Caroline Struthers' correspondence and blog on the Cochrane Review: 'Exercise therapy for chronic fatigue syndrome, 2017 and 2019, Larun et al.

Not read the whole thing yet, but this is one of the points she make in the complaint letter:

The recent decision by the Health Research Authority (HRA) to cite the exercise review as evidence that PACE was viewed as a well-conducted trial indicates that this is an urgent matter.

In the letter to Rt. Hon Norman Lamb MP of the Science and Technology Committee, the HRA stated that “The robustness of the PACE trial has been considered in a Cochrane review that classified it as high quality”. The review is therefore continuing to influence health care policy as well as the opinions of politicians and health officials because of the failure of the authors to respond appropriately to concerns about their work, and lack of necessary action by Cochrane.
 
An interesting technical point occurred to me that I thought I would post here, as it is relevant to the quotes about unbounded trials.

PACE was too big. It might seem odd that a trial could be too big but I think it was.

In general, unblinded trails are phase 1 or phase 2 trials designed to get initial indicators of response but not proof of concept. They tend to be small. As a result, any systematic bias due to subjective outcomes has to be large to reach statistical significance.

What is unusual about PACE is that it was very large. Proof of concept phase 3-type studies tend to have about 40 subjects per arm to show a major benefit. Numbers go up to the 160 per arm in PACE only if the power calculation is based on the need to get statistical significance with a rather modest benefit of the test treatment.

The problem is that this means that you will get a 'statistically significant' bogus positive result even with a relatively modest difference due to systematic bias. Large trials are at greater risk of bogus results from systematic bias.
 
The most controversial point in Tovey’s response concerns the issue of “using only subjective outcomes in unblindable trials”. “To describe this as ‘terrible methodology’ is simply an opinion”, Tovey says, “and it is not shared by independent methodologists who we consulted". Weird.

To use the argument it is simply a matter of opinion is appalling.

If Cochrane wants to be taken seriously, they should be standing for the highest levels of scientific methodology.

Caroline’s response to this included the following quotes made by Jonathan Edwards earlier in this thread (with reference to S4ME):

The problem of unblinded trials with subjective end points is not 'just an opinion'. It is the only sensible view and is embedded in all evidence based medicine. With due respect if Tovey's advisors do not share this view they are incompetent. Again with due respect if Tovey is not aware of this he is not qualified to act as an editor in an organisation like Cochrane. He seems to have acted fairly so far but in this instance he appears to be indicating that he has no grasp of reliable evidence. That makes Cochrane something of a basket case maybe.

The problem of subjective end points with no blinding is as basic as it gets. It is the reason we have blinded trials. No trial with this design of a drug would be taken seriously. Moreover the problem is much worse with therapist delivered treatments, not less bad, because of the role playing and manipulation of attitudes that is inherent in the human interaction.

I am afraid this hits rock bottom.

I think an apology is due, together with an admission that the comment about 'just an opinion' was not appropriate. If a Cochrane official makes a statement like this it effectively destroys the Cochrane reputation entirely.

:thumbup:
 
This involved telling patients things such as “every exercise is strengthening your body”, “there is no disease” and “from the moment you walk out of this room your recovery is beginning”.
In the world of commerce this would be a flagrant breach of trade descriptions. They had no evidence for the claims they were 'selling' to people, just there own entrenched beliefs. This feels like it should be a major breach of medical ethics in its own right. Unless it is known for sure these things are true, then making such coercive statements must surely breach some medical ethics code or other? If not then why not?
 
I have read Caroline Struthers detailed letter and am very grateful for the work put into it. It's very thorough and really excellent.

As well as the important points made about the Cochrane Exercise Review, and the request that it be withdrawn immediately on scientific grounds I particularly appreciate the emphasis on ongoing harm to patients from the continued existence of such a flawed review. As a patient I really appreciate that concern for our welfare.

I am heartened that people with professional standing like Caroline, as well as Hilda Bastian, David Tuller, and others are putting their weight behind our battle against the entrenched forces of the BPS cabal.

