This trial was designed and delivered in collaboration with the BTC, a UK Clinical Research Collaboration-registered Clinical Trials Unit in receipt of NIHR Clinical Trials Unit support funding. The University of Bristol acted as the sponsor for this trial and the trial was hosted by the NHS Bristol, North Somerset and South Gloucestershire CCG. The TRIUMPH trial research team acknowledges the support of the NIHR CRN.
Trial data were collected and managed using REDCap electronic data capture tools hosted at the University of Bristol.68,69 REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture, (2) audit trails for tracking data manipulation and export procedures, (3) automated export procedures for seamless data downloads to common statistical packages and (4) procedures for data integration and interoperability with external sources.
The authors would like to thank all participants, principal investigators and their teams at each of the TRIUMPH trial sites for their involvement, and the West of England and Wessex CRNs for their role in the trial, in particular the CRN staff who conducted the TRIUMPH trial patient screening calls. The authors would also like to thank the members of the Trial Steering Committee and the Data Monitoring Committee.
TRIUMPH study group
- Chief investigator: Marcus Drake.
- Trial managers: Jo Worthington and Jessica Frost.
- BRTC co-director (Bristol Trials Centre): Athene Lane.
- Senior trial manager: Jodi Taylor.
- Trial statisticians: Emily Sanderson and Stephanie MacNeill.
- Trial research nurses: Samantha Clarke, Joanne Thompson, Margaret Macaulay, Miriam Avery, Jackie Broadbridge and Pauline Rachman.
- Qualitative researchers: Nikki Cotterill and Jessica Wheeler.
- Health economists: Sian Noble, Madeleine Cochrane and Caoimhe Rice.
- Administrative support: Charlotte McDonald, Nicholas Christoforou and Aneta Taylor.
- Data management: David Carmichael.
Trial sites and principal investigators
| General practice | Principal investigator |
|---|---|
| Portishead Medical Group | Dr Matthew J Ridd |
| West Walk Surgery | Dr Sam Davies |
| Tyntesfield Medical Group | Dr Jonathan Rees |
| Nightingale Valley Practice | Dr Katharine Alsop |
| Kingswood Health Centre | Dr Helen Stoddart/Dr Alex Hickson |
| Mendip Vale Medical Practice | Dr Richard Reed |
| Clevedon Medical Centre | Dr Matthew Hoghton |
| Pioneer Medical Group | Dr Susie Cary |
| Lansdowne Surgery | Dr Nicholas Swale |
| Rowden Surgery | Dr Richard Gaunt |
| The Family Practice | Dr James Baker |
| Pembroke Road Surgery | Dr Rohan Perera |
| Whiteladies Medical Group | Dr Steve Granier |
| Heart of Bath Medical Partnership | Dr Tim Johnson |
| Portland Practice | Dr Shane Hegingbotham |
| Hathaway Medical Centre | Dr Philip Grimmer |
| Phoenix Health Group | Dr Naomi Vernon |
| Trowbridge Health Centre | Dr Tobias Cookson |
| Wareham Surgery | Dr Nathan Francis |
| The Adam Practice | Dr Patrick Moore |
| Swan Medical Group | Dr Rajdeep Laly |
| Abbeywell Surgery | Dr Tracey Ryan |
| Andover Health Centre | Dr Lucy Allen |
| The Friarsgate Practice | Dr Stephen Fowler |
| Highcliffe Medical Centre | Dr Zelda Cheng |
| Three Chequers Medical Practice | Dr Craig Kyte |
| Gosport Medical Centre | Dr Bozena Gorecka |
| Cowplain Family Practice | Dr Nicola Millen |
| Gillingham Medical Practice | Dr William Fenton |
| Homewell Curlew Practice | Dr Helen Whiting |
| The Wilson Practice | Dr Oliver Kemp |
| Salisbury Medical Practice | Dr Polly Jacobs |
Trial oversight committees
We thank all the members of the trial oversight committees for their valued contributions.
TRIUMPH Trial Steering Committee
Professor Peter Bower (chairperson), Professor Siobhan Creanor, Mr Malcom Pick and Mr Mark Speakman.
TRIUMPH Data Monitoring and Ethics Committee
Mr Chris Harding (chairperson), Professor Suzanne Richards and Dr Jennifer Nicholas.
Trial Management Group
Marcus Drake, Jo Worthington, Jessica Frost, Stephanie MacNeill, Sian Noble, Margaret Macaulay, Emily Sanderson, Luke Robles, Athene Lane, Hashim Hashim, Gordon Taylor, Nikki Cotterill, Jodi Taylor, Matthew J Ridd, Madeleine Cochrane, Lucy McGeagh, Jon Rees, Mandy Fader, Jess Wheeler, Miriam Avery, Jo Thompson and Sam Clarke.
Contributions of authors
Jo Worthington (https://orcid.org/0000-0002-2860-3511) (Trial Manager) managed the co-ordination of the trial throughout, and contributed to aspects of trial design, development of the trial protocol and procedures, and to writing the report.
Jessica Frost (https://orcid.org/0000-0002-2454-311X) (Trial Manager) managed the co-ordination of the trial throughout, and contributed to aspects of trial design, development of the trial protocol and procedures, and to writing the report.
Emily Sanderson (https://orcid.org/0000-0003-2268-4194) (Research Associate, medical statistics) conducted the statistical analysis and contributed to writing the report.
Madeleine Cochrane (https://orcid.org/0000-0003-1856-3293) (Research Associate, health economics) conducted the analysis of the economic evaluation and contributed to writing the report.
Jessica Wheeler (https://orcid.org/0000-0003-0802-7286) (Senior Research Associate in qualitative research) conducted the qualitative study and contributed to writing the report.
Nikki Cotterill (https://orcid.org/0000-0001-6921-2712) (Associate Professor in continence care) was a co-applicant and the lead qualitative researcher on the trial, was involved in designing and managing the qualitative analysis and contributed to writing the report.
Stephanie J MacNeill (https://orcid.org/0000-0001-6553-1433) (Senior Lecturer in medical statistics) was a co-applicant and the lead statistician for the trial, was involved in trial design and in managing the statistical analysis and contributed to writing the report.
Sian Noble (https://orcid.org/0000-0002-8011-0722) (Senior Lecturer, health economics) was a co-applicant and the lead health economist for the trial; was involved in designing, managing and conducting the health economic evaluation; and contributed to writing the report.
Miriam Avery (https://orcid.org/0000-0001-7772-9412) (Research Nurse) delivered the TRIUMPH intervention in the Wessex hub and was a member of the Trial Management Group.
Samantha Clarke (https://orcid.org/0000-0002-3100-3111) (Lead Urology Research Nurse) was lead research nurse in the West of England for the trial, and was a member of the Trial Management Group.
Mandy Fader (https://orcid.org/0000-0002-0801-543X) (Professor of Continence Technology) was a co-applicant, and contributed to the trial design and oversight of the trial in the Wessex hub.
Hashim Hashim (https://orcid.org/0000-0003-2467-407X) (Professor, Consultant Urological Surgeon) was a co-applicant, and contributed to the trial design and oversight of the trial.
Lucy McGeagh (https://orcid.org/0000-0002-9226-5115) (Senior Research Associate in Cancer, Chartered Psychologist) was a co-applicant providing expertise on the behavioural aspects of the trial, and contributed to the trial design and oversight of the trial.
Margaret Macaulay (https://orcid.org/0000-0003-1737-4589) (Senior Research Nurse) supported the set-up and recruitment of primary care sites, managed and delivered the TRIUMPH intervention in the Wessex hub, and contributed to oversight of the trial.
Jonathan Rees (https://orcid.org/0000-0001-8014-4407) (general practitioner partner) was a co-applicant providing primary care expertise, contributed to the trial design and oversight of the trial, and was a principal investigator for his trial site.
Luke Robles (https://orcid.org/0000-0003-2882-9868) (Senior Research Associate in Cancer) was a co-applicant providing expertise on the behavioural aspects of the trial, and contributed to the trial design and oversight of the trial.
Gordon Taylor (https://orcid.org/0000-0002-8029-2503) (PPI representative) was a co-applicant providing a patient perspective, contributed to the trial design and oversight of the trial and took a leading role in wider patient advisory group meetings.
Jodi Taylor (https://orcid.org/0000-0001-7171-8923) (Head of Trial Management and Operations) contributed to trial co-ordination and oversight of the trial and to writing the report.
Joanne Thompson (https://orcid.org/0000-0001-6598-3085) (Research Nurse) delivered the TRIUMPH intervention in the West of England hub and was a member of the Trial Management Group.
J Athene Lane (https://orcid.org/0000-0002-7578-4925) (Professor of Trials Research) was a co-applicant, contributed to the trial design, was involved in management of the trial and contributed to writing the report.
Matthew J Ridd (https://orcid.org/0000-0002-7954-8823) (Reader in Primary Health Care, general practitioner) was a co-applicant providing primary care expertise, contributed to the trial design and oversight of the trial, and was a Principal Investigator for his study site.
Marcus J Drake (https://orcid.org/0000-0002-6230-2552) (Professor of Physiological Urology, Associate Director of Research for the Bristol NHS Hospital Trusts) was chief investigator and clinical lead for the trial, and, as such, conceived the trial, participated in its design and co-ordination, and contributed to writing the report.
All authors read and approved and/or commented on the final report.
Publications
Frost J, Lane JA, Cotterill N, Fader M, Hackshaw-McGeagh L, Hashim H, et al. TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial. Trials 2019;20:546.
Worthington J, Frost J, Lane JA, Robles L, Rees J, Taylor G, et al. Effective management of male lower urinary tract symptoms in primary care. Br J Gen Pract 2021;71:388–9.
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 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.
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.