Evidence for validity of the epidemic-pandemic impacts inventory (brief healthcare module): Internal structure and association with other variables.

The COVID-19 pandemic has subjected healthcare workers to enormous stress. Measuring the impact of this public health emergency is essential to developing strategies that can effectively promote resilience and wellness. The Epidemic-Pandemic Impacts Inventory Supplemental Healthcare Module-Brief Version (EPII-SHMb) was developed to measure impacts among occupational cohorts serving on the front lines of healthcare. While this instrument has been utilized in COVID-19 related studies, little is known about its psychometric properties. This study collects evidence for validity of the EPII-SHMb by evaluating its internal structure and how its scores associate with other variables. Physicians and nursing staff across a large New York health system were cross-sectionally surveyed using an online questionnaire between June and November 2020. Exploratory factor analysis resulted in a 3-factor solution, identifying factors Lack of Workplace Safety (7 items), Death/Dying of Patients (3 items), and Lack of Outside Support (2 items). Internal consistency was high overall and within physician/nursing and gender subgroups (Cronbach's alpha: 0.70 - 0.81). Median scores on Death/Dying of Patients were higher among those who directly cared for COVID-19 patients or worked in COVID-19 hospital units. These results are promising. Additional studies evaluating other dimensions of validity are necessary.

The Impact of Physicians' COVID-19 Pandemic Occupational Experiences on Mental Health.

OBJECTIVE: To examine the association between a number of negative COVID-19 occupational experiences and probable anxiety, depression, and PTSD among physicians. METHODS: Cross-sectional examination of longitudinal registry data consisting of physician personal and occupational well-being. Multivariable logistic regressions were performed to determine the association between negative COVID-19 experiences and outcomes. RESULTS: Of the 620 eligible physicians, approximately half were female (49%), and 71% white with a mean age of 46.51 (SD = 13.28). A one-point increase in negative experience score was associated with a 23% increase in probable anxiety (OR = 1.23, 95% CI: 1.14-1.34), a 23% increase in probable depression (OR = 1.23, 95% CI: 1.13-1.33), and a 41% increase in probable PTSD (OR = 1.41, 95% CI: 1.30-1.52). CONCLUSIONS: Negative pandemic experiences were strongly associated with adverse mental health outcomes while greater resilience was protective.

Evaluating burnout during the COVID-19 pandemic among physicians in a large health system in New York.

PURPOSE: The COVID-19 pandemic has generated significant psychological distress among health care workers worldwide. New York State, particularly New York City and surrounding counties, were especially affected, and experienced over 430,000 COVID-19 cases and 25,000 deaths by mid-August 2020. We hypothesized that physicians and trainees (residents/fellows) who were redeployed outside of their specialty to treat COVID-19 inpatients would have higher burnout. METHODS: We conducted a cross-sectional survey to assess burnout among attending and trainee physicians who provided patient care during the COVID-19 pandemic between March-May 2020 across a diverse health care system in New York. Separate multivariable logistic regressions were performed to determine the association between redeployment and measures of burnout: Emotional Exhaustion (EE) and Depersonalization. Burnout measures were also compared by physician vs trainee status. The differential association between redeployment and outcomes with respect to trainee status was also evaluated. RESULTS: Redeployment was significantly associated with increased odds of EE {OR =1.53, 95% CI: 1.01-2.31} after adjusting for gender and Epidemic-Pandemic Impacts Inventory (EPII) score. Similarly, being a trainee, especially a junior level trainee, was associated with increased odds of EE {OR = 1.59, 95% CI: 1.01-2.51} after adjusting for gender and EPII scores. However, neither redeployment nor trainee status were significantly associated with Depersonalization. Interactions between redeployment and trainee status were not significant for any of the outcomes (p>.05). CONCLUSION: Physicians who were redeployed to treat COVID-19 patients had higher reported measures of EE. Trainees, irrespective of redeployment status, had higher EE as compared with attendings. Additional research is needed to understand the long-term impact of redeployment on burnout among redeployed physicians. Programs to identify and address potential burnout among physicians, particularly trainees, during pandemics may be beneficial.

The impact of cochlear implantation on speech and language outcomes in children with asymmetric sensorineural hearing loss.

