Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome, 2021, White & Etherington

Adrian said:
Also (and perhaps this is as I've only looked at the abstract) they don't seem to define a time scale over which the meaurements are taken.
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Skimming the paper assessment times were anything from 12 weeks to 18 months! Doesn't than make a comparison dodgy?

ALso very different treatments they talk about a couple of trials with higher intensity exercise and say something about differences in the result here:

When examining this latter result in more detail,relatively large proportions dropping out of trial follow up, after receipt of GET, occurred in two trials that started GET at a relatively high intensity (70% estimated VO2 max or 70% of heart rate at individual anaerobic threshold), where 18% and 27% dropped out after GET compared to 10% and 15% after control interventions [7, 14]. The third trial with a relatively high proportion of trial drop-outs occurred after anaerobic GET (28% versus 19%)[
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Is this saying if you actually get people to do get then the results are worse in terms of drop outs. What may be a key metric is the 'dose' of GET vs the damage/drop out rate.

With the dropout rate we also don't know the treatment profile for example if people stopped doing GET but filled out forms that isn't known or reported. To my mind as structural uncertainties are introduced into measurements then this should be in someway represented in the uncertainty of the results.
 
Furthermore, the PACE trial showed that PEM was most likely to improve after GET, compared to comparison treatments of adaptive pacing therapy and specialist medical care [4].
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This feels like a strange claim to me - it is a long time since I read to lancet article but I don't remember them making any measurements of PEM that would allow them to make any such claims. I suspect it is some weird interpretation of the outcome data with people who fitted their version of the london criteria but it just feels like a really misleading claim.
 
.4. What if GET was banned?

If GET were banned, patients and healthcare professionals would be unable to access/provide one of only two evidence-basedtreatmentsavailable for CFS [5]. Researchers would be unable to obtain ethicalapprovals for future trials of a banned treatment. Are there any other negative consequences that might follow?
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Another weird paragraph from the discussion and following stuff from NICE - NICE do not ban treatments the make recommendations of things that have efficacy at a reasonable cost. So they are really trying to overstate things with their friends.

Clearly this is more of a lobbying paper than a peice of academic work.
 
We have to remember that the evidence threshold needing to be crossed for demonstrating something to be safe is not the same threshold needing to be crossed for demonstrating it to be unsafe, not should it be. Otherwise the evidence level could be just on the unsafe side, and the tiniest change in evidence level make things appear safe again. (It is why the on and off thresholds for your boiler thermostat are different, else there would be times the boiler would be rapidly thrashing on and off simply due to minor random variations of the temperature signal).

So, same as with safety engineering such as in aerospace, automotive, etc. (I cannot imagine why psychiatric medicine has not learned these fundamental safety lessons), the evidence threshold for acknowledging the potential for harms is set inevitably at a significantly less stringent level than the evidence threshold needed for demonstrating something to be safe.

So in the Boeing 737 Max saga, it would have been outrageous to demand the same very high evidence level be crossed to prove the system to be harmful, as subsequently required to prove it to be safe; far more people would have had to die before that level of evidence of harms were attained.

So the evidence sources used for demonstrating likelihood of harms will typically and validly include sources that may be deemed inadequate for demonstrating evidence of safe usage. Anecdotal evidence could be one such example. Anecdotal evidence alone, no matter how compelling, is not going to reach the evidence level needed to prove something is safe, with adequate statistical probability. But compelling anecdotal evidence showing potential for harms might easily and validly reach the evidence threshold needed for evidence of potential harms.

Anecdotal evidence of potential for harms is not to be dismissed therefore simply because it is anecdotal, even though the same argument is much more valid for evidence of safety.
 
Adrian said:
Clearly this is more of a lobbying paper than a peice of academic work.
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Absolutely. Which is where my worries from a couple of months back came from - these folk are past masters at influencing outcomes ( :p:rolleyes::oops: ), and it would be appalling if they did somehow manage to influence the NICE guideline outcome with all this eminence-driven whining of theirs.
 
empowering the individual to take control of their own exercise plan and recovery.
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Why do we need an exercise plan? This shows the embedded implicit idea that we are ill because we don't exercise instead of the basic fact we cannot exercise because we are ill. Ramsay said that getting better by exercising is a way of distinguishing those who do not have ME since ME is defined as getting worse with exercise.

