Read the transcript of this discussion below featuring Irene Debiram-Beecham [IDB], Siobhan Campbell [SC], Marie Cocoran [MC], Lydia Owen [LO], Jill Ducker [JD] and Nicky Todd.
[IDB] I'm delighted to be given the opportunity to present the BEST3 Trial from a nurse's perspective. A study of such magnitude would not be a success without the commitment of the whole team, but in particular, the nurses and their contribution on the front line in delivery of the device and the study at GP practices. I'm Irene Debiram-Beecham, and my role involved being the lead nurse and clinical coordinator for the BEST3 Trial. As lead nurse, I needed to ensure that all the GP practices and the intervention sites had nurses and the nurses, and relevant team members were trained and ready to recruit and administer the Cytosponge. I provided guidance for GPs on feedback of results to patients and liaised with the endoscopists at secondary care sites through relevant channels in order to book patients who had a positive finding on their Cytosponge test. I will give you a brief outline of nurses involvement, but before I do this, please let me take the opportunity to introduce you to some of our nurses who were key in making sure that this study went ahead at all the different GP practices. I'd first like to introduce you to Siobhan Campbell, who was one of our nurses at the Eastern CRN. Siobhan.
[SC] Hi, my name's Siobham Campbell and I am a research nurse in primary care based around the Cambridge in Peterborough area. I worked on the BEST3 study between 2019 and 2020. I really loved taking part in that.
[IDB] I'd also like to introduce you to Marie Cocoran who was also one of the CRN Eastern nurses.
[MC] Hi, my name is Marie Cocoran again, research nurse based in Cambridge and Peterborough. So I worked alongside Siobhan on the BEST3 study. Between 2019 and 2020. It was a joy to be part of.
[IDB] I'll introduce it to Lydia Owen who was one of our nurses as part of the Oxford team.
[LO] Hi there, my name is Lydia Owen. Yeah, as Irene said, I am a primary care research nurse. I work in the Oxfordshire area in the Thames Valley South Midlands CRN. I was part of a team of three nurses that worked on BEST3 in and around the Oxford area and I have to say it was one of my favourite studies to work on.
[IDB] And next, I'll introduce you to Jill Ducker, who was part of the team at North East and Cumbria.
[JD] Hello. Yes, my name is Jill Ducker I'm a primary care research nurse and as Irene said I was involved in the BEST3 study in the Northeast of England. To echo what the other girls have said, I loved working on the study. I really enjoyed it.
[IDB] I'd like to introduce you to Nicky Todd who was also one of the nurses at North East and Cambria.
[NT] Yeah. My name is Nicky Todd I'm one of the primary care research nurses again, I worked alongside Jill Ducker at North East and North Cumbria. And again, I would say with a really good study to work on and felt really supported by the study team.
[IDB] Great. Following the introductions I'd like to just give you a brief presentation on what the study entailed for us as nurses and to share the nurse's perspective on the BEST3 trial. I'll just share my screen. So the presentation, as I said, will consist of the nurses, perspective on the BEST3 Trial. The Cytosponge device is simple but easy to use too, that can make a big difference to patient who has been on long-term acid suppressant and has suffered with acid reflux for a long time. The study was a cluster randomised, plus a patient level randomised controlled trial. This was carried out across various GP practices. At the time when the study was presented to us, it seemed easy enough and when we looked at the protocol and tried to decide what it actually meant, it seemed that we could potentially do this practically. But we have very limited resources at the time and very limited time and therefore, we needed to put a strategy into place in order to implement and recruit a 109 GP practices and potentially about 13,500 participants. So a study of such immensity, when presented to a team the first thing that springs to mind is, what do we need to put into place? And one of the key things of making this work is extensive planning, having good communication between teams and offering your time when needed. Of course, being dedicated and a strong desire to succeed. We also needed to maximise resources, when needed, and to troubleshoot well ahead to ensure that there was no delays in delivery of this study. So this recruitment strategy, so one of the key things we need to do first was to ensure that we had a secondary care site identified and with that in mind, then we would approach the CRN team to identify GP practices within that region that could potentially feed into the secondary care sites, because one of the key things we had to bear in mind, was that if a patient has a positive finding, then we needed to provide that patient with an endoscopy to in order to, explore why they had a positive finding. So once these primary sites were identified, then they would be sent out the research information sheet, which they would then fill in to express their interests in the study. Once that was completed, then the CRN team would help us to send out the feasibility questionnaires where the GP practices would then complete to see whether they had capacity and capability to carry out the study at that particular practice. Once all this formation information was received, the sites were then assessed to see the amount of patients that they they could pull off their searches. Then of course, site initiation visits were set up and the study teams were taken through the process that was required for the BEST3 trial. So just to give you an idea of the different sites that took part in the in the trial the 109 GP practices stemmed across from Northeast Cumbria all the way down to Plymouth or Southwest Peninsula. We had a number of nurses across all these different sites. Some sites, for instance, Peninsula had one nurse whereas for instance, Wessex had a team of about seven nurses that took part. CRN Eastern in total had about 10 CRN nurses and 10 practice nurses who were also involved in, the study at their particular site. As you can see most of the sites were down the Eastern corridor of the country. I think it just seemed to happen that way. That wasn't our intention. But it seems that most of the GP practices that expressed interest were along this corridor. So one of the things that we had to put into place was once a site was activated, what we'd do is allocate that site a code. So therefore we can identify them ahead of time And also to make sure that we could also identify samples that were collected from that area And therefore, all data was stored under that site code. The searches were then carried out at the practice and the number of patients were then established for that GP practice as to what they could potentially recruit. All contracts were put into place and then a site initiation visit was carried out where we would ensure that GCP and CVs were collected for each individual who were part of the study team at that practice. A start date for the study was agreed and then MHRA had to be informed. Once all these processes were carried out, then of course, we then had our first opt-out letter sent by Docmail. So during this time, we also had to identify which nurses were potentially going to carry out these clinics at those GP practices so that we could align the Cytosponge training ahead of time and prior to them starting their clinics. So groups of two to ten nurses were put together so that we could carry out the training. This just made sense. probably doing it in a central location. So one of the key areas we used was Cambridge, and some of the nurses would travel to Cambridge where we would do a combination of video, PowerPoint presentation and then live clinical procedures. I think the nurses benefited from this and felt that once they knew what the procedure was all about and they can see that the follow through process that they felt that they could then run their clinics independently of GP practice. There were then given the Cytosponge SOP to have a look at before any clinics were established at the sites. Part of this SOP emphasised the emergency procedures that were needed and any adverse events that they might encounter. They were assessed by the trainer and for safety and delivery of the device and also withdrawal of the device. Once signed off, they they were able to carry out clinics independently and with ongoing monitoring by the trials unit. For all the sites across the UK, all GP practices. once the Cytosponge invitation was sent out following the the opt-out letter, those responses came back to Cambridge apart from one site and that was the North East, The North East seemed to do all the screening for their patients and send out their appointments and book them of their GP practices. The rest of the sites around the UK, their responses came centrally to Cambridge and we have ethics approval to see these patients' identifiable data. These patients were then contacted and then they were screened for their eligibility for the trial. Appointments were then booked and then the list of these patients were then sent to the GP practices where the confirmation of the appointment was sent out to the patient. Following on from the clinic the nurses were able to feed back what level of support they would need. When nurses were not able to make the group training, we did one-to-one training at the GP practices and these nurses were supported over a session of two to three clinics until they met their competency. Feedback of the training was overall positive and I will share that with you in my other slide. With regards to [test] results these were forwarded to the GP and in correspondence with the clinical coordinator advice was given to the GP as to which clinical feedback letter was appropriate for each result. These were dealt with in a timely manner, making sure that patients got their results and the follow-up plan was in keeping with between two to four weeks following them having the test. Positive results were then identified and the endoscopies were booked at the relevance and secondary care site. The recruitment phase was quite intense but we allowed three months in order to complete a site before that nurse would move on to the next GP practice. Some of the feedback we had from various nurses wasthat the content of the training was well organised, they had a very informative, very pleasant day they thought the training was excellent, they enjoyed learning about a new scale, about getting more information about the who will experience endoscopy experience as well for them because some of those nurses had not seen an endoscopy so part of the training was doing the Cytosponge within our unit but following that through and for them to see a patient undergoing an endoscopy. So that kind of highlighted the outcome of what could potentially be the outcome for a patient who had a positive result. As a result of of the training and as a result of the BEST3 Trial we thought in order to kind of move things forward that an advice and handy tips document, would be a very good thing to have for future training of nurses who are going to carry out nurse-led Cytosponge clinics. So some of the key things we included on the advice and handy tips document was things like inspecting the device, advice on how to bunch the string in different ways, swallowing techniques, what technique to use if you had a patient that was very anxious, how many times would you use a Cytosponge if it was placed in the patient's mouth. Sometimes you will think, "Oh, they only put it in their mouth" but some people weren't quite sure whether they could reuse that again. So we, we've put together a document where we emphasised some of these, sorts of questions that nurses might have. They also wanted to know, we also wanted advice to be given r be available for nurses on if a patient had continued sort of gagging throughout the whole procedure, what could you do to sort of minimise this? And also, what would the key things on retrieval? What is the key things you would ensure you are doing when retrieving that Cytosponge? So we put together this thinking that when these nurse lead clinics are rolled out that they've got an advice document they can always refer to when running their clinics independently. So I just wanted to highlight because as the coordinator, I had various responsibilities. Some some of these overlapped with the project manager. But most of the time we tried to keep our roles fairly separates, but there were instances when we have to overlap and it was very fortunate that I have the option to work with Beth Muldrew, who was the project manager at the time. We had great support from the chief investigator who is Rebecca Fitzgerald. She was very supportive and engaged and would help us overcome a lot of the barriers that we faced during liaison with different sites, et cetera. So some of the things I had to deal with and was part of my responsibilities was, together with with the project manager, we were liaising with different CRN sites and arranging initiation visits. Also organising the training. When you're trying to organise training for such a wide group of individuals, it becomes quite tricky and you can't offer one-to-one training for each individual. So we had to make a decision as to when group training was appropriate and when we need to do one-to-one training. So that was key to making this, the training aspect of it, a success. We also want to make sure that reimbursement. So one of the things I had to make sure with our finance admin was to make sure reimbursement happened in a timely manner and there wasn't a delay with sites getting reimbursed, especially when they've finished recruitment up their site. Also liaising with GPs about results which I previously said. And in order to engage with the different sites and get various GP practices on board, we had to do a lot of public engagement, presenting a GP forums and CRN events, which then emphasised some of the key things about the study, but also raise interests to other GP practices as a potential study they could take on board. I also managed a small team of nurses and administrators and of course was part of the Cytosponge screening team at our Cambridge hub. We supported nurses with clinics and part of my role was to offer a 24 hour on-call support for their patients as well as the clinical team. So along with everything, you know, this study was quite immense. There was a lot happening on a day-to-day basis and of course, with a study of such magnitudes comes its highs and it's lows. One of the things that was much more eminent in this trial was immense amount of time I spent on the road, and the nurses, the CRN nurses, because they have to travel from practice to practice to see their patients. So it was a lot of effort and we also had to to see patients during that that unforgettable snowstorm back in, I think was it 2018? The beast from the East and you can see the photos on the side that was me dragging my case up the hill in Durham trying to catch a train back to Cambridge. So we encountered a lot of different things such as, you know, we had the weather again says at one point, we had to get rid of various sorts of administrative barriers, et cetera, but with the low comes the high. We built great contacts and networks of nurses. We built relationships with different teams, which meant that we could do future collaborations. I think that really negates the lows for me, and for some of my colleagues. Lots of nights a way from home, but that also meant we could progress the study. It meant that being on site we can troubleshoot things ahead of time. It also meant we could give the nurses and the team support where needed. This also helped them to be more engaged and committed to completing the study. Yes, there was a 24-hour on-call, but the teams and the patients were so respectful of my time that they really didn't take advantage of that and only phones when they absolutely needed assistance. The low side for some of the nurses from the training aspect was where we trained nurses up and then they they left before they were either signed-off or they had a chance to complete recruitment of that site. Therefore it meant we had to retrain some of the nurses but it also meant that the majority of nurses and this is across all the different practices were committed. They worked at a very high level and made sure recruitment was completed on time. We had some diagnosis of cancer and this meant that despite being a low for the patients and maybe some of the nurses, it also meant that these patients, because there were early [detections of] cancers these patient could get treatment quicker, and because it was an early [detection of] cancer, the treatment was effective and therefore the patient had a good outcome. So again, with some of the lows I think the highs really negate some of those lows. And really, the BEST3 trial was a success really because of the commitment from all the individuals who took part in it. So in conclusion, the findings from this trial have made a difference to a number of patients and has highlighted the next steps needed for successful implementation into routine clinical care. It has highlighted that we need dedicated nurse-lead clinics and time to do these clinics. It has helped us to standardise the processes for clinical roll out. It is helps us also to streamline the documentation for recording of the procedure, but also providing information and enough of that information for ongoing audit. It has to establish the need for putting measure in place so that the nurses competencies are maintained after training. It has also helped us to implement a train the trainer module so that nurses already trained could disseminate some of this training to other colleagues. The need for the Cytosponge nurses network has been a growing need that I became more evident during this trial because of the vast number of nurses we trained. And therefore we're making progress in developing a nurse's network across the UK and Scotland. So that nurses can share their experience and knowledge and offer support to their colleagues. So thank you everybody for all you've done and for making this study such a success. Each and every one of you have played a significant part in this study and in making sure that we deliver the study on time and safely. Thank you. So now we'll move on to the questions. I'll stop sharing my screen. So it's very nice to have you all as part of this group because I think we have a lot to offer and we've had a great experience delivering on this trial. And therefore, I want to go back to when we, first presented this trial to you and the Cytosponge device. I know it's a little while ago but the questions I'm going to kind of put to you are question that have been raised by other people along the line. So it'd be nice to get some feedback from you. So what was your first impression of the BEST3 trial and the use of the Cytosponge device? Who would like to take that?
[NT] Well, yeah I think our of our first impression was 'no way'. To be perfectly honest. I've just looked at it with absolute horror because the immediate thing that jumps into your mind is what can go wrong. I thought the study itself was really good but I looked at what could go wrong and we did say at the beginning
[JD] And I think when we went to Cambridge for the training and then we saw the Cytosponge delivered and on the way back on the train we talked about it and said, you know, "You're in a hospital there, you've got everybody around you, you've got all the support if something goes wrong, we're going to be the GP surgery in the middle of God knows where!" and when were very, very anxious. I think that's a fair comment, isn't it? At the start.
[SC] I had a completely different reaction. Now I will say my background is intensive care, so that does make a difference, I think. I remember the moment almost it was discussed in the office where I was standing and I just thought, "I want a piece of this!" Even before Marie had started and I remember one of my colleagues had a similar reaction to you and I thought "I'm relatively new, but I really want it" and I just said "can I have this one?" You know, because I could really see I think because I've seen so many people die of oesophageal cancer, and it was a long-term memory for me even when I was a student, the horror of it and, and the lovely people you lost. I'd see that surgery and how brutal it was and this just seemed like an ideal - I almost get emotional about it - An ideal, really good way of saving more lives and getting the intervention in earlier, making a difference to people. And so that was my first reaction.
[JD] I think we saw the positives of that, but I think that was the actual delivery that frightened us until we got to know more about it.
[MC] I think I thought, "Oh, what a clever idea, who came up with that? What a clever idea." I'm not sure that I would be good at swallowing because I'm not good swallowing tablets, So I did have that thought, but I did think, "Ooh, that is a clever idea."
[SC] In terms of risk, the way I looked at it though early on was, I had seen people have endoscopies, lots of them, on critical care and I knew how brutal that was. To my mind, something that fits in a pill, is compressible, is going to do so much potential less harm than anything else. You could do those all day. Every now and again an endoscopist with
[perforate] an oesophagus or do some severe damage and that you're much less likely to with this, it's a much gentler approach on people. As a first approach I thought it was a really good idea.
[NT] I think for us though it was a bit off-putting as well when one of the GPs said "well, I wouldn't want to be the string puller."
[Laughter] That didn't help. But as I say, that was right at the very, beginning before we'd even had any discussions. It was just flagged up to us and "have a look and see what you think." It just shows you how you can completely turn it around.
[MC] Change your mind.
[SC] I will say, the first time I pulled the string, Irene was there with me and I thought "seriously, this hard?"
[Laughter] I'm thinking, I've taken out NG
[nasogastric] tubes and done all this, this just feels a bit, "what's going to come with this?", you know?
[SC] Ok, you have to get your head around that, so I can really see where you're coming from. It is bit daunting.
[IDB] And Lydia.
