Development and preliminary validation of the Diabetes Hand Function Assessment.

BACKGROUND: Diabetic peripheral neuropathy is a common complication of type 2 diabetes mellitus that significantly impairs hand function. However, no patient-reported outcome measure currently exists to specifically assess hand function impairments in this population. PURPOSE: To develop and conduct preliminary validation of the Diabetes Hand Function Assessment (DHFA), a disease-specific patient-reported outcome measure designed to evaluate functional and symptom-related hand impairments in individuals with diabetic peripheral neuropathy. STUDY DESIGN: Cross-sectional clinical measurement. METHODS: The DHFA was developed in three phases: item generation through literature review and expert focus group (phase 1); content and face validity assessment by 10 experts and 10 individuals with diabetic peripheral neuropathy (phase 2); and preliminary psychometric testing on 150 individuals with diabetic peripheral neuropathy (phase 3). Internal consistency was evaluated using Cronbach's alpha. Convergent validity was assessed by correlating DHFA scores with the Malay Duruöz Hand Index (DHI). Known-groups validity was tested by comparing DHFA scores based on diabetes duration (<5 years vs ≥5 years). RESULTS: Content and face validity indices exceeded recommended thresholds (S-CVI/Ave = 0.90; S-FVI/Ave = 0.98). Internal consistency was excellent for the total DHFA (α = 0.972), section 1 (α = 0.967), and good for section 2 (α = 0.827). Convergent validity was supported by a strong negative correlation with the Malay-DHI (r = -0.940, p < 0.001). Known-groups validity showed significantly poorer hand function in participants with ≥5 years of diabetes (U = 676.5, Z = -7.977, p < 0.001), supporting the DHFA's ability to distinguish between severity groups. CONCLUSIONS: The DHFA is a promising patient-reported outcome measure, with future studies needed to establish test-retest reliability, responsiveness, and other psychometric properties. Its disease-specific focus and preliminary psychometric strength support its potential use in clinical assessment, rehabilitation planning, and research.