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National Clinical Guideline Centre (UK). Varicose Veins in the Legs: The Diagnosis and Management of Varicose Veins. London: National Institute for Health and Care Excellence (UK); 2013 Jul. (NICE Clinical Guidelines, No. 168.)

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Varicose Veins in the Legs: The Diagnosis and Management of Varicose Veins.

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Appendix NResearch recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

N.1. Key future research recommendations (FRR)

N.1.1. Natural history of varicose veins

In people with varicose veins at CEAP (Clinical, etiological, anatomical and pathophysiological) stage C2 or C3, what are the factors that influence progression of the disease to CEAP stages C5 or C6?

Why this is important

The evidence review for the guideline showed a lack of high-quality evidence on the progression of varicose veins from CEAP stage C2 or C3 to more serious varicose veins disease. A large observational prospective cohort study, similar to the Framingham or Bonn veins studies, should be undertaken. The study should recruit patients with C2 and C3 disease and follow the progress of their disease over a 5-year time horizon. Consideration should be given to including a genetic component in the study because genetic factors have not been studied on a large scale. The results of such a study should help to more accurately identify which patients are at risk of developing more serious disease so that interventions can be offered at an early stage to those who will benefit most.

Criteria for selecting high-priority research recommendations

CriterionExplanation
Importance to patients or the populationIf the research were to identify clear factors which were indicators for progression to more serious disease, those patients who are most at risk could be identified at an earlier stage and either monitored more closely or treated at an earlier stage. This would then potentially lead to more efficient use of resources.
Relevance to NICE guidanceThis research is of medium relevance to the NICE guidelines. The research is relevant but is not key to future updates as a recommendation was able to be produced in its absence.
Relevance to the NHSThe research is relevant to the NHS, depending on the results it may allow the identification of people at risk, and hence may change the allocation of resources.
National prioritiesThis research is not relevant to a national priority area.
Current evidence baseThe evidence found from the systematic reviews in the guideline were mainly case control and small cohort studies. These are not sufficient to identify all the risk factors. In addition, no large scale study has looked to determine if there is a genetic component involved in the progression of varicose veins.
EqualityThe research would not discriminate against any group.
FeasibilityThe proposed research is a long term project and does have a substantial cost associated with it. However, it was the opinion of the GDG that the potential benefits of the research would outweigh the costs. The issue of treatment needs to be considered. It would not be ethical to prevent patients from having treatment as their disease worsened. Treatment should be taken into account in the research design.
Other commentsNone
Study designProspective cohort study

N.1.2. Optimal interventional and conservative treatments at different stages of disease

What is the optimal treatment (compression, surgery, endothermal ablation or foam sclerotherapy) for varicose veins at each of the CEAP stages, i.e. CEAP stages 2–3, CEAP stage 4 and CEAP stages 5–6?

Why this is important

Much of the research into the optimum treatment for varicose veins has involved patients with varicose veins in CEAP stages C2 and C3, so little is known of the relative efficacies of treatment at the more severe stages of disease. Furthermore, some studies have included patients with varicose veins at a range of stages without subgrouping, which may conceal important differences in efficacy between different treatments at different stages of disease. Hence current treatment recommendations, which do not differentiate between patients with varicose veins at different stages, may not be equally effective to all patients.

A large-scale RCT that compares the 4 main treatments (compression, surgery, endothermal ablation and foam sclerotherapy) in subgroups with varicose veins at different stages is needed. The use of CEAP to categorise the disease stages is not ideal because higher CEAP stages do not necessarily indicate greater severity. However, other methods of categorisation are even more problematic. Quality-of-life measures are unlikely to reflect severity of disease because of variations in perception of symptoms. In addition, measuring the degree of venous reflux would necessitate a method of quantifying reflux in the superficial venous system in a way that adequately reflects disease severity, and such a method does not currently exist. Hence the CEAP categorisation question may be the best choice with a refined quality of life measure.

