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The aim of this study is to determine whether the approach used in Australia to regulate mobile medical applications (MMA) is consistent with international standards and is suitable to address the unique challenges of these technologies.
The policies of members of the International Medical Device Regulator's Forum (IMDRF) were analyzed, to determine whether these regulatory bodies address IMDRF recommendations for the clinical evaluation of software as a medical device (SaMD). Case-studies of varying types of regulated MMAs in Australia and the United States were also reviewed to determine how well the guidance in the IMDRF's SaMD: Clinical Evaluation (2017) document was operationalized.
All included jurisdictions evaluated the effectiveness of MMAs and addressed the majority of the key sub-categories recommended in the IMDRF guidance document. However, safety principles concerning information security (cybersecurity) and potential dangers of misinformation (risk-classification) were generally not addressed in either the case-studies or in the policy documents of international regulatory bodies. Australia's approach was consistent with MMA regulation conducted internationally. None of the approaches used by global regulatory bodies adequately addressed the risk of misinformation from apps and the potential for adverse clinical consequences.
The risks posed by MMAs are mainly through the information they provide and how this is used in clinical decision-making. Policy in Australia and elsewhere should be adjusted to follow the IMDRF risk-classification criteria to address potential harms from misinformation. Australian regulatory information should also be updated so the harm posed by cybersecurity and connectivity can be comprehensively evaluated.
We investigate the aggregate and distributional effects of banking spreads in an economy with informality. We build a heterogeneous agents model with incomplete markets, credit frictions, and a rich occupational choice setting, in which informality is an option for both employers and workers. The main finding is that reductions in spreads for formal firms increase wages, output, and welfare but have a deleterious impact on unemployment and inequality. Dropping spreads for informal firms lead to reduction in inequality indicators at the expense of consumption and welfare. By calibrating the model for Brazil, we also find that a hypothetical extinction of the informal sector can be harmful for poor agents, but combined with a spread reduction, it can generate strong positive effects on output and welfare.
Cystic fibrosis (CF) is the most common autosomal recessive disorder in Caucasians, occurring in one out of every 2,500–2,800 births worldwide, and is associated with a high burden of disease. In Australia, prenatal testing for CF is indicated for pregnant couples identified as carriers or when a fetus is found to have an ‘echogenic bowel’ (FEB). We aimed to determine the effectiveness of prenatal CF testing and to assess ethical dimensions. A key challenge in assessing a prenatal test is selecting appropriate endpoints to indicate clinical effectiveness.
A systematic review was conducted and a linked evidence approach was used to answer the effectiveness question. The literature on ethical considerations relating to prenatal testing was also reviewed.
No studies were identified on the direct effectiveness of prenatal CF testing or downstream consequences. Linked evidence showed good diagnostic performance with a test failure rate of 4.5 percent. Termination of pregnancy occurred in the majority of cases where two mutations were identified in a fetus of carrier parents (155/163; 95 percent), indicating testing impacts clinical management. In FEB cases with CF, termination occurred in around sixty-five percent of pregnancies. Both terminating a pregnancy and having a child with CF were associated with poor short term parental psychological outcomes. Evidence indicates prenatal testing leads to a decreased number of CF-affected births. However, ethical analyses indicated that ‘informed decisions’ should have been the primary outcome of interest.
Proper counselling prior to testing ensures that the aim of prenatal testing is informing reproductive choices in a non-directive way, rather than decreasing the number of CF-affected births (which is ethically problematic). These results suggest that for health technology assessments undertaken on contentious topics, ethical analysis should be undertaken first so appropriate endpoints are selected for the subsequent systematic review of clinical evidence and for the economic model.
Managed Entry Agreements (MEAs) enable payers to subsidize access to new medicines while addressing uncertainties. Uncertainties may relate to the criteria for decision-making articulated in decision-making frameworks. The study's aim was to determine if there was any association between the type of MEA and criteria considered during decision-making.
All medicines with MEAs listed on the Australian national subsidy scheme between 2012-2016 were identified. Data were extracted on the types of MEA and information related to the criteria considered in decision-making for each medicine and its associated indication (i.e. a medicine-indication pair [MIP]). The criteria considered in decision-making included the comparator (therapy to which it was compared), type of economic analysis, accepted value, budget impact, financial cost of supply, cost of therapy per patient, access control (such as restrictions or prior authorization), and clinical need. Associations between types of MEA and the criteria were assessed using Chi Squared test.
