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Methods

Stages of Methods Projects

Sentinel develops a wide range of methods to enhance medical product safety assessment.

Early Stage Methods Projects

Early stage methods projects represent truly novel ideas and innovations. They require completion of proof-of-concept work.

Mid-Stage Methods Projects

Mid-stage methods projects focus on methodological techniques showing statistical or epidemiological value. But, they have not been fully applied in the Sentinel Common Data Model (SCDM).

Later Stage Methods Projects

Later stage methods projects create a prototype to inform production-ready analytic tools.

Interested in learning more about methods? Below is a full list of Sentinel's methods.

Search Methods Projects

Title Status Date
Maintaining and Expanding the Reach of the Sentinel EHR and Claims Network (DI8) In progress
Empirical Application of the Sentinel EHR and Claims Data Partner Network to Enhance ARIA Sufficient Inferential Requests and Atypical Descriptive Requests (Use Case Package 2) In progress
Incorporate a Range of Frequently Used Engineering Features from EHRs into the Sentinel Common Data Model in the Sentinel EHR and Claims Linked Data Partner Network In progress
COVID-19 Pandemic Related Changes in Healthcare Utilization Among Insured Persons in the US and its Impact on Pharmacoepidemiologic Research Complete
Development and Refinement of a Toolkit for Large Scale Covariate Adjustment in the Electronic Health Record and Claims Data Partner Network In progress
Empirical Application of the Sentinel Electronic Health Record (EHR) and Claims Data Partner Network to Address ARIA Insufficient Inferential Requests In progress
Monitoring of Safety and Effectiveness of COVID-19 Therapeutics: Aim 1 Protocol Development Complete
Characterization of COVID-19 Vaccination Data in the SDD In progress
Characterization of COVID-19 Genomic Data in Sentinel Distributed Database Complete
Effectiveness of Fixed Triple Combination Inhaled Corticosteroid (ICS), Long-Acting Beta-Agonist (LABA), and Long-Acting Muscarinic Antagonist (LAMA) Products vs. Multiple Inhaler ICS, LABA, LAMA Therapy in Patients With COPD Protocol in preparation
Data Expansion Implementation: Linking the National Death Index (NDI) data to the Sentinel Distributed Database (SDD) In progress
Subset Calibration Methods In progress
Creating a Sentinel Linked Electronic Health Record (EHR)-claims Development Network In progress
Medical Literature and Data on Cannabis Use Complete
Development and Evaluation of Electronic Health Record (EHR) Information Extraction Pipeline and Tree-Based Scan Statistic (TBSS) Methods for EHR-Based Signal Detection (DA2) In progress
Inclusion of Semi-Structured and Unstructured Electronic Health Record (EHR) Data in Confounding Adjustment and Outcome Ascertainment In progress
Onboarding of Commercial Electronic Health Record (EHR) Data Partners In progress
Data Sandbox and Engagement Environment Discovery Project Complete
Approaches to Handling Partially Observed Confounder Data From Electronic Health Records (EHR) In Non-randomized Studies of Medication Outcomes Protocol in preparation
Augmenting Date of Death & Cause of Death Ascertainment in Sentinel In progress
Sentinel Innovation Center Request for Proposal: Feature Engineering Complete
Improving Capture of Race and Ethnicity Data in Sentinel Complete
Development and Illustration of a Framework for Conducting Nonrandomized Studies of Medication Safety and Effectiveness Using Healthcare Databases In progress
Identification and Mitigation of Structured Electronic Health Record (EHR) Source Data Mapping Issues Complete
Evaluation of Existing Approaches to EHR-based Signal Identification Complete
Making Medicaid Data More Accessible Through Common Data Models and FHIR APIs In progress
Longitudinal Trends in Incident and Prevalent use of Long-Acting Beta-2 Agonists: An Interrupted Time Series Analysis Complete
Develop a Common Protocol for Data Quality Metrics in Electronic Health Records Complete
Using Unsupervised Learning to Harmonize Data Across Data Systems In progress
TreeScan in Pregnancy In progress
Representation of Unstructured Data Across Common Data Models Complete
Improving Probabilistic Phenotyping of Incident Outcomes through Enhanced Ascertainment with Natural Language Processing In progress
