Nine participants and two personal consultees from five of the seven centres participating in TrAFFix were interviewed. Of the participants who were interviewed or whose consultee was interviewed on their behalf, two were male and nine were female. They were all of white ethnicity and aged between 54 and 93 years (mean age of participants: 76.3 years). One participant went through the interview questions with her daughter who gave the answers to the researcher in writing. Participant characteristics are presented in table 1. Prior to their fracture five participants were classified as frail (either mildly (n=1), moderately (n=1), severely (n=2), or very severely (n=1)) using the Rockwood frailty scale (16).
Table 1 here
Twenty-four members of staff participated in an interview; all of the seven centres had at least two members of staff who were interviewed. At each centre, this included the chief or principle investigator (PI) (a surgeon responsible for the day-to-day running of the study at their site) and a member of staff whose role was to recruit patients to the study. Of the 24 staff who were interviewed 10 were surgeons and the remaining 14 staff, hereafter referred to as research associates (RAs) to protect anonymity, included research nurses, an RA, a physiotherapist, a research manager and a trial coordinator.
Facilitating trial recruitment
Navigating research with patients after orthopaedic trauma
Navigating involved engaging with patients and their family to: i) support them in making sense of the study and ii) and enabling them to participate.
Making sense of the study
Patients eligible to participate in the study were described by staff to be typically frail, older patients. At interview, participants and carers tended to recognise or recall the two interventions, knowing that one involved a piece of metal that attaches to the outside of the bone and one involved a piece of metal that goes through the middle of the bone. However, they could rarely describe the study in their own words. Several participants explained that around the time of their surgery, they were “that full of drugs I didn’t know what day it was” (participant 8) or not “in a fit state” (participant 5) to ask questions, reinforcing the difficulty in engaging with information at the time. Patients struggled to make sense of randomization and gave contradictory accounts of how their treatment was allocated despite it being explained to them again at interview. Some participants demonstrated the therapeutic misconception[i], believing that they or their relative would receive the best treatment for them. Others seemed confused about the alternative to trial participation, which they understood to mean no surgery rather than the surgeon choosing a method of fixation.
They had to decide because they know what they are doing and I don’t.
I don’t mind, I don’t know what else they would have done with it. I know they didn’t put a plaster on my leg or anything like that.
Staff felt that this group of patients were unlikely to comprehend and recall all elements of the study given their frail and at times confused state. Staff described knowing that both treatments are routinely used and that their surgeon was happy for them to participate as important to patients. They understood that the type of metalwork used to fix their fracture was unlikely to be a priority for patients who may not be able to appreciate the difference between the two interventions.
Remember we are talking about the specific cohort of patients…when you have surgery, the drugs, the pain killers, a bit of fear, uncertainty all of these might be more important than whether you had a plate or a nail you know.
Some people are very trusting of the surgeons and don’t really care and don’t really understand the difference between a plate and a nail and as long as their problem gets fixed and something is being done they’re happy with either one or the other. It would be different if it was like you’re either getting a cast or an operation, that’s the difference but if they have an operation anyway …
At interview, participants expressed altruistic motivations for participation, wanting to help future patients or science. While they did not always understand and recall the study, they knew that they were helping in some way. Staff appreciated that patients wanted to help others and endeavoured to give them the opportunity to participate.
I would love to, love to help and you know if there is anything I can do for, you know, research and things it helps doesn’t it, it helps other people.
I think that they know they’re helping, some of them have a bit more insight into some of the surgical studies maybe, but lots of them put their faith in the medical team that they know what’s best, “I don’t mind as long as I’m helping” they say, “I don’t mind as long as I’m fixed”.
RAs sought cues from patients to determine whether they could retain and weigh up information about the study in order to make an informed decision about participation. This included checking that patients could recall the study, spending time chatting with them and paying attention to the questions they asked.
If they’re already in a study or it’s an observational study what we do when we’re not time pressured we actually go to see them one day, give them the information sheet, have a chat about the study. We go back the next day and if they’ve retained any of that conversation from yesterday or they remember who we are or they say they’ve read that sheet we gave them yesterday then that's our little method of assessing their capacity. We find that’s really useful for the borderline patients.
The majority of staff found involving relatives in the discussion about the trial enabled patients to be supported in their decision-making. They found this was particularly helpful for older patients who were often concerned about signing or agreeing to something without the involvement of their relative (typically their adult child).
