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Latest & greatest articles for adverse events
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Serious adverseevents and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England. OBJECTIVES: To provide accurate risk estimates of serious adverseevents after elective shoulder replacement surgery for arthritis, including age and sex specific estimates of the lifetime risk of revision surgery. DESIGN: Population based cohort study. SETTING: Hospital episode statistics for NHS England, including civil (...) registration mortality data. PARTICIPANTS: 58 054 elective shoulder replacements in 51 895 adults (aged ≥50 years) between April 1998 and April 2017. MAIN OUTCOME MEASURES: The lifetime risk of revision surgery, calculated using an actuarial life table approach and the cumulative probability method. Rates of serious adverseevents at 30 and 90 days post-surgery: pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events
Benchmarking study helps hospitals improve measurement of adverseevents Signal - Benchmarking study helps hospitals improve measurement of adverseevents Dissemination Centre Discover Portal NIHR DC Discover Benchmarking study helps hospitals improve measurement of adverseevents Published on 20 June 2017 One in ten inpatients in Welsh hospitals experienced an adverseevent of some sort, about half of which were potentially preventable. This is very similar to the rate in other countries (...) understand how many events were preventable and the degree of harm. The two-step process found 10.3% of patients had an adverseevent, while the tool found 8% adverseevents. Hospitals which carried out more surgery had higher rates of adverseevents. Use of this trigger tool has since been dropped in Wales and a new “hybrid” system of adverseevent identification is being developed. Share your views on the research. Why was this study needed? Global estimates of rates of adverseevents range from about
Infants anaesthetised without placing a tube in the trachea have fewer adverse breathing events Signal - Infants anaesthetised without placing a tube in the trachea have fewer adverse breathing events Dissemination Centre Discover Portal NIHR DC Discover Infants anaesthetised without placing a tube in the trachea have fewer adverse breathing events Published on 11 July 2017 Adverse breathing events are about three times more common when using endotracheal tubes than laryngeal mask airways (...) fewer airway-related complications than tubes. This Australian randomised controlled trial supported this, finding an adverseevent rate of 53% with endotracheal tubes compared with only 18% with laryngeal mask airways. Conventional anaesthesia teaching advises the use of endotracheal tubes in infants even for relatively minor surgery, to provide a secure airway, but incidents may be more common when placing or removing the tube than a laryngeal mask. Share your views on the research. Why
Cannabis derivative may reduce seizures in some severe drug-resistant epilepsies, but adverseevents increase Cannabis derivative may reduce seizures in some severe drug-resistant epilepsies, but adverseevents increase Dissemination Centre Discover Portal NIHR DC Discover Cannabis derivative may reduce seizures in some severe drug-resistant epilepsies, but adverseevents increase Published on 26 June 2018 doi: In people with some types of severe, drug-resistant epilepsy, adding cannabidiol (...) ; three trials, 306 participants). The likelihood of reducing seizure frequency by 50% or more was moderately increased (43.5% with cannabidiol vs 25.0% with placebo; RR 1.74, 95% CI 1.24 to 2.43; two trials, 291 participants). Parents or carers reported an improvement in their child’s overall quality of life (59.8% with cannabidiol vs 34.5% with placebo; RR 1.73, 95% CI 1.33 to 2.26, two trials, 274 participants). Any adverseevents (88.4% with cannabidiol vs 69.7% with placebo; RR 1.24, 95% CI 1.13
Adverseevents in people taking macrolide antibiotics versus placebo for any indication. BACKGROUND: Macrolide antibiotics (macrolides) are among the most commonly prescribed antibiotics worldwide and are used for a wide range of infections. However, macrolides also expose people to the risk of adverseevents. The current understanding of adverseevents is mostly derived from observational studies, which are subject to bias because it is hard to distinguish events caused by antibiotics from (...) events caused by the diseases being treated. Because adverseevents are treatment-specific, rather than disease-specific, it is possible to increase the number of adverseevents available for analysis by combining randomised controlled trials (RCTs) of the same treatment across different diseases. OBJECTIVES: To quantify the incidences of reported adverseevents in people taking macrolide antibiotics compared to placebo for any indication. SEARCH METHODS: We searched the Cochrane Central Register
