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

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)1-341
Number of pages341
JournalHealth Technology Assessment
Volume19
Issue number27
DOIs
Publication statusPublished - 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

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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), 1-341. https://doi.org/10.3310/hta19270