The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials - 02/10/14
, Phyllis I. Spuls, MD, PhD b, Kim S. Thomas, PhD c, Eric Simpson, MD d, Masutaka Furue, MD e, Stefanie Deckert, MPH a, Magdalene Dohil, MD f, Christian Apfelbacher, PhD g, Jasvinder A. Singh, MD h, Joanne Chalmers, PhD c, Hywel C. Williams, DSc con behalf of the
HOME initiative collaborators∗
Abstract |
The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care.
Le texte complet de cet article est disponible en PDF.Key words : Atopic dermatitis, clinical trials, eczema, Eczema Area and Severity Index, evidence-based medicine, outcomes research
Abbreviations used : AE, EASI, HOME, OMERACT, RCT, SASSAD, SCORAD, TIS
Plan
| This publication describes work conducted on behalf of the Harmonising Outcome Measures for Eczema (HOME) initiative that is supported through an independent research grant funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme funding scheme (RP-PG-0407-10177). The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service, the NIHR, or the Department of Health. |
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| Disclosure of potential conflict of interest: This study was funded by a grant from the National Institute of Health Research (RP-PG-0407-10177). P. I. Spuls has received consultancy fees from Leopharma, AbbVie, and Novartis; has received or has grants pending from Schering Plough and Leopharma; and has received payment for the development of educational presentations from AbbVie. C. Apfelbacher has received or has grants pending from Siemens Healthcare; has received payment for delivering lectures from Basilea Pharmaceutica; and has received compensation for travel and other meeting-related expenses from Stiefel and GlaxoSmithKline. J. A. Singh has received consultancy fees from Takeda, Savient, Regeneron and Allergan and has received or has grants pending from Takeda and Savient. J. Chalmers's institution has received a grant from the National Institute for Health Research (RP-PG-0407-10177). The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 134 - N° 4
P. 800-807 - octobre 2014 Retour au numéro
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