Children with atopic dermatitis (AD) commonly have sleep difficulties and disturbance that could negatively impact their physical development. An 11-point caregiver-reported sleep quality numeric rating scale (NRS; from 0 [worst possible sleep] to 10 [best possible sleep] over past 24 hrs) to assess sleep quality in children aged 6 mo. to <6 yrs with moderate to severe AD was developed and evaluated. Caregivers (n=15) participating in qualitative interviews found the sleep quality NRS to be important and relevant to the impact of AD on their child’s sleep, and the response scale clear and easy to use. Psychometric properties of the instrument were evaluated using data from a Phase 3 study of dupilumab in children aged 6 mo. to <6 yrs with moderate to severe AD (NCT03346434). The test-retest reliability intraclass correlation coefficient (95% CI) was 0.80 (0.69, 0.87), above the recommended 0.70 threshold. The sleep quality NRS was shown to discriminate well between patients grouped into bands according to the Caregiver Global Impression of Disease (CGID), Infants’ Dermatitis Quality of Life Index (IDQOL), Children’s Dermatology Life Quality Index (CDLQI) and Patient-Oriented Eczema Measure (POEM) (P < 0.0001). Evidence of responsiveness was demonstrated by the moderate correlations of change (|r| ≥ 0.30) observed with many of the supportive measures, and significant difference across subgroups categorized as improved, unchanged, or worsened on CGID (P = 0.0037). These results indicate that the caregiver-reported sleep quality NRS is a valid, reliable, and responsive instrument to assess sleep quality in children aged 6 mo. to <6 yrs with moderate to severe AD.
