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The desperate need for new vaccines and therapies to tame the deadly COVID-19 virus required new policies and procedures for how biopharma companies select, test, and manufacture medical products-and revised regulatory practices for evaluating clinical data, manufacturing operations, and procedures for submitting and analyzing information. Vaccine experts at the Center for Biologics Evaluation and Research (CBER) worked overtime to clarify the size and diversity of efficacy trials and key analytical assessments needed to gain EUA status and later full approval, establishing standards and procedures that will shape research for health emergencies to come. Officials at FDA's Office of Regulatory Affairs (ORA) indicate that the agency will continue to utilize many of these strategies for streamlining oversight of manufacturing operations, even as on-site visits increase overseas and at home, leading to a more "hybrid" inspection process going forward.
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Patients should be admitted to hospital for planned or elective care only if they have self-isolated for 14 days beforehand and tested negative for covid-19, says new guidance for trusts in England designed to increase the number of routine operations and treatments.1 People who require urgent and emergency care should be tested on arrival and streamed accordingly, with services split to make the risk of picking up the virus in hospital as low as possible, said NHS England. Patients who stay in hospital should be monitored for symptoms and retested for infection every five and seven days after admission, and those who are being discharged to a care home should be tested up to 48 hours before they are due to leave. On 15 May the government announced that more than 70 million face masks would be manufactured by a private company, Honeywell, in Scotland from July, with 4.5 million FFP2 and FFP3 masks being made each month for the next 18 months.
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The hospital's emergency coordination and response efforts emphasized addressing patients' difficulties in obtaining medical care and hospitalization in the region and keeping the mortality rate of patients with pneumonia to a minimal level. The hospital made the following significant alterations and modifications to this emergency medical care: (1) immediate establishment of the General ICU (GICU), a temporary unit set up in emergency situations that had most of the functions of but was not as complete as the ICU and had a lower ratio of doctors to nurses;(2) dynamic adjustment of anesthesiologists and respiratory physicians jointly stationed in the GICU;(3) choice of nurses with extensive experience in internal medicine and allocation to the GICU according to a 2:3 ICU bed to nurse ratio;(4) emergency purchase or deployment of pneumonia-related treatment equipment;(5) implementation of the GICU resident rotation system;(6) "twinning" of internal medicine and other departments to add beds;and (7) implementation of uniform hospital bed allocation for inpatients. The GICU resident rotation system should be implemented. * Pneumonia-related treatment equipment should be urgently purchased or deployed. * To improve the quality of care, we suggest implementing a "twinning" system between an internal medicine department and another department. * We suggest the implementation of uniform hospital bed allocation for inpatients. _____ The COVID-19 pandemic spread quickly across the world and has been deemed a worldwide public health event by the World Health Organization since its outbreak in early 2020. Through the hospital's emergency coordination and response efforts, the hospital quickly opened up 800 inpatient beds in total within a week without increasing the number of medical or nursing staff;more than 80% of the beds were for patients with COVID-19, greatly easing patients' difficulties in obtaining medical care and hospitalization in the region and keeping the mortality rate of patients with pneumonia at a minimal level.
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COVID-19 COVID-19 has undoubtedly had an impact on health care over recent years and continues to do so. [...]it is no surprise that papers on COVID-19 feature in this month's journal. Out of hospital cardiac arrest (OHCA) There are a couple of papers in this month's journal focussing on OHCA. Patient involvement in research As healthcare professionals we are ultimately there to look after and treat our patients. [...]understanding their perspective on how we do what we do is crucially important.
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Am J Manag Care. 2023;29(6):In Press _____ Takeaway Points The value of direct-to-consumer (DTC) telemedicine services offered by academic health systems is understudied. * DTC telemedicine services for low-acuity or minor illnesses are increasingly offered as an employee benefit, but any per-episode unit cost advantage may be offset by overuse of care. * DTC telemedicine staffed by an academic health system and offered to its employees resulted in lower per-episode unit costs for care within 7 days and only marginally increased the use of services. * DTC telemedicine staffed by an academic health system and offered directly to employees was cost-saving. _____ Employers in the United States have increasingly been offering a direct-to-consumer (DTC) telemedicine benefit for low-acuity or minor illnesses to their employees.1-3 By 2021, more than 95% of employers with 50 or more employees provided some coverage for DTC telemedicine in their largest health plan;more than 75% felt that offering telemedicine was important and nearly 20% either limited or eliminated cost sharing for telemedicine.4 Despite these trends among general employers, few health systems have directly provided DTC telemedicine to their own employees. [...]because these services are easy to access (often available immediately, around the clock, and without travel), they may induce overuse of care, especially for self-limited conditions such as viral upper respiratory infections for which the alternative to in-person care is no care at all, thus increasing the overall cost of care.5-11 Telemedicine will save money relative to in-person care if any unit price advantages are not overwhelmed by the increased use of care overall, induced by its convenience. Employers provide health insurance coverage for 158 million Americans or nearly 50% of the population. Since the COVID-19 pandemic began, telemedicine has represented a significantly larger portion of all medical claims—consistently more than 5% of all medical claims by mid-202112-15—and the estimated value of the global telemedicine industry is projected to reach a quarter of a trillion dollars by 2024.13 Yet, the future of telemedicine remains undetermined with reimbursement rates in debate,16-18 driven in large part because its economic value is understudied and uncertain. Penn Medicine is self-insured and more than 95% of employees use its only employer-sponsored plan—a preferred provider organization (PPO) plan—rather than insurance obtained individually or through a family member. Since 2017, these PPO-insured employees have been offered Penn Medicine OnDemand,19 a 24/7 DTC telemedicine benefit to employees and their adult (≥ 18 years) dependents.
