Recommended reporting standards for endovenous ablation for the treatment of venous insufficiency: Joint Statement of the American Venous Forum and the Society of Interventional Radiology

Abstract

Lower extremity venous insufficiency is a common medical condition that afflicts approximately 25% of women and 15% of men.1Callam M.J. Epidemiology of varicose veins.Br J Surg. 1994; 81: 167-173Crossref PubMed Scopus (533) Google Scholar Great saphenous vein (GSV) reflux is the most common underlying cause of symptomatic varicose veins. An increasingly popular alternative to traditional surgical stripping of the GSV for management of saphenous vein reflux is endovenous ablation (EVA) of that vein using laser energy, radiofrequency-generated thermal energy, or a chemical sclerosant.2Bone C. Tratamiento endoluminal delas vaarices con laser de diodo: studio preliminary.Rev Patol Vasc. 1999; 5: 35-46Google Scholar, 3Min R.J. Khilnani N. Zimmet S.E. endovenous laser treatment of saphenous vein reflux: long term results.J Vasc Interv Radiol. 2003; 14: 991-996Abstract Full Text Full Text PDF PubMed Scopus (514) Google Scholar, 4Chandler J.G. Pichot O. Sessa C. Schuller-Petrovic S. Osse F.J. Bergan J.J. Defining the role of extended saphenofemoral junction ligation: a prospective comparative study.J Vasc surg. 2000; 32: 941-953Abstract Full Text Full Text PDF PubMed Scopus (138) Google Scholar, 5Merchant R.F. DePalma R.G. Kabnick L.S. Endovascular obliteration of saphenous reflux: a multi-center study.J Vasc Surg. 2002; 35: 1190-1196Abstract Full Text Full Text PDF PubMed Scopus (235) Google Scholar, 6Pichot O. Sessa C. Chandler J.G. Nuta M. Perrin M. Role of duplex imaging in endovenous obliteration for primary venous insufficiency.J Endovasc Ther. 2000; 7: 451-459Crossref PubMed Scopus (51) Google Scholar, 7Kabnick L.S. Merchant R.F. Twelve and twenty-four month follow-up after endovascular obliteration of saphenous vein reflux: a report from the multi-center registry.J Phlebol. 2001; 1: 17-24Google Scholar, 8Lurie F. Creton D. Eklof B. Kabnick L.S. Kistner R.L. Pichot O. Schuller-Petrovic S. Sessa C. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stipping in a selected patient population (EVOLVeS Study).J Vasc Surg. 2003; 38: 207-214Abstract Full Text Full Text PDF PubMed Scopus (361) Google Scholar, 9Lurie F. Creton D. Eklof B. Kabnick L.S. Kistner R.L. Pichot O. et al.Prospective randomized study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up.Eur J Vasc Endovasc Surg. 2005; 29: 67-73Abstract Full Text Full Text PDF PubMed Scopus (291) Google Scholar Comparative studies evaluating long-term EVA clinical treatment outcomes, the optimal timing of adjunctive procedures, and the relative impact of anatomic location, size, length, and energy deposition in the treated segment are expected in the near future. This document provides recommended reporting standards for physicians performing clinical research studies evaluating EVA in the treatment of lower extremity venous reflux and is thereby expected to facilitate comparison between the results of different studies and to improve the overall quality of clinical research on venous disease. These standards have been developed by The Society of Interventional Radiology (SIR) and The American Venous Forum and were approved by the SIR Executive Council on February 28, 2007, and by the AVF Executive Council on February 13, 2007. The general description of the population from which studied groups were selected should be presented. This should include the total number of patients seen and treated at participating institutions during the study period, patients' gender and age distribution, and frequencies of major treatment modalities used. For studies including patients with bilateral disease, both the number of patients and the number of treated limbs, and whether limbs were treated concomitantly or staged must be stated. Baseline patient characteristics should include the level II basic CEAP10Eklof B. Rutherford R.B. Bergan J.J. Carpentier P.H. Gloviczki P. Kistner R.L. et al.American Venous Forum International Ad Hoc Committee for Revision of the CEAP ClassificationRevision of the CEAP classification for chronic venous disorders: consensus statement.J Vasc Surg. 2004; 40: 1248-1252Abstract Full Text Full Text PDF PubMed Scopus (1395) Google Scholar classification (Table I).Table ICEAP classification of chronic venous diseaseClassificationSymptomClinical C0No visible or palpable signs of venous disease C1Telangiectases or reticular veins C2Varicose veins C3Edema C4aPigmentation or eczema C4bLipodermatosclerosis or atrophie blanche C5Healed venous ulcer C6Active venous ulcer SSymptomatic, including ache, pain, tightness, skin irritation, heaviness, and muscle cramps, and other complaints attributable to venous dysfunction AAsymptomaticEtiologic EcCongenital EpPrimary EsSecondary (postthrombotic) EnNo venous cause identifiedAnatomic AsSuperficial veins ApPerforator veins AdDeep veins AnNo venous location identifiedPathophysiologic PrReflux PoObstruction Pr,oReflux and obstruction PnNo venous pathophysiology identifiableLevel of investigation Level IOffice visit, with history and clinical examination, which may include the use of a hand-held Doppler scanner. Level IINoninvasive vascular laboratory testing, which now routinely includes duplex color scanning, with some plethysmographic method added as desired Level IIIInvasive investigations or more complex imaging studies, including ascending and descending venography, venous pressure measurements, computed tomography, or magnetic resonance imaging.ExampleA patient has painful swelling of the leg, and varicose veins, lipodermatosclerosis, and active ulceration. Duplex scanning shows axial reflux of the great saphenous vein above and below the knee, incompetent calf perforator veins, and axial reflux in the femoral and popliteal veins. There are no signs of postthrombotic obstruction.Classification according to basic CEAP: C6,S, Ep, As,p,d, Pr. (2004-05-17, L II). Open table in a new tab Severity of the disease should be reported using validated scales. The Venous Clinical Severity Score (VCSS, Table II) is highly recommended as a measure of overall disease severity.11Rutherford R.B. Padberg Jr, F.T. Comerota A.J. Kistner R.L. Meissner M.H. Moneta G.L. Venous severity scoring: a adjunct to venous outcome assessment.J Vasc Surg. 2000; 31 (Jun): 1307-1312Abstract Full Text Full Text PDF PubMed Scopus (574) Google Scholar, 12Kakkos S.K. Rivera M.A. Matsagas M.I. Lazarides M.K. Robless P. Belcaro G. et al.Validation of the new venous severity scoring system in varicose vein surgery.J Vasc Surg. 2004; 39: 696-697Abstract Full Text Full Text PDF Google Scholar Use of both generic and venous disease-specific measures is the accepted standard for studying quality-of-life (QOL) changes. The Venous Insufficiency Epidemiologic and Economic Study of Quality-of-Life (VEINES-QOL/Sym) questionnaire scale, the Chronic Venous Insufficiency Questionnaire-2 (CIVIQ-2), and the Aberdeen questionnaires have all been validated in patients with lower extremity venous reflux and are highly recommended for use as venous disease–specific QOL measures.13Lamping D.L. Abenhaim L. Kurz X. Schroter S. Kahn S.R. Measuring quality of life and symptoms in chronic venous disorders of the leg: development and psychometric evaluation of the VEINES-QOL/Sym questionnaire.Qual Life Res. 1998; 7: 621-622Google Scholar, 14Lamping D.L. Schroter S. Kurz X. Kahn S.R. Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality-of-life.J Vasc Surg. 2003; 37: 410-419Abstract Full Text PDF PubMed Scopus (240) Google Scholar, 15Smith J.J. Guest M. Greenhalgh R.M. Davies A.H. Measuring the quality of life in patients with venous ulcers.J Vasc Surg. 2000; 31: 642-649Abstract Full Text Full Text PDF PubMed Scopus (139) Google Scholar, 16Franks P.J. Moffatt C.J. Health related quality of life in patients with venous ulceration: use of the Nottingham health profile.Qual Life Res. 2001; 10: 693-700Crossref PubMed Scopus (89) Google Scholar, 17Wiebe S. Guyatt G. Weaver B. Matijevic S. Sidwell C. Comparative responsiveness of generic and specific quality-of-life instruments.J Clin Epidemiol. 