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介入放射学随机对照试验的可重复性和分类系统的外部验证。

The reproducibility of interventional radiology randomized controlled trials and external validation of a classification system.

机构信息

Department of Radiology and Interventional Radiology, Ochsner-Louisiana State University, Shreveport, United States.

出版信息

Diagn Interv Radiol. 2023 May 31;29(3):529-534. doi: 10.4274/dir.2023.222052. Epub 2023 Apr 18.

DOI:10.4274/dir.2023.222052
PMID:37070845
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10679611/
Abstract

PURPOSE

The fragility index (FI) measures the robustness of randomized controlled trials (RCTs). It complements the P value by taking into account the number of outcome events. In this study, the authors measured the FI for major interventional radiology RCTs.

METHODS

Interventional radiology RCTs published between January 2010 and December 2022 relating to trans-jugular intrahepatic portosystemic shunt, trans-arterial chemoembolization, needle biopsy, angiography, angioplasty, thrombolysis, and nephrostomy tube insertion were analyzed to measure the FI and robustness of the studies.

RESULTS

A total of 34 RCTs were included. The median FI of those studies was 4.5 (range 1-68). Seven trials (20.6%) had a number of patients lost to follow-up that was higher than their FI, and 15 (44.1%) had a FI of 1-3.

CONCLUSION

The median FI, and hence the reproducibility of interventional radiology RCTs, is low compared to other medical fields, with some having a FI of 1, which should be interrupted cautiously.

摘要

目的

脆弱指数(FI)衡量随机对照试验(RCT)的稳健性。它通过考虑结局事件的数量来补充 P 值。在这项研究中,作者测量了主要介入放射学 RCT 的 FI。

方法

分析了 2010 年 1 月至 2022 年 12 月发表的与经颈静脉肝内门体分流术、经动脉化疗栓塞术、经皮肝穿刺活检术、血管造影术、血管成形术、溶栓和肾造口术相关的介入放射学 RCT,以测量研究的 FI 和稳健性。

结果

共纳入 34 项 RCT。这些研究的中位数 FI 为 4.5(范围 1-68)。有 7 项试验(20.6%)的失访患者数量高于其 FI,15 项试验(44.1%)的 FI 为 1-3。

结论

与其他医学领域相比,介入放射学 RCT 的中位数 FI 较低,因此其可重复性较低,有些 FI 为 1,应谨慎中断。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4f2/10679611/f80b56cafdab/DIR-29-529-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4f2/10679611/f80b56cafdab/DIR-29-529-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4f2/10679611/f80b56cafdab/DIR-29-529-g1.jpg

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