Background
Methods
The Randomisation Acceptability Study
Survey sampling and recruitment
Interview sampling and recruitment
Data collection
Analysis
Results
Demographics
Identifier | Profession | Sex | Experience if consultant/CNS (years) | Total N of reconstructive procedures per year at their unit |
---|---|---|---|---|
OPBS 1 | Oncoplastic breast surgeon | F | >10 | 11–20 |
OPBS 2 | Oncoplastic breast surgeon | F | 5–10 | 5–10 |
OPBS 3 | Oncoplastic breast surgeon | F | <5 | 50–100 |
OPBS 4 | Oncoplastic breast surgeon | F | 5–10 | 25–50 |
OPBS 5 | Oncoplastic breast surgeon | M | <5 | 25–50 |
OPBS 6 | Oncoplastic breast surgeon | F | <5 | 25–50 |
OPBS 7 | Oncoplastic breast surgeon | F | >10 | 50–100 |
OPBS 8 | Oncoplastic breast surgeon | F | <5 | 11–20 |
OPBS 9 | Oncoplastic breast surgeon | F | <5 | 50–100 |
OPBS 10 | Oncoplastic breast surgeon | F | <5 | 25–50 |
OPBS 11 | Oncoplastic breast surgeon | F | 5–10 | 25–50 |
OPBS 12 | Oncoplastic breast surgeon | F | <5 | 50–200 |
OPBS 13 | Oncoplastic breast surgeon | F | >10 | 25–50 |
OPBS 14 | Oncoplastic breast surgeon | F | 5–10 | 11–20 |
OPBS 15 | Oncoplastic breast surgeon | F | <5 | 11–20 |
OPBS 16 | Oncoplastic breast surgeon | M | 5–10 | 50–100 |
OPBS 17 | Oncoplastic breast surgeon | M | >10 | 50–100 |
OPBS 18 | Oncoplastic breast surgeon | M | >10 | 25–50 |
OPBS 19 | Oncoplastic breast surgeon | M | Trainee | > 100 |
OPBS 20 | Oncoplastic breast surgeon | M | Trainee | 50–100 |
OPBS 21 | Oncoplastic breast surgeon | F | Trainee | 50–100 |
OPBS 22 | Oncoplastic breast surgeon | F | Trainee | 25–50 |
OPBS 23 | Oncoplastic breast surgeon | F | 5–10 | 50–100 |
OPBS 24 | Oncoplastic breast surgeon | M | >10 | 50–100 |
OPBS 25 | Oncoplastic breast surgeon | F | 5–10 | 11–20 |
OPBS 26 | Oncoplastic breast surgeon | F | >10 | 50–100 |
OPBS 27 | Oncoplastic breast surgeon | M | <5 | 25–50 |
Plastic surgeon 1 | Plastic surgeon | F | 5–10 | 50–100 |
Plastic surgeon 2 | Plastic surgeon | F | <5 | 50–100 |
Specialist nurse 1 | Breast CNS | F | Unknown | 25–50 |
Specialist nurse 2 | Breast CNS | F | Unknown | 25–50 |
The need for further evidence in IBBR
Participants also almost universally identified RCTs as the study design that provided the highest levels of evidence.Fundamentally, there is a question where we don’t know which [implant position] is better and which is worse, and we don’t know which ADM [surgical mesh] is better or which is worse. It would be great to know that. – OPBS 19 (M, trainee, RCT possible)
Despite recognising the need for more evidence and an apparent understanding that RCTs provide the highest quality data, opinion was divided regarding the feasibility of a large-scale RCT in IBBR. Consistent with the survey findings, most respondents felt that a study of this type was needed and was achievable, even whilst highlighting certain challenges that may make conduct more difficult. In contrast, fewer participants were opposed to the idea of an implant reconstruction trial, many of whom came from centres performing high numbers of procedures annually.But we always need good quality evidence, and good quality evidence comes from randomised trials. – OPBS 1 (F, >10 yrs, RCT possible)
Partial appreciation of the value of RCTs
Do we really, really need an RCT? I think we really, really need good data collection and to share our data. I think we all should be open for that. None of us need to reinvent the wheel. There’s lots of information out there. – OPBS 7 (F, >10 yrs, RCT not possible)
The value of RCT design in the context of surgery was sometimes felt to be limited due to the nature of surgery as a handcraft discipline. The complexity of the intervention was perceived to introduce a number of variables that would limit the usefulness of any trial results. The concept of pragmatic trial design was often not appreciated or apparently not understood.I think prospective audit is going to give you enough evidence, as long as it is properly audited – OPBS 24 (M, >10 yrs, RCT not possible)
Some surgeons struggled with the concept of applying results from a robust pragmatic trial to an individual patient in clinical practice. Surgery was described as an art as well as a science, and there was a feeling that trial results may not be relevant to individual patients.I do understand the value of it and the order of the hierarchy of the evidence, but I think, for surgeons particularly, it’s a handcraft discipline. It’s not like radiotherapy or it’s not like oncology, where you’re delivering a defined intervention. It’s a handcraft and where you do handcraft, the variables come into play. If, at the end of the day, the variables are so significant then any intelligent researcher would be asking the question, “What is the value? What are we trying to achieve here?” – OPBS 20 (M, trainee, RCT not possible)
