Feasibility design in prevention research: A case example

Background: Feasibility studies are an important step in the process leading to design and implementation of clinical trials. However, few standards exist to guide researchers in designing and evaluating feasibility studies. In addition, a review of published feasibility studies reveals a wide variety of methods and outcome measures. Questions remain regarding sample sizes, comparison groups, fidelity and intent to treat in feasibility research. Methods: In this presentation, we will report the processes we used to plan, implement and evaluate an NIH funded feasibility study. The methods we used will be presented and compared with other published community based feasibility studies. Rationale for our study design will be presented and compared with those found in the literature. Opportunities to strengthen our work and future feasibility studies will be emphasized. Results: Challenges encountered in our study involved assessing ‘trends in improvement' in the intervention group when compared to the control condition. Our data collection procedures for both groups were lengthy and families with high depression scores were referred for further evaluation in the intervention and comparison conditions. We are questioning the potential therapeutic nature of data collection activities. In our literature review, we found that most researchers did not use comparison conditions, and ‘trends in improved outcomes' were often not reported. Instead, focus was on satisfaction, attendance and retention of participants. Conclusions: Questions remain about adequate sample sizes, realistic expectations for improvement in prevention research and the necessity of comparison groups.