Heterogeneity in treatment effects across diverse populations

Differences in patient characteristics, including age, sex, and race influence the safety and effectiveness of drugs, biologic products, and medical devices. Here we provide a summary of the topics discussed during the opening panel at the 2018 Johns Hopkins Center for Excellence in Regulatory Science and Innovation symposium on Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities. The goal of this session was to provide a brief overview of FDA-regulated therapeutics, including drugs, biologics and medical devices, and some of the major sources of heterogeneity of treatment effects (HTE) related to patient demographics, such as age, sex and race. The panel discussed the US Food and Drug Administration's role in reviewing and regulating drugs, devices, and biologic products and the challenges associated with ensuring that diverse patient populations benefit from these therapeutics. Ultimately, ensuring diverse demographic inclusion in clinical trials, and designing basic and clinical research studies to account for the intended patient population's age, sex, race, and genetic factors among other characteristics, will lead to better, safer therapies for diverse patient populations.     

Latent Profiles of Discrimination and Socialization Predicting Ethnic Identity and Well‐Being Among Asian American Adolescents

Ethnic identity is rooted in sociocultural processes, but little is known about how social interactions predict its longitudinal changes. Using data from 154 Asian American adolescents, latent profile analysis derived four typologies based on unfair treatment (i.e., discrimination, model minority stereotyping) and ethnic socialization (i.e., cultural socialization, preparation for bias, promotion of mistrust): Low Cultural Salience, High Cultural Salience with Marginalization, Culturally Prepared with Low Mistrust, and High Mistrust/Discrimination. Few gender or generational differences in profile membership were found. Positive outcomes were linked to adolescents attuned to both positive and negative experiences, Culturally Prepared with Low Mistrust, who reported increases in ethnic belonging and decreases in negative emotions. The implications for identity formation and adjustment are discussed.     

Meningococcal serogroup B outbreak response University of Wisconsin-Madison

A meningococcal serogroup B (MenB) outbreak at a large public university prompted an emergency response to immunize undergraduates. Objective: To report on a successful meningococcal serogroup B (MenB) vaccine clinic response at a large public university. Methods: We assembled the team leaders to write this case report. Results: Activation of the emergency plan and points of dispensing required cooperation of many units on campus under the leadership of university health officials with support from Centers for Disease Control and Prevention, state division of public health and the city-county health department. Significant efforts to provide consistent messages to students and parents regarding the outbreak and the availability of the MenB vaccines were made. Volunteers were recruited to staff the clinics alongside university healthcare providers. Over 22,000 doses of vaccine were administered. Conclusion: We report our experience and lessons learned which may be helpful to universities in preventing and responding to disease outbreaks.     

The exponential distribution analog of the Grubbs–Weaver method

Abstract

Grubbs and Weaver (1947 Grubbs, F. E., and C. L. Weaver. 1947. The best unbiased estimate of population standard deviation based on group ranges. Journal of the American Statistical Association 42 (238):224–41. doi: 10.2307/2280652.[Taylor & Francis Online], [Web of Science ®] , [Google Scholar]) suggest a minimum-variance unbiased estimator for the population standard deviation of a normal random variable, where a random sample is drawn and a weighted sum of the ranges of subsamples is calculated. The optimal choice involves using as many subsamples of size eight as possible. They verified their results numerically for samples of size up to 100, and conjectured that their “rule of eights” is valid for all sample sizes. Here we examine the analogous problem where the underlying distribution is exponential and find that a “rule of fours” yields optimality and prove the result rigorously.     

A figurational approach to understanding school climate and peer harassment: Possibilities from Norbert Elias’s work

Although psychological approaches have been the mainstay of scholarly research on school climate, offering state-of-the-art measurements and methodologies, sociological perspectives remain essential perspectives because violence is essentially a social phenomenon. This paper offers a theoretical consideration of contributions to this field, focusing specifically on those that provide a critical historical lens. I suggest that while Foucault's approach to the disciplining of docile bodies and self-restraint offers crucial conceptual tools, Norbert Elias's work—which is scarce in scholarly research on school climate—provides a complementary but necessary framework for understanding emotional and relational aspects of peer harassment.     

Digital Strategies for Building Spiritual Intimacy: Families on a “Wired” Camino

Qualitative Sociology - Researchers have explored the role that information and communication technologies (ICTs) play in mediating both religious practice and intergenerational family...     

Happy People Have Children: Choice and Self-Selection into Parenthood

There is mixed evidence in the existing literature on whether children are associated with greater subjective well-being, with the correlation depending on which countries and populations are considered. We here provide a systematic analysis of this question based on three different datasets: two cross-national and one national panel. We show that the association between children and subjective well-being is positive only in developed countries, and for those who become parents after the age of 30 and who have higher income. We also provide evidence of a positive selection into parenthood, whereby happier individuals are more likely to have children.     

Food in Foster Families: Care,Communication and Conflict

This study explores the significance of food and mealtimes in relation to the transition into foster care and the therapeutic settling of the child in a new family. In doing so, we draw upon an in‐depth, qualitative case study of 10 experienced foster families in the UK focusing on what helped them to be successful. At the time of the study, there were 16 foster children, aged 9–16, living with the families. Data collection included semi‐structured qualitative interviews and audio‐diaries with all family members who wished to be involved as well as eco‐maps produced by the young people. Thematic analysis and data extracts are reproduced in the study to demonstrate that meals and food preferences can function to affirm identities, membership and boundaries of family life as well as provide a site of conflict and control.