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11.

Background

Although it is known that women do not participate in trials as frequently as men, there are limited recent data examining how women recruitment has changed over time.

Methods

We conducted MEDLINE search using a validated strategy for randomized trials published in New England Journal of Medicine, Lancet, and Journal of the American Medical Association between 1986 and 2015, and included trials evaluating pharmacologic or nonpharmacologic therapies. We abstracted data on demographics, intervention type, clinical indication, and trial design characteristics, and examined their relationships with women enrollment.

Results

In total, 598 trials met inclusion criteria. Women enrollment increased significantly over time (21% between 1986 and 1990 to 33% between 2011 and 2015; Pfor trend < 0.001) and did not differ by journal or funding source. Women enrollment varied with clinical indication, comprising 37% for non–coronary artery disease vascular trials, 30% for coronary artery disease trials, 28% for heart failure trials, and 28% for arrhythmia trials (P < 0.001), which were all significantly lower than the expected proportion in disease populations (P < 0.001). Women enrollment varied with trial type (31%, 29%, and 26% for pharmacologic, device, and procedural trials, respectively; P = 0.001). These findings were corroborated using multivariable analysis. We found significant positive correlations between women enrolled, and mean age and total number of participants. Fewer women were enrolled in trials reporting statistically significant results than those who did not (P = 0.001).

Conclusions

Although enrollment of women has increased over time, it remains lower than the relative proportion in the disease population. Future studies should elucidate the reasons for persistent under-representation of women in clinical trials.  相似文献   
12.

Background and aim

The associations of long-term exposure to particulate matter <10 μm in size (PM10), nitrogen dioxide (NO2), carbon monoxide (CO), sulfur dioxide (SO2), and ozone (O3) with cardiometabolic diseases (CMD) remain uncertain in the Korean population. Therefore, we sought to examine the associations between PM10, NO2, CO, SO2, and O3 and CMD using data collected from the Korean Community Health Survey.

Methods and results

We selected 100,867 adults aged 19 years or older who had lived in the same domicile for ≥10 years and surveyed them to collect data on socioeconomic characteristics; health-related behaviors; obesity; and physician-diagnosed CMD history, including hypertension, diabetes mellitus, dyslipidemia, stroke, myocardial infarction, and ischemic heart disease. We calculated interquartile ranges for PM10, NO2, CO, SO2, and O3 from the 10 year average concentrations (2003–2012). Hypertension, diabetes mellitus, and dyslipidemia were positively associated with PM10, NO2, CO, SO2, and O3 after adjusting for confounding factors. Obesity was positively associated with PM10, NO2, SO2, and O3. On the other hand, we found no associations between stroke, myocardial infarction, and ischemic heart disease and exposure to PM10, NO2, CO, SO2, and O3 in these subjects. In subjects aged ≥65 years, the risk of dyslipidemia was markedly increased under exposure to NO2 and CO compared to subjects aged <65 years. The risk of obesity was also significantly increased under exposure to PM10 and NO2. However, sex differences in these associations were not found.

Conclusion

Long-term exposure to PM10, NO2, CO, SO2, and O3 may be a risk factor of CMD in Korean adults.  相似文献   
13.

Introduction

Physician communication impacts patient outcomes. However, communication skills, especially around difficult conversations, remain suboptimal, and there is no clear way to determine the validity of entrustment decisions. The aims of this study were to 1) describe the development of a simulation-based mastery learning (SBML) curriculum for breaking bad news (BBN) conversation skills and 2) set a defensible minimum passing standard (MPS) to ensure uniform skill acquisition among learners.

Innovation

An SBML BBN curriculum was developed for fourth-year medical students. An assessment tool was created to evaluate the acquisition of skills involved in a BBN conversation. Pilot testing was completed to confirm improvement in skill acquisition and set the MPS.

Outcomes

A BBN assessment tool containing a 15-item checklist and six scaled items was developed. Students' checklist performance improved significantly at post-test compared to baseline (mean 65.33%, SD = 12.09% vs mean 88.67%, SD = 9.45%, P < 0.001). Students were also significantly more likely to have at least a score of 4 (on a five-point scale) for the six scaled questions at post-test. The MPS was set at 80%, requiring a score of 12 items on the checklist and at least 4 of 5 for each scaled item. Using the MPS, 30% of students would require additional training after post-testing.