This basic misunderstanding of the essence of ME has caused all the weirdness and controversy we have faced for over forty years.

To me, the fact that the BPS clique work to improve their own standing and not for the wellbeing of their patients is most obvious in the way they deal with harms.

When a doctor is told that his treatment is causing patients to become wheelchair and bed bound the only acceptable answer is to do an intense, detailed study to examine the possibility using the most stringent criteria to pick up the slightest of harms.

The way that they try to show there is no harms by using abysmal scales, shoddy methodology, the trick of not investigating drop outs all show the sort of people they are. Denigrating patient surveys and patient experience is not acceptable in any way. Treatments must be shown to be safe, that is the first rule of medicine.

The suggestion that one child has been crippled by a treatment should have set alarm bells off the length of Britain.

Imagine a pharmaceutical company doing the same thing.
 
Adrian said:
This feels like a strange claim to me - it is a long time since I read to lancet article but I don't remember them making any measurements of PEM that would allow them to make any such claims. I suspect it is some weird interpretation of the outcome data with people who fitted their version of the london criteria but it just feels like a really misleading claim.
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IIRC, they measured PEM with a single self-report question.
 
Adrian said:
This feels like a strange claim to me - it is a long time since I read to lancet article but I don't remember them making any measurements of PEM that would allow them to make any such claims. I suspect it is some weird interpretation of the outcome data with people who fitted their version of the london criteria but it just feels like a really misleading claim.
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They never, at any point, mentioned or gave consideration to PEM in their decades-long careers, not once other than in dismissing it as something patients report but is not possible given the lack of an established pathology. Always framed psychologically or as "post-exercise fatigue", which is a completely different thing.

That they can actually pretend they did when they clearly did not and this "passes" peer review is an absurd failure on the part of the journal and the entire ideology of psychosomatic medicine. But then again it's basically their own journal with their buddy as VP so whatever, just normal corruption in EBM.
 
The 2011 Lancet paper, ref 12 refers to ...

https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-3-25

... when speaking of PEM definition. In that paper there are 3 mentions of PEM, the most expansive one being:
However, CFS patients have an exaggerated fatigue response to previously well-tolerated activities and many report their fatigue is unusually sensitive to physical or mental exertion. Indeed, post-exertional malaise lasting more than 24 hours is one of the accompanying symptoms that define CFS. Therefore, this requirement should be interpreted as referring to exhaustion unrelated to an excessively demanding schedule that would induce fatigue in an otherwise healthy adult.
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To be fair this paper is 1994, but it clearly:
  • Presumes PEM to be primarily symptoms of fatigue, and
  • Of at least 24 hours duration.
As we all know, PEM encompasses far more than fatigue, and it is strange it is referred to as malaise but identified in terms of fatigue.

I know that many pwME experience PEM for long durations, but I do not think that is always the case. My wife, who I would think counts as mild these days, can feel totally crap for some time, but not all those times will be as long as 24 hours. An arbitrary cut off time like that could well distort any measure of improvement. e.g. More frequent PEM but of shorter durations might get measured as no PEM for example. What is needed is the DATA!
 
In general it takes me 2-3 days to recover. It also depends on how much I've overdone. Many years ago I decided to go for a light jog (25 minutes) because I was feeling particularly good for 2 days, it took one week to recover. It was horrible.

I don't consider myself mild, moderate or severe. I've felt 90% improved for a few years and PEM was just as horrible. How much I go over my 'energy window' determines my PEM duration.
 
Barry said:
More frequent PEM but of shorter durations might get measured as no PEM for example. What is needed is the DATA!
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Yep and a mildly affected patient who is constantly in PEM may not realise it because they don't know really any better.

I reckon I spent a lot of time as a moderately ill patient in constant PEM in the early days of illness. I just thought that was the illness.
 
However, CFS patients have an exaggerated fatigue response to previously well-tolerated activities and many report their fatigue is unusually sensitive to physical or mental exertion. Indeed, post-exertional malaise lasting more than 24 hours is one of the accompanying symptoms that define CFS.
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The problem I have with that it sounds like a failure to distinguish between feeling tired after exercise and PEM. In my experience these are two different phenomena and feeling tired after exercise is much less a problem than PEM.
 
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