Predefined Events Research Articles

Low Occurrence of Predefined Safety Events Across Six Randomized Clinical Trials of Spesolimab in Dermatologic Conditions

Introduction In the randomized, placebo-controlled Effisayil 2 trial, the anti-interleukin (IL)-36 receptor antibody spesolimab demonstrated a reassuring safety profile when given over 48 weeks for flare prevention in patients with generalized pustular psoriasis (GPP). Nevertheless, given its novel mechanistic approach, it is important to characterize events relating to IL-36 inhibition with spesolimab as well as those of potential relevance to an intravenously/subcutaneously administered biologic. Methods In this analysis, rates of such predefined events – severe/serious/opportunistic infections, potential hypersensitivity reactions, peripheral neuropathies, and malignant tumors – were examined using available data from six randomized trials of spesolimab across various dermatologic conditions. Results Events reported in patients receiving spesolimab at various doses and schedules in two trials in GPP, two in palmoplantar pustulosis (PPP), one in atopic dermatitis (AD), and one in hidradenitis suppurativa (HS) were included (total n=345 for spesolimab and 145 for placebo). Exposure to spesolimab was: GPP, 244.3; PPP, 327.8; AD, 40.0; and HS, 45.7 patient-years, respectively. Rates of severe/serious/opportunistic infections were low with spesolimab (3.2% in one GPP trial; otherwise, 0% vs. 0% with placebo), and the incidences of hypersensitivity reactions were similar for spesolimab (7.7–33.3%) and placebo (5.6–44.4%) across trials. There was one report of peripheral neuropathy with spesolimab in a PPP trial (incidence 0–0.9% across trials) versus two (one GPP, one PPP) with placebo (0–3.3%), and one malignancy with spesolimab in GPP (0–1.1% across trials) versus one with placebo in PPP (0–2.3%). Conclusion These results support the favorable safety profile of spesolimab seen in Effisayil 2.

Spatial Patterns of Violence Against Women and Children using Geographic Information System and Density-Based Clustering Algorithm

This paper underscores the importance of the Density-Based Spatial Clustering of Applications with Noise (DBSCAN) algorithm in data mining. In this research, data mining clustering methods were applied to investigate consummated felonies related to the "Anti-Violence Against Women and Their Children Act of 2004 - RA 9262" from 2018 to 2023. The criminal data processed from the Police Regional Office 6 of the Philippine National Police encompassed 248 attributes reflecting cases over the specified period. The significance of this study lies in its utilization of ArcGIS Pro software to process the provided data through clustering techniques, presenting a robust approach for detecting criminal activities and recognizing patterns to aid law enforcement in crime reduction efforts. Spatial data mining proves practical when dealing with geographic crime datasets, facilitating the analysis of large volumes of crime data. The DBSCAN algorithm was employed to cluster crime incidents centered on predefined events, with the resultant clusters used to identify hotspots. These clustering outcomes are then visualized using GIS, enabling real-time mapping of crime distribution for law enforcement agencies to comprehend and engage with effectively. The outcomes empower stakeholders to devise interventions tailored to specific locations, thereby contributing to a safer environment for women and children. The study illuminates the localized analysis of crime distribution, offering insights into the interconnected factors influencing criminal incidents and providing a framework for crafting targeted and efficient strategies for crime prevention, thereby enriching the broader dialogue on crime management and public safety.

Safety and Adverse Events During Primary Care Paramedic Interfacility Transfer of Stable STEMI Patients

