Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

D M Epstein¹, M S Gohel^{2

3}, F Heatley³, X Liu⁴, A Bradbury⁵, R Bulbulia^{6

7

8}, N Cullum⁹, I Nyamekye¹⁰, K R Poskitt⁶, S Renton¹¹, J Warwick^{3

12}, A H Davies³; EVRA trial investigators

Collaborators, Affiliations

Collaborators

EVRA trial investigators:
M S Gohel, D Read, S Hargreaves, K Dhillon, M Anwar, A Liddle, H Brown, K Mercer, F Gill, A Liu, W Jepson, A Wormwell, H Rafferty, A H Davies, K Dhillon, R Kaur, E Solomon, K Sritharan, R Velineni, C S Lim, A Busuttil, R Bootun, C Bicknell, M Jenkins, T Lane, E Serjeant, K Poskitt, R Bulbulia, J Waldron, G Wolfrey, F Slim, C Davies, L Emerson, M Grasty, M Whyman, C Wakeley, A Cooper, J Clapp, N Hogg, J Howard, J Dyer, S Lyes, D Teemul, K Harvey, M Pride, A Kindon, H Price, L Flemming, G Birch, H Holmes, J Weston, T Joseph, R Eiffel, T Ojimba, T Wilson, A Hodgson, L Robinson, J Todhunter, D Heagarty, A Mckeane, R McCarthy, J Barwell, C Northcott, A Elstone, C West, P Chong, D Gerrard, A Croucher, S Levy, C Martin, T Craig, D Carradice, A Firth, E Clarke, A Oswald, J Sinclair, I Chetter, J El-Sheikha, S Nandhra, C Leung, J Scott, N Dewhirst, J Woods, D Russell, R Darwood, M Troxler, J Thackeray, D Bell, D Watson, L Williamson, J Coulston, P Eyers, K Darvall, I Hunter, A Stewart, A Moss, J Rewbury, C Adams, L Vickery, L Foote, H Durman, F Venn, P Hill, K James, F Luxton, D Greenwell, K Roberts, S Mitchell, M Tate, H Mills, A Garnham, S Hobbs, D McIntosh, M Green, K Collins, J Rankin, P Poulton, V Isgar, S Renton, K Dhillon, M Trivedi, M Kafeza, S Parsapour, H Moore, M Najem, S Connarty, H Albon, C Lloyd, J Trant, R Vohra, J McCormack, J Marshall, V Hardy, R Rogoveanu, W Goff, A Garnham, R Gidda, S Merotra, S Shiralkar, A Jayatunga, R Pathak, A Rehman, K Randhawa, J Lewis, S Fullwood, S Jennings, S Cole, M Wall, C Ranaboldo, S Hulin, C Clarke, R Fennelly, R Cooper, R Boyes, C Draper, L Harris, D Mead, A Bradbury, L Kelly, G Bate, H Davies, M Popplewell, M Claridge, M Gannon, H Khaira, M Scriven, T Wilmink, D Adam, H Nasr, D Dodd, S Nawaz, J Humphreys, M Barnes, J Sorrell, D Swift, P Phillips, H Trender, N Fenwick, D Rittoo, S Baker, R Mitchell, S Andrews, S Williams, J Stephenson, I Nyamekye, S Holloway, W Hayes, J Day, C Clayton, D Harding, A Thompson, A Gibson, Z Murphy, T Smith

Affiliations

¹ Department of Applied Economics, University of Granada, Granada, Spain.
² Department of Vascular Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
³ Department of Surgery and Cancer, Imperial College London, London, UK.
⁴ Imperial Clinical Trials Unit, Imperial College London, London, UK.
⁵ Department of Vascular Surgery, Institute of Cardiovascular Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
⁶ Cheltenham Vascular Unit, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.
⁷ Medical Research Council Population Health Research Unit, University of Oxford, Oxford, UK.
⁸ Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁹ School of Health Sciences, University of Manchester, Manchester, UK.
¹⁰ Department of Vascular Surgery, Worcestershire Acute Hospitals NHS Trust, Worcester, UK.
¹¹ Northwick Park Hospital, North West London Hospitals NHS Trust, London, UK.
¹² Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Warwick, UK.

PMID: 30741425
DOI: 10.1002/bjs.11082

Randomized Controlled Trial

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

D M Epstein et al. Br J Surg. 2019 Apr.

