Granado-Casas Minerva, Martinez-Gonzalez Dolores, Martínez-Alonso Montserrat, Dòria Montserrat, Alcubierre Nuria, Valls Joan, Julve Josep, Verdú-Soriano José, Mauricio Didac
Lleida Institute for Biomedical Research Dr. Pifarré Foundation IRBLleida, University of Lleida, Av. Alcalde Rovira Roure 80, 25198 Lleida, Spain.
Department of Endocrinology & Nutrition, Hospital de la Santa Creu i Sant Pau, Sant Quintí 89, 08041 Barcelona, Spain.
J Clin Med. 2021 Sep 6;10(17):4023. doi: 10.3390/jcm10174023.
Diabetic foot ulcers (DFU) negatively affect the quality of life (QoL) of people with diabetes. The Cardiff Wound Impact Schedule (CWIS) questionnaire has been designed to measure the QoL of people with chronic foot wounds. However, no studies have been specifically designed to validate this instrument in a Spanish population. In this prospective study, a total of 141 subjects with DFU were recruited. DFU was determined by performing physical examinations. Medical records were exhaustively reviewed to collect clinical variables. The CWIS was transculturally adapted by a group of experts and a group of patients with DFU. The SF-36 and EQ-5D generic instruments were used as reference tools. The questionnaires were administered at 7 days and 4, 12, and 26 weeks after the baseline assessment by personal interview with each of the study subjects. The psychometric properties of the instrument were assessed using statistical methods. The content validity had an average of 3.63 (90.7% of the maximum score of 4). The internal consistency of the CWIS subscales had a standardized Cronbach's alpha range from 0.715 to 0.797. The reproducibility was moderate with an intraclass correlation coefficient (ICC) range from 0.606 to 0.868. Significant correlations between CWIS domains and SF-36 and EQ-5D subscales were observed, demonstrating a good criterion validity of the CWIS questionnaire ( < 0.001). However, the construct validity of the CWIS was not validated with a comparative fit index (CFI) of 0.69, a root mean square error of approximation (RMSEA) of 0.09, and a standardized root mean square residual (SRMR) of 0.10. The sensitivity to changes over time was optimal in the three domains (i.e., social life, well-being, and physical symptoms) ( < 0.001). In conclusion, the Spanish version of the CWIS shows acceptable psychometric properties to assess the QoL of subjects with DFU, except for its construct validity.
糖尿病足溃疡（DFU）对糖尿病患者的生活质量（QoL）产生负面影响。卡迪夫伤口影响量表（CWIS）问卷旨在测量慢性足部伤口患者的生活质量。然而，尚未有专门针对西班牙人群验证该工具的研究。在这项前瞻性研究中，共招募了141名DFU患者。通过体格检查确定DFU。详尽查阅病历以收集临床变量。一组专家和一组DFU患者对CWIS进行了跨文化改编。使用SF - 36和EQ - 5D通用工具作为参考工具。通过对每位研究对象进行个人访谈，在基线评估后的7天以及4周、12周和26周发放问卷。使用统计方法评估该工具的心理测量特性。内容效度平均为3.63（满分为4分，占最高分的90.7%）。CWIS分量表的内部一致性具有标准化的克朗巴哈系数，范围从0.715至0.797。重测信度中等，组内相关系数（ICC）范围从0.606至0.868。观察到CWIS各领域与SF - 36和EQ - 5D分量表之间存在显著相关性，表明CWIS问卷具有良好的效标效度（<0.001）。然而，CWIS的结构效度未得到验证，比较拟合指数（CFI）为0.69，近似均方根误差（RMSEA）为0.09，标准化均方根残差（SRMR）为0.10。在三个领域（即社交生活、幸福感和身体症状）中，对随时间变化的敏感性最佳（<0.001）。总之，除结构效度外，CWIS的西班牙语版本在评估DFU患者生活质量方面显示出可接受的心理测量特性。
