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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 839-846 |
| Number of pages | 8 |
| Journal | Journal of the American Academy of Dermatology |
| Volume | 83 |
| Issue number | 3 |
| DOIs | |
| State | Published - Sep 2020 |
Keywords
- Investigator Global Assessment
- atopic dermatitis
- atopic eczema
- clinical outcome measure
- severity
- validated
ASJC Scopus subject areas
- Dermatology
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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. et al.
In: Journal of the American Academy of Dermatology, Vol. 83, No. 3, 09.2020, p. 839-846.Research output: Contribution to journal › Article › peer-review
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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 - Funding Information: Funding sources: Supported by Eli Lilly and Company.Disclosure: Dr Simpson reports grants and fees for participation as a consultant and principal investigator from Eli Lilly and Company, LEO Pharma, Pfizer, and Regeneron; grants for participation as a principal investigator from Galderma and Merck & Co; and fees for consultant services from AbbVie, Boehringer Ingelheim, Dermavant, Incyte, Forte Bio, Pierre Fabre Dermo, and Sanofi Genzyme. Dr Bissonnette is an investigator, consultant, advisory board member, and/or speaker for and/or receives honoraria from AbbVie, Aquinox Pharma, Antiobix, Asana, Astellas, Boehringer Ingelheim, Brickell Biotech, Dermavant, Dermira, Dignity Sciences, Eli Lilly and Company, Galderma, Glenmark, GlaxoSmithKline-Stiefel, Hoffman-LaRoche Ltd, Incyte, Kiniksa, LEO Pharma, Neokera, Pfizer, Relaxer, Regeneron, Sanofi, Sienna, and Vitae and is an employee and shareholder of Innovaderm Research. Dr Eichenfield reports grants and fees for participation as a consultant and investigator from AbbVie, Eli Lilly and Company, Incyte, LEO Pharma, Pfizer, and Regeneron; fees for consulting services from Allergan, Dermavant, Dermira, Forte Bio, Galderma, Matrisys, Novartis, Regeneron, and Sanofi Genzyme; and honoraria and fees from Asana, Eli Lilly and Company, and Glenmark for data safety monitoring board services. Dr Guttman-Yassky is a consultant for AbbVie, Almirall, Amgen, Asana Biosciences, Boehringer Ingelheim, Cara Therapeutics, Celgene, Concert, DBV Technologies, Dermira, DS Biopharma, Eli Lilly and Company, EMD Serono, Escalier, Galderma, Glenmark, Kyowa Kirin, LEO Pharma, Mitsubishi Tanabe, Pfizer, RAPT Therapeutics, Regeneron, Sanofi, Sienna Biopharma, and Union Therapeutics and reports institute grants for research from AbbVie, Almirall, Amgen, AnaptysBio, Asana Biosciences, Boehringer Ingelheim, Celgene, Dermavant, DS Biopharma, Eli Lilly and Company, Glenmark, Galderma, Innovaderm, Janssen, Kiniksa, Kyowa Kirin, Leo Pharma, Novan, Pfizer, Ralexar, Regeneron, Sienna Biopharma, UCB, and Union Therapeutics. Dr King reports honoraria and/or fees for service on advisory boards and/or as consultant and/or as clinical trial investigator for Aclaris Therapeutics, Arena Pharmaceuticals, Bristol-Meyers Squibb, Concert Pharmaceuticals Inc, Dermavant Sciences, Eli Lilly and Company, and Pfizer Inc and is on the speaker's bureau for Pfizer Inc, Regeneron, and Sanofi Genzyme. Dr Silverberg reports honoraria for consultant and advisory board services and for participation as an investigator from Eli Lilly and Company. Dr Beck reports honoraria for advisory board or consulting services from AbbVie, Allakos, Arena Pharmaceuticals, AstraZeneca, Connect Biopharma, Eli Lilly and Company, LEO Pharma, Novan, Novartis, Pfizer, Regeneron, Sanofi, UCB, and Vimalan; reports grants for services as an investigator from AbbVie, LEO Pharma, Pfizer, and Regeneron; and owns stock in Pfizer and Medtronic. Dr Bieber reports honoraria for advisory board and/or consultancy services from AbbVie, Almirall, AnaptysBio, Arena Pharmaceuticals, Asana, Daiichi-Sankyo, Dermavant, Galapagos, GlaxoSmithKline, Glenmark Pharma, Incyte, Kymab, Kyowa Hakko Kirin, LEO Pharma, Menlo Therapeutics, Novartis, and Regeneron/Sanofi. Dr Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Covagen, Eli Lilly and Company, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, and Xenoport. Dr Kabashima has received honoraria