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Article History

Received: 24 November 2023

Accepted: 10 April 2024

First Online: 28 April 2024

Declarations

:

: The SNDS is a medico-administrative database of insured persons, and all patient-level data used for this retrospective analysis were collected as part of routine diagnosis and treatment. A unique anonymous identification number was associated to each insured person; as such, all data were fully anonymized prior to access and inclusion in this study. In accordance with the regulations in force, patient consent was not necessary because this study uses secondary data, there was a public interest in assessing the costs and clinical management of PID and SID patients in France, and the protection of patients’ rights and freedom were guaranteed. The authorization to use the data was granted by the French data protection authority (Commission Nationale de l’Informatique et des Libertés, CNIL) (Decision DR-2019-009, and authorization No. 918434) and the study protocol obtained approval from the committee for research, studies, and evaluations in the field of health (Comité d’expertise pour les recherches, les études et les évaluations dans le domaine de la santé, CEREES) (Decision TPS-235223).

: Consent for publication: Not applicable.The study is based on secondary claims data and complied with regulations in force. Patient consent was not necessary. The persons concerned are informed of the implementation of the SNDS and the possible re-use of their personal health data in accordance with the procedures defined by Article R.1461-9 of the Public Health Code. The authorization to use the data was granted by the French data protection authority (Commission Nationale de l’Informatique et des Libertés, CNIL) (Decision DR-2019-009, and authorization No. 918434) and the study protocol obtained approval from the committee for research, studies, and evaluations in the field of health (Comité d’expertise pour les recherches, les études et les évaluations dans le domaine de la santé, CEREES) (Decision TPS-235223). This study is a non-interventional study on pseudonymized data and does not involve humans (nor animals).

: PMB reports support for the present manuscript from Vifor; Honoraria for lectures and board (personal fees) from Astellas, honoraria for lectures and board (personal fees) from Vifor; Support for attending meetings and/or travel from Sanofi and Vifor; Participation on a Data Safety Monitoring Board or Advisory Board for Astellas and Vifor. C-AD reports support for the present manuscript from Vifor and support for attending meeting and/or travel from Boehringer Ingelheim. DC has no conflict of interest to declare but support for the present manuscript from Vifor. AS reports working for HEVA, the company who carried out the study funded by Vifor. EST reports support for the present manuscript from Vifor; Grants or contracts from Astra Zeneca and Bayer; consulting fees from Bayer; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astra Zeneca and support for attending meetings and/or travel from Vifor and Amgen. BT reports consulting fees from Astra Zeneca, Vifor, and GlaxoSmithKline; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astra Zeneca, Vifor, GlaxoSmithKline, and Boehringer Ingelheim and support for attending meetings and/or travel from Vifor and GlaxoSmithKline.