Several interviewees at the implementation sites remarked that the HTWT guide had been of little help in tackling the hurdles that they faced in getting approval for BLNA adoption and they did not expect it to be of much assistance elsewhere:
Well, the business case is normally written by our manager with advice from ourselves. So I provided the information from the How To Guide and the empty boxes that you have with it suggesting that they fill in the numbers around our case. But they felt that that didn’t mesh with how business cases are submitted within this trust. You couldn’t just paste the How To Guide ... And so that sort of didn’t progress.
Consultant breast surgeon, IS1
Discussing the value of the HTWT guides, the operational manager for breast care at IS1 commented:
And that’s the problem, you see. All the arguments that they give for bringing this in except, you know, the patient experience–are all the issues I have and it doesn’t tell you how to overcome those issues ... It was just a reminder. I mean, actually, most managers, if you’re used to writing cases, would be able to know how to be able to write a business case. And obviously each organisation does things differently, but it actually just reminds you of what you should be considering. But if you know your service, probably the information–It’s just a confirmation really. I didn’t find it useful. I didn’t learn anything from it because it actually didn’t give me the answers to my own problems locally. And the things that they suggested, I already knew. So it was more difficult.
Operational manager for breast care, IS1
One specific issue raised by the participants in the implementation trusts was the collection of evidence that the guide stipulated would be needed to underpin the business case. This was a problem because the data required were not routinely collected and doing so would demand a significant effort which the trusts could not resource:
[xxx] wanted some data, the breast surgeons told him they didn’t have access to it and he sent an email to me saying, surely you must be able to get this data, it’s easy and essentially it wasn’t easily because we don’t routinely keep that data. It was how many ... positive nodes wasn’t it, they wanted a number putting on that, so that would mean like reading through 300 patients.
Biomedical scientist 1, IS2
Reports for every mastectomy, wide local incision, so I said, well if you’ve got the staff, send them, come and look through them, feel free, we haven’t ... And there was a move afoot at that meeting where they want to collect as much data as they possibly could and set up centralised data collection. One trust, one site would be responsible for collating all this data.
Biomedical scientist 2, IS2
Crucially, NTAC was criticised by some participants for not having involved PCTs in the development of the BLNA guide:
And I thought right from the outset, when we put in our application, it was absolutely key to have your commissioners on board with you on the project right from the start. And I think that, again, we
were fairly unique within the group when we went–when we had our first NTAC awayday, the
others all sat up when they saw [xxx] there. They said god, why didn’t we think of having a PCT lead on our project straight away, because I mean let’s face it, they’re the people that are paying for it. So, you know, you’ve got to have them on board, engaged in what you’re trying to achieve right from BREAST LYMPH NODE ASSAY CASE STUDY
Overall, participants acknowledged that being involved in the BLNA project had brought advantages. It had created the opportunity to work with staff from different trusts, had enabled comparing of practices and exchange of ideas about solutions to problems:
I think the premise of NTAC is very good for getting different areas within a trust, the clinicians, pathologists, pathology staff together whereas otherwise they might have never of had a meeting, oh no I can’t do that, you know how these things work but because they were being pushed into it externally it’s more likely to actually happen and then also you’d got those groups of people that were then forced into meeting and working together within the trust, being forced into meeting and working with similar groups of people from other trusts as well.
Biomedical scientist 2, IS2
However, there was scepticism that this mutual learning would have any transferable value for trusts in dealing with what many perceived as the major stumbling block for BLNA adoption–the lengthy and difficult negotiation process between trust and PCT:
I think the aim if I’ve understood it correctly was that by the four pilot sites doing what they did they would end up assessing a new technology which for anybody else that wanted to take it up and run with it all they had to do is to pick this up, take it along, get it agreed and you could roll the
technology out very quickly; and I agree that that is a laudable aim ... I just don’t see having been through the process on several occasions you know with business cases, it always seems to come down to those local negotiations that are going to go on between the PCT and the trust and that in reality is what’s taken the time to get sorted out.
