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Validation of Serious Infections among an Immunocompromised Population

Basic Details
Date Posted
Status
Complete
Health Outcome(s)
serious infection
Study Type
Validations Supported by Traditional Medical Chart Review
Description

As part of the Health Outcomes of Interest (HOI) series of projects, this project aims to:

  1. develop and test electronic algorithms for identifying cases of serious infection in the Sentinel Distributed Database using the Cohort Identification and Descriptive Analysis (CIDA) tool
  2. develop a sampling strategy across participating Data Partners to retrieve the full-text medical records for up to 250 likely serious infection cases and to retrieve the corresponding Patient Episode Profiles for the same cases
  3. develop and test an abstraction and adjudication form for serious infections
  4. conduct medical chart abstraction and adjudication for up to 250 electronically-identified serious infection cases both via their medical records and their patient profiles
  5. summarize the validation and adjudication activities and results
  6. develop the structure of a prototype ancillary data table to capture validation metadata
Additional Information
Time Period
November 2017 - November 2019
Data Source(s)
Sentinel Distributed Database (SDD)
Related Link(s)
Serious Infections among Immunocompromised Health Plan Members
Validity of ICD‐10‐CM Diagnoses to Identify Hospitalizations for Serious Infections Among Patients Treated With Biologic Therapies
Workgroup Leader(s)

Vincent Lo Re MD, MSCE; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA

Workgroup Member(s)

Dena Carbonari MS; Jerry Jacob MD, MSc; Charles E. Leonard PharmD, MSCE; William R. Short MD, MPH; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA

Sarah Dutcher PhD; Office of Research and Standards/Office of Generic Drugs, 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

Sandra Feibelmann MPH; Autumn Gertz; Nicole Haug MPH; Adee Kennedy MS, MPH; Jennifer Lyons PhD; Judith Maro PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA