Validation of Stillbirth in ICD-10-CM Post-Hoc Analyses

Basic Details
Date Posted
Wednesday, June 3, 2020
Status
Complete
Health Outcome(s)
stillbirth
Study Type
Validations Supported by Traditional Medical Chart Review
Description

The FDA is interested in identifying other codes in the PEPR claims profiles from the Stillbirth Validation project and evaluate whether they can inform further refinement of the algorithm used in that project.  

Aim 1: Evaluate the distribution of individual codes among confirmed and non-confirmed stillbirth cases to inform further refinement of the algorithm using the PEPR claims profiles of potential cases created as part of the Stillbirth Validation project  

Aim 2. Identify potential additional variables to inform further refinement of the algorithm using the PEPR claims profiles of Stillbirth cases, examine predictors of stillbirth and determine the PPVs for specific combinations of codes previously created and new variables

Additional Information
Time Period
July 2018 - December 2019
Population / Cohort
Females aged 12-55 years
Workgroup Leader(s)

Susan E. Andrade, ScD; Meyers Primary Care Institute, (Fallon Health, Reliant Medical Group, and University of Massachusetts Medical School), Worcester, MA

Workgroup Member(s)

Mayura Shinde, PhD; Sandra DeLuccia, MPH; Inna Dashevsky, MS; Robert Jin, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Julianne Lauring, MD; Timothy Konola; Cassandra Saphirak, MA; Meyers Primary Care Institute, (Fallon Health, Reliant Medical Group, and University of Massachusetts Medical School), Worcester, MA 

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

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