Feedback of trial results
Current guidance is that at the end of a trial the results should be made available to everyone who took part, if they want them. They should also be published so that the wider community can use them to guide decisions about treatment and care.
Most people we talked to felt strongly that this was important, and several gave examples of good practice. People were glad to see what their contribution had led to and what it would mean for health care in future.
After the trial Sue was sent a copy of the report and an easy-to-read summary. She was pleased...
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When the findings had been analysed they sent you the report with a covering letter saying that, “This is the report that we’ve made”, you know. “It was published in the British Medical Journal.” And it gave you an overview of what the results were, and then it gave you the actual, the report that was submitted to the BMA [British Medical Association]*, or whoever it was. I think - no it was the BMA. So that they, so they sent you, they sent you the medical report, and sent you an overview so that you understood any medical jargon or anything that was in it. So they just, you know, it was very clear what they sent to you, so you’ve, you know, you fully understood and, you know, you understood the results of the survey or the trial.
Was there anything in the results that surprised you?
Not really, because, well, because extra information helps you. You know, it was extra information in a straightforward way, very easy to understand, no jargon in it, you know - or if they did have some jargon in, they explained what, you know, the words meant. So it was very simple to understand, so it was good. So no, I mean it was almost like a foregone conclusion. You know, give you more information in a way that’s easily accessible and easy to understand, and it’s going to make it easier for you to understand it.
So, you know, I think it was. I mean, I’m glad I took part in the trial because, you know, it proves that it was worthwhile and hopefully now people will understand it, and they’ll be able to give people more information, and it will make other people’s decisions so much easier. And you just get a clearer way, some of them, you know - ‘Should I or shouldn’t I?’ or ‘What if I do? What if I don’t?’ kind of thing. It just clears it away and gets it clear in your mind about what you’re going to do next time.
*FOOTNOTE' The British Medical Journal is the journal of the British Medical Association.
At the end of the trial participants were invited to a big meeting where the results were...
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And when they came to the end of the trial, had they said to you that they’d send everybody the results, let them know what the outcome was?
Well, we had a big meeting about, about three or four years ago. And they were saying that the, you know, the results had come through and from what knowledge they’d found, certain drug companies were now changing some of their methods and going over to making, you know, the new type of tablets. I think a general feeling was that the new type of tablets they were using were more, more beneficial, you know, the sort of ACE inhibitors, that sort of thing. And also the, there was a lot of information about the cholesterol lowering, which was much more, I think it was more beneficial than they’d realised, it had more of an effect than they’d probably realised before, and that cholesterol lowering was a much more important aspect now than it used to be - because it had never really been sort of looked into in conjunction with lowering blood pressure. That was the first real major trial where it had been, been tested. So I think that was probably the, the major breakthrough.
Were you pleased to find out what the results were? Had you been --
-- curious about what --
Yeah, I was. Oh, yes, certainly, yeah. Yeah, I mean having taken part in it I was, you sort of, I don’t know, you feel part of the whole thing, so it’s interesting to know what they, what they found. And it’s also good to know that they, they now realise what an important aspect, as I say, cholesterol is. So that’s, yeah, it’s pretty satisfying.
Fenella was given a copy of the journal article reporting the trial results. It was rewarding to...
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I was very, very delighted and impressed when my psychiatrist told me at a follow-up appointment that I went to, that the paper he had written up had been accepted into the American Journal of Psychiatry, because I’d heard that, that it’s very, very difficult to get a paper published in there and that only the very best get stuff published. And I felt quite, quite touched that I was part of that process to help inform about a treatment. I hadn’t read the paper yet. So I was, I mean I think I was a bit nervous. But I was given a copy of the paper when it was published. And it was very rewarding for me to see that not only had I got better but also on paper that a whole group of people had got better. And it was evidence-based through the research. And it was published in a very eminent journal. And that for me felt like something quite special, because I knew I was then helping other people. And also spread the word about good treatment, because I knew then that other psychiatrists would be reading that, and thinking, “Oh, you know, this is something new. I didn’t know about it. This is really good news because before we thought people maybe didn’t get better.” Because traditionally BPD [borderline personality disorder] was seen as untreatable. But this ground-breaking research had shown that it was actually treatable. And this for me was quite important.
As well as finding it rewarding to see the trial findings, many people felt it was their right, and saw it as an important sign of respect and thanks for what they had contributed voluntarily. It was also seen as a way of encouraging people to take part again in future.
Feedback of results shows respect for peoples contribution. If they dont feel involved they may...
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It’s, it’s the feedback at the end that is really important to the person, because you’ve taken part free of charge without any benefit to you except for that your health is okay - I mean financial benefit - then one would expect a result at least at the end of it, to tell them, you know, “Thank you very much, you’ve taken part, and there’s nothing to worry about.” It’s, it’s a peace of mind that’s more important.
And it doesn’t take much really to --
-- do that.
No. I mean, I was, I think I was kind enough to them to take part in this and my time and everything, but that was the least they could do to feed back. I think feedback is more important, because that looks like you’ve taken part and, you know, that’s it - they’ve had what they wanted and that’s it, bye-bye, you know. That’s not good enough, you know.
Despite that, would you still take part in another trial if it was offered to you?
I would, I would.
And why’s that?
Because it’s of benefit to a lot of people.
Is that your main reason for wanting to take part, rather than any benefit to you personally?
Well, it, that matters as well, obviously. But, okay, if it’s benefited me, it’s benefited millions of other, other people and I’m doing good to the community. So I’m helping everyone else.
I think feedback is very important, that the person who’s taking part knows all along what’s going on and things like that, and have communication. Because if there’s breakdown of communication, then it’s not going to help the person who’s taking part, and they’re not going to encourage other people, and they’re not going to take part in it again. Because that’s very important I think, communication and feedback, most important two things.
Elizabeth pointed out that sometimes the results will show the new treatment or drug did not work as hoped. In this case people who have had high hopes that a treatment may help them, and may have experienced significant side effects, will need some support in understanding and accepting the results. They will probably find out one way or another through the internet, so it is better to make sure they get a full explanation and support from trial staff. On the other hand, those who were allocated to the standard treatment will be reassured to realise that they had avoided the problems caused by the new treatment.
It is important that trial results are explained to participants, whether they are positive or...
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I think if somebody has offered to take part in a trial, then I think at the end of the trial it’s very important that they get some feedback on the results, whether they’re negative or positive, and I think there should be support available for those people who’ve taken part in the trial so that they are able to cope with the results. So that if they have gone, for example, through six months’ chemotherapy, which a trial has shown has not been beneficial, there is a system in place where they are able to air their frustrations about the additional side effects they’ve had, and dealing with the results that maybe what they’ve been through, although it’s produced a result, it hasn’t produced the result that they initially thought it might do. Because everybody goes into a trial thinking they’re going to help medical science and they’re going to help pave a better treatment or regime for that disease, and whereas it may stop people going through a particular treatment and experiencing additional side effects, to have gone through it and not quite got the results you were expecting you were going to contribute to, needs support.
I think nowadays with the internet people are more than able to find the results, and actually if they find the results in the quiet and space of their own home, and they come face to face with it with no support or nowhere to go to get some support, that is more damaging than being told by somebody, “Well, look, these are the results. We understand that you might be a bit frustrated or concerned or whatever, you know. If you’d like to discuss theses issues, please do.” I mean, for example, if somebody reads a magazine, a cancer support magazine, and then they publish the results, you know, you can’t hide from it.
Or somebody is going to say, “Ooh, wasn’t that the trial you were on?” You know, they were saying that it didn’t show the effect it was going to be on. But on the other hand if, if somebody goes on a trial and it shows that it is of benefit, you know, they might want to know additional material about the facts and figures of it.
It can of course be difficult to understand complex medical and statistical information, though as Sue’s experience (above) suggests, trials can provide an easy to understand summary as well as the full results. It was recognised as important to give people a choice, because, as Julian, said some people would rather not know about “the technicalities of obscure and maybe worrying things”. However, several people who wanted to know either could not remember being told whether they would be given the results, or felt it was something they actively had to ask for, rather than something that would be automatically offered as a choice.
He doesnt remember being told if he would receive the results. He asked to see a copy, but not...
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There was something else I was going to ask you about, whether you’d remembered whether they said anything to you about whether you’d get the results of the trial at the end.
I [sighs] I don’t remember. I actually asked to be given the results of that, just because, because I was curious, yes? So.
Do you think it’s something--
So if it’s published, then I would like to have a copy of that for sure, yes.
Do you think it’s something that ought to happen anyway, automatically, that results should be given to participants?