Comments

We developed a SBML curriculum with a comprehensive assessment of BBN skills and a defensible competency standard. Future efforts will expand the mastery model to larger cohorts and assess the impact of rigorous education on patient care outcomes.  相似文献   
14.

Purpose

The goal of this review was to summarize, analyze, and compare trials studying the efficacy of colchicine in the prevention of atrial fibrillation (AF) post-operatively (POAF) and post–catheter ablation. Ongoing studies and current guidelines are also presented and reviewed.

Methods

Published studies on the field were identified through a literature search of the PubMed and clinicaltrials.gov databases.

Findings

Four original studies regarding POAF, two original studies regarding post–catheter ablation AF, and six meta-analyses were identified. In addition, the 3 most recent guidelines/expert consensus documents were scrutinized.

Implications

AF occurs frequently after cardiac surgery (POAF) and catheter pulmonary vein isolation (postablation AF) and is associated with increased cardiovascular morbidity. A number of trials over the last few years have investigated the role of colchicine in the prevention of POAF and postablation AF targeting the local and systemic inflammatory process that leads to initiation and maintenance of AF. Available data imply that colchicine may have a preventive role in POAF and/or postablation AF. However, certain limitations of these studies underline the need for further investigation.  相似文献   
15.
16.
Objectives:To assess low dose altepase outcome and safety in comparison with a standard-dose regimen for acute ischemic stroke treatment in Egyptian patients.Materials:An observational prospective cohort non-randomized single blinded study was carried out during the period from November 2017 to December 2018. Eighty Egyptian acute ischemic stroke patients, all eligible for intravenous alteplase, were subdivided into 2 groups (40 patients in each group). Patients were thrombolysed at a dose of 0.6 mg/kg in the first group and 0.9 mg/kg in the second group. Both groups were compared in regard to safety and outcome. Safety was expressed by the rate of symptomatic intracranial hemorrhage (SICH) and 3 months mortality, while outcome was expressed by favorable outcomes at three months (modified Rankin Scale [mRS] of 0 to 2).Results:In the first group, 69.2% (n=27) achieved favorable outcomes at 90 days compared with 64.1% (n=25) in the second group (p=0.631). Ninety-day mortality was 5% (n=2) in the first group versus 2.5% (n=1) in the second group (p=0.556). Symptomatic intracranial hemorrhage was noted in 3 patients in the second group and zero patients in the first group (p=0.077).Conclusion:Low-dose alteplase could be a practical alternative for Egyptian populations with acute ischemic stroke especially in 3 to 4.5 hours window.

Cerebrovascular stroke is the second death and the seventh disability leading cause worldwide.1 Tissue-type plasminogen activator (tPA) alteplase was the first medication approved by the Food and Drug Administration (FDA) for the acute ischemic stroke (AIS) treatment on June 1996, within 3 hours of stroke onset with a recommended dose of 0.9 mg/kg (maximum 90mg).2 In 2008, the safety of using alteplase within 3 to 4.5 hours of stroke onset was approved by the Safe Implementation of Treatments in Stroke International Stroke Thrombolysis Registry (SITS -ISTR)3 and the European Cooperative Acute Stroke Study (ECASS III).4 However, thrombolytic therapy use has not been widely adopted, especially in developing countries. The restricted time window (3 to 4.5 hours), intracerebral hemorrhage (ICH) risk and the drug high cost are major obstacles preventing its broad application.5 Coagulation and fibrinolysis responses differ among different races, which increase symptomatic intracerebral hemorrhage (SICH) risk with standard-dose alteplase6 in Asian populations, many Asian neurologists considered alteplase low dose to be a better alternative for ischemic stroke treatment. Many studies had been conducted in order to prove the efficacy and safety of Alteplase low dose.7-9 One of these studies was the Japan Alteplase Clinical Trial (J-ACT) conducted by Yamaguchi et al10 According to this study, using a 0.6 mg/kg dose of intravenous recombinant tissue plasminogen activator (rtPA) in Japanese patients was safe and effective. Despite the relatively stroke high rate among Egyptian populations, 963/100,000 inhabitants, only less than 1% of stroke patients receive intravenous thrombolysis. A major reason for this is the drug cost.11,12 Low-dose regimens (0.6 mg/kg) use will lower the economic burden of thrombolytic therapy in the community and will greatly promote the implementation of this therapy in Egypt. Our study aim was to assess the outcome and safety of alteplase low dose in comparison to the standard-dose regimen in AIS treatment in Egypt.  相似文献   
17.
AimsSelf-expanding metal stents provide rapid improvement of dysphagia in oesophageal cancer but are associated with complications. The aim of the present study was to test the effectiveness of an alternative treatment of combining biodegradable stents with radiotherapy.Materials and methodsA Simon two-stage single-arm prospective phase II trial design was used to determine the efficacy of biodegradable stents plus radiotherapy in patients with dysphagia caused by oesophagus cancer who were unsuitable for radical treatment. Fourteen patients were recruited and data from 12 were included in the final analyses.ResultsFive of 12 patients met the primary end point: one stent-related patient death; four further interventions for dysphagia within 16 weeks of stenting (41.7%, 95% confidence interval 15.2–72.3%). The median time to a 10-point deterioration of quality of life was 2.7 weeks. Nine patients died within 52 weeks of registration. The median time to death from any cause was 15.0 weeks (95% confidence interval 9.6–not reached).ConclusionThe high re-intervention observed, which met the pre-defined early stopping criteria, meant that the suggested alternative treatment was not sufficiently effective to be considered for a larger scale trial design. Further work is needed to define the place of biodegradable stents in the management of malignant oesophageal strictures.  相似文献   
18.
Objectives: To compare indicators relating to aging and health among veterans and non-veterans, and identify factors associated with subjective wellbeing (SWB) of older New Zealand veterans.

