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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 Cochrane Database of Systematic... Oct 2017Chronic pain is common and can be challenging to manage. Despite increased utilisation of opioids, the safety and efficacy of long-term use of these compounds for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic pain is common and can be challenging to manage. Despite increased utilisation of opioids, the safety and efficacy of long-term use of these compounds for chronic non-cancer pain (CNCP) remains controversial. This overview of Cochrane Reviews complements the overview entitled 'High-dose opioids for chronic non-cancer pain: an overview of Cochrane Reviews'.
OBJECTIVES
To provide an overview of the occurrence and nature of adverse events associated with any opioid agent (any dose, frequency, or route of administration) used on a medium- or long-term basis for the treatment of CNCP in adults.
METHODS
We searched the Cochrane Database of Systematic Reviews (the Cochrane Library) Issue 3, 2017 on 8 March 2017 to identify all Cochrane Reviews of studies of medium- or long-term opioid use (2 weeks or more) for CNCP in adults aged 18 and over. We assessed the quality of the reviews using the AMSTAR criteria (Assessing the Methodological Quality of Systematic Reviews) as adapted for Cochrane Overviews. We assessed the quality of the evidence for the outcomes using the GRADE framework.
MAIN RESULTS
We included a total of 16 reviews in our overview, of which 14 presented unique quantitative data. These 14 Cochrane Reviews investigated 14 different opioid agents that were administered for time periods of two weeks or longer. The longest study was 13 months in duration, with most in the 6- to 16-week range. The quality of the included reviews was high using AMSTAR criteria, with 11 reviews meeting all 10 criteria, and 5 of the reviews meeting 9 out of 10, not scoring a point for either duplicate study selection and data extraction, or searching for articles irrespective of language and publication type. The quality of the evidence for the generic adverse event outcomes according to GRADE ranged from very low to moderate, with risk of bias and imprecision being identified for the following generic adverse event outcomes: any adverse event, any serious adverse event, and withdrawals due to adverse events. A GRADE assessment of the quality of the evidence for specific adverse events led to a downgrading to very low- to moderate-quality evidence due to risk of bias, indirectness, and imprecision.We calculated the equivalent milligrams of morphine per 24 hours for each opioid studied (buprenorphine, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, levorphanol, methadone, morphine, oxycodone, oxymorphone, tapentadol, tilidine, and tramadol). In the 14 Cochrane Reviews providing unique quantitative data, there were 61 studies with a total of 18,679 randomised participants; 12 of these studies had a cross-over design with two to four arms and a total of 796 participants. Based on the 14 selected Cochrane Reviews, there was a significantly increased risk of experiencing any adverse event with opioids compared to placebo (risk ratio (RR) 1.42, 95% confidence interval (CI) 1.22 to 1.66) as well as with opioids compared to a non-opioid active pharmacological comparator, with a similar risk ratio (RR 1.21, 95% CI 1.10 to 1.33). There was also a significantly increased risk of experiencing a serious adverse event with opioids compared to placebo (RR 2.75, 95% CI 2.06 to 3.67). Furthermore, we found significantly increased risk ratios with opioids compared to placebo for a number of specific adverse events: constipation, dizziness, drowsiness, fatigue, hot flushes, increased sweating, nausea, pruritus, and vomiting.There was no data on any of the following prespecified adverse events of interest in any of the included reviews in this overview of Cochrane Reviews: addiction, cognitive dysfunction, depressive symptoms or mood disturbances, hypogonadism or other endocrine dysfunction, respiratory depression, sexual dysfunction, and sleep apnoea or sleep-disordered breathing. We found no data for adverse events analysed by sex or ethnicity.
AUTHORS' CONCLUSIONS
A number of adverse events, including serious adverse events, are associated with the medium- and long-term use of opioids for CNCP. The absolute event rate for any adverse event with opioids in trials using a placebo as comparison was 78%, with an absolute event rate of 7.5% for any serious adverse event. Based on the adverse events identified, clinically relevant benefit would need to be clearly demonstrated before long-term use could be considered in people with CNCP in clinical practice. A number of adverse events that we would have expected to occur with opioid use were not reported in the included Cochrane Reviews. Going forward, we recommend more rigorous identification and reporting of all adverse events in randomised controlled trials and systematic reviews on opioid therapy. The absence of data for many adverse events represents a serious limitation of the evidence on opioids. We also recommend extending study follow-up, as a latency of onset may exist for some adverse events.
Topics: Adult; Analgesics, Opioid; Chronic Pain; Humans; Patient Dropouts; Randomized Controlled Trials as Topic; Review Literature as Topic; Time Factors
PubMed: 29084357
DOI: 10.1002/14651858.CD012509.pub2 -
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 -
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 -
Vaccines Apr 2022The Vaccine Adverse Event Reporting System database has been used to report adverse events following several vaccines. We studied the patient population predisposed to... (Review)
Review
The Vaccine Adverse Event Reporting System database has been used to report adverse events following several vaccines. We studied the patient population predisposed to such reactions and how these reactions differ with respect to the vaccine type. We searched the electronic databases PubMed, EMBASE, and Scopus up to 9 July 2021 for any study describing cardiac adverse events attributed to the vaccination. A total of 56 studies met the criteria comprising 340 patients. There were 20 studies describing cardiac adverse events following smallpox vaccination, 11 studies describing adverse events after influenza vaccination, and 18 studies describing adverse events after COVID-19 vaccination. There was a total of six studies describing cardiac adverse events after the pneumococcal vaccine, tetanus toxoid, cholera vaccine, and rabies vaccine. Adverse events following influenza vaccination occurred more commonly in older females within an average duration of four days from vaccination. Pericardial involvement was the most reported adverse event. Adverse events following COVID-19 vaccination happened at a mean age of 42.7 years, more commonly in males, and mostly after a second dose. Adverse events following smallpox vaccination occurred more commonly in younger males, with an average onset of symptoms from vaccination around 16.6 days. Adverse events were mostly myopericarditis; however, the acute coronary syndrome has been reported with some vaccines.
PubMed: 35632455
DOI: 10.3390/vaccines10050700 -
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 -
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 -
Medical Science Monitor : International... Nov 2021Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant...
Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant national reporting agencies as part of the process of post-marketing drug safety monitoring. In the US, the Vaccine Adverse Event Reporting System (VAERS) is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Data from VAERS and other national and global reporting systems show very low rates of adverse events related to currently approved SARS-CoV-2 vaccines. Populations studies have supported the findings from adverse event reporting systems. The presentation, monitoring, and reporting of adverse events related to SARS-CoV-2 vaccines may have future applications in vaccine monitoring for several other potential pandemic zoonotic infections. This editorial aims to summarize the current understanding of adverse events from current COVID-19 vaccines from global adverse event reporting systems, rather than individual case reports or anecdotal reporting in the media.
Topics: Adverse Drug Reaction Reporting Systems; COVID-19; COVID-19 Vaccines; Humans; International Agencies; SARS-CoV-2; Vaccination; COVID-19 Drug Treatment
PubMed: 34719663
DOI: 10.12659/MSM.935299