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ImportanceFew simplified instruments exist for use in hidradenitis suppurativa (HS) trials.ObjectiveTo assess psychometric properties of the Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) score using a clinical trial data set.Design, Setting, and ParticipantsThis retrospective analysis of a phase 2 randomized double-blind, placebo-controlled, active-reference arm trial (UCB HS0001) included adults with moderate-to-severe HS.ExposuresTrial participants were randomized at baseline to receive bimekizumab, adalimumab, or placebo.Main Outcomes and MeasuresThe HS-IGA score at prespecified time points up to 12 weeks after randomization.ResultsThe HS-IGA score showed strong convergent validity with IHS4 and HS-PhGA scores at baseline (Spearman correlation, 0.86 [P P P P 2 = 18.45; P 2 = 18.11; P 2 = 20.83; P Conclusions and RelevanceThe HS-IGA score demonstrated good psychometric properties compared with existing measures and may be considered for use as an end point in clinical trials for HS.

ImportanceVarious surgical approaches for hidradenitis suppurativa (HS) have been described in the literature, but the nomenclature is inconsistent. Excisions have been described as wide, local, radical, and regional with variable descriptions of margins. Deroofing procedures have been described with various approaches though descriptions of the approach are generally more uniform. No international consensus has been formed to globally standardize terminology for HS surgical procedures. Lack of such agreement may contribute to misunderstanding or misclassification in HS procedural research studies and impair clear communication among clinicians or between clinicians and patients.ObjectiveTo create a set of standard definitions for HS surgical procedures.Design, Setting, and ParticipantsThis consensus agreement study was conducted from January to May 2021 using the modified Delphi consensus method to reach agreement among a group of international HS experts regarding standardized definitions for an initial set of HS surgical terms, including “incision and drainage,” “deroofing/unroofing,” “excision,” “lesional excision,” and “regional excision,” ultimately expanded to 10 terms. Provisional definitions were drafted based on existing literature and discussion among an expert 8-member steering committee. Online surveys were disseminated to members of the HS Foundation, direct contacts of the expert panel, and the HSPlace listserv to reach physicians with considerable experience with HS surgery. Consensus was defined as greater than 70% agreement to accept a definition.ResultsIn the first and second modified Delphi round, 50 and 33 experts participated, respectively. Ten surgical procedural terms and definitions reached consensus with greater than 80% agreement. Overall, the term “local” excision was abandoned and replaced with the descriptors “lesional” or “regional” excision. Of note, “regional” replaced the terms “wide” and “radical” excision. Furthermore, modifiers such as “partial” vs “complete” should also be included when describing surgical procedures. A combination of these terms helped formulate the final glossary of HS surgical procedural definitions.Conclusion and RelevanceAn international group of HS experts agreed on a set of definitions describing surgical procedures frequently used by clinicians and in the literature. The standardization and application of such definitions are vital to allow for accurate communication, reporting consistency, and uniform data collection and study design in the future.

IMPORTANCE: Hidradenitis suppurativa (HS) is a chronic autoinflammatory disease that is highly associated with affective disorders such as depression and anxiety. Recent studies have shown that patients with HS may also endorse high levels of internalized skin bias (ISB). This redirection of skin disease−related social stigma toward oneself may also play an important role in the associations between adverse psychopathology (eg, depression, anxiety) and health-related quality of life (HRQOL). OBJECTIVES: To evaluate the associations of ISB with other core outcomes in HS and to determine if ISB may mediate the associations between adverse psychopathological outcomes and impaired HRQOL. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study of adult patients with HS recruited from 1 academic medical center as well as through virtual social and recruitment networks. Eligible participants completed an online survey comprised of 4 survey instruments along with demographic and disease history information from April 1, 2021, to July 15, 2021. MAIN OUTCOMES AND MEASURES: Measures included the Internalized Skin Bias Questionnaire (ISBQ), Burns Anxiety Inventory, the Beck Depression Inventory−II, the Hidradenitis Suppurativa Quality of Life (HiSQOL) instrument, along with demographic and disease history information. The primary outcome was HRQOL as measured by the HiSQOL. Data were analyzed in July through August 2021. RESULTS: The survey was completed by 230 of 279 patients (82.4%; mean [SD] age, 39.2 [11.2] years; 209 [90.9%] identified as female, 203 [88.7%] as not Hispanic, 178 [77.7%] as White). Depression and anxiety were shown to be a substantial burden in this sample, with 56.5% of participants’ scores qualifying for moderate or greater anxiety and 45.7% moderate or greater depression. The mean (SD) HRQOL scores were moderately high at 34.5 (16.7), indicating strong levels of impairment. There was a moderate correlation between ISBQ score and depression (r = 0.67); and fair correlations with HRQOL (r = 0.52) and anxiety (r = 0.56). Therefore, ISB appears to positively mediate the associations between depression and anxiety (estimated proportions of total effect that were mediated, 38.7% and 24.9%, respectively) and HRQOL. After controlling for age, disease severity, and disease duration, both ISB and anxiety were positive predictors of impaired HRQOL. CONCLUSIONS AND RELEVANCE: This cross-sectional study found that ISB was associated with adverse psychopathology and impaired HRQOL in patients with HS. Furthermore, ISB appears to mediate the associations of depression and anxiety with HRQOL. Future studies are needed to design interventions targeted at addressing adverse psychopathology associated with ISB and improving HRQOL and well-being for patients with HS.

