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.     

School-based prevention of bullying and relational aggression in adolescence: the fairplayer.manual

The fairplayer.manual is a school-based program to prevent bullying. The program consists of fifteen to seventeen consecutive ninety-minute lessons using cognitive-behavioral methods, methods targeting group norms and group dynamics, and discussions on moral dilemmas. Following a two-day training session, teachers, together with skilled fairplayer.teamers, implement fairplayer.manual in the classroom during regular school lessons. This chapter offers a summary of the program's conception and underlying prevention theory and summarizes the results from two evaluation studies. Standardized questionnaires showed a positive impact of the intervention program on several outcome variables.     

Asperger’s Syndrome and the Decoding of Boredom,Interest, and Disagreement from Body Posture

Twenty Asperger’s Syndrome (AS) participants were compared with 20 matched neurotypical controls in their decoding of postural cues of boredom, interest, and disagreement. On a nonverbal matching task, the AS group performed as accurately as the controls, whereas on a verbal labeling task, AS participants made significantly more mistakes in labeling bored postures. Response times of the AS group were significantly slower than controls in their judgments of all three attitudes on both tasks, with the exception only of disagreeing postures on the verbal labeling task. It was hypothesized that these slower response times may reflect a feature-based cognitive processing style by AS participants. Proposed practical recommendations are to train AS individuals in the recognition of boredom, and to improve the speed with which they can recognize different attitudes.     

Essay-Comment: On the Final Report of the Royal Commission on Human Relationships—Australian Government Publishing Service,Canberra, 1977.

“Strange thing—human relationships—for a Government to set up a Royal Commission on.” That is a comment I have heard more than once. It has been accompanied by an aloofness, a slight irritability, keeping the Report at arm's length and unread. That is from one section of the public. There are many other reactions. And there are our colleagues, many of whom have said how very important the Report is, and they have read it. Midway between these and other polarized viewpoints stands the Report itself, a long important essay in societal self-awareness. No wonder it has aroused much contradictory response.     

Secularization and medicalization

This paper examines Bryan Turner's view that medicine has replaced religion as the 'social guardian of morality.' It argues that Turner's failure to co-ordinate the theories of secularization and medicalization has prevented this hypothesis from being fully explored. A systematic and synthesized account of both medicalization and secularization is given, and used as the framework for a review of the history of Seventh-day Adventism-a sect that is both a product and an agent of the two processes. In conclusion it is suggested that medicalization may be conductive to sect development, and that secularization and medicalization are compatible models of social change.     

Two-step jackknife bias reduction for logistic regression mles

Maximum likelihood estimates (MLEs) for logistic regression coefficients are known to be biased in finite samples and consequently may produce misleading inferences. Bias adjusted estimates can be calculated using the first-order asymptotic bias derived from a Taylor series expansion of the log likelihood. Jackknifing can also be used to obtain bias corrected estimates, but the approach is computationally intensive, requiring an additional series of iterations (steps) for each observation in the dataset.Although the one-step jackknife has been shown to be useful in logistic regression diagnostics and i the estimation of classification error rates, it does not effectively reduce bias. The two-step jackknife, however, can reduce computation in moderate-sized samples, provide estimates of dispersion and classification error, and appears to be effective in bias reduction. Another alternative, a two-step closed-form approximation, is found to be similar to the Taylo series method in certain circumstances. Monte Carlo simulations indicate that all the procedures, but particularly the multi-step jackknife, may tend to over-correct in very small samples. Comparison of the various bias correction proceduresin an example from the medical literature illustrates that bias correction can have a considerable impact on inference