Evaluation of Inclusion and Exclusion Criteria for Pyoderma Gangrenosum in Clinical Research: A Systematic Review.

INTRODUCTION: Pyoderma gangrenosum (PG) is a rare, inflammatory dermatologic disease that, as a diagnosis of exclusion with nonspecific histologic features, is difficult to diagnose. As pharmaceutical interest in potential treatments for PG increases, the need for standardized diagnostic criteria to ensure reproducibility, comparability, and external validity of PG research is required. In this study, we aim to characterize the inclusion and exclusion criteria used in the diagnosis of PG in clinical research studies as well as the eligibility of PG in clinical trials. METHODS: A systematic review was conducted to characterize the PG inclusion and exclusion criteria in research studies. An additional search of the USA and international clinical trials databases was conducted as well to capture eligibility criteria for PG trials. RESULTS: Our study revealed a broad range of inclusion and exclusion criteria used to establish the presence or absence of PG. Based on eight distinct categories used to characterize inclusion criteria for research studies, diagnosis by a dermatologist (n = 25, 31.6%), no inclusion criteria listed (n = 21, 26.6%), and clinical and histopathologic features consistent with PG (n = 20, 25.3%) were most common. For current clinical trials, six categories were used to characterize inclusion criteria, of which clinical and histopathologic features consistent with PG (n = 5, 31.3%), identification based on diagnosis of PG (n = 4, 25.0%), and clinical features consistent with PG (n = 3, 18.8%) were the most common. CONCLUSION: This systematic literature review highlights the range of heterogeneity in diagnostic and eligibility criteria used in PG-directed clinical research and current clinical trials and illustrates the need for the development of consensus guidelines and a rigorous framework to enable high-quality future trials for PG.

Eligibility Criteria for Active Ulcerative Pyoderma Gangrenosum in Clinical Trials: A Delphi Consensus on Behalf of the UPGRADE (Understanding Pyoderma Gangrenosum: Review and Assessment of Disease Effects) Group.

At present, there are no standardized guidelines for determining patient eligibility for pyoderma gangrenosum (PG) clinical trials. Thus, we aim to determine which clinical features, histopathological features, or laboratory features should be included in active ulcerative PG clinical trial eligibility criteria for treatment-naïve patients and patients already treated with immunomodulating medications (treatment-exposed patients). This study employed 4 rounds of the Delphi technique. Electronic surveys were administered to 21 international board-certified dermatologists and plastic surgeon PG experts (June 2022-December 2022). Our results demonstrated that for a patient to be eligible for a PG trial, they must meet the following criteria: (i) presence of ulcer(s) with erythematous/violaceous undermining wound borders, (ii) presence of a painful or tender ulcer, (iii) history/presence of rapidly progressing disease, (iv) exclusion of infection and other causes of cutaneous ulceration, (v) biopsy for H&E staining, and (vi) a presence/history of pathergy. These criteria vary in importance for treatment-naïve versus treatment-exposed patients. Given the international cohort, we were unable to facilitate live discussions between rounds. This Delphi consensus study provides a set of specific, standardized eligibility criteria for PG clinical trials, thus addressing one of the main issues hampering progress toward Food and Drug Administration approval of medications for PG.

Post-Traumatic Stress Disorder in Patients with Alopecia Areata: A Survey Study in the USA.

Introduction: Alopecia areata (AA) is an autoimmune condition that results in nonscarring hair loss. AA is comorbid with mental health disorders including anxiety and depression. This study aimed to evaluate the presence of post-traumatic stress disorder (PTSD) in relation to hair loss in patients with AA. Methods: A cross-sectional national survey was distributed using the National Alopecia Areata Foundation's (NAAF) email list. This study was approved by the Mass General Brigham Institutional Review Board. Participants were asked to complete the PTSD Checklist for the DSM-5 (PCL-5), a validated screening tool for PTSD in the context of their AA. Results: Of the 1,449 completed surveys (completion rate 79.6%), most respondents were female (83.8%) and white (76.6%) with an average age of 50.6 ± 15.6 years. Respondents had AA for an average of 17.7 ± 15.8 years, with 91.4% experiencing current active hair loss. A total of 33.9% of respondents screened positively for PTSD, with an average score of 48.8 ± 12.3 on the PCL-5 in participants who screened positively. Participants with alopecia totalis have the highest average PCL-5 score of 30.1 ± 19.2, followed by participants with alopecia universalis with an average score of 26.0 ± 19.9, and lastly patchy AA with an average score of 24.5 ± 18.3 (p = 0.003). Feelings of intrusion and avoidance were the predominant reported symptoms. Total PTSD scores were significantly higher in respondents who were younger and identified as Black or African American and Hispanic when compared to white and non-Hispanic respondents, respectively. Conclusion: These findings identify that one in 3 patients with AA in this cohort meet the screening criteria for PTSD specifically relating to their hair loss experience. These results further highlight the mental health comorbidities associated with AA and emphasize that these symptoms may persist even after hair regrowth. Limitations include the nonrandomized NAAF population with most participants being white females. Future studies should confirm these findings in other patient populations. Finally, respondent's baseline mental health was not assessed; therefore, a causal relationship between AA and PTSD cannot be deduced.

Experiencing Workplace Bullying in Patients with Alopecia Areata: A Cross-Sectional Survey Study.

Introduction: Alopecia areata (AA) is an immune-mediated hair loss condition with substantial psychosocial impact. The impact of AA on social interactions at work has not been established. Methods: We administered the Negative Acts Questionnaire-Revised Scale to the National Alopecia Areata Foundation database to evaluate workplace bullying in patients with AA. Results: Ultimately, 673/1,120 individuals who met inclusion criteria completed the survey. Most respondents were female (n = 537, 79.8%), Caucasian (n = 508, 75.5%), with an average age of 46.8 ± 14, and employed full-time (n = 427, 63.4%). Our results demonstrate 21.7% (n = 146) of respondents experienced workplace bullying. Participants most frequently faced having their opinions ignored (53.8%, n = 362), being excluded (47.7%, n = 321), and having gossip spread about them (44.0%, n = 296). Notably, 75.0% (n = 120/160) of individuals who self-reported bullying addressed the behavior; however, 30.8% of participants noted the bully continued (30.8%, n = 37). Stress associated with filing a complaint (43.5%, n = 293) and effect on future career options (36.1%, n = 243) were common barriers to report bullying. Conclusion: This study expands our understanding of the psychosocial impact of AA by confirming individuals with AA experience workplace bullying. Stigma against patients may play a role in this phenomenon. Future work is warranted to identify strategies to reduce bullying against patients with AA.

An Assessment of Current Clinician-Reported and Patient-Reported Outcome Measures for Alopecia Areata: A Scoping Review.

Although progress has been made in developing outcome measures for AA, the use of these measures remains unstandardized. A scoping review was conducted to identify the clinician-reported outcome measures (ClinROMs) and patient-reported outcome measures (PROMs) used in assessing and treating AA, the results of which revealed heterogeneity in AA outcome measures. Of 23 research studies ultimately included, only 2 ClinROMs were used by >15% of studies; likewise, of 110 clinical trials evaluated, numerous outcome instruments were used, but only one ClinROM was used by >5% of trials (Severity of Alopecia Tool). These results suggest the need for consensus and standardization in both research and trial settings.

Physician values in alopecia areata treatment decision-making: A qualitative assessment.

Background: Alopecia areata (AA) is a disease of hair loss with multiple treatment options. Physicians play an important role in guiding patients during the decision-making process. Objective: Assess physicians' values and attitudes when helping patients choose an AA treatment. Methods: Semi-structured qualitative interviews were conducted with dermatologists of varying practice type and location. Each interview was coded independently twice using inductive thematic analysis. Interrater reliability and code frequencies were determined. Results: Fourteen participants were interviewed. Interrater reliability was κ = 0.85 to 0.97. Dermatologists wanted patients to consider various treatment factors (ie, efficacy, safety, convenience of use, accessibility) and also assessed patients' AA clinical severity and personality traits. Participants often encountered various barriers to effective communication with patients, which may be mitigated by shared decision-making. Shared decision-making tools were perceived to potentially improve patient care and communication, although physicians expressed concern about lack of individualization, limitations of time, and the appropriateness of information. Conclusion: AA treatment decision-making is a complex process that often utilizes the expertise of a dermatologist, during which shared decision-making tools may be of value to both patients and physicians.

