Simplification and First Validation of a Short Battery of Patient Questionnaires for Clinical Management of HIV-Infected Patients: The HIV-SQUAD (Symptom Quality of life Adherence) Questionnaire®

Abstract

Purpose: Questionnaires assessing patient-reported outcomes in HIV are either too long or not HIV-specific. Our aim was to develop and validate a simplified HIV patient questionnaire. Method: 607 HIV patients treated with a combination of antiretroviral (ARV) drugs were enrolled in an observational, longitudinal study. Questionnaires covering health-related quality of life (HRQoL), satisfaction, tolerability, and adherence were administered at baseline (BL) and Month 3 (M3). The items were selected according to their content and discriminant properties. The simplified questionnaire was then administered at Month 12 (M12). Psychometric properties of physical wellbeing, psychological well-being, and global HRQoL scores were assessed. Results: The simplified questionnaire included 12 HRQoL items, 13 side-effects items, and one visual analog scale (VAS) measuring adherence. The principal component analysis (PCA) confirmed the validity of the global HRQoL score. The multivariate analysis showed acceptable-to-good internal consistency of the three scores. Convergent and discriminant validity were excellent for the physical score. The global score showed significant differences according to time since diagnosis, hepatitis coinfection, CD4 count, and viral load. Conclusion: This questionnaire deals with the major aspects of HIV patient perceptions. The global HRQoL score is well correlated to the surrogate markers of HIV. Such a questionnaire may represent a new tool for the therapeutic management of HIV-infected patients. Further steps are required to complete these results.

Keywords:

• adherence
• HIV infection
• HRQoL
• patient reported outcomes (PRO)
• self-administered questionnaire
• tolerability