scholarly journals Implementation of SARS-CoV-2 monoclonal antibody infusion sites at three medical centers in the United States: Strengths and challenges assessment to inform COVID-19 pandemic and future public health emergency use

Author(s):  
Anastasia S. Lambrou ◽  
John T. Redd ◽  
Miles A. Stewart ◽  
Kaitlin Rainwater-Lovett ◽  
Jonathan K. Thornhill ◽  
...  

Abstract Monoclonal antibody therapeutics to treat COVID-19 have been authorized by the U.S. Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from three sites at medical centers in the U.S. supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient SARS-CoV-2 positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

2021 ◽  
Author(s):  
Anastasia S Lambrou ◽  
John T Redd ◽  
Miles A Stewart ◽  
Kaitlin Rainwater-Lovett ◽  
Jonathan K Thornhill ◽  
...  

Background: The COVID-19 pandemic caught the globe unprepared without targeted medical countermeasures, such as therapeutics, to target the emerging SARS-CoV-2 virus. However, in recent months multiple monoclonal antibody therapeutics to treat COVID-19 have been authorized by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). Despite these authorizations and promising clinical trial efficacy results, monoclonal antibody therapies are currently underutilized as a treatment for COVID-19 across the U.S. Many barriers exist when deploying a new infused therapeutic during an ongoing pandemic with limited resources and staffing, and it is critical to better understand the process and site requirements of incorporating monoclonal antibody infusions into pandemic response activities. Methods: We examined the monoclonal antibody infusion site process components, resources, and requirements during the COVID-19 pandemic using data from three initial infusion sites at medical centers in the U.S. supported by the National Disaster Medical System. A descriptive analysis was conducted using process assessment metrics to inform recommendations to strengthen monoclonal antibody infusion site implementation. Results: The monoclonal antibody infusion sites varied in physical environment and staffing models due to state polices, infection control mechanisms, and underlying medical system structure, but exhibited a common process workflow. Sites operationalized an infusion process staffing model with at least two nurses per ten infusion patients. Monoclonal antibody implementation success factors included tailoring the infusion process to the patient community, strong engagement with local medical providers, batch preparing the therapy before patient arrival, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges stemmed from confirming patient SARS-CoV-2 positivity, strained staff, scheduling needs, and coordination with the pharmacy for therapy preparation. Conclusions: Infusion site processes are most effective when integrated into the pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources. As the pandemic and policy tools such as EUAs evolve, monoclonal antibody infusion processes must also remain adaptable, as practice changes directly affect resources, staffing, timing, and workflows. Future use may be aided by incorporating innovative emergency deployment techniques, such as vehicle and home-based therapy administration, and by developing drug delivery mechanisms that alleviate the need for observed intravenous infusions by medically-accredited staff.


2018 ◽  
Vol 50 (3) ◽  
pp. 165-176 ◽  
Author(s):  
Ethan M. Bernick ◽  
Brianne Heidbreder

This research examines the position of county clerk, where women are numerically disproportionately over-represented. Using data collected from the National Association of Counties and the U.S. Census Bureau, the models estimate the correlation between the county clerk’s sex and county-level demographic, social, and political factors with maximum likelihood logit estimates. This research suggests that while women are better represented in the office of county clerk across the United States, when compared to other elective offices, this representation may be because this office is not seen as attractive to men and its responsibilities fit within the construct of traditional gender norms.


Author(s):  
Kenneth A. Couch

Employment tenure, job turnover and returns to general and specific skills are examined for male workers in Germany and the United States using data from the German Socio-Economic Panel and the Panel Study of Income Dynamics.  Employment in Germany is characterized by longer duration and less frequent turnover than in the United States.  Returns to experience and tenure are lower in Germany than in the U.S.; however, peak earnings occur later.  This delayed peak in the employment-earnings profile provides an incentive for German workers to remain longer with their employers and change jobs less frequently.


Author(s):  
Alexander A. Kaurov ◽  
Vyacheslav Bazhenov ◽  
Mark SubbaRao

The COVID-19 global pandemic unprecedently disturbed the education system in the United States and lead to the closure of all planetariums that were providing immersive science communication. This situation motivates us to examine how accessible the planetarium facilities were before the pandemic. We investigate the most important socioeconomic and geographical factors that affect the planetarium accessibility using the U.S. Census Bureau data and the commute time to the nearest planetarium for each ZIP Code Tabulated Area. We show the magnitude of the effect of permanent closure of a fraction of planetariums. Our study can be informative for strategizing the pandemic response.


