Validation of a Swedish version of a short patient-reported outcome measure for superficial venous insufficiency.

OBJECTIVE: Patient-reported outcome measures (PROMs) are increasingly used to measure symptoms and treatment effects, and a short PROM is more user friendly. The aim of this study was to test whether a Swedish seven-item version of the PROM used in the Vascular Quality Initiative Varicose Vein Registry can be used to measure quality of life in a Swedish cohort of patients with superficial venous insufficiency (SVI) equally well as the 26-item Swedish version of the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym-S) and measure treatment effect. METHODS: Consecutive patients with SVI and Clinical-Etiology-Anatomy-Pathophysiology (CEAP) clinical class ≥C2 were recruited at three private clinics and one county hospital between January 2018 and October 2019. The patients were asked to answer both the VEINES-QOL/Sym-S and the Swedish seven-item version, called VARIShort, at two assessment points, baseline (cohort 1, 252 patients) and 1 week later (cohort 2, 138 patients), and the VARIShort at baseline and 8 weeks after an endovenous procedure (cohort 3, 106 patients). The mean age was 58.3 years (range, 20-93 years), 61.4 years (range, 20-93 years), and 57.2 years (range, 20-89 years) in cohorts 1, 2, and 3, respectively; the majority were female (59%, 55%, and 64%), and most were CEAP C4 (39%, 46%, and 38%). The VARIShort was evaluated with regard to its validity, test-retest reliability, internal consistency reliability, sensitivity, and responsiveness. RESULTS: There was a strong correlation between the VEINES-QOL-S and the VARIShort (rs = -0.819; P < .001). The VARIShort showed both excellent internal consistency with Cronbach's α of 0.93 and a high response to clinical change as measured with Cohen's d, overall score of 1.17. CONCLUSIONS: The Swedish seven-item PROM, the VARIShort, may be used for assessment of symptoms of SVI and outcome after treatment in Swedish SVI patients. The short PROM shows degree of SVI symptom impact on quality of life in the same manner as the 26-item VEINES-QOL/Sym-S.

Resilience, trust, and civic engagement in the post-CCSVI era.

BACKGROUND: Scientific and financial investments in chronic cerebrospinal venous insufficiency (CCSVI) research have been made to address both the hope for and scepticism over this interventional strategy for MS. Despite limited evidence in support of the CCSVI hypothesis, the funding of clinical research was responsive to a demand by the public rarely seen in the history of medicine. We characterize patient perspectives about the CCSVI research trajectory, with particular attention to its impact on other non-pharmaceutical areas of MS research with a focus on stem cell interventions. METHODS: Semi-structured interviews with 20 MS patients across Canada who did not have CCSVI interventions. Interviews were analysed for recurring themes and individual variations using the constant comparative approach. RESULTS: Participants had a critical view of the divestment of funds from longstanding research to support CCSVI trials. They retain a sense of optimism, however, about emerging evidence for stem cell interventions for MS, and highlight the need for greater caution and conscientious communication of advances in medicine and science. CONCLUSIONS: The unrealized hopes for CCSVI challenged but did not undermine the resilience of patient communities. The narrative that unfolded highlights the importance of drawing a socially-minded space for public participation in science.

[Sulodexide in treatment of chronic venous insufficiency. Results of the All-Russian multicenter programme ACVEDUCT]. / Sulodeksid v lechenii khronicheskoi venoznoi nedostatochnosti. Itogi Vserossiiskoi mul'titsentrovoi programmy ACVEDUCT.

INTRODUCTION: Pharmacotherapy occupies one of the leading places in comprehensive treatment of lower-limb chronic venous diseases (CVD) and their complications. At the same time, there are not so many therapeutic agents intended for treatment of CVD and possessing evidence-based efficacy. Sulodexide (registered in Russia as Vessel Due F) is a drug with a confirmed therapeutic effect in patients with a moderately severe course of chronic venous disease or its late stages. However, the experience of using it in Russia for treatment of patients presenting with initial manifestations of chronic venous insufficiency (CVI) is still scarce. PATIENTS AND METHODS: The data concerning the use of Vessel Due F in the routine practice of treating CVD in Russian patients were collected and assessed within the framework of the ACVEDUCT programme. This observational prospective non-controlled multicentre programme included patients routinely prescribed by their attending physician Vessel Due F as a solution for injections and/or soft capsules in accordance with the registered in the Russian Federation instruction for use. A total of 2,263 patients took part in the programme. RESULTS: The majority of the patients prescribed sulodexide were diagnosed as having CEAP class C3 (38.4%) and class C4 (35.6%) CVD. Treatment was accompanied and followed by a decrease in the symptoms' severity observed in 56.4% of patients and a decrease in the number of symptoms in 42.8% of patients (thus positive dynamics was totally noted in 99.2%), with the effect of taking the drug commencing to manifest itself in patients as early as on day 15-20 of treatment. The highest rate of regression of symptoms of CVD was observed in 30-to-40-year-old patients. A statistically significant positive correlation was revealed between efficacy and the duration of treatment, the use of capsules during the term of follow up, with a negative correlation revealed between efficacy of treatment and the patient's age at which the diagnosis had been made, the stage according the CEAP classification, the total number of symptoms, a combination of risk factors. CONCLUSIONS: Sulodexide proved to be an effective, safe, well-tolerated and pathogenetically substantiated pharmacological agent for treatment of patients presenting with lower-limb CVI and should therefore be recommended for patients at early stages of formation of CVD. Patients suffering from venous trophic ulcers require higher doses and prolonged administration of the drug.

[Multicentre observational study of Phlebodia 600 in treatment of patients with CEAP class C0-C3 chronic venous diseases]. / Mnogotsentrovoe nabliudatel'noe issledovanie primeneniia Flebodia 600 u bol'nykh c khronicheskimi zabolevaniiami ven klassov C0-C3 po CEAP.

The purpose of the study was to evaluate efficacy of Diosmin (Phlebodia 600, Innothera, France) in treatment of patients presenting with class C0s-C3 chronic venous diseases (CVD) according to the CEAP classification. Presented herein are the results of a prospective observational study aimed at assessing the outcomes of two-month administration of Phlebodia 600 (600 mg diosmin) in patients suffering from class C0s-C3 CVD according to the CEAP classification. The study comprised a total of 868 patients, including 175 (20.2%) men and 693 (79.8%) women. Of these, 866 patients completed the study according to the protocol. Amongst the 868 followed-up patients, 851 (98.0%) subjects strictly adhered to the physician's prescription and stopped taking the drug without violation of the regimen and dosing of diosmin. The main drug dosage regimen of diosmin was 1 tablet once a day in 851/868 (98.04%) patients. Satisfaction with treatment with diosmin was reported as 'excellent' by 46.7 % of patients (95% CI: 43.3-50.0) and by 49.4% of physicians (95%: CI 46.1-52.7), being rated as 'good' by 45.0% of patients (95 % CI: 41.7-48.4) patients and by 43.6% of physicians (95% CI: 40.3-47.0). The score for the quality of life of patients according to the CIVIQ-20 scale at the first follow-up visit amounted to 45.4±15.4 points (median 43.0 points). At the second follow-up visit, this parameter improved dramatically, dropping to the level of 35.6±11.5 points (median 33.0 points). By the third follow-up visit, the positive dynamics of the parameters preserved continued, averagely amounting to 28.9±8.7 points (median 26.0 points). A decrease in the circumference of the left and right crura (by 0.39±0.74 and by 0.36±0.75 cm, respectively) was observed at the second follow-up visit. The difference of the malleolar measurements between the first and third follow-up visits amounted to 7.2±9.4 mm and 6.6±9.7 mm for the right and left crus, respectively (p<0.001). The number of patients with a reported feeling of heaviness in the legs statistically significantly decreased from 97.6% at the stage of enrollment into the study to 73.0% after 2 months of therapy, that of those with painful sensations from 84.5 to 55.3%, those with complaints of swelling (oedemas) of the lower limbs from 83.9 to 56.8%, with complaints of convulsions from 71.2 to 35.7%, with complaints of sensation of tingling from 63.4 to 34.1%, respectively. Hence, a statistically significant improvement of the patients' condition was observed as early as 30 days after the beginning of treatment. By day 60, the positive effect of the carried out therapy continued to grow. Safety and good tolerance of the drug were noted, which was confirmed by low incidence of undesirable events and high adherence to treatment.

Day surgery versus Outpatient setting for endovenous laser ablation treatment. A prospective cohort study.

