Clinicians’ views on the upper reference ranges and predicted prostate-specific antigen for men without prostate cancer

Clinicians expressed mixed views about the value of having data relating to men without PCa presented in the AMS. Two out of 18 clinicians/nurses could not see the relevance of these data for a system targeted at men diagnosed with PCa:

But if you know they’ve got prostate cancer I don’t think you need to know what the normal range would be.

U15

Others tended to take a broader view of how the data for men without PCa could be used in practice, particularly in the earlier stages of AS for newly diagnosed men. All of these clinicians viewed the predicted PSA and upper reference range for men without PCa as having the potential to reassure patients but felt that these data were of little relevance to their own decision-making.

Clinicians’ views on showing the predicted prostate-specific antigen for man with prostate cancer

The ‘predicted PSA for a man with PCa’ (green) line was often the sole focus of the AMS for clinicians who ignored the data for men without PCa, seeing the latter as irrelevant:

The green line would be the key one, because you’re talking about men with prostate cancer.

U6

Most clinicians’ ideas on how the AMS could be used in practice were voiced with reference to the green line.

Relationship between lines: reassuring patients that they have ‘low-risk’ cancer

Clinicians felt that the AMS could be used to reassure men on AS by focusing on the relationship between lines. In particular, clinicians talked about demonstrating how close the ‘predicted PSA for a man with PCa’ (green) line was to the ‘predicted PSA for a man without PCa’ (blue) line, thereby demonstrating the relatively low-risk nature of a Gleason score of 6 cancer (see Figure 9). In other words, the AMS allowed for a visual ‘normalisation’ of a Gleason score of 6 disease:

And what that says more than anything else, that is saying that the insurance companies are right, Gleason 6 is not a proper prostate cancer, or rather, let me rephrase that, low-volume Gleason 6 isn’t proper cancer, it is a condition that changes what the man in the street regards as cancer in a percentage of people. You know it’s a pre-cancerous state or something or it’s, you know it’s not, cancer to the man on the street is something that will spread to the rest of his body and kill him. Low-volume low-rate prostate cancer rarely ever spreads and rarely ever kills anybody – and that backs it up.

U1

Four other clinicians gave similar views on how information about average PSA levels for men without PCa could be used to reinforce the idea that AS is the correct management route for men with low-risk PCa. It was noted that all clinicians who held this view were from one site, described by clinicians themselves as being particularly positive about AS:

Well I think what it confirms is actually that the men with prostate cancer – the green line [showing predicted PSA for a man with PCa] – is very close to the men without prostate cancer and therefore hence why they’re the ones we probably don’t really need to be worrying about too much as long as we just keep a close eye on them and maybe with the benefit of time we’ll realise that we don’t need to worry about them at all.

U4

Two of the five clinicians felt that the ‘upper reference range for men without PCa’ (orange) line was potentially reassuring for patients with low-risk cancer, simply because it could help to put their PSA into context. Clinicians expected patients to react positively to the idea that their values are still below a line associated with men without PCa:

In some ways that might be more reassuring for patients because you’re saying actually you can have your PSA this high even if you don’t have cancer, so and when patients only really think about PSA because they’re not thinking about the biopsies and what we find when we examine them, they’re worried about their blood tests, that orange line might actually be reassuring for patients to show them.

U4

Clinicians only interested in actual prostate-specific antigen line

Two clinicians could not see any benefits to having reference lines displaying average PSAs, explaining how the individual patient’s data are all that one would be interested in analysing. This idea went hand in hand with the view that each patient’s trends and rates of change, rather than absolute values, would be the underlying factor informing decision-making:

U2:

Yeah, and again the (reference) lines here are helpful in terms of saying to the patient where he lies as sort of an average patient. But as I said to you the difficulty with these is that there is not a direct correlation always and these are individual patients.

INT:

Yeah, of course.

U2:

So it’s helpful yes but you’ve got to qualify what you see on the screen with each patient individually.

