支持 CHEST 静脉血栓栓塞症临床实践指南的临床试验结果有多脆弱？
How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE?
机构信息
Oklahoma State University Center for Health Sciences, Tulsa, OK.
Oklahoma State University Center for Health Sciences, Tulsa, OK.
出版信息
Chest. 2018 Sep;154(3):512-520. doi: 10.1016/j.chest.2018.01.031. Epub 2018 Feb 2.
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.
背景
静脉血栓栓塞症仍然是全球人群关注的健康问题。临床实践指南对于指导医生预防和治疗静脉血栓栓塞症是必要的。
方法
我们的研究评估了用于支持 2016 年 CHEST 指南更新和抗血栓治疗静脉血栓栓塞症专家小组报告中治疗建议的 21 项随机对照试验（RCT）的基础证据的稳健性。我们计算了 RCT 中合格结局的脆弱指数和脆弱性分数。
结果
所有研究的中位数脆弱指数为 5（四分位间距，1-9），中位数脆弱性分数为 0.012（四分位间距，0.002-0.032）。
结论
我们的结论与之前对 RCT 结果脆弱性的研究一致；我们发现，一些用于支持 AT10 建议的结局是脆弱的。我们建议采用脆弱指数和脆弱性分数作为临床试验结果稳健性的衡量指标。
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