Pilot Trials in Health-Related Behavioral Intervention Research: Problems, Solutions, and Recommendations

Pilot studies can help to pave the way for larger randomized controlled trials of health-related behavioral interventions. Unfortunately, there is widespread uncertainty and confusion about the kinds of studies that should or should not be called pilot trials, and about their relationship to other types of preliminary studies of behavioral interventions. The traditional conceptualization of pilot studies as "preliminary efficacy" trials has been especially problematic. This report identifies some common and problematic weaknesses in pilot trials. It also describes a strategy for preliminary research on behavioral interventions that can prevent these problems, and provides recommendations for researchers and reviewers.