How dermatologic surgeons decide to proceed with surgery for nonmelanoma skin cancer when site identification is initially uncertain: A nationwide, multicenter, prospective study.

BACKGROUND: Few studies show how dermatologic surgeons manage problems with site identification. OBJECTIVE: To estimate frequency and characterize management of skin cancer treated by surgery when the anatomic location of the tumor is in question. METHODS: Nationwide, prospective, multisite cohort study. RESULTS: Among 17,076 cases at 22 centers, 98 (0.60%) were lesions in question for which site identification was initially uncertain, with these more often in patients who were male, older, and biopsied more than 30 days ago. Surgeons employed on average 5.0 (95% CI: 4.61-5.39) additional techniques to confirm the site location, with common approaches including: re-checking available documentation (90 lesions, 92%); performing an expanded physical examination (89 lesions, 91%); and asking the patient to point using a mirror (61 lesions, 62%). In 15%, photographs were requested from the biopsying provider, and also in 15%, frozen section biopsies were obtained. In 10%, the referring physician was contacted. Eventually, surgeons succeeded in definitively identifying 82% (80 of 98) of initially uncertain sites, with the remaining 18% (18 of 98) postponed. Most postponed surgeries were at non-facial sites. LIMITATIONS: Sites were academic centers. CONCLUSIONS: When the anatomic location of the tumor is uncertain, dermatologic surgeons use multiple methods to identify the site, and sometimes cases are postponed.

From Skin to Solution: Exploring Epicutaneous Immunotherapy for Peanut Allergy-A Systematic Review and Meta-Analysis.

Peanut allergy is a leading cause of severe food reactions. This meta-analysis evaluates the efficacy and safety of epicutaneous immunotherapy (EPIT) compared to placebo for peanut-allergic individuals. After prospectively registering on PROSPERO, we searched three databases (PubMed, Google Scholar, and Cochrane CENTRAL) and 2 trial registries till September 2023. Analysis was conducted via RevMan where data was computed using risk ratios (RR). The Cochrane Risk of Bias tool and GRADE criteria were used to appraise and evaluate the evidence. From 4927 records, six multicenter randomized placebo-controlled trials comprising 1453 participants were included. The 250 µg EPIT group had a significant increase in successful desensitization compared to placebo (RR: 2.13 (95% C.I: 1.72, 2.64), P < 0.01, I2 = 0%), while the 100 µg EPIT group did not (RR: 1.54 (95% C.I: 0.92, 2.58), P = 0.10, I2 = 0%) (moderate certainty evidence). Moreover, there was a significant increase in local (RR: 1.69 (95% C.I: 1.06, 2.68), P = 0.03, I2 = 89%) and systemic adverse events (RR: 1.75 (95% C.I: 1.14, 2.69), P = 0.01, I2 = 0%) with EPIT. Additionally, individuals administered EPIT have an increased probability of requiring rescue medications like epinephrine (RR: 1.91 (95% C.I: 1.12, 3.28), P = 0.02, I2 = 0%) and topical corticosteroids (RR: 1.49 (95% C.I: 1.29, 1.73), P < 0.01, I2 = 0%) to treat adverse events. The association of adverse events post-treatment including anaphylaxis (RR: 2.31 (95% C.I: 1.00, 5.33), P = 0.05, I2 = 36%), skin/subcutaneous disorders like erythema or vesicles (RR: 0.93 (95% C.I: 0.79, 1.08), P = 0.33, I2 = 0%), and respiratory disorders like dyspnea or wheezing (RR: 0.94 (95% C.I: 0.77, 1.15), P = 0.55, I2 = 0%) with EPIT is inconclusive. EPIT, although effective in desensitization, is linked to an increased risk of adverse events. PROSPERO registration: CRD42023466600.

Split face randomized, evaluator blinded study on the effect of multiple subcisions on rolling acne scars.

