Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate‐to‐severe atopic dermatitis. (1st May 2019)

• Record Type: Journal Article
• Authors: Yosipovitch, G.; Reaney, M.; Mastey, V.; Eckert, L.; Abbé, A.; Nelson, L.; Clark, M.; Williams, N.; Chen, Z.; Ardeleanu, M.; Akinlade, B.; Graham, N.M.H.; Pirozzi, G.; Staudinger, H.; Plaum, S.; Radin, A.; Gadkari, A.
• Is Part Of: British journal of dermatology. Volume 181:Number 4(2019)
• Page Start: 761
• Page End: 769
• Publication Date: 2019-05-01
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.17744
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Moderate‐to‐severe atopic dermatitis (AD) is a chronic disease characterized by intense, persistent and debilitating itch, resulting in sleep deprivation, signs of anxiety and depression, impaired quality of life and reduced productivity. The Peak Pruritus Numerical Rating Scale (NRS) was developed and validated as a single‐item, patient‐reported outcome (PRO) of itch severity. Objectives: To describe the content validity and psychometric assessment (test–retest reliability, construct validity, known‐groups validity, sensitivity to change) of the Peak Pruritus NRS, and to derive empirically a responder definition to identify adults with a meaningful change in itch. Methods: Content validity was assessed through in‐depth patient interviews. Psychometric assessments used data from phase IIb and phase III dupilumab clinical trials and included test–retest reliability, construct validity, known‐groups validity and sensitivity to change in patients with moderate‐to‐severe AD. Results: Interview participants indicated that the Peak Pruritus NRS was a relevant, clear and comprehensive assessment of itch severity. Peak Pruritus NRS scores showed large, positive correlations with existing PRO measures of itch, and weak or moderate correlations with clinician‐reported measures assessing objective signs of AD. Peak Pruritus NRS score improvements were highly correlated with improvements in other itch PROs, and moderately correlated with improvements in clinician‐reported measures assessing objective signs of AD. The most appropriate threshold for defining a clinically relevant, within‐person response was ≥ 2–4‐point change in the Peak Pruritus NRS. Conclusions: The Peak Pruritus NRS is a well‐defined, reliable, sensitive and valid scale for evaluating worst itch intensity in adults with moderate‐to‐severe AD. Abstract : What's already known about this topic? Moderate‐to‐severe atopic dermatitis is characterized by persistent and debilitating itch, which can greatly impair quality of life. A validated, brief patient‐reported outcome measure is needed to quantify the intensity of itch accurately and reliably in patients with atopic dermatitis in clinical trials. What does this study add? The Peak Pruritus Numerical Rating Scale (NRS) is a well‐defined, reliable, fit‐for‐purpose measure to evaluate patient‐reported intensity of worst itch in the previous 24 h for adults with moderate‐to‐severe atopic dermatitis. Clinical response is indicated by a ≥ 2–4‐point change from baseline in Peak Pruritus NRS score. What are the clinical implications of this work? This study provides practising clinicians and clinical trialists with a validated patient‐reported outcome measure to assess itch, a hallmark symptom of atopic dermatitis and a crucial marker of treatment benefit. Plain language summary available online Respond to this article