Community-based intervention research: coping with the "noise" of real life in study design.

The ultimate goal of clinical intervention research is to find a way to improve the care and lives of people suffering from specific psychiatric symptoms, illnesses, and/or disabilities. This article provides to clinical researchers a set of issues to consider and steps to follow in making the transition to more public-health-oriented, community-based research. Traditional, academically based, randomized clinical trials test an intervention against a placebo or alternate treatment control condition, focusing on a single, specific main outcome. Community-based intervention trials also test a treatment intervention but in the context of the community environment. These trials, in order to provide meaningful information for community clinical practice, must take into account many factors that are controlled or are not considered in traditional clinical trials. Investigators need to be clear about the goal of community-based interventions; they need to determine the social and cultural norms, expectations, and conflicts of the community and of the setting, and they need to work collaboratively with experts in both qualitative and quantitative design.