Clinical Outcome Measures Poster Presentation

P0052 - Completion rates by clinicians in global MS studies for the electronic EDSS compared to paper (ID 1904)

Speakers
  • J. Ly
Authors
  • J. Ly
  • R. Yamamoto
Presentation Number
P0052
Presentation Topic
Clinical Outcome Measures

Abstract

Background

The Expanded Disability Status Scale (EDSS) is a widely used assessment in multiple sclerosis (MS) clinical trials and often used as primary or secondary endpoints, contributing to labeling claims. However, inter- and intra-rater variability is high, which can lead to decreased power to detect treatment effects. Electronic implementations of the EDSS have been shown to reduce inconsistencies and improved inter-rater reliability. Yet, clinician acceptance of electronic implementations of the EDSS has rarely been examined.

Objectives

The aim of this study is to determine clinicians’ acceptance of the electronic EDSS by comparing the completion rates of the electronic version of the EDSS versus the pencil-and-paper version.

Methods

Data was collected as part of two phase 3, multicenter global MS trials during a 2-year period. All clinicians were provided ERT’s electronic EDSS, which uses the Neurostatus system of scoring algorithms and feedback including real-time, on-device detection of inconsistencies and post-submission guidance and queries on inconsistencies by expert reviewers. Clinicians had the option to complete the EDSS electronically in real-time or complete the assessment using the pencil-and-paper version prior to entering the scores on the electronic device.

Results

A total of 9142 assessments were completed with 2160 patients, from 357 sites, in 39 countries. 69.1% of the assessments were completed electronically in real-time and 30.8% were completed on paper first and transcribed onto the electronic device. 0.1% of the assessments were completed using neither the electronic nor paper version, but scores were entered electronically from clinicians’ recollection of the assessment. A majority of the sites used the electronic EDSS for more than 50% of their assessments. Sites in Thailand, Taiwan, Norway and Italy used the electronic EDSS for 100% of their assessments. Assessments using the electronic EDSS took an average of 82.1 minutes to complete. It took an average of 43.4 days for assessments completed on paper to be entered on the electronic device.

Conclusions

Overall, the use of the electronic EDSS was widely accepted by clinicians across the majority of the countries. This finding supports the use of an electronic EDSS to reduce inconsistencies, improve inter-rater reliability, and expedite the collection of data.

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