The idea of randomisation itself drew concern from some professionals. One professional felt from experience that randomisation would hinder recruitment of possible patients. They described patients interpreting randomisation as a computer deciding their treatment and it was felt this negatively biased them against participating in the trial.In terms of outcomes and things, to my knowledge there are no randomised controlled trials on outcomes, but part of me does think that a lot of this is an art as well as a science. So, I think you can do trials. but I think also it's very much down to the individual patients and their skin quality. – OPBS 21 (F, trainee, RCT possible)
Other concerns with regards to randomisation were more logistical. The timing of randomisation was highlighted as a possible issue as the discrepancy in operation length would affect list planning.The ladies love the idea of the trial, but they don’t want a computer to make that decision for them, so recruitment for [another breast surgery trial] has been slow. – OPBS 4 (F, 5–10 yrs, RCT possible)
But obviously the only difficulty with sub- and pre-pec is would it take much longer in terms of operative time? In which case, you've got to ask the question of when do you randomise, because it may influence the planning of lists and things. - OPBS 21 (F, trainee, RCT possible)
(Lack of) clinician and patient equipoise
A lack of surgeon equipoise was most commonly seen among clinicians from high-volume centres, with more personal experience of the newer surgical techniques.Yes, I think it’s very difficult to get randomised data. I think it’ll be very difficult to do a randomised controlled trial ... Because of the element of surgeon preference and patient choice. – OPBS 9 (F, <5 yrs, unsure about future RCT)
Other surgeons highlighted the disparity between community and individual equipoise. They described the lack of good-quality evidence to support specific interventions, but expressed personal preferences towards specific treatment options when deciding the management of individual patients.I don’t see a reason to go back and do a pre-pectoral on a randomised controlled study. I wouldn’t be able to explain that to my patient, “Well they are equal,” or, “We don’t know whether they are equal,” because I know that it’s not equal. I know pre-pectoral is a lot better. – OPBS 16 (M, 5–10 yrs, RCT not possible)
This was commonly the result of what surgeons perceived to be the ‘obvious’ benefits of the newer procedure. Surgeons often demonstrated a lack of equipoise regarding implant position as they felt confident that specific procedures were more beneficial in certain patients. They felt this would make randomisation difficult.This is all anecdote and I know it’s anecdote, but it’s really difficult if you have that person sitting in front of you. I completely understand that and that is one of the main difficulties isn’t it, that even if it’s anecdotal, you still develop opinions and that sort of stuff? – OPBS 13 (F, >10 yrs, RCT not possible)
As a result, surgeons’ often felt that only a very small subset of patients would be suitable for the trial, with genuine equipoise present.So, I think there are clear differences between the two, in terms of what I perceive to be the benefits of one over the other. For that reason, yes, I suppose I wouldn’t tell my patients that I was in complete equipoise between the two techniques. In which case, they might feel that randomisation wasn’t for me and they were unfair to consider. – OPBS 9 (F, <5 yrs, unsure about future RCT)
Surgeons also noted that patients’ preference must be accounted for, and they must be in equipoise for recruitment into randomised trials.I think for certain cases, they could be randomised but I think the majority of patients, there are factors that would lead you to go one way or another. So, it would be tricky. – OPBS 14 (F, 5–10 yrs, RCT not possible)
The importance of patient choice in the decision-making process was seen by surgeons as a barrier to involvement in an RCT. Trials were only felt to be acceptable if patients could choose their treatment arm, negating the methodological value of randomisation in terms of minimising selection bias and further highlighting a lack of understanding of RCTs.There will be a group where you could do either, and you'd probably get good results from either, but you’ve also then got to factor in the patient’s preference. It’s not just the surgeon who’s got to have equipoise, it’s the patient. – OPBS 26 (F, >10 yrs, RCT not possible)
In contrast, breast care nurses along with some surgeons highlighted that offering trials was crucial in enabling patients to make a fully informed choice regarding their treatment from the full range of options available.So, I suppose my thoughts about the trial is that I would be happy to recruit a patient to either arm, on the basis that in essence they select which arm they go into. So, I would do either but it would be a patient choice as to which arm they went into. – OPBS 19 (M, trainee, RCT possible)
I think what's important is that patients know the options. Then if they choose to take them or not, at least they know those options are there. If anybody is eligible for a trial, we always offer that, even if the patient just says, “No, thank you. I don't even want to really know about it. I want to just focus on what is the standard pathway.” Then that's fine, but it's about knowing the options. – Specialist nurse 1 (F, n/a, RCT possible)
