Clinical Data Repository Research Articles

The incidence and outcome of patients with early cardiovascular complications following intracerebral haemorrhage: An individual patient data pooled analysis from the VISTA database

Abstract Background Early cardiovascular (CV) complications in patients following intracerebral haemorrhage (ICH) is poorly understood. Such incident CV complications could be part of the so-called stroke-heart-syndrome occurring following ICH (SHS-ICH). We investigated the incidence and outcomes of patients with SHS-ICH. Methods Data were sought from the Virtual International Stroke Trials Archive (VISTA), an international repository of clinical trials data. We reviewed relevant adverse events and identified patients based on the incidence of cardiovascular complications within 30 days of post-ICH or ischaemic stroke (acute coronary syndrome [ACS] including acute myocardial injury, heart failure [HF]/left ventricular [LV] dysfunction, atrial fibrillation [AF]/atrial flutter [AFL], other arrhythmia/ ECG abnormalities, and cardio-respiratory arrest [CRA]). We conducted propensity score matching (PSM) to compare the incidence and outcomes of patients with SHS following ICH (SHS-ICH) with patients with SHS following acute ischaemic stroke (AIS). Poor outcome was defined as modified Rankin Scale, mRS ≥2, at 90 days. Results We pooled data from 12,438 participants recruited in acute stroke trials (mean age 68±12 years; 56% male), of which 1,171 (9.4%) were patients with ICH. Of the ICH patients, 150 patients (12.8%) had SHS-ICH. Following PSM, a total of 2,342 patients (1,171 for each of the ICH and AIS cohorts) were analysed. The incidence of SHS was not significantly different in the ICH and AIS cohorts (Table 1). The incidence of AF was significantly lower in patients with ICH compared to patients with AIS (1.5% vs. 4.5%, p<0.0001), despite comparable incidences of other arrhythmia/ECG abnormalities (9% vs. 9%, p=0.9). Multivariate-adjusted analysis found that SHS-ICH was associated with poor outcomes (Table 2, odds ratio, OR 1.08 [95%CI: 1.03-1.16], p=0.04, compared to ICH patients without SHS). Conclusions Stroke-heart syndrome is common and serves as a crucial prognostic marker in patient with ICH, with outcomes similar to SHS patients related to AIS. The development of SHS-ICH was associated with poorer outcomes compared to ICH patients without SHS.

Risk of death in patients with early cardiovascular complications following ischaemic stroke: an individual patient data pooled analysis from the VISTA database

Abstract Background Early cardiovascular complications may occur in patients following ischaemic stroke (stroke-heart-syndrome, SHS). We investigated the risk of death in patients with SHS, and across the SHS manifestations. Methods Data were sought from the Virtual International Stroke Trials Archive (VISTA), an international repository of clinical trials data. We reviewed relevant adverse events and classified patients into two cohorts based on the incidence of cardiovascular complications within 30 days post-stroke (acute coronary syndrome [ACS] including acute myocardial injury, heart failure [HF]/left ventricular [LV] dysfunction, atrial fibrillation [AF]/atrial flutter [AFL], other arrhythmia/ ECG abnormalities, and cardio-respiratory arrest [CRA]), i.e. those with SHS and those with stroke-only (without SHS). Using Cox proportional hazards model, we evaluated the 90-day risk of death trajectories associated with SHS. We also compared the 90-day risk of death across SHS manifestations excluding CRA, using multivariate analysis. Results Among 15,054 patients with ischaemic stroke (mean age 72±11 years; 55% male), 1,787 (11.8%; 95% confidence interval [CI]: 11.3-12.3, Table 1) developed SHS, with incidence peaked at day 3 post-stroke (interquartile range: 2-5). Other arrhythmia/ECG abnormalities were the most prevalent (6.5%; 95%CI: 6.1-6.9), followed by AF/AFL, HF/LV dysfunction, ACS/acute myocardial injury, and CRA. Patients who developed SHS between 10-30 days post-stroke had significantly higher risks of death compared to those with SHS within the first 0-3 days (adjusted hazard ratio [HR]: 2.13 [1.57-2.89]). In the multivariate-adjusted analysis which includes 13 background factors such as age and sex, SHS manifested as ACS/acute myocardial injury and HF/LV dysfunction were associated with highest risk of death within 90-day post-stroke (adjusted hazard ratio [HR] [95% CI], HR 2.13 (1.08-4.18) and HR 2.28 (1.42-3.66), respectively, Figure 1). Conclusions Stroke-heart syndrome is associated with high risk of death, with greater risk observed with the delayed SHS onset. Among the SHS manifestations, ACS/acute myocardial injury and HF/LV dysfunction were associated with the highest risk of death post-stroke.Figure 1

The Epidemiology of Pediatric Shoulder Dislocations in the United States.