Factors influencing alopecia areata treatment decisions: A qualitative assessment.

Background: Alopecia areata (AA) is a disease of hair loss in which patients may benefit from comprehensive understanding of AA's disease process and therapeutic options during treatment decision-making. Objective: Determine factors influencing patients' AA treatment decision-making. Methods: Qualitative interviews were conducted using semi-structured interview guides. Interviews were coded using inductive thematic analysis. Results: Twenty-one participants with AA were interviewed. Coding interrater reliability was κ = 0.87-0.91, indicating strong-almost perfect agreement. Participants faced multiple barriers, including lack of access to health care (n = 10, 47.6%) and lack of transparency about their condition and treatment options (n = 9, 42.9%). Information about AA was sought from primarily the internet (n = 15, 71.4%) and physician recommendation (n = 15, 71.4%). When choosing AA treatments, patients often considered treatment efficacy (n = 21, 100%), safety (n = 21, 100%), and convenience of use (n = 20, 95.2%). Limitations: Referral and regional biases may be present and limit generalizability. Conclusions: Patients with AA face various challenges including medical uncertainty and lack of information. Patients need trustworthy and accessible sources of information regarding their treatment that also take into consideration their preferences and values.

Development and Validation of a Simple Model to Predict the Risk of Nonmelanoma Skin Cancer on Screening Total Body Skin Examination.

Objective: There is insufficient evidence to generate skin cancer screening guidelines at the population level, resulting in arbitrary variation in patient selection for screening skin examinations. This study was aimed at developing an easy-to-use predictive model of nonmelanoma skin cancer (NMSC) risk on screening total body skin examination (TBSE). Methods: This epidemiologic assessment utilized data from a prospective, multicenter international study from primarily academic outpatient dermatology clinics. Potential predictors of NMSC on screening TBSE were identified and used to generate a multivariable model that was converted into a point-based scoring system. The performance characteristics of the model were validated in a second data set from two healthcare institutions in the United States. Results: 8,501 patients were included. Statistically significant predictors of NMSC on screening TBSE included age, skin phototype, and history of NMSC. A multivariable model and point-based scoring system using these predictors exhibited high discrimination (AUC = 0.82). Conclusion: A simple three-variable model, abbreviated as CAP (cancer history, age, phototype) can accurately predict the risk of NMSC on screening TBSE by dermatology. This tool may be used in clinical decision making to enhance the yield of screening TBSE.

Prevalence of Misrepresentation of Nonphysician Clinicians at Dermatology Clinics.

INTRODUCTION: To evaluate the use of inaccurate terminology used by dermatology practices to describe the training and qualifications of their nonphysician clinicians (NPCs) when new patients are booking appointments. METHODS: Clinics were randomly selected and called to determine the first available appointment for a new patient with a new and changing mole. If the receptionist confirmed the first-offered appointment was with an NPC, the encounter was included in this study. If receptionists used inaccurate terminology to describe the NPCs and their qualifications, this instance was recorded along with the specific language that they used. RESULTS: A total of 344 unique dermatology clinics were contacted on February 27, 2020, in 25 states. Phone calls at 128 clinics (37.2%) met our inclusion criterion. Inaccurate language was used to describe NPCs at 23 (18%) unique clinic locations across 12 states, with "dermatologist," "doctor," "physician," and "board-certified" being used to describe NPCs as the most common inaccurate terms. CONCLUSION: These findings demonstrate that front office staff at dermatology clinics use inaccurate and potentially misleading terminology to refer to NPCs working in their clinics. While we cannot establish whether this is intentional or due to a lack of training, additional focus should be placed on accurately representing provider qualifications to patients.

Consensus-Based Recommendations on the Prevention of Squamous Cell Carcinoma in Solid Organ Transplant Recipients: A Delphi Consensus Statement.

