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
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)
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.
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).
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).
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.
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
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).
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.
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
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.
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”
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.
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
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
Counterpoint: no.