Table 5 Factors that patients consider when ‘weighing up’ their participation in a RCT

Altruism

Patients valued and understood the need for clinical research and participated for reasons such as wanting to advance medical knowledge and/or help others.

Only a small number of staff used altruism in recruitment consultations.

“It seemed to me that the frame was the best option and I didn’t really want to take that risk, but then I felt bad, not bad but – because how on earth is research going to develop if people don’t take part in research projects” (ACTIVE patient interview, decliner)

‘Doing what’s best for me’

PRESTO patients described participating to “sticking two fingers” to family members who had strong treatment preferences and because they thought they would receive better care if they were part of a trial. Others seemed indifferent towards participation and claimed ‘I’m going to be lying on my back anyway, so what the heck’

“They were explaining to me that it would be helping other people, but I said actually at the time I was more interested in what was best for me, rather than what was best for other people. But I was happy to go ahead with the trial and that I did want an operation. And if they did come back and say that it would have been the brace and not the operation I would have said that I didn’t want to be part of the trial.” (PRESTO patient interview, accepter)

Personal circumstances/daily life

Of those that declined to participate in ACTIVE many based their decision on the perceived impact of the intervention on their daily life. For example, the ability to mobilise and/or wear normal clothing. Comfort, ease of commuting, positive experiences of previous surgery and specific concerns about compliance and the impact of the brace on daily life (PRESTO) were cited.

“I said I would rather have the operation. I know It sounds…I had an operation on my lower back ten years ago which was completely different. I researched – because I’m a single dad – I mean, my daughter’s with her other dad now who lives abroad for her six week holiday, which is actually a good time. That was planned anyway. You know, I didn’t want to be limited because I am a single dad, and I run a business. So, it’s like I wanted to recover as soon as possible”. (PRESTO patient interview, accepter).

Perceived recovery time

Perceived recovery time and return to work were key concerns across both trials. Both ACTIVE and PRESTO patients that we interviewed had preferences for surgery due to a perceived quicker recovery time.

“If anything had been quicker, I just wanted to get out of there, there and then […] If anything had been quicker I would’ve been like that, ‘Oh, do it. Get me out of here’, really” (ACTIVE patient interview, accepter)

Friends, relatives and other external sources

Opinions and vicarious experiences of friends, relatives and other non-professionals and patient’s own research influenced patient decision making. In ACTIVE, people were influenced by others that had received either treatment for other fractures.

“[My wife] was Googling everything up under the sun about it for me as well and she came to the same decision as me. She thought it was a good idea that I’d chosen that, the external frame method because it just did seem like hacking into my leg was a bit too much” (ACTIVE patient interview, decliner)

The impact of interventions on body image

During ACTIVE, concerns about scarring from internal fixation and how others may react to the external frame were prevalent. Recruiters reported trying to address body image related concerns by involving limb reconstruction nurses in recruitment consultations, where possible

“I just couldn’t see how anybody could possibly live with this barbaric contraption. It looks like a two-year old’s pedal bike just wrapped around my leg” (ACTIVE patient interview, accepter).

Addressing treatment preferences

For the majority of patients, preferences were considered changeable and examples of patients changing their mind were provided. Trial recruiters dedicated part of recruitment consultations to addressing this by discussing the pros and cons of each treatment and tailoring information to the concerns of individuals.

However, staff explained that there will always be a subset of patients with strong, unchangeable preferences. Those which based decisions on personal (e.g. children, fear) rather than clinical reasons were considered particularly difficult to change.

Sometimes patients feel that they have expert knowledge of their own body and so believe there must be a ‘best’ option for any given individual. These patients often want to maintain control of their own health and do not want others making decisions for them.

Staff and patients provided examples of situations where participation depended on allocation aligning with the treatment preferences of patients. Some patients claimed they would have withdrawn if they had not been randomised to their preferred treatment.

“I said, oh I’m pretty much having surgery and he kind of went “well no”. He took me through the options. So they were very clear the way they described it and it was interesting because there was a lot of debate because my sister was there and my sister was calling my mother and my sister and mother wanted me to have surgery because they knew somebody who had a brace for scoliosis and said it was extremely uncomfortable and their entire life, you know, the period they were in a brace was pretty frustrating and so yeah there was definitely….from the three members of the medical team in the room and [name] was quite good at arguing, not arguing, but basically giving the other opinions to my sister and my mother who were kind of blasting me in one ear.” (PRESTO patient interview, accepter).

Minimising risk of randomisation

Some associate randomisation with a loss of autonomy. Both patients and clinicians described how making patients aware that clinicians have the final say in patient’s treatment and that irrespective of their allocation they will receive the clinically appropriate treatment was important along with emphasising a patient’s right to withdraw.

In PRESTO, patients were informed they could switch treatments if deemed clinically necessary during recruitment for those allocated to surgery or follow-up for those allocated a brace.

In ACTIVE patients had been ‘put off’ participation by a treatment being portrayed as more risky – this was perceived to undermine equipoise by suggesting a surgeon feels one treatment is better than another.

“We are guided by the computer, purely because both the treatment options are correct.” That makes them feel a little bit more in control, like if you say that one is better than the other, “Why am I being randomised then?” When you say to them that both the options are pretty equal, then they are happy and they know that there is always that opportunity to cross over, because you do say to them that, “If during the follow up process that we are treating you with a brace, if we believe that things aren’t going in the right way, then trial, no trial, we’ll switch you to whatever’s appropriate.” That is the good thing that the patients recognise, that their treatment is carrying on as it should be, whichever way the trial goes, whether you go in the trial or you don’t go in the trial, everything put together. I think that should reassure them that we are more trying to treat them appropriately rather than the trial. The trial comes second.” (PRESTO staff interview).