Publications & 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 in conference materials.

Search Publications & Presentations

Title Type Peer or Non-Peer Reviewed Author(s) Date
2020 ICPE Presentation: Natural History of Coagulopathy in Patients with COVID-19 in a Real-World Electronic Health Data Network
Presentation
Presentation
Maria Kempner, Mayura Shinde, Joshua Hartman, Jennifer Lyons, Joy Kolonoski, Danijela Stojanovic, Brian Kit
11/06/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator: Descriptive Assessment of Coagulopathy Among COVID-19 Patients: Feasibility Data Review
Presentation
Presentation
Noelle Cocoros
10/28/2020
Natural History of Coagulopathy in COVID-19
Presentation
Presentation 10/26/2020
Leveraging the Capabilities of the FDA’s Sentinel System To Improve Kidney Care
Publication
Publication
Sruthi Adimadhyam, Erin F. Barreto, Noelle M. Cocoros, Sengwee Toh, Jeffrey S. Brown, Judith C. Maro, Jacqueline Corrigan-Curay, Gerald J. Dal Pan, Robert Ball, David Martin, Michael Nguyen, Richard Platt, Xiaojuan Li
10/19/2020
2020 ICPE Symposia: When Decisions Can't Wait: Delivering Rapid Real World Studies
Presentation
Presentation
Judith C. Maro, Simone Pinheiro
10/14/2020
Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis
Publication
Publication
Mohamed Mohamoud, Casie Horgan, Efe Eworuke, Elizabeth Dee, Justin Bohn, Oren Shapira, Monica A. Munoz, Danijela Stojanovic, Veronica Sansing‐Foster, Adebola Ajao, Lois La Grenade
10/08/2020
Phosphodiesterase Type 5 Inhibitor Use Among Pregnant and Reproductive‐Age Women in the United States
Publication
Publication
Wei Liu, Talia J. Menzin, Corinne M. Woods, Nicole R. Haug, Jie Li, Justin A. Mathew, Christine P. Nguyen, Grace P. Chai, David G. Moeny, Mayura Shinde
10/05/2020
Risk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin
Publication
Publication
Marie Bradley, Emily C. Welch, Efe Eworuke, David J. Graham, Rongmei Zhang, Ting-Ying Huang
09/28/2020
2020 ICPE Poster: Utilization of Spironolactone in Patients with Reduced or Preserved Ejection Fraction Heart Failure
Presentation
Presentation
Sruthi Adimadhyam, Austin Cosgrove, Qoua Her, Jennifer G. Lyons, Dave Martin, Efe Eworuke
09/24/2020
2020 ICPE Poster: Utilization of Sacubitril/​Valsartan in Real-World Settings
Presentation
Presentation
Efe Eworuke, Talia J. Menzin, Joy Kolonoski, Ting-Ying Huang
09/24/2020
2020 ICPE Presentation: Risk of Neuropsychiatric Adverse Events among Montelukast Users
Presentation
Presentation
Efe Eworuke, Nicole Haug, Andrew Mosholder, Noelle M. Cocoros, Marie Bradley, Yong Ma, Dinci Pennap, Elizabeth C. Dee, Sengwee Toh, Ella Pestine, Andrew B. Petrone, Ivone Kim, Jennifer G. Lyons, Veronica V. Sansing-Foster
09/24/2020
2020 ICPE Presentation: Comparative Risk Assessment of Severe Abnormal Uterine Bleeding associated with Non-Vitamin K Oral Anticoagulants
Presentation
Presentation
Efe Eworuke, Laura Hou, Rongmei Zhang, Hui-Lee Wong, Peter Waldron, Abby Anderson, Audrey Gassman, David Moeny, Ting-Ying Huang
09/23/2020
2020 ICPE Poster: Replicating the Findings of a Medicare Study on Stroke, and Bleeding Risk in Patients Using NOACs for Atrial Fibrillation in the Sentinel System
Presentation
Presentation
Marie Bradley, Emily C. Welch, Mayura Shinde, Efe Eworuke, Rongmei Zhang, Elande Baro, David J. Graham
09/23/2020
2020 ICPE Presentation: Use of Hydroxyprogesterone Caproate and Progesterone During the 2nd and/​or 3rd Trimester Among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database
Presentation
Presentation
Huei-Ting Tsai
09/23/2020
2020 ICPE Poster: Utilization Characteristics for Inhaled Corticosteroid‐based Asthma Medications in the Sentinel System, 2008‐2019
Presentation
Presentation
Tancy C. Zhang, Inna Dashevsky, Yan Li, Marie Bradley, Jianmeng Chen, Stacy Chin, Sandra DeLuccia, Efe Eworuke, Judith C. Maro, Yunzhao Ren, Rongmei Zhang, Chandrahas Sahajwalla, David Martin, Sally Seymour, Kenneth Quinto, Robert Busch, Catherine A. Panozzo
09/23/2020
2020 ICPE Poster: Factors Related to Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) and Dipeptidyl Peptidase 4 Inhibitor (DPP4i) Dispensing among Naive, Incident, and Prevalent New Users
Presentation
Presentation
Yandong Qiang, Casie E. Horgan, Andrew B Petrone, Joy Kolonoski, Aaron Hansbury, Christian Hampp, Sarah Dutcher, Sruthi Adimadhyam, Sengwee Toh
09/22/2020
2020 ICPE Poster: Assessing the Feasibility of Evaluating Tacrolimus Use after Solid Organ Transplantation in the Sentinel Distributed Database
Presentation
Presentation
Mingfeng Zhang, Sarah Dutcher, Monique Falconer, Nicole Haug, Lockwood Taylor, Andrew Petrone, Sheryl Kluberg, Justin Bohn
09/22/2020
2020 ICPE Presentation: Risk of Non-Melanoma Skin Cancer Associated with Hydrochlorothiazide-Containing Products in the United States
Presentation
Presentation
Efe Eworuke, Nicole Haug, Marie Bradley, Austin Cosgrove, Tancy Zhang, Elizabeth C. Dee, Sruthi Adimadhyam, Andrew Petrone, Hana Lee, Tiffany Siu Woodworth, Sengwee Toh
09/22/2020
2020 ICPE Poster: Incidence of Severe Abnormal Uterine Bleeding Following Oral Anticoagulant Use
Presentation
Presentation
Ting-Ying Huang, Laura Hou, Abby Anderson, Hui-Lee Wong, Rongmei Zhang, Peter Waldron, David Moeny, Audrey Gassman, Efe Eworuke
09/22/2020
2020 ICPE Poster: Utilization of IV Iron among Pregnant Women with Live Births or Stillbirths; A Study in the Sentinel Distributed Database
Presentation
Presentation
Steven T. Bird, Nicole Haug, Richard S. Swain, Leyla Sahin, Kate Gelperin, Joy Kolonoski, Justin Bohn, Mayura Shinde
09/21/2020
2020 ICPE Poster: Antipsychotic Medication Use among Hospitalized Infants Using Inpatient Data in FDA’s Sentinel System
Presentation
Presentation
Mayura Shinde, Candace C. Fuller, Rong Tilney, Austin Cosgrove, Jason Hickok, Russell Poland, Karla M. Miller, Crystal Garcia, Corinne Woods, Andrew Mosholder
09/21/2020
2020 ICPE Poster: Risk of Stroke and Bleeding in Nonvalvular Atrial Fibrillation Treated with Apixaban Compared to Warfarin in the Sentinel System
Presentation
Presentation
Marie C. Bradley, Emily C. Welch, Efe Eworuke, David J. Graham, Rongmei Zhang, Ting-Ying Huang
09/21/2020