OBJECTIVES: The traditional surgical approach to the treatment of the superficial venous insufficiency requires at least 12 h of post-operative monitoring and this often means the necessity of an overnight hospitalization. The introduction of new, less invasive techniques (i.e endovenous laser ablation) reduces the hospitalization stay in a Day Surgery setting. However, the increasing skills of the operators and the patient's selection, allows to propose endovenous laser ablation in an Outpatient setting. The aim of this study is to evaluate the activity of a single high-volume center. METHOD: We enrolled 112 consecutive patients with great sapehous vein insufficiency and indication to endothermal laser ablation, 57 operations (51%) were performed in Day Surgery setting and 55 (49%) in Outpatient setting according to endovascular laser ablation's criteria. Past medical history, CEAP classification, VCSS score, type of symptoms and intervention's data were collected. Post-operative results (success and complications rates, patient's functional and aesthetic satisfaction) were evaluated at 7 and 30 days after intervention. A QoL questionnaire (CIVIQ) was submitted to the patients 30 days after surgery. RESULTS: We did not observe a statistically significant difference between the two groups concerning treatment results and complications onset. The QoL assessment did not differed significantly, except for over 65-year old patients undergoing outpatient treatment that showed a better QoL compared to those undergoing the same treatment in Day Surgery (p 0.05). CONCLUSIONS: The endothermal laser ablation technique allows a safe, comfortable and faster management of the venous disease in Outpatient setting. This would further reduce the costs of the treatment while preserving the functional and aesthetic results and the low complication rate of the Day Surgery setting.

[Efficacy of sulodexide in treatment of chronic venous insufficiency. Results of the ACCORD trial]. / Éffektivnost' sulodeksida pri lechenii khronicheskoi venoznoi nedostatochnosti. Rezul'taty issledovaniia ACCORD.

OBJECTIVE: The purpose of our study was to evaluate both clinical and laboratory efficacy of sulodexide given at a daily dose of 500 lipasemic units (LSU) in patients presenting with class C3-C4 chronic venous insufficiency (CVI) according to the CEAP classification. PATIENTS AND METHODS: The study included a total of 25 patients diagnosed with C3-C4 CVI and prescribed to receive sulodexide at a daily dose of 500 LSU for 90 days. Efficacy was comprehensively controlled by the following tools: the disease-specific Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ), visual-analogue methods of assessment separate symptoms; the Venous Clinical Severity Score (VCSS), as well as ultrasonographic determination of the thickness of subcutaneous fat and crural fascia. Amongst the key laboratory indices determined by means of the ELISA test were the levels of interleukin-1 alpha (IL-1α), interleukin-1 beta (IL-1ß), matrix metalloproteinases-2 and -9 (MMP-2, MMP-9), vascular endothelial growth factor A (VEGF-A), vasopressin and endothelin. RESULTS AND DISCUSSION: Of the initially enrolled 25 subjects, twenty-two patients completed the study and were taken as 100%. The 90-day treatment yielded favourable results manifesting themselves in complete disappearance of convulsions in the calf muscles detected at the first visit in 22.7% of patients (p=0.0485), a significant reduction in the frequency of complaints of decreased tolerance to static loads from 27.3 to 9.1% (p=0.2404). The volume of the crus of the control lower extremity decreased from 134.18±14. 92 to 128.42±12.46 cm3 (p=0.0006), subcutaneous fat thickness at the fixed point decreased from 1.50±0.53 to 1.32±0.46 cm (p=0.0007), and fascial thickness decreased from 0.14±0.7 to 0.11±0.04 (p=0.0359). Pain syndrome according to the visual analogue scale (VAS) decreased from 36.45±25.60 to 17.50±19.27 mm (p=0.0002). The global index of quality of life (GIQoL) according to the CIVIQ-20 increased by 27.7% compared with the baseline level (p = 0.0001), the VCSS index decreased from 6.00±1.83 to 4.86±2.05 points (p=0.0002). as for the laboratory markers of endothelial dysfunction, there was a significant decrease in the levels of MMP-2 - from 178.53±36.30 to 176.35±36.67 ng/ml (p=0.0152), MMP-9 - from 90.84±20.41 to 89.78±20.32 ng/ml (p=0.0394), and that of endothelin - from 0.42±0.10 to 0.39±0.10 fmol/ml. CONCLUSION: Sulodexide exerting a statistically significant clinical and endothelium-protecting effect turned out to be an effective drug for treatment of initial forms of chronic venous insufficiency of lower limbs.

Effect of socio-demographic characteristics and clinical findings on the quality of life of patients with chronic venous insufficiency.

