ERN-LUNG PRIME
Welcome to ERN-LUNG PRIME (Patient Registry for Improving Medical Excellence), generally known as the ERN-LUNG registry, is one of the two registries of European Reference Network-LUNG. It was designed and established by the Medical Informatics (Holger Storf and Jaanik Schaaf)-University Hospital Frankfurt am Main consortium, led by Thomas O.F. Wagner of University Hospital Frankfurt am Main, Germany, as part of the Registry Data Warehouse database that meets European requirements and standards, including General Data Protection Regulation (GDPR 2016/679).
As part of the European Reference Network for Rare Respiratory Diseases, ERN-LUNG PRIME is a vital element in an era when healthcare digitalization in Europe acts as a catalyst for information, research, analysis, and innovation. We follow the recommendations of the EU Expert Committee on Rare Diseases, which include international interoperability of registries and databases for pooling and exchanging rare illness knowledge and data. This Registry has been reviewed and approved under the number 20-950 by the Institutional Ethics Committee of the University Hospital Frankfurt am Main.
Objectives
REGISTRY OBJECTIVE
- Measure, survey, and compare distinct aspects of Rare Diseases manifestation, course and treatment, and especially to gather information on the quality of care and utilization of services within ERN-LUNG.
- Improve the quality of medical care provided to patients particularly in the diagnosis and standards of care.
- Harmonisation of data on respiratory patients across the EU to enable addressing key epidemiological, cohort composition, care quality and care resource questions.
- Make data collected in the ERN-LUNG registry available to researchers, public authorities, industry, and other stakeholders.
- Establish Lung registries ecosystem based on interoperability and FAIR principles that is supported by the European Rare Diseases Registry infrastructure, tools and services.
Inclusion criteria
ERN-LUNG PRIME recruits all subjects diagnosed during clinical care and/or treated  within its Network, i.e. these are patients with the diagnosis of a rare disease of the respiratory system (See Core Networks in ERN-Lung) after the patient has signed the informed consent form.  (ICF in other languages available). Patients who do not have a respiratory Rare Disease diagnosis may be eligible if they are undergoing work-up by any member of ERN-LUNG. These patients then will be registered as undiagnosed patients.
All these factors are reasons for greater patient involvement not just in registries but also to be informed about future research projects and Patient Reported Outcomes (PROs).
Frequently Asked Questions
Is ERN-Lung Registry safe?
The personal (identifying data, ID) data will not be transferred; from the ID a pseudonym will be generated. Only the person entering the data will be able to see both, ID and Pseudonym. At the end of the data entry session, the person entering the data, can print the list of ID and pseudonyms of this specific centre. This list should be stored in a safe place with restricted access.
Each authorised operator (one per HCP) can enter the data for the respiratory centre. A highly protected system will ensure data protection through the encryption of data. Identifying patient data are not collected in the Registry.
How will the data be entered?
The person entitled to enter the data will receive credentials to login to the database and enter data online. If your hospital or another registry you work with supports patient data export files, we will have to check feasibility (please, provide a sample excel or html file or get in contact).
Which data sets are entered?
Datasets from ERN-LUNG HCP are collected under the terms of an ERN-LUNG Data Sharing Agreement. The data collected for each patient aligns with the “Set of common data elements for Rare Diseases Registration” and includes only relevant healthcare-related information.
Can all patients be entered?
Members were asked to ensure that they register only those patients who meet the ERN-LUNG criteria, including individuals with rare respiratory system disorders and undiagnosed patients falling under ORPHA-616874. These undiagnosed patients should exhibit symptoms primarily related to the broader field of the respiratory system, and their inclusion should align with the scope of ERN-LUNG.
Is there reimbursement for the contributions of patient data to PRIME?
As part of the mandatory yearly data transfer to the ERN registry (PRIME) for all HCPs associated with the ERNs, we kindly wish to inform you that reimbursement will not be available. The initial reimbursement was ONLY for the first cycle of patient transfer to ERN-LUNG PRIME in 2023.
Can non-ERN-LUNG HCPs join?
The ERN-LUNG PRIME primarily focuses on 79 ERN-LUNG member HCPs and 10 Affiliated Partners and assisting these hospitals with ERN-LUNG Registry implementation and data transfer.
Contact
In case of questions, please contact Thazhone Stephy Varghese, the ERN-LUNG Registry Project Manager or an email to ERN-Lung Registry administrator.
For more details refer to the Information for ERN-LUNG patients
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