Read the transcript of this discussion below featuring Dr Fiona Walter [FW] and Dr Richard Roope [RR].
>>[FW] GP views on implementing the Cytosponge test in primary care. This is a discussion between two GPs. We're going to start by introducing ourselves. Over to you, Richard.
>> [RR] Hi, I'm Richard Roope, and for six years I was the Royal College of GPs national clinical champion for cancer and I'm now one of their clinical advisors are also work for CRUK [Cancer Research UK] as their lead GP.
>>[FW] Great. I'm Fiona Walter, I'm a GP by training and for the last ten years or more, I've been leading the primary care cancer research group in Cambridge in the department of public health and primary care and I have been working with Rebecca Fitzgerald and her team on this body of work that's led to the Cytosponge for most of that time for about ten years now. So this afternoon we're going to start with short presentation and then use some of the findings to go into a discussion between the two of us. So I'm going to start with the presentation and this is around clinician views on the acceptability of the Cytosponge test for Barrett's Oesophagus and this was a qualitative study that was embedded in the primary care randomised controlled trial. So just a little bit of background to start with, for those of you who are less familiar with the trial and the results, heartburn a common symptom for patients to present to us GPs in primary care. It affects about 20% of the adult population and a small proportion of these individuals go on to develop oesophageal adenocarcinoma and this has a dreadful outlook. Less than 20% of patients survive more than five years. and only 30% have been diagnosed with early stage disease, which enables treatment with curative intent. But there is a precursor lesion known as Barrett's Oesophagus. It's often asymptomatic and it's under-diagnosed. But gastro oesophageal reflux disease, (what we know as GERD or GORD [gastro oesophageal reflux disease]) is the strongest risk factor. About one in 20 people with reflux symptoms have Barrett's Oesophagus. So over the past decade, Rebecca Fitzgerald and her team in Cambridge and I've been somewhat included in this body of work, have developed evidence to show that a pill on a string, the Cytosponge, which dissolves after swallowing and can then be pulled back up Impregnated with a biomarker called TFF3 can contribute to detecting oesophageal cancer earlier by testing for Barrett's Oesophagus in primary care. So this is the front page of the paper which was published in The Lancet in August last year. It gives the results of a large multicenter pragmatic randomised control trial, but importantly for us, this was set in primary care. It was a huge trial. Actually, over 13,000 patients were recruited from a 109 practises across England and this was over a two-year period. About 40% patients in the intervention arm expressed an interest in taking part and these are all patients who were aged 50 and over and who'd received at least six months of an antacid, acid supressant medication in the previous year and had no record of endoscopy for the last five years. So about 25% of these people who had expressed an interest attended for the Cytosponge test and in the end, there were a 140 Barrett's Oesophagus diagnosed in the intervention arm compared with just 13 in the usual care arm. Meaning that there was a ratio of about 10 times as many in the intervention arm. So that's an important finding. And there have been subsequent papers and analysis of data that we will also collected around cost-effectiveness and around acceptability to patients. But today I just want to share some very top-level findings from an analysis looking at acceptability by clinicians who are involved in these practises. So before I do that, I think it's important to say, have a brief mention about the adverse effects. That very few adverse effects when noticed during the trial. Under 10% of people reported mild side effects such as a sore throat requiring some treatment, and less than 1% had anything more serious than that. Of which the most serious was a lost sponge which needed to be retrieved at endoscopy. So how can this Cytosponge fit into clinical practise in primary care? I think these results have shown is that it's very likely to be feasible during a primary care consultation. It's likely to be acceptable to patients. The current NICE [National Institute of Clinical Excellence] guidance that we have, on management and treatment of GORD is for symptomatic treatment and therefore, Cytosponge can be a very useful tool for patients with new onset symptoms who were aged, currently the recommendation is for over 55, although the trial recruited people over 50, and who don't have the alarm symptoms of dysphagia, which the guidance says that we GPs, need to make an urgent 2-week wait referral. I must add that actually at the moment there's no evidence yet for the effect of using Cytosponge on stage at diagnosis. So we undertook a qualitative study to explore clinician of acceptability. We interviewed GPs and nurses during the trial and we ask them about their experiences and views about the test and about steps towards implementation. We recorded and transcribed verbatim all the interviews, and we did a thematic analysis underpinned by the theoretical framework of acceptability. So for those of you who aren't familiar with it is, it's a little bit complex to look at. But you'll see that there's basically seven criteria which give a multifaceted examination of the extent to which people delivering, receiving health care of an intervention, consider it to be appropriate and to be based on cognitive and emotional responses to the intervention. Very happy to give more advice to people who are interested in finding out more about this framework. So the sample that we recruited were 15 GPs and 50 nurses and you'll see that the mean age was between 49, 47 so about the same