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Objectives: Using a historical control or external control arm (ECA) to augment or replace a concurrent control arm in a randomized trial is a hot topic given the challenge of patient recruitment in rare diseases or during COVID-19 pandemic. The FDA released draft guidance in 2021 on effectiveness and safety submissions using real-world evidence. While the guidance focuses mainly on elements of study design and data source selection, there is a lack of consensus in the selection of appropriate statistical methods when constructing an ECA. This study discusses rigorous statistical methodology for ECA-supported trials in regulatory or HTA submissions. Method(s): Targeted literature reviews of statistical simulations comparing methods for ECA in statistical journals were performed. The articles compared commonly used ECA-construction and analysis methods were selected and summarized, including but not limited to propensity score (PS)-based matching, weighting, and stratification, and PS plus Bayesian integrated approaches. Result(s): Type I error, power, bias, and coverage probability are common criteria used to compare different methods. When imbalances only exist in known baseline covariates and the outcome distributions are the same between the trial concurrent control and ECA, the PS method alone or paired with commensurate prior yield almost unbiased estimates, good Type I errors, and coverage probability. PS plus Bayesian approaches have wider interval width and lower power compared with PS-only methods. When there is a change in the outcome distribution over time, the PS (matching or IPTW) and commensurate prior integrated methods yield the smallest biases among all methods. Conclusion(s): PS and Bayesian integrated methods outperformed the PS-only methods in terms of bias and Type I error when outcome distribution changed with current trial control. A "sweet spot" that balances all criteria through trial-specific simulations could provide the ideal setting of trial analyses plan based on specific trial design and scenarios.Copyright © 2023
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Objective: To examine COVID-19 vaccine uptake and its determinants among teenagers and their parents in Zhejiang, China. Method(s): An online cross-sectional study was conducted among parents of teenagers in Zhejiang, China from May 1 to 31, 2022. Data were interpreted via univariate and multivariate analyses using the statistical package for the social sciences (SPSS) program. Result(s): A total of 11115 (96.11%) participants and 11449 (99.00%) of their children in Zhejiang, China had been vaccinated against COVID-19. Children whose parents did not receive COVID-19 vaccination were 19 times (aOR 18.96, 95%CI 12.36-29.08) more likely to be unvaccinated than their counterparts. In addition, children with no previous influenza vaccination, those whose parents doubted the COVID-19 vaccine's safety or effectiveness, were 6.11 times (aOR 6.11, 95%CI 2.80-13.34), 8.27 times (aOR 8.27, 95%CI 5.33-12.83), and 2.69 times (aOR 2.69, 95%CI 1.11-6.50) more likely to be unvaccinated than their counterparts, respectively. COVID-19 vaccine uptake varied between different sociodemographic groups. However, the odds of receiving the COVID-19 vaccine decreased as age and education level increased. The main refusal reasons claimed by participants were that they had medical conditions that may not qualify them for vaccination (53.78%), followed by safety concerns about the vaccine (13.56%), not knowing where to get vaccinated (6.44%), and concerns about fertility issues (5.56%). Conclusion(s): Despite a highly encouraging level of COVID-19 vaccine uptake in Zhejiang, China, the elderly and highly educated people had lower COVID-19 vaccine uptake. It is suggested that tailored health education strategies should be taken to increase the COVID-19 vaccine uptake in such groups. Furthermore, with vaccination rates at such a high level, the pandemic is still ongoing, and public confidence in vaccines may decline. Thus, sufficient evidence-based information regarding COVID-19 vaccines should be provided to the public. Copyright © 2023 Asian Pacific Journal of Tropical Medicine.
