Framework for planning and conducting pilot studies

Researchers working with partners in home care to plan a pragmatic multicenter community-based, randomized, controlled trial for leg ulcer compression treatment realized a smaller pilot study would be necessary. Because no framework for conducting pilot studies could be found, the authors developed a framework for pilot study methodology to inform the planning of such research. To this end, an integrative literature review was conducted, guided by an explicit search strategy, retrieval procedures, and appraisal process, to identify recognized pilot study aims, processes, and methodologies used in previously reported community pilot studies. Factors influencing study inclusion were recognized pilot study aims and purposes and a concise working definition of pilot study. Methodologies used in previously conducted community pilot studies were reviewed. Although relevant published research was limited, 11 pilot studies met the inclusion criteria for this review and contained suggestions to further develop or improve plans for larger definitive trials to enable a better fit of protocols within the delivery systems and scopes of practice. Pilot research processes could be divided into two stages: early planning and pilot trial. Direction for procedures and methods was gained relative to planning for an effective pilot study regarding eligibility, recruitment and data collection, management, and analysis. The results were used to develop an organizing framework for the authors' pilot study and named the Pilot Research Process (PReP) Framework. The process was instrumental in working with the authors' research team and clinical partners in the planning of their leg ulcer treatment pilot study. This framework may provide a foundation for others to analyze or develop a pilot study methodology in planning a large-scale study.