The association between doctors\' long working hours and the seriousness of adverse events with high patient impact has not been fully confirmed. Most previous studies were based on work hour regulations using more than 80 hours per week as an indicator of long working hours. We aimed to assess the association using a shorter indicator as the cut-off for long working hours among hospital doctors including senior doctors. This cross-sectional study used 12,245 adverse event reports from the Japan Council for Quality Health Care. We defined long working hours as 55 hours or more in the week before the adverse event and assessed the association with the seriousness of adverse events with high patient impact. The results showed that doctors working 55 or more hours in the preceding week were more likely to be involved in serious adverse events than those working fewer hours (odds ratio (OR) 1.22, 95% confidence interval (CI): 1.12-1.32). This association remained significant after adjusting for all covariates (OR 1.18, 95% CI: 1.08-1.28). Senior doctors were more likely to be involved in serious adverse events. Long working hours among doctors were associated with the seriousness of adverse events.

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UNASSIGNED: This article aims to examine the impact of nursing workforce skill-mix (percentage of critical care registered nurses [CCRN]) in the intensive care unit (ICU) during a patient\'s stay.
UNASSIGNED: Registry linked cohort study of the Australian and New Zealand Intensive Care Society Adult Patient Database and the Critical Health Resources Information System using real-time nursing workforce data.
UNASSIGNED: Fifteen public and 5 private hospital ICUs in Victoria, Australia.
UNASSIGNED: There were 16,618 adult patients admitted between 1 December 2021 and 30 September 2022.
UNASSIGNED: Primary outcome: in-hospital mortality. Secondary outcomes: in-ICU mortality, development of delirium, pressure injury, duration of stay in-ICU and hospital, after-hours discharge from ICU and readmission to ICU.
UNASSIGNED: In total, 6563 (39.5%) patients were cared for in ICUs with >75% CCRN, 7695 (46.3%) in ICUs with 50-75% CCRN, and 2360 (14.2%) in ICUs with <50% CCRN. In-hospital mortality was 534 (8.1%) vs. 859 (11.2%) vs. 252 (10.7%) respectively. After adjusting for confounders, patients cared for in ICUs with 50-75% CCRN (adjusted OR 1.21 [95% CI 1.02-1.45]) were more likely to die compared to patients in ICUs with >75% CCRN. A similar but non-significant trend was seen in ICUs with <50% CCRN (adjusted OR 1.21 [95% CI 0.94-1.55]), when compared to patients in ICUs with >75% CCRN. In-ICU mortality, delirium, pressure injuries, after-hours discharge and ICU length of stay were lower in ICUs with CCRN>75%.
UNASSIGNED: The nursing skill-mix in ICU impacts outcomes and should be routinely monitored. Health system regulators, hospital administrators and ICU leaders should ensure nursing workforce planning and education align with these findings to maximise patient outcomes.

BACKGROUND: At least 10% of hospital admissions in high-income countries, including Australia, are associated with patient safety incidents, which contribute to patient harm (\'adverse events\'). When a patient is seriously harmed, an investigation or review is undertaken to reduce the risk of further incidents occurring. Despite 20 years of investigations into adverse events in healthcare, few evaluations provide evidence of their quality and effectiveness in reducing preventable harm.This study aims to develop consistent, informed and robust best practice guidance, at state and national levels, that will improve the response, learning and health system improvements arising from adverse events.
METHODS: The setting will be healthcare organisations in Australian public health systems in the states of New South Wales, Queensland, Victoria and the Australian Capital Territory. We will apply a multistage mixed-methods research design with evaluation and in-situ feasibility testing. This will include literature reviews (stage 1), an assessment of the quality of 300 adverse event investigation reports from participating hospitals (stage 2), and a policy/procedure document review from participating hospitals (stage 3) as well as focus groups and interviews on perspectives and experiences of investigations with healthcare staff and consumers (stage 4). After triangulating results from stages 1-4, we will then codesign tools and guidance for the conduct of investigations with staff and consumers (stage 5) and conduct feasibility testing on the guidance (stage 6). Participants will include healthcare safety systems policymakers and staff (n=120-255) who commission, undertake or review investigations and consumers (n=20-32) who have been impacted by adverse events.
BACKGROUND: Ethics approval has been granted by the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH02007 and 2023/ETH02341).The research findings will be incorporated into best practice guidance, published in international and national journals and disseminated through conferences.

