OK, I wondered if that was the case. But again is this because there are so few researchers and so little funds ? What is the process for targetting a particular result for a repeat study, where's the encouragement to do that ?
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BMJ comments on new PACE trial data analysis
- Thread starter charles shepherd
- Start date
OK, I wondered if that was the case. But again is this because there are so few researchers and so little funds ? What is the process for targetting a particular result for a repeat study, where's the encouragement to do that ?
Jonathan Edwards
"Gibberish"
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I think that sums it up very well.
Jonathan Edwards
"Gibberish"
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A good question. In rheumatology whenever something is reported everyone puts in a grant to do the same thing so they can get a paper too (they find some slightly different angle to make it publishable). I am not sure what has been happening in the ME field. It may be that lots of people have tried to replicate things and found they cannot but nothing is published because journals do not like negative data much. I think it may also be because there is no ME clinical/research community with youngsters wanting to publish papers for their CV. ME research tends to be done by relatively isolated groups it seems. So the issue of few researchers is certainly there. Funding I doubt is really critical. What people often do not realise is that innovative research tends not to be funded officially at the time at is being done. In order to get a research grant most times you actually need to have already done the research and know what answer you are going to get (because you have got it). You then get in some money, ostensibly for that project, and do the next bit which you then apply for funding for .... So when a research group has a new idea there is usually enough money to cover it in the kitty. The problem is that if the result is negative it fizzles out.
The problem is that this 'organic' way of doing research has probably got stifled in the last ten years because of much closer audit of what is going on. That is probably a disaster - and particularly for ME research which is just getting going. So we need to convince funding bodies for a more strategic approach to replicating interesting findings I think. That can be done, and some people have done it, but it needs a systematic approach that only a few research teams are really good at.
Thank you, very interesting reply. I ask partly to know what's going on in the ME field - and what would be a way forward with this to get the studies we need - but also because from my time in university research (a short time and a long time ago and not medicine) I just don't remember this sort of process at all.
Yes. One of the most insidious and objectionable pieces of propaganda getting around about patients is that we have to be 'educated' about our disease and how to manage it, by clinicians.
It would be high farce if it were not so serious.
No, I missed that. Thank you.
Esther12
Senior Member
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We may be speaking at cross purposes a bit, because I agree that some kind of inverse PACE is not a good idea. I'm talking more about criticising problems with PACE and the way in which results from it have been presented, and perhaps drawing attention to the many legitimate concerns that patients have.
Also, for me personally, I just don't like the sort of spin we've seen around PACE. It irritates me. I don't think it's good for us as a society to let people get away with that sort of thing.
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Esther12, I agree with you, I think what you say is right. I'm just so tired of thsi whole PACE thing. It just never goes away. Those media reports have really got on my nerves.
Take care.
Take care.
I tend to see PACE as a political rather than a scientific problem. There results are poor and the spin they put on them in papers unconvincing. The problem is they are good at PR and have a receptive audience.
I wonder if rather than new trials what we need is for the data behind the PACE trial to be made public. For example, what are the distributions of outcome variables - if they are multi-modal and skewed then the way the quote results is meaningless. Their twisting of the recovery stats was outrageous they got away with it in part because the support of the journal editor. But if we could get data for the recovery definitions in the protocol and for objective measures they would have a very hard job justifying how they published their results.
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Describing PACE as a political problem really sums it up well. I believe getting the raw data would be the best thing. Some (or all) of the trial was paid for with taxpayers money. Shouldn't taxpayers see the data?
I seem to recall that a previous freedom of information request for the trial data was refused for being vexatious. After appeal it was again refused, as it was stated that whilst it was no longer vexatious, the trial data wasn't easily accessible, too much work or something. Well, it looks like the data was nice and easily accessible this time to do the latest rehash of the PACE data.
So which is it? Do they have the data all in one place or not?
If they do, they could now fulfill the FOI request, or fulfill a new request.
If they don't, how could they have possibly done this new analysis of the data?
Either way, something doesn't add up. As usual.
I seem to recall that a previous freedom of information request for the trial data was refused for being vexatious. After appeal it was again refused, as it was stated that whilst it was no longer vexatious, the trial data wasn't easily accessible, too much work or something. Well, it looks like the data was nice and easily accessible this time to do the latest rehash of the PACE data.
So which is it? Do they have the data all in one place or not?
If they do, they could now fulfill the FOI request, or fulfill a new request.
If they don't, how could they have possibly done this new analysis of the data?
Either way, something doesn't add up. As usual.
Esther12
Senior Member
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Sorry to hear that. I hope that some things improve for you soon.
Kati
Patient in training
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For decades now, scientists have been told to each other it would be a career suicide to enter the ME field. Research that have been done have very little funding, or they have small sample which need replications. Moreover, very few specialists, the kind of clinicians who conduct research, care for patients with ME. Dr @Jonathan Edwards you are the first rheumatoloist I know who actually wants to listen. The rheum in my area, when sent a hard copy of the Norwegian trial, told me they had no time nor interest in caring for patients with ME (if I got a response at all). what is being thought in med school about ME is either inexistant or erroneous. Moreover, no medical profession embrace the disease, allowing specialists to refuse to see patients with ME
The blocks to research and to competent health care are significant and numerous. We are facing enormous stigma in society and health care, we are facing propaganda from psychiatrists, we are facing absence of funding. This downstreams to the researchers who would appreciate getting money for what they do, and a chance at feeding their family.
i am suggesting these are the major obstacles we are facing. Patients have been at it for 3 long decades. In contrast, only a very few physicians have accompanied us all these years. Until we address these obstacles, until these issues are discussed in medical and research societies, until a medical specialty will be assigned to us and until there is 50 millions of funding allotted to the disease for research, we are bound to continue on our (not so ) merry limbo way
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This.
We have, IMHO, already won the basic scientific and ethical arguments. But we are still being shafted so bad by the politics and PR machines.
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biophile
Places I'd rather be.
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I know that some patients view tackling the CBT/GET research as a complete waste of time which is a decoy that distracts away from the real issues. But challenging questionable research is just as important as promoting good quality biomedical research or following up promising leads from pilot studies. Imagine how much worse off we would be if no one bothered to critique CBT/GET and no one could explain what was wrong with it when faced with all the hype? People who critique CBT/GET and the associated models of CFS may have had extremely limited success in the current environment, but they still have made a difference which should not be devalued as meaningless.
I think an interesting contrast is with Fibromyalgia. I've looked a bit at the results for exercise interventions and although there seems to be a bit more of a response than with ME/CFS, the results still aren't great for an awful lot of patients. But as one leader of a Fibromyalgia group told me, every rheumatologist in Ireland she knows recommends exercise.
Developing the arguments and setting the stage is as important a step as any in the process.
[optimism on]
Don't be disheartened people. We have made huge progress in recent times, even if it is not immediately obvious, and with a bit of luck we will be getting some serious pay off for all our work and patience and suffering before much longer.
[optimism off]
Bob
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After giving it a bit of thought, I think a new trial for pacing would probably lead to disappointment, and we'd possibly be setting ourselves up to fail... I'll explain why...
I think the best we could hope for is that it might demonstrate that pacing is safe, and somewhat useful.
As others have said, pacing isn't a treatment, so I doubt if it would lead to drastic improvements in a trial, so the trial outcomes would probably be underwhelming.
Pacing is a symptom management tool that can help stabilise the illness, in some patients, and can make patients more comfortable. In the medium and long term it can lead to improvements in quality of life, and improvements in the illness itself in some patients.
In the pace trial, if i remember correctly, SMC recipients (i.e. all participants) were given basic instructions to avoid boom and bust, so all participants in the trial were pacing do a degree. And, by the time CFS patients enrol on a medical trial they've probably already learned to pace, either through bitter experience of relapsing, or because they've read some helpful info. In such circumstances, where all participants are pacing to a degree, it's difficult to assess the effectiveness of pacing.
Despite what the authors would have us believe, GET, as administered in the PACE trial, was actually a form of pacing, because therapists were instructed to 'adapt' the therapy if patients had a relapse, to "avoid difficulties". (You have to search the therapists manuals hard to find this, but it's there - see bottom of this post for the quote.) So GET was a form of pacing but with an emphasis on pushing activity levels upwards where possible. It's not like the old-style GET where patients were instructed to completely ignore their symptoms and push through regardless - the psychiatrists have learned their lessons about that. If it had been that sort of graded exercise in the PACE trial, then the results would not have been poor, they'd have been utterly disastrous.
I don't think that there is likely to be a lot of difference in outcomes between pacing and GET, in any trial that allows for GET to adapt to the patients' health fluctuations. But CBT/GET train/instruct the patients to interpret their symptoms differently, which makes trials vulnerable to response bias, esp for self-report outcomes. So CBT and GET are perhaps likely to always have better self-report outcomes than pacing which doesn't instruct patients to interpret their illness differently.
Pacing doesn't attempt to moderate patients' cognition, and it doesn't necessarily improve disability, but it allows patients to adapt to their illness and to feel more comfortable. For example, by using pacing as a symptom management tool, I personally have a choice between less activity (increased disability) with improved comfort (less severe symptoms), or more activity (improved disability) with decreased comfort (more symptoms). It suits me personally to always opt for less activity (more disability) and less severe symptoms because that gives me a vastly better quality of life, in terms of my subjective experience. So, in a trial of pacing, I would probably be recorded as being less active, more disabled, and less fit. Pacing would be recorded as having failed me. What most of the outcome measures wouldn't record is my stabilised symptoms over the long-term and the vastly improved subjective quality of my life, increased comfort, and my increased participation in (physically passive) cognitive activities (e.g. reading, writing, using the computer, making phone calls, watching TV etc.) (I still do physical activities, of course, but I don't place a personal emphasis increasing levels of activities for the sake of it. I increase when I feel it's safe to do so.)
