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Mayo Clinic Proceedings Aug 2020To examine differences in the frequency and severity of federally reported adverse events between caffeine-containing and non-caffeine-containing products while also...
OBJECTIVE
To examine differences in the frequency and severity of federally reported adverse events between caffeine-containing and non-caffeine-containing products while also identifying the category of caffeine-containing products associated with the highest frequency and severity of adverse events.
PATIENTS AND METHODS
All adverse event reports that met specified eligibility criteria and were submitted to the Center for Food Safety and Applied Nutrition Adverse Event Reporting System between January 1, 2014, and June 29, 2018, were extracted. In this retrospective observational study, the most severe adverse event experienced, an ordinal variable, was categorized into death, life-threatening, hospitalization/disability, and emergency department visit. A nonproportional odds model was used to compare the odds of caffeine-containing products being associated with more severe adverse events relative to a noncaffeine group. The analysis is of data only from those reporting adverse events and may or may not be representative of the entire population exposed to these products, which is not known from the examined data.
RESULTS
Energy and preworkout products saw a significant increase in the odds of the adverse event experienced being death rather than the other less severe outcomes relative to the noncaffeinated group. Those products, along with weight loss products, had greater odds of the adverse event being death or life-threatening vs the less severe outcomes relative to the noncaffeinated group.
CONCLUSION
Caffeine-containing products have a greater association with severe adverse events compared with non-caffeine-containing products. Exposure to preworkout and weight loss products had greater odds of being associated with a more serious adverse event relative to noncaffeinated products. Health care practitioners should use these outcomes to better inform and educate patients about the many factors related to caffeine intake and adverse outcomes.
Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Aged; Aged, 80 and over; Anti-Obesity Agents; Caffeine; Carbonated Beverages; Child; Child, Preschool; Coffee; Dietary Supplements; Female; Humans; Infant; Male; Middle Aged; Tea; United States; United States Food and Drug Administration; Young Adult
PubMed: 32753134
DOI: 10.1016/j.mayocp.2020.02.033 -
Revista Medica Del Instituto Mexicano... 2016Patient safety is a priority issue in health systems, due to the damage costs, institutional weakening, lack of credibility, and frustration on those who committed an...
BACKGROUND
Patient safety is a priority issue in health systems, due to the damage costs, institutional weakening, lack of credibility, and frustration on those who committed an error that resulted in an adverse event. There is no standardized instrument for recording, reporting, and analyzing sentinel or adverse events (AE) in primary care. Our aim was to design and validate a surveillance system for recording sentinel events, adverse events and near miss incidents in primary care.
METHODS
We made a review of systems for recording and reporting adverse events in primary care. Then, we proposed an instrument to record these events, and register faults in the structure and process, in primary health care units in the Instituto Mexicano del Seguro Social.
RESULTS
We showed VENCER-MF format to 35 subjects. Out of them, 100% identified a failure in care process, 90% recorded a sentinel event, 85% identified the cause of this event, 75% of them suggested some measures for avoiding the recurrence of adverse events. We used a Cronbach's alpha of 0.6, p=0.03.
CONCLUSIONS
The instrument VENCER-MF has a good consistency for the identification of adverse events.
Topics: Adult; Female; Humans; Male; Medical Errors; Mexico; Patient Safety; Primary Health Care; Risk Management
PubMed: 27100978
DOI: No ID Found -
Revista de La Facultad de Ciencias... 2013Patient safety in critical areas has been subject of several studies. In Colombia, there is a growing conscience about adverse events management. This study explores the...
INTRODUCTION
Patient safety in critical areas has been subject of several studies. In Colombia, there is a growing conscience about adverse events management. This study explores the first phase of this management: report in a typical private intensive care unit.
OBJECTIVE
To assess adverse event report at a Colombian tertiary level institution, through frequency and report category assessment.
METHODS
A descriptive study regarding adverse event report rates during 2011 period in Clinica de los Andes de Tunja, was carried out, through frequency and report category assessment. Adverse event report rate was defined as the number of reports per 1000 patient bed. We reported major and minor categories of events.
RESULTS
A total of 383 admissions (2374 patient days) were recorded. 54 adverse events were reported (rate of 22,74 per 1000 patient days). The most frequent events were related to intravenous route (55%)(CI 95% 50,1-58,3) followed by process deviation (22%)(CI 95% 18,2-26,1).
CONCLUSIONS
An adverse event report rate close to the upper limit of literature reports numbers was found. Probably, there is still non quantified under-report of adverse events, likely due to cultural factors.
Topics: Adverse Drug Reaction Reporting Systems; Aged; Aged, 80 and over; Colombia; Critical Care; Female; Humans; Intensive Care Units; Male; Medical Errors; Middle Aged
PubMed: 24067590
DOI: No ID Found -
Child's Nervous System : ChNS :... Mar 2017The purpose of this study is to record the 30-day and inpatient morbidity and mortality in paediatric patients in a tertiary neuroscience centre over a 2-year period.... (Review)
Review
PURPOSE
The purpose of this study is to record the 30-day and inpatient morbidity and mortality in paediatric patients in a tertiary neuroscience centre over a 2-year period. The intentions were to establish the frequency of significant adverse events, review the current published rates of morbidity in paediatric neurosurgical patients and propose three clinical indicators for future comparison.
METHODS
All deaths and adverse events were prospectively recorded from 1 January 2014 to 31 December 2015. Each adverse event was categorised, allocated a clinical impact severity score and linked to a neurosurgical procedure wherever possible. Where a patient suffered several adverse events in the same admission, each event was recorded separately. If a patient had been discharged home, an adverse event was recorded if it occurred within 30 days of admission.
RESULTS
Five hundred forty-nine procedures were performed in 287 patients (aged <16 years). One hundred thirty significant adverse events were identified. The following are the three clinical indicators: significant adverse event rate: 111 (20.2%) operations were linked to at least one significant adverse event; unscheduled return to theatre rate: 81 (14.8%) operations were associated with an adverse event that resulted in an unscheduled return to theatre; and surgical site infection rate: 29 (5.3%) operations were associated with an infection.
CONCLUSION
Complications and adverse events are common in paediatric neurosurgery. Prospective, continuous surveillance will promote both quality assurance and quality improvement in the neurosurgical care delivered to patients.
Topics: Adolescent; Child; Child, Preschool; Female; Humans; Male; Neurosurgical Procedures; Pediatrics; Postoperative Complications; Prospective Studies; Risk Factors
PubMed: 28247111
DOI: 10.1007/s00381-017-3358-5 -
JMIR Medical Informatics Sep 2022Adverse reactions to drugs attract significant concern in both clinical practice and public health monitoring. Multiple measures have been put into place to increase...
BACKGROUND
Adverse reactions to drugs attract significant concern in both clinical practice and public health monitoring. Multiple measures have been put into place to increase postmarketing surveillance of the adverse effects of drugs and to improve drug safety. These measures include implementing spontaneous reporting systems and developing automated natural language processing systems based on data from electronic health records and social media to collect evidence of adverse drug events that can be further investigated as possible adverse reactions.
OBJECTIVE
While using social media for collecting evidence of adverse drug events has potential, it is not clear whether social media are a reliable source for this information. Our work aims to (1) develop natural language processing approaches to identify adverse drug events on social media and (2) assess the reliability of social media data to identify adverse drug events.
METHODS
We propose a collocated long short-term memory network model with attentive pooling and aggregated, contextual representation generated by a pretrained model. We applied this model on large-scale Twitter data to identify adverse drug event-related tweets. We conducted a qualitative content analysis of these tweets to validate the reliability of social media data as a means to collect such information.
RESULTS
The model outperformed a variant without contextual representation during both the validation and evaluation phases. Through the content analysis of adverse drug event tweets, we observed that adverse drug event-related discussions had 7 themes. Mental health-related, sleep-related, and pain-related adverse drug event discussions were most frequent. We also contrast known adverse drug reactions to those mentioned in tweets.