Objective Current guidelines recommend that patients presenting with ST-elevation myocardial infarction (STEMI) to hospitals not capable of performing primary percutaneous coronary intervention (PCI) be transferred to a PCI-capable hospital if reperfusion can be accomplished within 120 min. Most STEMI patients are accompanied by an advanced care paramedic (ACP, equivalent to EMT-P), nurse, or physician who can manage complications should they arise. In our region, stable STEMI patients are transported by primary care paramedics (PCPs, similar scope of practice to advanced EMT) in cases where a nurse, physician, or ACP paramedic is not available. Our goal was to describe adverse events and need for advanced interventions among initially stable STEMI patients during interfacility transfer by PCPs. Methods We reviewed ambulance and hospital records of initially stable STEMI patients (as determined by first set of vital signs documented by paramedics) transferred to a PCI-capable hospital by PCPs between March 1, 2014, and December 31, 2019. We identified whether pre-determined adverse clinical events occurred during the transport as well as the potential need for advanced care interventions not within the PCP scope of practice. Adverse events upon arrival in the PCI lab were also identified. Results Of 346 STEMI patients transferred, 179 met inclusion criteria. The mean age of included patients was 61 years (SD 12.1) and 74.9% (134/179) were male. Median transport interval was 36 min (IQR 3.0). During transport, 47/179 (26.0%) patients experienced pre-defined adverse events; for 16/47 (34%), one or more adverse events was major. Three patients met criteria for ACP interventions. One patient suffered a cardiac arrest and was promptly resuscitated with defibrillation by the PCPs. Conclusions We found PCP-interfacility transport of initially stable STEMI patients was safe and associated with a moderate proportion of adverse events, the majority of which did not require an advanced care intervention. These findings may help decision-making to avoid delays transferring stable patients to PCI-capable centers.

First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation.

Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.

The real-world safety of sacubitril / valsartan among older adults (≥75): A pharmacovigilance study from the FDA data

BackgroundHeart failure is a major cause of morbidity and mortality among older adults. Sacubitril-Valsartan (Sac/Val) has been shown to improve patients' outcomes; however, its safety profile among older adults has not been adequately examined. We therefore aimed to examine its safety profile among this population. MethodsWe conducted a retrospective pharmacovigilance study utilizing the FDA's database of safety reports (FAERS). We employed disproportionality analysis comparing Sac/Val to angiotensin receptor blockers (ARBs). We aim to evaluate the reporting of pre-defined adverse events associated with Sac/Val (hypotension, acute kidney injury (AKI), hyperkalemia and angioedema) in two age groups: adults (< 75 years) and older adults (≥ 75). For each subgroup, we calculated reporting odds ratio (ROR) and compared them by calculating P for interaction. ResultsThe FAERS database encompassed 18,432 unique reports of Sac/Val. Of them, 12,630 (68.5%) subjects were adults (< 75 years), and 5802 (31.5%) were older adults (≥ 75 years), with a median age (IQR) of 68 (59–77). When compared to ARBs, Sac/Val was associated with higher reporting of hypotension, lower reporting of acute kidney injury (AKI) and hyperkalemia, and similar reporting of angioedema. Notably, we did not observe a significant interaction between the age subgroups and the risk estimates (AKI: Pinteraction = 0.72, hyperkalemia: Pinteraction = 0.94, hypotension: Pinteraction = 0.31, and angioedema: Pinteraction = 0.61). ConclusionsIn this postmarking study, none of the prespecified adverse events was reported more frequently in older adults. These findings provide reassurance for safety use of Sac/Val in older adults.

Treatment patterns and outcomes in older adults with castration-resistant prostate cancer: Analysis of an Australian real-world cohort

