Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

Abstract

SummaryThis report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure.What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient-reported symptoms, long-term control and health-related quality of life. What does this study add? Progress was made towards developing a core outcome set for measuring eczema in clinical trials. The group established the essential items to be included in the outcome measure for the clinical signs of eczema and was able to recommend a scale for the core set. The remaining three domains of patient-reported symptoms, long-term control and health-related quality of life require further work and meetings to determine the core outcome measures.

Report from the kick-off meeting of the Cochrane Skin Group Core Outcome Set Initiative (CSG-COUSIN)

“…Professor Hywel Williams then highlighted the relevance and urgent need for a COS in eczema trials because of the high heterogeneity of existing trial outcomes, with many outcome measurement instruments not tested at all. He referred to further COSs and methodological initiatives in other medical fields such as the Outcome Measures in Rheumatology (OMERACT) (http://www.omeract.org), the Consensus‐based Standards for the selection of Health measurement Instruments (COSMIN) group (http://www.cosmin.nl) and the Core Outcome Measures in Effectiveness Trials (COMET) Initiative (http://www.comet-initiative.org), which have already developed general guidance, methodological approaches or recommendations for the selection of outcomes and outcome measurement instruments to be included in a COS. Based on the described barrier towards evidence‐based decision making in eczema, he summarized milestones of the work of the HOME initiative that developed a consensus‐based set of core outcomes for eczema for inclusion in all clinical trials . He then explained the HOME roadmap, which describes the steps that need to be followed when developing a COS, and how it might be applied by other groups developing COSs for the other skin diseases.…”

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

“…The HOME roadmap was developed by the HOME executive board as a methodological framework on how to develop a core set of outcome measurement instruments [21 & ]. This was followed by a number of research projects to inform discussions at the working meetings HOME II in 2011 [22] and HOME III in 2013 [23]. Details of each stage are described in more detail in the sections that follow.…”

“…San Diego, California, USA Working meeting (HOME III) in which consensus was reached that EASI would be recommended as the core outcome measure for capturing clinician-reported signs [23] 2015 Malmö, Sweden Working meeting (HOME VI) will move towards recommending core outcome measures for capturing patient-reported outcomes EASI, Eczema Area and Severity Index; HOME, Harmonising Outcomes Measures for Eczema.…”

“…A total of 56 individuals (representing patients, clinicians, methodologists, and the pharmaceutical [23]. The priority topic for this working meeting was clinician-reported signs.…”

8th Georg Rajka International Symposium on Atopic Dermatitis: meeting report

“…Definitions of early AD, disease flares and long‐term control are lacking, and outcome measures are even harder to define. The HOME collaboration is working to identify instruments to measure the core outcomes domains for inclusion in all AD trials using a systematic approach …”