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Cureus Sep 2022An adverse event is any abnormal clinical finding associated with the use of a therapy. Adverse events are classified by reporting an event's seriousness, expectedness,... (Review)
Review
An adverse event is any abnormal clinical finding associated with the use of a therapy. Adverse events are classified by reporting an event's seriousness, expectedness, and relatedness. Monitoring patient safety is of utmost importance as more and more data becomes available. In reality, very low numbers of adverse events are reported via the official path. Chart review, voluntary reporting, computerized surveillance, and direct observation can detect adverse drug events. Medication errors are commonly seen in hospitals and need provider and system-based interventions to prevent them. The need of the hour in India is to develop and implement medication safety best practices to avoid adverse events. The utility of artificial intelligence techniques in adverse event detection remains unexplored, and their accuracy and precision need to be studied in a controlled setting. There is a need to develop predictive models to assess the likelihood of adverse reactions while testing novel pharmaceutical drugs.
PubMed: 36258971
DOI: 10.7759/cureus.29162 -
International Journal of Environmental... Jun 2020Adverse events are common in healthcare. Three types of victims of patient-related adverse events can be identified. The first type includes patients and their families,... (Review)
Review
Adverse events are common in healthcare. Three types of victims of patient-related adverse events can be identified. The first type includes patients and their families, the second type includes healthcare professionals involved in an adverse event and the third type includes healthcare organisations in which an adverse event occurs. The purpose of this integrative review is to synthesise knowledge, theory and evidence regarding action after adverse events, based on literature published in the last ten years (2009-2018). In the studies critically evaluated ( = 25), key themes emerged relating to the first, second and third victim elements. The first victim elements comprise attention to revealing an adverse event, communication after an event, first victim support and complete apology. The second victim elements include second victim support types and services, coping strategies, professional changes after adverse events and learning about adverse event phenomena. The third victim elements consist of organisational action after adverse events, strategy, infrastructure and training and open communication about adverse events. There is a lack of comprehensive models for action after adverse events. This requires understanding of the phenomenon along with ambition to manage adverse events as a whole. When an adverse event is identified and a concern expressed, systematic damage preventing and ameliorating actions should be immediately launched. System-wide development is needed.
Topics: Adaptation, Psychological; Adolescent; Child; Communication; Cross-Sectional Studies; Health Personnel; Humans; Learning; Medical Errors; Middle Aged
PubMed: 32630041
DOI: 10.3390/ijerph17134717 -
The Laryngoscope Mar 2021Adverse events are common occurrences in hospitals that detract from quality of care. There are few data on errors in otolaryngology (ENT) and even fewer data comparing...
OBJECTIVES
Adverse events are common occurrences in hospitals that detract from quality of care. There are few data on errors in otolaryngology (ENT) and even fewer data comparing ENT to other services.
METHODS
We retrospectively reviewed adverse event data collected across a regional hospital network from July 2014 to August 2017. We examined categories of adverse events that occurred most commonly in ENT and compared the number of adverse events reported in ENT to those reported across all other departments. Descriptive analysis and the paired t test were used to analyze the data.
RESULTS
Two hundred ninety-one adverse events were reported in ENT departments during the period studied compared to 58,219 events reported across all other specialties. In ENT, the most commonly reported adverse events occurred in the perioperative setting, followed by issues regarding equipment and medical devices and, lastly, airway management. Across all other departments, the most common categories included medication and fluid errors, falls, and safety and security events. ENT departments had significantly higher proportions of perioperative and airway management errors and significantly lower proportions of events related to diagnosis and treatment (P = .004), falls (P < .001), lab results and specimens (P = .001), medication and fluids (P < .001), and safety and security (P < .001).
CONCLUSION
Perioperative and airway management errors occur with a statistically higher frequency in ENT compared to other in-patient and out-patient departments across hospitals. It is important to analyze adverse event reporting in surgical specialties to ensure the development of appropriate quality initiatives.
LEVEL OF EVIDENCE
4 Laryngoscope, 131:509-512, 2021.
Topics: Hospital Departments; Humans; Medicine; Otolaryngology; Retrospective Studies
PubMed: 35316544
DOI: 10.1002/lary.28861 -
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 -
Child and Adolescent Mental Health Sep 2023Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In... (Review)
Review
BACKGROUND
Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders.
