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 descending
Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program

Susan Andrade ScD; Darren Toh ScD; Monika Houstoun PharmD, MPH; Katrina Mott MHS; Marilyn Pitts PharmD; Caren Kieswetter MD, MPH; Carrie Ceresa PharmD, MPH; Katie Haffenreffer BS; Marsha Reichman PhD

Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance

Matthew F. Daley MD; Kristen Goddard MPH; Melissa McClung MSPH; Arthur Davidson MD, MPH; Gretchen Weiss MPH; Ted Palen PhD, MD, MSPH; Carsie Nyirenda MPH; Richard Platt MD, MSc; Brooke Courtney JD, MPH; Marsha E. Reichman PhD

Evaluation of the Risk of Venous Thromboembolism after Quadrivalent Human Papillomavirus Vaccination among U.S. Females

W. Katherine Yih PhD, MPH; Sharon K. Greene PhD, MPH; Lauren Zichittella MS; Martin Kulldorff PhD; Meghan A. Baker MD, ScD; Jill L.O. de Jong MD, PhD; Ruth Gil Prieto PhD, MPH, MSc; Marie R. Griffin MD, MPH; Robert Jin MS; Nancy D. Lin ScD; Cheryl McMahill-Walraven PhD, MSW; Megan Reidy MPH; Nandini Selvam; PhD, MPH; Mano Selvan PhD; Michael D. Nguyen MD

Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011

Allison L. Naleway PhD; Brad Cranea; Ning Smith; Matthew F. Daley MD; James Donahue; Julianne Gee Sharon K. Greene PhD, MPH; Theresa Harrington; Lisa A. Jackson MD, MPH; Nicola P. Klein MD, PhD; Hung Fu Tseng; Claudia Vellozzi MD; Eric S. Weintraub


The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance

Robert Ball MD, MPH, ScM; Melissa A. Robb RN; Stephen A. Anderson PhD, MPP; Gerald Dal Pan MD, MHS

Improving Therapeutic Effectiveness and Safety through Big Healthcare Data

Sebastian Schneeweiss MD, ScD

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

Rosa Gini PhD; Martijn Schuemie PhD; Jeffrey Brown PhD; Patrick Ryan PhD; Edoardo Vacchi PhD; Massimo Coppola; Walter Cazzola PhD; Preciosa Coloma MD, PhD; Roberto Berni; Gayo Diallo PhD; José Luis Oliveira PhD; Paul Avillach MD, PhD; Gianluca Trifirò MD, PhD; Peter Rijnbeek PhD, MSc; Mariadonata Bellentani; Johan van Der Lei MD, PhD; Niek Klazinga MD, PhD; Miriam Sturkenboom PhD, MS

Evaluation of Propensity Scores, Disease Risk Scores, and Regression in Confounder Adjustment for the Safety of Emerging Treatment with Group Sequential Monitoring

Stanley Xu PhD; Susan Shetterly MS; Andrea J. Cook PhD; Marsha A. Raebel PharmD; Sunali Goonesekera MS; Azadeh Shoaibi PhD, MS, MHS; Jason Roy PhD; Bruce Fireman MA

Changing Patterns of Asthma Medication use Related to U.S. Food and Drug Administration Long-Acting Beta2-agonist Regulation from 2005-2011

Melissa G. Butler PharmD, PhD, MPH; Esther H. Zhou MD, PhD; Fang Zhang PhD; Yu-te Wu PhD; Ann Chen Wu MD, MPH; Mark S. Levenson PhD; Pingsheng Wu PhD; Sally Seymour MD; Sengwee Toh ScD; Aarthi Iyer MPH; Solomon Iyasu MD, MPH; Meghan A. Baker MD, ScD

Intravenous Immune Globulin and Thromboembolic Adverse Events: A Systematic Review and Meta-Analysis of RCTs

Eric M. Ammann PhD, MS; Cole B. Haskins BS; Kelsey M. Fillman; Rebecca L. Ritter; Xiaomei Gu; Scott K. Winiecki MD; Ryan M. Carnahan PharmD, MS; James C. Torner PhD; Bruce H. Fireman MA; Michael P. Jones; Elizabeth A. Chrischilles PhD, MS

Prospective Influenza Vaccine Safety Surveillance using Fresh Data in the Sentinel System

W. Katherine Yih PhD, MPH; Martin Kulldorff PhD; Sukhminder K. Sandhu PhD, MPH, MS; Lauren Zichittella MS; Judith C. Maro PhD, MS; David V. Cole BM; Robert Jin MS; Alison Tse Kawai ScD; Meghan A. Baker MD, ScD; Chunfu Liu ScD; Cheryl N McMahill-Walraven PhD, MSW; Mano S. Selvan PhD; Richard Platt MD, MSc; Michael Nguyen MD; Grace M. Lee MD, MPH

