Independent advisory group for the full update of the Cochrane review on exercise therapy and ME/CFS (2020), led by Hilda Bastian

[Jonathan Edwards]

But it was precisely the problem of the choice of direction that treatment took by the psychiatrists that we are still dealing with. If the psychiatrists had decided that the best treatment for pwME was pacing and rest, then they could have set up clinics to teach patients pacing, and CBT based on a model of overcoming the patients' false beliefs that exercise would cure them.

But that would never have happened because the idea of getting people to exercise to get them out of fatigue goes back much further - certainly to the Second World War and maybe the first. Richard Edwards was recommending exercise in the 1980s. I am not sure that GET was ever really much to do with psychiatrists. Somebody said that some of the psychiatrists were a bit miffed that GET was as good as CBT in PACE.

 

[Jonathan Edwards]

I don't think it has to be just one or the other. Or even just both. The idea of ME/CFS as a psychosomatic illness worked well for quite a lot of groups with power. Plenty of blame to go around.

I agree but I think it is important at this point to re-focus on the blockage with dealing with the Cochrane review. I don't think it is pressure from psychiatry or BPS in general. The people who don't want to see this review give a null recommendation are people like Glasziou, Guyatt, Gotzsche, Garner, Busse, Sterne, Turner-Stokes in rehab and all the physios who are now part of the woodwork in the pain and musculoskeletal group. As Hilda has said the problem is the people who cannot believe that exercise isn't good for everyone. The people who have actually said that out loud are people like Gerada, Glasziou and Gotzsche, not psychiatrists.

 

[Adrian]

Why go on presenting it as a matter of two differing opinions and the need to reach a compromise

Maybe we should also have compromises on other (former) controvertial scientific debates such as whether the earth goes round the sun of the otherway around.

 

[Arnie Pye]

Why go on presenting it as a matter of two differing opinions and the need to reach a compromise.

Maybe we should also have compromises on other (former) controvertial scientific debates such as whether the earth goes round the sun of the otherway around.

Or perhaps we could discuss whether or not doctors need to disinfect their hands after cutting up dead bodies, but before attending pregnant women.

 

[Peter]

The doctrine that “exercise is good for you no matter what and always with no exceptions or nuances”, is a major obstacle. Ideally I would wipe “exercise” out of the vocabulary regarding ME.

This exercise-dogma need modifications, we need understanding that exercise in the real sense and everyday meaning of the word, very often can cause harm to ME-patients, short-term, not at least it could ruin the possibility of a better prognosis completely.

Exercise should be replaced by another term, don’t know which term that would be appropriate. But something like “patients may try to move well inside their limits”. I don’t have a clue, but exercise is just wrong.

Surely many people setting the dogma as advice and priority number one, won’t agree to this, but patients (also ME-patients!) usually know they’re body quite well. Many have been really fit prior to disease, they would do absolutely everything, and in many cases have tried to upheld some kind of exercise/movement. Because they love it and they know the benefits. But the same people have often experienced that it is not healthy, causes PEM, major setbacks and deterioration. And let’s just say that the negative effect is not just a little, a feeling or whatever, but very distinct. This is what these people need to understand, but that would require some trust in ME-patients being able to give insight in their own situation. But why listen to patients that was very fit, have tried exercise in some form a bunch of times, but doesn’t get any better but the opposite?

 

[Art Vandelay]

The doctrine that “exercise is good for you no matter what and always with no exceptions or nuances”, is a major obstacle. Ideally I would wipe “exercise” out of the vocabulary regarding ME.

Exercise should be replaced by another term, don’t know which term that would be appropriate. But something like “patients may try to move well inside their limits”. I don’t have a clue, but exercise is just wrong.

What about "activity"?

I can go into PEM merely from typing or a short email or walking to the kitchen (on a bad day). I doubt either of these qualifies as 'exercise'.

 

[Peter]

What about "activity"?

I can go into PEM merely from typing or a short email or walking to the kitchen (on a bad day). I doubt either of these qualifies as 'exercise'.

Yes, understand. Good points, and this is just ridiculously difficult to get right. Hard to tell if there is 5 or 50 Grand Canyons between the ones talking about exercise for ME-patients and the reality.

 

[chrisb]

it is interesting to reflect that exactly this conversation was carried out in 1989 or 1990 in response to Caroline Richmond's article in a GP magazine in advance of the 1989 paper by SW. The editor provided a helpful picture of a runner. In response to criticism, as I recall it, SW responded that he had been misunderstood and that what was intended was a very gradual increase in daily living activity. He made it sound quite reasonable. Just when this was forgotten is hard to tell.

