Huijgens, Anneloes N. J.
van Baardewijk, Laurens J.
Keijsers, Carolina J. P. W.
Article History
Received: 5 May 2021
Accepted: 19 January 2022
First Online: 3 February 2022
Declarations
:
: The regional ethical review board (METC Brabant/18.238, #NW2018–37) declared that this study falls outside the scope of the Dutch Law on Medical Research (WMO) and approved the study design. Informed consent was not asked from the participants, accordance to the Dutch Medical Treatment Contracts Act (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 undesirable side effect. However, patients who had previously objected to their information being used for scientific research, by the hospital opt-out procedure, were excluded. We used already existing data and patients and families were not approached for any additional data. The physical and psychological integrity of the patients were intact during this research and were not harmed in any way. The study is carried out according to the principles of the WMA Declaration of Helsinki; 2013.
: Not applicable.
: The authors declare that they have no competing interests