Fragility index for extended prophylaxis following abdominopelvic surgery: A methodological survey - 13/12/24
, Ruxandra-Maria Bogdan b, Kelly Brennan b, Victoria Shi c, Shan Grewal c, Cagla Eskicioglu a, c, Ameer Farooq b, Sunil Patel bAbstract |
Background |
Fragility Index (FI) is increasingly used to assess robustness of statistically significant p-values reported in randomized controlled trials (RCTs). FI represents the lowest number of non-events changed to events that would make study findings non-significant. This methodological survey was designed to assess the fragility of the evidence for extended VTEp following major abdominopelvic surgery.
Methods |
MEDLINE, Embase, and CENTRAL were searched from inception to November 2023. RCTs with parallel, double-armed, superiority design comparing extended VTEp for patients undergoing major abdominopelvic surgery to controls with at least one statistically significant dichotomous outcome were included. Walsh et al.’s method of calculating FI was utilized.
Results |
After review of 611 citations, 6 RCTs were identified with 12 statistically significant outcomes between groups. The mean number of patients randomized per RCT was 419 (SD 176). The median FI was 1.5 (range: 1–4). The number of patients lost to follow-up was greater than the FI for 10/12 (83.3 %) outcomes.
Conclusions |
Statistically significant differences reported in RCTs evaluating extended VTEp following major abdominopelvic surgery are not robust.
Le texte complet de cet article est disponible en PDF.Highlights |
• | RCT evidence evaluating extended VTEp after abdominopelvic surgery is fragile. |
• | Significance of findings is often lost after just one-to-two additional events. |
• | In most trials, the number of patients lost to follow-up exceeds the fragility index. |
• | Fragility should be kept in mind when applying these findings to patient care. |
Keywords : Venous thromboembolism, Extended venous thromboembolism prophylaxis, Surgery, Methodological survey, Fragility index
Plan
Vol 239
Article 116020- janvier 2025 Retour au numéro
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