Patients' perspectives on quality and patient safety failures: lessons learned from an inquiry into transvaginal mesh in Australia.

BACKGROUND: Transvaginal mesh (TVM) surgeries emerged as an innovative treatment for stress urine incontinency and/or pelvic organ prolapse in 1996. Years after rapid adoption of these surgeries into practice, they are a key example of worldwide failure of healthcare quality and patient safety. The prevalence of TVM-associated harms eventually prompted action globally, including an Australian Commonwealth Government Senate Inquiry in 2017. METHOD: We analysed 425 submissions made by women (n = 417) and their advocates (n = 8) to the Australian Senate Inquiry, and documents from 5 public hearings, using deductive and inductive coding, categorisation and thematic analysis informed by three 'linked dilemmas' from healthcare quality and safety theory. We focused on women's accounts of: a) how harms arose from TVM procedures, and b) micro, meso and macro factors that contributed to their experience. Our aim was to explain, from a patient perspective, how these harms persisted in Australian healthcare, and to identify mechanisms at micro, meso and macro levels explaining quality and safety system failure. RESULTS: Our findings suggest three mechanisms explaining quality and safety failure: 1. Individual clinicians could ignore cases of TVM injury or define them as 'non-preventable'; 2. Women could not go beyond their treating clinicians to participate in defining and governing quality and safety; and. 3. Health services set thresholds for concern based on proportion of cases harmed, not absolute number or severity of harms. CONCLUSION: We argue that privileging clinical perspectives over patient perspectives in evaluating TVM outcomes allowed micro-level actors to dismiss women's lived experience, such that women's accounts of harms had insufficient or no weight at meso and macro levels. Establishing system-wide expectations regarding responsiveness to patients, and communication of patient reported outcomes in evaluation of healthcare delivery, may help prevent similar failures.

Identification of risk factors for adverse drug events in a general hospital.

Adverse events (AEs), and particularly adverse drug events (ADEs), represent a health problem as they can cause permanent damage or death. Understanding the frequency, location, and causes of ADEs can prevent harm to patients. The Global Trigger Tool, produced by the Institute for Healthcare Improvement (GTT/IHI), is widely used to identify AEs. Recognizing the profile of patients who suffer ADEs can reveal clinical or individual characteristics that predispose to the occurrence of AEs. A cross-sectional study was carried out through a retrospective analysis of 120 medical charts of patients discharged from hospital between October 2020 and April 2021. Patients over 18 years old, with a length of stay of more than 24 h, were included. The list of triggers used was from the medication module of the GTT/IHI, which was adapted for use in the institution. Two primary reviewers and a medical reviewer applied this tool. The primary reviewers independently assessed the randomized charts. A meeting to achieve consensus among the reviewers was held every 2 weeks to validate the identified ADEs; classifications were based on harm severity. Multivariate logistic regression was utilized to assess the variables that predicted the occurrence of ADEs, using the backward stepwise method. A total of 43 ADEs were identified, with a frequency of 36 per 100 admissions (43/120). Of these, five ADEs (12%) were responsible for patients being admitted to hospital. In the case of in-hospital ADEs, there were 42.2 per 1000 patients/day. The clinical manifestation of altered kidney function (16%) and the anatomical drug group of the nervous system (33%) were the most frequent ADEs. The multivariate logistic regression model was significant (×2 = 44.960, P < .001), indicating that factors such as: known drug allergy [odds ratio 5.728; 95% confidence interval (CI): 1.249, 26.274, P = .025]; being clinically hospitalized (odds ratio 7.504; 95% CI: 1.654, 34.037; P = .009); number of medicines used (odds ratio 1.100; 95% CI: 1.054, 1.148; P < .001); and being under the care of internal medicine (odds ratio 3.633; 95% CI: 1.257, 10.511; P = .017) were predictor variables associated with the occurrence of ADEs. A significant percentage of hospitalized patients experienced at least one ADE, with rates surpassing those found in similar studies. The GTT/IHI effectively assessed medication-related harm, emphasizing the need for tailored triggers based on population characteristics. Predictor variables can inform preventive strategies. Overall, the tool facilitated a localized risk assessment of medication use.

Evaluation of a Natural Language Processing Approach to Identify Diagnostic Errors and Analysis of Safety Learning System Case Review Data: Retrospective Cohort Study.

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.

Beyond SEP-1 Compliance: Assessing the Impact of Antibiotic Overtreatment and Fluid Overload in Suspected Septic Patients.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) developed the Severe Sepsis and Septic Shock Performance Measure bundle (SEP-1) metric to improve sepsis care, but evidence supporting this bundle is limited and harms secondary to compliance have not been investigated. OBJECTIVE: This study investigates the effect of an emergency department (ED) sepsis quality-improvement (QI) effort to improve CMS SEP-1 compliance, looking specifically at antibiotic overtreatment and harm from fluid resuscitation. METHODS: This was a retrospective observational study conducted between March and July 2021 with patients for whom a sepsis order set was initiated. The primary outcomes included the number of patients treated with antibiotics who were ultimately deemed nonseptic and the number of patients who developed pulmonary edema, with or without need for positive pressure ventilation (PPV), within 48 h of receiving a 30 mL/kg fluid bolus. Data were collected via nonblinded chart reviews, with a free marginal κ-calculation indicating excellent interrater reliability. RESULTS: The study cohort included 273 patients, 170 (62.3%) who were ultimately determined to be septic and 103 (37.7%) who were nonseptic. Of the 103 nonseptic patients, 82 (79.6%) received antibiotics in the ED. Of the 121 patients (44.3%) who received a 30 mL/kg bolus, 5 patients (4.1%) developed pulmonary edema and 0 of 121 patients required PPV within 48 h. CONCLUSIONS: The QI effort led to moderate rates of antibiotic overtreatment and very few patients developed pulmonary edema due to a 30 mL/kg fluid bolus.

Patient safety in orthodontic care: a scoping literature review with proposal for terminology and future research agenda.

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"). CONCLUSION: 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. REGISTRATION: PROSPERO (CRD42022371982).

Risk factors for and preventability of drug-related hospital revisits in older patients: A post-hoc analysis of a randomized clinical trial.

AIM: The aims of this study were (1) to identify older patients' risk factors for drug-related readmissions and (2) to assess the preventability of older patients' drug-related revisits. METHODS: Post hoc analysis of a randomized clinical trial with patients aged ≥65 years at eight wards within four hospitals in Sweden. (1) The primary outcome was risk factors for drug-related readmission within 12 months post-discharge. A Cox proportional hazards model was made with sociodemographic and clinical baseline characteristics. (2) Four hundred trial participants were randomly selected and their revisits (admissions and emergency department visits) were assessed to identify potentially preventable drug-related revisits, related diseases and causes. RESULTS: (1) Among 2637 patients (median age 81 years), 582 (22%) experienced a drug-related readmission within 12 months. Sixteen risk factors (hazard ratio >1, P < 0.05) related to age, previous hospital visits, medication use, multimorbidity and cardiovascular, liver, lung and peptic ulcer disease were identified. (2) The 400 patients experienced a total of 522 hospital revisits, of which 85 (16%) were potentially preventable drug-related revisits. The two most prevalent related diseases were heart failure (n = 24, 28%) and chronic obstructive pulmonary disease (n = 13, 15%). The two most prevalent causes were inadequate treatment (n = 23, 27%) and insufficient or no follow-up (n = 22, 26%). CONCLUSION: (1) Risk factors for drug-related readmissions in older hospitalized patients were age, previous hospital visits, medication use and multiple diseases. (2) Potentially preventable drug-related hospital revisits are common and might be prevented through adequate pharmacotherapy and continuity of care in older patients with cardiovascular or lung disease.

Is primary care a patient-safe setting? Prevalence, severity, nature, and causes of adverse events: numerous and mostly avoidable.

Knowing the frequency and characteristics of adverse events (AEs) is key to implementing actions that can prevent their occurrence. However, reporting systems are insufficient for this purpose and epidemiological studies are also required. Currently, the reviewing of clinical records is the gold standard method for knowing the frequency and characteristics of AEs. Research on AEs in a primary care setting has been limited and primarily focuses on specific types of events (medication errors, etc.) or patients. Large studies that search for any kind of AE in all patients are scarce. This study aimed to estimate the prevalence of AEs in the primary care setting and their characteristics. SETTING: all 262 primary health-care centres in the Madrid region (Spain) during the last quarter of 2018. DESIGN: cross-sectional descriptive study. Eligible population: subjects over 18 years of age who attended medical consultation over the last year (N = 2 743 719); a randomized sample stratified by age. MAIN OUTCOMES: age, sex, occurrence of an AE, number of consultations in the study period, avoidability, severity, place of occurrence, type of event, and contributory factors. The clinical records were reviewed by three teams, each composed of one doctor and one nurse trained and with expertise in patient safety. The SPSS software package (version 26) was used for the statistical analyses. The evaluators reviewed 1797 clinical records. The prevalence of AEs over the study period was 5.0% [95% confidence interval (CI): 4.0%‒6.0%], with higher values in women (5.7%; 95% CI: 4.6%‒6.8%;P = 0.10) and patients over 75 years of age (10.3%; 95% CI: 8.9%‒11.7%; P < 0.001). The overall occurrence per hundred consultations was estimated to be 1.58% (95% CI: 1.28%‒1.94%). Of the detected AEs, 71.3% (95% CI: 62.1%‒80.5%) were avoidable. Additionally, 60.6% (95% CI: 50.7%‒70.5%) were categorized as mild, 31.9% (95% CI: 22.4%‒41.4%) as moderate, and 7.4% (95% CI: 2.1%‒12.7%) as severe. Primary care was the occurrence setting in 76.6% (95% CI: 68.0%‒85.2%) of cases. The overall incidence of AEs related to medication was 53.2% (95% CI: 50.9%‒55.5%). The most frequent types of AEs were prescription errors (28.7%; 95% CI: 19.5%‒37.9%), followed by drug administration errors by patients (17.0%; 95% CI: 9.4%‒24.6%), and clinical assessment errors (11.7%; 95% CI: 5.2%‒18.2%). The most common contributory factors were those related to the patient (80.6%; 95% CI: 71.1%‒90.1%) and tasks (59.7%; 95% CI: 48.0%‒71.4%). A high prevalence of AEs (1 in 66 consultations) was observed, which was slightly higher than that reported in similar studies. About 3 out of 4 such events were considered to be avoidable and 1 out of 13 was severe. Prescription errors, drug administration errors by patients, and clinical assessment errors were the most frequent types of AEs. Graphical Abstract.

Compensated and non-compensated patient injury claims in internal carotid artery interventions in Finland, 2004-2017.

OBJECTIVES: Analysis of patient injuries offers possibilities for improving quality in patient care. The aim of this study was to identify errors and adverse events leading to patient injuries in the treatment of internal carotid artery stenosis (ICAS). METHODS: A retrospective analysis was performed on data from Finnish patient injury claims and patient insurance center decisions in the treatment of ICAS, 2004-2017. Contributing factors to injury were identified and evaluated. RESULTS: During the 14-year study period, 42 patient injury claims involving ICAS treatment were closed in Finland. One claim involved carotid artery stenting, and the other operations were carotid artery endarterectomies. Nine of the claims were compensated (seven for operations and two for evaluations). Fully trained vascular surgeons had carried out all the operations and evaluations. Stroke was the most common complaint in the claims (n = 12). Six of the compensated patients were symptomatic prior to the interventions. Injuries were related to errors in decision-making and patient selection in two cases. Four patients received compensation for nerve injury and three for stroke. No deaths were compensated as patient injuries. Most negative claim decisions were related to the injury having been unavoidable. CONCLUSION: Compensated patient injuries involving the treatment of ICAS are rare but often serious and mostly involve open surgery. Patient injury claims provide a valuable source of information for recognizing errors in care and offer possibilities to improve patient safety.

Interprofessional In Situ Simulation to Identify Latent Safety Threats for Quality Improvement: A Single-Center Protocol Report.

