Acknowledgements | Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT

Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT · Acknowledgements

Acknowledgements

We thank all those who took part in the trial and clinical staff at the participating sites.

Sponsor

The University of Leeds acted as sponsor for the research and the trial.

The seAFOod Collaborative Group

Trial and data management: Nottingham Clinical Trials Unit

Lelia Duley, Professor of Clinical Trials Research; Alan A Montgomery, Professor of Medical Statistics and Clinical Trials and Deputy Director; Trish Hepburn, Senior Medical Statistician; Wei Tan, Medical Statistician; Dan Simpkins, Senior Data Manager; Anna Sandell, Trial Manager from November 2011 to 2014; Kirsty Sprange, Trial Manager from May 2014 to August 2015 then Senior Trial Manager from 2015; Sarah Fahy, Trial Manager from October 2015 to September 2016; Aisha Shafayat, Trial Manager from December 2016; Eleanor Harrison, Trial Administrator from October 2011 to January 2012; Margarita Carucci, Trial Administrator from February 2012 to July 2014 then Trial Co-ordinator from August 2014 to August 2015; Natalie Hutchings, Trial Administrator from September 2014 to June 2016; Robert Allen, Trial Co-ordinator from August 2016; Gill Bumphrey, Trial Pharmacist from March 2011 to June 2015; Sarah Walker, Data Co-ordinator from February 2013 to August 2017; Matthew Foster, Data Administrator; Chris Rumsey, Information Technology Programmer; Justin Fenty, Statistician from April 2011 to September 2012; and Veronica Moroz, Statistician from May 2009 to December 2010.

Co-applicants

Richard F Logan, Professor of Clinical Epidemiology, University of Nottingham; Colin J Rees, Professor of Gastroenterology and Consultant Gastroenterologist, Newcastle University and South Tyneside NHS Foundation Trust; Gayle Clifford, South of Tyne Bowel Cancer Screening Centre, BCSP, SSPr; Paul M Loadman, Professor of Pharmacokinetics and Drug Metabolism, University of Bradford and Yorkshire Experimental Cancer Medicine Centre; Anna Nicolaou, Professor of Biological Chemistry, University of Bradford; Devon Devonport, Patient and Public Representative (BCSP Patient Representative); Paul Silcocks, Senior Lecturer in Medical Statistics, University of Nottingham; and Hywel Williams, Professor of Dermato-epidemiology, University of Nottingham.

Trial Management Group

Professor Mark A Hull, Professor of Molecular Gastroenterology and Honorary Consultant Gastroenterologist; Diane Whitham, Associate Professor in Clinical Trials; Alan A Montgomery, Professor of Medical Statistics and Clinical Trials and Acting Director; Anna Sandell, Trial Manager; Eleanor Harrison, Trial Administrator; Wei Tan, Medical Statistician; Eleanor Mitchell, Senior Trial Manager; Kirsty Sprange, Trial Manager/Senior Trial Manager; Margherita Carucci, Trial Co-ordinator; Gill Bumphrey, Trial Pharmacist; Sarah Fahy, Trial Manager; Natalie Hutchings, Trial Administrator; Brian Barnes, Data Manager; Matthew Foster, Data Administrator; Aisha Shafayat, Trial Manager; and Robert Allen, Trial Co-ordinator.

Trial Steering Committee (independent members)

Professor Will Steward (Chairperson), Triallist and ex-Chairperson, National Cancer Research Institute CRC Clinical Studies Group, University of Leicester; Professor Greg Rubin, Triallist with primary care gastroenterology expertise, Newcastle University Institute of Health Sciences; Sally Benton, Director, NHS Bowel Cancer Screening Southern Programme Hub (previous Director: Professor Stephen Halloran); Mr Alan Reece, BCSP Patient ‘Service User’ Representative; Dr Elmar Detering, Representative of Bayer Pharma AG (Observer); and Mr Justin Slagel, Representative of SLA Pharma AG, until IMP switch (Observer).

