Lee, Xing J. http://orcid.org/0000-0002-8803-2810
Farrington, Alison
Carter, Hannah
Shield, Carla
Graves, Nicholas
McPhail, Steven M.
Harvey, Gillian
White, Ben P.
Willmott, Lindy
Cardona, Magnolia
Hillman, Ken
Callaway, Leonie
Barnett, Adrian G.
Funding for this research was provided by:
National Health and Medical Research Council (GNT1151923)
Article History
Received: 4 March 2020
Accepted: 20 July 2020
First Online: 29 July 2020
Ethics approval and consent to participate
: This study received ethics approval for all participating hospitals from the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC) (Approval HREC/2019/QRBW/51606) and the QUT HREC (Approval 1900000630). These approvals include a waiver of consent for access to patient data and to health services data. A Public Health Act (PHA) application has been approved for patient data linkage for this project (RD008146). In accordance with the Queensland Health Research Governance requirements, Site Specific Assessment (SSA) approvals have been obtained from the three participating public hospital sites (GCUH, RBWH, TPCH).All subsequent protocol amendments will be submitted as a variation to the approving ethics committees. The project manager will notify the ethics committees of deviations from the protocol or serious adverse events occurring at the hospital in accordance with local procedures.Each participant will provide written informed consent for participation prior to the interviews.The trial is prospectively registered with the Australia New Zealand Clinical Trial Registry (ANZCTR), ACTRN12619000675123p (registered 6 May 2019).
: No individual person’s data is included in the manuscript.
: MC and KH developed the CriSTAL tool and validated it in multiple settings before this study using funding from the National Health and Medical Research Council of Australia. They derive no financial or other personal benefit from its use in this study. All other authors declare that they have no competing interests.