2003; 56: 52-60Abstract Full Text Full Text PDF PubMed Scopus (362) Google Scholar, 18Kahn S.R. Milan C.E. Lamping D.L. Kurz X. Bérard A. Abenhaim L.A. VEINES Study GroupRelationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study.J Vasc Surg. 2004; 39: 823-828Abstract Full Text Full Text PDF PubMed Scopus (135) Google Scholar, 19Launois R. Reboul-Marty J. Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ).Qual Life Res. 1996; 5: 539-554Crossref PubMed Scopus (342) Google ScholarTable IIVenous Clinical Severity ScoreAttributeAbsent = 0Mild = 1Moderate = 2Severe = 3PainNoneOccasional, not restricting activity or requiring analgesicsDaily, moderate activity limitation, occasional analgesicsDaily, severe limiting activities or requiring regular use of analgesicsVaricose veinsNoneFew, scattered branch varicose veinsMultiple: GSV varicose veins confined to calf or thighExtensive: thigh and calf or GSV and SSV distributionVenous edemaNoneEvening ankle onlyAfternoon edema, above ankleMorning edema above ankle and requiring activity change, elevationSkin pigmentationNone or focal, low intensity (tan)Diffuse, but limited in area and old (brown)Diffuse over most of gaiter distribution (lower 1/3) or recent pigmentation (purple)Wider distribution (above lower 1/3), recent pigmentationInflammationNoneMild cellulitis, limited to marginal area around ulcerModerate cellulitis, involves most of gaiter area (lower 2/3)Severe cellulitis (lower 1/3 and above) or significant venous eczemaIndurationNoneFocal, circum-malleolar (<5 cm)Medial or lateral, less than lower 1/3 of legEntire lower 1/3 of leg or moreActive ulcers, n012>2Active ulceration durationNone<3 months>3 mo, <1yearNot healed >1 yearActive ulcer, sizeNone<2 cm diameter2-6 cm diameter>6-cm diameterCompressive therapyNot used or not compliantIntermittent use of stockingsWears elastic stockings most daysFull compliance: stockings + elevationGSV, Great saphenous vein; SSV, small saphenous vein Open table in a new tab GSV, Great saphenous vein; SSV, small saphenous vein Because patient satisfaction depends upon addressing his or her chief complaint, the specific primary reason for treatment is also important to indicate. Common symptoms of venous disease include aching, burning, itching, heaviness, swelling, cramping, and local inflammation in the affected limb, among others. A history of superficial or deep venous disease or interventions, or both, may influence both the performance and the results of EVA procedures and is therefore important to describe. Specifically, the following interventions are important: use of graduated compression stockings; a history of venous stripping and/or ligation of truncal veins, ambulatory phlebectomy, sclerotherapy, subfascial endoscopic perforator surgery (SEPS), previous EVA procedures, thrombolysis, angioplasty, or stent placement; or the presence of endovenous devices including stents, inferior vena cava filters, and central venous access devices. The presence of major comorbidities may reduce the clinical success rate or increase the rate of complications, or both. Conversely, exclusion of patient subsets due to morbidity can also bias the population and should be considered when comparing patient cohorts. The following comorbidities may influence the results of EVA and should be reported: coronary artery disease, congestive heart failure, diabetes mellitus, thrombophilias, increased body mass index, and poor overall general health.20Merchant R.F. Pichot O. Long term outcomes of endovenous radiofrequency ablation of saphenous reflux as a treatment for superficial venous insufficiency.J Vasc Surg. 2005; 42: 502-509Abstract Full Text Full Text PDF PubMed Scopus (263) Google Scholar Potential candidates for EVA include patients with reflux in an incompetent GSV or small saphenous vein (SSV) or in a major tributary branch of the GSV or SSV such as the anterior thigh circumflex vein, posterior thigh circumflex vein, or anterior accessory GSV. Therefore, the presence of reflux in these veins is important to document using duplex ultrasound imaging, as pertaining to the CEAP A5 nonsaphenous category. Use of the nomenclature recommended by the International Union of Phlebology, the International Federation of Associations of Anatomists, and the Federative International Committee on Anatomical Terminology