Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis.

Autor: Silverberg JI; George Washington University, Washington, DC, USA., DeLozier A; Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA. delozier_amy@lilly.com., Sun L; Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA., Thyssen JP; Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark., Kim B; Pied Piper Consulting, LLC, St. Louis, MO, USA., Yosipovitch G; Miller School of Medicine, University of Miami, Miami, FL, USA., Nunes FP; Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA., Gugiu PC; Clinical Outcomes Solutions, Chicago, IL, USA., Doll HA; Clinical Outcomes Solutions, Folkestone, Kent, UK., Eichenfield LF; University of California San Diego, San Diego, CA, USA.; Rady Children's Hospital, San Diego, CA, USA.
Jazyk: angličtina
Zdroj: Health and quality of life outcomes [Health Qual Life Outcomes] 2021 Oct 23; Vol. 19 (1), pp. 247. Date of Electronic Publication: 2021 Oct 23.
DOI: 10.1186/s12955-021-01877-8
Abstrakt: Background: The Itch Numeric Rating Scale (NRS), Skin Pain NRS, and Atopic Dermatitis Sleep Scale (ADSS) are self-administered patient-reported outcome (PRO) instruments developed to assess symptoms in patients with atopic dermatitis (AD). The objective of this study was to evaluate the psychometric properties (reliability, validity, and responsiveness) and interpretability thresholds of these PROs using data from three pivotal Phase 3 studies in adults.
Methods: BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5 evaluated the safety and efficacy of baricitinib in adults with moderate-to-severe AD. Clinician-reported outcomes and other PROs commonly assessed in patients with AD were used to estimate meaningful changes and evaluate test-retest reliability, convergent and divergent validity, known-groups validity, responsiveness, and meaningful change thresholds (MCTs) of the Itch NRS, Skin Pain NRS, and ADSS.
Results: The test-retest reliability of the Itch NRS, Skin Pain NRS, and ADSS was evidenced by generally large intraclass correlation coefficients (> 0.7) in stable groups of patients between baseline and Week 1 and Weeks 4 and 8. Moderate-to-large correlations (r > 0.4) at baseline and Week 16 were generally observed between each measure and other PROs measuring the same concept, supporting convergent validity. Small-to-moderate correlations with clinician-reported outcomes demonstrated divergent validity. Each instrument was able to distinguish between known groups of disease severity as assessed using other indicators of AD severity. The responsiveness of the Itch NRS, Skin Pain NRS, and ADSS scales was demonstrated through significant differences in their change scores from baseline to Week 16 between categories of change in another PRO also from baseline to Week 16. Thresholds for interpreting meaningful change were estimated as - 4.0 for the 0-10 Itch and Skin Pain NRS items; - 1.25 for the 0-4 ADSS Items 1 and 3 and; - 1.50 for the 0-29 ADSS Item 2, these equivalent to moderate degrees of change.
Conclusions: Results of this study demonstrate that the psychometric properties of the Itch NRS, Skin Pain NRS, and ADSS are good to excellent. These findings support the use of these instruments in daily assessment of AD symptoms in adults with moderate-to-severe AD. Trial registration ClinicalTrials.gov numbers: NCT03334396, NCT03334422, and NCT03435081.
(© 2021. The Author(s).)
Databáze: MEDLINE
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