The fragility index applied to liver-related trials

The goal of this manuscript was to apply the fragility index (FI), which is a statistically sound method to evaluate robustness of test results, to liver-related randomized clinical trials. The authors searched the ClinicalTrials.gov database with the following limitations: term “liver,” recruitment...

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Bibliographic Details
Published in:Indian journal of gastroenterology 2019-10, Vol.38 (5), p.456-459
Main Authors: Meyer, Chase, Heavener, Trace E., Vassar, Matt
Format: Article
Language:English
Subjects:
Clinical Trials as Topic - statistics & numerical data
Data Interpretation, Statistical
Gastroenterology
Gastroenterology - methods
Hepatology
Humans
Liver Diseases
Medicine
Medicine & Public Health
Short Report
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Summary:The goal of this manuscript was to apply the fragility index (FI), which is a statistically sound method to evaluate robustness of test results, to liver-related randomized clinical trials. The authors searched the ClinicalTrials.gov database with the following limitations: term “liver,” recruitment completed, with results, interventional study type, last updated May 01, 2016, to May 01, 2017. Forty-eight trials were included and four had FI of 0. The median FI for trials moving from significance to non-significance was 6 (IQR 18; 2 to 20), while the median for trials moving from non-significance to significance was 5 (IQR 5; 4 to 9). The median number lost to follow up was 17 (IQR 42; 3 to 45). Of the 21 trials that showed statistical significance, the number lost to follow up was greater than the FI in 13 (61.90%) trials. Investigators of liver-related studies should consider adding the FI to evaluate their work.
ISSN:0254-8860
0975-0711
DOI:10.1007/s12664-019-00996-x