Publications by authors named "Thomas Falconer"
Background And Aims: Observational healthcare data are an important tool for delineating patients' inflammatory bowel disease (IBD) journey in real-world settings. However, studies that characterize IBD cohorts typically rely on a single resource, apply diverse eligibility criteria, and extract variable sets of attributes, making comparison between cohorts challenging. We aim to longitudinally describe and compare IBD patient cohorts across multiple geographic regions, employing unified data and analysis framework.
View Article and Find Full Text PDFBackground: U.S. FDA's Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative leverages large electronic health records and administrative claims data to conduct active surveillance for CBER-regulated products.
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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
Background: Current hemovigilance methods generally rely on survey data or administrative claims data utilizing billing and revenue codes, each of which has limitations. We used electronic health records (EHR) linked to blood bank data to comprehensively characterize red blood cell (RBC) utilization patterns and trends in three healthcare systems participating in the U.S.
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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.
Markov modeling for cost-effectiveness using federated health data network.
J Am Med Inform Assoc
April 2024
Objective: To introduce 2 R-packages that facilitate conducting health economics research on OMOP-based data networks, aiming to standardize and improve the reproducibility, transparency, and transferability of health economic models.
Materials And Methods: We developed the software tools and demonstrated their utility by replicating a UK-based heart failure data analysis across 5 different international databases from Estonia, Spain, Serbia, and the United States.
Results: We examined treatment trajectories of 47 163 patients.
Background: Predictive models show promise in healthcare, but their successful deployment is challenging due to limited generalizability. Current external validation often focuses on model performance with restricted feature use from the original training data, lacking insights into their suitability at external sites. Our study introduces an innovative methodology for evaluating features during both the development phase and the validation, focusing on creating and validating predictive models for post-surgery patient outcomes with improved generalizability.
View Article and Find Full Text PDFComparative Effectiveness of Second-line Antihyperglycemic Agents for Cardiovascular Outcomes: A Large-scale, Multinational, Federated Analysis of the LEGEND-T2DM Study.
medRxiv
February 2024
Article Synopsis
- * 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.
Article Synopsis
- Postmarket safety surveillance is crucial for mass vaccination programs, but traditional methods face challenges like multiple testing issues and data biases, leading to the need for improved approaches.
- The researchers developed a Bayesian surveillance method that utilizes negative control outcomes to reduce bias and offers increased flexibility in analyzing vaccine-related adverse events.
- Their empirical evaluation, using data from over 360 million patients, showed that this new method significantly outperformed the existing MaxSPRT approach by reducing Type 1 errors and improving estimation accuracy, with all findings made publicly accessible via an R ShinyApp.
Article Synopsis
- The study aimed to evaluate the adoption of second-line antihyperglycaemic medications among type 2 diabetes patients using metformin, analyzing data from 10 US and 7 international health databases.
- A total of 4.8 million participants were included, focusing on the trends in initiating additional diabetes treatments over the years 2011 to 2021.
- Results showed significant growth in the use of cardioprotective drugs (like GLP-1 receptor agonists and SGLT2 inhibitors) as second-line options, with initiation rates varying widely across countries and databases.
Article Synopsis
- Ranitidine, a commonly used medication for stomach issues, was recalled in 2020 due to the discovery of a cancer-causing impurity, raising concerns about its link to cancer among users.
- This study aimed to investigate the cancer risk associated with ranitidine compared to other similar medications known as H2 receptor antagonists.
- Conducted across multiple countries and databases with a large sample size, the research compared cancer incidence in new users of ranitidine against those using alternatives while accounting for various factors to ensure accurate results.
Article Synopsis
- The article investigates how cardiovascular medications affect the survival of patients with liver cirrhosis, a severe liver disease with a high risk of mortality.
- A large retrospective study analyzed data from 32,366 cirrhotic patients diagnosed between 2000 and 2020 at institutions in the U.S. and South Korea, showing mixed results on different medications' impacts on survival.
- Findings reveal that some drugs, like ramipril and losartan, improve survival, while others, such as amiodarone and digoxin, may worsen prognosis, highlighting the need for careful multidisciplinary management of these patients.
Article Synopsis
- Conservative management for prostate cancer (PCa) aims to delay or avoid curative therapy, with the PIONEER initiative using big data to enhance PCa care in Europe.
- The study analyzed over 527,000 diagnosed PCa cases, focusing on 123,146 patients who did not receive treatment within six months of diagnosis to assess long-term outcomes.
- Findings showed common comorbidities like hypertension and diabetes among patients, with notable rates of hospitalization and symptomatic progression, though limitations included insufficient data on treatment intent and patient characteristics.
Background: Alcoholic liver disease (ALD) is still increasing and leads to acute liver injury but also liver cirrhosis and subsequent complications such as liver failure or hepatocellular carcinoma (HCC). As most patients fail to achieve alcohol abstinence, it is essential to identify alternative treatment options in order to improve the outcome of ALD patients.
Methods: Evaluating two large cohorts of patients with ALD from the USA and Korea with a total of 12,006 patients, we investigated the effect on survival of aspirin, metformin, metoprolol, dopamine, and dobutamine drugs in patients with ALD between 2000 and 2020.
