Development and validation of a short-term breast health measure as a supplement to screening mammography.

BACKGROUND: There is a growing body of evidence to support tears as a non-traditional biological fluid in clinical laboratory testing. In addition to the simplicity of tear fluid processing, the ability to access key cancer biomarkers in high concentrations quickly and inexpensively is significantly enhanced. Tear fluid is a dynamic environment rich in both proteomic and genomic information, making it an ideal medium for exploring the potential for biological testing modalities. METHODS: All protocols involving human subjects were reviewed and approved by the University of Arkansas IRB committee (13-11-289) prior to sample collection. Study enrollment was open to women ages 18 and over from October 30, 2017-June 19, 2019 at The Breast Center, Fayetteville, AR and Bentonville, AR. Convenience sampling was used and samples were age/sex matched, with enrollment open to individuals at any point of the breast health continuum of care. Tear samples were collected using the Schirmer strip method from 847 women. Concentration of selected tear proteins were evaluated using standard sandwich ELISA techniques and the resulting data, combined with demographic and clinical covariates, was analyzed using logistic regression analysis to build a model for classification of samples. RESULTS: Logistic regression analysis produced three models, which were then evaluated on cases and controls at two diagnostic thresholds and resulted in sensitivity ranging from 52 to 90% and specificity from 31 to 79%. Sensitivity and specificity variation is dependent on the model being evaluated as well as the selected diagnostic threshold providing avenues for assay optimization. CONCLUSIONS AND RELEVANCE: The work presented here builds on previous studies focused on biomarker identification in tear samples. Here we show successful early classification of samples using two proteins and minimal clinical covariates.

Environmental Exposure to Dioxins, Dibenzofurans, Bisphenol A, and Phthalates in Children with and without Autism Spectrum Disorder Living near the Gulf of Mexico.

Environmental exposure to organic endocrine disrupting chemicals, including dioxins, dibenzofurans, bisphenol A (BPA), and phthalates has been associated with neurodevelopmental disorders, including autism spectrum disorder (ASD). We conducted a pilot monitoring study of 30 ASD cases and 10 typically developing (TD) controls ages 2-8 years from communities along the Gulf of Mexico near Alabama, which houses 14 Superfund sites, to assess the concentrations of dioxins and dibenzofurans in serum, and BPA and phthalate ester metabolites in urine. Based on General Linear Models, the lipid- or creatinine-adjusted geometric mean concentrations of the aforementioned chemicals did not differ between the ASD case and TD control groups (all p ≥ 0.27). We compared our findings to the adjusted means as reported by the National Health and Nutrition Examination Survey, survey years 2011-2012, and found that TD controls in our study had lower BPA (59%) and MEHHP (26%) concentrations, higher MBP (50%) concentration, and comparable (<20% difference) MEP, MBZP, MEOHP, and MCPP concentrations. We also conducted a preliminary investigation of dietary exposures and found that the consumption of certain types of fish may be associated with higher OCDD concentrations, and the consumption of soft drinks and juices may be associated with lower BPA and MEOHP concentrations, respectively.

Not Just Guess Work: Tips for Observation, Brainstorming, and Prototyping.

Much has been written about brainstorming and prototyping in medical devices. These 2 topics are the crucial ingredients to innovation; which, if well seeded by organized and structured forays into each, will net much higher quality and more valuable results. Structure and process, although slightly counterintuitive as applied to brainstorming and prototyping, can greatly improve the value proposition of the innovation itself.

Preventing Peer Violence Against Children: Methods and Baseline Data of a Cluster Randomized Controlled Trial in Pakistan.

BACKGROUND: Violence against and among children is a global public health problem that annually affects 50% of youth worldwide with major impacts on child development, education, and health including increased probability of major causes of morbidity and mortality in adulthood. It is also associated with the experience of and perpetration of later violence against women. The aim of this article is to describe the intervention, study design, methods, and baseline findings of a cluster randomized controlled trial underway in Pakistan to evaluate a school-based play intervention aiming to reduce peer violence and enhance mental health. METHODS: A cluster randomized controlled design is being conducted with boys and girls in grade 6 in 40 schools in Hyderabad, Pakistan, over a period of 2 years. The Multidimensional Peer-Victimization and Peer Perpetration Scales and the Children's Depression Inventory 2 (CDI 2) are being used to measure the primary outcomes while investigator-derived scales are being used to assess domestic violence within the family. Specifics of the intervention, field logistics, ethical, and fidelity management issues employed to test the program's impact on school age youth in a volatile and politically unstable country form this report. BASELINE RESULTS: A total of 1,752 school-age youth were enrolled and interviewed at baseline. Over the preceding 4 weeks, 94% of the boys and 85% of the girls reported 1 or more occurrences of victimization, and 85% of the boys and 66% of the girls reported 1 or more acts of perpetration. Boys reported more depression compared with girls, as well as higher negative mood and self-esteem scores and more interpersonal and emotional problems. INTERPRETATION: Globally, prevalence of youth violence perpetration and victimization is high and associated with poor physical and emotional health. Applying a randomized controlled design to evaluate a peer violence prevention program built on a firm infrastructure and that is ready for scale-up and sustainability will make an important contribution to identifying evidence-informed interventions that can reduce youth victimization and perpetration.

Mechanical characterization of thin film, water-based polymer gels through simple tension testing of laminated bilayers.

We present a method of characterizing the nonlinear stress-strain behavior of thin films of extremely soft, water-based polymer gels using uniaxial tension testing of bilayer laminates, in conjunction with methods of membrane nonlinear elasticity. A custom tensile testing apparatus is used to conduct quasi-static, uniaxial extension tests of narrow strips of thin, laminated sheets of bonded hydrogel and silicone rubber, submerged in a saline bath. The tensile load is measured via sensitive load cell and the position of material markers, at a central test-section of the sample, is optically tracked via digital image tracking methods. Stress-strain relationships are calculated for the hydrogel component of the bilayer, considered hyperelastic, homogeneous, isotropic, and incompressible, using membrane theories of finite hyperelasticity. We present the stress response for strains up to about 35% for poly(ethylene glycol) (PEG)-based hydrogels (>90% water) with polymer concentrations by weight of 5% to 10%. Polynomial functions are fit to the data for each formulation, whereby the one-dimensional strain-energy function for each formulation is determined by taking the indefinite integral.