FORWARD Common Data Elements Supplement (CDE)

NIH RePORTER · NIH · R01 · $465,884 · view on reporter.nih.gov ↗

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
NORTHWESTERN UNIVERSITY
Principal Investigator
Ruchi S Gupta
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$465,884
Award type
3
Project period
2017-05-11 → 2027-04-30