Clinimetric Evaluation of the Vascular Quality of Life Questionnaire in Patients with Lower Limb Ischaemia.

OBJECTIVES: Although commonly used to measure health related quality of life in patients with lower limb ischaemia, the measurement properties of the VascuQol and its assumed underlying health dimensions have not been studied in depth. The objective of this study was therefore to evaluate aspects of reliability and validity of the Dutch version of the VascuQol in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). METHODS: Two datasets containing 195 patients with IC and 150 patients with CLI were used. Face validity of the VascuQol was examined in interviews with patients and a survey among health professionals. Homogeneity and structural validity of the VascuQol were assessed using Cronbach's α coefficients and explanatory factor analysis. Furthermore, convergent validity and known group validity were assessed. RESULTS: During the face validity interviews, three items were indicated as less relevant. Homogeneity analysis showed that the α coefficient of the VascuQol was .93, while the symptoms and social domains had α coefficients below the threshold of .70. The original five domains of the VascuQol could not be reproduced. Instead, factor analysis yielded a three factor solution. Moderate correlations were found for the activities, social and emotional VascuQol domains and matching health domains of other patient reported outcome measures (PROMs). Lower convergent correlations were observed for the pain domain and the sumscore of the VascuQol. The VascuQol was able to distinguish between patients' level of HRQL in relation to their disease severity (IC versus CLI patients). CONCLUSIONS: There is room for improvement of the VascuQol questionnaire. Further clinimetric studies should be performed to strengthen clinically relevant findings based on this instrument.

Determining the Minimally Important Difference for the VascuQol Sumscore and Its Domains in Patients with Intermittent Claudication.

OBJECTIVES: The VascuQol is a questionnaire for health related quality of life (HRQL) in patients with intermittent claudication (IC), and is frequently used to evaluate treatment effects. Yet, the interpretation of change in score on a questionnaire is not always obvious. The minimally important difference (MID) represents the smallest change in score on a questionnaire that is considered relevant by patients. This study aims to determine the MID for the VascuQol sumscore and its different domains for patients with IC. METHODS: A total of 118 participants were recruited from the SUPER study, a multicenter randomized controlled trial comparing angioplasty with supervised exercise therapy for alleviation of IC due to an iliac artery stenosis or occlusion. All patients completed the VascuQol and the Short Form 36 (SF-36) questionnaires at baseline and after 12 months of follow up. Two anchor based methods for MID calculation were applied. Two anchors were used: six global rating of change questions aimed at the VascuQol sumscore and subscales and the health transition item of the SF-36, both recorded at 12 months of follow up. RESULTS: The MID for the VascuQol sumscore ranged between 1.19 and 1.66 for improvement and 0.08 and 0.41 for deterioration. For the pain domain, MID values ranged from 1.48 to 1.91 for improvement and 0.19 to 0.34 for deterioration. Finally, for the activities domain MID values ranging from 1.55 to 2.2 and from 0.12 to 0.26 for improvement and deterioration were found, respectively. Since the correlations between the anchors and the symptom, social and emotional subscales were below the threshold of 0.3, the MID was not calculated for these subscales. CONCLUSIONS: The range of MID values found in this study is an indication of the smallest change score on the VascuQol questionnaire score that is considered relevant by patients with IC. They may help to better interpret trial results and set treatment goals.

Test-retest Reliability and Measurement Error Are Excellent for the Dutch Version of the VascuQol Questionnaire in Patients with Intermittent Claudication.

OBJECTIVES: Although the Vascular Quality of Life Questionnaire (VascuQol) is a widely used instrument to assess quality of life in patients with peripheral arterial disease (PAD), data on its reliability are scarce and its measurement error is unknown. The aim of this study was to determine test-retest reliability and measurement error of the Dutch version of the VascuQol in patients with intermittent claudication (IC). METHODS: Patients with intermittent claudication due to PAD presenting between October 2013 and April 2014 completed the VascuQol twice, with a 1 week interval. Test-retest reliability was expressed as the intraclass correlation coefficient (ICC) with 95% confidence interval (CI), and measurement error as a standard error of measurement (SEM). RESULTS: Sixty-one patients completed two VascuQol questionnaires sufficiently. The ICC for the VascuQol sumscore was 0.91 (95% CI 0.86-0.95). The ICC for the different VascuQol domains ranged between 0.77 (95% CI 0.64-0.86) and 0.87 (95% CI 0.79-0.92). The SEM of the sumscore was 0.34 and ranged between 0.44 and 0.76 for the different VascuQol domains. CONCLUSIONS: The test-retest reliability of the Dutch version of the VascuQol is excellent, both for the sumscore and for its different domains. The VascuQol has a measurement error that is sufficiently small to allow detection of clinically relevant changes.

Assessing the quality of available patient reported outcome measures for intermittent claudication: a systematic review using the COSMIN checklist.

