The Role of Random Allocation in Randomized Controlled Trials: Distinguishing Selection Bias from Baseline Imbalance

Abstract

<p>Background: This paper addresses one threat to the internal validity of a randomized controlled trial (RCT), selection bias. Many authors argue that random allocation is used to ensure baseline equality between study conditions in a given study and that statistically significant differences at pretest mean that randomisation has failed.</p> <p>Purpose: The purpose of this study was to clarify the role of random allocation in an RCT study. Is the role of random allocation to protect against selection bias? And does it have a further role, namely to ensure baseline equality and the absence of statistically significant differences between study conditions at pretest?</p> <p>Setting: The participants for this study were 229 children in 1st and 2nd grade and data were collected as part of an RCT evaluation of a volunteer reading programme piloted in Ireland, Wizards of Words (WoW).</p>