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In the article, the author discusses the perspectives of patients on the trust and trustworthiness of health care organizations in the U.S. Other topics include the clinician behaviors that affect patients' perception of their trustworthiness like communication, care or compassion, and perceived competence, and the conceptual model of trustworthiness and trust as developed by Andrew Anderson and Derek Griffith.

Medical error is one of the most critical challenges facing medical services. They pose a substantial threat to patient safety, and their costs draw attention from policymakers, health care planners and researchers. We aim to make a realistic estimation of medical error incidence and related costs and identify factors influencing this incidence in Iranian hospitals. In the first phase of this multi-method study, through two reviews of systematic reviews and a meta-analysis, we will estimate the incidence of medical errors and the strategies to reduce them. We will extract available data among 41 hospitals supervised by the East Azerbaijan University in the second phase. We will also develop a model and use a Delphi method to predict medical errors incidence and calibrate our model output using the Monte Carlo simulation. We will compare this estimation with the incidence rate based on meta-analysis results from the first phase. In the third phase, we will investigate the relationship between several factors potentially influencing medical error incidence. In the fourth phase, we will estimate costs associated with medical errors by conducting a patient records review and matching those with claims related to medical errors. In the fifth phase, we will present a policy brief related to strategies for medical errors and associated costs reduction in Iran. Our findings could benefit Iranian and policymakers in other countries to reduce medical errors and associated costs. [ABSTRACT FROM AUTHOR]

Background: To advance orthopaedic surgical skills training and assessment, more rigorous and objective performance measures are needed. In hip fracture repair, the tip-apex distance is a commonly used summative performance metric with clear clinical relevance, but it does not capture the skill exercised during the process of achieving the final implant position. This study introduces and evaluates a novel Image-based Decision Error Analysis (IDEA) score that better captures performance during fluoroscopically-assisted wire navigation.Questions/purposes: (1) Can wire navigation skill be objectively measured from a sequence of fluoroscopic images? (2) Are skill behaviors observed in a simulated environment also exhibited in the operating room? Additionally, we sought to define an objective skill metric that demonstrates improvement associated with accumulated surgical experience.Methods: Performance was evaluated both on a hip fracture wire navigation simulator and in the operating room during actual fracture surgery. After examining fluoroscopic image sequences from 176 consecutive simulator trials (performed by 58 first-year orthopaedic residents) and 21 consecutive surgical procedures (performed by 19 different orthopaedic residents and one attending orthopaedic surgeon), three main categories of erroneous skill behavior were identified: off-target wire adjustments, out-of-plane wire adjustments, and off-target drilling. Skill behaviors were measured by comparing wire adjustments made between consecutive images against the goal of targeting the apex of the femoral head as part of our new IDEA scoring methodology. Decision error metrics (frequency, magnitude) were correlated with other measures (image count and tip-apex distance) to characterize factors related to surgical performance on both the simulator and in the operating room. An IDEA composite score integrating decision errors (off-target wire adjustments, out-of-plane wire adjustments, and off-target drilling) and the final tip-apex distance to produce a single metric of overall performance was created and compared with the number of hip wire navigation cases previously completed (such as surgeon experience levels).Results: The IDEA methodology objectively analyzed 37,000 images from the simulator and 688 images from the operating room. The number of decision errors (7 ± 5 in the operating room and 4 ± 3 on the simulator) correlated with fluoroscopic image count (33 ± 14 in the operating room and 20 ± 11 on the simulator) in both the simulator and operating room environments (R2 = 0.76; p < 0.001 and R2 = 0.71; p < 0.001, respectively). Decision error counts did not correlate with the tip-apex distance (16 ± 4 mm in the operating room and 12 ± 5 mm on the simulator) for either the simulator or the operating room (R2 = 0.08; p = 0.15 and R2 = 0.03; p = 0.47, respectively), indicating that the tip-apex distance is independent of decision errors. The IDEA composite score correlated with surgical experience (R2 = 0.66; p < 0.001).Conclusion: The fluoroscopic images obtained in the course of placing a guide wire contain a rich amount of information related to surgical skill. This points the way to an objective measure of skill that also has potential as an educational tool for residents. Future studies should expand this analysis to the wide variety of procedures that rely on fluoroscopic images.Clinical Relevance: This study has shown how resident skill development can be objectively assessed from fluoroscopic image sequences. The IDEA scoring provides a basis for evaluating the competence of a resident. The score can be used to assess skill at key timepoints throughout residency, such as when rotating onto/off of a new surgical service and before performing certain procedures in the operating room, or as a tool for debriefing/providing feedback after a procedure is completed. [ABSTRACT FROM AUTHOR]

Importance: Tracheal intubation is one of the most commonly performed and high-risk interventions in critically ill patients. Limited information is available on adverse peri-intubation events.Objective: To evaluate the incidence and nature of adverse peri-intubation events and to assess current practice of intubation in critically ill patients.Design, Setting, and Participants: The International Observational Study to Understand the Impact and Best Practices of Airway Management in Critically Ill Patients (INTUBE) study was an international, multicenter, prospective cohort study involving consecutive critically ill patients undergoing tracheal intubation in the intensive care units (ICUs), emergency departments, and wards, from October 1, 2018, to July 31, 2019 (August 28, 2019, was the final follow-up) in a convenience sample of 197 sites from 29 countries across 5 continents.Exposures: Tracheal intubation.Main Outcomes and Measures: The primary outcome was the incidence of major adverse peri-intubation events defined as at least 1 of the following events occurring within 30 minutes from the start of the intubation procedure: cardiovascular instability (either: systolic pressure <65 mm Hg at least once, <90 mm Hg for >30 minutes, new or increase need of vasopressors or fluid bolus >15 mL/kg), severe hypoxemia (peripheral oxygen saturation <80%) or cardiac arrest. The secondary outcomes included intensive care unit mortality.Results: Of 3659 patients screened, 2964 (median age, 63 years; interquartile range [IQR], 49-74 years; 62.6% men) from 197 sites across 5 continents were included. The main reason for intubation was respiratory failure in 52.3% of patients, followed by neurological impairment in 30.5%, and cardiovascular instability in 9.4%. Primary outcome data were available for all patients. Among the study patients, 45.2% experienced at least 1 major adverse peri-intubation event. The predominant event was cardiovascular instability, observed in 42.6% of all patients undergoing emergency intubation, followed by severe hypoxemia (9.3%) and cardiac arrest (3.1%). Overall ICU mortality was 32.8%.Conclusions and Relevance: In this observational study of intubation practices in critically ill patients from a convenience sample of 197 sites across 29 countries, major adverse peri-intubation events-in particular cardiovascular instability-were observed frequently. [ABSTRACT FROM AUTHOR]

Abstract: This study examined the prevalence and predictors of moral injury (MI) symptoms in 181 health care professionals (HPs; 71% physicians) recruited from Duke University Health Systems in Durham, NC. Participants completed an online questionnaire between November 13, 2019, and March 12, 2020. Sociodemographic, clinical, religious, depression/anxiety, and clinician burnout were examined as predictors of MI symptoms, assessed by the Moral Injury Symptoms Scale-Health Professional, in bivariate and stepwise multivariate analyses. The prevalence of MI symptoms causing at least moderate functional impairment was 23.9%. Younger age, shorter time in practice, committing medical errors, greater depressive or anxiety symptoms, greater clinician burnout, no religious affiliation, and lower religiosity correlated with MI symptoms in bivariate analyses. Independent predictors in multivariate analyses were the commission of medical errors in the past month, lower religiosity, and, especially, severity of clinician burnout. Functionally limiting MI symptoms are present in a significant proportion of HPs and are associated with medical errors and clinician burnout. [ABSTRACT FROM AUTHOR]

The "replication crisis" has been attributed to perverse incentives that lead to selective reporting and misinterpretations of P-values and confidence intervals. A crude fix offered for this problem is to lower testing cut-offs (α levels), either directly or in the form of null-biased multiple comparisons procedures such as naïve Bonferroni adjustments. Methodologists and statisticians have expressed positions that range from condemning all such procedures to demanding their application in almost all analyses. Navigating between these unjustifiable extremes requires defining analysis goals precisely enough to separate inappropriate from appropriate adjustments. To meet this need, I here review issues arising in single-parameter inference (such as error costs and loss functions) that are often skipped in basic statistics, yet are crucial to understanding controversies in testing and multiple comparisons. I also review considerations that should be made when examining arguments for and against modifications of decision cut-offs and adjustments for multiple comparisons. The goal is to provide researchers a better understanding of what is assumed by each side and to enable recognition of hidden assumptions. Basic issues of goal specification and error costs are illustrated with simple fixed cut-off hypothesis testing scenarios. These illustrations show how adjustment choices are extremely sensitive to implicit decision costs, making it inevitable that different stakeholders will vehemently disagree about what is necessary or appropriate. Because decisions cannot be justified without explicit costs, resolution of inference controversies is impossible without recognising this sensitivity. Pre-analysis statements of funding, scientific goals, and analysis plans can help counter demands for inappropriate adjustments, and can provide guidance as to what adjustments are advisable. Hierarchical (multilevel) regression methods (including Bayesian, semi-Bayes, and empirical-Bayes methods) provide preferable alternatives to conventional adjustments, insofar as they facilitate use of background information in the analysis model, and thus can provide better-informed estimates on which to base inferences and decisions. [ABSTRACT FROM AUTHOR]

