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Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis

INTRODUCTION: Validated patient report tools for quantifying patient experiences of itch in prurigo nodularis (PN) are limited. This study aimed to evaluate the validity of the 11-point peak pruritus numerical rating scale (PP NRS) as a single-item patient-reported outcome (PRO) measure for assessin...

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Detalles Bibliográficos
Autores principales: Kwatra, Shawn G., Rodriguez, Danielle, Dias-Barbosa, Carla, Budhiarso, Ismail, Fofana, Fatoumata, Vernon, Margaret, Gabriel, Sylvie, Piketty, Christophe, Puelles, Jorge
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10539229/
https://www.ncbi.nlm.nih.gov/pubmed/37615836
http://dx.doi.org/10.1007/s13555-023-00999-9
Descripción
Sumario:INTRODUCTION: Validated patient report tools for quantifying patient experiences of itch in prurigo nodularis (PN) are limited. This study aimed to evaluate the validity of the 11-point peak pruritus numerical rating scale (PP NRS) as a single-item patient-reported outcome (PRO) measure for assessing itch severity in PN. METHODS: Content validity of the PP NRS was evaluated through qualitative interviews with adults with PN. The PP NRS was then psychometrically evaluated using data from a placebo-controlled trial of nemolizumab in adults with PN, during which patients completed the PP NRS daily. Meaningful within-patient change was estimated from the qualitative interviews and by anchor- and distribution-based analyses of trial data. RESULTS: The interview participants (N = 21) all understood the PP NRS and reported itch as their worst symptom overall. The PP NRS showed good test–retest reliability and demonstrated convergent validity and known-groups validity. PP NRS scores improved more in patients classified as “improved” on other clinical outcome measures than in those classified as “worsened/unchanged”. Triangulation of the different estimates identified a 2- to 5-point decrease in PP NRS score as a meaningful within-patient change threshold. CONCLUSION: The PP NRS is a content-valid and reliable PRO measure for quantifying itch severity in adults with PN in clinical trials. TRIAL REGISTRATION NUMBER: NCT03181503. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-023-00999-9.