Real world evidence in cardiovascular medicine: ensuring data validity in electronic health record-based studies.
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.
Author(s): Hernandez-Boussard, Tina, Monda, Keri L, Crespo, Blai Coll, Riskin, Dan
DOI: 10.1093/jamia/ocz119