Yes, revising medical textbooks and national CFS treatment guidelines is clearly top priority.
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Alem Matthees analyses on released PACE data blast "recovery" claims - huge damage to PACE
- Thread starter user9876
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Yes, revising medical textbooks and national CFS treatment guidelines is clearly top priority.
trishrhymes
Senior Member
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Can you give a link to Bad Science. I tried googling it but all I got was Ben Goldacre's blog.
worldbackwards
Senior Member
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Sure:
http://www.badscience.net/forum/viewtopic.php?f=3&t=34704&hilit=cfs pace
It gets interesting about halfway down the first page, which is where the discussion of the Virology pieces begins. Although it may be worth perusing quite how dismissive of Charles and the others they are at the top.
Daisymay
Senior Member
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- 754
With the analysis of the data as per the protocol, I thought I'd look again at Professor Sir Simon Wessely's article from last November in Mental Elf, where he defended the trial, using the analogy of HMS PACE.
It was embarrassing enough then, it's even more so now......
Here are some snippets from it in case of interest:
http://www.nationalelfservice.net/o...choppy-seas-but-a-prosperous-voyage/#comments
The PACE Trial for chronic fatigue syndrome: choppy seas but a prosperous voyage
Professor Sir Simon Wessely 4th November 2015
"In this blog I will argue that HMS PACE did make it successfully across the Atlantic. Small corrections to the route taken were made on the way, but these were of little significance. The fundamental mechanics of the ship remained water tight and at no time were the ship or its passengers in peril until it safely docked exactly where it was supposed to."
"..... I am well informed about clinical trials in general, and about the issues that surround chronic fatigue syndrome in particular. I have previously made it clear that I think that PACE was a good trial; I once described it as a thing of beauty. In this blog I will describe why I still think that and I will try and avoid very technical issues, which have been addressed by the investigators on many occasions."
"It (PACE) has already been used as an example of how to conduct a large complex intervention, and has been cited 219 times in Scopus. But of course it has also been subjected to what in my experience is an unprecedented campaign of criticism, which sometimes has merged into something approaching vilification that goes well beyond a reasoned scientific critique."
"e. Changes to original protocol
The researchers changed the way they scored and analysed the primary outcomes from the original protocol.
The actual outcome measures did not change, but it is true that the investigators changed the way that fatigue was scored from one method to another (both methods have been described before and both are regularly used by other researchers) in order to provide a better measure of change (one method gives a maximum score of 11, the other 33). How the two primary outcomes (fatigue and physical function) were analysed was also changed from using a more complex measure, which combined two ways to measure improvement, to a simple comparison of mean (average) scores. This is a better way to see which treatment works best, and made the main findings easier to understand and interpret. This was all done before the investigators were aware of outcomes and before the statisticians started the analysis of outcomes. The changes were approved by the two independent oversight committees. The very detailed analysis plan, including these changes, was published, and these changes and the reasons for them were also described in the main paper."
"Conclusion
No trial is perfect. Nothing as complex as a multi-centre trial (there were six centres involved), that recruited 641 people, delivered thousands of hours of treatment, and managed to track nearly all of them a year later, can ever be without some faults. But this trial was a landmark in behavioural complex intervention studies. That is why it survived all the independent scrutiny as it progressed, survived the rigorous review processes of one of the world’s top medical journals, which rejects nearly all the papers it receives, and this is why it has already been cited in over 200 medical publications. But even then, one trial does not a summer make, and one needs to see it as part of the totality of similar trials before and since."
..................................
And now, in Juile Rehmeyer's excellent article https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/ when asked about the re-analysis and the lack of recovery with CBT/GET, Professor Sir Simon Wessely, President of the Royal College of Psychiatrists, said:
“OK folks, nothing to see here, move along please.”
He still doesn't have the grace/sense/ integrity to concede how seriously flawed the trial was.
Self preservation, loyalty to his peers and the BSP ideology would seem to take absolute precedence over any notion of scientific integrity and certainly patient safety.
It was embarrassing enough then, it's even more so now......
Here are some snippets from it in case of interest:
http://www.nationalelfservice.net/o...choppy-seas-but-a-prosperous-voyage/#comments
The PACE Trial for chronic fatigue syndrome: choppy seas but a prosperous voyage
Professor Sir Simon Wessely 4th November 2015
"In this blog I will argue that HMS PACE did make it successfully across the Atlantic. Small corrections to the route taken were made on the way, but these were of little significance. The fundamental mechanics of the ship remained water tight and at no time were the ship or its passengers in peril until it safely docked exactly where it was supposed to."
"..... I am well informed about clinical trials in general, and about the issues that surround chronic fatigue syndrome in particular. I have previously made it clear that I think that PACE was a good trial; I once described it as a thing of beauty. In this blog I will describe why I still think that and I will try and avoid very technical issues, which have been addressed by the investigators on many occasions."
"It (PACE) has already been used as an example of how to conduct a large complex intervention, and has been cited 219 times in Scopus. But of course it has also been subjected to what in my experience is an unprecedented campaign of criticism, which sometimes has merged into something approaching vilification that goes well beyond a reasoned scientific critique."
"e. Changes to original protocol
The researchers changed the way they scored and analysed the primary outcomes from the original protocol.
The actual outcome measures did not change, but it is true that the investigators changed the way that fatigue was scored from one method to another (both methods have been described before and both are regularly used by other researchers) in order to provide a better measure of change (one method gives a maximum score of 11, the other 33). How the two primary outcomes (fatigue and physical function) were analysed was also changed from using a more complex measure, which combined two ways to measure improvement, to a simple comparison of mean (average) scores. This is a better way to see which treatment works best, and made the main findings easier to understand and interpret. This was all done before the investigators were aware of outcomes and before the statisticians started the analysis of outcomes. The changes were approved by the two independent oversight committees. The very detailed analysis plan, including these changes, was published, and these changes and the reasons for them were also described in the main paper."
