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PACE Trial and PACE Trial Protocol

Discussion in 'Latest ME/CFS Research' started by Dolphin, May 12, 2010.

  1. ukxmrv

    ukxmrv Senior Member

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    I jotted down these rough notes from that part

    ((start))

    6 minute walk test, i have issues for the 6 minute walk test. Reasonably accurate?

    If you come back in a few weeks you have done it before, it's no big deal

    who is monitoring the tests, gradulate students, how do they do it

    don't give anyone any feedback, don't tell them how they are doing

    both x and I will need a guard when we leave because I am going to talk about the PACE

    I'm going to talk about the only objective test ... the 6 minute walk test

    so we saw that there were about 110 people in the treatment arms. The data on the test is based on

    51% of the 110 didn't complete the 6 mwt - why?

    what can I convert that to that can give us a xx

    is this effect large enough to be a meaningful difference

    miles per house

    2.3 baselines 1.9?

    That's sort of walking xx

    There are energy cost tables, research tool

    called "met" or metabolic metabolism

    2 mph equates to 2 mets approx

    severely disabled. unlikely to be candidates for a heart transplant as they would be unlikely to survive it

    quite likely to be motivation x
     
  2. Bob

    Bob

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    To help fill in the gaps...

    He converted the distance walked, for the 6 minute walking distance test, to a 'speed'.

    He calculated the speed to be 1.9 mph at baseline, and 2.3 mph at end of the trial.

    He said that's not a fast pace, but it's the sort of speed that someone would amble round an office.
     
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  3. Bob

    Bob

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    Recent study by Knoop and Bleijenberg. (I don't remember seeing it posted on this forum before.)

    They've published on this topic before, where they focus only on fatigue, and not on physical disability, assuming that changing perceptions of fatigue is therapeutic for CFS patients.



    The role of the therapeutic relationship in cognitive behaviour therapy for chronic fatigue syndrome.
    Heins MJ, Knoop H, Bleijenberg G.
    Behav Res Ther. 2013 Apr 9;51(7):368-376. doi: 10.1016/j.brat.2013.02.001.
    http://www.ncbi.nlm.nih.gov/pubmed/23639303

    Abstract
    ...
    Recently, it was found that changes in fatigue-perpetuating factors, i.e. focusing on symptoms, control over fatigue, perceived activity and physical functioning, are associated with and explain up to half of the variance in fatigue during CBT for CFS.
    ...
    A large part of the variance in post-treatment fatigue (25%) was jointly explained by outcome expectations, working alliance and changes in fatigue-perpetuating factors.
     
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  4. Simon

    Simon

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    Er, 25% of the variance explained by three factors is neither large nor impressive, esp as the first two could well lead to self-report bias.
     
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  5. dmbaken

    dmbaken

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    Hi, our (New Zealand) government is putting together a report on ME/CFS and it looks like they are going to say that CBT and GET are the best treatments. Probably influenced by the NICE Guidelines and the PACE Trial. We would like to present them with some contrary findings before the report is finalised. I thought this might be a good thread to find people who could let us know of any contrary findings.

    Thanks in anticipation.

    Don
     
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  6. alex3619

    alex3619 Senior Member

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    dmbaken Have you read the thread? Its long but a lot of issues are covered here relating to this and there are a lot of links. Are there contrary findings? They contradict themselves! Also every study using objective measures has failed to find functional improvement from CBT/GET. The improvement is subjective only, and even then only in an occasional patient, and looks like being mostly due to bias or changes in attitude, not capacity.

    It is hard to find specific and clear contrary findings because nobody else (aside from psychiatrists) is doing this. For solid evidence I would start with the research from Stevens and Snell on exercise physiology, which shows a massive decline in energy production. The six minute walking test is probably not valid for ME, so even their not very favourable data is probably biased in their favour.
     
