Table 7 Scenario illustrating influence of acceptability on implementability

Study title

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

Background

Blepharospasm and hemifacial spasm are currently managed by regular Botox injections, given approximately every 2 months (appointments scheduled by the physician). But the timeline to return of symptoms following treatments is variable. It is possible that patient-initiated appointments (i.e. when symptoms flare up) could result in a more efficient and effective service. This possibility was tested in a randomised trial. A qualitative investigation of acceptability was conducted as a sub-study.

Aims

To apply the Theoretical Framework of Acceptability (TFA; consisting of 7 component constructs) to explore: (1) patient-reported reasons for declining to participate in the trial; and (2) associations between decliners’ perceptions of acceptability and their non-participation.

Method

Eligible patients (n = 242) were approached to participate in the trial. Phase 1: decliners provided a brief reason for refusal. We analysed the reasons descriptively and reviewed them against the TFA constructs. Phase 2: We invited consecutive decliners to participate in short semi-structured interviews, to explore their reasons for refusal in more depth. Interviews were transcribed and analysed, with the TFA as a coding framework.

Results

Eighty-seven (36%) eligible patients refused trial participation; all provided a reason. From interviews with 15 decliners, four key beliefs about acceptability were identified: happy with standard care, anticipated burden of the patient-initiated service, lack of confidence in ability to engage with new service and uncertainties about the effectiveness of new service. Two themes reflected non-TFA factors: trial participation was a low priority and the burden of completing trial documentation.

Conclusion

Reasons for refusing trial participation were often, but not always, associated with intervention acceptability.

Relationship to implementability

1. Three factors could be improved to enhance acceptability of the new service: reducing burden, enhancing patient support to increase confidence (making sure they are able to make contact by phone), and ensuring that the new service is perceived to be workable (increasing available appointment spaces).

2. Unless these factors can be satisfactorily addressed it appears that the new service would not be implementable.

Reference

Sekhon, M., Cartwright, M., Lawes-Wickwar, S., et al. (2021). Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study. Contemporary Clinical Trials Communications, 21, 100698.