OBJECTIVE: Billions of vascular access devices (VADs) are inserted annually for intravenous therapy worldwide. However, their use is not without challenges. Facilitating the process and enhancing results, hospital authorities have created vascular access specialist teams (VASTs) with advanced competencies in the evaluation, insertion, care and management of VADs. The objective is to compare the effectiveness of VASTs versus standard practice regarding cannulation success and vascular access maintenance in hospitalised adults.
METHODS: Systematic review, using the Mixed Methods Appraisal Tool.
METHODS: We conducted a structured data search on Cochrane Library, MEDLINE, Web of Science, Scopus and EBSCOhost up to 31 May 2023. We did not impose a time limit regarding the date of publication.
METHODS: Studies were eligible for inclusion in the review if they were randomised and non-randomised trials and observational studies.
METHODS: We included studies that described or evaluated the activity of VASTs compared with clinical practitioners. The outcomes analysed were the success of the cannulation and the incidence of associated adverse effects.
RESULTS: The search strategy produced 3053 papers published between 1984 and 2020, from which 12 were selected for analysis. VASTs are heterogeneously described among these studies, which mainly focus on insertions, frequently for patients with difficult intravenous access. Some patients presented with specific needs or requirement for specific insertion technique or catheter type. Compared with usual practice, these studies indicate that the involvement of a VAST is associated with a higher effectiveness in terms of first attempt insertions and insertion success rates, and a reduction in catheter-associated adverse events. However, meta-analyses confirming this trend are not currently possible.
CONCLUSIONS: It seems apparent that VASTS contribute to improving the health of patients during the administration of intravenous. VASTs seem to increase the effectiveness of VAD insertion and care and reduce complications.
UNASSIGNED: CRD42021231259.

UNASSIGNED: Healthcare systems should ensure the provision of quality services to patients without harming them. However, the provision of services is occasionally accompanied by harm or complications, most of which are preventable. Most studies have focused on secondary healthcare rather than primary healthcare (PHC). Thus, this study aimed to identify various dimensions and components of patient safety in PHC worldwide.
UNASSIGNED: This systematic review study was conducted in November 2022 based on PRISMA reporting guidelines. Studies were retrieved from PubMed, Scopus, Cochrane Library, Web of Science, and EMBASE and searched for English documents using the keywords \"patient safety\" and \"PHC\" from 2000 to 2022. Finally, two reviewers extracted the data independently and analyzed using thematic content analysis.
UNASSIGNED: Overall, 23 out of the initially 4937 identified articles were selected for the final analysis based on the inclusion and exclusion criteria. Most of these studies used a qualitative-quantitative approach (61.9%, seven studies for both), and 64% had been conducted in European countries. Eventually, five dimensions and 22 components were identified for patient safety in PHC, including management measures, quality management, resources and technology, documents, and patient-related factors.
UNASSIGNED: The patient safety dimensions and components identified in this research can help develop a clear definition of patient safety and its assessment standards and criteria in PHC. Considering that most previous studies on patient safety in PHC were conducted in European and developed countries, it is suggested that researchers conduct more studies in developing countries to fill this research gap.

UNASSIGNED: To analyze and summarize the types, incidence rates and relevant influencing factors of adverse events (AEs) after high-intensity focused ultrasound ablation of gynecological diseases and provide reference and basis for handling such events in clinical practice.
UNASSIGNED: We searched PubMed, Cochrane Library, Web of Science and Embase databases to retrieve all literature since its establishment until February 2024. We evaluated the quality of included literature and publication bias and conducted a meta-analysis of single group rates for various AEs using Stata 17.0.
UNASSIGNED: This systematic review finally included 41 articles. We summarized 34 kinds of AEs in 7 aspects and conducted a single group rate meta-analysis and sub-group analysis of 16 kinds of AEs. Among the common AEs of High-Intensity Focused Ultrasound (HIFU), the incidence of lower abdominal pain/pelvic pain is 36.1% (95% CI: 24.3%∼48.8%), vaginal bleeding is 20.6% (95% CI: 13.9%∼28.0%), vaginal discharge is 14.0% (95% CI: 9.6%∼19.1%), myoma discharge is 24% (95% CI: 14.6%∼34.8%), buttock pain is 10.8% (95% CI: 6.0%∼16.5%) and sacral pain is 10% (95% CI: 8.8%∼11.2%). Serious complications include uterine rupture, necrotic tissue obstruction requiring surgical intervention, third degree skin burns and persistent lower limb pain or movement disorders.
UNASSIGNED: The common AEs after HIFU surgery are mostly mild and controllable, and the incidence of serious complications is extremely low. By reasonable prevention and active intervention, these events can be further reduced, making it a safe and effective treatment method. It is a good choice for patients who crave noninvasive treatment or have other surgical contraindications.

