Table 2 Key findings relating to randomisation

Understanding randomisation

For most patients randomisation was a new concept

“They told me it was 50/50 whether they would give me surgery, or I would be in a brace, and it was chosen quite randomly by the computer. No human influence on that, at all. They obviously said that my care and everything would be exactly the same as if I wasn’t on the trial.” (PRESTO patient interview, accepter)

Trial jargon

Across both trials, staff felt patients equated randomisation to being experimented on and to remove their choice and decision making around treatment. Using the analogy of a toss of a coin was considered flippant and unprofessional – ACTIVE patients felt gambling metaphors undermined the severity of their injury whilst trial recruiters felt that describing something as random implies it is intrinsically bad or inferior.

Using computer-based terminology invoked fear with some patients who were reluctant to be randomised due to a mistrust in computers and technology – patients wanted treatment to be based on an informed choice by a qualified and experienced person.

Clear explanations of terms such as randomisation, are more likely to promote transparency, understanding and acceptance. Some ACTIVE trial recruiters thought that they should not use the word randomisation and in some cases avoided discussing that patients would be allocated to treatments by a computer as they were aware of the potential negative implications of this terminology on recruitment.

“I think when you try to say randomised and talk about the computer allocating it, people worry. It frightens people, and I wonder if maybe my experience of that is within a study that general has recruits who are in an older age bracket and may be a little bit more unsure of technology and computers and want the doctor to make their decision”. (ACTIVE Staff Interview)

“It did seem kind of not as professional. Like, “We’re going to do this really serious thing on you”, this was serious and obviously all operations and procedures like that, it must cost a fortune, and for them to basically just, it was almost like it came down to “flip the coin”” (ACTIVE Patient interview, accepter)

Recall of randomisation

The severity of PRESTO patient’s injuries, the medication they were prescribed and presence of other injuries led to the capacity of these patients and whether they made informed decisions about their treatment and trial participation to be questioned.

Many PRESTO patients found it difficult to engage with study materials and/or were unable to remember details of recruitment and randomisation.

“But it probably would have been better if it was explained when I had someone with me, because as I say, I was very sleepy. I’d had lots of morphine, and I think I could just about keep my eyes open when they were talking to me.” (PRESTO patient, accepter)

PRESTO staff did not consider the patient’s capacity to be an issue as they felt obtaining informed consent and determining capacity during recruitment mirrored the processes used in routine practice.

“I don’t think that (capacity is) a problem most of the time. If you think about it, to do anything you have to get informed consent, whether it’s a trial or not. If I operate on someone, I have to get their consent. If I’ve discussed surgery or not surgery, implicitly they’re consenting to have not surgery if we pursue bed rest. Things can always change. I mean you can operate further down the line.” (PRESTO staff interview,)