In recent years, and much like we are witnessing across the rest of Europe, Italy has seen a significant surge in interest in OHDSI and the OMOP Common Data Model (CDM). As the R&D Manager at BIOMERIS, I've observed this trend across several hospitals and scientific organisations, including registries, as well as among various stakeholders interested in observational research.
As of June 2022, under the guidance of Professor Lucia Sacchi from the University of Pavia, we founded the Italian Node of OHDSI. The group's objectives include promoting OHDSI at a national level, mapping Italian medical terminologies to the OMOP CDM, releasing documents and procedures to facilitate and enhance OMOP projects, and promoting the first network studies among the partners involved in the node.
To date, more than fifty people from more than thirty organisations have participated in node activities. During this first eighteen months, the two main activities conducted by the group have been the definition of a DPIA (Data Protection Impact Assessment) template and the organisation of the first two federated studies.
The DPIA template we have created serves as the ideal starting point for Italian Data Partners interested in harmonising their data to the OMOP CDM. The development of this template actively involved various roles, including technology, security, and privacy experts, as well as researchers and Data Protection Officers from the hospitals involved in the node. The main challenge faced by this working group related to the dual nature of hospitals in Italy: Those that have research alongside clinical care as their primary mission and those that function primarily as healthcare centres. This distinction results in different legal bases for reusing data for observational purposes. Another challenge is how the GDPR has been implemented in Italy and some existing regulatory gaps, which our DPIA identified and addressed. After nearly a year of work, the document has just been pre-released to node members.
The OHDSI Italia node will also support the design of the first two federated studies involving its Data Partners. Specifically, the first study aims to provide an overview of the data currently in OMOP format across the national territory and testing the readiness of the participating centres to carry out the administrative and technical steps required for the execution of an OHDSI study. The second study involves the development of a predictive model for sepsis during hospitalisation. In this case, one centre will be used for training different predictive models, while the other centres will serve as external validators to select the one that is the most performant.
Both studies have their synopses and protocols ready and are currently undergoing review by the ethical committees of individual participants. We hope to present the first preliminary results of the two studies at the 2024 European OHDSI Symposium.
For any Italian stakeholders interested in joining the node or if you would like to have more information about our initiatives, please register as indicated at the bottom of the node’s page or contact us directly at firstname.lastname@example.org and email@example.com.