1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
August 8th - What is the one thing about suffering with severe ME that the world needs to know?
Andrew Gladman brings our coverage of the Understanding & Remembrance Day for Severe ME, airing the voice of patients ...
Discuss the article on the Forums.

CBT for CFS in Adults: Face to Face versus Telephone Treatment-A RCT (Burgess et al)

Discussion in 'Latest ME/CFS Research' started by Dolphin, Jan 17, 2012.

  1. Dolphin

    Dolphin Senior Member

    Messages:
    6,705
    Likes:
    5,526
    * I've given each sentence its own paragraph

    Free full text on KCL site: http://www.kcl.ac.uk/innovation/groups/projects/cfs/publications/index.aspx
  2. Dolphin

    Dolphin Senior Member

    Messages:
    6,705
    Likes:
    5,526
    There were no objective outcome measures used.

    Primary Outcomes used:
    - Medical Outcomes Survey: short form (physical functioning subscale) (SF-36 PF)

    - Chalder Fatigue Scale
    - they used bimodal scoring for this (i.e. 0-11). At baseline, the values for the two groups were very high, showing the problems with this method. Means: TCBT=10.41, CBT=10.06
    They didn't give any figures for the numbers who weren't cases any more.

    The data includes a lot of missing data. But generally they didn't carry forward missing values, instead presenting data for those who filled in the questionnaire.

    Reading this, one might think TCBT didn't do as well as CBT:
    However, as the start of the discussion section says:
  3. oceanblue

    oceanblue Senior Member

    Messages:
    1,174
    Likes:
    343
    UK
    To point out the obvious, there was no reference group (let alone a placebo-attention control) so we don't know how much they would have improved anyway - maybe neither mode of CBT worked? Did they have SMC as per PACE?
    Both groups had smaller 12-month gains on SF36 than PACE (+19 from baseline), though they had been ill for about a year longer on average.
    Telephone (with 55% drop outs apparently unaccounted for): +14
    Face-to-face (34% drop outs): +12

    Can't believe they are still pursuing the ME Association membership link as a predictor of outcome.
  4. Snow Leopard

    Snow Leopard Senior Member

    Messages:
    2,302
    Likes:
    1,766
    Australia
    Blaming the patient never gets old!

    Maybe those who lost their job had greater severity, had been out of work for longer etc.

    Of course earlier, they said:
    The whole study is mostly meaningless though as there was no control group and no objective outcome measures.
  5. Calathea

    Calathea Darkness therapy

    Messages:
    1,086
    Likes:
    537
    Scotland
    I haven't the energy to go and read it, but "improvements in social adjustment" sounds ominous.
  6. Dolphin

    Dolphin Senior Member

    Messages:
    6,705
    Likes:
    5,526
    A few more random observations (had a phone call which stopped me complete)

    Claiming the Oxford criteria are widely accepted isn't widely accepted.
    But at least in this study, patients had to satisfy both.

    This could give the impression that the treatment should get all the credit.
    Controls also had significant improvements.

    This is a new one on me.
    I actually tend to have less confidence in the diagnosis at the start as sometimes people go on to be diagnosed with other conditions (either with more testing, new symptoms becoming apparent or whatever). After 10 years, I'd tend to be more confident of the diagnosis.
    I think this may be an excuse for cherry-picking - the longer term patients might be harder to treat (they actually bring this point up later to an extent).

    (over-reaching?) While the bit in bold might be a better way of doing research, potentially it might bias towards people whose illness is more stable/less out of control/troublesome - it might bias towards better results than real life.

    3 hours is quite a long appointment!
  7. Esther12

    Esther12 Senior Member

    Messages:
    5,263
    Likes:
    5,451
    The ten years things is odd. What new definition of CFS have they come up with?

    My guess would be they'd try to spin it as 'more than 10 years and they must be really crazy. Those stubborn malcontents.'

    Perhaps phrased more sensitively than that. I'm coming up for 10 years soon, whoop-dee-doo. What exciting quack-diagnosis will I get then? Fatigued Personality Type II?
  8. Dolphin

    Dolphin Senior Member

    Messages:
    6,705
    Likes:
    5,526
    They are referring to the Work and Social Adjustment Scale. One can see a copy in the full PACE Trial protocol, appendix 6.34: http://www.mediafire.com/?w9whdn7hh112b7y . It's probably not the worst questionnaire.
  9. Dolphin

    Dolphin Senior Member

    Messages:
    6,705
    Likes:
    5,526
    More random observations

    This means one can't see how many people said they were worse - they've been merged together with "helped a little".
    Not good "harms" reporting

    ---

    I think it was you, Esther12, who pointed out to me that single item satisfaction questionnaires are problematic.
    If anyone questions that, here's a reference:

    ---

    (Not important at all)
    I'm not sure I recall them here or elsewhere saying why somebody would be offered group CBT in the same clinic instead? Anybody recall anything?