IntroductionProstate cancer (PC) is the second commonest malignancy and fifth leading cause of cancer death in men worldwide. Older men are more likely to develop PC but are underrepresented in pivotal clinical trials, leading to challenges in treatment selection in the real-world setting. We aimed to examine treatment patterns and outcomes in older Australians with metastatic castration-resistant prostate cancer (mCRPC). Materials and MethodsWe identified 753 men with mCRPC within the electronic CRPC Australian Database (ePAD). Clinical data were analysed retrospectively to assess outcomes including time to treatment failure (TTF), overall survival (OS), PSA doubling time (PSADT), PSA50 response rate, and pre-defined adverse events of special interest (AESIs). Descriptive statistics were used to report baseline characteristics, stratified by age groups (<75y, 75-85y and >85y). Groups were compared using Kruskal-Wallis and Chi-square analyses. Time-to-event analyses were performed using Kaplan-Meier methods and compared through log-rank tests. Cox proportional hazards univariate and multivariate analyses were performed to evaluate the influence of variables on OS. ResultsFifty-seven percent of men were aged <75y, 31% 75-85y, and 12% >85y. Patients ≥75y more frequently received only one line of systemic therapy (40% of <75y vs 66% 75-85y vs 68% >85y; P < 0.01). With increasing age, patients were more likely to receive androgen receptor signalling inhibitors (ARSIs) as initial therapy (42% of <75y vs 70% of 75-85y vs 84% of >85y; p < 0.01). PSA50 response rates or TTF did not significantly differ between age groups for chemotherapy or ARSIs. Patients >85y receiving enzalutamide had poorer OS but this was not an independent prognostic variable on multivariate analysis (hazard ratio [HR] 0.93(0.09–9.35); p = 0.95). PSADT >3 months was an independent positive prognostic factor for patients receiving any systemic therapy. Older patients who received docetaxel were more likely to experience AESIs (18% in <75y vs 37% 75-85y vs 33% >85y, p = 0.038) and to stop treatment as a result (21% in <75y vs 39% in 75-85y; p = 0.011). DiscussionIn our mCRPC cohort, older men received fewer lines of systemic therapy and were more likely to cease docetaxel due to adverse events. However, treatment outcomes were similar in most subgroups, highlighting the importance of individualised assessment regardless of age.

Towards smart contract distributed directory based on the uniform description language

A Smart Contract (SC) is a piece of code executed on the blockchain to automatically trigger transactions upon the occurrence of predefined events. Due to the intrinsic features regarding traceability and data immutability, many companies started using blockchain Smart Contracts to perform collaborative processes. Despite their promising features, there is a lack of Smart Contacts management platforms that enable blockchain participants to describe and publish their smart contacts or “search and match” already deployed ones. In this paper, a new Distributed Smart Directory (DSD) where providers can publish their SCs description is proposed. The SCs descriptions include metadata covering functional, and non-functional properties of the SC. Hence, users can find SCs according to their non-functional preferences, needs, and constraints. The proposed DSD is an extension of the ebXML directory. It was fully implemented on-chain. The SCs descriptions are generated based on the Uniform Description language for SC (UDL-SC). The proposed solution is implemented on the Ethereum blockchain. It was then tested and evaluated.

IOT Based Home Automation System over Cloud

Abstract: The proposed home automation system capitalizes on the NodeMCU board's versatility and the Arduino IoT Cloud platform's capabilities to establish a robust and efficient solution. This powerful combination enables seamless connectivity, real-time data exchange, and remote control of home devices via the internet and Alexa Voice Assistance integration. Users can effortlessly monitor and manage their homes from anywhere using web or mobile interfaces, offering unparalleled flexibility. The IoT home automation system encompasses essential features such as device control, energy management, security, and environmental monitoring. Leveraging the Arduino IoT Cloud platform, users gain easy access to configure and personalize their automation settings. They can establish custom rules and receive notifications based on predefined events or specific conditions, enhancing their overall automation experience.

Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics

ABSTRACT A fundamental problem in the regulatory evaluation of a therapy is assessing whether the benefit outweighs the associated risks. This work proposes designing a trial that assesses a composite endpoint consisting of benefit and risk, hence, making the core of the design of the study, to assess benefit and risk. The proposed benefit risk measure consists of efficacy measure(s) and a risk measure that is based on a composite score obtained from pre-defined adverse events of interest (AEI). This composite score incorporates full aspects of adverse events of interest (i.e. the incidence, severity, and duration of the events). We call this newly proposed score the AEI composite score. After specifying the priorities between the components of the composite endpoint, a win-statistic (i.e. win ratio, win odds, or net benefit) is used to assess the difference between treatments in this composite endpoint. The power and sample size requirements of such a trial design are explored via simulation. Finally, using Dupixent published adult study results, we show how we can design a paediatric trial where the primary outcome is a composite of prioritized outcomes consisting of efficacy endpoints and the AEI composite score endpoint. The resulting trial design can potentially substantially reduce sample size compared to a trial designed to assess the co-primary efficacy endpoints, therefore it may address the challenge of slow enrollment and patient availability for paediatric studies.