with both groups. Fairly even numbers of men and women in the GPs, the nurse group was all female. The groups as a whole had quite a lot of years of experience between them all. So I'm just going to give you some top level results and can I just say at this point? It is as yet [at time of recording] unpublished data so please don't quote them. So when we asked the GPs about what they thought about Cytosponge, they were really very supportive, saying they liked the way it was so easy to use although they hadn't actually been doing the tests themselves. These had been entirely done by either practise nurses or clinical research nurses. They gauged the acceptability of this by the patients they talked to having had the Cytosponge test, and they were very gratified to hear that most patients seemed to be willing to repeat the test and they thought, as in the second quote that spoke volumes really. They also very much valued the fact that care could be given nearer to home and that using the Cytosponge stopped an unnecessary amount of patients having to go to secondary care for that test. The nurses is also really liked the fact that this Cytosponge can be delivered close to home but they had more anxiety about burden for patients. Some of them said that patients had been pretty anxious when they appeared for the Cytosponge test because it was a relatively unknown. They hadn't been able to us friends, relatives about it, and a few of their patients that had difficulty swallowing and there's this quote about the fact that the Cytosponge needs the string bunched and put in the back of the throat. Sometimes this is little difficult to get done. So then turning to clinical need and safety, both GPs and nurses talked extensively about the value of the Cytosponge once effectiveness and cost effectiveness had been established for patients presenting, particularly new onset, heartburn. Some of the nurses were more concerned about safety, about the safety of using the, Cytosponge itself in primary care setting, and also the safety of the patient both in terms of not getting too anxious before they had it and being safely returned to home to recover after having had this test done. So we've been drawing together some of these findings into some key areas which really relate to future implementation of Cytosponge into routine clinical care. These partly are around these safety concerns that I've already mentioned. I'm just going to read you a few quotes just to give you an example for each of these headings. So one GP said "People won't like the idea of it. People don't do cervical cancer screening or mammograms as much as others. The turnout rate, for instance, for FIT [fecal immunochemical test] testing for the bowel cancer screening is quite poor. So any about 60%." And actually this GP thought that's a much easier test to do than to swallow capsule. So that's something I want to discuss with Richard in a minute. That really covers the point about engagement with patients as well as tests in the community. There was a great deal of concern, particularly from the GPs, about the costs of delivering the test in primary care. Not just the actual monetary cost, but also the cost in terms of time and capacity and burden on primary care. One of the interviewees said, "In primary care we're facing an increase in workload that's come out of hospitals so the capacity is maxed out. If we were to take on something like this in primary care, we'd need to know where the staff are coming from to do it and if we're then responsible for employing the staff, and then where's the funding coming from?" Both doctors and nurses talked a great deal about the fact that implementing might be much easier if we were to organise primary care to delivering special clinics and teamwork and so an example of that is someone saying, "You'd need someone doing it regularly, I think in a clinic setting, which would get over some of the logistic issues. We're working to scale and we're working networks and alliances so I don't foresee there's a huge problem but I don't see it happening in the middle of a Monday morning surgery, you know, that's not going to be feasible. It would have to be booked on a book clinic, perhaps booked online, and then yes, I think it would be a practise nurse delivering it sort of thing." And then the final area that people talked a great deal about was how primary care could maintain, not only get trained in undertaking the Cytosponge test, but also how to maintain competency and run the sorts of processes that were necessary. So my final quote is from an interviewee he said, "It might be much more suitable to deliver in hubs than an individual practises because you need a degree of specialisation in this sort of thing. I know our nurse who who did it. They said they were on a learning curve, they were quite proficient by the time they came. But it's taken a while to get used to the procedure and in fact, they described it took up to about 10 procedures before they felt absolutely confident. So there will be an issue for nurses in terms of how they'll maintain that level of skill." So that's enough quotes for now. Before we on I'd just like to acknowledge the team who to took part in this study and particularly the primary care practises and the patients who contributed to such a huge trial. So over to Richard, here are these areas for discussion. And I might turn off the slides now, stop sharing and come back to, to talk between us about some of these issues. If we work down these list this list, Richard, I'll start with asking you about some of these safety concerns that we heard both the nurses and the doctors talking about.
>> [RR] Yeah, I guess there are those safety concerns, So is the procedure itself safe? The other thing that I think it would be quite good to unpack are things like the indemnity, so you say if you've got a negative test and subsequently problems happen down the line, is that going to be an issue?
>> [FW] So in terms of indemnity, what do you think both GPs and nurses would need to work out to implement this? Would it be a practice indemnity, for instance, or would it be personal indemnity as well? What sort of procedures would we need to get lined up for implementation?
>> [RR] I think we would just have to have that reassurance that actually if you have a negative test, unless there is a change in the clinical scenario that actually we're not obligated to go and do a gastroscopy.
>>[FW] Yeah. So I've been talking to some community members who talked about would they, for instance, have open access? If they had been buying over-the-counter antacids and they heard that a local practise was delivering the test, might they be able to just make their own appointment even if they weren't a member of the practise, what might the applications be of asking for that? How close do you think we are to those sorts of approaches being available in primary care?
>>[RR] Yeah, I think it's quite interesting, so there are some trials going on, for instance, with breast referrals that ladies, who find a lump in their breast whether they can essentially self-refer. So I think we are maybe on the cusp of things being done slightly differently, where the GP doesn't necessarily have to be at the hub of the wheel for all clinical scenarios. So actually I think there may be a loosening in the months and years ahead where patients are able to access investigations and diagnostics. So that is a distinct possibility. I guess this might be one such area where if someone is repeatedly going to the pharmacy and getting their antacids like Gaviscon, or whatever, if the pharmacist is alerted to it, they could then say, "Well, have you considered actually having one of these tests which is available at your local clinic or whatever?"
>> [FW] Or even at the pharmacy.
>> [RR] Or even the pharmacy, Absolutely. And I think as we move towards the more collaborative working which, we're seeing with the PCN [primary care networks] formation, and one of the things that I think it's quite exciting that maybe one of the offshoots of the COVID season is it has forced us to work more collaboratively and think of being more together with our neighbouring practises. And as we heard in your presentation, the numbers are such that you probably need one or two skilled nurses, trained nurses who could provide a service for maybe three or four practises so that they are skilled at doing the procedure and the voice that is needed to take a patient through the investigation?
>> [FW] Absolutely. And then I mean, you a little while ago mentioned about liability. There is that whole area, isn't there, of how do we get results back to GPs, who ultimately would bear the responsibility of referral if someone was found to have a positive Cytosponge test.
>> [RR] Yeah. Although I guess you could put in place the structure that you're getting in some of the referral pathways where you go straight to test, then an abnormal result could be routed directly through to the local gastroenterology departments so that they could reach out the patient directly. So, one could design a pathway where that burden of clinical responsibility could actually be channelled in a different way and probably a more appropriate way.
>>[FW] Yeah, That's great. Okay. Let's move on to some of these quotes we had about concerns about patient engagement, particularly when this was about a potential investigate test for cancer. So of course, it isn't. We know that the Cytosponges is about detecting Barrett's Oesophagus and that this is just a risk factor, albeit probably the most significant risk factor for oesophageal cancer. But we had one of those GPs then talking about, well you know, people don't really like doing the FIT test and that's just dipping something in their poo. How would we engage, do you think, better with people when this is, though it's not like having an endoscopy, it is still actually swallowing a sponge and having that removed again.
>> [RR] I guess it's if the patient is getting to the stage where they might be being considered for an investigation anyway. If the choice was the Cytosponge, swallowing a capsule in familiar surroundings with nurses you might know, or going into your local hospital for an endoscopy actually one against the other I think our might side with the Cytosponge. Not having ever had a gastrostomy personally, but I'm not sure it's something I'd be queuing up for. Whereas the Cytosponge I think sounds as though it's probably more acceptable even, than a gastroscopy.
>>[FW] Yeah. We also know that a lot of patients are very concerned about stepping foot in hospital during the pandemic, and indeed, even stepping foot in primary care right now, even though we're trying to give out the messages that primary care is open for everyone, has been and will be. Do you think this has got any impact on potential implementation of the Cytosponge?
>>[RR] Yeah, I think we are getting used to the idea of having things being delivered more locally. As we move to the possibility of community diagnostic centres is being raised at the moment. I'm working alongside the rapid diagnostic centres. So I think we are looking again, we are at the beginning of a change of how we do things. And it's amazing how the wheel comes around and how those of us who are slightly thinner thatched and long of tooth that actually we're familiar with having local investigations and then they were all centralised over the last 10, 15 years and I were looking to more localization again.
>>[FW] My first general practice which was alongside a community hospital so I completely share that. Where we ran all our tests as well, so yes I think we probably have come full circle. Yeah.
>>[RR] And I think patients like that local, that combination of a local service provision, but it still has expert oversight.
