Differential dropout and bias in randomised controlled trials: when it matters and when it may not

Abstract

Dropout in randomised controlled trials is common and threatens the validity of results, as completers may differ from people who drop out. Differing dropout rates between treatment arms is sometimes called differential dropout or attrition. Although differential dropout can bias results, it does not always do so. Similarly, equal dropout may or may not lead to biased results. Depending on the type of missingness and the analysis used, one can get a biased estimate of the treatment effect with equal dropout rates and an unbiased estimate with unequal dropout rates. We reinforce this point with data from a randomised controlled trial in patients with renal cancer and a simulation study.