Comparison of [CBT] versus activity management, both delivered remotely, to treat paediatric [CFS/ME]: the UK FITNET-NHS RCT 2024 Metcalfe et al

FIGURE 1 Consolidated Standards of Reporting Trials participant flow diagram. a, Treatment withdrawals between the completion of baseline, 6-month and 12-month assessments, substituted with time point since random allocation if an assessment was not completed.

 

On page 41, the document itself says 61 treatment withdrawals for FITNET compared to 12 for AM. Not sure what the difference with the flow chart comes from.

 

So, entirely consistent with no actual difference in condition, but a difference in how that condition is reported. As was expected of 'treatments' that consist of telling people to do just that. Congratulations, you just re-invented a very expensive way of having people slightly distort their responses on questionnaires.

Fundamentally I object strongly to the Orwellian use of activity management. This is not about activity. It's just a weasel term. Of course we can talk about activities of daily living here but given the horrible history of ME/CFS, we can be confident that in almost all cases this is not how it will be perceived. I guess it's the name they gave to their intervention. That kind of deceit has no place in health care or academia.

But indeed this is truly bizarre. I would have expected that activity management would be something closer to pacing, but this is clearly a veiled CBT vs GET comparison trial. So they were testing two 'treatments' that don't work, as if it should inform anything. When those are two commonly used treatments, despite having negative evidence for.

This was an especially entirely useless trial as there should be no expectation of any difference with being delivered through the Internet. They are both useless interventions, at best, whether someone reads them on a stone tablet or delivered in person by an actual circus.

It's just clearly part of what this fringe industry does: the same thing in loop to sort of refresh the evidence base with the same thing over and over again.

The plain language summary is very misleading. It asserts that CBT is the most effective treatment there is. This is false. It also distorts the findings while reporting them:

Differences that are ironically more likely to be because the AM/GET arm asks the patients to do more, which the patients probably reassess. To state that improvements at 6 months are significant but don't matter at 12 months is like demanding to stop counting election results at 9pm when your candidate is in the lead with 50% of votes counted.

This is simply yet another uninterpretable trial with invalid methodology asking an impertinent question. At best it can be said that GET is worse than CBT, we already knew that, but neither can be said to make any difference since there was no null comparator.

This is a very low compliance rate, which suggests the interventions are not acceptable as they are.

But they are expected to do more, as a treatment, to be more active, to be more in school. Make that make sense.

This is not a valid statement. It cannot be said that this study showed that CBT was effective.

This is also plain false unless it's interpreted as being specifically about FITNET, which is just the same old CBT anyway.

Just plain delusional and false. There is nothing in this study supporting the recommendation that it should be first line treatment. This is absurd.

Notable, in the scientific summary:

They refer to the 2021 NICE guideline, which some of them openly reject, for criteria, but the same guideline explicitly forbids what they did here. Make that make sense.

 

Two comments by Sarah Tyson:

 

Wrote a quick summary of FITNET-NHS on our blog:
https://mecfsskeptic.com/fitnet-nhs-a-summary/

https://twitter.com/user/status/1852806511304843272

 

The 'activity management' group is not a control. Let alone a proper control. What the hell does it control for? None of this is valid research.

 

Same old Krypton Factor trick:

At 6 months, participants allocated to Fatigue In Teenagers on the interNET in the National Health Service were more likely to have improved physical function (mean 60.5, standard deviation 29.5, n = 127) compared to Activity Management (mean 50.3, standard deviation 26.5, n = 138)

So one of these treatments knocked out the most ill to have to drop out and then they compared the average of that 'treatment' without the drop-outs with the other one 'including all'. And instead of starting the reporting with erm x number had to drop out... and really at 6months we don't actually know the full effects on the rest until another 6-12months...

And they are comparing the old pub question of would you rather drink a pint of wee or eat a teaspoon of something else. How unethical are these peopel?

It's so important that we get a description of how the condition works properly understood

I find it so sickening how a mis-sell of some fatigue to behaviourally force people through - always doing it for exactly 6months MAX must be coming from them knowing FULL WELL we'll drop everything else to 'make it happen' for their dodgy KPI by 'hey they can no longer get to the supermarket but they will force themselves to walk a few more metres' into being a lot iller than they might have been in the next 6-12months if only they hadn't been encouraged through that.

