Recruiters’ responses to expressed treatment preferences
There was a clear difference in how recruiters responded to the expressed preference between the trials. In trial 1, participants expressed a treatment preference in either the appointments with the surgeons or the follow-up phone calls with the research nurse. Recruiters (mostly the research nurse at follow-up) readily accepted participants’ preferences without further discussion and exploration of the reason behind it in all of the eight cases:
‘RESEARCH NURSE: Have you had a chance to look through the literature you were given in the clinic about the different treatment options?
A03: Yeah I did....I mean I’d like to go for [minimally invasive surgical option].
RESEARCH NURSE: Okay that’s fine. I’ll let [recruiter’s] secretary know that.’
(Trial 1, patient chose preferred treatment)
‘A06: I’ll go for [minimally invasive surgical option]
RESEARCH NURSE: [laughs] Can I let you think about it and I’ll give you a ring. [At follow up phone call] Have you had a chance to read the literature I gave you about the study and the treatment options?
A06: I have yes
RESEARCH NURSE: Okay and what would you like to do?
A06: Um, I think I wanna go with um [minimally invasive surgical option]
RESEARCH NURSE: Okay.’
(Trial 1, patient chose preferred treatment).
Some participants, unprompted, stated the reason behind wanting a particular treatment, but in half of the cases the rationale for the preference was not apparent and it was not possible to know whether they fully understood the other treatment option or the existence of the RCT.
In trial 2, preferences were expressed then accepted by recruiters without any discussion or exploration in 8 of the 21 consultations. This occurred in both centers and by a variety of different recruiters. In one of these cases the recruiter agreed to the participant receiving their treatment of choice before providing full details on the treatment, and in another the recruiter actually agreed with the participant’s treatment choice and in doing so revealed their lack of equipoise:
‘B08: I made up my mind at the weekend when I read about the [non-surgical option]. I just don’t want it.
ONCOLOGIST 1: You don’t want it. No, no. That’s fine.’
(Trial 2, study centre 1, patient chose preferred treatment).
‘B10: Because from what I can gather it’s not that bad, it hasn’t spread anywhere else. So the chances are this, this [non-surgical option] could cure it.
ONCOLOGIST 3: That’s absolutely right
B10: You know if it had gone anywhere else I’d, I would have said straightaway well go for that [surgical option]….
ONCOLOGIST 3: Yep, yeah I understand that it’s a worrying time isn’t it. So you would rather go for the [non-surgical option]?
B10: I think that’s the best thing to do.
ONCOLOGIST 3: Yep ok, that’s absolutely fine…. I think that’s the right thing to do actually.’
(Trial 2, study centre 2, patient chose preferred treatment).
There were attempts by the recruiters to address the expressed preference in the remaining 13 recruitment consultations by balancing participants’ views on the study treatments, for example, by stating the disadvantages of their preferred treatment or the advantages of their less preferred treatment in response to a voiced preference. They also highlighted the position of clinical equipoise (not knowing what the best treatment was) and hence the rationale and importance of the trial:
‘B01: I want rid of it, to have surgery to get it - having the surgery and getting it cut away…
SURGEON 1: Well, I will tell you honestly that I do not know which is better and I’m a surgeon but I feel that - erm, that we need to try to find out which kind of treatment is better.’
(Trial 2, study centre 1, patient chose preferred treatment).
However, the discussion did not usually go beyond this initial counterbalancing and it tended not to be tailored to the individual’s specific concerns. In most cases recruiters accepted the preferred treatment soon after providing the counterbalanced information, often without discussion of the underlying rationale for the preference and therefore understanding of the reason for the preference:
‘ONCOLOGIST 3: Would you be prepared to think about letting the computer decide whether you have an op or the [non-surgical] treatment?
B05: Well we’ve had a chat with friends, family and everybody really and - I think the operation we had decided, we thought maybe it’s one operation and that’s it, it’s gone hopefully. We looked at some of the implications with the [non-surgical option], like you said they’ve all got complications with whichever one you have. But I think the operation was the favorite one
ONCOLOGIST 3: So - I - I’m, shall I just give you a contrary view? Would that be helpful?
