AI Article Synopsis
- The study evaluated the statistical stability of outcomes from randomized controlled trials (RCTs) focusing on the management of femoral neck fractures, using metrics like fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ).
- After screening 985 articles, 71 studies were analyzed, revealing a median FI of 4, indicating that a small number of event reversals could change the statistical significance of findings.
- The results suggest that many outcomes in these RCTs are fragile, prompting the authors to recommend standardized reporting of P-values to improve the reliability of the data.
Article Abstract
Objectives: Randomized controlled trials (RCTs) in the femoral neck fracture literature frequently report P -values for outcomes, which have substantial implications in guiding surgical management. This study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the statistical stability of outcomes reported in RCTs evaluating the management and treatment of femoral neck fractures.
Design: PubMed, Embase, and MEDLINE were queried for RCTs (January 1, 2010 to February 28, 2023).
Setting: RCTs that evaluated surgical management or treatment of femoral neck fractures were included.
Study Selection Criteria: RCTs with 2 treatment arms reporting categorical dichotomous outcomes were included. Non-RCT studies, RCTs with greater than 2 treatment arms, and RCTs without a femoral neck fracture cohort were excluded.
Outcome Measures And Comparisons: The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant ( P < 0.05) and nonsignificant ( P ≥ 0.05) outcomes, respectively. The FQ was calculated by dividing the FI by the sample size for the study.
Results: Nine hundred eighty-five articles were screened, with 71 studies included for analysis. The median FI across a total of 197 outcomes was 4 [interquartile range (IQR) 2-5] with an associated FQ of 0.033 (IQR 0.017-0.060). Forty-seven outcomes were statistically significant with a median FI of 2 (IQR 1-4) and associated FQ of 0.02 (IQR 0.014-0.043). One hundred fifty outcomes were statistically nonsignificant with a median rFI of 4 (IQR 3-5) and associated FQ of 0.037 (IQR 0.019-0.065).
Conclusions: Statistical findings in femoral neck fracture RCTs are fragile, with reversal of a median 4 outcomes altering significance of study findings. The authors thus recommend standardized reporting of P -values with FI and FQ metrics to aid in interpreting the robustness of outcomes in femoral neck fracture RCTs.
Level Of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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| http://dx.doi.org/10.1097/BOT.0000000000002793 | DOI Listing |
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