A case series of diabetic ketoacidosis associated with SGLT2 inhibitors

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are increasingly initiated as treatment for type 2 diabetes due to favourable cardiorenal characteristics. However, studies have identified an increased risk of diabetic ketoacidosis (DKA). We carried out a retrospective, case-based study at East and North Herts NHS Trust between February 2018 and December 2020. Fifteen cases of SGLT2i associated DKA were identified in people with presumed type 2 diabetes;33.3% were classed as euglycaemic DKA with a blood glucose of <11mmol/L. All cases were associated with a significant precipitating factor including diarrhoea, vomiting, reduced oral intake and sepsis. One case was related to COVID-19. Two people were subsequently found to have raised islet autoantibodies suggesting type 1 diabetes or latent autoimmune diabetes in adults. It is important that awareness of SGLT2i associated DKA is raised among users and health care practitioners, including the recognition of euglycaemic DKA. Sick day rules should be emphasised and reiterated at clinical encounters. Non-specialists in primary care, oncology and in perioperative settings should be empowered to advocate for temporary withdrawal and there should be readier access to blood ketone monitoring when required. When SGLT2i associated DKA occurs, due consideration should be given to evaluate the diabetes classification and investigate the circumstances of the event. Copyright © 2023 John Wiley & Sons.Copyright © 2023 John Wiley & Sons, Ltd.

Child, adolescent, and parent mental health in general population during a year of COVID-19 pandemic in belgium: a cross-sectional study

Background: This study aims to evaluate the mental health status of children, adolescents and their parents during the first year of COVID-19 pandemic in Belgium. Method(s): Analysis compared results before and during the second national lockdown, which started on November 2nd 2020. A cross-sectional online survey was conducted between May 2020 and April 2021. Result(s): Two hundred and eighteen adults and 273 children fully completed the survey. Almost one in five children (17.9%) presented moderate-to-severe scores of depression. Adolescents presented a higher level of depression than children (p = 0.007). The rate of moderate-to-severe depression scores (10.8% to 21%, p = 0.007) and internalized symptoms increased during the second lockdown (p < 0.001). Parents' depression (p < 0.001) and anxiety (p = 0.027) levels also increased during the second lockdown. Logistic regression showed that the use of psychotropic medication in parents and parents' depression scores were risk factors for children to have worse depression scores. Conclusion(s): The second lockdown appears to worsen the effects of the pandemic on children's and parents' mental health. There is a need to implement specific interventions targeting both children/adolescents and their parents to support them during lockdown periods and improve mental health outcomes.Copyright © 2022, The Author(s).

SARS-COV-2 Infection in Children and Young People in Bulgaria - A Prospective, Single-Center, Cohort Study

Compared to other respiratory viruses, the proportion of hospitalizations due to SARS-CoV-2 among children is relatively low. While severe illness is not common among children and young individuals, a particular type of severe condition called multisystem inflammatory syndrome in children (MIS-C) has been reported. The aim of this prospective cohort study, which followed a group of individuals under the age of 19, was to examine the characteristics of patients who had contracted SARS-CoV-2, including their coexisting medical conditions, clinical symptoms, laboratory findings, and outcomes. The study also aimed to investigate the features of children who met the WHO case definition of MIS-C, as well as those who required intensive care. A total of 270 patients were included between March 2020 and December 2021. The eligible criteria were individuals between 0-18 with a confirmed SARS-CoV-2 infection at the Infectious Disease Hospital "Prof. Ivan Kirov"in Sofia, Bulgaria. Nearly 76% of the patients were <= 12 years old. In our study, at least one comorbidity was reported in 28.1% of the cases, with obesity being the most common one (8.9%). Less than 5% of children were transferred to an intensive care unit. We observed a statistically significant difference in the age groups, with children between 5 and 12 years old having a higher likelihood of requiring intensive care compared to other age groups. The median values of PaO2 and SatO2 were higher among patients admitted to the standard ward, while the values of granulocytes and C-reactive protein were higher among those transferred to the intensive care unit. Additionally, we identified 26 children who met the WHO case definition for MIS-C. Our study data supports the evidence of milder COVID-19 in children and young individuals as compared to adults. Older age groups were associated with higher incidence of both MIS-C and ICU admissions.Copyright © 2023 P. Velikov et al., published by Sciendo.

