Latest & greatest articles for adverse events

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Top results for adverse events

141. Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data (PubMed)

Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans.The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age (...) of the clinical trials patients and participants.Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained

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2016 JMIR medical informatics

142. Evaluation of 5 Prognostic Scores for Prediction of Stroke, Thromboembolic and Coronary Events, All-Cause Mortality, and Major Adverse Cardiac Events in Patients With Atrial Fibrillation and Coronary Stenting (PubMed)

Evaluation of 5 Prognostic Scores for Prediction of Stroke, Thromboembolic and Coronary Events, All-Cause Mortality, and Major Adverse Cardiac Events in Patients With Atrial Fibrillation and Coronary Stenting Management of antithrombotic therapy in patients with atrial fibrillation (AF) and coronary stenting remains challenging, and there is a need for efficient tools to predict their risk of different types of cardiovascular events and death. Several scores exist such as the CHA2DS2-VASc score (...) , the Global Registry of Acute Coronary Events (GRACE) score, the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score, the Anatomical and Clinical Syntax II Score and the Reduction of Atherothrombosis for Continued Health score. These 5 scores were investigated in patients with AF with coronary stenting with the aim of determining which was most predictive for stroke/thromboembolic (TE) events, nonlethal coronary events, all-cause mortality, and major adverse

2016 EvidenceUpdates

143. Diagnostic Accuracy of High-Sensitivity Cardiac Troponin T at Presentation Combined With History and ECG for Ruling Out Major Adverse Cardiac Events (PubMed)

Diagnostic Accuracy of High-Sensitivity Cardiac Troponin T at Presentation Combined With History and ECG for Ruling Out Major Adverse Cardiac Events We evaluate the diagnostic accuracy of a high-sensitivity cardiac troponin T (hs-cTnT) level less than 5 ng/L or less than or equal to 14 ng/L at emergency department (ED) presentation, combined with the emergency physician's assessment of history and ECG, for ruling out major adverse cardiac events within 30 days.This prospective observational (...) study enrolled consecutive ED chest pain patients. Emergency physicians' assessments of patient history and ECG were collected. The primary outcome was 30-day major adverse cardiac events, defined as acute myocardial infarction, unstable angina, cardiogenic shock, ventricular arrhythmia, atrioventricular block, cardiac arrest, or death of cardiac or unknown cause.A total of 1,138 patients were included in the final analysis. The combination of hs-cTnT less than 5 ng/L, a nonischemic ECG result

2016 EvidenceUpdates

144. Effectiveness of continuous or intermittent vital signs monitoring in preventing adverse events on general wards: a systematic review and meta-analysis (PubMed)

Effectiveness of continuous or intermittent vital signs monitoring in preventing adverse events on general wards: a systematic review and meta-analysis Vital signs monitoring is an old hospital practice for patient safety but evaluation of its effectiveness is not widespread. We aimed to identify strategies to improve intermittent or continuous vital signs monitoring in general wards; and their effectiveness in preventing adverse events on general hospital wards.Publications searched between (...) of patient deterioration, increased rapid response activations and improvements in timeliness or completeness of vital signs documentation. Innovative intermittent monitoring approaches are associated with modest reduction in in-hospital mortality over intermittent vital signs monitoring in 'usual care'. However, there was no evidence of significant reduction in ICU transfers or other adverse events with either intermittent or continuous monitoring.This review of heterogeneous monitoring approaches found

2016 EvidenceUpdates

145. Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event (PubMed)

Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event To assess adverse event (AE) resolution, delivery mode and neonatal outcomes after misoprostol or dinoprostone vaginal insert (MVI or DVI) retrieval due to AE during induction of labour (IOL).Randomised, double-blind trial, EXPEDITE.Thirty five obstetric departments, USA.Consisted of 1358 pregnant women with modified Bishop score ≤4 eligible for pharmacological (...) and DVI, respectively (P = 0.440).AEs leading to insert retrieval were primarily uterine tachysystole with FHR involvement and category II/III FHR patterns. Insert retrieval due to an AE did not prolong time to delivery for either prostaglandin insert.Induction with prostaglandin vaginal inserts: outcomes following retrieval due to intrapartum adverse event.© 2016 Ferring Pharmaceuticals. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal

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2016 EvidenceUpdates

146. Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. (PubMed)

Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. In the PEGASUS-TIMI 54 trial, treatment with ticagrelor reduced the incidence of cardiovascular death, myocardial infarction, or stroke by 15% to 16% among stable patients compared with placebo. However, more patients prematurely discontinued treatment with ticagrelor than with placebo.To investigate the reasons and timing (...) was evaluated by treatment arm, cause, and timing. This analysis was initiated in May 2015.Discontinuation of treatment.Over 33 months, 32%, 29%, and 21% of patients receiving 90 mg of ticagrelor, 60 mg of ticagrelor, and placebo, respectively, discontinued treatment (P < .001). Discontinuation of treatment due to an adverse event occurred in 19%, 16%, and 9% of patients, respectively (P < .001). The most frequent adverse events leading to discontinuation of treatment were bleeding (with Kaplan-Meier event

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2016 JAMA cardiology

147. Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in Patients With Type 2 Diabetes: A Meta-analysis. (PubMed)

Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in Patients With Type 2 Diabetes: A Meta-analysis. Numerous glucose-lowering drugs are used to treat type 2 diabetes.To estimate the relative efficacy and safety associated with glucose-lowering drugs including insulin.Cochrane Library Central Register of Controlled Trials, MEDLINE, and EMBASE databases through March 21, 2016.Randomized clinical trials of 24 weeks' or longer duration.Random-effects network (...) meta-analysis.The primary outcome was cardiovascular mortality. Secondary outcomes included all-cause mortality, serious adverse events, myocardial infarction, stroke, hemoglobin A1c (HbA1C) level, treatment failure (rescue treatment or lack of efficacy), hypoglycemia, and body weight.A total of 301 clinical trials (1,417,367 patient-months) were included; 177 trials (56,598 patients) of drugs given as monotherapy; 109 trials (53,030 patients) of drugs added to metformin (dual therapy); and 29

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2016 JAMA

148. Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. (PubMed)

Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. Five medications have been approved for the management of obesity, but data on comparative effectiveness are limited.To compare weight loss and adverse events among drug treatments for obesity using a systematic review and network meta-analysis.MEDLINE, EMBASE, Web of Science, Scopus, and Cochrane Central from inception to March 23, 2016; clinical trial (...) under the cumulative ranking (SUCRA) probabilities. Quality of evidence was assessed using GRADE criteria.Proportions of patients with at least 5% weight loss and at least 10% weight loss, magnitude of decrease in weight, and discontinuation of therapy because of adverse events at 1 year.Twenty-eight randomized clinical trials with 29 018 patients (median age, 46 years; 74% women; median baseline body weight, 100.5 kg; median baseline body mass index, 36.1) were included. A median 23% of placebo

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2016 JAMA

149. Seasonal and Geographic Variation in Adverse Event Reporting (PubMed)

Seasonal and Geographic Variation in Adverse Event Reporting Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event (ADE) reporting over variable time frames, seasonality of ADEs may have implications (...) for signal detection.The aim of this study was to investigate whether a set of illnesses that might be expected to display seasonality in general, did so when spontaneously reported as ADEs.We performed our analysis with the publically available US FDA Adverse Event Reporting System (FAERS) data. We selected a convenience sample of events possibly triggered by seasonal factors (hypothermia, Raynaud's phenomenon, photosensitivity reaction, heat exhaustion, heat stroke, and sunburn) and events for which

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2016 Drugs - real world outcomes

150. Usefulness of the Myocardial Infarction and Cardiac Arrest Calculator as a Discriminator of Adverse Cardiac Events After Elective Hip and Knee Surgery (PubMed)

Usefulness of the Myocardial Infarction and Cardiac Arrest Calculator as a Discriminator of Adverse Cardiac Events After Elective Hip and Knee Surgery The 2014 American College of Cardiology and American Heart Association guidelines on perioperative evaluation recommend differentiating patients at low risk (<1%) versus elevated risk (≥1%) for cardiac complications to guide appropriate preoperative testing. Among the tools recommended for estimating perioperative risk is the National Surgical (...) Quality Improvement Program (NSQIP) Myocardial Infarction and Cardiac Arrest (MICA) risk calculator. We investigated whether the NSQIP MICA risk calculator would accurately discriminate adverse cardiac events in a cohort of adult patients undergoing elective orthopedic surgery. We retrospectively reviewed 1,098 consecutive, elective orthopedic surgeries performed at Hershey Medical Center from January 1, 2013, to December 31, 2014. Adverse cardiac events were defined as myocardial infarction

2016 EvidenceUpdates

151. Assessment and monitoring of biologic drug adverse events in patients with psoriasis (PubMed)

Assessment and monitoring of biologic drug adverse events in patients with psoriasis Current treatment guidelines for biologic therapies in psoriasis differ in their recommendation for the monitoring of adverse events.The aim of this paper was to draw together evidence from the currently available guidelines as a summary of how biologics licensed for the treatment of psoriasis should be monitored for adverse events.The MEDLINE database was searched to identity the current literature (...) in clinical practice are supported by minimal clinical evidence, highlighting the need for more studies to evaluate the role and value of the different modalities of screening and monitoring for adverse events in those with psoriasis receiving treatment with biologic therapies.

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2016 Psoriasis (Auckland, N.Z.)

152. Aromatase inhibitors alone or sequentially combined with tamoxifen in postmenopausal early breast cancer compared with tamoxifen or placebo - Meta-analyses on efficacy and adverse events based on randomized clinical trials. (PubMed)

Aromatase inhibitors alone or sequentially combined with tamoxifen in postmenopausal early breast cancer compared with tamoxifen or placebo - Meta-analyses on efficacy and adverse events based on randomized clinical trials. Tamoxifen (TAM) and aromatase inhibitors (AI) are adjuvant therapy options for postmenopausal women with estrogen receptor positive (ER+) breast cancer. This systematic review of seven randomized controlled studies comparing TAM and AI, and one study comparing extended (...) therapy with an AI with placebo after about 5 years of tamoxifen, aims to assess long-term clinical efficacy and adverse events. The literature review was performed according to the principles of the Cochrane Collaboration. The search included common databases up to 2013-01-14. Studies of high or moderate quality were used for grading of evidence. Revman™ software was utilized for meta-analyses of published data. Disease free survival (DFS) and overall survival (OS) were improved with AI monotherapy

2016 Breast (Edinburgh, Scotland)

153. Medicines Management, Medication Errors and Adverse Medication Events in Older People Referred to a Community Nursing Service: A Retrospective Observational Study (PubMed)

Medicines Management, Medication Errors and Adverse Medication Events in Older People Referred to a Community Nursing Service: A Retrospective Observational Study Increasing numbers of older people are receiving support with medicines management from community nursing services (CNSs) to enable them to live in their own homes. Little is known about these people and the support they receive.To explore the characteristics of older people referred for medicines management support, type of support (...) provided, medication errors and adverse medication events (AMEs).A retrospective observational study of a random sample of 100 older people referred to a large non-profit CNS for medicines management support over a 3-month period was conducted. Measures were: demographics, referral source, current medical problems, medicines, medication aids, types of medication authorisations used by nurses, frequency of nurse visits and type of support provided, medication errors, AMEs and interdisciplinary teamwork

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2016 Drugs - real world outcomes

154. Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. (PubMed)

Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. Few cardiovascular outcomes trials have been conducted for obesity treatments. Withdrawal of 2 marketed drugs has resulted in controversy about the cardiovascular safety of obesity agents.To determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events (MACE, defined as cardiovascular (...) group and 90 patients (2.0%) in the naltrexone-bupropion group (HR, 0.88; adjusted 99.7% CI, 0.57-1.34). Adverse effects were more common in the naltrexone-bupropion group, including gastrointestinal events in 14.2% vs 1.9% (P < .001) and central nervous system symptoms in 5.1% vs 1.2% (P < .001).Among overweight or obese patients at increased cardiovascular risk, based on the interim analyses performed after 25% and 50% of planned events, the upper limit of the 95% CI of the HR for MACE

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2016 JAMA

155. Comparison of the Global Registry of Acute Coronary Events Risk Score Versus the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse outcomes With Early Implementation of the ACC/AHA Guidelines Risk Score to Predict In-Hospital Mort (PubMed)

