AI Article Synopsis
- Randomized controlled trials (RCTs) on Achilles tendon pathology (ATP) often have small sample sizes, leading to fragile outcomes and inconsistent results, as shown by a median Fragility Index (FI) of 3 across the trials.
- The study involved 11 RCTs with a total of 4506 patients and evaluated 24 binary outcomes, with many findings indicating that changing just a few patient outcomes could lead to significant shifts from significant to nonsignificant results.
- Most studies demonstrated low to moderate risk of bias, and there was a lack of reporting on FIs and adjustments for multiple statistical tests, indicating potential areas for improvement in study design and reporting practices in ATP interventions.
Article Abstract
Background: Randomized controlled trials (RCTs) are the gold standard for treatment efficacy, but foot and ankle RCTs are often small or inconsistent. The Fragility Index (FI) evaluates the stability of significant findings. This study assessed the fragility of RCT outcomes for Achilles tendon pathology (ATP) interventions.
Methods: This systematic review queried PubMed up to May 14, 2024, for RCTs on ATP interventions. RCTs with significant binary outcomes were included. Two reviewers assessed eligibility, extracted data, calculated FIs, and evaluated risk of bias. Frequency-weighted means were used for narrative synthesis.
Results: Eleven RCTs with 4506 patients (mean cohort size: 409.64 ± 160.54) and a mean age of 36.97 ± 13.51 years (n = 4356; 96.67%) were included, covering 24 binary outcomes. The median FI across all outcomes was 3 (interquartile range 1-4; mean 3.92), indicating that changing the outcome of just a few patients could shift a study's results from statistically significant to nonsignificant. Trials having an FI ≤3 comprised 58.33%. Three outcomes (12.5%) had an FI of zero after recalculating values using the two-sided Fisher exact test. Half of the outcomes were robust. No RCT reported FIs or adjusted significance for multiple testing. Most studies (81.82%) performed 2 or more statistical tests, with an average of 30.81 ± 41.28 values reported per study. The overall risk of bias was low in 1 study (9.09%) and moderate in 7 (63.64%). Most studies had low risk of bias in randomization (72.73%) and missing outcome data (90.91%).
Conclusion: The FI assesses the fragility of statistically significant binary results, revealing that many ATP RCTs have fragile outcomes due to small sample sizes. A median FI of 3 means that changing the outcome of 3 patients could shift a study's results from statistically significant to nonsignificant.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11580056 | PMC |
| http://dx.doi.org/10.1177/24730114241300160 | DOI Listing |
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