Reasons for wanting to take part in a clinical trial - personal benefit
People agreed to take part in clinical trials for a range of reasons. Some people were thinking mainly about their own personal health, while others were more concerned with helping other patients and medical research more generally. Often, people said their reasons for taking part were a mixture of these. Here we look mainly at how people hoped their own health would benefit. (See also ‘Reasons for wanting to take part in a clinical trial – helping medical science and other people’).
All those we interviewed either had a condition already or were healthy people in trials relevant to their own health, such as cancer screening or preventive care. We did not include ‘healthy volunteers’ who are usually paid compensation to take part in early trials of experimental treatments.
For many, the hope of personal health benefit was their main or only reason for taking part. This might include getting a new drug or treatment they thought might help them; learning more about their condition; being screened (hoping either to be reassured or to get an early diagnosis); the chance of getting access to care they felt would be better or more specialised; or faster access to care. Some people added that they took part for their own interest or curiosity.
Several people wanted access to a new drug or treatment that was only available at that time through a trial. These included people who had an immediately life-threatening condition such as cancer, some of whom believed it was their only hope, and others with a long term health condition or other health problems.
Wendy is a teaching assistant. She's married with 3 children aged 16, 14 and 14 Ethnic background/nationality' White British.
Just before Christmas I went to a major hospital away from where we lived, and I had an appointment there to see one of the oncology team. I also saw a professor, who was leading a trial. They explained about the facts up until - you know, went over all the surgery I’d had, reiterated all the things the surgeon had told me, but added into that the news that out of the fourteen lymph nodes two had cancerous activity. I didn’t know at that stage whether that was good, bad or indifferent, but I wasn’t, you know, I wasn’t very happy about that. Based on that, that’s why I was offered the chemotherapy, because there is a strong possibility if it’s reached the lymph nodes it’s on its way elsewhere. So I was then told the, the plan was to have six months of chemotherapy. Alongside that I was offered the chance, if I wanted to, to go into this clinical trial. And whilst I’d been waiting in the waiting room I’d read up about clinical trials, so I knew exactly what they were talking about. I asked a few pointed questions. It was all taped, by the way, so we could take the tape away, listen to all the questions, listen to all the things the professor had mentioned. We also had it all in writing as well, so we could read it. Which was really, really helpful, because I asked a friend who’s a doctor of our, a doctor friend of ours to read through it.
She did some research. We researched it and we had about, I think, two weeks. We went back to see him, at which point he wanted an answer as to whether we were going to go through with it or not. We were explained to us that it’s a six-month chemo anyway, but the trial would be a twelve-month trial. So for the first six months I’d be on both, for the latter six months just the clinical trial. They explained all the side effects and everything. And after much discussion in the family, thinking about the impact on the children, and if all these side effects did materialise what impact that would have on us as a family with no extended family to call upon, I thought it was too selfish of me to ask for that. But my children said, “Look, Mum, we’d put our lives on hold for a year if it means that you’re going to be better at the end, if you’ve got a better chance of survival.” So I ended up deciding to go into that.
At that point we were told it’s 50% of the people that are picked go on the trial, 50% don’t. It wasn’t a placebo, nothing like that. You’re either on it, or you’re on the trial but you’re not having the drug. They wanted to compare the two. It was a drug that has been used very, very successfully in advanced bowel cancer patients and they now want to trial it to see what the implications are of it on other bowel cancer patients.
FOOTNOTE' Randomised trials are done when we don’t know which treatment is best, in other words when the relative merits and disadvantages of different treatments are uncertain. Of course trials are done because there is a possibility that a new treatment will be better than the standard or control treatment, and it may have already been shown to work for other conditions or groups of patients. However, trials are just as likely to find that new treatments are no better, or indeed worse.
Age at interview:
Pam is a retired solicitor and magistrate. She is married with 2 adult children and 3 step-children. Ethnic background/nationality' White Jewish.
