TreeScan in Pregnancy

Basic Details
Date Posted
Wednesday, July 14, 2021
Status
In progress
Health Outcome(s)
infant outcomes
maternal outcomes
Description

The goals of this methods project are to evaluate the performance of TreeScan to assess maternal and infant outcomes, test signal identification methods in a pregnancy setting, and evaluate methods performance using older drugs with relatively well-characterized safety profiles.

A Propensity Score-Based TreeScan approach will be the primary analysis for this project. There will be two analyses: 1) empirical (real) data set and a 2) simulated data set with investigator-inserted risks. Two protocols will be written for Aims 2 and 3, respectively, and posted for public comment.

Aim 1:

  • a) Develop a mother-infant linkage programming module, to be executed in IBM® MarketScan® Research Databases, that produces an SCDM-compliant mother-infant linkage table using a published method.
  • b) Develop a general propensity score for pregnant women.
  • c) Develop tree of infant outcomes in ICD-10-CM and develop tree of maternal outcomes in ICD-10-CM.  

Aim 2:

  • a) Assess the performance of TreeScan to detect infant outcomes using empirical data with the following outcomes: congenital malformations as the primary objective and a selection of additional outcomes including small for gestation age, low birth weight, and increased rate of premature birth as the secondary objectives.
  • b) Perform a simulation study with investigator-injected risks to develop data on the power to detect risk under ideal circumstances, using empirical data to develop background rates. 

Aim 3:

  • a) Assess the performance of TreeScan to detect maternal outcomes using empirical data among pregnant women with live birth outcomes.
  • b) Perform a simulation study with investigator-injected risks to develop data on the power to detect risk under ideal circumstances, using empirical data to develop background rates.

This infant outcomes protocol was posted for public comment from June 19, 2020 through July 6, 2020. The public comment period is now closed. A revised version was approved for implementation by FDA on August 17, 2020. A second revised version was approved for implementation by FDA on February 9, 2021. A log of changes is included in the revised protocol (v3).

This maternal outcomes protocol was posted for public comment from June 29, 2021 through July 13, 2021. The public comment period is now closed. Any revisions done to this protocol following the public comment period will be noted in the change log document included in the amended protocol. Posting of the revised document will be listed on the Sentinel homepage, on the relevant assessments project details page, and in the Sentinel RSS feed.

Information
Population / Cohort
Mothers, infants
Data Source(s)
IBM® MarketScan® Research Databases
Workgroup Leader(s)

Judith C. Maro, PhD, Elizabeth Suarez, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Danijela Stojanovic, PharmD, PhD; Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Member(s)

David Cole; Inna Dashevsky, MS; Sandra DeLuccia, MPH; Talia Menzin, MS; Jennifer Noble; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Thuy N. Thai, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL

Almut G. Winterstein, PhD, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy; Center for Drug Evaluation and Safety; Department of Epidemiology, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL

Monica Munoz, PharmD, PhD; Division of Pharmacovigilance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Michael Nguyen, MD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 

Abby Anderson, MD; Division of Bone, Reproductive, and Urologic Products, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD 

Steven Bird, PharmD, PhD; Division of Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Yueqin Zho, PhD; Di Zhang, PhD; Office of Biostatistics, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Jane Liedtka, MD; Division of Pediatric and Maternal Health, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Wei Liu, PhD; Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD