Core Outcome Domains for Eczema – Results of a
Delphi Consensus Project
+
HC
+
KS
Schmitt J*, Williams
& Thomas
on behalf of the
Harmonizing Outcome Measurements in Eczema (HOME) Delphi panel
* Medical Faculty, University of Dresden, Germany and + Centre of Evidence Based Dermatology, University of Nottingham
Introduction
Eczema is a chronic, relapsing, inflammatory skin
disorder that affects up to 20% or children and 3-5%
of adults.
Many trials of treatments for eczema are published
every year, but there is no consensus over the most
appropriate way of measuring treatment success,
and many different named (and unnamed) scales
are used.
Outcome domains considered
 Clinical signs assessed by physician
 Clinical signs assessed by patient
 Investigator global assessment
 Patient global assessment
Core sets of outcome measures are useful for
increasing clinical interpretability, preventing
selective reporting bias, limiting statistical errors by
reducing the number of variables to be analysed,
and enabling valid pooling of results across different
studies.
 Quality of life (general)
 Short-term control of flares
 Long-term control of flares
 Cost
 Extent of disease
 Involvement of high expression areas
The first step in identifying a core set of outcome
measures for use in eczema research is to establish
a core set of outcome domains. In order to do this,
we conducted an international Delphi consensus
project.
 The Delphi process is a useful consensus
method to define core sets of outcome domains.
 Involvement of patients in the process was a
key strength, but may have been limited by the
relatively small number of patients / carers
involved.
 Symptoms
 Quality of life (dermatology-specific)
Wide variation in the use of outcome measures for
assessing eczema, makes if difficult to combine trial
results by meta-analysis in systematic reviews.
Discussion
 This project represents the first step in trying to
identify a core set of outcome measures for
eczema research and management.
 A face-to-face consensus meeting is now
required to establish the best way of measuring
these outcome domains.
 Such a meeting was held in Amsterdam in June
2011, at which the three core domains were
confirmed and an additional domain for quality
of life was added.
 Treatment utilisation
Results
Aim
 Forty-six individuals from 11 countries (81% of
those invited) participated.
 To develop a consensus based set of core
outcome domains for eczema that can be used
for controlled clinical trials, and for clinical
recordkeeping.
 Overall, 6 consumer, 32 clinical experts, 1
regulatory agency representative and 7 journal
editors took part
Method
 Three-stage web-based international Delphi
consensus exercise conducted between June
2008 and March 2010.
 Participants: 57 individuals from four
stakeholder groups , and representing 13
different countries were included. These
consisted of:





Consumers
Clinical experts
Regulatory agency representatives
Journal editors.
All participants were asked to rate the
importance of 19 outcome domains for eczema
and to choose which domains should be
included in two core sets of outcomes:


 Of these, 100% (n = 46) and 93% (n = 43)
participated in the 2nd and 3rd rounds.
For use in clinical trials
For use in medical record keeping
 Consensus was achieved for inclusion of
symptoms, physician-assessed clinical signs,
and a measurement for long-term control of
flares in the core set of outcome domains for
eczema trials.
 For medical recordkeeping, consensus was
reached to regularly monitor eczema symptoms
in clinical practice.
 In contrast to clinical experts, journal editors
and the regulatory agency representative , the
majority of patients (67%) indicated that
dermatology-specific should not be included in
the core set.
 People with a specific interest in outcome
measurement (e.g. people who had developed
the scales) were not invited to participate.
 For further details about the progress of the
HOME initiative, please see :
www.homeforeczema.org
Conclusion
Preliminary consensus over a core set of
outcome domains has been reached.
Core outcomes for eczema trials include:
o
o
o
o
Core outcomes for medical recordkeeping:
o
 Participants received standardized feedback,
including the group median, inter-quartile range,
and previous responses, and the assessment
was repeated in two subsequent rounds.
 Consensus was defined a priori as at least 60%
of the members of at least three stakeholder
groups, including consumers, recommending
domain inclusion in the core set.
Eczema symptoms
Physician-assessed clinical signs
Long-term control of flares
Quality of Life
Eczema symptoms
Acknowledgements
Figure: The eczema severity scales Tower of Babel
This poster presents independent research
commissioned by the National Institute for Health
Research (NIHR) under its Programme Grants for
Applied Research funding scheme (RP-PG-040710177). The views expressed in this poster are
those of the author(s) and not necessarily those of
the NHS, the NIHR or the Department of Health.