Core Outcome Measures in Effectiveness Trials

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

General Information

Summary:
Atopic eczema (AE) is one of the most common inflammatory skin disorders with a major impact on health-related quality of life. Moderate-to-severe patients require photo- or systemic immunomodulatory therapies to induce disease remission and long-term control. The current evidence to inform clinical management stems from a small body of clinical trials and observational studies, despite the frequent and often off-label use of these treatment modalities. The establishment of national registries that use the same methodology would not only fill the gaps in the current evidence, but could also operate as a research platform to inform the design of future RCTs and basic research.
Using an e-Delphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce therefore seeks to find consensus between key stakeholders internationally on a minimum set of domains and domain items to inform the design of existing and future AE research registries that collect real world data of children and adults on photo- and systemic immunomodulatory therapies.

Protocol link: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1765-7

Contributors:
Project Leads:
L.A.A. Gerbens, MD PhD student, Academic Medical Centre Amsterdam (NL)
C. Flohr, MD PhD, St John’s Institute of Dermatology, Guy’s & St Thomas’ NHS Foundation Trust and King’s College London (UK) (PI)
Ph.I. Spuls, MD PhD, Academic Medical Centre Amsterdam (NL) (PI)

Project Steering Group:
C. Apfelbacher, PhD, University of Regensburg (DE)
S. Barbarot, MD PhD, Nantes University Hospital (FR)
A. Boyce, MD, St John’s Institute of Dermatology, Guy’s & St Thomas’ NHS Foundation Trust London (UK)
M. Deleuran, MD PhD, Aarhus University Hospital (DK)A. Irvine, MD PhD, St James’s Hospital Dublin (IE)
M.A. Middelkamp-Hup, MD PhD, Academic Medical Centre Amsterdam (NL)
J. Schmitt, MD MPH, Medical Faculty Carl Gustav Carus, TU Dresden (GE)
C. Vestergaard, MD PhD, Aarhus University Hospital (DK)
D. Wall, MD PhD, candidate, St James’s Hospital Dublin (IE)
S. Weidinger, MD MaHM, University Hospital Schleswig-Holstein, Kiel (GE)
P.R. Williamson, PhD, University of Liverpool and COMET Initiative (UK)

Further Study Information

Current Stage:
Ongoing
Date:
November 2015 - May 2016
Funding source(s):
Unconditional grant held by CF, Unit for Population-Based Dermatology Research, St John’s Institute of Dermatology, King’s College London, London, UK Irish Skin Foundation (ISF)

Health Area

Disease Category
Skin

Disease Name
Eczema

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Drug
Phototherapy

Method(s)

Consensus meeting
Delphi process
Literature review

A list of key domains and domain items will be identified by review within the TREAT research group. All e-Delphi participants will be asked to add to this list in Round 1. Participants from six stakeholder groups are invited: doctors, nurses, non-clinical researchers, patients, industry representatives and regulatory body representatives. The e-Delphi comprises 3 sequential online rounds. Participants are asked to rate the importance of proposed domains and domain items. In Round 1, this is done independently, while in Round 2 the scores of others in the same stakeholder group and in Round 3 across all participants are visible, allowing participants to adjust their original score accordingly. A final consensus meeting will be held with representatives of each stakeholder group to iron out remaining areas of disagreement.
The eDelphi questionnaire will be distributed using an online e-management system maintained by the Core Outcome Measures for Effectiveness Trials Initiative (COMET) initiative. Consensus is reached if 70% or more of participants in each stakeholder group score the importance of the domain or domain item as 7 to 9 and less than 15% score it as 1 to 3.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Economists
Epidemiologists
Methodologists
Regulatory agency representatives
Researchers

Study Type

COS for registry

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