Category: Covid-19

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The Impact of COVID-19 on Science Education – Public Policy Institute of California

June 22, 2022

Banilower, Eric. R., P. Sean Smith, Iris R. Weiss, Kristen A. Malzahn, Kiira M. Campbell and Aaron M Weis. 2013. Report of the 2012 National Survey of Science and Mathematics Education. Horizon Research, Inc.

Berger, Marc., Ming Kuang, Laura Jerry, and Davis Freund. 2022. Impact of the Coronavirus (COVID-19) Pandemic on Public and Private Elementary and Secondary Education in the United States: Results from the 2020-21 National Teacher and Principal Survey (NCES 2022-019). U.S. Department of Education. Washington, DC: National Center for Education Statistics.

Besecker, Megan, Andrew Thomas, and Glenn Daley. 2020. Student Engagement Online during School Facilities Closures: An Analysis of L.A. Unified Secondary Students Schoology Activity from March 16 to May 22, 2020. Los Angeles Unified School District.

Burbio. 2020. K-12 School Opening Tracker.

Burbio. 2021. K-12 School Opening Tracker.

California Department of Education. 2014. Next Generation Science Standards Systems Implementation Plan for California.

California Department of Education. 2016. 2016 Science Framework Curriculum Frameworks.

California Department of Education. 2022. Data Quest.

California State Board of Education. 2013. Next Generation Science Standards for California Public Schools, Kindergarten through Grade Twelve. California State Board of Education.

Carver-Thomas, Desiree, Dion Burns, Melanie Leung, and Naomi Ondrasek. 2022. Teacher Shortages during the Pandemic: How California Districts Are Responding. Learning Policy Institute.

Clewell, Beatriz Chu, Clemencia Cosentino de Cohen, Patricia B. Campbell, and Lesley Perlman. 2005. Review of Evaluation Studies of Mathematics and Science Curricula and Professional Development Models. Urban Institute.

Education Development Center. 2018. What Parents Talk About when They Talk About Learning: A National Survey About Young Children and Science.

Gao, Niu, Sara Adan, Luna Lopes, and Grace Lee. 2018. Implementing the Next Generation Science Standards: Early Evidence from California. Public Policy Institute of California.

Gao, Niu, Julien Lafortune, and Laura Hill. 2020. Who Is Losing Ground with Distance Learning? Public Policy Institute of California.

Gao, Niu, Laura Hill, and Julien Lafortune. 2021. Distance Learning Strategies in California Schools. Public Policy Institute of California.

Garet, Mike, Jordan Rickles, Jill Bowdon and Jessica Heppen. 2020. National Survey on Public Educations Coronavirus Pandemic Response. American Institutes for Research.

Haag, Susan and Colleen Megowan. 2015. Next Generation Science Standards: A National Mixed-Methods Study on Teacher Readiness. School Science and Mathematics 115(8): 416 426.

Hamilton, Laura, Julia Kaufman and Melissa Diliberti. 2020. Teaching and Leading through a Pandemic: Key Findings from the American Educator Panels Spring 2020 COVID-19 Surveys. RAND Corporation.

Kennedy, Mary. 1998. Form and Substance in In-Service Teacher Education. (NISE Research Monograph No. 13). National Center for Improving Science Education, University of Wisconsin.

Krajcik, Joseph, Susan Codere, Chanyah Dahsah, Bayer Renee and Kongju Mun.2014. Planning instruction to meet the intent of the Next Generation Science Standards.Journal of Science Teacher Education,25 (2): 157-75.

Legislative Analysts Office. 2022. The 2022-23 Budget: Overview of the Governors Budget.

Macias, Meghan, Ashley Iveland, Burr Tyler and Maya Salcido White. 2022. Teaching K8 Science Through Distance Learning : Specific Challenges and Successes During the COVID-19 Pandemic. WestEd.

National Academy of Sciences. 2021. Call to Action for Science Education: Building Opportunity for the Future. Washington, DC: The National Academies Press. https://doi.org/10.17226/26152.

National Center for Education Statistics. 2017. Teacher Professional Development.

National Research Council. 2014. Guides to Implementing the Next Generation Science Standards. National Academies Press.

National Science Teaching Association. 2018. Transitioning from Scientific Inquiry to Three-Dimensional Teaching and Learning.

National Science Teaching Association. 2021. K12 Science Standards Adoption.

NGSS Early Implementers. 2018. Next Generation Science Standards in Practice: Tools and Processes Used by the California NGSS Early Implementers. WestEd.

Penuel, William R., Christopher J. Harris, and Angela Haydel DeBarger. 2015. Implementing the Next Generation Science Standards.Phi Delta Kappan,96 (6): 4549.

Pruitt, Stephen. 2014. The Next Generation Science Standards: The Features and Challenges. Journal of Science Teacher Education 25(2) 145 156.

Reiser, Brian J. 2013. What Professional Development Strategies Are Needed for Successful Implementation of the Next Generation Science Standards? Center for K12 Assessment & Performance Management, Educational Testing Service.

Schwartz, Heather, and Melissa Diliberti. 2022. Flux in the Educator Labor Market: Acute Staff Shortages and Projected Superintendent Departures. RAND Corporation.

Stage, Elizabeth, Harold Asturias, Tina Cheuk, Philip Daro and S.B. Hampton. 2013. Opportunities and Challenges in Next Generation Science Standards. Science 340(6130): 276 277.

Supovitz, Jonathan A., and Herbert M. Turner. 2000. The Effects of Professional Development on Science Teaching Practices and Classroom Culture. Journal of Research in Science Teaching, 37 (9): 96380.

Trygstad, Peggy J., P. Sean Smith, Eric R. Banilower, and Michele M. Nelson. 2013. The Status of Elementary Science Education: Are We Ready for the Next Generation Science Standards? Horizon Research.

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The Impact of COVID-19 on Science Education - Public Policy Institute of California

How COVID-19 will pave the way for better and more accessible education in Brazil – World Bank Group

June 22, 2022

It is safe to say that the COVID-19 pandemic has left a mark in every aspect of our lives. Taking the economy for example, the destruction trail left by the virus is made clear when 38 million US citizens apply for unemployment benefits (compared to the 5.8 million that applied pre-covid), or when the stock market goes through a roller coaster motion every other hour.

While the financial turmoil is widely discussed by politicians and experts, other consequences of the pandemic receive little to no attention from the authorities. For instance, the emotional toll brought by the sudden change in educational formats. Leaving both teachers and students in an academic limbo, the transitioning to the online system was turbulent. As the COVID-19 cases rose, so did the number of dropout students due to financial complications, demotivation, or lack of future perspective.

Unfortunately, few institutions put effort into making online school an enjoyable and valid format of learning, but the ones that did paved the way for quality education solutions.

