Chris:We were actually approached by the original trial nurse who introduced me to another trial nurse, because it’s a specialist hospital so the place is positively buzzing with them. Which was a good move because Sarah was with me at the time and that meant that Sarah naturally relaxed to a degree because it was a familiar face. And then they explained to both of us what the trial was. And almost instantly I thought, I can see absolutely no harm in, in joining that trial. It’s a simple urine sample. And it’s, I don’t know if it is directly related to the original, but it’s in a very similar area. And again, as I said before, I personally, I was thinking selfishly, It’s just possible they’ll discover that Sarah’s levels drop very rapidly. She might need to have it balanced or . . . and so quite willingly and speed-, I think, I don’t know if I did phone you at home and say, — [You did, yes.] We’re going ahead with it. But we could see no reason not to.

Was that there, was that on the day, was it?

Chris:That was on the day. Because we were there and they said, you know, You can arrange to come in. And I said, Well, we’ve taken the, the medicine this morning and we have the time now to do it. So I’m quite happy to do it now rather than arrange another visit. Because as you can imagine we do quite a few hospital visits.

Nikki:And Sarah was quite happy to do it as well, wasn’t she?

Chris:Sarah was comfortable to do it. In fact she felt quite grown up, because it was, I’ll do that myself type of thing. It was, it was, she, you know, 10 minutes, this is done. Read the paperwork w-, they gave it to me there and then; I read the paperwork before we went anywhere to see what was involved. Then they chatted through what it was with us, with myself and Sarah. And I think I did phone you and have a 5 minute chat to say, I couldn’t see any possible reason not to. So we, we took part in that one. And it was completed from, from start to finish I would imagine the consultation and sample was all done within under, oh, under 50 minutes I would think.

So that was another quick, quick one really. [Yes.] And do you know have you had any feed, feedback from that one?

Chris:Again, again I couldn’t tell you anything that’s happened from that. Though I haven’t been, oh, no, I have been back to that clinic since, haven’t I?

Again I think they were then looking for known hydrocortisone users, so therefore they, and people who they could, you know, they could get a time and an amount. And they were also looking for people using high volumes of inhaled steroid. Because I think they both showed up in the urine sample they were looking at and they recorded both of them specifically, the amounts and the times beforehand. So I think again it was an ideal trawling ground in a severe asthma clinic. Quite a few children would be on the high steroid intake. And some of them would be like Sarah, would also be on a, hydrocortisone.

And did they explain, again did they explain everything to you? Was there written information?

Chris:There was written information, some of which I kept. Not only did I read but I was given.

Nikki:And they also sent us more after, didn’t they? A couple of days later we, we got an envelope with a lot more things in.

Chris: Like an information pack. [Yes.]

And again did it explain anything about different groups?

Chris: No there was no mention of the grouping or the

Nikki: No. Why you were chosen or anything.

Chris: It looked like, it looked from what I remember reading it as if it was a, very much a one-one trial on looking to see the variation in rates between individuals as opposed to But there was nothing to particularly explain that. That’s my assumption more from the fact that they didn’t mention that it was going to be done in any areas groups, age bands or, because they did, they did record individual age, the time you started to use these steroids, how long you’d been on them. That kind of information went with it. So exactly what pitch they were making within all that data I’m not really sure.

Nikki’ And I think the likes of, of this that you’re doing, it’s a, a, a lot softer than, you go on the Internet like we did and you look up something like adrenal insufficiency and you just get hard information, a lot worst-case scenario. Whereas something like this, where it’s, it’s real, it’s happened to somebody and you can sort of, Oh, yes, well, ours was like tha or, you know, or, Oh, it’s not, it’s not going to be so ba or, that, that would have helped us, wouldn’t it?

I think that’s just nice just what you said there, that it’s softer, and that that’s a nice way of putting it actually.

Nikki’ Yes, because it, information that you get on the Internet is, it is –

Chris’ Can be a little brutal.

