To examine the risk of cardiovascular outcomes and diabetes mellitus in patients prescribed second-generation antipsychotics.
From the MarketScan claims database, nondiabetic adults prescribed ...aripiprazole between July 2003 and March 2010 were propensity score-matched with patients prescribed olanzapine, quetiapine, risperidone, and ziprasidone. Patients were followed through the claims for International Classification of Diseases, Ninth Revision codes indicating myocardial infarction, stroke, heart failure, coronary bypass/angioplasty procedures, and incident diabetes. Incidence rates of each outcome were calculated and compared between aripiprazole and the other second-generation antipsychotics using Cox models.
Aripiprazole initiators were matched 1:1 to 9,917 olanzapine, 14,935 quetiapine, 10,192 risperidone, and 5,696 ziprasidone initiators. Increased risk was found with olanzapine for stroke (hazard ratio = 1.43; 95% confidence interval, 1.05-1.95) and any cardiovascular event (1.28; 1.05-1.55); with quetiapine for stroke (1.58; 1.19-2.09), heart failure (1.55; 1.15-2.11), and any cardiovascular event (1.50; 1.25-1.79); and with risperidone for stroke (1.54; 1.12-2.12), heart failure (1.43; 1.02-1.99), and any cardiovascular event (1.49; 1.21-1.83). Ziprasidone showed no significant difference in risk from aripiprazole for any outcome. Incidence of diabetes ranged from 18 to 21 events per 1,000 person-years in each cohort and did not differ significantly between second-generation drugs.
This analysis of real-world data found lower risk of some cardiovascular events with aripiprazole than with olanzapine, quetiapine, or risperidone, but no differences were found with ziprasidone. There were no significant differences in risk of diabetes. Limitations include use of claims data and inability to adequately control for differential prescribing of second-generation antipsychotics to patients at higher risk of diabetes.
The essays in Copernirus and his Successors deal both with the influences on Copernicus, including that of Greek and Arabic thinkers, and with his own life and attitudes. They also examine how he was ...seen by contemporaries and finally describe his relationship to other scientists, including Galileo, Brahe and Kepler.
We described care received by hospitalized children with COVID-19 or multi-system inflammatory syndrome (MIS-C) prior to the 2021 COVID-19 Omicron variant surge in the US. We identified hospitalized ...children <18 years of age with a COVID-19 or MIS-C diagnosis (COVID-19 not required), separately, from February 2020-September 2021 (n = 126 hospitals). We described high-risk conditions, inpatient treatments, and complications among these groups. Among 383,083 pediatric hospitalizations, 2,186 had COVID-19 and 395 had MIS-C diagnosis. Less than 1% had both COVID-19 and MIS-C diagnosis (n = 154). Over half were >6 years old (54% COVID-19, 70% MIS-C). High-risk conditions included asthma (14% COVID-19, 11% MIS-C), and obesity (9% COVID-19, 10% MIS-C). Pulmonary complications in children with COVID-19 included viral pneumonia (24%) and acute respiratory failure (11%). In reference to children with COVID-19, those with MIS-C had more hematological disorders (62% vs 34%), sepsis (16% vs 6%), pericarditis (13% vs 2%), myocarditis (8% vs 1%). Few were ventilated or died, but some required oxygen support (38% COVID-19, 45% MIS-C) or intensive care (42% COVID-19, 69% MIS-C). Treatments included: methylprednisolone (34% COVID-19, 75% MIS-C), dexamethasone (25% COVID-19, 15% MIS-C), remdesivir (13% COVID-19, 5% MIS-C). Antibiotics (50% COVID-19, 68% MIS-C) and low-molecular weight heparin (17% COVID-19, 34% MIS-C) were frequently administered. Markers of illness severity among hospitalized children with COVID-19 prior to the 2021 Omicron surge are consistent with previous studies. We report important trends on treatments in hospitalized children with COVID-19 to improve the understanding of real-world treatment patterns in this population.
Introduction
During the COVID‐19 pandemic, inpatient electronic health records (EHRs) have been used to conduct public health surveillance and assess treatments and outcomes. Invasive mechanical ...ventilation (MV) and supplemental oxygen (O2) use are markers of severe illness in hospitalized COVID‐19 patients. In a large US system (n = 142 hospitals), we assessed documentation of MV and O2 use during COVID‐19 hospitalization in administrative data versus nursing documentation.
Methods
We identified 319 553 adult hospitalizations with a COVID‐19 diagnosis, February 2020–October 2022, and extracted coded, administrative data for MV or O2. Separately, we developed classification rules for MV or O2 supplementation from semi‐structured nursing documentation. We assessed MV and O2 supplementation in administrative data versus nursing documentation and calculated ordinal endpoints of decreasing COVID‐19 disease severity. Nursing documentation was considered the gold standard in sensitivity and positive predictive value (PPV) analyses.
Results
In nursing documentation, the prevalence of MV and O2 supplementation among COVID‐19 hospitalizations was 14% and 75%, respectively. The sensitivity of administrative data was 83% for MV and 41% for O2, with both PPVs above 91%. Concordance between sources was 97% for MV (κ = 0.85), and 54% for O2 (κ = 0.21). For ordinal endpoints, administrative data accurately identified intensive care and MV but underestimated hospitalizations with O2 requirements (42% vs. 18%).
Conclusions
In comparison to nursing documentation, administrative data under‐ascertained O2 supplementation but accurately estimated severe endpoints such as MV. Nursing documentation improved ascertainment of O2 among COVID‐19 hospitalizations and can capture oxygen requirements in adults hospitalized with COVID‐19 or other respiratory illnesses.
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical ...product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID‐19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID‐19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data.
Early in the pandemic, Sentinel developed a multi‐pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID‐19, validated a diagnosis‐code based algorithm for identifying patients with COVID‐19 in administrative claims data, and coordinated with other national and international initiatives.
Sentinel is poised to answer important questions about the natural history of COVID‐19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID‐19 prevention and treatment.
The essays in Copernirus and his Successors deal both with the influences on Copernicus, including that of Greek and Arabic thinkers, and with his own life and attitudes. They also examine how he was ...seen by contemporaries and finally describe his relationship to other scientists, including Galileo, Brahe and Kepler.
Background
We assessed the ability to identify key data relevant to influenza and other respiratory virus surveillance in a large‐scale US‐based hospital electronic medical record (EMR) dataset using ...seasonal influenza as a use case. We describe characteristics and outcomes of hospitalized influenza cases across three seasons.
Methods
We identified patients with an influenza diagnosis between March 2017 and March 2020 in 140 US hospitals as part of the US FDA's Sentinel System. We calculated descriptive statistics on the presence of high‐risk conditions, influenza antiviral administrations, and severity endpoints.
Results
Among 5.1 million hospitalizations, we identified 29,520 hospitalizations with an influenza diagnosis; 64% were treated with an influenza antiviral within 2 days of admission, and 25% were treated >2 days after admission. Patients treated >2 days after admission had more comorbidities than patients treated within 2 days of admission. Patients never treated during hospitalization had more documentation of cardiovascular and other diseases than treated patients. We observed more severe endpoints in patients never treated (death = 3%, mechanical ventilation MV = 9%, intensive care unit ICU = 26%) or patients treated >2 days after admission (death = 2%, MV = 14%, ICU = 32%) than in patients treated earlier (treated on admission: death = 1%, MV = 5%, ICU = 23%, treated within 2 days of admission: death = 1%, MV = 7%, ICU = 27%).
Conclusions
We identified important trends in influenza severity related to treatment timing in a large inpatient dataset, laying the groundwork for the use of this and other inpatient EMR data for influenza and other respiratory virus surveillance.
Abstract
Background
Up to 40% of hospitalized patients receive unnecessary or inappropriately broad antibiotics despite a low risk of multidrug-resistant organism (MDRO) infection. Empiric standard ...spectrum antibiotic use would reduce extended-spectrum (ES) antibiotic exposure and future resistance. We evaluated whether computerized prescriber order entry prompts providing patient-specific MDRO risk estimates could reduce ES antibiotic use compared to routine stewardship practices in patients hospitalized with pneumonia.
Methods
This 59 hospital cluster-randomized trial compared: 1) INSPIRE prompts providing patient-specific MDRO pneumonia risk estimates at order entry and recommended standard spectrum antibiotics for risk < 10% versus 2) routine stewardship practices. Prompt used an absolute MDRO risk algorithm based on a 140 hospital data set. Trial population included adults treated with antibiotics for pneumonia in ED or non-ICU wards in first 3 days of admission (empiric days); prompt was triggered if ES antibiotics were ordered. Prescribers received feedback on prompt response. Trial periods: 18-month Baseline (Apr 2017–Sept 2018); 6-month Phase-in (Oct 2018–Mar 2019); 15-month Intervention (Apr 2019 – June 2020). Primary outcome was ES antibiotic days of therapy (ES-DOT) per empiric day; secondary outcomes were a) vancomycin and b) anti-pseudomonal DOT per empiric day. Unadjusted, as-randomized analyses used generalized linear mixed effects models to assess differences in ES-DOT rates between the intervention vs baseline period across arms (difference in differences), while clustering by patient and hospital.
Results
We randomized 59 hospitals in 12 states, with 59,897 and 51,486 non-ICU pneumonia admissions in baseline and intervention periods, respectively. Intervention group had a 33% reduction in ES-DOT compared to routine care. Vancomycin and anti-pseudomonal DOT were similarly reduced in the intervention group by 27% and 33%, respectively (Table).
