Cross-cultural Adaptation and Validation of the VascuQol-6 Spanish Version
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Reliability
研究概览
简要总结
VascuQol (VQ) is a specific questionnaire to assess the quality of life of patients with critical limb ischemia which is also used as an index in vascular registries. The original version has 25 items (VQ-25), divided into 5 subscales or domains: pain, symptoms, activity, social and emotional. The shortened version, VascuQol-6 (VQ-6) is made up of 6 questions and 4 possible answers, which score from 1 (worst quality of life perceived by the patient) to 4 (best quality of life perceived by the patient). The total score is between 6 and 24, and a higher value is related to better health.
While the VQ-25 questionnaire has been translated and validated in 21 languages, the shortened version VQ-6 has been translated and validated in some languages, not including Spanish. As it is a fast and easy-to-use tool iwhich has demonstrated statistical validation to measure PAD in other versions of the same questionnaire (other languages), a cross-cultural adaptation and statistical validation of the questionnaire from English to Spanish will be carried out.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •With a diagnosis of Peripheral Arterial Disease (intermittent claudication and critical lower limb ischemia)
- •Whose first language is Spanish
- •Who sign the informed consent.
排除标准
- •Patients with cognitive impairment that difficults understanding of the questionnaire
结局指标
主要结局
Reliability
时间窗: 3 -4 weeks from basal
Reliability refers to the degree to which an instrument is capable of measuring without errors. It measures the proportion or variation in the measurements that is due to the diversity of values adopted by the variable and not to the possible systematic or random error. Reliability will be assessed trough Cronbach's alpha coefficient measured for every item of the questionnaire.
Reproducibility
时间窗: 3-4 weeks from basal
Reproducibility of intra-observer reliabilty refers to the repeatibility of the instrument, when it is administered with the same method to the same population at two times. Kappa Index will be measured
Validity
时间窗: 3-4 weeks from basal
Validity is the ability of the questionnaire to measure the construct for which it has been designed. Pearson correlation between the domains of the questionnaire and ABI from each patient will be measured
次要结局
未报告次要终点