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"News" 8 Sep 2016: PACE trial team analyse main outcome measures according to the original protocol

Esther12

Senior Member
Messages
13,774
I've just had to edit a load of my posts after somehow thinking that the percentage figure would be higher than the participant figure, even thought the groups were 160 each... oh dear.

These figures are pretty bad for PACE then. They must feel truly backed into a corner to be trying to present this as not showing any change to their earlier claims.
 

worldbackwards

Senior Member
Messages
2,051
No, strangely not - even though the protocol clearly specified how to calculate recovery.

But it's worth noting that fewer "improved" according to the protocol than "recovered" according to the authors' revised recovery criteria. And the gap with SMC was smaller. (2013 recovery paper claimed 22% for CBT/GET, 8% for SMC).
So on that basis, we'd have to expect recovery to come in at about a third or less than the earlier 22%?
 

worldbackwards

Senior Member
Messages
2,051
I think that whatever this shows, the only claims they might possibly continue to make is that there are a small subgroup managing their illness badly that can be corrected with CBT/GET.

Add in the FINE patients who didn't improve at all and this shows that well above 90% of ME Chronic Fatigue patients get no effect whatsoever from these treatments. It's hardly a shop window.
 
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medfeb

Senior Member
Messages
491
Thank you for the update Simon.

I would like to add that it's important to serially remember (burn it into your synapses) the PACE trial study participants of the trial did not meet Fukuda CDC criteria CFS, which is the established criteria in use today.

I agree that PACE used a definition that describes chronic fatigue, not the disease described by CCC. They claim they also assessed by Fukuda but as Tuller's article noted, that was a post selection subsetting. Additionally, they used a modified Fukuda that only required symptoms for 1 week, not 6 months, which they acknowledged might not be accurate.

No matter what claims they make, their claims do not apply to patients described by the CCC or even by the IOM report. The AHRQ Addendum found insufficient evidence of effect for CBT and GET once you eliminated Oxford studies.
 

Esther12

Senior Member
Messages
13,774
I see this as an attempt to control the narrative rather than a sign that they won't release the data. In fact, I think this indicates that they will release the data - and I think tomorrow was their last day to appeal.

They've not released the recovery data, and that's what will cause them the most trouble. If this was an attempt to get their presentation of pre-specified analyses out before others got the data they'd have included recovery outcomes imo. I think that this is an attempt to avoid some of the blow back from the scientific community that they're expecting when they appeal.
 

Cheshire

Senior Member
Messages
1,129
They've not released the recovery data, and that's what will cause them the most trouble. If this was an attempt to get their presentation of pre-specified analyses out before others got the data they'd have included recovery outcomes imo. I think that this is an attempt to avoid some of the blow back from the scientific community that they're expecting when they appeal.
They are freaking, that's a very good sign. Desperate attempt to try to master a narrative they won't control for long.
 

TiredSam

The wise nematode hibernates
Messages
2,677
Location
Germany
The fact that they are able to do an "analysis" at all helpfully demonstrates that the data is still available and intact, thus preventing them from using the "Gremlins Defence".

Why are they doing this? Because they hope it will help them when they appeal? Because they hope it will help them when an action is brought for contempt of court for not releasing the data? Because they hope it will pre-empt and deflate criticism from real scientists when they finally get to analyse the data? Who knows, but whatever their desperate plan is, the chances are they have shot themselves in the foot with their own incompetence once again.
 

Gijs

Senior Member
Messages
691
They've not released the recovery data, and that's what will cause them the most trouble. If this was an attempt to get their presentation of pre-specified analyses out before others got the data they'd have included recovery outcomes imo. I think that this is an attempt to avoid some of the blow back from the scientific community that they're expecting when they appeal.

This is the most important thing. The fact they didn't present these calculations says a lot. But still they must release the data to Alem!
 

snowathlete

Senior Member
Messages
5,374
Location
UK

Just some minor exploratory analysis. nothing of interest here. no one forced our hand on this. Honest.

Funny thing is that they might have got away with that a couple of years ago but everything they've done has created so much wider interest in it that you just can't bury this data now. This is big news and if the data follows and we can see Recovery we're going to see exactly how bad it is.
 

user9876

Senior Member
Messages
4,556
There were 32 patients who improved with CBT (20%) yet the recovery paper claimed that all those 32 (22%) also recovered. 44 (30%) were now within the normal range for physical function and fatigue. And 77 CBT patients (54%) no longer met the oxford criteria.
 

A.B.

Senior Member
Messages
3,780
The fact that they are able to do an "analysis" at all helpfully demonstrates that the data is still available and intact, thus preventing them from using the "Gremlins Defence".

Why are they doing this? Because they hope it will help them when they appeal? Because they hope it will help them when an action is brought for contempt of court for not releasing the data? Because they hope it will pre-empt and deflate criticism from real scientists when they finally get to analyse the data? Who knows, but whatever their desperate plan is, the chances are they have shot themselves in the foot with their own incompetence once again.

We will see if they appeal. If they do, then they are almost certainly hoping that this controlled release will disarm critics.

It's important that people don't get carried away just yet. I think an independent analysis of PACE will be much more damning, and we should not be content with letting PACE authors interpret their own results, regardless of the protocol used.

Tuller already pointed out how they don't talk about recovery.

They also don't talk about the missing actimetry data(!), and again emphasize subjective outcomes. Their claims about adverse events are still at odds with patient experience. There are many unanswered questions still, and it's likely that every question answered will only make PACE look even worse. They're still not critically evaluating these interventions.

So continue to push for an independent analysis regardless of what happens.
 
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Sean

Senior Member
Messages
7,378
Additionally, they used a modified Fukuda that only required symptoms for 1 week, not 6 months, which they acknowledged might not be accurate.

No matter what claims they make, their claims do not apply to patients described by the CCC or even by the IOM report. The AHRQ Addendum found insufficient evidence of effect for CBT and GET once you eliminated Oxford studies.
Three very important points there.

They have to also supply the recovery and the 2.5 year follow-up figures according to the original published protocol.