A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process

Br J Dermatol. 2018 Sep;179(3):642-650. doi: 10.1111/bjd.16672. Epub 2018 Jul 5.

Abstract

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 synthesize evidence.

Objectives: To achieve global multistakeholder 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 that 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 to healthcare 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 HCPs 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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Clinical Trials as Topic / standards*
  • Consensus
  • Delphi Technique*
  • Disease Progression
  • Hidradenitis Suppurativa / complications
  • Hidradenitis Suppurativa / therapy*
  • Humans
  • International Cooperation
  • Patient Reported Outcome Measures*
  • Qualitative Research
  • Quality of Life
  • Treatment Outcome