Major Adverse Cardiac Events and Mortality Associated with Electroconvulsive Therapy: A Systematic Review and Meta-analysis 30557212 2018 12 20 1528-1175 130 1 2019 Jan Anesthesiology Anesthesiology Major Adverse Cardiac Events and Mortality Associated with Electroconvulsive Therapy: A Systematic Review and Meta-analysis. 83-91 10.1097/ALN.0000000000002488 WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Cardiac events after electroconvulsive therapy have been reported sporadically (...) , but a systematic assessment of the risk is missing. The goal of this study was to obtain a robust estimate of the incidence of major adverse cardiac events in adult patients undergoing electroconvulsive therapy. Systematic review and meta-analysis of studies that investigated electroconvulsive therapy and reported major adverse cardiac events and/or mortality. Endpoints were incidence rates of major adverse cardiac events, including myocardial infarction, arrhythmia, pulmonary edema, pulmonary embolism, acute
Prognostic Accuracy of the HEART Score for Prediction of Major Adverse Cardiac Events in Patients Presenting With Chest Pain: A Systematic Review and Meta-analysis 30375097 2018 11 30 1553-2712 2018 Oct 29 Academic emergency medicine : official journal of the Society for Academic Emergency Medicine Acad Emerg Med Prognostic Accuracy of the HEART Score for Prediction of Major Adverse Cardiac Events in Patients Presenting With Chest Pain: A Systematic Review and Meta-analysis. 10.1111/acem.13649 (...) The HEART score has been proposed for emergency department (ED) prediction of major adverse cardiac events (MACE). We sought to summarize all studies assessing the prognostic accuracy of the HEART score for prediction of MACE in adult ED patients presenting with chest pain. We searched MEDLINE, PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Database of Systematic Reviews from inception through May 2018 and included studies using the HEART score for the prediction of short-term MACE in adult
Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial. Importance: Despite guideline recommendations, many patients discontinue P2Y12 inhibitor therapy earlier than the recommended 1 year after myocardial infarction (MI), and higher-potency P2Y12 inhibitors are underutilized. Cost is frequently cited as an explanation for both of these observations. Objective (...) : To determine whether removing co-payment barriers increases P2Y12 inhibitor persistence and lowers risk of major adverse cardiovascular events (MACE). Design, Setting, and Participants: Cluster randomized clinical trial among 301 hospitals enrolling adult patients with acute MI (June 5, 2015, through September 30, 2016); patients were followed up for 1 year after discharge (final date of follow-up was October 23, 2017), with blinded adjudication of MACE; choice of P2Y12 inhibitor was per clinician
Management of anlotinib-related adverseevents in patients with advanced non-small cell lung cancer: Experiences in ALTER-0303. 30666799 2019 01 22 1759-7714 2019 Jan 21 Thoracic cancer Thorac Cancer Management of anlotinib-related adverseevents in patients with advanced non-small cell lung cancer: Experiences in ALTER-0303. 10.1111/1759-7714.12977 Anlotinib is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor, fibroblast growth factor receptor, platelet (...) -derived growth factor receptor, and stem cell factor receptor (c-Kit). In the phase III ALTER-0303 trial (Clinical Trial Registry ID: NCT 02388919), anlotinib significantly improved overall survival versus placebo in advanced non-small cell lung cancer patients who had received at least two previous chemotherapy and epidermal growth factor receptor/anaplastic lymphoma kinase targeted therapy regimens. This study summarized adverseevent management in this trial. Patients were randomized (2:1
Sodium bicarb vs sodium chloride, and acetylcysteine vs placebo, did not differ for adverseevents after angiography. 29459959 2018 12 24 2018 12 24 1539-3704 168 4 2018 02 20 Annals of internal medicine Ann. Intern. Med. Sodium bicarb vs sodium chloride, and acetylcysteine vs placebo, did not differ for adverseevents after angiography. JC22 10.7326/ACPJC-2018-168-4-022 Carnicelli Anthony P AP Granger Christopher B CB eng Journal Article Comment United States Ann Intern Med 0372351 0003-4819 0
[Hydroxychloroquine to obtain pregnancy without adverse obstetrical events in primary antiphospholipid syndrome: French phase II multicenter randomized trial, HYDROSAPL]. 30041771 2018 12 11 2018 12 11 2468-7189 46 7-8 2018 Jul - Aug Gynecologie, obstetrique, fertilite & senologie Gynecol Obstet Fertil Senol [Hydroxychloroquine to obtain pregnancy without adverse obstetrical events in primary antiphospholipid syndrome: French phase II multicenter randomized trial, HYDROSAPL]. 598-604 S2468-7189 (...) (18)30178-8 10.1016/j.gofs.2018.06.008 Antiphospholipid syndrome is defined by the presence of thrombosis and/or obstetrical adverseevents (≥3 recurrent early miscarriage or fetal death or a prematurity<34 weeks of gestation) associated with persistent antiphospholipid antibodies. The pregnancy outcome has been improved by the conventional treatment (aspirin 100mg/day with low molecular weight heparin [LMWH] from 30 to 75% of uncomplicated pregnancies. In PROMISSE study, 19% of pregnancies had