Objective This study was planned and implemented to evaluate the effect of socio-demographic characteristics and clinical findings on the quality of life of patients with chronic venous insufficiency. Methods The sample of this cross-sectional study consisted of 163 patients that presented with the diagnosis of chronic venous insufficiency to the cardiovascular surgery clinic of an education and research hospital in the west of Turkey. The data were collected during face-to-face interviews using a personal information form, clinical, etiology, anatomy, pathophysiology classification, venous insufficiency epidemiological and economic study-quality of life/symptoms scales and the Short Form-36. Descriptive statistics as well as univariate and multivariate analyses were used to analyze the data. Results The chronic venous insufficiency patients were found to have a low quality of life. Advanced age, higher body mass index, longer working times, being on regular medication, hypertension and presence of pigmentation according to the clinical, etiology, anatomy, pathophysiology classification were found to be associated with a reduced physical score in SF-36. Furthermore, longer weekly working hours and presence of pigmentation reduced the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms scores. Undertaking physical exercise at twice and more than twice a week increased the overall physical scores in SF-36. Conclusions The results of the study showed that the quality of life of chronic venous insufficiency patients are affected by not only physical characteristics, working hours and physical activity but also presence of edema and pigmentation.

[Treatment of chronic venous diseases in children and adolescents].

Presented herein is experience in diagnosis and treatment of chronic diseases of lower-limb veins in a total of 242 children and adolescents. The authors used CEAP classification; C1 class was more often encountered in children. Treatment included surgical interventions, sclerotherapy, laser coagulation of pathological veins of lower extremities. Therapeutic outcomes were satisfactory in all patients, with no complications observed. It was determined that in paediatric phlebological practice prevailing are class C1 chronic venous diseases; characteristic is high concern of both the patient and parents. A timely commenced conservative program of treatment for children makes it possible to improve quality of life in class C1 and C2 chronic venous diseases. Laser coagulation of varicose saphenous veins of lower limbs in children makes it possible to remove pathological vessels, significantly improving quality of life of patients and shortening the terms of hospitalization twofold. Application of transcutaneous laser coagulation (Nd:YAG, 1064 nm) and microfoam sclerotherapy in children makes it possible to completely remove class C1 varicose veins, improving quality of life.

Psychometric Validation of the 14 items ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ-14): Confirmatory Factor Analysis.

OBJECTIVES: The study aim was to confirm the factorial structure of the short (14 item) version of the ChronIc Venous Insufficiency quality of life Questionnaire (CIVIQ-14) using the Vein Consult Program (VCP) results. METHODS: The international VCP study sought to evaluate the impact of chronic venous disease (CVD) on health care costs and quality of life (QoL). The factorial structure of the CIVIQ-14 was evaluated using two methods: exploratory factor analysis (EFA) to calculate the probabilities of items and dimensions remaining stable and to study the dimensionality of the scale using explained variance criteria, followed by confirmatory factor analysis (CFA) to confirm the original three dimensional structure and investigate alternative models that may have arisen from the dimensionality analysis. We also used the VCP results to evaluate the psychometric properties of the questionnaire and conducted subgroup analyses on countries with validated translations. RESULTS: A total of 47,149 questionnaires from 17 countries were available in the VCP. EFA revealed both items and dimensions as 100% stable. Dimensionality analysis showed that a two factor approach could be considered. CFA revealed the CIVIQ-14 three dimensional structure to be acceptable while rejecting the two dimensional model. Psychometric analysis confirmed the construct validity, internal consistency, and known groups validity of the CIVIQ-14. The results of subgroup analyses were consistent with those of the primary analysis. CONCLUSIONS: CFA of VCP data supported the factorial structure of the CIVIQ-14. The analysis corroborates the wide use of CIVIQ-14 as a valid instrument for reporting QoL in CVD patients.

Utility of iliac vein stenting in elderly population older than 80 years.