Then I stayed on herceptin after the taxol regime had finished, and I was scanned, and the scans seemed to be showing things were stable, and this lasted for a year. And then suddenly, yet returning from the Edinburgh Festival once again, I was told that the tumour in liver had doubled in size. That was very dramatic, although on paper it doesn’t look that dramatic because it had gone down to 1.3 cm and it only went up to 2.7 cm, which of course was much less than the original, but it was still awful. And the oncologist said to me, “You wouldn’t have felt anything, you wouldn’t have known any difference, but we recommend that you go onto this trial drug.”
That at that point seemed to be the only option at the time*, and she left it entirely to me, and other people like my husband, to discuss whether or not I should go on the trial drug. Well, what would you do if you were handed a lifeline? It would have been very foolish, I think, to have refused that, and I felt very privileged to be able to go through it.
The first session - it’s tablets, which means that you don’t get a three-hour infusion, so in a way that’s better, but they have to work out the amount of tablets you should have depending on your weight and all sorts of things, and at the very beginning it’s experimental. Well, the first three weeks were pretty dire. At the end of the third week two of my toenails had come off and that was extremely painful. If it’s not losing your hair, losing your toenails is not a particularly viable option, but that was really very nasty. I had lots of horrid diarrhoea, which was copeable with because I had tablets for that, but it was not much fun, and in fact I was taken off the tablets and everything for two weeks while my body had a chance to recover, because it can be cumulative, and then the side effects can be worse in the end, and so it’s not worth it.
Anyway, we settled down to a happy regime, and the tablets have been varied, depending on my weight and how I’ve been reacting. Fortunately, the first scan after the first two sets of treatments showed that the cancer in the liver had reduced back to where it had started, in fact it went down to somewhat smaller - 1.2 cm - so that was very encouraging, so I forgot about the rotten old toenails. And then the next scan, which took place after two more treatments, showed that my condition was stable even though it had gone up by 1 mm they still reckoned that was stable, and happily it’s been stable ever since.
*FOOTNOTE' At the time Pam agreed to take part, the drug was only available as part of this study.
Age at interview:
Anton is an auditor. He is single. Ethnic background/nationality' Sri Lankan. (You can see more of Anton talking about his experiences of depression on our site on Mental health' ethnic minority experiences, Interview 13).
Different psychiatrists gave me various antidepressants and at a certain stage they said to me, “Pharmacology doesn’t work for you, therefore we are discharging you. That was it. That was no consolation. I wanted to hold my job, I wanted to live. I still had ambition in my heart, I still want to go on.
As I was so desperate, I tried alternative remedies, acupuncture, acupressure, homeopathy, reflexology - you name it. But of course these alternative therapies they make exorbitant claims. And no proper clinical trials or any of these things. Although my doctor and others in the traditional medicine warned me about this, I thought, “One in a million chance it may work.” The only net result was none of them worked, only it lightened my wallet, end of the day, and that was it.
So one day when I was reading newspapers, I see this advert' “Clinical Trial, need volunteers”, and that is when I thought, “Well, nothing works. Let me even try this.”
Age at interview:
Charles is a retired chief engineer. He is married with 5 adult children. Ethnic background/nationality' White British.
Well, the prime reason was that a friend of mine did have prostate problems, cancer, and there was, you know, my family was sort of saying, well, I’m at the age group when you ought to be tested, though I know there is a lot of literature written about this particular subject and it’s almost debatable as to whether you, there’s an advantage of knowing, because a treatment sometimes is debatable as to whether there’s a benefit or not. But I was interested, and because I felt that was a decision that I should make if I was, and so when it came up to alleviate the sort of pressure that the family put on you [laughs], I was quite happy to go ahead with it, putting my name forward. And those sort of things interest me. I mean, I don’t have an issue.
And you mentioned earlier about retiring and it being a way of --
Oh yes, yes. No, I think that is also an influence, I mean you know to get a trip over and see another – well, in this case it was a fair journey to go to where their testing took place. And you know, you meet new people, you talk about different things, and that’s always of an interest to me. And therefore I think I like to keep busy, so it fitted in to the, my mental [laughs] at the time. You know, I sort of felt that would be a good thing to do.
To fill the day out a bit more--
before I got too busy on other things, which I have now [laughs].
