(A-215) EpiCore - a common data model for Scandinavian pharmacoepidemiological studies

Background: The use of Common data models (CDMs) is increasing, however, the complexity of many CDM frameworks constitute a barrier for their use. For many local and collaborative use cases, simpler CDMs can suffice.

Objectives: We propose the EpiCore CDM, a simple CDM framework for use in Scandinavian pharmacoepidemiological studies.

Methods: The EpiCore CDM was developed based on a set of guiding principles, in that it should (i) be accessible to users without needing advanced technical expertise or extensive infrastructure, (ii) accommodate the most common elements of typical data sources in the field and region, while allowing easy customization for specific use cases, (iii) prioritize syntactic harmonization of data and defer clinical concept mapping to the analytical phase , and (iv) be useable in both collaborative and single site settings, and (v) include support for quality control procedures.

Results: The CDM comprises two mandatory administrative tables (person and observation), four optional event tables (diagnosis, procedure, encounter, and drug) and two optional lookup tables (drug_info and organization). Each CDM table, along with its columns and constraints is specified according to a CDM specification template. This template facilitates easy customization while providing detailed documentation. It is included in an R-package called cdmAssistant, which also provides quality control tools for testing compliance of a CDM instance with the agreed CDM specification. A step by step description is presented, demonstrating the steps involved in a typical CDM-based collaborative pharmacoepidemiologic study.

Conclusions: We present a CDM, a specification template and an R package that offers a simple framework for improved workflows, standardizations and collaboration, relevant to a broad palette of register-based health care researchers.