Does the Multiple Sclerosis Impact Scale-29 (MSIS-29) have the range to capture the experience of fully ambulatory multiple sclerosis patients? Learnings from the ASCLEPIOS studies.

IF 2.5 Q2 CLINICAL NEUROLOGY Multiple Sclerosis Journal - Experimental, Translational and Clinical Pub Date : 2023-09-28 eCollection Date: 2023-07-01 DOI:10.1177/20552173231201422
Antoine Regnault, Angely Loubert, Róisín Brennan, Juliette Meunier, Christel Naujoks, Stefan Cano, Nicholas Adlard
{"title":"Does the Multiple Sclerosis Impact Scale-29 (MSIS-29) have the range to capture the experience of fully ambulatory multiple sclerosis patients? Learnings from the ASCLEPIOS studies.","authors":"Antoine Regnault,&nbsp;Angely Loubert,&nbsp;Róisín Brennan,&nbsp;Juliette Meunier,&nbsp;Christel Naujoks,&nbsp;Stefan Cano,&nbsp;Nicholas Adlard","doi":"10.1177/20552173231201422","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Trials of disease-modifying therapies (DMTs) for multiple sclerosis (MS) often include patients with minimal disability. Patient-reported outcome instruments used in these trials have often not captured physical and psychological treatment effects concomitant with observed clinical benefits.</p><p><strong>Objective: </strong>To examine whether the Multiple Sclerosis Impact Scale-29 (MSIS-29) captures changes in the impact of MS in a sample of patients enrolled in the Phase 3 ASCLEPIOS studies (ofatumumab vs. teriflunomide).</p><p><strong>Methods: </strong>Measurement properties (i.e. item fit, reliability, and targeting) of the MSIS-29 were analyzed using Rasch measurement theory (RMT) in data from two phase 3 ofatumumab clinical trials including patients with relapsing-remitting or secondary progressive MS (<i>N</i> = 1882). Targeting of the MSIS-29 items to the patient population was explored within groups categorized by Expanded Disability Status Scale (EDSS) scores.</p><p><strong>Results: </strong>Under RMT analyses, both the Physical and Psychological Impact scales of the MSIS-29 were not appropriately targeted to the overall sample of patients. In particular, 49% and 30% of patients with an EDSS score ≤ 2.5 had fewer physical and psychological impacts, respectively, than would typically be captured by these MSIS-29 items compared to patients with EDSS scores of ≥ 3.</p><p><strong>Conclusion: </strong>The MSIS-29 is commonly used to evaluate the patient-reported physical and psychological impact of MS. However, it may be limited in evaluating changes associated with DMTs in patients with minimal disability.</p>","PeriodicalId":18961,"journal":{"name":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","volume":"9 3","pages":"20552173231201422"},"PeriodicalIF":2.5000,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0f/96/10.1177_20552173231201422.PMC10540592.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/20552173231201422","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/7/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Trials of disease-modifying therapies (DMTs) for multiple sclerosis (MS) often include patients with minimal disability. Patient-reported outcome instruments used in these trials have often not captured physical and psychological treatment effects concomitant with observed clinical benefits.

Objective: To examine whether the Multiple Sclerosis Impact Scale-29 (MSIS-29) captures changes in the impact of MS in a sample of patients enrolled in the Phase 3 ASCLEPIOS studies (ofatumumab vs. teriflunomide).

Methods: Measurement properties (i.e. item fit, reliability, and targeting) of the MSIS-29 were analyzed using Rasch measurement theory (RMT) in data from two phase 3 ofatumumab clinical trials including patients with relapsing-remitting or secondary progressive MS (N = 1882). Targeting of the MSIS-29 items to the patient population was explored within groups categorized by Expanded Disability Status Scale (EDSS) scores.

Results: Under RMT analyses, both the Physical and Psychological Impact scales of the MSIS-29 were not appropriately targeted to the overall sample of patients. In particular, 49% and 30% of patients with an EDSS score ≤ 2.5 had fewer physical and psychological impacts, respectively, than would typically be captured by these MSIS-29 items compared to patients with EDSS scores of ≥ 3.

Conclusion: The MSIS-29 is commonly used to evaluate the patient-reported physical and psychological impact of MS. However, it may be limited in evaluating changes associated with DMTs in patients with minimal disability.

Abstract Image

Abstract Image

Abstract Image

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
多发性硬化症影响量表-29(MSIS-29)是否有足够的范围来捕捉完全卧床的多发性痴呆症患者的经验?ASCLEPIOS研究的经验教训。
背景:多发性硬化症(MS)的疾病改良疗法(DMTs)试验通常包括残疾程度最低的患者。这些试验中使用的患者报告的结果工具通常没有捕捉到伴随观察到的临床益处的身体和心理治疗效果。目的:研究多发性硬化症影响量表-29(MSIS-29)是否能反映参与ASCLEPIOS 3期研究(奥法单抗与特立氟胺)的患者样本中MS影响的变化包括复发-缓解或继发性进行性MS患者的试验(N = 1882)。在根据扩展残疾状态量表(EDSS)评分分类的组中,探讨了MSIS-29项目针对患者群体的目标。结果:根据RMT分析,MSIS-29的身体和心理影响量表均未适当针对患者的整体样本。特别是,与EDSS评分≥3的患者相比,EDSS评分≤2.5的患者中,分别有49%和30%的患者的身体和心理影响小于MSIS-29项目通常会捕捉到的影响。结论:MSIS-29通常用于评估患者报告的MS的身体和心理影响。然而,它在评估最小残疾患者DMTs相关变化方面可能受到限制。
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
CiteScore
4.70
自引率
0.00%
发文量
54
审稿时长
15 weeks
期刊最新文献
Cannabinoids for spasticity in patients with multiple sclerosis: A systematic review and meta-analysis. Treatment effect modifiers of immunotherapies for relapsing-remitting multiple sclerosis-A systematic review and meta-analysis. Cesarian sections in women with multiple sclerosis: A Canadian prospective pregnancy study. Exploring the relationship between neurologists and older persons with multiple sclerosis through the lens of social support theory. Illness representation in patients with multiple sclerosis: A preliminary narrative medicine study.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1