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Purpose: Preliminary data indicate that pregnant women infected with COVID-19 are at increased risk of pregnancy complications (US Centers for Disease Control and Prevention, October 2022). Information on the real-world safety of COVID-19 vaccination in pregnancy is essential. We sought to describe preliminary results for pregnancy status among pregnancy registry participants enrolled in an ongoing safety study of the Pfizer-BioNTech COVID-19 vaccine to date. Method(s): This study uses data from the Organization of Teratology Information Specialists (OTIS) Pregnancy Registry as part of the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) which enrolls pregnant women residing in the US or Canada. Data are captured through maternal interviews and the ion of medical records. The study population for this descriptive analysis includes Registry participants who met eligibility criteria on or after December 11, 2020, the date the US Food and Drug Administration granted emergency-use authorization for the Pfizer-BioNTech vaccine. The target sample size is 1,100 pregnant women who received any dose of the Pfizer-BioNTech vaccine from 30 days prior to the last menstrual period through the end of pregnancy, and 900 comparison women who received no COVID-19 vaccine in pregnancy. Result(s): Among pregnant women participating in the Registry between 11 December 2020 and 22 July 2022, 1,100/1,100 participants (100.0% of the target sample) were enrolled as part of the Pfizer-BioNTech COVID-19 vaccine exposure cohort, and 635/900 participants (70.6% of the target sample) were enrolled in the comparator cohort. As of 22 July 2022, 858 (78.0%) in the vaccine exposure cohort and 313 (34.8%) in the comparator cohort had completed pregnancies. Descriptive data indicated numerically similar percentages of pregnancies ending in at least one liveborn infant, spontaneous abortions, stillbirths, and elective terminations across the exposed cohort stratified by trimester of the earliest dose of the Pfizer-BioNTech COVID-19 vaccine received in pregnancy, and overall in the unexposed comparator cohort. Conclusion(s): Preliminary data have not identified any new safety concerns thus far for pregnant women who receive the Pfizer-BioNTech COVID-19 vaccine during pregnancy. Funding(s): This study was conducted as a collaboration between the University of California San Diego and Pfizer. Pfizer is the study sponsor.
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Background: The US Food and Drug Administration under an Emergency Use Authorization approved use of Paxlovid (nirmatrelavir and ritonavir) for the treatment of mild-to-moderate COVID-19 in adults and children with a positive test for SARS-Co-2 and who are at high risk for progression to severe COVID-19. Pregnant women are at increased risk of severe complications resulting from COVID-19 infection;however, minimal data on the safety of Paxlovid in human pregnancy are available. Objective(s): The objectives of this study are to assess risks of major congenital malformations, spontaneous abortion, elective termination, stillbirth, preterm delivery, small for gestational age infants at birth, or infants who were small for age at one year in pregnancies/infants prenatally exposed to Paxlovid in pregnancy compared to individuals who did not receive this treatment. Design(s): This study involves prospective data from the Organization of Teratology Information Specialists (OTIS) Pregnancy Registry which enrolls pregnant women residing in the US or Canada and captures data through maternal interviews and ion of medical records. Result(s): Among pregnant women participating in the OTIS Pregnancy Registry as of February 1, 2023, 59 reported exposure to Paxlovid in pregnancy;25.4% exposed within 30 days prior to the last menstrual period and through the first trimester, 42.4% exposed in second trimester, and 32.2% exposed in the third trimester. As of January 2023, 17 of those enrolled have completed pregnancy outcomes. One was lost to follow-up. Of the remainder, there were no adverse pregnancy outcomes reported. Conclusion(s): Very limited data are available on this potentially beneficial treatment in pregnancy. To date, no serious signals for this exposure have been detected.
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In 2009, the Vito field was discovered in more than 4,000 ft of water approximately 150 miles offshore from New Orleans, Louisiana. The project produces from reservoirs nearly 30,000 feet below sea level. This paper provides an overview of the Hull & Mooring system, executing a minimum technical scope to produce a simplistic design. This paper is part of a Vito Project series at OTC 2023, and the other papers are listed in the references. The original Vito project execution strategy was to replicate the Shell mega-project of Appomattox. As the industry and market began to change in 2015, the project faced significant financial hurdles, and the project team decided to refresh the design concept to reduce cost and simplify. The team regrouped to propose a smaller semi-submersible Floating Production System (FPS) with a simplistic mooring design. The Topsides was designed to be lifted as a single module, with a payload of less than 10,000 st to enable competitive tendering process. The redesigned FPS concept was moored with 12 taut, chain – polyester – chain mooring line system utilizing an in-line mooring tensioner, removing the traditional mechanically complicated and space demanding "on-vessel" winch systems. Vito employed a passive hull system, with all ballasting occurring over the top without hull penetrations. There were no pump rooms within the hull as equipment is accessed from top of column, removing the need for regular hull access to maintain equipment. The hull compartmentation also followed a simple approach, containing only 12 ballast tanks to reduce fabrication cost. The hull design also included simplified ring stiffening for columns which eliminated the traditional orthogonally stiffened systems. Additionally, the structure utilized an upper column frame structure to support the topsides deck and served as a bracing for supporting columns at the top for squeeze-pry loads and bracing for supporting columns during dry tow. The simplification of the stiffening system and topsides deck support design reduced interfaces between hull and topsides and also opened up options for fabrication of topsides and hull. Key challenges included developing installation methods without traditional FPS mooring chain jacks and increasing installation options by not requiring a large installation derrick barge and enabling use of common anchor handler vessels. The project experienced fabrication delays due to COVID-19, which required creative solutions transporting the FPS from Singapore to the Gulf of Mexico. The design team © 2023, Offshore Technology Conference.
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Introduction: The respiratory tract infections (RTIs), including pneumonia, influenza and Coronavirus Disease 2019 (COVID-19), are the leading cause of hospitalization and mortality worldwide, contributing to elevated healthcare and societal costs. There is conflicting evidences about the effects of angiotensin converting enzyme inhibitor (ACEIs) or angiotensin II receptor blockers (ARBs) on the susceptibility of RTIs. Method(s): Systematic review of interventional and observational studies that reported use of ACEI or/and ARB on incidence of pneumonia or influenza or COVID-19. Searching was conducted in the databases of PubMed, Excerpta Medica Database (Embase), Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), including the Cochrane Library until April 2022, and references of retrieved relevant articles. We assessed the quality of included studies by using Cochrane Collaboration Risk of Bias tool for Randomized Controlled Trials and Newcastle-Ottawa Scale for observational studies. DerSimonian Laird random-effects meta-analysis was conducted to pool effects for the incidence of pneumonia, influenza and COVID-19. Subgroup analyses were carried according to baseline morbidities (hypertension or cardiovascular diseases, cerebrovascular diseases, chronic kidney disease (CKD) and other non-communicable diseases). Pooled estimates of odds ratios (OR) and corresponding 95% confidence intervals (95% CI) were computed, and heterogeneity among studies was assessed using Cochran's Q test and the I2 metrics, with two tailed P values. Result(s): 73 studies met the inclusion criteria, of which 38 studies assessed the odds of pneumonia, 32 studies assessed Covid-19 and 3 studies assessed influenza. The quality of included studies was moderate. Use of ACEIs was associated with a significantly reduced odds of pneumonia (23 studies: OR 0.74, 95% CI 0.64 to 0.85;I2=76.8%), of COVID-19 (24 studies: OR 0.87, 95% CI 0.82 to 0.92;I2=81.9%) and influenza (3 studies: OR 0.75, 95% CI 0.57 to 0.98, I2=97.7%), compared with control treatment. Use of ARBs was also associated with reduced odds of COVID-19 (25 studies: OR 0.90, 95% CI 0.83 to 0.97;I2=91.9%), but not with odds of pneumonia or influenza. These findings remain consistent in the community population, patients with history of cerebrovascular diseases or cardiovascular diseases, but not in those with CKD, diabetes and chronic obstructive pulmonary diseases. Conclusion(s): The current evidence favours a putative protective role of ACEIs, not ARB in odds of pneumonia, COVID-19 and influenza. Patient populations that may benefit most are those within the community, history of cerebrovascular diseases and cardiovascular diseases. No conflict of interestCopyright © 2023
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COVID-19 infections and deaths in the United States have affected racial groups differentially. Until now, there has been no analysis of the role that structural racism plays in those health outcomes. We use three models of ascending complexity to quantify the state-level impact of reporting bias, socioeconomic difference, and endogenous policy choices in a treatment model. Even after controlling for confounding factors like Black Lives Matter and other public demonstrations, multivariate regressions conclude that all three explain the phenomenon. We estimate massive avoidable costs of over 870,000 infections and 39,000 deaths due to unequal health outcomes by race. © 2021 Informa UK Limited, trading as Taylor & Francis Group.
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Background: Severe hyponatraemia can lead to serious neurological complications including coma, seizure and death. Hyponatraemia and the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) has been previously described in cases of COVID-19, however there have been few reports post vaccination. We describe a case of severe hyponatraemia post second Pfizer BNT162b2 mRNA vaccination against COVID-19. Case presentation: A 48-year-old previously well woman presented to the emergency department with severe headaches and confusion one day after she received her second Pfizer COVID-19 vaccination. She reported no more than 2.5 L fluid intake. Vital signs were normal. Laboratory investigation revealed serum sodium 113 mmol/L, potassium 3.4 mmol/L, urea 3.5 mmol/L and serum osmolality 266 mmol/kg. TSH, random cortisol and C-reactive protein levels were normal. She was found to be in urinary retention and developed marked polyuria post in dwelling catheter insertion. Following this she underwent spontaneous and rapid correction of serum sodium without intervention. Retrospective analysis showed an inappropriately high copeptin of 4.4 pmol/L. Conclusions: It is important to be cautioned and aware of hyponatraemia as an immediate side effect of COVID-19 vaccination. The exact mechanism is unknown and further research is required to understand the acute endocrine effects which may arise in response to COVID-19 vaccination.
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INTRODUCTION: Severe ARDS has mortality rates exceeding 45% particularly when meeting criteria for ECMO. APRV has been used for over 4 decades to improve oxygenation when failing conventional MV strategies and may reduce the need for ECMO rescue if implemented early. METHOD(S): Retrospective study of all adult patients referred for V-V ECMO evaluation at UF-Jacksonville for ARDS from 7/17 - 8/2021 including COVID-19 illness that were managed on APRV without ECMO. The EMR was used to search for the datapoints: survival to discharge, P/F ratio at time of referral and then at 1, 6, and 24 hours after initiating APRV when ECMO was not implemented, paralytic and vasopressor usage prior to and 6 hours after initiating APRV, and lactate levels at time 0, 6 hours and 24 hours after initiating APRV. RESULT(S): There were 65 consults for V-V ECMO due to ARDS that were managed on APRV without ECMO. The mean age was 40.1 years;59% men and 41% women;category of ARDS was medical in 72%, trauma in 26%, and surgical in 2%. All patients were on ARDsnet ventilation strategy when referred. The survival to discharge was 79.3% with 50% going home, 39% to rehab, and 11% to an LTAC. The mean P/F ratio at time of evaluation was 77.1;1 hour after initiating APRV it was 122.7;6 hours after initiating it was 163.8;24 hours after initiating it was 211.8 and the mean FiO2 at 24 hours was 59.2%. At time of evaluation 50.8% of patients were on paralytic infusions and 33.3% were on vasopressors while 6 hours after initiating APRV it was 0% for the former and 14.5% for the latter. Mean serum lactate was 3.1 mmol/L at time 0, then 2.6 mmol/L 6 hours after APRV was initiated, and 2.3 mmol/L 24 hours after initiating APRV. CONCLUSION(S): We had excellent success using APRV to improve severe hypoxia in patients failing on standard ventilation using ARDSnet strategy, with a survival rate without ECMO of nearly 80%. The reduction in paralytic use and vasopressor requirements likely contributed to improved pulmonary and cardiovascular function allowing the vast majority of survivors to go home directly or home after shortterm rehab stay. APRV should be considered in severe ARDS and may avoid the need for ECMO in some patients if applied before the patient is in extremis.
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INTRODUCTION: Severe ARDS has mortality rates exceeding 45% particularly when meeting criteria for ECMO;COVID-19 patients requiring MV for ARDS have even higher mortality rates. APRV has been used for over 4 decades to improve oxygenation when failing conventional MV strategies, but it was implemented in many ICUs for the 1st time during the COVID-19 pandemic. METHOD(S): Retrospective study of all adult patients referred for V-V ECMO evaluation at UF-Jacksonville due to COVID-19 induced ARDS from 6/2020 - 9/2021. The EMR was used to search for the datapoints: survival to discharge, P/F ratio at time of referral and then at 1, 6, and 24 hours after initiating APRV when ECMO was not implemented, and paralytic and vasopressor usage prior to and 6 hours after initiating APRV. RESULT(S): A total of 30 patients were referred for V-V ECMO. 20 patients (12 men, 8 women, mean age 41.4 years) were managed without ECMO utilizing APRV. The survival rate was 55% (11/20) with 91% discharged to home and 9% to rehab;five deaths were attributed to other specific causes such as: loss of airway, STEMI, myocarditis (VF) in 2 patients, and MSSA bacteremia. All patients were on ARDsnet ventilation strategy when referred. The mean P/F ratio at time of evaluation was 71.0;1 hour after initiating APRV it was 129.2;6 hours after initiating it was 135.5;24 hours after initiating it was 172.9 and the mean FiO2 at 24 hours was 67.9%. At time of evaluation 52.6% of patients were on paralytic infusions and 15.8% were on vasopressors while 6 hours after initiating APRV it was 0% for both. 10 patients required ECMO with survival rate of 30%. Six of the 10 patients went on ECMO immediately at the time of ECLS consult due to being in extremis from severe hypoxia as well as some patients also with critical respiratory acidosis. CONCLUSION(S): We had good success using APRV to improve severe hypoxia in patients failing on standard ventilation using ARDSnet strategy with a survival rate without ECMO of 55%. The reduction in paralytic use and vasopressor requirements likely contributed to >90% of survivors being able to go directly home. APRV should be considered in COVID-19 induced ARDS and may avoid the need for ECMO in some patients.
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Background: Maintenance dialysis patients' SARS-CoV-2 receptor binding spike antibody (RBD s-Ab) levels decline rapidly in the months following initial vaccination. We describe the association of RBD s-Ab levels with a subsequent diagnosis of COVID-19 and COVID-related hospitalization or death. Method(s): We identified all vaccinated adult maintenance dialysis patients at Dialysis Clinic, Inc. who were diagnosed with COVID-19 between June 20, 2021 and May 8, 2022. Descriptive analyses illustrate the association of RBD s-Ab levels assessed 7-45 days prior to COVID-19 diagnosis with COVID-related hospitalization or death. Result(s): There were 340 maintenance dialysis patients with RBD s-Ab levels assessed at a median 23 [16,40] days prior to COVID diagnosis, with mean age 65+/-13 years, 51% female, 51% White, 91% HD and vintage 4.3+/-4.3 years. While COVID-19 diagnosis and COVID-related hospitalization or death events occurred across RBD s-Ab levels (Figure), 74 of 93 (80%) COVID-related hospitalizations and 24 of 25 deaths (96%) occurred at RBD s-Ab level <500 BAU/mL Conclusion(s): Maintenance dialysis patients are at risk for serious COVID events when RBD s-Ab < 500 BAU/mL. Routine RBD s-Ab measurement informing personalized vaccination strategies to keep titers above 500 BAU/mL may benefit this high-risk population.
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Background: Preventing COVID-19 infection or its consequences through SARSCoV- 2 vaccination in maintenance dialysis patients, a high risk population, is imperative. We determined relative vaccine effectiveness (VE) of 1, 2, or 3 doses of an mRNA vaccine in preventing SARS-CoV-2 infection, hospitalization, and death. Method(s): All adult maintenance dialysis patients at Dialysis Clinic, Inc. offered an mRNA vaccine between 12/15/20 and 2/28/22 were included, with follow up time through 3/31/22. Using a multivariable logistic regression model, we calculated adjusted odds ratios (OR) for COVID-19 infection and associated hospitalization and death within 30 days during pre-Delta (12/15/20-6/19/21), Delta (6/20-12/18/21) and Omicron (12/19/21-2/28/22) periods. VE was calculated as (1-adjusted OR) x 100%. Patients were censored at infection, death, or transplantation. Result(s): The 17,309 maintenance dialysis patients included had mean age of 63+/-15 years, 58% male, 35% Black, 47% White, 87% HD and mean vintage 42+/-55 months. Across all three COVID-19 variant periods, VE increased with each successive mRNA dose received, improving protection against infection, hospitalization and death (Table). VE was highest among patients vaccinated with homologous mRNA-1273 regimens. Conclusion(s): Two or more SARS-CoV-2 mRNA vaccine doses exhibited VE protecting against COVID-19 related associated hospitalization and death in maintenance dialysis patients irrespective of variant era. At least 3 doses maximizes protection and may be necessary due to uremia-related mild to moderate immunodeficiency. (Table Presented).
