Fragility Analysis Should Complement Statistical Reporting in Thrombosis Trials: Lessons from Reduced-Dose Direct Oral Anticoagulants for Cancer-Associated Venous Thromboembolism.

Authors

Ronald Chow, Sumeet Talwar, Manu Beniwal, Jameel Abdulrehman, Peter L Gross

Published in

Journal of thrombosis and haemostasis : JTH. Oct 03, 2026. Epub Oct 03, 2026.

Abstract

Randomized trials and meta-analyses in thrombosis are traditionally interpreted using effect estimates, confidence intervals, and p-values. While indispensable, these metrics often provide limited insight into the robustness of trials reporting statistically significant findings. Fragility analysis offers a complementary approach by quantifying the minimum number of event-status changes that would reverse statistical significance. Despite increasing adoption across oncology, ophthalmology, orthopedics, and cardiovascular medicine, fragility analysis remains underutilized in thrombosis studies. Using a recent meta-analysis comparing reduced- versus full-dose direct oral anticoagulants (DOACs) for extended treatment of cancer-associated venous thromboembolism as an illustrative example, we demonstrate how fragility analysis provides additional context regarding the stability of trial findings. More importantly, we argue that fragility analysis should become a routine adjunct to conventional statistical reporting in thrombosis trials and systematic reviews to facilitate interpretation of evidence, improve transparency, and enhance shared decision making.

PMID:
42829086
Bibliographic data and abstract were imported from PubMed on 04 Oct 2026.

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