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The American Journal of Managed Care Jun 2023To compare the frequency of self-reported gaps in care coordination and self-reported preventable adverse events among adults with vs without diabetes.
OBJECTIVES
To compare the frequency of self-reported gaps in care coordination and self-reported preventable adverse events among adults with vs without diabetes.
STUDY DESIGN
Cross-sectional analysis of REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants 65 years and older who completed a survey on health care experiences in 2017-2018 (N = 5634).
METHODS
We analyzed the association of diabetes with self-reported gaps in care coordination and with preventable adverse events. Gaps in care coordination were assessed using 8 validated questions. Four self-reported adverse events were studied (drug-drug interactions, repeat medical tests, emergency department visits, and hospitalizations). Respondents were asked if they thought these events could have been prevented with better communication among providers.
RESULTS
Overall, 1724 (30.6%) participants had diabetes. Among participants with and without diabetes, 39.3% and 40.7%, respectively, reported any gap in care coordination. The adjusted prevalence ratio (aPR) for any gap in care coordination for participants with vs without diabetes was 0.97 (95% CI, 0.89-1.06). Any preventable adverse event was reported by 12.9% and 8.7% of participants with and without diabetes, respectively. The aPR for any preventable adverse event for participants with vs without diabetes was 1.22 (95% CI, 1.00-1.49). Among participants with and without diabetes, the aPRs for any preventable adverse event associated with any gap in care coordination were 1.53 (95% CI, 1.15-2.04) and 1.50 (95% CI, 1.21-1.88), respectively (P comparing aPRs = .922).
CONCLUSIONS
Interventions to improve quality of care for patients with diabetes could incorporate patient-reported gaps in care coordination to aid in preventing adverse events.
Topics: Adult; Humans; Cross-Sectional Studies; Diabetes Mellitus; Hospitalization; Emergency Service, Hospital; Communication
PubMed: 37341980
DOI: 10.37765/ajmc.2023.89374 -
International Journal of Sports... Feb 2020There is a paucity of literature about the adverse events associated with Therapeutic Dry Needling (TDN). Much of the literature surrounding adverse events associated...
BACKGROUND
There is a paucity of literature about the adverse events associated with Therapeutic Dry Needling (TDN). Much of the literature surrounding adverse events associated with TDN has been extrapolated from the acupuncture literature. Given that acupuncture and TDN are distinctly different in their application and proposed mechanisms, adverse events associated with TDN should be examined specifically.
PURPOSE
To determine and report the type of adverse events associated with the utilization of TDN.
STUDY DESIGN
Prospective Questionnaire.
METHODS
Four hundred and twenty physical therapists participated in this study. Information related to minor and major adverse events that occurred during 20,464 TDN treatment sessions was collected. Each physical therapist respondent was asked to fill out two weekly self-reported electronic surveys over a six-week period. One survey was related to "minor adverse events" (i.e. pain, bleeding, bruising), while the other was related to "major adverse events" (i.e. pneumothorax, excessive bleeding, prolonged aggravation). Following the six-week period, descriptive statistics were used to describe the adverse events (AE) associated with TDN and calculate the frequencies of those events.
RESULTS
A total of 7,531 minor AE's were reported, indicating that 36.7% of the reported TDN treatments resulted in a minor AE. The top three minor AE's were bleeding (16%), bruising (7.7%), and pain during dry needling (5.9 %). The average ratio of minor AE's for all respondents across all weeks was 0.53 or approximately one event for every two patients. Twenty major AE's were reported out of the 20,494 treatments for a rate of <0.1% (1 per 1,024 TDN treatments). No associations were noted between the frequency of adverse events and the number of patients treated, practitioner age, level of education, years in practice, level of training or months experience with dry needling.
CONCLUSION
Expected minor AE's such as mild bleeding, bruising, and pain during TDN were common and major AE's were rare. Physical therapists and other medical practitioners need to be aware of the risks of TDN. Based on the findings of this study the overall risk of a major adverse event during TDN is small.
LEVEL OF EVIDENCE
3, survey research.
PubMed: 32089962
DOI: No ID Found -
Journal of Cannabis Research May 2023There is an expanding unregulated market for a psychotropic compound called ∆-Tetrahydrocannabinol (delta-8-THC) that is being derived from hemp, but a summary of...
BACKGROUND
There is an expanding unregulated market for a psychotropic compound called ∆-Tetrahydrocannabinol (delta-8-THC) that is being derived from hemp, but a summary of adverse events related to delta-8-THC has not been publicly reported.