Learning to automatically spectate games for Esports using object detection mechanism

Human game observers, who control in-game cameras and provide viewers with an engaging experience, are a vital part of electronic sports (Esports) which has emerged as a rapidly growing industry in recent years. However, such a professional human observer poses several problems. For example, they are prone to missing events occurring concurrently across the map. Further, human game observers are difficult to afford when only a small number of spectators are spectating the game. Consequently, various methods to create automatic observers have been explored, and these methods are based on defining in-game events and focus on defined events. However, these event-based methods necessitate detailed predefined events, demanding high domain knowledge when developing. Additionally, these methods cannot show scenes that contain undefined events. In this paper, we propose a method to overcome these problems by utilizing multiple human observational data and an object detection method, Mask R-CNN, in a real-time strategy game (e.g., StarCraft). By learning from human observational data, our method can observe scenes that are not defined as events in advance. The proposed model utilizes an object detection mechanism to find the area where the human spectator is interested. We consider the pattern of the two-dimensional spatial area that the spectator is looking at as the object to find, rather than treating a single unit or building as an object which is conventionally done in object detection. Consequently, we show that our automatic observer outperforms both current rule-based methods and human observers. The game observation video that compares our method and the rule-based method is available at https://www.youtube.com/watch?v=61JIfSrLHVk.

ASCUE: An Adversarial Network-Based Semantical Conformance Checking Method for Unsupervised Event Extraction in Social Internet of Things

Abstract Event extraction (EE) methods are widely used in the Social Internet of Things (SIoT) to help objects obtain the key information from messages shared by other objects. Existing supervised EE methods can only extract predefined events and can hardly extract events with unseen event types. To address this issue, we propose an unsupervised EE method based on the idea of semantic role labeling. However, after extracting all possible events from a given message text, some of these events face the semantically inconsistent issue that will destroy the information credibility in SIoT. To solve this issue, we present ASCUE, an adversarial network-based semantic conformance checking method for unsupervised EE in SIoT. Briefly, ASCUE first mines all the event candidates from a given text unsupervisedly. Next, ASCUE introduces two independent Bidirectional Encoder Representations from Transformers models to capture the semantics of the event candidate and text, respectively. Moreover, to enable the model to achieve competitive performance as label embedding for semantic conformance checking, an adversarial network is added into ASCUE’s training stage. Finally, ASCUE extracts all the events that are semantically consistent with the original text by classifying them into two categories: semantically consistent and semantically inconsistent. In addition, since the existing datasets do not label whether the events are semantically consistent with the original text, we re-annotate an existing dataset to fit our task. Experimental results on the re-annotated dataset show that our model outperforms the state-of-the-art baselines in terms of accuracy and F1 scores.

Effects of dynamic individualized PEEP guided by driving pressure in laparoscopic surgery on postoperative atelectasis in elderly patients: a prospective randomized controlled trial

