Adverse events associated with failed airway management may have catastrophic consequences, and despite many advances in knowledge, guidelines and equipment, airway incidents and patient harm continue to occur. Patient safety incident reporting systems have been established to facilitate a reduction in incidents. However, it has been found that corrective actions are inadequate and successful safety improvements scarce. The aim of this scoping review was to assess whether the same is true for airway incidents by exploring academic literature that describes system changes in airway management in high-income countries over the last 30 years, based on findings and recommendations from incident reports and closed claims studies. This review followed the most recent guidance from the Joanna Briggs Institute (JBI). PubMed, Ovid MEDLINE and Embase, the JBI database, SCOPUS, the Cochrane Library and websites for anaesthetic societies were searched for eligible articles. Included articles were analysed and data synthesised to address the review\'s aim. The initial search yielded 28,492 results, of which 111 articles proceeded to the analysis phase. These included 23 full-text articles, 78 conference abstracts and 10 national guidelines addressing a range of airway initiatives across anaesthesia, intensive care and emergency medicine. While findings and recommendations from airway incident analyses are commonly published, there is a gap in the literature regarding the resulting system changes to reduce the number and severity of adverse airway events. Airway safety management mainly focuses on Safety-I events and thereby does not consider Safety-II principles, potentially missing out on all the information available from situations where airway management went well.

BACKGROUND: Diagnostic errors are an underappreciated cause of preventable mortality in hospitals and pose a risk for severe patient harm and increase hospital length of stay.
OBJECTIVE: This study aims to explore the potential of machine learning and natural language processing techniques in improving diagnostic safety surveillance. We conducted a rigorous evaluation of the feasibility and potential to use electronic health records clinical notes and existing case review data.
METHODS: Safety Learning System case review data from 1 large health system composed of 10 hospitals in the mid-Atlantic region of the United States from February 2016 to September 2021 were analyzed. The case review outcome included opportunities for improvement including diagnostic opportunities for improvement. To supplement case review data, electronic health record clinical notes were extracted and analyzed. A simple logistic regression model along with 3 forms of logistic regression models (ie, Least Absolute Shrinkage and Selection Operator, Ridge, and Elastic Net) with regularization functions was trained on this data to compare classification performances in classifying patients who experienced diagnostic errors during hospitalization. Further, statistical tests were conducted to find significant differences between female and male patients who experienced diagnostic errors.
RESULTS: In total, 126 (7.4%) patients (of 1704) had been identified by case reviewers as having experienced at least 1 diagnostic error. Patients who had experienced diagnostic error were grouped by sex: 59 (7.1%) of the 830 women and 67 (7.7%) of the 874 men. Among the patients who experienced a diagnostic error, female patients were older (median 72, IQR 66-80 vs median 67, IQR 57-76; P=.02), had higher rates of being admitted through general or internal medicine (69.5% vs 47.8%; P=.01), lower rates of cardiovascular-related admitted diagnosis (11.9% vs 28.4%; P=.02), and lower rates of being admitted through neurology department (2.3% vs 13.4%; P=.04). The Ridge model achieved the highest area under the receiver operating characteristic curve (0.885), specificity (0.797), positive predictive value (PPV; 0.24), and F1-score (0.369) in classifying patients who were at higher risk of diagnostic errors among hospitalized patients.
CONCLUSIONS: Our findings demonstrate that natural language processing can be a potential solution to more effectively identifying and selecting potential diagnostic error cases for review and therefore reducing the case review burden.

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: 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).

BACKGROUND: Harm arising from National Health Service (NHS) healthcare results in significant human cost for the patient, those who care for them, and the medical staff involved. Furthermore, patient harm results in substantial financial costs to the public purse. Improving how NHS providers in England respond to patient harm could reduce the number of claims for clinical negligence brought against NHS. Doing so will ensure those affected receive the justice they deserve and protect the public purse. Law and policy are key to supporting providers of NHS healthcare to respond to patient harm but are not necessarily understood and therefore can be challenging to apply to practice. Research exploring how law and policy supports this understanding is limited. The purpose of this scoping review is to address this knowledge gap and improve understanding by critically evaluating how law and policy supports providers of NHS healthcare in England to respond to patient harm.
METHODS: The review will use the methodological framework proposed by Arskey and O\'Malley, Levac et al and the Joanna Briggs Institute. Search strategies will be developed using selected key words and index terms. MEDLINE, CINAHL, and Westlaw and reference lists of relevant publications will be searched to identify relevant grey literature. Two reviewers will independently assess the extracted data against the eligibility criteria. All studies identified will be charted and the results presented as a narrative synthesis.

