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PACE Trial and PACE Trial Protocol

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

  1. Dolphin

    Dolphin Senior Member

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    from

    This refers to the "within normal range" data presented in the Lancet paper, in case some don't know what is being referred to.
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  2. biophile

    biophile Places I'd rather be.

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    Thanks Dolphin, another example to add to the collection (that is at least 5 so far from medical journals):

    FWIW, I posted this comment on PLoS:

    http://www.plosone.org/annotation/listThread.action?root=71123

    -

    Cited paper on conventional CBT for CFS did not report a 30% 'full recovery' rate

    Posted by biophile on 31 Aug 2013 at 06:02 GMT

    In their recent paper [1], Lakhan & Schofield state that: "However, the limitations of CBT noted above apply equally to somatization disorders - for example, only 30% of patients with CFS experience full recovery following conventional CBT." Without going into whether CFS is a "somatization disorder" per se, the cited paper for this statement (White et al, 2011) [2] did not report on a full recovery, which was made clear in a subsequent authors' reply. [3]

    White et al had instead reported on the proportion of participants within 'normal range' at followup, defined as ≤ 18/33 points in fatigue score (CFQ, Likert scoring) and ≥ 60/100 points in physical function (SF-36 health survey). The proportion of participants meeting this threshold at followup was 15% for SMC (specialist medical care) and 30% for SMC+CBT, which translates to a Number Needed to Treat of about 7.

    A similarly inaccurate comment about full recovery was made in the Lancet editorial [4] which accompanied the CFS study in question [2], which the Press Complaints Commission in the UK later ruled was misleading and raising a breach of Clause 1 (Accuracy) of the Code, because the authors of the editorial failed make it clear that their comment reflected their personal view rather than the paper being commented on.[5]

    However, it should also be noted that even the authors of the Lancet editorial in question (Knoop & Bleijenberg) have previously co-authored papers on CFS in which 60-65/100 points in physical function was not only regarded as non-recovered [6], but even reflective of "severe" problems with physical functioning.[7][8][9]

    Upon closer inspection, it becomes more obvious that the thresholds used do not indicate a full recovery. It was theoretically possible for a participant to be within 'normal range' at baseline, despite the same scores meeting trial eligibility criteria for "disabling fatigue". In practice, almost no participants reported normal fatigue at baseline, but 13% of participants had reported normal physical function at baseline, despite the same scores counting as "significant disability".[10][2]

    These low thresholds were seemingly derived from the questionable use of normative population data.[11][12]

    References:

    1. Lakhan SE, Schofield KL (2013) Mindfulness-Based Therapies in the Treatment of Somatization Disorders: A Systematic Review and Meta-Analysis. PLoS ONE 8(8): e71834. doi:10.1371/journal.pone.0071834 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0071834

    2. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, et al. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377: 823–836. doi: 10.1016/s0140-6736(11)60096-2. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065633

    3. White PD, Goldsmith KA, Johnson AL, Walwyn R, Baber HL, Chalder T, Sharpe M, [on behalf of the coauthors]. The PACE trial in chronic fatigue syndrome — Authors' reply. The Lancet, Volume 377, Issue 9780, Pages 1834 - 1835, 28 May 2011 (Published Online: 17 May 2011). doi:10.1016/S0140-6736(11)60651-X http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60651-X/fulltext

    4. Bleijenberg G, Knoop H. Chronic fatigue syndrome: where to PACE from here? Lancet. 2011 Mar 5;377(9768):786-8. Epub 2011 Feb 18. DOI: 10.1016/S0140-6736(11)60172-4 http://www.ncbi.nlm.nih.gov/pubmed/21334060

    5. http://www.pcc.org.uk/news/index.html?article=ODQwOQ==

    6. Knoop H, Bleijenberg G, Gielissen MFM, van der Meer JWM, White PD. Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome? Psychother Psychosom 2007; 76: 171–76. PMID 17426416.

    7. van't Leven M, Zielhuis GA, van der Meer JW, Verbeek AL, Bleijenberg G. Fatigue and chronic fatigue syndrome-like complaints in the general population. Eur J Public Health. 2010 Jun;20(3):251-7. Epub 2009 Aug 18. PMID 19689970 http://eurpub.oxfordjournals.org/content/20/3/251.long

    8. Heins M, Knoop H, Nijs J, Feskens R, Meeus M, Moorkens G, Bleijenberg G. Influence of symptom expectancies on stair-climbing performance in chronic fatigue syndrome: effect of study context. Int J Behav Med. 2013 Jun;20(2):213-8. doi: 10.1007/s12529-012-9253-2. http://www.ncbi.nlm.nih.gov/pubmed/22865100

    9. Tummers M, Knoop H, van Dam A, Bleijenberg G. Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2205-15. doi: 10.1017/S0033291712000232. Epub 2012 Feb 21. http://www.ncbi.nlm.nih.gov/pubmed/22354999

    10. Queen Mary, University of London. FOI Request: 2013/F42. https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1303c&L=co-cure&F=&S=&P=6559

    11. Feehan SM; Liverpool ME Support Group. The PACE trial in chronic fatigue syndrome. Lancet. 2011 May 28;377(9780):1831-2. Epub 2011 May 16. doi: 10.1016/S0140-6736(11)60688-0 http://www.ncbi.nlm.nih.gov/pubmed/21592556

    12. Kewley AJ. The PACE trial in chronic fatigue syndrome. Lancet. 2011 May 28;377(9780):1832. Epub 2011 May 16. doi:10.1016/S0140-6736(11)60681-8 http://www.ncbi.nlm.nih.gov/pubmed/21592552
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  3. Dolphin

