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22 March, 2005
The NICE Guidelines
A Frontline Club Discussion

This is an edited transcript ...

Mark Brayne:

Tonight’s event is very much about discussing a very specific set of scientifically grounded pieces of information. Stuart Turner who has been a leading figure in developing these guidelines will lead us off, and then hand over to Jonathan Bisson from the Cardiff and Vale Trust in South Wales. Pam Dix of Disaster Action will finish off the beginning of the discussions.

Stuart Turner:

What I’m going to do is four things. I’m going to start by talking about a personal history, I’m going to tell you some stories about me, briefly. I’m going to talk about how the evidence base has grown, how the guidelines have been developed and then I’m going to show four slides with some of the main points from the guidelines. They’re points taken from the printed version you’ve got in front of you. It’s just to emphasise because I think it’s worth doing that.

Then John, who chaired the group, will take over and talk about psychological therapies for Post Traumatic Stress Disorder and Pam from Disaster Action will talk about the perspective of the PTSD sufferer, the person with PTSD.

So let’s start. My story goes back to the 1980s and I could have put other things here as well; the Harrods’ bomb was quite a big event in my life because I happened to be in St Stephen’s Casualty when that happened and it also had implications for people close to me. But the Bradford Stadium fire I think is a really important event in the history of understanding trauma in this country and it taught us several things.

It was a huge disaster. It was a disaster in which politicians got a bit interested and that did quite a lot in the 80s, for those of you that remember the 80s, in terms of changing the scene. It was a disaster in which there was an organised police response, which was unusual at that point, and it was a disaster in which people started going round to the community and listening. They were knocking on doors saying, ‘Do you have any problems? Do you want to talk to us about them?’ That had never happened before. Now I know there are down sides to doing that but that disaster and the planning that emerged from that disaster were very influential in the way that I started thinking about my work.

Around the same time, I was also working with the Medical Foundation for the care of victims of torture. In the 80s I was a trustee but I was seeing patients there, and one thing I learnt from that was the importance of listening; that actually people could tell me the answers much more often than I could tell them the answers. They could certainly tell me about their experiences and it was very important to listen to their experiences.

Then one night, I was sitting in the Medical Foundation, which then was in the old National Temperance just by the Euston Road and there were lots of sirens. It was a very disturbed night, something was happening and I finished about 10 ‘o clock. I was really drained and on the way home I realised there was something strange going on at King’s Cross. That was the night of the King’s Cross fire, and then I got sucked in to organising the Health Service Response, working with Camden Council, to the King’s Cross fire.

So, a mixture of working with people who were survivors of torture and survivors of disaster and – well, what did we do? Well, as I recall, and I may be recalling this with the benefit of hindsight, what we did was we listened to people. We recognised that some people, but not all, had a condition called PTSD. We recognised that some people had other conditions, some people had no conditions. We listened to people’s stories and we recognised that in working with survivors we had to be prepared to focus on their experiences of trauma.

The instructions that we gave to therapists after the King’s Cross fire - [there were] people from a whole range of backgrounds and we hadn’t really had the chance to train them - but what we said to them was, ‘If you do anything, just focus on the event and go back over it and back over it and back over it because that’s the thing that is driving the problem.’

We said people need space and time. You can’t always do this in fifty minutes and I used anti-depressant medication for some people. So those were the things I was doing in the 80s and as you’ll see, some of those things still seem to be valid when I look at the evidence.

So what has changed? Well, a number of things have changed. First of all we now have a lot more evidence to go on. We have the scientific evidence of the randomised control trial (RCT). The randomised clinical trial is a well recognised and a well-used tool, which allows us to say, ‘this intervention, ignoring all of the other factors that might be relevant, this intervention does or doesn’t lead to a particular outcome.’

Now there are limitations in the RCT chiefly because you can’t always do it on the scale that you want, and it tends to be on rather specific populations. But as a tool, it’s very powerful. Then what happened was people started saying, well, there are a number of trials - can we join them together? So there’s the option of joining the numbers together to give a more powerful statistical analysis; and that’s the Meta analysis. There have been a number of improvements in trial design and I think another significant landmark was the licensing of two drugs for the treatment of PTSD.

