Which New Diagnostics for Tuberculosis, and When?
Which New Diagnostics for Tuberculosis, and When?
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DOI：
10.1093/infdis/jis188
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发表时间：
2012-05-15
影响因子：
6.4
通讯作者：
Kimerling, Michael E.
中科院分区：
文献类型：
--
作者：
Cobelens, Frank;van den Hof, Susan;Kimerling, Michael E.
最近，用于结核病检测和耐药性检测的新诊断工具已经出现。世界卫生组织通过使用建议评估、发展和评估(等级)程序来支持新的结核病诊断方法。这一认可过程发生在测试准确性之外的证据有限的情况下。有必要为结核病项目提供指导，指导哪些新的诊断方法应该扩大规模，以及如何最好地将它们放在诊断算法中。为了加速采用新的结核病诊断方法，政策建议过程应修订为包括两个步骤：技术建议和方案建议。技术建议将遵循分级程序，并以有限的成本和可行性数据的准确性为基础，而方案建议将包括患者重要的结果、在常规条件下实施时的成本效益以及成功扩大规模的关键因素。应该系统地收集这两个步骤的证据，但每个步骤都需要不同的研究设计。
Recently, new diagnostic tools for tuberculosis detection and resistance testing have become available. The World Health Organization endorses new tuberculosis diagnostics by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. This endorsement process takes place when limited evidence beyond test accuracy is available. There is a need to provide guidance to tuberculosis programs about which new diagnostics to scale up and how best to position them in diagnostic algorithms. To speed adoption of new diagnostics for tuberculosis, the policy recommendation process should be revised to consist of 2 steps: technical recommendation and programmatic recommendation. Technical recommendation would follow the GRADE process and be based on accuracy with limited cost and feasibility data, while programmatic recommendation would include patient-important outcomes, cost-effectiveness when implemented under routine conditions, and factors critical to successful scale-up. The evidence for both steps should be systematically collected, but each requires different study designs.