Quality of Life in Chronic Venous Disease: Bridging the Gap Between Patients and Physicians.

Chronic venous disease (CVD) has a negative impact on patients' quality of life (QoL). This was demonstrated in the recent Patient Journey on CVD study, which examined QoL in patients with early- and advanced-stage CVD (Clinical, Etiological, Anatomical and Pathophysiological classification C0 to C4), and the gaps between the way in which physicians and patients viewed the impact of CVD on QoL. The study was conducted in five countries (Brazil, China, Czech Republic, Italy and Russia) and included 100 patients with CVD and 60 CVD specialists. Patients completed the 14-item Chronic Venous Insufficiency Questionnaire (CIVIQ-14) to assess their QoL, and all patients and physicians were questioned during a 60-minute qualitative structured interview, focusing on four key dimensions-physical symptoms, aesthetics/appearance, emotional impact and impact on relationships. The study found that physicians tended to focus more on physical symptoms than on other impacts of CVD and rarely measured QoL in clinical practice. Patients were significantly less satisfied with the management of their QoL than physicians perceived them to be. About 25% of patients with CVD reported disturbed sleep, but physicians did not routinely ask them how CVD affected their sleep. These data reinforce the importance of physicians obtaining information about the impact of CVD on all aspects of the patient's life, including sleep and QoL. Evidence from randomised controlled trials and real-world studies demonstrates that some veno-active drugs, particularly micronised purified flavonoid fraction, can positively impact QoL in patients with CVD.

A narrative review of the quality of life scales specific for chronic venous diseases.

ABSTRACT: To review the various quality of life (QoL) scales specific for chronic venous diseases (CVDs) and provide guidance and a reference for researchers to select the ideal measurement scale before studying QoL in patients with CVDs.The EBSCO, Ovid, PubMed, Wanfang, and CNKI databases were searched for the keywords "vein," "quality of life," and "scale/questionnaire," and various scales used to measure QoL in patients with CVDs. The QoL aspects were investigated and researched, and then, the search results were screened and summarized.A total of 10 major scales related to the QoL in patients with CVDs were included. The scales differed in dimension, reliability, validity, scoring method, evaluation method, and scope of application.The investigator should select the chronic venous disease QoL scale according to the research purpose and subjects, and then implement the scale to compare the specific aspects of QoL in patients with different CVDs.

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.

[Chronic leg ulcers in older patients]. / Ulcus cruris beim alten Patienten.

Chronic ulcers of the lower extremities are one of the most common medical problems encountered in western societies. The prevalence of leg ulcers is estimated to be 0.5-1.0% of the German population and is clearly associated with age. Therefore, in an aging society chronic leg ulcers are an important health issue with respect to increased morbidity and healthcare costs. The most frequent causes of leg ulcers are chronic venous insufficiency, peripheral arterial occlusive disease and diabetes mellitus. Efficient treatment necessitates an exact diagnosis and a close interdisciplinary collaboration. Affected patients often require instructions regarding self-help and support for competent nursing and prophylaxis. Therapeutic strategies, especially in the geriatric setting, aim to maintain the quality of life through preservation of patient mobility and autonomy.

Burden and Suffering in Chronic Venous Disease.

Chronic venous disease (CVD) is widespread, underdiagnosed, and can progress to chronic venous insufficiency and venous ulcers, which can require extensive treatment and hospitalization. These conditions negatively impact patient quality of life and place substantial burdens on healthcare resources. The two main risk factors for CVD are age and obesity. Thus, with the growing prevalence of obesity and the increasing longevity of the population, the burden of CVD is expected to increase dramatically in the coming decades. Appropriate lifestyle changes and care, which may include treatment with venoactive drugs, can slow disease progression, improve quality of life, and are likely to reduce healthcare costs. Physicians should be aware of this growing problem and of the effective treatments available for CVD. We recommend the accompanying short summaries from a symposium held at the recent European Venous Forum as a means for our colleagues to learn more about the burden and suffering associated with CVD.Funding: Servier.

Design and evaluation of the psychometric properties of a self-questionnaire on patient adherence to wearing elastic compression stockings.

BACKGROUND: Patients' adherence to elastic compression stockings is difficult to evaluate, and therefore we create a short self-questionnaire and validate its psychometric properties. METHODS: We reduce the questions with Varimed rotation analysis, evaluate its internal consistency using Cronbach's alpha test and its external validity by comparison to electronic thermic captors. Receiver operating characteristic (ROC) analysis was used to determine a threshold and determine its sensitivity and specificity. RESULTS: The initial questionnaire was reduced from 22 to 5 questions rated from 0 to 4. The internal consistency and its external validity are good, and the ROC analysis shows that values > 3 correspond to poor compliance with a sensitivity of 88.1% and a specificity of 63.1%. CONCLUSION: The adherence score is valid for the detection of patients poorly compliant to the wearing of elastic compression. Its small number of questions makes it a suitable for a screening in everyday practice.

