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Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema

Joanne Chalmers1, Stefanie Deckert, Jochen Schmitt

  • 1aCentre 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.

Current Opinion in Allergy and Clinical Immunology
|July 9, 2015
PubMed
Abstract

Insights

A core outcome set (COS) for atopic eczema trials standardizes outcome measures. This ensures comparability across studies by defining essential endpoints like clinical signs, quality of life, symptoms, and flares.

Area of Science:

  • Dermatology
  • Clinical Trials Methodology
  • Patient-Reported Outcomes

Background:

  • Inconsistent outcome measures in atopic eczema trials hinder comparability.
  • A need exists for standardized core outcome sets (COS) to improve research synthesis.

Purpose of the Study:

  • To describe the established core outcome set (COS) for atopic eczema clinical trials.
  • To outline the framework for developing and implementing COS in eczema research.

Main Methods:

  • Development of a generic framework by the Harmonising Outcomes Measures for Eczema initiative.
  • Selection of core outcome domains through systematic reviews and multi-stakeholder consensus.
  • Evaluation of outcome measurement instruments for validity, reliability, and feasibility.

Main Results:

  • Broad consensus identifies clinical signs, quality of life, symptoms, and flare control as core domains for atopic eczema COS.
  • The Eczema Area and Severity Index is recommended for assessing clinical signs.
  • Systematic reviews are ongoing to identify instruments for other core domains.

Conclusions:

  • Clinical signs must be assessed using the Eczema Area and Severity Index in all atopic eczema trials.
  • Quality of life, symptoms, and flares require assessment with valid, reliable, and feasible instruments.

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