Changes in Kawasaki disease incidence and phenotype during the COVID-19 pandemic

INTRODUCTION. The aetiology of Kawasaki disease (KD) remains unknown. Changes in infectious exposure during the COVID-19 pandemic owing to infection prevention measures may have affected the incidence of KD, supporting the pathogenic role of an infectious trigger. The purpose of this study was to evaluate the incidence, phenotype and outcome of KD before and during the COVID-19 pandemic in Denmark. METHODS. This was a retrospective cohort study based on patients diagnosed with KD at a Danish paediatric tertiary referral centre from 1 January 2008 to 1 September 2021. RESULTS. A total of 74 patients met the KD criteria of whom ten were observed during the COVID-19 pandemic in Denmark. Alof these patients were negative for SARS-CoV-2 DNA and antibodies. A high KD incidence was observed during the first six months of the pandemic, but no patients were diagnosed during the following 12 months. Clinical KD criteria were equally met in both groups. The fraction of intravenous immunoglobulin (IVIG) non-responders was higher in the pandemic group (60%) than in the in the pre-pandemic group (28.3%), although the rate of timely administered IVIG treatment was the same in both groups (>= 80%). Coronary artery dilation was observed in 21.9% in the pre-pandemic group compared with 0% in KD patients diagnosed during the pandemic. CONCLUSION. Changes in KD incidence and phenotype were seen during the COVID-19 pandemic. Patients diagnosed with KD during the pandemic had complete KD, higher liver transaminases and significant IVIG resistance but no coronary artery involvement.Copyright © 2023, Almindelige Danske Laegeforening. All rights reserved.

Experiences of adult epilepsy patients with COVID-19 infections and vaccinations

Objective: To assess the course of COVID-19 infections and the tolerability of the mRNA vaccines of Moderna and Pfizer/BioNTech and the viral vector vaccines from Astra Zeneca and Johnson & Johnson in adult patients with epilepsy (PWE). Method(s): From July 2020 to July 2021, we consecutively included adult outpatients with confirmed epilepsy. These PWE were interviewed about COVID-19 infections and vaccinations. Results of follow-up visits were added until the cut-off date (December 31, 2021). The data of COVID-19-infected without vaccinations or fully vaccinated PWE without COVID-19 infections were analyzed. Full vaccination was defined as a double vaccination with the Pfizer/BionTech, Moderna, or Astra Zeneca vaccines or a single Johnson & Johnson vaccination. Result(s): At cut-off, 612 of 1152 PWE fulfilled the inclusion criteria: 51 PWE had been infected without vaccination and 561 had full vaccination without infection. Among the infected PWE, 76.5% presented with symptoms;9.8% had a severe course (one death). The leading symptoms were influenza-like disorders (48.7% of infected PWE with symptoms), anosmia (28.2%), and ageusia (20.5%). Seizure increases or relapses after sustained seizure freedom occurred in 7.8%. Adverse events (AEs) were reported by 113 vaccinated PWE (20.1% of all vaccinated PWE). The leading AEs were fatigue, fever, and headache. The AE rate per vaccine was 14.0% for Pfizer/BionTech, 32.7% for Moderna, 25.8% for Astra Zeneca, and 46.2% for Johnson & Johnson. Of the AEs, 93.3% lasted <=1 week. Seizure increase or relapse occurred in 1.4% and was significantly less frequent than in the infected group (p= 0.0016). Conclusion(s): The course of COVID-19 infections and the tolerability of the vaccines were similar as in the general population, yet, seizure worsening occurred more often after the infection than after the vaccination.Copyright © 2023, The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, part of Springer Nature.

Rapid exchange of a percutaneous gastrostomy tube during an early episode of COVID-19

We retrospectively report a case of rapid exchange of a percutaneous radiologic gastrostomy tube (balloon-occluded type catheter) via off-label use of a pigtail catheter for nutrition supply during a very early episode of coronavirus disease 2019 (COVID-19) in an outpatient clinic. This case demonstrates that minimally invasive percutaneous procedures might be provided safely and effectively under appropriate precautions for preventing COVID-19 transmission during the pandemic.Copyright © 2023, Society of Gastrointestinal Intervention.

Evaluation of the outcome of Covid-19 disease in patients under mechanical ventilation hospitalized in Al-Zahra Hospital, Isfahan in 2019.