Data Monitoring Committee (independent members)

Professor Bob Steele (Chairperson), Professor of Surgery, University of Dundee; Professor Dion Morton, Consultant, University Hospitals Birmingham NHS Foundation Trust; and Professor John Norrie, Chair of Medical Statistics and Trial Methodology, Director of Edinburgh Clinical Trials Unit, University of Edinburgh.

Institute of Cancer Therapeutics, University of Bradford

Professor Paul M Loadman, Professor of Pharmacokinetics and Drug Metabolism; Ms Amanda Race, Research Assistant; Ms Elizabeth Macken, Research Assistant; and Ms Jade Spencer, Research Assistant.

University of Sheffield

Dr Elizabeth A Williams, Senior Lecturer in Human Nutrition.

Trial sites

North Tees and Hartlepool Hospitals NHS Foundation Trust: Matthew Rutter (PI), Debbie Wilson, Anne Eastick, Carol Adams, Susan Kelsey and Tracey Johnston on behalf of the site.
Newcastle upon Tyne Hospitals NHS Foundation Trust: John Mansfield (PI), Heather Dixon, Elaine Stephenson, Maria Price, Mary Doona, Bev Douthwaite, Carrie Parker, Emma Crossland, Julie James, Lesley Dodd, Nicola George, Sasha Skentelbery and Sharron Lee on behalf of the site.
Northumbria Healthcare NHS Foundation Trust: Tom Lee (PI), Mark Welfare (PI), Helen Bailey, Heather Dixon, Jane Dickson, Linda Patterson, Julie James, Lesley Dodd, Nicola George and Sasha Skentelbery on behalf of the site.
Derby Teaching Hospitals NHS Foundation Trust: Andrew Goddard (PI), Maria Hartley, Helen Gibbs, Tracey Ambler, Beverley Powell, Christine Harrison and Keren Kerr on behalf of the site.
Chesterfield Royal Hospital NHS Foundation Trust: Keith Dear (PI), Tracey Ambler, Carmel Cooke, Lucinda Wilson, Teri-Ann Sewell, Helen Gibbs and Maria Hartley on behalf of the site.
Norfolk and Norwich University Hospital NHS Foundation Trust: Ian Beales (PI), Siobhan Parslow-Willams, Carmen Walker, David Tomlinson, Gemma Shearing, Jocelyn Keshet-Price, Jodie Graham, Kerrie Self, Melissa Rosbergen and Rachel Stebbings on behalf of the site.
Calderdale and Huddersfield NHS Foundation Trust: Ashwin Verma (PI), Mandy Mellor, Bridget Keegan, Matthew Robinson, Natalie Austin, Philipa Gilbert and Stephanie Rich on behalf of the site.
The Mid Yorkshire Hospitals NHS Trust: Syed Shah (PI), Lynsey Bourner, Annette Jones, Deborah Cooper, Jackie Ward, Patricia Kane, Rebecca Foster, Sarah Buckley, Steph Lupton, Thelma Darian, Toni Rank, Tracey Lowry and Bridget Keegan on behalf of the site.
County Durham and Darlington NHS Foundation Trust: Clare Westwood (PI), Peter McCourt, Claire Shaw, Michelle Wood, Anna Archer, Emma Fenby, Gillian Matthews and Lynn Smith on behalf of the site.
City Hospitals Sunderland NHS Foundation Trust: John Painter (PI), Pauline Oates, Verity Bennet, Hayley McMillan, Tracey Robson, Amanda King, Angela Hamilton, Dawn Charlton, Gayle Clifford, Mary Ritchie, Nicola Dempsey and Pamela Bowden on behalf of the site.
Gateshead Health NHS Foundation Trust: Jitendra Singh (PI), Hayley McMillan, Verity Bennett, Ann Wilson, Sophie Gelder, Amanda King, Angela Hamilton, Dawn Charlton, Gayle Clifford, Mary Ritchie, Nicola Dempsey, Pamela Bowden, Sharon McCourt and Suzanne Nicholson on behalf of the site.
South Tyneside NHS Foundation Trust: Colin J Rees (PI), Gayle Clifford, Carly Brown, Philippa Laverick, Hayley McMillan, Mary Ritchie, Nicola Dempsey and Verity Bennett on behalf of the site.
Harrogate and District NHS Foundation Trust: Jonathan Harrison (PI), Barbara Heath, James Featherstone, Denise Cullingworth, Joanne Bell, Liz Potrykus and Pam Roth on behalf of the site.
Leeds Teaching Hospitals NHS Trust: Richard Baker (PI), Ruth Fazakerley, Annette Jones, Doris Quartey, Felicia Onoviran, Claire Burton, Denise Cullingworth, Joanne Bell, Melissa Mellis, Nicola Bell and Pamela Roth on behalf of the site.