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Objective: To examine COVID-19 vaccine uptake and its determinants among teenagers and their parents in Zhejiang, China. Methods: An online cross-sectional study was conducted among parents of teenagers in Zhejiang, China from May 1 to 31, 2022. Data were interpreted via univariate and multivariate analyses using the statistical package for the social sciences (SPSS) program. Results: A total of 11115 (96.11%) participants and 11449 (99.00%) of their children in Zhejiang, China had been vaccinated against COVID-19. Children whose parents did not receive COVID-19 vaccination were 19 times (aOR 18.96, 95%CI 12.36-29.08) more likely to be unvaccinated than their counterparts. In addition, children with no previous influenza vaccination, those whose parents doubted the COVID-19 vaccine's safety or effectiveness, were 6.11 times (aOR 6.11, 95%CI 2.80-13.34), 8.27 times (aOR 8.27, 95%CI 5.33-12.83), and 2.69 times (aOR 2.69, 95%CI 1.11-6.50) more likely to be unvaccinated than their counterparts, respectively. COVID-19 vaccine uptake varied between different sociodemographic groups. However, the odds of receiving the COVID-19 vaccine decreased as age and education level increased. The main refusal reasons claimed by participants were that they had medical conditions that may not qualify them for vaccination (53.78%), followed by safety concerns about the vaccine (13.56%), not knowing where to get vaccinated (6.44%), and concerns about fertility issues (5.56%). Conclusions: Despite a highly encouraging level of COVID-19 vaccine uptake in Zhejiang, China, the elderly and highly educated people had lower COVID-19 vaccine uptake. It is suggested that tailored health education strategies should be taken to increase the COVID-19 vaccine uptake in such groups. Furthermore, with vaccination rates at such a high level, the pandemic is still ongoing, and public confidence in vaccines may decline. Thus, sufficient evidence-based information regarding COVID-19 vaccines should be provided to the public.
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The COVID-19 pandemic may have been a difficult time to join a new organization. Drawing on the feelings-as-information theory, this study explores how COVID-19 lockdown anxiety influenced newcomers' job satisfaction during their first few months of work. We tested 357 new employees working in 84 cities across China. We conducted a longitudinal study, and participants were invited to complete the same survey at two time points. Cross-lagged panel analysis was conducted to test our hypotheses. We confirmed that COVID-19 lockdown anxiety at Time 1 predicted less job satisfaction at Time 2, whereas the data did not support the idea of reverse causality. These findings suggest public health crises like the pandemic can impact newcomers' job satisfaction, especially during China's Zero-Covid Policy.
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COVID-19 highlights the lack of interdisciplinary medical talents. The international history of medical education shows the urgent need of high-level interdisciplinary medical talents. Anchoring the goal to develop a global center of talents and highland of innovation, this article takes medical education of Zhejiang University as an example, focusing on and exploring the training mode of high-level interdisciplinary medical talents in the new era. It includes: Firstly, optimizing the training mode of eight-year program for medical doctors with non-medical bachelor degree followed with complete education for a medical doctorate that innovates the curriculum system of clinical medicine;secondly, creating the training system of postdoctor of clinical medicine and integrating medical resources that include high-quality talents and health care system, in order to build a high-quality teaching staff with a interdisciplinarity background and innovative bases. It not only strengthens the residents' competency and frontier creativity, but also ensures the sustainable development of interdisciplinary medical talents. The reform of training mode, curriculum system, teaching staff and clinical teaching bases all contribute to the goal of building a country with interdisciplinary talents that serve the frontier of science and technology in the world, the major needs of the country and people's health in the new era.Copyright © 2022, Peking Union Medical College Hospital. All rights reserved.
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Background: Remdesivir (RDV) is a broad-spectrum nucleotide analog antiviral approved for the treatment of COVID-19 in patients who are hospitalized or non-hospitalized and at risk of progressing to severe disease. Here we present SARS-CoV-2 resistance analyses from the Phase 3 PINETREE trial. Method(s): PINETREE was a double-blind, placebo-controlled trial of nonhospitalized participants (N=562) with COVID-19 and >=1 risk factor for disease progression, randomized to receive RDV or placebo once-daily for 3 days. The whole genome of SARS-CoV-2 was sequenced from nasopharyngeal swabs collected at days 1 (baseline), 2, 3, 7, and 14 using next-generation sequencing. Emergent amino acid substitutions in SARS-CoV-2 from participants treated with RDV were tested in a replicon system to determine if they alter sensitivity to RDV. Result(s): Resistance analysis criteria included all participants in the RDV group and 50% in the placebo group with viral load above the lower limit of detection for the viral load assay. Of 281 participants who met these criteria, baseline and postbaseline sequencing data were available for 115/130 (88.5%) participants in the RDV group and 129/151 (85.4%) participants in the placebo group (Table 1). Among these, emergent substitutions in Nsp12 were observed in 8/115 (7.0%) in the RDV group and 7/129 (5.4%) in the placebo group. A total of 7 emergent amino acid substitutions in Nsp12 were observed in the RDV group, but not in the placebo group. Among these, only one substitution from one participant (A376V;first detected at day 14), showed reduced in vitro susceptibility to RDV, with a half-maximal effective concentration (EC50) fold-change of 12.6 compared with a wildtype reference. The participant achieved clinical recovery by day 14. None of the other substitutions impacted RDV susceptibility (EC50 fold-change <=1.4). Emergent substitutions in Nsp8, Nsp10, Nsp13, or Nsp14 were detected in 10/115 (8.7%) of participants in the RDV group and 10/129 (7.8%) in the placebo group, with substitutions in the RDV group showing similar susceptibility to RDV as the wildtype reference (EC50 fold-change <=2.3). Conclusion(s): Overall, emergent substitutions in the SARS-CoV-2 replication complex including Nsp12 were observed with similar frequency in the RDV and placebo groups, with only one participant developing a substitution associated with reduced in vitro RDV susceptibility, indicating a high barrier to the development of RDV resistance in COVID-19 patients.