[LO] Yes, I was impressed by how well organised it was and the training that we had. I think my initial thought was, "how on earth am I going to get somebody to be able to swallow that pill?" And I knew that I would be able to, but I don't have a particularly violent gag reflex, but my colleague, Diane, who also was one of the nurses on the trial, she said "I couldn't do it at all." So I was thinking it might be a bit difficult to get people to actually swallow it. So that was my initial thought. But, like you Marie, you know, wow, what an amazing idea to reduce having to do an endoscopy.
[IDB] And what do you think about the swallowing? What do you think would put people off? Could it be the capsule, or the string?
[MC] No, I found was the most irritating thing was the string. People are used to taking capsules and the capsule is probably no bigger than the big multivitamin. But the string is weird. The string feels weird in somebody's mouth and feels weird on the back of their tongue. So the key would be just to get it in and get it down, get it off their tongue as quick as possible. The less time they have to think about it, the better.
[LO] I think when you swallow a pill you swallow it and know it's gone, don't you? Whereas if that pill is attached to a string and you know that you can't swallow the string down. That is what a lot of people were concerned about. The thought of having a string there and not being able to do anything about it, and still being willing to do it. It's amazing.
[NT] I think we were quite surprised, actually, the amount of patients who agreed to do it. The consensus was that a lot of them had endoscopies at some time in the past. They actually said "this is a doddle compared to that." So I think that made it a lot easier for us as well, didn't it Jill?
[JD] It did.
[SC] What I noticed about it was adapting to the string that people will think, "oh, I can easily do that." and they look at the pill, and think "that's not a problem at all." and they'd be dismissive of the string and I had to kind of explain when I watch people do, it was like, you know, trying to wean your baby onto food, the way the tongue would make this strange movement because none of us have any idea how to get string to go down, so you had to really reinforce this is going to be strange and you really need to try and bypass your tongue as much as possible, because that string - I can only imagine, I never got to try it myself, I was really quite keen -
[IDB] So there's another question. If you could recall one memory of your clinic, what would that be?
[JD] I can recall a lady who swallowed the capsule, had the string there, we sat there the length of time and then she refused to open her mouth to let me pull it out. "You're not taking it out."
[she said] At which point I'm thinking, what do I do now? But we persuaded her and we did take it out. She was a character. Nicky, I'm sure, you know the lady I'm talking about
[NT] She certainly was.
[JD] She wouldn't open up. She wasn't opening her mouth for me to take it out. So that was my one abiding memory, but she was a one-off.
[NT] She was and I think for the first one for us as well, she was a lady who is about I think, we were with you, Irene, she was about 82 and she was tiny. She just swallowed it down, we sat and had a conversation, pulled it back up and She just said "is that it?"
[JD] I think she said something like"I've had babies, you know, couldn't be any worse than having a baby." Something like that. I think that was the very first one I did with you, Irene.
[JD] And that sort of made you think "oh, it's not as bad as I thought."
[IDB] And Mary,
[MC] I remember a gentleman and how it was fairly early on in the whole process. I thought, because he was, I mean, he was a military man, so I thought "oh he'll be easy." You know? He's been to war! This is nothing. And how wrong was I? Because I will never forget him and he was the hardest person. I thought he was going to go into spasm. I really thought I'm going to have to put my foot on his chest to get this out. So yeah, lesson. Yeah, I can still see his face, but it all ended happily. But yeah. You can just never assume. You just never assume, you know, this one's going to be easy. You never know.
[IDB] Was he alright, after it?
[MC] Oh yeah, he was fine, he was fine. I was sweating.
[SC] Oh, yeah, a similar one like that but the other one that stands out is, I remember we had a very anxious lady who came in with family even as well because she needed a lot of support and she really wanted to do this. But even on the first appointment she just wasn't, she was so nervous that I said, you know, "go home. Have a real think about it. You're not obliged to do this or anything." I can't remember, where you with me or not, Marie? You could have been. But she came back an extra week and she wanted to do this. And, you know, and she was really keen and we just took plenty of time. We had known she was coming, so we needed to give her plenty of time, and she actually did. It was that sense of pride that she felt when she went out, that, "I've managed to do this. It frightened me. I really wanted to do this." And we were then hoping it wouldn't. I will say, she was one who had to come back for an endoscopy you know, in the end.
[IDB] Oh dear.
[MC] So hopefully they found some benefit to her. But I thought "oh, it would be, you know, the one who would still have to go further." Because she was a lovely lady. That's the one stand-out, I supposed.
[LO] For me it was, I remember one participant who was quite a young chap. Once he'd swallowed the capsule and was waiting, I said, "You know, it's up to you what you want to do." So he got out his phone and he started to play Candy Crush.
[Laughter] For the full five minutes he play Candy Crush or we probably waited a little bit longer than that. Yeah, so that was probably my...I mean I've got lots of memories but that for me is a particularly different thing. Yeah.
[IDB] I kind of presented my highs and lows and some of it will be a bit similar to what you experienced. What were some of your highs and lows of the study?
[JD] I think for me, the lows were probably the fear at the beginning. But the high, the main high I have to say was the support that we got. I'm not just saying that because you're sitting here, Irene.
We've talked about this a lot since and the BEST3 team were one of the most supportive study teams we've worked with. think that's probably why we enjoyed working on the study because I didn't expect to enjoy working on the study when I started, but looking back, certainly, and I know Nicky did thoroughly enjoy it and that was that was due to the excellent support we got. That was the main high for me.
[SC] I will have to thoroughly agree with that as well, you know, it was really good. Also the patient response and the people who came in, the varied and different people who came in and they had all sorts of things going on in the background, and they're still volunteering to take part in research because they're hoping it'll do [good]. I had someone, 95 or 96, coming to take part in research. You're just thinking, "oh my goodness, that is amazing." If there was one thing I would say, maybe some of our practices struggled with the spreadsheet system and things like that and the LTE. I have some who still say, you know, "just don't come near me with stuff like that" and other people it was just like "I don't know what the problem is." So that was the only thing that was a challenge for us within some practices. Yeah, no great team to work with.
