de Gans, Simon T.
Maessen, Gerdinique C.
van de Pol, Marjolein H. J.
van Apeldoorn, Marjan J.
van Ingen-Stokbroekx, Margot A. L.
van der Sloot, Niels
Keijsers, Carolina J. P. W.
van der Zwaard, Babette C.
Funding for this research was provided by:
Jeroen Bosch Ziekenhuis
Article History
Received: 28 December 2022
Accepted: 11 August 2023
First Online: 26 August 2023
Declarations
:
: The ICW was set up to improve health care and not for research purposes. The Ethics Review Board METC Brabant (reference id: NW2021-24) approved the study design and declared that, owing to its retrospective nature, the study fell outside the scope of the Dutch Medical Research Involving Human Subjects Act. This study was carried out according to the principles of the Declaration of Helsinki. Informed consent was not asked from the participants in accordance to the Dutch law WGBO, article 458. Because of the high number of participants included, taking informed consent was considered not reasonably possible, and above that selection bias could be included by taking informed consent as an undesirable side effect. However, patients who had previously objected to their information being used for scientific research, by hospital opt-out procedure, were excluded. The Ethics Review Board METC Brabant (reference id: NW2021-24) waived the need for informed consent.
: Not applicable.
: The authors declare no competing interests.