Reply to thread post range 601-630
ancientdaze, I think you may be making some good points, but I'm afraid I lack the experience to fully comprehend them and put them to practical use on the PACE trial.
Some good points there. Again, I agree the phrasing of CBT and GET vs APT is a significant enough problem for the PACE trial, since being a psychological study using subjective questionnaires and aimed at changing patients' perceptions and beliefs.
If PACE really wanted to adequately test the "pathological model of ME" (as they claim they do in the APT arm), they shouldn't have used such a highly selective process that went to great lengths to exclude anyone with potential pathology or symptoms from the CCC which White simply doesn't like. 80% of candidates were excluded from the trial (admittedly, some of those refused). What they were really testing was the psychological effects of the "pathological model of ME" on people they believe have "abnormal illness beliefs", certainly not a CCC-like "pathological model of ME". White et al have never agreed with pacing, and APT itself was a classic strawman argument used to discredit a position that the ME/CFS community doesn't hold.
Marco wrote: Equating 'normal' functioning as being that of a 65+ year old is a fairly damning thing to highlight.
Indeed. On average the CBT and GET groups scored about the same as the 75-84yrs age group in Bowling et al. How they defined and calculated "normal" physical functioning was one of the more severe and obvious blunders made by the authors. Except a blunder is defined as "an embarrassing mistake" and this was not a mistake and the authors aren't going to be embarrassed when they are receiving funding and praise. For anyone willing to look beneath the gloss as we have been doing, it's bad enough to cast doubt on them as researchers, and no one except the ME/CFS community has noticed or cared.
What this shows us is that it's OK in mainstream academia to publish inappropriate definitions of "normal" which are clearly abnormal. As far as I am concerned, the reputation of the Lancet is in question over letting that through, along with the editorial confusing the original protocol's definitions of "positive outcome" and "recovery" with the relaxed definitions of "improvements" and "normal". And that's what happens when the Lancet doesn't bother to peer-review its editorials, factual errors escape through into print for the world to read.
oceanblue wrote:
Apparently comment pieces are not normally peer reviewed. I think B&K made a genuine mistake, which goes to show how deceptive PACE were.
In fact, Knoop did a study on recovery which appears to be the origin of the 'within 1 SD of the mean' formula. However, this study explicitly applied the forumla to a healthy population defined as general pop excluding those who reported a long-term health issue. This gave a reasonable SF36 threshold of 80. B&K assumed PACE did the same thing, but PACE just used a general population, including the sick, giving a threshold of 60. Sneaky, eh?
In case you think it was a simple 'mistake' by PACE to use the wrong population, it wasn't: Peter White co-authored that Knoop study which had explicity used a healthy population.
[Dolphin on Bleijenberg & Knoop's work using PF/SF-36, and "I don't think they can be given the benefit of the doubt here."]
So it seems that the only plausible explanations are: B&K didn't even bother to read the PACE Lancet paper close enough to notice PACE pulling the old switcheroo, or, basically they lied. That's pretty damning either way. It encourages me to distrust them, and the Lancet.
oceanblue wrote:
Problem with self-reports acknowledged in a CBT study on MS
"An additional limitation was that outcome assessment in this study depended on self-rated outcome measures. No objective measures exist for subjectively experienced fatigue, so we chose reproducible measures that are sensitive to change. However, self-reports are amenable to response bias and social desirability effects. Future studies could also assess more objective measures of change such as increases in activity levels and sleep/wake patterns using actigraphs or mental fatigue using reaction time tasks."
How refreshingly honest.
from A Randomized Controlled Trial of Cognitive Behavior Therapy for Multiple Sclerosis Fatigue
http://www.psychosomaticmedicine.org/cgi/content/abstract/70/2/205
I think they are forced to be more "honest" in established diseases. CFS is more of a free for all. Anything that is "subjective" is more susceptible to spin and post-modernist interpretations.
Angela Kennedy wrote:
Problem is, devil is the detail (or lack of thereof).
If we take as given (as i think we should, at least when considering this issue - think even of Peter White's dept denying that bowel problems are part of 'CFS/ME' in the NICE guidelines comments, for example), then these authors are ignoring neurological ME-related problems (they don't believe in the ME with neurological features, Canadian defined ME etc.).
Caveat about the efficient process of exclusion of neurological ME patients not withstanding, IF ANY actual ME (or other misdiagnosed 'fatigue') patients were in the mix, increase in disability might well be a result of 'treatment' upon abnormal response to increasing exertion etc.
This is fact goes to the crux of the matter. They are blanket-claiming CBT/GET as safe for people with (even neurological) ME, against the evidence it is contraindicated (which they don't adequately address, of course).
Adverse outcome details should have been made explicit, and just writing vague descriptions like these, and then saying something like "independent investigators thought they were nothing to do with our treatment" which is basically what they've done, is really not good enough, and should have been picked up at peer review.
My impression was that the GET group had a "safety net" from severe exacerbations because they were very cautious and while participants were encouraged to increase activity on a regular basis
if possible they were not forced to do so, so it was possible to remain in the GET group at 52 weeks without any actual increases in activity whatsoever since we are not told how many patients managed to increase their activity levels overall. As you and others have implied, the data on adverse effects has also been obscured and may be worth investigating in more detail.
Thanks, that will be useful.
Thanks for that.
oceanblue wrote: "So the net effect of CBT or GET, after 1 year, was to move particpants from around the bottom 13% of SF-36 scores to around the bottom 15%." Dolphin responded: "Excellent way of putting it. (And that's giving them
58 as the 15th percentile of the adult population - I'd say it could be a bit lower based on figures I've seen)."
That sounds about right, 58 or 60/100 points was roughly the 15th percentile for the general population in Bowling et al, which includes the diseased and elderly. Wouldn't be surprised if it is more like 5% percentile for a healthy age-matched control group. And because of the skewed distribution we have the odd situation where roughly 75% of the population are scoring above the average! 60 may be the 15th percentile but 85 is still only (roughly) the 25th percentile, a figure White et al used to help define a full recovery but omitted from the PACE trial results.