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).

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Safe delivery of care is a priority in dentistry, while basic epidemiological knowledge of patient safety incidents is still lacking. The objectives of this study were to (1) classify patient safety incidents related to primary dental care in Denmark in the period 2016-2020 and study the distribution of different types of dental treatment categories where harm occurred, (2) clarify treatment categories leading to \"nerve injury\" and \"tooth loss\" and (3) assess the financial cost of patient-harm claims. Data from the Danish Dental Compensation Act (DDCA) database was retrieved from all filed cases from 1st January 2016 until 31st December 2020 pertaining to: (1) The reason why the patient applied for treatment-related harm compensation, (2) the event that led to the alleged harm (treatment category), (3) the type of patient-harm, and (4) the financial cost of all harm compensations. A total of 9069 claims were retrieved, of which 5079 (56%) were found eligible for compensation. The three most frequent categories leading to compensation were \"Root canal treatment and post preparation\"(n = 2461, 48% of all approved claims), \"lack of timely diagnosis and initiation of treatment\" (n = 905, 18%) and \"surgery\" (n = 878, 17%). Damage to the root of the tooth accounted for more than half of all approved claims (54.36%), which was most frequently a result of either parietal perforation during endodontic treatment (18.54%) or instrument fracture (18.89%). Nerve injury accounted for 16.81% of the approved claims. Total cost of all compensation payments was €16,309,310, 41.1% of which was related to surgery (€6,707,430) and 20.4% (€3,322,927) to endodontic treatment. This comprehensive analysis documents that harm permeates all aspects of dentistry, especially in endodontics and surgery. Neglect or diagnostic delays contribute to 18% of claims, indicating that harm does not solely result from direct treatment. Treatment harm inflicts considerable societal costs.

BACKGROUND: The Global Patient Safety Action Plan, an initiative of the World Health Organization (WHO), draws attention to patient safety as being an issue of utmost importance in healthcare. In response, the World Federation of Chiropractic (WFC) has established a Global Patient Safety Task Force to advance a patient safety culture across all facets of the chiropractic profession. This commentary aims to introduce principles and call upon the chiropractic profession to actively engage with the Global Patient Safety Action Plan beginning immediately and over the coming decade.
METHODS: This commentary addresses why the chiropractic profession should pay attention to the WHO Global Patient Safety Action Plan, and what actions the chiropractic profession should take to advance these objectives. Each strategic objective identified by WHO serves as a focal point for reflection and action. Objective 1 emphasizes the need to view each clinical interaction as a chance to improve patient safety through learning. Objective 2 urges the implementation of frameworks that dismantle systemic obstacles, minimizing human errors and strengthening patient safety procedures. Objective 3 supports the optimization of clinical process safety. Objective 4 recognizes the need for patient and family engagement. Objective 5 describes the need for integrated patient safety competencies in training programs. Objective 6 explains the need for foundational data infrastructure, ecosystem, and culture. Objective 7 emphasizes that patient safety is optimized when healthcare professionals cultivate synergy and partnerships.
CONCLUSIONS: The WFC Global Patient Safety Task Force provides a structured framework for aligning essential considerations for patient safety in chiropractic care with WHO strategic objectives. Embracing the prescribed action steps offers a roadmap for the chiropractic profession to nurture an inclusive and dedicated culture, placing patient safety at its core. This commentary advocates for a concerted effort within the chiropractic community to commit to and implement these principles for the collective advancement of patient safety.