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
Antiemetic use among pregnant women in the United States: the escalating use of ondansetron

Lockwood G. Taylor, Steven T. Bird, Leyla Sahin, Melissa S. Tassinari, Patty Greene, Marsha E. Reichman, Susan E. Andrade, Katherine Haffenreffer, Sengwee Toh

2/21/2017
Use of Electronic Health Data to Estimate Heart Failure Events in a Population-Based Cohort with CKD

James S. Floyd, Robert Wellman, Sharon Fuller, Nisha Bansal, Bruce M. Psaty, Ian H. de Boer, Delia Scholes

1/19/2017
Missing laboratory results data in electronic health databases: implications for monitoring diabetes risk

Flory JH, Roy J, Gagne JJ, Haynes K, Herrinton L, Lu C, Patorno E, Shoaibi A, Raebel MA

1/6/2017
Sentinel Program Interim Assessment (FY 15)

U.S. Food & Drug Administration

12/1/2016
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; Ricahrd Platt, MD, MSc; Brooke Courtney, JD, MPH; Marsha E. Reichman, PhD

12/1/2016
Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System

Katherine Yih, PhD, MPH; Martin Kulldorff, PhD; Sukhminder K. Sandhu, PhD, MPH, MS; Lauren Zichittella, MS; Judith C. Maro, PhD, MS; David V. Cole; 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

Katherine Yih, PhD, MPH; Martin Kulldorff, PhD; Sukhminder K. Sandhu, PhD, MPH, MS; Lauren Zichittella, MS; Judith C. Maro, PhD, MS; David V. Cole; 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

11/30/2016
Distributed data networks: a blueprint for Big Data sharing and healthcare analytics

Jennifer R. Popovic 

11/17/2016
The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies

Patorno E, Gagne JJ, Lu CY, Haynes K, Sterrett AT, Roy J, Wang X, Raebel MA.

11/14/2016
Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making

S Schneeweiss, H-G Eichler, A Garcia-Altes, C Chinn, A-V Eggimann, S Garner, W Goettsch, R Lim, W Löbker, D Martin, T Müller, BJ Park, R Platt, S Priddy, M Ruhl, A Spooner, B Vannieuwenhuyse, RJ Willke

10/19/2016
A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data.

Nelson JC, Wellman R, Yu O, Cook AJ, Maro JC, Ouellet-Hellstrom R, Boudreau D, Floyd JS, Heckbert S , Pinheiro S, Reichman M, Shoaibi A 

9/5/2016
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

JJ Gagne, X Han, S Hennessy, CE Leonard, EA Chrischilles, RM Carnahan, SV Wang, C Fuller, A Iyer, H Katcoff, TS Woodworth, P Archdeacon, TE Meyer, S Schneeweiss, S Toh

8/21/2016
Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug–outcome association

Susan Gruber, Aloka Chakravarty, Susan R. Heckbert, Mark Levenson, David Martin, Jennifer C. Nelson, Bruce M. Psaty, Simone Pinheiro, Christian G. Reich, Sengwee Toh, Alexander M. Walker

7/14/2016
Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study

Toh S, Hampp C, Reichman ME, Graham DJ, Balakrishnan S, Pucino F, Hamilton J, Lendle S, Iyer A, Rucker M, Pimentel M, Nathwani N, Griffin MR, Brown NJ, Fireman BH

6/7/2016
Evidence generation from healthcare databases: recommendations for managing change

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

5/17/2016
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, Marsha E. Reichman, Katrina Mott, Marilyn Pitts, Caren Kieswetter, Miriam Dinatale, Marc B. Stone, Jennifer Popovic, Katherine Haffenreffer, Sengwee Toh

5/12/2016
Uptake of new drugs in the early post-approval period in the Mini-Sentinel distributed database.

Mott K, Graham DJ, Toh S, Gagne JJ, Levenson M, Ma Y, Reichman ME.

