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NICE guideline for ME/CFS is unethical – Dr Diane O’Leary, Kennedy Institute of Ethics | 23 August 2

A.B.

Senior Member
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3,780
My point is that if it takes that long for an opinion to be accepted it is clearly an opinion, not a fact. So those who seek to do due diligence and establish the consensus view may well not get to see that it might be crucial.

The psychotherapy field might have a different culture along the lines of "if you can't eliminate bias, demand that treatments have larger effect sizes than what could be explained by bias alone, and make sure the control group has a treatment of similar intensity and contact hours". I'm not getting the impression this is working particularly well for them though, presumably because bias related to subjective reporting can vary a lot. Better to eliminate it outright, but that might be expensive and difficult when it comes to psychological conditions. In ME/CFS it's not overly difficult to measure real world functioning semi-objectively with daily step counts, CPET, etc. In depression this is probably a more difficult problem, and in other psychological conditions even more so.
 
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Jonathan Edwards

"Gibberish"
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5,256
Its self evident enough that quote, that especially science journalists, should be all over it.

So why is it not self-evident to David Tuller? Or James Coyne?
The reality is that it is not self-evident.

I really don't think that picking one reason over another why PACE provably stinks, when there's smelly fish in the BPS school, is a good enough explanation why journalists could take the stance...

But that is where the journalists back off - and rightly so. It sounds as if there is some prior prejudice against the idea being tested. Maybe there is good reason for such prejudice but it immediately lets everyone off the hook. The Lancet can say that the objection is to the conclusion not the methods. Nothing new here, let's move on...
 
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It is something on which one has an opinion. I see the situation as pretty black and white but, as I say, remarkably few people have agreed with my main reason for thinking that.
I find that rather scary, disturbing. Does that suggest there may be many more unblinded clinical trials, past an present of all kinds, purporting to deliver evidence based results from subjective outcomes? I hadn't realised your observations were not accepted as a gold standard for clinical trials. To me, once you pointed it out, it just seems basic common sense, and I know I'm not seeing this through rose-tinted specs. It's just fundamental.
 

Large Donner

Senior Member
Messages
866
But that is where the journalists back off - and rightly so. It sounds as if there is some prior prejudice against the idea being tested. Maybe there is good reason for such prejudice but it immediately lets everyone off the hook. The Lancet can say that the objection is to the conclusion not the methods. Nothing new here, let's move on...

Then that's just the Lancet building a straw man because as I said in my earlier post....

Aside from that how about changing protocols, dropping objective measures, refusing data release, connections to the DWP and insurance industry, denial of the existence of the value of tests like the 2 day CPET test.

We cannot be expected not to present the multiple evidences of why the PACE trial methods stink because others may misrepresent our argument as being based on predudices surrounding the conclusion.

Anyway which conclusion are we talking about? The original protocols based one or the one wherby they changed the recovery definitions halfway through the trial?

Perhaps we should be asking the Lancet that now, what exactly do they consider to be the actual conclusion?
 
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Jonathan Edwards

"Gibberish"
Messages
5,256
I find that rather scary, disturbing. Does that suggest there may be many more unblinded clinical trials, past an present of all kinds, purporting to deliver evidence based results from subjective outcomes? I hadn't realised your observations were not accepted as a gold standard for clinical trials. To me, once you pointed it out, it just seems basic common sense, and I know I'm not seeing this through rose-tinted specs. It's just fundamental.

Yup, it is rather scary. From what I gather there are thousands of duff trials out there in psychotherapy, probably nearly all of them. My view would, I think, be taken as self evident amongst physicians and clinical pharmacologists but it seems that in a psychiatry world where the book on trials is written by someone who has admitted they do not understand my argument things are different.

Yet, as you say they are fundamental in ordinary layman's terms. You do not assume that people have irrational ideas about their health and then test how much better they are by asking them what they think about their health when they know they have had the treatment that is supposed to make them better and it would sound mean not to say they are. Translate that into methodolospeak and you do not do unblinded trials with subjective outcomes and certainly not when the treatment is like this.

And to add to the fuzziness of all this, remember that although that last bit was obvious to me, the enormity of its common sense application to PACE did not occur to me until Esther12 pointed out just how absurd the whole thing was.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
"Aside from that how about changing protocols, dropping objective measures, refusing data release, connections to the DWP and insurance industry, denial of the existence of the value of tests like the 2 day CPET test."

But apart from dropping objective endpoints, which is the subjective bit I was focusing on, none of those factors would negate an apparent efficacy result from the first PACE paper. NICE has no right to take any of that into account. Other people maybe should but NICE has to go on evidence. They are wrong because the evidence is not there, but that has nothing to do with the DWP. And the value of CPET tests is very controversial. It is a red herring and NICE have every right to stop listening to red herrings. This is is a matter of persuading people, not blowing off steam.
 
