(UK) Bristol talk on April 2 by Peter White: "Lessons from the PACE trial"

[Min]

I wonder if Action for ME, the Bristol based charity who supplied advisors and observers for the PACE trial, although they now refuse to discuss their participation, will be attending?


The PACE Trial researchers stated:

"Actigraphy is a measure of physical activity, measured by a wrist watch sized accelerometer, worn around the ankle continuously for a week. Before we started the trial, we were advised that the number and scope of the outcome measures were too great and that it might reduce the proportion of participants making it through to the end of the trial. Actigraphy was the obvious measure to reject because of its burden in time and effort required by participants. The patient charity advising us agreed that this would be sensible."

https://www.facebook.com/actionforme/posts/10151346244973209

 

[biophile]

"Actigraphy is a measure of physical activity, measured by a wrist watch sized accelerometer, worn around the ankle continuously for a week. Before we started the trial, we were advised that the number and scope of the outcome measures were too great and that it might reduce the proportion of participants making it through to the end of the trial. Actigraphy was the obvious measure to reject because of its burden in time and effort required by participants. The patient charity advising us agreed that this would be sensible."

"Actiwatch can be worn for long periods of time by subjects of all ages and any health status."

www.salusa.se/Filer/Produktinfo/Aktivitet/TheActiwatchGuidetoGettingStartedV7.2.pdf

Here is a photo of the same 'Actiwatch Plus' model used in the PACE Trial:

http://www.sen-instytut.pl/sleep_laboratory.html

I suspect that the actigraphy results would have been more burdensome on previous claims made about rehabilitative CBT/GET increasing activity levels, than on the trial participants wearing them. Actigraphy was dropped after a bunch of questionnaires were added to the earlier protocol, which were relatively superfluous compared to the actigraphy which would have shed light on the most controversial aspect of CBT/GET ie presumed increase in activity levels. Note that previous smaller CBT/GET trials using actigraphy showed no such increases in activity. Coincidence?

 

[Ambrosia_angel]

Is there anyone willing to record this talk?

 

[biophile]

No frank seminar on ME or CFS, particularly anything discussing rehabilitative CBT/GET in the context of positively reversing the pathophysiology and disability, should begin without some variant of this pie chart:

http://jangosteve.com/post/380926251/no-one-knows-what-theyre-doing

 

[Tom Kindlon]

I hope somebody who attended will give some feedback (feel free to PM me if for some reason you don't want to post publicly).

 

[user9876]

Someone has posted photos of slides

https://www.dropbox.com/sc/h6c4d3l7zmuwunl/iB2mvmlDCn#/

I notice that in talking about recovery he doesn't mention what the thresholds are.
He also attributes lack of acceptance to patients fear of being labelled with a mental illness rather than being due to his very poor research methodology and his blatant spinning of results.

I also noticed that he has dropped the 'moderately' in his claims of effectiveness and is now claiming just claiming CBT and GET are effective.

Also one of his conclusions
"Pushing limits is better than staying in the limits"

 

[biophile]

Thanks user9876. Of course, we do not know what he actually said, judging from the photos. But I imagine it would have been awkward for White to include thresholds in the slides, as the audience may figure out that the thresholds for his normal range in fatigue and physical function in a later slide overlap with an earlier slide about 'chronic disabling fatigue'.

There is a slide on informal care (small difference) and lost employment hours (no difference). I wonder if he told the audience that total service use showed no differences, or that welfare dependency actually increased during the trial.

It is interesting that he showed a slide of the Wiborg paper. I wonder how that was spun in context with the PACE Trial. Or if he mentioned that he abandoned the opportunity to collect similar data which discredits a pillar of GET.

The slides about "Good news?", "Some patient groups' reactions", "Why the anger?", "Nocebo effects?", and the mind-body stuff were a little irritating and missed the point. He also forgot to include "Why does your normal range overlap with your trial definition for chronic disabling fatigue" in the slide on patient frustration. So many other criticisms have been leveled against the trial, that regardless of their validity, he is probably not aware of them all.

