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PACE study and oxford criteria

Discussion in 'Latest ME/CFS Research' started by anniekim, Feb 24, 2011.

  1. anniekim

    anniekim Senior Member

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    A poster wrote the following about the Oxford criteria and the Pace trial, 'They selected first using the Oxford Definition but ME patients are actively excluded at that point as they often have neurological signs so they cannot be selected afterwards'.

    Sorry have I been misunderstanding this? I thought the Oxford Criteria meant that neurological symptoms, pem etc.are not required to get a diagnosis of CFS, just fatigue (which could be due to depression, anxiety, burn out and so on these are not exclusions in the Oxford criteria), but neurological symptoms and PEM alongside fatigue does not mean you are excluded from a diagnosis of CFS (in UK often interchanged wih M.E) under the Oxford criteria?

    Would really appreciate an answer to this as the assertion that people with the classic symptoms of M.E/CFS such as neurological and post exertional malaise would be excluded from a diagnosis under the Oxford criteria - and if true would not be even studied under the Pace trial - has really confused and thrown me. Many thanks in advance.
  2. Angela Kennedy

    Angela Kennedy *****

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    Well - the Oxford Criteria are an exercise in semantics and linguistic and conceptual gymnastics, a common problem with CFS criteria. The devil is in the detail - but the important thing to remember is that Oxford ALLOWS EXCLUSION of signs and symptoms of organic disease in order to select sufferers OUT of RESEARCH cohorts.

    Around the time these were published, Anthony David, referring to these, commented:

    Here special attention needs to be paid to the term ‘previous viral infections’ and ‘absence of neurological signs’, in order to contextualise the cohort selection process applied using the Oxford Criteria.

    CFS (and I would argue, some ME, including the London) criteria allow a Humpty Dumpty approach (from Through the Looking Glass):

  3. oceanblue

    oceanblue Senior Member

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    You can find the exclusions for the Oxford Criteria used by PACE here
    http://forums.aboutmecfs.org/showth...l-and-PACE-Trial-Protocol&p=154121#post154121. There's nothing that i can see that would actively exclude ME patients so I'm confused too.
  4. Angela Kennedy

    Angela Kennedy *****

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    I can't find that post with those OXFORD exclusions Oceanblue- any chance you could cut and paste for me please?

    The cohort used for the negative XMRV study (Erlwein et al) and Wessely and Cleare's further descriptions do shed some more light on the matter. Here is my response to them (I looked at the references they gave in their PlosOne post):


    http://www.plosone.org/annotation/l...notation/13ea20d1-91e6-49c3-bc4b-8fd1ca18f150


  5. oceanblue

    oceanblue Senior Member

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    Here's the key part from that post:

    Don't suppose you could summarise the key points in the post you just made? I don't have the energy to read it all. thanks
  6. Angela Kennedy

    Angela Kennedy *****

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    But that paragraph show this is about Fukuda, not Oxford.

    I'll bold key points - they may still be long though!
  7. Angela Kennedy

    Angela Kennedy *****

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    Bolded most (I hope) relevant points:

  8. oceanblue

    oceanblue Senior Member

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    Yes, the PACE trial used the Fukuda exclusions for the Oxford Criteria.
  9. oceanblue

    oceanblue Senior Member

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    I still don't see how, in practice, any ME patients are excluded by the PACE definition. Which tests of organic abnormality do you think they are using to exclude patients?
  10. Angela Kennedy

    Angela Kennedy *****

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    Can you clarify what you mean by that, oceanblue?
  11. Angela Kennedy

    Angela Kennedy *****

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    The key is that any reporting of symptoms that might show neurological damage (say, for example, blurred vision, POTS, as just two examples) or even certain neurological signs that a GP can test in their surgery would allow exclusion under Oxford (and Fukuda, for that matter). These are present in ME patients, as Ramsay's definition, Canadian criteria demonstrate.
  12. oceanblue

    oceanblue Senior Member

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    1. Those exclusion say "major neurologic diseases (e.g., multiple sclerosis, neuromuscular diseases, epilepsy or other diseases requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)", which doesn't really include blurred vision or POTS. In fact, a friend of mine is a patient at Bart's and her POTs didn't get in the way of a CFS diagnosis.
    2. Could you say which neurological tests done by GPs exclude ME?

    So far at least, I can't see how this excludes all or even many ME patients from the PACE version of the Oxford Criteria.
  13. Angela Kennedy

    Angela Kennedy *****

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    1.Can you cite where that quote's come from Oceanblue? Secondly, ME is a neurological disease! It is accepted as such by the World Health Organisation (since 1969). People with ME (not chronic fatigue) have signs and symptoms of neurological dysfunction, as demonstrated in, as I've already said, Ramsay and the CC. By the rubric of the Oxford criteria (even though these are often quoted in diverse terms) they should be (and can be- the conceptual mechanism is there) excluded from a RESEARCH cohort.

    Also -you do understand that neurologic deficits INCLUDE blurred vision and POTS?

    ALso- the devil is in the detail - 'other diseases' means an ME sufferer can be excluded from a RESEARCH cohort.

    It's very interesting- your anecdote about your friend. When the negative XMRV study came out- Wessely and Cleare brought something to my attention (they didn't intend to). They select their RESEARCH cohorts FROM clinic attendees. This is done ad hoc, because SOME people attending the clinics WILL HAVE 'neurological deficits' (for example POTS). But the psychs do not admit 'consecutive' clinic attendees to their RESEARCH cohorts (This is a vital piece of information). They only admit people for whom they've EXCLUDED evidence of organic disease! So some (probably most) clinic attendees are left out of the research because they have evidence of organic disease.

    In this way, CLINICAL attendees can still be (sometimes extremely) ill with signs and symptoms of neurological dysfunction (such as POTS) but still get a 'CFS' diagnosis, told it's medically unexplained (with the minimum of investigations I might add), be subjected to psychogenic dismissal and only offered CBT/GET by the clinics.

    2. Romberg's sign, Babinski's sign, nystagmus are just 3 of a battery of signs that can be elucidated by a GP. These can be found in ME sufferers, as can other neurological deficits at both sign and symptom levels of detection.

    I'm sorry that you cannot see how these criteria have the capacity to be used to exclude ME patients from the Oxford Criteria. It's actually there in my answer to Wessely and Cleare (and indeed in their response that led me to make my response).

    As for the 'PACE version of the Oxford Criteria'. You need to clarify what you mean there. I can actually quote the text from the PACE article here (all from page 2, my bolding):

    Obviously this supports the point about patients not being SELECTED for research cohorts just by being a patient.

    Ok, Oxford is the first line selction (and exclusion) criteria for this research cohort. Interestingly, the 2003 Reeves et al article is given as reference here (as is NICE). But 2003 isn’t the criteria as such- but an article arguing identification of ambiguities in Fukuda! The actual criteria article was produced in 2005:

    So they weren’t necessarily using Fukuda at all!!! This needs further investigation.

    They go on:

    Well - ME sufferers (particularly the seriously affected) have those (those with cardiovascular and mitochondrial failure, for example?). So this provides yet another means of excluding ME sufferers from the research cohort (just in case any slipped through the net- which I accept is possible, although the chances of this happening have been deliberately lessened, from the evidence available).

    Again, the 2003 Reeves paper is given (I suspect incorrectly) here - NOT Fukuda! Note the interesting use of 'version 2 of the London criteria'. So we know there IS more than one version of the so-called 'London' criteria doing the rounds on the internet! As far as I know- only one version was given in the National Task Force report?

    So to summarise- Oxford, Reeves, Fukuda, NICE etc. allow EXCLUSION of ME sufferers for RESEARCH purposes, even if those sufferers are called 'CFS' as CLINICAL attendees (whether at special clinic or GP). It relates to the fallacious concept of 'medically unexplained' where people are not given the investigations they need by GPs or the clinics, UNLESS it's to exclude organic illness (of which ME is one- not because I want it to be, but because of the clinical descriptions such as Ramsay, Carruthers et al, even Nightingale, that show that). PACE have been tinkering with ad hoc methodology I suspect, and we should be scrutinising this very closely (not just outcome measures- though these are very useful).

    Christine Hunter of the Alison Hunter Foundation had something very interesting to say today which I think also sums up my point earlier:

  14. Angela Kennedy

    Angela Kennedy *****

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    From my PloSone letter, just to reiterate my point about the issue of CLINICAL attendees versus RESEARCH cohorts and how they are treated differently:

  15. alex3619

    alex3619 Senior Member

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    I think this is a very unclear issue, the use of neurological symptoms to exclude a CFS diagnosis under the Oxford criteria. It would not surprise me if the general lack of knowledge of the fine details mean some patients are excluded, and some are not, with the same symptoms. It would also not surprise me if this were used as an exploit by some researchers. Bye, Alex
  16. Angela Kennedy

    Angela Kennedy *****

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    Well what was interesting on the PloSone responses were patients who were saying (to paraphrase) "we've attended the clinics and get no suitable investigations like the ones Wessely et al claim their cohort had". This pointed to there being a complete difference in the way RESEARCH and CLINICAL cohorts are treated.

    Oxford is NOT used in CLINICAL diagnosis as such - so investigations are limited for patients NOT in a research cohort. You'll find plenty of CLINICAL patients at the clinic with neurological symptoms and signs. But NOT in the RESEARCH cohorts. They can't be, by the very rubric of the researcher's tools themselves.

    I used to believe the researchers were letting in neurological deficit sufferers into their research cohorts because I couldn't get my head around what was happening. It wasn't until the negative XMRV study, ironically, and us all calling for CC to be used like in Lombardi et al, and then this belligerent attempt by Wessely and Cleare to bully people into guilty submission ('how dare you say these patients aren't suffering' sort of accusation) that they unwittingly gave information that showed what they do with research cohorts that they dont' do to clinical patients (investigations to exclude things) AND EXCLUDE people from the research cohorts with evidence of organic disease (which neurological symptoms would not do- let alone signs).

    Now 'neuros' may still get under the net- but the chances of that are very slim. With PACE- they were required to find new patients for RESEARCH and we know there were problems in achieving that. What that means in terms of cohort is uncertain- but we should be aware that the vast majority of people in the trial may not have had any neuro signs and symptoms associated with the ME criteria such as Ramsay and Carruthers et al (the cc).

    Understanding that does not mean that CBT/GET is 'efficacious and safe' even for 'fatigue' sufferers. We don't know exactly the various types of patient in the PACE trial really. But it is highly unlikely that there were sufficient numbers of actual neuro symptoms/signs 'ME' sufferers to make any assertion about efficacy and safety for actual ME or related neurological illness sufferers (Lyme). It means there are further major confounders in this trial to make the results unsafe.
  17. Angela Kennedy

    Angela Kennedy *****

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    The other thing I would say is this is a very important issue that the community (and doctors) need to get their heads around, because the psychs have been relying on the bounded rationality of others (myself included) in trying to understand this over the years, in order to present this facade of 'neuro' ME sufferers being included in their research (even though Wessely and gang 'don't believe in ME).

    It's comically ironic that the desperate attempt to do a quick and dirty negative XMRV study led to this issue with the research cohorts revealing itself.
  18. oceanblue

    oceanblue Senior Member

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    Hi Angela

    Just one comment:

    I think this goes to the heart of it. If YOU were applying the PACE criteria you would exclude ME patients as having a neurological or other organic diseases. But those running the trial don't accept the WHO classification or see ME as an organic disease, so they won't exclude patients on that basis. That's what I meant when I said that 'in practice' the PACE criteria won't exclude ME patients.

    plus a few clarifications:

    Yes, it's that 2003 Ambiguities paper, the source for the exclusions used by PACE, as cited by the Protocol and as referenced by me earlier in this thread.

    There seems to be some confusion over this paper. It was first-authored by Reeves but on behalf of the International Working Group on CFS that included Lenny Jason and Nancy Klimas. All it does is try to tidy up Fukuda a bit. The 2005 paper is completely different, solely the work of Reeves and the CDC, which launched the batty 'empirical defintion': PACE doesn't mention or use this definition. Here's what the 2003 paper said:
    ----
    The relevant quote was "head injury with residual neurologic deficits", which doesn't apply here.

    I've posted my understanding of this here (post #19), it's based on both the published Protocol and the full 200-page unpublished protocol that Dolphin has posted somewhere.
  19. Angela Kennedy

    Angela Kennedy *****

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  20. Angela Kennedy

    Angela Kennedy *****

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    OK! to confuse matters even more, Here is the Oxford and Fukuda exclusions according to the RCPCH. I have lost my access to both Fukuda and Oxford original articles, unfortunately. But we need to compare them here, because they are different to the 'exclusions' Reeves et al discuss in 2003, indicating Fukuda was not being used by PACE. So I'm using the RCPCH ones for the time being, will use NICE as well later, and when I have the original articles again, I'll show them in comparison.

    OXFORD EXCLUSIONS according to RCPCH guidelines (page 113 of PDF)
    http://www.rcpch.ac.uk/Research/ce/RCPCH-guidelines

    Fukuda exclusions according to RCPCH

    Now Reeves 2003 write this:

    This looks like Reeves' 'exclusions', NOT Fukuda's which were not exhaustive, according to Reeves et al here.

    Another thing to remember is that the ad hoc nature of clinical diagnosis is put to good use here (in all the CFS-only research criteria) to allow a RESEARCH doctor to say "This person in front of me has some signs of organic dysfunction. I don't really know why- but as I'm trying to weed out organic dysfunction from my research cohort, this person is excluded".

    Another problem is that use of Oxford correctly (and in the way that suits the psychs) renders both London and Fukuda superfluous, one of the key objections some of us made right at the beginning of the PACE trial. We've also already seen that the way London was used could allow people to be designated 'London ME' even if they were very similar to Oxford, and neurological symptoms and signs are not necessary to get a London designation (remember London were also supposed to be 'research' and not 'clinical' criteria). If you put London against Ramsay or CC, for example, this becomes obvious.

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