A good example is the inverted classroom method, which got popular in Brazilian High Schools and kept students from dropping out, ensuring them independence to learn on their own way. In this method, the teacher shares reliable sources and leads the class so they can study by themselves. After the students have read the material, an online meeting is held, the subject is discussed, and eventual doubts are solved.

The inverted classroom encourages healthy studying habits, stimulates the establishment of a routine, and makes learning a much more personalized and rewarding experience. The teacher assumes a tutor role, rather than an authority one, and helps each student with their own necessities.

Another solution found by Brazilian public school teachers was to designate some students as tutors to help younger students struggling with their learning process. The tutor receives a monthly stipend, in exchange of correcting other students homework, providing extra material, and giving an online review weekly.

In addition to such methods, teachers could implement new evaluation mechanisms, leaning on exercises, summaries, text productions, and experiments, rather than on tests. This trade would benefit students, as they practice on what they have learnt.

The public schools that successfully implemented online teaching methods were recognized by the Brazilian National Council of Secretaries of Education. In December 2020, 5 schools were awarded with the School Management Award, including one in a rural area. The first place was awarded with a 30 thousand Brazilian Reais prize to invest in equipment.

As a public-school student, I have seen my teachers struggle with switching from one method to another, fighting to assure proper equipment to those who did not have it. It is refreshing to know the effort will not go to waste. The newly adopted methods (and the ones that are to be) will continue to improve learning and its accessibility, by combining technology and passion for education.

Announcing winners of the fourth World Bank Group and Financial Times youth blog competition

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How COVID-19 will pave the way for better and more accessible education in Brazil - World Bank Group

COVID-19 severity and air pollution: What’s the link? – Medical News Today

June 22, 2022

Nitrogen dioxide (NO2) is a traffic-related pollutant gas released when burning fossil fuels.

Long-term exposure to NO2 causes many health problems and is linked to a higher risk of all-cause, cardiovascular and respiratory-related death.

A study conducted with healthcare data from 4,443 fatal cases of COVID-19 in 2020 found that long-term exposure to high levels of nitrogen dioxide correlates to increased mortality risk from COVID-19.

Knowing how long-term nitrogen dioxide exposure affects COVID-19 outcomes could help policymakers better allocate resources to treat the condition.

Recently, researchers investigated the effects of long-term NO2 exposure and the need for ICU and mechanical ventilation treatment for COVID-19.

They found that long-term NO2 exposure was linked to an increased need for ICU care and mechanical ventilation.

Researchers presented the findings at the Euroanaesthesia Congress in Milan, Italy.

The researchers gathered air pollution data from 2010 to 2019 for 392 of Germanys 402 counties for the study. They used this data to calculate long-term annual mean levels of NO2, ranging from 4.6 g/m to 32 g/m. The lowest levels were in Suhl and the highest in Frankfurt.

They also gathered data on the number of occupied ICU beds and the need for mechanical ventilation from the German Interdisciplinary Association for Intensive Care and Emergency Medicine registry from April 16, 2020, to May 16, 2020, when government officials lifted lockdown restrictions.

Next, they analyzed the data and adjusted their findings for demographic factors such as population density, age and sex distribution, socioeconomic factors, and health parameters such as pre-existing health conditions affecting COVID severity.

Altogether, they noted that there were 169,840 cases of COVID-19 in Germany until May 16, 2020, and 8,433 COVID-related deaths.

Their data analysis found that an increase of 1 g/m3 NO2 was linked to a 3.2% higher need for ICU care and a 3.5% higher need for mechanical ventilation.

When asked what might explain the studys findings, Dr. Tia Babu, Acting Assistant professor in the Divison of Allergy and Infectious Diseases at the University of Washington, not involved in the study, told Medical News Today:

Nitrogen dioxide exposure is associated with a myriad of effects to the lungs, including lung injury, decreased lung function, and inflammation, Dr. Babu said. Perhaps the chronic exposure to nitrogen dioxide leads to decreased pulmonary function or an abnormal local lung immune response to the SARS-CoV-2 virus.

MNT also spoke with Dr. Fady Youssef, a board certified pulmonologist, internist, and critical care specialist at MemorialCare Long Beach Medical Center in Long Beach, California. Dr. Youssef was not involved in the study.

He said pollutants can promote a proinflammatory state in the lungs that can have an additive effect on inflammation triggered by COVID-19.

Dr. Susanne Koch, a professor at the Department of Anaesthesiology & Intensive Care, Charit Universittsmedizin Berlin, Germany, lead author of the study, explained this additive effect to MNT:

[A protein called] ACE-2 helps put the brakes on inflammation, but exposure to air pollutants triggers inflammation or releases the brakes. And again, when the SARS-CoV-2 virus binds to ACE-2, these brakes are removed, which leads to an additive effect, more severe inflammation and a more severe course in COVID-19.

The researchers concluded that individual risk for COVID-19 morbidity is influenced by long-term exposure to NO2.

When asked about the studys limitations, Dr. Koch told MNT that due to the cross-sectional, epidemiological design of the study, their research does not guarantee causal relations. She also noted that as many risk factors for COVID-19 may be triggered by air pollution, their models may underestimate its impact on health.

Dr. Youssef added: There are many other variables that can be associated with environments where NO2 levels are elevated that could be responsible for the correlation, [although] the study did control for some of them.

Babu noted that examples of these other variables, including differences in medical practices in urban areas such as increased ICU care capacity, may have contributed to the studys observations.

Liuhua Shi, ScD, Assistant Professor at Gangarosa Department of Environmental Health at Emory University, further explained that NO2 might also serve as a proxy for unexamined traffic-related air pollutants such as soot, trace metals, and ultrafine particles.

Dr. Shi added that the study did not assess real-time exposures and that country-level features may not represent the features of individual COVID-19 patients, meaning that their adjustment for socioeconomic, health and demographic factors may be inadequate.

When asked about what this study means for the environment, Koch explained:

While the COVID-19 pandemic may end by reaching herd immunity through infection or vaccination, exposure to ambient air pollution will continue to affect peoples health. The only remedy is reducing emissions.

The transition to renewable energy, clean transportation, and sustainable agriculture is urgently needed to improve air quality, which will also help mitigate climate change, to improve population health and quality of life around the world, she concluded.

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COVID-19 severity and air pollution: What's the link? - Medical News Today

Chinas Covid-19 Controls Force U.N. Biodiversity Conference to Move to Canada – The Wall Street Journal

June 22, 2022

HONG KONGChinas hosting of a major United Nations conference on biodiversity has already been pushed back four times because of the countrys tight Covid-19 travel restrictions. Now, the conference will be moved outside China, making it the latest casualty of strict pandemic controls that have hampered Beijings ability to project its diplomatic and cultural clout on the world stage.

