A recent paper published by researchers involved in the ConcePTION project explores the complexities of health information collected in electronic databases, commonly used to study the safety and effectiveness of medicines. Understanding the diverse features of these data sources is crucial for researchers to reproduce studies and validate their results. Something that can help us fill the knowledge gap on medicine safety in pregnancy and breastfeeding.
“ConcePTION has been instrumental in the expansion of research like this, providing a foundation to explore and address the challenges and opportunities presented by the diversity of real-world data sources,” says Rosa Gini, co-lead of ConcePTION WP7 and Head of the Pharmacoepidemiology Unit of ARS Toscana, Italy.
Rosa Gini and her colleagues have published the first systematic exploration of approaches to describe the diversity across data sources generating Real World Evidence. Based on 91 documents analysed in the scoping review, they identify 9 dimensions to represent diversity across data sources: organization accessing the data source, data originator, prompt, inclusion of population, content, data dictionary, time span, healthcare system and culture, and data quality. The scoping review lays the groundwork for a framework to characterise data sources used to generate Real World Evidence. The dimensions are compatible with both the ConcePTION conceptual framework that was used to create the ConcePTION Common Data Model, and the ConcePTION metadata incorporated in the ConcePTION Data Catalogue.
“The ConcePTION pipeline is ready by design to embrace and profit from data diversity”, concludes Rosa Gini.
Gini R, Pajouheshnia R, Gardarsdottir H, Bennett D, Li L, Gulea C, et al. Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review. Pharmacoepidemiology and Drug Safety. 2024;33(5):e5787.
Related ConcePTION work
Thurin, N.H., Pajouheshnia, R., Roberto, G., Dodd C., Hyeraci, G., Bartolini, C., Paoletti, O., Nordeng, H., Wallach-Kildemoes, H., Ehrenstein, V., Dudukina, E., MacDonald, T., De Paoli, G., Loane, M., Damase-Michel, C., Beau, A-B., Droz-Perroteau, C., Lassalle, R., Bergman, J., … Gini, R. (2021). From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding. Clinical Pharmacology & Therapeutics, vol 2022:111(1), 321-331. DOI: 10.1002/cpt.2476
Dodd, C., Gini, R., Sturkenboom, M., Hoxhaj, V., Hollestelle, M., Thurin, N., Bartolini, C., Paoletti, O., Roberto, G., Cunnington, M., Georgiou, B., Nordeng, H., Loane, M., Leinonen, M., Ehrenstein, V., Damase-Michel, C., Beau, A.-B., van Kammen, J., Swart, K., … Pierini, A. (2020). Report on existing common data models and proposals for ConcePTION (D7.5). Zenodo. DOI: 10.5281/zenodo.5829417
Swertz, M., Hyde, E., de Andrade, F., Gini, R., Pajouheshnia, R., Sturkenboom, M., Cunnington, M., Holub, P., Dolk, H., Loane, M., Given, J., Lewis, D., Yates, L., van Puijenbroek, E., & te Winkel, B. (2021). Prototype of FAIR data catalogue – 2nd (D7.7). Zenodo. DOI: 10.5281/zenodo.5829438
Thayer, D., Menon, K. B., & Gini, R. (2021). Wiki page with description of tools and GITHUB repository (D7.11). Zenodo. DOI: 10.5281/zenodo.5829464