is expected.21Caggiati A. Bergan J.J. Gloviczki P. Jantet G. Wendell-Smith C.P. Partsch H. International Interdisciplinary Consensus Committee on Venous Anatomical TerminologyNomenclature of the veins of the lower limbs: an international interdisciplinary consensus statement.J Vasc Surg. 2002; 36: 416-422Abstract Full Text PDF PubMed Scopus (265) Google Scholar, 22Caggiati A. Bergan J.J. Gloviczki P. Eklof B. Allegra C. Partsch H. International Interdisciplinary Consensus Committee on Venous Anatomical TerminologyNomenclature of the veins of the lower limb: extensions, refinements, and clinical application.J Vasc Surg. 2005; 41: 719-724Abstract Full Text Full Text PDF PubMed Scopus (170) Google Scholar Variations to standard venous anatomy, when observed on the ultrasound examination, should be reported. These include tortuosity of the target vein, duplications, atresia, the presence of anatomic venous variants, or variable termination of the SSV. The diameter of the GSV and SSV, ≤2 cm of the junction with the deep vein (common femoral or popliteal) and target vein (if not the GSV or SSV) should be measured. The patient position and site of treatment should be specified. Although a combination of a directed physical examination and duplex ultrasound imaging (CEAP level II examination) is usually sufficient to characterize the anatomic and physiologic extent of lower extremity venous disease,23Min R.J. Khilnani N.M. Golia P. Duplex ultrasound evaluation of lower extremity venous insufficiency.J Vasc Interv Radiol. 2003; 14: 1233-1241Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar diagnosis of chronic venous disorders can also be supported by direct or indirect physiologic tests.24Porter J.M. Rutherford R.B. Clagett G.P. Cranley J.J. O'Donnell T.F. Raju S. et al.Reporting standards in venous disease.J Vasc Surg. 1988; 8: 172-181PubMed Google Scholar, 25Nicolaides A.N. Investigation of chronic venous insufficiency: a consensus statement.Circulation. 2004; 102: E126-E163Crossref Google Scholar When these tests are obtained, the results should be reported. Similarly, when a CEAP level III examination is performed using computed tomography or magnetic resonance imaging, the reason for their use should be specified, the results should be reported, and the specific criteria used for diagnosis of venous abnormalities should be indicated. Definitions of clinical signs and symptoms should comply with definitions presented in the revised CEAP classification.10Eklof B. Rutherford R.B. Bergan J.J. Carpentier P.H. Gloviczki P. Kistner R.L. et al.American Venous Forum International Ad Hoc Committee for Revision of the CEAP ClassificationRevision of the CEAP classification for chronic venous disorders: consensus statement.J Vasc Surg. 2004; 40: 1248-1252Abstract Full Text Full Text PDF PubMed Scopus (1395) Google Scholar Use of the nomenclature recommended by the International Union of Phlebology, the International Federation of Associations of Anatomists, and the Federative International Committee on Anatomical Terminology is expected.21Caggiati A. Bergan J.J. Gloviczki P. Jantet G. Wendell-Smith C.P. Partsch H. International Interdisciplinary Consensus Committee on Venous Anatomical TerminologyNomenclature of the veins of the lower limbs: an international interdisciplinary consensus statement.J Vasc Surg. 2002; 36: 416-422Abstract Full Text PDF PubMed Scopus (265) Google Scholar, 22Caggiati A. Bergan J.J. Gloviczki P. Eklof B. Allegra C. Partsch H. International Interdisciplinary Consensus Committee on Venous Anatomical TerminologyNomenclature of the veins of the lower limb: extensions, refinements, and clinical application.J Vasc Surg. 2005; 41: 719-724Abstract Full Text Full Text PDF PubMed Scopus (170) Google Scholar Specific recommendations include the terms great saphenous vein or GSV (instead of long saphenous vein, greater saphenous vein, or internal saphenous vein) and small saphenous vein or SSV (instead of short saphenous vein, lesser saphenous vein, or external saphenous vein). The ultrasound criteria used to define reflux should be indicated; in current practice, most vascular laboratories consider the presence of venous flow reversal for >0.5 to 1.0 seconds with proximal compression, Valsalva maneuver, or distal compression and release to represent pathologic reflux.23Min R.J. Khilnani N.M. Golia P. Duplex ultrasound evaluation of lower extremity venous insufficiency.J Vasc Interv Radiol. 