    Shell likes this.
  7. Shell

    Shell Senior Member

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    On the self reporting by patients showing change in attitude rather than actual functional improvement; I caught myself at this when talking with the Cardiologist this week. When he asked if symptoms of OI had improved on the new drug, I hesitated. In fact the OI is somewhat worse but I didn't have the heart to tell him that and ended up apologetically admitting things weren't much better.
    I realised that partly this is about wanting to seem grateful for the help (I am grateful) but also not wanting the doc to feel like his approach isn't working and being afraid that if I admit it isn't making huge benificial changes that I will be labelled somehow. Part of this is that I am acutely aware that I have dx which make so many docs dismissive. It's a fine line of egg shells we tread with docs.
    D'you get what I mean?
     
    Bob likes this.
  8. alex3619

    alex3619 Senior Member

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    I think I understand your point Shell. So many patients probably tell psychiatrists what they want to hear, or something thats kind of like what they want to hear like improved attitude or mood: thats a recognized form of bias. As you have stated, this happens with regular docs too, even cardiologists. We don't want to lose our lifeline, we don't want to disappoint, we don't want to be put in the too hard basket ... it makes things hard for us, particularly if we have lots of cognitive issues at the time. Sometimes its so good to be just doing something even if it does not really help: its empowering, as opposed to the other place.
     
  9. Valentijn

    Valentijn Activity Level: 3

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    Regarding PACE:
    • Oxford definition was used to select patients, which only focuses on chronic fatigue. Explicit exclusion of patients in which fatigue was not the primary symptom could have kept out most ME patients (with PEM, pain, OI, etc as most prolific symptom). Hence study results relate to fatigue patients, not ME/CFS patients.
    • When comparing to the "control" group (SMC), only something like 13% of the fatigue patients "recovered".
    • Recovery was defined to allow for minimal or no improvement among fatigue patients.
    • All recovery criteria were subjective - no objective measurements were considered.
    • The only objective measurement, the 6 Minute Walking Test, was not used to determine recovery, and showed no statistically significant improvement among patients receiving CBT.
    • Adverse events were defined and categorized in a manner to hide and minimize episodes of PEM.
    • No objective improvements were shown in physical capacity, work rates, studying, or receipt of public benefits (welfare).
     
  10. Esther12

    Esther12 Senior Member

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    Broadly, what PACE shows is that CBT and GET are able to lead to minor improvements in questionnaire scores in a trial which is necessarily unblinded, and with questionable controls. It seems deeply uncertain that CBT and GET are any more helpful for improving disability in CFS patients than a pure placebo like homeopathy would be, and in addition to that, they bring the dangers that occur with the medicalisation of people's cognitions and behaviours. If they are to be promoted as treatments for CFS, it should be argued that they are tightly controlled. In PACE, all treatment sessions were recorded, and if they want to claim that PACE shows these treatments are safe, similar supervision would be required when they adopt these interventions.

    Personally, I think it would be best if patients were provided with the resources that would allow them to choose to pay for CBT or GET in the open market if they so wished, rather than having a central organisation claiming that they are helpful for patients when there is so little evidence that this is the case.

    There are some summaries of problems with PACE posted here:

    http://forums.phoenixrising.me/inde...ques-links-thread-no-discussion-please.14121/

    Given the difficulty of defining what 'CFS' is, and who has it, there should be great caution in recommending any treatment to patients just because they have a diagnosis of CFS.
     
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  11. Bob

    Bob

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    Good summary, Val.
    I've taken the liberty of building on it, adding some extra points, and slightly re-wording a couple of your sentences... Let me know if it's OK with you, or not...

