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FATIGUE-PRO measure for SLE-related fatigue: A real-world study
Results from two cross-sectional, observational studies assessing the psychometric properties of the FATIGUE-PRO, a systemic lupus erythematosus (SLE)-specific patient-reported outcome (PRO) measure, in real-world clinical outpatient settings were published in Lupus Science & Medicine by Gordon et al. Patients with SLE were recruited in Birmingham, UK (n = 200), and Düsseldorf, Germany (n = 234).
Key data: In both cohorts, the FATIGUE-PRO demonstrated strong measurement properties across physical fatigue, mental and cognitive fatigue, and susceptibility to fatigue. Internal consistency was high (Cronbach's alpha, 0.91–0.97), as was reliability (Person Separation Index [PSI], 0.89–0.95). Moderate-to-high correlations were observed between FATIGUE-PRO scores and other PRO measures, including Lupus Quality of Life (LupusQoL), particularly in the fatigue (r = −0.69 to −0.83) and pain (r = −0.67 to −0.76) domains. Low correlations were observed with clinician-reported disease activity measures, including SLE Disease Activity Index-2000 (SLEDAI-2K; r = −0.03 to 0.13) and British Isles Lupus Assessment Group-2004 (BILAG-2004; r = 0.02–0.06).
Key learning: In this study, the FATIGUE-PRO demonstrated consistency and reliability in measuring PROs in patients with SLE, supporting its use as a reliable and valid PRO measure of fatigue in SLE. Future research is needed to assess longitudinal measurement properties, sensitivity to change, and performance across larger and more diverse patient populations.
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