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Updated: Sep 21, 2025

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Published on: September 16, 2022
Assessing and visualizing fragility of clinical results with binary outcomes in R using the fragility package
Lifeng Lin1, Haitao Chu2,3
1Department of Statistics, Florida State University, Tallahassee, FL, United States of America.
Abstract:
With the growing concerns about research reproducibility and replicability, the assessment of scientific results' fragility (or robustness) has been of increasing interest. The fragility index was proposed to quantify the robustness of statistical significance of clinical studies with binary outcomes. It is defined as the minimal event status modifications that can alter statistical significance. It helps clinicians evaluate the reliability of the conclusions. Many factors may affect the fragility index, including the treatment groups in which event status is modified, the statistical methods used for testing for the association between treatments and outcomes, and the pre-specified significance level. In addition to assessing the fragility of individual studies, the fragility index was recently extended to both conventional pairwise meta-analyses and network meta-analyses of multiple treatment comparisons. It is not straightforward for clinicians to calculate these measures and visualize the results. We have developed an R package called "fragility" to offer user-friendly functions for such purposes. This article provides an overview of methods for assessing and visualizing the fragility of individual studies as well as pairwise and network meta-analyses, introduces the usage of the "fragility" package, and illustrates the implementations with several worked examples.
Insights
The fragility index measures the robustness of clinical study results. An R package, "fragility," simplifies calculating and visualizing this index for individual studies and meta-analyses, enhancing research reliability.
Area of Science:
- Biostatistics
- Clinical Research Methodology
- Health Informatics
Background:
- Growing concerns regarding research reproducibility and replicability.
- The fragility index quantifies the robustness of statistical significance in clinical studies with binary outcomes.
- Assessing result reliability is crucial for informed clinical decision-making.
Purpose of the Study:
- To introduce an R package named "fragility" for calculating and visualizing the fragility index.
- To provide user-friendly functions for assessing the robustness of individual studies and meta-analyses.
- To demonstrate the application of the "fragility" package with practical examples.
Main Methods:
- Overview of methods for assessing the fragility index in individual studies, pairwise meta-analyses, and network meta-analyses.
- Development and introduction of the "fragility" R package.
- Illustration of package usage through worked examples.
Main Results:
- The "fragility" R package offers accessible tools for calculating and visualizing the fragility index.
- The package supports the assessment of fragility for single studies, pairwise meta-analyses, and network meta-analyses.
- Demonstrated ease of use and practical applicability of the "fragility" package.
Conclusions:
- The "fragility" package simplifies the complex task of assessing and visualizing result robustness.
- Enhanced accessibility to fragility index calculations aids clinicians in evaluating study reliability.
- Facilitates better understanding and application of research reproducibility measures in clinical practice.
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