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

I'm posting this 2016 letter from Prof Crawley, on behalf of the MAGENTA team, to the REC, as some may not have previously seen it in earlier threads:

https://dxrevisionwatch.files.wordpress.com/2024/03/ethics-letter-31.10.16.pdf

Centre for Child & Adolescent Health
Oakfield House
Clifton BS8 2BN
Tel: 0117 331 4085
http://www.bristol.ac.uk/ccah/


Dear Natasha

RE: 15 SW 0124. The MAGENTA Trial

Thank you for offering me, on behalf of the MAGENTA team, the opportunity to address these concerns. I have addressed each issue in turn and I have also enclosed copies of the relevant publications.

The REC is probably aware that there are always campaigns against CFS/ME research, particularly research into behavioural approaches to treatment. These have been well described in both the scientific and lay press and are alluded to by the complainant. The current campaigns are focussed on treatment trials but also extend into biological research. There is currently a campaign against the MAGENTA trial and I have therefore provided a summary (appendix 1) of what has happened to date with this campaign.

My patients and participants in MAGENTA want research and want access to the full range of treatment options. This is reflected in the consistently high recruitment and retention rates we have experienced with MAGENTA. As you know, we included integrated qualitative studies in MAGENTA and we asked participants and their parents about both the trial and their views on graded exercise therapy (GET). Patients and participants like GET and want to be able to have it. They also want more research and want to be involved in trials...


Full letter addressing a number of complaints from an unidentified complainant here:
https://dxrevisionwatch.files.wordpress.com/2024/03/ethics-letter-31.10.16.pdf


I'm sorry I don't have time to go through it and quote important responses Crawley had made to the REC in response to the complaints.

ETA: "appendix 1" - is not included in the PDF.
 
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Dx Revision Watch said:
Full letter addressing a number of complaints from an unidentified complainant here:
https://dxrevisionwatch.files.wordpress.com/2024/03/ethics-letter-31.10.16.pdf
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Crawley in her 2016 letter makes several audacious statements about lack of any side effects:

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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The letter sounds even more sinister in hindsight now that we have the results. I doubt those 27% of participants who ended up harmed by GET in MAGENTA enjoyed it.
 
Dx Revision Watch said:
Patients and participants like GET and want to be able to have it. They also want more research and want to be involved in trials...
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Despite Crawley’s long standing PAG that supports her work, at least since 2016 it is getting harder to argue this, given the various patient surveys, the new NICE guidelines findings, the 60 or so patient groups signing our letter requesting the withdrawal of the Cochrane Exercise Review advocating GET and as @Sid points out the Magenta results themselves.

Obviously there is also the historic issue of the dangers of arguing with Prof Crawley as experienced by those getting on the wrong end of child protection investigations when objecting to GET.
 
Dx Revision Watch said:
Do we know what happened about a potential trial for children with severe ME/CFS other than this preliminary study: https://www.rcpch.ac.uk/sites/default/files/2019-02/protocolcard_cfs_04022019.pdf

Duration February 2019 to February 2020 (inclusive). Follow-up until February 2021 (1 year follow-up).
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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/
 
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?

Screenshot 2024-03-04 at 15.28.11.png

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...-x/MediaObjects/431_2024_5458_MOESM1_ESM.docx
 
Sean said:
Indeed. How come that is not setting off alarm bells?
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Something something "hurt doesn't mean harm".

The bigger ethical problem with the ideology is that it makes it impossible to assess harms, since all harms are assumed to be benign, if not impossible. So it's not falsifiable, therefore not scientific, and reports of harms cannot be taken seriously. But any improvement is hailed as a success and positive evidence. Basically it's as complete madness as can be invented, and it dominates our lives. Sick stuff, pure banality of evil.
 
Esther Crawley said:
The current campaigns are focussed on treatment trials but also extend into biological research
Click to expand...
The ease with which these people lie is genuinely impressive. They have absolute contempt for the truth and their own patients. It's like the stuff you hear out of hate-focused radio shows or podcasts, they'll simply say anything to push their agenda.

Almost all of the real research is only happening because of the patients either pushing for it or funding it. And she dares say that. What absolute crassness.
 
rvallee said:
Something something "hurt doesn't mean harm".

The bigger ethical problem with the ideology is that it makes it impossible to assess harms, since all harms are assumed to be benign, if not impossible. So it's not falsifiable, therefore not scientific, and reports of harms cannot be taken seriously. But any improvement is hailed as a success and positive evidence. Basically it's as complete madness as can be invented, and it dominates our lives. Sick stuff, pure banality of evil.
Click to expand...
I agree with everything except for the ‘madness’, it’s cruel manipulation but that’s not related to sanity. They simply need to do whatever serves themselves best, that’s priority.
 
rvallee said:
The ease with which these people lie is genuinely impressive. They have absolute contempt for the truth and their own patients. It's like the stuff you hear out of hate-focused radio shows or podcasts, they'll simply say anything to push their agenda.

Almost all of the real research is only happening because of the patients either pushing for it or funding it. And she dares say that. What absolute crassness.
Click to expand...

It is just like the stuff you hear on there indeed.
 
Trish said:
The GET design looks like it's straight from the PACE GET manuals
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I am reminded of the comments made by a NICE committee member with a link to Bristol in response to my witness statement on trial problems. It was pointed out that GET as in PACE was no longer used so PACE could be ignored (maybe not a good tactical point to make). It was also pointed out that the superiority of newer methods that did not use fixed increment GET was evident to professionals in the context of service delivery (we know it works).

I am not sure of the time lines but I think Magenta was in progress at that time?
 
From @Dx Revision Watch post re patient/parent info- Activity management -
"It will also include the amount of time spent doing physical activity such as walking or PE but we will not ask for any detail of exercise or for this to be recorded separately."

How does this work - surely its better to know the effects of various types of physical exercise as part of an overall energy envelope- its an intrinsic part of avoiding PEM. Heart rate monitoring to try and suss out baseline as part of everyday life would have been invaluable ( and no doubt illuminating) not just for exercise group.

Lipservice/ malpractice/service perpetuation design.....
 
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