Will CBT/GET proponents 'call a halt without loss of face'?
Dolphin wrote: Here is an extract from the Barts CF service submission on the draft NICE guidelines: [...] These goals should include recovery, not just exercise and activity goals. If it takes "years" to achieve goals, then either the goals are wrong or the therapy is wrong. What other treatment in medicine would take years to work? We suggest "or even years" is deleted. If a therapy is not helping within a few months, either the therapy or the diagnosis or both should be reviewed and changes considered. We suggest that this advice is pertinent to all treatment approaches, not just for GET.
Good find. Here is a URL (
http://www.nice.org.uk/nicemedia/live/11630/36186/36186.pdf) and page number (p308) for anyone who wishes to reference that quote.
Angela Kennedy wrote: It throws up more and more questions about the cohort, and the treatment they received (ad hoc anti-depressants etc.) As you know- I think there was a key exclusion of neurological 'ME' sufferers (and the lack of 'seriously affected' goes some way to explaining this, possibly). There appears to be a high amount of psychiatric disorder cases selected in (if one looks at the 'SCID' it becomes clear the trial allowed for this). But WHATEVER the conditions of the cohort, the objective 6MWD WAS shockingly poor! WHY was that? Is the question I guess. WHAT was going on with that cohort?
Dolphin wrote: Peter White always seems so sure of himself to me when, if he was really aware that the statistics could be looked at in another way, he should have more doubts.
oceanblue wrote: There's an extraordinary contrast between the progress anticipated by the GET manuals (or the Bart's NICE submission - 2007?) and the paltry 6MWT gains for PACE GET. Surely they were genuinely expecting great things from PACE and the feeble trial results must have been quite a blow. I may be projecting here, but it seems to me the authors have now talked themselves into believing the PACE results were actually quite good, rather than simply spinning the results to hide their embarrassment.
Sean wrote: Compare and contrast to the clear and early ceiling effect in the PACE study, where the bulk of the very modest 'therapeutic gains' occurred in the first 12 weeks, then tapered right off, leaving patients still worse off than most serious cardio-pulmonary patients. Nothing approaching genuine recovery there. Not even a partial recovery. Not. Even. Close. If the barely clinically significant 6WMT test result for GET is the best they have from PACE, then they have blown it.
Graham wrote: But in reality that is how it goes with most scientific and medical re-evaluations. The old school spend ages trying ever desperate ways of fitting their outmoded ideas into the new data in an effort to deter a new look at the situation. [...] I think there is getting to be a strong note of desperation in their approach now.
We know how minimal or transitory or subjective the effects of CBT/GET are when examined in previous systematic reviews. Whereas I think the PACE Trial authors may have been caught off guard by their own beliefs and expectations and blindspots. It is difficult to say what they truly expected, on one hand it seems they hoped for a lot, on the other hand they watered down the goalposts over time and avoided using actigraphy which would have been an embarrassment. They are often cautious in what they say and do, but apparently White unofficially boasted a 25% cure rate to Klimas, and White was a co-author of Knoop et al 2007 (
http://www.cfids-cab.org/rc/Knoop-1.pdf), an uncontrolled study which reported a 23% "full recovery" rate and 69% "no longer met the CDC criteria for CFS". This paper may provide clues into the anticipated PACE Trial recovery paper.
The average 6MWD for a healthy population is about 600-700m. Assuming 28% of PACE Trial participants in the adjunctive GET group were within "normal" range for fatigue and physical function, the average 6MWD should be much higher than the 379m after a year of exercise and the clinically insignificant 35.3m (adjusted) or a rough 10% advantage over SMC-alone. Not to mention that the 6MWD isn't really an objective test for physical capacity. Also telling is how 30% of the adjunctive CBT group were allegedly within "normal" range for fatigue and physical function too, with this figure being paraded in the news coverage, yet this group's average 6MWD was just as appalling as the SMC-alone group! Although the 6MWD was disappointing, perhaps they felt it necessarily to include at least one such measurement to avoid criticism of having no such measurements.
As for the severely affected, on p24 of the PACE GET therapists' manual it acknowledges that the more severely affected group has been generally excluded from research but then it immediately goes on to imply without evidence that "
the deconditioning model should apply equally if not more to these patients". Hmmm, but wasn't the FINE Trial an embarrassing failure for the deconditioning model, and somehow spun positively as something like "maybe patients need a higher number of sessions from specialists, more research is needed"?
All this reminds me of Wessely's thoughts on new CFS patients, according to an article at meactionuk.org.uk: "
Many patients referred to a specialized hospital with chronic fatigue syndrome have embarked on a struggle. This may take the form of trying to find an acceptable diagnosis, or indeed, any diagnosis. One of the principal functions of therapy at this stage is to allow the patient to call a halt without loss of face. ... [M.E. patients are in] a vicious circle of increasing avoidance, inactivity and fatigue... " (
http://www.meactionuk.org.uk/wessely.html)
Well, many biopsychosocialists specializing in CFS have also embarked on a struggle. This may take the form of trying to find evidence for the cognitive behavioural model, or indeed, any biopsychosocial speculation. One of the principal challenges for CBT/GET proponents and PACE Trial authors or supporters at this stage is to allow themselves to call a halt without loss of face. They are in a vicious circle of increasing avoidance (of truly objective measurements and stricter ME/CFS criteria), goalpost shifting and spin doctoring. 
Angela Kennedy wrote: There appears to be a high amount of psychiatric disorder cases selected in (if one looks at the 'SCID' it becomes clear the trial allowed for this).
Dolphin wrote (recently): Yes, the percentages with psychiatric disorders for the SCID were high compared to other studies in the field.
Dolphin wrote (a while ago on Lawn et al 2010 -
http://www.ncbi.nlm.nih.gov/pubmed/21103120): [I don't think this is a particularly exciting study but thought I would note the following: this study used the Oxford criteria (basically 6 months of fatigue, and some exclusions). As the authors point out, a CDC study found a current rate of psychiatric disorders using the SCID of 57% (this used the empiric criteria). As Friedberg & Jason point out in their 1998 book, the SCID finds lower rates of psychiatric disorders in CFS than other screening methods such as the DIS. The figures they quote for SCID studies are: Hickie et al. (1990) 24.5%; Lloyd et al. (1990) 21% and Taylor & Jason (1998) 22%. So the rates of current psychiatric disorders in PACE Trial patients (56%) are very high.]
I had a look at this issue recently. Lawn et al 2010 examined co-morbid psychiatric disorders in 135 participants at one centre (of the six total) in the PACE Trial. All met Oxford 1991 criteria for CFS and 56% had a co-morbid psychiatric diagnosis confirmed by the SCID: 31% had a major or minor depressive episode, 11% dysthymia, 35% an anxiety disorder, 2% obsessive compulsive disorder, 6% post-traumatic stress disorder, 8% social phobia, and 15% a specific phobia. Several participants had more than one co-morbid psychiatric diagnosis, and 30% of participants were taking an antidepressant.
The PACE Trial itself also used the SCID and the Lancet PACE paper reports that overall 33% had "any depressive disorder", and 47% of participants had "any psychiatric disorder" which "included any depressive disorder and any anxiety disorder, including phobias, obsessive-compulsive disorder, and post-traumatic stress disorder." Yet on p12 the authors state that"The 47% prevalence of mood and anxiety disorders at baseline was much the same as that noted in previous trials in secondary care (
3856%).[20,23,36]"
20. Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry 1997; 154: 40814.
23. Moss-Morris R, Sharon C, Tobin R, Baldi JC. A randomized controlled graded exercise trial for chronic fatigue syndrome: outcomes and mechanisms of change. J Health Psychol 2005; 10: 24559.
36. Wearden AJ, Morriss RK, Mullis R et al. Randomised, double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome. Br J Psychiatry 1998; 172: 48590.
I haven't examined those studies to see if the SCID was used, but it would be interesting to note if CBT/GET research cohorts generally have a 2 to 3 fold prevalence in psychiatric comorbidity compared to ME/CFS patients in the wider community. Maybe Dolphin knows off hand whether the studies reporting lower SCID rates were from the community or from secondary care, rates in the latter may be naturally higher anyway. There is a paper which reported that the response to CBT was not influenced by the presence of SCID based psychiatric comorbidity (
http://bjp.rcpsych.org/cgi/content/full/187/2/184), however it used data from a CBT study where "Patients were eligible for the study if they met the US Centers for Disease Control and Prevention criteria for CFS, with the exception of the criterion requiring four of eight additional symptoms to be present."
Esther12 wrote:
That they chose to try to cover up how disappointing the PACE results were with things like their absurd definition of 'normal' has fundamentally changed the way I view those researchers. I previously thought they were wrong, caught up in the own prejudices and oblivious to the harm they were causing patients - but also trying to help, and operating in a largely honest way (other than the sorts of misrepresentations which are a pretty normal part of human life).
If that had been the case, then on getting the results from PACE the press conference would have sounded more like:
"Whoops. Looks like we made a mistake. The last two decades of encouraging patients to believe recovery was under their control, or that GET and CBT were curative, looks like that was in error. We should probably start spending research money on other areas, as we've given it our best shot, and not been able to achieve much. Sorry."
Instead, we got: "Great news! CBT and GET are able to get one third of CFS patients back to normal!! *cough-cough* (It's quite 'normal' to be crippled by severe and disabling fatigue) *couch-cough*
oceanblue wrote: That's the way I feel about it too. They did everything they could to get CBT & GET to work - fair enough - but then tried to hide the failure. I find it hard to respect researchers who have taken such a deliberately deceptive approach.
Count me in. I have also sometimes wondered if proponents of the cognitive behavioural model for CFS, emboldened by pragmatism and the supposed importance of cognitions in CFS, are willing to tell what they may perceive internally as "little white lies" in order to boost the chances of improvement for psycho>somatic illness patients even if recovery is unlikely. This may include spinning the results of any research but without outright fraud.
Dolphin wrote:
From: [Schmaling KB, Lewis DH, Fiedelak JI, Mahurin R, Buchwald DS. Single-photon emission computerized tomography and neurocognitive function in patients with chronic fatigue syndrome. Psychosom Med. 2003 Jan-Feb;65(1):129-36.]
No mention of 60 being anything like normal: "Physical functioning. The physical functioning subscale of the Medical Outcomes Study Short Form-36 (SF-36) (21) was used to evaluate physical functional status. The scores on this 10-item subscale range from 0 to 100. Persons without chronic mental or physical conditions usually score well above 80 on the scale (21)."
21. Ware JE. SF-36 Health Survey: manual and interpretation guide. Boston: The Health Institute, New England Medical Center; 1993.
Another set of scores for a matched control group (no mention of sedentary here): "As would be expected, subjects with CFS reported significantly poorer physical functioning on the SF-36 (mean = 46.67, SD = 27.75) than did healthy subjects (mean = 96.00, SD = 5.73) (t for unequal variances (15.2) = -6.74, p < .001)."
Thanks again for the additional data, this means we now have 3 CFS studies which all indicate that, when using healthy control subjects, the lower threshold for "normal" physical function according to the PACE definition (mean -1SD) should have been more like
90/100 rather than the
scandalous 60/100.
