Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial

Julie Brittenden; Seonaidh C. Cotton; Andrew Elders; Emma Tassie; Graham Scotland; Craig R. Ramsay; John Norrie; Jennifer Burr; Jill Francis; Samantha Wileman; Bruce Campbell; Paul Bachoo; Ian Chetter; Michael Gough; Jonothan Earnshaw; Tim Lees; Julian Scott; Sara A. Baker; Graeme MacLennan; Maria Prior; Denise Bolsover; Marion K. Campbell

doi:10.3310/hta19270

Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial

Julie Brittenden^*, Seonaidh C. Cotton, Andrew Elders, Emma Tassie, Graham Scotland, Craig R. Ramsay, John Norrie, Jennifer Burr, Jill Francis, Samantha Wileman, Bruce Campbell, Paul Bachoo, Ian Chetter, Michael Gough, Jonothan Earnshaw, Tim Lees, Julian Scott, Sara A. Baker, Graeme MacLennan, Maria PriorDenise Bolsover, Marion K. Campbell

^*Corresponding author for this work

NMAHP

Research output: Contribution to journal › Article › peer-review

76 Citations (Scopus)

Abstract

Primary outcome measures: Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Secondary outcome measures: Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. Results: The results appear generalisable in that participants’ baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈5%). With regard to secondary outcomes, health gains at 6 weeks (p

Original language	English
Pages (from-to)	1-380
Number of pages	380
Journal	Health Technology Assessment
Volume	19
Issue number	27
DOIs	https://doi.org/10.3310/hta19270
Publication status	Published - 30 Apr 2015

Keywords

activities of daily living
adolescent
biomedical
aged
aged, 80 and over
cost-benefit analysis
health Care/economics
health expenditures/statistics & numerical data
varicose veins/economics
laser therapy/adverse effects
young adult
middle aged
outcome and process assessment
quality-adjusted life years
recurrence
sclerotherapy/adverse effects
severity of Illness Index
state medicine/economics
technology assessment
United Kingdom

ASJC Scopus subject areas

Health Policy

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Brittenden, J., Cotton, S. C., Elders, A., Tassie, E., Scotland, G., Ramsay, C. R., Norrie, J., Burr, J., Francis, J., Wileman, S., Campbell, B., Bachoo, P., Chetter, I., Gough, M., Earnshaw, J., Lees, T., Scott, J., Baker, S. A., MacLennan, G., ... Campbell, M. K. (2015). Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technology Assessment, 19(27), 1-380. https://doi.org/10.3310/hta19270

@article{855d0ece0c714e90886f341a6b151d58,

title = "Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial",

abstract = "Primary outcome measures: Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Secondary outcome measures: Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. Results: The results appear generalisable in that participants{\textquoteright} baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈5%). With regard to secondary outcomes, health gains at 6 weeks (p ",

keywords = "activities of daily living, adolescent, biomedical, aged, aged, 80 and over, cost-benefit analysis, health Care/economics, health expenditures/statistics & numerical data, varicose veins/economics, laser therapy/adverse effects, young adult, middle aged, outcome and process assessment, quality-adjusted life years, recurrence, sclerotherapy/adverse effects, severity of Illness Index, state medicine/economics, technology assessment, United Kingdom",

author = "Julie Brittenden and Cotton, {Seonaidh C.} and Andrew Elders and Emma Tassie and Graham Scotland and Ramsay, {Craig R.} and John Norrie and Jennifer Burr and Jill Francis and Samantha Wileman and Bruce Campbell and Paul Bachoo and Ian Chetter and Michael Gough and Jonothan Earnshaw and Tim Lees and Julian Scott and Baker, {Sara A.} and Graeme MacLennan and Maria Prior and Denise Bolsover and Campbell, {Marion K.}",

note = "Only MM/YYYY available for pub date, used last date in month - CR (06/09/20) Mis-match between title on webpage and title in PDF - changed to match PDF title - CR (07/09/20)",

year = "2015",

month = apr,

day = "30",

doi = "10.3310/hta19270",

language = "English",

volume = "19",

pages = "1--380",

journal = "Health Technology Assessment",

issn = "1366-5278",

publisher = "NIHR Journals Library",

number = "27",

}

Brittenden, J, Cotton, SC, Elders, A, Tassie, E, Scotland, G, Ramsay, CR, Norrie, J, Burr, J, Francis, J, Wileman, S, Campbell, B, Bachoo, P, Chetter, I, Gough, M, Earnshaw, J, Lees, T, Scott, J, Baker, SA, MacLennan, G, Prior, M, Bolsover, D & Campbell, MK 2015, 'Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial', Health Technology Assessment, vol. 19, no. 27, pp. 1-380. https://doi.org/10.3310/hta19270

Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. / Brittenden, Julie; Cotton, Seonaidh C.; Elders, Andrew et al.
In: Health Technology Assessment, Vol. 19, No. 27, 30.04.2015, p. 1-380.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial

AU - Brittenden, Julie

AU - Cotton, Seonaidh C.

AU - Elders, Andrew

AU - Tassie, Emma

AU - Scotland, Graham

AU - Ramsay, Craig R.

AU - Norrie, John

AU - Burr, Jennifer

AU - Francis, Jill

AU - Wileman, Samantha

AU - Campbell, Bruce

AU - Bachoo, Paul

AU - Chetter, Ian

AU - Gough, Michael

AU - Earnshaw, Jonothan

AU - Lees, Tim

AU - Scott, Julian

AU - Baker, Sara A.

AU - MacLennan, Graeme

AU - Prior, Maria

AU - Bolsover, Denise

AU - Campbell, Marion K.

N1 - Only MM/YYYY available for pub date, used last date in month - CR (06/09/20) Mis-match between title on webpage and title in PDF - changed to match PDF title - CR (07/09/20)

PY - 2015/4/30

Y1 - 2015/4/30

N2 - Primary outcome measures: Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Secondary outcome measures: Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. Results: The results appear generalisable in that participants’ baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈5%). With regard to secondary outcomes, health gains at 6 weeks (p

AB - Primary outcome measures: Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Secondary outcome measures: Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. Results: The results appear generalisable in that participants’ baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈5%). With regard to secondary outcomes, health gains at 6 weeks (p

KW - activities of daily living

KW - adolescent

KW - biomedical

KW - aged

KW - aged, 80 and over

KW - cost-benefit analysis

KW - health Care/economics

KW - health expenditures/statistics & numerical data

KW - varicose veins/economics

KW - laser therapy/adverse effects

KW - young adult

KW - middle aged

KW - outcome and process assessment

KW - quality-adjusted life years

KW - recurrence

KW - sclerotherapy/adverse effects

KW - severity of Illness Index

KW - state medicine/economics

KW - technology assessment

KW - United Kingdom

U2 - 10.3310/hta19270

DO - 10.3310/hta19270

M3 - Article

C2 - 25858333

SN - 1366-5278

VL - 19

SP - 1

EP - 380

JO - Health Technology Assessment

JF - Health Technology Assessment

IS - 27

ER -

Brittenden J, Cotton SC, Elders A, Tassie E, Scotland G, Ramsay CR et al. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technology Assessment. 2015 Apr 30;19(27):1-380. doi: 10.3310/hta19270