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MEAction UK condemns FITNET

Countrygirl

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http://www.meaction.net/2016/11/02/...bt-in-treatment-for-chronic-fatigue-syndrome/

MEAction Denounces Use of CBT in Treatment for Chronic Fatigue Syndrome

Patients with ME/CFS Urge NHS to Adopt Scientifically-Sound Approaches to Treatment

Study Finds No Difference in Treatment for ME/CFS Patients At Long-Term Follow-Up

According to reports in The Guardian and BBC yesterday, hundreds of young patients in the UK suffering from myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) are set to receive online psychological therapy. FITNET will cost £1million, to be funded by British taxpayers — yet the Dutch study on which the trial is based found no difference in patients at long-term follow-up.
 

Countrygirl

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She quotes PACE as evidence that CBT is successful.

.
There is good evidence that CBT and GET are moderately effective in adults with CFS/ME. Four systematic reviews have shown that CBT and GET are FITNET-NHS Page 6 of 30 Protocol_v3.0 10/10/2016 moderately effective in improving function and reducing fatigue [12-15]. In particular, the PACE trial showed that both CBT and GET were more effective than specialist medical care or specialist medical care plus adaptive pacing therapy (a form of activity management that does not routinely increase activity but uses the envelope theory (patients work within their envelope of energy)) [16]. There is less evidence for the treatment of paediatric CFS/ME. However, when children are

She forgets to mention that the Dutch trial produced a null result at 2 years follow up.
 

Countrygirl

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Entry criteria:

Those children with 3 months of disabling fatigue plus one symptom [4] (NICE guidance) will be eligible.

Not ME then.

There is no way of knowing, as far as I can tell so far, how many of the fatigued children have ME as PEM is not required. Some will, but they may well be in the minority, based on the definition here of CFS/ME

The CBT modules focus on cognitive behavioural strategies with instructions on exercises for identifying, challenging and changing cognitive processes.


These explore and address parent’s beliefs and behaviours towards their child with CFS/ME. In children younger than 15 years, parents are supported to act as a coach. In those older than 15, parents are encouraged to step back and support their child taking responsibility for their treatment.

This stuff is lifted straight out of the Dutch study protocol. Probably a cut-and-paste job.
 
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Countrygirl

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The research team will only notify fatal and unexpected non-fatal adverse events to the trial Sponsor. Expected adverse events include payback, crashes or flares as described above. Expected adverse events will not be reported to the sponsor.

If I have interpreted this correctly, as relapses are expected as they are characteristic of the illness, they won't be recorded. So, could this mean if a child becomes bedridden during the course, that this won't be noted as an adverse event?
 

Countrygirl

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We will ensure that the trial outcome is known to clinicians by presenting research findings at national and international conferences and meetings. We will cascade information through clinical and research networks including: the British Association for CFS/ME, the UK CFS/ME Research Collaborative (CMRC) and the NIHR National School of Primary Care Research (SPCR). We have a robust plan to raise awareness of CFS/ME and this trial in the first 18 months of this study. At the end of the trial, we will work to further disseminate the findings through blogs, emails, podcasts, Twitter etc. to clinicians and GPs. We will disseminate results to patients through the regional and national paediatric charity (Association of Young people with ME) and adult patient support groups that we work with as well as liaising with other charities to ensure dissemination throughout the UK. We will write “research in progress” articles for newsletters/websites, and speak at their meetings. We will communicate with the public by giving a public engagement lecture, an open academic lecture, press releasing every publication and giving interviews. We will disseminate results to politicians and policy makers using the All Party Parliamentary Group for CFS/ME and members of parliament who are part of the CMRC. We will inform NICE of the trial results so that results can be included in updated guidance.

Gird your loins!
 
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The research team will only notify fatal and unexpected non-fatal adverse events to the trial Sponsor. Expected adverse events include payback, crashes or flares as described above. Expected adverse events will not be reported to the sponsor.
The problem here is that the word "unexpected" is highly loaded, and extremely subjective. If the raw data were to be made available, then independent peer reviewers could apply independent assessment of what is unexpected or not. It is also very worrying to see "will not be reported to the sponsor", implying no raw data will be released, and that FITNET's published results will be all anyone gets to see. It is breathtakingly crass, given PACE.
 

Countrygirl

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14947811_542217225969734_5418180721048061278_n.jpg
 

taniaaust1

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Sth Australia
If I have interpreted this correctly, as relapses are expected as they are characteristic of the illness, they won't be recorded. So, could this mean if a child becomes bedridden during the course, that this won't be noted as an adverse event?

I dont understand how this study then has even been approved. How on earth can one get away with doing a treatment study for an illness and then not reporting if the illness is being made worst by the treatment?
 

taniaaust1

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"We will inform NICE of the trial results so that results can be included in updated guidance."
@charles shepherd might this mean putting of revision of the NICE guidelines until 2022?

well thought out. I would guess that they could get the NICE guidelines revision put off if they go on about how info backing the current guidelines isnt far off if they are held off of revision for a while.

