Periodic Reporting for period 5 - EHDEN (European Health Data and Evidence Network)
Berichtszeitraum: 2022-11-01 bis 2023-10-31
Presently, Europe is generating unprecedented amounts of patient-level information contained in Electronic Health Record (EHR) systems and other types of health databases. This includes structured data in the form of diagnoses, medication, laboratory test results, etc., and unstructured data in clinical narratives, all of which likely contain invaluable insights into the natural history and burden of disease. It is our ambition to fully leverage these vast volumes of data to improve clinical practice and individual patient outcomes by increasing our understanding of disease and treatment pathways and effects. We will galvanize transparent and reproducible analytics that will generate valid real-world evidence (RWE) to improve patient care and enable medical outcomes-based research at an unprecedented scale. The European Health Data and Evidence Network (EHDEN, ehden.eu) consortium is building the infrastructure and eco-system to make this ambition come true.
EHDEN’s has met all deliverables and outputs with little deviation from the DoA. The project’s activity has been focused in three main pillars. Key highlights in each have been:
• Open Calls:
o Seven Data Partner Calls held to date, with 187 Data Partners in 29 countries. By the end of year 5, ~70% of Data Partners mapped to the OMOP CDM.
o Four SME Calls held to date (no further calls planned), with 64 SMES selected in 22 countries, working with Data Partners at various stages of mapping to the OMOP common data model (CDM).
• Infrastructure:
o EHDEN Portal launched in June 2022, with free (moderated) access for researchers to explore the Data Partners and network dashboard (feasibility) of those mapped and included (N~130), with access by ~1100 users internationally by end of year 5.
o The Portal is being further developed with additional modules to support the study workflow and improve quality.
o EHDEN and OHDSI continue to collaborate (effectively symbiotic) with reference to open source tooling, skills and methods development.
• Research and Outcomes:
o Over the course of the project, six study-a-thons have been held by EHDEN in collaboration withOHDSI,PIONEER, andUMC, and UOXF. Several study-a-thons are planned to be conducted in year 6, including MegaStudy, that will include ~60 EHDEN Data Partners and additionally Data Partners from 8 EFPIA partners. . A manuscript on the study-a-thon methodology was published in November 2022. By the end of year 5, more than fifty project publications had been disseminated, which are all available via the Zenodo portal.
o An Evidence Generation Taskforce was created to have oversight of evidence generation and execution from year 4 onwards, and agreement within the Consortium and IMI on the creation of an Evidence Generation Fund to support expanded activity beyond the original DoA via our two Evidence Hubs at UOXF and EMC.
o As well as DoA use cases continuing in WP1, WP2 and WP3, a call for new research use cases was conducted early in year 4, and 4 were selected via the Evidence Generation Taskforce committee for inclusion into the study programme. In particular, the studies also supported engagement with Data Partners newly mapped to the OMOP CDM, and for future study-a-thons.
o Advances in Personalised Medicine, have been documented in videos via our YouTube site, highlighting work in explainable AI, methodological development and study design, natural language processing, and prediction and risk scores.
o A number of feasibility studies and studies proposed by third parties, including commercial, were supported by EHDEN, and coordinated network engagement via the EHDEN Community Manager and the PMO. This has served also as insightful for the future service development in sustainability post-IMI.
• Education and Community:
o The EHDEN Academy, launched in April 2020, has continued to flourish, with some ~4,500 enrolled by end of year 5, in nearly 100 countries worldwide, and with 19 courses launched across the tools, skills and methods spectrum, from mapping to the OMOP CDM, to working with mapped data for evidence generation. This work has also been in conjunction with the global OHDSI Education Group.
o EHDEN Academy is now collaborating with HDR UK Academy, Institute for Innovation through Health Data (i~HD) and the GetReal Institute Academy in areas of mutual interest, such as co-promotion.
o EHDEN Communications Team have continued to establish the project as a key stakeholder in this domain, particularly as the European setting sees development of the European Commission’s European Health Data Space programme. The project has also deepened its network via communications tools, such as a monthly blog and the Voice of EHDEN podcast that is now in its season 3. Diverse channels, includingEHDEN.eu and social networks, have been utilised to highlight our activity, and in particular to promote our bimonthly community calls with Data Partners and SMEs. EMA continued to promote EHDEN’s Data Partner calls to its distribution lists, such the ENCEPP Database.
o Via WP6 and a core team, value propositions have continued to be developed and expanded for a variety of stakeholders, but also the sustainability planning for post-IMI.
o A not-for-profit was incorporated in the Netherlands at the end of year 3, and the core team have further developed the sustainability plan and service thinking throughout year 5, with initial thinking around fundraising and configuration of the EHDEN Foundation
o The project has been very proactive in collaborating with the wider community with OHDSI, statutory bodies (Regulatory Authorities, Health Technology Assessment bodies, representative bodies, e.g. EFPIA, MedTech Europe, DIGITALEUROPE, et al.) and a myriad of other projects and programmes in IMI and Horizon Europe. Propagating the OMOP common data model by EHDEN has also been mirrored by wider organic adoption across countries, projects and programmes, inclusive of within IMI, further accelerating the harmonisation efforts in Europe.
o We have an ongoing collaboration with OHDSI to help strengthen both our communities. Additionally, OHDSI has helped us to promote the EHDEN academy via our leadership (Project Lead) of the OHDSI Education Working Group, working on the global education strategy.
