Arguments Used in Public Comments to Support or Oppose the US Department of Agriculture’s Minimum Stocking Requirements: A Content Analysis

Background

In 2016, the US Department of Agriculture (USDA)’s Supplemental Nutrition Assistance Program (SNAP) Retailer Rule proposed several changes for SNAP-authorized retailers, including: requiring retailers to have at least 85% of their food sales come from items that are not cooked or heated on site before or after purchase; requiring stores to stock seven varieties of qualifying foods from four staple food groups; requiring stores to carry perishable foods in three of the four staple groups; requiring stores to carry six units of qualifying foods at all times (depth of stock); disqualifying multiple ingredient foods and accessory foods from counting toward depth of stock requirements.

Dynamic changes of the composition of plasma HDL particles in patients with cardiac disease: Spotlight on sphingosine‐1‐phosphate/serum amyloid A ratio

Several epidemiological studies reported an inverse relationship between plasma high‐density lipoprotein (HDL) cholesterol levels and atherosclerotic cardiovascular disease (ASCVD). However, therapeutic interventions targeted at raising HDL‐cholesterol failed to improve cardiovascular outcomes, suggesting that HDL components distinct from cholesterol may account for the anti‐atherothrombotic effects attributed to this lipoprotein. Sphingosine‐1‐phosphate (S1P) and the acute phase protein serum amyloid A (SAA) have been identified as integral constituents of HDL particles. Evidence suggests that S1P and SAA levels within HDL particles may be affected by inflammation and oxidative stress, which are coexisting processes underlying ASCVD. Because SAA, an inflammation‐related marker, and S1P, an anti‐atherothrombotic marker, have relatively clear opposite characteristics among the HDL‐associated proteins, the approach of assessing the two markers simultaneously may provide new insights in clinical practice (S1P/SAA Index). This review focuses on evidence in support of the concept that the S1P/SAA Index may affect the HDL atheroprotective properties and may, therefore represent a potential target for therapeutic interventions.     

AN INTERIM ANALYSIS OF A DOUBLE-BLIND SHAM-CONTROLLED STUDY ON THE ACUTE EFFECTS OF TRANSCRANIAL DIRECT CURRENT STIMULATION IN OBSESSIVE-COMPULSIVE DISORDER

We describe the interim analysis of a double-blind sham controlled quasi-randomized study on the acute effects of transcranial direct current stimulation (tDCS) for individuals with obsessive-compulsive disorder (OCD). Twenty OCD patients were assigned to receive a single session of sham (n=10) or active (2mA) tDCS (n=10) for 30 minutes, with the cathode placed over the central supplementary motor area (SMA) and the anode on the supraorbital region. Assessments of outcome were made at baseline and one hour following tDCS using: a dot-probe task comprising images illustrating different OCD-related scenarios, the Positive and Negative Affect Schedule (PANAS), and the Yale-Brown Obsessive-Compulsive Challenge Scale (YBOCCS; a measure of symptoms in the preceding hour). Active and sham tDCS groups did not differ in terms of age, gender, medication use and baseline severity of OCD, depression and anxiety symptoms. Though a significant time-effect (before vs. after tDCS) was observed on YBOCCS, PANAS and dot-probe scores, there was no interaction between groups. However, exploratory analyses revealed that sham tDCS led to a significant decrease in OCD symptoms in the past hour, while active tDCS failed to do so. Although we did not observe acute effects of tDCS on OCD symptoms, this interim analysis suggests that inhibition of the SMA may interfere with sham response in OCD, probably through increasing vigilance towards OCD-related environmental stimuli.     

Anti-GD2 Immunoliposomes for Targeted Delivery of the Survivin Inhibitor Sepantronium Bromide (YM155) to Neuroblastoma Tumor Cells

Purpose

Sepantronium bromide (YM155) is a hydrophilic quaternary compound that cannot be administered orally due to its low oral bioavailability; it is furthermore rapidly eliminated via the kidneys. The current study aims at improving the pharmacokinetic profile of YM155 by its formulation in immunoliposomes that can achieve its enhanced delivery into tumor tissue and facilitate uptake in neuroblastoma cancer cells.

