Condition
Hidradenitis suppurativa (HS)
Background
Outcome measures in HS are markedly heterogeneous with 30 instruments found in 12 randomized trials
Scope of the intended COS
- Study types: all clinical trials
- Region: global
Methods
Systematic review, patient interviews and an online survey of HS clinicians generated potential items for inclusion in the core domain set. This was followed by an e-Delphi process and four in-person consensus meetings between patients and clinicians to create the core domains.
Involvement of stakeholders
41 patients with HS and 52 clinicians participated in the consensus process
Current status
Six core domains have been defined: pain, physical signs, HS-specific quality of life, global assessment, disease progression, and symptoms. Parallel work groups are now considering instruments to measure each domain.
Funding
International Dermatology Outcome Measures (IDEOM) initiative kindly provide financial support
Involved Countries
19 countries in four continents
Date of updates
29/09/2019
Lead
- Dr John Ingram
Project team members
- Linnea Thorlacius
- Bente Villumsen
- Joslyn Kirby
- Robin Christensen
- Amit Garg
- Gregor Jemec
Responsible member of Methods group (as assigned by CS-COUSIN)
- Prof Kim Thomas
Contact
- Dr John Ingram (ingramjr@cardiff.ac.uk )
Published references
1. Thorlacius L, Garg A, Ingram JR, Villumsen B, Riis PT, Gottlieb AB, Merola JF, Dellavalle R, Ardon C, Baba R, Bechara FG, Cohen AD, 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 JS, Matusiak L, Mehdizadeh A, Mojica T, Okun M, Orgill D, Pallack L, Parks-Miller A, Prens EP, Randell S, Rogers C, Rosen CF, Choon SE, van der Zee HH, Christensen R, Jemec GBE. Towards global consensus on core outcomes for hidradenitis suppurativa research: an update from the HISTORIC consensus meetings I and II. Brit J Dermatol. 2018;178(3):715-721.
2. Thorlacius L, Ingram JR, Garg A, Villumsen B, Esmann S, Kirby JS, Gottlieb AB, Merola JF, Dellavalle R, Christensen R, Jemec GBE. Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes. Bmj Open. 2017;7(2).
3. Thorlacius L, Ingram JR, Villumsen B, Esmann S, Kirby JS, Gottlieb AB, Merola JF, Dellavalle R, Nielsen SM, Christensen R, Garg A, Jemec GBE, cORe HST. A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process. Brit J Dermatol. 2018;179(3):642-650.