[MC] I have to say, no matter when you phoned, if you were phoning for whatever reason, there was always somebody there, the end of the phone to talk to, which was very reassuring I have to say. When you had a question or query.
[LO] I think Beth probably got a bit fed up with my phone calls to be quite honest. I was always phoning her. For me the highs were getting to work with great teams in primary care sites. I really loved watching the clinics fill up on the database. I'd look quite frequently to see how my clinics are filling up. For me, a low was there were three of us nurses working on this study from our team and I got the most low confidence results of all three of us. So for me that was a real low of the study, actually. Getting more low-confidence results than my colleagues. Apart from that, I agree we did have fantastic support from everyone.
[NT] Yeah, I would just agree with all of that. The other thing was the rapport you built with the patient, because it started with the phone calls and you felt you'd started a really good relationship then and then when you saw them. We had one lady, I don't know if you can remember, Jill, She said she didn't mind if she had to come back again because she'd really enjoyed "the craic".
I think the lowest for me was when they couldn't swallow it because you kind of felt a bit of a failure yourself because they'd try twice and they could get it down and especially if they really wanted to do it and they were really disappointed. So I think that was probably the low for me.
[IDB] And those are all valuable things, I think. I've done a number of these clinics and there are so many experiences I can draw upon. And it's, you know, there are good ones, there are bad ones. But thank you very much for expressing what the highs and lows of your experience with the study. Having had experience in doing these clinics, what would be your advice to another professional setting up a similar clinic?
[MC] Prepare. Spend lots of time preparing. Yeah. Kind of go through scenarios that you might come across and have a process ready to deal with whatever you might come across.
[JD] Have some support there with you at first
[JD] Until you get more confident just in case something does happen so you've got somebody that for a bit of backup until you get confident. That's what we did isn't it, Nicky? At the beginning.
[NT] Yeah. And don't go with your first impression.
[NT] Get over your first impression, and think about how valuable this is going to be. And have that support network because even if you've just got one person in the room or even in the room next door to it it just makes you feel more confident knowing that you've got the support network there. I agree with Jill on that one.
[SC] I think always knowing that you have prepared for the worst if things go wrong. So it's kinda like expect the unexpected. I'd almost have pre-printed referral forms in case you had to send people off so that you could just quickly print something off, add in the necessary data and have a GP back you up and arrange that. So even with things went wrong it was very smoothly dealt with. It's having that mechanism in place early on, I think, would make it different.
[MC] That helps with your confidence as well, doesn't it? If you know exactly what to do when you're there.
[LO] And I would say to make sure that you use checklists for all your equipment. So right at the beginning to create a checklist and make sure that each clinic you do tick off everything because for the study, there were a lot of processes. Maybe if it wasn't as part of the study, there would be less, but you still need to make sure that you've got your equipment and also, all the processes that you have to complete as well. Yeah, use checklists definitely. And also one of the things I was thinking also is about managing the expectations of the patient. You didn't need to right at the beginning tell them that "you may well gag, you might feel the string at the back of the throat. I mean, I know that's all things that we do, but certainly if I was telling somebody that had never done a clinic before, that's probably what I would say.
[IDB] Thank you. So just moving on. There are a few more questions to go. When would you recommend the use of local anaesthetic and how would this be helpful to a patient during the test?
[MC] Not a fan of it, I have to say.
[IDB] You're not? Yeah.
[MC] No. I might have used it once, maybe twice and even then I think we both had people who came back for a second one and they didn't have it the second time.
[MC] I think people who are far more interested in having their cup of tea or coffee or whatever towards afterwards.
[SC] Ice cream.
[MC] Ice cream, yeah.
[NT] We didn't use it at all.
[IDB] Oh did you not?
[JD] We offered it.
[LO] I think I used it three times. Three times at most I would say I used it. I think if they know that they can have it but they can't have it until they've swallowed the capsule then I think most, most people said, "Oh, I'll see how I feel." and then when they found that it was okay, it's tolerable. They said, like you said, "I'd much prefer to be ale to have my cup of tea"
[IDB] A drink, yeah. Yeah. I've noticed that as well in some of my clinics now that we're rolling it out, that they really do want, they've been nil by mouth for four hours and therefore they'd really like to have a drink, they'd really like to have something to eat so that the chances and the thought of them having to wait another half an hour to an hour before they can have something. That really puts them off.
[SC] I never really saw, there wasn't a huge amount of benefit because the most you can get s the top half here. When you really, possibly, it's here. the most uncomfortable going past. It's not really effective at that level for people. I'm not too sure they felt much pain in the back of the throat because the so much space there for it to come out at that stage and it's very quickly gone. Yeah, I think most people were quite happy. I did have one lady who had it the first time. Hadn't the second and said "Oh yeah, I didn't really notice the difference." So she was quite comfortable. She recommended not having it.
[IDB] I think that the instances where I use it is where the people have very sensitive gag reflex. So from the time the sponge goes down, that just having that string at the back of the throat just causes them to gag and cough. I think once you're confident enough that the sponge has actually gone down, I think that does help them a little bit to, put a little bit of spray. The reason for that is because if somebody continues to gag and cough, the chances of them coughing the sponge up is much more likely. And therefore, if they cough it up into the middle of the oesophagus, it means that when you are ready to pull that out, you're not going to get a very good sample. So I think those instances that's when I would recommend possibly a little spray where that patient's got a really strong gag reflex and they're not able to tolerate that string of the back of the throat.
