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Kate - Interview 13

Age at interview: 38
Brief Outline: Kate and her husband took part in a trial comparing injections of grass pollen antigen against a placebo as a way to reduce hay fever. Kate was in the experimental group and her husband in the placebo group.
Background: Kate is Operations Director for a charity. She is married with no children. Ethnic background/nationality' White New Zealander.

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Kate and her husband have bad hay fever. They saw an advert in a local paper seeking volunteers for a trial of immunotherapy for grass pollen allergy, and went along to see if they were eligible. Allergy tests showed they were both allergic to grass pollen, so they agreed to join the trial.

 

The trial involved regular fortnightly injections of either grass pollen antigen or a placebo for a few months each spring to summer for three years, as well as maintaining a diary of their symptoms and medication needed over the rest of the summer. It was explained to them that there was a small risk of going into anaphylactic shock after the injection, so they had to stay at the hospital for a while with a doctor nearby each time. It took a lot of time commitment and travelling to take part. Travel expenses were paid, and they were given free hay fever tablets, eye drops and nasal sprays as part of the trial. Kate was hoping they would benefit personally from the trial in terms of their own hay fever, but they also felt it was important to help others with hay fever by finding out is this treatment worked.

 

The trial was meant to be double blind – neither the trial staff nor the participants were meant to know whether they were getting the injection of antigen or the placebo. However, from her allergic reactions at the site of the injection it was quickly obvious to Kate that she was getting the antigen, while her husband had no reaction and they assumed he was getting the placebo. At the end of the trial, they were told they had guessed correctly, and her husband was offered a course of the antigen injections, which the trial had found did lead to a reduction in hay fever symptoms. Kate is disappointed that the injection has not since been made widely available on the NHS, but she understands it is quite an expensive thing to offer everyone and many people would find it too much of a commitment.

 

They were impressed by the research nurse who ran the trial, and liked the fact that it was him they saw every time. His willingness to share information with them and the relationship they built up helped motivate them to stay in the trial over the whole three years.

 

Kate has also recently taken part in an experimental study of a new type of surgery for a lump in her hip, femoro-acetabular surgery. This was not a randomised trial, but surgeons can only provide it if they take part in an audit run by the National Institute for Health and Clinical Excellence of how safe and effective the procedure is. For Kate, it was either a choice of taking part in this study or not having surgery. She likes exercise and wanted to improve her hip function so she took part and has been followed up. She is very happy with the results, but explains that in studies where patients and doctors choose a treatment rather than the treatment being decided by random allocation, there may be a bias in the type of people having the procedure. This means we cannot necessarily assume everyone in the population would get the same level of benefit.

 

 

 

Kate and her husband hoped a trial of grass pollen immunotherapy would improve their hay fever,...

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Kate and her husband hoped a trial of grass pollen immunotherapy would improve their hay fever,...

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I think my husband saw an advertisement in a local newspaper looking for volunteers to take part in a trial for hay fever, specifically looking for people who were allergic to grass pollen. He was very keen on this because he suffers quite badly from hay fever, and he suggested I get involved as well. I’m not quite as bad as him but it still has quite an effect every summer. So we contacted the hospital and went along for an interview.
 
One of the benefits of doing the trial was they provided us with hay fever drugs. This obviously saved us a lot of money. [laughs] We had pills, like Clarityn or whatever it was, and eyedrops and nasal inhalers as well. And so we just monitored whenever we felt we needed to use them to help alleviate the symptoms. The main reason I think we both got into it - we realised it was quite a big time commitment - was just the impact that having hay fever has. And the first thing is you think of yourself and you think, “Well, you know, if this thing does work, it’ll make my life a little bit easier for the next three summers.” And then the next thing you think of is of course if it’s proven to be effective and they release it widely, it could bring respite from the summer torture of hay fever for a lot of people. So that was the main reason for getting involved.
 

Kate advises people to think carefully about the commitment involved before they agree. If you...

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Kate advises people to think carefully about the commitment involved before they agree. If you...

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We were informed right from the beginning what commitment there was. We were told that we could pull out at any time, but obviously they wanted us to be sure at the outset that we were prepared to make the commitment, because it was better for the study if the people are involved the whole way through. And for us it meant travelling once every two weeks up to the hospital. And we’d usually go, I’d usually go after work and it would, including travelling, take nearly three hours every couple of weeks. And it was sort of from February through to May, and it was going every two weeks in that period, and then keeping a diary through the remainder of the summer. So it was a couple of months’ worth of commitment over the summer as well. And this went on for three years. The only payment we received was to cover our travel expenses.
 