Inhaled steroids with and without regular salmeterol for asthma: serious adverseevents. BACKGROUND: Epidemiological evidence has suggested a link between use of beta₂-agonists and increased asthma mortality. Much debate has surrounded possible causal links for this association, and whether regular (daily) long-acting beta₂-agonists (LABAs) are safe, particularly when used in combination with inhaled corticosteroids (ICSs). This is an update of a Cochrane Review that now includes data from two (...) large trials including 11,679 adults and 6208 children; both were mandated by the US Food and Drug Administration (FDA). OBJECTIVES: To assess risks of mortality and non-fatal serious adverseevents (SAEs) in trials that randomised participants with chronic asthma to regular salmeterol and ICS versus the same dose of ICS. SEARCH METHODS: We identified randomised trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trials registers for unpublished
In-hospital versus postdischarge major adverseevents within 30 days following lower extremity revascularization 30301689 2018 11 11 1097-6809 2018 Oct 06 Journal of vascular surgery J. Vasc. Surg. In-hospital versus postdischarge major adverseevents within 30 days following lower extremity revascularization. S0741-5214(18)31793-2 10.1016/j.jvs.2018.06.207 Studies using hospital discharge data likely underestimate postoperative morbidity and mortality after lower extremity revascularization (...) because they fail to capture postdischarge events. However, the degree of underestimation and the timing of postdischarge complications are not well-characterized. We used the American College of Surgeons National Surgical Quality Improvement Program procedure-targeted vascular databases from 2011 to 2015 to tabulate 30-day adverseevents (in hospital and after discharge) for lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) performed for claudication and chronic limb
Sodium glucose cotransporter 2 inhibitors and risk of serious adverseevents: nationwide register based cohort study. OBJECTIVE: To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverseevents of current concern. DESIGN: Register based cohort study. SETTING: Sweden and Denmark from July 2013 to December 2016. PARTICIPANTS: A propensity score matched cohort of 17 213 new users of SGLT2 inhibitors (dapagliflozin, 61%; empagliflozin (...) , 0.71 to 1.38) or acute pancreatitis (1.3 v 1.2, 1.16, 0.64 to 2.12). CONCLUSIONS: In this analysis of nationwide registers from two countries, use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation and diabetic ketoacidosis, but not with other serious adverseevents of current concern. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http
Combination of the CYP2C19 metabolizer and the GRACE risk score better predicts the long-term major adverse cardiac events in acute coronary syndrome undergoing percutaneous coronary intervention 30193195 2018 10 30 1879-2472 170 2018 10 Thrombosis research Thromb. Res. Combination of the CYP2C19 metabolizer and the GRACE risk score better predicts the long-term major adverse cardiac events in acute coronary syndrome undergoing percutaneous coronary intervention. 142-147 S0049-3848(18)30476-6 (...) 10.1016/j.thromres.2018.08.016 Both Global Registry of Acute Coronary Events (GRACE) risk score and CYP2C19 metabolizer status can independently predict major adverse cardiac events (MACEs) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). We investigated whether their combination could better predict MACE occurrence in patients with ACS undergoing PCI. This retrospective cohort study included 548 consecutive patients with ACS undergoing PCI. A
Prospective Validation of Clinical Criteria to Identify Emergency Department Patients at High Risk for Adverse Drug Events 29517818 2018 09 11 1553-2712 25 9 2018 Sep Academic emergency medicine : official journal of the Society for Academic Emergency Medicine Acad Emerg Med Prospective Validation of Clinical Criteria to Identify Emergency Department Patients at High Risk for Adverse Drug Events. 1015-1026 10.1111/acem.13407 Adverse drug events (ADEs) cause or contribute to one in nine (...) tertiary and one community hospital in Canada. We enrolled 1,529 adults presenting to EDs over 12 months. We applied two clinical decision rules and collected baseline variables prior to assessments by clinical pharmacists and physicians. We compared the physician and pharmacist diagnoses with the decision rule results. The primary outcome was a moderate or severe ADE, defined as an unintended and harmful event related to medication use or misuse, which required a change in medical therapy, diagnostic
Pleural or pericardial metastasis: A significant factor affecting efficacy and adverseevents in lung cancer patients treated with PDâ€1/PDâ€L1 inhibitors 30253080 2018 12 07 1759-7714 9 11 2018 Nov Thoracic cancer Thorac Cancer Pleural or pericardial metastasis: A significant factor affecting efficacy and adverseevents in lung cancer patients treated with PD-1/PD-L1 inhibitors. 1500-1508 10.1111/1759-7714.12877 Immunotherapy is a new paradigm for the treatment of non-small-cell lung cancer (...) January 2016 and February 2018. The mean patient age was 63.9 years, and 72.5% (37/51) were male. Most (92.2%, 47/51) had received previous systemic treatment. The overall response rate was 21.6% (11/51). The response rate was significantly lower in patients with pleural or pericardial metastasis than in patients without pleural or pericardial metastasis (4.3% vs. 35.7%; P = 0.007). Patients with pleural or pericardial metastasis had a significantly higher rate of adverseevents of any grade (91.3% vs