OBJECTIVE: This systematic review aimed to identify the effects of normal saline instillation before endotracheal suctioning on clinical outcomes in critically ill patients on a mechanical ventilator.
METHODS: This review was based on the guidelines of the National Evidence-based Healthcare Collaborating Agency in Korea and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Six electronic databases were searched for relevant literature. Other sources were also searched, including the reference lists of identified reports and previous systematic reviews. After the initial literature search, a two-step retrieval process was performed to select eligible studies. Then, data were collected using a newly developed form, and the risk of bias was assessed using the checklists of the Joanna Briggs Institute. Data were analyzed using both narrative syntheses and meta-analyses.
RESULTS: In total, 16 studies: 13 randomized controlled trials and three quasi-experimental studies, were included. From the narrative syntheses, instilling normal saline before endotracheal suctioning was associated with a decrease in oxygen saturation, prolonged time for oxygen saturation to recover to baseline, decreased arterial pH, increased secretion amount, reduced incidence of ventilator-associated pneumonia, increased heart rate, and increased systolic blood pressure. Meta-analyses showed a significant difference in heart rate at five minutes after suctioning but no significant differences in oxygen saturation at two and five minutes after suctioning and heart rate at two minutes after suctioning.
CONCLUSIONS: This systematic review indicated that instilling normal saline before performing endotracheal suctioning has more harmful effects than benefits.
CONCLUSIONS: As recommended in the current guidelines, it is necessary to refrain from routine normal saline instillation before endotracheal suctioning.

OBJECTIVE: This study aims to comprehensively assess the direct, severe harms of screening colonoscopy in the United States. Whereas other investigators have completed systematic reviews estimating the harms of all types of colonoscopy, this analysis focuses on screening colonoscopies that had adequate follow up to avoid undercounting delayed harms.
METHODS: PubMed and Embase were queried for relevant studies on screening colonoscopy harms published between January 1, 2002, and April 1, 2022.
METHODS: English-language studies of screening colonoscopy for average risk patients were included. Studies must have followed patients for adequate time post procedure, defined as 30 days after colonoscopy.
RESULTS: The primary outcome was the number of severe bleeding events and gastrointestinal (GI) perforations within 30 days of screening colonoscopy.
RESULTS: A total of 1951 studies were reviewed for inclusion; 94 were reviewed in full text. Of those reviewed in full, 6 studies, including a total of 467,139 colonoscopies, met our inclusion criteria and were included in our analysis of harms related to screening colonoscopies. The rate of severe bleeding ranged credibly from 16.4 to 36.18 per 10,000 colonoscopies; the rate of perforation ranged credibly from 7.62 to 8.50 per 10,000 colonoscopies.
CONCLUSIONS: This study is the first to estimate direct harms from screening colonoscopy, including harms that occur up to 30 days after the procedure. The risk of harm subsequent to screening colonoscopy is higher than previously reported and should be discussed with patients when engaging in shared decision making.

In-hospital prescribing errors (PEs) may result in patient harm, prolonged hospitalization and hospital (re)admission. These events are associated with pressure on healthcare services and significant healthcare costs. To develop targeted interventions to prevent or reduce in-hospital PEs, identification and understanding of facilitating and protective factors influencing in-hospital PEs in current daily practice is necessary, adopting a Safety-II perspective. The aim of this systematic review was to create an overview of all factors reported in the literature, both protective and facilitating, as influencing in-hospital PEs.
PubMed, EMBASE.com and the Cochrane Library (via Wiley) were searched, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement, for studies that identified factors influencing in-hospital PEs. Both qualitative and quantitative study designs were included.
Overall, 19 articles (6 qualitative and 13 quantitative studies) were included and 40 unique factors influencing in-hospital PEs were identified. These factors were categorized into five domains according to the Eindhoven classification (\'organization-related\', \'prescriber-related\', \'prescription-related\', \'technology-related\' and \'unclassified\') and visualized in an Ishikawa (Fishbone) diagram. Most of the identified factors (87.5%; n = 40) facilitated in-hospital PEs. The most frequently identified facilitating factor (39.6%; n = 19) was \'insufficient (drug) knowledge, prescribing skills and/or experience of prescribers\'.
The findings of this review could be used to identify points of engagement for future intervention studies and help hospitals determine how to optimize prescribing. A multifaceted intervention, targeting multiple factors might help to circumvent the complex challenge of in-hospital PEs.

Diagnostic errors are a major source of patient harm, most of which are caused by cognitive errors and biases. Despite research showing the relationship between software systems and cognitive processes, the impact of the electronic health record (EHR) on diagnostic error remains unknown.
We conducted a scoping review of the scientific literature to (1) survey the association between aspects of the EHR and diagnostic error, and (2) through a human-systems integration lens, identify the types of EHR issues and their impact on the stages of the diagnostic process.
We analyzed 11 research articles for the relationship between EHR use and diagnostic error. These articles highlight specific technical, usability, and workflow issues with the EHR that pose risks for diagnostic error at every stage of the diagnostic process.
Although technical problems such as EHR interoperability and data integrity pose critical issues for the diagnostic process, usability and workflow issues such as poor display design, and inability to track test results also hamper clinicians\' ability to track, process, and act in the diagnostic process. Current research methods have limited coverage over clinical settings, are not standardized, and rarely include measures of patient harm.
The available evidence shows that EHRs pose risks for diagnostic error throughout the diagnostic process, with most issues involving their incompatibility with providers\' cognitive processing. A structured and systematic model of collecting and reporting on these errors is needed to understand how the EHR shapes the diagnostic process and improve diagnostic accuracy.

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