抽象的
世界卫生组织耐药性结核病指南应明确区分证据,专家意见和假设,以允许对建议的不确定性欣赏http://bit.ly/2FHxmyW
To the Editor:
自2011年以来,世界卫生组织(WHO)已使用建议评估,开发和评估(等级)系统的评分来评估证据质量[1,2]更新耐药性结核病管理指南(DR-TB)。与以前的准则相比,这是对基于证据的建议的不可否认的改进,这些指南主要基于专家意见[3]。但是,指南发展的某些方面尚不清楚。我们认为,2019年世界卫生组织合并了DR-TB治疗指南[4]从评估的证据中提出建议的方式提出了一些问题,以回答特定的PICO(患者,干预,比较者,结果)问题。
Firstly, the evidence that was graded to assess the standardised shorter multidrug-resistant tuberculosis regimen (SCR) (PICO 1) used the 2011 [5] or 2016 [6,7] WHO longer regimens as a comparator. This does not provide conclusive evidence on the performance of the SCR as compared to the new longer regimens that include new core drugs, such as bedaquiline and linezolid, as recommended by the 2019 WHO guideline. Similarly, the phase III trial STREAM, which tested the SCR regimen, did not include these drugs in the control arm [8]。Therefore, the recommendation of the SCR as an equal alternative to the longer regimen designed according to 2019 guidelines is based on no direct evidence.
Secondly, the analyses conducted on patients treated with the 2016 WHO longer regimen do not inform about the optimal number of drugs and the duration of the newly recommended regimen (PICO 3 and PICO 4, 5 and 6). Moreover, assessing treatment duration from retrospective observational studies, as conducted for the individual patient data meta-analysis [9]例如,在分析中排除了死亡和失去随访的死亡和患者,可能会导致提出固有偏见的建议。基于这些发现的任何建议都将受益于作为推断和专家意见的提出。与可用的观察报告相比,这也适用于6个月后常规停止Bedaquiline治疗的建议[10,11], and inconsistent with the recommendation to use other drugs (例如linezolid) for a longer duration than in their approved labelling.
Thirdly, the 2019 guidelines follow the assumption that the combination of the most effective drugs (three group A and one group B), as identified by the individual patient data meta-analysis (PICO 2), would result in the most effective longer regimen. Conversely, a similar assumption has not been made for the SCR, a regimen that excludes two of the most potent group A drugs (linezolid and bedaquiline). Furthermore, an exception was made to this second assumption with the replacement of kanamycin by amikacin in the SCR, although such a change is not supported by evidence.
我们了解到,某些PICO问题无法直接回答,建议必须基于间接证据的推断。但是,这需要向计划和临床医生明确,以便他们有权做出适当的,明智的临床决策。随着DR-TB的复杂领域的证据以及新的观察和临床试验数据的可用性,指南可以明确区分证据,专家意见和假设,从而允许对围绕围绕不确定性的不确定性,这是至关重要的。建议。
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脚注
作者的贡献:l . Guglielmetti和f . Varaine made a substantial contribution to the conception of the work, wrote the manuscript, critically revised the manuscript for important intellectual content, and gave final approval of the current version to be published. H. Huerga and U. Khan critically revised the manuscript for important intellectual content and gave final approval of the current version to be published.
Conflict of interest: L. Guglielmetti is co-principal investigator of endTB and endTB-Q clinical trials.
利益冲突:H。Huerga没有什么可披露的。
利益冲突:U. Khan没有什么可披露的。
利益冲突:F。Varaine是MSF的ENDTB项目的总监。
- 已收到2019年10月1日。
- AcceptedDecember 19, 2019.
- 复制right ©ERS 2020