Greater Manchester EUR Policy Statement. Title/Topic: Varicose Veins Reference: GM003 Date: January 2015

Transcription

1 Greater Manchester EUR Policy Statement Title/Topic: Varicose Veins Reference: GM003 Date: January 2015

2 VERSION CONTROL Version Date Details Page number /10/2013 Initial Draft for consideration by GM EUR Steering Group N/A /02/2014 Appendix 2 added Varicose Vein Referral Threshold Tool Thread veins and Spider Naevus/Telangiectasia are included within the GM013 Dermatology Minor Surgery policy inserted in policy exclusions section /03/2014 Amendments made by GM EUR Steering Group on 19/03/2014: Criteria for commissioning revised in accordance with GM EUR Steering Group recommendations. Removal of Varicose Vein Referral Threshold Tool Appendix 2 Inclusion of GM013 Benign Skin Lesion EUR Policy under section 12 - links to other policies /04/2014 Statement regarding treating disabled people as more equal than other protected characteristic groups added to Equality and Equity section. Ratification through CCG Governing Bodies added to Governance Arrangements /05/2014 Amendments made by GM EUR Steering Group on 21/05/2014: 09/07/ /09/2014 Aberdeen Score changed to Venous Clinical Severity Score. The first 2 bullet points in the mandatory criteria should be specified as an urgent referral. Reference to NICE 168 guidance further defined, and includes an explanation of why the policy does not fully comply with NICE guidance. Appendix 2: Venous Clinical Severity Score added. Draft policy approved for consultation following the above amendments. Policy published for consultation from 09/07/2014 to 03/09/2014. Feedback from consultation reviewed by the GM EUR Steering Group. No amendments required. Policy approved by GM EUR Steering Group N/A N/A N/A N/A /10/2014 Branding Changed following creation of North West CSU on All GM Varicose Veins Policy v1.3 FINAL Page 2 of 19

3 01/10/ /09/2014 Policy approved by GM EUR Steering Group. N/A /03/ /06/ /04/ /04/2016 Bolton CCG adopted funding mechanism of IPA for all requests. Variance column removed and funding mechanism column added to table. Format of funding mechanism changed. List of diagnostic and procedure codes in relation to this policy added as Appendix 3. Policy changed to Greater Manchester Shared Services template and references to North West Commissioning Support Unit changed to Greater Manchester Shared Services. Funding mechanism for Bolton CCG changed from Individual Prior Approval for all requests to Monitored Approval for severe varicose veins and Individual Prior Approval for moderate varicose veins in line with the rest of GM. Wording for date of review amended to read One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years) on Policy Statement and section 13. Date of Review N/A 5 & 10 4 & /06/2016 Wigan CCG changed funding mechanism to Individual Prior Approval (IPA) for severe varicose veins to be adopted from 1 st August & 11 GM Varicose Veins Policy v1.3 FINAL Page 3 of 19

4 POLICY STATEMENT Title/Topic: Varicose Veins Issue Date: January 2015 Commissioning Recommendation: Severe Varicose Veins Referral to a vascular service should take place for patients with severe varicose veins these are varicose veins that are associated with one of the following: They are bleeding from a varicosity that has eroded the skin. They have bled from a varicosity and are at risk of bleeding again. Note: If either of the above are present the patient should be referred as a matter of urgency. They have an ulcer which is progressive and/or painful. They have a stable, pain-free, ulcer and/or progressive skin changes indicative of varicose eczema that may benefit from surgery. The above should be accompanied by a Venous Clinical Severity Score which would be expected to be 9 or more. Moderate Varicose Veins Patients with moderate varicose veins (symptoms, include: Itching, aching, mild swelling, and the minor skin changes of eczema haemosiderosis) may be considered for surgery if there is objective evidence of rapid worsening of the condition. Funding approval must be obtained prior to referral. Serial Venous Clinical Severity Scores should be included with the funding request, detailing the worsening of symptoms. See Section 4: Criteria for Commissioning Date of Review: One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years). Prepared By: Greater Manchester Shared Services Effective Use of Resources Policy Team GM Varicose Veins Policy v1.3 FINAL Page 4 of 19

