So the best way I would say is literally when I’m-, I go to the ward. Each day they’ve got their own handover sheet, so I walk onto the ward. I’m usually like, “Morning guys,” and they’re like, “Oh, what-,” go like, “There’s no blood pressure ladies here for you,” cos that was one of the main studies that I was always looking for. But then I-, I’d say, at the same time when I’m looking at like the handover sheet, I’m always ex-, I’m explaining to them that I’m also looking for pre-term ladies and everything else. So as well as myself screening for them-, so they actually know that now it’s blood pressure ladies, but now hopefully, in time they’ll be like, “Oh yes, we’ve got premature ladies- labour ladies as well for you,” and stuff like that. So, I would say not only shall I say, just screening the actual physical paper, but just every-, I’m like-, I walk on and they’ll know that I’ve came on to the ward today [laugh]. And then talking to doctors so, thankfully now the doctors actually flag up when they’ve seen a patient. For example, in clinic they’re like, “Oh Osi, we saw a-, I saw a lady in clinic,” and they can remember their names, it’s usually great. They’ll give that to me and then I can source out that lady – when’s the next time she’s coming in or what-, maybe she’s actually ineligible and stuff like that. We’ve-, we’ve had a commercial study which was looking at fibroids and reducing heavy menstrual bleeding, and within that study we-, I -, cos-, so there’s many clinics where they could potential-, there wasn’t a set clinic for fibroid ladies, it’s fibroids are usually found in the secondary problem. So I just introduced like a screening sheet and I left it with the head nurse on the clinic, and just said to her that every-, “If you guys remember,” cos the information leaflet was right by it, so I said, “When you guys take an information leaflet to give to the lady, if you can just pop her name down and her number and then I can get in contact with her on a future date”, or they can give me a call and if I’m around I come up and speak to them directly.

I would usually go, I would either do it in two different ways, I work with the neurologist and with another consultant who does care for the elderly and they either suggest patients or CC me into the bottom of clinic letters that they think may be suitable for whichever study or I’ll screen a clinic and I’ll pick up patients that I think are gonna be suitable and then run it past them, if they’re happy for me to approach that patient. And then I usually send them like the patient information leaflet and then ask them to contact me either by telephone or e-mail if they wanna take it further or if they wanna ask any further questions. Or I might catch up with them at a clinic visit if I see they’re coming in for a routine visit I’ll pop and see them and introduce myself and say you know, I’ve got this study that you may be interested in taking part, this is a brief outline, take the information home with you if you think you’d like to have like to have a think about it take it further then get in contact with me and we’ll discuss again. And very often you get a positive response, more, I’d say 8 out of 10 times you get a positive response.

The patient information leaflets come from the trials. But it’s, it’s your own communication skills it comes with, I’ve been nursing for 15 years now, it’s something you learn to do, and you work off their cues, their verbal cues, their non-verbal cues. And you talk in a language that they can understand. Some people are, are very, very knowledgeable and they tell you that this, and you’re discussing them and they take you off on a tangent about some other trial that was on. And some people just really don’t know very much about it and just need it in very plain basic English, and some people don’t want to know anything about it. They’re happy to take part, they know that it’s going to be a chemotherapy drug but they don’t really want to know too much. So, it’s all about the conversation that you’re having with the patient. It’s all about the discussion. And there’s no set rules or set laws, you have to gain an understanding that they know what’s going to be happening to them, and actually what they’re consenting to. But that level of knowledge you have to discern as a nurse to say that I have to sign to say that I am sure that they’re aware of what they’re doing.

And that’s just through conversation.

And I always try and make sure that they understand the impact on their lives. So, often people might be quite interested, especially if it’s a new drug that they think might have a wonderful effect, and they’re very keen to be part of the study. I do just try and make sure that, OK yes, it might, but you’re also going to have to come for 20 appointments, and you might be here all day on some days, and sometimes it’s really boring and, you know, we try and make it as pleasant for people as we can, but you know, the nature of the work that we do there’s a bit of hanging about and waiting for pharmacy.

