The integration of health quality of life in clinical research: experiences from cardiovascular clinical trials.

Health Quality of Life (HQL) assessment in clinical trial and epidemiological research is necessary to determine the efficacy of treatments and interventions. A definition of HQL is presented with the following dimensions of HQL identified: social, physical, and neuropsychological functioning; emotional stability; personal productivity; and intimacy. A strategy for selecting HQL dimensions and measures is discussed and includes consideration of the study population, the intervention(s), and the clinical trial design. Examples from NHLBI-sponsored clinical trials illustrate how HQL measures are selected as well as the goals that HQL assessment can address. That is, the authors discuss how HQL data can be used to characterize the study populations, determine the effects of HQL on critical outcomes, and assess how treatment affects overall HQL and specific dimensions of HQL.