The Secretariat of the Convention on Biological Diversity, the U.N. body that stages the biodiversity conference, said Tuesday that the meeting, known as COP15 and originally slated to be hosted in the southwestern Chinese city of Kunming, would be moved to Montreal and held in December.

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Chinas Covid-19 Controls Force U.N. Biodiversity Conference to Move to Canada - The Wall Street Journal

New Novavax COVID-19 vaccine could address inequity and demand – The Well : The Well – The Well

June 22, 2022

As Novavax clears a key step on the path to FDA authorization, researchers with the UNC Institute for Global Health and Infectious Diseases hold hope for a COVID-19 vaccine that can address vaccine inequity and demand.

Dr. Cindy Gay, associate professor of infectious diseases in the infectious diseases division in the School of Medicine, led the phase 3 Novavax study at Carolina and is co-chair for the overall study. She answers questions about the vaccine in a new UNC Health video.

There are different ways to design a vaccine. The Moderna and Pfizer mRNA vaccines use a strategy whereby the vaccine delivers an instruction code that gets delivered inside our cells. Then, our own cells are instructed to make a piece of the virus to elicit an immune response which provides protection against COVID-19 illness.

Novavax is a protein-based vaccine using a much more traditional vaccine platform. Several vaccines approved for infections have been using this platform for decades. With this strategy, the vaccine itself delivers the piece of the COVID-19 virus that we want to elicit the immune response to. Its the same spike protein that is eliciting a response with the other COVID-19 vaccines, but in this case, its being delivered directly in the vaccine.

The Novavax vaccine was 90.4% effective in preventing symptomatic COVID-19 illness. The data submitted to the FDA covers an early period in the study, including when the delta variant was circulating and when the omicron variant had yet to emerge.

However, Novavax looked at immune responses to the omicron variant and, more importantly, neutralizing responses. The Novavax vaccine did elicit immune responses to the omicron variant, but it provided less protection compared to the initial Wuhan strain and the other variants, as weve seen with all of the currently available COVID-19 vaccines. Studies also looked at responses after a booster dose, provided in this phase 3 study. Results showed substantial increases in response, including to the omicron variant.

UNC was a site for the phase 3 study of the Novavax vaccine through the Institute for Global Health and Infectious Diseases. This is a two-year study, and we are continuing to follow participants for safety monitoring and additional immunological testing. In addition, UNC was a site for the enrollment of adolescents on the study, from age 12 to 17, and we continue to follow them as well.

Given where we are with vaccination rates in the U.S., its most likely that Novavax, if approved for emergency use authorization, would be used as a booster dose. However, emergency use authorization submission and approval would be for an initial or primary series. Many of us are hopeful that individuals who remain unvaccinated and concerned about newer mRNA vaccines will be willing to try this more traditional approach to a vaccine. Its already been approved in several other countries, including the European Union, and cleared by the World Health Organization. There have been no safety issues with the phase 3 study in the U.S. and Mexico, or in a large U.K. study.

One key advantage is that Novavax does not have to be frozen. In many ways, this will make it a much more accessible vaccine once it becomes widely available, as transportation and access to freezers can be an issue with other COVID-19 vaccines. The logistics and storage required to deliver the Novavax vaccine to rural settings and low resource countries would be much easier, making this is an important vaccine for getting more individuals vaccinated while addressing vaccine inequity.

Learn how the built-in infrastructure of Carolinas Clinical Trials Unit in the Institute for Global Health and Infectious Diseases brought COVID-19 vaccine trials to UNC-Chapel Hill, starting with Moderna.

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New Novavax COVID-19 vaccine could address inequity and demand - The Well : The Well - The Well

‘Stay humble at the outset’: 4 physicians on how COVID-19 shaped infectious disease work – Becker’s Hospital Review

June 22, 2022

As the monkeypox outbreak evolves, hospitals are reflecting on the early days of their COVID-19 response.

Globally, there have been more than 2,500 confirmed monkeypox cases as of June 17. In the U.S., there have been 113 cases across 20 states and Washington, D.C.

Amid the possibility that more hospitals will treat patients infected with the monkeypox virus, Becker's asked physician leaders the following question: How have lessons from the COVID-19 pandemic shaped your preparation and response to other infectious disease outbreaks?

Four responses:

Editor's note: Responses are lightly edited for brevity and clarity.

Ohm Deshpande, MD. Vice President of Population Health and Clinical Financial Services at Yale New Haven (Conn.) Health: Our coordinated systemwide COVID-19 response that began in 2020 was key to our ability to move nimbly, iterate our treatment pathways quickly in response to emerging research, and scale them across our 2,600 inpatient beds and hundreds of ambulatory sites. The effectiveness of our coordinated infrastructure was proven by the fact that COVID-19 mortality for our entire system, inclusive of our quaternary care academic center and our four smaller hospitals, was among the lowest in the nation and by far the lowest in Connecticut. Our Care Signature clinical convergence/standardization initiative was instrumental to coordinating our clinical experts and implementing their wisdom into front-line clinical workflows. For monkeypox, and future infectious disease outbreaks, we are leveraging our Care Signature approach to ensure the most up-to-date clinical management algorithms are easily accessible at the point of care. Doing so will ensure patients are appropriately navigated, our clinicians are well supported, and that we can identify and safely and effectively manage the patients and communities we serve.

Soniya Gandhi, MD. Associate Chief Medical Officer and Vice President of Medical Affairs at Cedars-Sinai (Los Angeles): The COVID-19 pandemic has created many important opportunities for growth that will improve our response to future infectious disease outbreaks. COVID-19 forced us to collaborate across disciplines that are often siloed within healthcare organizations. Clinicians and operational leaders had to nimbly meet the ever-changing needs of patients and employees while working with communications professionals to share new information with these audiences. The pandemic also made it clear that healthcare organizations must be prepared to quickly meet an increased demand for services. This ability to scale up services requires a robust supply chain, a reliable pipeline for PPE and a plan to expand capacity. Lastly, our providers have become accustomed to using enhanced PPE. This familiarity should make them feel more comfortable and capable when responding to future outbreaks.

Susan Kline, MD. Infectious Disease Expert at M Health Fairview and the University of Minnesota Medical School (Minneapolis): I will always remember that an emerging infectious disease could surprise us and carry a greater pandemic potential than might be apparent at the outset. We need to stay especially humble at the outset of an outbreak, especially if it is with a novel pathogen. That new pathogen may not follow the patterns of previous infectious disease outbreaks.

