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, E.
- Bissonnette, R.
- Eichenfield, L.F.
- Guttman-Yassky, E.
- King, B.
- Silverberg, J.I.
- Beck, L.A.
- Bieber, T.
- Reich, K.
- Kabashima, K.
- Seyger, M.M.B.
- Siegfried, E.
- Stingl, G.
- Feldman, S.R.
- Menter, A.
- Kerkhof, P. van de
- Yosipovitch, G.
- Paul, C.
- Martel, P.
- Dubost-Brama, A.
- Armstrong, J.
- Chavda, R.
- Frey, S.
- Joubert, Y.
- Milutinovic, M.
- Parneix, A.
- Teixeira, H.D.
- Lin, C.Y.
- Sun, L.
- Klekotka, P.
- Nickoloff, B.
- Dutronc, Y.
- Mallbris, L.
- Janes, J.M.
- DeLozier, A.M.
- Nunes, F.P.
- Paller, A.S.
DOIAbstract
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-AD(TM)). 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 establis...
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