[SC] Its funny because I will say that rings a bell with me because sometimes people who gagged a lot, I'd pull our and I'd say "I don't think that's done." I think I've spoken to you before. It would just be at the back of the throat now whether they gagged it back up or it was irritating because it never went down. I'm sure with some of these people they swallowed the second one and they were absolutely fine. So your point is they could have retched it up too so that's quite interesting.
[IDB] Yeah. But it's something to bear in mind. I think you know. It may not be what the patient wants but you might be able to assess to see whether it's right for that patient if you know what I mean. What are the side effects of having the procedure and how would you mitigate some of these risks? Can you remember some of the side effects?
[MC] A sore throat was the most common thing, which lasted for a couple of hours to maybe the following day or something like that. That was the most common thing. We just warned them about that, to expect it and if they wanted to take few analgesia [pain relief] that was fine or we used to have a cold drink, ice lolly used to go down quite well. But I mean, generally very well tolerated, I think.
[IDB] Anyone else?
[LO] There was always the risk of bleeding, wasn't there? I think of all the people I phoned after having the procedure I think one had bleeding, but not a lot, had just coughed up some blood. I think it's just again, managing their expectations. Letting them know that they may well do it. Obviously if it's lot then they would need to contact the GP or if it's really excessive for emergency procedures, but yeah. Just let them know that they may will cough up some blood.
[SC] Increased heartburn I suppose was maybe the one but they normally did have some medication and sometimes some of their liquid antacid would be quite good for that to help to relieve that. Something over the counter would relive that for them, probably on top of the omeprazole which they all were pretty much on.
[IDB] Anybody else need to add anything else to that? How would you deal with a detachment? Or if somebody had significant oesophageal spasm?
[JD] Thankfully, it never happened to me. But I think you knowing that you had a GP in the building for a start, somebody that was close by that you could ask for help, knowing that the endoscopy unit were aware that you were doing a clinic and, hopefully you wouldn't need to contact them, but knowing you have that backup, I think was always reassuring for us. I don't know if it was reassuring for the patients, or scary for the patients really to tell them that if something happens you would have to go straight for an endoscopy. I think most people assumed you would let nature take its course and it would come out the other end and I think it was when you said that to people "actually no you can't do that. We'll have to get it back up." I think that was possibly the bit that frightened people a little bit. But I think it's just reassuring people that there was expert help on hand if needed.
[SC] We did have a detachment in our area that was over at the Norfolk team. They dealt with that They said it was very streamlined because you have the GPs there who know they're doing it they just did the referral. We had a secondary care site on standby and actually the patient was really impressed by how it was handled. That's why I think it's important to people who are setting up clinics that they have these things streamlined so there's an obvious "this is what you do for the detachments or the bleeds." In case of a spasm, I think it's very much a case of settling people down, just get them relaxed and give them some time because the spasms should settle and it's something I'm sure most GP practices are used to dealing with panic attacks and helping people to relax. Hopefully that should come out by itself or else it would be a referral if, you know, 20 minutes of just relaxing somewhere didn't help. Irene will probably have a better
[story]. You've dealt with them, I know you told us a story about a consultant actually before we started. He himself went into spasm and he went around for a couple of hours with a string hanging out, looking at notes and through it, all sorts with the string hanging out of his mouth just until it'd sorted enough for him to get it up, which I thought was great story actually.
[IDB] Yeah. On the BEST3 trial, we had one detachment and that was with over 1600-odd patients. So that's pretty good going, isn't it? I can only recall from the Norfolk team that was pretty straightforward and the way they arranged [the procedure] was pretty slick and everything. I happened to be in Norfolk at the time when it happened so I was just around the corner from them. So it was great and we had a chance to debrief and I think sometimes that having encountered that yourself, from a nurse's point because you know that's the unlikelihood of it happening, is such a rare thing that when it does happen you need to kind of talk about it. It was nice that they could then come meet me at one at the GP practices and we had a little bit of a debrief. And it was fine then to kind of talk through whether they could have done anything different. In some of these cases there's nothing else. You've done everything you can, and it's just one of those things. So I think it was pretty good that we only had one detachment. I think that just shows the robustness of the actual device and really shows that the device is pretty safe to be in individuals. Did anybody else have any spasms? No. I remember there was another patient recently and one of the ladies said to me, she just, the patient had the spasm and she said, "Oh, all I did was I got them to swallow it back down and I'm just got them really sort of more relaxed and then within a few minutes she was able to retrieve it." So I think that's key. I think Siobhan you touched about that. You give the patient sufficient time. Sometimes patients are so anxious, about this thing being pulled back up that all the muscles around their neck just tighten up even before you even touch the string. So sometimes if you can implement different ways of making that patient relax then that probably would go a long way as well. We're nearly there girls. So the patients has 7.5 minutes now for a capsule. I think when we did the BEST3 trial, it was five minutes so it wasn't too bad and you could kind of get on and do some of your paperwork, et cetera, or talk to the patient if the patient felt inclined and they wanted to continue talking. But now it's 7.5 minutes, it's a little bit longer. What would you recommend the nurse or healthcare professional to do in that time?
[JD] Talk to them. We used to sit and natter. We didn't do the paperwork or anything we just used to sit and chat about holidays, children, grandchildren, the weather, anything to distract people. I think most people seem to quite like that to take their mind off the fact they've got this bit of string dangling there like a teabag We used to try and avoid actually doing anything other than sit and natter to them during that time. That seemed to work, didn't it?
[MC] Yeah, I think distracting is the best way if you can.
[MC] Most people are good at, yeah, if you distract them. I suppose the only other thing is that some people might find it more relaxing to sit there with their eyes closed and go somewhere else. So just kinda figure out which side of the fence that your patient falls on.
