scholarly journals Patterns in neurosurgical adverse events: endovascular neurosurgery

2012 ◽  
Vol 33 (5) ◽  
pp. E14 ◽  
Author(s):  
Judith M. Wong ◽  
John E. Ziewacz ◽  
Jaykar R. Panchmatia ◽  
Angela M. Bader ◽  
Aditya S. Pandey ◽  
...  
Keyword(s):  
Adverse Events ◽  
Management Strategies ◽  
Incidence Rates ◽  
Aneurysm Rupture ◽  
Current Evidence ◽  
Related Complication ◽  
Safety Interventions ◽  
Mode Of Detection ◽  
Risk Patients ◽  
Hospital Acquired

As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in endovascular neurosurgery concerning the frequency of adverse events in practice, their patterns, and current methods of reducing the occurrence of these events. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Based on a review of the literature, thromboembolic events appeared to be the most common adverse events in endovascular neurosurgery, with a reported incidence ranging from 2% to 61% depending on aneurysm rupture status and mode of detection of the event. Intraprocedural and periprocedural prevention and rescue regimens are advocated to minimize this risk; however, evidence on the optimal use of anticoagulant and antithrombotic agents is limited. Furthermore, it is unknown what proportion of eligible patients receive any prophylactic treatment. Groin-site hematoma is the most common access-related complication. Data from the cardiac literature indicate an overall incidence of 9% to 32%, but data specific to neuroendovascular therapy are scant. Manual compression, compression adjuncts, and closure devices are used with varying rates of success, but no standardized protocols have been tested on a broad scale. Contrast-induced nephropathy is one of the more common causes of hospital-acquired renal insufficiency, with an incidence of 30% in high-risk patients after contrast administration. Evidence from medical fields supports the use of various preventive strategies. Intraprocedural vessel rupture is infrequent, with the reported incidence ranging from 1% to 9%, but it is potentially devastating. Improvements in device technology combined with proper endovascular technique play an important role in reducing this risk. Occasionally, anatomical or technical difficulties preclude treatment of the lesion of interest. Reports of such occurrences are scant, but existing series suggest an incidence of 4% to 6%. Management strategies for radiation-induced effects are also discussed. The incidence rates are unknown, but protective techniques have been demonstrated. Many of these complications have strategies that appear effective in reducing their risk of occurrence, but development and evaluation of systematic guidelines and protocols have been widely lacking. Furthermore, there has been little monitoring of levels of adherence to potentially effective practices. Protocols and monitoring programs to support integrated implementation may be broadly effective.

OBSERVE-5: Comparison of Etanercept-Treated Psoriasis Patients From Canada and the United States

2018 ◽  
Vol 22 (3) ◽  
pp. 297-303
Author(s):  
Kim A. Papp ◽  
Marc Bourcier ◽  
Yves Poulin ◽  
Charles W. Lynde ◽  
Martin Gilbert ◽  
...  
Keyword(s):  
United States ◽  
Adverse Events ◽  
Maintenance Dose ◽  
Management Strategies ◽  
The United States ◽  
Incidence Rates ◽  
Serious Adverse Events ◽  
End Points ◽  
Safety Outcome ◽  
Medical Interest

Background: OBSERVE-5 surveillance registry results evaluating etanercept safety and effectiveness in patients with moderate to severe psoriasis from Canada and the United States have been reported from data collected between May 2006 and December 2012. Although both countries have an identical indicated starting dose, the maintenance dose can differ and thus affect management strategies and outcomes. Objective: To compare the long-term safety and effectiveness outcomes of etanercept in the Canadian and US cohorts. Methods: Primary end points included exposure-adjusted event incidence rates of serious adverse events and serious infectious events. Secondary end points included exposure-adjusted event incidence rates of events of medical interest and efficacy outcomes. Results: Over 5 years, Canadian patients received a higher maintenance dose of etanercept (50 mg twice/week) more frequently than those from the United States. Safety outcome comparisons revealed that Canadian patients had a significantly lower occurrence of serious adverse events than patients from the United States, with an overall exposure-adjusted event incidence rate per 100 patient-years of 4.46 (95% confidence interval [CI], 3.05-6.29) vs 7.76 (95% CI 7.04-8.54), respectively. Serious infectious event rates were not significantly different between the 2 countries. Secondary outcomes of events of medical interest and effectiveness also did not reveal significant differences between the 2 cohorts. Conclusion: After 5 years of etanercept use, safety and effectiveness outcomes were similar between patients from Canada and the United States, with the exception of a significantly lower rate of serious adverse events in the Canadian population.