 

What's really upsetting me at the moment is seeing or hearing about some really ill people getting the sophism from BPS of 'it must be behavioural because the illness doesn't make you that ill/severe'

including from people who are the use em up and spit em outs of these crappy, deliberately don't measure the harm they do - so it apparently doesn't exist - 'trials'

I can't think of how immoral and callous people have to be to choose to be part of by closing their eyes, by choice, to such patients being the cast-offs broken by their very own ideology who they are now going to further mistreat basically because their methodology seems to require them to 'unsee' those harmed.

It's like a drug harming people, being on their record and then somehow everyone playing games pretending it isn't written down that if some idiot kept dosing that person over and over they'd get even more harmed they will you know look exponentially like x. SO when x turns up you are morally bound to whatever you do not do the same thing again, claimign it doesn't harm. At what point does the person whose body it is and the few moral enough to be honest in their witnessing of what happened get heard.

And it feels as the treatment has been accelerating in how bad and how much it has been all-encompassing and seeking to drag more forcibly under it, we might be watching (where they can't manage to find ways to silence it) those chucked out in states where they've been left desperately harmed to then end up blamed for it. Or assumed by someone 'new' it must be behavioural all over again, because their 'colleagues' decided they are above 'having to annotate harm or yellow cards' ie be honest.

This whole new thing is a new level of horrifying in how bad human beings can get and I'm afraid seems to forget that it's human beings they are playing with whilst they get their own emotions about 'them not hearing to be proven wrong on their beliefs'. How insidious and to dangerous extremes these 'at no point can I reconsider or consider anything that would make my past thoughts wrong, and I take a body that seems to defy that very personally' can stretch to.

 

Thanks for posting this

It is the most important stat

If it weren't for the fact that coercion has to be a massive factor regarding drop-outs and whether they feel they can be truthful about a treatment harming or not working given the perceived threat etc that might nudge /mean people feel it best to quietly tick the box of 'recovered' and keep their head down

I find this whole business so disgusting. It's children. And yet we all know the regime under which these people are operating and putting these parents and children under is wayyyyy beyond anything anyone could suggest a situation where perceived coercion isn't involved.

Any project, particularly those from individuals connected with such things, I would say shouldn't be signed off full-stop based on this clear ethical and safety issue. And noone should take the results as the treatment in hand but about perceived coercion unless any of these start having independently-designed rigid processes that demonstrate no participant could be identified and under perceived threat due to this by the investigators.

I don't know how that could happen if you are registered at a certain place currently, whatever claims of 'it's someone else doing the actual therapy/survey'. And even if they couldn't they might guess (and guess wrongly) at who is 'putting in the bad feedback'

the whole thing is a farce. and those powers shouldn't be in or linked to the notes or suggestions of these people anyway. It's clearly a potential weapon, and you shouldn't have to have some sophist argument about 'wrong hands' when of course there is incentive and beliefs and 'interest' that can't be unlinked from it all anyway.

 

Not just human beings . Children .
Those who are supposed to have more safeguards .
With ME/ CFS they have less ..

 

I know I said I wasn't going to analyse this, but I noticed while skimming through that there was no 3-month outcome data for the secondary outcomes - I just see 6 & 12 month data in Table 10 - the protocol mentions 3, 6, and 12-month outcomes - am I missing something?

Yes, that was what I was wondering, which is why it would be useful to know if the pattern was the same in the adult clinics.

Also (emphasis mine):

Close to 0 and the confidence interval crosses both negative and positive values - zero is within the confidence interval so how could it realistically be described as a gain?

Also, in both the recruitment flyers and in the video for clinicians, treatment response & recovery rates are described in misleading terms.

 

They still recommend CBT, emphasizing that it actually reinforces the evidence for it as first line treatment, while asking for more funding for more of the same research. This is how it will be presented, and this is how most interested parties will choose to interpret it.

This is zombie health care. It can't be killed. It can only be paved over. Unfortunately for us, this is something that can't be walked back. Once they decided on denial of reality, they were always meant to follow through with it until the mic is turned off, the lights are shut, the curtains pulled back and the fire alarm set off.

 

Good Summary. Thanks.

Couple of minor things:

Repetition of "abstract and summaries".

I think "when this may not be the case" would be better English.

I note that you have adopted US rather than UK spelling (eg behaviors).

 

Thanks!

 

Is anyone thinking of submitting a comment, which is essentially a response to the editor letter?