Abstract Background Radical cystectomy is the gold-standard management for muscle-invasive bladder cancer, and there is debate concerning the comparative effectiveness of robotic-assisted (RARC) ...versus open radical cystectomy (ORC). Objective To compare utilization, perioperative, cost, and survival outcomes of RARC versus ORC. Design, setting, and participants We identified bladder urothelial carcinoma treated with RARC ( n = 439) or ORC ( n = 7308) during 2002–2012 using the Surveillance, Epidemiology, and End Results Program-Medicare linked data. Intervention Comparison of RARC versus ORC. Outcome measurements and statistical analysis We used propensity score matching to compare perioperative and survival outcomes, including lymph node yield, perioperative complications, and healthcare costs. Results and limitations Utilization of RARC increased from 0.7% of radical cystectomies in 2002 to 18.5% in 2012 ( p < 0.001). Women comprised 13.9% versus 18.1% ( p = 0.007) of RARC versus ORC, respectively. RARC was associated with greater lymph node yield with 41.5% versus 34.9% having ≥10 lymph nodes removed (relative risk 1.1, 95% confidence interval CI 1.01–1.22, p = 0.03) and shorter mean length of hospitalization at 10.1 (± standard deviation 7.1) d versus 11.2 (± 8.6) d ( p = 0.004). While inpatient costs were similar, RARC was associated with increased home healthcare utilization (relative risk 1.14, 95% CI 1.04–1.26, p = 0.009) and higher 30-d ( p < 0.01) and 90-d ( p < 0.01) costs. With a median follow-up of 44 mo (interquartile range 16–78), overall survival (hazard ratio 0.88, 95% CI 0.74–1.05) and cancer-specific survival (hazard ratio 0.91, 95% CI 0.66–1.26) were similar. Conclusions RARC provides equivalent perioperative and intermediate term outcomes to ORC. Additional long-term and randomized studies are needed for continued comparative effectiveness assessment of RARC versus ORC. Patient summary Our population-based US study demonstrates that robotic-assisted radical cystectomy has similar perioperative and survival outcomes albeit at higher costs.
Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the ...coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after the primary two-dose vaccine series, data are needed on the safety and efficacy of offering a third (booster) dose in persons 16 years of age or older.
In this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a third dose of the BNT162b2 vaccine or with placebo. We assessed vaccine safety and efficacy against Covid-19 starting 7 days after the third dose.
A total of 5081 participants received a third BNT162b2 dose and 5044 received placebo. The median interval between dose 2 and dose 3 was 10.8 months in the vaccine group and 10.7 months in the placebo group; the median follow-up was 2.5 months. Local and systemic reactogenicity events from the third dose were generally of low grade. No new safety signals were identified, and no cases of myocarditis or pericarditis were reported. Among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated, Covid-19 with onset at least 7 days after dose 3 was observed in 6 participants in the vaccine group and in 123 participants in the placebo group, which corresponded to a relative vaccine efficacy of 95.3% (95% confidence interval, 89.5 to 98.3).
A third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against Covid-19 as compared with two doses of the BNT162b2 vaccine during a median follow-up of 2.5 months. (Funded by BioNTech and Pfizer; C4591031 ClinicalTrials.gov number, NCT04955626.).
Abstract
The zero-age main sequence (ZAMS) is a critical phase for stellar angular momentum evolution, as stars transition from contraction-dominated spin-up to magnetic wind-dominated spin-down. We ...present the first robust observational constraints on rotation for FGK stars at ≈40 Myr. We have analyzed TESS light curves for 1410 members of five young open clusters with ages between 25 and 55 Myr: IC 2391, IC 2602, NGC 2451A, NGC 2547, and Collinder 135. In total, we measure 868 rotation periods, including 96 new, high-quality periods for stars around 1
M
⊙
. This is an increase of ten times the existing literature sample at the ZAMS. We then use the
τ
2
method to compare our data to models for stellar angular momentum evolution. Although the ages derived from these rotation models do not match isochronal ages, we show that these observations can clearly discriminate between different models for stellar wind torques. Finally,
τ
2
fits indicate that magnetic braking and/or internal angular momentum transport significantly impact rotational evolution even on the pre-main sequence.
Study objective Laboratory evidence indicates that progesterone has potent neuroprotective effects. We conducted a pilot clinical trial to assess the safety and potential benefit of administering ...progesterone to patients with acute traumatic brain injury. Methods This phase II, randomized, double-blind, placebo-controlled trial was conducted at an urban Level I trauma center. One hundred adult trauma patients who arrived within 11 hours of injury with a postresuscitation Glasgow Coma Scale score of 4 to 12 were enrolled with proxy consent. Subjects were randomized on a 4:1 basis to receive either intravenous progesterone or placebo. Blinded observers assessed patients daily for the occurrence of adverse events and signs of recovery. Neurologic outcome was assessed 30 days postinjury. The primary safety measures were differences in adverse event rates and 30-day mortality. The primary measure of benefit was the dichotomized Glasgow Outcome Scale–Extended 30 days postinjury. Results Seventy-seven patients received progesterone; 23 received placebo. The groups had similar demographic and clinical characteristics. Laboratory and physiologic characteristics were similar at enrollment and throughout treatment. No serious adverse events were attributed to progesterone. Adverse and serious adverse event rates were similar in both groups, except that patients randomized to progesterone had a lower 30-day mortality rate than controls (rate ratio 0.43; 95% confidence interval 0.18 to 0.99). Thirty days postinjury, the majority of severe traumatic brain injury survivors in both groups had relatively poor Glasgow Outcome Scale–Extended and Disability Rating Scale scores. However, moderate traumatic brain injury survivors who received progesterone were more likely to have a moderate to good outcome than those randomized to placebo. Conclusion In this small study, progesterone caused no discernible harm and showed possible signs of benefit.
