LAUSR

Feasibility and pilot studies, including feasibility and pilot trials, are essential for the future of occupational therapy; they confirm the need for and inform definitive research. Feasibility and pilot studies are important in laying the foundations for future research to support the evidence base, or in highlighting ineffective practice that should be stopped. Yet, ironically, these kinds of studies can be difficult to publish because they are usually, by definition, small and cannot provide clear or significant results. With the value of such studies in mind, the British Journal of Occupational Therapy (BJOT) is launching an ongoing e-collection to spotlight these methodologies and gather relevant articles together. The Medical Research Council (MRC) framework (Craig et al., 2008) recognises the importance of evaluating specific components in evaluating complex interventions, such as occupational therapy. The terms ‘feasibility’ and ‘pilot’ have been used interchangeably in the past and this has led to some confusion. It also means that older trials and studies may be labelled inappropriately according to the definitions used today. For this reason some clarification is needed here. Feasibility studies test the practicality of undertaking a research idea: In simple terms, is the study possible? The data that are collected determine issues around participant recruitment (e.g. Are the inclusion and exclusion criteria appropriate? Are there sufficient numbers available for recruitment to the study?), the practicalities of delivering an intervention (e.g. Will clinicians deliver the intervention? Will participants tolerate it?) and testing possible outcome assessments (e.g. Will participants complete them? Can participants be retained in the study long enough to complete follow-ups? Are the measures chosen useful or appropriate?). A feasibility study is the methodology of choice to test specific aspects or components of a proposed study. If it is important to test randomisation procedures (such as how to ensure blinded group allocation) and to find out if participants will agree to be randomised to different groups, this may also be done in a feasibility trial. Moreover, feasibility trials enable researchers to generate data to inform sample size calculations for a future definitive randomised controlled trial (RCT). Occupational therapy predischarge home visits for patients with a stroke (HOVIS) provides an example of a feasibility trial of delivering occupational therapy home visits to patients after stroke (Drummond et al., 2013). Here, specific concerns about whether clinicians would be willing to allocate their patients to a control arm in practice were tested. It is essential that conclusions are drawn from feasibility methodologies regarding the potential for a definitive trial. Concluding that a further study or trial is not feasible is just as valuable as confirmation that it is. Pilot studies or pilot trials are essentially smallerscale versions of a larger, definitive study. Pilots enable a rehearsal of the larger study to test all aspects of the proposed research. Pilot trials are not adequately powered to enable statistical conclusions to be drawn, so any analysis reported should be treated with caution; there is an obvious danger of either overor underestimating an effect. As an example of a pilot trial, Sackley et al. (2006) conducted a pilot evaluation of an occupational therapy intervention of residents in a care home who had a strokerelated disability; this study was the basis for obtaining subsequent funding and establishing the need for a larger trial (Sackley et al., 2015) Essential to both feasibility and pilot studies is their role in preventing wastage of scarce resources, such as time or money. Funders increasingly, and understandably, require such preliminary research to provide evidence that a larger study or trial is warranted. Preparation, through feasibility or pilot studies, is key to avoiding badly designed or underpowered research being conducted.