Professionals’ acceptance of randomisation was observed to be largely influenced by two factors: (1) their understanding of the limitations of existing data and hence the need for RCTs to generate high-quality evidence in BR and (2) their understanding and acceptance of pragmatic trial design.
Limited understanding of problems with existing evidence and need for RCTs in breast reconstruction
A number of professionals did not appear to understand why randomised trials in BR are necessary. This lack of understanding seemed to be due to a limited appreciation of the importance of randomisation in minimising bias. Several professionals said they would refuse randomisation as a method of treatment allocation to determine treatment effectiveness because they perceived that equivalent data could be produced by utilising a number of nonrandomised study designs that included clinical audits.
“I’m telling you how the information that you’re trying to capture from the randomised trial can be captured just by having a good audit.” (Mr J, OPBS, centre 6)
“It is very important that we do produce good long-term outcome data.... [D]o you actually need a randomised controlled trial to produce that data?” (Mr G, plastic surgeon, centre 4)
“We’re always talking about randomised controlled trials…. I would’ve thought, to be honest with you, a far better way is about PROMS [patient-reported outcome measures]…. [I]t’s about the patient-reported outcome measures…. I mean, I think it’s far, far more valuable than a randomised controlled trial.” (Mr T, plastic surgeon, centre 12)
“I just wonder if we need to think a little more laterally about how we assess breast reconstruction…. I know that randomisation is seen as the gold standard, but that’s the gold standard for drugs, not necessarily for surgery, and I just wonder whether there are other ways and other mechanisms that we should be exploring.” (Miss N, OPBS, centre 7)
Most participants who said they felt trials are important were happy to consider randomisation in situations where they believed equipoise to exist:
“There are loads of questions that are not answered. Different manufacturers … one-stage implants as against two-stage, so Becker-35 or a McGhan-150 [different types of implants] against the tissue expander followed by a permanent implant. I would be quite comfortable doing those types of trials because I think they’re equivalent and I really, genuinely don’t know the answer.” (Mr H, OPBS, centre 5)
Randomisation was rejected when equipoise was perceived to be absent. For the majority of professionals, however, perceptions of equipoise were largely based on observational data, personal experience or surgical dogma.
“I’ve got a fairly clear idea of who I think will benefit from [a type of BR].... I would find it difficult to randomise the patients, because my experience has already shown me that they get a better cosmetic outcome.” (Miss N, OPBS, centre 7)
A minority of surgeons recognised this point and hence the need for RCTs to address important questions.
“[I]t’s almost (laughing) a religious fervour that DIEPs are good and pedicled TRAMs are bad, and yet I’m not aware of any good, even-handed evidence to support that.” (Mr H, OPBS, centre 5)
The majority of participants, however, did not appear to appreciate the methodological limitations of the studies on which their perceptions were based or the impact of selection bias on the results. Some surgeons commented that the absence of robust evidence did not equate to the existence of equipoise.
“Theoretically, anywhere where we haven’t got a robust evidence base from randomised trials, you have to say there’s equipoise, but we know that that’s just not the case.” (Mr I, OPBS, centre 6)
A number of surgeons reported that they felt that things had ‘moved on’ in BR and that trials are no longer necessary.
“I’m all for well-designed studies that prove stuff that answers the tricky questions, but, I dunno, I think it’s almost that things have moved on a bit in breast reconstruction…. We’ve now got this toolbox of techniques, and I think it’s now refining those actually and trying to make sure that patients access the right technique for them, I think that’s more the way things should be moving, rather than having two theories that are equal or that seem about the same…. I think we kind of know that.” (Mr O, plastic surgeon, centre 8)
Limited understanding and acceptance of pragmatic trial design
Although a number of professionals reported that they felt RCTs are needed, many expressed concerns which reflected limited understanding of pragmatic trial design.
“Each patient is unique—they really are, and it’s [not] like a drug trial where we don’t know the answers. I think there’s so many variables for these patients.” (Mr L, plastic surgeon, centre 6)
“Randomisation … in a nonblinded trial is not as robust as people would like to think it is ’cause it’s heavily affected by patient factors and physician factors, so there’s no doubt, epidemiology is not randomised and it gives you robust outcomes. You wouldn’t need to run a randomised controlled trial of smoking or excessive alcohol intake to convince people that it causes damage. You wouldn’t need to randomise people to two bottles of vodka a day—or not so—to have a robust view about alcohol.” (Mr I, OPBS, centre 6)
A number of surgeons expressed concerns about the complexity of the procedure and the impact it might have on the trial results.
“There are so many variables involved with creating a randomised trial…. Scientifically, you’ll be hounded by people saying that there are so many variables in this that it’s not valid.” (Mr L, plastic surgeon, centre 6)
“The problem with trials is that you have to control for everything…. [I]t’s very easy to set up a trial and find that you’ve actually introduced some bias by something that you’ve done wrong.” (Mr O, plastic surgeon, centre 8)
Many participants were concerned about variations in both the surgeons’ levels of expertise and the procedures themselves and felt that these might invalidate or subvert study findings.
“There’s such a variability that I’m just concerned that say you compare implants and lat [issimus] dorsi’s that you’d be mixing some surgeons who are really not good at lat dorsi’s…., an’ then you’re going to end up saying ‘well the implant gives a nicer result’…. It’s going to skew things unless you have a sort of baseline standardisation of training.” (Miss E, plastic surgeon, centre 3)
“You need to have … [surgeons] who are using exactly the same techniques. Some people change the submammary fold, they lift the thoracoepigastric skin and recreate the sub-mammary fold. Now that’s gonna be totally different from someone who’s keeping the old sub-mammary fold in an immediate reconstruction.” (Mr U, plastic surgeon, centre 14)
Others were concerned about selection bias in a trial:
“By selecting out cases that could go into [the trial], you’re introducing bias … because you’re using your judgement as a clinician to decide who could have one or the other rather than it being a truly randomised process.” (Mr D, OPBS, centre 2)
It’s double-blind randomised controlled trials that are the gold standard, and I don’t see nonblinded, if you like, open-label trials as a gold standard ’cause they’re subject to all sorts of problems, particularly about selection.” (Mr I, OPBS, centre 6)
These concerns appeared to adversely influence professionals’ desire to participate in RCTs that they felt would not generate valid or generalisable results and thus would not impact clinical practice.