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

Thorlacius L 1 , Garg A 2 , Ingram JR 3 , Villumsen B 4 , Theut Riis P 1 , Gottlieb AB 5 Show all authors , Merola JF 6 , Dellavalle R 7 , Ardon C 8 , Baba R 9 , Bechara FG 10 , Cohen AD 11 , Daham N 12 , Davis M 13 , Emtestam L 14 , Fernández-Peñas P 15 , Filippelli M 16 , Gibbons A 17 , Grant T 18 , Guilbault S 19 , Gulliver S 20 , Harris C 21 , Harvent C 22 , Houston K 17 , Kirby JS 23 , Matusiak L 24 , Mehdizadeh A 25 , Mojica T 26 , Okun M 27 , Orgill D 28 , Pallack L 29 , Parks-Miller A 30 , Prens EP 7 , Randell S 19 , Rogers C 31 , Rosen CF 32 , Choon SE 33 , van der Zee HH 7 , Christensen R 34 , Jemec GBE 1

Affiliations 

  • 1 Department of Dermatology, Zealand University Hospital, Roskilde, Health Sciences Faculty, University of Copenhagen, Denmark
  • 2 Department of Dermatology, Hofstra Northwell School of Medicine, New Hyde Park, NY, U.S.A
  • 3 Institute of Infection and Immunity, University Hospital of Wales, Heath Park, Cardiff, U.K
  • 4 Patient Representative, The Patients' Association HS Denmark, Denmark
  • 5 Department of Dermatology, New York Medical College, Valhalla, NY, U.S.A
  • 6 Harvard Medical School, Boston, MA, U.S.A
  • 7 Dermatology Service, U.S. Department of Veteran Affairs Medical Centre, Denver, CO, U.S.A
  • 8 Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands
  • 9 Former National Advisor to the Ministry of Health, Malaysia
  • 10 Department of Dermatologic Surgery, St Josef Hospital, Ruhr-University, Bochum, Germany
  • 11 Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
  • 12 Department of Dermatology, Tufts Medical Center, Boston, MA, U.S.A
  • 13 Department of Dermatology, Mayo Clinic, Rochester, MN, 5590, U.S.A
  • 14 Department of Dermatology, Karolinska University Hospital, Stockholm, Sweden
  • 15 Department of Dermatology, Westmead Hospital, Sydney Medical School, The University of Sydney, Sydney, Australia
  • 16 Patient Representative, Morgantown, WV, U.S.A
  • 17 Patient Representatives, The Hidradenitis Suppurativa Trust, Rochester, U.K
  • 18 Patient Representative, Tucson, AZ, U.S.A
  • 19 Patient Representative, Hope for HS, Detroit, MI, U.S.A
  • 20 Department of Research, Newlab Clinical Research, NL, Canada
  • 21 Patient Representative, Cardiff, U.K
  • 22 Patient Representative, Patients' Association: La Maladie de Verneuil en Belgique, Erbisoeul, Belgium
  • 23 Department of Dermatology, Penn State Hershey Medical Center, Hershey, PA, U.S.A
  • 24 Department of Dermatology, Venereology and Allergology, Wrocław Medical University, Wrocław, Poland
  • 25 Dalla Lana School of Public Health, University of Toronto, ON, Canada
  • 26 Patient Representative, Brick, NJ, U.S.A
  • 27 Fort HealthCare, Fort Atkinson, WI, U.S.A
  • 28 Division of Plastic Surgery, Brigham and Women's Hospital, Boston, MA, U.S.A
  • 29 Patient Representative, Longmont, CO, U.S.A
  • 30 Hope for HS, Detroit, MI, U.S.A
  • 31 Patient Representative, HS Aware, Toronto, ON, Canada
  • 32 Division of Dermatology, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada
  • 33 Department of Dermatology, Hospital Sultanah Aminah, Johor Bahru, Malaysia
  • 34 Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, the Capital Region of Denmark, Copenhagen, Denmark
Br J Dermatol, 2018 03;178(3):715-721.
PMID: 29080368 DOI: 10.1111/bjd.16093

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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