Reference set for performance testing of pediatric vaccine safety signal detection methods and systems

BackgroundSafety signal detection in spontaneous reporting system databases and electronic healthcare records is key to detection of previously unknown adverse events following immunization. Various statistical methods for signal detection in these different datasources have been developed, however none are geared to the pediatric population and none specifically to vaccines. A reference set comprising pediatric vaccine-adverse event pairs is required for reliable performance testing of statistical methods within and across data sources.MethodsThe study was conducted within the context of the Global Research in Paediatrics (GRiP) project, as part of the seventh framework programme (FP7) of the European Commission. Criteria for the selection of vaccines considered in the reference set were routine and global use in the pediatric population. Adverse events were primarily selected based on importance. Outcome based systematic literature searches were performed for all identified vaccine-adverse event pairs and complemented by expert committee reports, evidence based decision support systems (e.g. Micromedex), and summaries of product characteristics. Classification into positive (PC) and negative control (NC) pairs was performed by two independent reviewers according to a pre-defined algorithm and discussed for consensus in case of disagreement.ResultsWe selected 13 vaccines and 14 adverse events to be included in the reference set. From a total of 182 vaccine-adverse event pairs, we classified 18 as PC, 113 as NC and 51 as unclassifiable. Most classifications (91) were based on literature review, 45 were based on expert committee reports, and for 46 vaccine-adverse event pairs, an underlying pathomechanism was not plausible classifying the association as NC.ConclusionA reference set of vaccine-adverse event pairs was developed. We propose its use for comparing signal detection methods and systems in the pediatric population.     

脑出血围手术期护理安全中细节管理的重要性分析

目的分析脑出血围手术期护理安全中细节管理的重要性。方法将于2018年6-10月在该院接受治疗的60例脑出血围术期患者作为该研究的常规组。将于2018年11月-2019年3月在该院接受治疗的60例脑出血围术期患者作为该研究的细节组。该院于2018年11月开始实施细节管理,以加强保障脑出血围术期患者的安全。对比两组患者的护理满意度、手术失败率、死亡率、住院时间及日常生活能力。结果细节组护理满意度明显高于常规组(P<0.05)。常规组的手术失败率、死亡率为均高于细节组,差异无统计学意义(P>0.05);细节组的住院时间明显短于常规组(P<0.05),ADL评分明显大于常规组(P<0.05)。结论细节管理在脑出血围手术期护理安全中具有相当重要性,可提升护理满意度,加快恢复速度,提升恢复效果。     

Leadership Development in UK Medical Training: Pedagogical Theory and Practice

Phenomenon: The central role of clinical leadership in achieving the vision of quality and productivity could be attained by investing in its development in postgraduate medical education. Approach: A critical review of selected literature is presented. Findings: The author identifies some of the main theoretical constructs related to leadership; the pedagogical underpinning of medical leadership programs; their learning objectives; and the mixture of methods, individual and collective, to achieve them. Insights: How to best develop leadership through medical education remains an open debate. Experiential learning, reflective practice, action learning, and mentoring could provide the foundations of leadership development. Application of the aforementioned should be cautious due to limitations of the concept of leadership as currently promoted and lack of robust evaluation methodologies.     

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

ObjectivesThe aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.BackgroundThe National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of “real-world” patients have not been previously reported.MethodsPatients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.ResultsThe study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA₂DS₂-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier–estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.ConclusionsThis study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.     

Use of different combination diphtheria-tetanus-acellular pertussis vaccines does not increase risk of 30-day infant mortality. A population-based linkage cohort study using administrative data from the Australian Childhood Immunisation Register and the National Death Index.

Objective

To determine whether differences in combination DTaP vaccine types at 2, 4 and 6?months of age were associated with mortality (all-cause or non-specific), within 30?days of vaccination.

刍议研究生科学道德和学风教育质量管理体系之构建

研究生科学道德和学风建设是学位与研究生教育的重要组成部分。针对近年来科学研究和学术活动中各种违背科学道德和学术规范的行为时有发生,国家教育部对研究生科学道德和学风建设日益重视,因此构建研究生的科学道德和学风教育质量管理体系具有十分重要的意义。实现研究生科学道德和学风教育质量体系的方针和目标需具备三个要素,即教育实践的模式(集主题教育、方法学习、学术实践三位一体)、有效性评价机制和绩效考核机制。此外,尚需建立体系优化机制,以适应各种内外部因素的变化,保持体系的更新和优化。     

加强医疗仪器设备管理提高医疗仪器设备使用效益

加强医疗设备管理,提高设备使用效益,制定合理的计划,正确选购设备,为医院提供品种、性能、精度适当的技术装备。