Guided graded exercise self-help for chronic fatigue syndrome: Long term follow up & cost-effectiveness following the GETSET trial, 2021, Clark et al

Andy

Andy

Retired committee member
Highlights

• Guided graded exercise self-help (GES) can lead to sustained improvement in patients with chronic fatigue syndrome.
• There was no evidence of greater harm after GES compared to specialist medical care at long-term follow-up.

• The study showed that GES was probably cost-effective.

• Most patients remained unwell at follow up; more effective treatments are required.

Abstract

Objective
The GETSET trial found that guided graded exercise self-help (GES) improved fatigue and physical functioning more than specialist medical care (SMC) alone in adults with chronic fatigue syndrome (CFS) 12-weeks after randomisation. In this paper, we assess the longer-term clinical and health economic outcomes.

Methods
GETSET was a randomised controlled trial of 211 UK secondary care patients with CFS. Primary outcomes were the Chalder fatigue questionnaire and the physical functioning subscale of the short-form-36 survey. Postal questionnaires assessed the primary outcomes and cost-effectiveness of the intervention 12-months after randomisation. Service costs and quality-adjusted life years (QALYs) were combined in a cost-effectiveness analysis.

Results
Between January 2014 and March 2016, 164 (78%) participants returned questionnaires 15-months after randomisation. Results showed no main effect of intervention arm on fatigue (chi2(1) = 4.8, p = 0.03) or physical functioning (chi2(1) = 1.3, p = 0.25), adjusting for multiplicity. No other intervention arm or time*arm effect was significant. The short-term fatigue reduction was maintained at long-term follow-up for participants assigned to GES, with improved fatigue from short- to long-term follow up after SMC, such that the groups no longer differed. Healthcare costs were £85 higher for GES and produced more QALYs. The incremental cost-effectiveness ratio was £4802 per QALY.

Conclusions
The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up. The cost per QALY for GES compared to SMC alone was below the usual threshold indicating cost-effectiveness, but with uncertainty around the result.

Paywall, https://www.sciencedirect.com/science/article/abs/pii/S002239992100129X

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Same as usual. Failure spun by lies, again with conclusions mostly detached from the actual evidence, basically self-contradictory, as is tradition. This time published in their own journal, a backwater publication on which the main people behind this treatment model are on the advisory board. A journal run by an organization run by one of the creators of this failed pseudoscience.

Exact same stuff the very same people have been saying for over 3 decades, unchanged from their original claims. The economic analysis basically belongs in the fiction section of a filing cabinet equipped with a shredder.

It's frankly amazing that they can both report plainly that there are no differences in outcomes and still argue that it's effective. Even more amazing that anyone would actually take those claims seriously despite the evidence completely contradicting the claims.

It apparently took 5 years to spin this turd. Honestly the results paragraph is impossible to follow, it's just very ineffective spin trying to admit failure while claiming otherwise. An application of sophistry for the ages.
 
dave30th said:
yes, excellent question. What does that even mean? Cost-effective at doing what??
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Improving the way people fill in quality of life questionnaires for one year?

I've only read the abstract but if they have a low additional cost for GES then small and short-term changes in how people fill in questionnaires could be classed as cost effective: "Healthcare costs were £85 higher for GES and produced more QALYs."
 
Conclusions
The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up.
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1. Same as PACE, then. No benefit of GES/GET over doing nothing.

2. I want to see the slopes of the response curves. Bet the GES results most closely matches a standard asymptotic decay curve (regression to the mean), and the SMC result instead shows continuous improvement. Same as PACE.

Which would give us two major trials showing the same results: GES/GET doesn't work, and leaving patients to get on with figuring out for themselves how to manage their activity patterns delivers a better long term outcome.
 
This is very late publication of follow up results from a trial that took place 5 years ago. I wonder whether they held off publishing until after the new NICE ME/CFS guideline was expected to be finalised, given that the null result supports the recommendation against GET.
 
The highlights and the spin on the results are very deceptive. In no way should peer review and editing have allowed those to be published as such, but Peter White sits on the advisory board of the Journal of Psychosomatic Research...

What is the point of doing a controlled study if the results of the control arm are to be disregarded?

It would have been honest to conclude that GET is not effective compared to standard medical care (which probably involved pacing), and that it is inevitably more expensive, thus there is no reason to offer it as a treatment for CFS.

@dave30th It could be worth reporting this article to the editor-in-chief of JPR, Jess Fiedorowicz, given the recent article on biased subjective outcomes in unblinded trials he wrote. If scientific integrity matters to him as an EiC, then he should not let this slip as-is.
 
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Andy said:
Trial By Error: GETSET Study Reports Null Results for Self-Help Graded Exercise–but Declares Success Anyway

https://www.virology.ws/2021/04/06/...-graded-exercise-but-declares-success-anyway/
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Would be good if we could get an objectively-written article on this into the mainstream press - is there a better chance of this these days? Key points to get across to a generally disinterested public, and maybe get them interested, could be:
  1. Abstracts and conclusions published by investigators are their interpretations of the results, and so can also be their misinterpretation of the results. The veracity of this is down to their integrity and competence.
  2. The simple improvement figures for a treatment being trialled are not what counts! It is how that treatment faired compared to not having that treatment, all other things being equal. If there is no difference then the treatment achieved nothing.
  3. For investigators to not clarify '2' is incompetent at best and deceitful at worst. And to deliberately obfuscate it is deeply dishonest, deeply unprofessional, and maybe fraudulent. In many other professions such behaviour would warrant disbarment. Maybe also a public enquiry if the detrimental effects are on such a wide scale as this.
  4. Sharpe himself has emphasised the importance of noting the difference between arms being a "key finding" ... but only when it suits him it seems. See https://www.s4me.info/threads/esthe...erometer-magenta-data.9141/page-3#post-180036.
  5. Most of the lay public have a blind faith in "science" and "scientists", as I once did ... blissful ignorance. Many people simply will not entertain the notion that scientists can report their findings dishonestly, or even incompetently, no matter the examples that occasionally pop into the news over the years. And people can react strongly to having their blind faith challenged, so the arguments presented have to be understandable by them before they pull the shutters down.
We must remember the general public have negligible understanding on such things, and what will seem trivial and blindingly obvious to us, will likely be new insights and obscure to most people. Until now most people have had little interest in ME/CFS unless touched by it in some way, but this is different now. Everyone has been touched to some degree by Covid 19 and Long Covid, so any article in the mainstream press about scientists making a mockery of the issue, might be much more likely to be read by most people. But the article must be properly pitched.
 
Esther12 said:
I've only read the abstract but if they have a low additional cost for GES then small and short-term changes in how people fill in questionnaires could be classed as cost effective: "Healthcare costs were £85 higher for GES and produced more QALYs."
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My guess (and I've only skimmed the abstract) is that they are claiming that the earlier reduction in fatigue creates a more quality of life per year and hence with a relatively small additional cost it their intervention becomes cost effective.
 
One way in which an ineffective online therapy is cost effective would be if the alternative is going to a clinic and being treated by therapist for a series of sessions that are equally ineffective.

For the NHS, cynically speaking, that is a win. No need for clinic buildings and staff, just send people away with an online link and leave them to work alone on a program with little or no therapist real time input.
 
Trish said:
How can it be cost effective if it doesn't work, as this research showed.
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I've an uncomfortable feeling the notion of being "cost effective" might be as crude as being much less expensive than an alternative therapy the NHS would otherwise be obliged to fund. Whether it works may not be much on the radar of the bean counters, and the political influences behind them. If they can be convinced something is "cost effective", and that most normal people would be unable to prove otherwise, then that probably suits them just fine.

And yes, I do believe "Yes Minister" was very close to reality ... I mean - given what we know of human nature, what are the odds it was not?
 
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