Introducing a core dataset for real-world data in multiple sclerosis registries and cohorts: Recommendations from a global task force-Reference-Cited by-同舟云学术

Introducing a core dataset for real-world data in multiple sclerosis registries and cohorts: Recommendations from a global task force

Published:2023-12-23 Issue: Volume: Page:
ISSN:1352-4585
Container-title:Multiple Sclerosis Journal
language:en
Short-container-title:Mult Scler

Author:

Parciak Tina¹²³,Geys Lotte¹²³,Helme Anne⁴,van der Mei Ingrid⁵,Hillert Jan⁶^ORCID,Schmidt Hollie⁷,Salter Amber⁸^ORCID,Zakaria Magd⁹,Middleton Rodden¹⁰^ORCID,Stahmann Alexander¹¹^ORCID,Dobay Pamela¹²,Hernandez Martinez-Lapiscina Elena¹³,Iaffaldano Pietro¹⁴^ORCID,Plueschke Kelly¹⁵,Rojas Juan I¹⁶,Sabidó Meritxell¹⁷,Magyari Melinda¹⁸,van der Walt Anneke¹⁹^ORCID,Arickx Francis²⁰,Comi Giancarlo²¹^ORCID,Peeters Liesbet M¹²³^ORCID

Affiliation:

1. University MS Center (UMSC), Hasselt-Pelt, Belgium

2. UHasselt, Biomedical Research Institute (BIOMED), Diepenbeek, Belgium

3. UHasselt, Data Science Institute (DSI), Diepenbeek, Belgium

4. Multiple Sclerosis International Federation, London, UK

5. Menzies Institute for Medical Research, University of Tasmania, The Australian MS longitudinal study (AMSLS), Hobart, TAS, Australia

6. Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

7. Accelerated Cure Project, iConquerMS People-Powered Research Network, Waltham, MA, USA

8. Section on Statistical Planning and Analysis, UT Southwestern Medical Center, NARCOMS Registry, COViMS Registry, Dallas, TX, USA

9. Department of Neurology, Ain Shams University, Cairo, Egypt

10. Population Data Science, Swansea University Medical School, Swansea, UK

11. German MS Register by the German MS Society, MS Research and Project Development gGmbH (MSFP), Hanover, Germany

12. Biogen, Baar, Switzerland

13. Office of Therapies for Neurological and Psychiatric Disorders (H-NEU), Human Medicines (H-Division), European Medicines Agency, Amsterdam, The Netherlands

14. Department of Translational Biomedicine and Neurosciences (DiBraiN), Università degli Studi di Bari Aldo Moro, Italian MS registry, Bari, Italy

15. Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands

16. Neurology Department, Hospital Universitario de CEMIC, RelevarEM, Buenos Aires, Argentina

17. Department of Epidemiology, Merck Healthcare KGaA, Darmstadt, Germany

18. Danish Multiple Sclerosis Registry and Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital – Rigshospitalet, Glostrup, Denmark

19. Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia

20. National Institute for Health and Disability Insurance, Brussels, Belgium

21. Department of Rehabilitation Neurosciences, Casa di Cura Igea, Milan, Italy

Abstract

Background: As of September 2022, there was no globally recommended set of core data elements for use in multiple sclerosis (MS) healthcare and research. As a result, data harmonisation across observational data sources and scientific collaboration is limited. Objectives: To define and agree upon a core dataset for real-world data (RWD) in MS from observational registries and cohorts. Methods: A three-phase process approach was conducted combining a landscaping exercise with dedicated discussions within a global multi-stakeholder task force consisting of 20 experts in the field of MS and its RWD to define the Core Dataset. Results: A core dataset for MS consisting of 44 variables in eight categories was translated into a data dictionary that has been published and disseminated for emerging and existing registries and cohorts to use. Categories include variables on demographics and comorbidities (patient-specific data), disease history, disease status, relapses, magnetic resonance imaging (MRI) and treatment data (disease-specific data). Conclusion: The MS Data Alliance Core Dataset guides emerging registries in their dataset definitions and speeds up and supports harmonisation across registries and initiatives. The straight-forward, time-efficient process using a dedicated global multi-stakeholder task force has proven to be effective to define a concise core dataset.

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

Link

http://journals.sagepub.com/doi/pdf/10.1177/13524585231216004

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