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The Clinical Journal of Pain Jan 2010To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the... (Review)
Review
OBJECTIVES
To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the Consolidated Standards of Reporting Trials (CONSORT) in 2001, the quality of published RCTs has improved. To improve reporting on adverse events, CONSORT expanded the section on harms (adverse events) in 2004. This paper evaluates whether the updated harms guidelines have been implemented in RCTs evaluating acupuncture for pain relief.
METHODS
Systematic searches were conducted using the following databases: MEDLINE, Allied & Complementary Medicine, Cumulative Index to Nursing & Allied Health Literature, and All EBM Reviews. Each database was searched from 2005 through 2008, corresponding to the availability of the updated harms guideline.
RESULTS
Ten studies met the inclusion criteria of this review. Six of the 10 studies mentioned or discussed adverse events. Four of the 6 studies did not detail how adverse events were collected. Only 2 studies discussed how adverse events were assessed.
DISCUSSION
On the basis of our findings, acupuncture clinical trials for pain reduction have yet to comprehensively meet CONSORT's guidelines for adverse event reporting. Acupuncture is commonly used by patients experiencing pain and although typically viewed as a benign and minimally invasive therapy, serious adverse events have been reported in the literature. To effectively and comprehensively document and understand these events, routine reporting according to CONSORT's harms guidelines should become the norm. Both science and patients are served by accurately evaluating the safety of acupuncture for patient populations experiencing pain.
Topics: Acupuncture Therapy; Databases, Bibliographic; Electromyography; Humans; Pain Management; Pain Measurement; Randomized Controlled Trials as Topic; Research Design; Retrospective Studies
PubMed: 20026952
DOI: 10.1097/AJP.0b013e3181b2c985 -
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 -
JACC. Cardiovascular Interventions Feb 2023
Topics: Humans; Percutaneous Coronary Intervention; Treatment Outcome; Coronary Artery Disease; Coronary Artery Bypass
PubMed: 36792255
DOI: 10.1016/j.jcin.2022.11.005 -
Studies in Health Technology and... Jun 2020Harms caused during healthcare encounters are pervasive and occur at an alarming rate; therefore, building a set of computational detection methodologies in the adverse...
Harms caused during healthcare encounters are pervasive and occur at an alarming rate; therefore, building a set of computational detection methodologies in the adverse event area is urgently needed to address this problem. To understand the entire range of adverse event detection methods currently in practice we have developed a computational adverse event detection matrix. This structure is made of methods used presently at US hospitals to detect patient safety events. It contains adverse event 1) concepts and 2) synthesized detection strategies as well as calculations of overlap of coded data in the subset of algorithms implemented completely computationally. Most importantly, this matrix provides a clear picture of coverage gaps in the detection of adverse events.
Topics: Adverse Drug Reaction Reporting Systems; Algorithms; Hospitals; Humans
PubMed: 32570358
DOI: 10.3233/SHTI200134 -
Urology Practice Mar 2024Medical misinformation regarding COVID-19 immunization remains rampant and a public concern, and as such, there is a need for national studies evaluating the... (Review)
Review
INTRODUCTION
Medical misinformation regarding COVID-19 immunization remains rampant and a public concern, and as such, there is a need for national studies evaluating the immunization's safety profile. We sought to quantify and analyze urologic adverse events and symptoms after COVID-19 immunization, compare these events reported between COVID-19 vaccine types, and compare these events reported following COVID-19 immunization relative to those reported following other immunizations.
METHODS
We conducted a retrospective case-control disproportionality analysis by querying the Food and Drug Administration Vaccine Adverse Event Reporting System for all reported symptoms following COVID-19 immunization through December 23, 2022, as well as for all non-COVID immunizations.
RESULTS
Using a total of 704,231 event reports containing 2,982,187 symptoms related to COVID vaccination and a total of 770,975 event reports containing 2,198,993 symptoms related to all vaccinations other than COVID-19 for disproportionality analysis, no urologic symptom produced a positive signal when grouping all vaccinations. When stratifying by manufacturer, some symptoms related to Janssen vaccination were positive, but this may be in part due to overreporting secondary to media attention rather than a strong association between Janssen vaccination and urologic adverse events.