2020 ICPE Poster: Incidence of Cutaneous Small Vessel Vasculitis associated with Oral Anticoagulant Use
Presentation
Presentation
Adebola Ajao, Oren Shapira, Efe Eworuke, Mohamed Mohamoud, Rongmei Zhang, Joy Kolonoski, John Connolly
09/21/2020
2020 ICPE Presentation: Comparing Three Signal Identification Methods with Self-Controlled Designs
Presentation
Presentation
Judith C. Maro, Shirley Wang, Inna Dashevsky, Joshua Gagne, Sandra DeLuccia, Jesper Hallas, G.Niklas Norén, Martin Kulldorff, Sai Dharmarajan, Esther Zhou, Elande Baro, Monica Munoz, Danijela Stojanovic, Michael Nguyen
09/18/2020
2020 ICPE Presentation: Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System
Presentation
Presentation
Susan E. Andrade
09/18/2020
2020 ICPE Poster: Asthma Maintenance Medication Users in the Sentinel System
Presentation
Presentation
Marie Bradley, Elnara Fazio-Eynullayeva, Sandra DeLuccia, Katherine Freitas, Judith C. Maro, Catherine A. Panozzo, Efe Eworuke, Rongmei Zhang, David Martin, Sally Seymour, Kenneth Quinto, Robert Busch, Yan Li, Jianmeng Chen, Stacy Chin, Yunzhao Ren, Chandrahas Sahajwalla
09/18/2020
2020 ICPE Poster: Percutaneous Transluminal Septal Myocardial Ablation and Common Procedural Complications: A Descriptive Study
Presentation
Presentation
John G. Connolly, Laura Hou, Justin Bohn, Talia Menzin, Jane Huang, Fortunato Senatore, Efe Eworuke, Marie Bradley
09/18/2020
2020 ICPE Presentation: Replication of Protocol-Based Analyses of Saxagliptin and Sitagliptin using Sentinel Modular Programs
Presentation
Presentation
Christian Hampp, Sheryl Kluberg, Laura Hou, Sengwee Toh, David Graham, Rongmei Zhang, Yandong Qiang, Justin Bohn
09/18/2020
2020 ICPE Poster: Incidence of Ocular Adverse Events Associated with Mometasone Implants among Patients with Nasal Polyposis
Presentation
Presentation
Efe Eworuke, Emmanuel Ojo, Miya Paterniti, Emily Welch, Mayura Shinde
09/18/2020
2020 ICPE Poster: Improving Identification of Anaphylaxis
Presentation
Presentation
James S. Floyd, David S. Carrell, Maralyssa A. Bann, Susan Gruber, Ron L. Johnson, Vina F. Graham, Cosmin A. Bejan, Mayura Shinde, Jennifer C. Nelson, Yong Ma, Robert Ball
09/18/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator: Assessing Data Source Characteristics in Multi-site Analyses
Presentation
Presentation 09/09/2020
Utilization of Sacubitril/​Valsartan in Real-World Settings
Publication
Publication
Efe Eworuke, Talia J. Menzin, Emily C. Welch, Joy Kolonoski, Ting-Ying Huang
08/25/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator: Defining COVID-19 Cohorts in Real-World Data
Presentation
Presentation
Noelle Cocoros, Judith C. Maro, Jeff Brown
08/19/2020
Risk of Psychiatric Adverse Events among Montelukast Users
Publication
Publication
Veronica V. Sansing-Foster, Nicole Haug, Andrew Mosholder, Noelle M. Cocoros, Marie Bradley, Yong Ma, Dinci Pennap, Elizabeth C. Dee, Sengwee Toh, Ella Pestine, Andrew B. Petrone, Ivone Kim, Jennifer G. Lyons, Efe Eworuke
08/10/2020
Consequences of Depletion of Susceptibles for Hazard Ratio Estimators Based on Propensity Scores
Publication
Publication
Bruce Fireman, Susan Gruber, Zilu Zhang, Robert Wellman, Jennifer Clark Nelson, Jessica Franklin, Judith C. Maro, Catherine Rogers Murray, Sengwee Toh, Joshua Gagne, Sebastian Schneeweiss, Laura Amsden, Richard Wyss
08/06/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator: Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Focus on Endpoints
Presentation
Presentation 08/05/2020
Underuse of Oral anticoagulants in privately insured patients with atrial fibrillation: A population targeted by IMplementation of a randomized controlled trial to ImProve treatment with Oral AntiCoagulanTs in atrial fibrillation patients (IMPACT-AFib)
Publication
Publication
Sana M. Al-Khatib, Sean D. Pokorney, Hussein R. Al-Khalidi, Kevin Haynes, Crystal Garcia, David Martin, Jennifer C. Goldsack, Thomas Harkins, Noelle M. Cocoros, Nancy D. Lin, Hana Lipowicz, Debbe McCall, Vinit Nair, Lauren Parlett, Cheryl N. McMahill-Walraven, Richard Platt, Christopher B. Granger
07/24/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator: Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Update on Methods
Presentation
Presentation 07/15/2020
Practical Challenges in the Conduct of Pragmatic Trials Embedded in Health Plans: Lessons of IMPACT-AFib, an FDA-Catalyst Trial
Publication
Publication
Crystal J. Garcia, Kevin Haynes, Sean D. Pokorney, Nancy D. Lin, Cheryl McMahill-Walraven, Vinit Nair, Lauren Parlett, David Martin, Hussein R. Al-Khalidi, Debbe McCall, Christopher B. Granger, Richard Platt, Noelle M. Cocoros
06/26/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator: Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Potential Aims/​Methods
Presentation
Presentation 06/24/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator: Coagulopathy Assessment in Patients with COVID-19: A TriNetX Analysis
Presentation
Presentation 06/24/2020
Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer
Presentation
Presentation 06/11/2020
Concomitant Filled Prescriptions of Oxymorphone or Oxycodone with CYP3A Inhibitors and Inducers
Publication
Publication
D. Tyler Coyle, Tiffany S. Woodworth, David Moeny, Judy Staffa, Tamra Meyer, Corinne Woods, Emily C. Welch, Kevin Haynes, Sengwee Toh, Judith C. Maro
05/26/2020
Conducting Prospective Sequential Surveillance in Real‐World Dynamic Distributed Databases
Publication
Publication
Judith C. Maro, Efe Eworuke, Laura Hou, Emily C. Welch, Margie R. Goulding, Rima Izem, Joo‐Yeon Lee, Sengwee Toh, Bruce Fireman, Michael D. Nguyen
05/25/2020
Reagan-Udall Foundation COVID-19 Evidence Accelerator Presentation: Assessing Natural History, Drug Use and Treatment Impact for COVID-19 in the Sentinel System
Presentation
Presentation
Robert Ball, Jennifer Stacey, Jeffrey S. Brown
05/14/2020
Using and Improving Distributed Data Networks to Generate Actionable Evidence: the Case of Real-World Outcomes in the Food and Drug Administration’s Sentinel System
Publication
Publication
Jeffrey S. Brown, Judith C. Maro, Michael Nguyen, Robert Ball
04/11/2020
Distributed Regression Analysis Application in Large Distributed Data Networks: Analysis of Precision and Operational Performance
Publication
