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Transforming electronic medical records to a common data model for real-world benefit-risk assessments in a tertiary care facility in Singapore

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.