ArticleDermatology and therapy2025
Content Validity and Psychometric Validation of an Adapted Version of the Subject Sleep Diary in Prurigo Nodularis.
Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
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9 authors.
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Abstract
introductionPatients with prurigo nodularis (PN) often experience sleep disturbance. A psychometric evaluation was conducted to assess the suitability of a PN-adapted multi-item subject sleep diary (SSD) for measuring PN-related sleep disturbance.
methodsContent validity of the SSD was evaluated through qualitative interviews with adults with PN (N = 21). Psychometric properties of SSD parameters (sleep onset latency [SOL], wakefulness after sleep onset [WASO], total awake time [TWT], total sleep time [TST], sleep efficiency [SE], PN-related WASO [WASO-PN], number of WASO-PN, and sleep quality/refresh [SQR]) were evaluated using data from adults with moderate-to-severe PN in the phase 3 OLYMPIA trials (NCT04501666 [N = 286], NCT04501679 [N = 274]). The relationship between SSD parameters and the single-item Sleep Disturbance Numerical Rating Scale (SD-NRS) was examined using equipercentile linking.
resultsMost interview participants who responded to cognitive debriefing questions understood the SSD as intended (≥ 80% for each item), confirming content validity. All SSD parameters showed good test-retest reliability. At week 16, all SSD parameters but TST showed moderate-to-strong correlations, in the expected direction, with the SD-NRS, Peak Pruritus NRS (PP-NRS), Average Pruritus (AP) NRS, Dermatology Life Quality Index (DLQI), PN-related pain frequency and intensity, Prurigo Activity and Severity Score (PAS), and/or Investigator's Global Assessment (IGA). Known-groups validity was adequate for all SSD parameters based on the Patient Global Impression of Severity-Sleep Disturbance (PGIS-SD), Patient Global Assessment of Disease (PGAD), PP-NRS, DLQI, and/or IGA. All parameters but TST were responsive to improvements on the PGIS-SD, Patient Global Impression of Change-Sleep Disturbance, PGAD, PP-NRS, AP NRS, PN-related pain intensity, DLQI, and/or IGA. Cross-sectional values or value changes of the SD-NRS were moderately to strongly correlated with SSD parameters, and equipercentile linking analyses revealed non-linear relationships between the measures.
conclusionsThe findings suggest that the SSD is a fit-for-purpose measure that can be used to assess sleep disturbance in moderate-to-severe PN. CLINICAL
trial registrationNCT04501666, NCT04501679.
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