INTRODUCTION: Cochlear implantation (CI) is considered in children with asymmetric sensorineural hearing loss (ASHL), or severe to profound sensorineural hearing loss in one ear, and better hearing contralaterally. The benefits of a CI in these children are not well established. This study investigated the impact of unilateral CI on speech and language outcomes in pediatric patients with ASHL. METHODS: The retrospective chart review identified pediatric patients who underwent cochlear implantation for ASHL at a tertiary single center institution between 2014 and 2017. Children who underwent cochlear implantation in the poorer ear and maintained a hearing aid in the better ear were included, while children with cognitive impairment or prior cochlear nerve deficiency and auditory neuropathy were excluded. Speech and language measures were evaluated prior to implantation and at regular six-month intervals postoperatively. Ear specific Audiometry was evaluated at every visit and varied developmentally appropriate speech recognition tasks, including questionnaires, closed-set, and open-set measures, accounted for advancing childhood milestones. Specific measures of speech articulation, expressive and receptive language, and vocabulary were assessed including: Goldman Fristoe Test of Articulation (GFTA-3), Clinical Evaluation of Language Fundamentals (CELF-P2 or CELF-5), Receptive One-Word Picture Vocabulary Test (ROWPVT) and Expressive One Word Picture Vocabulary Test (EOWPVT). The mean difference and standard deviation of speech and language outcomes at preoperative and postoperative evaluations were calculated. The change in outcomes were further assessed over each post-operative time point. RESULTS: Twenty-six children with asymmetric sensorineural hearing loss were included in the analysis, with 11 (42%) having bilateral enlarged vestibular aqueducts (EVA). At time of CI, unaided mean Pure Tone Average (PTA-4) for the better ear was 62Db HL, and worse ear was 92Db HL. There was an improvement in speech recognition in the implanted ear as expected. All preoperative speech and language evaluations were conducted within 7 months of cochlear implantation. Twenty-three patients had at least 1 postoperative re-evaluation. Fourteen children had preoperative and postoperative assessments with the same tool, with 13 patients (93%) showing improvement in at least 1 domain. For patients with repeated assessment within 12 months of surgery, we observed an average improvement in standard scores of: GFTA-3 (+11.2), CELF-P2 Core Language (+10.3), CELF-5 Core Language (+7.0), ROWPVT (+2.8) and EOWPVT (+4.5). Individual results are described. CONCLUSION: Improvement in speech and language measures can be demonstrated in children undergoing unilateral cochlear implantation for asymmetric sensorineural hearing losses. These children, who are not typical CI candidates, can benefit from a CI in the poorer ear.

Recognition and Management of Nonaccidental Esophageal Perforation.

Nonaccidental trauma is a common pediatric concern that often goes unrecognized. Although most patients present with bruising, burns, fractures, and head trauma, it is critical that physicians be able to diagnose and treat atypical presentations such as pharyngeal and esophageal trauma. In this report, we describe the presentation and management of a 5-week-old girl with an inflicted esophageal perforation.

Hospital-Acquired Bloodstream Infections in Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 Infection (Coronavirus Disease 2019): Association With Immunosuppressive Therapies.

BACKGROUND: Immunosuppressive therapies proposed for Coronavirus disease 2019 (COVID-19) management may predispose to secondary infections. We evaluated the association of immunosuppressive therapies with bloodstream-infections (BSIs) in hospitalized COVID-19 patients. METHODS: This was an institutional review board-approved retrospective, multicenter, cohort study of adults hospitalized with COVID-19 over a 5-month period. We obtained clinical, microbiologic and laboratory data from electronic medical records. Propensity-score-matching helped create balanced exposure groups. Demographic characteristics were compared across outcome groups (BSI/no BSI) using two-sample t-test and Chi-Square test for continuous and categorical variables respectively, while immunosuppressive therapy use was compared using McNemar's test. Conditional logistic regression helped assess the association between immunosuppressive therapies and BSIs. RESULTS: 13,007 patients were originally included, with propensity-score-matching producing a sample of 6,520 patients. 3.74% and 3.97% were diagnosed with clinically significant BSIs in the original and propensity-score-matched populations respectively. COVID-19 patients with BSIs had significantly longer hospitalizations, higher intensive care unit admission and mortality rates compared to those without BSIs. On univariable analysis, combinations of corticosteroids/anakinra [odds-ratio (OR) 2.00, 95% confidence intervals (C.I.) 1.05-3.80, P value.0342] and corticosteroids/tocilizumab [OR 2.13, 95% C.I. 1.16-3.94, P value .0155] were significantly associated with BSIs. On multivariable analysis (adjusting for confounders), combination corticosteroids/tocilizumab were significantly associated with any BSI [OR 1.97, 95% C.I. 1.04-3.73, P value.0386] and with bacterial BSIs [OR 2.13, 95% C.I. 1.12-4.05, p-value 0.0217]. CONCLUSIONS: Combination immunosuppressive therapies were significantly associated with BSI occurrence in COVID-19 patients; their use warrants increased BSI surveillance. Further studies are needed to establish their causative role.