. 2019 Apr;106(5):555-562.

doi: 10.1002/bjs.11082. Epub 2019 Feb 11.

Authors

Collaborators

EVRA trial investigators:
M S Gohel, D Read, S Hargreaves, K Dhillon, M Anwar, A Liddle, H Brown, K Mercer, F Gill, A Liu, W Jepson, A Wormwell, H Rafferty, A H Davies, K Dhillon, R Kaur, E Solomon, K Sritharan, R Velineni, C S Lim, A Busuttil, R Bootun, C Bicknell, M Jenkins, T Lane, E Serjeant, K Poskitt, R Bulbulia, J Waldron, G Wolfrey, F Slim, C Davies, L Emerson, M Grasty, M Whyman, C Wakeley, A Cooper, J Clapp, N Hogg, J Howard, J Dyer, S Lyes, D Teemul, K Harvey, M Pride, A Kindon, H Price, L Flemming, G Birch, H Holmes, J Weston, T Joseph, R Eiffel, T Ojimba, T Wilson, A Hodgson, L Robinson, J Todhunter, D Heagarty, A Mckeane, R McCarthy, J Barwell, C Northcott, A Elstone, C West, P Chong, D Gerrard, A Croucher, S Levy, C Martin, T Craig, D Carradice, A Firth, E Clarke, A Oswald, J Sinclair, I Chetter, J El-Sheikha, S Nandhra, C Leung, J Scott, N Dewhirst, J Woods, D Russell, R Darwood, M Troxler, J Thackeray, D Bell, D Watson, L Williamson, J Coulston, P Eyers, K Darvall, I Hunter, A Stewart, A Moss, J Rewbury, C Adams, L Vickery, L Foote, H Durman, F Venn, P Hill, K James, F Luxton, D Greenwell, K Roberts, S Mitchell, M Tate, H Mills, A Garnham, S Hobbs, D McIntosh, M Green, K Collins, J Rankin, P Poulton, V Isgar, S Renton, K Dhillon, M Trivedi, M Kafeza, S Parsapour, H Moore, M Najem, S Connarty, H Albon, C Lloyd, J Trant, R Vohra, J McCormack, J Marshall, V Hardy, R Rogoveanu, W Goff, A Garnham, R Gidda, S Merotra, S Shiralkar, A Jayatunga, R Pathak, A Rehman, K Randhawa, J Lewis, S Fullwood, S Jennings, S Cole, M Wall, C Ranaboldo, S Hulin, C Clarke, R Fennelly, R Cooper, R Boyes, C Draper, L Harris, D Mead, A Bradbury, L Kelly, G Bate, H Davies, M Popplewell, M Claridge, M Gannon, H Khaira, M Scriven, T Wilmink, D Adam, H Nasr, D Dodd, S Nawaz, J Humphreys, M Barnes, J Sorrell, D Swift, P Phillips, H Trender, N Fenwick, D Rittoo, S Baker, R Mitchell, S Andrews, S Williams, J Stephenson, I Nyamekye, S Holloway, W Hayes, J Day, C Clayton, D Harding, A Thompson, A Gibson, Z Murphy, T Smith

Affiliations

¹ Department of Applied Economics, University of Granada, Granada, Spain.
² Department of Vascular Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
³ Department of Surgery and Cancer, Imperial College London, London, UK.
⁴ Imperial Clinical Trials Unit, Imperial College London, London, UK.
⁵ Department of Vascular Surgery, Institute of Cardiovascular Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
⁶ Cheltenham Vascular Unit, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.
⁷ Medical Research Council Population Health Research Unit, University of Oxford, Oxford, UK.
⁸ Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁹ School of Health Sciences, University of Manchester, Manchester, UK.
¹⁰ Department of Vascular Surgery, Worcestershire Acute Hospitals NHS Trust, Worcester, UK.
¹¹ Northwick Park Hospital, North West London Hospitals NHS Trust, London, UK.
¹² Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Warwick, UK.

PMID: 30741425
DOI: 10.1002/bjs.11082

Abstract

Background: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers.

Methods: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol.

Results: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective.

Conclusion: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com).

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Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Collaborators

Affiliations

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration

Authors

Collaborators

Affiliations

Abstract

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources