Journal article
Electronic Neurostatus-EDSS increases the quality of expanded disability status scale assessments: Experience from two phase 3 clinical trials.
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D'Souza M
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland/NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany.
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Heikkilä A
CRF Bracket, Helsinki, Finland.
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Lorscheider J
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland.
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Haller V
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland.
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Kravalis K
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland.
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Gysin S
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland.
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Fuertes NAC
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland.
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Fricker E
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland.
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Lam E
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
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Higgins P
CRF Bracket, Helsinki, Finland.
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Tomic D
Novartis Pharma AG, Basel, Switzerland.
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Papadopoulou A
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland/NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany.
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Kappos L
Neurology, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, Basel, Switzerland.
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Published in:
- Multiple sclerosis (Houndmills, Basingstoke, England). - 2020
English
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.
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Language
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Open access status
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closed
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Identifiers
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Persistent URL
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https://roar.hep-bejune.ch/global/documents/109635
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