Methods

PEGylated YM155 loaded liposomes composed of DPPC, cholesterol and DSPE-PEG₂₀₀₀ were prepared via passive film-hydration and extrusion method. Targeted (i.e. immuno-)liposomes were prepared by surface functionalization with SATA modified monoclonal anti-disialoganglioside (GD2) antibodies. Liposomes were characterized based on their size, charge, antibody coupling and YM155 encapsulation efficiency, and stability. Flow cytometry analysis and confocal microscopy were performed on IMR32 and KCNR neuroblastoma cell lines. The efficacy of developed formulations were assessed by in-vitro toxicity assays. A pilot pharmacokinetic analysis was performed to assess plasma circulation and tumor accumulation profiles of the developed liposomal formulations.

Results

YM155 loaded immunoliposomes had a size of 170 nm and zeta potential of ?10 mV, with an antibody coupling efficiency of 60% andYM155 encapsulation efficiency of14%. Targeted and control liposomal formulations were found to have similar YM155 release rates in a release medium containing 50% serum. An in-vitro toxicity study on KCNR cells showed less toxicity for immunoliposomes as compared to free YM155. In-vivo pharmacokinetic evaluation of YM155 liposomes showed prolonged blood circulation and significantly increased half-lives of liposomal YM155 in tumor tissue, as compared to a bolus injection of free YM155.

Conclusions

YM155 loaded immunoliposomes were successfully formulated and characterized, and initial in-vivo results show their potential for improving the circulation time and tumor accumulation of YM155.

     

First Nation Elders’ perspectives on healthy ageing in NSW,Australia

Objectives : Healthy ageing has been unattainable for many of Australia’s First Nation people, driven by an earlier onset of chronic disease when compared to the general Australian population. Our objective was to examine the perspectives of Australian First Nation people about healthy ageing. Methods : We used a conversational method to gather knowledge from older First Nation people from established communities in New South Wales, Australia. Discussions were audio recorded and transcribed and analysed using an Indigenous research standpoint methodology. Eight yarning circles were held in six locations with 76 participants aged 45 years and over. Results : Key issues around healthy ageing were identified; particularly, what the impact of chronic disease means to individuals. Study participants reported that healthy ageing is essential to continue to share knowledge of their history and culture. Conclusion : This article highlights the need for culturally appropriate healthy ageing programs addressing issues related to chronic disease among First Nation communities. Implications for public health : Research into what constitutes healthy ageing for older First Nation people is necessary for the development of culturally appropriate chronic disease interventions.     

Single‐item measure of food insecurity used in the National Health Survey may underestimate prevalence in Australia

Objectives : To compare prevalence estimates of food insecurity using a single‐item measure, with three adaptations of the United States Department of Agriculture Food Security Survey Module (USDA‐FSSM). Methods : Data were collected by postal survey, from individuals aged ≥18 years from disadvantaged suburbs of Brisbane, Australia (n= 505, 53% response). Food security status was ascertained by the Australian single‐item measure, and the 6‐, 10‐ and 18‐item versions of the USDA‐FSSM. Prevalence estimates of food insecurity and different levels of severity of food insecurity estimated by each tool were determined. Data were analysed using McNemar's test, polychoric correlation and Rasch analyses. Results : The prevalence of food insecurity was 19.5% using the single‐item measure; significantly less than the 24.4%, 22.8% and 21.1% identified using the 18‐item, 10‐item and 6‐item versions of the USDA‐FSSM, respectively. Rasch analyses revealed that overall the USDA‐FSSM may be a valid tool for the measurement of food insecurity within the current sample. Conclusion : The measure of food insecurity employed in national surveys in Australia may underestimate its prevalence and public health significance. Implications for public health : Future monitoring and surveillance efforts should seek to employ a more accurate measure as the first step in recognising the right to food for all Australians.     

High protein intake along with paternal part-time employment is associated with higher body fat mass among girls from South China

Purpose

Protein intake has been suggested to be associated with body composition among western children. Our aim was to determine whether protein intake is associated with body composition among Chinese children and to investigate whether parental socioeconomic status modifies these associations.

Methods

Cross-sectional data were collected from the baseline survey of an ongoing population-based prospective open cohort study conducted in 2013. In this survey, 2039 children in South China were recruited using cluster random sampling. Information of 1704 children (47% girls), aged 7–12 years from three primary schools (42 classes), on diet and anthropometry was included finally. Their daily protein intake was obtained by 3-day 24-h dietary recalls. Skinfold thickness, body height, and weight were measured to calculate percent body fat (%BF), fat mass index (FMI), and fat-free mass index (FFMI). Parental characteristics were collected by questionnaires.

