| Title: |
Revisiting the FAITH Trial:A Secondary Analysis Yielding Novel Insights with the Win Ratio |
| Authors: |
Bzovsky, Sofia; O'Hara, Nathan N.; Slobogean, Gerard P.; Sprague, Sheila; Axelrod, Daniel E.; Hoit, Graeme; Pannozzo, Kiara; Bhandari, Mohit; Swiontkowski, Marc; Schemitsch, Emil H.; Nauth, Aaron; Poolman, Rudolf W. |
| Source: |
Bzovsky, S, O'Hara, N N, Slobogean, G P, Sprague, S, Axelrod, D E, Hoit, G, Pannozzo, K, Bhandari, M, Swiontkowski, M, Schemitsch, E H, Nauth, A, Poolman, R W & the FAITH Investigators 2025, 'Revisiting the FAITH Trial : A Secondary Analysis Yielding Novel Insights with the Win Ratio', JBJS Open Access, vol. 10, no. 4, pp. e25.00230. https://doi.org/10.2106/JBJS.OA.25.00230 |
| Publication Year: |
2025 |
| Description: |
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 screws in 65, 158 (47.5%) comparisons, inferior to cancellous screws in 63, 378 (46.2%) comparisons, and tied in 8, 578 (6.3%), leading to a win ratio of 1.03 (95% confidence interval [CI] 0.86-1.23), but this difference was not statistically significant (p = 0.76). The sensitivity analysis results were similar at 6 and 12 months. In the subgroup analysis, a sliding hip screw was superior to cancellous screws in current smokers, with a win ratio of 1.65 (95% CI 1.02-2.65) at 6 months (p = 0.007). Conclusion: – This analysis approach ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
2472-7245 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/41281368; info:eu-repo/semantics/altIdentifier/eissn/2472-7245 |
| DOI: |
10.2106/JBJS.OA.25.00230 |
| Availability: |
https://pure.eur.nl/en/publications/181b2c67-fc70-4a95-a17e-759254b48c6f; https://doi.org/10.2106/JBJS.OA.25.00230; https://pure.eur.nl/ws/files/231082246/Revisiting_the_FAITH_Trial.pdf; https://www.scopus.com/pages/publications/105029516078 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Accession Number: |
edsbas.53A07DC2 |
| Database: |
BASE |