IMPORTANCE: There is a paucity of evidence to guide physicians regarding prevention strategies for cutaneous squamous cell carcinoma (CSCC) in solid organ transplant recipients (SOTRs). OBJECTIVE: To examine the development and results of a Delphi process initiated to identify consensus-based medical management recommendations for prevention of CSCC in SOTRs. EVIDENCE REVIEW: Dermatologists with more than 5 years' experience treating SOTRs were invited to participate. A novel actinic damage and skin cancer index (AD-SCI), consisting of 6 ordinal stages corresponding to an increasing burden of actinic damage and CSCC, was used to guide survey design. Three sequential web-based surveys were administered from January 1, 2019, to December 31, 2020. Pursuant to Delphi principles, respondents thoroughly reviewed all peer responses between rounds. Supplemental questions were also asked to better understand panelists' rationale for their responses. FINDINGS: The Delphi panel comprised 48 dermatologists. Respondents represented 13 countries, with 27 (56%) from the US. Twenty-nine respondents (60%) were Mohs surgeons. Consensus was reached with 80% or higher concordance among respondents when presented with a statement, question, or management strategy pertaining to prevention of CSCC in SOTRs. A near-consensus category of 70% to less than 80% concordance was also defined. The AD-SCI stage-based recommendations were established if consensus or near-consensus was achieved. The panel was able to make recommendations for 5 of 6 AD-SCI stages. Key recommendations include the following: cryotherapy for scattered actinic keratosis (AK); field therapy for AK when grouped in 1 anatomical area, unless AKs are thick in which case field therapy and cryotherapy were recommended; combination lesion directed and field therapy with fluorouracil for field cancerized skin; and initiation of acitretin therapy and discussion of immunosuppression reduction or modification for patients who develop multiple skin cancers at a high rate (10 CSCCs per year) or develop high-risk CSCC (defined by a tumor with approximately ≥20% risk of nodal metastasis). No consensus recommendation was achieved for SOTRs with a first low risk CSCC. CONCLUSIONS AND RELEVANCE: Physicians may consider implementation of panel recommendations for prevention of CSCC in SOTRs while awaiting high-level-of-evidence data. Additional clinical trials are needed in areas where consensus was not reached.

3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators.

BACKGROUND: In response to supply shortages caused by the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs or "masks"), which are typically single-use devices in healthcare settings, are routinely being used for prolonged periods and in some cases decontaminated under "reuse" and "extended use" policies. However, the reusability of N95 masks is limited by degradation of fit. Possible substitutes, such as KN95 masks meeting Chinese standards, frequently fail fit testing even when new. The purpose of this study was to develop an inexpensive frame for damaged and poorly fitting masks using readily available materials and 3D printing. RESULTS: An iterative design process yielded a mask frame consisting of two 3D printed side pieces, malleable wire links that users press against their face, and cut lengths of elastic material that go around the head to hold the frame and mask in place. Volunteers (n = 45; average BMI = 25.4), underwent qualitative fit testing with and without mask frames wearing one or more of four different brands of FFRs conforming to US N95 or Chinese KN95 standards. Masks passed qualitative fit testing in the absence of a frame at rates varying from 48 to 94 % (depending on mask model). For individuals who underwent testing using respirators with broken or defective straps, 80-100 % (average 85 %) passed fit testing with mask frames. Among individuals who failed fit testing with a KN95, ~ 50 % passed testing by using a frame. CONCLUSIONS: Our study suggests that mask frames can prolong the lifespan of N95 and KN95 masks by serving as a substitute for broken or defective bands without adversely affecting fit. Use of frames made it possible for ~ 73 % of the test population to achieve a good fit based on qualitative and quantitative testing criteria, approaching the 85-90 % success rate observed for intact N95 masks. Frames therefore represent a simple and inexpensive way of expanding access to PPE and extending their useful life. For clinicians and institutions interested in mask frames, designs and specifications are provided without restriction for use or modification. To ensure adequate performance in clinical settings, fit testing with user-specific masks and PanFab frames is required.

Evaluation of Stigma Toward Individuals With Alopecia.

