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.
|Persistent URL||dx.doi.org/10.1111/bjd.16093, hdl.handle.net/1765/111336|
|Journal||British Journal of Dermatology|
Thorlacius, L. (L.), Garg, A. (A.), Ingram, J.R. (J. R.), Villumsen, B. (B.), Theut Riis, P. (P.), Gottlieb, A.B. (A. B.), … Jemec, G.B.E. (2018). Towards global consensus on core outcomes for hidradenitis suppurativa research: an update from the HISTORIC consensus meetings I and II. In British Journal of Dermatology (Vol. 178, pp. 715–721). doi:10.1111/bjd.16093