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

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

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.

Keywords: Fragility index; RCT; interventional; radiology; reproducibility.

MeSH terms

  • Humans
  • Radiology, Interventional*
  • Randomized Controlled Trials as Topic
  • Reproducibility of Results