TY - JOUR
T1 - Standardization of Lesion Classification and Assessment by Investigators in Clinical Trials for Hidradenitis Suppurativa
T2 - A Consensus Exercise Using a Modified Delphi Approach
AU - Garg, Amit
AU - Strunk, Andrew
AU - Midgette, Bria
AU - Frasier, Kelly
AU - Cohn, Erica
AU - Aarts, Pim
AU - Alavi, Afsaneh
AU - Alhusayen, Raed
AU - Bechara, Bitte Falk G.
AU - Bettoli, Vincenzo
AU - Brassard, Alain
AU - Brown, Debra P.
AU - Chandran, Nisha Suyien
AU - Choon, Siew Eng
AU - Cohen, Steven R.
AU - Daveluy, Steven
AU - Del Marmol, Veronique
AU - Dellavalle, Robert P.
AU - Emtestam, Lennart
AU - Farida, Benhadou
AU - Fernandez-Penas, Pablo
AU - Flowers, R. Hal
AU - Frew, John W.
AU - Gebauer, Kurt A.
AU - Giamarellos-Bourboulis, Evangelos J.
AU - Goldfarb, Noah
AU - Horváth, Barbara
AU - Hsiao, Jennifer L.
AU - Jemec, Gregor
AU - Lowes, Michelle A.
AU - Marzano, Angelo V.
AU - Matusiak, Lukasz
AU - Micheletti, Robert G.
AU - Oon, Hazel H.
AU - Orenstein, Lauren A.V.
AU - Ortega-Loayza, Alex G.
AU - Paek, So Yeon
AU - Pascual, Jose C.
AU - Piguet, Vincent
AU - Resnik, Barry I.
AU - Rosmarin, David
AU - Roth, Gretchen M.
AU - Sayed, Christopher J.
AU - Silva, Dimitri Luz Felipe
AU - Thorlacius, Linnea
AU - Tzellos, Thrasyvoulos
AU - Van der Zee, Hessel
AU - Van Straalen, Kelsey
AU - Ingram, John R.
N1 - Publisher Copyright:
© 2025 American Medical Association. All rights reserved, including those for text and data mining, AI training, and similar technologies.
PY - 2026/1/21
Y1 - 2026/1/21
N2 - IMPORTANCE: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. OBJECTIVE:To establish consensus-based morphological definitions of HS lesions and guidance statements that standardize investigator lesion assessments for implementation in clinical trials. 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 2 electronic Delphi surveys. A virtual group discussion after round 1 supported participants in round 2 voting. FINDINGS: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. CONCLUSIONS AND RELEVANCE: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.
AB - IMPORTANCE: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. OBJECTIVE:To establish consensus-based morphological definitions of HS lesions and guidance statements that standardize investigator lesion assessments for implementation in clinical trials. 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 2 electronic Delphi surveys. A virtual group discussion after round 1 supported participants in round 2 voting. FINDINGS: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. CONCLUSIONS AND RELEVANCE: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.
UR - https://www.scopus.com/pages/publications/105023656264
U2 - 10.1001/jamadermatol.2025.4652
DO - 10.1001/jamadermatol.2025.4652
M3 - Review article
C2 - 41296358
AN - SCOPUS:105023656264
SN - 2168-6068
VL - 162
SP - 72
EP - 79
JO - JAMA Dermatology
JF - JAMA Dermatology
IS - 1
ER -