GETSET (white) in Lancet 22/06/17

[Luther Blissett]

I am a big greasy doner and I swing around a pole every Friday and Saturday night with the sweat dripping down me. I bet you all find that dead sexy, I even have to wait around for ages sometimes and get taken home on a Night bus at 3am. Try doing all that with ME!!

@Sushi Am I allowed to ask a fellow forum member if I can lick them? The subject has never come up before on here.

 

[Dolphin]

 

[Large Donner]

@Sushi Am I allowed to ask a fellow forum member if I can lick them? The subject has never come up before on here.

I'm quite spicy cos I'm covered in chili sauce so it's totally up to you.

 

[wdb]

A couple of good BMJ rapid responses

Susan Mayor states that the GETSET trial shows that graded exercise therapy can improve fatigue and physical functioning. Due to weaknesses in the trial design, it is not actually possible to distinguish biased self-reporting ("placebo effect") from genuine improvement. Indeed, we know from previous studies that GET and CBT don't lead to improvement on objective measures of health and functioning in CFS: their effect is most consistent with a small transient placebo effect. That this study was funded and is being taken seriously is very worrying.

The title is somewhat ambitious.
The number reporting 'much better', or 'very much better' is around 13% better in the treatment group than the control group. 'May help a small minority of chronic fatigue sufferers'.

Despite the trial being ended for well over a year now, the 12 month recovery rate is not published.
This was null, for example in PACE.

This trial had no objective measurements at all, and relied on self-reports.
The trial material claimed this was a positive intervention - to not have a positive effect on the self-reports would be very, very odd.

I note Wechsler et al's [3] work on Asthma and placebo response where even faced with continuing airway restriction, patients reported getting 'better' after sham treatment, when they were unchanged. [2] Actiometers or some other actual measurement beyond questionnaires is needed.
Convincing patients to self-report an improved condition on a questionnaire is not an improvement if that is all you have done! The above study fails to convince that is not all they have done...

 

[Sushi]

@Sushi Am I allowed to ask a fellow forum member if I can lick them? The subject has never come up before on here.

Well, basically you've already asked it! Best to keep it at that as members have varying sensibilities on things like "licking!"

 

[NelliePledge]

Playing devil's advocate, because I've been in similar situations.

You're forgetting the wait time for a bus. Plus if she has to transfer, that's additional wait time.

And as you note, some bus lines are slower than others. There isn't always an alternate route, particularly if you aren't downtown.

One more item: bus unpredictability. Some employers will not tolerate tardiness to work, particularly on meeting days. It's very easy to predict to within couple minutes your arrival time when walking, whereas buses are much less reliable, particularly if you have to transfer. Perhaps the days Julie walked to work were days when she had to be there on time or risk getting fired. This was the case for me with a job I had.

Good point standing at a bus stop would be a nightmare for more than a couple of minutes - would be very lucky to have a seat at the bus stop If I had to travel to work I would be forced to get a taxi.

 

[Luther Blissett]

I'm quite spicy cos I'm covered in chili sauce so it's totally up to you.

Well, basically you've already asked it! Best to keep it at that as members have varying sensibilities on things like "licking!"

LIKE... I meant like, darn auto-correct.

That's my story and I'm sticking to it

 

[Valentijn]

I'm quite spicy cos I'm covered in chili sauce so it's totally up to you.

Doesn't that sting?

 

[Solstice]

A couple of good BMJ rapid responses

Ian Stirling declares no competing interests where he should clearly state he's a patient!

Or so would the pace authors parry critique.

 

[Barry53]

Ian Stirling declares no competing interests where he should clearly state he's a patient!

Quite, so we can be sure no undeclared risk of researchers' best interests being jeopardised.

 

[Large Donner]

Doesn't that sting?

That's why I need someone to lick it off.

 

[Luther Blissett]

That's why I need someone to lick it off.

Oh what a good ide...

WAIT! ...

 

[Barry53]

That's why I need someone to lick it off.

This is sounding like an increasingly high risk thread .

 

[Sean]

 

[Manganus]

Good point standing at a bus stop would be a nightmare for more than a couple of minutes - would be very lucky to have a seat at the bus stop If I had to travel to work I would be forced to get a taxi.

This is true!

(And obviously one of the points were living in (western) Europe is a great advantage. I've virtually always been able to go by bus to the work. 12, 20 & 60 miles.)

 

[Dolphin]

http://www.bmj.com/content/357/bmj.j3057/rapid-responses

Re: Self help approach to graded exercise may help chronic fatigue syndrome

Susan Major’s (1) review of this recently published research in the Lancet (2) is woefully uncritical. Both of the main outcome metrics used in this trial are patient self-reported, questionnaire measures – fatigue and physical functioning. This pragmatic randomised controlled trial was not blinded. Together this causes difficulty interpreting the outcomes of such trials due to the potential for bias, highlighted and summarised by Jonathan Edwards (3). Had the researchers used objective measures, for example, actigraphy to determine if physical activity actually increased as proposed this would have provided a great deal more information. Moreover, it would have provided a clue as to actual adherence to the graded exercise hypothesis. This has been called for before this trial started, and is long overdue(5).
When measures of activity have been used in CFS trials aimed at increasing patients activity no clear pattern could be ascertained even when patients self reported well-being improved(4).

Patients report very low levels of physical activity and high levels of fatigue compared to those reported by well controls of the same age and gender, at the beginning of the trial. It cannot be discounted due to the obvious possibility for bias that the modest, small changes for the better were more than likely accounted for by the placebo effect – patients wishing to please their therapists. It would be odd if they were not so. CFS patients require interventions with extremely large effect sizes to feel a great deal better – to recover to anything like ‘normal’ functioning for their age range.