5 Approved By Date Approved Funding Mechanism Greater Manchester Effective Use of Resources Steering Group 17/09/2014 GM EUR Steering Group recommended funding mechanism: For severe varicose veins will be monitored approval and referrals may be made and accepted in line with the criteria detailed in the policy. Note: Excluding Wigan CCG which will be Individual Prior Approval (IPA) from 1 st August Funding for moderate varicose veins will be Individual Prior Approval. Funding approval should be obtained via the IFR route prior to referral. Greater Manchester Chief Finance Officers / Greater Manchester Heads of Commissioning Greater Manchester Association Governing Group 15/12/2014 N/A 06/01/2015 N/A Bury Clinical Commissioning Group 04/03/2015 Recommended mechanism above Bolton Clinical Commissioning Group 27/03/2015 Recommended mechanism above Heywood, Middleton & Rochdale Clinical Commissioning Group Central Manchester Clinical Commissioning Group North Manchester Clinical Commissioning Group 20/03/2015 Recommended mechanism above 05/03/2015 Recommended mechanism above 13/01/2015 Recommended mechanism above Oldham Clinical Commissioning Group 06/01/2015 Recommended mechanism above Salford Clinical Commissioning Group 06/01/2015 Recommended mechanism above South Manchester Clinical Commissioning Group 11/03/2015 Recommended mechanism above Stockport Clinical Commissioning Group 25/02/2015 Recommended mechanism above Tameside & Glossop Clinical Commissioning Group 22/04/2015 Recommended mechanism above Trafford Clinical Commissioning Group 17/03/2015 Recommended mechanism above Wigan Borough Clinical Commissioning Group 04/03/2015 Individual Prior Approval (IPA) for all requests (both severe and moderate varicose veins) from 1 st August GM Varicose Veins Policy v1.3 FINAL Page 5 of 19

6 CONTENTS Policy Statement... 7 Equality & Equity Statement... 7 Governance Arrangements Introduction Definition Aims and Objectives Criteria for Commissioning Description of Epidemiology and Need Evidence Summary Rationale behind the Policy Statement Adherence to NICE Guidance Mechanism for Funding Audit Requirements Documents which have informed this Policy Links to other Policies Date of Review Glossary References Appendix 1 Evidence Review Appendix 2 Venous Clinical Severity Score Appendix 3 Diagnostic and Procedure Codes GM Varicose Veins Policy v1.3 FINAL Page 6 of 19

7 Policy Statement The Greater Manchester Shared Services (GMSS) has developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission the investigation and treatment of varicose veins in accordance with the criteria outlined in this document. In creating this policy the GMCSU has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. Equality & Equity Statement The GMSS/CCG has a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act The GMSS/CCG is committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex (gender) or sexual orientation. In carrying out its functions, the GMSS/CCG will have due regard to the different needs of protected characteristic groups, in line with the Equality Act This document is compliant with the NHS Constitution and the Human Rights Act This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMSS policy team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their starting point is considered to be further back than any other group. This will be reflected in GMSS evidencing taking due regard for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmscu@nhs.net. Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Association Governing Group (AGG) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the Greater Manchester EUR Operational Policy. 1. Introduction This commissioning policy has been produced in order to provide and ensure equity, consistency and clarity in the commissioning of services to investigate and treat varicose veins by Clinical Commissioning Groups in Greater Manchester. When this policy is reviewed all available additional data on outcomes will be included in the review and the policy updated accordingly. NICE CG 168 radically altered the treatment pathway for varicose veins. This policy has been developed to reflect the updated pathway. GM Varicose Veins Policy v1.3 FINAL Page 7 of 19

