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
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Title | Author(s) | Date Posted | ||
---|---|---|---|---|
Use of Real-World Data for Surveillance of Medications in Pregnancy Presentation |
Presentation |
Danijela Stojanovic
|
05/09/2022 | |
Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021 Publication |
Publication |
Marie C. Bradley, Silvia Perez-Vilar, Yoganand Chillarige, Diane Dong, Ashley I. Martinez, Andrew R. Weckstein, Gerald J. Dal Pan
|
04/08/2022 | |
A Landscape Analysis of Valganciclovir Treatment for Congenital Cytomegalovirus Infection in the United States (US), 2008-2021 Presentation |
Presentation |
Prabha Viswanathan, Ashish Rai, Emmanuel Ojo, Takashi E. Komatsu, Mayura Shinde, Danijela Stojanovic, Adebola Ajao, Hengrui Sun, Amy Bishara, Joy Kolonoski, Ann McMahon
|
03/28/2022 | |
CNODES Webinar: Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics Presentation |
Presentation |
Judy Maro
|
03/09/2022 | |
Utility of Fertility Procedures and Prenatal Tests to Estimate Gestational Age for Live-births and Stillbirths in Electronic Health Plan Databases Publication |
Publication |
Lockwood Taylor, Steven T. Bird, Danijela Stojanovic, Sengwee Toh, Judith C. Maro, Elnara Fazio-Eynullayeva, Andrew B. Petrone, Rajani Rajbhandari, Susan E. Andrade, Kevin Haynes, Cheryl N. McMahill-Walraven, Connie M. Trinacty, Mayura Shinde, Jennifer G. Lyons
|
02/05/2022 | |
Evaluating Confounding Control in Estimations of Influenza Antiviral Effectiveness in Electronic Health Plan Data Publication |
Publication |
Phyo T. Htoo, Gregory Measer, Robert Orr, Justin Bohn, Alfred Sorbello, Henry Francis, Sarah K. Dutcher, Austin Cosgrove, Amanda Carruth, Sengwee Toh, Noelle M. Cocoros
|
02/02/2022 | |
Real-World Data: Data Networks, Standardization, and Federated Analysis Presentation |
Presentation |
Darren Toh
|
01/18/2022 | |
Broadening the Reach of the FDA Sentinel System: A Roadmap for Integrating Electronic Health Record Data in a Causal Analysis Framework Publication |
Publication |
Rishi J. Desai, Michael E. Matheny, Kevin Johnson, Keith Marsolo, Lesley H. Curtis, Jennifer C. Nelson, Patrick J. Heagerty, Judith Maro, Jeffrey Brown, Sengwee Toh, Michael Nguyen, Robert Ball, Gerald Dal Pan, Shirley V. Wang, Joshua J. Gagne, Sebastian Schneeweiss
|
12/20/2021 | |
Validation of Diagnosis Codes to Identify Hospitalized COVID-19 Patients in Health Care Claims Data Publication |
Publication |
Sheryl A. Kluberg, Laura Hou, Sarah K. Dutcher, Monisha Billings, Brian Kit, Sengwee Toh, Sascha Dublin, Kevin Haynes, Anne Marie Kline, Mahesh Maiyani, Pamala A. Pawloski, Eric S. Watson, Noelle M. Cocoros
|
12/16/2021 | |
Self‑Controlled Assessment of Thromboembolic Event (TEE) Risk Following Intravenous Immune Globulin (IGIV) in the U.S. (2006–2012) Publication |
Publication |
Eric M Ammann, Elizabeth A Chrischilles, Ryan M Carnahan, Bruce Fireman, Candace C Fuller, Marin L Schweizer, Crystal Garcia, Madelyn Pimentel, Charles E Leonard, Meghan A Baker, Adam Cuker, Enrique C Leira, Jennifer G Robinson, Scott K Winiecki
|
11/24/2021 | |
Emerging Technologies and Their Impact on Regulatory Science Publication |
Publication |
Elke Anklam, Martin Iain Bahl, Robert Ball, Richard D. Beger, Jonathan Cohen, Suzanne Fitzpatrick, Philippe Girard, Blanka Halamoda-Kenzaoui, Denise Hinton, Akihiko Hirose, Arnd Hoeveler, Masamitsu Honma, Marta Hugas, Seichi Ishida, George E.N. Kass, Hajime Kojima, Ira Krefting, Serguei Liachenko, Yan Liu, Shane Masters, Uwe Marx, Timothy McCarthy, Tim Mercer, Anil Patri, Carmen Pelaez, Munir Pirmohamed, Stefan Platz, Alexandre J.S. Ribeiro, Joseph V. Rodricks, Ivan Rusyn, Reza M. Salek, Reinhilde Schoonjans, Primal Silva, Clive N. Svendsen, Susan Sumner, Kyung Sung, Danilo Tagle, Li Tong, Weida Tong, Janny van den Eijnden-van-Raaij, Neil Vary, Tao Wang, John Waterton, May Wang, Hairuo Wen, David Wishart, Yinyin Yuan, William Slikker Jr.
|
11/16/2021 | |
Using Inpatient Electronic Medical Records to Study Influenza for Pandemic Preparedness Publication |
Publication |
Candace C. Fuller, Austin Cosgrove, Kenneth Sands, Karla M. Miller, Russell E. Poland, Edward Rosen, Alfred Sorbello, Henry Francis, Robert Orr, Sarah K. Dutcher, Gregory T. Measer, Noelle M. Cocoros
|
10/25/2021 | |
Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network Publication |
Publication |
Elizabeth A. Suarez, Nicole Haug, Aaron Hansbury, Danijela Stojanovic, Catherine Corey
|
10/14/2021 | |
Risk of Hospitalized Depression and Intentional Self-Harm with Brand and Authorized Generic Sertraline Publication |
Publication |
Dinci D. Pennap, Richard S. Swain, Emily C. Welch, Justin Bohn, Jennifer G. Lyons, Sarah Dutcher, Andrew D. Mosholder
|
10/05/2021 | |
Monitoring Medication Use During the COVID-19 Pandemic in the Sentinel System: The Case of Anticoagulation for Thrombosis Presentation |
Presentation |
Ashley I. Martinez
|
09/15/2021 | |
Incidence of Severe Uterine Bleeding Outcomes among Oral Anticoagulant Users and Nonusers Publication |
Publication |
Ting-Ying Huang, Laura Hou, Abby Andersen, Audrey Gassman, David Moeny, Efe Eworuke
|
09/01/2021 | |
Characteristics and Outcomes of Pregnancies in Women with Heart Failure: A Retrospective Cohort Study in the Sentinel Distributed Database Presentation |
Presentation |
Yan Li, Austin Cosgrove, Efe Eworuke, Catherine Corey, Joy Kolonoski, Mayura Shinde
|
08/25/2021 | |
Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning Presentation |
Presentation |
David Carrell
|
08/25/2021 | |
Strategies for the Use of Real-World Data to Conduct COVID-19-Related Pharmacoepidemiology Presentation |
Presentation |
Noelle M. Cocoros
|
08/25/2021 | |
A New Analytic Tool for Interrupted Times Series Analysis to Assess the Impact of FDA Regulatory Actions Presentation |
Presentation |
Christine Y. Lu, Laura Hou, Joy Kolonoski, Andrew Petrone, Fang Zhang, Catherine Corey, Ting-Ying Huang, Marie C. Bradley
|
08/24/2021 | |
No Differential Risk of Cutaneous Small Vessel Vasculitis with Oral Anticoagulant Use Among Patients with Atrial Fibrillation Presentation |
Presentation |
Adebola Ajao, Austin Cosgrove, Efe Eworuke, Mohamed Mohamoud, Rongmei Zhang, Oren Shapira, Joy Kolonoski, John Connolly
|
08/24/2021 | |
New Frontiers in Computable Phenotyping for Medical Product Safety Evaluation Presentation |
Presentation |
David S. Carrell
|
08/24/2021 | |
Comparing Outcomes in Trial-Eligible vs Real-World COVID-19 Patients: The Case of Invasive Mechanical Ventilation Presentation |
Presentation |
Ashley I. Martinez, Silvia Perez-Vilar, Mayura Shinde, Maria E. Kempner, Joy Kolonoski, Sarah K. Dutcher, Brian Kit
|
08/23/2021 | |
Early Uptake of New Molecular Entities Approved in 2017 in a Multisite National US Healthcare Data Network Presentation |
Presentation |
Andrew L. Simon, Sruthi Adimadhyam, Catherine Corey, Michael D. Nguyen
|
08/23/2021 | |
Outpatient-Identified COVID-19 and Subsequent Hospitalized Thrombotic Events Presentation |
Presentation |
Silvia Perez-Vilar
|
08/23/2021 | |
Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network: The Sentinel Distributed Database Mother-Infant Linkage Table Presentation |
Presentation |
Elizabeth A Suarez, Nicole Haug, Aaron Hansbury, Danijela Stojanovic, Catherine Corey
|
08/23/2021 | |
Pregnancy in Women with Heart Failure: A Cross-Sectional Study in the Sentinel Distributed Database Presentation |
Presentation |
Yan Li, Austin Cosgrove, Efe Eworuke, Catherine Corey, Joy Kolonoski, Mayura Shinde
|
08/23/2021 | |
How Under-Coded is Pediatric Hypertension?: Comparison of Claims and Electronic Health Record (EHR) Data Presentation |
