Vanorio-Vega, Isabella http://orcid.org/0000-0003-4639-8862
Constantinou, Panayotis http://orcid.org/0000-0003-4023-5915
Hami, Assia
Cellarier, Eric
Rachas, Antoine http://orcid.org/0000-0001-9226-9071
Tuppin, Philippe http://orcid.org/0000-0001-5698-9215
Couchoud, Cécile http://orcid.org/0000-0002-9273-660X
Article History
Received: 11 April 2023
Accepted: 14 October 2023
First Online: 24 October 2023
Declarations
:
: The creation of the REIN registry was approved by the relevant French committees: the Comité consultatif sur le traitement de l’information en matière de recherché (CCTIRS N°03–149) and the Commission nationale de l’informatique et des libertés (CNIL N° 903188). For population-based registries requiring exhaustiveness, French regulations require that patients be informed by the clinic that if he/she opposes to his nominative data recording, he/she will be anonymously recorded. Patients’ under the CNIL regulations have the right to withdrawal information have been anonymized and de-identified before the extraction for analysis. Patients in the REIN registry have been given the option to opt out from the use of their personal data. Those who consented have consented to the use of data for research. The use of the databases are under compliance of the approval by CNIL (French regulations), more information’s on: The Data Protection Act | CNIL [Internet]. [Cited 2023 Apr 19]. Available from: ExternalRef removed. Patients information letter and REIN compliance details (REIN information letter) available at: R.E.I.N. (Réseau Epidémiologique et Information en (…)—Agence de la biomédecine [Internet]. 2021. Available from: ExternalRef removedThe French national health insurance (CNAM) in charge of the SNDS (Système National des Données de Santé) has permanent access to the pseudonymized reimbursement data in application of the provisions of articles R. 1461‐12 et seq. of the French Public Health Code, with rules and criteria similar to the Helsinki declaration and permanent full access to the SNDS by decree (Décret n° 2016–1871 du 26 décembre 2016 relatif au traitement de données à caractère personnel dénommé « système national des données de santé»). The CNAM has authorization to perform studies based on SNDS data from the CNIL (National independent Commission for Computing and Freedom, the French data protection agency for sensitive information). All methods were carried out in accordance with relevant guidelines and regulations.The main author of this article is under the ethical requirement of both the Agence de la biomédecine (institution managing the REIN registry and database) as well as the CNAM. The scientific committee from the biomedical agency approved the use of their databases for this study.
: Not applicable.
: The authors declare no competing interests.