Evaluation of Tuberculosis Diagnostics in Children: 1. Proposed Clinical Case Definitions for Classification of Intrathoracic Tuberculosis Disease. Consensus From an Expert Panel
Evaluation of Tuberculosis Diagnostics in Children: 1. Proposed Clinical Case Definitions for Classification of Intrathoracic Tuberculosis Disease. Consensus From an Expert Panel
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DOI：
10.1093/infdis/jis008
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发表时间：
2012-05-15
影响因子：
6.4
通讯作者：
Wingfield, Claire
中科院分区：
文献类型：
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作者：
Graham, Stephen M.;Ahmed, Tahmeed;Wingfield, Claire
迫切需要改进儿童结核病的诊断，特别是患有胸腔内疾病的幼儿，因为这是儿童结核病最常见的类型，也是最大的诊断挑战。还需要标准化的临床病例定义，用于前瞻性临床研究中的诊断评估，其中包括怀疑患有结核病但未通过结核分枝杆菌培养证实的儿童。一个代表广泛专业知识和儿童结核病研究经验的小组旨在制定儿童胸内结核病的标准化临床研究病例定义，以便能够对儿科人群中的新结核病诊断技术进行统一评估。定义和声明草案已被提出并广泛分发以征求反馈。然后，专家小组审议了每项拟议的定义和与临床定义相关的陈述。建立了正式的群体共识规则，并对每项声明达成了共识。本文中提出的定义旨在用于临床研究以评估诊断测定，而不是用于个体患者的诊断或治疗决策。一篇补充文章讨论了疑似结核病儿童诊断研究中需要考虑的方法学问题。
There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.