Publications & Presentations

Sentinel is committed to publishing findings in journals and sharing information at relevant conferences.  The following table provides summary information about Sentinel activities that have appeared in peer-reviewed journals or in conference materials.

Search Publications & Presentations

Title Date Posted
Scalable Phenotyping for Safety Outcomes Using Electronic Health Record Data
Presentation
11/17/2022
Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning
Publication
11/04/2022
A New Analytic Tool for Assessing the Impact of the US Food and Drug Administration Regulatory Actions
Publication
11/04/2022
Spironolactone Utilization among Patients with Reduced and Preserved Ejection Fraction Heart Failure
Publication
10/20/2022
Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
Presentation
10/20/2022
Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs
Publication
10/18/2022
COVID-19 Real-World Evidence Primer
Publication
09/23/2022
How Big Data Support Post Marketing Surveillance in USA: The Sentinel Initiative
Presentation
09/22/2022
Should Insulin Billing Procedure Codes be Considered for Exposure Ascertainment in Pharmacoepidemiology Studies?
Publication
09/21/2022
Describing Prenatal Exposures and Evaluating Maternal and Infant Outcomes in Sentinel
Presentation
09/13/2022
The US Food and Drug Administration Sentinel System: A National Resource for a Learning Health System
Publication
09/12/2022
Characterizing Pediatric Members in the Sentinel Distributed Database
Presentation
08/28/2022
Characterizing Infants in the Sentinel Distributed Database Mother-Infant Linkage Table
Presentation
08/28/2022
Identification of Obesity and Tobacco Use in Claims Compared to Electronic Health Record (EHR) Data
Presentation
08/28/2022
Data-Driven Approaches to Improve Phenotype Sensitivity Using EHR Data
Presentation
08/28/2022
Use of Valganciclovir/Ganciclovir [(v)GCV] for Treatment of Congenital Cytomegalovirus (cCMV) Infection in the United States: Evidence from the Sentinel Distributed Database, 2008-2020
Presentation
08/28/2022
Racial Differences in U.S. COVID-19 Positivity, Hospitalization, and Mortality
Presentation
08/28/2022
Systemic Corticosteroids for COVID-19 in U.S. Outpatient Settings
Presentation
08/28/2022
What Do Real World Data Validation Best Practices Look Like? Operationalizing Guidance for Real-World Studies Intended for Decision-Making
Presentation
08/28/2022
Switching Patterns of Mixed Amphetamine Salt Products in the FDA’s Sentinel Distributed Database
Presentation
08/27/2022
Comparative Evaluation of Automated Approaches for Confounder Selection in High-Dimensional Data with Rare Outcomes
Presentation
08/27/2022
Arterial and Venous Thrombotic Events in Patients with COVID-19 Compared to Influenza
Presentation
08/27/2022
Design Considerations for Using the Tree-based Scan Statistic in Surveillance of Maternal Outcomes Following Medication Use during Gestation
Presentation
08/26/2022
Impact of Nitrosamine Contamination Recalls on Angiotensin-Receptor-Blocker (ARB) Utilization in the U.S., U.K., Canada, and Denmark
Presentation
08/26/2022
Leuprolide and Fracture Risk in Patients with Central Precocious Puberty
Presentation
08/26/2022
Inverse Probability Treatment Weighting Versus Propensity Score Matching in the Sentinel System: A Test Case
Presentation
08/26/2022
Characterizing Medication Use Among Pregnancies with COVID-19 in the Sentinel System
Presentation
08/26/2022
Data Harmonization, Standardization, and Quality Assessment in Distributed Health Data Networks: Lessons from Around the World
Presentation
08/26/2022
Methods and Considerations for Hypothesis-Free Signal Detection Studies Accommodating Various Types of Medications, Populations and Regions
Presentation
08/26/2022
Validation of Acute Pancreatitis Among Adults in an Integrated Healthcare System
Publication
08/22/2022
Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
Publication
08/16/2022
Using TreeScan as a Signal Identification Approach to Screen for Adverse Maternal Outcomes of Medication Use in Pregnancy
Presentation
08/09/2022
A Cohort Study to Assess Risk of Cutaneous Small Vessel Vasculitis Among Users of Different Oral Anticoagulants
Publication
07/31/2022
Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System
Publication
07/24/2022
New-Onset Cancer Cases in FDA’s Sentinel System: A Large Distributed System of US Electronic Healthcare Data
Publication
07/15/2022
Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics
Presentation
06/28/2022
Scalable Algorithm Development: An Alternative to Algorithm Reuse?
