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ME/CFS: A disease at war with itself
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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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    Free full text:
    http://qjmed.oxfordjournals.org/content/early/2013/03/28/qjmed.hct061.full
    pdf- http://qjmed.oxfordjournals.org/content/early/2013/03/28/qjmed.hct061.full.pdf html

    (The comparison trial is the PACE Trial)


    *I gave each sentence its own paragraph
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  2. Dolphin

    Dolphin Senior Member

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    This journal takes letters if anyone wants to reply:
  3. Simon

    Simon

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    Comparison is vs baseline (no control group), on a par with PACE Trial SMC group
    Note that these figures are a before/after comparison, with no control group to allow for any natural improvement or placebo effect. This study uses the same Fatigue and Physical Function measures as the PACE trial, and the patients in this study did about as well as the SMC group ("specialised" medical care, no CBT or GET), and less well than the PACE CBT/GET patients who had the same treatments.

    This study vs PACE SMC, baseline to 12 months
    Fatigue: -6.8 vs -4.5 (ie improved more* than PACE SMC)
    Physical Function: +4.4 vs +11.6 (ie improved less* than PACE SMC)

    *Physical Function difference between this study and PACE is almost certainly statistically significant due to the very large sample sizes, though the difference in fatigue might not be.

    This suggests that 'out in the wild', CBT and GET (and any othr treatment offered) are, overall, no better than SMC.
    sianrecovery, wdb, Svenja and 2 others like this.
  4. maryb

    maryb iherb code TAK122

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    Thanks to those with a scientific bent for explaining things for us 'foggies'
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  5. Dolphin

    Dolphin Senior Member

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    Minor point:
    A possible corollary of this is that services that use the criterion that fatigue must be the most significant symptom, like Barts, and indeed trials like the PACE Trial, might (at least marginally) help get better results for themselves as it would have the effect of the pain levels of their patients being a bit lower on average.
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  6. Dolphin

    Dolphin Senior Member

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    This presumably helps isolate the services involved:
    (my bolding)
    Does this mean Dr. Murphy would cover two services?

    3 services used CBT/GET and three activity management.

    Can we work out which ones are which?

    Barts would be CBT/GET.
    I think Dr Hazel O’Dowd (North Bristol NHS Trust) would be also.

    I think Sue Pemberton (Leeds and York Partnership NHS Foundation Trust) uses activity management.
    I imagine Dr Yasmin Mullick and Dr Amolak Bansal (Epsom and St Helier University Hospitals NHS Trust) do too.

    Barts is a large service. The paper says something about one large service offering CBT/GET and one offering activity management. I imagine the CBT/GET one is thus Barts? And the large activity management one would be which one?
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  7. Dolphin

    Dolphin Senior Member

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    Figure 1.
    is

    Here is some info on this:
    Afraid I don't really understand polynomial generalized estimating equation (GEE) regression models of fatigue but believe I have an idea what they did.

    Judging by the shapes of the graphs, the lowest point (best value) for fatigue was at around six months and scores then actually gradually got worse (graph is cut off at 600 days). I wonder does this mean that rather than patients improving with time, patients actually were regressing a little on average?
    (This isn't discussed explicitly in the paper, only that points between 8 months and 20 months were considered comparable to scores at 12 months).
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  8. Dolphin

    Dolphin Senior Member

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    In Table 3:

    and
    Table 5:

    I think, although am not 100% sure, it should be <0.
  9. Esther12

    Esther12 Senior Member

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    I just stumbled over this old thread on outcome measures from these clinics, and thought I would post:
    Report from CCRNC for APPG inquiry into patient services (2009)


    http://forums.phoenixrising.me/inde...-into-patient-services-2009.8177/#post-157348

    Dolphin picked this out as the most interesting and complete data at the time:

    There's also plenty there to indicate that 'activity management' can be quite different from the CBT/GET approach.
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  10. Dolphin

    Dolphin Senior Member

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    Thanks Esther12.

    I just checked and this error is in the original. First number should be 9.9.
  11. Dolphin

    Dolphin Senior Member

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    Good point. This paper makes out it is based on CBT/GET, because "activity management" in the NICE guidelines are. However that's not necessarily what services are using if they're not using CBT/GET.
  12. seanpaul

    seanpaul

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    We did not find that depression, anxiety or duration of illness at assessment predicted outcome. Clinicians providing assessments should not assume that co-morbid mood disorders or length of illness are predictors of outcome.

    White puts his name to this paper - no doubt just to get his name on another paper, with this being Crawley's work *which goes to show the absolute lack of independence in UK ME/CFS research, whereby they state there is no connection between depression and anxiety and outcomes, yet White has pushed many papers saying the absolute opposite, the ME is a psychiatric illness highly correlated and predicted by depression and anxiety.