Publication
Qoua Her, Jessica Malenfant, Zilu Zhang, Yury Vilk, Jessica Young, David Tabano, Jack Hamilton, Ron Johnson, Marsha Raebel, Denise Boudreau, Sengwee Toh
04/06/2020
Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer
Presentation
Presentation 03/05/2020
Canadian Mother-Child Cohort (CAMCCO) Active Surveillance 1st Team and Stakeholders Symposium: Sentinel Mother-Infant Linkage and Pregnancy Analyses
Presentation
Presentation
Elizabeth Suarez
02/20/2020
Translating Claims‐Based CHA2DS2‐VaSc and HAS‐BLED to ICD‐10‐CM: Impacts of Mapping Strategies
Publication
Publication
Michael Webster‐Clark, Ting‐Ying Huang, Laura Hou, Sengwee Toh
02/17/2020
The Risk of Febrile Seizures following Influenza and 13-Valent Pneumococcal Conjugate Vaccines
Publication
Publication
Meghan A. Baker, Christopher Jankosky, Katherine Yih, Susan Gruber, Lingling Li, Noelle M. Cocoros, Hana Lipowicz, Claudia Coronel-Moreno, Sandra DeLuccia, Nancy D. Lin, Cheryl N. McMahill-Walraven, David Menschik, Mano S. Selvan, Nandini Selvam, Rong Chen Tilney, Lauren Zichittella, Grace M. Lee, Alison Tse Kawai
01/31/2020
Understanding Utilization Patterns of Biologics and Biosimilars in the United States to Support Postmarketing Studies of Safety and Effectiveness
Publication
Publication
Sarah K. Dutcher, Elnara Fazio‐Eynullayeva, Efe Eworuke, Amanda Carruth, Elizabeth C. Dee, Michael D. Blum, Michael D. Nguyen, Sengwee Toh, Catherine A. Panozzo, Jennifer G. Lyons
12/11/2019
Medical Product Safety Surveillance: Data Quality in the Sentinel Initiative
Presentation
Presentation
Judith C. Maro
12/02/2019
Use of Antidiabetic Drugs During Pregnancy among U.S. Women with Livebirth Deliveries in the Mini-Sentinel System
Publication
Publication
Katrina Mott, Marsha E. Reichman, Sengwee Toh, Caren Kieswetter, Katherine Haffenreffer, Susan E. Andrade
11/27/2019
Redesigning PopMedNet for Distributed Regression Analysis with Vertically Partitioned Data
Presentation
Presentation 11/19/2019
Quantifying How Small Variations in Design Elements Affect Risk in an Incident Cohort Study in Claims
Publication
Publication
Rima Izem, Ting-Ying Huang, Laura Hou, Ella Pestine, Michael D. Nguyen, Judith C. Maro
11/17/2019
2019 AHA Scientific Sessions Poster: Myopathy and Rhabdomyolysis with Concomitant Use of Ticagrelor and High-Intensity Statins in the Elderly
Presentation
Presentation
Mohamed Mohamoud, Daniel Woronow, Nicole Haug, Daniel Bak, Eileen Wu, Corinne Woods, Monica Munoz, Grace Chai, Danijela Stojanovic, Ting-Ying Huang
11/15/2019
Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy
Publication
Publication
Janet Sultana, Francesco Trotta, Antonio Addis, Jeffrey S. Brown, Miguel Gil, Francesca Menniti-Ippolito, Federica Milozzi, Samy Suissa, Gianluca Trifirò
10/22/2019
Reproducing Protocol‐based Studies Using Parameterizable Tools – Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks
Publication
Publication
Ting‐Ying Huang, Emily C. Welch, Mayura U. Shinde, Robert W. Platt, Kristian B. Filion, Laurent Azoulay, Judith C. Maro, Richard Platt, Sengwee Toh
10/19/2019
Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis
Publication
Publication
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
10/10/2019
Use of Time-Dependent Propensity Scores to Adjust Hazard Ratio Estimates in Cohort Studies with Differential Depletion of Susceptibles
Publication
Publication
Richard Wyss, Joshua Gagne, Yueqin Zhao, Esther Zhou, Jacqueline Major, Shirley Wang, Rishi Desai, Jessica Franklin, Sebastian Schneeweiss, Sengwee Toh, Margaret Johnson, Bruce Fireman
09/26/2019
Identification of Potential Drug Name Confusion Errors in the Sentinel System
Publication
Publication
Noelle M. Cocoros, Kevin Haynes, Qoua Her, Austin Cosgrove, Elizabeth Dee, Nancy D. Lin, Chi‐Ming Tu, Yulan Ding, Michael Nguyen, Sengwee Toh
09/04/2019
2019 ICPE Poster: Characteristics and Treatment Status of Those with Influenza-Like Illness: Implications for Effectiveness Studies and Surveillance
Presentation
Presentation
Crystal J. Garcia, Nicole R. Haug, Catherine A. Panozzo, Austin C. Cosgrove, Henry Francis, Alfred F. Sorbello, Orbert P. Orr, Gregory T. Measer, Sarah K. Dutcher, Noelle M. Cocoros
08/28/2019
2019 ICPE Poster: Utilization of Prescription Anti-Obesity Drugs in the U.S. Food and Drug Administration's (FDA) Sentinel System, 2008-2017
Presentation
Presentation
Sara Azimi-Bolourian, Emily C. Welch, Candace C. Fuller, Rajani Rajbhandari, Christian Hampp, Michael D. Nguyen
08/28/2019
2019 ICPE Poster: Identification of Ordinal Endpoints Indicating Influenza Complications: A Feasibility Analysis Relevant to the Study of Medical Countermeasures
Presentation
Presentation
Austin Cosgrove, Nicole Haug, Catherine Panozzo, Gregory Measer, Robert Orr, Alfred Sorbello, Henry Francis, Crystal Garcia, Sarah Dutcher, Noelle Cocoros
08/28/2019
2019 ICPE Poster: Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis
Presentation
Presentation
Mohamed Mohamoud, Casie Horgan, Veronica Sansing-Foster, Elizabeth Dee, Justin Bohn, Oren Shapira, Efe Eworuke, Monica Munoz, Danijela Stojanovic, Lois La Grenade
08/28/2019
2019 ICPE Poster: Biosimilar Use in the United States: A Sentinel Analysis of Filgrastim and Infliximab
Presentation
Presentation
Sarah K. Dutcher, Efe Eworuke, Elnara Fazio-Eynullayeva, Elizabeth Dee, Michael D. Nguyen, Catherine A. Panozzo
08/28/2019
2019 ICPE Poster: Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy
Presentation
Presentation
James Phillip Trinidad, Talia Menzin, Elizabeth Dee, Monique Falconer, Mayura Shinde
08/28/2019
2019 ICPE Poster: Duration of Follow-up of Chronic Condition Cohorts in the Sentinel System
Presentation
Presentation
Emily C. Welch, Ting-Ying Huang, Mayura Shinde, Michael D. Nugyen, Sarah K. Dutcher
08/27/2019
2019 ICPE Presentation: Utility of Prenatal Tests and Fertility Coding to Estimate Pregnancy Start in the Sentinel Distributed Database
Presentation
Presentation
Lockwood G. Taylor, Steven T. Bird, Danijela Stojanovic, Darren Toh, Elnara Fazio-Eynullayeva, Andrew Petrone, Rajani Rajbhandari, Jennifer G. Lyons
08/27/2019
2019 ICPE Presentation: 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Kawasaki Disease
Presentation
