title: Measuring quality of life in early HIV disease: the modular approach.
abstract: BACKGROUND
  to examine the reliability and validity of the General Health Self-assessment, a modular questionnaire for self-assessment of quality of life (QoL) in human immunodeficiency virus (HIV) clinical trials and to describe the baseline QoL of participants in a large HIV clinical trial.
  
  
  METHODS
  the domains assessed include health perceptions, physical, psychological and role/social functioning, health care utilization and symptom distress.
  
  
  METHODS
  1,694 subjects with early HIV infection enrolled in the AIDS Clinical Trials Group Protocol 175 completed the scale at baseline.
  
  
  RESULTS
  the domains demonstrated reliability, construct and discriminant validity. A worse QoL was associated with recent hospitalization and symptomatic status. Prior antiretroviral therapy was associated with higher health perceptions and well-being. The presence of symptom distress was related to lower QoL on the other scales. There was no relationship between QoL scales and the baseline CD4 count. Women showed a lower QoL than men on all scales, while ethnicity was related to differences in health perceptions and physical and psychological functioning.
  
  
  CONCLUSIONS
  the General Health Self-assessment shows excellent potential as a measure of QoL for HIV-infected patients in clinical trials. Further research is necessary to determine the responsiveness of the scale to clinical and immunological changes in HIV-infected individuals.
authors.affiliation: Phase V Technologies, Inc., Wellesley, MA 02181, USA.
authors.forename: W R
authors.initials: WR
authors.lastname: Lenderking
authors.forename: M A
authors.initials: MA
authors.lastname: Testa
authors.forename: D
authors.initials: D
authors.lastname: Katzenstein
authors.forename: S
authors.initials: S
authors.lastname: Hammer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004341:Drug Evaluation; D005163:Factor Analysis, Statistical; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires