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Core Outcomes for eczema trials

The four core outcome domains that should be measured and reported in ALL eczema trials are:

  1. Clinician-reported signs
  2. Patient-reported symptoms
  3. Quality of Life
  4. Long-term control

All trials should measure the core domains and measure these using core outcome instruments (where available) as this will enable trials to be compared and combined in meta-analyses. However, the inclusion of core outcomes does not preclude the use of any additional domains, scales or instruments.

Clinical Signs - EASI

EASI
For clinical signs

 Consensus Statement: Schmitt et al. 2014

Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema.

Patient-Reported Symptoms - POEM

POEM for patient-reported symptoms 

NRS 11 for intensity of itch

 Consensus Statement for POEM:  Spuls et al. 2017

Patient Oriented Eczema Measure (POEM) is a validated instrument that measures the illness as experienced by the patient. 

Numerical Rating Scale (NRS) 11 point for worst itch over the last 24 hours (Yosipovitch 2019

 

Quality of Life

DLQI (adults), CDLQI (children), IDQoL (infants) for quality of life

 DLQI (adults), CDLQI (children), IDQoL (infants) were recommended for the COS at the recent HOME VII meeting for measuring qualty of life.

Long-Term Control

Recap of atopic eczema (RECAP) or the Atopic dermatitis control test (ADCT) for long-term control

 RECAP* and the ADCT* were recommended for the COS at the recent HOME VII. These instruments will be published in due course and made available via the HOME website.

 


HOME - Harmonising Outcome Measures for Eczema

Centre of Evidence Based Dermatology
University of Nottingham
King's Meadow Campus
Lenton Lane, Nottingham
NG7 2NR, UK

Telephone: +44 115 8232435
Fax: +44 115 8468618
Email: HOME@nottingham.ac.uk