You have no control over that. You know, as far as I was, I think it’s a computer isn’t it that does it. And so there you go; the decision is made for you. You just make the decision on whether or not you’re going to be happy with the outcome. So almost the outcome has to be irrelevant, because you’ve got to be able to sit with whatever the outcome is. And I think that’s what you need to focus on. How do I feel if it’s a weight-related dose or, you know, How, how do I fee And I think providing you’re okay with that, then it’s

So did they mention any sort of being in a group, you know, whether you’d be chosen to be in one group or another group? Did they mention that? Do you remember?

I’m not sure, see, I’m not too sure. I do remember groups but I don’t know if it was like putting like us there and them there, if you know what I mean. See, you did have, you did have groups, yes. I think it might have been. I’m not too sure.

It might have been a control

That’s the control group, yes, I did. That, that rings a bell but, as I say, it’s been that long, it’s sort of… The only things that stick in your head is everything else what I’ve got to do for my son. And that’s the, like the, try to keep on top of his needles, his finger strips, his insulin, making sure I’ve got everything and like not, it never runs out and everything’s like still in date because you’re only allowed it out the fridge for three, I think it’s three months and then obviously it’s no good after that. So you do have to make sure you’re on top of everything.

So it’s, more important is his care?

Well, yes, because you’re concentrating, see, anything else, you’re concentrating more on that. So it sort of, it sort of sticks in the back of your head, but it’s obviously, it’s, unless you read it or someone tells you, it won’t pop up into your head because you’re focused on the one thing. And, which is the main thing, which is obviously his care, to make sure everything’s all right for him.

And would it matter, did it matter to you that if you were in the control group and weren’t in the intervention, does that, did that make a difference in the decision at all?

Well, to be honest, I’d have to say no, because everything that, like everything that’s gone on I’ve, I’ve thought was spot on. it’s helped me; it’s really helped me a lot. So I couldn’t, I couldn’t say nothing bad about it. Every, everything to me is brilliant. Because, you know, he’s, I think my son’s been diagnosed now for two, two and a half years, and I haven’t had a problem on that in two and a half years. So to me that’s, that’s good. And it’s really, it’s really helped like. Personally I was scared at first at, like about learning of, you know, it’s a lot for you to take in. And then you’re giving him injections, doing his finger pricks, all stuff like that, and his food. But, to be honest, I didn’t think I’d be able to do it. And I did. It, they really did help. See, it, I, like obviously when he first got diagnosed and we were still in the hospital, that’s when you’re thinking, Oh, I have to go home and do this But obviously they show you there first before you go home. And, to be honest, when they showed me I didn’t have a problem then about going home. it’s just at first I was thinking about it, going, I’m going to have to take him home and do this. He’s going to be doing this forever But that’s before obviously I learnt it in there. And it, to be honest, it was brilliant. Like it all, it all helped me and I’ve had, I haven’t had a problem. So to me, they done good for me. They done brilliant.

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.

Did they talk about all the randomisation and that and things like that?

Oh, yes, yes, yes, they did.

And what did you, what do you understand about that?

It was just basically that there’s different ways to treat it, and there’s no right way to treat. So if they can treat different people in different ways and then they can find out which is the happy medium. And, fingers crossed, they can use the one treatment for everybody. And hopefully they’ll find the right solution to it.

Did they explain that she might be in one group or another group and how that would work?

Yes, yes.

How did they explain that to you?

They just said that there was a couple of ways of treating it and they just randomly pick one. And, fingers crossed, it’ll work for Emily. And if it doesn’t, they’ll try something else.

And did you mind that, being randomised in to –?

No, no, because at the end of the day whatever treatment they try, it’s all trial and error, with any illness. You can’t say, Right, this treatment will suit you and that treatment will suit that person It doesn’t always work that way. it’s all hit and miss.

What do those terms mean to you?What does randomisation mean to you, if you had to explain it, to another parent?

Pot luck. You just, you just, you just go, just go with the flow. At the end of the day if they randomly pick a treatment for you. All right, it might not be the best treatment for you. And they can change it. But it’s best if it gets, everything is trial and error.

With the growth hormones they have different dosage they give different children, and different strengths which they get on and then they look at which children have done differently on the strengths.

Did you know which strength you were on? What Callum was on?

We were told that he was on the highest strength because they had three different strengths and we just got told he was on the highest strength.

So you got, did you, did they talk about being randomised into?

I think they, like the first year he was on higher then the second year was something else, and then like the third year was I think like random. And he’s now gone on it because we’ve just re, because he’s done his three years, they’ve asked if we wanted to continue. So he’s now continuing and that’s to, the growth hormone to the level of what he’s missing, so he’s now on the dose which he is missing himself.

it’s just, I just usually say like the clinical trial bit is just like where they’re actually put, it’s a bit like number crunching, that they’re actually researching to find out more, to see what they can do to help other people and other children. So that they’re actually looking at each child, and then feeding in the information to see how they’ve developed, to see what they can do to make the medication and everything more effective overall to other people.

And if you’d have been put into a lower dose would, would you have minded? That would’ve been, you know, were you pleased to be in the higher dose, did it make a difference?

Well I thought the higher dose would have made a more difference, because for Callum being that he was so small, I thought the higher dose would give him a quicker boost to get him a bit bigger where he should be, and it has so,

But some parents might be on the lower dose?

And I suppose it all depends because with the children as well, they throughout, even if they are on whatever dose, a lower sort of thing, they’re always taking their growth hormone anyway. So, they do tweak within the dose limit’s as well because they have to be on a certain dosage to make it work so, I suppose even if you’re on the lower they would tweak with what your child, because if they’re not producing growth hormone they’ve got to have some to grow. So they wouldn’t be putting them on a dose which isn’t actually going to be any, not beneficial for them because whatever dose they are on it’s going to be beneficial. So they’re not going to give them doses what aren’t going to work.

The clinical trial that Matthew was part of was to test or prove the efficacy of these Ketogenic diets. There are two versions of the Ketogenic diet. There is the classical Ketogenic diet and there is the MCT version, which is the Medium Change Triglyceride diet which is where there, there are different types of fat given. So you’d have long-chain fats more for the classical diet, and then the medium chain. So with these two versions, they were testing which one was better because there was a lot of information out there. They were saying that maybe the MCT diet wasn’t as good.

Now in order to prove the efficacy of the diet overall they had a control group for three months. So when you went in on your initial appointment you were randomised, by a computer to either the control group or the diet group. So the control group would have to fill in all the forms, and do all the seizure diaries and everything else, but and they, no treatment would change for three months. And then eventually they would start either one of the diets, and they would be randomised to either the MCT or the classical. Now Matthew wasn’t randomised to the control group so he didn’t have to wait three months to start the diet. And he was randomised by the computer programme that did it. And he was randomised straight to the classical Ketogenic diet.

But the families that came along after that were going on the clinical trial; I think they had a more difficult time. They were like, they had to go through things in more detail, and some of them were very disappointed that they went to the control group. And I could understand that, because they’ve got children who are very sick with seizures, that are having a lot, and they don’t want to wait another three months. You know, they’ve got in their heads, It’s a new treatment we want to start it now. So that was frustrating for some. And it was kind of coaching them through that. I was quite lucky.

With some of the parents that were frustrated about going into the control group, that, I was quite fortunate because I was able to chat with them on the phone and go, Listen, this is important because this could affect the results, and this is why. You still will get the diet, but in the meantime prepare yourselves. Prepare, you know.

And I basically had written up everything that I did before the diet. What I felt useful, what I’d not, and that’s what I put on the site, and that’s what I sort of coached parents through. So I was I was luckier than most because I knew what it would entail.

Yeah because as you say some of the other families I spoke to, they were in the control. And then some weren’t happy with the version of the diet they got. That was the other problem. Because they’d read a lot of literature, or, or the book that had come out from the Americans who don’t use the MCT version of the diet, and only had had bad experiences of it with earlier trials where children had had stomach problems and this kind of thing. But actually when you look closely it was because too much of the MCT was being given, they were giving it in too high a percentage. Whereas part of the trial, they were starting it off at a much lower percentage so you weren’t getting as many problems. Well not nearly as many problems.

So some of them had this fixed idea that the classical diet was the best diet, and that’s the one they wanted. So when they got randomised to the MCT version, again some of them got quite disappointed and I have to admit when Matthew got randomised to the classical, I was of that mind set as well and I thought, Yes, I’ve got the classical, it’s the best one. It wasn’t necessarily the best one, but it was just the one we knew the most about that had been used in America a lot. And I have to say after three years on the classical diet I changed Matthew over to the MCT diet and it was a doddle. It was really easy to use and Matthew loved it and it wasn’t a problem at all. And now I very much advocate both diets. And the MCT one is great for older kids and teenagers because it actually allows far more carbohydrates because of the different fats that you give, and how it’s metabolised.

And I mean when we first agreed to do the trial, it, I mean I think the fact that it was all to do with information and it wasn’t to do with changing her treatment, her medicines or anything like that, it was just to do with information. And I guess as a result of that maybe we didn’t think about it as much as we might have done if it had been, you know, there’d have been more impact if it had been a change in treatment or sort of a new treatment that was coming out. But even so, I mean when they said that it would be a random selection as to whether we would get the new pack of information or the old pack of information, and we were actually selected for the old, for, for the old pack of information. So in actual fact nothing changed for us in the way that anything was happening with my daughter’s treatment or the information even that was given. I mean that was a bit disappointing because you always think if there’s something new coming along then it might be useful to see it. Because I guess if as a result of the trial it’s decided that’s not the best approach, then we’ll never see that. But then it’s not the best approach, is it? They’ve made that decision based on the research. So I think that’s fine. And, you know, initially when they said that we would get the standard information, then, you know, it was a bit, Oh, what a shame But it’s, I think it’s worked out fine. And we’ve not seen any differences. So, you know, there’s not been any impact from that point of view. And it has just been answering the, the questions on general everyday, day-day stuff really.

Was, did your daughter understand that, that bit, you know, that she wasn’t getting something?

Yes, yes, and I think, well, I think she was, yes, she was disappointed, yes. Because, well, I don’t know what I imagine the new information to be like or the new way of delivering it. I don’t know. But, you know, you expect it to be all singing and dancing.

What is the standard information, how do they

Well, I don’t know, because that’s what, we’ve already had it. I mean we go to an appointment and we basically just have a conversation with the consultant and the diabetic nurse about how things have been going, and they pass on any information that is new that they’ve discovered. For example, there was a new book which is all to do with carb counting, which the diabetic nurse told us about. And so it’s just like that really, just sort of in a conversation style.

I don’t know whether they explained it. But I think, well, my understanding is that obviously they’ve got to pick some people who will get the new pack of information, or the information in a new way, and there have got to be some who, who continue with it the existing way, obviously to view what the results of the outcome of the study are. And I think the researcher went away and did something on a computer and it came up with a, with a magic number and, Oh, right, you know, you’re going with therdquo; So I’m presuming that it was just a randomiser in that it just randomly chose whether we were going to be yes or no.

You were slightly disappointed that you didn’t get the –

Yes.

the new pack?