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Br J Dermatol. 2016 Jul;175(1):69-79. doi: 10.1111/bjd.14773. Epub 2016 Jul 19.

Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).

Author information

  • 1Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.
  • 2Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A.
  • 3Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
  • 4Lund University, Skåne University Hospital, Department of Dermatology, Malmö, Sweden.
  • 5Department of Public Health Sciences, Karlstad University, Karlstad, Sweden.
  • 6Centre for Evidence-Based Healthcare, University of Dresden, Dresden, Germany.
  • 7Department of Occupational and Social Medicine, Technical University Dresden, Dresden, Germany.
  • 8Medicine Service, Birmingham VA Medical Center, Birmingham, AL, U.S.A.
  • 9Department of Medicine, University of Alabama, Birmingham, AL, U.S.A.
  • 10Department of Dermatology and Venereology, Malmö University Hospital, Malmö, Sweden.
  • 11Department of Dermatology, University of California San Francisco, San Francisco, California, CA, U.S.A.
  • 12Department of Dermatology, University of São Paulo Medical School, São Paulo, Brazil.
  • 13Immunology and Inflammation, Regeneron Pharmaceuticals, Inc., New York, NY, U.S.A.
  • 14Psoriasis and Eczema Association of Norway, Oslo, Norway.
  • 15Department of Dermatology, CHU de Nantes, Nantes, France.
  • 16Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
  • 17Department of Dermatology, Oslo University Hospital, Oslo, Norway.
  • 18National Eczema Organisation, National Eczema Association, San Rafael, CA, U.S.A.
  • 19Chugai Pharma Europe Ltd., London, U.K.
  • 20No affiliation (patient representative U.K.).
  • 21Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
  • 22Société Canadienne de l'Eczéma, Keswick, ON, Canada.
  • 23LEO Pharma A/S, Industriparken 55, Ballerup, Denmark.
  • 24Division of Dermatology, University Health Network, Toronto, ON, Canada.
  • 25Health Economics and Outcomes Research, Sanofi, France.
  • 26St John's Institute of Dermatology, Guy's and St Thomas' Hospitals NHS Foundation Trust and King's College London, London, U.K.
  • 27LEO Pharma, Copenhagen, Denmark.
  • 28Department of Dermatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
  • 29National Eczema Society, London, U.K.
  • 30Brazilian Atopic Dermatitis Association (AADA), São Paulo, Brazil.
  • 31Osaka Prefectural Medical Center for Respiratory and Allergic Disease, Osaka, Japan.
  • 32No affiliation (patient representative Sweden).
  • 33Sanofi-Aventis, Paris, France.
  • 34Association Française de l'Eczéma, Redon, France.
  • 35Mie University, Graduate School of Medicine and Mie University Hospital Tsu, Mie, Japan.
  • 36Department of Dermatology, Osaka University, Osaka, Japan.
  • 37Department of Dermatology, St George Hospital, Sydney, Australia.
  • 38University of New South Wales, Sydney, Australia.
  • 39Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
  • 40Retired, no affiliation.
  • 41Celgene Corporation, Greater New York City Area Pharmaceuticals, New York, NY, U.S.A.
  • 42Division of Allergy, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
  • 43Ostermed Ltd., Kent, U.K.
  • 44Celgene BV, Utrecht, the Netherlands.
  • 45Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands.
  • 46Ziarco Pharma Ltd, Kent, U.K.
  • 47School of Social & Community Medicine, University of Bristol, Bristol, U.K.
  • 48Health Economics Group, University of East Anglia, Norwich, U.K.
  • 49Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • 50Sanofi-Aventis, Montpellier, France.
  • 51Toulouse University, Toulouse, France.
  • 52Department of Dermatology, University of Tartu, Tartu, Estonia.
  • 53Dermatology Unit, Department of Medicine, Karolinska Institutet, Solna, Sweden.
  • 54Karolinska University Hospital, Stockholm, Sweden.
  • 55Department of Dermatology, Venereology and Allergy University Hospital Schleswig-Holstein, Kiel, Germany.
  • 56Occupational and Environmental Dermatology, Department of Social Medicine, University of Heidelberg, Heidelberg, Germany.
  • 57Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.

Abstract

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure (POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms.

PMID:
27436240
DOI:
10.1111/bjd.14773
[PubMed - in process]
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