8 2. Definition In some people varicose veins are asymptomatic or cause only mild symptoms, but in others they cause pain, aching or itching and can have a significant effect on their quality of life. Varicose veins can cause skin changes, varicose eczema and varicose ulceration. Bleeding or thrombophlebitis may also occur. Previous PCT commissioning policies for varicose veins required that all patients had undergone conservative management including the use of compression stockings and that only those with severe varicose veins should be referred for surgery. This guidance recognises a desire to move towards commissioning a service for the treatment of varicose veins based on NICE CG 168 but recognises that before this can happen there is a need to ensure that all stages of the pathway identified in NICE 168 are available locally and that patients are managed in line with that guidance. Until the pathway and supporting commissioning work is completed then patients should be referred using the criteria listed below. 3. Aims and Objectives Aim This policy document aims to specify the conditions under which varicose veins will be routinely commissioned by Clinical Commissioning Groups in Greater Manchester. Objectives To reduce the variation in access to services for the assessment and diagnosis of varicose veins. To ensure that treatment for varicose veins is commissioned based on acceptable evidence of clinical benefit and cost-effectiveness and are not commissioned where there is evidence to the contrary. To reduce unacceptable variation in the commissioning of treatments for varicose veins across Greater Manchester. To promote the cost-effective use of healthcare resources. To move to commissioning services to treat symptomatic varicose veins in line with NICE 168 when pathway redesign work has been undertaken and completed. 4. Criteria for Commissioning Severe Varicose Veins Referral to a vascular service should take place for patients with severe varicose veins these are varicose veins that are associated with one of the following: They are bleeding from a varicosity that has eroded the skin. They have bled from a varicosity and are at risk of bleeding again. NOTE: If either of the above are present the patient should be referred as a matter of urgency. They have an ulcer which is progressive and/or painful. They have a stable, pain-free, ulcer and/or progressive skin changes indicative of varicose eczema that may benefit from surgery. The above should be accompanied by a Venous Clinical Severity Score of 9 or more. GM Varicose Veins Policy v1.3 FINAL Page 8 of 19

9 Moderate Varicose Veins Patients with moderate varicose veins (symptoms, include: itching, aching, mild swelling, and the minor skin changes of eczema haemosiderosis) may be considered for surgery if there is objective evidence of rapid worsening of the condition. Funding approval must be obtained prior to referral. Serial Venous Clinical Severity Scores should be included with the funding request, detailing the worsening of symptoms. On referral duplex ultrasound to confirm the diagnosis and determine the presence and extent of truncal reflux should be undertaken prior to invasive treatment being undertaken. Treatment should be offered as follows: 1. First offer endothermal ablation (NICE IPG 8 and 52). 2. If endothermal ablation is unsuitable offer ultrasound guided foam sclerotherapy (NICE IPG 440). 3. If ultrasound guided foam sclerotherapy is unsuitable then offer surgery. Note: If incompetent varicose tributaries are to be treated, consider treating them at the same time. If compression hosiery or bandaging is offered do not use for more than 7 days. Do not use compression hosiery to treat varicose veins unless interventional treatment is not suitable. Do not carry out interventional treatment of varicose veins during pregnancy except in exceptional circumstances. Policy Exclusions Thread veins and Spider Naevus/Telangiectasia are included within the GM013 Dermatology Minor Surgery policy. Treatment in line with the criteria outlined above is routinely commissioned. For patients outside of the groups described above, funding for investigation and treatment may be considered on an individual patient basis if there is evidence of clinical exceptional circumstances. Clinicians can submit an Individual Funding Request (IFR) if they feel there is a good case for clinical exceptionality. Exceptionality means a person to which the general rule is not applicable. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: Significantly different to the general population of patients with the condition in question. and as a result of that difference They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. GM Varicose Veins Policy v1.3 FINAL Page 9 of 19