Aims: (a) To identify the frequencies and reasons for missed care by nursing aides in long‐term care facilities and (b) to clarify the correlation between missed care and the characteristics of nursing aides and facilities. Background: Missed care by nursing aides in long‐term care facilities affects the resident's quality of care and, therefore, requires attention. Methods: A cross‐sectional study was conducted, wherein 184 nursing aides and 80 registered nurses were recruited from 10 long‐term care facilities. Results: (a) The most frequently missed item of care by nursing aides was assistance with body cleaning (30.4%). (b) Among all participants, 90.2%, 89.8% and 64% indicated poor communication, labour shortages and material resource insufficiencies, respectively, as the reason for missed care. (c) Participants who perceived staff to be insufficient missed care tasks more frequently than those who perceived staff to be sufficient (p <.05). Conclusions: Missed handover and insufficient nursing aides on duty were identified as the primary reasons for missed care. Implications for Nursing Management: Handover as a nursing process should be improved to promote accuracy and continuity. Flexibility in human resources should be maintained to respond adequately to resident's emergencies, thereby ensuring effective completion of the job. [ABSTRACT FROM AUTHOR]

Introduction: In Norway, all patient-reported claims for compensation are evaluated by The Norwegian System of Patient Injury Compensation (NPE). The number of claims from women with cervical cancer is rising, and the approval rate is high. Our aim was to study claims for compensation from women with cervical cancer to identify the type of failures, when, during the time-course of treatment, the medical failures occurred, and the consequences of the failures.Material and Methods: A retrospective, descriptive study of claims for compensation to NPE from cervical cancer patients during a 12-year period, from 2007 through 2018. We used anonymized medical expert statements and summaries of NPE cases.Results: In all, 161 women claimed compensation for alleged medical failure related to cervical cancer. Compensation was approved for 100 (62%) women. Mean age at the time of alleged failure was 37.5 years (SD ±9.9). The main reasons why women sought medical attention were routine cervical screening (56%), or vaginal bleeding or discharge (30%). In approved cases, incorrect evaluation of cytology and histology was the cause of most failures (72%). Mean delay of cervical cancer diagnosis for approved cases was 28 months (SD ±22). Treatment not in accordance with guidelines was the cause of failure in 2% of the cases, and failure during follow up was the cause of failure in 12%. Consequences of the failures were as follows: worsening of cancer prognosis (89%), treatment-induced adverse effects, such as loss of fertility (43%) and/or loss of ovarian function in premenopausal women (50%), and permanent injury after chemo-radiation (27%). Seven women (7%) died, most probably as a consequence of the failure.Conclusions: The main cause of medical failure in women with cervical cancer was incorrect pathological diagnosis. The main consequences of failures were worsening of cancer prognosis and treatment-induced adverse effects. Increased focus on the quality of pathological examinations, and better routines in all parts of the cervical examinations might improve patient safety for women in risk of cervical cancer. [ABSTRACT FROM AUTHOR]

Aims: There are limited data regarding critical congenital heart disease (CCHD) from middle-income countries (MIC). This study aims to determine the birth prevalence, rate of late diagnosis, and influence of timing of diagnosis on the outcome of CCHD. Setting and Design: Retrospective observational cohort study in the State of Johor, Malaysia. Subjects and Methods: All infants born between January 2006 and December 2015 with a diagnosis of CCHD, defined as infants with duct-dependent lesions or cyanotic heart disease who may die without early intervention. The late diagnosis was defined as a diagnosis of CCHD after 3 days of age. Results: Congenital heart disease was diagnosed in 3557 of 531,904 live-born infants and were critical in 668 (18.7%). Of 668, 347 (52%) had duct-dependent pulmonary circulation. The birth prevalence of CCHD was 1.26 (95% confidence interval: 1.16-1.35) per 1000 live births, with no significant increase over time. The median age of diagnosis was 4 days (Q1 1, Q3 26), with 61 (9.1%) detected prenatally, and 342 (51.2%) detected late. The highest rate of late diagnosis was observed in coarctation of the aorta with a rate of 74%. Trend analysis shows a statistically significant reduction of late diagnosis and a significant increase in prenatal detection. However, Cox regression analysis shows the timing of diagnosis does not affect the outcome of CCHD. Conclusions: Due to limited resources in the MIC, the late diagnosis of CCHD is high but does not affect the outcome. Nevertheless, the timing of diagnosis has improved over time. [ABSTRACT FROM AUTHOR]

Purpose: Patient safety failures are recognised as a global threat to public health, yet remain a leading cause of death internationally. Vulnerable children are inversely more in need of high-quality primary health and social-care but little is known about the quality of care received. Using national patient safety data, this study aimed to characterise primary care-related safety incidents among vulnerable children.Methods: This was a cross-sectional mixed methods study of a national database of patient safety incident reports occurring in primary care settings. Free-text incident reports were coded to describe incident types, contributory factors, harm severity and incident outcomes. Subsequent thematic analyses of a purposive sample of reports was undertaken to understand factors underpinning problem areas.Results: Of 1183 reports identified, 572 (48%) described harm to vulnerable children. Sociodemographic analysis showed that included children had child protection-related (517, 44%); social (353, 30%); psychological (189, 16%) or physical (124, 11%) vulnerabilities. Priority safety issues included: poor recognition of needs and subsequent provision of adequate care; insufficient provider access to accurate information about vulnerable children, and delayed referrals between providers.Conclusion: This is the first national study using incident report data to explore unsafe care amongst vulnerable children. Several system failures affecting vulnerable children are highlighted, many of which pose internationally recognised challenges to providers aiming to deliver safe care to this at-risk cohort. We encourage healthcare organisations globally to build on our findings and explore the safety and reliability of their healthcare systems, in order to sustainably mitigate harm to vulnerable children. [ABSTRACT FROM AUTHOR]

Background: The effects on patient safety of eliminating extended-duration work shifts for resident physicians remain controversial.Methods: We conducted a multicenter, cluster-randomized, crossover trial comparing two schedules for pediatric resident physicians during their intensive care unit (ICU) rotations: extended-duration work schedules that included shifts of 24 hours or more (control schedules) and schedules that eliminated extended shifts and cycled resident physicians through day and night shifts of 16 hours or less (intervention schedules). The primary outcome was serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review.Results: The characteristics of ICU patients during the two work schedules were similar, but resident physician workload, described as the mean (±SD) number of ICU patients per resident physician, was higher during the intervention schedules than during the control schedules (8.8±2.8 vs. 6.7±2.2). Resident physicians made more serious errors during the intervention schedules than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53; 95% confidence interval [CI], 1.37 to 1.72; P<0.001). The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71). There was wide variability among sites, however; errors were lower during intervention schedules than during control schedules at one site, rates were similar during the two schedules at two sites, and rates were higher during intervention schedules than during control schedules at three sites. In a secondary analysis that was adjusted for the number of patients per resident physician as a potential confounder, intervention schedules were no longer associated with an increase in errors.Conclusions: Contrary to our hypothesis, resident physicians who were randomly assigned to schedules that eliminated extended shifts made more serious errors than resident physicians assigned to schedules with extended shifts, although the effect varied by site. The number of ICU patients cared for by each resident physician was higher during schedules that eliminated extended shifts. (Funded by the National Heart, Lung, and Blood Institute; ROSTERS ClinicalTrials.gov number, NCT02134847.). [ABSTRACT FROM AUTHOR]

Background: Health care complaints are an underutilized resource for quality and safety improvement. Most research on health care complaints is focused on secondary care. However, there is also a need to consider patient safety in general practice, and complaints could inform quality and safety improvement.Objective: This review aimed to synthesize the extant research on complaints in general practice.Methods: Five electronic databases were searched: Medline, Web of Science, CINAHL, PsycINFO and Academic Search Complete. Peer-reviewed studies describing the content, impact of and motivation for complaints were included and data extracted. Framework synthesis was conducted using the Healthcare Complaints Analysis Tool (HCAT) as an organizing framework. Methodological quality was appraised using the Quality Assessment Tool for Studies with Diverse Designs (QATSDD).Results: The search identified 2960 records, with 21 studies meeting inclusion criteria. Methodological quality was found to be variable. The contents of complaints were classified using the HCAT, with 126 complaints (54%) classified in the Clinical domain, 55 (23%) classified as Management and 54 (23%) classified as Relationships. Motivations identified for making complaints included quality improvement for other patients and monetary compensation. Complaints had both positive and negative impacts on individuals and systems involved.Conclusion: This review highlighted the high proportion of clinical complaints in general practice compared to secondary care, patients' motivations for making complaints and the positive and negative impacts that complaints can have on health care systems. Future research focused on the reliable coding of complaints and their use to improve quality and safety in general practice is required. [ABSTRACT FROM AUTHOR]

Background: Both morbidity and mortality data (MMD) and learning curves (LCs) do not provide information on the nature of intraoperative errors and their mechanisms when these adversely impact on patient outcome. OCHRA was developed specifically to address the unmet surgical need for an objective assessment technique of the quality of technical execution of operations at individual operator level. The aim of this systematic review was to review of OCHRA as a method of objective assessment of surgical operative performance.Methods: Systematic review based on searching 4 databases for articles published from January 1998 to January 2019. The review complies with Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines and includes original publications on surgical task performance based on technical errors during operations across several surgical specialties.Results: Only 26 published studies met the search criteria, indicating that the uptake of OCHRA during the study period has been low. In 31% of reported studies, the operations were performed by fully qualified consultant/attending surgeons and by surgical trainees in 69% in approved training programs. OCHRA identified 7869 consequential errors (CE) during the conduct of 719 clinical operations (mean = 11 CEs). It also identified 'hazard zones' of operations and proficiency-gain curves (P-GCs) that confirm attainment of persistent competent execution of specific operations by individual trainee surgeons. P-GCs are both surgeon and operation specific.Conclusions: Increased OCHRA use has the potential to improve patient outcome after surgery, but this is a contingent progress towards automatic assessment of unedited videos of operations. The low uptake of OCHRA is attributed to its labor-intensive nature involving human factors (cognitive engineering) expertise. Aside from faster and more objective peer-based assessment, this development should accelerate increased clinical uptake and use of the technique in both routine surgical practice and surgical training. [ABSTRACT FROM AUTHOR]

Healthcare can cause harm. The goal of this study is to evaluate the association between the occurrence of adverse events (AEs) and morbidity-mortality in critically ill children. A prospective cohort study was designed. All children admitted to the Pediatric Intensive Care Unit (PICU) between August 2016 and July 2017 were followed. An AE was considered any harm associated with a healthcare-related incident. AEs were identified in two steps: first, adverse clinical incidents (ACI) were recognized through direct observation and active surveillance by PICU physicians, and then the patient safety committee evaluated every ACI to define which would be considered an AE. The outcome was hospital morbidity-mortality. There were 467 ACI registered, 249 (53.31%) were considered AEs and the rate was 4.27/100 patient days. From the 842 children included, 142 (16.86%) suffered AEs, 39 (4.63%) experienced morbidity-mortality: 33 (3.92%) died, and 6 (0.71%) had morbidity. Multivariate analysis revealed that the occurrence of AEs was significantly associated with morbidity-mortality, OR 5.70 (CI95% 2.58-12.58, p = 0.001). This association was independent of age and severity of illness score.Conclusion: Experiencing AEs significantly increased the risk of morbidity-mortality in this cohort of PICU children.What is Known:• Many children suffer healthcare-associated harm during pediatric intensive care hospitalization.What is New:• This prospective cohort study shows that experiencing adverse events during pediatric intensive care hospitalization significantly increases the risk of morbidity and mortality independent of age and severity of illness at admission. [ABSTRACT FROM AUTHOR]

Importance: Recommendations in the United States suggest limiting the number of patient records displayed in an electronic health record (EHR) to 1 at a time, although little evidence supports this recommendation.Objective: To assess the risk of wrong-patient orders in an EHR configuration limiting clinicians to 1 record vs allowing up to 4 records opened concurrently.Design, Setting, and Participants: This randomized clinical trial included 3356 clinicians at a large health system in New York and was conducted from October 2015 to April 2017 in emergency department, inpatient, and outpatient settings.Interventions: Clinicians were randomly assigned in a 1:1 ratio to an EHR configuration limiting to 1 patient record open at a time (restricted; n = 1669) or allowing up to 4 records open concurrently (unrestricted; n = 1687).Main Outcomes and Measures: The unit of analysis was the order session, a series of orders placed by a clinician for a single patient. The primary outcome was order sessions that included 1 or more wrong-patient orders identified by the Wrong-Patient Retract-and-Reorder measure (an electronic query that identifies orders placed for a patient, retracted, and then reordered shortly thereafter by the same clinician for a different patient).Results: Among the 3356 clinicians who were randomized (mean [SD] age, 43.1 [12.5] years; mean [SD] experience at study site, 6.5 [6.0] years; 1894 females [56.4%]), all provided order data and were included in the analysis. The study included 12 140 298 orders, in 4 486 631 order sessions, placed for 543 490 patients. There was no significant difference in wrong-patient order sessions per 100 000 in the restricted vs unrestricted group, respectively, overall (90.7 vs 88.0; odds ratio [OR], 1.03 [95% CI, 0.90-1.20]; P = .60) or in any setting (ED: 157.8 vs 161.3, OR, 1.00 [95% CI, 0.83-1.20], P = .96; inpatient: 185.6 vs 185.1, OR, 0.99 [95% CI, 0.89-1.11]; P = .86; or outpatient: 7.9 vs 8.2, OR, 0.94 [95% CI, 0.70-1.28], P = .71). The effect did not differ among settings (P for interaction = .99). In the unrestricted group overall, 66.2% of the order sessions were completed with 1 record open, including 34.5% of ED, 53.7% of inpatient, and 83.4% of outpatient order sessions.Conclusions and Relevance: A strategy that limited clinicians to 1 EHR patient record open compared with a strategy that allowed up to 4 records open concurrently did not reduce the proportion of wrong-patient order errors. However, clinicians in the unrestricted group placed most orders with a single record open, limiting the power of the study to determine whether reducing the number of records open when placing orders reduces the risk of wrong-patient order errors.Trial Registration: clinicaltrials.gov Identifier: NCT02876588. [ABSTRACT FROM AUTHOR]

Background: At Freiburg University Medical Center, chemotherapy prescriptions are processed via a computerized physician order entry (CPOE) tool and clinically checked by a designated chemotherapy surveillance team. Any error detected is reported instantly, corrected, and prospectively recorded. The objective of the current study was to gain insight into the causes, potential consequences, and future preventability of chemotherapy prescribing errors.Methods: A detailed analysis of 18,823 consecutive antineoplastic orders placed in 2013 through 2014 was performed. In cooperation with information technology (IT) specialists, the intercepted errors were analyzed for effective future prevention using IT measures. Potential error consequences were determined by case discussions between pharmacists and physicians.Results: Within 24 months, a total of 406 chemotherapy prescribing errors were intercepted that affected 375 (2%) of the total orders. Errors were classified as clinically relevant in 279 of the chemotherapy orders (1.5%). In these cases, reduced therapeutic efficacy (0.44%), the need for increased monitoring (0.48%), prolonged hospital stay (0.55%), and fatality (0.02%) were avoided as potential consequences. The most efficient conventional measures for error prevention comprised checking the order history and patient's medical record, and a detailed knowledge of chemotherapy protocols. Of all the errors analyzed, 61% would be avoided through further software development. The improvements identified are implemented through a validated next-generation CPOE tool.Conclusions: The upgraded CPOE tool can be shared across other hospitals to raise safety standards and spread potential benefits across a wider patient population. The current analysis also highlighted that approximately 30% to 40% of errors cannot be avoided electronically. Therefore, pharmacovigilance initiatives remain indispensable. [ABSTRACT FROM AUTHOR]

Background: Parenteral nutrition (PN) is associated with material and manpower costs and requires preparation time. The aim of this study was to evaluate the cost of PN using multichamber bags (MCBs) compared with hospital-compounded bags (COBs). The secondary aim of this study was to assess and compare preparation time and errors related to the production and preparation processes of PN bags.Materials and Methods: A prospective, observational, cost-accounting study was conducted in 10 Spanish hospital pharmacy services. The cost assessments included components, raw materials, and hospital staff. Only PN bags with equivalent volume and nutrition value were included in the analyses. Assessment of errors related to PN was performed simultaneously with the cost and time comparison analyses.Results: Among the 597 PN bags (295 MCBs, 302 COBs) evaluated, 392 PN bags (295 MCBs, 97 COBs) had an equivalent volume and nutrition value. The mean (standard deviation) total cost of the MCB was $62.11 ($12.34) per bag compared with $67.54 ($8.50) per bag for COBs, resulting in a significant cost savings of $5.71. On average, the time required to prepare an MCB was 38 minutes shorter (P < .001). Significantly fewer total number (percent) of errors was observed in the preparation of MCBs (3 [1.0%]) compared with COBs (15 [5.0%]); P < .01).Conclusion: The use of MCBs results in significant savings in cost and preparation time, which may have a beneficial effect on the economic burden associated with PN as well as a reduction in errors related to PN preparation. [ABSTRACT FROM AUTHOR]

Purpose: Currently, there is no approved therapy for cancer cachexia. According to European and American regulatory agencies, physical function improvements would be approvable co-primary endpoints of new anti-cachexia medications. As physical functioning is in part dependent on cardiac functioning, we aimed to explore the cardiac status of a group of patients meeting current criteria for inclusion in cachexia clinical trials.Methods: Seventy treatment-naive patients with metastatic NSCLC [36 (51.4%) male; 96% ECOG 0-1; eligible for carboplatin-based therapy and meeting eligibility criteria for cachexia clinical trials] were recruited before the start of first-line carboplatin-based chemotherapy. Patients were evaluated by echocardiography, electrocardiography, and scales for fatigue and dyspnea. Computed tomography cross-sectional images were utilized for body composition analysis.Results: In 9/70 patients (12.8%), echocardiography allowed discovery of clinically relevant cardiac disorders [seven patients with left ventricular ejection fraction (LVEF) 32%-47%; one patient with severe right ventricular dilation and severe pulmonary hypertension and one patient with severe pericardial effusion warranted hospitalization and drainage]. Another 10/70 (14.3%) patients had diastolic dysfunction with preserved LVEF. The cardiac conditions were associated with aggravated fatigue (p < 0.05), dyspnea (p < 0.05), and anemia (p = 0.06). Five out of seven patients with LVEF < 50% were sarcopenic and one was borderline sarcopenic.Conclusion: Baseline cardiac status of the metastatic NSCLC patients adds potential heterogeneity for anti-cachexia clinical trials. Detailed cardiac screening data might be useful for inclusion/exclusion criteria, randomization, and post hoc analysis. [ABSTRACT FROM AUTHOR]

