Investigating the effectiveness ... of FITNET-NHS compared to Activity Management to treat paediatric CFS/ME, 2018, Crawley et al. Protocol

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hixxy

Senior Member (Voting Rights)
Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial.

Baos S, Brigden A, Anderson E, Hollingworth W, Price S, Mills N, Beasant L, Gaunt D, Garfield K, Metcalfe C, Parslow R, Downing H, Kessler D, Macleod J, Stallard P, Knoop H, Van de Putte E, Nijhof S, Bleijenberg G, Crawley E.

Abstract

BACKGROUND:
Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS.

METHODS:
Seven hundred and thirty-four paediatric patients (aged 11-17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders.

DISCUSSION:
If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions.

TRIAL REGISTRATION:
ISRCTN registry, registration number: ISRCTN18020851 . Registered on 4 August 2016.

KEYWORDS:
Activity management; CBT; CFS/ME; Chronic fatigue syndrome; E-counselling; E-health; E-therapy; Myalgic encephalomyelitis; Online systems; Paediatrics
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https://www.ncbi.nlm.nih.gov/pubmed/29471861
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3
 
I was wondering what they'd say about their media campaign in the 'recruitment' section, but they didn't mention it.

I didn't mean to read this, so was just skimming though, but thought that the description of 'activity management' makes it sound like GET but just with less of the stuff likely to induce response bias, and a less convenient way of accessing it compared to FITNET.

They have school attendance as an outcome measure, but do not mention whether this will be verified with the school or not.

LOL - this bit is ridiculous!!!

As Activity Management and CBT are behavioural interventions it is not feasible to blind participants or clinicians to allocation. However, the research team have worked to ensure the information sheets present the two treatments in a balanced way, and recruiters have had training to try and encourage participant equipoise. The analyses will be conducted by a researcher blinded to treatment allocation. As we are investigating CFS/ME, the outcomes are patient-reported outcomes. These outcomes are consistent with illness domains that are the most important to patients. The outcomes at follow-up are not reported to clinicians to reduce performance bias.
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Lets remember how the mass media was used to attract participants for this trial:

Landmark chronic fatigue trial could cure two-thirds
By James Gallagher Health and science reporter, BBC News website
  • 1 November 2016
  • From the section Health

A therapy that successfully treats two-thirds of children with chronic fatigue syndrome is being trialled for NHS use.
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https://web.archive.org/web/20161101014733/http://www.bbc.co.uk/news/health-37822068

Young people to get ME treatment in trial after success in Netherlands
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https://www.theguardian.com/society...-syndrome-treatment-trial-success-netherlands

They really tried their best to ensure that the information provided encouraged participant equipoise.
 
Esther12 said:
I don't know... I reckon fatigue questionnaires are even more prone to problems there. I actually considered posting genuine praise for them going for the outcome that was only second most likely to suffer from problems with bias. My standards are that low!
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Didn't Carolyn Wilshire show that GET biased improved the physical function questionnaire more while CBT was better for the fatigue scale?
 
Looks like there's still a GET component within FITNET:

"If participants are identified as being relatively active with a varying level of activity, they first find their baseline before increasing slowly. If they are defined as being ‘low active’ with little variation in activity, they immediately start with increasing activity [17]."

I'd forgotten the new Wilshire PACE reanalysis showed that, but I think that the Chalder Fatigue Questionnaire is so poorly designed that I'd still rate almost anything over that though.
 
There has already been quite a damning peer reviewed paper in response to FITNET ( dr simsin and vink?) and if course the virology blogs.

This however gets to the new target of housebound and will be tailored to suit that soundbite.

NB being in school is not the same as learning at school.... obvious but then so many things are.
Initial response improvement is due to the fact energy us not used up to travel, nothing to do with CBT....
 
'As Activity Management and CBT are behavioural interventions it is not feasible to blind participants or clinicians to allocation. However, the research team have worked to ensure the information sheets present the two treatments in a balanced way, and recruiters have had training to try and encourage participant equipoise. The analyses will be conducted by a researcher blinded to treatment allocation. As we are investigating CFS/ME, the outcomes are patient-reported outcomes. These outcomes are consistent with illness domains that are the most important to patients. The outcomes at follow-up are not reported to clinicians to reduce performance bias.'

They have really learned nothing have they. They now make it explicit that they do not understand the way human nature biases therapist -delivered treatment studies and why we have placebo controls in the first place. What they are saying is 'we can only do a bad study so we will have to do a bad study and people will have to accept it as valid.

'Recruiters have had training to try and encourage patient equipoise' is laughably ingenuous, or perhaps disingenuous.
 
Amw66 said:
Unfortunately until we can get alternative arguments into the mainstream this will continue and funds will continue to be mis spent.
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I think Twitter is the mainstream now and the arguments are out there. The MRC might have been the mainstream once but in recent years it has been increasingly dead wood. The old system will continue for a while but it is basically busted now as far as ME research goes.
 
Esther12 said:
Looks like there's still a GET component within FITNET:
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I think the lines between GET and CBT have been getting increasingly blurred, deliberately possibly. CBT is a tool, just like a blade is, and it's as much to do with what kind of blade you use and what you do with it. A surgical scalpel is obviously a life saver in the right hands, but try the same with a plastic disposable knife you just pulled out of the bin?
 
There will always be a GET component within their model of CBT. Whatever they call it, they cannot escape from the function it is supposed to fulfill in the therapy. Even if they drop it in the descriptions and just call it CBT.

I cannot stress it enough, their model of CBT is the phobia model of treatment. That they don't explicitly call 'cfs/me' 'activity phobia' is irrelevant to what the model is supposed to do, and the theories it is based on.
 
Luther Blissett said:
There will always be a GET component within their model of CBT. Whatever they call it, they cannot escape from the function it is supposed to fulfill in the therapy. Even if they drop it in the descriptions and just call it CBT.

I cannot stress it enough, their model of CBT is the phobia model of treatment. That they don't explicitly call 'cfs/me' 'activity phobia' is irrelevant to what the model is supposed to do, and the theories it is based on.
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If they drop it they can no longer, however wrongfully, claim that they are making patients better. Just that they are helping them cope, and you don't need to research that, cause that sort of CBT is already a thing. Also people coping just fine on their own wouldn't need their help offcourse.
 
FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) - a trial protocol and some questions...

FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) is an initiative discussed in a recent study protocol paper published by Sarah Baos and colleagues [1]. It continues a research interest based on previous published results from a trial undertaken in the Netherlands by Sanne Nijhof and colleagues [2] looking at a possible intervention option for adolescents with chronic fatigue syndrome (CFS) (also referred to as myalgic encephalomyelitis, ME by some).
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by Paul Whiteley PhD

continues at:

https://tinyurl.com/y9q5vtwj
i.e.
https://questioning-answers.blogspot.ie/2018/02/fitnet-nhs-fatigue-in-teenagers-protocol-cfs.html
 
BruceInOz said:
Didn't Carolyn Wilshire show that GET biased improved the physical function questionnaire more while CBT was better for the fatigue scale?
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Sorry, just saw this. We looked at the number of participants that reached the threshold specified in the trial protocol for having improved on the two main scales - fatigue (CFQ) and physical function (SF36). These were the findings:

Rates of protocol-specified improvement on the fatigue scale were significantly higher for the CBT group than for the specialised medical care (SMC) group. The difference between the GET and the SMC groups was not significant.

Rates of protocol-specified improvement on the physical function scale were significantly higher for the GET group than for the specialised medical care (SMC) group. The difference between the CBT and the SMC groups was not significant.

This is interesting, but it falls short of showing that the two therapies operated in different ways. We can't say this because we didn't directly compare the CBT and GET groups in these analyses. We just compared each one to SMC.
 
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