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Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis
INTRODUCTION: Itch associated with atopic dermatitis (AD) has a profoundly negative effect on patients of all ages. Therefore, itch is a main target for AD therapeutic approaches, and treatments are perceived as beneficial when they achieve an itch reduction. In the absence of a validated scale for...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9674819/ https://www.ncbi.nlm.nih.gov/pubmed/36269504 http://dx.doi.org/10.1007/s13555-022-00804-z |
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author | Paller, Amy S. Yosipovitch, Gil Weidinger, Stephan DiBenedetti, Dana Whalley, Diane Gadkari, Abhijit Guillemin, Isabelle Zhang, Haixin Eckert, Laurent Chao, Jingdong Bansal, Ashish Chuang, Chien-Chia Delevry, Dimittri |
author_facet | Paller, Amy S. Yosipovitch, Gil Weidinger, Stephan DiBenedetti, Dana Whalley, Diane Gadkari, Abhijit Guillemin, Isabelle Zhang, Haixin Eckert, Laurent Chao, Jingdong Bansal, Ashish Chuang, Chien-Chia Delevry, Dimittri |
author_sort | Paller, Amy S. |
collection | PubMed |
description | INTRODUCTION: Itch associated with atopic dermatitis (AD) has a profoundly negative effect on patients of all ages. Therefore, itch is a main target for AD therapeutic approaches, and treatments are perceived as beneficial when they achieve an itch reduction. In the absence of a validated scale for children aged 6–11 years that is suitable for assessing itch intensity in clinical trial settings, the Worst Itch Scale was developed. METHODS: Qualitative interviews, comprising concept elicitation and cognitive debriefing, were conducted to develop and evaluate the content validity of the Worst Itch Scale. Psychometric assessments used data from the LIBERTY AD PEDS phase 3 trial of dupilumab in patients aged 6–11 years with severe AD. These included test–retest reliability, construct validity, known-groups validity and responsiveness. Thresholds for clinically meaningful change were defined using anchor- and distribution-based methods. RESULTS: The Worst Itch Scale consisted of two items asking about ‘worst itching’ experienced ‘last night’ and ‘today’. Worst Itch Scale scores showed large, positive correlations with existing patient-reported outcome (PRO) measures of itch, and weaker correlations with clinician-reported outcome (ClinRO) measures assessing objective signs of AD. Improvements in Worst Itch Scale scores were highly correlated with improvements in other itch PROs and moderately correlated with improvements in ClinROs. The responder definition based on the primary anchor, a 1-point improvement in the Patient Global Impression of Disease, was 2.84. Supportive anchors produced response estimates ranging from 2.43 to 4.80 points. CONCLUSIONS: The Worst Itch Scale is a fit-for-purpose (e.g. well-defined, reliable, responsive and valid) scale for evaluating worst itch intensity in children aged 6–11 years with severe AD. The within-patient threshold for defining a clinically meaningful response was a ≥ 3–4-point change in the Worst Itch Scale score. TRIAL REGISTRATION: NCT03345914. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-022-00804-z. |
format | Online Article Text |
id | pubmed-9674819 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-96748192022-11-20 Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis Paller, Amy S. Yosipovitch, Gil Weidinger, Stephan DiBenedetti, Dana Whalley, Diane Gadkari, Abhijit Guillemin, Isabelle Zhang, Haixin Eckert, Laurent Chao, Jingdong Bansal, Ashish Chuang, Chien-Chia Delevry, Dimittri Dermatol Ther (Heidelb) Brief Report INTRODUCTION: Itch associated with atopic dermatitis (AD) has a profoundly negative effect on patients of all ages. Therefore, itch is a main target for AD therapeutic approaches, and treatments are perceived as beneficial when they achieve an itch reduction. In the absence of a validated scale for children aged 6–11 years that is suitable for assessing itch intensity in clinical trial settings, the Worst Itch Scale was developed. METHODS: Qualitative interviews, comprising concept elicitation and cognitive debriefing, were conducted to develop and evaluate the content validity of the Worst Itch Scale. Psychometric assessments used data from the LIBERTY AD PEDS phase 3 trial of dupilumab in patients aged 6–11 years with severe AD. These included test–retest reliability, construct validity, known-groups validity and responsiveness. Thresholds for clinically meaningful change were defined using anchor- and distribution-based methods. RESULTS: The Worst Itch Scale consisted of two items asking about ‘worst itching’ experienced ‘last night’ and ‘today’. Worst Itch Scale scores showed large, positive correlations with existing patient-reported outcome (PRO) measures of itch, and weaker correlations with clinician-reported outcome (ClinRO) measures assessing objective signs of AD. Improvements in Worst Itch Scale scores were highly correlated with improvements in other itch PROs and moderately correlated with improvements in ClinROs. The responder definition based on the primary anchor, a 1-point improvement in the Patient Global Impression of Disease, was 2.84. Supportive anchors produced response estimates ranging from 2.43 to 4.80 points. CONCLUSIONS: The Worst Itch Scale is a fit-for-purpose (e.g. well-defined, reliable, responsive and valid) scale for evaluating worst itch intensity in children aged 6–11 years with severe AD. The within-patient threshold for defining a clinically meaningful response was a ≥ 3–4-point change in the Worst Itch Scale score. TRIAL REGISTRATION: NCT03345914. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-022-00804-z. Springer Healthcare 2022-10-21 /pmc/articles/PMC9674819/ /pubmed/36269504 http://dx.doi.org/10.1007/s13555-022-00804-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Brief Report Paller, Amy S. Yosipovitch, Gil Weidinger, Stephan DiBenedetti, Dana Whalley, Diane Gadkari, Abhijit Guillemin, Isabelle Zhang, Haixin Eckert, Laurent Chao, Jingdong Bansal, Ashish Chuang, Chien-Chia Delevry, Dimittri Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis |
title | Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis |
title_full | Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis |
title_fullStr | Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis |
title_full_unstemmed | Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis |
title_short | Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis |
title_sort | development, psychometric validation and responder definition of worst itch scale in children with severe atopic dermatitis |
topic | Brief Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9674819/ https://www.ncbi.nlm.nih.gov/pubmed/36269504 http://dx.doi.org/10.1007/s13555-022-00804-z |
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