Article Synopsis
- The study investigates the potential benefits of alpha-1 blockers, typically used for benign prostatic hyperplasia (BPH), in preventing COVID-19 complications like cytokine storms, but finds insufficient real-world evidence to support this theory.* -
- Researchers utilized large-scale healthcare databases from Spain and the U.S. to analyze over 2 million users of alpha-1 blockers compared to other BPH medications regarding COVID-19 outcomes, employing advanced techniques to ensure accurate results.* -
- The findings indicated no significant difference in COVID-19 diagnosis, hospitalization, or severe hospitalization risks between alpha-1 blocker users and those using alternative treatments, suggesting a need for further research into effective COVID-19 therapies.*
Article Synopsis
- Linear mixed models are useful in healthcare for analyzing data from multiple sites, but sharing sensitive individual patient data is often restricted due to privacy regulations.
- The proposed algorithm allows for fitting distributed linear mixed models (DLMMs) without needing to share individual patient data, achieving the same results as if pooled data were used.
- The study demonstrates this algorithm's effectiveness by analyzing factors related to hospital stays in over 120,000 COVID-19 patients from various global sources while only requiring minimal aggregated data from each site.
Article Synopsis
- The study emphasizes the importance of real world data (RWD) for understanding and responding to the COVID-19 pandemic using a standardized approach through the CHARYBDIS framework.
- Researchers conducted a retrospective database study across multiple countries, including the US and parts of Europe and Asia, involving over 4.5 million individuals and focusing on their clinical characteristics and outcomes.
- Findings reveal higher diagnoses among women but more hospitalizations among men, common comorbidities like diabetes and heart disease, and key symptoms such as cough and fever; this data helps to identify trends in COVID-19 across different populations and time periods.
Article Synopsis
- The study aimed to develop COVID-19 prediction models using influenza data to quickly and accurately assess risks of hospital admission and death in patients diagnosed with COVID-19.
- The researchers created three COVID-19 Estimated Risk (COVER) scores that quantify risks related to pneumonia and mortality based on historical data and validated them using a large dataset of COVID-19 patients across multiple countries.
- They found that seven key health predictors, along with age and sex, effectively distinguished which patients were likely to face severe outcomes, achieving strong performance in model validation.
Article Synopsis
- The study analyzed the demographics, cancer types, comorbidities, and outcomes of patients with a history of cancer who contracted COVID-19, comparing them to those hospitalized with influenza.
- A total of 366,050 diagnosed patients and 119,597 hospitalized patients with COVID-19 were included, with prostate and breast cancers being the most common among the diagnosed cohort, and many patients over 65 years old having multiple health issues.
- The findings revealed a significant occurrence of COVID-19-related deaths among cancer patients, with a range of 2% to 26% depending on hospitalization status, highlighting the need for tailored clinical care for this high-risk group.
Article Synopsis
- - The study aimed to compare the demographics, medical conditions, and outcomes of COVID-19 patients with obesity to those without obesity, based on data from Spain, the UK, and the US from early 2020.
- - A total of over 600,000 diagnosed and over 160,000 hospitalized COVID-19 patients were analyzed, revealing a higher prevalence of obesity among hospitalized patients and noted that women were more frequently represented in the PLWO group.
- - Results indicated that patients living with obesity (PLWO) had more prior medical conditions, experienced more severe COVID-19 symptoms, and required greater hospital resources compared to those without obesity, highlighting the need for tailored preventive measures.
Objectives: To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children and adolescents diagnosed or hospitalized with coronavirus disease 2019 (COVID-19) and to compare them in secondary analyses with patients diagnosed with previous seasonal influenza in 2017-2018.
Methods: International network cohort using real-world data from European primary care records (France, Germany, and Spain), South Korean claims and US claims, and hospital databases. We included children and adolescents diagnosed and/or hospitalized with COVID-19 at age <18 between January and June 2020.
Article Synopsis
- The study investigated whether alpha-1 blockers, typically used for treating benign prostate hyperplasia (BPH), can reduce the risk of complications from COVID-19, particularly by blocking cytokine storms.
- Researchers compared 2.6 million alpha-1 blocker users with 0.46 million users of alternative BPH treatments from electronic health records in Spain and the U.S. between November 2019 and January 2020.
- The results showed no significant difference in the risks of COVID-19 diagnosis, hospitalization, or need for intensive services between the two groups, highlighting the necessity for additional research on potential therapies for COVID-19.
Article Synopsis
- The study aimed to assess the 30-day outcomes and mortality of patients with autoimmune diseases hospitalized due to COVID-19, comparing them to similar hospital patients with seasonal influenza.
- Researchers analyzed data from multiple health institutions and found that most patients were older females with significant comorbidities.
- Results indicated that COVID-19 led to more respiratory complications and higher mortality rates (up to 24.6%) compared to influenza (up to 4.3%).
Article Synopsis
- Routinely collected real-world data (RWD) is essential for understanding and responding to the COVID-19 pandemic, as demonstrated by the CHARYBDIS framework for standardizing and analyzing this data.
- A descriptive cohort study involving over 4.5 million individuals was conducted across the U.S., Europe, and Asia to examine COVID-19-related health risks and outcomes, with detailed information available on an interactive website.
- The findings from the CHARYBDIS study serve as benchmarks to enhance our knowledge of COVID-19's progression and management, facilitating timely evaluations of new preventative and therapeutic strategies.