What would you say to other people who might be thinking about whether to take part in a trial?

 

Be very sure of what the possible complications are and be satisfied you are not putting yourself at risk of serious harm. The main risk associated with the hay fever trial was anaphylactic shock but the risk was very small and precautions were in place in the unlikely event it did happen. The injection was purely grass pollen – a natural substance. If it was some kind of man-made chemical I would want to be very clear on the work that had previously been done with the drug and the precautions that were in place.
 
I would also say, make sure you understand exactly what the requirements are and what the time commitment is. If you’ve got any doubt in your mind about, “Oh, I might manage it for a year” but if it’s a long study, if you’ve got doubts, then speak to the person that’s running the trial about those doubts. Because really for the benefit of any clinical research, the more consistency they can have in the subjects that they’re studying throughout the trial period the better. So if you don’t think you can do it, I’d say pull out as close to the beginning as possible. But really, you know, it is such a benefit for these researchers to be able to carry out their work and to understand better what works, what doesn’t work, I really think it’s worthwhile. 
 

Occasionally Kate and her husband found keeping appointments 'a bit of a chore', especially when...

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Occasionally Kate and her husband found keeping appointments 'a bit of a chore', especially when...

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It wasn’t until we were underway, and I was clearly getting a local reaction and my husband wasn’t, that we thought, you know, that is quite a commitment to make and you’re not actually, well, he wasn’t getting any benefit from it. And they didn’t make it clear at the beginning that they would make the intervention available after, at the end of the trial, if it turned out you were on the placebo. So I think he did quite well to make the commitment the whole way through and follow through on it.
 
Did he ever think about dropping out? Or did you?
 
Occasionally it was a bit of a chore. But the nurse that was running the trial tried to be as flexible as he could be. And if something came up, and we absolutely couldn’t make it in one of the weeks, then he was able to let us come in the following week. I’m not sure what impact that would have on the results or anything like that. But clearly his clinical advisers thought that it was certainly worth, you know, being slightly flexible to keep us in the trial.
 

Kate and her husband guessed correctly that she was getting the active injection and he was...

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Kate and her husband guessed correctly that she was getting the active injection and he was...

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The theory was that your body would build up a natural resistance to the grass pollen. So they start off very low dosage and gradually increase the dosage of grass pollen in your system, until your body was able to fight the reaction by itself. For me, I definitely noticed an improvement in my symptoms. Although it was a double-blind randomised controlled trial, I think it’s called, so nobody knew who was getting what, I was pretty certain from the outset that I was getting injected with grass pollen because I was getting a local reaction to every injection. My husband wasn’t getting a reaction, so we kind of guessed that he probably wasn’t on the grass pollen injection. And at the end of the study, when they announced the results to us and told us whether we were or were not on the grass pollen and it was confirmed that he was on the placebo, they did offer for him to go through the process again, to receive grass pollen injections, go through the whole process but obviously without having to keep the diary, just so he could gain benefit. Because it was shown to be of benefit.
 
Did [the research nurse] ever say anything about your suspicions that you were on it and that your husband wasn’t on it?
 
I think it’s very difficult to sort of avoid it, because to me it was so obvious that I was receiving the grass pollen just because of the reaction I was getting. But he always said, “Of course I couldn’t possibly comment.” Sort of made a joke of it. But I think we both knew that I was clearly on it.
 

Kate took part in an experimental non-randomised study of a new type of hip surgery. It is only...

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Kate took part in an experimental non-randomised study of a new type of hip surgery. It is only...

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I ran the London Marathon in 2007 and either the repetitive motion of running created a lump on the neck of my femur which damaged the cartilage in the hip joint, or the lump was already there and it was the increase in running miles that led to the damage. The surgeon suggested that if I were a couch potato who wasn’t particularly active, then it probably wouldn’t bother me. But because I like to keep fit and do lots of exercise it was impacting quite heavily on my day-to-day-life. I wasn’t able to run any more. Cycling was awkward. And I commute by bike, so it was really having quite an effect. So they decided that they should look at the surgical options. And it wasn’t the same sort of situation where I was randomised to either receive the surgery or not receive the surgery. It’s a new way of doing an old surgical technique. They used to basically cut you open and dislocate your hip joint to get into the hip, to tidy up the mess of the cartilage. Instead they’ve started doing this by arthroscopy. So they make the three little incisions near the injury, and they insert a camera into one, and then the other two are used for inserting tools. And they basically watch what they’re doing on a TV screen. And so they were able to remove the lump that was there, and they were also able to cauterise all the damage that had been done to the cartilage, without actually having to cut me open. You know, it’s just three little holes. I was in traction for the surgery as they do have to pull the bone out of the socket so they can get into the joint. But the device that they use, I think it means the surgery lasts for an hour and a half and you’re in traction for about half an hour of that, whereas previously you were in traction for about three hours. So the damage to the surrounding tissue of being in traction is lessened under this new technique.
 
