Background—There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome reporting bias and limits the ability to synthesise evidence.
Objectives—To achieve global multi-stakeholder consensus on a Core Outcome Set (COS) of domains regarding what to measure in clinical trials for HS.
Methods—Six stakeholder groups participated in a Delphi process which included five anonymous e-Delphi rounds and four face-to-face consensus meetings to reach consensus on the final COS. The aim was for a 1:1 ratio of patients: Health Care Professionals (HCPs).
Results—A total of 41 patients and 52 HCPs from 19 countries in four continents participated in the consensus process which yielded a final COS that included five domains: pain, physical signs, HS specific quality of life, global assessment and progression of course. A sixth domain, symptoms, was highly supported by patients and not by healthcare professionals but is recommended for the core domain set.
Conclusions—Routine adoption of the COS in future HS trials should ensure that core outcomes of importance to both patients and HCPs are collected.
Linnea Thorlacius, John R Ingram, Amit Garg, Bente Villumsen, Solveig Esmann, Joslyn S Kirby, Alice B Gottlieb, Joseph F Merola, Robert Dellavalle, S M Nielsen, Robin Christensen, Amit Garg, Gregor B E Jemec
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Nominal group technique (NGT)
- Semi structured discussion
- Systematic review
An international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation.