Field validation as a means for continual monitoring of approved test kit's fitness for purpose in the commercial market.

Testing accuracy of a chemical contaminant requires use of a testing platform that conforms to validation criteria outlined in quality literature and standards. This study explores the application of commercial field data measured by qualified analysts using a United States Department of Agriculture - Federal Grain Inspection Service approved kit for measuring fumonisin in maize to augment method validation procedures. Analysts from seven grain testing facilities were qualified in official USDA sampling, sample preparation, and testing methodology using the Charm LF-FUMQ-WETS5. A duplicate sample was tested in the Office of the Texas State Chemist (OTSC) laboratory using UPLC-MS-MS. Data were subject to four statistical techniques using continuous and categorical methodology. This approach enabled researchers to explore if a single test or multiple comparisons were best suited to assess a field kit's fitness for purpose across facility, toxin level, and year. The study concluded that a paired t-test and correlation analysis provided a quick and meaningful evaluation of kit performance. The correct placement of samples within the correct bin (violative versus non-violative) aligns well with market forces and regulatory compliance. The results of this study also provide a useful tool to assess all field kits' performance at the beginning of the harvest season and subsequent years. The combination of statistical techniques presented in this research is an important tool in assessing mycotoxin field test kits fitness for purpose and represents a key step in a continuous improvement-quality systems process meant to protect the feed and food supply.

Enhancing maize safety: the role of co-regulation as a regulatory strategy to manage fumonisin risk.

This study explores the implementation of the One Sample Strategy (OSS), a co-regulation program aimed at managing mycotoxin risk in Texas maize. Fumonisin-contaminated cereals and oilseeds that contain greater than 5 mg kg-1 of the toxin (B1, B2, and B3) are a risk for equids and rabbits, and levels greater than 60 mg kg-1 are a risk to ruminants. The OSS, previously successful in managing aflatoxin risk in Texas maize, was evaluated for its effectiveness in handling fumonisin risk in maize, specifically as it relates to ruminants. In 2017, 25 analysts across seven firms qualified to participate in the program. To ensure greater accuracy in testing, working control samples were provided to the participating OSS firms with the requirement that their results fall within +/- 20% of the target concentration. Ninety-four percent of the working controls met this specification. The capability to grind maize to the OSS prescribed particle size was met by 100% of participants. To verify testing accuracy, file samples collected from each OSS firm were analysed by UPLC-MS/MS. The 177 fumonisin verification samples analysed by Office of the Texas State Chemist (OTSC) were correlated (r = 0.93) with co-regulation laboratories. Results were plotted in an operating curve to depict type I and type II errors. Error analysis revealed a type I error rate of 13% and type II error rate of 2% for the 5 mg kg-1 guidance level, and 6% and 8%, respectively, for the 60 mg kg-1 guidance level. For 2017, 994 official reports of analysis for fumonisin in whole maize in the Texas High Plains were issued by the seven laboratories that employed 25 OTSC-credentialed analysts. The OSS co-regulation program, supported by a quality systems approach and government regulations, has proven effective in managing fumonisin risk in Texas maize, enhancing both market confidence and livestock safety.

A preseason cardiorespiratory profile of dancers in nine professional ballet and modern companies.

While studies have investigated the physical demands of dance in terms of cardiorespiratory fitness, there are no recent comparisons of cardiorespiratory response to exercise among professional dancers of different genres. Our purpose was to: 1. develop a cardiorespiratory profile of professional dancers; 2. investigate differences in peak and recovery heart rate (HR) between professional modern and ballet dancers using an accelerated 3-minute step test; 3. demonstrate the relationship between cardiorespiratory variables; and 4. investigate the effects of company and work variables on the dancers' cardiorespiratory profiles. We hypothesized greater cardiorespiratory fitness in modern dancers than in ballet dancers, due to the nature of their repertory. Furthermore, we hypothesized that company profiles would reflect differences in work variables. Two hundred and eleven dancers (mean age 24.6 ± 4.7) from nine companies (two modern and seven ballet) performed a 3-minute step test. Demographics, height, mass, blood pressure (BP), smoking history, and resting peak and recovery HR were recorded. Body mass index (BMI) and fitness category were calculated. Independent t-tests were used to compare differences in demographics and cardiorespiratory variables due to genre, MANOVA were conducted to compare differences due to company, and correlations were calculated to determine the relationships between cardiorespiratory variables (p < 0.05). Modern dancers demonstrated higher mass and BMI, lower BP, lower resting HR and HR recovery, and a higher percentage were categorized as "fit" compared to ballet dancers (p < 0.03). There were differences between companies in age, experience, BMI, BP, resting, peak, and recovery HR, and fitness category (p < 0.001). The differences in cardiorespiratory fitness levels that may be related to rigor of repertory, rehearsal and performance seasons, or off-season exercise training are discussed. Results support the need for comprehensive physical fitness screening to identify dancers who could benefit from aerobic conditioning to enhance overall performance preparedness and to minimize fatigue effects.

Health Literacy INDEX: development, reliability, and validity of a new tool for evaluating the health literacy demands of health information materials.

