Caroline Struthers' letter to Cochrane Governing Board

We/you are assuming they have the same ideological basis as us/you. They don't believe that there is an underlying objective disease, they believe that subjective perception of pain/fatigue/whatever is the illness and that subjective reporting of improvements necessarily represents improvement in the illness, rather than reporting biases.

edit- I just noticed that @Barry made more or less the same point a few days ago...

 

I'm pretty sure a skilled motivational speaker could put a room of people into the state of mind of feeling like a billionaire. Does that mean that these people will leave the room richer?

 

But, as @Jonathan Edwards pointed out in his submission to the Scottish Parliament, the value of PACE is that it provides evidence that the BPS theory is wrong:

 

And indeed indeterminate biases.

 

People generally leave rooms of successful motivational speakers somewhat poorer.

 

Those beliefs are not really ideologically based. They are based in naive incompetence. As we have discussed before there is a contradiction in the premises. If subjective reports at the beginning do not actually reflect the persons activity potential then there is no reason to think they do at the end.

The issue is about the real life intrusion of human nature into clinical trials - which long ago was realised to be such that blinding is needed unless you have cast iron objective end points.

In other words the is no defence for Tovey in the fact that these people cannot even get their ideas coherent!

 

Which is even a problem they noted themselves in the few trials that had both subjective and objective endpoints. They can't explain why patients self-report less fatigue but cannot do more because the truth is devastating to their case and so they just bury it, pretend it's an anomaly when in fact it is falsification.

It is often reported that fatigue is improved in their trials. It is not, it is merely the self-reporting of the perception following conversion therapy aimed at convincing the participants to believe themselves as not as sick as they are, further made irrelevant by reducing a complex illness down to a single hard-to-gauge symptom that is extremely common and whose meaning varies wildly from person to person.

A relevant comparison would be a trial for treatment to reduce excessive hunger where participants rate their hunger as less important but they objectively eat just as much. It's pure junk.

 

This paper argues that there is a sort of hierarchy of subjectiveness of questionnaires with fatigue questionnaires being more subjective than physical functioning questionnaires which tend to mention specific activities.

 

Also shows that the very word "fatigue' is the most inappropriate description for the illness, and also no doubt why it is the most preferred naming by the BPS people.

 

But the speaker leaves considerably richer, and will assume that everyone else does too.

 

I can't remember who said it, but it makes a very important point. The PACE authors insist that changes to the recovery criteria were OK because they were made before they saw any data. However, if you are measuring the height of boys in a school redefining tall as 5ft 8ins instead of 6ft you do not have to have seen any of the results to know that there will now be more boys in the category.

Similarly, if you make the recovery point lower on the scale more people will reach it. If most people will already recovered, you make a good result even better or, as happened, you make a successful trial from a failure.

As is usual with this group they say things that sound impressive but are meaningless.

 

I don't think that they have clearly said this - although they've implied it.

This is what they said in their recovery paper:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776285/

'Before the analysis' is different to 'before data was unblinded'.

In 2011(after the Lancet paper) patient charities made an FOI request for the results of outcomes specified in the trial protocol: https://www.meassociation.org.uk/2011/05/6171/

For the results for the recovery criteria, QMUL stated that these were "exempt under section 22 of the FOIA 2000 on the basis that the authors intend to publish these in the future."

https://www.meassociation.org.uk/wp-content/uploads/2011/06/FOI+from+Queen+Mary.pdf

If that were true, it would mean that the decision to not publish these results came after they had released their Lancet paper. There is no mention of approval for the recovery criteria they used in the 2013 'recovery' paper in the trial's TSC or TMG minutes.

 

Quite. And given the trial had no blinding whatsoever, the researchers will have had strong indications how things were panning out quite early on. I mean, how likely is it really that they were not discussing along the way how things were going - their teams were collecting the data and were fully aware of how that information would have been trending. The data was unblinded before it even went into the database, it was already in the researchers' heads. I cannot believe they did not have good insights into how it might have been unravelling for them, and what would likely 'fix' their problem.

 

I just thought I'd see how the protocol changes were described on the PACE FAQ: (there now seems to only be an annoying link for this: https://www.qmul.ac.uk/wolfson/research-projects/current-projects/projects/#faq )

For their primary outcomes they say the change was : "before any data was analysed".

For the recovery outcome they say the change was: "before the analysis".

I think that this is another example of White trying to be clever with his language.

Fuller quotes:

 

The normal range analysis, which ended up being part of the revised recovery criteria, was described as post hoc in the 2011 Lancet paper.

 

Note that the recovery criteria are not part of the Larun et al Cochrane GET review.

 

That's true, but these protocol deviations are still relevent to the Cochrane assessment of risk of bias, as Courtney pointed out:

https://www.cochranelibrary.com/cds....pub7/detailed-comment/en?messageId=160462675

 

I have vague memories of Wesseley saying something incriminating, probably in one of his "Standing up for science/poor little me, all those militant Me activists are out to get me" speeches. He was referring to saying something like "well we had to change the criteria otherwise no-one would have got better" and then referred to this with a mixed metaphor: something like "I seem to have let the hare out of the bag...."

Does any of this resonate with anyone or am I just having weird dreams. I think @Nathalie Wright might have been at the relevant talk.

 

Wessely:
In essence though they decided they were using a overly harsh set of criteria that didn’t match what most people would consider recovery and were incongruent with previous work so they changed their minds – before a single piece of data had been looked at of course. Nothing at all wrong in that- happens in vast numbers of trials. The problem arises, as studies have shown, when these chnaged are not properly reported. PACE reported them properly. And indeed I happen to think the changes were right – the criteria they settled on gave results much more congruent with previous studies and indeed routine outcome measure studies of which there are many.

https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/comment-page-6/#comments