Unlike ventilator allocation, provision of CPR to patients cannot be practically adjudicated by a hospital-level triage team. How does the surge of patients with Covid-19 complicate standard CPR ...practices, and how can we best design crisis standards for inpatient CPR?
The article discusses a safety communication issued by the U.S. Food and Drug Administration (F.D.A.) with regards to potential cybersecurity concerns involving malicious interference with battery ...life of or essential programming functions in several pacemaker models made by St Jude Medical. Some of the practical considerations to be kept in mind in these cases are highlighted.
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available ...that identify strengths and weakness of the approaches to medical device regulation in these settings.
We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys.
Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.
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Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Objectives The aim of this study was to examine the effect of continuous positive airway pressure (CPAP) therapy on atrial fibrillation (AF) recurrence in patients with obstructive sleep apnea (OSA) ...undergoing pulmonary vein isolation (PVI). Background OSA is a predictor of AF recurrence following PVI. However, the impact of CPAP therapy on PVI outcome in patients with OSA is poorly known. Methods Among 426 patients who underwent PVI between 2007 and 2010, 62 patients had a polysomnography-confirmed diagnosis of OSA. While 32 patients were “CPAP users” the remaining 30 patients were “CPAP nonusers.” The recurrence of any atrial tachyarrhythmia, use of antiarrhythmic drugs, and need for repeat ablations were compared between the groups during a follow-up period of 12 months. Additionally, the outcome of patients with OSA was compared to a group of patients from the same PVI cohort without OSA. Results CPAP therapy resulted in higher AF-free survival rate (71.9% vs. 36.7%; p = 0.01) and AF-free survival off antiarrhythmic drugs or repeat ablation following PVI (65.6% vs. 33.3%; p = 0.02). AF recurrence rate of CPAP-treated patients was similar to a group of patients without OSA (HR: 0.7, p = 0.46). AF recurrence following PVI in CPAP nonuser patients was significantly higher (HR: 2.4, p < 0.02) and similar to that of OSA patients managed medically without ablation (HR: 2.1, p = 0.68). Conclusions CPAP is an important therapy in OSA patients undergoing PVI that improves arrhythmia free survival. PVI offers limited value to OSA patients not treated with CPAP.
White fat stores excess energy, whereas brown and beige fat are thermogenic and dissipate energy as heat. Thermogenic adipose tissues markedly improve glucose and lipid homeostasis in mouse models, ...although the extent to which brown adipose tissue (BAT) influences metabolic and cardiovascular disease in humans is unclear
. Here we retrospectively categorized 134,529
F-fluorodeoxyglucose positron emission tomography-computed tomography scans from 52,487 patients, by presence or absence of BAT, and used propensity score matching to assemble a study cohort. Scans in the study population were initially conducted for indications related to cancer diagnosis, treatment or surveillance, without previous stimulation. We report that individuals with BAT had lower prevalences of cardiometabolic diseases, and the presence of BAT was independently correlated with lower odds of type 2 diabetes, dyslipidemia, coronary artery disease, cerebrovascular disease, congestive heart failure and hypertension. These findings were supported by improved blood glucose, triglyceride and high-density lipoprotein values. The beneficial effects of BAT were more pronounced in individuals with overweight or obesity, indicating that BAT might play a role in mitigating the deleterious effects of obesity. Taken together, our findings highlight a potential role for BAT in promoting cardiometabolic health.
•Homeowner association clauses can create barriers to sustainability.•The most prevalent barriers in clauses are large home size requirements.•Few sustainable clauses were found in Midwest ...homeowner’s associations.•Homeowner associations could use sustainable clauses to meet neighborhood goals.
Homeowner’s Associations (HOAs) are an increasingly prominent form of residential governance which use codes, covenants, and restrictions (CCRs) to govern the ways that HOA homes are designed and constructed as well as homeowners’ behaviors related to landscaping and energy use. We explore whether HOA CCRs in a highly suburban Midwest county may promote or prohibit sustainable residential development. Through content analysis, our findings suggest that HOAs rarely use their CCRs to promote sustainable development and more often create barriers through clauses related to home structure, landscaping, and energy use. Structural and landscaping clauses were most common with 81% of CCRs specifying a minimum home size and 58% of CCRS including landscaping restrictions on brush piles. Energy related clauses were less common, although alternative energy production was prohibited in 32% of sampled CCRs. Few CCRs included environmentally friendly clauses; 29% had outdoor light wattage restrictions and 19% required maintaining trees. While HOA CCRs more often present barriers, we end by discussing several constraints to and opportunities for HOAs to serve as bridges to more sustainable residential development.
As the use of remote patient monitoring services grows — driven by health care limitations imposed by the Covid-19 pandemic — clinicians, payers, and patients face important questions regarding the ...volume, value, and appropriate use of this care model.
Agent-based models (ABMs) have been widely used to study socioecological systems. They are useful for studying such systems because of their ability to incorporate micro-level behaviors among ...interacting agents, and to understand emergent phenomena due to these interactions. However, ABMs are inherently stochastic and require proper handling of uncertainty. We propose a simulation framework based on quantitative uncertainty and sensitivity analyses to build parsimonious ABMs that serve two purposes: exploration of the outcome space to simulate low-probability but high-consequence events that may have significant policy implications, and explanation of model behavior to describe the system with higher accuracy. The proposed framework is applied to the problem of modeling farmland conservation resulting in land use change. We employ output variance decomposition based on quasi-random sampling of the input space and perform three computational experiments. First, we perform uncertainty analysis to improve model legitimacy, where the distribution of results informs us about the expected value that can be validated against independent data, and provides information on the variance around this mean as well as the extreme results. In our last two computational experiments, we employ sensitivity analysis to produce two simpler versions of the ABM. First, input space is reduced only to inputs that produced the variance of the initial ABM, resulting in a model with output distribution similar to the initial model. Second, we refine the value of the most influential input, producing a model that maintains the mean of the output of initial ABM but with less spread. These simplifications can be used to 1) efficiently explore model outcomes, including outliers that may be important considerations in the design of robust policies, and 2) conduct explanatory analysis that exposes the smallest number of inputs influencing the steady state of the modeled system.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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