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European Journal of Cardiovascular... Apr 2022Left ventricular assist devices (LVAD) are used to treat advanced heart failure, and the use of these devices in ever increasing, with over 19 000 people having had a...
AIMS
Left ventricular assist devices (LVAD) are used to treat advanced heart failure, and the use of these devices in ever increasing, with over 19 000 people having had a device. However, during device therapy over 50% of patients will have some type of major adverse event. The aim of this study was to examine whether having a major adverse event, including major infection and major bleed, would alter patient-reported outcomes over time, including depressive symptoms and health-related quality of life.
METHODS AND RESULTS
T-tests and χ2 analyses were used to determine significant differences between patients who had an adverse event and those who did not. Latent curve growth modelling was used to evaluate change over time in those patients with and without and adverse event. The only difference between those with and without an adverse event was pre-implant depressive symptoms and health-related quality of life. The trajectories of both groups were also similar, with only differences at the pre-implant time point.
CONCLUSION
In response to an adverse event occurring post-LVAD implantation, we found that patient-reported outcomes, including depressive symptoms and health-related quality of life were not significantly impacted.
Topics: Heart Failure; Heart-Assist Devices; Hemorrhage; Humans; Patient Reported Outcome Measures; Quality of Life; Retrospective Studies
PubMed: 34453523
DOI: 10.1093/eurjcn/zvab070 -
Journal of Healthcare Engineering 2021Adverse nursing events occur suddenly, unpredictably, or unexpectedly during course of clinical diagnosis and treatment processes in the hospitals. These events...
Adverse nursing events occur suddenly, unpredictably, or unexpectedly during course of clinical diagnosis and treatment processes in the hospitals. These events adversely affect the patient's diagnosis and treatment results and even increase the patient's pain and burden. Additionally, It is high likely to cause accidents and disputes and affect normal medical work and personnel safety and is not conducive to the development of the health system. Due to the rapid development of modern medicine, health and safety of patients have become the most concerned issue in society and patient safety is an important part of medical care management. Research and events have shown that classified management of adverse nursing events, event analysis, and improvement measures are beneficial, specifically to the health system, to continuously improve the quality of medical care and reduce the occurrence of adverse nursing events. In the management of adverse nursing events, it is very important to categorize the text reports of adverse nursing events and divide these into different categories and levels. Traditional reports of adverse nursing events are mostly unstructured and simple data, often relying on manual classification, which is difficult to analyze. Furthermore, data is relatively inaccurate and practical reference significance is not obvious. In this paper, we have extensively evaluated various deep learning-based classification methods which are specifically designed for the healthcare systems. It becomes possible with the development of science and technology; text classification methods based on deep learning are gradually entering people's field of vision. Additionally, we have proposed a text classification model for adverse nursing events in the health system. Experiments and data comparison test of both the proposed deep learning-based method and existing methods in the text classification of nursing adverse events effect are performed. These results show the exceptional performance of the proposed mechanism in terms of various evaluation metrics.
Topics: Deep Learning; Delivery of Health Care; Drug-Related Side Effects and Adverse Reactions; Hospitals; Humans; Patient Safety
PubMed: 34840707
DOI: 10.1155/2021/9800114 -
World Journal of Hepatology Jul 2021Drug use during pregnancy is not common. Drug-induced liver injury (DILI) is a potential complication that is rare but can adversely affect both the mother and the... (Review)
Review
Drug use during pregnancy is not common. Drug-induced liver injury (DILI) is a potential complication that is rare but can adversely affect both the mother and the fetus. Although many drugs can directly cause hepatotoxicity, idiosyncratic liver injury is common in pregnancy. Underreporting of adverse drug reactions, lack of adequate literature regarding drug safety in pregnancy, and the inherent difficulty in diagnosing DILI during pregnancy make the management of this condition challenging. This review attempts to describe the existing literature regarding DILI in pregnancy, which is mainly in the form of case reports; several studies have looked at the safety of antithyroid drugs, antiretroviral drugs, and paracetamol, which have an indication for use in pregnancy; the relevant data from these studies with regard to DILI has been presented. In addition, the review describes the diagnosis of DILI, grading the disease severity, assessment of causality linking the drug to the adverse event, regulatory guidelines for evaluating the potential of drugs to cause liver injury, efforts to ensure better participation of women in clinical trials and studies in pregnant women population in particular, and the challenges involved in generating adequate research evidence. The establishment of DILI registries in various countries is an encouraging development; however, there is a need for promoting active, spontaneous reporting of adverse events during pregnancy to ensure rapid generation of evidence regarding the safety of a drug in pregnant women.
PubMed: 34367496
DOI: 10.4254/wjh.v13.i7.747 -
Preventive Medicine Reports Dec 2021Although medical error has been estimated as a major cause of death in the US, the capability of current diagnostic coding systems and standard death certificates to...
Although medical error has been estimated as a major cause of death in the US, the capability of current diagnostic coding systems and standard death certificates to capture these events has been criticized. This register-based study aimed to scrutinize medical adverse event deaths (i.e., deaths due to adverse events occurring within the healthcare practice, avoidable or unavoidable, including late complications and sequelae of such events) in the US National Vital Statistics 2018 mortality dataset. Individual-level data on underlying and multiple causes of death according to the tenth revision of the International Classification of Diseases (ICD-10) coding system were extracted together with the decedents' sex, age, ethnicity and education level. Adverse event deaths were identified by ICD-10 codes Y40-Y84 and Y88. The dataset comprised a total of 2 846 305 certified deaths. An adverse event ICD-10 code was used as the underlying cause of death in 0.16% (n = 4620) of the cases, and appeared on the list of multiple causes in 1.13% (n = 32 226) of the cases. Odds for adverse event death were higher among younger than elderly individuals, among those of black than white ethnicity, and among individuals with higher education level. The present data indirectly support previous evidence that a large number of adverse events remain underrecognized or misclassified. Future analyses are needed to reveal the root causes behind underreporting and to analyze whether it occurs at random or in a systematic way.
PubMed: 34976638
DOI: 10.1016/j.pmedr.2021.101574 -
JSLS : Journal of the Society of... 2022Staple line leaks are a serious problem in bariatric surgery and a major cause of serious morbidity and mortality. Adverse events caused by medical devices are reported...
BACKGROUND
Staple line leaks are a serious problem in bariatric surgery and a major cause of serious morbidity and mortality. Adverse events caused by medical devices are reported to the Food and Drug Administration which maintains the Manufacturer and User Facility Device Experience (MAUDE) database. We examined adverse stapler events reported to the MAUDE database, specifically with regards to bariatric surgery.
METHODS
The MAUDE database was queried for adverse events caused by staplers between January 1, 2018 - December 31, 2020; events reported by Intuitive, Ethicon, and Medtronic/Covidien; and limited our search to "gastric bypass", "sleeve gastrectomy", "stapler malfunction" combined with each company.
RESULTS
There were 883 adverse events reported for Medtronic, 353 for Ethicon, and 35 for Intuitive. Approximately 3.5 million staple reloads sold in the study period. The reported misfire rate for Medtronic was 0.04% and for Ethicon was 0.02%. Data for Intuitive was unavailable. The most common reported event for Medtronic was failure to fire (n = 349), followed by misfire (n = 186). For Ethicon, the most common event was failure to fire (n = 146), followed by mechanical problems (n = 27). The most common event with the Intuitive stapler was leak (n = 10) and bleeding from staple line (n = 8).
CONCLUSIONS
Stapler malfunction is a very rare event in metabolic and bariatric surgery. All of the major stapler producers have transitioned to powered staplers with excellent safety profiles. Open and honest reporting about stapler malfunction is essential to determine the true safety of these ubiquitous devices.
Topics: Databases, Factual; Gastric Bypass; Humans
PubMed: 35281706
DOI: 10.4293/JSLS.2021.00074 -
Frontiers in Physiology 2014New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by...
PURPOSE
New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse event co-occurrences.
