Eric Simpson1, Robert Bissonnette2, Lawrence F Eichenfield3, Emma Guttman-Yassky4, Brett King5, Jonathan I Silverberg6, Lisa A Beck7, Thomas Bieber8, Kristian Reich9, Kenji Kabashima10, Marieke Seyger11, Elaine Siegfried12, Georg Stingl13, Steven R Feldman14, Alan Menter15, Peter van de Kerkhof11, Gil Yosipovitch16, Carle Paul17, Philippe Martel18, Ariane Dubost-Brama19, John Armstrong19, Rajeev Chavda19, Steve Frey20, Yolandi Joubert21, Marina Milutinovic21, Anne Parneix22, Henrique D Teixeira23, Chen-Yen Lin24, Luna Sun24, Paul Klekotka24, Brian Nickoloff24, Yves Dutronc24, Lotus Mallbris24, Jonathan M Janes24, Amy M DeLozier24, Fabio P Nunes24, Amy S Paller6. 1. Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu. 2. Innovaderm Research Inc, Montréal, Canada. 3. University of California San Diego, San Diego, California. 4. Mount Sinai School of Medicine, New York, New York. 5. Yale School of Medicine, New Haven, Connecticut. 6. The George Washington University School of Medicine and Health Sciences, Washington, DC. 7. University of Rochester Medical Center, Rochester, New York. 8. University of Bonn, Bonn, Germany. 9. Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf; Skinflammation Center Hamburg, Hamburg, Germany. 10. Kyoto University, Kyoto, Japan. 11. Radboud University Medical Center, Nijmegen, The Netherlands. 12. Saint Louis University, Saint Louis, Missouri. 13. Medical University of Vienna, Vienna, Austria. 14. Wake Forest School of Medicine, Winston-Salem, North Carolina. 15. Baylor Scott & White Health, Dallas, Texas. 16. University of Miami, Miami, Florida. 17. Toulouse University, Toulouse, France. 18. Galderma, Sophia Antipolis, France; Eli Lilly and Company, Indianapolis, Indiana. 19. Galderma, Sophia Antipolis, France. 20. GlaxoSmithKline, Collegeville, Pennsylvania. 21. Novartis Pharma AG, Basel, Switzerland. 22. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. 23. AbbVie Inc, North Chicago, Illinois. 24. Eli Lilly and Company, Indianapolis, Indiana.
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.
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.
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