Brain Retraining treatment for ME/CFS and Long COVID - discussion thread

@Yann04 I have read the thread on the book now, and it seems like the review is slightly inaccurate. So apologies for that.

An important point is that the review claims that all of the issues with the PACE trial exaggerated the effect of GET. They did not. They created the illusion of an effect that did not exist in the first place. Nothing was exaggerated.
 
Trish said:
It would be helpful for us to understand your perspective in this discussion if you tell us whether you are writing from the perspect of a clinician listening to their patients, or a pwME reading patients stories on social media. I'm not asking you to tell us your name, that's up to you, but I'd like to know whether I'm trying to help a clinician understand better what may help or harm their patients, or a pwME to understand the basis of claims by their clinician to help them decide what treatment to try, a recovered pwME keen to share what they think helped them, or someone else who just enjoys provoking an argument.
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My goal is to help patients.
Evergreen said:
You're right, it is important to be accurate in claims. What you say is correct, but what people on here care about is whether the statistically significant difference between groups that existed at 52 weeks was maintained at long-term follow-up, and it was not. So what @Trish said was correct. The statistical significance that did exist did not persist.

What researchers have tended to do when the between-groups differences don't work out is focus on the within-groups differences, which are meaningless in terms of efficacy. They're only reassuring in terms of demonstrating that people did not report that GET/CBT made them worse on subjective outcome measures. Which unfortunately is not particularly reassuring, because people's self-reports are so vulnerable to being swayed, as Wechsler et al. 2011 shows. Wechsler et al. 2011 is mentioned above and is being discussed in this thread:

https://www.s4me.info/threads/activ...rvention-in-asthma-2011-wechsler-et-al.43655/

And what Wechsler et al. 2011 demonstrates so clearly is that the statistically significant differences in subjective outcomes that, if I've understood correctly, you see as evidence of some people improving from GET and CBT, tell us nothing about whether or not GET or CBT are effective for anyone with ME/CFS. But the lack of significant differences between groups in most objective measures do tell us that they're ineffective.

That's why Trish said "short term significance in subjective questionnaires".

Edit: Made a few edits for clarity.
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What the PACE trial and the FITNET trial showed in long-term follow-up was that usual care eventually caught up with the treatment group, but much more slowly.

I agree that subjective outcomes are not ideal and introduce bias. The Wechsler trial is interesting, and does show that subjective outcomes are not useful in assessing asthma. However, are they useful in assessing a subjective outcome, such as depression from asthma? As for ME/CFS, we don't have any objective measures. What might be useful would be to measure activity for severe patients in a rehab trial, with a long-term follow-up. That is the only objective measure I can think of.
 
dundrum said:
I agree that subjective outcomes are not ideal and introduce bias.
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In an open-label trial, why do you think that subjective outcomes are merely 'not ideal' rather than fatal?

You seem to be putting some sort of limit on the bias that they can introduce. Do you think that bias can turn a null result into a positive one?

Dundrum said:
As for ME/CFS, we don't have any objective measures. What might be useful would be to measure activity for severe patients in a rehab trial, with a long-term follow-up. That is the only objective measure I can think of.
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Measuring activity for PwME was already thought of in the PACE trial, who used actimeters at the start of the trial and then went against their own study protocol and binned them. They would have provided an objective measure.
 
dundrum said:
The Wechsler trial is interesting, and does show that subjective outcomes are not useful in assessing asthma.
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That is not the only thing it shows. It proves that subjective outcomes can create an illusion of an effect with the same size as the effect of an actual treatment.

This means that we can’t categorically exclude the possibility that any other subjective outcomes can create a similar illusion, fully or partially.

Which in turn means that any subjective outcomes has to be considered to be inherently unreliable to at least some extent.
dundrum said:
However, are they useful in assessing a subjective outcome, such as depression from asthma?
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The fact that the thing you’re trying to measure is subjective by nature, doesn’t change the inherent unreliability of the subjective outcome measures. It has to be accounted for, even if it’s the best you’ve got. And there is no law that says that your best is good enough for science. So we have to entertain the possibility that it might not be good enough, period.
dundrum said:
As for ME/CFS, we don't have any objective measures. What might be useful would be to measure activity for severe patients in a rehab trial, with a long-term follow-up.
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I know we are speaking of hypotheticals here, but I want to emphasise that the first thing you should consider when designing an intervention trial is the risk of the intervention.