It's not the outcomes of the PACE trial that are the problem for us. The outcomes almost all failed to demonstrate improvement after CBT and GET. There were no useful objective outcomes, and the self-report outcomes were marginal. They've even now quietly, but significantly, disowned their deconditioning hypothesis in this latest paper, because there was no change in fitness (step test) after CBT or GET. (Strange that they're being so quiet about it, seeing as the PACE trial was set up to test the deconditioning hypothesis.) And, of course, it was hypothesised that CBT would reverse the illness but it failed to do so when assessed via objective measures of disability - so there goes the fear-avoidance hypothesis too! But it's the huge amount of spin surrounding the publications that's the problem. And that's related to the hugely successful public relations machine that the psychiatric lobby (for want of a better term) have in place. They are hugely successful at making friends and influencing the right kind of people. That's what they do, and they do it wonderfully successfully.
Even if we had a successful trial of pacing, it would go unnoticed by the mainstream media, and the medical profession. It would get lost amongst all the other boring research papers that are published daily. And it would probably be underfunded and published in an obscure journal. The only people who would notice it would be ourselves. It could be useful, but it wouldn't change our situation drastically.
Whatever sort of trial were set up for pacing, we couldn't possibly compete with the hugely successful public-relations machine that spins out a line that CFS is a psychosomatic illness, related to fear etc. They'd probably set up some sort of competing trial, and ours would get drowned out by their public relations juggernaut.
It would also be incredibly complex and expensive to set up such a trial, if it was to be done well, and it might lead to resentment that yet more money is being wasted. Any patient organisation setting up such a trial would have a lot of explaining to do, when the money could have been spent on ground-breaking biomedical research instead. The MRC would get no thanks for funding it. They'd be accused of all sorts. AfME still haven't been forgiven for their involvement in the PACE trial. It's possible that we'd unwittingly set up another trial that was doomed to failure, for reasons that i've given above. The PACE trial cost $5m, and is still being analysed, 5ish years later. So you'd have to have some extremely motivated researchers to throw themselves into a rigorous trial of pacing, with possibly little to show at the end of it. It wouldn't be much of a career move.
I think our best approach is perhaps to continue challenging, to continue informing, to do as much as we can as a community to make our voices heard, and to continue to seek and support biomedical research. I think we're gaining traction as a community.
Although this latest debacle is annoying and frustrating, it has demonstrated one thing - that we are getting louder and stronger as a community - and we're all pulling together in the same direction, speaking with one voice, and slowly making a difference. Look at all the positive responses we've had to the latest media storm - The responses have come from all sorts of people - and not just from the UK - And they've been excellent responses. The journalists will surely have noticed our combined reaction. Many of us are now working on getting more responses published in various places - So we should see much more over the next month, or so. I'm sure that our protests will stimulate some journalists to now run some decent articles, and put some thought into it. There was a great article recently in medscape, bringing together the various aspects of biomedical research into ME, and I think we'll probably see more of that sort of thing in the future. Things are changing.
Just my views.
This is from the PACE trial's GET therapists manual, where it instructs the therapist to adapt to relapses...
I think the best we could hope for is that it might demonstrate that pacing is safe, and somewhat useful.
As others have said, pacing isn't a treatment, so I doubt if it would lead to drastic improvements in a trial, so the trial outcomes would probably be underwhelming.
Pacing is a symptom management tool that can help stabilise the illness, in some patients, and can make patients more comfortable. In the medium and long term it can lead to improvements in quality of life, and improvements in the illness itself in some patients.
In the pace trial, if i remember correctly, SMC recipients (i.e. all participants) were given basic instructions to avoid boom and bust, so all participants in the trial were pacing do a degree. And, by the time CFS patients enrol on a medical trial they've probably already learned to pace, either through bitter experience of relapsing, or because they've read some helpful info. In such circumstances, where all participants are pacing to a degree, it's difficult to assess the effectiveness of pacing.
Despite what the authors would have us believe, GET, as administered in the PACE trial, was actually a form of pacing, because therapists were instructed to 'adapt' the therapy if patients had a relapse, to "avoid difficulties". (You have to search the therapists manuals hard to find this, but it's there - see bottom of this post for the quote.) So GET was a form of pacing but with an emphasis on pushing activity levels upwards where possible. It's not like the old-style GET where patients were instructed to completely ignore their symptoms and push through regardless - the psychiatrists have learned their lessons about that. If it had been that sort of graded exercise in the PACE trial, then the results would not have been poor, they'd have been utterly disastrous.
