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      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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          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.

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          Most cited references 10

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          • Abstract: found
          • Article: not found

          Modelling in the economic evaluation of health care: selecting the appropriate approach.

          To provide an overview of alternative approaches to modelling in economic evaluation, and to highlight situations where each of the alternative modelling techniques should be employed. A review of the available approaches to modelling in the economic evaluation of health care interventions with a leading discussion of examples of published studies leading to guidance in the selection of an appropriate approach in different circumstances. The main approaches to modelling used in economic evaluations in health care are decision trees, Markov models and individual sampling models. These methods assume independence of individuals within the model. Where interaction between individuals is important, other methods such as discrete-event simulation or system dynamics are preferable. The paper highlights the crucial question to be answered when selecting the approach to modelling: can the individuals being simulated in the model be regarded as independent? This issue is very commonly not recognised by analysts but is fundamental to the appropriate application of modelling in economic evaluation.
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            Long-term outcomes in children treated by prenatal vesicoamniotic shunting for lower urinary tract obstruction.

            Limited information is available about long-term outcomes in children treated prenatally for lower urinary tract obstruction. Our aim was to evaluate outcomes in children treated in utero with vesicoamniotic shunts. Clinical outcomes in 20 pregnancies with a singleton male fetus, oligo/anhydramnios, and lower urinary tract obstruction were studied using chart review and phone and written clinical questionnaire for parents, pediatricians, and urologists. Overall 1-year survival was 91%. Two neonatal deaths occurred from pulmonary hypoplasia. Mean gestational age at delivery was 34.6 weeks, mean days from shunting to delivery were 84.4, and mean birth weight was 2,574 g. Prenatal urinary prognosis was good in 13, borderline in 2, and poor in 3 of the survivors. Mean age at follow-up was 5.83 years. Posterior urethral valves were confirmed in 7 males, urethral atresia in 4, and prune belly syndrome in 7. Eight children had acceptable renal function, 4 had mild insufficiency, and 6 required dialysis and eventual renal transplant. Eleven children had normal bladder function with spontaneous voiding, 6 required catheterization, and 1 child still had a vesicostomy. Height and weight were below the 25th percentile in 9 children. Persistent respiratory problems were present in 8, musculoskeletal problems in 9, and frequent urinary tract infections were reported in 9. Health-related quality of life results in our group with lower urinary tract obstruction were similar to those in a healthy child population. Male children who underwent prenatal bladder shunting were neurodevelopmentally normal. Although one third of the surviving babies required dialysis and transplantation, the majority have acceptable renal and bladder function and report satisfactory quality of life. III.
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              Antenatal ultrasound to predict postnatal renal function in congenital lower urinary tract obstruction: systematic review of test accuracy.

              Congenital urinary tract obstruction can lead to perinatal mortality and morbidity. Assessing antenatal ultrasound features may help identify fetuses likely to suffer complications. To evaluate the accuracy of antenatal ultrasound in the prediction of postnatal renal function in cases of congenital lower urinary tract obstruction (LUTO). We conducted electronic searches in MEDLINE, EMBASE, the Cochrane Library, MEDION, SIGLE, SCISEARCH Index of scientific and technical proceedings, National Research Register (database inception - 2008) and Medical Conferences register and searched reference lists. Two reviewers independently selected articles in which the accuracy of fetal ultrasound features were evaluated to predict postnatal renal function with no language restrictions. Data were extracted on study characteristics, quality and results to construct 2 x 2 tables. Likelihood ratios for positive (LR+) and negative (LR-) test results, sensitivity and specificity were generated for the different ultrasound parameters and reference standards. Thirteen articles that met the selection criteria, including 215 women and 33 2 x 2 tables. Meta-analysis was performed using clinically similar subgroups to minimise clinical heterogeneity. The ultrasound parameter that showed the best predictive value for postnatal renal function in survivors was renal cortical appearance, sensitivity 0.57 (95% CI 0.37-0.76) and specificity 0.84 (95% CI 0.71-0.94), area under the curve 0.78. Measurement of amniotic fluid volume and the appearance of the renal cortex at diagnosis of LUTO show promising predictive accuracy for poor postnatal renal function.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                20 December 2013
                : 8
                : 12
                Affiliations
                [1 ]Health Economics Unit, School of Health and Population Sciences, The Public Health Building, University of Birmingham, Birmingham, United Kingdom
                [2 ]School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
                [3 ]Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom
                [4 ]Fetal Medicine Centre, Birmingham Women's Hospital NHS Foundation Trust, Edgbaston, Birmingham, United Kingdom
                University of Alabama at Birmingham, United States of America
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: TER PB RKM MDK. Performed the experiments: LD PB TER. Analyzed the data: LD PB LM TER. Contributed reagents/materials/analysis tools: LD TER PB RKM MDK. Wrote the paper: LD PB TER.

                Article
                PONE-D-13-29626
                10.1371/journal.pone.0082564
                3869698
                24376546

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Counts
                Pages: 10
                Funding
                ISRCTN53328556. Funded by the NIHR HTA programme between September 2008 and September 2012 and by Wellbeing of Women (UK) between 2005 to 2008. HTA funding URL: http://www.hta.ac.uk/project/1732.asp. URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN53328556. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article

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