 

5/3/2016
Methods for using clinical laboratory test results as baseline confounders in multi-site observational database studies when missing data are expected

Raebel MA, Shetterly S, Lu CY, Flory J, Gagne JJ, Harrell FE, Haynes K, Herrinton LJ, Patorno E, Popovic J, Selvan M, Shoaibi A, Wang X, Roy J

5/3/2016
Intravenous immune globulin and thromboembolic adverse events: A systematic review and meta-analysis of RCTs

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

4/24/2016
Quantitative Bias Analysis in Regulatory Settings

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

3/17/2016
Changing patterns of asthma medication use related to US Food and Drug Administration long-acting β2-agonist regulation from 2005-2011

Melissa G. Butler, PharmD, MPH, PhD, 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

3/1/2016
Evaluation of propensity scores, disease risk scores, and regression in confounder adjustment for the safety of emerging treatment with group sequential monitoring

Stanley Xu, Susan Shetterly, Andrea J. Cook, Marsha A. Raebel, Sunali Goonesekera, Azadeh Shoaibi, Jason Roy, Bruce Fireman

2/15/2016
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, Martijn Schuemie, Jeffrey Brown, Patrick Ryan, Edoardo Vacchi, Massimo Coppola, Walter Cazzola, Preciosa Coloma, Roberto Berni, Gayo Diallo, José Luis Oliveira, Paul Avillach, Gianluca Trifirò, Peter Rijnbeek, Mariadonata Bellentani, Johan van Der Lei, Niek Klazinga, and Miriam Sturkenboom

2/8/2016
The FDA's sentinel initiative—A comprehensive approach to medical product surveillance

Robert Ball, Melissa A. Robb, Stephen A. Anderson, Gerald Dal Pan

2/1/2016
Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program

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

1/31/2016
Improving therapeutic effectiveness and safety through big healthcare data

S Schneeweiss

1/17/2016
Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females

Yih WK, Greene SK, Zichittella L, Kulldorff M, Baker MA, de Jong JL, Gil-Prieto R, Griffin MR, Jin R, Lin ND, McMahill-Walraven CN, Reidy M, Selvam N, Selvan MS, Nguyen MD

1/2/2016
Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008–2011

Allison L. Naleway, Brad Cranea, Ning Smith, Matthew F. Daley, James Donahue, Julianne Gee, Sharon K. Greene, Theresa Harrington, Lisa A. Jackson, Nicola P. Klein, Hung Fu Tseng, Claudia Vellozzi, Eric S. Weintraub, for the Vaccine Safety Datalink

1/2/2016
Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine

Alison Tse Kawai, David Martin, Martin Kulldorff, Lingling Li, David V. Cole, Cheryl N. McMahill-Walraven, Nandini Selvam, Mano S. Selvan, Grace M. Lee

9/13/2015
Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin

Scott Winiecki, Bethany Baer, Wambui Chege, Christopher Jankosky, Paul Mintz, Meghan Baker, Tiffany Woodworth, Michael Nguyen

7/14/2015
Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance

Ivair R Silva, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA and Department of Statistics, Universidade Federal de Ouro Preto, Ouro Preto, Minas Gerais, Brazil

Martin Kulldorff, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, M

5/26/2015
A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program

Meghan A. Baker, Tracy A. Lieu, Lingling Li, Wei Hua, Yandong Qiang, Alison Tse Kawai, Bruce H. Fireman, David B. Martin, Michael D. Nguyen

3/12/2015
Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study

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

1/4/2015
Adherence to Guidelines for Glucose Assessment in Starting Second-Generation Antipsychotics

Marsha Raebel, PharmD, Robert Penfold, PhD, Ann McMahon, MD, MSc, Marsha Reichman, PhD, Susan Shetterly, MS, Glenn Goodrich, MS, Susan Andrade, ScD, Christoph Correll, MD, and Tobias Gerhard, PhD

10/5/2014
Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems

Carlos Bell, Aloka Chakravarty, Susan Gruber, Susan R. Heckbert, Mark Levenson, David Martin, Jennifer C. Nelson, Simone Pinheiro, Bruce M. Psaty, Christian G. Reich, Sebastian Schneeweiss, Azadeh Shoaibi, Sengwee Toh and Alexander M. Walker

