A Global eDelphi Exercise to Identify Core Domains and Domain Items for the Development of a Global Registry of Alopecia Areata Disease Severity and Treatment Safety (GRASS)

Dmitri Wall, Nekma Meah, Katherine York, Bevin Bhoyrul, Laita Bokhari, Leonardo Spagnol Abraham, Roisín Adams, Wilma Bergfeld, Regina C. Betz, Ulrike Blume-Peytavi, Valerie Callender, Chel Campbell, Jen Chambers, Gang Chen, Vijaya Chitreddy, George Cotsarelis, Brittany Craiglow, Rachita Dhurat, Ncoza Dlova, Jeff DonovanBruna Duque-Estrada, Samantha Eisman, Abby Ellison, Paul Farrant, Juan Ferrando Barberá, Aida Gadzhigoroeva, Ramon Grimalt, Matthew Harries, Maria Hordinsky, Alan D. Irvine, Victoria Jolliffe, Leslie Jones, Brett King, Won Soo Lee, Nino Lortkipanidze, Amy McMichael, Andrew Messenger, Paradi Mirmirani, Elise Olsen, Seth J. Orlow, Yuliya Ovcharenko, Bianca Maria Piraccini, Rodrigo Pirmez, Adriana Rakowska, Pascal Reygagne, Melissa Riley, Lidia Rudnicka, David Saceda Corralo, Jerry Shapiro, Pooja Sharma, Tatiana Silyuk, Spartak Kaiumov, Desmond J. Tobin, Antonella Tosti, Sergio Vañó-Galván, Annika Vogt, Martin Wade, Leona Yip, Abraham Zlotogorski, Cheng Zhou, Rodney Sinclair

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Importance: A recent expert consensus exercise emphasized the importance of developing a global network of patient registries for alopecia areata to redress the paucity of comparable, real-world data regarding the effectiveness and safety of existing and emerging therapies for alopecia areata. Objective: To generate core domains and domain items for a global network of alopecia areata patient registries. Evidence Review: Sixty-six participants, representing physicians, patient organizations, scientists, the pharmaceutical industry, and pharmacoeconomic experts, participated in a 3-round eDelphi process, culminating in a face-to-face meeting at the World Congress of Dermatology, Milan, Italy, June 14, 2019. Findings: Ninety-two core data items, across 25 domains, achieved consensus agreement. Twenty further noncore items were retained to facilitate data harmonization in centers that wish to record them. Broad representation across multiple stakeholder groups was sought; however, the opinion of physicians was overrepresented. Conclusions and Relevance: This study identifies the domains and domain items required to develop a global network of alopecia areata registries. These domains will facilitate a standardized approach that will enable the recording of a comprehensive, comparable data set required to oversee the introduction of new therapies and harness real-world evidence from existing therapies at a time when the alopecia areata treatment paradigm is being radically and positively disrupted. Reuse of similar, existing frameworks in atopic dermatitis, produced by the Treatment of Atopic Eczema (TREAT) Registry Taskforce, increases the potential to reuse existing resources, creates opportunities for comparison of data across dermatology subspecialty disease areas, and supports the concept of data harmonization..

Original languageEnglish (US)
Pages (from-to)439-448
Number of pages11
JournalJAMA Dermatology
Volume157
Issue number4
DOIs
StatePublished - Apr 2021

Bibliographical note

Funding Information:
Funding/Support: This study was supported by the Australasian Hair and Wool Research Society of which Drs Sinclair, Jones, and Eisman are committee members; NISR Solutions, a charitable organization established with charitable funding from the City of Dublin Skin and Cancer Hospital, of which Dr Irvine is the chairman of the board of directors and Dr Wall is a consultant; grant EXC2151–390873048 from the Deutsche Forschungsgemeinschaft (German Research Foundation) under the auspices of the Germany Excellence Strategy (Dr Betz); and the NIHR Manchester Biomedical Research Centre (Dr Harries).