I don't think that there is likely to be a lot of difference in outcomes between pacing and GET, in any trial that allows for GET to adapt to the patients' health fluctuations. But CBT/GET train/instruct the patients to interpret their symptoms differently, which makes trials vulnerable to response bias, esp for self-report outcomes. So CBT and GET are perhaps likely to always have better self-report outcomes than pacing which doesn't instruct patients to interpret their illness differently.
Pacing doesn't attempt to moderate patients' cognition, and it doesn't necessarily improve disability, but it allows patients to adapt to their illness and to feel more comfortable. For example, by using pacing as a symptom management tool, I personally have a choice between less activity (increased disability) with improved comfort (less severe symptoms), or more activity (improved disability) with decreased comfort (more symptoms). It suits me personally to always opt for less activity (more disability) and less severe symptoms because that gives me a vastly better quality of life, in terms of my subjective experience. So, in a trial of pacing, I would probably be recorded as being less active, more disabled, and less fit. Pacing would be recorded as having failed me. What most of the outcome measures wouldn't record is my stabilised symptoms over the long-term and the vastly improved subjective quality of my life, increased comfort, and my increased participation in (physically passive) cognitive activities (e.g. reading, writing, using the computer, making phone calls, watching TV etc.) (I still do physical activities, of course, but I don't place a personal emphasis increasing levels of activities for the sake of it. I increase when I feel it's safe to do so.)
It's not the outcomes of the PACE trial that are the problem for us. The outcomes almost all failed to demonstrate improvement after CBT and GET. There were no useful objective outcomes, and the self-report outcomes were marginal. They've even now quietly, but significantly, disowned their deconditioning hypothesis in this latest paper, because there was no change in fitness (step test) after CBT or GET. (Strange that they're being so quiet about it, seeing as the PACE trial was set up to test the deconditioning hypothesis.) And, of course, it was hypothesised that CBT would reverse the illness but it failed to do so when assessed via objective measures of disability - so there goes the fear-avoidance hypothesis too! But it's the huge amount of spin surrounding the publications that's the problem. And that's related to the hugely successful public relations machine that the psychiatric lobby (for want of a better term) have in place. They are hugely successful at making friends and influencing the right kind of people. That's what they do, and they do it wonderfully successfully.
Even if we had a successful trial of pacing, it would go unnoticed by the mainstream media, and the medical profession. It would get lost amongst all the other boring research papers that are published daily. And it would probably be underfunded and published in an obscure journal. The only people who would notice it would be ourselves. It could be useful, but it wouldn't change our situation drastically.
Whatever sort of trial were set up for pacing, we couldn't possibly compete with the hugely successful public-relations machine that spins out a line that CFS is a psychosomatic illness, related to fear etc. They'd probably set up some sort of competing trial, and ours would get drowned out by their public relations juggernaut.
It would also be incredibly complex and expensive to set up such a trial, if it was to be done well, and it might lead to resentment that yet more money is being wasted. Any patient organisation setting up such a trial would have a lot of explaining to do, when the money could have been spent on ground-breaking biomedical research instead. The MRC would get no thanks for funding it. They'd be accused of all sorts. AfME still haven't been forgiven for their involvement in the PACE trial. It's possible that we'd unwittingly set up another trial that was doomed to failure, for reasons that i've given above. The PACE trial cost $5m, and is still being analysed, 5ish years later. So you'd have to have some extremely motivated researchers to throw themselves into a rigorous trial of pacing, with possibly little to show at the end of it. It wouldn't be much of a career move.
I think our best approach is perhaps to continue challenging, to continue informing, to do as much as we can as a community to make our voices heard, and to continue to seek and support biomedical research. I think we're gaining traction as a community.
Although this latest debacle is annoying and frustrating, it has demonstrated one thing - that we are getting louder and stronger as a community - and we're all pulling together in the same direction, speaking with one voice, and slowly making a difference. Look at all the positive responses we've had to the latest media storm - The responses have come from all sorts of people - and not just from the UK - And they've been excellent responses. The journalists will surely have noticed our combined reaction. Many of us are now working on getting more responses published in various places - So we should see much more over the next month, or so. I'm sure that our protests will stimulate some journalists to now run some decent articles, and put some thought into it. There was a great article recently in medscape, bringing together the various aspects of biomedical research into ME, and I think we'll probably see more of that sort of thing in the future. Things are changing.
Just my views.
This is from the PACE trial's GET therapists manual, where it instructs the therapist to adapt to relapses...
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Kati
Patient in training
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- 5,497
Basically the tactic they, the british psychiatrists, the authors and the Science Media Center are using is bullying, terrorism and propaganda.