-
Current Urology Reports May 2024In this review, we aim to summarize the impact of surgical complications and adverse events on surgeons, including psychiatric illnesses. We evaluate current programs to... (Review)
Review
PURPOSE OF REVIEW
In this review, we aim to summarize the impact of surgical complications and adverse events on surgeons, including psychiatric illnesses. We evaluate current programs to develop trainee well-being and investigate research within the field of urology.
RECENT FINDINGS
Surgical complications and adverse events affect all surgeons, including surgical trainees. Research estimates that 80% of healthcare professionals have been involved in an event that affected them emotionally. These events can affect physicians in many ways, ranging from negatively impacting their quality of life to leading to psychiatric disorders such as acute stress reactions and post-traumatic stress disorder. Unfortunately, there is no standardized preparation to equip trainees to manage and rebound from the profound emotional impact of surgical complications. Data in this realm is insufficient, especially in urology, and we need more research in order to better evaluate emotional implications of complications on trainees and how we can prepare trainees to handle them.
PubMed: 38797800
DOI: 10.1007/s11934-024-01207-7 -
Journal of Feline Medicine and Surgery Nov 2023This case series describes five cats with cutaneous adverse events after subcutaneous administration of frunevetmab, a felinised anti-nerve growth factor monoclonal...
CASE SERIES SUMMARY
This case series describes five cats with cutaneous adverse events after subcutaneous administration of frunevetmab, a felinised anti-nerve growth factor monoclonal antibody, including histopathological findings in one case. All cats displayed moderate to severe pruritus resulting in self-trauma to the neck and/or head, causing lesions ranging from superficial dermatitis to alopecia and ulcerations. There were no reactions at the injection sites. In one cat, clinical signs developed after the second frunevetmab dose the cat received, with no reaction noted after the first dose. For the remaining cats, clinical signs were observed after their first dose of frunevetmab. The onset of the first episode of pruritus and self-trauma was 3-18 days after the most recent frunevetmab injection. Three cats had one or more additional frunevetmab injections after the original adverse event and all had subsequent reactions. Subsequent reactions were either similar in time frame or occurred more rapidly, with similar or more severe pruritus compared with the original reactions. Treatments and outcomes varied between cases.
RELEVANCE AND NOVEL INFORMATION
Frunevetmab is a novel, monthly injectable monoclonal antibody for the management of pain associated with osteoarthritis in cats. This is the first published report detailing the nature of cutaneous adverse events associated with this treatment, and the first report of the histopathological findings.
Topics: Animals; Cats; Pruritus; Antibodies, Monoclonal; Cat Diseases
PubMed: 37975186
DOI: 10.1177/1098612X231198416 -
Paediatrics & Child Health Aug 2023It is well established that adverse drug events are frequent in paediatric hospital practice. The objective of this study is to systematically quantify and report the...
BACKGROUND AND OBJECTIVES
It is well established that adverse drug events are frequent in paediatric hospital practice. The objective of this study is to systematically quantify and report the incidence of harmful adverse drug events across our institution and to identify predominant medications and error types.
METHODS
We prospectively compiled a validated medication safety database for paediatric inpatients within our institution over a three-and-a-half-year period. All incidences of apparent patient harm relating to medication error were investigated and analyzed to determine veracity, severity of harm, phase of medication process, error type, causative medication, and contributory factors enabling each event.
RESULTS
We identified 59 harmful adverse drug events, with an overall rate of 15.5 per 10 patient bed days. Most events occurred during administration ( = 27) and prescribing ( = 26) phases. Almost half of all harm (49%) was associated with opioids; a broad range of medication classes accounted for other harm. Harmful events occurred in 7.3 per 10 administrations of morphine and 13.3 per 10 administrations of hydromorphone. Wrong dose was the most frequently encountered error type.
CONCLUSIONS
This is the first study to quantify harmful adverse drug events in paediatric hospital practice. Our prospective analysis and compilation of harmful medication errors in paediatric hospital practice, reported with denominators of opioid administrations, and patient bed days, is a new standard for comparison in the long-discussed problem of paediatric harmful adverse drug events. By focusing on identified problematic drugs, error types, and contributory factors, we identify opportunities for interventions, error prevention and harm reduction.
