Abstract
It is necessary to carry out large observational studies to generate robust evidence about the safety of drugs used during pregnancy. In the Nordic countries, nationwide population-based health registers that document all births and dispensed prescribed drugs are valuable resources for such studies. A common data model (CDM) is a data harmonization and structuring tool that enables a unified and streamlined analytic approach for studies including data from multiple countries or databases. We describe a CDM developed for the Nordic Pregnancy Drug Safety Studies (NorPreSS), including details on data sources and structure of the data tables. We also provide an overview of the advantages and disadvantages of the approach (e.g. sharing of data analysis programs versus extra initial work to create CDM datasets from raw data).
Highlights
Studies of drug safety in pregnancy typically involve both rare exposures and outcomes
We describe the common data model (CDM) approach to data harmonization that the Nordic Pregnancy Drug Safety Studies (NorPreSS) consortium, which started in 2017, carried out to facilitate studies based on data from five Nordic countries
In part III we describe how the NorPreSS CDM is designed and populated, by giving the structure of the various data tables
Summary
Studies of drug safety in pregnancy typically involve both rare exposures and outcomes. This necessitates conducting very large studies to generate robust evidence. International or multi-database studies that aim to have a single protocol and analytic approach must account for source data heterogeneity. We describe the common data model (CDM) approach to data harmonization that the Nordic Pregnancy Drug Safety Studies (NorPreSS) consortium, which started in 2017, carried out to facilitate studies based on data from five Nordic countries. In part II we describe the data sources used in NorPreSS. In part III we describe how the NorPreSS CDM is designed and populated, by giving the structure of the various data tables. In part IV we sum up with pros and cons of the CDM approach
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
