Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angioensin-Converting Enzyme (ACE) Inhibitors versus Beta-blockers

Project Title Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angioensin-Converting Enzyme (ACE) Inhibitors versus Beta-blockers
Date Posted
Sunday, January 31, 2016
Status
In progress
Deliverables
Description

This statistical methods project is one of four workgroups that used exposure/outcome pairs with known positive associations to test Mini-Sentinel (now Sentinel) routine querying tools. Specifically, these known positive associations tested the Cohort Identification and Descriptive Analysis (CIDA) tool in combination with the Propensity Score Analysis (PSA) tool.

This known positive test case assessed ACE inhibitors versus beta-blockers and risk of angioedema. The CIDA tool was used to identify new users of these medications. Information generated by the CIDA tool was used by the PSM tool to match cohort members based on propensity score. Propensity scores were calculated using a list of user-defined covariates. One run of the program was required. The time window was January 1st, 2008 to September 30th, 2013.

Workgroup Members

Patrick Archdeacon MD; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Ryan Carnahan PharmD, MS, BCPP; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA

Elizabeth Chrischilles MS, PhD; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA

April Duddy MS; Candace Fuller PhD; Hannah Katcoff MPH; Jennifer R. Popovic DVM, MA; Darren Toh ScD; Tiffany S. Woodworth MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

Joshua Gagne PharmD, ScD; Sebastian Schneeweiss MD, ScD; Shirley V. Wang PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

Xu Han PharmD, PhD, MS; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Sean Hennessy PharmD, PhD; Charles E. Leonard PharmD, MSCE; Center for Clinical Epidemiology and Biostatistics and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Jie Li PhD, MBBS; Marsha Reichman PhD; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Tamra E. Meyer PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Medical Product
angiotensin-converting enzyme (ACE) inhibitor
beta blocker
Health Outcome
angioedema
Population / Cohort
All individuals
Time Period
January 1, 2008 - September 30, 2013
Data Sources
Mini-Sentinel Distributed Database (MSDD)
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