1,901 research outputs found
Balancing Academic Freedom and Professionalism: A Commentary on University Social Media Policies
Over the Counter but Under the Radar: Direct-to-Consumer Genetics Tests and FDA Regulation of Medical Devices
Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer\u27s health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.
The FDA\u27s approach to regulating genetic tests is not uniform. The FDA regulates test kits, or genetic tests developed by a manufacturer independent from the clinical laboratory that distributes them, as medical devices. These test kits are not available directly to consumers; instead, the laboratories send them to health care providers for patient diagnosis.
Absence of FDA regulation of direct-to-consumer genetic tests means that consumers utilize these tests without any assurance of their reliability, accuracy, or usefulness in helping individuals make prudent health care decisions. Furthermore, individuals often receive their test results directly from the laboratory without any formal genetic counseling regarding the meaning of these results, which are often less straightforward than consumers may expect.
This Note differentiates between test kits and home brews, identifying the hazards that direct-to-consumer genetic tests pose to the public due to the fact that they are unregulated. It also analyzes the FDA regulatory process that medical devices undergo in order to be marketed and sold. Finally, the Note advocates for FDA regulation of direct-to-consumer genetic tests as medical devices, just as test kits are, based on the protections that this regulatory process affords consumers
Socio-Economic Importance of the Boreal Forests in the Nordic Countries
This paper gives an overview of the socio-economic significance of forest resources and their utilization in the Nordic countries. The investigation covers Finland, Norway and Sweden, where coniferous forest with some birch and other broadleaved trees is the natural forest type in most areas.
From the viewpoint of national economy, the major part of the socio-economic benefits from forests comes from the large-scale forest products industry. In vast rural areas, forestry is also significant in the context of regional development.
Because of relatively strong competitiveness of the forest products industries, it is likely that the role of the Nordic countries will remain high in satisfying the world's demand for forest industry products. Timber resources as such are not a limiting factor to the expansion of forest products industries in these countries. However, nature protection and nontimber values of forest, among other factors, lower the usable potential of timber resources for industrial purposes. The most challenging task is to find a sound balance in which both the economic and environmental functions of forests can be fulfilled simultaneously
On the terms violating the custodial symmetry in multi-Higgs-doublet models
We prove that a generic multi-Higgs-doublet model (NHDM) generally must
contain terms in the potential that violate the custodial symmetry. This is
done by showing that the O(4) violating terms of the NHDM potential cannot be
excluded by imposing a symmetry on the NHDM Lagrangian. Hence we expect
higher-order corrections to necessarily introduce such terms. We also note, in
the case of custodially symmetric Higgs-quark couplings, that vacuum alignment
will lead to up-down mass degeneration; this is not true if the vacua are not
aligned.Comment: 16 pages, 1 figure. Title and abstract are modified, conclusions
remain the same. Section on Yukawa couplings is extended. Published versio
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Exploratory analysis using machine learning to predict for chest wall pain in patients with stage I non-small-cell lung cancer treated with stereotactic body radiation therapy.
Background and purposeChest wall toxicity is observed after stereotactic body radiation therapy (SBRT) for peripherally located lung tumors. We utilize machine learning algorithms to identify toxicity predictors to develop dose-volume constraints.Materials and methodsTwenty-five patient, tumor, and dosimetric features were recorded for 197 consecutive patients with Stage I NSCLC treated with SBRT, 11 of whom (5.6%) developed CTCAEv4 grade ≥2 chest wall pain. Decision tree modeling was used to determine chest wall syndrome (CWS) thresholds for individual features. Significant features were determined using independent multivariate methods. These methods incorporate out-of-bag estimation using Random forests (RF) and bootstrapping (100 iterations) using decision trees.ResultsUnivariate analysis identified rib dose to 1 cc < 4000 cGy (P = 0.01), chest wall dose to 30 cc < 1900 cGy (P = 0.035), rib Dmax < 5100 cGy (P = 0.05) and lung dose to 1000 cc < 70 cGy (P = 0.039) to be statistically significant thresholds for avoiding CWS. Subsequent multivariate analysis confirmed the importance of rib dose to 1 cc, chest wall dose to 30 cc, and rib Dmax. Using learning-curve experiments, the dataset proved to be self-consistent and provides a realistic model for CWS analysis.ConclusionsUsing machine learning algorithms in this first of its kind study, we identify robust features and cutoffs predictive for the rare clinical event of CWS. Additional data in planned subsequent multicenter studies will help increase the accuracy of multivariate analysis
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Validation and clinical implementation of an accurate Monte Carlo code for pencil beam scanning proton therapy.
