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Core Outcomes for 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 sysmptoms and NRS 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 tool (ADCT) for long-term control

RECAP* and the ADCT* were recommended for the COS at the recent HOME VII.

 

For more details on how to use the Core Outcome Set, read our users' guide.

When referencing the Core Outcome Set, please cite this paper:

The HOME core outcome set for clinical trials of atopic dermatitis

Hywel C Williams, Jochen Schmitt, Kim S Thomas, Phyllis Spuls, Eric L Simpson, Christian J Apfelbacher, Joanne R Chalmers, Masutaka Furue, Norito Katoh, Louise A Gerbens, Yael A Leshem, Laura Howells, Jasvinder A Singh, Maarten Boars, HOME initiative.  J Allergy Clin Immunol. 2022 Jun;149(6):1899-1911.doi: 10.1016\j.jaci.2022.03.017 EPub 2022 Mar 26 Use the COS

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