Background: Coronavirus in 2019 was recognized as one of the leading causes of death worldwide. According to reports, the mortality rate in people who need mechanical ventilation varies from 50 to 97 percent. The aim of this study was to evaluate the outcome of Covid-19 disease based on different characteristics in patients and mechanically ventilated variables. Method(s): This descriptive-analytical study was conducted on 160 patients with a definite diagnosis of Covid-19 who were under mechanical ventilation and admitted to the intensive care unit of Alzahra Hospital in Isfahan from March 2020 to March 2021. Data was collected by checklist. The checklist included demographic information, including age, gender, as well as information such as underlying diseases, disease outcome, length of hospitalization, etc. After collecting the data, they were analyzed in SPSS software version 22 and at a significance level of less than 0.05. Result(s): In this study, the overall mortality rate among mechanically ventilated patients was 62.5%. The mean age of patients was 69.99+/-17.87 years and the mean duration of hospitalization in surviving patients was 15.47+/-11.73 days and for deceased ones was 55.21+/-69.14 days. The mean age of the deceased group (65.71+/-16.59) was significantly higher than the surviving group 53+/-21.17 was (P=0.0001). The length of hospital stay in the deceased group was significantly longer than the surviving group (P=0.005). As a result, ventilator mode and inotropic agent intake during treatment increased the chance of mortality in patients under mechanical ventilation (P=0.001). There was a significant relationship between underlying diseases of hypertension, kidney disease and autoimmune disease with mortality in patients (P<0.05). Conclusion(s): Various factors including the length of stay in the hospital, comorbidities such as hypertension, renal disease and autoimmunity may affect the outcome of critically ill ICU patients under mechanical ventilation. Patients who require long-term invasive ventilation and the use of inotropic drugs to maintain their cardiovascular status while hospitalized in the ICU are at higher risk for mortality.Copyright © 2022 Shetabi et al. Published by Tehran University of Medical Sciences.

Uptake of vaccination in older Indian patients with cancer: A cross-sectional observational study

Background: Older patients with cancer are at a higher risk of invasive infections. Vaccination is an effective approach to decrease the mortality and morbidity associated with infections. Objective(s): Our primary objective was to evaluate the proportion of older patients with cancer who had received routine vaccinations against pneumococcal, influenza, and coronavirus disease 2019 (COVID-19). Our secondary objective was to identify the factors associated with vaccine uptake such as age, sex, education, marital status, comorbidities, and place of residence. Material(s) and Method(s): This cross-sectional observational study was conducted in the geriatric oncology outpatient clinic of the Department of Medical Oncology at the Tata Memorial Hospital, a tertiary care cancer hospital in Mumbai, India, from February 2020 to January 2023. We included all patients aged >=60 years who were evaluated in the geriatric oncology clinic during the study period and for whom the immunization details were available. The uptake of COVID-19 vaccine was calculated from March 2021 onwards, which was when the COVID-19 vaccine became available to patients aged >=60 years in India. Result(s): We enrolled 1762 patients;1342 (76.2%) were male. The mean age was 68.4 (SD, 5.8) years;795 (45%) patients were from the west zone of India. Only 12 (0.68%) patients had received the pneumococcal vaccine, and 13 (0.7%) had received the influenza vaccine. At least one dose of the COVID-19 vaccine had been taken by 1302 of 1562 patients (83.3%). On univariate logistic regression, education, marital status, geographic zone of residence, and primary tumor site were correlated with the uptake of COVID-19 vaccine. Factors associated with a greater COVID-19 vaccine uptake included education (up to Std 10 and higher vs. less than Std 10: Odds Ratio [OR], 1.46;95% confidence interval [CI], 1.07-1.99;P = 0.018, and illiterate vs. less than Std 10: OR, 0.70;95% CI, 0.50-0.99;P = 0.041), marital status (unmarried vs. married: OR, 0.27;95% CI, 0.08-1.08;P = 0.046, and widow/widower vs. married: OR, 0.67;95% CI, 0.48-0.94;P = 0.017), lung and gastrointestinal vs. head-and-neck primary tumors (lung cancer vs. head-and-neck cancer: OR, 1.60;95% CI, 1.02-2.47;P = 0.038, and gastrointestinal vs.head-and-neck cancer: OR, 2.18;95% CI, 1.37-3.42;P < 0.001), and place of residence (west zone vs. central India: OR, 0.34;95% CI, 0.13-0.75;P = 0.015). Conclusion(s): Fewer than 1 in 100 older Indian patients with cancer receive routine immunization with influenza and pneumococcal vaccines. Hearteningly, the uptake of COVID-19 vaccination in older Indian patients with cancer is over 80%, possibly due to the global recognition of its importance during the pandemic. Similar measures as those used to increase the uptake of COVID-19 vaccines during the pandemic may be beneficial to increase the uptake of routine vaccinations.Copyright © 2023 Cancer Research, Statistics, and Treatment.