BACKGROUND: The geriatric population aged 80 years and older with severe manifestations of chronic venous disease face diminishing therapeutic options. Self-applied compression is often not possible because of frailty or arthritis. Significant limb swelling diminishes mobility, affects independent living, and precipitates institutionalization. Limb ulceration and pain diminish quality of life at a time when it is paramount. Cellulitis uniquely poses septicemic risk in this age group. Family caregivers are often able to continue home care if the intensity of care can be reduced. Iliac vein stenting may have a role as it appears to be safe and effective in this advanced stage of life. METHODS: Patients who had failed to respond to compression and desired palliation of continuing severe chronic venous disease symptoms were considered for iliac vein stenting. Intravascular ultrasound-guided stenting was carried out under fluoroscopy without venography in case of allergy to contrast material or decreased renal function. General anesthesia was used for better cardiopulmonary control. RESULTS: A total of 107 limbs (12 bilateral) were treated with iliac vein stents during a 13-year period, representing 5% of all stented limbs. Median age was 83 years (80-96 years), and 10 were ≥ 90 years; 59% were post-thrombotic. Clinical, etiologic, anatomic, and pathologic classification was as follows: C2 (with pain), 3%; C3, 32%; C4, 33%; C5, 5%; and C6, 27%. Concurrent saphenous ablation was carried out in 28% when saphenous reflux was considered ancillary and not the main disease. There was no mortality. Reintervention was required in 20% of limbs for nonocclusive stent malfunction; 2% of stents occluded. Primary and primary-assisted duplex patency rates at 5 years were 52% and 90%, respectively. The visual analog scale score of pain improved from median 4 (0-9) to 0 (0-10) after stenting (P < .0001). Pain was completely relieved in 43% of limbs. Cumulative improvement in the pain score of at least 3 points was 71% at 6 years. Swelling (grade 0, none; grade 1, pitting; grade 2, ankle edema; grade 3, gross) improved from median 3 (0-3) to 1 (0-3) (P < .0001). Swelling completely resolved in 25% of limbs. Cumulative improvement of at least one grade of swelling (examination) was 63% at 6 years; 70% of limbs (n = 33) with prior cellulitis were relieved of recurrence after stent placement; 61% of active ulcers healed, and 37% of patients were able to discard stockings (P < .001). CONCLUSIONS: Iliac vein stenting appears to offer a safe and effective option in octogenarians and nonagenarians when compression fails, is difficult, or is impossible.

Health-related quality-of-life scales specific for chronic venous disorders of the lower limbs.

OBJECTIVE: We conducted a systematic review of the literature about quality-of-life (QOL) scales in chronic venous disorders (CVDs) comprising leg ulcers to identify the respective advantages and deficits of existing tools. METHODS: A research protocol was built following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the PICO (population, intervention, comparator, and outcome) criteria. The following databases were screened: MEDLINE, SCOPUS, EMBASE, CINHAL, and Cochrane. Psychometric and linguistic validation studies in English were included, as were clinical trials that have used QOL scales in CVDs. The data search was up to date as of October 31, 2013. RESULTS: Inclusion criteria were met in 103 of the 511 recorded references, in which 10 scales were identified: two for the full spectrum of CVDs, three for patients with CVDs without leg ulceration, four for leg ulcers, and one exclusively for patients with varicose veins. Among them, the ChronIc Venous Insufficiency Questionnaire (CIVIQ), Aberdeen Varicose Vein Questionnaire (AVVQ), and VEnous INsufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) scales were the most highly used according to the literature, and CIVIQ and VEINES-QOL were the most extensively validated scales and had the longest iterative validation process. A total of 31 psychometric and linguistic validations of the 10 QOL scales and 66 clinical trials that have used these scales were identified. The validation studies were based on acceptability, content validity, construct validity, reliability, and responsiveness. The clinical trials were composed of 25 randomized controlled trials and 41 observational studies. Only the randomized controlled trials are considered in the present article. CONCLUSIONS: This systematic review confirmed that CVDs have an important effect on QOL. The majority of the studies addressed the application rather than the validation of the 10 identified scales. Two scales, CIVIQ and VEINES-QOL, emerged as being thoroughly validated instruments, although factorial stability was not demonstrated for the VEINES-QOL. Our findings confirm a paucity of validation studies.

The influence of the CIVIQ dimensions on quality of life of patients with primary superficial venous incompetence.

OBJECTIVES: To get to know the influence of the four domains of the Chronic Lower Limb Venous Insufficiency Questionnaire (CIVIQ) on the quality of life (QoL) of patients with primary superficial venous incompetence, and their behaviour in relation to age, gender, occupation, body mass index (BMI), and also with respect to the clinical and anatomical classes of the CEAP. MATERIAL AND METHODS: The sample was composed of 468 patients with primary superficial venous reflux (135 male and 333 female) who answered 100% of the questions in the Short Form-12 (SF12) and CIVIQ questionnaires. After a clinical and duplex examination, the patients were categorized as C0-6, Ep, As, Ap or As,p and Pr according to the CEAP classification. The relationships between CIVIQ domains and gender, age, occupation, BMI, and the clinical and anatomical classes of the CEAP classification were analyzed. RESULTS: Men reported better QoL than women (33.2 vs. 46.3) and this was also true for each of the CIVIQ's domains (p < .00). Pain (50.6) and physical restriction (45.3) were the dimensions with a greater influence on QoL, whereas social (41.7) and psychological (38.1) dimensions had a lesser influence. Patients aged between 45 and 64, household activities, and patients with C2-3 clinical classes were the patient groups with the worst scores in all the CIVIQ dimensions and those where significant differences were found. The BMI and anatomical distribution of the reflux had no influence on the QoL. CONCLUSIONS: Pain and physical restriction were the CIVIQ domains with greater influence on the QoL of patients with primary superficial venous reflux. Age increase (up to 64 years), female gender, household activities, and C2-3 CEAP clinical class were the main factors associated with the worst QoL perception.

Study to develop a waiting list prioritization score for varicose vein surgery.

BACKGROUND: The objective of this study was to develop a clear-cut, objective system for prioritization of patients on the waiting list for varicose vein surgery, to enable organization of access to the health service. METHODS: During earlier phases, we selected which variables should be taken into account for the prioritization scale, such as clinical presentation, varicose vein size, complications, work situation, and influence on quality of life. In the last phase, to determine the relative weight of each variable, structured surveys (personal interviews or by e-mail) were performed of the convenience samples from the groups related to the healthcare process, including patients, relatives, and healthcare professionals. RESULTS: The structured survey we utilized was administered to a sample of 762 subjects that included 290 patients, 99 relatives, 179 general practitioners, 32 nurses, and 162 vascular surgeons. The final score included clinical manifestations (46.1% of relative importance), size of the varicose veins (8.2%), complications (18.3%), influence on quality of life (18.2%), and aggravating work factors (9.2%). CONCLUSIONS: The prioritization system agreed upon by all the groups involved could allow for objective and transparent prioritization and lead to the rationalization of access to varicose vein surgery for patients on the waiting list.

Great saphenous vein ablation with steam injection: results of a multicentre study.

OBJECTIVE: To assess the safety and efficiency of steam vein sclerosis (SVS) of the great saphenous vein (GSV) in a multicentre open prospective cohort study. DESIGN: 75 consecutive adult patients with GSV reflux, CEAP C2-C5 and vein diameter 4-13 mm. METHODS: Patients treated using an SVS™ generator delivering homogenous pulses of superheated steam were followed up at 8 days and 1, 3, 6 and 12 months (clinical, duplex ultrasound, quality of life [QoL] with SF12). RESULTS: 88 veins were treated in 75 patients. At 6 months, 72/75 (96%) veins were obliterated (95% CI: 89-99) and Kaplan-Meier analysis found an obliteration rate of 96.1% at 12 months. QoL increased at 6 months for both the physical and mental components (p = 0.049 and p < 0.001 respectively). SVS was well tolerated: no major complications were reported. Adverse events occurred mainly at day 8 and incidents amounted to ecchymosis (n = 60) and pain (n = 7). CONCLUSIONS: SVS achieved an obliteration rate similar to that of other thermal ablation techniques. It was well tolerated with minimal post-operative pain.

Quality of life in chronic venous disease patients measured by short Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) in Serbia.

BACKGROUND: This was a psychometric validation of the short Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) as quality of life (QOL) instrument for chronic venous disease (CVD) patients. METHODS: Patients aged >18 years who had CVD in CEAP C stages C0s to C6 were included in the study. Diagnosis was made by general practitioners according to CVD symptoms and visual examination of the lower extremities. QOL was assessed with the self-administrated CIVIQ-14. The reliability, construct, and convergent validity of the CIVIQ-14 was estimated as well as QOL of CVD patients according to CEAP C stages. RESULTS: The study comprised 2260 subjects who fully completed the CIVIQ-14. CIVIQ-14 had a high level of reliability, construct, and convergent validity, but the structure of its three dimensions (pain [P], physical [PHY], and psychological [PSY]) was suboptimal. After adjustment for age, body mass index, and number of CVD symptoms, CIVIQ -14 global, P, PHY, and PSY scores showed significant progressive reduction of QOL from CEAP class C0s to C6. These differences were present in both sexes. The progressive impairment of the QOL involved primarily the pain and the physical items. For all CEAP C classes, the P and PHY scores were lower than the PSY scores. Global scores for men and women were: 76.7 and 73.9 for C0s; 75.5 and 70.6 for C1; 67.8 and 64.5 for C2; 68.3 and 61.6 for C3; 60.7 and 54.6 for C4; 49.5 and 50.2 for C5; and 41.3 and 46.7 for C6. CONCLUSIONS: CVD in the lower extremities has a substantial effect on both physical and psychologic aspects of QOL, the physical aspects of QOL (P and PHY items) being more important. CIVIQ-14 is valuable in assessing QOL in CVD patients. Further investigations are necessary to confirm the stability of its two dimensions.

Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins.

OBJECTIVE: Thermal ablative techniques of varicose veins carry a risk of heat-related complications, including postoperative pain. Mechanochemical endovenous ablation (MOCA) might avoid these complications and reduce postoperative pain because of the absence of thermal energy. This study evaluated postoperative pain and quality of life after radiofrequency ablation (RFA) and MOCA for great saphenous vein (GSV) incompetence. METHODS: Sixty-eight patients with unilateral GSV incompetence were treated with either RFA or MOCA in this prospective observational study. Patients monitored their pain for the first 14 postoperative days on a 100-mm visual analog scale (VAS). They also completed the general (RAND 36-Item Short-Form Health Survey) and disease-specific (Aberdeen Varicose Vein Questionnaire) quality of life questionnaires before and 6 weeks after treatment. RESULTS: Patients treated with MOCA reported significantly less postoperative pain than patients treated with RFA during the first 14 days after treatment (4.8 ± 9.7 mm vs 18.6 ± 17.0 mm; P < .001) (mean VAS over 14 days). The lower postoperative pain score was associated with a significantly earlier return to normal activities (1.2 ± 1.8 vs 2.4 ± 2.8 days; P = .02) and work resumption (3.3 ± 4.7 vs 5.6 ± 5.8 days, respectively; P = .02). At 6 weeks, patients in both groups perceived an improved change in health status and an improved disease-specific quality of life. CONCLUSIONS: MOCA is associated with significantly less postoperative pain, faster recovery, and earlier work resumption compared with RFA in the treatment of GSV incompetence. MOCA and RFA are both related to a rapid improvement in quality of life.

Chronic venous disease in Spain: doctor-patient correlation.

AIM: The present study aimed to demonstrate how the quality of life (QoL) perceived by patients with chronic venous disease (CVD) is correlated with the severity of their disease objectively assessed by primary care physician. MATERIAL AND METHODS: A total of 1560 patients with CVD were evaluated using four measurement instruments: CEAP clinical classification, Venous Clinical Severity Score (VCSS), SF-12 Health Survey and Chronic Lower Limb Venous Insufficiency Questionnaire (CIVIQ-20). Statistical correlations between these tools were analysed using Spearman's coefficient. RESULTS: Patients were distributed in C0, 58 (3.7%); C1, 243 (15.6%); C2, 328 (21.0%); C3, 357 (22.9%); C4, 368 (23.6%); C5, 136 (8.7%); and C6, 70 (4.5%). The VCSS score for the whole cohort was 0.89 ± 0.53. The correlation between CEAP and VCSS was moderately strong (r = 0.69). The overall QoL scores measured by SF and CIVIQ were 56.84 ± 19.63 and 65.11 ± 14.35, respectively. The correlation between the two QoL questionnaires was very strong (r = 0.81). The correlations of the SF and CIVIQ with the VCSS were moderately strong (r = -0.47 and -0.48). The correlations between QoL questionnaires and CEAP were moderate and lower than those with VSCC. CONCLUSIONS: While there is correlation between VCSS, CEAP, modified CIVIQ and venous ultrasound findings, subgroup analysis indicates that this correlation is driven by different components of VCSS compared with the other venous assessment tools. Patients' opinions about their disease are correlated with those assessed by primary care physicians.

Great saphenous vein diameter does not correlate with worsening quality of life scores in patients with great saphenous vein incompetence.

OBJECTIVE: Previous studies have correlated increasing great saphenous vein (GSV) diameter with increasing CEAP clinical classification. Some insurance carriers are currently using specific GSV diameters to determine coverage for treatment of axial venous insufficiency. The aim of this study was to investigate the correlation of patient quality of life (QOL) measures with GSV diameters in varicose vein patients with GSV reflux. METHODS: Data were collected from the records of 91 patients prospectively enrolled in two varicose vein trials. The patients had symptomatic varicose veins with saphenofemoral junction and proximal GSV reflux. Maximum GSV diameter was measured on duplex ultrasound imaging, with the patient standing, within 5 cm of the saphenofemoral junction. Chronic Venous Insufficiency Questionnaire 2 (CIVIQ-2; Servier, Neuilly-sur-Seine, France), Venous Insufficiency Epidemiological and Economic Study (VEINES) Symptom (Sym) and QOL assessments, and the Venous Clinical Severity Score (VCSS) assessment were completed before treatment of GSV insufficiency. Demographic information, patient weight, height, and body mass index were collected. Correlations between pairs of data were done using Pearson product-moment and Spearman correlation coefficients. RESULTS: The 91 study patients (19 men, 72 women) were a mean age of 45 years (range, 18-65 years). The mean GSV diameter was 6.7 mm (range, 2.2-14.1 mm). The mean VCSS score was 7.8 (range, 3-12). There was a weak correlation between increasing GSV diameter and VCSS (r=0.23; P=.03) and no correlation between GSV diameter and the CIVIQ-2 score (r=0.01), VEINES-QOL (r=-0.07), and VEINES-Sym (r=-0.1). CONCLUSIONS: GSV diameter is a poor surrogate marker for assessing the effect of varicose veins on a patient's QOL; thus, using GSV diameter as a sole criterion for determining medical necessity for the treatment of GSV reflux is inappropriate. Further correlations between QOL measures and duplex-derived objective findings are warranted.

Validity and reliability of VEINES-QOL/Sym questionnaire in chronic venous disorders.

AIM: The aim of this study was to translate the VEINES-QOL/Sym questionnaire into Turkish, which is used mainly in Western European countries, and to study its reliability and validity. METHODS: Standard "forward-backward" translation method was used to translate the questionnaire. The internal consistency was assessed with Cronbach's α, test-retest reliability was assessed with the intraclass correlation and Spearman-Brown coefficients. Validity was examined by correlation of VEINES-QOL/Sym with SF-36, Venous Clinical Severity (VCSS), and Venous Disability Scores (VDS). RESULTS: Out of 100 patients included (mean age 41.9 ± 12.5 years; 32% male, 68% female), 30 were given the questionnaire twice with 24-hour intervals for test-retest; a final completion rate of 99.2% was achieved. The Cronbach's α was 0.914. The Spearman-Brown coefficients and the intraclass correlation coefficients were 0.994, 0.988 and 0.966, 0.933 for VQOL and VSym scores, respectively. For the total quality of life and for several domains the correlations between VEINES-QOL/Sym and SF-36 were high, and significant. Inverse and significant correlations were observed with VCSS. CONCLUSION: Conclusively, the Turkish version of VEINSES-QOL/Sym questionnaire is reliable and valid; thus, it is highly recommended to use Turkish version of VEINSES-QOL/Sym to evaluate the quality of life and symptoms of patients with venous insufficiency in Turkey.

Modelling the effect of venous disease on quality of life.

BACKGROUND: A clear understanding of the relationship between venous reflux, clinical venous disease and the effects on quality of life (QoL) remains elusive. This study aimed to explore the impact of venous disease, and assess any incremental direct effect of progressive disease on health-related QoL, with the ultimate aim to model venous morbidity. METHODS: Consecutive patients with venous disease were assessed for inclusion in the study. Patients with isolated, unilateral, single superficial axial incompetence diagnosed on duplex imaging were included. Clinical grading was performed with the Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification and Venous Clinical Severity Score (VCSS). Patients completed generic (Short Form 36, SF-36(®); EuroQol 5D, EQ-5D(™)) and disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ) QoL instruments. Multivariable regression modelling was performed, taking account of demographic and anatomical factors, to explore the effect of clinical severity on QoL impairment. RESULTS: Some 456 patients with C2-6 venous disease were included, along with control data for 105 people with C0-1 disease. Increasing clinical grade corresponded strongly with deterioration in disease-specific QoL (P < 0.001). This could be stratified into three distinguishable groups: C0-1, C2-4 and C5-6 (P < 0.001 to P = 0.006). Increasing clinical grade also corresponded with deterioration in the physical domains of SF-36(®) (P < 0.001 to P = 0.016), along with EQ-5D(™) index utility (quality-adjusted life year) scores (P < 0.001). CONCLUSION: Demonstrable morbidity was seen, even with uncomplicated venous disease. The physical impairment seen with venous ulceration was comparable with that seen in congestive cardiac failure and chronic lung disease.