Graded exercise therapy compared to activity management for paediatric [CFS/ME]: pragmatic randomized controlled trial, 2024, Gaunt, Crawley et al.

And was there follow up for the drop outs between 6 and 12 months- 26 and 33 people is not insubstantial

 

A Crawley clinic patient on Twitter in the last 24 hours:

 

Ah yes - the classification of severe as still being able to attend school

"diagnosed with ME/CFS so severe that they are unable to attend school for more than 1 hour a week during the last 6 weeks of the school term)."

Not a clue.
Sadly the way the illness is framed by Crawley et al, the pressure to attend school , the pressure to avoid FII means many children are harmed.
There can't be a lot of choice involved.

 

Presumably that's why GET has morphed into GAT etc?

 

So they stopped recruitment in 2018, had the results in 2019 (1-year follow-up) and have been sitting on them for 5 years, quietly offloading them in an obscure low-impact journal with no press coverage. It's unethical to not publish trial results in a timely fashion.

Also, any GET trials still underway should have participant information sheets updated with this new efficacy and safety information (treatment doesn't work, a quarter of participants get worse) since such information may impact participants' decision whether to take part in the trial.

 

I can't find anything registered in ISRCTN. I guess that's a good thing? :/

eta: But then, there's always FITNET... https://www.isrctn.com/ISRCTN18020851 ... it might be a way they are flying under the radar.

 

Here's the ISRCTN registry entry for MAGENTA - https://www.isrctn.com/ISRCTN23962803

 

How can you have a trial with a single questionnaire as a primary outcome measure and no secondary outcome measures ?
That's not even undergraduate standard .

Note status " no raw data added yet"
Is this another publically funded trial where researchers cherry pick who has access ?

 

In case of interest, the parent of a participant:

 

FITNET got ethics approval in October 2016:

"Ethics approval(s)
Frenchay Research Ethics Committee, 10/10/2016, ref: 16/SW/0268"

"When is the study starting and how long is it expected to run for?
May 2016 to January 2022"



The surveillance study involved patients seen between February 2018 and February 2019.

The surveillance study was discussed at this September 2018 Sub-Committee meeting:

https://s3.eu-west-2.amazonaws.com/...ts/Sub-Committee_Minutes_-_September_2018.pdf

IRAS project ID: 223838
REC reference: 18/SW/0051

from Page 5-6:

"Specific conditions of support (Final)
1. Favourable opinion from a Research Ethics Committee. (Confirmed – issued 20/03/2018)"​

So unless I've misconstrued, the surveillance study received ethics approval in March 2018, which means that FITNET had been approved and was already in progress before the surveillance study. So I don't think that can be a follow-on trial to the surveillance study for severely affected children.

 

https://twitter.com/user/status/1764077702943023556

 

Doesn't stop them including identified severe patients in FITNET though, does it?

Also, a lot of studies are done pre-hoc/post-hoc. Studies that have already been done will get retrospective approval; studies not yet done will get done on the back of a previous study's approval, etc, etc. Remember that whole shenanigans with so-called "service evaluation" that @dave30th uncovered?

But then, how do they get funding, you ask? Well, it gets muddy. Often research funding is sought off the back of studies that are already nearly complete to fund the next few studies. When it's stuff they are already doing in clinic anyway, it probably becomes a lot easier to flex. Things are going to start to unravel when someone has a serious look at the finances, but who is going to be allowed to do that? Or maybe it's all completely fine and above board. Who knows.

 

Indeed. One thing's for sure, it will be interesting to see what Crawley does next (and how much funding she's awarded for doing it).

I see she's getting funding from the Prudence Trust for mental health studies:

https://www.bristol.ac.uk/academic-child-health/grants/

May 2022
Improving adolescent mental health by automating and optimising remote treatment using STTAMP: Sleep Tracking & Treatment for Adolescent Mental health Problems. 1.1 million (including clinical PhD funding). 2022 – 2025. Funder Prudence Trust. Esther Crawley (PI), Co-applicants: Lucy Yardley, John Macleod, Ian Nabney

February 2022
Prudence Trust Early Career Fellowship: £400,000 for adolescent mental health. Crawley E: Commencing summer 2022

November 21
Esther Crawley: Partnership grant with the Prudence Trust: Prevention and Early Intervention of adolescent mental health problems. Lead: Esther Crawley.

 

I’m not aware of any studies – even with all of their methodological flaws – showing any sort of dose response curve. As @Hutan says, the answer is always more trials and/or more therapy. I wonder if there could ever be any data which would lead them to conclude that their therapies [typo corrected] don’t work.

 

Do studies never have to define this?

 

I'd like to know if they're still using GET (or whatever euphemism they're using these days to circumvent the NICE guidelines) in their clinical service after seeing these results.

 

Right, she exempted 11 studies on her own initiative as "service evaluation" when some of them were, and some of them weren't. But she used an ethics committee letter related to a study that had nothing to do with any of them.

However, I would like to give credit for that discovery to a source who figured it out. I just ran with it and used the info to expose Esther's systemic bullshit. This isn't just one study or another--her whole approach to research is shot through with bogus-ness.

 

No.