A rehab* trial for severe ME/CFS patients will never be ethical to conduct due to the risks involved. Unless, of course, the researchers are convinced that the intervention can’t possibly be harmful to severe patients under any circumstances. But that would make them entirely unsuited to conduct such a trial in the first place.
Edit: *based on the current prevalent rehab methodology.
 
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dundrum said:
What might be useful would be to measure activity for severe patients in a rehab trial, with a long-term follow-up. That is the only objective measure I can think of.
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Off the top of my head:
  • Step counters.
  • Gyroscopic sensors to measure the orientation of the upper body and legs to try to assess orthostatic intolerance.
  • Medication usage for symptom relief.
  • Wages/Hours worked.
  • Sleep measurements.
  • Weekly time spent by carers.
  • Tracking if specific ADL’s are performed or not.

None of these are perfect. But with rigorous methodology and neutral interpretations they might be able to tell us something?
 
dundrum said:
What the PACE trial and the FITNET trial showed in long-term follow-up was that usual care eventually caught up with the treatment group, but much more slowly.
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That's how the researchers interpret it. But because of the reliance on subjective measures in unblinded trials, and the dismal performance on more objective measures, the most justifiable interpretation is that people in the GET and CBT groups were sufficiently enthused that they temporarily changed how they completed questionnaires.

dundrum said:
I agree that subjective outcomes are not ideal and introduce bias. The Wechsler trial is interesting, and does show that subjective outcomes are not useful in assessing asthma.
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It's not people's asthma that made them respond as they did to the subjective outcome. It's their human psychology.

dundrum said:
However, are they useful in assessing a subjective outcome, such as depression from asthma?
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I'll let someone like @hibiscuswahine or @SNT Gatchaman answer regarding depression. But regarding whether subjective outcome measures are useful in assessing subjective symptoms like fatigue? The same human psychology would be at play, so no to exclusively subjective primary outcome measures, but yes to primary measures comprising both subjective measures and more objective measures.

dundrum said:
As for ME/CFS, we don't have any objective measures. What might be useful would be to measure activity for severe patients in a rehab trial, with a long-term follow-up. That is the only objective measure I can think of.
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Well, I wouldn't suggest severe patients go near a rehab trial until we have
(a) rehab being trialled that is significantly different from what has gone before,
(b) evidence from trials with multiple objective primary outcome measures that mild and moderate patients benefit (between-group differences, not within-group differences), and
(c) evidence that benefit lasts.
We do not have any of those. For those with mild and moderate ME/CFS, there are lots of other more objective measures like hours in work/education, or various tests physios use like how many sit-to-stands you can do in 30 seconds, but none as good as the forced expiratory volume test in asthma, because we don't understand the pathophysiology yet.
 
dundrum said:
What might be useful would be to measure activity for severe patients in a rehab trial
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we had a rehab trial for severe patients, or at least homebound ones, called FINE. The PACE team kept touting it as their "sister trial"--but the PACE papers didn't mention it. It published null results for its subjective outcomes in 2010, a year before PACE--so PACE disappeared it, even though it had been billed as PACE's "sister trial." If that does not represent bad faith and constitute a form of research misconduct, I'm not sure what does.
 
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Utsikt said:
Said by the bastards that don’t want to do better
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The lead investigator of FINE was telling people that ME or CFS was like really bad jet lag. Since that's how those providing the care were essentially indoctrinated, I have some sympathy for some of their frustration at not seeing people improve. It doesn't justify hostility, obviously, but it's understandable to me. In other words, the nurses and others might have wanted to do better but were really being misled by the investigators.
 
Jonathan Edwards said:
And shed a little light on how health professionals really think:
"The bastards don't want to get better".
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For anyone who is not familiar, these immortal words were how a supervisor of the nurses who delivered the treatments in the FINE trial characterised the nurses' attitude to the patients at times:
There have been one or two times where I have been worried because they have got angry at the patients...that anger has been communicated to the patients. Their frustration has reached the point where they sort of boiled over... there is sort of feeling that the patient should be grateful and follow your advice, and in actual fact, what happens is the patient is quite resistant and there is this thing like you know, “The bastards don’t want to get better”...I think it’s a difficult thing for all therapists and I think basically over the time you just basically learn to cope with it, and but they have not had time.’ (Supervisor)
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It appears in this paper:
https://pmc.ncbi.nlm.nih.gov/articles/PMC3259041/
Peters S, Wearden A, Morriss R, Dowrick CF, Lovell K, Brooks J, Cahill G, Chew-Graham C; FINE Trial Group. Challenges of nurse delivery of psychological interventions for long-term conditions in primary care: a qualitative exploration of the case of chronic fatigue syndrome/myalgic encephalitis. Implement Sci. 2011 Dec 22;6:132. doi: 10.1186/1748-5908-6-132. PMID: 22192566; PMCID: PMC3259041.