Some clinicians did not appreciate the difference between their role in clinical practice and as a recruiter to an RCT. Trial recruitment was seen to be difficult as they tended to highlight the pros and cons of different treatment choices and then patients formed a preference based on this.If you're not offering, you are depriving patients’ choice. – OPBS 23 (F, 5–10 yrs, RCT possible)
Clinicians, who were often senior with more experience of reconstruction, also reported providing a steer to patients who were preoccupied with their cancer diagnosis. Highlighting that these patients did not have pre-formed ideas about treatment, but were instead guided by their clinician.When you start talking to them about the differences between pre-pectoral and sub-pectoral and say, well this is much less painful, but you might see some rippling, they go, oh well I’ll go for that. – OPBS 15 (F, <5 yrs, RCT not possible)
They don’t come with preformed ideas about what they want. Not at all ... They’re so wrapped up in their cancer or DCIS [ductal carcinoma in situ] diagnosis that it’s often the talk about reconstruction is secondary, so we very much guide people. – OPBS 2 (F, 5–10 yrs, RCT possible)
Inherent surgical culture
This reliance on personal experience was seen as a barrier to trial participation, as surgeons would be apprehensive about changing the surgical technique they are accustomed to and worked in their hands.I think the sort of whole surgical mind-set is that during your training you see other people doing different things and you work out what you think is the best thing for whatever reason, and then have a kind of dogged determination to stick to your approach, whatever it is, without it really being evidence based or tested or audited in a kind of multicentre way. What works in your hands, works in your hands – Plastic surgeon 1 (F, 5–10 yrs, RCT possible)
One surgeon felt that prior clinical experience was a major factor in this. More experienced clinicians were felt to be more likely to rely on their extensive clinical experience and would not be in sufficient equipoise to recruit.That’s an interesting one. Probably not, to be honest. I think you’ll find a lot of resistance from people doing what they’re used to doing. – OPBS 3 (F, <5 yrs, RCT not possible)
Another barrier to trial participation raised by a number of surgeons was the logistical issue of recruiting patients to trials when facing patients already burdened by a new cancer diagnosis. Surgeons described having difficulty with recruiting as a result of the treatment deadlines and the burden of information that needed to be conveyed to the patient.My comments would be yes, it would be possible [to recruit to trials] and there are certainly plenty of surgeons out there that aren’t established in one or the other, so you probably would find people who are still relatively naïve that would be able to recruit, but I think some of the rest of us that are a bit longer in the tooth might find it a bit more challenging. – OPBS 13 (F, >10 yrs, RCT not possible)
Even senior surgeons acknowledged their discomfort when discussing complex surgical trials with patients. This in itself was seen as a barrier in some cases.I think we need to remember these patients, we’re bound by 31 and 62 day targets and we’re throwing a whole load of information at them. We give them a cancer diagnosis and we give them a lot of information about their reconstruction … I think adding in a trial on top of that can be really, really confusing for the patients. – OPBS 7 (F, >10 yrs, RCT not possible)
However, this was also seen as a key communication skill and was acknowledged as something that all surgeons should learn and possess.I’m not sure an RCT will be easy. The ones we’ve tried to do with regard to [another type of breast reconstruction], it’s very, very difficult. I’ve sat and tried to have a preliminary discussion with patients prior to [the] trial and I was confusing myself, to be honest. I think an RCT would be difficult. I’m not saying it would be impossible, but I think it would be very difficult. – OPBS 7 (F, >10 yrs, RCT not possible)
Only one surgeon openly acknowledged the possible discrepancy in their role as both a clinician and a trialist. It was apparent that, despite realising the need for an increased evidence base, there was some reluctance to recruit to clinical trials for fear of less positive clinical results.I think it's all about how you explain it to the patient, but it's absolutely achievable. If people say you can't do it, it's they can't do it. They're failing to do it. It's a communication skill that everyone should have and should learn. – OPBS 23 (F, 5–10 yrs, RCT possible)
Losing one [an implant], that’s massive. So, it’s a bit scary, but that doesn’t mean I don’t think getting that evidence is valuable. I appreciate it is unacceptable for me to say, “I want that evidence,” but I don’t want to lose my results. Someone else can do the dirty work. (Laughter) – OPBS 4 (F, 5–10 yrs, RCT possible)