10 5. Description of Epidemiology and Need Varicose veins are dilated, often palpable subcutaneous veins with reversed blood flow. They are most commonly found in the legs. Estimates of the prevalence of varicose veins vary. Visible varicose veins in the lower limbs are estimated to affect at least a third of the population. Risk factors for developing varicose veins are unclear, although prevalence rises with age and they often develop during pregnancy. In some people, varicose veins are asymptomatic or cause only mild symptoms, but in others they cause pain, aching or itching and can have a significant effect on their quality of life. Varicose veins may become more severe over time and can lead to complications such as changes in skin pigmentation, bleeding or venous ulceration. It is not known which people will develop more severe disease but it is estimated that 3-6% of people who have varicose veins in their lifetime will develop venous ulcers. Health Technology Assessment NHS R&D HTA Programme Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial) estimated that the prevalence of visible varicose veins in Europe and the USA is approximately 25-30% for adult women and approximately 15% for men. 6. Evidence Summary An initial search was carried out of NHS evidence, NICE Guidance and SIGN, as well as BMJ Best Practice and BMJ clinical evidence and the Royal College of Surgeons databases. The results of this search are summarised in the Search Strategy table in Appendix 1. Full details of the Evidence Review are contained with Appendix Rationale behind the Policy Statement To consolidate current commissioning arrangements across Greater Manchester and to begin the shift towards commissioning these services in line with NICE CG Adherence to NICE Guidance In drafting these guidelines it was noted that NICE CG 168 recommends that all symptomatic varicose veins should be referred for investigation and, where appropriate, treatment. Current resources cannot meet the demand that this would generate either in the commissioning costs associated with implementing the NICE pathway, or in the capacity to undertake Doppler examinations etc. These guidelines are intended as a holding position whilst the required pathway and contracting changes have been made to enable seamless adoption of NICE CG Mechanism for Funding Clinical Commissioning Group Bolton Bury Heywood, Middleton & Rochdale Manchester Central Manchester North Manchester South Oldham Salford Stockport Funding Mechanism For severe varicose veins will be monitored approval and referrals may be made and accepted in line with the criteria detailed in the policy. Funding for moderate varicose veins will be Individual Prior Approval. Funding approval should be obtained via the IFR route prior to referral. GM Varicose Veins Policy v1.3 FINAL Page 10 of 19

11 Tameside & Glossop Trafford Wigan Individual Prior Approval (IPA) for all requests (both severe and moderate varicose veins) from 1 st August Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. 11. Documents which have informed this Policy Greater Manchester EUR Operational Policy 12. Links to other Policies This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). GM013: Benign Skin Lesion EUR Policy 13. Date of Review One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years). 14. Glossary Term BMJ Endothermal Ablation Exceptionality Foam Sclerotherapy NICE SIGN Varicose Veins Meaning British Medical Journal Energy from either from high-frequency radio waves (radiofrequency ablation) or lasers (endovenous laser treatment) is used to seal the affected veins. A person to which the general rule is not applicable (see policy exclusions sections above for a detailed definition). The injection of a special foam into the veins, which scars the veins and seals them closed. National Institute for Health and Care Excellence Scottish Intercollegiate Guidelines Network Varicose veins are dilated, often palpable subcutaneous veins with reversed blood flow. They are most commonly found in the legs. References 1. NICE Clinical Guidance 168 (IPG 8, 52 and 440) 2. The University of York Centre for Dissemination and reviews GM Varicose Veins Policy v1.3 FINAL Page 11 of 19

12 3. BMJ Reviews Clinical Evidence review Varicose Veins Paul V Tisi January Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: Short-term results Lars H. Rasmussen, MD, DMSC, Lars Bjoern, MD, Martin Lawaetz, BS, Allan Blemings, MSc, Birgit Lawaetz, RN, and Bo Eklof, MD, PhD, Naestved and Roskilde, Denmark ( J Vasc Surg 2007;46: ) 5. Cochrane Collaboration. Compression stockings for the initial treatment of varicose veins in patients without venous ulceration Shingler S et al, The Cochrane library 2011, issue 11 GM Varicose Veins Policy v1.3 FINAL Page 12 of 19

13 Appendix 1 Evidence Review Title/Topic: Varicose Veins Ref: GM003 Search Strategy Database NICE (includes NHS Evidence) SIGN Cochrane York Result CG 168 Ultrasound foam sclerotherapy IPG 8, 52, 440 SIGN Chronic venous leg ulcer Compression Stocking review A systematic review and meta-analysis of the treatment of VVs BMJ Clinical Evidence Clinical Evidence review Varicose veins P V Tisi January 2010 BMJ Best Practice Not undertaken due to number of results found elsewhere. General Search (Google) Gonadal Vein Embolization: Treatment of Varicocele and Pelvic Congestion Syndrome Mark A. Bittles, M.D.,1 and Eric K. Hoffer, M.D.2 Medline / Open Athens Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: Short-term results Lars H. Rasmussen, MD, DMSC, Lars Bjoern, MD, Martin Lawaetz, BS, Allan Blemings, MSc, Birgit Lawaetz, RN, and Bo Eklof, MD, PhD, Naestved and Roskilde, Denmark Rtyutyu Evidence based clinical practice guidelines: chronic wounds of the lower extremity. American society of plastic surgeons. Randomised clinical trial, observational study and assessment of costeffectiveness of the treatment of varicose veins (REACTIV trial) JA Michaels et al Health Technology Assessment NHS R&D HTA Programme April 2006 Summary of the evidence There were a lot of evidence reviews and guidelines covering this topic. However, the papers cited within these were often of low quality, i.e. Level 3-5. The evidence Levels of evidence Level 1 Level 2 Level 3 Meta-analyses, systematic reviews of randomised controlled trials Randomised controlled trials Case-control or cohort studies GM Varicose Veins Policy v1.3 FINAL Page 13 of 19

14 Level 4 Level 5 Non-analytic studies e.g. case reports, case series Expert opinion 1. LEVEL 1: SYSTEMATIC REVIEW NICE Clinical Guidance 168 NICE carried out a review of the evidence and based their recommendations on the best available evidence whilst acknowledging that a lot more evidence based research was needed. The evidence review for the guideline showed a lack of high quality evidence on the natural progression of varicose veins. It found that the current evidence for the use of compression hosiery was weak and that the evidence for its use after interventional treatment was unclear. It found one small scale study (n=50) on the use and timing of tributary treatment after truncl endothermal ablation. It also found that most of the research into the optimum treatment for varicose veins involved patients at stage C2 and C3 so little is known of the relative efficacies of the treatments at the more severe stages of the disease. 2. LEVEL 1: SYSTEMATIC REVIEW AND META-ANALYSIS The University of York Centre for Dissemination and reviews The review found that, based on low quality evidence, available treatments for varicose veins appeared safe and surgery appeared effective long term. Less invasive treatments caused less periprocedural disability and pain but their effectiveness was supported only by short-term studies. These conclusions require some caution in interpretation due to large differences between the included studies. 3. LEVEL 1: SYSTEMATIC REVIEW BMJ Reviews Clinical Evidence Review Varicose Veins Paul V Tisi January 2010 They found 39 systematic reviews, RCTs, or observational studies that met their inclusion criteria. They performed a GRADE evaluation of the quality of evidence for interventions and they presented information relating to the effectiveness and safety of the following interventions: compression stockings, endovenous laser, injection sclerotherapy, radiofrequency ablation, self-help (advice, avoidance of tight clothing, diet, elevation of legs, exercise), and surgery (stripping, avulsion, powered phlebectomy). 4. Level 2: Randomised Controlled Trial Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: Short-term results Lars H. Rasmussen, MD, DMSC, Lars Bjoern, MD, Martin Lawaetz, BS, Allan Blemings, MSc, Birgit Lawaetz, RN, and Bo Eklof, MD, PhD, Naestved and Roskilde, Denmark ( J Vasc Surg 2007;46: ) Abstract: Background: Endovenous laser (EVL) ablation of the great saphenous vein (GSV) is thought to minimize postoperative morbidity and reduce work loss compared with high ligation and stripping (HL/S). GM Varicose Veins Policy v1.3 FINAL Page 14 of 19