    • Oxford definition was used to select patients, which only focuses on chronic fatigue. Explicit exclusion of patients in which fatigue was not the primary symptom could have kept out most ME patients (with PEM, pain, OI, etc as most prolific symptom). Hence study results relate to fatigue patients, not ME/CFS patients.
    • On average, patients were left with severe disability after treatment with CBT or GET.
    • Only approx 13% of patients achieved a minimum level of 'improvement' after treatment with CBT or GET, when using subjective measures, compared with the SMC control group.
    • When comparing to the "control" group (SMC), only something like 13% of the fatigue patients "recovered".
    • The measure of 'recovery' was a purely research endpoint, which did not indicate either an improvement or a 'recovery' in the lay sense of the word. A 'recovery' could be recorded even if a patient deteriorated after treatment, and had severe impairment or severe disability. Recovery was defined to allow for minimal or no improvement among fatigue patients.
    • All 'recovery' criteria were subjective - no objective measurements were considered.
    • The only objective disability measurement, the 6 Minute Walking Test, was not used to determine recovery, and showed no statistically significant improvement among patients receiving CBT or GET. On average, patients were left severely disabled after treatment.
    • Adverse events were defined and categorized in a manner to hide and minimize episodes of PEM. Deterioration rates, as a measure equivalent to the improvement rates, have not yet been published.
    • For the other objective measures used (working hours, private insurance and public welfare benefit claims), there were no significant improvements in any of these measures after treatment with CBT or GET.
     
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  12. Bob

    Bob

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    Good points, Esther.
     
  13. Mark

    Mark Acting CEO

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    It might be worth pointing them at what's happening in the US: in particular, the FDA Workshop for Drug Development has some excellent patient testimony (and some good quotes on the PACE trial and the outdated UK approach). See our article here (part two will be up in a couple of days, and video of the whole workshop is available online). Also there's an analysis of the PACE trial here. The Rituximab research is also worth highlighting. It may be unrealistic to expect NZ to recommend treatments like Ampligen and Rituximab at this stage, but at least that science should help anyone who's not grossly prejudiced to see that real progress is now being made on understanding and treating the immune dysfunction in ME/CFS.
     
  14. Bob

    Bob

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    Just a brief media quote from Esther Crawley...

    Doctory's diary: the less doctors do, the better for everyone
    The Daily Telegraph Monday 13 May 2013
    http://www.telegraph.co.uk/health/h...-less-doctors-do-the-better-for-everyone.html

    With reference to treating CFS in children and adolescents:

    "Treatment remains regrettably unsatisfactory, as Dr Esther Crawley, a Reader in child health at Bristol University who organised the study acknowledges, noting the standard regime of graded exercises and cognitive behavioural therapy is only “moderately” effective."






    .
     
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  15. Bob

    Bob

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    US journalist wants to speak with people who were on the PACE Trial | 13 May 2013
    by Tony Britton on May 14, 2013
    A US-based medical journalist researching ME/CFS treatments would like to speak with people who took part in the PACE Trial.
    ...
    http://www.meassociation.org.uk/?p=15449

    .
     
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  16. Dolphin

    Dolphin Senior Member

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    EAPM2013:1st Annual Scientific Meeting of the European Association of Psychosomatic Medicine - 4- 6 July

    Sharpe:



    After the big long first box, the bits I'm posting are all on the PACE Trial.
    ~~~~~~~~~~~~~~~~~~~~~~~~








     
  17. Dolphin

    Dolphin Senior Member

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    So one of the PACE Trial PIs is going to give very speculative opinions on these issues, but they won't share some concrete data, including data they said they'd publish (in a trial that cost £5m).
     
  18. Esther12

    Esther12 Senior Member

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    I'd love more info on that Sharpe presentation. I wonder if he will focus on 'stigma' and the 'failure to understand how mind and body interact' (the reasons he like to claim he is criticised) or 'failure to release data on outcome measures laid out in protocol' and 'false claims made and left uncorrected in journals and media' (the actual criticisms made of PACE).
     
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  19. Graham

    Graham Senior Moment

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    And in the right corner, in blue, Scientific Reason: in the left corner, in green, The Sharp Presentation. May the best man win.
     
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  20. Dolphin

    Dolphin Senior Member

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    No change in 6 minute walking test for CBT over SMC comes to mind. The main clear thing is the differences between subjective and objective outcomes but doubt that's what he's talking about.

    The more I think about this, the more it annoys me: he's hardly likely to criticise the trial, how the results were presented, etc. so this is likely to be a completely unbalanced presentation.
     
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