Presentation |
Casie Horgan, Jillian Burk, Judith C. Maro, Efe Eworuke, Danijela Sojanovic, Jennifer Lyons, Brian Kit
|
08/23/2021 | |
Post-Keratoplasty Fungal Keratitis in the Sentinel Distributed Database: Prevalence and Time Trends Presentation |
Presentation |
Tancy C. Zhang, Sheryl A. Kluberg, Mayura Shinde, Dave Martin, Katherine Dea, Scott A. Brubaker, Brychan Clark, Christopher Jason, Cindy Ke Zhou, Joyce Obidi, Kinnera Chada, Azadeh Shoaibi, Hui-Lee Wong
|
08/23/2021 | |
Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: A Propensity Score Matched Case Study Presentation |
Presentation |
Elizabeth A Suarez, Michael Nguyen, Di Zhang, Yueqin Zhao, Danijela Stojanovic, Monica Munoz, Jane Liedtka, Abby Anderson, Wei Liu, Inna Dashevsky, David Cole, Sandra DeLuccia, Talia Menzin, Jennifer Noble, Judith C Maro
|
08/23/2021 | |
Statistical Power for Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use Presentation |
Presentation |
Elizabeth A Suarez, Michael Nguyen, Di Zhang, Yueqin Zhao, Danijela Stojanovic, Monica Munoz, Jane Liedtka, Abby Anderson, Wei Liu, Inna Dashevsky, Sandra DeLuccia, Talia Menzin, Jennifer Noble, Judith C Maro
|
08/23/2021 | |
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research Presentation |
Presentation |
Claire W. Rothschild, Sascha Dublin, Jeffrey S. Brown, Predrag Klasnja, Chayim Herzig-Marx, Juliane S. Reynolds, Zachary Wyner, Christina Chambers, David Martin
|
08/23/2021 | |
Who Gets Treated for Influenza: A Surveillance Study From the US Food and Drug Administration’s Sentinel System Publication |
Publication |
Noelle M. Cocoros, Nicole Haug, Austin Cosgrove, Catherine A. Panozzo, Alfred Sorbello, Henry Francis, Crystal Garcia, Robert Orr, Sengwee Toh, Sarah K. Dutcher, Gregory T. Measer
|
08/05/2021 | |
The Sentinel Experience Presentation |
Presentation |
Darren Toh
|
07/10/2021 | |
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research Publication |
Publication |
Claire W. Rothschild, Sascha Dublin, Jeffrey S. Brown, Predrag Klasnja, Chayim Herzig-Marx, Juliane S. Reynolds, Zachary Wyner, Christina Chambers, David Martin
|
07/03/2021 | |
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data Presentation |
Presentation |
Jennifer Lyons, Steven Bird, Danijela Stojanovic, Judith Maro, Darren Toh, Elnara Eynullayeva, Andrew Petrone, Rajani Rajbhandari
|
06/29/2021 | |
Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System Publication |
Publication |
Susan E. Andrade, Mayura Shinde, Tiffany A. Moore Simas, Steven T. Bird, Justin Bohn, Kevin Haynes, Lockwood G. Taylor, Julianne R. Lauring, Erin Longley, Cheryl N. McMahill-Walraven, Connie M. Trinacty, Cassandra Saphirak, Christopher Delude, Sandra DeLuccia, Tancy Zhang, David V. Cole, Nina DiNunzio, Autumn Gertz, Elnara Fazio-Eynullayeva, Danijela Stojanovic
|
06/04/2021 | |
Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin Publication |
Publication |
Efe Eworuke, Laura Hou, Rongmei Zhang, Hui-Lee Wong, Peter Waldron, Abby Anderson, Audrey Gassman, David Moeny, Ting-Ying Huang
|
05/20/2021 | |
Utilization of Hydroxyprogesterone Caproate among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database Publication |
Publication |
Mayura Shinde, Austin Cosgrove, Corinne M. Woods, Christina Chang, Christine P. Nguyen, David Moeny, Adebola Ajao, Joy Kolonoski, Huei-Ting Tsai
|
04/29/2021 | |
Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM Publication |
Publication |
Mara M. Epstein, Sarah K. Dutcher, Judith C. Maro, Cassandra Saphirak, Sandra DeLuccia, Muthalagu Ramanathan, Tejaswini Dhawale, Sonali Harchandani, Christopher Delude, Laura Hou, Autumn Gertz, Nina DiNunzio, Cheryl N. McMahill-Walraven, Mano S. Selvan, Justin Vigeant, David V. Cole, Kira Leishear, Jerry H. Gurwitz, Susan Andrade, Noelle M. Cocoros
|
04/26/2021 | |
