The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis.
Adult
Child
Consensus
Consensus Development Conferences as Topic
Dermatitis, Atopic
/ diagnosis
Dermatologists
/ standards
Humans
Observer Variation
Outcome Assessment, Health Care
/ standards
Photography
Reproducibility of Results
Severity of Illness Index
Skin
/ diagnostic imaging
Surveys and Questionnaires
/ statistics & numerical data
Telecommunications
Investigator Global Assessment
atopic dermatitis
atopic eczema
clinical outcome measure
severity
validated
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
12
11
2019
revised:
17
04
2020
accepted:
20
04
2020
pubmed:
29
4
2020
medline:
9
3
2021
entrez:
29
4
2020
Statut:
ppublish
Résumé
An Investigator Global Assessment (IGA) is recommended by health agencies for drug registration in atopic dermatitis (AD). Current IGA scales lack standardization. To develop an IGA scale, training module, and clinical certification examination for use in AD trials; establish content validity; and assess reliability. Expert dermatologists participated in the development of the validated IGA for AD (vIGA-AD Expert consensus was achieved around a 5-point IGA scale including morphologic descriptions, and content validity was established. Survey 1 showed strong interrater reliability (Kendall's coefficient of concordance W [Kendall's W], 0.809; intraclass correlation [ICC], 0.817) and excellent agreement (weighted kappa, 0.857). Survey 2, completed 5 months after training of dermatologists, showed improvements in scale reliability (Kendall's W, 0.819; ICC, 0.852; weighted kappa, 0.889). In this study, 627 investigators completed vIGA-AD training and certification. Ratings were assessed on photographs. A validated IGA scale and training module were developed with the intent of harmonizing assessment of disease severity in AD trials. Strong reliability and excellent agreement between assessments were observed.
Sections du résumé
BACKGROUND
BACKGROUND
An Investigator Global Assessment (IGA) is recommended by health agencies for drug registration in atopic dermatitis (AD). Current IGA scales lack standardization.
OBJECTIVES
OBJECTIVE
To develop an IGA scale, training module, and clinical certification examination for use in AD trials; establish content validity; and assess reliability.
METHODS
METHODS
Expert dermatologists participated in the development of the validated IGA for AD (vIGA-AD
RESULTS
RESULTS
Expert consensus was achieved around a 5-point IGA scale including morphologic descriptions, and content validity was established. Survey 1 showed strong interrater reliability (Kendall's coefficient of concordance W [Kendall's W], 0.809; intraclass correlation [ICC], 0.817) and excellent agreement (weighted kappa, 0.857). Survey 2, completed 5 months after training of dermatologists, showed improvements in scale reliability (Kendall's W, 0.819; ICC, 0.852; weighted kappa, 0.889). In this study, 627 investigators completed vIGA-AD training and certification.
LIMITATIONS
CONCLUSIONS
Ratings were assessed on photographs.
CONCLUSION
CONCLUSIONS
A validated IGA scale and training module were developed with the intent of harmonizing assessment of disease severity in AD trials. Strong reliability and excellent agreement between assessments were observed.
Identifiants
pubmed: 32344071
pii: S0190-9622(20)30720-9
doi: 10.1016/j.jaad.2020.04.104
pii:
doi:
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
839-846Informations de copyright
Copyright © 2020. Published by Elsevier Inc.