Standardization of lesion classification and assessment by investigators in clinical trials for hidradenitis suppurativa

Garg, Amit, Strunk, Andrew, Midgette, Bria, Frasier, Kelly, Cohn, Erica, Aarts, Pim, Alavi, Afsaneh, Alhusayen, Raed, Bechara, Bitte Falk G., Bettoli, Vincenzo, Brassard, Alain, Brown, Debra P., Chandran, Nisha Suyien, Choon, Siew Eng, Cohen, Steven R., Daveluy, Steven, del Marmol, Veronique, Dellavalle, Robert P., Emtestam, Lennart, Farida, Benhadou, Fernandez-Penas, Pablo, Flowers, R. Hal, Frew, John W., Gebauer, Kurt A., Giamarellos-Bourboulis, Evangelos J., Goldfarb, Noah, Horváth, Barbara, Hsiao, Jennifer L., Jemec, Gregor, Lowes, Michelle A., Marzano, Angelo V., Matusiak, Lukasz, Micheletti, Robert G., Oon, Hazel H., Orenstein, Lauren A. V., Ortega-Loayza, Alex G., Paek, So Yeon, Pascual, Jose C., Piguet, Vincent, Resnik, Barry I., Rosmarin, David, Roth, Gretchen M., Sayed, Christopher J., Silva, Dimitri Luz Felipe, Thorlacius, Linnea, Tzellos, Thrasyvoulos, van der Zee, Hessel, van Straalen, Kelsey and Ingram, John R. ORCID: https://orcid.org/0000-0002-5257-1142 2025. Standardization of lesion classification and assessment by investigators in clinical trials for hidradenitis suppurativa. JAMA Dermatology 10.1001/jamadermatol.2025.4652

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Abstract

Importance: Accuracy in lesion classification and reliability of lesion assessments by investigators in clinical trials for hidradenitis suppurativa (HS) may be limited. Objective: To establish consensus-based morphological definitions of HS lesions and guidance statements that standardize lesion assessments for implementation in clinical trials for HS. Evidence Review: 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 two electronic Delphi (e-Delphi) surveys. A virtual group discussion after round 1 supported participants in round 2 voting. Findings: Response rates were 50 of 59 (84.7%), 43 of 50 (86.0%), and 40 of 44 (90.9%) in the preliminary, e-Delphi round 1, and e-Delphi round 2 surveys, respectively. Morphological definitions for 11 lesion types in HS achieved the pre-specified 70% consensus threshold, with 9 definitions reaching at least 90% agreement. After two e-Delphi rounds, 15 of 17 guidance statements achieved the pre-specified consensus threshold, with 13 statements receiving endorsement from over 80% of participants. Two guidance statements related to assessment of a fistulous plaque with multiple openings and assessment of scalp lesions failed to reach consensus. Conclusions and Relevance: Morphologic definitions for HS lesions and guidance that standardizes 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.

Item Type:	Article
Date Type:	Published Online
Status:	In Press
Schools:	Schools > Medicine
Additional Information:	RRS policy applied
Publisher:	American Medical Association
ISSN:	2168-6068
Date of First Compliant Deposit:	29 November 2025
Date of Acceptance:	26 November 2025
Last Modified:	01 Dec 2025 10:00
URI:	https://orca.cardiff.ac.uk/id/eprint/182751

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