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If failing to walk was due to worse health, we'd expect to see lower scores across the board for non-walkers.
I'm not so sure on that. The problem with perceived physical function is there seems to be a pretty perverse correlation (if it can even be called that) with actual physical function. There are all sorts of instances in the PACE data where perceived improvement in PF much exceeded actual. So it might also follow that the perceived PF figures might well exceed what might otherwise be inferred by dropping out of the actual PF test.
 
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To me @Jonathan Edwards case against PACE because is both unblinded and has subjective primary outcome measures seems blindingly obvious. There is such an enormous risk of placebo effect, therapist effect and, in the case of PACE, brainwashing, that the subjective outcomes are meaningless. Whereas in a double blinded drug trial, subjective outcomes are OK because the blinding eliminates these effects.

I think the problem is perhaps that most trials of psychotherapies are done on patients with psychological problems which don't have physical things that can be measured, and nor is blinding possible, so the practice has become established that unblinded trials with subjective outcomes are acceptable, since there's nothing objective that can be measured. This doesn't make these trials valid, but it does provide the excuse for continuing to do them. Perhaps this is why James Coyne objects to this argument - he is a psychologist, and accepting this would invalidate his own research.

On the other hand, extending this practice to trials of psychotherapies for physical illnesses where there are objectively measurable outcomes possible seems to me inexcusable, particularly when the therapy is designed to influence the way patients answer the questions.
 
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I am very disturbed that the perpetrators of the PACE fiasco are extending their dreadful CBT practices into other serious physical illnesses. I read today that Acceptance and Commitment therapy, which from what I've read is a particularly poisonous lot of hocum and completely unproven, is to be trialled for patients with Motor Neurone Disease. Having witnessed a close friend suffering and dying from that dreadful illness recently, I would have been appalled if she had been asked to participate in such an experiment in her last months.
 

Large Donner

Senior Member
Messages
866
But apart from dropping objective endpoints, which is the subjective bit I was focusing on, none of those factors would negate an apparent efficacy result from the first PACE paper. NICE has no right to take any of that into account. Other people maybe should but NICE has to go on evidence. They are wrong because the evidence is not there, but that has nothing to do with the DWP. And the value of CPET tests is very controversial. It is a red herring and NICE have every right to stop listening to red herrings. This is is a matter of persuading people, not blowing off steam.


I understand some of those points but we are jumping back and forth between what NICE should take into acccount and your point here...

the media have not been more helpful is because they perceive that ME/CFS advocates are all singing from different hymn sheets so that they cannot hear a clear tune.

....and also what the Lancets position on PACE should be.

Also in relation to the 2 day CPET when i said this....

Aside from that how about changing protocols, dropping objective measures, refusing data release, connections to the DWP and insurance industry, denial of the existence of the value of tests like the 2 day CPET test

do you think......

NICE has no right to take any of that into account.

Surely NICE is supposed to consider all the evidence not just the PACE trial conclusions wherver they stand now that the original protocols show a null result.

For the purpose of clarity:

The Lancet is operating on the principal of a strawman argument.

The media are cowards if they are not just stupid.

NICE can either use PACE to say the conclusions are meaningless because they are subjective, or stand by subjective conclusions and say the real original protocols definitions have proved zero efficacy. But they probably wont.
 
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A.B.

Senior Member
Messages
3,780
Maybe what we need is a provocative paper that shows how easy it is to create the illusion of effectiveness merely with lack of blinding and subjective outcomes. A trial that's a bit like the joke about CBT for car engine problems. The asthma medication paper that's sometimes cited in this kind of discussion is pretty good but it only illustrates very short term biases in self reporting.

But wait, don't we already have papers like these thanks to CBT/GET proponents?
 
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And in terms of reviewers for journals I had to fight hard to resist the suggestion that I should remove the argument because it would make most psychologists' research appear a waste of time. David Tuller disagrees with me on it - amicably. I think Tom has disagreed with me on it. I am pretty sure James Coyne has disagreed with me (he may have been one of the reviewers!). Important advocates behind the scenes have disagreed with me in personal conversations.
I'm interested by this. Are you saying the people in question don't consider the combination of open label trial, together with only subjective endpoints, to constitute a flawed methodology? Or do they agree it is flawed, but disagree on how significant a flaw it is? I'm really interested to know their rationale.
 
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To me @Jonathan Edwards case against PACE because is both unblinded and has subjective primary outcome measures seems blindingly obvious. There is such an enormous risk of placebo effect, therapist effect and, in the case of PACE, brainwashing, that the subjective outcomes are meaningless. Whereas in a double blinded drug trial, subjective outcomes are OK because the blinding eliminates these effects.
The very fact that good trials go to all the trouble and expense of double blinding when the primary outcomes are subjective, speaks for itself how important it is - they wouldn't do it otherwise. So how can others say it is not? Genuine question, to anyone who has an answer.
 