METHODS
We analyzed the similarity of adverse event profiles of 2347 patients extracted from EMRs from a mental health center in Denmark. The patients were clustered based on their adverse event profiles and the similarities were presented as a network. The set of adverse events in each main patient cluster was evaluated. Co-occurrences of adverse events in patients (p-value < 0.01) were identified and presented as well.
RESULTS
We found that each cluster of patients typically had a most distinguishing adverse event. Examination of the co-occurrences of adverse events in patients led to the identification of potentially interesting adverse event correlations that may be further investigated as well as provide further patient stratification opportunities.
CONCLUSIONS
We have demonstrated the feasibility of a novel approach in pharmacovigilance to stratify patients based on fine-grained adverse event profiles, which also makes it possible to identify adverse event correlations. Used on larger data sets, this data-driven method has the potential to reveal unknown patterns concerning adverse event occurrences.
PubMed: 25249979
DOI: 10.3389/fphys.2014.00332 -
Brain & Spine 2022Adverse events in surgery are a relevant cause of costs, disability, or death, and their incidence is a key quality indicator that plays an important role in the future...
INTRODUCTION
Adverse events in surgery are a relevant cause of costs, disability, or death, and their incidence is a key quality indicator that plays an important role in the future of health care. In neurosurgery, little is known about the frequency of adverse events and the contribution of human error.
RESEARCH QUESTION
To determine the incidence, nature and severity of adverse events in neurosurgery, and to investigate the contribution of human error.
MATERIAL AND METHODS
Prospective observation of all adverse events occurring at an academic neurosurgery referral center focusing on neuro-oncology, cerebrovascular and spinal surgery. All 4176 inpatients treated between September 2019 and September 2020 were included. Adverse events were recorded daily and their nature, severity and a potential contribution of human error were evaluated weekly by all senior neurosurgeons of the department.
RESULTS
25.0% of patients had at least one adverse event. In 25.9% of these cases, the major adverse event was associated with human error, mostly with execution (18.3%) or planning (5.6%) deficiencies. 48.8% of cases with adverse events were severe (≥SAVES-v2 grade 3). Patients with multiple adverse events (8.6%) had more severe adverse events (67.6%). Adverse events were more severe in cranial than in spinal neurosurgery (57.6 vs. 39.4%).
DISCUSSION AND CONCLUSION
Adverse events occur frequently in neurosurgery. These data can serve as benchmarks when discussing quality-based accreditation and reimbursement in upcoming health care reforms.The high frequency of human performance deficiencies contributing to adverse events shows that there is potential to further eliminate avoidable patient harm.
PubMed: 36248119
DOI: 10.1016/j.bas.2021.100853 -
Vaccines Jun 2022In December 2020, the U.S. Food and Drug Administration licensed COVID-19 vaccines for emergency use authorization. We investigated the ocular adverse event reports in...
In December 2020, the U.S. Food and Drug Administration licensed COVID-19 vaccines for emergency use authorization. We investigated the ocular adverse event reports in patients reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination against COVID-19. We searched the VAERS database for U.S. reports among persons who received COVID-19 vaccines between December 2020 and December 2021. Our goal was to analyze and quantify the ocular adverse events submitted to VAERS to provide clinicians and researchers with a broader view of these ocular side effects. During the analysis period, VAERS received 55,313 adverse event reports and, after data cleaning, 6688 reports met the inclusion criteria. Note that 2229 (33.33%) adverse events were classified as cases of eyelid swelling, ocular hyperemia and conjunctivitis, 1785 (26.69%) as blurred vision and 1322 (19.77%) as visual impairment. Females accounted for 73.8% of adverse event reports and the age group between 40 and 59 years had the most frequent adverse events. A higher proportion of these adverse events reported to VAERS was linked with the Janssen and Moderna COVID-19 vaccines. At the time of vaccination, a high proportion of patients reported conditions like allergies, hypertension, diabetes, thyroid disease, vascular and other autoimmune diseases. A review of these data suggests a possible association between COVID-19 vaccines and ocular adverse events. Physicians are cautioned not only to be aware of this potential problem, but to check any underlying patient conditions, and to carefully document in VAERS within a few weeks of vaccination. Future COVID-19 vaccine safety studies in healthy subjects would help clarify the vaccine's safety profile.
