title: Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).
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.
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.
authors.forename: J R
authors.initials: JR
authors.lastname: Chalmers
authors.affiliation: Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A.
authors.forename: E
authors.initials: E
authors.lastname: Simpson
authors.affiliation: Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
authors.forename: C J
authors.initials: CJ
authors.lastname: Apfelbacher
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.
authors.forename: K S
authors.identifier: http://orcid.org/0000-0001-7785-7465
authors.initials: KS
authors.lastname: Thomas
authors.affiliation: Lund University, Skåne University Hospital, Department of Dermatology, Malmö, Sweden.|Department of Public Health Sciences, Karlstad University, Karlstad, Sweden.
authors.forename: L
authors.initials: L
authors.lastname: von Kobyletzki
authors.affiliation: Centre for Evidence-Based Healthcare, University of Dresden, Dresden, Germany.|Department of Occupational and Social Medicine, Technical University Dresden, Dresden, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Schmitt
authors.affiliation: Medicine Service, Birmingham VA Medical Center, Birmingham, AL, U.S.A.|Department of Medicine, University of Alabama, Birmingham, AL, U.S.A.
authors.forename: J A
authors.initials: JA
authors.lastname: Singh
authors.affiliation: Department of Dermatology and Venereology, Malmö University Hospital, Malmö, Sweden.
authors.forename: Å
authors.initials: Å
authors.lastname: Svensson
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.
authors.forename: H C
authors.initials: HC
authors.lastname: Williams
authors.affiliation: Department of Dermatology, University of California San Francisco, San Francisco, California, CA, U.S.A.
authors.forename: K
authors.initials: K
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authors.affiliation: Department of Dermatology, University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: V
authors.initials: V
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authors.affiliation: Immunology and Inflammation, Regeneron Pharmaceuticals, Inc., New York, NY, U.S.A.
authors.forename: M
authors.initials: M
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authors.affiliation: Psoriasis and Eczema Association of Norway, Oslo, Norway.
authors.forename: M
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authors.lastname: Awici-Rasmussen
authors.affiliation: Department of Dermatology, CHU de Nantes, Nantes, France.
authors.forename: S
authors.initials: S
authors.lastname: Barbarot
authors.affiliation: Institute of Clinical Medicine, University of Oslo, Oslo, Norway.|Department of Dermatology, Oslo University Hospital, Oslo, Norway.
authors.forename: T L
authors.initials: TL
authors.lastname: Berents
authors.affiliation: National Eczema Organisation, National Eczema Association, San Rafael, CA, U.S.A.
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authors.affiliation: Chugai Pharma Europe Ltd., London, U.K.
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authors.affiliation: No affiliation (patient representative U.K.).
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authors.lastname: Burton
authors.affiliation: Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: K K
authors.initials: KK
authors.lastname: Bjerring Clemmensen
authors.affiliation: Société Canadienne de l'Eczéma, Keswick, ON, Canada.
authors.forename: A
authors.initials: A
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authors.affiliation: LEO Pharma A/S, Industriparken 55, Ballerup, Denmark.
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authors.affiliation: Division of Dermatology, University Health Network, Toronto, ON, Canada.
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authors.affiliation: St John's Institute of Dermatology, Guy's and St Thomas' Hospitals NHS Foundation Trust and King's College London, London, U.K.
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authors.lastname: Flohr
authors.affiliation: LEO Pharma, Copenhagen, Denmark.
authors.forename: M
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authors.lastname: Garg
authors.affiliation: Department of Dermatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: L A A
authors.initials: LA
authors.lastname: Gerbens
authors.affiliation: National Eczema Society, London, U.K.
authors.forename: A L B
authors.initials: AL
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authors.affiliation: Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A.
authors.forename: J
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authors.lastname: Hanifin
authors.affiliation: Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Heinl
authors.affiliation: National Eczema Society, London, U.K.
authors.forename: R
authors.initials: R
authors.lastname: Humphreys
authors.affiliation: Brazilian Atopic Dermatitis Association (AADA), São Paulo, Brazil.
authors.forename: H A
authors.initials: HA
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authors.affiliation: Osaka Prefectural Medical Center for Respiratory and Allergic Disease, Osaka, Japan.
authors.forename: Y
authors.initials: Y
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authors.affiliation: Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A.
authors.forename: Y A
authors.initials: YA
authors.lastname: Leshem
authors.affiliation: No affiliation (patient representative Sweden).
