Framework for Planning and Conducting Pilot Studies

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Author(s): 
Lisa Janette Smith, RN, MSc; and Margaret B. Harrison, RN, PhD

Abstract: 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.



Please address correspondence to: Lisa Janette Smith, RN, MSc, Nurse Navigator, COPC, Office B3-009, Hotel Dieu Hospital, 166 Brock Street, Kingston, Ontario K7L 5G2 Canada; email: smithl2@hdh.kari.net.

     Research has not provided specific recommendations on the use of compression bandages for venous ulcers in home care largely due to small, underpowered trials conducted to date.1,2 The lack of clear information on the effectiveness of bandaging technologies and substantial resource differences in terms of supply costs and nursing time are concerning for home care authorities. In planning a pragmatic, multicenter community-based randomized controlled trial (RCT), it became clear there would be numerous methodological and logistical challenges. The purpose of the study, the Canadian Bandaging Trial (CBT) is to determine the effectiveness and efficiency of two different compression technology systems (four-layer versus short-stretch) on venous leg ulcer healing. The purpose of this project was to develop a framework for pilot study methodology to inform the planning of a randomized, controlled, multicenter, community-based leg ulcer bandaging study.

Background

     RCT experience is limited in community settings generally and even more so in the area of chronic wound care. Large-scale compression bandaging trials have been conducted internationally, but there is no published experience conducting such studies in Canada. Bandaging trials included in the Cochrane database were carried out in hospital clinic settings or community leg ulcer services in the UK.3-7 These trials were instrumental in providing data to calculate a sample size estimate based on time to healing (414 participants would be needed to achieve 80% power at 0.05 level of significance).

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