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

Mult Scler. 2025 Apr;31(4):497-501. doi: 10.1177/13524585241305966. Epub 2024 Dec 20.

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.

Keywords: EDSS; Multiple sclerosis; clinical trials; decentralized trials; health care professionals.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Cross-Over Studies
  • Disability Evaluation*
  • Female
  • Health Personnel*
  • Humans
  • Male
  • Middle Aged
  • Multiple Sclerosis* / diagnosis
  • Multiple Sclerosis* / physiopathology
  • Neurologists* / standards
  • Severity of Illness Index
  • Switzerland