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Objective: While management protocols of pediatric esophageal foreign bodies (EFBs) are well-delineated, resource utilization can be improved. This study's objectives were to explore hospital charges/costs for pediatric patients who present with EFBs and to identify patient risk factors associated with esophageal injury., Methods: A retrospective chart review of patients undergoing aerodigestive foreign body removal at a tertiary-care children's hospital from 2018 to 2021 was conducted. Data collected included demographics, medical history, presenting symptoms, EFB type, surgical findings, and hospital visit charges/costs., Results: 203 patients were included. 178 of 203 (87.7%) patients were admitted prior to operation. Unwitnessed EFB ingestion (p < 0.001, OR = 15.1, 95% CI = 5.88-38.6), experiencing symptoms for longer than a week (p < 0.001, OR = 11.4, 95% CI = 3.66-38.6) and the following presenting symptoms increased the odds of esophageal injury: dysphagia (p = 0.04, OR = 2.45, 95% CI = 1.02-5.85), respiratory distress (p = 0.005, OR = 15.5, 95% CI = 2.09-181), coughing (p < 0.001, OR = 10.1, 95% CI = 3.73-28.2), decreased oral intake (p = 0.001, OR = 6.60, 95% CI = 2.49-17.7), fever (p = 0.001, OR = 5.52, 95% CI = 1.46-19.6), and congestion (p = 0.001, OR = 8.15, 95% CI = 2.42-27.3). None of the 51 asymptomatic patients had esophageal injury. The median total charges during the encounter was $20,808 (interquartile range: $18,636-$24,252), with operating room (OR) (median: $5,396; 28.2%) and inpatient admission (median: $5,520; 26.0%) contributing the greatest percentage., Conclusions: Asymptomatic patients with EFBs did not experience esophageal injury. The OR and inpatient observation accounted for the greatest percentage of the hospital charges. These results support developing a potential algorithm to triage asymptomatic patients to be managed on a same-day outpatient basis to improve the value of care., Level of Evidence: 3 Laryngoscope, 134:4774-4782, 2024., (© 2024 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)

Objective: Investigate associations between socioeconomic indicators of healthcare access with family compliance with cleft-related otologic and audiologic care within an interdisciplinary model., Design: Retrospective case series., Subjects and Setting: Children born 2005-2015 who presented to the Cleft-Craniofacial Clinic (CCC) at a quaternary care children's hospital., Interventions: Associations between main outcome measures and Area Deprivation Index (ADI), median household income for zip code, distance from hospital, and insurance status were evaluated., Main Outcome Measures: Cleft types, ages at presentation to outpatient clinic (cleft, otolaryngology, and audiology), and ages at procedures (first tympanostomy tube insertion (TTI), lip repair, and palatoplasty) were measured., Results: Most patients were male (147/230, 64%) with cleft lip and palate (157/230, 68%). Median age at first cleft, otolaryngology, and audiology visits were 7 days, 86 days, and 5.9 months, respectively. Private insurance predicted lower no-show rates (p = .04). Age at first CCC visit was younger for patients with private insurance (p = .04) and older for those who lived further from the hospital (p = .002). Age at lip repair was positively correlated with national ADI (p = .03). However, no socioeconomic status (SES) proxy or proximity to hospital was associated with delays in first otolaryngology or audiology examination or TTI., Conclusion: Once children become established within an interdisciplinary CCC, SES appears to bear little influence on cleft-related otologic and audiologic care. Future efforts should aim to elucidate which aspects of the interdisciplinary model maximize multisystem cleft care coordination and increase access for higher risk populations., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Importance: Major surgery sometimes involves long recovery or even permanent institutionalization. Little is known about long-term trajectories of postoperative recovery, as surgical registries are limited to 30-day outcomes and care can occur across various institutions., Objective: To characterize long-term postoperative recovery trajectories., Design, Setting, and Participants: This retrospective cohort study used Veterans Affairs (VA) Surgical Quality Improvement Program data (2016 through 2019) linked to the Residential History File, combining data from the VA, Medicare/Medicaid, and other sources to capture most health care utilization by days. Patients were divided into younger (younger than 65 years) or older (65 years or older) subgroups, as Medicare eligibility is age dependent. Latent-class, group-based trajectory models were developed for each group. These data were analyzed from February 2023 through August 2024., Exposure: Surgical care in VA hospitals., Main Outcomes and Measures: Days elsewhere than home (DEH) were counted in 30-day periods for 275 days presurgery and 365 days postsurgery., Results: A 5-trajectory solution was optimal and visually similar for both age groups (cases: 179 879 younger [mean age (SD) 51.2 (10.8) years; most were male [154 542 (83.0%)] and 198 803 older [mean (SD) age, 72.2 (6.0) years; 187 996 were male (97.6%)]). Most cases were in trajectories 1 and 2 (T1 and T2). T1 cases returned home within 30 days (younger, 74.0%; older, 54.2%), while T2 described delayed recovery within 30 to 60 days (younger, 21.6%; older, 35.5%). Trajectory 3 (T3) and trajectory 4 (T4) were similar for the first 30 days postsurgery, but subsequently separated with T3 representing protracted recovery of 6 months or longer (younger, 2.7%; older, 3.8%) and T4 indicating long-term loss of independence (younger, 1.3%; older, 5.2%). Few (trajectory 5) were chronically dependent, with 20 to 30 DEH per month before and after surgery (younger, 0.4%; older, 1.3%)., Conclusions and Relevance: In this study, trajectory models demonstrated clinically meaningful differences in postoperative recovery that should inform surgical decision-making. Registries should include longer-term outcomes to enable future research to distinguish patients prone to long-term loss of independence vs protracted, but meaningful recovery.

Introduction: Subperiosteal orbital abscesses (SPOA) are the most common suppurative complications of acute bacterial sinusitis. Medial SPOAs arise from infection of the ipsilateral ethmoid sinus and favor initial conservative management reserving surgical drainage for patients who do not demonstrate clinical improvement. No standard algorithm defining medical versus surgical treatment of medial SPOAs exist in the pediatric population., Objectives: To identify a size cutoff for medial SPOAs to predict the likelihood for surgical drainage., Methods: This is a retrospective review of patients with medial SPOAs at a tertiary care center from 2003 to 2017. Diagnosis of SPOA was based on radiographic findings. Variables included are patient demographics, antibiotic therapy, surgical intervention, and length of stay., Results: 82 patients with a medial SPOA were included with an average age at presentation of 6.27 (range 0-15) years were included in this study. 62 patients were male (75.6 %), and 20 were female (24.4 %). The average abscess length was 16.1 mm, range 4.5-30.7 mm. The average abscess width was 4.17 mm, range 1.5-14.6 mm. The odds ratio for surgical treatment with every 1 mm increase in abscess width was 1.89 (95CI:1.33-2.69, p < 0.001). Abscesses over 3.6 mm width were 6.65 times more likely to undergo surgical drainage than those less than 3.6 mm (OR:6.65, 95CI:2.52-17.54, p < 0.001). The average(SD) length of stay was 5.4(3.0) days for patients who underwent surgery and 4.0(0.9) days for patients treated with conservative measures, p < 0.001., Conclusion: Medial SPOAs greater than 3.6 mm were more likely to undergo surgical drainage; however there was no difference in the likelihood of drainage between anteriorly and posteriorly based medial abscesses. These findings help further characterize the landscape of pediatric subperiosteal abscesses that are managed with surgical drainage., Competing Interests: Declaration of competing interest There are no conflicts of interest to report for any author., (Copyright © 2024. Published by Elsevier B.V.)

Introduction: Botox is frequently used for sialorrhea in patients with compromised airways and those with etiologies causing difficulty with secretion management (i.e. strokes, neurologic disorders, etc.). There are no published studies regarding the use of botulinum toxin (BoNT) in the neonate population. We aim to discuss our experience and safety of BoNT use in the neonate population in regards to alleviating secretion management and airway protection., Methods: Retrospective review of neonates admitted to the neonatal intensive care unit (NICU) ≤12 months of age who received BoNT injection to submandibular (SMG) and parotid (PG) glands for sialorrhea/dysphagia. BoNT was administered under ultrasound (u/s) guidance by interventional radiology., Results: 6 children were examined. 2 (33 %) were male. Avg NICU stay was 87.5 ± 33.1 days. 2 underwent surgical airway intervention prior to injection. Mean age at initial BoNT was 1.5 ± 0.7 months. Avg weight at injection was 4 ± 1.1 kg. Each PG and SMG were injected in 5/6 cases. Bilateral SMG were unidentified on u/s in 1 case and thus not injected. Dose range injected per gland was 5-15u. 100 % required tube feeds, 50 % with tubes distal to stomach (NJT/NDT). 83 % were completely NPO prior to injection and there was no noted clinical improvement in oral skills post injection. All had noted desats/apneas prior to injection and 83 % had reported decreased events post injection. 50 % had reported decrease O2 requirements and frequent suctioning 2wks after injection, however 2 (33 %) required surgical airway intervention after injection (trach, SGP/MDO). 4/6 (67 %) trialed medical therapy, anticholinergics being the most common. 50 % underwent 2nd injection (age = 6.5 ± 0.3 months) avg. 4.7 ± 0.7mo after 1st injection, and the same 3pts underwent 3rd injection (age = 12.5 ± 2.4 months) avg. 6.1 ± 2.5mo after 2nd injection. 1 pt. had a total 6 injections. There were no injection related complications., Conclusion: BoNT injection is a safe, non-invasive alterative for management of sialorrhea in neonates. Further extensive study needs to be performed to identify the optimal dose per gland in this population., Competing Interests: Declaration of competing interest The authors have no conflicts of interest or financial disclosures., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Geographic information systems (GIS) provide a unique set of tools to spatially analyze health care and identify patterns of health outcomes to help optimize delivery. Our goal is to create maps of pediatric tracheostomy patients using GIS to assess socioeconomic and other factors that impact postoperative care after discharge to home., Methods: A retrospective study was performed on patients (≤21 years old) who underwent tracheostomy at a tertiary care pediatric hospital from January 1, 2015 to December 31, 2020. Using GIS, we geocoded patient addresses and conducted spatial analyses of the relationship between patients and access to health care providers as well as vulnerable population factors including poverty, educational attainment, and single-parent households., Results: A total of 156 patients were included. Patients initially discharged to transitional care (108/156, 69.2%) had significantly higher likelihood of presenting to the ED regardless of socioeconomic status (OR: 2.28, 95% CI: 1.03-5.05; p = 0.042). There was no relationship between ED visit rate and median household income, poverty level, and percentage of uneducated adults (p = 0.490; p = 0.424; p = 0.752). Median distance to the tertiary care pediatric hospital was significantly longer for patients with no ED visit (median = 61.28 miles; SD = 50.90) compared with those with an ED visit (median = 37.75 miles; SD = 35.92) (p = 0.002)., Conclusion: The application of GIS could provide geo-localized data to better understand the healthcare barriers to access for children with tracheostomies. This study uniquely integrates medical record data with socioeconomic factors and social determinants of health., Level of Evidence: 4 Laryngoscope, 134:1919-1925, 2024., (© 2023 The American Laryngological, Rhinological and Otological Society, Inc.)