Presentation
Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, Katherine Yih
08/27/2019
2019 ICPE Poster: Confounding Variable Capture in Large Healthcare Administrative Claims Database: A Trend Analysis in the Sentinel System
Presentation
Presentation
Wei Liu, Austin Cosgrove, Sarah Dutcher, Justin Bohn
08/27/2019
2019 ICPE Poster: Evidence of Residual Confounding in Healthcare Database Studies of Oseltamivir and Influenza Complications
Presentation
Presentation
Phyo T. Htoo, Gregory Measer, Robert Orr, Justin Bohn, Alfred Sorbello, Henry Francis, Sarah Dutcher, Sengwee Darren Toh, Noelle M. Cocoros
08/26/2019
2019 ICPE Poster: Exposure to N-nitrosodimethylamine (NDMA)/​N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States
Presentation
Presentation
Efe Eworuke, Emily C. Welch, Veronica Sansing-Foster, Marie Bradley, Judith C. Maro
08/26/2019
2019 ICPE Presentation: Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings
Presentation
Presentation 08/26/2019
2019 ICPE Presentation: Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis
Presentation
Presentation
Christian Hampp
08/26/2019
2019 ICPE Symposium: Thinking Globally While Acting Locally: Developing Time-on-Treatment Data In International Settings
Presentation
Presentation
Judith C. Maro, Kristian B. Fillion, Achim Wolf, Kevin Haynes, Michael D. Nguyen
08/26/2019
2019 ICPE Presentation: A General Propensity Score for Signal Detection using Tree-Based Scan Statistics
Presentation
Presentation
Shirley V. Wang, Joshua J. Gagne, Judith C. Maro, Sushama Kattinakere, Danijela Stojanovic, Efe Eworuke, Elande Baro, Rita Ouellet-Hellstrom, Michael Nguyen, Elisabetta Patorno, Sandra DeLuccia, Ella Pestine, Yong Ma, Martin Kulldorff
08/26/2019
2019 ICPE Symposium: Experience from US FDA Sentinel Initiative Studies
Presentation
Presentation 08/26/2019
2019 ICPE Poster: Phosphodiesterase Type 5 (PDE-5) Inhibitor Use Among Pregnant Women and Women of Reproductive Age in the United States
Presentation
Presentation
Wei Liu, Talia Menzin, Corinne M. Woods, Nicole Haug, Jie Li, Justin A. Mathew, Christine P. Nguyen, Grace P. Chai, David Moeny, Mayura Shinde
08/26/2019
2019 ICPE Poster: Epidemiology of Pediatric Respiratory Syncytial Virus-Associated Illnesses in Young Children
Presentation
Presentation
Amol Purandare, Prabha Viswanathan, Nicole Haug, Noelle Cocoros, Rongmei Zhang, Marscha Reichman, Michael Nguyen, Ann McMahon
08/26/2019
2019 ICPE Poster: Characteristics of NOAC Users Aged Less Than 65 Years in the Sentinel System
Presentation
Presentation
Marie C. Bradley, Emily C. Welch, Efe Eworuke, Rongmei Zhang, Elande Baro, David J. Graham, Mayura Shinde
08/26/2019
Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations
Publication
Publication
James E. Sabin, Noelle M. Cocoros, Crystal J. Garcia, Jennifer C. Goldsack, Kevin Haynes, Nancy D. Lin, Debbe McCall, Vinit Nair, Sean D. Pokorney, Cheryl N. McMahill‐Walraven, Christopher B. Granger, Richard Platt
08/20/2019
First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies
Publication
Publication
Steven T. Bird, Kate Gelperin, Leyla Sahin, Karen B. Bleich, Elnara Fazio-Eynullayeva, Corinne Woods, Erica Radden, Patty Greene, Carolyn McCloskey, Tamara Johnson, Mayura Shinde, Ira Krefting
08/20/2019
Development of an Algorithm to Detect Methotrexate Wrong Frequency Error Using Computerized Health Care Data
Publication
Publication
Lisa J. Herrinton, Tiffany S. Woodworth, Efe Eworuke, Laura B. Amsden, Liyan Liu, Jo Wyeth, Andrew Petrone, Talia J. Menzin, James Williams, Robert Goldfien, Michael Nguyen
08/13/2019
Kawasaki Disease and 13-Valent Pneumococcal Conjugate Vaccination Among Young Children: A Self-Controlled Risk Interval and Cohort Study with Null Results
Publication
Publication
Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, W. Katherine Yih
07/02/2019
Signal Identification Methods in the Sentinel System
Presentation
Presentation
Judith C. Maro
06/12/2019
Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program
Publication
Publication
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
Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population
Publication
Publication
Lockwood G. Taylor, Genna Panucci, Andrew D. Mosholder, Sengwee Toh, Ting-Ying Huang
06/04/2019
Medical Product Safety: Ten Years of the U.S. Sentinel System
Presentation
Presentation
Sarah Dutcher, Judith C. Maro, David Martin
05/23/2019
Evaluation of Use of Technologies to Facilitate Medical Chart Review
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Presentation
Presentation 02/20/2019
Cross‐Network Directory Service: Infrastructure to Enable Collaborations Across Distributed Research Networks
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Robert W. Platt, Richard Platt, Jeffrey S. Brown, David A. Henry, Olaf H. Klungel, Samy Suissa
01/15/2019
Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel
Presentation
Presentation
Danijela Stojanovic
11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10
Presentation
Presentation
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
Presentation
Presentation 11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App
Presentation
Presentation 11/29/2018
The FDA Sentinel Initiative — An Evolving National Resource
Publication
Publication
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
Publication
Publication
Sonal Singh, 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
Publication
Publication
Noelle M. Cocoros, 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
Publication
Publication
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
Publication
Publication
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
A Generalizable Smartphone-Based Clinical Research Platform
Presentation
Presentation 11/05/2018
Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance
Presentation
Presentation
Zachary Wyner, Juliane Reynolds, Chayim Herzig-Marx, Shyam Deval, Adam Rauch, Jeffrey Brown, David Martin
11/04/2018
Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System
Publication
Publication
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
Presentation
Presentation
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
Publication
