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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 -
Clinical and Experimental Vaccine... Sep 2021Adverse effects are noticeable immediately after vaccination, especially when vaccinated to healthy people at the time of vaccination. The vaccine may cause adverse...
PURPOSE
Adverse effects are noticeable immediately after vaccination, especially when vaccinated to healthy people at the time of vaccination. The vaccine may cause adverse events which are very rare but adverse event following immunization surveillance becomes correspondingly more important in a less studied population like India. Hence, there is a need for carrying out a study pertaining to vaccine safety in the pediatric population of age 0-12 years and assessing the events occurring post-vaccination.
MATERIALS AND METHODS
A prospective observational study was conducted in three primary healthcare centers and two tertiary care hospitals for 6 months from April 2016 to September 2016 with a total of 826 children enrolled. Detected adverse events for suspected vaccines were analyzed for causality by the World Health Organization causality assessment instrument. Sex-specific differences in incidences of adverse events were assessed.
RESULTS
The cumulative adverse events were found highest in pentavalent vaccines (510 incidences, 62.04%) followed by the bacillus Calmette-Guérin vaccine (189 incidences, 22.99%). The study didn't reveal any significant association in incidences of adverse events following immunization and sex of the children.
CONCLUSION
Vaccine safety surveillance studies are need of the hour in developing countries to maintain public trust in vaccines, the ultimate objective being to have vaccines with the most favorable benefit-risk profile. The present study discussed the various adverse events following immunization and suggested the absence of any sex-specific difference in incidences of adverse events in children.
PubMed: 34703803
DOI: 10.7774/cevr.2021.10.3.211 -
Medicina (Kaunas, Lithuania) Sep 2022Background and objectives: Procedural sedation for bone marrow examination (BME) and intrathecal chemotherapy (ITC) is necessary for pediatric patients with...
Background and objectives: Procedural sedation for bone marrow examination (BME) and intrathecal chemotherapy (ITC) is necessary for pediatric patients with hematological malignancies. There has been no report on adverse events after discharge from the recovery room. This retrospective study evaluated the types and incidences of delayed adverse events among pediatric patients scheduled for BME or ITC under deep sedation in a single center for 3 years. Materials and Methods: The patients were divided into two groups: inpatients (group I) and outpatients (group O). All patients were managed during the procedures and the recovery period. In total, 10 adverse events were assessed; these occurred 2 h (T1, acute), 12 h (T2, early), and 24 h (T3, delayed) after the procedure. The duration of each adverse event was also recorded and was classified as 2 h (D1), 12 h (D2), or 24 h (D3). The data of 263 patients (147 inpatients and 116 outpatients) who met the inclusion criteria were analyzed. Results: The overall incidence of adverse events was statistically significant difference: 48.3% in group I and 33.6% in group O (p = 0.011). The rates of adverse events at T1 and T2 were significantly different between groups I and O (42.8% vs. 11.2% and 7.5% vs. 20.7%, respectively) (p < 0.001). The adverse events were mostly of D1 or D2 duration in both groups. Patients with a higher proportion of ketamine in a propofol−ketamine mixture had a significantly higher proportion of adverse events at T1 (34.6%), as compared with those with a mixture with a lower proportion of ketamine (21.1%) or propofol alone (17.9%) (p = 0.012). Conclusions: The most common adverse events were dizziness or headache; typically, they did not last longer than 12 h. The propofol-ketamine combination with a higher proportion of ketamine seems to produce more adverse events within 2 h after the procedure. Nevertheless, all sedative types appear safe to use without additional management.
Topics: Child; Emergency Service, Hospital; Hematologic Neoplasms; Humans; Hypnotics and Sedatives; Ketamine; Propofol; Prospective Studies; Retrospective Studies
PubMed: 36143885
DOI: 10.3390/medicina58091208 -
Annals of Surgery May 2017To investigate adverse event free admissions as a potential, patient-centered indicator aligned directly with the goal of patient safety-freedom from harm.
