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European Health Data and Evidence Network

Periodic Reporting for period 1 - EHDEN (European Health Data and Evidence Network)

Reporting period: 2018-11-01 to 2019-10-31

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 to improve patient care and enable medical outcomes-based research at an unprecedented scale. The Electronic Health Data and Evidence Network (EHDEN, www.ehden.eu) consortium will provide the infrastructure and eco-system to make this ambition come true, supporting the disease-specific projects in the IMI Big Data for Better Outcomes (BD4BO, www.bd4bo.org) programme, academia, pharmaceutical and life sciences, regulatory and allied institutions. The project is implemented based on the following vision, and mission:

Vision Statement
The European Health Data & Evidence Network (EHDEN) aspires to be the trusted observational research ecosystem to enable better health decisions, outcomes and care.

Mission Statement
Our mission is to provide a new paradigm for the discovery and analysis of health data in Europe, by building a largescale, sustainable federated network of data sources standardized to a common data model.
The criticality of the issue and EHDEN’s mission is paramount to the future provision of healthcare in Europe, our ability to generate evidence that is impactful today, and not tomorrow, and in general accelerating the time to an answer without reducing the quality of evidence. For research and development, the ability to utilise labelled data for Discovery, Development and post-Authorisation, supportive of phenomic typing, machine learning, etc., is wholly dependent on the ability to interact with real world data.
EHDEN’s foundational first year 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.
o An initial, pilot call for Small/Medium Enterprises (SMEs) to be certified (11/28 selected) and Data Partner applicants (20/29 selected), with completion of certification of SMEs by EOY 2019, and sub-grant agreement with Data Partners in the same time interval. (See Deliverable 5.1 for the process and www.ehden.eu/ehden-finalises-sme-open-call-process and www.ehden.eu/results-of-the-first-ehden-open-call-for-data-partners for the pilot call results).

Infrastructure:
o Establishment of the EHDEN architecture, with advancement of the EHDEN Database Catalogue, data characterisation tools and dashboards (See Deliverables 4.1 and D4.2)
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, and advanced multiple analytical pipelines (See Deliverable 4.3)

Research and Outcomes:
o A first study-a-thon was held in December 2018, and resulted in an oral presentation, and media release, at EULAR 2019, followed by the publication of a manuscript in The Lancet Rheumatology (doi.org/10.1016/S2665-9913(19)30075-X) and a second manuscript submitted.
o Protocols for different use cases, e.g. Drug Utilisation, Drug Safety, HTA, have been developed and will be run on prior OMOP mapped data, prior to working with EHDEN mapped Data Partners
o Methodological research in patient-level prediction and risk stratified estimation has been presented at conferences and is being submitted for publication
o Initial evaluation of the ICHOM standards for inclusion into the OMOP common data model has commenced (See www.ichom.org for more information on the ICHOM standards)

Education and Community:
o The EHDEN Academy has been successfully supportive of the SME certification curriculum, effectively with user-testing by the selected SMEs, and will be launched publicly in early 2020. Once launched, the academy will be available via www.academy.ehden.eu.
o The OHDSI EU symposium was held in March 2019 linked significantly to EHDEN, especially with participating SMEs and potential applicant Data Partners (See www.ehden.eu/ohdsi-europe-symposium-the-journey-from-data-to-evidence/).
o EHDEN and OHDSI Communications teams are working together on convergent activity to ensure aligned messaging
o Value propositions have been developed for many key stakeholders and actors in this domain, with more to follow in year 2, and analysis of learning, especially with regards to sustainability of past and current projects/programmes has been initiated (See deliverable 6.2)
o EHDEN has communicated extensively via multiple channels, on and offline, inclusive of five webcasts, our website and social networks. The project has been presented at many conferences, and meetings.
o The Scientific and Ethics Advisory Boards were formulated with nominations and first calls to articulate future work (See deliverable 7.7)

A summary report which visualises all our achievements in year 1 can be found at www.ehden.eu/wp-content/uploads/2020/03/EHDEN_Report_Year1_External.pdf
EHDEN is conducting work that is unique, not just in Europe, but internationally. It has progressed the adoption of the OHDSI framework for open science, already contributing to the scientific literature, and working to socialise this with its project partners and key actors.

As an example, in project month 2 we performed a 5-day study-a-thon at Oxford University on the topic of Elective total knee replacement (TKR) which is a safe and cost-effective treatment for severe knee osteoarthritis (OA). We brought together 42 researchers, including clinical experts and data scientists. In this exciting week, we designed, implemented, and executed a multinational, multi-database cohort analysis using electronic medical records and claims data from the US and the UK. Through collaboration and by using the OHDSI tools and data sources already mapped to the OMOP-CDM, we were able to go from question to answer in just 5 days. The study-a-thons are perfect mechanism to train new users of the tools and create valuable prediction models for patient care at the same time (See www.youtube.com/watch?v=X5yuoJoL6xs and EHDEN Deliverable 3.1 for more information).

All milestones and deliverables have been met, with little deviation from the DoA, as outlined in 1.1.2.

Progress has been made commensurate with the DoA original plans, and seemingly beyond many expectations in the wider community for the first year of an IMI project. As such, the Consortium have no concerns about progress and meeting both immediate and final goals.
The 3 pillars in EHDEN
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