The identification and validation of biomarkers in hidradenitis suppurativa (HS) has potential to improve the understanding and management of this chronic, burdensome disease.To systematically identify all known HS biomarkers, categorize them by biomarker type, and critically evaluate their validity according to established criteria.Eligibility criteria for this review (PROSPERO Registration 230830) included randomized clinical trials, uncontrolled clinical trials, cohort studies, case-control studies, and other observational studies with no restrictions of patient age, sex, race or ethnicity, or language of publication up until December 31, 2020. All articles were categorized into biomarker type, defined using the US Food and Drug Administration Biomarkers, Endpoints, and other Tools (BEST) glossary. Assessment of each identified biomarker was undertaken in line with the US Food and Drug Administration and European Medicines Agency guidelines for the validation of proposed biomarkers. Assessment of the strength of overall data regarding individual biomarkers was undertaken using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach.A total of 3953 nonduplicate articles were screened, of which 1429 articles were retrieved based on the include/exclusion criteria applied. After full-text screen and data extraction, 106 articles were included in this review. The evidence of strength of 6 categories of biomarkers (susceptibility/risk, diagnostic, monitoring, predictive, prognostic, and pharmacodynamic/response biomarkers) was assessed using GRADE criteria. A total of 48 biomarkers were identified with a minimum GRADE rating of moderate. Only 1 diagnostic (serum IL-2R), 1 monitoring (dermal Doppler vascularity), and 2 predictive biomarkers (epithelialized tunnels and positive family history of HS) achieved a GRADE rating of high. None of the identified biomarkers had sufficient clinical validity to be recommended for routine use in the clinical setting.Major barriers to the identification, validation, and introduction of routine biomarkers in the management of HS include lack of independent biomarker validation studies (especially assumption-free "omics"-based techniques); insufficient assessment of collinearity between identified or proposed biomarkers; and a lack of routine integration of biomarkers into the structure of clinical trials. International consensus among researchers, clinicians, and pharmaceutical stakeholders is required to standardize goals and methods and encourage biomarker integration into future HS clinical trials. This systematic review presents a number of priorities for near-term future research to overcome such barriers and limitations of biomarkers in HS.

IMPORTANCE: Generalized pustular psoriasis (GPP) is a chronic, orphan disease with limited epidemiological data. OBJECTIVE: To describe the clinical characteristics, treatments, longitudinal disease course, and disease-specific health care utilization among patients with GPP across the United States. DESIGN, SETTING, AND PARTICIPANTS: A retrospective longitudinal case series involving 95 adults who met the European Rare and Severe Psoriasis Expert Network consensus definition for GPP and were treated at 20 US academic dermatology practices between January 1, 2007, and December 31, 2018. MAIN OUTCOMES AND MEASURES: The primary outcome is to describe the patient characteristics, associated medical comorbidities, treatment patterns complications, and GPP–specific health care utilization. RESULTS: Sixty-seven of 95 patients (70.5%) were women (mean age, 50.3 years [SD, 16.1 years]). In the initial encounter, 35 patients (36.8%) were hospitalized and 64 (67.4%) were treated with systemic therapies. In total, more than 20 different systemic therapies were tried. During the follow-up period, 19 patients (35.8%) reported hospitalizations at a median rate of 0.5 hospitalizations per year (IQR, 0.4-1.6). Women had a decreased risk of an emergency department or hospital encounter (odds ratio, 0.19; 95% CI, 0.04-0.83). CONCLUSIONS AND RELEVANCE: Generalized pustular psoriasis is a rare, chronic disease without standard treatment and is associated with continued health care utilization over time.