The COVID-19 pandemic and the new monkeypox outbreak have proven that we are more closely interrelated than ever before in human history. Diseases that were previously in one country or continent can now easily spread around the world. To be better prepared for the next unusual and emerging infectious diseases, we need to make it easier for primary care clinics and hospitals to detect these illnesses rather than centralizing diagnostics at a small number of specialized labs with difficult patient access.

Additionally, we must continue to invest in research of infectious diseases and expand our capability for treatment and prevention of these emerging infections with vaccines and therapeutic agents. And we must carefully consider and prepare for the unintended consequences that disease mitigation strategies may have on the economy, education, patient care and mental health.

Colleen Kraft, MD. Associate CMO at Emory University Hospital (Atlanta): At Emory Healthcare, we have been thinking about preparation and response to pandemics and healthcare employee safety since 2002. Our multidisciplinary teams within Emory's Serious Communicable Diseases Unit/Program based at Emory University Hospital can rapidly mobilize and access a multitude of resources, which can extend to the rest of our system when needed. With every surge during the pandemic thus far, having that bedrock has helped us in clinical decision-making and healthcare worker support.

There are several manuscripts published about Emory's close involvement with the National Emerging Special Pathogens Training and Education Center, which was established in 2015 to prepare and care for patients with Ebola virus disease and other special pathogens in the United States. Emory Healthcare is one of 10 Regional Emerging Special Pathogen Treatment Centers, which undertook readiness activities that enabled them to play a pivotal role in the nation's COVID-19 pandemic response. A second paper illustrates the value of biocontainment units in the current pandemic and their potential role in preparing healthcare facilities and health systems for future infectious disease threats

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'Stay humble at the outset': 4 physicians on how COVID-19 shaped infectious disease work - Becker's Hospital Review

Managing challenging behaviors in the midst of Covid-19 | PRBM – Dove Medical Press

June 22, 2022

BackgroundDefinitions and Concepts

Behavior can be described as challenging when it exhibits a recurrent pattern or interferes with or is at risk of interfering with optimal learning or engagement in prosocial interactions with peers and adults.1 Emotional dysregulation and challenging behaviors may adversely impact interpersonal competences and academic performance, leaving the child with enduring effects.2 However, cultural sensitivity led to variations in distinguishing what is deemed inappropriate behavior considering the different norms and beliefs.3,4

Behavioral problems have been grouped into two broad spectrums: internalizing and externalizing.5,6 Internalizing behaviors are expressed inward and often go undetected, such as difficulty concentrating, being anxious, persistent avoidance of activities, social withdrawal, crying or hiding.6,7 Externalizing behaviors are expressed toward the outer environment such as hitting, spitting, property destruction, fleeing and yelling.6,7

However, it is not uncommon for children and adolescents to exhibit co-occurring disorders of both types.8 For instance, food insecurity, homelessness, exposure to violence, abuse or neglect may lead to both internalizing (eg, being secretive, self-conscious, experiencing aches and pain, anxious, fearful) and externalizing challenging behaviors (eg, exaggerated startle responses, aggression, bullying or fighting).69

COVID-19 and the imposed restrictive measures have affected to a large-scale the psychological wellbeing of children and adolescents.10 Disruption of daily routines and shifting into remote learning have resulted in an increased frequency or severity of challenging behaviors, representing a particular source of stress to parents/families.11 A study conducted during the early stages of the pandemic in the Philippines indicated that having a higher number of children in the family was positively associated with a higher level of psychological distress.12 Furthermore, Ren et al13 in their study evaluated the psychological impact of COVID-19 following school reopening and found that 32.4% of students showed symptoms of depression, while 15.5% exhibited anxiety symptoms. The study also revealed that those at higher grades and fears of being infected were at greater risk of adverse psychological outcomes.13

Comparative results were obtained even at later stages of the pandemic. Among 1771 adolescents in China, depression and anxiety were estimated to be 30.8% and 28.3%, respectively. Sleep quality, resilience, social/school status, perceived social support, and adaptive coping strategies were amongst the protective factors, while maladaptive coping strategies were a risk factor.14

Challenging behaviors are relatively prevalent, even prior to the emergence of COVID-19. A study in Boulder County, USA, indicated that yells and screams (73%), hurting oneself/others (69.5%), and getting irritable/frustrated easily (66.1%) were amongst the most common challenging behaviors reported by parents.15 In New Zealand, a parental survey of 10,457 children aged 3 to 14 years revealed that 8% of children had substantial social, emotional, or behavioral issues, while 7% had a borderline score.16

Several interrelated factors have been shown to influence childrens behavior, including developmental, environmental, and socio-cultural aspects.17 The prevalence of challenging behaviors in young children was estimated to be about 10% and may reach as high as 25% for those coming from low-income families.17,18

Preschoolers are three times more likely to be expelled from a childcare program due to active behavioral problems, as compared to grades K12.19 Aggressive and antisocial behaviors may persist beyond the age of three in about 3 to 15% of preschool-age children.20 Approximately, half of these children are embarking on a path that will inevitably lead to delinquency and criminal acts in adolescence and adulthood.21

While some children may outgrow this kind of behavior by the time of school entry, others demonstrate persistent and even intensifying patterns, leading to academic failure and social maladjustment.22 Fifty percent or more of toddlers and preschoolers with disruptive disorders were found to exhibit challenging behaviors at least up to four years later.16

In a qualitative study conducted by Fox et al17 families reported that behavioral problems invariably impacted the family structure, routines, and activities. The conclusion of the study has given support to the system perspective, which considers children and family struggles to be the product of interconnected family situations rather than a single environmental element.23

Disruption of daily routines, home confinement, lack of coping strategies, and changes in sleeping and eating patterns over the period of the COVID-19 pandemic are likely associated with rising rates of mental health challenges, most markedly among children, adolescents, and their families.24 Evidence from several studies2530 indicated the importance of early management of behavioral problems in prevention of future risks and adverse outcomes. For example, mental health difficulties, physical health burden, relationship and parenting problems, substance abuse and sexual risk taking.2530 Hence, structured regulation strategies tackling emotional, behavioral, and psychological perspectives are pivotal to mitigate the adverse effects of the pandemic. Understanding the factors that influence behavior is useful for successfully implementing effective interventions.

Thus, the present review aims to synthesize the available literature on (i) the impact of COVID-19 on children and adolescents behaviors (ii) determinants of challenging behaviors in relation to environment and social-emotional development; and (iii) a family-centered strategic interventional framework for the management of such behaviors.

