# Validity, Reliability and Responsiveness of Wound‐QoL‐14 Quality of Life Questionnaire in Patients With Diabetes Related Foot Ulcers

## TL;DR

The Wound-QoL-14 questionnaire is a valid and reliable tool for measuring quality of life in people with diabetes-related foot ulcers, but it is not responsive to changes in ulcer severity.

## Contribution

The study validates Wound-QoL-14 for diabetes-related foot ulcers and highlights its responsiveness to healing status but not severity changes.

## Key findings

- Wound-QoL-14 showed convergent validity with DFS-SF but not in the burden/bothered domain.
- Wound-QoL-14 was responsive to healing status but not to changes in DFU severity.
- EQ-5D-5L is recommended for measuring generic quality of life in DFU patients.

## Abstract

Diabetes related foot ulcers (DFU) are associated with significant physical, psychological and social dysfunction. Measuring the impact of treatments on patients' overall well‐being is vital to ensure care is holistic. This study aimed to validate the Wound‐Qol‐14 quality of life assessment tool in people with a DFU. A single centre longitudinal prospective validation study in people with DFUs was conducted. Wound‐Qol‐14, Diabetic Foot Ulcer Scale—Short Form (DFS‐SF) and EuroQol 5 dimensions 5 levels (EQ‐5D‐5L) were completed by people with DFUs at baseline and 6 months. Wound‐Qol‐14 was repeated within 7 days of the first questionnaire. Correlation coefficients with a cut off of ≥ 0.7 were used to assess convergent validity, divergent validity and responsiveness to changes in DFU severity. Reliability was assessed using Cronbach's α. The study aimed to recruit 100 people. One hundred and seven people were recruited. The mean age was 62 (SD 13) years and 85 (79.4%) were male. The mean DFU duration was 30 (SD 83) days and the mean DFU area was 6.2 (SD 10.7) cm2. Convergent validity was demonstrated in all domains of Wound‐Qol‐14 and DFS‐SF (r − 0.695 to −0.799) except burden/bothered about ulcer care domains (r = −0.443). There was moderate correlation between Wound‐Qol‐14 domains and EQ‐5D‐5L dimensions (r = 0.477–0.501). Cronbach's α ranged from 0.683 to 0.919 for the domains of Wound‐Qol‐14. Wound‐Qol‐14 was not responsive to changes in DFU severity (r = −0.291; 95% CI −0.501 to −0.048) but was responsive to healing status (healed 1.14 [IQR 0.86] vs. unhealed 1.86 [IQR 1.47]; p = 0.017). Wound‐Qol‐14 is a valid and reliable tool to measure disease‐specific quality of life in people with DFUs. Further work is needed to refine the responsiveness. EQ‐5D‐5L should be used to measure generic quality of life in people with DFUs.

Wound‐Qol‐14 is valid and reliable tool to measure disease specific quality of life in people living with diabetes related foot ulcers.Wound‐Qol‐14 is responsive to healing status but not changes in SINBAD scores in people living with diabetes related foot ulcers.EuroQol 5 Dimensions 5 Levels (EQ‐5D‐5L) should be used to measure generic quality of life in people living with diabetes related foot ulcers.

Wound‐Qol‐14 is valid and reliable tool to measure disease specific quality of life in people living with diabetes related foot ulcers.

Wound‐Qol‐14 is responsive to healing status but not changes in SINBAD scores in people living with diabetes related foot ulcers.

EuroQol 5 Dimensions 5 Levels (EQ‐5D‐5L) should be used to measure generic quality of life in people living with diabetes related foot ulcers.