Shoulder dislocations are the most common of all major joint dislocations and are a frequent cause of emergency department (ED) presentations. While the epidemiology of shoulder dislocations has been characterized in adults, it has not yet been done for children in the United States. The primary goal of this study was to calculate the incidence rate of pediatric shoulder dislocations in the United States. Secondary goals were to characterize the demographic information of children with shoulder dislocations as well as trends in management. The US Collaborative Network in TriNetX, a network of clinical data repositories containing patient data from over 100,000,000 unique individuals within the United States, was queried for patients younger than 18 years old diagnosed with shoulder dislocation from 2014 to 2024 using ICD codes. The demographic details were then extracted from the data set, and treatment approaches were determined by CPT coding. Over the past 10 years, there were 16,460 pediatric and adolescent patients diagnosed with a first-time shoulder dislocation in either an ED or ambulatory clinic. The overall incidence rate was 60.31 per 100,000 patients, while the incidence rate was 116.61 per 100,000 patients presenting in the ED and 33.95 per 100,000 patients presenting in ambulatory clinics that were under the age of 18 years. Most patients were male (73%), White (59%), and came from the southeastern region of the United States (36%). The most common treatment was a closed reduction (25%), followed by arthroscopic surgery (17%). The number of annual shoulder dislocations has increased over the past decade without an increase in the number of patients undergoing surgical treatment. There remains a high incidence rate of shoulder dislocations in the pediatric population of the United States. Despite evidence that early surgical treatment of shoulder dislocations offers improved outcomes, nonoperative treatment continues to be the most common modality without any increase in the percentage of patients undergoing surgical treatment. Level IV-descriptive epidemiological analysis.

Stroke-heart syndrome and early mortality in patients with acute ischaemic stroke using hierarchical cluster analysis: An individual patient data pooled analysis from the VISTA database.

The patient clinical phenotypes at particularly high risk for early cardiac complications after a recent acute ischaemic stroke (AIS), that is, stroke-heart syndrome (SHS), remain poorly defined. We utilised hierarchical cluster analysis to identify specific phenotypic profiles associated with this risk. We gathered data on patients with AIS from the Virtual International Stroke Trials Archive, a global repository of clinical trial data. We examined cardiac complications within 30 days post-stroke, including acute coronary syndrome, heart failure, arrhythmias and cardiorespiratory arrest. We employed hierarchical cluster analysis to define distinct phenotypic risk profiles. The incidence/risk of SHS and 90-day mortality were compared across these profiles. We included 12,482 patients (mean age 69 ± 12 years; 55% male), yielding five phenotypes: Profile 1 ('elderly and AF'), Profile 2 ('young and smoker'), Profile 3 ('young'), Profile 4 ('cardiac comorbidities') and Profile 5 ('hypertension with atherosclerotic comorbidities'). Profiles 4 and 1 exhibited the highest risk for SHS (adjusted HR (95% CI): 2.01 (1.70-2.38) and 1.26 (1.05-1.51), respectively, compared to Profile 3), while Profiles 5 and 2 showed moderate risk and Profile 3 had the lowest risk. Although Profiles 1 and 4 were at the highest risk for most SHS presentations, Profile 5 had the highest risk for cardiorespiratory arrest (adjusted HR (95% CI): 2.99 (1.22-7.34)). The 90-day mortality risk was stratified by phenotype, with the highest risk observed in Profiles 5, and 4. Hierarchical cluster analysis effectively identified phenotypes with the highest risk of SHS and early mortality in patients with AIS.

Incidence and Outcomes of Patients With Early Cardiac Complications After Intracerebral Hemorrhage: A Report From VISTA.