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.
OBJECTIVE: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.
METHODS: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.
RESULTS: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.
CONCLUSIONS: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.
BACKGROUND: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747.
UNASSIGNED: PRR1-10.2196/51614.

BACKGROUND: Magnetic resonance imaging (MRI) is a rapidly evolving modality, generally considered safe due to lack of ionising radiation. While MRI technology and techniques are improving, many of the safety concerns remain the same as when first established. Patient thermal injuries are the most frequently reported adverse event, accounting for 59% of MRI incidents to the Food and Drug Administration (FDA). Surveys indicate many incidents remain unreported. Patient thermal injuries are preventable and various methods for their mitigation have been published. However, recommendations can be variable, fragmented and confusing. The aim of this systematic review was to synthesise the evidence on MRI safety and associated skin injuries and offer comprehensive recommendations for radiographers to prevent skin thermal injuries.
METHODS: Four journal databases were searched for sources published January 2010-May 2023, presenting information on MRI safety and thermal injuries.
RESULTS: Of 26,801 articles returned, after careful screening and based on the eligibility criteria, only 79 articles and an additional 19 grey literature sources were included (n = 98). Included studies were examined using thematic analysis to determine if holistic recommendations can be provided to assist in preventing skin burns. This resulted in three simplified recommendations: Remove any electrically conductive items Insulate the patient to prevent any conductive loops or contact with objects Communicate regularly CONCLUSION: By implementing the above recommendations, it is estimated that 97% of skin burns could be prevented. With thermal injuries continuing to impact MRI safety, strategies to prevent skin burns and heating are essential. Assessing individual risks, rather than blanket policies, will help prevent skin thermal injuries occurring, improving patient care.

Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical in a climate of vaccine hesitancy, where public trust is paramount. Pharmacovigilance strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection of AEFIs during clinical trials is crucial for thorough safety analysis and preventing serious reactions once vaccines are deployed. This review highlights the importance of societal reporting, encompassing contributions from community members, healthcare workers, and pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI reporting. While vaccines are demonstrably safe, the possibility of adverse events necessitates continuous post-marketing surveillance. However, underreporting remains a challenge, underscoring the critical role of public engagement in pharmacovigilance. This narrative review comprehensively examines and synthesizes key aspects of virus vaccine pharmacovigilance, with special considerations for specific population groups. We explore applicable legislation, the spectrum of AEFIs associated with major vaccines, and the unique challenges and perspectives surrounding pharmacovigilance in this domain.

OBJECTIVE: This meta-analysis aims to evaluate the safety and efficacy of restarting immune checkpoint inhibitors (ICIs) in patients with non-small cell lung cancer (NSCLC) after experiencing immune-related adverse events (irAEs).
METHODS: A comprehensive search of PubMed, Web of Science, Embase, and the Cochrane Library was conducted to identify studies investigating the safety and efficacy of restarting ICIs in NSCLC patients after irAEs. Outcome measures, including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) after ICI restarting, were extracted. Meta-analysis was performed using the R meta-package.
RESULTS: Four studies involving a total of 326 subjects were included, comprising 137 patients who restarted ICI treatment after irAEs and 189 patients who did not restart ICI treatment. The results revealed that ICI restarting was associated with an increased ORR (OR = 2.36, 95% CI 1.49-3.84), prolonged PFS (HR = 0.60, 95% CI 0.42-0.86), and prolonged OS (HR = 0.65, 95% CI 0.43-0.99) compared to non-restarting. The incidence of irAEs after ICI restarting was 45% (95% CI 0.27-0.63).
CONCLUSIONS: Restarting ICI treatment after discontinuation due to previous irAEs appears to be a reasonable option for NSCLC patients. However, a comprehensive assessment of the potential benefits and risks to individual patients is crucial, and close monitoring of irAEs is warranted.

