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
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

06/08/2019
Medical Product Safety: Ten Years of the U.S. Sentinel System

Sarah Dutcher, Judith C. Maro, David Martin

05/23/2019
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

05/20/2019
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

05/17/2019
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

05/02/2019
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

04/24/2019
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

03/06/2019
Evidence from Real-World Data Sentinel Initiative of U.S. FDA

Darren Toh

02/20/2019
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

02/14/2019
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

02/12/2019
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

02/08/2019
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

01/19/2019
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

01/15/2019
FDA Voices: The Future of FDA's Electronic Safety Surveillance

Scott Gottlieb and Gerald Dal Pan

01/09/2019
Sentinel System Five-Year Strategy: 2019-2023

U.S. Food and Drug Administration

01/09/2019
Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel

Danijela Stojanovic

11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10

Elizabeth Suarez

11/30/2018
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

11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App

David Martin

11/30/2018
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

11/29/2018
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

11/23/2018
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

11/19/2018
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
 

11/14/2018
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

11/13/2018
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

11/05/2018
A Generalizable Smartphone-Based Clinical Research Platform

Zachary Wyner

11/05/2018
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

10/31/2018
Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative

Judith C. Maro

10/19/2018
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

10/15/2018
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

10/01/2018
International Comparison of Approaches to Common Data Models for Comparative Effectiveness Research

Jeffrey Brown

09/12/2018
Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System

Robert Ball, Sengwee Toh, Jamie Nolan, Kevin Haynes, Richard Forshee, Taxiarchis Botsis

08/28/2018
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: 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 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: 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 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 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: 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 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 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: 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 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: 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 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: 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 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: 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 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
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
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

08/17/2018
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

08/10/2018
Data Enclaves for Sharing Information Derived From Clinical and Administrative Data

Richard Platt and Tracy Lieu

08/06/2018
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

08/01/2018
Outpatient Influenza Antivirals in a Distributed Data Network for Influenza Surveillance

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

07/27/2018
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

06/26/2018
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

06/26/2018
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 

06/26/2018
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 

06/22/2018
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

06/06/2018
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
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

05/21/2018
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

03/15/2018
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

03/13/2018
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

03/08/2018
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

03/05/2018
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

02/23/2018
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

02/22/2018
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

02/15/2018
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

01/31/2018
Butterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal Inference

Rima Izem PhD

01/12/2018
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

01/10/2018
Methods for Examining Data Quality in Healthcare Integrated Data Repositories

Vojtech Huser, Michael Kahn, and Jeffrey Brown

01/03/2018