Outcomes of minimally invasive versus open hallux valgus surgical correction: A systematic review and fragility analysis
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AbstractBackground: Comparative trials evaluating surgical outcomes are critical in guiding treatment for hallux valgus. However, the statistical stability of these outcomes is not well documented. Purpose The purpose of this study was to evaluate the statistical fragility of comparative studies analyzing minimally invasive surgery (MIS) versus open techniques for hallux valgus correction.Study: Design A systematic review identified comparative studies assessing MIS versus open hallux valgus correction.Methods: Outcome data were extracted with Fragility Index (FI) and Continuous Fragility Index (CFI) calculated for significant outcomes, and reverse FI (rFI) and reverse CFI (rCFI) for nonsignificant outcomes. Fragility Quotient (FQ) was calculated for each and compared to the number of patients lost to follow-up (LTFU).Results: Of 628 studies screened, 18 met inclusion criteria, totaling 1,369 patients. Among 88 dichotomous outcomes, the median FI was 2, FQ was 0.021, rFI was 4, and rFQ was 0.072. For 236 continuous outcomes, the median CFI was 8, CFQ was 0.116, rCFI was 19, and rCFQ was 0.280.Conclusion: This is the first study to evaluate fragility in comparative trials on MIS versus open hallux valgus correction and among the first to assess reverse fragility in continuous outcomes. Significant results were more fragile than nonsignificant data and dichotomous outcomes were more fragile than continuous ones with nearly a quarter having an FI lower than the number of patients LTFU. Both outcome types demonstrated considerable statistical fragility supporting the cautious interpretation of MIS vs open hallux valgus findings and the reporting of statistical fragility data alongside P-values to better contextualize the robustness of clinical research.
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