• Open Calls:
o Seven Data Partner Calls held to date, with 187 Data Partners in 29 countries. By the end of year 5, ~70% of Data Partners mapped to the OMOP CDM.
o Four SME Calls held to date (no further calls planned), with 64 SMES selected in 22 countries, working with Data Partners at various stages of mapping to the OMOP common data model (CDM).
• Infrastructure:
o EHDEN Portal launched in June 2022, with free (moderated) access for researchers to explore the Data Partners and network dashboard (feasibility) of those mapped and included (N~130), with access by ~1100 users internationally by end of year 5.
o The Portal is being further developed with additional modules to support the study workflow and improve quality.
o EHDEN and OHDSI continue to collaborate (effectively symbiotic) with reference to open source tooling, skills and methods development.
• Research and Outcomes:
o Over the course of the project, six study-a-thons have been held by EHDEN in collaboration withOHDSI,PIONEER, andUMC, and UOXF. Several study-a-thons are planned to be conducted in year 6, including MegaStudy, that will include ~60 EHDEN Data Partners and additionally Data Partners from 8 EFPIA partners. . A manuscript on the study-a-thon methodology was published in November 2022. By the end of year 5, more than fifty project publications had been disseminated, which are all available via the Zenodo portal.
o An Evidence Generation Taskforce was created to have oversight of evidence generation and execution from year 4 onwards, and agreement within the Consortium and IMI on the creation of an Evidence Generation Fund to support expanded activity beyond the original DoA via our two Evidence Hubs at UOXF and EMC.
o As well as DoA use cases continuing in WP1, WP2 and WP3, a call for new research use cases was conducted early in year 4, and 4 were selected via the Evidence Generation Taskforce committee for inclusion into the study programme. In particular, the studies also supported engagement with Data Partners newly mapped to the OMOP CDM, and for future study-a-thons.
o Advances in Personalised Medicine, have been documented in videos via our YouTube site, highlighting work in explainable AI, methodological development and study design, natural language processing, and prediction and risk scores.
o A number of feasibility studies and studies proposed by third parties, including commercial, were supported by EHDEN, and coordinated network engagement via the EHDEN Community Manager and the PMO. This has served also as insightful for the future service development in sustainability post-IMI.
• Education and Community:
o The EHDEN Academy, launched in April 2020, has continued to flourish, with some ~4,500 enrolled by end of year 5, in nearly 100 countries worldwide, and with 19 courses launched across the tools, skills and methods spectrum, from mapping to the OMOP CDM, to working with mapped data for evidence generation. This work has also been in conjunction with the global OHDSI Education Group.
o EHDEN Academy is now collaborating with HDR UK Academy, Institute for Innovation through Health Data (i~HD) and the GetReal Institute Academy in areas of mutual interest, such as co-promotion.
o EHDEN Communications Team have continued to establish the project as a key stakeholder in this domain, particularly as the European setting sees development of the European Commission’s European Health Data Space programme. The project has also deepened its network via communications tools, such as a monthly blog and the Voice of EHDEN podcast that is now in its season 3. Diverse channels, includingEHDEN.eu and social networks, have been utilised to highlight our activity, and in particular to promote our bimonthly community calls with Data Partners and SMEs. EMA continued to promote EHDEN’s Data Partner calls to its distribution lists, such the ENCEPP Database.
o Via WP6 and a core team, value propositions have continued to be developed and expanded for a variety of stakeholders, but also the sustainability planning for post-IMI.
o A not-for-profit was incorporated in the Netherlands at the end of year 3, and the core team have further developed the sustainability plan and service thinking throughout year 5, with initial thinking around fundraising and configuration of the EHDEN Foundation
o The project has been very proactive in collaborating with the wider community with OHDSI, statutory bodies (Regulatory Authorities, Health Technology Assessment bodies, representative bodies, e.g. EFPIA, MedTech Europe, DIGITALEUROPE, et al.) and a myriad of other projects and programmes in IMI and Horizon Europe. Propagating the OMOP common data model by EHDEN has also been mirrored by wider organic adoption across countries, projects and programmes, inclusive of within IMI, further accelerating the harmonisation efforts in Europe.
o We have an ongoing collaboration with OHDSI to help strengthen both our communities. Additionally, OHDSI has helped us to promote the EHDEN academy via our leadership (Project Lead) of the OHDSI Education Working Group, working on the global education strategy.
Based on this fifth year’s activity and outputs, we are seeing completion of mapping to the CDM by ~70% of Data Partners mapped to the OMOP CDM by end of year 5. This mapping of Data Partners data is performed with certified SMEs, which together, will form the basis for the progenitor EHDEN network.
Year 5 has seen continued, remarkable progress of the project as it transitions into a start-up phase, preparing for longer term sustainability. We have already demonstrated that EHDEN is making a real difference in answering critical questions for clinicians, regulatory authorities, the wider research community and above all patients.
Year 5 has seen continued, remarkable progress of the project as it transitions into a start-up phase, preparing for longer term sustainability. We have already demonstrated that EHDEN is making a real difference in answering critical questions for clinicians, regulatory authorities, the wider research community and above all patients.