OBJECTIVE: The aim was to critically appraise, compare, and summarize the quality of the measurement properties of all available disease specific patient reported outcome measures (PROMs) on health related quality of life and functional status validated in patients with intermittent claudication (IC). METHODS: A systematic search was carried out in Embase and Medline (last search November 18, 2013). The quality of the identified studies was assessed per measurement property according to the COnsensus-based Standards for the selection of health Measurements Instruments (COSMIN) checklist. Data on the measurement properties were extracted to determine a level of evidence per measurement property per instrument. RESULTS: Forty three studies were found evaluating 10 health related quality of life and two functional status PROMs. Evidence for the existence of subscales (structural validity) and for internal consistency (interrelatedness of items within subscales) for PROMs was generally poor. Evidence for construct validity was limited. Accuracy and reproducibility of PROMs were often uncertain, since reliability studies were mostly performed in small patient samples. Responsiveness, or the ability of PROMs to detect change over time, was hardly ever studied. CONCLUSION: The quality of the validation of most disease specific PROMs for IC is alarming, hampering all conclusion based on these PROMs. Considering the results, the PAD quality of life questionnaire (PADQOL), Intermittent claudication questionnaire (ICQ) and the Vascular quality of life questionnaire (VascuQol) might be appropriate PROMs for health related quality of life, while the Walking impairment questionnaire (WIQ) and Estimate ambulation capacity by history questionnaire (EACH-Q) appear suitable PROMs for functional status. However, all PROMs require further validation studies to fill the gaps in their measurement properties. The shortcomings highlighted in this review should be taken into account when interpreting PROM results.

Editor's Choice - Endovascular aneurysm repair versus open repair for patients with a ruptured abdominal aortic aneurysm: a systematic review and meta-analysis of short-term survival.

BACKGROUND: There is clinical equipoise between open (OR) and endovascular aneurysm repair (EVAR) for the best treatment of ruptured abdominal aortic aneurysm (RAAA). OBJECTIVE: The aim of the study was to perform a systematic review and meta-analysis to estimate the short-term (combined 30-day or in-hospital) survival after EVAR and OR for patients with RAAA. Data sources included Medline, Embase, and the World Health Organization International Clinical Trials Registry until 13 January 2014. All randomised controlled trials (RCTs), observational cohort studies, and administrative registries comparing OR and EVAR of at least 50 patients were included. Articles were full-length and in English. METHODS: Standard PRISMA guidelines were followed. The methodological quality of RCTs was assessed with the Cochrane Collaboration's tool for assessing risk of bias. The quality of observational studies was assessed with a modified Cochrane Collaboration's tool for assessing risk of bias, the Newcastle-Ottawa Scale, and the Methodological Index for Non-Randomized Studies. The results of the RCTs, of the obersvational studies, and of the administrative registries were pooled separately and analysed with the use of a random effects model. RESULTS: From a total of 3,769 articles, three RCTs, 21 observational studies, and eight administrative registries met the inclusion criteria. In the RCTs, the risk of bias was lowest and the pooled odds ratio for death after EVAR versus OR was 0.90 (95% CI 0.65-1.24). The majority of the observational studies had a high risk of bias and the pooled odds ratio for death was 0.44 (95% CI 0.37-0.53). The majority of the administrative registries had a high risk of bias and the pooled odds ratio for death was 0.54 (95% CI 0.47-0.62). CONCLUSION: Endovascular aneurysm repair is not inferior to open repair in patients with a ruptured abdominal aortic aneurysm. This supports the use of EVAR in suitable patients and OR as a reasonable alternative.

Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 2: Below the knee).

OBJECTIVE: To evaluate 1 to 48 month follow-up outcomes of different endovascular treatment strategies in below-the-knee (BTK) arterial segments in critical limb ischemia (CLI) patients. METHODS: Medline and Embase were searched (last searched on 5 November 2013) for studies of randomized controlled trials comparing either balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another. Methodological quality of each trial was assessed using a Cochrane Collaboration's tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were wound healing, quality of life, change in Rutherford classification, amputation, death, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, and event-free survival with follow-up periods of at least 1 month. RESULTS: Twelve trials including 1145 patients were identified, with 90% of patients having CLI. Six BS versus PTA and two DES versus PTA trials showed low-quality evidence of equal efficacy. One trial, comparing DEB with PTA, showed moderate-quality evidence of improved wound healing (RR 1.28; 95% CI: 1.05 to 1.56; p=.01), improvement in Rutherford classification (RR 1.32; 95% CI: 1.08 to 1.60; p=.008), and lower TLR (RR 0.41; 95% CI 0.23 to 0.74; p=.002) and binary restenosis (RR 0.36; 95% CI 0.24 to 0.54; p<.0001) in diabetic patients after 12 months. Amputation and death rate did not differ significantly. For DES versus BS, most trials showed equal efficacy between strategies. CONCLUSION: Based on low- to moderate-quality evidence, PTA with optional bailout stenting using BS should remain the preferred strategy in treating CLI patients with BTK arterial lesions. Before other strategies can be implemented, larger and high-quality RCTs assessing clinically relevant outcomes are needed.

Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 1: Above the knee).

OBJECTIVE: To evaluate 1 to 36 month follow-up outcomes of different endovascular treatment strategies in above-the-knee (ATK) arterial segments in patients with intermittent claudication (IC) and critical limb ischemia (CLI). METHODS: Studies indexed in Medline and Embase from 1980 to November 2013 of randomized controlled trials comparing balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another were included. Methodological quality of each trial was assessed using the Cochrane Collaboration tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were quality of life, walking capacity evaluated by treadmill or questionnaire, change in Rutherford classification, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, amputation, death, major adverse cardiac events, or event-free survival with follow-up periods of at least 1 month. RESULTS: Twenty-three trials including 3314 patients in total were identified. Eighty-five per cent patients had IC and 15% CLI. Fifteen trials showed no systematic benefit of BS over PTA. One trial comparing DES and PTA reported no significant differences in walking capacity or Rutherford classification. Four trials showed a beneficial effect on TLR rate, but not on Rutherford classification of DEB compared with PTA. In four trials DES did not systematically perform better than BS. CONCLUSION: In general, performing PTA with optional bailout stenting for ATK lesions is the preferred strategy in patients with IC. For CLI, more studies are needed for recommending an optimal treatment strategy.