Abstract
BackgroundPatients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. The current evidence to guide clinical management is small, despite the frequent and often off-label use of these treatments. Registries of patients on photo- and systemic immunomodulatory therapies could fill this gap, and the collection of a core set concerning these therapies in AE will allow direct comparisons across registries as well as data sharing and pooling.Using an eDelphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek consensus between key stakeholders internationally on a core set of domains and domain items for AE patient registries with a research focus that collect data of children and adults on photo- and systemic immunomodulatory therapies.Methods/designParticipants from six stakeholder groups will be invited: doctors, nurses, non-clinical researchers, patients, as well as industry and regulatory body representatives. The eDelphi will comprise three sequential online rounds, requesting participants to rate the importance of each proposed domain and domain items. Participants will be able to add domains and domain items to the proposed list in round 1. A final consensus meeting will be held with representatives of each stakeholder group.DiscussionIdentifying a uniform core set of domains and domain items to be captured by AE patient registries will increase the utility of individual registries, and provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies to guide clinical management across dermatology centres and country borders.Trial registrationNot applicable. This eDelphi study was registered in the Core Outcome Measures for Effectiveness Trials (COMET) database.
Highlights
Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control
Identifying a uniform core set of domains and domain items to be captured by AE patient registries will increase the utility of individual registries, and provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies to guide clinical management across dermatology centres and country borders
Novel agents are currently tested in clinical trials (e.g. dupilumab, lebrikizumab, apremilast, ustekinumab, and Chemoattractant receptor-homologous molecule expressed on Th2 cells (CRTH2) antagonist)
Summary
Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. Using an eDelphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek consensus between key stakeholders internationally on a core set of domains and domain items for AE patient registries with a research focus that collect data of children and adults on photo- and systemic immunomodulatory therapies. Whilst most patients with AE can be treated effectively with emollients and topical anti-inflammatory agents, a significant number will require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control [3]. The current evidence to guide clinical management for moderate-to-severe AE originates from a small body of randomised controlled trials (RCTs) [5] and observational studies [6,7,8]. Several scientific guidelines and a systematic review highlight these gaps [5, 9, 10] and lament the resulting lack of clear management guidance to inform clinical practice
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