Abstract

IntroductionThere is limited guidance on methods for pilot and feasibility studies and, as a result, they are often poorly conducted or poorly reported.All CAM/IM modalities can be considered to be complex interventions; as such, the research on this topic faces additional challenges when compared to pharmaceutical studies. Pilot and feasibility studies should take account of intervention complexity, implementation, and acceptability; this focus suits the wider needs of CAM research and potentially contributes to improved study quality.This opinion paper provides a narrative summary of the literature relating to terminology & conceptual clarity, aims & objectives, epistemology, and research methods. Terminology & conceptual clarityDefinitions and conceptualisations of pilot and feasibility studies vary; attempts are made here to identify commonality. Recommended aims & objectives for pilot & feasibility studiesThe main purpose of pilot and feasibility studies is to assess the feasibility, acceptability, and potential effectiveness of new interventions or interventions in new contexts. Where a pilot trial is conducted, the feasibility of trial processes should also be evaluated. Epistemology, methods & research frameworksMixed methods is the most valuable data collection strategy for pilot and feasibility studies and their use can be successfully underpinned by a pragmatic epistemological stance. Several frameworks relevant to pilot and feasibility testing are explored. ConclusionRigorous feasibility testing is necessary to underpin high quality CAM/IM research. Employing mixed methods within an appropriate framework will generate vital data for optimising CAM/IM research and intervention delivery.

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