TY - JOUR
T1 - The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
T2 - 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 - Publisher Copyright:
© 2020
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.
KW - Investigator Global Assessment
KW - atopic dermatitis
KW - atopic eczema
KW - clinical outcome measure
KW - severity
KW - validated
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U2 - 10.1016/j.jaad.2020.04.104
DO - 10.1016/j.jaad.2020.04.104
M3 - Article
C2 - 32344071
AN - SCOPUS:85088114040
SN - 0190-9622
VL - 83
SP - 839
EP - 846
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 3
ER -