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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.

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   
13.

Objective

The objective of this study was to investigate the feasibility of a specific custom-made fenestrated aortic cuff in the treatment of complex abdominal aortic aneurysms (AAAs).

Methods

Between 2013 and 2016, a total of 57 custom-made Fenestrated Anaconda (Vascutek, Inchinnan, Scotland, UK) aortic cuffs were placed in 38 centers worldwide. All centers were invited to participate in this retrospective analysis. Postoperative and follow-up data included the presence of adverse events, necessity for reintervention, and renal function.

Results

Fifteen clinics participated, leading to 29 cases. Median age at operation was 74 years (interquartile range [IQR], 71-78 years); five patients were female. Two patients were treated for a para-anastomotic AAA after open AAA repair, 19 patients were treated because of a complicated course after primary endovascular AAA repair, and 8 cases were primary procedures for AAA. A total of 76 fenestrations (mean, 2.6 per case) were used. Four patients needed seven adjunctive procedures. Two patients underwent conversion, one because of a dissection of the superior mesenteric artery and one because of perforation of a renal artery. Median operation time was 225 minutes (IQR, 150-260 minutes); median blood loss, 200 mL (IQR, 100-500 mL); and median contrast volume, 150 mL (IQR, 92-260 mL). Primary technical success was achieved in 86% and secondary technical success in 93%. The 30-day morbidity was 7 of 29 with a mortality rate of 4 of 29. Estimated glomerular filtration rate remained unchanged before and after surgery (76 to 77 mL/min/m2). Between preoperative and median follow-up of 11 months, estimated glomerular filtration rate was reduced statistically significantly (76 to 63 mL/min/m2). During follow-up, 9 cases had an increase in aneurysm sac diameter (5 cases >5 mm); 14 cases had a stable or decreased aneurysm sac diameter; and in 2 cases, no aneurysm size was reported. No type I endoleak was reported, and two cases with a type III endoleak were treated by endovascular means during follow-up. Survival, reintervention-free survival, and target vessel patency at 1 year were 81% ± 8%, 75% ± 9%, and 99% ± 1%, respectively. After 2 years, these numbers were 81% ± 8%, 67% ± 11%, and 88% ± 6%, respectively. During follow-up, the two patients with a type III endoleak needed endograft-related reinterventions.

Conclusions

Treatment with this specific custom-made fenestrated aortic cuff is feasible after complicated previous (endovascular) aortic repair or in complex AAAs. The complexity of certain AAA cases is underlined in this study, and the Fenestrated Anaconda aortic cuff is a valid option in selected cases in which few treatment options are left.  相似文献   
14.

Objective

Patient selection for open lower extremity revascularization in patients with chronic kidney disease (CKD) remains a clinical challenge. This study investigates the impact of CKD on early graft failure, postoperative complications, and mortality in patients undergoing lower extremity bypass for critical limb ischemia.

Methods

The National Surgical Quality Improvement Program database was queried for all patients with critical limb ischemia from 2012 to 2015 who underwent lower extremity bypass using the targeted vascular set. The glomerular filtration rate was calculated using the Chronic Kidney Disease Epidemiology Collaboration Study equation. CKD categories were determined from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative staging criteria. Patients were classified into three groups: CKD stages 3 or lower (mild to moderate CKD), CKD stages 4 or 5 (severe CKD), and on hemodialysis (HD). Multiple variable analysis was used to examine graft failure, mortality, and postoperative complications.

