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Objectives: With widespread vaccination against COVID-19, concerns regarding side effects have been raised. We aim to assess the frequency of otolaryngologic adverse events (AEs) following COVID-19 vaccination as compared with other vaccines in a national database., Study Design: Retrospective analysis of national registry., Methods: The Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS) database was queried from December 2020 to May 2021 for all COVID-19 vaccination AEs. Complaints were categorized as otolaryngologic and sub stratified into different anatomic components. Reporting odds ratios (ROR) and proportional reporting ratios (PRR) were determined for AEs of clinical significance., Results: The total number of AEs reported from vaccination with the Moderna, Pfizer-BioNTech, and Janssen vaccines equaled 1,280,950. Of these, 62,660 (4.9%) were otolaryngologic in nature, with 32.6% associated with the oropharynx/larynx, 18.3% with the nasal cavity/sinuses, 17.1% with the ears/vestibular system, 10.0% with the oral cavity, and 21.9% miscellaneous. Signal ratios reached significance levels for dysgeusia (n = 2124, PRR: 17.33, ROR: 16.36), ageusia (n = 1376, PRR: 2.81, ROR: 2.81), anosmia (n = 983, PRR: 4.01, ROR: 4.01), rhinorrhea (n = 2203, PRR: 2.99, ROR: 3.00), throat tightness (n = 3666, PRR: 4.99, ROR: 5.00), throat irritation (n = 3313, PRR: 4.51, ROR: 4.52), dysphagia (n = 2538, PRR: 2.07, ROR: 2.07), tinnitus (n = 4377, PRR: 3.97, ROR: 3.98), and vertigo (n = 2887, PRR: 3.93, ROR: 3.93). Signal ratios were not significant for facial paralysis, Bell's palsy, anaphylaxis, sinusitis, hearing disability, and ear pain., Conclusions: Although several otolaryngologic symptoms were reported, few were found to be clinically significant. Of note, facial paralysis, Bell's palsy, and anaphylaxis did not meet signal thresholds to be determined significant., Level of Evidence: 4 Laryngoscope, 134:1163-1168, 2024., (© 2023 The American Laryngological, Rhinological and Otological Society, Inc.)

Osseous involvement by diffuse large B-cell lymphoma (DLBCL-bone) is a heterogeneous disease. There is limited data regarding response assessment by positron emission tomography with fluorodeoxyglucose, which may demonstrate residual avidity despite a complete response. We analyzed clinical data of patients with newly diagnosed DLBCL and identified all cases with DLBCL-bone. End of treatment scans were reviewed by two independent experts classifying osseous lesions into Deauville (DV) ≤3; DV ≥4, or reactive uptake in the bone marrow (M), site of fracture (F) or surgery (S). We compared outcomes of DLBCL-bone to other extranodal sites (EN) matched on International Prognotic Index features and regimen. Of 1,860 patients with DLBCL (bone 16%; EN 45%; nodal 39%), 41% had localized disease and 59% advanced. Only 9% (n=27) of patients with initial bone involvement had residual fluorodeoxyglucose avidity at the osseous site. In half of these cases, the uptake was attributed to F/S/M, and of the remaining 13, only two were truly refractory (both with persistent disease at other sites). Overall survival and progression-free survival (PFS) were found to be similar for early- stage nodal DLBCL and DLBCL-bone, but inferior in EN-DLBCL. Advanced-stage disease involving the bone had a similar 5-year PFS to nodal disease and EN-DLBCL. After matching for International Prognotic Index and treatment regiments, PFS between bone and other EN sites was similar. Osseous involvement in DLBCL does not portend a worse prognosis. End of treatment DV ≥4 can be expected in 5-10% of cases, but in the absence of other signs of refractory disease, may be followed expectantly.

Introduction: Vitreous cortex hyalocytes (VCH) are resident macrophage cells that provide immunosurveillance, respond to tissue injury and inflammation, and help maintain the transparency of the media. In this case report we demonstrate the use of en face optical coherence tomography (OCT) to image VCH in vivo in a patient presenting with PAMM secondary to antiphospholipid syndrome., Case Description: A 38-year-old female with no known medical history presented with complaints of visual disturbances in the right eye. OCT revealed hyperreflective bands in the IPL and INL nasal to the fovea. A diagnosis of PAMM was made. Work-up revealed elevated titers of antiphospholipid antibodies. En face OCT revealed a decline in the inflammatory activation over a seven-month period as evidenced by changes in VCH distribution and morphology., Conclusions: Our findings suggest that monitoring changes in the distribution and morphology of VCH could have a potential clinical utility for assessing disease severity, predicting recovery, and early recognition of treatment response in various inflammatory ocular pathologies such as PAMM., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: OOM, SA, LS, AP, TC have no conflicts of interest to declare. RB Rosen has the following commercial relationship(s) to declare: Optovue: Code C (Consultant); Astellas: Code C; (Consultant); Boehringer-Ingerheim:Code C (Consultant); NanoRetina: Code C; OD-OS: Code C; Opticology: Code I (Personal Financial Interest); Regeneron: Code C; Diopsys: Code C (Consultant); Guardion Health: Code C (Consultant); Bayer: Code C (Consultant); Genentech-Roche: Code C (Consultant).

