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