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 descending
Developing the Sentinel System — A National Resource for Evidence Development

Rachel E. Behrman MD, MPH; Joshua S. Benner PharmD, ScD; Jeffrey S. Brown PhD; Mark McClellan MD, PhD; Janet Woodcock MD; Richard Platt MD, MSc

02/10/2011
Effects of Adjusting for Instrumental Variables on Bias and Precision of Effect Estimates

Jessica A. Myers PhD, ScD; Jeremy A. Rassen ScD; Joshua J. Gagne PharmD, MS; Krista F. Huybrechts PhD, MS; Sebastian Schneeweiss MD, ScD; Kenneth J. Rothman MPH, DrPH; Marshall M. Joffe MD, PhD, MPH; Robert J. Glynn PhD, ScD

06/08/2011
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 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
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

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 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 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 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 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 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 Ventricular Arrhythmias using Administrative and Claims Data

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

01/19/2012
Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel

Sarah L. Cutrona MD, MPH; Sengwee Toh ScD; Aarthi Iyer MPH; Sarah Foy BA; Elizabeth Cavagnaro MPH; Susan Forrow BA; Judith A. Racoosin MD, MPH; Robert Goldberg PhD; Jerry H. Gurwitz MD

01/19/2012
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

01/19/2012
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
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

01/19/2012
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
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

01/19/2012
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

01/19/2012
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 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
Design Considerations in an Active Medical Product Safety Monitoring System

Joshua J. Gagne PharmD, ScD; Bruce Fireman, MA; Patrick B. Ryan PhD; Malcolm Maclure SM, SD; Tobias Gerhard PhD; Sengwee Toh ScD; Jeremy A. Rassen ScD; Jennifer C. Nelson PhD; Sebastian Schneeweiss MD, ScD

01/19/2012
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

01/19/2012
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
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

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
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

02/05/2012
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 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
PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program

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

02/05/2012
Design Considerations, Architecture, and use of the Mini-Sentinel Distributed Data System

Jeffrey S. Brown PhD; Lesley H. Curtis PhD; Mark G. Weiner MD; Denise M. Boudreau RPh, PhD; William O. Cooper MD, MPH; Gregory W. Daniel PhD, MPH; Vinit P. Nair BPharm, MS, RPh; Marsha A. Raebel PharmD; Nicolas U. Beaulieu MA; Robert Rosofsky MA; Tiffany S. Woodworth MPH 

02/05/2012
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 Lymphoma using Administrative Data

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

02/05/2012
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 

02/05/2012
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 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
Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data

Jennifer C. Nelson PhD; Andrea J. Cook PhD; Onchee Yu MS; Clara Dominguez; Shanshan Zhao; Sharon K. Greene PhD, MPH; Bruce H. Fireman MA; Steven J. Jacobsen; Eric S. Weintraub; Lisa A. Jackson MD, MPH

02/05/2012
Health Outcomes of Interest for Evaluation in the Postlicensure Rapid Immunization Safety Monitoring Program

Tracy A. Lieu MD, MPH; Michael D. Nguyen MD; Robert Ball MD, MPH, ScM; David B. Martin MD, MPH

04/16/2012
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

06/29/2012
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

11/01/2012
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

11/12/2012
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

04/04/2013
Is Size the Next Big Thing in Epidemiology?

Sengwee Toh ScD; Richard Platt MD, MSc

05/01/2013
Investments in Infrastructure for Diverse Research Resources and the Health of the Public

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

05/08/2013
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

05/13/2013
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 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

06/25/2013
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
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 

07/22/2013
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

08/07/2013
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

09/05/2013
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

12/30/2013
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
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

12/30/2013
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

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

12/30/2013
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

12/30/2013
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
A Systematic Review of Validated Methods to Capture Several Rare Conditions using Administrative or Claims Data

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

12/30/2013
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

12/30/2013
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

12/30/2013
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

12/30/2013
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

12/30/2013
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, MS, BCPP; Melissa McPheeters PhD, MPH

12/30/2013
Framework for Assessment of Positive Results from Signal Refinement

David L. McClure PhD; Marsha A. Raebel PharmD; W. Katherine Yih PhD, MPH; Azadeh Shoaibi PhD, MHS, MS; Jerald E. Mullersman MD, PhD, MPH; Colin Anderson-Smits MPH; Jason M. Glanz PhD

01/01/2014
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

02/06/2014
Electronic Clinical Laboratory Test Results Data Tables: Lessons from Mini-Sentinel

Marsha A. Raebel PharmD; Kevin Haynes PharmD, MSCE; Tiffany S. Woodworth MPH; Gwyn Saylor; Elizabeth Cavagnaro MPH; Kara O. Coughlin; Lesley H. Curtis PhD; Mark G. Weiner MD; Patrick Archdeacon MD; Jeffrey S. Brown PhD

02/18/2014
Four Health Data Networks Illustrate The Potential For A Shared National Multipurpose Big-Data Network

Richard Platt MD, MSc; Lesley H. Curtis PhD; Jeffrey S. Brown PhD

07/01/2014
Characteristics of Study Design and Elements that may Contribute to the Success of Electronic Safety Monitoring Systems

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

09/28/2014
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; Tobias Gerhard PhD

10/06/2014
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

12/22/2014
A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program

Meghan A. Baker MD, ScD; Tracy A. Lieu MD, MPH; Lingling Li PhD; Wei Hua MD; Yandong Qiang MD, PhD, MPH; Alison Tse Kawai ScD; Bruce Fireman MA; David B. Martin MD, MPH; Michael Nguyen MD

03/12/2015
Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance

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

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

05/22/2015
Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin

Scott K. Winiecki MD; Bethany Baer MD; Wambui Chege MD; Christopher Jankosky MD; Paul D. Mintz MD; Meghan A. Baker MD, ScD; Tiffany S. Woodworth MPH; Michael D. Nguyen MD

07/14/2015
Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine

Alison Tse Kawai ScD; David Martin MD, MPH; Martin Kulldorff PhD; Lingling Li PhD; David V. Cole BM; Cheryl N. McMahill-Walraven PhD, MSW; Nandini Selvam PhD, MPH; Mano S. Selvan PhD; Grace M. Lee MD, MPH

09/14/2015
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

12/08/2015