Transforming electronic medical records to a common data model for
real-world benefit-risk assessments in a tertiary care facility in
Singapore
Abstract
Aim: To assess the feasibility of converting electronic medical records
(EMR) into the Observational Medical Outcomes Partnership-Common Data
Model (OMOP-CDM) schema and potential for subsequent analyses relating
to drug safety. Methods: The EMRs belonging to a tertiary care facility
from 2013 to 2016 were mapped onto the OMOP-CDM schema. Vocabulary
mappings were applied to translate source data values into OMOP-CDM
terminologies. Existing analytic codes from a previous study were
modified and applied to conduct an illustrative analysis involving oral
anticoagulants (OACs) to mimic analyses that may be part of a typical
benefit-risk assessment. A novel visualization is proposed to represent
comparative efficacy, safety and utilization in one chart. Results:
Records of 245,561 unique patients were mapped onto the OMOP-CDM. The
CDM and analytic code templates simplified the data analysis for the
illustrative example. Of 132 patients identified, a majority were
warfarin users (76.5%), followed by rivaroxaban (19.7%) and apixaban
(3.8%). Following six months of follow up, differences in cumulative
incidence of bleeding and thromboembolic events were observable. The
proposed visualization may facilitate collective evaluation of
differences relating to utilization, efficacy and safety of drugs of
interest. Conclusion: OMOP-CDM conversion of RWD may be useful for
gleaning insights on comparative drug utilization, efficacy and safety
for risk-benefit assessments in post-market regulatory settings.