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)

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@article{92dc186586f74d909b92d9e9e7f8942b,
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).DESIGN: Model based economic analysis using data from the randomised controlled arm of the PLUTO (percutaneous vesico-amniotic shunting for lower urinary tract obstruction) trial.SETTING: Fetal medicine departments in United Kingdom, Ireland and Netherlands.POPULATION OR SAMPLE: 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.MAIN OUTCOME MEASURES: 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.",
keywords = "Computer Simulation, Cost-Benefit Analysis, Decision Trees, Evaluation Studies as Topic, Female, Humans, Intention to Treat Analysis, Likelihood Functions, Male, Monte Carlo Method, Pregnancy, Randomized Controlled Trials as Topic, Stents, Urinary Bladder Neck Obstruction",
author = "Lavanya Diwakar and Morris, {Rachel K} and Pelham Barton and Middleton, {Lee J} and Kilby, {Mark D} and Roberts, {Tracy E}",
year = "2013",
month = dec,
day = "20",
doi = "10.1371/journal.pone.0082564",
language = "English",
volume = "8",
journal = "PLoSONE",
issn = "1932-6203",
publisher = "Public Library of Science (PLOS)",
number = "12",

}

RIS

TY - JOUR

T1 - 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)

AU - Diwakar, Lavanya

AU - Morris, Rachel K

AU - Barton, Pelham

AU - Middleton, Lee J

AU - Kilby, Mark D

AU - Roberts, Tracy E

PY - 2013/12/20

Y1 - 2013/12/20

N2 - OBJECTIVE: To determine the cost-effectiveness of in-utero percutaneous Vesico Amniotic Shunt (VAS) in the management of fetal lower urinary tract obstruction (LUTO).DESIGN: Model based economic analysis using data from the randomised controlled arm of the PLUTO (percutaneous vesico-amniotic shunting for lower urinary tract obstruction) trial.SETTING: Fetal medicine departments in United Kingdom, Ireland and Netherlands.POPULATION OR SAMPLE: 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.MAIN OUTCOME MEASURES: 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.

AB - OBJECTIVE: To determine the cost-effectiveness of in-utero percutaneous Vesico Amniotic Shunt (VAS) in the management of fetal lower urinary tract obstruction (LUTO).DESIGN: Model based economic analysis using data from the randomised controlled arm of the PLUTO (percutaneous vesico-amniotic shunting for lower urinary tract obstruction) trial.SETTING: Fetal medicine departments in United Kingdom, Ireland and Netherlands.POPULATION OR SAMPLE: 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.MAIN OUTCOME MEASURES: 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.

KW - Computer Simulation

KW - Cost-Benefit Analysis

KW - Decision Trees

KW - Evaluation Studies as Topic

KW - Female

KW - Humans

KW - Intention to Treat Analysis

KW - Likelihood Functions

KW - Male

KW - Monte Carlo Method

KW - Pregnancy

KW - Randomized Controlled Trials as Topic

KW - Stents

KW - Urinary Bladder Neck Obstruction

U2 - 10.1371/journal.pone.0082564

DO - 10.1371/journal.pone.0082564

M3 - Article

C2 - 24376546

VL - 8

JO - PLoSONE

JF - PLoSONE

SN - 1932-6203

IS - 12

M1 - e82564

ER -