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Rachel - Interview 24

Age at interview: 35
Brief Outline: Rachel consented for her three children to take part in a Swine Flu Vaccine Trial earlier in 2010. Her interest in Clinical Trials was a primary motive for taking part.
Background: Rachel is 35 years of age, White British, and lives with her husband and their three children aged three, five and seven years. Rachel works part time as a Research Fellow and trial manager for a Clinical Trial.

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 Rachel is 35 years of age and lives with her husband and their three children, ages three, five and seven years. Rachel is a part time trial manager and a Research Fellow. The initial invitation came as part of a mail shot looking for young children to take part in a Swine Flu Vaccine Trial. 

Rachel explains her reason for consenting for her children to take part' “One, I was interested in clinical trials anyway, because it’s what I do. So I thought ‘I’ve got to give something back at some point’. And “Well, I can actually help with this one.”
 
Rachel and her husband initially checked the literature and trials that had been done on these particular vaccines before going ahead. Rachel explains' “I felt quite confident that there was nothing harmful in those vaccines, and it really just was a comparison study between the two vaccines to see which, which would be the most effective. So that was my primary motivation. The secondary motivation was that I felt good that they had got the vaccine earlier than anyone else. But I think it; that was quite secondary”. She later continues by saying “I wasn’t anti vaccines at that point, but I wasn’t particularly pro the swine flu vaccine either, and wasn’t sure how necessary I felt it was”. 
 
Although the trial was randomised, there were just two vaccines being used, and children were randomised to receive one or the other vaccine. At that point, they knew which of the vaccines the children were going to receive. 
The trial involved three visits to a local hospital that involved blood tests and the vaccine injections. The first visit she explains involved quite a long in-depth interview explaining the pros and cons and making sure that she fully understood and signing the consent form. She said that the blood tests were the hardest part for the children and only one of her children managed to have the final blood test. However, as there were other means of testing whether the vaccine had been successful this was fine.
 
Each of the children received a monetary reward at the final visit, which was unexpected. However, Rachel felt that providing monetary incentives is probably not a good idea, although travel and extra costs are acceptable. Overall Rachel felt that the trial was well organised. Although there was a dissemination day organised for participants, Rachel was unable to attend this and has received no other information regarding the final results of the study. This is something Rachel feels is important and would have liked to receive a summary about what the final conclusions were, and which vaccine was proved to be more effective.
 
 

How you communicate with children has to be tailored to each child’s needs, especially when blood...

How you communicate with children has to be tailored to each child’s needs, especially when blood...

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 I think you have to be so individual to the child, the age of the child and also their experiences of what, other experiences they’ve had of hospitals and of vaccines or jabs or whatever. So I think the skill is to be able to tailor what you’re saying to that child and to see what they need. I don’t think there’s a right way for every child. I mean I know my eldest, a long time ago he’d been in hospital, and the nurse there had a lovely description of the, catheters the wrong word entirely, cannula. And she was just saying, “It’s like a straw that we put medicine in.” And he, that was brilliant for him. But I don’t know whether that would have helped any other child. You know, another child might have got frightened about a straw being put into his arm. So it was, I think you just have to be very individual in what you say and have lots of, you know, potential things that you can say.

 

If Rachel’s children want to take part in a clinical trial, she will support them and ensure they...

If Rachel’s children want to take part in a clinical trial, she will support them and ensure they...

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 If they wanted to take part in something that I didn’t want them to take part in, I would have to just find out as much as I could about it. But I mean ultimately it would be their choice. But if I felt I knew something that they weren’t aware of, I think I would present the case, scientific as possible a manner, and just explain to them what I was unhappy with and perhaps explain the consequences of that to them. But ultimately it’s their choice.

 

Helping medical science was a good reason for Rachel to enrol her children in a swine flu vaccine...

Helping medical science was a good reason for Rachel to enrol her children in a swine flu vaccine...

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 Well, it was the swine flu vaccine study, I would guess, rather than trial that was happening last year and the beginning of this year. So I just got a letter through the post because my youngest child had been born within the last two years, I think it was, or, I don’t know, whatever the criteria were. And then they also said that older siblings could take part as well. So we just thought; there were two reasons. One, I was interested in clinical trials anyway, because it’s what I do. So I thought, “I’ve got to give something back at some point.” And secondly I just thought that it would be, I wasn’t, actually I wasn’t particularly, “Yes, I really wanted him to have a swine flu vaccine.” It wasn’t something I really wanted. So it was more about the fact that they were looking for people to take part in, in the study comparing two different vaccines. So it was just really about, “Well, I can actually help with this one.”

