Members of the GaPP2 collaborative group
Co-investigators
Andrew Baranowski, University College London, London, UK.
Siladitya Bhattacharya, University of Aberdeen, Aberdeen, UK.
Judy Birch (Patient Advisor), PPSN.
Ying C Cheong, University of Southampton, Southampton, UK.
Roman Cregg, University College London, London, UK.
Jane P Daniels, University of Nottingham, Nottingham, UK.
Gary J McFarlane, University of Aberdeen, Aberdeen, UK.
Lee J Middleton, University of Birmingham, Birmingham, UK.
Irene Tracey, University of Oxford, Oxford, UK.
Amanda C de C Williams, University College London, London, UK.
Krina Zondervan, University of Oxford, Oxford, UK.
Trial Management Group
Andrew W Horne (Chairperson), Chief Investigator, University of Edinburgh, Edinburgh, UK.
Katy Vincent, Co-investigator, University of Oxford, Oxford, UK.
Jane P Daniels, Co-investigator, University of Nottingham, Nottingham, UK.
Catherine A Hewitt, Statistician, University of Birmingham, Birmingham, UK.
Lee J Middleton, Senior Statistician, University of Birmingham, Birmingham, UK.
Ann M Doust, Research Manager, University of Edinburgh, Edinburgh, UK.
Magda Koscielniak, Trial Manager, University of Edinburgh, Edinburgh, UK.
Afia Sajid, Trial Co-ordinator, University of Birmingham, Birmingham, UK (from 1 August 2015 to 1 August 2017).
Lisa J Leighton, Trial Co-ordinator, University of Birmingham, Birmingham, UK (from 1 August 2017 to 19 November 2018).
Smita Odedra, Trial Co-ordinator, University of Birmingham, Birmingham (from 19 November 2018 to 31 July 2019).
Max G Feltham, Team Lead, BCTU, University of Birmingham, Birmingham, UK.
Clive Stubbs, Team Lead, BCTU, University of Birmingham, Birmingham, UK.
Principal investigators and recruiting sites
Lucky Saraswat, Aberdeen Royal Infirmary, Aberdeen, UK.
Tunde D Dada, Stoke Mandeville Hospital, Aylesbury, UK.
Pratima Gupta, Birmingham Heartlands Hospital, Birmingham, UK.
Justin Clark, Birmingham Women’s Hospital, Birmingham, UK.
William Rea, University Hospital Birmingham, Birmingham, UK.
Kalsang Bhatia, Burnley General Hospital, Burnley, UK.
Simon Wood, Countess of Chester Hospital, Chester, UK.
Ajay Swaminathan, Leighton Hospital, Crewe, UK.
Jambulingam Sivasamy, Darlington Memorial Hospital, Darlington, UK.
Andrew W Horne, Royal Infirmary of Edinburgh, Edinburgh, UK.
Chris Hardwick, Queen Elizabeth University Hospital, Glasgow, UK.
Rashmi Srivastava, Raigmore Hospital, Inverness, UK.
Santanu Acharya, University Hospital Crosshouse, Kilmarnock, UK.
Omar Thanoon, Victoria Hospital, Kirkcaldy, UK.
Dharani Hapangama, University of Liverpool, Liverpool, UK.
Nadia Bhal, Royal Glamorgan Hospital, Llantrisant, UK.
Amer Raza, Chelsea and Westminster Healthcare NHS Trust, London, UK.
Elizabeth Ball, The Royal London Hospital, London, UK.
Roman Cregg, University College Hospital, London, UK.
Suraiya Abdi, West Middlesex University Hospital, London, UK.
Kingshuk Majumder, St Mary’s Hospital, Manchester, UK.
Pinky Khatri, The James Cook University Hospital, Middlesbrough, UK.
Premila Thampi, Milton Keynes University Hospital, Milton Keynes, UK.
Tony Chalhoub, The Royal Victoria Infirmary, Newcastle upon Tyne, UK.
Somendra Roy, University Hospital of North Tees, North Tees, UK.
Katy Vincent, John Radcliffe Hospital, Oxford, UK.
Bruce Ramsay, Peterborough City Hospital, Peterborough, UK.
Tyrone Carpenter, Poole General Hospital, Poole, UK.
Radwan Faraj, Rotherham General Hospital, Rotherham, UK.
Shamma Al-Inizi, South Tyneside District General Hospital, South Tyneside, UK.
Ying Cheong, Faculty of Medicine Institution, Southampton, UK.
Alex Mortimer, Sunderland Royal Hospital, Sunderland, UK.
Martyn Underwood, The Princess Royal Hospital, Telford, UK.
Dib Datta, Maidstone and Tunbridge Wells NHS Trust, Tunbridge Wells, UK.