We reviewed the literature pertaining to determinants and intervention strategies aimed at managing challenging behaviors among children and adolescents. We conducted an electronic search for studies from July 2021 through September 2021, using the following electronic databases: PubMed, ScienceDirect, Medline, and Scopus. A combination of the following keywords was used to search for titles and abstracts: challenging behavior OR maladaptive behavior OR social-emotional OR internalizing OR externalizing OR children OR adolescents OR Pyramid Model OR COVID-19 OR Behavioral intervention OR positive behavioral support OR family-centered OR school. We then conducted hand searches using reference sections from retrieved articles. To maximize the potential of studies included no restriction to publication date or language was applied.

The inclusion criteria established for the selection of the articles were: (1) focusing on children and adolescents behavior up to 18 years old; (2) addressing developmental and socio-emotional determinants of challenging behavior; (3) discussing the impact of COVID-19 on children/adolescents behavior; (4) Provide assessment of challenging behavior using Positive Behavioral Support, and (5) manage in the context of families and/or schools. Articles were excluded from the review if they examined children with developmental or mental disabilities due to the likelihood of interference with the prevalence, severity, assessment, or management of challenging behaviors.

Two independent reviewers were involved in the database search, and any disagreement was resolved by discussion or by a third reviewer. Articles that met the selection criteria were retrieved for this review and the relevant contents of the articles were divided into five theoretical categories, including: (i) developmental milestones; (ii) the Pyramid Model; (iii) Positive Behavioral Support; (iv) management strategies for challenging behavior in the context of families and schools; and (v) the impact of COVID-19 on childrens or adolescents behavior.

It is critical to recognize the age-appropriate childhood developmental milestones (ie, motor, verbal, social, emotional, and cognitive skills) as markers for behavioral acts, particularly throughout the transition into more advanced milestones.31 Some challenging behaviors are developmentally appropriate for youngsters as they gain new abilities and progress through life stages.32 For example, the peak of physical aggression between the ages of 17 and 42 months is considered typical in this developmental period.33

Transitions such as separation from parents, attempting to be more independent, or frustration due to a lack of abilities may stimulate emotional distress.34 Nevertheless, it is important to acknowledge that every behavior serves a function or purpose. For example, communication difficulties such as delayed language or speech or poor social competence may trigger challenging behavior as a way of communicating with their environment, especially during anxious or stressful situations.35

The Pyramid Model is an evidence-based, multi-tiered framework that supports young childrens social, emotional, and behavioral development in early years settings.36 It is conceptualized to provide three levels of intervention practice: universal promotion for all children, secondary preventions for those at risk of social emotional delays, and tertiary interventions for those with persisting behavioral problems37 (Figure 1).

Figure 1 The Pyramid Model.

Targeted social-emotional support: the focus of this level is to support social skills and emotional regulation, especially for at risk children who need more systematic and focused instructions.41 Children are assisted in expressing their emotions, improving problem solving skills, cooperative responding, peer interaction, and dealing with negative emotions such as anger.4143 For example, parents and teachers can lead activities through behavioral modeling and role-play with positive reinforcement strategies when a desired behavior is demonstrated.41

Individualized intensive intervention: children with persistent behavioral problems not responding to previous tiers are offered a rigorous, tailored intervention using PBS. Progress is continuously monitored in relation to specific pre-determined goals.44,45

PBS is a person-centered, evidence-based strategy to assist children with behavioral problems in a variety of settings.46 It deems challenging behavior as a product of multiple interactive variables of interpersonal relationships, physical environment, reactions of others and the way support is provided.47 Individual factors such as trauma, intellectual disability, general health, and mental health should all be considered.48,49

PBS is most effective when planned strategies are implemented in a consistent manner.50 Families and teachers are encouraged to work together to achieve the level of fidelity required to produce desirable outcomes.50,51 PBS consists of four main steps: FBA; developing a hypothesis about why the behavior is happening; undertaking a functional behavior analysis to test the hypothesis; and developing a BIP.51,52

FBA is a method used to identify the associations between physiological or environmental factors and behavioral problems.53 The goal is to detect variables related to the occurrence of a specific behavior and to determine the function or purpose of that behavior in relation to one of four categories:53 social attention, escape, tangible, ie, the desire for certain things, or sensory, ie, internally rewarding or assisting in coping with negative emotions such as boredom or anxiety.

Topography, incidence, and duration of behavioral problems are identified through interviews, observations, and analysis.54 Precedent events that occur prior to the problematic behaviors are outlined, as are the consequences that maintain the behavior.54 Successful implementation of PBS was shown to be effective in minimizing challenging behavior through enhancement of new target skills.5559

Behavior is assessed broadly in three stages: indirect, direct, and hypothesis testing.60 Indirect evaluation includes gathering information from existing databases through interviews with parents, teachers, or peers.60 The key is to establish a valid definition of the target behavior. For example, a defiant tantrum can be expressed by throwing materials off the desk, folding the arm and/or using inappropriate language. In the direct stage, extended analysis is carried out to identify frequency, duration, topography, and the environment in which the behavior occurs. In the final stage, hypothesis testing aims to translate the findings of previous steps into an A-B-C statement that addresses the causes of the problematic behavior, the consequences that reinforce a behavior, and the provision of replacement behaviors. Examples of ABC observation for challenging behavior are illustrated in (Table 1) and real-world scenario examples of ABC behavior are shown in (Table 2).

Table 1 Examples of ABC Observation for Challenging Behavior

Table 2 Real Scenario Examples of ABC Observation

BIP consists of multicomponent interventions that are aligned with patterns observed throughout the assessment.61 Given that behaviors can be context-dependent (eg, a child only hits when sibling takes away his toys) and multi-functional (eg, screaming occurs both to obtain parental attention and delay certain tasks), combined interventions are usually recommended.61

BIP include a clear explanation of the behavior, the relationship between cause and effect, interventions used and their outcomes, behavioral goals, a plan for supporting new behavior, a description of success, evaluation, and monitoring process.62,63

When an intervention strategy is selected, guidance might aim for either changing the antecedents and/or the consequences related to a behavior (ie, using antecedent and consequence strategies) or developing more socially appropriate and adaptive replacement skills.63 Focusing on behavioral triggers, antecedent interventions promote behavioral change through either eliminating or adding antecedents that ultimately reduce the likelihood of challenging behavior.64 Examples of ABC strategies by behavioral function are presented in (Table 3).

Table 3 Examples of ABC Strategies by Behavioral Function

In school settings, interventions may include environmental modifications such as allowing students to sit in a specific location in the class or providing a quiet, distraction-free environment. Working in small groups, changing tasks, oral tests, curriculum material adaptations and group/individual counselling, are further examples.59,65 Flowchart of FBA and BIP is illustrated in (Figure 2).

Figure 2 Flowchart of Functional Behavioral Assessment (FBA) and Behavioral Intervention Plan (BIP).