Demographic Characteristics and Length of Enrollment of the Individuals Enrolled over Time in the Sentinel Distributed Database Complete
Extending Machine Learning Methods Development in Sentinel: Follow-up Analyses for Anaphylaxis Algorithm and Formalization of a General Phenotyping Framework (Phase 3) In progress
Advancing Scalable Natural Language Processing Approaches for Unstructured Electronic Health Record Data Complete
COVID-19 Pregnancy Study Implementation In progress
Incidence of Latent Tuberculosis Infection: A Descriptive Analysis Complete
A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy Complete
Assessment of the Natural History of Coagulopathy in COVID-19 Complete
Master Protocol Development: COVID-19 Natural History Complete
Addition of COVID Laboratory Results Data to the Sentinel Common Data Model (SCDM) and Establishment of a “Freshest Feasible” Rapid COVID-19 Data Resource In progress
Sequential TreeScan Methods Development Complete
Quantitative Assessment of the Impact of Nitrosamine Contamination and Angiotensin Receptor Blockers (ARB) Recall on ARB Utilization: A Multinational Study Complete
Pilot Test of Vital Signs and Laboratory Results Table Descriptive Modules in the Sentinel Distributed Database Complete
Enhancing Causal Inference in the Sentinel System: An Evaluation of Targeted Learning and Propensity Scores for Confounding Control in Drug Safety In progress
HCA COVID-19 Activities: Monitoring of Critical Drugs and Assessment of Natural History of Disease In progress
TriNetX Rapid Querying In progress
Validation of Hospitalized COVID-19 Detected from Claims-Based Algorithms Complete
Assessing Sentinel System Capability to Collect and Analyze Medical Countermeasure Data for the FDA Office of Counterterrorism and Emerging Threats (OCET) Complete
Near Real-Time Monitoring of Critical Drugs for the Care of Patients with COVID-19 In progress
Horizon Scan of Electronic Health Record Databases Complete
Effects of Medical Products on Suicidal Ideation and Behavior Complete
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery Complete
Application of TreeScan Data Mining Method to HPV9 (Gardasil 9) Vaccine Complete
ARIA Tool Enhancement: Integrating TreeScan Signal Identification Capabilities Complete
Evaluation of Propensity Score Based Methods in Sentinel Study Settings Using Simulation Experiments Complete
Development and Evaluation of a Global Propensity Score for Data Mining with Tree-Based Scan Statistics Complete
Development of a Chart Validation Table In progress
Validation of Acute Pancreatitis Using Machine Learning and Multi-Site Adaptation for Anaphylaxis Complete
Investigation of Nonproprietary Name Suffix Use for Biologics and Biosimilars In progress
Characteristics of Patients Using Anti-Diabetic Agents in the Patient-Centered Clinical Research Network (PCORnet): An Exploratory Query of a Network of Electronic Health Records Complete
Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control Complete
Distributed Regression Analysis: Utilizing Data from Various Data Partners in a Distributed Manner Complete
ARIA Tool Enhancement: Enabling Interrupted Time Series Analyses Complete
Machine Learning Pilot for Electronic Phenotyping of Health Outcomes of Interest Complete
Data Infrastructure Expansion: Developing a Mother-Infant Linkage Table in the Sentinel Common Data Model (SCDM) Complete
Validation of Anaphylaxis Using Machine Learning In progress
Cross-Network Directory Service Complete
Standardization and Querying of Data Quality Metrics and Characteristics for Electronic Health Data Complete
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel Complete
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete
Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET) Complete
Functional Specifications for Propensity Score Table 1 Complete
Disease Risk Score Exploratory Methods Complete
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative Complete
Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program Complete
Sentinel Medical Chart Review Gap Analysis Complete
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins Complete
Optimal Propensity Score Matching Strategies for Subgroup Analyses Complete
Mini-Sentinel: Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data Complete