    Dolphin Senior Member

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    For what it's worth (see from the 3rd sentence on):


    [Aside: It should be Wiborg not Wibourg]


    From
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  4. Bob

    Bob

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    I've just looked at the first reference in this quote (White et al. 2011), and it's for the PACE trial.
    The details for the second reference (Lancet, 2011) are as follows:
    Lancet. Patients’ power and PACE. The Lancet. 2011;377:1808.
    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60696-X/fulltext

    It's the ridiculous Lancet editorial that attacks detractors of the PACE trial.
    The editorial certainly does not critique the use of an overly inclusive diagnostic criteria for CFS studies.
    The most it says (discussing the correspondence in response to the PACE trial) is "Many of the letters critique the definitions of secondary outcomes, question protocol changes, and express concern over generalisability."
    So perhaps the Lattie et al. paper is making a reference to the public letters published in response to the PACE trial.
    The letters are all listed together with the Lancet editorial as 'linked articles', on the right-hand side of the editorial webpage.

    It's a shame that Lattie et al. didn't give references to the specific letters that they are referring to.
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  5. Bob

    Bob

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    Just for interest...
    Re the Wiborg 2010 study cited in the Lattie 2012 paper...

    The Wiborg study was a re-analysis of three randomised controlled trials previously conducted to evaluate the efficacy of CBT for CFS. In all the samples re-analysed, actigraphy was used in the trials to assess the level of physical activity prior and subsequent to treatment or a control group.

    The Wiborg abstract says:

    "Results: Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue. Across the samples, the mean mediation effect of physical activity averaged about 1% of the total treatment effect. This effect did not yield significance in any of the samples."


    How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity.
    Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G.
    August 2010
    Psychol Med. 2010 Aug;40(8):1281-7.
    doi: 10.1017/S0033291709992212.
    http://www.ncbi.nlm.nih.gov/pubmed/20047707
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  6. Tom Kindlon

    Tom Kindlon Senior Member

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    Yes, you could be right.

    Never heard of him. ;)


    FWIW, Wiborg et al. was referenced in two of the Lancet letters:
    Andrew Kewley:
    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60681-8/fulltext
    and my one:
    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60684-3/fulltext
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  7. Bob

    Bob

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  8. Tom Kindlon

    Tom Kindlon Senior Member

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  9. ukxmrv

    ukxmrv Senior Member

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    The press conference is important as some of the reporters went on to write newspaper or TV reports on PACE. At the press conference they were given the spin on the results and also given printed material to use in their work.
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  10. Dolphin

    Dolphin Senior Member

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    From:
    ----
    This is a recognition of the potential value of patients' input.

    [With the issue of descriptions of non-pharmacological interventions, the PACE Trial is probably better than most, with the release of the manuals; but the point I think would also apply to other times patients give input.]
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  11. Dolphin

    Dolphin Senior Member

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  12. Esther12

    Esther12 Senior Member

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    I couldn't access that page, or find any Dr larun by google. Any chance we'll get the protocol defined outcomes from this?
  13. Esther12

    Esther12 Senior Member

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    Oops. Found her with a new Google search.

    'Identity and coping experiences' abstract from her didn't look terrible considering the nature of that sort of work. Some hope?

    Just found one of her papers on exercise therapy, arguing that while the evidence for efficacy was not currently great, the "empirically based hypotheses about disease mechanisms" it was likely that future studies would show GET to be a good 'un.
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  14. Dolphin

    Dolphin Senior Member

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    Dr. Larun wrote these three PubMed-listed pieces:
    http://www.ncbi.nlm.nih.gov/pubmed/?term=larun+chronic+fatigue+syndrome
    As I recall, she is a physiotherapist (=physical therapist) by training.

    My impression is she is more into GET/exercise than I'd like - sample quote:

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  15. Dolphin

    Dolphin Senior Member

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    Somebody just posted this on another forum. I don't think they post here so thought I'd post it:

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  16. Graham

    Graham Senior Moment

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    Pity it wasn't 20 years. At least they may have got the analysis right.
  17. Dolphin

    Dolphin Senior Member

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    Not sure I ever read this before. And don't think it was ever highlighted:
    She seems to be summarising the big document "Magical Medicine" by Malcolm Hooper that was written before the results were out. I have only read a small part of Magical Medicine.

    This piece by Karen is quite cynical of individuals and bodies, probably over cynical for my liking. However, perhaps for some people who are not sceptical of all, it might have a value.
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  18. Dolphin

    Dolphin Senior Member

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    I read read part 2:

    I preferred this to part 1. It dealt more with issues rather that speculating about motivation and the like.

    For the old hands here, nothing new I think. But perhaps it might be a useful summary of some critiques of the trial for somebody new.
  19. aimossy

    aimossy Senior Member

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    I was trained in cbt and pacing as an occupational therapist. I do not read anything about it as a matter of my own principle because this being advocated as a cure really makes me sooo MAD!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
    I use cbt and pacing in order to help myself cope with being this sick yes. but I stress the word HELP. has it improved my illness or physical and mental fatigue or any of the weird crap that happens to me and is affecting my activities of daily living NO NO NO. it just helps me to adjust my thinking to feel less stressed about it happening,oh for gods sake. cbt and pacing are a constant thing,its something you are always working on in our cases.
    im so glad people are pulling it to threads because I get to spiting level about it and so mad its advocated as a fix for me/cfs in this way! I can barely cope with thinking about it.
    some people find mindfulness better or just going to or being involved with a support group.if this is off thread or topic I apologise I had a maddening need to vent.
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  20. Graham

    Graham Senior Moment

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    Aimossy, venting is good! Venting is survival! You are in good company here.
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