Sonja Ständer, Danielle N Rodriguez, Carla Dias-Barbosa, Dina Filipenko, Jorge Puelles, Zarif K Jabbar-Lopez, Christophe Piketty, Henning Wiegmann, Shawn G Kwatra
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引用次数: 0
Abstract
Introduction: Patients 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.
Methods: Content 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.
Results: Most 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.
Conclusions: The findings suggest that the SSD is a fit-for-purpose measure that can be used to assess sleep disturbance in moderate-to-severe PN.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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