METHODS
This case series assessed adverse events reported by delta-8-THC users on the Reddit forum r/Delta8 and compared these to delta-8-THC AEs in the US Food and Drug Administration Adverse Event Reporting System (FAERS). Delta-8-THC and cannabis AEs reported in FAERS were also compared. The r/Delta8 forum was selected because it includes a large sample of 98,700 registered individuals who publicly discuss their experiences using delta-8-THC. All r/Delta8 posts were obtained from August 20, 2020, through September 25, 2022. A random sample of r/Delta8 posts was drawn (n = 10,000) and filtered for posts in which delta-8-THC users reported an adverse event (n = 335). FAERS reports that listed delta-8-THC (N = 326) or cannabis (N = 7076) as a suspect product active ingredient were obtained. Adverse events claimed to result from delta-8-THC use were coded using Medical Dictionary for Regulatory Activities to system organ class and preferred term categories.
RESULTS
The absolute number of delta-8-THC adverse event reports (N = 2184, 95% CI = 1949-2426) and serious adverse event reports (N = 437; 95% CI = 339-541) on r/Delta 8 were higher than the adverse event reports (N = 326) and serious adverse event reports (N = 289) to FAERS. Psychiatric disorders were the most frequently cited system organ class in r/Delta8 adverse event reports, mentioned in 41.2% (95% CI = 35.8%-46.3%) of reports, followed by respiratory, thoracic and mediastinal disorders (29.3%, 95% CI = 25.1%-34.0%) and nervous system disorders (23.3%, 95% CI = 18.5%-27.5%). Anxiety (16.4%, 95% CI = 12.8-20.6), Cough (15.5%, 95% CI = 11.9-20.0) and Paranoia (9.3%, 95% CI = 6.3-12.5) were the most frequently cited preferred terms in adverse event reports. The overall prevalence of AEs reported for cannabis and delta-8-THC on FAERS were also similar when analyzed by system organ class (Pearson's r = 0.88).
CONCLUSIONS
The findings of this case series suggest that most of the adverse events reported by delta-8-THC users are like those reported during acute cannabis intoxication. This finding suggests that health care professionals follow similar treatment and management protocols, and that jurisdictions should clarify whether delta-8-THC can be sold as a hemp product.
PubMed: 37217977
DOI: 10.1186/s42238-023-00191-y -
PLOS Global Public Health 2022Safe and effective vaccination remains the mainstay of control of COVID-19 because there is still no universally recommended treatment. This strategy is however being...
Safe and effective vaccination remains the mainstay of control of COVID-19 because there is still no universally recommended treatment. This strategy is however being threatened by vaccine hesitancy and resistance due to fear of adverse events and safety concerns. It is, therefore, necessary to study post-vaccination adverse events (AE) in various populations and geographical areas. The objective of this study was to analyze the adverse events following COVID-19 vaccination in five major immunization centers of Kwara State Nigeria. A retrospective descriptive study of the adverse events following AstraZeneca COVID-19 vaccination that were reported from five immunization centers of Kwara State, North-central Nigeria from March to July 2021 was carried out. Statistical Package for Social Science version 26 was used for analysis. Adverse event classification and severity were compared based on age, gender, and time to onset of adverse event and vaccine dose type using the Chi-square test. The incidence of COVID-19 vaccine AE was 1.6%. There was female predominance (51.6%) and a mean age of 41.6±13.7 years. Most of the AE (95.8%) were systemic and mild (81.1%) without a requirement for any therapeutic intervention. Fatal outcome was not reported in any of the AE and the time to outcome of AE was 2 days in most cases (45.3%). No significant association was found between the variables studied and the adverse event type and severity. The low incidence and mild nature of adverse events reported in this study will add to the body of knowledge regarding vaccine adverse events and may eventually impact vaccine uptake.
PubMed: 36962774
DOI: 10.1371/journal.pgph.0000835 -
Medicine Oct 2020Despite safety concerns associated with topiramate use, the pattern of adverse events and signal analysis of antiepileptic drugs remain elusive.We aimed to determine... (Observational Study)
Observational Study
Despite safety concerns associated with topiramate use, the pattern of adverse events and signal analysis of antiepileptic drugs remain elusive.We aimed to determine patient demographics and characteristics of reported AEs of topiramate and to detect the associated signals by comparing those of other antiepileptics.We used the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) from 2010 to 2017 to determine patient demographics and characteristics of reported AEs for topiramate and other antiepileptics. The proportional reporting ratio, reporting odds ratio, and information component were used in signal detection. Signals were compared against drug labels in Korea, the UK, the EU, and the US.A total of 1300 adverse events cases of topiramate were reported, and the number of topiramate-adverse event pairs was 1861. For topiramate, the proportion of women of childbearing age (20-39 years) with adverse events was more than double that for other antiepileptics. A majority of the 36 detected signals were of neuropsychiatric disorders such as cognitive disorders, concentration impaired, amnesia, hypoaesthesia. Patients with topiramate-induced adverse events were likely to be young and female. Also, adverse events related to carbonic anhydrase isoenzyme showed specifically great disproportionalities.Rigorous clinical management is needed to ensure proper and safe use of topiramate. Special precautions should be taken when prescribing in women of childbearing age.
Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Anticonvulsants; Child; Child, Preschool; Female; Humans; Infant; Male; Middle Aged; Topiramate; Young Adult
PubMed: 33080709
DOI: 10.1097/MD.0000000000022669 -
Cardiovascular Therapeutics 2023Alirocumab and evolocumab, as protein convertase subtilisin kexin type 9 (PCSK9) inhibitors, have been reported to reduce cardiovascular risk. This meta-analysis is... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Alirocumab and evolocumab, as protein convertase subtilisin kexin type 9 (PCSK9) inhibitors, have been reported to reduce cardiovascular risk. This meta-analysis is aimed at updating the safety data of PCSK9 inhibitors.
METHODS
We assessed the relative risk for all treatment-related adverse events, serious adverse events, diabetes-related adverse events, and neurocognitive and neurologic adverse events with PCSK9 inhibitors compared to controls (placebo or ezetimibe). In addition, we conducted a meta-analysis to quantitatively integrate and estimate the adverse event rates in long-term studies.
RESULTS
There were no significant differences between PCSK9 inhibitors and controls in the relative risk analysis. In a subgroup analysis of each PCSK9 inhibitor, alirocumab treatment significantly reduced the risk of serious adverse events compared to control treatment (risk ratio (RR) = 0.937; 95% confidence interval (CI), 0.896-0.980), but no significant difference was observed with evolocumab treatment (RR = 1.003; 95% CI, 0.963-1.054). Moreover, alirocumab treatment afforded a significant reduction in the risk of diabetes-related adverse events compared to control treatment (RR = 0.9137; 95% CI, 0.845-0.987). The overall incidence (event rate) of long-term adverse events was 75.1% (95% CI, 71.2%-78.7%), and the incidence of serious long-term event rate was 16.2% (95% CI, 11.6%-22.3%).
CONCLUSIONS
We suggest that alirocumab and evolocumab are generally safe and well tolerated and that their addition to background lipid-lowering therapy is not associated with an increased risk of adverse events or toxicity.
Topics: Humans; Antibodies, Monoclonal; Anticholesteremic Agents; Cardiovascular Diseases; PCSK9 Inhibitors; Subtilisin
PubMed: 36704607
DOI: 10.1155/2023/7362551 -
World Journal of Hepatology Apr 2015Interactions between the functioning of the heart and the liver have been described, with heart diseases affecting the liver, liver diseases affecting the heart, and... (Review)
Review
Interactions between the functioning of the heart and the liver have been described, with heart diseases affecting the liver, liver diseases affecting the heart, and conditions that simultaneously affect both. The heart is one of the most adversely affected organs in patients with liver cirrhosis. For example, arrhythmias and electrocardiographic changes are observed in patients with liver cirrhosis. The risk for arrhythmia is influenced by factors such as cirrhotic cardiomyopathy, cardiac ion channel remodeling, electrolyte imbalances, impaired autonomic function, hepatorenal syndrome, metabolic abnormalities, advanced age, inflammatory syndrome, stressful events, impaired drug metabolism and comorbidities. Close monitoring of cirrhotic patients is needed for arrhythmias, particularly when QT interval-prolonging drugs are given, or if electrolyte imbalances or hepatorenal syndrome appear. Arrhythmia risk may persist after liver transplantation due to possible QT interval prolongation, persistence of the parasympathetic impairment, post-transplant reperfusion and chronic immunosuppression, as well as consideration of the fact that the transplant itself is a stressful event for the cardiovascular system. The aims of the present article were to provide a review of the most important data regarding the epidemiology, pathophysiology, and biomarkers of arrhythmia risk in patients with liver cirrhosis, to elucidate the association with long-term outcome, and to propose future research directions.
PubMed: 25866603
DOI: 10.4254/wjh.v7.i4.662 -
Aquatic Toxicology (Amsterdam,... May 2020This study was undertaken to systematically assess the utilities and performance of ontology-based semantic analysis in adverse outcome pathway (AOP) research. With an...
This study was undertaken to systematically assess the utilities and performance of ontology-based semantic analysis in adverse outcome pathway (AOP) research. With an increasing number of AOPs developed by scientific domain experts to organize toxicity information and facilitate chemical risk assessment, there is a pressing need for objective approaches to evaluate the biological coherence and quality of these AOPs. Powered by ontologies covering a wide range of biological domains, abundant phenotypic data annotated ontologically, and some sophisticated knowledge computing tools, semantic analysis has great potential in this area of application. With the events in the AOP-Wiki first annotated into logical definitions and then grouped into phenotypic profiles by individual AOPs, the coherence and quality of AOPs were assessed at several levels: paired key event relationships (KER), all possible event pair combinations within AOPs, and the phenotypic profiles of AOPs, genes, biological pathways, human diseases, and selected chemicals. The semantic similarities were assessed at all these levels based on a unified cross-species vertebrate phenotype ontology encompassing the logical definitions of AOP events as well as many other domain ontologies. A substantial number of KERs and AOPs in the AOP-Wiki were found to be semantically coherent. These same coherent AOPs also mapped to many more genes, pathways, and diseases biologically aligned with the intended chain of events therein leading to their respective adverse outcomes. Significantly, these findings imply that semantic analysis should also have utilities in developing future AOPs by selecting candidate events from either the existing AOP-Wiki events or a broader collection of ontology terms semantically similar to the molecular initiating events or adverse outcomes of interest. In addition, semantic analysis enabled AOP networks to be constructed at the level of phenotypic profiles based on similarities, complementing those based on event sharing by bringing genes, pathways, diseases, and chemicals into the networks too-thus greatly expanding the biological scope and our understanding of AOPs.
Topics: Adverse Outcome Pathways; Animals; Biological Ontologies; Biomedical Research; Humans; Phenotype; Risk Assessment; Semantics; Toxicology
PubMed: 32278258
DOI: 10.1016/j.aquatox.2020.105478 -
Pharmaceuticals (Basel, Switzerland) Nov 2023Adverse events associated with opioid use in palliative care have been extensively studied. However, predicting the occurrence of adverse events based on the specific...
Adverse events associated with opioid use in palliative care have been extensively studied. However, predicting the occurrence of adverse events based on the specific opioid used remains difficult. This study aimed to comprehensively analyze the adverse events related to µ-opioid receptor stimulation of opioids approved in Japan and investigate the tendencies of adverse event occurrence among different opioids. We utilized the FDA Adverse Event Reporting System database to extract reported adverse events for opioids approved in Japan. Cluster analysis was performed on reporting odds ratios (RORs) of adverse event names among opioids to visualize relationships between opioids and adverse events, facilitating a comparative study of their classifications. We calculated the RORs of adverse events for the target opioids. Cluster analysis based on these RORs resulted in five broad clusters based on the reported adverse events: i.e., strong opioids, weak opioids, loperamide, tapentadol, and remifentanil. This study provides a comprehensive classification of the association between μ-opioid-receptor-stimulating opioids and adverse events.
PubMed: 38004407
DOI: 10.3390/ph16111541 -
Atherosclerosis Plus Dec 2021The increasing prevalence of diabetes mellitus is causing a massive growth of peripheral artery disease incidences, a disabling complication of diabetic atherosclerosis,... (Review)
Review
BACKGROUND AND AIMS
The increasing prevalence of diabetes mellitus is causing a massive growth of peripheral artery disease incidences, a disabling complication of diabetic atherosclerosis, which leads often to the amputation of the affected limb. Critical limb ischemia is the terminal disease stage, which requires a prompt intervention to relieve pain and save limbs. However, patients undergoing revascularization often suffer from cardiovascular, cerebrovascular and major adverse limb events with poor outcomes. Furthermore, the same procedure performed in apparently similar patients has various outcomes and lack of an outcome predictive support causes a high lower limb arterial revascularization rate with disastrous effects for patients. We collected the main risk factors of major adverse limb events in a more readable and immediate format of the topic, to propose an overview of parameters to manage effectively peripheral artery disease patients and to propose basics of a new predictive tool to prevent from disabling vascular complications of the disease.
METHODS
Most recent and updated literature about the prevalence of major adverse limb events in peripheral artery disease was reviewed to identify possible main predictors.
RESULTS
In this article, we summarized major risk factors of limb revascularization failure and disabling vascular complications collecting those parameters principally responsible for major adverse limb events, which provides physio-pathological explanation of their role in peripheral artery disease.
CONCLUSION
We evaluated and listed a panel of possible predictors of MALE (Major Adverse Limb Event) in order to contribute to the development of a predictive score, based on a summary of the main risk factors reported in scientific articles, which could improve the management of peripheral artery disease by preventing vascular accidents.
PubMed: 36643723
DOI: 10.1016/j.athplu.2021.10.003