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Graded exercise therapy for ME/CFS is not effective and unsafe. Re-analysis of a Cochrane review (2018) Health Psychology / Vink
I haven't had time to read it all, but I can see it is a thorough analysis of why the Cochrane review is unsound. Excellent work.
The paper goes through a list of major flaws, such as subjective outcome measures in unblinded trials, too broad criteria, inadequate reporting of harms, and exclusion of a study that showed CBT/GET didn't work. Then it takes each of the trials included in Cochrane and explains the problems with them. Then it reviews evidence of harms, and finally the outcomes from objective measures.
The paper goes through a list of major flaws, such as subjective outcome measures in unblinded trials, too broad criteria, inadequate reporting of harms, and exclusion of a study that showed CBT/GET didn't work. Then it takes each of the trials included in Cochrane and explains the problems with them. Then it reviews evidence of harms, and finally the outcomes from objective measures.
Barry
Senior Member (Voting Rights)
It also potentially guilts participants into not kicking up a fuss, and to feel it must be their fault. As good a way as any to magic away reporting of harms.
rvallee
Senior Member (Voting Rights)
I think in due time this may be understood as a variant of the Milgram experiment, where people in a context where they want to comply with authority may play along with instructions that end up greatly harming them, even voicing undeserved praise about being helped while being actively harmed by professionals who should definitely know better.
Gaslighting is a seriously underappreciated concept and it's a massive shame that it is accepted as a legitimate alternative to medicine just because it makes people's job easier and seems cheaper (even though it's not even close to be).
The Cochrane review on ME will eventually be understood as an egregious case of low-quality trial laundering, bundling up a bunch of mediocre research and pretending it amounts to a level clinical significance just because it makes assertions that confirm people's biases. Unlike that it will hurt Cochrane's reputation, unfortunately. They seem to enjoy a status of near deification.
No one involved is thinking much about the future, how this will all look with hindsight. Surely they know it's all bullshit and just don't care because it validates their beliefs that ME is a fake disease. After all, if no one suffered any consequences from all the fake research showing smoking is harmless and vaporising lead into the atmosphere is safe then the worst that will happen is they'll move on to the next bullshit that will pay them for being mediocre at their job.
Gaslighting is a seriously underappreciated concept and it's a massive shame that it is accepted as a legitimate alternative to medicine just because it makes people's job easier and seems cheaper (even though it's not even close to be).
The Cochrane review on ME will eventually be understood as an egregious case of low-quality trial laundering, bundling up a bunch of mediocre research and pretending it amounts to a level clinical significance just because it makes assertions that confirm people's biases. Unlike that it will hurt Cochrane's reputation, unfortunately. They seem to enjoy a status of near deification.
No one involved is thinking much about the future, how this will all look with hindsight. Surely they know it's all bullshit and just don't care because it validates their beliefs that ME is a fake disease. After all, if no one suffered any consequences from all the fake research showing smoking is harmless and vaporising lead into the atmosphere is safe then the worst that will happen is they'll move on to the next bullshit that will pay them for being mediocre at their job.
Hell..hath..no..fury...
Senior Member (Voting Rights)
Wow, amazing to read
Esther12
Senior Member (Voting Rights)
Nice one. Thanks to the authors.
I expected it to draw more on the points made by Courtney and Kindlon in the comments section of the Cochrane review, but it's really quite different, focussing more on the problems with the studies included in the Cochrane review, so it works more as a companion piece to what has already been done than a summary of the problems with the Cochrane review.
I've only got half way through so far, but already there were a lot of sensible points, and it is really good for someone to have attempted a critical look at all the included studies like this. Reading the paper made me realise what a sensible idea doing something like this was... it must have been a lot of work.
I wondered if sometimes the fact that English is not the author's first language could have led to some slightly odd phrasing. eg:
Surely it would be possible for some patient with MS to report no more fatigue than healthy controls? I think I see the point they're going for - that it would seem the Chalder Fatigue Questionnaire can generate misleading results when those with a health condition have received a form of CBT which encourages 'positive' cognitions about fatigue, as illustrated by the seemingly implausible results from that fatigue study, but as it's written above it seems like a slightly strange argument.
I expected it to draw more on the points made by Courtney and Kindlon in the comments section of the Cochrane review, but it's really quite different, focussing more on the problems with the studies included in the Cochrane review, so it works more as a companion piece to what has already been done than a summary of the problems with the Cochrane review.
I've only got half way through so far, but already there were a lot of sensible points, and it is really good for someone to have attempted a critical look at all the included studies like this. Reading the paper made me realise what a sensible idea doing something like this was... it must have been a lot of work.
