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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.
Affiliation
  • Simpson E; Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu.
  • Bissonnette R; Innovaderm Research Inc, Montréal, Canada.
  • Eichenfield LF; University of California San Diego, San Diego, California.
  • Guttman-Yassky E; Mount Sinai School of Medicine, New York, New York.
  • King B; Yale School of Medicine, New Haven, Connecticut.
  • Silverberg JI; The George Washington University School of Medicine and Health Sciences, Washington, DC.
  • Beck LA; University of Rochester Medical Center, Rochester, New York.
  • Bieber T; University of Bonn, Bonn, Germany.
  • Reich K; 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.
  • Kabashima K; Kyoto University, Kyoto, Japan.
  • Seyger M; Radboud University Medical Center, Nijmegen, The Netherlands.
  • Siegfried E; Saint Louis University, Saint Louis, Missouri.
  • Stingl G; Medical University of Vienna, Vienna, Austria.
  • Feldman SR; Wake Forest School of Medicine, Winston-Salem, North Carolina.
  • Menter A; Baylor Scott & White Health, Dallas, Texas.
  • van de Kerkhof P; Radboud University Medical Center, Nijmegen, The Netherlands.
  • Yosipovitch G; University of Miami, Miami, Florida.
  • Paul C; Toulouse University, Toulouse, France.
  • Martel P; Galderma, Sophia Antipolis, France; Eli Lilly and Company, Indianapolis, Indiana.
  • Dubost-Brama A; Galderma, Sophia Antipolis, France.
  • Armstrong J; Galderma, Sophia Antipolis, France.
  • Chavda R; Galderma, Sophia Antipolis, France.
  • Frey S; GlaxoSmithKline, Collegeville, Pennsylvania.
  • Joubert Y; Novartis Pharma AG, Basel, Switzerland.
  • Milutinovic M; Novartis Pharma AG, Basel, Switzerland.
  • Parneix A; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
  • Teixeira HD; AbbVie Inc, North Chicago, Illinois.
  • Lin CY; Eli Lilly and Company, Indianapolis, Indiana.
  • Sun L; Eli Lilly and Company, Indianapolis, Indiana.
  • Klekotka P; Eli Lilly and Company, Indianapolis, Indiana.
  • Nickoloff B; Eli Lilly and Company, Indianapolis, Indiana.
  • Dutronc Y; Eli Lilly and Company, Indianapolis, Indiana.
  • Mallbris L; Eli Lilly and Company, Indianapolis, Indiana.
  • Janes JM; Eli Lilly and Company, Indianapolis, Indiana.
  • DeLozier AM; Eli Lilly and Company, Indianapolis, Indiana.
  • Nunes FP; Eli Lilly and Company, Indianapolis, Indiana.
  • Paller AS; The George Washington University School of Medicine and Health Sciences, Washington, DC.
J Am Acad Dermatol ; 83(3): 839-846, 2020 Sep.
Article in En | MEDLINE | ID: mdl-32344071
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Severity of Illness Index / Outcome Assessment, Health Care / Consensus / Dermatitis, Atopic Type of study: Guideline Limits: Adult / Child / Humans Language: En Journal: J Am Acad Dermatol Year: 2020 Document type: Article
Fulltext
Add to My VHL
Print
XML
PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Severity of Illness Index / Outcome Assessment, Health Care / Consensus / Dermatitis, Atopic Type of study: Guideline Limits: Adult / Child / Humans Language: En Journal: J Am Acad Dermatol Year: 2020 Document type: Article