Towards global consensus on core outcomes for Hidradenitis Suppurativa research: An update from the HISTORIC consensus meetings I and II

Abstract

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 literature and a health care professionals (HCPs) 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

The main objectives were 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 multi-stakeholder approach, involving patients, dermatologist, 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

41 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 assessment.

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.

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