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1.
《Vaccine》2016,34(51):6626-6633
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. 相似文献
2.
Sarah Hallas Andrea Nelson Susan O'Meara Una Adderley Pauline Meskell Jane Nixon Aonghus O'Loughlin Sebastian Probst Wael Tawfick Thomas Wild Georgina Gethin 《Journal of tissue viability》2021,30(3):317-323
BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports. 相似文献
3.
安惠侯 《齐齐哈尔医学院学报》2006,(1)
美国在中东遇到大麻烦,主要战略目标未能实现。伊拉克安全形势持续严峻,巴以和谈停滞不前,伊朗核问题难以解决,压叙利亚屈服迄未奏效,恐怖活动越反越多,大中东改造计划受挫。美遇到的困难未超出其承受能力,美国在中东仍居主导地位,美中东政策在手法和策略上有所调整,实质上并无变化。 相似文献
4.
分析了GELOGIQ 400B超机不能启动的故障,经对电源、主板、硬盘的维修,机器恢复正常。 相似文献
5.
论“恐伤”心理的基因定势表达 总被引:3,自引:0,他引:3
本文在基因定势表达研究概况基础上,列举0MIM上部分与恐惧等心理因素定势的基因与疾病,进而探讨心理、基因定势表达与精神病的关系。 相似文献
6.
Dennis A. Revicki Harris Allen Kathleen Bungay Gordon H. Williams Milton C. Weinstein 《Journal of clinical epidemiology》1994,47(12):1333-1342
We examined the discriminant ability and responsiveness of the General Well-Being Adjustment Scale in patients enrolled in a randomized clinical trial of antihypertensive therapy. We also tried to translate the effects of physical symptoms on general well-being. This secondary analysis used demographic, clinical, physical symptom, and general well-being data for 545 white, male hypertensive patients. General well-being was measured by the General Well-Being Adjustment Scale (GWB) collected on 2 occasions over 8 weeks of treatment. Patients with any one of 14 physical symptoms or problems, compared to those without symptoms, had lower GWB scores (p < 0.003 to p < 0.0001). Decreases of 2.83–8.76 points in GWB scores were observed in patients developing physical symptoms over the 8 week study period (p < 0.05 to p < 0.0001). These effects were demonstrated in patients developing cold sensitivity, sexual problems, chest pain, shortness of breath, loss of taste, nausea, hot or cold spells, numbness and tingling, dry mouth, blurred vision, and dizziness. We conclude that the GWB is responsive to clinically meaningful changes in symptoms and may provide a more complete evaluation of the effects of medical treatment. The GWB is a valid and responsive measure of health status outcomes in the evaluation of antihypertensive treatment. 相似文献
7.
元数据DC与MARC的互换 总被引:3,自引:0,他引:3
介绍了元数据及MARC,并探讨运用表格形式表示二者的映射关系及互换性和中文元数据的应用问题。 相似文献
8.
9.
本研究测定了荔枝果实发育期间内源激素含量的动态。结果表明果实发育前期细胞分裂素(CTK),生长素(IAA)含量较高;中期乙烯(Eth),赤霉素(GA),的含量较高,这与果实的生长发育及落果有密切相关。同时,果实发育前期应用外源CTK、中期应用GA、处理果穗可显著提高产果率。 相似文献
10.
Karl‐Jürgen Br Stanislaw Brehm Michael Karl Boettger Gerd Wagner Silke Boettger Heinrich Sauer 《European Journal of Pain》2006,10(5):467-471
An altered perception of pain has been described for several psychiatric disorders. To date the influence of adjustment disorders (AD) on pain perception has not been described. Here, we investigated perception of experimentally induced pain in 15 patients suffering from AD (subtype with depressive symptoms) and controls matched for age and sex. Thresholds and tolerances were assessed for thermal and electrical pain on both sides of the body. We found an overall increase of pain thresholds and tolerances in AD patients as compared to controls, predominately on the right side of the body. Analogue findings have been reported for pain perception in major depressive disorder (MDD). Of the data obtained, only thermal pain threshold on the right arm correlated with the severity of depressive symptoms. Although the underlying pathology is elusive it is likely that the mechanisms for reduced pain sensitivity are comparable in MDD and AD. 相似文献