Towards Global Consensus on Core Outcomes for Hidradenitis Suppurativa Research: An Update from the HISTORIC Consensus Meetings I and II
BACKGROUND: A core outcomes set (COS) is an agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. Hidradenitis suppurativa (HS) has no agreed-upon COS. A central aspect in the COS development process is to identify a set of candidate outcome domains from a long list of items. Our long list had been developed from patient interviews, a systematic review of the literature and a healthcare professional survey, and initial votes had been cast in two e-Delphi surveys. In this manuscript, we describe two in-person consensus meetings of Delphi participants designed to ensure an inclusive approach to generation of domains from related items. OBJECTIVES: To consider which items from a long list of candidate items to exclude and which to cluster into outcome domains. METHODS: The study used an international and multistakeholder approach, involving patients, dermatologists, surgeons, the pharmaceutical industry and medical regulators. The study format was a combination of formal presentations, small group work based on nominal group theory and a subsequent online confirmation survey. RESULTS: Forty-one individuals from 13 countries and four continents participated. Nine items were excluded and there was consensus to propose seven domains: disease course, physical signs, HS-specific quality of life, satisfaction, symptoms, pain and global assessments. CONCLUSIONS: The HISTORIC consensus meetings I and II will be followed by further e-Delphi rounds to finalize the core domain set, building on the work of the in-person consensus meetings.
Thorlacius, L., Garg, A., Ingram, J., Villumsen, B., Theut Riis, P., Gottlieb, A., Merola, J., Dellavalle, R., & Jemec, G. (2018). Towards Global Consensus on Core Outcomes for Hidradenitis Suppurativa Research: An Update from the HISTORIC Consensus Meetings I and II. The British Journal of Dermatology, 178 (3), 715-721. https://doi.org/10.1111/bjd.16093