They should have an option. Maybe not everybody would think about it. I, it was obvious to me, again because I was a scientist, and, you know, and I knew this research would be published, and that’s why I asked. I mean, for somebody who’s not familiar with research maybe there should be a tick-box which asks them if they want a copy of the actual final outcome of it.
Merilyn would like to know how the trial is going, but she hasnt asked. She doesnt think she...
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Did she or anybody since say to you whether they would in the long term let you know what the results of the trial have been?
No. [Laughs] I’m very tempted, every year that they ring me up I’m very tempted to say, “How’s it all going? Is everybody alive still?” It’s not the sort of thing you ask really [laughs], and they wouldn’t tell me if I did ask that, so I never ask it. But of course the trial goes on. I think I would probably ask that sort of thing at the end of the trial because it’s actually a ten-year trial and I’m only in the fourth year now, so it’s quite early on in the trial.
But as I say I get very tempted to ask [laughs].
And you’d like to know?
I would, I would, I would. Yeah,
But probably a few more years towards the end of the trial, because obviously four years is quite new.
Yep, yep, yep. But as far as you know there’s no formal arrangement to let you know at the end of the trial?
It wasn’t something that was offered?
Do you think it’s something that ought to be offered up front to people, that you’ll get the results of the whole trial later on?
I think it would be nice, but maybe somebody else wouldn’t want to know, but I think it would be nice for it to be offered if somebody, you know, does want to know.
So you could, like tick a box on the consent form or something?
Anthea always asks lots of questions about how the trial is going, but thats a personal choice...
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As a person I would like more. I would like more information on the results. Perhaps that’s the type of person I am. I like to know results. Like I said earlier, I worked in research, and the results to me are quite important. Some people wouldn’t want to know the results. My husband’s one of these people that, you know, “Okay that’s what you’re going to do, so carry on and do it.” I’m a bit like a dog with a bone really [laughs]. I like to, I like to know how things are working, and I do ask, I do ask those questions. My husband sort of says to me, “You always want to know the ins and outs of everything.” I said, “Well, it’s my body. I’d like to know where we go from here. I like, I’d like to know what the results are.” And they’ve been, especially on this trial, they have been very, very good, and I know that I am the only one that has gone more than six weeks. So…
They are very open about this trial.
Giving you feedback as you go along.
They are giving me feedback because I, because I’m asking. I think if you’re not asking, then perhaps you wouldn’t be getting that information.
As Merilyn and Anthea explained, they wanted to know how the trial was progressing while it was still happening. However, incomplete results can be misleading. Researchers need to analyse all the results and it can take a long time to get to reach a final, reliable analysis. (See also ‘Funding and publishing trials’).
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.
However, some types of information can still be provided, which can help maintain people’s interest and motivation.
The research nurse shared preliminary results with them and told them about presentations he was...
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.
Fenella suggested that sending regular postcards to trial participants could be built into the funding for a project. Joanna also noted the importance of making sure research budgets included the cost of feedback.
Not all patients will be able to read an academic journal article, so other ways of presenting...
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It’s very interesting that you got a copy of the paper. Did you ask for that or was it sent to you anyway?
Well, it wasn’t automatically sent to me, but it was offered in the sense that my psychiatrist did tell me at one of my appointments that it was going to be published, and he did tell me about the results, very basically talked to me about the results, just to inform me. But I - and, you know, and he said to me did I, asked me if I wanted to see the paper and I said, “Yes” and, you know, and then, then I was, you know, given a copy. But I am also very aware that there are a lot of people who do take part in trials who never ever get to hear about the final outcomes, and also if the papers are written up and published, never given a copy of the clinical paper that’s published. And there are various reasons for that. One may be that, that the, it may be assumed that the patient doesn’t have enough knowledge to understand what a clinical paper is saying in terms of jargon and the way the statistics are presented. The other may be, of course, that, you know, clinical journals traditionally are held in the privy of medical school buildings or hospital libraries or, you know, online. Patients aren’t going to hold the privileged ATHENS number to get access to the journal.
So it, it is difficult. And if a patient - and some patients may also have this fear of contacting somebody, you know, like the great surgeon, surgical professor or, you know, the top-notch cancer specialist type thing, when actually they’re human beings just like us and, and they use our information. So I’m, I’m very aware that that happens.
Do you feel that there ought to be a responsibility on the part of people who run trials to share the results with people?
I feel very strongly about this. One of the things that I do is I work with the Mental Health Research Network. And one of the regional areas, the north London hub of the network is, we’ve got, you know, I do work with, with them, and I’m very, very proactive in promoting the whole issue about discussing the outcomes with trial participants. In fact, I was discussing recently with one of the research professors, who was doing a trial which had a six-month gap in between when they did their first interviews and their second lot of interviews. We were discussing how they can maintain contact with patients and keep them in touch with it, without it being too formal. So instead of them getting a bland letter through the post saying, “Dear Mr Bloggs, how are you? We’re just checking you’re still participating”, how can we - and, you know, and keeping in touch right until the very end of the trial, and then obviously keeping in touch thereafter.
And one of the ideas we came up with was about a postcard. You know, you get a lot of junk mail in the post and these postcards that come in from companies selling themselves. Well, I had this idea that a postcard could be designed and it may be, the cost may be sponsored or incorporated into the trial cost. If it’s a drugs trial, the pharma company could sponsor that. If it’s a non-drugs trial, it could be incorporated into the costing. And this would be a really nice, bright coloured card, and it would just be pre-printed with a picture on one side and on the other side the researcher could just write a little handwritten note to that person. And then put it in a, a normal plain envelope, you know, and post it to all the trial participants.
And just basically keeping in touch with them and sending them a card every, maybe every eight weeks, right up until the very end. And then at the very end having a meeting to say, “This is what the outcomes were.” And this is kind of something we’ve taken on board, because it’s incredibly important not just to get people onto a trial, but to have respect and to share the information and the outcomes at the end of the process. And make it accessible information, so not just also dishing out a clinical paper that’s out of some journal that may be out of the reach of many, you know. So, you know, obviously arranging a talk or a discussion or an evening where people can come and just have an informal question-and-answer session and a brief presentation about what happened.
It should be easier for people to get the results of trials, and researchers should make sure...
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And have they said to you if they’re going to let you know what the results of the trial are?
Well, not really. And that’s something that I also find very depressing, actually. Because again in the case where my husband was on a trial, they’d been trialling a particular drug for quite a long time on a European basis, and then they’d moved into just trialling it in one London hospital, but the European trial had pretty much closed, come to an end, and was being reported on. And I actually asked for the results of that, and I was told at the trial hospital that, well, they didn’t quite know when they’d be coming out but, yes, of course, possibly something could happen one day. I actually asked my husband’s consultant personally in a different hospital, and by return of email he sent me the results. They were there, they were possible, they were available, and they were not given automatically. And even when asked they were not exactly withheld, but it wasn’t made easy.
And that I do feel - I mean I don’t think my husband could have cared a pin what the results were - but I wanted to know. And in the ovarian one I certainly would like to know, because there are, there’s obviously, I mean, you know, plenty of opportunity for me at some later stage to be told I must be checked. And whether or not the blood test or the scan are a better way to do it, I would be very interested to know.
As far as the professionals are concerned, I think they do need to think very carefully about the problem that, yes, a lot of medical advance comes, has come through military sources and originally the soldiers needing one form of cure or another. But we aren’t numbers. We are individuals, who need to be taught to be intelligent about what we are doing, so that we can collectively be politically more sensible about our whole medical world. And I think that means they have to be much more careful about consent forms, and information about trials, and giving results back and discussing, and making sure that the trial builds in the funds for that - because it’s not a big amount of money that’s needed, but trials are always short of money. And I could never talk to the research nurse on [husband’s] trial because he was always too busy. He was sweet and very nice, but he was run off his feet, because there wasn’t enough money. And it isn’t a big amount of money needed to talk to people. So, you know, build that in to your funding.
As well as getting overall results from the trial, people were keen to know their own personal results. Julian was also interested to know how other patients in the trial were doing – several people said they enjoyed meeting other patients in the trial, but others had little contact.
Julian opted to get copies of any letters to his GP, and asks for updates on his own test results...
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Feedback of results. Did they tell you when you first joined the trial whether or not they were going to share the results of the trial with you?
I don’t remember. I mean, I’ve always asked about my results and I’ve asked also about the results of the trial in general. And I can’t remember whether I was told explicitly, given a promise, that I would be told about the results.
Yeah. But it’s tended to be you asking questions rather than sort of being given a regular up-date or getting a letter?
It’s hard to know. I signed up for an option called patient copies of letters to GPs. Anyway, every month when I go for my talk with the people at the hospital that looks after me, a letter is written by the doctors I’ve seen there. It goes to my GP, and a copy of that letter comes to me, so in that sense I always get an up-date on my own case.
I think anyone in a phase one trial should be told what the general results of the trial are. They should be involved. Their interest - and they have an interest, I’m sure, almost always, in how the thing as a whole is going, what contribution they’re making to medical knowledge and the well-being of other patients and they should be told.
Do you ever meet any of the other patients involved?
Well, in two ways, both a bit limited. So when you’re on the ward when you’re first starting the trial, you obviously chat with the patients in the other beds, but often they’re involved in other trials. But anyway, that’s interesting to talk to them. But then there was one other man with prostate cancer who was also a BRCA mutant who was put in touch with me. I was asked would I be willing to talk to him. I said, “Yes, of course.” So I’ve chatted with him on the phone several times, and I’m interested to know how his case is going and he’s interested in mine. I would actually quite welcome a bit more contact with other patients in the trial. I can see it has a potentially a good side and a bad side. You might want to just forget about all these woes. But I’m certainly interested. So few people, I think he and I are the only people with the relevant mutation and prostate cancer that have been involved in the trial. So we’re unique specimens.
And I think the drug has benefited him as well. He had a much more advanced disease than me.
A few people said they were interested only in their own results, not wider trial results. However, some people reported problems getting their own results. Danny was particularly upset at the way one medical researcher would never tell her what her blood pressure measurement was. She found this patronising.
When Danny's blood pressure was monitored during the trial, one doctor would never tell her the...
So it’s a blood pressure trial, one of the things was your blood pressure got taken. And it got taken lying down three times in a machine that people who have their blood pressure taken probably know, their doctors have got one. It prints out - like Tesco’s - it prints out the blood pressure and they take three. There’s a little gap between. I don’t know why, if it’s because it’s high and they wait. I don’t know why. But you lie there and you have your blood pressure taken, and they take it three times, and they take your pulse which this machine reads as well. Then they ask you to stand up and they do the same again, and the blood pressure is different. Now when the doctor was doing it I’d say to him, “What is it?” And he’d say, “It’s all right.” Well, that’s not the answer to that question, “What is it?” “It’s all right.” And I’d ask him again, “What is it?” “It’s all right.”
Now, it’s my blood pressure [laughs]. I didn’t say that to him, but it’s my blood pressure. Why does he see fit to not answer my question and to tell me it’s all right? Because if I’m monitoring my own health, I need to be aware of what he considers all right is, and I know my historic blood pressure much better than him. And it’s not all right for me to not know, because I’m not up there because I’ve got nothing else to do.
Anyway, so that sort of irritated me a bit, and said rather a lot to me about [sighs] the difference between a bedside manner that he needs to have when I might be being looked after, and they might have decided not to tell me things that might worry me or not, and me being there in my own time giving them my body to write notes about and not tell me. I mean, I just used to sit and read the file as they went out of the room to get something or came back or something like that. I would just sit and read the file, knowing full well that I could, and they’d left it, and I could read it anyway. But, you know, I don’t want to think, “I’m having my blood pressure taken - as soon as he gets out of the room I’m going to look at it”, you know? But what’s the big deal? Anyway, that was strange, and I found it irritating, because every time I went back I thought, “Well, he’s not going to tell me, you know. Why not?”
There’s a different way of dealing with people when, as far as I’m concerned, I’ve been asked to come and give something. I’m coming to give it knowing what I’m going to get out of it, which is a little bit of health monitoring, a little bit of - well, there’s all kinds of things. But there’s some kind of mismatch between me, the research. I don’t know. I don’t want to say guinea pig because I didn’t feel like a guinea pig, but basically I’ve subjected myself. I am not being cared for by the doctor. I am being used, and I don’t mean that in a pejorative way at all. I’m being used, and I believe with hindsight there’s a different way of dealing with people like me. I’m not a patient. I’m entitled to know the results of everything that is written down about me without taking issue and saying, “But I’m right. I’m entitled to see my file.” I suppose I was a subject of the trial, but I became an object of the trial. That’s what, and as a subject I would have felt there was a two-way thing, and as object I was just getting done to by them. That’s what, and it was sad, really. It was sad.
Last reviewed September 2018
Last updated July 2011