Quantitative and Qualitative Strategies to Strengthen Internal Validity in Randomized Trials.

Although the randomized controlled trial (RCT) is the most reliable design to infer causality, evidence suggests that it is vulnerable to biases that weaken internal validity. In this paper, we review factors that introduce biases in RCTs and we propose quantitative and qualitative strategies for colleting relevant data to strengthen internal validity. The factors are related to participants' reactions to randomization, attrition, treatment perceptions, and implementation of the intervention. The way in which these factors operate is explained and pertinent empirical evidence is synthesized. Quantitative and qualitative strategies are described. Researchers can plan to assess these factors and examine their influence, providing evidence of what actually contributed to the interventions' causal impact.