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  • Perspective
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Standardization and digitization of clinical data in multiple sclerosis

Nature Reviews Neurology volume 17, pages 119–125 (2021)Cite this article

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Abstract

Standardization is necessary to ensure the reliability of clinical data and to enable longitudinal and cross-sectional comparisons of data obtained in different centres and countries. In patients with multiple sclerosis (MS), standardized clinical data are needed for monitoring of disability and for collecting real-world evidence for use in research. This Perspective describes attempts to improve the standardization and digitization of clinical data in MS, including digital electronic health recording systems and applications that attempt to offer a comprehensive assessment of patients’ neurological deficits and their effects on daily life. Despite the challenges raised by regulatory, ethical and data-privacy considerations, the standardization and digitization of clinical data in MS is expected to generate new insights into the pathophysiology of the disease and to contribute to personalized patient care.

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Fig. 1: Neurostatus-eEDSS.
Fig. 2: Tools and initiatives for improving data standardization in multiple sclerosis.

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Acknowledgements

The authors thank T. Ziemssen for providing support in drafting the manuscript.

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Authors and Affiliations

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

    Marcus D’Souza, Athina Papadopoulou & Ludwig Kappos

  2. Research Center for Clinical Neuroimmunology and Neuroscience, University of Basel, Basel, Switzerland

    Marcus D’Souza, Athina Papadopoulou & Ludwig Kappos

  3. Office of the Chief Medical Informatics Officer, Digitalisierung & Information and Communication Technology Department, University Hospital Basel, Basel, Switzerland

    Marcus D’Souza

  4. Wega Informatik AG, Basel, Switzerland

    Christophe Girardey

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  4. Ludwig Kappos
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Contributions

M.D.S. researched data for the article and wrote the manuscript. A.P. researched data for the article and wrote parts of the manuscript regarding standardization in clinical routine care. C.G. researched data for the article and wrote parts of the manuscript regarding regulatory and ethical challenges. M.D.S., A.P. and L.K. additionally contributed substantially to discussions of the article content. All authors reviewed and edited the manuscript before submission.

Corresponding author

Correspondence to Marcus D’Souza.

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Competing interests

University Hospital Basel, the employer of M.D.S., A.P. and L.K., receives licence fees for Neurostatus products and uses these funds to support research. C.G. is an employee of Wega Informatik AG.

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Nature Reviews Neurology thanks L. Peeters and J. Sastre-Garriga for their contribution to the peer review of this work.

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Related links

Health Level Seven International (HL7) initiative: http://www.hl7.org

International Medical Device Regulators Forum: http://www.imdrf.org/about/about.asp

MSBase: https://www.msbase.org

MS BRIDGE: https://bridge.ucsf.edu

MS Data Alliance: https://msdataalliance.com/

ODHSI (Observational Health Data Sciences and Informatics) initiative: https://www.ohdsi.org

PROMS (Patient Reported Outcomes for MS) initiative: https://www.charcot-ms.org/initiatives/proms

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D’Souza, M., Papadopoulou, A., Girardey, C. et al. Standardization and digitization of clinical data in multiple sclerosis. Nat Rev Neurol 17, 119–125 (2021). https://doi.org/10.1038/s41582-020-00448-7

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