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Abstract：
BACKGROUND: Fatigue 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.
METHODS: Data 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.
RESULTS: 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 5-11-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).
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic.
RESULTS: gov/ct2/show/NCT03928704 .
RESULTS: Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic.
RESULTS: gov/ct2/show/NCT03928743 .
METHODS: Data 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.
RESULTS: 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 5-11-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).
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic.
RESULTS: gov/ct2/show/NCT03928704 .
RESULTS: Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic.
RESULTS: gov/ct2/show/NCT03928743 .
摘要：
背景：疲劳是大多数轴性脊柱关节炎（axSpA）患者的重要症状。FACIT-疲劳是一种13项患者报告结果（PRO）仪器，已在axSpA临床试验中用于测量疲劳严重程度和对日常活动的影响。然而,在axSpA的整个范围内，包括非影像学axSpA（nr-axSpA）和影像学axSpA（r-axSpA），尚未完全评估FACIT-疲劳的心理测量特性。本研究确定：(1)nr-axSpA中FACIT-疲劳的心理测量特性，r-axSpA,以及广泛的axSpA人群和(2)FACIT-Furness评分，代表有意义的患者内部变化(MWPC)，有意义的组间差异，和横截面严重程度带。
方法：对两项针对nr-axSpA（BEMOBILE1；N=254）和r-axSpA（BEMOBILE2；N=332）成人的3期试验数据进行汇总分析，并分别评估FACIT-疲劳的心理测量特性。MWPC和有意义的组间差异估计是使用基于锚和基于分布的方法得出的。使用逻辑回归分析估计横截面疲劳严重程度带。
结果：FACIT-疲劳表现出良好的内部一致性，足够的收敛和已知组有效性，并且对整个axSpA光谱随时间的变化很敏感。FACIT-疲劳评分增加5-11点估计代表MWPC，选择增加8点作为响应者定义。在16周的时间内，FACIT-Furness评分变化的2.14-5.34点差异估计代表了两组之间有意义的差异。FACIT-疲劳评分严重程度带定义为：无或最小（>40），轻度(>30至≤40)，中等(>21至≤30)，严重（≤21）。
结论：这些发现支持在axSpA临床试验中使用FACIT-Furness作为评估疲劳相关治疗获益的符合目的的措施。所提出的分数估计值和阈值可以指导整个axSpA频谱上的FACIT-疲劳分数解释。
背景：临床试验。政府，NCT03928704。2019年4月26日注册-追溯注册，https://经典。
结果：gov/ct2/show/NCT03928704。
结果：政府，NCT03928743。2019年4月26日注册-追溯注册，https://经典。
结果：gov/ct2/show/NCT03928743。
方法：对两项针对nr-axSpA（BEMOBILE1；N=254）和r-axSpA（BEMOBILE2；N=332）成人的3期试验数据进行汇总分析，并分别评估FACIT-疲劳的心理测量特性。MWPC和有意义的组间差异估计是使用基于锚和基于分布的方法得出的。使用逻辑回归分析估计横截面疲劳严重程度带。
结果：FACIT-疲劳表现出良好的内部一致性，足够的收敛和已知组有效性，并且对整个axSpA光谱随时间的变化很敏感。FACIT-疲劳评分增加5-11点估计代表MWPC，选择增加8点作为响应者定义。在16周的时间内，FACIT-Furness评分变化的2.14-5.34点差异估计代表了两组之间有意义的差异。FACIT-疲劳评分严重程度带定义为：无或最小（>40），轻度(>30至≤40)，中等(>21至≤30)，严重（≤21）。
结论：这些发现支持在axSpA临床试验中使用FACIT-Furness作为评估疲劳相关治疗获益的符合目的的措施。所提出的分数估计值和阈值可以指导整个axSpA频谱上的FACIT-疲劳分数解释。
背景：临床试验。政府，NCT03928704。2019年4月26日注册-追溯注册，https://经典。
结果：gov/ct2/show/NCT03928704。
结果：政府，NCT03928743。2019年4月26日注册-追溯注册，https://经典。
结果：gov/ct2/show/NCT03928743。
