Erschienen in:
06.08.2021 | Research and Reporting Methods
The Fragility Index for Assessing the Robustness of the Statistically Significant Results of Experimental Clinical Studies
verfasst von:
Adrienne K. Ho, MBBS
Erschienen in:
Journal of General Internal Medicine
|
Ausgabe 1/2022
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Excerpt
In a randomized controlled trial (RCT) comparing treatments A and B, a null hypothesis (H
0) of no difference in a primary outcome of interest is defined. Whether any observed difference is statistically significant has traditionally been based on the
P value and the confidence interval (CI). For a century, an arbitrary threshold of 0.05 (1/20) has been used to define statistical significance.
1 Because this probability is quite low, we conclude that
P ≤ 0.05 suggests that the observed difference between A and B is incompatible with H
0, and, with a ≥ 95% degree of certainty, that A and B are different. The 95% CI is a lower-upper limit in which the true effect estimate lies within a 95% certainty. A 95% CI that does not include the null effect size indicates the observed difference has reached statistical significance, and H
0 is rejected. The 95% CI provides information about the precision of the estimate and complements the
P value. Reporting both is recommended. …
