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.
J Am Acad Dermatol
; 83(3): 839-846, 2020 Sep.
Article
em En
| MEDLINE
| ID: mdl-32344071
ABSTRACT
BACKGROUND:
An Investigator Global Assessment (IGA) is recommended by health agencies for drug registration in atopic dermatitis (AD). Current IGA scales lack standardization.OBJECTIVES:
To develop an IGA scale, training module, and clinical certification examination for use in AD trials; establish content validity; and assess reliability.METHODS:
Expert dermatologists participated in the development of the validated IGA for AD (vIGA-ADTM). Reliability (interrater and intrarater) was assessed by 2 web-based surveys. Clinical certification for investigators consisted of a training module and examination.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:
Ratings were assessed on photographs.CONCLUSION:
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Índice de Gravidade de Doença
/
Avaliação de Resultados em Cuidados de Saúde
/
Consenso
/
Dermatite Atópica
Tipo de estudo:
Guideline
Limite:
Adult
/
Child
/
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article