COVID-19 Vaccine Injury Compensation Program: Lessons Learned From a Review of 10 Implementing Countries.

National vaccine injury compensation serves as a crucial and significant safety net for individuals affected by government-recommended vaccines during a pandemic, contributing to the community's overall safety. In the Republic of Korea, compensation for adverse events resulting from coronavirus disease 2019 (COVID-19) vaccinations has been provided through the National Vaccine Injury Compensation Program introduced in 1995. However, there have been limitations with these measures during the COVID-19 pandemic owing to strict criteria for substantiating causality between the vaccine and injury, its nontransparent process of determining whether to compensate, and the compensation amount that is not practically calculated. This article reviewed the Vaccine Injury Compensation Programs in 10 major countries to present implications for improving the Korean system. Expanding the scope of national accountability is essential to compensate for the consequences of adhering to national policies during public health crises. Therefore, valuable insight can be obtained from examining the systems in Germany, Japan, and Taiwan, which have implemented more relaxed criteria for determining causality in compensation cases; Thailand's system, which provides the mandatory payment of preliminary compensation for damage caused by vaccination; systems in Germany, France, and Japan, which offer compensation for vaccine injuries from a practical perspective; and systems in France and the United Kingdom, which have a process allowing the assessment records to be shared with the claimants. Furthermore, a dedicated agency for vaccine injury compensation, as seen in France, the United Kingdom, and Australia, is necessary to enhance the efficiency of the Korean system.

Lower vs Higher Oxygenation Target and Days Alive Without Life Support in COVID-19: The HOT-COVID Randomized Clinical Trial.

Importance: Supplemental oxygen is ubiquitously used in patients with COVID-19 and severe hypoxemia, but a lower dose may be beneficial. Objective: To assess the effects of targeting a Pao2 of 60 mm Hg vs 90 mm Hg in patients with COVID-19 and severe hypoxemia in the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized clinical trial including 726 adults with COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 11 ICUs in Europe from August 2020 to March 2023. The trial was prematurely stopped prior to outcome assessment due to slow enrollment. End of 90-day follow-up was June 1, 2023. Interventions: Patients were randomized 1:1 to a Pao2 of 60 mm Hg (lower oxygenation group; n = 365) or 90 mm Hg (higher oxygenation group; n = 361) for up to 90 days in the ICU. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (mechanical ventilation, circulatory support, or kidney replacement therapy) at 90 days. Secondary outcomes included mortality, proportion of patients with serious adverse events, and number of days alive and out of hospital, all at 90 days. Results: Of 726 randomized patients, primary outcome data were available for 697 (351 in the lower oxygenation group and 346 in the higher oxygenation group). Median age was 66 years, and 495 patients (68%) were male. At 90 days, the median number of days alive without life support was 80.0 days (IQR, 9.0-89.0 days) in the lower oxygenation group and 72.0 days (IQR, 2.0-88.0 days) in the higher oxygenation group (P = .009 by van Elteren test; supplemental bootstrapped adjusted mean difference, 5.8 days [95% CI, 0.2-11.5 days]; P = .04). Mortality at 90 days was 30.2% in the lower oxygenation group and 34.7% in the higher oxygenation group (risk ratio, 0.86 [98.6% CI, 0.66-1.13]; P = .18). There were no statistically significant differences in proportion of patients with serious adverse events or in number of days alive and out of hospital. Conclusion and Relevance: In adult ICU patients with COVID-19 and severe hypoxemia, targeting a Pao2 of 60 mm Hg resulted in more days alive without life support in 90 days than targeting a Pao2 of 90 mm Hg. Trial Registration: ClinicalTrials.gov Identifier: NCT04425031.

Allograft function predicts mortality in kidney transplant recipients with severe COVID-19: a paradoxical risk factor.

Introduction: Kidney transplant recipients (KTRs) are at a higher risk of severe coronavirus disease (COVID-19) because of their immunocompromised status. However, the effect of allograft function on the prognosis of severe COVID-19 in KTRs is unclear. In this study, we aimed to analyze the correlation between pre-infection allograft function and the prognosis of severe COVID-19 in KTRs. Methods: This retrospective cohort study included 82 patients who underwent kidney transplantation at the Sichuan Provincial Peoples Hospital between October 1, 2014 and December 1, 2022 and were diagnosed with severe COVID-19. The patients were divided into decreased eGFR and normal eGFR groups based on the allograft function before COVID-19 diagnosis (n=32 [decreased eGFR group], mean age: 43.00 years; n=50 [normal eGFR group, mean age: 41.88 years). We performed logistic regression analysis to identify risk factors for death in patients with severe COVID-19. The nomogram was used to visualize the logistic regression model results. Results: The mortality rate of KTRs with pre-infection allograft function insufficiency in the decreased eGFR group was significantly higher than that of KTRs in the normal eGFR group (31.25% [10/32] vs. 8.00% [4/50], P=0.006). Pre-infection allograft function insufficiency (OR=6.96, 95% CI: 1.4633.18, P=0.015) and maintenance of a mycophenolic acid dose >1500 mg/day before infection (OR=7.59, 95% CI: 1.0853.20, P=0.041) were independent risk factors, and the use of nirmatrelvir/ritonavir before severe COVID-19 (OR=0.15, 95% CI: 0.030.72, P=0.018) was a protective factor against death in severe COVID-19. Conclusions: Pre-infection allograft function is a good predictor of death in patients with severe COVID-19. Allograft function was improved after treatment for severe COVID-19, which was not observed in patients with non-severe COVID-19.