CONCLUSIONS
We observed a distinct improvement in the model when it used contextual information. However, our results reveal weak generalizability of the current systems to unseen data. Additional research is needed to fully utilize social media data and improve the robustness and reliability of natural language processing systems. The content analysis, on the other hand, showed that Twitter covered a sufficiently wide range of adverse drug events, as well as known adverse reactions, for the drugs mentioned in tweets. Our work demonstrates that social media can be a reliable data source for collecting adverse drug event mentions.
PubMed: 36170004
DOI: 10.2196/38140 -
Aesthetic Surgery Journal. Open Forum 2022Protein denaturation and collagen contraction occur when living tissue is heated to well-defined temperatures. The result is reduced volume and surface area of the...
BACKGROUND
Protein denaturation and collagen contraction occur when living tissue is heated to well-defined temperatures. The result is reduced volume and surface area of the heated tissue.
OBJECTIVES
To evaluate the adverse events of procedures in which a helium-based plasma technology (HPT) was used with and without ultrasound-assisted liposuction for the coagulation of soft tissue.
METHODS
A multicenter retrospective chart review was performed in which patients (n = 192) were divided into 2 groups: one that received only soft tissue coagulation and the other that received both soft tissue coagulation and liposuction. Each of the 2 groups was subdivided into patients with and without adverse events, including seroma. Odds ratios for adverse events were calculated for both demographic and surgical subgroups. Seroma data were analyzed separately.
RESULTS
No serious adverse events were observed. Forty-six (24.0%) patients reported 51 total adverse events. Seroma was the most frequently occurring adverse event with 13 patients (6.8%) reporting 17 (33.3%) events in 12 body areas. In these cases, all areas were treated with both liposuction and soft tissue coagulation. Seroma was not observed in patients receiving soft tissue coagulation alone. Patients aged 61 to 76 years and males were more likely to experience seroma or other adverse event than younger patients or females, respectively.
CONCLUSIONS
The use of the HPT for soft tissue coagulation in combination with ultrasound for liposuction is associated with nonserious adverse events. The most frequently occurring adverse event, seroma, was not observed in patients treated with HPT alone.
PubMed: 36211477
DOI: 10.1093/asjof/ojac064 -
Joint Commission Journal on Quality and... Dec 2018Anesthesiologists have studied adverse events during anesthesia dating back to the original critical incident studies of the 1970s. Despite improvements, adverse events...
BACKGROUND
Anesthesiologists have studied adverse events during anesthesia dating back to the original critical incident studies of the 1970s. Despite improvements, adverse events continue to occur. The purpose of this study was to characterize anesthesia-related adverse events within a single large tertiary care institution and to distinguish preventable adverse events from those that are not preventable.
METHODS
A retrospective review of all cases referred to the Performance Improvement (PI) Committee at a large academic medical center from 2007 to 2015 was performed. The primary adverse event and underlying cause of the event were determined using a two-reviewer system for each case. Univariate analysis was performed to determine overall characteristics of cases, the underlying causes of adverse events, and whether the event was preventable; p < 0.05 was considered significant.
RESULTS
A total of 1,424 records were referred to the PI Committee during the study period. After exclusions, 747 cases were included in the final analysis. Respiratory complications (n = 245) were the most frequently reported adverse event type. The most common respiratory events included unplanned reintubations, aspirations, and respiratory arrests. A large proportion of the adverse events (42.8%) may have been preventable. In particular, respiratory, trauma, and medication adverse events were often preventable.
CONCLUSION
Anesthesia-related adverse events continue to occur even though the field is considered at the forefront of patient safety. Respiratory, trauma, and medication events were often preventable, and these represent areas to allocate resources to improve patient safety and perioperative outcomes.
Topics: Academic Medical Centers; Adult; Aged; Aged, 80 and over; Anesthesia; Basic Helix-Loop-Helix Transcription Factors; Comorbidity; Female; Humans; Male; Middle Aged; Patient Safety; Postoperative Complications; Quality Improvement; Retrospective Studies; Socioeconomic Factors; Tertiary Care Centers
PubMed: 30064954
DOI: 10.1016/j.jcjq.2018.03.013 -
Frontiers in Pharmacology 2022Adverse drug events (ADEs) in the elderly frequently occur because of their multiple chronic diseases and complexity of drug therapy. To better understand adverse drug...
Adverse drug events (ADEs) in the elderly frequently occur because of their multiple chronic diseases and complexity of drug therapy. To better understand adverse drug events, the prevalence and characteristics of adverse drug events in elderly South Korean patients were assessed. The National Health Insurance databases for 2015 and 2016 were used for the analysis. We included patients aged ≥65 years that had at least one claim with the diagnosis codes 'drug-induced,' 'poisoning by drug,' and 'vaccine-associated' each year for the base-case analysis. To minimize the underestimation of adverse drug event prevalence, we also used an extended definition analysis by adding the 'adverse drug event very likely' codes. We estimated the prevalence of adverse drug events by sex, age group, and type of insurance and examined the frequent types of adverse drug events in 2015 and 2016. In the base-case analysis, adverse drug event prevalence in individuals aged 65 years and older was 2.75% in 2015 and 2.77% in 2016. With advanced age, the prevalence of adverse drug event tended to increase, peaking in the age group of 75-79 years. In addition, the adverse drug event prevalence was higher in females and Medical Aid enrollees. The most frequently occurring adverse drug event was 'allergy, unspecified,' followed by 'other drug-induced secondary parkinsonism,' and 'generalized skin eruption due to drugs and medicaments.' When we examined the extended definition analysis, the prevalence of adverse drug events was 4.47% in 2015 and 4.52% in 2016, which significantly increased from those estimated in the base-case analysis. Among the older adults, the prevalence of adverse drug event was higher in advanced age, females, and Medical Aid enrollees. In particular, allergy and drug-induced secondary parkinsonism frequently occurred. This study provides evidence that health policies addressing the prevention and management of adverse drug events should be a priority for the most vulnerable elderly patients.
PubMed: 36532737
DOI: 10.3389/fphar.2022.1047387 -
Frontiers in Public Health 2024Social media platforms serve as a valuable resource for users to share health-related information, aiding in the monitoring of adverse events linked to medications and...
INTRODUCTION
Social media platforms serve as a valuable resource for users to share health-related information, aiding in the monitoring of adverse events linked to medications and treatments in drug safety surveillance. However, extracting drug-related adverse events accurately and efficiently from social media poses challenges in both natural language processing research and the pharmacovigilance domain.
METHOD
Recognizing the lack of detailed implementation and evaluation of Bidirectional Encoder Representations from Transformers (BERT)-based models for drug adverse event extraction on social media, we developed a BERT-based language model tailored to identifying drug adverse events in this context. Our model utilized publicly available labeled adverse event data from the ADE-Corpus-V2. Constructing the BERT-based model involved optimizing key hyperparameters, such as the number of training epochs, batch size, and learning rate. Through ten hold-out evaluations on ADE-Corpus-V2 data and external social media datasets, our model consistently demonstrated high accuracy in drug adverse event detection.
RESULT
The hold-out evaluations resulted in average F1 scores of 0.8575, 0.9049, and 0.9813 for detecting words of adverse events, words in adverse events, and words not in adverse events, respectively. External validation using human-labeled adverse event tweets data from SMM4H further substantiated the effectiveness of our model, yielding F1 scores 0.8127, 0.8068, and 0.9790 for detecting words of adverse events, words in adverse events, and words not in adverse events, respectively.
DISCUSSION
This study not only showcases the effectiveness of BERT-based language models in accurately identifying drug-related adverse events in the dynamic landscape of social media data, but also addresses the need for the implementation of a comprehensive study design and evaluation. By doing so, we contribute to the advancement of pharmacovigilance practices and methodologies in the context of emerging information sources like social media.
Topics: Social Media; Pharmacovigilance; Humans; Natural Language Processing; Drug-Related Side Effects and Adverse Reactions; Adverse Drug Reaction Reporting Systems
PubMed: 38716250
DOI: 10.3389/fpubh.2024.1392180