Launois R, Reboul-Marty J, Henry B
Département de Santé Publique, Faculté de Médecine Léonard De Vinci, Université de Paris, France.
Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228.
Quality of life may be considerably reduced in patients who are suffering from chronic lower limb venous insufficiency, although existing generic quality of life instruments (NHP, SF-36 or SIP) cannot completely identify their specific complaints. The Chronic Venous Insufficiency Questionnaire (CIVIQ) has been developed by iterative process. First, a pilot group of 20 patients was used to identify a number of important features of quality of life affected by venous insufficiency, other than physical symptoms of discomfort. A second study involving 2,001 subjects was used to reduce the number of items. Subjects were asked to score both the severity of their problems and the importance they attributed to each problem on a 5-point Likert scale. The importance items found in patients with venous insufficiency were subjected to factorial analyses (PCA, PAF). The final version is a 20-item self-administered questionnaire which explores four dimensions: psychological, physical and social functioning and pain. Internal consistency of the questionnaire was validated for each dimension (Cronbach's alpha > 0.820 for three out of four factors). Reproducibility was confirmed in a 60 patient test-retest study. Pearson's correlation coefficients for both the four dimension subscales and for the global score at 2-week intervals were greater than 0.940. Finally, the questionnaire was tested in a randomized clinical trial of 934 patients in order to assess responsiveness and the convergent validity of the instrument, together with the patient's own quality of life. This study demonstrated that convergence was valid: Pearson's correlation coefficients between clinical score differences and quality of life score differences were small (from 0.199-0.564) but were statistically different from 0 (p < 0.001). Standardized response mean (SRM) and effect size (ES) were calculated to assess sensitivity to change. SRM and ES both demonstrated considerable responsiveness to change (> 0.80). Reliability, face, content, construct validity and responsiveness were also determined for this specific quality of life questionnaire relating to venous insufficiency. Results suggest that this questionnaire may be used with confidence to assess quality of life in clinical trials on chronic venous insufficiency.
慢性下肢静脉功能不全患者的生活质量可能会大幅下降，尽管现有的通用生活质量评估工具（NHP、SF - 36或SIP）无法完全识别他们的具体不适。慢性静脉功能不全问卷（CIVIQ）是通过反复研究过程开发出来的。首先，选取20名患者组成一个试验组，以确定除身体不适症状外，受静脉功能不全影响的生活质量的一些重要特征。第二项研究涉及2001名受试者，用于减少问卷项目数量。受试者被要求根据5级李克特量表对自身问题的严重程度以及他们认为每个问题的重要性进行评分。对静脉功能不全患者中发现的重要项目进行因子分析（主成分分析、主因子分析）。最终版本是一份包含20个条目的自填式问卷，探讨四个维度：心理、身体和社会功能以及疼痛。对问卷每个维度的内部一致性进行了验证（四个因子中有三个因子的Cronbach's alpha > 0.820）。在一项针对60名患者的重测研究中证实了问卷的可重复性。四个维度子量表以及两周间隔的总体得分的皮尔逊相关系数均大于0.940。最后，在一项对934名患者的随机临床试验中对该问卷进行了测试，以评估其反应性、工具的收敛效度以及患者自身的生活质量。这项研究表明收敛效度是有效的：临床评分差异与生活质量评分差异之间的皮尔逊相关系数较小（从0.199至0.564），但与0有统计学差异（p < 0.001）。计算标准化反应均值（SRM）和效应量（ES）以评估对变化的敏感性。SRM和ES均显示出对变化有相当大的反应性（> 0.80）。还确定了这份与静脉功能不全相关的特定生活质量问卷的信度、表面效度、内容效度、结构效度和反应性。结果表明，该问卷可放心用于慢性静脉功能不全临床试验中的生活质量评估。
