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. 2025 Apr;15(4):963-995.
doi: 10.1007/s13555-025-01385-3. Epub 2025 Mar 21.

Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis

Jonathan I Silverberg  1 , Danielle N Rodriguez  2 , Carla Dias-Barbosa  3 , Dina Filipenko  4 , Liliana Ulianov  5 , Christophe Piketty  5 , Jorge Puelles  5
Affiliations

Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis

Jonathan I Silverberg et al. Dermatol Ther (Heidelb). 2025 Apr.

Abstract

Introduction: A subject sleep diary (SSD) capturing 14 sleep parameters was developed to assess daily fluctuations in atopic dermatitis (AD)-associated sleep disturbance. This study aimed to evaluate the psychometric properties of the SSD using data including all randomized patients from the phase 3 ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials of nemolizumab in adults and adolescents (age ≥ 12 years) with moderate-to-severe AD.

Methods: Reliability, validity, and responsiveness of the SSD were evaluated, and its relationship with the single-item Sleep Disturbance Numerical Rating Scale (SD NRS) was examined using the equipercentile linking method.

Results: In ARCADIA 1 (N = 941), most SSD parameters showed good test-retest reliability (intraclass correlations ≥ 0.70) in patients with stable scores over 1 week on sleep disturbance or itch measures. The SSD parameters of wakefulness after sleep onset (WASO), total awake time (TWT), sleep efficiency (SE), number of times (NWASO-AD) and duration (WASO-AD) of AD-related WASO, and sleep quality/refresh (SQR) showed moderate or strong correlations (r = 0.30-0.66) at baseline, in the expected direction; with the SD NRS and at least one of the measures assessing itch and skin disease-related quality of life (Pruritus Categorical Scale, Peak Pruritus NRS, Average Pruritus NRS, and Dermatology Life Quality Index). Correlations with measures assessing distal concepts were weak for most sleep parameters. Sleep onset latency (SOL), WASO, TWT, SE, NWASO-AD, WASO-AD, and SQR demonstrated good known-groups validity at baseline and week 16, and showed responsiveness based on most anchors used in the analysis. Values of the same percentile rankings for the SD NRS and each SSD parameter were identified. Comparable results were obtained using ARCADIA 2 data (N = 787).

Conclusions: The results provided evidence that the SSD, particularly its SOL, WASO, TWASO, TWT, SE, NWASO-AD, WASO-AD, and SQR parameters, is reliable and valid to measure multidimensional concepts of sleep disturbance in clinical studies.

Clinical trial registration: NCT03985943, NCT03989349.

Keywords: Atopic dermatitis; Patient-reported outcome; Psychometrics; Sleep disturbance.

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Conflict of interest statement

Declarations. Conflict of Interest: Jonathan I. Silverberg has received grants as a consultant and/or advisory board member for AbbVie, Alamar, Aldena, Amgen, AObiome, Arcutis, Arena, Asana, Aslan, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Cara, Castle Biosciences, Celgene, Connect Biopharma, Dermavant, Dermira, Dermtech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo Pharma, Menlo, Novartis, Optum, Pfizer, RAPT, Regeneron, Sanofi-Genzyme, Shaperon, Union; speaker for AbbVie, Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi-Genzyme; institution received grants from Galderma, Incyte, and Pfizer. Danielle N. Rodriguez, Carla Dias-Barbosa, and Dina Filipenko are employees of Evidera, which was paid by Galderma for work relating to this study. Liliana Ulianov, Christophe Piketty, and Jorge Puelles are employees of Galderma, which funded this study. Ethical Approval: The clinical trials that provided data for this study were conducted in accordance with the Helsinki Declaration of 1964 and its later amendments, good clinical practice guidelines, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. Both trials were initiated after approval from applicable regulatory authorities and the independent ethics committee or institutional review board at each participating site. All patients or their legal guardians provided written informed consent/assent prior to enrollment.

Figures

Fig. 1
Fig. 1
Equipercentile linking between SSD and SD NRS (ARCADIA 1). A Morning sleep diary metrics. B Evening sleep diary metrics. Data points represent values for the SD NRS and the respective SSD parameter that have the same percentile ranking. AD atopic dermatitis, DS-AD duration of daytime sleepiness due to AD, NDS-AD number of times of daytime sleepiness due to AD, NWASO-AD number of times of WASO related to AD, SD NRS Sleep Disturbance Numerical Rating Scale, SE sleep efficiency, SOL sleep onset latency, SQR sleep quality/refresh, SSD subject sleep diary, TIB time in bed, TST total sleep time, TWASO terminal wakefulness after sleep onset, TWT total awake time, WASO wakefulness after sleep onset, WASO-AD duration of WASO related to AD
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