Rethinking the treatment of chronic fatigue syndrome—A reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT

This is great news, thanks for publishing this

I'm wondering if the paper explains the lengths they went to to try and hide the data from being released? It doesn't actually matter in the annals of science but it does show their malicious intent which they are still employing in their actions today

 

Yeah.

I can't remember whether it was the CBT or GET manual or if it was both. But I remember reading that telling patients about the effectiveness / scientific evidence behind the therapy was absolutely essential for the treatment.

Manual also stated importance of patients being told to ignore negative symptoms.

Gogo super placebo!

Too fatigued to read the paper today, but looking forward to reading it later Carolyn.

 

GET participant manual in the PACE trial, page 27 and 28

The message given to participants: GET will allow you to get back to gardening, walking your kids to school, playing sports, and make you feel much better. The CMO approves of GET.

 

Don't really like the sound of "mange your home or garden" though!

 

great work !!!!!

Wilshire C., Kindlon, T., Courtney, R., Matthees, A., Tuller, D., Geraghty, K., & Levin. B.

 

Another thing which this paper clearly shows to the outside world is how all the changes were in one direction, to ensure CBT/GET had positive results ie these changes weren't random, weren't due to someone making errors in methodology or statistics, no, this was orchestrated.

 

Eeeew, sounds itchy!

 

I suspect it would have been impossible for GET participants to expect anything else. The whole objective of the intervention was to progressively increase physical function, and that expectation was deeply embedded into the treatment regime. I think it would have been much more than simply being told ... probably more akin to a progressively ingrained mantra.

 

I think it does better Alvin. It shows clearly what was not released, the impact of choosing what to release and the fact that stated reasons for decisions don't make sense.

Anyone reading the paper without prior knowledge would find it damning.

There are also parts of the paper where it is explained that maybe there is some minor miracle that would make all this criticism moot, but unfortunately the data has not been published by the original authors. It made me 'heh' a few times during reading.

It reminded me of legal decisions where a judge cannot clearly say 'this is all a load of bollocks', and so writes in a way that everyone knows what he means, like talking to an obstinate child, which can be worse than just straight exasperation.

 

Cool, i look forward to reading it

 

Many thanks to the authors

 

Fabulous.

 

Excellent and thank you so much! We are truly lucky to have you guys working on this!

Was interested to see on the front page of BMC Psychology that our old friend Dorothy Bishop is an editorial advisor https://bmcpsychology.biomedcentral.com

 

Great work - thanks to all who were involved. That was a tour-de-force.

I've got one main question, and then just a few notes I pulled out as I went through.

Does this mean that we can/can't say "using the prespecified analysis for the trial's primary outcome there was no significant treatment effect for [CBT and/or GET]"?

Or do we once again have to deal with niggling complexities which prevent a nice simple statement (ideally one suited to those of us not used to discussing Bonferroni correction)?

That is right on the edge of what they define as a clinically important difference in the full trial protocol:

"We propose that a clinically important
difference would be between 2 and 3 times the improvement rate of SSMC."

I didn't know/had forgotten that there was a date available for that. Where was that from?

I'd have liked a mention of the fact that after the 2011 Lancet paper was released, they claimed that the results for the recovery criteria laid out in their protocol were due for publication in an academic journal. [ http://www.meassociation.org.uk/2011/05/6171/ http://www.meassociation.org.uk/wp-content/uploads/2011/06/FOI+from+Queen+Mary.pdf ] I know that there are too many problems to detail in just one paper though.

There's also this quote from Sharpe from 2011:

http://www.abc.net.au/radionational...son-of-treatments-for-chronic-fatigue/2993296

I don't really understand this sentence in the paper about this:

Are you saying that the recovery definition was changed before the Lancet paper was released? Do you have access to some info on this that has not been made public, or am I misunderstanding you?

There seem to be missing italics here:

Is this 'good' justified? How good was SMC?: "Patients do just as well with some good basic medical care."

Typo: "Amore plausible explanation"

"It is
concerning that these negative findings were not
even published until years after the primary results
had been reported, so these inconsistencies are not
immediately apparent to the reader."

This reminded me that we're still waiting for some LTFU data, eg employment.

Was the decision to keep that 'merely' in there at least partly for the fun of pushing this peer reviewer to follow through on their promise to slag you off for it?

https://jcoynester.wordpress.com/20...bused-by-a-peer-reviewer-and-silenced-by-bmj/

There were so many parts I wanted to pull out and praise that I'm having to restrain myself. Although it's not a killer bit to quote, and there were other bits I enjoyed even more, I really appreciated the careful phrasing of this section, so will highlight that to remind me to steal it in future:

​

 

Great work from @Carolyn Wilshire et al. I note that Alem is listed as an author, does this mean he has recovered sufficiently to be able to take an active part in writing this paper, or is this an acknowledgment of his previous work on analysing of the PACE data?

 

Aren't the authors simply saying the PACE investigators changed how they were going to interpret the outcomes long after the outcomes data were available, thereby allowing the PACE investigators to cherry pick the most favourable interpretation methods? Or maybe I'm missing you're meaning here @Esther12.

 

Oh.... I'd read it in the colloquial sense of indicating it happened somewhere around one to two years, but you're right that it only says it did not take place in the first year after the trial was completed. Thanks Barry. I shouldn't try reading academic papers just before bed.

 

Thank you for an impressive analysis that I think will come to be seen as a very important and influential piece of work.

Somewhere on the Wolfson website PACE section, the authors state clearly that this was an exploratory analysis of recovery. My understanding is that exploratory means after seeing and experimenting with the data.

 

I'd forgotten about that:

http://www.wolfson.qmul.ac.uk/current-projects/pace-trial/#faq

They go on to say:

I couldn't see mention of 'exploratory' in the PACE recovery paper. Instead, this is the conclusion from their abstract: "Conclusions.This study confirms that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery."

 

So this was both an exploratory and prespecified?? And however they defined recovery there was always a difference - except they forgot to include their protocol definition of recovery, where there was no significant difference?!