One notable observation about clinicians’ reactions to the AMS-based vignettes was the frequent tendency to focus on the hypothetical man’s actual PSA values, without consideration to the reference lines. Clinicians sometimes needed prompting to focus on what value the reference lines added, rather than the intrinsic merits of having a graphical representation of PSA values generally:

INT:

Would you find the cancer line helpful, do you think, so the men with prostate cancer and how their PSAs tend to change?

SPN1:

Well I think a graph, plotted on a graph like that is better than looking at one on a table.

Importantly, most clinicians reported occasionally presenting PSA trends graphically in their standard practices. Consequently, although graphical presentation of PSA values was not standard practice for all clinicians all the time, it would not have been novel.

The active monitoring system as a whole: potential to influence clinicians’ decision-making?

The AMS was generally thought to be unlikely to influence clinicians’ practices or decision-making (with one single exception, presented above). Some clinicians were explicit about this but tended to qualify this view by talking about how the AMS could be helpful from a patient’s point of view:

Probably and I think, my personal view is that it would be more useful for patients than it would be for me and I think it would help a discussion about what we would expect the changes in the PSA to be.

U3

Clinicians’ main reasoning for expressing reluctance about the potential of the AMS to influence their decision-making related to their uncertainty surrounding the role of PSA measurements in predicting PCa behaviour. These contextual issues, relating to lack of evidence as to how reference ranges related to long-term clinical outcomes, were thus perceived to be the main limiting factors of the AMS:

We don’t yet have good PSA data to show that it’s a useful thing, so we’re just making it up at the moment. And anything we can do to help improve that would be useful, which is why I tend to follow a rebiopsy rate anyway pretty much whatever the PSAs do.

U9

So, that might be helpful if you saw Mr Smith going along parallel with it, as a reassurance. Yeh, but, my own practice, mirroring that of the big experts, is to do a repeat biopsy occasionally, to avoid criticism as well as to help with evaluation.

U11

Clinicians’ views on the AMS were gauged by asking whether or not they would want to incorporate it into their practice. Although responses were generally positive, the way in which this was conveyed suggested the benefits of doing so would be limited. One pattern to emerge was clinicians’ suggestions that they had nothing to lose by having access to the reference ranges, thus framing this as an additional piece of information that could be of interest. There was a sense that having the AMS would ‘not hurt’, but its value had yet to be proven:

No I like this, this one, it’s nice. I, I think . . . I don’t think . . . if I had it, it’d be nice. But if I don’t have it, it’s still OK.

U7

Men’s engagement with the active monitoring system

Four of the 20 men did not engage with the AMS at any level. These men tended to change the topic of discussion when asked for their thoughts on the AMS or produced closed responses. Further probing tended to result in comments about men being solely interested in what their clinician thought, and/or a disinterest in viewing statistics:

If you’re shown the graph, and it, the doctor showed me this graph and said, ‘This is you.’ You’re going to say, ‘Should I be worried or have you got everything under control?’

P3

The above group of men formed a minority. Most men become absorbed into the AMS following explanation of what the lines represented. Five men found these data to be irrelevant to the way they thought about their condition and the care they received. These men understood what the AMS was showing but were solely interested in how their particular PSA values were behaving:

I mean effectively what this tries to bring is some sort of norm, isn’t it. But for me it’s still kind of at a personal level. I [. . .] It’s almost like it’s saying, ok, this is this, but the average Joe is this [. . .] I would probably base it on just on my own experiences of having the condition, I suppose, and what’s happening with me. I think that would be more relevant than necessarily looking at what’s happening on a graph to other people.

P15

The remaining 11 men saw some value in viewing their results in relation to the reference lines. Men valued the additional information the AMS provided and welcomed the possibility of viewing their own PSA results in context. For most men, this was purely an intellectual interest, but it still had potential to reassure.

Importantly, men found it difficult to be specific about how the AMS could be practically used but generally reported that they would not use the tool to make any decisions about their condition and its management. These views were congruent with their tendencies to defer decision-making to the clinician in their current AS follow-up (a key finding reported in Chapter 6). These views were more of a reflection of men’s existing approaches to decision-making rather than a criticism of the AMS. There were, nonetheless, some elements of the AMS that attracted men’s attention and promoted discussion. The data below are based largely on individual comments rather than on repeating themes.

Men’s views on the upper reference ranges and predicted prostate-specific antigen for men without cancer (orange and blue lines, respectively)

A few men felt that the ‘predicted PSA for a man without PCa’ (blue) line had potential to be reassuring if a man’s values ran close to this reference point:

I think, I think if I’d [. . .] ever been too concerned about it all, then I would’ve been far less concerned if I’d thought ‘yeah well this isn’t actually out of the ordinary.’

P10 (in relation to AMS presentation of Mr Smith’s vignette where man’s PSA values run just above the blue line)

The orange line was seen as potentially reassuring or alarming, depending on if figures fell below or above the line:

Well I think it’s very interesting, the 95th percentile line. Which shows, you know . . . that, in a way it’s a reassurance, isn’t it?

P4 (in relation to AMS presentation of Mr Smith’s vignette where man’s PSA values fall below the orange line)

P4 [in relation to AMS presentation of ‘Mr Jones’ vignette where men’s PSA values exceed the orange line]:

Well, the fact that I was exceeding, you know, 95, you know – there’s only, we’re in this very tiny 5% aren’t we?

INT:

Yeah. I see. So the fact that it peaks above it?

P4:

So if I’m above there, oh heck, I really am in trouble.

The fact that the orange line was visually the highest reference point may have played a part in shaping men’s reactions:

And (he’s) nowhere near this threatening sort of red line [reference to the orange line] that, you know, you could get up to.

P7

One man suggested that the mere spatial arrangement of lines would be sufficient to influence his interpretations of plotted PSA values. The fact that the orange line simply existed as the highest reference point ran the danger of making men complacent as long as they fell below this:

I’m not quite sure about this 95 line, whether that’s helpful or not. [. . .] Because there’s a danger that it distorts your thinking. Because you think ‘Oh I’m a way off a risk, high risk level’, when that might not be true. I don’t know.

P14

One man considered the value of the orange line in relation to the blue line. The message that PSA values in men without PCa were so wide-ranging was deemed reassuring, as it further reinforced the man’s pre-existing ideas about the limitations of PSA values when it came to monitoring cancer severity or progression. This man was keen to minimise the ‘life intrusion’ of routine PSA readings; this additional knowledge seemed to justify this stance:

Oo gosh. That’s a really good one. I think – well it’s made me think that actually made me even less anxious about PSA than I was. Which wasn’t terribly . . . because it’s more kind of random than I thought, in a way. Not random – that’s the wrong word. More variable than I thought.

P13

Finally, similar to views expressed by clinicians, one man commented that the data on predicted PSA values for men without PCa (blue line) were irrelevant to men who were aware of their diagnosis:

Umm, I don’t think that adds much [. . .]. Because, obviously, you would think that if you haven’t got the cancer your PSA would be lower. Wouldn’t it? So it shows it would be lower. So it’s telling you what you know.

P12

Men’s perspectives on the predicted prostate-specific antigen for a man with PCa (green line)

Similar to clinicians, the ‘predicted PSA for a man with PCa’ (green) line was the key reference point most men focused on, mainly because this was perceived to be the most relevant to them, given their condition. A recurring theme, discussed by seven men, was the reassurance associated with following the green line. This reassurance stemmed from the idea that their PSA values were not ‘out of the ordinary’ relative to other men in a similar position, thus giving them an opportunity to feel ‘normal’:

P7:

You see I’d find that one [green line] the most reassuring of the three.

INT:

What makes it reassuring on that one?

P7:

Because you’re not far off the average. You know, you’ve got cancer. And you can’t get away from that. Therefore you’re looking at that green line. And you as an individual are pretty well normal – if there is such a thing in that circumstance.

