SARS-CoV-2 is the causative virus responsible for the COVID-19 pandemic. This pandemic has necessitated that all professional and elite sport is either suspended, postponed or cancelled altogether to ...minimise the risk of viral spread. As infection rates drop and quarantine restrictions are lifted, the question how athletes can safely resume competitive sport is being asked. Given the rapidly evolving knowledge base about the virus and changing governmental and public health recommendations, a precise answer to this question is fraught with complexity and nuance. Without robust data to inform policy, return-to-play (RTP) decisions are especially difficult for elite athletes on the suspicion that the COVID-19 virus could result in significant cardiorespiratory compromise in a minority of afflicted athletes. There are now consistent reports of athletes reporting persistent and residual symptoms many weeks to months after initial COVID-19 infection. These symptoms include cough, tachycardia and extreme fatigue. To support safe RTP, we provide sport and exercise medicine physicians with practical recommendations on how to exclude cardiorespiratory complications of COVID-19 in elite athletes who place high demand on their cardiorespiratory system. As new evidence emerges, guidance for a safe RTP should be updated.
With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of ...reporting of COIs among studies in major vascular surgery journals.
A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior.
A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 interquartile range, $2441-$100,551 vs $2361 interquartile range, $525-$9,699; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively).
There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.
A series of amphiphilic nitric oxide (NO)-releasing poly(amidoamine) (PAMAM) dendrimers with different exterior functionalities were synthesized by a ring-opening reaction between primary amines on ...the dendrimer and propylene oxide (PO), 1,2-epoxy-9-decene (ED), or a ratio of the two, followed by reaction with NO at 10 atm to produce N-diazeniumdiolate-modified scaffolds with a total storage of ∼1 μmol/mg. The hydrophobicity of the exterior functionality was tuned by varying the ratio of PO and ED grafted onto the dendrimers. The bactericidal efficacy of these NO-releasing vehicles against established Gram-negative Pseudomonas aeruginosa biofilms was then evaluated as a function of dendrimer exterior hydrophobicity (i.e., ratio of PO/ED), size (i.e., generation), and NO release. Both the size and exterior functionalization of dendrimer proved important to a number of parameters including dendrimer−bacteria association, NO delivery efficiency, bacteria membrane disruption, migration within the biofilm, and toxicity to mammalian cells. Although enhanced bactericidal efficacy was observed for the hydrophobic chains (e.g., ED), toxicity to L929 mouse fibroblast cells was also noted at concentrations necessary to reduce bacterial viability by 5-logs (99.999% killing). The optimal PO to ED ratios for biofilm eradication with minimal toxicity against L929 mouse fibroblast cells were 7:3 and 5:5. The study presented herein demonstrated the importance of both dendrimer size and exterior properties in determining efficacy against established biofilms without compromising biocompatibility to mammalian cells.
This study involving patients in whom hemodialysis was being initiated shows that increased levels of fibroblast growth factor 23 (FGF-23), a hormone that enhances the renal excretion of phosphate, ...appear to be independently associated with mortality. Whether FGF-23 is a potential biomarker that could guide strategies to reduce phosphorus levels in patients with chronic kidney disease remains to be established.
This study involving patients in whom hemodialysis was being initiated shows that increased levels of fibroblast growth factor 23 (FGF-23) appear to be independently associated with mortality.
Fibroblast growth factor 23 (FGF-23), a hormone that is secreted by osteoblasts, is an important regulator of phosphorus and vitamin D metabolism. It was first described as a pathogenic factor in rare hypophosphatemic syndromes in which “primary” increases in biologically active FGF-23 cause renal phosphate wasting, hypophosphatemia, inappropriately low levels of 1,25-dihydroxyvitamin D, and rickets or osteomalacia.
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In contrast, depletion of FGF-23 leads to hyperphosphatemia, excessive levels of 1,25-dihydroxyvitamin D, ectopic calcification, and early death.
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Subsequent studies highlighted the physiologic role of FGF-23 in maintaining normal serum phosphate levels despite variability in dietary phosphorus intake.
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Background Colonoscopy quality is operator-dependent. Studies assessing the effect of interventions to decrease variation in colonoscopy quality have shown inconsistent results. Since 2009, ...endoscopists at our university-affiliated, Veterans Affairs medical center have received a quarterly “report card” summarizing individual colonoscopy quality indicators as part of an ongoing quality assurance program. Objective To determine the effect of the quality report card intervention on colonoscopy performance. Design Retrospective study. Setting Tertiary-care, academic, university-affiliated, Veterans Affairs medical center in Indianapolis, Indiana. Patients Data from 6 endoscopists practicing at the Roudebush Veterans Affairs Medical Center were included. Patients were average-risk, aged 50 years or older, undergoing their first screening colonoscopy. Intervention Quarterly report card. The study time frame was July 1, 2008 to December 31, 2008 (before-intervention) and April 1, 2009 to March 31, 2011 (intervention). Main Outcome Measurements The primary outcomes were cecal intubation and adenoma detection rates (ADR), adjusted for physician, patient age, and sex. Multivariable logistic regression was performed to determine factors associated with adenoma detection. Results A total of 928 patients (male 93%, white 78%) were included (before-intervention 336; intervention 592). There were no significant differences in patient age, sex, smoking status, body mass index, bowel preparation quality, colonoscope model, and proportion of colonoscopies performed with a trainee between the before-intervention and intervention phases. In the intervention phase, the adjusted adenoma detection and cecal intubation rates were significantly higher: 53.9% (95% confidence interval CI, 49.7%-58.1%) vs 44.7% (95% CI, 39.1%-50.4%); P = .013 and 98.1% (95% CI, 96.7%-99.0%) vs 95.6% (95% CI, 92.5%-97.5%); P = .027, respectively. A higher ADR trend in the intervention phase was found for 5 of the 6 physicians. The increment in ADR was due mostly to increased detection of proximal adenomas. There were no significant changes in serrated polyp detection, advanced neoplasm detection, number of adenomas detected per colonoscopy, and mean size of adenomas after implementation of the intervention. The report card intervention remained significantly associated with higher ADRs after adjustment for patient age, sex, and physician (odds ratio 1.45; 95% CI, 1.08-1.94). Limitations Single center, small number of endoscopists. Conclusion A quarterly report card was associated with improved colonoscopy quality indicators. This intervention is practical to generate and implement and may serve as a model for quality improvement programs in different patient and physician groups.
Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The ...U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the pandemic, such as guidance documents to expand the use of digital therapeutics for psychiatric disorders and medical devices for remote patient monitoring. In this article, we contextualize these policies to the agency’s existing regulatory framework for digital health, outline key considerations for patients and health care providers, and identify implications for the future of digital health innovation.
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