Contributions of authors
Karen Innes (https://orcid.org/0000-0001-8512-4368) (Trial Manager) contributed to the design of the trial, was responsible for the day-to-day management of the trial and contributed to the interpretation of results and writing/editing the report.
Irfan Ahmed (https://orcid.org/0000-0002-2172-4177) (Co-Chief Investigator, Professor) contributed to the conception and design of the trial, was involved in recruitment, recruited, and was responsible for the day-to-day oversight of the trial, interpretation of results and writing/editing the report.
Jemma Hudson (https://orcid.org/0000-0002-6440-6419) (Statistician) conducted the statistical analysis and contributed to the interpretation of results, writing/editing the report and reviewing the final report.
Rodolfo Hernández (https://orcid.org/0000-0003-2619-8230) (Health Economist) contributed to the conception and design of the study, the analysis of the health economics data, the development of the health economics model, the drafting of the health economics chapters, the interpretation of the trial results, plus commented on other chapters of the report.
Katie Gillies (https://orcid.org/0000-0001-7890-2854) (Qualitative Researcher) contributed to the conception and design of the trial, oversaw the process evaluation and core outcome set development and analysis, contributed to the interpretation of results and writing/editing the report.
Rebecca Bruce (https://orcid.org/0000-0001-8508-1206) (Data Co-ordinator) was responsible for aspects of the day-to-day management of the trial and contributed to the interpretation of results and editing the report.
Victoria Bell (https://orcid.org/0000-0001-9518-9296) (Assistant Trial Manager) was responsible for aspects of the day-to-day management of the trial and contributed to the interpretation of results and writing/editing the report.
Alison Avenell (https://orcid.org/0000-0003-4813-5628) (Clinical Chair in Health Services Research) contributed to the conception and design of the trial, the interpretation of results and writing/editing the report.
Jane Blazeby (https://orcid.org/0000-0002-3354-3330) (Professor of Surgery) contributed to the design of the trial, conduct of the trial, interpretation of results and writing/editing the report.
Miriam Brazzelli (https://orcid.org/0000-0002-7576-6751) (Senior Research Fellow) contributed to the conception and design of the trial, the interpretation of results and writing/editing the report.
Seonaidh Cotton (https://orcid.org/0000-0002-7883-0608) (Senior Trail Manager) contributed to oversight of the day-to-day management of the trial and contributed to the interpretation of results and writing/editing the report.
Bernard Croal (https://orcid.org/0000-0002-6375-3507) (Patient and Public Representative) as a named grant holder, contributed to the conception and design of the trial, conduct of the trial, recruitment and follow-up of participants, interpretation of results and writing/editing the report. He also focused on the patient and public involvement (PPI) components of the trial which fed important information back to the trial.
Mark Forrest (https://orcid.org/0000-0002-2395-8823) (Senior IT Development Manager) contributed to the design of the trial software and data curation, interpretation of results and writing/editing the report.
Graeme MacLennan (https://orcid.org/0000-0002-1039-5646) (CHaRT Director) contributed to the statistical analysis, the interpretation of results and writing/editing the report.
Peter Murchie (https://orcid.org/0000-0001-9968-5991) (Academic GP) contributed to the conception and design of the trial, the interpretation of results and writing/editing the report.
Samantha Wileman (https://orcid.org/0000-0002-1031-1449) (Quality Assurance Manager) contributed to the conception and design of the trial, the interpretation of results and writing/editing the report.
Craig Ramsey (https://orcid.org/0000-0003-4043-7349) (Co-Chief Investigator, Professor) contributed to the conception and design of the trial, was responsible for the day-to-day oversight of the trial, interpretation of results and writing/editing the report.
Acknowledgements
The authors wish to thank the men and women who participated in C-GALL. We also thank the CHaRT data co-ordinators and trial managers who helped support the study: Zoe Batham, Louise Campbell, Janice Cruden, Dianne Dejean, Jackie Ellington, Andrea Fraser and Bev Smith (Data Co-ordinators), Tracey Davidson and Alison McDonald (Trial Managers).
We are grateful to Kirsty McCormack and John Norrie for their help and advice in developing the grant proposal, to the Programming Team in CHaRT for developing and maintaining the study website. We thank Juliette Snow and Rachael West for their help with contracting, and Louise Cotterell, Kerry Duffus and Anne Buckle for their assistance in managing the budget. Our thanks also go to the Research Governance team (Louise King, Stacey Dawson, Lynn McKay) at the University of Aberdeen for their advice and support during the study.
Thanks to Jamie McAllister (NHS Grampian) for providing unit cost data for the within-trial economic analysis.
Thanks to Chen et al. for allowing the C-GALL group the use of the Otago Condition-Specific Questionnaire (OCSQ) for gallstone disease, developed by Chen et al. in the University of Otago, New Zealand.1,2
1. Chen TY, Landmann MG, Potter JC, van Rij AM. Questionnaire to aid priority and outcomes assessment in gallstone disease. ANZ J Surg. 2006;76(7):569–74.
2. Chen TY. A novel set of condition-specific quality of life questionnaires in elective general surgical patient prioritization and outcome assessment [dissertation]. Dunedin (NZ): University of Otago; 2012. Retrieved from http://hdl.handle.net/10523/2588
Members of the PMG for their ongoing support and advice. The independent members of the TSC and DMC, and the staff at the recruiting sites (listed below) who facilitated recruitment, treatment and follow-up of trial participants.
Project Management Group
Craig Ramsay, Irfan Ahmed, Alison Avenell, Victoria Bell, Jane Blazeby, Miriam Brazzelli, Rebecca Bruce, Bernard Croal (Grant Holder PPI Representative), Mark Forrest, Katie Gillies, Rodolfo Hernandez, Jemma Hudson, Karen Innes, Graeme MacLennan, Peter Murchie, John Norrie, Samantha Wileman.
Trial Steering Group
David Beard (Chair), Ian Beckingham (Independent Member), John Leeds (Independent Member TSC), Dee McDonald (Patient Representative) and PMG members.
Data Monitoring Committee
Catherine Hewitt (Chair), Jonathan Lund (Independent Member), Tim McAdam (Independent Member) and Amir Nisar (Independent Member).
Embedded Process Evaluation Team
Eilidh Duncan, Jennifer Dunsmore, Louisa Lawrie, Rumana Newlands.
Core Outcome Set Team
Mohammed Bekheit, Moira Cruickshank.
Patient and Public Involvement (PPI) group
Special thanks to those who participated in the PPI group: Edna Bell, Anna Glassey, Denise Gorman, Carolyn Hutchison, Marion Morton, Alec Paterson, Sheena Rendall, Wendy Stuart, Annamaria Wolf and to Katie Banister for her involvement in the PPI activities.
Members of the C-GALL trial group responsible for recruitment in the clinical centres were as follows:
Aberdeen: James Milburn (Principal Investigator), Irfan Ahmed (Principal Investigator), Momin Malik, Sandra Mann, Amy Nicol (Nee – Angus), Tracy Scott, Lorna Van Lierop
Bedford: Dipankar Chattopadhyay (Principal Investigator), Beena David, Carina Galpin, Mel Penacerrada, Kanapathi Rajaratnam, Retno Walandari
Birmingham: Robert Sutcliffe (Principal Investigator), Elizabeth Cornes, Sharon Garner, Manijeh Ghods, Ewen Griffiths, Ravi Marudanayagam, Andrew McDarby, Claire McNeill, Sonia Puig-Compano, Keith Roberts, Arlo Whitehouse
Borders: Jamie Young (Principal Investigator), Joy Dawson, Dave Gribble, Laura Stephen
Cardiff: David O’Reilly (Principal Investigator), Rezwana Chowdhury, Antonio Foliaki, Martin Grigg, Laura Jones, Lucy Knibbs, Gail Williams, Jolene Witherspoon, Caroline Young
Coventry: Jawad Ahmad (Principal Investigator), Susan Dale, Natalie Kenny, Edward Lopez, Gabriele Marangoni
Durham: Zaher Toumi (Principal Investigator), Sarah Clark, Louise Duncan, Stef Hobson, Andrea Kay, Ami Laidlaw, Diana Nayman, Ami Wilkinson
Fife: Peter Driscoll (Principal Investigator), Karlygash Ausel, Laura Beveridge, Keith Boath, Geert Koffeman, Sue Pick
Glasgow: Simon Gibson (Principal Investigator), Anissa Benchiheub, Carol Dalton, Paul Glen, Steven Henderson, Gillian Rice
Heart of England: Markos Daskalakis (Principal Investigator), Sally Abbott, Safia Begum, Maryam Hussain, Tabinda Kharodia, Julie Markley, Faye Moore, Raj Nijjar, VJ Shabangu, Karim Sillah, Rishi Singhal, Samantha Stafford, Paul Super, Olga Tucker
Liverpool: Christopher Halloran (Principal Investigator), Lorna Fleming-Bird, Julie Haydock, Francesca Westwell
Newport: Andrew Beamish (Principal Investigator), Michael Nutt (Principal Investigator), Ashraf Rasheed (Principal Investigator), Lindianne Aitken, Evelyn Baker, Nancy Hawkings, Georgia Mallison, Heeam Nassa, Grace Okoro, Claire Price, Sandapa Punchihewa, Laura Smith, Jemma Tuffney, Elaine Wall, Cerian Williams
North Tees: Talvinder Gill (Principal Investigator), Mazuin Abutalib, Ish Ahmed, Rajendirin Ashwin, Liz Baker, Leo Brown, Bussa Gopinath, Deena Harji, Siddek Isreb, Aya Musbahi, Milind Rao, Murugappan Shanmugam, Kyaw Toe, Suvi Virupaksha, Debbie Wilson
Nottingham: Ravinder Vohra (Principal Investigator), Tracy Brear, Debra Campion, Jody Carvell, James Catton, David Chadwick, Sam Dutta, Tanvir Hossain, Maria Laye, Kate Marks, Simon Parsons, Shirley Pyke, Judith Rozentals, John Saunders, Nilanjana Tewari, Rhian Warman, Neil Welch, Fady Yanni
