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Consensus Statement
March 3, 2021

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, MBBCh, BAO, MSc Health Informatics1,2,3; Nekma Meah, MBChB3; Katherine York, MBBCh4; et al Bevin Bhoyrul, MBBS3; Laita Bokhari, MPhil Med3; Leonardo Spagnol Abraham, MD5; Roisín Adams, MPharm, MSc, PhD6; Wilma Bergfeld, MD7; Regina C. Betz, MD8; Ulrike Blume-Peytavi, MD9; Valerie Callender, MD10; Chel Campbell11; Jen Chambers12; Gang Chen, MB, MSc, PhD13; Vijaya Chitreddy, MBBS3; George Cotsarelis, MD14; Brittany Craiglow, MD15,16; Rachita Dhurat, MBBS, MD17; Ncoza Dlova, MBChB, PhD18,19; Jeff Donovan, MD, PhD20,21; Bruna Duque-Estrada, MD22; Samantha Eisman, MBChB3; Abby Ellison23; Paul Farrant, MBBS, BSc24; Juan Ferrando Barberá, MD25; Aida Gadzhigoroeva, MD, PhD26; Ramon Grimalt, MD, PhD27; Matthew Harries, MBCh, PhD28,29; Maria Hordinsky, MD30; Alan D. Irvine, MD, DSc31; Victoria Jolliffe, MA (Cantab)32; Leslie Jones, MSc, PhD3; Brett King, MD, PhD33; Won-Soo Lee, MD, PhD34; Nino Lortkipanidze, MD, PhD35; Amy McMichael, MD36; Andrew Messenger, MD37; Paradi Mirmirani, MD38; Elise Olsen, MD39; Seth J. Orlow, MD, PhD40,41; Yuliya Ovcharenko, MD, PhD42; Bianca Maria Piraccini, MD, PhD43; Rodrigo Pirmez, MD44; Adriana Rakowska, MD, PhD45; Pascal Reygagne, MD46; Melissa Riley47; Lidia Rudnicka, MD, PhD45; David Saceda Corralo, MD, PhD48; Jerry Shapiro, MD49; Pooja Sharma, MBBS3; Tatiana Silyuk, MD50; Spartak Kaiumov, MD, PhD51; Desmond J. Tobin, PhD52; Antonella Tosti, MD53; Sergio Vañó-Galván, MD, PhD48,54; Annika Vogt, MD9; Martin Wade, BMed Sci, MB, BS55; Leona Yip, MBChB, PhD56; Abraham Zlotogorski, MD57; Cheng Zhou, MD58; Rodney Sinclair, MBBS, MD3
Author Affiliations
  • 1Hair Restoration Blackrock, Dublin, Ireland
  • 2National and International Skin Registry Solutions (NISR), Charles Institute of Dermatology, University College Dublin, Dublin, Ireland
  • 3Sinclair Dermatology, Melbourne, Australia
  • 4Netcare Greenacres Hospital, Port Elizabeth, South Africa
  • 5Department of Dermatology, Hospital Regional da Asa Norte, Brasilia, Brazil
  • 6National Centre for Pharmacoeconomics, St James Hospital, Dublin, Ireland
  • 7Cleveland Clinic Main Campus, Cleveland, Ohio
  • 8Institute of Human Genetics, University of Bonn, School of Medicine and University Hospital Bonn, Bonn, Germany
  • 9Department of Dermatology, Venerology and Allergology, Clinical Research Center for Hair and Skin Science, Charité-Universitaetsmedizin Berlin, Berlin, Germany
  • 10Callender Dermatology and Cosmetic Center, Glenn Dale, Maryland
  • 11Australia Alopecia Areata Foundation Inc, Frankston, Australia
  • 12Alopecia UK, Shipley, United Kingdom
  • 13Centre for Health Economics, Monash University, Melbourne, Australia
  • 14Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia
  • 15Dermatology Physicians of Connecticut, Fairfield
  • 16Department of Dermatology, Yale University, New Haven, Connecticut
  • 17Department of Dermatology, LTM Medical College and Hospital Sion, Mumbai, India
  • 18Department of Dermatology, Nelson R Mandela School of Medicine, Durban, South Africa
  • 19School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa
  • 20Department of Dermatology, University of British Columbia, Vancouver, British Columbia, Canada
  • 21Donovan Hair Clinic, Whistler, British Columbia, Canada
  • 22Instituto de Dermatologia Prof Rubem David Azulay, Rio de Janeiro, Brazil
  • 23National Alopecia Areata Foundation, San Rafael, California
  • 24Brighton and Sussex University Hospitals NHS (National Health Service) Trust, Brighton, United Kingdom
  • 25Instituto Clínic de Medicina y Dermatología, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
  • 26Scientific and Practical Center Dermatolovenereology and Cosmetology of the Moscow City Health Department, Moscow, Russian Federation
  • 27Facultat de Medicina i Ciències de la Salut, Universitat Internacional de Catalunya, Barcelona, Spain
  • 28Centre for Dermatology Research, University of Manchester, Manchester Academic Health Science Centre and National Institute for Health Research Manchester Biomedical Research Centre, Manchester, United Kingdom
  • 29The Dermatology Centre, Salford Royal NHS Foundation Trust, Salford, Manchester, United Kingdom
  • 30Department of Dermatology, University of Minnesota, Minneapolis
  • 31Clinical Medicine, Trinity College Dublin, Dublin, Ireland
  • 32Centre for Cell Biology and Cutaneous Research, Blizard Institute, London, United Kingdom
  • 33Yale School of Medicine, New Haven, Connecticut
  • 34Department of Dermatology, Yonsei Wonju University, Wonju, Korea
  • 35Department of Dermatology and Venereology, David Tvildiani Medical University, Tbilisi, Republic of Georgia
  • 36Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina
  • 37Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom
  • 38Department of Dermatology, Kaiser Permanente Vallejo, Vallejo, California
  • 39Duke Dermatology Clinic, Durham, North Carolina
  • 40The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, New York
  • 41Department of Pediatrics, New York University Medical Center, New York, New York
  • 42Department of General and Clinical Immunology and Allergology, V. N. Karazin Kharkiv National University, Kharkiv, Ukraine
  • 43Department of Experimental, Diagnostic and Specialty Medicine, Alma Mater Studiorum University of Bologna, Bologna, Italy
  • 44Instituto de Dermatologia Professor Rubem David Azulay, Santa Casa da Misericórdia do Rio de Janeiro, Rio de Janeiro, Brazil
  • 45Department of Dermatology, Medical University of Warsaw, Warsaw, Poland
  • 46Centre de Santé Sabouraud, Hopital Saint Louis, Vellefaux, Paris, France
  • 47Canadian Alopecia Areata Foundation, King City, Ontario, Canada
  • 48Dermatology Department, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de Alcalá, Madrid, Spain
  • 49Disorders of the Hair and Scalp, The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, New York
  • 50Hair Treatment and Transplantation Center, Saint Petersburg, Russian Federation
  • 51Nautilus Clinic and Education Centre, St Petersburg, Russia
  • 52The Charles Institute of Dermatology, School of Medicine, University College Dublin, Belfield, Dublin, Ireland
  • 53Dr Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami, Miller School of Medicine, Miami, Florida
  • 54Trichology Unit, #TricoHRC Research Group, Madrid, Spain
  • 55The London Skin and Hair Clinic, London, United Kingdom
  • 56Skin Partners Specialist Dermatologists, Brisbane, Australia
  • 57Department of Dermatology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel
  • 58Department of Dermatology, Peking University People’s Hospital, Beijing, China
JAMA Dermatol. Published online March 3, 2021. doi:10.1001/jamadermatol.2020.5839
Key Points

Question  What data that should be captured by a global network of alopecia areata patient registries to describe the safety and effectiveness of existing and emerging therapies?

Findings  This review included 66 expert physicians, patient organizations, scientists, representatives of the pharmaceutical industry, and pharmacoeconomic experts, who identified 92 core and 20 noncore data items in a 3-round eDelphi process.

Meaning  The identified data items provide a blueprint for the development of a global network of alopecia areata patient registries capable of addressing a real-world evidence gap regarding alopecia areata therapeutics and outcomes.

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.

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