Cochrane Exercise Review Withdrawn - Individual Patient Data

Trish said:
It looks like the objection to the now withdrawn protocol was at least in part because the team doing it included White, Sharpe, Chalder, Weardon etc. ie people whose research was to be reviewed.

It seems that the Norwegian trio, Larun, Brurberg and Kristoffersen are now the author team for the new review and the have started work on it. The date of update is August 2022 and it says it's ongoing.
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=107473&VersionID=1771625
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I am fairly sure the full author team, including White et al submitted a manuscript of the full IPD review. It was then peer reviewed, including by patients (or as Cochrane call them, consumers) and did not past muster, to put it mildly. I'm not 100% sure of this, as it was a while ago, and I may have misremembered. I was told this by a person with ME, but I can't remember if this person had a/ requested to see the draft of the IPD review and was endlessly told "there wasn't time", or b/ actually did see it and had a chance to give feedback. So yes I think the review was pulled partly because of the authorship optics, but also because it was not a good review. Bad enough to pull it altogether rather than allow the authors to endlessly amend it. I would love to get the correspondence actually. I might try and get it via the Norwegian Institute of Public Health (Freedom of Information).
 
Trish said:
It looks like the objection to the now withdrawn protocol was at least in part because the team doing it included White, Sharpe, Chalder, Weardon etc. ie people whose research was to be reviewed.

It seems that the Norwegian trio, Larun, Brurberg and Kristoffersen are now the author team for the new review and the have started work on it. The date of update is August 2022 and it says it's ongoing.
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=107473&VersionID=1771625
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Tweedle Dee can't do that, but Tweedle Dum can.

Very serious organization.
 
So, it's definitely not a Cochrane review? I suspect it will give a fairly good impression of one. The protocol mentions using the Cochrane database and using Cochrane tools.

It's not clear from the protocol what the definition of 'CFS' is. The 'condition' mentions a main symptom of post-exertional malaise. But the presence of PEM doesn't seem to have any bearing on whether a trial is included or not.

Condition or domain being studied
Chronic fatigue syndrome (CFS) is an illness characterised by persistent, medically unexplained fatigue, where the main symptom is post-exertional malaise. Symptoms also include musculoskeletal pain, sleep disturbance, headaches, and impaired concentration and short-term memory. The term 'myalgic encephalomyelitis' (ME) is often used.

Participants/population
We will include male and female participants over the age of 17, irrespective of culture and setting. As several sets of criteria are currently used to diagnose CFS we will include trials given that the patients fulfill the following diagnostic criteria for CFS:

  • Fatigue or a synonym is a prominent symptom;
  • Fatigue is medically unexplained (i.e. other diagnosis known to cause fatigue such as psychiatric disorders and cancer should be excluded);
  • Fatigue is sufficiently severe to significantly disable or distress the patient; and
  • Fatigue has persisted for at least six months.
We will include trials which include patients with disorders other than CFS as long as more than 90% of the patients had a primary CFS diagnosis according to the criteria above. Trials in which less than 90% of participants had a primary diagnosis of CFS will only be included in the analysis of this review if data for CFS are reported separately.
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The criteria they say they are going to use for CFS are all about fatigue, in other words, although they mention PEM at the beginning of the paragraph, it doesn't appear in the criteria. So a sneaky reintroduction of Oxford criteria?

And the primary outcome, unsurprisingly is fatigue questionnaires.
 
Trying to get my head around all the Cochrane reviews for CFS, I think we now know the following:

Exercise reviews:
1A. Cochrane review Exercise for CFS, published 2014, updated several times, by Larun et al is still standing.

1B. New review with Hilda's patient advisory group and review team stalled without even publishing a protocol, and promised updates not happening

Individual data exercise reviews:

2A. Cochrane review Exercise for CFS Individual data by Larun et al with review team including PACE and other trial authors, started 2014. Protocol withdrawn 2018
https://www.crd.york.ac.uk/PROSPEROFILES/107473_PROTOCOL_20211031.pdf

2B. New review not under the Cochrane banner with author team led by Larun no longer including PACE and other trial authors. Protocol based on withdrawn Cochrane protocol above, registered on PROSPERO 2018, updated 2022
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018107473
Reported as ongoing in
The Lancet New NICE guideline on chronic fatigue syndrome: more ideology than science?
Signe A. Flottorp, Kjetil Brurberg, Per Fink, Hans Knoop, Vegard B B Wyller

author disclosure states:
  • KGB reports "he is currently involved in the work with a review based on individual patient data that is about CFS/ME and exercise therapy
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Also reported as upcoming in the White et al critique of the NICE guideline:
see Lucibee's post here
The forthcoming individual patient data meta-analysis of exercise therapy trials for CFS/ME is a further step in the right direction.45

45 Larun L, Odgaard-Jensen J, Brurberg KG, et al. Exercise therapy for chronic fatigue syndrome (individual patient data).
PROSPERO 2018:CRD42018107473.
Available: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018107473
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__________________

CBT reviews

3A. CBT for CFS published 2008. Stiil available with advice that it's out of date and shouldn't be used.
https://www.cochrane.org/CD001027/DEPRESSN_cognitive-behaviour-therapy-chronic-fatigue-syndrome
https://www.cochrane.org/CD001027/DEPRESSN_cognitive-behaviour-therapy-chronic-fatigue-syndrome

3B. No new review plan known?