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case Complete
Sequential Surveillance for Drug Safety in a Regulatory Environment Complete
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins Complete
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case Complete
Conversion of Medicare Claims Synthetic Public Use Files (SynPUFs) to Sentinel Common Data Model (SCDM) Format Complete
Methotrexate Medication Errors Complete
TreeScan Extension (PRISM) Complete
Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database (MSDD) Complete
Inverse Probability of Treatment Weighting Functional Specifications and Prototype Development In progress
Evaluating Variability with 1:1 Propensity Score-Matched Analyses Complete
The Use of Propensity Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring Complete
Death Data Exploration Complete
Evaluation of New Technologies Associated with Chart Review Complete
Quantitative Bias Analysis Methodology Development Complete
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide Complete
TreeScan with Propensity Scores Complete
TreeScan for Drugs Complete
Developing Disease Risk Score Estimation Functional Specification In progress
Identification of Pregnant Women in the Sentinel Distributed Database and Determination of Drug Use Among Pregnant and Non-Pregnant Women – ICD-10-CM Pregnancy Tool Algorithm Update Complete
Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema Complete
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete
TreeScan Power (PRISM) Complete
Mini-Sentinel: Analytic Methods for Using Laboratory Test Results in Active Database Surveillance Complete
Outcome-Based TreeScan Analyses (DrugSCAN) Complete
Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA’s Sentinel Program Complete
Mini-Sentinel: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angiotensin-Converting Enzyme (ACE) Inhibitors Versus Beta-blockers Complete
Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel Complete
Mini-Sentinel: Two-Dimensional Scan Statistics for Assessing Vaccine Safety in Pregnancy (PRISM) Complete
Mini-Sentinel: Routine Prospective Safety Surveillance for New Drugs, Vaccines, and Other Biologic Products Complete
Validating Type 1 and Type 2 Diabetes Mellitus in the Mini-Sentinel Distributed Database using the Surveillance PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) DataLink Complete
Mini-Sentinel: Quantifying the Impact of Time-Varying Baseline Risk Adjustment in the Self-Controlled Risk Interval Design (PRISM) Complete
Mini-Sentinel: Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database Complete
Mini-Sentinel: Analytical Methods to Assess Robustness of Drug Safety Monitoring Results Complete
Decision Analysis for Surveillance and Health - Pandemic Influenza (PRISM) Complete
Mini-Sentinel: 15 Cohorts of Interest for Surveillance Preparedness Complete
Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database Complete
Mini-Sentinel: Statistical Methods for Improving Confounder Adjustment For Emergent Treatment Comparison Complete
Mini-Sentinel: Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Complete
Demonstrate Feasibility of New Mini-Sentinel Group Sequential Monitoring Methods in a Distributed Setting by Implementing Them in Practice Complete
Mini-Sentinel: Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities Complete
Mini-Sentinel: Vaccine Safety Monitoring - Data Characterization Complete
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 3 Complete
Mini-Sentinel: Developing, Implementing, and Testing a Program for High-Dimensional Propensity Score Adjustment in the Mini-Sentinel Distributed Data Environment Complete
Vaccine Safety Monitoring - Adverse Events Complete
Mini-Sentinel: Framework for Assessment of Signal Refinement Positive Results Complete
Mini-Sentinel: Methods to Evaluate Impact of FDA Regulatory Actions Complete
Mini-Sentinel: Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete
Mini-Sentinel: Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 2 Complete
Mini-Sentinel: Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete
Mini-Sentinel: Case-Based Methods Complete
Mini-Sentinel: Signal Evaluation Methods (Automated) Complete
Mini-Sentinel: Sequential Testing Methods Complete
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 1 Complete