High-flow nasal oxygen versus conventional oxygen therapy and noninvasive ventilation in COVID-19 respiratory failure: a systematic review and network meta-analysis of randomised controlled trials.

BACKGROUND: Noninvasive methods of respiratory support, including noninvasive ventilation (NIV), continuous positive airway pressure (CPAP), and high-flow nasal oxygen (HFNO), are potential strategies to prevent progression to requirement for invasive mechanical ventilation in acute hypoxaemic respiratory failure. The COVID-19 pandemic provided an opportunity to understand the utility of noninvasive respiratory support among a homogeneous cohort of patients with contemporary management of acute respiratory distress syndrome. We performed a network meta-analysis of studies evaluating the efficacy of NIV (including CPAP) and HFNO, compared with conventional oxygen therapy (COT), in patients with COVID-19. METHODS: PubMed, Embase, and the Cochrane library were searched in May 2023. Standard random-effects meta-analysis was used first to estimate all direct pairwise associations and the results from all studies were combined using frequentist network meta-analysis. Primary outcome was treatment failure, defined as discontinuation of HFNO, NIV, or COT despite progressive disease. Secondary outcome was mortality. RESULTS: We included data from eight RCTs with 2302 patients, (756 [33%] assigned to COT, 371 [16%] to NIV, and 1175 [51%] to HFNO). The odds of treatment failure were similar for NIV (P=0.33) and HFNO (P=0.25), and both were similar to that for COT (reference category). The odds of mortality were similar for all three treatments (odds ratio for NIV vs COT: 1.06 [0.46-2.44] and HFNO vs COT: 0.97 [0.57-1.65]). CONCLUSIONS: Noninvasive ventilation, high-flow nasal oxygen, and conventional oxygen therapy are comparable with regards to treatment failure and mortality in COVID-19-associated acute respiratory failure. PROSPERO REGISTRATION: CRD42023426495.

Successful salvage of a severe COVID-19 patient previously with lung cancer and radiation pneumonitis by mesenchymal stem cells: a case report and literature review.

During the COVID-19 pandemic, elderly patients with underlying condition, such as tumors, had poor prognoses after progressing to severe pneumonia and often had poor response to standard treatment. Mesenchymal stem cells (MSCs) may be a promising treatment for patients with severe pneumonia, but MSCs are rarely used for patients with carcinoma. Here, we reported a 67-year-old female patient with lung adenocarcinoma who underwent osimertinib and radiotherapy and suffered from radiation pneumonitis. Unfortunately, she contracted COVID-19 and that rapidly progressed to severe pneumonia. She responded poorly to frontline treatment and was in danger. Subsequently, she received a salvage treatment with four doses of MSCs, and her symptoms surprisingly improved quickly. After a lung CT scan that presented with a significantly improved infection, she was discharged eventually. Her primary disease was stable after 6 months of follow-up, and no tumor recurrence or progression was observed. MSCs may be an effective treatment for hyperactive inflammation due to their ability related to immunomodulation and tissue repair. Our case suggests a potential value of MSCs for severe pneumonia that is unresponsive to conventional therapy after a COVID-19 infection. However, unless the situation is urgent, it needs to be considered with caution for patients with tumors. The safety in tumor patients still needs to be observed.

Charting a path forward: Promising outcomes of convalescent plasma therapy in the care of severely B-cell depleted patients with persistent COVID-19.

BACKGROUND: Patients with severe B-cell depletion related to hematological malignancies or B-cell targeted therapy suffer from impaired antibody responses to SARS-CoV-2 and are at risk for prolonged COVID-19. In this population, COVID-19 convalescent plasma (CCP) may provide passive immunity, enhance immune response, and promote virus neutralization. This study evaluated outcomes of B-cell depleted patients with persistent COVID-19 treated with CCP. STUDY DESIGN AND METHODS: This analysis included all consecutive severely B-cell depleted patients with persistent COVID-19, receiving CCP at Rambam between 01.2022-02.2023. Persistent COVID-19 was defined as the presence of symptoms for ≥14 days in patients with negative SARS-CoV-2 nucleocapsid antibody test results. RESULTS: Twenty patients met inclusion criteria, 17 of whom had hematological malignancies, two suffered from rheumatoid arthritis and one had both. Twelve patients received anti-CD-20 treatment, one - CAR-T cells and three underwent stem cell transplantation. The median duration of COVID-19 symptoms was 27.5 days (range 14-97); 12 patients had mild-to-moderate COVID-19 and 8 had severe infection. Sixteen patients required hospitalization. The majority of patients received other COVID-19 therapies before CCP. Within a median of two days (range 1-16) post-infusion, 19/20 patients clinically improved. No CCP-associated adverse events were documented. COVID-19 symptoms recurred in 3 of the improved patients. Two patients died from COVID-19 on days 1 and 90 following the first CCP infusion. DISCUSSION: In severely B-cell depleted patients with persistent COVID-19, CCP is safe and associated with rapid clinical improvement. This subset of immunocompromised patients could particularly benefit from CCP administration.

COVID-19 Outcomes and Vaccinations in Swedish Solid Organ Transplant Recipients 2020-2021: A Nationwide Multi-Register Comparative Cohort Study.

Increased COVID-19-related morbidity and mortality have been reported in solid organ transplant recipients (SOTRs). Most studies are underpowered for rigorous matching. We report infections, hospitalization, ICU care, mortality from COVID-19, and pertinent vaccination data in Swedish SOTRs 2020-2021. We conducted a nationwide cohort study, encompassing all Swedish residents. SOTRs were identified with ICD-10 codes and immunosuppressant prescriptions. Comparison cohorts were weighted based on a propensity score built from potential confounders (age, sex, comorbidities, socioeconomic factors, and geography), which achieved a good balance between SOTRs and non-SOTR groups. We included 10,372,033 individuals, including 9073 SOTRs. Of the SARS-CoV-2 infected, 47.3% of SOTRs and 19% of weighted comparator individuals were hospitalized. ICU care was given to 8% of infected SOTRs and 2% of weighted comparators. The case fatality rate was 7.7% in SOTRs, 6.2% in the weighted comparison cohort, and 1.3% in the unweighted comparison cohort. SOTRs had an increased risk of contracting COVID-19 (HR = 1.15 p < 0.001), being hospitalized (HR = 2.89 p < 0.001), receiving ICU care (HR = 4.59 p < 0.001), and dying (HR = 1.42 p < 0.001). SOTRs had much higher morbidity and mortality than the general population during 2020-2021. Also compared with weighted comparators, SOTRs had an increased risk of contracting COVID-19, being hospitalized, receiving ICU care, and dying. In Sweden, SOTRs were vaccinated earlier than weighted comparators. Lung transplant recipients had the worst outcomes. Excess mortality among SOTRs was concentrated in the second half of 2021.

Clinical characteristics and outcomes of allogeneic hematopoietic stem cell transplantation recipients with coronavirus disease 2019 caused by the Omicron variant: a prospective, observational cohort study.

We aimed to describe the clinical characteristics, particularly the occurrence and risk factors of severe/critical illness, in allogeneic hematopoietic stem cell (allo-HSCT) recipients infected with coronavirus disease 2019 (COVID-19) caused by Omicron variant in an observational prospective study (n = 311). The median time from allo-HSCT to COVID-19 diagnosis was 8.5 months (range 0.8-106.1) months. Four patients (1.3%) were reported to be asymptomatic during Omicron variant infection, and 135 (43.4%) patients showed lower respiratory tract disease. Thirty-four (10.9%) patients were categorized into serious infection (severe illness n = 25; critical illness n = 9) and the median duration from COVID-19 diagnosis to serious infections was 6 days (range, 0-29) days. Thirteen (4.2%) and 6 (1.9%) patients required intensive care unit care and invasive mechanical ventilation, respectively. Receiving more than 1 type of immunosuppressive therapies at COVID-19 diagnosis was associated with severity and persistence of infection. Six patients (1.9%) died after diagnosis of COVID-19 infection. The 4-week probability of overall survival after COVID-19 diagnosis was 98.7%, which was 100% and 88.2% for non-serious and serious infection group (P < 0.001), respectively. Thus, we observed a relatively low serious infection and mortality rate in allo-HSCT recipients infected with COVID-19 caused by Omicron variant.

H. Pylori Treatment in the COVID-19 Era. What Have We Learned So Far?

PURPOSE OF REVIEW: CoronaVirus Disease of 2019 (COVID-19) has negatively influenced the management of multiple conditions in regards to the gastroenterology patient. An equivalent change in the management of Helicobacter pylori (H. pylori)-related diseases was reported, as practically no eradication treatment was offered during most of the pandemic. Given the scarcity of published data, we performed a literature review trying to elucidate the effect of COVID-19 on H. pylori treatment. RECENT FINDINGS: COVID-19 has produced more questions than answers as to the outcome of COVID-19 in H. Pylori infected patients, post-COVID-19 patients treated for H. pylori, acid suppression and COVID-19 incidence and outcomes, and H. pylori eradication treatment in patients having recovered from COVID-19. We strongly believe that this scientific uncertainty produced by the COVID-19 pandemic has set up the stage for an incremental change in H. pylori treatment as COVID-19 has offered us the chance to speed up how we will, in the near future, approach patients with a possible Η. pylori infection.

