Responsiveness of the SF-36 and the Health Assessment Questionnaire Disability Index in a Systemic Sclerosis Clinical Trial

摘要: OBJECTIVE: This study compares the responsiveness to change of Medical Outcomes Study Short Form Health Survey (SF-36), a measure health related quality life (HRQOL), and Assessment Questionnaire Disability Index (HAQ-DI), function instrument, in randomized clinical trial for treatment systemic sclerosis (SSc). METHODS: A phase 2/3, multicenter, prospective, placebo controlled was conducted evaluate human recombinant relaxin patients with diffuse SSc over 24 weeks. At baseline, subjects had stable, moderately severe, disease duration or = 20, serum creatinine 50%, % DLCO predicted > 40% were not receiving concomitant modifying therapies. Internal consistency reliability multi-item scales estimated using Cronbach9s alpha. Responsiveness SF-36 HAQ-DI computed between Weeks 0 24. Subjects classified as unchanged having meaningful 4 different external measures: Change (1) skin score 30%; (2) FVC 15%; (3) self-reported patient global assessment by visual analog scale (VAS) 20%; (4) physician VAS 20%. indices Cohen9s effect size criteria used assess magnitude change. RESULTS: total 239 participated this trial, 196 completing week trial. alpha ranged from 0.76 0.93 0.69 0.91 (good excellent). The larger overall (patient assessment) compared HAQ-DI, while measures (i.e., predicted) than SF-36. CONCLUSION: These data support inclusion both outcome future trials SSc.