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.     

Too Good to be False: An Essay in the Folklore of Social Science

In 1939, Carl Hovland and Robert R. Sears presented data that they believed linked fluctuations in the price of cotton to lynchings in the South, a linkage first suggested six years earlier by Arthur Raper. This correlation quickly became a popular illustration of frustration-aggression theory. A few years later, a statistical critique by Alexander Mintz cast the reality of the association into doubt, but a sample survey of members of the Society for the Psychological Study of Social Issues reveals that Howland and Sears's "finding" is still widely, if imprecisely, known and accepted. Their article continues to be cited in the social-psychological literature and in many introductory textbooks. The failure of Mintz's critique to catch up with the striking but flawed, original report illustrates a structured impediment to reliable knowledge in the social sciences.     

The role of social work in the ICU: reducing family distress and facilitating end-of-life decision-making

The costs associated with Intensive Care Units (ICUs) are high and at times invasive ICU care may not be beneficial, particularly for those patients admitted to ICUs who have little hope of recovery. The process of clarifying medical goals for these patients is often facilitated by addressing psychosocial factors. Social workers in the ICU are uniquely qualified to assess and address many of the complex psychosocial circumstances and can clarify potential misperceptions, enhancing communication among patients (if capacitated), their families, and the medical team members. This can not only help improve quality of life for very sick and dying patients in the ICU and their families, but may also reduce the likelihood of decision-making conflicts from arising. Further studies need to be done to investigate the effectiveness of social work interventions in reducing family distress, avoiding care that is unwanted by patients, and demonstrating cost-saving benefits.     

Mindfulness in financial literacy

ABSTRACT

Financial education is becoming imperative in a society that has pitfalls for unwary consumers. To ensure effectiveness, educational strategies must take into consideration the readiness of consumers to learn the curriculum. Behavioral economics highlights the obstacles that educators face in promoting financial efficacy. Such obstacles include envy, fear, greed, and other all too familiar human failings. One innovative model, mindfulness, provides insight into the human dynamics of personal financial behaviors. This article ties together financial education, mindfulness techniques, and transtheoretical stages of readiness. The impact of gradually introduced educational tasks is presented with an eye toward clients’ stages of readiness, and mindfulness addresses the emotional burdens of altering a financially profligate lifestyle.     

After the Storm: How Race,Class, and Immigration Concerns Influenced Beliefs About the Katrina Evacuees*

Objective. In September 2005, approximately 150,000 Gulf Coast residents fled to Houston, Texas, seeking shelter following Hurricane Katrina. Since the majority of evacuees were poor African Americans, the political and social consequences of the storm inspired a national dialogue on race and class. However, in Houston, the discourse on Katrina evacuees also involved immigration concerns. The city's distinction as a gateway to new arrivals influenced the dialogue on the evacuees' impact on the local area. This article assesses the extent to which race, class, and immigration concerns influenced Houstonians' beliefs about the Katrina evacuees. Methods. We analyze data from the 2006 and 2008 Houston Area Survey in order to assess attitudes toward these newcomers at two distinct time periods: within six months of their arrival and then again more than two years later. Results. Our findings show that both national and local factors influenced beliefs about the Katrina evacuees. Conclusions. The dynamics of race/ethnicity and apprehension toward immigrants drove largely antagonistic beliefs about the mostly poor, mostly black new arrivals.     

Brief Report: Thin Slices of Racial Bias

The present work examined the detection of racial bias through thin slices of nonverbal behavior. Thirty Black and 30 White American judges rated the nonverbal behavior displayed by White individuals from 20-seconds of silent videotape of an interaction with either a Black or a White confederate. Correlations between judges nonverbal ratings and targets scores on a response latency measure of racial bias (i.e., Implicit Association Test, IAT) as well as on a self-report racial bias measure (i.e., Affective Prejudice Scale) were obtained. Results revealed that relative to White judges, Black judges nonverbal behavioral ratings were better predictors of both White individuals IAT and explicit racial bias scores, but only if those targets were engaged in an interracial dyad. The results are consistent with recent research finding that subtle forms of racial bias leak through nonverbal behavior, as well as with work noting the predictive accuracy of judgments made from thin-slices of nonverbal behavior.Jennifer A. Richeson and J. Nicole Shelton. Jennifer A. Richeson, Dartmouth College; J. Nicole Shelton, Princeton University. This research was supported by a Rockefeller Center Faculty Fellowship from Dartmouth College awarded to JR, as well as a research grant from Princeton University awarded to JNS. We thank Sue Paik, Lisa Pugh, Kurt Peters, and Leigh Poretzky for help with data collection and stimulus preparation.     

Empirically based conversion factors for calculating couple-years of protection

Couple-years of protection (CYP) is one of several commonly used indicators to assess international family planning efforts. It has been the subject of much debate, relating in part to the specific conversion factors used to translate the quantity of the respective contraceptive methods distributed to a single measure of protection. This article outlines a comprehensive effort to revisit those conversion factors based on the best available empirical evidence. In most instances, the analysis supports previously established standard conversion factors. However, there are two notable departures. Fewer condoms and spermicides are recommended for each CYP (120 vs. 150), primarily because coital frequency among condom users is lower than previously assumed. Furthermore, for sterilization, the authors recommend the use of country or region-specific conversion factors. Every program evaluation indicator has strengths and weaknesses, and the best program evaluation efforts use a variety of indicators. If CYP is used to evaluate programs, however, the authors believe that the conversion factors presented reflect the best available evidence.