There were 87 MIPs, of which 56 had only financial MEAs and 31 had performance-based MEAs. Coverage with evidence development MEAs had very high incremental cost-effectiveness ratio (ICER)/quality adjusted life year (QALY) (74 percent > AUD 50,000 [USD 37,822]). Financial MEAs where performance measures were linked to reimbursement had lower ICER/QALY (13 percent > AUD 50,000 [USD 37,822]) but greater budget impact (33% > AUD 80million [USD 60.5million]) compared to simple financial MEAs. A statistically significant association (Cramer's V = 0.5, p < 0.001) was only found between performance-based MEAs and the cost of unsubsidized therapy per patient.
The main influence on the choice of performance based MEA was the provision of access to clinically important medicines with a high treatment cost for patients.
To identify and appraise existing evaluation frameworks for mobile medical applications (MMA) and determine their suitability for use in health technology assessment (HTA) of these technologies.
Systematic searches were conducted of seven bibliographic databases to identify literature published between 2008 and 2016 on MMA evaluation frameworks. Frameworks were eligible if they were used to evaluate at least one of the HTA domains of effectiveness, safety, and/or cost and cost-effectiveness of an MMA. After inclusion, the frameworks were reviewed to determine the number and extent to which other elements of an HTA were addressed by the framework.
A total of forty-five frameworks were identified that assessed MMAs. All frameworks assessed whether the app was effective. Of the thirty-four frameworks that examined safety, only seven overtly evaluated potential harms from the MMA (e.g., the impact of inaccurate information). Only one framework explicitly considered a comparator. Technology specific domains were sporadically addressed.
None of the evaluation frameworks could be used, unaltered, to guide the HTA of MMAs. To use these frameworks in HTA they would need to identify relevant comparators, improve assessments of harms and consider the ongoing effect of software updates on the safety and effectiveness of MMAs. Attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics. Implications: Existing MMA evaluation frameworks are not suitable for use in HTA. Further research is needed before an MMA evaluation framework can be developed that will adequately inform policy makers.
Research participants are entitled to many rights that may easily come into conflict. The most important ones are that researchers respect their autonomy as persons and act on the principles of beneficence, nonmaleficence, and justice. Since 2014, research subjects from numerous states in the United States of America also have a legal “right to try” that allows them, under certain circumstances, to receive experimental (i.e., preliminarily tested) interventions, including medical devices, before official approval from the United States Food and Drug Administration. In the context of experimental interventions, such as deep brain stimulation (DBS) for Alzheimer’s disease, this article argues that research participants ought never to have a legal “right to try” without a corresponding “right to be sure.” The latter refers to external epistemic justification construed in terms of reliance on reliable evidence. This article demonstrates that the mere complexity of intervention ensembles, as in the case of DBS for Alzheimer’s disease which serves as a paradigm example, illustrate how unanswered and/or unasked open questions give rise to a “combinatorial explosion” of uncertainties that require epistemic responses that no single research team alone is likely able to provide. From this assessment, several epistemic asymmetrical relations between researchers and participants are developed. By elucidating these epistemic asymmetries, this article unravels the reasons why open science, transparent exhaustive data reporting, preregistration, and continued constant critical appraisal via pre- and postpublication peer review are not scientific virtues of moral excellence but rather ordinary obligations of the scientific work routine required to increase reliability and strength of evidence.
We study randomness beyond
-randomness and its Martin-Löf type variant, which was introduced in  and further studied in . Here we focus on a class strictly between
that is given by the infinite time Turing machines (ITTMs) introduced by Hamkins and Kidder. The main results show that the randomness notions associated with this class have several desirable properties, which resemble those of classical random notions such as Martin-Löf randomness and randomness notions defined via effective descriptive set theory such as
-randomness. For instance, mutual randoms do not share information and a version of van Lambalgen’s theorem holds.
Towards these results, we prove the following analogue to a theorem of Sacks. If a real is infinite time Turing computable relative to all reals in some given set of reals with positive Lebesgue measure, then it is already infinite time Turing computable. As a technical tool towards this result, we prove facts of independent interest about random forcing over increasing unions of admissible sets, which allow efficient proofs of some classical results about hyperarithmetic sets.
Objectives: Australia relies on managed entry agreements (MEAs) for many medicines added to the national Pharmaceutical Benefits Scheme (PBS). Previous studies of Australian MEAs examined public domain documents and were not able to provide a comprehensive assessment of the types and operation of MEAs. This study used government documents approved for release to examine the implementation and administration of MEAs implemented January 2012 to May 2016.
Methods: We accessed documents for medicines with MEAs on the PBS between January 2012 and May 2016. Data were extracted on Anatomical Therapeutic Classification (ATC), type of MEA (financial, financial with outcomes, outcomes, and subcategories within each group), implementation and administration methods, source of MEA recommendation, and type of economic analysis.
Results: Of all medication indication pairs (MIPs) recommended for listing, one-third had MEAs implemented. Our study of eighty-seven MIPs had 170 MEAs in place. The Government's expert health technology assessment (HTA) committee recommended MEAs for 90 percent of the eighty-seven MIPs. A total of 81 percent of MEAs were simple financial agreements: the majority either discounts (32 percent) or reimbursement caps (43 percent). Outcome-based MEAs were least common (5 percent). Ninety-two percent of MEAs were implemented and operated through legal agreements. Approximately half of the MIPs were listed on the basis of accepted claims of cost-minimization. Forty-nine percent of medicines were in ATC L group.
Conclusion: Advice from HTA evaluations strongly influences the implementation of ways to manage uncertainties while providing access to medicines. The government relied primarily on simple financial agreements for the managed entry of medicines for which there were perceived risks.
All Dr. Katz's students admired how quickly he expressed a point, often through tidy lists. In honor of that style, I want to focus these remarks about Michael Katz and activism on four dimensions: (1) his understanding of the activist/academic tension; (2) how he advised his graduate students to wrestle with it; (3) how he engaged nonhistorians; and (4) how his work's prognosis of the prospects for social change transformed markedly in the last five years of his career.
The suitability of a single mid-season targeted selective treatment (TST) for gastrointestinal nematodes control, based on flexible average daily weight gain (ADWG) thresholds, was investigated in 23 groups of first grazing season calves. In each group, animals were weighed three times: before turnout, at mid-season and at housing. Just after the first weighing, each group was divided in two homogenous sub-groups in terms of age, breed and weight, and randomly allocated to one of two sub-groups intented for two different mid-season anthelmintic treatment strategies: (1) a treatment of all calves composing the sub-group (whole-group treatment (WT)) or (2) a targeted selective weight gain-based treatment (TST) of the animals showing an individual pre-treatment ADWG inferior to the mean pre-treatment ADWG of the corresponding WT sub-group. Anthelmintic treatment (levamisole 7.5 mg/kg BW) was performed 3 to 4 months after turnout. At housing, two parasitological parameters (the anti-Ostertagia ostertagi antibody level-Ostertagia optical density ratio (ODR) and the pepsinogen level) and a clinical parameter (the breech soiling score) were assessed at individual level in each group. Then, the high exposed groups to gastrointestinal nematode (GIN) were defined as groups for which untreated animals exhibited a mean Ostertagia ODR ⩾0.7 and among these groups, the ones characterized by high abomasal damage due to Ostertagia for which untreated animals exhibited a mean pepsinogen level ⩾2.5 U Tyr were also identified. Among TST sub-groups, the treatment ADWG thresholds varied from 338 to 941 g/day and the percentage of treated animals from 28% to 75%. Pre- and post-treatment ADWG as well as parasitological and clinical parameters measured at housing were similar between TST and WT sub-groups including the 17 high exposed groups to GIN. Within these 17 groups, the treatment allowed to significantly improve post-treatment ADWG compared with untreated animals. In the six high exposed groups showing mean pepsinogen level ⩾2.5 U Tyr, the average effect of treatment on post-treatment ADWG was the highest and estimated up to 14 kg after a grazing duration of 4 months. In contrast, in six other groups showing mean Ostertagia ODR<0.7 in untreated animals, no effect of treatment was seen suggesting an absence of production losses related to a low level of GIN infection. This study highlighted the suitability of a convenient mid-season TST strategy for first grazing season calves, based on the use of flexible thresholds of ADWG, allowing similar growth compared with a whole-group treatment while keeping a GIN population in refugia.
