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
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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. / Simpson, Eric; Bissonnette, Robert; Eichenfield, Lawrence F; Guttman-Yassky, Emma; King, Brett; Silverberg, Jonathan I; Beck, Lisa A; Bieber, Thomas; Reich, Kristian; Kabashima, Kenji; Seyger, Marieke; Siegfried, Elaine; Stingl, Georg; Feldman, Steven R; Menter, Alan; van de Kerkhof, Peter; Yosipovitch, Gil; Paul, Carle; Martel, Philippe; Dubost-Brama, Ariane; Armstrong, John; Chavda, Rajeev; Frey, Steve; Joubert, Yolandi; Milutinovic, Marina; Parneix, Anne; Teixeira, Henrique D; Lin, Chen-Yen; Sun, Luna; Klekotka, Paul; Nickoloff, Brian; Dutronc, Yves; Mallbris, Lotus; Janes, Jonathan M; DeLozier, Amy M; Nunes, Fabio P; Paller, Amy S.
In: J AM ACAD DERMATOL, Vol. 83, No. 3, 09.2020, p. 839-846.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - 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
AU - Simpson, Eric
AU - Bissonnette, Robert
AU - Eichenfield, Lawrence F
AU - Guttman-Yassky, Emma
AU - King, Brett
AU - Silverberg, Jonathan I
AU - Beck, Lisa A
AU - Bieber, Thomas
AU - Reich, Kristian
AU - Kabashima, Kenji
AU - Seyger, Marieke
AU - Siegfried, Elaine
AU - Stingl, Georg
AU - Feldman, Steven R
AU - Menter, Alan
AU - van de Kerkhof, Peter
AU - Yosipovitch, Gil
AU - Paul, Carle
AU - Martel, Philippe
AU - Dubost-Brama, Ariane
AU - Armstrong, John
AU - Chavda, Rajeev
AU - Frey, Steve
AU - Joubert, Yolandi
AU - Milutinovic, Marina
AU - Parneix, Anne
AU - Teixeira, Henrique D
AU - Lin, Chen-Yen
AU - Sun, Luna
AU - Klekotka, Paul
AU - Nickoloff, Brian
AU - Dutronc, Yves
AU - Mallbris, Lotus
AU - Janes, Jonathan M
AU - DeLozier, Amy M
AU - Nunes, Fabio P
AU - Paller, Amy S
N1 - Copyright © 2020. Published by Elsevier Inc.
PY - 2020/9
Y1 - 2020/9
N2 - 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.
AB - 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.
U2 - 10.1016/j.jaad.2020.04.104
DO - 10.1016/j.jaad.2020.04.104
M3 - SCORING: Journal article
C2 - 32344071
VL - 83
SP - 839
EP - 846
JO - J AM ACAD DERMATOL
JF - J AM ACAD DERMATOL
SN - 0190-9622
IS - 3
ER -