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Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis

DOI: 10.1186/1477-7525-9-36

Keywords: Ankylosing spondylitis, Health-related quality of life, Physical and mental health, Reliability, Validity

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We analyzed clinical and patient-reported outcome (PRO) data collected during 12-week, double-blind, placebo-controlled periods of two randomized controlled trials comparing adalimumab and placebo for the treatment of active AS. The Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, and other clinical measures were collected during the clinical trial. We evaluated internal consistency/reliability, construct validity, and responsiveness to change for the SF-36 and FACIT-Fatigue.The SF-36 (Cronbach alpha, 0.74-0.92) and FACIT-Fatigue (Cronbach alpha, 0.82-0.86) both had good internal consistency/reliability. At baseline, SF-36 and FACIT-Fatigue scores correlated significantly with Ankylosing Spondylitis Quality of Life scores (r = -0.36 to -0.66 and r = -0.70, respectively; all p < 0.0001). SF-36 scores varied by indicators of clinical severity, with greater impairment observed for more severe degrees of clinical activity (all p < 0.0001). FACIT-Fatigue scores correlated significantly with SF-36 scores (r = 0.42 to 0.74; all p < 0.0001) and varied by clinical severity (p < 0.05 to p < 0.0001).The SF-36 is a reliable, valid, and responsive measure of health-related quality of life and the FACIT-Fatigue is a brief and psychometrically sound measure of the effects of fatigue on patients with AS. These PROs may be useful in evaluating effectiveness of new treatments for AS.ClinicalTrials.gov: NCT00085644 and NCT00195819Ankylosing spondylitis (AS) is a chronic and progressive inflammatory disorder that primarily affects the axial skeleton, sacroiliac joints of the pelvis, and thoracic cage [1,2]. Patients experience pain, joint stiffness, and the eventual loss of spinal mobility with disease progression. Patients with AS frequently experience impaired physical function and well-being, require time away from work because of disability, and suffer from diminished health-related quality of life (HRQOL) [3-7]. The impact of AS on

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