CONCLUSIONS
Although there have been anecdotal reports of adverse events associated with the COVID-19 vaccine, our review of the Vaccine Adverse Event Reporting System database did not produce positive signals across all 4 measures for any potential adverse event. Our findings do not suggest increased scrutiny is required regarding these adverse events potentially related to the COVID-19 immunization. Further evaluation and analysis of the COVID-19 immunization is ongoing.
Topics: Humans; Adverse Drug Reaction Reporting Systems; COVID-19; COVID-19 Vaccines; Retrospective Studies; Vaccination; Urologic Diseases
PubMed: 38377155
DOI: 10.1097/UPJ.0000000000000497 -
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 -
BMC Medical Research Methodology Mar 2023Drug toxicity does not affect patients equally; the toxicity may only exert in patients who possess certain attributes of susceptibility to specific drug properties...
BACKGROUND
Drug toxicity does not affect patients equally; the toxicity may only exert in patients who possess certain attributes of susceptibility to specific drug properties (i.e., drug-host interaction). This concept is crucial for personalized drug safety but remains under-studied, primarily due to methodological challenges and limited data availability. By monitoring a large volume of adverse event reports in the postmarket stage, spontaneous adverse event reporting systems provide an unparalleled resource of information for adverse events and could be utilized to explore risk disparities of specific adverse events by age, sex, and other host factors. However, well-formulated statistical methods to formally address such risk disparities are currently lacking.
METHODS
In this paper, we present a statistical framework to explore spontaneous adverse event reporting databases for drug-host interactions and detect risk disparities in adverse drug events by various host factors, adapting methods for safety signal detection. We proposed four different methods, including likelihood ratio test, normal approximation test, and two tests using subgroup ratios. We applied our proposed methods to simulated data and Food and Drug Administration (FDA) Adverse Event Reporting Systems (FAERS) and explored sex-/age-disparities in reported liver events associated with specific drug classes.
RESULTS
The simulation result demonstrates that two tests (likelihood ratio, normal approximation) can detect disparities in adverse drug events associated with host factors while controlling the family wise error rate. Application to real data on drug liver toxicity shows that the proposed method can be used to detect drugs with unusually high level of disparity regarding a host factor (sex or age) for liver toxicity or to determine whether an adverse event demonstrates a significant unbalance regarding the host factor relative to other events for the drug.
CONCLUSION
Though spontaneous adverse event reporting databases require careful data processing and inference, the sheer size of the databases with diverse data from different countries provides unique resources for exploring various questions for drug safety that are otherwise impossible to address. Our proposed methods can be used to facilitate future investigation on drug-host interactions in drug toxicity using a large number of reported adverse events.
Topics: United States; Humans; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Pharmaceutical Preparations; Computer Simulation; Likelihood Functions; Databases, Factual
PubMed: 36973693
DOI: 10.1186/s12874-023-01885-w -
Advances in Therapy Jun 2022Iron deficiency (ID), with or without anemia, is commonly found worldwide and affects the health and wellbeing of pregnant and nonpregnant women. Symptoms of ID- which... (Review)
Review
Iron deficiency (ID), with or without anemia, is commonly found worldwide and affects the health and wellbeing of pregnant and nonpregnant women. Symptoms of ID- which include fatigue, pica (ice craving), restless legs syndrome, poor concentration and work function, increased susceptibility to infection, and cardiovascular stress- can cause significant morbidity and reduced quality of life. The etiologies of iron deficiency in women are usually specific to each community. In the developing world, iron deficiency is usually associated with poor iron intake and parasitic infections, whereas in higher income regions, iron deficiency is typically the result of heavy, abnormal uterine bleeding, and pregnancy. Iron-poor diets and poor iron absorption resulting from gut disorders can also play a role. Diagnosis of iron deficiency is usually straightforward and characterized by a low ferritin level; however, the diagnosis can be challenging in women with concomitant inflammatory disorders, in which case a low percent transferrin saturation, performed after an overnight fast, can inform on the need for iron. Therapy is frequently initiated with oral iron salts; however, use of these oral regimens is commonly associated with adverse events, mostly gastrointestinal in nature, that have been shown to adversely impact compliance, continuation, and the achievement of therapeutic goals. A further impediment to the effectiveness of oral iron is its poor absorption because of comorbidity (i.e., celiac disease, gastritis, etc.), surgery (bariatric), or physiologic inhibitory mechanisms. As such, intravenous (IV) iron regimens are increasingly being used to treat ID, as such regimens have been shown to avoid the gastrointestinal adverse events commonly associated with oral regimens. Indeed, IV iron has been shown to provide adequate iron replacement in women with functional iron deficiencies as well as those with ID resulting from inflammatory disorders- patients often resistant to oral iron therapy. More recent IV iron regimens have been shown to provide iron replacement in a safe and effective manner, being associated with more salutary adverse event profiles than earlier IV iron regimens. In fact, these iron regimens can provide a complete replacement dose in a single 15-60-min visit.