Importance: Perceived stigma among patients with alopecia is associated with impaired quality of life; however, the magnitude of laypersons' stigma toward individuals with alopecia is unknown. Objective: To determine the prevalence and magnitude of laypersons' stigma toward individuals with varying degrees of alopecia and whether stigma increases with increased severity of alopecia. Design, Setting, and Participants: This was a cross-sectional study using an internet survey administered to a convenience sample of adult respondents in the US participating on the Amazon Mechanical Turk platform. Portrait images of 6 individuals without hair loss were created using artificial intelligence and stock images. Each portrait was edited to create 2 additional versions, 1 with scalp hair loss and 1 with complete hair loss, for a total of 18 images. On January 9 to 10, 2020, the survey presented each internet respondent with 1 randomly selected portrait to be used in answering a series of stigma-related questions from 3 domains: stereotypes, social distance, and disease-related myths; the third domain was presented only to respondents who believed that the individual pictured had a medical condition. Main Outcomes and Measures: The main outcome was the prevalence and magnitude of stigma of laypersons toward individuals with alopecia and the percentage of laypersons who believed the individual pictured had a medical condition as recorded in survey responses. Results: The survey was completed by 2015 respondents (99.9% completion rate) with a mean age of 37 (range, 18-78) years; 1014 (50.3%) were men; 1596 (79.2%) were White; and 1397 (69.3%) had a college or postcollege education. Endorsement of every stigma item increased as alopecia severity increased (2.4%-27.6%). Absolute change on the stereotype (0.5-0.6) and social distance scales (0.2-0.5) also increased, indicating more stigma. The percentage of respondents believing the individual pictured had a medical condition increased as alopecia severity increased (33.6%-75.7%; P < .001). Among the subgroup of respondents who were asked to rate their agreement with disease-related myths, the absolute change on the myth scale decreased as alopecia severity increased, indicating decreased stigma (-0.7 to -1.2). Conclusions and Relevance: This cross-sectional survey study found that stigmatizing attitudes of laypersons toward patients with alopecia exist across a multitude of social and professional scenarios. Stigma prevalence and magnitude vary by alopecia severity and possibly by whether alopecia is believed to be a medical condition.

Insurance Acceptance, Appointment Wait Time, and Dermatologist Access Across Practice Types in the US.

Importance: In the 15 years since dermatology access was last investigated on a national scale, the practice landscape has changed with the rise of private equity (PE) investment and increased use of nonphysician clinicians (NPCs). Objective: To determine appointment success and wait times for patients with various insurance types at clinics with and without PE ownership. Design, Setting, and Participants: In this study, PE-owned US clinics were randomly selected and matched with 2 geographically proximate clinics without PE ownership. Researchers called each clinic 3 times over a 5-day period to assess appointment/clinician availability for a fictitious patient with a new and changing mole. The 3 calls differed by insurance type specified, which were Blue Cross Blue Shield (BCBS) preferred provider organization, Medicare, or Medicaid. Main Outcomes and Measures: Appointment success and wait times among insurance types and between PE-owned clinics and control clinics. Secondary outcomes were the provision of accurate referrals to other clinics when appointments were denied and clinician and next-day appointment availability. Results: A total of 1833 calls were made to 204 PE-owned and 407 control clinics without PE ownership across 28 states. Overall appointment success rates for BCBS, Medicare, and Medicaid were 96%, 94%, and 17%, respectively. Acceptance of BCBS (98.5%; 95% CI, 96%-99%; P = .03) and Medicare (97.5%; 95% CI, 94%-99%; P = .02) were slightly higher at PE-owned clinics (compared with 94.6% [95% CI, 92%-96%] and 92.8% [95% CI, 90%-95%], respectively, at control clinics). Wait times (median days, interquartile range [IQR]) were similar for patients with BCBS (7 days; IQR, 2-22 days) and Medicare (7 days; IQR, 2-25 days; P > .99), whereas Medicaid patients waited significantly longer (13 days; IQR, 4-33 days; P = .002). Clinic ownership did not significantly affect wait times. Private equity-owned clinics were more likely than controls to offer a new patient appointment with an NPC (80% vs 63%; P = .001) and to not have an opening with a dermatologist (16% vs 6%; P < .001). Next-day appointment availability was greater at PE-owned clinics than controls (30% vs 21%; P = .001). Conclusions and Relevance: Patients with Medicaid had significantly lower success in obtaining appointments and significantly longer wait times regardless of clinic ownership. Although the use of dermatologists and NPCs was similar regardless of clinic ownership, PE-owned clinics were more likely than controls to offer new patient appointments with NPCs.