Table 5 Themes and subthemes relating to MIKROBE study objectives: supporting quotes from patients

Theme: Information and communication

• Objective/outcome: Assessment of the process of explaining the study (explanation/recruitment/randomisation, equipoise) between patients and surgeons, to ensure it is suitable in the event of progressing to a definitive study

• Objective/outcome: Analysis of reasons for patient’s nonparticipation and withdrawal

• Objective/outcome: Analysis of the acceptability of randomisation to patients and surgeons, including recommendations for future trial design

• Objective/outcome: Assessment of the feasibility of performing one-stage revision surgery

Evaluation or value of information provided

The information I was given told me everything I needed to know (Screened patient 63, declined to participate)

Sources and timepoints of information

I appreciate your time and everybody explaining me the study and the procedures (Screened patient 6, declined to participate)

Informed decision-making weighing up risk and choices based on information

Yeah so, you know, if my leg needs amputating, wake me up first. Make sure we’ve explored every option. By the same token, going into this surgery you know I kind of want to know what the route map is (Screened patient 54, withdrew after consultation with surgeon)

Theme: Recruitment and randomisation

• Objective/outcome: Assessment of the process of explaining the study (explanation/recruitment/randomisation, equipoise) between patients and surgeons, to ensure it is suitable in the event of progressing to a definitive study

• Objective/outcome: Analysis of reasons for patient’s nonparticipation and withdrawal

• Objective/outcome: Analysis of the acceptability of randomisation to patients and surgeons, as well as their thoughts about trial design

• Objective/outcome: Assessment of the feasibility of performing one-stage revision surgery

Choice (wanting or not wanting choice) of surgical approach and whether or not to participate

So I think I’ve got the best of both options now. So the cunning plan I came up with is how about we aim for one stage surgery … but if I’m struggling with it during the operation… then you’ve obviously got the right to revert me back to a two stage operation which would give me relief from the anaesthetic in the short term… and he [the surgeon] was absolutely fine with that… (Screened patient 43, withdrew after consultation)

Computer ‘deciding’

I want quality of life and [the surgeon] knows me better than a computer … Decision is best left to the consultant. How does a computer decide what’s best for me? I am a bit old fashioned, a consultant will know me better than a computer will (Screened patient 63, declined to participate)

Complex patient needs

‘Mr Average doesn’t exist’

I think the issue is that there isn’t an average patient. You know? Mr Average doesn’t exist. You know, you’ve got to overlay the individual circumstances onto the study… (Screened patient43, withdrew after consultation)

Research is a good thing

I am all for studies, anything that can improve things (Screened patient 63, declined to participate)

’Fed up’ with being ill

Really fed up and I just want it fixed (Screened patient 63 declined to participate)

Disempowered

I was in a bit of pain… trying to do two things at once was hard (Screened patient 54, declined to participate)

Theme: Equipoise, dissonance and challenging dogma

• Objective/outcome: Assessment of the process of explaining the study (explanation/recruitment/randomisation, equipoise) between patients and surgeons, to ensure it is suitable in the event of progressing to a definitive study

The average patient

Not just simply “well they’re having the type of surgery that we want to find out about”….Perfect client… no complications, nothing to, you know, consider outside of the box, you know? Mr Normal. He’d make the ideal client.. Outside of that, without me being rude, I think it just seemed too simplistic for me (Screened patient 43, withdrew after consultation)

Inclusion criteria

I think you need to think about, what are the things we think we need to look at to be able to quantify this patient should be a good fit. Because at the moment you’ve got it too broad… you need to make it a bit more focused (Screened patient 43, withdrew after consultation)

Patients weighing up risks

Well, I think we know what the risks are, but I just want to think about them a little bit, on my own … I want the single operation. However, I’d like my operation to be as risk adverse as possible… and the longer I’m under an anaesthetic, the more risky it becomes (Screened patient 43, withdrew after consultation)

Equipoise

… It didn’t make much difference to me as the knee was in quite a bad way anyway, so I thought why not just go for it. I was more than willing to do it (Participant 01 A, recruited to study, one stage surgery)

Dissonance

I think it’s worthwhile and yeah, anything that improves the outcomes of patients in orthopaedic surgeries, I’m all behind. You know, with the provisos I’ve given (Screen patient 43 withdrew after consultation)

Theme: Trial design

• Objective/outcome: Assessment of the patient’s experience (within 6 weeks after discharge following their definitive implant surgery) of the process of surgery, recruitment and randomisation to ensure these processes are acceptable to them in the event of progressing to a definitive study (structured pro forma style questionnaire)

Patient burden

Well it’s been a bit of a to-do. I was in hospital for three weeks, I was in intensive care and then I had COVID. I’ve been back and forth to the hospital a lot since. I don’t regret having it done though, it’s just been a long job. When you have your knee replaced you think it will be straightforward and the infections, they happen to someone else. When it does happen to you, well that’s a very difficult thing to live with (Participant 01 A, recruited to study, one stage surgery)

Cost drivers and considerations

With the other form [the questionnaires] it had all the trips and that.. but you haven’t allowed for being taken on these trips – my wife would have to drive me. Her loss of earnings as well as the cost of the fuel and parking. That I would need to be chauffeured around. So I got [the research nurse] to add that (Participant 01 A, recruited to study, one stage surgery)