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1.
Recent guidance on safety monitoring during drug development, issued by regulatory authorities in the United States and European Union, indicate a shift in focus towards aggregate safety monitoring and scientific evaluation of integrated safety data. The call for program‐level reviews of accumulating safety data, including from ongoing studies, provides an opportunity to leverage the scientific expertise and medical judgment of safety management teams with (a) a multidisciplinary approach, (b) quantitative frameworks to measure level of evidence, and (c) assessments that are product‐specific and driven by medical judgment. A multidisciplinary team, regularly reviewing aggregate safety data throughout the development program, is vital not only for early signal detection but also for generating a better understanding of the accumulating data and context needed for decreasing false alarms. 相似文献
2.
在倡导"生命至上、安全第一"的新时代,安全素质已然成为教师专业素质结构中的重要组成部分。但目前我国中小学教师安全素质水平较低,其主要原因在于校内安全教育的低效与共性化、职后安全培训的不足以及自主学习途径的缺乏。针对当前存在的主要问题,教师安全素质培养路径的优化和培养体系的构建可以从三个方面展开:首先,在职前修订师范教育人才培养标准,重建教师专业素质结构,同时调整安全教育的课程设置,协同第二课堂提升教师安全素质;其次,在职后扩大教师安全培训对象,建立"分层进阶"新模式,对安全考试合格者发放教师安全培训合格证书,调整和完善中小学校岗位安全工作指南;第三,在日常工作期间,逐步改善教师自主学习条件,积极开展安全专题类校本课程研究。 相似文献
3.
Brianna Keogh Poorna Kushalnagar Alina Engelman 《Journal of American college health : J of ACH》2020,68(1):1-5
AbstractObjective: The purpose of the study was to investigate whether peer support and demographic characteristics predicted food security among deaf college students. Participants: The sample included 166 deaf college students at Gallaudet University. Methods: Participants completed a bilingual online survey in American Sign Language (ASL) and English. This survey included USDA’s 6-item food security survey, questions about peer support and socio-demographic characteristics. Results: Out of 166 students (mean age =23; SD?=?6), 60.7% were food secure. About 26.4% were at-risk for low food security and another 12.9% had very low food security. The sample included respondents who identified as people of color (54%) and women (52%). Binary logistic regression revealed that compared to people who reported always receiving peer support, people who never received peer support were 16.3 times more likely to experience food insecurity (adj OR: 16.325, 95% CI 1.824–146.107). Conclusions: This study demonstrates a strong relationship between peer support and deaf college students' food security experiences. 相似文献
4.
Iñaki HERAS-SAIZARBITORIA Olivier BOIRAL Ander IBARLOZA 《International labour review / International Labour Office》2020,159(3):397-421
This article analyses the genesis of the ISO 45001 standard on occupational health and safety, a new initiative of transnational private regulation. The authors draw a picture of controversy from interviews with stakeholders involved in its design, approval and initial dissemination, and from a qualitative content analysis of the internal documentation of the committee responsible for its approval. Like its predecessors relating to environmental management – ISO 14001 – and corporate social responsibility – ISO 26000 – this new standard raises serious concerns among stakeholders given that it deals with substantive political, social and legal issues. 相似文献
5.
AbstractNudge theory describes how indirect suggestions and positive reinforcement can influence decision-making. We used nudge theory to implement a traffic-light labeling and choice architecture (modifying product placement) intervention at Harvard University cafeterias, but found no significant change in sales. Survey and focus group data showed that some students thought the labeling may exacerbate eating disorders, however, there is extremely limited research on potential negative consequences of labeling. One way to describe these findings is through 20th century philosopher Michel Foucault’s concept of biopower. Biopower manipulates cultural norms and nudges individuals to engage in self-surveillance and self-discipline, de facto subjugating themselves to certain ways of being. Biopower may lead to the creation of an in-group and an out-group based on who can adopt the new behaviors, such as healthy eating. Those in the out-group may face additional unintended consequences, highlighting the need for mixed-methods research to better evaluate public health interventions. 相似文献
6.
7.
