Statistical approaches to detecting unexpected medical product safety concerns have been used for decades with spontaneous reporting data. New quantitative approaches designed for longitudinal data, particularly the Tree-Based Scan Statistic (TreeScan), have been developed in Sentinel. Many projects have been initiated to develop, test, and evaluate these methods. Project results can be found in the trainings, presentations and publications listed below.
Additional programming code and technical documentation are also provided for investigators below.
Public Trainings
- 2023 Sentinel Public Training Day: First Trimester Exposure to Fluoroquinolones: A Case Study in Signal Identification
- 2022 14th Annual Sentinel Public Workshop: Updates on Signal Identification in the Sentinel System
- 2020 Sentinel Public Training on Maternal Health and Pregnancy: Overview of Sentinel Tool Capabilities, Mother-Infant Linkage and Pregnancy Analyses
- 2019 10th Biennial Conference on Signal Detection and Signal Management in Pharmacovigilance: Signal Identification Methods in the Sentinel System
- 2018 10th Annual Sentinel Initiative Public Workshop, Day 2 Training
- 2018 Duke Margolis Public Meeting: Implementation of Signal Detection Capabilities in the Sentinel System
To browse the full list of past and upcoming Sentinel Initiative training events, visit the Meetings Workshops, & Trainings page.
ICPE Presentations
- 2019 A General Propensity Score for Signal Detection using Tree-Based Scan Statistics
- 2018 Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic
- 2018 Signal Detection using TreeScan with Drug Classes: Pilot Projects in Sentinel
- 2017 TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance
- 2017 Promises and Challenges of Screening for Adverse Events in Sentinel
Projects and Publications
- Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery (February 2020)
- Identifying Signals of Interest When Screening for Drug-Outcome Associations in Health Care Data (September 2018)
- Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic (August 2018)
- Hypothesis-Free Screening of Large Administrative Databases for Unsuspected Drug-Outcome Associations (June 2018)
- Sequence Symmetry Analysis in Pharmacovigilance and Pharmacoepidemiologic Studies (July 2017)
- Statistical Power for Postlicensure Medical Product Safety Data-Mining (June 2017)
- Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel (July 2016)
- Structured Assessment for Prospective Identification of Safety Signals in Electronic Medical Records: Evaluation in The Health Improvement Network (December 2014)
- Drug Adverse Event Detection in Health Plan Data Using the Gamma Poisson Shrinker and Comparison to the Tree-based Scan Statistic (March 2014)
- Empirical Performance of The Calibrated Self-Controlled Cohort Analysis Within Temporal Pattern Discovery: Lessons for Developing A Risk Identification and Analysis System (October 2013)
- Shrinkage Observed-To-Expected Ratios for Robust and Transparent Large-Scale Pattern Discovery (February 2012)
- The U.S. Food and Drugs Administration’s Sentinel Initiative: Expanding the Horizons of Medical Product Safety (January 2012)
- Evidence of Depression Provoked by Cardiovascular Medication: A Prescription Sequence Symmetry Analysis (September 1996)
Technical Resources for Investigators
- TreeScan: Software for the Tree-Based Scan Statistic
- TreeScan Software
- Technical Documentation
- TreeExtraction Documentation
- TreeExtraction Program
- SAS Package Toolkits
- Supporting Tree Mapping Files
Want a complete list of activities? Visit the Signal Identification Projects page.