Getting the Most From FSP Model

Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions:

Anti-SARS-CoV-2 antibodies important in diagnostics of acute hepatitis in children

The most common causes of acute hepatitis in children are hepatitis A and autoimmune hepatitis. Hepatitis in the course of Wilson's disease is sporadically registered in adolescents. An increase of activity of aminotransferases both in the course of multisystem inflammatory syndrome in children (MIS-C) and in the course of COVID-19 has been observed. Hepatitis is common in children with MIS-C and is associated with a more severe presentation and persistent elevation of liver function tests. To date, no cases of acute hepatitis in children due to COVID-19 have been reported. We present 2 cases of acute hepatitis in children where the only cause seems to be a previous asymptomatic SARS-CoV-2 infection.Copyright © 2023 Termedia Publishing House Ltd.. All rights reserved.

COVID-19 vaccine uptake and vaccine hesitancy in Indian patients with cancer: A questionnaire-based survey

Background: Patients with cancer are at a higher risk of severe forms of coronavirus disease 2019 (COVID-19) and mortality. Therefore, widespread COVID-19 vaccination is required to attain herd immunity. Objective(s): We aimed to evaluate the uptake of the COVID-19 vaccine in Indian patients with cancer and to collect information regarding vaccine hesitancy and factors that contributed to vaccine hesitancy. Material(s) and Method(s): This was a questionnaire-based survey conducted between May 7, 2021 and June 10, 2021 in patients aged 45 years and over, with solid tumors. The primary end points of the study were the proportion of Indian patients with cancer aged 45 years and older who had not received the COVID-19 vaccine, and the reasons why these patients had not received the COVID-19 vaccine. Our secondary end points were the proportion of patients with a history of COVID-19 infection, and the proportion of the patients who had vaccine hesitancy. Additionally, we attempted to assess the factors that could impact vaccine hesitancy. Result(s): A total of 435 patients were included in the study. Of these, 348 (80%) patients had not received even a single dose of the COVID-19 vaccine;66 (15.2%) patients had received the first dose, and 21 (4.8%) had received both the doses. Approximately half (47.1%) of the patients reported that they took the COVID-19 vaccine based on the advice from a doctor. The reasons for not taking the COVID-19 vaccine could be considered as vaccine hesitancy in 259 (77%) patients. The two most common reasons were fear in 124 (38%) patients (fear of side-effects and of the impact of the vaccine on the cancer/therapy) and lack of information in 87 (26.7%) patients. On the multivariate analysis, the two factors found to be significantly associated with vaccine hesitancy were a lower educational level (OR, 1.78;95% CI, 1-3.17;P = 0.048) and a lack of prior advice regarding the COVID-19 vaccine (OR, 2.80;95% CI, 1.73-4.53;P < 0.001). Conclusion(s): Vaccine hesitancy is present in over half of our patients, and the most common reasons are a fear of the vaccine impacting the cancer therapy, fear of side-effects, and lack of information. Widespread vaccination can only be attained if systematic programs for education and dissemination of information regarding the safety and efficacy of the COVID-19 vaccine are given as much importance as fortification of the vaccination supply and distribution system.Copyright © 2021 Cancer Research, Statistics, and Treatment Published by Wolters Kluwer - Medknow.

Should Young Covid-19 Patients be Suplemented with Vitamin D?

It is well known that vitamin D's general immunomodulatory actions are helpful in viral infections and that a shortage is linked to a more serious prognosis for Covid-19. In this sistematic review, we examined the existing literature on evidence as to whether there is also link between vitamin D range levels in pediatric population and the outcome of the Covid-19 infection. We looked for studies that measured vitamin D blood concentrations and examined the effects of vitamin D supplementation in young infected patients. Vitamin D may decrease the risk of respiratory infections in a number of ways through its interactions with numerous cells, including by decreasing viral survival and replication, reducing the cytokine storm, raising angiotensin-converting enzyme 2 concentrations (ACE2) while not damaging the endothelial integrity. The incidence or severity of Covid-19 is linked with blood 25-hydroxyvitamin D concentrations, according to many observational studies. However experimental verification is still needed. Given their safety and broad therapeutic window, vitamin D supplements seem to be an effective way for individuals and doctors to prevent or treat Covid-19. Nonetheless, the outcomes of significant vitamin D randomized controlled trials are further needed.Copyright © 2022 Maria Nicolae et al., published by Sciendo.

Correlation Between the Suitability of Empirical and Definitive Therapies According to Culture Results with the Clinical Outcomes of Patients with Bacteremia Due to Carbapenem- Resistant Acinetobacter baumannii (CRAB) at Dr. Soetomo Tertiary Referral Hospital

Carbapenem administration is an important therapy for nosocomial infections due to MDRO, especially Acinetobacter baumannii. The global increase in carbapenem-resistant A. baumannii (CRAB) that causes this pathogen has significantly threatened public health due to the lack of adequate treatment options due to the very few currently available antimicrobial agents that actively fight CRAB. Antimicrobial resistance is a major negative impact of inappropriate antimicrobial prescribing. Ineffective empiric treatment (initial antibiotic regimen not sensitive to identified pathogens based on in vitro sensitivity test results) is associated with a higher rate of deaths compared to effective empiric treatment. In this study, we analyzed the correlation between the suitability of empiric and definitive antibiotics and the clinical outcomes of patients with bacteremia due to CRAB treated in the inpatient ward of Dr. Soetomo Tertiary Referral Hospital, Surabaya. There were 227 isolates of bacteremia due to CRAB, consisting of 156 carbapenem-resistant A. baumanni and 71 carbapenem-sensitive A. baumannii. There were 88 isolates that met the inclusion and exclusion criteria, and all of them were resistant to ceftriaxone, cefepime, and ciprofloxacin. A total of 29.5% of the isolates were sensitive to cotrimoxazole, 3.4% of the isolates were sensitive to tigecycline, and 2.3% of the isolates were sensitive to amikacin, levofloxacin, and cefoperazone sulbactam. Adequate empirical antibiotics and definitive antibiotics (sensitive based on culture sensitivity test) amounted to 12.5% and 27.3%, respectively. There is no significant correlation between the suitability of empiric and definitive therapies with the patients' clinical outcomes (death and length of stay).Copyright © 2022 Phcogj.Com.

COVID-19 Vaccination Hesitancy Among 5-11-year-old Iranian Children's Parents: What Are Underlying Beliefs?

Background: Of all teenage deaths caused by coronavirus disease 2019 (COVID-19), 47% occurred in children aged 0-9. Like many other infectious diseases, reducing mortality in children requires widespread vaccination. Despite the availability of the COVID-19 vaccine, a large percentage of children have not received the vaccine. Objective(s): This survey aimed to study parents' reluctance to receive the COVID-19 vaccine for their children in Shiraz, Iran. Method(s): An online questionnaire was sent to parents whose 5 to 11-year-old children had received no COVID-9 vaccine through the health educators of primary schools in Shiraz, Iran. The questionnaire contained demographic questions and 16 beliefs about COVID-19 vaccination that were answered as yes/no. Result(s): We assessed 1093 respondents, including 49.5% (n = 542) male and 50.5% female students' parents. The mean number of wrong beliefs was 7.21 +/- 2.80 in parents who had boys and 7.78 +/- 2.95 in girls' parents. Also, 78.6% of participants had at least five wrong beliefs or excuses for not vaccinating their children. Notably, 82.8% of mothers and 84.3% of fathers were vaccinated with 2-3 doses against COVID-19. The most common wrong beliefs were probable vaccines' side effects in the future, the undesirable effect of vaccination on children's growth, and the awful effect of the vaccine on fertility, with a prevalence of 82.7%, 81.2%, and 76.7%, respectively. Conclusion(s): This study identified that most participants believed that COVID-19 vaccines have side effects for their children and unfavorable effects on children's growth and infertility.Copyright © 2023, Author(s).

COVID-19 Stresses EMA Resources

EMA has pleaded with the European Commission (EC) for more funds to finance the costs of its increased duties (2). "The GMP standards will be applied to the manufacture of sterile vials for the vaccines as per standard requirements, regardless of location," said a spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, where a COVID-19 vaccine being jointly developed by AstraZeneca and Oxford University is considered likely to be among the first to gain authorization for mass distribution. Manufacturers of vaccines and their containers could be subject to two waves of standards-checking inspections- one for GMP and the other for pharmacovigilance. Because the latter will be the most extensive covering, for example, requiring surveillance quality systems in all the operations of a business, a manufacturer that is considered to be compliant with pharmacovigilance standards is unlikely to be breaching GMP rules. Other priorities include the work of key working parties and groups, drawing up of certain guidelines, the fight against anti-microbial resistance (AMR), co-operation with health technology assessment (HTA) bodies, innovation (especially in emerging therapies), clinical data publication, and international co-operation.