and/or grant support from Japan Tobacco, LEO Pharma, Maruho, Mitsubishi Tanabe, Ono, P&G, and Taiho; consultant fees from Sanofi; and fees for lectures from Toril. Dr Seyger reports grant funding/was involved in clinical trials from AbbVie, Eli Lilly and Company, Janssen, and LEO Pharma and has served as a consultant for AbbVie, Eli Lilly and Company, Janssen, LEO Pharma, and Pfizer; fees were paid directly to the institute. Dr Siegfried was a paid consultant for Eli Lilly and Company during the conduct of the study and has been a paid investigator and/or consultant outside of the submitted work for AbbVie, Amgen, Anacor, Dermavant, Janssen, LEO Pharma, Novan, Pfizer, Pierre Fabre, Regeneron, Sanofi Genzyme, UCB, Valeant, and Verrica. Dr Stingl reports honoraria for lectures from AbbVie, Eli Lilly and Company, Janssen, Novartis, and Sanofi; honoraria for advisory services from AbbVie, Eli Lilly and Company, Incyte, and Janssen; and honoraria for consultancy services from Janssen and Sanofi. Dr Feldman reports honoraria and grants for consulting, speaking, and research from Celgene, Eli Lilly and Company, Novartis, and Ortho Dermatology; honoraria for consulting and speaking from Janssen and LEO Pharma; honoraria for speaking from AbbVie; honoraria for consultancy services from Almirall and Samsung; and honoraria for advisory services from Boehringer Ingelheim and Merck & Co. Dr Menter reports honoraria and grants for consultant, speaking, investigator, and advisory services from Abbott Laboratories, Amgen, Janssen, LEO Pharma, and Sienna; honoraria and grants for advisory and investigator services from Boehringer Ingelheim; honoraria for investigator and consultancy services from Eli Lilly and Company and Novartis; honoraria for consultant, speaker, and investigator services from UCB; and grants for investigator services from Celgene and Merck & Co. Dr van de Kerkhof reports consultancy services for AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Centocor, Dermavant, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Philips, Sandoz, Sandoz, and UCB. Dr Yosipovitch reports consulting support and research grants from Bellus, Eli Lilly and Company, Galderma, Kiniksa, Menlo, Novartis, Pfizer, Sanofi/Regeneron, Leo, Sun Pharma, and Trevi. Dr Paul reports honoraria and grants for consultancy services from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Pierre Fabre, and Sanofi/Regeneron. Dr Martel was an employee of Eli Lilly and Company and Galderma at the time of this study. Author Frey is an employee of GlaxoSmithKline Pharmaceuticals. Author Joubert is an employee of and stockholder in Novartis Pharma AG. Dr Milutinovic is an employee of and stockholder in Novartis Pharma AG. Dr Parneix is an employee of and stockholder in Novartis Pharmaceuticals Corporation. Dr Teixeira is an employee of and stockholder in AbbVie. Drs Lin, Sun, Klekotka, Nickoloff, Dutronc, Mallbris, Janes, Author DeLozier, and Dr Nunes are employees of and stockholders in Eli Lilly and Company. Dr Paller reports grants from AbbVie, AnaptysBio, Castle Creek, Eli Lilly and Company, Galderma, Incyte, LEO Pharma, Janssen, Novartis, and Regeneron and personal fees from AbbVie, Amgen, Asana, Castle Creek, Dermavant, Dermira, Eli Lilly and Company, Forte, Galderma, LEO Pharma, Matrisys, Menlo, Morphosys/Galapagos, Novartis, Patagonia, Pfizer, Pierre Fabre, Regeneron, Sanofi, and UCB. Drs Dubost-Brama, Armstrong, and Chavda have no conflicts of interest to declare. Funding Information: The authors thank Dr Amanda Oakley, DermnetNZ, for contributions to image selection and Eric Zudak and Brent Smith, Trifecta Clinical, for their support with implementation of the surveys. Medical writing support was provided by Amy Ellinwood, PhD, of Eli Lilly and Company and Prudence Stanford, PhD, of Syneos Health, funded by Eli Lilly and Company. Editorial support was provided by Antonia Baldo of Syneos Health, funded by Eli Lilly and Company. Funding Information: Funding sources: Supported by Eli Lilly and Company . 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
UR - http://www.scopus.com/inward/record.url?scp=85088114040&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85088114040&partnerID=8YFLogxK
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 -