Department of Global Health, Academic Medical Center; and Amsterdam Institute of Global Health and Development, Amsterdam, the Netherlands.
J Infect Dis. 2012 May 15;205 Suppl 2:S191-8. doi: 10.1093/infdis/jis188. Epub 2012 Apr 3.
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.
最近,一些新的结核病检测和耐药性检测诊断工具已经问世。世界卫生组织(WHO)采用推荐评估、制定与评价(GRADE)分级过程来认可新的结核病诊断方法。在检测准确性以外的有限证据情况下,就会进行这种认可过程。结核病规划需要获得指导,了解应扩大使用哪些新的诊断方法,以及如何在诊断算法中最佳定位这些方法。为了加快采用新的结核病诊断方法,应修改政策建议流程,包括 2 个步骤:技术建议和方案建议。技术建议将遵循 GRADE 流程,并基于准确性,同时考虑有限的成本和可行性数据,而方案建议将包括患者重要结局、在常规条件下实施的成本效益,以及对成功扩大规模至关重要的因素。这两个步骤的证据都应系统收集,但每个步骤都需要不同的研究设计。
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