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.     

Assessment of Distraction From Erotic Stimuli by Nonerotic Interference

Distraction from erotic cues during sexual encounters is a major contributor to sexual difficulties in men and women. Being able to assess distraction in studies of sexual arousal will help clarify underlying contributions to sexual problems. The current study aimed to identify the most accurate assessment of distraction from erotic cues in healthy men (n = 29) and women (n = 38). Participants were assigned to a no distraction, low distraction, or high distraction condition. Distraction was induced using an auditory distraction task presented during the viewing of an erotic video. Attention to erotic cues was assessed using three methods: a written quiz, a visual quiz, and a self-reported distraction measure. Genital and psychological sexual responses were also measured. Self-reported distraction and written quiz scores most accurately represented the level of distraction present, while self-reported distraction also corresponded with a decrease in genital arousal. Findings support the usefulness of self-report measures in conjunction with a brief quiz on the erotic material as the most accurate and sensitive ways to simply measure experimentally-induced distraction. Insight into distraction assessment techniques will enable evaluation of naturally occurring distraction in patients suffering from sexual problems.     

When Working Hard Is Not Enough for Female and Racial/Ethnic Minority Apprentices in the Highway Trades

Drawing on employment records, qualitative interviews, and a survey, we explore the experiences of apprentices in the highway trades in Oregon. We demonstrate that female and racial/ethnic minority apprentices have lower rates of recruitment and retention and disproportionately face challenges with interpersonal interactions, hiring practices, and supervisory practices. Yet, we find a pervasive narrative that attributes apprentices' success to “hard work,” which contributes to the legitimacy of these inequalities. Consistent with the conceptualization of work organizations as inequality regimes, we argue that the apprenticeship system has policies, practices, and ideologies that are on the surface gender and race/ethnicity neutral, yet lead to the perpetuation of inequalities.     

Young people,social media and connective action: from organisational maintenance to everyday political talk

Social media is pervasive in the lives of young people, and this paper critically analyses how politically engaged young people integrate social media use into their existing organisations and political communications. This qualitative research project studied how young people from a broad range of existing political and civic groups use social media for sharing information, mobilisation and, increasingly, as a means to redefine political action and political spaces. Twelve in-person focus groups were conducted in Australia, the USA and the UK with matched affinity groups based on university campuses. The groups were of four types: party political group, issue-based group, identity-based group and social group. Our focus group findings suggest that this in-depth approach to understanding young people's political engagement reveals important group-based differences emerging in young people's citizenship norms: between the dutiful allegiance to formal politics and a more personalised, self-actualising preference for online, discursive forms of political engagement and organising. The ways in which political information is broadcast, shared and talked about on social media by engaged young people demonstrate the importance of communicative forms of action for the future of political engagement and connective action.     

What is Flint? Place,storytelling, and social media narrative reclamation during the Flint water crisis

ABSTRACT

The Flint Water Crisis became a national news story in January of 2016, when major publishers such as The New York Times began covering the story. In the same month, an influx of social media activism occurred in response to the crisis, with citizens developing hashtag campaigns such as #FlintFwd in order to disseminate news and stories from a citizen’s perspective; these campaigns often positioned Flint positively ? as a recovering community ? rather than a city in the middle of a public health crisis, and often addressed not a national public but a local audience. This paper considers Flint-based social media activity to investigate the emergence of place-based activism within the ostensibly global network of social media. In doing so, it identifies three key themes; 1) leveraging social media to forward a critique of deficient journalistic storytelling; 2) using the affective process of storytelling via social media to claim authority over their own material offline existence, and 3) using place-based storytelling to implicate others as witnesses via the global network of social media. These themes coalesce around a distinctly critical logic of connectivity. This logic extends the notion of connectivity articulated by Van Dijck and Poell [2013. Understanding social media logic. Media and Communication, 1(1), 2–14.] and the strategies of platform activism explored by Tufekci [2017. Twitter and tear gas: The power and fragility of networked protest. New Haven: Yale University Press.] to explain how social media works to expose discrepancies between the public story of the water crisis and material, lived conditions of Flint, rendering visible a discursive identity of Flint thus far unrecognized.     

A new generalized Weibull distribution in income economic inequality curves

Researchers have been developing various extensions and modified forms of the Weibull distribution to enhance its capability for modeling and fitting different data sets. In this note, we investigate the potential usefulness of the new modification to the standard Weibull distribution called odd Weibull distribution in income economic inequality studies. Some mathematical and statistical properties of this model are proposed. We obtain explicit expressions for the first incomplete moment, quantile function, Lorenz and Zenga curves and related inequality indices. In addition to the well-known stochastic order based on Lorenz curve, the stochastic order based on Zenga curve is considered. Since the new generalized Weibull distribution seems to be suitable to model wealth, financial, actuarial and especially income distributions, these findings are fundamental in the understanding of how parameter values are related to inequality. Also, the estimation of parameters by maximum likelihood and moment methods is discussed. Finally, this distribution has been fitted to United States and Austrian income data sets and has been found to fit remarkably well in compare with the other widely used income models.     

Behavioral responses of rural and urban greater white-toothed shrews (Crocidura russula) to sound disturbance

Urban Ecosystems - The development of urban areas imposes challenges that wildlife must adapt to in order to persist in these new habitats. One of the greatest changes brought by urbanization has...     

Inference and Decision Making for 21st-Century Drug Development and Approval

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.     

What is educational entrepreneurship? Strategic action,temporality, and the expansion of US higher education

Theory and Society - The massive expansion of US higher education after World War II is a sociological puzzle: a spectacular feat of state capacity-building in a highly federated polity. Prior...