Presentation
05/17/2022
Use of Real-World Data for Surveillance of Medications in Pregnancy
Presentation
05/09/2022
Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021
Publication
04/08/2022
A Landscape Analysis of Valganciclovir Treatment for Congenital Cytomegalovirus Infection in the United States (US), 2008-2021
Presentation
03/28/2022
CNODES Webinar: Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics
Presentation
03/09/2022
Utility of Fertility Procedures and Prenatal Tests to Estimate Gestational Age for Live-births and Stillbirths in Electronic Health Plan Databases
Publication
02/05/2022
Evaluating Confounding Control in Estimations of Influenza Antiviral Effectiveness in Electronic Health Plan Data
Publication
02/02/2022
Real-World Data: Data Networks, Standardization, and Federated Analysis
Presentation
01/18/2022
Broadening the Reach of the FDA Sentinel System: A Roadmap for Integrating Electronic Health Record Data in a Causal Analysis Framework
Publication
12/20/2021
Validation of Diagnosis Codes to Identify Hospitalized COVID-19 Patients in Health Care Claims Data
Publication
12/16/2021
Self‑Controlled Assessment of Thromboembolic Event (TEE) Risk Following Intravenous Immune Globulin (IGIV) in the U.S. (2006–2012)
Publication
11/24/2021
Emerging Technologies and Their Impact on Regulatory Science
Publication
11/16/2021
Reliable Insights Regarding Medication Outcomes From Real World Data – Key Principles of an Evidence Generation Framework
Presentation
11/01/2021
Using Inpatient Electronic Medical Records to Study Influenza for Pandemic Preparedness
Publication
10/25/2021
Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network
Publication
10/14/2021
Natural History of Coagulopathy in COVID-19
Presentation
10/06/2021
Risk of Hospitalized Depression and Intentional Self-Harm with Brand and Authorized Generic Sertraline
Publication
10/05/2021
Monitoring Medication Use During the COVID-19 Pandemic in the Sentinel System: The Case of Anticoagulation for Thrombosis
Presentation
09/15/2021
Incidence of Severe Uterine Bleeding Outcomes among Oral Anticoagulant Users and Nonusers
Publication
09/01/2021
Characteristics and Outcomes of Pregnancies in Women with Heart Failure: A Retrospective Cohort Study in the Sentinel Distributed Database
Presentation
08/25/2021
Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning
Presentation
08/25/2021
Strategies for the Use of Real-World Data to Conduct COVID-19-Related Pharmacoepidemiology
Presentation
08/25/2021
A New Analytic Tool for Interrupted Times Series Analysis to Assess the Impact of FDA Regulatory Actions
Presentation
08/24/2021
No Differential Risk of Cutaneous Small Vessel Vasculitis with Oral Anticoagulant Use Among Patients with Atrial Fibrillation
Presentation
08/24/2021
New Frontiers in Computable Phenotyping for Medical Product Safety Evaluation
Presentation
08/24/2021
Early Uptake of New Molecular Entities Approved in 2017 in a Multisite National US Healthcare Data Network
Presentation
08/23/2021
Outpatient-Identified COVID-19 and Subsequent Hospitalized Thrombotic Events
Presentation
08/23/2021
Comparing Outcomes in Trial-Eligible vs Real-World COVID-19 Patients: The Case of Invasive Mechanical Ventilation
Presentation
08/23/2021
Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network: The Sentinel Distributed Database Mother-Infant Linkage Table
Presentation
08/23/2021
Pregnancy in Women with Heart Failure: A Cross-Sectional Study in the Sentinel Distributed Database
Presentation
08/23/2021
How Under-Coded is Pediatric Hypertension?: Comparison of Claims and Electronic Health Record (EHR) Data 
Presentation
08/23/2021
Post-Keratoplasty Fungal Keratitis in the Sentinel Distributed Database: Prevalence and Time Trends
Presentation
08/23/2021
Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: A Propensity Score Matched Case Study
Presentation
08/23/2021
Statistical Power for Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use
Presentation
08/23/2021
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research
Presentation
08/23/2021
Who Gets Treated for Influenza: A Surveillance Study From the US Food and Drug Administration’s Sentinel System
Publication
08/05/2021
The Sentinel Experience
Presentation
07/10/2021
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research
Publication
07/03/2021
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data
Presentation
06/29/2021
Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System
Publication
06/04/2021
Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin
Publication
05/20/2021
Utilization of Hydroxyprogesterone Caproate among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database
Publication
04/29/2021
Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM
Publication
04/26/2021
Validity of ICD‐10‐CM Diagnoses to Identify Hospitalizations for Serious Infections Among Patients Treated With Biologic Therapies
Publication
04/22/2021
A COVID‐19‐Ready Public Health Surveillance System: The FDA's Sentinel System
Publication
04/02/2021
Electronic Phenotyping of Health Outcomes of Interest Using a Linked Claims-Electronic Health Record Database: Findings from a Machine Learning Pilot Project
Publication
03/12/2021
A General Propensity Score for Signal Identification using Tree-Based Scan Statistics
Publication
02/22/2021
Community Building and Outreach Center (CBOC) Master Plan
Publication
02/10/2021
Innovation Center (IC) Master Plan
Publication
02/10/2021
Risk of Non-Melanoma Skin Cancer in Association with Use of Hydrochlorothiazide-Containing Products in the United States
Publication
02/04/2021
Identification and Validation of Anaphylaxis Using Electronic Health Data in a Population-Based Setting
Publication
02/02/2021
Medical Chart Validation of Inpatient Diagnosis Codes for Transfusion‐Related Acute Lung Injury 2013‐2015
Publication
01/27/2021
Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM
Presentation
12/15/2020
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data
Presentation
12/15/2020
The FDA MyStudies App: A Reusable Platform for Distributed Clinical Trials and Real-World Evidence Studies
Publication
12/11/2020
Validation of Claims-based Algorithms to Identify Hospitalized COVID-19 Events within the FDA Sentinel System
Presentation
12/02/2020
Incidence of Uterine Bleeding following Oral Anticoagulant Use in Food and Drug Administration’s Sentinel System
Publication
11/26/2020
Antipsychotic Medication Use Among Hospitalized Infants Using Inpatient Data in FDA’s Sentinel System
Presentation
11/17/2020
Functional Clustering Methods for Longitudinal Data with Application to Electronic Health Records
Publication
11/11/2020
Natural History of Coagulopathy in Patients with COVID-19 in a Real-World Electronic Health Data Network
Presentation
11/05/2020
Descriptive Assessment of Coagulopathy Among COVID-19 Patients: Feasibility Data Review
Presentation
10/27/2020
Natural History of Coagulopathy in COVID-19
Presentation
10/26/2020
Leveraging the Capabilities of the FDA’s Sentinel System To Improve Kidney Care
Publication
10/19/2020
Studying the Natural History of COVID-19: Risk of Arterial and Venous Thrombotic Events in the Sentinel System
Presentation
10/14/2020
Leveraging the Sentinel System for COVID-19
Presentation
10/14/2020
When Decisions Can't Wait: Delivering Rapid Real World Studies
Presentation
10/13/2020
Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis
Publication
10/08/2020
Phosphodiesterase Type 5 Inhibitor Use Among Pregnant and Reproductive‐Age Women in the United States
Publication
10/05/2020
Risk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin
Publication
09/28/2020
Utilization of Spironolactone in Patients with Reduced or Preserved Ejection Fraction Heart Failure
Presentation
09/23/2020
Utilization of Sacubitril/Valsartan in Real-World Settings
Presentation
09/23/2020
Risk of Neuropsychiatric Adverse Events among Montelukast Users
Presentation
09/23/2020
Comparative Risk Assessment of Severe Abnormal Uterine Bleeding associated with Non-Vitamin K Oral Anticoagulants
Presentation
09/22/2020
Replicating the Findings of a Medicare Study on Stroke, and Bleeding Risk in Patients Using NOACs for Atrial Fibrillation in the Sentinel System
Presentation
09/22/2020
Use of Hydroxyprogesterone Caproate and Progesterone During the 2nd and/or 3rd Trimester Among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database
Presentation
09/22/2020
Utilization Characteristics for Inhaled Corticosteroid‐based Asthma Medications in the Sentinel System, 2008‐2019
Presentation
09/22/2020
Factors Related to Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) and Dipeptidyl Peptidase 4 Inhibitor (DPP4i) Dispensing among Naive, Incident, and Prevalent New Users
Presentation
09/21/2020
Assessing the Feasibility of Evaluating Tacrolimus Use after Solid Organ Transplantation in the Sentinel Distributed Database
Presentation
09/21/2020
Risk of Non-Melanoma Skin Cancer Associated with Hydrochlorothiazide-Containing Products in the United States
Presentation
09/21/2020
Incidence of Severe Abnormal Uterine Bleeding Following Oral Anticoagulant Use
Presentation
09/21/2020
Utilization of IV Iron among Pregnant Women with Live Births or Stillbirths; A Study in the Sentinel Distributed Database
Presentation
09/20/2020
Antipsychotic Medication Use among Hospitalized Infants Using Inpatient Data in FDA’s Sentinel System
Presentation
09/20/2020
Risk of Stroke and Bleeding in Nonvalvular Atrial Fibrillation Treated with Apixaban Compared to Warfarin in the Sentinel System
Presentation
09/20/2020
Incidence of Cutaneous Small Vessel Vasculitis associated with Oral Anticoagulant Use
Presentation
09/20/2020
Comparing Three Signal Identification Methods with Self-Controlled Designs
Presentation
09/17/2020
Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System
Presentation
09/17/2020
Asthma Maintenance Medication Users in the Sentinel System
Presentation
09/17/2020
Percutaneous Transluminal Septal Myocardial Ablation and Common Procedural Complications: A Descriptive Study
Presentation
09/17/2020
Replication of Protocol-Based Analyses of Saxagliptin and Sitagliptin using Sentinel Modular Programs
Presentation
09/17/2020
Incidence of Ocular Adverse Events Associated with Mometasone Implants among Patients with Nasal Polyposis
Presentation
09/17/2020
Improving Identification of Anaphylaxis
Presentation
09/17/2020
Assessing Data Source Characteristics in Multi-site Analyses
Presentation
09/08/2020
Utilization of Sacubitril/Valsartan in Real-World Settings
Publication
08/24/2020
Defining COVID-19 Cohorts in Real-World Data
Presentation
08/18/2020
Risk of Psychiatric Adverse Events among Montelukast Users
Publication
08/11/2020
Consequences of Depletion of Susceptibles for Hazard Ratio Estimators Based on Propensity Scores
Publication
08/06/2020
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Focus on Endpoints
Presentation
08/04/2020
Underuse of Oral anticoagulants in privately insured patients with atrial fibrillation: A population targeted by IMplementation of a randomized controlled trial to ImProve treatment with Oral AntiCoagulanTs in atrial fibrillation patients (IMPACT-AFib)
Publication
07/24/2020
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Update on Methods
Presentation
07/14/2020
Practical Challenges in the Conduct of Pragmatic Trials Embedded in Health Plans: Lessons of IMPACT-AFib, an FDA-Catalyst Trial
Publication
06/26/2020
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Potential Aims/Methods
Presentation
06/23/2020
Coagulopathy Assessment in Patients with COVID-19: A TriNetX Analysis
Presentation
06/23/2020
Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer
Presentation
06/11/2020
Concomitant Filled Prescriptions of Oxymorphone or Oxycodone with CYP3A Inhibitors and Inducers
Publication
05/26/2020
Conducting Prospective Sequential Surveillance in Real‐World Dynamic Distributed Databases
Publication
05/25/2020
Assessing Natural History, Drug Use and Treatment Impact for COVID-19 in the Sentinel System
Presentation
05/13/2020
Using and Improving Distributed Data Networks to Generate Actionable Evidence: the Case of Real-World Outcomes in the Food and Drug Administration’s Sentinel System
Publication
04/11/2020
Distributed Regression Analysis Application in Large Distributed Data Networks: Analysis of Precision and Operational Performance
Publication
04/06/2020
Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer
Presentation
03/05/2020
Sentinel Mother-Infant Linkage and Pregnancy Analyses
Presentation
02/19/2020
Translating Claims‐Based CHA2DS2‐VaSc and HAS‐BLED to ICD‐10‐CM: Impacts of Mapping Strategies
Publication
02/17/2020
The Risk of Febrile Seizures following Influenza and 13-Valent Pneumococcal Conjugate Vaccines
Publication
01/31/2020
Understanding Utilization Patterns of Biologics and Biosimilars in the United States to Support Postmarketing Studies of Safety and Effectiveness
Publication
12/11/2019
Medical Product Safety Surveillance: Data Quality in the Sentinel Initiative
Presentation
12/02/2019
Use of Antidiabetic Drugs During Pregnancy among U.S. Women with Livebirth Deliveries in the Mini-Sentinel System
Publication
11/27/2019
Redesigning PopMedNet for Distributed Regression Analysis with Vertically Partitioned Data
Presentation
11/19/2019
Quantifying How Small Variations in Design Elements Affect Risk in an Incident Cohort Study in Claims
Publication
11/17/2019
Myopathy and Rhabdomyolysis with Concomitant Use of Ticagrelor and High-Intensity Statins in the Elderly
Presentation
11/14/2019
Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy
Publication
10/22/2019
Reproducing Protocol‐based Studies Using Parameterizable Tools – Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks
Publication
10/19/2019
Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis
Publication
10/10/2019
Use of Time-Dependent Propensity Scores to Adjust Hazard Ratio Estimates in Cohort Studies with Differential Depletion of Susceptibles
Publication
09/26/2019
Identification of Potential Drug Name Confusion Errors in the Sentinel System
Publication
09/04/2019
Characteristics and Treatment Status of Those with Influenza-Like Illness: Implications for Effectiveness Studies and Surveillance
Presentation
08/27/2019
Utilization of Prescription Anti-Obesity Drugs in the U.S. Food and Drug Administration's (FDA) Sentinel System, 2008-2017
Presentation
08/27/2019
Identification of Ordinal Endpoints Indicating Influenza Complications: A Feasibility Analysis Relevant to the Study of Medical Countermeasures
Presentation
08/27/2019
Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis
Presentation
08/27/2019
Biosimilar Use in the United States: A Sentinel Analysis of Filgrastim and Infliximab
Presentation
08/27/2019
Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy
Presentation
08/27/2019
Utility of Prenatal Tests and Fertility Coding to Estimate Pregnancy Start in the Sentinel Distributed Database
Presentation
08/26/2019
Duration of Follow-up of Chronic Condition Cohorts in the Sentinel System
Presentation
08/26/2019
13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Kawasaki Disease
Presentation
08/26/2019
Confounding Variable Capture in Large Healthcare Administrative Claims Database: A Trend Analysis in the Sentinel System
Presentation
08/26/2019
Evidence of Residual Confounding in Healthcare Database Studies of Oseltamivir and Influenza Complications
Presentation
08/25/2019
Exposure to N-nitrosodimethylamine (NDMA)/N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States
Presentation
08/25/2019
Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings
Presentation
08/25/2019
A General Propensity Score for Signal Detection using Tree-Based Scan Statistics
Presentation
08/25/2019
Thinking Globally While Acting Locally: Developing Time-on-Treatment Data In International Settings
Presentation
08/25/2019
Experience from US FDA Sentinel Initiative Studies
Presentation
08/25/2019
Phosphodiesterase Type 5 (PDE-5) Inhibitor Use Among Pregnant Women and Women of Reproductive Age in the United States
Presentation
08/25/2019
Epidemiology of Pediatric Respiratory Syncytial Virus-Associated Illnesses in Young Children
Presentation
08/25/2019
Characteristics of NOAC Users Aged Less Than 65 Years in the Sentinel System
Presentation
08/25/2019
Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis
Presentation
08/25/2019
Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations
Publication
08/20/2019
First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies
Publication
08/20/2019
Development of an Algorithm to Detect Methotrexate Wrong Frequency Error Using Computerized Health Care Data
Publication
08/13/2019
Kawasaki Disease and 13-Valent Pneumococcal Conjugate Vaccination Among Young Children: A Self-Controlled Risk Interval and Cohort Study with Null Results
Publication
07/02/2019
Signal Identification Methods in the Sentinel System
Presentation
06/12/2019
Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program
Publication
06/08/2019
Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population
Publication
06/04/2019
Medical Product Safety: Ten Years of the U.S. Sentinel System
Presentation
05/23/2019
Evaluation of Use of Technologies to Facilitate Medical Chart Review
Publication
05/20/2019
Leveraging the Entire Cohort in Drug Safety Monitoring: Part 1 Methods for Sequential Surveillance that Use Regression Adjustment or Weighting to Control Confounding in a Multi-Site, Rare Event, Distributed Data Setting
Publication
05/17/2019
Applying Sequential Surveillance Methods That Use Regression Adjustment or Weighting to Control Confounding in a Multi-Site, Rare Event, Distributed Setting: Part 2 In-Depth Example of a Re-Analysis of the MMRV Combination Vaccine and Seizure Risk
Publication
05/02/2019
Evaluating the Use of Bootstrapping in Cohort Studies Conducted with 1:1 Propensity Score Matching — A Plasmode Simulation Study
Publication
04/24/2019
The Devil's in the Details: Reports on Reproducibility in Pharmacoepidemiologic Studies
Publication
03/06/2019
Evidence from Real-World Data Sentinel Initiative of U.S. FDA
Presentation
02/20/2019
Cross‐Network Directory Service: Infrastructure to Enable Collaborations Across Distributed Research Networks
Publication
02/14/2019
A New Analytic Tool Developed in the Sentinel System to Assess Safe Use Recommendations
Publication
02/12/2019
Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure
Publication
02/08/2019
Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users
Publication
01/19/2019
