Abstract
Background
The purpose of this study was to apply both the fragility index (FI) and fragility
quotient (FQ) to evaluate the degree of statistical fragility in the distal fibular
fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the
DFF literature are statistically fragile.
Methods
We performed a PubMed search for distal fibular fractures clinical trials from 2000
to 2022 reporting dichotomous outcomes. The FI of each outcome was calculated through
the reversal of a single outcome event until significance was reversed. The FQ was
calculated by dividing each fragility index by study sample size. The interquartile
range (IQR) was also calculated for the FI and FQ.
Results
Of the 1158 articles screened, 23 met the search criteria, with six RCTs included
for analysis. Forty-five outcome events with 5 significant (p < 0.05) outcomes and 40 nonsignificant (p ≥ 0.05) outcomes were identified. The overall FI and FQ was 5 (IQR 4–6) and 0.089
(IQR 0.061–0.107), respectively.
Conclusions
The randomized controlled trials in the peer-reviewed distal fibular fracture literature
may not be as robust as previously thought, as incorporating statistical analyses
solely on a P value threshold is misleading. Standardized reporting of the P value, FI and FQ can help the clinician reliably draw conclusions based on the fragility
of outcome measures.
Keywords
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Article info
Publication history
Published online: March 17, 2023
Accepted:
March 16,
2023
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Ltd. All rights reserved.
