Leveraging systems science and design thinking to advance implementation science: moving toward a solution-oriented paradigm.

Many public health challenges are characterized by complexity that reflects the dynamic systems in which they occur. Such systems involve multiple interdependent factors, actors, and sectors that influence health, and are a primary driver of challenges of insufficient implementation, sustainment, and scale of evidence-based public health interventions. Implementation science frameworks have been developed to help embed evidence-based interventions in diverse settings and identify key factors that facilitate or hinder implementation. These frameworks are largely static in that they do not explain the nature and dynamics of interrelationships among the identified determinants, nor how those determinants might change over time. Furthermore, most implementation science frameworks are top-down, deterministic, and linear, leaving critical gaps in understanding of both how to intervene on determinants of successful implementation and how to scale evidence-based solutions. Design thinking and systems science offer methods for transforming this problem-oriented paradigm into one that is solution-oriented. This article describes these two approaches and how they can be integrated into implementation science strategies to promote implementation, sustainment, and scaling of public health innovation, ultimately resulting in transformative systems changes that improve population health.

Assessing the safety of bioactive ingredients in infant formula that affect the immune system: recommendations from an expert panel.

Bioactive ingredients for infant formula have been sought to reduce disparities in health outcomes between breastfed and formula-fed infants. Traditional food safety methodologies have limited ability to assess some bioactive ingredients. It is difficult to assess the effects of nutrition on the infant immune system because of coincident developmental adaptations to birth, establishment of the microbiome and introduction to solid foods, and perinatal environmental factors. An expert panel was convened to review information on immune system development published since the 2004 Institute of Medicine report on evaluating the safety of new infant formula ingredients and to recommend measurements that demonstrate the safety of bioactive ingredients intended for that use. Panel members participated in a 2-d virtual symposium in November 2020 and in follow-up discussions throughout early 2021. Key topics included identification of immune system endpoints from nutritional intervention studies, effects of human milk feeding and human milk substances on infant health outcomes, ontologic development of the infant immune system, and microbial influences on tolerance. The panel explored how "nonnormal" conditions such as preterm birth, allergy, and genetic disorders could help define developmental immune markers for healthy term infants. With consideration of breastfed infants as a reference, ensuring proper control groups, and attention to numerous potential confounders, the panel recommended a set of standard clinical endpoints including growth, response to vaccination, infection and other adverse effects related to inflammation, and allergy and atopic diseases. It compiled a set of candidate markers to characterize stereotypical patterns of immune system development during infancy, but absence of reference ranges, variability in methods and populations, and unreliability of individual markers to predict disease prevented the panel from including many markers as safety endpoints. The panel's findings and recommendations are applicable for industry, regulatory, and academic settings, and will inform safety assessments for immunomodulatory ingredients in foods besides infant formula.

Reducing Sodium Intake in Children: A Public Health Investment.

The antecedents of elevated blood pressure (BP) and its major consequences (cardiovascular disease and stroke) begin in childhood. Higher levels of BP early in life track into adulthood and are associated with subclinical target organ damage in children and adults. Diet behaviors, including the choice of high sodium containing foods, are established during childhood. On average, children, ages 2-19, consume more than 3,100 mg of sodium per day, with substantially greater sodium intakes in boys than girls. Importantly, studies show that lowering sodium intake in children lowers blood pressure. In view of this evidence, U.S. Dietary Guidelines recommend a reduced sodium intake in children. Current federal nutrition standards include a step-wise reduction in the sodium levels of school meals. The ultimate goal is to help children achieve daily sodium intakes that do not exceed upper levels recommended by the Institute of Medicine and the Dietary Guidelines for Americans. In summary, available data are sufficiently strong to recommend a lower sodium intake beginning in early in life as an effective and well-tolerated approach to reducing BP in children. Current efforts to weaken nutrition standards for school meals undermine an effective strategy aimed at improving the health of our children and our nation.