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

glimpsesofme said:
It is perhaps worth considering that some of the questionnaires used to quantify mood disorders in both adult and paediatric populations might cause their prevalence to be overestimated in ME patient cohorts. For example, the paediatric RCADS scale includes at least five questions that will likely be scored highly by ME patients regardless of the status of their mood: q11 ("I have trouble sleeping"); q19 ("I have no energy for things"); q21 ("I am tired a lot"); q25 ("I cannot think clearly"), and, for those with orthostatic tachycardia, q24 ("When I have a problem, my heart beats really fast").

Similar questions exist on the adult BDI-II: q15 (loss of energy); q16 (changes in sleeping pattern); q19 (concentration difficulty); q20 (tiredness or fatigue).
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That is really interesting. It sounds like classic BPS logic, where their testing for the presence of mood disorders is predicated on the assumption that the collection of symptoms the are querying can only be due to mood disorders, and not physical causes.

To me it feels worthy of further discussion here. Do you have any links to some of these questionnaires?
 
Adrian said:
I would have thought this was very dodgy. They should have done power calculations for the initial ethics approval to size the trial so cutting in half suggests that they either got these wrong or they are running a trial which may risk not having sufficient participants to give a meaningful result.
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Also, what's the point of having a 'stop criteria' if you just ignore it?
 
I was just going to post something else in this thread, and finding it made me wonder if asnyone had an answer to this question...
Esther12 said:
Also, what's the point of having a 'stop criteria' if you just ignore it?
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Also, it seems the Bristol FITNET pages have been updated, including a new FAQ with their interpretation of the previous FITNET study:

http://www.bristol.ac.uk/academic-c...entdisability/chronic-fatigue/fitnet-nhs/faq/

The old FAQ included a link to Crawley's TEDx talk, that was taken down after it was pointed out she'd breached their guidelines and made false claims, but that old FAQ is still available here: https://web.archive.org/web/2018063...entdisability/chronic-fatigue/fitnet-nhs/faq/
 
Sorry just catching up to this, it escaped my attention earlier. The change in interventions seems to be a doubling of the sessions for Activity Management from three initially to six later on, from the changes in the descriptions on the registration. I haven't seen an explanation for that change.
 
Just saw this thread about the protocol's never ending amendments and thought I'd link here:

Sly Saint said:
another one! 19 Dec 2019
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): amendment to the published protocol
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3895-1

eta: seems to be revised target recruitment to 314 children and 6 month extension to Oct 2021
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MSEsperanza said:
Just saw this thread about the protocol's never ending amendments and thought I'd link here:
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This is just so damn bizarre and ridiculous:
We considered the issue of co-morbid disorders. On 2 October 2018, we investigated the rate of co-morbid mood disorders in FITNET-NHS participants at baseline. This was higher than our original estimates as the rate of co-morbid mood disorders was 40% (compared to 30% in our original estimates). With the revised sample size target of 314 there will be approximately 106 participants with co-morbid mood disorders (53 in each treatment group). This will give 53% power at 5% significance to detect a 0.4-SD difference on the SF-36-PFS between treatment groups within this co-morbid subgroup.
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They self-select for a % of specific "co-morbid". Then find they have too many of those based on an arbitrary target. Why have a target at all when it should be an exclusion factor? Also ridiculous to speak of standard deviations and power % when they are using biased unreliable questionnaires that have little to do with the illness. They don't even get round-number accuracy, even within several points of an accurate number, and are trying to argue for several significant digits? Who the hell approves this garbage?

So after 3 years they are unable to meet a low target that itself represents a tiny miniscule % of the patient population (though of course they select way out of the ME population anyway so those numbers are even worse) and can't even get to half of that and their conclusion is that instead of accepting that this is a worthless pursuit they give it more time?

That this gets funding and continued approval over credible research is complete abdication by the relevant research authorities.
 
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