[NT] Yeah. I think we did have a couple, I have to say, the men who said, "don't talk to me, just let me sit here and I don't want to. You can talk to me, but don't ask me questions that I need to respond to."
[LO] Yeah I mean, I think it depends on
[them]. So I always used to say to them, Do you want me to talk to you or do you want to be quiet or do you want to do some of your own? Often they would have brought a book or a magazine or like this chap that played on his phone. Obviously if they wanted to talk to me, then that was fine. I did spend the time writing out labels and all sorts of, you know, filling out documents and things. Just so that I had everything done and can clear everything away before the next participant came in. I found it really varies according to what they wanted.
[SC] Going forward I think for people, practice nurses probably, doing it on a day-to-day basis, they'll know their patients know their individual quirks and things. I mean, some people, they might use this time to catch up on things, making sure they've got the right details on the notes, if they want to talk to them, or do the other things that need to be gotten on with. It's a real time to even talk about their health, and how they are in themselves. You know, you can do so many quick assessments in that time along with other things for them that it can be an opportunity. 7.5 minutes is quite a time really, but it is very much up to the individual person, what their comfort with. Nobody really knows how they're actually going to be for those few minutes. How are you going to actually react to the string being there all the time as well, so. Keep an eye on them anyway.
[IDB] All right, great. So what are some handy tips for good swallowing technique? What other tips would you recommend to other colleagues? What worked for you?
[MC] To swallow I would say have two glasses of water ready to hand. Basically the key is to get it off the back of their throat as quickly as possible. So to explain them clearly and nearly try and get them to visualise themselves that they need to wash this off the back of their throat, and to do that, they can't sip the water, they need to take huge, big gulps of water and basically visualise washing it off. We use to get them to finish nearly one glass of water, neck it, if they could. Gulp, gulp, gulp, you know? Don't stop, don't take one gulp and stop, you must try and keep going and basically wash it all the way down into the stomach. Then we would have a check and make sure there was no string or anything hanging around the back. That seemed to work for the majority of them, I'd say. Siobhan, would you?
[SC] No it did, it worked very well too yeah, if you've got them to just, as you say put the first one down really really quickly. That works. Making sure the string was well bundled up together and they put it far back. I felt that they were often more successful. They pushed further back than I would, so letting them put it right back, and I'd say over the hill of the tongue. Just to say "If you can do that and then get that down it just makes it a straightforward trip down. That used to make the difference. If there was lots of string around we might help with poking that back for the next one and do gulps but you used to always despair. No matter how many times you tell people, every now and again, you'd have somebody like they were just having a little taste like a first sip of wine, and you think it's just going to get it sticky.
[NT] Who does that?
[SC] It sticks, does not cut the mustard.
[NT] I think we found the opposite. We found it easier for us to put it in. Most patients preferred that than them putting it in themselves. There was one or two that did it themselves but on the whole, most patients prefered that we actually put it into the back because sometimes it was too fiddly for them to get hold of anyway, but they just would say "no, just go on, just do it."
[LO] That's interesting. So I would give them the choice and most people chose to do it themselves. My little phrase was similar to over the hill but I would say over the crest of your tongue because people know what that means. So yes, it's like hill, isn't it. Over the crest of your tongue. That seemed to yeah, strike a cord with people, you know, when you say things. So if you just say that your tongue, you know, that doesn't really mean anything because it's different things to different people but if you actually know that it's got an almost disappear. That made it easy and big gulps of water.
[SC] I felt that they could estimate their own gag reflex better so I didn't want to be pushing it too far back, I suppose, if they were happy to deal with and I've watched them, I think, wow, that's further than I'd put it but it just meant that you reduced your low-confidence rates, hopefully anyway.
[IDB] Jill, anything to add?
[JD] The only thing I would say as well is
[that] we found it helpful to practice string beforehand. Because you don't want to look as though you're fumbling in front of the patient. I remember we sat in the office with one of the practice ones and people walking past thinking, "What on earth are you doing?" We were practicing folding the string to get it all bundled ready. So, your string technique, I think is fairly important as well.
[MC] Yeah, we spent a lot of time trying to figure out a way to do that.
[MC] There must be another way of doing this. We didn't find another one, though.
[SC] There's still always every now and again you just think "oh sorry I need to redo this"
[IDB] Yeah. Well, now we've got two different retainer so you can actually so to use the retainer to help you.
[JD] Oh, excellent.
[IDB] So it's a little bit different because it does help some of the nurses now going forward that potentially use that to just get it nicely wound around.
[LO] I have to say sometimes I would just, around my gloved fingers, wrap the string around, and then take it all off in one bunch. Like that.
[IDB] I think the only thing I'm quite conscious [of] is when they do that is that they don't overlap the string because the potential of it, kind of knotting then.
[LO] Knotting, yeah.
[IDB] I've had some incidences where they've kind of overlapped it and swallowed it.
[LO] Yeah, I can see that could potentially happen.
[IDB] Yeah. But you know the patient got it down and you think, "Oh yeah, well, they've got it down" and then when you pull it up, there's a big knot in the string and then you realise, "Oh, that probably didn't go all the way down." It's just, you know, I suppose with this is you have to, when you're doing this technique, you have to find what works for you.
[IDB] And there's various ways of bunching that string, but I agree with Jill. It needs to be done properly and it's best practice doing them because if you get it right and whether the patient takes it from you or whether you put it behind the crest of the tongue then, you know, it's important. That first swallow is so important to getting that pill down. Just a little bit about the parts of results and I think for nurses out there, what do you think you can tell them a low-confidence result means, and how would you overcome this result? What are some of the scenarios that you could remember where you got low-confidence results?
[LO] So I don't remember my training being told to position string into the centre of the tongue to retrieve it. I did get quite a lot of low-confidence results and I was chatting with one of my colleagues and she happened to mention it. So I said, "Oh okay, I don't remember that part." So I did start doing that and actually it definitely improved my low-confidence levels of the results that I got. So making sure that the string is sort of pushed back into the centre to retrieve it.
[IDB] Anybody else?
[SC] So to my mind, a low-confidence result just means that didn't go down the entire [way], didn't go into the stomach, we don't have stomach cells. It's not something for [participants] to be concerned about, but I did notice that some of them were, quite a few of the ones that I had were ones that had other issues, potentially with swallow. They had other maybe muscular weakness issues, muscular dystrophy, early stages of things that maybe would have affected their [ability to] swallow. So it's really important to do a good patient assessment, that it may not work for patients and that it may not even be appropriate for you to put them through that when it's not going to succeed. So it's knowing that they have no problem, which we do to a degree, because we did ask them. These people will have no problems swallowing pills. But it's just, I think with the string was the extra complication. But the key, I think for me is the good swallow technique. An early good strong swallow if the sponge is as far back as possible, that worked really well.
[IDB] Good. I'll just move on quickly. How was a positive result received by patients? Can you remember any of your patients getting positive results and what did this mean to the patients? Can you recall any of those incidences?
[MC] Well, I think we discussed it with them when we're doing the consent so that the options of what would happen is it would be negative or it could be positive or could be indeterminant. So those are the kind of options that would follow from the procedure. So they knew that if they had a positive result, then that would mean that they would end up having to have an endoscopy to confirm. You also kind of had to explain to them that this doesn't mean anything dreadful might be happening, but they do need to go further and just confirm what is going on.
[SC] I myself was never involved in giving the diagnosis back it was always given by a GP and then study team yourself dealt with the follow-on. So I never really had experience of that.
[LO] Same here.
[NT] No we didn't either.
[IDB] Okay. And what follow-up mechanisms would you advise to have in place?
[LO] Well, I think definitely to have regular training updates would be very beneficial because it's just useful. If I was asked to do a clinic now I would definitely want to do a training update just to re-hone some skills.
[SC] I read that question slightly differently in terms of, is that follow-up mechanisms for clinics like you're running? My only thought on that was I really do think it was really valuable for patients to know that they could ring mostly you, Irene, you know, for the following week if they could. I just think if they had a named person that they could ring at the practice that even if they weren't able to answer would ring them back or get back in contact about that. so that they could talk about their worries, for the next week or so if they had any concerns on that aspect. Nighttime calls obviously can't be dealt with, they can go through the usual services for that. I think it's really nice for them to feel "If I feel anything's different I have somebody I can directly talk to."
[IDB] Do you think the seven-day phone call helped with that because you did that following the procedure that kind of alleviated some of their anxieties, do you think?
[SC] I think knowing you with there meant a lot to them, actually. We'd say you're there day or night and they felt really good. What I really like then was, did you get many calls at all, Irene? I don't think you got many at all. So I think that was just being there is enough and putting that in place makes a difference to people.
[LO] I'll tell you what else I liked, was the actually feed back on the BEST3 database from the patients. I know that's different but actually that was, really helpful to me to see that actually, most people found it was very tolerable, they'd had a good experience and that was really encouraging.
[IDB] Then from a nurse's point of view, that kind of boosted your confidence, didn't it?
[IDB] And it gave it a reassurance you were doing something, right?
[LO] Yeah Mostly the chatting, I think for myself and Marie.
[NT] I think early on into the study when we'd a few patients down the line, you really started to enjoy it, really started to enjoy it. As I say, I think the rapport with the patient as well and and listening to them, the reasons why they wanted to take part and why they're happy to have it done. I think most people, I think maybe we had one or two that after the full explanation backed out, said "no, I don't want to do it" Most patients went ahead and had it done. I think building up that rapport and actually enjoy really enjoyed doing it and feeling that "wow, I'm contributing to something that's going to be really, really valuable in the future."
[IDB] Well, it's been great having you all on the panel. I think it's been a great discussion. I think you've highlighted some of the things we need to take forward and you've identified some of the things that we probably still need to address. I think having a network of nurses, going forward we'll provide that platform for nurses then taking this on in a clinical setting. Thank you all very much and thank you for your contributions The the BEST3 trial. It's been a pleasure working with all of you.
[NT] And you.
[JD] All have lots of nice memories.
[NT] Do you have any ideas on timeline, when it's going to be rolled out?
[IDB] Yeah. So we've worked with the Scottish government at the moment and they're actually rolling this out in clinical practice out in Scotland at the moment. I think this being in a pandemic has kind of fuelled this a little bit in getting it into clinical practice. So we've done a lot of the training up in Scotland and they are now using it as a device for both patients with dyspepsia symptoms and reflux symptoms, but also patients who are on Barrett's [Oesophagus] surveillance. We're now working with NHS England to kind of roll this out to centres around the UK, or within England, I suppose, not the whole of the UK just yet, to get these set up in secondary care units. The other thing is we are looking into setting up a mobile unit where we could potentially reach individuals who have got problems, getting to their GP practices or feel really intimidated by going to a GP practice, but have symptoms and we thought starts probably making it easier for individuals where you're offering a service, but it probably doesn't impact on them going to a GP practice where at the moment they've got limited access, etc. It might make it easier for some of these patients for the uptake of the Cytosponge in these areas. So yeah, we're working on a multitude of ways and things and making sure
[IDB] that we can bring the Cytosponge to those who actually need it. This could have not been done [without] all of your contributions and your hard work in making sure we fulfilled the requirements of the BEST3 trial.
[SC] We were lead by the best!
[IDB] Thank you all very much and thank you again for giving up your time to be part of this, presentation, and for your valuable input.
End of transcript