Now some people might see that as a negative and some people might see that as a positive. I’m not making a value judgement here. But I think the marketing of those drugs has had an impact on the way people are treated in this country and we’ll come back to the drug evidence later.

So, NICE is the National Institute for Clinical Excellence and it has techniques for developing guidelines based on scientific evidence. It involves the establishment of a guideline development group – a group of people who know something about the field and a group of people who know how to analyse data. So it brings together different sorts of people to cooperate and I think that’s a very powerful junction.

When we looked at how we were going to set about our work we said we’re not interested just in knowing if a particular treatment works or not. In other words, is a particular treatment better than doing nothing? That didn’t seem very helpful. What we said was we’re interested in knowing if it works to a degree that makes sense as a meaningful result. So you might say it could work if it caused a difference in a scale of point one; but a difference in a scale of point one might mean nothing in a clinical setting. It might mean nothing to a survivor. What we had to find out was whether it made a difference that was sufficient to make sense to a survivor as a useful outcome of treatment. So we weren’t just interested in the statistical significance but in how clinically meaningful the result was; and we discussed that in some detail and set some thresholds.

Our aim was to apply the scientific evidence to treatment decisions - really to improve care; not for people in disasters, not for refugees, not for assault victims, but for this very particular group of people who do go on to develop PTSD and I think that’s important. The guideline focused on PTSD and was obviously restricted to those interventions that had been subjected to this sort of scientific technique. But there may be other treatments that work that haven’t been subjected to this technique. We don’t know that. But what we have to go on is the evidence that we do have and recommend treatments that have been tested properly. So that was the process.

Now I’m not going to go into any detail on the statistics, so don’t worry, but I thought I’d just show you some of the statistics that we had to pore over and we had lots and lots of these, I promise you.

This is a chart showing the results of a number of drug trials. What you can see on here is the Meta analysis so it’s joining together three different trials in one analysis. The three trials were all on this side of the line so the statistics all favoured drug over doing nothing. What we’ve got at the black diamond is the result of aggregating those data into one pooled result. What this analysis shows is that this doesn’t meet our threshold of a clinical meaningful result. So although the statistics favour the drug, it isn’t at a level that makes it a clinically meaningful result. If you treated someone with that drug, they might notice some change but it wouldn’t be very much and then you have to ask yourself, is it worth doing that, is it not worth doing that? There are some value judgements to apply, which we’ll come on to.

And then really, what I was going to show now are four slides just showing some of the main conclusions. As I’ve said, there are limitations to these guidelines. They’re only for PTSD and they’re only looking at interventions that have been looked at in a scientific way. But what it says is, debriefing should not be used, should not be the routine practice. The evidence doesn’t support debriefing. It says, in the early phase after a major incident, where the symptoms are mild then it may be reasonable to wait and see because [for] many people in that situation, their symptoms will gradually recover.

Now that isn’t to say that there aren’t other things that should be done. We know that support is helpful, we know that there are other things that wouldn’t necessarily be called treatments that might help people to [make] their natural recovery. I think what we’re saying here is that you don’t necessarily need to medicalise.

From audience:

Can I just say that I think the focus there is on single session interventions and I think often debriefing, which I know is a bit of a dirty word in some ways, but when it includes follow up, can be very successful. A lot of the research has shown that a single session debriefing is what’s gone wrong, in terms of the outcome.

Stuart Turner:

I’m sure we’re going to have a debate on debriefing at the end but let me just go on to the next slide. What the next slide says - what the evidence says - is if you have severe problems at the beginning then a multi-session treatment can be helpful. But the evidence says that treatment should be cognitive behavioural treatment. That’s the only treatment that stands out as being supported by the evidence for severe symptoms in the early phase.

The guideline says, importantly, everyone without exception, with PTSD should be offered the opportunity of active treatment. The guideline recommends two on the basis of evidence: one is trauma-focused CBT and the other one is a treatment called eye-movement desensitisation reprocessing – EMDR. Those are the recommended first-line treatments for PTSD.

What about poor drugs? Drug treatments, as we looked at them, were disappointing. Drug treatments for PTSD should not be used as a routine first-line treatment even in primary care, never mind in secondary care. This means that we need to rethink how we make accessible trauma focused CBT and psychological therapies in the primary care setting, which is going to be a big challenge I think, for the NHS.

