Food safety assessment and 28-day toxicity study of the synbiotic medical food consortium SBD121.

The human gut microbiome plays a crucial role in immune function. The synbiotic consortium or Defined Microbial Assemblage™ (DMA™) Medical Food product, SBD121, consisting of probiotic microbes and prebiotic fibers was designed for the clinical dietary management of rheumatoid arthritis. A 28-day repeated administration study was performed to evaluate the oral toxicity of SBD121 in male and female rats (age/weight at study start: 60 days/156-264 g) administered levels of 0, 4.96 x 1010, 2.48 x 1011, or 4.96 x 1011 colony forming units (CFU)/kg-bw. No treatment related changes were observed in ophthalmological effects, mortality, morbidity, general health and clinical observations, urinalysis, hematology, serum chemistry, absolute or relative organ weights, gross necropsy, or histopathology. A significant decrease in body weight was reported in females in the low and high-concentration groups, which corresponded in part with a significant decrease in food consumption. Results of the functional observation battery indicated front grip strength was significantly greater in the high-concentration males compared to the controls; however, this effect was not considered adverse. Based on these findings, the administration of the Medical Food SBD121 to male and female rats has a no-observable adverse effect level (NOAEL) at the highest level tested of 4.96 x 1011 CFU/kg-bw.

Clinical Nurse Specialist Role Advocacy: Quantifying the Financial Contributions Via Development of a Scorecard.

PURPOSE/OBJECTIVES: The purpose of this article is to guide the clinical nurse specialist in constructing a scorecard to track clinical outcomes and identify the associated financial impact. DESCRIPTION OF THE PROJECT/PROGRAM: Creation of a scorecard highlighting the financial impact of the clinical nurse specialist team was used to disseminate financial outcomes to hospital executive stakeholders, allowing the clinical nurse specialist team to demonstrate its clinical and financial value. OUTCOME: During development and ongoing maintenance of the scorecard, the clinical nurse specialist team cultivated skills to identify the financial impact of projects. The team also utilized financial implications of individual and group projects to prioritize work. At the end of fiscal year 2022, the clinical nurse specialist team demonstrated revenue generation of $29 890 and cost avoidance of $2 854 807.30. The clinical nurse specialist scorecard was presented quarterly to the chief nursing officer, who shared with executive leadership. CONCLUSION: Clinical nurse specialists are positioned to make significant and positive financial impact to organizations. A scorecard presented to executive leadership offers a clinical nurse specialist team a tool to capture and disseminate a clinical nurse specialist team's unique financial contribution at the system level.

Research gaps and emerging priorities in sexual and reproductive health in Africa and the eastern Mediterranean regions.

BACKGROUND: In-country research capacity is key to creating improvements in local implementation of health programs and can help prioritize health issues in a landscape of limited funding. Research prioritization has shown to be particularly useful to help answer strategic and programmatic issues in health care, including sexual and reproductive health (SRH). The purpose of this paper is to present the results of a priority setting exercise that brought together researchers and program managers from the WHO Africa and Eastern Mediterranean regions to identify key SRH issues. METHODS: In June 2015, researchers and program managers from the WHO Africa and Eastern Mediterranean regions met for a three-day meeting to discuss strategies to strengthen research capacity in the regions. A prioritization exercise was carried out to identify key priority areas for research in SRH. The process included five criteria: answerability, effectiveness, deliverability and acceptability, potential impact of the intervention/program to improve reproductive, maternal and newborn health substantially, and equity. RESULTS: The six main priorities identified include: creation and investment in multipurpose prevention technologies, addressing adolescent violence and early pregnancy (especially in the context of early marriage), improved maternal and newborn emergency care, increased evaluation and improvement of adolescent health interventions including contraception, further focus on family planning uptake and barriers, and improving care for mothers and children during childbirth. CONCLUSION: The setting of priorities is the first step in a dynamic process to identify where research funding should be focused to maximize health benefits. The key elements identified in this exercise provides guidance for decision makers to focus action on identified research priorities and goals. Prioritization and identifying/acting on research gaps can have great impact across multiple sectors in the regions for improved reproductive, maternal and children health.

Family planning and Zika virus: need for renewed and cohesive efforts to ensure availability of intrauterine contraception in Latin America and the Caribbean.

OBJECTIVES: The advantages of intrauterine contraception (IUC) are well established (highly effective, low discontinuation rate, easy to use, low cost, and suitable for immediate postpartum use), but low levels of use in many countries and declining use in others are causes for concern. Due to the ongoing Zika virus outbreak, public health officials are calling for the continued practice of safe sex and the delay of pregnancy. Our study was conducted to assess the current situation of IUC availability and provision in Latin America and to determine the role of national policies in meeting the contraceptive needs of the populations in these countries. METHODS: A survey was conducted in Latin America and the Caribbean between December 2015 and January 2016 to assess national policies with regard to IUC provision, availability and accessibility. 18 countries participated. RESULTS: All responding countries had national policies on IUC. Many in the public sector provided the intrauterine device (IUD) free of charge, but the levonorgestrel-releasing intrauterine system (LNG-IUS) was generally available in the private sector. Some countries had very restrictive policies on who was permitted to carry out IUC insertions, but most permitted a range of health professionals to do so. Immediate postpartum IUC insertion was uncommon. Some countries placed restrictions on IUC use in women who were nulliparous, young, at high risk of catching a sexually transmitted infection or who had multiple sexual partners. CONCLUSIONS: IUC is underused in Latin America. The study reveals policy level barriers that may impede access to IUC, one of the most effective, long-acting, non-hormonal, reversible contraceptive methods. Governments should consider reviewing and rethinking their policies on contraception to ensure IUC service provision among populations at high risk of unplanned pregnancy, especially those vulnerable to Zika virus.

A study protocol for facility assessment and follow-up evaluations of the barriers to access, availability, utilization and readiness of contraception, abortion and postabortion services in Zika affected areas.

BACKGROUND: The Zika virus epidemic in Latin America has elicited official recommendations for women to delay or avoid pregnancy in affected countries, which has increased demand for family planning services. It is likely, however, that health facilities in areas where the population is most vulnerable to the disease lack the capacity to respond to the increased demand for family planning services. Our objectives are to perform facilities assessment and understand client perceptions in areas affected by Zika virus, and to track changes in these parameters over time. METHODS/DESIGN: We will collaborate with local health authorities to map facilities that have the capacity to provide services in contraception and safe abortion, including induced abortion to the full extent of the law and post-abortion care for treatment of complications from unsafe abortion and post-abortion contraception. We then will carry out a survey of facilities to assess the availability of services and their readiness to provide contraception and safe abortion care. All facilities will be assessed for baseline readiness and availability of services, and a random subsample of surveyed facilities will be reassessed in second and third rounds of surveys. Focus group interviews with clients will be conducted as part of the facilities surveys in order to gain an understanding of the community's knowledge, needs and perceived barriers to healthcare in the context of the Zika virus epidemic. DISCUSSION: The findings of this study will aid the response to Zika virus ranging from the identification of healthcare facilities that can be potentially strengthened, to the formulation of interventions to reduce barriers and improve readiness of facilities to provide contraception and safe abortion services. Lessons learned from this study will help to build and strengthen health systems that are more prepared to consistently providing reproductive healthcare services in the context of health emergencies.

Study protocol on establishment of sentinel sites network for contraceptive and abortion trends, needs and utilization of services in Zika virus affected countries.

BACKGROUND: ZIKV(Zika Virus) during pregnancy can result in many adverse events such as fetal deaths or newborns with congenital abnormalities including microcephaly and other neural irregularities. Due to these harmful outcomes of pregnancy associated with the Zika virus, we can expect to see a change in the type and scale of demand for family planning and safe abortion services in areas affected by the Zika virus. The monitoring and reporting capacities of the local health clinics in these areas could benefit from the introduction of infrastructural improvements necessary to establish a sentinel site network. Through these sites, the WHO will collect data on the situation from local health professionals to get real time information from the population group and act accordingly to mitigate the consequences of the Zika virus outbreak in a localized and culturally appropriate way. The objectives are to establish a sentinel sites surveillance network for reporting on uptake and utilization of contraception and safe abortion care services; to strengthen monitoring, and data quality assurance in the selected sentinel surveillance sites; and finally to assess the contraception and safe abortion care service utilization trends in the affected sites on a regular basis. METHODS: The proposal includes a set of objectives and actions that enable the creation of a set of criteria for the selection of the sentinel sites, as well the implementation of monitoring and reporting systems that will be used in data collection. DISCUSSION: The data collected will be used to better understand the changing demand for family planning and safe abortion needs. This will ultimately be used to inform local health workers and policy makers as to how best to track the continued Zika virus outbreak and mitigate the consequences. The learning from establishment of surveillance sentinel sites will help to strengthen health systems at regional and subregional levels that are more adaptable and capable of providing reproductive healthcare services and of responding to future emergencies.

Assessment of cytochrome P450 1A in harbour seals (Phoca vitulina) using a minimally-invasive biopsy approach.

Biomarkers of organochlorine exposure, such as the induction of cytochrome P450 1A (CYP1A), can be used to assess the impact of environmental contaminants on the health of free-ranging marine mammal populations. The objective of the present study was to measure CYP1A in skin and liver biopsies obtained from live harbour seals (Phoca vitulina). Twelve harbour seal pups, aged three to five weeks, were captured from the Fraser River estuary, British Columbia, Canada, and temporarily held in captivity. Skin ( approximately 60 mg) and liver ( approximately 40 mg) biopsies, obtained while seals were under general anaesthesia, yielded sufficient tissue for the measurement of CYP1A by immunoblot analysis and ethoxyresorufin O-deethylase activity. A short-term exposure experiment, in which harbour seals (n=3) were treated orally with beta-naphthoflavone (BNF), resulted in increased hepatic and cutaneous CYP1A protein levels, consistent with observations in other mammals. This study is the first to measure CYP1A in skin and liver biopsies from live harbour seals and to report in vivo BNF-associated CYP1A induction in a marine mammal. The results demonstrate that microsamples collected using minimally-invasive techniques can provide toxicologically-relevant information form marine mammals.