Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: Multiple Sclerosis Journal
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
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,200
Funder: Novartis
OpenAlex ID: W4405655839