During the Epoch of Reionization (EoR), feedback effects reduce the efficiency of star formation process in small halos or even fully quench it. The galaxy luminosity function (LF) may then turn over at the faint-end. We analyze the number counts of z > 5 galaxies observed in the fields of four Frontier Fields (FFs) clusters and obtain constraints on the LF faint-end: for the turn-over magnitude at z ∼ 6, MUVT ≳-13.3; for the circular velocity threshold of quenching star formation process, vc* ≲ 47 km s−1. We have not yet found significant evidence of the presence of feedback effects suppressing the star formation in small galaxies.
OBJECTIVES/SPECIFIC AIMS: Focus groups are being conducted to describe and identify barriers and/or facilitators to Hispanic males’ health literacy, culture, and language related to cervical cancer prevention practices METHODS/STUDY POPULATION: A purposive convenience sample was recruited to participate in focus group sessions with English or Spanish speaking Hispanic males 21 years of age and older. Groups were segmented by age (21–29, 30–39, 40–49, and 50–65), and language (English or Spanish). Focus group discussions (n=8) were led by a bilingual/bicultural female researcher using a discussion guide that followed Zarcadoolas et al. (2005) health literacy model 6 as related to their partners’ cervical cancer screening and prevention practices. All sessions were audio-recorded and transcribed verbatim. Participants completed standardized questioners regarding demographic data and their health literacy. Qualitative content analysis was used for analyzing focus group interviews. RESULTS/ANTICIPATED RESULTS: Preliminary qualitative analysis shows the struggle Hispanic males’ face accepting cervical cancer screening for their female partners. One participant reported that it was “a clash of cultures.” A “clash of cultures” was described as a constant struggle and acceptance between science, personal knowledge, and Hispanic cultural taboos. DISCUSSION/SIGNIFICANCE OF IMPACT: Hispanic male’s health literacy, communication, language preferences, and cervical cancer risks, will further enhance the knowledge needed to design intervention measures for cancer prevention among Hispanics. Understanding the factors that contribute to the unequal burden of cervical cancer incidence and mortality among Hispanic women in South Texas is critical to prevent cervical cancer among this population.
We have constructed a computer model for simulation of point sources imaged on CCDs. An attempt has been made to ensure that the model produces “data” that mimic real data taken with two-D detectors. To be realistic, such simulations must include randomly generated noise of the appropriate type from all sources. The synthetic data are output as simple one-D integrations, as two-D radial slices, and as three-D intensity plots. Each noise source can be turned on or off so they can be studied independently as well as in combination to provide insight into the image components.
We are making accurate observations of the change in Doppler shift of stellar absorption lines. The purpose is to detect the oscillatory reflex motion due to planets orbiting stars. The scrambling of incident light by an optical fiber and the stability of wavelength calibration by a Fabry-Perot etalon provide immunity to systematic errors. Selecting several echelle diffraction orders in the vicinity of 4250–4600 A, which are imaged on a CCD, about 350 points on the profile of the stellar spectrum are sampled by successive orders of interferometric transmission through the etalon. At 4300 A each interference order is 47 milliangstroms wide and the sample points are 0.64 A apart, causing distinct, widely-spaced monochromatic images of the entrance aperture to be formed in the focal plane of the camera. Changes in Doppler shift modify the relative intensities of these images, according to the slope of the spectral profile at each point sampled. To simplify operation and enhance sensitivity, the instrument is being operated as a null-measurement accelerometer, responding only to changes in radial velocity. With an argon emission line lamp the interferometer is calibrated to two parts in 100 million; this corresponds to ± 6 meters/sec in Doppler shift. These calibrations show instrumental variations of ± 27 meters/sec on a time scale of months; observations of stars are corrected for such changes. The internal repeatability of observations of the differential Doppler shift of Arcturus (K1 IIIb; B=1.19) is ± 6 meters/sec for each exposure of 600 square meter-seconds. These exposures are obtained in 15–20 minutes with a 0.9-meter telescope. The external repeatability (day-to-day differential accuracy) of nightly averages of stellar observations is ± 20 meters/second.
A survey of K giants is being conducted to search for both short- and long-term oscillations. Our radial velocity spectrometer has a short-term precision on bright stars of 4 m/s after an exposure of 3 minutes on the CCD detector. Extensive sets of observations have been reduced for Arcturus, Pollux, and Aldebaran. Power spectra show no apparent oscillations within these data sets for frequencies between 0.15 and 2.0 mHz. However, the nightly averages over a 4 month time base show a three-fold increase in variance for Arcturus when compared to Pollux. A periodogram reveals a period of 1.844 0.005 days (or its alias of 2.174 days).
