Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial.
- complex intervention
- pilot trial
- feasibility study
- pelvic organ
Bugge, C., Williams, B., Hagen, S., Logan, J., Glazener, C., Pringle, S., & Sinclair, L. (2013). A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials, 14, . https://doi.org/10.1186/1745-6215-14-353