 

Randomsiation is a bit like ‘flipping a coin’, but it is an important part of the scientific...

Randomsiation is a bit like ‘flipping a coin’, but it is an important part of the scientific...

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 But I would see it as being; I think it depends totally on what the trial is because obviously if it’s randomised then there’s always the element of chance. You never know which particular arm you’re going to be in. And it’s important everyone who’s, joins that trial is as equal as possible and as balanced as possible, so that differences can be determined from the treatments or whatever it is that’s being investigated. Yes, it was randomised, but it was just two vaccines that were being used. So it was which vaccine the child got basically. 

 
We did know which one we got actually. Yes, it wasn’t blinded. So I did know. But, yes, I knew I had no choice in which one it would be. 
 
And would it have mattered at all?
 
No, because I didn’t know anything about them. I quite liked the fact that the children had different ones. The two of them had the same, and one of them didn’t. I thought that was quite interesting to see. And I had a very slight inclination towards one or the other, but there wasn’t any logical reason for that. I have no idea why. I just remember the Baxter one, not being quite so keen on that one. But I have no reason why. I think it was probably something in the literature had possibly hinted that there was usually a, less of a reaction for the other one. I can’t even remember what it’s called.
 
I think really it just; a trial is just a way of being very scientific about something. So it’s not about looking at hunches or perhaps a couple of people do one thing. I mean we’re all very prone to think because we know one person that this has happened to, that that’s, that’s what happens. And that’s not what happens. In order to, in order to make a recommendation as to what people should do, we have to have good evidence to, to say, “Well, this is what people do. This is what the average person does.” And we can only do that in an unbiased way by using trial data. And part of that is that the two different groups of people have no other differences between them, other than one was randomised to something and one was randomised to something else. So I think the fact that you’ve got a group of people who are all starting off in the same place, and as large a group of people as possible, is really important. And that randomisation is just like flipping a coin really. You have no choice in it. It’s just one thing or the other. And that’s, the most important part of the trial is that there is no choice. If there was a choice, it wouldn’t be a randomised trial. So you might as well be going on hunches again. It’s because people have different views, and different people may have different views about one thing and choose something over something else, so.
 
 

Rachel gave consent for her three children to take part in a swine flu vaccine trial. However, if...

Rachel gave consent for her three children to take part in a swine flu vaccine trial. However, if...

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 Would there have been any reason for you not to have taken part?

 
There would have been. I’m trying to remember exactly what I went through. I was concerned at the stage, at the level of the trial. It wouldn’t have meant I wouldn’t have taken part, but I wasn’t sure at what sort of phase of trial it was. So I wasn’t sure whether the vaccine had been tested before at all. If it hadn’t, it would have been a very different decision. It would have been something I’d have thought a lot harder about and I don’t know what I would have done. I might have done, I might not have done. But it, given that it had already been tested and had already been licensed for use with children, I didn’t feel that worried about it. The only other reservation I’d have is that I wasn’t even sure I was going to give them the swine flu vaccine anyway, because it had been discussed and talked about a lot. So I had originally said I wouldn’t need to sort of take them to have a swine flu vaccine. So that, I did think about that and I sort of did a bit of literature searching on vaccines. But I think you just get lots and lots of scare stories around the websites. So I just thought, “Oh, no, I can’t be doing with that, so”. There’s very little objective viewpoints on vaccines.
 
 

Having blood samples was the worst bit for Rachel’s children.

Having blood samples was the worst bit for Rachel’s children.

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 And then they had a blood test, well, blood taken, which was the worst part of the whole thing. So they all had, well, I don’t think they managed to get blood from all of them actually. Certainly the second time we didn’t. I really can’t remember. I don’t think we got blood from one or, no, from two of them we didn’t. The eldest two didn’t give blood. The youngest one did, under duress. And then the randomisation happened, and that was just like a blinded, an envelope really. So they just picked envelopes according to allocation numbers, and then the vaccine was given. And then we were shown how to do the diary cards. So for the next two weeks we were taking daily temperatures and checking the site of the injection to see if there was any redness or swelling and just any other sickness, diarrhea, any other kind of illness really. And then two weeks, I think it was, might have been a week actually, but anyway a period of time later we then went back and they just had the second dose of the vaccine. So that was a lot quicker obviously. And then again we went away for a week, two weeks, whatever it was, and daily temperature monitoring again and looking at the site of the injection. And then at the final visit, they went back and they had blood taken again, just to sort of look at the antibody response. And that was it then. Yes, yes, that was the end.

