MAGENTA (Managed Activity Graded Exercise iN Teenagers and pre-Adolescents) - Esther Crawley

Amw66 said:
I am slightly confused. I thought the oremise was to compare effectiveness between activity management and GET.
Surely if on the Activity management arm GET should not have been introduced?
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:emoji_rolling_eyes:
Perhaps that'll be so they can say (when there are no differences between treatment arms at long term follow up) "thats because the AM group all went on to have GET" ..... - like they did for PACE... (or was that PACE? perhaps it was one of the other studies iinto CBT/GET?)


@Beckster thanks so much for sharing, very best wishes to you and your daughter

ETA the word 'perhaps'
 
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Sly Saint said:
Results of the feasibility phase of the managed activity graded exercise in teenagers and pre-adolescents (MAGENTA) randomised controlled trial of treatments for chronic fatigue syndrome/myalgic encephalomyelitis
Pilot and Feasibility Studies volume 5, Article number: 151 (2019)

Published: 19 December 2019 (Open access)

https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0525-3
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Having conducted multiple trials of the same thing, it's just bizarre to have a feasibility trial of something that Crawley herself has performed many times pretty much identically. It's been 4 years since initial recruitment. How is it even OK to call something a RCT when it is clearly not properly controlled. Do medical journals simply DGAF anymore?

And you have bizarre stuff like this:
Some participants reported that they could not remember or did not read the information sheet and relied on the fact that their parent(s) had read it:

“I didn’t read it too much but mum did and she looked quite happy with it” (young person, ID29, activity management)
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That's quite the attrition rate:
At six months, of the 35 healthcare resource use and work productivity questionnaires due to be completed, 15 (42.9%) were returned.
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57% did not even return a bunch of questionnaires at 6 months.
To maximise response rate, we reduced and simplified these questionnaires. We removed the adapted healthcare resource use questions and the socioeconomic questions from the baseline questionnaire. We also reduced the level of detail required from participants about their medication use (removing dosage and route of administration), and changing the question from a free text response, to a multiple-choice response (with the option of “other” and free text).
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But they are totally capable of exercising regularly. Somehow this time the accelerometer was not dropped for being too "burdensome", though no data were provided.
All participants started the treatment that they were allocated. Three out of the 40 participants in the activity management arm (7.5%) and three out of the 40 participants in the GET arm (7.5%) discontinued treatment early (defined as discontinuing treatment within six months of randomisation). Participants could indicate more than one reason for discontinuing treatment. Reasons given were the following: preference for the other arm (4), not recovering in the allocated arm (2), deteriorating in the allocated arm (1), not wanting further clinical treatment with the service (1).
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I'm sure there will be a thorough evaluation of that. Absolutely. Very serious stuff.
One participant in the activity management arm crossed over to the GET arm after six months of treatment because of a preference for this treatment.
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What's randomization? Does it matter? About as much as proper controls, I guess.
Some participants reported that the GET programme required them to initially reduce the amount of activity they were doing
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As usual, no exploration of this obvious trade-off will be made.
Recording cognitive activity levels on activity management sheets or the “ActiveME” App was seen as onerous for some, although parents and participants noted that overall activity management had a beneficial effect on their CFS/ME:

“She’s now reading books, she’s now able to cope with watching, you know, something on television that she hasn’t seen before. She’s now coping with maths, – and [name] is much happier I think” (mother, ID51, activity management).
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Recording a few things on an app is too onerous but sure, they can exercise and, *checks note* watch television. Wow! Much improved! There really is no disease here!
During the feasibility phase, Centre One started to offer appointments via Skype so that young people did not have to travel to appointments.
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Travel by car, as a passenger, is too much but, sure, they can totally exercise to the point of being able to watch TV!
The original intention was to provide every participant in the GET arm of the study with a Fitbit to measure their heart rate, but this did not prove feasible because fewer participants than anticipated returned them
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Nevermind, they did drop the actimeters. Good grief, after having done this many times the review panel should be fired for gross incompetence for having approved of this. Zero accountability, ridiculous.
Therefore, the protocol was amended so that clinicians taught young people to manually measure their heart rate. Younger children and those who were unable to measure their heart rate were provided with a Fitbit (subject to availability). This was incorporated into the full trial protocol.
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I'm at loss for words here.
Some participants were keen to be randomised to GET so they could use a Fitbit; “He just wanted the FitBit, that was all he wanted”
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This is serious research funded by serious research institutions approved by serious ethical approval people published in a serious medical journal by serious editors.
Fidelity of intervention said:
Twelve treatment sessions were sampled from Centre One, selecting two sessions from each clinician at random. One session was sampled from Centre Two. Of the 13 sessions rated by clinicians blinded to intervention, all were correctly identified as the allocated treatment.
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In a random sampling, therapists did not mix up rooms or patients. This is "fidelity of intervention". OK.
This study has shown that it is feasible to conduct an RCT investigating the effectiveness and cost-effectiveness of GET compared to activity management
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Too bad "activity management" is not actually an intervention, or a treatment, or anything, really.
As GET is recommended by NICE, an adequately powered trial is necessary to test the effectiveness and cost-effectiveness of GET for young people with CFS/ME
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Counterpoint: no.
 
I can't get excited about reading this stuff on Christmas Eve. But is there any sign that they realise that the feasibility trial has been found out, as a simple cheat? I guess one could argue that it is the proper thing to do to produce a published report even if the research is too poor to mean anything. At least someone might learn from people spending years on a phoney methodology.

Hopefully at least there will not be any more professors of feasibility trialling appointed. And while they about it no more professors of pragmatic trialling.
 
it will be interesting to look at what changes were implemented for the full trial based on the feasibility trial, because I'm assuming they folded in all the feasibility trial participants into the full trial, a la LP study. anyway it's only Christmas Eve early afternoon here.
 
Jonathan Edwards said:
I can't get excited about reading this stuff on Christmas Eve. But is there any sign that they realise that the feasibility trial has been found out, as a simple cheat? I guess one could argue that it is the proper thing to do to produce a published report even if the research is too poor to mean anything. At least someone might learn from people spending years on a phoney methodology.

Hopefully at least there will not be any more professors of feasibility trialling appointed. And while they about it no more professors of pragmatic trialling.
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I wonder if this in the abstract suggests that one site was doubtful
Recruitment, treatment and data collection were not feasible at one centre. The site was withdrawn from the study.
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Brigden 2019 said:
Participants had mixed views on the acceptability of the accelerometer. Some participants didn’t mind wearing it and felt: “No one can see it, um it was very discreet it went under my clothes” (young person, ID9, activity management). Others found it “a bit un-comfy” (young person, ID5, GET) or “itchy” young person, ID72, activity management) and would have liked it to be more discreet; “I struggled a bit to find baggy enough clothes to wear with it” (young person, ID25, GET). Some participants had not told friends about their CFS/ME and the accelerometer raised unwanted questions; “I don’t like people asking questions all the time, about that sort of thing” (young person, ID25, GET) and had the potential to make their condition more visible to others; “So I did get a few odd looks ‘What are you wearing?’” (young person, ID20, GET). Some participants forgot to put the belt back on in the morning, after swimming or a shower; “I often forgot to wear it a few times” (young person, ID29, activity management). Some participants reported that they did not wear the accelerometer if they felt it was not a “typical” week (young person, ID129, activity management). To address these issues, we amended the “Accelerometer information sheet” in July 2016 to encourage participants to wear the accelerometer whether it was perceived as a typical week or not.
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Hmm...
 
So the recruitment rate (±50%) was higher than expected (±25-30%).

The drop-outs were relatively low: 3 out of 40 (7,5%) in both the GET and activity management arm.

The vast majority of patients (155/161) were recruited at centre one, which I assume is Bath. The recruitment site at Cambridge was withdrawn from the study. The authors write that "clinicians were unable to deliver treatment, deliver recruitment calls or collect baseline data according to the protocol" without much information why this was the case.

