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.

Title Authors Date Postedsort ascending
Concomitant Filled Prescriptions of Oxymorphone or Oxycodone with CYP3A Inhibitors and Inducers

D. Tyler Coyle, Tiffany S. Woodworth, David Moeny, Judy Staffa, Tamra Meyer, Corinne Woods, Emily C. Welch, Kevin Haynes, Sengwee Toh, Judith C. Maro

Conducting Prospective Sequential Surveillance in Real‐World Dynamic Distributed Databases

Judith C. Maro, Efe Eworuke, Laura Hou, Emily C. Welch, Margie R. Goulding, Rima Izem, Joo‐Yeon Lee, Sengwee Toh, Bruce Fireman, Michael D. Nguyen

Assessing Natural History, Drug Use and Treatment Impact for COVID-19 in the Sentinel System

Robert Ball, Jennifer Stacey, Jeffrey S. Brown

2018 ICPE Symposium: Adventures in Replication: Initial Experiences related to the Joint ISPE/ISPOR Guidance

Judith C. Maro, Shirley V. Wang, Ting-Ying (Jane) Huang, Robert W. Platt, Xavier Kurz

Medical Product Safety Surveillance: Data Quality in the Sentinel Initiative

Judith C. Maro

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

Jeffrey S. Brown, Judith C. Maro, Michael Nguyen, Robert Ball

Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer

Darren Toh

Canadian Mother-Child Cohort (CAMCCO) Active Surveillance 1st Team and Stakeholders Symposium: Sentinel Mother-Infant Linkage and Pregnancy Analyses

Elizabeth Suarez

Translating Claims‐Based CHA2DS2‐VaSc and HAS‐BLED to ICD‐10‐CM: Impacts of Mapping Strategies

Michael Webster‐Clark, Ting‐Ying Huang, Laura Hou, Sengwee Toh

The Risk of Febrile Seizures following Influenza and 13-Valent Pneumococcal Conjugate Vaccines

Meghan A. Baker, Christopher Jankosky, Katherine Yih, Susan Gruber, Lingling Li, Noelle M. Cocoros, Hana Lipowicz, Claudia Coronel-Moreno, Sandra DeLuccia, Nancy D. Lin, Cheryl N. McMahill-Walraven, David Menschik, Mano S. Selvan, Nandini Selvam, Rong Chen Tilney, Lauren Zichittella, Grace M. Lee, Alison Tse Kawai

Understanding Utilization Patterns of Biologics and Biosimilars in the United States to Support Postmarketing Studies of Safety and Effectiveness

Sarah K. Dutcher, Elnara Fazio‐Eynullayeva, Efe Eworuke, Amanda Carruth, Elizabeth C. Dee, Michael D. Blum, Michael D. Nguyen, Sengwee Toh, Catherine A. Panozzo, Jennifer G. Lyons

Medical Product Safety Surveillance: Data Quality in the Sentinel Initiative

Judith C. Maro

Use of Antidiabetic Drugs During Pregnancy among U.S. Women with Livebirth Deliveries in the Mini-Sentinel System

Katrina Mott, Marsha E. Reichman, Sengwee Toh, Caren Kieswetter, Katherine Haffenreffer, Susan E. Andrade 

Redesigning PopMedNet for Distributed Regression Analysis with Vertically Partitioned Data

Qoua L. Her

Quantifying How Small Variations in Design Elements Affect Risk in an Incident Cohort Study in Claims

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

2019 AHA Scientific Sessions Poster: Myopathy and Rhabdomyolysis with Concomitant Use of Ticagrelor and High-Intensity Statins in the Elderly

Mohamed Mohamoud, Daniel Woronow, Nicole Haug, Daniel Bak, Eileen Wu, Corinne Woods, Monica Munoz, Grace Chai, Danijela Stojanovic, Ting-Ying Huang

Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy

Janet Sultana, Francesco Trotta, Antonio Addis, Jeffrey S. Brown, Miguel Gil, Francesca Menniti-Ippolito, Federica Milozzi, Samy Suissa, Gianluca Trifirò

Reproducing Protocol‐based Studies Using Parameterizable Tools – Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks

Ting‐Ying Huang, Emily C. Welch, Mayura U. Shinde, Robert W. Platt, Kristian B. Filion, Laurent Azoulay, Judith C. Maro, Richard Platt, Sengwee Toh

Use of Time-Dependent Propensity Scores to Adjust Hazard Ratio Estimates in Cohort Studies with Differential Depletion of Susceptibles

Richard Wyss, Joshua Gagne, Yueqin Zhao, Esther Zhou, Jacqueline Major, Shirley Wang, Rishi Desai, Jessica Franklin, Sebastian Schneeweiss, Sengwee Toh, Margaret Johnson, Bruce Fireman

Identification of Potential Drug Name Confusion Errors in the Sentinel System

Noelle M. Cocoros, Kevin Haynes, Qoua Her, Austin Cosgrove, Elizabeth Dee, Nancy D. Lin, Chi‐Ming Tu, Yulan Ding, Michael Nguyen, Sengwee Toh

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

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

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

2019 ICPE Poster: Utilization of Prescription Anti-Obesity Drugs in the U.S. Food and Drug Administration's (FDA) Sentinel System, 2008-2017

Sara Azimi-Bolourian, Emily C. Welch, Candace C. Fuller, Rajani Rajbhandari, Christian Hampp, Michael D. Nguyen

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

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

2019 ICPE Presentation: Utility of Prenatal Tests and Fertility Coding to Estimate Pregnancy Start in the Sentinel Distributed Database

Lockwood G. Taylor, Steven T. Bird, Danijela Stojanovic, Darren Toh, Elnara Fazio-Eynullayeva, Andrew Petrone, Rajani Rajbhandari, Jennifer G. Lyons

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

2019 ICPE Presentation: 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Kawasaki Disease

Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, Katherine Yih

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

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

2019 ICPE Presentation: Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings

Marie Bradley

2019 ICPE Presentation: A General Propensity Score for Signal Detection using Tree-Based Scan Statistics

Shirley V. Wang, Joshua J. Gagne, Judith C. Maro, Sushama Kattinakere, Danijela Stojanovic, Efe Eworuke, Elande Baro, Rita Ouellet-Hellstrom, Michael Nguyen, Elisabetta Patorno, Sandra DeLuccia, Ella Pestine, Yong Ma, Martin Kulldorff

2019 ICPE Symposium: Thinking Globally While Acting Locally: Developing Time-on-Treatment Data In International Settings

Judith C. Maro, Kristian B. Fillion, Achim Wolf, Kevin Haynes, Michael D. Nguyen

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

2019 ICPE Symposium: Experience from US FDA Sentinel Initiative Studies

Darren Toh

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

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

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

First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies

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

Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations

James E. Sabin, Noelle M. Cocoros, Crystal J. Garcia, Jennifer C. Goldsack, Kevin Haynes, Nancy D. Lin, Debbe McCall, Vinit Nair, Sean D. Pokorney, Cheryl N. McMahill‐Walraven, Christopher B. Granger, Richard Platt

Development of an Algorithm to Detect Methotrexate Wrong Frequency Error Using Computerized Health Care Data

Lisa J. Herrinton, Tiffany S. Woodworth, Efe Eworuke, Laura B. Amsden, Liyan Liu, Jo Wyeth, Andrew Petrone, Talia J. Menzin, James Williams, Robert Goldfien, Michael Nguyen

Kawasaki Disease and 13-Valent Pneumococcal Conjugate Vaccination Among Young Children: A Self-Controlled Risk Interval and Cohort Study with Null Results

Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, W. Katherine Yih

Signal Identification Methods in the Sentinel System

Judith Maro

Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program

Alison Tse Kawai, David Martin, Sarah E. Henrickson, Ashleigh Goff, Megan Reidy, Diana Santiago, Nandini Selvam, Mano Selvan, Cheryl McMahill-Walraven, Grace M. Lee

Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population

Lockwood G. Taylor, Genna Panucci, Andrew D. Mosholder, Sengwee Toh, Ting-Ying Huang

Medical Product Safety: Ten Years of the U.S. Sentinel System

Sarah Dutcher, Judith C. Maro, David Martin

Evaluation of Use of Technologies to Facilitate Medical Chart Review

Loreen Straub, Joshua J. Gagne, Judith C. Maro, Michael D. Nguyen, Nicolas Beaulieu, Jeffrey S. Brown, Adee Kennedy, Margaret Johnson, Adam Wright, Li Zhou, Shirley V. Wang

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

Jennifer C. Nelson, Ernesto Ulloa-Pe’rez, Jennifer F. Bobb, Judith C. Maro

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

Andrea J. Cook, Robert D. Wellman, Tracey Marsh, Azadeh Shoaibi, Ram C. Tiwari, Michael Nguyen, Denise Boudreau, Eric S. Weintraub, Lisa Jackson, Jennifer C. Nelson

Evaluating the Use of Bootstrapping in Cohort Studies Conducted with 1:1 Propensity Score Matching — A Plasmode Simulation Study

