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The Journal of Hand Surgery, European... Feb 2024Complications are a recognized hazard of surgery. The term is confusing; it has multiple meanings, including surgical error and adverse surgical outcomes. I propose the...
Complications are a recognized hazard of surgery. The term is confusing; it has multiple meanings, including surgical error and adverse surgical outcomes. I propose the latter two terms are used. Grading of 'complications' is difficult but made easier by grading errors and outcomes separately, though they are not always linked. The exact grades are not established.Error avoidance requires efforts at a personal (surgeon) level, including training, learning and preparation, and at a systems level. Understanding human factors is important.The perspective of patients about adverse outcomes is not well understood. There is evidence that, unsurprisingly, patient perspectives may be different to surgeon perspectives. There are a range of surgeon responses to error and adverse outcomes; many are negative. These need to be understood better in order to protect patients and surgeons in the immediate aftermath and in the potentially prolonged 'recovery time', both for patients and surgeons. V.
Topics: Humans; Surgeons; Medical Errors; Postoperative Complications
PubMed: 38315132
DOI: 10.1177/17531934231206317 -
Frontiers in Pharmacology 2023Cholangiocarcinoma (CCA) is a highly lethal and aggressive epithelial tumor of the hepatobiliary system. A poor prognosis, propensity for relapse, low chance of cure...
Cholangiocarcinoma (CCA) is a highly lethal and aggressive epithelial tumor of the hepatobiliary system. A poor prognosis, propensity for relapse, low chance of cure and survival are some of its hallmarks. Pemigatinib, the first targeted treatment for CCA in the United States, has been demonstrated to have a significant response rate and encouraging survival data in early-phase trials. The adverse events (AEs) of pemigatinib must also be determined. To understand more deeply the safety of pemigatinib in the real world through data-mining of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Disproportionality analysis was employed in a retrospective pharmacovigilance investigation to identify the AEs linked to pemigatinib use as signals. Data were collected between 1 January 2020 to 30 June 2022. Four data-mining methods (proportional reporting odds ratio; proportional reporting ratio; Bayesian confidence propagation neural networks of information components; empirical Bayes geometric means) were used to calculate disproportionality. A total of 203 cases using pemigatinib as the prime-suspect medication were found in our search, which involved 99 preferred terms (PTs). Thirteen signals of pemigatinib-induced AEs in seven System Organ Classes were detected after confirming the four algorithms simultaneously. Nephrolithiasis was an unexpected significant AE not listed on the drug label found in our data-mining. Comparison of the differences between pemigatinib and platinum drugs in terms of 33 PTs revealed that 13 PTs also met the criteria of the four algorithms. Ten of these PTs were identical to those compared with all other drugs, in which (excluding a reduction in phosphorus in blood) other PT signal values were higher than those of all other drugs tested. However, comparison of the differences between pemigatinib and infigratinib in terms of the 33 PTs revealed no significant signals in each algorithm method. Some significant signals were detected between pemigatinib use and AEs. PTs with apparently strong signals and PTs not mentioned in the label should be taken seriously.
PubMed: 37554985
DOI: 10.3389/fphar.2023.1194545 -
Healthcare (Basel, Switzerland) Feb 2024The level of safety in healthcare units is mainly characterized by the occurrence of medical adverse events. The aim of the study was to present the experiences of...
The level of safety in healthcare units is mainly characterized by the occurrence of medical adverse events. The aim of the study was to present the experiences of reporting clinical adverse events and the perceptions of nurses working in internal medicine wards, surgical wards and midwives on these issues. The cross-sectional survey was conducted from October 2022 to April 2023. The study used the Author's Survey Questionnaire and sampling by assessment was applied. The study included nurses working in internal medicine wards and surgical wards as well as midwives at nine hospitals in a large provincial city in Poland, amounting to 745 participants. A one-way analysis of variance ANOVA and a post-hoc test (Fisher's NIR) were used. The significance level () did not exceed 0.05. Nurses working in surgical wards, internal medicine wards and midwives thought that clinical adverse events should be reported, and perceived this as an important and useful activity in ensuring patient safety. The most common adverse events reported by respondents were falls F(2.742) = 52.07; = 0.001, bedsores F(2.742) = 19.62; = 0.001, patient disappearances F(2.742) = 3.98; = 0.019, and hospital-acquired infections F(2.742) = 3.88; = 0.021. The most frequently selected factors influencing the abandonment of adverse event reporting were excessively complex paperwork, no or little harm to the patient or a fear of the negative consequences. The study suggests that an important way to overcome the barriers to nurses and midwives reporting adverse events would be to create a supportive atmosphere in which they could report errors and the reasons for them honestly and without fear, and to improve the way adverse events are reported at the personal and institutional levels.
