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

Kitty said:
From @MSEsperanza:

Apologies if that has already been posted—only able to skim but had a quick glance at some references in the paper and saw that at least in one participant-rated outcome measure, the item "minimal change" comprised all three: “a little better” and “a little worse" and "no change".

I wonder if this is thought to be a useful mixture and whether it's being used for other outcome measures in that trial or in other trials as well?

View attachment 21304

Source: Supplementary Table 3. Participant-rated Clinical Global Impression Scale of change in overall health from baseline, for participants allocated to Graded Exercise Therapy (GET) or Activity Management (AM)

https://static-content.springer.com/esm/art:10.1007/s00431-024-05458-x/MediaObjects/431_2024_5458_MOESM1_ESM.docx
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And was there follow up for the drop outs between 6 and 12 months- 26 and 33 people is not insubstantial
 
We stand by our statement that “we have used GET in our service and we are not aware of side effects”. We have used GET (as recommended by NICE) in my specialist paediatric CFS/ME service for nearly a decade. After over a year of running MAGENTA, and careful review of both the qualitative data and independent review by the DSMC, we are even more convinced that children and teenagers are not harmed by GET when delivered by specialist trained therapists as in our service. The qualitative data shows how much children and teenagers in our service enjoy both GET and being involved in a trial.
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There is no evidence of risk to children with CFS/ME. There was no evidence before we started the trial, and now after a successful year of recruitment and follow up, we can confirm that there is no evidence that participants who receive GET are at any increased risk of harm. In fact, our view is that our results to date are reassuring that children not only do not experience harm, but enjoy GET, like being part of a trial and are keen on further research.
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A Crawley clinic patient on Twitter in the last 24 hours:
https://twitter.com/user/status/1764428517406646648

https://twitter.com/user/status/1764429009725587873

https://twitter.com/user/status/1764430061719974134
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Mod note: Noting the content of the remaining tweets in case more disappear:

March 3 2024 Person C
Oh no, I did activity management at the adult Bath clinic and got worse. The OT called it pacing but it was increasing each week. I've still got the worksheets in case there's a court case.

March 4 2024 Person L
Same here back in 2010 at the Child and adolescent clinic that Dr Crawley ran...
It was called pacing, you had to fill in activity diaries, have a baseline, and then increase 20% every week. Except I just got worse & worse and it was 10%, 5%, then nothing. They never said do less
 
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Lucibee said:
The study page is here: https://www.rcpch.ac.uk/work-we-do/...c-fatigue-syndrome-myalgic-encephalitis-cfsme
just looking at it now...

Found it! https://pubmed.ncbi.nlm.nih.gov/36456114/
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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.
 
Physical function between baseline and 6 or 12 months deteriorated by 20 points in 18 of 97 participants (19%) allocated to GET and 24 of 104 par- ticipants (23%) allocated to AM. Four serious adverse events requiring hospital treatment were reported (Supplementary Table 5): one event in each of two participants allocated to AM, two events in one participant allocated to GET. One serious adverse event was possibly related to GET, a psy- chiatric hospital admission due to suicidal ideation. Five participants withdrew from their allocated therapy due to feeling worse, four of 117 (3%) in the GET group and 1/123 (1%) participants in the AM group. There were no additional clinician reports of serious deteriorations in the study par- ticipants. Combining these measures, there was evidence of deterioration (from at least one measure) in 33 out of 123 (27%) of participants in the GET group and 20 out of 117 (17%) participants in the AM group (p = 0.069).
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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.
 
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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 ?
 
Dolphin said:
A Crawley clinic patient on Twitter in the last 24 hours:
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That's very powerful testimony - and of course this is coming from someone who was a child when under Crawley's care
I also got ridiculously anxious and depressed at the time because I was so obsessive about needing to “get it right” so I would recover. I believed them so much that I would, and when I wasn’t getting better thought *I* had failed. So messed up!
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There was no room for fun either. My baseline allocated(at the time)allowed only for eating, washing, brushing hair & teeth, 20mins school work, there was no time to do crafting or anything that bought joy. They said don’t worry,it’ll come when you increase-by then I was too sick
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Lucibee said:
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.
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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.
 
Dx Revision Watch said:
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.
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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.
 
Lucibee said:
Doesn't stop them including identified severe patients in FITNET though, does it?...
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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.
 
Conclusion said:
We did not show a difference between GET and AM, or a substantial improvement in physical function with either intervention. This lack of improvement in physical function may be explained by the low intensity of therapy sessions.
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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.
 
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Lucibee said:
Remember that whole shenanigans with so-called "service evaluation" that @dave30th uncovered?
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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.
 
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