In situ simulation has frequently been used to improve team performance and provide an opportunity for the practice of critical skills and identify latent safety threats, which are undetected risks that may lead to adverse outcomes. However, the use of known quality improvement tools to prioritize and mitigate these safety threats is an area requiring further study. Over the course of 9 in situ simulations of a pediatric shock case, postcase debriefs were held to identify latent safety threats in an emergency department and a mixed pediatric and adult inpatient unit. Latent safety threats identified included structure-related threats such as inability to locate critical equipment, knowledge-based threats relating to rapid intravenous fluid administration, and communication-based threats such as lack of role designation. Identification of latent safety threats in the health care environment may assist clinician leaders in mitigating risk of patient harm. The protocol described may be adopted and applied to other critical event simulations, with structured debriefing used as a tool to identify and mitigate threats before they affect the patient.

Medication-related adverse events in health care-what have we learned? A narrative overview of the current knowledge.

PURPOSE: Although medication-related adverse events (MRAEs) in health care are vastly studied, high heterogeneity in study results complicates the interpretations of the current situation. The main objective of this study was to form an up-to-date overview of the current knowledge of the prevalence, risk factors, and surveillance of MRAEs in health care. METHODS: Electronic databases (PubMed, MEDLINE, Web of Science, and Scopus) were searched with applicable search terms to collect information on medication-related adverse events. In order to obtain an up-to-date view of MRAEs, only studies published after 2000 were accepted. RESULTS: The prevalence rates of different MRAEs vary greatly between individual studies and meta-analyses. Study setting, patient population, and detection methods play an important role in determining detection rates, which should be regarded while interpreting the results. Medication-related adverse events are more common in elderly patients and patients with lowered liver or kidney function, polypharmacy, and a large number of additional comorbidities. However, the risk of MRAEs is also significantly increased by the use of high-risk medicines but also in certain care situations. Preventing MRAEs is important as it will decrease patient mortality and morbidity but also reduce costs and functional challenges related to them. CONCLUSIONS: Medication-related adverse events are highly common and have both immediate and long-term effects to patients and healthcare systems worldwide. Conclusive solutions for prevention of all medication-related harm are impossible to create. In the future, however, the development of efficient real-time detection methods can provide significant improvements for event prevention and forecasting.

Medication errors, critical incidents, adverse drug events, and more: a review examining patient safety-related terminology in anaesthesia.

Literature focused on quantifying or reducing patient harm in anaesthesia uses a variety of labels and definitions to represent patient safety-related events, such as 'medication errors', 'adverse events', and 'critical incidents'. This review extracts and compares definitions of patient safety-related terminology in anaesthesia to examine the scope of this variability and inconsistencies. A structured review was performed in which 36 of the 769 articles reviewed met the inclusion criteria. Similar terms were grouped into six categories by similarities in keyword choice (Adverse Event, Critical Incident, Medication Error, Error, Near Miss, and Harm) and their definitions were broken down into three base components to allow for comparison. Our analysis found that the Medication Error category, which encompasses the greatest number of terms, had widely variant definitions which represent fundamentally different concepts. Definitions of terms within the other categories consistently represented relatively similar concepts, though key variations in wording remain. This inconsistency in terminology can lead to problems with synthesising, interpreting, and overall sensemaking in relation to anaesthesia medication safety. Guidance towards how 'medication errors' should be defined is provided, yet a definition will have little impact on the future of patient safety without organisations and journals taking the lead to promote, publish, and standardise definitions.

Evaluating the population-level effects of oxycodone restrictions on prescription opioid utilization in Ontario.

