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Rosamund - Interview 18

Age at interview: 64
Brief Outline: Rosamund is taking part in a large trial testing the effectiveness of screening for ovarian cancer. She is in the control group, so she has no screening tests but completes regular questionnaires.
Background: Rosamund is a university professor, with 3 adult children. Ethnic background/nationality' White British.

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Rosamund received a letter inviting her to take part in a large ten-year trial of the effectiveness of screening for ovarian cancer. The trial compares a control group (no screening) with two different types of screening. One screening group has a regular blood test plus vaginal ultrasound if the blood test shows any unusual results, or vaginal ultrasound on its own.
 
Rosamund has worked in research for many years and has personal experience of designing and running trials. In principle she is strongly in favour of randomised controlled trial research, and felt she had a moral responsibility to take part. However, she felt the leaflet which came with the letter did not contain enough information to enable her to decide whether to take part and so she asked to be sent a copy of the full study ‘protocol’ or detailed description. This took six weeks to arrive. In particular she wanted to know more about the possible discomfort of vaginal ultrasound and about the risk of being diagnosed incorrectly with ovarian cancer (a ‘false positive’ result), or being reassured that you do not have cancer when in fact you do (a ‘false negative’). She was also unhappy that there was no choice of appointment times outside working hours.
 
Once she had this extra information, Rosamund agreed to take part in the trial, because ovarian cancer is known as the ‘silent killer’ and it is important to find ways of detecting it earlier when it might be more treatable. She has known someone who died from the condition, and she herself has also had cancer in the past. However, at a personal level she was worried about being randomised to one of the groups having vaginal ultrasound and was relieved when she was told she was in the control group. She might have considered withdrawing if she had been allocated to either of the screening groups. Now that she has agreed to take part, she believes it is important to stay in the trial. As a researcher she knows how frustrating it can be if people drop out part-way through.
 
Taking part in the trial has involved filling in questionnaires about her psychological well-being, as the trial includes a study of how screening may affect quality of life and levels of anxiety. Rosamund was surprised that the questionnaire seemed to include a lot of questions on women’s sexual activity, and did not feel it was very well designed to reflect the things that are important to women themselves. She believes it is important that researchers involve lay people in designing their studies, and that the principles of trial design and randomisation are better explained to the public.
 
 

Rosamund got a letter about the ovarian screening trial.

Rosamund got a letter about the ovarian screening trial.

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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 o’clock 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.  
 

Rosamund supports medical research, but it depends how invasive the different interventions are....

Rosamund supports medical research, but it depends how invasive the different interventions are....

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Well, my first thoughts were that I was pleased that that this trial had been organised. Ovarian cancer is known as the silent killer, and the problem with it is, that by the time people have symptoms, it’s often too late to do anything, so this is clearly an area where some kind of effective screening could, in theory, prevent many deaths. So I was pleased that the trial was happening. And I felt that I ought to take part, that I had a moral responsibility to take part. However, my second thought was, “I don’t want to be in the groups that are having these particular approaches to screening.” And that’s quite interesting, because, as somebody who has actually, you know, organised trials myself, I know that the main problem with people refusing is actually amongst people who are randomised to the control group, who are dissatisfied and want to be receiving whatever intervention it is, and my attitude was different. I wanted to be in the control group [laughs] and not in the two screening groups. So I’m not sure what I would have done had I been randomised to one of the screening groups. I think I probably would have dropped out, and I would have argued to myself that since most people, as I’ve just said, most people who drop out drop out for the opposite reason, I would just be balancing numbers.
 
Can you imagine yourself in the situation in the future where you were diagnosed with something and how you would feel about having that decision?
 
Yeah. I would feel that I needed to check out the statement, “We don’t know which treatment is best.” And if that was really true, then I think I would say, “Okay.” It’s easier I think when, you know, what your - [sighs] well, no - I mean when the choices are between different treatments that are much the same in terms of physical side effects or inconvenience or whatever. If there was a big difference, as I felt there possibly was with the ovarian cancer trial, then I think it’s more difficult. You know, if being in one group means that you’ve got to go to hospital every month [laughs] and have something which hurts, as opposed to going every six months and having something that doesn’t hurt, then it is a decision with consequences.
 

She felt some possible disadvantages of taking part were missing from the information leaflet....

She felt some possible disadvantages of taking part were missing from the information leaflet....

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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. 
 

People who organise research have an ethical responsibility to give feedback to participants, but...

People who organise research have an ethical responsibility to give feedback to participants, but...

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So they’re not going to, they say in the information leaflet that you’re looking at twelve years from the beginning before there are any answers. They have sent out one newsletter which came last year, which is a couple of pages just saying, you know, how many people have been recruited and that recruitment had finished and how important the study is and so on. But it doesn’t give - well, you wouldn’t expect it to - give any more information than that. So, you know, I very much hope that the people who are organising this trial will communicate the results to the women who are taking part, at the same time as the results are published, because there have been too many occasions in the past of people actually reading the results of the study that they have been in and getting quite alarmed about them.
 
I think there is an ethical responsibility for people organising research to ensure that the participants actually do have this information first, because without them it wouldn’t have been possible to have it at all.
 
Can you remember if it said in the information anything about whether you would get information about the results?
 
It says that you will get information about the results, but it doesn’t say when. I mean it is quite tricky, you know, if you’re publishing the results in a, in a medical journal like the British Medical Journal. The timing of it is difficult and you can’t send the results out before the article is published. But there still must be, there are ways of ensuring that people do know what’s happening, and that they don’t run the risk of opening a newspaper or seeing an item on television which is reporting the results of the study and causing them consternation and alarm. That shouldn’t happen.
 

Rosamund does not think people should be paid to be in trials, but staff need to recognise that...

Rosamund does not think people should be paid to be in trials, but staff need to recognise that...

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I’ve said a bit about how I think the recruitment process could have been improved. You know, it was unnecessarily wearing, and I could have easily have dropped out at that point because, you know, there was a difficulty. It wasn’t actually possible to have a conversation with someone and fix a time that I could easily do. That wasn’t possible. It was a matter of returning letters, being sent another appointment which was, of course, always during the day. I mean this went on, it went on for several months and I can’t believe that there weren’t other people in my situation that, you know, there also probably were people who had to take time off work, even unpaid time off work, in order to be recruited into this trial. I don’t think people should be paid to take part in research, I’m not saying that at all, but I think there should be an awareness of the fact that you have to put yourself out to go through this process even if you’re in the control group. You know?
 

The questions in the ovarian screening questionnaire didn’t seem to be about things women...

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The questions in the ovarian screening questionnaire didn’t seem to be about things women...

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Well, the questionnaires - this is a, [sighs] another thing that I think is not entirely clear. There is something called a psychosocial study which is attached to this trial, but it’s called a quality of life study in some other places, so I’m not sure exactly what it is. The relationship between the trial and this other study still isn’t clear to me. I mean I sat down, you know, yesterday to read through everything, and I still didn’t really understand it. But in the control group, what you get is two questionnaires three and a half years and seven years after recruitment. And there seems to be quite a lot of emphasis in this study on women’s attitudes to sexual activity, which I find surprising, because it seems to me that if you’re looking at the effects of taking part in a trial like this then, for example, you know, being anxious about getting these high level blood test levels, or whatever, that’s going to have a general effect on your life, rather than necessarily a specific one. So I couldn’t quite understand why there were so many questions about sex, and not so many questions about the impact on one’s general level of well-being.
 
And do you know with the control group how they’re going to follow you up at the end? Are they just going to do it by linked records with your GP?
 
Good question. Not clear [laughs]. I imagine that yes, the main outcome is, is cancer, ovarian cancer-related deaths, so that’ll be, they’re not relying on the participants to give them that information. They’ll get that anyway.
 
But the outcomes to do with psychosocial morbidity, or whatever you want to call it, will be derived from the questionnaires, which is why it’s important that the questionnaires should be about the issues that women themselves consider to be important. And I noticed at the time that on the trial coordinating group there were no ‘consumers’, whatever that means. And also I think that this study would have benefited from having a sociologist involved, somebody who has experience in research in health and illness. But, you know, it’s easy to be critical. I’m very pleased that this trial is happening. I think it’s important to say that there should be large enough studies to answer any questions about these kinds of strategies for preventing important causes of illness and death.
 

Involving people in research can seem tokenistic, but it’s still useful to have comments on...

Involving people in research can seem tokenistic, but it’s still useful to have comments on...

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I mean it is almost inevitably a form of tokenism, but it can still be very useful just to have a few people who are not, who don’t have a vested interest in recruiting as many women as possible to the trial, who, you know, don’t have a vested interest in the questionnaires all being filled in completely without any kind of missing questions and this sort of thing. Just people who have got a common sense approach to what it’s like being asked to take part in this kind of research, and who can raise questions to which it would be helpful to have answers early on rather than having people, you know, turning round later on and saying, “Well, I don’t think this trial is very well organised, so I’m not going to take part.” Now I have no idea what the drop-out rate in this trial is, you know, whether twenty per cent of women in the control group are just not bothering to fill in the questionnaires because they think they’re quite silly [laughs]. I don’t know.  
 

Rosamund would not have agreed to take part in a study which did not use randomisation to make...

Rosamund would not have agreed to take part in a study which did not use randomisation to make...

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I think the attitude to being asked to take part in a trial should always be, “Yes, I ought to do it provided that the trial is well-designed and is going to answer an important question.” I think far too much research - and we haven’t touched upon this but it is a point I would like to make - far too much research is done in such a way that the question can’t be answered. And the advantage of a trial with randomisation is that you do have, you should have, comparable groups. So that in this trial the kinds of women who are in the control group are going to be the same kinds of women as are in the screening groups.
 
And therefore the answer to the question is likely to be much more reliable. And if randomisation were not used, if there had been some other method of allocating women to these groups, I would not have taken part. So if it had been some kind of matching in terms of history or, you know, social class or something, I would have said, “No, I’m not going to take part. If you do it as a randomised trial, yes, but not if you use some other kind of way of distributing people between groups.”
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