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
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: 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: 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: 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: 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: 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
A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions

Becky A. Briesacher PhD; Stephen B. Soumerai ScD; Fang Zhang PhD; Sengwee Toh ScD; Susan Andrade ScD; Jerry H. Gurwitz MD; Joann L. Wagner MSW; Azadeh Shaoibi PhD, MS, MHS 

07/12/2013
A Generalizable Smartphone-Based Clinical Research Platform

Zachary Wyner

11/05/2018
A Policy Framework for Public Health uses of Electronic Health Data

Deven McGraw JD, LLM; Kristen B. Rosati JD; Barbara Evans PhD, JD

01/19/2012
A Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical Agent

Bruce Fireman MA; Sengwee Toh ScD; Melissa G. Butler PharmD, PhD, MPH; Alan S. Go MD; Hylton V. Joffe MD, MMSc; David J. Graham MD, MPH; Jennifer C. Nelson PhD; Gregory W. Daniel PhD, MPH, RPH; Joe V. Selby MD, MPH

01/18/2012
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

05/25/2018
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

10/06/2017
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

09/06/2016
A Systematic Review of Validated Methods for Identifying Acute Respiratory Failure using Administrative and Claims Data

Gary Schneider ScD, MSPH; Natalie Jones BS; Sumesh Kachroo PhD, MS, BPharm; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD

01/19/2012
A Systematic Review of Validated Methods for Identifying Anaphylaxis, Including Anaphylactic Shock and Angioneurotic Edema, using Administrative and Claims Data

Gary Schneider ScD, MSPH; Philip Rotella MS; Sumesh Kachroo PhD, MS, BPharm; Natalie Jones BS; Sheila Crean MPH; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD

01/19/2012
A Systematic Review of Validated Methods for Identifying Atrial Fibrillation using Administrative Data

Paul N. Jensen BA; Karin Johnson PhD; James Floyd MD; Susan R. Heckbert MD, PhD; Ryan Carnahan PharmD, MS, BCPP; Sascha Dublin MD, PhD

01/19/2012
A Systematic Review of Validated Methods for Identifying Bell's Palsy using Administrative or Claims Data

Christopher D. Lee MD, MPH; Ryan Carnahan PharmD, MS, BCPP; Melissa L. McPheeters PhD, MPH

12/30/2013
A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack using Administrative Data

Susan Andrade ScD; Leslie Harrold MD, MPH; Jennifer Tjia MD, MSCE; Sarah Cutrona MD; Jane Saczynski PhD; Katherine S. Dodd; Robert Goldberg PhD; Jerry Gurwitz MD; Meyers Primary Care Institute and University of Massachusetts Medical School, Worcester, MA

02/05/2012
A Systematic Review of Validated Methods for Identifying Depression using Administrative Data

Lisa Townsend PhD; James T. Walkup PhD; Stephen Crystal PhD; Mark Olfson MD

01/19/2012
A Systematic Review of Validated Methods for Identifying Erythema Multiforme Major/Minor/Not otherwise specified, Stevens–Johnson Syndrome, or Toxic Epidermal Necrolysis using Administrative and Claims Data

Gary Schneider ScD, MSPH; Sumesh Kachroo PhD, MS, BPharm; Natalie Jones BS; Sheila Crean MPH; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD

01/19/2012
A Systematic Review of Validated Methods for Identifying Heart Failure using Administrative Data

Jane Saczynski PhD; Susan Andrade ScD; Leslie Harrold MD, MPH; Jennifer Tjia MD, MSCE; Sarah Cutrona MD; Katherine S. Dodd; Robert Goldberg PhD; Jerry Gurwitz MD

01/19/2012
A Systematic Review of Validated Methods for Identifying Hypersensitivity Reactions other than Anaphylaxis (Fever, Rash, and Lymphadenopathy), using Administrative and Claims Data

Gary Schneider ScD, MSPH; Sumesh Kachroo PhD, MS, BPharm; Natalie Jones BS; Sheila Crean MPH; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD; United BioSource Corporation, Epidemiology and Database Analytics, Lexington, MA

 

01/19/2012
A Systematic Review of Validated Methods for Identifying Infection Related to Blood Products, Tissue Grafts, or Organ Transplants using Administrative Data

Ryan Carnahan PharmD, MS, BCPP; Kevin Moores PharmD; Eli Perencevich MD, MS; The University of Iowa, Iowa City, IA

02/05/2012
A Systematic Review of Validated Methods for Identifying Kawasaki Disease using Administrative or Claims Data

Candice L. Williams MD, MPH; Nila A. Sathe MA, MLIS; Melissa McPheeters PhD, MPH

12/30/2013
A Systematic Review of Validated Methods for Identifying Lymphoma using Administrative Data

Ronald Herman PhD; Bradley Gilchrist BS; Brian Link MD; Ryan Carnahan PharmD, MS

02/05/2012
A Systematic Review of Validated Methods for Identifying Orthopedic Implant Removal and Revision using Administrative Data

Jasvinder A. Singh MD, MPH; Joseph A. Kundukulam BS; Mohit Bhandari MD, MSc

01/19/2012
A Systematic Review of Validated Methods for Identifying Pancreatitis using Administrative Data

Kevin Moores PharmD; Bradley Gilchrist BS; Thad Abrams MD, MSc; Ryan Carnahan PharmD, MS

02/05/2012
A Systematic Review of Validated Methods for Identifying Patients with Rheumatoid Arthritis using Administrative or Claims Data

Cecilia P. Chung MD, MPH; Patricia Rohan MD; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH

12/30/2013
A Systematic Review of Validated Methods for Identifying Pulmonary Fibrosis and Interstitial Lung Disease using Administrative and Claims Data

Gary Schneider ScD, MSPH; Natalie Jones BS; Sumesh Kachroo PhD; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD; United BioSource Corporation, Epidemiology and Database Analytics, Lexington, MA

02/05/2012
A Systematic Review of Validated Methods for Identifying Seizures, Convulsions, or Epilepsy using Administrative and Claims Data

Vicki Kee PharmD; Bradley Gilchrist BS; Mark A. Granner MD; Nicola R. Sarrazin PharmD; Ryan M. Carnahan PharmD, MS

01/18/2012
A Systematic Review of Validated Methods for Identifying Suicide or Suicidal Ideation using Administrative or Claims Data

James T. Walkup PhD; Lisa Townsend PhD; Stephen Crystal PhD; Mark Olfson MD, MPH

01/19/2012
A Systematic Review of Validated Methods for Identifying Systemic Lupus Erythematosus (SLE) using Administrative or Claims Data

Kevin G. Moores PharmD; Nila Sathe MA, MLIS

12/30/2013
A Systematic Review of Validated Methods for Identifying Transfusion-Related ABO Incompatibility Reactions using Administrative and Claims Data

Ryan Carnahan PharmD, MS, BCPP; Vicki Kee PharmD

01/19/2012
A Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims Data

Ryan Carnahan, PharmD, MS, BCPP, Ronald Herman, PhD, Kevin G. Moores, PharmD

02/05/2012
A Systematic Review of Validated Methods for Identifying Transverse Myelitis using Administrative or Claims Data

S. Elizabeth Williams MD; Ryan Carnahan PharmD, MS, BCPP; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH

12/30/2013
A Systematic Review of Validated Methods for Identifying Uveitis using Administrative or Claims Data

S. Elizabeth Williams MD; Ryan Carnahan PharmD, MS, BCPP; Melissa L. McPheeters PhD, MPH

12/30/2013
A Systematic Review of Validated Methods for Identifying Venous Thromboembolism using Administrative and Claims Data

Leo Tamariz MD, MPH; Thomas Harkins MA, MPH; Vinit Nair BPharm, MS, RPh

01/19/2012