- Health Systems, Economic Evaluations, Quality of Life
- Pharmacovigilance and Adverse Drug Reactions
- COVID-19 Clinical Research Studies
- SARS-CoV-2 and COVID-19 Research
- Spinal Fractures and Fixation Techniques
- Spine and Intervertebral Disc Pathology
- Pharmaceutical Practices and Patient Outcomes
- Meta-analysis and systematic reviews
- Orthopaedic implants and arthroplasty
- Cardiac, Anesthesia and Surgical Outcomes
- Spinal Hematomas and Complications
- Drug-Induced Adverse Reactions
- Autoimmune and Inflammatory Disorders Research
- Metal Forming Simulation Techniques
- Bacterial Infections and Vaccines
- Delphi Technique in Research
- Opioid Use Disorder Treatment
- Iron Metabolism and Disorders
- Medical Imaging and Analysis
- Pharmacological Effects and Toxicity Studies
- Adolescent and Pediatric Healthcare
- Metallurgy and Material Forming
- Statistical Methods in Clinical Trials
- Chemotherapy-induced cardiotoxicity and mitigation
- COVID-19 Impact on Reproduction
Pfizer (United States)
2015-2024
CVS Health (United States)
2023
Anthem (United States)
2023
Pfizer (United Kingdom)
2023
Beihang University
2003-2007
Real-world evidence (RWE) is increasingly used for medical regulatory decisions, yet concerns persist regarding its reproducibility and hence validity. This study addresses challenges associated with diversity across real-world data sources (RWDS) repurposed secondary use in pharmacoepidemiologic studies. Our aims were to identify, describe characterize practices, recommendations tools collecting reporting RWDSs, explore how leveraging could improve the quality of evidence.
ObjectiveDisruptive mood dysregulation disorder (DMDD) was introduced in DSM-5 to distinguish a subset of chronically irritable youth who may be incorrectly diagnosed and/or treated for pediatric bipolar (BPD). This study characterized the rate new treatment episodes and prevalence BPD DMDD from longitudinal electronic health record database examined impact on prescription trends.MethodA retrospective cohort using 2008-2018 Optum data conducted. Youth aged 10 < 18 years with ≥ 183 days...
Objective To describe characteristics and coronavirus disease 2019 (COVID-19) clinical outcomes of patients with rheumatoid arthritis (RA), psoriatic (PsA), or ulcerative colitis (UC) receiving systemic therapies vs the general population. Methods This descriptive retrospective cohort study used data from United States Optum deidentified COVID-19 electronic health record dataset (2007–2020). Adults were stratified into 3 cohorts (patients RA, PsA, UC who had received therapy) a comparator...
Abstract Objectives The aim of this analysis was to describe nirmatrelvir/ritonavir real-world effectiveness in preventing hospitalization among high-risk US COVID-19 patients during SARS-CoV-2 Omicron predominance. Design An ongoing population-based cohort study with retrospective and prospective collection electronic healthcare data the United States. Methods Data for were collected from Optum® de-identified Electronic Health Record (EHR) dataset December 22, 2021−June 8, 2022. Key...
Aim In Europe, pregabalin is approved for treatment of neuropathic pain, general anxiety disorder (GAD) and as adjunctive therapy epilepsy. The purpose this study was to assess utilisation in the UK, including patients with a recorded history substance abuse, from large practice database. Methods This observational drug (DUS) analysed prescription data UK Health Improvement Network primary care database between September 2004 July 2009. Patient demographics, diagnoses (by READ codes) dosing...
Abstract Purpose It is well documented that outcome misclassification can bias a point estimate. We aimed to understand current practice in addressing this pharmacoepidemiology database studies and develop an open source application (app) from existing methodology demonstrate the impact mechanism of on results. Methods Studies exposure clinical were selected all Pharmacoepidemiology Drug Safety publications during 2017 any reference described. An app correct risk ratio (RR) cumulative...
Abstract Objective To assess the risk of select safety outcomes including endometrial cancer, hyperplasia, and breast cancer among women using conjugated estrogens/bazedoxifene (CE/BZA) as compared with estrogen/progestin combination hormone therapy (EP). Methods We conducted a new-user cohort study in five US healthcare claims databases representing more than 92 million women. included CE/BZA or EP new users from May 1, 2014, to August 30, 2019. were propensity score (PS) matched CE/BZA....
The routine use of sequential methods is well established in clinical studies. Recently, there has been increasing interest applying these to prospectively monitor the safety newly approved drugs through accrual real-world data. However, application marketed using data limited and work needed determine which approaches are most suited such In this study, conditional sampling procedure (CSSP), a group method, was compared with log-linear model Poisson distribution (LLMP) SAS (PROC GENMOD)...
Abstract Background Although stroke is a rare complication among spinal surgery patients, the recognition of this adverse event critical given aging population undergoing surgical procedures. The objective study was to estimate incidence selected adults elective posterior lumbar fusion (PLF) during various post-operative risk windows and different subgroups. Methods A retrospective cohort using longitudinal electronic healthcare record (EHR) database conducted from January 1, 2007 June 30,...
Abstract Background Acute myocardial infarction (AMI) is an uncommon but fatal complication among patients undergoing elective spinal fusion surgery (SF), total hip arthroplasty (THA), and knee (TKA). Our objective was to estimate the incidence of AMI adults SF, THA, TKA in different post-operative risk windows characterize high-risk sub-populations United States. Methods A retrospective cohort study conducted using data from a longitudinal electronic healthcare record (EHR) database January...
Purpose: We describe nirmatrelvir/ritonavir (NMV/r) effectiveness in preventing hospitalization among COVID-19 patients at high risk of severe disease. Methods: An ongoing US population-based observational cohort study with retrospective and prospective collection national electronic healthcare data collected from the Optum® de-identified Electronic Health Record dataset during December 22, 2021−July 20, 2022. Participants were ≥12 years old; had a positive SARS-CoV-2 test, diagnosis, or...
Abstract BACKGROUND & AIMS Wilson’s disease (WD) is a rare genetic disorder causing excessive copper accumulation. Research on the natural history of WD limited. Our objective was to identify predictors for progression cirrhosis, liver failure, and death predict individual risk these endpoints at 1, 2, 3, 5 years after diagnosis. METHODS A retrospective cohort study adult patients with first-recorded diagnosis conducted using US Optum EHR data between 1/1/2007 6/30/2020. LASSO Cox...