Discussion in 'Latest ME/CFS Research' started by anniekim, Feb 24, 2011.
And to demonstrate that, here is Malcolm Hooper's response to David Jameson on this issue:
Another little gem from the PACE article (page 13)
Now they've already told us (page 2) that:
So, all those patients (more than 2300), who had to be excluded from the research because they didn't have Oxford defined Chronic Fatigue Syndrome, came from the Chronic Fatigue Syndrome clinics!!!!!
To further discuss the facilitation of exclusion of actual ME sufferers from the PACE trial:
Information from the MS society about symptoms that present in MS. Note how they acknowledge these aren't unique to MS- but are serious enough to indicate a severe neurological condition:
Now let's look at some of the symptoms (which may also engender clinical neurological signs) in ME, as described by Ramsay (this is from page 417 of the pdf 'Magical Medicine':
Then we can look at Canadian defined ME/CFS, summarised here:
Forgetting the Editors caveats with the CC (which I agree with) - the issue here is what are ME sufferers (even if they are given a CFS diagnosis) presenting with? Unless my daughter is very rare, and I've been engaging with the completely wrong community for many years, MOST of you will have a constellation of symptoms (and, if looked for, signs) of the above neurological manifestations, even if some of you did not realise these were neurological in origin, and many of them overlap with presentations of MS.
Now, over 2300 people SENT TO ONE OF SIX CHRONIC FATIGUE CLINICS BY THEIR GPS were deemed unsuitable for the trial because they allegedly did NOT have 'chronic fatigue syndrome'- whatever that means! Whatever happened to them (likely many sent back to the chronic fatigue clinic for non researched cbt/get and some psychogenic dismissal of their symptoms and signs), while they were being considered for selection into the cohort, by the rubric of Oxford and Fukuda, Reeves and NICE (but let's focus Oxford as that very specific first application of exclusion), a person turning up with the neurological manifestations (as signs and/or symptoms) might be at risk of having, let's argue, just for the moment, not even ME, but Multiple Sclerosis. The last thing White, Wessely, Sharpe etc. want is MS sufferers in their cohorts, and they would actually be required to select these out.
Because ME has been so downplayed, so trivialised and the sufferers demonised, it's often very hard for people, even sufferers themselves, to understand how neurological the condition is. It is this very neurological presentation that allows them to be selected out of RESEARCH cohorts, even while their neurological and other impairments are, in clinical practice, downplayed and overlooked by their GPs and at the 'chronic fatigue' clinics, and subject to psychogenic explanations and dismissal.
I also think it has been very hard for people (and I include myself here) to get their heads around the fact that they could be actively excluded from the psych research. The psychs do appear to have heterogenous cohorts (looking at the Webappendix serious adverse events record demonstrates that, for example) - so all sorts of people might be herded into the fatigue clinics, for example. BUT - despite this heterogeneity, the mechanisms for active exclusion of neurological ME sufferers for RESEARCH are there in Oxford, Fukuda, NICE, Reeves 2003 and 2005 etc. so that the one group who really SHOULD be the key components of the research cohorts, can be neatly excluded.
Hi Angela, this inference is not valid. It could be true, but it could also be false. At the other extreme, it is also possible they only accepted patients from chronic fatigue syndrome clinics as having real CFS. In between, it could be that they had, for example, 2000 patients who were not from chronic fatigue syndrome clinics and so were rejected.
I suspect you are correct Angela, but this conclusion requires more evidence than you cite.
Hi Angela, with respect to post 23, I worry even more that only quite healthy and mobile CFS patients are treated and researched, as large numbers of us could not even get to clinics for treatment. How many studies are they going to keep doing on the moderately and barely sick? When are they going to start studying housebound patients? What about bedbound patients? How are severe bedbound patients going to even listen to a CBT therapist, or remember any of it? How can a severe bedbound patient do more than twitch their fingers for exercise? Its a travesty to claim the things the biopsychosocial "researchers" claim. Bye, Alex
Alex, firstly, what's real CFS?
Secondly, The PACE article itself says (page 2):
All patients screened and assessed were from the above.