There was also a tendency for men to view the green line as an expected or anticipated trajectory, in a similar way to which some clinicians perceived this line. Following the green line was reassuring in that it gave a sense that a man’s disease was behaving predictably:

Yes, well, I think seeing that I’d be less concerned. Because, you know, that’s, we’re on the expected trajectory.

P4

Shows you the normal, standard, and you can see whether or not you are more or less following the same pattern. On the one you’re showing, there, that chap is almost exactly following the standard anticipated, and he’s still way below a level where it can be people without prostate cancer. I would say that would be reassuring, if that was myself.

P6 (in relation to paper presentation of Mr Smith vignette)

One divergent case emerged in relation to men’s thoughts on using the green line as a reference point. The individual below did not find the prospect of being a ‘typical cancer patient’ reassuring, possibly owing to a desire to distance himself from this label; he reported that he would need to fall below the predicted PSA for men with PCa to feel reassured:

P14:

Because that’s the line of the average cancer person, you think: ‘That looks worrying that I’m on the line, you know,’ [laughing] ‘I’m a typical cancer sufferer.’ So I would worry. Yes.

INT:

OK. So following the green line you would associate with concern?

P14:

Er yes. I mean that may be totally unscientific but . . .

Could the active monitoring system shape men’s decision-making?

Only one of the 20 men interviewed felt that the AMS could influence his decision-making about his treatment. This man (P6) was unique in having taken control of decision-making throughout his AS experience, from the initial decision to opt for AS through to making the decision to refuse scheduled rebiopsies. This man was thus considered to be distinct relative to other interview participants.

The principal reason underlying most men’s reactions to the AMS as a personal decision-making tool related to the attitudes uncovered throughout this chapter. Most men placed complete trust in clinicians to dictate their follow-up protocol, interpret their PSA findings and make decisions about when it was appropriate to consider radical treatment.

Men provided justification for why they felt that the AMS was of limited practical use to them, with responses falling under three categories: (1) difficulties with interpreting the AMS; (2) trust in clinicians’ abilities to make the best possible decision for men; and (3) acknowledgement that decisions would not be made on the basis of PSA alone.

Men’s views on potential uses for the active monitoring system

In general, men saw some value in the tool, even if this was simply to provide additional information. A number of men suggested more specific ways in which the tool could be usefully incorporated into a consultation, mainly for purposes of reassurance or explanation. Similar to clinicians’ views presented earlier, one of these suggestions related to the early stages of joining an AS programme. In the example below, the man felt that there was value in using the AMS to explain that PSA rises in men with and without PCa:

It might have been just useful just on the first consultation. Just to see that there are, you know, this does happen [. . .], it goes up with men in that sort of rate anyway, and what we might be looking for is inconsistency or a steady climb or whatever to worry about. But they kind of explain that, but without the graph. You know the graph just might help them to help them to show it a little bit easier.

P9

Two men suggested that the AMS could be used as a visual aid to support the clinician’s recommendation. In the example below, P12 emphasises the importance of the clinician retaining the decision-making power. He goes on to explain how the tool could justify the clinician’s judgement:

P12:

I know doctors will make mistakes – they are human beings. But I think I prefer a human being judgement [.] than a hard and fast rule that a doctor feels he has to apply because otherwise he’s going to be sued sort of thing, you know? So I would say there is a risk in being too hard and fast with your decision tool. But it’s, I mean, it is useful. I find as a man, the way I think, that’s quite helpful. But I would not like it to be the last. . .

INT:

Yes. I understand. Just to really pin down your views a little bit more, how do you think it could help you?

P12:

I think it helps me to see the trend. This visible trend. It helps me to see where I am in relation to the average, and I think it would help me to come to terms with a decision. If, for example, the doctor said well, ‘now, you see this is, you’re obviously in a bad state.’ Receiving that information might be easier when you can see that.