Blinded continuous monitoring in clinical trials with recurrent event endpoints

In studies with recurrent event endpoints, misspecified assumptions of event rates or dispersion can lead to underpowered trials or overexposure of patients. Specification of overdispersion is often a particular problem as it is usually not reported in clinical trial publications. Changing event rates over the years have been described for some diseases, adding to the uncertainty in planning. To mitigate the risks of inadequate sample sizes, internal pilot study designs have been proposed with a preference for blinded sample size reestimation procedures, as they generally do not affect the type I error rate and maintain trial integrity. Blinded sample size reestimation procedures are available for trials with recurrent events as endpoints. However, the variance in the reestimated sample size can be considerable in particular with early sample size reviews. Motivated by a randomized controlled trial in paediatric multiple sclerosis, a rare neurological condition in children, we apply the concept of blinded continuous monitoring of information, which is known to reduce the variance in the resulting sample size. Assuming negative binomial distributions for the counts of recurrent relapses, we derive information criteria and propose blinded continuous monitoring procedures. The operating characteristics of these are assessed in Monte Carlo trial simulations demonstrating favourable properties with regard to type I error rate, power, and stopping time, ie, sample size.     

川东北地区须家河组二段储层差异性分析

随着勘探程度的深入，为了扩大四川盆地天然气勘探领域、寻找新的勘探接替区，四川盆地的勘探区域由盆内逐渐向盆缘延伸。在这种背景下，川东北地区须家河组二段相继取得新的勘探成果，但在勘探开发过程中逐渐暴露了诸如区块之间气井产能差异大，储层的碎屑组分、结构及厚度、物性、孔隙结构差异明显等问题，制约了勘探开发的步伐。针对上述问题，根据岩芯观察描述、分析化验资料及测井解释成果，从沉积、成岩方面入手，对比剖析了川东北龙岗和营山地区须二段储层特征的差异性及其成因，认为远离物源区和高能水体的反复淘洗是造成储层差异性的首要因素，强烈的压实作用和多期石英加大对储层差异性起关键作用，自生绿泥石衬边胶结和长石选择性溶蚀最终决定了储层差异性。从而解释了气藏勘探开发中遇到的诸多问题，对有效指导该区的下一步勘探开发工作具有重要意义。     

丹巴土司制度发展历史考证

丹巴位于“藏彝走廊”的核心区域，其对汉藏民族关系、中央政权与边疆地区的稳定均具有重要影响。自忽必烈时期开始丹巴即开始实行土司制度直至新中国成立，研究丹巴的土司制度发展历史对梳理“藏彝走廊”民族关系及社会发展历史具有重要作用。本文对丹巴土司制度的发展历史进行了考证，并对其境内的四个土司的管辖范围、权力地位进行了梳理，以期对该地区历史发展研究提供一些参考与借鉴。     

China’s Choice of Analytical Models for Its Anti-Monopoly Law

Modern analytical models for anti-monopoly laws are a core element of the application of those laws. Since the Anti-Monopoly Law of the People’s Republic of China was promulgated in 2008, law enforcement and judicial authorities have applied different analytical models, leading to divergent legal and regulatory outcomes as similar cases receive different verdicts. To select a suitable analytical model for China’s Anti-Monopoly Law, we need to consider the possible contribution of both economic analysis and legal formalism and to learn from the mature systems and experience of foreign countries. It is also necessary to take into account such binding constraints as the current composition of China’s anti-monopoly legal system, the ability of implementing agencies and the supply of economic analysis, in order to ensure complementarity between the analytical model chosen and the complexity of economic analysis and between the professionalism of implementing agencies and the cost of compliance for participants in economic activities. In terms of institutional design, the models should provide a considered explanation of the legislative aims of the law’s provisions. It is necessary, therefore, to establish a processing model of behavioral classification that is based on China’s national conditions, applies analytical models using normative comprehensive analysis, makes use of the distribution rule of burden of proof, improves supporting systems related to analytical models and enhances the ability of public authorities to implement the law.     

影子银行、地方政府债务及金融发展动态关系研究——基于省级面板VAR模型

基于2004—2017年中国省级面板数据,运用面板向量自回归(PVAR)模型,使用系统GMM估计、脉冲响应函数、方差分解以及格兰杰因果关系检验等方法分析了影子银行、地方政府债务及金融发展之间的动态关系.结果表明:影子银行、地方政府债务与金融发展水平三者之间存在动态耦合关系.在地方政府融资能力受到约束的情况下,影子银行为地方政府提供了多元的融资方式,在增加政府融资能力的同时提升了政府债务水平;而地方政府债务需求显著推动了影子银行规模的快速发展.同时,影子银行过度扩张危害了金融市场的健康发展,降低金融发展水平,继而使地方政府的融资渠道受到约束.但金融发展并不能有效约束影子银行规模,原因在于,政府融资需求是影子银行的主要动力,若不能控制地方政府的借贷行为则无法从源头解决问题.监管机构在去杠杆的过程中,应该综合考虑影子银行与地方政府债务、金融发展之间的动态关系,如此才能够实现预期的政策效果.     

