Additional information

Acknowledgements

Data Monitoring Committee members

Mike Bradburn, Catey Bunce and Anju Jaggi

Trial Steering Committee members

Melinda Cairns, Alex McConnachie, Susan Jowett, Rachel Chester and Alwin McGibbon

Recruitment centres

1. University Hospital Coventry and Warwickshire
2. Royal Free London NHS Foundation Trust
3. Yeovil District Hospital NHS Foundation Trust
4. Southmead Hospital Bristol
5. Harrogate and District NHS Foundation Trust
6. University Hospital of North Tees
7. Norfolk & Norwich University Hospital NHS Foundation Trust
8. Royal Devon and Exeter Hospital
9. Addenbrookes Hospital
10. Royal Derby Hospital
11. Leicester Royal Infirmary
12. Royal Victoria Infirmary
13. Calderdale and Huddersfield NHS Foundation Trust
14. North West Anglia NHS Foundation Trust
15. Airedale NHS Foundation Trust
16. Ashford and St Peter’s Hospitals NHS Foundation Trust
17. Oxford University Hospital NHS Foundation Trust
18. Milton Keynes University Hospital
19. Blackpool Teaching Hospital NHS Foundation Trust
20. Royal Cornwall Hospital and Cornwall Partnership Trust
21. Royal Berkshire Hospital
22. Sheffield Teaching Hospital
23. York Teaching Hospital NHS Foundation Trust
24. Doncaster & Bassetlaw Teaching Hospitals NHS Trust
25. United Lincolnshire Hospitals NHS Trust
26. Grampian Health Board
27. Warrington and Halton Hospitals NHS Trust
28. East Suffolk and North Essex NHS Foundation Trust
29. Somerset NHS Foundation Trust
30. Glasgow Royal Infirmary
31. Royal Blackburn Teaching Hospital
32. Sunderland Royal Hospital
33. West Suffolk Hospital
34. King’s College London
35. St George’s University Hospitals NHS Foundation Trust
36. University Hospitals of Morecambe Bay NHS Foundation Trust
37. North Cumbria University Hospital NHS Trust
38. East Cheshire NHS Trust
39. Pilgrim Hospital
40. Grantham and District Hospital.

Contributions of authors

Rebecca Kearney (https://orcid.org/0000-0002-8010-164X) (Professor) was responsible for study conception, trial design, obtaining grant funding, trial management and acquisition of data.

David Ellard (https://orcid.org/0000-0002-2992-048X) (Professor) was responsible for study conception, trial design, obtaining grant funding and trial management.

Helen Parsons (https://orcid.org/0000-0002-2765-3728) (Associate Professor Statistics) was responsible for study conception, trial design, obtaining grant funding, trial management and the statistical analysis.

Aminul Haque (https://orcid.org/0000-0003-3589-6751) (Research Associate, Statistician) was responsible for the statistical analysis.

James Mason (https://orcid.org/0000-0001-9210-4082) (Professor, Health Economics) was responsible for study conception, trial design, obtaining grant funding, trial management and the health economics analysis.

Henry Nwankwo (https://orcid.org/0000-0001-7401-1923) (Assistant Professor Health Economics) was responsible for the health economics analysis.

Helen Bradley (https://orcid.org/0009-0003-1663-4462) (Senior Project Manager) was responsible for leading trial management operations.

Steve Drew (https://orcid.org/0000-0002-9523-682X) (Orthopaedic Consultant) were responsible for study conception, trial design, obtaining grant funding and trial management.

Chetan Modi (https://orcid.org/0009-0008-3337-4419) (Orthopaedic Consultant) were responsible for study conception, trial design, obtaining grant funding and trial management.

Howard Bush (https://orcid.org/0000-0001-9360-0504) (Physiotherapist) were responsible for study conception, trial design, obtaining grant funding and trial management.

David Torgerson (https://orcid.org/0000-0002-1667-4275) (Professor) were responsible for study conception, trial design, obtaining grant funding and trial management.

Martin Underwood (https://orcid.org/0000-0002-0309-1708) (Professor) were responsible for study conception, trial design, obtaining grant funding and trial management.

All authors were responsible for the interpretation of the data and for drafting and approving the final monograph.

Disclosure of interests

Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/CMYW9226.

Primary conflicts of interest: All authors have read and concur with the content of this monograph. All authors meet the uniform requirements for manuscripts submitted to biomedical journals criteria for authorship. All authors confirm that they have approved the monograph for submission.

Rebecca Kearney is a previous member of the UK NIHR HTA CET board, NIHR ICA Doctoral panel and chair of the NIHR RfPB panel. Rebecca Kearney is current subcommittee chair for NIHR PGfAR. James Mason is a member of NIHR HTA Efficient Study Designs, HTA End of Life Care and Add-on Studies and HS&DR Funding Committee Member. David Torgerson was a member of HTA Medicines for Children Themed Call and is currently a member of CTUs funded by NIHR. Martin Underwood was a member of NIHR Journals Library Editors Group.

Rebecca Kearney, David Ellard, Helen Parsons, Ainul Haque, James Mason, Henry Nwamkwo, Steve Drew, Chetan Modi, Helen Bradley, David Torgerson and Martin Underwood have all been awarded current and previous NIHR research grants.

Martin Underwood and Rebecca Kearney are co-investigators on grants funded by the Australian NHMRC, and Helen Parsons, Martin Underwood and Rebecca Kearney have been co-applicants on NIHR funded studies receiving additional support from Stryker Ltd.

Martin Underwood is a co-investigator on grants funded by Norwegian Medical Research Council. He is a director and shareholder of Clinvivo Ltd that provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd, funded by the European Social Fund, related to return-to-work initiatives.

Data-sharing statement

All data requests should be submitted to WCTUDataAccess@warwick.ac.uk for consideration. Access to anonymised data may be granted following review.

Ethics statement

The National Research Ethic Committee approved this study on 26 July 2018 (18/WA/0236), with each trial site granting individual NHS Trust approval prior to recruitment at each site.

Information governance statement

The University of Warwick is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, University of Warwick and University Hospitals Coventry and Warwickshire are the Data Controller.

Department of Health and Social Care disclaimer

This publication presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, NIHR Coordinating Centre, the HTA programme or the Department of Health and Social Care.

This monograph was published based on current knowledge at the time and date of publication. NIHR is committed to being inclusive and will continually monitor best practice and guidance in relation to terminology and language to ensure that we remain relevant to our stakeholders.

Disclaimers

This manuscript presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.