Perceptions of Beverages With Non-nutritive Sweeteners Among Indigenous Adults Living in Manitoba and Implications for Type 2 Diabetes.

OBJECTIVES: The purpose of this study was to explore the perspectives of Indigenous adults on consuming beverages with non-nutritive sweeteners. METHODS: In this work, we used a community-based, participatory design in partnership with National Indigenous Diabetes Association, Four Arrows Regional Health Authority, and Fearless R2W. We conducted 74 qualitative interviews with Indigenous adults living in Manitoba, including Island Lake First Nations (n=39), Flin Flon (n=15), and the North End neighbourhood of Winnipeg (n=20). Data were indexed in NVivo, and transcripts were analyzed thematically. RESULTS: Participants exclusively discussed beverages with non-nutritive sweeteners (BNNSs) as an alternative to regular pop or sugary drinks, which were widely available, accessible, and consumed. Why or how BNNSs were viewed as an alternative comprised 3 subthemes: an alternative for health reasons; divergent taste preferences; and an alternative with mysterious but negative health effects. Participants who reported regular consumption of BNNSs largely described consuming them to manage type 2 diabetes. Fewer participants discussed BNNS as a means of weight management or as a preventive health behaviour. Participants who did not report regular BNNS consumption described not liking the taste of BNNSs. Finally, many participants described negative health impacts of consuming BNNSs, and specifically aspartame, although few articulated what those negative impacts were. CONCLUSIONS: Divergent perspectives among Indigenous adults regarding the health implications of consuming BNNSs may reflect ongoing scholarly debates. These findings have implications for the prevention and dietary management of type 2 diabetes in Indigenous communities.

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Detection and population genomics of sea turtle species via noninvasive environmental DNA analysis of nesting beach sand tracks and oceanic water.

Elusive aquatic wildlife, such as endangered sea turtles, are difficult to monitor and conserve. As novel molecular and genetic technologies develop, it is possible to adapt and optimize them for wildlife conservation. One such technology is environmental (e)DNA - the detection of DNA shed from organisms into their surrounding environments. We developed species-specific green (Chelonia mydas) and loggerhead (Caretta caretta) sea turtle probe-based qPCR assays, which can detect and quantify sea turtle eDNA in controlled (captive tank water and sand samples) and free ranging (oceanic water samples and nesting beach sand) settings. eDNA detection complemented traditional in-water sea turtle monitoring by enabling detection even when turtles were not visually observed. Furthermore, we report that high throughput shotgun sequencing of eDNA sand samples enabled sea turtle population genetic studies and pathogen monitoring, demonstrating that noninvasive eDNA techniques are viable and efficient alternatives to biological sampling (e.g., biopsies and blood draws). Genetic information was obtained from sand many hours after nesting events, without having to observe or interact with the target individual. This greatly reduces the sampling stress experienced by nesting mothers and emerging hatchlings, and avoids sacrificing viable eggs for genetic analysis. The detection of pathogens from sand indicates significant potential for increased wildlife disease monitoring capacity and viral variant surveillance. Together, these results demonstrate the potential of eDNA approaches to ultimately help understand and conserve threatened species such as sea turtles.

Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies.

BACKGROUND: The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs. OBJECTIVES: We aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies. METHODS: For both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers. RESULTS: We identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years. CONCLUSIONS: The CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.

Transcatheter valve therapy registry is a model for medical device innovation and surveillance.

Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare. This article examines the Transcatheter Valve Therapy Registry, which captures clinical information on all US patients undergoing new nonsurgical heart valve treatments. The registry has patient-level data from more than 27,000 patients treated with the novel devices. Patient- and procedure-related data are gathered from hospitals, patient-reported outcomes are assessed pre- and postprocedure, and longer-term data on mortality and repeat hospitalization are provided by linking the registry's data to Medicare patient data. The registry is a model of collaboration among professional societies, the FDA, the Centers for Medicare and Medicaid Services, hospitals, patients, and the medical device industry. It has been used to support Medicare coverage decisions, expand device indications, provide comprehensive device surveillance, and establish national quality benchmarks. Beyond having it serve as a collaborative model, future goals for the registry include shortening the FDA-approval timeline for devices, providing data for decision-making tools for patients, and public reporting of hospital performance.

