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A Brief Patient-Reported Symptom Burden Scale for Diabetic Foot Ulcer: Development and Validation
Kai Li1,2, Wenhui Dong1, Min Huang1,2
1Nanfang Hospital, Southern Medical University, Guangzhou, China.
International Wound Journal
|July 20, 2026
Summary
A new patient-reported scale effectively measures symptom burden in diabetic foot ulcers (DFU). This validated 23-item tool aids in systematic monitoring and symptom-focused care for DFU patients.
Area of Science:
- Medical Research
- Psychometrics
- Patient-Reported Outcomes
Background:
- Diabetic foot ulcers (DFU) cause significant morbidity, with symptom burden often underestimated by traditional wound-centered documentation.
- Existing assessments may not fully capture the multifaceted symptom experience of DFU patients.
Purpose of the Study:
- To develop and psychometrically evaluate a brief, DFU-specific patient-reported symptom burden scale.
- To create a tool for systematic symptom monitoring and to guide symptom-focused DFU care.
Main Methods:
- A two-phase study involving literature review, interviews, Delphi consultation, pilot testing, and a cross-sectional validation study in China.
- Item analysis, exploratory and confirmatory factor analysis, construct validity testing, and reliability assessment were performed on development (n=160) and validation (n=200) samples.
Main Results:
- A 23-item scale across six domains was finalized, assessing symptom frequency, severity, and distress.
- The scale demonstrated a robust six-factor structure explaining 64.398% of variance with acceptable model fit.
- High content validity (S-CVI/Ave=0.990), moderate correlation with DFS-SF scores (r=0.630), and satisfactory reliability (Cronbach's α=0.840, ICC=0.983) were confirmed.
Conclusions:
- The developed DFU symptom burden scale is a psychometrically sound instrument.
- This scale can facilitate comprehensive symptom assessment and personalized care strategies for diabetic foot ulcer patients.
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