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

被引:88
作者
Chalmers, J. R. [1 ]
Schmitt, J. [2 ]
Apfelbacher, C. [3 ]
Dohil, M. [4 ]
Eichenfield, L. F. [4 ]
Simpson, E. L. [5 ]
Singh, J. [6 ,7 ]
Spuls, P. [8 ]
Thomas, K. S. [1 ]
Admani, S. [4 ]
Aoki, V. [9 ]
Ardeleanu, M. [10 ]
Barbarot, S. [11 ]
Berger, T. [12 ]
Bergman, J. N. [13 ]
Block, J. [14 ]
Borok, N. [4 ]
Burton, T. [1 ]
Chamlin, S. L. [15 ]
Deckert, S. [2 ]
DeKlotz, C. C. [4 ]
Graff, L. B. [16 ]
Hanifin, J. M. [5 ]
Hebert, A. A. [17 ]
Humphreys, R. [18 ]
Katoh, N. [19 ]
Kisa, R. M. [20 ]
Margolis, D. J. [21 ]
Merhand, S. [22 ]
Minnillo, R. [23 ]
Mizutani, H. [24 ]
Nankervis, H. [1 ]
Ohya, Y. [25 ]
Rodgers, P. [26 ]
Schram, M. E. [8 ]
Stalder, J. F. [27 ]
Svensson, A. [28 ]
Takaoka, R. [9 ]
Teper, A. [29 ]
Tom, W. L. [4 ]
von Kobyletzki, L. [30 ]
Weisshaar, E. [31 ]
Zelt, S. [32 ]
Williams, H. C. [1 ]
机构
[1] Univ Nottingham, Ctr Evidence Based Dermatol, Nottingham NG7 2RD, England
[2] Univ Dresden, Ctr Evidence Based Healthcare, Dresden, Germany
[3] Univ Regensburg, Dept Epidemiol & Prevent Med, D-93053 Regensburg, Germany
[4] Univ Calif San Diego, Rady Childrens Hosp, San Diego, CA 92103 USA
[5] Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA
[6] Univ Alabama Birmingham, Birmingham VA Med Ctr, Med Serv, Birmingham, AL USA
[7] Univ Alabama Birmingham, Dept Med, Birmingham, AL USA
[8] Univ Amsterdam, Acad Med Ctr, Dept Dermatol, NL-1105 AZ Amsterdam, Netherlands
[9] Univ Sao Paulo, Dept Dermatol, Sao Paulo, Brazil
[10] Regeneron Pharmaceut Inc, Immunol & Inflammat, Clin Sci, Tarrytown, NY 10591 USA
[11] CHU Nantes, Dept Dermatol, F-44035 Nantes 01, France
[12] Univ Calif San Francisco, Dept Dermatol, San Francisco, CA 94143 USA
[13] Univ British Columbia, Pediat Allergy & Dermatol Ctr, Vancouver, BC V5Z 1M9, Canada
[14] Natl Eczema Assoc, San Rafael, CA USA
[15] Ann & Robert H Lurie Childrens Hosp Chicago, Chicago, IL USA
[16] LEO Pharma AS, Ballerup, Denmark
[17] Univ Texas Houston, Sch Med, Dept Dermatol, Houston, TX USA
[18] Natl Eczema Soc, London, England
[19] Kyoto Prefectural Univ Med, Dept Dermatol, Kyoto, Japan
[20] Pierre Fabre Pharmaceut, New York, NY USA
[21] Univ Penn, Dept Dermatol, Philadelphia, PA 19104 USA
[22] French Assoc Eczema, Redon, France
[23] Soc Investigat Dermatol, Cleveland, OH USA
[24] Mie Univ, Dept Dermatol, Tsu, Mie 514, Japan
[25] Natl Ctr Child Hlth & Dev, Div Allergy, Tokyo, Japan
[26] LEO Pharma, Parsippany, NJ USA
[27] Nantes Univ Hosp, Dept Dermatol, Nantes, France
[28] Malmo Univ Hosp, Dept Dermatol, Malmo, Sweden
[29] Sanofi Aventis, Hastings On Hudson, NY USA
[30] Lund Univ, Dept Dermatol & Venerol, Lund, Sweden
[31] Univ Heidelberg Hosp, Dept Clin Social Med, Heidelberg, Germany
[32] Stiefel Labs, Res Triangle Pk, NC USA
基金
美国国家卫生研究院;
关键词
VARICELLA-ZOSTER VIRUS; EPIDERMOLYSIS-BULLOSA-ACQUISITA; MODIFYING ANTIRHEUMATIC DRUGS; HUMAN-IMMUNODEFICIENCY-VIRUS; STRONGYLOIDES-STERCORALIS; PEMPHIGUS-VULGARIS; AMERICAN-COLLEGE; HEPATITIS-C; IMMUNOSUPPRESSIVE THERAPY; FULMINANT-HEPATITIS;
D O I
10.1111/bjd.13237
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6-7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure.
引用
收藏
页码:1318 / 1325
页数:8
相关论文
共 105 条
[1]   Rituximab-related viral infections in lymphoma patients [J].
Aksoy, Sercan ;
Harputluoglu, Hakan ;
Kilickap, Saadettin ;
Dede, Didem Sener ;
Dizdar, Omer ;
Altundag, Kadri ;
Barista, Ibrahim .
LEUKEMIA & LYMPHOMA, 2007, 48 (07) :1307-1312
[2]  
Alter M.J., 2003, MMWR RECOMM REP, V52, P1
[3]  
[Anonymous], 2000, MMWR Recomm Rep, V49, P1
[4]  
[Anonymous], 2013, MMWR-MORBID MORTAL W, V62, P489
[5]  
[Anonymous], 2012, STRONG RES HLTH PROF
[6]  
[Anonymous], 2012, PREV HEP B SURF ANT
[7]  
[Anonymous], 2012, STRONG EP RISK FACT
[8]  
[Anonymous], 2013, INT J DERMA IN PRESS
[9]   Varicella zoster virus-associated disease in adult kidney transplant recipients: incidence and risk-factor analysis [J].
Arness, T. ;
Pedersen, R. ;
Dierkhising, R. ;
Kremers, W. ;
Patel, R. .
TRANSPLANT INFECTIOUS DISEASE, 2008, 10 (04) :260-268
[10]  
Azira NMS, 2010, TROP BIOMED, V27, P115