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Revisiting the FAITH Trial: A Secondary Analysis Yielding Novel Insights with the Win Ratio

作者:Sofia Bzovsky, Nathan N. O’Hara, Gerard P. Slobogean, Sheila Sprague, Daniel Axelrod, Graeme Hoit, Kiara Pannozzo, Mohit Bhandari, M.F. Swiontkowski, Emil H. Schemitsch, Rudolf W. Poolman, the FAITH Investigators · 发表于:JBJS Open Access · 年份:2025 · DOI:10.2106/jbjs.oa.25.00230 · 研究领域:Meta-analysis and systematic reviews、Health Systems, Economic Evaluations, Quality of Life、Total Knee Arthroplasty Outcomes

Background: Many orthopaedic trials use any unplanned reoperation as the primary outcome, but this overlooks how patients experience those outcomes. Using a high-quality hip fracture trial, we demonstrate how the relative importance of multiple patient-important outcomes can be effectively incorporated into data analysis, providing a more comprehensive understanding of treatment impact. Methods: This secondary analysis of the Fixation using Alternative Implants for the Treatment of Hip Fracture (FAITH) trial included 1,079 patients aged 50 years or older with a low-energy femoral neck fracture who were randomly assigned to treatment with a sliding hip screw or cancellous screws. The original trial used unplanned revision surgery as the primary outcome. Our primary analysis instead used a composite outcome of all-cause mortality at 4 months, ambulation status at 10 weeks (measured by the EuroQol-5 Dimension [EQ-5D] mobility dimension), and days at home within 4 months. We assessed outcomes hierarchically using the win ratio method, comparing each patient with every other patient in the alternative treatment group in a pairwise manner. We conducted sensitivity analyses at 6 and 12 months, and subgroup analyses to explore smoking status and fracture displacement as potential effect modifiers. Results: Of the 1,079 participants, 741 had EQ-5D data available for the primary analysis at 4 months, yielding 137,114 pairwise comparisons. A sliding hip screw was superior to cancellous ...