2019
DOI: 10.21203/rs.2.10215/v1
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Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: Lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

Abstract: Background Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multi-centred, two-arm cohort randomised controlled trial – the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the RE… Show more

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