Echocardiography can be used as an easy, inexpensive, devoid of complications and, for the most part, universally available tool for the risk stratification of patient with acute pulmonary embolism. Because of its low...Echocardiography can be used as an easy, inexpensive, devoid of complications and, for the most part, universally available tool for the risk stratification of patient with acute pulmonary embolism. Because of its low sensibility, an echocardiogram is best indicated in a patient in whom hypotension and or shock are suspected to be due to pulmonary embolism. Pertinent findings in the echocardiogram can justify the use of fibrinolytic therapy. Most common echocar-diographic findings in acute pulmonary embolism are: dilatation of the right ventricle, right ventricular dysfunction in some cases with preservation of the motility of the apex, dilatation of the inferior vena cava with lack of collapse during inspiration flattening of the interventricular septum suggesting right ventricular pressure overload and pulmonary hypertension based on the jet of tricuspid regurgitation if available.展开更多
Background and Aims:In the REALM (Randomized, Obser-vational Study of Entecavir to Assess Long-Term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Pa-tients with Chronic HBV Infection) study, 12,378 pa...Background and Aims:In the REALM (Randomized, Obser-vational Study of Entecavir to Assess Long-Term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Pa-tients with Chronic HBV Infection) study, 12,378 patients with chronic hepatitis B virus (HBV) infection received up to 10 years of randomized therapy with entecavir or another HBV nucleos(t)ide analogue. Monitored clinical outcome events (COEs) included malignant neoplasms, HBV disease progres-sion events, and deaths. An external event adjudication com-mittee (EAC) was convened to provide real-time review of reported COEs to optimize data quality, and minimize poten-tial adverse effects of the large cohort, interdisciplinary out-come assessments, geographic scope, and long duration. Methods:The EAC comprised an international group of hep-atologists and oncologists with expertise in diagnosis of tar-geted COEs. The EAC reviewed and adjudicated COEs according to prospectively defined diagnostic criteria cap-tured in the EAC charter. Operational processes, including da-ta collection and query procedures, were implemented to optimize efficiency of data recovery to maximize capture of adjudicated COEs, the primary study outcome measure. Results: A total of 1724 COEs were reported and 1465 of these events were adjudicated by the EAC as reported by the investigators (85.0% overall concordance). Concordance by COE type varied: deaths, 99.6%;hepatocellular carcino-ma (HCC), 83.3%;non-HCC malignancies, 88.0%;non-HCC HBV disease progression, 68.2%. Reasons for lack of con-cordance were most commonly lack of adequate supporting data to support an adjudicated diagnosis or evidence that the event pre-dated the study. Conclusions: The REALM EAC performed a critical role in ensuring data quality and consis-tency;EAC performance was facilitated by well-defined diag-nostic criteria, effective data capture, and efficient operational processes. Trial registration: ClinicalTrials.gov NCT00388674.展开更多
文摘Echocardiography can be used as an easy, inexpensive, devoid of complications and, for the most part, universally available tool for the risk stratification of patient with acute pulmonary embolism. Because of its low sensibility, an echocardiogram is best indicated in a patient in whom hypotension and or shock are suspected to be due to pulmonary embolism. Pertinent findings in the echocardiogram can justify the use of fibrinolytic therapy. Most common echocar-diographic findings in acute pulmonary embolism are: dilatation of the right ventricle, right ventricular dysfunction in some cases with preservation of the motility of the apex, dilatation of the inferior vena cava with lack of collapse during inspiration flattening of the interventricular septum suggesting right ventricular pressure overload and pulmonary hypertension based on the jet of tricuspid regurgitation if available.
基金This study was funded by Bristol-Myers Squibb,which designed the study,conducted statistical analyses,and provided financial support for the study.
文摘Background and Aims:In the REALM (Randomized, Obser-vational Study of Entecavir to Assess Long-Term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Pa-tients with Chronic HBV Infection) study, 12,378 patients with chronic hepatitis B virus (HBV) infection received up to 10 years of randomized therapy with entecavir or another HBV nucleos(t)ide analogue. Monitored clinical outcome events (COEs) included malignant neoplasms, HBV disease progres-sion events, and deaths. An external event adjudication com-mittee (EAC) was convened to provide real-time review of reported COEs to optimize data quality, and minimize poten-tial adverse effects of the large cohort, interdisciplinary out-come assessments, geographic scope, and long duration. Methods:The EAC comprised an international group of hep-atologists and oncologists with expertise in diagnosis of tar-geted COEs. The EAC reviewed and adjudicated COEs according to prospectively defined diagnostic criteria cap-tured in the EAC charter. Operational processes, including da-ta collection and query procedures, were implemented to optimize efficiency of data recovery to maximize capture of adjudicated COEs, the primary study outcome measure. Results: A total of 1724 COEs were reported and 1465 of these events were adjudicated by the EAC as reported by the investigators (85.0% overall concordance). Concordance by COE type varied: deaths, 99.6%;hepatocellular carcino-ma (HCC), 83.3%;non-HCC malignancies, 88.0%;non-HCC HBV disease progression, 68.2%. Reasons for lack of con-cordance were most commonly lack of adequate supporting data to support an adjudicated diagnosis or evidence that the event pre-dated the study. Conclusions: The REALM EAC performed a critical role in ensuring data quality and consis-tency;EAC performance was facilitated by well-defined diag-nostic criteria, effective data capture, and efficient operational processes. Trial registration: ClinicalTrials.gov NCT00388674.
