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Funding for this research was provided by:
London School of Hygiene and Tropical Medicine (EPAA6020)
Article History
Received: 14 October 2019
Accepted: 28 January 2020
First Online: 19 February 2020
Compliance with ethical standards
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: Abda Mahmood, Adrian Boyle, Antonio Belli, Caroline Leech, Darin Wong, David Davies, Fatahul Laham Mohamed, Haleema Shakur-Still, Hamzah Lotfi, Ian Roberts, Jason Kendall, Kelly Needham, Mark Wilson, Melanie Darwent, Phillip Hopkins, Phil Moss, Sabariah Faizah Jamaluddin and Tim Harris have no conflicts of interest to declare. Antonio Belli was in receipt of a grant from the National Institute for Health Research during the conduct of the study.
: Following the publication of the analyses detailed in the CRASH-3 IBMS statistical analysis plan, individual de-identified patient data, including a data dictionary, will be made available via our data-sharing portal, The Free Bank of Injury and Emergency Research Data (freeBIRD) website (ExternalRef removed) indefinitely. This will allow for maximum utilisation of the data to improve patient care and advance medical knowledge. The study protocol, statistical analysis plan and publications will be freely available at ExternalRef removed. If additional analyses are proposed, we would request a protocol and expect that a data access agreement is in place.
: In the CRASH-3 trial, patients were unable to provide consent and so consent was sought from the patient’s relative, legal representative, or the responsible clinician. If and when the patient regained capacity to provide informed consent, they were informed about the trial and written consent sought to continue participation in the trial. If a patient or patient representative declined consent, they were withdrawn from the trial. For patients who were included in the trial but did not regain capacity, written informed consent was sought from a relative or legal representative. The requirements of relevant local and national ethics committees were adhered to at all times. The CRASH-3 trial included consent to extract data from patient medical records. Collecting CT scan data for the explanatory study was consistent with the consent procedure used in the CRASH-3 trial. It would be impractical to re-consent patients or relatives/legal representatives to access CT scans, particularly for patients who had deceased or were disabled as a result of their injuries where re-consent would have been distressing and unwelcome. The London School of Hygiene and Tropical Medicine and national Ethics Committees extended their approvals to extract CT data from the CRASH-3 trial without further patient consent. Patients who withdrew from the main CRASH-3 trial were not included in the explanatory study.
: The Medical Research and Ethics Committee and Health Research Authority reviewed the protocol and supporting documents for the CRASH-3 explanatory study and provided a favourable ethical opinion on 8 June 2016 (Research Ethics Committee Reference 12/EE/0274). All participating hospitals provided local approvals and letters of access for the CRASH-3 explanatory study to be conducted at their respective sites. Favourable ethical opinion was received from the Observational/Interventions Research Ethics Committee at the London School of Hygiene and Tropical Medicine on 24 May 2016 (Reference 11535).