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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries

Authors: Louise A. A. Gerbens, Aaron E. Boyce, Dmitri Wall, Sebastien Barbarot, Richard J. de Booij, Mette Deleuran, Maritza A. Middelkamp-Hup, Amanda Roberts, Christian Vestergaard, Stephan Weidinger, Christian J. Apfelbacher, Alan D. Irvine, Jochen Schmitt, Paula R. Williamson, Phyllis I. Spuls, Carsten Flohr

Published in: Trials | Issue 1/2017

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Abstract

Background

Patients 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/design

Participants 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.

Discussion

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.

Trial registration

Not applicable. This eDelphi study was registered in the Core Outcome Measures for Effectiveness Trials (COMET) database.
Appendix
Available only for authorised users
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Metadata
Title
TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries
Authors
Louise A. A. Gerbens
Aaron E. Boyce
Dmitri Wall
Sebastien Barbarot
Richard J. de Booij
Mette Deleuran
Maritza A. Middelkamp-Hup
Amanda Roberts
Christian Vestergaard
Stephan Weidinger
Christian J. Apfelbacher
Alan D. Irvine
Jochen Schmitt
Paula R. Williamson
Phyllis I. Spuls
Carsten Flohr
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1765-7

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