Publication
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
Publication
Publication
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
Presentation
Presentation 09/12/2018
Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System
Publication
Publication
Robert Ball, Sengwee Toh, Jamie Nolan, Kevin Haynes, Richard Forshee, Taxiarchis Botsis
08/28/2018
2018 ICPE Presentation: Validation of Transfusion Administrations Among Potential Transfusion-Related Acute Lung Injury (TRALI) Patients Included in the Sentinel Distributed Database
Presentation
Presentation
Mayura U. Shinde, Meghan A. Baker, Caren Spencer‐Smith, Lesley H. Curtis, Steven A. Anderson, Austin Cosgrove, Richard Forshee, Jason Hickok, Adee Kennedy, David J. Mohlman, Mikhail Menis, Karla M. Miller, Manette Niu, Joyce Obidi, Wendy Paul, Russell Poland, Robert Rosofsky, Kimberly Smith, Salim Surani, Vinod Easwaran Nambudiri, Craig Zinderman, Azadeh Shoaibi, Candace C. Fuller
08/26/2018
2018 ICPE Poster: Assessment of Transfusion-Related Acute Lung Injury (TRALI) after Blood Transfusion
Presentation
Presentation
Candace C. Fuller, Craig Zinderman, Caren Spencer-Smith, Kimberly Smith, Steven A. Anderson, Lesley H. Curtis, Richard Forshee, Jason Hickok, Stacey Honda, Richard Max Kaufman, Adee Kennedy, Mikhail Menis, Karla M. Miller, Manette Niu, Joyce Obidi, Wendy Paul, Russell Poland, Robert Rosofsky, Robert Jin, Rong Tilney, Mayura U. Shinde, Azadeh Shoaibi, Fang Zhang, Lauren Zichittella, Meghan A. Baker
08/25/2018
2018 ICPE Poster: Misclassification of Time-at-Risk Due to Free Drug Sample Use: A Simulation Study
Presentation
Presentation
Zilu Zhang, Efe Eworuke, Margie R. Goulding, Michael D. Nguyen, Bruce Fireman, Judith C. Maro
08/23/2018
2018 ICPE Presentation: Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic
Presentation
Presentation
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
08/23/2018
2018 ICPE Poster: First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies
Presentation
Presentation
Steven Bird, Kate Gelperin, Leyla Sahin, Karen B. Bleich, Elnara Fazio-Eynullayeva, Corinne Woods, Erica Radden, Tamara Johnson, Mayura Shinde, Ira Krefting
08/23/2018
2018 ICPE Presentation: Using Time-Dependent Propensity Scores to Correct for Differential Depletion of Susceptibles when Estimating Hazard Ratios in Time-to-Event Data
Presentation
Presentation 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
Presentation
Presentation
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
08/22/2018
2018 ICPE Presentation: Early Lessons on ICD-10-CM/​PCS Transition in Claims-Based Drug Safety Assessments
Presentation
Presentation
Ting‐Ying Huang, Emily C. Welch, Margie Goulding, David J. Graham, Rongmei Zhang, Marie Bradley
08/22/2018
2018 ICPE Presentation: Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs
Presentation
Presentation
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
08/22/2018
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
Presentation
Presentation
Mohamed Mohamoud, Yanmin Zhu, Steven Bird, Rima Izem, Nicole R. Haug, Anita Wagner, Judith C. Maro, Efe Eworuke
08/22/2018
2018 ICPE Presentation: Minor Differences, Major Consequences? Lessons Learned from Replication of a Claims-Based Drug Safety Assessment
Presentation
Presentation
Ting-Ying Jane Huang, Laura Hou, Laura Shockro, Ella Pestine, Michael Nguyen, Judith C. Maro, Rima Izem
08/22/2018
2018 ICPE Presentation: Use of Multiple Sclerosis Drugs Among Live Birth Pregnancies in the United States
Presentation
Presentation
Danijela Stojanovic, Mayura Shinde, Nicole Haug, Mohamed Mohamoud, Leyla Sahin, Genna Panucci, Rajani Rajbhandari, Lockwood Taylor
08/22/2018
2018 ICPE Presentation: Signal Detection using TreeScan with Drug Classes: Pilot Projects in Sentinel
Presentation
Presentation
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
08/22/2018
2018 ICPE Poster: A New Analytic Tool Developed in the Sentinel System to Assess Adherence To FDA’s Safe Use Recommendations
Presentation
Presentation
Noelle Cocoros, Anita Wagner, Andrew Petrone, Elnara Fazio-Eynullayeva, Yulan Ding, Rima Izem, Joo-Yeon Lee, Jacqueline Major, Michael Nguyen, Jing Ju
08/21/2018
2018 ICPE Presentation: Data-Mining for Adverse Events Using the Self-Controlled Tree-Temporal Scan Statistic
Presentation
Presentation 08/21/2018
2018 ICPE Presentation: Estimating “Optimal” Durations for Initial Opioid Analgesic Prescription Following Common Surgical Procedures
Presentation
Presentation
Mallika L. Mundkur, Tamra Meyer, Talia Menzin, Judy Staffa, Corinne Woods, Judith C. Maro, Justin Bohn
08/21/2018
2018 ICPE Presentation: Validation of the Combined Comorbidity Score in the ICD-10 Era: Application to High-Risk Populations
Presentation
Presentation
Justin Bohn, Emily C. Welch, Jenny W. Sun, Joshua J. Gagne, Sengwee Darren Toh
08/21/2018
2018 ICPE Presentation: Performance of a Distributed Regression Analysis Software and Workflow
Presentation
Presentation
Qoua L. Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Darren Toh
08/21/2018
2018 ICPE Workshop: Sequential and SequentialDesign: Tools For Prospective Sequential Medical Product Safety Surveillance
Presentation
Presentation
Judith C. Maro, Efe Eworuke, Andreia Leite, Martin Kulldorff
08/21/2018
2018 ICPE Symposium: Long Live the "Medical Data Janitors": International Data Quality Assurance Practices in Distributed Data Network
Presentation
Presentation
Judith C. Maro, Christian G. Reich, Keith Marsolo, Yoshiaki Uyama, Kristian B. Filion, Miriam C.J.M. Sturkenboom
08/21/2018
2018 ICPE Presentation: Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes Of Interest – An Empirical Evaluation
Presentation
Presentation
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
08/21/2018
2018 ICPE Symposium: Advances in the Study of Medication Errors in Computerized Healthcare Databases and Spontaneous Reporting Systems in Europe and North America
Presentation
Presentation
Michael D. Nguyen, Jo Wyeth, Kevin Haynes, Lisa Herrinton, Rodrigo Postigo, Adrian Levy, Chi-Ming (Alice) Tu
08/21/2018
2018 ICPE Poster: Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA's Sentinel System
Presentation
Presentation
