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As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved. [ABSTRACT FROM AUTHOR]

The Pennsylvania Longitudinal Study of Parents and Children Twin Registry was developed to capture a representative sample of multiple births and their parents in the state of Pennsylvania. The registry has two main efforts. The first began in 2012 through recruitment of adolescents in Pennsylvania schools. The second effort began in January 2019 in partnership with the Pennsylvania Department of Health to capture the birth cohort of twins born from 2007 to 2017. Study recruitment, sample demographics, focus and measures are provided, as well as future directions. [ABSTRACT FROM AUTHOR]

Objective: The present study explored chronic disease management over the monthly benefit cycle among primary food shoppers from households receiving Supplemental Nutrition Assistance Program (SNAP) benefits in Philadelphia, PA, USA.Design: In-depth interviews, participant observation and surveys were conducted with the primary food shopper of SNAP households.Setting: Interviews and surveys were conducted in a clinical setting at Children's Hospital of Philadelphia, at participants' homes, and in food procurement settings including grocery stores, food pantries and soup kitchens.Participants: Eighteen adults who received SNAP; five with a diet-related chronic condition, five managing the chronic condition of a family member and thirteen with overweight or obesity.Results: All households had at least one member with a chronic disease or condition. Households reported that the dietary demands of managing chronic illnesses were expensive and mentally taxing. Food and financial shortfalls at the end of the benefit cycle, as well as reliance on charitable food assistance programmes, often had negative impacts on chronic disease self-management.Conclusions: Drawing from nearly 50 h of in-depth qualitative interviews with SNAP participants, the study highlights the dual cognitive burden of poverty and chronic disease and elucidates the particular challenges of food procurement and maintenance of diet quality throughout the benefit month faced by SNAP households with diet-related chronic diseases. Interventions targeted at reducing the cost of medically appropriate, healthy foods may help to improve chronic disease self-management within SNAP populations. [ABSTRACT FROM AUTHOR]

Objective: Philadelphia passed a 1·5-cent-per-ounce sweetened beverage tax (SBT). Revenue will fund 10 000 quality pre-kindergarten slots for poor children. It is imperative to understand how revenue from SBT can be used to fund programmes to address education and other social determinants of health. The objective of the present study was to simulate quality pre-kindergarten attendance, educational achievement and sugar-sweetened beverage (SSB) consumption among Philadelphia children and adolescents under six intervention scenarios: (i) no intervention; (ii) 10 000 additional quality pre-kindergarten slots; (iii) a 1·5-cent-per-ounce SBT; (iv) expanded pre-kindergarten and 1·5-cent-per-ounce SBT; (v) a 3-cent-per-ounce SBT; and (vi) expanded pre-kindergarten and 3-cent-per-ounce SBT.Design: We used an agent-based model to estimate pre-kindergarten enrolment, educational achievement and SSB consumption under the six policy scenarios. We identified key parameters in the model from the published literature and secondary analyses of the Panel Study of Income Dynamics - Child Development Supplement.Setting: Philadelphia, Pennsylvania, USA.Subjects: Philadelphia children and adolescents aged 4-18 years.Results: A 1·5-cents-per-ounce tax would reduce SSB consumption by 1·3 drinks/week among Philadelphia children and adolescents relative to no intervention, with larger effects among children below the poverty level. Quality pre-kindergarten expansion magnifies the effect of the SBT by 8 %, but has the largest effect on moderate-income children just above the poverty level. The SBT and quality pre-kindergarten programme each reduce SSB consumption, but primarily benefit different children and adolescents.Conclusions: Pairing an excise tax with a complementary programme to improve a social determinant of health represents a progressive strategy to combat obesity, a disease regressive in its social patterning. [ABSTRACT FROM AUTHOR]

BackgroundStress and vulnerability likely interact to play a major role in psychosis. While much has been written about the neural diathesis-stress model in psychosis and its clinical risk states, little is known about HPA axis biomarkers in non-help-seeking individuals at familial high risk (FHR). We sought to prospectively measure pituitary volume (PV) in adolescents and young adults at FHR for schizophrenia and to follow their emerging sub-clinical psychotic symptoms and clinical trajectories.MethodForty healthy controls and 38 relatives of patients with schizophrenia or schizoaffective disorder were identified in Pittsburgh, USA. PV was derived from baseline 1.5 T magnetic resonance imaging. Chapman's schizotypy scales were acquired at baseline, and structured clinical interviews for DSM-IV-TR Axis I diagnoses were attempted annually for up to 3 years.ResultsSeven individuals converted to psychosis. PV did not differ between FHR and control groups overall. Within the FHR group, PV was positively correlated with Chapman's positive schizotypy (Magical Ideation and Perceptual Aberration) scores, and there was a significant group × PV interaction with schizotypy. PV was significantly higher in FHR subjects carrying any baseline Axis I diagnosis (p = 0.004), and higher still in individuals who went on to convert to psychosis (p = 0.0007).ConclusionsIncreased PV is a correlate of early positive schizotypy, and may predict trait vulnerability to subsequent psychosis in FHR relatives. These preliminary findings support a model of stress-vulnerability and HPA axis activation in the early phases of psychosis. [ABSTRACT FROM AUTHOR]