Publications and 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 conference materials.

Titlesort descending Authors Date Posted
2013 ICPE Presentation: Self-Control Tree Scan Data Mining for Vaccine Adverse Events

Martin Kulldorf, Carolyn Balsbaugh, Inna Dashevsky, Ruth Gil-Prieto, Grace Lee, Michael Nguyen, David Martin, Estelle Russek-Cohen, Robert Ball, Robert Davis

08/28/2013
2016 ICPE Poster: A Framework for Rapid Medical Product Safety Assessment: FDA's Sentinel Toolkit

Elizabeth Cavagnaro, Hannah Katcoff, Candace Fuller, Jennifer R. Popovic, Tiffany S. Woodworth, Nicolas Beaulieu, April Duddy, Eric Gravel, Erick Moyneur, Sengwee Toh, Jeffrey Brown

08/25/2016
2016 ICPE Poster: A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems

Steven T. Bird, Kate Gelperin, Lockwod Taylor, Leyla Sahin, Mohamed Mohamoud, Christian Hampp

08/25/2016
2016 ICPE Poster: Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA's Sentinel Program

John G. Connolly, Joshua J. Gagne

08/25/2016
2016 ICPE Poster: Do Hemoglobin Lab Test Results Increase Detection of Upper Gastrointestinal Bleeding (UGIB)?

Elisabetta Patorno, Joshua J. Gagne, Christine Y. Lu, Kevin Haynes, Andrew T. Sterrett, Jason Roy, Xingmei Wang, Marsha A. Raebel

08/25/2016
2016 ICPE Poster: Pilot Test of the Sentinel Modular Program for Propensity Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Severe Hypoglycemia

Meijia Zhou, Shirley V. Wang, Charles E. Leonard, Joshua J. Gagne, Candace Fuller, Christian Hampp, Patrick Archdeacon, Sengwee Toh, Aarthi Iyer, Tiffany Siu Woodworth, Elizabeth Cavagnaro, Catherine A. Panozzo, Sophia Axtman, Ryan M. Carnahan, Elizabeth A. Chrischilles, Sean Hennessey

08/26/2016
2016 ICPE Poster: Utilization of Laboratory Results Data to Enhance Pregnancy Cohort Identification in a Distributed Data Network

Kevin Haynes, Andrew Sterrett, Susan M. Shetterly, Mano S. Selvan, Joshua J. Gagne, Christine Y. Lu, Azadeh Shoaibi, Marsha A. Raebel

08/25/2016
2016 ICPE Presentation: Assessing Quadrivalent HPV Vaccine Safety using the Self-Controlled Tree-Temporal Scan Statistic

Martin Kulldorff, Katherine Yih

08/25/2016
2016 ICPE Presentation: Assessment of the US Food and Drug Administration’s Sentinel Analysis Tools: Angiotensin-Converting Enzyme Inhibitors and Angioedema

Joshua Gagne

08/25/2016
2016 ICPE Presentation: Diagnosis-Based Cohort Augmentation Using Laboratory (Lab) Data in the FDA Sentinel Initiative: The Case of Chronic Kidney Disease (CKD)

David H. Smith

08/25/2016
2016 ICPE Presentation: Monitoring All Drugs for a Specific Outcome in the Sentinel System

Judith C. Maro, Gerald Dal Pan, Jeffrey S. Brown, Inna Dashevsky, Martin Kulldorff

08/25/2016
2016 ICPE Presentation: Ondasetron Use Among Pregnancies Identified in the Sentinel Distributed Database

Lockwood G. Taylor

08/25/2016
2016 ICPE Presentation: Utilization Patterns for Products with Pregnancy Exposure Registries in Pregnant Versus Non-Pregnant Women in the Sentinel Database

Steven T. Bird, Lockwood Taylor, Christian Hampp, Kate Gelperin, Darren Toh, Susan Andrade, Katie Haffenreffer, Marsha Reichman, Leyla Sahin

08/25/2016
2016 ICPE Symposium: ICD-10-CM: Is Sentinel Ready?

Darren Toh

08/25/2016
2017 ICPE Presentation: Protocol-Based Assessment of Thromboembolic Events (TEEs) after Intravenous Immune Globulin (IVIg) in the Sentinel Distributed Database (2006-2012)

Eric Ammann PhD, University of Iowa, College of Public Health, Iowa City, IA

08/26/2017
2017 ICPE Plenary: Medical Product and Performance Evaluation Programs Using Distributed Data Sources

Richard Platt MD, MS, Harvard Pilgrim Health Care Institute and Harvard Medical School 

Robert Ball, MD, MPH, Office of Surveillance and Epidemiology, CDER

08/25/2017
2017 ICPE Poster: A Review of Methods for Propensity Score Matched Subgroup Analysis and Their Application in Peer Reviewed Research Studies

Shirley Wang, PhD, ScM, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

08/26/2017
2017 ICPE Poster: Dispensings of Influenza Antiviral Medications in the Sentinel System as a Source of Data for Influenza Surveillance

Noelle Cocoros, DSc, MPH, Harvard Pilgrim Health Care Institute, Boston MA

08/26/2017
2017 ICPE Poster: Distributed Regression Analysis in a Distributed Health Data Network

Jessica M. Malenfant, MPH, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

08/26/2017
2017 ICPE Poster: Early Post-Approval Surveillance of New Molecular Entity Uptake in the Sentinel Distributed Database

Nicole R. Haug, MPH, Dept. of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, MA

08/26/2017
2017 ICPE Poster: Evaluation of Case-Finding Algorithm for Venous Thromboembolism Outcome

Megan Reidy, Jill L.O. de Jong, Lauren Zichittella, W. Katherine Yih

08/26/2017
2017 ICPE Poster: Evaluation of Test Data in Distributed Research Networks: A Sentinel System Example

Emily C. Welch

08/26/2017
2017 ICPE Poster: Opportunities for Rapid Monitoring of New Cancer Treatments: Tyrosine Kinase Inhibitors in the Sentinel Distributed Database

Anita K. Wagner, PharmD, MPH, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

08/26/2017
2017 ICPE Poster: Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System

Genna Panucci

08/26/2017
2017 ICPE Poster: 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

Laura Hou

08/24/2017
2017 ICPE Pre-Conference Course: Using the Self-Controlled Risk Interval (SCRI) Method to Study Vaccine Safety

Katherine Yih

08/26/2017
2017 ICPE Presentation: Impact of ICD-10-CM Transition on Selected Cardiovascular-Related Events in the Sentinel System

Tiffany Siu Woodworth

08/26/2017
2017 ICPE Presentation: Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System

Noelle Cocoros

08/26/2017
2017 ICPE Presentation: 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

Jennifer R. Popovic

08/26/2017
2017 ICPE Presentation: Developing a Mobile App for Studies of Medication Safety

Sascha Dublin

08/25/2017
2017 ICPE Presentation: Developing a Mother-Infant Cohort in Sentinel's PRISM Program as a Resource to Monitor the Safety of Vaccine Use During Pregnancy

Alison Kawai

08/26/2017
2017 ICPE Presentation: Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database

Richard Scott Swain

08/26/2017
2017 ICPE Presentation: Identification of Name Confusion Medication Errors in the US FDA's Sentinel System

Noelle Cocoros

08/26/2017
2017 ICPE Presentation: Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database

Crystal Garcia

08/26/2017
2017 ICPE Presentation: Promises and Challenges of Screening for Adverse Events in Sentinel

Michael Nguyen

08/28/2017
2017 ICPE Presentation: Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System

Elizabeth Chrischilles

08/26/2017
2017 ICPE Presentation: Randomized Clinical Trial Using FDA's Sentinel Infrastructure: An Analysis Assessing Feasibility

Noelle Cocoros on behalf of Crystal Garcia

08/24/2017
2017 ICPE Presentation: Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth

Efe Eworuke

08/26/2017
2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year

Michael D. Nguyen, Judith C. Maro, Lockwood G. Taylor, David Moeny, Efe Eworuke, Steven Bird

08/25/2017
2017 ICPE Symposium: Listening to Patient Voices in Pharmacoepidemiological Research - Opportunities for Innovation and Inclusion

Wendy Camello Castillo

08/26/2017
2017 ICPE Workshop: TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance

Judith Maro, Rima Izem, Martin Kulldorff, Azadeh Shoaibi

08/26/2017
2018 ICPE Poster: Misclassification of Time-at-Risk Due to Free Drug Sample Use: A Simulation Study

Zilu Zhang, Efe Eworuke, Margie R. Goulding, Michael D. Nguyen, Bruce Fireman, Judith C. Maro

08/24/2018
2018 ICPE Poster: A Comparison of Drug Utilization Metrics for Two Drug Classes with Nationally Projected Sales and Patient-level Data from the Sentinel Database

Mohamed Mohamoud, Yanmin Zhu, Steven Bird, Rima Izem, Nicole R. Haug, Anita Wagner, Judith C. Maro, Efe Eworuke

08/23/2018
2018 ICPE Poster: A New Analytic Tool Developed in the Sentinel System to Assess Adherence To FDA’s Safe Use Recommendations

Noelle Cocoros, Anita Wagner, Andrew Petrone, Elnara Fazio-Eynullayeva, Yulan Ding, Rima Izem, Joo-Yeon Lee, Jacqueline Major, Michael Nguyen, Jing Ju

08/22/2018
2018 ICPE Poster: 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

Catherine A. Panozzo, Emily C. Welch, Tiffany S. Woodworth, Ting-Ying Huang, Qoua L. Her, Joshua J. Gagne, Jenny W. Sun, Catherine Rogers, Talia J. Menzin, Max Ehrmann, Katherine E. Freitas, Nicole R. Haug, Sengwee Toh

08/23/2018
2018 ICPE Poster: Computational Algorithms for Distributed Regression Analysis Based on SAS Software

Qoua Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Sengwee Toh

08/22/2018
2018 ICPE Poster: Developing the Infrastructure to Assess Pregnancy Outcomes Following Vaccination: Influenza Vaccines and Spontaneous Abortion as a Use Case

Alison Tse Kawai, Megan Reidy, Lauren Zichittella, Colleen Stockdale, Erin Longley, Cheryl Walraven, Chunfu Liu, Azadeh Shoaibi, Sandra Feibelmann, Grace Lee

08/22/2018
2018 ICPE Poster: Diagnostic Algorithms for Identification of Cardiovascular Death in Administrative Claims Databases: A Systematic Review

Sonal Singh, Hassan Fouyazi, Kathryn Anzuoni, Leah Goldman, Jea Young Min, Marie Griffin, Carlos G. Grijalva, James A. Morrow, Christine Whitmore, Charles E. Leonard, Mano Selvan, Vinit Nair, Yunping Zhou, Sengwee Toh, Andrew Petrone, James Williams, Elnara Fazio-Eynullayeva, Richard S. Swain, D. Tyler Coyle, Susan Andrade

08/22/2018
2018 ICPE Poster: First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies

Steven Bird, Kate Gelperin, Leyla Sahin, Karen B. Bleich, Elnara Fazio-Eynullayeva, Corinne Woods, Erica Radden, Tamara Johnson, Mayura Shinde, Ira Krefting

08/24/2018
2018 ICPE Poster: Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA's Sentinel System

Marie C. Bradley, Mayura Shinde, Yodit Belew, D. Tyler Coyle, Jason Hickok, Russell Poland, Karla M. Miller, Austin Cosgrove, Crystal Garcia, Rong Tilney, Caren Spencer-Smith, Kimberly Smith, Ronald Holt, Candace Fuller

08/22/2018
2018 ICPE Presentation: Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic

Shirley V. Wang, Judith C. Maro, Elande Baro, Rima Izem, Inna Dashevsky, James R. Rogers, Michael Nguyen, Joshua J. Gagne, Elisabetta Patorno, Krista F. Huybrechts, Jacqueline M Major, Esther Zhou, Megan Reidy, Austin Cosgrove, Sebastian Schneeweiss, Martin Kulldorff

08/24/2018
2018 ICPE Presentation: Data-Mining for Adverse Events Using the Self-Controlled Tree-Temporal Scan Statistic

Katherine Yih

08/22/2018
2018 ICPE Presentation: Early Lessons on ICD-10-CM/PCS Transition in Claims-Based Drug Safety Assessments

Ting‐Ying Huang, Emily C. Welch, Margie Goulding, David J. Graham, Rongmei Zhang, Marie Bradley

08/23/2018
2018 ICPE Presentation: Estimating “Optimal” Durations for Initial Opioid Analgesic Prescription Following Common Surgical Procedures

Mallika L. Mundkur, Tamra Meyer, Talia Menzin, Judy Staffa, Corinne Woods, Judith C. Maro, Justin Bohn

08/22/2018
2018 ICPE Presentation: Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs

Sarah K. Dutcher, Jennifer R. Popovic, Michael Nguyen, Sukhminder K. Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B. Petrone, Anita K. Wagner, Joshua J. Gagne

08/23/2018
2018 ICPE Presentation: Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes Of Interest – An Empirical Evaluation

Rishi J. Desai, Richard Wyss, Yinzhu Jin, Justin Bohn, Sengwee Toh, Austin Cosgrove, Adee Kennedy, Jessica Kim, Clara Kim, Rita Ouellet-Hellstrom, Sara Karami, Jacqueline M. Major, Aaron Niman, Shirley V. Wang, Joshua J. Gagne

08/22/2018
2018 ICPE Presentation: Minor Differences, Major Consequences? Lessons Learned from Replication of a Claims-Based Drug Safety Assessment

Ting-Ying Jane Huang, Laura Hou, Laura Shockro, Ella Pestine, Michael Nguyen, Judith C. Maro, Rima Izem

08/23/2018
2018 ICPE Presentation: Performance of a Distributed Regression Analysis Software and Workflow

Qoua L. Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Darren Toh

08/22/2018
2018 ICPE Presentation: Signal Detection using TreeScan with Drug Classes: Pilot Projects in Sentinel

Judith C. Maro, Michael D. Nguyen, Rima Izem, Ya‐Hui Hsueh, Inna Dashevsky, Austin Cosgrove, S. Christopher Jones, Jacqueline M. Major, Esther H. Zhou, Elande Baro, Joshua J. Gagne, Shirley V. Wang, Martin Kulldorff

08/23/2018
2018 ICPE Presentation: Use of Multiple Sclerosis Drugs Among Live Birth Pregnancies in the United States

Danijela Stojanovic, Mayura Shinde, Nicole Haug, Mohamed Mohamoud, Leyla Sahin, Genna Panucci, Rajani Rajbhandari, Lockwood Taylor

08/23/2018
2018 ICPE Presentation: Validation of the Combined Comorbidity Score in the ICD-10 Era: Application to High-Risk Populations

Justin Bohn, Emily C. Welch, Jenny W. Sun, Joshua J. Gagne, Sengwee Darren Toh

08/22/2018
2018 ICPE Symposium: Advances in the Study of Medication Errors in Computerized Healthcare Databases and Spontaneous Reporting Systems in Europe and North America

Michael D. Nguyen, Jo Wyeth, Kevin Haynes, Lisa Herrinton, Rodrigo Postigo, Adrian Levy, Chi-Ming (Alice) Tu

08/22/2018
2018 ICPE Workshop: Sequential and SequentialDesign: Tools For Prospective Sequential Medical Product Safety Surveillance

 Judith C. Maro, Efe Eworuke, Andreia Leite, Martin Kulldorff

08/22/2018
2019 ICPE Poster: Biosimilar Use in the United States: A Sentinel Analysis of Filgrastim and Infliximab

Sarah K. Dutcher, Efe Eworuke, Elnara Fazio-Eynullayeva, Elizabeth Dee, Michael D. Nguyen, Catherine A. Panozzo

08/28/2019
2019 ICPE Poster: Characteristics and Treatment Status of Those with Influenza-Like Illness: Implications for Effectiveness Studies and Surveillance

Crystal J. Garcia, Nicole R. Haug, Catherine A. Panozzo, Austin C. Cosgrove, Henry Francis, Alfred F. Sorbello, Orbert P. Orr, Gregory T. Measer, Sarah K. Dutcher, Noelle M. Cocoros

08/28/2019
2019 ICPE Poster: Characteristics of NOAC Users Aged Less Than 65 Years in the Sentinel System

Marie C. Bradley, Emily C. Welch, Efe Eworuke, Rongmei Zhang, Elande Baro, David J. Graham, Mayura Shinde

08/26/2019
2019 ICPE Poster: Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis

Mohamed Mohamoud, Casie Horgan, Veronica Sansing-Foster, Elizabeth Dee, Justin Bohn, Oren Shapira, Efe Eworuke, Monica Munoz, Danijela Stojanovic, Lois La Grenade

08/28/2019
2019 ICPE Poster: Confounding Variable Capture in Large Healthcare Administrative Claims Database: A Trend Analysis in the Sentinel System

Wei Liu, Austin Cosgrove, Sarah Dutcher, Justin Bohn

08/27/2019
2019 ICPE Poster: Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy

James Phillip Trinidad, Talia Menzin, Elizabeth Dee, Monique Falconer, Mayura Shinde

08/28/2019
2019 ICPE Poster: Duration of Follow-up of Chronic Condition Cohorts in the Sentinel System

Emily C. Welch, Ting-Ying Huang, Mayura Shinde, Michael D. Nugyen, Sarah K. Dutcher

08/27/2019
2019 ICPE Poster: Epidemiology of Pediatric Respiratory Syncytial Virus-Associated Illnesses in Young Children

Amol Purandare, Prabha Viswanathan, Nicole Haug, Noelle Cocoros, Rongmei Zhang, Marscha Reichman, Michael Nguyen, Ann McMahon

08/26/2019
2019 ICPE Poster: Evidence of Residual Confounding in Healthcare Database Studies of Oseltamivir and Influenza Complications

Phyo T. Htoo, Gregory Measer, Robert Orr, Justin Bohn, Alfred Sorbello, Henry Francis, Sarah Dutcher, Sengwee Darren Toh, Noelle M. Cocoros

08/26/2019
2019 ICPE Poster: Exposure to N-nitrosodimethylamine (NDMA)/N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States

Efe Eworuke, Emily C. Welch, Veronica Sansing-Foster, Marie Bradley, Judith C. Maro

08/26/2019
2019 ICPE Poster: Identification of Ordinal Endpoints Indicating Influenza Complications: A Feasibility Analysis Relevant to the Study of Medical Countermeasures

Austin Cosgrove, Nicole Haug, Catherine Panozzo, Gregory Measer, Robert Orr, Alfred Sorbello, Henry Francis, Crystal Garcia, Sarah Dutcher, Noelle Cocoros

08/28/2019
2019 ICPE Poster: Phosphodiesterase Type 5 (PDE-5) Inhibitor Use Among Pregnant Women and Women of Reproductive Age in the United States

Wei Liu, Talia Menzin, Corinne M. Woods, Nicole Haug, Jie Li, Justin A. Mathew, Christine P. Nguyen, Grace P. Chai, David Moeny, Mayura Shinde

08/26/2019