title: Neurostatus e-Scoring improves consistency of Expanded Disability Status Scale assessments: A proof of concept study.
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)).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
authors.forename: Marcus
authors.initials: M
authors.lastname: D'Souza
authors.affiliation: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
authors.forename: Özgür
authors.initials: Ö
authors.lastname: Yaldizli
authors.affiliation: Neurostatus Systems AG, Basel, Switzerland.
authors.forename: Roland
authors.initials: R
authors.lastname: John
authors.affiliation: Clinical Trial Unit, Department of Clinical Research, University Hospital of Basel, Basel, Switzerland.
authors.forename: Deborah R
authors.initials: DR
authors.lastname: Vogt
authors.affiliation: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
authors.forename: Athina
authors.initials: A
authors.lastname: Papadopoulou
authors.affiliation: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lucassen
authors.affiliation: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
authors.forename: Milena
authors.initials: M
authors.lastname: Menegola
authors.affiliation: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
authors.forename: Michaela
authors.initials: M
authors.lastname: Andelova
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Frank
authors.initials: F
authors.lastname: Dahlke
authors.affiliation: Neurostatus Systems AG, Basel, Switzerland.
authors.forename: Franz
authors.initials: F
authors.lastname: Schnyder
authors.affiliation: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D000075082:Proof of Concept Study; D015203:Reproducibility of Results; D016138:Walking / Q000706:statistics & numerical data; D055815:Young Adult
keywords: EDSS; Multiple sclerosis; clinical trial; disability; neurostatus