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OTO Open 2023Eustachian tube balloon dilation is a minimally invasive technique used to improve persistent Eustachian tube dysfunction. Currently, the US Food and Drug Administration...
OBJECTIVE
Eustachian tube balloon dilation is a minimally invasive technique used to improve persistent Eustachian tube dysfunction. Currently, the US Food and Drug Administration (FDA) has approved the use of balloon dilation devices produced by three manufacturers, but little is known about associated adverse events and subsequent management.
STUDY DESIGN
Case series.
SETTING
FDA Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS
Reports submitted to the FDA using the MAUDE database searched from January 2000 to July 2022 were analyzed for adverse events and management.
RESULTS
A total of 13 adverse events were found in the database. Subcutaneous emphysema (n = 8) was the most common event. Other less frequent events included patulous Eustachian tube (n = 2), vascular dissection (n = 1), nasopharyngeal mucocele (n = 1), and tinnitus (n = 1). A majority of patients who experienced subcutaneous emphysema received antibiotics (n = 5) and were admitted to the hospital (n = 4). The patient with a carotid dissection 7 days postprocedure presented with a stroke and fully recovered after stent placement. There was limited preprocedure information in the MAUDE database. There were 2 patients who did not fully recover after a complication. Three patients underwent corrective surgical interventions. No one company had more associated adverse events reported.
CONCLUSION
Subcutaneous emphysema is the most common adverse event after Eustachian tube dilation. Further studies exploring potential balloon dilation adverse events to allow for better patient counseling are warranted.
PubMed: 37565059
DOI: 10.1002/oto2.70 -
Health Informatics Journal Sep 2019This study sought to determine how the proportion of physicians using electronic prescribing in nine US states was associated with the hospitalization rate for adverse...
This study sought to determine how the proportion of physicians using electronic prescribing in nine US states was associated with the hospitalization rate for adverse drug events among older adult patients. A discharge-level analysis of the relationship between county electronic prescribing and adverse drug event hospitalization rates was conducted. Data from the 2011 State Inpatient Databases, the Office of the National Coordinator Health IT Dashboard, and the Area Health Resource File were obtained for nine US states. The analysis examined the odds that a discharge for older adults would have been adverse drug event associated, versus other causes, using multivariable logistic regression models. After adjusting for patient, provider, health infrastructure, and community factors, the lowest county electronic prescribing rate quartile was associated with significantly greater odds of an adverse drug event hospitalization (odds ratio: 1.10; 95% confidence interval: 1.02-1.19). Early results indicate greater odds of adverse drug event hospitalizations among older adults living in counties with low electronic prescribing rates when compared to those in high electronic prescribing counties.
Topics: Aged; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Electronic Prescribing; Female; Hospitalization; Humans; Male; Medical Informatics; Patient Discharge; United States
PubMed: 28737062
DOI: 10.1177/1460458217720396 -
Frontiers in Pediatrics 2020Non-anesthesiologist-administered propofol (NAAP) has been found to have an acceptable safety profile in adult endoscopy, but its use remains controversial and...
Non-anesthesiologist-administered propofol (NAAP) has been found to have an acceptable safety profile in adult endoscopy, but its use remains controversial and pediatric data is limited. Our aim was to examine the safety and efficacy of NAAP provided by pediatric hospitalists in pediatric endoscopy. We retrospectively reviewed 929 esophagogastroduodenoscopy (EGD), colonoscopy, and combined EGD/colonoscopy cases in children aged 5-20 years between April 2015 and December 2016 at a large children's hospital. We analyzed the data for adverse events in relation to demographics and anthropometrics, American Society of Anesthesiologists physical classification score, presence of a trainee, comorbid conditions, and procedure time. A total of 929 cases were included of which 496 (53%) were completed with NAAP. Seventeen (3.4%) of NAAP cases had an adverse event including the following: 12 cases of hypoxia, 2 cardiac, and 3 gastrointestinal adverse events. General anesthesia cases had 62 (14.3%) adverse events including the following: 54 cases of hypoxia, 1 cardiac, 7 gastrointestinal, and 1 urologic adverse event. No adverse events in either group required major resuscitation. NAAP vs. general anesthesia had a lower overall adverse event rate (3.4 vs. 14.3%, < 0.0004) and respiratory adverse event rate (2.4% vs. 12.5%, < 0.0004). Overall, cardiac and gastrointestinal adverse event rates between the two groups were comparable. When accounting for all captured factors via logistic regression, both younger age ( < 0.001) and general anesthesia ( < 0.0001) remained risk factors for an adverse event. The overall adverse event rate of NAAP was low (3.4%) with none requiring major resuscitation or hospitalization. This is comparable to studies of NAAP in adult endoscopy and suggests that NAAP provided by pediatric hospitalists has an acceptable safety profile.
PubMed: 33604318
DOI: 10.3389/fped.2020.619139 -
The Journal of Cardiovascular NursingHeart failure (HF) is associated with chronic inflammation, which is adversely associated with survival. Although sex-related differences in inflammation have been...
