Statistics for weighing benefits and harms in a proposed genetic substudy of a randomized cancer prevention trial

Summary.  When evaluating potential interventions for cancer prevention, it is necessary to compare benefits and harms. With new study designs, new statistical approaches may be needed to facilitate this comparison. A case in point arose in a proposed genetic substudy of a randomized trial of tamoxifen versus placebo in asymptomatic women who were at high risk for breast cancer. Although the randomized trial showed that tamoxifen substantially reduced the risk of breast cancer, the harms from tamoxifen were serious and some were life threaten-ing. In hopes of finding a subset of women with inherited risk genes who derive greater bene-fits from tamoxifen, we proposed a nested case–control study to test some trial subjects for various genes and new statistical methods to extrapolate benefits and harms to the general population. An important design question is whether or not the study should target common low penetrance genes. Our calculations show that useful results are only likely with rare high penetrance genes.     

Is CSR the panacea for SMEs? A study of socially responsible SMEs during economic crisis

There is increasing research attention as to how SMEs might realize corporate social responsibility opportunities. Most studies focus on the pursuance of responsible business strategies that result in favourable business outcomes. This study investigates SMEs who actively participate in CSR activities in a south-eastern European country during the economic crisis of the Eurozone. Data collected reveals that stakeholder salience and proximity moderate the relationship between CSR and financial performance. The context of this study is important as it addresses the paucity of research carried out in countries during economic crisis and sheds light on the positive aspects of CSR practices adopted during crisis.     

The ascendancy of primary care: permanent or temporary?

The conventional wisdom strongly suggests a health care provider food chain for the future: Primary care physicians (PCPs), principally family practitioners, on the top playing the lead role, distantly followed by specialists, with hospitals and other ancillary services even further down the line. Is this a reasonable expectation? Will PCPs dominate the new systems? Or will they be but one of many equally necessary components of these developing integrated health care delivery organizations? Looking at the various models now developing, it would seem that future integrated delivery systems will utilize both PCPs and specialists, but with strong augmentation from a diverse assortment of other health care professionals, including nonphysician providers, educators, and administrators. To separate the illusion of primary care dominance of the coming health care system from the likely reality, we should first determine what is driving the apparent present demand for primary care physicians. Next, we will examine the possible and probable reactions to that demand from an economic standpoint and from the points of view of both health care professionals and the public. Finally, we must try to picture how health care provider organizations of the future are likely to look and how they will integrate their health care professionals.     

Funding Strategies for Population Researchers: Perspectives from the National Institutes of Health

The purpose of this article is to briefly describe the application and funding process at the National Institutes of Health (NIH). We target our discussion to demographic and population science at the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), but the general strategies are applicable to social and behavioral scientists for all NIH funding opportunities.     

By all appearances: thoughts on colonialism,visuality and racial neoliberalism

ABSTRACT

In a Montreal neighbourhood in the fall of 2013, a community mural celebrating ‘diversity, adversity and solidarity’ was vandalized: the image of a Black woman was spray-painted white. In this paper, I take the events and discourses surrounding this incident and my personal responses to them as a starting point for examining the racialized politics of visual representation. Using critical race-class analysis informed by contemporary theories of Black visuality, I consider dynamics of Black invisibility and visibility in Canada and consider the role visual texts play in reinforcing, reproducing, and resisting racialized social relations. I argue for caution regarding politics of representation, and consider Black and Indigenous art practices for the creative forms of resistance to colonial-capitalist ideology and visual logics they offer.     

Bridging Rhetoric and Practice: New Perspectives on Barriers to Gendered Change

ABSTRACT

This article presents a new methodology, Gender Knowledge Contestation Analysis, and uses it to examine the processes under way when transformative gender equality policies, such as gender mainstreaming are implemented. Drawing on data gathered in the European Commission, the findings show the processes linking high-level rhetorical policy statements, strategic policies, and daily working practices. This analysis enables exploration of the mechanisms through which indifference to and nonawareness of gendered policy problems are collectively constituted and methods through which they can be challenged. Findings thus deepen our understanding of barriers to the implementation of gender mainstreaming and the steps required for its effective implementation.     

Maternal Lifetime Trauma Exposure,Prenatal Cortisol,and Infant Negative Affectivity

Little research has examined the impact of maternal lifetime trauma exposure on infant temperament. We examined associations between maternal trauma history and infant negative affectivity and modification by prenatal cortisol exposure in a sociodemographically diverse sample of mother–infant dyads. During pregnancy, mothers completed measures of lifetime trauma exposure and current stressors. Third‐trimester cortisol output was assessed from maternal hair. When infants were 6 months old, mothers completed the Infant Behavior Questionnaire‐Revised. In analyses that controlled for infant sex and maternal age, education, race/ethnicity, and stress during pregnancy, greater maternal trauma exposure was associated with increased infant distress to limitations and sadness. Higher and lower prenatal cortisol exposure modified the magnitude and direction of association between maternal trauma history and infant rate of recovery from arousal. The association between maternal trauma history and infant distress to limitations was somewhat stronger among infants exposed to higher levels of prenatal cortisol. The analyses suggested that maternal lifetime trauma exposure is associated with several domains of infant negative affectivity independently of maternal stress exposures during pregnancy and that some of these associations may be modified by prenatal cortisol exposure. The findings have implications for understanding the intergenerational impact of trauma exposure on child developmental outcomes.     

Addressing potential prior‐data conflict when using informative priors in proof‐of‐concept studies

Bayesian methods are increasingly used in proof‐of‐concept studies. An important benefit of these methods is the potential to use informative priors, thereby reducing sample size. This is particularly relevant for treatment arms where there is a substantial amount of historical information such as placebo and active comparators. One issue with using an informative prior is the possibility of a mismatch between the informative prior and the observed data, referred to as prior‐data conflict. We focus on two methods for dealing with this: a testing approach and a mixture prior approach. The testing approach assesses prior‐data conflict by comparing the observed data to the prior predictive distribution and resorting to a non‐informative prior if prior‐data conflict is declared. The mixture prior approach uses a prior with a precise and diffuse component. We assess these approaches for the normal case via simulation and show they have some attractive features as compared with the standard one‐component informative prior. For example, when the discrepancy between the prior and the data is sufficiently marked, and intuitively, one feels less certain about the results, both the testing and mixture approaches typically yield wider posterior‐credible intervals than when there is no discrepancy. In contrast, when there is no discrepancy, the results of these approaches are typically similar to the standard approach. Whilst for any specific study, the operating characteristics of any selected approach should be assessed and agreed at the design stage; we believe these two approaches are each worthy of consideration. Copyright © 2015 John Wiley & Sons, Ltd.