 
And, because that’s what other parents have said, that the, the giving blood was the, the bit that the children didn’t like.
 
Yes, no, they didn’t at all. I mean they didn’t like the injections, but they were so fast that they don’t really know. Yes, but actually giving blood was, was hard for them. It was hard for all of them. My eldest, he, because he was, he was very pleased about taking part in the trial. For him it was kind of a big thing because we’d said to him, “You’re help, you’re helping other people. And you’re going to be one of the first people in the country to get the swine flu vaccine as a child.” And he, he really was proud of that fact. And he really wanted to give blood the second time, you know, final time. Because we were saying, you know, “That’s part, that will help.” And he was very worried about whether he’d get his sticker if he didn’t and all of these kinds of things. And he got himself in a complete state about it and wouldn’t do it, couldn’t do it. Just, for about half an hour they were trying. And he just got so upset about it and sort of walked out and couldn’t do it anymore. And he then had a chat to Daddy and in the end he kind of came in all brave and did it. And he was incredibly proud of himself for doing it. So he did manage it, but I don’t think, I think it was the other two then that we never got blood from that time.
 
And how did you feel about that, when they, you were seeing that? Did that bother you at all? Did you have reservations at any of, any of that?
 
It’s kind of mixed really. Because initially, actually I do remember feeling, the first time we did it, so when they were originally taking the first blood sample, I got the impression that if they didn’t give blood they wouldn’t be able to take part in the trial. And I did want them to. So actually I was a bit upset that they didn’t get blood out of one of them, or two. I can’t, I really can’t remember what it was now. But I initially thought that meant they couldn’t take part. So I was worried at that point. But when they then said, “No, no, it’s fine. They can still do it, because we use other measures as well” I thought, “Oh, that’s okay then.” So the second time round, when they were doing it the final time, I was concerned for Evan, my eldest, because I didn’t want him to be too hung up about it and I didn’t want him to become phobic about it. So I was glad he did it. But the others I wasn’t really too bothered about really. I thought it would just; I didn’t want to, I didn’t feel it was worth upsetting them about it really. It wasn’t that important.
 

Although it was fun at first, Rachel’s children tired of having their temperature taken every day.

Although it was fun at first, Rachel’s children tired of having their temperature taken every day.

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 And when you say they enjoyed it, it, was it the, the bits they had to do at home or just the whole?

 
It was the whole process. It was the idea that there was something special about what they were doing, that they were helping people and that they were the first people. Evan was very, particularly very pleased about being the first person, in the country as far as he was concerned, to have the swine flu vaccine. So he was pleased with that. And the younger one, he was almost five at the time, he, the certificates worked fantastically well for him. He was very, very pleased with his certificate. Very worried he wouldn’t get it, and, and that was a big thing. And they, they liked the little plastic envelopes that all their things came in as well. So the daily monitoring that we did, they all had a plastic envelope with a ruler and a thermometer, and that was, for them that was great. So having something that belonged to them for the period of that trial and bringing it back in, they, they definitely liked that.
 
So that was good then? [Yes.] And was it much, was it, when you say it took ten minutes, was it very demanding of the time in what you had to do at home?
 
It wasn’t very demanding, but it was demanding, to be honest. It, it was a bit of a hassle, but it wasn’t a terrible hassle. It was just something to remember. And by the end of it they were all getting really fed up of having a temperature taken. And the youngest, Barnaby, he was, he was 2½ at the time. So it was a real struggle to get him to sit still. He wouldn’t sit still. So we were literally having to hold on to him to try and get his temperature. I think it was just because it took so long. But it was a bit annoying.
 
 

Apart from the blood tests, Rachel’s children enjoyed taking part in a swine flu vaccine trial.

Apart from the blood tests, Rachel’s children enjoyed taking part in a swine flu vaccine trial.