    Inconsistency again and again - using the same old psychiatric derived survey instruments
    Bob likes this.
  13. Dolphin

    Dolphin Senior Member

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    Good points.

    I think a reason Peter White's name may be on it is he/Barts were part of those given research money by Action for ME to assess the services (it was a joint application to AfME headed by Esther Crawley but also mentioned Barts - I didn't think it was the safest or best use of such research funds).

    Here is one fairly recent paper where they make an issue out of depression and anxiety: http://forums.phoenixrising.me/index.php?threads/cognitions-behaviours-and-co-morbid-psychiatric-diagnoses-in-patients-with-chronic-fatigue-syndrome.22402/

  14. Simon

    Simon

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    based on my googling, plus your comments:

    CBT/GET
    - Barts
    - East London
    - Bristol

    Would have thought that Bart's was the biggest, but an AfME interview with Hazel O'Dowd(not sure of date of it) says now seeing 400 pa: the three CBT/GET services in this study saw 372, 160 & 157 patients in 2010
    "Activity Management"
    - Leeds/York
    Sue Pemberton, consultant OT, was replaced last year and has set up a private service - the Leeds/York service now run by consultant liaison psychiatrist Dr Hiroko Agaki so think it now does CBT/GET. From her statement it seems likely that Leeds was the big Activity Management centre since it's long established and has played a lead role:
    That would leave:
    - Somerset
    - Epsom & St Hellier

    However, I'm not sure how clear-cut the distinction between CBT/GET and Activity Management really is in practice: CBT uses activity management and all the 'activity managment' centres use psychologists in the mix, though I don't know if Leeds did during the time of this study (2005-9).
  15. Dolphin

    Dolphin Senior Member

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    Thanks.
    I've remembered now that Barts supplied two centres for the PACE Trial (seems slightly odd to me that it was called two centres, but maybe the sample sizes of all the other centres were all fairly similar), which suggests it's big centre.

    Anyway, it looks like one out of Barts and Bristol had quite poor results. It would be interesting to be more sure. "Barts/PDW" strut around, in a way, as if their service is great.
  16. Simon

    Simon

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    Some thoughts on the paper:

    Read the small print first - it matters
    • This isn't a clinical trial, instead it uses data from everyday clinical practice, which is a whole lot more messy and harder to control
    • Only just over half of all patients completed outcome questionnaires, eg fatigue scores. Although those that completed questionnaires were demographically very similar to those that didn't, as the authors say "we don't know whether patients lost to follow-up had better, the same or worse outcomes at 8-20 months, or how any such differential losses might affect results"
    • All comparisons are between outcomes and baseline, not versus a control 'untreated' group. Some of the improvement is likely to be due to natural recovery, or placebo effect, or self-report bias.
    • Nonetheless, this much better data than most NHS clincial services collect, and I think, still useful - though findings are not hard and fast. They also cover over 800 patients.
    Overall results: "mixed"
    • Both fatigue and function improved in patients from baseline to outcome (which varied from 8-20 months). The improvement in fatigue was a drop in the Chalder Fatigue Scale score of 6.8 points, similar to that seen in the PACE trial for CBT/GET (compared with baseline). This is on a 0-33 scale, but 11 is 'normal' and 33 is worst, so it's effectively a 22 point scale, and a 6.8 point improvement is substantial.
    • However, Physical Function only improved by 4.4 points (0-100 scale), much less that the +11.6 improvement from baseline of the PACE SMC 'control' group.
    • Overall, then, there was a substantial improvement in fatigue and nothing much to report in function - the resutls for function were far worse than reported in the PACE trial (+19 points gain for CBT/GET)
    • Results in clincial practice almost always fall short of trials, and not just in CFS. In trials, patients and therapists are likely to be more motivated, there are more resources, standards of therapy are monitored, compliance rates are higher, trials usually have more sessons etc. 'Non-ideal' patients, eg those with additional illnesses are usually excluded from trials. That said, what matters to patients is the effectiveness of the treatment they are likely to receive themselves, and this study is likely to give a better indication than a clinical trial.
    cont next post
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  17. Simon

    Simon

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    Activity Management vs CBT/GET

    In some ways, this is a bombshell:
    2 points is huge, given that much of the improvement in baseline is probably self-report/placebo/natural recovery. CBT/GET in PACE only achieved a gain of 3.5 vs SMC. And particularly given that in PACE APT (pacing) came out worse than CBT/GET.

    On the other hand, this is comparing 3 services with 3 other services, and there could be many, many confounding factors linked to the particular services inc type of patients (though many baseline factors were adjusted for) and number of sessions, plus group vs individual treatment.

