Schmitt 2014 — HOME IV: EASI as core instrument for clinical signs of atopic eczema
Citation
Schmitt J, Spuls PI, Thomas KS, Simpson E, Furue M, Deckert S, et al.; HOME Initiative. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol. 2014 Oct;134(4):800–807. DOI: 10.1016/j.jaci.2014.07.043. PMID 25282560.
Study design and population
International multi-stakeholder consensus (HOME IV). Combined systematic review of 16 AD severity instruments + Delphi + nominal group with patients, clinicians, methodologists, regulators and industry.
Reported outcomes
- Consensus: EASI recommended as the single core instrument for clinical signs in all future AD trials
- Rationale: EASI showed adequate validity, responsiveness, internal consistency and intra-observer reliability across systematic-review evidence; of 16 instruments, only EASI and objective SCORAD met adequate validation across measurement properties
- Paired with POEM for patient-reported symptoms; DLQI/CDLQI/IDQoLI for HRQoL; RECAP/ADCT for long-term control (subsequent HOME core-outcome-set statements)
Surrogate-to-outcome linkage
Codifies EASI as the accepted regulatory / consensus severity surrogate for atopic dermatitis, paired with POEM / DLQI for patient-relevant outcomes. Formally anchors the severity-score → patient-outcome linkage used in dupilumab (Simpson 2016), upadacitinib and tralokinumab pivotal trials.
CRIT1–7 appraisal
| Criterion | Score | Justification |
|---|---|---|
| CRIT1 Relevance | 3 | Direct — EASI is the canonical AD severity surrogate. |
| CRIT2 Methodology | 3 | Systematic review + international Delphi + nominal group with regulator participation. |
| CRIT3 Reporting | 3 | Clear consensus statement with voting percentages. |
| CRIT4 Applicability | 3 | International, regulator-informed; directly applicable. |
| CRIT5 Evidence weight | 3 | International consensus statement (HOME) with systematic-review backing. |
| CRIT6 Risk of bias | 2 | Participant-selection bias; limited low-resource representation. |
| CRIT7 Contribution | 3 | Core anchor — regulator-recognised endpoint codification. |
Aggregate: very strong.
Limitations and notes
Participant-selection and industry-participation bias typical of consensus documents; voting percentages rather than effect sizes.
Strength as anchor
Very strong for the accepted-surrogate claim in the AD strand of the severity-scoring argument. Complements EMA 2004 (psoriasis strand), Olsen 2004 (AA / SALT strand) and Doshi 1997 / FDA acne guidance (acne strand).