Cochrane Review: 'Exercise therapy for chronic fatigue syndrome', Larun et al. - New version October 2019 and new date December 2024

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MEMarge

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Cochrane Review: 'Exercise therapy for chronic fatigue syndrome' 2017, Larun et al. - Recent developments, 2018-19
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[2019] Latest version published

Very low quality of evidence.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003200.pub8/full

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Discussion of the relabelling of the review with a new 2024 date starts here:
Cochrane Review: 'Exercise therapy for chronic fatigue syndrome', Larun et al. - New version October 2019 and new date December 2024
 
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Article from Cochrane
Today, Cochrane publishes an amended version of the Review, 'Exercise therapy for chronic fatigue syndrome.’ In the last nine months, this Cochrane Review has been modified by the review’s authors and evaluated by independent peer reviewers and editors. It now places more emphasis on the limited applicability of the evidence to definitions of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) used in the included studies, the long-term effects of exercise on symptoms of fatigue, and acknowledges the limitations of the evidence about harms that may occur.
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https://www.cochrane.org/news/publication-cochrane-review-exercise-therapy-chronic-fatigue-syndrome
 
MEMarge said:
Latest version published

Very low quality of evidence.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003200.pub8/full
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Not for the contested one, where it seems like Larun got her way: "There is moderate‐certainty evidence that exercise therapy was probably more effective than control in reducing fatigue at end of treatment".

And also "1.8 Self‐perceived changes in overall health
There is moderate‐certainty evidence that exercise therapy probably increases the number of people who report at least some degree of improvement in self‐perception of overall health at end of treatment"

They can emphasise that in any PR spin.
 
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They continue to classify the PACE Trial as having a low risk of bias in terms of selective reporting which is hard to accept.

This is the comment I made previously:


"Selective reporting (outcome bias)" and White et al. (2011)

I don't believe that White et al. (2011) (the PACE Trial) (3) should be classed as having a low risk of bias under "Selective reporting (outcome bias)" (Figure 2, page 15). According to the Cochrane Collaboration's tool for assessing risk of bias (21), the category of low risk of bias is for: "The study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way". This is not the case in the PACE Trial. The three primary efficacy outcomes can be seen in the published protocol (22). None have been reported in the pre-specified way. The Cochrane Collaboration's tool for assessing risk of bias states that a “high risk” of bias applies if any one of several criteria are met, including that “not all of the study’s pre-specified primary outcomes have been reported” or “one or more primary outcomes is reported using measurements, analyses methods or subsets of the data (e.g. subscales) that were not pre-specified”. In the PACE Trial, the third primary outcome measure (the number of "overall improvers") was never published. Also, the other two primary outcome measures were reported using analysis methods that were not prespecified (including switching from the bimodal to the Likert scoring method for The Chalder Fatigue Scale, one of the primary outcomes in your review). These facts mean that the “high risk of bias” category should apply.
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Much as NICE Cochrane are saying we now accept the current situation isn’t sustainable but please put up with something unfit for purpose that we will leave in place for a further extended period while we try to come up with something better.
 
"Most studies had a low risk of selection bias?"

How does that fit with AHRQ's conclusion that "Oxford case definition results in a high risk of including patients who may have an alternate fatiguing illness or whose illness resolves spontaneously with time."
 
Esther12 said:
Not for the contested one, where it seems like Larun got her way: "There is moderate‐certainty evidence that exercise therapy was probably more effective than control in reducing fatigue at end of treatment".

And "1.8 Self‐perceived changes in overall health
There is moderate‐certainty evidence that exercise therapy probably increases the number of people who report at least some degree of improvement in self‐perception of overall health at end of treatment"

They can emphasise that in any PR spin.
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I'm confused has there been an outcome/updated version to the Larun paper or not?
 
Wonko said:
Is 'probably' considered a scientific term now then?
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from the correspondence between Atle Fretheim (for the review authors) and David Tovey (Cochrane):

Some practical issues will arise, e.g. which term shall we use to reflect the grading? Usually
“probably” is used for moderate level evidence, while “may” is used for low level. We are willing to
accept “may”.
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https://www.s4me.info/threads/cochr...developments-2018-19.10030/page-4#post-179984
 


The revised Cochrane Review on ME/CFS was released today, October 2, 2019. We will share a more in-depth analysis shortly. However, we must immediately emphasize that #MEAction does not support graded exercise therapy due to serious risk of harms to people with ME, and that we are deeply concerned about the conclusions of this review.

The report’s conclusion is highly problematic:

“Exercise therapy probably has a positive effect on fatigue in adults with CFS compared to usual care or passive therapies. The evidence regarding adverse effects is uncertain. Due to limited evidence it is difficult to draw conclusions about the comparative effectiveness of CBT, adaptive pacing or other interventions. All studies were conducted with outpatients diagnosed with 1994 criteria of the Centers for Disease Control and Prevention or the Oxford criteria, or both. Patients diagnosed using other criteria may experience different effects.”

