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PACE Trial and PACE Trial Protocol

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

  1. Bob

    Bob

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    Thanks Dolphin. I did set up a thread on the Cochrane Review, some time ago, but it didn't attract any interest, so I wondered if I was replicating other discussions that I hadn't seen. I couldn't find any substantial discussions of Cochrane, with a forum search. And I wondered if any other CBT reviews had already been discussed. Are you aware of any discussions?
  2. Dolphin

    Dolphin Senior Member

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    There's a thread on:
    Cognitive Behavioral Therapy and Graded Exercise for CFS: A Meta-Analysis (Castell)

    http://forums.phoenixrising.me/index.php?posts/229430/

    Most/nearly all of the threads that have been set up are on papers that have come out since this forum was set up.
    Bob likes this.
  3. Bob

    Bob

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  4. Bob

    Bob

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    On another thread, Firestormm pointed out that we do actually now have a way to assess how useful and meaningful the 'moderate' improvements were...
    The 'moderate' improvements failed to improve lost-working hours, and failed to decrease benefits claims, and failed to decrease private financial claims.
    So now we know exactly how useful the 'moderate' improvements are!

    Dolphin, Valentijn and ukxmrv like this.
  5. Bob

    Bob

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    MPs are to investigate need for drug companies to share clinical trial data
    http://www.bmj.com/content/345/bmj.e7980

    "MPs are set to investigate drug companies’ sharing of clinical trial data, after mounting pressure on the issue, the chairman of the health select committee has announced."
    Dolphin likes this.
  6. Bob

    Bob

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    Dolphin likes this.
  7. Graham

    Graham Senior Moment

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    Thanks for the note about the BMJ campaign. I have written to Fiona Godlee and Trish Groves thanking them, and drawing attention to our concerns over the PACE trial.
    Dolphin, Purple, Valentijn and 2 others like this.
  8. Bob

    Bob

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    I can't help feeling that their 'campaign' applies to all medical trials, except the PACE Trial.
    (Obviously the PACE Trial is beyond all possible reproach :rolleyes:)

    But I'm sure that they will appreciate your email, esp as you mentioned the PACE Trial! :)
  9. Simon

    Simon

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    That's an inspired idea. Bob's probably right, but definitely worth a shot.
    Bob likes this.
  10. Esther12

    Esther12 Senior Member

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    It probably would be worth collecting relevant quotes somewhere. I've seen a few around, but never done anything with them. It is quite funny to have this move towards recognising the problems with statistical manipulation and deviations from protocols coming from those who otherwise seem to want to pretend that the problems patients have with the PACE trial is that we're just anti-science, or anti-psychiatry.
    Bob likes this.
  11. Graham

    Graham Senior Moment

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    Following the reply to the Countess of Mar (pasted below), I have written again to Dr Godlee of BMJ to draw her attention to this, and explained our concerns over their standards for "recovery". We can but hope.



    Health: Controlled Trials

    Question

    Asked by The Countess of Mar
    To ask Her Majesty's Government whether the refusal by researchers to publish trial data on recovery rates and positive outcome rates specified in their application for grant funding provided by the Department of Health, the Medical Research Council, the Scottish Office and the Department for Work and Pensions for "Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial" contravenes the agreement the researchers entered into when the award was made.[HL3151]
    The Parliamentary Under-Secretary of State, Department for Business, Innovation and Skills (Lord Marland):The PACE trial: A Randomised Controlled Trial of CBT, graded exercise, adaptive pacing and usual medical care for the chronic fatigue syndrome, was funded by a Medical Research Council (MRC) grant to Queen Mary, University of London.
    While the MRC strongly encourages the publication and dissemination of the findings of all MRC-funded research it does not require the publication of underlying research data. As an MRC grant, the study was subject to the RCUK (Research Council UK) and MRC terms and conditions; no additional requirements around publication were specified by the other funders of the study.
    The findings of the PACE study have been reported in The Lancet, in March 2011 (published online in February 2011) and in PLOS ONE in August 2012. These papers included the results of analyses of positive outcome rates.
    The MRC is aware that Queen Mary University London received a request under the Freedom of Information Act relating to data on recovery rates and positive outcome rates which relates to an analysis initially planned by the investigators in the original protocol for the study and which was published in 2007. It is understood that the request was declined by the university as this originally planned analysis was superseded and therefore not undertaken during the study.
  12. Dolphin

    Dolphin Senior Member

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    I have just been reading, "Keeping patients safe while avoiding bias in randomised trials" http://www.bmj.com/content/344/bmj.e3297

    It mentions:

    This latter paper is free at: http://www.biomedcentral.com/content/pdf/1471-2288-8-12.pdf

    Although the scenario isn't exactly the same, on a quick skim, it does talk about the problem of changing outcome measures, so could be useful.
  13. Graham

    Graham Senior Moment

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    Someone likes our MEAnalysis videos. But they do say that if you work in films, don't work with animals.

    Valentijn likes this.
  14. Valentijn

    Valentijn Activity Level: 3

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    It now seems to be at
    www.youtube.com/watch?v=mjJG2JwLJMI
  15. Marco

    Marco Old blackguard

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    The paper referenced in this thread, while interesting in it own right, has a very useful discussion of the impact of and how to properly measure placebo effects :

    http://forums.phoenixrising.me/index.php?threads/placebo-effect-may-be-genetic.20878/

    Catechol-O-Methyltransferase val158met Polymorphism Predicts Placebo Effect in Irritable Bowel Syndrome

    Including concepts such as the need to include a 'waiting list control' to be able to exclude the natural disease progression and reversion to the mean and the impact of 'augmented placebo' on outcomes.

    Enjoy!
  16. Dolphin

    Dolphin Senior Member

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    This last paragraph makes it sound like it is impossible to get the data, that this data wasn't collected during the study and thus can't be given.

    This is totally incorrect. It is not like some study where the researchers decided to take a measurement and then changed their mind and decided not to take the measurement before the study started. These things were measured all the way through the study but after the study was finished, the investigators decided to not to calculate the answers.

    I wonder were Lord Marland and his department misled? That would be serious I would have thought.

    Either way, it seems to me that the response given in the House of Lords is a bit misleading.
  17. Graham

    Graham Senior Moment

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    That's interesting Dolphin. I read the word "analysis" to mean "calculation", and so interpreted it as "we didn't do this particular calculation because we chose to do a different one". But I now see that there are other ways of reading it that are misleading, suggesting that the FOI request would have been impossible to answer. The use of the word "during" is clearly the weasel word. There's a lot of that in various statements by the psychosocial brigade. No wonder they can claim that they never meant this or never said that.
    Valentijn and Dolphin like this.
  18. Dolphin

    Dolphin Senior Member

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    FWIW:

    http://online.wsj.com/article/SB10001424127887324705104578147333270637790.html



    -----
    @Maxwhd (Twitter) pointed out this is used in CBT manual for PACE Trial: http://www.pacetrial.org/docs/cbt-therapist-manual.pdf


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  19. Firestormm

    Firestormm Guest

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    :rofl: Oh boy! I've heard it all now! SMART!! :D
  20. Dolphin

    Dolphin Senior Member

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    http://www.actionforme.org.uk/get-i.../pace-motion-tabled-for-short-dabate-in-lords

    Firestormm and Bob like this.

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