PubMed: 38391835
DOI: 10.3390/healthcare12040460 -
Artificial Intelligence in Medicine Sep 2023Clinical event sequences consist of hundreds of clinical events that represent records of patient care in time. Developing accurate predictive models of such sequences...
Clinical event sequences consist of hundreds of clinical events that represent records of patient care in time. Developing accurate predictive models of such sequences is of a great importance for supporting a variety of models for interpreting/classifying the current patient condition, or predicting adverse clinical events and outcomes, all aimed to improve patient care. One important challenge of learning predictive models of clinical sequences is their patient-specific variability. Based on underlying clinical conditions, each patient's sequence may consist of different sets of clinical events (observations, lab results, medications, procedures). Hence, simple population-wide models learned from event sequences for many different patients may not accurately predict patient-specific dynamics of event sequences and their differences. To address the problem, we propose and investigate multiple new event sequence prediction models and methods that let us better adjust the prediction for individual patients and their specific conditions. The methods developed in this work pursue refinement of population-wide models to subpopulations, self-adaptation, and a meta-level model switching that is able to adaptively select the model with the best chance to support the immediate prediction. We analyze and test the performance of these models on clinical event sequences of patients in MIMIC-III database.
Topics: Humans; Electronic Health Records; Databases, Factual; Learning
PubMed: 37673563
DOI: 10.1016/j.artmed.2023.102620 -
BMC Gastroenterology Sep 2023Validated, accepted grading tools for preprocedural complexity assessment in ERCP are lacking. We therefore created a grading system for ERCP based on the classification...
BACKGROUND
Validated, accepted grading tools for preprocedural complexity assessment in ERCP are lacking. We therefore created a grading system for ERCP based on the classification used by the American Society for Gastrointestinal Endoscopy (ASGE).
METHODS
Data on ERCP adverse events (AE) and success were collected in a multicenter, prospective uncontrolled study. Multiple logistic regressions were applied to success and AEs in accordance with the ASGE classification. Each procedure suggested by ASGE was tested against different outcomes. Results were used to create a score and were evaluated in a control cohort.
RESULTS
16,327 ERCPs were documented in 27 centers. Analysis of ASGE categorization (10,904 cases) showed that this model fails to adequately predict parameters of complexity; only for cardiopulmonary AEs and perforation was no significant variance evident. Depending on the specific clinical circumstances, probability of success of the intervention sometimes varied significantly in risk, implying a twofold score, one part for probability of success and one for risk. A split score with three levels each was designed and tested in a validation cohort (5,423 procedures). Achieving therapeutic targets / post-ERCP pancreatitis could be correctly predicted in 87.0%/95.3%.
CONCLUSIONS
Grading ERCP success and AEs have to be considered independently. Onefold grading systems appear incomplete and unable to provide an adequate classification of severity. SASE (Success and Adverse Event Score in Endoscopic Retrograde Cholangiopancreatography) was created to incorporate these findings. Showing high predictive value, this score could be a potent tool for planning ERCP and training in endoscopy.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Prospective Studies; Pancreatitis; Probability; Research Design
PubMed: 37715151
DOI: 10.1186/s12876-023-02942-w -
Journal of Atherosclerosis and... Apr 2024Past observational studies have reported on the association between antipsychotic drugs and venous thromboembolism (VTE); however, the conclusions remain controversial,...
Association of Antipsychotic Drugs with Venous Thromboembolism: Data Mining of Food and Drug Administration Adverse Event Reporting System and Mendelian Randomization Analysis.
AIMS
Past observational studies have reported on the association between antipsychotic drugs and venous thromboembolism (VTE); however, the conclusions remain controversial, and its mechanisms are yet to be fully understood. Thus, in this study, we aim to determine the associations of antipsychotic drugs with VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), and their potential mechanisms.
METHODS
We first mined the adverse event signals of VTE, DVT, and PE caused by antipsychotic drugs in Food and Drug Administration Adverse Event Reporting System (FAERS). Next, we used two-sample Mendelian randomization (MR) method to investigate the association of antipsychotic drug target gene expression with VTE, DVT, and PE, using single-nucleotide polymorphisms as genetic instruments. We not only used the expression of all antipsychotic drug target genes as exposure to perform MR analyses but also analyzed the effect of single target gene expression on the outcomes.
RESULTS
In the FAERS, 1694 cases of VTE events were reported by 16 drugs. However, using the MR approach, no significant association was determined between the expression of all antipsychotic target genes and VTE, DVT, or PE, either in blood or brain tissue. Although the analysis of single gene expression data showed that the expression of nine genes was associated with VTE events, these targets lacked significant pharmacological action.
