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Br J Dermatol. 2018 May;178(5):e332-e341. doi: 10.1111/bjd.16543. Epub 2018 Apr 19.

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

Author information

1
Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.
2
Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
3
Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands.
4
Department of Dermatology, Academic Medical Center, Amsterdam, the Netherlands.
5
Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A.
6
VU University Medical Center, Amsterdam, the Netherlands.
7
Department of Dermatology, Nantes University Hospital (CHU de Nantes), France.
8
Department of Dermatology, University of California San Francisco, San Francisco, CA, U.S.A.
9
University of São Paulo Medical School, São Paulo, Brazil.
10
Regeneron Pharmaceuticals, Tarrytown, NY, U.S.A.
11
Galderma, Paris, France.
12
LEO Pharma, Ballerup, Denmark.
13
Oslo University Hospital, Oslo, Norway.
14
Patient, Nottingham, U.K.
15
National Eczema Association, San Rafael, CA, U.S.A.
16
GlaxoSmithKline, Research Triangle Park, NC, U.S.A.
17
Eczema Society of Canada, Keswick, ON, Canada.
18
Eli Lilly and Company, Indianapolis, IN, U.S.A.
19
Sanofi, Chilly-Mazarin, France.
20
Rady Children's Hospital, University of California San Francisco, San Diego, CA, U.S.A.
21
St John's Institute of Dermatology, St Thomas' Hospital, London, U.K.
22
Nagoya Medical Center, Nagoya, Japan.
23
The Psoriasis and Eczema Association of Norway, Oslo, Norway.
24
Erasmus MC, University Medical Centre, Rotterdam, the Netherlands.
25
GlaxoSmithKline, Uxbridge, U.K.
26
Global Parents for Eczema Research, Brisbane, Australia.
27
National Eczema Society, London, U.K.
28
Brazilian Atopic Dermatitis Association (AADA), São Paulo, Brazil.
29
Osaka Prefectural Medical Center for Respiratory and Allergic Disease, Osaka, Japan.
30
Osaka University, Osaka, Japan.
31
Dutch Association for People with Atopic Dermatitis, Nijkerk, the Netherlands.
32
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, U.K.
33
Beilinson Hospital and Tel Aviv University, Petah Tikva and Tel Aviv, Israel.
34
Association Française de l'Eczéma, Redon, France.
35
Department of Dermatology, Osaka University, Suita, Japan.
36
Department of Dermatology, Kyushu University, Fukuoka, Japan.
37
Sanofi Genzyme, Stockholm, Sweden.
38
National Centre for Child Health and Development, Tokyo, Japan.
39
Department of Dermatology, Oslo University Hospital, Oslo, Norway.
40
Department of Dermatology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
41
Dermavant Sciences, Inc., Durham, NC, U.S.A.
42
Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center, Birmingham, AL, U.S.A.
43
Klinik und Poliklinik für Dermatologie und Allergologie der LMU - München, Munich, Germany.
44
Primary Care and Population Sciences Division, University of Southampton, Southampton, U.K.
45
Department of Dermatology and Venereology, Lund University, Malmö, Sweden.
46
The Psoriasis and Eczema Association of Norway, Haugesund, Norway.
47
AbbVie Inc., North Chicago, IL, U.S.A.
48
Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Hellerup, Denmark.
49
University of Cape Town, Cape Town, South Africa.
50
Department of Dermatology, University of Tartu, Tartu, Estonia.
51
Department of Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.
52
Department of Public Health Sciences, Karlstad University, Karlstad, Sweden.
53
CF Wahlgren, Dermatology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
54
Karolinska University Hospital, Stockholm, Sweden.
55
Department of Dermatology, Venereology and Allergy University Hospital Schleswig-Holstein, Kiel, Germany.
56
Department of Social Medicine, Occupational and Environmental Dermatology, Ruprecht Karls University, Heidelberg, Germany.
57
Ludwig-Maximilian University, Munich, Germany.
58
University of São Paulo, Campinas, Brazil.

Abstract

This is the report from the fifth meeting of the Harmonising Outcome Measures for Eczema initiative (HOME V). The meeting was held on 12-14 June 2017 in Nantes, France, with 81 participants. The main aims of the meeting were (i) to achieve consensus over the definition of the core domain of long-term control and how to measure it and (ii) to prioritize future areas of research for the measurement of the core domain of quality of life (QoL) in children. Moderated whole-group and small-group consensus discussions were informed by presentations of qualitative studies, systematic reviews and validation studies. Small-group allocations were performed a priori to ensure that each group included different stakeholders from a variety of geographical regions. Anonymous whole-group voting was carried out using handheld electronic voting pads according to predefined consensus rules. It was agreed by consensus that the long-term control domain should include signs, symptoms, quality of life and a patient global instrument. The group agreed that itch intensity should be measured when assessing long-term control of eczema in addition to the frequency of itch captured by the symptoms domain. There was no recommendation of an instrument for the core outcome domain of quality of life in children, but existing instruments were assessed for face validity and feasibility, and future work that will facilitate the recommendation of an instrument was agreed upon.

PMID:
29672835
DOI:
10.1111/bjd.16543

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