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Latest & greatest articles for adverse events
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Risk Factors for AdverseEvents in Emergency Department Procedural Sedation for Children 28828486 2017 08 22 2017 10 06 2017 10 06 2168-6211 171 10 2017 Oct 01 JAMA pediatrics JAMA Pediatr Risk Factors for AdverseEvents in Emergency Department Procedural Sedation for Children. 957-964 10.1001/jamapediatrics.2017.2135 Procedural sedation for children undergoing painful procedures is standard practice in emergency departments worldwide. Previous studies of emergency department sedation (...) are limited by their single-center design and are underpowered to identify risk factors for serious adverseevents (SAEs), thereby limiting their influence on sedation practice and patient outcomes. To examine the incidence and risk factors associated with sedation-related SAEs. This prospective, multicenter, observational cohort study was conducted in 6 pediatric emergency departments in Canada between July 10, 2010, and February 28, 2015. Children 18 years or younger who received sedation for a painful
Adverseevents associated with medium- and long-term use of opioids for chronic non-cancer pain: an overview of Cochrane Reviews. BACKGROUND: Chronic pain is common and can be challenging to manage. Despite increased utilisation of opioids, the safety and efficacy of long-term use of these compounds for chronic non-cancer pain (CNCP) remains controversial. This overview of Cochrane Reviews complements the overview entitled 'High-dose opioids for chronic non-cancer pain: an overview of Cochrane (...) Reviews'. OBJECTIVES: To provide an overview of the occurrence and nature of adverseevents associated with any opioid agent (any dose, frequency, or route of administration) used on a medium- or long-term basis for the treatment of CNCP in adults. METHODS: We searched the Cochrane Database of Systematic Reviews (the Cochrane Library) Issue 3, 2017 on 8 March 2017 to identify all Cochrane Reviews of studies of medium- or long-term opioid use (2 weeks or more) for CNCP in adults aged 18 and over. We
Effect of Transfusion on Mortality and Other AdverseEvents Among Critically Ill Septic Patients: An Observational Study Using a Marginal Structural Cox Model 28906284 2017 09 14 2017 09 14 1530-0293 2017 Sep 12 Critical care medicine Crit. Care Med. Effect of Transfusion on Mortality and Other AdverseEvents Among Critically Ill Septic Patients: An Observational Study Using a Marginal Structural Cox Model. 10.1097/CCM.0000000000002688 RBC transfusion is often required in patients with sepsis (...) . However, adverseevents have been associated with RBC transfusion, raising safety concerns. A randomized controlled trial validated the 7 g/dL threshold, but previously transfused patients were excluded. Cohort studies led to conflicting results and did not handle time-dependent covariates and history of treatment. Additional data are thus warranted to guide patient's management. To estimate the effect of one or more RBC within 1 day on three major outcomes (mortality, ICU-acquired infections
Postmarketing AdverseEvents Related to the CardioMEMS HF System 28975249 2018 11 13 2380-6591 2 11 2017 Nov 01 JAMA cardiology JAMA Cardiol Postmarketing AdverseEvents Related to the CardioMEMS HF System. 1277-1279 10.1001/jamacardio.2017.3791 Vaduganathan Muthiah M Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. DeFilippis Ersilia M EM Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts
Association of Guideline Adherence for Serial Evaluations With Survival and Adverse Clinical Events in Patients With Asymptomatic Severe Aortic Stenosis 28877303 2018 11 13 2380-6591 2 10 2017 Oct 01 JAMA cardiology JAMA Cardiol Association of Guideline Adherence for Serial Evaluations With Survival and Adverse Clinical Events in Patients With Asymptomatic Severe Aortic Stenosis. 1141-1146 10.1001/jamacardio.2017.2952 For patients with asymptomatic severe aortic stenosis and normal left (...) and adverse clinical events, including myocardial infarction, stroke, and heart failure hospitalization, were compared between patients who adhered to serial evaluation guidance and those who did not. Medical records were reviewed from July 25, 2007, to December 6, 2012. Data analysis took place from February 4, 2017, to July 10, 2017. All-cause mortality, heart failure hospitalization, and major adverse clinical events during follow-up. The study population of 300 comprised 143 men (47.7%) and had a mean
Pharmacologic Differences of Sulfonylureas and the Risk of Adverse Cardiovascular and Hypoglycemic Events 28864502 2017 09 02 2017 09 02 1935-5548 2017 Sep 01 Diabetes care Diabetes Care Pharmacologic Differences of Sulfonylureas and the Risk of Adverse Cardiovascular and Hypoglycemic Events. dc170595 10.2337/dc17-0595 Sulfonylureas have been associated with an increased risk of cardiovascular adverseevents and hypoglycemia, but it is unclear if these risks vary with different agents. We (...) not associated with an increased risk of acute myocardial infarction (HR 0.86; CI 0.55-1.34), ischemic stroke (HR 0.92; CI 0.59-1.45), cardiovascular death (HR 1.01; CI 0.72-1.40), or all-cause mortality (HR 0.81; CI 0.66-1.003), but with an increased risk of severe hypoglycemia (HR 2.83; CI 1.64-4.88). The nonspecific, long-acting sulfonylureas glyburide and glimepiride do not have an increased risk of cardiovascular adverseevents compared with the specific, short-acting sulfonylureas gliclazide, glipizide
Late Gadolinium Enhancement by Cardiac Magnetic Resonance Imaging and Major Adverse Coronary Events "Late Gadolinium Enhancement by Cardiac Magnetic Resonance Imaging and " by Kolten Paryzek and Chase Beal < > > > > Title Author Date of Graduation Summer 8-12-2017 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies Rights . Abstract Background: Coronary artery disease is the most common type of heart disease. CAD encompasses atherosclerosis (...) of care currently involves the use electrocardiogram (ECG), computed tomography (CT), and echocardiogram in order to monitor cardiac function. A new emerging imaging study, cardiac magnetic resonance with late gadolinium enhancement, has shown to be a promising prognostic tool in evaluating patient’s risks for major adverse coronary events (MACE). CMR is a medical imaging technology for non-invasive assessment for the function and structure of the heart. Gadolinium is a contrast agent that can
Differences in Adverse Drug Events Among Pediatric Patients With and Without Cancer: Sub-Analysis of a Retrospective Cohort Study 28779391 2018 11 13 2199-1154 4 3 2017 Sep Drugs - real world outcomes Drugs Real World Outcomes Differences in Adverse Drug Events Among Pediatric Patients With and Without Cancer: Sub-Analysis of a Retrospective Cohort Study. 167-173 10.1007/s40801-017-0115-8 This study investigated the differences in the incidence and severity of adverse drug events (ADEs (...) ) in pediatric patients with and without cancer. We used data from the Japan Adverse Drug Events Study for pediatrics, a cohort study enrolling pediatric inpatients at two tertiary care teaching hospitals in Japan. ADEs were identified by on-site review of all medical charts, incident reports, and prescription queries by pharmacists. Two independent physicians reviewed all potential ADEs and classified ADEs in terms of severity and class of causative medication. We compared the incidence and characteristics
AdverseEvents With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial 28493642 2017 05 11 2017 07 14 1553-2712 2017 May 11 Academic emergency medicine : official journal of the Society for Academic Emergency Medicine Acad Emerg Med AdverseEvents With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial. 10.1111/acem.13226 The goal of our study was to compare the frequency and severity (...) of 152 patients completed the study, 76 in each arm. Compared with ketamine, ketofol determined a 22% reduction in recovery reactions incidence (p < 0.01) and less clinical and pharmacologic interventions required by these reactions. There was no serious adverseevent in both groups. Rates in hemodynamic or respiratory events as well as satisfaction scores were similar. Significantly fewer patients experienced emesis with ketofol, with a threefold reduction in incidence compared with ketamine. We
Bevacizumab for advanced cervical cancer: final overall survival and adverseevent analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). BACKGROUND: On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenesis drug bevacizumab for women with advanced cervical cancer on the basis of improved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecologic Oncology Group (GOG) 240 trial (...) . In this study, we report the prespecified final analysis of the primary objectives, OS and adverseevents. METHODS: In this randomised, controlled, open-label, phase 3 trial, we recruited patients with metastatic, persistent, or recurrent cervical carcinoma from 81 centres in the USA, Canada, and Spain. Inclusion criteria included a GOG performance status score of 0 or 1; adequate renal, hepatic, and bone marrow function; adequately anticoagulated thromboembolism; a urine protein to creatinine ratio of less
Patient-reported tolerability of adverseevents in phase 1 trials 28761740 2018 11 13 2059-7029 2 2 2017 ESMO open ESMO Open Patient-reported tolerability of adverseevents in phase 1 trials. e000148 10.1136/esmoopen-2016-000148 Phase I experts recommend revisiting dose-limiting toxicity (DLT) definition to include chronic and cumulative toxicities induced by new molecularly targeted therapies. Patient's assessment of late toxicities' tolerability is, however, unknown. A prospective survey (...) on adverseevents (AEs) tolerability on 23 National Cancer InstituteCommon Terminology Criteria for AdverseEvent, Version 4 (NCI-CTCAE.v4) items was conducted at Gustave Roussy's Phase I department. Patients' maximum tolerability duration was recorded at baseline, during trial and at trial completion. Results were compared with the corresponding physicians' survey. 52 patients enrolled in 27 Phase I trials between May 2014 and November 2015 completed 102 forms. At baseline, the most feared G2/G3 AEs
