Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis.

Autor:	Mallucci G; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.; Neurocenter of Southern Switzerland, Regional Hospital of Lugano, Ente Ospedaliero Cantonale (EOC), Lugano, Switzerland., Zimmer A; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Sfikas N; Novartis Pharma AG, Basel, Switzerland., Cerdá-Fuertes N; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Wunderlin S; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Athanasopoulou I; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Mroczek M; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Phavanh V; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Sanak L; Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland., Suter J; Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland., Friedli B; Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland., Kel J; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Trouillet T; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Simmen S; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., Ocampo A; Novartis Pharma AG, Basel, Switzerland., Wei W; Novartis Pharma AG, Basel, Switzerland., Kieseier B; Novartis Pharma AG, Basel, Switzerland., Kamm CP; Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.; Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland., Kappos L; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland., D'Souza M; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.; Department of Neurology, University Hospital Basel, Basel, Switzerland.
Jazyk:	angličtina
Zdroj:	Multiple sclerosis (Houndmills, Basingstoke, England) [Mult Scler] 2024 Dec 20, pp. 13524585241305966. Date of Electronic Publication: 2024 Dec 20.
DOI:	10.1177/13524585241305966
Abstrakt:	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. Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: G.M. has nothing to declare. A.Z. has nothing to declare. N.S. is Novartis AG employee, Basel, Switzerland. N.C.-F. has nothing to declare. S.W. has nothing to declare. I.A. has nothing to declare. M.M. has nothing to declare. V.P. has nothing to declare. L.S. has nothing to declare. J.S. has nothing to declare. B.F. has nothing to declare. J.K. has nothing to declare. T.T. has nothing to declare. S.S. has nothing to declare. A.O. Novartis AG employee, Basel, Switzerland. W.W. is Novartis AG employee, Basel, Switzerland. B.K. is Novartis AG employee, Basel, Switzerland. C.P.K. has nothing to declare. L.K. has received no personal compensation. His institutions (University Hospital Basel/Foundation Clinical Neuroimmunology and Neuroscience Basel) have received and used exclusively for research support: payments for steering committee and advisory board participation, consultancy services, and participation in educational activities from: Actelion, Bayer, BMS, df-mp Molnia & Pohlmann, Celgene, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen, Japan Tobacco, Merck, MH Consulting, Minoryx, Novartis, F. Hoffmann-La Roche Ltd, Senda Biosciences Inc., Sanofi, Santhera, Shionogi BV, and TG. M.D.S. is an employee of the University Hospital Basel and the CEO of Neurostatus-UHB Ltd. He has received research support from the University Hospital Basel. F.D. has nothing to declare.
Databáze:	MEDLINE
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