In the time he spent on preparing and giving this presentation, he could have analyzed the trial data for protocol-defined positive outcomes and recovery. If he wants patients to accept his claims about recovery, he needs to publish the results using a comprehensive and conservative definition of recovery. Better late than never. The same could be said for actigraphy, which could be collected in the 5 year followup that is due in about a year or so.

 

[alex3619]

No frank seminar on ME or CFS, particularly anything discussing rehabilitative CBT/GET in the context of positively reversing the pathophysiology and disability, should begin without some variant of this pie chart:

http://jangosteve.com/post/380926251/no-one-knows-what-theyre-doing

What about stuff you think you know but is wrong?

 

[Sean]

The same could be said for actigraphy, which could be collected in the 5 year followup that is due in about a year or so.

If Action for ME can be convinced to publicly admit their mistake and ask for actigraphs to be used at 5 year followup, the PACErs would be struggling to come up with a good reason to refuse, especially as they already have complete baseline data.

 

[Esther12]

Slide 2:

The main trial questions:

Which of the four currently available treatments are most effective?

So originally 'Standardised Medical Care' was a clear control group, then it became 'Specialist Medical Care' that was provided to all patients... now the PACE results are being presented as if SMC was a comparable treatment to CBT and GET? [Although to be fair - he does actually detail the differences in therapist time later]

Slide 1:

Chronic Fatigue Syndrome:

Chronic disabling fatigue & related symptoms, with no alternative explanatory diagnosis

Slide 17:

Definition of recovery:

Normal range for both fatigue and physical function

I rather doubt that he did explain that their post-hoc claims about the 'normal range for both fatigue and physical function' would include patients who were classed as having "Chronic disabling fatigue" at the start of the trial.

I wonder what he said about the Wiborg data (thanks to whoever posted the slides - any report would be appreciated too).

Quoting unreasonable patient charities:

"that the trial has shown the therapies to be safe and effective... is extremely worrying"

I bet that is a fair representation of what they said! I couldn't find it in context. It may have been taken from here, and totally rearranged:http://www.meassociation.org.uk/2011/02/me-association-press-statement-on-the-pace-trial-results/

The final section looks like exactly the sort of drivel we expected.

Also, this talk looks to be similar in places to the one described here: http://wmmeg.weebly.com/uploads/4/8/6/8/4868611/120424_-_brief_report_on_bacme_conf_2012.pdf

 

[Dolphin]

In the time he spent on preparing and giving this presentation, he could have analyzed the trial data for protocol-defined positive outcomes and recovery. If he wants patients to accept his claims about recovery, he needs to publish the results using a comprehensive and conservative definition of recovery. Better late than never. The same could be said for actigraphy, which could be collected in the 5 year followup that is due in about a year or so.

Bristol is also a good distance from London so reasonable amount of time spent going and coming back.

 

[WillowJ]

What about stuff you think you know but is wrong?

Isn't that included in stuff you don't know you don't know?

 

[Dolphin]

Someone has posted photos of slides

https://www.dropbox.com/sc/h6c4d3l7zmuwunl/iB2mvmlDCn#/

Link no longer works

 

[Esther12]

I've tried to put them up. If this is a problem, let me know. Also - I'm posting thumbnails, as I didn't want to blow any forum software - but I could change.

 

[Esther12]

 

[Esther12]

 

[Esther12]

 

[Esther12]

 

[Dolphin]

One person who was the meeting said I could post this:

" The appraisal method highlighted significant methodological and quality issues which must be addressed in future research. "
Quite clearly waving my £6.50 pedometer at Prof White at his recent seminar in Bristol, which Esther Crawley chaired, and asking 'Why, oh why, didn't you use these to measure activity changes in the PACE trial' has had an effect already!! They appear, at last, to be beginning to accept how 'dodgy' those dire questionnaires are for gathering reliable scientific data.
Prof White replied to my question at the seminar saying that they did use pedometers but were told they had to cut back and people didn't like being tagged on the ankle every day with them.

 

[Dolphin]

Someone has posted photos of slides

https://www.dropbox.com/sc/h6c4d3l7zmuwunl/iB2mvmlDCn#/

The link to use now is: https://www.dropbox.com/sc/6a9m7wgz2soewah/APe2fH_ATM