PubMed: 37484044
DOI: 10.1093/pch/pxac132 -
Clinical and Experimental Hypertension... Dec 2023Major adverse cardiovascular events (MACE) are common in patients with hypertension and are associated with higher mortality.
BACKGROUND
Major adverse cardiovascular events (MACE) are common in patients with hypertension and are associated with higher mortality.
METHODS
This study aimed to observe the incidence of MACE in hypertensive patients and the correlation between the electrocardiogram (ECG) T-wave abnormalities and echocardiographic changes. This retrospective cohort study analyzed the incidence of adverse cardiovascular events and changes in echocardiographic features in 430 hypertensive patients admitted to Zhongnan Hospital of Wuhan University from January 2016 to January 2022. Patients were grouped according to a diagnosis of electrocardiographic T-wave abnormalities.
RESULTS
Compared with the normal T-wave group, the incidence of adverse cardiovascular events was significantly higher in hypertensive patients with abnormal T-wave (141 [54.9%] vs 120 [69.4%], x^2 = 9.113, = .003). However, Kaplan-Meier survival curve showed that no survival advantage was observed in the normal T-wave group at all in the hypertensive patients ( = .83). Echocardiographic values associated with cardiac structural markers, including ascending aorta diameter (AAO), left atrial diameter (LA), and interventricular septal thickness (IVS), were significantly higher in the group with abnormal T-wave than those in the group with normal T-wave at baseline and follow-up ( <.05 for all). In addition, in an exploratory Cox regression analysis model stratified by clinical characteristics of hypertensive patients, the forest plot indicated that the variables, including the age (>65 years), hypertension history (>5 years), premature atrial beats, and severe valvular regurgitation were significantly associated with adverse cardiovascular events ( <.05).
CONCLUSION
Hypertensive patients with abnormal T-wave show a higher incidence of adverse cardiovascular events. The values of cardiac structural markers were significantly higher in the group with abnormal T-wave.
Topics: Humans; Aged; Retrospective Studies; Echocardiography; Hypertension; Electrocardiography; Aorta
PubMed: 36863333
DOI: 10.1080/10641963.2023.2185252 -
Frontiers in Pharmacology 2023Mepolizumab is primarily used in the treatment of asthma, eosinophilic granulomatosis with polyangiitis, eosinophilia syndrome, and chronic rhinitis with nasal polyps....
Mepolizumab is primarily used in the treatment of asthma, eosinophilic granulomatosis with polyangiitis, eosinophilia syndrome, and chronic rhinitis with nasal polyps. The information about its adverse drug reactions is mainly derived from clinical trials, and there is a shortage of real-world studies with extensive sample sizes. In this study, the U.S. FDA's Adverse Event Reporting System (FAERS) database was analyzed to evaluate the side effects of mepolizumab. A total of 18,040 reports of mepolizumab-associated adverse events were identified from the FDA Adverse Event Reporting System database. Multiple disproportionality analysis algorithms were used to determine the significance of these AEs. The study identified 198 instances of mepolizumab-induced AEs, including some important AEs not mentioned in the product labeling. The time to onset of adverse reactions was also analyzed, with a median time of 109 days. Most AEs occurred within the first month of mepolizumab use, but some may still occur after 1 year of treatment. Gender-specific analysis showed different high-risk AEs for females (digestive and neurological side effects) and males (serious adverse effects leading to hospitalization and death). The findings mentioned provide valuable insights on optimizing the use of mepolizumab, enhancing its effectiveness, and minimizing potential side effects. This information will greatly contribute to the practical implementation of the drug in clinical settings.
PubMed: 38186645
DOI: 10.3389/fphar.2023.1320458 -
International Journal of Clinical... Dec 2023Malignant skin tumors are adverse events of concern regarding Janus kinase (JAK) inhibitors.
BACKGROUND
Malignant skin tumors are adverse events of concern regarding Janus kinase (JAK) inhibitors.
AIM
This study aimed to evaluate the association between JAK inhibitors and adverse events of malignant skin tumors, and to characterize the main features.
METHOD
Data (2012-2021) were collected using the US Food and Drug Administration Adverse Event Reporting System (FAERS). Adverse event cases of JAK inhibitors as the primary suspected drug were extracted for further analysis. Disproportionality analysis evaluated the association between JAK inhibitors and malignant skin tumor events by estimating the reporting odds ratio (ROR) and the information component (IC) with 95% confidence intervals (95% CI).
RESULTS
A total of 142,673 cases with JAK inhibitors as a primary suspected drug were collected, including 1400 malignant skin tumor events. Ruxolitinib, upadacitinib, tofacitinib, and baricitinib were included in the disproportionality analysis. Three JAK inhibitors were associated with malignant skin tumor events, namely ruxolitinib (ROR 5.40, 95% CI 5.03-5.81; IC 2.39, 95% CI 2.14-2.62), upadacitinib (ROR 4.79, 95% CI 4.03-5.71; IC 2.24, 95% CI 1.62-2.77), and tofacitinib (ROR 1.67, 95% CI 1.53-1.83; IC 0.73, 95% CI 0.43-1.02). The median time to onset time was 378.5 days.
CONCLUSION
We found association between malignant skin tumors and ruxolitinib, upadacitinib, and tofacitinib. More attention should be paid to these events when prescribing JAK inhibitors in clinical practice.
Topics: United States; Humans; Janus Kinase Inhibitors; United States Food and Drug Administration; Databases, Factual; Skin Neoplasms; Adverse Drug Reaction Reporting Systems; Pharmacovigilance
PubMed: 37606843
DOI: 10.1007/s11096-023-01634-5 -
Journal of the American Medical... Dec 2023Apply natural language processing (NLP) to Amazon consumer reviews to identify adverse events (AEs) associated with unapproved over the counter (OTC) homeopathic drugs...
Using natural language processing to characterize and predict homeopathic product-associated adverse events in consumer reviews: comparison to reports to FDA Adverse Event Reporting System (FAERS).
OBJECTIVE
Apply natural language processing (NLP) to Amazon consumer reviews to identify adverse events (AEs) associated with unapproved over the counter (OTC) homeopathic drugs and compare findings with reports to the US Food and Drug Administration Adverse Event Reporting System (FAERS).
MATERIALS AND METHODS
Data were extracted from publicly available Amazon reviews and analyzed using JMP 16 Pro Text Explorer. Topic modeling identified themes. Sentiment analysis (SA) explored consumer perceptions. A machine learning model optimized prediction of AEs in reviews. Reports for the same time interval and product class were obtained from the FAERS public dashboard and analyzed.
RESULTS
Homeopathic cough/cold products were the largest category common to both data sources (Amazon = 616, FAERS = 445) and were analyzed further. Oral symptoms and unpleasant taste were described in both datasets. Amazon reviews describing an AE had lower Amazon ratings (X2 = 224.28, P < .0001). The optimal model for predicting AEs was Neural Boosted 5-fold combining topic modeling and Amazon ratings as predictors (mean AUC = 0.927).
DISCUSSION
Topic modeling and SA of Amazon reviews provided information about consumers' perceptions and opinions of homeopathic OTC cough and cold products. Amazon ratings appear to be a good indicator of the presence or absence of AEs, and identified events were similar to FAERS.
CONCLUSION
Amazon reviews may complement traditional data sources to identify AEs associated with unapproved OTC homeopathic products. This study is the first to use NLP in this context and lays the groundwork for future larger scale efforts.
Topics: United States; Humans; Adverse Drug Reaction Reporting Systems; Natural Language Processing; Drug-Related Side Effects and Adverse Reactions; Software; United States Food and Drug Administration; Cough
PubMed: 37847653
DOI: 10.1093/jamia/ocad197 -
Expert Opinion on Drug Safety Jan 2024Four CGRP Monoclonal Antibodies (mAbs) have been approved for migraine prophylaxis by the Food and Drug Administration (FDA) since 2018. However, there are concerns...