I wondered if sometimes the fact that English is not the author's first language could have led to some slightly odd phrasing. eg:
Surely it would be possible for some patient with MS to report no more fatigue than healthy controls? I think I see the point they're going for - that it would seem the Chalder Fatigue Questionnaire can generate misleading results when those with a health condition have received a form of CBT which encourages 'positive' cognitions about fatigue, as illustrated by the seemingly implausible results from that fatigue study, but as it's written above it seems like a slightly strange argument.
Sly Saint
Senior Member (Voting Rights)
"The Chalder Fatigue Scale is flawed."
"First, it does not provide a comprehensive reflection of fatigue-related severity, symptomology, or functional disability in CFS (Haywood et al., 2011), as it was developed by mental health professionals, and many questions are geared towards depression and not CFS (Chalder et al., 1993).
Second, the ceiling effect means that a maximum score at baseline cannot increase even if there is deterioration during the trial.
As a consequence, for example, if a participant deteriorated during the trial on eight items and improved on three, the score should reflect a deterioration of five points. However, if they had scored the maximum at baseline, then since eight scores cannot get worse and three scores have improved, the Chalder Fatigue Scale would classify the participant, who had deteriorated by five points, as improved by three points."
"Evidence on harms
According to the review, only two studies reported on safety or adverse reactions and in the larger (White et al., 2011) there are questions about the definition used."
"However, the claims that the interventions in White et al. (2011) are safe are based on an unrealistic definition of harms. Adverse events were considered serious when they involved death, hospital admission, increased severe and persistent disability, self harm, were life-threatening or required an intervention to prevent one of these (White et al., 2011). These are not harms normally complained of by patients."
"The failure of most studies to report on safety or adverse reactions and the unrealistic definition used by White et al. (2011) mean that it is not possible to conclude GET is safe."
"First, it does not provide a comprehensive reflection of fatigue-related severity, symptomology, or functional disability in CFS (Haywood et al., 2011), as it was developed by mental health professionals, and many questions are geared towards depression and not CFS (Chalder et al., 1993).
Second, the ceiling effect means that a maximum score at baseline cannot increase even if there is deterioration during the trial.
As a consequence, for example, if a participant deteriorated during the trial on eight items and improved on three, the score should reflect a deterioration of five points. However, if they had scored the maximum at baseline, then since eight scores cannot get worse and three scores have improved, the Chalder Fatigue Scale would classify the participant, who had deteriorated by five points, as improved by three points."
"Evidence on harms
According to the review, only two studies reported on safety or adverse reactions and in the larger (White et al., 2011) there are questions about the definition used."
"However, the claims that the interventions in White et al. (2011) are safe are based on an unrealistic definition of harms. Adverse events were considered serious when they involved death, hospital admission, increased severe and persistent disability, self harm, were life-threatening or required an intervention to prevent one of these (White et al., 2011). These are not harms normally complained of by patients."
"The failure of most studies to report on safety or adverse reactions and the unrealistic definition used by White et al. (2011) mean that it is not possible to conclude GET is safe."
Merged thread
Abstract
The analysis of the 2017 Cochrane review reveals flaws, which means that contrary to its findings, there is no evidence that graded exercise therapy is effective. Because of the failure to report harms adequately in the trials covered by the review, it cannot be said that graded exercise therapy is safe. The analysis of the objective outcomes in the trials provides sufficient evidence to conclude that graded exercise therapy is an ineffective treatment for myalgic encephalomyelitis/chronic fatigue syndrome.
Full artikel published in Health Psychology Open:
http://journals.sagepub.com/doi/full/10.1177/2055102918805187
Abstract
The analysis of the 2017 Cochrane review reveals flaws, which means that contrary to its findings, there is no evidence that graded exercise therapy is effective. Because of the failure to report harms adequately in the trials covered by the review, it cannot be said that graded exercise therapy is safe. The analysis of the objective outcomes in the trials provides sufficient evidence to conclude that graded exercise therapy is an ineffective treatment for myalgic encephalomyelitis/chronic fatigue syndrome.
Full artikel published in Health Psychology Open:
http://journals.sagepub.com/doi/full/10.1177/2055102918805187
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JemPD
Senior Member (Voting Rights)
@Mark Vink you might like to read the very warm reception to this paper on this thread 
https://www.s4me.info/threads/grade...rane-review-2018-health-psychology-vink.6097/
https://www.s4me.info/threads/grade...rane-review-2018-health-psychology-vink.6097/
Thank you for doing that; thanks everybody for all the compliments@Mark Vink you might like to read the very warm reception to this paper on this thread
https://www.s4me.info/threads/grade...rane-review-2018-health-psychology-vink.6097/
arewenearlythereyet
Senior Member (Voting Rights)
Excellent ...read the whole lot in one go ...very compelling
Simone
Senior Member (Voting Rights)
Not too late, and it’s on my list to send it by the end of the week (been really crashed this week). The timing couldn’t be more perfect, actually. This is just what we need right now.