Early pediatric Cochlear implantation: An update.

The criteria and candidacy for pediatric cochlear implantation (CI) has significantly transformed over the past few decades and continues to evolve with technological advancements, and recognition of benefit in more diverse populations. Prolonged auditory deprivation among patients with profound sensorineural hearing loss has been shown to cause widespread degeneration in the central auditory system. Thus, there is increasing evidence advocating for earlier implantation within a critical neuroplastic window. However, there is a lack of consensus on this optimal age of implantation. Historically, there were concerns regarding surgical feasibility and safety, anesthesia risk, and logistical considerations in very young infants <12 months. Recent literature has investigated surgical safety and anesthesia risk as well speech and language outcomes with early implantation, resulting in the long-awaited reduction in approved age by the FDA (<9 months for certain devices). This article reviews logistical considerations, surgical safety, anesthesia risk, and language developmental outcomes associated with early CI (<12 months).

Cooling Blankets in Hospitalized Patients: Time to Reevaluate.

BACKGROUND: The therapeutic benefits and rationale for treating fevers with external cooling methods remain unclear. We aimed to describe the clinical settings in which cooling blankets (CBs) are used. DESIGN: We conducted a retrospective chart review of CB use in adult patients admitted to our tertiary care center over a one-year period. We measured how they are used and correlations between clinical variables and their duration of use. RESULTS: 561 patients were included in our study. The mean highest temperature during hospitalization was 39.35 °C (SD, 0.67). Shivering occurred in 176 patients (31.4%) while on a CB although 303 patients (54%) had no data regarding shivering. Discontinuation of CBs was recorded in only 177 (30.5%) cases. Among these, the median duration of use was 33.37 h (IQR: 18.13-80.38) while the median duration of fever was 22.13 h (IQR 6.67-51.98). Duration of CB use was highly correlated with fever duration (Spearman's rho, 0.771, p < .001), moderately with length of stay (LOS) (rho, 0.425, p < .001), LOS after CB initiation (rho, 0.475, p < .001) and antipyretic use (rho, 0.506, p < .001). No other statistically significant correlations were observed. CONCLUSION: Documentation of CB use including temperature set points, time of discontinuation and duration in EMRs was poor. We could not establish benefits of CB use in this study but observed that almost a third of patients developed adverse effects in the form of shivering. Thus, adverse effects of CB use may outweigh potential benefits. Their use should be reevaluated and institutional protocols developed for their use.

An early experience on the effect of solid organ transplant status on hospitalized COVID-19 patients.

We compared the outcome of COVID-19 in immunosuppressed solid organ transplant (SOT) patients to a transplant naïve population. In total, 10 356 adult hospital admissions for COVID-19 from March 1, 2020 to April 27, 2020 were analyzed. Data were collected on demographics, baseline clinical conditions, medications, immunosuppression, and COVID-19 course. Primary outcome was combined death or mechanical ventilation. We assessed the association between primary outcome and prognostic variables using bivariate and multivariate regression models. We also compared the primary endpoint in SOT patients to an age, gender, and comorbidity-matched control group. Bivariate analysis found transplant status, age, gender, race/ethnicity, body mass index, diabetes, hypertension, cardiovascular disease, COPD, and GFR <60 mL/min/1.73 m2 to be significant predictors of combined death or mechanical ventilation. After multivariate logistic regression analysis, SOT status had a trend toward significance (odds ratio [OR] 1.29; 95% CI 0.99-1.69, p = .06). Compared to an age, gender, and comorbidity-matched control group, SOT patients had a higher combined risk of death or mechanical ventilation (OR 1.34; 95% CI 1.03-1.74, p = .027).

A Retrospective Study Analyzing the Lack of Symptom Benefit With Antimicrobials at the End of Life.

BACKGROUND: Infections are common in terminally ill patients (pts), and although antibiotics are frequently prescribed, their benefit for symptom relief is not clear. Antimicrobials at the end of life (EOL) may increase the risk of antimicrobial resistance and Clostrioides difficile infection. Our aim was to determine the frequency of symptom occurrence at the EOL when comparing pts who did or did not receive antibiotics (AB+ or AB-). METHODS: We reviewed electronic medical records of pts admitted to a palliative care unit of a quarternary care hospital between 01/09/2017 and 07/16/2017 and assessed antimicrobial use in the last 14 days of life. Differences in demographics and symptom control between AB+ and AB- pts were analyzed using chi-square analyses; p-values were computed using Mann-Whitney tests. RESULTS: Of a total of 133 pts included, 90 (68%) received antimicrobials (AB+). The indication for antibiotics was documented in only 12% of pts. The AB+ and AB- groups were similar with respect to demographics, including sex, and Charleston Comorbidity Index except for age (p = 0.01) and race (p = 0.03). Documented infections were similar between AB+ and AB- groups, except urinary tract infections. No statistically significant differences were noted in documented symptoms including pain, dyspnea, fever, lethargy, and alteration of mental state or length of stay. CONCLUSION: Our study did not show differences in frequencies of documented symptoms with use of antimicrobials at EOL. Antimicrobial stewardship programs and further research can help with developing EOL care antimicrobial guidelines supporting patients and providers through shared decision-making.

Applications of Electrospinning for Tissue Engineering in Otolaryngology.

OBJECTIVE: In tissue engineering, biomaterials create a 3D scaffold for cell-to-cell adhesion, proliferation and tissue formation. Because of their similarity to extracellular matrix and architectural adaptability, nanofibers are of particular interest in tissue engineering. Electrospinning is a well-documented technique for nanofiber production for tissue engineering scaffolds. Here we present literature on the applications of electrospinning in the field of otolaryngology. REVIEW METHODS: A PubMed database search was performed to isolate articles published about applications of electrospun nanofibers for tissue engineering in otolaryngology. Study design, size, material tested, site of application within the head and neck, and outcomes were obtained for each study. RESULTS: Almost all data on electrospinning in otolaryngology was published in the last 6 years (84%), highlighting its novelty. A total of 25 pre-clinical studies were identified: 9 in vitro studies, 5 in vivo animal studies, and 11 combination studies. Sites of application included: tracheal reconstruction (n = 16), tympanic membrane repair (n = 3), cranial nerve regeneration (n = 3), mastoid osteogenesis (n = 1) and ear/nose chondrogenesis (n = 2). IMPLICATIONS FOR PRACTICE: Tissue engineering is a burgeoning field, with recent innovative applications in the field of otolaryngology. Electrospun nanofibers specifically have relevant applications in the field of otolaryngology, due in part to their similarity to native extracellular matrix, with emerging areas of interest being tympanic membrane repair, cranial nerve regeneration and tracheal reconstruction.

The Longitudinal Immune Response to Coronavirus Disease 2019: Chasing the Cytokine Storm.

The clinical progression of the severe acute respiratory syndrome coronavirus 2 infection, coronavirus 2019 (COVID-19), to critical illness is associated with an exaggerated immune response, leading to magnified inflammation termed the "cytokine storm." This response is thought to contribute to the pathogenicity of severe COVID-19. There is an initial weak interferon response and macrophage activation that results in delayed neutrophil recruitment leading to impeded viral clearance. This causes prolonged immune stimulation and the release of proinflammatory cytokines. Elevated inflammatory markers in COVID-19 (e.g., d-dimer, C-reactive protein, lactate dehydrogenase, ferritin, and interleukin-6) are reminiscent of the cytokine storm seen in severe hyperinflammatory macrophage disorders. The dysfunctional immune response in COVID-19 also includes lymphopenia, reduced T cells, reduced natural killer cell maturation, and unmitigated plasmablast proliferation causing aberrant IgG levels. The progression to severe disease is accompanied by endotheliopathy, immunothrombosis, and hypercoagulability. Thus, both parts of the immune system-innate and adaptive-play a significant role in the cytokine storm, multiorgan dysfunction, and coagulopathy. This review highlights the importance of understanding the immunologic mechanisms of COVID-19 as they inform the clinical presentation and advise potential therapeutic targets.

