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
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, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial.
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