Unintended Events Research Articles

LO91: Repeat exposures to culprit drugs contribute to adverse drug events in emergency department patients

Introduction: Adverse drug events (ADEs), unintended and harmful events associated with medications, cause or contribute to 2 million annual emergency department (ED) visits in Canada. Australian data indicate that 27% of ADEs requiring admission are events caused by re-exposure to drugs that previously caused harm. Our objective was to estimate the frequency of repeat ADEs. Methods: We reviewed the charts of ADE patients who had been enrolled in 1 of 3 prospective studies conducted in 2 tertiary care and 1 urban community ED. In the parent studies, researchers enrolled patients by applying a systematic selection algorithm to minimize selection bias, and physicians and pharmacists evaluated patients prospectively to evaluate the causal association between the drug regimens and patient presentations. After completion of the parent studies, a research pharmacist and a physician independently reviewed the charts of ADE patients, abstracted data using electronic forms, and searched that hospital’s records for previously recorded ADEs. The main outcome was a repeat ADE, defined as a same or same-class drug re-exposure, or repeat inappropriate drug withdrawal, causing a same or similar presentation as a prior ADE. Sample size was based on enrolment into the parent studies. Results: We reviewed the charts of 614 ED patients diagnosed with 655 ADEs. Of these, 20% (133/665, 95%CI 17.0-23.0%) were repeat events. Most repeat ADEs were moderate (61%) or severe (32%) in nature, and 33% (95%CI 25.1-41.1%) required hospital admission. The most commonly implicated drugs were warfarin (10%), hydrochlorothiazide (4%) and insulin (4%), and the most commonly implicated drug classes were antithrombotics (17%), psychotropics (12%) and analgesics (9%). Repeat ADEs commonly required clinical monitoring (59%), additional medications to treat the ADE (50%) and follow-up lab testing (35%). Overall, 61% (95%CI 51.3-70.7%) of culprit drug re-exposures were deemed potentially or definitely inappropriate. Conclusion: Inappropriate re-exposures to previously harmful medications cause a substantial number of recurrent ADEs, and may represent an ideal target for prevention. We were unable to search for repeat ADEs in the records of other hospitals that our patients may have visited, and could not detect ADEs that were not documented in the medical record. As a result, we likely underestimated the frequency of repeat ADEs.

LO92: Factors contributing to the development of adverse drug events treated in emergency departments

Introduction: Adverse drug events (ADEs), unintended and harmful events associated with medications, commonly cause or contribute to emergency department (ED) presentations. Understanding provider, patient and system factors that contribute to their development may assist in developing effective preventative strategies. Our objective was to identify factors that contributed to the development of ADEs that caused ED presentations. Methods: We reviewed the charts of ADE patients enrolled in 1 of 3 prospective studies conducted in 3 tertiary care and 1 urban community ED. In the parent studies, researchers enrolled patients by applying a systematic selection algorithm to minimize selection bias, and physicians and pharmacists evaluated patients prospectively to evaluate the causal associations between the drug regimens and patient presentations. Subsequently, a research pharmacist and physician independently reviewed the charts of ADE patients from these cohorts, abstracting data using electronic forms. Reviewers recorded patient, provider and system factors that contributed to the development of ADEs. The main outcome was the presence of at least one contributing factor in the development of an ADE. We used descriptive statistics with appropriate measures of variance. The sample size was determined by enrolment into the primary studies. Results: We reviewed the charts of 670 patients diagnosed with 725 ADEs. We identified ≥1 contributing factors in 62% (95%CI 58-65%) of ADEs. Multiple contributing factors were present in 17% of ADEs (95%CI 13-20%). The most common contributing factors were inadequate patient counseling or instructions about medication use (15%), insufficient laboratory monitoring or follow-up of monitoring tests (12%), lack of staff education (7%), lack of provider adherence with recommended treatment guidelines (7%), and delayed or inadequate clinical reassessment after a medication change (6%). Provider errors in drug administration contributed to 0.3% of ADEs (95%CI 0.0-0.7). Conclusion: Contributing factors were identified for most ADEs. They were often related to inadequate counseling and follow-up, and were rarely the result of errors. Further research is required to understand how communication of medication instructions can be improved. Investments in technologies to reduce provider errors may not significantly reduce the numbers of ADE patients presenting to EDs.

A brief psychological intervention to reduce repetition of self-harm in patients admitted to hospital following a suicide attempt: a randomised controlled trial

SummaryBackgroundWe investigated whether a volitional helpsheet (VHS), a brief psychological intervention, could reduce repeat self-harm in the 6 months following a suicide attempt.MethodsWe did a prospective, single-site, randomised controlled trial. Patients admitted to a hospital in Edinburgh, UK, after a suicide attempt were deemed eligible for the study if they were over the age of 16 years, had a self-reported history of self-harm, were fluent in English, were medically fit to interview, and were not participating in other research studies within the hospital. Eligible patients were randomly assigned (1:1), via web-based randomisation, to receive either VHS plus usual treatment (intervention group) or only treatment as usual (control group). Randomisation was stratified by sex and self-reported past self-harm history. The Information Services Division of the National Health Service (NHS-ISD) staff and those extracting data from medical notes were masked to the study group the participant was allocated to. Clinical staff working within the hospital were also masked to participants' randomisation status. There were three primary outcomes: the proportion of paticipants who re-presented to hospital with self-harm during the 6-month follow-up period; the number of times a participant re-presented to hospital with self-harm during the 6-month follow-up period; and cost-effectiveness of the VHS as measured by estimated incremental cost per self-harm event averted. Primary outcomes were analysed in all randomised patients. Follow-up data collection was extracted from the Information Services Division of the NHS and from patient medical records. The trial is registered with International Standard Randomised Controlled Trial Number Registry, number ISRCTN99488269.FindingsBetween May 9, 2012, and Feb 24, 2014, we assessed 1308 people for eligibility. Of these, 259 patients were randomly assigned to the intervention group and 259 to the control group. We obtained complete follow-up data on 512 (99%) of 518 patients (five participants were lost to follow-up in the intervention group and one in the control group). 11 patients assigned to the intervention group did not complete the VHS in hospital. Overall, the intervention did not affect the number of people who re-presented with self-harm (67 [26%] of 254 patients in the intervention group vs 71 [28%] of 258 patients in the control group, odds ratio [OR] 0·90, 95% CI 0·58–1·39, p=0·63). The intervention had no effect on the number of re-presentations per patient (mean 0·67 [SD 2·55] re-presentations for the intervention group vs 0·85 [2·79] for the control group, incident rate ratio [IRR] 1·65, 95% CI 0·74–3·67, p=0·21). Mean total costs per person for NHS hospital services in the VHS intervention group over the 6 months were £513 versus £561 in the control group but this difference was not significant (95% CI–£353 to £257, p=0·76). Three patients died by suicide in the 6 months following their index suicide attempt (one in the intervention group and two in the control group). There were no reported unintended effects or adverse events in either group.InterpretationFor the primary outcomes, there were no significant differences between groups. Although the VHS had no overall effect, post-hoc analyses suggest VHS might be effective in reducing the number of self-harm repetitions following a suicide attempt in people who complete the helpsheet and who have been previously admitted to hospital with self-harm. This is the first study to investigate the usefulness of the VHS to reduce self-harm among those who have attempted suicide. These subgroup findings require replication. The potential use of the VHS in those who self-harm for different motives requires further exploration.FundingChief Scientist Office (CZH/4/704).

Advances in awareness monitoring technologies.

Initial studies suggested that the use of processed electroencephalogram technology could significantly decrease the incidence of unintended intraoperative awareness events during general anesthesia. Subsequent work has cast doubts on these findings. This review will examine the current state of awareness monitoring. Recently published randomized controlled trials examining the use of the bispectral index during general anesthesia have not been able to show superiority over other forms of monitoring depth of anesthesia, such as end-tidal anesthetic-agent concentration. Additionally, there is current interest in utilizing the unprocessed electroencephalogram to ascertain depth of anesthesia and recent studies have demonstrated its use in preventing postoperative delirium. Although awareness monitors such as the bispectral index monitor may have benefit in patients in whom volatile anesthetic agents must be minimized - such as in hemodynamically unstable patients, or patients undergoing total intravenous anesthesia - these monitors do not appear to be useful for all patients.

Shocking Tales: A Look at the Strange and Unexpected [Guest Editorial

The theme of shocking tales describes some unexpected power system events. It is the intention to offer ways in which power engineers can learn from these unintended events and apply lessons learned by thinking beyond the usual routinized system contingencies. Attention to standards, procedures, and training are vital to the operation of the system. System planners and engineering departments should carefully consider the addition of needed facilities that can improve the robust design and operation of the system.

International Guarantee for Social Security Rights

During their turbulent life, humans are always at risk of an unintended and unavoidable events and thus seek to gain pain relief and a way to avoid the consequences of accidents like this. Events such as unemployment, disability, illness, aging, etc. as well as natural disasters can undermine the livelihoods and well-being. In different periods of human life, the fundamental institutions such as family, tribe and relatives were somewhat supportive of their dependents when they were faced by the decisive events or reduction of income and livelihood, but with the industrialization and urbanization process, one of the most important consequences has been breaking the strong bonds of family and extended family, and thus a need to protect people from exposure to these risks and events was formed. With the creation of social security systems since the late nineteenth century, industrialization and urban communities started to protect their citizens against certain social risks, a process that has evolved over time and now most of the countries have social security schemes and systems with differences in the type and level of support to maintain incomes in cases of retirement, unemployment, old age, disability, orphaned, homelessness, disease and death, and to promote general well-being of individuals and communities. However, despite all the improvements achieved, there are still many problems in the realization of the right to social security. This research explain the contemporary process of standardization of the social security right and measures of states and international and regional organizations concerned to investigate the mechanisms to ensure implementation of the social security system and the provisions of international law and the national procedures.

Seeds capture the diversity of genetic resource collections of Malus sieversii maintained in an orchard

Many species in genebank collections are maintained vegetatively either as in vitro cultures or as plants in the field or greenhouse. In these cases, individual genotypes (cultivars) are the focus of conservation. In crop wild relatives, where the value of an accession is in the heterogeneity of segregating genotypes, seeds may be the most representative form of conservation. We used two sets of field-planted Malus sieversii apple trees that originated from seeds collected from two wild populations in Kazakhstan as a model system to determine if seeds from hand-pollinated crosses could be used to represent the allelic diversity of the parent trees in a genebank orchard. A crossing design was developed that used each of the selected trees from the two Kazakhstan collection sites as mothers and also as fathers in the form of bulked pollen pools. The sets of offspring from these crosses were genotyped using microsatellite markers. Paternity analyses revealed the percentage of offspring that was derived from each of the parent trees. We also determined the contribution of each parent to the fertilization events from the pollen pools. Although there were some unintended pollination events (fertilization by trees in unexpected pollen pools) and unequal contribution of pollen parents within pollen pools, we demonstrated that the seedlings effectively captured the allelic frequency and diversity of the parents. A seed collection strategy is the most efficient way to conserve the diversity of crop wild relatives even in collections typically conserved as individual clones.

Investigating Driver Sympathetic Arousal under Short-term Loads and Acute Stress Events

This study involved an investigation of patterns of arousal in a driver’s sympathetic nervous system toward a system that can detect high cognitive workload, high emotional load, and acute stress (surprise or panic) experiences in drivers. Humans are exposed to cognitive and physical stressors in the driving environment that can be exacerbated when drivers are operating under the cognitive effects of incidental emotions or secondary task loads. Each type of stressor can negatively affect the control of complex operational systems, such as a vehicle, in different ways. The body’s sympathetic autonomous nervous system (the “fight or flight” system) triggers several physiological changes in the body, such as perspiratory and cardiac dynamics, in order to prepare the human to defend themselves or run away. Physiological sensor systems can therefore be used to collect data on these physiological changes (such as heart rate variability (HRV; Taelman, Vandeput, Spaopon, & Van Huffel, 2009) and skin conductance response (SCR; Boucsein, 2012; Shi, Ruiz, Taib, Choi, & Chen, 2007; Villarejo, Zapirain, & Zorrilla, 2012). Data processing techniques can be applied to identify patterns in physiological response across multiple variables and time windows that are characteristics of potentially problematic driver mental states. As a first step toward developing an online system for detecting potentially-problematic driver mental states, this study sought to identify patterns in HRV and SCR data associated with each of these states, and to investigate the predictive power of such an algorithm for explaining aspects of driving behavior. Eighty-eight people (with equal representation from each sex and each of two age groups) participated in a driving simulator study. The simulation scenarios consisted of a simulated rural highway with multiple predetermined segments where secondary task loads were applied. After a physiological baselining procedure and adequate practice with the driving and secondary tasks, participants completed scenarios under each of the six driving conditions: a “Normal” drive with a simple roadway and no secondary tasks, four “Loaded” drives that included driving-related loads (e.g., construction zones) and some additional secondary tasks designed to impose analytical cognitive, emotional, and motoric (e.g., texting task) loads. A final scenario included varied combinations of these loads and a unique surprising “Failure” event (triggered acceleration in the vehicle that mimicked unintended acceleration problems). HRV and SCR were measured throughout the experiment using Zephyr Bioharness3 and Shimmer3 sensor systems, respectively, and numerous third-party software packages were used to process the data and identify noteworthy patterns. This presentation will report the analytical results of three dependent variables: HRV, SCR-amplitude (i.e., the magnitude of characteristic increases in arousal during sympathetic response), and SCR-frequency (i.e., the frequency of skin conductance responses identified within a predetermined time window). HRV (measured over time windows of a few seconds, as well as of several minutes) and SCR-Frequency were significantly sensitive to changes in loading, and some patterns in dynamics among multiple measures can be used to differentiate the designed mental states, although further testing is underway to refine and validate these findings. In particular, SCR- amplitude may be an effective way to distinguish acute stress events, as this measure shows a significant and substantial change within 2.5 seconds after realization of the unintended acceleration event. In addition to discussing these results, the current and future efforts in the development of an online driver “stressor detector” and mitigation system will be introduced in the presentation as well.

Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design.

BackgroundAdverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs.ObjectiveWe aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada.MethodsTo develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting.ResultsThis is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication of ADEs.ConclusionsWe take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers’ failure to account for organizational and work practice considerations, and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process (planned in partnership with end-users) will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians’ workflow, and design the system to optimize its uptake into practice.

Examining the impact of regular physician visits on heart failure patients: a use case with electronic health data

The rapid adoption of electronic health records (EHRs) presents opportunities to study care management within health systems. We examine the efficacy of using EHR data to assess the outcomes of outpatient care for chronic disease management. A retrospective-prospective study was conducted using 6 years of archived EHR data from patients treated for heart failure at a rural community hospital. Patients were placed into two cohorts, ‘Regular’ and ‘Non-Regular’, based on the frequency of provider contact. A hospital charge ratio was used to calculate cost. Patient mortality and the frequency of unintended events were used to assess patient outcomes. Case study results suggest that sporadic outpatient care was associated with greater utilization of more intensive health-care services. When inpatient and Emergency Department utilization became necessary for both groups, the Regular outpatient cohort had lower mortality rates, fewer readmissions, and incurred lower and less variable costs. Overall, the study showed great potential for using EHR data for assessing care outcomes, notwithstanding some key limitations. We conclude by discussing the types of insights possible and shortcomings attributed from health systems research derived from EHR data.

