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  1. Article ; Online: COVID-19-Associated Acute Kidney Injury and Longitudinal Kidney Outcomes.

    Aklilu, Abinet M / Kumar, Sanchit / Nugent, James / Yamamoto, Yu / Coronel-Moreno, Claudia / Kadhim, Bashar / Faulkner, Sophia C / O'Connor, Kyle D / Yasmin, Farah / Greenberg, Jason H / Moledina, Dennis G / Testani, Jeffrey M / Wilson, F Perry

    JAMA internal medicine

    2024  Volume 184, Issue 4, Page(s) 414–423

    Abstract: Importance: COVID-19 infection is associated with a high incidence of acute kidney injury (AKI). Although rapid kidney function decline has been reported in the first few months after COVID-19-associated AKI (COVID-AKI), the longer-term association of ... ...

    Abstract Importance: COVID-19 infection is associated with a high incidence of acute kidney injury (AKI). Although rapid kidney function decline has been reported in the first few months after COVID-19-associated AKI (COVID-AKI), the longer-term association of COVID-AKI with kidney function remains unknown.
    Objective: To assess long-term kidney outcomes of patients who had COVID-19-associated AKI.
    Design, setting, and participants: This was a retrospective longitudinal multicenter cohort study conducted in a large hospital system using electronic health records data on adult hospitalized patients with AKI and COVID-19 or other illnesses. Included patients were hospitalized during the COVID-19 pandemic (March 2020-June 2022), were screened for SARS-CoV-2, had AKI, and survived to discharge, or had been hospitalized during the 5 years before the pandemic (October 2016-January 2020), had a positive influenza A or B test result, had AKI, and survived to discharge. Patients were followed up for a maximum of 2 years after hospital discharge. Data analyses were performed from December 2022 to November 2023.
    Exposure: COVID-19 and influenza.
    Main outcomes and measures: The primary outcome was major adverse kidney events (MAKE), defined as a composite of mortality and worsened kidney function (estimated glomerular filtration rate [eGFR] decline by ≥25% from discharge eGFR or kidney failure requiring dialysis). Multivariable time-to-event analyses were performed to compare MAKE between individuals with COVID-AKI and those who had AKI associated with other illnesses hospitalized during the same period. For further comparison, this outcome was assessed for a historic cohort of patients with influenza-associated AKI.
    Results: The study cohort included 9624 hospitalized patients (mean [SD] age, 69.0 [15.7] years; 4955 [51.5%] females) with AKI, including 987 patients with COVID-AKI, 276 with influenza-associated AKI, and 8361 with AKI associated with other illnesses (other-AKI). Compared with the other 2 groups, patients with COVID-19-associated AKI were slightly younger in age, had a higher baseline eGFR, worse baseline comorbidity scores, higher markers of illness severity, and longer hospital stay. Compared with the other-AKI group, the COVID-AKI group had lower MAKE (adjusted hazard ratio [aHR], 0.67; 95% CI, 0.59-0.75) due to lower all-cause mortality (aHR, 0.31; 95% CI, 0.24-0.39) and lower rates of worsened kidney function (aHR, 0.78; 95% CI, 0.69-0.88).
    Conclusions and relevance: The findings of this multicenter cohort study indicate that survivors of hospitalization with COVID-AKI experience lower rates of MAKE, long-term kidney function decline, and mortality compared with patients with AKI associated with other illnesses.
    MeSH term(s) Adult ; Female ; Humans ; Aged ; Male ; Cohort Studies ; Retrospective Studies ; Pandemics ; Influenza, Human ; COVID-19/complications ; COVID-19/epidemiology ; SARS-CoV-2 ; Kidney ; Acute Kidney Injury/epidemiology ; Acute Kidney Injury/etiology ; Risk Factors
    Language English
    Publishing date 2024-02-26
    Publishing country United States
    Document type Multicenter Study ; Journal Article
    ZDB-ID 2699338-7
    ISSN 2168-6114 ; 2168-6106
    ISSN (online) 2168-6114
    ISSN 2168-6106
    DOI 10.1001/jamainternmed.2023.8225
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  2. Article ; Online: Rationale, Design, and Patient Characteristics of a Cluster-Randomized Pragmatic Trial to Improve Mineralocorticoid Antagonist Use.

    Clark, Katherine A A / Victoria-Castro, Angela M / Ghazi, Lama / Yamamoto, Yu / Coronel-Moreno, Claudia / Kadhim, Bashar Adel / Riello, Ralph J / O'Connor, Kyle / Ahmad, Tariq / Wilson, F Perry / Desai, Nihar R

    JACC. Heart failure

    2023  Volume 12, Issue 2, Page(s) 322–332

    Abstract: Background: Despite robust evidence and strong guideline recommendations supporting use of mineralocorticoid receptor antagonists (MRAs) to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF), these medications remain ... ...

    Abstract Background: Despite robust evidence and strong guideline recommendations supporting use of mineralocorticoid receptor antagonists (MRAs) to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF), these medications remain underused in clinical practice.
    Objectives: The goal is to determine if providing a tailored best practice alert (BPA) to outpatient providers suggesting guideline-recommended MRAs or information about available hyperkalemia treatment, if present, for patients with HFrEF will increase short-term MRA prescriptions.
    Methods: PROMPT-MRA (Pragmatic Trial of Messaging to Providers About Treatment With Mineralocorticoid Receptor Antagonists) is a pragmatic, cluster-randomized, controlled study. A total of 119 providers were randomized to receive a BPA or usual care. During an outpatient visit with participating providers, the BPA displayed recent laboratory test values and ejection fraction. The alert suggested guideline-recommended MRAs for eligible patients with a serum potassium of <5.0 mEq/L or novel potassium binders for those with a serum potassium of ≥5.0 mEq/L, each linked to an order set containing the corresponding medication and laboratory monitoring.
    Results: PROMPT-MRA completed enrollment with 1,210 patients. The primary outcome of PROMPT-MRA is to determine if a tailored BPA for outpatients with HFrEF will lead to higher MRA prescriptions 6 months following randomization compared with usual care. Secondary outcomes included incidence of hyperkalemia, use of novel potassium binders, heart failure hospitalizations, and mortality.
    Conclusions: If effective, the BPA can be scaled to improve population health outcomes with increased MRA prescribing among eligible patients with HFrEF, with or without a history of hyperkalemia. (Pragmatic Trial of Alerts for Use of Mineralocorticoid Receptor Antagonists [PROMPT-MRA]; NCT04903717).
    MeSH term(s) Humans ; Heart Failure/drug therapy ; Hyperkalemia/epidemiology ; Mineralocorticoid Receptor Antagonists/therapeutic use ; Potassium/blood ; Stroke Volume
    Chemical Substances Mineralocorticoid Receptor Antagonists ; Potassium (RWP5GA015D)
    Language English
    Publishing date 2023-11-08
    Publishing country United States
    Document type Journal Article ; Pragmatic Clinical Trial ; Randomized Controlled Trial
    ZDB-ID 2705621-1
    ISSN 2213-1787 ; 2213-1779
    ISSN (online) 2213-1787
    ISSN 2213-1779
    DOI 10.1016/j.jchf.2023.08.025
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  3. Article ; Online: A randomized clinical trial assessing the effect of automated medication-targeted alerts on acute kidney injury outcomes.

    Wilson, F Perry / Yamamoto, Yu / Martin, Melissa / Coronel-Moreno, Claudia / Li, Fan / Cheng, Chao / Aklilu, Abinet / Ghazi, Lama / Greenberg, Jason H / Latham, Stephen / Melchinger, Hannah / Mansour, Sherry G / Moledina, Dennis G / Parikh, Chirag R / Partridge, Caitlin / Testani, Jeffrey M / Ugwuowo, Ugochukwu

    Nature communications

    2023  Volume 14, Issue 1, Page(s) 2826

    Abstract: Acute kidney injury is common among hospitalized individuals, particularly those exposed to certain medications, and is associated with substantial morbidity and mortality. In a pragmatic, open-label, National Institutes of Health-funded, parallel group ... ...

    Abstract Acute kidney injury is common among hospitalized individuals, particularly those exposed to certain medications, and is associated with substantial morbidity and mortality. In a pragmatic, open-label, National Institutes of Health-funded, parallel group randomized controlled trial (clinicaltrials.gov NCT02771977), we investigate whether an automated clinical decision support system affects discontinuation rates of potentially nephrotoxic medications and improves outcomes in patients with AKI. Participants included 5060 hospitalized adults with AKI and an active order for any of three classes of medications of interest: non-steroidal anti-inflammatory drugs, renin-angiotensin-aldosterone system inhibitors, or proton pump inhibitors. Within 24 hours of randomization, a medication of interest was discontinued in 61.1% of the alert group versus 55.9% of the usual care group (relative risk 1.08, 1.04 - 1.14, p = 0.0003). The primary outcome - a composite of progression of acute kidney injury, dialysis, or death within 14 days - occurred in 585 (23.1%) of individuals in the alert group and 639 (25.3%) of patients in the usual care group (RR 0.92, 0.83 - 1.01, p = 0.09). Trial Registration Clinicaltrials.gov NCT02771977.
    MeSH term(s) United States ; Adult ; Humans ; Renal Dialysis ; Acute Kidney Injury ; Renin-Angiotensin System
    Language English
    Publishing date 2023-05-17
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2553671-0
    ISSN 2041-1723 ; 2041-1723
    ISSN (online) 2041-1723
    ISSN 2041-1723
    DOI 10.1038/s41467-023-38532-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial.

    Ghazi, Lama / Yamamoto, Yu / Riello, Ralph J / Coronel-Moreno, Claudia / Martin, Melissa / O'Connor, Kyle D / Simonov, Michael / Huang, Joanna / Olufade, Temitope / McDermott, James / Dhar, Ravi / Inzucchi, Silvio E / Velazquez, Eric J / Wilson, F Perry / Desai, Nihar R / Ahmad, Tariq

    Journal of the American College of Cardiology

    2022  Volume 79, Issue 22, Page(s) 2203–2213

    Abstract: Background: The use of guideline-directed medical therapy (GDMT) is underprescribed in patients with heart failure with reduced ejection fraction (HFrEF).: Objectives: This study sought to examine whether targeted and tailored electronic health ... ...

    Abstract Background: The use of guideline-directed medical therapy (GDMT) is underprescribed in patients with heart failure with reduced ejection fraction (HFrEF).
    Objectives: This study sought to examine whether targeted and tailored electronic health record (EHR) alerts recommending GDMT in eligible patients with HFrEF improves GDMT use.
    Methods: PROMPT-HF (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure) was a pragmatic, EHR-based, cluster-randomized comparative effectiveness trial. A total of 100 providers caring for patients with HFrEF were randomized to either an alert or usual care. The alert notified providers of individualized GDMT recommendations along with patient characteristics. The primary outcome was an increase in the number of GDMT classes prescribed at 30 days postrandomization. Providers were surveyed on knowledge of guidelines and user experience.
    Results: The study enrolled 1,310 ambulatory patients with HFrEF from April to October 2021. Median age was 72 years; 31% were female; 18% were Black; and median left ventricular ejection fraction was 32%. At baseline, 84% of participants were receiving β-blockers, 71% received a renin-angiotensin-aldosterone system inhibitor, 29% received a mineralocorticoid receptor antagonist, and 11% received a sodium-glucose cotransporter-2 inhibitor. The primary outcome occurred in 176 of 685 (26%) participants in the alert arm vs 117 of 625 (19%) in the usual care arm, thus increasing GDMT class prescription by >40% after alert exposure (adjusted relative risk: 1.41; 95% CI: 1.03-1.93; P = 0.03). The number of patients needed to alert to result in an increase in addition of GDMT classes was 14. A total of 79% of alerted providers agreed that the alert was effective at enabling improved prescription of medical therapy for HF.
    Conclusions: A real-time, targeted, and tailored EHR-based alerting system for outpatients with HFrEF led to significantly higher rates of GDMT at 30 days when compared with usual care. This low-cost intervention can be rapidly integrated into clinical care and accelerate adoption of high-value therapies in heart failure. (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure [PROMPT-HF; NCT04514458]).
    MeSH term(s) Aged ; Anti-Arrhythmia Agents/therapeutic use ; Cardiotonic Agents/therapeutic use ; Diabetes Mellitus, Type 2 ; Electronics ; Female ; Heart Failure/drug therapy ; Humans ; Male ; Outpatients ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use ; Stroke Volume ; Ventricular Dysfunction, Left ; Ventricular Function, Left
    Chemical Substances Anti-Arrhythmia Agents ; Cardiotonic Agents ; Sodium-Glucose Transporter 2 Inhibitors
    Language English
    Publishing date 2022-04-03
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 605507-2
    ISSN 1558-3597 ; 0735-1097
    ISSN (online) 1558-3597
    ISSN 0735-1097
    DOI 10.1016/j.jacc.2022.03.338
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  5. Article ; Online: Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial.

    Aklilu, Abinet Mathias / O'Connor, Kyle D / Martin, Melissa / Yamamoto, Yu / Coronel-Moreno, Claudia / Shvets, Kristina / Jones, Charles / Kadhim, Bashar / Corona-Villalobos, Celia P / Baker, Megan L / Tan, Jiawei / Freeman, Natasha / Groener, Marwin / Menez, Steven / Brown, Dannielle / Culli, Samuel E / Lindsley, John / Orias, Marcelo / Parikh, Chirag /
    Smith, Abigail / Sundararajan, Anusha / Wilson, Francis P

    BMJ open

    2023  Volume 13, Issue 4, Page(s) e071968

    Abstract: Introduction: Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the ... ...

    Abstract Introduction: Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients.
    Methods and analysis: KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid-base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8-51.5) min.
    Ethics and dissemination: The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion.
    Trial registration number: NCT04040296.
    MeSH term(s) Humans ; COVID-19 ; SARS-CoV-2 ; Renal Dialysis ; Acute Kidney Injury/diagnosis ; Acute Kidney Injury/therapy ; Kidney ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
    Language English
    Publishing date 2023-04-17
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2023-071968
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  6. Article: The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines

    Baker, Meghan A / Jankosky, Christopher / Yih, W. Katherine / Gruber, Susan / Li, Lingling / Cocoros, Noelle M / Lipowicz, Hana / Coronel-Moreno, Claudia / DeLuccia, Sandra / Lin, Nancy D / McMahill-Walraven, Cheryl N / Menschik, David / Selvan, Mano S / Selvam, Nandini / Chen Tilney, Rong / Zichittella, Lauren / Lee, Grace M / Kawai, Alison Tse

    Elsevier Ltd Vaccine. 2020 Feb. 24, v. 38, no. 9

    2020  

    Abstract: Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in ... ...

    Abstract Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6–23 months of age during the 2013–14 and 2014–15 influenza seasons.Using claims data and a self-controlled risk interval design, we compared the febrile seizure rate in a risk interval (0–1 days) versus control interval (14–20 days). In exploratory analyses, we assessed whether the effect of IIV was modified by concomitant PCV13 administration.Adjusted for age, calendar time and concomitant administration of the other vaccine, the incidence rate ratio (IRR) for risk of febrile seizures following IIV was 1.12 (95% CI 0.80, 1.56) and following PCV13 was 1.80 (95% CI 1.29, 2.52). The attributable risk for febrile seizures following PCV13 ranged from 0.33 to 5.16 per 100,000 doses by week of age.The age and calendar-time adjusted IRR comparing exposed to unexposed time was numerically larger for concomitant IIV and PCV13 (IRR 2.80, 95% CI 1.63, 4.83), as compared to PCV13 without concomitant IIV (IRR 1.54, 95% CI 1.04, 2.28), and the IRR for IIV without concomitant PCV13 suggested no independent effects of IIV (IRR 0.94, 95% CI 0.63, 1.42). Taken together, this suggests a possible interaction between IIV and PCV13, though our study was not sufficiently powered to provide a precise estimate of the interaction.We found an elevated risk of febrile seizures after PCV13 vaccine but not after IIV. The risk of febrile seizures after PCV13 is low compared to the overall risk in this population of children, and the risk should be interpreted in the context of the importance of preventing pneumococcal infections.
    Keywords Streptococcus pneumoniae ; children ; influenza ; influenza vaccines ; risk ; seizures
    Language English
    Dates of publication 2020-0224
    Size p. 2166-2171.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2020.01.046
    Database NAL-Catalogue (AGRICOLA)

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  7. Article ; Online: The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines.

    Baker, Meghan A / Jankosky, Christopher / Yih, W Katherine / Gruber, Susan / Li, Lingling / Cocoros, Noelle M / Lipowicz, Hana / Coronel-Moreno, Claudia / DeLuccia, Sandra / Lin, Nancy D / McMahill-Walraven, Cheryl N / Menschik, David / Selvan, Mano S / Selvam, Nandini / Chen Tilney, Rong / Zichittella, Lauren / Lee, Grace M / Kawai, Alison Tse

    Vaccine

    2020  Volume 38, Issue 9, Page(s) 2166–2171

    Abstract: Background: Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and ... ...

    Abstract Background: Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6-23 months of age during the 2013-14 and 2014-15 influenza seasons.
    Methods: Using claims data and a self-controlled risk interval design, we compared the febrile seizure rate in a risk interval (0-1 days) versus control interval (14-20 days). In exploratory analyses, we assessed whether the effect of IIV was modified by concomitant PCV13 administration.
    Results: Adjusted for age, calendar time and concomitant administration of the other vaccine, the incidence rate ratio (IRR) for risk of febrile seizures following IIV was 1.12 (95% CI 0.80, 1.56) and following PCV13 was 1.80 (95% CI 1.29, 2.52). The attributable risk for febrile seizures following PCV13 ranged from 0.33 to 5.16 per 100,000 doses by week of age. The age and calendar-time adjusted IRR comparing exposed to unexposed time was numerically larger for concomitant IIV and PCV13 (IRR 2.80, 95% CI 1.63, 4.83), as compared to PCV13 without concomitant IIV (IRR 1.54, 95% CI 1.04, 2.28), and the IRR for IIV without concomitant PCV13 suggested no independent effects of IIV (IRR 0.94, 95% CI 0.63, 1.42). Taken together, this suggests a possible interaction between IIV and PCV13, though our study was not sufficiently powered to provide a precise estimate of the interaction.
    Conclusions: We found an elevated risk of febrile seizures after PCV13 vaccine but not after IIV. The risk of febrile seizures after PCV13 is low compared to the overall risk in this population of children, and the risk should be interpreted in the context of the importance of preventing pneumococcal infections.
    MeSH term(s) Humans ; Infant ; Influenza Vaccines/adverse effects ; Pneumococcal Vaccines/adverse effects ; Seizures, Febrile/chemically induced ; Seizures, Febrile/epidemiology ; Sentinel Surveillance ; United States ; Vaccines, Conjugate/adverse effects
    Chemical Substances 13-valent pneumococcal vaccine ; Influenza Vaccines ; Pneumococcal Vaccines ; Vaccines, Conjugate
    Language English
    Publishing date 2020-02-01
    Publishing country Netherlands
    Document type Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2020.01.046
    Database MEDical Literature Analysis and Retrieval System OnLINE

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