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0001), history of major bleeding (OR 2.85; 95% CI, 1.96-4.14; P  less then  .0001), time since AF diagnosis (OR 1.04; 95% CI, 1.01-1.06; P  less then  .0001), concomitant vascular disease (OR 1.43; 95% CI, 1.10-1.87; P = .0008) and diabetes mellitus (OR 1.3; 95% CI, 1.02-1.65, P = .03). Patients with minor bleeding, compared with the remaining subjects scored higher on the JAKQ (median, 62.5% vs 56.2%, respectively, P  less then  .0001). The former group knew more about the purpose of anticoagulant therapy (71.8% vs 65.7%, P = .01) and bleeding as its key side effect (66.1% vs 52.7%, P  less then  .0001), and were better informed on the safest painkillers to use in combination with anticoagulation (48% vs 35%, P  less then  .0001). CONCLUSION This study suggests that AF patients who accept persistent minor bleeding have better knowledge on the disease and anticoagulation therapy compared with those free of these side effects. © 2020 John Wiley & Sons Ltd.BACKGROUND AND AIM Colonic perforation is a rare complication of colonoscopy and ranges from 0% to 1% in all patients undergoing colonoscopy. The aim of this study was to assess the time trends, risk factors, and mortality associated with colonoscopy-induced perforation (CIP) in hospitalized patients as the data are limited. METHODS Data are obtained from the Nationwide Inpatient Sample database to identify hospitalized patients between 2005 and 2014 that had CIP. Various factors like age and gender were assessed for association with CIP, followed by univariate and multivariate regression analyses. RESULTS A total of 2 651 109 patients underwent inpatient colonoscopy between 2005 and 2014, and 4567 (0.2%) of the patients had CIP. Overall, incidence of CIP has increased from 2005 to 2014 (0.1% to 0.3%) (P  65 years (OR [95% CI] of 1.35 [1.23, 1.47], 1.34 [1.17, 1.53], 1.28 [1.02, 1.62], and 1.21 [1.11, 1.33], respectively) (all P  less then  0.05). CIP group had 33% less obesity (OR [95% CI] 0.77 [0.65-0.9], P = 0.002) and 13-fold higher mortality (0.5% vs 8.1%) (P  less then  0.001) as compared to patients without CIP. The CIP-associated mortality ranged from 2% to 8% and remained stable throughout the study period. CONCLUSIONS Our study suggests that the risk of CIP was highest in elderly patients, Caucasians, those with inflammatory bowel disease, end-stage renal disease, and after polypectomy. Recognizing the factors associated with CIP may lead to informed discussion about risks and benefits of inpatient colonoscopy. © 2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.OBJECTIVES To assess the qualitative and quantitative characteristics of suspected cardiac masses by contrast-enhanced ultrasonography (CEUS) and to evaluate its usefulness. METHODS Twenty-eight adult patients with suspected cardiac masses were selected for this study. All of them were examined by conventional transthoracic echocardiography (TTE) and CEUS. The location, attachment point, basement, morphology, size, boundary, internal echo, shape change, range of motion, length, area, effect on hemodynamics, and peak enhancement of the masses (A1), and adjacent normal myocardium (A2) were measured. Then, the A1 to A2 ratio was calculated and the above parameters were analyzed. RESULTS The benign lesions showed regular morphology and clear-boundary uniform enhancement of the contrast agent. Malignant lesions showed an irregular shape, unclear boundary with surrounding tissue, and uneven enhancement of the contrast agent. The normal myocardial perfusion intensity was the same; there was no enhancement inside a simple thrombus, and the A1 of the benign lesion was lower than that of the normal myocardium (mean value [dB] ± SD, 0.63 ± 0.42); the A2 of the malignant lesion was higher than that of the normal myocardium (mean value [dB] ± SD, 1.49 ± 0.09). The difference in the ratio of A1 to A2 between groups was statistically significant (P  less then  .05). CONCLUSIONS Contrast-enhanced ultrasonography can assess the basic biological characteristics and properties of cardiac masses and has a high diagnostic accuracy for differentiation of a thrombus from a tumor or a benign tumor from a malignant tumor. © 2020 Wiley Periodicals, Inc.The average age of renal transplant recipients in the United States has increased over the past decade. The implications, however, have not been fully investigated. We explored predictors of success and demographic variables related to outcomes in elderly live donor transplantation. Retrospective analysis was performed using the UNOS database between 2001 and 2016. Donor characteristics and the graft failure rate of recipients above and below 70 years of age were compared across four eras 2001-2004, 2005-2008, 2009-2012, and 2013-2016. There was a steady increase in average donor age from the first era to the fourth era (40-44) which was more evident among the septuagenarian patients (43-50) (P 70 population. Live donation in the elderly is justified based on graft survival and patient survival. However, racial and gender differences exist in septuagenarian recipients and their donors. © 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.BACKGROUND Exposure to black carbon indoors may be associated with blood pressure; however, evidence is limited to vulnerable subpopulations and highly exposed individuals. Our objective was to explore the relationship between indoor black carbon at various exposure windows on resting blood pressure in a general population sample. METHODS Black carbon was measured in the home of 76 individuals aged 10-71 in New Orleans, Louisiana. Exposure was measured every 1 minute for up to 120 hours using an AE51 microaethalometer. Systolic blood pressure and diastolic blood pressure were measured at the