The incidence and outcomes of early cardiac complications in patients with intracerebral hemorrhage (ICH) are poorly understood. These cardiac complications may be part of the so-called stroke-heart syndrome in patients with ICH. We investigated this issue in an individual patient data pooled analysis from an international repository of clinical trial data. We used the Virtual International Stroke Trials Archive to investigate the incidence of cardiac complications within 30 days post-ICH or acute ischemic stroke (AIS). These complications included acute coronary syndrome encompassing myocardial injury, heart failure/left ventricular dysfunction, atrial fibrillation/atrial flutter, other arrhythmia/ECG abnormalities, and cardiorespiratory arrest. We used propensity score matching to compare the incidence of patients with stroke-heart syndrome in patients with ICH with those following AIS. Factors associated with 90-day mortality were evaluated using multivariate logistic regression analysis in the ICH cohort. We pooled data from 8698 participants recruited in acute stroke trials (mean age, 68±12 years; 56% male), of whom 914 (11%) were patients with ICH. Among the patients with ICH, 123 (13%) had stroke-heart syndrome in patients with ICH. Following propensity score matching, a total of 1828 patients (914 for each of the cohorts) were analyzed. While the overall incidence of cardiac events tended to be lower in the ICH group compared with the AIS group (the cumulative incidence freedom from the event, 86.3% [95% CI, 84.1-88.6] versus 83.6% [95% CI, 81.2-86.0]; P=0.100), the incidences cardiac events other than atrial fibrillation/atrial flutter were comparable between the 2 matched groups. The incidence of atrial fibrillation/atrial flutter was significantly lower in the ICH group than in the AIS group (P<0.001). The multivariate-adjusted analysis found that stroke-heart syndrome in patients with ICH was associated with 90-day mortality (adjusted odds ratio, 1.12 [95% CI, 1.06-1.19]; P<0.001). Cardiac events are common and negatively affect prognosis in patients with ICH, just as seen in AIS.

Sex-based differences in treatment approaches and outcomes among patients with mpox: Limitations of real-world data.

Limited data on females with mpox restricts understanding of potential sex-based disparities in treatment and outcomes. This study aims to investigate these differences using administrative claims and clinical data repositories. We retrospectively analyzed adults diagnosed with mpox using TriNetX, stratifying cohorts by sex. The primary outcome included urgent care, emergency room, and hospitalization visits, with secondary outcomes including clinical findings, vaccination, and treatment. Among 2011 cases, 90% were male. Males were older, more likely to identify as Hispanic or Latino, and had higher HIV prevalence and sexually transmitted infection rates. Hospitalization rates were low for both groups, with similar healthcare utilization. However, males received fewer opioid analgesics, glucocorticoids, and antiemetics versus females. Vaccination and tecovirimat use were minimal in both groups. Addressing sex disparities in mpox treatment and outcomes is crucial, but existing data sources like administrative claims and clinical data repositories pose limitations.

Converting Entity-Attribute-Value Data Sources to OMOP's CDM: Lessons Learned.

Clinical data repositories often use entity-attribute-value (EAV) data models. To be valuable for secondary use, these health data can be transformed to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The present paper describes the lessons learned from such an endeavour based on the concept of registering transformation functions on source data elements. We further provide future work directions for follow-up projects.

The Efficacy of Acupuncture Therapy in the Management of Dyspnea and Other Symptoms Associated with Heart Failure: A Consolidated Review of Trial Data.

Acupuncture has been used for pain management for thousands of years. However, it is largely unclear whether this therapeutic approach can effectively reduce heart failure-associated symptoms, including dyspnea. The hypothesis posited in this study was that acupuncture does indeed aid in the management of such symptoms and was motivated by the following statistics that establish a requisite need for efficient management of dyspnea to improve patient outcomes with heart failure. In 2020, an estimated 6.2 million adults in the USA had a heart failure diagnosis; in 2018, 379,800 death certificates reported heart failure; and the national cost of heart failure in 2012 was approximately USD 30.7 billion. The methodology employed to conduct this study involved review of trial data extracted from review of papers pertaining to acupuncture, symptoms of heart failure, and dyspnea, from academic and clinical data repositories subject to various inclusion and exclusion criteria. Of the initial set of 293 studies identified, the resulting inclusion set comprised 30 studies. The analysis conducted revealed that the highest frequency of combined acupuncture points prescribed for the foregoing search criteria were as follows: BL13, BL23, LU9, LU5, Dingchuan, LI4, PC6, and HT7. A meta-analysis of combined pooled p values for the studies revealed that acupuncture does aid in the management of symptoms of dyspnea and heart failure, subject to various limitations including but not limited to heterogeneity inherent between the studies in the inclusion set that were analyzed. Such limitations underscore the need to restrict generalizations from the conclusions of this study. The impact and novelty of this research study is its attempt to target the apparent paucity of literature that focuses on the management of dyspnea specifically in the context of heart failure with acupuncture and to bridge the gap of the application of acupuncture research on dyspnea to the cardiovascular context of heart failure. Notwithstanding the meta-analysis undertaken under this review study, further statistical analysis and a pilot study are warranted to consolidate or nullify the results of the research.