Elucidating the cellular and genetic composition of ocular tissues is essential for uncovering the pathophysiology of ocular diseases. Since the introduction of single-cell RNA sequencing (scRNA-seq) in 2009, vision researchers have performed extensive single-cell analyses to better understand transcriptome complexity and heterogeneity of ocular structures. This technology has revolutionized our ability to identify rare cell populations and to make cross-species comparisons of gene expression in both steady state and disease conditions. Importantly, single-cell transcriptomic analyses have enabled the identification of cell-type specific gene markers and signalling pathways between ocular cell populations. While most scRNA-seq studies have been conducted on retinal tissues, large-scale transcriptomic atlases pertaining to the ocular anterior segment have also been constructed in the past three years. This timely review provides vision researchers with an overview of scRNA-seq experimental design, technical limitations, and clinical applications in a variety of anterior segment-related ocular pathologies. We review open-access anterior segment-related scRNA-seq datasets and illustrate how scRNA-seq can be an indispensable tool for the development of targeted therapeutics., (© 2023. The Author(s).)

Background: Understanding the patterns of IONM use and training among resident otolaryngologists is essential to ensure that the IONM skills and knowledge gained in residency are optimized for successful future practice of IONM., Method: An electronic survey was distributed to US-based OHNS residents. Questions evaluated resident experience, implementation, knowledge and understanding of IONM for endocrine surgeries., Results: One hundred and seven OHNS residents participated, spanning all training levels and US geographic locations. The majority of residents received no didactic teaching on IONM (74.5%) nor had a clear troubleshooting algorithm in the event of a loss of signal (69.8%). The majority of residents were uncertain regarding the advantages/disadvantages of continuous versus intermittent IONM., Conclusion: The knowledge gap found in our survey study suggests that greater teaching of IONM principles for endocrine head and neck surgeries in OHNS residency programs would help to ensure successful utilization in future practice., (© 2023 Wiley Periodicals LLC.)

Purpose: Recent studies of glaucoma, age-related macular degeneration, and diabetic retinopathy have demonstrated that flavoprotein fluorescence (FPF) can be utilized non-invasively as an indicator of mitochondrial oxidative stress in the retina. However, a comprehensive assessment of the validity and reliability of FPF in differentiating between healthy and diseased eyes across multiple disease states is lacking. Here, we evaluate the sensitivity and specificity of FPF in discriminating between healthy and diseased eyes in four leading causes of visual impairment worldwide, one of which has not been previously evaluated using FPF. We also evaluate the association between FPF and visual acuity., Methods: A total of 88 eyes [21 eyes of 21 unaffected controls, 20 eyes from 20 retinal vein occlusion (RVO) patients, 20 eyes from 20 diabetic retinopathy (DR) patients, 17 eyes from 17 chronic exudative age-related macular degeneration (exudative AMD) patients, and 10 eyes from 10 central serous retinopathy (CSR) patients] were included in the present cross-sectional observational study. Eyes were imaged non-invasively using a specially configured fundus camera OcuMet Beacon ® (OcuSciences, Ann Arbor, MI). The macula was illuminated using a narrow bandwidth blue light (455 - 470 nm) and fluorescence was recorded using a narrow notch filter to match the peak emission of flavoproteins from 520 to 540 nm. AUROC analysis was used to determine the sensitivity of FPF in discriminating between diseased eyes and healthy eyes. Nonparametric Kruskal-Wallis Tests with post-hoc Mann Whitney U tests with the Holm-Bonferroni correction were performed to assess differences in FPF intensity, FPF heterogeneity, and best corrected visual acuity (BCVA) between the five groups. Spearman rank correlation coefficients were calculated to assess the relationship between FPF and BCVA., Results: AUROC analysis indicated that FPF intensity is highly sensitive for detecting disease, particularly for exudative AMD subjects (0.989; 95% CI = 0.963 - 1.000, p =3.0 x 10 7 ). A significant difference was detected between the FPF intensity, FPF heterogeneity, and BCVA in all four disease states compared to unaffected controls (Kruskal-Wallis Tests, p = 1.06 x 10 -8 , p = 0.002, p = 5.54 x 10 -8 , respectively). Compared to healthy controls, FPF intensity values were significantly higher in RVO, DR, exudative AMD, and CSR ( p < 0.001 , p < 0.001 , p < 0.001, and p = 0.001, respectively). Spearman rank correlation coefficient between FPF intensity and BCVA was ρ = 0.595 ( p = 9.62 x 10 -10 )., Conclusions: Despite variations in structural retinal findings, FPF was found to be highly sensitive for detecting retinal disease. Significant FPF elevation were seen in all four disease states, with the exudative AMD patients exhibiting the highest FPF values compared to DR, CSR, and RVO subjects. This is consistent with the hypothesis that there is elevated oxidative stress in all of these conditions as previously demonstrated by blood studies. FPF intensity is moderately correlated with the late-in disease-marker BCVA, which suggests that the degree of FPF elevation can be used as a metabolic indicator of disease severity., Competing Interests: RR has the following commercial relationships to declare: Optovue: Code C Consultant; Astellas: Code C; Consultant; Boehringer-Ingerheim : Code C Consultant; CellView: Code C; OD-OS: Code C; Opticology: Code I Personal Financial Interest; Regeneron: Code C; Lumithera: Code C Consultant; Guardion Health: Code C Consultant; Bayer: Code C Consultant; Genentech-Roche: Code C Consultant. CR has the following commercial relationships to declare: OcuSciences: Code I Personal Financial Interest. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Ahsanuddin, Rios, Otero-Marquez, Macanian, Zhou, Rich and Rosen.)

