Outcome Measures for the Evaluation of Treatment Response in Hidradenitis Suppurativa for Clinical Practice: A HiSTORIC Consensus Statement

Mastacouris N 1 , Tannenbaum R 1 , Strunk A 1 , Koptyev J 1 , Aarts P 2 , Alhusayen R 3 Show all authors , Bechara FG 4 , Benhadou F 5 , Bettoli V 6 , Brassard A 7 , Brown D 8 , Choon SE 9 , Coutts P 10 , da Silva DLF 11 , Daveluy S 12 , Dellavalle RP 13 , Del Marmol V 14 , Emtestam L 15 , Gebauer K 16 , George R 17 , Giamarellos-Bourboulis EJ 18 , Goldfarb N 19 , Hamzavi I 20 , Hazen PG 21 , Horváth B 22 , Hsiao J 23 , Ingram JR 24 , Jemec GBE 25 , Kirby JS 26 , Lowes MA 27 , Marzano AV 28 , Matusiak L 29 , Naik HB 30 , Okun MM 31 , Oon HH 32 , Orenstein LAV 33 , Paek SY 34 , Pascual JC 35 , Fernandez-Peñas P 36 , Resnik BI 37 , Sayed CJ 38 , Thorlacius L 25 , van der Zee HH 2 , van Straalen KR 2 , Garg A 1

Affiliations 

  • 1 Northwell Health, New Hyde Park, New York
  • 2 Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands
  • 3 Sunnybrook Research Institute, Division of Dermatology, University of Toronto, Toronto, Ontario, Canada
  • 4 Department of Dermatology, Venereology and Allergology, Ruhr-University, Bochum, Germany
  • 5 Department of Dermatology, Hôpital Universitaire de Bruxelles, CUB Hôpital Erasme, Université libre de Bruxelles, Brussels, Belgium
  • 6 Department of Medical Sciences, O.U. of Dermatology, Azienda Ospedaliera, University of Ferrara, Ferrara, Italy
  • 7 University of California, Davis, Sacramento, California
  • 8 Medical Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
  • 9 Hospital Sultanah Aminah and Clinical School Johor Bahru, Monash University Malaysia, Johor Bahru, Malaysia
  • 10 Independent Consultant
  • 11 University Santo Amaro, São Paulo, Brazil
  • 12 Department of Dermatology, Wayne State University, Detroit, Michigan
  • 13 Department of Dermatology, University of Colorado Anschutz School of Medicine, Aurora, Colorado
  • 14 Department of Dermatology, Erasme Hospital, Universite Libre de Bruxelles, Brussels, Belgium
  • 15 Section of Infectious Diseases and Dermatology, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden
  • 16 University of Western Australia, Perth, Western Australia, Australia
  • 17 Department of Surgery, University of Toronto, Toronto, Ontario, Canada
  • 18 Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece
  • 19 Departments of Medicine and Dermatology, University of Minnesota, Minneapolis, Minnesota
  • 20 Department of Dermatology, Henry Ford Health System, Detroit, Michigan
  • 21 Case-Western Reserve University School of Medicine, Cleveland, Ohio
  • 22 Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
  • 23 Department of Dermatology, University of Southern California, Los Angeles
  • 24 Division of Infection and Immunity, Cardiff University, Cardiff, United Kingdom
  • 25 Department of Dermatology, Zealand University Hospital, Roskilde, Denmark
  • 26 Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania
  • 27 The Rockefeller University, New York, New York
  • 28 Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
  • 29 Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland
  • 30 Department of Dermatology, University of California, San Francisco
  • 31 Fort HealthCare, Fort Atkinson, Wisconsin
  • 32 National Skin Centre, Singapore, Singapore City, Singapore
  • 33 Department of Dermatology, Emory University School of Medicine, Atlanta, Georgia
  • 34 Baylor University Medical Center, Dallas, Texas A&M University School of Medicine, Dallas
  • 35 Dermatology Department, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research, Alicante, Spain
  • 36 Department of Dermatology, Westmead Hospital, The University of Sydney, Westmead, New South Wales, Australia
  • 37 Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida
  • 38 Department of Dermatology, University of North Carolina School of Medicine, Chapel Hill
JAMA Dermatol, 2023 Nov 01;159(11):1258-1266.
PMID: 37755725 DOI: 10.1001/jamadermatol.2023.3282

Abstract

IMPORTANCE: Although several clinician- and patient-reported outcome measures have been developed for trials in hidradenitis suppurativa (HS), there is currently no consensus on which measures are best suited for use in clinical practice. Identifying validated and feasible measures applicable to the practice setting has the potential to optimize treatment strategies and generate generalizable evidence that may inform treatment guidelines.

OBJECTIVE: To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied.

EVIDENCE REVIEW: Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice.

FINDINGS: Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]).

CONCLUSIONS AND RELEVANCE: An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.

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

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