Australian health care workers experience of PPE related side-effects. A cross-sectional survey.

Introduction: Protection of health care workers (HCWs) is a fundamental aspect of an effective pandemic response. During the COVID-19 pandemic, frequency, and duration of Personal Protective Equipment (PPE) use increased. The experience of PPE-related side-effects has potential to contribute to decreased compliance resulting in breaches in infection prevention and increasing risk of HCW exposure. This study aims were to measure the frequency of PPE-related side-effects amongst HCW in Australia, and to establish if an increased frequency of adverse reactions was related to the significant increase in use and extended duration of time spent in PPE. Methods: A descriptive cross-sectional survey was used. Results: Of the 559 respondents the majority were female (83.7%), aged 31-45 years old (33.6%). A pre-existing skin condition was reported by 266 (47.6%). Frequency of PPE related side-effects were: pressure-related 401 (71.7%), skin 321 (57.4%) and respiratory 20 (3.6%). Surgical mask use was significantly associated with pre-exiting skin conditions (ß = 1.494 (SE 0.186), df (1), p < 0.001). Side effects to N95 respirator use was more commonly reported by staff working in COVID-19 high-risk areas (ß = 0.572 (SE 0.211), df (1), p = 0.007) independent of work duration (ß = -0.056 (SE 0.075), df (1), p = 0.456), and pre-existing skin conditions (ß = 1.272, (SE.198), df (1), p < 0.001). Conclusion: The COVID-19 pandemic has seen a significant increase in the use of PPE. While the preventative benefits of PPE are significant, adverse events related to PPE use are frequently reported by HCW. Findings in this study highlight the need for innovation in PPE design to maximize protection while decreasing adverse effects and maintaining adhere to use.

Evaluation of organ dose using size-specific dose estimation (SSDE) and related cancer risk due to chest CT scan during the COVID-19 pandemic.

This study aimed to estimate lung and breast doses for individual patients using the size-specific dose estimate (SSDE) method, as well as calculating effective doses, in patients who underwent chest CT scans during the COVID-19 pandemic. Cancer risk incidence was estimated using excess relative risk (ERR), excess absolute risk (EAR), and lifetime attributable risk (LAR) models from the Biological Effects of Ionizing Radiation Report VII (BEIR-VII). Data from about 570 patients who underwent CT scans for COVID-19 screening were utilized for this study. Using the header of the CT images in a Python script, SSDE and effective dose were calculated for each patient. The SSDE obtained by water equivalent effective diameter (wSSDE) was considered as lung and breast dose, and applied in organ-specific cancer risk estimation. The mean wSSDE value for females (13.3 mGy) was slightly higher than that for males (13.1 mGy), but the difference was not statistically significant (P value = 0.41). No significant differences were observed between males and females in terms of calculated EAR and ERR for lung cancer at 5 and 30 years after exposure (P value = 0.47, 0.46, respectively). Similarly, there was no significant difference in lung cancer LAR values between females and males (P value = 0.48). The results also indicated a decrease in LAR values for both lung and breast cancers with increasing exposure age. In accordance with the ALARA (as low as reasonably achievable) principle, it is important for medical staff and the general public to consider the benefits of CT imaging in detecting such infections. Additionally, imaging medical physicists and CT scan experts should optimize imaging protocols and strike a balance between image quality for detecting abnormalities and radiation dose, all while adhering to the ALARA principle.

Hydroxychloroquine and COVID-19 story: is the low-dose treatment the missing link? A comprehensive review and meta-analysis.

Hydroxychloroquine (HCQ) has been repurposed and used for the treatment of COVID-19 patients; however, its efficacy remains controversial, maybe partly due to the dosage, ranging from 200 to 800 mg/day, reported in different studies. Indeed, HCQ low dose (≤ 2.4 g/5 days) showed a lower risk of side effects compared to high doses. In this study, we performed a systematic review and meta-analysis to investigate the effect of low-dose HCQ used alone on three outcomes including in-hospital mortality, the need for mechanical ventilation, and ICU admission in COVID-19 patients. A systematic review of English literature was conducted from January 2020 to April 2022, in PubMed, Cochrane Library, and Google Scholar. Studies reporting a dosage of 400 mg twice the first day, followed by 200 mg twice for four days were included. Pooled odds ratios and 95% confidence intervals were calculated using random-effects models. Eleven studies (12,503 patients) were retained in the quantitative analysis, four observational cohort studies, and seven RCTs. When pooling both observational and RCTs, low-dose HCQ was associated with decreased mortality (OR = 0.73, 95% CI: [0.55-0.97], I2 = 58%), but not with mechanical ventilation need (OR = 1.03, 95% CI: [0.56-1.89], I2 = 67%) and ICU admission rate (OR = 0.70, 95% CI: [0.42-1.17], I2 = 47%). However, no effect was observed when pooling only RCTs. Despite RCTs limitations, treatment with low-dose HCQ was not associated with improvement in mortality, mechanical ventilation need and ICU admission rate in COVID-19 patients.