>>[FW] Yes. Absolutely. So I'm going to move you on and think therefore we've been pretty positive, so far. Let's think about this funding implication because we heard GPs particularly being concerned about the financial cost to them of delivering a service such as this, but also the nurses talking a great deal about how they would put aside time to do Cytosponge clinics maybe. The whole burden on what's already feels a very full, creaking at the seams primary care service that we have at the moment.
>>[RR] Yeah. I think what this COVID season has really shown is how amazing primary care is and how it rises to the challenge, but, if it's adequately funded as well. I think we've seen with COVID that if the training is put in place and the motivation is there to train and having recently just come from a vaccination clinic armed with my 22 certificates of competence it shows that things can be achieved if the motivation is there. I think fundamentally we're all there to make a difference to our patients and if we can adopt a pathway of investigation that is going to be diagnosing cancer earlier, then that ticks a lot of boxes.
>>[FW] Yeah. I couldn't agree more. Everything you said. So let's think about the logistics then and we got some very useful feedback from some of those interviewees around the way we might organise ourselves, that we already have special clinics that the nurses run, doctors run, maybe around chronic disease like diabetes, but also around, for instance, cervical cancer screening. What are your thoughts on that, thinking about Cytosponge?
>>[RR] Yeah, all the portents suggest working at scale is becoming the sort of the mantra of the day, and certainly of the months and years to come. Certainly, central funding is encouraging us all to get on better and better with our colleagues and our neighbours, and I think the structure, the PCN, if that becomes coterminous with the community diagnostic hub This just lends itself to falling to that structure. So I can see this as this potentially is rolled out. It becomes a very exciting programme whereas we were just mentioning, you get a local delivery of an investigation with specialist and consultant oversight, but actually the GP is involved in that. Again, those of us who've been around bit longer, the idea of actually being involved where we are hands-on is actually quite exciting because we are very much part of making a difference to our patients where they are.
>>[FW] I was interested that during the trial, I know it was the way the travellers set up, but GPs were relatively set apart from the delivery of the test itself. So they watched and they listened and they listened to their patients, they listen to the nurses, but there certainly did seem to be a bit of an appetite to be more involved too, so that reflects that. So I think that gets us to the final area I wanted to discuss with you. It's this whole area of gaining a skill and then maintaining your competencies. I remember very well when I used to fit [coils], I was the only female GP in one practise I worked in, So I had a regular a coil list every week but it was difficult to keep your competencies up and sometimes you might fit 20 or 30 coils a year and another year, just five. I could see as we get into, if this was to be implemented, that we might be in a similar position with the Cytosponge, it might be quite difficult to keep the competencies up. Have you any thoughts on this?
>>[RR] Yeah, and I think what we will see within the PCN and structures is we will get a PCN champion in all sorts of different clinical areas and either through choice, or necessity or just serendipity, you will end up with a PCN maybe with 50,000 patients and maybe 15 to 20 GPs and you will get one of those who becomes the sort of the gastroenterology champion who oversees the service and will be very enthusiastic about it and oversee the nurses who actually implement the service.
>>[FW] I remember in previous decades people kicking back against that a bit about not wanting to be semi-specialised in primary care. Do you think there will still be the role? I mean, what we pride ourselves on as GPs is our role as a generalist.
>>[RR] Yeah, and speaking as a as a cancer champion I would say that almost the perfect combination is to be a generalist with a specialist interest in something. I think that gives you the experience of the breadth of experience, but also an area where relatively you become more expert in it, where you can support your colleagues. I think to a certain extent we've always done that. If you look at group practice and you look at the members of the team each person ends up leading something. As you mentioned very often, the female GP ends up as the coil and women's health specialists, sub-specialists. Likewise, if you're a male GP in what may be a predominantly female line up, you end up as the urology and male health specialists. I think those sorts of things tend to evolve and actually become quite exciting.
>>[FW] Excellent, it's been an interesting discussion. Is there anything else we haven't mentioned or covered?
>>[RR] Yeah, I just think it's a very exciting programme, exciting projects. And I think it just demonstrates how with the advances of science and medical research, how we're able to bring things back to being closer to the patient and actually we become more involved in actually the delivery of diagnostics and delivery of care, which I see to be fantastic and a great opportunity for all of us.
>>[FW] And I hold this up as something of a model for many other diagnostic approaches that we are trying to increase either access to from primary care or indeed delivery in the community. Great. Well, thank you so much Richard it's been great to have this conversation.
>>[RR] Yeah, really good to join you to talk this through, this exciting programme.
>>[FW] Thanks. Bye.
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