Sample size and RCT data - Analysis of RCT data

5 important questions on Sample size and RCT data - Analysis of RCT data

What is meant with ''one follow-up measurement''? And what do you measure?

Comparing change over time between two groups.
Absolute change.

What problem can occur regarding change scores? And explain

Regression to the mean.

When both groups differ in their mean values and the intervention does not have an effect, the group with the highest average value will go down, while the group with the lowest average value will go up.

Important factors of longitudinal analysis of covariance


➢ Don’t look at the p-value of the interaction term
➢ Report regression coefficient, p-value and the confidence interval
➢ Report the effects at both different time points
➢ Report the overall effect over time
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What is a solution for the regression of the mean?

Solution: Analysis of covariance.
➢ Adjusting the analysis for the baseline value
➢ The best/only good analysis of RCT data with one follow-up measurement

What two options do you have with ''more than one follow-up measurement''?

A. Analyse the follow-up measurements seperately. Problem: the data used in the two analyses are highly correlated. You have to take this into account.
B. Longitudinal analysis of covariance
i. Long data structure (more than one record for each individual)
ii. Performed with GEE analysis or mixed model analysis

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