Objectives: Open repair of mandibular fractures are frequently performed surgical procedures. Increasing rates of such fractures are seen in older adults following falls. This study assesses the impact of older age on early complications following mandible fracture repair., Study Design: Retrospective analysis of national registry., Methods: The 2013-2018 National Surgical Quality Improvement Program database was queried for all cases of open mandible fracture repair and cases were categorized into younger (18-40), middle (41-65), and older (>65) age cohorts. Demographics and comorbidities were compared between the age groups. Rates of surgical, medical, and wound complications within 30-days of surgery were determined. Multivariable logistic analyses were performed to assess the relationship between age and complications., Results: Altogether, 1818 cases were included for analysis, of which 1269 (69.8%) were younger, 459 (25.2%) were middle, and 90 (5.0%) were older age. Increased rates of complications were seen in the older groups, including unplanned reoperation, unplanned readmission, wound disruption, and medical complications (p < 0.01). On unadjusted analysis, the older (>65) age group had an increased odds of experiencing a complication compared to the younger (18-40) group (OR: 4.19, p < 0.001). The older age group continued to have a significantly increased odds of medical complications after multivariable adjustment (adjusted OR: 8.64, p < 0.001)., Conclusions: On this analysis of a national database, advanced age was associated with an increased frequency of early postoperative complications following open mandibular fracture repair. Following multivariable adjustment, advanced age continued to be associated with increased odds of postoperative medical complications within 30 days of surgery., Level of Evidence: 3 Laryngoscope, 133:287-293, 2023., (© 2022 The American Laryngological, Rhinological and Otological Society, Inc.)

Presurgical Nasoalveolar Molding (NAM) is an adjunctive treatment modality designed to reorient misaligned tissue structures and nasal cartilage in cleft lip and/or palate (CL/P) patients. Recent advances in NAM therapy focus on modifications to the intraoral molding plate or nasal stent intended to improve treatment outcomes, ease of use, compliance, and cost-effectiveness. Notably, 3D technological advancements have been employed to design NAM devices more efficiently and create objective, standardized means of measuring progressive morphological changes during therapy. These advances are designed to incorporate 3D technology in the treatment of cleft lip and/or palate to render it more precise, accurate, and time-efficient., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2021.)

Background: Surgical scheduling, specifically the day of the week on which surgery is performed, has been associated with various postoperative outcomes in patients undergoing lower extremity joint arthroplasty., Purpose: We sought to investigate surgical scheduling as a potential modifiable factor for patient quality metrics and related costs., Methods: In a retrospective prognostic study, all total knee and total hip arthroplasty (TKA/THA) cases that took place in 2017 to 2018 at a multihospital academic health system were queried. Patients were separated by the day of the week the surgery was performed, with Monday/Tuesday compared to Thursday/Friday. Outcomes included length of stay (LOS) (extended LOS defined as 3 days or longer), cost, and complications. Multivariable regression models measured associations between scheduling of surgery and outcomes; odds ratios (OR) and 95% confidence intervals (CIs) are reported., Results: Overall, 1,571 TKA and 992 THA patients were included (65% and 35%, respectively, performed on Monday/Tuesday and 70% and 30%, respectively, performed on Thursday/Friday). Patients undergoing TKA on Monday/Tuesday versus Thursday/Friday had higher American Society of Anesthesiologists scores (42% vs 33% with score of 3 or higher) but less often an extended LOS (31% vs 54%; adjusted OR: 2.76, 95% CI: 2.22-3.46), lower skilled nursing facility costs (unadjusted mean, $12,515 vs $14,154) and lower home health aide costs (unadjusted mean, $3,793 vs $4,192). Similar patterns were observed in THA patients., Conclusion: These results from institutional data suggest that surgical scheduling is a modifiable factor possibly associated with postoperative outcomes. Furthermore, more rigorous study is warranted., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Sofia Ahsanuddin, BA; Hsin-Hui Huang, MD, PhD; Aakash Keswani, MD; Jashvant Poeran, MD, PhD; and Daniel J. Snyder, BS, declare they have nothing to disclose. Calin S. Moucha, MD, reports relationships with 3M and Biocomposites., (© The Author(s) 2021.)

Background: There is currently limited population-based data on the effect of type 2 diabetes mellitus (T2DM) on bullous pemphigoid (BP) inpatients., Aims: To evaluate the relative comorbidities, medical complications, and mortality rates between BP inpatients with and without T2DM., Methods: All inpatients with a primary BP diagnosis in the National Inpatient Sample from 2003 to 2012 were queried. BP inpatients with or without T2DM were compared to identify disparities in relative comorbidities and medical complications. Comorbidities were established using the Agency for Healthcare Research and Quality standardized values. Medical complications were classified using ICD-9 codes., Results: Of the 1978 BP patients identified, 660 (33.4%) had a concurrent diagnosis of T2DM. These patients had significantly higher rates of concurrent comorbidities, including chronic renal failure, congestive heart failure, iron deficiency anemia, hypertension, obesity, and peripheral vascular disease. On bivariate analysis, T2DM patients also had significantly higher rates of medical complications including acute kidney injury (14.5% vs. 10.1%, p = 0.004) and venous thromboembolism (1.8% vs. 0.5%, p = 0.012). On multivariable-adjusted analysis, the odds of venous thromboembolism (OR = 3.01, p = 0.027) remained increased. Inpatient mortality did not differ between the groups., Conclusions: Our findings suggest that BP inpatients with T2DM have a greater medical comorbidity and complication burden. However, inpatient mortality was not increased., (© 2021. Royal Academy of Medicine in Ireland.)