Objective: To evaluate the associations between proxy measures of socioeconomic status (SES) and usage of cochlear implants., Study Design: Retrospective case series., Methods: Usage outcomes were measured among patients with a cochlear implant and data logging at a tertiary care children's hospital between 2002 and 2017. Time per day with cochlear implant turned on, coil off, and listening to speech in noise and speech in quiet were extracted from audiology records, averaging right and left ear usage for those with bilateral implants. Associations between cochlear implant usage and demographic factors such as insurance type and median household income for zip code were assessed., Results: There were 142 total patients; 74 had bilateral usage data. Mean on air time was 10.76 hours (SD: 4.4). Those with private insurance had 1.2 hour more on air time/day ( P  = .047) and 0.9 hour more quiet time/day ( P  = .011) compared to those with public insurance. Younger age at last visit was associated with increased speech in quiet ( B  = -.08; 95% CI: -0.12-[-0.05], P  < .001) and coil off ( B  = -0.06; 95% CI: -0.11-[-0.02], P  = .006). Younger age at implant was associated with longer duration since last data logging visit ( B  = -10.46; 95% CI: -18.41-[-2.51], P  = .010), more daily use (on air; B  = -0.23; 95% CI: -0.43-[-0.03], P  = .026), and increased time spent listening to speech in noise ( B  = -0.07; 95% CI: -0.14-[-0.01], P  = .024). No other significant associations between datalogging output and each proxy SES factor were found., Conclusions: Lack of private insurance and older age at implantation decreased access to binaural hearing for children and young adults with cochlear implants., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: To determine whether a 6- or 12-month look-back period affected rates of reported social risks in a social risk survey for use in the Veterans Health Administration and to assess associations of social risks with overall health and mental health., Study Design: Cross-sectional survey of respondents randomized to 6- or 12-month look-back period., Data Sources and Study Setting: Online survey with a convenience sample of Veterans in June and July 2021., Data Collection/extraction Methods: Veteran volunteers were recruited by email to complete a survey assessing social risks, including financial strain, adult caregiving, childcare, food insecurity, housing, transportation, internet access, loneliness/isolation, stress, discrimination, and legal issues. Outcomes included self-reported overall health and mental health. Chi-squared tests compared the prevalence of reported social risks between 6- and 12-month look-back periods. Spearman correlations assessed associations among social risks. Bivariate and multivariable logistic regression models estimated associations between social risks and fair/poor overall and mental health., Principal Findings: Of 3418 Veterans contacted, 1063 (31.10%) responded (87.11% male; 85.61% non-Hispanic White; median age = 70, interquartile range [IQR] = 61-74). Prevalence of most reported social risks did not significantly differ by look-back period. Most social risks were weakly intercorrelated (median |r| = 0.24, IQR = 0.16-0.31). Except for legal issues, all social risks were associated with higher odds of fair/poor overall health and mental health in bivariate models. In models containing all significant social risks from bivariate models, adult caregiving and stress remained significant predictors of overall health; food insecurity, housing, loneliness/isolation, and stress remained significant for mental health., Conclusions: Six- and 12-month look-back periods yielded similar rates of reported social risks. Although most individual social risks are associated with fair/poor overall and mental health, when examined together, only adult caregiving, stress, loneliness/isolation, food, and housing remain significant., (Published 2023. This article is a U.S. Government work and is in the public domain in the USA. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)

Background: First health care professionals arriving at the bedside in tracheostomy-related emergencies are rarely the surgical subspecialists who placed the tracheostomy and are unfamiliar with the relevant anatomy and tracheostomy specifications for the individual patient. We hypothesized that implementing a bedside airway safety placard would increase caregiver confidence, understanding of airway anatomy, and management of patients with a tracheostomy., Methods: A prospective survey study was performed by distributing a tracheostomy airway safety survey before and after implementation of an airway safety placard in a 6-month study period. Placards emphasizing critical airway anomalies as well as emergency management algorithm suggestions designed by the otolaryngology team at the time of tracheostomy were placed at the head of the bed and traveled with the patient during transport around the hospital., Results: Of 377 staff members requested to complete the surveys, 165 (43.8%) responses were obtained, and 31 (8.2% [95% CI 5.7-11.5]) paired pre- and post-implementation responses were recorded. Differences were found in the paired responses, including increases in the domains of confidence ( P = .009) and experience ( P = .01) post implementation. Less experienced providers (≤ 5 y of experience) ( P = .005) and providers from neonatology ( P = .049) demonstrated improved confidence post implementation, which was not observed in their more experienced (> 5 y) or respiratory therapy counterparts., Conclusions: Given the limitations of a low survey response rate, our findings suggest that an educational airway safety placard initiative can be a simple, feasible, and low-cost quality improvement tool to enhance airway safety and possibly decrease potentially life-threating complications among pediatric patients with a tracheostomy. The implementation of the tracheostomy airway safety survey at our single institution warrants a larger multi-center study and validation of the survey., Competing Interests: The authors have disclosed no conflicts of interest., (Copyright © 2023 by Daedalus Enterprises.)

Objective: Puberty has been shown to accelerate growth of vascular malformations, including lymphatic (LM) and venous malformations (VM). This study aims to compare the number of procedures performed before and after puberty in patients with LM and VM to assess whether the onset of puberty results in higher treatment frequency., Methods: A retrospective review of head and neck LM and VM patients who were evaluated between January 2009 and December 2019 was performed. Patient demographics, lesion characteristics, and procedural details were recorded. For the purposes of this study, 11 years or older in females and 12 years or older in males were the established cut-offs for the onset of puberty., Results: After initial screening of 357 patients, 83 patients were included in the study based on inclusion criteria. There were 34 patients with LM (41 %) and 49 with VM (59 %). The mean age at diagnosis was 6.1 ± 10.9 years (LM: 4.2 ± 7.0, VM: 7.4 ± 12.9, p = 0.489). 68 patients underwent treatments, which included sclerotherapy, surgical excision, and/or laser. For all patients, the average number of lifetime treatments when initiated before puberty was 3.78 ± 2.81 and when initiated after puberty was 2.17 ± 1.37 (p = 0.022). Patients diagnosed pre-puberty were more likely to undergo treatments vs. those diagnosed after puberty (OR 10.00, 95 % CI: 2.61-38.28, p < 0.001)., Conclusion: We found that the number of treatments was fewer in those who started treatment after puberty. This finding suggests that providers may elect to proceed with observation in asymptomatic patients, given that waiting until after the onset of puberty has not shown an increase in the procedural load on patients., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To examine the prevalence and nature of nasal endoscopic findings in patients referred for structural nasal obstruction, and analyze how such findings influence the preoperative evaluation or operative plan., Study Design: Cross-sectional study., Setting: University-based academic otolaryngology practice., Methods: Nasal endoscopy was performed by a single surgeon and the exam findings were documented. Patient demographics, variables in the patient history, Nasal Obstruction Symptom Evaluation scores, and an Ease-of-Breathing Likert Scale were tested for associations with findings on endoscopy., Results: A total of 82 of 346 patients (23.7%) had findings on rigid nasal endoscopy not appreciable on anterior rhinoscopy. Prior nasal surgery (p = .001) and positive allergy testing (p = .013) were significantly associated with findings on nasal endoscopy. Endoscopic findings prompted additional preoperative studies in 50 (14.5%) patients, and a change in the operative plan in 26 (7.5%) patients., Conclusion: In patients referred for surgical management of nasal obstruction, findings on nasal endoscopy otherwise undetected with anterior rhinoscopy are most common in but certainly not limited to those with prior nasal surgery or allergic rhinitis. Routine nasal endoscopy should be considered for all patients being evaluated for nasal airway surgery. These results may benefit future updates of the clinical consensus statements regarding the role of nasal endoscopy in the evaluation of nasal valve compromise and septoplasty., (© 2023 American Academy of Otolaryngology-Head and Neck Surgery Foundation.)

