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Clinical trials: Parents’ experiences

Other types of medical research

Some parents enrolled their children in research studies that were not clinical trials. Sometimes research is undertaken to get a better understanding about children’s health or a health situation, rather than to test or compare treatments, drugs, or other types of care. Sometimes parents used the word ‘trial’ to describe other types of research. (See also ‘Why do we have clinical trials in children and young people’ for an explanation of the different types and stages of clinical trials.)
 
Steve has been taking part in a longitudinal study on respiratory conditions in children since his son’s birth; his son is now aged 12 years. His son has osteogenesis imperfect, but Steve says he doesn’t think this was the reason they were invited to take part. Every two years Steve completes a questionnaire asking about his son’s health, such as how many cold’s and cough’s he has had. Collecting information among large numbers of children helps to provide better information about children’s health over a period of time.
 

Steve was approached just after his son was born to take part in a research study, although they...

Steve was approached just after his son was born to take part in a research study, although they...

Age at interview: 49
Sex: Male
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 Just after he was born we received a letter from the hospital asking would we take part and it would just consist of filling out a survey questionnaire asking how his colds and coughs would be, if there was any other side effects from it and I said “Not a problem”. Anything to help. Last year at some stage we received notification through the school that it was going on to the next stage and it would be to see what allergies and if be multiple methods of seeing if there’s a reaction and the G.P.’s would be informed presumably if anything came up. 

 
Just that they were, they didn’t say how long it would be going on for, just that they were trying to get as much information as possible to see on people’s lifestyles. At the time I was a smoker and Sharon had never smoked but I was and they just wanted to see what could be done, if anything could be done to help them prevent or get a cure for colds and coughs in babies and young children.
 
Right and do you know why you were approached?
 
I don’t know if it was because I was a smoker and or Jhon was born with Osteogenesis. I’d like to think they were all contributing factors towards the case study. But no, nobody sat down, we haven’t met anybody from the study people, it’s all been done by letter form.
 
It’s always just been a letter. That’s interesting. And how often, did they say how often or how often do you have to take part or what’s involved?
 
Every couple of years they’ve sent a letter out with a questionnaire and from what I recall it’s no different than the first one we filled out.  He was ten, eleven, roughly that age that it was filled out the last time. And, there was a pre-paid envelope to send it back in.
 
 

The questionnaire seems to be the same each year. The questions are about our son’s health.

The questionnaire seems to be the same each year. The questions are about our son’s health.

Age at interview: 49
Sex: Male
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 I believe there’s always a comments section of which you can ask any questions that that you want, you know but it was only every two to three years that you filled the form out . So, when it comes through your door you think “Oh, it’s that time again” because you’ve forgotten that you’ve done it. But once you start ticking the boxes or writing any answers down you realise that its, for all you know they’ve just photocopied the form and crossed out your answers to see if you are putting the same answers in. There didn’t seem to be any difference in the questions and apart from the time that, when I gave up smoking I would say our answers have been the same all the way along.

 
Well, how often was he having a cough and a cold? Did he suffer for, what was the period of time like that he was suffering with this cough and cold, had we done anything different for maybe this cough and cold to come along? How, how long had he been off school. 
 
 

They have never thought about withdrawing because the information they give might be of benefit...

They have never thought about withdrawing because the information they give might be of benefit...

Age at interview: 49
Sex: Male
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 I mean have you ever thought of withdrawing from it at all?

The reason that never thought about withdrawing because I believe that whatever information we send in might be of benefit. It might be no use at all but without them having it, they’re the supposed experts, they’re the ones that have to decipher all the information and in my mind they know which bits are important where we don’t. But without us sending that information in, where do they go? Because if we all stopped sending it in then whatever information they have got is useless. And with everything changing on a daily basis, yet alone yearly, I considered stuff like that very important. It doesn’t cost me anything, maybe five minutes of my time that I can fill the paperwork out. So, in sod’s law says it’s going to be me who suffer because I’ve not filled the paperwork out than somebody else. [Right.] You know whether my information is relevant or not, it’s me who’s going to suffer because of the information they’ve not received. I see it that when you go to the hospital for whatever reason, when they’re asking for a history, if you don’t give them all the information they can’t treat you properly. And something that you don’t tell them could hurt you. It’s not going to hurt them. If they’ve not got it and if you’ve got no outwardly signs of a condition or anything then they can’t ask you a relevant question that could give them maybe he’s got this, so any information that I withhold I’m putting my life at risk, not theirs. And I enjoy living.
 