To persuade this practicing psychologist that encouraging patients whose main symptoms include an inability to maintain and repeat even trivial amounts of physical and cognitive activity that doing more of what makes them very ill will help them, researchers at a minimum need to move to using objective measures if they are to demonstrate reliable improvement. Furthermore, researchers need to be a great deal more ambitions if they are to change patients’ lives for the better.
The lack of attention to biomedical markers in immunology, neuroendocrinology, autonomic nervous system, cellular and mitochondrial dysfunction (6) is likely to bear fruit here and is wholly ignored in this type of research (2).

When I meet with patients with CFS in my clinics I do not find them desiring further psychologically based trials that repeat the same, small/modest effects that can be accounted for by the placebo effect.
What I do find overwhelmingly is that patients, their families, carers, and their physicians want interventions aimed at recovery – which requires vast effect size changes across all measures of well-being, which can be objectively measured too. Including, for example, return to work (or equivalent), reduced need for sickness welfare and disability payments, reduced usage of medical resources and increased ability to complete standardised exercise tests (e.g.
VO2Max) on two consecutive days unimpeded by debility. This is unlikely to come from psychologically based interventions.

1 Mayor S. Self-help approach to graded exercise may help chronic fatigue syndrome. BMJ 2017;357:j3057.
2 Clark LV, Pesola F, Thomas JM, et al. Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial. Lancet 2017. doi:10.1016/S0140-6736(16)32589-2.
3 Edwards, J. PACE team response shows a disregard for the principles of science. Journal of Health Psychology, March 28, 2017.
http://journals.sagepub.com/doi/full/10.1177/1359105317700886
4 Friedberg, F. & Sohl, S (2009). Does graded activity increase activity? A case study of chronic fatigue syndrome. Journal of Behaviour Therapy and Experimental Psychiatry, 33, 203–215.
5 Haywood et al. (2011) Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review.
6 Komaroff, A.L., and Cho, T.A. (2011). Role of Infection and Neurologic Dysfunction in Chronic Fatigue Syndrome. Seminars in neurology. Vol 31(3).

Competing interests: No competing interests

26 June 2017
Joan S Crawford
Counselling psychologist
Chester MESH
Chester

 

[medfeb]

The NICE criteria are not at all bad really, if followed. https://www.nice.org.uk/guidance/cg53/chapter/1-Guidance#diagnosis

They are rather similar to Fukuda, for example, but with the addition that PEM is mandatory in NICE.

I'm not as confident about the NICE criteria and find it confusing how NICE defines PEM. NICE does say that the fatigue is "characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)." But then NICE also states that "physical or mental exertion makes symptoms worse" is an optional symptom.

Exacerbation of symptoms following exertion is a core feature of PEM, along with loss of function/stamina. So how does NICE define PEM if exacerbation of symptoms is considered optional? What am I missing?

 

[Deepwater]

I'm not as confident about the NICE criteria and find it confusing how NICE defines PEM. NICE does say that the fatigue is "characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)." But then NICE also states that "physical or mental exertion makes symptoms worse" is an optional symptom.

Exacerbation of symptoms following exertion is a core feature of PEM, along with loss of function/stamina. So how does NICE define PEM if exacerbation of symptoms is considered optional? What am I missing?

I believe the NICE guidelines were written by a committee half of whom believed in ME and half of whom believed in BPS twaddle. Same sort of lumpy result as a camel.

 

[Karen Kirke]

You may remember #GETSET Julie, a hypothetical patient who featured in the GETSET booklet for patients, discussed in this thread. That booklet was written by 9 GET therapists working in the NHS, edited by GETSET lead author Clark, and help of White, Cunningham and Bavinton was acknowledged (see back page).


(If you don’t know Julie, see p.10 and 11 of the GETSET booklet for patients, where the hypothetical Julie works full-time, studies 4 hours a week, walks and does yoga before she even starts graded exercise. http://www.wolfson.qmul.ac.uk/images/pdfs/getset/GET guide booklet version 1 22062010.pdf)


The GETSET therapist manual, written by Clark, Tims and White, talks about Julie:


“The examples of diaries (boom-bust; page 10 and stabilised; page 11) in the GET booklet are rather complex and difficult to interpret.” (p.20)


“It is recognised that the diaries shown on p.10-11 of the GET booklet are rather complicated for participants to understand. They may require some explanation, breaking them down into sections. Further to this, some participants will not be working and therefore there [sic] days will not resemble the examples in any way, making it difficult for participants to relate them to their own patterns of activities.” (p.48)


It seems that at least one of Clark, Tims and White recognised that the fact that Julie is working may set her apart from some trial participants, although there is no mention of her being a veritable activity ninja before she even commences graded exercise - working full-time, studying, going for walks, taking a yoga class, going out with friends, shopping. The decision to put Julie in the patient booklet and keep her there despite her far-fetchedness is one I cannot conjure a rationale for. It suggests that even within a trial such as this, the understanding of ME/CFS by GET therapists (i.e. those who created Julie) leaves a lot to be desired.


I’d be interested to know how many of the study participants were able to work, study, or work and study at baseline, and how this compares to the ME/CFS population, and to Julie.

 

[TiredSam]

That booklet was written by 9 GET therapists working in the NHS

That is very disturbing, that 9 GET therapists can together come up with such an inaccurate characature of an M.E. patient. It shows a shocking lack of understanding of M.E. I can only assume that they were originally in the meeting room to change a lightbulb so their mind wasn't really on the job of writing the booklet.

It is recognised that the diaries shown on p.10-11 of the GET booklet are rather complicated for participants to understand.

Yes Peter, it's really really complicated. I'm sure many participants will have never seen a weekly timetable before, or understand the concept of dividing things into three categories.