GreyOwl

Dx: strong belief system, avoidance, hypervigilant
Messages
266
You do not assume that people have irrational ideas about their health and then test how much better they are by asking them what they think about their health when they know they have had the treatment that is supposed to make them better and it would sound mean not to say they are.
Using subjective reports of improvement from people who are presumed to have irrational ideas about their health would seem to be illogical.
 
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2,391
Location
UK
So why is it not self-evident to David Tuller? Or James Coyne?
The reality is that it is not self-evident.
In his blog post "Trial by Error, Continued: More on Graded Exercise from Peter White and The Lancet", 28 June 2017, at http://www.virology.ws/2017/06/28/t...ded-exercise-from-peter-white-and-the-lancet/, David Tuller says:-
This new article exhibits the range of problems found repeatedly in this body of research, including the reliance on subjective outcomes for an open-label trial, unusual outcome-switching, and self-serving presentations of data.
[My bold]

Is he saying something he does not believe in here? Or converted by the time he wrote this? Or tacitly "quoting" what others have said?
 
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But apart from dropping objective endpoints, which is the subjective bit I was focusing on, none of those factors would negate an apparent efficacy result from the first PACE paper.
Nonetheless, the associations and investments of the researchers should be a red flag. If PACE were a trial of smoking instead of psychotherapy, and the ties were to large tobacco companies instead of large insurance companies, would NICE really not bat an eye at a claim of objective data showing that smoking more results in better health?

NICE has no right to take any of that into account. Other people maybe should but NICE has to go on evidence.
But NICE fails to take into account things which it should, and takes into things which it shouldn't. The primary factor in determining how they evaluate the evidence seems to be political. Hence we should be approaching NICE in a political context if want to ensure that they evaluate the evidence appropriately.

And the value of CPET tests is very controversial.
How so? The CPET has been a mainstream exercise test for something like 60 years now. In the US, a low score on a maximal CPET is proof of cardiovascular-related disability. In the Netherlands, it had the same effect for me, with two different agencies, including in getting a passenger disabled parking permit, which is bloody hard to get here.

The two-day version for ME patients may be relatively new, but even the BPS lobby has trouble arguing with it. Instead they just ignore it, hence there doesn't seem to be any controversy coming from that direction either.

I understand some of those points but we are jumping back and forth between what NICE should take into acccount and your point here...
Basically different audiences are best informed and persuaded by different arguments. NICE needs a politic incentive to evaluate the evidence appropriately, and the media need a coherent story to tell. Medical journals need a disincentive to give their buddies from uni or other sensationalists a carte blanche to publish ridiculously flawed papers.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
I'm interested by this. Are you saying the people in question don't consider the combination of open label trial, together with only subjective endpoints, to constitute a flawed methodology? Or do they agree it is flawed, but disagree on how significant a flaw it is? I'm really interested to know their rationale.

I wish I knew. I think most of them are conflicted. They know there is a problem but find it too uncomfortable to confront.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
David Tuller says:-

This new article exhibits the range of problems found repeatedly in this body of research, including the reliance on subjective outcomes for an open-label trial, unusual outcome-switching, and self-serving presentations of data.

Is he saying something he does not believe in here? Or converted by the time he wrote this? Or tacitly "quoting" what others have said?

David does now agree. My point was not so much that he ever disagreed with the criticism once raised but that it was off his radar because everyone seemed to think it was standard methodology and he has always felt other issues were more egregious.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
The primary factor in determining how [NICE] evaluate the evidence seems to be political. Hence we should be approaching NICE in a political context if want to ensure that they evaluate the evidence appropriately.

But in your previous comment you rightly point out that they are closing their eyes and ears to the politics! As I see it they have found some studies that purport to show benefit from CBT and GET and their advisors confirm that. They have failed to realise that their advisors are exactly the sort of people who work for drug companies who would normally be debarred from their advisory committees. I genuinely think that it has not occurred to them that this is the case. People are dumb and being dumb is not the same as being unethical. Higher up there are unethical forces at work but attacking people at NICE for being pawns in a game seems to me unlikely to help.

Countering politics with politics may sound all very well but is it. Surely the best thing to do would be to counter politics with science - which is I think what you are suggesting with CPET and would work wonders if F and M show a positive result from phase III rituximab.

And of course CPET is established as a measure of fitness. But what has that to do with ME? The suggestion that there is an additional signature on 2 day CPET for ME is controversial. Betsy Keller in fact found two different patterns and we have not heard much more since. And it is irrelevant to whether or not there is evidence for CBT and GET giving benefit. It is perfectly plausible that even if there was a 2 day signature it indicated something that responded with time to GET.

NICE are a group of stooges who are constantly bombarded by companies about their decisions on spurious grounds as well as valid grounds. They have to sift out the valid ones. I think it may be counterproductive to make that task difficult for them.