PubMed: 35746549
DOI: 10.3390/vaccines10060941 -
Frontiers in Pharmacology 2024Ticagrelor is a commonly used antiplatelet agent, but due to the stringent criteria for trial population inclusion and the limited sample size, its safety profile has...
BACKGROUND
Ticagrelor is a commonly used antiplatelet agent, but due to the stringent criteria for trial population inclusion and the limited sample size, its safety profile has not been fully elucidated.
METHOD
We utilized OpenVigil 2.1 to query the FDA Adverse Event Reporting System database and retrieved reports by the generic name "ticagrelor" published between 1 October 2010 and 31 March 2023. Adverse drug events (ADEs) were classified and described according to the preferred terms and system organ classes in the Medical Dictionary of Regulatory Activity. Proportional reporting ratio (PRR), reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) were used to detect signals.
RESULTS
The number of ADE reports with ticagrelor as the primary suspect drug was 12,909. The top three ADEs were dyspnea [1824 reports, ROR 7.34, PRR 6.45, information component (IC) 2.68], chest pain (458 reports, ROR 5.43, PRR 5.27, IC 2.39), and vascular stent thrombosis (406 reports, ROR 409.53, PRR 396.68, IC 8.02). The highest ROR, 630.24, was found for "vascular stent occlusion". Cardiac arrest (137 reports, ROR 3.41, PRR 3.39, IC 1.75), atrial fibrillation (99 reports, ROR 2.05, PRR 2.04, IC 1.03), asphyxia (101 reports, ROR 23.60, PRR 23.43, IC 4.51), and rhabdomyolysis (57 reports, ROR 2.75, PRR 2.75, IC 1.45) were suspected new adverse events of ticagrelor.
CONCLUSION
The FAERS database produced potential signals associated with ticagrelor that have not been recorded in the package inserts, such as cardiac arrest, atrial fibrillation, asphyxia, and rhabdomyolysis. Further clinical surveillance is needed to quantify and validate potential hazards associated with ticagrelor-related adverse events.
PubMed: 38655177
DOI: 10.3389/fphar.2024.1251961 -
Journal of Patient Safety Dec 2020Reporting of adverse and near miss events are essential to identify system level targets to improve patient safety. Resident physicians historically report few events...
OBJECTIVES
Reporting of adverse and near miss events are essential to identify system level targets to improve patient safety. Resident physicians historically report few events despite their role as front-line patient care providers. We sought to evaluate barriers to adverse event reporting in an effort to improve reporting. Our main outcomes were as follows: resident attitudes about event reporting and the frequency of event reporting before and after interventions to address reporting barriers.
METHODS
We surveyed first year residents regarding barriers to adverse event reporting and used this input to construct a fishbone diagram listing barriers to reporting. Barriers were addressed, and resident event reporting was compared before and after efforts were made to reduce obstacles to reporting.
RESULTS
First year residents (97%) recognized the importance of submitting event reports; however, the majority (85%) had not submitted an event report in the first 6 months of residency. Only 7% of residents specified that they had not witnessed an adverse event in 6 months, whereas one third had witnessed 10 or more events. The main barriers were as follows: lack of knowledge about how to submit events (38%) and lack of time to submit reports (35%). After improving resident education around event reporting and simplifying the reporting process, resident event reporting increased 230% (68 to 154 annual reports, P = 0.025).
CONCLUSIONS
We were able to significantly increase resident event reporting by educating residents about adverse events and near misses and addressing the primary barriers to event reporting. Moving forward, we will continue annual resident education about patient safety, focus on improving feedback to residents who submit reports, and empower senior residents to act as role models to junior residents in patient safety initiatives.
Topics: Humans; Medical Errors; Patient Safety; Risk Management; Surveys and Questionnaires
PubMed: 29028690
DOI: 10.1097/PTS.0000000000000333