Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial).

OBJECTIVES: To establish the cost-effectiveness of surgery and sclerotherapy for the treatment of varicose veins. DESIGN: Randomised controlled trials (RCTs) were carried out for conservative treatment, sclerotherapy and surgery for varicose veins. An economic analysis was carried out alongside the randomised trial. Economic modelling was undertaken based on the primary data collection and a literature review (database searches undertaken in April 2000 and updated in March 2001). SETTING: Primary data collection was from a large district general hospital and a teaching hospital both in England over a 2-year period from January 1999. Cost-effectiveness analysis and economic modelling were carried out using an NHS perspective. PARTICIPANTS: A total of 1009 patients were recruited. INTERVENTIONS: Thirty-four patents were randomised in Group 1 (minor varicose veins with no reflux, randomised between conservative treatment and sclerotherapy), 77 in Group 2 (moderate varicose veins with reflux, randomised between surgery and sclerotherapy) and 246 in Group 3 (severe varicose veins with reflux, randomised between conservative treatment and surgery). The remaining 652 patients formed the observational part of the study. MAIN OUTCOME MEASURES: The cost-effectiveness analysis was based on NHS treatment costs for the 2002--3 financial year, and utilities based on the Short Form 6D (SF-6D) preference-based health measure. For the clinical trial, the outcome measures were health-related quality of life (HRQoL) [Short Form with 36 Items (SF-36), EuroQol quality of life questionnaire (EQ-5D), visual analogue scale (VAS) and standard gamble], symptomatic relief, anatomical extent (for which a new classification was developed and validated), patient satisfaction and the incidence of complications. RESULTS: Of the RCTs, only the Group 3 trial was large enough to provide clear results. This showed that surgical treatment produced better results than conservative treatment in terms of HRQoL, symptomatic relief, anatomical extent and patient satisfaction. Clinical outcomes of surgery and sclerotherapy showed significant improvement in the extent of varicose veins, symptomatic and HRQoL parameters. Cost-effectiveness analysis based on the Group 3 trial showed that the surgery produced an estimated discounted benefit of 0.054 quality-adjusted life-year (QALY) over a 2-year period, with an additional discounted cost of pound 387.45, giving an incremental cost-effectiveness ratio (ICER) of pound 7175 per QALY. Economic modelling suggested that surgery produced a still greater benefit when considered with a 10-year time horizon, with an ICER of pound 1936 per QALY. Injection sclerotherapy produced an incremental benefit of approximately 0.044 QALY at a cost of pound 155 when compared with conservative treatment, giving an ICER of pound 3500 per QALY. When surgery was compared with sclerotherapy, surgery produced greater benefit with a lower ICER (showing extended dominance). CONCLUSIONS: Standard surgical treatment of varicose veins by saphenofemoral ligation, stripping and multiple phlebectomies is a clinically effective and cost-effective treatment for varicose veins, with an ICER well below the threshold normally considered appropriate for the funding of treatments within the NHS. Injection sclerotherapy also appears to be cost-effective, but produces less overall benefit, with a higher ICER than surgery for patients with superficial venous reflux. In minor varicose veins without reflux, sclerotherapy is likely to provide a small average benefit with acceptable cost-effectiveness. Research is needed into methods for accurate and acceptable utility evaluations for conditions with relatively minor effect on HRQoL and also for a validated and standardised method of classification for varicose veins.

Cost-effectiveness analysis of surgery versus conservative treatment for uncomplicated varicose veins in a randomized clinical trial.

BACKGROUND: Despite being a common procedure, the cost effectiveness of surgery for varicose veins has not been established. METHODS: Cost-effectiveness analysis was carried out alongside a randomized clinical trial at two vascular units within National Health Service (NHS) hospitals. Some 246 patients with uncomplicated varicose veins and evidence of saphenofemoral or saphenopopliteal reflux were allocated randomly to receive either conservative management or surgical treatment. Incremental cost per quality-adjusted life year (QALY) gained at 24 months following randomization was calculated. RESULTS: Total NHS costs during the 2-year study period were higher for the surgically treated group (733 UK pounds) than for those who had conservative treatment (345 UK pounds). The difference in costs was statistically significant. The mean incremental health gain from surgical treatment at 24 months was 0.083 QALYs, leading to a base-case estimate of 4682 UK pounds per QALY gained. Assuming an implicit threshold maximum willingness-to-pay value of 20 000 UK pounds for a QALY, the probability of surgical treatment for varicose veins falling below this threshold value was 70 per cent. This result was found to be robust to sensitivity analysis. CONCLUSION: For patients with uncomplicated varicose veins and evidence of saphenofemoral or saphenopopliteal reflux, surgical treatment for varicose veins offers a modest health benefit for relatively little additional NHS cost relative to conservative treatment.