    ---
    Baseline predictors of outcomes (same measure):

    Fatigue: No
    (Given the other two measures are predictors, this may be because so many of the scores are likely to be 10 and 11)

    Social adjustment scores (WSAS): Yes
    Physical functioning: Yes
    ---
    I don't understand how the following sentences fit together:
    I'm not sure I've seen talk of "post hoc power calculation" except perhaps in terms of what numbers they would have needed to get significance/what other studies might need.

    I think it might be easiest to just read it that they're saying a Cohen's d value of d=0.35. They say this later:
    and the abstract says:
    which would fit in with a cohen's d value of 0.35.

    I don't know what "post hoc" means in this context as I said e.g. did they just count people who completed and then made sure there was no extra weight to either group by averaging them out as 25 per intervention even if those weren't the final figures.

    -----
    As I pointed out, they excluded people whose illness had lasted more than 10 years:
    so this would have helped their results by this logic (but isn't mentioned in this way).

    Later on they say:
    A few paragraphs earlier, they said longer duration might lead to a worse outcome.
    Now, they're saying the results could have been better if the people with a long illness duration (who they decided to exclude) the results might have been better!
    (note: they don't go on to say, if they had been included the results might have been worse - they just say if they had been included, the results might have been better!)

    ---
    I don't know why they say this except that they are reaching.
    It seems quite possible that some of the participants who did not complete questionnaires had disimproved and
    therefore decided to disengage with the service.
    oceanblue likes this.
  10. Dolphin

    Dolphin Senior Member

    Messages:
    6,705
    Likes:
    5,526
    Some form of that is my guess also - but they don't say it and it seems to me

    Sorry to hear that. Coming up to 23 years myself.
  11. biophile

    biophile Places I'd rather be.

    Messages:
    1,386
    Likes:
    4,555
    Are the authors sloppy or lying?

    This Cochrane (2008) review shows that 40% in the CBT group had a "clinical response" vs 26% in the usual care group. So CBT is apparently responsible for only 14% of patients in the CBT group to report improvement, not 40% (although one could argue that the remaining 26% in the CBT group may report greater improvement than the 26% in the usual care group, but Cochrane does not go into that and only reports group differences in fatigue of SMD -0.39, 95% CI -.0.60 to -0.19). Furthermore, measures of "clinical response" were just various fatigue scales, whereas differences in average physical functioning scores between the CBT group and usual care group were not significant at both post-treatment and short-term followup.

    So what the Cochrane review actually suggests is, CBT may elicit a clinical response in fatigue for about 14% of patients, but without any significant improvement to physical function. Misrepresentation of the literature seems to occur frequently in biopsychosocial papers and shouldn't be allowed, I guess peer reviewers don't bother to do fact checking.

    Oh please, "unethical" LOL, just admit you couldn't be bothered and/or lacked the resources and/or were too scared to compare the small improvements in your cherished CBT with natural course / usual care. Do I sound like a recalcitrant yet?
  12. Snow Leopard

    Snow Leopard Senior Member

    Messages:
    2,302
    Likes:
    1,766
    Australia
    All of the language in the paper is speculative and reaching... Also, by misquoting the Cochrane review findings, they are insulting their readers.

    Why do they push this double standard I wonder? If you want to prove pharmacological efficacy you must do so with a double blinded RCT. The equivalent to the Chalder study would be doing an open label study. Why are open label studies considered highly questionable, yet this study is not? Why do psychiatrists insist on such a double standard?
  13. oceanblue

    oceanblue Senior Member

    Messages:
    1,174
    Likes:
    343
    UK
    Agreed it's outrageous they should report the Cochrane fatigue finding so misleadingly, but then 40% sounds so much better than +14%. You have to question the quality of the peer review if either a) they are not familiar with the most important meta-analysis of CBT (the data even is in the abstract) or b) they are, and let the misrepresentation pass.

    My recollection of Cochrane was that there was very little SF36 data (ie many studies didn't report on it) so the findings on that are rather circumspect, but I haven't reread it to check that.
  14. biophile

    biophile Places I'd rather be.

    Messages:
    1,386
    Likes:
    4,555
    Indeed. Collins et al (inc. Crawley) did the same recently by citing the PACE Trial for this statement: "Evidence from a recent evidence trial of cognitive behavioural therapy and graded exercise therapy indicated a recovery rate of 30-40% one year after treatment." (http://www.biomedcentral.com/content/pdf/1472-6963-11-217.pdf)

    Dubious definitions and misinterpretations of "normal" fatigue and "normal" physical function and positive clinical global impression aside, the same logic puts the SMC (standard medical care) de facto control group in the PACE Trial at a 15-25% "recovery" rate, leaving a true "recovery" rate (*cough* if you're aiming for the level of an 80 year old *cough*) of about 15% for CBT/GET, not 30-40%. Collins et al do not mention this and give the false impression that the 30-40% recovery rate is due to CBT/GET, just as Chalder et al did with Cochrane.

    Oh well I guess that is their modus operandi? It irritates me that we are the supposed irrational extremists for having doubts about the cognitive behavioural approach while it is apparently OK for CBT/GET proponents to give misleading statements in medical journals. These aren't regular journalists here, these people are supposed to be world class (sic) experts in their field.

