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.     

Talking Prose All These Years: Agent‐Based Modeling as Process‐Oriented Analysis

This article considers the implications of an approach to computer simulation called agent‐based modeling for process‐oriented analysis. It argues that many theoretical and methodological debates found in the latter field can be effectively advanced by the former. The argument is presented and then extended using a ubiquitous agent‐based model proposed to improve understanding of ethnic residential segregation. The argument has three strands. The first is that theoretical and methodological debates are unlikely to progress unless they can be “cashed out” empirically. The second is that agent‐based modeling (and its distinctive methodology) has capabilities to do this that existing research methods lack and, in fact, that agent‐based models are a natural way to represent “social process” as apparently conceived by process‐oriented analysis. The third is that possibilities exist for productive synthesis between agent‐based modeling and process‐oriented analysis with the former clarifying, instantiating, and perhaps even testing notions of process developed by the latter.     

Estimating household structure in ancient China by using historical data: a latent class analysis of partially missing patterns

Summary.  Social data often contain missing information. The problem is inevitably severe when analysing historical data. Conventionally, researchers analyse complete records only. Listwise deletion not only reduces the effective sample size but also may result in biased estimation, depending on the missingness mechanism. We analyse household types by using population registers from ancient China (618–907 AD) by comparing a simple classification, a latent class model of the complete data and a latent class model of the complete and partially missing data assuming four types of ignorable and non-ignorable missingness mechanisms. The findings show that either a frequency classification or a latent class analysis using the complete records only yielded biased estimates and incorrect conclusions in the presence of partially missing data of a non-ignorable mechanism. Although simply assuming ignorable or non-ignorable missing data produced consistently similarly higher estimates of the proportion of complex households, a specification of the relationship between the latent variable and the degree of missingness by a row effect uniform association model helped to capture the missingness mechanism better and improved the model fit.     

Quasi-maximum likelihood estimation and inference in dynamic models with time-varying covariances

We study the properties of the quasi-maximum likelihood estimator (QMLE) and related test statistics in dynamic models that jointly parameterize conditional means and conditional covariances, when a normal log-likelihood os maximized but the assumption of normality is violated. Because the score of the normal log-likelihood has the martingale difference property when the forst two conditional moments are correctly specified, the QMLE is generally Consistent and has a limiting normal destribution. We provide easily computable formulas for asymptotic standard errors that are valid under nonnormality. Further, we show how robust LM tests for the adequacy of the jointly parameterized mean and variance can be computed from simple auxiliary regressions. An appealing feature of these robyst inference procedures is that only first derivatives of the conditional mean and variance functions are needed. A monte Carlo study indicates that the asymptotic results carry over to finite samples. Estimation of several AR and AR-GARCH time series models reveals that in most sotuations the robust test statistics compare favorably to the two standard (nonrobust) formulations of the Wald and IM tests. Also, for the GARCH models and the sample sizes analyzed here, the bias in the QMLE appears to be relatively small. An empirical application to stock return volatility illustrates the potential imprtance of computing robust statistics in practice.     

Campus attitudes toward alcohol and drugs in a deep southern university.

In our zeal to deal with alcohol and drug abuse, we may have a distorted picture of what the majority of college students actually think about alcohol and drug use. Students in this study done at a public university located in the Deep South report being generally intolerant of substance abuse.     

Every Dot has a Meaning

Family therapy in Australia has recently begun a conversation with the indigenous people of this country. Part of this dialogue has involved family therapists listening to the stories of violence and oppression perpetrated against the Aboriginal people under the name of “protection”. This article is part of the ongoing exchange between family therapists and Kooris documenting the suffering of “the stolen generation”. Here two young people removed from their families as small children and raised in the same Aboriginal children's home, speak personally through their art, of an agonising search for family and cultural identity.     

Household debt and financial assets: evidence from Germany, Great Britain and the USA

Summary.  We explore the determinants of debt, financial assets and net worth at the household level by using survey data for Germany, Great Britain and the USA. To identify which households are potentially vulnerable to adverse changes in the economic environment, we also explore the determinants of a range of measures of financial pressure: the probability that a household has negative net worth; the debt-to-income ratio; mortgage income gearing; the saving-to-income ratio. Our empirical findings suggest that the poorest and the youngest households are the most vulnerable to adverse changes in their financial circumstances.     

Rural/Urban Differences in Child Growth and Survival in Bolivia

Abstract Using data from a national survey in Bolivia and from a regional sample of poor communities in two regions of Bolivia, we model the effects of community conditions, household characteristics, and social relations on child health as measured by child mortality and stunted growth. Based on national data, children in rural areas are twice as likely to die before the age of two than are children in large cities, and about one‐third of the children in rural areas are stunted. Including measures of community, household, and maternal characteristics accounts for at least two‐thirds of the urban/rural difference in child health. We conclude that expansion of health services, improvements in household and community sanitation, and socioeco‐nomic development are all needed to overcome the rural disadvantage in child health.