Introduction  Despite several pediatric tracheostomy decannulation protocols there remains tremendous variability in practice. The effect of tracheostomy capping on decannulation has been studied but the role of speaking valves (SVs) is unknown. Objective  Given the positive benefits SVs have on rehabilitation, we hypothesized that SVs would decrease time to tracheostomy decannulation. The purpose of the present study was to evaluate this in a subset of patients with chronic lung disease of prematurity (CLD). Methods  A retrospective chart review was performed at a tertiary care children's hospital. A total of 105 patients with tracheostomies and CLD were identified. Data collected included demographics, gestational age, congenital cardiac disease, airway surgeries, granulation tissue excisions, SV and capping trials, tracheitis episodes, and clinic visits. Statistics were performed with logistic and linear regression. Results  A total of 75 patients were included. The mean gestational age was 27 weeks (standard deviation [SD] = 3.6) and the average birthweight was 1.1 kg (SD = 0.6). The average age at tracheostomy was 122 days (SD = 63). A total of 70.7% of the patients underwent decannulation and the mean time to decannulation (TTD) was 37 months (SD = 19). A total of 77.3% of the patients had SVs. Those with an SV had a longer TTD compared to those without (52 versus 35 months; p  = 0.008). Decannulation was increased by 2 months for every increase in the number of hospital presentations for tracheitis ( p  = 0.011). Conclusion  The present study is the first, to our knowledge, to assess the effect of SVs on tracheostomy decannulation in patients with CLD showing a longer TTD when SVs are used., Competing Interests: Conflict of Interests The authors have no conflict of interests to declare., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit ( https://creativecommons.org/licenses/by/4.0/ ).)

Objective: To report key characteristics and patterns of captive insurance claims not publicly reported in otolaryngology across a large tertiary-level academic health system over the previous 2 decades., Study Design: Case series., Setting: The tertiary care health system., Methods: The internal captive insurance database at a tertiary level healthcare system was queried to identify otolaryngology-related malpractice claims regardless of final disposition (settled or dismissed) filed from 2000 to 2020. The date of the incident, date of claim, error type, patient outcome, provider subspecialty, total expenses, disposition, and final reward amount were recorded., Results: Twenty-eight claims were identified. There were 11 (39.3%) claims from 2000 to 2010 and 17 (60.7%) claims from 2011 to 2020. Head and neck surgery was the most frequently implicated subspecialty (n = 9, 32.1% of all cases), followed by general otolaryngology (n = 7, 25.0%), pediatrics (n = 5, 17.9%), skull base/rhinology (n = 4, 14.3%), and laryngology (n = 1, 3.6%). Improper surgical performance was cited in 35.7% of cases (n = 10), followed by failure to diagnose (n = 8, 28.6%), to treat (n = 4, 14.3%), and to obtain informed consent (n = 3, 10.7%). While 2 cases are ongoing, a total of 17/26 (65.4%) cases were settled and 20/26 (76.9%) dismissed some or all parties. Dismissed claims had significantly higher expenses (p = .022) and duration from incident to disposition (p = .013) compared to settled claims., Conclusion: This study expands the malpractice landscape in otolaryngology by including data not readily available through public sources and compares it to national trends. These findings encourage otolaryngologists to better gauge current quality and safety measures that best protect patients from harm., (© 2023 American Academy of Otolaryngology-Head and Neck Surgery Foundation.)

Purpose: A novel "Modified TCA Alloderm™ Myringoplasty" (TCA myringoplasty) technique for reconstruction of uncomplicated chronic tympanic membrane (TM) perforations is described., Materials and Methods: Descriptive surgical technique for TCA myringoplasty on 12 total patients from 1/1/2020 to 12/31/2020. 3 patients were excluded for incomplete records. Statistical analysis employed Wilcoxon signed-rank tests. Both structural (pre/post visual inspection and tympanogram) and functional (pre/post pure tone average, PTA) outcome measures are reported., Results: 12 total ears were analyzed from 9 patients. Average age at surgery was 6 (range 3-22). Perforation size ranged from 10 to 60 %. Rate of structural success was 100 %. Functionally, postoperative PTA were significantly decreased from preoperative (mdn(range) = 18.44(13.13-24.38) vs mdn(range) = 11.25(6.25-22.50), p = .008). Only one TM required >1 procedure to achieve closure., Conclusions: Chronic TM perforations are typically reconstructed via Type I tympanoplasties with temporalis fascia, reserving myringoplasty for favorable perforations (<25 % in size and posterior). Our novel TCA myringoplasty technique has excellent outcomes independent of size and location. We apply a chemical peel concept to a modified myringoplasty technique, obviating incisions and graft harvest. Advantages of Alloderm™ include: 1) a more rigid graft, facilitating manipulation and precise placement; 2) various size and thickness options, especially useful for dimeric tympanic membranes, tympanolysis of adhesions, and bilateral perforations; 3) no donor morbidity and harvest time; 4) autologous tissue preservation. The sole disadvantage of cost is mitigated by reduced operative time and complication management. This study revealed encouraging proof-of-concept preliminary data warranting prospective and sufficiently powered analysis, supporting the technique as a viable alternative to the gold standard., Competing Interests: Declaration of competing interest None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Evaluate health-related quality of life (HR-QOL) benefits with cochlear implantation (CI) in children with unilateral sensorineural hearing loss (USNHL) versus bilateral sensorineural hearing loss (BSNHL)., Study Design: A cross-sectional survey of parents of children who underwent CI for USNHL and BSNHL., Setting: Tertiary care academic centers., Methods: The "Children with cochlear implants: parental perspectives" survey was administered. Parents rated responses on a 5-point Likert scale. Scores greater than 3.0 were considered favorable. Responses were recorded within 8 domains and groups were compared with respect to domain scores. Analysis of covariance models was used to compare groups while adjusting for age at implantation and duration of implant use., Results: There were 31 patients with USNHL and 27 patients with BSNHL. The average age of implantation in BSNHL patients was 1.9 and 6.7 years for USNHL. Parents of all children answered favorably in all domains. When adjusted for age at implantation and duration of implant use, parents of BSNHL children responded significantly more favorably only in 2 domains. When comparing patients with older age or prolonged duration of hearing loss in the USNHL cohort, there were favorable responses in all domains with no significant differences between groups., Conclusion: There are HR-QOL benefits of CI in USNHL children; less pronounced favorable results were noted only in 2 domains when compared to BSNHL children. Benefits were noted with CI in USNHL children at an older age at implantation or prolonged duration of hearing loss. Therefore, these factors should not be absolute contraindications for CI in USNHL., (© 2023 The Authors. Otolaryngology-Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology-Head and Neck Surgery Foundation.)

Objective: PHACE is a rare syndrome that can present with airway hemangiomas. Management for these patients is variable and the utilization of operative endoscopic airway evaluation has not been described. The objectives of this study were to identify the incidence of airway symptoms in patients being evaluated for PHACE syndrome and determine the utility of operative endoscopy., Methods: An IRB-approved retrospective cohort study was conducted on consecutive pediatric patients with head and neck infantile hemangioma (IH) evaluated in a multi-disciplinary vascular anomalies center between 2013 and 2019. Patients were included if they were being worked up for PHACE syndrome and had an otolaryngology evaluation. Demographics, clinical, and surgical variables were collected., Results: There were 317 patients with head and neck IH. Thirty-six patients met inclusion criteria. The majority of patients were female (31/36; 86.1%) and less than half of the patients (15/36; 41.7%) were eventually diagnosed with PHACE syndrome. Median age at presentation was 2 months (range 0-82 months). A total of 28/36 (77.8%) of patients were managed with propranolol. The majority of the patients presented without aerodigestive symptoms; however, 16/36 (44.4%) of patients presented with symptoms such as stridor, hoarseness, and dysphagia. A total of 20/36 (55.6%) of patients underwent operative endoscopy. A total of 8/20 (40.0%) of patients who underwent operative endoscopy had operative intervention. Of the entire cohort, only 2/15 (13.3%) patients diagnosed with PHACE were found to have a subglottic hemangioma. Both patients presented with stridor., Conclusion: Operative endoscopy remains useful in the workup of PHACE syndrome to identify subglottic hemangiomas, however there may be relatively low yield in asymptomatic patients. In office flexible laryngoscopy may be a less invasive means to examine the subglottic region. A multi-center prospective study would be necessary to evaluate incidence of subglottic hemangiomas in asymptomatic patients evaluated for PHACE.

Introduction  For multiple reasons, elective pediatric otolaryngology surgical procedures have declined during the COVID-19 pandemic. Objective  The purpose of the present study was to assess whether the prevalence of pediatric neck abscesses managed with operative drainage decreased compared with previous years. Methods  Medical records of all pediatric cases at a tertiary care children's hospital diagnosed with abscess of the neck and treated with incision and drainage were evaluated between the dates of April 1 and November 30 from 2015 to 2020. Outcomes were compared for each year from 2015 to 2019 to 2020, which included location, abscess size, duration of antibiotic treatment, microbiology, and the number of cases per year. Results  A total of 201 cases were included. The mean ± standard deviation (SD) presenting age in the 2015 to 2019 group was 5.05 ± 5.03 years old and 2.24 ± 1.91 years old in the 2020 group. The mean number of cases between 2015 and 2019 was 35.6 ± 4.2, whereas the number of cases in 2020 was 23 ( p  = 0.002). Of those patients who underwent IV antibiotic therapy prior to presentation ( n  = 43), the mean number of days before admission was 1.98 ± 2.95 ( n  = 40) from 2015 to 2019 and 12.00 ± 10.39 ( n  = 3) in 2020 ( p  = 0.008). The percent of cases with multiple strains cultured between 2015 and 2019 was 13.4% versus 18.2% in 2020 ( p  = 0.007). Conclusion  There was a decrease in the number of operative neck abscesses in 2020 compared with the mean number per year from 2015 to 2019. COVID-19 mitigation strategies leading to reduced transmission of other viral and bacterial illnesses and a tendency toward prolonged medical management to avoid surgery are two possible explanations., Competing Interests: Conflict of Interests The authors have no conflict of interests to declare., (Fundação Otorrinolaringologia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ).)

