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The fragility index applied to liver-related trials

Indian Journal of Gastroenterology volume 38, pages 456–459 (2019)Cite this article

Abstract

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.

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Affiliations

  1. Center for Health Sciences, Oklahoma State University, 1111 W. 17th St, Tulsa, OK, 74107, USA

    Chase Meyer

  2. Hospitalist, Citizens Memorial Hospital, 1500 N. Oakland Ave, Bolivar, MO, 65613, USA

    Trace E. Heavener

  3. Center for Health Sciences, Oklahoma State University, 1111 W. 17th St, Tulsa, OK, 74107, USA

    Matt Vassar

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  1. Chase Meyer
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  2. Trace E. Heavener
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  3. Matt Vassar
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Correspondence to Trace E. Heavener.

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All authors have made substantial contributions to drafting the study protocol and writing the manuscript. The first and second authors were responsible for data collection and summarization.

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CM, TEH, and MV declare that they have no conflict of interest.

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The study was performed conforming to the Helsinki declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

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Meyer, C., Heavener, T.E. & Vassar, M. The fragility index applied to liver-related trials. Indian J Gastroenterol 38, 456–459 (2019). https://doi.org/10.1007/s12664-019-00996-x

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  • DOI: https://doi.org/10.1007/s12664-019-00996-x

Keywords

  • Fragility index
  • Hepatology
  • Methodology
  • P-value
  • Randomized controlled trial