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

被引：105

作者：

Chalmers, J. R. ^{[1
]}

Simpson, E. ^{[2
]}

Apfelbacher, C. J. ^{[3
]}

Thomas, K. S. ^{[1
]}

von Kobyletzki, L. ^{[4
,5
]}

Schmitt, J. ^{[6
,7
]}

Singh, J. A. ^{[8
,9
]}

Svensson, A. ^{[10
]}

Williams, H. C. ^{[1
]}

Abuabara, K. ^{[11
]}

Aoki, V. ^{[12
]}

Ardeleanu, M. ^{[13
]}

Awici-Rasmussen, M. ^{[14
]}

Barbarot, S. ^{[15
]}

Berents, T. L. ^{[16
,17
]}

Block, J. ^{[18
]}

Bragg, A. ^{[19
]}

Burton, T.

Clemmensen, K. K. Bjerring ^{[20
]}

Creswell-Melville, A. ^{[21
]}

Dinesen, M. ^{[22
]}

Drucker, A. ^{[23
]}

Eckert, L. ^{[24
]}

Flohr, C. ^{[25
,26
]}

Garg, M. ^{[27
]}

Gerbens, L. A. A. ^{[28
]}

Graff, A. L. B. ^{[29
]}

Hanifin, J. ^{[2
]}

Heinl, D. ^{[3
]}

Humphreys, R. ^{[29
]}

Ishii, H. A. ^{[30
]}

Kataoka, Y. ^{[31
]}

Leshem, Y. A. ^{[2
]}

Marquort, B.

Massuel, M. -A. ^{[32
]}

Merhand, S. ^{[33
]}

Mizutani, H. ^{[34
,35
]}

Murota, H. ^{[36
]}

Murrell, D. F. ^{[37
,38
]}

Nakahara, T. ^{[39
]}

Nasr, I.

Nograles, K. ^{[40
]}

Ohya, Y. ^{[41
]}

Osterloh, I. ^{[42
]}

Pander, J. ^{[43
]}

Prinsen, C. ^{[44
]}

Purkins, L. ^{[45
]}

Ridd, M. ^{[46
]}

Sach, T. ^{[47
]}

Schuttelaar, M. -L. A. ^{[48
]}

机构：

[1] Univ Nottingham, Ctr Evidence Based Dermatol, Nottingham, England

[2] Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA

[3] Univ Regensburg, Inst Epidemiol & Prevent Med, Med Sociol, D-93053 Regensburg, Germany

[4] Lund Univ, Skane Univ Hospital, Dept Dermatol, Malmo, Sweden

[5] Karlstad Univ, Dept Publ Hlth Sci, Karlstad, Sweden

[6] Univ Dresden, Ctr Lvidence Based Hlthcare, Dresden, Germany

[7] Tech Univ Dresden, Dept Occupat & Social Med, D-01062 Dresden, Germany

[8] Birmingham VA Med Ctr, Med Serv, Birmingham, AL USA

[9] Univ Alabama Birmingham, Dept Med, Birmingham, AL 35294 USA

[10] Malmo Univ Hosp, Dept Dermatol & Venerol, Malmo, Sweden

[11] Univ Calif San Francisco, Dept Dermatol, San Francisco, CA 94143 USA

[12] Univ Sao Paulo, Sch Med, Dept Dermatol, Sao Paulo, Brazil

[13] Regeneron Pharmaceut Inc, Immunol & Inflammat, New York, NY USA

[14] Psoriasis & Eczema Assoc Norway, Oslo, Norway

[15] CHU Nantes, Dept Dermatol, F-44035 Nantes 01, France

[16] Univ Oslo, Inst Clin Med, Oslo 3, Norway

[17] Oslo Univ Hosp, Dept Dermatol, Oslo, Norway

[18] Natl Eczema Assoc, Natl Eczema Org, San Rafael, CA USA

[19] Chugai Pharma Europe Ltd, London, England

[20] Univ Copenhagen, Bispebjerg Hosp, Dept Dermatol, Copenhagen, Denmark

[21] Soc Canadienne IEczema, Keswick, ON, Canada

[22] LEO Pharma AS, Industriparken 55, Ballerup, Denmark

[23] Univ Hlth Nem ork, Div Dermatol, Toronto, ON, Canada

[24] Hlth Econ & Outcomes Res, Sanofi, France

[25] Guys & St Thomas Hosp NHS Fdn Trust, St Johns Inst Dermatol, London, England

[26] Kings Coll London, London, England

[27] LEO Pharma, Copenhagen, Denmark

[28] Univ Amsterdam, Acad Med Ctr, Dept Dermatol, Amsterdam, Netherlands

[29] Natl Eczema Soc, London, England

[30] Brazilian Atop Dermatitis Assoc AADA, Sao Paulo, Brazil

[31] Osaka Prefectural Med Ctr Resp & Allerg Dis, Osaka, Japan

[32] Sanofi Aventis, Paris, France

[33] Assoc Francaise Eczema, Redon, France

[34] Mie Univ, Grad Sch Med, Tsu, Mie, Japan

[35] Mie Univ, Hosp Tsu, Tsu, Mie, Japan

[36] Osaka Univ, Dept Dermatol, Osaka, Japan

[37] St George Hosp, Dept Dermatol, Sydney, NSW, Australia

[38] Univ New S Wales, Sydney, NSW, Australia

[39] Kyushu Univ, Grad Sch Med Sci, Dept Dermatol, Fukuoka, Japan

[40] Greater New York City Area Pharmaceut, Celgene Corp, New York, NY USA

[41] Natl Ctr Child Hlth & Dev, Dept Med Subspecialties, Div Allergy, Tokyo, Japan

[42] Ostermed Ltd, Kent, OH USA

[43] Celgene BV, Utrecht, Netherlands

[44] Vrije Univ Amsterdam Med Ctr, EMGO Inst Hlth & Care Res, Dept Epidemiol & Biostat, Amsterdam, Netherlands

[45] Ziarco Pharma Ltd, Canterbury, Kent, England

[46] Univ Bristol, Sch Social & Community Med, Bristol, Avon, England

[47] Univ E Anglia, Hlth Econ Grp, Norwich, Norfolk, England

[48] Univ Groningen, Univ Med Ctr Groningen, Dept Dermatol, Groningen, Netherlands

[49] Sanofi Aventis, Montpellier, France

[50] Toulouse Univ, Toulouse, France

来源：

BRITISH JOURNAL OF DERMATOLOGY | 2016年 / 175卷 / 01期

基金：

美国国家卫生研究院;

关键词：

MEASUREMENT INSTRUMENTS; ECZEMA; QUALITY; COSMIN; SIGNS;

D O I：

10.1111/bjd.14773

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmo, 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.

引用

页码：69 / 79

页数：11

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