Objectives: To compare the mean pre-operative air-bone gaps (ABG), mean post-operative ABGs, and extrusion rates between pediatric recipients of partial ossicular reconstruction prostheses (PORPs) and pediatric recipients of total ossicular reconstruction prostheses (TORPs) via a systematic review and meta-analysis., Methods: A quantitative systematic review last updated on September 29, 2021 of PubMed, Scopus, and Embase databases was conducted for studies reporting mean post-operative ABGs or numbers of children with post-operative ABG ≤ 20 dB following PORP and TORP procedures in at least five children aged 0-18 years. Studies were excluded if they were review articles, conference abstracts, or not in English. Studies that primarily reported data on congenital aural atresia, stapedectomy/stapedotomy, congenital stapes fixation, or juvenile otosclerosis were also excluded. NIH Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies was used to assess for risk of bias. Review Manager (RevMan) version 5.4.1 was used to perform the meta-analysis and generate forest plots., Results: Out of 648 unique abstracts retrieved, 11 papers were included in this systematic review with meta-analysis. Data from 449 children (247 TORP recipients and 202 TORP recipients) are represented among the various analyses. Data from nine studies, representing 84.2 % of all children in the systematic review, demonstrated that PORP recipients presented with a pre-operative ABG 6.30 dB less than TORP recipients (mean difference: -6.30, 95 %CI: -7.4, -5.18, p < 0.01). Data from these same children demonstrated that PORP recipients had a 1.80 dB less post-operative ABG compared to TORP recipients (mean difference: -1.80 dB, 95 %CI: -2.84, -0.77, p < 0.001). Data from seven studies, representing 49.4 % of all children in the systematic review, demonstrated that PORP recipients were more likely to have a successful closure of the post-operative ABG to ≤20 dB (OR: 2.12, 95 %CI: 1.18, 3.79, p = 0.01). In these same children, 62.5 % of PORP recipients had a post-operative ABG ≤ 20 dB and 48.3 % of TORP recipients had a post-operative ABG ≤ 20 dB. There was no difference in extrusion rates between PORP recipients compared to TORP recipients (OR: 1.08, 95 %CI: 0.31, 3.78, p = 0.90) from five studies representing 45.9 % children in the systematic review., Conclusion: Children who receive a PORP have better pre-operative hearing baselines and post-operative hearing outcomes compared to those who receive TORP with similar rates of extrusion. More pediatric studies should report their mean pre- and post-operative ABGs stratifying by various material types, surgical indications, and surgical details to facilitate future meta-analyses., Competing Interests: Declaration of competing interest There are no conflicts of interest to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: Bilateral myringotomy with tube insertion (BMT) is a common procedure performed in children. Appropriate follow-up is necessary to ensure management of postoperative sequalae. The objectives are to investigate (1) the relationship between insurance type and postoperative follow-up attendance and (2) the effect of follow-up on need for further care after BMT., Study Design: Retrospective cohort study., Setting: The study included patients <3 years of age undergoing BMT for recurrent acute otitis media at a tertiary care children's hospital within a single year and followed for 3 years. Patients were excluded if they had received a prior BMT; underwent a concurrent otolaryngologic procedure; or had a syndromic diagnosis, craniofacial abnormality, or any significant cardiac or respiratory comorbidity., Methods: Number of follow-up appointments, demographics, socioeconomic status, and postoperative outcomes were analyzed., Results: A total of 734 patients were included with mean (SD) age of 1.4 years (0.50). The majority of patients had private insurance (520/734, 70.8%). Patients with public insurance attended fewer postoperative appointments (1.5 vs 1.8, P < .001) and had a higher incidence of BMT-related emergency department (ED) visits (10.3% vs 3.8%, P = .001). There was no significance found when different insurance providers were compared. An adjusted multivariate regression analysis showed that patients with private insurance were more likely to attend postoperative appointments (odds ratio, 3.52 [95% CI, 2.12-5.82]; P < .001) and less likely to have a BMT-related ED visit (odds ratio, 0.42 [95% CI, 0.20-0.89]; P = .024)., Conclusion: Insurance type is related to outcomes after the treatment of recurrent acute otitis media with BMT. Future studies that survey individuals will help identify barriers that contribute to patient absence at follow-ups and need for subsequent ED visits.

Calcium (Ca 2+ ) is well known as a second messenger in eukaryotes, where Ca 2+ signaling controls life-sustaining cellular processes. Although bacteria produce the components required for Ca 2+ signaling, little is known about the mechanisms of bacterial Ca 2+ signaling. Previously, we have identified a putative Ca 2+ -binding protein EfhP (PA4107) with two canonical EF-hand motifs and reported that EfhP mediates Ca 2+ regulation of virulence factors production and infectivity in Pseudomonas aeruginosa, a human pathogen causing life-threatening infections. Here, we show that EfhP selectively binds Ca 2+ with 13.7 µM affinity, and that mutations at the +X and -Z positions within each or both EF-hand motifs abolished Ca 2+ binding. We also show that the hydrophobicity of EfhP increased in a Ca 2+ -dependent manner, however no such response was detected in the mutated proteins. 15  N-NMR showed Ca 2+ -dependent chemical shifts in EfhP confirming Ca 2+ -binding triggered structural rearrangements in the protein. Deletion of efhP impaired P. aeruginosa survival in macrophages and virulence in vivo. Disabling EfhP Ca 2+ binding abolished Ca 2+ induction of pyocyanin production in vitro. These data confirm that EfhP selectively binds Ca 2+ , which triggers its structural changes required for the Ca 2+ regulation of P. aeruginosa virulence, thus establishing the role of EfhP as a Ca 2+ sensor., (© 2022. The Author(s).)

Objective: Up to 50% of pediatric patients have a persistent tracheocutaneous fistula (TCF) after tracheostomy decannulation. Classically these fistula tracts were excised and completely closed in a multilayered fashion, but recently closure by secondary intention has become the standard of care. However, variations in postoperative care still exist. The primary objectives of this study were to compare outcomes between patients who had a primary closure versus closure by secondary intention after excision of a TCF in children with a tracheostomy placement at one year old or less and to determine if closure by secondary intention will be equally efficacious compared to traditional primary closure., Methods: Patients ages 0-21 years who had a primary or secondary closure of a TCF at a tertiary care children's hospital following decannulation of a tracheostomy tube were reviewed and those with a tracheostomy placement ≤1 year old were included. Demographic information, comorbidities, and surgical information were extracted from inpatient and outpatient charts. Mann-Whitney U test, Fisher's Exact test, and logistic regression to compare outcomes across the two TCF surgical groups., Results: A total of 64 patients met inclusion with primary closures in 25 (39.1%) patients and secondary closures in 39(60.9%) patients. Patients who underwent secondary closure had a significantly shorter surgery duration (p < .001), shorter ICU length of stay (p < .001), and shorter postop LOS (p < .001). There were no differences in cardiac complications, respiratory complications, and the need for additional closure surgery between the two techniques, p > .05. Time from decannulation to TCF in months increased with primary closure, p = .010., Conclusion: Closure of tracheocutaneous fistula by secondary intention is safe and effective and can allow for shorter hospital stays in children with a tracheostomy placement at a year old or less., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Post-tracheotomy swallowing function has not been well described in the pediatric population. This study aims to (1) determine differences in swallowing functioning pre- and post-tracheotomy and (2) examine the association between postoperative dysphagia and indication for tracheotomy, age at the time of tracheotomy, and time between tracheotomy and modified barium swallow (MBS)., Methods: A retrospective chart review was performed on 752 patients who underwent a tracheotomy from 2003 to 2018 and had adequate documentation for review. Patients were included if they received a post-operative MBS. Descriptive statistics, logistic regression, and Fisher's exact test were used to analyze the data., Results: The cohort included 233 patients. The mean age at the time of tracheotomy was 25 months (±50.5). The indications for the tracheotomy were upper airway obstruction (110/233, 47.2%), chronic respiratory failure (104/233, 44.6%), and neurologic disease (19/233, 8.2%). The mean time from tracheotomy to post-operative MBS was 224 days (±297.7). Of the patients who had documented pre- and post-tracheotomy diets, nearly half of patients had improvement in their swallowing function after tracheotomy placement (82/195; 42.1%). Post-tracheotomy MBS recommended thickened liquids in 30.9% of the patients (72/233) and 42.5% (99/233) were recommended thin liquids. The remainder (62/233, 26.6%) remained nothing by mouth (NPO). Patients with neurological disease as the indication for the tracheotomy were more likely to remain NPO ( P  = .039)., Conclusion: A tracheotomy can functionally and anatomically affect swallowing in pediatric patients. The majority of our studied cohort was able to resume some form of an oral diet postoperatively based on MBS. This study highlights the need for objective measurements of swallowing in the postoperative tracheotomy patient to allow for safe and timely commencement of an oral diet., Level of Evidence: Level 3.

