食物过敏临床试验的常见数据要素:综述。

IF 3 4区 医学 Q2 ALLERGY
Shruti Sehgal, Justin Starren, Kyle Cattin, Lucy Bilaver, Anupama Gururaj, Alkis Togias, Ruchi S Gupta
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引用次数: 0

摘要

综述目的:食物过敏是一个主要的公共卫生问题,影响了美国约8%的儿童和11%的成年人。该领域的研究迅速扩大,但由于缺乏标准化的数据字段或通用数据元素(CDEs)来记录食物过敏数据,因此受到限制。本文综述了食物过敏的CDEs研究的必要性和预期影响,并介绍了CDEs的核心原则。最新发现:数据定义的标准化和一项研究和跨多项研究数据收集的一致性是临床研究的基本原则。NIH的几个中心一直在合作支持CDEs的开发,从而促进临床研究的FAIR原则。摘要:在缺乏一种标准化的语言来记录食物过敏临床研究数据的情况下,食物过敏的人口健康负担继续上升。国家和全球都需要制定和实施食物过敏CDEs,以便更好地了解和减轻这种免疫介导疾病的负担。如果采用这些CDEs,不仅可以提高数据的一致性和互操作性,还可以加快和提高未来食物过敏临床试验的质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Common data elements for food allergy clinical trials: an overview.

Purpose of review: Food allergy represents a major public health issue, affecting about 8% of children and 11% of adults in the United States. Research in the field has rapidly expanded but is limited by a lack of standardized data fields or common data elements (CDEs) to record food allergy data. The present review focuses on the need for developing CDEs for food allergy, and their anticipated impact, as well as describes the central tenets of CDEs.

Recent findings: Standardization of data definitions and consistency in data collection within a study and across multiple studies is a fundamental principle of clinical research. Several NIH centers have been collaborating to support the development of CDEs, thereby promoting the FAIR principles for clinical research.

Summary: The population health burden of food allergies continues to rise in the absence of a standardized language for documenting food allergy clinical research data. Development and implementation of food allergy CDEs is needed both nationally and globally, to better understand and reduce the burden of this immune-mediated disease. When adopted, these CDEs will not only improve data consistency and interoperability but also speed up and improve the quality of future food allergy clinical trials.

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来源期刊
CiteScore
5.90
自引率
3.60%
发文量
109
审稿时长
6-12 weeks
期刊介绍: This reader-friendly, bimonthly resource provides a powerful, broad-based perspective on the most important advances from throughout the world literature. Featuring renowned guest editors and focusing exclusively on one to three topics, every issue of Current Opinion in Allergy and Clinical Immunology delivers unvarnished, expert assessments of developments from the previous year. Insightful editorials and on-the-mark invited reviews cover key subjects such as upper airway disease; mechanisms of allergy and adult asthma; paediatric asthma and development of atopy; food and drug allergies; and immunotherapy.
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