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.     

Hygiene in Operationsabteilungen – Empfehlungen des Nationalen Referenzzentrums für Krankenhaushygiene

Zusammenfassung. Viele Hygienema?nahmen in Operationsabteilungen sind durch wissenschaftliche Untersuchungen nicht belegt. Die in dieser Arbeit vom Nationalen Referenzzentrum für Krankenhaushygiene, das 1996 vom Bundesgesundheitsministerium eingerichtet wurde, zusammengestellten Empfehlungen stützen sich auf die Ergebnisse wissenschaftlicher Untersuchungen und trennen so die unbedingt notwendigen von den weniger bzw. nicht sinnvollen Ma?nahmen.

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Summary. Many hygienic procedures performed in operation units are not supported by scientific investigations. The following recommendations by the National Reference Center for Hospital Epidemiology, founded by the German Ministry of Health in 1996, are based on the scientific literature and separate necessary from less necessary and unnecessary procedures.

     

Myocardial sestamibi single-photon emission tomography: Variations in reference values with gender, age and rest versus stress?

Reference data files support the evaluation of myocardial perfusion single-photon emission tomography (SPET). The aim of this study was to create a large reference data base for technetium-99m sestamibi SPET, age and gender matched to the general patient population. One hundred and twenty-eight healthy volunteers (76 males and 52 females) with a likelihood of coronary artery disease of less than 5% underwent rest and maximal exercise^99mTc-sestamibi SPET with a 2-day protocol and 180° elliptical rotation. The normalized activity values of^99mTc-sestamibi in the inferior wall differed significantly between men and women. Age variations were found for men in the anterior wall. Normalized activity values in all four walls were strikingly similar during rest and stress. Our results suggest that the use of reference files in^99mTc-sestamibi SPET requires a gender- and, for males, possibly an age-matched reference population. Different reference files at rest and during stress might not be necessary.     

18F-FDG PET/CT显像正常腹部消化器官的标准摄取值分析

目的分析^18F-脱氧葡萄糖（FDG）PET/CT显像正常腹部消化器官标准摄取值（SUV）的变化范围.方法60例要求行PET/CT检查的健康人,按体重7.77 MBq/kg静脉注射^18F-FDG,PET采集为三维模式,每个床位3 min.对腹部肝、胆囊、脾、胰腺、胃、盲肠、结肠和直肠进行半定量分析,各器官的SUV由横断面测量,准确定位时参考同机CT.结果正常腹部消化器官^18F-FDG摄取有较大差异,其中摄取较高者SUV平均值（SUVavg）依次为直肠、肝、乙状结肠、回盲部和脾、升结肠,SUV最大值（SUVmax）依次为直肠、乙状结肠、肝、回盲部、升结肠、脾.结论PET/CT显像能较好地识别腹部消化器官;熟悉正常腹部消化器官^18F-FDG摄取的差异,对判读图像十分重要.     

粤西地区血小板聚集率正常人群参考范围的建立

目的 :为粤西地区血小板聚集率的临床检测提供参考标准。方法 :采用北京普利生仪器有限公司生产的 L BY-NJ型多功能血液凝聚仪。以终浓度 2 .5 μmol/ L ADP为诱导剂 ,对 6 38例正常人按年龄、性别分组 ,分别检测血小板 1m in、3min、5 min及 Max聚集率 ,并进行统计学分析。结果 :各年龄组男女性别 PAG无显著性差异 ( P>0 .0 5 ) ;小于 35岁年龄组与 35～ 5 5岁年龄组比较 ,PAG无显著性差异 ( P>0 .0 5 ) ;35～ 5 5岁年龄组与大于等于 5 5岁年龄组比较 ,1min及 3mim PAG存在显著性差异 ( P<0 .0 5 )、5 min及 Max PAG相差非常显著 ( P<0 .0 1) ;小于 35岁年龄组与大于等于5 5岁年龄组比较 ,PAG有非常显著性差异 ( P<0 .0 1) ;小于 5 5岁年龄组与大于等于 5 5岁年龄组比较 ,PAG差异有极显著性意义 ( P<0 .0 1或 P<0 .0 0 1)。结论 :5 5岁以上年龄组与 5 5岁以下年龄组的 PAG结果 ,可作为粤西地区同类方法PAGT的正常参考值供临床检测参考     

