神经状态-智能护理临床试验：使医疗保健专业人员能够在多发性硬化症的分散式试验中评估扩展残疾状态量表。
Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis.
作者信息
Mallucci Giulia, Zimmer Andrea, Sfikas Nikolaos, Cerdá-Fuertes Nuria, Wunderlin Simon, Athanasopoulou Ioanna, Mroczek Magdalena, Phavanh Vanny, Sanak Lisa, Suter Jolanda, Friedli Bernadette, Kel Jakob, Trouillet Thomas, Simmen Sarah, Ocampo Alex, Wei Wenjia, Kieseier Bernd, Kamm Christian P, Kappos Ludwig, D'Souza Marcus
机构信息
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.
出版信息
Mult Scler. 2025 Apr;31(4):497-501. doi: 10.1177/13524585241305966. Epub 2024 Dec 20.
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.
背景
神经状态扩展残疾状态量表（EDSS）是用于评估多发性硬化症（MS）试验中损伤和残疾情况的标准测量工具，但需要训练有素的专家神经科医生来操作。
目的
本研究旨在评估经过专门培训的医护人员（HCPs）与经过标准化培训的神经科医生在神经状态-EDSS评估方面的一致性。
方法
一项针对100名MS患者的瑞士多中心、随机、交叉研究。HCPs接受了基于新开发的SMARTCARE-EDSS培训方法的神经状态-EDSS评估培训。
结果
HCPs与神经科医生之间的一致性率为0.87（95%置信区间（CI）=0.815-0.925）。
结论
经过培训的HCPs能够可靠地进行神经状态-EDSS评估，这有助于更广泛地开展评估工作并改善试验的可及性。
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