Objective: Evidence supporting the use of acid suppression therapy (AST) for laryngomalacia (LM) is limited. The objective of this study was to determine if outpatient-initiated AST for LM was associated with symptom improvement, weight gain, and/or avoidance of surgery., Methods: A retrospective cohort was reviewed at a tertiary-care children's hospital. Patients were included if they were diagnosed with LM at ≤6 months of age, seen in an outpatient otolaryngology clinic between 2012 and 2018, and started on AST. Primary outcomes were improvement of airway and dysphagia symptoms, weight gain, and need for surgery. Severity was assessed by symptom severity., Results: Of 2693 patients reviewed, 199 met inclusion criteria. Median age of diagnosis was 4 weeks (range: 0-29 weeks). LM was classified as mild/moderate (71.4%) and severe (28.6%) based on symptom severity. Severity on flexible fiberoptic laryngoscopy (FFL) was not associated with clinical severity. Weight percentile, airway symptoms, and dysphagia symptoms improved within the cohort. In total, 26.1% underwent supraglottoplasty (SGP). In multivariate analysis, only severe LM on FFL was predictive of SGP (OR: 7.28, 95%CI: 1.91-27.67, p = .004)., Conclusion: Clinical symptom severity did not predict response to AST raising the question of utility of AST in LM. Severity of LM based on FFL, not clinical severity, was associated with decision to pursue SGP. Prospective randomized trials are needed to better understand the role of AST in LM., Level of Evidence: Level 3., (Copyright © 2022. Published by Elsevier Inc.)

Introduction: The coronavirus disease of 2019 (COVID-19) pandemic catalyzed an unprecedented redesign and innovative overhaul of health care delivery thrusting from fringe to mainstream virtual care. With a return to conventional practice, we now must create a research and policy agenda using the changes wrought by COVID-19 to help create a better health care system in its aftermath. The purpose of this study was to assess satisfaction of otolaryngology outpatient visits during the pandemic., Methods: A prospective survey study was performed on caregivers of all patients ages 0-26 years old seen in the Division of Pediatric Otolaryngology at our large tertiary care children's hospital from February-April 2020. The three study groups were those seen in-person 6 weeks before telemedicine was implemented (IBTM), those seen in telemedicine during the first 6 weeks (TM) it was implemented at our hospital, and those seen in-person during the telemedicine period (IDTM) in the same timeframe. The survey consisted of satisfaction questions related to their visit, if their child was recommended surgery at the time of the visit, and if the caregiver agreed with the recommendation. A medical record review was also performed., Results: A total of 176 caregivers completed the survey with 113(64.2%) completing the survey for an IBTM appointment, 59(33.5%) for a TM appointment, and 4(2.3%) for an IDTM appointment. There were 100(56.8%) male patients and 167(94.9%) were white. Families gave a higher response for the statement "The ability to communicate with the physician" (p = .012) and "The overall outpatient experience" (p = .004) in the IBTM cohort compared to the TM group. There were no significant differences for the other statements regarding the ability to understand recommendations, courtesy, and knowledge of the physician. Regardless of group, 98.6% of caregivers agreed with surgical recommendation when surgery was recommended. However, when surgery was not recommended at the appointment, caregivers were 11x more likely to disagree with the surgical recommendations, OR:11.49,95%CI:1.44-91.38,p = .005., Conclusion: We conclude that telemedicine was equally well received by patients as compared to traditional live assessments suggesting that virtual care is a viable post-pandemic paradigm change. Satisfaction was rated as "Good" or "Excellent", however, messaging when surgery is not recommended was less acceptable and must be improved to obtain increased caregivers' agreement in an era of shared decision making., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: Extensive literature exists documenting disparities in access to healthcare for patients with lower socioeconomic status (SES). The objective of this study was to examine access disparities and differences in surgical wait times in children with the most common pediatric otolaryngologic surgery, tympanostomy tubes (TT)., Methods: A retrospective cohort study was performed at a tertiary children's hospital. Children ages <18 years who received a first set of tympanostomy tubes during 2015 were studied. Patient demographics and markers of SES including zip code, health insurance type, and appointment no-shows were recorded. Clinical measures included risk factors, symptoms, and age at presentation and first TT., Results: A total of 969 patients were included. Average age at surgery was 2.11 years. Almost 90% were white and 67.5% had private insurance. Patients with public insurance, ≥1 no-show appointment, and who lived in zip codes with the median income below the United States median had a longer period from otologic consult and preoperative clinic to TT, but no differences were seen in race. Those with public insurance had their surgery at an older age than those with private insurance ( P  < .001) and were more likely to have chronic otitis media with effusion as their indication for surgery (OR: 1.8, 95% CI: 1.2-2.5, P  = .003)., Conclusions: Lower SES is associated with chronic otitis media with effusion and a longer wait time from otologic consult and preoperative clinic to TT placement. By being transparent in socioeconomic disparities, we can begin to expose systemic problems and move forward with interventions., Level of Evidence: 4., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Pediatric patients require tracheostomy tube placement as a last resort for critical airway management. Around-the-clock care is needed at discharge because of the high risk of morbidity and mortality associated with a tracheostomy. The potential for catastrophic sequalae can create a high stress home environment. A simulation program that used a high-fidelity manikin was implemented to reduce complications, morbidity and mortality, and improve skills for real-life medical scenarios., Methods: A tracheostomy care simulation program was implemented at a large tertiary care children's hospital from October 2019 to October 2020. Caregivers participated in a pre-post program survey and rated 9 statements on a 5-point scale with regard to knowledge, confidence, and comfort level of taking care of their child at home. Emergency scenarios included accidental tracheostomy tube dislodgement, tracheostomy tube plugging, cardiac arrest, and ventilator failure. Classes were recorded for objective start-to-finish scenario time stamps and prompt rates. A medical chart review was performed 90 d after discharge., Results: Eighteen caregivers for 10 children participated. For the 10 children, there was a 9.1% increase in the average total score agreement from pre to post survey, with scores going from "agree" to "strongly agree" ( P = .001). Each subset of questions had a significant increase in scores after participation: knowledge, P = .002; confidence, P = .006; and comfort, P = .01. The caregivers required an average 20% prompt rate for the next step in the scenario. Children were 70% female, 80% white, and 60% had public insurance and had their tracheostomy tube placed at a median age of 4 months (range, 0 months to 24 years). Three children ( n = 3/9 [33.3%]) were readmitted for tracheitis within 90 d after being discharged to home., Conclusions: Caregiver knowledge, confidence, and comfort levels were increased after participation. Pediatric patients with a tracheostomy are medically fragile, therefore, it is important for caregivers to be aware of and prepared for common tracheostomy emergencies and to "experience" emergency situations firsthand., Competing Interests: The authors have disclosed no conflicts of interest. A Trilogy 100 ventilator was supplied by Philips Respironics Sleep and Respiratory Care for educational and research purposes., (Copyright © 2022 by Daedalus Enterprises.)

Objectives: Evaluate health-related quality-of-life (HRQoL) measures in noncommunicative, neurologically impaired, developmentally delayed (NCNIDD) children compared to normally developing children (ND) who undergo cochlear implantation (CI)., Study Design: Cross-sectional survey of parents of NCNIDD and ND children who underwent CI., Setting: Two tertiary care medical centers., Methods: Questions comprising the Children With Cochlear Implants: Parental Perspectives survey were used in analysis. Average responses were calculated within 8 domains (communication, general functioning, self-reliance, well-being and happiness, social relationships, education, effects of implantation, and support the child). Groups were compared using Wilcoxon rank-sum test. Impact of individual and collective socioeconomic/family covariates was assessed using analysis of variance., Results: Surveys were returned from 17 of 42 (40%) patients with NCNIDD and 35 of 131 (27%) patients with ND. There were no statistically significant differences between groups in survey response rate, age, sex, age at implantation, current age, or duration of implant use. Overall, parents of children with ND responded more favorably in all domains vs children with NCNIDD. Parents of children with NCNIDD answered neutrally or favorably in all domains, except "support the child" and "self-reliance" domains. Differences between groups in mean domain scores, univariably and almost universally when adjusting for socioeconomic and family variables individually and collectively, were statistically significant., Conclusions: This study suggests that HRQoL benefits of CI are perceived in most domains by parents of children with NCNIDD, albeit less strongly than children with ND. A survey sensitive to challenges of children with NCNIDD may better capture benefits that may not be apparent in this study.

Purpose: Recent data have challenged the historical paradigm that cystic fibrosis (CF) protects against otitis media (OM). These findings raised questions about the pathogenesis of this ostensible change. In this study our aim is to characterize acute OM (AOM) risk based on CF genotype., Methods: A retrospective chart review was completed at a tertiary care pediatric hospital. Charts of 159 CF patients seen at our facility from 2010 to 2019 were reviewed. Data collected included demographics, AOM infections, cystic fibrosis transmembrane conductance regulator (CFTR) allele mutations, pulmonary exacerbations (PE), and pancreatic insufficiency (PI) status. Mutation alleles were divided into five classes based on CF guidelines, which were further classified as severe (classes I-III) or mild (classes IV-V)., Results: 54% of patients had at least one episode of AOM with a mean of 1.5 episodes of AOM (standard deviation = 2.3). 86% of patients had severe/severe (S/S) alleles and 14% had severe/mild (S/M). S/S patients had significantly more PE (p = .004) and increased rates of PI (p < .001). Of the 131 patients with S/S mutations, 57% had an episode of AOM while only 46% the 22 S/M patients had an AOM episode (p = .357)., Conclusions: To our knowledge this is the first report showing a clinical trend towards increased middle ear disease in patients with severe CFTR mutations. Future prospective studies will be powered to demonstrate whether this trend is statistically significant. Patients with S/S mutations not only have more severe clinical phenotypes but may have additional unexpected complications such as middle ear disease., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To determine if children with cystic fibrosis (CF) who are otitis media prone and treated with tympanostomy tube placement (TTP) follow the natural course of non-CF children regarding the incidence of tympanostomy tube otorrhea (TTO) (21-34%)., Methods: All CF patients seen at a large tertiary pediatric hospital were retrospectively reviewed from 2010 to 2019. A total of 483 patients were identified and seventeen met the inclusion criteria and were included in the analysis. Data collected included demographics, CF diagnosis history including date of diagnosis and genotype, TTP notes, and otorrhea found in otolaryngology clinic and pediatrician clinic notes for up to 18 months post-TTP., Results: CF was diagnosed at a median age of 13 days (0 days to 6 years). In terms of surgical frequency, 14/17 (82.4%) patients had one TTP, 2/17 (11.8%) had two TTPs, and 1/17 (5.9%) had five TTPs. The median (range) age at first TTP was 2 years (3 months to 13 years). After the first TTP, TTO occurred in 5 (29.4%) patients at 3 months, 6 (35.3%) at 6 and 9 months, and 7 (41.2%) at 12 and 18 months at median (range) = 1 (0-5) otolaryngology appointments and median (range) = 0 (0-8) pediatrician appointments., Conclusion: To our knowledge this is the first study to report that CF children are more likely to be severely affected with recurrent acute otitis media (RAOM), to require TTP, and to exhibit a natural history of TTO commensurate with the non-CF population., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Children with Down syndrome (DS) have a higher incidence of tympanostomy tube insertion (TTI) than children in the general population. As there were no studies investigating factors that are associated with multiple TTIs in children with DS, we sought to determine what factors increase or decrease the likelihood of repeat TTI in children with DS., Methods: A retrospective case-control study was performed on consecutive children with DS from 2007 to 2018 with first TTI at a large tertiary children's hospital and follow-up duration at least 27 months since first TTI., Results: 277 patients met the inclusion criteria. Repeat TTI rate was 61.4%. Having an indication of chronic otitis media with effusion (COME) at first TTI was an adjusted risk factor for increased rate of repeat TTI (OR: 2.01, 95%CI: 1.15-3.51, p = .014), while being older at first TTI was an adjusted protective factor for decreased rate of repeat TTI (OR: 0.84, 95%CI: 0.74-0.95, p = .004). Adenotonsillectomy at or before first TTI was not an adjusted protective factor for decreased rate of repeat TTI (OR: 0.915, 95%CI: 0.448-1.872, p = .809) and bilateral intra-operative fluid was not an adjusted risk factor for repeat TTI (OR: 1.97, 95%CI: 0.99-3.90, p = .054)., Conclusion: Children with DS were more likely to undergo repeat TTI if they were of younger age and if the indication for surgery was COME. The repeat TTI rate for children with DS was high at 61.4%. Prospective studies are warranted to more precisely investigate factors associated with repeat TTIs in this unique patient population., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Introduction: Post-tonsillectomy hemorrhage (PTH) is a serious complication after a tonsillectomy. Utility of lab work at presentation for PTH was low. This study aims to determine the frequency and type of labs drawn at emergency department (ED) presentation and assess the incidence of uncovering a previously unidentified coagulopathy., Methods: A retrospective chart review was performed on pediatric patients who were seen in the ED after tonsillectomy at a tertiary care children's hospital from 2017 to 2019. Exclusion criteria were the following: no tonsillar bleed, history of known coagulopathy, treated by outside provider, ≥18 years old. Lab work included complete blood count (CBC), prothrombin time (PT), partial thromboplastin time (PTT), and von Willebrand factor (VWF)., Results: 364/723 (50.3%) patients met inclusion criteria. 179/364 (49.2%) patients were male and 309/364 (84.9%) patients were Caucasian. Average age at surgery was 8.12 years (SD = 4.0) and average post-operative day at presentation was 6 days (SD = 2.1). Operative control of bleed was performed in 68/364 (18.7%) patients. 334/364 (91.8%) patients had labs drawn in the ED. 64/334 (19.1%) patients were anemic (hemoglobin (Hgb) < 11), 46/334 (13.8%) patients had thrombocytosis (platelets>450,000), 10/334 (3.0%) had elevated PTT and 8/334 (2.4%) had elevated PT. Hematology was consulted in 14/364 (3.8%) patients of whom 6/14 were diagnosed with von Willebrand disease and 1/14 with factor VII deficiency. Aminocaproic acid was used in 8/364 (2.2%) patients due to elevated PTT in 3/8 and multiple episodes of bleeding in 5/8.3/364 (0.8%) patients needed a blood transfusion. No difference was found in incidence of abnormal lab work in patients who did and did not need operative control of bleed (p = .125). Of the 334 patients who had ED labs drawn, 7 (2.1%) had an uncovered coagulopathy., Conclusion: Uncovering incidental coagulopathies is rare in patients who present with PTH. Though anemia was the most common abnormality noted, only a small percentage required transfusion, with all having abnormal vital signs. Thrombocytosis was the next common abnormality, and this can be seen in an inflammatory state. Developing algorithms is necessary to better guide appropriate lab work in patients who present with PTH and to provide optimal value of care to patients., (Copyright © 2021. Published by Elsevier B.V.)

Objectives: Pediatric patients who undergo tracheostomy tube placement are medically complex with a high risk of morbidity and mortality. They are often premature with multiple cardiopulmonary comorbidities. This study reviews the demographics and outcomes within this population to identify at-risk patient groups at our hospital., Methods: A retrospective chart review of those with pediatric tracheostomy placement from 2015 to 2016 at our hospital was performed (n = 92). Demographic and post-discharge data were collected at 30, 60, and 90-days during the global period., Results: Ventilator dependence was the most common reason for placement. 79.3% of patients had two or more major comorbidities. 44% had an emergency department (ED) visit and subsequent hospital admission within the first 90 days post-discharge, with 36% being trach/respiratory-related. The 90-day mortality was 19.6%; however, at the time of chart review, mortality was 35% with only 1 (1.1%) being from trach-related complications. Patients with longer admissions were more likely to die prior to discharge, p = .001. Lastly, patients who died were 3 times more likely to have > 25% no-shows to their outpatient appointments compared to those living throughout the study period., Conclusion: Our population had a high incidence of ED visits, readmission rates, and mortality; however, trach-related causes remained low. Mortality risk increased with more no-show appointments and residing a further distance from our hospital. Furthermore, multiple co-morbidities, with longer hospital stays also increased risk of mortality. Identifying those with the highest risk for complications will enable us to target families for increased home-care education to decrease readmissions and mortality., Level of Evidence: 4., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objective: Measure the prevalence of and factors associated with financial toxicity (FT) and caregiver burden in families of tracheostomy-dependent children. FT is defined as the objective and subjective patient-level impact of the costs of medical care and has been associated with lower quality of life, decreased compliance with treatment, and increased mortality., Methods: A medical record review was performed on all children with a tracheostomy tube placed from 2009 to 2018 at a tertiary children's hospital to identify and include children younger than 18 years old, not deceased, and not decannulated at the time of review. Eligible children's caregivers were contacted to fill out a 36-item questionnaire and three validated instruments: The Comprehensive Score for Financial Toxicity (COST) and the Financial Distress Questionnaire (FDQ), both addressed to the parent/primary caregiver, and the Burden Scale for Family Caregivers - short version (BSFC-s)., Results: Of the 140 eligible tracheostomy patients identified, 45 caregivers (32.1%) returned the survey. The average COST score was 18 ± 1.7 with 73.3% of caregivers reporting high toxicity based on FDQ, and 75.6% having severe-to-very severe caregiver burden. Significant increase in FT was seen in households where an adult had to leave a paid position (p = 0.047) or work less (p = 0.002) because of their child's condition; or needed to omit some of the child's medical services or medications due to cost-prohibitive reasons (p<0.001). Financial toxicity was associated with caregiver burden (by BSFC-s) [r = -596; beta coefficient = -0.95, t(43) = -4.87, p<0.001] and financial distress (by FDQ; p<0.001)., Conclusion: Caregivers of children with medically complex, tracheostomy-dependent conditions suffer from FT and caregiver burden. As a result, harmful financial coping mechanisms such as missing necessary care components or forgoing prescribed treatments, may be adopted for cost-prohibitive reasons., (Copyright © 2021. Published by Elsevier B.V.)

Objective: (1) Review a multidisciplinary vascular anomalies center's practice regarding periprocedural anticoagulation for venous malformations (VM) and the associated risk of thromboembolic and disseminated intravascular coagulation (DIC) events. (2) Compare the risk of thromboembolic events and DIC post-procedure between head and neck (H&N) and extremity VM patients., Methods: An Institutional Review Board (IRB)-approved, retrospective chart review was performed on 120 VM patients. A thromboembolic event was defined as a thrombus formation post-sclerotherapy or post-surgery within 2 months in a distant or local venous structure not directly addressed by the procedure., Results: There were 39 cases involving the H&N and 81 cases based at the extremities. There were eight cases of post-procedure thrombus formation within the extremity VM group (8/71; 11.3%) as opposed to 0 cases in the H&N group (OR: 0, 95% CI .00-.09), p = .049. There was no difference in incidence of post-procedure thromboembolic events between those with elevated D-dimer (H&N: 0%, extremity: 22.7%, 5/22) and normal D-dimer values (H&N: 0%, extremity: 6.3% [1/16], P = .370). There was no difference in incidence of post-procedure thromboembolic events between those who received periprocedural anticoagulation (H&N: 0%, extremity: 21%, 4/19) and those who did not (H&N: 0%, extremity: 8.2%, 4/49), (Extremity: OR: 3.00, .67-13.50, P = .206)., Conclusion: Post-procedure thromboembolism is rare in the treatment of venous malformations, especially in the head and neck subsite. Regardless of anticoagulation use, there were no thromboembolic events for H&N VM patients. Such events are rare, and the odds may approach zero, especially with small sample size., Level of Evidence: 4 Laryngoscope, 131:1163-1167, 2021., (© 2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).)

