Newly recognized as natural nanocarriers that deliver biological information between cells, extracellular vesicles (EVs), including exosomes and microvesicles, provide unprecedented therapeutic opportunities. Large-scale and cost-effective manufacturing is imperative for EV products to meet commercial and clinical demands; successful translation requires careful decisions that minimize financial and technological risks. Here, we develop a decision support tool (DST) that computes the most cost-effective technologies for manufacturing EVs at different scales, by examining the costs of goods associated with using published protocols. The DST identifies costs of labor and consumables during EV harvest as key cost drivers, substantiating a need for larger-scale, higher-throughput, and automated technologies for harvesting EVs. Importantly, we highlight a lack of appropriate technologies for meeting clinical demands, and propose a potentially cost-effective solution. This DST can facilitate decision-making very early on in development and be used to predict, and better manage, the risk of process changes when commercializing EV products.
In 2014, the Affordable Care Act will create an estimated 16 million newly insured people. Coupled with an estimated shortage of over 60,000 primary care physicians, the country's public health care system will be at a challenging crossroads, as there will be more patients waiting to see fewer doctors. Nurse practitioners (NPs) can help to ease this crisis. NPs are health care professionals with the capability to provide important and critical access to primary care, particularly for vulnerable populations. However, despite convincing data about the quality of care provided by NPs, many managed care organizations (MCOs) across the country do not credential NPs as primary care providers, limiting the ability of NPs to be reimbursed by private insurers. To assess current credentialing practices of health plans across the United States, a brief telephone survey was administered to 258 of the largest health maintenance organizations (HMOs) in the United States, operated by 98 different MCOs. Results indicated that 74% of these HMOs currently credential NPs as primary care providers. Although this represents progress over prior assessments, findings suggest that just over one fourth of major HMOs still do not recognize NPs as primary care providers. Given the documented shortage of primary care physicians in low-income communities in the United States, these credentialing policies continue to diminish the ability of NPs to deliver primary care to vulnerable populations. Furthermore, these policies could negatively impact access to care for thousands of newly insured Americans who will be seeking a primary care provider in 2014.
Despite benefits to sharing data among public health programs, confidentiality laws are often presumed to obstruct collaboration or data sharing. We present an overview of the use and release of confidential, personally identifiable information as consistent with public health interests and identify opportunities to align data-sharing procedures with use and release provisions in state laws to improve program outcomes. In August 2013, Centers for Disease Control and Prevention staff and legal researchers from the National Nurse-Led Care Consortium conducted a review of state laws regulating state and local health departments in 50 states and the District of Columbia. Nearly all states and the District of Columbia employ provisions for the general use and release of personally identifiable information without patient consent; disease-specific use or release provisions vary by state. Absence of law regarding use and release provisions was noted. Health departments should assess existing state laws to determine whether the use or release of personally identifiable information is permitted. Absence of direction should not prevent data sharing but prompt an analysis of existing provisions in confidentiality laws.
Inflammatory bowel disease (IBD) is a term for two autoimmune diseases encompassing Crohn’s disease (CD) and ulcerative colitis (UC) which are lifelong diseases affecting more than 3 million adults (1.3%) in the United States. IBD is characterized by chronic inflammation of the whole digestive system which results in damage to the gastrointestinal (GI) tract. IBD often emerges during adolescence and young adulthood. Maternal morbidity includes physical and psychological conditions that result from or are aggravated by pregnancy and have an adverse effect on a woman’s health, the baby’s health or both. Some women have health challenges that arise before or during pregnancy that could lead to complications. It is recommended for women to receive health care counseling before and during pregnancy. Compared to other developed countries, the United States has the highest rate of women dying of pregnancy related complications. During the past 25 years maternal mortality has been getting worse. African American women (AAW) with and/or without IBD are dying at significantly higher rates than other groups. This is linked to several factors, i.e., systemic, institutionalized, and structural racism in health-care delivery and subsequent toxic stress from people’s lived experiences of racism, limited knowledge about healthcare system function, lack of access to healthcare, (inclusiveness and insurance policies) all of which negatively impact these patients. African Americans (AAs) are also up to three times as likely to experience severe maternal morbidity: unexpected outcomes of labor and delivery, deficient or lacking prenatal care and social determinants of health like lack of transportation, adequate employment, limited literacy, and limited healthcare access contribute to poor health outcomes. Studies on IBD patients indicate Medicaid expansion is associated with reduced rates of maternal morbidity, particularly for African American Women (AAW) and increased access to preconception and prenatal services that make pregnancy and childbirth safer for parent and baby. Herein we examine the physiological changes of pregnancy in patients diagnosed with inflammatory bowel disease and their relationship perinatal outcomes and parenthood.
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