15 However, the procedures have not previously been compared in a randomized trial with parallel groups where both treatments were performed in tumescent anesthesia on an out-patient basis. Methods: Patients with varicose veins due to GSV insufficiency were randomized to either EVL (980 nm) or HL/S in tumescent anesthesia. Miniphlebectomies were also performed. Patients were examined preoperatively and at 12 days, and 1, 3, and 6 months postoperatively. Sick leave, time to normal physical activity, pain score, use of analgesics, Aberdeen score, Medical Outcomes Study Short Form- 36 quality-of-life score, Venous Clinical Severity Score (VCSS), and complication rates were investigated. The total cost of the procedures, including lost wages and equipment, was calculated. Cost calculations were based on the standard fee for HL/S with the addition of laser equipment and the standard salary and productivity level in Denmark. Results: A follow-up of 6 months was achieved in 121 patients (137 legs). The groups were well matched for patient and GSV characteristics. Two HL/S procedures failed, and three GSVs recanalized in the EVL group. The groups experienced similar improvement in quality-of-life scores and VCSS score at 3 months. Only one patient in the HL/S group had a major complication, a wound infection that was treated successfully with antibiotics. The HL/S and EVL groups did not differ in mean time to resume normal physical activity (7.7 vs 6.9 calendar days) and work (7.6 vs 7.0 calendar days). Postoperative pain and bruising was higher in the HL/S group, but no difference in the use of analgesics was recorded. The total cost of the procedures, including lost wages, was 3084 ($3948 US) in the HL/S and 3396 ($4347 US) in the EVL group. Conclusions: This study suggests that the short-term efficacy and safety of EVL and HL/S are similar. Except for slightly increased postoperative pain and bruising in the HL/S group, no differences were found between the two treatment modalities. The treatments were equally safe and efficient in eliminating GSV reflux, alleviating symptoms and signs of GSV varicosities, and improving quality of life. Long-term outcomes, particularly with respect to recurrence rates, shall be investigated in future studies, including the continuation of the present. 5. LEVEL 1: SYSTEMATIC REVIEW Cochrane Collaboration Compression stockings for the initial treatment of varicose veins in patients without venous ulceration Shingler S et al, The Cochrane library 2011, issue 11 Background: Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. Objectives: To assess the effectiveness of compression stockings for the initial treatment of varicose veins in patients without healed or active venous ulceration. Search methods: The Cochrane Peripheral Vascular Disease Group searched their Specialised Register (last searched 31 May 2011) and CENTRAL (2011, Issue 2). In addition, the reference lists of relevant articles were searched. Authors of ongoing and current trials were contacted. There were no language restrictions. Selection criteria: Randomised controlled trials (RCTs) were included if they involved participants diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment, compression versus placebo stockings, or compression stockings + drug intervention versus drug intervention alone. Trials comparing different lengths and pressures of stockings were also included. Trials involving other types of treatment for varicose veins GM Varicose Veins Policy v1.3 FINAL Page 15 of 19

16 (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery, were excluded. Data collection and analysis: Two authors assessed the trials for inclusion and quality (SS and LR). SS extracted the data, which were checked by LR. Attempts were made to contact trial authors where missing or unclear data were present. Main results: Seven studies involving 356 participants with varicose veins without healed or active venous ulceration were included. Different levels of pressure were exerted by the stockings in the studies, ranging from 10 to 50 mmhg. One study assessed compression hosiery versus no compression hosiery. The other six compared different types or pressures of stockings. The methodological quality of all included trials was unclear, mainly because of inadequate reporting. The symptoms subjectively improved with the wearing of stockings across trials that assessed this outcome, but these assessments were not made by comparing one randomised arm of a trial with a control arm and are therefore subject to bias. Meta-analyses were not undertaken due to inadequate reporting and actual or suspected high levels of heterogeneity. Authors conclusions: There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of a large RCT of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place. GM Varicose Veins Policy v1.3 FINAL Page 16 of 19