Acne scarring results from a common inflammatory condition present in many people. These scars can have an impact on quality of life by influencing self-esteem and social acceptance. Current acne scarring treatments, such as chemical peels and laser treatments, often have limited success due to their time-consuming nature and the variability of acne scar types. The subcision technique has shown promise for the treatment of rolling acne scars. There are few studies to date that examine the effects of multiple subcision treatments on rolling acne scars. We evaluated whether the use of multiple subcision treatments improved the appearance of rolling acne scars compared to no treatment. Five patients with rolling acne scars on both sides of their face who met inclusion and exclusion criteria were enrolled in the study. One side of the face was randomized to receive treatment, while the contralateral side of the face received no treatment. Subjects underwent five sequential subcision treatments, spaced 4 weeks apart, with two follow-up visits at weeks 20 and 36 from the 1st treatment. Photographs were taken before and after the initial treatment visit and at each subsequent visit. Acne scar appearance was evaluated by the subject, a blinded live rater, and two double-blinded dermatologist raters. Evaluations of treatment outcomes involved overall acne scar appearance on a 5-point scale, acne scar improvement on a percentage scale, a modified quantitative global scarring grading system, and potential treatment side effects. There was a greater decrease in global scarring scores in the multiple subcision side compared to the control side. There was a greater difference in the average acne scar appearance scores between the Week 36 follow-up visit and baseline for the multiple subcision side compared to that of the control side. 50% of patients reported being more satisfied with the treatment side compared to the control side in regard to overall improvement. The study results suggest that multiple subcision treatments may improve the appearance of rolling acne scars compared to no treatment.

US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement.

Importance: The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients. Objective: To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement. Design, Setting, and Participants: This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources of information, pivotal trial design, quality of evidence, panel composition and internal deliberative process, time allocation, and impartiality of the FDA. The survey was mailed to the members of all 18 FDA device panels in January and February 2017. Data were collected from January to May 2017 and analyzed from 2018 to 2019. Exposures: Respondents read and returned the aforementioned paper survey, while nonrespondents did not. Main Outcomes and Measures: The main outcomes included panel members' perceptions, and their implications for process improvement. χ2 or Fisher exact tests were used to test differences between subgroups. Results: Of 64 of 92 panel members who responded (69.6%), 38 of 64 (59.4%) were male, 3 of 63 (4.8%) were Black respondents, 46 of 63 (73.0%) were White respondents, and 36 of 60 (60.0%) were in academic practice. The mean (range) panel service was 6.8 (1-22) years with 3.9 (1-19) meetings attended. Overall, respondents considered information presented by the FDA unbiased, and 28 of 61 (45.9%) believed that pivotal trials were frequently well-designed, 55 of 62 respondents (88.7%) suggested FDA consult panel members preemptively regarding trial design and 54 of 64 (84.4%) regarding the device label. Most indicated that prior FDA approval of another device serving the same medical purpose (43 of 62 [69.4%]) or approval in other countries with comparable regulatory regimes, such as Canada and Europe (39 of 62 [62.9%]), would make them more likely to recommend approval. Respondents rated written information (50 of 60 [83.3%]), live presentations (43 of 58 [74.1%]), and prior professional knowledge (41 of 60 [68.3%]) as the most important sources of information in deciding whether to recommend approval. Additionally, 52 of 58 respondents (89.7%) recommended that a panel member-only executive session would allow more clarity and honesty in deliberations, and 33 of 59 (55.9%) believed a three-fourths majority appropriate for recommending approval, which would be a deviation from the current system in which an overall vote is reported without designation of a vote threshold. Conclusions and Relevance: In this survey study of FDA device panel members, respondents wanted improved study designs, more relevant clinical data, including from other countries, involvement of panelists in study design and device label development, and inclusion of an executive session. Demographically, panels could be made more diverse.

Protocol of a scoping review of outcome domains in dermatology.

INTRODUCTION: Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases. METHODS AND ANALYSIS: We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts. ETHICS AND DISSEMINATION: This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

Subcision with and without suction for acne scars: a split-faced, rater-blinded randomized control trial.