Importance Standard morphological terminology and definitions are vital for identification of lesion types in the clinical trial setting and communication about the condition. For hidradenitis suppurativa (HS), morphological definitions have been proposed by different groups, representing various regions of the world, but no international consensus has been reached regarding such definitions. A lack of globally harmonized terminology and definitions may contribute to poor-quality data collection in clinical trials as well as poor communication among clinicians, investigators, and patients. Objective To establish and validate consensus definitions for typical morphological findings for HS lesions. Methods This study was conducted from August 2019 to August 2020. A Delphi study technique was used to assess agreement and then resolve disagreement on HS terminology among international experts. After an initial preparation phase, the process consisted of 3 rounds. In each round, participants reviewed preliminary definitions and rated them as “keep, with no changes,” “keep, with changes,” or “remove.” Eight HS primary lesions, including papule, pustule, nodule, plaque, ulcer, abscess, comedo, and tunnel, were selected because they are most frequently used in HS clinician-reported outcome measures. The initial definitions were based on extant literature, and modifications were made between rounds based on qualitative thematic analysis of open-ended responses or discussion. Consensus was defined as greater than 70% to accept a definition. Consensus stability across rounds was defined as less than 15% change in agreement. Reliability was evaluated using the Gwet agreement coefficient. Validation was based on assessment of face validity and stability across rounds. Results A total of 31 experts participated. All 8 HS primary lesion definitions achieved greater than 70% consensus by Delphi round 3. Stability was achieved for papule, pustule, and abscess. The Gwet agreement coefficient increased from 0.49 (95% CI, 0.26-0.71) in round 1 to 0.78 (95% CI, 0.64-0.92) in round 3. Face validity was supported by expert endorsement to keep terms in survey responses. Previously unmeasured variation among clinicians’ definition of tunnels was identified, and consensus was achieved. Conclusions and Relevance An international group of experts agreed on definitions for morphological features of HS lesions frequently included in HS clinical trials. These international consensus terms and definitions are needed to support consistency of lesion identification and quantification in clinical trials.

Importance Nurse practitioners (NPs) and physician assistants (PAs) are nonphysician clinicians (NPCs) who can deliver dermatology services. Many of these services are provided independently. Little is known about the types of services provided or where NPCs provide independent care. Objective To examine characteristics of dermatology care for Medicare enrollees billed independently by NPCs. Design, Setting, and Participants Retrospective review of the 2014 Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File, which reflects fee-for-service payments to clinicians for services rendered to Medicare beneficiaries. Clinician location was matched with county-level demographic data from the American Community Survey, US Census Bureau. Clinicians identified using National Provider Identifier as NPs or PAs with at least 11 claims for common dermatology-associated Healthcare Common Procedure Coding System procedure codes were included. Main Outcomes and Measures Total services provided by service type category, density of dermatologists and nondermatologists who perform dermatology-related services, and geographic location by county. Results Among the cohort of NPCs were 824 NPs (770 [93.5%] female) and 2083 PAs (1602 [76.9%] female) who independently billed Medicare $59 438 802 and $171 645 943, respectively. Dermatologists were affiliated with 2667 (92%) independently billing NPCs. Most payments were for non–evaluation and management services including destruction of premalignant lesions, biopsies, excisions of skin cancer, surgical repairs, flaps/grafts, and interpretation of pathologic analysis. Nurse practitioners and PAs billed for a similar distribution of service categories overall. A total of 2062 (70.9%) NPCs practiced in counties with dermatologist density of greater than 4 per 100 000 population. Only 3.0% (86) of independently billing NPCs practiced in counties without a dermatologist. Both dermatologists and NPCs were less likely to be in rural counties than in urban counties. Conclusions and Relevance Nonphysician clinicians independently billed for a wide variety of complex dermatologic procedures. Most independently billing NPCs practice in counties with higher dermatologist densities, and nearly all these NPCs were affiliated with dermatologists. Further study of NPC training and integration with the dermatology discipline is an important part of addressing the changing US dermatology workforce.

Importance Actinic keratosis (AK) is a skin growth induced by UV light exposure that requires long-term management because a small proportion of the disease can progress to squamous cell carcinoma. The influence of how clinicians frame or present information to patients may affect decision making about AK. Objective To evaluate the differences in patients’ decisions on whether to receive treatment for AK related to information presentation or choice framing. Design, Setting, and Participants A prospective survey study was performed from June 1 to July 31, 2016, in participants who were able to read English. Participants were recruited through the Penn State Milton S. Hershey Dermatology Clinic and an online survey site. The survey was conducted through an online portal. A total of 571 individuals were recruited. Regression analysis, correlation coefficient analysis, and test-retest validation were conducted. Main Outcomes and Measures The proportions of patients choosing to receive treatment for AK. Analyses were performed to adjust for age, sex, educational level, history of skin cancer, and history of AK. Results Of the 571 recruited participants, 539 (94.4%) returned completed surveys. The mean (SD) age of respondents was 42.9 (17.8) years; 306 (56.8%) were women. The decision to receive treatment for AK varied from 57.7% (n = 311) to 92.2% (n = 497) for the 5 scenarios presented in the questions ( P P ≤ .001). Based on a regression analysis, age, sex, and previous diagnosis of skin cancer were not significantly associated with the participants’ responses. Conclusions and Relevance This study found that patients’ decisions on whether to receive treatment for AK is significantly affected by physician wording, especially with alterations in the presentation of risk of malignant transformation.