Received: 15 April 2020
Accepted: 28 July 2020
First Online: 26 November 2020
Change Date: 28 January 2021
Change Type: Correction
Change Details: Following publication of the original article , the authors flagged that the article had published with the Acknowledgements erroneously excluded from the declarations at the end of the article.
Ethics approval and consent to participate
: This study protocol, informed consent forms and other relevant documents have obtained favourable opinion from the UK Health Research Authority (HRA) (ID: 238990) and by the Research Ethics Committee (REC) of the University of Birmingham (ID: RG_18–142), and all participants completed an informed consenting process with a member of the research team. Written informed assent and consent in accordance with the Declaration of Helsinki will be obtained and the study will be conducted in accordance with the UK Policy Framework for Health and Social Care Research, the applicable UK Statutory Instruments, the General Data Protection Regulation (GDPR) / Data Protection Act 2018, and Guidelines for Good Clinical Practice (GCP). Amendments agreed between the CI and the sponsor, and approved UK Health Research Authority, will be communicated in writing to relevant stakeholders (e.g. REC, R&D). Participants may withdraw from the trial at any point without any penalty and will not receive compensation for taking part in the study. Personal information about participants collected during the consent/data collection processes are stored securely in a locked cabinet, in a locked office. Data from the software, stored electronically for the purpose of data analysis, will be password protected and participants will be identified by study code only. Data from the training task will be anonymous with only a subject code as identifier, encrypted via https during transit, and stored on a Dalhousie University-protected server. Confidentiality will be maintained by coding each participant’s data using an alphanumerical system with keys relating individuals to participant codes, kept in a separate locked place (off line) and destroyed after 1 year. Any reported adverse events and unintended effects will be discussed amongst the research team and dealt with on a case-by-case basis.
: Not applicable.
: SA, KS, GE are named inventors on a patent application (108165P.GBA) jointly submitted by University of Birmingham and Dalhousie University; RH, MR, CG have no competing interests to declare. The sponsor is not involved in study design, conduct, data analysis and interpretation, manuscript writing, and dissemination of results, and neither controls the final decision regarding any of these aspects of the study.