CONCLUSIONS
Adverse event mining results have supported the claim that antipsychotic drugs can increase the risk of VTE. However, we failed to find any genetic evidence for this causal association and potential mechanisms. Thus, vigilance is still needed for antipsychotic drug-related VTE despite the limited supporting evidence.
Topics: United States; Humans; Venous Thromboembolism; Antipsychotic Agents; Mendelian Randomization Analysis; United States Food and Drug Administration; Pulmonary Embolism; Data Mining
PubMed: 38030236
DOI: 10.5551/jat.64461 -
European Journal of Medical Research Nov 2023There have been massive studies to develop an effective vaccine against SARS-CoV-2 which fortunately led to manage the recent pandemic, COVID-19. According to the quite... (Review)
Review
There have been massive studies to develop an effective vaccine against SARS-CoV-2 which fortunately led to manage the recent pandemic, COVID-19. According to the quite rapidly developed vaccines in a fast window time, large investigations to assess the probable vaccine-related adverse events are crucially required. COVID-19 vaccines are available of different platforms and the primary clinical trials results presented acceptable safety profile of the approved vaccines. Nevertheless, the long-term assessment of the adverse events or rare conditions need to be investigated. The present systematic review, aimed at classification of probable vaccine-related unsolicited adverse events in Iranian population through the data collection of the published case report studies.The related published case reports were explored via PubMed, Web of Science and Google scholar according to the available published data up to 14 Dec, 2022 using PRISMA guideline. Out of 437 explored studies, the relevant data were fully investigated which totally led to 40 studies, including 64 case reports with a new onset of a problem post-vaccination. The cases were then classified according to the various items, such as the type of adverse event and COVID-19 vaccines.The reported COVID-19 vaccines in the studied cases included BBIBP-CorV, ChAdOx1-S, Sputnik V and COVAXIN. The results showed that the adverse events presented in 8 different categories, including cutaneous involvements in 43.7% (n = 28), neurologic problems (n = 16), blood/vessel involvement (n = 6), cardiovascular involvement (n = 5), ocular disorders (n = 4), liver disorder/failure (n = 2), graft rejection (n = 2) and one metabolic disorder. Notably, almost 60% of the cases had no comorbidities. Moreover, the obtained data revealed nearly half of the incidences occurred after the first dose of injection and the median duration of improvement after the symptom was 10 days (range: 2-120). In addition, 73% of all the cases were either significantly improved or fully recovered. Liver failure following ChAdOx1-S vaccination was the most serious vaccine adverse event which led to death in two individuals with no related medical history.Although the advantages of COVID-19 vaccination is undoubtedly significant, individuals including with a history of serious disease, comorbidities and immunodeficiency conditions should be vaccinated with the utmost caution. This study provides a comprehensive overview and clinical implications of possible vaccine-related adverse events which should be considered in further vaccination strategies. Nevertheless, there might be a bias regarding potential under-reporting and missing data of the case reports included in the present study. Although the reported data are not proven to be the direct vaccination outcomes and could be a possible immune response over stimulation, the people the population with a medium/high risk should be monitored after getting vaccinated against COVID-19 of any platforms. This could be achieved by a carefull attention to the subjects ' medical history and also through consulting with healthcare providers before vaccination.
Topics: Humans; COVID-19; COVID-19 Vaccines; Iran; SARS-CoV-2; Vaccination; Case Reports as Topic
PubMed: 38008729
DOI: 10.1186/s40001-023-01531-7 -
Frontiers in Pharmacology 2023To mine the adverse drug event (ADE) signals of upadacitinib based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to provide...
To mine the adverse drug event (ADE) signals of upadacitinib based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to provide a reference for the safe clinical use of the drug. The ADE data for upadacitinib from Q1 2004 to Q1 2023 in the FAERS database were retrieved, and data mining was performed using the reporting odds ratio and proportional reporting ratio. A total of 21,213 ADE reports for the primary suspect drug upadacitinib were obtained, involving 444 ADEs. Patients aged ≥60 years (21.48%) and female (70.11%) patients were at a higher risk of ADEs with upadacitinib. After data cleaning, 182 ADE signals from 19 system organ classes (SOCs) were obtained. Six of these SOCs that occurred more frequently and were not mentioned in the drug labeling information included renal and urinary system (1.09%), reproductive and breast diseases (1.14%), ear and labyrinth disorders (0.57%), psychiatric disease (0.57%), blood and lymphatic system disorders (0.57%), and endocrine disorders (0.57%). The top ten most frequent ADE signals reported for upadacitinib were mainly related to: infections and infestations (7), investigations (2), and skin and subcutaneous tissue disorders (1). The top 10 ADEs in signal intensity ranking were lip neoplasm, ureteral neoplasm, eczema herpeticum, vulvar dysplasia, mediastinum neoplasm, eosinopenia, herpes zoster cutaneous disseminated, eye ulcer, acne cystic, and infection. The top 10 high-frequency events leading to serious adverse events were urinary tract infection (2.74%), herpes zoster (1.63%), diverticulitis (1.19%), bronchitis (0.68%), nasopharyngitis (0.68%), localised infection (0.66%), nephrolithiasis (0.66%), pulmonary thrombosis (0.66%), blood cholesterol increased (0.55%), and pneumonia (0.53%). Clinicians should be vigilant to upadacitinib-induced events in systems not covered in the drug labeling information and to new and highly signaled ADEs to ensure the safe and effective use of upadacitinib.