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
08/21/2018
2018 ICPE Poster: Developing the Infrastructure to Assess Pregnancy Outcomes Following Vaccination: Influenza Vaccines and Spontaneous Abortion as a Use Case
Presentation
Presentation
Alison Tse Kawai, Megan Reidy, Lauren Zichittella, Colleen Stockdale, Erin Longley, Cheryl Walraven, Chunfu Liu, Azadeh Shoaibi, Sandra Feibelmann, Grace Lee
08/21/2018
2018 ICPE Poster: Computational Algorithms for Distributed Regression Analysis Based on SAS Software
Presentation
Presentation
Qoua Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Sengwee Toh
08/21/2018
2018 ICPE Poster: Diagnostic Algorithms for Identification of Cardiovascular Death in Administrative Claims Databases: A Systematic Review
Presentation
Presentation
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
08/21/2018
Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Richard Platt and Tracy Lieu
08/06/2018
Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
A Query Workflow Design to Perform Automatable Distributed Regression Analysis in Large Distributed Data Networks
Publication
Publication
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
Presentation
Presentation
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System
Publication
Publication
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
02/23/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Venous Thromboembolism among Intravenous Immune Globulin Users in the Sentinel Distributed Database
Publication
Publication
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
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
Publication
Publication
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
Butterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal Inference
Presentation
Presentation 01/12/2018
Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Publication
Publication
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
Presentation
Presentation
Vojtech Huser, Michael Kahn, and Jeffrey Brown
01/03/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database
Publication
Publication
Eric M. Ammann MS; Enrique C. Leira MD, MS; Scott K. Winiecki MD; Nandakumar Nagaraja MD, MS; Sudeepta Dandapat MD; Ryan M. Carnahan PharmD, MS, BCPP; Marin L. Schweizer PhD; James C. Torner PhD; Candace C. Fuller PhD; Charles E. Leonard PharmD, MSCE; Crystal Garcia MPH; Madelyn Pimentel; Elizabeth A. Chrischilles PhD, MS
12/01/2017
Opioid Tolerance and Urine Drug Testing among Initiates of Extended-Release or Long-Acting Opioids in Food and Drug Administration's Sentinel System
Publication
Publication
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
11/20/2017
Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study
Publication
Publication
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
11/14/2017
Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System
Publication
Publication
Joshua J. Gagne PharmD, ScD; Monika Houstoun PharmD; Marsha E. Reichman PhD; Christian Hampp PhD; James H. Marshall MPH; Sengwee Toh ScD
11/06/2017
Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study
Publication
Publication
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
11/01/2017
Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network
Publication
Publication
John G. Connolly SM; Shirley V. Wang PhD, ScM; Candace C. Fuller PhD; Sengwee Toh ScD; Catherine A. Panozzo PhD; Noelle Cocoros DSc; Meijia Zhou MHS; Joshua J. Gagne PharmD, ScD; Judith C. Maro PhD, MS
10/06/2017
A Review of the Performance of Different Methods for Propensity Score Matched Subgroup Analyses and a Summary of their Application in Peer-Reviewed Research Studies
Publication
Publication
Shirley V. Wang PhD, ScM; Mengdong He MS; Yinzhu Jin MS, MPH; Richard Wyss PhD; HoJin Shin MS; Yong Ma PhD, MS; Stephine Keeton PhD; Bruce Fireman MA; Sara Karami PhD, MPH; Jacqueline M. Major PhD; Sebastian Schneeweiss MD, ScD; Joshua Gagne PharmD, ScD
10/06/2017
Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia (Video Abstract)
Presentation
Presentation
Meijia Zhou, Sean Hennessy
10/06/2017
The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011
Publication
Publication
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
09/14/2017
Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies
Publication
Publication
Steven T. Bird PharmD, PhD, MS; Kate Gelperin MD; Lockwood Taylor PhD, MPH; Leyla Sahin MD; Hoda Hammad MS, MPH; Susan E. Andrade ScD; Mohamed A. Mohamoud PharmD, MPH; Sengwee Toh, ScD; Christian Hampp PhD
08/29/2017
2017 ICPE Presentation: Promises and Challenges of Screening for Adverse Events in Sentinel
Presentation
Presentation
Michael Nguyen
08/28/2017
2017 ICPE Presentation: Impact of ICD-10-CM Transition on Selected Cardiovascular-Related Events in the Sentinel System
Presentation
Presentation
Tiffany Siu Woodworth
08/26/2017
2017 ICPE Workshop: TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance
Presentation
Presentation
Judith Maro, Rima Izem, Martin Kulldorff, Azadeh Shoaibi
08/26/2017
2017 ICPE Poster: A Review of Methods for Propensity Score Matched Subgroup Analysis and Their Application in Peer Reviewed Research Studies
Presentation
Presentation
Shirley Wang, PhD, ScM, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
08/26/2017
2017 ICPE Presentation: Identification of Name Confusion Medication Errors in the US FDA's Sentinel System
Presentation
Presentation
Noelle Cocoros
08/26/2017
2017 ICPE Poster: Early Post-Approval Surveillance of New Molecular Entity Uptake in the Sentinel Distributed Database
Presentation
Presentation
Nicole R. Haug, MPH, Dept. of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, MA
08/26/2017
2017 ICPE Presentation: Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database
Presentation
Presentation
Richard Scott Swain
08/26/2017
2017 ICPE Poster: Evaluation of Test Data in Distributed Research Networks: A Sentinel System Example
Presentation
Presentation
Emily C. Welch
08/26/2017
2017 ICPE Presentation: Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System
Presentation
Presentation
Noelle Cocoros
08/26/2017
2017 ICPE Poster: Dispensings of Influenza Antiviral Medications in the Sentinel System as a Source of Data for Influenza Surveillance