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 Well, I don’t think so really, other than to say that the, the monitoring side of things was actually very interesting. So doing the daily thermometer checks and, and the children actually really got into that, and it was almost like a competition who had what number. And, and they liked that part of it. 

 
But no, advice to a parent; just really that its fine. In, in that particular trial they were licensed drugs. There was no added risk than any other vaccines. I mean there is a risk because it’s a vaccine and there’s a risk with any vaccines, a risk with any hospital trip. It doesn’t matter. So it would be just to make sure that you really wanted to do it. I think I would probably warn them that they would be taking blood a couple of times. So that would be something to consider, that, if some parents really don’t want that. That was, it was part of the trial that you had to try to take the blood. That was the element where it came in. That’s where I got confused. So they would have to at least be consenting to say, “We will try.” So I think I’d just make it clear that that was a process they had to go through. But I think other than that it would just be reassurance really. I find it hard to reassure people on trials, because it’s what I do. So I feel very much like I don’t want to coerce anyone in, to push them. But for me trials are fine. And I think I’d just explain to them that actually we found it really interesting, and the older two really enjoyed taking part and were really very proud of taking part.
 
 

Taking part in other trials would depend on the benefit for Rachel's children and the benefit to...

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 It would depend what the trial was for as well. So it’s not just the level of risk. It would be risk-benefit really. So it would be whatever benefit, and not, I don’t just mean that to my child, but I mean sort of society benefit as well, what the overall benefit would be. Obviously the level of risk is relevant as well. And again I think it would just depend so much on what the trial was and what it was for. 

 

The information was all available on a website. Rachel was happy with this and her background in...

The information was all available on a website. Rachel was happy with this and her background in...

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 And when you were kind of accepted to take part, then did you get further information?

 
Yes, well, no, actually. I did, but it was only via the website, because it was quite a, it was a trial that happened very quickly, because they were obviously in a position where they were hoping to actually roll it out across the country. So the whole thing happened within a couple of months really, which as you’ll know is, is very unusual for a trial. So the patient information sheets were all on the website. So it was, there was a web link directing you to go and read all of it, and then if you were interested to sort of put your email and contact details down. And once we actually went for the initial interview, where they, they had their first vaccine, as well at that point, there was a long in-depth interview sort of explaining the pros and cons and just making sure that I fully understood.
 
And how did you find that, having to go to the website to find information about the trial?
 
It was absolutely fine for me. I mean I’m very au fait with that information, those trials and the kind of questions that you need to ask. I mean I looked on the RCTN [International Standards Randomised Controlled Trial Numbers], like I never can remember those acronyms, but the, the unique randomised numbers, so I looked at that information too. And so for me I found it very easy, but I don’t know if, but I was just, I knew a lot about it anyway. I knew where to look.
 
 

Receiving payment to take part in a trial seemed unethical to Rachel, although it should be made...

Receiving payment to take part in a trial seemed unethical to Rachel, although it should be made...

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I think I’d be very split. There’s a big part of me that says, “No” that you shouldn’t be giving any sort of coercion to take part in a trial. And then there’s another part of me which is the researcher saying, “But we need participants. So if that encourages participants”. But, no, I think ultimately, I think it’s unethical to provide any form of payment. So I think it has to be on a subsistence type. I don’t think it would be appropriate to ask somebody to volunteer because they think they’re getting money from it. So, so no, that’s the bit that wins. It would be, “No, I don’t.” I think its fine to provide, I think its fine to make it as easy as possible for someone to be able to take part. And if getting childcare, for example, or buses or taxis enables them to do that, then, yes, I think that’s a good idea. But I think they should just be having costs covered rather than being given payment. 

 

Rachel was unable to attend the dissemination day and since then has not been able to locate the...

Rachel was unable to attend the dissemination day and since then has not been able to locate the...

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 The information I got afterwards, I would have preferred to have a bit more. We were invited to a dissemination day but unfortunately I couldn’t attend. But I haven’t had any feedback on the results. And I keep looking and I’m actually struggling to find it. Although I found the University website very well, it, I do remember it being quite obscure. And I’ve lost the paper and I can’t Google it. I’ve been looking for the, the trial results and I still haven’t found them. So that would be one thing that I would say. I would have preferred to have had a, actually sent a summary information about what their final conclusion was and which vaccine they’re actually using, were using. I don’t know if they still are.

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