BACKGROUND
Four CGRP Monoclonal Antibodies (mAbs) have been approved for migraine prophylaxis by the Food and Drug Administration (FDA) since 2018. However, there are concerns about the safety of these four drugs for real-world use.
OBJECTIVE
To compare the adverse event profiles of four CGRP-mAbs with FAERS data.
METHODS
The study was based on records from the FAERS database. Only reports containing one of the active ingredients with CGRP-mAbs were included in this study. Disproportionality analyses including but not limited to reporting odds ratio (ROR) and information components (IC) were conducted to identify drug-AE associations.
RESULTS
In total, 58110 reports were identified for CGRP-mAbs. 80 overlapping signals were disproportionately reported. They affected a range of organs and systems, including the gastrointestinal and cardiovascular systems, skin, and hair. Additionally, the rare cardiovascular adverse events were significantly different among the four CGRP-mAbs.
CONCLUSION
We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.
Topics: United States; Humans; Antibodies, Monoclonal; Calcitonin Gene-Related Peptide; Drug-Related Side Effects and Adverse Reactions; United States Food and Drug Administration; Adverse Drug Reaction Reporting Systems
PubMed: 37720989
DOI: 10.1080/14740338.2023.2250720 -
International Journal of Medical... Dec 2023Identifying patient safety events using electronic health records (EHRs) and automated machine learning-based detection methods can help improve the efficiency and... (Review)
Review
INTRODUCTION
Identifying patient safety events using electronic health records (EHRs) and automated machine learning-based detection methods can help improve the efficiency and quality of healthcare service provision.
OBJECTIVE
This study aimed to systematically review machine learning-based methods and techniques, as well as their results for patient safety event management using EHRs.
METHODS
We reviewed the studies that focused on machine learning techniques, including automatic prediction and detection of patient safety events and medical errors through EHR analysis to manage patient safety events. The data were collected by searching Scopus, PubMed (Medline), Web of Science, EMBASE, and IEEE Xplore databases.
RESULTS
After screening, 41 papers were reviewed. Support vector machine (SVM), random forest, conditional random field (CRF), and bidirectional long short-term memory with conditional random field (BiLSTM-CRF) algorithms were mostly applied to predict, identify, and classify patient safety events using EHRs; however, they had different performances. BiLSTM-CRF was employed in most of the studies to extract and identify concepts, e.g., adverse drug events (ADEs) and adverse drug reactions (ADRs), as well as relationships between drug and severity, drug and ADEs, drug and ADRs. Recurrent neural networks (RNN) and BiLSTM-CRF had the best results in detecting ADEs compared to other patient safety events. Linear classifiers and Naive Bayes (NB) had the highest performance for ADR detection. Logistic regression had the best results in detecting surgical site infections. According to the findings, the quality of articles has non-significantly improved in recent years, but they had low average scores.
CONCLUSIONS
Machine learning can be useful in automatic detection and prediction of patient safety events. However, most of these algorithms have not yet been externally validated or prospectively tested. Therefore, further studies are required to improve the performance of these automated systems.
Topics: Humans; Electronic Health Records; Bayes Theorem; Patient Safety; Machine Learning; Algorithms
PubMed: 37837710
DOI: 10.1016/j.ijmedinf.2023.105246 -
JACC. Cardiovascular Interventions Jul 2023Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). (Observational Study)
Observational Study
BACKGROUND
Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI).
OBJECTIVES
The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study.
METHODS
We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization.
RESULTS
From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs -21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex.
CONCLUSIONS
In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392).
Topics: Humans; Male; Female; Coronary Artery Disease; Percutaneous Coronary Intervention; Prospective Studies; Treatment Outcome; Myocardial Infarction; Stroke; Risk Factors
PubMed: 37409991
DOI: 10.1016/j.jcin.2023.04.036