Funding Information:
receiving honoraria from Janssen Global Services, LLC, consultancy fees from Eli Lilly and Company, travel fees and grant support from Pfizer, Inc, and personal fees for consultancy from the not-for-profit company, National and International Skin Registry (NISR) Solutions. Dr Blume-Peytavi reported receiving honoraria and consultancies from AbbVie, Bayer AG, Galderma, Pfizer, Inc, Pierre Fabre Group, Sanofi, and Regeneron Pharmaceuticals Inc unrelated to the present study. Dr Callender reported serving as principal investigator in a clinical trial for Eli Lilly and Company for which she received a clinical research grant. Ms Campbell reported serving as the president of the Australia Alopecia Areata Foundation Inc. Ms Chambers and Alopecia UK have received funds from Pfizer, Inc, to cover costs for public and patient involvement and from Concert Pharmaceuticals in the form of event sponsorship. Dr Cotsarelis reported serving as a coinvestigator on a trial sponsored by Eli Lilly and Company. Dr Craiglow reported receiving honoraria and/or fees from Aclaris Therapeutics, Inc, Arena Pharmaceuticals, Inc, Pfizer, Inc, Regeneron Pharmaceuticals Inc, and Sanofi-Genzyme. Dr Eisman reported serving as principal investigator in clinical trials for Pfizer, Inc, AbbVie, Arena Pharmaceuticals, Inc, Boston Pharmaceuticals, Bristol Myers Squibb, Botanix Pharmaceuticals, Dermira, Inc, Eli Lilly and Company, LEO Pharma, Novartis Pharmaceuticals Corporation, and Regeneron Pharmaceuticals Inc. Dr Farrant reported serving as principal investigator in clinical trials for Pfizer, Inc, and AbbVie and consulting for Eli Lilly and Company. Dr Gadzhigoroeva reported serving as an author for speaker bureaus of Pfizer, Inc. Dr Hordinsky reported serving as an investigator for alopecia areata clinical trials sponsored by Pfizer, Inc, and Eli Lilly and Company examining the safety and efficacy of JAK inhibitors for alopecia areata. Dr Irvine reported receiving honoraria and consultancies from Pfizer, Inc, Novartis Pharmaceuticals Corporation, AbbVie, Sanofi, and Regeneron Pharmaceuticals Inc unrelated to the present study and serving as the chairman of the charity NISR Solutions. Dr Jones reported serving as the secretary of the Australasian Hair and Wool Research Society. Dr King reported serving as an investigator for Concert Pharmaceuticals, Eli Lilly and Company, and Pfizer, Inc; consulting for and/or serving on advisory boards for Aclaris Therapeutics, Inc, Arena Pharmaceuticals, Inc, Bristol Meyers Squibb, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly and Company, and Pfizer, Inc; and serving on the speaker’s bureau for Pfizer, Inc, Pharmaceuticals Inc, and Sanofi-Genzyme. Dr McMichael reported receiving personal fees for consultancy work with Bioniz, Pfizer, Inc, and Revian, Inc, and personal fees and grants from Aclaris Therapeutics, Inc, Concert Pharmaceuticals, Galderma, Allergan, Almirall, SA, Cassiopea, Inc, Incyte, Procter and Gamble, and Revian, Inc. Dr Messenger reported consulting for Pfizer, Inc, and Manentia. Dr Mirmirani reported serving as an investigator for Concert Pharmaceuticals, Pfizer, Inc, and Eli Lilly and Company. Dr Olsen reported serving as an investigator for Aclaris Therapeutics, Inc, and consulting for Arena Pharmaceuticals, Inc. Dr Piraccini reported receiving consultancy fees from Pierre Fabre Group–Ducray, ISDIN, Giuliani, Avangarde, Legacy Healthcare, Pfizer, Inc, and Almirall, SA. Dr Pirmez reported receiving consulting fees from Aché, honoraria from Pierre Fabre do Brasil, and lecture fees from L’Oréal and USK. Dr Rudnicka reported serving as an expert consultant for Pfizer, Inc, LEO Pharma, Jannsen Global Services, LLC, L’Oréal, Pierre Fabre Group, Novartis Pharmaceuticals Corporation, Eli Lilly and Company, and Medac GmbH. Dr Shapiro reported serving as a consultant and investigator for Pfizer, Inc, consulting for Eli Lilly and Company, and receiving honoraria from Pfizer, Inc, and Eli Lilly and Company. Dr Tosti reported consulting for DS Healthcare Group Inc, Monat Global Corp, Almirall, SA, Thirty Madison, Eli Lilly and Company, LEO Pharma, Bristol Myers Squibb, and Procter and Gamble. Dr Vañó-Galván reported receiving consultancy fees from Pfizer, Inc, Almirall, SA, Cantabria Labs, ISDIN, Janssen Global Services, LLC, Pierre Fabre Group, L’Oreal, and Novartis Pharmaceuticals Corporation. Dr Sinclair reported serving as a consultant or paid speaker for or participating in clinical trials sponsored by LEO Pharma, Amgen, Inc, Novartis Pharmaceuticals Corporation, Merck & Co, Celgene Corporation, Coherus BioSciences, Janssen Global Services, LLC, Regeneron Pharmaceuticals Inc, MedImmune, LLC, GlaxoSmithKline, Cutanea, Samson Clinical, Boehringer Ingelheim, Pfizer, Inc, Merck Sharp & Dohme, Oncobiologics, Inc, F. Hoffman–La Roche, Ltd, Eli Lilly and Company, and Bayer AG and serving as the current President of the Australasian Hair and Wool Research Society. No other disclosures were reported.

Publisher Copyright:
© 2021 American Medical Association. All rights reserved.

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