Registry Working Party
ESID Registry - Newsletter December 2019
by Mikko Seppänen
As the year 2019 is closing in, it is time to share information on past and future activities of ESID Registry Working Party.
1. Updating ESID Registry
ESID Registry is the most valued asset of our society. It is also an essential tool for all PID doctors contributing to ESID. Not only are the numbers of known PIDs growing, so is ESID Registry. It represents the largest PID database in the world, with >30,000 PID patients. Our network is growing steadily, with more documenting centers having joined recently. Registry currently comprises >210 documenting centers across Europe and its neighboring areas. However, the numbers of documenting centers who have not recently updated their patient data is also increasing. This will in future seriously hamper the reliability of data, so we encourage all our documenting centers to increase their efforts.
2. ESID Registry growth
The number of ESID Registry publications is not following the pace with which the Registry is expanding. Some publications are from the national registries within ESID Registry platform. Consequently, there are now >50 PubMed-referenced ESID Registry-associated publications to date, with 4 in 2019. ESID Registry Steering Committee/Working Party (SC/WP) and ESID Board encourage you all to apply for and launch studies by using it!Gratifyingly, several completely new studies are now under planning and execution, after ESID Registry WP approval.
3. Collaboration with ERN RITA
ESID Board, ESID registry WP and European Reference Network on Rare Primary Immunodeficiency, Autoinflammatory and Autoimmune Diseases (ERN-RITA) are as part of European Commission-initiated Central Metadata Repository project ( https://eu-rd-platform.jrc.ec.europa.eu/erdri-description) collaboratively planning a common metaregistry on top of all existing international European Community registries on inborn errors of immunity. This would be able to collectively include all affected, registered patients from within Europe and European Community. Such a metaregistry would not replace ESID Registry and will only contain a very limited set of existing ESID Registry data fields but will aid towards better understanding of disease epidemiology and planning of larger studies. An application to fund such metaregistry has recently collaboratively been submitted.
4. Changes due to GDPR
Documenting of new patients has been slowed down or halted in many EU documenting centers due to the demands posed by EU General Data Protection Regulation (GDPR). We are currently, with the generous help of many of you, in the process of translating the patient consent forms into hopefully all languages represented by our documenting centers. Currently, we have these available in >10 different languages, while for example Czech, Polish, Slovak and Romanian language versions are under active progress. Translations will also need to be approved by a competent EC/IRB in that country. Translated patient consent forms and data protection supplements found from our website may be used as the basis, when applying for ongoing local EC/IRB permits, and in discussions with local data security officials. Some changes may be required by local ethics committees, depending on the local interpretation of GDPR. In case you are willing to help in this process, feel free to contact us at . Mainly versions in Baltic and Scandinavian languages, as well as in languages used south of the Mediterranean are still lacking.
We should also like to encourage all centres to inform the patients already registered at least with the ‘supplement to data protection’ about their rights resulting from the GDPR and respective contact information. The recommended procedure for this is outlined on the ESID website https://esid.org/Working-Parties/Registry-Working-Party/Informed-Patient-Consent.
Instructions how to handle the supplement to data protection
5. Advisory Council launch thus far frustratingly unsuccessful
Both Registry WP and ESID Board are concerned about how effective is our communication with the national (and large regional) PID Registries? We need to our valued members 1) a mechanism for feedback on proposed changes and 2) to update you on what may be planned, to enable frictionless and fruitful collaboration. We thus felt that important advice could be gained if National (or regional, if national does not yet exist and there are only large regional ones) Registries - from all countries participating in ESID - would appoint their chairs as national representatives to an ESID Registry Advisory Council under the Registry SG. The Council members would then receive e-mails and thus comment on any projected changes. These countries would not necessarily be restricted to EU. Thus, we want to remind you that all countries that have already joined or wish to join ESID Registry - and may legally and technically do so - are encouraged to appoint Advisory Council Members. When doing this, please contact and Catharina Schütz ( ).
With Season’s Greetings,
ESID Registry Working Party Chair
Head of ESID Online Registry Team