Left atrial appendage closure with the WATCHMAN device is an alternative to anticoagulation for stroke prevention in selected patients with atrial fibrillation (AF). LA device-related thrombus (DRT) ...is poorly defined and understood. We aimed to (1) develop consensus echocardiographic diagnostic criteria for DRT; (2) estimate the incidence of DRT; and (3) determine clinical event rates in patients with DRT. In phase 1 (training), a training manual was developed and reviewed by 3 echocardiographers with left atrial appendage closure device experience. All available transesophageal (TEE) studies in the WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation (PROTECT-AF) trial patients with suspected DRT were reviewed in 2 subsequent phases. In phase 2 (primary blind read), each reviewer independently scored each study for DRT, and final echo criteria were developed. Unanimously scored studies were considered adjudicated, whereas all others were reevaluated by all reviewers in phase 3 (group adjudication read). DRT was suspected in 35 of 485 patients by the site investigator, the echocardiography core laboratory, or both; 93 of the individual TEE studies were available for review. In phase 2, 3 readers agreed on 67 (72%) of time points. Based on phases 1 and 2, 5 DRT criteria were developed. In phase 3, studies without agreement in phase 2 were adjudicated using these criteria. Overall, at least 1 TEE was DRT positive in 27 (5.7%) PROTECT-AF patients. Stroke, peripheral embolism, or cardiac/unexplained death occurred in subjects with DRT at a rate of 3.4 per 100 patient-years follow-up. In conclusion, DRT were identified on at least 1 TEE in 27 PROTECT-AF patients, indicating a DRT incidence of 5.7%. Primary efficacy events in patients with DRT occurred at a rate of 3.4 per 100 patient-years follow-up, intermediate in frequency between event rates previously reported for the overall device and warfarin arms in PROTECT-AF.
Complications of antibiotic therapy Wright, Jenny; Paauw, Douglas S
The Medical clinics of North America,
07/2013, Letnik:
97, Številka:
4
Journal Article
Recenzirano
Antibiotics have greatly changed the practice of medicine for the better. Many infections commonly treated in the outpatient setting with antibiotics (eg, urinary tract infections, streptococcal ...pharyngitis), which previously caused significant morbidity and mortality, are now typically benign. However, with antibiotic therapy come side effects, ranging in severity from mild nausea to life-threatening cytopenias. This article highlights important complications of antibiotic therapy that may be encountered by outpatient providers. Side effects by system are discussed, and a few important drug-specific complications and important drug-drug interactions highlighted.
Mindfulness has been incorporated into several treatment approaches for psychopathology. Despite the popularity of this approach, relatively few empirical investigations have examined the ...relationship between mindfulness and autonomic indicators of flexible emotion regulation, such as heart rate variability (HRV). Generalized anxiety disorder (GAD) has been associated with both low levels of mindfulness and HRV. In this investigation, we examined the relationship between HRV and mindfulness in the context of elevated generalized anxiety (GA) symptoms—an analog for GAD—by examining whether GA level moderated this relationship. HRV was collected while participants completed self-report measures of GA and trait mindfulness. GA level interacted with mindfulness in the prediction of HRV; in the high GA, but not low GA group, mindfulness was positively associated with HRV. This suggests that for individuals with high GA, mindfulness may enhance parasympathetic influences on the heart rate. We address the limitations of the current investigation and suggest avenues for future research on mindfulness-related changes in tonic and phasic HRV over time.
•We examined the relationship between mindfulness and heart rate variability (HRV).•The relationship was examined in the context of high and low generalized anxiety symptoms (GA).•In high GA, but not low GA, mindfulness was associated with higher HRV.
Roadless Space of the Conterminous United States Watts, Raymond D; Compton, Roger W; McCammon, John H ...
Science (American Association for the Advancement of Science),
05/2007, Letnik:
316, Številka:
5825
Journal Article
Recenzirano
Roads encroaching into undeveloped areas generally degrade ecological and watershed conditions and simultaneously provide access to natural resources, land parcels for development, and recreation. A ...metric of roadless space is needed for monitoring the balance between these ecological costs and societal benefits. We introduce a metric, roadless volume (RV), which is derived from the calculated distance to the nearest road. RV is useful and integrable over scales ranging from local to national. The 2.1 million cubic kilometers of RV in the conterminous United States are distributed with extreme inhomogeneity among its counties.
To identify key principles for establishing a national clinical decision support (CDS) knowledge sharing framework.
As part of an initiative by the US Office of the National Coordinator for Health IT ...(ONC) to establish a framework for national CDS knowledge sharing, key stakeholders were identified. Stakeholders' viewpoints were obtained through surveys and in-depth interviews, and findings and relevant insights were summarized. Based on these insights, key principles were formulated for establishing a national CDS knowledge sharing framework.
Nineteen key stakeholders were recruited, including six executives from electronic health record system vendors, seven executives from knowledge content producers, three executives from healthcare provider organizations, and three additional experts in clinical informatics. Based on these stakeholders' insights, five key principles were identified for effectively sharing CDS knowledge nationally. These principles are (1) prioritize and support the creation and maintenance of a national CDS knowledge sharing framework; (2) facilitate the development of high-value content and tooling, preferably in an open-source manner; (3) accelerate the development or licensing of required, pragmatic standards; (4) acknowledge and address medicolegal liability concerns; and (5) establish a self-sustaining business model.
Based on the principles identified, a roadmap for national CDS knowledge sharing was developed through the ONC's Advancing CDS initiative.
The study findings may serve as a useful guide for ongoing activities by the ONC and others to establish a national framework for sharing CDS knowledge and improving clinical care.
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