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Treatment outcome in adults with CFS: a prospectiv​e study in England based on the CFS/ME NOD

Discussion in 'Latest ME/CFS Research' started by Dolphin, Mar 30, 2013.

  1. Dolphin

    Dolphin Senior Member

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    Another example of this is the talk that CBT is used in certain conditions, so people with ME shouldn't be offended/similar. The content of CBT in other conditions is often very different (as well as the fact that it is often not a frontline therapy for everyone, etc.).
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  2. Esther12

    Esther12 Senior Member

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    Yeah - it is a weird argument. Also, the claims the CBT is a genuinely useful treatment for all these other patients seems pretty questionable to me. It all seems a bit CAM - people report finding homeopathy useful for all sorts of stuff... that's one indication that it's just placebo. Some people like feeling cared for, even if it's being done by quacks, and will tend to fill in questionnaires positively about their 'treatment'. Other people hate being treated like that.

    Here's an lengthy list of things CBT can 'treat', including "Aging".

    http://www.beckinstitute.org/cognitive-therapy-can-treat/

    CBT promoters are not lacking in confidence.
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  3. Simon

    Simon

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    That was a reason given by PACE for manualising their therapy approaches, along with checking sessions for compliance to manual - and their conclusion was explicitly about CBT/GET as manualised. I imagine they would argue one reason the NOD results aren't so good is that they aren't doing CBT/GET 'right'.

    However, as you say, CBT was more 'Recovery' style (makes it sound like a psy gangnam-derivative) and clearly most Trial patients didn't respond that well. So I'd be very interested to know what actually happened in therapy sessions when patients had failed to improve as the therapist (and no doubt patient) hoped. Given the high levels of patients satisfaction, as well as the high ratings for patient-therapist alliance, I'm guessing patients were not berated for failing to deliver and there was a pragmatic acceptance of limitations.

    Yes, the usual examples quoted are things like cancer, where it's a managment/coping technique, whereas more is often claimed for CFS for CBT.

    But Beck is hardly an unbiased source... Think there are some Cochrane reviews showing strong effects for CBT in some areas (depression, anxiety?), but not in others. I have this vague feeling some of the depression findings have been challenged, but not sure about that.

    However, for CFS all that matters is whether or not CBT works for CFS. That's why I like studies like the NOD one, which reports real-world results: significant fatigue improvement reported [edit: some of which is probably due to natural recovery, self-report bias unknown], not much in the way of physical function. Longer-term, the real measure of success needs to be objective functional improvements eg fatigue improving enough for people to move off benefits and return to work.
  4. Dolphin

    Dolphin Senior Member

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    Just finishing up my notes on the paper:
    This data in this paper has another reason to be of interest to those interested in the PACE Trial.
    It was speculated previously that the SDs of fatigue and the SF-36 physical functioning scale were artificially small because of the entry requirements.

    This was important because, in the PACE Trial:
    In the services, the SD of the CFQ was 5.2 and 22.7 for the SF-36 PF. This means the SDs were larger, as predicted. Using 0.5SD of these SDs would have given smaller percentages improved for the PACE Trial.

    In this current paper, they also used the same formula:
    Oddly, they said this was 2 points on the CFQ.

    It is not discussed why it is not 3. It is not the case that they uniformly round down, three of the four legs of the trial had SDs less than 4, meaning the average for the total would have been less than four.

    The results section is then confusing on this:
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  5. Bob

    Bob

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  6. Bob

    Bob

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    I haven't quite got around to reading this paper, or the thread, in detail, but I wonder if anyone has any insight into whether the results from the NOD should be compared directly to treatment plus control (CBT+SMC and GET+SMC) in the PACE trial? (Rather than the additional effects of CBT or GET.)
  7. Bob

    Bob

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    I've transfered this over from the other thread to keep the discussions of the original paper in one place...

    I'm not certain if a direct comparison can be made to the PACE trial, but I think if a comparison is made with the PACE trial results, then it would be with the treatment plus the control.

    In which case, perhaps the above data would indicate a lower improvement rate than the results of CBT/GET in the PACE trial.

