PACE Trial and PACE Trial Protocol

[Dolphin]

"Permanent" link to the full (unpublished) PACE protocol

"Permanent" link to the full (unpublished) PACE protocol: http://www.meactionuk.org.uk/FULL-Protocol-SEARCHABLE-version.pdf
(IIRC, previously links were given that only worked for a short period).

I'll add in the figures no for the no improvement on either the SF-36 PF or CFQ now.

 

[Valentijn]

Thanks for the link, Dolphin! Something I find interesting is in the Adverse Events section (pages 65-66). Aside from being dead or in immediate danger of dying, the only other severe adverse event (SAE) requires 4 weeks of being incapacitated. This seems rather ridiculous, considering that specific crashes rarely last more than a couple weeks, and are likely to be recurring as soon as exercise is attempted again, making them a serious side-effect for people chronically disabled by them.

And the example for the related non-serious adverse event (the only alternative to having a SAE) is "Transient exacerbation of fatigue or pain ...which does not have significant impact upon function." Followed by a footnote that seems to be referring to "death" as a significant impact upon function

If I understand what I've read on here, not much data has been released regarding adverse events (or the details of the study in general). When/if it does come out, I bet it's going to 1) put everything that didn't cross the threshold for a SAE into the non-serious category, and 2) strongly imply that all non-serious adverse events are equivalent to having no significant impact on function.

Basically I think they included that "insignificant" example for that exact reason. The other non-serious adverse events are still significant (new mood/sleep/anxiety disorders or injury), but making the threshold for PEM insignificant means that there is no specific acknowledgment of the PEM crash. Either participants had PEM for a month, or their PEM will be put into the same category with "does not have a significant impact on fuction." I'd be very surprised if they make any distinction between "I felt a bit tired and sore after that walk" and "I was bedbound for 3.5 weeks."

 

[WillowJ]

The Wessely study from 1997 found a prevalence of 11.6% for Chronic Fatigue against only 2.2% for Oxford Criteria so it probably isn't safe to use Chronic Fatigue as a proxy for Oxford Criteria CFS. I think there are some studies around suggesting that the prognosis for CF is much better than for CFS (but don't ask me for references!) so the Nijrolder results might not be so surprising.

it looks like the reference may not be needed, but according to the CCC (I think they say that; I know one of the CFS orgs used to say this but I can't find that page any more; I think the site was edited), Joyce et. al says this (I don't have the full text of that to read it myself). SW is an author.

 

[Dolphin]

The Wessely study from 1997 found a prevalence of 11.6% for Chronic Fatigue against only 2.2% for Oxford Criteria so it probably isn't safe to use Chronic Fatigue as a proxy for Oxford Criteria CFS. I think there are some studies around suggesting that the prognosis for CF is much better than for CFS (but don't ask me for references!) so the Nijrolder results might not be so surprising.

it looks like the reference may not be needed, but according to the CCC (I think they say that; I know one of the CFS orgs used to say this but I can't find that page any more; I think the site was edited), Joyce et. al says this (I don't have the full text of that to read it myself). SW is an author.

In case anyone wants to know: the PubMed link says the Joyce et al paper is free at: http://jama.ama-assn.org/content/280/3/264.long

 

[WillowJ]

In case anyone wants to know: the PubMed link says the Joyce et al paper is free at: http://jama.ama-assn.org/content/280/3/264.long

there I go not reading the fine print again. silly me.

 

[WillowJ]

evidently my mind is not on what I'm doing today... the correct Joyce and Wessely article is this one; it's also supposed to be free full text

 

[Graham]

I find it reassuring when that happens to other people too! I couldn't get the link to the free full text to work though. I did find a pdf download via Google though.

 

[WillowJ]

I find it reassuring when that happens to other people too! I couldn't get the link to the free full text to work though. I did find a pdf download via Google though.

I couldn't get it to work, either. Brought up Journal of Bacteriology... a happy place for me--a [wannabe] cell biologist--to find myself! :Retro smile: but not exactly QJM or Oxford Journals home page.
Thanks for doing the work to find the full text. I'm slacking just now. :innocent1:

 

[WillowJ]

I find it reassuring when that happens to other people too! I couldn't get the link to the free full text to work though. I did find a pdf download via Google though.

When I looked at your link, it was the Cairns and Hotopf 2005 update to Joyce et al., which (the update) is cumbered by reports of improvement via CBT/GET.
The Joyce, Hotopf, and Wessely 1997 paper can be found here, if needed.
having looked at them, I now remember reading them both before...

