Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting

被引：174

作者：

Schmitt, Jochen ^{[1
,2
]}

Spuls, Phyllis ^{[3
]}

Boers, Maarten ^{[4
]}

Thomas, Kim ^{[5
]}

Chalmers, Joanne ^{[5
]}

Roekevisch, Evelien ^{[3
]}

Schram, Mandy ^{[3
]}

Allsopp, Richard ^{[6
]}

Aoki, Valeria

Apfelbacher, Christian ^{[8
,9
]}

Bruijnzeel-Koomen, Carla ^{[10
]}

Bruin-Weller, Marjolein ^{[11
]}

Charman, Carolyn ^{[12
]}

Cohen, Arnon ^{[13
]}

Dohil, Magdalene ^{[14
]}

Flohr, Carsten ^{[15
,16
]}

Furue, Masutaka ^{[17
]}

Gieler, Uwe ^{[18
]}

Hooft, Lotty ^{[19
]}

Humphreys, Rosemary ^{[20
]}

Ishii, Henrique Akira ^{[21
]}

Katayama, Ichiro ^{[22
]}

Kouwenhoven, Willem

Langan, Sinead ^{[15
,23
]}

Lewis-Jones, Sue ^{[24
]}

Merhand, Stephanie ^{[25
]}

Murota, Hiroyuki ^{[22
]}

Murrell, Dedee F. ^{[26
,27
]}

Nankervis, Helen ^{[5
]}

Ohya, Yukihiro ^{[28
]}

Oranje, Arnold ^{[29
,30
]}

Otsuka, Hiromi ^{[31
]}

Paul, Carle ^{[32
]}

Rosenbluth, Yael

Saeki, Hidehisa ^{[33
]}

Schuttelaar, Marie-Louise ^{[34
]}

Stalder, Jean-Francois ^{[35
]}

Svensson, Ake ^{[36
]}

Takaoka, Roberto ^{[7
]}

Wahlgren, Carl-Fredrik ^{[37
,38
]}

Weidinger, Stephan ^{[39
]}

Wollenberg, Andreas ^{[40
]}

Williams, Hywel ^{[5
,41
]}

机构：

[1] Univ Hosp Dresden, Ctr Evidence Based Healthcare, Dresden, Germany

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

[3] Univ Amsterdam, Acad Med Ctr, Dept Dermatol, NL-1105 AZ Amsterdam, Netherlands

[4] Vrije Univ Amsterdam, Dept Epidemiol & Biostat, Med Ctr, Amsterdam, Netherlands

[5] Univ Nottingham, Ctr Evidence Based Dermatol, Nottingham NG7 2RD, England

[6] Astellas Pharma Europe Ltd, Staines, England

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

[8] Univ Regensburg, Dept Epidemiol & Prevent Med, Regensburg, Germany

[9] Univ Heidelberg Hosp, Dept Clin Social Med, Heidelberg, Germany

[10] Univ Utrecht Hosp, Dept Dermatol, Utrecht, Netherlands

[11] Univ Med Ctr Utrecht, Dept Dermatol & Allergol, Utrecht, Netherlands

[12] Royal Devon & Exeter Hosp, Dept Dermatol, Exeter EX2 5DW, Devon, England

[13] Clalit Hlth Serv, Dept Qual Measures & Res, Chief Physician Off, Tel Aviv, Israel

[14] Univ Calif San Diego, Rady Childrens Hosp, San Diego, CA 92103 USA

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

[16] Kings Coll London, London WC2R 2LS, England

[17] Kyushu Univ, Dept Dermatol, Fukuoka 812, Japan

[18] Univ Giessen, Giessen, Germany

[19] Univ Amsterdam, Acad Med Ctr, Dutch Cochrane Ctr, NL-1105 AZ Amsterdam, Netherlands

[20] Natl Eczema Soc, London, England

[21] Univ Sao Paulo, Dept Min Engn & Petr, Polytech Sch, Sao Paulo, Brazil

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

[23] London Sch Hyg & Trop Med, Dept Epidemiol & Populat Hlth, London WC1, England

[24] Univ Dundee, Ninewells Hosp & Med Sch, Dept Dermatol, Dundee DD1 9SY, Tayside, Scotland

[25] French Assoc Eczema, Nantes, France

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

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

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

[29] Erasmus MC Sophia Childrens Hosp, Div Pediat Dermatol, Dept Pediat, Rotterdam, Netherlands

[30] Maasstad Ziekenhuis, Dept Dermatol, Rotterdam, Netherlands

[31] Japan Allergy Volunteer Assoc, Tokyo, Japan

[32] Univ Toulouse 3, Dept Dermatol, F-31062 Toulouse, France

[33] Jikei Univ, Dept Dermatol, Sch Med, Tokyo, Japan

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

[35] Nantes Univ Hosp, Dept Dermatol, Nantes, France

[36] Univ Hosp, Dept Dermatol, Malmo, Sweden

[37] Karolinska Inst, Dept Med Solna, Dermatol Unit, Solna, Sweden

[38] Karolinska Univ Hosp, Solna, Sweden

[39] Univ Hosp Schleswig Holstein, Dept Dermatol Allergol & Venerol, Kiel, Germany

[40] Univ Munich, Dept Dermatol & Allergy, Munich, Germany

[41] Nottingham Univ Hosp NHS Trust, Dept Dermatol, Nottingham, England

来源：

ALLERGY | 2012年 / 67卷 / 09期

关键词：

atopic dermatitis; consensus study; measurement; outcome domain; study endpoint; DISEASE-ACTIVITY; CLINICAL-TRIALS; SEVERITY SCORE; DERMATITIS; OMERACT; EFFICACY; PATIENT; SYSTEM; AREA; TOOL;

D O I：

10.1111/j.1398-9995.2012.02874.x

中图分类号：

R392 [医学免疫学];

学科分类号：

100108 [医学免疫学];

摘要：

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.

引用

页码：1111 / 1117

页数：7

共 26 条

[1]

Six area, six sign atopic dermatitis (SASSAD) severity score: A simple system for monitoring disease activity in atopic dermatitis [J].