Cook, Jonathan A. https://orcid.org/0000-0002-4156-6989
Baldwin, Mathew
Cooper, Cushla
Nagra, Navraj S.
Crocker, Joanna C.
Glaze, Molly
Greenall, Gemma
Rangan, Amar
Kottam, Lucksy
Rees, Jonathan L.
Farrar-Hockley, Dair
Merritt, Naomi
Hopewell, Sally
Beard, David
Thomas, Michael
Dritsaki, Melina
Carr, Andrew J.
Funding for this research was provided by:
National Institute for Health Research (15/103/03)
Article History
Received: 11 March 2021
Accepted: 6 August 2021
First Online: 20 August 2021
Declarations
:
: This feasibility study was reviewed and approved to proceed by the University of Oxford Joint Research Office (JRO) study classification group (ref: PID13023). The JRO determined that the PARCS study falls outside of the definition of research that requires Health Research Authority (HRA) ethical approval and therefore was not subject to the Department of Health’s Research Governance Framework for Health and Social Care (2005). It did not therefore require further assessment or approval prior to commencement. Informed consent will be sought from participants as detailed in the main body of this paper.
: Not applicable.
: Jonathan A Cook reports various grants from the National Institute for Health Research (NIHR), including studies funded by the Health Technology Assessment (HTA) programme and a project funded by NIHR Invention for Innovation evaluating an electrospun patch to augment rotator cuff tendon repair. He was a member of the NIHR HTA programme’s Efficient Trial Designs, and End of life Care and Add-on Studies boards between 2014 and 2016. Joanna C Crocker reports grants from the NIHR HTA programme during the conduct of the study and grants, personal fees and non-financial support from the University of Oxford outside the submitted work. Sally Hopewell has been a member of the HTA Clinical Evaluation and Trials committee from 1 November 2018 to present. Amar Rangan reports various grants from NIHR, Orthopaedic Research UK (London, UK), DePuy Synthes (Raynham, MA, USA) and Horizon 2020 outside the submitted work. Lucksy Kottam reports various grants from NIHR and DePuy Synthes outside the submitted work. Andrew J Carr reports the following grants from NIHR: Senior Investigator Award, Biomedical Research Centre (Musculoskeletal Disease) and the i4i programme grant ‘A novel electrospun patch to augment rotator cuff tendon repair’.Andrew Carr has applied for a patent that will be considered as part of this work. We have carefully designed a robust research strategy that incorporates substantial independent input throughout to ensure no one individual, whether they are within or out the project team, could have had undue influence on the process. Amar Rangan has received educational and research grants from DePuy Ltd. outside the scope of this work. The authors declare that they have no other conflicts of interest.