[laughs] Mm. And often with these trials there’s a mixture of motivation for people. A bit of it’s about wanting to do it for yourself, maybe as you say about wanting to do it for your family, sometimes just wanting to support medical research. How would you say those balanced out in your case?
Oh, a selfish one, I think, primarily. Not, I’m not talking about going for putting my name forward for various trials, but this particular one that we’ve been talking about today primarily. Yes, I was wanting to know whether this might be, you know, a help to me because of the obvious disadvantages with the current method of help that, you know, Viagra or whatever. I mean, they work but it’s very cold blooded, and quite often there’s a very significant delay, and quite often that delay is not acceptable [laughs].
Age at interview:
Kate is Operations Director for a charity. She is married with no children. Ethnic background/nationality' White New Zealander.
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.
In making their decisions, people weighed up potential benefits against possible risks or side effects. (See also ‘Side effects and queries about clinical trials’). But it is important to bear in mind that until a trial has been completed, no-one knows if a new treatment is better than the standard treatment already in use. ‘New’ does not necessarily mean ‘better’. Indeed, new treatments are as likely to be worse than existing treatments as they are to be better. The UK Clinical Research Collaboration booklet ‘Understanding clinical trials’ includes a useful section on the risks and benefits of trials (see Resources).
So I’ve always been asthmatic, and it’s, I would describe it as managed. The last full blown attack I had was about fifteen years ago where I had to go to A&E and be put on a nebuliser. I recently had a chest infection which dragged on for about two months, and the symptoms of asthma were overlapping with that, so it as difficult to tell what was asthma and what was the chest infection. And I was tempted to go to A&E about a week ago because it seemed particularly bad, and I was worried about cardiac symptoms, because I was coughing a lot.
I, the clinical trial I was involved in came through my GP and the practice that I was a patient of at that time had a very good asthma clinic. So through that, I was asked if I would be interested in participating in a trial at the [specialist] Hospital which would be educative for me, and would be helping to find an up-to-date cure for asthma. So I looked into it, and I went to meet the doctor in charge of the trial, and it was very much sold as an altruistic thing, that we would be helping people with the same condition. And I decided to do it because I was interested in what the trial was about. I have to say that there was a fairly generous sort of expenses package [laughs]. That was one of the factors, I have to say.
Obtaining extra information was Sue’s main reason for taking part in a trial of various decision aids to help women with birth choices after a previous caesarean. (Our site on ‘Making decisions about birth after caesarean’ features interviews with other women involved in this trial).
Sue used to work as a financial adviser and veterinary nurse. She's married with 2 children aged 5 and 1, to whom she's now a full-time mother. Ethnic background/nationality' White British.
So tell me about what your motivations were for taking part. What was the most important thing for you?
I think because I’d had emergency, an emergency caesarean and, you know, I’m quite a large frame, I had quite a small baby - well, a small baby relative to my size - and almost felt that I’d failed because I couldn’t deliver her normally. My first child wasn’t, it was not a normal delivery. And you think, “Oh, maybe it was I was too much of a wimp and I didn’t push hard enough, or maybe, you know, it was my fault.” And I do think, you know, speaking to people who’ve had caesareans as well, you do feel a bit of a failure, because you didn’t do it normally. And then there’s other people just go in and they [clicks fingers] pop their babies out and it’s not a problem.
So you do feel that you’ve failed in that way, although the medical people tell you, you know, “This is why we did it and, no, you’re not a failure”, but you still, you know, you have one conversation with the surgeon afterwards or something and then you sort of forget it, because you’ve just had a caesarean. So I think from that point of view it was to make you understand all the things that can, well, maybe go wrong in a normal delivery, maybe understand, you know, why caesareans are done, and it was just really to, for me - well for us - that second time around that we could make a clear decision about what we wanted to do. And then it, like I said, you know, it’s just better to have more facts, more information, for you to be able to think it, think it through and decide what you want to do, so.
So it was really the benefit of having that extra information was, was the main attraction for you?
