L Thorlacius1,2,3, J R Ingram4, B Villumsen5, S Esmann1, J S Kirby6, A B Gottlieb7, J F Merola8,9,10, R Dellavalle11, S M Nielsen3, R Christensen3,12, A Garg13, G B E Jemec1,2. 1. Department of Dermatology, Zealand University Hospital, Roskilde, Denmark. 2. Health Sciences Faculty, University of Copenhagen, Copenhagen, Denmark. 3. Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. 4. Institute of Infection & Immunity, Cardiff University, University Hospital of Wales, Heath Park, Cardiff, U.K. 5. The Patients' Association HS Denmark, Copenhagen, Denmark. 6. Department of Dermatology, Penn State Hershey Medical Center, Hershey, PA, U.S.A. 7. Department of Dermatology, New York Medical College, Valhalla, NY, U.S.A. 8. Harvard Medical School, Boston, MA, U.S.A. 9. Department of Dermatology, Division of Rheumatology, Brigham and Women's Hospital, Boston, MA, U.S.A. 10. Department of Medicine, Division of Rheumatology, Brigham and Women's Hospital, Boston, MA, U.S.A. 11. Dermatology Service, US Department of Veteran Affairs Medical Centre, Denver, CO, U.S.A. 12. Department of Rheumatology, Odense University Hospital, Odense, Denmark. 13. Department of Dermatology, Hofstra Northwell School of Medicine, New Hyde Park, NY, U.S.A.
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.
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.
Authors: Gordon H Guyatt; Andrew D Oxman; Regina Kunz; David Atkins; Jan Brozek; Gunn Vist; Philip Alderson; Paul Glasziou; Yngve Falck-Ytter; Holger J Schünemann Journal: J Clin Epidemiol Date: 2010-12-30 Impact factor: 6.437
Authors: Jean E Revuz; Florence Canoui-Poitrine; Pierre Wolkenstein; Cedric Viallette; Germaine Gabison; Florence Pouget; Florence Poli; Ousmane Faye; Jean Claude Roujeau; Genevieve Bonnelye; Jean Jacques Grob; Sylvie Bastuji-Garin Journal: J Am Acad Dermatol Date: 2008-10 Impact factor: 11.527
Authors: Jochen Schmitt; Christian Apfelbacher; Phyllis I Spuls; Kim S Thomas; Eric L Simpson; Masutaka Furue; Joanne Chalmers; Hywel C Williams Journal: J Invest Dermatol Date: 2014-09-04 Impact factor: 8.551
Authors: Paula R Williamson; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; Peter Tugwell Journal: Trials Date: 2012-08-06 Impact factor: 2.279
Authors: Nicola L Harman; Iain A Bruce; Peter Callery; Stephanie Tierney; Mohammad Owaise Sharif; Kevin O'Brien; Paula R Williamson Journal: Trials Date: 2013-03-12 Impact factor: 2.279
Authors: J S Kirby; L Thorlacius; B Villumsen; J R Ingram; A Garg; K B Christensen; M Butt; S Esmann; J Tan; G B E Jemec Journal: Br J Dermatol Date: 2019-12-26 Impact factor: 9.302
Authors: Alison H Kohn; Afsaneh Alavi; April W Armstrong; Folawiyo Babalola; Amit Garg; Alice B Gottlieb; Lesley Grilli; Gregor Borut Ernst Jemec; John Latella; Kendall Marcus; Joseph F Merola; Alex G Ortega-Loayza; Daniel M Siegel; Vibeke Strand; Jerry K L Tan; Lourdes M Perez-Chada Journal: Dermatology Date: 2021-09-17 Impact factor: 5.197
Authors: Eran Shavit; Afsaneh Alavi; Falk G Bechara; Richard G Bennett; Marc Bourcier; Ricardo Cibotti; Steven Daveluy; John W Frew; Amit Garg; Iltefat Hamzavi; Lauren K Hoffman; Jenny Hsaio; Joslyn Sciacca Kirby; Hadar Lev-Tov; Erin Martinez; Robert Micheletti; Haley B Naik; Aude Nassif; Cynthia Nicholson; Angie Parks-Miller; Zarine Patel; Vincent Piguet; Mayur Ramesh; Barry Resnik; Christopher Sayed; Gregory Schultz; Aamir Siddiqui; Jerry Tan; Ximena Wortsman; Michelle A Lowes Journal: Exp Dermatol Date: 2019-01 Impact factor: 3.960
Authors: J S Kirby; B Hereford; L Thorlacius; B Villumsen; J R Ingram; A Garg; M Butt; S Esmann; T King; J Tan; G B E Jemec Journal: Br J Dermatol Date: 2020-09-03 Impact factor: 9.302