Objective: Narcolepsy is a lifelong disease, manifesting with excessive daytime sleepiness and cataplexy, arising between childhood and young adulthood. The diagnosis is typically made after a long delay that burdens the disease severity. The aim of the project, promoted by the "Associazione Italiana Narcolettici e Ipersonni" is to develop Red Flags to detect symptoms for early referral, targeting non-sleep medicine specialists, general practitioners, and pediatricians.Materials and Methods: A multidisciplinary panel, including patients, public institutions, and representatives of national scientific societies of specialties possibly involved in the diagnostic process of suspected narcolepsy, was convened. The project was accomplished in three phases. Phase 1: Sleep experts shaped clinical pictures of narcolepsy in pediatric and adult patients. On the basis of these pictures, Red Flags were drafted. Phase 2: Representatives of the scientific societies and patients filled in a form to identify barriers to the diagnosis of narcolepsy. Phase 3: The panel produced suggestions for the implementation of Red Flags.Results: Red Flags were produced representing three clinical pictures of narcolepsy in pediatric patients ((1) usual sleep symptoms, (2) unusual sleep symptoms, (3) endocrinological signs) and two in adult patients ((1) usual sleep symptoms, (2) unusual sleep symptoms). Inadequate knowledge of symptoms at onset by medical doctors turned out to be the main reported barrier to diagnosis.Conclusions: This report will hopefully enhance knowledge and awareness of narcolepsy among non-specialists in sleep medicine in order to reduce the diagnostic delay that burdens patients in Italy. Similar initiatives could be promoted across Europe. [ABSTRACT FROM AUTHOR]

Background: The incidence of oral cancer is increasing. Guidance for oral cancer from the National Institute for Health and Care Excellence (NICE) is unique in recommending cross-primary care referral from GPs to dentists.Aim: This review investigates knowledge about delays in the diagnosis of symptomatic oral squamous cell carcinoma (OSCC) in primary care.Design and Setting: An independent multi-investigator literature search strategy and an analysis of study methodologies using a modified data extraction tool based on Aarhus checklist criteria relevant to primary care.Method: The authors conducted a focused systematic review involving document retrieval from five databases up to March 2018. Included were studies looking at OSCC diagnosis from when patients first accessed primary care up to referral, including length of delay and stage of disease at time of definitive diagnosis.Results: From 538 records, 16 articles were eligible for full-text review. In the UK, more than 55% of patients with OSCC were referred by their GP, and 44% by their dentist. Rates of prescribing between dentists and GPs were similar, and both had similar delays in referral, though one study found greater delays attributed to dentists as they had undertaken dental procedures. On average, patients had two to three consultations before referral. Less than 50% of studies described the primary care aspect of referral in detail. There was no information on inter-GP-dentist referrals.Conclusion: There is a need for primary care studies on OSCC diagnosis. There was no evidence that GPs performed less well than dentists, which calls into question the NICE cancer option to refer to dentists, particularly in the absence of robust auditable pathways. [ABSTRACT FROM AUTHOR]

Background: Surgeons' overload is one of the main causes of medical errors that might compromise patient safety. Due to the drawbacks of current options to monitor surgeons' load, new, sensitive, and objective indices of task (over)load need to be considered and tested. In non-health-care scenarios, intraocular pressure (IOP) has been proved to be an unbiased physiological index, sensitive to task complexity (one of the main variables related to overload), and time on task. In the present study, we assessed the effects of demanding and complex simulated surgical procedures on surgical and medical residents' IOP.Methods: Thirty-four surgical and medical residents and healthcare professionals took part in this study (the experimental group, N = 17, and the control group, N = 17, were matched for sex and age). The experimental group performed two simulated bronchoscopy procedures that differ in their levels of complexity. The control group mimicked the same hand-eye movements and posture of the experimental group to help control for the potential effects of time on task and re-measurement on IOP. We measured IOP before and after each procedure, surgical performance during procedures, and perceived task complexity.Results: IOP increased as consequence of performing the most complex procedure only in the experimental group. Consistently, residents performed worse and reported higher perceived task complexity for the more complex procedure.Conclusions: Our data show, for the first time, that IOP is sensitive to residents' task load, and it could be used as a new index to easily and rapidly assess task (over)load in healthcare scenarios. An arousal-based explanation is given to describe IOP variations due to task complexity. [ABSTRACT FROM AUTHOR]

Background: Most elderly trauma patients suffer blunt head injury and many utilize antithrombotic (AT) medications. The utility of delayed CT-head (D-CTH) in neurologically intact elderly patients using AT who have an intracranial hemorrhage (ICH) on presentation is unknown. We hypothesized that D-CTH would not alter clinical management and aimed to evaluate the role of D-CTH in this population.Methods: A retrospective cohort study was performed. Patients ≥65 years sustaining blunt head injuries from January 2010 to July 2017 were identified using our level 1 trauma center database. AT-patients presenting with ICH who underwent D-CTH were included. Patients with worsened ICH were compared to those with stable to improved ICH on D-CTH. AT-patients were compared to a cohort of non-AT patients. Fisher's Exact and Mann-Whitney U tests were utilized and a power analysis conducted.Results: 137 A T and 34 non-AT patients were identified. There was no difference in hemorrhage progression or appearance of new ICH. No patient had a change in management from D-CTH in either cohort. AT-patients were slightly older (p < 0.001), but cohorts were otherwise similar. 50 AT-patients with worsened ICH were compared to 87 with stable ICH. There was no difference in cohort demographics. Hemorrhage progression did not vary with type of AT used but did increase if multiple types of synchronous ICH were present (p < 0.001).Conclusions: Our data supports abstaining from routine D-CTH of elderly ICH patients with an intact neurologic examination who are utilizing aspirin, clopidogrel or warfarin. Conclusions cannot be drawn regarding new oral anticoagulants (NOACs) given low enrollment. Further multicenter study is required to provide adequate power and detect small levels of management change. [ABSTRACT FROM AUTHOR]

Currently used methods to express random error are often misinterpreted and consequently misused by biomedical researchers. Previously we proposed a simple approach to quantify the amount of random error in epidemiological studies using OR for binary exposures. Expressing random error with the number of random error units (REU) does not require solid background in statistics for a proper interpretation and cannot be misused for making oversimplistic interpretations relying on statistical significance. We now expand the use of REU to the most common measures of associations in epidemiology and to continuous variables, and we have developed a Stata program, which greatly facilitates the calculation of REU. [ABSTRACT FROM AUTHOR]

Objective: To analyze patient safety incidents (PSIs) reported by patients and their use in Finnish healthcare organizations.Study Design: Cross-sectional study.Setting: About 15 Finnish healthcare organizations ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland.Participants: The study population included all Finnish patients who had voluntarily reported PSI via web-based system in 2009-15.Main Outcome Measure(s): Quantitative analysis of patients' safety reports, inductive content analysis of patients' suggestions to prevent the reoccurrence incidents and how those suggestions were used in healthcare organizations.Results: Patients reported 656 PSIs, most of which were classified by the healthcare organizations' analysts as problems associated with information flow (32.6%) and medications (18%). Most of the incidents (65%) did not cause any harm to patients. About 76% of the reports suggested ways to prevent reoccurrence of PSIs, most of which were feasible, system-based amendments of processes for reviewing or administering treatment, anticipating risks or improving diligence in patient care. However, only 6% had led to practical implementation of corrective actions in the healthcare organizations.Conclusions: The results indicate that patients report diverse PSIs and suggest practical systems-based solutions to prevent their reoccurrence. However, patients' reports rarely lead to corrective actions documented in the registering system, indicating that there is substantial scope to improve utilization of patients' reports. There is also a need for strong patient safety management, including willingness and commitment of HCPs and leaders to learn from safety incidents. [ABSTRACT FROM AUTHOR]

Aims: This study examined delayed type one diabetes (T1D) diagnosis, along with the associated severity markers, in the United States. Qualitative reflection was explored to add depth of understanding.Methods: 975 parents of a minor child with T1D were recruited through snowball, social media requests to complete a 55-question online survey on the experience of diagnosis.Results: 34% of children with T1D had a delayed diagnosis. When compared to those without a delayed diagnosis, these children were more likely to have an Emergency Room diagnosis (39.8% vs. 24.6%), be transported by ambulance or life flight (30.7% vs. 15.3%), be hospitalized (93.7% vs. 83.9%), spend time in an Intensive Care Unit (42.2% vs. 21.3%), and be in diabetic ketoacidosis (DKA) (42.2% vs. 21.3%). Younger children were at increased risk, with higher rates of DKA and fewer days of symptoms. Many parents experienced frustration receiving a prompt diagnosis for their child, including an inability to schedule a physician appointment, proper glucose testing, and concerns being dismissed by professionals.Conclusion: More physician and parent education is needed. Doctors should conduct glucose screenings when diabetes symptoms are present. Parents need education to recognize excessive thirst and frequent urination as reasons to seek medical treatment. [ABSTRACT FROM AUTHOR]

