van Wietmarschen, Herman A. http://orcid.org/0000-0003-2225-0337
Busch, Martine
van Oostveen, Annemiek
Pot, Gerda
Jong, Miek C.
Funding for this research was provided by:
Winclove BV (no number)
Article History
Received: 5 September 2019
Accepted: 6 May 2020
First Online: 13 May 2020
Ethics approval and consent to participate
: Residents or their family members were asked to sign an informed consent form for using their data for the outcome evaluation. All participants consented to the use of their data and written informed consent was obtained from each participant. On 25 October 2017, a statement was received from the Ethical Committee in Brabant the Netherlands (no. 2017–56), that this evaluation did not involve experiments with patients or study subjects according to the Dutch Medical Research in Human Subjects Act (WMO) and didn’t require further ethics approval. Therefore, the PPE proved to be exempt from further medical ethical review according to Dutch national guidelines and laws (ExternalRef removed). The institutional review board and the client council of the Rivas Zorggroep approved the implementation and evaluation of probiotics.
: All participants gave written informed consent for using their data. No data of individual participants is reported in the manuscript. The data file InternalRef removed Data contains data that cannot be traced back to individuals.
: HAW, GP, and MB received funding from Winclove BV. to conduct the participatory pragmatic evaluation.