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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Data from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1;\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009254) and r-axSpA (BE MOBILE 2;\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009332) 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The 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\u201311-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\u20135.34-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 (&gt;40), mild (&gt;30 to \u226440), moderate (&gt;21 to \u226430), and severe (\u226421).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019\u2014Retrospectively registered,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT03928704\">https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT03928704<\/jats:ext-link>\n                      . ClinicalTrials.Gov, NCT03928743. Registered 26 April 2019\u2014Retrospectively registered,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT03928743\">https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT03928743<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s41687-024-00769-x","type":"journal-article","created":{"date-parts":[[2024,8,12]],"date-time":"2024-08-12T05:03:22Z","timestamp":1723439002000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["The Functional Assessment of Chronic Illness Therapy\u2013Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation"],"prefix":"10.1186","volume":"8","author":[{"given":"David","family":"Cella","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"de la Loge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fatoumata","family":"Fofana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shien","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Ellis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Fleurinck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ute","family":"Massow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maxime","family":"Dougados","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Navarro-Comp\u00e1n","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica A.","family":"Walsh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,8,12]]},"reference":[{"key":"769_CR1","unstructured":"Arthritis Foundation (2022) The spondyloarthritis family. https:\/\/www.arthritis.org\/diseases\/spondyloarthritis. 21 Jun 2022"},{"key":"769_CR2","doi-asserted-by":"publisher","first-page":"663","DOI":"10.1016\/j.berh.2014.10.007","volume":"28","author":"N Garg","year":"2014","unstructured":"Garg N, Van Den Bosch F, Deodhar A (2014) The concept of spondyloarthritis: where are we now? 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All participants provided written informed consent in accordance with local requirements. Ethical approvals for BE MOBILE 1 and BE MOBILE 2 were obtained from the relevant institutional review boards or independent ethics committees at participating sites. Ethical approval for the qualitative study was obtained from Advarra Independent Review Board.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"DC is the president of FACIT.org. CdlL received consulting fees from UCB for this work. FF is an employee of Evidera PPD, a consultancy that received research funding from UCB Pharma to conduct this analysis. SG is an employee of Evidera PPD, a consultancy that received research funding from UCB Pharma to conduct this analysis. AE is an employee and shareholder of UCB Pharma. CF is an employee and shareholder of UCB Biopharma. UM is an employee and shareholder of UCB Pharma. MD declares competing interests from UCB (research grants received by his department and personal honorarium fees for participating at advisory boards), Novartis (research grants received by his department and personal honorarium fees for participating at advisory boards), Eli Lilly and Company (research grants received by his department and personal honorarium fees for participating at advisory boards), Pfizer (research grants received by his department and personal honorarium fees for participating at advisory boards), and AbbVie (research grants received by his department and personal honorarium fees for participating at advisory boards). VN-C is a speaker, consultant, and\/or instructor for AbbVie, Eli Lilly and Company, Galapagos, Janssen, Moonlake, Novartis, Pfizer, and UCB Pharma; and has received grant and\/or research support from AbbVie and Novartis. JAW declares competing interests from UCB, Novartis, Pfizer, Merck, AbbVie, Janssen, Amgen, and Sun Pharmaceutical.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"92"}}