How Pharmacoepidemiology Networks Can Manage Distributed Analyses to Improve Replicability and Transparency and Minimize Bias
Publication
01/15/2019
Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel
Presentation
11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10
Presentation
11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System
Presentation
11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App
Presentation
11/29/2018
The FDA Sentinel Initiative — An Evolving National Resource
Publication
11/29/2018
Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review
Publication
11/23/2018
FDA-Catalyst - Using FDA's Sentinel Initiative for Large-Scale Pragmatic Randomized Trials: Approach and Lessons Learned During the Planning Phase of the First Trial
Publication
11/19/2018
Use of Tumor Necrosis Factor-alpha Inhibitors During Pregnancy Among Women Who Delivered Liveborn Infants
Publication
11/14/2018
Overall and Cause-Specific Mortality in the Sentinel System: A Power Analysis
Publication
11/13/2018
A Generalizable Smartphone-Based Clinical Research Platform
Presentation
11/05/2018
Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance
Presentation
11/04/2018
Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System
Publication
10/31/2018
Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative
Presentation
10/19/2018
Misclassification in Assessment of First Trimester In-Utero Exposure to Drugs used Proximally to Conception - The Example of Letrozole Utilization for Infertility Treatment
Publication
10/15/2018
Association of Risk for Venous Thromboembolism With Use of Low-Dose Extended- and Continuous-Cycle Combined Oral Contraceptives: A Safety Study Using the Sentinel Distributed Database
Publication
10/01/2018
International Comparison of Approaches to Common Data Models for Comparative Effectiveness Research
Presentation
09/12/2018
Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System
Publication
08/28/2018
Validation of Transfusion Administrations Among Potential Transfusion-Related Acute Lung Injury (TRALI) Patients Included in the Sentinel Distributed Database
Presentation
08/25/2018
Assessment of Transfusion-Related Acute Lung Injury (TRALI) after Blood Transfusion
Presentation
08/24/2018
Misclassification of Time-at-Risk Due to Free Drug Sample Use: A Simulation Study
Presentation
08/22/2018
Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic
Presentation
08/22/2018
First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies
Presentation
08/22/2018
Using Time-Dependent Propensity Scores to Correct for Differential Depletion of Susceptibles when Estimating Hazard Ratios in Time-to-Event Data
Presentation
08/22/2018
Assessing the Impact of the New U.S. ICD-10-CM Coding System on Pharmacoepidemiologic Studies: An Application Between Angiotensin-Converting Enzyme Inhibitors and Angioedema
Presentation
08/21/2018
Early Lessons on ICD-10-CM/PCS Transition in Claims-Based Drug Safety Assessments
Presentation
08/21/2018
Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs
Presentation
08/21/2018
A Comparison of Drug Utilization Metrics for Two Drug Classes with Nationally Projected Sales and Patient-level Data from the Sentinel Database
Presentation
08/21/2018
Minor Differences, Major Consequences? Lessons Learned from Replication of a Claims-Based Drug Safety Assessment
Presentation
08/21/2018
Use of Multiple Sclerosis Drugs Among Live Birth Pregnancies in the United States
Presentation
08/21/2018
Signal Detection using TreeScan with Drug Classes: Pilot Projects in Sentinel
Presentation
08/21/2018
A New Analytic Tool Developed in the Sentinel System to Assess Adherence To FDA’s Safe Use Recommendations
Presentation
08/20/2018
Estimating “Optimal” Durations for Initial Opioid Analgesic Prescription Following Common Surgical Procedures
Presentation
08/20/2018
Data-Mining for Adverse Events Using the Self-Controlled Tree-Temporal Scan Statistic
Presentation
08/20/2018
Validation of the Combined Comorbidity Score in the ICD-10 Era: Application to High-Risk Populations
Presentation
08/20/2018
Performance of a Distributed Regression Analysis Software and Workflow
Presentation
08/20/2018
Sequential and SequentialDesign: Tools For Prospective Sequential Medical Product Safety Surveillance
Presentation
08/20/2018
Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes Of Interest – An Empirical Evaluation
Presentation
08/20/2018
Long Live the "Medical Data Janitors": International Data Quality Assurance Practices in Distributed Data Network
Presentation
08/20/2018
Advances in the Study of Medication Errors in Computerized Healthcare Databases and Spontaneous Reporting Systems in Europe and North America
Presentation
08/20/2018
Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA's Sentinel System
Presentation
08/20/2018
Developing the Infrastructure to Assess Pregnancy Outcomes Following Vaccination: Influenza Vaccines and Spontaneous Abortion as a Use Case
Presentation
08/20/2018
Diagnostic Algorithms for Identification of Cardiovascular Death in Administrative Claims Databases: A Systematic Review
Presentation
08/20/2018
Computational Algorithms for Distributed Regression Analysis Based on SAS Software
Presentation
08/20/2018
Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs
Publication
08/17/2018
Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study
Publication
08/10/2018
Data Enclaves for Sharing Information Derived From Clinical and Administrative Data
Publication
08/06/2018
Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic
Publication
08/01/2018
Outpatient Influenza Antivirals in a Distributed Data Network for Influenza Surveillance
Publication
07/27/2018
Assessing the Impact of the New ICD‐10‐CM Coding System on Pharmacoepidemiologic Studies — An Application to the Known Association Between Angiotensin‐Converting Enzyme Inhibitors and Angioedema
Publication
06/26/2018
Early Impact of the ICD‐10‐CM Transition on Selected Health Outcomes in 13 Electronic Health Care Databases in the United States
Publication
06/26/2018
Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes of Interest- An Empirical Evaluation
Publication
06/26/2018
Diagnosis‐Based Cohort Augmentation using Laboratory Results Data: The Case of Chronic Kidney Disease