34 patients were excluded because they were referred to psychological support (I assume this mostly means CBT) at assessment. So it seems that if patients at these recruitment sites are thought to be better off with CBT, that they will not be considered for MAGENTA, which creates selection bias.

There were some problems with the accelerometers not provided data for many participants (41.7% across the three time points) for example because patients did not wear them consistently.

The outcome measure EQ-5D-5 L has been changed to EQ-5D-Y because the latter is more suited for younger populations.

Adverse events will be monitored as follows: "For safety outcomes, we will prospectively collect serious and non-serious adverse events defined as any clinical change or illness reported at clinic or postal follow-up. We will define a serious deterioration in health as: a decrease ≥ 20 in SF-36-PFS or scores of “much” or “very much worse” on the Clinical Global Impression scale; clinician reported serious deterioration in health; or withdrawal from treatment because of feeling worse."
 
MAGENTA remains puzzling to me because the treatments are so much alike. It seems like one form of graded activity versus another that focuses on physical activity. So what exactly is being tested here: whether graded activity should focus on physical activity or not?

They also say they used a checklist of GET elements and activity management elements to check the fidelity of treatment. I would be interested in seeing that checklist, cause what exactly are the differences? The only one I notice is that GET is focused on physical activity rather than all forms of activity.

They mention that both approaches are recommended by NICE but poorly tested in adolescent ME/CFS patients. So why didn't they try to test them first?
 
If this can only be delivered according to protocol at a single site is the protocol not adequately defined/ are staff less engaged with the process ? I thi k more detail is needed for dropping a whole cohort. ( how much does this affect stats?)

I simply don't understand how any child with ME can have friends who are unaware re condition. That alone raises questions.
 
I don't understand why they didn't use both devices (FitBit and ActiveME app) for both groups. It would have been a great way to provide an internal consistency check of activity recording, and would also reduce expectation differences between the groups that might have affected outcomes ("Oh, but I only joined the GET group because I thought I would get a FitBit!" - actually, I bet that's why they found that participants didn't return them - they kept them because they liked them!).

Has anyone here used the ActiveME app? Might it be useful?

As some have said, the groups do seem awfully similar - GET vs GAT. What's next, I wonder? GIT vs GOT?

ISRCTN page seems to indicate that it was the Cambridge centre that dropped out, leaving Bath and Newcastle for the main trial. I expect we'll see the full results sometime next year.
 
Trish said:
There is the same problem with Crawley's FITNET trial - both groups involved increasing activity. There is no control group. The whole thing is meaningless.
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And likely to cause significant harm to at minimum "some" children and adolescents (to my mind "some" is more than "a few" though even a few is too many). My guess would be over half unless they're using mis-diagnosed kids. They are so keen to "prove" that they are right, and have THE answer, that nothing would surprise me any more. Keep the funds flooding in for whatever ideas they have. :mad:
 
Adrian said:
Looking at this website I was reminded of that the ethics information is available (I think we have discussed it before)

http://www.bristol.ac.uk/ccah/resea...ability/chronic-fatigue/magenta-trial/ethics/

Including a letter they wrote to the ethics committee dismissing concerns about PACE. I feel its misleading the ethics committee in that it doesn't represent the issues raised or really address them.

http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Ethics Letter 31.10.16.pdf

It certainly doesn't give a neutral version for the ethics committee to decide on. You couldn't accuse Bristol University of providing all necessary evidence for the ethics committee to use to make a judgement. But then the ethics committee should realize that and dig further. They seem to have done some sort of re-review
http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/15 SW 0124 Confirmation of favourable opinion 24.11.16 (1).pdf

They seem to heavily rely on Cochranes meta analysis in support of doing GET and for arguments of safety. Of course Bristol university doesn't mention to the ethics committee the issues with the Cochrane review and the unreliability of the evidence base that they are using.
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Does anyone know who filed this complaint? I wonder if Crawley's departure has something to do with the fact that MAGENTA did show harm in the end? As well as FITNET-NHS of course.

Is it possible to find out via a FOI request?
 
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