Rishi J. Desai, Richard Wyss, Younathan Abdia, Sengwee Toh, Margaret Johnson, Hana Lee, Sara Karami, Jacqueline M. Major, Michael Nguyen, Shirley V. Wang, Jessica M. Franklin, Joshua J. Gagne

The Devil's in the Details: Reports on Reproducibility in Pharmacoepidemiologic Studies

Andrew B. Petrone, April DuCott, Joshua J. Gagne, Sengwee Toh, Judith C. Maro

Evidence from Real-World Data Sentinel Initiative of U.S. FDA

Darren Toh

Cross‐Network Directory Service: Infrastructure to Enable Collaborations Across Distributed Research Networks

Jessica M. Malenfant, Jenny Hochstadt, Bridget Nolan, Kimberly Barrett, Dean Corriveau, Daniel Dee, Marcelline Harris, Chayim Herzig‐Marx, Vinit P. Nair, Zachary Wyner, Jeffrey S. Brown

A New Analytic Tool Developed in the Sentinel System to Assess Safe Use Recommendations

Noelle M. Cocoros, Anita Wagner, Kevin Haynes, Andrew B. Petrone, Elnara Fazio‐Eynullayeva, Yulan Ding, Rima Izem, Joo‐Yeon Lee, Jacqueline M. Major, Michael Nguyen, Jing Ju

Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure

Efe Eworuke, Emily C. Welch, Anne Tobenkin, Judith C. Maro

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

Ryan M. Carnahan, Joshua J. Gagne, Christian Hampp, Charles E. Leonard, Sengwee Toh, Candace C. Fuller, Sean Hennessy, Laura Hou, Noelle M. Cocoros, Genna Panucci, Tiffany Woodworth, Austin Cosgrove, Aarthi Iyer, Elizabeth A. Chrischilles

How Pharmacoepidemiology Networks Can Manage Distributed Analyses to Improve Replicability and Transparency and Minimize Bias

Robert W. Platt, Richard Platt, Jeffrey S. Brown, David A. Henry, Olaf H. Klungel, Samy Suissa

FDA Voices: The Future of FDA's Electronic Safety Surveillance

Scott Gottlieb and Gerald Dal Pan

Sentinel System Five-Year Strategy: 2019-2023

U.S. Food and Drug Administration

Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel

Danijela Stojanovic

Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10

Elizabeth Suarez

Drug Safety in Pregnancy in a Large, Multisite Database: Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System

Susan Andrade

Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App

David Martin

The FDA Sentinel Initiative — An Evolving National Resource

Richard Platt, Jeffrey S. Brown, Melissa Robb, Mark McClellan, Robert Ball, Michael D. Nguyen, Rachel E. Sherman

Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review

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

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

Sean D. Pokorney, Kevin Haynes, Crystal Garcia, Hussein R. Al-Khalidi, Sana M. Al-Khatib, Patrick Archdeacon, Jennifer C. Goldsack, Thomas Harkins, Nancy D. Lin, David Martin, Debbe McCall, Vinit Nair, Lauren Parlett, Robert Temple, Cheryl McMahill-Walraven, Christopher B. Granger, Richard Platt

Use of Tumor Necrosis Factor-alpha Inhibitors During Pregnancy Among Women Who Delivered Liveborn Infants

Efe Eworuke, Genna Panucci, Margie Goulding, Rosemarie Neuner, Sengwee Toh

Overall and Cause-Specific Mortality in the Sentinel System: A Power Analysis

Richard S. Swain, Lockwood G. Taylor, Tiffany S. Woodworth, Candace C. Fuller, Andrew B. Petrone, Talia J. Menzin, Nicole R. Haug, Sengwee Toh, Andrew D. Mosholder

Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance

Zachary Wyner, Juliane Reynolds, Chayim Herzig-Marx, Shyam Deval, Adam Rauch, Jeffrey Brown, David Martin

A Generalizable Smartphone-Based Clinical Research Platform

Zachary Wyner

Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System

Noelle M. Cocoros, Marc R. Larochelle, Jennifer Popovic, Andrew B. Petrone, Cynthia Kornegay, Jing Ju, Judith A. Racoosin

Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative

Judith C. Maro

Misclassification in Assessment of First Trimester In-Utero Exposure to Drugs used Proximally to Conception - The Example of Letrozole Utilization for Infertility Treatment

Steven T. Bird, Sengwee Toh, Leyla Sahin, Susan E. Andrade, Kate Gelperin, Lockwood Taylor, Jaejoon Song, Christian Hampp

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

Jie Li, Genna Panucci, David Moeny, Wei Liu, Judith C. Maro, Sengwee Toh, Ting-Ying Huang