But actually, you are right about the 2300 figure not being a total reflecting people 'not having chronic fatigue syndrome'. Looking at the article demonstrates that.
From the CONSORT trial profile (page 4 of the pdf), out of 3158 screened and 'assessed' for eligibility, if my calculations are correct, 2517 people were excluded, at two levels.
Now the PACE authors at this stage say NOTHING about EXCLUSION criteria, funnily enough. They don't give figures for exclusions. But:
1011 had 'no' current Oxford diagnosis of CFS at 'screening', while 67 did not meet Oxford diagnosis of CFS at 'assessment'
That's an awful lot of people being farmed off to a chronic fatigue unit by their GPs, who are not actually eligible for the chronic fatigue/chronic fatigue syndrome criteria!
That's even before we look at some of the other vague reasons for exclusion:
"unable to comply with protocol" (139 at 'screening', 52 at 'assessment')
"contraindication to treatment" (71 at 'screening', 13 at 'assessment')
I think the fact that exclusion figures (whether using Oxford, Reeves 2003, or NICE) are not quantified is significant, and that it is reasonable of to infer that this is related to the objections people made about Oxford criteria throughout the trial, and to the evidence available demonstrating that they could (and I believe did) exclude 'neurological' ME sufferers from the research cohort.
Yes, I agree totally Alex. This is another important issue that people will have to push as an objection to the claims of the PACE authors.
From other threads, some further comments of relevance:
Tom Kindlon has posted some very interesting information on Co-cure about the PACE trial's apparent use of -mm- Reeves? Fukuda? Having seen that case report form, this throws up some more questions (of course!):
The second post from Tom:
I'm not convinced of that. For one thing, White is one of the authors of the 2003 paper so I think he wouldn't get the two mixed up.
Ah, just like how they "didn't mix up" the normative data for a working age population despite showing familiarity with the figures? ;-)
Thanks Dolphin for mentioning this on this thread. I had forgot to put my recent findings about this issue (which we've discussed on the other thread) here.
They DID use Reeves et al 2003. Reeves et al 2003 are even more exclusionary than Fukuda (and more resembling Oxford!) in that any clinical SIGN associated with Fukuda symptoms (for example, actual swelling or redness of joints, inflamed throat and tonsils, palpable lymph nodes!) are to be in effect EXCLUSIONARY for CFS. Reeves et al actually say 'alternative diagnoses should be sought' for these signs!
In a research setting, this means such patients will be excluded from research where Reeves et al, 2003, are the selection criteria.
Taking these, the NICE exclusions and the first line Oxford exclusion, into account demonstrates that there was a determined effort to try and ensure no patients with physical signs were included in the PACE trial. Indeed, to deny this would contradict their own methodology, both in the PACE trial and in other projects!
That's possible, but 'alternative diagnoses should be sought' presumably means just that; such signs are not listed under the exclusionary criteria, though presumably would lead to exclusion if an alternative diagnosis was found - but not if no such diagnosis was made. It would be very helpful, though, to know how many prospective PACE particpants had signs rather than symptoms.
But this was an 'identification of ambiguities' in Fukuda: the whole article was an attempt to make less ambiguous FOR RESEARCH, NOT CLINICAL PURPOSES.
Now, you could argue that they didn't do a very good job of this, because you have read into it what you have- but I need to make clear, that was not what they've argued (that if alternative diagnoses are not found for clinical signs, that means the patients has CFS).
The point is, the mechanism is there to exclude patients with clinical SIGNS. Indeed, this mechanism is consistent with CFS as a diagnosis of exclusion, and Wessely and others focus on patients allegedly only having 'symptoms', not 'signs' (which is highly unsafe as a claim- but is nevertheless made).
I really cannot see the notes being released publicly to see how many of the PACE cohort (or those excluded) had signs! Can anyone?
Well, to be serious, I don't think Peter White would have criticiued the Reeves et al. 2005 criteria as a peer reviewer in late 2006 (here: http://www.biomedcentral.com/imedia/1083914155124266_comment.pdf ) if they had used it.
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