Study Objective: The aim of this study is to provide a contemporary medicolegal analysis of claims brought against anesthesiologists in the United States for events occurring in the post-anesthesia care unit (PACU).Design: In this retrospective analysis, we analyzed closed claims data from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS) database.Setting: Claims closed between January 1, 2010 and December 31, 2014 were included for analysis if the alleged damaging event occurred in a PACU and anesthesiology was named as the primary responsible service.Patients: Forty-three claims were included for analysis. Data regarding ASA physical status and comorbidities were obtained, whenever available. Ages ranged from 18 to 94. Patients underwent a variety of surgical procedures. Severity of adverse outcomes ranged from temporary minor impairment to death.Interventions: Patients receiving care in the PACU.Measurements: Information gathered for this study includes patient demographic data, alleged injury type and severity, operating surgical specialty, contributing factors to the alleged damaging event, and case outcome. Some of these data were drawn directly from coded variables in the CRICO CBS database, and some were gathered by the authors from narrative case summaries.Results: Settlement payments were made in 48.8% of claims. A greater proportion of claims involving death resulted in payment compared to cases involving other types of injury (69% vs 37%, p = 0.04). Respiratory injuries (32.6% of cases), nerve injuries (16.3%), and airway injuries (11.6%) were common. Missed or delayed diagnoses in the PACU were cited as contributing factors in 56.3% of cases resulting in the death of a patient. Of all claims in this series, 48.8% involved orthopedic surgery.Conclusions: The immediate post-operative period entails significant risk for serious complications, particularly respiratory injury and complications of airway management. Appropriate monitoring of patients by responsible providers in the PACU is crucial to timely diagnosis of potentially severe complications, as missed and delayed diagnoses were a factor in a number of the cases reviewed. [ABSTRACT FROM AUTHOR]

Summary: In variational data assimilation a least‐squares objective function is minimised to obtain the most likely state of a dynamical system. This objective function combines observation and prior (or background) data weighted by their respective error statistics. In numerical weather prediction, data assimilation is used to estimate the current atmospheric state, which then serves as an initial condition for a forecast. New developments in the treatment of observation uncertainties have recently been shown to cause convergence problems for this least‐squares minimisation. This is important for operational numerical weather prediction centres due to the time constraints of producing regular forecasts. The condition number of the Hessian of the objective function can be used as a proxy to investigate the speed of convergence of the least‐squares minimisation. In this paper we develop novel theoretical bounds on the condition number of the Hessian. These new bounds depend on the minimum eigenvalue of the observation error covariance matrix and the ratio of background error variance to observation error variance. Numerical tests in a linear setting show that the location of observation measurements has an important effect on the condition number of the Hessian. We identify that the conditioning of the problem is related to the complex interactions between observation error covariance and background error covariance matrices. Increased understanding of the role of each constituent matrix in the conditioning of the Hessian will prove useful for informing the choice of correlated observation error covariance matrix and observation location, particularly for practical applications. [ABSTRACT FROM AUTHOR]

Introduction: We aimed to determine how serious adverse events in obstetrics were assessed by supervision authorities.Material and Methods: We selected cases investigated by supervision authorities during 2009-2013. We analyzed information about who reported the event, the outcomes of the mother and infant, and whether events resulted from errors at the individual or system level. We also assessed whether the injuries could have been avoided.Results: During the study period, there were 303 034 births in Norway, and supervision authorities investigated 338 adverse events in obstetric care. Of these, we studied 207 cases that involved a serious outcome for mother or infant. Five mothers (2.4%) and 88 infants (42.5%) died. Of the 207 events reported to the supervision authorities, patients or relatives reported 65.2%, hospitals reported 39.1%, and others reported 4.3%. In 8.7% of cases, events were reported by more than 1 source. The supervision authority assessments showed that 48.3% of the reported cases involved serious errors in the provision of health care, and a system error was the most common cause. We found that supervision authorities investigated significantly more events in small and medium-sized maternity units than in large units. Eighteen health personnel received reactions; 15 were given a warning, and 3 had their authority limited. We determined that 45.9% of the events were avoidable.Conclusions: The supervision authorities investigated 1 in 1000 births, mainly in response to complaints issued from patients or relatives. System errors were the most common cause of deficiencies in maternity care. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to identify factors associated with the occurrence of adverse events (AEs) or medical errors (MEs) during inpatient psychiatric hospitalizations.Methods: A full-probability random sample of 4,371 charts from 14 inpatient psychiatric units at acute care general hospitals in Pennsylvania were reviewed in a two-stage process that comprised screening and flagging by nurses followed by review by psychiatrists. AE and ME rates were calculated overall and then stratified by patient and hospital factors. Unadjusted and adjusted logistic regression models examined predictors of AEs and MEs.Results: An AE was identified in 14.5% of hospitalizations (95% confidence interval [CI]=11.7-17.9), and an ME was identified in 9.0% (CI=7.5-11.0). In adjusted analyses, patients with a longer length of stay and older patients had higher odds of experiencing an AE or an ME. Patients ages 31-42 (compared with ages 18-30), with commercial insurance (compared with Medicare or Medicaid or uninsured), or treated at high-volume hospitals (compared with low, medium, or very high) had lower odds of an AE. Patients age 54 or older (compared with ages 18-30), admitted during the weekend, admitted to rural hospitals (compared with urban), or treated at very-high-volume hospitals (compared with high) were more likely to experience an ME.Conclusions: This study provides insight into factors that put patients and hospitals at increased risk of patient safety events. This information can be used to tailor improvement strategies that enhance the safety of patients treated on general hospital psychiatric units. [ABSTRACT FROM AUTHOR]

Aim: Mineralocorticoid receptor antagonists (MRAs) improve outcomes in heart failure with reduced ejection fraction (HFrEF), but are underutilized. Hyperkalaemia may be one reason, but the underlying reasons for underuse are unknown. The aim of this study was to investigate the independent predictors of MRA underuse in a large and unselected HFrEF cohort.Methods and Results: We included patients with HFrEF (ejection fraction <40%), New York Heart Association (NYHA) class II-IV and heart failure (HF) duration ≥6 months from the Swedish HF Registry. Logistic regression analysis identified independent associations between 39 demographic, clinical, co-treatment, and socioeconomic predictors and MRA non-use. Of 11 215 patients, 27% were women; mean age was 75 ± 11 years; only 4443 (40%) patients received MRA. Selected characteristics independently associated with MRA non-use were in descending order of magnitude: lower creatinine clearance (<60 mL/min), no need for diuretics, no cardiac resynchronization therapy/implantable cardioverter-defibrillator, higher blood pressure, no digoxin use, higher ejection fraction, outpatient setting, older age, lower income, ischaemic heart disease, male sex, follow-up in primary vs. specialty care, lower NYHA class, and absence of hypertension diagnosis. Plasma potassium and N-terminal pro B-type natriuretic peptide levels were not associated with MRA non-use.Conclusion: Mineralocorticoid receptor antagonists remain underused in HFrEF. Their use does not decrease with elevated potassium but does with impaired renal function, even in the creatinine clearance 30-59.9 mL/min range where MRAs are not contraindicated. MRA underuse may be further related to non-specialist care, milder HF and no use of other HF therapy. [ABSTRACT FROM AUTHOR]

We studied the occurrence of adverse events (AEs) in low-risk non-survivors (LNs), compared to low-risk survivors (LSs), high-risk non-survivors (HNs), and high-risk survivors (HSs) in two pediatric intensive care units (PICUs). The study was performed as a retrospective patient record review study, using a PICU-trigger tool. A random sample of 48 PICU patients (0-18 years) was chosen, stratified into four subgroups of 12 patients: LNs, LSs, HNs, and HSs. Primary outcome was the occurrence of AEs. The severity, preventability, and nature of the indentified AEs were determined. In total, 45 AEs were found in 20 patients. The occurrence of AEs in the LN group was significantly higher compared to that in the LS group and HN group (AE occurrence: LN 10/12 patients, LS 1/12 patients; HN 2/12 patients; HS 7/12 patients; LN-LS difference, p < 0.001; LN-HN difference, p < 0.01). The AE rate in the LN group was significantly higher compared to that in the LS and HN groups (median [IQR]: LN 0.12 [0.07-0.29], LS 0 [0-0], HN 0 [0-0], and HS 0.03 [0.0-0.17] AE/PICU day; LN-LS difference, p < 0.001; LN-HN difference, p < 0.01). The distribution of the AEs among the four groups was as follows: 25 AEs (LN), 2 AEs (LS), 8 AEs (HN), and 10 AEs (HS). Fifteen of forty-five AEs were preventable. In 2/12 LN patients, death occurred after a preventable AE.Conclusion: The occurrence of AEs in LNs was higher compared to that in LSs and HNs. Some AEs were severe and preventable and contributed to mortality. What is Known: • 59-76% of all PICU patients encounter at least one adverse event during their PICU stay. • It is unknown if adverse events play a role in death of low-risk PICU patients. What is New: • In low-risk PICU non-survivors, occurrence of adverse events is higher compared to low-risk PICU survivors and to high-risk PICU non-survivors. • Severe and preventable adverse events occur in low-risk PICU non-survivors, some contributing to mortality. [ABSTRACT FROM AUTHOR]