Cholesteatoma in the pediatric aerodigestive population

ObjectivesTo report the prevalence of cholesteatoma and related comorbidities in pediatric aerodigestive patients requiring tracheostomy or airway reconstruction procedures. To use study findings to inform clinical management of these complex patients. MethodsA repository of clinical data drawn from our institution's electronic medical records was queried to identify airway reconstruction (airway) and complex hospital control (control) patient cohorts. Retrospective chart review was then performed to investigate the occurrence of cholesteatoma and related pathologies in these patients, as well as clinical management. ResultsThe prevalence of cholesteatoma in airway and control patients was 6/374 (1.60 %) and 35/30,565 (0.11 %), respectively. The relative risk of cholesteatoma diagnosis in airway patients was 14.01 (95 % CI 6.06–32.14). Airway patients were more likely than control patients to have pressure equalization tube history (relative risk 3.25, 95 % CI 2.73–3.82). Age at cholesteatoma diagnosis and first surgical intervention was younger in airway compared to control patients (5.43 vs. 8.33, p = 0.0182, and 6.07 vs. 8.82, p = 0.0236). However, time from diagnosis to intervention and extent of surgery were similar between the groups. ConclusionThis is the first study to investigate the prevalence of cholesteatoma in the pediatric aerodigestive population. The relative risk of cholesteatoma diagnosis was found to be 14 times higher in patients with tracheostomy or airway reconstruction history. Underlying eustachian tube and palatal dysfunction are likely contributing factors to the elevated risk. Additionally, cholesteatoma in this population was diagnosed and required surgical intervention at a younger age, which may suggest a more aggressive disease course. Providers should maintain a high degree of suspicion for cholesteatoma in this complex population.

Deployment of a Phenotypic Characterization System for Effective Identification of the Onset of Asthma Disease

Background Essentially, machine learning techniques help with clinical decision-making by forecasting prediction results based on recent and historical data, which are frequently found in carefully chosen clinical data repositories. In order to uncover hidden patterns in the data, machine learning applies sophisticated analytical techniques that conduct an exploratory analysis while constructing prediction models to support clinical judgment. Objective To effectively identify asthmatics in two distinct cohorts representing India's rural and urban populations by adopting a phenotypic characterization approach. Methods Cross-sectional and categorical in design, the data represent the two populations, with clinical history information emphasizing clinical symptoms and patterns defining the condition. The method adopts a hybrid approach since it uniquely blends the unsupervised and supervised learning techniques to explore the advantages of both. The clustering data emphasizing the phenotypic characteristics of asthma is input to the classifier, and the performance of the classifier was continuously monitored for significant improvement in the results. Results Asthma disease outcome predictions made by the hybrid decision support system were quite accurate, with classification accuracy reaching up to 85.1% and 95.3% for the two datasets, respectively. Conclusion Since asthma is a heterogeneous disease with multiple subtypes, employing clustering information in the form of cluster evaluation scores as an input parameter to the classifiers can effectively predict disease outcomes.

Exemplifying practice-based research: the influence of age on myopia progression

ABSTRACT Clinical relevance The electronic storage of patient records and modern-day search engines present private practitioners with a unique opportunity to extract valuable data for investigative research purposes. However, practitioners seldom harness this resource and consequently a vast repository of clinical data remains largely unexplored. Background This study, based on real-world data from an optometric practice, stands as an example of how clinicians can actively contribute to research. In doing so it underscores the role played by age in determining the rate of natural myopia progression. Methods A retrospective data analysis of the refractive status, age and optical correction type of participants, was conducted over six years. Forty-four participants were recruited (25 contact lens and 19 spectacle wearers), with a presenting age varying from 5 to 20 years (median, 11 years). Non-cycloplegic, monocular foveal refractions were completed using a ShinNippon open-field autorefractor, corroborated with subjective refraction. The mean spherical equivalent refractive error was calculated for the participants’ initial visit (baseline measure) and for a six-year follow-up visit (progression measure), with myopia progression defined as the difference between these measures. Statistical analyses were computed using Decision Tree Analysis, with a significance level set at 95%. Results The participant age at first visit exerted a significant influence on natural myopia progression over the assessment period (F 1,42 = 17.11, p < 0.001). Individuals aged ≤ 10 years had approximately twice the myopic progression (mean, −2.27 D) of those aged > 10 years (mean, −1.13 D). Neither degree of myopia at the initial visit nor optical correction type had a significant effect on progression (p > 0.05). Conclusions Utilizing the advantage of small real-world data samples, the benefit of research by private practitioners was demonstrated, providing evidence that the age at which a child first presents for an eye examination is highly influential in determining their rate of myopia progression.

Discontinuation and nonpublication of clinical trials in orthopaedic oncology

BackgroundDespite the pivotal role of clinical trials in advancing orthopaedic oncology knowledge and treatment strategies, the persistent issues of trial discontinuation and nonpublication are significant problems. This study conducted an analysis examining clinical trial discontinuation rates, associations between intervention types and discontinuation/nonpublication, and the role of funding, enrollment size, and their implications for trial success and completion.MethodsThis study, conducted on May 1, 2023, utilized a cross-sectional design to comprehensively analyze phase 3 and 4 randomized controlled trials within the realm of orthopaedic oncology. We specifically incorporated Phase 3 and 4 trials as they are designed to evaluate prolonged outcomes in human subjects and are more likely to reach publication. Study characteristics of interest included the intervention utilized in the clinical trial, presence of funding, whether the trial was published, completed, and trial enrollment size. The investigation involved an examination of ClinicalTrials.gov, a prominent online repository of clinical trial data managed by the National Library of Medicine of the USA. Descriptive statistics and multivariate logistic regressions were used to determine statistical significance.ResultsAmong the cohort of 130 trials, 19.2% were prematurely discontinued. Completion rates varied based on intervention type; 111 pharmaceutical trials demonstrated a completion rate of 83.8%, whereas 19 non-pharmaceutical trials exhibited a completion rate of 8.0% (P < .001). Surgical trials, totaling 10, showed a completion rate of 90%. The overall trial publication rate was 86.15%, with pharmaceutical interventions achieving a publication rate of 91.96%. Larger-scale trials (≥ 261 participants) emerged as a protective factor against both discontinuation (Adjusted Odds Ratio [AOR]: 0.85, 95% Confidence Interval [CI] 0.42–0.95) and nonpublication (AOR: 0.19, 95% CI 0.13–.47), compared to smaller-scale trials.ConclusionThis study accentuates the heightened vulnerability of non-pharmaceutical interventions and trials exhibiting lower rates of enrollment to the issues of discontinuation and nonpublication. Moving forward, the advancement of clinical trials necessitates a concerted effort to enhance trial methodologies, especially concerning nonpharmaceutical interventions, along with a meticulous refinement of participant enrollment criteria.

Robot assisted Laparoscopic Cholecystectomy- A Comparative study

Background- Robotic surgery has recently grown in acceptance and usefulness in general surgery, and it may offer superior results to laparoscopic surgery in some gastrointestinal operations. Objectives- To assess if the use of robot assistance during laparoscopic cholecystectomy is warranted when compared to traditional laparoscopic cholecystectomy. Methods- It was a retrospective record based study. All patients undergoing robotic or laparoscopic cholecystectomy between 2019 and 2022 at a single academic medical center were captured using institutional data. A total of 110 robotic surgeries were done and 1200 Laparoscopic cholecystectomies was done during the study period. The bulk of cases were primarily handled by two acute care general surgeons, who also conducted robotic and laparoscopic cholecystectomies. The institutional Clinical Data Repository provided the financial information. The study was approved by Institutional Ethics Committee. Age, sex, race, body mass index (BMI), and comorbid conditions of the patient were examined prior to surgery. SPSS was used for analysis. Results- A total of 1310 patients were identified who underwent robotic or laparoscopic cholecystectomy between 2019 and 2022 among them Robotic-assisted approach was used in 9.1% (n = 110) of cases. There were no demographic differences in age, sex, race, and body mass index (BMI). Type II diabetes mellitus, hypertension, and CHF disease were statistically significantly different between groups. Mean age (Robotic: 41 [29-56] vs. Laparoscopic: 43 [30-54] years, p = 0.11) and BMI (Robotic: 28.4 [26.6-32.4] vs. Laparoscopic: 29.2 [27.5-33.4]) were similar between groups. both operative duration was greater and hospital cost were greater in robotic-assisted cholecystectomy and it was statistically significant (p&lt;0.05), but hospital duration of stay and 90-day related readmission rates were less in robotic-assisted cholecystectomy which was significant; 30-day readmission rates were similar between both groups. Conclusion- When compared to laparoscopic cholecystectomy, robotic cholecystectomy has longer operating times and higher hospital costs, but it is also related with shorter hospital stays and a lower readmission rate within 90 days after the index procedure. Before exploring robotic cholecystectomy, hospitals and surgeons must weigh the enhanced clinical outcomes against the time and money necessary.

Use of a Data Repository to Identify Delirium as a Presenting Symptom of COVID-19 Infection in Hospitalized Adults: Cross-Sectional Cohort Pilot Study.

Delirium, an acute confusional state highlighted by inattention, has been reported to occur in 10% to 50% of patients with COVID-19. People hospitalized with COVID-19 have been noted to present with or develop delirium and neurocognitive disorders. Caring for patients with delirium is associated with more burden for nurses, clinicians, and caregivers. Using information in electronic health record data to recognize delirium and possibly COVID-19 could lead to earlier treatment of the underlying viral infection and improve outcomes in clinical and health care systems cost per patient. Clinical data repositories can further support rapid discovery through cohort identification tools, such as the Informatics for Integrating Biology and the Bedside tool. The specific aim of this research was to investigate delirium in hospitalized older adults as a possible presenting symptom in COVID-19 using a data repository to identify neurocognitive disorders with a novel group of International Classification of Diseases, Tenth Revision (ICD-10) codes. We analyzed data from 2 catchment areas with different demographics. The first catchment area (7 counties in the North-Central Florida) is predominantly rural while the second (1 county in North Florida) is predominantly urban. The Integrating Biology and the Bedside data repository was queried for patients with COVID-19 admitted to inpatient units via the emergency department (ED) within the health center from April 1, 2020, and April 1, 2022. Patients with COVID-19 were identified by having a positive COVID-19 laboratory test or a diagnosis code of U07.1. We identified neurocognitive disorders as delirium or encephalopathy, using ICD-10 codes. Less than one-third (1437/4828, 29.8%) of patients with COVID-19 were diagnosed with a co-occurring neurocognitive disorder. A neurocognitive disorder was present on admission for 15.8% (762/4828) of all patients with COVID-19 admitted through the ED. Among patients with both COVID-19 and a neurocognitive disorder, 56.9% (817/1437) were aged ≥65 years, a significantly higher proportion than those with no neurocognitive disorder (P<.001). The proportion of patients aged <65 years was significantly higher among patients diagnosed with encephalopathy only than patients diagnosed with delirium only and both delirium and encephalopathy (P<.001). Most (1272/4828, 26.3%) patients with COVID-19 admitted through the ED during our study period were admitted during the Delta variant peak. The data collected demonstrated that an increased number of older patients with neurocognitive disorder present on admission were infected with COVID-19. Knowing that delirium increases the staffing, nursing care needs, hospital resources used, and the length of stay as previously noted, identifying delirium early may benefit hospital administration when planning for newly anticipated COVID-19 surges. A robust and accessible data repository, such as the one used in this study, can provide invaluable support to clinicians and clinical administrators in such resource reallocation and clinical decision-making.

1359. Understanding Data Completeness from Sites Participating in the N3C Limited Data Set

Abstract Background Numerous data sources such as registries utilize data collected across multiple sites, typically across a geographic region. Understanding the degree to which individual sites contribute core data components such as diagnoses, treatments, procedures, and measurements, is an essential step when conducting analyses using a multi-site database. The National COVID Cohort Collaborative (N3C) is the largest repository of deidentified clinical data from 18.9 million patients tested for or diagnosed with COVID-19 in the United States, and has been cited in over 150 publications, preprints, and presentations. Data is systematically collected across electronic health records from multiple sites and harmonized into the OMOP Common Data Model (CDM). Here, we aim to describe data completeness from participating sites using the N3C Level 3 Limited Data Set. Methods Key OMOP CDM data tables (measurement, drug_exposure, condition_occurrence, and procedure_occurrence) from two N3C data releases six months apart (August 2022 and February 2023) were assessed. A site was considered to contribute to a key data table if a threshold of at least 1,000 records and lag of no more than 5 months within 6 months prior to the data release date through the data release was observed for that site. Records with dates after the data release date or with missing dates were not included. The proportion of sites with data in at least one key table and data in all key tables in the August 2022 and February 2023 data releases was determined. Results Of the 77 sites identified in the N3C Limited Data Set in August 2022, 76.6%-83.1% had data in at least one key table and 75.3% (N=58) had data in all four key tables. A drop of 6.8% in the number of sites with data in all 4 key tables was observed in the February 2023 data release. The condition_occurrence table was most impacted by site attrition (12.5%) between these data releases, while the drug_exposure was the least impacted (3.2%). Conclusion We observed a minor heterogeneity and a high proportion of sites contributing key data tables through the two N3C data releases under investigation. Assessing such sites characteristics during the study design phase may be an essential step when designing high-quality real-world studies that utilize multi-site data. Disclosures Yuval Koren, MSc, AstraZeneca: Grant/Research Support Daniel Poscover, MBA, AstraZeneca: Grant/Research Support Charles Barr, MD, MPH, AstraZeneca: Grant/Research Support