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Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current global pandemic of the COVID-19, which has persisted partly through the emergence of new variants. A non-infectious, convenient, and reproducible in vitro system is needed to assess drug susceptibility of new variants of concern and potential drug resistance mutations. Method(s): The SARS-CoV-2 replicon protocol was adapted and optimized based on {Zhang 2021}. The replicon RNA was produced by in vitro transcription of full-length replicon DNA assembled by ligation of plasmid fragments encoding for the SARS-CoV-2 non-structural proteins (Nsps), nucleoprotein and gaussia luciferase reporter protein. Wild-type and mutant replicon RNAs were transfected into Huh7-1CN cells by electroporation and treated with remdesivir (RDV). To determine EC50 values, luciferase activity was determined at 48 hours post transfection. A recombinant SARS-CoV-2 virus rescue system {Xie 2020} was used to generate matching Nsp mutants for comparison with the replicon system. Result(s): The selected substitutions reflective of Omicron BA.5 sub-lineage BF.7 variant: the triple mutants (Nsp12 (P323L) +Nsp13 (R392C) + Nsp14 (I42V), and a single Nsp12 L247F mutant as well as several specific Nsp12 mutations identified by in vitro resistance selection with RDV or RDV parent nucleoside analog GS-441524 were cloned into the replicon and tested for susceptibility to RDV. RDV inhibited the SARS-CoV-2 wild-type replicon with a mean EC50 value of 14.7 +/- 3.5 nM (N=9). The Nsp12 P323L substitution, a common polymorphism in all major variants of concern including Omicron, was fully susceptible to RDV with a 0.6-fold change in EC50 from the wild-type. The Omicron BF.7 triple mutants and L247F were also fully susceptible to RDV with 0.5- and 0.4-fold changes, respectively. Nsp12 substitutions F480L, V557L, V792I, S759A+V792I, and C799F resulting from in vitro resistance selections with RDV showed minimal to moderate levels of reduced susceptibility to RDV (1.8 to 18.3-fold change) (Table 1). The RDV EC50 fold changes correlated between the noninfectious replicon and recombinant infection virus system (Table 1). Conclusion(s): The replicon system is a convenient and reproducible model to test the susceptibility of SARS-CoV-2 mutant variants to RDV and potentially other antivirals. The common Nsp12 polymorphisms in all variants including the highly transmissible Omicron variant were fully susceptible to RDV.
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Tourism is linked to multiple dimensions, such as the economy, society, and environment, and the relationships among its influencing factors are complex, diverse, and overlapping. This study constructed an evaluation index system to measure the degree of coordinated development of tourism, transportation, and the regional economy, then built a tourism-transportation-based Spatial Durbin Model (SDM) regarding the process of the coordinated development of tourism in the Beijing-Tianjin-Hebei region (BTHR) from 2010 to 2020. This paper explains the current status of sustainable tourism development in the BTHR and the impact and spillover effects of transportation on tourism development. The results show that the normalized tourism coordinated development index (NTCDI) of the BTHR increased from 13.61 in 2010 to 18.75 in 2019, then decreased to 14.45 in 2020. The results of SDM show that different transportation modes have different spillover effects on tourism. Specifically, civil aviation transportation has a positive impact and significant spillover on a city's tourism revenue (TR), while high-speed railway transportation has a negative spillover effect. The model results also show that the degree of openness of the city and city economic development level have significant positive effects and spillover effects on tourism development. Finally, the implications of related variables are discussed, and some suggestions are put forward on tourism development in the BTHR. However, there are some limitations in this study. In the future, international cooperation and data sharing will be strengthened, and multivariate methods such as social network analysis, artificial intelligence, and machine learning will be further integrated to achieve accurate simulation and prediction of the spatial spillover effects of tourism transportation.
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COVID-19 opened a window of opportunity to change the green development of the hospitality industry. For many years, Chinese tourists have been the world's largest source of outbound tourists. Therefore, this study attempted to improve built-environment strategies for green rooms at B&Bs using the empirical statistics of Chinese tourists after the end of COVID-19 control measures and different green B&B standards, combining IPA (importance-performance analysis). For the lack of a green built-environment study from a tourism perspective, this study can be used mainly for improving the green satisfaction of urban B&Bs as it attempted to fill the gaps in research on green B&B rooms. This study will significantly help improve the quality of green rooms for the B&B industry in the future, and it also provides an improved green B&B room sample for other countries and regions. Moreover, it is an optimistic attempt at hospitality and tourism recovery. © 2023 by the authors.
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In recent years, the corona virus disease 2019 (COVID-19) pandemic has had a huge impact on the global medical, political and economic fields. Since the beginning of the COVID-19 epidemic, our understanding of the impact of COVID-19 has grown exponentially. Recently, the COVID-19 epidemic has changed rapidly in China, and there has been controversy over how to carry out surgical operations for patients with lung neoplastic lesions. Some studies have shown that lung cancer patients undergoing surgery are more likely to experience respiratory failure and perioperative death after contract-ing COVID-19 than the general population, however, delays in cancer treatment are also associated with increased mortality among these patients. In particular, the novel coronavirus Omikron variant has a higher transmissibility and may escape the immunity obtained through the previous novel coronavirus infection and vaccination. In order to minimize the risk of novel coronavirus infection in surgical patients, it is necessary to develop new treatment guidelines, expert consensus and preventive measures. However, the current rapid change of the epidemic situation has led to insufficient time and evidence to develop guidelines and consensus. Therefore, thoracic surgeons need to evaluate specific patient populations at higher risk of severe complications before surgery and weigh the benefit of surgical treatment against the risk of novel coronavirus infection. We try to give some recommendations on lung surgery during the current domestic epidemic situation based on the guidelines and consensus of oncology and thoracic surgery organizations in different regions on lung surgery.Copyright © 2023, Chinese Journal of Lung Cancer. All rights reserved.
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In order to improve risk prevention and control capabilities for international sports events under the background of COVID-19, case data of 23 international sports since the pandemic outbreak were collected, and an evolutionary network model with COVID-19 as risk source was established. Then, risk analysis on the model was carried out based on in-and-out degree, number of sub-net nodes, the shortest path and average path of complex network theory, key risk event nodes were identified, and preventive measures were put forward. Finally, critical chains were obtained by analyzing causal mechanism and types of risk chains, and countermeasures and suggestions for chain disconnection and disaster mitigation were put forward. The results show that severe epidemic situation and rising risk of virus transmission in host cities are the key nodes in evolutionary network, and cycle chain of political relations and public opinion is the most destructive one. Therefore, it is necessary to promote the development of a public opinion monitoring system and strengthen positive publicity of sports events. © 2020 China Safety Science Journal. All rights reserved.
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This paper analyses the precarity of tourism in viral pandemic times through an analysis of animal-human relations in China's panda and valley tourism at Dajiuzhai. Drawing on a tour to Dajiuzhai to see giant pandas and the valleys of Jiuzhai, which was disrupted midway by increased viral infections, we trace ethnographically how disruptions in tourism emerge in the micro-setting of a single viral-hit tour and highlight the roles of natural agents, pandas, valleys and virus play, alongside humans in tourism's fluid assemblages. Desire/wish to encounter pandas motivated the formation of a fluid constellation of tourism objects, species and humans, which was aligned towards the goal of a stable tourism experience but persistently disturbed. Animal-human relation-based tourism assemblage at Dajiuzhai was found to be a fluid spatiality that coped with Covid-19 disruptions through responses at attractions involving health checks and declarations but remained precarious despite its transformational potentialities. © The Author(s) 2023.