Yes, because you can - that’s it. And I’m sure most, like most women when you’ve been pregnant you’ve got so many things going on in your mind, so many things when you go and see your doctor, your consultant or your midwife, and, well, you know, you have - really you have to write all your questions otherwise you forget them. But it’s better to, for then you would be able to then sit down yourself and go through it. You can discuss all the things with the person, the medical person, but then you can actually sit back in your own time and go through it again* and just, you know - and if you want to go through it again and again you can, because it’s there, it’s accessible and it’s in your own home. You’ve got plenty of time to do it, and it just makes it easier.
*Footnote' The decision aid information was shown to women on a laptop by a researcher, and was also available on a website for women to look at again when they wanted to.
Some evidence has suggested that people who take part in a trial – whatever treatment group they are allocated to - have better health outcomes than people who do not take part in trials. This is known as the ‘trial effect’. However, in 2008 reviews of the evidence have shown no significant differences in health outcomes for people given similar treatments within a trial or just as part of their normal care. (See the Cochrane Review by Gunn Vist and colleagues - Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate).
However, even if the outcomes are similar, many people felt they received better care in a trial than outside it, whether this meant more regular monitoring, more frequent appointments, being looked after by experts who specialised in their condition, or less rushed appointments and more time to ask questions.
Phil is a retired post office worker. He is single. Ethnic background/nationality' White British.
What, looking back, would you say were your main reasons for wanting to take part?
Well, the fact that it specialised in something I had, a problem I had, and these were people who were specialising in that subject. So they were - well, I suppose they knew more what they were talking about, to put it, you know, put it bluntly [laugh]. It tended to be they gave you much more time. You went there and they took say nine or ten readings, which gave them a much more accurate reading of your blood pressure. Whereas your GP would only have time for one, usually just one reading, and very often it’s much higher than you’d expect, you know. What tends to happen is the first one’s high, the second one’s slightly lower and then the third and fourth ones are a little bit lower still, and then they, it starts to level off. So it’s a much more accurate way of, you know, finding the reading. And, yeah, I mean it’s so relaxed. You know, you’d there for about an hour, two hours. If you’re giving blood, you had to fast for twelve hours, so you had sort of tea and toast and biscuits and all that afterwards [laugh]. And you just felt you were being well looked after. You know, I wasn’t rushed in and rushed out.
Did, were you at all thinking about the wider importance of research for the rest of society? Or was that not really an issue in your decision?
Well, I suppose I was, but to be honest I think it’s more of a sort of personal thing, you know. I mean, I was glad other people can benefit from what they’ve found out. That’s a general thing. But at the same time it’s helping me. It’s my personal, you know, it’s a problem I had. So I was quite happy to do it. But I suppose, yeah, it, it does, it does make you feel better knowing you’re, you’re helping other people. Yeah.
Harry said he was usually reluctant to bother his doctor and saw the trial as an opportunity to be screened for problems before they became serious “I think I was 72, about, and I thought it would be a good time if I would have a medical procedure which would find out whether I had any age-related conditions which you would get but you wouldn’t know about it until it hit you hard…That was the main reason, of course naturally selfish - they’ll watch me and they’ll tell me if there’s anything wrong.”
People who take part in trials often feel they are taking an active part in their health.
Danny is a retired teacher, who now does voluntary work with her grandchildren and their schools. She is married with 2 adult children. Ethnic background/nationality' White, mixed ethnicity.
I was written to, my husband and myself were written to by, I think, our GP who - or the labs where the stuff was being done, the trials were being done, wrote to us and said that, “We’ve got your name from the GP.” I really can’t remember, but my doctor was connected. And so my husband and myself went, were invited to go to the trials, which we did. And we, because my husband had been on previous trials, which had lasted, they were supposed to last five years and I think they nearly did, but they concluded. They had a result, so. But while my husband was on the trials they found out he had type two diabetes. And that was something that had he not been on the trials might not have become evident, and it was picked up at an early stage. And because my husband was on the trials, and because I used to go with him, because it was interesting to me just to get up, and we used to go on our bike for a bit of exercise sometimes, I felt that we were getting a real bonus from being on the trials, because I knew what they were doing with his health, how they were monitoring it. He was getting ECGs. He was getting blood tests frequently, which [sighs] - I mean one could say [laughs] you don’t need to keep looking at your blood, but it was a small issue and a small sacrifice for something that enabled the two of us to focus and deal with his problems seriously, rather than a random visit to the doctor that might have had a much lighter touch.
