Editorial: The Power of the Pilot

摘要

There seems to be a sense of urgency in our field to produce more Randomized Controlled Trials (RCTs) as the gold standard for research. When talking about RCTs as the gold standard, generally we are talking about efficacy or effectiveness trials that are designed to examine questions about whether an intervention had a statistically significant effect on specified outcomes. To examine such hypotheses, efficacy and effectiveness trials must be adequately powered and often require a large study sample. Yet, submitting authors often misrepresent small, underpowered studies as efficacy or effectiveness trials; resulting in the improper use of inferential statistics, and a missed opportunity to examine important fundamental questions of feasibility and acceptability that are essential in laving the foundation for larger trials. But, what distinguishes a well-designed pilot study from an efficacy or effectiveness trial? Pilot studies, also referred to as feasibility, exploratory, or preliminary trials, have been defined as, "A small-scale test of the methods and procedures to be used on a larger scale..." (Porta, 2008). Essentially, the pilot study allows investigators to develop a procedurally sound methodology, garner important information about intervention content, and ultimately determine whether it is feasible to proceed to the main study. It is not concerned with determining intervention effects; instead, it answers important questions about recruitment, randomization, retention, and evaluation procedures, as well as the content, timing, and delivery of interventions and control conditions in a clinical setting.