Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration

Gohel, Manjit; Mora, Jocelyn; Szigeti, Mátyás; Epstein, David; Heatley, Francine; Bradbury, Andrew W.; Bulbulia, Richard; Cullum, Nicky; Nyamekye, Isaac; Poskitt, K. R.; Renton, Sophie; Warwick, Jane; Davies, Alun H.

doi:10.1001/jamasurg.2020.3845

Cited by 40 publications

(32 citation statements)

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“…The purpose of this study is to compare methods for handling missing data in cost-effectiveness analysis, using as a case-study a 5-year clinical trial: The Early Endovenous Ablation in Venous Ulceration (EVRA) (7). With a given dataset, there are several ways in which the chosen missing data approach might influence the results: different subjects used in the analysis, different number of observations used per subject, different statistical models of the missing data mechanism and the latent correlation between observed and missing observations, or different estimation model to estimate total mean costs and QALYs and the correlation between them.…”

Section: Comparing Methods For Handling Missing Cost and Outcome Data In Clinical Trial-based Cost-effectiveness Analysis 1 Introductionmentioning

confidence: 99%

“…The Early Endovenous Ablation in Venous Ulceration (EVRA) randomised clinical trial evaluated the cost-effectiveness of "early" versus "deferred" endovenous ablation to treat venous leg ulcers. The trial methods and patients are described elsewhere (7). Briefly, resource use items in hospital, primary and community care and medications related to the treatment of venous ulceration, adverse events or complications were collected by case note review and questionnaires completed at baseline and monthly thereafter up to one year, plus one further telephone follow up between October 2018 and March 2019.…”

Section: Datamentioning

confidence: 99%

“…Each item of resource use was multiplied by UK unit costs obtained from published literature, NHS reference costs, and manufacturers' list prices to calculate overall costs within each of these categories for each patient (7). The costs for each individual over their follow-up (from randomization to date of censoring for that individual) were assigned or apportioned into discrete time periods, that corresponded to 12 monthly periods during the first year (as follow-ups were monthly) and then yearly periods thereafter.…”

Section: Datamentioning

confidence: 99%

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Comparing Methods for Handling Missing Cost and Outcome Data in Clinical Trial-based Cost-effectiveness Analysis

Diop

Epstein

2021

Preprint

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OBJECTIVES: This study compares methods for handling missing data to conduct cost-effectiveness analysis in the context of a clinical study.METHODS: A long-term clinical trial with staggered recruitment was used as a case study (EVRA, NIHR-HTA project 11/129/197). Patients had between 1 year and 5.5 years (median 3 years) of follow-up under “early” or “deferred” treatment. The methods compared were Complete-Case-Analysis (CCA), multiple imputation using linear regression (MILR) and using predictive mean matching (MIPMM), Bayesian parametric approach using the R package missingHE (BPA) and repeated measures mixed model (RMM). The outcomes were total mean costs and total mean quality-adjusted life years (QALYs) at different time horizons (1 year, 3 years and 5 years). RESULTS: All methods found no statistically significant difference in cost at the 5% level in all years, and all methods found statistically significantly greater mean QALY at year 1. At year 3, BPA showed a statistically significant difference while other method did not at later time horizons. Standard errors differed substantially between the methods employed. CONCLUSION: MIPMM seemed to perform better than MILM, confirming findings from simulation studies. RMM and BPA might be feasible options, though they did not perform better than MIPMM in this dataset. Further simulation studies and applications should continue to compare these methods.

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Section: Comparing Methods For Handling Missing Cost and Outcome Data In Clinical Trial-based Cost-effectiveness Analysis 1 Introductionmentioning

confidence: 99%

Section: Datamentioning

confidence: 99%

Section: Datamentioning

confidence: 99%

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Comparing Methods for Handling Missing Cost and Outcome Data in Clinical Trial-based Cost-effectiveness Analysis

Diop

Epstein

2021

Preprint

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“…This study compares the results of a cost-effectiveness analysis of strategies for treating venous leg ulcers, using different methods for handling missing data. The strategies compared were early endovenous ablation of the ulcer versus delayed ablation (4). This work is unable to demonstrate which approach is "correct", because we do not know the values of the missing data.…”

Section: Introductionmentioning

confidence: 96%

“…Nevertheless, this trial provides an interesting case study because, due to the design of the trial, there was very low loss to follow-up, but considerable item missingness (see Methods: Data). The original cost-effectiveness analysis employed a repeated measure mixed model (RMM), and reported mean total cost of -£155 (95% CI, -£1262 to £953) and mean total QALY of 0.073 (95% CI, -0.06 to 0.20) at 3 years (4). RMM has been shown to have acceptable properties in simulation studies (5).…”