Criteria for selecting high-priority research recommendations

CriterionExplanation
Importance to patients or the populationIf this trial shows that differing levels of disease severity have different optimal treatments, this will lead to more appropriate and cost-effective treatments for all patients.
Relevance to NICE guidanceThis research is highly relevant to NICE guidance. The answer to this question may change the guidance and the way that varicose veins are treated.
Relevance to the NHSThe impact of this research on the NHS is likely to decrease burden on the NHS as it will mean that the most cost-effective option is used for each disease stage.
National prioritiesThis research is not relevant to any known national priority areas.
Current evidence baseThere have been no studies to date evaluating the optimal treatment strategies for different levels of disease severity.
Relevance to NICE guidanceResults would influence recommendations regarding best management of severe venous dysfunction and with the ESCHAR study would influence the planning of venous services.
Relevance to the NHSLeg ulceration due to superficial venous reflux is a major cause of morbidity and a huge drain on NHS resources. Improved management techniques may influence service delivery and ultimately strategic planning.
National prioritiesNone
Current evidence baseThe RCT ESCHAR study compared surgery and compression with compression alone but it might now be suitable to consider endovenous interventional techniques which being a minimally invasive procedure is more acceptable to patients and may be delivered without delay.
Other commentsThis study has recently been submitted in the form of The Early Venous Reflux Ablation (EVRA) ulcer trial to the National Institute for Health Research. In the ESCHAR study, no improvement in ulcer healing rates was seen, but operative intervention was delayed for a median time of 7 weeks. Recruitment period: 24 months. Study duration: 48 months.
EqualityThe research does not address equality issues as all people will be able to access the intervention.
FeasibilityThe research is expected to be able to be carried out within a realistic timescale and acceptable cost. It is not expected that there would be any ethical or technical issues.
Other commentsNone
Study designRandomised controlled trial
CriterionExplanation
Importance to patients or the populationThis study is important to those patients with CEAP stage C6 disease whose quality of life is substantially reduced by discomfort and social isolation resulting from odour and wound discharge. The social and personal impact of chronic venous leg ulceration is therefore considerable.
EqualityNone identified.
FeasibilityThe proposed research could be carried out within a realistic timescale and at an acceptable cost. No ethical or technical issues?
Study designMulti-centred randomised controlled trial.

N.1.3. Truncal treatment with or without concurrent tributary treatment

Research Question

What is the clinical and cost effectiveness of concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal endothermal ablation for varicose veins compared with:

  • truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy.
  • truncal endothermal ablation with phlebectomies or foam sclerotherappy, if needed, 6–12 weeks later.

Why this is important

Conventional truncal stripping under general anaesthetic involves synchronous phlebectomies of varicose tributaries, and in ultrasound-guided foam sclerotherapy truncal and tributary veins are treated concurrently. In contrast, endothermal ablation may be performed alone to obliterate truncal incompetence, or synchronously with phlebectomies or foam sclerotherapy, and current practice varies.

Synchronous tributary treatment ensures a single treatment episode, and the removal of all symptomatic varicosities leads to a better immediate quality of life, but this takes longer and thus may be associated with increased morbidity. Deferred tributary treatment may reduce morbidity, and also mean that some patients do not need tributary treatment (or need fewer tributary treatments on smaller veins). However, it involves 2 interventions for patients who need tributary treatment. Omitting tributary treatments entirely ensures a single treatment episode, but it is unclear whether remaining varicosities will persist and impair quality of life.

At present there is limited evidence from 1 small-scale (n=50) study on the use and timing of tributary treatments after truncal endothermal ablation. There is a need for practice to be based on empirical evidence from a large and sufficiently powered RCT comparing all 3 main intervention options (no tributary treatment, concurrent tributary treatment and delayed tributary treatment).

Criteria for selecting high-priority research recommendations

CriterionExplanation
Importance to patients or the populationIf the trial showed a benefit of tributary treatment during or after treatment this would lead to altered guidance recommending tributary treatment during or after interventional treatment. This would improve patients’ quality of life.
Relevance to NICE guidanceThis research is of medium importance to the NICE guideline, as the research is relevant to the recommendations in the guideline but the research recommendations are not key to future updates.
Relevance to the NHSThe impact of this research on the NHS is minimal. If the research identified a benefit with tributary treatment during or after treatment a change in recommendation would be required which would lead to a change in practice in the NHS and could reduce costs.
National prioritiesThis research is not relevant to any known national priority areas.
Current evidence baseThe evidence for this section was reviewed in chapter 9e. Only 1 randomised controlled trial was identified in this area. This was not prone to serious bias (unblinded, but clear allocation concealment and no attrition bias) but was possibly underpowered with high levels of imprecision for some outcomes, leading to these outcomes being graded as very low. In addition, this RCT had a short follow-up of only 6 weeks for concurrent tributary treatments vs. no tributary treatment.
EqualityThe research does not address equality issues as all people will be able to access the intervention.
FeasibilityThe research is expected to be able to be carried out within a realistic timescale and acceptable cost. It is not expected that there would be any ethical or technical issues.
Other commentsNone
Study designRandomised controlled trial

N.1.4. Compression as a management option

What is the clinical and cost effectiveness of compression hosiery versus no compression for the management of symptomatic varicose veins?

Why this is important

Compression hosiery is widely used as first-line treatment for symptomatic varicose veins. In some areas of the UK a period of hosiery use is a precursor to referral to secondary care.

Discomfort and difficulty in application may cause people to stop wearing compression hosiery or wear it only occasionally. The current evidence for the benefit of compression hosiery is weak. There is little evidence of an impact on symptom relief or an improvement in quality of life. It is therefore not possible to calculate the cost effectiveness of compression hosiery.