Conclusion
INSPIRE order entry prompts providing real-time, patient-specific MDRO risk estimates with recommendation to use standard spectrum antibiotics in low risk patients significantly reduced empiric ES prescribing in adults admitted with pneumonia.
Disclosures
Shruti K. Gohil, MD, MPH, Medline (Other Financial or Material Support, Co-Investigator in studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Molnycke (Other Financial or Material Support, Co-Investigator in studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Stryker (Sage) (Other Financial or Material Support, Co-Investigator in studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products) Edward Septimus, MD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products) Ken Kleinman, PhD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products) Lauren Heim, MPH, Medline (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Stryker (Sage) (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product)Xttrium (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product) Syma Rashid, MD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Stryker (Sage) (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product)Xttrium (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product) Taliser R. Avery, MS, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Kenneth Sands, MD, MPH, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Julia Moody, MS, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Micaela H. Coady, MS, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Kimberly N. Smith, MBA, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Brandon Carver, BA, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Caren Spencer-Smith, MS, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Russell Poland, PhD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Jason Hickok, MBA, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Arjun Srinivasan, MD, Nothing to disclose John A. Jernigan, MD, MS, Nothing to disclose Jonathan B. Perlin, MD, PhD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Richard Platt, MD, MSc, Medline (Research Grant or Support, Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Susan S. Huang, MD, MPH, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Stryker (Sage) (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Xttrium (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)
Abstract
Background
Up to 40% of hospitalized patients receive unnecessary or inappropriately broad antibiotics despite a low risk of multidrug-resistant organism (MDRO) infection. Empiric standard ...spectrum antibiotic use would reduce extended-spectrum (ES) antibiotic exposure and future resistance. We evaluated whether computerized prescriber order entry prompts providing patient-specific MDRO risk estimates could reduce ES antibiotic use compared to routine stewardship practices in patients hospitalized with urinary tract infection (UTI).
Methods
This 59-hospital cluster randomized trial compared: 1) INSPIRE prompts providing patient-specific MDRO UTI risk estimates at order entry and recommended standard spectrum antibiotics for risk < 10% versus 2) routine stewardship practices. Prompt used an absolute MDRO risk algorithm based on a 140 hospital data set. Trial population included adults treated with antibiotics for UTI in ED or non-ICU wards in first 3 days of admission (empiric days); prompt was triggered if ES antibiotics were ordered. Prescribers received feedback on prompt response. Trial periods: 18-month Baseline (Apr 2017–Sept 2018); 6-month Phase-in (Oct 2018–Mar 2019); 15-month Intervention (Apr 2019 – June 2020). Primary outcome was ES antibiotic days of therapy (ES-DOT) per empiric day; secondary outcomes were a) vancomycin and b) anti-pseudomonal DOT per empiric day. Unadjusted, as-randomized analyses used generalized linear mixed effects models to assess differences in ES-DOT rates between the intervention vs baseline period across arms (difference in differences), while clustering by patient and hospital.
Results
Results: We randomized 59 hospitals in 12 states, with 87,749 and 66,996 non-ICU UTI admissions in baseline and intervention periods, respectively. Intervention group had a a 21% reduction in ES-DOT compared to routine care. Vancomycin and anti-pseudomonal DOT were similarly reduced in the intervention group by 17% and 23%, respectively (Table).
Conclusion
Conclusion: INSPIRE order entry prompts providing real-time, patient-specific MDRO risk estimates with recommendation to use standard spectrum antibiotics in low risk patients significantly reduced empiric ES prescribing in adults admitted with UTI.
Disclosures
Shruti K. Gohil, MD, MPH, Medline (Other Financial or Material Support, Co-Investigator in studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Molnycke (Other Financial or Material Support, Co-Investigator in studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Stryker (Sage) (Other Financial or Material Support, Co-Investigator in studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products) Edward Septimus, MD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products) Ken Kleinman, PhD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic products) Lauren Heim, MPH, Medline (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Stryker (Sage) (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product)Xttrium (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product) Syma Rashid, MD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Stryker (Sage) (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product)Xttrium (Other Financial or Material Support, Conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic product) Taliser R. Avery, MS, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Kenneth Sands, MD, MPH, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Julia Moody, MS, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Kimberly N. Smith, MBA, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Brandon Carver, BA, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Caren Spencer-Smith, MS, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Russell Poland, PhD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Jason Hickok, MBA, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Arjun Srinivasan, MD, Nothing to disclose John A. Jernigan, MD, MS, Nothing to disclose Jonathan B. Perlin, MD, PhD, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Richard Platt, MD, MSc, Medline (Research Grant or Support, Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals received contributed antiseptic product) Susan S. Huang, MD, MPH, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Stryker (Sage) (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Xttrium (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)
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