Journal of Patient Safety最新文献

Background: Simulation-based education is an essential tool in modern health care, enhancing technical, behavioral, and decision-making skills while improving patient safety and clinical outcomes. In Italy, health care simulation has developed over the past 2 decades, with multiple scientific societies and educational initiatives promoting its use. However, the absence of national data and standardized educational frameworks presents a barrier to its widespread adoption. Recognizing these challenges, the Italian Ministry of Health convened a panel of experts to establish a strategic framework for simulation in health care, aiming to standardize methodologies, promote quality assurance, and foster collaboration across institutions.

Methods: The panel, composed of experts in health care simulation, clinical practice, and risk management, conducted a series of telematic meetings from April 2022 to July 2022. A consensus-driven approach was adopted to review existing literature, identify key areas for development, and formulate practical recommendations.

Results: Key recommendations include: establishing a national registry of simulation programs, defining accreditation criteria for simulation-based education, standardizing professional competencies for simulation educators, integrating simulation into health care curricula and continuous professional development, developing national standards for simulation-based training in new technologies and clinical procedures, utilizing simulation in public health preparedness and emergency response planning, promoting research funding and inter-institutional collaborations.

Conclusion: This position paper provides a strategic roadmap for standardizing simulation-based education across the Italian health care system. By establishing national standards and fostering collaboration, simulation can significantly improve patient safety, care quality, and health care system resilience.

Background: Medication-related inappropriateness (MRI) poses a significant risk to elderly patients, particularly in aged care settings, where complex medication regimens and health care challenges increase the likelihood of errors. Addressing MRI is critical to enhancing patient safety and improving health outcomes for older adults. This study aims to evaluate the effectiveness of interventions designed to reduce MRI and improve prescribing practices in elderly populations through a systematic review and meta-analysis.

Methods: A systematic review and meta-analysis were conducted following the Cochrane Handbook for Systematic Reviews of Interventions. Databases including MEDLINE, EMBASE, CINAHL, PubMed, and EBSCOhost were searched from April 2020 to November 2023. Randomized controlled trials (RCTs) and nonrandomized controlled studies evaluating interventions for reducing MRI in elderly patients receiving care in various healthcare settings were included. Eight studies involving a total of 33,170 participants across 7 countries qualified for analysis. The pooled odds ratio (OR) with a 95% CI was calculated to measure intervention effectiveness. Statistical heterogeneity was assessed using the Higgins I ² statistic, and a random-effects model was applied to account for variability.

Results: Interventions ranged from educational programs and peer reviews to computerised decision-support systems. The meta-analysis demonstrated a significant reduction in MRI, with a pooled OR of 0.43 (95% CI: 0.31-0.60), indicating a 57% reduction in inappropriate prescribing. Educational interventions were particularly effective, fostering improved prescriber behavior and medication safety. However, high heterogeneity ( I ²=92%) underscored variations in patient demographics, care settings, and intervention designs.

Conclusions: Educational interventions and decision-support systems are found to significantly reduce the inappropriate prescribing of medication in older patients. More research is required to address variability, determine long-term outcomes, and facilitate broader implementation to improve medication safety.

Objective: With limited evidence to date about the application of Statutory Duty of Candour, we sought to synthesize evidence of the application of this legislation in health service organisations and determine its impacts on patients, families and staff.

Methods: A search strategy was developed and applied to 6 electronic databases, along with relevant websites, to identify evidence in published and gray literature. Eligible articles were published from 2010 onwards, reported primary or secondary analysis of data of the application of the Statutory Duty of Candour in relation to patient safety events in countries that have enacted the Duty. Two reviewers independently extracted data and assessed the risk of bias. Narrative synthesis was conducted using the Synthesis Without Meta-Analysis (SWiM) guideline. The certainty of evidence was rated by the Grading of Recommendations Assessment and Evaluation (GRADE) approach.

Results: Included articles (n=15) originated from the United Kingdom (n=14) and Ireland (n=1); 9 were retrieved from the electronic and 6 from the gray literature search. Findings predominantly focused on the implementation of duty of candour, including understanding requirements and thresholds for use (12 articles), with limited evidence of staff (2 articles), health service (2 articles), and particularly patient and carer outcomes (1 article).

Conclusions: Limited evidence is available about the use and impacts of the duty of candour despite 10 years passing since its initial implementation in the United Kingdom. Few peer-reviewed studies have captured primary evaluative data, none of the scale and breadth in terms of health care providers required to draw conclusions about the use or effectiveness of the duty of candour for achieving open and honest communication about health care incidents.

Objectives: Electronic health records (EHR)-based triggers (eTriggers) have been used to study diagnostic errors in the emergency department (ED), often with suboptimal performance. Our objective was to investigate incremental value of multi-factor machine learning (ML) approaches to improve eTrigger performance.