Section: Introductionmentioning

confidence: 99%

Comparing Methods for Handling Missing Cost and Outcome Data in Clinical Trial-based Cost-effectiveness Analysis

Diop

Epstein

2021

Preprint

View full text Add to dashboard Cite

OBJECTIVES: This study compares methods for handling missing data to conduct cost-effectiveness analysis in the context of a clinical study.METHODS: Patients in the Early Endovenous Ablation in Venous Ulceration (EVRA) trial had between 1 year and 5.5 years (median 3 years) of follow-up under early or deferred endovenous ablation. This study compares Complete-Case-Analysis (CCA), multiple imputation using linear regression (MILR) and using predictive mean matching (MIPMM), Bayesian parametric approach using the R package missingHE (BPA) and repeated measures mixed model (RMM). The outcomes were total mean costs and total mean quality-adjusted life years (QALYs) at different time horizons (1 year, 3 years and 5 years). RESULTS: All methods found no statistically significant difference in cost at the 5% level in all time horizons, and all methods found statistically significantly greater mean QALY at year 1. By year 3, only BPA showed a statistically significant difference in QALY. Standard errors differed substantially between the methods employed. CONCLUSION: CCA can be biased if data are MAR, and is wasteful of the data. Hence the results for CCA are likely to be inaccurate. Other methods coincide in suggesting that early intervention is cost-effective at a threshold of £20,000 per QALY over all time horizons. However, the variation in the results across the methods does generate some additional methodological uncertainty, underlining the importance of conducting sensitivity analyses using alternative approaches.

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Cost-effectiveness of Compression Therapy With Early Endovenous Ablation in Venous Ulceration for a Medicare Population

et al. 2022

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ImportanceVenous leg ulcers (VLU) are the most common cause of lower extremity ulceration that commonly occur among older individuals and are characterized by a slow healing trajectory and frequent recurrence; in the United States, VLUs affect more than 600 000 people per year with an estimated cost of $3.5 billion. Clinical trial data show that early intervention with endovenous ablation substantially improves the healing rate and reduces recurrence among patients with VLUs, but there is a need to assess the cost-effectiveness of early endovenous ablation in the US context.ObjectivesTo evaluate the cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with VLU from the US Medicare perspective.Design, Setting, and ParticipantsThis economic evaluation used a Markov model to simulate the disease progression of VLU for patients receiving compression therapy with early vs deferred ablation over 3 years. The simulated cohort included patients with VLU aged 65 years and older who had clinical characteristics similar to those in the randomized Early Venous Reflux Ablation trial in the United Kingdom. Data were analyzed from September 2021 to June 2022.Main Outcomes and MeasuresDirect medical costs, quality-adjusted life years (QALYs), and the incremental monetary benefits at a willingness-to-pay threshold of $100 000/QALY. Univariate and probabilistic sensitivity analyses were performed to test uncertainty of model results.ResultsThis model used a simulated cohort of patients with VLU aged 65 years and older enrolled in Medicare. Early ablation dominated, with a lower per-patient cost of $12 527 and an increase of 2.011 QALYs, whereas compression therapy with deferred ablation yielded a per-patient cost of $15 208 and 1.985 QALYs gained. At a $100 000/QALY cost-effectiveness threshold, the incremental net monetary benefit was $5226 per patient in favor of early ablation. Probability of healing, followed by the probability of recurrence, was the parameter with greatest impact on model uncertainty. The probabilistic sensitivity analysis showed that early ablation was cost-effective in 59.2% of simulations at the $100 000/QALY threshold.Conclusions and RelevanceIn this economic evaluation of compression therapy with early endovenous ablation, early intervention was dominant, as it was cost saving and generated greater QALYs over 3 years from the US Medicare perspective. Payers should prioritize coverage for early ablation to prevent VLU complications rather than treat a costly outcome that also reduces patient well-being.

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Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration

Cited by 40 publications

References 21 publications

Comparing Methods for Handling Missing Cost and Outcome Data in Clinical Trial-based Cost-effectiveness Analysis

Comparing Methods for Handling Missing Cost and Outcome Data in Clinical Trial-based Cost-effectiveness Analysis

Comparing Methods for Handling Missing Cost and Outcome Data in Clinical Trial-based Cost-effectiveness Analysis

Cost-effectiveness of Compression Therapy With Early Endovenous Ablation in Venous Ulceration for a Medicare Population

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