Dataset Information

Cost-effectiveness of treatments for superficial venous reflux in patients with chronic venous ulceration.

ABSTRACT: Venous leg ulcers impair quality of life significantly, with substantial costs to health services. The aim of this study was to estimate the cost-effectiveness of interventional procedures alongside compression therapy versus compression therapy alone for the treatment of chronic venous leg ulceration.A Markov decision analytical model was developed. The main outcome measures were quality-adjusted life-years (QALYs) and lifetime costs per patient, from the perspective of the UK National Health Service at 2015 prices. Resource use included the initial procedures, compression therapy, primary care and outpatient consultations. The interventional procedures included superficial venous surgery, endothermal ablation and ultrasound-guided foam sclerotherapy (UGFS). The study population was patients with a chronic venous ulcer who were eligible for either compression therapy or an interventional procedure. Data were obtained from systematic review and meta-analysis of RCTs.Surgery gained 0·112 (95 per cent c.i. -0·011 to 0·213) QALYs compared with compression therapy alone, with a difference in lifetime costs of €-1330 (-3570 to 1262). Given the expected savings in community care, the procedure would pay for itself within 4 years. There was insufficient evidence regarding endothermal ablation and UGFS to draw conclusions.This modelling study found surgery to be more effective and less costly than compression therapy alone. Further RCT evidence is required for both endothermal ablation and UGFS.

SUBMITTER: Epstein D

PROVIDER: S-EPMC6069357 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Cost-effectiveness of treatments for superficial venous reflux in patients with chronic venous ulceration.

Epstein D D Gohel M M Heatley F F Davies A H AH

BJS open 20180510 4

<h4>Background</h4>Venous leg ulcers impair quality of life significantly, with substantial costs to health services. The aim of this study was to estimate the cost-effectiveness of interventional procedures alongside compression therapy versus compression therapy alone for the treatment of chronic venous leg ulceration.<h4>Methods</h4>A Markov decision analytical model was developed. The main outcome measures were quality-adjusted life-years (QALYs) and lifetime costs per patient, from the pers ...[more]

PMID: 30079389

Similar Datasets

Project description:ImportanceOne-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux.ObjectiveTo evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration.Design, setting, and participantsBetween October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019.InterventionsPatients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team.Main outcomes and measuresThe primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness.ResultsThe early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year.Conclusions and relevanceEarly endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence.Trial registrationClinicalTrials.gov identifier: ISRCTN02335796.

Project description:METHODS:An analytical cross-sectional study with 70 individuals divided into two groups. Group A consisted of 35 volunteers who were being preoperatively prepared for the construction of arteriovenous fistula. Group B consisted of 35 non-renal patients selected by convenience. Each participant underwent physical examination, including venous percussion, of the dominant upper limb and then ultrasound. Interobserver agreement was assessed between a trained vascular surgeon performing percussion and fourth-year medical student. Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of percussion were determined in relation to ultrasound. The agreement between the methods, venous percussion and venous duplex ultrasound was also evaluated by the Kappa index. RESULTS:The overall interobserver agreement for the percussion was 0.74 (95% CI 0.632 to 0.851). It was observed that the results were more favorable in the cephalic vein than in the basilic vein, emphasizing that the cephalic is more used in venous punctures, because of its anatomical location and visibility, and in fistula construction. The 35 percussions of the cephalic forearm vein in Group A resulted in a sensitivity of 1.0 (95% CI 0.63 to 1.00), specificity of 0.96 (95% CI 0.81 to 1.00), a positive predictive value of 0.89(95% CI 0.52 to 1.00) and a negative predictive value of 1.00 (95% CI 0.87 to 1.00), with an accuracy of 0.97 (95% CI 0.85 to 1.00) and Kappa index of 0.92 (95% CI 0.77 to 1.00) in relation to ultrasound. Overall, when all venous segments were analyzed in group A, the Kappa index of agreement between the percussion and the ultrasonography reached 0.56 (95% CI 0.401 to 0.72). All venous segments in Group A had a sensitivity of 0.54 (95% CI 0.37 to 0.70) and a specificity of 0.96 (95% CI 0.90 to 0.99). When all venous segments were analyzed in group B, the Kappa index of agreement between the percussion and the ultrasonography reached 0.48 (95% CI 0.34 to 0.62). All venous segments in Group B had a sensitivity of 0.70 (95% CI 0.59 to 0.79) and a specificity of 0.82 (95% CI 0.69 to 0.91). CONCLUSION:Venous percussion of the upper limbs has a high positive predictive value and high specificity, when compared to ultrasound as a way to evaluate the patency and adequacy of the cephalic vein. Although there is not enough evidence to preclude ultrasound, percussion should definitely be included in the traditional physical exam evaluation of upper limbs superficial veins.

Project description:IntroductionVEIN STEP was conducted to collect international data on the management of chronic venous disease (CVD) and to assess the effectiveness of conservative treatments for the relief of CVD signs and symptoms.MethodsThis international, observational, prospective, longitudinal, cohort study recruited adult outpatients consulting for symptomatic CVD. The primary objective was the effectiveness of conservative treatments on symptoms, signs and quality of life in a real-life setting assessed using a range of patient-reported outcome measures: 10-cm Visual Analog and Patient Global Impression of Change scales for symptoms; Venous Clinical Severity Score for physician assessment of signs; and 14-item ChronIc Venous Insufficiency Questionnaire (CIVIQ-14) for quality of life. At inclusion, patients were prescribed conservative treatment according to the physicians' usual practice. Follow-up visits took place at weeks 2 and 4, with an optional week 8 visit.ResultsThe analysis set comprised 6084 subjects (78% female) from nine countries with a mean age of 50.6 ± 13.8 years and BMI of 28.0 ± 4.9 kg/m2. The most common CEAP classifications were C1 (23.0%), C2 (31.6%), and C3 (30.7%). Conservative therapy consisted of oral venoactive drugs (VADs; 95.8% of subjects) including micronized purified flavonoid fraction (MPFF 75.5%) and diosmin (18.8%), compression (52.0%), and topicals (31.5%). Conservative therapy led to global symptom improvement in 89% of patients after 2 weeks and 96% at 4 weeks. Pain, leg heaviness, cramps, and sensation of swelling were improved in 82%, 71%, 45.5%, and 46% of patients, respectively. Conservative therapy was associated with a decrease over time in patient-assessed global symptom intensity: - 2.37 ± 1.73 (P < 0.001) and physician-assessed disease severity - 1.83 ± 2.82 (P < 0.001). Among the VADs, MPFF-based conservative therapy was associated with the greatest reduction in symptom and sign intensity. Improvements in CIVIQ-14 were observed with all treatments but were greatest for MPFF.ConclusionIn this prospective study conducted in the real-world setting, treatment with conservative therapy, in particular MPFF, was associated with meaningful improvements in the clinical signs and symptoms of disease as well as in quality of life in patients with CVD.Trial registrationClinicalTrials.gov identifier NCT04574375.

Dataset Information

Cost-effectiveness of treatments for superficial venous reflux in patients with chronic venous ulceration.

Publications

Cost-effectiveness of treatments for superficial venous reflux in patients with chronic venous ulceration.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets