This follows on from my previous post on Prof Peter White’s new GETSET study: Do GET Yourself…
The star of the GETSET guide is ‘Julie’, a (presumably) fictitious patient who valiantly adjusts her activity diary to ‘stabilise’ her schedule so that she is doing a similar amount of activity every day. Julie has already become a favourite with online patients who are impressed with her remarkable level of activity for someone with CFS/ME. She now has her own Twitter account and according to her profile picture wears a Wonder Woman suit.
This is scarcely surprising, as before commencing therapy she was working five days a week, walking to work and back two or three times a week, attending a weekly yoga class, and going out with friends on Thursday and Saturday evenings. In spite of all of which, she sought medical help for CFS/ME.
I suppose we have to assume she is a typical patient of Prof White’s. Why, after all, would he choose to use a diary from an untypical patient? So once again we are left wondering what illness we are dealing with here?
Julie’s attempt to stabilise her diary is also interesting. From my experience of my own local NHS clinic, which used to be one of the better ones, setting a baseline level of activity for their own rather more patient-driven strategy usually entailed cutting back considerably on the total level of activity, partly by lowering standards on things like housework.
By contrast, the remarkable Julie was able to stabilise her week’s activity by fitting in an extra hour-long study period, trebling her hour-long reading sessions from two to six, introducing three hours of housework (which she had previously neglected entirely), spending an hour phoning round her friends (again previously neglected), going out for Sunday lunch, and even cramming in five extra hours of TV – all this at the same time as keeping up her two nights out a week, her yoga class and her thirty-five hours at work – though the latter now included three ten minute rest periods a day (so it’s good to see some pacing going on).
Presumably work were ok with these rests, though it does stand out as a possible example of the clinics expecting more cooperation from employers then they’re actually prepared to give. Nevertheless it is quite a feat, this ‘stabilisation’ of Julie’s; you have to wonder how she does it. Has she overturned the laws of mathematics?
Not quite, though the answer is Wonder Woman-like enough. She does it by taking twenty-one hours less sleep a week.
That’s right. You heard it. Twenty-one hours less sleep. That’s the equivalent of three hours less a night. All that neglecting housework was obviously making her dozy. Now she’s stabilised and doing all the extra stuff in an orderly manner, she no longer needs so much sleep.
And how long does this massive change take her: adding in three hours of housework, extra study and reading, extra time for friends, plus cutting out twenty-one hours of sleep etc etc? The guide warns ‘it may take a week or longer’.
Well, Rome wasn’t built in a day, but I suspect Prof White might have wanted it finished by the weekend.
On top of all this, Julie has to add in some stretches, and then some favourite exercise (on top of the three hours of housework she’s just introduced) and then increase the amount of exercise by ‘no more than’ 20% a week.
The guide advises:
You may find that at the beginning of a week when you have increased your exercise time that you experience some stiffness or fatigue. Do not worry – this is a normal response to increased activity. If you continue with your exercise, and do not cut back or add any other physical activities, your body will adapt.
Thank goodness for those adaptable bodies of ours. We’d be in a pickle without them, wouldn’t we?
Seriously, though, the more you read this stuff, the more you think they must be talking about something other than ME. Yes, many of us struggled on at work for ages, dragging ourselves around, but we didn’t manage two nights out a week and a yoga class as well. And if we stabilised to what we could readily cope with every week, we wouldn’t be adding in extra studying and housework thank you very much.
It seems obvious that this plan was not written by someone with ME, nor by someone who had ever listened to anyone with ME (not really listened). Even the grading of the different activities (into high, moderate, and low level activities and rest/sleep) is a nonsense.
OK, walking, shopping and yoga are classed as high, which is accurate enough; but working itself is classed as moderate, as is housework (which any ME patient knows is strenuous exercise). Showering is classed as low level, but this is also strenuous and can be a landmark activity. For many people with ME, it is all they can do in a day. Talking with friends on the phone can also be strenuous in its way. It is not ‘low level’ for most of us.
So are they really dealing with ME or with other forms of chronic fatigue?
The NICE criteria were used for the study. These were never intended for use in research and are unduly inclusive, as with Fukuda. They are only a little better than the much derided Oxford criteria. They require fatigue with (arguably) post exertional malaise but unless this is carefully defined, it can gather in all and sundry. Many other typical ME symptoms are mentioned in the NICE definition but only one of them is required. So we could be talking about a sample of patients most of whom do not have ME but some other form of chronic fatigue: a whole brigade of Julie’s.
This may indeed be the case because one of the exclusion criteria for the trial is ‘contraindications to exercise’, So really any patients with genuine ME should have been excluded from the sample. Research such as that by Prof Mark VanNess has shown that we have an abnormal response to exercise, while the US Institutes of Medicine suggested that ME should be renamed Systemic Exertion Intolerance Disease to describe the condition in terms of this essential characteristic. So ‘contraindications to exercise’ should certainly apply to us.
Indeed, patients have long suspected that many people with genuine ME have been excluded from exercise therapy trials (and also, incidentally, from NHS clinics) because it was clear they were too ill to respond well to the ‘treatment’ on offer. The trouble is such trials are nevertheless presented as relating to CFS/ME – or even just to ME – so that what may work for generic chronic fatigue is assumed to also work for what is an entirely different, much more serious, condition.
None of what I’m saying here is exactly groundbreaking and if I don’t get to the end of this soon one or two of you (Julie excepted of course) may be nodding off. But what I have less often heard discussed is the question of why proponents of the deconditioning (aka biopsychosocial or bps) theory do not simply accept that their ideas don’t apply to everyone?
If patients with fatigue due to depression, for instance, respond well to GET and CBT, then why not try to specifically identify such patients instead of dragging ME patients into it too? The researchers might then improve on what are quite frankly pretty mediocre results even with all the sleights of hand with the figures; they would stop getting hassle from us; and patients with ME could be finally left alone to get the rest we need. It seems to me that this would be win-win situation.
From time to time the bps researchers do this in a half-hearted way. They’ve been known to say that their research only applies to CFS, not to ME, for instance – and here in the GETSET paper, reference is only made to CFS, not to ME. But there is no consistency. The GETSET patients’ guide – in contrast to the paper – refers to CFS/ME, and when the two are conflated by reporters in the media, Prof White and his colleagues rarely if ever correct it.
So why do they insist on muddling us all together? Can they just not bear to lose us as their patients? Or could it be that they need us in some other way? Could it be that they need the presence of ME patients to make their theories appear to stand up?
Take deconditioning for instance. If you look at Julie with her five day working week, her walks, her yoga, her nights out twice a week etc, how can it be that she is deconditioned? Surely she does so much that she can’t be… But if she isn’t deconditioned, then how – according to the bps theory – can she be ill?
Maybe the researchers need the presence of some really ill people (who look like they might be deconditioned) to lend their theory some credence, to make it seem like they know what they’re talking about? Because Julie may benefit from the ‘therapy’ but she doesn’t fit the theory any better than we do.
Hmm, just thinking aloud really that last bit and it’s not really up to us patients to make sense of it all, more to point out where things don’t add up. So it may be worth summarising the blatant incongruities I’ve encountered while going through the GETSET guide one more time:
How can they claim there’s no implication that the condition is ‘caused by psychological factors’ when the treatment is based on deconditioning due to false ideation?
How can the treatment be relevant to ME if patients with contraindications to exercise are supposed to be excluded?
The GETSET paper talks about CFS and the guide about CFS/ME. Why the discrepancy?
How can a supposedly typical patient like Julie be deconditioned when she’s been working five days a week, attended yoga class, gone for walks, and had evenings out twice a week?
On top of which there are additional problems with the trial which I haven’t gone into here. These read a bit like the bps researchers’ greatest hits. They include:
- No significant improvement in physical functioning reported.
- Addition of a new primary outcome measure after the trial had started.
- All outcome measures were subjective and self-reported.
And, this being bps, there’s more as well of course. You can take a look at a detailed critique of the study from Dr Charles Shepherd of the ME Association here.
Right, Julie, it’s time for your yoga class now…
(Julie’s ‘before and after’ schedules can be found on pages 10 and 11 of the GETSET Guide.)
Following the recent release of data from Peter White’s PACE trial (by order of a Freedom of Information tribunal, £250,000 having been spent in attempting to stop it) PACE has finally been revealed as the travesty of the truth it always has been. Rather than give the appropriate heartfelt apology, however, Prof White continues in denial.
The blog to which he disparagingly refers was written by patients who have used energy they can ill afford to spend in a David-and-Goliath struggle to reveal the truth about this reprehensible study. With the aid of expert statisticians they have not distorted the figures, as Prof White implies. What they have done is to use the newly released data to analyse the results in line with the trial’s original protocol, which White and his fellow authors originally declared they would use but then changed their minds as it didn’t give them the outcomes they wanted. They never gave a satisfactory explanation for this change but it now seems pretty obvious why it happened. The newly reanalysed results show that GET and CBT are of no more use than a placebo. They are worthless for ME/CFS, but White and his associates refuse to admit it as they have built their life’s work on these therapies. Therapies which, moreover, have been shown to be harmful for patients with ME/CFS in numerous surveys. Patients have ended up housebound or bedbound for years on end because of the efforts of White & Co, but still they refuse to admit they have done anything wrong.
This change of protocol was only the tip of the iceberg in terms of the study’s shortcomings. The Criteria used to select subjects for the study included patients with other fatigue conditions; the numerous changes in protocol meant that patients could be ill enough to join the study, deteriorate during it, yet still be classed as ‘recovered’ at the end; objective outcome measures which actually measured patients’ abilities were abandoned in favour of questionnaires; conflicts of interest on the part of the investigators were not disclosed to study participants, the list goes on and on…. In years to come, PACE will be used as an example of how NOT to conduct a research study.