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2 Good Letters in the BMJ re PACE

Discussion in 'General ME/CFS News' started by Orla, Sep 26, 2013.

  1. Orla

    Orla Senior Member

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    http://www.bmj.com/content/347/bmj.f5731

    Chronic fatigue treatment trial

    People want to learn as much as possible from the PACE trial for chronic fatigue syndrome
    BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5731
    (Published 25 September 2013)
    Cite this as: BMJ 2013;347:f5731
    Drugs: CNS (not psychiatric) Infectious diseases Musculoskeletal syndromes Neuromuscular disease

    Tom Kindlon, assistant chairperson1 Author Affiliations
    tkindlon@maths.tcd.ie

    One reason that the minutes are sought for the PACE (Pacing, Graded Activity, and Cognitive Behaviour Therapy—a Randomised Evaluation) trial, which looked at the effectiveness of treatments for chronic fatigue syndrome, is to find out why outcome measures were changed.1 None of the three primary outcomes were reported as in the protocol.2 The recovery criteria in the protocol were very different from what were reported on.2 3

    Non-pharmacological therapies are less well regulated than pharmacological ones. For example, there is no equivalent to the yellow card system for adverse events seen with these therapies, so trial reporting becomes more important. Reporting of harms in trials of cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has generally been poor.4 Harms reporting in the PACE trial was improved but problems still remain.4 5

    Outside of trials, people with ME/CFS have reported being made more ill by such interventions, but this has largely been ignored,4 which can make people frustrated.

    This was an important trial: £5m (€6m; $8m) of taxpayers’ money was invested in it, and it was meant to be the definitive trial. It’s understandable that people want to get as much information from the trial as possible.

    Notes
    Cite this as: BMJ 2013;347:f5731

    Footnotes
    Competing interests: TK works in a voluntary capacity for the Irish ME/CFS Association.

    References
    1. Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)FREE Full Text

    2. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol2007;7:6.CrossRefMedline

    3. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med2013; published online 31 Jan.

    4. Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME2011;19:59-111.

    5. Kindlon T. The PACE trial in[/QUOTE]
    chronic fatigue syndrome. Lancet2011;377:1833.Medline

    -------------------------------------------------------------------------------------------------------------------------------------
    http://www.bmj.com/content/347/bmj.f5740

    Letter

    Chronic fatigue treatment trial

    What’s the problem with sharing research committee’s discussions?

    BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5740 (Published 25 September 2013) Cite this as: BMJ 2013;347:f5740

    Allan House, academic psychiatrist1

    Author Affiliations

    1University of Leeds, Leeds LS2 9LJ, UK

    a.o.house@leeds.ac.uk

    I struggle to see the logic here,1 mainly because I can’t think what would be minuted in a professionally conducted meeting that could not be shared later, once the usual conditions about third party information and data still being prepared for publication have been applied. The debate might move on with some specific, even if fictitious, examples.

    Most people are (rightly) deeply suspicious about non-specific appeals to academic freedom or sensitivity of information as an explanation for opacity in public life.

    Notes

    Cite this as: BMJ 2013;347:f5740

    Footnotes

    Competing interests: None declared.

    References


    Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)
    FREE Full Text
    cigana, WillowJ, MeSci and 9 others like this.
  2. Esther12

    Esther12 Senior Member

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    Thanks Orla. Both helpful letters.
  3. Sasha

    Sasha Fine, thank you

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  4. peggy-sue

    peggy-sue

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    Tom Kindlon is my hero. :thumbsup:
    Sasha likes this.
  5. Tom Kindlon

    Tom Kindlon Senior Member

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    Thanks, guys.

    It was just a quick e-letter I wrote one night when frustrated by another article making out somebody from the ME community was being unreasonable looking for more information.

    Final version isn't too different from the original e-letter* which can be found with other e-letters here: http://www.bmj.com/content/347/bmj.f5355?tab=responses

    *They just edited it without contacting me, so got a nice surprise when it was published
  6. Richie

    Richie

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    The PACE boys and girls have to realise that CBT for exercise avoidance + exercise is unlikely to help/may harm:-
    a) those with genuine psychosomatic illness - other than fear of exercise, of course. They will need good psychiatric treatment.
    b) those with psycho-behavioural physiological syndromes such as burnout, adrenal burnout, enzyme breakdown under stress, unless accompanied by corrrect physiological treatment - physiological dose hormones , vits, mins etc.
    c) those with severe oxidative-nitrosative probs, Rituximab responsive B cell probs,etc. any more than CBT/GET would help lupus or MS or Sjogrens etc etc
    d) those with ongoing infection, whether causing actual M Encephalomyelitis, M encephalopathy, dorsal root ganglionitis, or other mimicking infections such as Lymes, Toxoplasmosis, candida etc.
    e) those who have been put in the waste basket when they have got entirely different problems such as sleep apnoea, but have been dismissed on the grounds that they must not be encouraged to believe they are ill.

    Normal medicine tests and treats appropriately. CBT/GET is still rooted int he gian FIB that we have a false belief problem.

    Pathetic.
  7. Battery Muncher

    Battery Muncher Senior Member

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    Great stuff Tom :thumbsup:
    Tom Kindlon likes this.
  8. Tom Kindlon

    Tom Kindlon Senior Member

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    There are now four replies to my letter. They can all be read for free at: http://www.bmj.com/content/347/bmj.f5731?tab=responses

    justy, Valentijn and MeSci like this.
  9. Tom Kindlon

    Tom Kindlon Senior Member

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    BMJ site seems to be temporarily on the blink.
  10. Tom Kindlon

    Tom Kindlon Senior Member

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    BMJ site working again.
  11. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    I just accessed the page OK.

    Arise, Sir Tom! :D (That means that I very much like your correspondence, in case there is any confusion!)
    Bob and Tom Kindlon like this.
  12. peggy-sue

    peggy-sue

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    I was there, liking you early on today.
    Thank-you so much for your hard work.:thumbsup:
    Tom Kindlon likes this.
  13. anciendaze

    anciendaze Senior Member

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    I don't suppose anyone has made the simple observation that depending entirely on self-reports for primary measures is a questionable practice when objective measures are possible, and the goal of therapy is to change illness beliefs, biasing self-reports. Is there any way such a study could fail? Why fund a study that can't fail?
  14. Tom Kindlon

    Tom Kindlon Senior Member

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    Anyone can post responses on the BMJ site if so inclined. I think this could be a useful point to make.

    Responses don't have to be long or referenced either e.g.
    http://www.bmj.com/content/347/bmj.f5355/rr/659993 (although if one wants to get published in the print journal, it is best to take some time; but a lot of people are likely happy enough to just get it up on the BMJ site - any response that goes up will have its own link so can be referenced in the future).
    cigana likes this.
  15. peggy-sue

    peggy-sue

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    ;) I'm not sure about that - but somebody else has pointed out how ridiculous it is to rely on the "patients' subjective opinions" regarding feeling a little bit better on questionaires, when the whole point of the BPS theory is that the patients have "false illness beliefs" in the first place.:p
    cigana and Bob like this.
  16. anciendaze

    anciendaze Senior Member

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    I'll give anyone who wishes permission to quote my comment above on the BMJ site. Due to my present "illness beliefs" even attempting to argue with them makes me want to lie down.
    greebo and peggy-sue like this.
  17. peggy-sue

    peggy-sue

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    Thanks for the comment, :thumbsup: anciendaze.
    and apologies that I had forgotten who said it.:redface:
  18. Tom Kindlon

    Tom Kindlon Senior Member

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    The BMJ published the White et al. letter but not* my reply or any of the other comments. :(

    *at least not so far, but I imagine if they were going to publish it, they would most likely have published it at the same time.
    Valentijn likes this.
  19. Esther12

    Esther12 Senior Member

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    It's the BMJ's patient revolution... sit down and shut up!

    The individual responsible at the BMJ should have to explain themselves, and their refusal to allow a clarification of White's misrepresentation of your concerns.
    peggy-sue, maryb, Valentijn and 2 others like this.
  20. Tom Kindlon

    Tom Kindlon Senior Member

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    My new 1000-word BMJ rapid response (i.e. e-letter) on the £5m PACE Trial, "PACE Trial: Simply giving a reason why an outcome measure was changed is not necessarily sufficient".

    It lists all sorts of reasons why I'm unhappy with the changes made to the PACE Trial outcome measures.

    I'm afraid I knew it would be too long to get published, so didn't spend as much time on the wording as other letters where I'm hoping they might be published in the print edition.

    http://www.bmj.com/content/347/bmj.f5963?tab=responses
    Last edited: Nov 8, 2013
    Valentijn, MeSci and peggy-sue like this.

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