Therapeutic options for acne scars include subcision and suction with microdermabrasion, but these treatment modalities have not been studied in conjunction. To compare effectiveness of subcision alone versus subcision with suction for the treatment of facial acne scars. Randomized, split-faced, evaluator-blinded control trial. Participants underwent one subcision treatment on both sides of the face followed by 10 sessions of suction to one side. Photographs at baseline, 1-month, and 4-months were assessed. Primary outcome measures were the validated Acne Scar Severity Scale (ASSS) (0 = no acne scarring, 4 = severe), Acne Scar Improvement Grading Scale (ASIGS) (-100 to 100%), and modified Quantitative Global Scarring Grades (QGSG) (point-based questionnaire instrument), as well as subject preference. Twenty-eight treatment areas and 154 treatments were analyzed. Dermatologist raters found no differences between subcision alone and subcision-suction at 1-month or 4-months. Mean subject-assessed percent improvement for subcision-suction was higher than that for subcision alone at 1-month (37% versus 24%, p = 0.04) but not at 4-months (p = 0.37). Subjects preferred combination therapy to monotherapy at 1-month (50% vs. 21%) and 4-months (43% vs. 21%). While blinded raters did not detect significant differences, subjects perceived combination treatment as working more quickly than monotherapy, and preferred combination treatment at all time points.Clinical trial registration NCT01696513 on Clinicaltrials.gov.

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement.

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Exploring the Complex Connection Between Diabetes and Cardiovascular Disease: Analyzing Approaches to Mitigate Cardiovascular Risk in Patients With Diabetes.

Cardiovascular disease (CVD) is the primary cause of morbidity and mortality in individuals diagnosed with diabetes mellitus. This narrative review offers a comprehensive examination of the complex correlation between diabetes and cardiovascular complications. The objective of this review is to analyze the most recent evidence on preventive measures and treatment options for mitigating cardiovascular risk in patients with diabetes, by synthesizing existing literature. Insulin resistance plays a crucial role in connecting diabetes and CVD, leading to the development of dyslipidemia and atherogenesis. As a result, the risk of cardiovascular events in individuals with diabetes is significantly elevated. Moreover, the presence of hyperglycemia-induced oxidative stress and inflammation serves to intensify endothelial dysfunction and vascular damage, thereby exacerbating the risk of cardiovascular complications. The interaction between diabetes and CVD frequently speeds up the development of atherosclerotic plaque, making the plaque more prone to rupture. This can lead to severe cardiovascular events such as myocardial infarction and stroke. It is crucial to comprehend the intricate relationship between diabetes and CVD in order to formulate effective strategies aimed at enhancing patient outcomes and mitigating the burden associated with these interconnected chronic conditions. Healthcare practitioners can enhance the quality of life and reduce mortality rates associated with CVD in diabetic patients by thoroughly examining evidence-based preventive measures and treatment options. This approach allows them to make informed decisions when managing cardiovascular risk. In summary, this narrative review provides a valuable resource for healthcare professionals and researchers, presenting a comprehensive analysis of the complex relationship between diabetes and CVD. By providing a comprehensive analysis of the latest evidence and elucidating the underlying mechanisms, this review seeks to establish a foundation for the development of innovative strategies in diabetes management. These strategies have the potential to significantly improve cardiovascular outcomes and enhance overall patient care.

Risk factors for hospital-based surgical site infections.

Surgical site infections (SSIs) contribute to morbidity and are costly to the healthcare system. To identify factors associated with SSIs. Case-control study analyzing the Nationwide Readmission Database (NRD). We identified 45,445 SSIs. Infection rates were higher in those who were obese (BMI ≥ 30) (OR: 1.39, 95% CI 1.28-1.51), tobacco users (OR: 1.08, 95% CI 1.02-1.15), diagnosed with diabetes (OR: 1.16, 95% CI 1.10-1.22), with Elixhauser Comorbidity Index ≥ 2 (OR: 1.14, 95% CI 1.09-1.20), admitted to hospital for 4-6 days (OR: 1.35, 95% CI 1.29-1.42), in medium-size hospital (OR: 1.15, 95% CI 1.05-1.26), or large-size hospital (OR: 1.43, 95% CI 1.31-1.56). In contrast, patients who were 60-79 years old (OR: 0.78, 95% CI 0.73-0.84), 80 years or older (OR: 0.66, 95% CI 0.59-0.73), female (OR: 0.95, 95% CI 0.91-0.99), underweight (BMI < 18.5) (OR: 0.14, 95% CI 0.03-0.59), in a non-metropolitan hospital (OR: 0.83, 95% CI 0.75-0.91), self-pay (OR: 0.82, 95% CI 0.74-0.91), or covered by Medicare (OR: 0.86, 95% CI 0.80-0.91) had lower odds. Initial data entry to NRD is susceptible to human error. Patients who are obese, use tobacco, have multiple comorbidities, and have long hospital stays in medium-to-large-size hospitals are at risk of SSIs. Conversely, odds of SSIs are lower in females, age ≥ 60, BMI < 18.5, self-pay or Medicare (versus private insurance), or at smaller hospitals. Understanding factors associated with SSIs may help surgeons anticipate complications.

