Validation of the Lymphoedema Quality-of-Life Questionnaire (LYMQOL) in Dutch Patients Diagnosed with Lymphoedema of the Lower Limbs.

BACKGROUND: The Lymphoedema Quality-of-Life Questionnaire is a validated disease-specific instrument to measure the impact of lymphoedema on patients' lives. In this study, we tested its psychometric properties and validated the use of the questionnaire in its Dutch translation. METHODS: We obtained the answers to a standardised questionnaire, including Lymphoedema Quality-of-Life Questionnaire and Short-Form (36) Health Survey, twice at an interval of 2 weeks in 60 patients with lower limb lymphoedema. Feasibility was tested on the basis of missing responses and response distribution. Structure was studied using factor analysis. The reliability of the Lymphoedema Quality-of-Life Questionnaire was assessed using Crohnbach's α and test-retest reliability. Construct validity was tested by correlating Lymphoedema Quality-of-Life Questionnaire scores with the Short-Form (36) Health Survey scores. RESULTS: The response rate was 88.2%. One of the 22 items missed >10% of responses; another showed a borderline ceiling effect. Internal consistency was good and test-retest reliability was excellent. The Lymphoedema Quality-of-Life Questionnaire correlated well with the physical component of the Short-Form (36) Health Survey and moderately with the mental component, suggesting that its construct validity was good. CONCLUSION: The Dutch Lymphoedema Quality-of-Life Questionnaire can be used for health-related quality-of-life research in lower limb lymphoedema patients.

Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins.

BACKGROUND: A variety of techniques exist for the treatment of patients with great saphenous vein (GSV) varicosities. Few data exist on the long-term outcomes of these interventions. METHODS: Patients undergoing conventional surgery, endovenous laser ablation (EVLA) and ultrasound-guided foam sclerotherapy (UGFS) for GSV varicose veins were followed up for 5 years. Primary outcome was obliteration or absence of the treated GSV segment; secondary outcomes were absence of GSV reflux, and change in Chronic Venous Insufficiency quality-of-life Questionnaire (CIVIQ) and EuroQol - 5D (EQ-5D™) scores. RESULTS: A total of 224 legs were included (69 conventional surgery, 78 EVLA, 77 UGFS), 193 (86.2 per cent) of which were evaluated at final follow-up. At 5 years, Kaplan-Meier estimates of obliteration or absence of the GSV were 85 (95 per cent c.i. 75 to 92), 77 (66 to 86) and 23 (14 to 33) per cent in the conventional surgery, EVLA and UGFS groups respectively. Absence of above-knee GSV reflux was found in 85 (73 to 92), 82 (72 to 90) and 41 (30 to 53) per cent respectively. CIVIQ scores deteriorated over time in patients in the UGFS group (0.98 increase per year, 95 per cent c.i. 0.16 to 1.79), and were significantly worse than those in the EVLA group (-0.44 decrease per year, 95 per cent c.i. -1.22 to 0.35) (P = 0.013). CIVIQ scores for the conventional surgery group did not differ from those in the EVLA and UGFS groups (0.44 increase per year, 95 per cent c.i. -0.41 to 1.29). EQ-5D™ scores improved equally in all groups. CONCLUSION: EVLA and conventional surgery were more effective than UGFS in obliterating the GSV 5 years after intervention. UGFS was associated with substantial rates of GSV reflux and inferior CIVIQ scores compared with EVLA and conventional surgery. REGISTRATION NUMBER: NCT00529672 (http://www.clinicaltrials.gov).

Translation and validation of the Dutch VEINES-QOL/Sym in varicose vein patients.

