A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)

Authors

  • Jacqueline M. Cohen Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Centre for Fertility and Health, Norwegian Institute of Public Health
  • Carolyn E. Cesta Centre for Pharmacoepidemiology, Karolinska Institutet
  • Lars Kjerpeseth Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health
  • Maarit K. Leinonen Information Services Department, Finnish Institute for Health and Welfare
  • Óskar Hálfdánarson Centre for Public Health Sciences, University of Iceland
  • Øystein Karlstad Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health
  • Pär Karlsson Centre for Pharmacoepidemiology, Karolinska Institutet
  • Morten Andersen Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen
  • Kari Furu Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Centre for Fertility and Health, Norwegian Institute of Public Health
  • Vidar Hjellvik Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health

DOI:

https://doi.org/10.5324/nje.v29i1-2.4053

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).

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Published

2021-08-16

How to Cite

Cohen, J. M. ., Cesta, C. E. ., Kjerpeseth, L. ., Leinonen, M. K. ., Hálfdánarson, Óskar, Karlstad , Øystein ., Karlsson, P. ., Andersen, M. ., Furu, K., & Hjellvik, V. . (2021). A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS). Norsk Epidemiologi, 29(1-2). https://doi.org/10.5324/nje.v29i1-2.4053

Issue

Vol. 29 No. 1-2 (2021): Tema: Farmakoepidemiologi

Section

Articles

License

Copyright (c) 2021 Jacqueline M. Cohen

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