The importance of piloting an RCT intervention

The pilot study provides a unique opportunity to identify and prepare for the challenges of evaluating an intervention. Ultimately, it will enhance the scientific rigour and value of the full-scale study. Although some journals publish reports of pilot studies, little attention has been given to the types of research questions and issues specific to these studies. This article focuses on the utility of a pilot randomized controlled trial (RCT) as a first step towards conducting an RCT. Three major objectives of a pilot RCT are discussed: assessing the feasibility and acceptability of the intervention, assessing the feasibility and acceptability of the design and procedures, and facilitating the determination of effect sizes for use in sample-size calculations.