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Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials
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Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials
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Journal Article
Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials
2024
Overview
The target difference refers to the treatment effect specified in the sample size calculation conducted when designing the study to detect a difference between treatments (i.e. a superiority contrast). The main benefit of setting the target difference to the MID, if one were to do so, is that it ensures that the study has the required statistical power across a range of possible differences that are viewed as “important” to one or more stakeholder groups, assuming of course, that all the other assumptions of the sample size calculation are appropriate. Power is the proportion of these studies which would detect the effect of interest (as specified in the sample size calculation e.g. 2-sided p-value ≤ 0.05) if it really exists. Furthermore, it is often not reasonable to assume with confidence relevant nuisance parameters which have a bearing on the estimation of the treatment effect (e.g. the correlation between multiple baseline factors and the outcome of interest) [6]. [...]the stated power is often in practice an educated approximation (aside from considerations of the specification of the target difference).
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