深圳宝安3～7岁健康幼儿血清糖、离子、非蛋白含氮类化合物表达水平观察

目的观察深圳宝安3～7岁健康幼儿血清糖、离子、非蛋白含氮类化合物表达水平。方法采用OLRPUSAU-640全自动生化仪及OLRPUS诊断试剂、东欧生物诊断试荆，检测316例体检健康幼儿血清中Ca^＋＋、Mg^＋＋、P^＋＋＋、GLU、BUN、Cr、UA的含量。结果①．1组与4组及2组与3、4组Ca^＋＋组间方差分析，差异有统计学意义，P〈0.05。②．1组与2、3、4组Cr组间方差分析，差异有统计学意义P〈0．05。而Mg^＋＋、P^＋＋＋、GLU、BUN、UA组间方差分析差异无统计学意义，P〉0．05。结论笔者证实了3～4岁健康幼儿与6～7岁健康幼儿及4～5岁健康幼儿与5～7岁健康幼儿血清Ca^＋＋表达水平有差异。也证实了3～4岁健康幼儿与4～7健康幼儿Cr含量存在差异。由此可见，3～7岁健康幼儿建立自己的参考值是必要的。     

UF-100型全自动尿液沉渣检测仪测定参考范围调查

目的　确定UF - 10 0型全自动尿液沉渣检测仪检测健康人尿沉渣检测的参考值范围。方法　用UF - 10 0型全自动尿液沉渣检测仪随机检测 5 2 0例健康人不离心尿液标本 ,对尿液沉渣进行分析。结果　尿液中红细胞 (RBC)、白细胞 (WBC)、上皮细胞 (EC)、管型 (CAST)各年龄组之间检测值经 F 检验 ,差异无显著意义 (P >0 .0 5 ) ,但男、女性别之间差异有显著意义 (P <0 .0 5 )。结论　尿液RBC、WBC、EC的多少与年龄无关 ,但与性别有关。健康人参考值的确立 ,为尿液常规检验定量标准化和临床应用提供了依据     

A two-dimensional electrophoresis reference map of human ovary

The ovary plays a central role in oogenesis and gonadal hormone secretion. Proteomic analysis is a valuable approach for gaining an increased understanding of the molecular nature of the ovary. In this work, two-dimensional electrophoresis for protein separation followed by matrix-assisted laser desorption/ionization mass spectrometry and database searches, identified 231 protein spots corresponding to 138 individual proteins that were found in gels representing both the follicular and luteal phases. The data were used to construct a database online (). The identified proteins were functionally classified into seven groups: (1) cell signaling/communication, (2) cell division, (3) gene/protein expression, (4) metabolism, (5) cell structure and motility, (6) cell/organism defense, and (7) unclassified. Among the proteins identified, 47% had not been previously reported in the human ovary. In addition, a number of disease-related proteins were identified in this protein map, including some cancer- and polycystic ovarian syndrome-related proteins. Two proteins with phosphorylation were verified by Western blot analysis. Comparison of protein abundance between follicular and luteal stages produced seven protein spots that had been identified in our database. This study provides a preliminary reference map of normal human ovary that will form a basis for comparative studies on normal and pathological conditions of the human ovary and may serve as a potential tool for clinical diagnosis, therapeutics, and prognosis.Electronic Supplementary Material Supplementary material is available in the online version of this article at L. Wang and Y.-F. Zhu contributed equally to this work     

Task-dependent mixtures of coordinate systems in visuomotor transformations

In two experiments the involvement of relative and fixed coordinate systems in visuomotor transformations was examined. The experimental task required the successive performance of two movements in each trial, which had to “correspond” to different visual stimuli. One kind of visual display indicated target positions by way of different horizontal positions of a vertical line on a monitor (position mode), while the other indicated movement amplitudes by way of different lengths of a horizontal line (amplitude mode). Formal analysis of variances and covariances of successive individual movements led to the conclusion that in the position mode visuomotor transformations were based on a mixture of relative and fixed coordinate systems, while in the amplitude mode only a relative coordinate system was involved. Thus, visuomotor transformations can be characterized as mixtures of different coordinate systems, and their respective weights in the mixtures are task-dependent. Received: 18 March 1997 / Accepted: 25 September 1997