scholarly journals How Safe Are Common Analgesics for the Treatment of Acute Pain for Children? A Systematic Review

2016 ◽  
Vol 2016 ◽  
pp. 1-15 ◽  
Author(s):  
Lisa Hartling ◽  
Samina Ali ◽  
Donna M. Dryden ◽  
Pritam Chordiya ◽  
David W. Johnson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dual Therapy ◽  
Pain Medication ◽  
Incidence Rates ◽  
Current Evidence ◽  
Random Effects Model ◽  
National Data ◽  
Oral Medications ◽  
Comprehensive Search ◽  
Inflammatory Drugs

Background. Fear of adverse events and occurrence of side effects are commonly cited by families and physicians as obstructive to appropriate use of pain medication in children. We examined evidence comparing the safety profiles of three groups of oral medications, acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids, to manage acute nonsurgical pain in children (<18 years) treated in ambulatory settings.Methods. A comprehensive search was performed to July 2015, including review of national data registries. Two reviewers screened articles for inclusion, assessed methodological quality, and extracted data. Risks (incidence rates) were pooled using a random effects model.Results. Forty-four studies were included; 23 reported on adverse events. Based on limited current evidence, acetaminophen, ibuprofen, and opioids have similar nausea and vomiting profiles. Opioids have the greatest risk of central nervous system adverse events. Dual therapy with a nonopioid/opioid combination resulted in a lower risk of adverse events than opioids alone.Conclusions. Ibuprofen and acetaminophen have similar reported adverse effects and notably less adverse events than opioids. Dual therapy with a nonopioid/opioid combination confers a protective effect for adverse events over opioids alone. This research highlights challenges in assessing medication safety, including lack of more detailed information in registry data, and inconsistent reporting in trials.

scholarly journals Trauma-Induced Coagulopathy: Overview of an Emerging Medical Problem from Pathophysiology to Outcomes

Medicines ◽  
2021 ◽  
Vol 8 (4) ◽  
pp. 16
Author(s):  
Gabriele Savioli ◽  
Iride Francesca Ceresa ◽  
Luca Caneva ◽  
Sebastiano Gerosa ◽  
Giovanni Ricevuti
Keyword(s):  
Major Trauma ◽  
Management Strategies ◽  
Medical Problem ◽  
Current Evidence ◽  
Potential Drug ◽  
The Past ◽  
Trauma Induced Coagulopathy ◽  
Threatening Condition ◽  
Life Threatening ◽  
Trauma Mortality

Coagulopathy induced by major trauma is common, affecting approximately one-third of patients after trauma. It develops independently of iatrogenic, hypothermic, and dilutive causes (such as iatrogenic cause in case of fluid administration), which instead have a pejorative aspect on coagulopathy. Notwithstanding the continuous research conducted over the past decade on Trauma-Induced Coagulopathy (TIC), it remains a life-threatening condition with a significant impact on trauma mortality. We reviewed the current evidence regarding TIC diagnosis and pathophysiological mechanisms and summarized the different iterations of optimal TIC management strategies among which product resuscitation, potential drug administrations, and hemostatis-focused approaches. We have identified areas of ongoing investigation and controversy in TIC management.

scholarly journals Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001595
Author(s):  
Gerd R Burmester ◽  
Peter Nash ◽  
Bruce E Sands ◽  
Kim Papp ◽  
Lori Stockert ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Special Interest ◽  
Phase 1 ◽  
Incidence Rates ◽  
Study Data ◽  
System Organ Class

ObjectivesTo analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases.MethodsThe analysis included data from patients exposed to ≥1 dose of tofacitinib in phase 1, 2, 3 or 3b/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest.Results13 567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37 066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the ‘infections and infestations’ System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were ≤0.2 across cohorts.ConclusionsThe tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.

scholarly journals Global Trigger Tool methodology to detect adverse events: pilot study at Academic Hospital of Udine

