Abstract
Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for ‘real life’ variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study.
Highlights
Pilot studies focus on the science, process, management and resources of planned studies [1]
Lancaster et al described the purpose of pilot trials as being limited to collection of data for sample size re-calculation such that pilots do not allow for the pre-testing of the feasibility of other factors relating to the trial
We suggest that a degree of feasibility testing should be allowable in the internal pilots of pragmatic trials, and that scientific integrity can be maintained as long as the degree of variation to procedure is within the limits of variation likely to be seen in the full pragmatic trial
Summary
Pilot studies focus on the science, process, management and resources of planned studies [1]. Their purpose is to increase the likelihood of success of interventions in subsequent larger studies by ensuring they are appropriate and effective in practice [2,3,4]. Pilot studies help to justify the investment of money and time in those subsequent studies [5]. They are often a requirement of funding bodies [6]. It would seem pragmatic to extend this attitude to internal pilots
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