Exercise is an unfortunately, or conveniently, depending on your point of view, fluid term.

Copies of the article and correspondence are in some thread or other. It might be the RFH Twitter thread.

 

[Snowdrop]

I only have two vague memories on events that have lead to exercise as the cure for all.

On this side of the pond the first is the Kellog's cornflakes guy around the beginning of the 20th C. He was a zealot of a then nonexistent wellness industry and considered cornflakes to be a health food.

Many decades later in Toronto a job I had brought me in contact with the newly minted CEO of a newly minted quasi-government org that was christened with the name Participaction. That was in the early 1980's. Before then nobody gave a rat's behind if you went out for a jog. As participaction got up and running no stone was left unturned finding that last person who was still sitting on their couch eating a snack and watching tv.

So here we are now. The status quo is now saturated with the idea generally.

 

[chrisb]

Many decades later in Toronto a job I had brought me in contact with the newly minted CEO of a newly minted quasi-government org

Ah, well. Toronto, you see.

 

[Snowdrop]

Ah, well. Toronto, you see.

I don't understand the reference. It was a Canadian initiative. I just happen to be from Toronto.

 

[chrisb]

I don't understand the reference. It was a Canadian initiative. I just happen to be from Toronto.

Sorry to be obtuse. I was thinking it was an Ontario initiative rather than national. I have ben looking at papers from th early 1980's suggesting importance of demedicalisation of "illness" issues by such means as exercise and education. The probable driver for this was cost. There seem to have been close links between Toronto and McMaster and the Social Medicine Department at Harvard.

 

[Hoopoe]

There seem to have been close links between Toronto and McMaster and the Social Medicine Department at Harvard.

The psychiatrist who recently claimed long covid is mass hysteria trained at McMaster university.

 

[Invisible Woman]

The psychiatrist who recently claimed long covid is mass hysteria trained at McMaster university.

Should be made go work in A&E and a critical care ward for a week or two. If they had genuine interest in it surely it would be an excellent opportunity to see all that hysteria close up and explain to the patients they just needed to believe they can breathe?

 

[Caroline Struthers]

I am going to this Zoom meeting tomorrow. "Fraudulent trials in systematic reviews – a major public health problem. ". https://lshtm.zoom.us/meeting/register/tJMkdO6pqTooEtT7rIDl4eGuNcjlrZqZ1cnp

I submitted a question which the organiser said she would try to ask the panel at the end. The question is this

Many reviews on the Cochrane Library pre-date the risk of bias assessment and GRADE and will never be updated. Therefore the findings could be misleading and cause harm to patients. Do the speakers think they should be withdrawn?

 

[chrisb]

The psychiatrist who recently claimed long covid is mass hysteria trained at McMaster university.

Yes. The work of Arthur Cott and his department seems worthy of closer scrutiny. And will receive it when I feel up to it.

 

[Caroline Struthers]

I am going to this Zoom meeting tomorrow. "Fraudulent trials in systematic reviews – a major public health problem. ". https://lshtm.zoom.us/meeting/register/tJMkdO6pqTooEtT7rIDl4eGuNcjlrZqZ1cnp

I submitted a question which the organiser said she would try to ask the panel at the end. The question is this

Many reviews on the Cochrane Library pre-date the risk of bias assessment and GRADE and will never be updated. Therefore the findings could be misleading and cause harm to patients. Do the speakers think they should be withdrawn?

My question was not asked. It wasn't really relevant to the general discussion which focused on fraud rather than out of date misleading cochrane reviews and dodgy psychological trials, so I am not surprised.

 

[petrichor]

So, I'm not an expert on this, so hopefully someone can help me with this. The general idea of systematic reviews, like what cochrane does, is that the evidence is reviewed using explicit, systematic methods that minimise bias in the reviewing process. So that someone could follow the same processes, and have the same findings (it's replicable).

One of the key criticisms of the PACE trial and other GET trials was that they were unblinded, and subjective questionnaire outcomes were used (1). This is especially exacerbated in the light of how participants were told things like to ignore or dismiss their symptoms, and change their "illness beliefs", which could mean people could score better on subjective questionaires for reasons other than a real improvement (2). So the question is whether 1 and 2 could be taken account of properly in a systematic review.

