Designing an Effective, Small-Scope Practice-based Study

OBJECTIVE: Present a methodology to promote good practices in designing small-scale, practice-based studies. STUDY DESIGN: We propose the following methods to assist clinicians and other practice-based researchers in designing and conducting good quality, small-scale studies in a clinical setting. METHODS: Research projects applied to a limited, practice-based study may require modification to increase the consistency of patient research. RESULTS: Although common requests to collaborative methodologists mirror methods for experimental design, clinic-based studies may face different limitations. Each participant enrolled consumes resources, including time, and personnel. If practice-based studies have a different goal, to learn about the health outcomes of patients in a medical practice with limited intent for generalization, should the same methods be used? CONCLUSIONS: When limitations are clearly stated and the findings are described within the study context, these limitations may not be so severe to discourage the research. We propose a systematic method to conduct practice-based research intended for small-scale study use. Relying heavily on existing research from similar areas, the incorporation of data from the practice, and the a priori defined timelines and resources, we set forth some guiding principles to assist clinic-based investigators. Individualized focus and small-scale studies are growing in use and acceptance especially given the focus on personalized health.