Nikki’ Yes, it is hard, isn’t it? I know, you know, another one of ours has got asthma and they thought for a while he had cystic fibrosis. And in between them thinking that and them doing the test, I did go on the Internet. And it, it frightens you to death, you know, because it does seem to be all the time, O and, Worst cas and, you know, This could happe and, and that. Whereas if you, if you see people being interviewed and it’s real and they’ve come through the other side or you, you know, you’re reading a lot, a lot softer, I think it, it would, it would help a bit. Because you can’t help but go and look things up; if, if it’s there and especially if it’s about your child and health and things, you, you want to know.

Chris’ Not for those trials, no. In fact, no, for none of them was there anything mentioned. I have to say I’ve never pursued and wouldn’t have taken it had it been. And I think they’ve probably picked that up in the past that we weren’t in thatBecause it’s quite, that specialist hospital, because it deals with so many children and some of them are vastly worse condition than Sarah, I know they do have a system where you can go to, there’s like a cash office and they do give assistance. And it is notifiable around the hospital for parking and travel and things. So I think they’d be like, it, because it’s not a general hospital, I think they know it’s available if you choose to take it anyway. But we wouldn’t have bothered anyway, would we?

Nikki’ I think it, I think it would depend. I think we would get, gather all the information is what we tend to do [isn’t it?] and say, you know, What’s it about? Why, why are we doing it? How invasive is it And, you know, for the likes of Sarah you –

Chris’ What are the national and personal benefits? What’s the broad benefit and what’s our benefit?

And again we would talk to Sarah if it was about Sarah doing a trial. Because, you know, you’ve got to. You can’t just say, Yes, they’ll do i and they then get frightened or it’s something that they don’t want. Again we would gather all the information and then speak to Sarah and say, What do you think And, you know, and again if it’s invasive, well, how can you make that as pleasant as possible and, you know, not frightening or anything for the child?

Chris’ And I think if you were going to be involved in a trial that was more invasive, and there are some, you know, your child’s got an illness and they come up with a, you know, it’s invasive but we might find something ou I think then I would want, would probably really like to speak to somebody who’s been involved in something similar or look at something like this. It would really be a bit more relevant. Because we didn’t see, we knew she didn’t like her blood test, but we had both had them and seen her have them, so we both, we knew it was unpleasant but not major; something that could be dealt with even if it involved a little bit of upset. Whereas if it was more major than that and it easily could be, then I think we would have thought harder and looked into it more. Probably questioned where the results were going more and what the likely outcome was more than we did. Because in this case we saw it was a test for Sarah that gave us information and that, you know, the worst thing was going to be half an hour’s upset. Had that meant that she was going to be wearing something that was uncomfortable for weeks or taking any sort of medicine or drug, I think we would have spent longer and harder thinking about it.

Nikki:Yes, but as I say, the number from the nurse and then to the consultant that she referred us to, that, you know, that we’ve got mobile numbers, emails, everything. You know, they’ve been so approachable and nothing’s been any trouble. So, you know, we were phoning that nurse most days [weren’t we?] in between going to see the consultant and that. And, and she was great. It never felt like, you know, Oh, it’s them again. It was, Right, okay, what’s wrong? Even when we repeated questions or I’d found, you know, because she said, Don’t go on the Internet and, you know, looking at Wikipedia for adrenal insufficiency, because you’ll get terrified. But you can’t help it. You’re going to do that. You know, it, it’s like this site. If I’d have known that this site was there it would have helped us, wouldn’t it? Just to, to have that realism that somebody going through it and come out the other, the other end. Because you, you just, our world just went to pieces, didn’t it?

Chris:The continuity of the nurses from the beginning of the trial through to today, because it was that very same nurse that mentioned this process. So that, I think that, and once you’ve started again, she was in yet another trial the other day, when we went in the last time, which is to look at absorption rates from the inhaled steroid and, and deterioration from when you take it. And when we went in for one of her asthma reviews they actually took a urine sample and asked for the exact time of hydrocortisone medicine and measure and inhaled steroid time, quantity, and would they’d be looking at, for a tailing off graph, and we were trying to do that. But of course once you’ve started you tend to be more open to others, particularly if they’re what you might call non-invasive procedures, you’re more open, because you think it all helps to build a picture up.

And again Sarah knew the nurse, so she was happy that, you know, she’s helping more people now because she’s done this. And, as you say, it wasn’t invasive. It, you know, it’s over like that, isn’t it?

And, and how does it feel sort of consenting for your daughter to take part in something?

Because we, we understood it was for her benefit, you know, whatever the results would have come out, if it had come out and said that her immune system was fine, to us, to be able to have that sort of test done, was great because, you know, putting your mind at rest over your child is important. So not only are you saying, like consenting and giving her things and blood tests and that, but it’s, its means to an end, isn’t it? it’s not for nothing. It, you know, it’s helped her. it’s possibly helped other people. It, I’m all for that.

Nikki’ Sarah was diagnosed as being asthmatic when she was 18 months old, and at that point we then tried a whole range of preventer inhalers but none of them seemed to get her asthma under control. And when she was about three we switched to a, a drug called Seretide. And Sarah was on very high doses of Seretide and we did have concerns about her immune system and whether it would, it would impact on it or not. And then when she was about 5 we noticed that she was ill all the time. She was constantly ill. And we mentioned it at the hospital, this was in the, the December 2008, and, and we said we were quite concerned. But they seemed to think children get viruses all the time, so it was quite normal. But we, we made a note. There was two things. We made a note from the, the December to the March when she next went back to hospital of all the times that she was ill. And, and in that time she just, she had septic tonsillitis, three lots of conjunctivitis, two chest infections, a, a vomiting bug. She was just constantly ill. And we also noticed that she, whereas the, the other children or us would, might get one of the illnesses, she would have it for a longer period of time. And the other thing that we noticed was that she was, although one of the oldest children in a, like a pre-Brownies group that she went to, she was the smallest. And we’re quite tall, so that again concerned us. So when we went back to hospital and we put all this to them, the height thing was the thing that made alarm bells ring.

And so we were told that there was a, a clinical trial going on, which we had been asked to do the previous year. But, but Sarah had, had had blood tests done at the hospital a little bit before that. And because they were in a rush they didn’t put any Emla cream on her, and they, they just tried to get a vein and couldn’t get it and she was in a terrible state. So that in her head; blood test there was no way. So when it was explained to us that there would be a blood test involved, at that point Sarah refused point blank and we weren’t about to force her to do it. But when, when we mentioned the illness and the height, the hospital did advise that to put our mind at rest we could take part in a trial which would do two things. It would help out with the trial and it would put our mind at rest that she was just a normal girl having illnesses. So we were introduced to the nurse, who came out to the house first of all and sat with Sarah and explained exactly what the trial involved and that, Yes, it did involve a blood test after the three days, but that she would have her own Emla and so could put it all over her arms and her hands. And we had a trial with the Emla as well. When the nurse came out she showed us. She put it on her hand and her arm to let her see that she couldn’t feel anything, which put Sarah’s mind at rest.

And they said, you know, It is possible that the Seretide has had an effect, but unlikely. But they said by going on this trial it would put our minds at rest or, you know, or find out that she had something and be able to get it sorted, and it would also help with the trial. And at, at that point we thought it was, it was important to know because she was so very ill all the time and, as I say, the height thing did ring alarm bells with us, that we then were able to persuade her. And, as I say, the nurse came out and showed her with the Emla that it really wouldn’t hurt her.

And the nurse who came out was, was really lovely with her and explained it all and said, you know, If you’re not happy at any time or you change your mind, it doesn’t matter and, and you can just do that at any point. So she was a lot more willing to do it then. And, as I say, we were getting quite concerned as well, so we were probably a bit more not forceful but, but

Chris: Cajoling.

Nikki: – trying to sway her a little bit more in a positive… The last time it was just, It’s a trial and we’ve said no and it doesn’t matter. But we, we sort of wanted to know for our own minds as well whether the Seretide was having any sort of effect. Because, as I say, she was just constantly ill and they were major illnesses. You know, septic tonsillitis when you’re 5 is, or any age it’s awful, but when it’s just followed a chest infection and it follows something else, we wanted to know was this normal and, and she was just a normal child getting ill, or was there something we could do about it? And it has turned out that there was something we could do about it.

Well, we’d, we’d gone to the hospital for one of her routine visits with her consultant. And the clinical trial nurse came in and, and said to us that she would be a good candidate for going on this trial, could she get in touch with us afterwards? Which, we, we let her and she, you know, she phoned and she came out to the house and she went through everything. But, you see, the minute that she said it was a blood test, she just wouldn’t.

Well, that was exactly the same trial but, as I say, because Sarah had had such a bad experience with the blood test she absolutely refused to have another one. And we really couldn’t force her. Because she’d had a traumatic time having the, the blood test done at the hospital that in her head no way was this going to happen. And you can understand that. And at the time we, we weren’t as concerned as we became about her immune system. We didn’t realise what the drug that she was taking for her asthma could potentially do to her. We just noticed that her immune system was down a bit. But we had no idea that we were about to find out that she was so ill. So, so we got asked to go into the trial. And just, it was, you know, once it was explained to her, she just, No way am I having a blood test And so we just declined.

So later on it, you know, it, when we did the trial it was important because we, we wanted to know. And we could explain to her as well that, You’ve been so ill Because she, you know, this, was from the January to the March, and it was the March when we got asked to do it, You know, it, we might just find out something and be able to help you And because she had been so ill as well, I think she was a bit more receptive to, because she’d had enough, hadn’t she? You know, she, she kept saying, Why me? Why am I always ill? Why. And then, so we were able to say, Well, let’s see if we can find out And, and, and the nurse said that to her as well, didn’t she? So, so it was more, there were all positives for her at that point rather than all she focused on the time before was blood tests, I’m not having it

Nikki’ It was to put our minds at rest that there wasn’t a problem, with her being so ill and with her being very small, that, that there wasn’t something going on that we’d, we’d missed, which it turned out that there was, but, so that, that’s what made us. We, you know, we knew that she was too ill for there to be, for her to be okay and there to be nothing wrong. And it’s, you know, they were saying, Well, let’s put your mind at rest So it, it just seemed win-win all the way round. You know, we were going to be taking part in a trial which was going to help someone and we were going to get to find out if the drug had had any effect on her immune system. We had no idea that, that the drug could cause such damage.

I think because the trial was going on, I think they saw it as a way of, because, to be honest, her, her consultant didn’t think that there was, there was going to be any problem. It was about, I sort of felt a little bit like a neurotic mother. You know, All children get ill, you know As though you were, you were trying to say there was something unusual, but there wasn’t anything. Because the trial was going on, I think they saw it as a way to put my mind at rest but to have somebody take part in the trial. But, but nobody mentioned what they would have done.

Chris’ And the only effective way at the point to check out for cortisol, synacthen tests, is blood tests.

Nikki’ Is to do that test. So, so while you’ve got to do it anyway, why not be part of the trial? Which, you know, to us was just like, Yes, grea because we just wanted to know, Was she okay

It was, for three days she had to chew this cotton wool as soon as she woke up. And on the third day, that afternoon we went to the hospital and they did the, the test. And it was the following morning that we got the phone call to say, Come straight back and, and we’ve got medicine here for her

So that was that quick?

It was very quick, yes, yes. And it was only about, it was about ten days from that hospital visit where, you know, this had all come up to the start of the, the trial, doing the trial, which again was good for us because you just want to know. Once, once that question is, is raised, you want a test done, you want everything done quickly and the results quickly. [Speed.] Yes, because you’re worrying. You know, you, you’re worrying anyway, but as soon as they say, There is a possibilit you just want to know.