Plymouth: David Stell (Principal Investigator), Abigail Patrick, Aleasha Udal, Natasha Wilmshurst
Royal Free: Brian Davidson (Principal Investigator), Christine Eastgate, Helder Filipe, Yvonne Gleeson, Kurinchi Gurusamy
Sandwell: Andrew Torrance (Principal Investigator), Veronica Campbel, Julie Colley, Mokhtar Eltair, Samia Hussain, Yogesh Kumar, Rajnish Mankotia, Jenny Porter, Liam Preece, Elizabeth Williams
Taunton: Marianne Hollyman (Principal Investigator), Sarah Brown, Katrina Butcher, Viktoria Cripps, Rebecca Goodchild, Libby Graham, Ami Mackay, Matthew Mason, Peter Mekhail, Alison Moss, Hamish Noble, Maria O’Leary, Corinne Pawley, Andrew Robertson, Charmaine Shovelton, Muwaffaq Telfah, Frances Venn, Richard Welbourn, Esther Zebracki
Warwick: Paul Marriott (Principal Investigator), Indy Atwal, Bridget Campbell, Vasileios Charalampakis, Angela Day, Angela Doyle, Sophie Mason, Penny Parsons, Alexandra Smith, Karen Spicer, Frances Walsh, Kathryn Webb
Yeovil: John Spearman (Principal Investigator), Joanna Allison, Kate Beesley, Nathan Curtis, Godwin Dennison, Linda Howard, Alison Lewis, Jess Perry
Sites opened but never recruited
Aintree: Hassan Malik (Principal Investigator), Matthew Caffrey, Shirley Cooper, Rafael Diaz-Nieto, Declan Dunne, Joanne Earley, Stephen Fenwick, Melanie Harrison, Tanya Ingram, Robert Jones, Sophie Marsh, Sarah Stevenson, Cath Toohey
Dundee: Iain Tait (Principal Investigator), Mairead Tennent
Patient data statement
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 they are 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
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to available anonymised data may be granted following review.
Ethics statement
C-GALL received favourable ethics opinion from North of Scotland Research Ethics Committee (REC) A, on 23 May 2016 (REC reference number 16/NS/0053).
Information governance statement
The University of Aberdeen and NHS Grampian are 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 Aberdeen and NHS Grampian are joint Data Controllers, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here: https://www.abdn.ac.uk/about/privacy/
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/MNBY3104.
Primary conflicts of interest: Katie Gillies reports other financial or no financial interest as a member of the NIHR HTA CET Committee since 2020; Jane Blazeby reports grants from NIHR Bristol Biomedical Research Centre and being a member of the NIHR Clinical Trials Unit Standing Advisory Committee 2015–9; Seonaidh Cotton is a coinvestigator on unrelated grants from NIHR (HTA and EME programmes: NIHR129819, 15/130/95, 15/130/20) for which her institution has received payment; Bernard Croal reports a Leadership or fiduciary role in the Association of Clinical Biochemistry and Laboratory medicine as president 2021–2023 and Royal College of Pathologists as Trustee and Scottish Chair; Craig Ramsay reports no financial interest as a member of the NIHR HTA General Committee 2017–22.
Additional funding
Chapter 7 – Core Outcome Set: This work was also supported by NHS Grampian Endowment (project grant no. 16/11/006). KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1).
Publications
Tunji-Ajayi P, Duncan EM, Gillies K. An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations. J Clin Epidemiol. 2020;123:49–58. https://doi.org/10.1016/j.jclinepi.2020.03.011
Ahmed A, Innes K, Brazzelli M, et al. Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-GALL trial). BMJ Open 2021;11:e039781.
Cruickshank M, Newlands R, Blazeby J, et al. Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set. BMJ Open 2021;11:e045568.
Lawrie L, Duncan EM, Dunsmore J, et al. Using a behavioural approach to explore the factors that affect questionnaire return within a clinical trial: a qualitative study based on the theoretical domains framework. BMJ Open 2021;11:e048128. https://doi.org/10.1136/bmjopen-2020-048128
Innes K, Hudson J, Banister K, et al. Core outcome set for symptomatic uncomplicated gallstone disease. Br J Surg 2022;109:539–44. https://doi.org/10.1093/bjs/znac095
Disclaimers
This article 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.