OBJECTIVES: To translate from English to Dutch and evaluate the psychometric properties of the VEnous INsufficiency Epidemiological and Economic Studies (VEINES) questionnaire, divided in symptom (VEINES-Sym) and quality of life (VEINES-QOL) subscales. METHODS: Standard forward-backward translation method was used to translate the 26 items of the VEINES-QOL/Sym. Eligible patients had to complete a standardized questionnaire. Demographic, venous disease characteristics, clinical venous signs, CEAP (clinical, aetiological, anatomical and pathological elements) classification and ultrasound findings were also noted. If item's scores were in an extreme category in more than 70% of patients a floor or ceiling effect was present. Feasibility of the individual items was considered poor if 5% or more of the responses were missing. The validity was tested by comparing the VEINES-QOL/Sym scores to the Short Form 36 (SF-36) scores and across the different 'CEAP' categories. Confirmatory factor analysis was used to assess the underlying structure of the VEINES-QOL/Sym. RESULTS: Sixty-six patients were included (response rate of 72%). None of the 26 items missed <10% of responses, but two showed ceiling effect. Both the VEINES-QOL and VEINES-Sym showed an excellent internal consistency (Cronbach's alpha of 0.88 and 0.81, respectively). The VEINES-QOL demonstrated a good construct validity for the physical component of the SF-36, but not for the mental component (rho = 0.62 and 0.22, respectively), as expected. The VEINES-Sym correlated poorly to both SF-36's components. According to the confirmatory principle axis factoring, only three out of 25 items did not load sufficiently on the factor. CONCLUSIONS: The Dutch VEINES-QOL/Sym can be used for health-related quality of life research in varicose veins patients and the evaluation of therapies.

Validation of the chronic venous insufficiency quality of life questionnaire in Dutch patients treated for varicose veins.

BACKGROUND: The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) is a disease-specific instrument to measure the impact of chronic venous insufficiency (CVI) on patients' lives. The objective of this study is to test the psychometric properties of the CIVIQ, and to validate the use of the questionnaire translated into the Dutch language. METHODS: A standardised questionnaire, including CIVIQ and Short Form (36) Health Survey (SF-36), was obtained before and 1 month after treatment to all new patients with varicose veins. The feasibility was tested by missing responses and response distribution. CIVIQ scores were compared to the SF-36 scores and between different levels of severity of varicose veins. The CIVIQ's reliability was assessed using Cronbach's alpha and test-retest reliability. The structure was studied using factor analysis. The scores before and after therapy were compared to assess responsiveness. RESULTS: There was a response rate of 93.5%. None of 20 items missed < 10% of responses, but three showed ceiling effect. The CIVIQ correlated well with the physical and moderately with the mental MCS of the SF-36, suggesting a good construct validity of the CIVIQ. The median CIVIQ scores increased significantly with the severity of varicose veins. The CIVIQ showed an excellent internal consistency and an excellent test-retest reliability. The CIVIQ score decreased in 76% of patients after treatment. The results were in accordance with the Norman's rule and showed a median effect size. CONCLUSION: This study confirms the feasibility, validity, reliability and responsiveness of the CIVIQ in patients with varicose veins. The psychometric properties of the Dutch CIVIQ were comparable to the original French version.

Endovenous therapies of varicose veins: indications, procedures, efficacy and safety.

Venous insufficiency of the lower-extremity is common and the prevalence increases with age. Chronic venous insufficiency has a high impact on patients' health related quality of life (HRQOL) and is associated with considerable health care costs. In addition to classical symptoms, it may result in skin changes and venous ulcers. Since more than hundred years, surgical ligation of the junction with or without stripping has been the standard of care in the treatment of insufficient great and small saphenous veins. However, the recurrence rates are relatively high and surgery may be associated with serious adverse events, considerable down time and is cosmetically suboptimal. In the last decade several minimally invasive techniques have been introduced, to improve efficacy, patients' HRQOL and treatment satisfaction, and to reduce serious side effects, costs and postoperative pain. Dermatologists have played an important role in the development of minimal invasive therapies Ultrasound guided foam sclerotherapy, endovenous laser therapy and radiofrequency ablation are the most commonly used therapies, and challenge surgery as the gold standard of care in patients with varicose veins. The objective of this review is to inform clinicians about these three therapeutic options for saphenous varicose veins and to describe and compare the indications, procedures, efficacy and safety profile.