Sleep-Loss Related to Itch in Atopic Dermatitis: Assessing Content Validity and Psychometric Properties of a Patient-Reported Sleep-Loss Rating Scale
Abstract
Background: Sleep loss is a significant issue for people with atopic dermatitis (AD) due to itch. Addressing itch to improve sleep is a crucial aspect of AD treatment.
Methods: Interviews were conducted with 21 adults and adolescents with moderate-to-severe AD to develop a conceptual model of patient experience and evaluate the Sleep-Loss Scale. Data from a phase 2b study (NCT03443024) were used to assess the scale’s performance.
Results: The study highlighted the importance of sleep loss related to itch in AD. Analysis of the Sleep-Loss Scale indicated its relevance and interpretive accuracy. Trial data supported good reliability, construct validity, and ability to detect improvement. A meaningful within-patient change threshold of a 1-point improvement was identified.
Conclusions: The Sleep-Loss Scale is a valid and reliable measure of the impact of itch on sleep in patients with AD, suitable for evaluating the efficacy of treatments in moderate-to-severe patients.
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