Treating to target
All staff expressed ambivalence about the trial target (HbA1c ≤6.5) because it was tighter than normally aimed for in routine clinical practice and recommended in clinical guidelines. Some described feeling that "sometimes they were asking almost for people to be at too high a risk of hypoglycaemia" (RN17). Others highlighted the lack of evidence of long-term benefits of treating to a tight target: "over a 5 or 6 year period it doesn't seem to improve outcome to any great degree" (Phy3), or commented that "there is some evidence that if you do go too low, it can actually be dangerous" (Phy7). The emphasis placed upon tight blood glucose control rather than other risk factors was also questioned by some staff:
"We probably need to be much tougher on cholesterol, much tougher on blood pressure em, and just do the same as what we're doing for glycaemic control. We've allowed our thinking about this, about how glycaemic control can influence macrovascular events, and they don't really. It doesn't really shape, shape em, it's not going to, it doesn't stop people dying." (Phy5)
Staff also expressed reservations about applying a 'one size fits all' target to all patients commenting that, in clinical practice, treatments would "be individualised to each person" (Phy17). While tight targets were generally seen as appropriate and realistic when patients were relatively young, motivated/adherent and/or at risk of complications, staff described being less keen to pursue tight targets amongst the elderly, especially those who lived alone, and those who did a lot of driving or physical activity:
"A tight target is realistic for anyone who is, its difficult to have a age cut off, but um sort of under the age of 65, who is worried that high glucose levels will damage their blood vessels, and who is up for engaging in better control ... Contrast that with a very old person with lots of other problems in whom you're not going to do them any favours by tightening up their glucose levels. Because you've got to say to yourself, 'well, what are we actually going to achieve here if we make then tight and them falling, and then them being admitted with a fractured hip?'" (RN17)
"Some of them, because of their working lives, you know, they travelled a lot, or they were builders doing really physical work one day, maybe indoors and outdoors and that seemed to vary it. And if they were suddenly having lots of hypos sometimes you were better erring on the side of caution and being higher because at least that way they could still work, still function." (RN19)
As the above quotes suggest, worries "about patient safety" (Phy17) were widely discussed by such staff members. Some staff also raised concerns that increasing patients' risk of hypoglycaemia could potentially undermine trust and the long-term therapeutic relationship: "one hypo and they lose confidence in the system and it's very difficult to do anything with them." (Phy9)
Staff also highlighted the potential dangers of instilling a sense of failure in patients who had not reached the trial target but had achieved better control during 4-T. This informed the decision that some had made to not inform patients of the trial target.
Using the TMS
While generally considered a useful guide or starting point for determining patients' insulin doses, all staff, especially those who came to the trial with extensive diabetes clinical experience (see below), described regular deviations from the TMS' recommendations because, "it's for sort of for ideal patients, and not every patient is ideal" (Phy17). In most instances, deviations occurred when, based on their clinical experience, which included that of having previously used the insulins investigated during 4-T, staff considered TMS recommended doses to be too high and as putting a particular patient at risk of hypoglycaemia:
"I think it's difficult really because I've been doing it for x number of years and obviously was very comfortable with those particular insulins. And whether it be a fault of the protocol or the system or just my thinking, I don't know, but it did make you stop and think, 'well that just seems too much.'" (RN13)
In a few cases, deviations were also a direct response to patients' resistance or refusal to have their insulin doses increased after experiencing severe hypoglycaemia. Staff described how this could result in a balancing act "between keeping the patient in the study and trying to fulfil the protocol as best as you could." (RN13)
Some also conveyed concerns about the potentially flawed and 'untrustworthy' data upon which the TMS' recommendations were based. Nursing staff pointed out that the three days of SMBG data fed into the TMS could be a potentially inaccurate representation of a patient's blood glucose control over the previous months:
"But I'm looking back over quite a lot of readings, I would make my decision on that rather than just maybe the week the patient's coming in. Because you have other things, like maybe they've got a stressful week on or, you, you know, you've got the patient in front of you and you've got the diary in front of you, you would sum up and then make your decision." (RN15)
Some also speculated that SMBG data might occasionally have been fabricated by patients; typically when diaries were presented in pristine condition. It was also pointed out that the TMS did not factor in for symptomatic hypoglycaemia above the trial's SMBG 3.1 mmol/l threshold, or for experiences of 'near hypos'. Staff described how they would exercise their own judgement on such occasions, drawing upon their clinical experience:
"Because the thing is, we'd only write hypos in the system, but sometimes patients would be talking about near hypos and obviously there was no way of recording that. So with that in mind, if they said, 'oh, I always feel a touch lower before lunch' blah blah and they told you that quite a bit, there was no way to record that... And then so you'd think 'well I'm going to lower that then, that one, and then put it up a bit more later'. But the TMS didn't know that, so it would tell you different information and then you'd go "oh I'm not happy about that because I think that would drop them down too low." (RN19)
While staff perceived the TMS as a potentially useful tool for less experienced colleagues, such as those based in general practice, some nursing staff said they had disliked using it because they felt it had belittled and undermined their expertise:
"I think for any insulin start trial, you know, you can train a monkey to start insulin, but it takes somebody with more in-depth knowledge to identify where things are going wrong sometimes." (RN2)
Other staff members, however, were more positive about using this technology. They described their previous approach to managing insulin treated patients as having been overly conservative and commented that positive experiences of using the TMS had helped them overcome their resistance to intensifying insulin treatments in both the trial and in their clinical practice:
"We've always been used to rather more tentative doses to start people on. So you know, we would ordinarily have started people on 20 units a day and the slide rule said you start on 40 in the morning and 16 at night or something. Then you're going to step back a little from that and think 'hang on a minute, that seems rather a lot to me'. But once you got used to it, and learnt to trust it, then it seemed to work most of the time." (Phy14)
Negotiating the boundary between research and clinical practice
"Working as a DSN and a research nurse, that is a bit of an issue for me... I sometimes found myself in a bit of a dilemma where I think, well off trial, I wouldn't be doing this." (RN2)
As the above quote highlights, cross-cutting the staff interviews is the tension, and difficulties, encountered when the trial protocol required them to deliver patient care which differed from their routine clinical practice. While staff talked about experiencing a conflict between their roles as practitioners and researchers on such occasions, the greatest dilemmas were conveyed by RNs. While this was partly because they were responsible for delivering most direct patient care during 4-T, many RNs also came to the trial with extensive diabetes clinical experience as they had worked and/or were continuing to work part-time in a Diabetes Specialist Nurse capacity alongside 4-T (see table
1). As various staff members commented, the greater the RN's diabetes clinical experience the more likely they were to have deviated from TMS recommended insulin doses during the trial. RN6, for instance, who worked for a research company and did not have a therapeutic speciality, noted that, whilst she had "tended to just go for what was suggested on the computer", her more clinically experienced colleagues:
"were just putting in what THEY thought were the right doses and not going with the algorithm, the protocol." (RN6)
As well as deviating from the TMS' recommendations, clinically experienced RNs also offered patients extra visits and/or input (e.g. dietary advice, training in carbohydrate counting) to those outlined in the protocol, to reflect the care they would provide in their diabetes clinical practice. Some also indicated that they had given patients extra services and enhanced clinical care (such as a quick referral to a chiropody service) to foster treatment adherence and trial retention.