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BackgroundThe World Health Organization defined long-COVID or post-COVID-19 condition as "the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation” [1]. Data on long-COVID in patients with inflammatory arthritis are very limited. The prevalence of this condition is 45% in the general population affected by COVID-19 who still experience symptoms after 4 months from the infection [2].ObjectivesTo investigate the persistence of symptoms after SARS-CoV-2 infection in a cohort of patients with inflammatory arthritis and the most common clinical manifestations.MethodsWe enrolled adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) classified according to standard criteria that received a diagnosis of COVID-19 through molecular, rapid or quantitative antigen swab tests between September 2020 and September 2022. Demographic and clinical data including age, body mass index (BMI), smoking habit, comorbidities, rheumatic treatment at diagnosis of COVID-19, date of COVID-19 diagnosis and clinical manifestations were collected through a questionnaire and recorded in a database.ResultsThirty-eight (40%) patients with RA, 49 (51.6%) with PsA, and 8 (8.4%) with AS [total: 95 patients;F:M=65:30, median age 56 years (IQR 15), median BMI 25.54 kg/m2 (IQR 5.58), active smokers 21 (22.1%), median rheumatic disease duration 96 months (IQR 120), median COVID-19 duration 13 days (IQR 7)] were recruited. Eighteen (19%) were only treated with csDMARDs, 38 (40%) only with bDMARDs, 29 (30.5%) with csDMARDs and bDMARDs, 8 (8.4%) were not taking any treatment and 2 (1%) were only taking glucocorticoids.Six (6.3%) patients were hospitalized (either in Day Hospital facilities for monoclonal antibodies infusion or in the emergency room). Twenty-six (27.3%) and 7 (7.3%) patients reported pre-existing cardiovascular or respiratory comorbidities, respectively. Ninety patients (94.7%) had a symptomatic SARS-CoV-2 infection. Seventy-five (79%) patients reported the persistence of symptoms after the end of the infection (negative swab), while 20 (21%) patients reported no symptoms. Among the former, 38 (50.7%) patients were symptomatic for ≤3 months and 37 (49.3%) were symptomatic for >3 months. In the hospitalized subgroup, 6 (100%) patients reported the persistence of COVID-19 symptoms, while this was reported by 69 (77.5%) patients in the non-hospitalized subgroup (p=ns).The clinical manifestations and their persistence after the infection are reported inFigure 1. The most common were cough and fatigue, which both lasted ≤3 months in 38 (42.2%) patients and >3 months in 3 (3.33%) and 21 (23.3%) patients, respectively. Headache (32 patients - 35.5%), arthralgias (28 patients - 31.1%), myalgias (27 patients - 30%) and shortness of breath (25 patients - 27.7%) were the most common symptoms that persisted in the first 3 months after the infection. Symptoms that persisted for >3 months in more than 20% of the patients were arthralgias (24 patients - 26.6%) and sleep disturbances (19 patients - 21.1%). However, it is difficult to assess whether arthralgias and myalgias were consequences of COVID-19 or secondary to the rheumatic disease. No COVID-19-related deaths were recorded.ConclusionOur data show the persistence of symptoms of COVID-19 after recovery in 79% of patients with chronic inflammatory arthritis. 49.3% of patients were symptomatic for >3 months. Cough, fatigue, headache, arthralgias, myalgias and shortness of breath were the most represented symptoms in the first 3 months after the infection, while arthralgias, fatigue, and sleep disturbances were the most reported after 3 months from SARS-CoV-2 infection.References[1]https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition updated: 7 Dec 2022[2]O'Mahoney LL et al. Lancet 2022Figure 1.Persistence of symptoms and signs after the end of SARS-CoV-2 infection.Data are represented as percentagesAcknowl dgements:NIL.Disclosure of InterestsNone Declared.
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BackgroundPenetrating injury of the oropharynx occurs frequently in children, however, anesthetic management is seldom described in such cases.Case presentationA 2-year old child came to the emergency room with a toothbrush impacted in the gingivobuccal sulcus making airway management difficult. We used a simple yet unique approach to secure the airway safely given the lack of pediatric size fibreoptic and videolaryngoscopes in our emergency operation theatre. The patient was kept in Pediatric ICU and watched for any complications and discharged on the 4th postoperative day.ConclusionsThus, ingenious non-invasive techniques to secure the airway can prevent the patient from undergoing surgical tracheostomy.
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Diagnostic error has recently become a crucial clinical problem and an area of intense research. However, the reality of diagnostic errors in regional hospitals remains unknown. This study aimed to clarify the reality of diagnostic errors in regional hospitals in Japan. A 10-month retrospective cohort study was conducted from January to October 2021 at the emergency room of Oda Municipal Hospital in central Shimane Prefecture, Japan. Participants were divided into groups with or without diagnostic errors, and independent variables of patient, physician, and environmental factors were analyzed using Fisher's exact test, univariate (Student's t-test and Welch's t-test), and logistic regression analyses. Diagnostic errors accounted for 13.1% of all eligible cases. Remarkably, the proportion of patients treated without oxygen support and the proportion of male patients were significantly higher in the group with diagnostic errors. Sex bias was present. Additionally, cognitive bias, a major factor in diagnostic errors, may have occurred in patients who did not require oxygen support. Numerous factors contribute to diagnostic errors; however, it is important to understand the trends in the setting of each healthcare facility and plan and implement individualized countermeasures.
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In the hospital nursery, a 4-week-old boy has creamy white patches on his lips, right and left buccal mucosa, palate, and tongue. He had been admitted to the nursery intensive care unit (NICU) 2 days ago. His mother brought him to the pediatric emergency department because he refused to feed and felt warm. Seven days previously, his mother received a diagnosis of COVID-19 infection. He had a sepsis work-up and was started on intravenous (IV) antibiotics.
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Additionally, they can treat atopic comorbidities such as atopic dermatitis, chronic urticaria, nasal polyps, eosinophilic esophagitis, and hypereosinophilic syndrome, resulting in improved quality of life for our patients. Parents should be made aware of its updated black box warning for possible effects on mental health and behavior changes,3 including but not limited to suicidal ideation. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair);advises restricting use for allergic rhinitis.
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SPECIAL REPORT Since the inception of the United States, social, economic, political, and scientific institutions have been built on a foundation emphasizing the inferiority of individuals related to phenotypic differences.1 This hierarchy ensconced white individuals as superior to all other groups with Native Americans and Blacks on the bottom. Some fifty years after the discovery of the genetic code, at a White House ceremony in 2000 to announce the discovery, Craig Venter, a pioneer of DNA sequencing, observed, "The concept of race has no genetic or scientific basis. With structural or institutional racism, there is decreased access to health care and resources for education, leading to lower health literacy and fewer health care providers of color.12'13 Over time, this has led to a distrust of the health care system as a whole by POC due to widely publicized historical events such as the Tuskegee Syphilis Study and the Marion tuberculosis outbreak. [...]non-Hispanic Blacks have a higher prevalence of recurrent asthma exacerbations and hospitalizations than Whites after adjusting for demographic and socioeconomic factors.16 One study revealed that with non-Black children, poor children were 45% more likely than children who were not poor to have asthma.
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Just as traumatic or stressful events and experiences can increase the risk, strong and supportive relationships and institutions can offset or mitigate that risk. [...]if mental health conditions do develop, early and ongoing recognition and treatment can decrease associated morbidity.2 4 The 2019-2020 National Survey of Children's Health showed that 23% of children aged 3 to 17 years have a reported mental, emotional, developmental, or behavioral (MEDB) problem, with prevalence unevenly distributed by geographic area and social determinants of health: Beginning in April 2020, the proportion of mental health-related visits in pediatric emergency departments increased significantly for both children and adolescents.8 A 2021 report from the Child Mind Institute, "The Impact of the COVID-19 Pandemic on Children's Mental Health: What We Know So Far," highlights the disproportionate negative impact on vulnerable children: those with preexisting mental health problems, especially those with limited access to treatment, racial minorities experiencing racism in the health care system and beyond, LGBTQ+ children, and families living with economic uncertainty or food insecurity.4 Skill-building resources To mitigate the level of need that has created the current crisis, it is particularly important that emerging mental health symptoms be recognized and addressed early within the pediatric medical home before they escalate to the level of crisis. [...]the AAP has developed a mental health toolkit for pediatricians that includes materials, real- world cases, tools for screening, video examples of skills, and an algorithm serving as a cognitive map for how to approach mental health concerns in an outpatient office setting.9 Another resource, The REACH Institute, offers live and online evidence-based training courses for pediatricians on identification and treatment of mental health issues, including screening, medication management, cognitive behavioral therapy, and a host of other topics, all patient-centered and designed to be feasible in an outpatient office setting.10 (For more on The REACH Institute and pediatrician training, see "Guiding principles in managing pediatric mental health issues," page 18.) Address the economic and social barriers that contribute to poor mental health foryoung people,families, and caregivers. 6 Increase timely data collection and research to identify and respond to youth mental health needs more rapidly.
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BackgroundThe novel coronavirus causes viral pneumonia characterized by lower respiratory tract symptoms and 19severe inflammatory response syndrome. Studies have suggested that the virus has a clinical course with the stepwise progression of clinical signs and symptoms and radiologic alterations.Case presentationIn the present case report, we discuss two patients who presented with mild symptoms and CT imaging not suggestive of COVID-19, but subsequently had a rapid deterioration, with severe involvement happening in CT imaging. One of the patients survived the initial deterioration, but the other passed away.ConclusionWe suggest that the clinical course of the virus may be rapidly progressive in some patients, and special attention should be paid to patients being treated for the virus outside of the hospital as an outpatient.
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Physician burnout has become a prevalent issue in intensive care units, and studies have shown it has become worse with the COVID-19 pandemic. Recognizing and reducing ICU physician burnout is important because of the potential effects on patient care, physician health, and the hospital. The most common symptoms of burnout include fatigue, callousness towards patients, inability to feel happy, anxiety, and depression. Causes of burnout can include work related factors, personal characteristics, and organizational factors. COVID has brought unprecedented work flow, increased number of critical and ethical decision making, and increase in death, all of which can lead to burnout. Strategies to combat burnout generally come in two different ways-organization based and individual based. This paper examines these current strategies and their efficacy in reducing burnout and proposes an implementation plan for the ICU to use based on current literature.
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Background and ImportanceIn Europe, the VITAE study estimates an annual incidence of venous thromboembolic disease (VTD) of 243/100,000 inhabitants.About 25% of VTD cases are related to hospital admissions and 50–75% of VTD cases occur in non-surgical hospitalised patients. PRETEMED is a validated thrombotic risk (TR) scale for clinical prediction that have been designed to be used in daily clinical practice. As well, it is recommended to assess the bleeding risk (BR) with another validated scale called IMPROVE scale before starting thromboprophylaxis (TP).Aim and ObjectivesDetermine the (TR/BR) and analyse whether the prescription of thromboprophylaxis in patients from the Emergency Department who are going to be admitted to the hospital ward is adequate.Material and MethodsProspective observational cohort study, carried out in a 2nd level hospital during a period of 10 days. Adult patients in the ED awaiting admission to the hospital ward were included.Patients with therapeutic effort limitation, COVID-19 patients, those who had been transfused in the last 48 hours, bleeding patients or those with underlying pathology that require anticoagulation were excluded. Using the PRETEMED/IMPROVE scales, the TR/BR was determined, as well as the indication of thromboprophylaxis.Results62 patients. 31 women (50%). The median age [range] was 71 [18–93] years. 31 patients with TP regimen, no interventions had to be performed, they had an adequate indication with PRETEMED> 4 and IMPROVE <7. 31 patients without TP regimen;7 (23%) of them had indication for TP and they went into the operating room with PRETEMED> 4 and IMPROVE <7. 7 (11.3%) of the patients required pharmaceutical intervention to adequate their TP, all of them by default.Conclusion and RelevanceThe prescription of TP in adults who visit the ED could be considered adequate in a high percentage, however it can be optimised according to the PRETEMED and IMPROVE guidelines. It is essential to recommend on the use of scales that assess TR/BR for the correct decision-making in the prescription of TP. The limitation of the study was the small sample size.References and/or AcknowledgementsConflict of InterestNo conflict of interest
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Hospitals continue to experience negative margins, with hospital expenses decreasing slightly since the start of the pandemic, but not enough to address impacted volumes and revenues. As a result, issues regarding hospital and health system debt and financial sustainability weigh heavily on health care admini - strators. Hospital finances, and specifically, the management of bonds and debt, are of vital concern, particularly in light of the elimination of CARES Act funding and the forthcoming expiration of the federal Public Health Emergency COVID-19 plan. In this article and accompanying podcast episode, Nursing Economics Editorial Board Member Dr. Therese Fitzpatrick talks with leading health care expert Lisa Goldstein, MPA, about the rising pressures to maintain financial sustainability as hospital margins react to post-pandemic admissions and related adjustments.
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[...]it may have been difficult to get him admitted since it is not our current practice to admit patients with mild COVID-19 infections. [...]our financial incentives are to see many patients each shift, which does not always leave time to care for more socially challenging cases. Burnout is rising in the field of emergency medicine, and I think a part of that burnout can be attributed to the uphill battle that providers are fighting daily to care for patients that our health system leaves behind.