Monte Carlo (MC)-based dose calculations are generally superior to analytical dose calculations (ADC) in modeling the dose distribution for proton pencil beam scanning (PBS) treatments. The purpose of this paper is to present a methodology for commissioning and validating an accurate MC code for PBS utilizing a parameterized source model, including an implementation of a range shifter, that can independently check the ADC in commercial treatment planning system (TPS) and fast Monte Carlo dose calculation in opensource platform (MCsquare). The source model parameters (including beam size, angular divergence and energy spread) and protons per MU were extracted and tuned at the nozzle exit by comparing Tool for Particle Simulation (TOPAS) simulations with a series of commissioning measurements using scintillation screen/CCD camera detector and ionization chambers. The range shifter was simulated as an independent object with geometric and material information. The MC calculation platform was validated through comprehensive measurements of single spots, field size factors (FSF) and three-dimensional dose distributions of spread-out Bragg peaks (SOBPs), both without and with the range shifter. Differences in field size factors and absolute output at various depths of SOBPs between measurement and simulation were within 2.2%, with and without a range shifter, indicating an accurate source model. TOPAS was also validated against anthropomorphic lung phantom measurements. Comparison of dose distributions and DVHs for representative liver and lung cases between independent MC and analytical dose calculations from a commercial TPS further highlights the limitations of the ADC in situations of highly heterogeneous geometries. The fast MC platform has been implemented within our clinical practice to provide additional independent dose validation/QA of the commercial ADC for patient plans. Using the independent MC, we can more efficiently commission ADC by reducing the amount of measured data required for low dose "halo" modeling, especially when a range shifter is employed
Impacts of forest bioenergy and policies on the forest sector markets in Europe - what do we know?
Assessment of parameters describing representativeness of air quality in-situ measurement sites
The atmospheric layer closest to the ground is strongly influenced by variable surface fluxes (emissions, surface deposition) and can therefore be very heterogeneous. In order to perform air quality measurements that are representative of a larger domain or a certain degree of pollution, observatories are placed away from population centres or within areas of specific population density. Sites are often categorised based on subjective criteria that are not uniformly applied by the atmospheric community within different administrative domains yielding an inconsistent global air quality picture. A novel approach for the assessment of parameters reflecting site representativeness is presented here, taking emissions, deposition and transport towards 34 sites covering Western and Central Europe into account. These parameters are directly inter-comparable among the sites and can be used to select sites that are, on average, more or less suitable for data assimilation and comparison with satellite and model data. Advection towards these sites was simulated by backward Lagrangian Particle Dispersion Modelling (LPDM) to determine the sites' average catchment areas for the year 2005 and advection times of 12, 24 and 48 h. Only variations caused by emissions and transport during these periods were considered assuming that these dominate the short-term variability of most but especially short lived trace gases. The derived parameters describing representativeness were compared between sites and a novel, uniform and observation-independent categorisation of the sites based on a clustering approach was established. Six groups of European background sites were identified ranging from <i>generally remote</i> to more polluted <i>agglomeration</i> sites. These six categories explained 50 to 80% of the inter-site variability of median mixing ratios and their standard deviation for NO<sub>2</sub> and O<sub>3</sub>, while differences between group means of the longer-lived trace gas CO were insignificant. The derived annual catchment areas strongly depended on the applied LPDM and input wind fields, the catchment settings and the year of analysis. Nevertheless, the parameters describing representativeness showed considerably less variability than the catchment geometry, supporting the applicability of the derived station categorisation
The spirit of sport: the case for criminalisation of doping in the UK
This article examines public perceptions of doping in sport, critically evaluates the effectiveness of current anti-doping sanctions and proposes the criminalisation of doping in sport in the UK as part of a growing global movement towards such criminalisation at national level. Criminalising doping is advanced on two main grounds: as a stigmatic deterrent and as a form of retributive punishment enforced through the criminal justice system. The ‘spirit of sport’ defined by the World Anti-Doping Agency (WADA) as being based on the values of ethics, health and fair-play is identified as being undermined by the ineffectiveness of existing anti-doping policy in the current climate of doping revelations, and is assessed as relevant to public perceptions and the future of sport as a whole. The harm-reductionist approach permitting the use of certain performance enhancing drugs (PEDs) is considered as an alternative to anti-doping, taking into account athlete psychology, the problems encountered in containing doping in sport through anti-doping measures and the effect of these difficulties on the ‘spirit of sport’. This approach is dismissed in favour of criminalising doping in sport based on the offence of fraud. It will be argued that the criminalisation of doping could act as a greater deterrent than existing sanctions imposed by International Federations, and, when used in conjunction with those sanctions, will raise the overall ‘price’ of doping. The revelations of corruption within the existing system of self-governance within sport have contributed to a disbelieving public and it will be argued that the criminalisation of doping in sport could assist in satisfying the public that justice is being done and in turn achieve greater belief in the truth of athletic performances
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