Sept 2016 Wessely comment under Rehmeyer's Stat article on PACE

Esther12

Esther12

Senior Member (Voting Rights)
I thought this was worth reposting for people who may have missed it at the time.

He says "the PACE trial remains an excellent trial and a model of how to deliver a complex intervention RCT." What's most worrying about this is that he was President of the Royal College of Psychiatrists, and had some influence. All that extra funding for mental health research? How much of it is going on junk-science based on the 'model' of PACE?

What an intro it is too.

https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/comment-page-6/#comments

Simon wessely
September 23, 2016 at 5:38 am


Sorry to spoil the party but some cold facts are necessaey
1. The PACE trial remains an excellent trial and a model of how to deliver a complex intervention RCT. Read the 2012 Lancet paper again. Check it against the CONSORT statement. You will see it is 100% compliant.
2. Nothing at all has emerged to alter or contradict its key findings. These are that two treatments (CBT and GET) are superior to two others (pacing and standard medical treatment). All four approaches are safe. The effects of CBT and GET are modest but still,worthwhile especially as at moment and for the last 25 years there has been nothing better
3. As others note this does not speak to the causes of CFS but only to management. For avoidance of doubt all the serious clinicians and academics who work in this area know this is genuine condition that causes much misery to patients, friends and family.
4. Clearly we need better treatments but until and unless we do, doctors can safely recommend CBT and GET to patients. Indeed they could and did before PACE – it’s findings were entirely congruent with the previous literature, just that PACE was larger. In my country (UK) there was already sufficient evidence to recommend both therapies in our NICE guidelines before PACE was published. PACE will not be retracted because there is no reason to do so, it is fully CONSORT compliant and so on, but if it had not happened the guidelines would remain the same.

I have written a commentary here on the main PACE paper outlining the basic principles of a sound RCT and why PACE more than adheres to them
http://www.nationalelfservice.net/o...syndrome-choppy-seas-but-a-prosperous-voyage/

I realise that this will not be a popular post. That’s sad. But I think people need to know there is another story here and one that might explain why it is that people continue to cite the Lancet paper and why it’s results whilst not earth shattering are sound.

Finally I should add that I played a part in early days of developing CBT as a management approach to CFS, carried out one of the early RCTs and so on, and know personally all the PACE authors. I am not therefore neutral on this topic, and I continue to recommend CBT to my patients with CFS if they want it. I was not however an author on the PACE study .

Simon Wessely
Click to expand...

He then responded to Dave's comment:

Dave
September 23, 2016 at 6:06 am


I can sympathize with your spirited defense of your colleagues, but it seems to me that despite your long post, you’ve carefully avoided the main point Rehmeyer specifically asked you to address–how radically the “recovery” statistics changed when the authors weakened the criteria from their original protocol, and the failure to disclose this until forced by a tribunal. What do you make of that?
Click to expand...

Simon wessely
September 23, 2016 at 7:13 am


Dave, all of this has been covered extensively in the trial FAQs here http://www.wolfson.qmul.ac.uk/current-projects/pace-trial/#faq. Nothing dodgy and nothing to hide. It is perfectly acceptable to make changes to your analytic plan or indeed protocols during the conduct of a trial so long as you explain why, get TSC/DMEC approval, document it fully and make it clear in the publication. All of that was done. The 2012 Lancet paper doesn’t deal with recovery anyway, that was covered in a secondary later publication. In essence though they decided they were using a overly harsh set of criteria that didn’t match what most people would consider recovery and were incongruent with previous work so they changed their minds – before a single piece of data had been looked at of course. Nothing at all wrong in that- happens in vast numbers of trials. The problem arises, as studies have shown, when these chnaged are not properly reported. PACE reported them properly. And indeed I happen to think the changes were right – the criteria they settled on gave results much more congruent with previous studies and indeed routine outcome measure studies of which there are many. And re analysis proves the wisdom of that to be honest. But even then, using criteria that were indeed incongruent with previous work and clinical routine outcome studies, the overall pattern remains the same. CBT GET superior to pacing SMC. Most people who work in the field agree with them by the way – the criteria in the recovery paper itself (not the main lancet paper which never dealt with ) approximate with all the previous work – reasonable and meaningful but not the new penicillin. Am not going to respond to more comments on the same lines except to say it’s very likely that this has been addressed before and covered in previous responses by the authors and the trial FAQs. If you want to use the original recovery criteria you can, but I think that the ones that the trialists finally decided upon are more realistic to patients and clinicians alike . And finally it’s not a surprise that if you use extremely harsh criteria you get lower frequencies- no one has pointed out that the original criteria did indeed give recovery rates for Pacing and SMC that are also pretty daft and don’t match patient experience of either. People do get better on pacing and even just TLC- it’s just that more get better with GET and CBT, but still not enough. OK, enough already. Back to day job.
Click to expand...

This bit got picked up on, but he never explained it:

"In essence though they decided they were using a overly harsh set of criteria that didn’t match what most people would consider recovery and were incongruent with previous work so they changed their minds – before a single piece of data had been looked at of course."

Anyway, it looks very much like they had looked at trial data before deciding that they would not release results for the recovery criteria that they laid out in their trial protocol, as in response to an FOI request for these results after the Lancet paper came out in 2011 they said that this information was exempt from the FOIA act, as the result were due to be released 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
 
Jonathan Edwards said:
Perhaps the fact that he did not put his name to the reply to Nature indicates that he realises that me may not get away with it now without looking a fool.
Click to expand...

It may also be the location of the comment. He probably only cares about how certain groups of professionals view him and his image so commenting on a blog is safe but writing to nature is a different thing. I get the impression he does back channel lobbying of journalists.
 
3. As others note this does not speak to the causes of CFS but only to management
Click to expand...
So why the bold claims of recovery?

And PACE was not predicated on whatever the original cause of the ME/CFS was, but the ongoing maintenance of sympoms being due to deconditioning. That statement is just misdirection and meaningless. Probably intended to sound convincing to those (too many unfortunately) who don't know better.
 
Barry said:
So why the bold claims of recovery?

And PACE was not predicated on whatever the original cause of the ME/CFS was, but the ongoing maintenance of sympoms being due to deconditioning. That statement is just misdirection and meaningless. Probably intended to sound convincing to those (too many unfortunately) who don't know better.
Click to expand...

I've read a few of Wessely's papers and they always struck me as having logical inconsistencies of big jumps in reasoning. I did think if someone were to formalize the arguments being made then they would become obvious. It can be a case of style over substance - there is a reason maths is the language of science and engineering.
 
Adrian said:
I've read a few of Wessely's papers and they always struck me as having logical inconsistencies of big jumps in reasoning.
Click to expand...

I once read a paper about Authoritarians having a problem with syllogisms. (can't remember where)

The example was

Fish swim in the sea.
Sharks swim in the sea.
Therefore, sharks are fish.
 
You must log in or register to reply here.
Back
Top Bottom