Methods: Self-reported data were obtained from participants in a longitudinal cohort study of New Zealand older adults. Responses from 352 veterans and 1500 non-veterans (age range of 55–86 and gender matched) were selected as a comparison group on indicators related to health and aging. The association of these indicators with veterans’ SWB were assessed using hierarchical regression.

Results: Apart from being older, smoking more, and having more chronic conditions, veterans did not differ from non-veterans on indicators of health and wellbeing. Mental health, physical health, purpose in life, housing satisfaction, and capabilities (choice and freedom) accounted for a significant amount of variance in veterans’ SWB.

Conclusion: Our results suggest that older veterans do not differ greatly on indices of health and aging from their non-veteran peers. Results support previous findings that lower mental and physical health is associated with lower SWB for veterans. Building upon prior findings, the current results demonstrate that interventions focusing on enhancing a sense of purpose in life, supporting one's capability to achieve, and strengthening social and physical environment through social connectedness, may serve as protective factors for SWB in veterans.  相似文献   

19.
20.

Objective

The frailty index has been linked to adverse outcomes after surgical procedures. In this study, we evaluated the association between frailty index and outcomes after elective lower extremity bypass (LEB) for lower extremity ischemia.

Methods

The American College of Surgeons National Surgical Quality Improvement Program data set (2005-2012) was used to identify patients who underwent elective LEB using diagnostic and procedure Current Procedural Terminology codes. Modified frailty index (mFI) scores, derived from the Canadian Study of Health and Aging, were categorized into three groups: low, medium, and high. Association of mFI with 30-day postoperative death (POD), myocardial infarction (MI), cardiopulmonary events (CPEs), deep tissue surgical site infection (SSI), and graft failure (GF) was evaluated. Both univariate and multivariable regression analyses—adjusted for age, sex, American Society of Anesthesiologists class, body mass index, and creatinine levels—were used to assess the effect of frailty on each outcome.

Results

Of 12,677 patients (mean age, 67.7 ± 11.1 years) identified who underwent elective LEB, POD occurred in 265 (2.1% overall). Postoperative MI, SSI, CPEs, and GF occurred in 1.6%, 2.5%, 3.1%, and 4.3%, respectively. The mean mFI of the entire sample was 0.3 ± 0.1. Adjusted odds ratio for development of any morbidity in the group with the highest mFI was 1.36 (95% confidence interval, 1.08-1.72; P = .010) compared with the low frailty group. Patients with higher mFI were more likely to develop MI and CPEs but not SSI or GF. Univariate and multivariable analyses showed a significantly increased risk of POD among those in the highest mFI tertile. Female sex and age, increased American Society of Anesthesiologists class and creatinine levels, and decreased body mass index independently predicted increased mortality. The addition of categorical mFI improved models with these variables.

Conclusions

Higher mFI is independently associated with higher mortality and morbidity. Preoperative mFI assessment may be considered an additional screening tool for risk stratification among patients undergoing LEB.  相似文献   
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