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JACC. Cardiovascular Imaging Jul 2018
Topics: Humans; Machine Learning; Myocardial Perfusion Imaging; Prognosis; Tomography, Emission-Computed, Single-Photon
PubMed: 29055636
DOI: 10.1016/j.jcmg.2017.07.025 -
PloS One 2022Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are... (Review)
Review
INTRODUCTION
Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are many reports of adverse events (or undesirable outcomes) following such interventions, there is no common definition for an adverse event or clarity on any severity classification. This impedes advances of patient safety initiatives and practice. This scoping review mapped the evidence of adverse event definitions and classification systems following spinal and peripheral joint manipulation and mobilization for musculoskeletal conditions in adults.
METHODS
An electronic search of the following databases was performed from inception to February 2021: MEDLINE, EMBASE, CINAHL, Scopus, AMED, ICL, PEDro, Cochrane Library, Open Grey and Open Theses and Dissertations. Studies including adults (18 to 65 years old) with a musculoskeletal condition receiving spinal or peripheral joint manipulation or mobilization and providing an adverse event definition and/or classification were included. All study designs of peer-reviewed publications were considered. Data from included studies were charted using a standardized data extraction form and synthesised using narrative analysis.
RESULTS
From 8248 identified studies, 98 were included in the final synthesis. A direct definition for an adverse event and/or classification system was provided in 69 studies, while 29 provided an indirect definition and/or classification system. The most common descriptors to define an adverse event were causality, symptom severity, onset and duration. Twenty-three studies that provided a classification system described only the end anchors (e.g., mild/minor and/or serious) of the classification while 26 described multiple categories (e.g., moderate, severe).
CONCLUSION
A vast array of terms, definition and classification systems were identified. There is no one common definition or classification for adverse events following spinal and peripheral joint manipulation and mobilization. Findings support the urgent need for consensus on the terms, definition and classification system for adverse events related to these interventions.
Topics: Adolescent; Adult; Aged; Humans; Manipulation, Spinal; Middle Aged; Musculoskeletal Diseases; Young Adult
PubMed: 35839253
DOI: 10.1371/journal.pone.0270671 -
Current Hematologic Malignancy Reports Apr 2021Reporting of adverse events on hematology clinical trials is crucial to understanding the safety of standard treatments and novel agents. However, despite the importance... (Review)
Review
PURPOSE OF REVIEW
Reporting of adverse events on hematology clinical trials is crucial to understanding the safety of standard treatments and novel agents. However, despite the importance of understanding toxicities, challenges in capturing and reporting accurate adverse event data exist.
RECENT FINDINGS
Currently, adverse events are reported manually on most hematology clinical trials. Especially on phase III trials, the highest grade of each adverse event during a reporting period is typically reported. Despite the effort committed to AE reporting, studies have identified underreporting of adverse events on hematologic malignancy clinical trials, which raises concern about the true understanding of safety of treatment that clinicians have in order to guide patients about what to expect during therapy. In order to address these concerns, recent studies have piloted alternative methods for identification of adverse events. These methods include automated extraction of adverse event data from the electronic health record, implementation of trigger or alert tools into the medical record, and analytic tools to evaluate duration of adverse events rather than only the highest adverse event grade. Adverse event reporting is a crucial component of clinical trials. Novel tools for identifying and reporting adverse events provide opportunities for honing and refining methods of toxicity capture and improving understanding of toxicities patients experience while enrolled on clinical trials.
Topics: Clinical Trials as Topic; Delivery of Health Care; Drug-Related Side Effects and Adverse Reactions; Hematologic Diseases; Humans; Quality Improvement; Risk Management
PubMed: 33786724
DOI: 10.1007/s11899-021-00627-3 -
Journal of Ophthalmic Inflammation and... Feb 2023Immune checkpoint inhibitors (ICIs) have become an important part of the treatment of multiple cancers, especially for advanced melanoma and non-small cell lung cancer.... (Review)
Review
INTRODUCTION
Immune checkpoint inhibitors (ICIs) have become an important part of the treatment of multiple cancers, especially for advanced melanoma and non-small cell lung cancer. Some tumors are capable of escaping immunosurveillance by stimulating checkpoints on T-cells. ICIs prevent activation of these checkpoints and thereby stimulate the immune system and indirectly the anti-tumor response. However, the use of ICIs is associated with various adverse events. Ocular side effects are rare but may have a major impact on the quality of life of the patient.
METHODS
A comprehensive literature search of the medical databases Web of Science, Embase and PubMed was performed. Articles that provided a comprehensive description of a case report containing 1) cancer patient(s) treated with (a combination of) immune checkpoint inhibitors, and 2) assessed occurrence of ocular adverse events, were included. A total of 290 case reports were included.
RESULTS
Melanoma (n = 179; 61.7%) and lung cancer (n = 56; 19.3%) were the most frequent reported malignancies. The primary used ICIs were nivolumab (n = 123; 42.5%) and ipilimumab (n = 116; 40.0%). Uveitis was most the common adverse event (n = 134; 46.2%) and mainly related to melanoma. Neuro-ophthalmic disorders, including myasthenia gravis and cranial nerve disorders, were the second most common adverse events (n = 71; 24.5%), mainly related to lung cancer. Adverse events affecting the orbit and the cornea were reported in 33 (11.4%) and 30 cases (10.3%) respectively. Adverse events concerning the retina were reported in 26 cases (9.0%).
CONCLUSION
The aim of this paper is to provide an overview of all reported ocular adverse events related to the use of ICIs. The insights retrieved from this review might contribute to a better understanding of the underlying mechanisms of these ocular adverse events. Particularly, the difference between actual immune-related adverse events and paraneoplastic syndromes might be relevant. These findings might be of great value in establishing guidelines on how to manage ocular adverse events related to ICIs.
PubMed: 36811715
DOI: 10.1186/s12348-022-00321-2 -
Journal of the American Dental... May 2015Errors are commonplace in health care, including dentistry. It is imperative for dental professionals to intercept errors before they lead to an adverse event and to... (Review)
Review
BACKGROUND
Errors are commonplace in health care, including dentistry. It is imperative for dental professionals to intercept errors before they lead to an adverse event and to mitigate their effects when an adverse event occurs. This requires a systematic approach at both the profession level, encapsulated in the Agency for Healthcare Research and Quality's patient safety initiative framework, as well as at the practice level, in which crew resource management is a tested paradigm. Supporting patient safety at both the profession and dental practice levels relies on understanding the types and causes of errors, which have not been well studied.
METHODS
The authors performed a retrospective review of dental adverse events reported in the literature. Electronic bibliographic databases were searched, and data were extracted on background characteristics, incident description, case characteristics, clinic setting where adverse event originated, phase of patient care that adverse event was detected, proximal cause, type of patient harm, degree of harm, and recovery actions.
RESULTS
The authors identified 182 publications (containing 270 cases) through their search. Delayed treatment, unnecessary treatment, or disease progression after misdiagnosis was the largest type of harm reported. Of the reviewed cases, 24.4% of those patients involved in an adverse event experienced permanent harm. One of every 10 case reports reviewed (11.1%) reported that the adverse event resulted in the death of the affected patient.
CONCLUSIONS
Published case reports provide a window into understanding the nature and extent of dental adverse events; however, the overall dearth of publications on adverse events in the dental literature points to the need for more study.
PRACTICAL IMPLICATIONS
Siloed and incomplete contributions to dentistry's understanding of adverse events in the dental office are threats to dental patients' safety. Publishing more, and more comprehensive, case reports on adverse events is recommended for dental practitioners.
Topics: Dental Care; Humans; Medical Errors; Patient Safety; Periodicals as Topic
PubMed: 25925524
DOI: 10.1016/j.adaj.2015.01.003 -
Epilepsy Research Aug 2022There have been several reports that switching formulations of antiseizure medications (ASMs) has been associated with a deterioration of seizure control, seizure...
There have been several reports that switching formulations of antiseizure medications (ASMs) has been associated with a deterioration of seizure control, seizure relapse or increased adverse effects. Considering recent findings that excipients, namely purported inactive ingredients, may nevertheless exert biological effects, it is possible that the variation in adverse event profile of antiseizure drugs may be related to differences in excipients. To test our hypothesis, we constructed a new research tool to connect FDA-compiled adverse event reports to the excipient in the medicine. Analysis of adverse events to formulations of five different second-generation antiseizure drugs - gabapentin, lamotrigine, levetiracetam, oxcarbazepine, and topiramate - showed several significant associations between specific excipient in the formulations and an adverse event when compared to the same medicine formulated with other excipients. Epilepsy and seizure adverse events were associated with multiple excipients across gabapentin, lamotrigine, and levetiracetam formulations. A different group of excipients were associated with reports of hypersensitivity reactions including urticaria, rash, erythema, and Stevens-Johnson syndrome. Our study provides a novel approach to analyzing post-market surveillance reports by including excipients. It may be useful to clinicians when evaluating select patient groups that may be refractory to pharmacological treatment or experience worsening adverse events when switching formulations of the same antiseizure medicine.
