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
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

08/10/2017
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

07/04/2017
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

06/12/2017
Antiemetic use among Pregnant Women in the United States: the Escalating use of Ondansetron

Lockwood G. Taylor PhD, MPH; Steven T. Bird PharmD, PhD, MS; Leyla Sahin MD; Melissa S. Tassinari PhD; Patty Greene PharmD; Marsha E. Reichman PhD; Susan E. Andrade ScD; Katherine Haffenreffer BS; Sengwee Toh ScD

02/20/2017
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 

01/06/2017
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

12/01/2016
Distributed Data Networks: A Blueprint for Big Data Sharing and Healthcare Analytics

Jennifer R. Popovic DVM, MA

11/18/2016
The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies

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

11/14/2016
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
2016 ICPE Poster: Pilot Test of the Sentinel Modular Program for Propensity Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Severe Hypoglycemia

Meijia Zhou, Shirley V. Wang, Charles E. Leonard, Joshua J. Gagne, Candace Fuller, Christian Hampp, Patrick Archdeacon, Sengwee Toh, Aarthi Iyer, Tiffany Siu Woodworth, Elizabeth Cavagnaro, Catherine A. Panozzo, Sophia Axtman, Ryan M. Carnahan, Elizabeth A. Chrischilles, Sean Hennessey

08/26/2016
2016 ICPE Presentation: Monitoring All Drugs for a Specific Outcome in the Sentinel System

Judith C. Maro, Gerald Dal Pan, Jeffrey S. Brown, Inna Dashevsky, Martin Kulldorff

08/25/2016
2016 ICPE Presentation: Assessing Quadrivalent HPV Vaccine Safety using the Self-Controlled Tree-Temporal Scan Statistic

Martin Kulldorff, Katherine Yih

08/25/2016
2016 ICPE Poster: A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems

Steven T. Bird, Kate Gelperin, Lockwod Taylor, Leyla Sahin, Mohamed Mohamoud, Christian Hampp

08/25/2016
2016 ICPE Poster: Utilization of Laboratory Results Data to Enhance Pregnancy Cohort Identification in a Distributed Data Network

Kevin Haynes, Andrew Sterrett, Susan M. Shetterly, Mano S. Selvan, Joshua J. Gagne, Christine Y. Lu, Azadeh Shoaibi, Marsha A. Raebel

08/25/2016
2016 ICPE Poster: Do Hemoglobin Lab Test Results Increase Detection of Upper Gastrointestinal Bleeding (UGIB)?

Elisabetta Patorno, Joshua J. Gagne, Christine Y. Lu, Kevin Haynes, Andrew T. Sterrett, Jason Roy, Xingmei Wang, Marsha A. Raebel

08/25/2016
2016 ICPE Poster: Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA's Sentinel Program

John G. Connolly, Joshua J. Gagne

08/25/2016
2016 ICPE Poster: A Framework for Rapid Medical Product Safety Assessment: FDA's Sentinel Toolkit

Elizabeth Cavagnaro, Hannah Katcoff, Candace Fuller, Jennifer R. Popovic, Tiffany S. Woodworth, Nicolas Beaulieu, April Duddy, Eric Gravel, Erick Moyneur, Sengwee Toh, Jeffrey Brown

08/25/2016
2016 ICPE Symposium: ICD-10-CM: Is Sentinel Ready?

Darren Toh

08/25/2016
2016 ICPE Presentation: Assessment of the US Food and Drug Administration’s Sentinel Analysis Tools: Angiotensin-Converting Enzyme Inhibitors and Angioedema

Joshua Gagne

08/25/2016
2016 ICPE Presentation: Ondasetron Use Among Pregnancies Identified in the Sentinel Distributed Database

Lockwood G. Taylor

08/25/2016
2016 ICPE Presentation: Utilization Patterns for Products with Pregnancy Exposure Registries in Pregnant Versus Non-Pregnant Women in the Sentinel Database

Steven T. Bird, Lockwood Taylor, Christian Hampp, Kate Gelperin, Darren Toh, Susan Andrade, Katie Haffenreffer, Marsha Reichman, Leyla Sahin

08/25/2016
2016 ICPE Presentation: Diagnosis-Based Cohort Augmentation Using Laboratory (Lab) Data in the FDA Sentinel Initiative: The Case of Chronic Kidney Disease (CKD)

David H. Smith

08/25/2016
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

08/22/2016
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

08/01/2016
Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association

Susan Gruber PhD, MPH; Aloka Chakravarty PhD; Susan R. Heckbert MD, PhD; Mark S. Levenson PhD; David Martin MD, MPH; Jennifer C. Nelson PhD; Bruce M. Psaty MD, PhD; Simone Pinheiro ScD, MSc; Christian G. Reich MD, PhD; Sengwee Toh ScD; Alexander M. Walker MD, PhD

07/14/2016
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

06/10/2016
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 

06/07/2016
Evidence Generation from Healthcare Databases: Recommendations for Managing Change

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

05/17/2016
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 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

05/13/2016
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

05/04/2016
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

05/04/2016
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

05/01/2016
Intravenous Immune Globulin and Thromboembolic Adverse Events: A Systematic Review and Meta-Analysis of RCTs

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

04/24/2016
Changing Patterns of Asthma Medication use Related to U.S. Food and Drug Administration Long-Acting Beta2-agonist Regulation from 2005-2011

Melissa G. Butler PharmD, PhD, MPH; 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

03/01/2016
Evaluation of Propensity Scores, Disease Risk Scores, and Regression in Confounder Adjustment for the Safety of Emerging Treatment with Group Sequential Monitoring

Stanley Xu PhD; Susan Shetterly MS; Andrea J. Cook PhD; Marsha A. Raebel PharmD; Sunali Goonesekera MS; Azadeh Shoaibi PhD, MS, MHS; Jason Roy PhD; Bruce Fireman MA

02/15/2016
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 PhD; Martijn Schuemie PhD; Jeffrey Brown PhD; Patrick Ryan PhD; Edoardo Vacchi PhD; Massimo Coppola; Walter Cazzola PhD; Preciosa Coloma MD, PhD; Roberto Berni; Gayo Diallo PhD; José Luis Oliveira PhD; Paul Avillach MD, PhD; Gianluca Trifirò MD, PhD; Peter Rijnbeek PhD, MSc; Mariadonata Bellentani; Johan van Der Lei MD, PhD; Niek Klazinga MD, PhD; Miriam Sturkenboom PhD, MS

02/08/2016
Improving Therapeutic Effectiveness and Safety through Big Healthcare Data

Sebastian Schneeweiss MD, ScD

01/17/2016
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

01/12/2016
Evaluation of the Risk of Venous Thromboembolism after Quadrivalent Human Papillomavirus Vaccination among U.S. Females

W. Katherine Yih PhD, MPH; Sharon K. Greene PhD, MPH; Lauren Zichittella MS; Martin Kulldorff PhD; Meghan A. Baker MD, ScD; Jill L.O. de Jong MD, PhD; Ruth Gil Prieto PhD, MPH, MSc; Marie R. Griffin MD, MPH; Robert Jin MS; Nancy D. Lin ScD; Cheryl McMahill-Walraven PhD, MSW; Megan Reidy MPH; Nandini Selvam; PhD, MPH; Mano Selvan PhD; Michael D. Nguyen MD

01/02/2016
Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011

Allison L. Naleway PhD; Brad Cranea; Ning Smith; Matthew F. Daley MD; James Donahue; Julianne Gee Sharon K. Greene PhD, MPH; Theresa Harrington; Lisa A. Jackson MD, MPH; Nicola P. Klein MD, PhD; Hung Fu Tseng; Claudia Vellozzi MD; Eric S. Weintraub

 

01/02/2016
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; Richard Platt MD, MSc; Brooke Courtney JD, MPH; Marsha E. Reichman PhD

01/01/2016
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
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
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
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
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

03/13/2015
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
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
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
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
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
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
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
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
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
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
2013 ICPE Presentation: Self-Control Tree Scan Data Mining for Vaccine Adverse Events

Martin Kulldorf, Carolyn Balsbaugh, Inna Dashevsky, Ruth Gil-Prieto, Grace Lee, Michael Nguyen, David Martin, Estelle Russek-Cohen, Robert Ball, Robert Davis

08/28/2013
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
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
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
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
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
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
Is Size the Next Big Thing in Epidemiology?

Sengwee Toh ScD; Richard Platt MD, MSc

05/01/2013