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Background: Among patients receiving maintenance dialysis, seroresponse to an initial vaccine series wanes over time. Previously, we showed that additional doses elicit a substantial short-term increase in seroresponse. Here, we assess seroresponse over time in a national sample of maintenance dialysis patients. Method(s): Using retrospective clinical data, we assessed seroresponse to additional SARS-CoV-2 vaccine doses over time among maintenance dialysis patients cared for at Dialysis Clinic, Inc (DCI) facilities. Via a clinical protocol available to dialysis providers, antibodies against SARS-CoV-2 spike antigen were assessed monthly alongside routine labwork. Patients with history of COVID-19 prior to additional dose and patients who received Janssen vaccine as an additional dose were excluded. Titers after a second additional dose (i.e., for most, a fourth dose) or after COVID-19 diagnosis were excluded from analysis. Result(s): Among 1707 patients who had received an additional vaccine dose and had at least one titer level measured after the additional dose, more than 75% had a titer level at the upper limit of the assay in the first month after the additional dose. Titer levels then waned across vaccine types. By Month 6, median [IQR] titer was 68.37 [22.30, >=100] among Moderna recipients, 59.94 [39.90, 79.97] among Moderna half-dose recipients, and 71.29 [22.46, >=100] among Pfizer recipients. Conclusion(s): Among patients receiving maintenance dialysis, anti-spike IgG levels after an additional SARS-CoV-2 vaccine dose wane over time across vaccine types. These results suggest a role for routine antibody monitoring to assess possible need for further re-dosing.
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Background and Objective(s): Throughout the COVID-19 pandemic, Outpatient Physical, Occupational and Speech therapies at a large urban pediatric hospital averaged 300 to 500 appointments a week. Many appointments were via telehealth;a shift in practice model as most therapy appointments were on-site prior to the pandemic. To ensure quality of care and adapt telehealth to maximize patient/caregiver satisfaction, a quality improvement project was performed, seeking staff feedback regarding telehealth experiences to assist in modifying service delivery models. Study Design: Cross-sectional study. Study Participants & Setting: 47 of 57 therapists (36.17% PT, 25.53% OT, 38.30% SLP) responded to the survey during September 2021. Therapists completed the survey once during a 30-day time period if they provided services via telehealth. Therapists had a range of experiences providing pediatric therapy services (21.28% with 0-3 years to 25.53% with 19+ years). Patients served ranged 2 months to 74 years with diagnoses including autism and cerebral palsy. Materials/Methods: Survey responses are summarized descriptively with the most frequent responses reported using percentages. The electronic survey in Qualtrics consisted of 40 questions with multiple response options including multiple choice, free text, and rank order. The question topics included: telehealth training, contributors to success and/ or lack of success (including patient engagement, defined as behavior, motivation, ability to follow directions/structure;and caregiver engagement defined as motivation, capacity to perform therapy, ability to understand instructions from therapist), home exercise program compliance, and plan of care modifications. Result(s): 580 telehealth visits occurred during the survey time. 83.78% of therapists reported patient or caregiver engagement as the biggest contributor to a successful telehealth session and 57.89% reported the same as biggest limiting factor. There was no staff consensus on a certain patient age or diagnosis having the most or least success with telehealth. 47.50% of respondents reported the ability to see the patient in their natural environment as what they liked most about telehealth. 69.23% of therapists reported the inability to use hands on skills with the patient as what they liked least about telehealth. 92.5% of therapists reported their preferred mode of service delivery in the future would be a hybrid model of in-person and telehealth. Conclusions/Significance: Parent and patient engagement were identified as having the most impact on success or nonsuccess of a telehealth session. Providers noted telehealth pros like: seeing the patient in their natural environment, and cons like not using hands on skills during treatment. We postulate that the future of pediatric rehab will be a hybrid model of care: utilizing both hands on skills during onsite visits and telehealth intervention in the patient's natural environment to extend caregiver involvement and functionality of home programs to improve the lives of the diverse patient population we serve.
