Heart-Core Registry: goals and specific objectives

The general objective of this project is to build the 1^st overarching registry of the ERN GUARD-Heart (the Heart-Core Registry), following the standards and tools provided by the European Platform on Rare Disease Registration (EU RD Platform). In the Heart-Core Registry, a minimal core dataset for new patients in the ongoing and future ERN GUARD-Heart condition-specific registries will be prospectively collected, including the Set of Common Data Elements for Rare Diseases Registration provided by the European Commission’s Joint Research Centre (JRC). Importantly, existing international standards will be used (i.e., coding systems, terminologies and ontologies). This will lead to improved semantic interoperability between the Heart-Core Registry and other rare disease registries, particularly those used and enhanced by the ERNs. The Heart-Core Registry will be registered on the European Directory of Registries of ERDRI (ERDRI.dor) and its metadata will be provided to the Central Metadata Repository of ERDRI (ERDRI.mdr). In addition, the Heart-Core Registry will signpost users to the detailed condition-specific ERN GUARD-Heart registries. These activities will render the data in the Heart-Core Registry more searchable and findable, and will increase its visibility and reusability for various stakeholders in rare disease community, including clinicians, researchers, patients, healthcare providing organizations, policy makers, pharmaceutical or device companies, and other ERNs. In particular, the Heart-Core Registry will serve as a key information system for the European Commission and assessment bodies for the evaluation, monitoring and assessment of the ERN GUARD-Heart as foreseen in the ERN implementing decision. Importantly, by establishing a central source of standardized data of patients with rare cardiac diseases and using available and harmonized tools for interoperability in rare disease registries, such as the EU RD Platform and JRC standards for semantic interoperability, a comprehensive and cost-effective approach for rare disease registration in the ERN GUARD-Heart will be developed.

The specific objectives of the Heart-Core Registry project are:

Objective 1. To set up the Heart-Core Registry management and coordination team.

To establish a governance structure and develop the different components of the project team with well-defined responsibilities and roles to facilitate the design of the Heart-Core Registry and its maintenance following implementation, i.e., project management team, steering committee, advisory panel, expert working groups, and registry evaluation body.

Objective 2. To achieve high level of semantic interoperability in the Heart-Core Registry

To identify, review and select standard datasets and terminologies to maximize the utility of the Heart-Core Registry, enable communication and meaningful comparisons of its data with data from other registries, and better effectiveness of registry information.

Objective 3. To guarantee the delivery of a fully operational registry with high-quality data.

To ensure that the Heart-Core Registry is implemented according to the planned activities and that high-quality data are collected.

Objective 4. To adopt a gold standard, transparent data protection practice.

To facilitate the protection and enhancement of the right to privacy of patients entered into the Heart-Core Registry and safeguard compliance with national and European data protection regulations.

Objective 5. To increase the visibility of the Heart-Core Registry to stakeholders through a global communication and dissemination strategy.