The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials

Jochen Schmitt, Phyllis I. Spuls, Kim S. Thomas, Eric Simpson, Masutaka Furue, Stefanie Deckert, Magdalene Dohil, Christian Apfelbacher, Jasvinder A. Singh, Joanne Chalmers, Hywel C. Williams

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care.

Original languageEnglish (US)
Pages (from-to)800-807
Number of pages8
JournalJournal of Allergy and Clinical Immunology
Volume134
Issue number4
DOIs
StatePublished - Oct 1 2014

Fingerprint

Eczema
Atopic Dermatitis
Outcome Assessment (Health Care)
Consensus
Drug Industry
Signs and Symptoms
Decision Making
Patient Care
Nurses
Communication
Quality of Life
Clinical Trials
Physicians

Keywords

  • Atopic dermatitis
  • clinical trials
  • eczema
  • Eczema Area and Severity Index
  • evidence-based medicine
  • outcomes research

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Medicine(all)

Cite this

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. / Schmitt, Jochen; Spuls, Phyllis I.; Thomas, Kim S.; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A.; Chalmers, Joanne; Williams, Hywel C.

In: Journal of Allergy and Clinical Immunology, Vol. 134, No. 4, 01.10.2014, p. 800-807.

Research output: Contribution to journalArticle

Schmitt, J, Spuls, PI, Thomas, KS, Simpson, E, Furue, M, Deckert, S, Dohil, M, Apfelbacher, C, Singh, JA, Chalmers, J & Williams, HC 2014, 'The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials', Journal of Allergy and Clinical Immunology, vol. 134, no. 4, pp. 800-807. https://doi.org/10.1016/j.jaci.2014.07.043
Schmitt, Jochen ; Spuls, Phyllis I. ; Thomas, Kim S. ; Simpson, Eric ; Furue, Masutaka ; Deckert, Stefanie ; Dohil, Magdalene ; Apfelbacher, Christian ; Singh, Jasvinder A. ; Chalmers, Joanne ; Williams, Hywel C. / The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. In: Journal of Allergy and Clinical Immunology. 2014 ; Vol. 134, No. 4. pp. 800-807.
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