title: Evaluation of the cost effectiveness of vesico-amniotic shunting in the management of congenital lower urinary tract obstruction (based on data from the PLUTO Trial).
abstract: OBJECTIVE
  To determine the cost-effectiveness of in-utero percutaneous Vesico Amniotic Shunt (VAS) in the management of fetal lower urinary tract obstruction (LUTO).
  
  
  METHODS
  Model based economic analysis using data from the randomised controlled arm of the PLUTO (percutaneous vesico-amniotic shunting for lower urinary tract obstruction) trial.
  
  
  METHODS
  Fetal medicine departments in United Kingdom, Ireland and Netherlands.
  
  
  METHODS
  Pregnant women with a male, singleton fetus with LUTO.
  
  
  METHODS
  Costs and outcomes were prospectively collected in the trial; three separate base case analyses were performed using the intention to treat (ITT), per protocol and uniform prior methods. Deterministic and probabilistic sensitivity analyses were performed to explore data uncertainty.
  
  
  METHODS
  Survival at 28 days, 1 year and disease free survival at 1 year.
  
  
  RESULTS
  VAS was more expensive but appeared to result in higher rates of survival compared with conservative management in patients with LUTO. Using ITT analysis the incremental cost effectiveness ratios based on outcomes of survival at 28 days, 1 year, or 1 morbidity-free year on the VAS arm were £ 15,506, £ 15,545, and £ 43,932, respectively.
  
  
  CONCLUSIONS
  VAS is a more expensive option compared to the conservative approach in the management of individuals with LUTO. Data from the RCT suggest that VAS improves neonatal survival but does not result in significant improvements in morbidity. Our analysis concludes that VAS is not likely to be cost effective in the management of these patients given the NICE (National Institute of Health and Clinical Excellence) cost threshold of £ 20,000 per QALY.
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, The Public Health Building, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Lavanya
authors.initials: L
authors.lastname: Diwakar
authors.affiliation: School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom ; Fetal Medicine Centre, Birmingham Women's Hospital NHS Foundation Trust, Edgbaston, Birmingham, United Kingdom.
authors.forename: Rachel K
authors.initials: RK
authors.lastname: Morris
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, The Public Health Building, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Pelham
authors.initials: P
authors.lastname: Barton
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Lee J
authors.initials: LJ
authors.lastname: Middleton
authors.affiliation: School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom ; Fetal Medicine Centre, Birmingham Women's Hospital NHS Foundation Trust, Edgbaston, Birmingham, United Kingdom.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Kilby
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, The Public Health Building, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Tracy E
authors.initials: TE
authors.lastname: Roberts
mesh_terms: D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D003663:Decision Trees; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D016013:Likelihood Functions; D008297:Male; D009010:Monte Carlo Method; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic; D015607:Stents / Q000191:economics*; D001748:Urinary Bladder Neck Obstruction / Q000191:economics* / Q000601:surgery*