Validity of ICD‐10‐CM Diagnoses to Identify Hospitalizations for Serious Infections Among Patients Treated With Biologic Therapies Publication |
Publication |
Vincent Lo Re III, Dena M. Carbonari, Jerry Jacob, William R. Short, Charles E. Leonard, Jennifer G. Lyons, Adee Kennedy, Jolene Damon, Nicole Haug, Esther H. Zhou, David J. Graham, Cheryl N. McMahill‐Walraven, Lauren E. Parlett, Vinit Nair, Mano Selvan, Yunping Zhou, Gaia Pocobelli, Judith C. Maro, Michael D. Nguyen
|
04/22/2021 | |
A COVID‐19‐Ready Public Health Surveillance System: The FDA's Sentinel System Publication |
Publication |
Noelle M. Cocoros, Candace C. Fuller, Sruthi Adimadhyam, Robert Ball, Jeffrey S. Brown, Gerald Dal Pan, Sheryl A. Kluberg, Vincent Lo Re 3rd, Judith Maro, Michael Nguyen, Robert Orr, Dianne Paraoan, Jonathan Perlin, Russell E. Poland, Meighan Rogers Driscoll, Kenneth Sands, Sengwee Toh, W. Katherine Yih, Richard Platt, and the FDA‐Sentinel COVID‐19 Working Group
|
04/02/2021 | |
Electronic Phenotyping of Health Outcomes of Interest Using a Linked Claims-Electronic Health Record Database: Findings from a Machine Learning Pilot Project Publication |
Publication |
Teresa B. Gibson, Michael D. Nguyen, Timothy Burrell, Frank Yoon, Jenna Wong, Sai Dharmarajan, Rita Ouellet-Hellstrom, Wei Hua, Yong Ma, Elande Baro, Sarah Bloemers, Cory Pack, Adee Kennedy, Sengwee Toh, Robert Ball
|
03/12/2021 | |
A General Propensity Score for Signal Identification using Tree-Based Scan Statistics Publication |
Publication |
Shirley V. Wang, Judith C. Maro, Joshua J. Gagne, Elisabetta Patorno, Sushama Kattinakere, Danijela Stojanovic, Efe Eworuke, Elande Baro, Rita Ouellet-Hellstrom, Michael Nguyen, Yong Ma, Inna Dashevsky, David Cole, Sandra DeLuccia, Aaron Hansbury, Ella Pestine, Martin Kulldorff
|
02/22/2021 | |
Community Building and Outreach Center (CBOC) Master Plan Publication |
Publication | 02/10/2021 | ||
Innovation Center (IC) Master Plan Publication |
Publication | 02/10/2021 | ||
Risk of Non-Melanoma Skin Cancer in Association with Use of Hydrochlorothiazide-Containing Products in the United States Publication |
Publication |
Efe Eworuke, Nicole Haug, Marie Bradley, Austin Cosgrove, Tancy Zhang, Elizabeth C. Dee, Sruthi Adimadhyam, Andrew Petrone, Hana Lee, Tiffany Woodworth, Sengwee Toh
|
02/04/2021 | |
Identification and Validation of Anaphylaxis Using Electronic Health Data in a Population-Based Setting Publication |
Publication |
Maralyssa A. Bann, David S. Carrell, Susan Gruber, Mayura Shinde, Robert Ball, Jennifer C. Nelson, James S. Floyd
|
02/02/2021 | |
Medical Chart Validation of Inpatient Diagnosis Codes for Transfusion‐Related Acute Lung Injury 2013‐2015 Publication |
Publication |
Candace C. Fuller, Vinod E. Nambudiri, Caren Spencer‐Smith, Lesley H. Curtis, Mayura Shinde, Austin Cosgrove, Margaret Johnson, Jason Hickok, Stacey Honda, Heba Ismail, Richard Max Kaufman, Adee Kennedy, Karla M. Miller, David J. Mohlman, Russell E. Poland, Robert Rosofsky, Kimberly Smith, Salim R. Surani, Meghan A. Baker
|
01/27/2021 | |
Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM Presentation |
Presentation |
Mara M. Epstein, Sarah K. Dutcher, Judith C. Maro, Cassandra Saphirak, Sandra DeLuccia, Muthalagu Ramanathan, Tejaswini Dhawale, Sonali Harchandani, Christopher Delude, Laura Hou, Autumn Gertz, Nina DiNunzio, Cheryl N. McMahill-Walraven, Mano S. Selvan, Justin Vigeant, David V. Cole, Kira Leishear, Jerry H. Gurwitz, Susan Andrade, Noelle M. Cocoros
|
12/15/2020 | |
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data Presentation |
Presentation |
Jennifer G. Lyons, Steven T. Bird, Judith C. Maro, Darren Toh, Elnara Fazio-Eynullayeva, Andrew Petrone, Rajani Rajbhandari, Lockwood Taylor
|
12/15/2020 | |
The FDA MyStudies App: A Reusable Platform for Distributed Clinical Trials and Real-World Evidence Studies Publication |
Publication |
