A5089105344- Heart Failure Treatment and Management
- Asthma and respiratory diseases
- Statistical Methods in Clinical Trials
- Pharmacovigilance and Adverse Drug Reactions
- Blood Pressure and Hypertension Studies
- Venous Thromboembolism Diagnosis and Management
- Maternal and fetal healthcare
- Pregnancy and Medication Impact
- Atrial Fibrillation Management and Outcomes
- Medication Adherence and Compliance
- Long-Term Effects of COVID-19
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Advanced Causal Inference Techniques
- Biosimilars and Bioanalytical Methods
- Health Systems, Economic Evaluations, Quality of Life
- Emergency and Acute Care Studies
- Technology and Data Analysis
- Pharmaceutical Practices and Patient Outcomes
- Suicide and Self-Harm Studies
- Ectopic Pregnancy Diagnosis and Management
- Anesthesia and Pain Management
- Global Health Care Issues
- Blood Coagulation and Thrombosis Mechanisms
- Nonmelanoma Skin Cancer Studies
- Pharmaceutical studies and practices
United States Food and Drug Administration
2016-2024
Center for Drug Evaluation and Research
2015-2024
IQVIA (United States)
2023-2024
Statistics Canada
2024
IQ Solutions
2023-2024
Government of the United States of America
2022
Harvard Pilgrim Health Care
2021
Harvard University
2021
Center for Biologics Evaluation and Research
2021
Food and Drug Administration
2016-2021
Objectives To examine valsartan, losartan and irbesartan usage switching patterns in the USA, UK, Canada Denmark before after July 2018, when first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled. Design Retrospective cohort study. Setting Canadian administrative healthcare data, Danish National Prescription Registry UK primary care electronic health records. Participants Patients aged 18 years older between January 2014 December 2020. Intervention Valsartan, irbesartan. Main...
Unmeasured confounding is often raised as a source of potential bias during the design nonrandomized studies, but quantifying such concerns challenging. We developed simulation-based approach to assess impact unmeasured study stage. The involved generation hypothetical individual-level cohorts using realistic parameters, including binary treatment (prevalence 25%), time-to-event outcome (incidence 5%), 13 measured covariates, confounder (u1; 10%), and "proxy" variable (p1) correlated with...
European studies reported an increased risk of nonmelanoma skin cancer associated with hydrochlorothiazide (HCTZ)-containing products. We examined the risks basal cell carcinoma (BCC) and squamous (SCC) HCTZ compared angiotensin-converting enzyme inhibitors (ACEIs) in a US population.
Abstract Background Evidence on the effectiveness of respiratory syncytial virus (RSV) immunoprophylaxis with palivizumab in children cystic fibrosis (CF) is lacking. Methods We utilized Medicaid Extract files from 27 states 1999 to 2006 linked National Cystic Fibrosis Registry establish a cohort 0–2 years CF diagnosis. Eligible entered after diagnosis and RSV season onset, were followed until end, second birthday, death, or hospitalizations for reasons other then study outcome. Two outcomes...
To identify factors that explain differences in HPV vaccination rates for male and female adolescents to determine self-reported barriers by parents affecting decisions. The sample included 13–17 years old with a record documented the 2012 2013 National Immunization Survey-Teen dataset. A logistic regression model was developed 13 socio-demographic survey year, along significant interaction pairs gender. Subjects 20,355 18,350 adolescent boys girls, respectively. About half of females (56%)...
Background Epidural corticosteroid injections (ESIs) are widely performed and have an unquantified risk of serious spinal adverse events (SSAEs). We sought to determine the rate SSAEs following ESI compare rates by level, injection approach formulation. Methods included patients enrolled in Medicare parts A B who had between 1 January 2009 30 September 2015. identified potential cases as with spine-related diagnoses within 3 days after first eligible ESI. Event categorization probable,...
Abstract We conducted retrospective public health surveillance using data from 2006 to 2016 in seven integrated delivery systems FDA’s Sentinel System. identified pediatric hypertensive patients by clinical and claims-based definitions compared demographics, baseline profiles follow-up time profiles. Among 3,757,803 aged 3 17 years, we 781,722 children 551,246 teens with at least three blood pressure measures over 36-months. Of these, 70,315 (9%) 47,928 (8.7%) met the definition for...
Abstract Purpose To describe the use of tumor necrosis factor‐alpha inhibitors (TNFis) among pregnancies ending in a live birth and with diagnosis ankylosing spondylitis (AS), Crohn's disease (CD), juvenile idiopathic arthritis (JIA), psoriasis (PsO), psoriatic (PsA), rheumatoid (RA), or ulcerative colitis (UC). Methods We identified women aged 15 to 54 years between 01/01/2004 09/30/2015 from 16 health plans participating Sentinel. inferred indication using ICD‐9‐CM codes 183‐day period...
Abstract We used social media data from “covid19positive” subreddit, 03/2020 to 03/2022 identify COVID-19 cases and extract their reported symptoms automatically using natural language processing (NLP). trained a Bidirectional Encoder Representations Transformers classification model with chunking cases; also, we developed novel QuadArm model, which incorporates Question-answering, dual-corpus expansion, Adaptive rotation clustering, mapping, symptoms. Our achieved 91.2% accuracy for the...
ABSTRACT Purpose To develop and validate an algorithm to identify preterm infants in the absence of birth certificates within Medicaid data. Methods fee‐for‐service claims data from Florida (FL) Texas (TX) were linked vital statistics for who continuously eligible during first 3 months following or died that period. Prematurity was defined as less than 34 weeks gestational age. Using FL exploratory dataset gold standard, we developed a logistic regression model diagnostic procedure codes...
Regulators are increasingly concerned with the impact of recalls on drug adherence. In 2018, N-nitrosamines impurities were detected in valsartan containing medical products. Concerned products immediately recalled July 2018 by regulatory agencies internationally. Germany, issued for valsartan, losartan and irbesartan from to March 2019. This study examined angiotensin II receptor blocker (ARB) utilization trends switching patterns Germany before after 2018.Patients prescribed ARBs January...
The tree-based scan statistic (TreeScan; Martin Kulldorff, Harvard Medical School, Boston, Massachusetts) is a data-mining method that adjusts for multiple testing of correlated hypotheses when screening thousands potential adverse events signal identification. Simulation has demonstrated the promise TreeScan with propensity score (PS)-matched cohort design. However, it unclear which variables to include in PS applied identification studies simultaneously adjust confounding across outcomes....
Montelukast prescribing information includes a Boxed Warning issued in March 2020 regarding neuropsychiatric adverse events. A previous Sentinel System study of asthma patients from 2000 to 2015 did not demonstrate an increased risk intentional self-harm measured using the International Classification Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes, with montelukast compared inhaled corticosteroids (ICS).
Abstract Purpose To describe utilization of filgrastim and infliximab, the first two products with biosimilars approved in United States. Methods We identified use (reference, tbo‐filgrastim, filgrastim‐sndz) infliximab infliximab‐dyyb, infliximab‐abda) Sentinel Distributed Database using Healthcare Common Procedure Coding System (HCPCS) codes National Drug Codes (NDCs) from January 2015 to August 2018. calculated proportion by code type assessed uptake over time. compared baseline patient...
Cutaneous small vessel vasculitis (CSVV) has been reported after exposure to direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, and edoxaban.