BackgroundDriving pressure (ΔP = Plateau pressure-PEEP) is highly correlated with postoperative pulmonary complications (PPCs) and appears to be a promising indicator for optimizing ventilator settings. We hypothesized that dynamic, individualized positive end-expiratory pressure (PEEP) guided by ΔP could reduce postoperative atelectasis and improve intraoperative oxygenation, respiratory mechanics, and reduce the incidence of PPCs on elderly patients undergoing laparoscopic surgery.MethodsFifty-one elderly patients who were subject to laparoscopic surgery participated in this randomized trial. In the PEEP titration group (DV group), the PEEP titration was decremented to the lowest ΔP and repeated every 1 h. Additional procedures were also performed when performing predefined events that may be associated with lung collapse. In the constant PEEP group (PV group), a PEEP of 6 cmH2O was used throughout the surgery. Moreover, zero PEEP was applied during the entire procedure in the conventional ventilation group (CV group). The primary objective of this study was lung ultrasound score noted at the end of surgery and 15 min after admission to the post-anesthesia care unit (PACU) at 12 lung areas bilaterally. The secondary endpoints were perioperative oxygenation function, expiratory mechanics, and the incidence of the PPCs.ResultsThe lung ultrasound scores of the DV group were significantly lower than those in the PV group and CV group (P < 0.05), whereas there was no significant difference between the PV group and CV group (P > 0.05). The lung static compliance (Cstat) and ΔP at all the intraoperative time points in the DV group were significantly better compared to the PV group and the CV group (p < 0.05).ConclusionsIntraoperative titrated PEEP reduced postoperative lung atelectasis and improved respiratory mechanics in elderly patients undergoing laparoscopic surgery. Meanwhile, standard PEEP strategy is not superior to conventional ventilation in reducing postoperative pulmonary atelectasis in laparoscopic surgery.

Abstract 9070: Use of Commercial Outpatient Monitoring for Near-Real-Time, Acute- and Subacute-Care Telemetry Like Monitoring in Covid-19 Pandemic

Introduction: Limited data exist on the role of commercial mobile cardiac telemetry (MCT) monitoring with QT capability as a near-real-time inpatient monitoring tool for COVID-19 stable patients. Our aim was to determine whether outpatient MCT monitoring could be adapted for near-real-time inpatient arrhythmia and QT monitoring during the COVID-19 pandemic. Methods: We conducted a prospective observational study on patients ≥18 years old with confirmed COVID-19 who required hospitalization between June and December 2020. Data including baseline characteristics and laboratory data were collected. Cardiac rhythms monitored using the MCT monitors (Medilynx Pocket ECG) were analyzed (beat-to-beat analysis). Off-site technicians monitored for arrhythmias 24/7 and notified the physician based on the pre-defined events (QTc ≥500 ms with QRS &lt;120 ms or QTc &gt;520 ms with QRS ≥120 ms or atrial and/or ventricular tachyarrhythmia ≥5 beats). Primary endpoint was the detection of any of the pre-defined events. Results: 29 patients were enrolled in this study. 65.5% were female. There were no significant differences except age in baseline characteristics and laboratory data between those with and without events. Patient age was a significant predictor of events at multivariable analysis [odds ratio 1.08, 95% CI (1.01 - 1.15); P = 0.023]. Table 1 showed the overall number and events recorded on the MCT monitors. Two patients had new-onset atrial fibrillation (AF) and 5 patients had AF with heart rate &gt;100 bpm. In retrospective analysis, these findings correlated with the 12-lead ECGs performed during their hospital stays. Two patient had significant QTc prolongation noted on the MCT monitor. No adverse events occurred in any of the monitored patients. Conclusions: Our results showed that commercial MCT monitoring can potentially provide a system for detecting clinically relevant arrhythmias and QT prolongation, especially if there is a subsequent shortage of telemetry monitors.

Optimisation of airway management strategies: a prospective before-and-after study on events related to airway management

