Harnessing Real-World Data to Inform Decision-Making: Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Ellen M Mowry - , Johns Hopkins University (Author)
  • Robert A Bermel - , Cleveland Clinic Ohio (Author)
  • James R Williams - , Biogen (Author)
  • Tammie L S Benzinger - , Washington University St. Louis (Author)
  • Carl de Moor - , Biogen (Author)
  • Elizabeth Fisher - , Biogen (Author)
  • Carrie M Hersh - , Lou Ruvo Center for Brain Health (LRCBH) (Author)
  • Megan H Hyland - , University of Rochester (Author)
  • Izlem Izbudak - , Johns Hopkins University (Author)
  • Stephen E Jones - , Cleveland Clinic Ohio (Author)
  • Bernd C Kieseier - , Biogen (Author)
  • Hagen H Kitzler - , Institute and Polyclinic of Diagnostic and Interventional Neuroradiology, Center of Clinical Neuroscience, University Hospital Carl Gustav Carus Dresden (Author)
  • Lauren Krupp - , New York University (Author)
  • Yvonne W Lui - , New York University (Author)
  • Xavier Montalban - , Vall d'Hebron University Hospital (Author)
  • Robert T Naismith - , Washington University St. Louis (Author)
  • Jacqueline A Nicholas - , Riverside Methodist Hospital (Author)
  • Fabio Pellegrini - , Biogen (Author)
  • Alex Rovira - , Vall d'Hebron University Hospital (Author)
  • Maximilian Schulze - , University Hospital Gießen and Marburg (Author)
  • Björn Tackenberg - , University Hospital Gießen and Marburg (Author)
  • Mar Tintore - , Vall d'Hebron University Hospital (Author)
  • Madalina E Tivarus - , University of Rochester (Author)
  • Tjalf Ziemssen - , Department of Neurology, Center of Clinical Neuroscience, University Hospital Carl Gustav Carus Dresden (Author)
  • Richard A Rudick - , Biogen (Author)

Abstract

Background: Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) is the first example of a learning health system in multiple sclerosis (MS). This paper describes the initial implementation of MS PATHS and initial patient characteristics. Methods: MS PATHS is an ongoing initiative conducted in 10 healthcare institutions in three countries, each contributing standardized information acquired during routine care. Institutional participation required the following: active MS patient census of ≥500, at least one Siemens 3T magnetic resonance imaging scanner, and willingness to standardize patient assessments, share standardized data for research, and offer universal enrolment to capture a representative sample. The eligible participants have diagnosis of MS, including clinically isolated syndrome, and consent for sharing pseudonymized data for research. MS PATHS incorporates a self-administered patient assessment tool, the Multiple Sclerosis Performance Test, to collect a structured history, patient-reported outcomes, and quantitative testing of cognition, vision, dexterity, and walking speed. Brain magnetic resonance imaging is acquired using standardized acquisition sequences on Siemens 3T scanners. Quantitative measures of brain volume and lesion load are obtained. Using a separate consent, the patients contribute DNA, RNA, and serum for future research. The clinicians retain complete autonomy in using MS PATHS data in patient care. A shared governance model ensures transparent data and sample access for research. Results: As of August 5, 2019, MS PATHS enrolment included participants (n = 16,568) with broad ranges of disease subtypes, duration, and severity. Overall, 14,643 (88.4%) participants contributed data at one or more time points. The average patient contributed 15.6 person-months of follow-up (95% CI: 15.5-15.8); overall, 166,158 person-months of follow-up have been accumulated. Those with relapsing-remitting MS demonstrated more demographic heterogeneity than the participants in six randomized phase 3 MS treatment trials. Across sites, a significant variation was observed in the follow-up frequency and the patterns of disease-modifying therapy use. Conclusions: Through digital health technology, it is feasible to collect standardized, quantitative, and interpretable data from each patient in busy MS practices, facilitating the merger of research and patient care. This approach holds promise for data-driven clinical decisions and accelerated systematic learning.

Details

Original languageEnglish
Pages (from-to)632
JournalFrontiers in neurology
Volume11
Publication statusPublished - 2020
Peer-reviewedYes

External IDs

PubMedCentral PMC7426489
Scopus 85087315620
ORCID /0000-0001-8799-8202/work/171553600

Keywords

Sustainable Development Goals