B05: Yes, yes.
ONCOLOGIST 3: I’m quite happy if you make that decision that’s absolutely fine, ok. So there are two things one the surgery has a very high complication rate, and the quality of life probably dips more with surgery than it does with [non-surgical option], ok. It’s true that you imagine you have the cut and it’s all over and done with, but in many ways [non-surgical option] is aiming at having the same effect…… they each have their pros and their cons and they’re both very different. And that’s really why we need to do the trial so you come here and you say well look what’s the best treatment for me and I can say, well it is - because at the moment we can’t really do that you see.
[Short discussion omitted with patient’s wife about being given several treatment options]
ONCOLOGIST 3: Yep. [7 second silence] So you’re sticking with plan A then [surgery]?
B05: Yes, yeah.’
(Trial 2, study centre 2, patient chose preferred treatment).
In a minority of cases preferences were not simply accepted by the recruiters straight after providing counterbalanced information, they continued instead with further discussion of the treatments and the trial. The recruiters’ responses appeared to have a marked effect - the participants began to consider other initially less preferred treatment - but they still opted for their preferred choice in the end. In only one of the 21 consultations in which preferences were voiced did the recruiter attempt to explicitly explore the underlying rationale for the preference before then accepting it:
‘ONCOLOGIST 4: Have you had any thoughts about it [participating in the trial]?
B12: Well, I’ve had a lot of thoughts about it and it’s always been a little bit, I don’t know. It’s, I don’t know, I don’t know. But I’ve eventually, at the moment anyway, unless I heard something completely different from somebody - erm, to go for the [non-surgical option].
[Short discussion omitted on random treatment allocation]
ONCOLOGIST 4: Ok. You’d rather stick with the [non-surgical option]
B12: Go with the [non-surgical option], I think. Yes.
ONCOLOGIST 4: So, do you want to tell me why that is?
B12: Not really because, erm I don’t know enough about it to be able to, sort of, give you a - a, sort of, serious thing. I just feel that I’d rather, sort of, go for that than - than the surgery part - it’s as simple as that.
ONCOLOGIST 4: Ok. What, in particular puts you off the surgery?
B12: Erm, I’m not particularly - I don’t think I’m particularly worried about surgery, as such, erm, but I think - well, [sighs] the surgery, as I understand it, would be, sort of - cut up here, sort of, to one thing get that out and then two more places as well to move - and I think, well, is - if the [non-surgical option] can do the same thing without the cutting that’s my only reason, really [in picking it].
ONCOLOGIST 4: Ok. That’s fair enough.’
(Trial 2, study centre 2, patient chose preferred treatment).
In this trial (trial 2), preferences were more commonly expressed in the second appointment with the oncologist than in the first consultation with the surgeon, likely in part because participants had had time to absorb the information and formulate a view. However, oncologists were more likely than surgeons to readily accept a preference at face value and not explore it; oncologists accepted a preference without discussing it further in 6 out of 13 consultations compared with only 2 out of 8 consultations with surgeons in which preferences were not pursued. Consultations appeared independent of each other in terms of discussion of treatment preferences; having voiced, and in some cases discussed, a treatment preference in the first appointment with the surgeon did not appear to affect whether the oncologist in the second appointment explored the patient’s preference or accepted it at face value. As with trial 1, all of those who expressed a treatment preference in trial 2 declined trial participation in favor of their preferred treatment.
Analysis of recruitment appointments in trial 3 (ProtecT) revealed much further exploration and discussion of expressed treatment preferences overall. Participants often came to the appointment with a particular treatment in mind. The expressions of treatment preferences were not dissimilar to those in other consultations but it was the recruiters’ response to them that differed. There was only one case in which the recruiter readily accepted the participant’s preference without further discussion of it, in a similar way to those in trials 1 and 2. In this case the man offered a clear rationale for his preference and this was accepted without exploration by the recruiter. In all of the other 73 cases, however, the recruiters did not readily accept the participant’s preference but explored it further.
