Psychometric validation and responder definition of the sleep disturbance numerical rating scale in moderate‐to‐severe atopic dermatitis. (17th November 2021)

• Record Type: Journal Article
• Authors: Puelles, J.; Fofana, F.; Rodriguez, D.; Silverberg, J.I.; Wollenberg, A.; Dias Barbosa, C.; Vernon, M.; Chavda, R.; Gabriel, S.; Piketty, C.
• Is Part Of: British journal of dermatology. Volume 186:Number 2(2022)
• Page Start: 285
• Page End: 294
• Publication Date: 2021-11-17
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.20783
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Sleep disturbance (SD) is an important part of the burden of atopic dermatitis (AD), but patient‐reported outcomes that are easy to understand and interpret in the target population have been lacking. A daily, single‐item, self‐reported SD 11‐point numerical rating scale (NRS) was recently developed to assess SD for patients with moderate‐to‐severe AD, but its psychometric properties have not yet been described. Objectives: To assess the psychometric properties of the SD NRS in patients with moderate‐to‐severe AD. Methods: The psychometric properties of the SD NRS were assessed using data from a phase IIb clinical trial in 218 adults with moderate‐to‐severe AD. Results: Test–retest reliability of the SD NRS was substantial to almost perfect (interclass correlation 0·66–1·00) in participants who had stable SD or stable pruritus scores over 1 week. Baseline correlations were moderate to large ( r > 0·30) between SD NRS and pruritus or sleep loss scores, but were small ( r = −0·11 to 0·17) between SD NRS and EQ‐5D‐3L index and visual analogue scores, Hospital Anxiety and Depression Scale, Scoring Atopic Dermatitis, and Investigator's Global Assessment. The SD NRS could discriminate groups of participants in the expected direction according to different quality‐of‐life scores but not according to different clinician‐reported disease severity scores. SD NRS scores significantly decreased as sleep loss, itch and quality‐of‐life scores improved. Analysis of meaningful change suggested a 2–5‐point improvement as the initial range of responder definition in the SD NRS score. Conclusions: The SD NRS is a reliable, valid and responsive measure of SD in adults with moderate‐to‐severe AD. Abstract : What is already known about this topic? Sleep disturbance (SD) is a dynamic, multidimensional concept resulting in daytime fatigue and subsequent changes in physical and mental health that vary from day to day. SD is an important part of the burden of atopic dermatitis, but ways of effectively and reliably measuring it from the patient perspective have been lacking. A self‐reported, daily, 11‐point SD numerical rating scale (NRS) was recently developed for assessing SD in patients with moderate‐to‐severe atopic dermatitis, and its content validity was previously established. What does this study add? The study showed that the SD NRS is reliable, valid and responsive and can measure day‐to‐day fluctuations in SD related to atopic dermatitis. The study also established an initial responder definition (i.e. meaningful interpatient change) for the SD NRS score. What are the clinical implications of this work? The SD NRS is a brief, simple, easy‐to‐interpret and validated patient‐reported global measure for the daily assessment of SD related to atopic dermatitis. The SD NRS can be used in clinical trials and clinical practice to assess changes in sleep quality in patients with atopic dermatitis. Plain language summary available online