Zachary Wyner, Sascha Dublin, Christina Chambers, Shyam Deval, Chayim Herzig-Marx, Shanthala Rao, Adam Rauch, Juliane Reynolds, Jeffrey S. Brown, David Martin
|
12/11/2020 | |
Validation of Claims-based Algorithms to Identify Hospitalized COVID-19 Events within the FDA Sentinel System Presentation |
Presentation |
Sheryl Kluberg, Sarah Dutcher, Laura Hou, Tancy Zhang, Adee Kennedy, Monica Ter-Minassian, Eric X. Watson, Sundeep S. Basra, Brian Kit, Monisha Billings, Robert Ball, Darren Toh, Noelle Cocoros
|
12/02/2020 | |
Incidence of Uterine Bleeding following Oral Anticoagulant Use in Food and Drug Administration’s Sentinel System Publication |
Publication |
Abby Anderson, Audrey Gassman, Laura Hou, Ting-Ying Huang, Efe Eworuke, David Moeny, Hui-Lee Wong
|
11/26/2020 | |
Antipsychotic Medication Use Among Hospitalized Infants Using Inpatient Data in FDA’s Sentinel System Presentation |
Presentation |
Mayura Shinde
|
11/17/2020 | |
Functional Clustering Methods for Longitudinal Data with Application to Electronic Health Records Publication |
Publication |
Bret Zeldow, James Flory, Alisa Stephens-Shields, Marsha Raebel, Jason A. Roy
|
11/11/2020 | |
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
|
11/05/2020 | |
Descriptive Assessment of Coagulopathy Among COVID-19 Patients: Feasibility Data Review Presentation |
Presentation |
Noelle Cocoros
|
10/27/2020 | |
Natural History of Coagulopathy in COVID-19 Presentation |
Presentation |
Vincent Lo Re
|
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 | |
Studying the Natural History of COVID-19: Risk of Arterial and Venous Thrombotic Events in the Sentinel System Presentation |
Presentation |
Vincent Lo Re
|
10/14/2020 | |
Leveraging the Sentinel System for COVID-19 Presentation |
Presentation |
Jeffrey Brown
|
10/14/2020 | |
When Decisions Can't Wait: Delivering Rapid Real World Studies Presentation |
Presentation |
Judith C. Maro, Simone Pinheiro
|
10/13/2020 | |
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 | |
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
|
09/23/2020 | |
Utilization of Sacubitril/Valsartan in Real-World Settings Presentation |
Presentation |
Efe Eworuke, Talia J. Menzin, Joy Kolonoski, Ting-Ying Huang
|
09/23/2020 | |
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
|
09/23/2020 | |
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
|
09/22/2020 | |
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
|
09/22/2020 | |
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
|
09/22/2020 | |
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
|
09/22/2020 | |
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
|
09/21/2020 | |
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
|
09/21/2020 | |
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
|
09/21/2020 | |
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
|
09/21/2020 | |
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
|
09/20/2020 | |
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
|
09/20/2020 | |
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
|
09/20/2020 | |
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
|
09/20/2020 | |
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
|
09/17/2020 | |
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
|
09/17/2020 | |
Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System Presentation |
Presentation |
Susan E. Andrade
|
09/17/2020 | |
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
|
09/17/2020 | |
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
|
09/17/2020 | |
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
|
09/17/2020 | |
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
|
09/17/2020 | |
Assessing Data Source Characteristics in Multi-site Analyses Presentation |
Presentation |
Jeffrey Brown
|
09/08/2020 | |
