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?
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.
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.
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.
To generate core domains and domain items for a global network of alopecia areata patient registries.
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.
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.
Wall D, Meah N, York K, et al. 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). JAMA Dermatol. 2021;157(4):439–448. doi:10.1001/jamadermatol.2020.5839
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