There is no consensus on how best to assess the health literacy demands of health information materials. Comprehensive, reliable, and valid assessment tools are needed. The authors report on the development, refinement, and testing of Health Literacy INDEX, a new tool reflecting empirical evidence and best practices. INDEX is comprised of 63 indicators organized into 10 criteria: plain language, clear purpose, supporting graphics, user involvement, skill-based learning, audience appropriateness, user instruction, development details, evaluation methods, and strength of evidence. In a sample of 100 materials, intercoder agreement was high: 90% or better for 52% of indicators, and above 80% for nearly all others. Overall scores generated by INDEX were highly correlated with average ratings from 12 health literacy experts (r = 0.89, p < .0001). Additional research is warranted to examine the association between evaluation ratings generated by INDEX and individual understanding, behaviors, and improved health. Health Literacy INDEX is a comprehensive tool with evidence for reliability and validity that can be used to evaluate the health literacy demands of health information materials. Although improvement in health information materials is just one aspect of mitigating the effects of limited health literacy on health outcomes, it is an essential step toward a more health literate public.

Measuring exposure to health messages in community-based intervention studies: a systematic review of current practices.

Accurately measuring exposure is critical to all intervention studies. The present review examines the extent to which best practices in exposure assessment are adhered to in community-based prevention and education studies. A systematic literature review was conducted examining community-based studies testing communication interventions, published in 2003-2007. Of 663 studies identified, 54 met all inclusion criteria and were reviewed for type of exposure assessment conducted (if any), use of exposure data in study analyses, and discussion of biases related to exposure assessment. Although a majority of studies (n = 38; 70%) assessed exposure, most of these used only a simple dichotomous measure (n = 31; 82%), less than half used exposure data to adjust intervention effects (n = 16; 42%), and only six (16%) addressed selective exposure as a possible source of bias. There is substantial room for improvement in measurement and analysis of exposure to communication in community-based disease prevention studies.

A proteomics approach to cloning fenestrin from the nuclear exchange junction of tetrahymena.

We set out to find the "fenestrin" gene, a gene whose protein is associated with numerous cellular apertures, including the nuclear exchange junction in mating Tetrahymena thermophila. First we developed protocols for imaging and isolating intact nuclear exchange junctions from conjugating cells. Proteins from these junctions were purified using SDS-PAGE, subjected to limited proteolysis, and precise molecular weights were determined by mass spectrometry. Using Protein Prospector software and the published Tetrahymena Genome Database, genes for 15 of the most abundant proteins found in our extracts were identified. The most promising candidate was cloned by PCR, fused to yellow fluorescent protein (YFP), and placed under the control of an inducible metallothionein promoter. YFP-localization within live Tetrahymena transformants strongly suggested that one of these genes encoded the fenestrin protein, a result that was subsequently confirmed by Western blotting.

Migraine care among different ethnicities: do disparities exist?

OBJECTIVE: Evaluate whether, in a primary care setting, Caucasians (C) and African Americans (AA) with moderately to severely disabling migraines differed in regards to: utilizing the health-care system for migraine care, migraine diagnosis and treatment, level of mistrust in the health-care system, perceived communication with their physician, and perceived migraine triggers. BACKGROUND: Research has documented ethnic disparities in pain management. However, almost no research has been published concerning potential disparities in utilization, diagnosis, and/or treatment of migraine. It is also important to consider whether ethnic differences exist for trust and communication between patients and physicians, as these are essential when diagnosing and treating migraine. METHODS: Adult patients with headache (n = 313) were recruited from primary care waiting rooms. Of these, 131 (AA = 77; C = 54) had migraine, moderate to severe headache-related disability, and provided socioeconomic status (SES) data. Participants completed measures of migraine disability (MIDAS), migraine health-care utilization, diagnosis and treatment history, mistrust of the medical community, patient-physician communication (PPC), and migraine triggers. Analysis of covariance (controlling for SES and recruitment site), chi-square, and Pearson product moment correlations were conducted. RESULTS: African Americans were less likely to utilize the health-care setting for migraine treatment (AA = 46% vs. C = 72%, P < .001), to have been given a headache diagnosis (AA = 47% vs. C = 70%, P < .001), and to have been prescribed acute migraine medication (AA = 14% vs. C = 37%, P < .001). Migraine diagnosis was low for both groups, and <15% of all participants had been prescribed a migraine-specific medication or a migraine preventive medication despite suffering moderate to severe levels of migraine disability. African Americans had less trust in the medical community (P < .001, eta2 = 0.26) and less positive PPC (P < .001, eta2 = 0.11). Also, the lower the trust and communication, the less likely they were to have ever seen (or currently be seeing) a doctor for migraine care or to have been prescribed medication. CONCLUSIONS: Migraine utilization, diagnosis, and treatment were low for both groups. However, this was especially true for African Americans, who also reported lower levels of trust and communication with doctors relative to Caucasians. The findings highlight the need for improved physician and patient education about migraine diagnosis and treatment, the importance of cultural variation in pain presentation, and the importance of communication when diagnosing and treating migraine.