Utilization of Sacubitril/Valsartan in Real-World Settings Publication |
Publication |
Efe Eworuke, Talia J. Menzin, Emily C. Welch, Joy Kolonoski, Ting-Ying Huang
|
08/24/2020 | |
Defining COVID-19 Cohorts in Real-World Data Presentation |
Presentation |
Noelle Cocoros, Judith C. Maro, Jeff Brown
|
08/18/2020 | |
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
|
08/11/2020 | |
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 | |
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Focus on Endpoints Presentation |
Presentation |
Vincent Lo Re
|
08/04/2020 | |
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 | |
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Update on Methods Presentation |
Presentation |
Vincent Lo Re
|
07/14/2020 | |
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 | |
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Potential Aims/Methods Presentation |
Presentation |
Vincent Lo Re
|
06/23/2020 | |
Coagulopathy Assessment in Patients with COVID-19: A TriNetX Analysis Presentation |
Presentation |
Mayura Shinde
|
06/23/2020 | |
Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer Presentation |
Presentation |
Darren Toh
|
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 | |
Assessing Natural History, Drug Use and Treatment Impact for COVID-19 in the Sentinel System Presentation |
Presentation |
Robert Ball, Jennifer Stacey, Jeffrey S. Brown
|
05/13/2020 | |
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 |
Darren Toh
|
03/05/2020 | |
Sentinel Mother-Infant Linkage and Pregnancy Analyses Presentation |
Presentation |
Elizabeth Suarez
|
02/19/2020 | |
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 |
Qoua L. Her
|
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 | |
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
|
11/14/2019 | |
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 | |
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
|
08/27/2019 | |
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
|
08/27/2019 | |
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
|
08/27/2019 | |
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
|
08/27/2019 | |
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
|
08/27/2019 | |
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
|
08/27/2019 | |
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
|
08/26/2019 | |
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
|
08/26/2019 | |
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
|
08/26/2019 | |
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
|
08/26/2019 | |
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
|
08/25/2019 | |
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
|
08/25/2019 | |
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
|
08/25/2019 | |
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
|
08/25/2019 | |
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
|
08/25/2019 | |
Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings Presentation |
Presentation |
Marie Bradley
|
08/25/2019 | |
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
|
08/25/2019 | |
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
|
08/25/2019 | |
Experience from US FDA Sentinel Initiative Studies Presentation |
Presentation |
Darren Toh
|
08/25/2019 | |
Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis Presentation |
Presentation |
Christian Hampp
|
08/25/2019 | |
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 |
Darren Toh
|
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 |
Susan Andrade
|
11/30/2018 | |
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 | |
Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App Presentation |
Presentation |
David Martin
|
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 |
Zachary Wyner
|
