European Health Data and Evidence Network (EHDEN)
Europe is generating huge amounts of patient-level information contained in Electronic Health Record (EHR) systems and other types of health databases. These include structured data in the form of diagnoses, medications, laboratory test results, and unstructured data in clinical narratives. The Electronic Health Data in a European Network (EHDEN) Consortium leverages these vast volumes of data to improve future clinical practice and individual patient outcomes by increasing our understanding of disease and treatment pathways. EHDEN 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 EHDEN Consortium provides the infrastructure and eco-system supporting disease-specific projects in the IMI Big Data for Better Outcomes (BD4BO) programme. The core of EHDEN is the use of a common data model (OMOP-CDM), standardised outcome assessment (ICHOM), and transparent open-source analytics (OHDSI). The objective of the EHDEN consortium is to provide all the necessary services that enable a distributed European data network to perform fast, scalable and highly reproducible research, while respecting privacy regulations, local data provenance and governance. This will include services and tools to perform data standardization, analytical pipelines, tools to share study results, and tools for stakeholder engagement and training. The EHDEN Consortium combines active participation of stakeholder representatives with proven experience in: a) integrating different data types, methods and technologies to utilize diverse clinical datasets; b) platform development to make methods and datasets Findable, Accessible, Interoperable and Reusable (FAIR); and c) engaging a wide variety of stakeholders, including health technology assessment agencies, regulators and patients.
Associate Professor Peter Rijnbeek is the coordinator of the EHDEN project.
European COVID-19 Observational Research Exchange (ECORE)
In June 2020, EMA contracted the company IQVIA with a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients (press release). This project will include the identification of large national cohorts of COVID-19 patients and appropriate comparator groups, the development of a study protocol template for multinational studies as well as the establishment of a collaborative framework for researchers. The project will be carried out in collaboration with the European Health Data & Evidence Network (EHDEN) consortium, which was established under the Innovative Medicines Initiative and includes the Erasmus Medical Centre in Rotterdam and the University of Oxford as project lead and research coordinator, respectively.
The HDS team is involved in this project and provides expertise on the CDM and linkage with the EHDEN project.
Ranitidine Drug Utilisation Study
Ranitidine is a competitive and reversible inhibitor of the action of histamine, released by enterochromaffin-like (ECL) cells, at the histamine H2-receptors on parietal cells in the stomach. It is indicated for the management of peptic ulceration, Gastroesophageal Reflux Disease (GERD), reflux oesophagitis, Zollinger-Ellison syndrome, chronic episodic dyspepsia, peptic ulcer hemorrhage, prophylaxis of stress ulceration, Mendelsons syndrome, duodenal ulcers, benign gastric ulcers, post-operative ulcer, symptomatic relief of heart burn, dyspepsia (acid indigestion), hyperacidity, and prevention of symptoms associated with consuming food and drink. Ranitidine is available for oral and parenteral administration.
The EU authorities were notified of the results of a preliminary laboratory analysis of ranitidine showing the presence of N-Nitrosodimethylamine (NDMA). The results on a limited sample of products showed that for the majority of both ranitidine APIs and finished products, NDMA was above the acceptable intake established during the referral procedure under Article 31 of Directive 2001/83/EC for sartans with a tetrazole ring (considering the maximum daily dose authorised in the EU, and long-term use in a 50 kg adult). Following extensive validation of the analytical method, the presence of NDMA in ranitidine finished products was confirmed.
The objective of this project is to rapidly generate information about prescribing and use patterns of ranitidine-containing medicines in EU Member States that will inform on the population at risk of exposure to NDMA (or other nitrosamines) through use of ranitidine.
The HDS team is collaboration with the team of Katia Verhamme in this project.
An international cohort of OHDSI collaborators obtained a grant from the COVID-19 Therapeutics Accelerator to lead an effort to compare the effectiveness of treatments, including corticosteroids such as dexamethasone, under current evaluation for COVID-19 across an international observational data network. The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments.
Researchers from the University of Oxford, Columbia University, UCLA and Erasmus University Medical Center are leading this work through Project SCYLLA (SARS-Cov-2 Large-scale Longitudinal Analyses), one of the emerging efforts to come from OHDSI’s global work surrounding COVID-19 research.
The HDS Team is involved in the analyses of the data and is providing data from the IPCI database for this study.
The Observational Health Data Sciences and Informatics (or OHDSI, pronounced "Odyssey") program is a multi-stakeholder, interdisciplinary collaborative to bring out the value of health data through large-scale analytics. OHDSI aims to generate accurate, reproducible, and well-calibrated evidence and promote better health decisions and better care. All our solutions are open-source. OHDSI has established an global network of researchers and observational health databases with a central coordinating center housed at Columbia University, see www.ohdsi.org.
OHDSI Europe is led by the coordinating center at the Erasmus University Medical Center in Rotterdam. We like to build a strong European OHDSI community that actively contributes to the further extension of the OMOP-CDM and analytical tool development. The team has organized symposia at the Erasmus MC in 2018 and 2019.
Health Outcomes Observatory (H2O)
We have started an exciting journey to give European patients a bigger and more influential voice in their own individual health care decisions and treatments. We will do so by providing patients with digital tools which will allow them to measure their symptoms in a standardized manner, communicate with their physicians and other healthcare providers and align on the right course of action. In addition to empowering patients, the H2O project is designed to enable a value-based approach in healthcare systems, improving their sustainability by helping them optimize care delivery and the use of their resources around outcomes that matter to patients. The project will set up independent organisations – the observatories – in four European countries (Austria, Germany, the Netherlands and Spain), initially focused on diabetes, inflammatory bowel disease and oncology. These will provide integrated information on patient outcomes for patients and their healthcare providers for use in clinical care. H2O aims to eventually launch observatories throughout Europe, covering many more disease categories. H2O is funded by the Innovative Medicines Initiative (IMI).
The HDS group is participating in H2O in the tasks where the OMOP Common Data Model is involved and will bring in its expertise obtained in OHDSI and the EHDEN project.
EU Patient-Centric Clinical Trial Platforms (EU-PEARL)
EU-PEARL brings together patients, clinicians, industry, researchers and authorities to create an open and trusted environment for knowledge sharing and science-driven debate on innovative clinical trials. Extensive cooperation amongst all stakeholders to improve health outcomes for patients is the driving force behind EU-PEARL. EU-PEARL brings together patients, clinicians, industry, researchers and authorities to create an open and trusted environment for knowledge sharing and science-driven debate on innovative clinical trials. Extensive cooperation amongst all stakeholders to improve health outcomes for patients is the driving force behind EU-PEARL. EU-PEARL brings together patients, clinicians, industry, researchers and authorities to create an open and trusted environment for knowledge sharing and science-driven debate on innovative clinical trials. Extensive cooperation amongst all stakeholders to improve health outcomes for patients is the driving force behind EU-PEARL.
The HDS group is participating in all tasks related to the OMOP Common Data Model in the EU-PEARL project.