PubMed: 37663269
DOI: 10.3389/fphar.2023.1200254 -
Drug Safety Sep 2023Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy in women with hormone receptor-positive, human epidermal growth factor receptor...
BACKGROUND AND OBJECTIVE
Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Because of the limitations of clinical trials, which are not representative of large real-world populations, rare events and long-term safety concerns cannot be detected. The current study aimed to evaluate the adverse events of abemaciclib through data mining of the Food and Drug Administration Adverse Event Reporting System (FAERS).
METHODS
Reporting odds ratio and Bayesian confidence propagation neural network of information components were used to quantify the adverse event signals of abemaciclib from the third quarter of 2017 to the first quarter of 2022. Serious and non-serious cases were compared using the Mann-Whitney U test or Chi-squared test, and clinical priority was assigned to signals by scoring (range 0-10 points) five features using a rating scale.
RESULTS
A total of 6125 reports of abemaciclib as the "primary suspected" and 72 significant adverse events of abemaciclib were identified. Common adverse events, such as diarrhea, neutropenia, alanine transaminase, aspartate transaminase, and serum creatinine increases, and other adverse events, including thrombosis, deep vein thrombosis, pulmonary embolism, interstitial lung disease, and pneumonitis were of high concern. Of note, 17 preferred terms were classified as unexpected adverse events that uncovered in the label. In addition, 1, 26, and 45 adverse events were identified as strong, moderate, and weak clinical priorities. The median time to onset for strong, moderate, and weak clinical priority signals was 49, 22, and 28 days, respectively. All of the disproportionality signals had early failure type features, suggesting that adverse events of abemaciclib gradually decreased over time.
CONCLUSIONS
The discovery of disproportionality signals could potentially prompt improved awareness of toxicities for abemaciclib, and the results of time to onset, serious and non-serious reports, and clinical priority analyses provided some supporting evidence for clinicians to manage adverse events.
Topics: United States; Humans; Female; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Bayes Theorem; Adverse Drug Reaction Reporting Systems; Breast Neoplasms; United States Food and Drug Administration
PubMed: 37418089
DOI: 10.1007/s40264-023-01334-z -
Annals of Hematology Nov 2023The present study is an overview of systematic reviews focusing on adverse events of antimyeloma treatments. It provides a systematic description of adverse events as... (Review)
Review
The present study is an overview of systematic reviews focusing on adverse events of antimyeloma treatments. It provides a systematic description of adverse events as they are reported in the systematic reviews as well as a critical appraisal of included reviews. We conducted a comprehensive literature search in the most widely used electronic databases looking for systematic reviews that had an adverse event of an antimyeloma treatment intervention as primary outcome. Two independent reviewers conducted selection of included studies and data extraction on predesigned online forms and assessed study quality using AMSTAR 2. Overall corrected covered area (CCA) was calculated to examine the overlap of primary studies across systematic reviews. After screening eligible studies, 23 systematic reviews were included in this overview. Seven reviews with overall CCA of 14.7% examined cardiovascular adverse events of different drugs, including immunomodulatory drugs and proteasome inhibitors (mainly carfilzomib). Nine focused on infections, presenting with overall CCA of 5.8%, each one focused on a different drug or drug class. Three studied thromboembolism in patients treated either with lenalidomide, any immunomodulatory drug, or with daratumumab and had an overall CCA equal to 1.5%. Four more reviews focused on bortezomib-associated neurotoxicity, carfilzomib-associated renal toxicity, or second primary malignancies as an adverse event of lenalidomide or anti-CD38 monoclonal antibody treatment. The quality of included studies as judged by AMSTAR 2 was mostly critically low. Absence of a priori registered protocol and formal assessment of risk of bias of included primary studies were the most common shortcomings. Reporting of antimyeloma drug-associated toxicity is supported by multiple systematic reviews; nevertheless, methodological quality of existing reviews is mostly low.
PubMed: 37935924
DOI: 10.1007/s00277-023-05517-7