Standardization of Lesion Classification and Assessment by Investigators in Clinical Trials for Hidradenitis Suppurativa: A Consensus Exercise Using a Modified Delphi Approach.
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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, Ingram John R
Аннотация
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.