Observational study of the effect of ketamine infusions on sedation depth, inflammation, and clinical outcomes in mechanically ventilated patients with SARS-CoV-2.

Severely ill patients with COVID-19 are challenging to sedate and often require high-dose sedation and analgesic regimens. Ketamine can be an effective adjunct to facilitate sedation of critically ill patients but its effects on sedation level and inflammation in COVID-19 patients have not been studied. This retrospective, observational cohort study evaluated the effect of ketamine infusions on inflammatory biomarkers and clinical outcomes in mechanically ventilated patients with SARS-CoV-2 infection. A total of 186 patients were identified (47 received ketamine, 139 did not). Patients who received ketamine were significantly younger than those who did not (mean (standard deviation) 59.2 (14.2) years versus 66.3 (14.4) years; P = 0.004), but there was no statistically significant difference in body mass index (P = 0.25) or sex distribution (P = 0.91) between groups. Mechanically ventilated patients who received ketamine infusions had a statistically significant reduction in Richmond Agitation-Sedation Scale score (-3.0 versus -2.0, P < 0.001). Regarding inflammatory biomarkers, ketamine was associated with a reduction in ferritin (P = 0.02) and lactate (P = 0.01), but no such association was observed for C-reactive protein (P = 0.27), lactate dehydrogenase (P = 0.64) or interleukin-6 (P = 0.87). No significant association was observed between ketamine administration and mortality (odds ratio 0.971; 95% confidence interval 0.501 to 1.882; P = 0.93). Ketamine infusion was associated with improved sedation depth in mechanically ventilated COVID-19 patients and provided a modest anti-inflammatory benefit but did not confer benefit with respect to mortality or intensive care unit length of stay.

The association of post-embryo transfer SARS-CoV-2 infection with early pregnancy outcomes in in vitro fertilization: a prospective cohort study.

BACKGROUND: The influence of SARS-CoV-2 infection after embryo transfer on early pregnancy outcomes in in vitro fertilization or intracytoplasmic sperm injection-embryo transfer treatment remains inadequately understood. This knowledge gap endures despite an abundance of studies investigating the repercussions of preceding SARS-CoV-2 infection on early pregnancy outcomes in spontaneous pregnancies. OBJECTIVE: This study aimed to investigate the association between SARS-CoV-2 infection within 10 weeks after embryo transfer and early pregnancy outcomes in patients undergoing in vitro fertilization/intracytoplasmic sperm injection treatment. STUDY DESIGN: This prospective cohort study was conducted at a single public in vitro fertilization center in China. Female patients aged 20 to 39 years, with a body mass index ranging from 18 to 30 kg/m2, undergoing in vitro fertilization/intracytoplasmic sperm injection treatment, were enrolled between September 2022 and December 2022, with follow-up extended until March 2023. The study tracked SARS-CoV-2 infection time (≤14 days, ≤28 days, and ≤10 weeks after embryo transfer), symptoms, vaccination status, the interval between vaccination and embryo transfer, and early pregnancy outcomes, encompassing biochemical pregnancy rate, implantation rate, clinical pregnancy rate, and early miscarriage rate. The study used single-factor analysis and multivariate logistic regression to examine the association between SARS-CoV-2 infection status, along with other relevant factors, and the early pregnancy outcomes. RESULTS: A total of 857 female patients undergoing in vitro fertilization/intracytoplasmic sperm injection treatment were analyzed. In the first stage, SARS-CoV-2 infection within 14 days after embryo transfer did not have a significant negative association with the biochemical pregnancy rate (adjusted odds ratio, 0.74; 95% confidence interval, 0.51-1.09). In the second stage, SARS-CoV-2 infection within 28 days after embryo transfer had no significant association with the implantation rate (36.6% in infected vs 44.0% in uninfected group; P=.181). No statistically significant association was found with the clinical pregnancy rate after adjusting for confounding factors (adjusted odds ratio, 0.69; 95% confidence interval, 0.56-1.09). In the third stage, SARS-CoV-2 infection within 10 weeks after embryo transfer had no significant association with the early miscarriage rate (adjusted odds ratio, 0.77; 95% confidence interval, 0.35-1.71). CONCLUSION: Our study suggests that SARS-CoV-2 infection within 10 weeks after embryo transfer may not be negatively associated with the biochemical pregnancy rate, implantation rate, clinical pregnancy rate, and early miscarriage rate in patients undergoing in vitro fertilization/intracytoplasmic sperm injection treatment. It is important to note that these findings are specific to the target population of in vitro fertilization/intracytoplasmic sperm injection patients aged 20 to 39 years, without previous SARS-CoV-2 infection, and with a body mass index of 18 to 30 kg/m2. This information offers valuable insights, addressing current concerns and providing a clearer understanding of the actual risk associated with SARS-CoV-2 infection after embryo transfer.

