Metadata concepts for advancing the use of digital health technologies in clinical research

Research output: Contribution to journalArticle

Authors

  • Reham Badawy
  • Farhan Hameed
  • Lauren Bataille
  • Kasper Claes
  • Suchi Saria
  • Jesse M. Cedarbaum
  • Diane Stephenson
  • Jon Neville
  • Walter Maetzler
  • Alberto J. Espay
  • Bastiaan r. Bloem
  • Tanya Simuni
  • Daniel R. Karlin

Colleges, School and Institutes

External organisations

  • Pfizer, Inc., Cambridge, MA, USA
  • Northeastern University, Boston, MA, USA
  • Pfizer, Inc., New York, NY, USA
  • The Michael J. Fox Foundation for Parkinson’s Research, New York, NY, USA
  • Massachusetts Institute of Technology, Cambridge, MA, USA
  • UCB Biopharma, Brussels, Belgium
  • Johns Hopkins University, Baltimore, MD, USA
  • Critical Path Institute, Tucson, AZ, USA
  • Clinical Data Interchange Standards Consortium, Austin, TX, USA
  • Christian Albrecht University, Kiel, Germany
  • University of Cincinnati, Cincinnati, OH, USA
  • Radboud University Medical Center, Nijmegen, The Netherlands
  • Tufts University School of Medicine, Boston, MA, USA
  • HealthMode, New York, NY, USA
  • Biogen, Cambridge, MA, USA

Abstract

Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual’s disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory acceptance. Metadata, i.e., data that accompany and describe the primary data, can be utilized to better understand the context of the sensor data and can assist in data management, data sharing, and subsequent data analysis. The need for data and metadata standards for digital health technologies has been raised in academic and industry research communities and has also been noted by regulatory authorities. Therefore, to address this unmet need, we here propose a metadata set that reflects regulatory guidelines and that can serve as a conceptual map to (1) inform researchers on the metadata they should collect in digital health studies, aiming to increase the interpretability and exchangeability of their data, and (2) direct standard development organizations on how to extend their existing standards to incorporate digital health technologies. The proposed metadata set is informed by existing standards pertaining to clinical trials and medical devices, in addition to existing schemas that have supported digital health technology studies. We illustrate this specifically in the context of Parkinson’s disease, as a model for a wide range of other chronic conditions for which remote monitoring would be useful in both care and science. We invite the scientific and clinical research communities to apply the proposed metadata set to ongoing and planned research. Where the proposed metadata fall short, we ask users to contribute to its ongoing revision so that an adequate degree of consensus can be maintained in a rapidly evolving technology landscape.

Details

Original languageEnglish
Pages (from-to)116-132
Number of pages17
JournalDigital Biomarkers
Volume3
Issue number3
Publication statusPublished - 7 Oct 2019

Keywords

  • Digital health technology, Sensors, Objective monitoring of motor symptoms, Metadata, Parkinson’s disease