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 |
Jeffrey Brown
|
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 | |
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
|
08/25/2018 | |
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
|
08/24/2018 | |
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
|
08/22/2018 | |
Using Time-Dependent Propensity Scores to Correct for Differential Depletion of Susceptibles when Estimating Hazard Ratios in Time-to-Event Data Presentation |
Presentation |
Richard Wyss
|
08/22/2018 | |
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
|
08/22/2018 | |
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
|
08/22/2018 | |
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
|
08/21/2018 | |
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
|
08/21/2018 | |
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
|
08/21/2018 | |
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
|
08/21/2018 | |
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
|
08/21/2018 | |
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
|
08/21/2018 | |
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
|
08/21/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
Data-Mining for Adverse Events Using the Self-Controlled Tree-Temporal Scan Statistic Presentation |
Presentation |
Katherine Yih
|
08/20/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
Sequential and SequentialDesign: Tools For Prospective Sequential Medical Product Safety Surveillance Presentation |
Presentation |
Judith C. Maro, Efe Eworuke, Andreia Leite, Martin Kulldorff
|
08/20/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
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
|
08/20/2018 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 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 |
Rima Izem PhD
|
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 | |
Promises and Challenges of Screening for Adverse Events in Sentinel Presentation |
Presentation |
Michael Nguyen
|
08/27/2017 | |
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
|
08/25/2017 | |
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 | |
Evaluation of Case-Finding Algorithm for Venous Thromboembolism Outcome Presentation |
Presentation |
Megan Reidy, Jill L.O. de Jong, Lauren Zichittella, W. Katherine Yih
|
08/25/2017 | |
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
|
08/25/2017 | |
Using the Self-Controlled Risk Interval (SCRI) Method to Study Vaccine Safety Presentation |
Presentation |
Katherine Yih
|
08/25/2017 | |
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 | |
Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth Presentation |
Presentation |
Efe Eworuke
|
08/25/2017 | |
Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System Presentation |
Presentation |
Genna Panucci
|
08/25/2017 | |
Impact of ICD-10-CM Transition on Selected Cardiovascular-Related Events in the Sentinel System Presentation |
Presentation |
Tiffany Siu Woodworth
|
08/25/2017 | |
TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance Presentation |
Presentation |
Judith Maro, Rima Izem, Martin Kulldorff, Azadeh Shoaibi
|
08/25/2017 | |
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
|
08/25/2017 | |
Identification of Name Confusion Medication Errors in the US FDA's Sentinel System Presentation |
Presentation |
Noelle Cocoros
|
08/25/2017 | |
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
|
08/25/2017 | |
Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database Presentation |
Presentation |
Richard Scott Swain
|
08/25/2017 | |
Evaluation of Test Data in Distributed Research Networks: A Sentinel System Example Presentation |
Presentation |
Emily C. Welch
|
08/25/2017 | |
Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System Presentation |
Presentation |