COVID-19 nas prisões: validação de um inquérito de conhecimento, atitude e prática / COVID-19 en las cárceles: validación de un estudio de conocimiento, actitud y práctica / COVID-19 in prisons: validity of a knowledge, attitude and practice survey

Resumo Objetivo Validar um inquérito de conhecimento, atitude e prática sobre medidas preventivas da COVID-19 para os funcionários do sistema penitenciário, fundamentado na teoria ambientalista. Métodos Estudo metodológico desenvolvido em quatro etapas: estabelecimento da estrutura conceitual, elaboração do instrumento, validação do conteúdo por juízes e avaliação da aparência pelo público-alvo. O conteúdo de cada item foi validado quanto a objetividade, clareza e relevância. A aparência do inquérito foi avaliada quanto ao objetivo, a organização, ao estilo da escrita e a motivação. Utilizou-se o coeficiente de validação de conteúdo para avaliar a concordância entre os juízes e entre o público-alvo. Os dados foram analisados por meio de distribuições brutas, percentuais, medidas de posição e de dispersão. O índice alfa de Cronbach foi utilizado para analisar a consistência das avaliações dos juízes e do público-alvo. Resultados Quanto ao conteúdo e a aparência, os requisitos avaliados obtiveram concordância superior a 0,9. Na avaliação da consistência, obteve-se índice alfa de Cronbach > 0,9 e > 0,7, quanto ao conteúdo e à aparência, respectivamente, indicando que juízes e público-alvo tenderam a fazer avaliações similares. Conclusão O inquérito apresentou validade de conteúdo e aparência para a coleta de dados referentes a conhecimento, atitude e prática sobre prevenção da COVID-19, para os funcionários do sistema penitenciário, indicando que poderá contribuir para o planejamento e a avaliação de ações de educação em saúde.

Resumen Objetivo Validar un estudio de conocimiento, actitud y práctica sobre medidas preventivas de COVID-19 para los empleados del sistema penitenciario, fundamentado en la teoría ambientalista. Métodos Estudio metodológico llevado a cabo en cuatro etapas: establecimiento de la estructura conceptual, elaboración del instrumento, validación del contenido por jueces y evaluación de la apariencia por el público destinatario. Se validó el contenido de cada ítem respecto a la objetividad, claridad y relevancia. Se evaluó la apariencia del estudio respecto al objetivo, la organización, el estilo de escritura y la motivación. Se utilizó el coeficiente de validez de contenido para evaluar la concordancia entre los jueces y entre el público destinatario. Los datos se analizaron mediante distribuciones brutas, porcentajes, medidas de posición y de dispersión. Se utilizó el índice alfa de Cronbach para analizar la consistencia de las evaluaciones de los jueces y del público destinatario. Resultados Respecto al contenido y a la apariencia, los requisitos evaluados obtuvieron concordancia superior a 0,9. En la evaluación de la consistencia, se obtuvo un índice alfa de Cronbach > 0,9 respecto al contenido y > 0,7 respecto a la apariencia, lo que indica la tendencia de los jueces y del público destinatario a realizar evaluaciones similares. Conclusión El estudio presentó validez de contenido y apariencia para la recopilación de datos referentes a conocimiento, actitud y práctica sobre prevención de COVID-19 para empleados del sistema penitenciario, lo que indica que podrá contribuir a la planificación y evaluación de acciones de educación para la salud.

Abstract Objective To validate a knowledge, attitude and practice survey on preventive measures against COVID-19 for penitentiary system staff based on environmental theory. Methods This is a methodological study developed in four stages: conceptual structure establishment; instrument elaboration; content validity by judges; and appearance assessment by the target audience. The content of each item was validated for objectivity, clarity and relevance. Survey appearance was assessed regarding objective, organization, writing style and motivation. Content validity coefficient was used to assess agreement among judges and the target audience. Data were analyzed using gross distributions, percentages, position and dispersion measures. Cronbach's alpha index was used to analyze the consistency of judges' and target audience's assessments. Results Regarding content and appearance, the assessed requirements achieved agreement greater than 0.9. In consistency assessment, a Cronbach's alpha index > 0.9 and > 0.7 was obtained for content and appearance, respectively, indicating that judges and target audiences tended to make similar assessments. Conclusion The survey presented content and appearance validity for collecting data regarding knowledge, attitude and practice regarding COVID-19 prevention for penitentiary system staff, indicating that it could contribute to health education action planning and assessment.