A multicentre trial randomising compression hosiery versus no compression in patients with symptomatic varicose veins is needed. The trial should evaluate quality of life, including symptom reduction, and measure adherence with compression hosiery. In addition the trial should investigate the impact of compression on disease progression and the need for subsequent intervention.

Criteria for selecting high-priority research recommendations

CriterionExplanation
Importance to patients or the populationThe research is important to patients and, if results showed a benefit for compression, clinicians would be confident they were being offered a clinically proven treatment option.
Relevance to NICE guidanceThis research is highly relevant to NICE guidance. The answer to this question may change the guidance and the way that varicose veins are treated. The poor quality current evidence and relatively high costs mean that compression has not been recommended, but if the research were to identify that symptoms of varicose veins were substantially reduced the recommendation may change. Compression might then provide an effective non-interventional management strategy.
Relevance to the NHSWhat would be the impact on the NHS and (where relevant) the public sector of any new or altered guidance (for example, financial advantage, effect on staff, impact on strategic planning or service delivery)?
The research could potentially reduce the variation in practice within the NHS. If the results showed that compression hosiery was effective for the management of varicose veins this would provide a non-interventional management strategy. Conversely, if the research was clear that compression stockings showed little benefit, the NHS could then stop prescribing an ineffective treatment benefit.
In addition, if there was evidence concerning who benefited from compression hosiery, treatment could be better targeted.
`This research is not likely to have an impact on national priorities.
Current evidence baseThe systematic review of the evidence identified 3 low or very low quality RCTs, two of which were completed more than 15 years ago (see section 8.1). These investigated patient assessed symptoms and adverse events but did not look at patients’ quality of life. In addition, 5 observational studies were identified which provided some further information. The GDG felt strongly that the nature of the evidence created much uncertainty about the results for all relevant outcomes.
EqualityEquality issues are not particularly relevant to this research question, although the ability to put on and take off compression hosiery and whether that had an impact in the adherence to the treatment strategy should be considered as part of the research
FeasibilityThe proposed research is considered by the GDG to be feasible and able to be carried out within a realistic timescale and at an acceptable cost. There are no known ethical or technical issues.
Other commentsNone
Study designRandomised Controlled Trial

N.1.5. Compression after interventional treatment

What is the clinical and cost effectiveness of compression bandaging or hosiery after interventional treatment for varicose veins compared with no compression? If there is benefit, how long should compression bandaging or hosiery be worn for?

Why this is important

The benefit of compression after interventional treatment for varicose veins is unclear. A well-conducted multicentre randomised controlled trial (RCT) of compression after interventional treatments would help determine whether compression is beneficial, and if so, what type is best and how long it should be worn for. The trial should include patients who have 1 of the 3 main interventional treatments: endothermal ablation, ultrasound-guided foam sclerotherapy and surgery. The patients should be divided into 3 groups based on the type of intervention they have had. There should be 6 RCT arms, 1 arm with compression and 1 arm without in each of 3 patient groups. Each arm should have subgroups for compression type and duration. Adherence to compression treatment and the impact of adherence on effectiveness should also be evaluated. A cost- effectiveness analysis should be performed. If compression is beneficial, such a trial should help improve quality of life for people with varicose veins and reduce the longer-term need for retreatment.

Criteria for selecting high-priority research recommendations

CriterionExplanation
Importance to patients or the populationIf the trial showed a benefit of compression hosiery after treatment this would lead to altered guidance recommending compression after interventional treatment. This would improve patients’ quality of life.
Relevance to NICE guidanceThis research is of medium importance to the NICE guideline, as the research is relevant to the recommendations in the guideline but the research recommendations are not key to future updates.
Relevance to the NHSThe impact of this research on the NHS is minimal. If the research identified a benefit with compression after interventional treatment a change in recommendation would be required which would lead to a change in practice in the NHS.
National prioritiesThis research is not relevant to any known national priority areas.
Current evidence baseThe evidence for this section was reviewed in chapter 10. Only 2 low/very low quality randomised controlled trials were identified in this area which were both prone to serious bias. In most cases the imprecision of the point estimate was too large to be able to confidently judge the magnitude/direction of the true population effect.
EqualityThe research does not address equality issues as all people will be able to access the intervention. Patient compliance with compression should be assessed in the research to determine if there are any factors which meant that compression was not suitable for specific groups.
FeasibilityThe research is expected to be able to be carried out within a realistic timescale and acceptable cost. It is not expected that there would be any ethical or technical issues.
Other commentsNone
Study designRandomised controlled trial
Copyright © National Clinical Guideline Centre (July 2013)
Bookshelf ID: NBK328024

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