Background: Work relative value units (wRVUs) are linked to clinical reimbursements and physician compensation in the USA and thus should consider the time of the physician providing care. The primary goal of this study is to assess whether wRVUs appropriately consider operative time in plastic and reconstructive surgery., Methods: The 2015-2018 National Surgical Quality Improvement Program was queried for the 50 most performed plastic surgery cases with assigned wRVUs and a recorded operative time. Linear regressions were used to assess the relationships between operative time, assigned wRVUs, and wRVUs per hour. The procedures with the highest and lowest assigned wRVUs relative to their operative time were identified., Results: A total of 31,156 cases were included in this analysis. Among the 50 most performed procedures, the median (range) for assigned wRVUs was 10.0 (1.0-42.6), operative time was 61 min (21-441), and wRVUs per hour was 8.7 (2.2-16.2). There was a strong positive linear correlation between assigned wRVUs and median operative time (R 2 =0.78), with each additional operative hour being associated with an increase of 5.3 wRVUs (p<0.001). The procedures earning the most wRVUs relative to their operative times were breast reconstruction with other techniques and tissue expander placement in breast reconstruction. However, excisional debridements of the muscle/fascia and subcutaneous tissue had the lowest earned wRVUs relative to their operative times., Conclusion: Although wRVUs and operative time are correlated in plastic surgery, numerous outliers from this trend exist. This suggests that wRVUs may not be optimally assigned across the range of plastic surgery procedures., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Objective: To analyze population-level data for Burkitt's lymphoma of the head and neck., Study Design: Retrospective study of a national cancer database., Setting: Academic medical center., Methods: The SEER database (Surveillance, Epidemiology, and End Results) identified all patients with primary Burkitt's lymphoma of the head and neck from 1975 to 2015. Demographic, clinicopathologic, and treatment characteristics were analyzed. Multivariable Cox regressions analyzed factors associated with survival while controlling for baseline differences., Results: A total of 920 patients with a mean (SD) age of 37.6 years (25.0) were identified. A majority of patients were White (82.8%) and male (72.3%). The most primary common sites included the lymph nodes (61.3%), pharynx (17.7%), and nasal cavity/paranasal sinuses (5.2%). The majority of patients received chemotherapy (90.5%), while fewer underwent surgery (42.1%) or radiotherapy (12.8%). Choice of treatment differed significantly among patients of different ages, year of diagnosis, primary site, nodal status, and Ann Arbor stage. Overall 10-year survival was 67.8%. On multivariable Cox regression, patients with older age (hazard ratio [HR], 1.05 per year; P < .001) and higher stage at presentation had increased risk of mortality ( P < .001). Furthermore, cases diagnosed between 2006 and 2015 (HR, 0.35; P < .001) and 1996 and 2005 (HR, 0.53; P = .001) had lower mortality when compared with those diagnosed between 1975 and 1995. Treatment including surgery and chemotherapy tended to have the best survival ( P < .001)., Conclusion: Burkitt's lymphoma of the head and neck diagnosed in more recent years has had improved survival. Factors significantly associated with survival include age, Ann Arbor stage, and treatment regimen. Treatment including surgery and chemotherapy was associated with the highest survival.

Purpose: The optimal age for minimally invasive repair of pectus excavatum (MIRPE) is unclear; this study investigates the differences in complication rates among different age groups undergoing repair., Methods: PubMed and Embase databases were searched from inception to October 2020. To assess age as a risk factor for complications, odds ratios from relevant studies were analyzed using the Mantel-Haenszel method with a random-effects model for younger vs older patients. Specific complication rates were compared between the two cohorts using a chi-squared test., Results: Of the 4448 studies retrieved, 25 studies stratified complication data by age groups. From these studies, ten studies compared groups at ages < 18 and ≥ 18 and four studies compared ages < 20 and ≥ 20, and one study compared ages < 19 and ≥ 19. These fifteen studies reported on 5978 patients, with 1188 complications, for a complication rate of 19.87%. Older patients were more likely to have complications in a pooled analysis of studies comparing older vs younger patients (OR = 1.66, 95% CI = 1.28-2.14, heterogeneity I 2  = 49%). Specifically, older patients were significantly more likely to experience pneumothorax, pleural effusion, wound infection, bar displacement, and reoperations., Conclusion: Increased age is a risk factor for complications of MIRPE. This supports repair of pectus excavatum prior to late adolescence., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction and Objective: Scant literature is available on surgical outcomes of radical cystectomies on the new single-port (SP) system. This study compares short-term outcomes in patients undergoing radical cystectomy with those undergoing intracorporeal urinary diversion (ICUD) on the multiport (MP) vs SP platform. Methods: This institutional review board approved study used a prospective cystectomy database and nonparametric testing including chi-squared, Mann-Whitney U, and Fisher exact tests to analyze all variables stratified by surgical approach. Results: Thirty-four patients underwent radical cystectomy with ICUD from September 1, 2019, to February 8, 2021. Twenty patients were in the MP cohort, whereas 14 were in the SP group. Table 1 presents the demographics of both groups and shows no statistically significant differences. Intra- and postoperative as well as pathology data are given in Table 2. Patients in the SP group had less narcotic use (MP: 25 morphine milligram equivalent [MME] vs SP: 11.5 MME, p  = 0.047) and shorter return of bowel function (MP: 3 days vs SP: 2 days, p  = 0.032). Operative times were similar between both groups despite having fewer patients undergoing ileal conduit (MP: 85% vs SP: 50%, p  = 0.027) in the SP group. In Table 3, we list the early short-term postoperative follow-up data for each group that showed no significant differences between the two groups with an average follow-up of 4.9 months for MP and 4.4 months for SP. Conclusions: Our initial experience with SP robotic cystectomy and ICUD appears to be safe and an effective alternative to MP cystectomies. A learning curve was involved but the overall transition from MP to SP was smooth. Operative times were similar despite fewer patients undergoing ileal diversion, shorter return of bowel function, and less narcotic use in the SP group. Further studies including longer follow-ups with multi-institutional data are underway.