Directorate manager of pathology, IS2
I think we could have achieved what we needed to achieve anyway. What did come out of it from NTAC was hopefully a guide to others as to what they were going to have to go through which I think will be a useful guide but I’m not sure that that is going to stop the same problems that we’ve
experienced because you’re still going to end up with the same negotiations, the same discussions with a different set of PCTs ... it isn’t going to stop the interactions that have to be gone through with the PCTs and the organisation.
Directorate manager of pathology, IS2
With respect to the HTWT guide specifically, concerns were expressed that the low level of awareness of NTAC and its activities would blunt its value:
I don’t think a lot of people have heard of NTAC. People have enquired about the assay, I’ve pointed out the guide, and it doesn’t seem to be that anyone’s heard of it or known they can access it, so there’s definitely a problem it’s all been very worthy stuff ... and then hardly anyone in the NHS even seems to know it exists. They need to get a higher profile really.
Biomedical scientist, histology, MS
Discussion and summary
The adoption of BLNA was arguably the most complex of the three case studies we undertook and this clearly impacted on the speed with which the implementing trusts were able to complete their projects and, because adoption was contingent on local factors, it also impacted on thewayin which they went about it. Yet, at the start, the prospects must have seemed good, the basic case for adoption was strong and, when looked at from the perspective of the NHS as a whole, unambiguous and adoption was consistent with NICE guidelines for breast care. As we also saw from the interviews, clinicians were unanimous about the patient benefit and their role as organisational champions clearly made a difference.72However, staff who had direct contact with patients (i.e. breast care nurses) were not so
confident that patients would be able to grasp this when they were already likely to be experiencing anxiety and pressure.
The complexity of the BLNA case study arises from a number of organisational factors78that came into play
at the trust level (i.e. financial implications and risks;58adaptation of clinical workflow and reconfiguration
of surgical and non-surgical work practices,73,119,121some of which required negotiation across professional
groups;64and technological uncertainty). Of course, it is these trust-level challenges that HTWT guides are
designed to tackle, but the effort of translating a generic template for innovation so that local factors could be taken into account was time-consuming. Making a case for adoption demanded significant effort if trust management–and other stakeholders–were to be convinced that this could be done within acceptable levels of risk–financially and operationally. Trust management also had to weigh up the relative benefits of different service development options and possibly prioritise them.
From a financial perspective, PbR meant that trusts might not themselves experience the benefits identified by NTAC, at least in the short term. To add to the challenge of making a business case, there would also be costs of equipment and staff training. To help with the presentation of the business case, HTWT guides include a business model template that set out in a standardised, tabular format the key elements to be addressed. Reflecting the complexity of the BLNA business case, its HTWT guide also included a costing model to help trusts estimate the financial implications of implementation. We found no evidence, however, that it was used by the trusts participating in the BLNA project.
At the clinical pathway level, reorganisation of theatre lists was necessary as the intraoperative testing has the potential to cause both under-runs and over-runs of theatre lists. How this reorganisation would be done would vary from trust to trust. In addition, for some trusts, these changes could result in additional costs, for example the recruitment of new staff or the provision of laboratory space close to the theatre. Service level adaptation was required not only for breast cancer surgery itself, but also for outpatients, follow-up clinics, bed use on main wards and other services which shared the same facilities.
A key area of non-surgical work practice reconfiguration was in pathology. The need to train pathology staff in the skills required to perform the assay was relatively easily satisfied. Trusts found it less easy, however, to meet a core requirement–rapid testing and reporting back of results. Ideally, the assay would be done in theatre, in an adjoining room or, at least, in the same building. However, not all of the
trusts could satisfy this requirement without making significant changes to pathology work practices (e.g. creating a new‘satellite’pathology laboratory next door to theatre; using‘runners’to take the biopsy to the pathology laboratory and return with the results, which added to costs of implementation).