PURPOSE: To investigate the impact of restrictions on access to long acting oxycodone on prescription opioid use and opioid-related harms. METHODS: Administrative health data from Ontario, Canada was used to measure differences in opioids dispensed and emergency department (ED) visits for opioid-related overdose, poisoning, or substance use following provincial restrictions on access to publicly insured OxyContin (February 29, 2012) and OxyNeo (February 28, 2013). This study focused on the cohort of provincial drug insurance eligible people (people 65+ and select low-income populations) who were dispensed oxycodone prior to the restrictions. Difference-in-differences models with a propensity score matched comparison group of people who were dispensed non-oxycodone opioids were used to estimate the main effects. RESULTS: In 6 months following the delisting of OxyContin, milligrams of morphine equivalents (MMEs) per person per week for all opioids fell by an average of 7.5% in people dispensed oxycodone relative to the comparison group, and an average of 13.8% in chronic recipients of oxycodone. In the 6 months following the restrictions on OxyNeo, MMEs per person per week fell by an average of 3.1% in all people dispensed oxycodone, and 25.2% in chronic oxycodone recipients. The decline in oxycodone dispensing among chronic oxycodone recipients corresponded with an increase in dispensing of other opioid formulations, particularly hydromorphone and fentanyl. No important differences were observed for ED visits related to opioid poisoning, overdose, or substance use disorder. CONCLUSIONS: Province-wide restrictions on access to long acting oxycodone had an impact on quantities of all opioids dispensed to chronic recipients of oxycodone, but small impacts on the full population of people dispensed oxycodone; the decline in use was partially offset by increases in use of other publicly-funded opioid formulations. This study suggests that policies limiting access to specific prescription opioids led to overall reductions in publicly funded prescription opioid use, particularly in chronic oxycodone recipients, without immediate evidence of changes in opioid-related ED visits.

Compensated Patient Injuries in the Treatment of Abdominal Aortic and Iliac Artery Aneurysms in Finland: A Nationwide Patient Insurance Registry Study.

OBJECTIVES: Patient injury claims data and insurance records provide detailed information on patient injuries. This study aimed to identify the errors and adverse events that led to patient injuries in vascular surgery for the treatments of abdominal aortic aneurysms (AAA) and iliac artery aneurysms (IAA) in Finland. The study also assessed the severity and preventability of the injuries. MATERIALS AND METHODS: A retrospective analysis of Finnish Patient Insurance Centre's insurance charts of compensated patient injuries in the treatment of AAA and IAA. Records of all compensated patient injury claims involving AAA and IAA between 2004 and 2017 inclusive were reviewed. Contributing factors to injury were identified and classified. The injuries were assessed for their preventability by using the WHO Surgical Safety Checklist correctly. The degree of harm was graded by Clavien-Dindo classification. RESULTS: Twenty-six patient injury incidents were identified in the treatment of 23 patients. Typical injuries involved delays in diagnosis or treatment, errors in surgical technique or injuries to adjacent anatomic organs. Three (13.0%) patients died due to patient injury. Two deaths were caused by delays in diagnosis of ruptured abdominal aortic aneurysm (RAAA) and the third death was due to missed diagnosis of post-operative myocardial infarction. Retained foreign material caused injuries to two (8.7%) patients. One (4.3%) patient had a severe postoperative infection. Three (13.0%) patients experienced an injury to an adjacent organ. One patient had a bilateral and another a unilateral above-the-knee amputation due to patient injury. Three injuries were considered preventable. Most harms were grade IIIb Clavien-Dindo classification in which injured patients required a surgical intervention under general anesthesia. CONCLUSIONS: Compensated patient injuries involving the treatment of AAA and IAA are rare, but are often serious. Injuries were identified during all stages of care. Most injuries involved open surgical procedures.

The blame game- experiences of female residents in obstetrics & gynecology regarding lapses in patient safety.

Objectives: Primary objective was to explore experiences of female residents of Obstetrics and Gynecology (OB/GYN) regarding lapses in patient safety (PS) while secondary objective was to explore factors hampering or favouring improvement of PS in OB/GYN. Methods: In this qualitative narrative study carried out in OB/GYN department of Combined Military Hospital (CMH) Lahore for six months from 1st April to 30th September 2021, six fourth-year residents were asked to write narratives of their personal experiences of medical error (witnessed or committed) in detail and reflect on those experiences, which were then transcribed. Code labels and themes were assigned manually. Interpretation of these themes was done after thematic content analysis. Results: Six, fourth-year female residents with a mean age of 28.6±1.8 participated in the study. Two main themes with sub-themes were identified: 1) Challenges in patient safety (Personal challenges, Workplace challenges, Barriers to PS), 2) Lessons learnt from experiences (Self-improvement and; Promotion of patient safety culture). Heavy workload with long working hours, lack of communication and teamwork, lack of experience and inadequate supervision were major factors involved in PS lapses experienced by residents. Conclusion: Incidents of Patient Safety (PS) lapses had a strong impact on the emotional and professional life of residents. Formal PS training with improvement of working conditions may help promote PS culture.