    On top of this, looking at clinic websites there seems to be a lot of overlap between CBT/GET and activity management with OTs, physios, psychologists involved in both types of services, and pacing common to all, at least to some extent. Looks to me more like a spectrum of treatments rather than a clear CBT/GET vs Activity Management divide.

    The authors argue all this, and I think they have a point. Nonetheless, these results don't support the view that CBT/GET is superior to activity management.

    Also, note this:
    Anxiety, Depression, Illness Duration etc: nothing much predicts response to treatment
    • Anxiety and depression at baseline were NOT predictors of outcome so if you had anxiety or depression you would respond the same to treatment as those that did not.
    • Illness duration at baseline was NOT a predictor of outcome, which is slightly surprisingly: it was generally thought that chances of recovery are much better in the first years of the illnes, though this is the biggest data set I've seen looking at outcomes so the findings may well be right.
    • Worse physical outcome at baseline was associated with a slightly less improvement in fatigue. Other effects, eg worse pain at baseline predicitng slighly less improvement in Depressioin were very small, and probably only statistically significant because of the huge sample size.

    Other points
    • Progress seems to flatline after 6 months or so, similar to PACE. Looks like there might even be a slight decline but prob not statistically signficant (and note there seem to have been quite a lot fewer sessions per patient than for PACE). Nonetheless, if CBT/GET theories are right, it should be 'onwards and upwards', not flatlining well short of recovery. On the other hand, this is the kind of pattern you might expect from a modestly helpful illness management programme.
    • All of the outcome measures in the study were self-reports and as such may be prone to some self-report bias. Ideally objective measures are needed too eg actometers (to measure activity levels), employment levels, benefit levels etc. Where these have been measured in other trials and studies (eg PACE, Wiborg studies, Belgian Audit of CFS services) objective gains have not materialised. However, this ongoing study is now collecting data on school attendance and impact of ill-health on work, so hopefully this will be addressed in future reports.
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  18. Esther12

    Esther12 Senior Member

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    Thanks a lot for that Simon.

    re school attendance being measured in the future: I suspect that this is an outcome measure which could be dramatically improved without one needing to improve patient's health. Generally though, the 'CFS in kids' stuff I've seen seems even less good than the adult stuff, and it's quite possible that a lot of kids given this diagnosis have quite different problems than those found in adults. And things like viral triggers for CFS would be totally different, due to differences in kid's immune responses (no glandular fever!).

    re the number of patients looked at: do you think that these represent all of the patients going through these clinics? I had assumed that clinics would get though more patients than this, but I don't really know what it's sensible to assume.

    It looks like this BACME report covers the same period (up to 2009). It seems to show pretty variable results from different services, and looked at data more than six services. I wonder how they choose which ones were put in to this new report? I'd love to get my hands on all the raw data, and information about which centre was which.

    http://www.bacme.info/document_uploads/BACME_docs/ReportAPPGFINAL.pdf

    From page 16, patient reports seem to indicate that there is a significant role for 'pacing':

    This isn't 'recovery' style CBT:

    I'd like to know how they selected patient comments.

    The report also says:



    Is it really a high response rate? I'd assumed that many more patients per year were being 'treated' than this. I don't think that they ever said what the response rate was either.
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  19. Simon

    Simon

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    Thanks.

    I think generally in clinical practice, and probably in the PACE trial too, CBT isn't 'recovery' style - I suspect that many therapists are pragmatic and recognise the limitations faced by patients; certainly PACE results indicated that if they used 'recovery style' CBT it didn't work as such.

    Response rate was 53% for fatigue outcomes, 50% with all outcomes. That's lousy by trial standards, but probably pretty good for clinical practice. The paper says they only included clinics with >40% response rates so excluded clinics were all less than this.
  20. Esther12

    Esther12 Senior Member

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    re CBT types: But then they'll talk as if the different CBT trials are all testing the same thing! Treating all CBT approaches to CFS as if they're the same is like assuming all drugs are the same: "Drugs are an evidence based treatment shown to improve symptoms." A failure to explicitly distinguish between them also makes it difficult for patients to give informed consent.

    re PACE CBT: There is something from the/a PACE trial PI lumping their CBT with 'recovery style' CBT, and away from Friedberg 'learn to live with' CBT. I can't remember the quote or where it was from though. I could probably dig it up if you wanted.

    re Response rates: I may not have been clear, but everything I was quoting from from the older report where they did not provide the response rate.

    re the response rate for this paper being over 40%: Do you think that is of all patients seen, or of all patients asked to fill in questionnaires?

    I'd guess that the response rate was for all patients, but that different services started using the questionnaires at different times.

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