Helmet Using GSM and GPS Technology for Accident Detection and Reporting System

An accident is an unexpected and unintended event. In today’s world road accidents stand among the leading cause of human death, Road safety for driver is an essential requirement of society, As the Number of vehicles increase day by day, Collision of vehicle also Increases simultaneously, in this situation this project fulfils the Purpose of saving lives. Helmet is best safety equipment for driver. In this system initially we try to avoid accidents by using, a danger Zone indicator (RF transmitter) circuit, even though the accident occurred the vibration or MEMS sensor will activate the GPS to find the location and further SMS will send to ambulance and family members. This will optimize accidents as well as human death ratio by accidents due to providing proper care with in time frame. Another feature of the proposed system is the ability to detect an accident and send the corresponding geographical coordinates of the accident spot to predefined numbers using a GPS and GSM system respectively. After giving an overview of the system, the paper describes the system architecture, specific components used, logic flow employed and benefits of the system. This proposed system aims at making safety the norm and not a choice.

Systems pharmacology to predict drug safety in drug development

Ensuring that drugs are safe and effective is a very high priority for drug development and the US Food and Drug Administration review process. This is especially true today because of faster approval times and smaller clinical trials, especially in oncology and rare diseases. In light of these trends, systems pharmacology is seen as an essential strategy to understand and predict adverse drug events during drug development by analyzing interactions between drugs and multiple targets rather than the traditional “one-drug-one-target” approach. This commentary offers an overview of the current trends and challenges of using systems pharmacology to reduce the risks of unintended adverse events.

LO051: Validation of a clinical decision rule to detect patients with adverse drug events in the emergency department

Introduction: Adverse drug events (ADE) are a leading cause of emergency department (ED) visits, yet are missed in up to 50% of presentations. In 2014, Accreditation Canada, a not-for-profit organization that evaluates healthcare institutions based on quality of care, introduced a requirement for EDs to identify patients at high-risk for drug-related morbidity, so that medication management interventions can be targeted to high-risk groups. We derived a clinical decision rule to identify patients at high-risk for ADEs using 4 variables. Our objective was to validate the rule by determining its sensitivity and specificity in a new sample. Methods: We conducted a prospective observational study in two tertiary care and one urban community hospital in British Columbia and Ontario. We used a systematic selection algorithm to generate a representative sample, and enrolled adults who reported taking at least one medication during the prior two weeks. Nurses completed the clinical decision rule and evaluated patients for standardized clinical findings. Each patient was assessed by a research pharmacist and a physician who were blinded to data collected by nurses. Any disagreement was subsequently adjudicated by an independent committee. The primary outcome was an ADE, defined as an unintended and harmful event related to medication use resulting a change in medical management, hospital admission or causing death. We calculated the rule’s sensitivity, specificity, and the proportion of patients screening positive with 95% confidence intervals (CI). Results: Among 1529 enrolled patients, 196 (12.8%, 95% CI 11.2-14.6%) were deemed to have experienced an ADE. The rule, consisting of the variables (i) having a pre-existing medical condition or having taken antibiotics within one week, and (ii) age ≥ 80 or having a medication change within 28 days, had a sensitivity of 92.9% (95%CI 88.3%-96.0%) and a specificity of 35.0% (95%CI 32.5%-37.7%) for ADEs. The proportion of patients screening positive was 41.7%. Conclusion: Among adults presenting to EDs, the rule was sensitive for ADEs while maintaining reasonable specificity. If implemented, the rule may help identify those patients at high-risk for ADEs who may benefit from evaluation by a clinical pharmacist in the ED, and will help institutions meet current Accreditation Canada standards.