Background: Using a population-based database, this study investigates the risk factors, epidemiology, and outcomes of basal cell adenocarcinoma (BCAC) of the head and neck., Methods: The Surveillance, Epidemiology, and End Results database was analyzed for all patients with BCAC of the head and neck from 1973 to 2015., Results: Three hundred and twenty-two cases of BCAC of the head and neck were identified. Mean age of diagnosis was 64.1 years. 52.5% were male and 77.3% were white. The most common primary site was the parotid gland (71.7%). Most patients underwent surgery alone (51.9%). Five-year disease-specific survival (5Y-DSS) was 95.6%, and 10Y-DSS was 90.3%. Highest survival was seen with surgery alone followed by combined surgery and radiation (10Y-DSS: 93.9% vs. 88.9%, p = 0.001). Age, primary site, T-classification, grade, and treatment type significantly affected survival., Conclusions: BCAC of the head and neck presents most frequently in the parotid glands. Surgery alone is associated with highest survival., (© 2021 Wiley Periodicals LLC.)

Background: Vaccinations are a cornerstone of preventative medicine in the USA. However, growing concerns regarding facial nerve palsy following vaccination exist., Objective: This study aims to assess the occurrence of facial palsy as reported by the Vaccine Adverse Event Reporting System (VAERS) database., Methods: A retrospective analysis of the VAERS database was performed for cases of 'Facial Palsy', 'Bell's Palsy', 'Facial Paralysis' and 'Ramsay Hunt Syndrome' between 2009 and 2018. Subgroup analysis was performed to determine gender, age, history of facial palsy, type of vaccine used, number of days until onset of symptoms and overall facial palsy rate., Results: Nine hundred and forty-four entries met our inclusion criteria with 961 vaccine administrations resulting in facial paralysis. Facial palsy following vaccinations was evenly distributed across all age cohorts with two peaks between 60 and 74 years old and between 0 and 14 years old. Most patients were female (N = 526, 55.7%) without a reported history of facial palsy (N = 923, 97.8%). In 2009, reported incidence rate was 0.53%, as compared with 0.23% in 2018. The influenza vaccine had the greatest number of cases (N = 166, 17.3%), followed by the varicella (N = 87, 9.1%) and human papillomavirus vaccines (N = 47, 4.9%)., Conclusions: With the SARS-CoV-2 pandemic and recent approvals of the vaccinations, there is growing concern of facial palsy following vaccination. Although it is a known adverse event following vaccination, the likelihood of facial palsy following vaccination is low, with only 0.26% of overall reported cases over a 10-year span., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.)

Background: Intranasal sprays (INSs) are commonly used medications for the treatment of many rhinologic conditions. Despite their popularity, an analysis of a nationwide reporting database and comparison to the available literature has never been performed., Methods: The Food and Drug Administration Adverse Event Reporting System (FAERS) database was accessed to obtain adverse event (AE) records from 2014 to 2019 for varying INSs, including: 10 corticosteroids, 1 alpha adrenergic, and 3 antihistamines. The Proportional Reporting Ratios (PRR) and Reporting Odds Ratios (ROR) were calculated for dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache. A PRR ≥ 2 or ROR ≥ 1 was considered significant., Results: Corticosteroids had 98 864 total reported AEs to the database, followed by antihistamines (7011) and alpha adrenergics (2071). In total, dyspnea was reported 5843 times, followed by headache (4230), epistaxis (1205), ageusia/dysgeusia (920), and anosmia (312). Overall, PRR and ROR values for dyspnea ranged from 0.51 to 4.25 and 0.51 to 4.49; for dysgeusia/ageusia from 0.56 to 6.09 and 0.56 to 6.12; and for epistaxis from 1.03 to 27.24 and 1.03 to 30.76, respectively. All medications which listed anosmia within the top AEs had PRR and ROR values exceeding 2 and 1, respectively. The PRR for headache exceeded 2 for 1 medication and the ROR exceeded 1 in 7 medications., Conclusion: The AEs of dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache are reported within the FAERS database for commonly prescribed INSs. When compared against the existing scientific literature, the clinical significance of this reporting tool from the FDA for these classes of medications remains unvalidated.

Objectives: Sinonasal mucosal melanoma (SNMM) is an aggressive cancer usually managed with surgical resection. This study evaluates the impact of treatment modality and positive surgical margin (PSM) on survival following resection of SNMM., Study Design: Retrospective study of a national cancer registry., Methods: The National Cancer Database was queried for cases of SNMM from 2010 to 2015. Data regarding patient demographics, tumor staging, and treatment modality were obtained. Survival rates were compared by margin status: PSM, negative (NSM), and no operation (0SM) using Kaplan-Meier analysis and log rank test., Results: A total of 446 patients met inclusion criteria. Most cases were elderly (>66 years-old) (67.3%), female (54.3%), and white (89.5%). Cases of SNMM most commonly involved the nasal cavity (81.6%), were Stage 3 (60.0%), and underwent surgical resection at an academic center (65.0%). NSM and PSM were present in 59.0% and 26.9% of cases, respectively, while 14.1% of cases did not undergo surgical resection (0SM). Factors predictive of PSM included resection at a community hospital (OR 2.47) and Stage 4 disease (OR 2.07). The 2-year survival rates were 72.1% (95% CI 69.4-75.4%), 36.3% (95% CI 22.0-48.9), and 16.0% (95% CI 8.2-25.4%) for NSM, PSM and 0SM, respectively. Survival was statistically significant between NSM and PSM (Log rank <0.001) but not between 0SM and PSM (Log rank = 0.062)., Conclusion: Our study emphasizes the need for NSM for SNMM as PSM did not demonstrate any significant improvement in survival when compared to 0SM. Our findings suggest that cases of SNMM are best managed at academic centers., Level of Evidence: 4 Laryngoscope, 131:2429-2435, 2021., (© 2021 The American Laryngological, Rhinological and Otological Society, Inc.)

