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

J. R. Chalmers; Elizabeth M Simpson; C. J. Apfelbacher; K. S. Thomas; L. von Kobyletzki; J. Schmitt; Jasvinder A Singh; Staffan Svensson; H. C. Williams; K. Abuabara; V. Aoki; M. Ardeleanu; M. Awici-Rasmussen; S. Barbarot; T. L. Berents; J Block; A. Bragg; T. Burton; K. K. Bjerring Clemmensen; A. Creswell-Melville; M. Dinesen; A. Drucker; L. Eckert; Carsten Flohr; M. Garg; L. A A Gerbens; A. L B Graff; Jon M Hanifin; D. Heinl; R. D. Humphreys; H. A. Ishii; Y. Kataoka; Y. A. Leshem; B. Marquort; M. A. Massuel; S. Merhand; H. Mizutani; H. Murota; D. F. Murrell; T. Nakahara; I. Nasr; K. Nograles; Y. Ohya; I. Osterloh; J. Pander; C. Prinsen; L. Purkins; M. Ridd; T. Sach; Marie-Louise A Schuttelaar; S. Shindo; J. Smirnova; A. Sulzer; E. Synnøve Gjerde; R. Takaoka; H. Vestby Talmo; M Tauber; F. Torchet; A. Volke; C. F. Wahlgren; S Weidinger; Elke Weisshaar; A. Wollenberg; K. Yamaga; Z. Y. Zhao; P. I. Spuls

doi:10.1111/bjd.14773

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

J. R. Chalmers, Elizabeth M Simpson, C. J. Apfelbacher, K. S. Thomas, L. von Kobyletzki, J. Schmitt, Jasvinder A Singh, Staffan Svensson, H. C. Williams, K. Abuabara, V. Aoki, M. Ardeleanu, M. Awici-Rasmussen, S. Barbarot, T. L. Berents, J Block, A. Bragg, T. Burton, K. K. Bjerring Clemmensen, A. Creswell-MelvilleM. Dinesen, A. Drucker, L. Eckert, Carsten Flohr, M. Garg, L. A A Gerbens, A. L B Graff, Jon M Hanifin, D. Heinl, R. D. Humphreys, H. A. Ishii, Y. Kataoka, Y. A. Leshem, B. Marquort, M. A. Massuel, S. Merhand, H. Mizutani, H. Murota, D. F. Murrell, T. Nakahara, I. Nasr, K. Nograles, Y. Ohya, I. Osterloh, J. Pander, C. Prinsen, L. Purkins, M. Ridd, T. Sach, Marie-Louise A Schuttelaar, S. Shindo, J. Smirnova, A. Sulzer, E. Synnøve Gjerde, R. Takaoka, H. Vestby Talmo, M Tauber, F. Torchet, A. Volke, C. F. Wahlgren, S Weidinger, Elke Weisshaar, A. Wollenberg, K. Yamaga, Z. Y. Zhao, P. I. Spuls^*

^*Corresponding author for this work

Morphogenesis and Differentiation Program

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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.

Original language	English
Journal	British Journal of Dermatology
Volume	175
Issue number	1
Pages (from-to)	69-79
Number of pages	11
ISSN	0007-0963
DOIs	https://doi.org/10.1111/bjd.14773
Publication status	Published - Jul 2016

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Chalmers, J. R., Simpson, E. M., Apfelbacher, C. J., Thomas, K. S., von Kobyletzki, L., Schmitt, J., Singh, J. A., Svensson, S., Williams, H. C., Abuabara, K., Aoki, V., Ardeleanu, M., Awici-Rasmussen, M., Barbarot, S., Berents, T. L., Block, J., Bragg, A., Burton, T., Clemmensen, K. K. B., ... Spuls, P. I. (2016). Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative). British Journal of Dermatology, 175(1), 69-79. https://doi.org/10.1111/bjd.14773

Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative). / Chalmers, J. R.; Simpson, Elizabeth M; Apfelbacher, C. J. et al.

In: British Journal of Dermatology, Vol. 175, No. 1, 07.2016, p. 69-79.

Research output: Contribution to journal › Comment/debate › Research › peer-review

Chalmers, JR, Simpson, EM, Apfelbacher, CJ, Thomas, KS, von Kobyletzki, L, Schmitt, J, Singh, JA, Svensson, S, Williams, HC, Abuabara, K, Aoki, V, Ardeleanu, M, Awici-Rasmussen, M, Barbarot, S, Berents, TL, Block, J, Bragg, A, Burton, T, Clemmensen, KKB, Creswell-Melville, A, Dinesen, M, Drucker, A, Eckert, L, Flohr, C, Garg, M, Gerbens, LAA, Graff, ALB, Hanifin, JM, Heinl, D, Humphreys, RD, Ishii, HA, Kataoka, Y, Leshem, YA, Marquort, B, Massuel, MA, Merhand, S, Mizutani, H, Murota, H, Murrell, DF, Nakahara, T, Nasr, I, Nograles, K, Ohya, Y, Osterloh, I, Pander, J, Prinsen, C, Purkins, L, Ridd, M, Sach, T, Schuttelaar, M-LA, Shindo, S, Smirnova, J, Sulzer, A, Synnøve Gjerde, E, Takaoka, R, Vestby Talmo, H, Tauber, M, Torchet, F, Volke, A, Wahlgren, CF, Weidinger, S, Weisshaar, E, Wollenberg, A, Yamaga, K, Zhao, ZY & Spuls, PI 2016, 'Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)', British Journal of Dermatology, vol. 175, no. 1, pp. 69-79. https://doi.org/10.1111/bjd.14773