BackgroundPoor medical outcomes often result from series of minor events. The present study assessed events related to airway management to determine whether targeted changes to departmental strategies for airway management can reduce the incidence. MethodsThis prospective before-and-after study was performed with ethics committee approval and written informed consent from patients. Major and minor events related to airway management were prospectively recorded for 9 weeks. After implementation of changes to departmental strategies for airway management, events were again prospectively recorded over 9 weeks. Primary outcome was number of cases with events. Secondary outcomes were various predefined events. ResultsAt study baseline, 3668 cases and at follow-up 3786 cases were assessed. Cases with events decreased from 566 (15.4%) to 433 (11.4%) (risk ratio [RR]=0.74; 95% confidence interval [CI], 0.66–0.83; P<0.01). As secondary outcomes, the following events decreased: Cormack–Lehane grade 3 or 4 (4.3–2.9%; RR=0.67; 95% CI, 0.52–0.85; P<0.01); difficult bag-mask ventilation (3.8–2.7%; RR=0.69; 95% CI, 0.54–0.89; P<0.01); hypoxaemia (3.8–2.9%; RR=0.75; 95% CI, 0.59–0.96; P=0.03); unplanned use of special equipment (3.2–2.0%; RR=0.62; (95% CI, 0.47–0.83; P<0.01); oesophageal intubation (1.3–0.8%; RR=0.61; 95% CI, 0.39–0.96; P=0.03); bleeding (0.8–0.2%; RR=0.30; 95% CI, 0.14–0.63; P<0.01); insufficient spontaneous breathing (0.3–0.0%; RR=0.09; 95% CI, 0.01–0.68; P<0.01); communication errors (0.1–0.0%; RR=0; 95% CI, 0–NA; P=0.03). ConclusionsImplementation of changes to departmental strategies for airway management significantly reduced cases with events related to airway management. Analysis of events and implementation of strategies that specifically target identified issues might be key to improving airway management. Clinical trial registrationNCT02743767.

A new remote monitor and control system based on SigFox IoT network.

We describe a new, low-cost system designed to provide multi-sensor remote condition monitoring of modern scientific laboratories and to allow users to perform actions from remote locations in the case of detection of specified events. The system is battery operated and does not require the presence of a local area network or WiFi (which are typically not available in the case of, e.g., power losses), as it exploits the growing infrastructure of Internet of Things low-power wide area networks. In particular, our system exploits the new SigFox ultra-narrow-bandwidth infrastructure and provides a bidirectional link between the instrumentation and the remote user even in the case of power line outages, which are among the most critical situations that a scientific laboratory can withstand. The system can detect the occurrence of predefined events in very short times and autonomously react with a series of predefined actions, also allowing a remote user to timely perform additional actions on the system through a user-friendly smartphone application or via a browser interface. The system also embeds a novel power loss detection architecture, which detects power line failures in less than 2ms. We provide a full characterization of the prototype, including reaction times, connection latencies, sensor sensitivity, and power consumption.

Safe and effective use of active robotics for TKA: Early results of a multicenter study

BackgroundA novel active robotic system for total knee arthroplasty (TKA) performs automated milling of bone surfaces. Study objectives were to assess system safety and effectiveness in a US population. MethodsA multicenter clinical trial was conducted, following 115 patients for at least 6-months. A pre-defined list of robot-related adverse events was used to evaluate safety. Efficacy was assessed radiographically comparing planned versus achieved coronal limb alignment. ResultsNo pre-defined adverse events occurred and postoperative limb alignment more than ±3° from plan occurred in 11.2 % of cases. ConclusionActive robotics for TKA is safe and effective as demonstrated in this trial.

Low-Overhead Adaptive Brightness Scaling for Energy Reduction in OLED Displays

Organic Light Emitting Diode (OLED) is rapidly emerging as the mainstream mobile display technology. This is posing new challenges on the design of energy-saving solutions for OLED displays, specifically intended for interactive devices such as smartphones, smartwatches and tablets. To this date, the standard solution is brightness scaling. However, the amount of the scaling is typically set statically (either by the user, through a setting knob, or by the system in response to predefined events such as low-battery status) and independently of the displayed image. In this work we describe a smart computing technique called Low-Overhead Adaptive Brightness Scaling (LABS), that overcomes these limitations. In LABS, the optimal content-dependent brightness scaling factor is determined automatically for each displayed image, on a frame-by-frame basis, with a low computational cost that allows real-time usage. The basic form of LABS achieves more than 35 percent power reduction on average, when applied to different image datasets, while maintaining the Mean Structural Similarity Index (MSSIM) between the original and transformed images above 97 percent.

