Randomized,double-blind,placebo-controlled,safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers

A new anthrax vaccine that could accelerate the immune response and possibly reduce the number of injections needed for protection would be desirable in a post-exposure setting.     

Vaccine hesitancy around the globe: Analysis of three years of WHO/UNICEF Joint Reporting Form data-2015–2017

In order to gather a global picture of vaccine hesitancy and whether/how it is changing, an analysis was undertaken to review three years of data available as of June 2017 from the WHO/UNICEF Joint Report Form (JRF) to determine the reported rate of vaccine hesitancy across the globe, the cited reasons for hesitancy, if these varied by country income level and/or by WHO region and whether these reasons were based upon an assessment. The reported reasons were classified using the Strategic Advisory Group of Experts (SAGE) on Immunization matrix of hesitancy determinants (www.who.int/immunization/sage/meetings/2014/october/SAGE_working_group_revised_report_vaccine_hesitancy.pdf). Hesitancy was common, reported by >90% of countries. The list of cited reasons was long and covered 22 of 23 WHO determinants matrix categories. Even the most frequently cited category, risk- benefit (scientific evidence e.g. vaccine safety concerns), accounted for less than one quarter of all reasons cited. The reasons varied by country income level, by WHO region and over time and within a country. Thus based upon this JRF data, across the globe countries appear to understand the SAGE vaccine hesitancy definition and use it to report reasons for hesitancy. However, the rigour of the cited reasons could be improved as only just over 1/3 of countries reported that their reasons were assessment based, the rest were opinion based. With respect to any assessment in the previous five years, upper middle income countries were the least likely to have done an assessment. These analyses provided some of the evidence for the 2017 Assessment Report of the Global Vaccine Action Plan recommendation that each country develop a strategy to increase acceptance and demand for vaccination, which should include ongoing community engagement and trust-building, active hesitancy prevention, regular national assessment of vaccine concerns, and crisis response planning (www.who.int/immunization/sage/meetings/2017/october/1_GVAP_Assessment_report_web_version.pdf).     

基于Excel的随机模拟在《医药数理统计》教学中的应用

随机模拟是统计学研究中的一种常用方法,将其运用到医药数理统计教学中,有很好的演示效果。以Excel软件里的随机数发生器为基础,进行简单的随机模拟。通过几个例子,说明了随机模拟在教学中可以起到模拟随机试验、验证重要结论和解释重要概念等作用。     

Evaluating the effects of an Internet education programme on newborn care in Taiwan

Aim. The objectives of this study were to evaluate an Internet education programme provided to primigravida in the third trimester of pregnancy with the aim of enhancing mothers’ knowledge about newborn care and increasing their maternal confidence. Background. Shorter hospital stays have had an impact on the traditional role of mother–baby nurses in providing education about parenting to their parturient women. Internet education is an efficient way to provide nursing instruction. Design. A randomised controlled trial was used. A total of 118 women receiving prenatal care in a hospital clinic who met study criteria and who consented were assigned randomly to intervention and control groups. The study was conducted at a hospital in Taiwan. Methods. The target population was women at 32–34 weeks gestation, using the Internet on a regular basis. The primigravida were randomly assigned to either the control group (n = 57) or the experimental group (n = 61). Two primary outcome measures were newborn‐care knowledge and maternal confidence. Results. The changes in newborn‐care knowledge were 7·21 for the experimental group, compared with 1·95 for the control group; the difference between the least‐squares means computed by ancova was 5·73 and statistically significant (p < 0·001). The changes in maternal confidence were 8·46 for the experimental group and 3·05 for the control group; the difference between the least‐squares means computed by ancova was 5·94 and statistically significant (p < 0·001). Conclusion. Results suggest that Internet education about newborn care may contribute to greater care knowledge and maternal confidence. Relevance to clinical practice. Internet newborn‐care education programmes can achieve success in promoting newborn care and provide health professionals with evidence‐based intervention.     

Comorbidities Drive the Majority of Overall Mortality in Low-Risk Mucinous Pancreatic Cysts Under Surveillance

Background & AimsThe Charlson Comorbidity Index (CACI) has been suggested as a tool to determine comorbidity burden and guide management for patients with mucinous pancreatic cysts (Intrapapillary Mucinous Neoplasms and Mucinous Cystic Neoplasms), but has not been studied well among “low-risk” mucinous pancreatic cysts i.e. without worrisome features (WF) and high-risk stigmata (HRS). This study sought to determine the comorbidity burden among surveillance population of low-risk pancreatic cysts and provide their follow-up mortality outcomes.MethodsA single center study retrospectively reviewed a prospective pancreatic cyst database and included individuals with low-risk cysts undergoing serial imaging during 2016. Electronic medical records were reviewed to determine their baseline age-adjusted CACI (age-CACI). After 4 years, their progression to WF, disease specific (pancreatic malignancy-related, DSM), extra-pancreatic (EPM), and overall mortalities (OM) were determined using Kaplan-Meir Survival Analysis.Results502 individuals underwent prospective surveillance. The study included 440 individuals with low-risk suspected or presumed mucinous cysts and excluded 50 and 12 individuals with WF and HRS respectively. Over a median follow-up of 56 months, 12 WF progressions, 2 DSMs, 42 EPMs, and 44 OMs were observed. Baseline age-CACI had good predictive capacity for 4-year EPM (Area-Under Curve: 0.87; p< .0001). The median age-CACI of 4 enabled cohort stratification into Low (age-CACI <4) and High CACI (age-CACI ≥4) groups. A significantly higher OM (p< .001) was observed among the High CACI group as compared to the Low CACI group.ConclusionThrough real-time application of CACI to patient outcomes, our analysis supports incorporation of this comorbidity assessment tool in making shared surveillance decisions among low-risk pancreatic cyst population.     

Atorvastatin Reduces First and Subsequent Vascular Events Across Vascular Territories: The SPARCL Trial

BackgroundIn the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, atorvastatin was compared with placebo in 4,731 participants with recent stroke or transient ischemic attack and no known coronary heart disease. Atorvastatin reduced the first occurrence of stroke and the first occurrence of a composite of vascular events.ObjectivesThe aim of this post hoc analysis was to assess the occurrence of all (first and subsequent) vascular events and the effect of atorvastatin to reduce these events by vascular territory (cerebrovascular, coronary, or peripheral) in SPARCL.MethodsTreatment effects on total adjudicated vascular events, overall and by vascular territory, were summarized by marginal proportional hazards models. Vascular event rates were estimated for each treatment group with cumulative incidence functions.ResultsThe placebo group had an estimated 41.2 first and 62.7 total vascular events per 100 participants over 6 years. There were 164 fewer first and 390 fewer total vascular events in the atorvastatin group (total events hazard ratio: 0.68; 95% confidence interval: 0.60 to 0.77). The total events reduction included 177 fewer cerebrovascular, 170 fewer coronary, and 43 fewer peripheral events. Over 6 years, an estimated 20 vascular events per 100 participants were avoided with atorvastatin treatment.ConclusionsIn participants with recent stroke or transient ischemic attack, the total number of vascular events prevented with atorvastatin was more than twice the number of first events prevented. Total event reduction provides a comprehensive metric to capture the totality of atorvastatin clinical efficacy in reducing disease burden after stroke or transient ischemic attack. (Lipitor in the Prevention of Stroke, for Patients Who Have Had a Previous Stroke [SPARCL]; NCT00147602)