2003; 14: 1233-1241Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar, 26Van Bemmelen P.S. Bedford G. Beach K. Strandness D.E. Quantitative segmental evaluation of venous valvular reflux with DUS ultrasound scanning.J Vasc Surg. 1989; 10: 425-431PubMed Scopus (396) Google Scholar The aspects of pretreatment preparation that may influence EVA treatment outcomes are important to describe. This includes methods used to increase the distension of the lower extremity veins, such as pretreatment ambulation, patient positioning maneuvers, temperature adjustments to the procedure room, use of tourniquets, or pharmacologic maneuvers such as the administration of vasodilators. The method of marking and mapping the target vein(s) are also important to indicate. The method of venous entry—percutaneous, surgical cutdown, or venotomy—should be stated. Imaging guidance for venous access, administration of anesthetic injections, and monitoring of other aspects of the procedure that is provided by ultrasound guidance, fluoroscopic guidance, or a combination should be reported. The type of access system (eg, micropuncture system vs larger needle) is important to report. The precise location of the percutaneous access site(s) is important to indicate as well as the reason for selection of this point (eg, absence of reflux, potential access difficulties below a certain point, and multiple large tributaries). Tumescent anesthesia is usually administered using a dilute local anesthetic to provide local anesthesia, protect surrounding tissues (including adjacent nerves and overlying skin) from the thermal injury, and mechanically collapse the vein to decrease the distance between the catheter-based heat source and the vein walls and thereby enable nonthrombotic ablation of the vein.3Min R.J. Khilnani N. Zimmet S.E. endovenous laser treatment of saphenous vein reflux: long term results.J Vasc Interv Radiol. 2003; 14: 991-996Abstract Full Text Full Text PDF PubMed Scopus (514) Google Scholar The concentration, volume, and method of administration (ie, hand-injection or mechanical device) of local anesthetic drugs should therefore be described. The use of fluoroscopy or venography must be reported. For thermal ablation techniques, the type of energy (endovenous laser or radiofrequency) along with the manufacturer of the device should be reported. The energy level (power in watts), time of energy deployment (seconds), mode of delivery (pulsed or continuous mode), and total amount of energy emitted must be reported. If a pulsed mode is used during endovenous laser ablation, the duration and frequency of the pulse should be noted. For radiofrequency, temperature of the catheter–vein interface, size of the catheter (6F, 8F), catheter and generator model, rate of catheter pull-back in cm/min, and total treatment time should be reported. For chemical ablation techniques, the concentration, type of sclerosant (including manufacturer), and volume of the sclerosing agent must be reported. If a foam solution is used, the foaming technique should be recorded. The starting point, ending point, and total length of the ablated segment should be reported in a quantitative fashion (eg, from 1 cm below the saphenofemoral junction to 1 cm above the puncture site; total, 40 cm), and for GSV ablation in relation to groin tributaries (ie, below epigastric vein). The type and timing of postprocedure care such as compression therapy should also be reported. The class and type of compression therapy and activity restrictions should be reported. Adjunctive procedures such as sclerotherapy and stab phlebectomies are commonly used in patients undergoing EVA. Because of their influence on treatment outcomes, the use and timing of any adjunctive procedures used at the time of EVA or before the initial outcomes assessment should be described. Administration of sclerosant solution through the vascular sheath encasing the