 

[oceanblue]

Peter White agrees with Dolphin

Sorry, I'm getting a taste for histrionic titles. Anyway, somwhere in the unnavigable depths of this thread, Dolphin made an elegant point. He noted that since, by definition, people with most chronic illness, such as cancer, diabetes and heart problems, are excluded from CFS studies they should also be excluded from the reference 'normal' population group.

Of course, PACE didn't do this, and even included the old as well as the chronically sick in it's 'normal' populaton group. However, a recent paper co-authored by Peter White takes just this approach of excluding from the comparison group those excluded from CFS groups:

Psychopathology and Physical Activity as Predictors of Chronic Fatigue Syndrome in the 1958 British Birth Cohort: A Replication Study of the 1946 and 1970 Birth Cohorts
...
Healthy Comparison Group
A representative healthy comparison group (N = 9259) was derived, which excluded anyself reported cases of CFS/ME, and other functional syndromes or CFS/ME medical exclusions (e.g., irritable bowel syndrome, inflammatory bowel disease). Participants who were likely to meet the other CDC exclusion criteria for CFS/ME (13) were also excluded, including: self reported anorexia/bulimia at 42 years, alcohol misuse (14), substance abuse, and body mass index (BMI) greater than 40. This comparison group was used as a reference category to the CFS/ME group in all of the logistic regression analyses.

Of course, taking this approach maximises the difference between patients and the reference group, which presumably suits the authors interests here, while in the PACE trial minising differences between patients and population groups made the Trial look more successful.

I thought this new study might be useful to cite when it comes to the long-awaited PACE 'recovery' paper, which will no doubt find new and creative ways of defining the population comparison group.

 

[Graham]

I think he is missing a trick here. If he defined the target scores for CFS/ME patients to be purely the scores for people with severe but treatable illnesses, he could then claim that once he had got people with ME up to that level, the GP could take over and finish the cure.

Do you think I have a future in helping people to design effective studies?

 

[Dolphin]

I just came across the following:

(from http://www.anh-europe.org/news/edzard-ernst-on-the-self-promotion-trail )

Seems like it might be a good model for what happened in the PACE Trial

 

[Esther12]

When I saw this thread bumped I did get a fear that the PACE results were being re-spun to take advantage of the XMRV publicity. Phew.

 

[Guido den Broeder]

Einstein taught us that the observer and the observation cannot be separated. Then again, CERN have just broken Einstein's formula...

 

[anciendaze]

Einstein taught us that the observer and the observation cannot be separated. Then again, CERN have just broken Einstein's formula...

Believe you are talking about Heisenberg. Einstein never accepted the Copenhagen interpretation as fundamental. (Check the EPR paper.) As for the CERN to Gran Sasso speed record, we are talking about a discrepancy of about 20 meters over a distance of 732 km., or an error of 60 nanoseconds. When you work to this precision you have to consider many things commonly ignored, like Earth tides which actually change the distance. One of the things which occurred to me is that we don't actually know the refractive index of rock for neutrinos.

I'd be happy to see this confirmed, because we need new fundamental physics to clear up several problems. Loop quantum gravity actually predicts that the speed of light is not the same for all photons. High energy photons are expected to travel a tiny bit faster than low energy ones.

 

[Bob]

Well, a light-hearted bit of quantum physics feels quite refreshing after the complexities of the PACE Trial!

 

[Bob]

When I saw this thread bumped I did get a fear that the PACE results were being re-spun to take advantage of the XMRV publicity. Phew.

I know what you mean Esther! l've been bracing myself to see bad news everywhere at the moment!

 

[Graham]

Believe you are talking about Heisenberg.

I'm a bit uncertain about that, anciendaze. I never really knew where Heisenberg was coming from, and he was always too fast for me.

 

[Guido den Broeder]

The Copenhagen principle deals with the concept of full information.

While with Einstein the laws of physics are the same for all observers, the observations are not. For instance, if I travel through space at high velocity and return to Earth, less time passes for me than for those who remain.

In the PACE trial, the bars kept being moved during the study. Therefore, the researchers observed something different than they would have seen in an inertial frame of reference.

(As for CERN, the actual distance travelled by the particles may have been shorter than the length of the straight line.)

 

[Graham]

Guido - you've solved it! The authors of the PACE trial are neutrinos, only minimally interacting with normal matter (like us), and for whom their time frame is so short the almost flat progress line on those fatigue and physical function graphs compresses into a near vertical drop of amazing change.

There's only one problem with this interpretation though - from what I understand of neutrinos, there shouldn't be much to keep them here on Earth, and they should have left us a long time ago. Why then do they keep popping up and giving interviews? Is that just resonance?