Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Nov 26.
doi: 10.1001/jamadermatol.2025.4652. Online ahead of print.

Standardization of Lesion Classification and Assessment by Investigators in Clinical Trials for Hidradenitis Suppurativa: A Consensus Exercise Using a Modified Delphi Approach

Amit Garg  1 , Andrew Strunk  1 , Bria Midgette  1 , Kelly Frasier  1 , Erica Cohn  1 , Pim Aarts  2 , Afsaneh Alavi  3 , Raed Alhusayen  4 , Bitte Falk G Bechara  5 , Vincenzo Bettoli  6 , Alain Brassard  7 , Debra P Brown  8 , Nisha Suyien Chandran  9 , Siew Eng Choon  10 , Steven R Cohen  11 , Steven Daveluy  12 , Veronique Del Marmol  13 , Robert P Dellavalle  14 , Lennart Emtestam  15 , Benhadou Farida  16 , Pablo Fernandez-Penas  17 , R Hal Flowers  18 , John W Frew  19 , Kurt A Gebauer  20 , Evangelos J Giamarellos-Bourboulis  21 , Noah Goldfarb  14 , Barbara Horváth  22 , Jennifer L Hsiao  23 , Gregor Jemec  24 , Michelle A Lowes  25 , Angelo V Marzano  26   27 , Lukasz Matusiak  28 , Robert G Micheletti  29   30   31 , Hazel H Oon  32 , Lauren A V Orenstein  33 , Alex G Ortega-Loayza  34 , So Yeon Paek  35 , Jose C Pascual  36 , Vincent Piguet  37 , Barry I Resnik  38 , David Rosmarin  39 , Gretchen M Roth  40 , Christopher J Sayed  41 , Dimitri Luz Felipe Silva  42   43 , Linnea Thorlacius  44 , Thrasyvoulos Tzellos  45 , Hessel van der Zee  2 , Kelsey van Straalen  2 , John R Ingram  46
Affiliations

Standardization of Lesion Classification and Assessment by Investigators in Clinical Trials for Hidradenitis Suppurativa: A Consensus Exercise Using a Modified Delphi Approach

Amit Garg et al. JAMA Dermatol. .

Abstract

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.

PubMed Disclaimer