Table 6 Key findings relating to trust

Who should be involved in recruiting patients

The majority of staff felt that recruitment should be a joint venture involving a senior clinician and the research team to instil confidence and trust in the trial and ensure patient expectations are met.

Senior clinicians can build cases to support both treatments, provide reassurance about them being routinely provided and communicate the grey areas and complexities surrounding treatment. Consultants were considered best placed to challenge patients with strong preferences, particularly when based on information received from clinicians in other specialties.

Research staff are crucial for overcoming equipoise issues and communicating study details as this is part of their daily role.

Patients were aware when recruiters did not appear knowledgeable about interventions.

Avoiding key terminology was perceived to cause uncertainty and undermine confidence and trust.

“The pros are that the clinician has a very in-depth understanding and is used to presenting information about those two treatment options. In think the negative, sometimes can be in relation to knowledge of how a research trial works and the potential pitfalls of presenting information in a certain way that might lead the patient one way or the other, and how careful we need to be with that. Also, to make the patient feel very much not under pressure to join the trial. I think that’s something that, perhaps the research team is a bit better at, having more experience in that area, So I think there are pros and cons, and that obviously is clinician dependent and research team member dependent. Certainly what we found worked really well here, was to have the clinician present the clinical parts of it so that the patient knows that the clinical information is coming from a clinician who would be treating them. Then for the research team to explain participation, withdrawal procedures and all that kind of stuff.” (PRESTO staff interview)

Practicalities of ‘joint’ consultations

Time constraints, concerns about surgeon equipoise and availability meant the practicalities of involving surgeons and research staff at the same time at all consultations is challenging. To overcome this, at some sites, surgeons and research staff held separate conversations with patients about treatments and the study respectively.

“So I speak to them first. I tell them what it entails if they’re interested to be involved in the trial. If they are interested then I will let the research nurse know, who will also go through all the details of the trial.” (PRESTO staff interview)

Engagement of clinical teams

The central role of clinical teams in recruitment and checking whether patients are eligible means ensuring their continuous engagement is crucial in surgical trials.

PRESTO staff were concerned that PIs would lose enthusiasm over time and that reduced engagement could negatively affect recruitment.

“It was to be a study that lasts a long time and there can be periods where there’s not much recruitment, the concern is then that people get a bit bored and disengaged with it, and I think that’s a little but what’s happened to be honest. And I think if there was a trial that was going on for four, five years, by this point, people had already started to lose interest.” (PRESTO staff interview)