Sometimes you find that people can be quite nervous because… they’re told by their children that if somebody rings you up over the phone, don’t agree to do anything, don’t sign up for any contracts, don’t do anything… and all of a sudden you’re saying sign this and you can tell that they’re a bit guarded because it’s not something that they would normally do. Sometimes you can find it easier if you approach them to try and time it around their visiting hours and so they’ve got a relative with them and so you can kind of talk to them as a family and a lot more patients feel more comfortable with that.
A minority of staff, in contrast, found that it was easier to consent patients to studies without involving relatives. In their experience, involving relatives led to more patients declining. They found that relatives could be protective and felt that a research study may be too much for them after enduring trauma. Additionally, some staff found that relatives could also struggle to understand trials themselves.
Through family, I have experienced more people declining generally for the fact that they’ve got a relative that’s undergoing something that’s really quite traumatic for the family and they don’t feel that they would want to put them through something else that is going to mean follow up or something else like that.
Patients who were entered into the study under nominated consultee agreement due to a lack of capacity and available personal consultee prior to surgery were approached to continue in the study when they regained capacity. RAs described feeling nervous, uncomfortable and guilty about approaching patients after surgery for consent to continue in the study. However, they found that the majority of patients accepted this procedure and did not mind having been already included.
At first, we were quite sort of worried approaching people saying you’ve been randomised but actually... I don’t think we’ve had anyone that’s been miffed or upset.
Knowing it is the right decision
Knowing that it is the right decision involved a process of interpreting the eligibility criteria, consideration of surgical preferences, skill and beliefs about equipoise with the intent of providing the best care for patients.
Interpreting the eligibility criteria
In this study, gaining confirmation from surgeons that patients were eligible for inclusion was challenging. Surgeons’ interpretation of the eligibility criteria was shaped by their beliefs about the suitability of both interventions for certain fractures. Patients with complex fractures were considered eligible by some surgeons but borderline by others.
This study is focusing on a very narrow range of patients so they are very infrequent patients. Not all patients are suitable for both so patient selection is very difficult, sometimes they are borderline.
There are certain patients that would be eligible based on the criteria but whom people are saying no but this obviously needs a plate or no but this obviously needs a nail you would never do the other thing for this fracture. Now I appreciate that this may not be across sites but certainty within this site my perception is that patients are screened eligible but aren’t included because people are going that just shouldn’t have either nail or plate?
Surgeon’s own surgical preferences influenced their willingness to take part in this study. At interview, staff suggested that for simple distal femoral fractures, surgeons were typically in equipoise, were confident they could perform both procedures and were willing to randomise patients. However, staff reported that for complex fractures, surgeons were less willing to randomise patients. They explained that some surgeons believed that one method of fixation was more appropriate than the other for these fractures or that only one method of fixation was appropriate and “you would never do the other thing for this fracture” (Surgeon 8). Staff believed other surgeons either considered complex fractures too difficult to fix with a nail or had little, if any, experience of using nails.
To give you an example the other day a patient came in with a periprosthetic knee and people felt unhappy to put a nail in… because they had never done it before.
Surgeons emphasised that these fractures are uncommon and therefore most surgeons would have little experience fixing them. Furthermore, two surgeons explained that unlike many other operations, this operation is not performed from implicit[ii] memory, which could make it more difficult for surgeons to use their least preferred technique.
Distal femoral fractures are not common and so there are only about 10 percent of fractures of the femur overall and so no-one is doing lots unless you put your hand up to do them.
It’s not like a routine thing like an ankle fracture that you don’t really think about, it’s not like a brain stem reflex.
Some staff described surgeons making decisions about treatment and trial participation as a group. In some centres, consultants were described as holding a collective preference for one of the two interventions or a consensus as to which patients they were prepared to include in the trial. Collective preferences for one of the two interventions could hinder recruitment, as it may be difficult to make the decision to randomise patients without the support of the group.
…And someone else would pipe up well they’re eligible for TrAFFix and there’s a collective sigh of let’s hope it’s a plate then and so they have their preferences.
For me I think that the real issue is that a consensus opinion falls before (TrAFFix) is considered), so everyone says this is what I think we should do so when you say so would you be happy to be randomised the consensus is no.