为合法经营活动而侵犯公民个人信息的刑法规制

最高人民法院、最高人民检察院《关于办理侵犯公民个人信息刑事案件适用法律若干问题的解释》第六条对为合法经营活动而侵犯公民个人信息行为进行独立规制,是新型犯罪罪状表述抽象化与罪状解释具体化、信息时代信息价值多元化与危害行为多样化、现代社会犯罪治理精细化与刑法评价精准化的内在要求.为合法经营活动而侵犯公民个人信息行为相关规范要素中的“为合法经营活动”应理解为主观超过要素,“获利五万元”应作严格解释,“曾因侵犯公民个人信息”应作广义解释,“其他情节严重”应包括信息数量标准.     

Managing the Risk of Aggressive Dog Behavior: Investigating the Influence of Owner Threat and Efficacy Perceptions

Aggressive behavior in pet dogs is a serious problem for dog owners across the globe, with bite injuries representing a serious risk to both people and other dogs. The effective management of aggressive behavior in dogs represents a challenging and controversial issue. Although positive reinforcement training methods are now considered to be the most effective and humane technique to manage the risk of aggression, punishment‐based methods continue to be used. Unfortunately, there has been little scientific study into the various factors influencing whether dog owners choose to use positive reinforcement techniques to manage aggression in their dogs. As such, current understanding of how best to encourage and support dog owners to use these methods remains extremely limited. This article uses a survey methodology based on protection motivation theory (PMT) to investigate the factors that influence owner use of positive reinforcement methods to manage aggressive behavior, in an attempt to understand potential barriers and drivers of use. In addition, the article provides an initial exploration of the potential role of wider psychological factors, including owner emotional state, social influence, and cognitive bias. Findings show that the perceived efficacy of positive reinforcement methods and the perceived ability of owners to effectively implement the technique are both key factors predicting future intentions and current reported use. Future interventions should focus on enhancing owner confidence in the effective use of positive reinforcement techniques across multiple scenarios, as well as helping owners manage their own emotional responses when they encounter challenging situations and setbacks.     

Comparison of labour and birth outcomes between nulliparous women who used epidural analgesia in labour and those who did not: A prospective cohort study

ObjectiveTo compare labour and birth outcomes between nulliparous women who used versus did not use intrapartum epidural analgesia.DesignProspective cohort study.SettingTwo maternity hospitals in Ireland.PopulationA total of 1221 nulliparous women who gave birth vaginally or by emergency caesarean section.MethodsMultinomial logistic regression was used to analyse categorical outcomes, with results presented as ratios of relative risks (RRR). For dichotomous outcomes we used logistic regression, with results presented as odds ratios (OR).Main outcome measuresMode of birth, IV syntocinon use, pyrexia (≥38 °C), antibiotic treatment, first stage labour ≥10 h, second stage labour ≥2 h, blood loss (≥500 mls, ≥1000 mls), perineal trauma. Neonatal outcomes included Apgar score ≥7 at 1 min and 5 min, admission to neonatal intensive care unit, and infant feeding method.ResultsWomen using EA were more likely to require a vacuum-assisted birth (RRR 3.35, p < 0.01) or forceps-assisted birth (RRR 11.69, p < 0.01). Exposure to EA was associated with significantly greater risk of ≥10 h first (OR 6.72, p = 0.01) and ≥2 h second (OR 2.25, p < 0.01) stage labour, increased likelihood of receiving IV syntocinon (OR 9.38, p < 0.01), antibiotics (OR 2.97, p < 0.01) and a greater probability of pyrexia (OR 10.26, p < 0.01). Women who used EA were half as likely to be breastfeeding at three months postpartum (OR 0.53, p < 0.01). No differences were observed between groups in neonatal outcomes.ConclusionsOur data shows significant associations between EA use and several intrapartum outcomes.     

Decision‐making under uncertainty in child protection: Creating a just and learning culture

The argument is made for having a positive error culture in child protection to improve decision‐making and risk management. This requires organizations to accept that mistakes are likely and to treat them as opportunities for learning and improving. In contrast, in many organizations, a punitive reaction to errors leads to workers hiding them and developing a defensive approach to their practice with children and families. The safety management literature has shown how human error is generally not simply due to a “bad apple” but made more or less likely by the work context that helps or hinders good performance. Improving safety requires learning about the weaknesses in the organization that contribute to poor performance. To create a learning culture, people need to feel that when they talk about mistakes or weak practice, there will be a constructive response from their organization. One aspect of reducing the blame culture is to develop a shared understanding of how practice will be judged and how those appraising practice will avoid the hindsight bias. To facilitate a positive error culture, a set of risk principles are presented that offer a set of criteria by which practice should be appraised.     

Price bias and common practice in option pricing

Generally, the semiclosed-form option pricing formula for complex financial models depends on unobservable factors such as stochastic volatility and jump intensity. A popular practice is to use an estimate of these latent factors to compute the option price. However, in many situations this plug-and-play approximation does not yield the appropriate price. This article examines this bias and quantifies its impacts. We decompose the bias into terms that are related to the bias on the unobservable factors and to the precision of their point estimators. The approximated price is found to be highly biased when only the history of the stock price is used to recover the latent states. This bias is corrected when option prices are added to the sample used to recover the states' best estimate. We also show numerically that such a bias is propagated on calibrated parameters, leading to erroneous values. The Canadian Journal of Statistics 48: 8–35; 2020 © 2019 Statistical Society of Canada