Abstract
BackgroundThe QUALIOST® was designed for use with the SF-36 to measure established osteoporosis-specific quality of life (QoL). The reliability (internal consistency and test-retest) and validity of the questionnaire were established in a stand-alone psychometric validation study. The objective of this paper is to provide additional information on the instrument's responsiveness using clinical trial data, along with the reliability and validity of translated versions.MethodsThe Spinal Osteoporosis Therapeutic Intervention (SOTI) was an international clinical trial comparing strontium ranelate to placebo on the occurrence of new vertebral fracture in patients with postmenopausal osteoporosis. QoL was a secondary endpoint, assessed using the SF-36 and QUALIOST® at baseline and every six months, with the main analysis at 3-year follow-up. Questionnaire acceptability, analysis of the hypothesised structure, internal consistency reliability and responsiveness to clinical change over time were assessed at the 3-year follow up.Results1592 patients from 11 countries completed at least one QoL questionnaire. The psychometric properties of the questionnaires were assessed on cross-sectional (N = 1486) and longitudinal (N = 1288) data. Item discriminant validity of the QUALIOST® was excellent, as was item convergent validity, with 100% of item-scale correlations being above the 0.40 level. Internal consistency reliability was also extremely good, with high Cronbach's alpha scores above the 0.70 benchmark. Responsiveness results were consistent for all QUALIOST® scores, indicating that greater decreases in QoL corresponded to greater numbers of fractures experienced. QUALIOST® scores also differed according to the type of fracture suffered. This was demonstrated by increased effect sizes for more severe vertebral fractures (clinical vertebral and painful vertebral). In comparing responsiveness, the QUALIOST® scores were generally more consistent than those of the SF-36. Most notably, the QUALIOST® was more responsive with regard to painful vertebral fractures than the SF-36.ConclusionThe QUALIOST® is a reliable and valid tool for measuring QoL in postmenopausal osteoporotic women. Being available in several validated language versions, it is ready to be used in a variety of settings, including international clinical trials.
Highlights
The QUALIOST® was designed for use with the SF-36 to measure established osteoporosis-specific quality of life (QoL)
Experiencing a vertebral fracture can result in fear of future vertebral fractures and anxiety is reported early in osteoporosis [1], which often leads to reduced activities
QoL was a secondary endpoint, assessed at baseline and every six months, with the main analysis at the three-year follow-up. 1592 patients from 11 countries completed at least one QoL questionnaire
Summary
The QUALIOST® was designed for use with the SF-36 to measure established osteoporosis-specific quality of life (QoL). Osteoporosis is a debilitating chronic disease that can reduce quality of life (QoL) in a variety of ways, including diminished physical and emotional functioning. Experiencing fractures can lead to reduced mobility and may be very painful, which can limit everyday activities. Experiencing a vertebral fracture can result in fear of future vertebral fractures and anxiety is reported early in osteoporosis [1], which often leads to reduced activities. In 1995, a clinical development program for a new chemical entity, strontium ranelate, was implemented in postmenopausal women with osteoporosis. The SOTI (Spinal Osteoporosis Therapeutic Intervention) study was an international clinical trial comparing strontium ranelate to placebo, according to the double blind procedure, on the occurrence of new vertebral fractures in postmenopausal patients with established osteoporosis. The prevalent and incident vertebral fractures were diagnosed using the semi-quantitative method (HK Genant [2]), a visual radiographic approach with specified fracture definitions, routinely used in clinical studies
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