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Fragility Index in Randomized Controlled Trials of Ischemic Stroke
Kenichiro Sato1, Tatsushi Toda1, Atsushi Iwata1
1Department of Neurology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Summary
The fragility index (FI) indicates that randomized controlled trials (RCTs) in ischemic stroke research are generally robust. Most studies required at least 7 events to change their significant results, showing good reliability.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- The fragility index (FI) is a novel metric assessing the robustness of randomized controlled trials (RCTs).
- Evaluating the FI in neurological studies, specifically ischemic stroke, is crucial for understanding research reliability.
Purpose of the Study:
- To evaluate the fragility index (FI) of randomized controlled trials (RCTs) in ischemic stroke research.
- To compare the robustness of these RCTs with studies in other clinical fields.
Main Methods:
- A literature review of RCTs in ischemic stroke published between June 2012 and May 2018 was conducted.
- The fragility index (FI) was calculated for studies with a dichotomous primary outcome measure.
- Existing literature on FI in other clinical fields was reviewed and summarized.
Main Results:
- Twenty-five RCTs were included, with a median participant count of 206.
- The median fragility index (FI) was 7, indicating a strong negative correlation with P values.
- The median FI in ischemic stroke RCTs was higher than in other fields, with only 20% having an FI below 2.5.
Conclusions:
- Randomized controlled trials (RCTs) in ischemic stroke demonstrate fair robustness.
- The findings suggest that results from ischemic stroke RCTs are generally reliable when compared to other clinical areas.
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