So, I just try and tell people that upfront cos I don’t like -, I wouldn’t -, I wouldn’t want to be part way through a study and, you know, have a nasty surprise, or think, ‘Oh well, you know, I can’t do this anymore,’ or ‘I’m too busy or work’s too much,’ or whatever, and we do try to be really flexible and accommodating and, you know, have an appointment when, when people can come in, cos I appreciate people work and they’ve got families and all the rest of it. So, I guess it’s just trying to be as honest and upfront with people as early as possible.

And then they’ll have a conversation with the consultant as well as us, and yeh, we can go back and forwards as many times as they want really till they’re happy to take part, or not, whichever.

So meeting face-to-face is, is a really useful way of, of getting that process started.

Then when somebody has shown that they might be interested in hearing more I would go to visit them at home, and talk them, talk to them individually, away from the bustle and noise of the group, and talk to them individually about the specifics of the project. Exactly what it would entail, and I’d do that accompanying the consent form, so that they can read the consent form at the time, or they could follow it, but I’d read it aloud word for word so that they were getting the same written information as they were getting auditory information. And then I would pause and emphasise different bits as they go along. I would check and ask for questions. So, I’d use my kind of I’d monitor somebody’s facial expression or whatever, if they went, or you know where I’d check to say, You know, have you understood what that is? Do you, do you get that? And we’d talk about somebody’s specific situation.

And at that point I would say, Okay, so that’s the information, I’ve given them the opportunity to ask any questions, and so as I say I’d support any questions with a writing or reading or you know you can see I use gesticulation a lot, tone of voice changing re-wording things if they’re too complicated, using plain language, and then give them the time to think about it, and say when I’ll come back. If you’re happy for me to come back, so I would never do consent straightaway. There’s the time to think about it and you know be with others and if, if the person wants somebody else to be with them for that and to support them in that exercise then that’s great, we’re very happy for them to do that. But equally I feel very strongly that it’s important that it’s the person who’s taking part in the research, and critically it is the case that people with aphasia have capacity, to make these decisions but that the information needs to be delivered and presented to them in an accessible way.

Yeah.

So I think historically there might have been, it might have been easier to you know defer to a carer or a significant other, to explain things and to you know check that they’re alright with it, but my preference very much is to have the conversation directly with the person who’s got aphasia, and check that they understand it and then and then similarly with the consent form, I would, I wouldn’t just give it to them and let them read it, I’d say, Okay so what you’re agreeing to here, this says, are you happy with that? and then they can give a tick or whatever. And then even things like writing down their name at the end, on the bottom of the, on the consent form I would, if they’re not able to do it by themself I would write it down for them so that they could copy it, so there’s layers of different little support things. But that’s very much drawing on my clinical experience to do that.

There is quite a lot of pressure to get patients into studies. I mean obviously, if you kind of decide on a target at the beginning, I mean I think just personally you quite like to do what you said you’re gonna do, so that’s one thing. But you do get, I mean there is a certain amount of pressure to meet those targets anyway. I think we, I would say mostly when we get patients on studies in [City] we do generally keep them on the study, we do have quite a good record of sort of, once people are on it, they stay on it. But then we do sometimes struggle to recruit, but then I think perhaps because we’re not pushing people that perhaps aren’t necessarily appropriate for the study, then we’re getting the right people, and then they are staying on the study throughout. But I think, I mean I think that’s one of the hardest things in research is recruiting [laugh] people, recruiting people to studies because you don’t want, you don’t want to persuade people to do something, you know. You, I think especially as a nurse, you want to be an advocate for that person and, you know, if someone has got reservations about it then you don’t want to, you know, you don’t want to push them to do something that isn’t really right for them [cough] for whatever reason. So it’s sort of finding a balance between sort of, you know, trying to sort of be positive about the study but equally not, not forcing people to do something they don’t want to do.

Just another little thing that we do as well is we don’t just sort of come in and, you know, see patients and say, you know, I’m, I’m part of the research team, what we always say is I work with your consultant and he or she has asked me to come and see you today. And that’s made quite a big difference because we had a study several years ago now where we just went up and saw patients and we were getting quite a, quite a high, patients were declining and then we changed our tack a little bit and then we started saying oh, you know, Your consultant, Dr A, has asked us to come and see you today, and straight away you’ve got that, Oh, okay, is that, alright, okay, and then, you know, and it was an observational study but recruitment increased [laugh] significantly just because, because of that.

And that in essence is the art of being a research nurse. It’s not all science because you know on paper this person might have a performance score of zero, they might have good social support, and they might feel physically not too bad, but if after three weeks of a clinical trial they’re exhausted and, you know, they might have bad venous access and their arms are getting really sore from repeated cannulations, and they don’t want a PICC [Peripherally Inserted Central Catheter] line. Then you have to decide well actually it’s probably not appropriate because this is affecting your quality of life.

And I think as a nurse no matter where you are, no matter what ward you’re on, or whether you’re a research nurse or a nurse, you are primarily the patient’s advocate, you are there to look at the psycho-social holistic care, How are you managing with life? And if that’s becoming compromised it’s your job, I feel, to bring up that conversation of, How is your quality of life? Is this something you want to continue?

So obviously a core part of our role is actually taking informed consent for patients to go into a study. As I say, a lot of our studies are defined as low risk observational studies, so we do actually take consent and we use Band 5 nurses and Band 6 nurses to do that. And a core thing of what we teach them is about the fact that you, obviously giving them the information in the form of the participant information sheet but it’s also about you conveying in the language that when you speak to them that this something they can choose to do. And it’s about recognising when a family looks like they’re struggling to make that decision, and I think it’s whether or not they might need you to come and talk to their parents, so grandparents. And okay, we don’t need to take an informed consent from a grandparent but actually if a parent feels that they want you to explain it to other people, then that’s what we would do. So we want to help them, we want to facilitate them making that decision, and if that’s involving speaking to other people, then actually we can do that.

If it’s, it may be speaking to the child and young person ourselves as well, obviously sadly when they’re on intensive care a lot of our patients are already sedated, so it’s hard to involve them. But we do actually consent for some studies, almost pre-operatively before they come to the unit, so where possible we try and speak to the child or young person as well. So I think it’s about seeing what the family need and trying to meet that. If it’s that they’re concerned and they want to see that you’ve spoken to their cardiac surgeon or their nurse specialist, then we can facilitate that as well. But also recognising that there’s no-, there’s no pressure and it’s absolutely their right to withdraw or, you know, to not even take part in the first place, that they don’t have to take part. And that it will not affect their clinical management otherwise.

The emergency one, that was always them [doctors taking consent from patients]. I was, you know, it was too much of , it was a CTIMP [Clinical Trial of an Investigational Medicinal Product] and, you know, quite an important one – you could kill somebody with it. So that was always them, I was just there helping. So for that one, I would be doing-, you know, what it’s like, the doctor explains to the patient and then they go away and the patient says, What do they mean?

So I’d be doing that bit, which I was used to [laughs] as a nurse. Doing a simple explanation. And paperwork. And that sort of thing. And I also helped administer the drug. Because I’d come from an area-, you worked in chemotherapy and I was used to working with drugs, and. And things like that. And the ward staff actually, it was quite new, thrombolysis, then. And the ward staff were quite- a lot of them were quite under-confident about it, so I brought my previous nursing skills to that. I was more confident in a way.

And then the other trial, the one that was acute but not emergency, you could- that was a CTIMP [Clinical Trial of an Investigation Medicinal Product] but they allowed nurse consent. So for that one then, yeah. Within a few weeks I was probably recruiting. And the other one was just to do with a medical device, but not a drug.