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Therefore, we applied a correction for multiplicity of endpoints that adjusted the Type I error when a significant result was required for more than one but not all multiple primary outcomes after correction of multiplicity [ 33].
Moreover, the SPIRIT guidance suggests a minimum number of primary outcomes in clinical trials because multiple primary outcomes can introduce problems with multiplicity, selective reporting, and interpretation when there are inconsistent results across outcomes [ 22].
Although up to 38% of trials define multiple primary outcomes, 4 35 163 this practice can introduce problems with multiplicity, selective reporting, and interpretation when there are inconsistent results across outcomes.
To review how multiple primary outcomes are currently considered in the analysis of randomised controlled trials.
The combined problem of multiple primary outcomes, lack of specification of the instrument being used to measure the outcome, and non-reporting of time frames leaves the door open for fishing expeditions and will not solve the problem of selective reporting bias.
Since the primary outcome is the one that the study should be designed to evaluate, and hence used to calculate the sample size, it is also concerning that so many trials claim to have multiple primary outcomes with almost one in ten trials claiming four or more.
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In the sample size calculation, the significance level was adjusted for the multiple primary outcome measures.
We will use the Bonferroni method to appropriately adjust the overall level of significance for multiple (three) primary outcomes.
Assessment of ORB within a systematic review of a single primary outcome underestimates the risk of ORB in comparison to the assessment of multiple primary and secondary outcomes.
Multiple primary and secondary outcomes were chosen based on the specific aims of DAISY and on the outcomes from similar intervention studies for patients with more advanced dementia.
Therefore, multiple primary and secondary outcomes were exploratively chosen based on the specific aims of the DAISY and on the outcomes from similar intervention studies for patients with more advanced dementia. 1 Consequently, to avoid finding spurious effects, a significance level was set at p=0.0005, which was subsequently criticised for being too conservative.
More suggestions(15)
multiple adverse outcomes
multiple clinical outcomes
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multiple primary sites
multiple primary cancers
multiple primary malignancies
multiple primary networks
multiple primary protagonists
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multiple primary nodes
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multiple possible outcomes
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multiple primary campaigns
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