Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

By S. Eldridge, Gillian Lancaster, Michael Campbell, Lehana Thabane, Sally Hopewell, Claire L. Coleman, C. Bond. PLoS ONE, 2016

1,273 citations recorded by the source corpus.

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

Subfields: Economics and Econometrics, Sociology and Political Science, Statistics and Probability

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Citations in the corpus

Improving Methodological Standards in Behavioral Interventions for Cognitive Enhancement (2019, background): “…be value in re-conceptualizing many “pilot studies” as feasibility studies where dissemination of results is explicitly planned (although note that other groups have drawn different distinctions between feasibility and pilot studies, see for instance, Eldridge et al. 2016; Whitehead et al. 2014).”
Pilot Testing for Feasibility in a Study of Student Retention and Attrition in Online Undergraduate Programs. (2018, background): “Publishing is important for a number of reasons, not the least of which is that learning from the results of other pilot projects could potentially conserve time, energy, and research resources (Hinds & Gattuso, 1991; Doody & Doody, 2015; Eldridge et al., 2016).”