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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
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  • Hui Xing Tan,
  • Desmond Teo,
  • Haroun Chahed,
  • Cynthia Sung,
  • Doreen Tan,
  • Pei San Ang,
  • Sreemanee Raaj Dorajoo
Hui Xing Tan
Health Sciences Authority
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Desmond Teo
Health Sciences Authority
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Haroun Chahed
Yale-NUS College
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Cynthia Sung
Health Sciences Authority
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Doreen Tan
Khoo Teck Puat Hospital
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Pei San Ang
Health Sciences Authority
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Sreemanee Raaj Dorajoo
Health Sciences Authority
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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.

Peer review status:UNDER REVIEW

15 Sep 2020Submitted to British Journal of Clinical Pharmacology
16 Sep 2020Assigned to Editor
16 Sep 2020Submission Checks Completed
23 Sep 2020Reviewer(s) Assigned