Response‐adaptive designs for binary responses: How to offer patient benefit while being robust to time trends?

Response‐adaptive randomisation (RAR) can considerably improve the chances of a successful treatment outcome for patients in a clinical trial by skewing the allocation probability towards better performing treatments as data accumulates. There is considerable interest in using RAR designs in drug development for rare diseases, where traditional designs are not either feasible or ethically questionable. In this paper, we discuss and address a major criticism levelled at RAR: namely, type I error inflation due to an unknown time trend over the course of the trial. The most common cause of this phenomenon is changes in the characteristics of recruited patients—referred to as patient drift. This is a realistic concern for clinical trials in rare diseases due to their lengthly accrual rate. We compute the type I error inflation as a function of the time trend magnitude to determine in which contexts the problem is most exacerbated. We then assess the ability of different correction methods to preserve type I error in these contexts and their performance in terms of other operating characteristics, including patient benefit and power. We make recommendations as to which correction methods are most suitable in the rare disease context for several RAR rules, differentiating between the 2‐armed and the multi‐armed case. We further propose a RAR design for multi‐armed clinical trials, which is computationally efficient and robust to several time trends considered.     

Discussion of “Nonparametric Bayesian Inference in Applications”: Bayesian nonparametric methods in econometrics

The use of Bayesian nonparametrics models has increased rapidly over the last few decades driven by increasing computational power and the development of efficient Markov chain Monte Carlo algorithms. We review some applications of these models in economic applications including: volatility modelling (using both stochastic volatility models and GARCH-type models) with Dirichlet process mixture models, uses in portfolio allocation problems, long memory models with flexible forms of time-dependence, flexible extension of the dynamic Nelson-Siegel model for interest rate yields and multivariate time series models used in macroeconometrics.     

Special issue on “The role of intellectual capital and integrated reporting in management and governance: a performative perspective”

Journal of Management and Governance -     

External Information Model in a Compositional Perspective: Evaluation of Campania Adolescents’ Preferences in the Allocation of Leisure-Time

Social Indicators Research - The study of preferences of leisure-time activities provides important information on the characteristics and inclinations of specific demographics. Modeling these data...     

Activity patterns and temporal niche partitioning of dogs and medium-sized wild mammals in urban parks of Xalapa,Mexico

Urban Ecosystems - Free-ranging domestic dogs are the world most common exotic carnivore species that could negatively interact with the native wildlife as predators, competitors, and disease...     

20 years of Bologna - a story of success,a story of failure

The Bologna Process is a unique harmonisation process taking place outside the policy-making framework of the European Union. It aims at enhancing the comparability and compatibility of higher education structures and degrees across Europe, as well as to institutionalise quality assurance mechanisms. The aim of this article is to provide a condensed, up-to-date overview of the Bologna Process with regard to structural characteristics, before embedding it into a discussion on processes on voluntary policy convergence and to which extent we should be able to find this kind of policy harmonisation in the realm of the Bologna Process. Related to this are questions why this, in principle, completely voluntary process of policy harmonisation, has appealed to so many countries and why they might or might not feel committed to the implementation of its policies and tools.     

Sexual Beliefs and Sexual Functioning: The Mediating Role of Cognitive Distraction

Dysfunctional sexual beliefs are vulnerability factors for sexual dysfunction. This cross-sectional study aimed to test the mediating role of cognitive distraction on the relationship between dysfunctional sexual beliefs about sexual functioning shared by men and women and sexual function. The authors used a sample of 421 cisgender heterosexual participants involved in a monogamous relationship. The hypothesized mediation model was tested using a bootstrapped cross product of coefficients approach. Results showed a significant negative, indirect effect between dysfunctional sexual beliefs and women's sexual function through cognitive distraction. The discussion of this study highlights the importance of cognitive factors in sexual functioning.