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

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...

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Main Authors: Jacqueline M. Cohen, Carolyn E. Cesta, Lars Kjerpeseth, Maarit K. Leinonen, Óskar Hálfdánarson, Øystein Karlstad, Pär Karlsson, Morten Andersen, Kari Furu, Vidar Hjellvik
Format: Article
Language:English
Published: Norsk Forening for Epidemiologi 2021-08-01
Series:Norsk Epidemiologi
Online Access:https://www.ntnu.no/ojs/index.php/norepid/article/view/4053
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spelling doaj-6897f1dfbeb14e80ae791dce5cc4b1a12021-08-23T13:55:00ZengNorsk Forening for EpidemiologiNorsk Epidemiologi0803-24912021-08-01291-210.5324/nje.v29i1-2.4053A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)Jacqueline M. Cohen0Carolyn E. Cesta1Lars Kjerpeseth2Maarit K. Leinonen3Óskar Hálfdánarson4Øystein Karlstad 5Pär Karlsson6Morten Andersen7Kari Furu8Vidar Hjellvik9Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Centre for Fertility and Health, Norwegian Institute of Public HealthCentre for Pharmacoepidemiology, Karolinska InstitutetDepartment of Chronic Diseases and Ageing, Norwegian Institute of Public HealthInformation Services Department, Finnish Institute for Health and WelfareCentre for Public Health Sciences, University of IcelandDepartment of Chronic Diseases and Ageing, Norwegian Institute of Public HealthCentre for Pharmacoepidemiology, Karolinska InstitutetPharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of CopenhagenDepartment of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Centre for Fertility and Health, Norwegian Institute of Public HealthDepartment of Chronic Diseases and Ageing, Norwegian Institute of Public Health 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). https://www.ntnu.no/ojs/index.php/norepid/article/view/4053
collection DOAJ
language English
format Article
sources DOAJ
author Jacqueline M. Cohen
Carolyn E. Cesta
Lars Kjerpeseth
Maarit K. Leinonen
Óskar Hálfdánarson
Øystein Karlstad
Pär Karlsson
Morten Andersen
Kari Furu
Vidar Hjellvik
spellingShingle Jacqueline M. Cohen
Carolyn E. Cesta
Lars Kjerpeseth
Maarit K. Leinonen
Óskar Hálfdánarson
Øystein Karlstad
Pär Karlsson
Morten Andersen
Kari Furu
Vidar Hjellvik
A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)
Norsk Epidemiologi
author_facet Jacqueline M. Cohen
Carolyn E. Cesta
Lars Kjerpeseth
Maarit K. Leinonen
Óskar Hálfdánarson
Øystein Karlstad
Pär Karlsson
Morten Andersen
Kari Furu
Vidar Hjellvik
author_sort Jacqueline M. Cohen
title A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)
title_short A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)
title_full A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)
title_fullStr A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)
title_full_unstemmed A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)
title_sort common data model for harmonization in the nordic pregnancy drug safety studies (norpress)
publisher Norsk Forening for Epidemiologi
series Norsk Epidemiologi
issn 0803-2491
publishDate 2021-08-01
description 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).
url https://www.ntnu.no/ojs/index.php/norepid/article/view/4053
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