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

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 assessmen

SUBMITTER: Mallucci G 

PROVIDER: S-EPMC11956382 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature