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Dr Matthew Ridd (Chief investigator/first author)

Comparison of patient (POEM), observer (EASI, SASSAD, TIS) and corneometry measures of emollient effectiveness in children with eczema: findings from the COMET feasibility trial.

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Dr Matthew Ridd (Chief investigator/first author)

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  1. Comparison of patient (POEM), observer (EASI, SASSAD, TIS) and corneometry measures of emollient effectiveness in children with eczema: findings from the COMET feasibility trial M.J. Ridd,1 D.M. Gaunt,2 R.H. Guy,3 N.M. Redmond,1,4 K. Garfield,2 S. Hollinghurst,1 N. Ball,1 L. Shaw,5 S. Purdy,1 C. Metcalfe2 1Centre for Academic Primary Care, University of Bristol 2Bristol Randomised Trials Collaboration, University of Bristol 3Department of Pharmacy & Pharmacology, University of Bath 4NIHR CLAHRC West, University Hospitals Bristol NHS Foundation Trust, Bristol. 5Department of Dermatology, University Hospitals Bristol NHS Foundation Trust British Journal of Dermatology. DOI: 10.111/bjd.16475

  2. Dr Matthew Ridd (Chief investigator/first author)

  3. Introduction: What’s already known? (1) • There are many different patient and observer-reported measures of eczema severity with different levels of evidence for the measurement properties for each instrument. The value of “objective” measures of skin hydration is also unclear.

  4. Introduction: What’s already known? (2) • POEM and EASI have been recommended by the Harmonising Outcome Measures for Eczema (HOME) initiative as core outcomes for all clinical eczema trials but they have not been widely used in community settings/populations with mild eczema.

  5. Objective • To compare the change in scores and correlations within and between five measures of eczema severity: • Patient Orientated Eczema Measure (POEM) • Eczema Area Severity Index (EASI) • Six Area Six Sign Atopic Dermatitis (SASSAD) • Three Item Severity (TIS), and • Skin hydration (corneometry).

  6. Methods (1) • Data from a feasibility trial that randomised young children with eczema to one of four emollients. • Participants were followed for three months (84 days) • Parent-completed diaries: Patient Orientated Eczema Measure – POEM (weekly), Parent Global Assessment – PGA (every 28 days) • Observer visits (every 28 days): • Eczema Area Severity Index (EASI), • Six Area, Six Sign Atopic Dermatitis (SASSAD) • Three Item Severity (TIS) • Skin hydration, assessed using a corneometer

  7. Methods (2) • Descriptive statistics (by emollient over time) and Spearman’s correlation coefficients comparing scores at each time-point and absolute change (between adjacent time-points) for each outcome measure.

  8. Results – Characteristics of participants at baseline

  9. Results –Total scores and change of scores

  10. Results – Comparison within measures Results –

  11. Results – Comparison of change between measures

  12. Discussion: Summary (1) • At baseline, the POEM and TIS measures captured a range of eczema severity but only POEM was shown to have a close approximation to normal distribution. • Mean POEM, EASI, SASSAD and TISS improved month-by-month, with POEM showing the greatest sensitivity to change (effect size 42%).

  13. Discussion: Summary (2) • Observer-administered measures (EASI, SASSAD and TIS) correlated mostly strongly. • Corneometry scores were more variable, correlated less well with itself over time, and were poorly correlated with the other measures.

  14. Discussion: Strengths and limitations (1) • First paper of its type to compare patient, observer and corneometry measures of eczema severity/skin hydration using a sizeable dataset collected from a community-based population. • Most participants in COMET were white and the measures may perform differently in children with darker skin.

  15. Discussion: Strengths and limitations (2) • Observed variability in corneometry readings may reflect time since bathing or application of emollient, or differences in the properties of the four emollients

  16. Discussion: Research and practice (1) • The findings study support the adoption by HOME of POEM and EASI as the core patient and observer (including clinician)-reported outcome instruments, respectively, for trials of eczema treatments. • Patient-reported and objective measures of eczema severity are not inter-changeable.

  17. Discussion: Research and practice (2) • The high variability in the corneometry readings and the low correlations with other measures, suggest it should not be used to determine the effectiveness of emollients, at least in community/pragmatic trial settings.

  18. Conclusions: What does this study add? (1) • In children with mostly mild-moderate eczema randomised to one of four emollients for 12 weeks, POEM, EASI, SASSAD and TIS all showed a reduction in eczema severity but skin hydration (corneometry) did not. • There was poor correlation between POEM and observer-reported measures; and poor correlation between all these measures and corneometry.

  19. Conclusions: What does this study add? (2) • The characteristics of POEM and EASI supports their recommendation by HOME as core outcomes in trials of eczema treatments.

  20. Research Team

  21. Call for correspondence • Why not join the debate on this article through our correspondence section? • Rapid responses should not exceed 350 words, four references and one figure • Further details can be found here

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