Randomized Controlled Trials on Thoracolumbar Burst Fracture Management Are Statistically Fragile: A Systematic Review.
systematic_review · Level I
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- Record sourced from PubMed, PMID 42640611.
- Also identified by DOI 10.1097/BSD.0000000000002140.
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Abstract
Statistical fragility analysis. The management of thoracolumbar burst fractures (TLBFs) is challenging, and many surgeons rely on randomized controlled trials (RCTs) to inform decision-making. RCTs often report P-values, which may not fully reflect statistical robustness. This study utilizes fragility statistics to assess the reliability of RCTs evaluating TLBF outcomes. Thoracolumbar burst fracture management remains controversial. Surgeons often rely on RCTs, though P-values alone may not reflect the reliability of the results. Fragility analysis offers deeper insight into the robustness of reported outcomes, yet its use in TLBF research remains limited. RCTs assessing TLBF management outcomes (2014-2024) were identified through PubMed, Embase, and Medline. Fragility index (FI) and reverse FI (rFI) were calculated as the number of events required to reverse the significance for significant and nonsignificant outcomes, respectively. Fragility quotient (FQ) was derived by dividing FI by the sample size. Subgroup analyses included pain, function, complications, perioperative metrics, and radiographic outcomes. Of the 1073 studies screened, 22 RCTs were included, yielding 179 outcomes (114 continuous and 65 dichotomous). The median FI was 6 [Interquartile Range (IQR) 3-15], indicating that a median of 6 patient reversals changes statistical significance. The median FQ was 0.13 (IQR=0.08-0.24). Subgroup analyses demonstrated median FQs of 6 for pain (IQR=3-12), 6 for function (IQR=3-9), 4 for postoperative complications (IQR=2.75-6), 7 for intraoperative complications (IQR=7-7), 16 for perioperative metrics (IQR=10-20), and 5 for radiographic outcomes (IQR=2-8). Outcomes reported in RCTs evaluating TLBF management are statistically fragile, with an overall fragility quotient of 0.13. The significance of radiographic outcomes can be altered by as few as 6 event reversals. Reporting fragility metrics alongside P-values is recommended to improve the interpretation of RCT results and enable better-informed surgical decisions.