Aside from educating a child on the appropriate methods of communication, the way parents/teachers react to a particular behavior remarkably contributes to the duration, frequency, or intensity of such behavior.58 A message should be conveyed to the child that challenging behavior will not be successful.

The verbal or physical redirection method is a simple but highly effective strategy for shifting a childs behavior into a more desirable one.66 For example, once Sarah appears ready to toss a toy when she is not getting attention, her mom can redirect her by saying, As soon as you put away the toys, we can read your favorite bedtime story.

Being primary caregivers, parents are considered the most valuable resources for the management of challenging behaviors.67 Interventions are more likely to have an impact when parental focus is shifted from consequences to reasons of misbehavior.33 Parental coaching aims to support parents in employing new skills when challenging behaviors occur. It is based on problem-solving skills gained through scaffolding, with an emphasis on three areas of support: cognitive, emotional, and autonomy.57

Family-centered methodology works on improving parents capacity to principally understand their childs social and emotional cues and consequently, promote self-regulatory behavior and emotional intelligence.68 Natural environments such as home and school are considered the ideal settings for interventions, allowing observation of multiple interrelated factors that can affect childrens behavior.69,70 Lucyshyn et al71 demonstrated the significance of interventional modeling and parental coaching through problem-solving discussions, behavioral rehearsal, self-monitoring, and evaluation.

The aim of the model is to foster family involvement in supporting their childs early development. Instead of addressing behavioral problems with either parents or children independently, strategies are viewed in terms of parent-child interactions.72 Roggman et al73 proposed that parents need to be actively supported in recognizing their own resources, strengths, and needs, focusing on their own children rather than a standardized curriculum. Helping parents discuss their ideas, actions in place, and feedback with the provision of problem-solving scenarios are crucial for successful outcomes.74

The way in which adults provide children assistance to obtain new skills as they grow through the stages of development is described as scaffolding.75 For instance, caregivers may breakdown a certain task into smaller, simple steps and provide elements of basic understanding that will help in the solution and actual demonstration of the task. To enhance the effectiveness of scaffolding and reduce the level of frustration caused by lack of skill, modelling, provision of hints or cues, and adapting materials may be used.75

Scaffolding has been identified as a high-quality parenting approach leading to favorable behavioral tendencies and self-regulation using childrens own abilities.76 Prior to the occurring of a challenging behavior, it is important for parents to teach their children problem solving skills instead of long speeches that the child may or may not comprehend.77 Three types of scaffolding have been identified, including cognitive, emotional, and autonomous.33

This type of support aims to empower children to understand and apply new strategies, review problem solving steps, and realize rational underlying decisions in the direction of self-guided learning.26 Through effective feedback, cognitive support helps children accept different viewpoints and create a balance between pride in their abilities and recognizing the importance of reliable guidance that promotes self-confidence.78

Scaffolding with emotional support implies the use of positive reinforcement, verbal, and nonverbal communication to enhance emotional regulation.33 Mothers who help their children develop emotional literacy and teach coping strategies through play, storytelling, role modelling, taking turn, and sharing, tend to have children who are engaged in more prosocial behavior, while aggressive behaviors are associated with those who are inattentive of their childs emotional triggers.79

Refers as the ability of parents to provide support for their children, while preserving their independency and decision-making skills.33 Autonomy-promoting questions give opportunities for children to reflect on their own mental processes.78 For example, asking the child How do you think we should handle this? or How do you feel? enables self-expression and improve ones sense of control. Therefore, instead of asking the child to say sorry, he/she can describe their feelings and how they believe it can be-improved. Autonomy support via stimulating parent-child interaction and minimizing judgment/control will improve problem-solving abilities, empathy, compassion, and prosocial behaviors.33

The unexpected disruption of the social fabric and norms has affected the behavioral and mental health of the public, including children.8090 The psychosocial wellbeing of children has been affected in several ways, as this unprecedented situation changed the way they typically grow, learn, play, behave, interact, and regulate emotions.

Schools closures, transition into remote learning, and the absence of face-to-face peer interactions have impacted important perspectives in childrens lives. Children, especially younger ones, were deprived of opportunities such as physical activity, playing and group activities, resulting in substantial disruption to critical developmental milestones.91

In China, Wang et al92 explored the psychosocial and behavioral problems of 11,072 children and adolescents in the early stages of reopening schools. Among psychosocial behaviors, parent-offspring conflict, prolonged homework time, increased sedentary behavior and screen time, sleep problems, and physical inactivity were most frequently identified. Higher internalizing and externalizing behaviors were noted, specifically, children aged 611 who returned to school showed more depression, compulsive behavior, and hyperactivity, while adolescents of age 1216 showed more aggressive behavior, compared to those who were home schooled.92,93

Previous studies have demonstrated that in addition to the increase in clinging, inattentive and irritability documented at the beginning of the epidemic, with its link to disrupted school and daily routine, poor dietary habits leading to obesity, and increased use of electronic devices, can further aggravate adverse effects on children and adolescents.9496

School reopening has brought a ray of hope around the world in terms of restoring the sense of structure and stimulation necessary for childrens psychosocial wellbeing.97,98 However, the readjustment period is expected to deal with several negative sequelae emerging from academic pressure, students relationships with teachers and peers, and difficulty adjusting to school routine.

Previous studies indicated that academic pressure driven by parents or teachers expectations, irrespective of age and sex, was amongst the most identified stressors in students.99,100

Children who were disproportionally affected including those with preexisting mental health concerns, developmental disorders, learning disabilities or any other challenges may experience greater adjustment issues and require individualized learning plan with additional support.101

This review had certain limitations, mainly attributed to the subjective nature of the narrative style literature. First, there is the possibility of misinterpretation of results and drawing conclusions (which is usually due to selection bias, subjective weighing of included studies, and unspecified data synthesis). To mitigate this limitation, we adopted several methods (ie, forming a search strategy, the process of selection and data synthesis) more characteristic of systematic reviews. Use of these methods helped to reduce selection bias by ensuring our source selection decisions were procedurally structured and precise.

The second limitation is the inclusion of a small number of studies that were conducted during the COVID-19 pandemic, creating a perception of theoretical rather than practical relevance. To overcome this limitation, we have enriched the introduction with additional post-pandemic (at early and later stage) study results to show the significance of the increasing trends and potential related mental health illness.

The results of the present review highlighted the considerable impact of the COVID-19 pandemic on children/adolescents behaviors and their mental wellbeing. Identifying behaviors determinants in the context of developmental, environmental, and sociocultural remains the key step to mitigating the adverse effects such as social maladjustment, academic failure, and future risky acts. Scalable and family-based mental health interventions built on the Pyramid Model, FBA, and BIP will promote effective and sustainable outcomes.