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authors.initials: B
authors.lastname: Marquort
authors.affiliation: Sanofi-Aventis, Paris, France.
authors.forename: M-A
authors.initials: MA
authors.lastname: Massuel
authors.affiliation: Association Française de l'Eczéma, Redon, France.
authors.forename: S
authors.initials: S
authors.lastname: Merhand
authors.affiliation: Mie University, Graduate School of Medicine and Mie University Hospital Tsu, Mie, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Mizutani
authors.affiliation: Department of Dermatology, Osaka University, Osaka, Japan.
authors.forename: H
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authors.lastname: Murota
authors.affiliation: Department of Dermatology, St George Hospital, Sydney, Australia.|University of New South Wales, Sydney, Australia.
authors.forename: D F
authors.initials: DF
authors.lastname: Murrell
authors.affiliation: Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: T
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authors.affiliation: Retired, no affiliation.
authors.forename: I
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authors.affiliation: Celgene Corporation, Greater New York City Area Pharmaceuticals, New York, NY, U.S.A.
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authors.affiliation: Division of Allergy, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
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authors.initials: Y
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authors.affiliation: Ostermed Ltd., Kent, U.K.
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authors.affiliation: Celgene BV, Utrecht, the Netherlands.
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authors.affiliation: Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands.
authors.forename: C
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authors.lastname: Prinsen
authors.affiliation: Ziarco Pharma Ltd, Kent, U.K.
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authors.affiliation: School of Social & Community Medicine, University of Bristol, Bristol, U.K.
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authors.forename: M-L A
authors.initials: ML
authors.lastname: Schuttelaar
authors.affiliation: Department of Dermatology, Osaka University, Osaka, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Shindo
authors.affiliation: Department of Public Health Sciences, Karlstad University, Karlstad, Sweden.
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authors.affiliation: Sanofi-Aventis, Montpellier, France.
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authors.affiliation: Psoriasis and Eczema Association of Norway, Oslo, Norway.
authors.forename: E
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authors.affiliation: Department of Dermatology, University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: R
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authors.affiliation: Sanofi-Aventis, Montpellier, France.
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authors.affiliation: Mie University, Graduate School of Medicine and Mie University Hospital Tsu, Mie, Japan.
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authors.affiliation: Department of Dermatology, University of Tartu, Tartu, Estonia.
authors.forename: A
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authors.lastname: Volke
authors.affiliation: Dermatology Unit, Department of Medicine, Karolinska Institutet, Solna, Sweden.|Karolinska University Hospital, Stockholm, Sweden.
authors.forename: C-F
authors.initials: CF
authors.lastname: Wahlgren
authors.affiliation: Department of Dermatology, Venereology and Allergy University Hospital Schleswig-Holstein, Kiel, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Weidinger
authors.affiliation: Occupational and Environmental Dermatology, Department of Social Medicine, University of Heidelberg, Heidelberg, Germany.
authors.forename: E
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authors.affiliation: Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.
authors.forename: A
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authors.affiliation: Department of Dermatology, Osaka University, Osaka, Japan.
authors.forename: K
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authors.lastname: Yamaga
authors.affiliation: Department of Dermatology, St George Hospital, Sydney, Australia.|University of New South Wales, Sydney, Australia.
authors.forename: C Y
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mesh_terms: D057189:Checklist; D002986:Clinical Trials as Topic; D003876:Dermatitis, Atopic / Q000628:therapy*; D003879:Dermatologic Agents / Q000627:therapeutic use; D014943:Global Health; D006801:Humans; D008134:Long-Term Care; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D012196:Review Literature as Topic; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents