The fragility index (FI) was proposed as a simplified way to communicate robustness of statistically significant results and their susceptibility to a change of a handful number of events. While this index is intuitive, it is not anchored by a cut-off or a guide for interpretation. We identified cardiovascular trials published in six high impact journals from 2007 to 2021 (500 or more participants and a dichotomous statistically significant primary outcome). We estimated area under curve (AUC) to determine FI value that best predicts whether the treatment effect was precise, defined as adequately powered for a plausible relative risk reduction (RRR) of 25% or 30% or having a CI that is sufficiently narrow to exclude a risk reduction that is too small (close to the null, <0.05). The median FI of 201 included cardiovascular trials was 13 (range 1–172). FI exceeded the number of patients lost to follow-up in 46/201 (22.89%) trials. FI values of 19 and 22 predicted that trials would be precise (powered for RRR of 30% and 25%; respectively, combined with CI that excluded risk reduction <0.05). AUC for meeting these precision criteria was 0.90 (0.86–0.94). In conclusion, FI values that range 19–22 may meet various definitions of precision and can be used as a rule of thumb to suggest that a treatment effect is likely precise and less susceptible to random error. The number of patients lost to follow-up should be presented alongside FI to better illustrate fragility.
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Contributors MHM, ZW and AKB conceived the idea. AKB, MSK, AS and SS selected studies and extracted data. ZW conducted the analysis. MHM is the guarantor of this work.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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