OBJECTIVE
To investigate adverse event free admissions as a potential, patient-centered indicator aligned directly with the goal of patient safety-freedom from harm.
BACKGROUND
Preventable adverse event rates in healthcare could be further reduced. These are generally measured separately, one adverse event at a time. However, this does not reveal whether different patients are affected or the same patients are experiencing multiple events.
METHODS
We examined Medicare inpatient hospital administrative datasets for 2009 to 2011, processed using standard criteria. Events were (i) death within 30 days, (ii) unplanned readmissions within 30 days, (iii) long length of stay, (iv) healthcare acquired infections, and (v) established patient safety indicators not present on admission. We defined adverse event free admissions as those without record of any of these events. National rates were calculated by diagnosis group. Risk-adjusted hospital-specific rates of adverse event free admissions were calculated using colorectal procedures as an example.
RESULTS
There were 23,991,193 admissions after exclusions. Approximately, 64% went through the acute inpatient Medicare system without record of anything untoward. Multiple events were recorded in 22·7% admissions; 15% of these experienced more than 2 adverse events. Risk-adjusted hospital-specific rates of adverse event free admissions for colorectal procedures showed 131 out of 3786 hospitals below the 99·8% lower control limit of the national upper quartile.
CONCLUSIONS
Overall, only 60% of admissions were recorded as adverse event free. Multiple adverse events were common. Even if events are under recorded, this measure could provide an easily understandable and useful baseline for clinicians and managers.
Topics: Aged; Aged, 80 and over; Colorectal Surgery; Cross-Sectional Studies; Databases, Factual; Female; Humans; Inpatients; Male; Medicare; Outcome Assessment, Health Care; Patient Admission; Patient Readmission; Postoperative Complications; Quality Indicators, Health Care; Retrospective Studies; Risk Assessment; United Kingdom; United States
PubMed: 27192350
DOI: 10.1097/SLA.0000000000001792 -
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 -
MedRxiv : the Preprint Server For... Nov 2023Social stress experienced in childhood is associated with adverse health later in life. Mitochondrial function has been implicated as a mechanism for how stressful life...
Social stress experienced in childhood is associated with adverse health later in life. Mitochondrial function has been implicated as a mechanism for how stressful life events "get under the skin" to influence physical wellbeing. Using data from the Study of Muscle, Mobility and Aging (n=879, 59% women), linear models examined whether adverse childhood events (i.e., physical abuse) were associated with two measures of skeletal muscle mitochondrial energetics in older adults: (1) maximal adenosine triphosphate production (ATP ) and (2) maximal state 3 respiration (Max OXPHOS). Forty-five percent of the sample reported experiencing 1+ adverse childhood event. After adjustment, each additional event was associated with -0.07 SD (95% CI= - 0.12, -0.01) lower ATP . No association was observed with Max OXPHOS. Adverse childhood events are associated with lower ATP production in later life. Findings indicate that mitochondrial function may be a mechanism in understanding how early social stress influences health in later life.
PubMed: 37986889
DOI: 10.1101/2023.11.07.23298177 -
Cureus Sep 2022Cyclosporine is widely used to prevent allograft rejection after transplantation. The purpose of this study was to clarify the adverse events profiles associated with...
BACKGROUND
Cyclosporine is widely used to prevent allograft rejection after transplantation. The purpose of this study was to clarify the adverse events profiles associated with cyclosporine in transplant patients using a spontaneous reporting system database.
METHODS
Retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report (JADER) database, with the reporting odds ratio (ROR) and 95% confidence interval (CI) for each adverse event.
RESULTS
The database comprised 3,327, 958, and 956 reports associated with cyclosporine in the kidney, stem cell, and heart transplant patients, respectively. Infectious and renal disorders were commonly detected in these transplant patients. The signal scores of cyclosporine for toxic nephropathy were noteworthy in the kidney (ROR: 15.1, 95% CI: 11-20.8) and stem cell (ROR, 216; 95% CI, 29.3-1593) transplantation. Cyclosporine in heart transplantation was strongly associated with gastric cancer (ROR, 39.4; 95% CI, 16.7-93.2), but not kidney or stem cell transplantation.