9/29/2014
Four Health Data Networks Illustrate The Potential For A Shared National Multipurpose Big-Data Network

Lesley H. Curtis, Jeffrey S. Brown, Richard Platt

7/18/2014
Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel

Marsha A. Raebel, Kevin Haynes, Tiffany S. Woodworth, Gwyn Saylor, Elizabeth Cavagnaro, Kara O. Coughlin, Lesley H. Curtis, Mark G. Weiner, Patrick Archdeacon and Jeffrey S. Brown

2/18/2014
Intussusception Risk after Rotavirus Vaccination in U.S. Infants

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

1/13/2014
Framework for assessment of positive results from signal refinement

David L. McClure, Marsha A. Raebel, W. Katherine Yih, Azadeh Shoaibi, Jerald E. Mullersman, Colin Anderson-Smits, and Jason M. Glanz

1/7/2014
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 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 to capture acute bronchospasm using administrative or claims data

Mona Sharifi, MD, MPH, Shanthi Krishnaswami, MMS, Melissa L. McPheeters, PhD, MPH

12/30/2013
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

12/29/2013
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

Edited by: Melissa L. McPheeters, PhD, MPH, and Ryan Carnahan, PharmD, MS, BCPP

12/29/2013
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

12/29/2013
A systematic review of validated methods to capture several rare conditions using administrative or claims data

Christopher D. Lee, S. Elizabeth Williams, MD, Nila A. Sathe, MA, MLIS, Melissa L. McPheeters, PhD, MPH

12/29/2013
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

12/29/2013
A systematic review of validated methods to capture myopericarditis using administrative or claims data

Rachel T. Idowu, MD, Ryan Carnahan, PharmD, MS, BCPP, Nila Sathe, MA, MLIS, Melissa L. McPheeters, PhD, MPH

12/29/2013
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

12/29/2013
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

12/29/2013
A systematic review of validated methods to capture stillbirth and spontaneous abortion using administrative or claims data

Frances E. Likis, DrPH, NP, CNM, Nila Sathe, MA, MLIS, Ryan Carnahan, PharmD, M.S., BCPP, Melissa McPheeters PhD, MPH

12/29/2013
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

12/29/2013
Validation of anaphylaxis in the Food and Drug Administration's Mini-Sentinel

Kathleen Walsh, Sarah Cutrona, Sarah Foy, Meghan Baker, Susan Forrow, Azadeh Shoaibi, Pamala Pawloski, Michelle Conroy, Andrew Fine, Lise Nigrovic, Nandini Selvam, Mano Selvan, William Cooper, and Susan Andrade

9/5/2013
Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs

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

8/7/2013
Multivariable confounding adjustment in distributed data networks without sharing of patient-level data

Sengwee Toh, Marsha E. Reichman, Monika Houstoun, Xiao Ding, Bruce H. Fireman, Eric Gravel, Mark Levenson, Lingling Li, Erick Moyneur, Azadeh Shoaibi, Gwen Zornberg, Sean Hennessy

7/22/2013
A critical review of methods to evaluate the impact of FDA regulatory actions

Becky A. Briesacher, Stephen B. Soumerai, Fang Zhang, Sengwee Toh, Susan E. Andrade, Joann L. Wagner, Azadeh Shoaibi, Jerry H. Gurwitz

7/12/2013
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, Kevin Haynes, David Goldberg, Kimberly L. Forde, Deena M. Carbonari, Kimberly B. F. Leidi, Sean Hennessy, K. Rajender Reddy, Pamela A. Pawloski, Gregory W. Daniel, t. Craig Cheetham, Aarthi Iyer, Kara O. Coughlin, Sengwee Toh, Denise M. Boudreau, Nandani Selvam, William O. Cooper, Mano S. Selvan, Jeffery J. VanWormer, Mark I. Avigan, Monika Houstoun, Gwen L. Zornberg, Judith A. Racoosin, and Azadeh Shoaibi

6/28/2013
Investments in Infrastructure for Diverse Research Resources and the Health of the Public

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

5/8/2013
Is size the next big thing in epidemiology?

Sengwee Toh, ScD; Richard Platt, MD, MS

4/3/2013
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; for the Mini-Sentinel Investigators

3/22/2013
Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding

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

3/12/2013
Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance

Daniel Salmon, W. Katherine Yih, Grace Lee, Robert Rosofsky, Jeffrey Brown, Kirsten Vannice, Jerome Tokars, James Roddy, Robert Ball, Bruce Gellin, Nicole Lurie, Howard Koh, Richard Platt, Tracy Lieu, and the PRISM Program Group

11/29/2012
Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Sengwee Toh, ScD; Marsha E. Reichman, PhD; Monika Houstoun, PharmD; Mary Ross Southworth, PharmD; Xiao Ding, PhD; Adrian F. Hernandez, MD; Mark Levenson, PhD; Lingling Li, PhD; Carolyn McCloskey, MD, MPH; Azadeh Shoaibi, MS, MHS; Eileen Wu, PharmD; Gwen Zornberg, MD, MS, ScD; Sean Hennessy, PharmD, PhD

10/21/2012
Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program

Sarah L. Cutrona, Sengwee Toh, Aarthi Iyer, Sarah Foy, Gregory W. Daniel, Vinit P. Nair, Daniel Ng, Melissa G. Butler, Denise Boudreau, Susan Forrow, Robert Goldberg, Joel Gore, David McManus, Judith A. Racoosin, Jerry H. Gurwitz

6/29/2012
Health Outcomes of Interest for Evaluation in the Postlicensure Rapid Immunization Safety Monitoring Program

Tracy A. Lieu, Michael D. Nguyen, Robert Ball, David B. Martin

4/15/2012
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

2/6/2012
A systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data

Natalie Jones, Gary Schneider, Sumesh Kachroo, Philip Rotella, Ruzan Avetisyan, Matthew W. Reynolds

2/6/2012
A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data

Susan E. Andrade, Leslie R. Harrold, Jennifer Tjia, Sarah L. Cutrona, Jane S. Saczynski, Katherine S. Dodd, Robert J. Goldberg, Jerry H. Gurwitz

2/6/2012
A systematic review of validated methods for identifying acute respiratory failure using administrative and claims data

Natalie Jones, Gary Schneider, Sumesh Kachroo, Philip Rotella, Ruzan Avetisyan, Matthew W. Reynolds

2/6/2012
A systematic review of validated methods for identifying heart failure using administrative data

Jane S. Saczynski, Susan E. Andrade, Leslie R. Harrold, Jennifer Tjia, Sarah L. Cutrona, Katherine S. Dodd, Robert J. Goldberg, Jerry H. Gurwitz

2/6/2012
A systematic review of validated methods for identifying orthopedic implant removal and revision using administrative data

Jasvinder A Singh, Joseph A Kundukulam, Mohit Bhandari

2/6/2012
A systematic review of validated methods for identifying atrial fibrillation using administrative data

Paul N. Jensen, Karin Johnson, James Floyd, Susan R. Heckbert, Ryan Carnahan, Sascha Dublin

2/6/2012
The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction

Richard Platt, Ryan M. Carnahan, Jeffrey S. Brown, Elizabeth Chrischilles, Lesley H. Curtis, Sean Hennessy, Jennifer C. Nelson, Judith A. Racoosin, Melissa Robb, Sebastian Schneeweiss, Sengwee Toh, Mark G. Weiner

2/6/2012
A systematic review of validated methods for identifying venous thromboembolism using administrative and claims data

Leonardo Tamariz, Thomas Harkins, Vinit Nair

2/6/2012
The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Melissa A. Robb, Judith A. Racoosin, Rachel E. Sherman, Thomas P. Gross, Robert Ball, Marsha E. Reichman, Karen Midthun, Janet Woodcock

2/6/2012
A systematic review of validated methods for identifying depression using administrative data

Lisa Townsend, James T Walkup, Stephen Crystal, Mark Olfson

2/6/2012