Comparison of Emergency Medical Dispatch Systems for Performance of Telecommunicator-Assisted Cardiopulmonary Resuscitation Among 9-1-1 Callers With Limited English Proficiency

Increasing bystander cardiopulmonary resuscitation (CPR) among racial/ethnic minority groups and culturally underserved populations is a key strategy in improving health care disparities in out-of-hospital cardiac arrest. To ascertain whether implementation of the Los Angeles Tiered Dispatch System (LA-TDS) was associated with improved performance of telecommunicator-assisted CPR (T-CPR) among 9-1-1 callers with limited English proficiency in the City of Los Angeles. This cohort study compared emergency medical services-treated, nontraumatic out-of-hospital cardiac arrest calls using the Medical Priority Dispatch System (MPDS) from January 1 to March 31, 2014, with calls using LA-TDS from January 1 to March 31, 2015. Trained data abstractors evaluated all 9-1-1 audio recordings for the initiation of T-CPR and the elapsed time to predefined events. Data were analyzed between January and December 2017. The primary outcome was the prevalence of T-CPR among 9-1-1 callers with limited English proficiency for field-confirmed nontraumatic cardiac arrests. Additional outcomes included T-CPR among callers with English proficiency and the elapsed time until key events in the call. Of the 1027 emergency medical services calls during the study periods, 597 met the inclusion criteria. A total of 289 calls (48%) were made using MPDS (263 callers with English proficiency, and 26 callers with limited English proficiency), and 308 calls (52%) were made using LA-TDS (273 callers with English proficiency, and 35 callers with limited English proficiency). No differences between MPDS and LA-TDS cohorts were found in age, sex, known comorbidities, arrest location (private vs public), or witnessed status. The prevalence of T-CPR among callers with limited English proficiency was significantly greater using LA-TDS (69%) vs MPDS (28%) (odds ratio [OR], 5.66; 95% CI, 1.79-17.85; P = .003). For callers with English proficiency, the prevalence of T-CPR improved from 55% using MPDS to 67% using LA-TDS (OR, 1.66; 95% CI, 1.15-2.41; P = .007). With LA-TDS, callers with limited English proficiency had a significant decrease in time to recognition of cardiac arrest (OR, 0.59; 95% CI, 0.41-0.84; P = .005) and dispatch of resources (OR, 0.71; 95% CI, 0.54-0.94; P = .02). The LA-TDS compared with MPDS was associated with increased performance of T-CPR for out-of-hospital cardiac arrests involving 9-1-1 callers with limited English proficiency. Further studies are needed in communities with a predominance of people with limited English proficiency to characterize bystander response, promote activation of the chain of survival, and clarify the precise elements of LA-TDS that can improve T-CPR performance.