    The PACE trial had a 76% improvement rate for CBT+SMC for Chalder fatigue, and an 80% improvement rate for GET+SMC for Chalder fatigue.

    That compares to 71% for CBT+SMC and 70% for GET+SMC in the PACE trial, for SF-36 PF.

    That compares to 59% for CBT+SMC and 61% for GET+SMC, for improvement on both scales in the PACE trial.
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  8. biophile

    biophile Places I'd rather be.

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    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3665909

    It is somewhat confusing which thresholds were actually used:

    As Dolphin pointed out earlier, the nearest whole number for 0.5SD of baseline score (i.e. 5.2) is 3 not 2. Furthermore, they later use the > symbol which should mean "greater than":

    * The 22 is a typo, it should be 11.

    Usage of the ">" symbol makes me wonder what thresholds were actually used, did the NOD study have a higher threshold than PACE for clinical improvement due to higher baseline SDs, i.e. >2 or >=3 points in fatigue compared to PACE's >=2 points, and >11 or >=12 points in physical function compared to PACE's >=8 points?

    If so, it may help to partly explain some of the difference in 'response' rates, but it still does nothing to explain the much lower group average improvements in physical function score. Irrespective of the above confusion, when the range for the physical function score is 0-100, the scale is in 5 point increments, so an individual cannot score 8 points (PACE) or 11 or 12 points (NOD), but must score 10 points (PACE) or 15 points (NOD) to reach the threshold.

    So it would appear that the NOD threshold for an individual clinical response in physical function (>=15 points) was higher than the PACE equivalent of >=10 points. Again, this does not explain the much less improvement in physical function score for NOD than for PACE.

    The reported baseline scores were very similar between NOD and PACE, but the NOD study lost half of the patients to follow-up and had no natural course control group or a SMC-alone group. Bob. I agree that a direct comparison cannot be reliably be made to the PACE Trial, but if a comparison is made, then it would be with the treatment plus the control.

    However, just as it seems plausible that the application of CBT/GET in NOD was not as good as in PACE, it also seems plausible that the equivalent of SMC (if given at all) was also not as good. The efficacy-effectiveness gap between RCTs and routine clinical practice is a well-known phenomenon and there is evidence this applies here as well. The patient population and staff competence and quality control are often different between these two settings.
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  9. Dolphin

    Dolphin Senior Member

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  10. Bob

    Bob

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    I've read most of it now, and thought I'd make some comments while they are fresh in my mind.

    I think this is an interesting and helpful study, and it seems to be quite well conducted, even if I don't like the way some of the discussion is framed.


    I think this is a helpful observation in the paper. It's a discussion we've had relating to the PACE trial:

    Discussing possible reasons for disparities between outcomes of NHS and PACE, the paper says:
    If they are aware of this, it makes one wonder why they didn't include a waiting list placebo control in the 'gold standard' PACE trial to take account of these factors.


    Now to some figures...

    The following passages suggests that they did compare the NHS treatments with the intervention plus control in the PACE trial, when looking at average improvements:

    They say that there is a moderate effect size for Chalder fatigue, and the following extract suggests that NHS treatments are not moderately effective for physical function, in which case they are not getting clinically useful outcomes (as per NHS policy, as far as I understand the NHS) for physical function:


    Edit 2 (After further thinking, I may have made errors, and have deleted the erroneous info.)
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  11. Bob

    Bob

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    Are you certain about this Simon? I can't find the details. Do you think you might have made a mistake here, based on the following?:
    i.e. they chose the clinics with data for >40% of patients at 12 month follow-up.
  12. Simon

    Simon

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    Ah, I can see that was confusing: I meant >40% response rate to the outcome questionnaire, not to treatment!
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  13. Firestormm

    Firestormm Guest

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    Simon Morning :) Out of interest - and further to your previous comment about 'bombshell' - does the paper define 'activity management'? Thanks.
  14. Bob

    Bob

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    No, it says that they did not have specific details about any of the NHS treatments.

    "As treatment content and adherence were not assessed, it is not known whether CBT or GET conformed to existing protocols or whether activity management provided content consistent with CBT or GET principles."

    "NHS specialist CFS/ME services in England follow National Institute for Health and Clinical Excellence (NICE) guidelines, offering CBT or GET, or components of CBT or GET alone or with activity management and sleep management.3 For severely affected patients, the guidelines recommend an activity management programme that draws on the principles of CBT and GET."
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  15. Bob

    Bob

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    After further thinking, I think I got some details incorrect in my earlier post. I've deleted the erroneous details.
    I now think that they were possibly correct to say that NHS treatments were moderately effective for Chalder fatigue.
    It would be correct if there was no significant difference between NHS treatment and CBT+SMC or GET+SMC in the PACE trial.

    Although, as the paper says:
    "The lack of patient-level treatment data and a non-intervention group does not allow us to compare treatments or to determine whether observed improvements were due to the interventions themselves."

    Here's a comparison of the improvements...

    NOD Chalder fatigue: -6.8

    PACE Chalder fatigue:
    SMC 4.5
    CBT 3.4
    GET 3.2
    CBT+SMC 7.4
    GET+SMC 7.6
  16. Bob

    Bob

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    Yes, unfortunately he's made a mistake there, hasn't he.
    I wonder if he got confused from the way the graphs are laid out online.
    I've just been looking at Table 4, and I got confused because, at the top it says: "Treatment outcome in adults with chronic fatigue syndrome...", but that's the title of the paper, not the Table.
    http://qjmed.oxfordjournals.org/content/early/2013/03/28/qjmed.hct061/T4.expansion.html
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  17. Firestormm

    Firestormm Guest

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    Thanks. And we also don't know if each clinic, and each therapist/whoever, was following the same approach either I presume? I mean it's unlikely it was a la PACE i.e. from out of a manual, is it? Given that clinics are meant to be personalising etc. Also I am unclear about the way in which data was collected (other than presumed use of questionnaires). NOD/Clinical settings like to use 'personal goal-setting' as a means of measuring success - but it's not clear if this was part of the study here: probably not. Which is a shame in a way - although again hard to generalise and everyone's goals are different and as you are able to change your goals should the initial ones prove irrelevant etc. I like the idea of NOD but it's only really going to work with a standardised treatment package: which is not something patient want.
  18. Bob

    Bob

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  19. Bob

    Bob

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    An authors' correction note has been published.
    It doesn't change anything substantial or the conclusions....
    Just a few details...

    Authors' Correction Note:
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3870018/

    PDF:
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3870018/pdf/hct122.pdf


    Below, I'll post the original text, in relation to correction no. 2, and what they now say it should have read, as I understand it:

    The original text was as follows:
    "About 74% (620 of 834) of patients had a decreased Chalder Fatigue score at follow-up and 64% (534 of 834) had improved by >2 points (our definition of a clinically useful improvement). In contrast, only 50% (416 of 834) of patients had an increased SF-36 physical function score at follow-up and only 16% (131 of 834) had improved by >22 points. In total, 14% (120 of 834) had clinically useful improvements on both scales."

    And I think it should have read as follows:
    "About 74% (620 of 834) of patients had a decreased Chalder Fatigue score at follow-up and 64% (534 of 834) had improved by >2 points (our definition of a clinically useful improvement). In contrast, only 50% (416 of 834) of patients had an increased SF-36 physical function score at follow-up and only 29% (### of 834) had improved by >11 points. In total, 25% (### of 834) had clinically useful improvements on both scales."
    Last edited: Feb 18, 2014
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  20. Bob

    Bob

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    An interesting thought that I've just had...
    If there was no significant overall improvement in physical function, and yet 50% of patients had an increased SF-36 PF score, then this must surely mean that up to 50% experienced a deterioration? But perhaps not quite this high if there was some (non-significant) improvement in overall physical function. This is quite damning, and surely puts to rest any claims that CBT/GET are not harmful. And it supports the results of the patient surveys. I don't recall any discussion of deterioration in the paper (but no surprise there!)
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