The development of a valid and reliable instrument that can be used in clinical trials to assess quality of life (QOL) in persons with AIDS (PWA) has been identified internationally as a public health priority. Because of the seriousness of AIDS and the increasing numbers of PWA, new therapies and treatment options are constantly being tested. Quality of life has been identified as an important outcome in public health and clinical research. Although several well-established QOL measures already exist, most are not suitable for large-scale clinical trials or for PWA. Measures specifically developed for PWA are often not psychometrically sound. The final product of this initiative will be an easily administered multi-dimensional QOL measure, designed especially for PWA, that is sensitive enough to discriminate QOL differences between treatment alternatives in clinical trials evaluating medical or treatment interventions. Standard procedures for scale development will be used: (1) development of a pool of items that tap different dimensions of QOL; (2) focus groups with persons with AIDS and health care providers working predominantly with AIDS patients; (3) construction of a draft instrument item on each dimension; (4) piloting of instrument on relevant samples; (5) examination of psychometric properties of the instrument; and (6) development of a final instrument to be tested in Phase II. Phase II will consist of conducting validity and reliability studies of the instrument on relevant populations, as well as additional focus group testing.