Association of Resident Shift Length with Procedural Complications.

BACKGROUND: Training programs for resident physicians struggle to balance the need for clinical experience with the impact of fatigue on patient safety. The length of shifts worked by emergency medicine (EM) residents is likely an important determinant of resident fatigue. OBJECTIVE: Assess the impact of a longer clinical shift on procedural competency. METHODS: We conducted a retrospective chart review of arterial line placements, central venous catheterizations, tube thoracostomies, endotracheal intubations, and lumbar punctures performed by EM residents working 12-h shifts in the emergency department of an academic medical center over an academic year. We compared complication rates between procedures performed in the first 8 vs. the last 4 h of a 12-h shift. Procedures without complication were defined as successful on first-pass attempt and without a downstream mechanical or medical complication. Multivariable modified Poisson regression was used to simultaneously control for possible confounders affecting procedure success. RESULTS: We identified 548 eligible procedures: 307 performed in the first 8 h of a 12-h shift and 241 in the last 4 h. The complication rate across all procedures was higher in the last 4 h of the shift (pooled risk ratio 1.41, 95% confidence interval 1.18-1.67). This effect persisted when adjusting for potential confounders (adjusted risk ratio 1.42, 95% confidence interval 1.19-1.69). CONCLUSION: Overall, complication rates of included procedures performed by EM residents were higher during the last 4 vs. first 8 h of a 12-h shift. Training programs should consider the impact of resident fatigue on patient safety when making work schedules.

Adverse events in psychiatry: a national cohort study in Sweden with a unique psychiatric trigger tool.

BACKGROUND: The vast majority of patient safety research has focused on somatic health care. Although specific adverse events (AEs) within psychiatric healthcare have been explored, the overall level and nature of AEs is sparsely investigated. METHODS: Cohort study using a retrospective record review based on a two-step trigger tool methodology in the charts of randomly selected patients 18 years or older admitted to the psychiatric acute care departments in all Swedish regions from January 1 to June 30, 2017. Hospital care together with corresponding outpatient care were reviewed as a continuum, over a maximum of 3 months. The AEs were categorised according to type, severity and preventability. RESULTS: In total, the medical records of 2552 patients were reviewed. Among the patients, 50.4% were women and 49.6% were men. The median (range) age was 44 (18-97) years for women and 44.5 (18-93) years for men. In 438 of the reviewed records, 720 AEs were identified, corresponding to the AEs identified in 17.2% [95% confidence interval, 15.7-18.6] of the records. The majority of AEs resulted in less or moderate harm, and 46.2% were considered preventable. Prolonged disease progression and deliberate self-harm were the most common types of AEs. AEs were significantly more common in women (21.5%) than in men (12.7%) but showed no difference between age groups. Severe or catastrophic harm was found in 2.3% of the records, and the majority affected were women (61%). Triggers pointing at deficient quality of care were found in 78% of the records, with the absence of a treatment plan being the most common. CONCLUSIONS: AEs are common in psychiatric care. Aside from further patient safety work, systematic interventions are also warranted to improve the quality of psychiatric care.

Transvaginal mesh, gender and the ethics of clinical innovation.

On 10 October 2018, Australian Health Minister Greg Hunt issued a national apology to the Australian women who experienced 'horrific outcomes' following surgery using transvaginal mesh-acknowledging the 'historic agony and pain that has come from mesh implantation'. This apology followed many decades of 'innovative' use of transvaginal mesh for the treatment of pelvic organ prolapse. We use the case of transvaginal mesh to explore how clinical innovation may not only harm patients, but also entrench vulnerability and exacerbate existing inequities-in this case, those relating to gender.

Our first review: an evaluation of effectiveness of root cause analysis recommendations in Hong Kong public hospitals.

