TreeScan in Pregnancy

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Details

Basic Details

Date Posted:

Friday, June 19, 2020

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:

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.
Develop a general propensity score for pregnant women.
Develop tree of infant outcomes in ICD-10-CM and develop tree of maternal outcomes in ICD-10-CM.

Aim 2:

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.
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:

Assess the performance of TreeScan to detect maternal outcomes using empirical data among pregnant women with live birth outcomes.
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.

The Sentinel Operations Center posted this final draft protocol 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 log of changes is included in the revised protocol (v2).

Deliverable(s) (2)

Use of the Tree-Based Scan Statistic for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: Protocol

Use of the Tree-Based Scan Statistic for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: Appendices

Additional Information

Information

Population / Cohort:

Mothers and infants

Data Source(s):

IBM® MarketScan® Research Databases

Contributors

Workgroup Leader(s):

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

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

Workgroup Member(s):

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

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

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

Abby Anderson, MD; Division of Urology, Obstetrics and Gynecology, 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

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Methods, Data, & Tools

TreeScan in Pregnancy

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