Individual data CBT review

4. CBT for CFS Individual patient data
Protocol?
Knoop disclosed he's working on this:
The Lancet New NICE guideline on chronic fatigue syndrome: more ideology than science?
Signe A. Flottorp, Kjetil Brurberg, Per Fink, Hans Knoop, Vegard B B Wyller
quoted here
Author disclosure states:
  • HK reports he "is currently preparing a review based on individual patient data of the outcomes of CBT for CFS/ME"
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Caroline Struthers said:
I might try and get it via the Norwegian Institute of Public Health (Freedom of Information).
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Good idea & good luck - thanks for chasing this.

EDIT - certainly in the UK it's a criminal offence to destroy material i.e. once a request has been made --- probably in Norway too - it's EU legislation. So interesting to see the outcome.
 
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As far as I can understand it, there was a plan by BPS proponents to analyse individual patient data in CFS exercise trials, as a Cochrane review. That horrific idea was headed off during the peer review of the protocol (thanks to those involved in that. Am I correct in assuming that this was in the era of David Tovey, the Cochrane Editor who seemed sensible?)

However, BPS proponents are still keen on the idea and seem to be proceeding towards doing the review, just not under the Cochrane umbrella. Even if it isn't officially a Cochrane review, the recycled protocol suggests that the review will have sufficient 'Cochrane' references in it (to the database, to processes and tools) that a casual reader may have difficulty identifying that.

I guess the plan may have been to head off any weakened view on the utility of exercise that may have come out of the Cochrane Exercise therapy update (the one Hilda was managing) with this review of individual patient data. So that they could say 'no evidence of harm and, look, it helps some people'.

If I haven't understood correctly, please correct me.
 
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That seems to be correct. And it's worse than just another Cochrane type review, in that they seem to be openly using the Oxford criteria, ie only fatigue needed as a symptom, so won't need to downgrade trials which used Oxford criteria for indirectness, and they are using fatigue questionnaires as their primary outcome measure. So they will be able to get the answers they want.

And there appears to be a parallel review of individual patient data for CBT for CFS, also by BPS supporters including Knoop. No doubt it will also use Oxford criteria and fatigue questionnaire outcomes.

It's incredibly dishonest to go on calling fatigue alone CFS.
 
Trish said:
It's incredibly dishonest to go on calling fatigue alone CFS.
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Yes. Would it justify a retraction or some sort of warning? It seems like a form of lying.

For clarity here's the definition of Oxford CFS criteria:

a) A syndrome characterized by fatigue as the principal symptom.
b) A syndrome of definite onset that is not lifelong.
c) The fatigue is severe, disabling and affects mental and physical functioning.
d) The symptom of fatigue should have been present for a minimum of 6 months during which it was present for more than 50% of the time.
e) Other symptoms may be present, particulalry myalgia, mood and sleep disturbance.
f) Certain patients should be excluded [I don't want to type it all out. The important part is that medical and certain psychiatric disorders conditions causing chronic fatigue are excluded, but depressive and anxiety disorders are not].

So in summary it's approximately equivalent to severe chronic fatigue and allows people whose main problem might be depressive disorder to be diagnosed as having CFS.

Given the funny definitional games the PACE authors have played, I would also want to know how the authors define "severe disabling fatigue" exactly.

I also wonder if "definite onset" would exclude those with a gradual onset.
 
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Trish said:
That seems to be correct. And it's worse than just another Cochrane type review, in that they seem to be openly using the Oxford criteria, ie only fatigue needed as a symptom, so won't need to downgrade trials which used Oxford criteria for indirectness, and they are using fatigue questionnaires as their primary outcome measure. So they will be able to get the answers they want.

And there appears to be a parallel review of individual patient data for CBT for CFS, also by BPS supporters including Knoop. No doubt it will also use Oxford criteria and fatigue questionnaire outcomes.

It's incredibly dishonest to go on calling fatigue alone CFS.
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After having their entire body or research invalidated several times on this ground alone, this is incredibly foolish and stubborn to the point of being fanatical.

Looks to me like a shift away from anything about ME/CFS and towards even more generic illness definitions based around single symptoms, under the generic umbrella of either MUS or functional disorders. Or whatever.
 
An illness definition based on a single nonspecific symptom cannot be taken seriously. It should be obvious to anyone that it's meaningless. The people behind this attempt to revive the Oxford criteria appear to intend using ME/CFS to give some credibility to this.

Even from a language point of view it makes no sense. A syndrome is a collection of symptoms. A single symptom is not a syndrome.
 
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