So I think that it, the whole thing helped him to focus more - well, for both of us to focus on our health - not that we didn’t before, but it’s like you’re under scrutiny. So it didn’t seem a bad thing to do. It didn’t seem to be very imposing in terms of time or effort, and obviously one gets accustomed to going there, and the staff there, a small rapport builds. So that’s quite nice in a way, that there is a personal element to it. It’s not cold.
Iain Chalmers, one of the authors of the book 'Testing Treatments' (a web resource is available at www.testingtreatments.org),, commented “I carry around a card with me saying 'invite me to participate in any randomised controlled trial for which I am likely to be eligible'. I don’t do that out of any altruism; it's purely selfish.”
Looking back, better care or attention was often mentioned as an unexpected benefit of taking part, even if it was not something that influenced the original decision to take part. Ronny said, “I think I possibly got the operation done quicker because I was in this clinical trial”, but other than that he thought there was no difference in treatment. Alex was originally told he might have to wait a week for a CT scan, but after consenting to the trial he had the scan within a couple of hours.
Alex is a University Lecturer. He is married with 1 child aged 6. Ethnic background/nationality' Russian.
They did a, they did the x-ray first and somebody must have looked at it. I don’t know. I think I was, I think I was told I need a CT scan but the scanner was very busy and I can expect it to happen in a week’s time. And then I think at about, in a couple of hours’ time I was seen by a consultant and his team, and the heel fracture trial team, and I gave my consent, yes, immediately. Why not?
And that’s, I am a scientist myself so I understand very well why it’s needed. And then miraculously the CT scan was done within a couple of hours [laughs]. So I don’t know if that’s a coincidence, but I started seeing a benefit almost immediately. Well, I sort of felt, I mean obviously it shouldn’t matter, but I somehow felt that maybe it’s just psychologically for me, but I felt I am getting somehow slightly more attention because, because I’m not only looked at by the consultant but there is a whole team of people who are actually interested in me. And, and I’m also useful for their research, and my, my kind of fracture is exactly the thing that they are studying.
Have you felt that throughout the trial, that you’ve had special attention, better care in some way?
Not better care, no. I’m sure it wouldn’t be any worse otherwise. More attention? Well, maybe - again I don’t, I didn’t have any serious medical problems before, so I don’t really know what to compare it against. And obviously this is not one of the most serious medical problems that people have, and obviously it, it doesn’t deserve more attention than it’s getting, but - well, probably, I don’t know. Probably, maybe.
Age at interview:
Fenella is a clinical audit assistant in a mental health NHS trust. She is single. Ethnic background/nationality' White South African, UK citizen.
The thing that I found most interesting was that I actually had never been given a proper diagnosis before, and I’d gone to this unit and I’d been given a proper diagnosis. I’d been offered the most up-to-date treatment, which seemed to have, the early results were quite encouraging, people seemed to do well. And that my psychiatrist was quite encouraging, whereas before the other psychiatrists who had treated me were quite negative and quite pejorative actually towards me. He was, he didn’t see me as difficult. He saw me as challenging and complex, but not difficult.
And it was his area of expertise. And that made me feel as a patient that, that there was some hope for me, whereas traditionally in the past I was seen as, as someone quite difficult. It, it was really nice to be with a team who were really quite encouraging. They weren’t just doing it in terms of a research thing, but also because they had a genuine compassion and interest for people to get well. And they were researching this subject because they only wanted to offer the very best treatment, not just treatment that they didn’t know where it was going. And for me that, that was very encouraging.
As, I was in treatment for, in the day unit for three years and that, for that time, that’s when the trial sort of went on. And there were some people who opted out. And my own view was that was sad, because I think that, you know, every person who had the chance should have entered, because even if treatment wasn’t successful for them, that we, it could have been explored within, as part of the research process, to find out a bit more about, about what does and doesn’t work.
However, other people felt there was no difference in the care received. Wendy had thought being in a trial would mean better care but was a bit disappointed that this did not seem to be so. (See also ‘Appointments, monitoring and questionnaires’).
Wendy is a teaching assistant. She's married with 3 children aged 16, 14 and 14 Ethnic background/nationality' White British.
I did sort of feel a little bit that - I know he’s a very busy man, I never saw that chap again after the time I said I’d like to go on the trial. And I sort of thought, “Yes, okay, you’ve sold it to me and now you’ve gone.” Because the funny thing was family members had said, “Wow, you’re going to get really looked after. A professor. And, you know, he’s doing all these studies and he’s really well up on cancer, in a cancer hospital. You’re going to get so well looked after.” And I tended to think that as well. That was one of the plusses. So that even if I hadn’t had the drug, I was on the trial, I would be really well looked after. I did sort of feel that once I’d made that decision, it was a bit like buying a car, the after-sales service, I thought, it was, it was okay. I mean, I can’t say I complain about it. I did feel that you were rushed. You, every time you went every three weeks to get your treatment you would not have a lot of time to talk about issues. It was a quick tick list. “Have you, how’s, how bad are your feet? How bad are your hands? Have you had the runs? How often have you had the runs?” Which is why they’re, they obviously have to take that for their own records, and if it had been too much they might have reduced the dosage. But I was lucky, really, that they never affected me that badly until the very last cycle, when obviously it accumulates into your system. I was very lucky that it didn’t, it never sort of stopped, I never had to stop, and I never had any reduced, apart from the last dosage. But I did feel that because of - and I assumed that - the strains on the NHS, the amount of cancer patients going through that hospital, they didn’t have a lot of time for you to discuss your worries. They did have a phone call line you could ring, but often you’d get an answer machine and they’d ring you back. And if you were worrying about something, that seemed an increasingly long time to have to wait to get an answer. Because we were told, “Come to us. Don’t go to your GP because they won’t have a clue about what you’re talking about. We understand the symptoms. We’ll be able to tell you whether that’s something apart from the treatment or whether that’s linked to what, the treatment you’re having.” So I did sort of feel a bit - but that I could understand, they’re very, very hard pushed, there were a lot of patients going through that hospital. So I understood it.
Meeting new people and building up friendly relationships with staff or other patients was also felt to be a plus looking back, but again was not a major reason for deciding to be in a trial in the first place.
Anthea is a retired administrative officer. She is married. She had one grown-up daughter, who died. Ethnic background/nationality' White British.
If there was any chance of stopping the disease, or halting it for any length of time, I would give, I would want to give myself that chance. If I said, “No, I don’t want to. I don’t want to do this”, I think I could have had regrets, saying, “Well, if I’d have done that, perhaps I would have still been here.” You know, once you start getting ill, “Well, if I’d have done that, perhaps I’d have stood a better chance. Perhaps it would have slowed down the disease.” And there would have been lots of ‘what ifs’. I’m not into ‘what ifs’. I want to be positive, and I think anybody that knows me will say that I am a very positive person. I’ve had lots of knocks. I’ve had lots of things that I could have said, “Well, why me?” But you pick yourself up, and you’ve got to look to the future. You, you can’t, you can’t look and think, “Well, why did that happen?” These things, things happen in life. “Why me?” I’ve done that. “Why me?” But when I’m feeling, if I’m feeling down then yes I do, do think, “Why?” You know, “Why is it me? What have I done wrong to deserve this when there’s so much going on in this world that it could be somebody else?” But [sighs] when I think logically and positively, then I think, “Well, yes, it’s got to happen to somebody. It’s happened to me. I’ve got to get on with it.” I want to do lots more things in this life and if I’m to do those then I’ve got to take the chance of these trials.
So your main reason for taking part is about taking every chance for your own--
Plus the fact it might help - if it doesn’t help me, it might be something that will help somebody else, and if it helps somebody else to save them going through the trauma that I’ve been through, then I’m, I’m happy to do it. If it, if it helps anybody, you know - it might be it might be a friend, it might be a relation, it might be somebody I don’t, don’t ever have contact with or know, or know that it’s helped them - but if I’ve done this and it does help somebody, then all well and good. There’s a purpose to it.
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