Medical devices historically have been monolithic units -developed, validated, and approved by regulatory authorities as stand-alone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single customizable displays, and coordinate the actions of groups of cooperating devices to realize "closed loop" scenarios and automate clinical workflows.In this paper, we describe a publish-subscribe architecture for medical device integration based on the Java Messaging Service. We overview of a model-based development environment that we have built for rapidly programming device coordination scenarios. We assess the extent to which this framework is capable of supporting and complementing the Integrated Clinical Environment that has been proposed by the Medical Device Plug and Play Interoperability Project The implementation of this framework is free available and open source. One of the primary goals of the framework is to provide researchers in acadaemia, industry, and government with an open test bed for exploring development, quality assurance, and regulatory issues related to medical device coordination.
Fortified blended foods (FBFs) are micronutrient-fortified blends of milled cereals and pulses that represent the most commonly distributed micronutrient-fortified food aid. FBFs have been criticized due to lack of efficacy in treating undernutrition, and it has also been suggested that alternative commodities, such as sorghum and cowpea, be investigated instead of corn and soybean. The Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania efficacy study was the culmination of economic, processing, sensory, and nutrition FBF research and development. MFFAPP Tanzania was a 20-wk, partially randomized cluster design conducted between February and July 2016 that enrolled children aged 6–53 mo in the Mara region of Tanzania with weight-for-height z scores >−3 and hemoglobin concentrations <10.3 mg/dL. The intervention was complementary feeding of newly formulated, extruded FBFs (white sorghum cowpea variety 1, white sorghum-cowpea variety 2, red sorghum-cowpea, white sorghum-soy blend, and corn-soy blend 14) compared with Corn Soy Blend Plus (CSB+), a current US Agency for International Development–distributed corn-soy blend, and a no-FBF-receiving control. Screened participants (n = 2050) were stratified by age group (6–23 and 24–53 mo) and allocated to 1 of 7 FBF clusters provided biweekly. Biochemical and anthropometric data were measured every 10 wk at weeks 0, 10, and 20. The primary objectives of this study were to determine whether newly formulated, extruded corn-, soy-, sorghum-, and cowpea-based FBFs result in equivalent vitamin A or iron outcomes compared with CSB+. Changes in anthropometric outcomes were also examined. Results from the MFFAPP Tanzania Efficacy Study will inform food aid producers and distributers about whether extruded sorghum- and cowpea-based FBFs are viable options for improving the health of the undernourished. This trial was registered at clinicaltrials.gov as NCT02847962.
Medical devices historically have been monolithic units -developed, validated, and approved by regulatory authorities as standalone entities. Despite the fact that modern medical devices increasingly incorporate connectivity mechanisms that enable device data to be streamed to electronic health records and displays that aggregate data from multiple devices, connectivity is not being leveraged to allow an integrated collection of devices to work together as a single system to automate clinical work flows. This is due, in part, to current regulatory policies which prohibit such interactions due to safety concerns. In previous work, we proposed an open source middleware framework and an accompanying model-based development environment that could be used to quickly implement medical device coordination applications -enabling a "systems of systems" paradigm for medical devices. Such a paradigm shows great promise for supporting many applications that increase both the safety and effectiveness of medical care as well as the efficiency of clinical workflows. In this paper, we report on our experience using our Medical Device Coordination Framework (MDCF) to carry out a rapid prototyping of one such application -a multi-device medical system that uses closed loop physiologic control to a affect better patient outcomes for Patient Controlled Anelgesic (PCA) pumps. ABSTRACTMedical devices historically have been monolithic units -developed, validated, and approved by regulatory authorities as standalone entities. Despite the fact that modern medical devices increasingly incorporate connectivity mechanisms that enable device data to be streamed to electronic health records and displays that aggregate data from multiple devices, connectivity is not being leveraged to allow an integrated collection of devices to work together as a single system to automate clinical work flows. This is due, in part, to current regulatory policies which prohibit such interactions due to safety concerns.In previous work, we proposed an open source middleware framework and an accompanying model-based development environment that could be used to quickly implement medical device coordination applications -enabling a "systems of systems" paradigm for medical devices. Such a paradigm shows great promise for supporting many applications that increase both the safety and effectiveness of medical care as well as the efficiency of clinical workflows. In this paper, we report on our experience using our Medical Device Coordination Framework (MDCF) to carry out a rapid prototyping of one such application -a multi-device medical system that uses closed loop physiologic control to a affect better patient outcomes for Patient Controlled Anelgesic (PCA) pumps.
Overall, centers lacked parental outreach, staff training, and funding/resources to support nutrition and PA. These results provide insight into where child care centers within low-income, rural communities may need assistance to help prevent childhood obesity.
BackgroundThe Ecological Model of Childhood Overweight focuses on characteristics that could affect a child’s weight status in relation to the multiple environments surrounding that child. A community coaching approach allows community groups to identify their own strengths, priorities and identity. Little to no research currently exists related to community-based efforts inclusive of community coaching in creating environmental change to prevent childhood obesity particularly in rural communities.MethodsA quasi-experimental study will be conducted with low-income, rural communities (n = 14) in the North Central region of the United States to mobilize capacity in communities to create and sustain an environment of healthy eating and physical activity to prevent childhood obesity. Two rural communities within seven Midwestern states (IN, KS, MI, OH, ND, SD, WI) will be randomly assigned to serve as an intervention or comparison community. Coalitions will complete assessments of their communities, choose from evidence-based approaches, and implement nutrition and physical activity interventions each year to prevent childhood obesity with emphasis on policy, system or environmental changes over four years. Only intervention coalitions will receive community coaching from a trained coach. Outcomes will be assessed at baseline, annually and project end using previously validated instruments and include coalition self-assessments, parental perceptions regarding the built environment, community, neighborhood, and early childhood environments, self-reflections from coaches and project staff, ripple effect mapping with coalitions and, final interviews of key stakeholders and coaches. A mixed-methods analysis approach will be used to evaluate if Community Coaching enhances community capacity to create and sustain an environment to support healthy eating and physical activity for young children. ANOVA or corresponding non-parametric tests will be used to analyze quantitative data relating to environmental change with significance set at P < .05. Dominant emergent themes from the qualitative data will be weaved together with quantitative data to develop a theoretical model representing how communities were impacted by the project.DiscussionThis project will yield data and best practices that could become a model for community development based approaches to preventing childhood obesity in rural communities.
Although breastfeeding for longer duration appeared to be protective against overweight among 4-year-old non-Hispanic children, cultural and environmental factors may override this protective benefit.
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