BACKGROUND
Heart failure (HF) is associated with chronic inflammation, which is adversely associated with survival. Although sex-related differences in inflammation have been described in patients with HF, whether sex-related differences in inflammation are associated with event-free survival has not been examined.
AIM
The aim of this study was to determine whether the association between inflammation as indicated by tumor necrosis factor-α and event-free survival differs between men and women with HF after controlling for demographic and clinical variables.
METHOD
This was a secondary analysis of data from 301 male (age, 61.0 ± 11.4 years) and 137 female (age, 60.3 ± 12.1 years) patients with HF. Serum levels of soluble tumor necrosis factor receptor 1 were used to indicate inflammatory status. Patients were grouped according to median split of soluble tumor necrosis factor receptor 1 level and sex into male with low inflammation (≤1820 pg/mL) (n = 158) or high inflammation (>1820 pg/mL) (n = 143), and female with low inflammation (n = 63) or high inflammation (n = 74). Cox regression models were run separately for men and women to determine whether inflammation contributed to differences in event-free survival between sexes with HF.
RESULTS
There were 84 male (27.9%) and 27 female (19.7%) patients who had an event. Event-free survival in women did not differ by the severity of inflammation in the Cox regression analysis. In contrast, men with high inflammation had 1.85 times higher risk for an event compared with men with low inflammation.
CONCLUSION
These data provide evidence that inflammation contributed to differences in event-free survival in men but not women with HF. Clinicians should be aware that men who have higher inflammation may be at a greater risk of HF or cardiac-related events than others with HF.
Topics: Humans; Male; Female; Middle Aged; Aged; Progression-Free Survival; Sex Characteristics; Disease-Free Survival; Prospective Studies; Inflammation; Heart Failure
PubMed: 37707972
DOI: 10.1097/JCN.0000000000000831 -
Cureus Jun 2023Patients with olmesartan-induced enteropathy, a rare illness, frequently endure prolonged diarrhea and weight loss with no apparent cause. Because this adverse event's...
Patients with olmesartan-induced enteropathy, a rare illness, frequently endure prolonged diarrhea and weight loss with no apparent cause. Because this adverse event's clinical and histological characteristics mimic those of other small intestine illnesses, it can be challenging to recognize it in a timely manner. We report a case of olmesartan-induced enteropathy in a 58-year-old male who had been on olmesartan for several years. Recently, during his travel to Greece, he developed diarrhea lasting several weeks. This was accompanied by a significant weight loss of 35 lbs, acute kidney injury, and hypokalemia. Extensive negative workup, including esophagogastroduodenoscopy (EGD) with normal biopsy of esophagus, stomach, duodenum, and terminal ileum, and colonoscopy with biopsies, autoimmune serologies, and infectious disease workup, led to a diagnosis of olmesartan-induced enteropathy as a diagnosis of exclusion. Diarrhea improved/resolved within a few days after stopping olmesartan in our patient.
PubMed: 37456382
DOI: 10.7759/cureus.40342 -
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 -
BMJ Quality & Safety Oct 2022Despite the high number of children treated in emergency departments, patient safety risks in this setting are not well quantified. Our objective was to estimate the...
BACKGROUND
Despite the high number of children treated in emergency departments, patient safety risks in this setting are not well quantified. Our objective was to estimate the risk and type of adverse events, as well as their preventability and severity, for children treated in a paediatric emergency department.
METHODS
Our prospective, multicentre cohort study enrolled children presenting for care during one of 168 8-hour study shifts across nine paediatric emergency departments. Our primary outcome was an adverse event within 21 days of enrolment which was related to care provided at the enrolment visit. We identified 'flagged outcomes' (such as hospital visits, worsening symptoms) through structured telephone interviews with patients and families over the 21 days following enrolment. We screened admitted patients' health records with a validated trigger tool. For patients with flags or triggers, three reviewers independently determined whether an adverse event occurred.
RESULTS
We enrolled 6376 children; 6015 (94%) had follow-up data. Enrolled children had a median age of 4.3 years (IQR 1.6-9.8 years). One hundred and seventy-nine children (3.0%, 95% CI 2.6% to 3.5%) had at least one adverse event. There were 187 adverse events in total; 143 (76.5%, 95% CI 68.9% to 82.7%) were deemed preventable. Management (n=98, 52.4%) and diagnostic issues (n=36, 19.3%) were the most common types of adverse events. Seventy-nine (42.2%) events resulted in a return emergency department visit; 24 (12.8%) resulted in hospital admission; and 3 (1.6%) resulted in transfer to a critical care unit.
CONCLUSION
In this large-scale study, 1 in 33 children treated in a paediatric emergency department experienced an adverse event related to the care they received there. The majority of events were preventable; most were related to management and diagnostic issues. Specific patient populations were at higher risk of adverse events. We identify opportunities for improvement in care.
Topics: Child; Humans; Infant; Child, Preschool; Prospective Studies; Cohort Studies; Hospitalization; Patient Safety; Emergency Service, Hospital
PubMed: 35853646
DOI: 10.1136/bmjqs-2021-014608