L Thorlacius1,2, A Garg3, J R Ingram4, B Villumsen5, P Theut Riis1, A B Gottlieb6, J F Merola7,8, R Dellavalle9, C Ardon10, R Baba11, F G Bechara12, A D Cohen13,14, N Daham15, M Davis16, L Emtestam17, P Fernández-Peñas18, M Filippelli19, A Gibbons20, T Grant21, S Guilbault22, S Gulliver23, C Harris24, C Harvent25, K Houston20, J S Kirby26, L Matusiak27, A Mehdizadeh28, T Mojica29, M Okun30, D Orgill31, L Pallack32, A Parks-Miller33,34,35, E P Prens9, S Randell22, C Rogers36, C F Rosen37, S E Choon38, H H van der Zee9,39, R Christensen2, G B E Jemec1. 1. Department of Dermatology, Zealand University Hospital, Roskilde, Health Sciences Faculty, University of Copenhagen, Denmark. 2. Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, the Capital Region of Denmark, Copenhagen, Denmark. 3. Department of Dermatology, Hofstra Northwell School of Medicine, New Hyde Park, NY, U.S.A. 4. Institute of Infection and Immunity, University Hospital of Wales, Heath Park, Cardiff, U.K. 5. Patient Representative, The Patients' Association HS Denmark, Denmark. 6. Department of Dermatology, New York Medical College, Valhalla, NY, U.S.A. 7. Harvard Medical School, Boston, MA, U.S.A. 8. Department of Dermatology and Department of Medicine, Division of Rheumatology. 9. Dermatology Service, U.S. Department of Veteran Affairs Medical Centre, Denver, CO, U.S.A. 10. Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands. 11. Former National Advisor to the Ministry of Health, Malaysia. 12. Department of Dermatologic Surgery, St Josef Hospital, Ruhr-University, Bochum, Germany. 13. Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. 14. Chief Physician's Office, Department of Quality Measurements and Research, Clalit Health Services, Tel-Aviv, Israel. 15. Department of Dermatology, Tufts Medical Center, Boston, MA, U.S.A. 16. Department of Dermatology, Mayo Clinic, Rochester, MN, 5590, U.S.A. 17. Department of Dermatology, Karolinska University Hospital, Stockholm, Sweden. 18. Department of Dermatology, Westmead Hospital, Sydney Medical School, The University of Sydney, Sydney, Australia. 19. Patient Representative, Morgantown, WV, U.S.A. 20. Patient Representatives, The Hidradenitis Suppurativa Trust, Rochester, U.K. 21. Patient Representative, Tucson, AZ, U.S.A. 22. Patient Representative, Hope for HS, Detroit, MI, U.S.A. 23. Department of Research, Newlab Clinical Research, NL, Canada. 24. Patient Representative, Cardiff, U.K. 25. Patient Representative, Patients' Association: La Maladie de Verneuil en Belgique, Erbisoeul, Belgium. 26. Department of Dermatology, Penn State Hershey Medical Center, Hershey, PA, U.S.A. 27. Department of Dermatology, Venereology and Allergology, Wrocław Medical University, Wrocław, Poland. 28. Dalla Lana School of Public Health, University of Toronto, ON, Canada. 29. Patient Representative, Brick, NJ, U.S.A. 30. Fort HealthCare, Fort Atkinson, WI, U.S.A. 31. Division of Plastic Surgery, Brigham and Women's Hospital, Boston, MA, U.S.A. 32. Patient Representative, Longmont, CO, U.S.A. 33. Hope for HS, Detroit, MI, U.S.A. 34. Hidradenitis Suppurativa Foundation, Inc., Santa Monica, CA, U.S.A. 35. Department of Dermatology, Henry Ford Hospital, Detroit, MI, U.S.A. 36. Patient Representative, HS Aware, Toronto, ON, Canada. 37. Division of Dermatology, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada. 38. Department of Dermatology, Hospital Sultanah Aminah, Johor Bahru, Malaysia. 39. Department of Dermatology, Havenziekenhuis, Rotterdam, the Netherlands.
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.
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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