MO559ASCEND-ND: STUDY DESIGN AND BASELINE CHARACTERISTICS

Abstract Background and Aims The Anemia Study in Chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor (PHI) Daprodustat-Non-Dialysis (ASCEND-ND; NCT02876835) trial is evaluating the efficacy and safety of daprodustat when compared with darbepoetin alfa in CKD patients with anaemia not requiring dialysis. We report the trial design as well as key baseline characteristics of participants. Method Eligible patients from 39 countries were adults with CKD stages 3–5 who were able to provide informed consent and demonstrated adherence to daprodustat placebo tablets and study procedures during the run-in period. Patients were eligible if (1) they were not using erythropoiesis stimulating agents (ESAs) and had a screening haemoglobin (Hb) 8 to 10 g/dL or if (2) they were receiving ESAs with screening Hb of 8 to 12 g/dL. Patients were required to be iron replete [transferrin saturation (TSAT) &amp;gt;20% and serum ferritin &amp;gt;100 ng/mL] at screening. Participants were randomised to daprodustat or darbepoetin alfa (1:1) in an open-label (sponsor-blind) trial design with blinded endpoint assessment. An IDMC conducts regular reviews of unblinded safety and efficacy data and makes recommendations for additions or adjustments. An external, independent and blinded Clinical Events Classification (CEC) group, led by the Duke Clinical Research Institute, in collaboration with George Clinical, adjudicate predefined events. During the study, both groups had randomised treatment adjusted using a protocol-defined algorithm targeting a Hb range of 10 to 11 g/dL. Participants also followed protocol-defined iron management criteria to ensure they remained iron replete. Additionally, an anaemia rescue algorithm was in place to minimise the risk of extended periods of inadequate Hb response and to ensure consistent application of rescue therapy across the study. The co-primary endpoints are mean change in Hb between baseline and Evaluation Period (EP; Weeks 28 to 52, inclusive) and time to first adjudicated major adverse cardiovascular event (MACE; composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke). The study has more than 99% power for the Hb non-inferiority (NI) test with an NI margin of -0.75 g/dL for the treatment difference of mean change in Hb between baseline and EP, and approximately 90% power to exclude the NI margin of 1.25 for time to first adjudicated MACE, for daprodustat compared with darbepoetin alfa. Conditional on both co-primary endpoints achieving NI at the one-sided 2.5% level, statistical testing will progress to evaluate MACE and the principal secondary endpoint of CKD progression for superiority. These tests will be multiplicity adjusted. Results A total of 3872 patients were randomised (median age 67 years, 56% female; 55% white, 28% Asian, and 10% black). The median baseline Hb was 9.8 g/dL, serum ferritin was 274 ng/mL, TSAT 30%, and eGFR 18 mL/min/1.73 m2. Among randomised patients, 54% were ESA non-users, 57% reported a history of diabetes mellitus and 36% a history of cardiovascular disease. Median blood pressure was 135/74 mmHg. Sixty percent of participants were taking angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, while 57% were taking lipid modifying agents at baseline. The trial is expected to complete during 2021. Conclusion ASCEND-ND will define the efficacy and safety of daprodustat compared with darbepoetin alfa in the treatment of patients with anaemia associated with CKD not requiring dialysis.

A Virtual Reality-Based App to Educate Health Care Professionals and Medical Students About Inflammatory Arthritis: Feasibility Study.

BackgroundInflammatory arthritides (IA) such as rheumatoid arthritis or psoriatic arthritis are disorders that can be difficult to comprehend for health professionals and students in terms of the heterogeneity of clinical symptoms and pathologies. New didactic approaches using innovative technologies such as virtual reality (VR) apps could be helpful to demonstrate disease manifestations as well as joint pathologies in a more comprehensive manner. However, the potential of using a VR education concept in IA has not yet been evaluated.ObjectiveWe evaluated the feasibility of a VR app to educate health care professionals and medical students about IA.MethodsWe developed a VR app using data from IA patients as well as 2D and 3D-visualized pathological joints from X-ray and computed tomography–generated images. This VR app (Rheumality) allows the user to interact with representative arthritic joint and bone pathologies of patients with IA. In a consensus meeting, an online questionnaire was designed to collect basic demographic data (age, sex); profession of the participants; and their feedback on the general impression, knowledge gain, and potential areas of application of the VR app. The VR app was subsequently tested and evaluated by health care professionals (physicians, researchers, and other professionals) and medical students at predefined events (two annual rheumatology conferences and academic teaching seminars at two sites in Germany). To explore associations between categorical variables, the χ2 or Fisher test was used as appropriate. Two-sided P values ≤.05 were regarded as significant.ResultsA total of 125 individuals participated in this study. Among them, 56% of the participants identified as female, 43% identified as male, and 1% identified as nonbinary; 59% of the participants were 18-30 years of age, 18% were 31-40 years old, 10% were 41-50 years old, 8% were 51-60 years old, and 5% were 61-70 years old. The participants (N=125) rated the VR app as excellent, with a mean rating of 9.0 (SD 1.2) out of 10, and many participants would recommend use of the app, with a mean recommendation score of 3.2 (SD 1.1) out of 4. A large majority (120/125, 96.0%) stated that the presentation of pathological bone formation improves understanding of the disease. We did not find any association between participant characteristics and evaluation of the VR experience or recommendation scores.ConclusionsThe data show that IA-targeting innovative teaching approaches based on VR technology are feasible.