laser or radiofrequency probe should be reported. The type of sclerosant, concentration, volume, and foaming technique for foam sclerotherapy should be noted. It should also be clear whether adjunctive procedures were intended as part of the initial treatment approach. Clinical research studies on EVA may be generally categorized into two types: clinical outcome studies and technology assessment studies. These studies are designed to assess the clinical efficacy and to verify the safety of EVA procedures and are expected to quantify the impact of therapy on clinical outcomes that are meaningful to patients, such as:1relief of presenting symptoms,2frequency of skin ulcer healing and time to recurrence,3prevention of progression of chronic venous insufficiency,4improvement in quality of life, and5improvement in cosmesis, or a combination of these. EVA may succeed in achieving all, some, or none of these goals; similarly, EVA may alleviate all, some, or none of the presenting symptoms. It is therefore important for authors to define the primary clinical intent of the procedure and to adjudicate success or failure by this criterion. The primary clinical intent must be a clinical outcome of importance to patients (eg, relief of the dominant presenting symptom) rather than an anatomic/imaging outcome (eg, ultrasound-proven occlusion of the target vein). Other end points of interest may also be reported, such as the continued need for compression stockings and anti-inflammatory medications after EVA and the need for additional endovenous or surgical procedures. Because causation of clinical outcomes is generally implied as related to treatment, anatomic and imaging outcome at the same follow-up points must be reported. These studies are designed to answer specific technical questions about a new treatment modality before embarking on full-scale clinical outcomes studies. For such studies, it is acceptable to report an anatomic or imaging outcome (eg, successful ultrasound-proven ablation of the target vein) as the primary outcome, but the authors must limit their conclusions accordingly and no mention of clinical efficacy may be made unless a clinical outcome was systematically evaluated. Because the specific goals of therapy will vary among patients, investigators should report outcomes in as many of the following relevant categories as possible. A number of methods may be used to report treatment success in relieving presenting symptoms. In general, the use of validated patient-reported measures of venous symptom status is preferred over “homemade” scales or other subjective assessments. Authors may choose to use disease-specific validated scales designed to provide an assessment of venous symptoms (eg, VEINES-Sym, Aberdeen Varicose Vein Score, and the Charing Cross Venous Ulcer Score). Authors may also focus on objectively documenting improvement in one or more specific symptoms; for example, validated pain scales such as a Likert scale may be used to assess lower extremity pain, although pain and discomfort are routinely addressed in the above QOL measures. Such assessments may be supplemented by objective measures of clinical improvement that are based upon physician assessment of clinical signs (eg, measurement of leg circumferences in standardized fashion for assessment of lower extremity swelling), but determination of treatment success should not rely exclusively on physician assessments because they may or may not correlate with clinical improvement, which is meaningful to patients. Presenting symptoms and QOL may improve rapidly after EVA, but meaningful evaluation of the progression of chronic venous insufficiency needs a significantly longer time. Clinical follow-up should therefore be graded as short-term (<1 year), mid-term (1 to 3 years), or long-term (>3 years). Although the CEAP system is a useful descriptive tool, it is thought to have too many static elements to be effective in monitoring change in disease status with treatment.27Vedantham S. Grassi C.J. Ferral H. Patel N.H. Thorpe P.E. Antonacci V.P. et al.Technology Assessment Committee of the Society of Interventional RadiologyReporting standards for endovascular treatment of lower extremity deep vein thrombosis.J Vasc Interv Radiol. 