. 2018 Mar;178(3):715-721.

doi: 10.1111/bjd.16093. Epub 2018 Feb 1.

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

L Thorlacius^{1

2}, A Garg³, J R Ingram⁴, B Villumsen⁵, P Theut Riis¹, A B Gottlieb⁶, J F Merola^{7

8}, R Dellavalle⁹, C Ardon¹⁰, R Baba¹¹, F G Bechara¹², A D Cohen^{13

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-Miller^{33

34

35}, E P Prens⁹, S Randell²², C Rogers³⁶, C F Rosen³⁷, S E Choon³⁸, H H van der Zee^{9

39}, R Christensen², G B E Jemec¹

Affiliations

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.

PMID: 29080368
PMCID: PMC5935265
DOI: 10.1111/bjd.16093

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

L Thorlacius et al. Br J Dermatol. 2018 Mar.

. 2018 Mar;178(3):715-721.

doi: 10.1111/bjd.16093. Epub 2018 Feb 1.

Authors

Affiliations

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.

PMID: 29080368
PMCID: PMC5935265
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.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest: L.T., J.R.I., F.G.B., L.E., J.S.K., L.M., E.P.P., H.H.vdZ. and G.B.E.J. are or have been involved in the development of instruments that could potentially be used to measure core outcomes for hidradenitis. However, specific instruments were not discussed.

Figures

**Fig 1**
Summary of the hidradenitis suppurativa core domain development process, highlighting (circle) the part described in this study. HCP, healthcare professional.

**Fig 2**
Summary of the study procedures. COS, core outcomes set.

See this image and copyright information in PMC

Comment in

By using a core outcome set we measure what matters to patients.
Prinsen CAC, Spuls PI, Terwee CB. Prinsen CAC, et al. Br J Dermatol. 2018 Mar;178(3):579-580. doi: 10.1111/bjd.16273. Br J Dermatol. 2018. PMID: 29595219 No abstract available.

References

1. Jemec GB. Clinical practice Hidradenitis suppurativa. N Engl J Med. 2012;366:158–64. - PubMed
1. Zouboulis CC, Del Marmol V, Mrowietz U, et al. Hidradenitis suppurativa/acne inversa: criteria for diagnosis, severity assessment, classification and disease evaluation. Dermatology (Basel) 2015;231:184–90. - PubMed
1. Jemec GB, Heidenheim M, Nielsen NH. The prevalence of hidradenitis suppurativa and its potential precursor lesions. J Am Acad Dermatol. 1996;35:191–4. - PubMed
1. Revuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with hidradenitis suppurativa: results from two case–control studies. J Am Acad Dermatol. 2008;59:596–601. - PubMed
1. Vinding GR, Miller IM, Zarchi K, et al. The prevalence of inverse recurrent suppuration: a population-based study of possible hidradenitis suppurativa. Br J Dermatol. 2014;170:884–9. - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

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Medical

Miscellaneous