York Teaching Hospital NHS Foundation Trust: James Turvill (PI), Nicola Broadley, Feveresterh Fallah, James Featherstone, Joanne Ingham, Julie Sackville Hamilton, Kay Kell, Paula Strider, Rebecca Coop, Denise Cullingworth and Elizabeth Potryrus on behalf of the site.
Bradford Teaching Hospitals NHS Foundation Trust: Linda Juby (PI), Sophie Stephenson, Karl Ward, Philippa El Sayed, Rhian Simpson, Wendy Jepson, Hilary Bayton and Natalie Austin on behalf of the site.
Airedale NHS Foundation Trust: Philip DaCosta (PI), Diana Wilkinson, Hilary Bayton, Jean Martin, Natalie Austin and Elleanor Waldron on behalf of the site.
Northern Lincolnshire and Goole NHS Foundation Trust: Syed Muzaffar Ahmad (PI), Kirstie Smith, Ruth Loveday, Karen Martin, Kathy Dent and Sandra Evans on behalf of the site.
North Cumbria University Hospitals NHS Trust: Frank Hinson (PI), Sara Underwood, Beverley Wilkinson, Christine Pearson, Jane Chester and Sue Meyrick on behalf of the site.
Hull and East Yorkshire Hospitals NHS Trust: Graeme Duthie (PI), Bronwen Williams, Martin Lewis, Paula Brown and Sally Wood on behalf of the site.
George Elliot Hospital NHS Trust: Edmond Sung (PI), Emiley Archer, Kerry Flahive and Linda Stretton on behalf of the site.
Nottingham University Hospitals NHS Trust: Steve Foley (PI), Julian Williams (PI), Alison Large, Joyce Ntata, Karen Newcombe, Kathryn Moore, Sarah Chadderton, Chris Murfita and Shelley Biddles on behalf of the site.
Northampton General Hospital NHS Trust: Udi Shmueli (PI), Ethelwolda Goyena, Andrea Jones, Caroline Duncombe, Elizabeth Tee, Jan Miles, Kathy McGrath, Mariska Pochin and Nancy Hopewell on behalf of the site.
Kettering General Hospital NHS Trust: Andrew Dixon (PI), Joanne Walsh, Andrew Chilton, Margaret Turns, Maria Hill, Arrah Ashuarey and Ellen Nkhata on behalf of the site.
University Hospitals of Leicester NHS Trust: John de Caestecker (PI), Alison Moore, Donna Ward, Elizabeth Andrzejewshi and Howard Fairey on behalf of the site.
University Hospitals Coventry and Warwickshire NHS Trust: Jayne Eaden (PI), Steven Clay, Denise Gocher, Susan Dawson, Linda Stretton, Carol Wheatley, Kerry Flahive, Emily Archer, Katie James, Jaqueline Farmer and Jaqui Dagush on behalf of the site.
South Warwickshire NHS Foundation Trust: Martin Osborne (PI) Kerry Flahive, Emily Archer and Lucy Hughes on behalf of the site.
University Hospitals of Morecambe Bay NHS Foundation Trust: Colin Brown (PI), Jill Condor, Carmel Thomas, Carol Summer, Jane Chester, Maggie Coughlan and Susan Meyrick on behalf of the site.
Poole Hospital NHS Foundation Trust: Sally Parry (PI), Diane Simpson, Tracey Deacy, Christine Dickson and Sarah Patch on behalf of the site.
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust: Sean Weaver (PI), Hannah Dewhurst, Emma Gunter, Ian Leadbitter, James Page, Nigel Butter, Nina Barratt, Maggie Bunce and Samntha Newman on behalf of the site.
Dorset County Hospital NHS Foundation Trust: James Shutt (PI), Chris Hovell (PI), Abby Oglesby, Karen Hogben, Jackie Gibbins and Vicky Hanson on behalf of the site.
Royal Surrey County Hospital NHS Trust: John Stebbing (PI), Karen Penry, Avril Adams, Daniel Jennings, Rachel Gallifent, Victoria Bartlett-Hunter, Anne Allen, Heather Swannack and Jessica Buckwell on behalf of the site.
Frimley Park Hospital NHS Trust: Henry Tilney (PI), Karen Penry, Carrie Burgess, Jacqueline Brighton, Anne Allen, Heather Swannack, Jessica Buckwell and Rachel Gallifent on behalf of the site.
Bolton NHS Foundation Trust: George Lipscomb (PI), Tracey Lawton, Janine Hurst, Jean Cummings, Karen Jewers, Louise Dawson, Shirley Cocks, Caroline Rogers and Gillian Cusack on behalf of the site.