Publication
06/22/2018
A Query Workflow Design to Perform Automatable Distributed Regression Analysis in Large Distributed Data Networks
Publication
05/25/2018
Small Changes, Big Differences? Cohort Variation by Parameter Specifications in Claims-Based Drug Use Evaluations
Presentation
05/21/2018
Relative Performance of Propensity Score Matching Strategies for Subgroup Analyses
Publication
03/15/2018
Evaluation of the US Food and Drug Administration Sentinel Analysis Tools in Confirming Previously Observed Drug-Outcome Associations: The Case of Clindamycin and Clostridium difficile Infection
Publication
03/13/2018
Utilization of Drugs with Pregnancy Exposure Registries During Pregnancy
Publication
03/08/2018
Sequential Surveillance for Drug Safety in a Regulatory Environment
Publication
03/05/2018
Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System
Publication
02/23/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Venous Thromboembolism among Intravenous Immune Globulin Users in the Sentinel Distributed Database
Publication
02/23/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Acute Myocardial Infarction (AMI) Among Intravenous Immune Globulin (IGIV) Users in the Sentinel Distributed Database
Publication
02/15/2018
Butterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal Inference
Presentation
01/12/2018
Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Publication
01/10/2018
Methods for Examining Data Quality in Healthcare Integrated Data Repositories
Presentation
01/03/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database
Publication
12/01/2017
Opioid Tolerance and Urine Drug Testing among Initiates of Extended-Release or Long-Acting Opioids in Food and Drug Administration's Sentinel System
Publication
11/20/2017
Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study
Publication
11/14/2017
Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System
Publication
11/06/2017
Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study
Publication
11/01/2017
Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network
Publication
10/06/2017
A Review of the Performance of Different Methods for Propensity Score Matched Subgroup Analyses and a Summary of their Application in Peer-Reviewed Research Studies
Publication
10/06/2017
Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia (Video Abstract)
Presentation
10/06/2017
The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011
Publication
09/14/2017
Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies
Publication
08/29/2017
Promises and Challenges of Screening for Adverse Events in Sentinel
Presentation
08/27/2017
Impact of ICD-10-CM Transition on Selected Cardiovascular-Related Events in the Sentinel System
Presentation
08/25/2017
TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance
Presentation
08/25/2017
A Review of Methods for Propensity Score Matched Subgroup Analysis and Their Application in Peer Reviewed Research Studies
Presentation
08/25/2017
Identification of Name Confusion Medication Errors in the US FDA's Sentinel System
Presentation
08/25/2017
Early Post-Approval Surveillance of New Molecular Entity Uptake in the Sentinel Distributed Database
Presentation
08/25/2017
Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database
Presentation
08/25/2017
Evaluation of Test Data in Distributed Research Networks: A Sentinel System Example
Presentation
08/25/2017
Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System
Presentation
08/25/2017
Dispensings of Influenza Antiviral Medications in the Sentinel System as a Source of Data for Influenza Surveillance
Presentation
08/25/2017
Curating Inpatient Medication Use Data from a Hospital Network Electronic Medication Administration Record (eMAR) System: Lessons from the Sentinel System About Expanding Drug Safety Surveillance Potential
Presentation
08/25/2017
Distributed Regression Analysis in a Distributed Health Data Network
Presentation
08/25/2017
Listening to Patient Voices in Pharmacoepidemiological Research - Opportunities for Innovation and Inclusion
Presentation
08/25/2017
Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Presentation
08/25/2017
Developing a Mother-Infant Cohort in Sentinel's PRISM Program as a Resource to Monitor the Safety of Vaccine Use During Pregnancy
Presentation
08/25/2017
Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year
Presentation
08/25/2017
Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database
Presentation
08/25/2017
Protocol-Based Assessment of Thromboembolic Events (TEEs) after Intravenous Immune Globulin (IVIg) in the Sentinel Distributed Database (2006-2012)
Presentation
08/25/2017
Expansion of the US FDA's Sentinel System to Inpatient Blood Transfusion Data from Hospital Corporation of America: New Surveillance Options
Presentation
08/25/2017
Evaluation of Case-Finding Algorithm for Venous Thromboembolism Outcome
Presentation
08/25/2017
Opportunities for Rapid Monitoring of New Cancer Treatments: Tyrosine Kinase Inhibitors in the Sentinel Distributed Database
Presentation
08/25/2017
Using the Self-Controlled Risk Interval (SCRI) Method to Study Vaccine Safety
Presentation
08/25/2017
Assessment of Transfusion-Related Acute Lung Injury After Red Blood Cell, Plasma and Platelet Administration: Initial Results in the Sentinel System
Presentation
08/25/2017
Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth
Presentation
08/25/2017
Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System
Presentation
08/25/2017
Developing a Mobile App for Studies of Medication Safety
Presentation
08/24/2017
Randomized Clinical Trial Using FDA's Sentinel Infrastructure: An Analysis Assessing Feasibility
Presentation
08/24/2017
Medical Product and Performance Evaluation Programs Using Distributed Data Sources
Presentation
08/24/2017
Type 1 and Type 2 Diabetes Mellitus Identification Using ICD-9-CM Codes Within a Cohort of New Users of Drugs Labeled for Type 2 Diabetes Mellitus
Presentation
08/23/2017
Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners
Publication
08/10/2017
Sentinel Modular Program for Propensity-Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia
Publication
07/04/2017
Statistical Power for Postlicensure Medical Product Safety Data-Mining
