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

J. R. Chalmers; K. S. Thomas; C. Apfelbacher; H. C. Williams; C. A. Prinsen; P. I. Spuls; E. Simpson; L. A.A. Gerbens; M. Boers; S. Barbarot; J. F. Stalder; K. Abuabara; V. Aoki; M. Ardeleanu; J. Armstrong; B. Bang; T. L. Berents; T. Burton; L. Butler; T. Chubachi; A. Cresswell-Melville; A. DeLozier; L. Eckert; L. Eichenfield; C. Flohr; M. Futamura; A. Gadkari; E. S. Gjerde; K. F. van Halewijn; C. Hawkes; L. Howells; L. Howie; R. Humphreys; H. A. Ishii; Y. Kataoka; I. Katayama; W. Kouwenhoven; S. M. Langan; Y. A. Leshem; S. Merhand; P. Mina-Osorio; H. Murota; T. Nakahara; F. P. Nunes; U. Nygaard; M. Nygårdas; Y. Ohya; E. Ono; E. Rehbinder; N. K. Rogers; G. L.E. Romeijn; M. L.A. Schuttelaar; A. V. Sears; M. A. Simpson; J. A. Singh; J. Srour; B. Stuart; Svensson; G. Talmo; H. Talmo; H. D. Teixeira; J. P. Thyssen; G. Todd; F. Torchet; A. Volke; L. von Kobyletzki; E. Weisshaar; A. Wollenberg; M. Zaniboni

doi:10.1111/bjd.16543

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

J. R. Chalmers^*
, K. S. Thomas
, C. Apfelbacher
, H. C. Williams
, C. A. Prinsen
, P. I. Spuls
, E. Simpson
, L. A.A. Gerbens
, M. Boers
, S. Barbarot
, J. F. Stalder
, K. Abuabara
, V. Aoki
, M. Ardeleanu
, J. Armstrong
, B. Bang
, T. L. Berents
, T. Burton
, L. Butler
, T. Chubachi

A. Cresswell-Melville, A. DeLozier, L. Eckert, L. Eichenfield, C. Flohr, M. Futamura, A. Gadkari, E. S. Gjerde, K. F. van Halewijn, C. Hawkes, L. Howells, L. Howie, R. Humphreys, H. A. Ishii, Y. Kataoka, I. Katayama, W. Kouwenhoven, S. M. Langan, Y. A. Leshem, S. Merhand, P. Mina-Osorio, H. Murota, T. Nakahara, F. P. Nunes, U. Nygaard, M. Nygårdas, Y. Ohya, E. Ono, E. Rehbinder, N. K. Rogers, G. L.E. Romeijn, M. L.A. Schuttelaar, A. V. Sears, M. A. Simpson, J. A. Singh, J. Srour, B. Stuart, Svensson, G. Talmo, H. Talmo, H. D. Teixeira, J. P. Thyssen, G. Todd, F. Torchet, A. Volke, L. von Kobyletzki, E. Weisshaar, A. Wollenberg, M. Zaniboni

^*Corresponding author for this work

Dermatology

Center of Evidence-based Dermatology
University of Nottingham
Medical Sociology
University of Regensburg
Department of Epidemiology and Biostatistics
Vrije Universiteit (VU) and VU Medical Centre
Department of Dermatology
Academic Medical Centre
Oregon Health and Science University
Department of Dermatology
Service de Cardiologie
Department of Dermatology
University of California at San Francisco
Universidade de São Paulo
Regeneron Pharmaceuticals, Inc.
Galderma International
LEO Pharma AS
University of Oslo
Patient
National Eczema Association
GlaxoSmithKline
Eczema Society of Canada
Eli Lilly
Sanofi-Aventis
King's College London
National Hospital Organization Nagoya Medical Center
The Psoriasis and Eczema Association of Norway
Erasmus University Rotterdam
Global Parents for Eczema Research
National Eczema Society
Brazilian Atopic Dermatitis Association (AADA)
Osaka Habikino Medical Center
The University of Osaka
Dutch Association for People with Atopic Dermatitis
Faculty of Epidemiology and Population Health
London School of Hygiene and Tropical Medicine
Association Française de l'Eczéma
Department of Dermatology
Department of Dermatology
Kyushu University
Sanofi Genzyme
National Center for Child Health and Development
Department of Dermatology
Department of Dermatology
University of Groningen
Dermavant Sciences
University of Alabama at Birmingham
Ludwig Maximilian University of Munich
Primary Care and Population Sciences Division
University of Southampton
Department of Dermatology and Venereology
Lund University
The Psoriasis and Eczema Association of Norway
AbbVie
Department of Dermatology and Allergy
University of Copenhagen
University of Cape Town
Department of Dermatology
University of Tartu
Skåne University Hospital
Department of Public Health Sciences
Karlstad University
CF Wahlgren
Karolinska Institutet
Department of Dermatology
University Medical Center Schleswig- Holstein
Department of Social Medicine
Heidelberg University

