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

Chalmers, J. R., Schmitt, J., Apfelbacher, C., Dohil, M., Eichenfield, L. F., Simpson, E. L., Singh, J., Spuls, P., Thomas, K. S., Admani, S., Aoki, V., Ardeleanu, M., Barbarot, S., Berger, T., Bergman, J. N., Block, J., Borok, N., Burton, T., Chamlin, S. L., Deckert, S., Deklotz, C. C., Graff, L. B., Hanifin, J. M., Hebert, A. A., Humphreys, R., Katoh, N., Kisa, R. M., Margolis, D. J., Merhand, S., Minnillo, R., Mizutani, H., Nankervis, H., Ohya, Y., Rodgers, P., Schram, M. E., Stalder, J. F., Svensson, A., Takaoka, R., Teper, A., Tom, W. L., Von Kobyletzki, L., Weisshaar, E., Zelt, S., Williams, H. C.

British Journal of Dermatology. 2014; 171(6):1318-1325


Abstract

This 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. © 2014 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.


Read More on PubMed