Background: With an ever-growing reliance on technology, patients are increasingly resorting to websites for their medical information. This study evaluates the readability, quality, and reliability of online information available on rhinoplasty provided by academic centers or impartial reference sources and private practice websites., Methods: A cross-sectional study from July to August 2019 was performed looking at the first 42 informational websites on a Google search for the term nose job. Websites were categorized as belonging to impartial sources and academic centers or private practices. Two independent reviewers evaluated websites on their quality, readability, reliability, and technical qualities using several validated measures. The Health on the Net code (HONcode) and DISCERN questionnaire were used to assess the quality and reliability of the information presented on the websites. Significance tests were performed using SPSS Version 25., Results: Of the 42 websites, 23 were impartial sources or academic centers (54.8%) and 19 were private practice websites (47.6%). The mean (±SD) for the HONcode and DISCERN scores were 5.7 (±2.8) and 2.6 (±0.7), respectively. The mean (SD) HONcode scores for impartial sources and private practice websites were 7.1 (±2.9) and 4.1 (±1.5), respectively (P < 0.001). The mean (±SD) DISCERN scores were 2.9 (±0.7) and 2.3 (±0.5), respectively (P = 0.009). There was no statistically significant difference in scores for readability and technical qualities., Conclusions: While impartial sources and academic centers score higher on quality and reliability scores, their scores were also low. These findings are concerning as many consumers use the information provided by online websites to guide decisions regarding their health., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 by Mutaz B. Habal, MD.)

Background: Giant cell sarcomas (GCS) are rare head and neck neoplasms., Methods: The Surveillance, Epidemiology, and End Results (SEER) database was analyzed for all patients who have been diagnosed with GCS from 1973 to 2014., Results: Four hundred and forty cases of GCS of the head and neck were identified. The average age at diagnosis was 74.4 years, 86.8% were white, 82.5% were male, 70.7% were insured, and 88.2% lived in an urban metropolitan region. Connective tissue was the most frequent primary site (42.5%). The 5Y-DSS rate was 91.1%, while the 5Y-OS was 54.6% for all cases. Patients treated with surgery alone had the highest 5Y-DSS rate of 94.5. T-classification odds ratio was a significant predictor of survival accounting for confounding variables on multivariate analysis., Conclusions: GCS presents most frequently in connective tissue of the head and neck with overall high probability of survival. The treatment of choice is surgery alone., (© 2021 Wiley Periodicals LLC.)

Purpose: With an increasing rate of obesity in the USA, bariatric surgery has become widespread, resulting in a greater number of patients seeking panniculectomy. The authors aim to determine the complication profile of panniculectomies by body mass index (BMI)., Methods: The 2012-2018 National Surgical Quality Improvement Program database was queried for all panniculectomy cases. Patients were assigned to a category by their calculated BMI. Rates of complications were compared across BMI ranges. Demographics, comorbidities, and perioperative factors were compared between those with and without complications. Multivariable analyses were performed to analyze the associations between BMI ranges and post-surgical complications., Results: Twelve thousand seven hundred thirty-two cases were analyzed, of which 1759 (13.8%) had at least one postoperative complication. As BMI increased, patients were more likely to experience postoperative complications (p<0.001). Patients experiencing complications were more likely to be male, older, of a higher BMI group, have a higher American Society of Anesthesiologists Personal Status classification, be an inpatient, have various comorbidities, or be undergoing a concurrent procedure. On multivariable analysis, patients who were overweight (OR=1.24, p=0.039), with class 1 (OR=1.72, p<0.001), class 2 (OR=2.10, p<0.001), or class 3 (OR=3.01, p<0.001) obesity were more likely to have a postoperative complication. Wound complications were particularly prevalent in patients who were overweight (OR=1.77, p=0.001) or with class 1 (OR=2.59, p<0.001), class 2 (OR=4.05, p<0.001), or class 3 (p=5.84, p<0.001) obesity compared to non-overweight patients., Conclusion: A higher BMI is associated with more postoperative complications, particularly wound healing complications, following panniculectomy in a dose-dependent manner., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

We present a global atlas of 4,728 metagenomic samples from mass-transit systems in 60 cities over 3 years, representing the first systematic, worldwide catalog of the urban microbial ecosystem. This atlas provides an annotated, geospatial profile of microbial strains, functional characteristics, antimicrobial resistance (AMR) markers, and genetic elements, including 10,928 viruses, 1,302 bacteria, 2 archaea, and 838,532 CRISPR arrays not found in reference databases. We identified 4,246 known species of urban microorganisms and a consistent set of 31 species found in 97% of samples that were distinct from human commensal organisms. Profiles of AMR genes varied widely in type and density across cities. Cities showed distinct microbial taxonomic signatures that were driven by climate and geographic differences. These results constitute a high-resolution global metagenomic atlas that enables discovery of organisms and genes, highlights potential public health and forensic applications, and provides a culture-independent view of AMR burden in cities., Competing Interests: Declaration of interests C.E.M. is co-founder of Biotia and Onegevity Health. D.B. is co-founder and CSO of Poppy Health Inc. The other authors declare they have no competing interests that impacted this study., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Botulinum toxin treatment is the most frequently performed noninvasive cosmetic procedure performed in the USA. Because of its widespread use, an analysis of the adverse event (AE) profile of Botox injections is needed., Methods: The FDA Adverse Event Report System was queried using an online web-based tool to determine the top 15 adverse events reported for four Botox brand names: Botox/Botox Cosmetic, Dysport, and Xeomin. The proportional reporting ratios (PRR) and relative odds ratios (ROR) were determined. A literature review was performed for eight AEs of clinical significance: eyelid/eyebrow ptosis, asthenia, muscular weakness, facial paresis, dysphagia, botulism, and death., Results: Botox/Botox Cosmetic had 38367 AEs. Dysport had 3582 AEs. Xeomin had 1405 AEs. All drugs with reported cases of eyelid and eyebrow ptosis had significant PRR and ROR values. The PRR and ROR values for asthenia were not significant in any of the drugs and only reached significance for Dysport for muscular weakness and dysphagia. Both Botox/Botox Cosmetic and Dysport had elevated PRRs and RORs for facial paresis and botulism. While all drugs had at least one reported case of death related to Botox injection use, none of the PRR or ROR values were significant., Conclusion: Known AEs for Botox injection use include eyelid/brow ptosis and muscular weakness. Feared but rare complications of Botox injection use include dysphagia, botulism, and possibly death, owing to systemic spread of the toxin. This is the first study to analyze the AE data reported to the FDA on Botox injection use., Ebm Level: III.