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.

Efficacy of micronized purified flavonoid fraction (Daflon®) on improving individual symptoms, signs and quality of life in patients with chronic venous disease: a systematic review and meta-analysis of randomized double-blind placebo-controlled trials.

INTRODUCTION: The use of a venoactive drug is considered an important component of medical treatment of chronic venous disease (CVD), although the efficacy of certain venoactive drugs (VADs) on one or more individual leg symptoms or signs may have not been extensively studied to justify a strong recommendation in guidelines on CVD. The aim of this systematic review and meta-analysis was to study the effectiveness of the micronized purified flavonoid fraction (MPFF, Daflon®) across the spectrum of defined venous symptoms, signs, quality of life (QoL) and treatment assessment by the physician. EVIDENCE ACQUISITION: On September 9, 2017, a systematic review of the databases MEDLINE, Scopus and Cochrane Central was performed, supplemented by hand searching, to identify randomized double-blind placebo-controlled trials on MPFF in patients with CVD. EVIDENCE SYNTHESIS: The main outcome measures were the individual and global symptoms, leg edema and redness, skin changes, QoL and evaluation of the overall effectiveness of the treatment by the physician. The effectiveness of MPFF compared with placebo was expressed as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI). Trial quality of evidence was graded using the GRADE system. RESULTS: We identified 7 trials, mostly with low risk of bias, involving 1,692 patients. On qualitative analysis, MPFF significantly improved nine defined leg symptoms, including pain, heaviness, feeling of swelling, cramps, paresthesia, burning sensation, and pruritus (itching), but also functional discomfort compared with placebo, leg redness, skin changes and QoL. On quantitative analysis, MPFF compared with placebo, assessed as a categorical variable, reduced leg pain (RR 0.53, P=0.0001, NNT=4.2), heaviness (RR 0.35, P<0.00001, NNT=2.0), feeling of swelling (RR 0.39, P<0.00001, NNT=3.1), cramps (RR 0.51, P=0.02, NNT=4.8), paresthesia (RR 0.45, P=0.03, NNT=3.5), and functional discomfort (RR 0.41, P=0.0004, NNT=3.0). Similarly, MPFF compared with placebo, assessed as a continuous variable reduced pain (SMD -0.25, 95% CI -0.38 to -0.11), heaviness (SMD -0.80, 95% CI -1.05 to -0.54), feeling of swelling (SMD -0.99, 95% CI -1.25 to -0.73), burning sensation (SMD -0.46, 95% CI -0.78 to -0.14), cramps (SMD -0.46, 95% CI -0.78 to -0.14), and functional discomfort (SMD -0.87, 95% CI -1.13 to -0.61). Regarding objective assessments of leg edema, the use of MPFF compared with placebo reduced ankle circumference (SMD -0.59, 95% CI -1.15 to -0.02), and leg redness (SMD -0.32, 95% CI -0.56 to -0.07, RR 0.50, P=0.03, NNT=3.6), improved skin changes (RR 0.18, P=0.0003, NNT=1.6) and quality of life (SMD -0.21, 95% CI -0.37 to -0.04) and was associated with clinical improvement as assessed by the physician (RR 0.28, P<0.00001, NNT=2.5). Heterogeneity was mostly minimal. The existing evidence where sufficient was mostly of high quality. CONCLUSIONS: Based on high quality evidence, MPFF is highly effective in improving leg symptoms, edema and quality of life in patients with CVD.

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.

Cultural adaptation and validation of the Swedish VEINES-QOL/Sym in patients with venous insufficiency.

Objectives To translate and evaluate the psychometric properties of the Venous Insufficiency Epidemiological and Economic Studies (VEINES) questionnaire, divided into two subscales; symptoms (VEINES-Sym) and quality of life (VEINES-QOL), in a Swedish cohort of patients with venous disease. Methods The original questionnaire was translated into Swedish with forward-backward translation and administered to 112 patients who were consecutively recruited and had varying degrees of chronic venous disease. Mean age was 54.5 ± 15.2 years (range: 19-83) and 75% of the participants were female. All patients completed the RAND 36-item health survey and the VEINES-QOL/Sym. Results The results showed excellent internal consistency for both VEINES-QOL (Cronbach's alpha (α) = 0.93) and VEINES-Sym (α = 0.89). Both the VEINES-QOL and VEINES-Sym correlated well to all the RAND-36 domains, demonstrating good construct validity. Exploratory factor analysis confirmed both subscales of the VEINES-QOL/Sym. Conclusions The Swedish VEINES-QOL/Sym is a valid health-related quality of life instrument for chronic venous disease, both for research purposes and for clinical evaluation.

[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.

Validation of the Croatian version of CIVIQ quality of life questionnaire in patients with chronic venous disorders.