Methods: Patients presenting to an academic ED were categorized into trigger-positive and trigger-negative using standard trigger (T) definitions: (T1) ED return visits resulting in admission within 10 days; (T2) care escalation from the inpatient unit to the ICU within 24 hours; and (T3) deaths within 24 hours of admission. We trained and evaluated 6 supervised ML models.

Results: A total of 124,053 consecutive encounters (5791 T-positive and 118,262 T-negative) were included. Among the T-positive, 4159 (72%) were associated with T1, 1415 (24%) with T2, and 217 (4%) with T3. The T-based positive predictive values (PPV) were 5.2% for T1, 8.2% for T2, and 6.5% for T3. ML models trained and evaluated on balanced training dataset and imbalanced test set had low classification performances (accuracy: 0.72-0.95; PPV: 0.00-0.16; F1-score: 0.00-0.23). Higher performances were observed in balanced test sets (accuracy: 0.80-0.97; PPV: 0.82-1.00; F1-score: 0.79-0.97). Comparing models trained on clinically annotated data with models trained on T-based labels identified other important factors.

Conclusions: Utilizing machine learning to refine e-triggers slightly improves the identification of diagnostic errors, as evidenced by an increase in PPV values. We identified new potential factors contributing to ED diagnostic errors. These findings open new avenues to construct or modify more accurate e-triggers for diagnostic error identification.

Objective: The study aims to analyse the composition of patients registered on the waiting list for kidney transplantation with end-stage renal disease (ESRD) in the Republic of Kazakhstan and to assess the dynamics of transplants performed from 2012 to 2023.

Methods: The study was based on data from the Republican Centre for Coordination of Transplantation and High-Tech Medical Services of the Ministry of Health of the Republic of Kazakhstan. The study addressed the distribution of patients by organ, age group, gender and geographic location. The length of the waiting time for transplantation was also analyzed. In total, 3971 patients concluded the registry, of whom 91.2% (3624 people) were waiting for a kidney transplant. The largest number of recipients was registered in the cities of Almaty (17.6%), Astana (11.2%), and the Aktobe region (8.8%).

Results: The results demonstrated that most patients (52.7%) were waiting for transplantation for 1 to 5 years, 39.1% were waiting for 5 to 9 years, and about 8% of patients were waiting for more than 10 years. The average age of the patients ranged from 30 to 69 years, with the largest proportion being working age. The gender and age distribution showed a predominance of adults (97.4%) and men (58.7%).

Conclusions: An analysis of the transplant dynamics revealed that 1876 kidney transplants were performed during the period, of which 9.7% (182) were performed based on posthumous donation and 90.2% (1,694) were from related donors. This highlights the problem of the low level of posthumous donation in Kazakhstan. The findings indicate the need to increase the level of posthumous donation and optimise the recipient-matching process to reduce waiting times and improve patient survival. It is worth intensifying the monitoring of patients on the waiting list to identify contraindications promptly and prevent complications, which will increase the efficiency of the transplant service in the country.

Objective: Our aim was to assess patients' availability for, and interest in, integrative holistic health offerings during a hospitalization. Although health care systems are increasingly providing holistic services in outpatient settings, limited research exists concerning expansion to inpatient settings.

Methods: In this exploratory qualitative assessment using a 5-phased systems-engineering approach to improve the well-being of hospitalized patients and their clinicians, we deployed a modified engineering concept ("customer journey") to collect information on how patients interact with the hospital environment and their clinicians. These journeys included observing patients throughout their hospitalization and conducting semi-structured telephone interviews after discharge. Observational data, captured via field notes, was used to calculate the percentage of time various interactions occurred during a patient's hospital stay (eg, eating, idle, sleeping, clinical encounters) making them potentially available or unavailable for additional holistic or whole health offerings. Interviews, conducted to understand patient views on these offerings, were recorded, transcribed, and analyzed using content analysis.

Results: Eleven patients from 2 Midwestern hospitals were observed for a total of 115 hours. Observations revealed that patients have substantial idle time during hospital stays, especially in the late afternoon between 3:00 and 5:00 pm . Follow-up interviews with 7 of these patients showed that patients have an interest in holistic health offerings (eg, massage therapy, aromatherapy, and music options) and believe that they could benefit from these services.

Conclusions: Our study revealed that patients have the time, the interest, and the belief that they may benefit from whole health offerings during a hospital stay.

Background: In Japan, a significant number of ventilator-related medical accidents continue to be reported, with causes frequently linked to both equipment malfunctions and human errors. Conventional analytical methods often lack the methodological rigor needed for comprehensive safety analysis.

Objectives: This study explores the application of System-Theoretic Process Analysis (STPA) as a novel approach to ventilator safety analysis. The goal is to identify potential hazards arising from human errors and device failures and to establish system-level safety constraints.