So those three days, was it very demanding of your time?

No, not really. [No.] A couple of meetings, which could have been quicker if we’d been in a rush, but we weren’t. And the test, the trial itself took sort of ten minutes each morning for three days.

Yes, and then, then in the hospital, we were in the hospital for, it’s about an hour and a bit, the test actually took; because they have to, they take the blood first of all and then they put the, the drug in. And then it’s over the, it’s three different times that they then, they leave the line in and then take blood at three different times, don’t they? I think it’s every 20 minutes, three lots. And then they take it all out and you go.

[Husband] Even after the, I can’t think, I didn’t know what the drug was that they injected, I can’t remember, even after they put that in she didn’t reach the base level they would have expected before the reactive drug.

She had the lowest test results that they’d, they’d ever seen. So it, so it was a good job that we, we did it.

I mean how did you feel going through the whole, I mean it’s just three days, it’s a short time, but it must have been like [forever]?

Well, to be honest, because everybody kept saying, it’s to put your mind at rest, mu I sort of thought, Maybe I am being a bit neurotic. But I just want to know So, so we weren’t, although we wanted the test done and, and everything, everyone that we spoke to was saying, Oh, it won’t be anything. It won’t come out as, as there being, there being any sort of problem. It will be fine. it’s just to put your mind at rest And that’s, that’s really what we wanted, wasn’t it? And, and I think again it came about because school, the school that she goes to are very, very strict on attendance. And she had terrible attendance and so we were getting these, these letters saying, You must take urgent action And I was going, Well, what do I do? She’s ill So really we wanted to know as well where to go next, because she was ill all the time. You know, whether, if the, we were thinking, If the test results come back and she’s fine, then do we need to give her vitamins? Do we need to do You know, that’s all we were thinking is, because everybody was saying, you know, you did sort of feel a bit like you were being neurotic. But you know, don’t you? You know your child and you know when something’s not right. As I say, especially having other kids we knew that, you know, if they got the chest infection that she h

And then the trial was, she had to, as soon as she got up of a morning, for three mornings, she had to chew cotton wool. And we put it in a bag and put it in, in the freezer in a special box, because the trial was about seeing if they could get levels of cortisol from children just chewing the cotton wool rather than doing a blood test. But in order to find that out they obviously have to do a blood test after the three days to see what the levels are. So we did that for three days. On the third day we took Sarah to the hospital, where she met the nurse and a lovely doctor as well who, who sat with her and chatted. And they had all sorts of games and books and things for her, to, to distract her. And they did, I think it’s called a synacthen test, a long syn…

Short?

or short synacthen test, where they, they put, put a line, they took blood from Sarah and they then put a drug into her. [Is that right?] Which is meant to, to get her adrenal glands going; which, which should, we were told that the numbers that they were looking for, they were saying when they did the initial blood test she should have a level of about 100 and when they put the drug in it should go up to over 500, and, and they, they tested this all the time That was on the, the Tuesday afternoon and they said again, This is just to put your mind at rest that there’s nothing wrong with her But first thing on the Wednesday morning we got a phone call to say that she actually had the lowest test results that they’d ever seen. Her results at any point didn’t get any higher than 50. Which, they were meant to get to over 500, 600. And so there was, we had to pick up medication for her urgently at the hospital because she, she was desperately low on cortisol and she wasn’t producing any herself. And that, at that point we then got referred to another lovely consultant who, who’s now looked after us all the time because she has got quite severe adrenal insufficiency. And, and so we’re, we’re on a learning curve now. But we were told that it was only thanks to doing that trial that we found out. Because her, basically her life was in danger and we had no idea until we’d done this trial what was wrong with her.

I can’t say it was explained. I mean the main drive that I think was given to us was the fact that it may save children having to have blood tests. If we can, if we can do it this way, you know, we can give a child a cotton bud to chew for two minutes, get that tested rather than a blood test, then that in itself, particularly with Sarah’s experience of blood tests, seemed good enough and persuasive enough for us to continue.

Nikki’ We had something, something to read and we also had, as I say, the nurse phoned us and went through everything. And then when she realised that we, we were going to go for it, she came out. She came out twice, didn’t she? The first time she came out and it was, it was just to show Sarah. She got all of the things out, you know, the boxes that we were going to use, the cotton wool, the Emla, all of that. She got it out and sat down on the floor with her and went through everything, and then chatted with us and explained what the trial was about and how important it was that they did this. Because it meant that hopefully in the future they wouldn’t have to do blood tests on children. They could just rely on this, on the chewing of the cotton wool.

Chris’ Saliva test.

Nikki’ Which obviously, you know, would if, if it would have been able to be done for us, was, was great. So, as I say, we, we were all for it. And then she, she came out again the day before we started the trial to make sure that we were happy, went through everything that we had to do. You know, explained to us about, you know, As soon as she gets up she’s to chew the cotton wool And Sarah was involved. It was, Then, then you put it in the bag. Then put it in the freezer and keep it safe for me. And bring it back in on the third day And, and she also worked out what would be the, the best time for us starting it, you know, with having other children and things. We had to make sure that, you know, we could get to the hospital when we needed to, which was on that third day. So she helped us to work out when to, when’s best to start it. And she really did go through everything with us.

Nikki’ She did and she was very down to earth. You know, she just came in, got on the floor and was like, Righ you know. And that’s what you want, that’s what kids want. They don’t want somebody white coat sat there that they feel they can’t talk to. You know, Sarah asked her questions and felt like she could. Which, which has, you know, helped her because she, she knew, and if she had any questions we’d say, Well, we’ll phone the, the nurs you know. Because she knew her first name, that’s what, you know, We’ll, we’ll phone her and put your mind at res or say, you know, She’s coming out today to see you And so she felt a bit special, that somebody’s coming to see her and it’s her special nurse.

Chris’ No, I think it; I don’t think we read anything that left us bemused.

Nikki’ No, it was very well explained.

Chris’ We understood the basis of what it was. And we did, I mean it very much was oral explanation alongside the written word.

Nikki’ Yes, because the nurse, came in with us to the, the consultant visit and, and she went through everything with us and then, as I say, she phoned us and she left us the literature and said, you know, I’ll phone in, in a couple of day and went through it again. So it’s, it’s, so the only thing that, that, that put us off, because we were quite open to do anything like that, was Sarah’s reaction, which –

Chris’ I can honestly say I don’t think there was any pressurisation or –

Nikki’ No, it, when we –

Chris’ It was very, We’ll leave the papers with you. I’ll phone in a few days and if you’re interested we’ll carry on

She did and she was very down to earth. You know, she just came in, got on the floor and was like, Righ you know. And that’s what you want, that’s what kids want. They don’t want somebody white coat sat there that they feel they can’t talk to. You know, Sarah asked her questions and felt like she could. Which, which has, you know, helped her because she, she knew, and if she had any questions we’d say, Well, we’ll phone the, the nurs you know. Because she knew her first name, that’s what, you know, We’ll, we’ll phone her and put your mind at res or say, you know, She’s coming out today to see you And so she felt a bit special, that somebody’s coming to see her and it’s her special nurse.

Makes them feel important?

Yes, yes.

And I think it’s good as well, it sounds like they can call them by their first name, but they also want somebody perhaps that’s confident

Yes, yes, exactly. With children, you can’t. You’ve, you’ve got to appear absolutely you know what you’re talking about. And she also, was good, this nurse, because she said to Sarah, You’re helping other children Now Sarah loved that, loves to think that, you know, she’s helped some children. Which is what she tells everybody, you know, My doing that has meant that I have helped hundreds of children which, it made her feel special when it was explained to her that what she was doing was important. You know, there was a reason for her doing it apart from us finding out about her. But she’s helped so many other people and, and she loved that aspect of it.