# FORWARD Common Data Elements Supplement (CDE)

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2024 · $465,884

## Abstract

PROJECT SUMMARY/ABSTRACT
Food allergy (FA) is a potentially life-threatening condition that affects 8% of children in the United States.
Although racial and ethnic differences in the prevalence and severity of other atopic conditions such as
asthma and eczema have been well described, little is known about differences in FA. Black and Hispanic
children may have worse clinical outcomes than their White counterparts. Less is known about FA among
Asian populations in the US. Phenotypic and endotypic differences, including rates of sensitization and co-
morbidities are currently examined. Data on racial differences in FA management practices, especially as
children enter adolescence are incomplete. Families with food-allergic children may experience impaired
psychosocial outcomes, however, these data come primarily from White, privately insured families.
The goal of the parent R01 FORWARD award is to:
 1) Determine factors associated with differences in the development of tolerance and new FAs,
 2) Determine differences in FA management and outcomes during adolescence, and
 3) Identify phenotypic and endotypic differences in FA.
Multi-site data integration has lacked standardization as the FORWARD study relies on manual and electronic
data extraction. While electronic data extraction is more scalable, this approach has not been implemented at
all FORWARD sites and is limited by variation in underlying documentation approaches. This systematic
limitation has highlighted the need for the rigorous development of common data elements to advance the
goals of the FORWARD study. Currently, we are working with FA domain experts to develop a set of CDEs for
FA to standardize the way FA data is collected across multiple studies.
The supplement proposes to leverage ongoing common data elements (CDE) work to support the FORWARD
project’s prospective data collection for the remaining 3 years and beyond by accomplishing the following aims:
Aim 1: We will implement FA CDEs for data collection in a multicenter, prospective, observational study.
Aim 2: We will build on our ongoing FA CDE work and continue to develop a set of CDEs that can help provide
consistency in the way FA data are collected in FORWARD and beyond.
This project is fully within the scope of the FORWARD project’s aims regarding an understanding of the
development of clinical immune tolerance and new FAs as well as FA management and psychosocial
outcomes during two stages of development (middle childhood: ages 6-11 and adolescence: ages 12-18).
To accomplish study aims, CDEs related to “patient attributes” and “healthcare utilization and psycho-social
outcomes” domains will be implemented into surveys. An expert panel will be divided into workgroups and
tasked with defining each CDE including a structured set of responses to ensure consistent data collection.
Additional Delphi cycles will be executed within workgroups for the selection of individual value-set items.

## Key facts

- **NIH application ID:** 11128201
- **Project number:** 3R01AI130348-08S2
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Ruchi S Gupta
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $465,884
- **Award type:** 3
- **Project period:** 2017-05-11 → 2027-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11128201

## Citation

> US National Institutes of Health, RePORTER application 11128201, FORWARD Common Data Elements Supplement (CDE) (3R01AI130348-08S2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11128201. Licensed CC0.

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