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At least 19 records

Report to the President: A Transformational Effort on Patient Safety

The President’s Council of Advisors on Science and Technology (PCAST) is the sole body of advisors from outside the federal government charged with making science, technology, and innovation policy recommendations to the President and the White House. Established by Executive Order, it is an independent Federal Advisory Committee comprised of distinguished individuals from industry, academia, and non-profit organizations with a range of perspectives and expertise. On September 7, 2023, PCAST sent a report to the President with recommendations to develop and deploy policies and technologies that will improve patient safety in the United States, dramatically reducing harms to patients and healthcare workers.

99 GENERAL AND MISCELLANEOUS↗

Future needs for biomedical transducers

In summary there are three major classes of transducer improvements required: improvements in existing transducers, needs for unexploited physical science phenomena in transducer design, and needs for unutilized physiological phenomena in transducer design. During the next decade, increasing emphasis will be placed on noninvasive measurement in all of these areas. Patient safety, patient comfort, and the need for efficient utilization of the time of both patient and physician requires that noninvasive methods of monitoring be developed.

Wooten, F. T.↗

EHR-BERT: A BERT-based model for effective anomaly detection in electronic health records

Objective: Physicians and clinicians rely on data contained in electronic health records (EHRs), as recorded by health information technology (HIT), to make informed decisions about their patients. The reliability of HIT systems in this regard is critical to patient safety. Consequently, better tools are needed to monitor the performance of HIT systems for potential hazards that could compromise the collected EHRs, which in turn could affect patient safety. In this paper, we propose a new framework for detecting anomalies in EHRs using sequence of clinical events. This new framework, EHR-Bidirectional Encoder Representations from Transformers (BERT), is motivated by the gaps in the existing deep-learning related methods, including high false negatives, sub-optimal accuracy, higher computational cost, and the risk of information loss. EHR-BERT is an innovative framework rooted in the BERT architecture, meticulously tailored to navigate the hurdles in the contemporary BERT method; thus, enhancing anomaly detection in EHRs for healthcare applications.Methods: The EHR-BERT framework was designed using the Sequential Masked Token Prediction (SMTP) method. This approach treats EHRs as natural language sentences and iteratively masks input tokens during both training and prediction stages. This method facilitates the learning of EHR sequence patterns in both directions for each event and identifies anomalies based on deviations from the normal execution models trained on EHR sequences.Results: Extensive experiments on large EHR datasets across various medical domains demonstrate that EHR-BERT markedly improves upon existing models. It significantly reduces the number of false positives and enhances the detection rate, thus bolstering the reliability of anomaly detection in electronic health records. This improvement is attributed to the model’s ability to minimize information loss and maximize data utilization effectively.Conclusion: EHR-BERT showcases immense potential in decreasing medical errors related to anomalous clinical events, positioning itself as an indispensable asset for enhancing patient safety and the overall standard of healthcare services. The framework effectively overcomes the drawbacks of earlier models, making it a promising solution for healthcare professionals to ensure the reliability and quality of health data.

96 KNOWLEDGE MANAGEMENT AND PRESERVATION↗

Adaptive Anomaly Detection for Dynamic Clinical Event Sequences

Over the past decade, health information technology (IT) has enabled the amount of digital information stored in electronic health records (EHRs) to expand greatly. However, according to some studies, hazards in health IT can lead to changes in clinical decisions, care processes, and care outcomes, as well as other issues. Thus, the effects of health IT hazards on patient safety have been at the forefront of recent patient safety research. Nonetheless, hazard detection in health IT remains a challenge. In this paper, the authors assume that safety-related issues in health IT would exhibit anomalous characteristics in EHR data. Although all hazards will exhibit some anomalous characteristics, not all anomalies can be regarded as hazards. The authors hypothesize that errors in health IT could lead to interruptions in the sequence of clinical actions. To this end, the problem of detecting anomalous sequences in big EHR data is considered. This paper focuses on dynamic event sequences, which are a series of clinical actions in motion. The authors propose an adaptive anomaly detection approach that uses higher-order network representation to detect anomalous sequences. Furthermore, the authors propose a contiguous subsequence anomaly detection approach that identifies abnormal subsequences in the detected anomalous sequences. The proposed approaches are tested by using synthetic and real-world EHR data. The proposed methods outperform existing state of the art anomaly detection techniques. To reduce the computational complexity associated with the operational implementation of the proposed approaches, the Apache Spark environment was leveraged, and a much shorter run time together with improved performance were achieved, especially for data with more than 60,000 sequences.