Summary: Since the introduction of the Bundled Payments for Care Improvement initiative, progress has been made in piloting bundled payment models to improve care coordination and curtail health care expenditures. In light of improvements in patient outcomes and the concomitant reduction in health care spending for certain high-volume and high-cost procedures, such as total joint arthroplasty and breast reconstruction, the authors discuss theoretical considerations for bundling payments for the care of patients with orofacial clefts. The reasons for and against adopting such a payment model to consolidate cleft care, as well as the challenges to implementation, are discussed. The authors purport that bundled payments can centralize components of cleft care and offer financial incentives to reduce costs and improve the value of care provided, but that risk adjustment based on the longitudinal nature of care, disease severity, etiologic heterogeneity, variations in outcomes reporting, and varying definitions of the episode of care remain significant barriers to implementation., Competing Interests: Disclosure:The authors have no financial disclosures or conflicts of interest to report., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Previous studies have identified older age as a negative prognostic factor in malignant melanoma patients. To compare comorbidities, medical complications, and inpatient mortality between younger and older malignant melanoma inpatients. All adult patient encounters with a diagnosis of cutaneous malignant melanoma were identified using the 2003 to 2012 National Inpatient Sample database. Concurrent comorbidities and inpatient medical complications were queried. Comparisons were made between older and younger adults, defined as ≥65 years and 18 to 64 years, respectively. In total, 8153 patient encounters were identified in the database (51.6% older and 48.4% younger). Older adults had a higher prevalence of numerous comorbidities, including chronic pulmonary disease, chronic renal failure, congestive heart failure, diabetes mellitus, hypertension, hypothyroidism, peripheral vascular disease, and pulmonary circulation disorder (P < .001). In contrast, younger adults were more likely to have obesity (P < .001) and coagulopathy (P = .005). On multivariable analysis of medical complications, older adult inpatients were more likely to experience urinary tract infection (OR = 1.54, P = .021), but less likely to experience acute respiratory failure (OR = 0.46, P = .012) and venous thromboembolism (OR = 0.44, P = .026). Notably, inpatient mortality did not significantly differ. Older adult inpatients with malignant melanoma have different comorbidities than younger patients and have a larger overall comorbidity burden. Surprisingly, however, the odds of most inpatient medical complications and mortality were found to be similar in younger vs older patients., (© 2020 Wiley Periodicals LLC.)

Poor sleep quality is extremely prevalent, with about one third of adults in the USA obtaining less than the recommended amount of sleep. In addition, poor sleep quality has been linked to an increased risk of many conditions, including diabetes, hypertension, psychiatric conditions, and overall all-cause mortality. Research has shown that sleep disturbance does impact skin disease, although many details of this relationship are still unclear. The goal of this study is to determine if there is a relationship between acne severity and sleep quality in adults. Forty subjects with acne were recruited from dermatology clinics in Cleveland, OH, to participate in this study. Acne severity was assessed using the Global Acne Grading Scale (GAGS). To assess sleep quality, subjects completed the Pittsburgh Sleep Quality Index (PSQI) and completed a seven-day sleep journal. Subjects also completed the Dermatology Life Quality Index (DLQI), the Patient Health Questionnaire-2 (PHQ-2), and provided information about current and past acne treatments as well as their opinion regarding their own acne severity and exacerbating factors. Our findings support the hypothesis that there is a potential relationship between sleep quality and acne., Competing Interests: Conflicts of InterestThe authors declare that there was no conflict of interest regarding the publication of this article. The funding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results., (© 2019 by the authors.)

Introduction: Nasoalveolar molding (NAM) is a presurgical orthopedic treatment modality that attempts to reorient misaligned bony and soft tissue structures in patients with clefting of the lip and palate. The NAM devices are implemented prior to surgical intervention in order to minimize the gap across the cleft and thereby reduce tension across the eventual repair. Currently, NAM devices are fabricated in a laboratory and then refined chairside by the provider. The present article describes the potential of three-dimensional (3D) printing and computer-aided design (CAD) software for the fabrication of NAM devices., Material and Methods: A workflow was developed to demonstrate the use of 3D printing and CAD software to design NAM devices. This workflow encompasses scanning an impression into CAD software, performing a series of manipulations, and then printing the digital model., Results: To test the workflow, a cleft palate plaster model was scanned into CAD software. Through a series of linear and angular freeform manipulations of the body, the model was modified to display a cleft with a reduced alveolar gap. Sequential molding devices were produced which would gradually apply pressure to targeted areas of hard and soft tissue until the cleft is minimized. The resulting devices are printed using a stereolithography printer., Conclusions: The use of 3D printing and CAD software shows promise in improving the accuracy, speed, and cost-effectiveness of designing NAM devices. The accuracy and flexibility from digitally visualizing the manipulations made to an appliance before its creation can result in a more personalized device for the patient.