Objective: Trauma is the leading cause of non-obstetrical causes of death in pregnant patients. The use of radiographic imaging for evaluation in the trauma bay is a controversial topic. However, in some cases the benefits of using radiographic imaging to ensure maternal survival outweigh the risks of radiation exposure to the fetus. This study explores whether sparing fetal exposure to radiation by minimizing use of ionizing radiographic imaging to the mother will put the mother at risk for a delayed diagnosis of injury. We hypothesize that minimizing the use of radiographic imaging in the initial assessment of pregnant trauma patients does not lead to a higher incidence of delayed diagnosis.Study Design: A retrospective chart review at an urban level 1 trauma center reviewing pregnant patients involved in blunt trauma and a cohort of non-pregnant patients matched for age and ISS. Data points included: number and type of imaging studies performed on initial presentation and the number and type of imaging studies that were delayed. The primary outcome was incidence of delayed diagnosis in the pregnant trauma patient compared to the non-pregnant patient.Results: 83 pregnant and 167 non-pregnant patients were examined. Average average ISS was 2.7 in both groups. 95.2% of the pregnant population had at least one imaging study done versus 100% of the control group (p = 0.004). The pregnant population had an average of 4.3 images performed compared with an average of 6.8 images in the non-pregnant cohort (p=<0.001). 18 (21.7%) pregnant patients had delayed imaging and 58 (34.7%) control patients had delayed imaging (p = 0.03). This led to an incidence of delayed diagnosis in 1% of pregnant patients and 5% control patients (p = 0.17).Conclusion: Our study shows that bluntly injured pregnant trauma patients receive significantly fewer radiographic images upon presentation than their non-pregnant counterparts. However, this led to insignificant difference in delay of injury diagnosis between pregnant and non-pregnant patients when matched for age and ISS. Though the ISS was low for both patient cohorts, this study suggests that mitigated radiographic imaging in the pregnant trauma patient is safe and does not result in delayed diagnosis of injury. [ABSTRACT FROM AUTHOR]

Purpose: Chemoradiation therapy trials of different tumors, including lung cancer, have shown a correlation between protocol deviations and adverse outcomes. Radiation therapy quality assurance (RTQA) was mandated for all patients treated in the PROCLAIM trial evaluating 2 different chemoradiation therapy regimens. The RTQA results were evaluated from the PROCLAIM study, and the impact of irradiation deviations on efficacy outcomes was investigated.Methods and Materials: The study was conducted from 2008 to 2014. Review of the irradiation plan was mandated for all patients. Real-time review was performed prior to irradiation start for the first enrolled patient at each site and randomly in 20% of additional patients, with non-real-time review in the remainder. The RTQA criteria evaluated included planning target volume coverage, dose homogeneity, volume of lung receiving ≥20 Gy, and maximum point dose to spinal cord.Results: Major RTQA violations occurred in 40 of 554 patients, treated at 28 sites. Seven sites treated ≥2 patients with major violations. Stage IIIB disease and larger planning target volume were observed more frequently in patients with major violations. Major violations were more prevalent in sites treating either <6 patients or >15 patients. Patients treated at sites enrolling ≥2 patients with major violations (n = 86) had lower median overall survival (21.1 months vs 29.8 months; hazard ratio, 1.442) and progression-free survival (7.3 months vs 11.3 months; hazard ratio, 1.345) than patients treated at sites without major violations. These findings remained significant for overall survival on multivariate analysis.Conclusions: Major violations in treatment plans were uncommon in the PROCLAIM study, possibly reflecting mandatory RTQA. The RTQA violations were more frequent in patients requiring more complex chemoradiation therapy plans. Poorer observed outcomes at centers with multiple major violations are hypothesis generating. [ABSTRACT FROM AUTHOR]

Objective: To assess the prevalence of adverse events (AE) and to investigate its association with factors related to the patient and to hospital admission.Design: Cross-sectional study.Setting: Four general hospitals located in the southeastern region of Brazil.Participants: All patients admitted to the participating hospitals at the time of the study were surveyed.Intervention: The methodology was based on the Iberoamerican study of adverse events, a two-stage medical record review.Main Outcome Measure: Medical records were screened for AE only in the day (24-h) immediately before the review process, independently of the admission date.Results: A total of 695 admissions were examined. Prevalence was 12.8%. Almost 43% of AE were preventable. More than 60% of patients with an event prolonged hospital stay. In final regression model, urgent admission (OR: 2.68; Confidence Interval (CI) 95%: 1.53-4.69), submission to a procedure (odds ratio (OR): 2.41; CI 95%: 1.33-4.39), presence of central venous catheter (OR: 2.25; CI 95%: 1.14-4.41) and immunosuppressive therapy (OR: 3.41; CI 95%: 1.57-7.40) were statistically associated with AE.Conclusions: Our results indicate that around 1.3 AE happen in each 10 hospital admissions in Brazil. As patient safety continues to be a Public Health concern worldwide and mainly in developing countries, this would indicate the potential use of prevalence measures for monitoring patient safety in Brazilian context. [ABSTRACT FROM AUTHOR]

Background: Breast cancer is the most common malignancy encountered during pregnancy. However, the burden of pregnancy-associated breast cancer (PABC) and subsequent care is understudied in sub-Saharan Africa (SSA). Here, we describe the characteristics, diagnostic delays and treatment of women with PABC seeking care at a rural cancer referral facility in Rwanda.Methods: Data from female patients aged 18-50 years with pathologically confirmed breast cancer who presented for treatment between July 1, 2012 and February 28, 2014 were retrospectively reviewed. PABC was defined as breast cancer diagnosed in a woman who was pregnant or breastfeeding. Numbers and frequencies are reported for demographic and diagnostic delay variables and Wilcoxon rank sum and Fisher's exact tests are used to compare characteristics of women with PABC to women with non-PABC at the alpha = 0.05 significance level. Treatment and outcomes are described for women with PABC only.Results: Of the 117 women with breast cancer, 12 (10.3%) had PABC based on medical record review. The only significant demographic differences were that women with PABC were younger (p = 0.006) and more likely to be married (p = 0.035) compared to women with non-PABC. There were no significant differences in diagnostic delays or stage at diagnosis between women with PABC and women with non-PABC women. Eleven of the women with PABC received treatment, three had documented treatment delays or modifications due to their pregnancy or breastfeeding, and four stopped breastfeeding to initiate treatment. At the end of the study period, six patients were alive, three were deceased and three patients were lost to follow-up.Conclusions: PABC was relatively common in our cohort but may have been underreported. Although patients with PABC did not experience greater diagnostic delays, most had treatment modifications, emphasizing the potential value of PABC-specific treatment protocols in SSA. Larger prospective studies of PABC are needed to better understand particular challenges faced by these patients and inform policies and practices to optimize care for women with PABC in Rwanda and similar settings. [ABSTRACT FROM AUTHOR]

Study Objective: Wrong-site nerve blocks (WSBs) are a significant, though rare, source of perioperative morbidity. WSBs constitute the most common type of perioperative wrong-site procedure reported to the Pennsylvania Patient Safety Authority. This systematic literature review aggregates information about the incidence, patient consequences, and conditions that contribute to WSBs, as well as evidence-based methods to prevent them.Design: A systematic search of English-language publications was performed, using the PRISMA process.Main Results: Seventy English-language publications were identified. Analysis of four publications reporting on at least 10,000 blocks provides a rate of 0.52 to 5.07 WSB per 10,000 blocks, unilateral blocks, or "at risk" procedures. The most commonly mentioned potential consequence was local anesthetic toxicity. The most commonly mentioned contributory factors were time pressure, personnel factors, and lack of site-mark visibility (including no site mark placed). Components of the block process that were addressed include preoperative nerve-block verification, nerve-block site marking, time-outs, and the healthcare facility's structure and culture of safety.Discussion: A lack of uniform reporting criteria and divergence in the data and theories presented may reflect the variety of circumstances affecting when and how nerve blocks are performed, as well as the infrequency of a WSB. However, multiple authors suggest three procedural steps that may help to prevent WSBs: (1) verify the nerve-block procedure using multiple sources of information, including the patient; (2) identify the nerve-block site with a visible mark; and (3) perform time-outs immediately prior to injection or instillation of the anesthetic. Hospitals, ambulatory surgical centers, and anesthesiology practices should consider creating site-verification processes with clinician input and support to develop sustainable WSB-prevention practices. [ABSTRACT FROM AUTHOR]

Background: All humans are fallible. Because physicians are human, unintentional errors unfortunately occur. While unintentional medical errors have an impact on patients and their families, they may also contribute to adverse mental and emotional effects on the involved provider(s). These may include burnout, lack of concentration, poor work performance, posttraumatic stress disorder, depression, and even suicidality.Objectives: The objectives of this article are to 1) discuss the impact medical error has on involved provider(s), 2) provide potential reasons why medical error can have a negative impact on provider mental health, and 3) suggest solutions for providers and health care organizations to recognize and mitigate the adverse effects medical error has on providers.Discussion: Physicians and other providers may feel a variety of adverse emotions after medical error, including guilt, shame, anxiety, fear, and depression. It is thought that the pervasive culture of perfectionism and individual blame in medicine plays a considerable role toward these negative effects. In addition, studies have found that despite physicians' desire for support after medical error, many physicians feel a lack of personal and administrative support. This may further contribute to poor emotional well-being. Potential solutions in the literature are proposed, including provider counseling, learning from mistakes without fear of punishment, discussing mistakes with others, focusing on the system versus the individual, and emphasizing provider wellness. Much of the reviewed literature is limited in terms of an emergency medicine focus or even regarding physicians in general. In addition, most studies are survey- or interview-based, which limits objectivity. While additional, more objective research is needed in terms of mitigating the effects of error on physicians, this review may help provide insight and support for those who feel alone in their attempt to heal after being involved in an adverse medical event.Conclusions: Unintentional medical error will likely always be a part of the medical system. However, by focusing on provider as well as patient health, we may be able to foster resilience in providers and improve care for patients in healthy, safe, and constructive environments. [ABSTRACT FROM AUTHOR]