Tony Thomas, Manor Hospital, Walsall, UK.
Clare Willocks, University Hospital of Wishaw, Wishaw, UK.
Jon Hughes, Worcestershire Royal Hospital, Worcester, UK.
Geeta Kumar, Wrexham Maelor Hospital, Wrexham, UK.
Ahmar Shah, Yeovil District Hospital, Yeovil, UK.
We thank the clinical research nurses and midwives for their outstanding contribution to recruitment, randomisation and collection of the data.
Trial Steering Committee
Patrick Chien (Chairperson), Ninewells Hospital, Dundee, UK.
Alaine Delve (Patient Advisor), Pelvic Pain Support Network.
John J Hughes, James Cook University Hospital, South Tees, UK.
Mostafa Metwally, University of Sheffield, Sheffield, UK.
Jim G Thornton, University of Nottingham, Nottingham, UK (Chairperson from 19 June 2015 to 1 April 2017).
Data and Safety Monitoring Committee
Mary Ann Lumsden (Chairperson), University of Glasgow, Glasgow, UK.
George R Harrison, Birmingham Women’s Hospital, Birmingham, UK.
Nicola Williams, University of Oxford, Oxford, UK.
Mechanistic study team
Katy Vincent, University of Oxford, Oxford, UK.
Liana Romaniuk, University of Edinburgh, Edinburgh, UK.
Heather Whalley, University of Edinburgh, Edinburgh, UK.
Wojciech Szubert, University of Edinburgh, Edinburgh, UK.
Scott Semple, University of Edinburgh, Edinburgh, UK.
Priscilla Fernandez, University of Edinburgh, Edinburgh, UK.
Radiographers at the Clinical Research Imaging Centre.
Sponsor
The sponsor was ACCORD – NHS Lothian and University of Edinburgh.
Monitoring and Audit Team led by Elizabeth Craig and Lorn MacKenzie.
Contributions of authors
Catherine A Hewitt (https://orcid.org/0000-0002-0473-0532) (Trial Statistician) performed the analyses for the trial, contributed to the interpretation of the trial and the drafting of the report.
Katy Vincent (https://orcid.org/0000-0001-9249-2492) (Associate Professor, Senior Pain Fellow in Women and Honorary Consultant Gynaecologist) contributed to the design, delivery, analysis and interpretation of all components of GaPP2, and the editing of the final report.
Lee J Middleton (https://orcid.org/0000-0003-4621-1922) (Senior Statistician) contributed to the design of GaPP2, contributed to the interpretation of the trial and the drafting of the report.
Liana Romaniuk (https://orcid.org/0000-0002-3823-8052) (Clinical Lecturer in Child and Adolescent Psychiatry) contributed to the design (mechanistic study), analysis and interpretation of the fMRI study.
Magda Koscielniak (https://orcid.org/0000-0003-0605-3368) (Trial Manager) was responsible for the day-to-day management, delivery of the trial, drafting the report and overall editing of the final report.
Ann M Doust (https://orcid.org/0000-0001-8726-7186) (Research Manager) contributed to the design of GaPP2, was responsible for the day-to-day management and delivery of the trial, contributed to drafting the report and overall editing of the final report.
Judy Birch (https://orcid.org/0000-0003-3911-2627) (Chief Executive of Pelvic Pain Support Network) contributed to the design and interpretation of the trial, and led on patient and public involvement contributions.
Heather Whalley (https://orcid.org/0000-0002-4505-8869) (Senior Clinical Research Fellow) contributed to the design of GaPP2 (mechanistic study), analysis and interpretation of the fMRI study.
Jane P Daniels (https://orcid.org/0000-0003-3324-6771) (Professor of Clinical Trials) contributed to the design, delivery and interpretation of the trial and editing of the final report.
Andrew W Horne (https://orcid.org/0000-0002-9656-493X) (Professor of Gynaecology and Reproductive Sciences and Chief Investigator) contributed to the design, delivery, analysis and interpretation of all components of GaPP2, the first draft and overall editing of the final report.
Publications
Horne AW, Vincent K, Cregg R, Daniels J. Is gabapentin effective for women with unexplained chronic pelvic pain? BMJ 2017;358:j3520.
Vincent K, Baranowski A, Bhattacharya S, Birch J, Cheong Y, Cregg R, et al. GaPP2, a multicentre randomised controlled trial of the efficacy of gabapentin for the management of chronic pelvic pain in women: study protocol. BMJ Open 2018;8:e014924.
Horne AW, Vincent K, Hewitt CA, Middleton LJ, Koscielniak M, Szubert W, et al. Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2020;396:909–17.
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 are 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 is 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.