conclusion of exposure monitoring. RESULTS In adjusted models, at all exposure windows, increasing black carbon was associated with increased systolic blood pressure. The period 0-72 hours prior to blood pressure measurement showed the strongest effect; a 1 μg/m3 increase in black carbon was associated with a 7.55 mm Hg (P = .02) increase in systolic blood pressure. The relationship was stronger in participants reporting doctor-diagnosed hypertension (β = 6.47 vs β = 3.27). Black carbon was not associated with diastolic blood pressure. CONCLUSION Increasing black carbon concentration indoors is positively associated with increasing systolic blood pressure with the most relevant exposure window being 0-72 hours prior to blood pressure measurement. Individuals with hypertension may be a more susceptible population. © 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.Following the release of the framework for the Real-World Evidence (RWE) Program, the US Food and Drug Administration (FDA) is actively evaluating and exploring ways to optimize the utility of real-world data (RWD) and RWE to support regulatory decision making. For rare conditions, conducting traditional randomized clinical trials may not always be feasible, and RWD and RWE have played and will continue to play an important role. We use three case examples-cerliponase alfa, asfotase alfa, and uridine triacetate-to illustrate how RWD from disease registries, medical records with chart review, and literature, respectively, have been used to generate RWE to support regulatory decisions for selected rare diseases. These examples highlight the need for improving data reliability and quality in existing data to expand use of RWD and RWE beyond "hard endpoints" and standardizing data collection for outcome measures in patient registries to expand its utility. We also discuss a recent FDA guidance for using RWE in supporting rare disease drug development, including its recommendations about using natural history studies as external control groups for single-arm interventional trials. The external control group needs to be comparable with the treated group. Selection bias and confounding are major concerns because of lack of randomization and unrecognized baseline differences. Use of valid epidemiological approaches can reduce these biases. Lastly, we discuss future directions to expand the use of RWD and RWE to support orphan drug approvals, including the need for including patient experience data as an important source of RWD. PF-3758309 cost © 2020 John Wiley & Sons Ltd.BACKGROUND The cesarean birth rate in the United States is 32%, and there is discussion about the cause of high surgical birth rates. Our purpose was to determine whether mode of birth is influenced by maternal, nurse, and system factors. METHODS Secondary analysis of a data set of 163 women having postdates labor induction with oxytocin. Kaplan-Meier survival curves were calculated to compare the time for patients to reach an infusion rate of 6 mU/min, consistent with endogenous oxytocin levels in active labor. We used the log-rank test to evaluate survival curve differences. Multiple logistic regression and Cox proportional hazards models were conducted and included covariates that had statistically significant bivariate relationships with the time variable, or were clinically meaningful. RESULTS The mean time to reach 6 mU/min was longer for women who birthed by cesarean (172.5 minutes) than for women who had vaginal birth (125.0 minutes, P = .024). The mean time to reach 6 mU/min was also longer for women admitted on night shift (147.0 minutes) than day shift (110.2 minutes, P = .018). No maternal characteristics were significantly related to the time to reach a rate of 6 mU/min. CONCLUSIONS Even during the initial hours of labor induction, it is important that the oxytocin infusion is titrated appropriately to aid women in achieving timely vaginal birth. Intrapartum nurses should receive education about the pharmacokinetics of intravenous oxytocin to understand proper administration of this high-alert medication. © 2020 Wiley Periodicals, Inc.The positive health benefits of regular exercise, particularly regarding cardiovascular risk and diseases, are well recognized and scientifically evident. However, a sedentary lifestyle is one of the most important cardiovascular risk factors that is still insufficiently addressed. Leisure time active commuting like walking and biking are an ideal way to improve exercise behavior in the general population. The purpose of this sub-study of the GISMO study was to assess dose-response relations in all commuters and the three subgroups of commuters (physically active by bicycle and/or walking, physically active by using public transportation and the controls using their own vehicles). As such, a positive dose-response relationship could be confirmed in all physically active commuters compared to the control group. Whether the commuters cycled, walked or travelled by public transportation - the more physical exercise they performed (measured in MET-hours) the larger their gain in physical fitness (measured in gained or "Delta" Watt during a maximal exercise test) and their physical fitness at the end of the study was (p = 0.016 and p = 0.003, respectively). Health-related quality of life correlated in 2 out of 8 subdomains of the SF-36 questionnaire with MET-hours achieved during the study period (General Health and Physical Functioning). No clearly significant dose-response could be observed regarding HDL-cholesterol or body composition. Our results indicate a dose-response pattern of healthy commuting in exercise capacity and health related quality of life to increase doses of physically active commuting. © 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.