Steve says that the information has been a bit vague and he doesn’t know when the study is going to end and he hasn’t received any feedback. He says that providing feedback to people who participate in research is important and he would like more communication from the researchers about the study and its progress.
 

Because they haven’t had any communication or feedback from the researchers, except for the...

Because they haven’t had any communication or feedback from the researchers, except for the...

Age at interview: 49
Sex: Male
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 Only in the aspect of even at the start of these new studies sending the letter out every two to three years asking for you to fill out the same form again, that’s okay but maybe they should be sending a letter out sort of keeping you updated so that you’re not forgotten. Because as it was, we were getting these, this form every two to three years, you’d forgotten about it because apart from the five minutes it took to fill out and sign the form there is nothing, no information being brought forward, nothing to tell you when you receive the form of how things are progressing. So, and never actually having met anybody that I can recall. Because the amounts of different doctors and nurses that we’ve seen, some of them we’re on first names terms with because of how often we’re there for. So the person that asked us to take part. I don’t, I can’t recall them. You know there could have been one of the nurses or doctors that came in on ward rounds, for all I know they could have just sent us a letter because we, Jhon was born on a week that they’ve chosen and they’ve sort of okay we’ll send a letter out to everybody who has had a child this week. So we might not actually have met anybody. You know we could have just been fortunate that we were on in the hospital that week having a baby. So... remember the people that you’ve got on these trials, keep in touch, not saying go out for a cup of tea or a pint with them every week because the amount of people on you haven’t got time for your trials that way. But maybe every six months a letter, every twelve months a letter, just to keep you in the loop.

 
Oh, over like I said, it’s either four or five forms from what I recall it’s the same form. I’ve filled out four or five on Jhon’s lungs on how a cold and that has affected him over ten years. I would have thought by now there’d have been some information that they could have given us, maybe the forms change slightly. Because I don’t know what the date on these forms are because it’s not anything that’s occurred.
 
Recently Steve’s son, Jhon, has been asked to take part in the second stage of the study, which involves allergy testing. This was a surprise to both of them. However, they are willing to continue and contribute to advancing knowledge, helping research and children (hear Jhon’s story here.)
Sandra and her daughter, aged nine, were invited to take part in a study to improve knowledge and prognosis of juvenile dermatomyositis (JDM). JDM is a rare condition that affects children under the age of 18 and affects approximately two children per million. It is an autoimmune disease where the body’s own immune system attacks the body, skin, muscles, and internal organs. 
 

Juvenile dermatomyositis is a rare condition and the researchers need every child with the...

Juvenile dermatomyositis is a rare condition and the researchers need every child with the...

Age at interview: 46
Sex: Female
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I was approached because my daughter was such a severe case of juvenile dermatomyositis. And basically her CMAS (Childhood Myositis Assessment Scale) scores, which is a thing they do to test muscle strength, all sorts of different, you know, counting how long she could hold her head up and how long she could lift her arms up in the air, her feet off the floor and stuff like that, go on all fours and actually get down to the floor, pick up a, and get back up without touching anything, you know. And the score is up to 54. That’s the highest you could get. When [daughter] was recovering, and this was when she was recovering, she got a score of 4 out of 54. So she was a very bad case. So the CMAS score is part of the trial, to try and understand the different severity of juvenile dermatomyositis. And also the bloods as well to, to record, you know, like all the different levels, how it affects, you know, the inflammation in the body. So all that’s shown in the bloods. So they take the bloods and they’re sent to the study, but with no names. Everything is kept private.

So the trial that you were invited to, tell me about, about that, what, what the trial is and what, what the purpose is.
 
It’s the JDM (juvenile dermatomyositis) study and it’s basically to get records of children. Because it’s so rare they need really every child on board so that they can get a better understanding of the condition, because it’s so rare. So they like, you know, they want to do the, the muscle test and the blood test because they’re the two most important things with JDM. That’s the, obviously the abbreviation for it. I can actually find it.
 
They asked me, you know, would I be happy for them to use my daughter’s information? It would all be confidential. And I said, “Yes, fine” because anything that helps her. Because it’s only in recent years, if she had have been born a decade, a decade earlier, then I don’t think she’d have been here because, and it’s only, a lot of children died from it, and still do. Because obviously once it, it, depending on what, how it affects the body, if it attacks the heart and the lungs, then, you know, and also the swallow, because she started to choke and, you know, it can go into the lungs instead. And, you know, it’s a horrible, horrible nasty condition. It really is. It’s awful.

 

Sandra recalls being given lots of information to take home and read and had time to make a...

Sandra recalls being given lots of information to take home and read and had time to make a...

Age at interview: 46
Sex: Female
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They did give me some written information but I can’t remember exactly what it entailed. At the time it was, it was obviously a difficult time. But even when she was allowed home it was still, you know, I still had a disabled child to look after. Do you know what I mean? I also had my son as well, who was badly affected by what happened to my daughter, and still is now. He suffers from selective mutism and with, and separation anxiety he did at that time. And we think that all kind of stems around what happened to her. So it was a very difficult time. So I can’t remember exactly. But they did give me some information and basically explained it was to do with the, the blood tests and the CMAS score, what they call it.
 
Did you have to sign anything there and then or could you go away and read it?
 
I think I could go away and read it, and I think I did take the information home with me. But I was quite happy to sign it. Do you know what I mean? The hospital are absolutely fantastic and they told me it was all confidential. So I just, I just signed it basically. They just wanted to do it to help other children, and to me that’s a good thing because it’s such a bad illness.
 
I was going to say, what, what made you sort of decide to do it really?
 
To help future children with JDM, you know, they need all the help they can get. They really do. Even with all the expertise of the doctors, sometimes it’s not enough. So it’s a good thing. Anything they find out that can help, you know, is massive as far as I’m concerned. It’s such a good thing. So any way I could help, that’s, you know, what I wanted to do. And I’m sure any parent who’s had a child with JDM would do the same thing, you know. Because, as I say, it’s confidential anyway, isn’t it? So only good can come of it.

And did you, when you sort of signed up to take part, did you have any questions at all you wanted to ask or did ask
 
I didn’t, no. Because they just told me it was confidential and explained to me that, you know, it would help into research into JDM. I was, you know, I was happy with that. It’s a complicated subject, so I don’t really think that I could think of anything to ask. Do you know what I mean? I didn’t know; I know a lot more about JDM now than I did then, because I didn’t have a computer at the time. So, and I’m actually glad I didn’t, because if I’d have gone on there and read the stuff, I would have been awful, absolutely. Because the computer’s not always a good thing to have, the Internet, you know, in, in cases like that. And I’m so glad I didn’t have it. Because I actually managed to Google her symptoms, I, when I got a computer about two years later, and it come up with her condition. And I was just like, “Wow.” But you can Google headache and it’ll give you a brain tumour. So it’s not reliable. But it’s all the stuff you see on there about the condition; you know, how, the things it can do. Not nice.
 
So it can be quite frightening, can’t it the Internet?
 
Very frightening, yes, yes. I mean it was a frightening time anyway for, for all of us, you know. My daughter doesn’t even remember it. So I suppose in a way that’s a good thing, isn’t it? I certainly remember.
 
 
 

 

Sandra was keen to take part she says: “After everything we had been through with my daughter that was just a tiny little thing that wasn’t even on the scale to me. I just knew that I wanted to do it because obviously it’s research to help, and because it’s so rare, I thought her information might have been more important than a lot of other children’s because she was so severe”.
 

It is a 10 year study and Sandra and her daughter have been in the study for 6, but they would...

It is a 10 year study and Sandra and her daughter have been in the study for 6, but they would...

Age at interview: 46
Sex: Female
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But in terms of how her data is being used, would you want, do you want to know that…?
 
Well, I suppose it would be interesting to know, you know. And whether anything’s come of it as well. I mean I think it’s a ten-year study. So, I’m sure they said it was a ten-year study, so maybe, I mean we’re nearly six years on, maybe I will find out something in ten years. Whether the information helped in any way, and whether they actually discovered anything from the study. It would be nice to know. As a parent, you know, of a child who’s suffered from JDM, it would be nice to know if they actually got anything back from the study.
 
Nice for your daughter to know as well.
 
Yes, definitely.