King’s College Hospital NHS Foundation Trust: Guy Chung-Faye (PI), Rayhan Ahmed, Stefi Stegner and Mun Lim on behalf of the site.
Lewisham and Greenwich NHS Trust: John O’Donohue (PI), Abel Jalloh, Martha Handousa, Hazel Harrop, Katrina Armar, Laletha Agoramoorthy, Priscilla Phiri, Shanna Wilson, Stefania Stegner, Theodora Nago and Tim Soete on behalf of the site.
Basildon and Thurrock University Hospitals NHS Foundation Trust: Javaid Subhani (PI), Anne Nicholson, Karen Steggles, Marco Bondoc, Anne Case and Sibongile Gorogodo on behalf of the site.
University Hospitals Bristol NHS Foundation Trust: Tom Creed (PI), Shiney George, Edel Robbins, Jane Bowles, Jennifer Anstey and Nicola Barrah on behalf of the site.
North Bristol NHS Trust: Melanie Lockett (PI), Ann Treasure, Carol Brain, Lisa Lillywhite and Suriya Kirkpatrick on behalf of the site.
Torbay and South Devon NHS Foundation Trust: Rupert Pullan (PI), Sarah Tobin, Natalie Taylor, Kathryn Bird, Kerenza Boulton, Pauline Mercer and Georgina Ayres on behalf of the site.
Plymouth Hospitals NHS Trust: Chris Hayward (PI), Sue Inniss, Ann-Marie Rowe, Judy Sercombe, Tim Johns and Kathryn Bird on behalf of the site.
North West Anglia NHS Foundation Trust (Hinchingbrooke): Phillip Roberts (PI), Julie Maddocks, Lelsey-Anne Exon and Janet Jones on behalf of the site.
North West Anglia NHS Foundation Trust (Peterborough): Naveen Kumar (PI), Julie Maddocks, Lelsey Ann Exon and Janet Jones on behalf of the site.
Royal Cornwall Hospitals NHS Trust: James Bebb (PI), Keely Lane, Benita Adams, Fiona Hammonds, Heidi Duckworth, Helen Anderson, Lisa Trembath, Christine Taylor, Patricia Petrauske and Rebecca Warren on behalf of the site.
Cheltenham General and Gloucestershire Hospitals NHS Foundation Trust: Simon Hellier (PI), Linda Hill, Estelle Nabela, Karen Holbrook, Natalie Bynorth, Paula Townshend, Sarah White, Sophie Delacruz and Christian Loveridge on behalf of the site.
Royal Wolverhampton Hospitals NHS Trust: Matt Brookes (PI), Marie Green, Jayne Rankin and Jill Brown on behalf of the site.
West Hertfordshire Hospitals NHS Trust: Alistair King (PI), Linda Sarginson, Elaine Walker, Olabisi Adeoti and Sarah Cerys on behalf of the site.
Taunton and Somerset NHS Foundation Trust: Paul Thomas (PI), Jayne Foot, Leane Foote, Lucy Brotherton, Gillian Shire, Irene Cruickshank, Kelly Brown, Jennifer Williams, Julia Heneker and Karen Triggs on behalf of the site.
Yeovil District Hospital NHS Foundation Trust: Steve Gore (PI), Katie Spurdle, Alison Lewis, Donna Haywood, Kate Ronaldson, Sarah Board and Suzette David on behalf of the site.
Sherwood Forest Hospitals NHS Foundation Trust: Steve Foley (PI), Terri-Ann Sewell, Cheryl Heeley, Lynne Allsop and Dominic Nash on behalf of the site.
Blackpool Teaching Hospitals NHS Foundation Trust: Mark Hendrickse (PI), Greta Duyvenvoorde, Rachael Wheeldon, Sue Hesketh, Louise Newton, Carly Hollin, Louise Johnson, Lucy Clarkson, Ruth Connelley, Sarah Strickland and Sylvia Taylor on behalf of the site.
Lancashire Teaching Hospital Foundation Trust: Philip Shields (PI), Emma Durant, Ailsa Watt, Alexandra Williams, Janet Mills, Mark Verlander and Louise Newton on behalf of the site.
Colchester Hospital University NHS Foundation Trust: Donagh O’Riordan (PI), Aine Turner, Alison Ghosh, Cathleen Chabo, Marianne Morgan, Natalie Wheatley, Nyasha Nago and Orla Thunder on behalf of the site.
Ipswich Hospital NHS Trust: Simon Williams (PI), Joanne Bradley, Ginny Rose, John Cuckow, Stephanie Bell and Susan Cuckow on behalf of the site.
East and North Hertfordshire NHS Trust: Peter McIntyre (PI), Elizabeth Green, Clare Collins, Nicola McNiff, Poppa de Sousa and Roisin Schimmel on behalf of the site.
University Hospital Southampton NHS Foundation Trust: Phil Boger (PI), Emma Levell and Janet Jones on behalf of the site.