Methods: STPA is employed to construct a control structure diagram of a ventilator system, offering a system-wide perspective to identify Unsafe Control Actions (UCAs) and resulting hazardous scenarios. This approach provides a structured analysis of system interactions to derive safety constraints aimed at reducing risks.

Results: STPA successfully identified UCAs and system-level interactions that could lead to hazardous outcomes. Compared with the Critical Incident Report (CIR) by the Japan Council for Quality Health Care (JCQHC), which provides retrospective insights into ventilator-related incidents, STPA demonstrates a systematic and comprehensive methodology. It analyzed the mechanisms by which incidents could arise within the system, considering both human and technical factors. The analysis identified hazardous interactions and provided a foundation for implementing preventive measures.

Conclusions: STPA offers a holistic framework for ventilator safety, surpassing traditional analysis methods by addressing complex human-technical interactions. The results contribute to enhanced ventilator safety, improved risk management, and a stronger safety culture across medical devices.

Objectives: Some patients cannot return home after hospitalization due to temporary or permanent disabilities, leading to so-called "complex discharge." This study aims to investigate the consequences and financial implications of complex discharge, and to assess a low-cost reorganization that removed a control point in the discharge process.

Materials and methods: A retrospective observational study analyzed 21,448 hospital discharge records (HDRs) for 2019, and 18,584 HDRs for 2021, of the Molinette Hospital, the third largest Italian hospital. Factors influencing length of stay (LOS) were analyzed using linear regression models. The economic impact of complex discharge was simulated by assuming its absence, calculating the gain in production expected if hospital beds were used for noncomplex patients. To assess reorganization's impact, LOS was compared before and after its implementation using linear regression and interrupted time series (ITT) models.

Results: Factors associated with increased LOS included age, emergency admission, transfers to another hospital, and expected LOS based on diagnosis-related group. Complex discharge patients had a 50.2% longer LOS ( P < 0.001, adjusted R2 of 36.47%). Simulating absence of these patients provided an expected gain in production equal to 4,522,879.93€. The reorganization reduced LOS by 6.1 days for the 72 affected patients. The ITT analysis showed that the intervention flattened the preexisting LOS upward trend ( P < 0.001, adjusted R2 of 33.21%).

Conclusions: Complex discharge significantly increases LOS, with an important economic impact. The reorganization was a low-cost intervention that significantly modified the discharge dynamics, demonstrating its potential for improving patient outcomes and reducing health care costs.

Transformational leadership plays a major role in enhancing organizational culture and service outcomes within the health care sector. Recent reports from various health care systems worldwide have highlighted systemic issues such as blame culture and inadequate leadership training in health services. Although this paper references UK-specific reports, the discussion is applicable to health care leadership challenges on a global scale, as similar issues have been documented in other countries, including the United States, Canada, Australia, and Germany. There should be a shift from a hierarchical (vertical) to a more collaborative (horizontal) structure of leadership. This will result in intellectual stimulation, idealized influence, inspirational motivation, and individualized consideration. Health care staff should be empowered through transformative leadership to improve interdisciplinary collaboration, service provision, and foster a more supportive culture internationally, especially in the post-COVID era, where global health care systems face workforce burnout and leadership crises. While acknowledging limitations, including potential over-reliance on leaders' personalities and ethical risks, the paper advocates for leadership development as a vital tool in addressing the current challenges facing health care systems globally. Transformational leadership is positioned as a powerful catalyst for cultural change and improved health care outcomes.

Objective: Efficient execution of medication management strategies, such as medication reviews, is crucial for reducing potential medication-related harms and improving treatment effectiveness. We assessed the perspectives of primary care professionals on how the rapid integration of telehealth during the COVID-19 pandemic affected medication management in primary care.

Methods: Semistructured interviews were conducted with 27 family medicine clinicians, support staff, and administrators. Interview questions focused on primary care processes, care delivery, and the use of telehealth technology during the pandemic. Codes were initially developed a priori using the interview guide and iteratively revised based on data and consensus meetings. The final coding structure was then used to analyze all transcripts.

Results: Participants were predominantly physicians (65.4%) who practiced family medicine (89.5%). Primary care professionals indicated that the swift integration of telehealth significantly affected the medication review and reconciliation procedures established within their practices, sometimes causing potential risks to medication safety, while others observed no significant changes in this process. Among the notable changes were the increased workload on providers and a reduced role of the collaborative team-based approach. Overall, providers recognized both the benefits and challenges of using telehealth for medication management.

Conclusions: The rapid adoption of telehealth during the pandemic influenced medication management strategies, posing challenges to patient safety through changes in medication reconciliation processes and lack of team-based approaches to medication management. Ensuring patient safety in primary care settings through telehealth services requires the strategic integration of evidence-based medication safety processes in telehealth service delivery designs.