Dataset Information

The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

ABSTRACT:

Background

The fragility index represents the minimum number of patients required to convert an outcome from statistically significant to insignificant. This report assesses the fragility index of head and neck cancer randomised, controlled trials.

Methods

Studies were extracted from PubMed/Medline, Scopus, Embase and Cochrane databases.

Results

Overall, 123 randomised, controlled trials were included. The sample size and fragility index medians (interquartile ranges) were 103 (56-213) and 2 (0-5), respectively. The fragility index exceeded the number of patients lost to follow up in 42.3 per cent (n = 52) of studies. A higher fragility index correlated with higher sample size (r = 0.514, p < 0.001), number of events (r = 0.449, p < 0.001) and statistical significance via p-value (r = -0.367, p < 0.001).

Conclusion

Head and neck cancer randomised, controlled trials demonstrated low fragility index values, in which statistically significant results could be nullified by altering the outcomes of just two patients, on average. Future head and neck oncology randomised, controlled trials should report the fragility index in order to provide insight into statistical robustness.

SUBMITTER: Suresh NV

PROVIDER: S-EPMC10950446 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

Suresh Neeraj V NV Go Beatrice C BC Fritz Christian G CG Harris Jacob J Ahluwalia Vinayak V Xu Katherine K Lu Joseph J Rajasekaran Karthik K

The Journal of laryngology and otology 20231005 4

<h4>Background</h4>The fragility index represents the minimum number of patients required to convert an outcome from statistically significant to insignificant. This report assesses the fragility index of head and neck cancer randomised, controlled trials.<h4>Methods</h4>Studies were extracted from PubMed/Medline, Scopus, Embase and Cochrane databases.<h4>Results</h4>Overall, 123 randomised, controlled trials were included. The sample size and fragility index medians (interquartile ranges) were ...[more]

PMID: 37795709

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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

The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

Background

Methods

Results

Conclusion

Publications

The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

Similar Datasets

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