AIM: To test the psychometric properties of the Croatian version of the Chronic Venous Insufficiency Quality of Life (CIVIQ) Questionnaire and to assess the quality of life in patients with chronic venous disorders of all stages. METHODS: This cross-sectional study performed between 2014 and 2015 in a private family practice assessed the factorial validity, cross-sectional validity, and reliability of the Croatian CIVIQ 20-item questionnaire completed by 428 adult patients (78% women) with chronic venous disorders classified according to the Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) C classification as stages C1-C6. RESULTS: Median patient age was 52 years (5th-95th percentile, 30-77). The distribution according to the clinical stages of chronic venous disorders was as follows: C1 (n=78, 18%), C2 (n=192, 45%), C3 (n=53, 12%), C4 (n=44, 10%), C5 (n=13, 3%), and C6 (n=48, 11%). The CIVIQ-20 factorial structure was unstable, and six items were excluded from the analysis to test the psychometric properties of the shortened version (CIVIQ-14). CIVIQ-14 has three dimensions (physical, psychological, and pain). Internal consistency reliability is high for the entire CIVIQ-14 (Cronbach α=0.92) and for all CIVIQ-14 dimensions (α≥0.80). The median quality of life significantly decreased with higher CEAP C stages as follows: C1/C2 (86, 50-100); C3/C4 (75, 36-98); C5/C6 (67, 31-95) (P<0.001). Post-hoc analysis showed a higher quality of life in C1/C2 than in other groups (P<0.001). CONCLUSION: The shortened CIVIQ-14 version is useful for assessing the quality of life in patients with chronic venous disorders in everyday clinical practice. To achieve a stable validated instrument, we recommend a cross-cultural validation of items that have loadings on more than one factor.

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.

Sulodexide in Patients with Chronic Venous Disease of the Lower Limbs: Clinical Efficacy and Impact on Quality of Life.

INTRODUCTION: Chronic venous disease (CVD) of the lower limbs is a common problem. It is more prevalent in women than in men and has a significant impact on patients' quality of life (QoL) and on the healthcare system. The aim of this study was to evaluate the efficacy of sulodexide in adult patients with CVD of the lower limbs and its effect on patients' QoL. METHODS: Patients with CVD were treated with sulodexide [250 LSU (lipasemic units) twice daily] for 3 months in a setting of real-life clinical practice. The endpoints of this observational non-comparative, open-label prospective study were the clinical efficacy of sulodexide (evaluated by scoring objective and subjective symptoms with a Likert-type scale) and the impact of sulodexide therapy on patients' QoL [assessed using the chronic venous insufficiency quality of life questionnaire (CIVIQ)]. RESULTS: The study included 450 patients (mean age 46.9 ± 10.5 years, range 17-78 years). A greater percentage of patients were female (65.4%). Three months of treatment with sulodexide significantly improved all objective and subjective symptoms (p < 0.0001). Overall, patients reported a significant improvement in all QoL scores (p < 0.0001). Adverse events were spontaneously reported by two patients (one case of epigastric pain and one of gastric pain with vomiting). CONCLUSION: Oral sulodexide significantly improves both objective and subjective symptoms, as well as functional and psychological aspects of QoL in patients with CVD. FUNDING: No funding or sponsorship was received for this study. Sponsorship for article processing charges and open access fees was provided by Alfa Wassermann.

[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.

Quality of life in patients with chronic venous disease in Turkey: influence of different treatment modalities at 6-month follow-up.

PURPOSE: The main purpose of this study was to evaluate the influence of any of the four domains of the QoL score in CVD patients of classes C0-C4 and to analyze the correlation between the QoL and types of treatment modalities, and an additional aim of the present study was to compare QoL levels of patients with CVD and healthy participants and was to examine the factors associated with QoL in CVD patients. METHODS: The sample was composed of 501 patients with primary superficial venous reflux (28.5 % male and 71.5 % female) who answered 100 % of the questions in the World Health Organization Quality of Life (WHOQoL-BREF) questionnaire. After a clinical and duplex examination, the patients were categorized as C0-C4, according to the CEAP classification. The relationships between WHOQoL-BREF domains and gender, age, occupation, BMI, the clinical classes of the CEAP classification and four different treatment modalities according to guideline were analyzed. RESULTS: For the WHOQOL-BREF test battery, the patients with CVD had worse values, as compared with the control group participants. The differences were significant for the physical (77.81 ± 12.75 vs. 59.18 ± 12.90, p < 0.001), the psychological (74.78 ± 11.37 vs. 60.21 ± 14.70, p < 0.001), the social relationships (76.56 ± 13.56 vs. 63.07 ± 21.37, p < 0.001) and the environmental (70.27 ± 13.36 vs. 50.16 ± 11.39, p < 0.001) health scores. The patients with CVD had worse WHOQOL-BREF scores at initial, compared with the 6-month follow-up scores. CONCLUSION: This study shows that in spite of undergoing therapy, the subsequent QoL scores did not improve significantly, indicating that CVD continued to negatively affect the patient's life.