2232. Comparison of Empiric Vancomycin Prescribing in Response to Gram Positive Cocci Alerts on Blood Cultures Between Primary and Overnight Physicians on General Medicine Services: A Retrospective Study

Abstract Background Blood culture contamination is associated with unnecessary antibiotic use, increased length of stay, and increased costs. Assessing the likelihood of true bacteremia versus contamination requires consideration of clinical context and microbiologic data. This may be more difficult for covering physicians overnight, who typically cover more patients and may not know patients’ clinical history as well. We compared rates of vancomycin (VAN) initiation in response to microbiology alerts for gram-positive cocci (GPC) in blood cultures during primary team shifts versus overnight. Methods We queried the University of Virginia Clinical Data Repository for blood culture results positive for GPC from 07/01/2021 to 12/30/2022 in inpatient general medicine patients. Cultures were stratified by time of the initial positive gram stain alert, which is called as a critical result to the team. All new positive blood cultures are run on a rapid molecular diagnostic (ePlex GenMark Diagnostics) with speciation results passively entered into the chart 2 hours after gram stain. Results were excluded if the patient was already on VAN or daptomycin at the time of gram stain or if the gram stain resulted during hours when the physician coverage (primary vs covering) was not consistent. The primary outcome was the rate of VAN initiation within 2 hours of gram stain with GPCs. Secondary outcomes were number of repeat blood cultures, length of stay (LOS), and incidence of acute kidney injury (AKI). Results 320 instances of positive blood cultures were reviewed. 141 were excluded. Of 179 included instances, there was no significant difference in VAN initiation by overnight physicians compared to primary teams (21% vs 26%; p=0.418). There was no significant difference in repeat cultures or incidence of AKI. Comparison of primary and overnight physicians Blood culture speciation Conclusion There was no difference in VAN use, repeat blood cultures, or AKI when positive gram stain alerts were received by overnight physicians versus primary teams. Stewardship interventions targeting VAN prescribing in the setting of a rapid diagnostic workflow may not need to be specifically adapted to covering physicians or teams. Disclosures Amy Mathers, MD, D(ABMM), Merck: Advisor/Consultant

5-lead 3D-vectorcardiography differentiates between high and low cardiovascular risk profiles in patients with suspected or know coronary heart disease

Abstract 5-lead 3D-vectorcardiography (3D-VCG), including a dorsal electrode with ensemble of artificial neural networks (ANN) offers additional information over standard 12-lead electrocardiography (ECG) in the detection of cardiac ischaemia. Artificial Intelligence (AI) and access to a massive global clinical data repository have the potential to boost the performance of VCG beyond conventional techniques. VCG offers ease-of-use at rest and is therefore a promising candidate for becoming a new screening tool for coronary artery diseases (CAD). We, thus, tested the hypothesis of 3D-VCG being able to differentiate between patients with lower and high risk of cardiovascular disease (CVD) and identify those requiring coronary interventions. In this exploratory study, we analysed patients in a national multicentre trial. Patients were recruited from general cardiologists’ praxis and radiologist centre with patients referred for further diagnosis of suspected or confirmed CVD. Based on the Perfusion (P)-Factor of the 5-lead 3D- vectorcardiography, including 731 parameters, e.g., QRS-T angle and in-house features calculated in time and frequency domains, such as beat moments a P-Index is calculated. Based on the P-Index, patients were either classified as high, medium, or low risk for CVD (medium + high defined as high CVD-risk). Confirmation of CAD was performed according to the practitioners’ discretion blinded to the P-Index. Number of risk factors (mod. PROCAM score) were compared between the high- and low-risk group using an independent t-test. The 468 patients in this sample (m:w 61:39, age: 66 [40-87] years) showed 3.6 [0 - 7] CVRF, 16% had arrhythmias or conduction disturbances (AF, PM, BBB), 24% pts. had consecutive PCI or CABG. 62% were classified as low while 38% were classified as high risk for CVD by the P-Index. Number of cardiovascular risk factors was significantly higher in the high-risk CVD-group as defined by P-Index compared to low CVD-risk (4.0 [3.0 – 5.0] vs. 3.5 [2.0 – 4.0], p &amp;lt; 0.05). P-Index differentiated between suspected CVD with or without consequent PCI or CABG (Chi2 = 4.02, p&amp;lt;0.05). The AI-based 3D-VCG is an innovative diagnostic tool that can help determine a patient's cardiovascular risk profile in resting condition for clinical and research purposes. Furthermore, the P-Index identified those with significant stenoses in need for coronary intervention and may thus be a further scalable screening method to differentiate patients with consequent interventional approach or need for risk modification. These preliminary data will have to be confirmed in a prospective, large-scale performance study to verify the diagnostic accuracy.