    Yeah! They seem to think that because it is difficult to do such a study, then somehow that negates the problem.

    This seems to happen often, so either peer review in general is quite sloppy, or they are quite loose with interpretations of accuracy and let it slide, or they are purposely deceiving us. Not entirely related, but I have also wondered before, if these people believe CFS is mainly perpetuated by abnormal illness beliefs, then little white lies may be deemed acceptable to increase chances of "success" in CBT/GET.

    Not as much data as for the fatigue measures, but still some. The physical function at post-treatment was derived from 4 studies (318 participants) and PF at short/medium-term followup was derived from 3 studies (275 participants). The more recent PACE results may be enough to swing the average into significance.
    Sean and Angela Kennedy like this.
  15. oceanblue

    oceanblue Senior Member

    Messages:
    1,174
    Likes:
    343
    UK
    Like the argument that they are doing it for our own good - it is just possible they actually believe that!

    Thanks for digging that out. Given that PACE used a longer follow-up, and was generally a better-designed study (really), I tend to think the PACE results trump the limited meta-analysis. Unless the Cochrane SF36 studies all used proper attention-controls eg relaxation therapy.
  16. alex3619

    alex3619 Senior Member

    Messages:
    7,185
    Likes:
    11,254
    Logan, Queensland, Australia
    Hi biophile, I have been saying this is indeed their modus operandi for some time. Misquote, mistate, redefine then vacilate on their definitions - its about spin over substance. The PACE study is full of it. I was going to write a blog on confimation bias in ME research, then I thought no, an article or series of blogs on verificationism (institutionalized confirmation approach to science) and now I am wondering if my brain and resources are up to writing a book. This entire branch of medicine is an unsubstantiated theory - all of it. The biopsychosocial approach to ME is just an excellent exemplar of the field - full of deceptive claims, circular reasoning, deliberate ignoring of data that falsifies their theories, redefinition to solve issues as if redefining them changes anything much. Even with all their changes to established standards, all their false claims, they still fail to verify their models. I wonder if its not time to say the null hypothesis has been verified - psychosomatic medicine is disproved? I hope to look into that.

    Verificationism has some merits, some value, but only under certain circumstances. Those circumstances do not exist in ME research, and I think I might be able to show almost everything they are doing violates basic scientific standards and ethics. I am looking into this.

    Bye, Alex
    WillowJ, Dolphin and Angela Kennedy like this.
  17. biophile

    biophile Places I'd rather be.

    Messages:
    1,386
    Likes:
    4,555
    I had another quick look (http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001027.pub2/pdf). The characteristics of control groups in studies which report physical function (either Karnofsky scale or PF/SF-36) seem mixed. Physical function was assessed at medium term followup too (I corrected my post above), here are the temporal definitions: "Outcomes were classified as post treatment, short term followup (1-6 months post-treatment), medium term follow-up (7-12 months post-treatment) and long term (longer than 12 months)."

    Also I forgot to mention that while the 40% vs 26% clinical response figure is for post-treatment with fatigue as a primary measure, the difference becomes non-significant at short term follow up (3 studies, 353 participants). So in other words the effect seems brief, you couldn't ever tell that from Chalder's statement on the Cochrane review.

    This is what the authors had to say:

    The authors view the conclusions as "very preliminary findings" and state that there is a "surprising lack of high quality evidence" and note the unknown degree of response bias and poor reporting of adverse effects. Cochrane actually shows that the state of evidence for CBT in 2008 was very limited and relatively weak. Compare that to proponents who viewed CBT in 2008 as a wonderful and established treatment with mountains of unquestionable evidence. You're probably right that PACE was generally better conducted than these studies.

    Hi Alex, I've come across many such things when reviewing the literature, so I think you are onto something important and I hope you manage to write something on it, I would be interested in reading it. The evidence doesn't support their cognitive behavioural hypothesis of CFS as a primary explanation for the symptoms and disability of ME, at most it may have limited explanatory power in a minority of patients. Even that may be generous as the nature of the correlations are unclear. I have come to see the gyroscope as a symbol of the cognitive behavioural approach to ME/CFS because it has kept itself upright due to ongoing spin and would soon crash without it.
    WillowJ, Snow Leopard and oceanblue like this.
  18. oceanblue

    oceanblue Senior Member

    Messages:
    1,174
    Likes:
    343
    UK
    Thanks, that's very helpful, and more damning than I remembered. So, that really leaves us with PACE for evidence on CBT (&GET). It's a busted flush, basically.
  19. alex3619

    alex3619 Senior Member

    Messages:
    7,185
    Likes:
    11,254
    Logan, Queensland, Australia
    Lol biophile, the gyroscope theory of CF? Maybe it should be their logo. Bye, Alex
  20. Snow Leopard

    Snow Leopard Senior Member

    Messages:
    2,302
    Likes:
    1,766
    Australia
    Re: the Cochrane review, I'm having trouble finding the 'improvement over 12 months' employment data from 'Sharpe 1993'.

See more popular forum discussions.

Share This Page