Schick-Makaroff, Kara
Wozniak, Lisa A.
Short, Hilary
Davison, Sara N.
Klarenbach, Scott
Buzinski, Robert
Walsh, Michael
Johnson, Jeffrey A. https://orcid.org/0000-0001-8290-2857
Funding for this research was provided by:
can-solve ckd network (SCA-145103)
euroqol research foundation (20180170)
Article History
Received: 23 June 2021
Accepted: 7 October 2021
First Online: 28 October 2021
Declarations
:
: Ethics approvals for the study were granted from the University of Alberta (Health Research Ethics Board Pro00077850 and Pro00085021). All study methods were performed in accordance with the guidelines and regulations of the Health Research Ethics Board at the University of Alberta, protecting participants’ human rights, privacy, and confidentiality. Informed consent was obtained from participants, under the qualitative study. The remaining data sources came from the EMPATHY trial which was approved to be conducted under a waiver of consent from the University of Alberta Health Research Ethics Board (Pro00077850). This was considered appropriate because PROM collection was occurring already, or was planned to be implemented, as determined by the renal program; the intervention (linking the PROM to patient/provider discussion) is of minimal risk to patients, and all treatments are ascribed based on the provider judgment, not by study protocol; seeking informed consent would not be feasible in the framework of making this part of routine clinical care; seeking informed consent would likely bias participation resulting in inaccurate estimations of effect which would render the results of the trial uninformative for the use of these measures as part of routine care. All study methods were performed in accordance with the guidelines and regulations of the Health Research Ethics Board at the University of Alberta, protecting participants’ human rights, privacy, and confidentiality.
: Not required.
: Jeffrey A. Johnson is a member of the EuroQol Group and a member of the Board of Directors for the EuroQol Research Foundation. All authors have no other conflicts of interest to declare.