Publication
06/12/2017
Antiemetic Use Among Pregnant Women in the United States: The Escalating Use of Ondansetron
Publication
02/20/2017
Missing Laboratory Results Data in Electronic Health Databases: Implications for Monitoring Diabetes Risk
Publication
01/06/2017
Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making
Publication
12/01/2016
Distributed Data Networks: A Blueprint for Big Data Sharing and Healthcare Analytics
Publication
11/18/2016
The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies
Publication
11/14/2016
A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data
Publication
09/06/2016
Pilot Test of the Sentinel Modular Program for Propensity Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Severe Hypoglycemia
Presentation
08/24/2016
Monitoring All Drugs for a Specific Outcome in the Sentinel System
Presentation
08/23/2016
Assessing Quadrivalent HPV Vaccine Safety using the Self-Controlled Tree-Temporal Scan Statistic
Presentation
08/23/2016
A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems
Presentation
08/23/2016
Utilization of Laboratory Results Data to Enhance Pregnancy Cohort Identification in a Distributed Data Network
Presentation
08/23/2016
Do Hemoglobin Lab Test Results Increase Detection of Upper Gastrointestinal Bleeding (UGIB)?
Presentation
08/23/2016
Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA's Sentinel Program
Presentation
08/23/2016
A Framework for Rapid Medical Product Safety Assessment: FDA's Sentinel Toolkit
Presentation
08/23/2016
ICD-10-CM: Is Sentinel Ready?
Presentation
08/23/2016
Assessment of the US Food and Drug Administration’s Sentinel Analysis Tools: Angiotensin-Converting Enzyme Inhibitors and Angioedema
Presentation
08/23/2016
Ondasetron Use Among Pregnancies Identified in the Sentinel Distributed Database
Presentation
08/23/2016
Utilization Patterns for Products with Pregnancy Exposure Registries in Pregnant Versus Non-Pregnant Women in the Sentinel Database
Presentation
08/23/2016
Diagnosis-Based Cohort Augmentation Using Laboratory (Lab) Data in the FDA Sentinel Initiative: The Case of Chronic Kidney Disease (CKD)
Presentation
08/23/2016
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association
Publication
08/22/2016
Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association
Publication
07/14/2016
Quantitative Bias Analysis in Regulatory Settings
Publication
06/10/2016
Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study
Publication
06/07/2016
Evidence Generation from Healthcare Databases: Recommendations for Managing Change
Publication
05/17/2016
Use of Selective Serotonin Reuptake Inhibitors (SSRIs) in Women Delivering Liveborn Infants and other Women of Child-Bearing Age within the U.S. Food and Drug Administration's Mini-Sentinel Program
Publication
05/13/2016
Methods for using Clinical Laboratory Test Results as Baseline Confounders in Multi-Site Observational Database Studies when Missing Data are Expected
Publication
05/04/2016
Uptake of New Drugs in the Early Post-Approval Period in the Mini-Sentinel Distributed Database
Publication
05/04/2016
Prospective Influenza Vaccine Safety Surveillance Using Fresh Data in the Sentinel System
Publication
04/30/2016
Intravenous Immune Globulin and Thromboembolic Adverse Events: A Systematic Review and Meta-Analysis of RCTs
Publication
04/24/2016
Changing Patterns of Asthma Medication use Related to U.S. Food and Drug Administration Long-Acting Beta2-agonist Regulation from 2005-2011
Publication
03/01/2016
Evaluation of Propensity Scores, Disease Risk Scores, and Regression in Confounder Adjustment for the Safety of Emerging Treatment with Group Sequential Monitoring
Publication
02/15/2016
Data Extraction and Management in Networks of Observational Health Care Databases for Scientific Research: A Comparison of EU-ADR, OMOP, Mini-Sentinel and MATRICE Strategies
Publication
02/08/2016
The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance
Publication
01/12/2016
Evaluation of the Risk of Venous Thromboembolism after Quadrivalent Human Papillomavirus Vaccination among U.S. Females
Publication
01/02/2016
Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011
Publication
01/02/2016
Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance
Publication
01/01/2016
Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program
Publication
12/08/2015
Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine
Publication
09/14/2015
Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin
Publication
07/14/2015
Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance
Publication
05/22/2015
A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program
Publication
03/13/2015
Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study
Publication
12/22/2014
Adherence to Guidelines for Glucose Assessment in Starting Second-Generation Antipsychotics
Publication
10/06/2014
Characteristics of Study Design and Elements that may Contribute to the Success of Electronic Safety Monitoring Systems
Publication
09/28/2014
Four Health Data Networks Illustrate The Potential For A Shared National Multipurpose Big-Data Network
Publication
07/01/2014
Electronic Clinical Laboratory Test Results Data Tables: Lessons from Mini-Sentinel
Publication
02/18/2014
Intussusception Risk after Rotavirus Vaccination in U.S. Infants
Publication
02/06/2014
Framework for Assessment of Positive Results from Signal Refinement
Publication
01/01/2014
A Systematic Review of Validated Methods for Identifying Systemic Lupus Erythematosus (SLE) using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods to Capture Stillbirth and Spontaneous Abortion using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods for Identifying Transverse Myelitis using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods for Identifying Uveitis using Administrative or Claims Data
Publication
12/30/2013
Postlicensure Rapid Immunization Safety Monitoring Program (PRISM) Data Characterization
Publication
12/30/2013
PRISM Supplement to Vaccine - Active Surveillance of Vaccine Safety in the US Food and Drug Administration’s Mini-Sentinel Program: Identification of Exposures and Outcomes
Publication
12/30/2013
