Publications by authors named "Michael E Matheny"

Rationale And Objective: Acute kidney injury (AKI) is a common complication among hospitalized adults, but AKI prediction and prevention among adults has proved challenging. We used machine learning to update the nephrotoxic injury negated by just-in time action (NINJA), a pediatric program that predicts nephrotoxic AKI, to improve accuracy among adults.

Study Design: A retrospective cohort study.

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Objectives: Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning curves, and time-varying covariates, such as physician experience. To address these limitations, we sought to develop a machine learning (ML) framework to detect and adjust for operator learning effects.

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Article Synopsis
  • - The FDA's Sentinel Innovation Center created a quality-checked network using electronic health records (EHRs) and insurance claims data from over 10 million individuals to enhance regulatory decision-making with real-world data.
  • - The resulting network, called the Real-World Evidence Data Enterprise (RWE-DE), includes data from two commercial sources covering 21 million lives and four academic partners covering 4.5 million lives.
  • - The report details data completeness, patient populations, and a process for managing free-text notes, while also highlighting potential use cases for RWE-DE to address broader questions in healthcare regulation.
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  • Post-marketing safety surveillance can be improved by detecting clinical events through spontaneous reporting, but it requires healthcare professionals to be well-informed and aware of the reporting process.
  • The study introduces a new method for identifying incidents using unstructured clinical data and natural language processing, validated against traditional methods for two specific health concerns: suicide attempts and sleep-related behaviors.
  • Results showed that while the new approach effectively identified suicide attempts with decent precision, it struggled more with sleep-related behaviors; additionally, performance varied by race, highlighting the need for careful monitoring and bias reduction in healthcare AI applications.
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  • Research on peripheral artery disease (PAD) is hindered by the absence of a national registry and insufficient diagnostic coding in electronic health records.
  • A new natural language processing (NLP) system helped establish a registry of over 103,000 new PAD patients within the Veterans Health Administration, revealing high rates of comorbidities and significant clinical outcomes over a year.
  • The study found notable one-year mortality (9.4%) and incidences of cardiovascular (5.6 per 100 patient-years) and limb events (4.5 per 100 patient-years), highlighting the urgent need for better care strategies for this high-risk population.
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  • This study compares the cardiovascular effectiveness of different second-line antihyperglycemic agents (SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, and sulfonylureas) in patients with type 2 diabetes and cardiovascular disease.
  • Using data from over 1.4 million patients across multiple databases, the researchers analyzed the risk of major adverse cardiovascular events (MACE) over a follow-up period of several years.
  • Results indicated that SGLT2 inhibitors and GLP-1 receptor agonists had significantly lower risks of MACE compared to DPP-4 inhibitors and sulfonylureas, pointing to their potential superiority as treatment options for
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Key Points: Treatment discontinuation is common among patients with CKD prescribed sodium-glucose cotransporter-2 (SGLT2) inhibitors (discontinued in 37%) or glucagon-like peptide-1 receptor agonists (GLP-1 RA; discontinued in 47%). Discontinuation of SGLT2 inhibitors and GLP-1 RA was associated with recent hospitalizations, Black race, Hispanic ethnicity, and vascular disease. Discontinuation of both agents was associated with death and cardiovascular events.

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Importance: The Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA advisory committee meetings, and other regulatory decisions. However, observational data are frequently deemed insufficient for reliable evaluation of safety concerns owing to limitations in underlying data or methodology. Advances in large language models (LLMs) provide new opportunities to address some of these limitations.

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  • Acute kidney injury (AKI) is a serious issue in hospitalized patients, prompting a study that analyzed genetic factors in a large cohort from the Million Veteran Program and Vanderbilt University Medical Center.
  • The study included 54,488 patients with AKI and 138,051 without, identifying two significant genetic loci associated with AKI: one near the FTO gene related to obesity and another near SHROOM3 linked to kidney function.
  • The research suggests that genetics may play a role in the risk of developing AKI, with factors like body mass index and diabetes potentially influencing the association with the FTO locus.
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Introduction: Acute kidney injury (AKI) is associated with increased risk of heart failure (HF). Determining the type of HF experienced by AKI survivors (heart failure with preserved or reduced ejection fraction, HFpEF or HFrEF) could suggest potential mechanisms underlying the association and opportunities for improving post-AKI care.

Methods: In this retrospective study of adults within the Vanderbilt University health system with a diagnosis of HF, we tested whether AKI events in the two years preceding incident HF associated more with HFpEF or HFrEF while controlling for known predictors.

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Background: Despite efforts to enhance the quality of medication prescribing in outpatient settings, potentially inappropriate prescribing remains common, particularly in unscheduled settings where patients can present with infectious and pain-related complaints. Two of the most commonly prescribed medication classes in outpatient settings with frequent rates of potentially inappropriate prescribing include antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs). In the setting of persistent inappropriate prescribing, we sought to understand a diverse set of perspectives on the determinants of inappropriate prescribing of antibiotics and NSAIDs in the Veterans Health Administration.

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  • The study aimed to evaluate how often kidney failure occurs in patients receiving intravitreal anti-VEGF treatments and to compare the risks associated with three specific drugs: ranibizumab, aflibercept, and bevacizumab.
  • Researchers conducted a retrospective cohort study, analyzing data from 12 databases within the OHDSI network, focusing on patients over 18 with retinal diseases receiving these treatments.
  • Results showed an average incidence of kidney failure of 678 per 100,000 persons, and no significant differences in risk were found among the three anti-VEGF drugs, indicating similar safety profiles regarding kidney health.
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Objective: Assigning outcome labels to large observational data sets in a timely and accurate manner, particularly when outcomes are rare or not directly ascertainable, remains a significant challenge within biomedical informatics. We examined whether noisy labels generated from subject matter experts' heuristics using heterogenous data types within a data programming paradigm could provide outcomes labels to a large, observational data set. We chose the clinical condition of opioid-induced respiratory depression for our use case because it is rare, has no administrative codes to easily identify the condition, and typically requires at least some unstructured text to ascertain its presence.

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Background: As the enthusiasm for integrating artificial intelligence (AI) into clinical care grows, so has our understanding of the challenges associated with deploying impactful and sustainable clinical AI models. Complex dataset shifts resulting from evolving clinical environments strain the longevity of AI models as predictive accuracy and associated utility deteriorate over time.

Objective: Responsible practice thus necessitates the lifecycle of AI models be extended to include ongoing monitoring and maintenance strategies within health system algorithmovigilance programs.

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  • * The study analyzed data from over 1.4 million patients treated with various second-line diabetes medications, using advanced statistical methods to compare outcomes and risks of heart issues.
  • * Findings indicated that both SGLT2 inhibitors and GLP-1 receptor agonists reduce the risk of cardiovascular events compared to DPP-4 inhibitors and sulfonylureas, but no significant differences were found between SGLT2is and GLP1-RAs themselves regarding heart risks.
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Objective: Assigning outcome labels to large observational data sets in a timely and accurate manner, particularly when outcomes are rare or not directly ascertainable, remains a significant challenge within biomedical informatics. We examined whether noisy labels generated from subject matter experts' heuristics using heterogenous data types within a data programming paradigm could provide outcomes labels to a large, observational data set. We chose the clinical condition of opioid-induced respiratory depression for our use case because it is rare, has no administrative codes to easily identify the condition, and typically requires at least some unstructured text to ascertain its presence.

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Standardized operational definitions are an important tool to improve reproducibility of research using secondary real-world healthcare data. This approach was leveraged for studies evaluating the effectiveness of AZD7442 as COVID-19 pre-exposure prophylaxis across multiple healthcare systems. Value sets were defined, grouped, and mapped.

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Several studies have found associations between air pollution and respiratory disease outcomes. However, there is minimal prognostic research exploring whether integrating air quality into clinical prediction models can improve accuracy and utility. In this study, we built models using both logistic regression and random forests to determine the benefits of including air quality data with meteorological and clinical data in prediction of COPD exacerbations requiring medical care.

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Introduction: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) improve outcomes but are underutilized in patients with chronic kidney disease (CKD). Little is known about reasons for discontinuation and lack of reinitiating these medications. We aimed to explore clinicians' and patients' experiences and perceptions of ACEI/ARB use in CKD.

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Post marketing safety surveillance depends in part on the ability to detect concerning clinical events at scale. Spontaneous reporting might be an effective component of safety surveillance, but it requires awareness and understanding among healthcare professionals to achieve its potential. Reliance on readily available structured data such as diagnostic codes risk under-coding and imprecision.

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Reducing the prevalence of acute kidney injury (AKI) is an important patient safety objective set forth by the National Quality Forum. Despite international guidelines to prevent AKI, there continues to be an inconsistent uptake of these interventions by cardiac teams across practice settings. The IMPROVE-AKI study was designed to test the effectiveness and implementation of AKI preventive strategies delivered through team-based coaching activities.

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Objective: We examined the influence of 4 different risk information formats on inpatient nurses' preferences and decisions with an acute clinical deterioration decision-support system.

Materials And Methods: We conducted a comparative usability evaluation in which participants provided responses to multiple user interface options in a simulated setting. We collected qualitative data using think aloud methods.

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Successfully changing prescribing behavior to reduce inappropriate antibiotic and nonsteroidal anti-inflammatory drug (NSAID) prescriptions often requires combining components into a multicomponent intervention. However, multicomponent interventions often fail because of development and implementation complexity. To increase the likelihood of successfully changing prescribing behavior, we applied a systematic process to design and implement a multicomponent intervention.

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