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

Autor: Chalmers JR; Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K., Simpson E; Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A., Apfelbacher CJ; Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany., Thomas KS; Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K., von Kobyletzki L; Lund University, Skåne University Hospital, Department of Dermatology, Malmö, Sweden.; Department of Public Health Sciences, Karlstad University, Karlstad, Sweden., Schmitt J; Centre for Evidence-Based Healthcare, University of Dresden, Dresden, Germany.; Department of Occupational and Social Medicine, Technical University Dresden, Dresden, Germany., Singh JA; Medicine Service, Birmingham VA Medical Center, Birmingham, AL, U.S.A.; Department of Medicine, University of Alabama, Birmingham, AL, U.S.A., Svensson Å; Department of Dermatology and Venereology, Malmö University Hospital, Malmö, Sweden., Williams HC; Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K., Abuabara K; Department of Dermatology, University of California San Francisco, San Francisco, California, CA, U.S.A., Aoki V; Department of Dermatology, University of São Paulo Medical School, São Paulo, Brazil., Ardeleanu M; Immunology and Inflammation, Regeneron Pharmaceuticals, Inc., New York, NY, U.S.A., Awici-Rasmussen M; Psoriasis and Eczema Association of Norway, Oslo, Norway., Barbarot S; Department of Dermatology, CHU de Nantes, Nantes, France., Berents TL; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Dermatology, Oslo University Hospital, Oslo, Norway., Block J; National Eczema Organisation, National Eczema Association, San Rafael, CA, U.S.A., Bragg A; Chugai Pharma Europe Ltd., London, U.K., Burton T; No affiliation (patient representative U.K.)., Bjerring Clemmensen KK; Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark., Creswell-Melville A; Société Canadienne de l'Eczéma, Keswick, ON, Canada., Dinesen M; LEO Pharma A/S, Industriparken 55, Ballerup, Denmark., Drucker A; Division of Dermatology, University Health Network, Toronto, ON, Canada., Eckert L; Health Economics and Outcomes Research, Sanofi, France., Flohr C; St John's Institute of Dermatology, Guy's and St Thomas' Hospitals NHS Foundation Trust and King's College London, London, U.K., Garg M; LEO Pharma, Copenhagen, Denmark., Gerbens LA; Department of Dermatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands., Graff AL; National Eczema Society, London, U.K., Hanifin J; Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A., Heinl D; Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany., Humphreys R; National Eczema Society, London, U.K., Ishii HA; Brazilian Atopic Dermatitis Association (AADA), São Paulo, Brazil., Kataoka Y; Osaka Prefectural Medical Center for Respiratory and Allergic Disease, Osaka, Japan., Leshem YA; Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A., Marquort B; No affiliation (patient representative Sweden)., Massuel MA; Sanofi-Aventis, Paris, France., Merhand S; Association Française de l'Eczéma, Redon, France., Mizutani H; Mie University, Graduate School of Medicine and Mie University Hospital Tsu, Mie, Japan., Murota H; Department of Dermatology, Osaka University, Osaka, Japan., Murrell DF; Department of Dermatology, St George Hospital, Sydney, Australia.; University of New South Wales, Sydney, Australia., Nakahara T; Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Nasr I; Retired, no affiliation., Nograles K; Celgene Corporation, Greater New York City Area Pharmaceuticals, New York, NY, U.S.A., Ohya Y; Division of Allergy, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan., Osterloh I; Ostermed Ltd., Kent, U.K., Pander J; Celgene BV, Utrecht, the Netherlands., Prinsen C; Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands., Purkins L; Ziarco Pharma Ltd, Kent, U.K., Ridd M; School of Social & Community Medicine, University of Bristol, Bristol, U.K., Sach T; Health Economics Group, University of East Anglia, Norwich, U.K., Schuttelaar ML; Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands., Shindo S; Department of Dermatology, Osaka University, Osaka, Japan., Smirnova J; Department of Public Health Sciences, Karlstad University, Karlstad, Sweden., Sulzer A; Sanofi-Aventis, Montpellier, France., Synnøve Gjerde E; Psoriasis and Eczema Association of Norway, Oslo, Norway., Takaoka R; Department of Dermatology, University of São Paulo Medical School, São Paulo, Brazil., Vestby Talmo H; Sanofi-Aventis, Montpellier, France., Tauber M; Toulouse University, Toulouse, France., Torchet F; Mie University, Graduate School of Medicine and Mie University Hospital Tsu, Mie, Japan., Volke A; Department of Dermatology, University of Tartu, Tartu, Estonia., Wahlgren CF; Dermatology Unit, Department of Medicine, Karolinska Institutet, Solna, Sweden.; Karolinska University Hospital, Stockholm, Sweden., Weidinger S; Department of Dermatology, Venereology and Allergy University Hospital Schleswig-Holstein, Kiel, Germany., Weisshaar E; Occupational and Environmental Dermatology, Department of Social Medicine, University of Heidelberg, Heidelberg, Germany., Wollenberg A; Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany., Yamaga K; Department of Dermatology, Osaka University, Osaka, Japan., Zhao CY; Department of Dermatology, St George Hospital, Sydney, Australia.; University of New South Wales, Sydney, Australia., Spuls PI; Department of Dermatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Jazyk: angličtina
Zdroj: The British journal of dermatology [Br J Dermatol] 2016 Jul; Vol. 175 (1), pp. 69-79. Date of Electronic Publication: 2016 Jul 19.
DOI: 10.1111/bjd.14773
Abstrakt: 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.
(© 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)
Databáze: MEDLINE
Externí odkaz: