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

[Dolphin]

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.

https://twitter.com/user/status/1852745340547375408

 

[ME/CFS Science Blog]

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.

The small number of reports from participants and clinicians of a worsening condition at the point of reporting of an adverse event or treatment withdrawal were predominantly in the FITNET-NHS group (see Table 12), perhaps due to the more frequent contact in the FITNET-NHS intervention leading to the more adverse events being reported (one or more adverse events or serious adverse events reported for 28 participants in the FITNET-NHS group and 18 participants in the Activity Management group), and more treatment withdrawals (61 participants in the FITNET-NHS group and 12 participants in the Activity Management group).

 

[rvallee]

Both groups continued to improve, and no clear difference in physical function remained at 12 months

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.

What I don't understand with this trial design is that, given that PACE found no difference between CBT and GET, and it's so called efficacy was on the basis of comparing these with SMT and APT. Yet in this trial they set up what is effectively CBT versus GET, and expected to find a difference. The good thing about it is that they found no significant cost effective difference so that dumps both CBT and GET online versions in the bin.

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:

At 6 months, adolescents saw greater improvements in physical function, and attended half a day more school per week, with Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management. Both interventions were associated with improvements over 12 months, with there being no clear difference between them after that time. However, the Fatigue In Teenagers on the interNET in the National Health Service treatment was more expensive.

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.

The number completing 80% or more of expected modules/sessions was lower for FITNET-NHS participants (58, 38%) compared to Activity Management participants (124, 78%).

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

In the qualitative interviews, families felt online treatment could fit around everyday life and reduce the increase in symptoms that can accompany travelling to face-to-face appointments.

Most participants in the FITNET-NHS group did not complete 80% or more of the recommended treatment modules. While our qualitative data suggest that FITNET-NHS was acceptable to most patients, it was considered burdensome by some.

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

This study is consistent with previous RCTs that demonstrated the effectiveness of CBT for children and young people with ME/CFS.

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

It is the first study to attempt to look at cost-effectiveness.

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

This study strengthens the evidence that CBT is effective for adolescents with ME/CFS and should be the first line of treatment offered. FITNET-NHS is an intensive treatment approach and is unlikely to be cost-effective. However, the online approach was popular with patients and families.

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:

The sensitivity analyses confirmed the primary analysis. This was true for participants with ME/CFS defined using the NICE (2021) criteria.

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.

 

[Dolphin]

Two comments by Sarah Tyson:

https://twitter.com/user/status/1852757840454180946

https://twitter.com/user/status/1852761829917036968

 

[ME/CFS Science Blog]

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

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

 

[rvallee]

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.

 

[Trish]

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

That was quick! A very useful summary, thank you.

It's interesting to see just how badly this trial failed in all its objectives - recruitment, retention, outcomes, cost effectiveness.

I was going to say what a humungus waste of a million pounds, but perhaps it was worth that money to finally kill off this diabolical treatment.

I just hope the young people who participated weren't permanently harmed.

 

[Sean]

A 166-page report, in an NIHR journal. How strange.

It seems they've not bothered to plot up the results for the primary outcome and instead have presented the results in a table.

If a study does not give plots of data that is a big red flag to me. Strongly suggests they have something to hide, like any 'positive' results are just due to a small number of outliers.

The activity management is described as also being called pacing, and then involved encouraging 10-20% increases in activity. "Participants were encouraged to increase activity until they were able to do up to 8 hours of cognitive and physical activity a day."

GET Lite, for 8 hours.

FFS.

I think it is completely unethical to tell a child that.

Any researcher or clinician with that attitude or employing those tactics should be fired immediately, IMHO.

Another remarkable figure that does not receive a lot of attention in the abstract: the percentage of patients completing 80% or more of expected modules/sessions was 78% in the Activity Management control group but only 37.4% of the intervention group.

That alone makes the whole thing a non-starter. How can any reliable useful comparison be made with that huge discrepancy?

When I got sick, trying to maintain higher school attendance destroyed me, but it took 1-2 years before it could no longer be denied. The desire to believe in a positive story of self-improvement is very strong and children don't have the permission to go against adult's views.

These children are trying to protect themselves from deterioration by limiting activity. The instinct to do less is correct and not a flaw.

This.

That kind of deceit has no place in health care or academia.

 

[bobbler]

Full title: Comparison of cognitive behaviour therapy versus activity management, both delivered remotely, to treat paediatric chronic fatigue syndrome/myalgic encephalomyelitis: the UK FITNET-NHS RCT

Authors:
Esther Crawley, Emma Anderson, Madeleine Cochrane, Beverly A Shirkey, Roxanne Parslow, William Hollingworth, Nicola Mills, Daisy Gaunt, Georgia Treneman-Evans, Manmita Rai, John Macleod, David Kessler, Kieren Pitts, Serena Cooper, Maria Loades, Ammar Annaw, Paul Stallard, Hans Knoop, Elise Van de Putte, Sanne Nijhof, Gijs Bleijenberg & Chris Metcalfe.

