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 (p < 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) (p < 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.
Keywords: diabetic foot ulcer; psychometric validation; quality of life; reliability; type 2 diabetes; validity.