Moreover, as a histopathologist would now have to be‘on-call’whenever a breast cancer surgery list was scheduled, there were concerns that pathology staff would be unable to carry out their other duties at these times. Pathology staff themselves expressed reservations about the impact of time pressures and, in some cases, isolation from other laboratory members on the reliability of results. The workplace studies research literature on the importance of colocation for informal collaboration and the role of the latter in the routine achievement of dependable work in medical and other work settings (see, for example, Luffet al.208and Buscheret al.209) substantiates their concerns about the risks involved.
Finally, the BLNA project was affected by uncertainty around the supply of the technology. When the project started, supply of the technology appeared secure, hence NTAC would have had no reason to see this as a risk factor. By the time one of the suppliers withdrew, the project was well advanced and the trusts were able to adapt. However, this contributed to delays in implementation as the pathology labs re-evaluated their options.
In summary, the barriers faced by the trusts participating in the BLNA project can be attributed to a range of factors: funding issues (i.e. financial reimbursement mechanisms, paying for additional pathology and
theatres); user training and acquisition of new skills (i.e. for pathology staff); and uncertainties about the availability of the technology itself. In ANT terms, they can be understood as outcomes of complex interactions between heterogeneous networks of human and non-human‘actors’.84,88,89In the BLNA case
study, we can identify two key groups of human actors: trust staff (clinicians, pathologists, nurses, business managers) whose alignment is needed to adopt the innovation, and PCT commissioners, with whom the trust must negotiate how the adoption of BLNA will be paid for. For BLNA, the evidence base furnished by NTAC was effective in achievingproblematisation, the first stage of‘translation’, but subsequent stages of
interessementandenrolmentproved more difficult and contingent on local factors, so that each trust came up with its own solution. First, supporters had to negotiate the prioritising of competing business cases. Second, uncertainties over the availability of the technology had to be resolved and changes in working practices demanded by its adoption agreed upon.
Financial risks mean that business managers might not be convinced that adopting BLNA was in the trust’s best interests. However, as we saw in the case of the mentor trust, where a trust has a strong research culture and reputation to maintain, other factors come into play and tip the balance in favour of adoption.49However, there was concern that this research culture was under threat from increasing
bureaucracy. Of course, without some trusts being in a position to offer mentoring in innovation, the NTAC model cannot work.
For the participating trusts, the BLNA project had had real benefits. Attending the awaydays enabled staff members to compare practices, to extend their professional networks and to engage in‘social learning’.73
However, what was unclear was whether or not there had been useful learning that could be‘packaged up’in the HTWT guide for reuse by others in the future, that is to enable other trusts to overcome the barriers and follow the translation process more easily through to successful completion.45In other words,
the HTWT guide was seen as providing a template for innovation at only the most generic level. In ANT terms, the guide was a useful tool forproblematisation, but of more limited value forinteressement, enrolmentandmobilisation. In the absence of a central push for innovation that would drive this translation process, its value would inevitably be limited. No information is available to us about the subsequent use of the guide by other trusts.
Even if there were a stronger push on trusts from the centre to innovate in the NHS, the BLNA study demonstrates that financial instruments such as PbR would still be a major impediment to securing the interest of all key actors and persuading them to co-operate.19,52The impact of PbR makes itself felt when
the costs of innovation cannot be contained within the boundaries of the health-care provider (trust) or commissioner (PCT) and a national tariff for the innovation does not yet exist. In the absence of a national tariff, adoption of an innovation such as BLNA by the NHS will depend on local factors, in particular a willingness on the part of service commissioners to find an equitable solution to sharing the costs and benefits. However, when this does not happen, for an innovation like BLNA, it creates a major obstacle to the achievement ofmobilisation, the final stage of translation and its adoption across the NHS.
Chapter 8
Discussion and conclusions
I
n this chapter we first return to our research questions, using these as subheadings to organise discussion of our findings across the UFRI, IPT and BLNA case studies. We next consider our findings in relation to our aims and objectives. To begin this discussion,Table 6summarises the main characteristics of the three clinical technologies under discussion.Of the research questions, four are specific to NTAC. We considered NTAC’s role inChapter 4. In this discussion we further consider its function in relation to the three cases. We consider the final question about best practice for technology adoption in our concluding comments.