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.

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.

• Authors: Eric Simpson, Robert Bissonnette, Lawrence F Eichenfield, Emma Guttman-Yassky, Brett King, Jonathan I Silverberg, Lisa A Beck, Thomas Bieber, Kristian Reich, Kenji Kabashima, Marieke Seyger, Elaine Siegfried, Georg Stingl, Steven R Feldman, Alan Menter, Peter van de Kerkhof, Gil Yosipovitch, Carle Paul, Philippe Martel, Ariane Dubost-Brama, John Armstrong, Rajeev Chavda, Steve Frey, Yolandi Joubert, Marina Milutinovic, Anne Parneix, Henrique D Teixeira, Chen-Yen Lin, Luna Sun, Paul Klekotka, Brian Nickoloff, Yves Dutronc, Lotus Mallbris, Jonathan M Janes, Amy M DeLozier, Fabio P Nunes, Amy S Paller
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 83 Issue 3 Pg. 839-846 (Sep 2020) ISSN: 1097-6787 [Electronic] United States
• PMID: 32344071 (Publication Type: Journal Article, Validation Study)
• Copyright: Copyright © 2020. Published by Elsevier Inc.

Topics

• Adult
• Child
• Consensus
• Consensus Development Conferences as Topic
• Dermatitis, Atopic (diagnosis, therapy)
• Dermatologists (standards, statistics & numerical data)
• 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