Niu, Haoran↗

Integrated Spatial, Spectral, & Temporal Optical Reflectance System for Precision Occupancy & Location Sensing to Improve Building Energy Efficiency

Buildings consume approximately 35% of the electricity used in the U.S. and building owners can significantly reduce this energy use by providing services like heating, electrical power and lighting only when people are present. The ARPAe funded program titled “INTEGRATED SPATIAL, SPECTRAL, & TEMPORAL OPTICAL REFLECTANCE SYSTEM FOR PRECISION OCCUPANCY & LOCATION SENSING TO IMPROVE BUILDING ENERGY EFFICIENCY” demonstrates how a low cost sensor technology developed for measuring distances can be used to count and locate occupants with a high degree of precision with a very low error rates. This platform tells a building control system where occupants are located (but not who they are) so that energy consuming services can be provided only when the services are needed by building occupants. The original proof of concept involved using low cost, commercially available time-of-flight (TOF) sensors that measure distance, but the performance of these existing sensors was lacking, as they could not operate properly in the presence of sunlight, which blinded the simple TOF sensors and limited their utility in buildings. This project proposed a powerful new class of TOF sensors that used state-of-the-art integrated circuit (IC) fabrication processes that combined advanced photonics with conventional silicon chip circuitry for improved sensor performance. An equally important part of this project was to find ways to maximize occupant count and location accuracy while using the fewest number of sensors possible, in order to keep costs low. By using building blueprints to create digital twins of commercial building spaces, the team developed new algorithms to maximize occupant count and tracking accuracy by properly locating the minimum number of sensors at just the right spots in the building. This capability not only minimizes system costs but also simplified sensor installation and system commissioning. Our simulations of our sensor networks for a range of commercial floorplan designs demonstrated that our installed cost target of $0.08/sqft was attainable, though not fully demonstrated during the project. Finally, we noted that the TOF sensor concept could provide a valuable role in health and eldercare by tracking patients without the need for worn sensors and would be useful for fall detection and other patient safety metrics, including tracking healthcare/patient interactions. We feel that, when fully developed, this new class of sophisticated TOF sensors and support software will be a powerful new approach to improving building energy efficiency based on occupant centric control platforms and will also open new levels of patient safety in healthcare operations. To realize this potential, the team formed the Troy Sensor Company LLC to oversee licensing of the programs patents and continue to seek commercialization of this program’s activity sensing technologies.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

Anomaly Detection in Electronic Health Records Across Hospital Networks: Integrating Machine Learning With Graph Algorithms

In a large hospital system, a network of hospitals relies on electronic health records (EHRs) to make informed decisions regarding their patients in various clinical domains. Consequently, the dependability of the health information technology (HIT) systems responsible for collecting EHR data is of utmost importance for patient safety. Recently, novel methods and tools aimed at identifying anomalies in EHR data to bolster the reliability of HIT systems have been introduced. However, these existing methods and tools primarily concentrate on individual hospitals, which limits our understanding of system-wide anomalous events and their potential impact on patient safety across multiple hospitals. In this article, we introduce a new approach to detecting anomalies in EHR data within a network of hospitals. This is achieved by combining advanced machine learning techniques with graph algorithms to create a tool capable of swiftly identifying and responding to deviations. Our proposed approach employs a combination of five machine learning models, harnessing the unique strengths of each model to provide a more robust detection system. The detected anomalies are then represented as graphs, allowing us to recognize patterns across the hospital network. This aids in identifying anomalies that span multiple medical facilities, potentially indicating broader system-level risks. Extensive real-world testing of our approach demonstrated its ability to offer actionable insights compared to existing methods. Additionally, its scalable design ensures seamless integration into existing HIT infrastructures.

Niu, Haoran [Oak Ridge National Laboratory (ORNL),↗

A New Cure for Medical Errors

In May 2000, senior officials of the U.S. Department of Veterans Affairs (VA) and NASA signed an agreement that would commit the two agencies to create the Patient Safety Reporting System (PSRS) to report: events or situations that could have resulted in accident, injury, or illness, but did not, either by chance or through timely intervention (close-calls); unexpected serious occurrences that involved a patient or employee's death, physical injury, or psychological injury; lessens learned; and safety ideas. The VA provided NASA with funding for the initial development of the new system, which automatically removes all personal names, facility names and locations, and other potentially identifying information before entering reports into its database. Designed to complement the VA's current internal reporting systems, the PSRS is modeled after NASA's Aviation Safety Reporting System, which was established in 1975 under a Memorandum of Agreement between the Federal Aviation Administration and NASA and began operation in 1976.

Source record↗

Emerging anomaly detection techniques for electronic health records: A survey

Background Anomaly detection in electronic health records (EHRs) is a cornerstone of biomedical informatics, with direct implications for patient safety, clinical decision-making, and the prevention of healthcare fraud. Once guided primarily by simple rule-based methods, the field has advanced rapidly, driven by increased computing power, richer and more detailed health data, and the rise of machine learning and deep learning techniques. The objective of this paper is to provide a comprehensive overview of modern approaches to detecting anomalies in EHRs, outlining their strengths, limitations, and relevance to key healthcare challenges. We review traditional statistical methods alongside newer ML- and DL-based strategies and hybrid models, with particular attention to how these techniques support transparency and build clinical trust. Methods This paper presents a thorough and critical survey through systematic review (PRISMA-based) of the latest anomaly detection strategies in time-sequence data domains within electronic health record systems. Results We explore a broad spectrum of methodologies, including statistical models, supervised and unsupervised learning approaches, hybrid frameworks, and state-of-the-art ML-based techniques that collectively advance the precision and scalability of detecting anomalies in complex clinical datasets. In addition to mapping current capabilities, we address the enduring challenges that hinder widespread implementation and provide a forward-looking perspective on the future of anomaly detection in the data-rich landscape of modern healthcare. Summary The advancement in AI-based approaches is reported along with the basic principles of the individual approaches and their applicability. The increased availability of high-quality data, advancements in DL approaches, and enhanced computation power are leading to more frequent adaptation of DL-based approaches. Emerging DL-based approaches that have been adapted in other domains or recently applied in the EHR domain are also discussed in detail. Although DL-based approaches can improve model predictions by incorporating comorbidities, their application is limited in low-frequency data domains (e.g., when the total available data remains in the single digits). Therefore, the user must carefully consider the application based on data availability.

Anomaly detection↗

Comparative Assessment of Data-driven Process Models in Health Information Technology

Process mining for conformance analysis consists of comparing a reference process model against a data-driven process model generated via log files from information technology systems. However, in the absence of a complete reference process model, we found no suggested approaches in the literature to address the need for evaluating process conformance among different healthcare facilities to assess standardization of care. Our goal is to find similarities and dissimilarities in data-driven process models among US Veterans Health Administration (VHA) facilities that can be indicative of patient safety issues. Our hypothesis was that the analysis would not produce statistically significant differences in outcome. We present a unique implementation of conformance analysis in process mining that consists of combining process mining, process mapping and statistical metrics. We illustrate our approach by applying it to the analysis of two clinical radiology order process models generated from healthcare data provided by two similar facilities in the VHA. The comparative assessment showed that about 70% of the orders completed successfully and 30% were not completed due to policy and duplications. Our analysis found a good statistical correlation between both facilities, as the Spearman’s correlation coefficient between facilities for the frequency of cases per total hours was 0.87879, for the frequency of cases by state transition was 0.79702 and for the throughput time per state transition was 0.63582. Additional statistical analyses using the Mann-Whitney U test and the root mean square error both produced values that were not significant. The foregoing approach validated our hypothesis by demonstrating a good statistical correlation of data describing the flow of clinical radiology orders absent a credible reference model. Finding good agreement between both facilities was important in confirming that the clinical orders flow in a similar manner, suggesting standardization of care.

97 MATHEMATICS AND COMPUTING↗

Hazard Detection Detector Cards

This report presents a comprehensive summary of five advanced anomaly detection tools developed and deployed by Oak Ridge National Laboratory in support of the VA’s Health Information Technology modernization. These detectors—Order Path Tracker, Trend Watcher, Pain Pointer, Performance Monitor, and Patient Record Flag Detector—leverage statistical and machine learning methods to monitor workflow disruptions, detect anomalies in care sequences and volumes, identify bottlenecks, and track system-level performance metrics across VistA and Millennium systems. All detectors have been integrated into the Health Data Analytics Platform (HDAP), with most having completed deployment and testing using live data from targeted stations in cardiology and oncology domains. This work enhances VA’s capacity for proactive system surveillance, promotes patient safety, and informs data-driven operational improvements across the EHR ecosystem.

97 MATHEMATICS AND COMPUTING↗

Design of a specialized computer for on-line monitoring of cardiac stroke volume

The design of a specialized analog computer for on-line determination of cardiac stroke volume by means of a modified version of the pressure pulse contour method is presented. The design consists of an analog circuit for computation and a timing circuit for detecting necessary events on the pressure waveform. Readouts of arterial pressures, systolic duration, heart rate, percent change in stroke volume, and percent change in cardiac output are provided for monitoring cardiac patients. Laboratory results showed that computational accuracy was within 3 percent, while animal experiments verified the operational capability of the computer. Patient safety considerations are also discussed.

Webb, J. A., Jr.↗

Pharmacy in a New Frontier - The First Five Years at the Johnson Space Center Pharmacy

A poster entitled "Space Medicine - A New Role for Clinical Pharmacists" was presented in December 2001 highlighting an up-and-coming role for pharmacists at the Johnson Space Center (JSC) in Houston, Texas. Since that time, the operational need for the pharmacy profession has expanded with the administration s decision to open a pharmacy on site at JSC to complement the care provided by the Flight Medicine and Occupational Medicine Clinics. The JSC Pharmacy is a hybrid of traditional retail and hospital pharmacy and is compliant with the ambulatory care standards set forth by the Joint Commission. The primary charge for the pharmacy is to provide medication management for JSC. In addition to providing ambulatory care for both clinics, the pharmacists also practice space medicine. A pharmacist had been involved in the packing of both the Space Shuttle and International Space Station Medical Kits before the JSC Pharmacy was established; however, the role of the pharmacist in packing medical kits has grown. The pharmacists are now full members of the operations team providing consultation for new drug delivery systems, regulations, and patient safety issues. As the space crews become more international, so does the drug information provided by the pharmacists. This presentation will review the journey of the JSC Pharmacy as it celebrated its five year anniversary in April of 2008. The implementation of the pharmacy, challenges to the incorporation of the pharmacy into an existing health-care system, and the current responsibilities of a pharmacist at the Johnson Space Center will be discussed.

Bayuse, Tina↗

Patterns of Care, Tolerability, and Safety of the First Cohort of Patients Treated on a Novel High-Field MR-Linac Within the MOMENTUM Study: Initial Results From a Prospective Multi-Institutional Registry

High-field magnetic resonance-linear accelerators (MR-Linacs), linear accelerators combined with a diagnostic magnetic resonance imaging (MRI) scanner and online adaptive workflow, potentially give rise to novel online anatomic and response adaptive radiation therapy paradigms. The first high-field (1.5T) MR-Linac received regulatory approval in late 2018, and little is known about clinical use, patient tolerability of daily high-field MRI, and toxicity of treatments. Herein we report the initial experience within the MOMENTUM Study (NCT04075305), a prospective international registry of the MR-Linac Consortium.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Efficacy and safety of warfarin in patients with non-valvular atrial fibrillation and CKD G3–G5D

