Roth, Gretchen M.

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.

Abstract Background African Americans face a disproportionate incidence and prevalence of hidradenitis suppurativa (HS) in the United States, but HS severity and outcomes across racial and ethnic groups have not been well‐established while controlling for potentially confounding factors. In this retrospective cohort study, we investigated the associations of race and ethnicity with HS severity, emergency department (ED) visits, hospitalizations, and surgeries for HS while controlling for age, sex, body mass index (BMI), tobacco use, and insurance type. Methods We reviewed 1190 patients seen at the Medical College of Wisconsin with ≥3 encounters for HS between 1/1/2002 and 3/19/2019, excluding those without race data or an encounter in which HS was treated. Results A total of 953 patients were included; 470 patients were Black or African American non‐Hispanic (49%), 39 Hispanic (4%), 418 White non‐Hispanic (44%), and 26 other race or ethnicity (3%). Controlling for age, sex, BMI, tobacco use, and insurance type, Black patients had 2.8 times the odds of having Hurley stage III disease (95% CI 1.76–4.45, P < 0.001), 2.86 times the risk for experiencing an ED visit for HS (95% CI 2.12–3.88, P < 0.001), 2.25 times the risk for experiencing a hospitalization for HS (95% CI 1.42–3.56, P < 0.001), and 1.61 times the risk for experiencing a surgical encounter for HS (95% CI 1.34–1.95, P < 0.001) when compared to White patients. Conclusions African Americans face significant disparities in HS severity, ED visits, hospitalizations, and surgeries. The causes of these disparities must be further investigated and addressed.