Of the surgeons interviewed, four expressed a personal preference for one of the two interventions but were still willing to randomise patients. This suggests that some surgeons accepted community equipoise[iii] and were able to proceed with their less preferred intervention. Furthermore, two surgeons emphasised that as individual equipoise can be difficult to achieve in surgical trials, it is important to accept community equipoise, which can give surgeons a reason to randomise patients.
I don’t think when it comes to individual patients then surgeons can have that (equipoise), they always have an opinion about what they prefer to do because that’s what we’re trained to do. But I think the big real change for me over the… years really working in trauma research is that people have embraced this idea that as a community it’s okay for me to randomise my patient because as a group we don’t know. So the fact that I might have a preference individually at that particular moment for that particular patient with that particular fracture it’s still okay to randomise because as a community we don’t know.
Making it work
Making it work involved juggling a range of activities, balancing recruitment with concerns about study burden, and developing a research culture within the department.
RAs endeavoured to minimise the impact of research on clinical staff by juggling an array of activities and ensuring they fit in with clinical staff and their activities. They avoided taking too much of consultants’ time and tried to help where they could, for example by taking patients to the toilet or asking for pain relief or other medications for patients.
You’ve got to try and make sure you’re not taking up their time because if the consultants have been delayed because of research and things their clinics are running over, the staff are having to stop later and it impacts (on) everybody and so I’m trying to make as little impact in the clinics as much as possible and on the ward areas. If you try and help for example with taking people to the toilet, you might go and see a patient and they say they want the bed pan and so you end up helping.
Balancing their own beliefs with their recruiting role
RAs endeavoured to balance their role of recruiting to research with their own beliefs about patient care. Some RAs described feeling caught between trial managers who wanted numbers and patients who needed care and time to reach a decision. They felt showing reciprocity and care to patients who had been approached about research during a time of vulnerability was important.
Yes if I am with patients, I am with patients and that’s it because I want to have something with them and they deserve my time, I have to be there for them and to answer all their questions no matter how long it takes.
They also considered the appropriateness of research participation for patients with terminal diagnoses or multiple injuries.
I’m a nurse and so obviously it’s a big consideration of mine if it’s not appropriate, if patients have had a terminal diagnosis then it’s very tricky when some of our studies follow the patients up for four months or six months.
Additionally, for two RAs, being aware that their surgeons may not have equipoise was troubling. They explained they would feel uncomfortable approaching patients or their relatives about participation in a trial if they were aware that their surgeon might prefer one of the two treatments. While they trusted the surgeon’s judgement, they needed to know that they were not causing harm to patients by asking them to participate.
Yes for a surgical thing I would be very uncomfortable to approach someone saying the doctor’s happy to do either knowing that (the) surgeon had said I wouldn’t want to do that, I would rather do that. I wouldn’t like that at all.
No, I think we need to know as well that the surgeons themselves could and will do either quite happily to a high quality because from our own emotional state that’s someone’s mother, someone’s daughter, someone’s loved one. You really want to know that what we’re doing is not causing any harm.
Developing a research culture, where clinical teams are engaged in research could facilitate the delivery of research studies. In some centres, this was a “work in progress” (RA 4) while in others, staff described research to be routine. Three features that may foster the development of a research culture with departments were raised.
First, staff suggested that surgeons working in hospitals that are participating in several studies might become more involved in research and might identify or recruit patients for their colleagues’ studies as well as their own.
And it’s taken a couple of years, there’s been a bit of resistance but now the PIs are getting on board and it’s “I’ll recruit to your trial if you recruit to my trial” and it’s a snowball effect.
Second, communication from research teams was as a way in which clinical staff could gain a better understanding of the research going on so that they feel informed.
I think in the bigger department there’s a lot of scepticism, people can be quite – not obstructive exactly but maybe they feel the researchers don’t communicate very well to them and so there seems to be this issue that people feel the studies happen and they weren’t told about it.
Third, staff also emphasised the importance of strong, research teams to facilitate the development of a research culture and maximise recruitment to studies. Research teams endeavoured to promote studies, prompt recruitment and do the groundwork for surgeons.
There’s a sort of assumption that we do all the groundwork for the surgeons, we highlight all the patients, we go prepared to the morning meetings so that we know what to expect and again it’s having that knowledge behind you that gives you the confidence to do that.
[i] “When a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures” (17).
[ii] Implicit memory uses previous experience to perform an activity without thinking about it.
[iii] uncertainty within the expert medical community