BACKGROUND: To evaluate the effectiveness of root cause analysis (RCA) recommendations and propose possible ways to enhance its quality in Hong Kong public hospitals. METHODS: A retrospective cross-sectional study was performed across 43 public hospitals and institutes in Hong Kong, reviewing RCA reports of all Sentinel Events and Serious Untoward Events within a two-year period. The incident nature, types of root causes and strengths of recommendations were analysed. The RCA recommendations were categorised as 'strong', 'medium' or 'weak' strengths utilizing the US's Veteran Affairs National Center for Patient Safety action hierarchy. RESULTS: A total of 214 reports from October 2016 to September 2018 were reviewed. These reports generated 504 root causes, averaging 2.4 per RCA report, and comprising 249 (49%) system, 233 (46%) staff behavioural and 22 (4%) patient factors. There were 760 recommendations identified in the RCA reports with an average of 3.6 per RCA. Of these, 18 (2%) recommendations were rated strong, 116 (15%) medium and 626 (82%) weak. Most recommendations were related to 'training and education' (466, 61%), 'additional study/review' (104, 14%) and 'review/enhancement of policy/guideline' (39, 5%). CONCLUSIONS: This study provided insights about the effectiveness of RCA recommendations across all public hospitals in Hong Kong. The results showed a high proportion of root causes were attributed to staff behavioural factors and most of the recommendations were weak. The reasons include the lack of training, tools and expertise, appropriateness of panel composition, and complicated processes in carrying out large scale improvements. The Review Team suggested conducting regular RCA training, adopting easy-to-use tools, enhancing panel composition with human factors expertise, promoting an organization-wide safety culture to staff and aggregating analysis of incidents as possible improvement actions.

Patient-related factors associated with an increased risk of being a reported case of preventable harm in first-line health care: a case-control study.

BACKGROUND: Patient safety issues in primary health care and in emergency departments have not been as thoroughly explored as patient safety issues in the hospital setting. Knowledge is particularly sparse regarding which patients have a higher risk of harm in these settings. The objective was to evaluate which patient-related factors were associated with risk of harm in patients with reports of safety incidents. METHODS: A case-control study performed in primary health care and emergency departments in Sweden. In total, 4536 patients (cases) and 44,949 controls were included in this study. Cases included patients with reported preventable harm in primary health care and emergency departments from January 1st, 2011 until December 31st, 2016. RESULTS: Psychiatric disease, including all psychiatric diagnoses regardless of severity, nearly doubled the risk of being a reported case of preventable harm (odds ratio, 1.96; p < 0.001). Adjusted for income and education there was still an increased risk (odds ratio, 1.69; p < 0.001). The preventable harm in this group was to 46% diagnostic errors of somatic disease. CONCLUSION: Patients with psychiatric illness are at higher risk of preventable harm in primary care and the emergency department. Therefore, this group needs extra attention to prevent harm.

Adverse events in Malaysia: Associations with nurse's ethnicity and experience, hospital size, accreditation, and teaching status.

PURPOSE: In Malaysia, private healthcare sector has become a major player in delivering healthcare services alongside the government healthcare sector. However, wide disparities in health outcomes have been recorded, and adverse events in these contexts have yet to be explored. The purpose of this study was to explore associations between nurse's ethnicity and experience, hospital size, accreditation, and teaching status with adverse events in Malaysian private hospitals. METHODS: A cross-sectional survey was conducted in 12 private hospitals in Malaysia. A total of 652 (response rate = 61.8%) nurses participated in the study. Data were collected using self-administered questionnaire on nurses' characteristic, adverse events and events reporting, and perceived patient safety. RESULTS: Patient and family complaints events were the most common adverse events in Malaysian private hospitals as result of increased cost of care (3.24 ± 0.95) and verbal miscommunication (3.52 ± 0.87). CONCLUSION: Hospital size, accreditation status, teaching status, and nurse ethnicity had a mixed effect on patient safety, perceived adverse events, and events reporting. Policy makers can benefit that errors are related to several human and system related factors. Several system reforms and multidisciplinary efforts were recommended for optimizing health, healthcare and preventing patient harm.