From 2008 to 2011 the European Commission funded the initial work of the European IPF network (eurIPFnet) within the Seventh Framework Programme. Since then the work has been continued on local funding through the members home institutions and support from industry sources.
With the end of the initial public funding cycle of eurIPFnet, eurIPFreg was perpetuated as a core element of the TransMIT Project Division of Registries and Biobanks in Pneumology. The eurIPFreg Steering Committee that has been governing the registry since 2009 remains in charge. This Committee is comprised of Prof. Bruno Crestani (Hopital Bichat, Paris, France), Prof. Andreas Günther (University of Giessen, Germany), Prof. Carlo Vancheri (University of Catania, Italy) and Prof. Athol Wells (Royal Brompton Hospital London, United Kingdom). Prof. Günther remains the Coordinator of the registry. This Steering Committee, together with the eurIPFreg Ethics Committee, governs the scientific work of the registry and biobank.
External site investigators can join the eurIPFreg by signing a "site investigator contract" that defines the rights and obligations adderallof site investigators as well as financial compensation for contribution. Site investigators have the ability to enter patient data, receive anonymised comparisions to matched no-anxiety-meds.netpatient groups from the registry and perfom data analysis on their data sets as well as apply for permission to perform studies with the entire data pool of eurIPFreg.
The group's work aims to foster research on Idiopathic Pulmonary Fibrosis (IPF), the most aggressive form of an Idiopathic Interstitial Pneumonia (IIP). Within the eurIPFreg we, the eurIPFreg steering committee and a growing number of external site investigators, aim to describe the natural course of IPF and other IIPs, to identify risk factors that are associated with the evolution of the disease and to sample biomaterials that may serve as underlying basis for translational research activities.
IPF and non-specific interstitial pneumonia (NSIP), as well as the other entities of IIPs (cryptogenic organizing pneumonia, COP; desquamative interstitial pneumonia, DIP; respiratory bronchiolitis interstitial lung disease, RB-ILD; lymphoid interstitial pneumonia, LIP; acute interstitial pneumonia, AIP) are frequently progressive, fibroproliferative diseases of unknown etiology, affecting the lung parenchyma. Patients with IPF have the most devastating prognosis within the group of IIPs, with a median survival rate of 2-3 years.
Structure of Data Collection
The European IPF registry is designed as an internet-based, pan-European registry linked to the European IPF biobank (eurIPFbank). The data protection concept of eurIPFreg, the patient’s consent form in the respective national language and the contracts between the data processing institute (Justus-Liebig University, Giessen, Germany) and physicians and scientists are conform with most recent data protection guidelines and have been approved by the Hessian Data Protection Commissioner and the Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V.(TMF). The software (Secutrial), basis of the registry, was developed by the German Parkinson Network and is FDA and EMEA audited and certified. To date, the national ethics review board of France and local institutional review boards in Germany, Italy, Austria, Spain, Czech Republic, Hungary and the UK have approved the European IPF registry.
Upon initial entry of a patient's information a pseudonym is created, which is then used as the identifier for subsequent data entry. Identifying data of the patient will be hosted at a different site (Ludwig Maximilians University Munich) and physically removed from the medical data set. Re-identification of a patient will only be possible under certain conditions and will require approval by the ethical committee of the eurIPFreg (for details see “Data protection concept of the eurIPFreg” in the download area).
To reach the highest data quality possible, regular quality controls are applied to assure that only patients with a verified IIP diagnosis such as IPF or NSIP remain in the main registry. Patients with other lung diseases can be entered as control groups. For these patients a much smaller data set is collected and data entry is performed on a separate data sheet. The submitting site investigator will be asked to perform follow-up examinations for each patient and enter the data into the registry longitudinally. If the patient deceases, the site investigator is asked to document this inthe registry, including the underlying reasons of death (if known).
Initial data entry requires the completion of a patient and a physician baseline questionnaire. For the patient questionnaire, which covers all relevant aspects of the patient’s history, complaints, co-morbidity and quality of life, two options for completion exist: a) all questions are answered online, b) the patient questionnaire is printed out as an e-paper, with each page labelled with the patient’s pseudonym. The print-out can then be filled out by hand and be sent to Giessen via regular mail. In Giessen the questionnaire will be scanned to transfer all data into the database.
Patient questionnaires are available in the respective member states' languages. Upon registration of site investigators from new countries, translations of all necessary documents will be provided in a timely manner.
The physician questionnaire is filled out online (primary language is English). The physician questionnaire contains questions pertaining to all relevant diagnostic and therapeutic measures. In addition to the physician questionnaire it is necessary to upload at least one HR-CT in DICOM format in order to support the diagnosis. During HR-CT upload the patient’s name will automatically be removed from the DICOM-header and it will be replaced by the patient’s pseudonym. Histological findings can also be helpful, especially if these findings are VATS-biopsies. We ask all site investigators to upload representative histologic pictures and, in case of VATS-biopsies, to ship H&E and trichrome stained slides (labeled with a specific Lab-ID) to Giessen.
Finally, apart from upload of HR-CTs and slides, we also ask for transfer of biological materials such as blood and tissue samples, bronchoalveolar lavages, condensates of air passages and exhalative samples to the centralized European IPF biobank located at the Justus-Liebig University in Giessen. For each specimen and for each time point of sampling, a unique Lab-ID will be created, with which the biomaterial is labeled.