EpiCore - a common data model for pharmacoepidemiological studies in Denmark, Norway and Sweden

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Purpose: 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. Here, 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. 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, (iv) be useable in both collaborative and single site settings, and (v) include support for quality control procedures. Results: The EpiCore CDM comprise two mandatory administrative tables (person and observation), six optional event tables (diagnosis, procedure, encounter, drug, primcare and cancer) and three optional lookup tables (drug_info, organisation_info and prescriber_info). Each table, along with its columns and constraints is specified according to a CDM specification template. This facilitates easy customization while providing detailed documentation. Its use is supported by an R-package called EpiCoreAssistant, 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 the EpiCore CDM, a specification template and an R package that offers a simple framework for improved workflows, standardizations and collaboration, focused on Scandinavian pharmacoepidemiological studies and with relevance for a broad palette of register-based health care researchers.
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EpiCore - a common data model for pharmacoepidemiological studies in Denmark, Norway and Sweden | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL Pharmacoepidemiology and Drug Safety This is a preprint and has not been peer reviewed. Data may be preliminary. 5 March 2025 V1 Latest version Share on EpiCore - a common data model for pharmacoepidemiological studies in Denmark, Norway and Sweden Authors : Peter Bjødstrup Jensen 0000-0001-5435-9092 , Jacob Harbo Andersen , Martin Ernst , M. Olesen , Øystein Karlstad 0000-0003-1204-787X , Kari Furu 0000-0003-2245-0179 , Julia Eriksson , Karin Gembert , and Anton Pottegård 0000-0001-9314-5679 [email protected] Authors Info & Affiliations https://doi.org/10.22541/au.174118349.94671636/v1 Published Pharmacoepidemiology and Drug Safety Version of record Peer review timeline 402 views 198 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Purpose 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. Here, 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. 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, (iv) be useable in both collaborative and single site settings, and (v) include support for quality control procedures. Results The EpiCore CDM comprise two mandatory administrative tables (person and observation), six optional event tables (diagnosis, procedure, encounter, drug, primcare and cancer) and three optional lookup tables (drug_info, organisation_info and prescriber_info). Each table, along with its columns and constraints is specified according to a CDM specification template. This facilitates easy customization while providing detailed documentation. Its use is supported by an R-package called EpiCoreAssistant, 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 the EpiCore CDM, a specification template and an R package that offers a simple framework for improved workflows, standardizations and collaboration, focused on Scandinavian pharmacoepidemiological studies and with relevance for a broad palette of register-based health care researchers. Supplementary Material File (pds-25-0159-file001.docx) Download 401.16 KB Information & Authors Information Version history V1 Version 1 05 March 2025 Peer review timeline Published Pharmacoepidemiology and Drug Safety Version of Record 3 Nov 2025 Published Copyright This work is licensed under a Non Exclusive No Reuse License. Collection Pharmacoepidemiology and Drug Safety Keywords cdm pharmacoepidemiology Authors Affiliations Peter Bjødstrup Jensen 0000-0001-5435-9092 Syddansk Universitet Klinisk Farmakologi Farmaci og Miljomedicin View all articles by this author Jacob Harbo Andersen Syddansk Universitet Klinisk Farmakologi Farmaci og Miljomedicin View all articles by this author Martin Ernst Syddansk Universitet Klinisk Farmakologi Farmaci og Miljomedicin View all articles by this author M. Olesen Syddansk Universitet Klinisk Farmakologi Farmaci og Miljomedicin View all articles by this author Øystein Karlstad 0000-0003-1204-787X Folkehelseinstituttet View all articles by this author Kari Furu 0000-0003-2245-0179 Folkehelseinstituttet View all articles by this author Julia Eriksson Karolinska Institutet Institutionen for medicin Solna View all articles by this author Karin Gembert Karolinska Institutet Institutionen for medicin Solna View all articles by this author Anton Pottegård 0000-0001-9314-5679 [email protected] Syddansk Universitet Klinisk Farmakologi Farmaci og Miljomedicin View all articles by this author Metrics & Citations Metrics Article Usage 402 views 198 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Peter Bjødstrup Jensen, Jacob Harbo Andersen, Martin Ernst, et al. EpiCore - a common data model for pharmacoepidemiological studies in Denmark, Norway and Sweden. Authorea . 05 March 2025. 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