Journal
EUROPEAN HEART JOURNAL
Volume 38, Issue 5, Pages 338-+Publisher
OXFORD UNIV PRESS
DOI: 10.1093/eurheartj/ehw427
Keywords
Heart failure; Clinical trials
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Aims Guidelines for the management of chronic heart failure (CHF) cite the results of randomized controlled trials (RCTs) to support treatment recommendations. The significance of an observed treatment-effect relies on the use of a boundary P-value, most commonly P<0.05. There is concern about relying on arbitrary threshold P-values to report results as `statistically significant'. The `fragility index' (FI) has been proposed as an additional measure of the robustness of trial findings. FI is the minimum number of events needing to change from a non-event to an event in order to render a significant result non-significant. We calculated the FI to examine the robustness of statistically significant RCTs in CHF. Methods and results Two reviewers extracted data from RCTs supporting treatment recommendations in CHF guidelines. Twenty-five eligible trials were identified with a median sample size of 2331 patients (range 129-8399) and a median number of primary endpoints of 688.5 (range 88-2031). For the primary endpoint (analysed for 20 trials), the median FI was 26 (range 0-118). The FI was <= 10 in 7 (35%) of these 20 trials, and in 4 (20%) trials the number of patients lost to follow-up in the treatment group exceeded the FI. Conclusion The results of some large RCTs in CHF hinge on a small number of events. The FI offers an additional, easy to understand metric, which augments the standard reporting of boundary P-values for statistical significance. The FI helps in the interpretation of the robustness of the results of RCTs.
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