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 ascending Authors Date Posted
When Should Case-Only Designs be used for Safety Monitoring of Medical Products?

Malcolm Maclure SM, SD; Bruce Fireman MA; Jennifer C. Nelson PhD; Wei Hua MD, PhD; Azadeh Shoaibi PhD, MHS, MS; Antonio Paredes PhD; David Madigan PhD

Validity of Diagnostic Codes to Identify Cases of Severe Acute Liver Injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database

Vincent Lo Re MD, MSCE; Kevin Haynes PharmD, MSCE; David Goldberg MD, MSCE; Kimberly L. Forde MD, MHS; Dena M. Carbonari MS; Kimberly B. F. Leidi MPH; Sean Hennessy PharmD, PhD; K. Rajender Reddy MD; Pamela A. Pawloski PharmD; Gregory W. Daniel PhD, MPH, RPh; Craig Cheetham PharmD, MS; Aarthi Iyer MPH; Kara O. Coughlin; Sengwee Toh ScD, Denise M. Boudreau RPh, PhD; Nandani Selvam PhD, MPH; William O. Cooper MD, MPH; Mano S. Selvan PhD; Jeffery J. VanWormer PhD; Mark I. Avigan MD, CM; Monika Houstoun PharmD; Gwen L. Zornberg MD, ScD, MS; Judith A. Racoosin MD, MPH; Azadeh Shoaibi PhD, MHS, MS

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

Validation of Anaphylaxis in the Food and Drug Administration's Mini-Sentinel

Kathleen Walsh MD, MSc; Sarah Cutrona MD, MPH; Sarah Foy BA; Meghan Baker MD, ScD; Susan Forrow BA; Azadeh Shoaibi PhD, MHS, MS; Pamala Pawloski PharmD; Michelle Conroy MD; Andrew Fine MD, MPH; Lise Nigrovic MD, MPH; Nandini Selvam PhD, MPH; Mano Selvan PhD; William Cooper MD, MPH; Susan Andrade ScD

Validation of Acute Myocardial Infarction in the Food and Drug Administration's Mini-Sentinel Program

Sarah L. Cutrona MD, MPH; Sengwee Toh ScD; Aarthi Iyer MPH; Sarah Foy BA; Gregory W. Daniel PhD, MPH; Vinit P. Nair BPharm, MS, RPh; Daniel Ng MD; Melissa G. Butler PharmD, MPH, PhD; Denise Boudreau RPh, PhD; Susan Forrow BA; Robert Goldberg PhD; Joel Gore MD; David McManus MD; Judith A. Racoosin MD, MPH; Jerry H. Gurwitz MD

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

Using High-Dimensional Propensity Scores to Automate Confounding Control in a Distributed Medical Product Safety Surveillance System

Jeremy A. Rassen ScD; Sebastian Schneeweiss MD, ScD 

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

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

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

Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis

Christian Hampp, Richard S. Swain, Casie Horgan, Elizabeth Dee, Yandong Qiang, Sarah K. Dutcher, Andrew Petrone, Rong Chen Tilney, Judith C. Maro, Catherine A. Panozzo

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

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

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

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 

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

The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product Safety

Melissa A. Robb RN; Judith A. Racoosin MD, MPH; Rachel E. Sherman MD, MPH, FACP; Thomas P. Gross MD; Robert Ball MD, MPH, ScM; Marsha E. Reichman PhD; Karen Midthun MD; Janet Woodcock MD, MPH

The U.S. Food and Drug Administration's Mini-Sentinel Program: Status and Direction

Richard Platt MD, MSc; Ryan M. Carnahan PharmD, MS, BCPP; Jeffrey S. Brown PhD; Elizabeth Chrischilles PhD, MS; Lesley H. Curtis PhD; Sean Hennessy PharmD, PhD; Jennifer C. Nelson PhD; Judith A. Racoosin MD, MPH; Melissa Robb RN; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD; Mark G. Weiner MD

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

The Organizational Structure and Governing Principles of the Food and Drug Administration's Mini-Sentinel Pilot Program

Susan Forrow BA; Daniel M. Campion MBA; Lisa J. Herrinton PhD; Vinit P. Nair BPharm, MS, RPh; Melissa A. Robb RN; Marcus Wilson PharmD; Richard Platt MD, MSc

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

The Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise

Michael Nguyen MD; Robert Ball MD, MPH, ScM; Karen Midthun MD; Tracy A. Lieu MD, MPH

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

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

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

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

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

Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance

Daniel A. Salmon PhD, MPH; W. Katherine Yih PhD, MPH; Grace Lee MD, MPH; Robert Rosofsky MA; Jeffrey Brown PhD; Kirsten Vannice PhD, MHS; Jerome Tokars MD, MPH; James Roddy; Robert Ball MD, MPH, ScM; Bruce Gellin MD, MPH; Nicole Lurie MD, MSPH; Howard Koh MD; Richard Platt MD, MSc; Tracy Lieu MD, MPH

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

Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot

Andrea J. Cook PhD; Ram C. Tiwari PhD; Robert D. Wellman MS; Susan R. Heckbert MD, PhD; Lingling Li, PhD; Patrick Heagerty PhD; Tracey Marsh MS; Jennifer C. Nelson PhD

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

Signal Identification Methods in the Sentinel System

Judith Maro

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

Sentinel System Five-Year Strategy: 2019-2023

U.S. Food and Drug Administration

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

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

Meijia Zhou, Sean Hennessy

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

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

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 

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

Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study

Judith C. Maro PhD; Dennis G. Fryback PhD; Tracy A. Lieu MD, MPH; Grace M. Lee MD, MPH; David B. Martin MD, MPH

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

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

Re-Using Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals via Modular Analytic Programs

Sengwee Toh ScD; Jerry Avorn MD; Ralph B. D'Agostino Sr. PhD; Jerry H. Gurwitz MD; Bruce M. Psaty MD, PhD; Kenneth J. Rothman DrPH; Kenneth G. Saag MD, MSc; Miriam C.J.M. Sturkenboom PhD; Jan P. Vandenbroucke MD, PhD; Almut G. Winterstein RPh, PhD; Brian L. Strom MD, MPH

Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program

Sengwee Toh ScD; Meghan A. Baker MD, ScD; Jeffrey S. Brown PhD; Cynthia Kornegay PhD; Richard Platt MD, MS

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

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

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

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

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

PRISM Supplement to Vaccine - Active Surveillance of Vaccine Safety in the US Food and Drug Administration’s Mini-Sentinel Program: Identification of Exposures and Outcomes

 Melissa L. McPheeters PhD, MPH; Ryan Carnahan PharmD, MS, BCPP

Postlicensure Rapid Immunization Safety Monitoring Program (PRISM) Data Characterization

Meghan A. Baker MD, ScD; Michael Nguyen MD; David Cole BM; Grace M. Lee MD, MPH; Tracy A. Lieu MD, MPH

Pharmacoepidemiology in the Era of Real-World Evidence

Sengwee Toh ScD

Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding

Mary Ross Southworth PharmD; Marsha E. Reichman PhD; Ellis F. Unger MD

PDUFA V Commitment: Sentinel Program Interim and Final Assessments 09/27/2017
PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program

 Richard Platt MD, MSc; Ryan M. Carnahan PharmD, MS, BCPP

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

Outpatient Influenza Antivirals in a Distributed Data Network for Influenza Surveillance

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

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

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

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

Multivariable Confounding Adjustment in Distributed Data Networks without Sharing of Patient-Level Data

Sengwee Toh ScD; Marsha E. Reichman PhD; Monika Houstoun PharmD; Xiao Ding PhD; Bruce H. Fireman MA; Eric Gravel; Mark Levenson PhD; Lingling Li PhD; Erick Moyneur; Azadeh Shoaibi PhD, MHS; Gwen Zornberg MD, MS, ScD; Sean Hennessy PharmD, PhD 

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 

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

Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative Data: Summary of Findings and Suggestions for Future Research

Ryan M. Carnahan PharmD, MS, BCPP

Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons Learned

Ryan M. Carnahan PharmD, MS, BCPP; Kevin G. Moores PharmD

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

Methods for Systematic Reviews of Administrative Database Studies Capturing Health Outcomes of Interest

Melissa L. McPheeters PhD, MPH; Nila Sathe MA, MLIS; Rebecca N. Jerome MLIS, MPH; Ryan Carnahan PharmD, MS, BCPP

Methods for Examining Data Quality in Healthcare Integrated Data Repositories

Vojtech Huser, Michael Kahn, and Jeffrey Brown

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

Sarah Dutcher, Judith C. Maro, David Martin

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

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

Is Size the Next Big Thing in Epidemiology?

Sengwee Toh ScD; Richard Platt MD, MSc

Investments in Infrastructure for Diverse Research Resources and the Health of the Public

Bruce M. Psaty MD, PhD; Eric B. Larson MD, MPH

Intussusception Risk after Rotavirus Vaccination in U.S. Infants

W. Katherine Yih PhD, MPH; Tracy A. Lieu MD, MPH; Martin Kulldorff PhD; David Martin MD, MPH; Cheryl McMahill-Walraven PhD, MSW; Richard Platt MD, MSc; Nandini Selvam PhD, MPH; Mano Selvan PhD; Grace M. Lee MD, MPH; Michael Nguyen MD