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The statistical fragility of randomised controlled trials evaluating tranexamic acid against a saline control in
Christoph A Schroen1,2, Niklas H Koehne1, Auston R Locke1
1Department of Orthopaedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY,USA.
Introduction:
This study applied the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical fragility of outcomes reported in RCTs evaluating TXA against a saline control in total hip arthroplasty (THA).
Methods:
PubMed, Embase, and MEDLINE were searched for RCTs on TXA in THA compared to a saline control. FI and rFI were calculated for dichotomous outcomes, representing the number of outcome reversals required to alter significance.
Results:
32 studies were included. Across 69 total outcomes, the median FI was 3.0 (IQR 2.0-6.0) with an associated median FQ of 0.031 (IQR 0.020-0.053), suggesting that 3 outcome event reversals would alter significance for 50% of all outcomes. 18 outcomes were statistically significant, with a median FI of 3.0 (IQR 1.0-5.0) and a median FQ of 0.026 (IQR 0.017-0.036). 51 outcomes were non-significant, with a median rFI of 4.0 (IQR 2.5-7.0) and a median FQ of 0.032 (IQR 0.020-0.066). Results designated as primary outcomes were more fragile (median FQ = 0.025, n = 20) than non-primary outcomes (median FQ = 0.032, n = 49).
Conclusions:
The efficacy of TXA use during THA from RCTs is statistically fragile, particularly among significant outcomes and those related to blood or platelet transfusion rates. We recommend combined reporting of p-values with FI and FQ metrics to help interpret clinical findings in RCT involving TXA use during THA.