17 Appendix 2 Venous Clinical Severity Score Attribute Absent = 0 Mild = 1 Moderate = 2 Severe = 3 Pain None Occasional, not restricting activity or requiring pain medication Daily moderate activity limitation; occasional pain medication Daily, severe limiting activities or requiring regular use of pain medications Varicose Veins None Few scattered Multiple; great saphenous veins, confined to calf and thigh Extensive; thigh and calf or great and small saphenous distribution Venous Edema None Evening ankle swelling only Skin Pigmentation None Diffuse, but limited in area and old (brown) Inflammation None Mild cellulitis, limited to marginal area around ulcer Afternoon swelling, above ankle Diffuse over most of gaiter distribution (lower third) or recent pigmentation (purple) Moderate cellulitis, involves most of (lower third) Morning swelling above ankle and requiring activity change, elevation Wider distribution (above lower third) plus recent pigmentation Severe cellulitis (lower third and above) or significant Induration None Focal, circummalleolar Medial or lateral, less than lower third of leg Entire lower third of leg or more Number of Active Ulcers Active Ulcer Duration Active Ulcer Diameter >2 None <3 months >3 months, <1 year Not healed>1 Year None <2 2-6 >6 Compression Therapy Not used or patient not compliant Intermittent use of stockings Wears elastic stocking most days Full compliance, stockings + elevation GM Varicose Veins Policy v1.3 FINAL Page 17 of 19

18 Appendix 3 Diagnostic and Procedure Codes (All codes have been verified by Mersey Internal Audit s Clinical Coding Academy) GM003 - Varicose Veins Policy Combined operations on primary long saphenous vein L84.1 Combined operations on primary short saphenous vein L84.2 Combined operations on primary long and short saphenous vein L84.3 Combined operations on recurrent long saphenous vein L84.4 Combined operations on recurrent short saphenous vein L84.5 Combined operations on recurrent long and short saphenous vein L84.6 Other specified combined operations on varicose vein of leg L84.8 Unspecified combined operations on varicose vein of leg L84.9 Ligation of long saphenous vein L85.1 Ligation of short saphenous vein L85.2 Ligation of recurrent varicose vein of leg L85.3 Other specified ligation of varicose vein of leg L85.8 Unspecified ligation of varicose vein of leg L85.9 Injection of sclerosing substance into varicose vein of leg NEC L86.1 Ultrasound guided foam sclerotherapy for varicose vein of leg L86.2 Unspecified injection into varicose vein of leg L86.9 Stripping of long saphenous vein L87.1 Stripping of short saphenous vein L87.2 Avulsion of varicose vein of leg L87.4 Local excision of varicose vein of leg L87.5 Transilluminated powered phlebectomy of varicose vein of leg L87.7 Other specified other operations on varicose vein of leg L87.8 Percutaneous transluminal laser ablation of long saphenous vein L88.1 Radiofrequency ablation of varicose vein of leg L88.2 Percutaneous transluminal laser ablation of varicose vein of leg NEC L88.3 Unspecified transluminal operations on varicose vein of leg L88.9 With the following ICD-10 diagnosis code(s): Varicose veins of lower extremities with ulcer I83.0 GM Varicose Veins Policy v1.3 FINAL Page 18 of 19

19 Varicose veins of lower extremities with inflammation I83.1 Varicose veins of lower extremities with both ulcer and inflammation I83.2 Varicose veins of lower extremities without ulcer or inflammation I83.9 GM Varicose Veins Policy v1.3 FINAL Page 19 of 19