Integrative representations and analyses of vaccine-induced intended protective immunity and unintended adverse events using ontology-based and theory-guided approaches.

While effective preventive vaccines induce intended protective immunity, they also induce unintended adverse events (AEs). Generally speaking, compared to killed, inactivated vaccines and protein vaccines, live attenuated vaccines induce more protective immune responses. However, live attenuated vaccines are also associated with more AEs and even more serious AEs. For example, while live attenuated smallpox vaccines were critical to the eradication of smallpox, approximately 20–30% of smallpox vaccine recipients also experienced with various AEs that range in prevalence and severity [1]. Inter-individual variations in cytokine and AE response after smallpox vaccinations are in part due to genetic variation. For another example, the attenuated oral poliovirus vaccine (OPV) efficiently induces intestinal immunity and durable humoral immunity. However, OPV has the disadvantage of genetic instability, contributing to rare and sporadic cases of vaccine-associated paralytic poliomyelitis and the emergence of genetically divergent vaccine-derived polioviruses [2]. These AEs are worsened in patients with primary immunodeficiencies. These results suggest that the intended protective immune responses and unintended adverse events are correlated and deserve being studied simultaneously.

Roles of Pharmacist in Pharmacovigilance: A Need of the Hour

World Health Organization (WHO) defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problems. Pharmacovigilance plays an important role in ensuring patients drugs safety. Adverse Drug Reaction (ADR) is defined according to WHO as any response to a drug which is noxious and unintended and occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or the modification of physiological function. Complete information of unintended and severe adverse events could be finding through the Pharmacovigilance. It could not be done through clinical trials which are conducted in in-vivo method. Pharmacists are not mere preparing or dispensing of drugs. The professional practice reaches far beyond serving community. Pharmacists have an important responsibility in monitoring the on-going safety of medicines as part of their professional practice. Pharmacist role in pharmacovigilance varies from country to country, but the professional responsibility is the same regardless of jurisdiction. Pharmacists can create a trusted environment by counselling patients to reduce medication errors, improve safety and quality of care.

Datafication and the Seductive Power of Uncertainty—A Critical Exploration of Big Data Enthusiasm

This contribution explores the fine line between overestimated expectations and underrepresented momentums of uncertainty that correlate with the prevalence of big data. Big data promises a multitude of innovative options to enhance decision-making by employing algorithmic power to gather worthy information out of large unstructured data sets. Datafication—the exploitation of raw data in many different contexts—can be seen as an attempt to tackle complexity and reduce uncertainty. Accordingly promising are the prospects for innovative applications to gain new insights and valuable knowledge in a variety of domains ranging from business strategy, security to health and medical research, etc. However, big data also entails an increase in complexity that, together with growing automation, may trigger not merely uncertain but also unintended societal events. As a new source of networking power, big data has inherent risks to create new asymmetries and transform possibilities to probabilities that can inter alia affect the autonomy of the individual. To reduce these risks, challenges ahead include improving data quality and interpretation supported by new modalities to allow for scrutiny and verifiability of big data analytics.

Resistivity Arrays as an Early Warning System for Monitoring Runoff Holding Ponds

Monitoring wells are installed to intercept contaminants inadvertently discharged from inground structures designed to retain salt-affected wastewaters; however, several difficulties with collection and data interpretation limit their effectiveness. Therefore, improved monitoring methods are needed. The objective of this study was to evaluate the effectiveness of resistivity array technology as an early warning system to monitor for unintended basin discharge. Subsurface resistivity arrays were installed at two Nebraska sites: a beef cattle feedyard located at the U.S. Meat Animal Research Center, Clay Center, Nebraska (FyA) and a commercial cattle feeding operation (FyB). Monitoring well data did not identify any unintended discharge events during the study period. However, the resistivity array (RA) system detected a discharge event that was localized in the non-saturated zone adjacent to the pond at FyB within one day following a precipitation event. Monitoring the unsaturated portion allows the RA system a capacity beyond traditional monitoring wells, which can only intercept discharge carried in groundwater. Also, the RA system effectively measured a larger area (i.e., a virtual curtain) compared to the point measure typical of monitoring wells. Therefore, RA technology provides broader coverage and is more tolerant to placement issues for intercepting discharge. Finally, the capacity to automate the RA system provides a means to continuously monitor unintended subsurface discharge from runoff holding ponds. This continuous monitoring system is more likely to detect discharge events than the bi-annual sampling typically required for monitoring wells. Automatic and continuous monitoring provides feedyard operators options to better manage environmental impacts associated with runoff holding ponds.