Topics: Anticonvulsants; Drug Compounding; Excipients; Gabapentin; Humans; Lamotrigine; Levetiracetam; Seizures
PubMed: 35661571
DOI: 10.1016/j.eplepsyres.2022.106947 -
JACC. CardioOncology Dec 2022T-cell therapies, such as chimeric antigen receptor (CAR) T-cell, bispecific T-cell engager (BiTE) and tumor-infiltrating lymphocyte (TIL) therapies, fight cancer cells... (Review)
Review
T-cell therapies, such as chimeric antigen receptor (CAR) T-cell, bispecific T-cell engager (BiTE) and tumor-infiltrating lymphocyte (TIL) therapies, fight cancer cells harboring specific tumor antigens. However, activation of the immune response by these therapies can lead to a systemic inflammatory response, termed cytokine release syndrome (CRS), that can result in adverse events, including cardiotoxicity. Retrospective studies have shown that cardiovascular complications occur in 10% to 20% of patients who develop high-grade CRS after CAR T-cell therapy and can include cardiomyopathy, heart failure, arrhythmias, and myocardial infarction. While cardiotoxicities have been less commonly reported with BiTE and TIL therapies, systematic surveillance for cardiotoxicity has not been performed. Patients undergoing T-cell therapies should be screened for cardiovascular conditions that may not be able to withstand the hemodynamic perturbations imposed by CRS. Generalized management of CRS, including the use of the interleukin-6 antagonist, tocilizumab, for high-grade CRS, is used to mitigate the risk of cardiotoxicity.
PubMed: 36636447
DOI: 10.1016/j.jaccao.2022.07.014 -
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 -
Clinical Trials (London, England) Apr 2016Tragedies suggest that phase I trials in healthy participants may be highly risky. This possibility raises concern that phase I trials may exploit healthy participants... (Review)
Review
BACKGROUND/AIMS
Tragedies suggest that phase I trials in healthy participants may be highly risky. This possibility raises concern that phase I trials may exploit healthy participants to develop new therapies, making the translation of scientific discoveries ethically worrisome. Yet, few systematic data evaluate this concern. This article systematically reviews the risks of published phase I trials in healthy participants and evaluates trial features associated with increased risks.
METHODS
Data on adverse events and trial characteristics were extracted from all phase I trials published in PubMed, Embase, Cochrane, Scopus, and PsycINFO (1 January 2008-1 October 2012). Inclusion criteria were phase I studies that enrolled healthy participants of any age, provided quantitative adverse event data, and documented the number of participants enrolled. Exclusion criteria included (1) adverse event data not in English, (2) a "challenge" study in which participants were administered a pathogen, and (3) no quantitative information about serious adverse events. Data on the incidence of adverse events, duration of adverse event monitoring, trial agent tested, participant demographics, and trial location were extracted.
RESULTS
In 475 trials enrolling 27,185 participants, there was a median of zero serious adverse events (interquartile range = 0-0) and a median of zero severe adverse events (interquartile range = 0-0) per 1000 treatment group participants/day of monitoring. The rate of mild and moderate adverse events was a median of 1147.19 per 1000 participants (interquartile range = 651.52-1730.9) and 46.07 per 1000 participants/adverse event monitoring day (interquartile range = 17.80-77.19).
CONCLUSION
We conclude that phase I trials do cause mild and moderate harms but pose low risks of severe harm. To ensure that this conclusion also applies to unpublished trials, it is important to increase trial transparency.
Topics: Adolescent; Adult; Clinical Trials, Phase I as Topic; Female; Healthy Volunteers; Humans; Male; Middle Aged; Risk Assessment; Young Adult
PubMed: 26350571
DOI: 10.1177/1740774515602868 -
Journal of Diabetes Science and... Jun 2023Adverse events for continuous glucose monitors (CGMs) represent a significant issue for people with diabetes with 281 963 CGM adverse events occurring in 2022. The...
BACKGROUND
Adverse events for continuous glucose monitors (CGMs) represent a significant issue for people with diabetes with 281 963 CGM adverse events occurring in 2022. The process to obtain adverse events and the US Food and Drug Administration (FDA) database that contains them are reviewed.
METHODS
Tables were created in SQL Server for four CGM products (Dexcom G6, all versions of Abbott Libre, Medtronic Guardian 3, and Senseonics Eversense) containing either malfunction or injury adverse events sorted by the manufacturer's chosen product code. As the product code is not always clear (or appropriate), the causes of the events were determined from the text description of the adverse event. The resulting causes were listed in decreasing order in tables for each product and event type.
RESULTS
A common effect of several event causes prevented the user from obtaining a result. Inaccuracy was also a frequent complaint. Other causes were specific to that device.
CONCLUSIONS
Creating tables based on manufacturer problem codes for their CGMs, followed by analysis of the adverse event text, facilitates the analysis of event causes. Analyzing adverse event data is the first step in trying to reduce the number of adverse events.
PubMed: 37264590
DOI: 10.1177/19322968231178525