1988 ◽  
Vol 82 (4) ◽  
pp. 1109-1127 ◽  
Author(s):  
Gregory A. Caldeira ◽  
John R. Wright

Participation as amicus curiae has long been an important tactic of organized interests in litigation before the U.S. Supreme Court. We analyze amicus curiae briefs filed before the decision on certiorari and assess their impact on the Court's selection of a plenary docket. We hypothesize that one or more briefs advocating or opposing certiorari increase the likelihood of its being granted. We test this hypothesis using data from the United States Reports and Briefs and Records of the United States Supreme Court for the 1982 term. The statistical analysis demonstrates that the presence of amicus curiae briefs filed prior to the decision on certiorari significantly and positively increases the chances of the justices' binding of a case over for full treatment—even after we take into account the full array of variables other scholars have hypothesized or shown to be substantial influences on the decision to grant or deny.


Author(s):  
Scott Carter

This chapter offers a descriptive analysis of the demographic presence and economic activity of the Hispanic population in six core Heartland states: Arkansas, Iowa, Kansas, Missouri, Nebraska, and Oklahoma; hereafter referred to collectively as the Heartland 6 (HL6). It gives an overall view of the underlying trends in Hispanic demography, productivity, employment, and other relevant socioeconomic variables from 2000–2007. It shows that the HL6 experienced increased rates of growth in its Hispanic population, a trend consistent with evidence reported in the recent “new destinations” literature. At the same time, traditional growth states vis-à-vis Hispanic presence report decreasing trends in their growth rate. This represents a diffusion, or convergence, of Latin American migrations throughout the United States. Economic performance, income distribution, employment, and the age-gender profile are also descriptively presented.


2020 ◽  
Vol 21 (10) ◽  
pp. 2391-2400
Author(s):  
Michael S. Buban ◽  
Temple R. Lee ◽  
C. Bruce Baker

AbstractSince drought and excessive rainfall can have significant socioeconomic impacts, it is important to have accurate high-resolution gridded datasets that can help improve analysis and forecasting of these conditions. One such widely used dataset is the Parameter-Elevation Regressions on Independent Slopes Model (PRISM). PRISM uses a digital elevation model (DEM) to obtain gridded elevation analyses and then uses a regression analysis along with approximately 15 000 surface precipitation measurements to produce a 4-km resolution daily precipitation product over the conterminous United States. The U.S. Climate Reference Network (USCRN) consists of 114 stations that take highly accurate meteorological measurements across all regions of the United States. A comparison between the USCRN and PRISM was performed using data from 2006 to 2018. There were good comparisons between the two datasets across nearly all seasons and regions; most mean daily differences were <1 mm, with most absolute daily differences ~5 mm. The most general characteristics were for a net dry bias in the PRISM data in the Southwest and a net moist bias in the southern United States. Verifying the PRISM dataset provides us with confidence it can be used with estimates of evapotranspiration, high-resolution gridded soil properties, and vegetation datasets to produce a daily gridded soil moisture product for operational use in the analyses and prediction of drought and excessive soil moisture conditions.


2006 ◽  
Vol 69 (1) ◽  
pp. 233-237 ◽  
Author(s):  
VIBHA VIJ ◽  
ELIZABETH AILES ◽  
CECILIA WOLYNIAK ◽  
FREDERICK J. ANGULO ◽  
KARL C. KLONTZ

From 1980 to 2000, the annual per capita consumption of spices in the United States increased by 60% (from 1.0 to 1.6 kg per person per year). Although spices are known to harbor various molds, fungi, and bacteria, relatively few reports have documented this group of foods as the cause of human illness. In recent years, however, the U.S. Food and Drug Administration (FDA) has noted an increased number of recalls of dried spices due to bacterial contamination. Accordingly, we reviewed spice recalls that took place in the United States from fiscal years 1970 to 2003. During the study period, the FDA monitored 21 recalls involving 12 spice types contaminated with bacterial pathogens; in all but one instance, the recalled spices contained Salmonella. Paprika was the spice most often involved in the recalls. A wide variety of countries were the source of the recalled spices. Using data from the Centers for Disease Control and Prevention National Salmonella Surveillance System, we were unable to discern any increases in the reported incidence of laboratory-confirmed salmonellosis in states that received spices contaminated with selected rare Salmonella serotypes. A variety of effective methods exist to disinfect spices, procedures that have attained increased importance given the frequent use of spices in ready-to-eat foods and the potential for contaminated spices to cause widespread outbreaks.


