Hard to heal (HTH) wounds often result in a prolonged and painful healing process that affects different dimensions of patients' quality of life. Currently, there is no Danish patient-reported instrument to help professionals and patients identify and measure these different aspects of quality of life. Wound-quality of life (Wound-QoL) is a German 17-item questionnaire measuring dimensions of wound-specific quality of life. The aim was to translate and cross-culturally adapt the Wound-QoL into Danish and to evaluate its psychometric properties. Translation was conducted in accordance with international guidelines. Validity, reliability and responsiveness were evaluated in accordance with the COSMIN guideline. The Wound-QoL was successfully translated to Danish and content validity showed to be very good in a Danish context. A total of 172 patients with HTH wounds were included in the study and all participants completed the Wound-QoL. Out of these, respectively 54 and 155 patients were included in the analyses of test-retest reliability and responsiveness. Correlations for construct validity (EQ-5D-5L vs. Wound-QoL) ranged between 0.64 and 0.73. Cronbach's alpha values for internal consistency ranged between 0.77 and 0.92. Intra-class-correlation coefficients for test-rest reliability ranged between 0.73 and 0.88. Smallest detectable change scores at individual and group level ranged from 0.77 to 1.26 and 0.10 to 0.17, respectively. Minimal important change scores ranged from 1.20 to 1.33. Results of the responsiveness analyses showed sensitivity and specificity values between 56.1 to 62.2 and 57.7 to 63.2, respectively. In conclusion, the Danish Wound-QoL is a valid and reliable patient-reported outcome measure for assessing aspects of health-related quality of life in patients with hard ho heal wounds. However, the Wound-QoL demonstrated limited ability to discriminate between patients with clinically relevant improvements and patients that showed no changes. Thus, the responsiveness of the Wound-QoL should be taken into consideration if to be used as treatment effect measure.
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