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Designing an Effective, Small-Scope Practice-based Study

Parker, R. David PhD; Regier, Michael D. PhD

doi: 10.1097/MLR.0000000000000757
Statistical Workshop
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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.

School of Public Health, West Virginia University, Morgantown, WV

The authors declare no conflict of interest.

Reprints: R. David Parker, PhD, School of Public Health, West Virginia University, 1 Medical Center Drive, HSC Annex G103, Morgantown, WV 26506. E-mail: rdparker@hsc.wvu.edu.

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