2018 ◽  
Vol 10 (1) ◽  
Author(s):  
Judy Akkina ◽  
Leah Estberg

ObjectiveThis study characterizes the epidemiology of suspected pesticide poisoning in livestock in the United States (U.S.) and Canada using data from calls to the American Society for the Prevention of Cruelty to Animals (ASPCA) Animal Poison Control Center (APCC).IntroductionPesticides are used in agriculture and in the home to control pests such as insects, weeds, fungi and rodents. Pesticide poisoning in animals is usually due to misuse or accidental exposure1. Information on poisonings in livestock in North America is largely lacking2. Examples of hotlines in the U.S. for animal poisoning consultations include the APCC ($65.00 fee) and the Pet Poison Helpline (PPH) ($59.00 fee). The APCC fields calls 24 hours/day, 7 days/week about animal poisonings from the U.S., its territories and Canada. Using data from almost 4 years of APCC calls we describe the occurrence, category and class of pesticides involved, and outcomes of suspected pesticide exposures in livestock. This information is useful to raise awareness, encourage the proper use of pesticides and identify specific pesticides with negative impact on livestock health.MethodsAPHIS contracts with the APCC to receive de-identified data weekly on livestock calls for the purpose of conducting surveillance. This retrospective study used data from all calls concerning bovine, camelid, caprine, equine, ovine, porcine and poultry species from 10/1/2013 to 9/2/2017, where the caller reported suspected pesticide exposure. There were 1,025 calls regarding 3,028 animals meeting this criteria, representing 52% of all livestock calls with any type of toxic exposure. Caller type was 80% animal owners, 10% veterinarian or veterinary staff, and 10% other types. Most callers (92%) provided their zip code, with 96% of calls from the U.S. and 4% from Canada. Variables used for descriptive analysis were: species; APCC staff assessment that illness was due to pesticide exposure; severity of illness; clinical signs; first, second and third ingredients of the pesticide, and pesticide ingredient class (e.g. pyrethrin). Pesticides were grouped based on the first active ingredient into fungicide, herbicide, insecticide, and rodenticide categories.ResultsThe proportion of calls by species was equine (33%), poultry (26%), bovine (25%), caprine (8%), porcine (6%), ovine (2%), and camelid (0.5%). Some animals were exposed to >1 pesticide product and some pesticide products had >1 ingredient class. The pesticide category with the highest number of exposed animals was insecticides (2,151), followed by herbicides (839), rodenticides (765) and fungicides (286). The treemap below illustrates the number and proportions of animals exposed to the 4 pesticide categories and the top 3 pesticide classes within each category based on the first active ingredient. For all pesticide exposures in all species, no illness was reported in 68% of animals. According to assessment by APCC staff, only 35% (333) of animals showing clinical signs were considered with confidence (medium or high likelihood) to be due to pesticide exposure. For these 333 animals, severity of illness was mild for 80% (266 animals), moderate for 18% (61 animals), major for 1% (3 animals) and caused death in 1% (3 animals). Among animals with confidence that clinical signs were due to pesticide exposure the most frequent syndrome was dermatologic.ConclusionsSuspected pesticide exposure was the most frequent reason a call concerning livestock was made to the APCC. Callers reported that most animals showed no illness, and major illness or death was rare. Livestock were most frequently exposed to the insecticide category, and 46% of the animals with exposure to insecticides were exposed to the pyrethrin class. This is consistent with the phasing out of organophosphate insecticides for residential use since 2000 and the increasing use of pyrethrin insecticides3, which are considered less toxic. Limitations of this study include: 1) data from only one major animal poison control hotline was available for analysis and people may call their veterinarian directly or use the internet 2) calls regarding specific ingredients may be over represented due to corporate client relationships with the APCC 3) illness may have occurred after the call was made, therefore the proportion of animals with illness following suspected exposure may be an underestimate.References1. Wang Y, Kruzik P, Helsber A, Helsberg I, Rausch W. (2006) Pesticide poisoning in domestic animals and livestock in Austria: A 6 year retrospective study. Forensic Science International 169:157-160.2. Gwaltney-Brant SM. (2012). Epidemiology of Animal Poisonings in the United States. In: Gupta RC (Ed.), Veterinary Toxicology: Basic and Clinical Principles. Elsevier, Second ed: 80-87.3. Power LE, Sudakin DL. Pyrethrin and pyrethroid exposures in the United States: A longitudinal analysis of incidents reported to Poison Centers. (2007) J of Medical Toxicology. 3(3):94-99. 


2020 ◽  
Author(s):  
Sean L Wu ◽  
Andrew Mertens ◽  
Yoshika S Crider ◽  
Anna Nguyen ◽  
Nolan N Pokpongkiat ◽  
...  

Accurate estimates of the burden of SARS-CoV-2 infection are critical to informing pandemic response. Current confirmed COVID-19 case counts in the U.S. do not capture the total burden of the pandemic because testing has been primarily restricted to individuals with moderate to severe symptoms due to limited test availability. Using a semi-Bayesian probabilistic bias analysis to account for incomplete testing and imperfect diagnostic accuracy, we estimated 6,275,072 cumulative infections compared to 721,245 confirmed cases (1.9% vs. 0.2% of the population) as of April 18, 2020. Accounting for uncertainty, the number of infections was 3 to 20 times higher than the number of confirmed cases. 86% (simulation interval: 64-99%) of this difference was due to incomplete testing, while 14% (0.3-36%) was due to imperfect test accuracy. Estimates of SARS-CoV-2 infections that transparently account for testing practices and diagnostic accuracy reveal that the pandemic is larger than confirmed case counts suggest.


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