van den Biggelaar, Ries J.M.
Hazenberg, A.
Cobben, N. A.M.
Gaytant, M. A.
Gommers, D. A.M.P.J.
Wijkstra, P. J.
Funding for this research was provided by:
ZonMw (837002501)
Vivisol
Article History
Received: 18 March 2022
Revised: 29 September 2022
Accepted: 19 October 2022
First Online: 9 November 2022
Declarations
:
: The data described in this article is distracted from the original study data which is already published. This original study was approved by the UMCG institutional review board (approval number 2014/529), Monitoring was performed on all sites by an external monitor, and a Data Safety Monitoring Board was installed. Individuals have given their written informed consent. Patients who were excluded from the original study no informed consent was obtained, this wasn’t necessary, because only the reason for not participating was noted. All procedures were performed in accordance with relevant guidelines. The study was registered in the Dutch trial register (NTR4683) and later internationally (Clinicaltrials.Gov ID: NCT03203577).
: Patients included in the study were informed by the investigator that results would be published. The group of non-participants was logged but didn’t consent for publication, because their specific situation for not participating in the study is categorized and therefore not seen as direct patient information and not involving or harmful for these patients. We see this data as management information for improving health care organization.
: Dr. van den Biggelaar reports personal fees from Philips, and Westfalen Medical B.V., both outside the submitted work. Dr. Hazenberg, Dr. Cobben, Dr. Gaytant and Dr. Gommers have nothing to disclose. Prof. Dr. Wijkstra reports grants from ZONMW, grants from VIVISOL, during the conduct of the study; grants and personal fees from Philips, grants and personal fees from RESMED, grants from Goedegebuure, grants from vital air, personal fees from Bresotec, and personal fees from Synapse, outside the submitted work.