Perioperative Respiratory-Adverse Events Following General Anesthesia Among Pediatric Patients After COVID-19.

BACKGROUND: The perianesthetic morbidity, mortality risk and anesthesia-associated risk after preoperative coronavirus disease 2019 (COVID-19) omicron variant in pediatric patients have not been fully demonstrated. We examined the association between preoperative COVID-19 omicron diagnosis and the incidence of overall perioperative adverse events in pediatric patients who received general anesthesia. METHODS: This retrospective study included patients aged < 18 years who received general anesthesia between February 1 and June 10, 2022, in a single tertiary pediatric hospital. They were divided into two groups; patients in a COVID-19 group were matched to patients in a non-COVID-19 group during the omicron-predominant period in Korea. Data on patient characteristics, anesthesia records, post-anesthesia records, COVID-19-related history, symptoms, and mortality were collected. The primary outcomes were the overall perioperative adverse events, including perioperative respiratory adverse events (PRAEs), escalation of care, and mortality. RESULTS: In total, 992 patients were included in the data analysis (n = 496, COVID-19; n = 496, non-COVID-19) after matching. The overall incidence of perioperative adverse events was significantly higher in the COVID-19 group than in the non-COVID-19 group (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.89-1.94). The difference was significant for PRAEs (OR, 2.00; 95% CI, 1.96-2.02) but not in escalation of care or mortality. The most pronounced difference between the two groups was observed in instances of high peak inspiratory pressure ≥ 25 cmH2O during the intraoperative period (OR, 11.0; 95% CI, 10.5-11.4). Compared with the non-COVID-19 group, the risk of overall perioperative adverse events was higher in the COVID-19 group diagnosed 0-2 weeks before anesthesia (OR, 6.5; 95% CI, 2.1-20.4) or symptomatic on the anesthesia day (OR, 6.4; 95% CI, 3.30-12.4). CONCLUSION: Pediatric patients with the preoperative COVID-19 omicron variant had increased risk of PRAEs. Patients within 2 weeks after COVID-19 or those with symptoms had a higher risk of PRAEs.

Out-of-hospital cardiac arrest patients during the coronavirus disease 2019 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic had severe impact on the outcome of out-of-hospital cardiac arrest (OHCA) patients and the possibility of bystander cardiopulmonary resuscitation (CPR). Previous studies focused only on the short periods of the pandemic and reported a significant increase in the number of infections. In a retrospective cohort study we aimed to compare the outcomes of OHCA patients 1 year before and 1 year after the onset of COVID-19. Data of 519 OHCA patients during the pre-pandemic (January-December 2019; 262 patients) and intra-pandemic (April 2020-March 2021; 257 patients) periods in Yokohama Municipal Hospital, Japan were collected and analysed retrospectively. The study outcomes were the return of spontaneous circulation (ROSC), admission to hospital, survival to discharge, and cerebral performance category at discharge. The intra-pandemic period was associated with decreased bystander CPR (P = 0.004), prolonged transport time (P < 0.001), delayed first adrenaline administration (P < 0.001), and decrease in ROSC (P = 0.023). Logistic regression analysis revealed that the following factors were significantly associated with ROSC: "pandemic", "shockable initial waveform", and "witness presence".

Outcomes and risk factors of SARS-CoV-2 omicron variant in B-cell lymphoma patients following CD19 targeted CAR-T therapy.

BACKGROUND: Little was known on infection and mortality rates, still less the risk factors of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) omicron variant in B-cell lymphoma patients following CD19 targeted chimeric antigen receptor T cell (CAR-T). AIMS: We performed a retrospective multicenter study and analyzed the details of relapsed/refractory (R/R) B-cell lymphoma patients who received CD19 targeted CAR-T heretofore in five cellular immunotherapy centers in China during the omicron wave. MATERIALS & METHODS: One hundred fifty-four patients were enrolled in this study. RESULTS: Among them, 52 patients (33.8%) were uninfected, 74 patients (48.1) had ambulatory mild disease (including nine patients of asymptomatic infection), 22 patients (14.3%) had moderate disease and six patients (3.9%) had severe disease when data collected up. Three patients with severe disease died from COVID-19, the death rate was 1.9% for all enrolled patients, and 2.9% for infected patients. We also found that patients over 60 years old or with diabetes mellitus (DM) tend to develop severe disease (p = 0.0057 and p = 0.0497, respectively). Patients had CAR-T infusion within 6 months also tend to have severe disease (p = 0.0011). In multivariate logistic regression model, CAR-T infusion within 6 months (relative risk (RR) 40.92; confidence interval (CI) 4.03-415.89; p = 0.002) were associated with significantly higher risk of severe disease. CONCLUSION: Through this study, we conclude that the outcome for B-cell lymphoma patients following CD19 targeted CAR-T therapy when facing omicron infection was improved, but aggressive precautionary measures were particularly crucial for patients with high risk factors.