Abstract

Design
Parallel-group randomised controlled trial.

Methods
Participants
Adolescents aged 11–17 years, diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome and with no local specialist treatment centre, were referred to a specialist service in South West England.

Interventions
Fatigue In Teenagers on the interNET in the National Health Service is a web-based myalgic encephalomyelitis/chronic fatigue syndrome-focused cognitive–behavioural therapy programme for adolescents, supported by individualised written, asynchronous electronic consultations with a clinical psychologist/cognitive–behavioural therapy practitioner. The comparator was videocall-delivered activity management with a myalgic encephalomyelitis/chronic fatigue syndrome clinician. Both treatments were intended to last 6 months.

Objectives
Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for paediatric myalgic encephalomyelitis/chronic fatigue syndrome. Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for those with mild/moderate comorbid mood disorders. From a National Health Service perspective, estimate the cost-effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management over a 12-month horizon.

Primary Outcome
36-item Short Form Health Survey Physical Function subscale at 6 months post randomisation.

Randomisation
Web-based, using minimisation with a random component to balance allocated groups by age and gender.

Blinding
While the investigators were blinded to group assignment, this was not possible for participants, parents/carers and therapists.

Results
The treatment of 314 adolescents was randomly allocated, 155 to Fatigue In Teenagers on the interNET in the National Health Service. Mean age was 14 years old and 63% were female.

Primary outcome
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). The mean difference was 8.2 (95% confidence interval 2.7 to 13.6, p = 0.003). The result was similar for participants meeting the National Institute for Health and Care Excellence 2021 diagnostic criteria.

Secondary outcomes
Fatigue In Teenagers on the interNET in the National Health Service participants attended, on average, half a day more school per week at 6 months than those allocated Activity Management, and this difference was maintained at 12 months. There was no strong evidence that comorbid mood disorder impacted upon the relative effectiveness of the two interventions. Similar improvement was seen in the two groups for pain and the Clinical Global Impression scale, with a mixed picture for fatigue. Both groups continued to improve, and no clear difference in physical function remained at 12 months [difference in means 4.4 (95% confidence interval −1.7 to 10.5)].

One or more of the pre-defined measures of a worsening condition in participants during treatment, combining therapist and patient reports, were met by 39 (25%) participants in the Fatigue In Teenagers on the interNET in the National Health Service group and 42 (26%) participants in the Activity Management group.

A small gain was observed for the Fatigue In Teenagers on the interNET in the National Health Service group compared to Activity Management in quality-adjusted life-years (0.002, 95% confidence interval −0.041 to 0.045). From an National Health Service perspective, the costs were £1047.51 greater in the Fatigue In Teenagers on the interNET in the National Health Service group (95% confidence interval £624.61 to £1470.41). At a base cost-effectiveness threshold of £20,000 per quality-adjusted life-year, the incremental cost-effectiveness ratio was £457,721 with incremental net benefit of −£1001 (95% confidence interval −£2041 to £38).

Conclusion
At 6 months post randomisation, compared with Activity Management, Fatigue In Teenagers on the interNET in the National Health Service improved physical function and school attendance. The additional cost of Fatigue In Teenagers on the interNET in the National Health Service and limited sustained impact mean it is unlikely to be cost-effective.

Open access, https://www.journalslibrary.nihr.ac.uk/hta/VLRW6701#/full-report

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.

 

[bobbler]

That was quick! A very useful summary, thank you.

It's interesting to see just how badly this trial failed in all its objectives - recruitment, retention, outcomes, cost effectiveness.

I was going to say what a humungus waste of a million pounds, but perhaps it was worth that money to finally kill of this diabolical treatment.

I just hope the young people who participated weren't permanently harmed.

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.

 

[bobbler]

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.

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.

 

[Amw66]

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.

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

 

[Nightsong]

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?

It is interesting, but I wonder if long summer breaks in schools and universities have something to do with the reduced number of referrals?

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):

Results of the primary analysis are presented in Table 15. After multiple imputation and adjusting for
age, gender and baseline EQ-5D-Y score, the FITNET-NHS group had a small gain in QALYs (0.002, 95% CI −0.040 to 0.045) compared to Activity Management.

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.

 

[rvallee]

I was going to say what a humungus waste of a million pounds, but perhaps it was worth that money to finally kill off this diabolical treatment.

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.

 

[Robert 1973]

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

Good Summary. Thanks.

Couple of minor things:

Unfortunately, the abstract and summaries of the study do not mention that the primary outcome difference was not clinically significant in their abstract or summaries.

Repetition of "abstract and summaries".

It seems rather cruel to tell children that they themselves are preventing recovery through their unhelpful thoughts and behaviors while this may not be the case.

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).

 

[ME/CFS Science Blog]

Couple of minor things:

Thanks!

 

[InitialConditions]

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