CONCLUSION
It was suggested that there is a diversity in the strength of the association between cyclosporine and adverse events in the kidney, stem cell, and heart transplantation. Our results may provide useful information for treatment with cyclosporine, although further research with more data is needed.
PubMed: 36159360
DOI: 10.7759/cureus.29383 -
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 -
Journal of Radiological Protection :... Dec 2021The potential for unintended and adverse radiation exposure in radiotherapy (RT) is real and should be studied because RT is a highly complex, multistep process, which...
BACKGROUND AND PURPOSE
The potential for unintended and adverse radiation exposure in radiotherapy (RT) is real and should be studied because RT is a highly complex, multistep process, which requires input from numerous individuals from different areas and steps of the RT workflow. The 'Incident' (I) is an event the consequence of which is not negligible from the point of view of protection or safety. A 'near miss' (NM) is defined as an event that is highly likely to happen but did not occur. The purpose of this work is to show that through systematic reporting and analysis of these adverse events, their occurrence can be reduced.
MATERIALS AND METHODS
Staff were trained to report every type of unintended and adverse radiation exposure and to provide a full description of it.
RESULTS
By 2018, 110 worksheets had been collected, with an average of 6.1 adverse events per year (with 780 patients treated per year, meaning an average incident rate of 0.78%). In 2001-2009, 37 events were registered (13 I and 24 NM), the majority of them were in the decision phase (12/37), while in 2010-2013, there were 42 (1 I and 41 NM) in both the dose-calculation and transfer phase (19/42). In 2014-2018, 31 events (1 I and 30 NM) were equally distributed across the phases of the RT process. In 9/15 cases of I, some checkpoint was introduced.
CONCLUSION
The complexity of the RT workflow is prone to errors, and this must be taken into account by encouraging a safety culture. The aim of this paper is to present the collected incidents and near misses and to show how organization and practice were modified by the acquired knowledge.
Topics: Humans; Medical Errors; Patient Safety; Radiation Oncology; Radiotherapy; Risk Management; Safety Management; Workflow
PubMed: 34134092
DOI: 10.1088/1361-6498/ac0c01 -
Frontiers in Oncology 2023PARP inhibitors (PARPis) are novel molecular targeted therapeutics for inhibition of DNA repair in tumor cells, which are commonly used in ovarian cancer. Recent case...
BACKGROUND
PARP inhibitors (PARPis) are novel molecular targeted therapeutics for inhibition of DNA repair in tumor cells, which are commonly used in ovarian cancer. Recent case reports have indicated that haemorrhages-related adverse events may be associated with PARPis. However, little is known about the characteristics and signal strength factors of this kind of adverse event.
METHODS
A pharmacovigilance study from January 2004 to March 2022 based on the FDA adverse event reporting system (FAERS) database was conducted by adopting the proportional imbalance method based on the four algorithms, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural networks (BCPNN) and multi-item gamma Poisson shrinker (MGPS).
RESULTS
725 cases of PARPi-haemorrhages-related adverse events were identified with a fatality rate of 4.72% (30/725) and a median age of 67 years. About 88% of the adverse events occurred within 6 months, and the median duration (IQR) was 68 days. Most adverse events (n=477, 75.11%) were related to the treatment of niraparib. Importantly, niraparib exposure was associated with a significant increase in haemorrhages-related adverse events (ROR (95% CI), 1.13(1.03,1.23), PRR (χ2), 1.12(7.32), IC (IC 025), 0.17(0.15). In addition, petechiae, gingival bleeding, bloody urine, as well as rectal haemorrhage should be monitored when using niraparib.
CONCLUSION
Recognition and management of PARPi-haemorrhages-related adverse events is of significance to clinical practice. In this study, we provided a safety signal that haemorrhage-related adverse events should be monitored for when using niraparib. However, larger and more robust post-market safety studies are needed to improve the quality of this evidence.
PubMed: 36923428
DOI: 10.3389/fonc.2023.1070343