Introduction: The intoxicated person may cause harm to others, often requiring expert evaluation for the determination of guilt. The primary aim of this study was to determine the mechanisms of mistakes that led 17 doctors accused of working under the influence of alcohol to face malpractice. We also wanted to clarify what were the legal, professional, and financial consequences - depending on specific patient outcomes.Method: We based analysis on the review and meta-analysis of the past forensic evaluation reports of institution-run forensics programs. Furthermore, we apply thematic analysis using combination of grounded theory and Pierre Bourdieu's theoretical framework.Results: During the 2010-2016 timeframe, the regional forensic service opinionated on 17 physicians (3F, 14M) subjected to disciplinary action due to providing treatment under the influence of alcohol. In total, there were 157 patients potentially affected by malpractice - out of those, four were harmed; only one qualified for compensation. In the remaining 153 patients - only 11 persons reported having had awareness about the doctors' intoxication and apparent inability to perform the job, yet they agreed to receive care. Overall, in over 90% of patients, the physician did not harm anyone to a degree threatening patient's life. The supporting staff did not report experiencing distress either. The results of a blood test for the presence of alcohol were available for only four cases. Therefore, it was impossible to analyze the correlation between intoxication level and performance in providing care. All in all, in our analysis - less than 10% of 157 patients' care were compromised by provider's intoxication, either due to a mistake in diagnosis, medical procedure, or lacking communication skills.Conclusion: For physicians, working under the influence of alcohol is an uncommon phenomenon, but when it occurs - patients are at risk for receiving poor treatment. Presented analysis indicates that patients - just as much as supporting staff - frequently agree to receive supervision and care from a drunk doctor, despite possible harm. Therefore, it is evident that patients as much as supporting staff fear retaliation, leading to underreporting of these cases. [ABSTRACT FROM AUTHOR]

We conducted an online survey to assess the career experiences of wrong side blocks, the practice of Stop-Before-You-Block, the recently described method of Mock-Before-You-Block and attitudes to these. Respondents were 208 anaesthetists across nine hospitals (173 consultants or Staff and Associate Specialist doctors'), representing 3623 years of collective anaesthetic practice. There had been a total of 62 wrong side blocks (by 51 anaesthetists and one current trainee). Predisposing factors for this were commonly ascribed to distractions (35 (69%), for example due to rushing or teaching), patient positioning (9 (18%)) or miscommunication (6 (12%)). Two (4%) respondents felt they had performed Stop-Before-You-Block too early; 62 (41%) of all respondents stated they performed Stop-Before-You-Block as early as preparing the skin or on arrival of the patient in the anaesthetic room, and not any later. Twenty (10%) respondents admitted to not performing Stop-Before-You-Block at all or only occasionally (including 5 (2%) who had performed a wrong side block). Mock-Before-You-Block was easily understood (by 169 out of 197 (86%)) and 14 out of 61 (23%) respondents felt it would have prevented the wrong side error in their case. However, free-text comments indicated that many anaesthetists were reluctant to use a method that interrupted their performance of the block. We conclude that considerable work is needed to achieve full compliance with Stop-Before-You-Block at the correct time. [ABSTRACT FROM AUTHOR]

Objectives: To determine time to diagnosis in a paediatric inflammatory bowel disease (IBD) cohort and the relative contribution of the component intervals, and to identify factors associated with diagnostic delay.Design: Prospective cohort study SETTING: Single-centre study including children with incident IBD at the Hospital for Sick Children diagnosed between December 2013 and December 2015.Interventions: Time to diagnosis and its subintervals were determined and patient, disease and institutional factors were tested for associations.Results: Among 111 children, the median overall time to diagnosis was 4.5 (IQR 2.1-8.8) months. Time to diagnosis was longer in Crohn's disease (CD) than ulcerative colitis (UC) (median 6.8 (IQR 2.9-12.5) vs 2.4 (IQR 1.3-5.3) months) and patients with isolated small bowel disease. Twenty per cent of patients were diagnosed≥1 year after symptom onset (86% CD, 14% UC, p=0.003). Time from symptom onset to gastroenterology referral was the greatest contributor to overall time to diagnosis (median 2.9 (IQR 1.6-8.2) months). Height impairment was independently associated with diagnostic delay (OR 0.59, p=0.02, for height-for-age z-score (HAZ), signifying almost 70% increased odds of delay for every 1 SD decrease in HAZ). This height discrepancy persisted 1 year after diagnosis. Bloody diarrhoea was protective against delay (OR 0.28, p=0.02). The subinterval from referral to diagnosis was shorter in patients with laboratory abnormalities, particularly hypoalbuminaemia.Conclusions: Diagnostic delay was more common in CD and associated with height impairment that persisted 1 year after presentation. The greatest contributor to time to diagnosis was time from symptom onset to referral. [ABSTRACT FROM AUTHOR]

Time of admission and surgeon experience may explain variations in trauma outcomes. We hypothesized that earlier admission time by a more experienced trauma surgeon leads to improved outcomes after injury. We conducted a retrospective cohort study using trauma registry and performance improvement data at our Level 1 trauma center. Consecutive patients presenting at night from 2013 to 2014 were dichotomized into early (6:00 pm-12:00 am) and late (12:01 am-7:00 am) cohorts. Second year trauma fellows acting as attendings and staff trauma surgeons were categorized as less and more experienced, respectively. The primary study outcome was any complication tracked by our state registry, missed injury, delay in diagnosis, or death. The influence of admission time and trauma surgeon experience on this endpoint was examined using multivariable logistic regression. A total of 2078 patients presented either during early (n = 1189) or late (n = 889) night. The cohorts were not different with respect to Deyo-Charlson index, systolic blood pressure, Glasgow Coma Scale, Injury Severity Core, admitting trauma surgeon age, experience, or unadjusted primary study outcome (early 14 vs late 16%; P = 0.206). Trauma surgeon experience was independently predictive of outcomes. Trauma patients admitted at night by fellows were 29 per cent less likely to sustain complications or death than those admitted by staff (adjusted odds ratio 0.71; 95% confidence interval: 0.54-0.92, P = 0.010). This protective effect of fellow care was found only in patients admitted after midnight (P = 0.03). In conclusion, nighttime initial trauma care by fellows was associated with improved outcomes. Possible explanations include more oversight of nighttime fellow care, variations in daytime responsibilities between fellows and staff, and differential effects of sleep loss by age. [ABSTRACT FROM AUTHOR]

Objective: Complex medical devices such as infusion pumps are increasingly being used in patients' homes with little known about the impact on patient safety. Our aim was to better understand the risks to patient safety in this situation and how these risks might be minimised, by reference to incident reports.Design: We identified 606 records of incidents associated with infusion devices that had occurred in a private home and were reported to the UK National Reporting and Learning Service (2005-2015 inclusive). We used thematic analysis to identify key themes.Results: In this paper we focus on two emergent themes: detecting and diagnosing incidents; and locating the patient, lay caregivers and their family in incident reports. The majority of incidents were attributed to device malfunction, and resulted in the patient being under-dosed. Delays in recognising and responding to problems were identified, alongside challenges in identifying the cause. We propose a process model for fault diagnosis and correction. Patients and caregivers did not feature strongly in reports; we highlight how the device is in the home but of the care system, and propose an agent model to describe this; we also identify ways of mitigating this disjoint.Conclusion: Devices need to be appropriately tailored to the setting in which they are employed, and within a system of care that ensures they are used optimally and safely. Suggested features to improve patient safety include devices that can provide better feedback to identify problems and support resolution, alongside greater monitoring and technical support by care providers for both patients and frontline professionals. The proposed process and agent models provide a structure for reviewing safety and learning from incidents in home health care. [ABSTRACT FROM AUTHOR]

Objectives: To determine the average time in months between the beginning of symptoms and the diagnostic confirmation of leprosy by the health system and to investigate factors associated with diagnostic delay.Methods: A total of 249 patients older than 15 years diagnosed with leprosy between 2011 and 2015, in 20 endemic municipalities of north-eastern Colombia, provided informed consent and were interviewed face-to-face. Clinical histories from health centres or hospitals where study participants were treated for leprosy were also reviewed.Results: The mean delay in diagnosis of leprosy was 33.5 months. About 14.9% of patients showed a visible deformity or damage (disability grade 2, DG2) at the time of diagnosis. In multivariable regression analysis, five or more consultancies required to confirm the diagnosis and not seeking care immediately after noticing first symptoms were associated with longer diagnostic delay.Conclusions: Our study found a significant delay in diagnosis of leprosy in north-eastern Colombia, which might explain the continuously high rate of DG2 among new cases being notified in the country. Both patient- and health system-related factors were associated with longer diagnostic delay. Interventions to increase awareness of disease among the general population and timely referral to a specialised health professional are urgently needed in our study setting. [ABSTRACT FROM AUTHOR]