Noelle Cocoros
|
08/25/2017 | |
Dispensings of Influenza Antiviral Medications in the Sentinel System as a Source of Data for Influenza Surveillance Presentation |
Presentation |
Noelle Cocoros
|
08/25/2017 | |
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
|
08/25/2017 | |
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
|
08/25/2017 | |
Listening to Patient Voices in Pharmacoepidemiological Research - Opportunities for Innovation and Inclusion Presentation |
Presentation |
Wendy Camello Castillo
|
08/25/2017 | |
Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System Presentation |
Presentation |
Elizabeth Chrischilles
|
08/25/2017 | |
Developing a Mother-Infant Cohort in Sentinel's PRISM Program as a Resource to Monitor the Safety of Vaccine Use During Pregnancy Presentation |
Presentation |
Alison Kawai
|
08/25/2017 | |
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 | |
Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database Presentation |
Presentation |
Crystal Garcia
|
08/25/2017 | |
Medical Product and Performance Evaluation Programs Using Distributed Data Sources Presentation |
Presentation |
Richard Platt MD, Robert Ball
|
08/24/2017 | |
Developing a Mobile App for Studies of Medication Safety Presentation |
Presentation |
Sascha Dublin
|
08/24/2017 | |
Randomized Clinical Trial Using FDA's Sentinel Infrastructure: An Analysis Assessing Feasibility Presentation |
Presentation |
Noelle Cocoros on behalf of Crystal Garcia
|
08/24/2017 | |
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 |
Laura Hou
|
08/23/2017 | |
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 | |
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
|
08/24/2016 | |
Assessment of the US Food and Drug Administration’s Sentinel Analysis Tools: Angiotensin-Converting Enzyme Inhibitors and Angioedema Presentation |
Presentation |
Joshua Gagne
|
08/23/2016 | |
Ondasetron Use Among Pregnancies Identified in the Sentinel Distributed Database Presentation |
Presentation |
Lockwood G. Taylor
|
08/23/2016 | |
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
|
08/23/2016 | |
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
|
08/23/2016 | |
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
|
08/23/2016 | |
Assessing Quadrivalent HPV Vaccine Safety using the Self-Controlled Tree-Temporal Scan Statistic Presentation |
Presentation |
Martin Kulldorff, Katherine Yih
|
08/23/2016 | |
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
|
08/23/2016 | |
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
|
08/23/2016 | |
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
|
08/23/2016 | |
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
|
08/23/2016 | |
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
|
08/23/2016 | |
ICD-10-CM: Is Sentinel Ready? Presentation |
Presentation |
Darren Toh
|
08/23/2016 | |
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 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 | |
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 | |
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 | |
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
|
08/27/2013 | |
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 | |
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
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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
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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
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01/19/2012 | |
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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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 | |
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
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02/10/2011 |