{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T01:03:05Z","timestamp":1792544585608,"version":"4.5.0"},"reference-count":17,"publisher":"American Medical Association (AMA)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"\n Importance<\/jats:title>\n Accurate classification and reliability in assessment for lesions of hidradenitis suppurativa (HS) by investigators is critical to the determination of responder status and to overall data quality in clinical trials.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To establish consensus-based morphological definitions of HS lesions and guidance statements that standardize investigator lesion assessments for implementation in clinical trials.<\/jats:p>\n <\/jats:sec>\n \n Evidence Review<\/jats:title>\n Health professionals (primarily dermatologists) with expertise in the measurement of HS disease activity as well as novice raters completed a preliminary questionnaire in which participants were asked to assess images of HS lesions and provide qualitative feedback on their decision making. Based on this feedback, detailed morphologic definitions for lesions and guidance statements that standardize lesion assessments were formulated and presented for consensus voting in 2 electronic Delphi surveys. A virtual group discussion after round 1 supported participants in round 2 voting.<\/jats:p>\n <\/jats:sec>\n \n Findings<\/jats:title>\n Response rates were 84.7% (50 of 59), 86.0% (43 of 50), and 90.9% (40 of 44) in the preliminary, electronic Delphi round 1, and electronic Delphi round 2 surveys, respectively. Morphological definitions for 11 lesion types achieved the prespecified 70% consensus threshold, with 9 definitions reaching at least 90% agreement. After 2 electronic Delphi rounds, 16 of 18 guidance statements achieved the prespecified consensus threshold, with 13 statements receiving endorsement from more than 80% of participants. Two guidance statements related to assessment of tunneled plaques with multiple openings and assessment of scalp lesions failed to reach consensus.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n Common morphologic definitions and guidance that standardize assessment of HS lesions can be implemented in clinical trial protocols and investigator trainings with the goals of improving accuracy and reliability of investigator ratings.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamadermatol.2025.4652","type":"journal-article","created":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T16:31:41Z","timestamp":1764174701000},"page":"72","source":"Crossref","is-referenced-by-count":5,"title":["Standardization of Lesion Classification and Assessment by Investigators in Clinical Trials for Hidradenitis Suppurativa"],"prefix":"10.1001","volume":"162","author":[{"given":"Amit","family":"Garg","sequence":"first","affiliation":[{"name":"Northwell, New Hyde Park, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Strunk","sequence":"additional","affiliation":[{"name":"Northwell, New Hyde Park, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bria","family":"Midgette","sequence":"additional","affiliation":[{"name":"Northwell, New Hyde Park, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Frasier","sequence":"additional","affiliation":[{"name":"Northwell, New Hyde Park, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Cohn","sequence":"additional","affiliation":[{"name":"Northwell, New Hyde Park, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pim","family":"Aarts","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Afsaneh","family":"Alavi","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raed","family":"Alhusayen","sequence":"additional","affiliation":[{"name":"Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bitte Falk G.","family":"Bechara","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University Hospital of the RWTH Aachen University, Aachen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Bettoli","sequence":"additional","affiliation":[{"name":"O.U. Dermatology, Azienda Ospedaliera, University of Ferrara, Ferrara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Brassard","sequence":"additional","affiliation":[{"name":"University of California Davis, Sacramento"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debra P.","family":"Brown","sequence":"additional","affiliation":[{"name":"Medical Ethics, Guy\u2019s and St Thomas\u2019 NHS Foundation Trust, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nisha Suyien","family":"Chandran","sequence":"additional","affiliation":[{"name":"National Skin Centre, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siew Eng","family":"Choon","sequence":"additional","affiliation":[{"name":"Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven R.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Weill Cornell Medical College, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Daveluy","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Wayne State University School of Medicine, Detroit, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronique","family":"del Marmol","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Universit\u00e9 Libre de Bruxelles, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert P.","family":"Dellavalle","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Minnesota, Minneapolis"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lennart","family":"Emtestam","sequence":"additional","affiliation":[{"name":"Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benhadou","family":"Farida","sequence":"additional","affiliation":[{"name":"H\u00f4pital Universitaire de Bruxelles, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"Fernandez-Penas","sequence":"additional","affiliation":[{"name":"Department of Dermatology, The University of Sydney, Westmead Hospital, Westmead, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. Hal","family":"Flowers","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Virginia, Charlottesville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John W.","family":"Frew","sequence":"additional","affiliation":[{"name":"University of New South Wales, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kurt A.","family":"Gebauer","sequence":"additional","affiliation":[{"name":"Fremantle Dermatology, Fremantle, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos J.","family":"Giamarellos-Bourboulis","sequence":"additional","affiliation":[{"name":"4th Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noah","family":"Goldfarb","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Minnesota, Minneapolis"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Horv\u00e1th","sequence":"additional","affiliation":[{"name":"University Medical Center Groningen, University of Groningen, Groningen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer L.","family":"Hsiao","sequence":"additional","affiliation":[{"name":"Keck School of Medicine, University of Southern California, Los Angeles"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregor","family":"Jemec","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Zealand University Hospital, Roskilde, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle A.","family":"Lowes","sequence":"additional","affiliation":[{"name":"The Rockefeller University, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo V.","family":"Marzano","sequence":"additional","affiliation":[{"name":"Dermatology Unit, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, Milan, Italy"},{"name":"Department of Pathophysiology and Transplantation, Universit\u00e0 degli Studi di Milano, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lukasz","family":"Matusiak","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venereology, and Clinical Immunology, Faculty of Medicine, Wroclaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert G.","family":"Micheletti","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Pennsylvania, Philadelphia"},{"name":"Department of Medicine, University of Pennsylvania, Philadelphia"},{"name":"Images in Dermatology, JAMA Dermatology"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hazel H.","family":"Oon","sequence":"additional","affiliation":[{"name":"National Skin Centre, Lee Kong Chian School of Medicine and Yong Loo Lin School of Medicine, National University of Singapore, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren A. V.","family":"Orenstein","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Emory University School of Medicine, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex G.","family":"Ortega-Loayza","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Oregon Health & Science University, Portland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"So Yeon","family":"Paek","sequence":"additional","affiliation":[{"name":"Baylor Scott & White, Dallas, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose C.","family":"Pascual","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Dr Balmis General University Hospital, ISABIAL, Alicante, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Piguet","sequence":"additional","affiliation":[{"name":"University of Toronto, Toronto, Ontario, 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Australia"},{"name":"Department of Dermatology, University of Santo Amaro (Unisa), S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linnea","family":"Thorlacius","sequence":"additional","affiliation":[{"name":"Zealand University Hospital and Parker Institute, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thrasyvoulos","family":"Tzellos","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University Hospital of North Norway, Troms\u00f8, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hessel","family":"van der Zee","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelsey","family":"van Straalen","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Erasmus University Medical Center, Rotterdam, 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