2006; 17: 417-434Abstract Full Text Full Text PDF PubMed Google Scholar For this reason, a number of alternative scoring systems have been developed and partially validated for assessment of venous disease severity in patients with chronic venous insufficiency. The American Venous Forum has recommended use of the VCSS to quantify the clinical severity of venous disease (Table II). The VCSS is based on physician assessment of the presence and severity of nine common stigmata of chronic venous disease and the use of compression stockings. VCSS scores correlate well with CEAP clinical class and with the presence of abnormalities in the venous system documented with ultrasound imaging.28Rutherford R.B. Padberg F.T. Comerota A.J. Kistner R.L. Meissner M.H. Moneta G.L. Venous outcomes assessment Guidelines of the American Venous Forum.in: Gloviczki P. Yao J.S.T. Handbook of venous disorders. 2nd ed. Arnold, Great Britain2001: 497-508Google Scholar, 29Meissner M. Natiello C.M. Nicholls S.C. Performance characteristics of the Venous Clinical Severity Score.J Vasc Surg. 2002; 36: 889-895Abstract Full Text PDF PubMed Scopus (108) Google Scholar, 30Ricci M.A. Emmerich J. Callas P.W. Rosendaal F.R. Stanley A.C. Naud S. et al.Evaluating chronic venous disease with a new venous severity scoring system.J Vasc Surg. 2003; 38: 909-915Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar For studies that focus primarily on patients with venous ulcers, there also exist measures targeted to this subgroup.15Smith J.J. Guest M. Greenhalgh R.M. Davies A.H. Measuring the quality of life in patients with venous ulcers.J Vasc Surg. 2000; 31: 642-649Abstract Full Text Full Text PDF PubMed Scopus (139) Google Scholar, 16Franks P.J. Moffatt C.J. Health related quality of life in patients with venous ulceration: use of the Nottingham health profile.Qual Life Res. 2001; 10: 693-700Crossref PubMed Scopus (89) Google Scholar It is important to assess QOL in patients with venous insufficiency because it provides valuable information on the patient-perceived burden of illness. When QOL is assessed, a generic QOL measure, such as the Medical Outcomes Study Short Form 36 (SF-36) measure, and a venous disease–specific QOL measure should be used. In recent years, a number of venous disease–specific QOL measures have been developed and at least partly validated; three are listed here:•The VEINES-QOL/Sym consists of 26 question items that measure venous symptoms, limitations in daily activities due to venous disease, psychologic impact of venous disease, and change over time. The VEINES-QOL/Sym has undergone comprehensive and rigorous psychometric evaluation and is acceptable, reliable, valid, and responsive for use as a patient-reported measure of outcome in chronic venous disease.11Rutherford R.B. Padberg Jr, F.T. Comerota A.J. Kistner R.L. Meissner M.H. Moneta G.L. Venous severity scoring: a adjunct to venous outcome assessment.J Vasc Surg. 2000; 31 (Jun): 1307-1312Abstract Full Text Full Text PDF PubMed Scopus (574) Google Scholar, 13Lamping D.L. Abenhaim L. Kurz X. Schroter S. Kahn S.R. Measuring quality of life and symptoms in chronic venous disorders of the leg: development and psychometric evaluation of the VEINES-QOL/Sym questionnaire.Qual Life Res. 1998; 7: 621-622Google Scholar, 17Wiebe S. Guyatt G. Weaver B. Matijevic S. Sidwell C. Comparative responsiveness of generic and specific quality-of-life instruments.J Clin Epidemiol. 2003; 56: 52-60Abstract Full Text Full Text PDF PubMed Scopus (362) Google Scholar•The CIVIQ-2 is a 20-question survey that has been validated for use in patients with chronic venous disease and has been used in a previous randomized trial comparing EVA with surgical therapy.18Kahn S.R. Milan C.E. Lamping D.L. Kurz X. Bérard A. Abenhaim L.A. VEINES Study GroupRelationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study.J Vasc Surg. 2004; 39: 823-828Abstract Full Text Full Text PDF PubMed Scopus (135) Google Scholar, 19Launois R. Reboul-Marty J. Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ).Qual Life Res. 1996; 5: 539-554Crossref PubMed Scopus (342) Google Sch