Although the nurse recruiters had a checklist of information to cover in the recruitment appointments, the way they actually structured the consultation in response to a preference voiced early on varied. Some recruiters acknowledged the preference and then discussed the three study treatments, exploring and addressing the preference as part of this process. These consultations tended to be more structured and led predominantly by the recruiter[
17]. In other consultations, recruiters started by exploring the preference, using this to discuss the treatments in more depth, in appointments that tended to be more loosely structured and led mostly by the participant[
17].
Exploration of preferences
Three key techniques were used by recruiters in trial 3 (ProtecT) in response to participants’ treatment preferences, all of which were indicated in their training[
14]. Details of these techniques are given below. The numbers indicate the order in which techniques tended to be used, although this did vary especially in the consultations that were more loosely structured. Not all approaches were used in each consultation but at least one approach was used, and often the recruiters employed multiple approaches.
1.
Elicit and acknowledge the rationale for the preference
When participants voiced a preference for a particular treatment the most frequent response from recruiters was to establish the basis for it. Justifications for preferences were often given without direct prompting, but where they were not stated or were unclear, recruiters would seek to understand them with direct questioning, such as ‘ Is there any particular reason why you think that way is better than the other ways?’ or ‘Why do you think like that?’. Once a rationale was established, recruiters moved on to explore and discuss the underlying reasons and beliefs:
‘RESEARCH NURSE: I know that [surgery] is your least [preferred] treatment. Is it the fear of an operation, going through surgery, or are there things that you’d like to discuss that I might be able to perhaps relieve some anxieties about surgery?’
(Trial 3, study centre 9, patient chose initial preference).
This more detailed exploration of the basis of the preference revealed reasons that were multilayered and complex, usually internally rational and logical, and sometimes guided by lay perceptions of prostate cancer and the available treatments. For example, favoring radical therapy to ‘get [the cancer] all away’ or desiring conservative treatment because ‘if it’s not broke don’t fix it’. Some rationales were more emotive than scientifically based, for example, relating to the experiences of relatives who had died from cancer. These discussions provided the recruiter with useful information to tailor information provision to address patient concerns.
2.
Balance participants’ views about treatment
After ascertaining the basis for the preference, recruiters would usually acknowledge these reasons, but then indicate that they should still go through information about all treatments to ensure that participants had the necessary information to make an informed decision:
‘RESEARCH NURSE: I appreciate what you say about monitoring and if at the end of this discussion if that’s what you feel, we will support you whatever you want to do… But before you do that I need to go through your results with you because you’ve got to be entirely clear what your results mean… there are things about the treatments, that you may not have considered…in all the positive sides about the treatments you have to know what the down sides are as well..…you have to be able to know in your own heart, that you have explored every angle....whatever decision you make you know that you will have had all the information about these treatments for you to make that decision.’
(Trial 3, study centre 9, patient randomized to initially less desired option and accepts it).
Recruiters then provided information to balance participants’ views about treatments by highlighting the disadvantages of the preferred treatment and advantages of the less desired treatments, as some recruiters did in trial 2:
‘C01: I’ve achieved my aim as in I’ll still stick to the monitoring.
RESEARCH NURSE: How will you feel about the psychological effects of monitoring? Have you thought about how that will affect you mentally? The cancer’s still there, its’ not gone away, we haven’t removed it. I need to find out that part because the, all of our men who are on monitoring it’s the biggest problem.’
(Trial 3, study centre 1, patient chose initial preference).
‘RESEARCH NURSE: Now the thing with surgery is, yes it’s a potential cure, you’re quite right about that, but the problem with it is that umm it is a major procedure.’
(Trial 3, study centre 4, patient randomized to initial preference and accepts it).
They further encouraged participants to consider a balanced view of the treatments by tailoring information to their needs, for example, providing reassurance to alleviate specific concerns and correcting inaccuracies about treatment:
‘C89: There’s no way I can do that [continue with his caring commitments] after this [prostate] operation....
RESEARCH NURSE: Right well I mean we can help with that sort of thing.... we do put things in place to help the men when they’re out of hospital. So you know, don’t discount that immediately.......’
(Trial 3, study centre 3, patient randomized to initial preference and accepts it).
‘RESEARCH NURSE: So [I’ll] talk about the radiotherapy next
C19: Oh dear, this is the worst one
RESEARCH NURSE: Is it? Why- why d’ya think it’s the worst one?
C19: I- I’ve got a brother-in-law, he jus- (−) he’s had lots of trouble with his throat [had cancer of the throat]. And he- he’s lost his teeth, hearing’s gone and, err, he’s in a hell of a state......Because it don’t just [radiate] the (−) affected zone but it sort o- ‘cause the beam seems as though it sprays a bit an’ it, err, destroys everything
RESEARCH NURSE: .....Now (−) yes, there is always that chance that that can- th- that the radiotherapy is gonna hit the surrounding tissue ...... But, these symptoms tend to be worse towards the end of the treatment, ok, and then start to improve….. We want to reduce the side effects and the risks of the surrounding soft tissue, so, by doing -, you know, having the- the hormone treatment, it helps us to- to be more precise with the radiotherapy..... Now, what you’ve got to remember is, your brother-in-law has had a very different type of cancer.... your teeth are not going to fall out with this one, nor is your hair or anything like [that] and we are looking for precision.’
(Trial 3, study centre 7, patient randomized to initially less desired option and accepts it)
They also highlighted the position of clinical equipoise to counterbalance participants’ views, emphasizing that although all treatments offer equally good survival rates but with different side-effect profiles, there was a lack of evidence to support a clear choice between them:
‘C05: That’s the one, the monitoring. Mainly because I’ve only got a small, microscopic, yeah and I think it’d be best for me, uh, to have that, to come back every two or three months. And if it does get any worse, then I would gladly have the operation.
RESEARCH NURSE: Well, unfortunately, it doesn’t quite work like that..... the thing is, we don’t know the best way to treat prostate cancer and the three treatments that we have, in terms of how long men live, are all equal. So it doesn’t matter which treatment you have, men tend to live, you know, their life expectancy out. All three of them have advantages and disadvantages to them. And if we knew what was best for you, that’s what you would get. But we don’t know that.’
(Trial 3, study centre 3, patient randomized to initially less desired option and accepts it).
3.
Emphasize need for participant to consider all treatments and equipoise
Recruiters expressed empathy with the difficult situation of clinical equipoise, particularly with men who were struggling with the decision. Throughout the consultation in response to a voiced preference they emphasized the need for participants to try to keep an open mind about each of the treatments to allow them to weigh up the advantages and disadvantages and decide if they could consider being randomized or not:
‘WIFE: My son wants him to have the operation, get rid of it
C50: But as you’ve said, if it ain’t that big....
RESEARCH NURSE: We don’t know…there’s such a dilemma about the whole thing.... because they can’t answer that question which is the best .... we know that they are as good as each other the treatments and that’s the important thing. But each have advantages and disadvantages that are different from each other because they are very different treatments. And it’s just weighing up those, and then stepping back from that, so being open minded about each of the treatments is important because as I say they are very different from each other …. looking at it and saying, well will I at least consider any one of those three treatments as an option for me and then saying if that’s yes to that then let the computer pick the treatment for you, or there’s one that you really hate, let’s kind of discuss it some more or no I’d rather choose my own treatment.’
(Trial 3, study centre 1, patient randomized to initial preference and accepts it).