The FINE trial itself is here:
https://pmc.ncbi.nlm.nih.gov/articles/PMC2859122/
Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group. Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial. BMJ. 2010 Apr 23;340:c1777. doi: 10.1136/bmj.c1777. PMID: 20418251; PMCID: PMC2859122.
 
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dave30th said:
The lead investigator of FINE was telling people that ME or CFS was like really bad jet lag. Since that's how those providing the care were essentially indoctrinated, I have some sympathy for some of their frustration at not seeing people improve.
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I disagree on the sympathy point, but it’s only a matter of personal opinion.

There is no sympathy to be had for claiming that the patients did not want to improve. If they said ‘the bastards don’t improve’, I might have had some sympathy with them because it’s tough to watch suffering and not being able to help.

They should have know better than to listen to the investigator against the evidence to the contrary from their experiences with the patients.

Decent people have been indoctrinated before, and done far worse things. So I understand how it could happen, but they do not get my sympathy.
 
Utsikt said:
I disagree on the sympathy point, but it’s only a matter of personal opinion.
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I expressed sympathy for their frustration, not for their manner of expressing it. But I've certainly said things I wish I could un-say, that I meant in the heat of the moment but didn't mean in the larger sense or upon reflection and after internal debate with the better parts of my nature.
 
dave30th said:
we had a rehab trial for severe patients, or at least homebound ones, called FINE. The PACE team kept touting it as their "sister trial"--but the PACE papers didn't mention it. It published null results for its subjective outcomes in 2010, a year before PACE--so PACE disappeared it, even though it had been billed as PACE's "sister trial." If that does not represent bad faith and constitute a form of research misconduct, I'm not sure what does.
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Yes, good point. It had a statistically significant reduction in fatigue, but not physical function, and it wasn't maintained at follow-up.

I'm not sure how they "disappeared" it, if it was published in the BMJ:

https://www.bmj.com/content/bmj/340/bmj.c1777.full.pdf

It seems ridiculous to call that "research misconduct", when they published the results.
 
Evergreen said:
Well, I wouldn't suggest severe patients go near a rehab trial until we have
(a) rehab being trialled that is significantly different from what has gone before,
(b) evidence from trials with multiple objective primary outcome measures that mild and moderate patients benefit (between-group differences, not within-group differences), and
(c) evidence that benefit lasts.
We do not have any of those. For those with mild and moderate ME/CFS, there are lots of other more objective measures like hours in work/education, or various tests physios use like how many sit-to-stands you can do in 30 seconds, but none as good as the forced expiratory volume test in asthma, because we don't understand the pathophysiology yet.
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Well the problem we have is [1] patients are dying from malnutrition and [2] patients are recovering from doing things like "brain retraining". So I don't think it's good to just do nothing. There are many aspects of these therapies that aren't problematic, and which seem to help patients. So what is wrong with either testing those, or offering patients advice? Surely death or permanent disability isn't the desired outcome here. Giving up and doing nothing until someone finds a biomarker or similar doesn't seem useful either. If it is a functional issue in the brain, it's likely going to take another few decades to show that definitively.
 
dundrum said:
It had a statistically significant reduction in fatigue
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I have called it "research misconduct" on the part of the PACE authors for them to completely "disappear" the FINE findings by not mentioning them in their own papers after years of promoting htem a PACE's "sister study." And yes, failing to provide an accurate account of the background in your intro and for assessing your results is a form of research misconduct. In their protocol, they had actually said don't pay attention to transient changes right after therapy. But then in reporting it, they did. They were pretty minimal improvements in any event.
 
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Utsikt said:
Off the top of my head:
  • Step counters.
  • Gyroscopic sensors to measure the orientation of the upper body and legs to try to assess orthostatic intolerance.
  • Medication usage for symptom relief.
  • Wages/Hours worked.
  • Sleep measurements.
  • Weekly time spent by carers.
  • Tracking if specific ADL’s are performed or not.

None of these are perfect. But with rigorous methodology and neutral interpretations they might be able to tell us something?
Click to expand...

The problem is that these aren't really markers for ME/CFS, and in mild patients (who tend to go into these trials), there may be no difference in step counts or wages.
 
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