Core Outcome Domains for Eczema

1
Core Outcome Domains for Eczema Results of a
Delphi Consensus Project
Schmitt J, Williams HC Thomas KS 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. Wide variation in the use of outcome
measures for assessing eczema, makes if difficult
to combine trial results by meta-analysis in
systematic reviews. 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. 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.

• Discussion
• 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.
• 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.

Outcome domains considered
Clinical signs assessed by physician
Clinical signs assessed by patient
Investigator global assessment
Patient global assessment
Symptoms
Quality of life (dermatology-specific)
Quality of life (general)
Short-term control of flares
Long-term control of flares
Cost
Extent of disease
Involvement of high expression areas
Treatment utilisation

• Results
• Forty-six individuals from 11 countries (81 of
  those invited) participated.
• Of these, 100 (n 46) and 93 (n 43)
  participated in the 2nd and 3rd rounds.
• Overall, 6 consumer, 32 clinical experts, 1
  regulatory agency representative and 7 journal
  editors took part
• 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.

• Aim
• To develop a consensus based set of core outcome
  domains for eczema that can be used for
  controlled clinical trials, and for clinical
  recordkeeping.

• 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
• For use in clinical trials
• For use in medical record keeping
• 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.

• Conclusion
• Preliminary consensus over a core set of outcome
  domains has been reached.
• Core outcomes for eczema trials include
• Eczema symptoms
• Physician-assessed clinical signs
• Long-term control of flares
• Quality of Life
• Core outcomes for medical record-keeping
• Eczema symptoms

Acknowledgements 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-0407-10177). 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.
Figure The eczema severity scales Tower of Babel