Medical Informatics Operating Room Vitals and Events Repository (MOVER): a public-access operating room database.

Artificial intelligence (AI) holds great promise for transforming the healthcare industry. However, despite its potential, AI is yet to see widespread deployment in clinical settings in significant part due to the lack of publicly available clinical data and the lack of transparency in the published AI algorithms. There are few clinical data repositories publicly accessible to researchers to train and test AI algorithms, and even fewer that contain specialized data from the perioperative setting. To address this gap, we present and release the Medical Informatics Operating Room Vitals and Events Repository (MOVER). This first release of MOVER includes adult patients who underwent surgery at the University of California, Irvine Medical Center from 2015 to 2022. Data for patients who underwent surgery were captured from 2 different sources: High-fidelity physiological waveforms from all of the operating rooms were captured in real time and matched with electronic medical record data. MOVER includes data from 58 799 unique patients and 83 468 surgeries. MOVER is available for download at https://doi.org/10.24432/C5VS5G, it can be downloaded by anyone who signs a data usage agreement (DUA), to restrict traffic to legitimate researchers. To the best of our knowledge MOVER is the only freely available public data repository that contains electronic health record and high-fidelity physiological waveforms data for patients undergoing surgery. MOVER is freely available to all researchers who sign a DUA, and we hope that it will accelerate the integration of AI into healthcare settings, ultimately leading to improved patient outcomes.

Russian-language repository of the open clinical data “SibMED Data Clinical Repository”

The global digitalization has become one of the most significant challenges in the field of medicine and healthcare. The rapid development of digital technologies determines the growing demand for constant access to big data in real time Their use is in need for research and technological projects in the sphere of artificial intelligence technologies development. Siberian State Medical University developed the first Russian-language repository of clinical data “SibMed Data Clinical Repository” (https://dataset.ssmu.ru/). The article describes the structure, functions of the repository, and perspectives of its use.

Older adults (OA) in clinical trials: Where are they? Representation of OA in clinical trials conducted at the national cancer institute (NCI) clinical center.

e18517 Background: Clinical trials are a significant source of evidence for diagnostic and management strategies in cancer patients. Diversity, equity, and inclusion are necessary to provide access to clinical trials and improve care. Despite the increase of OA in the United States (US), OA are still under-represented in clinical trials, with a lack of information on clinical outcomes and safety. The NCI provides oncologic care on research studies conducted at the Clinical Center (CC), the research hospital of the National Institutes of Health (NIH) where third-party payers are neither notified nor invoiced for treatments received. Participants come from all over the US and are primarily referred by their primary oncologists. We sought to evaluate the participation of OA in clinical trials at the NCI-CC. Methods: In this retrospective analysis, OA were defined as participants aged ≥65 years. The demographic data of OA enrolled from 2005 to 2019 were retrieved from the Biomedical Translational Research Information System (BTRIS), the NIH clinical research data repository. Data on the incidence of new cancer diagnoses in the US population for the same period (2005-2019) were obtained from the Surveillance, Epidemiology, and End Results (SEER) program. We compared the proportions of OA enrolled in NCI-CC clinical trials with the corresponding data from SEER program. We further stratified the OA into four age subcategories: from 65 to 69, from 70 to 74, from 75 to 79, and older than 80 years of age. No inferential statistical analyses were performed. Results: A total of 37,326 participants were enrolled from 2005 to 2019 on NCI-CC clinical trials. The number of OA = 7,934 (21.3%). According to the SEER program, 11,017,070 people were diagnosed with cancer from 2005 to 2019, and 5,971,607 (54.2%) were OA. Notably, the proportions of OA enrolled in NCI-CC was lower than the SEER data in all the subcategories. Patients ≥75 years accounted for the most under-represented (Table). Conclusions: OA are under-represented in clinical trials conducted at the NCI-CC from 2005 to 2019, emphasizing the need to “geriatricize” clinical trials. Adaptations of trial design such as expansion of eligibility criteria, utilization of geriatric assessment tools, and inclusion of OA-specific enrollment targets may reduce barriers to enrollment. Outreach initiatives to the oncology community to reinforce the need for increased referral of OA along with incorporation of telehealth for trial screening and assessments could also be considered to expand enrollment and increase the evidence base to guide treatment of OA with cancer. [Table: see text]