Methods for Systematic Reviews of Administrative Database Studies Capturing Health Outcomes of Interest
Publication
12/30/2013
A Systematic Review of Validated Methods for Identifying Bell's Palsy using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods to Capture Acute Bronchospasm using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods to Capture Several Rare Conditions using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods for Identifying Kawasaki Disease using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods to Capture Myopericarditis using Administrative or Claims Data
Publication
12/30/2013
A Systematic Review of Validated Methods for Identifying Patients with Rheumatoid Arthritis using Administrative or Claims Data
Publication
12/30/2013
Validation of Anaphylaxis in the Food and Drug Administration's Mini-Sentinel
Publication
09/05/2013
Self-Control Tree Scan Data Mining for Vaccine Adverse Events
Presentation
08/27/2013
Re-Using Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals via Modular Analytic Programs
Publication
08/07/2013
Multivariable Confounding Adjustment in Distributed Data Networks without Sharing of Patient-Level Data
Publication
07/22/2013
A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions
Publication
07/12/2013
Validity of Diagnostic Codes to Identify Cases of Severe Acute Liver Injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database
Publication
06/25/2013
Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program
Publication
05/13/2013
Investments in Infrastructure for Diverse Research Resources and the Health of the Public
Publication
05/08/2013
Is Size the Next Big Thing in Epidemiology?
Publication
05/01/2013
Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding
Publication
04/04/2013
Comparative Risk for Angioedema Associated with the Use of Drugs that Target the Renin-Angiotensin-Aldosterone System
Publication
11/12/2012
Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance
Publication
11/01/2012
Validation of Acute Myocardial Infarction in the Food and Drug Administration's Mini-Sentinel Program
Publication
06/29/2012
Health Outcomes of Interest for Evaluation in the Postlicensure Rapid Immunization Safety Monitoring Program
Publication
04/16/2012
Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative Data: Summary of Findings and Suggestions for Future Research
Publication
02/05/2012
PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program
Publication
01/31/2012
Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Transfusion-Related ABO Incompatibility Reactions using Administrative and Claims Data
Publication
01/19/2012
Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Erythema Multiforme Major/Minor/Not otherwise specified, Stevens–Johnson Syndrome, or Toxic Epidermal Necrolysis using Administrative and Claims Data
Publication
01/19/2012
Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons Learned
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Anaphylaxis, Including Anaphylactic Shock and Angioneurotic Edema, using Administrative and Claims Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Hypersensitivity Reactions other than Anaphylaxis (Fever, Rash, and Lymphadenopathy), using Administrative and Claims Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack using Administrative Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Pulmonary Fibrosis and Interstitial Lung Disease using Administrative and Claims Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Heart Failure using Administrative Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Acute Respiratory Failure using Administrative and Claims Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Atrial Fibrillation using Administrative Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Orthopedic Implant Removal and Revision using Administrative Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Ventricular Arrhythmias using Administrative and Claims Data
Publication
01/19/2012
Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel
Publication
01/19/2012
The U.S. Food and Drug Administration's Mini-Sentinel Program: Status and Direction
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Venous Thromboembolism using Administrative and Claims Data
Publication
01/19/2012
A Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical Agent
Publication
01/19/2012
The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product Safety
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Depression using Administrative Data
Publication
01/19/2012
The Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise
Publication
01/19/2012
The Organizational Structure and Governing Principles of the Food and Drug Administration's Mini-Sentinel Pilot Program
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Suicide or Suicidal Ideation using Administrative or Claims Data
Publication
01/19/2012
A Policy Framework for Public Health uses of Electronic Health Data
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Seizures, Convulsions, or Epilepsy using Administrative and Claims Data
Publication
01/19/2012
Design Considerations, Architecture, and Use of the Mini-Sentinel Distributed Data System
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Pancreatitis using Administrative Data
Publication
01/19/2012
Design Considerations in an Active Medical Product Safety Monitoring System
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Lymphoma using Administrative Data
Publication
01/19/2012
Using High-Dimensional Propensity Scores to Automate Confounding Control in a Distributed Medical Product Safety Surveillance System
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims Data
Publication
01/19/2012
When Should Case-Only Designs be used for Safety Monitoring of Medical Products?
Publication
01/19/2012
A Systematic Review of Validated Methods for Identifying Infection Related to Blood Products, Tissue Grafts, or Organ Transplants using Administrative Data
Publication
01/19/2012
Effects of Adjusting for Instrumental Variables on Bias and Precision of Effect Estimates
Publication
06/08/2011
Developing the Sentinel System — A National Resource for Evidence Development
Publication
02/10/2011