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Journal of Diabetes Science and... Sep 2022Unlike performance evaluations, which are often conducted under ideal conditions, adverse events occur during actual device use for people with diabetes. This report...
Unlike performance evaluations, which are often conducted under ideal conditions, adverse events occur during actual device use for people with diabetes. This report summarizes the number of adverse events for the years 2018 to 2020 for the 3 diabetes devices: blood glucose meters (BG), continuous glucose monitors (CGM), and insulin pumps. A text example of a CGM injury is provided. Possible reasons are suggested for trends. Whereas the rate per test result (events/usage) is exceedingly small, the rate per patient (events/people with diabetes that use insulin) is of concern. Hence, it is important to determine event causes and provide corrective actions. The first step is to put in place routine analysis of adverse event data for diabetes devices.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 1; Humans; Hypoglycemic Agents; Insulin; Insulin Infusion Systems; Insulins
PubMed: 33969718
DOI: 10.1177/19322968211011688 -
Biomedica : Revista Del Instituto... Mar 2022Introduction: Adverse events can cause harm to the patient, but they also affect health professionals making them second victims of the event. Interventions have been...
Introduction: Adverse events can cause harm to the patient, but they also affect health professionals making them second victims of the event. Interventions have been focused mostly on patients, but little on professionals, probably due to lack of tools. Objective: To estimate the prevalence of adverse events and describe their manifestations in healthcare personnel to evidence the phenomenon of second victims in a highly complex hospital. Materials and methods: We conducted an analytical cross-sectional study by a survey of 419 healthcare professionals from the hospitalization, emergency, and surgical areas in a highly complex hospital in Medellín in 2019. The frequency of adverse events was estimated and its association with some labor and demographic variables was determined. Results: We found that 93.1% of the participants knew of incident cases and 79% of serious adverse events while 44.4% had been involved in them and 99% of these had feelings as a second victim, mainly the difficulty to concentrate, guilt, fatigue, anxiety, and doubts about decisions; 95% indicated they wanted to receive training to face the consequences of adverse events and know how to inform the patient. Conclusions: Health professionals are frequently exposed to adverse events that can cause negative emotions in them such as guilt, fatigue, anxiety, and insecurity. Most professionals who participate in an adverse event express feelings as a second victim. Informing the patient about an adverse event requires preparation and most professionals requested training on the subject.
PubMed: 35471180
DOI: 10.7705/biomedica.6169 -
BMJ Quality & Safety Mar 2021Understanding adverse events among children treated in the emergency department (ED) offers an opportunity to improve patient safety by providing evidence of where to...
BACKGROUND
Understanding adverse events among children treated in the emergency department (ED) offers an opportunity to improve patient safety by providing evidence of where to focus efforts in a resource-restricted environment.
OBJECTIVE
To estimate the risk of adverse events, their type, preventability and severity, for children seen in a paediatric ED.
METHODS
This prospective cohort study examined outcomes of patients presenting to a paediatric ED over a 1-year period. The primary outcome was the proportion of patients with an adverse event (harm to patient related to healthcare received) related to ED care within 3 weeks of their visit. We conducted structured telephone interviews with all patients and families over a 3-week period following their visit to identify flagged outcomes (such as repeat ED visits, worsening symptoms) and screened admitted patients' health records with a validated trigger tool. For patients with flagged outcomes or triggers, three ED physicians independently determined whether an adverse event occurred.
RESULTS
Of 1567 eligible patients, 1367 (87.2%) were enrolled and 1319 (96.5%) reached in follow-up. Median patient age was 4.34 years (IQR 1.5 to 10.57 years) and most (n=1281; 93.7%) were discharged. Among those with follow-up, 33 (2.5%, 95% CI 1.8% to 3.5%) suffered an adverse event related to ED care. None experienced more than one event. Twenty-nine adverse events (87.9%, 95% CI 72.7% to 95.2%) were deemed preventable. The most common types of adverse events (not mutually exclusive) were management issues (51.5%), diagnostic issues (45.5%) and suboptimal follow-up (15.2%).
CONCLUSION
One in 40 children suffered adverse events related to ED care. A high proportion of events were preventable. Management and diagnostic issues warrant further study.