1 could probably be taken account of in a systematic, replicable way. Identifying whether trials use subjective questionnaire outcomes and whether they're unblinded is a relatively objective fact, although not necessarily that simple. However wholely dismissing the results of unblinded trials that rely on a subjective questionnaire outcome is a pretty radical step, and for consistency that should also mean all other such trials in other systematic reviews should also be dismissed. Maybe that would be justified, but I can't see such a radical stance being taken. 2 is substantially harder to take account of in a systematic and replicable manner. Whether treatments in trials entail what could possibly be called a "treatment-inherent cognitive bias" (a term discussed in another thread) is a debatable fact, and involves poorly measurable details about how the treatment works, and such details may not even be recorded and could be easily misrepresented.

So if 1 isn't taken account of properly, because that would be too radical and inconsistent with other systematic reviews, and 2 isn't taken account of because it simply isn't possible to do in a systematic replicable manner, does this significantly limit a cochrane review of GET? And what possible ways are there to take account of those two problems, whilst still being consistent with the limitations of a systematic review?

 

[Hutan]

However wholely dismissing the results of unblinded trials that rely on a subjective questionnaire outcome is a pretty radical step, and for consistency that should also mean all other such trials in other systematic reviews should also be dismissed. Maybe that would be justified, but I can't see such a radical stance being taken.
...

...
And what possible ways are there to take account of those two problems, whilst still being consistent with the limitations of a systematic review?

I guess I'd question your fundamental premise. Would a pharmacological treatment be accepted if all the trials showing its efficacy were unblinded and the important outcomes were only subjective? I don't think so. So, why would that be acceptable with other sorts of treatments? Requiring good science doesn't seem like a radical stance. Are you suggesting that we should find a way for the GET trials to be dismissed that will leave the findings of other reviews with the unblinded trial/subjective outcomes problem unaffected - reviews that probably also have seriously negative consequences for people?

Yes, the specifics of a disease can make things complicated; just requiring that there be an objective outcome isn't enough. I've mentioned before that scientists and advocacy groups working on particular illnesses might choose to get together and make an explicit list of outcomes that any treatment study should include. For example, for anorexia nervosa, the objective outcome of weight is not sufficient in determining treatment success if only measured immediately after treatment - anorexia nervosa researchers have called for outcome standards for research that include longer term followup. For ME/CFS, an objective outcome of activity monitored for only a week after a treatment ended would be hopelessly inadequate.

In the absence of an agreed illness-specific standard for core outcomes, Cochrane needs to clearly state what outcomes its reviewers have judged as indicative of treatment trials meeting basic reliability standards. If Cochrane sincerely thinks that unblinded trials with subjective outcomes assessed soon after the treatment ends are totally fine when assessing treatment trials for a particular illness, then it needs to state that upfront in its reviews. And then everyone can draw their own conclusions about the quality of the review and the reviewers, and the utility of the Cochrane brand.

 

[petrichor]

I guess I'd question your fundamental premise. Would a pharmacological treatment be accepted if all the trials showing its efficacy were unblinded and the important outcomes were only subjective? I don't think so. So, why would that be acceptable with other sorts of treatments? Requiring good science doesn't seem like a radical stance. Are you suggesting that we should find a way for the GET trials to be dismissed that will leave the findings of other reviews with the unblinded trial/subjective outcomes problem unaffected - reviews that probably also have seriously negative consequences for people?

Yes, the specifics of a disease can make things complicated; just requiring that there be an objective outcome isn't enough. I've mentioned before that scientists and advocacy groups working on particular illnesses might choose to get together and make an explicit list of outcomes that any treatment study should include. For example, for anorexia nervosa, the objective outcome of weight is not sufficient in determining treatment success if only measured immediately after treatment - anorexia nervosa researchers have called for outcome standards for research that include longer term followup. For ME/CFS, an objective outcome of activity monitored for only a week after a treatment ended would be hopelessly inadequate.

In the absence of an agreed illness-specific standard for core outcomes, Cochrane needs to clearly state what outcomes its reviewers have judged as indicative of treatment trials meeting basic standards. If Cochrane sincerely thinks that unblinded trials with subjective outcomes are totally fine when assessing trials for a particular illness, then it needs to state that upfront in its reviews. And then everyone can draw their own conclusions about the quality of the review and the reviewers, and the utility of the Cochrane brand.

As far as I can tell the current standard is that subjective outcomes in unblinded trials are basically accepted, although they get marked down a bit or a moderate amount to take account of possible bias, and if the patient reported outcome measures aren't good quality either (like the chalder fatigue questionnaire), then that doesn't help either. I'm not trying to open the whole subject of trying to make cochrane disregard unblinded trials that rely on subjective outcomes. The question I'm trying to ask, is that given they don't seem likely to do that, what ways are there to take account of those two key problems (unblinded with subjective outcomes + treatment-inherent cognitive bias) with the PACE trial while still being consistent with the limitations of how systematic reviews are done?