Nine patients and two personal consultees from five of the seven centres participating
in TrAFFix were interviewed. Of the patients or their consultee (n=23) from the main
study, six declined to be approached to take part in an interview as they felt it
was too much of a burden, while 17 agreed to be approached. Subsequently one of the
17 patients died, one withdrew before being approached by the researcher, two declined
when approached due to fatigue and two could not be contacted. Of the patients 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 patient who had capacity and provided
consent to take part in the trial, was frail and unable to withstand an interview.
As she still wished to take part her daughter went through the interview questions
with her and gave the answers to the researcher in writing. The team felt this compromise
was important to ensure the contributions of frail patients were included. The characteristics
of this patient are included in table 1. Prior to their fracture five patients 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: Patient characteristics
Twenty-four members of staff participated in an interview; all of the seven centres
had at least two members of staff who were interviewed. In five sites additional members
of staff were identified who had a range of experience of recruiting to TrAFFix. No
staff members declined to participate. 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
Three themes that facilitate trial recruitment were identified within the data: i)
navigating research with patients after orthopaedic trauma, ii) knowing that it is
the right decision and iii) making it work. The codes, categories and themes within
facilitating trial recruitment are presented in table 2.
Insert table 2: The codes, categories and themes within facilitating trial recruitment.
At interview, patients focused on their experience of being injured and recovering
from their fracture with little importance placed upon the trial. Patients’ and consultees’
experiences of the trial are reflected along with staff experiences within the theme
‘navigating research with patients after orthopaedic trauma’, while the themes ‘knowing
it’s the right decision’ and ‘making it work’ were developed from the staff interview
data. Quotes are included to illustrate our interpretation of participants’ accounts.
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) 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, patients and consultees 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 patients explained that around the time of their surgery, they were “that
full of drugs I didn’t know what day it was” (patient 8) or not “in a fit state” (patient 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 patients and consultees demonstrated therapeutic misconception, believing that
they or their relative would receive the best treatment for them. This occurs “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). 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, patients and consultees 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
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
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
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 memory,
which could make it more difficult for surgeons to use their least preferred technique.
Implicit memory uses previous experience to perform an activity without thinking about
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 (where uncertainty about the best treatment
is held across the expert surgical community) 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
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
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, enhanced communication from research teams to clinical staff might lead to
a better understanding of ongoing research and engagement in the research process.
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
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