Quality of life in patients with vertebral fractures: Validation of the quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO)

Vertebral fractures may be minor or lead to pain, decreased physical functi on, immobility, social isolation and depression, which together contribute to quality of life. A Working Party of the European Foundation for Osteopor osis has developed a specfic questionnaire for patients with vertebral frac tures. This questionnaire, QUALEFFO, includes questions in the domains pain , physical function, social function, general health perception and mental function. QUALEFFO was validated in a multicenter study in seven countries. The study was done in 159 patients aged 55-80 years with clinical osteopor osis, i.e., back pain and other complaints with at least one vertebral frac ture and lumbar bone mineral density T-score <-1. Patients with a recent ve rtebral fracture were excluded because of unstable disease. Controls were a ge- and sex-matched, and did not have chronic back pain or vertebral fractu res. Subjects with conditions exerting a major influence on quality of Life were excluded. The QUALEFFO was administered twice within 4 weeks and comp ared with a generic questionnaire, the Short Form 36 of the Medical Outcome s Study (SF-36). Standard spinal radiographs were made for assessment of ve rtebral height. Seven questions were removed from the analysis because of l ow response rate, linguistic ambiguities or redundancy. The 41 remaining qu estions were analyzed for repeat- ability, internal consistency and the cap acity to discriminate between patients with vertebral fractures and control s. Comparison with the SF-36 was performed within similar domains by condit ional logistic regression and by receiver operating characteristic (ROC) cu rves. The repeatability of QUALEFFO was good (kappa statistics 0.54-0.90) a nd 26 of 41 questions had a kappa score greater than or equal to 0.70. The internal consistency of the five domains was adequate, with Crohnbach alpha around 0.80. All except five questions discriminated significantly between patients and controls. The median scores of QUALEFFO were significantly hi gher in patients with vertebral fractures than in controls in all five doma in (p<0.001), which is consistent with decreased quality of life in patient s with osteoporosis. Spinal radiographs were assessed using the McCloskey-K anis algorithm. According to this, 124 patients (78%) had vertebral fractur es of greater than or equal to 3 SD severity, in contrast with 7 controls ( 4%). Significant correlations existed between scores of similar domains of QUALEFFO and the SF-36, especially for pain, physical function and mental f unction. All five domains within each questionnaire discriminated significa ntly between fracture cases and controls. The odds ratios for pain and soci al function were greater for QUALEFFO, while general health perception was more discriminating using the SF-36. The ROC curve analysis of QUALEFFO ind icated that all five domains were significantly predictive of vertebral fra ctures. When comparing similar domains of the two questionnaires, QUALEFFO domains demonstrated significantly better performance for pain, physical fu nction and social function. The QUALEFFO total score and SF-36 physical com posite score showed similar performance. In conclusion, QUALEFFO is repeata ble, coherent and discriminates well between patients with Vertebral fractu res and control subjects. The results of this study confirm the decreased q uality of life in patients with vertebral fractures.