Dataset Information

Frequent fragility of randomized controlled trials for HCC treatment.

ABSTRACT:

Background

The fragility index (FI) of trial results can provide a measure of confidence in the positive effects reported in randomized controlled trials (RCTs). The aim of this study was to calculate the FI of RCTs supporting HCC treatments.

Methods

A methodological systematic review of RCTs in HCC treatments was conducted. Two-arm studies with randomized and positive results for a time-to-event outcome were eligible for the FI calculation.

Results

A total of 6 trails were included in this analysis. The median FI was 0.5 (IQR 0-10). FI was ≤7 in 4 (66.7%) of 6 trials; in those trials the fragility quotient was ≤1%.

Conclusion

Many phase 3 RCTs supporting HCC treatments have a low FI, which challenges the confidence in concluding the superiority of these drugs over control treatments.

SUBMITTER: Zhang H

PROVIDER: S-EPMC8034173 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Publications

Frequent fragility of randomized controlled trials for HCC treatment.

Zhang Hao H Li Jingtao J Zeng Wenting W

BMC cancer 20210409 1

<h4>Background</h4>The fragility index (FI) of trial results can provide a measure of confidence in the positive effects reported in randomized controlled trials (RCTs). The aim of this study was to calculate the FI of RCTs supporting HCC treatments.<h4>Methods</h4>A methodological systematic review of RCTs in HCC treatments was conducted. Two-arm studies with randomized and positive results for a time-to-event outcome were eligible for the FI calculation.<h4>Results</h4>A total of 6 trails were ...[more]

PMID: 33836710

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Project description:BackgroundEfficacy of an intervention is commonly evaluated using P values, in addition to effect size measures such as absolute risk reduction, relative risk reduction, and numbers needed to treat. However, these measures are not always intuitive to clinicians. The fragility index (FI) is a more intuitive number that can facilitate interpretation but can only be used with binary outcomes. FI is the minimum number of patients who must be moved from the nonevent group to the event group to turn a significant result nonsignificant. In this retrospective analysis, we assessed the robustness of cardiovascular randomized controlled trials (RCTs), which report a positive (statistically significant) primary outcome by using the FI.Methods and resultsWe searched Medline from 2007 to 2017 to identify cardiovascular RCTs published in 6 high impact journals (The Lancet, New England Journal of Medicine, Journal of the American Medical Association, Circulation, Journal of the American College of Cardiology and European Heart Journal). Only RCTs with sample sizes >500 and a 2-by-2 factorial design or dichotomous primary outcomes were selected. FI was calculated using a defined approach. Among the cohort of 123 RCTs that met inclusion criteria, median FI was 13 (interquartile range, 5-26). In 28 trials (22.8%), FI ranged between 1 and 4. In 37 trials (30.1%), number of patients lost to follow-up was higher than the FI. Pharmaceutical interventions had higher FI compared with other interventions, FI=19 (7-52; P=0.002). Median FI varied according to subspecialty (electrophysiology=2; heart failure=11; interventional cardiology=8; P=0.020) and multiregional RCTs had higher FI=22 (12-53.25; P=0.023). FI did not differ based on risk of bias indicators, funding, or publication year.ConclusionsConsiderable variations in FI were observed among cardiovascular trials, suggesting the need for careful interpretation of results, particularly when number of patients lost to follow-up exceeds FI.

Dataset Information

Frequent fragility of randomized controlled trials for HCC treatment.

Background

Methods

Results

Conclusion

Publications

Frequent fragility of randomized controlled trials for HCC treatment.

Similar Datasets

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