Objectives/hypothesis: To determine the utility of preoperative penetration-aspiration scale (PAS) scores and clinical findings on modified barium swallow (MBS) in predicting advancement of diet after interarytenoid injection augmentation (IAIA)., Study Design: Retrospective review., Methods: In this retrospective cohort study, 372 consecutive patients who underwent IAIA for pharyngeal dysphagia between 2009 and 2019 were initially identified. Patients were excluded from the study if they had insufficient preop MBS, no postop MBS within 3 months of injection, supraglottoplasty, or underlying neurological condition. Ninety-three patients were included in the study. Pre- and postoperative PAS scores were recorded, as were pre and postop diets. PAS scores were calculated by a single pediatric speech and language pathologist., Results: Average PAS score on MBS was 5.87 (standard deviation [SD] 2.74); median (range) = 8 (1-8). Postop average was 4.29 (SD 3.02); median (range) = 2 (1-8), P < .001. Those with worse preop PAS scores had increased odds of improvement in diet (odds ratio 1.24, 95% confidence interval [CI] 1.02-1.49, P = .029). An improvement in PAS score of 3.0 or greater predicted an improvement in diet with a sensitivity of 76.7% and a specificity of 85.7%., Conclusions: PAS score on MBS can be a useful tool when assessing pediatric patients who may be candidates for IAIA. Prospectively comparing PAS score in patients post-IAIA to patients solely undergoing diet modification can help to better objectively assess differences in outcomes and understand the full utility of PAS score., Level of Evidence: Level III (Individual Cohort Study) Laryngoscope, 131:E1707-E1713, 2021., (© 2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).)

Introduction: Subperiosteal orbital abscess (SPOA) is a serious suppurative complication of pediatric sinusitis. The objective of this study is to stratify patient selection into those best treated medically versus surgically based on clinical outcomes., Methods: This is a retrospective review of patients diagnosed with SPOA complicating sinusitis treated at a tertiary care pediatric hospital from 2002 through 2016. SPOA was diagnosed by CT scan. Characteristics evaluated include demographics, abscess size, location, and measurements, length of hospital stay, medical and surgical interventions, presenting symptoms, and complications., Results: A total of 108 total SPOA secondary to sinusitis patients were included. A majority, 72.2%, were male with an average age at presentation of 6.8 years. The mean ± standard deviation abscess cubic volume was 0.98 ± 1.27 cm 3 (median(range) = 0.44(0.01-7.34 cmcm 3 )). With an abscess volume of 0.510 cm 3 , there was a sensitivity of 71.2% and a specificity of 84.4% for needing surgical drainage. Those with large abscesses at our volume threshold were 13 times more likely to require surgery than those with small abscesses, OR: 13.41, 95%CI: 5.02-35.86, p < .001. Patients that required surgery had an abscess closer to the orbital apex with the majority, 25 (61.0%), being the most proximal to the apex, p = .004. The likelihood of surgery decreased with increased distance from the orbital apex in medial abscesses (OR:.92, 95%CI: 0.86-0.98, p = .009)., Conclusion: In the pediatric population, SPOA is a serious consequence of sinusitis. This study provides evidence supporting that larger abscess size is a significant risk factor for requiring surgery. The appeal of our study is that it provides evidence and support that employ clinical parameters already assessed as standard practice in evaluating these patients. In summarizing the clinical translational relevance of our study, when determining whether to treat a patient with surgery and antimicrobial/medical therapy vs. non-surgical medical therapy alone, the clinician should focus on size of 0.510 cm 3 or larger for abscesses in any location as a relative indication for surgery., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objective: To determine if barriers to cochlear implantation (CI) exist with respect to Amish children and to describe unique considerations associated with CI and subsequent otologic care in the Amish population., Methods: Out of all patients who underwent CI at a tertiary care pediatric hospital from 2008 to 2019, Amish children were age-matched to the remainder of the cohort to compare demographics and care-related metrics including etiology of hearing loss, age at time of initial hearing-related appointment and at CI, total number of pre- and post-operative audiologic and otologic appointments, and post-operative complications. Social considerations that may pose barriers to care were collected for descriptive analysis., Results: Since 2008, 232 children underwent CI, of which 8 implants were performed on Amish children. Six (75%) Amish children underwent newborn hearing screening and 3(38%) were found to have syndromic etiology for hearing loss. While Amish patients had a lower number of both audiologic (15 vs 33.5, p<.001) and otologic (4.5 vs 8.5, p=.028) appointments when compared to age-matched controls, median age at the time of implantation for the whole sample was not different between groups (2.5 vs 2.0 years, p=.211). From a social standpoint, limitations in transportation, telephone communication, and ability to recharge processor batteries must be considered in the Amish population., Conclusion: Amish children undergoing CI face unique barriers to care including transportation and technologic limitations, leading to overall fewer hearing-related appointments when compared to an age-matched cohort. Understanding societal differences is important to facilitate optimal care for Amish children with hearing loss., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: Coblation and electrocautery are two common techniques used for adenotonsillectomy (T&A). Numerous studies have assessed surgical outcomes of coblation versus electrocautery and overall, postoperative complications are similar with the exception of a decrease in patient reported postoperative pain for coblation. Instrumentation required for coblation is significantly more expensive than that required for electrocautery. With minimal outcome differences, justification for the additional instrumentation costs is difficult. We performed this study to assess if there is a difference between operative & postoperative costs of electrocautery and coblation., Methods: 300 patient medical records were reviewed from 2015 to 2017 with equal numbers of electrocautery and coblation surgeries. Outcome measures included finance information, duration and cost of OR and Phase I and Phase II post-anesthesia care unit (PACU), in-hospital pharmacy costs, and postoperative complications. Logistic regression was used for analysis., Results: The median patient age for each surgical technique was 6 years old. Electrocautery resulted in more time in the OR compared to coblation, (OR:1.11,95%CI:1.07-1.15, p < .001), with greater associated costs, p < .001. Electrocautery patients were under anesthesia longer and had a longer surgical duration, p < .001. These same patients had longer duration in Phase II PACU, p = .028, and were given pain medications an increased number of times, p < .001. Total costs including operative expense, physician charges, OR and anesthesia times, pharmacy, and instrument were significantly higher for electrocautery patients, p = .003. There were no differences in ED visits, post-tonsillectomy bleed, or additional surgery between techniques, p > .05., Conclusion: T&A electrocautery technique was found to have increased overall indirect costs. Costs of instrumentation in addition to increased operative time, use of analgesics and post-operative care contribute to costs associated with electrocautery and coblation should be used when assessing surgical costs., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Introduction: Two of the most commonly employed bone-anchored hearing implant (BAHI) systems are the BAHA Connect and BAHA Attract. The BAHA Connect uses a skin-penetrating titanium abutment. The BAHA Attract uses an implanted magnet, leaving the overlying skin intact. Limited data is available on the difference in complication rates between the two systems. Our hypothesis was that there would be no difference in complications and audiologic data., Methods: Retrospective chart review was performed of patients who had BAHA Connect vs. Attract at our tertiary care pediatric hospital from 2006 to 2018. Pre- and post-operative information, including demographics, related diagnoses, outcomes and complications were compared between the systems using Mann-Whitney U tests and Firth logistic regression for one year post-implant. Audiology data was analyzed with Wilcoxon rank-sum and Wilcoxon matched pairs signed rank tests., Results: Twenty-four Attract and 18 Connect BAHA surgeries were identified from 37 patients. Eleven Connect patients had the surgery completed in two stages. Connect patients followed up an average of 6.5 years post-implant and 15 months for Attract. A total of 58.8% of patients with Connect surgeries had complications within a year and 82.4% had a complication by their last follow-up. Aside from magnet strength related issues, there were no major complications with Attract surgery at any time point. Patients with Connect surgeries had significantly more skin overgrowths, cultured infections, times on antibiotics, nursing phone calls, and ENT visits within the first year and for all records, p < .05. The pure-tone average was significantly lower for both Connect [unaided-M(SD) = 61.7(9.8); aided-M(SD) = 26.4(5.5) and Attract (unaided-M(SD) = 66.0(22.5); aided-M(SD) = 25.6(6.1)] after implant, p < .001., Conclusion: Implantation of both systems lead to improved hearing outcomes with profoundly different complication rates., Competing Interests: Declaration of competing interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Introduction: Historically cystic fibrosis (CF), in contrast to primary ciliary dyskinesia (PCD), has been considered protective of the middle ear from otitis media and rarely were such patients "severely affected" to require tympanostomy tube placement (BMT). Previously the Pittsburgh Otitis Media Research group reported a 10% prevalence of otitis media in the pediatric CF population which is significantly lower than age matched non-CF children. We studied the prevalence of OM in pediatric CF patients to assess if the otologic phenotype has changed in parallel with changes in the diagnosis itself., Methods: The medical records of 133 CF patients seen either inpatient or outpatient from one of the largest tertiary pediatric CF centers in the world from 2010 to 2019 were reviewed for demographics, acute otitis media (AOM) episodes, risk factors for AOM, placement of myringotomy tubes, genotype, BMI, pancreatic status, respiratory culture results, and pulmonary exacerbations., Results: Just over half (52.6%) the patients were male. A median age for CF diagnosis was 11 days old (range 0 days-16 years). The most common genotype (49.6%) was homozygous for ΔF508 mutation. Fifty-five (41.4%) patients had 1-2 episodes of AOM, and 15 (11.3%) were severely affected (i.e. ≥3 episodes/6 months or ≥4 episodes/year). COME was diagnosed in 4 (3.0%) of the patients. Twelve (9.0%) patients had tympanostomy tubes at least once, including 3 patients with multiple sets of tubes. Having at least one AOM episode was not predicted by genetic mutation groups, BMI, age at diagnosis, or comorbidities, p > .05., Conclusions: The time-honored adage of CF protecting against otitis media is no longer true and pediatric otolaryngologists must now prioritize the management of middle ear disease as highly as sino-nasal and pulmonary disease. Future study into mechanisms explaining the change is needed., Competing Interests: Declaration of competing interest There are no conflicts of interest to report for any author., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Impaired mitochondrial function has been associated with the etiopathogenesis of Parkinson's disease (PD). Sustained inhibition of complex I produces mitochondrial dysfunction, which is related to oxidative injury and nigrostriatal dopamine (DA) neurodegeneration. This study aimed to identify disease-modifying treatments for PD. Unsubstituted phenothiazine (PTZ) is a small and uncharged aromatic imine that readily crosses the blood-brain barrier. PTZ lacks significant DA receptor-binding activity and, in the nanomolar range, exhibits protective effects via its potent free radical scavenging and anti-inflammatory activities. Given that DAergic neurons are highly vulnerable to oxidative damage and inflammation, we hypothesized that administration of PTZ might confer neuroprotection in different experimental models of PD. Our findings showed that PTZ rescues rotenone (ROT) toxicity in primary ventral midbrain neuronal cultures by preserving neuronal integrity and reducing protein thiol oxidation. Long-term treatment with PTZ improved animal weight, survival rate, and behavioral deficits in ROT-lesioned rats. PTZ protected DA content and fiber density in the striatum and DA neurons in the SN against the deleterious effects of ROT. Mitochondrial dysfunction, axonal impairment, oxidative insult, and inflammatory response were attenuated with PTZ therapy. Furthermore, we have provided a new insight into the molecular mechanism underlying the neuroprotective effects of PTZ., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Cell-mediated immune (CMI) responses to tumor-associated antigens (TAA) in the early postoperative period were examined for correlations with disease recurrence and survival in a 13-year-prospective study of 77 stage 1 and 2 breast cancer patients treated with modified radical or radical mastectomy alone. Among the 21 patients who had positive lymphoproliferative tests using patients' peripheral blood mononuclear cells and autologous TAA of breast cancer cells, only one died from metastatic disease (5%). Among the 56 patients who had a negative test, 23 died from metastatic disease (41%). This difference is statistically significant (p = 0.002) Three other risk factors including tumor size, nodal status and cell differentiation patterns were also analyzed. When these three clinical-pathologic criteria were analyzed individually, none reliably predicted disease recurrence and survival. Nodal status was the most predictive clinical-pathologic risk factor, but was not significant (p = 0.089). The results of this study demonstrate the detection of CMI responses against autologous TAA by lymphoproliferative assays identifies a sub-set of stage 1 and 2 breast cancer patients who are at minimal risk of developing metastatic disease. This testing also identifies immunologically unreactive patients who are at risk for disease recurrence.

This article reports on the hazard of mortality of aging retired- and disabled-worker men over the decade after they became Social Security beneficiaries. Basic patterns of mortality rates are described using data from the 1982 New Beneficiary Survey linked to administrative records. The article examines the association of increasing age, race, socioeconomic status, private health insurance, and other demographic and health characteristics with the duration of life between the two groups of men, using statistical models. Over the decade, the hazard of death for retired workers significantly increased with aging and with lower socioeconomic status. The hazard of death for the disabled was significantly associated with being black.

Data from the 1982 New Beneficiary Survey (NBS) were matched with 5 years (1984-88) of Social Security and Medicare data to analyze disabled workers' probability of death and inpatient care. Fifteen percent of the disabled workers died within 18-24 months of initial eligibility; 34 percent died within 5 years. Older disabled workers had higher probabilities of death and hospitalization. Males were two times as likely to die as females, but no more likely to be hospitalized. Black persons also had a higher risk of death but no greater risk of hospitalization than other races. Additional health insurance had no influence on survival, but was differentially associated with inpatient care. Married males were more likely to survive. Physical functioning capacity had no influence on survival or hospitalization. Respiratory, circulatory, and digestive disorders increased the probability of hospitalization and mortality.

Geographic patterns of county prevalence rates of disability benefit receipt are shown for the Social Security Administration's Disability Insurance (DI) and Supplemental Security Income (SSI) programs. Prevalence rates were calculated by dividing each county's December 1990 DI and SSI disability caseloads by the population aged 18-64 for that year in that county. Separate maps were also constructed for men and women recipients. Areas with the highest overall DI prevalence rates included Appalachia, the Southeast Coastal Plains, the Mid-south, northwestern Montana, the coastal counties of Washington, and isolated counties of the Southwest. Areas with the highest SSI prevalence rates included the Mississippi Delta, scattered counties in Oklahoma, the Missouri "Boot Heel," parts of Appalachia, isolated counties in South and North Dakota, the "Four Corners" regions of the Southwest, the Sacramento and San Joaquin Valley regions of California, isolated parts of the upper Great Lakes States, northern Maine, and the coastal region of southwestern Alaska. Disability prevalence rates were also calculated for the overall population and by sex for each of the 10 U.S. Department of Health and Human Services administrative regions.

The dose-response relationship (challenge phase) of the skin sensitization response was investigated in previously sensitized Hartley guinea pigs. Larger numbers of animals were used per group at the lower doses so that statistically significant observations could be made. Model compounds known to be skin sensitizers were used: a strong sensitizer, dinitrochlorobenzene (DNCB), and a weaker sensitizer, p-phenylenediamine (PPDA). A gradation in response to changing DNCB doses was easily observed by using either the open epicutaneous test (OET) or the Buehler occlusive patch test. The Buehler test was used to study the dose-response relationship of DNCB sensitization. The sensitivity of the OET and Buehler test was judged not adequate to measure the dose response for PPDA, because at high doses a high incidence of responders was not obtained. Therefore, the maximization test was used to evaluate PPDA. Similar, non-linear dose-response curves were obtained with each compound. The higher doses produced a somewhat linear relationship, but at lower doses the curves flattened out and more slowly approached a zero response. Thus, for potent sensitizers, concentrations found in exposure situations might be in the linear portion of the dose-response curve. For weak responders, use concentrations might be in the shallow portion of the curve, where reactions would be underestimated if a linear dose-response curve were assumed.

Estrogen (ER) and progesterone receptor (PgR) content of tumors were determined by both the dextran-coated charcoal (DCC) cytosol and immunocytochemical assays (ICA), and these hormone receptor results were compared to lymphocyte immunity against tumor antigen(s) for 52 breast carcinoma patients. Hormone receptor analysis by both methods demonstrated that 60% of the patients' tumors had ERs, while 44% were positive for PgRs. The ICA procedure was more sensitive than the cytosol technique for determining PgR content of the tumors. This increased sensitivity was not observed for ER by ICA. Patient age, tumor size, and nodal status were not related to the ER and PgR receptor status. A total of 21/52 (40%) of the patients had positive lymphocyte immunity against tumor antigen. This immunity was independent of patient age, tumor size, and nodal status. There was no significant relationship between lymphocytic immunity against tumor antigen and ER or PgR content of tumors, suggesting that patient lymphocyte immunity against tumor is independent of hormone receptor status. This is further evidence that lymphocyte immunity against tumor antigen status is an independent prognostic indicator that may be useful in the selection of a subset of node negative patients for adjuvant chemotherapy.

Fifty-two breast cancer patients were evaluated for levels of several molecules related to iron metabolism including determining their tumor tissue and serum ferritin levels, serum transferrin levels, and serum iron levels. In addition the patients' lymphocyte immunity against autologous tumor antigen was investigated. Forty percent (21 of 52) of the patients had lymphocyte immunity against tumor antigen. Iron metabolism molecules were expressed in abnormal quantities in some breast cancer patients: 27% (13 of 49) had elevated tumor tissue ferritin levels, 4% (2 of 49) had abnormally high serum ferritin, 10% (5 of 49) had abnormally low serum transferrin levels, and 43% (21 of 49) had depressed serum iron levels. None of these abnormalities in iron metabolism are associated with tumor immunity. These iron metabolism molecules may be indicative of rates of cell proliferation or may influence growth of breast cancer cells, but do not appear to influence host lymphocyte immunity against tumor associated antigens.

One hundred forty-two breast cancer patients were evaluated for three functional immunologic parameters: the ability of their lymphocytes to proliferate in response to general T-(phytohemagglutinin) and B-lymphocyte (pokeweed mitogen) stimulators and their ability to proliferate in response to specific autologous tumor antigens. Tests were performed on patient blood specimens collected approximately 2 hours prior to surgery or 2-4 weeks following chemotherapy. T-lymphocyte functional competence was impaired in 83/142 (58%) of the patients, while B-lymphocyte competence was impaired in 34/142 (24%) of these patients. A total of 21/52 (40%) of the patients had lymphocyte immunity against autologous tumor antigen. There were weak associations between the ability of patients' T- and B-lymphocytes to function normally, and their ability to respond to autologous tumor-antigen. There was no relationship of age, tumor burden (clinical or pathological tumor size), extension to skin and/or muscle, or metastasis to any of the three immunological parameters. A relationship (p = 0.0463) between T-lymphocyte competence and pathological nodal status was observed; individuals that were node positive for disease, tended to have impaired T-lymphocyte function. When evaluating T- and B-lymphocyte competence and lymphocytic immunity against tumor antigen in pre- and post-chemotherapy patients, an immunologic rebound (increase in immune parameters shortly after completion of chemotherapy) was observed in some patients. These results demonstrate the utility of measuring these immune parameters in breast cancer patients, their relevance to the natural biology of the disease, and the influence that chemotherapy may have on host immune function.