Bibliographical noteFunding Information:
Funding This work is supported by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (Grant Ref: 16/142/04). The study is also supported by the Royal College of Surgeons Surgical Trials Centre in Bristol. JB, CR, BR and KA are all supported by the NIHR Bristol and Weston Biomedical Research Centre. JB is an NIHR senior investigator. The study sponsor is Leeds Teaching Hospitals NHS Trust (Research Governance Manager Anne Gowing, firstname.lastname@example.org), and the study is managed by the Bristol Trials Centre, Clinical Trials and Evaluation Unit. This study was designed and is being delivered in collaboration with the Bristol Trials Centre, Clinical Trials and Evaluation Unit, a UK Clinical Research Collaboration registered clinical trials unit, which is in receipt of NIHR clinical trials unit support funding. The research team acknowledges the support of the NIHR Clinical Research Network. The Sunflower Study is overseen by an independent SSC and DMSC. The study has been designed with input from public and patient groups.
Acknowledgements The authors would like to thank all study staff involved in recruitment, coordination and data collection for this study, and members of the patient and public involvement group who assisted with study design and review of study documents. Special thanks are also given to the clinical and nursing teams at participating centres for their support in the conduct of the study. The authors would like to acknowledge the data monitoring and safety committee (DMSC) and study steering committee (SSC) for their oversight of the study. The independent DMSC is formed of a chairperson, one consultant surgeon and one consultant radiologist. The SSC is formed of a chairperson, two consultant surgeons, two consultant radiologists, one medical statistician and two public and patient involvement representatives; other SSC members with observer status represent the study executive group (SEG) in these committees. The Sunflower SEG is made up of the following: Madeleine Clout, Jane Blazeby, Chris Rogers, Barnaby Reeves, Michelle Lazaroo, Kerry Avery, Natalie Blencowe, Ravi Vohra, Neil Jennings, William Hollingworth, Joanna Thorn, Marcus Jepson, Jane Collingwood, Ashley Guthrie, Elizabeth Booth, Samir Pathak, Ian Beckingham, Lucy Culliford, Ewen Griffiths, Raneem Albazaz and Giles Toogood. Patients and/or the public were involved in the design of this research. Patients and/or the public are/will be involved in the conduct, reporting and dissemination plans of this research. Refer to the Methods section for further details. The study is formally supported by the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland and the Great Britain & Ireland Hepato Pancreato Biliary Association, both of which recognise the importance of the objectives of this study.
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