Cohorts

HRQOL was compared in two cohorts to determine if results of clinical trials for patients with HIV infection to patients not in clinical trials can be generalized. The two samples included: (1) a multi-center AIDS clinical group trial, in which most of the patients were white, privately insured, and of high income; and (2) a study conducted among ethnically diverse low-income patients recruited from public clinics. Both studies used 30 HRQOL items, as well as items focusing on symptoms, medications, and demographic characteristics. Results showed that HRQOL scores were significantly lower in the nontrial sample by about 1 standard deviation, even after direct adjustment for clinical and demographic characteristics and after comparison of the nontrial sample with the most symptomatic in the trial sample. This study has major implications for generalizing results to clinical trials in populations not represented in those trials. To assure that results are generalizable, HRQOL must be assessed and compared at baseline.