The present review supports that enhancing parental capacity through training, coaching, and empowering them to identify their own resources and strengths will help construct positive parent-child interactions. Additional attention should be given to the children/adolescents who are more susceptible to mental health challenges through a collaborative approach involving parents, schools, healthcare providers, and mental health services.

Owing to the COVID-19 containment measures and the impediment to traditional face-to-face services, other innovative psychological supports, such as Internet Cognitive Behavioral Therapy, may be an effective alternative to reduce barriers to access mental health resources.

The empirical literature synthesis focuses on several key stakeholders (parents, schools, practitioners, community, policymakers, and researchers) who work with children or adolescents. The framework of Functional Behavioral Assessment and Behavioral Intervention Plan offers a strategic template that facilitates and supports a comprehensive array of evidence-based services components, from developmental surveillance, promotion, and prevention to intensive intervention, through an individualized plan tailored to the child and familys needs.

Professional development for practitioners, schools, and parents is important to ensure they have the adequate skills and knowledge to conduct behavioral assessments, identify determinants, socio-emotional competences, and implement effective interventions within natural environments accordingly. The current review provides an expanded understanding of the role of mental health support within the school environment, allowing for continuous monitoring and evaluation.

The results from this review have provided sufficient grounds for further longitudinal research to examine the impact of supportive environments, parental coaching, and interventions on childrens behaviors as well as the consequences of persistent challenging behavior in developing future mental health illnesses or risky acts. Another avenue for research would be to examine the adverse effects related to COVID-19 restrictive measures on the mental health of children, adolescents, and families.

Not applicable because of review type of the article. All data and material are available under references.

All authors approved the final version to be published and agree to be accountable for any part of the work.

Open Access funding provided by the Qatar National Library.

The authors declare that the manuscript was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Managing challenging behaviors in the midst of Covid-19 | PRBM - Dove Medical Press

What Happens to Community Care When the Government Decides Its Every Person for Themselves in the Face of COVID-19? – Well+Good

June 22, 2022

Back in February of 2021, mental-health educator and wellness coach Minaa B. wrote about the concept and importance of community care in an op-ed for Well+Good: "The idea of community care, essentially, is to use our power, privilege, and resources to better the people who are both in and out of our scope of reach."

There's no denying that the world looks a bit different a year and a half after she penned the piece: Airlines have lifted mask mandates and COVID-19 testing requirements for international and domestic flights, and almost every state in the country has relaxed its pandemic restrictions. But as the United States continues racing to conditions of pre-pandemic lifeeven as the number of infections continues to growthe definition of community care remains the same, and the way in which folks practice it is perhaps more important than ever. In a time when it feels that the government has more or less wiped its hands of COVID-19 as a public health issue, the honor and burden of community care falls back on individualsmeaning, you, me, each one of us. But, how?

Community-oriented care comes in many forms. While the idea and practice is prevalent across the world, the concept of public healththe American government's answer to community carestarted in the early 1900s. Since the idea found its way to American soil, the average American lifespan has increased 30 years25 of which are attributed to public-health advancements including vaccinations, safer workplaces, family planning, and cleaner drinking water.

Of course, community care has also stemmed from local, grassroots movements: The Hispanic Federation assembled after Hurricane Maria devastated Puerto Rico. Food banks have played a crucial role in feeding millions in the last few years. And, more recently, Well+Good Changemaker and Liberate Abortion leader Sharmin Hossain is leading an abortion caravan through Jackson, Mississippi, to teach people how to self-manage abortions in a time whenRoe v. Wadeis likely to be overturned. Such efforts are less quantifiable than those enacted by the government; nevertheless, they are and will continue to be vitalespecially as we navigate what community care looks like as it pertains to COVID-19.

That is, how do we practice community care in a time when public health is politically divisive; when only 67 percent of the population has been fully vaccinated against COVID-19 (and vaccination acceptance overall is on the decline)? And whendespite the fact that one million Americans have now died of COVID-19 and others live with long COVIDgetting folks to take the virus seriously remains a challenge?

I asked Isaac P. Dapkins, MD, chief medical officer at the Family Health Centers at NYU Langone, who has worked at the intersection of medicine and community care for about six years, for his thoughts. Since the start of the pandemic, he says that he and his team have spoken a lot about how doctors can orient their work toward community careand one strategy in particular has stood out to him.

When New York City became the epicenter of the pandemic in March of 2020, Dr. Dapkins saw the impact COVID-19 had on the community where he practices: Sunset Park, Brooklyn. "When we had the highest rate of infection, I think the worst part was that, if you got COVID, it really meant that you were putting your family at risk. Whether it was your older parents or your children," he says.

Folks who lived in multi-generational householdsspecifically Black people, Hispanic people, and people of Asian descentstood the greatest chance of passing a COVID-19 infection onto one or several loved ones. This risk came to define how Dr. Dapkins spoke to people about community care.

"For example, I had a woman who was in her early fifties, who was adamantly against vaccination, and she had issues that would make her at risk. I was able to connect with her about getting a vaccine by talking to her about how she would protect her motherwhom she was really worried would get sick," says Dr. Dapkins. Ultimately, he was able to convince the woman to get the vaccine for the health and safety of her family.

"The way to communicate with people is to find common ground, things that people share value-wise." Isaac P. Dapkins, MD, chief medical officer at the Family Health Centers, NYU Langone

Although not all of us are doctors, Dr. Dapkins believes that the future of community care will hinge on getting really good at talking to those we love about how their actions inform the health of their closest communities. "Doctors are really focused on communicating with individual people about their risk [for COVID-19], and I don't believe that's a very effective way to change people's minds. The way to communicate with people is to find common ground, things that people share value-wise," he says.

I know what you're thinking: Finding common ground is a difficult ask. Try as we might to use our power, privilege, and resources to connect with those who have decided the pandemic is over, and these conversations can feel like banging your hands against a brick wall. But if we stop trying, what then?

"If you're out on the street, and there's a little kid who looks like they're going to run out into the road, most people are going to stop the kid. I think there's some nugget of opportunity in that community-care conversation," says Dr. Dapkins. "Would you let a little kid run out into the street and get hit by a car? When you start to frame it in an emotional way for people that's real and doesn't have to do with sort of dry numbers and risk, it at least facilitates the conversation."

Besides having these difficult conversations, another way to practice community care right now is leading by example. If you're someone who, for instance, is fully vaccinated but still prefers to wear a mask in public spaces, wear your mask on the plane. Make it clear that you want to social distance at the supermarket. Require people to show proof of vaccination at your wedding.

The reverse is also true: Your respect and adherence to your family and friends' preferred COVID-19 safety measures is a form of community care. "Again, it's really about trying to encourage people to accept what others want to do about reducing their risk rather than focusing on what your perceived risk is," says Dr. Dapkins.

