Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Empathy and theory of mind in deaf and hearing children

Empathy (or sharing another’s emotion) and theory of mind (ToM: the understanding that behavior is guided by true and false beliefs) are cornerstones of human social life and relationships. In contrast to ToM, there has been little study of empathy’s development, especially in deaf children. Two studies of a total of 117 children (52 hearing; 65 deaf children of hearing parents) aged 4–13 years were therefore designed to (a) compare levels of empathy in deaf and hearing children, and (b) explore correlations of ToM with empathy in deaf and hearing groups. Results showed that (a) deaf children scored lower in empathy than their hearing peers and (b) empathy and ToM were significantly correlated for deaf children but not for the hearing. Possible reasons for these divergent developmental patterns were considered, along with implications for future research

The ticking of the social clock: Adults' beliefs about the timing of transition events

In two studies, beliefs about descriptive and prescriptive age norms for adult developmental transitions were examined in a sample of 214 Australian university students aged seventeen to fifty years. The results of Study 1 revealed a belief by the vast majority that descriptive age norms still exist for both family transitions (marriage, parenthood, grandparenthood) and career transitions (leaving school, retirement). While these results were in keeping with those of Neugarten et al.'s [1] original study of age norms in the United States, the actual 'best' normative ages recommended by this sample of contemporary Australian adults differed in every case from the U.S. age norms [1] of three decades ago. Matching contemporary demographic trends, the present Australian young-adult sample advocated later ages for marriage and grandparenthood, a younger norm for leaving school, and a broader normative age range for retiring from work. Study 2 tested Neugarten's hypothesis that age norms today lack some of the prescriptive overtones implicit in original 'social clock' concept [2]. The results supported this suggestion. In fact, only a minority of contemporary Australian adults believed that there were prescriptive upper age boundaries for first marriage or university study. Furthermore, their prescriptive lower age limits for every transition except retirement fell at or below the onset of adulthood itself (18 years), in keeping with biological constraints on procreation and maturational constraints on social and cognitive development. The mean ranges of acceptability prescribed by this Australian sample for each key adult transition were likewise very wide, stretching from an average of twenty- four years (for motherhood) to forty-nine years (for a man's first marriage). This result also contrasts sharply with the ranges of no more than five years prescribed for the same transitions by the vast majority of Neugarten et al.'s sample three decade ago [1]. The probable consequences for self- esteem, mental health and life planning of this heightened variability and reduced prescriptiveness in the timing of life events for contemporary men and women were discussed

Husbands' and wives' perceptions of marital fairness across the family life cycle

Equity theory presents a model of couplehood in which husbands and wives negotiate over time and through the domestic upheavals brought about by childbirth, offsprings’ adolescence, the empty nest crisis, and so on, to achieve the subjectively fair balance between each spouse’s contributions and benefits known as marital equity. The latter is the pattern that has typically emerged in the numerous studies that have assessed husbands’ and wives’ marital satisfaction in relation to the family life cycle. Numbers of women in the childbearing and launching subdivisions of the present sample were too small to justify separate analyses by family size. Perhaps the most striking similarity is the parallel between the U-shaped pattern of the present sample of husbands’ perceptions of their marital equity over family life stages and a similarly U-shaped course of marital happiness from the newly wed period to empty nest

Factors predicting safe-sex talk and condom use in early sexual relationships

This study explored some of the antecedents and consequences of young adults' beliefs about safe-sex communication in their early couple relationships. The sample consisted of 237 unmarried, heterosexual Australian university students, 16 to 19 years of age, approximately evenly divided between virgins and those with sexual experience. Drawing on a model of couple sexual communication as the product of prior experiences with communication, assertion, and conflict resolution in the family of origin, we examined links between these variables and respondents' attitudes and practices of safe-sex discussion and condom use with their dating partners. The results showed that women and nonvirgin men had more positive attitudes toward safe-sex communication than male virgins had. Difficulties with self-assertion outside of the sexual context and mothers' and fathers' use of avoidance as a conflict resolution strategy were negatively correlated with willingness to discuss safe sex, whereas mothers' more frequent safe-sex education was a positive predictor. The results of a hierarchical multiple regression analysis indicated that assertion, paternal conflict avoidance, and male gender were independent predictors of reluctance to negotiate for safer sex. At abehavioral level, positive attitudes to safe-sex discussion predicted having talked about AIDS and condoms with a dating partner as well as actual condom use by the subsample of daters who had experienced sexual intercourse. Implications for improving family and couple communication and for sex education were considered

How conversational input shapes theory of mind development in infancy and early childhood

Human social cognition is largely driven by the theory of mind (ToM), that is, our ability to think about others in terms of the mental states (feeling, wanting, knowing, etc.) that underlie their behaviour. The effects of language on ToM can be seen in terms of children's exposure to conversations with parents and other partners - conversations that appear to be crucial to children's acquisition of mental state concepts and theory of mind vocabulary. But mental states are notoriously slippery concepts - they are subjective, abstract, and invisible. This chapter reviews correlational and training studies on the link between parents' mental state talk and young children's ability to pass ToM tasks. It reports work that highlights the extent to which some mothers, in particular, tailor their conversation to match and promote their children's knowledge in this domain. It shows that the richness of mothers' talk about mental states during the preschool years is linked to their children's emerging ToM. Specifically, mothers who regularly explain thought processes and how these cause behaviour often have children who are particularly advanced in their responses on stories designed to test ToM. The chapter proposes a clarifying analogy between the 'motherese' qualities language used by mothers in facilitating children's language development and mothers' mental state talk as a facilitating factor in acquiring mental state concepts and promoting reasoning about the causal links between mental states and people's actions

Scaling theory of mind development in Indigenous- and Anglo-Australian toddlers and older children

We examined the growth of a theory of mind (ToM) in Indigenous Australian children who spoke Aboriginal English as their first language. We also pioneered the suitability of a five-step developmental scale of ToM understanding for 2-year-old toddlers from Indigenous- and Anglo-Australian cultural backgrounds. A total of 97 children aged 2 to 5 years took (a) a battery of false belief (FB) tests, (b) a developmental ToM Scale, and (c) a standard language ability test. Results showed that, contrary to earlier findings for Piagetian tasks, the Indigenous Australian children were not delayed in ToM understanding. Instead, at age 2, Indigenous toddlers significantly outperformed their Anglo peers and throughout the preschool years they scored just as highly on FB and all ToM Scale steps as Anglo-Australians their age, notwithstanding their statistically significant delays behind Anglo-Australians in standard English language skill (the language of testing). We also found, for the first time, that the five-step ToM Scale was both suitable for, and sensitive to individual differences in, children as young as age 2. These findings add to a growing body of research highlighting the importance of early family and cultural experiences for the growth of social cognition