Real world evidence in cardiovascular medicine: ensuring data validity in electronic health record-based studies.

Journal: Journal of the American Medical Informatics Association : JAMIA
Published Date: Nov 1, 2019

Abstract

OBJECTIVE: With growing availability of digital health data and technology, health-related studies are increasingly augmented or implemented using real world data (RWD). Recent federal initiatives promote the use of RWD to make clinical assertions that influence regulatory decision-making. Our objective was to determine whether traditional real world evidence (RWE) techniques in cardiovascular medicine achieve accuracy sufficient for credible clinical assertions, also known as "regulatory-grade" RWE.

Authors

  • Tina Hernandez-Boussard
    Stanford Center for Biomedical Informatics Research, Stanford, California 94305, USA.
  • Keri L Monda
    The Center for Observational Research and Medical Affairs, Amgen, Inc., Thousand Oaks, California, USA.
  • Blai Coll Crespo
    The Center for Observational Research and Medical Affairs, Amgen, Inc., Thousand Oaks, California, USA.
  • Dan Riskin
    Department of Medicine, Stanford University, Stanford, California, USA.

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