Randomized clinical trial comparing surgery with conservative treatment for uncomplicated varicose veins.

BACKGROUND: Surgical treatment of medically uncomplicated varicose veins is common, but its clinical effectiveness remains uncertain. METHODS: A randomized clinical trial was carried out at two large acute National Health Service hospitals in different parts of the UK (Sheffield and Exeter). Some 246 patients were recruited from 536 consecutive referrals to vascular outpatient clinics with uncomplicated varicose veins suitable for surgical treatment. Conservative management, consisting of lifestyle advice, was compared with surgical treatment (flush ligation of sites of reflux, stripping of the long saphenous vein and multiple phlebectomies, as appropriate). Changes in health status were measured using the Short Form (SF) 6D and EuroQol (EQ) 5D, quality of life instruments based on SF-36 and EuroQol, complications of treatment, symptomatic measures, anatomical extent of varicose veins and patient satisfaction. RESULTS: In the first 2 years after treatment there was a significant quality of life benefit for surgery of 0.083 (95 per cent confidence interval (c.i.) 0.005 to 0.16) quality-adjusted life years (QALYs) based on the SF-6D score and 0.13 (95 per cent c.i. 0.016 to 0.25) based on the EQ-5D score. Significant benefits were also seen in symptomatic and anatomical measures. CONCLUSION: Surgical treatment provides symptomatic relief and significant improvements in quality of life in patients referred to secondary care with uncomplicated varicose veins.

Most patients with varicose veins have fears or concerns about the future, in addition to their presenting symptoms.

INTRODUCTION: This study aimed to document fears and concerns of patients about their varicose veins. REPORT: Completed questionnaires about symptoms and concerns were brought to clinic by 62% (203/329) patients referred with uncomplicated primary varicose veins. 'Concerns, worries or fears' about their veins were reported by 79%. These were seldom mentioned in referral letters, and included fears about thrombosis (31%), trauma (16%), ulcers (15%) and general concerns about the future (57%). DISCUSSION: Many patients have unrecognised fears and concerns about their varicose veins. Specific enquiry and reassurance about these is part of good management and may avoid unnecessary treatment.

The clinical effectiveness of hand held Doppler examination for diagnosis of reflux in patients with varicose veins.

OBJECTIVE: To assess the accuracy of hand held Doppler (HHD) as a rapid screening test for selecting varicose vein patients for duplex imaging. DESIGN: Prospective single blind study of consecutive patients in a randomised trial. MATERIALS: Use of hand held Doppler and duplex ultrasound scanners. METHODS: One thousand two hundred and eighteen legs (943 patients) were examined by HHD and then duplex. HHD examiners recorded whether they would normally have requested duplex. RESULTS: HHD results of one Clinical Assistant (166 limbs) were significantly poorer than all others and his results were excluded from analysis. Duplex would not have been requested in 645 of 1052 (62%) limbs. Among these HHD missed significant reflux in the long saphenous vein in 18 (3%) and the short saphenous in 25 (4%). Reasons for requesting duplex were popliteal fossa reflux (202); recurrent (94) or atypical (86) varicose veins; and possible previous thrombosis (67). Differences were observed between staff and units in requests for duplex; and in thoroughness and style of duplex reporting. CONCLUSIONS: Selective use of HHD can avoid duplex imaging for many patients, with a low failure rate for detecting correctable venous reflux. Observed variations between individuals and units in results of HHD and duplex imaging have implications for the increasing use of duplex by clinicians.

Venous ulcer services in the United Kingdom.

OBJECTIVES: To obtain comprehensive information about venous ulcer services throughout the United Kingdom (UK). DESIGN: Questionnaire based survey. MATERIALS: Questionnaire. METHODS: Letters about venous ulcer services were sent to consultant vascular surgeons in all areas of the UK (total 181). Questionnaires were then directed to the appropriate clinician in each area. RESULTS: Responses were received from 177 (98%) areas. Fifteen (8%) had no dedicated service. Completed questionnaires were returned for 112 (63%) areas. Fifty-six (54%) services were managed by acute hospitals, 29 (28%) by primary care (community) and 19 (18%) jointly. Doctors supervised services in 65 (64%) (vascular surgeons 49, dermatologists 12, both 4) and nurses in 31 (33%). New referrals per week were 1-50 based on audit (33%) or estimates (67%). Sixty-three (58%) services had no database. Written guidelines existed for 76% services (90% nurse-supervised and 64% doctor-supervised services--p<0.02). CONCLUSIONS: Dedicated venous ulcer services have been shown to improve healing rates and quality of life. Although now present in most areas of the UK, their organisation varies considerably and many are not based in the community, near patients homes. This survey provides a benchmark for comparison with venous ulcer services in other countries.