Tranexamic acid dosage and route of administration in total knee arthroplasty: A statistical review of randomized controlled trials
Bibliographic record
Abstract
Introduction: During total knee arthroplasty (TKA), tranexamic acid (TXA) can be used to reduce intraoperative bleeding, decreasing transfusion rates and total surgery costs. However, TXA's most effective administration protocol remains up for debate. This study used fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) metrics to evaluate the statistical robustness of outcomes reported in RCTs evaluating dosage and administration of TXA in TKA. Methods: PubMed, Embase, and MEDLINE were systematically searched for recent RCTs (January 1, 2014, and June 30th, 2024) assessing TXA use in TKA. The FI and rFI were calculated for all dichotomous outcomes, representing the number of outcome event reversals required to alter statistical significance for significant and non-significant outcomes, respectively. The FQ was determined by dividing the FI or rFI by the study sample size. Results: After screening, 51 studies were included for analysis. Across 134 total outcomes, the median FI was 4 (IQR 4-5) with an associated median FQ of 0.040 (IQR 0.023-0.057), suggesting that just 4 outcome event reversals would alter significance for 50 % of outcomes. 13 outcomes were statistically significant with a median FI of 2 (IQR 1-5) and FQ of 0.014 (IQR 0.011-0.057). 121 outcomes were non-significant with a median FI of 5 (IQR 4-6) and FQ of 0.040 (IQR 0.025-0.057). Outcomes were grouped into four categories, including blood or platelet transfusions (34 outcomes), thromboembolic events (33 outcomes), wound complications such as infections (21 outcomes), and other adverse events (46 outcomes). Their median FQs were 0.040, 0.039, 0.041, and 0.043, respectively. The 51 outcomes from studies published prior to 2018 showed a median FQ of 0.034, while the 84 outcomes published in 2018 or later showed a median FQ of 0.050. Across 108 outcomes from studies only administering TXA, the median FQ was 0.038, whereas the 26 outcomes from studies administering TXA and another drug showed a median FQ of 0.050. Conclusion: RCT outcomes describing TXA usage in TKA are statistically fragile, particularly among significant outcomes, thromboembolic events, and blood/platelet transfusion rates. Given this degree of fragility, current literature may not definitively prove a superior route of TXA administration in TKA. Further study including appropriately powered RCTs is recommended to further examine this field, along with combined reporting of p-values with FI and FQ metrics to aid in interpreting future clinical findings.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.054 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.015 | 0.015 |
| Bibliometrics | 0.005 | 0.007 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".