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
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

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

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

Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs

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

Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study

Andrew D. Mosholder, Lockwood Taylor, Glenn Mannheim, Lisa Ortendahl, Tiffany S. Woodworth, Sengwee Toh

Data Enclaves for Sharing Information Derived From Clinical and Administrative Data

Richard Platt and Tracy Lieu

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

Outpatient Influenza Antivirals in a Distributed Data Network for Influenza Surveillance

Noelle M. Cocoros, Genna Panucci, Nicole Haug, Carmen Maher, Marsha Reichman, Sengwee Toh

Assessing the Impact of the New ICD‐10‐CM Coding System on Pharmacoepidemiologic Studies — An Application to the Known Association 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

Early Impact of the ICD‐10‐CM Transition on Selected Health Outcomes in 13 Electronic Health Care Databases in the United States

Catherine A. Panozzo, Tiffany S. Woodworth, Emily C. Welch, Ting‐Ying Huang, Qoua L. Her, Kevin Haynes, Catherine Rogers, Talia J. Menzin, Max Ehrmann, Katherine E. Freitas, Nicole R. Haug, Sengwee Toh

Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes of Interest- An Empirical Evaluation

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

Diagnosis‐Based Cohort Augmentation using Laboratory Results Data: The Case of Chronic Kidney Disease

David Smith, Susan Shetterly, James Flory, Kevin Haynes, Christine Lu, Joshua Gagne, Lisa Herrinton, Carsie Nyirenda, Elisabetta Patorno, Azadeh Shoaibi, Marsha Raebel 

Outcome Identification in Electronic Health Records using Predictions from an Enriched Dirichlet Process Mixture

Bret Zeldow, James Flory, Alisa Stephens-Shields, Marsha Raebel, Jason Roy

A Query Workflow Design to Perform Automatable Distributed Regression Analysis in Large Distributed Data Networks

Qoua L. Her, Jessica M. Malenfant, Sarah Malek, Yury Vilk, Jessica Young, Lingling Li, Jeffery Brown, Sengwee Toh

Small Changes, Big Differences? Cohort Variation by Parameter Specifications in Claims-Based Drug Use Evaluations

Ting-Ying Huang, Laura Shockro, Ella Pestine, Michael Nguyen, Judith Maro, Rima Izem

Relative Performance of Propensity Score Matching Strategies for Subgroup Analyses

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

Evaluation of the US Food and Drug Administration Sentinel Analysis Tools in Confirming Previously Observed Drug-Outcome Associations: The Case of Clindamycin and Clostridium difficile Infection

Ryan M. Carnahan, Jennifer L. Kuntz, Shirley V. Wang, Candace Fuller, Joshua J. Gagne, Charles E. Leonard, Sean Hennessy, Tamra Meyer, Patrick Archdeacon, Chih‐Ying Chen, Catherine A. Panozzo, Sengwee Toh, Hannah Katcoff, Tiffany Woodworth, Aarthi Iyer, Sophia Axtman, Elizabeth A. Chrischilles

Utilization of Drugs with Pregnancy Exposure Registries During Pregnancy

Onyekachukwu A. Illoh, Sengwee Toh, Susan E. Andrade, Christian Hampp, Leyla Sahin, Kate Gelperin, Lockwood Taylor, Steven T. Bird

Sequential Surveillance for Drug Safety in a Regulatory Environment

David Martin MD, MPH; Joshua J. Gagne PharmD, ScD; Susan Gruber PhD, MPH; Rima Izem PhD; Jennifer C. Nelson PhD; Michael D. Nguyen MD; Rita Ouellet-Hellstrom PhD, MPH; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD; Alexander M. Walker MD, PhD

Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Venous Thromboembolism among Intravenous Immune Globulin Users in the Sentinel Distributed Database

Eric M. Ammann, Adam Cuker, Ryan M. Carnahan, Usha S. Perepu, Scott K. Winiecki, Marin L. Schweizer, Charles E. Leonard, Candace C. Fuller, Crystal Garcia, Cole Haskins, Elizabeth A. Chrischilles

Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System

W. Katherine Yih PhD, MPH; Judith C. Maro PhD; Michael Nguyen MD; Meghan A. Baker MD, ScD; Carolyn Balsbaugh MPH; David V. Cole BM; Inna Dashevsky MS; Adamma Mba-Jonas MD; Martin Kulldorff PhD

Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Acute Myocardial Infarction (AMI) Among Intravenous Immune Globulin (IGIV) Users in the Sentinel Distributed Database

Eric M. Ammann PhD, MS; Marin L. Schweizer PhD; Jennifer G. Robinson MD, MPH; Jayasheel O. Eschol MD; Rami Kafa MD; Saket Girotra MD, MS; Scott K. Winiecki MD; Candace C. Fuller PhD; Ryan M. Carnahan PharmD, MS, BCPP; Charles E. Leonard PharmD, MSCE; Cole Haskins BS; Crystal Garcia MPH; Elizabeth A. Chrischilles PhD, MS

Sentinel Initiative Principles and Policies: HIPAA and Common Rule Compliance

Kristen Rosati, Naomi Jorgensen, and Melissa Soliz, Coppersmith Brockelman PLC

Barbara J. Evans, University of Houston

Butterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal Inference

Rima Izem PhD

Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System

Elizabeth A. Chrischilles PhD, MS; Joshua J. Gagne PharmD, ScD; Bruce Fireman MA; Jennifer Nelson PhD; Sengwee Toh ScD; Azadeh Shoaibi PhD, MHS; Marsha E. Reichman PhD; Shirley Wang PhD, ScM; Michael Nguyen MD; Rongmei Zhang PhD; Rima Izem PhD; Margie R. Goulding PhD; Mary Ross Southworth PharmD; David J. Graham MD, MPH; Candace Fuller PhD; Hannah Katcoff MPH; Tiffany Woodworth MPH; Catherine Rogers MPH; Ryan Saliga BBA; Nancy D. Lin ScD; Cheryl N. McMahill-Walraven PhD, MSW; Vinit P. Nair BPharm, MS, RPh; Kevin Haynes PharmD, MSCE; Ryan M. Carnahan PharmD, MS, BCPP

Methods for Examining Data Quality in Healthcare Integrated Data Repositories

Vojtech Huser, Michael Kahn, and Jeffrey Brown

Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database

Eric M. Ammann MS; Enrique C. Leira MD, MS; Scott K. Winiecki MD; Nandakumar Nagaraja MD, MS; Sudeepta Dandapat MD; Ryan M. Carnahan PharmD, MS, BCPP; Marin L. Schweizer PhD; James C. Torner PhD; Candace C. Fuller PhD; Charles E. Leonard PharmD, MSCE; Crystal Garcia MPH; Madelyn Pimentel; Elizabeth A. Chrischilles PhD, MS

CDER Conversation: The FDA’s Sentinel Initiative 11/27/2017
Opioid Tolerance and Urine Drug Testing among Initiates of Extended-Release or Long-Acting Opioids in Food and Drug Administration's Sentinel System

Marc R. Larochelle MD, MPH; Noelle M. Cocoros DSc, MPH; Jennifer Popovic DVM, MA; Elizabeth C. Dee MPH; Cynthia Kornegay PhD; Jing Ju PharmD, PhD; Judith A. Racoosin MD, MPH

Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study

Alan S. Go MD; Daniel E. Singer MD; Sengwee Toh ScD; T. Craig Cheetham PharmD, MS; Marsha E. Reichman PhD; David J. Graham MD, MPH; Mary Ross Southworth PharmD; Rongmei Zhang PhD; Rima Izem PhD; Margie R. Goulding PhD; Monika Houstoun PharmD; Katrina Mott MS; Sue Hee Sung MPH; Joshua J. Gagne PharmD, ScD

Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System

Joshua J. Gagne PharmD, ScD; Monika Houstoun PharmD; Marsha E. Reichman PhD; Christian Hampp PhD; James H. Marshall MPH; Sengwee Toh ScD

Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study

Sengwee Toh ScD; Marsha E. Reichman PhD; David J. Graham MD, MPH; Christian Hampp PhD; Rongmei Zhang PhD; Melissa G. Butler PharmD PhD; Aarthi Iyer MPH; Malcolm Rucker MS; Madelyn Pimentel BA; Jack Hamilton; Samuel Lendle; Bruce H. Fireman MA; the Mini-Sentinel Saxagliptin-AMI Surveillance Writing Group

Pharmacoepidemiology in the Era of Real-World Evidence

Sengwee Toh ScD

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

PDUFA V Commitment: Sentinel Program Interim and Final Assessments 09/27/2017
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

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

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

Michael Nguyen

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

Sascha Dublin

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

Noelle Cocoros on behalf of Crystal Garcia

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

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

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

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

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

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 

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

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

Jennifer R. Popovic DVM, MA

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

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

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

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