Mortier, Philippe
Amigo, Franco
Bhargav, Madhav
Conde, Susana
Ferrer, Montse
Flygare, Oskar
Kizilaslan, Busenur
Latorre Moreno, Laura
Leis, Angela
Mayer, Miguel Angel
Pérez-Sola, Víctor
Portillo-Van Diest, Ana
Ramírez-Anguita, Juan Manuel
Sanz, Ferran
Vilagut, Gemma
Alonso, Jordi
Mehlum, Lars
Arensman, Ella
Bjureberg, Johan
Pastor, Manuel
Qin, Ping
Funding for this research was provided by:
Instituto de Salud Carlos III (ISCIII) and by the European Union NextGenerationEU, Mecanismo para la Recuperación y la Resiliencia (AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045, AC22/00006; AC22/00045)
ISCIII-FSE Miguel Servet co-funded by the European Social Fund Plus (ESF+; CP21/00078)
ISCIII and co-funded by the European Union (PI22/00107, PI22/00107, PI22/00107)
Fundación la Marató de TV3 (202220-30-31, 202220-30-31, 202220-30-31, 202220-30-31, 202220-30-31, 202220-30-31, 202220-30-31, 202220-30-31)
PFIS ISCIII (FI23/00004, FI23/00004)
the Secretaria d’Universitats i Recerca del Departament d’Economia i Coneixement of the Generalitat de Catalunya AGAUR 2021 (SGR 00624, SGR 00624, SGR 00624, SGR 00624, SGR 00624, SGR 00624, SGR 00624, SGR 00624)
CIBER of Epidemiology & Public Health (CIBERESP; CB06/02/0046, CIBERESP; CB06/02/0046, CIBERESP; CB06/02/0046, CIBERESP; CB06/02/0046, CIBERESP; CB06/02/0046, CIBERESP; CB06/02/0046)
the Health Research Board Ireland (ERAPERMED2022, ERAPERMED2022)
the Swedish Innovation Agency (no. 2022-00549, no. 2022-00549)
the Research Council of Norway (project no. 342386, project no. 342386, project no. 342386)
Article History
Received: 29 February 2024
Accepted: 5 March 2024
First Online: 20 March 2024
Declarations
:
: All aspects of the research protocol have been approved by the respective Institutional Review Boards at the relevant participating sites. In Catalonia (Spain), the IRB was the Parc de Salut Mar Clinical Research Ethics Committee (study 2022/10681/I and 2022/10325/I); in Sweden, the Swedish Ethical Review Authority (no. 2012/1669-31/5 and no. 2023-02336-02); in Norway, the Regional Ethical Committee for Medical and Health Research (ref. 2013/1620/REK south-east); and in Ireland by the Clinical Research Ethics Committee (Review Reference number- ECM 3 [qq] 06/02/2024).The processing of electronic registry data (i.e., data harmonization followed by the development of prediction models) does not involve research with human subjects or the joint processing of personal data. The requirement of explicit informed consent for the use of this data has been waived at all sites given that such requirement would make any registry-based research impossible, and given that strict data protection regulations are in place to minimize risk for subject identification (e.g., anonymization and/or registry data access through highly-secure virtual environments).Implementation research activities will adopt technical and procedural measures to strictly follow the EU and National General Data Protection Regulations, and will be in line with the principles established by national and international regulations, including the Declaration of Helsinki and the Code of Ethics. All personal data will be handled following Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation, GDPR) and corresponding national laws from the participating countries. Proposed data collection procedures are relevant and limited to the purposes of the project. Collected data will be stored on secure servers and will be pseudo-anonymised using encrypted identifiers to ensure privacy. All participants in implementation research will give explicit informed consent for participation following GDPR articles 6.1a and 9.2a. Implementation research activities will always occur in setting where high-quality effective treatment is available.
: Not applicable.
: The authors declare no competing interests.