Electronic Neurostatus-EDSS increases the quality of expanded disability status scale assessments: Experience from two phase 3 clinical trials

Mult Scler. 2020 Jul;26(8):993-996. doi: 10.1177/1352458519845108. Epub 2019 May 7.

Abstract

Background: The Neurostatus-eEDSS is an electronic tool providing automated real-time feedback on inconsistencies of Neurostatus-EDSS calculations.

Objective: To analyze the performance of the Neurostatus-eEDSS in two multicenter phase 3 multiple sclerosis (MS) trials.

Methods: All assessments captured with the Neurostatus-eEDSS web service during a period of 2.5 years were analyzed.

Results: Of the total 10,789 assessments, 40.1% had inconsistencies after first entry, reduced to 22.1% due to the real-time feedback. The entire checking process resulted in a change of the expanded disability status scale (EDSS) score in 14.8% of the assessments.

Conclusion: The Neurostatus-eEDSS can increase consistency and reliability of EDSS assessments in clinical MS trials.

Keywords: Disability; EDSS; digital; neurostatus; trials.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Algorithms*
  • Diagnosis, Computer-Assisted*
  • Disease Progression*
  • Feedback*
  • Humans
  • Multiple Sclerosis / diagnosis*
  • Severity of Illness Index*