Intracerebral hemorrhage outcomes in patients using direct oral anticoagulants versus vitamin K antagonists: a meta-analysis.

BACKGROUND: The objective of this paper is to assess the clinical outcomes between non-traumatic intracerebral hemorrhage(ICH) in patients using direct oral anticoagulants(DOAC) versus vitamin K antagonists(VKA) for non-valvular atrial fibrillation. We also evaluated the predictors of the poor post-ICH outcomes. METHODS: We have performed pooled meta-analysis to assess long-term clinical outcomes in patients with DOAC-ICH as compared to those with VKA-ICH. A systematic literature search was conducted by searching the full-text English literature in PubMed, EMBASE, and Cochrane databases for observational studies reporting outcomes on interest. MOOSE guidelines were used to collect data till December 31, 2019 and random effects analysis was carried out to account for heterogeneity. For outcomes, risk ratios(RR) and the mean differences were pooled using a random-effects model and weighted mean differences (WMDs), respectively. RESULTS: Seventeen studies met the inclusion criteria (n = 25,354 patients; DOAC-ICH arms = 5,631; VKA-ICH arm = 19,273). Patients with DOAC-ICH had smaller hematoma volumes (WMD=-9.59; 95%CI=-15.33--3.85; I2 = 68.6%) and reduced mortality rate at discharge (RR = 0.82; 95%CI = 0.71-0.96; I2 = 9.4%). There was no significant difference between the two groups in rate of hematoma expansion (RR = 0.79; 95%CI = 0.56-1.11; I2 = 50.9%), unfavorable functional outcome(Modified Rankin Scale) at discharge (RR = 0.82; 95%CI = 0.56-1.18; I2 = 80.2%), unfavorable outcome at 3-months (RR = 0.77; 95%CI = 0.56-1.06; I2 = 63.9), and mortality at 3-months (RR = 0.90; 95%CI = 0.73-1.10; I2 = 35∙8%). Multivariate meta-regression revealed that the average age of patient population had a significantly negative correlation with(RR=-0.202; p = 0.017) hematoma expansion. CONCLUSION: We conclude that use of DOAC is associated with reduced hematoma volume and mortality rate at discharge. Age is a predictor of the poor outcome of hematoma expansion.

Chest computed tomography findings in hospitalized COVID-19 patients: a systematic review and meta-analysis.

Most studies evaluating chest computed tomography (CT) features in coronavirus disease 2019 (COVID-19) have been small-sized and have presented varied findings. We aim to systematically review these studies and to conduct a meta-analysis of their results to provide a well-powered assessment of chest CT findings in patients with COVID-19. PubMed and EMBASE databases were systematically searched to identify published studies that evaluated chest CT findings in COVID-19 patients. Data regarding study characteristics and CT findings, including distribution of lesions, the lobe of lung involved, lesion densities, and radiological patterns, were extracted. Arcsine transformed proportions from individual studies were pooled using a random-effects model to derive pooled proportions (PPs) and 95% confidence intervals (CIs). A total of fifty-four studies (n=2693 confirmed COVID-19 patients) were included in the final review. Prevalence of different CT findings varied across studies; however, the most common findings were bilateral pulmonary involvement (PP: 74.1% [68.4%, 79.5%]; I2 = 85.76%), ground glass opacification (PP: 64.6% [57.6%, 71.4%]; I2 = 91.52%), involvement of the left lower lobe (PP: 71.2% [58.9%, 82.1%]; I2 = 90.91%), and subpleural distribution of lesions (PP: 57.2% [39.0%, 74.3%]; I2 = 93.08%). Multivariate meta-regression revealed a positive association between prevalence of air bronchograms and average age of the population (p=0.013). Bilateral ground glass opacification, a subpleural distribution of lesions, and involvement of the left lower lobe were the most notable chest CT findings in COVID-19 patients.