Drug treatments may be helpful for a number of people including people who prefer that option. Some people don’t want to talk about it and they do want help. It’s perfectly fine; patient’s choice, user choice is a key element of any guideline. So they should be available in some situations and we say which drugs seemed to be the best. For children, the guideline says trauma focused CBT is really the only treatment that stands out in the evidence, and it should be offered to older children with severe symptoms in the first month and to all children with PTSD whose symptoms persist.

So that’s a summary of some of the main points in the guideline. I’m going to hand over to John and he’ll talk more about psychological treatments and he may pick up debriefing.

Jonathan Bisson:

I was just going to focus primarily on psychological treatments for established PTSD. I’m very happy for us to have a chat about debriefing but perhaps we can do that later.

I think one of the interesting things when I first came into looking at PTSD was that lots of different psychological treatments are used to treat it. That’s true of many conditions but certainly in the treatment of PTSD a lot of treatments were used and very few of them seemed to have a sound evidence base for their use. So when I first came into it, cognitive behavioural therapy was probably used as much as anything else.

Mark Brayne:

Jonathan, can I just ask you to briefly explain for the journalists in the audience, what cognitive behavioural therapy and EMDR, are?

Jonathan Bisson:

Cognitive behavioural therapy is a treatment that involves looking at an individual’s thinking. For example, cognitive is for thinking, so a cognition is a thought and a behaviour the action, that’s where the behavioural bit comes from. For somebody with PTSD a classical cognitive behavioural treatment would be asking them to think about the trauma and go through it in great detail again, so exposing themselves to something they’ve already been through. An analogy is somebody that’s got a fear of spiders and they may be asked to look at a picture of a spider, then see a small spider, bigger spiders and then eventually sit in a room with spiders and you’ve got it really sorted out then [If an individual tolerates this].

With PTSD, what we often do is gradually increase exposure to the situation the individual has been through. The cognitive side of that is that a lot of individuals who have been through traumatic events will have cognitions; thoughts that are distorted as a result of their suffering, for example. A very common one is individuals who feel guilty about things they think they should have done differently during the actual trauma, whereas in reality that’s not true; it’s a distortion. So cognitive behavioural therapy will often use techniques to try and help an individual challenge these distorted patterns of thinking.

Eye movement desensitisation and reprocessing is another, what we call, trauma focused therapy in that the emphasis of the therapy is on the traumatic event, but it’s done in a different way. So if you go for a session of EMDR you’ll probably be asked to sit opposite your therapist. You’ll be asked to bring a picture up in your mind about the most distressing part of the event and you’ll be asked to let your therapist know how that makes you feel. It might be something like, ‘I am out of control.’ You’ll be asked where you feel that in your body, so it may give you a butterfly feeling in your stomach, and then you’ll be asked to focus on those three things: the picture, the thought and the actual feeling and then the therapist will start moving their fingers from side to side and ask you to follow them with your eyes.

It sounds weird, doesn’t it? I thought it sounded really weird when I first heard about this but it certainly does seem to work for some people. The theory is that as you move your eyes from side to side and you think about these things they gradually get easier, That’s certainly the experience that I’m sure several of us have had who have practised this; that for some people it does help things to get easier. We don’t know exactly how it works but clearly there is an overlap between that and the trauma focused cognitive behaviour therapy.

Group therapy, I think that’s fairly self-explanatory but that uses different schools of psychological thinking to actually try and help people. Psychodynamic therapy delves a bit more back into the past and uses relationship issues, often from one’s childhood and tries to look at factors like that. In-patient treatment, well, psychological treatment, has been provided on an in-patient basis and is advocated as being best provided by some individuals on an in-patient basis. We’ve then got psychosocial rehabilitation, which is perhaps a psychological treatment for individuals with more chronic difficulties, hypnosis, marital and family therapies and then creative therapies like art therapy, drama therapy, which often involves expressing emotions and feelings through other media.