Results

Among girls, protein intake was positively associated with %BF and FMI [estimate (SE) for %BF: 0.007 (0.003), p = 0.04; for FMI: 0.092 (0.002), p = 0.03], adjusted for pubertal stage, breast-feeding, maternal overweight, carbohydrate intake, energy intake, and physical activity level. Furthermore, there was interaction between paternal occupation and the relations of dietary protein with %BF and FMI (p _{for interaction} ≤ 0.04). None of the associations between protein intake and %BF, FMI, or FFMI was found among boys.

Conclusions

Our data indicate that school-aged girls, but not boys, living in South China with higher dietary protein intake might have higher body fat mass, which could be modified by paternal occupation.

     

Systemic absorption of nicotine following acute secondhand exposure to electronic cigarette aerosol in a realistic social setting

Evidence suggests exposure of nicotine-containing e-cigarette aerosol to nonusers leads to systemic absorption of nicotine. However, no studies have examined acute secondhand exposures that occur in public settings. Here, we measured the serum, saliva and urine of nonusers pre- and post-exposure to nicotine via e-cigarette aerosol. Secondarily, we recorded factors affecting the exposure.Six nonusers of nicotine-containing products were exposed to secondhand aerosol from ad libitum e-cigarette use by three e-cigarette users for 2?h during two separate sessions (disposables, tank-style). Pre-exposure (baseline) and post-exposure peak levels (Cmax) of cotinine were measured in nonusers’ serum, saliva, and urine over a 6-hour follow-up, plus a saliva sample the following morning. We also measured solution consumption, nicotine concentration, and pH, along with use behavior.Baseline cotinine levels were higher than typical for the US population (median serum session one?=?0.089?ng/ml; session two?=?0.052?ng/ml). Systemic absorption of nicotine occurred in nonusers with baselines indicative of no/low tobacco exposure, but not in nonusers with elevated baselines. Median changes in cotinine for disposable exposure were 0.007?ng/ml serum, 0.033?ng/ml saliva, and 0.316?ng/mg creatinine in urine. For tank-style exposure they were 0.041?ng/ml serum, 0.060?ng/ml saliva, and 0.948?ng/mg creatinine in urine. Finally, we measured substantial differences in solution nicotine concentrations, pH, use behavior and consumption.Our data show that although exposures may vary considerably, nonusers can systemically absorb nicotine following acute exposure to secondhand e-cigarette aerosol. This can particularly affect sensitive subpopulations, such as children and women of reproductive age.     

Economic evaluation of telephone-based weight loss support for patients with knee osteoarthritis: a randomised controlled trial

Background

The prevalence of knee osteoarthritis is increasing worldwide. Obesity is an important modifiable risk factor for both the incidence and progression of knee osteoarthritis. Consequently, international guidelines recommend all patients with knee osteoarthritis who are overweight receive support to lose weight. However, few overweight patients with this condition receive care to support weight loss. Telephone-based interventions are one potential solution to provide scalable care to the many patients with knee osteoarthritis. The objective of this study is to evaluate, from a societal perspective, the cost-utility and cost-effectiveness of a telephone-based weight management and healthy lifestyle service for patients with knee osteoarthritis, who are overweight or obese.

Methods

An economic evaluation was undertaken alongside a pragmatic randomised controlled trial. Between May 19 and June 30, 2015, 120 patients with knee osteoarthritis were randomly assigned to an intervention or usual care control group in a 1:1 ratio. Participants in the intervention group received a referral to an existing non-disease specific 6-month telephone-based weight management and healthy lifestyle service. Quality-adjusted life years (QALYs) was the utility measure and knee pain intensity, disability, weight, and body mass index (BMI) were the clinical measures of effect. Costs included intervention costs, healthcare utilisation costs (healthcare services and medication use) and absenteeism costs due to knee pain. Data was collected at baseline, 6?weeks and 26?weeks. The primary cost-effectiveness analysis was performed from the societal perspective.

Results

Mean cost differences between groups (intervention minus control) were $493 (95%CI: -3513 to 5363) for healthcare costs, $-32 (95%CI: -73 to 13) for medication costs, and $125 (95%CI: -151 to 486) for absenteeism costs. The total mean difference in societal costs was $1197 (95%CI: -2887 to 6106). For QALYs and all clinical measures of effect, the probability of the intervention being cost-effective compared with usual care was less than 0.36 at all willingness-to-pay values.

Conclusions

From a societal perspective, telephone-based weight loss support, provided using an existing non-disease specific 6-month weight management and healthy lifestyle service was not cost-effective in comparison with usual care for overweight and obese patients with knee osteoarthritis.

Trial registration number

ACTRN12615000490572, registered 18th May 2015