John’s daughter received heart surgery when she was a baby and since then they have been taking part in a longitudinal study that requires periodic check-ups and the completion of a questionnaire. John is pleased to be taking part and helping other children as well as his daughter. He says that filling in a questionnaire and going for check-ups every couple of years doesn’t take much time.
 

John’s daughter is part of a research study that involves yearly monitoring of his daughter’s...

John’s daughter is part of a research study that involves yearly monitoring of his daughter’s...

Age at interview: 35
Sex: Male
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 I mean essentially the other main one really is the it’s been run out of [hospital], which is where she had the heart surgery when she [Ding] was born. That really is, apparently we signed up to that when she’d had the heart surgery but I can’t remember doing it. [Right] But that was quite a few years ago. Basically every, I think it’s every five years they ask us to go down to [the hospital]. Basically for her to have a MOT, just check her over completely, look at her progress to see essentially how children that have had that type of surgery progress, if there’s any long term side effects that that need to be monitored, made aware of, looked at etcetera.  So essentially just checking her progress, checking every aspect of her, they ask us a load of questions in terms of how she is, obviously again with Chloe with the global developmental delay side of things that causes its own string of questions. So we’ve only been back for that one once now, which was about eighteen months ago I think.

 
That’s an ongoing thing?
 
Yeah that that will be now, yeah for every sort of five years. They have an overall review of her to see how she’s doing and check on her heart so they do an ECG, they do a heart scan see how that is and that’s on top of obviously the cardiology appointments she has every, every six months. But again it’s no drama, it’s a day out of your life isn’t it, it’s not a day out of your life every five years it’s nothing, you know in the scheme of things and you know, thinking back to what we were, you know obviously we’ve had a lot more experience of hospitals and the processing in place and so forth since then. But think back nearly seven years ago when she was having that done, we were properly weepy parent by the bedside, you know, what, didn’t ask any questions, didn’t really get involved, it was just you know, emotion constantly and all the rest of it and I think you very quickly learn that you need to change from that.
 
Catherine took part in a survey that involved completing a questionnaire and a follow-up telephone interview asking about her son’s health before and after having an operation for a second hernia. This was a study Catherine was interested in and would be keen to know if it changes policy or practice within the hospital.
 

Catherine also took part in a survey asking parents for their views on whether babies experience...

Catherine also took part in a survey asking parents for their views on whether babies experience...

Age at interview: 27
Sex: Female
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 And you talked about a third study that you’d thought about.

Yeah when he had his hernias we went to the hospital for the second operation there’s this whole, this whole baffling thing he was really a completely different baby. He went from being a settled contented baby who slept a lot because he was premature; he just slept all the time to screaming non-stop for hours and hours and hours. And all the staff in the hospital kept saying he’s not in any pain, the hernia doesn’t cause any pain, or discomfort, and yet they were giving him codeine, paracetamol and he still shouldn’t have been born. So I was like this is all a bit contradictory. And on the last day just before we left a guy came and asked me to fill out a questionnaire. And again he had an information sheet and he was doing a research study, he called it a research study into the difference, the medical opinion being that hernias don’t cause any pain and patient and parent reports of, of the changes and because the consultant had said “Oh, I hear this story a lot” and you know and he, he just had a rating questionnaire, had it affected various aspects sleeping, feeding, things like that and on a scale of one to ten could I rate various things.
 
And then he phoned, I think he asked me about the first operation when I was in the hospital and then he phoned after the second operation about, about a month later and went through the questions again. And asked me if it, if I’d had the same response and I don’t know whether I gave the same response or not, so that would have been quite interesting [laughs]. [Yeah.] But that, that would be something I’d be interested to follow up on and I have still got the information sheet somewhere because it, it impacted on, on us quite significantly being told, told that he wasn’t in any pain and yet feeling that he really was so, yeah. I’d be interested to see if it changes any policies in hospitals.
 
Nikki and Chris’s daughter took part in a one-day research study. After their daughter had recently taken part in a screening trial they were more open to enrolling her in other studies. Although they agreed to take part, they can’t remember what the purpose of the study was and they haven’t had any feedback. However, it all seemed straight-forward and wasn’t invasive for their daughter, so they were willing to take part.
 

Chris and his daughter were invited to take part in a one-day research study at a clinic visit....

Chris and his daughter were invited to take part in a one-day research study at a clinic visit....

Age at interview: 38
Sex: Male
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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-to-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.
 

Last reviewed September 2018
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