Neurostatus e-Scoring Increases Quality of the Expanded Disability Status Scale (EDSS) Assessments: First Experience in a Phase 3 Clinical Trial with Siponimod in Secondary Progressive Multiple Sclerosis (P2.112)

Objective: To analyse initial experiences with Neurostatus e-Scoring (NESC) in a global multi-centre phase 3 study. Background: To improve consistency of the expanded disability status scale (EDSS), NESC was developed. This algorithm-based electronic data capture system, implemented on a tablet computer, allows real-time detection and feedback on inconsistencies in calculating Functional System (FS) scores, Ambulation scores (AS) and EDSS. If the assessing physician cannot resolve inconsistencies by using the built-in feedback function, assessments are submitted to an Expert-Neurologist who reviews assessments through a web-based data resolution system and provides recommendations, which can be accepted or rejected by the assessing physician. Methods: More than 10,000 EDSS assessments from 1,651 patients, spanning 5 to 7 visits per patient, were analysed from 2013 to 2015 for: frequency of real-time feedback usage, time for data capture on device, number of inconsistencies of FS, AS and EDSS calculation, query turnaround time, and number of queries released to sites. Results: Approximately 46[percnt] of all assessments were submitted to the data resolution system after the 1st feedback round, 54[percnt] used at least a 2nd feedback, 24[percnt] a 3rd and 13[percnt] used a 4th feedback. Less than 30 minutes were required for 73[percnt] of all examinations to be completed from initiation to submission. Inconsistencies in FS and AS were reduced from 22.4[percnt] to 9.1[percnt] of all assessments spanning 5 to 7 Query turnaround time was less than 5 days in 31[percnt], 5 to 20 days in 24[percnt] and 45[percnt] needed more than 20 days. Query release to site was reduced from 33[percnt] to 16[percnt] of all assessments spanning 5 to 7 visits. Conclusion: NESC increases quality of EDSS assessments based on feedback function and Expert-Neurologist review. NESC reduces number and turnaround time of queries. Data is provided electronically and can be used at any time for analysis. Disclosure: Dr. D9Souza has received research support from Bayer AG, Teva, and Genzyme as well as research support from the University of Basel. Dr. John has received personal compensation for activities with Neurostatus Systems AG as an employee. Dr. Rust has received support from Bayer AG. Dr. Micicunaite has nothing to disclose. Dr. Andelova has nothing to disclose. Dr. Lorscheider has received support from Biogen and Novartis. Dr. Gysin has received personal compensation for activities with Neurostatus Systems AG as an employee. Dr. Hunter has received personal compensation for activities with Novartis Pharma AG as an employee. Dr. Wallstroem has received personal compensation for activities with Novartis as an employee. Dr. Schnyder has received personal compensation for activities with Neurostatus Systems AG as an employee. Dr. Kappos9s institution (University Hospital Basel) has received royalty payments from Neurostatus Systems GmbH.