Martinez-Gonzalez Dolores, Dòria Montse, Martínez-Alonso Montserrat, Alcubierre Nuria, Valls Joan, Verdú-Soriano José, Granado-Casas Minerva, Mauricio Didac
Lleida Institute for Biomedical Research Dr. Pifarré Foundation IRBLleida, University of Lleida, Rovira Roure, 80, 25198 Lleida, Spain.
Department of Endocrinology and Nutrition, Health Sciences Research Institute and University Hospital Germans Trias i Pujol, Camí de les Escoles S/N, 08916 Badalona, Spain.
J Clin Med. 2020 Aug 3;9(8):2497. doi: 10.3390/jcm9082497.
Diabetic foot ulcer (DFU) is a chronic complication that negatively affects the quality of life (QoL) of diabetic patients. In Spain, there is no specifically designed and validated instrument to assess the QoL of patients with DFU. Our aim was to adapt the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) questionnaire to a Spanish population and validate it. A prospective, observational design was used. The DFS-SF was administered by personal interview. The validated SF-36 and EQ-5D generic instruments were used as reference tools. The reliability, validity, and sensitivity to changes were assessed using standard statistical methods. A sample of 141 patients with DFU was recruited. The content validity was 3.46 on average (maximum score of 4). The internal consistency of the DFS-SF subscales showed a standardized Cronbach's α range between 0.720 and 0.948. The DFS-SF domains showed excellent reproducibility measures (intraclass correlation coefficient from 0.77-0.92). The criterion validity was good with significant correlations between each DFS-SF subscale and its corresponding SF-36 and EQ-5D subscales ( < 0.001). However, the questionnaire structure was not validated (comparative fit index = 0.844, root mean square error of approximation = 0.095, and standardized root mean square residual = 0.093). The instrument showed high sensitivity to ulcer changes over time ( < 0.001). The adapted and validated Spanish version of the DFS-SF questionnaire has good psychometric properties and shows good sensitivity to ulcer changes, although the construct validity was not optimal. The adapted questionnaire will be a useful tool specifically to assess the QoL in subjects with diabetic foot ulcers in the clinical and research settings in Spain.
糖尿病足溃疡（DFU）是一种慢性并发症，会对糖尿病患者的生活质量（QoL）产生负面影响。在西班牙，尚无专门设计并经过验证的工具来评估DFU患者的生活质量。我们的目标是将糖尿病足溃疡量表简表（DFS-SF）问卷改编为适用于西班牙人群的版本并进行验证。采用前瞻性观察设计。通过个人访谈来发放DFS-SF问卷。使用经过验证的SF-36和EQ-5D通用工具作为参考工具。采用标准统计方法评估其信度、效度和对变化的敏感性。招募了141例DFU患者作为样本。内容效度平均为3.46（满分4分）。DFS-SF各子量表的内部一致性显示，标准化的Cronbach's α范围在0.720至0.948之间。DFS-SF各领域显示出极好的重测信度指标（组内相关系数为0.77 - 0.92）。效标效度良好，DFS-SF各子量表与其相应的SF-36和EQ-5D子量表之间存在显著相关性（<0.001）。然而，问卷结构未得到验证（比较拟合指数 = 0.844，近似均方根误差 = 0.095，标准化均方根残差 = 0.093）。该工具对溃疡随时间的变化显示出高敏感性（<0.001）。改编并经验证的西班牙文版DFS-SF问卷具有良好的心理测量特性，对溃疡变化显示出良好的敏感性，尽管结构效度并非最佳。改编后的问卷将成为西班牙临床和研究环境中专门评估糖尿病足溃疡患者生活质量的有用工具。
