Psychometric validation of PROMIS-Fatigue-MS-8a and MSIS-29v2 questionnaires in relapsing multiple sclerosis participants enrolled in a phase 2 trial of frexalimab

IF 3 3区医学 Q2 CLINICAL NEUROLOGY

Multiple sclerosis and related disorders Pub Date : 2026-05-01 Epub Date: 2026-02-22 DOI:10.1016/j.msard.2026.107090

Patrick Vermersch , Lita Araujo , Samuel Gourlain , Natalia Hakimi-Hawken , Stephane Saubadu , Philippe Truffinet , Benoit Arnould , Jerome Msihid

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引用次数: 0

Abstract

Background

There are limited psychometric studies conducted using the Patient-Reported Outcomes Measurement Information System Adult Short Form-Fatigue-Multiple Sclerosis 8a (PROMIS-Fatigue-MS-8a) and Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29v2) questionnaires.

Methods

Data were collected from a phase 2 trial (NCT04879628) investigating frexalimab in adults with relapsing multiple sclerosis (RMS). Reliability, convergent validity, construct validity, and sensitivity to change were assessed on PROMIS-Fatigue-MS-8a and MSIS-29v2 using Cronbach’s alpha coefficient, intraclass correlation coefficient, Spearman’s or polyserial correlation coefficients, analysis of variance, and analysis of covariance, respectively. Analyses were conducted using baseline and Week 12 data from pooled treatment arms.

Results

Item-to-item correlations were acceptable (0.4–0.9) for most of the items for both patient-reported outcomes (PROs) at baseline and Week 12. Internal consistency was excellent (Cronbach’s alpha >0.90) for both PROs at baseline and Week 12. Additionally, good test–retest reliability was observed for PROMIS-Fatigue-MS-8a and the physical and psychological domains of MSIS-29v2. Convergent validity was supported by high correlations (r>0.50) between the PROMIS-Fatigue-MS-8a T-score and the MSIS-29v2 and the Patient Global Impression of Severity (PGIS)-Fatigue at baseline and Week 12. Construct validity was supported by significant differences between groups defined by the PGIS-Fatigue scores at baseline and Week 12 for both PROs (p<0.0001). Sensitivity to change was demonstrated by statistically significant differences in the mean change from baseline at Week 12 among groups defined by the PGIS-Fatigue and the Patient Global Impression of Change-Fatigue.

Conclusions

PROMIS-Fatigue-MS-8a and MSIS-29v2 are valid and reliable measures for evaluating treatment benefits in clinical trials of RMS.

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在参加frexalimab 2期试验的复发性多发性硬化症参与者中，对允诺-疲劳- ms -8a和MSIS-29v2问卷的心理测量学验证

背景：使用患者报告结果测量信息系统成人短表格疲劳-多发性硬化症8a（允诺-疲劳- ms -8a）和多发性硬化症影响量表-29第2版（MSIS-29v2）问卷进行了有限的心理测量研究。方法：数据收集自一项研究frexalimab治疗复发性多发性硬化症（RMS）成人的2期试验（NCT04879628）。采用Cronbach′s α系数、类内相关系数、Spearman′s或多序列相关系数、方差分析和协方差分析，分别对promisi -疲劳- ms -8a和MSIS-29v2的信度、收敛效度、结构效度和变化敏感性进行评估。使用合并治疗组的基线和第12周数据进行分析。结果：在基线和第12周，大多数项目的患者报告结果（PROs）的项目与项目之间的相关性是可接受的（0.4-0.9）。在基线和第12周，PROs的内部一致性都很好（Cronbach's alpha >0.90）。此外，promise - fatigue - ms -8a和MSIS-29v2的生理和心理领域具有良好的重测信度。在基线和第12周时，promisi -Fatigue- ms -8a t评分和MSIS-29v2与患者严重程度总体印象(PGIS)-疲劳之间的高相关性（r>0.50）支持了收敛效度。通过基线和第12周的pgis -疲劳评分来定义两组之间的显著差异，结构效度得到了支持。结论：在RMS临床试验中，允诺-疲劳- ms -8a和MSIS-29v2是评估治疗效果的有效和可靠的指标。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Multiple sclerosis and related disorders CLINICAL NEUROLOGY-

CiteScore

5.80

自引率

20.00%

发文量

814

审稿时长

66 days

期刊介绍： Multiple Sclerosis is an area of ever expanding research and escalating publications. Multiple Sclerosis and Related Disorders is a wide ranging international journal supported by key researchers from all neuroscience domains that focus on MS and associated disease of the central nervous system. The primary aim of this new journal is the rapid publication of high quality original research in the field. Important secondary aims will be timely updates and editorials on important scientific and clinical care advances, controversies in the field, and invited opinion articles from current thought leaders on topical issues. One section of the journal will focus on teaching, written to enhance the practice of community and academic neurologists involved in the care of MS patients. Summaries of key articles written for a lay audience will be provided as an on-line resource. A team of four chief editors is supported by leading section editors who will commission and appraise original and review articles concerning: clinical neurology, neuroimaging, neuropathology, neuroepidemiology, therapeutics, genetics / transcriptomics, experimental models, neuroimmunology, biomarkers, neuropsychology, neurorehabilitation, measurement scales, teaching, neuroethics and lay communication.