Brown, Christine
Lee, Xing J.
Farrington, Alison
Shield, Carla
Carter, Hannah E.
McPhail, Steven M.
Cardona, Magnolia
Hillman, Kenneth
Callaway, Leonie
Willmott, Lindy
White, Ben P.
Harvey, Gillian
Graves, Nicholas
Barnett, Adrian G.
Article History
Received: 29 April 2022
Accepted: 21 October 2022
First Online: 16 November 2022
Declarations
:
: The trial is prospectively registered with the Australia New Zealand Clinical Trial Registry (ANZCTR), ACTRN12619000675123 (registered 6 May 2019). This trial 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 the requirement of informed consent for access to patient data and to health services data. A Public Health Act (PHA) Application has been approved for patient data linkage. In accordance with the Queensland Health Research Governance requirements, Site Specific Assessment (SSA) approvals have been obtained from the three participating public hospital sites (Gold Coast University Hospital, Royal Brisbane and Women’s Hospital, The Prince Charles Hospital).This study was carried out in accordance with regulatory guidelines of the NHMRC and ANZCTR and all methods align with the HREC approved protocol.
: No individual person’s data is included in the manuscript.
: MC and KH developed and validated the CriSTAL tool in 2014 but derive no benefit whatsoever from its open access use by others. All other authors declare that they have no competing interests.