Results

The Surgical Quality Improvement Program database identified 6978 patients who underwent infrainguinal lower extremity arterial bypass during the study period. There were 6101 patients (87.4%) with mild to moderate CKD, 327 (4.7%) with severe CKD, and 550 (7.9%) on HD. Patients with severe CKD and on HD were more likely to have revascularization for tissue loss (54.9% vs 68.8% and 74.7%; P < .01). Patients with severe CKD and those on HD had higher rates of early graft failure, postoperative myocardial infarction, and rates of reoperation. Multiple variable analysis confirmed these results showing that HD was associated with postoperative myocardial infarction, readmission, and increased mortality. It also demonstrated that severe CKD was associated with graft failure (odds ratio [OR], 1.67; 95% confidence interval [CI], 1.12-2.50; P = .01), postoperative myocardial infarction (OR, 2.16; 95% CI, 1.35-3.45; P < .01), and readmission (OR, 1.38; 95% CI, 1.06-1.80; P = .02). Other factors associated with graft failure include functional status (OR, 1.39; 95% CI, 1.08-1.80; P = .01), African American race (OR, 1.72; 95% CI, 1.39-2.13; P < .01), and distal bypass (OR, 1.33; 95% CI, 1.09-1.61; P < .01).

Conclusions

CKD is a significant predictor of perioperative morbidity after lower extremity bypass. Patients with severe CKD have worse postoperative outcomes without increased mortality. Those on HD have worse survival and postoperative outcomes.  相似文献   
15.

Background

Epidemiology of patients with worsening heart failure and reduced ejection fraction (HFrEF) in the real-world setting is not well described.

Objectives

The purpose of this study was to describe incidence, clinical characteristics, treatment, and outcomes of patients with HFrEF who develop worsening heart failure (HF) in the real-world setting.

Methods

Data on patients with incident HFrEF from the National Cardiovascular Data Registry PINNACLE were linked to pharmacy, private practitioner, and hospital claims databases. Incidence, clinical characteristics, treatment (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, beta-blocker, and mineralocorticoid receptor antagonist) and outcomes of patients with worsening HF, defined as ≥90 days of stable HF with subsequent worsening requiring intravenous diuretic agents, were assessed.

Results

Of 11,064 HFrEF patients, 1,851 (17%) developed worsening HF on average 1.5 years following initial HF diagnosis. Patients who developed worsening HF were more likely to be African American, be octogenarians, and have higher comorbidity burden (p < 0.001). At the onset of worsening HF, 42.4% of patients were on monotherapy, 43.4% were on dual therapy, and 14.1% were on triple therapy. A total of 48%, 61%, and 98% of patients were on >50% target dose for angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, beta-blocker, and mineralocorticoid receptor antagonist, respectively. The 2-year mortality rate was 22.5%, and 56% of patients were rehospitalized within 30 days of the worsening HF event.

Conclusions

In the real-world setting, 1 in 6 patients with HFrEF develop worsening HF within 18 months of HF diagnosis. These patients have a high risk for 2-year mortality and recurrent HF hospitalizations. The use of standard-of-care therapies both before and after the onset of worsening HF is low. With high unmet medical need, patients with worsening HF require novel treatment strategies as well as greater optimization of existing guideline-directed therapy.  相似文献   
16.
17.
18.
19.
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   
20.
ABSTRACT

This study focused on factors associated with antiretroviral therapy (ART) adherence and quality of life among transgenderwomen in Sao Paulo, Brazil, using univariable and adjusted analysis. Adherence was evaluated with a self-report tool and with HIV viral load (VL) measurement. PROQOL-HIV was used to assess quality of life. 106 TGW with median 41 years old were included; most were white (56%) and had >10 years of education (57%). Median time since HIV/AIDS diagnosis was 10 years. Overall, participants had high T CD4+ counts (median 659 cells/mm3) and most (75%) had undetectable HIV VL. 85% were considered adherent using self-report (95%CI 77-91), whereas 72% (95%CI 62-80) were considered adherent when self-report and undetectable HIV VL were analyzed jointly. Older age was associated with higher ART adherence; each year increase in age was associated with 5% higher odds of adherence (p?=?0.021). Quality of life ranged from good-excellent in 5 of 8 domains. Younger age, lower education, higher time since HIV diagnosis, comorbidities, illicit drugs use and depression were associated with lower PROQOL scores in specific domains in univariable analysis, while depression was also associated with lower total PROQOL score even after adjustment for age, comorbidities and time since HIV diagnosis (p?=?0.048).  相似文献   
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