Randomized Controlled Trials

RCTs are experimental studies that attempt to isolate the cause-and-effect relationship of an intervention on select outcomes. RCTs recruit participants that meet specified inclusion and exclusion criteria, randomly allocate these participants to two or more intervention groups, and then follow them over time to monitor for outcomes of interest. High-quality RCTs enable inferences regarding the effects of a treatment. However, deficiencies in the trial may introduce bias, obscuring the effect of the intervention.

This chapter will provide guidance in assessing RCTs for risk of bias and its potential impact on the results, as well as the clinical relevance of the findings.