@article{1fed25ff755a488394914f09889595a5,
title = "Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis",
abstract = "Background: Bulbar urethral stricture is a common cause for urinary symptoms in men and its two main treatment options both have drawbacks with little evidence on their relative cost-effectiveness. Current guidelines on the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel consensus.Objective: To assess the relative cost-effectiveness of open urethroplasty and endoscopic urethrotomy as treatment for recurrent urethral stricture in men.Methods: Set in the UK National Health Service with recruitment from 38 hospital sites, a randomised controlled trial of open urethroplasty and endoscopic urethrotomy with 6-monthly follow-up over 24 months was conducted. Two hundred and twentytwo men requiring operative treatment for recurrence of bulbar urethral stricture and having had at least one previous intervention for stricture were recruited. Effectiveness was measured by quality- adjusted life years (QALYs) derived from EQ-5D 5L. Cost-effectiveness was measured by the incremental cost per QALY gained over 24 months using a within trial analysis and a Markov model with a 10-year time horizon.Results: In the within trial, urethroplasty cost on average more than urethrotomy (cost difference: £2148 [95% CI: 689, 3606]) and resulted in a similar number of QALYs on average (QALY difference: -0.01 [95% CI: -0.17, 0.14)] over 24 months. The Markov model produced similar results. Sensitivity analyses using multiple imputation, suggested that the results were robust, despite observed missing data.Conclusions: Based on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty",
keywords = "Cost-effectiveness, Economic model, Randomised controlled trial, Urethral stricture, Urethroplasty, Urethrotomy",
author = "Jing Shen and Luke Vale and Beatriz Goulao and Paul Whybrow and Stephen Payne and Nick Watkin",
note = "Funding: Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research, ref: 10/57/23. Acknowledgements: Contributors: Jing Shen, supervised by Luke Vale, led the health economic evaluation and analysis. Robert Pickard led the study, Beatriz Goulao supervised by Graeme MacLennan performed the statistical analysis, Sonya Carnell and Rebecca Forbes supported by Stephanie Currer and supervised by Jennifer Wilkinson managed the trial. John Norrie contributed to the funding application and statistical analysis plan. He also provided support to the statistical analysis team. Matt Breckons, supervised by Jing Shen, conducted a time trade off experiment reported separately. Paul Whybrow, supervised by Tim Rapley, carried out the qualitative research reported separately. Mark Forrest managed and maintained the trial database. Elaine McColl contributed to the funding application and protocol. Daniela Andrich, Anthony Mundy, James N{\textquoteright}Dow and Stephen Payne provided clinician support to the funding application, acted as PIs at key sites. Stewart Barclay contributed a patient view to the trial, including the funding application, the protocol, and all aspects of the analysis. Jonathan Cook was involved in the design of the study and Nick Watkin co-wrote the funding application, contributed clinical insight to the trial management group. We thank the patients and health-care professionals for their participation in the study; Stewart Barclay, the patient and service user representative in the OPEN Trial Management Group; the Trial Steering committee members: Roger Kockelburg (chairperson), John Matthews, Alan McNeil, Howard Kynaston and Neil Campling; Data Monitoring Committee members: Gordon Murray (chairperson), Richard Martin and Thomas Pinkney. We also thank the following people who worked on the trial: Matthew Jackson, Research Fellow; Gladys McPherson, Data Manager; Lee Munro, Trial Manager; Rachel Stephenson, Trial Manager; Sue Tremble, Trial Manager; Robbie Brown, Trial Manager; Mark Deverill, Health Economist; Amy Collins, Project Secretary; Lavinia Miceli, Project Secretary; and Ann Payne, Project Secretary. Members of the Open Trial Group responsible for recruitment and who acted as principle investigators for their centres were: Trevor Dorkin, Freeman Hospital, Newcastle; Nick Watkin, St George{\textquoteright}s Hospital, London; Anthony Mundy, University College London Hospitals NHS Foundation Trust, London; Paul Anderson, Russells Hall Hospital, Dudley; Suzie Venn, Queen Alexandra Hospital, Portsmouth; Ian Eardley, St James{\textquoteright}s University Hospital, Leeds; Mr David Dickerson, Weston General Hospital, Westonsuper-Mare; Nikesh Thiruchelvam, Addenbrooke{\textquoteright}s Hospital, Cambridge; Richard Inman and Chris Chapple, Royal Hallamshire Hospital, Sheeld; Andrew Baird, Aintree University Hospital NHS Foundation Trust, Liverpool; Andrew Sinclair, Stepping Hill Hospital, Stockport; Rajeshwar Krishnanm, Kent and Canterbury Hospital, Canterbury; Rowland Rees, University Hospital Southampton NHS Foundation Trust, Southampton; James N{\textquoteright}dow, Aberdeen Royal Inrmary, Aberdeen; Bruce Montgomery, Frimley Park Hospital, Camberley; Michael Swinn, East Surrey Hospital, Redhill; Alastair Henderson and John Donohue, Maidstone Hospital, Maidstone; Suzie Venn, St Richard{\textquoteright}s Hospital, Chichester; Robert Mason, Torbay Hospital, Torquay; Sanjeev Madaan, Darent Valley Hospital, Kent; Mustafa Hilmy, York Hospital, York; Vivienne Kirchin, Sunderland Royal Inrmary, Sunderland; Kim Davenport, Cheltenham General Hospital, Cheltenham; John McGrath, Exeter Hospital, Exeter; Tim Porter, Yeovil District Hospital, Yeovil; Ruaraidh MacDonagh and Amerdip Birring, Musgrove Park Hospital, Taunton; Ramachandran Ravi, Basildon University Hospital; Jawad Husain, Royal Albert Edward Inrmary, Wigan; Maj Shabbir, Guy{\textquoteright}s Hospital, London; Omer Baldo, Airedale General Hospital, Keighley; Sadhanshu Chitale, Whittington Hospital, London; Mary Garthwaite, James Cook University Hospital, Middlesbrough; Shalom Srirangam, Royal Blackburn Hospital, Blackburn; Liaqat Chowoo, Bedford Hospital, Bedford; Tina Rashid, Charing Cross Hospital, London; Rob Skyrme; Jon Featherstone, Princess of Wales Hospital, Bridgend; Ammar Alhasso, Edinburgh; and Oleg Tatarov, Cardiff. We thank the following trusts for offering participant identication centre support: Basingstoke and Northamptonshire NHS Foundation Trust; Royal Liverpool and Broadgreen University Hospitals NHS Trust; Chelsea and Westminster NHS Foundation Trust; and Wirral University Teaching Hospital NHS Foundation Trust. We thank the following Trusts for offering PIC support: Basingstoke and Northamptonshire NHS Foundation Trust; Royal Liverpool and Broadgreen University Hospitals NHS Trust; Chelsea and Westminster NHS Foundation Trust; Wirral University Teaching Hospitals NHS Foundation Trust. ",
year = "2021",
month = may,
day = "3",
doi = "10.21203/rs.3.rs-126788/v1",
language = "English",
volume = "21",
journal = "BMC Urology ",
issn = "1471-2490",
publisher = "BMC",
}