Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Evanston, IL, USA.
PCOM Analytics, Avallon, France.
J Patient Rep Outcomes. 2024 Aug 12;8(1):92. doi: 10.1186/s41687-024-00769-x.
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.
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.
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).
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.
ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic.
gov/ct2/show/NCT03928704 .
Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic.
gov/ct2/show/NCT03928743 .
疲劳是大多数中轴型脊柱关节炎（axSpA）患者的重要症状。FACIT-Fatigue 是一种 13 项患者报告结局（PRO）量表，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，FACIT-Fatigue 在整个 axSpA 谱中（包括非放射学 axSpA（nr-axSpA）和放射学 axSpA（r-axSpA））的心理测量特性并未得到充分评估。本研究旨在：（1）确定 FACIT-Fatigue 在 nr-axSpA、r-axSpA 和广泛的 axSpA 人群中的心理测量特性；（2）代表有意义的患者内变化（MWPC）、有意义的组间差异和横断面严重程度的 FACIT-Fatigue 评分。
对来自成人 nr-axSpA（BE MOBILE 1；N=254）和 r-axSpA（BE MOBILE 2；N=332）的两项 3 期试验的数据进行了合并分析和单独分析，以评估 FACIT-Fatigue 的心理测量特性。使用基于锚定和基于分布的方法得出 MWPC 和有意义的组间差异估计值。使用逻辑回归分析估计横断面疲劳严重程度的严重程度。
FACIT-Fatigue 表现出良好的内部一致性、足够的收敛性和已知群体的有效性，并且在整个 axSpA 谱中随着时间的推移对变化敏感。FACIT-Fatigue 评分增加 5-11 分估计代表 MWPC，选择 8 分增加作为应答者定义。FACIT-Fatigue 评分在 16 周期间变化 2.14-5.34 分估计代表小到中等有意义的组间差异。FACIT-Fatigue 评分严重程度定义为：无或轻微（>40）、轻度（>30 至≤40）、中度（>21 至≤30）和重度（≤21）。
这些发现支持将 FACIT-Fatigue 用作评估 axSpA 临床试验中与疲劳相关的治疗益处的合适工具。拟议的评分估计值和阈值可以指导整个 axSpA 谱中 FACIT-Fatigue 评分的解释。
ClinicalTrials.Gov，NCT03928704。2019 年 4 月 26 日注册-回顾性注册，https://classic.
gov/ct2/show/NCT03928704。
Gov，NCT03928743。2019 年 4 月 26 日注册-回顾性注册，https://classic.
gov/ct2/show/NCT03928743。
