The ABC of non-inferiority margin setting from indirect comparisons

In a non-inferiority trial to assess a new investigative treatment, there may need to be consideration of an indirect comparison with placebo using the active control in the current trial. We can, therefore, use the fact that there is a common active control in the comparisons of the investigative treatment and placebo. In analysing a non-inferiority trial, the ABC of: Assay sensitivity, Bias minimisation and Constancy assumption needs to be considered. It is highlighted how the ABC assumptions can potentially fail when there is placebo creep or a patient population shift. In this situation, the belief about the placebo response expressed in terms of a prior probability in Bayesian formulation could be used with the observed treatment effects to set the non-inferiority limit.     

The potential for bias in reporting of industry-sponsored clinical trials

Concerns about potentially misleading reporting of pharmaceutical industry research have surfaced many times. The potential for duality (and thereby conflict) of interest is only too clear when you consider the sums of money required for the discovery, development and commercialization of new medicines. As the ability of major, mid-size and small pharmaceutical companies to innovate has waned, as evidenced by the seemingly relentless decline in the numbers of new medicines approved by Food and Drug Administration and European Medicines Agency year-on-year, not only has the cost per new approved medicine risen: so too has the public and media concern about the extent to which the pharmaceutical industry is open and honest about the efficacy, safety and quality of the drugs we manufacture and sell. In 2005 an Editorial in Journal of the American Medical Association made clear that, so great was their concern about misleading reporting of industry-sponsored studies, henceforth no article would be published that was not also guaranteed by independent statistical analysis. We examine the precursors to this Editorial, as well as its immediate and lasting effects for statisticians, for the manner in which statistical analysis is carried out, and for the industry more generally.     

Unanticipated Educational Consequences of a Positive Parent‐Child Relationship

If today there exists a single transcendent idea about the family‐school connection, it is that a positive parent‐child relationship improves children's chances of succeeding in school. However, using data from the Texas Higher Education Opportunity Project (N = 5,836), we demonstrate that, although positive parent‐child relations are associated with better academic achievement in high school, they also are associated with an increased desire to live at home during college, which in turn decreases students' chances of enrolling in a 4‐year college. Furthermore, we replicated some of these associations using the National Longitudinal Study of Adolescent Health (N = 10,120), demonstrating that positive family dynamics can influence educational outcomes in potentially divergent and unanticipated directions.     

Marriage in the New Millennium: A Decade in Review

This review focuses on broad themes characterizing marital research in the past decade. In addition to continuing themes, such as a focus on conflict, violence, and impact on physical and mental health outcomes, we also address the impact of the Healthy Marriage Initiative on marital research and recent advances in methodology. We highlight an overarching theme that characterizes much of the literature: the importance of context in understanding marital outcomes and the impact of positive marital transactions and marital strengths. Given the increasing diversity of married couples, the attention given to context over the past decade has been timely and appropriate, providing an increasingly solid foundation for future research.     

Adolescents' attention to traditional and graphic tobacco warning labels: an eye-tracking approach

The objective of this study was determine if the inclusion of Canadian-style graphic images would improve the degree to which adolescents attend to, and subsequently are able to recall, novel warning messages in tobacco magazine advertising. Specifically, our goal was to determine if the inclusion of graphic images would (1) increase visual attention, as measured by eye movement patterns and fixation density, and (2) improve memory for tobacco advertisements among a group of 12 to 14 year olds in the western United States. Data were collected from 32 middle school students using a head-mounted eye-tracking device that recorded viewing time, scan path patterns, fixation locations, and dwell time. Participants viewed a series of 20 magazine advertisements that included five U.S. tobacco ads with traditional Surgeon General warning messages and five U.S. tobacco ads that had been modified to include non-traditional messages and Canadian-style graphic images. Following eye tracking, participants completed unaided- and aided-recall exercises. Overall, the participants spent equal amounts of time viewing the advertisements regardless of the type of warning message. However, the warning messages that included the graphic images generated higher levels of visual attention directed specifically toward the message, based on average dwell time and fixation frequency, and were more likely to be accurately recalled than the traditional warning messages.     

Determinants of Social Expenditure in Sri Lanka

The study examines the determinants of social expenditure in Sri Lanka for the period 1970–2010. The data are from a new data set assembled by the authors. The social spending data are collected from the Central Bank of Sri Lanka on education, health, and also on welfare spending. The study explains the determinants of social spending considering the demand‐side and the supply‐side driving forces and finds that inequality issues have been a major concern of social policy in Sri Lanka. Similarly, this study implies the influence of political behavior to satisfy voters as explained by the fiscal illusion theory. The globalization is not significant for social expenditure as commonly assumed in developed countries. Even the consequences of the self‐interested behavior of bureaucrats are not evident in the Sri Lankan welfare sector.     

Extending the Mann–Whitney–Wilcoxon rank sum test to longitudinal regression analysis

Outliers are commonly observed in psychosocial research, generally resulting in biased estimates when comparing group differences using popular mean-based models such as the analysis of variance model. Rank-based methods such as the popular Mann–Whitney–Wilcoxon (MWW) rank sum test are more effective to address such outliers. However, available methods for inference are limited to cross-sectional data and cannot be applied to longitudinal studies under missing data. In this paper, we propose a generalized MWW test for comparing multiple groups with covariates within a longitudinal data setting, by utilizing the functional response models. Inference is based on a class of U-statistics-based weighted generalized estimating equations, providing consistent and asymptotically normal estimates not only under complete but missing data as well. The proposed approach is illustrated with both real and simulated study data.