Topics: Anemia, Iron-Deficiency; Female; Humans; Iron; Iron Deficiencies; Pregnancy; Quality of Life; Women's Health
PubMed: 35488139
DOI: 10.1007/s12325-022-02157-7 -
Nurse Education Today Nov 2018This study was to investigate the differences in the types, frequency, and perspectives of self-reported adverse events reported following simulation encounters between...
OBJECTIVE
This study was to investigate the differences in the types, frequency, and perspectives of self-reported adverse events reported following simulation encounters between students enrolled in two Bachelor of Science in Nursing (BSN) programs: accelerated option (AO-BSN) or traditional (T-BSN) and by role (participant or observer) during simulation.
METHODS
This study analyzed 6994 adverse event reports entered by students through the simulated adverse event reporting system.
RESULTS
The AO-BSN students reported a higher percentage of adverse events coded as errors. In contrast the T-BSN students reported more near misses and sentinel events. Further, the T-BSN students significantly reported more fall related errors, while AO-BSN students reported more confidentiality breach errors. Participants reported more medication errors, whereas observers reported more airway and fall categorized errors.
CONCLUSION
The vantage from which adverse events are viewed and educational track appear to alter slightly the perceptions of the precipitating factors leading to committed or observed adverse events.
Topics: Attitude of Health Personnel; Education, Nursing, Baccalaureate; Humans; Medical Errors; Simulation Training; Students, Nursing
PubMed: 30145532
DOI: 10.1016/j.nedt.2018.08.016 -
Simulation in Healthcare : Journal of... Jun 2020System failures are contributing factors in the thousands of adverse events occurring in US healthcare institutions yearly. This study explored the premise that exposure...
INTRODUCTION
System failures are contributing factors in the thousands of adverse events occurring in US healthcare institutions yearly. This study explored the premise that exposure to a simulation experience designed to improve system thinking (ST) would impact adverse event reporting patterns.
METHODS
An intervention-control study was used to explore impacts of participation in a simulation designed to improve ST on adverse event reporting. Each summer Bachelor in Nursing Science students along with medical students participate in a week-long simulation-based interprofessional patient safety course. During the 2017 course, Friday Night in the ER, a table-top simulation designed to develop ST was included. As part of the school nursing's simulation program, students are asked to report adverse events observed or committed during simulation encounters into a simulated adverse event reporting system outside the simulation-based interprofessional patient safety course. Adverse event reporting system data were used to examine patterns of adverse event reporting in control and intervention groups studied.
RESULTS
Findings demonstrated differences in proportions of reported adverse events. The proportion of reported adverse events by students with the second and terminal semesters of course work combined and the 2016 and 2018 control groups combined demonstrated statistically significant differences, P < 0.001. Additional analysis revealed that the intervention group reported more medication-related events, whereas the control group reported more failure to rescue and airway-related events.
CONCLUSIONS
Exposure to a simulation designed to develop ST seems to impact adverse event reporting. These findings support the idea that ST may change safety monitoring behaviors.
Topics: Education, Medical; Education, Nursing; Humans; Interprofessional Relations; Patient Safety; Risk Management; Simulation Training; Systems Analysis
PubMed: 32487838
DOI: 10.1097/SIH.0000000000000473