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Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).
Chalmers, J R; Simpson, E; Apfelbacher, C J; Thomas, K S; von Kobyletzki, L; Schmitt, J; Singh, J A; Svensson, Å; 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; Creswell-Melville, A; Dinesen, M; Drucker, A; Eckert, L; Flohr, C; Garg, M; Gerbens, L A A; Graff, A L B; Hanifin, J; Heinl, D; Humphreys, R; Ishii, H A; Kataoka, Y; Leshem, Y A; Marquort, B; Massuel, M-A; Merhand, S; Mizutani, H; Murota, H; Murrell, D F; Nakahara, T; Nasr, I; Nograles, K; Ohya, Y; Osterloh, I; Pander, J; Prinsen, C; Purkins, L; Ridd, M; Sach, T; Schuttelaar, M-L A.
Affiliation
  • 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.
  • Schmitt J; Department of Public Health Sciences, Karlstad University, Karlstad, Sweden.
  • Singh JA; Centre for Evidence-Based Healthcare, University of Dresden, Dresden, Germany.
  • Svensson Å; Department of Occupational and Social Medicine, Technical University Dresden, Dresden, Germany.
  • Williams HC; Medicine Service, Birmingham VA Medical Center, Birmingham, AL, U.S.A.
  • Abuabara K; Department of Medicine, University of Alabama, Birmingham, AL, U.S.A.
  • Aoki V; Department of Dermatology and Venereology, Malmö University Hospital, Malmö, Sweden.
  • Ardeleanu M; Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.
  • Awici-Rasmussen M; Department of Dermatology, University of California San Francisco, San Francisco, California, CA, U.S.A.
  • Barbarot S; Department of Dermatology, University of São Paulo Medical School, São Paulo, Brazil.
  • Berents TL; Immunology and Inflammation, Regeneron Pharmaceuticals, Inc., New York, NY, U.S.A.
  • Block J; Psoriasis and Eczema Association of Norway, Oslo, Norway.
  • Bragg A; Department of Dermatology, CHU de Nantes, Nantes, France.
  • Burton T; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
  • Bjerring Clemmensen KK; Department of Dermatology, Oslo University Hospital, Oslo, Norway.
  • Creswell-Melville A; National Eczema Organisation, National Eczema Association, San Rafael, CA, U.S.A.
  • Dinesen M; Chugai Pharma Europe Ltd., London, U.K.
  • Drucker A; No affiliation (patient representative U.K.).
  • Eckert L; Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Flohr C; Société Canadienne de l'Eczéma, Keswick, ON, Canada.
  • Garg M; LEO Pharma A/S, Industriparken 55, Ballerup, Denmark.
  • Gerbens LA; Division of Dermatology, University Health Network, Toronto, ON, Canada.
  • Graff AL; Health Economics and Outcomes Research, Sanofi, France.
  • Hanifin J; St John's Institute of Dermatology, Guy's and St Thomas' Hospitals NHS Foundation Trust and King's College London, London, U.K.
  • Heinl D; LEO Pharma, Copenhagen, Denmark.
  • Humphreys R; Department of Dermatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
  • Ishii HA; National Eczema Society, London, U.K.
  • Kataoka Y; Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A.
  • Leshem YA; Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
  • Marquort B; National Eczema Society, London, U.K.
  • Massuel MA; Brazilian Atopic Dermatitis Association (AADA), São Paulo, Brazil.
  • Merhand S; Osaka Prefectural Medical Center for Respiratory and Allergic Disease, Osaka, Japan.
  • Mizutani H; Department of Dermatology, Oregon Health and Science University, Portland, OR, U.S.A.
  • Murota H; No affiliation (patient representative Sweden).
  • Murrell DF; Sanofi-Aventis, Paris, France.
  • Nakahara T; Association Française de l'Eczéma, Redon, France.
  • Nasr I; Mie University, Graduate School of Medicine and Mie University Hospital Tsu, Mie, Japan.
  • Nograles K; Department of Dermatology, Osaka University, Osaka, Japan.
  • Ohya Y; Department of Dermatology, St George Hospital, Sydney, Australia.
  • Osterloh I; University of New South Wales, Sydney, Australia.
  • Pander J; Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
  • Prinsen C; Retired, no affiliation.
  • Purkins L; Celgene Corporation, Greater New York City Area Pharmaceuticals, New York, NY, U.S.A.
  • Ridd M; Division of Allergy, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
  • Sach T; Ostermed Ltd., Kent, U.K.
  • Schuttelaar ML; Celgene BV, Utrecht, the Netherlands.
Br J Dermatol ; 175(1): 69-79, 2016 Jul.
Article in En | MEDLINE | ID: mdl-27436240
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.
Subject(s)

Full text: 1 Database: MEDLINE Main subject: Dermatitis, Atopic Type of study: Guideline / Prognostic_studies Limits: Humans Language: En Journal: Br J Dermatol Year: 2016 Type: Article

Full text: 1 Database: MEDLINE Main subject: Dermatitis, Atopic Type of study: Guideline / Prognostic_studies Limits: Humans Language: En Journal: Br J Dermatol Year: 2016 Type: Article