Segmentation of Temporal Bone Anatomy for Patient-Specific Virtual Reality Simulation.

OBJECTIVES: Virtual reality (VR) simulation for patient-specific pre-surgical planning and rehearsal requires accurate segmentation of key surgical landmark structures such as the facial nerve, ossicles, and cochlea. The aim of this study was to explore different approaches to segmentation of temporal bone surgical anatomy for patient-specific VR simulation. METHODS: De-identified, clinical computed tomography imaging of 9 pediatric patients aged 3 months to 12 years were obtained retrospectively. The patients represented normal anatomy and key structures were manually segmented using open source software. The OTOPLAN (CAScination AG, Bern, Switzerland) otological planning software was used for guided segmentation. An atlas-based algorithm was used for computerized, automated segmentation. Experience with the different approaches as well as time and resulting models were compared. RESULTS: Manual segmentation was time consuming but also the most flexible. The OTOPLAN software is not designed specifically for our purpose and therefore the number of structures that can be segmented is limited, there was some user-to-user variation as well as volume differences compared with manual segmentation. The atlas-based automated segmentation potentially allows a full range of structures to be segmented and produces segmentations comparable to those of manual segmentation with a processing time that is acceptable because of the minimal user interaction. CONCLUSION: Segmentation is fundamental for patient-specific VR simulation for pre-surgical planning and rehearsal in temporal bone surgery. The automated segmentation algorithm currently offers the most flexible and feasible approach and should be implemented. Further research is needed in relation to cases of abnormal anatomy. LEVEL OF EVIDENCE: 4.

Comparative Survival Analysis of Immunomodulatory Therapy for Coronavirus Disease 2019 Cytokine Storm.

BACKGROUND: Cytokine storm is a marker of coronavirus disease 2019 (COVID-19) illness severity and increased mortality. Immunomodulatory treatments have been repurposed to improve mortality outcomes. RESEARCH QUESTION: Do immunomodulatory therapies improve survival in patients with COVID-19 cytokine storm (CCS)? STUDY DESIGN AND METHODS: We conducted a retrospective analysis of electronic health records across the Northwell Health system. COVID-19 patients hospitalized between March 1, 2020, and April 24, 2020, were included. CCS was defined by inflammatory markers: ferritin, > 700 ng/mL; C-reactive protein (CRP), > 30 mg/dL; or lactate dehydrogenase (LDH), > 300 U/L. Patients were subdivided into six groups: no immunomodulatory treatment (standard of care) and five groups that received either corticosteroids, anti-IL-6 antibody (tocilizumab), or anti-IL-1 therapy (anakinra) alone or in combination with corticosteroids. The primary outcome was hospital mortality. RESULTS: Five thousand seven hundred seventy-six patients met the inclusion criteria. The most common comorbidities were hypertension (44%-59%), diabetes (32%-46%), and cardiovascular disease (5%-14%). Patients most frequently met criteria with high LDH (76.2%) alone or in combination, followed by ferritin (63.2%) and CRP (8.4%). More than 80% of patients showed an elevated D-dimer. Patients treated with corticosteroids and tocilizumab combination showed lower mortality compared with patients receiving standard-of-care (SoC) treatment (hazard ratio [HR], 0.44; 95% CI, 0.35-0.55; P < .0001) and with patients treated with corticosteroids alone (HR, 0.66; 95% CI, 0.53-0.83; P = .004) or in combination with anakinra (HR, 0.64; 95% CI, 0.50-0.81; P = .003). Corticosteroids when administered alone (HR, 0.66; 95% CI, 0.57-0.76; P < .0001) or in combination with tocilizumab (HR, 0.43; 95% CI, 0.35-0.55; P < .0001) or anakinra (HR, 0.68; 95% CI, 0.57-0.81; P < .0001) improved hospital survival compared with SoC treatment. INTERPRETATION: The combination of corticosteroids with tocilizumab showed superior survival outcome when compared with SoC treatment as well as treatment with corticosteroids alone or in combination with anakinra. Furthermore, corticosteroid use either alone or in combination with tocilizumab or anakinra was associated with reduced hospital mortality for patients with CCS compared with patients receiving SoC treatment.