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The COVID-19 pandemic has made virtual work more prevalent than ever. Building on the theoretical frameworks of network inertia and media affordances, this paper examines how network characteristics (tie strengths and heterogeneity), and media affordances (persistence and social presence) jointly influence virtual workers' intention to communicate with colleagues. Data from a U.S. nationally representative sample (N = 389) provided partial support for both theories. Tie strength and social presence had a significant impact on virtual workers' communication intention. Psychological heterogeneity influenced people's intention to approach colleagues, but demographic heterogeneity did not. Theoretical and practical contributions were discussed. © 2023 Western Social Science Association.
ABSTRACT
In recent years, the corona virus disease 2019 (COVID-19) pandemic has had a huge impact on the global medical, political and economic fields. Since the beginning of the COVID-19 epidemic, our understanding of the impact of COVID-19 has grown exponentially. Recently, the COVID-19 epidemic has changed rapidly in China, and there has been controversy over how to carry out surgical operations for patients with lung neoplastic lesions. Some studies have shown that lung cancer patients undergoing surgery are more likely to experience respiratory failure and perioperative death after contract-ing COVID-19 than the general population, however, delays in cancer treatment are also associated with increased mortality among these patients. In particular, the novel coronavirus Omikron variant has a higher transmissibility and may escape the immunity obtained through the previous novel coronavirus infection and vaccination. In order to minimize the risk of novel coronavirus infection in surgical patients, it is necessary to develop new treatment guidelines, expert consensus and preventive measures. However, the current rapid change of the epidemic situation has led to insufficient time and evidence to develop guidelines and consensus. Therefore, thoracic surgeons need to evaluate specific patient populations at higher risk of severe complications before surgery and weigh the benefit of surgical treatment against the risk of novel coronavirus infection. We try to give some recommendations on lung surgery during the current domestic epidemic situation based on the guidelines and consensus of oncology and thoracic surgery organizations in different regions on lung surgery.Copyright © 2023, Chinese Journal of Lung Cancer. All rights reserved.
ABSTRACT
In order to improve risk prevention and control capabilities for international sports events under the background of COVID-19, case data of 23 international sports since the pandemic outbreak were collected, and an evolutionary network model with COVID-19 as risk source was established. Then, risk analysis on the model was carried out based on in-and-out degree, number of sub-net nodes, the shortest path and average path of complex network theory, key risk event nodes were identified, and preventive measures were put forward. Finally, critical chains were obtained by analyzing causal mechanism and types of risk chains, and countermeasures and suggestions for chain disconnection and disaster mitigation were put forward. The results show that severe epidemic situation and rising risk of virus transmission in host cities are the key nodes in evolutionary network, and cycle chain of political relations and public opinion is the most destructive one. Therefore, it is necessary to promote the development of a public opinion monitoring system and strengthen positive publicity of sports events. © 2020 China Safety Science Journal. All rights reserved.
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The emergence of viral variants has driven a continuous pandemic with a higher possibility of airborne transmission and a larger scale of infective cases, posing greater demands on indoor risk control. However, the role of room-level air recirculation systems (RRSs) in infection control remains unclear due to insufficient detailed research. There are also fewer analyses of the filtering rating of recirculation filters from the perspective of multi-scale particle size. Thus, a simulation procedure to assess the performance of RRSs on infection control that accounts the transient recirculation of real virus-laden particles in multi-scale sizes was proposed, and focusing on recirculation filter strategies to balance the risk limitation and energy cost. A poorly ventilated winter classroom was selected as a typical environment equipped with RRSs to operate this procedure. Different RRS strategies (i.e., wall-mounted air conditioners (WMAC), floor-standing air conditioners (FSAC) and 4-way cassette air conditioners (WCAC)) were compared. The results show the important contribution of recirculated particles to accumulating the overall infection risk of susceptible occupants towards a high basic reproduction number (Ro > 1). Then, there is a strong correlation of the spatial distributions between high-risk zones and large vortexes at the breathing height of susceptible occupants. Considering rating suitability and filtration effectiveness, the optimization of recirculation filters on energy and cost can be suggested with comparable benefits of infection control. © 2023 Elsevier B.V.