ABSTRACT Background Observational data comparing warfarin with no treatment for patients with non-valvular atrial fibrillation (NVAF) and severely reduced glomerular filtration rate (GFR) are conflicting and randomized controlled trials (RCTs) are lacking. Most studies do not provide information on warfarin treatment quality, making them difficult to compare. Methods This national cohort study investigates the risk of ischaemic stroke and major bleeding during warfarin treatment compared with no oral anticoagulants in patients with NVAF, GFR category 3–5 (G3–G5) or on dialysis (G5D), with kidney transplant recipients excluded, between 2009 and 2018. Data extracted from high-quality Swedish national healthcare registries, including the Swedish Renal Registry, AuriculA—the Swedish national quality registry for atrial fibrillation and anticoagulation—and the Stroke Registry. Results At enrolment of 12 106 patients, 21.4% were G3, 43.5% were G4, 11.6% were G5 and 23.6% were G5D. The mean time in the therapeutic range was 70%. Warfarin compared with no treatment showed a lower risk for ischaemic stroke for G3 {hazard ratio [HR] 0.37 [95% confidence interval (CI) 0.18–0.76]}, G4 [0.53 (0.38–0.74)] and G5D [0.49 (0.30–0.79)] and an increased risk of major bleeding in G4 [HR 1.22 (1.02–1.46)], G5 [1.52 (1.15–2.01)] and G5D [1.23 (1.00–1.51)]. All-cause mortality was more than halved on warfarin compared with no treatment in all GFR categories. Conclusions Warfarin treatment is associated with a lower risk of ischaemic stroke for patients with NVAF and G3, G4 and G5D at the cost of a higher risk of major bleeding for G4–G5D. Existing observational data are conflicting, stressing the need for RCTs on warfarin compared with no treatment in G4–G5D. Awaiting RCTs, it seems reasonable to treat selected patients on dialysis and NVAF with warfarin.

Welander, Frida (ORCID:0000000311117215)↗

COVID-19 vaccination status, side effects, and perceptions among breast cancer survivors: a cross-sectional study in China

Introduction Breast cancer is the most prevalent malignancy in patients with coronavirus disease 2019 (COVID-19). However, vaccination data of this population are limited. Methods A cross-sectional study of COVID-19 vaccination was conducted in China. Multivariate logistic regression models were used to assess factors associated with COVID-19 vaccination status. Results Of 2,904 participants, 50.2% were vaccinated with acceptable side effects. Most of the participants received inactivated virus vaccines. The most common reason for vaccination was “fear of infection” (56.2%) and “workplace/government requirement” (33.1%). While the most common reason for nonvaccination was “worry that vaccines cause breast cancer progression or interfere with treatment” (72.9%) and “have concerns about side effects or safety” (39.6%). Patients who were employed (odds ratio, OR = 1.783, p = 0.015), had stage I disease at diagnosis (OR = 2.008, p = 0.019), thought vaccines could provide protection (OR = 1.774, p = 0.007), thought COVID-19 vaccines were safe, very safe, not safe, and very unsafe (OR = 2.074, p < 0.001; OR = 4.251, p < 0.001; OR = 2.075, p = 0.011; OR = 5.609, p = 0.003, respectively) were more likely to receive vaccination. Patients who were 1–3 years, 3–5 years, and more than 5 years after surgery (OR = 0.277, p < 0.001; OR = 0.277, p < 0.001, OR = 0.282, p < 0.001, respectively), had a history of food or drug allergies (OR = 0.579, p = 0.001), had recently undergone endocrine therapy (OR = 0.531, p < 0.001) were less likely to receive vaccination. Conclusion COVID-19 vaccination gap exists in breast cancer survivors, which could be filled by raising awareness and increasing confidence in vaccine safety during cancer treatment, particularly for the unemployed individuals.

Xu, Yali↗