The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation.

IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES Journal of Patient-Reported Outcomes Pub Date : 2024-08-12 DOI:10.1186/s41687-024-00769-x

David Cella, Christine de la Loge, Fatoumata Fofana, Shien Guo, Alicia Ellis, Carmen Fleurinck, Ute Massow, Maxime Dougados, Victoria Navarro-Compán, Jessica A Walsh

{"title":"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation.","authors":"David Cella, Christine de la Loge, Fatoumata Fofana, Shien Guo, Alicia Ellis, Carmen Fleurinck, Ute Massow, Maxime Dougados, Victoria Navarro-Compán, Jessica A Walsh","doi":"10.1186/s41687-024-00769-x","DOIUrl":null,"url":null,"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.Trial registration: ClinicalTrials.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 .","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"92"},"PeriodicalIF":2.4000,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11319684/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Patient-Reported Outcomes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s41687-024-00769-x","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}

引用次数: 0

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.

Trial registration: ClinicalTrials.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 .

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

轴性脊柱关节炎患者慢性疾病治疗功能评估--疲劳（FACIT-疲劳）量表：心理测量学特性和具有临床意义的解释阈值。

背景：疲劳是大多数轴性脊柱关节炎（axSpA）患者的一个重要症状。FACIT-疲劳是一种由 13 个项目组成的患者报告结果（PRO）工具，已被用于 axSpA 临床试验，以测量疲劳的严重程度和对日常活动的影响。然而，FACIT-Fatigue 的心理测量特性尚未在包括非放射学轴索硬化症（nr-axSpA）和放射学轴索硬化症（r-axSpA）在内的整个轴索硬化症范围内得到充分评估。本研究确定了：(1) FACIT-Fatigue 在 nr-axSpA、r-axSpA 和广泛 axSpA 患者中的心理计量特性；(2) 代表有意义的患者内部变化 (MWPC)、有意义的组间差异和横断面严重程度带的 FACIT-Fatigue 分数：对来自两项 3 期试验的数据进行汇总分析，分别评估 FACIT-Fatigue 的心理测量特性，试验对象分别为患有 nr-axSpA （BE MOBILE 1；N = 254）和 r-axSpA （BE MOBILE 2；N = 332）的成人。采用基于锚和基于分布的方法得出了 MWPC 和有意义的组间差异估计值。采用逻辑回归分析估算了横截面疲劳严重程度分段：结果：FACIT-疲劳具有良好的内部一致性、足够的收敛性和已知组的有效性，并且对整个 axSpA 范围内随时间变化的敏感性很高。据估计，FACIT-疲劳评分增加 5-11 分代表一次 MWPC，增加 8 分被选为响应者定义。据估计，在 16 周的时间内，FACIT-疲劳评分变化 2.14-5.34 分的差异代表有意义的小到中等组间差异。FACIT-疲劳评分的严重程度带定义为：无或最低（>40）、轻度（>30至≤40）、中度（>21至≤30）和重度（≤21）：这些研究结果支持将 FACIT-Fatigue 作为一种合适的测量方法，用于评估 axSpA 临床试验中与疲劳相关的治疗获益。建议的评分估计值和阈值可指导整个 axSpA 范围内的 FACIT-Fatigue 评分解释：试验注册：ClinicalTrials.Gov，NCT03928704。2019年4月26日注册-回顾性注册，https://classic.Clinicaltrials：gov/ct2/show/NCT03928704 .Clinicaltrials：Gov，NCT03928743。注册时间为 2019 年 4 月 26 日-追溯注册，https://classic.Clinicaltrials: gov/ct2/show/NCT03928743 .

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