FORWARD Supplement: Common Data Elements for Food Allergy

食物过敏是影响8%儿童的最常见的免疫调节疾病之一 美国10%的成年人约占3200万美国人。尽管 食物过敏(FA)的巨大临床和经济影响，我们将许多 这种情况的方方面面受到缺乏已建立的公共数据元素(CDE)的限制。为 例如，尽管Clinicaltrials.gov列出了500多项FA研究(76项正在招募)，但 美国国立卫生研究院(NIH)CDE库中FA的覆盖面很小，因此限制了 研究人员比较干预性研究和观察性研究结果的能力。 Forward是一项多地点研究，系统地调查种族和民族差异 黑人、白人和西班牙裔/拉丁裔儿童FA的临床和心理社会研究 结果，FA表型和内型，以及FA管理实践。本副刊 建议使用严格的基于共识的流程来定义CDE，这将增加影响 来自前瞻性研究的数据分析。前线调查组 将与来自其他学术机构的专家以及其他 国家过敏和传染病研究所(NIAID)推荐的专家。 在我们之前的FA数据字典工作的基础上，我们建议识别和开发一组CDE 这有助于在收集FA临床和研究数据的方式上提供一致性 向前和超越。 FA的诊断和治疗都在迅速发展。目前，我们能够比较不同的 由于缺乏跨研究的标准化数据，新疗法受到限制。FA CDE的发展 不仅会提高数据在转发时的一致性和互操作性，而且还会增加 未来FA临床试验的速度和质量，以促进对这种免疫- 调解状态。鉴于FA的高患病率，以及对生活质量的影响，准确 可重复收集的FA数据对NIH的许多其他研究所和中心都有价值， 包括美国国立卫生研究院临床中心。

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.