Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study

Abstract

Background: The generalizability of findings of Randomised Controlled Trials (RCTs) is undermined by low or biased recruitment. Reasons for participant refusal are infrequently reported in published literature. Aims: To apply the Theoretical Framework of Acceptability (TFA) to: (1) explore patient-reported reasons for declining to participate in a RCT comparing a new service model (patient-initiated appointments) with standard care (appointments scheduled by clinician) for managing blepharospasm and hemifacial spasm; (2) to explore associations between decliners’ perceptions of acceptability and non-participation. Method: Eligible patients (n = 242) were approached to participate in the tria..