METHOD
Medline, PsycINFO, Embase, ProQuest Dissertations and Theses Global, and the Cochrane Library were searched from January 2011-January 2023, and Google Scholar from January 2011-February 2023. English language experimental and quasi-experimental studies that evaluated the efficacy or effectiveness of psychosocial interventions for childhood mental disorders were included. Information on the definition, assessment, and report of adverse events was extracted using a checklist based on Good Clinical Practice guidelines.
RESULTS
In this review, 117 studies were included. Studies most commonly involved treating anxiety disorders or obsessive-compulsive disorder (32/117; 27%); 44% of the experimental interventions tested (52/117) were cognitive behavioral therapies. Adverse events were monitored in 36 studies (36/117; 31%) with a protocol used in 19 of these studies to guide monitoring (19/36; 53%). Twenty-seven different events were monitored across the studies with hospitalization the most frequently monitored (3/36; 8%). Event severity was fully assessed in 6 studies (17%) and partially assessed in 12 studies (33%). Only 4/36 studies (11%) included assessing events for cause.
CONCLUSIONS
To date, adverse events have been inconsistently defined, measured and reported in psychosocial intervention studies of childhood mental health disorders. Information on adverse events is an essential knowledge component for understanding the potential impacts and risks of therapeutic interventions.
Topics: Humans; Child; Psychotherapy; Cognitive Behavioral Therapy; Anxiety Disorders
PubMed: 37463769
DOI: 10.1111/camh.12661 -
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 -
Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review.Acta Obstetricia Et Gynecologica... May 2015Acupuncture within pregnancy has frequently been investigated, often finding this to be more effective than standard care. However, the adverse event severity, types and... (Review)
Review
BACKGROUND
Acupuncture within pregnancy has frequently been investigated, often finding this to be more effective than standard care. However, the adverse event severity, types and occurrence are unclear.
OBJECTIVE
To investigate the quality of reporting adverse events and to attempt to identify occurrence, type and severity of adverse events in acupuncture and non-acupuncture groups.
DATA SOURCES
MEDLINE, CINAHL, Allied and Complementary Medicine Database, and Physiotherapy Evidence Database (PEDro) were searched for relevant studies between 2000 and 2014.
STUDY SELECTION
Seventeen studies using penetrating acupuncture and making comment on adverse events experienced were included. Quality appraisal of the selected publications was performed using either the PEDro scale or the Downs and Black checklist. Quality of reporting was evaluated against STRICTA and CONSORT guidelines, with data on adverse events extracted in accordance with CONSORT and Good Clinical Practice adverse event guidelines.
RESULTS
Overall quality of reporting of adverse events was poor, with information describing the adverse events often lacking in detail. A number of trends were noted: adverse events occurring within a treatment session was 3-17% in the acupuncture groups and 4-25% in the non-acupuncture groups. The percentage of women affected by an adverse event was between 14 and 17% in the acupuncture groups and between 15 and 19% in non-acupuncture groups.
CONCLUSIONS
Adverse event reporting within acupuncture trials is generally poor. The trends noted were that adverse events do occur, but would appear to be largely minor and comparable to non-acupuncture-related interventions.
Topics: Acupuncture Therapy; Female; Humans; Pregnancy; Pregnancy Complications; Research Design
PubMed: 25603694
DOI: 10.1111/aogs.12587 -
Journal of Psychiatric Research May 2024Neuromodulatory interventions are relatively novel and approaches to studying harms and tolerability have varied. Using a checklist based on guidelines from Good... (Review)
Review
Neuromodulatory interventions are relatively novel and approaches to studying harms and tolerability have varied. Using a checklist based on guidelines from Good Clinical Practice and the Harms Extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement, we identified how adverse events are measured, assessed, and reported in studies evaluating neuromodulation for the treatment of mental and neurodevelopmental disorders among children and adolescents. A systematic literature review identified 56 experimental and quasi-experimental studies evaluating transcranial magnetic stimulation (TMS), transcranial alternating (tACS) or direct (tDCS) current stimulation, transcranial pulse stimulation (TPS), and vagus or trigeminal nerve stimulation (VNS or TNS). For 22 studies (39%), the types of adverse events to be monitored were identified, and for 31 studies (55%), methods for collecting adverse event data were described. Methods for assessing adverse events were less commonly described with 23 studies (41%) having details on assessing event severity, and 11 studies (20%) having details on assessing event causality. Among 31 studies with reported results, headache, skin irritation, and general pain or discomfort were the most reported across studies. Seizure, untoward medical occurrences, and intracranial bleeding, edema, or other intracranial pathology were considered serious events, but these events were not reported as occurring in any results-based papers. Taken together, the findings from this review indicate that most studies of pediatric neuromodulatory interventions did not include descriptions of adverse event monitoring and evaluation. Comprehensive event monitoring and reporting across studies can significantly augment the current knowledge base.
PubMed: 38761518
DOI: 10.1016/j.jpsychires.2024.05.035 -
Journal of Patient Safety Dec 2020Reporting of adverse and near miss events are essential to identify system level targets to improve patient safety. Resident physicians historically report few events...
OBJECTIVES
Reporting of adverse and near miss events are essential to identify system level targets to improve patient safety. Resident physicians historically report few events despite their role as front-line patient care providers. We sought to evaluate barriers to adverse event reporting in an effort to improve reporting. Our main outcomes were as follows: resident attitudes about event reporting and the frequency of event reporting before and after interventions to address reporting barriers.
METHODS
We surveyed first year residents regarding barriers to adverse event reporting and used this input to construct a fishbone diagram listing barriers to reporting. Barriers were addressed, and resident event reporting was compared before and after efforts were made to reduce obstacles to reporting.
RESULTS
First year residents (97%) recognized the importance of submitting event reports; however, the majority (85%) had not submitted an event report in the first 6 months of residency. Only 7% of residents specified that they had not witnessed an adverse event in 6 months, whereas one third had witnessed 10 or more events. The main barriers were as follows: lack of knowledge about how to submit events (38%) and lack of time to submit reports (35%). After improving resident education around event reporting and simplifying the reporting process, resident event reporting increased 230% (68 to 154 annual reports, P = 0.025).
CONCLUSIONS
We were able to significantly increase resident event reporting by educating residents about adverse events and near misses and addressing the primary barriers to event reporting. Moving forward, we will continue annual resident education about patient safety, focus on improving feedback to residents who submit reports, and empower senior residents to act as role models to junior residents in patient safety initiatives.
Topics: Humans; Medical Errors; Patient Safety; Risk Management; Surveys and Questionnaires
PubMed: 29028690
DOI: 10.1097/PTS.0000000000000333 -
Southern African Journal of Infectious... 2023The reporting of adverse drug reactions associated with drug-resistant tuberculosis (DR-TB) medication is important for pharmacovigilance, especially in high-burden...
BACKGROUND
The reporting of adverse drug reactions associated with drug-resistant tuberculosis (DR-TB) medication is important for pharmacovigilance, especially in high-burden countries such as South Africa. With DR-TB treatment being so dynamic, it is important to understand adverse event reporting practices at specialised facilities.
OBJECTIVES
The study aimed to understand the adverse drug reaction (ADR) reporting practices at DR-TB treatment facilities in South Africa.
METHOD
Interviews were conducted with healthcare workers at specialised DR-TB facilities. This was to collect data on demographics, pharmacovigilance training, and determine attitudes and practices towards reporting adverse events. A checklist was developed to review the most recent adverse event forms captured at the facility.
RESULTS
Most participants did not have adverse event reporting training since their initial training but were confident that they could complete a form themselves. Most participants could correctly identify the major adverse events associated with DR-TB medication, but some deemed non-adverse events as plausible. Adverse event report forms were not standardised with most participants deeming further training and regular feedback as reasons to report ADRs.
CONCLUSION
Standardisation of adverse event report forms used and the establishment of regular reporting will increase adverse event reporting at DR-TB facilities. Continuous training, empowerment and expansion of staff categories eligible to report adverse events will enhance and sustain such practice.
CONTRIBUTION
The study highlights challenges faced by healthcare professionals in reporting adverse events.
PubMed: 38223433
DOI: 10.4102/sajid.v38i1.564