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European Health Data and Evidence Network

Periodic Reporting for period 2 - EHDEN (European Health Data and Evidence Network)

Reporting period: 2019-11-01 to 2020-10-31

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, its clinical management and outcomes, and wider perspectives on both healthcare and the patient experience of it. 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 Processes and tools for the open calls have been developed and implemented and are being finetuned following each call.
o We now have 62 Data Partners across 16 countries (ehden.eu/datapartners) from our general open calls in 2019 and 2020, and the Coronavirus Disease 2019 (COVID-19) open call in May 2020 for specific representative clinical data to respond to the pandemic.
o Meanwhile, we also have 26 small and medium-sized enterprises (SMEs, ehden.eu/business-directory) selected, trained, and certified following two open calls in 2019 and 2020, respectively.
o The Data Selection Prioritisation Committee (DSPC) and SME Certification Committee (SMECC) has served calls to date and will be refreshed as per the DoA in year three.

• Infrastructure:
o Establishment of the EHDEN architecture, with continued advancement of the EHDEN Database Catalogue, data characterisation tools and dashboards, and we propose to launch these publicly in year three.
o EHDEN and OHDSI are effectively symbiotic with reference to open-source tooling and methods development. We made contributions to ETL and mapping tools, further developed the ARACHNE tool, integrated ELIXIR authentication mechanisms (delayed due to ELIXIR development timelines), and advanced multiple analytical pipelines. Both EHDEN and OHDSI collaborated considerably in addressing COVID-19 during 2020 with regards to a Data Partner call and collaboration on an international scale, as well as a COVID-19 study-a-thon (March) with ongoing collaboration via research protocols for characterising COVID-19 disease and presentation, as well as efficacy of anti-COVID-19 therapies, whether repurposed or de novo therapeutic agents.

• Research and Outcomes:
o A first study-a-thon in the domain of osteoarthritis and knee replacement was held in December 2018, and resulted in an oral presentation, and media release, at EULAR 2019, followed by the publication of manuscripts in The Lancet Rheumatology (all project publications are now available via the Zenodo EHDEN repository (zenodo.org/communities/ehden). A follow up study-a-thon in the domain of Rheumatoid Arthritis (RA) therapeutics was held in January 2020 and further publication outputs are forthcoming (impacted by the pandemic), while EHDEN collaborated within OHDSI on the COVID-19 study-a-thon in March and is continuing to do so via ongoing research protocols. EHDEN is also providing consultative support for a planned PIONEER study-a-thon (deferred to 2021)
o Protocols for different use cases, e.g. Drug Utilisation, Drug Safety, Health Technology Assessment (HTA), have been developed and are being run on prior OMOP mapped data, prior to working with EHDEN mapped Data Partners with their agreement in year three.
o Methodological research in patient-level prediction and risk stratified estimation has progressed significantly and research has been performed on explainable artificial intelligence (AI), Natural Language Processing (NLP). Etc.
o Initial evaluation of the ICHOM standards for inclusion into the OMOP common data model (CDM) was completed in year two, and expansion beyond this to generate machine readable standards and audit data via the CDM is being explored.

• Education and Community:
o The EHDEN Academy (www.academy.ehden.eu) has been successfully supportive of the SME certification curriculum, effectively with user-testing by the selected SMEs, and was launched publicly in April 2020. As of the date of reporting there are ~550 participant enrolees and nine courses across ETL, skills, tools, and methods in working with real world, observational data, with ongoing content expansion, promotion and collaboration work through the Academy.
o The OHDSI EU symposium was held in March 2019 linked significantly to EHDEN, especially with participating SMEs and potential applicant Data Partners, but was unfortunately cancelled in 2020 due to the pandemic. The symposium was commuted to a COVID-19 study-a-thon with ~290 participants across four continents in March 2020, leading to multiple publications and advisory engagements with EMA and the FDA (Cf. ehden.eu).
o EHDEN and OHDSI Communications teams are working together on convergent activity to ensure aligned messaging, while we have engaged with sister BD4BO projects, in particular HARMONY and PIONEER, as well as IMI, eh EU Commission and EMA in convergent communications activity for common goals. EMA is also promoting EHDEN’s Data Partner calls to its distribution lists, such the ENCEPP database.
o Value propositions (VPs) have been finalised for many key stakeholders and actors in this domain, incorporating into our engagement strategy in year two and beyond, and analysis of learnings, especially with regards to sustainability of past and current projects/programmes was initiated. We are engaging in more competitive landscaping as part of increased focus on sustainability in year three.
o EHDEN has communicated extensively via multiple channels, on and offline, inclusive of five webinars in year one, three webinars and three podcasts in year two (impacted by the pandemic), and our website and social media (Twitter, LinkedIn and YouTube). The project has been presented at numerous conferences, and meetings in reference to, and/or our scientific and technical outputs
o We have continued to consult our Scientific advisory board, whilst working on the development of a governance framework for EHDEN with our Ethics advisory board (initially publication and code(s) of conduct).
Based on these two years’ activity and outputs, we will see completion of mapping to the OMOP CDM in Year three for the majority of our 38 Data Partners from the first two calls, performed between them and certified SMEs (and an ETL Taskforce created specifically, and only, for the COVID-19 call), which will form the basis for the progenitor EHDEN network. We look forward to working together with Data Partners on use cases to validate and to verify the network approach in 2021, to evaluate the platform architecture, and meanwhile, continuing to expand our open calls to more Data Partners and SMEs.
The 3 pillars in EHDEN
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