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

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.