Design-Based Safety

The word “safety” has a variety of meanings. It is a condition of being free from “accidents,” or any device for preventing an accident. The word “accident” means “unintended event,” and does not reveal that there is a cause created by a “hazard.” In many people’s minds, an “accident” is the result of someone’s failure to avoid or prevent a dangerous condition or circumstance. It is often assumed that all one needs to do is just “be safe.” Overlooked is that “hazards” are not obvious to everyone all of the time. It is a fact that as machines and systems become increasingly complex, many hazards are hidden. The evolution of safety is the transition of “behavior-based safety” to “design-based safety.”

Reasons for Randomness: A Solution to the Axiological Problem for Theists

In this paper we bring to light several ways randomness—i.e., undetermined and unintended events—may contribute to our understanding of God's providence and personality. We begin by making clearer a certain problem that randomness has been thought to pose to theism. We then discuss recent criticisms of certain contemporary solutions to this problem that emphasize the value of an autonomous creation. From there, we propose a fresh way of understanding the value of a semi-autonomous creation that does not succumb to these recent critiques. Our end goal is to explore new reasons God might have to value randomness. In particular, we highlight two plausible, interrelated candidate values: (1) There are certain aesthetic properties that a partially random, self-forming creation enjoys; and (2) Such a creation grants God and creatures certain pleasures, such as wonder, anticipation, curiosity, surprise, and appreciation. In articulating our version of the autonomy defense, we position it within two opposing accounts of divine providence, specifically open theism and simple foreknowledge.

Patient Safety Risks of Basic Urological Procedures Performed by Junior and Senior Residents

To investigate the current performance of urological residents regarding basic urological procedures in relation to patient safety issues and the identification of specific training needs. Observational data of 146 urethrocystoscopies (UCSs), 27 transrectal ultrasounds of the prostate (TRUSs), 38 transrectal ultrasound-guided prostatic biopsies (TRUSPs), and 30 transurethral resections of bladder tumor (TURBTs) were collected. Performance was evaluated using scoring lists including details on completeness of procedural steps, level of independence, time, and the incidence of unintended events. The causal factors contributing to the unintended events were identified by 2 expert urologists and classified according to the recognized PRISMA method. This study was performed in 5 teaching hospitals in the Netherlands. We included 11 junior residents and 5 senior residents in urology in the final study cohort. Senior residents showed a lower degree of completeness in material usage than junior residents did during UCS (p < 0.01) and in preparation, material usage, and procedure during TRUSP (all p < 0.05). In UCS and TURBT, senior residents received significantly less feedback than junior residents did (both p < 0.01). Incidence of unintended events for junior vs senior residents was 11% and 4% in UCS, 0% and 7% in transrectal ultrasound of the prostate, 36% and 62% in TRUSP, and 41% and 23% in TURBT, respectively. Overall, unintended events were mainly caused by human factors, in particular, verification and skills-based issues. Present performance of basic urological procedures involves a high percentage of unintended events, especially in TRUSP and TURBT, which are mainly caused by human factors and are a potential threat for patient safety. Junior residents are less independent but more thorough in the performance of UCS and TRUSP than senior residents are. Targeted skills training including assessment should be implemented before privileges for independent practice are granted to reduce the incidence of unintended events and optimize patient safety.