title: Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.
abstract: OBJECTIVE
  This article describes the core outcome set (COS) for atopic eczema trials.
  
  
  RESULTS
  COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway.
  
  
  CONCLUSIONS
  Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.
authors.affiliation: aCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK bCenter for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany *Eric L. Simpson, Department of Dermatology, Oregon Health and Sciences University, Portland, Oregon, USA; Phyllis I. Spuls, Department of Dermatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands; Christian Apfelbacher, Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Bavaria, Germany; Kim S. Thomas, Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK; Masutaka Furue, Department of Dermatology, Kyushu University, Fukuoka, Japan; Hywel C. Williams, Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Chalmers
authors.forename: Stefanie
authors.initials: S
authors.lastname: Deckert
authors.forename: Jochen
authors.initials: J
authors.lastname: Schmitt
mesh_terms: D002986:Clinical Trials as Topic; D003876:Dermatitis, Atopic / Q000473:pathology / Q000628:therapy*; D006801:Humans; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome