Development and validation of a specific quality of life module in post-menopausal women with osteoporosis: The QUALIOST (TM)

Established post-menopausal osteoporosis (PMO) has serious consequences on health related quality of life (HRQL), as long-term back and joint pain can severely limit normal activities. The quality of life questionnaire in ost eoporosis (QUALIOST(TM), a self-administered module consisting of 23 questi ons which complements the SF-36, was specifically designed to evaluate the repercussions of PMO on patient HRQL. The QUALIOST(()TM) was developed simu ltaneously in French and English after discussion with 45 patients. A valid ation study in France and the UK included 140 women with PMO, with at least one osteoporotic vertebral fracture. Patients completed the SF-36 and QUAL IOST(TM) twice, 7 days apart. Factorial analysis revealed a physical and em otional component. Three scores were calculated: physical repercussions (10 items), emotional repercussions (13 items) and the global score (23 items) . Internal reliability and stability over time were excellent. Concurrent v alidity with the SF-36 physical and mental fields was satisfactory. A deter ioration in clinical state, as measured by pain severity, hospital admissio n and walking stick use, increased the repercussions on HRQL for all three scores, demonstrating the clinical validity of the questionnaire. The QUALI OST(TM), combined with the SF-36, is a valid rating scale for measuring HRQ L in clinical trials for established PMO, providing both general and specif ic data on the effects of PMO on patient HRQL.