"Why ME patients are critical of the PACE trial" (from ME Action network)
http://www.meaction.net/wp-content/...atient-view-of-the-PACE-Trial-Controversy.pdf
http://www.meaction.net/wp-content/...atient-view-of-the-PACE-Trial-Controversy.pdf
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"Why ME patients are critical of the PACE trial" (from ME Action network)
- Thread starter Dolphin
- Start date
On Sunday November 30 they posted this on Twitter:
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Also this on Facebook:
https://www.facebook.com/MEActNet/posts/1671369023145497
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Also this on Facebook:
https://www.facebook.com/MEActNet/posts/1671369023145497
Initially I couldn't think what "the failure to report objective measures included in the original trial design in favor of reporting subjective outcome measures" could refer to but the initial plan involved using actometers to see how much activity were doing but this was dropped.
It seems quite likely that when it was approved for funding by the MRC and other bodies actometers were planned as they seems to have been dropped when an ethics committee said they had a lot of outcome measures which in total might be a burden for participants (I think more questionnaires were added by the investigators at around this stage). As I understand it, the ethics committee didn't tell them to drop actometers specifically. Also I recall somebody in the know telling me at the end of 2003 or early 2004 that it contained actometers. This was after MRC approval.
It seems quite likely that when it was approved for funding by the MRC and other bodies actometers were planned as they seems to have been dropped when an ethics committee said they had a lot of outcome measures which in total might be a burden for participants (I think more questionnaires were added by the investigators at around this stage). As I understand it, the ethics committee didn't tell them to drop actometers specifically. Also I recall somebody in the know telling me at the end of 2003 or early 2004 that it contained actometers. This was after MRC approval.
Fitness test results were not reported in the main PACE paper (Feb 2011). No unfavourable objective results were reported in that paper. The only objective result reported was the 6MWD test, which was technically 'positive', but only barely, only for one arm (GET), and only for mild-moderately affected patients, with even those patients still being left scoring around the same level as some of the sickest patients medicine has to deal with. Hardly a roaring real-world success. Not to mention that the PACE authors themselves have downplayed the reliability of their own 6MWD results.
All the other objective results were unfavourable (null), and were buried in subsequent secondary papers, and misrepresented/spun/ignored, etc, when they were reported.
Then there is the 2.5 year follow-up results. Null in every direction. (Which, of course, kills off any claim in all previous PACE papers about any practically useful outcomes. For example, the mediation results are now meaningless.)
It is difficult to convey just how bad this all is to people not familiar with either PACE or science in general. Most can't believe the scale and implications of it, and so default to the explanation that patients must be exaggerating/hysterical/conspiratorial/mentally ill/in denial/vexatious cyber-terrorists/malingering parasites, etc. Which views the PACE crowd do their very best to encourage.
Even this life-long cynic, well past the age when I can plead youthful naivety, still has trouble wrapping my head around just how blatant, sustained, and destructive it is, and how the hell they have got away with it for as long as they have.
All the other objective results were unfavourable (null), and were buried in subsequent secondary papers, and misrepresented/spun/ignored, etc, when they were reported.
Then there is the 2.5 year follow-up results. Null in every direction. (Which, of course, kills off any claim in all previous PACE papers about any practically useful outcomes. For example, the mediation results are now meaningless.)
It is difficult to convey just how bad this all is to people not familiar with either PACE or science in general. Most can't believe the scale and implications of it, and so default to the explanation that patients must be exaggerating/hysterical/conspiratorial/mentally ill/in denial/vexatious cyber-terrorists/malingering parasites, etc. Which views the PACE crowd do their very best to encourage.
Even this life-long cynic, well past the age when I can plead youthful naivety, still has trouble wrapping my head around just how blatant, sustained, and destructive it is, and how the hell they have got away with it for as long as they have.
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Bob
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anciendaze
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I've puzzled over the structure of the PACE protocol, and revisions to same, from a point early in this controversy. Why were all objective measures secondary to questionnaires seeking subjective data? Why were some, but not all, objective measures simply dropped? Why were those which survived implemented in defective ways, causing the authors themselves to declare that they didn't mean much, as was true of the 6-minute walk? Why were participants allowed to skip objective measures if they didn't feel like making the effort?
I think the idea was merely to get the label of "objective randomized controlled trial". (The "control" group was actually receiving standard NHS therapy, which may not have had any significant value, but it wouldn't do to study anything which brought current practice into question.) The value of that data was reduced to the point of meaninglessness, but the label remained.
Given the way these authors have played with words and numbers to indicate this study might actually have had some therapeutic value, I recommend they add another label to the list of authors: "may contain nuts".
I think the idea was merely to get the label of "objective randomized controlled trial". (The "control" group was actually receiving standard NHS therapy, which may not have had any significant value, but it wouldn't do to study anything which brought current practice into question.) The value of that data was reduced to the point of meaninglessness, but the label remained.
Given the way these authors have played with words and numbers to indicate this study might actually have had some therapeutic value, I recommend they add another label to the list of authors: "may contain nuts".
Original protocol also included a "Step test" (https://en.m.wikipedia.org/wiki/Harvard_step_test), which I believe is where the "fitness" data came from (the tiny graph that showed worst outcomes from GET)
lansbergen
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