Report of the Association Between Multisystem Inflammatory Syndrome and Severe Myocarditis

Introduction: The people worldwide have been affected by severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) infection since its appearance in December, 2019. Kawasaki disease-like hyperinflammatory shock associated with SARS-CoV-2 infection in previously healthy children has been reported in the literature, which is now referred to as a multisystem inflammatory syndrome in children (MIS-C). Some aspects of MIS-C are similar to those of Kawasaki disease, toxic shock syndrome, secondary hemophagocytic syndrome, and macrophage activation syndrome. Case Presentation: This study reported an 11-year-old boy with MIS-C presented with periorbital and peripheral edema, abdominal pain, elevated liver enzymes, severe right pleural effusion, moderate ascites, and severe failure of right and left ventricles. Conclusion(s): Due to the increasing number of reported cases of critically ill patients afflicted with MIS-C and its life-threatening complications, it was recommended that further studies should be carried out in order to provide screening tests for myocardial dysfunction. Adopting a multidisciplinary approach was found inevitable.Copyright © 2023, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.

COVID-19 Incidence and its Clinical Course in Liver Transplant Recipients.

Organ transplant recipients receive immunosuppressive drugs and hence are at high risk for COVID-19 due to their compromised immunity. This study assessed 1,370 liver transplant recipients who were followed at our hospital. A total of 12 patients got COVID-19: 5 recipients <50-years-old had mild disease, 7 recipients >60-years-old had moderate to severe disease, and 2 patients died. In addition, not all patients received 2 vaccinations, suggesting that the immunization is important for COVID-19 prophylaxis even in this patient population. One recipient was successfully treated with a combination of a reduced dose of immunosuppressive drugs, dexamethasone, remdesivir, and antibiotics, which is being established as an effective therapy for COVID-19.Copyright © 2022 The Japan Society of Hepatology.

SARS-CoV-2 infection (COVID-19) in children.

Since the outbreak in December 2019, the SARS-CoV-2 pandemic virus has been a major public health problem in all countries of the world. The virus is transmitted by inhalation of respiratory droplets from the patient or asymptomatic carrier and is highly contagious. The clinical disease in children is similar to any acute respiratory infection with predominant upper respiratory symptoms, but occasionally can progress to pneumonia with acute respiratory distress syndrome and multiorgan failure. The disease is milder in children than in adults, with low mortality, and it appears that infants and young children have a somewhat more severe clinical course. Diagnosis is made by detecting the virus from respiratory samples (mainly nasopharyngeal and oropharyngeal swabs) using polymerase chain reaction. Treatment is usually symptomatic, and in severe and critical forms, the use of one of the antiviral drugs (lopinavir-ritonavir, remdesivir, hydroxychloroquine) may be consideredCopyright © 2020 Croatian Paediatric Society. All rights reserved.

Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk: An International Journal of Medical Toxicology and Drug Experience

Introduction Identifying individual characteristics or underlying conditions linked to adverse drug reactions (ADRs) can help optimise the benefit-risk ratio for individuals. A systematic evaluation of statistical methods to identify subgroups potentially at risk using spontaneous ADR report datasets is lacking. Objectives In this study, we aimed to assess concordance between subgroup disproportionality scores and European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) discussions of potential subgroup risk. Methods The subgroup disproportionality method described by Sandberg et al., and variants, were applied to statistically screen for subgroups at potential increased risk of ADRs, using data from the US FDA Adverse Event Reporting System (FAERS) cumulative from 2004 to quarter 2 2021. The reference set used to assess concordance was manually extracted from PRAC minutes from 2015 to 2019. Mentions of subgroups presenting potential differentiated risk and overlapping with the Sandberg method were included. Results Twenty-seven PRAC subgroup examples representing 1719 subgroup drug-event combinations (DECs) in FAERS were included. Using the Sandberg methodology, 2 of the 27 could be detected (one for age and one for sex). No subgroup examples for pregnancy and underlying condition were detected. With a methodological variant, 14 of 27 examples could be detected. Conclusions We observed low concordance between subgroup disproportionality scores and PRAC discussions of potential subgroup risk. Subgroup analyses performed better for age and sex, while for covariates not well-captured in FAERS, such as underlying condition and pregnancy, additional data sources should be considered.