Infection rates and COVID-19-related deaths stats are importantthere's no arguing that. But when it comes to community care, human empathy may be the key to showing up for your peopleespecially when the government has decided to move on.

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What Happens to Community Care When the Government Decides Its Every Person for Themselves in the Face of COVID-19? - Well+Good

Ferry closed by COVID-19 to reopen Aug. 1, with discount only for Port Liberte residents – NJ.com

June 22, 2022

Port Liberte commuters will get a $1.30 discount per trip when the NY Waterway resumes ferry service at the development Aug. 1, company officials announced Tuesday.

The per-trip price, $11.70 for Port Liberte residents and $13 for everyone else, is the reason Jersey City has proposed purchasing the ferry terminal building there, councilwomen Mira Prinz-Arey and Denise Ridley said.

I think the press release by NY Waterway speaks to exactly the reason we are looking to acquire the ferry terminal, it puts the city and its residents at the head of these transportation discussions, said Ridley, who represents the Greenville neighborhood.

It is the citys intention for this ferry terminal to serve all Jersey City residents. I believe NY Waterway would attract more riders by evening the scale.

NY Waterway announced the reopening less than a week after the Jersey City City Council introduced an ordinance to take over the ferry terminal from the developer Ironstate for $1. The ferry service at Port Liberte, which runs to Wall Street and the Manhattan financial district, has been suspended since the start of the coronavirus pandemic in March 2020.

The NY Waterway announcement is a total slap in the face, Prinz-Arey said, since the city council ordinance calls for the city take an active role in subsidizing rates, increasing ridership, and significantly expanding access to the terminal for residents in the Greenville and West Side neighborhoods by leveraging the highly successful Via Jersey City.

The ordinance was introduced at the June 15 meeting and is expected to be approved at next weeks meeting.

NY Waterway spokesman Wiley Norvell confirmed the pricing schedule is not related to the Jersey City ordinance. The $13 charge is the highest among the companys Hudson County routes, matching Port Imperial in Weehawken.

Were excited to be back at Port Liberte, Norvell said. The prices reflect the costs of operating the ferry route, which is one of the longest in the NY Waterway system. We continue to work with the mayor and local council members on ways to lower commuting costs and increase options across the city.

The cost of the ferry out of Paulus Hook runs between $7 and $9, depending on the destination.

Mira Prinz-Arey, who represents the West Side, distanced the city from the NY Waterway announcement.

This is why we as a city are starting to walk down this path, she said. ... This is a multi-phase project. The first project is going into the lease agreement. and the next phase is looking at other possible service providers. What (NY Waterway) is doing now is fine, its a nice gesture, but it has nothing to do with the citys larger plan.

The ferries will offer direct service from the Port Liberte development to Paulus Hook and Wall Street, with connecting service to World Financial Center and Midtown.

Norvell said the service will be provided on a trial basis between August and October, and will assess future service based on ridership.

Wiley said the Port Liberte residents are being offered the 10% discount because it funded much of the construction of the facility, through the homeowners association. A 10-trip pass is $108 for Port Liberte commuters and $120 for non-Port Liberte residents.

Ferries will depart from Port Liberte between 6:05am and 9:05am, making stops at Paulus Hook and Pier 11. Returning ferries in the afternoon will depart Pier 11 between 4:15pm and 7:15pm, bound for Port Liberte.

For full Port Liberte ferry schedules and fares, nywaterway.com/PortLiberte

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Ferry closed by COVID-19 to reopen Aug. 1, with discount only for Port Liberte residents - NJ.com

Sotrovimab reduces the severity of COVID-19 progression – 2 Minute Medicine

June 20, 2022

1. In patients with mild-to-moderate coronavirus disease 2019 (COVID-19), sotrovimab reduced the risk of disease progression.

2. Sotrovimab was associated with no significant adverse events in high-risk patients with mild-to-moderate COVID-19.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Several vaccines have been approved for the prevention of COVID-19. Although, many individuals are still infected on a daily basis globally and require intervention to reduce associated morbidity and mortality. Sotrovimab is an engineered human monoclonal antibody that neutralizes SARS-CoV-2 and multiple other sarbecoviruses. It has been proposed that sotrovimab can be used in high-risk patients infected with COVID-19 to neutralize the virus and prevent disease progression early in the course of infection. However, there is a paucity of data on the efficacy and safety of sotrovimab use in high-risk ambulatory patients with mild-to-moderate COVID-19. The present study found that sotrovimab was an effective therapeutic agent for outpatients with COVID-19, resulting in a reduced risk of disease progression. This study was limited by a low number of hospitalizations in the sotrovimab group. Accordingly, it is unclear which patient or disease characteristics might be associated with sotrovimab treatment failure. Additionally, there was no analysis of baseline autologous antibody response to SARS-CoV-2 to measure immune response and status. Nevertheless, the findings are significant as they demonstrate that sotrovimab can potentially serve as a new therapeutic drug for high-risk patients with mild to moderate COVID-19 to slow disease progression.

Click to read the study in NEJM.

Relevant Reading: Early Treatment with Sotrovimab for COVID-19

In-Depth [randomized control trial]: This randomized, double-blind, placebo-controlled trial was conducted at 37 trial sites in the United States, Canada, Brazil, and Spain. Patients who were 18 years of age or older with a positive result on PCR or antigen SARS-CoV-2 testing and COVID-19 symptoms within the previous five days were eligible for the study. Patients who already had severe COVID-19, defined as shortness of breath at rest or use of supplemental oxygen, were excluded from the study. Study participants were then randomly assigned to receive either a single 500mg infusion of sotrovimab or an equal volume of saline placebo. The primary outcome was measured as the percentage of patients who were hospitalized for more than 24 hours or who died from any cause up to day 29 after randomization. Outcomes in the primary analysis were assessed via group-sequential design with two interim analyses to assess both futility due to lack of efficacy and efficacy. Based on the analysis, 1% of patients in the sotrovimab group and 7% of patients in the placebo group had disease progression leading to hospitalization or death (relative risk reduction, 85%; 97.24% Confidence Interval, 44 to 96). Within the placebo group, five of these patients were admitted to the ICU, including one who died by day 29. Regarding the safety profile of sotrovimab, 17% of patients reported adverse events in the sotrovimab group while 19% of patients in the placebo reported adverse events. Serious adverse events were also less common with sotrovimab than with placebo, occurring in 2% of patients in the sotrovimab group and in 6% of patients in the placebo group. Overall, this study demonstrates that sotrovimab reduced the risk of disease progression among high-risk patients with mild-to-moderate COVID-19 and offers a new therapeutic agent to potentially reduce the progression of COVID-19.

Image: PD

2022 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

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