FORWARD Supplement: Common Data Elements for Food Allergy

点击翻译按钮获取中文摘要

Food allergy is one of the most common immune-mediated conditions impacting 8% of children and 10% of adults in the US accounting for approximately 32 million Americans. Despite the massive clinical and economic impact of food allergy (FA), our ability to disentangle the many facets of the condition is limited by the lack of established common data elements (CDE). For example, even though clinicaltrials.gov lists over 500 FA studies (76 actively recruiting), the coverage of FA in the National Institutes of Health (NIH) CDE repository is minimal thus limiting the ability of investigators to compare results across interventional and observational studies. FORWARD is a multi-site study that systematically investigates racial and ethnic disparities between Black, White, and Hispanic/Latino children with FA in clinical and psychosocial outcomes, FA phenotypes and endotypes, and FA management practices. This supplement proposes to define CDEs using a rigorous consensus-based process that will increase the impact of the data analyses stemming from the FORWARD study. The FORWARD team of investigators in four sites will collaborate with experts from other academic institutions, as well as additional experts recommended by the National Institute of Allergy and Infectious Diseases (NIAID). Building on our prior FA Data Dictionary work, we propose to identify and develop a set of CDEs that can help provide consistency in the way FA clinical and research data are collected in FORWARD and beyond. Both FA diagnostics and therapies are evolving rapidly. Currently, our ability to compare various new therapies is limited by the lack of standardized data across studies. Development of FA CDEs will not only improve the consistency and interoperability of data in FORWARD, but also increase the speed and quality of future FA clinical trials to advance the understanding of this immune- mediated condition. Given the high prevalence of FA, and the impact on quality of life, accurate and reproducible collection of FA data can be of value to many other NIH’s institutes and centers, including the NIH Clinical Center.