Topics: Child; Child, Preschool; Emergency Service, Hospital; Humans; Infant; Patient Discharge; Patient Safety; Physicians; Prospective Studies
PubMed: 32350128
DOI: 10.1136/bmjqs-2019-010055 -
Cardio-oncology (London, England) Jul 2022Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These... (Review)
Review
Reports of cardiac adverse events from oncology clinical trials often are at variance with reports derived from clinical observations or data-base reviews. These differences may lead to confusion, as different levels of risks abound in the literature, and the true cardiac risk of using some agents is uncertain. Additionally, such discrepancies may lead to the creation of over-cautious surveillance algorithms. Reasons for these reported differences are complex and often reflect subtleties in the criteria for individual patient evaluation. Both clinical trial data and real-world data have potential flaws that make reconciliation problematic. Importantly, however, both provide crucial information regarding the risk of adverse events. Major factors contribute to these differences including different tools used to diagnose events, and how those tools are interpreted. Additionally, differences in the populations of clinical trial participants and real-world populations play a crucial role. This paper looks at these differences and provides a perspective intended to help clinicians interpret reported variations in event rates derived from highly scrutinized clinical trials and broader real-world data.
PubMed: 35854393
DOI: 10.1186/s40959-022-00139-w -
Drugs - Real World Outcomes Jun 2021Small molecule tyrosine kinase inhibitors (TKIs) inhibit not only the target kinase but also various kinases as off-target inhibitors not mentioned in the package...
INTRODUCTION
Small molecule tyrosine kinase inhibitors (TKIs) inhibit not only the target kinase but also various kinases as off-target inhibitors not mentioned in the package insert. However, there are no reports that comprehensively examine the relationship between adverse events and kinase affinity.
OBJECTIVE
In this study, we combined basic data and clinical data to visualize the relationship between kinase affinity and adverse events, which will be useful for the management of adverse events in clinical practice.
METHODS
We targeted TKIs that have been used domestically and for which the dissociation constant was obtained as reported by Davis et al. Adverse event data recorded in the Japanese Adverse Drug Event Report (JADER) database provided by the Pharmaceuticals and Medical Devices Agency between April 2004 and January 2018 were used. We calculated the reporting rates of the Standardized MedDRA Queries (SMQ) for the adverse events of interest and visualized the correlation coefficients with kinase affinity. We used the adverse events associated with VEGFR2 and EGFR to assess their validity.
RESULTS
We found a correlation among known kinase-related adverse events, suggesting that the methodology may be used as a signal detection method to generate hypotheses for clinical and basic research.
CONCLUSION
Our comprehensive analysis of the kinase affinity of TKIs in this study, which was based on basic TKI kinase affinity data and the clinical data of the reporting rates, suggested that our comprehensive analysis method is useful for generating hypotheses about possible causal relationships between pharmacological effects and adverse events.
PubMed: 33686612
DOI: 10.1007/s40801-021-00235-w -
BMC Research Notes Sep 2015We previously reported on the change in the use of rosiglitazone-containing products (RCP) and adverse event reporting rates in Canadian patients between 2004 and 2010....
BACKGROUND
We previously reported on the change in the use of rosiglitazone-containing products (RCP) and adverse event reporting rates in Canadian patients between 2004 and 2010. The present study extends this analysis to include the January 2011 to December 2012 time period.
METHODS
RCP utilization rates were obtained from IMS Health Brogan's longitudinal de-identified patient database, LRx. GlaxoSmithKline's global adverse events database was used to extract adverse events (AE), serious adverse events (SAE), and cardiac adverse events (CAE) reported in Canadian patients receiving RCP from April 2004 to December 2012. The patient utilization information from the LRx database was used to estimate rates per 100,000 patients.
RESULTS
An estimated 182,841 patients were dispensed RCP prescriptions between April 2004 and December 2012. The total number of patients using RCP decreased by 85% from 2011 to 2012. From its peak use in 2007, the number of patients filling a prescription decreased 97%. A total of 1069 AEs were reported during the study period, of which 32 AE's were reported from Jan 2011 to Dec 2012. The average monthly reporting rates of AE's, SAE's and CAE's over 2011-2012 were 10.8/100,000 patients, 9.1/100,000 patients and 5.0/100,000 patients, respectively.
CONCLUSIONS
The utilization of RCP in Canada has significantly declined. The significance of the adverse event rate information presented is uncertain and must be evaluated within the context of the well known factors that can influence AE reporting rates, as well as limitations to the methods used to estimate these reporting rates.
Topics: Canada; Humans; Rosiglitazone; Thiazolidinediones; Time Factors
PubMed: 26419903
DOI: 10.1186/s13104-015-1448-6 -
Dentistry Journal Jul 2023Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have...
Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have risen in popularity among the general public and sparked debate among dental professionals. Dental professionals argue that using these aligners without an in-person diagnosis and treatment planning protocol set by a licensed dentist or orthodontist may lead to adverse effects on teeth and surrounding structures. The objective of this study is to describe adverse clinical events associated with the use of DTC sequential aligners as reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA MAUDE) database. Methods-We searched the MAUDE database from 1 January 2010 to 31 December 2020 for the product code of 'NXC' (sequential aligners). The year, type of adverse event, reporter occupation, and event description were noted. Results-651 reports associated with sequential aligners were found, of which 104 were related to DTC sequential aligners. Fifty-four adverse events were reported in 2019. From the event description, 41.3% comprised bite problems, 29.8% comprised orofacial pain, and 26.6% of patients had some form of periodontal sequelae. Furthermore, 69.2% of the patients followed up after an adverse event with a dentist not associated with DTC aligners. Conclusions-The use of DTC sequential aligners without dental supervision has led to oral health problems, as documented in the MAUDE database. Commonly reported adverse events include bite problems, pain, sensitivity, and periodontal disease, and some adverse events are irreversible.
PubMed: 37504239
DOI: 10.3390/dj11070174 -
The Journal of Dermatological Treatment Dec 2023Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure.
Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest.
BACKGROUND
Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure.
OBJECTIVES
To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and the number needed to harm (NNH) for one adverse event of special interest (AESI) to occur.
METHODS
Pooled analysis from two randomized controlled trials in patients with moderate-to-severe plaque psoriasis ( = 1800). PSOLAR registry was used as safety reference data for NNH estimation.
RESULTS
Rates of AESI with tildrakizumab were comparable with rates reported in PSOLAR. The NNH for one-year severe infection occurrence was 412 with tildrakizumab 200 mg, and negative for tildrakizumab 100 mg due to lower rates in reSURFACE trials; the NNH for malignancy was 990 for one year with tildrakizumab 100 mg (negative for tildrakizumab 200 mg); and the NNH for major adverse cardiovascular events was 355 for one year with tildrakizumab 200 mg (negative for tildrakizumab 100 mg).
CONCLUSION
Tildrakizumab demonstrated a favorable safety profile over 5 years with low rates of AESI, comparable to those of the PSOLAR. Consequently, the NNH for AESI with tildrakizumab were very high or negative due to lower event rates for tildrakizumab.
Topics: Humans; Antibodies, Monoclonal, Humanized; Patients; Psoriasis; Registries
PubMed: 37341303
DOI: 10.1080/09546634.2023.2220447 -
Dermatological Aspects of Nursing Oncology: Meaningful Observations Ensuring Better Quality of Life.Indian Journal of Palliative Care 2022Modern cancer management has changed over the period of time and now shifted to multidisciplinary care approach to ensure a better quality of life (QOL) of the surfing... (Review)
Review
Modern cancer management has changed over the period of time and now shifted to multidisciplinary care approach to ensure a better quality of life (QOL) of the surfing patients. Every form of cancer treatment has side effects and affects the QOL. Many of the side effects have been discussed in detail because of the need for timely interventions to prevent the consequences of the side effects. Dermatological adverse events due to cancer treatment are important but most commonly ignored in our clinical practice. Nursing staffs have a critical role in the early identification of such events and by briefing and training of the nursing staff in the identification of adverse events which can aid in the prevention of complications. As dermatologists may not be available round the clock, nursing staff are looking after the patients round the clock can prove very vital in screening cutaneous AE and adequately setting up referrals to aid early recognition and treatment of not only mild but also potentially life-threatening complications. The nursing staff, which is a cadre of health caregivers that are intimately involved in cancer care, can be trained to identify timely, skin-related adverse events. A literature search of scientific publications was done using the electronic databases PubMed, Science Direct, Cochrane Library, and Google Scholar. The search included terms 'Adverse events (AEs) post-chemotherapy,' 'AE post-radiotherapy,' 'AE post-immunotherapy,' 'AE post-hormonal therapy for cancer' and 'AE post-cancer surgery.' Data obtained from these studies and case reports were compiled and interpreted to prepare this review. This review focuses on various ways in which skin can be involved adversely as a part of cancer management and their classic and tell-tale signs to help the nurses in their better and quicker identification so that dermatologists are timely intimated and the treatment can be instituted to improve the patient's QOL.
PubMed: 35673687
DOI: 10.25259/IJPC_147_2021