I see so much bad things with this study. I guess its supposed to keep the seriousness of ME/CFS buried due to the recent exposure of PACE.
 

daisybell

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New Zealand
Re the 'expected adverse events', my reading of this is that these will be recorded, but that only non-expected events have to be reported to the trial sponsor. So the data should be there under expected adverse events - but how they choose to report this is another matter. I'm presuming that the expected events will all be lumped together, with no way of telling how serious they are for individuals, and some kind of statement made about how nothing serious happened....
 
Messages
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Location
UK
Re the 'expected adverse events', my reading of this is that these will be recorded, but that only non-expected events have to be reported to the trial sponsor. So the data should be there under expected adverse events - but how they choose to report this is another matter. I'm presuming that the expected events will all be lumped together, with no way of telling how serious they are for individuals, and some kind of statement made about how nothing serious happened....
Which is why open access to the raw data is especially crucial. The very fact that "expected" adverse events will not be reported, leaves the door wide open for any published results to mask/obscure such issues that the data itself may hold. If the research was in the hands of highly trusted researchers, would not seem such a worry. It is only very recently that I have become aware of clinical trials' practices, and I am flabbergasted by what seems to be the accepted norm. Sane checks and balances just do not seem to be there.
 

taniaaust1

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Sth Australia
Re the 'expected adverse events', my reading of this is that these will be recorded, but that only non-expected events have to be reported to the trial sponsor. So the data should be there under expected adverse events - but how they choose to report this is another matter. I'm presuming that the expected events will all be lumped together, with no way of telling how serious they are for individuals, and some kind of statement made about how nothing serious happened....

I'll going to make a psychic prediction :p:p , I predict that there will be people trying to get the raw data for this study as everyone of us will want to know about those unreported "expected" side affects they dont want to report. Can I also predict that withholding of data will be tried again here.

We can see from the start that this study is going to be done to try to hide the truth. umm and surely they know that there will be freedom of info requests on that raw data to find things like this out, so that makes me really wonder how they will deal with this?

Maybe they wont record the expected adverse events as surely they will know we will get that info so they could decide its more better for them not to report then have that reported with results which would come out. Unless they are dumb enough to continue to try to mislead, thinking that people wont go to court to try to get it?. or maybe that info will be said to have gone "missing" later on. I've seen "gone missing" corruption before. (is there any steps which could be taken to ensure this info doesnt go missing?)

If anyone running that study reads this post.. all I can say is you'd best get a plan in place as the ME community isnt going to keep allowing biased studies to keep misleading and we will be working to expose anything hidden. The more you try to hide things and deceive, the more obvious it is becoming to us that things are being hidden. You'll be a fool to keep continuing to believe you can get away with this.

I so hope that a court case people are trying to do, can go ahead for that deceptive PACE trial as that will make those others doing deceptive studies think twice about what they are doing.
 
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taniaaust1

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This seems incredibly presumptive/arrogant to me. Do all trials presume at the outset, that the outcome will be sufficiently successful and worthwhile as to be incorporated into a nation's official clinical guidelines? Or is it just here in the UK?

they already probably have this all stitched up and know exactly what result they wish to come up with and now are probably just planning how exactly they will achieve this desired result. Will we see more study chances mid trial so they can achieve this when things arent working out right for them?
 

Countrygirl

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This seems incredibly presumptive/arrogant to me. Do all trials presume at the outset, that the outcome will be sufficiently successful and worthwhile as to be incorporated into a nation's official clinical guidelines? Or is it just here in the UK?

I am racking my memory cell for the name of a document that I read yesterday and intended to post here that has relevance to Barry's observation. I have hunted for it but can't find it. It made reference to the bodies that are funding FITNET and I recall some surprise at finding that the results of the trial are destined by the funding body for NICE and'or other government guidelines. Prof Michael Sharp is part of the organisation who allocated the grant.

Maybe given the nature of the organisation that is funding FITNET and the planned destination of the 'results', it explains why the conclusions have already been announced before the trial has begun. :whistle: Sorry to be so vague, but maybe someone else also saw the document yesterday. The rest of it quoted chunks of Margaret WIlliam's most recent piece.

It shouldn't too difficult to hunt down or just check the background and purpose of the funding bodies.
 
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Countrygirl

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Professor Sharpe's connection with FITNET is as the senior investigator for the National Institute for Health Research who have awarded EC the grant. See his description below, although it frustratingly doesn't provide the information I read yesterday. I will post it later if I find it again.

  • NIHR Senior Investigator
Psychiatric aspects of medical illness and treatment
My research aims to understand the psychiatric aspects of medical illnesses and their treatments, to develop novel interventions for these that are integrated with medical care and to evaluate these in rigorous clinical trials.

My current interests are in developing integrated medical-psychiatric treatments and services especially for people with depression that is comorbid with medical conditions such as cancer and for elderly medical inpatients.

I am a Fellow of the Royal Colleges of Physicians of London and Edinburgh and of the UK Royal College of Psychiatrists.

I serve as a member of the governing council of the American Academy of Psychosomatic Medicine (APM) and as a member of the executive of the European Association of Psychosomatic Medicine (EAPM). I am theme lead for medical-psychiatric multi-morbidity in the Oxford NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC).