ArticleDermatology and therapy2023
The Sleep Disturbance Numerical Rating Scale: Content Validity, Psychometric Validation, and Meaningful Within-Patient Change in Prurigo Nodularis.
Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03181503 (A Study to Assess the Safety and Efficacy of Nemolizumab), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Impact of Chronic Nodular Prurigo on Quality of Life: A Systematic Review of the Literature.Dermatology and therapy · 2026Pooled it
- Efficacy and Safety of Conventional and Biologic Therapies in Prurigo Nodularis: A Systematic Review and Meta-Analysis.International journal of dermatology · 2026Pooled it
- Which Interventions Are Effective in Treating Sleep Disturbances After THA or TKA? A Systematic Review.Clinical orthopaedics and related research · 2025Pooled it
- Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Trial
- Impact of positive expiratory pressure buddy during exercise on chronic obstructive pulmonary disease patients' functional performance, lung function, and sleep quality: a randomized controlled trial.European journal of physical and rehabilitation medicine · 2025Trial
- Trial
- Standardizing Prurigo Control Assessment Globally: Linguistic Validation and Cross-cultural Adaptation of Prurigo Control Test in 18 Languages.Acta dermato-venereologica · 2026Article
- The SWITCH algorithm: An expert consensus on treat-to-target criteria for chronic prurigo.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- The effects of tetrahydrocannabinol and cannabidiol on sleep in cancer patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Design and rationale for Exploring Predictors of successful healthCare Transition for adolescents with chronic conditions in a longitudinal explorative cohort.Health care transitions · 2026Article
- The Efficacy and Safety of Nemolizumab in Patients with Prurigo Nodularis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Dermatology practical & conceptual · 2025Article
- Article
- Content Validity and Psychometric Validation of an Adapted Version of the Subject Sleep Diary in Prurigo Nodularis.Dermatology and therapy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSleep is often disturbed in patients with prurigo nodularis (PN). To address the lack of validated patient-reported outcome (PRO) measures for quantifying sleep disturbance in PN, we evaluated the Sleep Disturbance Numerical Rating Scale (SD NRS) as a single-item PRO measure for quantifying sleep disturbance in PN.
methodsAdults with PN participated in qualitative interviews, which included concept elicitation and cognitive debriefing of the SD NRS. The SD NRS was evaluated psychometrically using data from a phase 2 randomized trial in adults with PN (NCT03181503). Other PRO assessments included the Average Pruritus (AP) NRS, AP Verbal Rating Scale (VRS), peak pruritus (PP) NRS, PP VRS, and Dermatology Life Quality Index (DLQI). Reliability, validity, and responsiveness of the SD NRS were evaluated, and meaningful within-patient change was estimated from qualitative interview responses and quantitative trial data.
resultsAll interview participants (N = 21) experienced sleep disturbance and most (95%) understood the SD NRS as intended. The SD NRS demonstrated test-retest reliability based on intra-class correlation coefficients for itch-stable participants of 0.87 for the AP VRS and 0.76 for the PP VRS. At baseline, Spearman's rank-order correlation coefficients were moderate to strong (0.3-0.8) between the SD NRS and the AP NRS, AP VRS, PP NRS, PP VRS, and DLQI. Known-groups validity was demonstrated by higher (worse) SD NRS scores in participants with worse scores on the AP NRS, AP VRS, PP VRS, and DLQI. Improvements in SD NRS scores were greater in participants classified as "improved" versus "worsened/unchanged" on the anchor PROs. A 2- to 4-point decrease on the 11-point SD NRS scale was identified as a meaningful within-patient change.
conclusionThe SD NRS is a well-defined, reliable, and valid PRO measure that can be used in daily practice and clinical trials to capture sleep disturbance in adults with PN.
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