Baseline imbalance in randomised controlled trials

In a controlled trial randomisation ensures that allocation of patients to treatments is left purely to chance. The characteristics of patients that may influence outcome are distributed between treatment groups so that any difference in outcome can be assumed to be due to the intervention. However, imbalance between groups in baseline variables that may influence outcome (such as age or disease severity) can bias statistical tests, a property sometimes referred to as chance bias Observed differences in outcome between groups in a particular trial could by chance be due to characteristics of the patients, not treatments. Some protection against chance bias is given by stratified randomisation or minimisation and by adjusting in the statistical analysis for baseline variables.

In reporting clinical trials it is recommended that prognostic variables should be described for each treatment group.1 This may …