Electrocochleography Observations in a Series of Cochlear Implant Electrode Tip Fold-Overs.

OBJECTIVE: Tip fold-over is a rare but serious complication of cochlear implant (CI) surgery. The purpose of this study was to present intraoperative electrocochleography (ECochG) observations in a series of CI electrode tip fold-overs. PATIENTS: Five pediatric subjects undergoing CI surgery through a round window (RW) approach with a perimodiolar electrode array, who were diagnosed with either auditory neuropathy spectrum disorder or enlarged vestibular aqueduct. INTERVENTIONS: Intraoperative RW ECochG during CI surgery: tone burst stimuli were presented from 95 to 110 dB SPL. MAIN OUTCOME MEASURES: Magnitude and phase characteristics of ECochG responses obtained intraoperatively before and immediately after electrode insertion were examined for patients with and without tip fold-over. RESULTS: Three subjects presented with tip fold-over and two formed the control group. Among fold-over cases, one participant exhibited an inversion in the starting phase of the cochlear microphonic response and a decrease in spectral magnitude from pre- to postinsertion. Both subjects who did not exhibit a change in phase had an increase in the ECochG-total response (ECochG-TR) magnitude. No case in the control group exhibited a change in starting phase. In regard to the ECochG-TR, all controls showed a decrease in the magnitude. CONCLUSIONS: Despite the small number of patients, heterogeneous ECochG response patterns were observed within the fold-over group. Though these results are not conclusive, they can serve as a framework to begin to understand ECochG's utility in detecting intraoperative tip fold-over.

Timing of newborn hearing screening in the neonatal intensive care unit: implications for targeted screening for congenital cytomegalovirus infection.

OBJECTIVE: To determine when infants in the neonatal intensive care unit (NICU) have the first hearing screen performed, and thus inform targeted testing for cytomegalovirus (CMV)-related hearing loss. STUDY DESIGN: Retrospective review of electronic health records of infants admitted to a Level 4 outborn NICU and had a first hearing screen performed from 8/2016-8/2018. RESULT: Among 1498 infants, 546 (36%) had a first hearing screen performed at age >21 days when a positive CMV PCR test cannot distinguish congenital from postnatal CMV acquisition. While most infants tested at >21 days of age were <34 weeks' gestational age (71%), 18% (n = 100) and 11% (n = 59) were ≥34 and ≥37 weeks' gestation, respectively. CONCLUSION: Targeted CMV testing for failed hearing screen in the NICU is problematic as 36% of infants did not have a hearing screen performed before 21 days of age, supporting the need for CMV screening at NICU admission.

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.

Importance: Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown. Objective: To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment. Design, Setting, and Participants: Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020. Interventions: Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d. Main Outcomes and Measures: The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group. Results: Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care. Conclusions and Relevance: Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT04292730.

The otolaryngologist's and anesthesiologist's collaborative role in a pandemic: A large quaternary pediatric center's experience with COVID-19 preparation and simulation.

There has been a rapid global spread of a novel coronavirus, the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which originated in Wuhan China in late 2019. A serious threat of nosocomial spread exists and as such, there is a critical necessity for well-planned and rehearsed processes during the care of the COVID-19 positive and suspected patient to minimize transmission and risk to healthcare providers and other patients. Because of the aerosolization inherent in airway management, the pediatric otolaryngologist and anesthesiologist should be intimately familiar with strategies to mitigate the high-risk periods of viral contamination that are posed to the environment and healthcare personnel during tracheal intubation and extubation procedures. Since both the pediatric otolaryngologist and anesthesiologist are directly involved in emergency airway interventions, both specialties impact the safety of caring for COVID-19 patients and are a part of overall hospital pandemic preparedness. We describe our institutional approach to COVID-19 perioperative pandemic planning at a large quaternary pediatric hospital including operating room management and remote airway management. We outline our processes for the safe and effective care of these patients with emphasis on simulation and pathways necessary to protect healthcare workers and other personnel from exposure while still providing safe, effective, and rapid care.