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Lookup NU author(s): Dr Theophile Bigirumurame
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
ObjectiveThe use of minimum clinically important difference in the hypothesis formulation for superiority trials is similar in principle to the concept of non-inferiority or equivalence trial. However, most clinical trials are analysed testing zero clinical difference. Since the minimum clinically important difference is pre-defined for power calculation, it is important to incorporate it in both the hypothesis testing and the interpretation of findings from clinical trials. Results We reviewed a set of 50 publications (25 with binary outcome, and 25 with survival time outcome). 20% of the 50 published trials that were statistically significant, were also clinically significant based on the minimum clinically important risk differences (or hazard ratio) used for their power calculations. This snap review seems to suggest that most published trials with statistically significant results were less likely to be clinically significant, which may partly explain the high false positive findings associated with findings from superiority trials. Furthermore, none of the reviewed publications explicitly used minimum clinically important difference in the interpretation of their findings. However, a systematic review is needed to critically appraise the impact of the current practice on false positive rate in published trials with significant findings.
Author(s): Bigirumurame T, Kasim A
Publication type: Article
Publication status: Published
Journal: BMC Research Notes
Year: 2017
Volume: 10
Online publication date: 28/12/2017
Acceptance date: 21/12/2017
Date deposited: 03/01/2018
ISSN (electronic): 1756-0500
Publisher: BioMed Central Ltd.
URL: https://doi.org/10.1186/s13104-017-3117-4
DOI: 10.1186/s13104-017-3117-4
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