Inferences on the Means of Two Log-Normal Distributions: A Computational Approach Test

In this article, we propose a novel approach for testing the equality of two log-normal populations using a computational approach test (CAT) that does not require explicit knowledge of the sampling distribution of the test statistic. Simulation studies demonstrate that the proposed approach can perform hypothesis testing with satisfying actual size even at small sample sizes. Overall, it is superior to other existing methods. Also, a CAT is proposed for testing about reliability of two log-normal populations when the means are the same. Simulations show that the actual size of this new approach is close to nominal level and better than the score test. At the end, the proposed methods are illustrated using two examples.     

Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials

When a candidate predictive marker is available, but evidence on its predictive ability is not sufficiently reliable, all‐comers trials with marker stratification are frequently conducted. We propose a framework for planning and evaluating prospective testing strategies in confirmatory, phase III marker‐stratified clinical trials based on a natural assumption on heterogeneity of treatment effects across marker‐defined subpopulations, where weak rather than strong control is permitted for multiple population tests. For phase III marker‐stratified trials, it is expected that treatment efficacy is established in a particular patient population, possibly in a marker‐defined subpopulation, and that the marker accuracy is assessed when the marker is used to restrict the indication or labelling of the treatment to a marker‐based subpopulation, ie, assessment of the clinical validity of the marker. In this paper, we develop statistical testing strategies based on criteria that are explicitly designated to the marker assessment, including those examining treatment effects in marker‐negative patients. As existing and developed statistical testing strategies can assert treatment efficacy for either the overall patient population or the marker‐positive subpopulation, we also develop criteria for evaluating the operating characteristics of the statistical testing strategies based on the probabilities of asserting treatment efficacy across marker subpopulations. Numerical evaluations to compare the statistical testing strategies based on the developed criteria are provided.     

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.     

Changes in work and care trajectories during the transition to motherhood

In most mid- and high-income countries, there have been significant demographic, structural, and cultural changes in the past decades. However, we know little about how these changes have shaped women's work patterns during a key life stage: the transition to motherhood. Using longitudinal data from Chile, covering over 30 years of employment histories and three periods of first births (1980–2010), I conduct sequence analysis to identify women's work-care trajectories during an eight-year period of the transition to motherhood. Over time, I find that continuous care work at home has declined, for which education plays a key role, while the chances of working continuously have not changed over time. Instead, I find an increasing trend of unsteady paths that combine paid work with either caretaking or unemployment. I discuss how these changes, as well as their association with education, have important implications for both gender and social inequality.     

Modifications of sequential designs in bioequivalence trials

Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd.     

Robust Designs in Generalized Linear Models: A Quantile Dispersion Graphs Approach

This article studies design selection for generalized linear models (GLMs) using the quantile dispersion graphs (QDGs) approach in the presence of misspecification in the link and/or linear predictor. The uncertainty in the linear predictor is represented by a unknown function and estimated using kriging. For addressing misspecified link functions, a generalized family of link functions is used. Numerical examples are shown to illustrate the proposed methodology.     

Holistic trajectories: a study of combined employment, housing and family careers by using multiple-sequence analysis

Summary.  Social science applications of sequence analysis have thus far involved the development of a typology on the basis of an analysis of one or two variables which have had a relatively low number of different states. There is a yet unexplored potential for sequence analysis to be applied to a greater number of variables and thereby a much larger state space. The development of a typology of employment experiences, for example, without reference to data on changes in housing, marital and family status is arguably inadequate. The paper demonstrates the use of sequence analysis in the examination of multivariable combinations of status as they change over time and shows that this method can provide insights that are difficult to achieve through other analytic methods. The data that are examined here provide support to intuitive understandings of clusters of common experiences which are both life course specific and related to socio-economic factors. Housing tenure is found to be of key importance in understanding the holistic trajectories that are examined. This suggests that life course trajectories are sharply differentiated by experience of social housing.     

家庭暴力的原因及预防对策探微

目前,家庭暴力已成为越来越不容忽视的社会问题和影响社会稳定的不安定因素。其产生的原因既受到封建专制主义的文化传统和宗法等级制度的影响,也与当前社会竞争加剧给人们造成的巨大心理压力以及其他因素有关。其预防对策是要逐渐消除家庭暴力正常化的观念,鼓励被害人增强抗争意识,更要借助于公安机关的预防和打击。     

左思风力之成因初探

西晋诗人左思的诗风在西晋文坛上独树一帜，称之为“左思风力”，前人对此有较多地论述，然而就诗风形成的原因却缺乏深入地探究。本文试图从社会时代背景、家庭因素、性格特征三个方面对此加以分析，旨在能够更好地把握左思其人及其诗风。     

"民官比"不是影响政治体制改革的重要因素

在政治体制改革中,公务员或国家干部人数的多少并不是一个关键因素,重要的是必须把政府的社会定位(包括角色、权力和责任)划分清楚。与世界各国相比较,我国197.69∶1(或116.27∶1)的“民官比”并不高,因此,今后的政治体制改革不需要再把精力集中在“精简”上,而应按邓小平的部署,首先把党政分开和权力下放的工作做好。毕竟“小政府”是指“政府权力受限制”,而非“人数更少”;“大社会”是指“社会权利更广泛”,而非“人数更多”。