Contributions of authors

Mark A Hull (Professor of Molecular Gastroenterology and Honorary Consultant Gastroenterologist) was the Chief Investigator and authored the final report.

Kirsty Sprange (Trial Manager and Senior Trial Manager) oversaw trial delivery and contributed to the final report.

Trish Hepburn (Senior Medical Statistician) oversaw the statistical analysis and contributed to the final report.

Wei Tan (Medical Statistician, NCTU) performed the statistical analysis and contributed to the final report.

Aisha Shafayat (Trial Manager, NCTU) oversaw the trial and contributed to the final report.

Colin J Rees (Professor of Gastroenterology and Consultant Gastroenterologist) contributed to the trial design and delivery, and to the final report.

Gayle Clifford (BCSP SSPr) contributed to the trial design and the final report.

Richard F Logan (Professor of Epidemiology) contributed to the trial design and delivery, and to the final report.

Paul M Loadman (Professor of Pharmacokinetics and Drug Metabolism) contributed to the trial delivery, led the trial biobank and contributed to the final report.

Elizabeth A Williams (Senior Lecturer in Human Nutrition) contributed to the FFQ analysis and to the final report.

Diane Whitham (Research Manager) contributed to the trial design and delivery, and to the final report.

Alan A Montgomery (Professor of Medical Statistics and Clinical Trials) oversaw the statistical analysis and contributed to the final report.

Publications

Hull MA, Sandell AC, Montgomery AA, Logan RF, Clifford GM, Rees CJ, et al. A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (the seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial. Trials 2013;14:237.

Hull MA, Sprange K, Hepburn T, Tan W, Shafayat A, Rees CJ, et al. Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial. Lancet 2018;392:2583–94.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research. 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 MRC, NETSCC, the EME 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, NETSCC, the EME programme or the Department of Health and Social Care.

Attribution. Mark A Hull; Kirsty Sprange; Trish Hepburn; Wei Tan; Aisha Shafayat; Colin J Rees et al. (2019). Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT. NIHR Journals Library. Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Hull et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Licensed under CC BY 4.0. NCBI Bookshelf NBK543177. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.