A method has been devised and tested for measuring the c-axis orientation of crystal grains in thin sections of glacier ice. The crystal orientation and grain size of ice are of great interest to glaciologists since these parameters contain information on the prior thermal and flow history of the ice. The traditional method of determining c-axis orientation involves a transmission measurement through an ice sample, a process that is time-consuming and therefore impractical for obtaining a continuous record. A reflection- or backscatter-based method could potentially be used inside boreholes, with bubbles as reflectors to avoid such drawbacks. The concept demonstration of this paper is performed on ice slices, enabling a direct comparison of accuracy with traditional methods. Measurements of the crystal orientations (θ, ϕ) in 11 grains showed an average error of ±0.8° in ϕ, with no grain error >1.4°. Measurements of θ showed an average error of ±8.2° on ten grains, with unexplained disagreement on the remaining grain. Although the technique is applied specifically to glacier ice, it should be generally applicable to any transparent birefringent polycrystalline material.
The aim of this study was to examine the various modern music genres and their effect on the utilization of medical resources with analysis and adjustment for potential confounders.
A retrospective review of patient logs from an open-air, contemporary amphitheater over a period of 10 years was performed. Variables recorded by the medical personnel for each concert included the attendance, description of the weather, and a patient log in which nature and outcome were recorded. The primary outcomes were associations of genres with the medical usage rate (MUR). Secondary outcomes investigated were the association of confounders and the influences on the level of care provided, the transport rate, and the nature of medical complaint.
A total of 2,399,864 concert attendees, of which 4,546 patients presented to venue Emergency Medical Services (EMS) during 403 concerts with an average of 11.4 patients (annual range 7.1-17.4) each concert. Of potential confounders, only the heat index ≥90°F (32.2°C) and whether the event was a festival were significant (P=.027 and .001, respectively). After adjustment, the genres with significantly increased MUR in decreasing order were: alternative rock, hip-hop/rap, modern rock, heavy metal/hard rock, and country music (P<.05). Medical complaints were significantly increased with alternative rock or when the heat index was ≥90°F (32.2°C; P<.001). Traumatic injuries were most significantly increased with alternative rock (P<.001). Alcohol or drug intoxication was significantly more common in hip-hop/rap (P<.001). Transport rates were highest with alcohol/drug intoxicated patients (P<.001), lowest with traumatic injuries (P=.004), and negatively affected by heat index ≥90°F (32.2°C; P=.008), alternative rock (P=.017), and country music (P=.033).
Alternative rock, hip-hop/rap, modern rock, heavy metal/hard rock, and country music concerts had higher levels of medical resource utilization. High heat indices and music festivals also increase the MUR. This information can assist event planners with preparation and resource utilization. Future research should focus on prospective validation of the regression equation.
Westrol MS, KoneruS, McIntyreN, Caruso AT, ArshadFH, MerlinMA. Music Genre as a Predictor of Resource Utilization at Outdoor Music Concerts. Prehosp Disaster Med. 2017;32(3):289–296.
A new instrument for high-resolution optical logging has been built and tested in Antarctica. Its purpose is to obtain records of volcanic products and other scattering features, such as bubbles and impurities, preserved in polar ice sheets, and it achieves this by using long wavelength near-infrared light that is absorbed by the ice before many scattering events occur. Longer wavelengths ensure that the return signal is composed primarily of a single or few backscattering event(s) that limit its spatial spread. The compact optical logger features no components on its body that draw power, which minimizes its size and weight. A prototype of the logger was built and tested at Siple Dome A borehole, and the results were correlated with prior optical logging profiles and records of volcanic products from collected ice core samples.
La Commission vient de subir une lourde perte en la personne de George Ellery Hale, Directeur honoraire de l’Observatoire du Mont Wilson, décédé le 21 février 1938, à l’âge de 70 ans.
L’enregistrement des phénomènes chromosphériques qui sert de base aux relevés et statistiques publiés régulièrement par divers observatoires, a été poursuivi sans changements notables depuis le dernier congrès. Le tableau reproduit dans Trans. I.A.U. 5, 59, 1935 et dans lequel sont groupés les renseignements relatifs à ces travaux d’observation courante, est donc toujours valable.