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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 Malm{\"o}, 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.",

author = "Chalmers, {J. R.} and Simpson, {Elizabeth M} and Apfelbacher, {C. J.} and Thomas, {K. S.} and {von Kobyletzki}, L. and J. Schmitt and Singh, {Jasvinder A} and Staffan Svensson and Williams, {H. C.} and K. Abuabara and V. Aoki and M. Ardeleanu and M. Awici-Rasmussen and S. Barbarot and Berents, {T. L.} and J Block and A. Bragg and T. Burton and Clemmensen, {K. K. Bjerring} and A. Creswell-Melville and M. Dinesen and A. Drucker and L. Eckert and Carsten Flohr and M. Garg and Gerbens, {L. A A} and Graff, {A. L B} and Hanifin, {Jon M} and D. Heinl and Humphreys, {R. D.} and Ishii, {H. A.} and Y. Kataoka and Leshem, {Y. A.} and B. Marquort and Massuel, {M. A.} and S. Merhand and H. Mizutani and H. Murota and Murrell, {D. F.} and T. Nakahara and I. Nasr and K. Nograles and Y. Ohya and I. Osterloh and J. Pander and C. Prinsen and L. Purkins and M. Ridd and T. Sach and Schuttelaar, {Marie-Louise A} and S. Shindo and J. Smirnova and A. Sulzer and {Synn{\o}ve Gjerde}, E. and R. Takaoka and {Vestby Talmo}, H. and M Tauber and F. Torchet and A. Volke and Wahlgren, {C. F.} and S Weidinger and Elke Weisshaar and A. Wollenberg and K. Yamaga and Zhao, {Z. Y.} and Spuls, {P. I.}",

year = "2016",

month = jul,

doi = "10.1111/bjd.14773",

language = "English",

volume = "175",

pages = "69--79",

journal = "British Journal of Dermatology",

issn = "0007-0963",

publisher = "Wiley-Blackwell",

number = "1",

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TY - JOUR

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

AU - Chalmers, J. R.

AU - Simpson, Elizabeth M

AU - Apfelbacher, C. J.

AU - Thomas, K. S.

AU - von Kobyletzki, L.

AU - Schmitt, J.

AU - Singh, Jasvinder A

AU - Svensson, Staffan

AU - Williams, H. C.

AU - Abuabara, K.

AU - Aoki, V.

AU - Ardeleanu, M.

AU - Awici-Rasmussen, M.

AU - Barbarot, S.

AU - Berents, T. L.

AU - Block, J

AU - Bragg, A.

AU - Burton, T.

AU - Clemmensen, K. K. Bjerring

AU - Creswell-Melville, A.

AU - Dinesen, M.

AU - Drucker, A.

AU - Eckert, L.

AU - Flohr, Carsten

AU - Garg, M.

AU - Gerbens, L. A A

AU - Graff, A. L B

AU - Hanifin, Jon M

AU - Heinl, D.

AU - Humphreys, R. D.

AU - Ishii, H. A.

AU - Kataoka, Y.

AU - Leshem, Y. A.

AU - Marquort, B.

AU - Massuel, M. A.

AU - Merhand, S.

AU - Mizutani, H.

AU - Murota, H.

AU - Murrell, D. F.

AU - Nakahara, T.

AU - Nasr, I.

AU - Nograles, K.

AU - Ohya, Y.

AU - Osterloh, I.

AU - Pander, J.

AU - Prinsen, C.

AU - Purkins, L.

AU - Ridd, M.

AU - Sach, T.

AU - Schuttelaar, Marie-Louise A

AU - Shindo, S.

AU - Smirnova, J.

AU - Sulzer, A.

AU - Synnøve Gjerde, E.

AU - Takaoka, R.

AU - Vestby Talmo, H.

AU - Tauber, M

AU - Torchet, F.

AU - Volke, A.

AU - Wahlgren, C. F.

AU - Weidinger, S

AU - Weisshaar, Elke

AU - Wollenberg, A.

AU - Yamaga, K.

AU - Zhao, Z. Y.

AU - Spuls, P. I.

PY - 2016/7

Y1 - 2016/7

N2 - 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.

AB - 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.

U2 - 10.1111/bjd.14773

DO - 10.1111/bjd.14773

M3 - Comment/debate

C2 - 27436240

AN - SCOPUS:84982965481

SN - 0007-0963

VL - 175

SP - 69

EP - 79

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 1

ER -

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

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