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

Abstract

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. 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. 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. 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.