de Vries Marianne, Ouwendijk Rody, Kessels Alphons G, de Haan Michiel W, Flobbe Karin, Hunink Maria G M, van Engelshoven Jos M A, Nelemans Patricia J
Department of Radiology, Cardiovascular Research Institute Maastricht, Maastricht University Hospital, The Netherlands.
J Vasc Surg. 2005 Feb;41(2):261-8. doi: 10.1016/j.jvs.2004.11.022.
This study compared the ability of generic and disease-specific questionnaires to assess quality of life (QOL) at baseline and to detect change in QOL after treatment in patients with peripheral arterial disease (PAD).
This prospective multicenter trial recruited 514 patients with PAD who needed an imaging workup and had an ankle brachial pressure index of less than 0.90. Patients with severe comorbidity were excluded, leaving a study population of 450 patients. Patients completed two generic questionnaires, the Short Form 36 (SF-36) and the European Quality of Life 5D (EuroQol-5D), and one disease-specific questionnaire, the Vascular Quality of Life (VascuQol) at baseline and after 6 months of follow-up. Rutherford classification and treadmill walking distance were determined at baseline and after 6 months of follow-up and were considered indicators of disease severity. Receiver operating characteristic (ROC) curves and areas under the curves (AUCs) were used to evaluate each of the three questionnaires for its ability to discriminate between severe and mild disease at baseline and to discriminate between a large and small change in disease severity after follow-up. The underlying assumption was that disease severity is a major determinant of QOL. This implies that the validity of a QOL questionnaire is reflected by its ability to discriminate between mildly and severely diseased patients.
At baseline, 443 patients and after follow-up, 386 patients completed questionnaires. At baseline, no significant ( P >.05) differences were observed among AUCs for the total scores of the three questionnaires, indicating that all three questionnaires assessed the disease severity equally well. After follow-up, the AUCs for the VascuQol were significantly higher than the AUCs for the SF-36 and EuroQol-5D with respect to detection of improvement in Rutherford classification ( P < .05), indicating that change in disease severity after follow-up was best detected by the VascuQol.
The VascuQol is the preferred questionnaire as outcome measure for QOL in future trials and clinical follow-up of patients with PAD.
本研究比较了通用问卷和疾病特异性问卷在评估外周动脉疾病（PAD）患者基线生活质量（QOL）以及检测治疗后QOL变化方面的能力。
这项前瞻性多中心试验招募了514例需要进行影像学检查且踝肱压力指数小于0.90的PAD患者。排除严重合并症患者后，研究人群为450例患者。患者在基线和随访6个月后完成了两份通用问卷，即简明健康状况调查量表（SF - 36）和欧洲五维健康量表（EuroQol - 5D），以及一份疾病特异性问卷，即血管生活质量量表（VascuQol）。在基线和随访6个月后确定卢瑟福分类和跑步机行走距离，并将其视为疾病严重程度的指标。采用受试者工作特征（ROC）曲线和曲线下面积（AUC）来评估这三份问卷在基线时区分重度和轻度疾病以及随访后区分疾病严重程度的大变化和小变化的能力。基本假设是疾病严重程度是QOL的主要决定因素。这意味着QOL问卷的有效性通过其区分轻度和重度患病患者的能力来反映。
基线时，443例患者完成问卷，随访后，386例患者完成问卷。基线时，三份问卷总分的AUC之间未观察到显著差异（P>.05），表明这三份问卷在评估疾病严重程度方面同样良好。随访后，就检测卢瑟福分类的改善而言，VascuQol的AUC显著高于SF - 36和EuroQol - 5D的AUC（P<.05），表明随访后疾病严重程度的变化最好通过VascuQol检测。
在未来PAD患者试验和临床随访中，VascuQol是作为QOL结局指标的首选问卷。