Comparison of the Global Registry of Acute Coronary Events Risk Score Versus the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse outcomes With Early Implementation of the ACC/AHA Guidelines Risk Score to Predict In-Hospital Mort Risk assessment plays a major role in the management of acute coronary syndrome. The aim was to compare the performance of the Global Registry of Acute Coronary Events (GRACE) and the Can Rapid risk stratification of Unstable angina patients (...) Suppress Adverse outcomes with Early implementation of the American College of Cardiology/American Heart Asociation guidelines (CRUSADE) risk scores to predict in-hospital mortality and major bleeding (MB) in 1,587 consecutive patients with acute coronary syndrome. In-hospital deaths and bleeding complications were prospectively collected. Bleeding complications were defined according to CRUSADE and Bleeding Academic Research Consortium (BARC) criteria. During the hospitalization, 71 patients (4.5

2016 EvidenceUpdates

156. RE: A systematic review of patients' experiences of adverse events in health care. (PubMed)

RE: A systematic review of patients' experiences of adverse events in health care. 26843549 2016 08 24 2018 12 02 1464-3677 28 2 2016 Apr International journal for quality in health care : journal of the International Society for Quality in Health Care Int J Qual Health Care Re: A systematic review of patients' experiences of adverse events in health care. 264 10.1093/intqhc/mzw004 Sarkar Urmimala U UCSF Division of General Internal Medicine, UCSF Center for Vulnerable Populations, Department

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2016 International journal for quality in health care : journal of the International Society for Quality in Health Care / ISQua

157. Predictive Validity of the Beers and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States (PubMed)

Predictive Validity of the Beers and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States To compare the predictive validity of the 2003 Beers, 2012 American Geriatrics Society (AGS) Beers, and Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria.Retrospective cohort.Managed care administrative claims data from 2006 (...) to 2009.Commercially insured persons aged 65 and older in the United States (N=174,275).Association between adverse drug events (ADEs), emergency department (ED) visits, and hospitalization outcomes and inappropriate medication use using time-varying Cox proportional hazard models. Measures of model discrimination (c-index) and hazard ratios (HRs) were calculated to compare unadjusted and adjusted models for associations.The prevalence of inappropriate prescribing was 34.1% for the 2012 AGS Beers

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2016 EvidenceUpdates

158. Observational study: Emergency department visits and hospitalisations for adverse events related to dietary supplements are common

Observational study: Emergency department visits and hospitalisations for adverse events related to dietary supplements are common Emergency department visits and hospitalisations for adverse events related to dietary supplements are common | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about how we use cookies, please see our . Log in using your (...) username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? Search for this keyword Search for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here Emergency department visits and hospitalisations for adverse events related to dietary supplements are common Article Text Aetiology/Harm Observational

2016 Evidence-Based Medicine (Requires free registration)

159. Systematic review with meta analysis: Low to moderate quality evidence demonstrates the potential benefits and adverse events of cannabinoids for certain medical indications

Systematic review with meta analysis: Low to moderate quality evidence demonstrates the potential benefits and adverse events of cannabinoids for certain medical indications Low to moderate quality evidence demonstrates the potential benefits and adverse events of cannabinoids for certain medical indications | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time (...) and adverse events of cannabinoids for certain medical indications Article Text Therapeutics/Prevention Systematic review with meta analysis Low to moderate quality evidence demonstrates the potential benefits and adverse events of cannabinoids for certain medical indications Kevin P Hill 1 , W Max Hurley-Welljams-Dorof 2 Statistics from Altmetric.com Commentary on : Whiting PF , Wolff RF , Deshpande S , et al . Cannabinoids for medical use: a systematic review and meta-analysis . Context As of September

2016 Evidence-Based Medicine (Requires free registration)

160. Adverse events in oncology patients with reduced platelet counts and oncurrent anemia

Adverse events in oncology patients with reduced platelet counts and oncurrent anemia Adverse events in oncology patients with reduced platelet counts and oncurrent anemia Adverse events in oncology patients with reduced platelet counts and oncurrent anemia Mitchell MD, Wagner J, Wong,TC, Mull N 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 Mitchell MD, Wagner J, Wong,TC, Mull N. Adverse events in oncology patients with reduced platelet counts and oncurrent anemia. Philadelphia: Center for Evidence-based Practice (CEP). 2016 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Anemia; Humans; Leukopenia; Medical Oncology; Platelet Count; Thrombocytopenia Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence

2016 Health Technology Assessment (HTA) Database.