How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE?
How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE?
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DOI：
10.1016/j.chest.2018.01.031
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发表时间：
2018-09-01
期刊：
影响因子：
9.6
通讯作者：
Vassar, Matt
中科院分区：
文献类型：
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作者：
Edwards, Elizabeth;Wayant, Cole;Vassar, Matt
背景：静脉血栓栓塞仍然是全球人口关注的健康问题。临床实践指南对于指导医生预防和治疗静脉血栓栓塞是必要的。方法：我们的研究评估了21项随机对照试验（rct）的基础证据的稳健性，这些试验用于支持2016年更新的CHEST指南和VTE疾病抗血栓治疗专家小组报告中的治疗建议。我们计算了随机对照试验中合格结果的脆弱性指数和脆弱性商数。结果：所有研究的脆弱性指数中位数为5（四分位数范围为1-9），脆弱性商中位数为0.012（四分位数范围为0.002-0.032）。结论：我们的结论与之前关于RCT结果脆弱性的研究结果相似；我们发现，用于支持AT10建议的一些结果是脆弱的。我们建议采用脆弱性指数和脆弱性商数作为临床试验结果稳健性的衡量标准。
BACKGROUND: VTE remains a health concern for global populations. Clinical practice guidelines are necessary to guide physicians in the prophylaxis and treatment of VTE.METHODS: Our investigation assessed the robustness of the underlying evidence in 21 randomized controlled trials (RCTs) used to support treatment recommendations in the 2016 update of the CHEST Guideline and Expert Panel Report on Antithrombotic Therapy for VTE Disease. We calculated the fragility index and fragility quotient for qualifying outcomes within RCTs.RESULTS: The median fragility index for all studies was 5 (interquartile range, 1-9), with a median fragility quotient of 0.012 (interquartile range, 0.002-0.032).CONCLUSIONS: Our conclusions parallel those of previous investigations of the fragility of RCT outcomes; we found that some outcomes used to support recommendations in AT10 are fragile. We recommend that the fragility index and fragility quotient be adopted as measures of robustness of clinical trial outcomes.