Public Voices in Pharmaceutical Deliberations: Negotiating “Clinical Benefit” in the FDA’s Avastin Hearing

This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA’s 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol’s (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe’s (2011) “hybrid forums,” we demonstrate that the FDA’s deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for “clinical benefit.” Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.     

Spectral Decompositions of Multiple Time Series: A Bayesian Non-parametric Approach

We consider spectral decompositions of multiple time series that arise in studies where the interest lies in assessing the influence of two or more factors. We write the spectral density of each time series as a sum of the spectral densities associated to the different levels of the factors. We then use Whittle’s approximation to the likelihood function and follow a Bayesian non-parametric approach to obtain posterior inference on the spectral densities based on Bernstein–Dirichlet prior distributions. The prior is strategically important as it carries identifiability conditions for the models and allows us to quantify our degree of confidence in such conditions. A Markov chain Monte Carlo (MCMC) algorithm for posterior inference within this class of frequency-domain models is presented. We illustrate the approach by analyzing simulated and real data via spectral one-way and two-way models. In particular, we present an analysis of functional magnetic resonance imaging (fMRI) brain responses measured in individuals who participated in a designed experiment to study pain perception in humans.     

STABILITY OF BIOLOGICAL FATHER PRESENCE AS A PROXY FOR FAMILY STABILITY: CROSS‐RACIAL ASSOCIATIONS WITH THE LONGITUDINAL DEVELOPMENT OF EMOTION REGULATION IN TODDLERHOOD

The current study, utilizing data from the National Early Head Start Research and Evaluation Project (Love et al., 2005) explored the relationship between biological father presence and emotion regulation over toddlerhood among children from low‐income families. Conceptualizing biological father presence as a proxy for family role development, results are interpreted from a role development theoretical perspective. The latent growth curve model was compared based on child ethnoracial status (African American, Caucasian, Hispanic) and child gender. Consistent biological father presence was associated with toddlers’ regulatory development across toddlerhood, and this relationship was most robust among Caucasian toddlers as compared to African American toddlers. Findings for Hispanic toddlers were not significantly different from those of Caucasian or African American families. Results bolster the literature on father presence and child outcomes. Analyses address consistency in father presence as a proxy for coherent role development and define a link between consistent father presence and children's regulatory development, demonstrating ethnoracial differences which are likely attributed to the social construction of family roles.     

Validation of the Spanish SIRS With Monolingual Hispanic Outpatients

Psychologists are faced with formidable challenges in making their assessment methods relevant to growing numbers of Hispanic clients for whom English is not the primary or preferred language. Among other clinical issues, the determination of malingering has profound consequences for clients. In this investigation, we evaluated a Spanish translation of the Structured Interview of Reported Symptoms (SIRS; Rogers, Bagby, & Dickens, 1992) with 80 Spanish-speaking Hispanic American outpatients. Using a between-subjects simulation design, the Spanish SIRS was found to produce reliable results with small standard errors of measurement. Regarding validity, very large effect sizes (mean Cohen’s d= 2.00) were observed between feigners and honest responders for the SIRS primary scales. We consider the potential role of the Spanish SIRS with reference to Spanish translations for other assessment instruments.     

Changing the criterion for memory conformity in free recall and recognition

People's responses during memory studies are affected by what other people say. This memory conformity effect has been shown in both free recall and recognition. Here we examine whether accurate, inaccurate, and suggested answers are affected similarly when the response criterion is varied. In the first study, participants saw four pictures of detailed scenes and then discussed the content of these scenes with another participant who saw the same scenes, but with a couple of details changed. Participants were either told to recall everything they could and not to worry about making mistakes (lenient), or only to recall items if they were sure that they were accurate (strict). The strict instructions reduced the amount of inaccurate information reported that the other person suggested, but also reduced the number of accurate details recalled. In the second study, participants were shown a large set of faces and then their memory recognition was tested with a confederate on these and fillers. Here also, the criterion manipulation shifted both accurate and inaccurate responses, and those suggested by the confederate. The results are largely consistent with a shift in response criterion affecting accurate, inaccurate, and suggested information. In addition we varied the level of secrecy in the participants’ responses. The effects of secrecy were complex and depended on the level of response criterion. Implications for interviewing eyewitnesses and line-ups are discussed.     

Quantum Biology and Psychology

Female college students (N = 112) completed a test battery of personality scales and performance tasks at home over four consecutive evenings, under one of eight combinations of the following experimental conditions: Schedule Source (experimenter versus self) × Scheduled Starting Time (strict versus lenient) × Plausibility of the Experiment. Delay in starting, summed over four evenings, constituted the measure of behavioral procrastination. This measure was moderately correlated with high test anxiety scores and low self-regulation. Procrastination was exacerbated when subjects were permitted to schedule the time of their expected completion of the test battery. Significant interactions of specific experimental conditions and specific personal traits demonstrated the situational requirements for trait-behavior relationships to emerge. Findings supported the internal consistency and construct validity of the behavioral procrastination measure. The practical and heuristic applications of a stimulus-organism-response (S-O-R) design and the theory-coordinated choice of experimental manipulation and corresponding organismic variable are recommended for future investigations of procrastination.     

In Pursuit of the MD: The Impact of Role Models, Identity Compatibility, and Belonging Among Undergraduate Women

Women continue to face gender-related challenges in the medical field in places around the world where it has traditionally been male-dominated, including in the U.S. In an online experimental study with women attending a mid-sized public university in the Northeastern U.S. (N?=?55) who were interested in pursuing a pre-medical track (being pre-med) as undergraduates, we explored the mechanisms involved in undergraduate women’s pursuit of a career as a physician, focusing on three factors: exposure to successful female physician role models, perceived identity compatibility between being a woman and being pre-med, and sense of belonging in pre-med. Participants were randomly assigned to an experimental condition in which they were exposed to information about successful female physicians, or to a control condition in which no information about female physicians was provided. First, as hypothesized, participants exposed to successful female physicians reported higher perceived identity compatibility, sense of belonging, and interest in a medical career compared to those in the control condition. Second, also as hypothesized, perceived identity compatibility mediated the effect of role models on sense of belonging, and sense of belonging mediated the relationship between perceived identity compatibility and interest in a medical career. This study highlights three key factors in women’s pursuit of a career as a physician and the process through which these factors may operate. Findings support the use of role models to set a positive psychosocial process in motion that can support women’s persistence in medicine.     

Spanish adaptation of the Psychological Well-Being Scales (PWBS)

The aim of this paper is to adapt to Spanish the D. van Direndonck version of Carol Ryff's Psychological Well-Being Scales, and to analyse its consistency and factorial validity. All the scales exhibited good internal reliabilities, with Cronbach alpha's ranging from 0.83 (Self-acceptance) to 0.68 (Personal growth). However, confirmatory factor analyses didn't corroborate the six-factor model (Self-acceptance, Positive relations, Autonomy, Environmental mastery, Purpose in life, and Personal growth) with a second order factor called Psychological Well-Being . To improve the psychometric properties, a new reduced version was proposed that indeed will facilitate the application. The scales of the new version maintain and raise its internal consistency (Cronbach alpha's 0.84 to 0.70). Furthermore, the scales shown an excellent fit to the theoretical model proposed by D. van Dierendonck.