Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation

Children represent a large underserved population of “therapeutic orphans,” as an estimated 80% of children are treated off‐label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that is, the leveraging of available data from adults or older age groups to draw conclusions for the pediatric population. The Bayesian statistical paradigm is natural in this setting, as it permits the combining (or “borrowing”) of information across disparate sources, such as the adult and pediatric data. In this paper, authored by the pediatric subteam of the Drug Information Association Bayesian Scientific Working Group and Adaptive Design Working Group, we develop, illustrate, and provide suggestions on Bayesian statistical methods that could be used to design improved pediatric development programs that use all available information in the most efficient manner. A variety of relevant Bayesian approaches are described, several of which are illustrated through 2 case studies: extrapolating adult efficacy data to expand the labeling for Remicade to include pediatric ulcerative colitis and extrapolating adult exposure‐response information for antiepileptic drugs to pediatrics.     

Revisiting the Association between Pornography Use and Risky Sexual Behaviors: The Role of Early Exposure to Pornography and Sexual Sensation Seeking

Among the suggested problems and harms associated with widespread pornography use among young people, risky sexual behaviors have been frequently mentioned. To further explore this public health concern, this article analyzed sexual sensation seeking (SSS) as a potential confounder of the association between pornography use and sexual risks using data collected in 2010 from a population-based sample of young Croatian adults aged 18 to 25 (n = 1,005). Significant, but small, correlations were found between the indicators of pornography use (age at first exposure, frequency of use in the past 12 months, and personal importance of pornography) and sexual risk taking. However, in a multivariate analysis, only age at first exposure to pornography remained a significant, albeit weak, predictor of sexual risk taking among both women and men. SSS, defined as the dispositional tendency toward the impulsive pursuit of sexual arousal and stimulation, neither confounded nor moderated this association. Overall, the findings do not support the notion that pornography use is substantially associated with sexual risk taking among young adults, but suggest that early exposure to sexually explicit material and high SSS are additive risk factors for sexual risk taking.     

Outcomes of specialized foster care in a managed child welfare services network

This study (N = 384) presents results from outcome measurement in a services network providing specialized foster care (SFC) to children in child protective service custody. A majority of participants improved on most outcomes. Global improvement was associated with increased length of stay up to two years, five months, and with younger age, fewer problems, and, paradoxically, the presence of a trauma history. Results suggest the value of SFC within managed services and of research using outcome measurement systems.     

Evaluating a multiple-family group access intervention for refugees with PTSD

The purpose of this study was to analyze the effects of a multiple-family group in increasing access to mental health services for refugees with posttraumatic stress disorder (PTSD). This study investigated a nine-session multiple-family group called Coffee and Families Education and Support with refugee families from Bosnia-Herzegovina in Chicago. Adults with PTSD (n = 197) and their families were randomly assigned to receive either the intervention or a control condition. The results indicated that a multiple-family group was effective in increasing access to mental health services and that depression and family comfort with discussing trauma mediated the intervention effect. Further well-designed studies of family interventions are needed for developing evidence-based interventions for refugee families.