This article presents a discourse on the incorporation of organizational factors into probabilistic risk assessment (PRA)/probabilistic safety assessment (PSA), a topic of debate since the 1980s that has spurred discussions among industry, regulatory agencies, and the research community. The main contributions of this article include (1) identifying the four key open questions associated with this topic; (2) framing ongoing debates by considering differing perspectives around each question; (3) offering a categorical review of existing studies on this topic to justify the selection of each question and to analyze the challenges related to each perspective; and (4) highlighting the directions of research required to reach a final resolution for each question. The four key questions are: (I) How significant is the contribution of organizational factors to accidents and incidents? (II) How critical, with respect to improving risk assessment, is the explicit incorporation of organizational factors into PRA? (III) What theoretical bases are needed for explicit incorporation of organizational factors into PRA? (IV) What methodological bases are needed for the explicit incorporation of organizational factors into PRA? Questions I and II mainly analyze PRA literature from the nuclear domain. For Questions III and IV, a broader review and categorization is conducted of those existing cross-disciplinary studies that have evaluated the effects of organizational factors on safety (not solely PRA-based) to shed more light on future research needs. 相似文献
8.
Alberto Garre Geraldine Boué Pablo S. Fernández Jeanne-Marie Membré Jose A. Egea 《Risk analysis》2020,40(2):336-351
Decision making in food safety is a complex process that involves several criteria of different nature like the expected reduction in the number of illnesses, the potential economic or health-related cost, or even the environmental impact of a given policy or intervention. Several multicriteria decision analysis (MCDA) algorithms are currently used, mostly individually, in food safety to rank different options in a multifactorial environment. However, the selection of the MCDA algorithm is a decision problem on its own because different methods calculate different rankings. The aim of this study was to compare the impact of different uncertainty sources on the rankings of MCDA problems in the context of food safety. For that purpose, a previously published data set on emerging zoonoses in the Netherlands was used to compare different MCDA algorithms: MMOORA, TOPSIS, VIKOR, WASPAS, and ELECTRE III. The rankings were calculated with and without considering uncertainty (using fuzzy sets), to assess the importance of this factor. The rankings obtained differed between algorithms, emphasizing that the selection of the MCDA method had a relevant impact in the rankings. Furthermore, considering uncertainty in the ranking had a high influence on the results. Both factors were more relevant than the weights associated with each criterion in this case study. A hierarchical clustering method was suggested to aggregate results obtained by the different algorithms. This complementary step seems to be a promising way to decrease extreme difference among algorithms and could provide a strong added value in the decision-making process. 相似文献
9.
The widely used empirical Bayes (EB) and full Bayes (FB) methods for before–after safety assessment are sometimes limited because of the extensive data needs from additional reference sites. To address this issue, this study proposes a novel before–after safety evaluation methodology based on survival analysis and longitudinal data as an alternative to the EB/FB method. A Bayesian survival analysis (SARE) model with a random effect term to address the unobserved heterogeneity across sites is developed. The proposed survival analysis method is validated through a simulation study before its application. Subsequently, the SARE model is developed in a case study to evaluate the safety effectiveness of a recent red‐light‐running photo enforcement program in New Jersey. As demonstrated in the simulation and the case study, the survival analysis can provide valid estimates using only data from treated sites, and thus its results will not be affected by the selection of defective or insufficient reference sites. In addition, the proposed approach can take into account the censored data generated due to the transition from the before period to the after period, which has not been previously explored in the literature. Using individual crashes as units of analysis, survival analysis can incorporate longitudinal covariates such as the traffic volume and weather variation, and thus can explicitly account for the potential temporal heterogeneity. 相似文献
10.
ABSTRACT The shift in the technology landscape has altered the technology ecosystem of adolescents and emerging adults in the 21st century. Yet, with greater use of digital gadgets comes greater mental health risks that technological advancement brings. This study provides a narrative review of contemporary cyber risks faced by adolescents and emerging adults. In particular, this review will cover dangers and effects of cyber-bullying, social media, cyber-dating violence, sextortion, sexting, revenge porn, online dating, catfishing, and scammers, with an emphasis to raise awareness and encourage proactive efforts dedicated to address these social concerns as the digital era continues to evolve. 相似文献