AI Article Synopsis

  • - The study investigates the Sleep-Loss Scale, a tool designed to assess how itch from atopic dermatitis (AD) affects sleep, highlighting its importance in AD treatment.
  • - Through interviews with 21 participants and data from clinical trials, the study evaluates the scale's content validity and measurement properties, demonstrating its reliability and effectiveness in detecting changes in sleep quality.
  • - Results confirm the Sleep-Loss Scale as a valid and reliable measure of sleep disruption due to itch, suggesting it is suitable for clinical trials aimed at improving treatment outcomes for individuals with moderate-to-severe AD.

Article Abstract

Background: Sleep loss is a key factor contributing to disease burden in people with atopic dermatitis (AD). Mitigating itch to improve sleep is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Sleep-Loss Scale, a single-item rating scale for assessing itch interference with sleep in clinical trials of AD treatments.

Methods: Concept elicitation and cognitive debriefing interviews were conducted with 21 adults and adolescents (12-17 years of age) with moderate-to-severe AD to develop a conceptual model of patient experience in AD and explore the content validity of the scale. Data collected from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess Sleep-Loss Scale's psychometric performance, including reliability, construct validity, and ability to detect change. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods.

Results: Qualitative findings from concept elicitation highlighted the importance of sleep-loss related to itch in AD. Debriefing analysis of the Sleep-Loss Scale indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported good reliability, construct validity and ability to detect improvement. MWPC was defined as a 1-point improvement using trial data, a finding supported by qualitative data.

Conclusions: The Sleep-Loss Scale provides a valid and reliable patient-reported measure of the impact of itch on sleep in patients with AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in moderate-to-severe patients.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263400PMC
http://dx.doi.org/10.1186/s41687-024-00764-2DOI Listing

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