[Pelvic exenteration for late complications of radiation-induced pelvic injury: a preliminary study].

Objective: To investigate the safety and efficacy of total pelvic exenteration (TPE) for treating late complications of radiation-induced pelvic injury. Methods: This was a descriptive case series study. The inclusion criteria were as follows: (1) confirmed radiation-induced pelvic injury after radiotherapy for pelvic malignancies; (2) late complications of radiation-induced pelvic injury, such as bleeding, perforation, fistula, and obstruction, involving multiple pelvic organs; (3) TPE recommended by a multidisciplinary team; (4) patient in good preoperative condition and considered fit enough to tolerate TPE; and (5) patient extremely willing to undergo the procedure and accept the associated risks. The exclusion criteria were as follows: (1) preoperative or intraoperative diagnosis of tumor recurrence or metastasis; (2) had only undergone diversion or bypass surgery after laparoscopic exploration; and (3) incomplete medical records. Clinical and follow-up data of patients who had undergone TPE for late complications of radiation-induced pelvic injury between March 2020 and September 2022 at the Sixth Affiliated Hospital of Sun Yat-sen University were analyzed. Perioperative recovery, postoperative complications, perioperative deaths, and quality of life 1 year postoperatively were recorded. Results: The study cohort comprised 14 women, nine of whom had recto-vagino-vesical fistulas, two vesicovaginal fistulas, one ileo-vesical fistula and rectal necrosis, one ileo-vesical and rectovaginal fistulas, and one rectal ulcer and bilateral ureteral stenosis. The mean duration of surgery was 592.1±167.6 minutes and the median blood loss 550 (100-6000) mL. Ten patients underwent intestinal reconstruction, and four the Hartmann procedure. Ten patients underwent urinary reconstruction using Bricker's procedure and 7 underwent pelvic floor reconstruction. The mean postoperative hospital stay was 23.6±14.9 days. Seven patients (7/14) had serious postoperative complications (Clavien-Dindo IIIa to IVb), including surgical site infections in eight, abdominopelvic abscesses in five, pulmonary infections in five, intestinal obstruction in four, and urinary leakage in two. Empty pelvis syndrome (EPS) was diagnosed in five patients, none of whom had undergone pelvic floor reconstruction. Five of the seven patients who had not undergone pelvic floor reconstruction developed EPS, compared with none of those who had undergone pelvic floor reconstruction. One patient with EPS underwent reoperation because of a pelvic abscess, pelvic hemorrhage, and intestinal obstruction. There were no perioperative deaths. During 18.9±10.1 months of follow-up, three patients died, two of renal failure, which was a preoperative comorbidity, and one of COVID-19. The remaining patients had gradual and significant relief of symptoms during follow-up. QLQ-C30 assessment of postoperative quality of life showed gradual improvement in all functional domains and general health at 1, 3, and 6 months postoperatively (all P<0.05). Conclusions: TPE is a feasible procedure for treating late complications of radiation-induced pelvic injury combined with complex pelvic fistulas. TPE is effective in alleviating symptoms and improving quality of life. However, the indications for this procedure should be strictly controlled and the surgery carried out only by experienced surgeons.

Bariatric Surgery and COVID-19: a Change of Perspective in a New Phase of the Pandemic.

PURPOSE: The protective role of bariatric surgery (BS) against COVID-19 has been reported by several studies, showing, in the first pandemic waves, better outcome of the infection in patients that had undergone BS. With the virus progressive endemicity, BS benefits on COVID-19 clinical course could appear less evident, while COVID-19 effects on BS outcomes must be investigated. In this national multicentric cross-sectional study, we compared COVID-19 incidence and clinical course between a cohort of patients that had undergone BS (OP) and a cohort of candidates to BS (WS); moreover, we analyzed BS outcomes based on SARS-CoV-2 positivity/negativity. METHODS: From June to December 2021, 522 patients from five Italian referral centers were administered an 87-item telephonic questionnaire completing the analysis of electronic medical records. Demographics, COVID-19 "tested" incidence, suggestive symptoms and clinical outcome parameters of OP and WS were compared. BS outcomes parameters were compared between OP that developed the disease or not. RESULTS: COVID-19 incidence was the same in OP and WS, while symptoms and clinical course seemed milder in OP, with no data individually reaching statistical significance. OP who developed SARS-CoV-2 infection had higher excess weight loss than negative OP (66.8% ± 22.1 vs. 57.7% ± 22.8, p = 0.029). Positive OP had had gastric-bypass (RYGB/OAGB) more frequently than negative ones (38.4% vs. 18.2%, p = 0.025). CONCLUSION: With the disease becoming endemic, BS protective role against COVID-19 seems clinically less relevant. BS outcomes can be affected by COVID-19, thus imposing careful follow-up for positive patients, especially if undergoing gastric-bypass.