A general thread on the PACE trial!

Fair enough.

However, their actual results (per protocol) fell a long way short of the assumptions for the trial:

 

This was in the Protocol:

ETA: Date of approval was 31 Mar 2003 according to http://www.isrctn.com/ISRCTN54285094

 

Just to add, the research ethics committee doesn't provide "ethical approval" (despite what the Protocol says). They provide assurance to the sponsor (QMUL) that their researchers broadly seem to be following ethical guidelines, as far as they can tell.

ETA: I guess what I'm trying to say is that they hold no responsibility as such over the trials they provide with a "favourable opinion".

 

Who does take responsibility then, and formally provide such approval?

 

Overall, the university (QMUL) takes responsibility, as the sponsoring organisation.

However, since 2015, the NHS Health Research Authority provides approval for clinical studies and oversees ethics and whatnot.

 

https://twitter.com/user/status/1072508738748276736

 

https://twitter.com/user/status/1073383846320713729

 

This drama should have ended two years ago!

 

Beat me to it. And still it drags on!

 

It should have ended the day The Lancet published a paper in which participants could meet outcome thresholds (being "within normal range") at baseline.

 

That is so very true.

 

So very true x2!

 

I’m quite new to this. I postponed reading the actual PACE trial documents until recently. What struck me is how bad the results are even if you were to take everything the PACE-authors said for granted.

Take for example CBT: null results for the 6 min walking test, the step-fitness test, levels of disability benefits, insurance payments and days of employment. There was only a significant result on subject measures such as fatigue and physical function (if you were to believe the PACE authors) but those disappeared at long term follow-up.

Following the PACE-saga by reading blogs and news articles I very much got the impression that PACE proved that GET and CBT worked, but that there were so many flaws in the trial that these results cannot be trusted. Therefore we needed to get rid of it: a full retraction of PACE papers and its misleading message.

By reading the actual results, I’ve got a very different impression. Now I see that PACE actually proved that CBT and GET do not work in ME/CFS. There were a couple of smaller and poorly designed RCT’s that came before it, finding that these treatments could improve subjective outcomes. But PACE, being the larger and better designed study - conclusively showed that these do not represent clinical meaningful changes: subjective improvements after GET/CBT are not only very small (virtually nonexistent in the analysis according the original protocol), they disappear at follow-up, patients remain very sick and there is no improvement on multiple objective outcomes. The questionable outcomes switching by the PACE authors doesn’t actually change much to that conclusion.

As I see it, the fiercest proponents of GET and CBT received the ultimate opportunity to prove their favored therapies are effective. They had millions of pounds to do it. They’ve got to select patients according to their bogus criteria, they didn’t have to provide an adequate control arm, they could choose the outcomes measures they want and they even were allowed to send participants a letter claiming GET and CBT are effective. And despite all of that, there were no results for both these treatments.

So now I see PACE differently; as the definite proof that GET and CBT do not work. And I think I’m going to use it in advocacy more (especially regarding CBT as some psychologists in Belgium seem willing to dump GET to save CBT at the moment), without waiting for The Lancet and the other journals to correct the unacceptable outcome switching and other flaws.

Just to be clear: I do not wish to minimize the amazing work by the patients/scientists who exposed the many flaws of the PACE-trial (you guys are my heroes). In fact I think the exposure of these flaws very much changed the field of ME/CFS in the last couple of years. It showed the outside world how unscientific and irresponsible BPS proponents are and it drew many 'outsiders' (Tuller, Coyne, Hughes etc.) into the field getting ME/CFS attention in the news and scientific community and so much more.

I just wanted to suggest that maybe we could already use PACE more in advocacy as the definite proof GET and CBT do not work, even as things stand for the moment. I would love to hear what the more experienced forum members think of this.

Cheers,

 

I think most of the 'old timers' would agree, especially Tom.

The only Catch22 is that if they frightened off all the people with real ME and only studied people without ME then they did't even prove the treatments did not work in ME because they did not study it. It takes quite a stretch to see why they should work in real ME but there is a hint of cherry-picking about saying they nailed the disproof when the methodology was so bad it could not disprove anything much!

 

Didn't they just sort of disprove their methods work for anything that could have been included by the selection criteria (whatever that may have been) and now the onus would be on whoever still wants to find out if their 'treatments' are ever of any use whatsoever to find exceptions to that rule?