Usefulness of Multiple Biomarkers for Predicting Incident Major Adverse Cardiac Events in Patients Who Underwent Diagnostic Coronary Angiography (from the Catheter Sampled Blood Archive in Cardiovascular Diseases [CASABLANCA] Study) 28487034 2017 05 10 2017 06 12 1879-1913 120 1 2017 Jul 01 The American journal of cardiology Am. J. Cardiol. Usefulness of Multiple Biomarkers for Predicting Incident Major Adverse Cardiac Events in Patients Who Underwent Diagnostic Coronary Angiography (from (...) the Catheter Sampled Blood Archive in Cardiovascular Diseases [CASABLANCA] Study). 25-32 S0002-9149(17)30636-7 10.1016/j.amjcard.2017.03.265 We sought to develop a multiple biomarker approach for prediction of incident major adverse cardiac events (MACE; composite of cardiovascular death, myocardial infarction, and stroke) in patients referred for coronary angiography. In a 649-participant training cohort, predictors of MACE within 1 year were identified using least-angle regression; over 50 clinical
Beta-blocker subtype and risks of perioperative adverseevents following non-cardiac surgery: a nationwide cohort study 28472245 2017 05 04 2017 05 04 1522-9645 2017 May 02 European heart journal Eur. Heart J. Beta-blocker subtype and risks of perioperative adverseevents following non-cardiac surgery: a nationwide cohort study. 10.1093/eurheartj/ehx214 Beta-blockers vary in pharmacodynamics and pharmacokinetic properties. It is unknown whether specific types are associated with increased (...) perioperative risks. We evaluated perioperative risks associated with beta-blocker subtypes, overall and in patient subgroups. We performed a Danish Nationwide cohort study, 2005-2011, of patients treated chronically with beta blocker (atenolol, bisoprolol, carvedilol, metoprolol, propranolol, or other) prior to non-cardiac surgery. Risks of 30-day all-cause mortality (ACM) and 30-day major adverse cardiovascular events (MACE) were estimated using adjusted logistic regression models and odds ratios with 95
Self reported outcomes and adverseevents after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland. Objectives To assess self reported outcomes and adverseevents after self sourced medical abortion through online telemedicine. Design Population based study. Setting Republic of Ireland and Northern Ireland, where abortion is unavailable through the formal healthcare system except in a few restricted circumstances. Population 1000 (...) women who underwent self sourced medical abortion through Women on Web (WoW), an online telemedicine service, between 1 January 2010 and 31 December 2012. Main outcome measures Successful medical abortion: the proportion of women who reported ending their pregnancy without surgical intervention. Rates of adverseevents: the proportion who reported treatment for adverseevents, including receipt of antibiotics and blood transfusion, and deaths reported by family members, friends, or the authorities
Hepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus: A Review of Cases Reported to the U.S. Food and Drug Administration AdverseEvent Reporting System. Background: Direct-acting antiviral agents (DAAs) are used increasingly to treat hepatitis C virus (HCV) infection. Reports were published recently on hepatitis B virus (HBV) reactivation (HBV-R) in patients with HBV-HCV co-infection. Hepatitis B virus reactivation, defined as an abrupt (...) increase in HBV replication in patients with inactive or resolved HBV infection, may result in clinically significant hepatitis. Objective: To assess whether HBV-R is a safety concern in patients receiving HCV DAAs. Design: Descriptive case series. Setting: U.S. Food and Drug Administration (FDA) AdverseEvent Reporting System (FAERS). Patients: 29 patients with HBV-R receiving HCV DAAs. Measurements: Clinical and laboratory data. Results: The FDA identified 29 unique reports of HBV-R in patients
Radial versus femoral access in patients with acute coronary syndromes with or without ST-segment elevation: A pre-specified analysis from the randomized minimizing adverse haemorrhagic events by transradial access site and systemic implementation of angi 28329389 2017 03 22 2017 04 18 1522-9645 38 14 2017 Apr 07 European heart journal Eur. Heart J. Radial versus femoral access in patients with acute coronary syndromes with or without ST-segment elevation. 1069-1080 10.1093/eurheartj/ehx048 (...) To assess whether radial compared with femoral access is associated with consistent outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS). In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) programme patients were randomized to radial or femoral access, stratified by STEMI (2001 radial, 2009 femoral) and NSTE-ACS (2196 radial, 2198 femoral). The 30
Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study Mayor S, Baines E, Vincent C, Lankshear A, Edwards A, Aylward M, Hogan H, Harper P, Davies J, Mamtora A, Brockbank E & Gray J Record Status (...) This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Mayor S, Baines E, Vincent C, Lankshear A, Edwards A, Aylward M, Hogan H, Harper P, Davies J, Mamtora A, Brockbank E & Gray J. Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverseevents study. Health Services and Delivery Research 2017; 5(9) Authors' objectives Despite