Background: Tuberculosis (TB) is a serious health concern, particularly in developing countries. Various delays, such as patient delay (PD) and healthcare system delay (HSD) in the TB process, are exacerbating the disease burden and increasing the rates of transmission and mortality in various global communities. Therefore, the aim of this study is to identify risk factors associated with PD and HSD in TB patients in Tabriz, Iran.Methods: A cross-sectional study was conducted on 173 TB patients in Tabriz, Iran from 2012 to 2014. Patients were interviewed with a semi-structured questionnaire. Frequencies and percentages were reported for patient categories of sex, age, and education. The median and interquartile range (IQR) were reported for the time intervals of delays. Univariate and multivariate logistic regressions of delay in respect to socio-demographic and clinical variables were performed. Statistical significance was set at p < 0.05.Results: The median values for delays were 53 days for HSD (IQR = 73) and 13 days for PD (IQR = 57). Odds ratios (OR) associated with PD were: employed vs. unemployed (OR = 5.86, 95% CI: 1.59 to 21.64); public hospitals vs. private hospitals (OR = 2.64, 95% CI: 1.01 to 6.85); ≥ 3 vs. < 3 visits to health facilities before correct diagnosis (OR = 2.35, 95% CI: 1.08 to 5.11); and male vs. female (OR = 2.28, 95% CI: 1.29 to 4.39). The OR associated with HSD were: ≥ 3 vs. < 3 visits to health facilities before correct diagnosis (OR = 9.44, 95% CI: 4.50 to 19.82), without vs. with access to TB diagnostic services (OR = 3.56, 95% CI: 1.85 to 6.83), and misdiagnosis as cold or viral infection vs. not (OR = 2.62, 95% CI: 1.40 to 4.91).Conclusions: The results provide for an important understanding of the risk factors associated with PD and HSD. One of the major recommendations is to provide more TB diagnostic knowledge and tools to primary health providers and correct diagnoses for patients during their initial visit to the health care facilities. The knowledge generated from this study will be helpful for prioritizing and developing strategies for minimizing delays, initiating early treatment to TB patients, and improving TB-related training programs and healthcare systems in Tabriz, Iran. [ABSTRACT FROM AUTHOR]

Background: Endoscopic biliary stenting is a common procedure in routine gastroenterology practice. Plastic stents are the most common type of stents used and are indicated mainly for short-term biliary drainage. Prolonged indwelling plastic stents can result in disastrous complications.Methods: We conducted a retrospective analysis of patients who presented with complications of forgotten biliary stents in a tertiary care hospital during January 2010 to October 2016. All patients were managed either by endoscopic or surgical means. Details of these patients were obtained from departmental patient database, endoscopy records, and surgical register.Results: A total of 21 cases of retained biliary stents were managed in the study period and their outcome was analyzed. The median age was 47 years (range 17-70 years) and 17 (80.9%) patients were female. Primary indication of biliary stenting was stone disease in 76.2% (n = 16), while benign biliary stricture accounted for 19% of cases (n = 4). Mean duration at presentation to hospital after ERCP stenting was 3.53 years (range 1-14 years), with cholangitis being the most common presentation (66.67%). Definitive endoscopic treatment for forgotten stent and its associated complication was possible only in five patients (23.8%); in remaining 16 (76.2%) cases, surgical exploration was required. Despite life-threatening complications and major surgical interventions, no mortality was recorded.Conclusions: Instances of forgotten biliary stents presenting with serious complications are not uncommon in Indian setup. Patients either ignore advice for timely stent removal or are unaware of the presence of endoprosthesis or need for removal. Adequate patient counseling, information, and proper documentation are essential to avoid this condition. [ABSTRACT FROM AUTHOR]

Sample size estimation for comparing the rates of change in two-arm repeated measurements has been investigated by many investigators. In contrast, the literature has paid relatively less attention to sample size estimation for studies with multi-arm repeated measurements where the design and data analysis can be more complex than two-arm trials. For continuous outcomes, Jung and Ahn (2004) and Zhang and Ahn (2013) have presented sample size formulas to compare the rates of change and time-averaged responses in multi-arm trials, using the generalized estimating equation (GEE) approach. To our knowledge, there has been no corresponding development for multi-arm trials with count outcomes. We present a sample size formula for comparing the rates of change in multi-arm repeated count outcomes using the GEE approach that accommodates various correlation structures, missing data patterns, and unbalanced designs. We conduct simulation studies to assess the performance of the proposed sample size formula under a wide range of designing configurations. Simulation results suggest that empirical type I error and power are maintained close to their nominal levels. The proposed method is illustrated using an epileptic clinical trial example. [ABSTRACT FROM PUBLISHER]

Background: Air Force Critical Care Air Transport Teams (CCATTs) provide fixed-wing aeromedical evacuation for combat casualties. Multiple studies have evaluated CCATT trauma patients; however, nearly 50% of patients medically evacuated from combat theaters are for nontraumatic medical illnesses to include stroke, myocardial infarctions, overdose, and pulmonary emboli. Published data are limited regarding illness types, in-flight procedures, and adverse events.Objective: The objective of our study was to characterize patients with nontraumatic medical illnesses transferred via CCATT to include a description of in-flight procedures and events.Study Design: We performed a retrospective review of CCATT medical records of patients with nontraumatic medical illnesses transported via CCATT from theater of operations to Landstuhl Regional Medical Center between January 2007 and April 2015. We abstracted data from CCATT records to include demographics, description of current illness, vital signs, labs, in-flight procedures and medications, and in-flight adverse events. Following descriptive analysis, comparative tests were performed based on service status of patients and primary diagnoses.Results: We reviewed 672 records of critically ill medical patients transported via CCATT, most of whom were male (90%, n = 606). Approximately 56% of the patients were U.S. active duty members; the remainder included U.S. contractors and civilians, and foreign citizens or unknown. The three categories (active duty, contractor/civilian, foreign/unknown) significantly differed from one another in age. Over half of the patients received a primary or secondary cardiac diagnosis. The most common in-flight procedures and medications included supplementary oxygenation, anticoagulant/antiplatelet medications, analgesics, and ventilation. Up to 20% of patients required continuous medication infusions other than analgesics. Patients most frequently experienced in-flight complications related to their primary diagnoses.Conclusions: Fifty-six percent (672) of 1,209 CCATT records that were queried were of patients with medical conditions. The most common primary diagnoses of CCATT medical patients were cardiac, pulmonary, and neurological in etiology. Mechanical ventilation and continuous medication infusions were required in approximately 20% of patients. The data provided by this study may assist in guiding future CCATT training requirements and resource allocation, as well as clinical practice guideline development. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this article is to determine whether some of the urgent (<24 hours) medical evacuations (MEDEVACs) (from French Navy surface ships in isolated situations but with an embarked medical officer) of patients suffering from minor surgical emergencies could have been avoided, and if so, which ones.Materials and Methods: This was a retrospective descriptive study of all MEDEVAC's performed between 2009 and 2014. This was done by an analysis of the records held at the French Naval Medical Headquarters that included both MEDEVAC signals and anonymized files called "Patient Movement Request."Results: 560 MEDEVACs were performed from French Navy surface ships which most had an embarked medical officer but which were in isolated situations. Only 34 (6.1%) of the total evacuations were suffering from minor surgical emergencies. The majority of these were nonurgent MEDEVAC's of whom 17 (50%) had no surgical procedure attempted on board. Seven (20%) underwent urgent MEDEVAC and only 2 of them had undergone the indicated therapeutic procedure on board. The most common pathology was displaced fracture of the fifth metacarpal (29.4%) before deep abscess (17.6%).Conclusion: Contrary to our initial expectation, the operational impact of minor surgical emergencies remains low, which might suggest that a French naval medical doctor's training is sufficient in this particular field. However, 50% of the overall evacuated patients and 71% of the "urgent" MEDEVACs (<24 hours) did not undergo the indicated, simple surgical procedure before evacuation. The idea of introducing a specific training program for these procedures may therefore still have value. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of our study is to investigate the delay in diagnosis of patients with biopsy-proven celiac disease in those who present with gastrointestinal complaints vs nongastrointestinal complaints at our tertiary care center. Celiac disease is an autoimmune disorder that affects approximately 1% of the population worldwide. Celiac disease can have variable clinical presentations; it can be characterized by predominately gastrointestinal symptoms, or it may present without any gastrointestinal symptoms.Methods: We retrospectively reviewed the charts of 687 adult patients who carried the diagnosis of celiac disease. Patients included had biopsy-proven celiac disease and were categorized based on presence or absence of gastrointestinal symptoms prior to their diagnosis.Results: There were 101 patients with biopsy-proven celiac disease that met inclusion criteria. Fifty-two patients presented with gastrointestinal symptoms and 49 had nongastrointestinal complaints. Results from Mann-Whitney statistical analysis showed a median delay in diagnosis of 2.3 months for the gastrointestinal symptoms group and 42 months for the nongastrointestinal group (P <.001); 43.2% of patients with nongastrointestinal symptoms had abnormal thyroid-stimulating hormone, as opposed to 15.5% in the gastrointestinal symptom group (P = .004). Of patients with nongastrointestinal symptoms, 69.4% had anemia, compared with 11.5% of the gastrointestinal symptom group (P <.001). The majority of patients in the nongastrointestinal symptom group, 68%, were noted to have abnormal bone density scans, compared with 41% in the gastrointestinal symptom group. No sex differences were noted on chi-squared analysis between the 2 groups (P = .997).Conclusions: Although there is growing awareness of celiac disease, the delay in diagnosis for patients without gastrointestinal symptoms remains prolonged, with an average delay of 3.5 years. [ABSTRACT FROM AUTHOR]