TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo‐ and systemic therapy registries. (3rd August 2018)

• Record Type: Journal Article
• Authors: Gerbens, L.A.A.; Apfelbacher, C.J.; Irvine, A.D.; Barbarot, S.; de Booij, R.J.; Boyce, A.E.; Deleuran, M.; Eichenfield, L.F.; Hof, M.H.; Middelkamp‐Hup, M.A.; Roberts, A.; Schmitt, J.; Vestergaard, C.; Wall, D.; Weidinger, S.; Williamson, P.R.; Flohr, C.; Spuls, P.I.
• Is Part Of: British journal of dermatology. Volume 180:Number 4(2019)
• Page Start: 790
• Page End: 801
• Publication Date: 2018-08-03
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.16714
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Evidence of immunomodulatory therapies to guide clinical management of atopic eczema (AE) is scarce, despite frequent and often off‐label use. Patient registries provide valuable evidence for the effects of treatments under real‐world conditions that can inform treatment guidelines, give the opportunity for health economic evaluation and the evaluation of quality of care, as well as pharmacogenetic and dynamic research, which cannot be adequately addressed in clinical trials. Objectives: The TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek international consensus on a core set of domains and items ('what to measure') for AE research registries, using a Delphi approach. Methods: Participants from six stakeholder groups were included: doctors, nurses, nonclinical researchers, patients, industry and regulatory body representatives. The eDelphi comprised three sequential online rounds, requesting participants to rate the importance of each proposed domain item. Participants could add domain items to the proposed list in round 1. A final consensus meeting was held to ratify the core set. Results: Participants ( n = 479) from 36 countries accessed the eDelphi platform, of whom 86%, 79% and 74% completed rounds 1, 2 and 3, respectively. At the face‐to‐face consensus meeting attended by 42 participants the final core set was established containing 19 domains with 69 domain items (49 baseline and 20 follow‐up items). Conclusions: This core set of domains and items to be captured by national AE systemic therapy registries will standardize data collection and thereby allow direct comparability across registries and facilitate data pooling between countries. Ultimately, it will provide greater insight into the effectiveness, safety and cost‐effectiveness of photo‐ and systemic immunomodulatory therapies. Abstract : What's already known about this topic? Evidence of photo‐ and systemic immunomodulatory therapies to guide clinical management for atopic eczema (AE) is scarce, despite frequent and often off‐label use. There is a need to gather long‐term, comparative and real‐life data on the effectiveness, safety and cost‐effectiveness of these therapies beyond the confines of short‐term randomized controlled trials, especially when new biological and small‐molecule therapies are entering clinical practice. Patient registries can provide valuable data to address these issues. What does this study add? By performing an international Delphi exercise, consensus was reached on a core set of domains and items to be captured by national AE patient registries. This core set will standardize data collection and thereby allow direct comparability across registries and facilitate data pooling between countries. What are the clinical implications of this work? Ultimately, this core set will provide greater insight into the effectiveness, safety and cost‐effectiveness of photo‐ and systemic immunomodulatory therapies. This may fill the current gaps of evidence and lead to new guidelines for daily clinical practice, and thereby may contribute to the improvement of the care of children and adults with AE. Respond to this article Plain language summary available online