Recruiters checked participants’ level of equipoise with open questions such as ‘what are your feelings at the moment?’ to determine their openness to randomization. There was often evidence of the participant expressing the rationale for his preference and the recruiter offering information in response to enable them to consider a balanced view, with checking of their position in relation to equipoise and the suggestion of randomization, at various points
. This form of dialogue enabled men to reconsider their original preference and learn more about the other treatments. For some, this led to a sustained and confident treatment choice, but many shifted away from their original preference and became increasingly uncertain or equivocal[
15]. Some participants even chose a treatment that was different from their originally expressed preference[
15]. The appointment continued until the recruiter was satisfied that the participant was sufficiently equivocal and prepared to consider all the treatments to permit randomization, or was felt to be informed enough to choose a particular treatment.
Two extracts from appointments illustrate how these key techniques were used together by recruiters in the ProtecT trial in response to a voiced treatment preference. In the first extract we see the recruiter eliciting the man’s concerns with his less preferred treatment options and then providing information to put these concerns into perspective. The recruiter further encourages a balanced view of treatments by checking he is comfortable with the potential drawbacks of his preferred treatment. Likewise, in the second example the recruiter offers balanced information in response to a preference by emphasizing the advantages of the less preferred treatment, and later by emphasizing the position of clinical equipoise and uncertain prognosis following his concerns for the less preferred treatment. In both cases the recruiters ascertain the men’s position of equipoise (twice with C85) and when it is clear what the man’s position is, a treatment is either chosen (as in the first extract) as the preference has been sustained, or randomly allocated (as in the second extract) as the preference has dissipated and the man is accepting of all treatments:
C78: I’m definitely veering towards the monitoring side of things, because why have all those additional complications, the potential for them… I’ve got a good quality of life and I would like it to continue.....
RESEARCH NURSE: So what would be your worry with surgery?
C78:…With surgery there could be complications…the catheter and impotence.
RESEARCH NURSE: …It’s difficult to say…the majority of men won’t have those problems… What’s so worrying about radiotherapy?…
C78: Well it can affect other areas like the bladder.
RESEARCH NURSE: Hmm that’s usually very short term.
C78: Is it?.....
RESEARCH NURSE: Can I just ask, how do you think you would feel if you go for the monitoring, the one you’re drawn to, if your PSA was creeping up a bit cos it’s not something that you know from one blood test we can’t suddenly decide..... and I wonder how that would be you know sort of, kind of waiting, the blood test and all that?..... [Further discussion about drawbacks of PSA monitoring]
RESEARCH NURSE: So the idea of all treatments - they’re not equal to you in anyway?
C78: No…
RESEARCH NURSE: Whatever you decide, as long as you’ve had all the information.
C78: Oh I’ve got all the information.’
(Trial 3, study centre 9, patient chose initial preference).
C85: If I went in for the operation…. then you’ve got the recovery, then you’ve got this that and the other [side effects] and then I think I’m better to leave it [have active monitoring]
RESEARCH NURSE: The guarantee with that [surgery] I would say is that they would get rid of the prostate cancer ….. you get that reassurance because you know it’s gone, the cancer’s gone [Discussion continues about all treatments and the trial]
Wife: Oh as he walked through the door he was definitely [opting for] monitoring….
RESEARCH NURSE: How do you feel [now]?
C85: I don’t know, when does the decision actually have to be made? [Discussion about the trial/randomization]
C85: Doesn’t it say in that you could be cracking a walnut with a sledgehammer and you might be-
RESEARCH NURSE: Could be but we don’t know that you see…this is the thing we might need a sledgehammer we just don’t know, that’s the problem [Continue discussion about treatments and the trial/randomization]
C85:.... I didn’t know the implications, therapies…because to be honest I just put that on the back burner…. this has been very informative….
RESEARCH NURSE: So how do you feel then, what are we going to do?
C85: I’m, I’m happy with all three so to me it would seem a crying shame not to take part in this work today…well, well they’ve all got their pluses, they’ve all got their minuses…I haven’t got a preference as such you know they’re all equal. [Randomized and told allocation] To be honest I would have been ok with any.
(Trial 3, study centre 3, patient randomized to initial preference and accepts it).