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Towards global consensus on core outcomes for hidradenitis suppurativa research: an update from the HISTORIC
L Thorlacius1,2, A Garg3, J R Ingram4
1Department of Dermatology, Zealand University Hospital, Roskilde, Health Sciences Faculty, University of Copenhagen, Denmark.
Insights
Researchers established seven core outcome domains for hidradenitis suppurativa (HS) clinical trials. This consensus ensures consistent measurement of HS outcomes in research.
Area of Science:
- Dermatology
- Clinical Trial Methodology
- Patient-Reported Outcomes
Background:
- Hidradenitis suppurativa (HS) lacks a standardized Core Outcome Set (COS) for clinical trials.
- Developing a COS is crucial for consistent outcome measurement in HS research.
- Previous work involved patient interviews, literature reviews, and healthcare professional surveys.
Purpose of the Study:
- To identify and cluster candidate outcome items into meaningful domains for an HS COS.
- To exclude irrelevant items from the long list of potential outcomes.
- To ensure an inclusive and consensus-driven approach to domain generation.
Main Methods:
- An international, multistakeholder approach involving patients and healthcare professionals.
- Two in-person consensus meetings utilizing nominal group theory and presentations.
- A subsequent online confirmation survey to validate findings.
Main Results:
- Forty-one international participants contributed to the consensus process.
- Nine items were excluded, and seven core outcome domains were proposed.
- The proposed domains include disease course, physical signs, quality of life, satisfaction, symptoms, pain, and global assessments.
Conclusions:
- The HISTORIC consensus meetings successfully generated a proposed set of core outcome domains for HS.
- Further e-Delphi rounds are planned to finalize the HS COS.
- This work represents a significant step towards standardized outcome measurement in HS clinical trials.
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.
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