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Thinking Government examines the key roles and duties of the Canadian federal government and its public service, and the policy and program debates that revolve around these roles and duties. The fifth edition of this textbook provides students with a core awareness of major issues shaping federal policies and programs - socio-economic policy options, French-English relations, regionalism and regional policy, Canadian-American relations, immigration, environmental policy, and Indigenous relations. This book takes a close look at how prime ministers and cabinet ministers interact and discusses issues in federal, financial, and human resources management, ethics and accountability, and leadership. The new edition is revised and updated throughout and addresses the 2021 federal election and the resulting Trudeau minority government as well as the federal response to the COVID-19 pandemic. Thinking Government helps its readers to be smart citizens and knowledgeable critics of what governments do well, what they could be doing better, and why they, at times, fail to deliver effective policies and programs. © University of Toronto Press 2022. All rights reserved.
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The purpose of this study is to report the impact of COVID-19 on hand surgery fellow learning and preparedness for practice. A multi-dimensional questionnaire was distributed to current hand fellows and fellowship directors across the United States. Survey questions included fellowship location, institutional response, impact on practice, education and job search. Thirty-two hand surgery fellows and 14 fellowship directors completed the survey. Of fellows, 59% reported a greater than 75% decrease in case volume. Mean hours worked per week per fellow decreased by 52%. All fellowship directors and 94% of fellows did not expect COVID-19 to impact their ability to graduate, and nearly all fellows felt prepared to start practice after fellowship training. However, many fellows expressed concern about job opportunities. The work hours and exposure of hand surgery fellows to elective surgical cases have been adversely impacted by COVID-19. Nevertheless, current hand fellows feel prepared to enter practice. (Journal of Surgical Orthopaedic Advances 31(1):048-052, 2022).
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At Dialysis Clinic Inc., a national dialysis provider, we assessed the impact of COVID-19 on delivery of care by comparing the risk of mortality and hospitalization month-over-month over three years. Monthly rates for all-cause mortality (with Poisson regression) and hospitalization (with negative binomial regression) were calculated per 1000 patient months for in-center hemodialysis (ICHD) patients for calendar months Jan-Sept for 2018, 2019 and 2020, adjusted for age and race. The analysis was repeated with and without patients with COVID-19. During Jan-Sept 2020 there were 1,743 deaths in 15,336 non-COVID-19 patients and 204 deaths in 995 COVID-19 patients. A nonsignificant increased monthly mortality rate was observed in April 2020 [15.79 (13.83, 18.02)] relative to other months in 2018, 2019 and 2020 (Figure). Excluding patients after COVID-19 diagnosis, the April 2020 monthly death rate decreased [12.16 (10.45, 14.15)] in alignment with other months/years. During Jan-Sept 2020 there were 14,531 hospitalizations in 15,336 non-COVID-19 patients and 976 hospitalizations in 995 COVID-19 patients. There was a significant decrease in monthly hospitalization rate in April 2020 [111.39 (105.08, 118.08)] (Figure) and a further significant decrease after excluding COVID-19 patients [98.07 (92.15, 104.38)] relative to other months in 2018, 2019, and 2020. During the COVID-19 pandemic ICHD patient monthly mortality rates did not differ significantly whereas hospitalization rates did decrease significantly during the month of April 2020 Despite lower hospitalization rates, outpatient care quality was sufficiently maintained to avoid increased non-COVID marginal mortality risk.
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The optimal time to initiate research on emergencies is before they occur. However, timely initiation of high quality research may launch during an emergency under the right conditions. These include an appropriate context, clarity in scientific aims, preexisting resources, strong operational and research structures that are facile, and good governance. Here, Nebraskan rapid research efforts early during the 2020 coronavirus disease pandemic, while participating in the firstuse of U.S. federal quarantine in 50 years, are described from these aspects, as the global experience with this severe emerging infection grew apace. The experience has lessons in purpose, structure, function, and performance of research in any emergency, when facing any threat.