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Biostatistics Core Studies


Particulate Air Pollution, Cardiovascular Events, and Susceptibility Factors (PACES)

This is a retrospective cohort study of 5 million adult members of Kaiser Permanente Northern California during 2000 to 2012, linked to state-of-the-art estimates of exposure to PM2.5 (particulate matter less than 2.5 micrometers in diameter) generated at...
Funder: National Institute of Environmental Health Sciences
Investigator: Alexeeff, Stacey

Study on the Association of Uterine Perforation and IUD expulsion With Breastfeeding Status at the Time of IUD insertion and Postpartum Timing of IUD Insertion in Electronic Medical Record Databases - A Post-marketing Requirement for Mirena

The Food and Drug Administration (FDA) has required Bayer AG to conduct a post-marketing study in the U.S. to determine the incidence of uterine perforation and IUD expulsion by type of intrauterine device (IUD) used. The goal of this study is to quantify...
Funder: Bayer AG
Investigator: Armstrong, Mary Anne

Mini-Sentinel Efforts to Develop the Sentinel Initiative: The Use of Propensity-Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring

Mini-Sentinel Task Order
Funder: U.S. Food and Drug Administration
Investigator: Fireman, Bruce

Feasibility and Performance Assessments of TMLE and hdPS Methodologies to Fit MSM in a Real-World CER Study

This study aims to evaluate the practicability and practical advantages of: 1) Targeted Minimum Loss based Estimation (TMLE), and 2) a high-dimensional propensity score (hdPS) algorithm to fit dynamic Marginal Structural Models (MSM) in a longitudinal...
Funder: Agency for Healthcare Research and Quality
Investigator: Neugebauer, Romain

Software to Automate Implementation of Causal Inference Methods with Time-Varying Interventions

This project aims to develop SAS macros to automate the data structuring required for implementation of Causal Inference methods with electronic health records data in studies with time-varying exposures, confounding and selection bias (e.g., marginal str...
Investigator: Neugebauer, Romain

M-S Evaluating the Performance of Mini-Sentinel Analytic Modules Using Simulation Experiments

Funder: U.S. Food and Drug Administration
Investigator: Fireman, Bruce

Risk of Uterine Perforation among Women Using different types of IUDs and the Association with Timing of Insertion and Breastfeeding

The goal of the study is to compare the incidence of uterine perforation within 12 months after IUD insertion between: (1) postpartum insertions within 12 months of delivery (with breastfeeding status), (2) post abortion or pregnancy loss IUD insertio...
Funder: Bayer AG
Investigator: Armstrong, Mary Anne

A Database Cohort Study to Assess the Risk of Developing non-Melanoma Skin Cancer in Adult Patients with Atopic Dermatitis Exposed to Topical Calcineurin Inhibitor

The primary objective of this study is to assess the long-term risk of developing melanoma in adult subjects aged 40 years with AD exposed to topical calcinuerin inhibitors (TCIs). To accomplish this objective, the long-term risk of developing melanoma w...
Funder: Valeant Pharmaceuticals International, Inc.
Investigator: Quesenberry, Charles

Causal Analyses of Electronic Health Record Data for Assessing the Comparative Effectiveness of Treatment Regimens

This study aims to strengthen causal inferences based on Marginal Structural Modeling (MSM) and large healthcare databases for Comparative Effectiveness Research in Type 2 Diabetes Mellitus (T2DM), specifically, it aims to: 1) Develop a consensus for...
Funder: Patient-Centered Outcomes Research Institute
Investigator: Neugebauer, Romain