Funding for this research was provided by:
ZonMw (541001 004)
Received: 14 November 2019
Accepted: 17 February 2020
First Online: 27 February 2020
Ethics approval and consent to participate
: The research falls under the scope of the Medical Research Involving Human Subjects Act (WMO), therefore it was reviewed by an accredited Medical Research and Ethics Committee (MREC). The MREC of VU University medical center approved the study protocol under number NL62832.029.17, in compliance with the Helsinki Declaration and Dutch national legislation. The provided ethics approval from the MREC applies to all study sites. Prior to study commencement, the MREC gave formal approval for each study centre to participate in the study, and the Board of Directors of each study centre gave permission for execution of the study in their centre by signing a participation agreement.Written informed consent will be obtained from all study participants. The informed consent procedure consists of two steps:1) Written information is provided to either the resident or representative (depending on competence status, as judged by the physician), prior to study commencement or upon NH admission. At this time and throughout the study period, the resident/representative is given the opportunity to opt-out. If opted-out, step two will not be initiated.2) In case of a suspected LRTI, the physician contacts the patient/representative to ask for consent, which includes the opportunity to ask questions. In both groups, consent is asked for data collection. In the intervention group, consent is additionally asked for performing CRP POCT. An exceptional case is the situation in which the patient or the representative is not able to provide consent at the time of the diagnosis (e.g. if the patient is too ill or if the representative is not present): in that case, a physician can use CRP POCT as part of usual care if this is considered to support proper management. Consent is asked in retrospect (i.e. deferred consent), as soon as possible and at an appropriate moment, for data collection and potential future CRP POCT use.
: Not applicable.
: TB, LB, MH, RV, TH and CH have no competing interests to declare. RH is currently affiliated with “SHL-groep”, which is a non-commercial organisation founded by general practitioners. SHL-groep provides diagnostic services for general practitioners.