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  • 1
    In: Critical Care Medicine, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. 12 ( 2023-12), p. 1802-1811
    Abstract: To develop the International Cardiac Arrest Research (I-CARE), a harmonized multicenter clinical and electroencephalography database for acute hypoxic-ischemic brain injury research involving patients with cardiac arrest. DESIGN: Multicenter cohort, partly prospective and partly retrospective. SETTING: Seven academic or teaching hospitals from the United States and Europe. PATIENTS: Individuals 16 years old or older who were comatose after return of spontaneous circulation following a cardiac arrest who had continuous electroencephalography monitoring were included. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: Clinical and electroencephalography data were harmonized and stored in a common Waveform Database-compatible format. Automated spike frequency, background continuity, and artifact detection on electroencephalography were calculated with 10-second resolution and summarized hourly. Neurologic outcome was determined at 3–6 months using the best Cerebral Performance Category (CPC) scale. This database includes clinical data and 56,676 hours (3.9 terabytes) of continuous electroencephalography data for 1,020 patients. Most patients died ( n = 603, 59%), 48 (5%) had severe neurologic disability (CPC 3 or 4), and 369 (36%) had good functional recovery (CPC 1–2). There is significant variability in mean electroencephalography recording duration depending on the neurologic outcome (range, 53–102 hr for CPC 1 and CPC 4, respectively). Epileptiform activity averaging 1 Hz or more in frequency for at least 1 hour was seen in 258 patients (25%) (19% for CPC 1–2 and 29% for CPC 3–5). Burst suppression was observed for at least 1 hour in 207 (56%) and 635 (97%) patients with CPC 1–2 and CPC 3–5, respectively. CONCLUSIONS: The I-CARE consortium electroencephalography database provides a comprehensive real-world clinical and electroencephalography dataset for neurophysiology research of comatose patients after cardiac arrest. This dataset covers the spectrum of abnormal electroencephalography patterns after cardiac arrest, including epileptiform patterns and those in the ictal-interictal continuum.
    Type of Medium: Online Resource
    ISSN: 0090-3493
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 197890-1
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  • 2
    In: Critical Care Explorations, Ovid Technologies (Wolters Kluwer Health), Vol. 3, No. 5 ( 2021-05), p. e0402-
    Abstract: Acute respiratory failure occurs frequently in hospitalized patients and often begins outside the ICU, associated with increased length of stay, cost, and mortality. Delays in decompensation recognition are associated with worse outcomes. Objectives: The objective of this study is to predict acute respiratory failure requiring any advanced respiratory support (including noninvasive ventilation). With the advent of the coronavirus disease pandemic, concern regarding acute respiratory failure has increased. Derivation Cohort: All admission encounters from January 2014 to June 2017 from three hospitals in the Emory Healthcare network (82,699). Validation Cohort: External validation cohort: all admission encounters from January 2014 to June 2017 from a fourth hospital in the Emory Healthcare network (40,143). Temporal validation cohort: all admission encounters from February to April 2020 from four hospitals in the Emory Healthcare network coronavirus disease tested (2,564) and coronavirus disease positive (389). Prediction Model: All admission encounters had vital signs, laboratory, and demographic data extracted. Exclusion criteria included invasive mechanical ventilation started within the operating room or advanced respiratory support within the first 8 hours of admission. Encounters were discretized into hour intervals from 8 hours after admission to discharge or advanced respiratory support initiation and binary labeled for advanced respiratory support. Prediction of Acute Respiratory Failure requiring advanced respiratory support in Advance of Interventions and Treatment, our eXtreme Gradient Boosting-based algorithm, was compared against Modified Early Warning Score. Results: Prediction of Acute Respiratory Failure requiring advanced respiratory support in Advance of Interventions and Treatment had significantly better discrimination than Modified Early Warning Score (area under the receiver operating characteristic curve 0.85 vs 0.57 [test], 0.84 vs 0.61 [external validation] ). Prediction of Acute Respiratory Failure requiring advanced respiratory support in Advance of Interventions and Treatment maintained a positive predictive value (0.31–0.21) similar to that of Modified Early Warning Score greater than 4 (0.29–0.25) while identifying 6.62 (validation) to 9.58 (test) times more true positives. Furthermore, Prediction of Acute Respiratory Failure requiring advanced respiratory support in Advance of Interventions and Treatment performed more effectively in temporal validation (area under the receiver operating characteristic curve 0.86 [coronavirus disease tested], 0.93 [coronavirus disease positive] ), while achieving identifying 4.25–4.51× more true positives. Conclusions: Prediction of Acute Respiratory Failure requiring advanced respiratory support in Advance of Interventions and Treatment is more effective than Modified Early Warning Score in predicting respiratory failure requiring advanced respiratory support at external validation and in coronavirus disease 2019 patients. Silent prospective validation necessary before local deployment.
    Type of Medium: Online Resource
    ISSN: 2639-8028
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 3
    In: Critical Care Medicine, Ovid Technologies (Wolters Kluwer Health), Vol. 48, No. 2 ( 2020-02), p. 210-217
    Abstract: Sepsis is a major public health concern with significant morbidity, mortality, and healthcare expenses. Early detection and antibiotic treatment of sepsis improve outcomes. However, although professional critical care societies have proposed new clinical criteria that aid sepsis recognition, the fundamental need for early detection and treatment remains unmet. In response, researchers have proposed algorithms for early sepsis detection, but directly comparing such methods has not been possible because of different patient cohorts, clinical variables and sepsis criteria, prediction tasks, evaluation metrics, and other differences. To address these issues, the PhysioNet/Computing in Cardiology Challenge 2019 facilitated the development of automated, open-source algorithms for the early detection of sepsis from clinical data. Design: Participants submitted containerized algorithms to a cloud-based testing environment, where we graded entries for their binary classification performance using a novel clinical utility-based evaluation metric. We designed this scoring function specifically for the Challenge to reward algorithms for early predictions and penalize them for late or missed predictions and for false alarms. Setting: ICUs in three separate hospital systems. We shared data from two systems publicly and sequestered data from all three systems for scoring. Patients: We sourced over 60,000 ICU patients with up to 40 clinical variables for each hour of a patient’s ICU stay. We applied Sepsis-3 clinical criteria for sepsis onset. Interventions: None. Measurements and Main Results: A total of 104 groups from academia and industry participated, contributing 853 submissions. Furthermore, 90 abstracts based on Challenge entries were accepted for presentation at Computing in Cardiology. Conclusions: Diverse computational approaches predict the onset of sepsis several hours before clinical recognition, but generalizability to different hospital systems remains a challenge.
    Type of Medium: Online Resource
    ISSN: 0090-3493
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 197890-1
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  • 4
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 17, No. 6 ( 2024-06)
    Abstract: ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coronary disease; however, there were conservative strategy participants who underwent invasive coronary angiography early postrandomization (within 6 months). Identifying factors associated with angiography in conservative strategy participants will inform clinical decision-making in patients with chronic coronary disease. METHODS: Factors independently associated with angiography performed within 6 months of randomization were identified using Fine and Gray proportional subdistribution hazard models, including demographics, region of randomization, medical history, risk factor control, symptoms, ischemia severity, coronary anatomy based on protocol-mandated coronary computed tomography angiography, and medication use. RESULTS: Among 2591 conservative strategy participants, angiography within 6 months of randomization occurred in 8.7% (4.7% for a suspected primary end point event, 1.6% for persistent symptoms, and 2.6% due to protocol nonadherence) and was associated with the following baseline characteristics: enrollment in Europe versus Asia (hazard ratio [HR], 1.81 [95% CI, 1.14–2.86] ), daily and weekly versus no angina (HR, 5.97 [95% CI, 2.78–12.86] and 2.63 [95% CI, 1.51–4.58] , respectively), poor to fair versus good to excellent health status (HR, 2.02 [95% CI, 1.23–3.32]) assessed with Seattle Angina Questionnaire, and new/more frequent angina prerandomization (HR, 1.80 [95% CI, 1.34–2.40] ). Baseline low-density lipoprotein cholesterol 〈 70 mg/dL was associated with a lower risk of angiography (HR, 0.65 [95% CI, 0.46–0.91) but not baseline ischemia severity nor the presence of multivessel or proximal left anterior descending artery stenosis 〉 70% on coronary computed tomography angiography. CONCLUSIONS: Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in 〈 10% of patients. It was associated with frequent or increasing baseline angina and poor quality of life but not with objective markers of disease severity. Well-controlled baseline low-density lipoprotein cholesterol was associated with a reduced likelihood of angiography. These findings point to the importance of a comprehensive assessment of symptoms and a review of guideline-directed medical therapy goals when deciding the initial treatment strategy for chronic coronary disease. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01471522.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
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    detail.hit.zdb_id: 2450797-0
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  • 5
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. 9 ( 2013-09), p. 2381-2387
    Abstract: In a previous study, 0.3 and 0.45 mg/kg of intravenous recombinant tissue plasminogen activator (rt-PA) were safe when combined with eptifibatide 75 mcg/kg bolus and a 2-hour infusion (0.75 mcg/kg per minute). The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke–Enhanced Regimen (CLEAR-ER) trial sought to determine the safety of a higher-dose regimen and to establish evidence for a phase III trial. Methods— CLEAR-ER was a multicenter, double-blind, randomized safety study. Ischemic stroke patients were randomized to 0.6 mg/kg rt-PA plus eptifibatide (135 mcg/kg bolus and a 2-hour infusion at 0.75 mcg/kg per minute) versus standard rt-PA (0.9 mg/kg). The primary safety end point was the incidence of symptomatic intracranial hemorrhage within 36 hours. The primary efficacy outcome measure was the modified Rankin Scale (mRS) score ≤1 or return to baseline mRS at 90 days. Analysis of the safety and efficacy outcomes was done with multiple logistic regression. Results— Of 126 subjects, 101 received combination therapy, and 25 received standard rt-PA. Two (2%) patients in the combination group and 3 (12%) in the standard group had symptomatic intracranial hemorrhage (odds ratio, 0.15; 95% confidence interval, 0.01–1.40; P =0.053). At 90 days, 49.5% of the combination group had mRS ≤1 or return to baseline mRS versus 36.0% in the standard group (odds ratio, 1.74; 95% confidence interval, 0.70–4.31; P =0.23). After adjusting for age, baseline National Institutes of Health Stroke Scale, time to intravenous rt-PA, and baseline mRS, the odds ratio was 1.38 (95% confidence interval, 0.51–3.76; P =0.52). Conclusions— The combined regimen of intravenous rt-PA and eptifibatide studied in this trial was safe and provides evidence that a phase III trial is warranted to determine efficacy of the regimen. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00894803.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
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