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.     

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.

Measuring behaviour: The tools and the strategies

Animal behaviour can be viewed as a stream of elements, which, once accurately described, can be counted and timed. Data acquisition techniques and tools are reviewed, and some strategies for collection and analysis of data using PC computers are suggested. Automated instruments are not satisfactory for the study of complex behaviour and as such systemic observation remains irreplaceable. IBM PC-type computers, with a wide range of analytical software (e.g., spreadsheets, statistical packages, technical graphics), are practical for data acquisition. Several systems which can satisfy different applications are reviewed. Some systems can communicate with a videorecorder, a facility which remarkably increases the accuracy of measurement; this is essential for meaningful analyses of the internal structure of behavioural streams (sequences, time patterns) or communication processes. The power of new tools enables behavioural measurement with the necessary complexity to allow a whole new set of questions to be addressed. However, it also increases demands for meaningful content and analysis of data.     

结合计算法和单一酶免法测定血清游离睾酮结果比较

目的　探寻测定血清游离睾酮 (FT)浓度的准确方法。　方法　 12 9例 45岁以上健康男性 ,按年龄分为 4组 ,收集血清标本 -40℃冻存。酶标免疫方法同批测定FT ,同时测定总睾酮 (T)和性激素结合球蛋白 (SHBG)并代入Vermeulen公式计算 :FT =T -2 3 .43FTSHBG -(T -2 3 .43FT) × 10 - 9mol/L。对两种方法测定结果进行统计学比较。　结果　 12 9例标本中酶免法FT为 (46.69± 2 1.79)pmol/L ,计算法为 (3 96.3 0± 3 17.0 4)pmol/L ,t =13 .0 1,P <0 .0 1,差异有非常显著性意义。两种方法测定FT浓度各年龄组间差异均有非常显著性意义 (P <0 .0 1) ;与年龄相关分析差异均有非常显著性意义 (P <0 .0 1) ,相关程度计算法大于酶免法。FT/T平均百分数酶免法为 0 .2 3 % ,计算法为 1.42 %。　结论　结合计算法检测FT浓度较酶免法更科学、正确 ,更适用于老年男子部分性雄激素缺乏综合征 (PADAM )的诊断     

同位素扫描图象的数据传输：BCM—80—APPLEⅡ

本文介绍了1种由BCM-80单板机到AppleⅡ微机的图象数据传输方法。这种方法以盒式磁带作为传输工具,并采用AppleⅡ的磁带记录格式将由BCM-80所采集的同位素扫描图象数据传送到AppleⅡ微机之中,进行分析处理,然后输出1幅静止的易于识别和诊断的图象。此种方法不需要增加任何硬件,具有简单、可靠、传输速度快等优点。     

结直肠肿瘤多学科协作诊治模式的数据体系构建与运作策略

目的阐述在结直肠肿瘤多学科协作（MDT）诊治模式下,如何构建数据体系及其运作策略。方法阐明构建数据体系的原因,结合实践描述结直肠肿瘤数据体系的基本构成及如何支持数据体系的运行,探讨结直肠肿瘤MDT数据体系的价值反馈,并提出对数据体系建立未来的展望。结果通过会诊、随访、院内临床的支持及合理地实现MDT模式中信息化流程的建设,数据体系运行能正常进行。结论数据体系作为整个结直肠肿瘤MDT项目的基础,能够通过医疗模式的改变表现出医疗价值和社会价值。     

2006年四川省大骨节病病情调查结果分析

目的 了解四川省大骨节病病情现状.方法 对20个大骨节病病区县进行儿童右手X线检查、成人大骨节病病情调查,采集儿童发样及当地主食粮样进行含硒量检测.结果 儿童临床检出率平均为1.02%;X线检出率平均为2.12%(0～13.16%),其中10.00%及以上的病区村有13个.成人临床检出率平均为27.02%(3.34%～53.08%),其中Ⅰ度16.73%、Ⅱ度7.79%、Ⅲ度2.49%.儿童发硒水平平均为(0.289±0.079)mg/kg,粮食硒水平平均为(0.023±0.021)mg/kg.结论 四川省大部分地区儿童大骨节病病情处于控制或基本控制范围,但局部地区尚处于较高新发病水平,成人大骨节病病情较为严重.     

Transplant data: sources, collection and research considerations, 2004

The process of collecting and analyzing transplant data is complex. Familiarity with how these data are collected is crucial to a thorough understanding of the information. This article focuses on available OPTN-SRTR data and the continuing evolution of data collection mechanisms; how that data collection system is improving the data quality and reducing the data collection burden; how additional ascertainment of outcomes both completes and validates existing data; and caveats that remain for researchers. This year's article focuses further on research considerations related to cohort choice, timing of data submission, and potential biases in follow-up data. Ongoing improvements in data collection timeliness and scope are covered. The impact of extra ascertainment of outcomes, particularly for post-transplant kidney graft failure from Medicare data, are also examined. A section on graft failure reporting among different sources traces the steps by which the SRTR reconciles different data sources in its analyses. It is important that those reading and conducting transplant research understand the origin, structure, and scope of the available data. All of these issues should be carefully considered when choosing cohorts and data sources for analysis.