Estimating risk from underpowered, but statistically significant, studies: Was APPROVe on TARGET?

La Caze, A. and Duffull, S. (2011) Estimating risk from underpowered, but statistically significant, studies: Was APPROVe on TARGET?. Journal of Clinical Pharmacy And Therapeutics, 36 6: 637-641. doi:10.1111/j.1365-2710.2010.01222.x


Author La Caze, A.
Duffull, S.
Title Estimating risk from underpowered, but statistically significant, studies: Was APPROVe on TARGET?
Journal name Journal of Clinical Pharmacy And Therapeutics   Check publisher's open access policy
ISSN 0269-4727
1365-2710
Publication date 2011-12-01
Year available 2010
Sub-type Article (original research)
DOI 10.1111/j.1365-2710.2010.01222.x
Volume 36
Issue 6
Start page 637
End page 641
Total pages 5
Place of publication Oxford, United Kingdom
Publisher Wiley-Blackwell Publishing
Collection year 2012
Language eng
Formatted abstract
What is known and objective:  The importance of statistical power is widely recognized from a pre-trial perspective, and when interpreting results that are not statistically significant. It is less well recognized that poor power can lead to inflated estimates of the effect size when statistically significant results are observed. We use trial simulations to quantify this bias, which we term ‘significant-result bias’.
Comment:  Significant-result bias is explained, and simulations are used to estimate possible significant-result bias in the rate of thrombotic events observed in the APPROVe trial. Statistically significant results, on outcomes for which there is empirical evidence of poor power, may provide inflated estimates of the size of effect.
What is new and conclusion:  If independent evidence is available to judge the likely effect size of an underpowered statistical test, trial simulations can provide a method for quantifying significant-result bias.
Keyword Bias
Clinical trials
Power
Rofecoxib
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Published under Commentary. Article first published online: 12 DEC 2010.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2012 Collection
School of Pharmacy Publications
 
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Created: Wed, 26 Oct 2011, 20:51:31 EST by Mr Adam La Caze on behalf of School of Pharmacy