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

J. R. Chalmers; E. Simpson; C. J. Apfelbacher; K. S. Thomas; L. von Kobyletzki; J. Schmitt; J. A. Singh; 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; C. Flohr; M. Garg; L. A.A. Gerbens; A. L.B. Graff; J. Hanifin; D. Heinl; R. 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; M. L.A. Schuttelaar

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
, E. Simpson
, C. J. Apfelbacher
, K. S. Thomas
, L. von Kobyletzki
, J. Schmitt
, J. A. Singh
, 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, C. Flohr, M. Garg, L. A.A. Gerbens, A. L.B. Graff, J. Hanifin, D. Heinl, R. 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, M. L.A. Schuttelaar

Dermatology

University of Nottingham
Oregon Health & Science University
University Regensburg
Department of Clinical Sciences
Karlstad University
TU Dresden
Birmingham VA Medical Center
University of Alabama
Skånes universitetssjukhus
University of California, San Francisco
Universidade de Sao Paulo - USP
Regeneron Pharmaceuticals, Inc.
The Psoriasis and Eczema Association of Norway
Institut National de la Santé et de la Recherche Médicale, U1064, Institut de Transplantation Urologie Néphrologie , Nantes , France ; Faculté de Médecine, Université de Nantes , Nantes , France ; Centre Hospitalier Universitaire, Hôtel Dieu , Nantes , France.
University of Oslo
National Eczema Association
Chugai Pharma Europe Ltd
University of Copenhagen
Société Canadienne de l'Eczéma
LEO Pharma AS
University of Toronto
Sanofi S.A.
GSTT Guy's and St Thomas' NHS Foundation Trust
LEO Pharma
University of Amsterdam
National Eczema Society
Brazilian Atopic Dermatitis Association (AADA)
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Association Française de l'Eczéma
Mie University
Osaka University
St George Hospital
Kensington
Graduate School of Medical Sciences
Celgene Corporation
National Center for Child Health and Development
OsterMed Ltd.
Celgene BV
VU University Hospital
Ziarco Pharma Ltd
University of Bristol
University of East Anglia
University Medical Center Groningen

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

120 Citations (Scopus)

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

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Chalmers, J. R., Simpson, E., Apfelbacher, C. J., Thomas, K. S., von Kobyletzki, L., Schmitt, J., Singh, J. A., Svensson, Williams, H. C., Abuabara, K., Aoki, V., Ardeleanu, M., Awici-Rasmussen, M., Barbarot, S., Berents, T. L., Block, J., Bragg, A., Burton, T., Bjerring Clemmensen, K. K., ... Schuttelaar, M. L. A. (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

@article{0dfa5735310e4d71bfcace80fc2ea1d4,

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 E. Simpson and Apfelbacher, \{C. J.\} and Thomas, \{K. S.\} and \{von Kobyletzki\}, L. and J. Schmitt and Singh, \{J. A.\} and 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 \{Bjerring Clemmensen\}, \{K. K.\} and A. Creswell-Melville and M. Dinesen and A. Drucker and L. Eckert and C. Flohr and M. Garg and Gerbens, \{L. A.A.\} and Graff, \{A. L.B.\} and J. Hanifin and D. Heinl and R. Humphreys 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, \{M. L.A.\}",

note = "Publisher Copyright: {\textcopyright} 2016 The Authors. British Journal of Dermatology published by John Wiley \& Sons Ltd on behalf of British Association of Dermatologists.",

year = "2016",

month = jul,

day = "1",

doi = "10.1111/bjd.14773",

language = "English",

volume = "175",

pages = "69--79",

journal = "British Journal of Dermatology",

issn = "0007-0963",

publisher = "Oxford University Press",

number = "1",

}

Chalmers, JR, Simpson, E, Apfelbacher, CJ, Thomas, KS, von Kobyletzki, L, Schmitt, J, Singh, JA, Svensson, Williams, HC, Abuabara, K, Aoki, V, Ardeleanu, M, Awici-Rasmussen, M, Barbarot, S, Berents, TL, Block, J, Bragg, A, Burton, T, Bjerring Clemmensen, KK, Creswell-Melville, A, Dinesen, M, Drucker, A, Eckert, L, Flohr, C, Garg, M, Gerbens, LAA, Graff, ALB, Hanifin, J, Heinl, D, Humphreys, R, 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, MLA 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

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, E.

AU - Apfelbacher, C. J.

AU - Thomas, K. S.

AU - von Kobyletzki, L.

AU - Schmitt, J.

AU - Singh, J. A.

AU - Svensson,

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 - Bjerring Clemmensen, K. K.

AU - Creswell-Melville, A.

AU - Dinesen, M.

AU - Drucker, A.

AU - Eckert, L.

AU - Flohr, C.

AU - Garg, M.

AU - Gerbens, L. A.A.

AU - Graff, A. L.B.

AU - Hanifin, J.

AU - Heinl, D.

AU - Humphreys, R.

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, M. L.A.

PY - 2016/7/1

Y1 - 2016/7/1

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.

UR - https://www.scopus.com/pages/publications/84982965481

U2 - 10.1111/bjd.14773

DO - 10.1111/bjd.14773

M3 - Article

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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