Seizures are a concerning adverse event frequently associated with the use of psychedelics, and hence, studies involving these substances tend to exclude patients with past history of epilepsy. This is especially relevant because epileptic seizures are markedly increased in the population suffering from mental disorders, and psychedelic assisted therapy is being researched as a promising treatment for several of them. To determine the extent of the current literature on the relationship between classic psychedelics and seizures, a scoping review was performed using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). The search was conducted in PubMed, Web of Science, Google scholar, LILACS and Scielo, and both animal and human models were included. A total of 16 publications on humans, and 11 on animals, were found. The results are heterogeneous, but globally suggest that psychedelics may not increase the risk of seizures in healthy individuals or animals in the absence of other drugs. However, concomitant use of other substances or drugs, such as kambo or lithium, could increase the risk of seizures. Additionally, these conclusions are drawn from data lacking sufficient external validity, so they should be interpreted with caution. Future paths for research and a summary on possible neurobiological underpinnings that might clarify the relationship between classical psychedelics and seizures are also provided.

BACKGROUND: Topical corticosteroids are widely used as a treatment for itch and wheals (urticaria), but their benefits and harms are unclear.
OBJECTIVE: To systematically synthesize the benefits and harms of topical corticosteroids for the treatment of urticaria.
METHODS: We searched MEDLINE, EMBASE, and CENTRAL from database inception to March 23, 2024, for randomized trials addressing comparing topical corticosteroid to placebo for patients with urticaria (either chronic spontaneous or inducible urticaria or acute urticaria elicited from skin/intradermal allergy testing). Paired reviewers independently screened records, extracted data, and assessed risk of bias. Random-effects meta-analyses addressed urticaria severity, itch severity (numeric rating scale; range 0-10; higher is worse), and adverse events. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach informed certainty of evidence ratings. PROSPERO registration: CRD42023455182.
RESULTS: Nineteen RCTs enrolled 379 participants with a median of mean age of 30.1 years (range 21.1 to 44.0). Compared to placebo, topical corticosteroids may reduce wheal size (ratio of means 0.47, 95%CI 0.38 to 0.59; low certainty) and itch severity (mean difference -1.30, 95%CI -5.07 to 2.46; very low certainty). Topical corticosteroids result in little to no difference in overall adverse events (94 fewer patients per 1000, 95%CrI 172 fewer to 12 more; high certainty).
CONCLUSIONS: Compared to placebo, topical corticosteroids may result in a reduction of wheal size, and result in little to no difference in overall adverse events. Topical corticosteroids may reduce itch severity, but the evidence is very uncertain. Future large, randomized trials addressing the use of topical corticosteroids would further support optimal urticaria management.

BACKGROUND: Knowledge about patient safety in orthodontics is scarce. Lack of standardisation and a common terminology hinders research and limits our understanding of the discipline. This study aims to 1) summarise current knowledge about patient safety incidents (PSI) in orthodontic care by conducting a systematic literature search, 2) propose a new standardisation of PSI terminology and 3) propose a future research agenda on patient safety in the field of orthodontics.
METHODS: A systematic literature search was performed in the main online sources of PubMed, Web of Science, Scopus and OpenGrey from their inception to 1 July 2023. Inclusion criteria were based on the World Health Organization´s (WHO) research cycle on patient safety. Studies providing information about the cycle\'s steps related to orthodontics were included. Study selection and data extraction were performed by two of the authors.
RESULTS: A total of 3,923 articles were retrieved. After review of titles and abstracts, 41 articles were selected for full-text review and 25 articles were eligible for inclusion. Seven provided information on the WHO\'s research cycle step 1 (\"measuring harm\"), twenty-one on \"understanding causes\" (step 2) and twelve on \"identifying solutions\" (step 3). No study provided information on Steps 4 and 5 (\"evaluating impact\" or \"translating evidence into safer care\").
CONCLUSIONS: Current evidence on patient safety in orthodontics is scarce due to a lack of standardised reporting and probably also under-reporting of PSIs. Current literature on orthodontic patient safety deals primarily with \"measuring harms\" and \"understanding causes of patient safety\", whereas less attention has been devoted to initiatives \"identifying solutions\", \"evaluating impact\" and \"translating evidence into safer care\". The present project holds a proposal for a new categorisation, terminology and future research agenda that may serve as a framework to support future research and clinical initiatives to improve patient safety in orthodontic care.
BACKGROUND: PROSPERO (CRD42022371982).