Uptake of New Drugs in the Early Post-Approval Period in the Mini-Sentinel Distributed Database

Katrina Mott MS; David J. Graham MD, MPH; Sengwee Toh ScD; Joshua J. Gagne PharmD, ScD; Mark Levenson PhD; Yong Ma PhD, MS; Marsha E. Reichman PhD

Methods for using Clinical Laboratory Test Results as Baseline Confounders in Multi-Site Observational Database Studies when Missing Data are Expected

Marsha A. Raebel PharmD; Susan Shetterly MS; Christine Y. Lu PhD, MSc; James S. Flory MD, MS; Joshua J. Gagne PharmD, ScD; Frank E. Harrell PhD; Kevin Haynes PharmD, MSCE; Lisa J. Herrinton PhD; Elisabetta Patorno MD, DrPH; Jennifer Popovic DVM, MA; Mano Selvan PhD; Azadeh Shoaibi PhD, MHS; Xingmei Wang MS; Jason Roy PhD

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

Susan E. Andrade ScD; Marsha E. Reichman PhD; Katrina Mott MS; Marilyn Pitts PharmD; Caren Kieswetter MD, MPH; Miriam Dinatale DO; Marc B. Stone MD; Jennifer Popovic DVM, MA; Katherine Haffenreffer BS; Sengwee Toh ScD

Evidence Generation from Healthcare Databases: Recommendations for Managing Change

Alison Bourke, Andrew Bate PhD; Brian C. Sauer PhD, MS; Jeffrey S. Brown PhD; Gillian C. Hall PhD

Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study

Darren Toh ScD; Christian Hampp PhD; Marsha E. Reichman PhD; David J. Graham MD, MPH; Suchitra Balakrishnan; Frank Pucino; Jack Hamilton; Samuel Lendle; Aarthi Iyer MPH; Malcolm Rucker MS; Madelyn Pimentel BA; Neesha Nathwani; Marie R. Griffin MD, MPH; Nancy J. Brown; Bruce H. Fireman MA 

Quantitative Bias Analysis in Regulatory Settings

Timothy L. Lash DSc, MPH; Matthew P. Fox DSc, MPH; Darryl Cooney MStat; Yun Lu PhD, MS; Richard A. Forshee PhD

Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association

Susan Gruber PhD, MPH; Aloka Chakravarty PhD; Susan R. Heckbert MD, PhD; Mark S. Levenson PhD; David Martin MD, MPH; Jennifer C. Nelson PhD; Bruce M. Psaty MD, PhD; Simone Pinheiro ScD, MSc; Christian G. Reich MD, PhD; Sengwee Toh ScD; Alexander M. Walker MD, PhD

Use of Electronic Health Data to Estimate Heart Failure Events in a Population-Based Cohort with CKD

James S. Floyd MD, MS; Robert Wellman MS; Sharon Fuller MA; Nisha Bansal MD, MAS; Bruce M. Psaty MD, PhD; Ian H. de Boer MD, MS; Delia Scholes PhD, MPH

Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

Joshua Gagne PharmD, ScD; X. Han PharmD, PhD, MS; Sean Hennessy PharmD, PhD; Charles E. Leonard PharmD, MSCE; Elizabeth Chrischilles PhD, MS; Ryan M. Carnahan PharmD, MS, BCPP; Shirley V. Wang PhD; Candace Fuller PhD; Aarthi Iyer MPH; Hannah Katcoff MPH; Tiffany S. Woodworth MPH; Patrick Archdeacon MD; Tamra E. Meyer PhD; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD

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

Joshua Gagne

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

Lockwood G. Taylor

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

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

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

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

Martin Kulldorff, Katherine Yih

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

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

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

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

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

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

Darren Toh

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

A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data

Jennifer C. Nelson PhD; Robert Wellman MS; Onchee Yu MS; Andrea J. Cook PhD; Judith C. Maro PhD; Rita Ouellet-Hellstrom PhD, MPH; Denise Boudreau RPh, PhD; James S. Floyd MD, MS; Susan R. Heckbert MD, PhD; Simone Pinheiro ScD, MSc; Marsha Reichman PhD; Azadeh Shoaibi PhD, MHS, MS

The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies

Elisabetta Patorno MD, DrPH; Joshua Gagne PharmD, ScD; Christine Lu PhD, MSc; Kevin Haynes PharmD, MSCE; Andrew Sterret PhD; Jason Roy PhD; Marsha Raebel PharmD; Xingmei Wang MS

Distributed Data Networks: A Blueprint for Big Data Sharing and Healthcare Analytics

Jennifer R. Popovic DVM, MA

Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making

Sebastian Schneeweiss MD, ScD; Hans Georg Eichler MD, MSc; Anna Garcia-Altes; Chris Chinn; Anne-Virginie Eggimann; Sarah E. Garner; W. Goettsch; Robyn R. Lim; W. Löbker; David Martin MD, MPH; T. Müller; B.J. Park; Richard Platt MD, MSc; Sarah A. Priddy; Michael Ruhl; Almoth Spooner; B Vannieuwenhuyse; Richard J Willke

Missing Laboratory Results Data in Electronic Health Databases: Implications for Monitoring Diabetes Risk

James H. Flory MD, MS; Jason Roy PhD; Joshua Gagne PharmD, ScD; Kevin Haynes PharmD, ScD; Lisa Herrinton PhD; Elisabetta Patorno MD, DrPH; Azadeh Shoaibi PhD, MHS; Marsha Raebel PharmD; Christine Lu PhD, MSc 

Antiemetic use among Pregnant Women in the United States: the Escalating use of Ondansetron

Lockwood G. Taylor PhD, MPH; Steven T. Bird PharmD, PhD, MS; Leyla Sahin MD; Melissa S. Tassinari PhD; Patty Greene PharmD; Marsha E. Reichman PhD; Susan E. Andrade ScD; Katherine Haffenreffer BS; Sengwee Toh ScD

Statistical Power for Postlicensure Medical Product Safety Data-Mining

Judith C. Maro PhD; Michael D. Nguyen MD; Inna Dashevsky MS; Meghan A. Baker MD, ScD; Martin Kulldorff PhD

Sentinel Modular Program for Propensity-Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia

Sean Hennessy PharmD, PhD; Meijia Zhou MHS; Shirley V. Wang PhD, ScM; Charles E. Leonard PharmD, MSCE; Joshua J. Gagne PharmD, ScD; Candace Fuller PhD; Christian Hampp PhD; Patrick Archdeacon MD; Sengwee Toh ScD; Aarthi Iyer MPH; Tiffany S. Woodworth MPH; Elizabeth Cavagnaro MPH; Catherine A. Panozzo PhD; Sophia Axtman; Ryan M. Carnahan PharmD, MS, BCPP; Elizabeth Chrischilles PhD, MS

Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners

Crystal Garcia MPH; Candace Fuller PhD; Madelyn Pimentel BA; Eric Ammann MS; Elizabeth Chrischilles PhD, MS; Scott Winiecki MD

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

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

Noelle Cocoros on behalf of Crystal Garcia

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

Sascha Dublin

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

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

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

Noelle Cocoros

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

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

Richard Scott Swain

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

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

Noelle Cocoros

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

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

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

Wendy Camello Castillo

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

Elizabeth Chrischilles

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

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

Crystal Garcia

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

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

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

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

Genna Panucci

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

Katherine Yih

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

Efe Eworuke

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

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

Tiffany Siu Woodworth

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

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

Judith Maro, Rima Izem, Martin Kulldorff, Azadeh Shoaibi

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

Emily C. Welch

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

Michael Nguyen

Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies

Steven T. Bird PharmD, PhD, MS; Kate Gelperin MD; Lockwood Taylor PhD, MPH; Leyla Sahin MD; Hoda Hammad MS, MPH; Susan E. Andrade ScD; Mohamed A. Mohamoud PharmD, MPH; Sengwee Toh, ScD; Christian Hampp PhD

The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011

Meghan A. Baker MD, ScD; Melissa G. Butler PharmD, PhD, MPH; Sally Seymour MD; Fang Zhang PhD; Yute Wu PhD; Ann Chen Wu MD, MPH; Mark S. Levenson PhD; Pingsheng Wu PhD; Aarthi Iyer MPH; Sengwee Toh ScD; Solomon Iyasu MD, MPH; Esther H. Zhou MD, PhD

PDUFA V Commitment: Sentinel Program Interim and Final Assessments 09/27/2017
Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network

John G. Connolly SM; Shirley V. Wang PhD, ScM; Candace C. Fuller PhD; Sengwee Toh ScD; Catherine A. Panozzo PhD; Noelle Cocoros DSc; Meijia Zhou MHS; Joshua J. Gagne PharmD, ScD; Judith C. Maro PhD, MS

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

Shirley V. Wang PhD, ScM; Mengdong He MS; Yinzhu Jin MS, MPH; Richard Wyss PhD; HoJin Shin MS; Yong Ma PhD, MS; Stephine Keeton PhD; Bruce Fireman MA; Sara Karami PhD, MPH; Jacqueline M. Major PhD; Sebastian Schneeweiss MD, ScD; Joshua Gagne PharmD, ScD

Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia (Video Abstract)

Meijia Zhou, Sean Hennessy