Core Outcome Measures in Effectiveness Trials

Towards global consensus on core outcomes for hidradenitis suppurativa research: an update from the HISTORIC consensus meetings I and II

General Information

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 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.

Authors:
Thorlacius, L. Garg, A. Ingram, J. R. Villumsen, B. Theut Riis, P. Gottlieb, A. B. Merola, J. F. Dellavalle, R. Ardon, C. Baba, R. Bechara, F. G. Cohen, A. D. Daham, N. Davis, M. Emtestam, L. Fernandez-Penas, P. Filippelli, M. Gibbons, A. Grant, T. Guilbault, S. Gulliver, S. Harris, C. Harvent, C. Houston, K. Kirby, J. S. Matusiak, L. Mehdizadeh, A. Mojica, T. Okun, M. Orgill, D. Pallack, L. Parks-Miller, A. Prens, E. P. Randell, S. Rogers, C. Rosen, C. F. Choon, S. E. van der Zee, H. H. Christensen, R. Jemec, G. B. E.

Publication

Journal:
Br J Dermatol
Volume:
178
Issue:
3
Pages:
715 - 721
Year:
2018
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Skin

Disease Name
Hidradenitis Suppurativa

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting

Stakeholders Involved

Unknown

Study Type

Unknown

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