Neurostatus e-Scoring improves consistency of Expanded Disability Status Scale assessments: A proof of concept study

Author:

D’Souza Marcus1,Yaldizli Özgür1,John Roland2,Vogt Deborah R3,Papadopoulou Athina1,Lucassen Elisabeth1,Menegola Milena1,Andelova Michaela1,Dahlke Frank4,Schnyder Franz2,Kappos Ludwig1

Affiliation:

1. Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland

2. Neurostatus Systems AG, Basel, Switzerland

3. Clinical Trial Unit, Department of Clinical Research, University Hospital of Basel, Basel, Switzerland

4. Novartis Pharma AG, Basel, Switzerland

Abstract

Background: To improve the consistency of standardized Expanded Disability Status Scale (EDSS) assessments, an electronic data capture tool and analysis tool was developed, Neurostatus e-Scoring (NESC). This tool allows real-time feedback by comparing entries with established scoring rules. Objective: To test whether using NESC reduces inconsistencies as compared to the paper-and-pencil version of the Expanded Disability Status Scale (pEDSS). Methods: In all, 100 multiple sclerosis (MS) patients were assessed in random order on the same day by pairs of neurologists, one using pEDSS and one NESC. We compared inter-rater reliability and frequency of inconsistencies in Neurostatus subscores, functional system (FS) scores, ambulation and EDSS steps. Results: Inconsistencies of any type were more likely to occur when using pEDSS (mean odds ratio (95% confidence interval (CI)) = 2.93 (1.62; 5.29)). This was also the case for FS score inconsistencies (2.54 (1.40; 4.61)) and more likely for patients in the lower EDSS range (⩽3.5 vs >3.5) (5.32 (1.19; 23.77)). Overall, inter-rater agreement for the assessed Neurostatus subscores was high (median and inter-quartile range = 0.84 (0.73, 0.81)). Conclusion: Our data provide class II evidence that the use of NESC increases consistency of standardized EDSS assessments, and may thus have the potential to decrease noise and increase power of MS clinical trials.

Publisher

SAGE Publications

Subject

Clinical Neurology,Neurology

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