Following publication of the original article [1], the authors would like to highlight the following two corrections.

The diverse immunomodulatory effects of vitamin D are increasingly being recognized. However, the ability of oral vitamin D to modulate acute inflammation in vivo has not been established in humans. In a double-blinded, placebo-controlled interventional trial, 20 healthy adults were randomized to receive either placebo or a high dose of vitamin D 3 (cholecalciferol) one hour after experimental sunburn induced by an erythemogenic dose of UVR. Compared with placebo, participants receiving vitamin D 3 (200,000 international units) demonstrated reduced expression of proinflammatory mediators tumor necrosis factor-α (P = 0.04) and inducible nitric oxide synthase (P = 0.02) in skin biopsy specimens 48 hours after experimental sunburn. A blinded, unsupervised hierarchical clustering of participants based on global gene expression profiles revealed that participants with significantly higher serum vitamin D 3 levels after treatment (P = 0.007) demonstrated increased skin expression of the anti-inflammatory mediator arginase-1 (P = 0.005), and a sustained reduction in skin redness (P = 0.02), correlating with significant expression of genes related to skin barrier repair. In contrast, participants with lower serum vitamin D 3 levels had significant expression of proinflammatory genes. Together the data may have broad implications for the immunotherapeutic properties of vitamin D in skin homeostasis, and implicate arginase-1 upregulation as a previously unreported mechanism by which vitamin D exerts anti-inflammatory effects in humans., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: One of the main challenges in metagenomics is the identification of microorganisms in clinical and environmental samples. While an extensive and heterogeneous set of computational tools is available to classify microorganisms using whole-genome shotgun sequencing data, comprehensive comparisons of these methods are limited., Results: In this study, we use the largest-to-date set of laboratory-generated and simulated controls across 846 species to evaluate the performance of 11 metagenomic classifiers. Tools were characterized on the basis of their ability to identify taxa at the genus, species, and strain levels, quantify relative abundances of taxa, and classify individual reads to the species level. Strikingly, the number of species identified by the 11 tools can differ by over three orders of magnitude on the same datasets. Various strategies can ameliorate taxonomic misclassification, including abundance filtering, ensemble approaches, and tool intersection. Nevertheless, these strategies were often insufficient to completely eliminate false positives from environmental samples, which are especially important where they concern medically relevant species. Overall, pairing tools with different classification strategies (k-mer, alignment, marker) can combine their respective advantages., Conclusions: This study provides positive and negative controls, titrated standards, and a guide for selecting tools for metagenomic analyses by comparing ranges of precision, accuracy, and recall. We show that proper experimental design and analysis parameters can reduce false positives, provide greater resolution of species in complex metagenomic samples, and improve the interpretation of results.

The Extreme Microbiome Project (XMP) is a project launched by the Association of Biomolecular Resource Facilities Metagenomics Research Group (ABRF MGRG) that focuses on whole genome shotgun sequencing of extreme and unique environments using a wide variety of biomolecular techniques. The goals are multifaceted, including development and refinement of new techniques for the following: 1) the detection and characterization of novel microbes, 2) the evaluation of nucleic acid techniques for extremophilic samples, and 3) the identification and implementation of the appropriate bioinformatics pipelines. Here, we highlight the different ongoing projects that we have been working on, as well as details on the various methods we use to characterize the microbiome and metagenome of these complex samples. In particular, we present data of a novel multienzyme extraction protocol that we developed, called Polyzyme or MetaPolyZyme. Presently, the XMP is characterizing sample sites around the world with the intent of discovering new species, genes, and gene clusters. Once a project site is complete, the resulting data will be publically available. Sites include Lake Hillier in Western Australia, the "Door to Hell" crater in Turkmenistan, deep ocean brine lakes of the Gulf of Mexico, deep ocean sediments from Greenland, permafrost tunnels in Alaska, ancient microbial biofilms from Antarctica, Blue Lagoon Iceland, Ethiopian toxic hot springs, and the acidic hypersaline ponds in Western Australia.

Next-generation sequencing (NGS) technologies have ushered in the era of precision medicine, transforming the way we treat cancer patients and diagnose disease. Concomitantly, the advent of these technologies has created a surge of microbiome and metagenomic studies over the last decade, many of which are focused on investigating the host-gene-microbial interactions responsible for the development and spread of infectious diseases, as well as delineating their key role in maintaining health. As we continue to discover more information about the etiology of infectious diseases, the translational potential of metagenomic NGS methods for treatment and rapid diagnosis is becoming abundantly clear. Here, we present a robust protocol for the implementation and application of "precision metagenomics" across various sequencing platforms for clinical samples. Such a pipeline integrates DNA/RNA extraction, library preparation, sequencing, and bioinformatics analyses for taxonomic classification, antimicrobial resistance (AMR) marker screening, and functional analysis (biochemical and metabolic pathway abundance). Moreover, the pipeline has 3 tracks: STAT for results within 24 h; Comprehensive that affords a more in-depth analysis and takes between 5 and 7 d, but offers antimicrobial resistance information; and Targeted, which also requires 5-7 d, but with more sensitive analysis for specific pathogens. Finally, we discuss the challenges that need to be addressed before full integration in the clinical setting.