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.     

Gender and the 'New Paradigm' of Health

This article provides a critical review of literature on the relationship between gender and the 'new paradigm' of health. An overview of the feminist critique of health is given, from the Women's Health Movement of the late 1960s and early feminist debates about medicalisation, to more recent discussions about structural inequalities between men and women, eating disorders, and AIDS. I then go on to explore the feminist response to the so-called 'new paradigm' of health (an approach that emphasises health promotion, individual responsibility for health, and body-monitoring). Arguments that health promotion initiatives target women and confirm their position as principal guardians of health within the family are considered, as well as literature on the breast cancer awareness campaign. I then explore the growing body of literature on masculinity and health, and its account of the relationship between gender and current ideas about healthiness. Finally, I offer up some suggestions for the direction a new feminist critique of health might take.     

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.     

Dementia Problem Behavior and the Production of Informal Caregiving Services

Informal caregivers of individuals with Alzheimer's disease spend a considerable amount of time providing care. In this paper, we use Grossman's health production and Becker's time allocation models to develop a model of informal care provision to elderly dementia patients. In our model, time inputs produce caregiving services, which provides utility to the caregiver, but reduces leisure. We assume that time is less productive of services on the margin as the disease progresses. In this framework, an increase in patients' disease severity does not necessarily increase informal caregiver time input. The cost of formal care establishes a reservation price for informal caregiving. When the costs of informal caregiving rise above this reservation level, the patient is institutionalized. We test empirically the effect of deterioration in the patients' condition, proxied by both disease severity and dementia problem behavior, on informal caregiving time. We find that dementia-related problem behaviors and functional limitations significantly increase inputs of informal caregiving time. Patients' problem behavior exerts a modifying effect on functional limitations, and patients' comorbidities have no effect on informal caregiving time.     

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.     

Using the lessons learned from US and English law to create a regulatory framework for charities in evolving democracies

The evolving democracies of Eastern Europe and the former USSR republics are keenly interested in establishing charities. They have little law on this issue because their former governments did not encourage the development of charities. This article compares US and English regulation of charities and proposes a regulatory framework based on what the authors believe are the best attributes of both. Although the framework is based on the common law system, it can be adapted to the civil law systems of the Eastern European nations and the former USSR republics. The article includes such issues as developing a body of law, tax relief and creating a regulatory agency.Mr Hopkins is a lawyer with Powers, Pyles & Sutter, 1275 Pennsylvania Ave., N.W., Washington, D.C. 20007, and author ofThe Law of Tax-Exempt Organizations (1992a).Ms Moore is also a lawyer, 5908 N. 35th St., Arlington, Virginia 22207.The authors would like to thank Mssrs Kersi Shroff and Stephen F. Clarke, Senior Legal Specialists, American-British Law Division, Library of Congress, and Mr. William H. Morris, an attorney at Steptoe & Johnson, Washington, D.C., for their kind assistance during the researching of this article.     

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.     

A simultaneous-equations model of the relationship between public sector bargaining legislation and unionization

This paper estimates a simultaneous-equations model with public sector bargaining laws and union membership treated as jointly-determined variables. The extent of public sector unionization has a significant positive influence on the passage of prolabor bargaining legislation and bargaining legislation has strong, independent effects on the extent of public sector unionization. We gratefully acknowledge the research support provided by Minbo Kim and Parisun Chantonahom.     

In Whose Backyard?: Concern About Siting a Nuclear Waste Facility*

Proponents of hazardous and nuclear waste depositories label opponents to local siting of such facilities “NIMBYs” (Not In My Backyard). This study assesses the extent to which the NIMBY label and the strategies of industry proponents to reduce opposition function on a reasonable set of assumptions. Using survey data and multiple regression techniques, the levels of concern of residents living in the county selected as the site of a low level radioactive waste disposal facility (imminent threat condition) are compared with a statewide sample (hypothetical threat condition). Consistent with proponents' theoretical assumptions, the levels of concern are greater for respondents under conditions of imminent threat than of hypothetical threat. However, within the host county, levels of concern are lowest, albeit most polarized, in the community closest to the proposed site. A conflict theory approach enhances an understanding of these findings by suggesting that within the most proximate community levels of concern are lowest for citizens who stand to gain the most economic benefits from the facility but highest for those citizens who are least likely to derive tangible gains.     

Outcome Expectations in Prolonged Conflicts: Perceptions of Sense of Control and Relative Deprivation

How do feelings of deprivation and a sense of control influence future expectations on the parts of Jews, Arabs, and Palestinians? We assumed that all non-Jews, but especially Palestinians, are discriminated against in Israel and that awareness of discrimination may have two related effects. First, it may strengthen feelings of relative deprivation among members of the group being discriminated against. Second, awareness of discrimination may lower the sense of control among the disadvantaged, because their life experiences diminish their ability to exercise authority and influence in order to direct and regulate their choices. However, when analyzing expectations, previous studies focused either on relative deprivation or on sense of control, not on both. Assuming that the two are related, we included both to analyze outcome expectations. We also present an alternative approach to sense of control to include an expressive dimension of control in addition to the traditional instrumental dimension. As expected, the findings indicate that Palestinians have the strongest feelings of personal deprivation and the lowest future expectations. Jews feel the lowest personal deprivation and have the highest expectations.