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
E Scarpis ◽  
S Degan ◽  
D De Corti ◽  
F Mellace ◽  
R Cocconi ◽  
...  
Keyword(s):  
Patient Safety ◽  
Adverse Events ◽  
Academic Hospital ◽  
Trigger Tool ◽  
Hospital Acquired Infections ◽  
Frequent Type ◽  
Global Trigger Tool ◽  
Clinical Records ◽  
Hospital Acquired ◽  
Over Time

Abstract Introduction Identification and measurement of adverse events (AEs) is crucial for patient safety in order to monitor them over time and to implement quality improvement programs, testing if they are effective. Global Trigger Tool (GTT) has been proposed as a low-cost method, being also the most effective to detect AEs. This study aims to describe the number of triggers, the rate and level of AEs identified by GTT and the most frequent type of AE. Methods The Italian version of the GTT was used. Ten paper-based clinical records (CRs) randomly selected every 2 weeks were reviewed from January to April 2019 by three independent reviewers (two nurses, one doctor) at the Academic Hospital of Udine. The AEs rates calculated are: AEs per 1,000 patient-days, AEs per 100 admissions, percentage of admissions with an AE. AEs were classified by harm levels according to National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). Results CRs reviewed were 80. Mean age of the patients was 69.3±16.4, women were 37.5%. Mean hospitalisation was 16.8±15.3. Nine were the cases of re-hospitalisation within 30 days (11.3%). The total number of trigger was 156. AEs were 31, with at least one AE on 27.5% of admissions, 38.8 AEs per 100 admissions and 23 AEs per 1,000 patient-days. AEs with harm level E, F and H were respectively 5 (16.1%), 24 (77.4%) and 2 (6.5%). The most frequent type of AE were hospital acquired infections with 15 cases (48.4%). Conclusions The most frequent type of AE was the hospital acquired infections. Rates and levels of AEs were higher than other international studies, probably because of the limited number of CRs reviewed. Key messages Global Trigger Tool is an effective method to detect adverse patient safety events in order to monitor them over time. The most frequent type of adverse events was the hospital acquired infections.

scholarly journals Review on the Regional Effects of Gastrointestinal Luminal Stimulation on Appetite and Energy Intake: (Pre)clinical Observations

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1601
Author(s):  
Jennifer Wilbrink ◽  
Gwen Masclee ◽  
Tim Klaassen ◽  
Mark van Avesaat ◽  
Daniel Keszthelyi ◽  
...  
Keyword(s):  
Energy Intake ◽  
Oral Delivery ◽  
Regional Differences ◽  
Management Strategies ◽  
Inhibitory Effect ◽  
Current Evidence ◽  
Ileal Brake ◽  
Regional Effects ◽  
Clinical Observations ◽  
Intestinal Delivery

Macronutrients in the gastrointestinal (GI) lumen are able to activate “intestinal brakes”, feedback mechanisms on proximal GI motility and secretion including appetite and energy intake. In this review, we provide a detailed overview of the current evidence with respect to four questions: (1) are regional differences (duodenum, jejunum, ileum) present in the intestinal luminal nutrient modulation of appetite and energy intake? (2) is this “intestinal brake” effect macronutrient specific? (3) is this “intestinal brake” effect maintained during repetitive activation? (4) can the “intestinal brake” effect be activated via non-caloric tastants? Recent evidence indicates that: (1) regional differences exist in the intestinal modulation of appetite and energy intake with a proximal to distal gradient for inhibition of energy intake: ileum and jejunum > duodenum at low but not at high caloric infusion rates. (2) the “intestinal brake” effect on appetite and energy appears not to be macronutrient specific. At equi-caloric amounts, the inhibition on energy intake and appetite is in the same range for fat, protein and carbohydrate. (3) data on repetitive ileal brake activation are scarce because of the need for prolonged intestinal intubation. During repetitive activation of the ileal brake for up to 4 days, no adaptation was observed but overall the inhibitory effect on energy intake was small. (4) the concept of influencing energy intake by intra-intestinal delivery of non-caloric tastants is intriguing. Among tastants, the bitter compounds appear to be more effective in influencing energy intake. Energy intake decreases modestly after post-oral delivery of bitter tastants or a combination of tastants (bitter, sweet and umami). Intestinal brake activation provides an interesting concept for preventive and therapeutic approaches in weight management strategies.