"Conclusion
No trial is perfect. Nothing as complex as a multi-centre trial (there were six centres involved), that recruited 641 people, delivered thousands of hours of treatment, and managed to track nearly all of them a year later, can ever be without some faults. But this trial was a landmark in behavioural complex intervention studies. That is why it survived all the independent scrutiny as it progressed, survived the rigorous review processes of one of the world’s top medical journals, which rejects nearly all the papers it receives, and this is why it has already been cited in over 200 medical publications. But even then, one trial does not a summer make, and one needs to see it as part of the totality of similar trials before and since."
..................................
And now, in Juile Rehmeyer's excellent article https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/ when asked about the re-analysis and the lack of recovery with CBT/GET, Professor Sir Simon Wessely, President of the Royal College of Psychiatrists, said:
“OK folks, nothing to see here, move along please.”
He still doesn't have the grace/sense/ integrity to concede how seriously flawed the trial was.
Self preservation, loyalty to his peers and the BSP ideology would seem to take absolute precedence over any notion of scientific integrity and certainly patient safety.
Large Donner
Senior Member
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There is still one more challenge to the notion that "pacing stlll came of worse", and that is that the pacing strategy used in the pace trial was not that practiced by patients.
It's even questionable if APT wasn't actually some form of graded exercise encouragement.The APT patients in the PACE trial would have been very aware that the investigators were claiming that CBT and GET were actually the best and proven treatments so its very likely that the APT given to them had a notion built in that "pacing to much isn't good for you and one has to find a suitable pacing limit".
Otherwise known as GET!!
I am sure this has been addressed on this forum and many other places a number of times.
alex3619
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The problems are numerous and unfixable. Even if a paper is retracted there can be analysis papers that rework the data that are published. What I want to know is, if the PACE papers are retracted, what happens to the Cochrane reviews? They should also be retracted. Without the PACE results the claims to any substantive evidence base vanish.
alex3619
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I think it was. It qualifies in many ways as anti-pacing. That is still a form of pacing, right?
Large Donner
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Have you noticed how they fast track the retractions when a paper makes any association with RVs and illnesses. Funny that, regardless of how good or bad such papers were.
Large Donner
Senior Member
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It's an incompetent fraud cos its not even a good one.
Stewart
Senior Member
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What a magnificently condescending - and unintentionally hilarious given the recurring Naked Gun joke, which he can't have been aware of - dismissive comment for him to make.
I don't normally approve of trolling but if anyone wants to post this picture (or even better a gif version) on twitter and tag Wessely to make sure he sees it, I'd be prepared to make an exception. It's just too appropriate not to.
#HMSPaceAbandonShipAllHands
Large Donner
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PACE as published in the LANCET can easily be retracted and the original protocol paper could potentially be "republished" to show as you say above. It should also carry objective info and include information on the fact that there was a zero return to work or normal activities, yet another criteria from the original protocol that White and co managed to.
PACE as published in the Lancet, and the subsequent claims made around it in the media, is a fraud and needs to be retracted and at the least a civil prosecution has to be made.
We simply cannot allow anything regarding PACE to stand now that we know there is a zero recover rate and statistically insignificant improvement rate.
We still do not have info on the deterioration rates and real adverse affects. Until such time as these other things are analysed anything relating to PACE as published in the Lancet should be immediately retracted.
Its a serious issue that deterioration rates is not being discussed and the public policy can just ignore such potential unknown harms when its obvious that the PACE investigators have committed an obvious fraud.
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alex3619
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Fraud or not, it fooled most of the medical profession and health bureaucrats for half a decade. Which is even more alarming, since many of the faults are blatantly obvious, though some are more subtle or require further investigating, including outside references. It demonstrates that very few medical "authorities" have the skillset I would require as minimally acceptable. This is a pervasive issue in medicine.
Esther12
Senior Member
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APT included telling patients to only do 70% of what they thought they comfortably could.
To me it seems unreasonably restrictive. Why have any therapists telling patients how to live their lives when they have no idea what they're talking about?
Large Donner
Senior Member
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PACE as published in the LANCET can easily be retracted and the original protocol paper could potentially be "republished" to show as you say above. It should also carry objective info and include information on the fact that there was a zero return to work or normal activities, yet another criteria from the original protocol that White and co managed to.
PACE as published in the Lancet, and the subsequent claims made around it in the media, is a fraud and needs to be retracted and at the least a civil prosecution has to be made.
We simply cannot allow anything regarding PACE to stand now that we know there is a zero recover rate and statistically insignificant improvement rate.
We still do not have info on the deterioration rates and real adverse affects. Until such time as these other things are analysed anything relating to PACE as published in the Lancet should be immediately retracted.
Its a serious issue that deterioration rates is not being discussed and the public policy can just ignore such potential unknown harms when its obvious that the PACE investigators have committed an obvious fraud.
Large Donner
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It depends really what the known consequences could reasonably have been expected to be. Lets not forget also there is the issue of deterioration rates.
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A.B.
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If the adverse events were not recorded, we will never find out. There were several mechanisms in place to obscure adverse events (I'm avoiding specifics due to memory issues at the moment).
Yeah, it's pretty disgusting.
Kati
Patient in training
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Cochrane reviews are most damaging since many physicians from around the world guide their interventions on those reviews.
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