She explained to me that it was a trial of people whod already had one caesarean, and how that they, how they wished to proceed with the second birth, or the following birth. And she told me that there would be different, there would just be different questions, different facts, you would have, be given more information, and that – to help you make your decision. And that she said that I would be interviewed by people, and she told me that if I wanted to pull out at any time I could. If I, you know, wanted it to stop, I could.

And obviously everything would be treated confidentially. And then she asked me to, as I wanting to go forward with it, you know, to take this piece of paper away, read all about it and then sign it, and, you know, send it back in, which I did. I mean, well, I actually just signed it there. I mean, I read through it there, and then signed it, so again, so…

And so did, did she say what the different groups were going to be in the trial, and how you’d be allocated to one group or another?

I can’t remember if she said it then, or whether it was later, I really can’t remember. I was told – actually it was on the information sheet that I was given, that there would be three different groups. One – and I can’t remember the exact things – but one would be, you know, different decisions and different, there would be three different segments of how the trial would be run, and you would be allocated into one of the groups, and that was actually written down in the thing.

Do you remember what information you were given, what kind of things you were given to help you make up your mind?

Oh, that was actually quite helpful, because I was given a – I was already in hospital, in a hospital bed – and I was given a portable DVD player with a record of, of the head of the team, a professor, from the university who are running this trial. And, and there was quite a detailed explanation of what the structure is and how it’s treated, and what the options are so I think this was one of the most useful things that, that I actually received as information, yes. And there were leaflets and there were forms, but actually, somehow this, it helped to see this DVD, yes, definitely.

And did you talk to anyone else to help you make up your mind? Did you talk to your family, your wife?

To make up my mind about taking part in the trial? Well, my wife was around at the time. I mean there was no question. Why wouldn’t I take part in the trial? So I don’t I don’t remember if I actually discussed that, or it was obvious to both of us, but it was I think obvious, yeah. Why not?

I think anyone being asked to take part in a trial should ask some quite penetrating questions. I mean, I think first of all they should approach it in a positive state of mind that on the whole we patients would like to help science wherever at all possible. Doctors are trying to provide better proof, better evidence, better treatments, and I think it’s the least the patient can do is to help as much as they possibly can. But in the end you have to look at the particular trial very, very carefully. And I think really you need, it’s a good idea to get a second opinion from somewhere else, if it’s on something that’s very important. I mean, if it’s something minor, obviously not. But if it’s something, you know, possibly life-threatening that you suffer from, then I think you really need to know all there is to know about the treatments that you’re being offered, or possibly denied, if you’re going to be randomly put into a group that’s going to get a, what might be a very good treatment or into a treatment that perhaps might do you some damage. You need to know what those risks are and decide whether you’ll take them or not. Of course some trials, you’re not going to be offered the treatment unless you’re on the trial. I think that’s a very, very difficult call and I think that puts a lot of pressure on, on patients who perhaps very much want the treatment, can’t get it any other way, but might be randomly assigned to a group that don’t get it.

And I think that’s a deep ethical dilemma. Of course if it is a very, very new treatment and the scientists genuinely don’t know if it’s going to work or not, I don’t see how else they can proceed except on that basis. So I wouldn’t rule it out and say, That’s unethical, that’s unfair, because I can’t quite see any other way of, of resolving it. You can’t give everybody every drug that might have some effect indefinitely. It could be dangerous as well as expensive.

It’s very difficult, obviously, for the doctor or whoever it may be that’s talking to you to gauge what level of understanding you already have, so they don’t want to talk baby talk to you, but equally they don’t want to talk above your head. I don’t mind particularly if people talk baby talk to me because I can indicate that I want to know a bit more in detail. I do get irritated with people who talk baby talk and seem unable to go beyond that. So then I take a very dim view. I think, This guy or this woman doesn’t really understand what they’re doing. They’re just like the repair man that comes to tighten up the screws on the fridge without really understanding what’s going on inside. And so I feel dissatisfied if the doctor I talk to doesn’t understand, or doesn’t show that they understand what’s going on.

Have there been some instances where you’ve felt they didn’t really understand the trial or the, the mechanisms involved?

Yes, not I should say at the research-oriented hospital that I’ve been to, though even there, there were one or two cases where people I thought seemed a bit dim [laughs]. But anyway, that’s inevitable and one shouldn’t complain too much. People talking above your head I don’t mind, because I’ve got in the habit when I don’t understand something of saying that I don’t understand. It’s quite a difficult habit to cultivate, especially if you’re supposed to understand and know about things. But I would urge patients always to stop and say, Stop, and, Explain that to me. I don’t know what this is or that is.

So where have you been more conscious of this people not really understanding? Is that at the Gps surgery or?

My GP has been fine. He doesn’t lay claim to knowing all the ins and outs of the molecular biology. He says that’s not his concern. He refers me for that, but he’s very good on all the things that he undertakes to do. The specialist hospital has been fine, by and large. But the intermediate place where I was first diagnosed was more uneven, so there are some very good people and some not so good.

We were all getting the drug, and there were, the explanations from what I can recall were very good. It was explained again about I can withdraw at any time, if they find I’m having bad effects with the drugs that they’re giving me or, then they would pull me out, because I think obviously they were looking at the quality of life, as well as trying to find out if this drug was effective, you know. I have no complaints about that side of it at all and the nurse, the research nurses who were involved also were very good at explaining, and they would take their time, either if myself, or Helen, or any of the other patients who were there had questions. Some patients didn’t have questions. As usual some people want to know everything and some people don’t want to know anything, some people want to know a wee bit, you know. But because my, I felt whatever was going to happen to me, whatever decisions I was going to take it was going to affect my whole family, so I wanted to know everything, which perhaps maybe made it a bit easier for the medical staff because they knew, Well, Tom wants to know, so we can talk to him, we can tell hi, you know. But I have no – on recollection the medical staff at that time were very good with their explanations.

There was quite a lot to read, and I think sometimes that can be off-putting because, you know, sometimes you haven’t got the time to go through all the pages. And you put it away and you think you’ll read it, you’ll read it, to the point when sometimes it becomes quite urgent, when you’re about to go or take part. So it would be nice to have it in a like condensed way, with like the summary, which I think would be better, instead of pages and pages of information which sometimes people don’t have the time to go through.

Sometimes a lot of writing and a lot of paperwork can be off-putting. If it was to the point, summarised, condensed, and pinpointed the exact points that are more important would be beneficial and it wouldn’t put people off taking part in these researches.

If it was, if you were a doctor or you had medical experience, I think you would have probably read it and understood it. But it took me from one oclock in the afternoon until six oclock at night reading it, reading it and reading it. And in the end I decided what I wanted to query I had to mark on it, and there was quite a lot that I was querying. I wasn’t very happy that they said that one person on this particular drug, a lupus patient, had now become ill and developed leukaemia with it, and that put me off. It also said that they gave you a list of side effects it could be, but of course being a trial there were probably side effects they didn’t know about yet. It didn’t seem as though it’s been going on for long so they don’t know what was going to happen in the long term. Legal implication was that you could have your statutory rights when claiming any damage caused by the drug company, but then underneath it said quite clearly, of course, this has got to be confirmed that it was actually the drug that caused the complications in the first place, which alarm bells went. How do you fight a drug company and how do you prove it was them if you’re not well? And these are all the things I underlined but I think there were about five pages which were absolutely full of medical jargon, sort of medical information which I frankly couldn’t understand. It was a doctor talking to a doctor not a doctor talking to a patient. I class myself as reasonably intelligent but had I not been intelligent it would have been very hard to understand. And after six hours I was angry because I saw the implications. The more I read and the more I understood it the more it annoyed me.

But the, most of the information I think has got to be in a language which the general public can understand, not the language of a doctor. And I think that’s where they failed as well.

So what did you understand about the trial? Did you understand what its aims were?

[Laughs] I read all about it and it explained in full detail it, its claims and its aims but it then stated, as the lady doctor had already stated in the hospital, that it might not do me any good at all. If it did I wouldn’t be able to get the drug again. And also it was supposed to be the genetic make-up of the CLL [chronic lymphocytic leukaemia] that they were investigating and a lot of things that I didn’t actually, I never did understand. I rang a friend who was a consultant at Harley Street, a Nigerian doctor I was with in Nigeria, and he, I sent him a copy and he actually went through it and he said, No way And he understood it.

He understood the medical implications of it.

Well, I had a letter through the post inviting me to take part in this trial, which is a very large trial over a ten- year period, designed to answer questions about the effectiveness of screening for ovarian cancer. There was a leaflet attached to the letter which I read, and I thought about it and I discussed it with some friends and colleagues, and I decided that the information in the leaflet really wasn’t sufficient for me to make a decision. So I replied saying that I, in principle, was happy to take part, but I’d like them, the trial organisers, to send me a copy of the full protocol. And there was then a six-week silence, and then I received the full MRC [Medical Research Council] protocol which did indeed, you know, answer some of my questions. And I felt some of the way the information was presented in the protocol and in the leaflet that went out with the initial letter was rather different. But I decided that I would take part. I also decided that I would like to be in the control group [laughs].

And then followed a slightly stressful period, in which I was sent appointments to be recruited and they were all during the working day. And I explained that I was in full time work and I needed an appointment either early in the morning or at the end of the day, and this proved impossible, which I think is a bit of a mistake, as many women – this trial is aimed at women aged between fifty and seventy-four – and many fifty to sixty-year-olds these days are in full time work. So after a bit of argy-bargy I went along at four oclock in the afternoon to the local regional centre, and was told that I had to watch a video. And I said, I’m sorry. I don’t have the time to watch a video and I have read the protocol and I think I know what this is about.

Anyway, we completed the formalities, and then I suppose there was an interval of a few weeks and then I received a letter saying that I had been randomised to the control group, which made me happy.

There is a comparison between two different screening strategies. One of them is called multi-modal, and that involves blood group, blood tests and then, if the blood test shows a particular result on the protein called CA-125, the trial participant has transvaginal ultrasound. The second group is the ultrasound only. It seemed to me that this method of ultrasound screening was likely to involve some discomfort, and I didn’t feel that that was actually spelt out in the leaflet. Nor did I think that the leaflet was explicit enough about the anxiety that can often be created when people take part in these kinds of studies, because there is always the risk that you’ll get a false positive result or a false negative result. And what was interesting to me was when I read the full protocol it was clear that the second aim of the whole trial was to assess the morbidity associated with screening and that wasn’t, I don’t think, clear enough in the leaflet.

I think it is important to be as honest as possible, and that if there had been a little bit more honesty about some of the potential disadvantages of being involved in these screening strategies that are being evaluated, I don’t think that would have actually put people off. So, I mean that is obviously the concern, isn’t it? But again you can really answer those questions in good pilot studies, and I don’t know what kinds of pilot studies were done for this trial, whether the recruitment strategies were piloted, whether the information leaflet was piloted. But it is possible to answer those questions in advance of, you know, the full blown trial.

And then I have difficulty with some of the literature they write, you know, and particularly being an older person now I’ve found in my latter years nursing that all of these new fangled things, you know, were quite – and I hated how everything was shortened. And so therefore, you would hear in the beginning of a, something which they would say RT’ and then it would be repeated. They would give the full name, right, the full condition and then a little further on they would just give the capital letters and you’d be thinking, Er You’d waste half of your time. So how people understand all of, all of the jargon that was thrown at them, even though I suppose that we think it’s simple [laughs]. it’s not very simple for lay people.

What do you think could be done better with the information? I mean, you talked about the fact that many people that you met didn’t really take it in.

Uh-huh.

How could that have been improved?

I think it’s simple, absolutely simple, and absolutely impossible with every thing with the National Health Service now. There is not enough staff. To me sometimes they’re throwing money in the wrong direction. There are so many chiefs, very few Indians. You know, and up in that clinic, it’s really is so busy and so few people are having to deal with it, it’s , so really the answer is there’s no answer. No answer to it. Because if you have too much staff then you’re falling over each other. There just isn’t an answer.

Are you suggesting they use written information too much because they haven’t got time to talk to people?

Yes, yeah.

Is that it? Okay.

Yeah.

So your preference would be for somebody, rather than giving you a leaflet and telling you to go away and read it, to —

As I say, with me I was quite happy to read them, but I know from what I see other people don’t read them. And I mean it really came up with just the, you know, all of the information that was given, maybe a couple of sheets of paper for when we went for the CHART [Continuous Hyperfractionated Accelerated Radiotherapy] that they hadn’t understood bed and breakfast’*, hadn’t understood at all. But they told me what bed and breakfast was, but I retained it, you see. Nobody knows until they’ve experienced it before the confusion that really is in your head when you’re told. Like I said I started clearing a drawer out because the next day I was going to the [name] Hospital – instead of doing things where I would do it normally, you know, get my things out, pack a case, inform people who should be – no, no. I decided I had a drawer that was really messy and I really should, you know – crazy things. So I mean if my head had gone crazy, God help what other people’s heads were.

* The Bed and breakfast’ system Rose mentions means an overnight stay for radiotherapy but not as a full in-patient. Patients are asked to bring their own medication with them, but some patients Rose met had not understood this.

Well, you’ve got to trust them [doctors], you’ve got to trust them. Whether they are good or not, you’ve got to trust them. They are the ones who go to the medical school to, for the purpose of helping those who are sick and all that. So you’ve got to trust them.

As I said before all that I’m concerned is what they are doing, or what they can do to help me to bring back my blood pressure down to normality. That’s what I was concerned about. Whether it was one group or the other don’t matter to me.

I’m not saying that people shouldn’t go on trials but I think you’ve got to fully understand what they’re telling you, and for the general public that’s very difficult because we don’t understand medical terms. I was lucky because I had medical people behind me that could help me and I’m not stupid. And because it was just funny that the points that I made about this clinical trial were brought up by medical people as well, and they all seemed to have the same impression that you go into the trial, you go on, you give the approval and you do it.

But I think people have really got to understand the implications of doing it and I don’t think there is enough care given that they do understand, because we’re not medical.

What would you say to anyone else thinking whether to take part in a trial, not necessarily this one?

I’d tell them not to agree. Get all the information from them that you can. If you don’t understand it find somebody that can help you. it’s got to be somebody medically because without medical experience you can never understand it. It depends on your situation. As I say, if you’ve got six months to live and there is no hope for you and the trial is a chance, I think you have to take it. But if there’s hope with other things I think I would sooner put my faith in the drugs that are already available. But that is personal, this is me. I can’t read how other people feel but I do know that when anyone ever offered a drug and they’re seriously ill, their only hope that they’ve got, or what’s in their back of their mind is, that this trial is going to get me well. And that’s in everybody’s mind, not just me, that’s not personal. And I feel that you have to consider it at your own merits but you cannot go into that trial unless you have sat down with a friend or family whos probably, or preferably, with medical experience, and he goes through with it with a fine tooth comb. And then you have to consider it. But I still think you’ve got to be very careful.

Within the trial steering committee there are people from a broad range of disciplines and say several laypeople. And one of the things the laypeople would look at, and have quite a lot of control over, is things like, Well, from, what would be acceptable to a person with no other agenda other than to get better or to learn? And how can you present that information? So things like patient information leaflets, patient briefings, all of that would really have a big stamp of the layperson on it, so that they could look at it and say, Yeah, this fits the bill. Because again, you can imagine if you’re seeing somebody like a doctor or a surgeon who you hold in high esteem – because we do hold them as a profession in high esteem – it’s not a meeting of equals. They are in a position of power. I’m not saying they abuse it, but they are. They’ve got the knowledge or some of the knowledge, they’ve got the strength, they’ve got the reputation. There are you, or either as the individual or as a representative of an individual, sort of feeling vulnerable because you’ve got an illness, lonely because you’ve got the illness and here’s somebody who wants to talk to you about it, and also ignorant of a lot of what’s going on. So that meeting is a meeting of un-equals. And the trial steering group, I think, just try and make sure that all the information that a patient or a carer has is good enough to be able to get over that, that element really.

So it’s a huge problem of uncertainty what to do with this thing [DCIS, ductal carcinoma in situ, in the breast] that we’re now finding. So at the time I was only vaguely aware of this, but as I’ve learned more I suppose the, what has concerned me about seeking informed consent to enter a trial, particularly of, one of this nature, is the information that women need to have, the knowledge they need to have, and that this is almost irreconcilable and impossible, because how can your average woman on the street, like I was, be expected to know the ins and outs of randomised controlled trials, for a start off? If you don’t know what a trial is for, what its purpose is that’s a bad start. If you’ve just been told you got cancer, that’s a pretty bad start. If you don’t know much about the cancer you’ve got that’s not much help. So to have to give informed consent and agree to participate in a trial is a pretty tall order. That’s where I came in.

I think choice in medicine is a very difficult thing, and I think patients are often themselves uneasy about it. And you do go to your doctor because your doctor’s the expert and say, What do you think, doctor? What should I have And you can ask for lots of explanations. But in the end if you trust your doctor the odds are very strongly from all the evidence that most people will do whatever their doctor suggests, probably sensibly. If you don’t trust your doctor, then go to another one and then you’ll do what the other doctor suggests [laughs]. A lot of people will come to doctors with great piles of documents they’ve printed off the Internet, some of it from rubbish sites, a lot of dangerous stuff out there on the Internet. And, you know, the doctor then will spend a long time going through them and saying why they think they’re right or not right. But in the end it is down to trust. So choice is quite difficult. And I think, you know, the same is true about choice of which hospital to go to or which consultant to be sent to. In the end you probably trust your doctor to say, Well, Mr so-and-so at X hospital has, you know, always seems to have done very well to my patients And I think lots of patients, and particularly the sicker they are, don’t really want choice. They want trust. And choice and trust are in different boxes. And very often if you’re left on your own to make really life-and-death decisions it can be very upsetting. You want to be reassured by someone who seems to know.

I guess there’s another conundrum, really, isn’t there? Because in trying to present a trial as a case of genuine uncertainty, there’s a risk that the doctor may undermine your trust by sharing that uncertainty with you.

I think that’s true. I think if a doctor says, Well, I really don’t know. You’ll have to choos, it can be very unnerving, because you really do want him to know. Or at least you want him to, you say, Well, all right. I understand you don’t know Perhaps you want him to be honest about uncertainty. I think you don’t want him to pretend that he, to pretend he’s God. You want him to say, Well, actually not enough is known about this conditio or, Here are the options But in the end you want to say to the doctor, But of what you know, what do you think the odds are? Which way would you really go And in the end you want the doctor to plump one way or the other, as best they can. I mean that’s, that’s their job.

He said that, he said exactly that – that they didn’t know and they were looking and the research was purely to see whether the two weeks was better than the every three weeks. I think he might have said actually indications are showing that the two weeks is better, but again because I didn’t know, you don’t know what questions to ask initially, and I’m just sitting there like a nodding dog nodding at everything he says, saying, Yeah, yeah, clinical trial, that’s fine. I’ll sign it. And I guess that’s why they say you can go away and think about it. But I don’t, I just, there’s questions that I want to ask now that I’m further into it and perhaps feel a bit more confident. Because when you’re first diagnosed, you just want it gone and just say, Just start. Whatever you need to do, just do it now and get it gone. But now, I wouldn’t say I was completely casual about it, but I’m bit more relaxed and a bit more confident and want to ask, ask some questions about it to see what they mean about lifespan, or whether it’s relapse, or what, what it is.

Would you feel able to talk to them in between appointments? Is there someone you can talk to?

There is. There’s a Macmillan nurse there who I’ve got her direct line and I can just leave a message and she’ll call me back, and that’s no problem at all.

But I don’t feel I’ve got anything urgent enough to phone in between appointments, but I know she’s there. And I mean I have phoned if there has been something. I had an infection and that was very quick, and you phone the on-call haematologist and they just have you straight in to deal with it. But apart from infection, it can wait. It’s really not a problem. And she’s always about and she’s happy to talk.