Long-term outcomes of Japan-specific dosage of rivaroxaban in high-risk patients with non-valvular atrial fibrillation: analysis from the XAPASS

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Ikeda ◽  
S Ogawa ◽  
T Kitazono ◽  
J Nakagawara ◽  
K Minematsu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Major Bleeding ◽  
Factor Xa ◽  
Incidence Rates ◽  
Funding Source ◽  
High Risk Patients ◽  
Reduced Dose ◽  
Risk Patients

Abstract Background XAPASS is a real-world, prospective, single-arm, observational study conducted as a post-marketing surveillance mandated by the health authority in Japan. Nowadays, direct oral anticoagulant therapy using factor Xa or thrombin inhibitor has been the standard of care for patients with non-valvular atrial fibrillation (NVAF) to prevent ischemic stroke. However, the clinical impact of reduced dosage (approved dose of 15 or 10 mg once daily in Japan is relatively reduced compared to global dosage) factor Xa inhibitor rivaroxaban in high-risk patients remains unclear. Purpose The present sub-analysis of XAPASS was carried out to assess long-term safety and effectiveness of reduced-dose rivaroxaban in high-risk NVAF patients for bleeding and thromboembolism. Methods All patients with NVAF who were newly started on rivaroxaban were eligible for surveillance. The principal safety outcome was a composite of major and non-major bleeding events, and the primary effectiveness outcome was a composite of ischaemic stroke, haemorrhagic stroke, non-central nervous system systemic embolism (non-CNS SE), and myocardial infarction (MI). In this present sub-analysis, high-risk patients were defined as those who had two of the following three risk factors: elderly (≥75 years old), low body weight (≤50 kg), and renal impairment (CrCl &lt;50 mL/min). Results In total, 11,308 patients were enrolled between April 2012 and June 2014 from 1,419 hospitals, and overall data were analysed from 10,664 patients from whom data were collected. Among them, 3,694 patients matched the criteria for the high-risk patients defined in this sub-analysis, and 6,970 patients did not match the criteria (non-high-risk patients). The mean treatment duration was 791±673 days in the high-risk patients and 944±709 days in the non-high-risk patients. Mean patient age was 80.9±5.5 years and 69.0±9.0 years at baseline, respectively. Mean CHADS2 score was 2.8 and 1.8, and CHA2DS2-VASc score was 4.4 and 2.9, respectively. The rates of CHADS2 component comorbidities were lower in the non-high-risk patients except for diabetes mellitus. The incidence rates of any bleeding, major bleeding, and the primary effectiveness outcomes were 4.8, 1.6, and 2.1%/patient-year in the high-risk patients. The incidence rates of these clinical events in the non-high-risk patients were 3.3, 0.9, and 1.0%/patient-year, respectively. Conclusions Incidence rates of long-term bleeding and thromboembolism were higher in the high-risk patients than in the non-high-risk patients. However, the rates of these outcomes using the Japan-specific reduced dose were not so high. Furthermore, the balance between safety and effectiveness outcomes was within an acceptable range. The present study provides useful information for physicians to stratify high-risk patients using the reduced dose in daily clinical practice. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer Yakuhin Ltd.

scholarly journals Severity of gastric intestinal metaplasia predicts the risk of gastric cancer: a prospective multicentre cohort study (GCEP)

Gut ◽  
2021 ◽  
pp. gutjnl-2021-324057
Author(s):  
Jonathan W J Lee ◽  
Feng Zhu ◽  
Supriya Srivastava ◽  
Stephen KK Tsao ◽  
Christopher Khor ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Intestinal Metaplasia ◽  
Significant Risk ◽  
Incidence Rates ◽  
Endoscopic Surveillance ◽  
Smoking History ◽  
Operating Characteristics ◽  
Gastric Intestinal Metaplasia ◽  
Risk Patients ◽  
Prospective Longitudinal