Research output: Contribution to journal › Article › peer-review

80 Scopus citations

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.

Original language	English
Pages (from-to)	e332-e341
Journal	British Journal of Dermatology
Volume	178
Issue number	5
DOIs	https://doi.org/10.1111/bjd.16543
State	Published - May 2018

Funding

Funders
DHU 2020
Department of Dermatology CHU Nantes
School of Medicine, University of Nottingham
University of Nottingham
Chung Hua University
Université de Nantes

Access to Document

10.1111/bjd.16543

Cite this

Chalmers, J. R., Thomas, K. S., Apfelbacher, C., Williams, H. C., Prinsen, C. A., Spuls, P. I., Simpson, E., Gerbens, L. A. A., Boers, M., Barbarot, S., Stalder, J. F., Abuabara, K., Aoki, V., Ardeleanu, M., Armstrong, J., Bang, B., Berents, T. L., Burton, T., Butler, L., ... Zaniboni, M. (2018). Report from the fifth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative). British Journal of Dermatology, 178(5), e332-e341. https://doi.org/10.1111/bjd.16543

@article{35f349e4a97b4d8b8661a2402a2391d3,

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

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{\textendash}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.",

author = "Chalmers, \{J. R.\} and Thomas, \{K. S.\} and C. Apfelbacher and Williams, \{H. C.\} and Prinsen, \{C. A.\} and Spuls, \{P. I.\} and E. Simpson and Gerbens, \{L. A.A.\} and M. Boers and S. Barbarot and Stalder, \{J. F.\} and K. Abuabara and V. Aoki and M. Ardeleanu and J. Armstrong and B. Bang and Berents, \{T. L.\} and T. Burton and L. Butler and T. Chubachi and A. Cresswell-Melville and A. DeLozier and L. Eckert and L. Eichenfield and C. Flohr and M. Futamura and A. Gadkari and Gjerde, \{E. S.\} and \{van Halewijn\}, \{K. F.\} and C. Hawkes and L. Howells and L. Howie and R. Humphreys and Ishii, \{H. A.\} and Y. Kataoka and I. Katayama and W. Kouwenhoven and Langan, \{S. M.\} and Leshem, \{Y. A.\} and S. Merhand and P. Mina-Osorio and H. Murota and T. Nakahara and Nunes, \{F. P.\} and U. Nygaard and M. Nyg{\aa}rdas and Y. Ohya and E. Ono and E. Rehbinder and Rogers, \{N. K.\} and Romeijn, \{G. L.E.\} and Schuttelaar, \{M. L.A.\} and Sears, \{A. V.\} and Simpson, \{M. A.\} and Singh, \{J. A.\} and J. Srour and B. Stuart and Svensson and G. Talmo and H. Talmo and Teixeira, \{H. D.\} and Thyssen, \{J. P.\} and G. Todd and F. Torchet and A. Volke and \{von Kobyletzki\}, L. and E. Weisshaar and A. Wollenberg and M. Zaniboni",

note = "Publisher Copyright: {\textcopyright} 2018 The Authors. British Journal of Dermatology published by John Wiley \& Sons Ltd on behalf of British Association of Dermatologists",

year = "2018",

month = may,

doi = "10.1111/bjd.16543",

language = "אנגלית",

volume = "178",

pages = "e332--e341",

journal = "British Journal of Dermatology",

issn = "0007-0963",

publisher = "Oxford University Press",

number = "5",

}

Chalmers, JR, Thomas, KS, Apfelbacher, C, Williams, HC, Prinsen, CA, Spuls, PI, Simpson, E, Gerbens, LAA, Boers, M, Barbarot, S, Stalder, JF, Abuabara, K, Aoki, V, Ardeleanu, M, Armstrong, J, Bang, B, Berents, TL, Burton, T, Butler, L, Chubachi, T, Cresswell-Melville, A, DeLozier, A, Eckert, L, Eichenfield, L, Flohr, C, Futamura, M, Gadkari, A, Gjerde, ES, van Halewijn, KF, Hawkes, C, Howells, L, Howie, L, Humphreys, R, Ishii, HA, Kataoka, Y, Katayama, I, Kouwenhoven, W, Langan, SM, Leshem, YA, Merhand, S, Mina-Osorio, P, Murota, H, Nakahara, T, Nunes, FP, Nygaard, U, Nygårdas, M, Ohya, Y, Ono, E, Rehbinder, E, Rogers, NK, Romeijn, GLE, Schuttelaar, MLA, Sears, AV, Simpson, MA, Singh, JA, Srour, J, Stuart, B, Svensson, Talmo, G, Talmo, H, Teixeira, HD, Thyssen, JP, Todd, G, Torchet, F, Volke, A, von Kobyletzki, L, Weisshaar, E, Wollenberg, A & Zaniboni, M 2018, 'Report from the fifth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)', British Journal of Dermatology, vol. 178, no. 5, pp. e332-e341. https://doi.org/10.1111/bjd.16543

TY - JOUR

T1 - Report from the fifth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)

AU - Chalmers, J. R.

AU - Thomas, K. S.

AU - Apfelbacher, C.

AU - Williams, H. C.

AU - Prinsen, C. A.

AU - Spuls, P. I.

AU - Simpson, E.

AU - Gerbens, L. A.A.

AU - Boers, M.

AU - Barbarot, S.

AU - Stalder, J. F.

AU - Abuabara, K.

AU - Aoki, V.

AU - Ardeleanu, M.

AU - Armstrong, J.

AU - Bang, B.

AU - Berents, T. L.

AU - Burton, T.

AU - Butler, L.

AU - Chubachi, T.

AU - Cresswell-Melville, A.

AU - DeLozier, A.

AU - Eckert, L.

AU - Eichenfield, L.

AU - Flohr, C.

AU - Futamura, M.

AU - Gadkari, A.

AU - Gjerde, E. S.

AU - van Halewijn, K. F.

AU - Hawkes, C.

AU - Howells, L.

AU - Howie, L.

AU - Humphreys, R.

AU - Ishii, H. A.

AU - Kataoka, Y.

AU - Katayama, I.

AU - Kouwenhoven, W.

AU - Langan, S. M.

AU - Leshem, Y. A.

AU - Merhand, S.

AU - Mina-Osorio, P.

AU - Murota, H.

AU - Nakahara, T.

AU - Nunes, F. P.

AU - Nygaard, U.

AU - Nygårdas, M.

AU - Ohya, Y.

AU - Ono, E.

AU - Rehbinder, E.

AU - Rogers, N. K.

AU - Romeijn, G. L.E.

AU - Schuttelaar, M. L.A.

AU - Sears, A. V.

AU - Simpson, M. A.

AU - Singh, J. A.

AU - Srour, J.

AU - Stuart, B.

AU - Svensson,

AU - Talmo, G.

AU - Talmo, H.

AU - Teixeira, H. D.

AU - Thyssen, J. P.

AU - Todd, G.

AU - Torchet, F.

AU - Volke, A.

AU - von Kobyletzki, L.

AU - Weisshaar, E.

AU - Wollenberg, A.

AU - Zaniboni, M.

PY - 2018/5

Y1 - 2018/5

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85047548967

U2 - 10.1111/bjd.16543

DO - 10.1111/bjd.16543

M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???

C2 - 29672835

AN - SCOPUS:85047548967

SN - 0007-0963

VL - 178

SP - e332-e341

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 5

ER -

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

Abstract

Funding

Access to Document

Other files and links

Fingerprint

Cite this