Presentation
Presentation
Noelle Cocoros
08/26/2017
2017 ICPE Presentation: Curating Inpatient Medication Use Data from a Hospital Network Electronic Medication Administration Record (eMAR) System: Lessons from the Sentinel System About Expanding Drug Safety Surveillance Potential
Presentation
Presentation
Jennifer R. Popovic
08/26/2017
2017 ICPE Poster: Distributed Regression Analysis in a Distributed Health Data Network
Presentation
Presentation
Jessica M. Malenfant, MPH, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA
08/26/2017
2017 ICPE Symposium: Listening to Patient Voices in Pharmacoepidemiological Research - Opportunities for Innovation and Inclusion
Presentation
Presentation
Wendy Camello Castillo
08/26/2017
2017 ICPE Presentation: Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Presentation
Presentation
Elizabeth Chrischilles
08/26/2017
2017 ICPE Presentation: Developing a Mother-Infant Cohort in Sentinel's PRISM Program as a Resource to Monitor the Safety of Vaccine Use During Pregnancy
Presentation
Presentation 08/26/2017
2017 ICPE Presentation: Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database
Presentation
Presentation
Crystal Garcia
08/26/2017
2017 ICPE Presentation: Protocol-Based Assessment of Thromboembolic Events (TEEs) after Intravenous Immune Globulin (IVIg) in the Sentinel Distributed Database (2006-2012)
Presentation
Presentation
Eric Ammann PhD, University of Iowa, College of Public Health, Iowa City, IA
08/26/2017
2017 ICPE Poster: Opportunities for Rapid Monitoring of New Cancer Treatments: Tyrosine Kinase Inhibitors in the Sentinel Distributed Database
Presentation
Presentation
Anita K. Wagner, PharmD, MPH, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA
08/26/2017
2017 ICPE Poster: Evaluation of Case-Finding Algorithm for Venous Thromboembolism Outcome
Presentation
Presentation
Megan Reidy, Jill L.O. de Jong, Lauren Zichittella, W. Katherine Yih
08/26/2017
2017 ICPE Pre-Conference Course: Using the Self-Controlled Risk Interval (SCRI) Method to Study Vaccine Safety
Presentation
Presentation 08/26/2017
2017 ICPE Presentation: Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth
Presentation
Presentation 08/26/2017
2017 ICPE Poster: Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System
Presentation
Presentation 08/26/2017
2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year
Presentation
Presentation
Michael D. Nguyen, Judith C. Maro, Lockwood G. Taylor, David Moeny, Efe Eworuke, Steven Bird
08/25/2017
2017 ICPE Presentation: Expansion of the US FDA's Sentinel System to Inpatient Blood Transfusion Data from Hospital Corporation of America: New Surveillance Options
Presentation
Presentation
Candace Fuller
08/25/2017
2017 ICPE Poster: Assessment of Transfusion-Related Acute Lung Injury After Red Blood Cell, Plasma and Platelet Administration: Initial Results in the Sentinel System
Presentation
Presentation
Candace C. Fuller
08/25/2017
2017 ICPE Presentation: Developing a Mobile App for Studies of Medication Safety
Presentation
Presentation 08/25/2017
2017 ICPE Plenary: Medical Product and Performance Evaluation Programs Using Distributed Data Sources
Presentation
Presentation
Richard Platt MD, Robert Ball
08/25/2017
2017 ICPE Presentation: Randomized Clinical Trial Using FDA's Sentinel Infrastructure: An Analysis Assessing Feasibility
Presentation
Presentation
Noelle Cocoros on behalf of Crystal Garcia
08/24/2017
2017 ICPE Poster: Type 1 and Type 2 Diabetes Mellitus Identification Using ICD-9-CM Codes Within a Cohort of New Users of Drugs Labeled for Type 2 Diabetes Mellitus
Presentation
Presentation 08/24/2017
Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners
Publication
Publication
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
Publication
Publication
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, Sean Hennessy PharmD, PhD
07/04/2017
Statistical Power for Postlicensure Medical Product Safety Data-Mining
Publication
Publication
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
Publication
Publication
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
Publication
Publication
James H. Flory MD, MS; Jason Roy PhD; Joshua Gagne PharmD, ScD; Kevin Haynes PharmD, ScD; Lisa Herrinton PhD; Christine Lu PhD, MSc; Elisabetta Patorno MD, DrPH; Azadeh Shoaibi PhD, MHS; Marsha Raebel PharmD
01/06/2017
Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Presentation
Presentation
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
08/25/2016
2016 ICPE Presentation: Monitoring All Drugs for a Specific Outcome in the Sentinel System
Presentation
Presentation
Judith C. Maro, Gerald Dal Pan, Jeffrey S. Brown, Inna Dashevsky, Martin Kulldorff
08/24/2016
2016 ICPE Presentation: Assessing Quadrivalent HPV Vaccine Safety using the Self-Controlled Tree-Temporal Scan Statistic
Presentation
Presentation
Martin Kulldorff, Katherine Yih
08/24/2016
2016 ICPE Poster: A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems
Presentation
Presentation
Steven T. Bird, Kate Gelperin, Lockwood Taylor, Leyla Sahin, Mohamed Mohamoud, Christian Hampp
08/24/2016
2016 ICPE Poster: Utilization of Laboratory Results Data to Enhance Pregnancy Cohort Identification in a Distributed Data Network
Presentation
Presentation
Kevin Haynes, Andrew Sterrett, Susan M. Shetterly, Mano S. Selvan, Joshua J. Gagne, Christine Y. Lu, Azadeh Shoaibi, Marsha A. Raebel
08/24/2016
2016 ICPE Poster: Do Hemoglobin Lab Test Results Increase Detection of Upper Gastrointestinal Bleeding (UGIB)?
Presentation
Presentation
Elisabetta Patorno, Joshua J. Gagne, Christine Y. Lu, Kevin Haynes, Andrew T. Sterrett, Jason Roy, Xingmei Wang, Marsha A. Raebel
08/24/2016
2016 ICPE Poster: Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA's Sentinel Program
Presentation
Presentation
John G. Connolly, Joshua J. Gagne
08/24/2016
2016 ICPE Poster: A Framework for Rapid Medical Product Safety Assessment: FDA's Sentinel Toolkit
Presentation
Presentation
Elizabeth Cavagnaro, Hannah Katcoff, Candace Fuller, Jennifer R. Popovic, Tiffany S. Woodworth, Nicolas Beaulieu, April Duddy, Eric Gravel, Erick Moyneur, Sengwee Toh, Jeffrey Brown
08/24/2016
2016 ICPE Symposium: ICD-10-CM: Is Sentinel Ready?
Presentation
Presentation 08/24/2016
2016 ICPE Presentation: Assessment of the US Food and Drug Administration’s Sentinel Analysis Tools: Angiotensin-Converting Enzyme Inhibitors and Angioedema
Presentation
Presentation 08/24/2016
2016 ICPE Presentation: Ondasetron Use Among Pregnancies Identified in the Sentinel Distributed Database
Presentation
Presentation
Lockwood G. Taylor
08/24/2016
2016 ICPE Presentation: Utilization Patterns for Products with Pregnancy Exposure Registries in Pregnant Versus Non-Pregnant Women in the Sentinel Database
Presentation
Presentation
Steven T. Bird, Lockwood Taylor, Christian Hampp, Kate Gelperin, Darren Toh, Susan Andrade, Katie Haffenreffer, Marsha Reichman, Leyla Sahin
08/24/2016
2016 ICPE Presentation: Diagnosis-Based Cohort Augmentation Using Laboratory (Lab) Data in the FDA Sentinel Initiative: The Case of Chronic Kidney Disease (CKD)
Presentation
Presentation
David H. Smith
08/24/2016
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association
Publication
Publication
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
Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
04/30/2016
Intravenous Immune Globulin and Thromboembolic Adverse Events: A Systematic Review and Meta-Analysis of RCTs
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Allison L. Naleway PhD; Brad Crane; 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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Ivair R. Silva PhD; Martin Kulldorff PhD
05/22/2015
A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Lesley H. Curtis PhD; Jeffrey S. Brown PhD; Richard Platt MD, MSc
07/01/2014
Electronic Clinical Laboratory Test Results Data Tables: Lessons from Mini-Sentinel
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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 for Identifying Systemic Lupus Erythematosus (SLE) using Administrative or Claims Data
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Candice L. Williams MD, MPH; Nila A. Sathe MA, MLIS; Shanthi Krishnaswami MMS; Melissa McPheeters PhD, MPH
12/30/2013
A Systematic Review of Validated Methods to Capture Myopericarditis using Administrative or Claims Data
Publication
Publication
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
Publication
Publication
Cecilia P. Chung MD, MPH; Patricia Rohan MD; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH
12/30/2013
Validation of Anaphylaxis in the Food and Drug Administration's Mini-Sentinel
Publication
Publication
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
Presentation
Presentation
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Becky A. Briesacher PhD; Stephen B. Soumerai ScD; Fang Zhang PhD; Sengwee Toh ScD; Susan Andrade ScD; Joann L. Wagner MSW; Azadeh Shaoibi PhD, MS, MHS; Jerry H. Gurwitz MD
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Bruce M. Psaty MD, PhD; Eric B. Larson MD, MPH
05/08/2013
Is Size the Next Big Thing in Epidemiology?
Publication
Publication
Sengwee Toh ScD; Richard Platt MD, MSc
05/01/2013
Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding
Publication
Publication
Mary Ross Southworth PharmD; Marsha E. Reichman PhD; Ellis F. Unger MD
04/04/2013
Comparative Risk for Angioedema Associated with the Use of Drugs that Target the Renin-Angiotensin-Aldosterone System
Publication
Publication
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
Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance
Publication
Publication
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
Validation of Acute Myocardial Infarction in the Food and Drug Administration's Mini-Sentinel Program
Publication
Publication
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
Health Outcomes of Interest for Evaluation in the Postlicensure Rapid Immunization Safety Monitoring Program
Publication
Publication
Tracy A. Lieu MD, MPH; Michael D. Nguyen MD; Robert Ball MD, MPH, ScM; David B. Martin MD, MPH
04/16/2012
Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative Data: Summary of Findings and Suggestions for Future Research
Publication
Publication
Ryan M. Carnahan PharmD, MS, BCPP
02/05/2012
PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program
Publication
Publication
Richard Platt MD, MSc; Ryan M. Carnahan PharmD, MS, BCPP
01/31/2012
Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data
Publication
Publication
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
01/19/2012
A Systematic Review of Validated Methods for Identifying Transfusion-Related ABO Incompatibility Reactions using Administrative and Claims Data
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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 and Claims Data: Methods and Lessons Learned
Publication
Publication
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
Publication
Publication
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
A Systematic Review of Validated Methods for Identifying Hypersensitivity Reactions other than Anaphylaxis (Fever, Rash, and Lymphadenopathy), using Administrative and Claims Data
Publication
Publication
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 Cerebrovascular Accident or Transient Ischemic Attack using Administrative Data
Publication
Publication
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
01/19/2012
A Systematic Review of Validated Methods for Identifying Pulmonary Fibrosis and Interstitial Lung Disease using Administrative and Claims Data
Publication
Publication
Natalie Jones BS; Gary Schneider ScD, MSPH; Sumesh Kachroo PhD; 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
Publication
Publication
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
Publication
Publication
Natalie Jones BS; Gary Schneider ScD, MSPH; 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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Leo Tamariz MD, MPH; Thomas Harkins MA, MPH; Vinit Nair BPharm, MS, RPh
01/19/2012
A Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical Agent
Publication
Publication
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
01/19/2012
The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product Safety
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
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
Publication
Publication
Deven McGraw JD, LLM; Kristen B. Rosati JD; Barbara Evans PhD, JD
01/19/2012
A Systematic Review of Validated Methods for Identifying Seizures, Convulsions, or Epilepsy using Administrative and Claims Data
Publication
Publication
Vicki Kee PharmD; Bradley Gilchrist BS; Mark A. Granner MD; Nicola R. Sarrazin PharmD; Ryan M. Carnahan PharmD, MS
01/19/2012
Design Considerations, Architecture, and Use of the Mini-Sentinel Distributed Data System
Publication
Publication
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; Jeffrey S. Brown PhD
01/19/2012
A Systematic Review of Validated Methods for Identifying Pancreatitis using Administrative Data
Publication
Publication
Kevin Moores PharmD; Bradley Gilchrist BS; Ryan Carnahan PharmD, MS; Thad Abrams MD, MSc
01/19/2012
Design Considerations in an Active Medical Product Safety Monitoring System
Publication
Publication
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
A Systematic Review of Validated Methods for Identifying Lymphoma using Administrative Data
Publication
Publication
Ronald Herman PhD; Bradley Gilchrist BS; Brian Link MD; Ryan Carnahan PharmD, MS
01/19/2012
Using High-Dimensional Propensity Scores to Automate Confounding Control in a Distributed Medical Product Safety Surveillance System
Publication
Publication
Jeremy A. Rassen ScD; Sebastian Schneeweiss MD, ScD
01/19/2012
A Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims Data
Publication
Publication
Ryan Carnahan, PharmD, MS, BCPP, Ronald Herman, PhD, Kevin G. Moores, PharmD
01/19/2012
When Should Case-Only Designs be used for Safety Monitoring of Medical Products?
Publication
Publication
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 Infection Related to Blood Products, Tissue Grafts, or Organ Transplants using Administrative Data
Publication
Publication
Ryan Carnahan PharmD, MS, BCPP; Kevin Moores PharmD; Eli Perencevich MD, MS; The University of Iowa, Iowa City, IA
01/19/2012
Effects of Adjusting for Instrumental Variables on Bias and Precision of Effect Estimates
Publication
Publication
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
Developing the Sentinel System — A National Resource for Evidence Development
Publication
Publication
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
RSS Feed Scroll to Top