Peer mentoring for type 2 diabetes prevention in first nations children.

OBJECTIVE: The goal of this study was to assess the efficacy of an after-school, peer-led, healthy living program on adiposity, self-efficacy, and knowledge of healthy living behaviors in children living in a remote isolated First Nation. METHODS: A quasi-experimental trial with a parallel nonequivalent control arm was performed with 151 children in Garden Hill First Nation during the 2010-2011 and 2011-2012 school years. Fourth grade students were offered a 5-month, peer-led intervention facilitated by high school mentors between January and May of each school year; students in the control arm received standard curriculum. The main outcome measures were waist circumference (WC) and BMI z score. Secondary outcome measures included healthy living knowledge and self-efficacy. RESULTS: Fifty-one children (mean ± SD age: 9.7 ± 0.4 years; BMI z score: 1.46 ± 0.84) received the intervention, and 100 children were in the control arm. At baseline, WC (79.8 vs 83.9 cm), BMI z score (1.46 vs 1.48), and rates of overweight/obesity (75% vs 72%) did not differ between arms. After the intervention, the change in WC (adjusted treatment effect: -2.5 cm [95% confidence interval (CI): -4.1 to -0.90]; P = .002) and BMI z score (adjusted treatment effect: -0.09 [95% CI: -0.16 to -0.03]; P = .007) were significantly lower in the intervention arm compared to the control arm. The intervention arm also experienced improvements in knowledge of healthy dietary choices (2.25% [95% CI: -0.01 to 6.25]; P = .02). Self-efficacy was associated with the change in WC after the intervention (ß = -7.9, P = .03). CONCLUSIONS: An after-school, peer-led, healthy living program attenuated weight gain and improved healthy living knowledge in children living in a remote isolated First Nation.

Synthesis and sulfur oxygenation of a (N3S)Ni complex related to nickel-containing superoxide dismutase.

A nickel(II) thiolate complex incorporating three N-donor types (amino, amido, and imidazole) has been synthesized and characterized. The (N(3)S)Ni complex, [N-{2-[(2-mercapto-2-methylpropyl)amino]ethyl}-1-methylimidazole-2-carboxamido]nickel(II) (1), is stable in the presence of O(2) but readily forms the sulfinato (RSO(2)(-)) derivative 2 upon the addition of H(2)O(2). Electrochemical investigations of 1 reveal an irreversible sulfur-based oxidation at +0.17 V vs Fc(+)/Fc (200 mV/s) that shifts to +0.81 V upon oxidation to 2. Density functional theory investigations of 1 reveal a highest occupied molecular orbital that is predominantly sulfur-based, consistent with the observed sulfur-based oxidation and O(2) stability.

Fluctuations of dissolved organic matter in river used for drinking water and impacts on conventional treatment plant performance.

Natural organic matter (NOM) in drinking water supplies can provide precursors for disinfectant byproducts, molecules that impact taste and odors, compounds that influence the efficacy of treatment, and other compounds that are a source of energy and carbon for the regrowth of microorganisms during distribution. NOM, measured as dissolved organic carbon (DOC), was monitored daily in the White River and the Indiana-American water treatment plant over 22 months. Other parameters were either measured daily (UV-absorbance, alkalinity, color, temperature) or continuously (turbidity, pH, and discharge) and used with stepwise linear regressions to predict DOC concentrations. The predictive models were validated with monthly samples of the river water and treatment plant effluent taken over a 2-year period after the daily monitoring had ended. Biodegradable DOC (BDOC) concentrations were measured in the river water and plant effluent twice monthly for 18 months. The BDOC measurements, along with measurements of humic and carbohydrate constituents within the DOC and BDOC pools, revealed that carbohydrates were the organic fraction with the highest percent removal during treatment, followed by BDOC, humic substances, and refractory DOC.

Strength/power augmentation subsequent to short-term training abstinence.

Strength augmentation has been demonstrated in resistance-trained men subsequent to 4 days of training abstinence. However, this phenomenon was exhibited in an unusual circumstance in which the exercise test (seated heel raise) primarily involved an isolated skeletal muscle (soleus) that is normally comprised almost exclusively of 1 fiber type. It is unclear if similar results would be found for aggregate muscle actions. Therefore, a comparable study was designed with this in mind. Subjects were apparently healthy, young, strength-trained men (n = 25). All performed various tests of bench press strength at the beginning of their last standardized dynamic constant external resistance (DCER) training session. Subjects were subsequently randomly assigned to 1 of 4 groups and repeated the identical tests at intervals of either 2, 3, 4, or 5 days with no intervening training. Strength tests consisted of 1 repetition maximum (1RM) concentric-only isokinetic bench presses performed at 1.49 and 0.37 m.s(-1) as well as a 1RM DCER bench press. Measures of peak force and power were obtained from the isokinetic tests and maximum load from the DCER test. Results were expressed in both absolute and relative (to body weight) terms. Subsequent to the 4 abstinence intervals, groups performed similarly (p > 0.05) for all dependent variables. Concurrently, however, a small effect size (ES) was found for the group having a 4-day respite for both absolute and relative expressions of peak force and power at the slowest isokinetic bench press velocity. A small ES was also identified for the group having 2 days of rest for relative peak force at the slowest isokinetic test velocity and for relative DCER strength. Therefore, modest and transient strength augmentation appears likely in aggregate muscle actions following 2-4 days of training abstinence in resistance-trained men, but only at relatively slow velocities.

Evaluation of L-selectin expression and assessment of protein tyrosine phosphorylation in bovine polymorphonuclear neutrophil leukocytes around parturition.

Impaired polymorphonuclear neutrophil leukocyte (PMN) function around parturition has been associated with increased clinical mastitis in dairy cows. Rolling and attachment of PMN to the endothelium is the first step in the recruitment process and is accomplished by interaction between L-selectin on PMN and its ligand on endothelial cells. Furthermore, tyrosine phosphorylation is involved in the initiation of many PMN functions. The objective of this work was to determine changes in expression of L-selectin and tyrosine phosphorylation in the perinatal period. Eight clinically healthy Holstein cows were used as PMN donors at d-21, -14, -7,0 (calving), +1, +2, +7, +14, +28. Evaluation of L-selectin expression was carried out on activated and resting PMN. Anti-bovine L-selectin monoclonal antibody (MAB) and flow cytometric analysis were used to measure the percentage of PMN fluorescing and receptor expression (log mean fluorescent channel, LMFC). Activated and resting PMN showed similar trends in % PMN fluorescence and LM FC. The percentage of PMN fluorescing tended to decrease at parturition, followed by a significant increase at d +14 and +28 (P < 0.02). For LMFC a decrease was observed on d +1 followed by an increase through d +28 (P < 0.01). Protein tyrosine phosphorylation of lysates prepared from PMN isolated throughout the study was detected by electrophoresis and western blotting using anti-phosphotyrosine MAB. Several protein bands were tyrosine phosphorylated. Two of these bands (42-44 kDa and 90 kDa) varied in intensity over time. The intensity of the 42-44 kDa band gradually increased from d -7, peaked at d +7 (P < 0.03), and steadily decreased to d +28 (P < 0.02). Antibody to activated mitogen protein kinase reacted with the 42-44 kDa band. Reduced PMN function during the periparturient period could be related to reduced L-selectin adhesion molecules on the cell surface, and to modulation in the phosphorylation of functionally important molecules.

Monitoring dissolved organic carbon in surface and drinking waters.

The presence of natural organic matter (NOM) strongly impacts drinking water treatment, water quality, and water behavior during distribution. Dissolved organic carbon (DOC) concentrations were determined daily over a 22 month period in river water before and after conventional drinking water treatment using an on-line total organic carbon (TOC) analyzer. Quantitative and qualitative variations in organic matter were related to precipitation and runoff, seasons and operating conditions. Following a rainfall event, DOC levels could increase by 3.5 fold over baseflow concentrations, while color, UV absorbance values and turbidity increased by a factor of 8, 12 and 300, respectively. Treated water DOC levels were closely related to the source water quality, with an average organic matter removal of 42% after treatment.