The review states:

1 "We are uncertain about the risk of serious adverse reactions [in graded exercise therapy] because the certainty of the evidence is very low.”

2. “All [studies] had a high risk of performance and detection bias."

3. "It is important to note that the evidence in this review is from people diagnosed with 1994 criteria of the Centers for Disease Control and Prevention or the Oxford criteria. People diagnosed using other criteria may experience different effects."

4. Almost all outcomes included in the review are given a ‘Certainty of the Evidence’ grade of low or very low.

How this poor evidence led Cochrane to conclude that “exercise therapy probably has a positive effect on fatigue in adults with CFS” is unknown.

Our added points:
1. The review only looks at Randomised Control Trials (RCTs) and doesn't account for patient surveys that show the high rates of deterioration following exercise therapy for ME.

2. While, there are several studies showing that exercise does harm people with ME, we do acknowledge there is not systematic evidence regarding the harms of exercise therapies. Therefore, we consider patient surveys indicating GET harms people with ME, and the growing literature around abnormal responses to exercise, the best available evidence.

You can learn more about the effects of graded exercise therapy and the effects on people with ME here:
1. #MEAction’s white paper: People with Myalgic Encephalomyelitis Show Deleterious Effects following GET and CBT
https://www.meaction.net/…/Effects-of-GET-CBT-in-people-wit…

2. A recent survey of over 2.200 people confirmed that graded exercise therapy (GET) is harming a large majority of people with ME receiving this treatment in the UK
https://www.meaction.net/…/get-and-cbt-are-not-safe-for-me…/

3. Reanalysis of the PACE trial shows GET and CBT are ineffective https://www.meaction.net/…/reanalysis-of-pace-trial-shows-…/
Recap from David Tuller of the Cochrane review saga http://www.virology.ws/…/whats-up-with-cochranes-exercise-…/

The Cochrane review can be found here: https://www.cochranelibrary.com/…/14651858.CD003200.p…/full…
 
From the latest review their assessment of selective reporting in PACE

Selective reporting (reporting bias) Low risk
The protocol and the statistical analysis plan were not formally published prior to recruitment of participants, and some readers therefore claim the study should be viewed as being a post hoc study. The study authors oppose this, and have published a minute from a Trial Steering Committee (TSC) meeting stating that any changes made to the analysis since the original protocol was agreed by TSC and signed oN before the analysis commenced.
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So they are still being very kind to PACE in terms of selective reporting where we know that protocol changes had a huge effect (after a court ordered them to release data). Also the TSC minutes were ordered to be released by the ICO and in them it is not clear who or when the stats plan was signed off and certainly not clear this was a new protocol which is how they treated it.
 
All studies were conducted with outpatients diagnosed with 1994 criteria of the Centers for Disease Control and Prevention or the Oxford criteria, or both. Patients diagnosed using other criteria may experience different effects.
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It's really impressive how Cochrane manage to dance around the actual problems of their review to avoid damaging their entire brand. The problem with the studies isn't that there exists some sort of special ME/CFS group of patients that the studies in question might not apply to. The problem is that despite using the widest possible inclusion criteria, the studies weren't even able to show actual improvement for the patients in the studies receiving CBT / GET compared with the control groups. Of course if Cochrane were to make this admission, it would render countless other reviews from Cochrane, which also rely entirely on unblinded studies with subjective outcome measures obsolete. Which would ruin their entire smug brand. So we end up with this useless concession instead.

Cochrane Reviews are recognized internationally as representing a gold standard in putting profits over patients.
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Is what people should be thinking whenever they hear about this bogus organisation from now on. Can't say I'm surprised, but also won't pretend like I'm not disgusted.
 
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Adrian said:
From the latest review their assessment of selective reporting in PACE

Selective reporting (reporting bias) Low risk
The protocol and the statistical analysis plan were not formally published prior to recruitment of participants, and some readers therefore claim the study should be viewed as being a post hoc study. The study authors oppose this, and have published a minute from a Trial Steering Committee (TSC) meeting stating that any changes made to the analysis since the original protocol was agreed by TSC and signed oN before the analysis commenced.
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So they are still being very kind to PACE in terms of selective reporting where we know that protocol changes had a huge effect (after a court ordered them to release data). Also the TSC minutes were ordered to be released by the ICO and in them it is not clear who or when the stats plan was signed off and certainly not clear this was a new protocol which is how they treated it.
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Where did you see that? When I ctrl+f it doesn't come up.
 
NelliePledge said:
Cochrane are saying we now accept the current situation isn’t sustainable but please put up with something unfit for purpose that we will leave in place for a further extended period while we try to come up with something better.
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It is important to note that the evidence in this review is from people diagnosed with 1994 criteria of the Centers for Disease Control and Prevention or the Oxford criteria. People diagnosed using other criteria may experience different effects.
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So maybe the most effective thing to do to ensure that this review goes into the dustbin of history is to get a Cochrane review done on studies of exercise therapy that selected people with ME/CFS (ie with PEM)? Is anyone working on that? I think there was talk about it.
 
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