Giulia Mallucci, Andrea Zimmer, Nikolaos Sfikas, Nuria Cerdá-Fuertes, Simon Wunderlin, Ioanna Athanasopoulou, Magdalena Mroczek, Vanny Phavanh, Lisa Sanak, Jolanda Suter, Bernadette Friedli, Jakob Kel, Thomas Trouillet, Sarah Simmen, Alex Ocampo, Wenjia Wei, Bernd Kieseier, Christian P Kamm, Ludwig Kappos, Marcus D'Souza
{"title":"神经状态- smartcare临床试验：使医疗保健专业人员能够评估多发性硬化症分散试验中的EDSS。","authors":"Giulia Mallucci, Andrea Zimmer, Nikolaos Sfikas, Nuria Cerdá-Fuertes, Simon Wunderlin, Ioanna Athanasopoulou, Magdalena Mroczek, Vanny Phavanh, Lisa Sanak, Jolanda Suter, Bernadette Friedli, Jakob Kel, Thomas Trouillet, Sarah Simmen, Alex Ocampo, Wenjia Wei, Bernd Kieseier, Christian P Kamm, Ludwig Kappos, Marcus D'Souza","doi":"10.1177/13524585241305966","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Neurostatus-Expanded Disability Status Scale (EDSS) is the standard measure used to assess impairment and disability in multiple sclerosis (MS) trials but requires trained expert neurologists.</p><p><strong>Objectives: </strong>This study aims to evaluate the concordance of Neurostatus-EDSS assessments from specially trained health care professionals (HCPs) and standardized trained neurologists.</p><p><strong>Methods: </strong>A Swiss multicenter, randomized, cross-over study with 100 people with MS. HCPs were trained to assess the Neurostatus-EDSS based on the newly developed SMARTCARE-EDSS training method.</p><p><strong>Results: </strong>The concordance rate between HCPs and neurologists was 0.87 (95% confidence interval (CI) = 0.815-0.925).</p><p><strong>Conclusion: </strong>Trained HCPs can reliably perform Neurostatus-EDSS assessments, supporting broader implementation and improved trial access.</p>","PeriodicalId":18874,"journal":{"name":"Multiple Sclerosis Journal","volume":" ","pages":"497-501"},"PeriodicalIF":4.8000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956382/pdf/","citationCount":"0","resultStr":"{\"title\":\"Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis.\",\"authors\":\"Giulia Mallucci, Andrea Zimmer, Nikolaos Sfikas, Nuria Cerdá-Fuertes, Simon Wunderlin, Ioanna Athanasopoulou, Magdalena Mroczek, Vanny Phavanh, Lisa Sanak, Jolanda Suter, Bernadette Friedli, Jakob Kel, Thomas Trouillet, Sarah Simmen, Alex Ocampo, Wenjia Wei, Bernd Kieseier, Christian P Kamm, Ludwig Kappos, Marcus D'Souza\",\"doi\":\"10.1177/13524585241305966\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Neurostatus-Expanded Disability Status Scale (EDSS) is the standard measure used to assess impairment and disability in multiple sclerosis (MS) trials but requires trained expert neurologists.</p><p><strong>Objectives: </strong>This study aims to evaluate the concordance of Neurostatus-EDSS assessments from specially trained health care professionals (HCPs) and standardized trained neurologists.</p><p><strong>Methods: </strong>A Swiss multicenter, randomized, cross-over study with 100 people with MS. HCPs were trained to assess the Neurostatus-EDSS based on the newly developed SMARTCARE-EDSS training method.</p><p><strong>Results: </strong>The concordance rate between HCPs and neurologists was 0.87 (95% confidence interval (CI) = 0.815-0.925).</p><p><strong>Conclusion: </strong>Trained HCPs can reliably perform Neurostatus-EDSS assessments, supporting broader implementation and improved trial access.</p>\",\"PeriodicalId\":18874,\"journal\":{\"name\":\"Multiple Sclerosis Journal\",\"volume\":\" \",\"pages\":\"497-501\"},\"PeriodicalIF\":4.8000,\"publicationDate\":\"2025-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956382/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Multiple Sclerosis Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/13524585241305966\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/12/20 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multiple Sclerosis Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/13524585241305966","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/20 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis.
Background: Neurostatus-Expanded Disability Status Scale (EDSS) is the standard measure used to assess impairment and disability in multiple sclerosis (MS) trials but requires trained expert neurologists.
Objectives: This study aims to evaluate the concordance of Neurostatus-EDSS assessments from specially trained health care professionals (HCPs) and standardized trained neurologists.
Methods: A Swiss multicenter, randomized, cross-over study with 100 people with MS. HCPs were trained to assess the Neurostatus-EDSS based on the newly developed SMARTCARE-EDSS training method.
Results: The concordance rate between HCPs and neurologists was 0.87 (95% confidence interval (CI) = 0.815-0.925).
Conclusion: Trained HCPs can reliably perform Neurostatus-EDSS assessments, supporting broader implementation and improved trial access.
期刊介绍：
Multiple Sclerosis Journal is a peer-reviewed international journal that focuses on all aspects of multiple sclerosis, neuromyelitis optica and other related autoimmune diseases of the central nervous system.
The journal for your research in the following areas:
* __Biologic basis:__ pathology, myelin biology, pathophysiology of the blood/brain barrier, axo-glial pathobiology, remyelination, virology and microbiome, immunology, proteomics
* __Epidemology and genetics:__ genetics epigenetics, epidemiology
* __Clinical and Neuroimaging:__ clinical neurology, biomarkers, neuroimaging and clinical outcome measures
* __Therapeutics and rehabilitation:__ therapeutics, rehabilitation, psychology, neuroplasticity, neuroprotection, and systematic management
Print ISSN: 1352-4585
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