Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Sep;83(3):839-846.
doi: 10.1016/j.jaad.2020.04.104. Epub 2020 Apr 25.

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

Eric Simpson  1 , Robert Bissonnette  2 , Lawrence F Eichenfield  3 , Emma Guttman-Yassky  4 , Brett King  5 , Jonathan I Silverberg  6 , Lisa A Beck  7 , Thomas Bieber  8 , Kristian Reich  9 , Kenji Kabashima  10 , Marieke Seyger  11 , Elaine Siegfried  12 , Georg Stingl  13 , Steven R Feldman  14 , Alan Menter  15 , Peter van de Kerkhof  11 , Gil Yosipovitch  16 , Carle Paul  17 , Philippe Martel  18 , Ariane Dubost-Brama  19 , John Armstrong  19 , Rajeev Chavda  19 , Steve Frey  20 , Yolandi Joubert  21 , Marina Milutinovic  21 , Anne Parneix  22 , Henrique D Teixeira  23 , Chen-Yen Lin  24 , Luna Sun  24 , Paul Klekotka  24 , Brian Nickoloff  24 , Yves Dutronc  24 , Lotus Mallbris  24 , Jonathan M Janes  24 , Amy M DeLozier  24 , Fabio P Nunes  24 , Amy S Paller  6
Affiliations

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

Eric Simpson et al. J Am Acad Dermatol. 2020 Sep.

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.

Keywords: Investigator Global Assessment; atopic dermatitis; atopic eczema; clinical outcome measure; severity; validated.

PubMed Disclaimer

Publication types