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; null 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. ChubachiA. 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

Department of Clinical Medicine

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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
Journal	British Journal of Dermatology
Volume	178
Issue number	5
Pages (from-to)	e332-e341
ISSN	0007-0963
DOIs	https://doi.org/10.1111/bjd.16543
Publication status	Published - 2018

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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

Report from the fifth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative). / Chalmers, J. R.; Thomas, K. S.; Apfelbacher, C. et al.
In: British Journal of Dermatology, Vol. 178, No. 5, 2018, p. e332-e341.

Research output: Contribution to journal › Journal article › Research › peer-review

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

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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 12–14 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",

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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, null

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

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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.

U2 - 10.1111/bjd.16543

DO - 10.1111/bjd.16543

M3 - Journal 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)

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