Summary
Objectives: The goal of this survey is to discuss the impact of the growing availability of electronic
health record (EHR) data on the evolving field of Clinical Research Informatics (CRI),
which is the union of biomedical research and informatics.
Results: Major challenges for the use of EHR-derived data for research include the lack of
standard methods for ensuring that data quality, completeness, and provenance are
sufficient to assess the appropriateness of its use for research. Areas that need
continued emphasis include methods for integrating data from heterogeneous sources,
guidelines (including explicit phenotype definitions) for using these data in both
pragmatic clinical trials and observational investigations, strong data governance
to better understand and control quality of enterprise data, and promotion of national
standards for representing and using clinical data.
Conclusions: The use of EHR data has become a priority in CRI. Awareness of underlying clinical
data collection processes will be essential in order to leverage these data for clinical
research and patient care, and will require multi-disciplinary teams representing
clinical research, informatics, and healthcare operations. Considerations for the
use of EHR data provide a starting point for practical applications and a CRI research
agenda, which will be facilitated by CRI’s key role in the infrastructure of a learning
healthcare system.
Keywords
Biomedical research - electronic health records - data collection - research design