Funding for this research was provided by:
Received: 2 April 2019
Accepted: 21 August 2019
First Online: 14 September 2019
Ethics approval and consent to participate
: The study protocol has been reviewed and approved by the sponsor (ZonMw, The Netherlands Organization for Health Research and Development) and the accredited Medical Research Ethics Committee (MREC, Commission for Research in Human Subjects, in Dutch: Commissie Mensgebonden Onderzoek (CMO), region Arnhem – Nijmegen, the Netherlands). The MREC “CMO Regio Arnhem-Nijmegen” determined that the RACE study does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO). Informed consent was obtained from all individual participants included in the study.
: The authors declare that they do not have any competing interests. CM, JG, CW, FW, and MR are currently conducting a comparative effectiveness study on the (cost-)effectiveness of radical cystectomy, named the RACE study (trial identifying number NTR5362, Dutch Trial Registry, ExternalRef removed), in which the PROMs under study are being administered (among other outcome measures). However, in the authors’ opinion this does not pose a conflict of interest, since results of the current study will not have any consequences for the measurement instruments used in the RACE study nor will future results of the RACE study affect the current manuscript. All primary and secondary outcomes of the RACE study have been predefined in the registered and published trial protocol.