ObjectiveTo investigate the incidence of gastric cancer (GC) attributed to gastric intestinal metaplasia (IM), and validate the Operative Link on Gastric Intestinal Metaplasia (OLGIM) for targeted endoscopic surveillance in regions with low-intermediate incidence of GC.MethodsA prospective, longitudinal and multicentre study was carried out in Singapore. The study participants comprised 2980 patients undergoing screening gastroscopy with standardised gastric mucosal sampling, from January 2004 and December 2010, with scheduled surveillance endoscopies at year 3 and 5. Participants were also matched against the National Registry of Diseases Office for missed diagnoses of early gastric neoplasia (EGN).ResultsThere were 21 participants diagnosed with EGN. IM was a significant risk factor for EGN (adjusted-HR 5.36; 95% CI 1.51 to 19.0; p<0.01). The age-adjusted EGN incidence rates for patients with and without IM were 133.9 and 12.5 per 100 000 person-years. Participants with OLGIM stages III–IV were at greatest risk (adjusted-HR 20.7; 95% CI 5.04 to 85.6; p<0.01). More than half of the EGNs (n=4/7) attributed to baseline OLGIM III–IV developed within 2 years (range: 12.7–44.8 months). Serum trefoil factor 3 distinguishes (Area Under the Receiver Operating Characteristics 0.749) patients with OLGIM III–IV if they are negative for H. pylori. Participants with OLGIM II were also at significant risk of EGN (adjusted-HR 7.34; 95% CI 1.60 to 33.7; p=0.02). A significant smoking history further increases the risk of EGN among patients with OLGIM stages II–IV.ConclusionsWe suggest a risk-stratified approach and recommend that high-risk patients (OLGIM III–IV) have endoscopic surveillance in 2 years, intermediate-risk patients (OLGIM II) in 5 years.

scholarly journals Stroke Prevention in Atrial Fibrillation: Where are We Now?

2012 ◽  
Vol 6 ◽  
pp. CMC.S8976 ◽  
Author(s):  
Yousif Ahmad ◽  
Gregory Y.H. Lip
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Prevention ◽  
Management Strategies ◽  
Bleeding Risk ◽  
Long Term Study ◽  
Risk Patients ◽  
First Time ◽  
Major Progress ◽  
Made In

Atrial fibrillation is the commonest arrhythmia worldwide and is a growing problem. AF is responsible for 25% of all strokes, and these patients suffer greater mortality and disability. Warfarin has traditionally been the only successful therapy for stroke prevention, but its limitations have resulted in underutilisation. Major progress has been made in AF research, leading to improved management strategies. Better risk stratification permits identification of truly low-risk patients who do not require anticoagulation and we are able to simplify ourevaluation of a patient's bleeding risk. The advent of novel anticoagulants means warfarin is no longer the only choice for stroke prophylaxis. These drugs circumvent many of warfarin's inconveniences, but only long-term study and use will conclusively demonstrate how they compare to warfarin. The landscape of stroke prevention in AF has changed with effective alternatives to warfarin available for the first time in 60 years—but each new option brings new considerations.

scholarly journals Toward the diagnosis of rare childhood genetic diseases: what do parents value most?

2021 ◽  
Author(s):  
Samantha Pollard ◽  
Deirdre Weymann ◽  
Jessica Dunne ◽  
Fatemeh Mayanloo ◽  
John Buckell ◽  
...  
Keyword(s):  
Focus Groups ◽  
Genetic Disease ◽  
Diagnostic Yield ◽  
Management Strategies ◽  
Health Benefit ◽  
Sampling Technique ◽  
Evidence Base ◽  
Current Evidence ◽  
Genomic Testing ◽  
Current Evidence Base

AbstractGenomic testing is becoming routine for diagnosing rare childhood genetic disease. Evidence underlying sustainable implementation is limited, focusing on short-term endpoints such as diagnostic yield, unable to fully characterize patient and family valued outcomes. Although genomic testing is becoming widely available, evidentiary and outcomes uncertainty persist as key challenges for implementation. We examine whether the current evidence base reflects public tolerance for uncertainty for genomics to diagnose rare childhood genetic disease. We conducted focus groups with general population parents in Vancouver, Canada, and Oxford, United Kingdom, to discuss expectations and concerns related to genomic testing to diagnose rare childhood genetic disease. Applying a purposive sampling technique, recruitment continued until thematic saturation was reached. Transcripts were analysed using thematic analysis. Thirty-three parents participated across four focus groups. Participants valued causal diagnoses alongside management strategies to improve patient health and wellbeing. Further, participants valued expanding the evidence base to reduce evidentiary uncertainty while ensuring security of information. Willingness to pay out of pocket for testing reflected perceived familial health benefit. Diagnostic yield fails to fully capture valued outcomes, and efforts to resolve uncertainty better reflect public priorities. Evaluations of genomic testing that fully integrate valued endpoints are necessary to ensure consistency with best practices and public willingness to accept the uncertain familial benefit.

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