And I met with the surgeon and he saw the tests that I’d done and all the results, and he did some functional tests and sort of moving my leg around, and he could feel there was definitely an impingement in the hip. So he told me my options and he said that I was an ideal candidate for this new type of surgery. And he explained to me that it was new, experimental, hadn’t been approved by the government as yet, but the government were interested in approving it. So NICE, the National Institute of Clinical Excellence, had published a whole lot of information for both surgeons and for patients, explaining what the possible risks were, what the benefits were. And so I had to go away and read all that information and come back to him with any questions. And then if I was happy to go ahead with it, I signed a consent form. And I went ahead.
 
The way I understand it is that they’re going to carry out a certain number of operations and monitor the outcomes. And if it’s shown to be of benefit then they will make this operation available widely on the NHS. Currently you can only get this operation if you agree to take part in the study.
 
Do you know if they intend to make it a randomised controlled trial before they get to that point?
 
I don’t know, I don’t know. Yeah, because there is potential for bias, you know, obviously if they only choose the easy cases it is more likely to be seen as successful. So mine I believe was quite straightforward. It was quite a small lump.
 
And, you know, if I hadn’t been so active and so keen to be active again, then it probably wouldn’t have bothered me whether or not I had the surgery. So I guess my case was an easy case. And if they just choose people like me to put forward then it’ll look like it’ll be highly beneficial [laughs], because it certainly worked for me. 
 

The research nurse shared preliminary results with them and told them about presentations he was...

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Did you know when you agreed to take part that they were going to give you feedback about the results? Did they make that clear?
 
I can’t remember if they made it clear from the outset, but the nurse that was running the trial was certainly very keen that we knew. I think it was a way of keeping us involved, keeping us committed to the trial, was feeding back to us on a regular basis, the preliminary results and things like that and, you know, different meetings he was going to and presenting his early results, and showing that there was an interest throughout Europe in the results. So he made you realise that it was quite important.
 
We talked about sort of interim results each year, just basic information that, you know, it was looking like there could be an effect sort of thing. I think he did actually arrange for us to go into the hospital and he gave us a copy of the report. So it had all the graphs and tables and everything, and he took us through it. I’m not sure if he did that for everyone or just because I was particularly interested in the results. I’m not sure. But he was certainly very open to sharing the results with us. 
 

There was a small risk from the injections of anaphylactic shock, but there were safety...

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There was a small risk from the injections of anaphylactic shock, but there were safety...

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The main thing with the trial was that we were getting injected with grass pollen or a placebo. So we were randomised to either get the injection with the grass pollen, or get just an injection of nothing, really. And we didn’t know, and the nurse who was running the trial, he didn’t know either. And he had some assistants as well. And so no one knew whether we were on the grass pollen or on the placebo. We had to stay in the hospital for an hour after the administration of the injection, because they explained to us from the outset that one of the possible side effects, of an injection of something you’re allergic to, is that you go into anaphylactic shock [laugh]. And so they had a doctor always on site and stores of adrenalin. It was a precautionary measure but a quite interesting thought. But it was nice to know that they’d put that level of thought and care into it. And obviously it was part of them getting permission to do the study. So we would go in, we’d get gradually increasing levels of the grass pollen injected throughout the spring. So at the beginning you noticed very little local reaction from the injection, but as you got closer to your maximum strength of the dosage, towards May, I noticed certainly a local reaction, a swelling on my arm. And we were asked to monitor any reaction and tell them, like measure the size of the reaction, the lump that appeared, how itchy it was. So we’d feed that back to them. And throughout this whole period, and then throughout the entire summer, we kept a daily diary of our symptoms. But we didn’t have to go into the hospital during the summer months. So that made it a little easier and less of a time commitment. And we would pop into the hospital I think probably twice over the summer to drop diaries off and pick up new diaries, and so the nurse could discuss with us any issues we were having with the diaries.
 

There are strict regulations in place to protect patient safety, so the risk of something going...

