Journal article
Neurostatus e-Scoring improves consistency of Expanded Disability Status Scale assessments: A proof of concept study.
- D'Souza M Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
- Yaldizli Ö Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
- John R Neurostatus Systems AG, Basel, Switzerland.
- Vogt DR Clinical Trial Unit, Department of Clinical Research, University Hospital of Basel, Basel, Switzerland.
- Papadopoulou A Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
- Lucassen E Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
- Menegola M Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
- Andelova M Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
- Dahlke F Novartis Pharma AG, Basel, Switzerland.
- Schnyder F Neurostatus Systems AG, Basel, Switzerland.
- Kappos L Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland.
- 2016-07-02
Published in:
- Multiple sclerosis (Houndmills, Basingstoke, England). - 2017
EDSS
Multiple sclerosis
clinical trial
disability
neurostatus
Adult
Aged
Clinical Trials as Topic
Disability Evaluation
Female
Humans
Male
Middle Aged
Multiple Sclerosis
Proof of Concept Study
Reproducibility of Results
Walking
Young Adult
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1177/1352458516657439
- PMID 27364325
- Persistent URL
- https://sonar.ch/global/documents/51197
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