Trial reportJournal of patient-reported outcomes2024
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation.
Trial report in Journal of patient-reported outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Who cites it
11 citing papers in PubMed.
- Trial
- Trial
- Effects of reformer pilates on pain, psychological factors, and sleep in chronic musculoskeletal pain: a randomized controlled trial.BMC psychology · 2025Trial
- Project HERO: a randomized trial of Tai Chi qigong versus intensity-matched exercise and usual care for fatigue in older male cancer survivors.BMC complementary medicine and therapies · 2025Trial
- A distinct gastrointestinal symptom profile characterizes clinically relevant fatigue in systemic sclerosis.Clinical rheumatology · 2026Article
- Post-stroke rehabilitation in inflammatory rheumatic diseases: outcome measures, digital tools, and patient education perspectives.Rheumatology international · 2026Review
- Fatigue in Middle-Aged and Older Adults with Axial Spondyloarthritis: A Sex-Stratified Case-Control Study.Journal of clinical medicine · 2026Article
- Disparities in fatigue levels and dietary habits between men and women with inflammatory bowel disease: a comparative analysis with a control cohort.European journal of nutrition · 2026Article
- The relationship between vitamin D receptor (VDR) genomic polymorphisms, disease activity, and functional ability in patients with psoriatic arthritis.Clinical rheumatology · 2025Article
- Real-World Multinational Survey of Chronic Inflammatory Demyelinating Polyneuropathy: Disease Characteristics and Therapeutic Landscape.Journal of the peripheral nervous system : JPNS · 2025Article
- Causes of Sleep Disturbance in Early ASAS Spondyloarthritis: A Retrospective Long-Term Experience.Journal of personalized medicine · 2025Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFatigue is an important symptom for most patients with axial spondyloarthritis (axSpA). The FACIT-Fatigue is a 13-item patient-reported outcome (PRO) instrument that has been used in axSpA clinical trials to measure fatigue severity and impact on daily activities. However, the psychometric properties of the FACIT-Fatigue are not fully evaluated across the entire spectrum of axSpA including non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). This study determined: (1) the psychometric properties of the FACIT-Fatigue in nr-axSpA, r-axSpA, and the broad axSpA population and (2) FACIT-Fatigue scores representing meaningful within-patient change (MWPC), meaningful between-group differences, and cross-sectional severity bands.
methodsData from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1; N = 254) and r-axSpA (BE MOBILE 2; N = 332) were analyzed pooled and separately to assess the psychometric properties of the FACIT-Fatigue. MWPC and meaningful between-group difference estimates were derived using anchor-based and distribution-based methods. Cross-sectional fatigue severity bands were estimated using logistic regression analysis.
resultsThe FACIT-Fatigue presented good internal consistency, adequate convergent and known-groups validity, and was sensitive to change over time across the full axSpA spectrum. A 5-11-point increase in FACIT-Fatigue score was estimated to represent a MWPC, with an 8-point increase selected as the responder definition. A 2.14-5.34-point difference in FACIT-Fatigue score change over a 16-week period was estimated to represent a small-to-medium meaningful between-group difference. FACIT-Fatigue score severity bands were defined as: none or minimal (>40), mild (>30 to ≤40), moderate (>21 to ≤30), and severe (≤21).
conclusionsThese findings support the use of the FACIT-Fatigue as a fit-for-purpose measure to assess fatigue-related treatment benefit in axSpA clinical trials. The proposed score estimates and thresholds can guide FACIT-Fatigue score interpretation across the full axSpA spectrum.
trial registrationClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic. CLINICALTRIALS: gov/ct2/show/NCT03928704 . CLINICALTRIALS: Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic. CLINICALTRIALS: gov/ct2/show/NCT03928743 .
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.