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Table 4 Key findings relating to equipoise

From: Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Equipoise
Sub-theme Description Exemplar quote
Patient understanding of equipoise Emphasising that clinical teams consider both treatments to be appropriate for the patient, are effective, routinely provided and lead to good outcomes is important. “The main point that we put across to the patient when we discuss randomisation is that at the present moment, the debate regarding the surgery or conservative options is pretty equal among the way consultants have been practising all across the UK. So there has been no preferred treatment for either of those options. And that is what we were trying to find, and detailing the options as both an equally suggestive and successful treatment options then makes the patients more receptive to the idea of randomisation.” (PRESTO staff interview)
Communicating uncertainty Disagreement as to what is considered a stable thoracolumbar fracture, concerns that study treatments are not comparable and the perceived inherent opinionated nature of surgeons meant that surgeons found it difficult to discuss the uncertainty surrounding treatment options and culminated in subtle attempts to undermine equipoise.
PRESTO patients gave examples of surgeons expressing preferences for the opposing treatment to what they had been allocated post-randomisation. ACTIVE patients sensed relief, annoyance and disappointment from staff depending on their allocation – they felt relieved when their allocation matched the preference of the recruiter.
“I don’t think [Surgeon] was very happy because I was going through a trial and he wanted to put the external frame on. Then they put the plates in. […] you’re doing this trial, and he wanted to put the cage thing on my leg. I was like, “Why doesn’t he do it then, if he thought it was going to work better?”[…] I can’t really remember, but he was really off with me though”. (ACTIVE patient interview, accepter)
Remaining neutral In both studies, patients felt staff conveyed preferences for specific treatments. For example, some PRESTO patients described either not being given a choice of treatment, or explained how after being allocated to one treatment the surgeon stated that they would preferred them to have the other.
Patients challenged staff neutrality by asking them what treatment they would routinely recommend.
“My partner who was there all the time was given a choice of having the surgery for my back or a brace and he said “No, they said surgery.” (PRESTO patient interview, accepter)
Variation in routine practice In general, PRESTO surgeons were positive about the need for a trial and saw it as crucial to address variation in practice. It was suggested that there is a proportion of surgeons at every hospital who would not be willing to randomise or be part of a trial—some surgeons not involved in recruitment to PRESTO felt it was inappropriate to ever operate on stable fractures, others had different views. “I don’t think there’s much variability at all for stable fractures, except for a few places in the country, nobody operates for these patients. If I asked everyone, except for five or six or ten surgeons in the UK they operate for stable fractures, otherwise people don’t operate. So those ten surgeons you can identify first in the UK and then run the trials using those surgeons then you can finish the trial. Otherwise you don’t want to start the trial and then take two or three years to recruit the patients, if you still want to run this trial.” (PRESTO staff interview)