Within the NICE guidelines, what we found was that there was a paucity of evidence for several of the different groups that I mentioned there. So, for example, there were no randomised controlled trials of in-patient therapies specifically so we haven’t got that as a separate therapy, or of the creative therapies. There is just an absence of randomised controlled trials. But what we did find were trials looking at trauma focused therapies provided on a one-to-one basis and we’ve got the trauma focused CBT and the EMDR coupled in that grouping; then individual, one-to-one non-trauma focused therapies. So stress management and relaxation work would be classical examples of that. That would really involve perhaps listening to a tape that tells you how to relax; to tense up your muscles and then relax them down but not actually focusing on the trauma at all.

Supportive therapy, non-directive counselling - being available to somebody but not directing them at all and often not using anything to do with the trauma itself - psycho-dynamic therapies and hypno-therapy - we lump those all together. I’m sure we’d all agree that’s not an ideal lumping together but there was only one trial for each of these different things so it’s difficult to look at them separately.

And then finally we’ve got group treatments. There were a few trials that looked at CBT provided on a group basis, often to groups of ten people, sometimes to more than that. So those are our groupings and those are the scores. Stuart said we weren’t going to discuss statistics and we’re not, but the bottom line here is that the higher your bar is up the graph, the more effective you’ve been shown to be as a treatment. And there’s a slight caveat here; we only have the confidence that the trials actually give us. So [with] some of the higher bars, it may be that the true result is somewhat lower than that, just because of the variability within the trials that have been done. [Does] anybody want to hazard a guess at which are our top two? The A and the B came out just about equal – this is a measure of PTSD, the CAPS (Clinician-Administered PTSD Scale). I guess we’re all going to be guessing the same sort of things.

Well, just to keep us in suspense for a little bit longer there were two studies in there that looked at other therapies and you can see seventy-two individuals were included in those studies. So when we’re looking at these studies we’re not talking about very large numbers of people. The biggest number by far was the trauma-focused cognitive behavioural therapy. These are well-designed, randomised, controlled trials; one hundred and twenty-two in the EMDR group. In fact, those are the charts so the trauma focused CBT and the EMDR came out the strongest, and in fact there is no real difference between those two groups, even though the EMDR group is a bit higher. The stress management group came out a bit worse but still seemed to have an effect and the other treatments didn’t come out as well, and the group CBT came out somewhere in the middle.

What we also did was to look at if trials had compared one treatment with another treatment, which obviously gives us some idea whether one is superior over another. We did have some evidence for trauma focused CBT being superior to stress management and other therapies when they did a head-to-head trial against one another. There wasn’t really any evidence to show that there was a difference between TF-CBT and EMDR.

So I think the bottom line is that with our recommendations, we’ve been able to justify them through the literature that we’ve looked at, and at the first line are the trauma-focused therapies. And I think, in all honesty, it’s very difficult to put our hands on our hearts and say that one is superior to the other. If you really continue to analyse in more detail there’s a little bit more evidence in certain areas for the trauma focused CBT, but that may represent the fact that there are more people included in those studies at the moment.

These therapies, to be effective are usually provided over eight to twelve sessions, which I think is an important point, and the sessions usually take between sixty and ninety minutes. I think a lot of us advocate using slightly longer sessions when we’re dealing with trauma-laden materials or if we’re doing exposure work with an individual. Sixty minutes is often not enough to really go through the trauma and make sure that the individual is feeling that they’ve come down after having gone through what is often a very emotional session.

The non-trauma focused psychological treatments, we argue should not be routinely offered. Now that’s not to say that they are ineffective treatments. In fact there’s probably not been enough studies done yet for us to say definitively one way or the other whether they are effective or not. But I think one of the big arguments is that when we do have the existence of proven effective treatments, it seems logical to argue that we should be offering those to people that suffer from this condition.

So I think there are a few discussion points and I know we’re going to discuss things later. I’ve mentioned the top three ones there. I think the fact that the trauma-focused therapies do seem to fare better than non-trauma focused therapies on direct comparison suggests that there is a specific effect. It’s something more than just meeting up with people and chatting with them for an hour over ten to twelve sessions, whereas if you do better than having nothing at all you can’t really say that.

And I think there are several future directions and things that we need to consider coming out of the recommendations. There are really major training implications to train up people to provide these treatments that have been shown to be effective; and also to offer adequate supervision [to those] who are going to be providing them.
And then, I think there’s also the challenge of developing even more effective treatments in the future.

And with that, I’ll hand over to Pam.

» Click here to read part two ...

 

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