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There are strict ethics requirements for the research to get off the ground. It has to be checked by ethics committees. So they’re not obviously going to do anything that’s harmful to you, and there are lots of procedures in place to prevent harm. It can go wrong, like the recent botched drug trials at Northwick Park*. But I think on the whole, the huge number of trials that are carried out, whether it’s a drug or a particular type of intervention or whatever it may be, Northwick Park was one out of many thousands that are carried out, and I think the odds of something going badly wrong are just minuscule. They made some fundamental errors in their administration of the drug and the industry has hopefully learnt that lesson.
 
*FOOTNOTE: Kate is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.
 

Kate's charity worked on a study with a drug company, and they found it really difficult to get...

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I’m kind of on the fence when it comes to drug companies, because we’ve done quite a lot of work with one particular drug company with one particular drug that was shown to have benefit. But because the, the drug company did the research, there’s all these question marks about, “Is it just because it’s that company?” You know, they’ve got a bad reputation for hiding bad results and only publishing positive things and possibly skewing their results. So we did an independent audit of this particular drug and we found it did confer benefit. But getting that study published in the scientific journals has been an absolute nightmare. It’s taken about nine months of constantly responding to very minor reviewers’ comments, until eventually the editor of the journal just went, “Oh, just publish it.” Because it had the association with the pharmaceutical company, even though it was completely independent, they had nothing to do with the study, we really struggled to get the work published. And it is shown to be of benefit. So there is, yeah, a bit of a stigma attached to pharmaceutical companies.
 
That’s interesting, that it’s actually thereby preventing results from coming out, rather than the company trying to suppress results.
 
Yes. I think that there was, there have been a few dodgy dealings, I think, in the pharmaceutical industry, and I think it’s really tainted their image and made things difficult for themselves, which is unfortunate. Because I think, you know, they do good. But it’s just the whole, “They’re there to make a profit” that makes it a little bit uncomfortable. 
 

Kate's husband was annoyed when he guessed he was in the placebo group. He continued for the sake...

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Kate's husband was annoyed when he guessed he was in the placebo group. He continued for the sake...

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The main thing with the trial was that we were getting injected with grass pollen or a placebo. So we were randomised to either get the injection with the grass pollen, or get just an injection of nothing, really. And we didn’t know, and the nurse who was running the trial, he didn’t know either. And he had some assistants as well. And so no one knew whether we were on the grass pollen or on the placebo. We had to stay in the hospital for an hour after the administration of the injection, because they explained to us from the outset that one of the possible side effects of an injection of something you’re allergic to is that you go into anaphylactic shock [laughs]. And so they had a doctor always on site and stores of adrenalin. It was a precautionary measure but a quite interesting thought. But it was nice to know that they’d put that level of thought and care into it.
 
How did you feel about randomisation and the thought that you might be ending up doing all this and be on a placebo?
 
I think, I kind of thought at the beginning - well, I thought about the odds. Obviously it’s 50'50, either you’re going to get it or you’re not. But I never really thought about not getting it [laughs]. It wasn’t until we were underway and I was clearly getting a local reaction and my husband wasn’t that we thought, you know, that is quite a commitment to make and you’re not actually - well, he wasn’t getting any benefit from it. And they didn’t make it clear at the beginning that they would make the intervention available after, at the end of the trial, if it turned out you were on the placebo. So I think he did quite well to make the commitment the whole way through and follow through on it.
 
Did your husband eventually take the option of having the intervention?
 
I think he did - I can’t remember if he did one season or two seasons, but he didn’t do the whole thing. It was just too much of a time commitment. But yeah, he definitely did one, and I think he might have done two seasons. And he did notice a benefit.
 
Do you think he regrets having been in the placebo arm as a result, or?
 
I know he was annoyed at the time, because obviously he’d made such a massive commitment to the study and he had hoped he would have got some respite over those summers. But I think he understood the benefit of doing the study, so he was okay with it. And plus there was the benefit anyway of having all these hay fever drugs thrown at you through the summer. So it did actually save us quite a lot of money [laughs].
 
And how did you both feel when the trial ended?
 
Probably relief [laughs]. Yeah, it was a big time commitment. It felt good to take part, but it was nice to get our evenings back [laughs].
 

Kate liked the fact that the research nurse tailored the information he gave to each individual...

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Kate liked the fact that the research nurse tailored the information he gave to each individual...

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The thing I particularly liked about the hay fever trial is that the, the research nurse that was running the study, he kind of tailored how much information depending on how interested you were. So my husband wasn’t as interested in, in the whole trial design and all the rest of it. So he got as much information as he needed. Whereas I was quite interested in how it was all designed and how it was all fed back, and decision-making and ethics and all that sort of thing. And so he was quite prepared to go into the detail with me. And I think, you know, if people are interested you should be flexible and give them the time. Helps maintain motivation.