In a gloomy moment, I wonder whether they will ever be able to be shifted. I have been looking at some of James Coyne's blogs from 2-3 years ago, and he was making some of the same arguments with David Tovey back then, but nothing happened. Kindlon and Courtney gave strong arguments that the Cochrane review should be withdrawn, and the weight of evidence from all the critiques of PACE and Cochrane from Wilshire, Geraghty, Vink and others has mounted steadily. Yet still nothing happens.

With the NICE guideline review under way, it is even more urgent that this Cochrane review be withdrawn.

Does anyone really know why it hasn't been withdrawn? What machinations are going on behind the scenes? And how can they be exposed and stopped?
 
Does anyone really know why it hasn't been withdrawn? What machinations are going on behind the scenes? And how can they be exposed and stopped?

My guess would be that all agencies, publications, reviewers and parties involved are holding out on the basis that, "some other group thinks PACE is great so we will just use that as our get out".

No one wants to take on the basic premise for themselves partly because they may have some responsibility in the whole saga or they have some mates it points fingers at, partly because they know there is pressure from within the cabal on each participant individually.

HRA didn't budge cos Cochrane didnt budge, Cochrane didnt budge because the Lancet didnt budge, Lancet cant budge at all, DWP wont budge cos NICE hasn't budged, NICE tried not to budge cos DWP cant budge. All of the above wont budge cos the PACE PIs say they themselves are wonderful and great.

Everybody is just sitting there saying "well if that other group thinks its ok we can just point a finger at them and say they have passed it". But that other group is just saying the same thing about the first group and the second and so on. Just relinquishing their own responsibility to evaluate the basic premise for themselves.

Its somewhat like crap journalism wherby one media outlet after another reports on each others story without checking the original source first by just saying, "it has been reported that".

It just goes round and round on and on.
 
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It just goes round and round on and on.

My hope is that when one of them falls, the whole circle will just collapse.

Unfortunately the British way is to wait till the principles have died, which people are no longer prepared to tolerate.

At present my money is on Cochrane being the first to go, given good science is their raison d'être, and there must be many involved with the organisation as a whole who, once fully aware of the current mess, will put their own reputation before the old boys' network.

[added - I would love to be a fly on the wall if the Cochrane board actually discusses Caroline Struthers' response.]
 
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I'd wanted to double check some things in this reply, but found that the whole Cochrane website was down.
Apologies if this had been already posted - just saw this when I checked which Cochrane sites were currently availble:
https://www.cochrane.org/news/cochrane-seeks-editor-chief-cochrane-library

"Dr David Tovey, Cochrane’s first Editor in Chief, is stepping down at the end of May after 10 years in the role."
Cochrane seeks Editor in Chief of the Cochrane Library

Salary: £150,000 - £170,000
Location: Flexible
Application Closing Date: 28th February 2019

Dr David Tovey, Cochrane’s first Editor in Chief, is stepping down at the end of May after 10 years in the role.

His successor - as both the external face of Cochrane’s content and the internal lead for the editorial production of Cochrane evidence - will play a key role in taking the organization forward beyond our existing Strategy to 2020.

You can find further information on the role, including details about how to apply and closing date for applications, here.

The new Editor in Chief can be located anywhere in the world although there is a preference for London, UK.

Wednesday, February 13, 2019

Edit: correct URL
 
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Hallelujah!


ETA: post can be located anywhere in the world but London preferred. Maybe better away from London???
ETA2: This is not any comment about Caroline who would be great rather about being further away from the BPSers
 
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I'd wanted to double check some things in this reply, but found that the whole Cochrane website was down.

Maybe the board read this, realised that they were rubbish, and so just pulled the plug? "We're off."

Was it the main Cochrane site (https://www.cochrane.org/) or the Cochrane Library that you had problems with?

I am able to access the main site, but have problems accessing their Library from my iPad. I usually have to try several different browsers till I find one that will let me load it.
 
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