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Latest & greatest articles for adverse events
The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms of evidence. If you wanted the latest trusted evidence on adverse events or other clinical topics then use Trip today.
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In patients with non-operatively (conservatively) managed to tendo-achilles (TA) ruptures, is accelerated rehabilitation superior to routine rehabilitation for reducing pain and return to function time, without increasing adverseevents of tendon lengthen Getting Evidence into Clinical Practice: Musculoskeletal Research Facilitation Group (CAT Group) Date:19.11.2016 CAT Lead: Fraser Philp Date CAT completed: 19.11.2016 Email: email@example.com Date CAT to be reviewed: 19.11.2018 Specific (...) Question: In patients with non-operatively (conservatively) managed tendo-achilles (TA) ruptures, is accelerated rehabilitation superior to routine rehabilitation for reducing pain and return to function time, without increasing adverseevents of tendon lengthening and re-rupture rates? Clinical bottom line In patients with non-operatively (conservatively) managed TA ruptures, there is no evidence that compares an accelerated rehabilitation programme against routine rehabilitation. Within the papers
Adverseevents after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population-based cohort study. Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures.We did a cohort study of women in Scotland aged 20 years or older
Crizotinib-Induced Fulminant Hepatic Failure: A Rare AdverseEvent 30241172 2019 03 04 2378-9506 4 2018 Sep Journal of global oncology J Glob Oncol Crizotinib-Induced Fulminant Hepatic Failure: A Rare AdverseEvent. 1-4 10.1200/JGO.2016.007765 Adhikari Narayan N All authors: All India Institute of Medical Sciences, New Delhi, Delhi, India. Kumar Pavnesh P All authors: All India Institute of Medical Sciences, New Delhi, Delhi, India. Venkatesulu Bhanu P BP All authors: All India Institute
Postexposure Prophylaxis After Possible Anthrax Exposure: Adherence and AdverseEvents Anthrax postexposure prophylaxis (PEP) was recommended to 42 people after a laboratory incident that involved potential aerosolization of Bacillus anthracis spores in 2 laboratories at the Centers for Disease Control and Prevention in 2014. At least 31 (74%) individuals who initiated PEP did not complete either the recommended 60 days of antimicrobial therapy or the 3-dose vaccine regimen. Among the 29 (...) that discontinued the antimicrobial component of PEP, most (38%) individuals discontinued PEP because of their low perceived risk of infection; 9 (31%) individuals discontinued prophylaxis due to PEP-related minor adverseevents, and 10% cited both low risk and adverseevents as their reason for discontinuation. Most minor adverseevents reported were gastrointestinal complaints, and none required medical attention. Individuals taking ciprofloxacin were twice as likely (RR = 2.02, 95% CI = 1.1-3.6
US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. The Patient Protection and Affordable Care Act of 2010 brought attention to adverse drug events in national patient safety efforts. Updated, detailed, nationally representative data describing adverse drug events can help focus these efforts.To describe the characteristics of emergency department (ED) visits for adverse drug events in the United States in 2013-2014 and describe changes in ED visits for adverse drug (...) events since 2005-2006.Active, nationally representative, public health surveillance in 58 EDs located in the United States and participating in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project.Drugs implicated in ED visits.National weighted estimates of ED visits and subsequent hospitalizations for adverse drug events.Based on data from 42 585 cases, an estimated 4.0 (95% CI, 3.1-5.0) ED visits for adverse drug events occurred per 1000
Reducing Adverse Drug Events: The Need to Rethink Outpatient Prescribing 27893112 2016 12 13 2018 12 02 1538-3598 316 20 2016 Nov 22 JAMA JAMA Reducing Adverse Drug Events: The Need to Rethink Outpatient Prescribing. 2092-2093 10.1001/jama.2016.16392 Kessler Chad C Durham VA Medical Center, Durham, North Carolina. Ward Michael J MJ Vanderbilt University Medical Center, Nashville, Tennessee. McNaughton Candace D CD Vanderbilt University Medical Center, Nashville, Tennessee. eng K23 HL125670 HL (...) NHLBI NIH HHS United States K23 HL127130 HL NHLBI NIH HHS United States Editorial Comment United States JAMA 7501160 0098-7484 AIM IM JAMA. 2016 Nov 22;316(20):2115-2125 27893129 Drug-Related Side Effects and Adverse Reactions Humans Medication Errors Outpatients 2016 11 29 6 0 2016 11 29 6 0 2016 12 15 6 0 ppublish 27893112 2585959 10.1001/jama.2016.16392 PMC5779096 NIHMS934127 Can J Hosp Pharm. 2015 May-Jun;68(3):202-9 26157181 JAMA. 2016 Nov 22;316(20):2115-2125 27893129 J Med Ethics. 2015 Nov;41
CJEM Infographic: AdverseEvents Following Pediatric Catheterization CJEM Infographic: AdverseEvents Following Pediatric Catheterization - CanadiEM CJEM Infographic: AdverseEvents Following Pediatric Catheterization In , by Simon Huang November 18, 2016 This month CanadiEM is featuring an article from the Canadian Journal of Emergency Medicine (CJEM) that focuses on the use of pediatric catheterization in the emergency department (ED). Currently, catheterization is used in the pediatric ED (...) for diagnosing young children with a suspected urinary tract infection (UTI). However, there have been few studies that have looked at short-term adverseevents in this population. As shown in this CanadiEM infographic, this study by Ouellet-Pelletier et al . 1 set out to assess adverseevents in the week following diagnostic urinary catheterization in children in the pediatric ED. Specifically, a prospective observational study was performed in a single ED at Sainte-Justine University Hospital. Parents
Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverseevents in two systematic reviews. The prevalence of knee osteoarthritis (OA)/degenerative joint disease (DJD) is increasing in the USA. Systematic reviews of treatment efficacy and adverseevents (AEs) of hyaluronic acid (HA) injections report conflicting evidence about the balance of benefits and harms. We review evidence on efficacy and AEs of intraarticular (...) : pooled analysis of ten placebo-controlled, blinded trials showed a standardized mean difference of -0.23 (95 % confidence interval (CI) -0.45 to -0.01) favoring HA at 6 months. Studies reported few serious adverseevents (SAEs) and no significant differences in non-serious adverseevents (NSAEs) (relative risk (RR) [95 % CI] 1.03 [0.93-1.15] or SAEs (RR [95 % CI] 1.39 [0.78-2.47]). A recent prior systematic review reported similar functional outcomes, but significant SAE risk. Differences in SAE
Population Analysis of AdverseEvents in Different Age Groups Using Big Clinical Trials Data Understanding adverseevent 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 adverseevents by age (...) of the clinical trials patients and participants.Two aspects of adverseevent patterns were measured: (1) the adverseevent incidence rate in each of the patient age groups and (2) the diversity of adverseevents defined as distinct types of adverseevents 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
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
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
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 adverseevent occurred in 19%, 16%, and 9% of patients, respectively (P < .001). The most frequent adverseevents leading to discontinuation of treatment were bleeding (with Kaplan-Meier event
Seasonal and Geographic Variation in AdverseEvent 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 AdverseEvent 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
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
Assessment and monitoring of biologic drug adverseevents 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 adverseevents in those with psoriasis receiving treatment with biologic therapies.
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
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
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