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

Just saw this on meta-analyses. Have to say I tend to agree!

https://twitter.com/user/status/1040592086742040576

 

I agree but they seemed to be under the impression that this field would still stand without PACE. In a sense it’s a repercussion of our focus on PACE methodology problems- PACE is disregarded as potentially bad science, rather than CBT and GET being disregarded as bad treatment.

Cochrane uses a similar GRADE approach to NICE. A general critique has been that “the Cochrane Collaboration may cause harm by giving credibility to biased studies of vested interests through otherwise respected systematic review” (Ioannidis, 2016). This problem is potentially relevant to any systematic review of ME and CFS studies.

https://www.sciencedirect.com/science/article/pii/S0895435616001475

An issue is studies perceived to be well designed RCTs have high status, but they don’t assess individual studies they focus on overall evidence for a treatment/therapy. I’m guessing this means that they might be very quick in looking at individual trial methodology or perhaps even just the abstract?!

 

I wouldn't assume that they've dropped accelerometers. They might be keeping them in their back pocket as a moderator, or measure of compliance, rather than having them registered as an outcome. That way they can release a positive result with much fan-fare, a null result can be downplayed or ignored.

 

Certainly a possibility. This seems to be the default approach to 'science' by these folks. The most scary thing is they seem to think it is the right way to do it! If the answer does not solve the problem, then restate the problem so it does! @Brian Hughes book covers this lots, and is both fascinating and scary. It's "pantomime science" - would be hilarious if it wasn't for real.

 

I can’t remember but it sounds like we (people at #MEAction) got a very similar response @Adrian

The committee we wrote to is Frenchay based (also in Bristol the city).

Of course we’re just doing detective work at this point, but the latest list of outcomes in this thread had dropped all objective measures except school attendance as a secondary outcome. They shouldn’t really be allowed to reclaim accelerometers just because they throw up a significant result.

 

Oh, sorry. Were they ever listed as an outcome? I thought they'd just not been listed as an outcome, rather than listed and then dropped

 

"
Feasibility analysis will include: the number of
young people eligible, approached and consented to the trial; attrition rate and
treatment adherence; questionnaire and accelerometer completion rates."

"
Quantitative data will include: the number of children who were eligible, approached,
consented and retained in the study; the completeness of questionnaire data at
baseline assessment and follow:up; the percentage of children providing usable
accelerometer data;"

"
We will calculate the proportion of children who wear the accelerometer and provide
usable data. We will assume periods of sixty minutes or more with zero readings as
“non:wear” time. Participant’s data will be included if they provide two or more
weekdays of data with at least 500 minutes of data between 6am and 11pm."

"
In addition to questionnaire measures,
participants in both trial arms will be asked to
wear an accelerometer (GT3X+) to measure physical activity for seven days within
one month of randomisation and at 3 and 6 months follow:up. Accelerometers will be
posted to participants with instructions. Participants will be asked to complete a log
of wear time (time worn and time taken off). Accelerometers are small, match box
sized devices that measure physical activity. They have been shown to provide
reliable indicators of physical activity among children and adults
23
. The accelerometer data will be processed to identify mean minutes of sedentary, light
and moderate to vigorous intensity physical activity per day using established
accelerometer cut off points and protocols
16 24
. The mean accelerometer counts per minute, which provides an indication of the volume of physical activity in which the participant engages, will also be calculated using established methods."

"We will interview children and adolescents and their parents about their use of the accelerometer, whether it is an acceptable device to wear and whether there are particular issues we need to consider in this patient group for the full trial."

 

Thanks, even if they didn't have them as outcome measures in their registration, I'd say that listing them in the 'Clinical Outcome measures' section of the protocol counts: https://bmjopen.bmj.com/content/6/7/e011255.long

 

Is this meaningful in relation to children with ME? There are the problems of the disrupted sleep patterns , such you can even see reversals of normal daily rhythms (ie active at night and sleeping during the day)? It could be that only using data between 6am and 11pm is misleading, especially if there is any intervention that impacts on sleep patterns (either directly or indirectly).

Does 60 minutes of zero readings necessarily equate to non wear time? When I have severe migraines or other extreme pain episodes I find that lying well supported with pillows as motionless as possible is the only thing I can do. I have no idea what would then show up on an accelerometer.

If electronic activity measurement was restricted to only sample periods of the day, it does does not allow for the possibility/probability that participants merely adjust what they do to allow for the increasing demands of a target activity without altering their total activity over a whole day or a whole week.

Having said that, this is irrelevant if they have completely dropped the accelerometer data. However it would seem that they had not really thought it through before the feasibility study.

If children were deliberately fixing their accelerometer results what does this tell us about the children's motives for involvement, their understanding of the experiment and their relationship with the researchers. How had they established that deliberate fixing occurred and what reasons did the children give for it?

If an objective measure was subject to fixing by the subjects, what grounds do we have for assuming that any subjective measures were immune to the same 'cheating'.

It does feel all this is rather a mess.

 

I look forward to someone actually doing some robust research for paediatric ME. Surely it is not beyond the wit of man?

Since we obtained a FITBIT type device, we have gained a valuable insight into fluctuations and exacerbations. Although I am not convinced re absolute accuracy, it provides a relative comparison.

To me a trial that does not include continuous monitoring taking advantage of such devices is stuck in the 20th century.

Perceptions of things are not always accurate- we now know that there is little deep sleep for my daughter, that heart rate can spike at particular times/ with particular activities. Having begun to get the gist of it, thanks to @Keela Too 's blogposts, we are looking forward to aiming for a bit more stability - it is both surprising and fascinating finding out what actually affects heartrate as it is different for everyone.

To not have accelerometer data as an outcome, is for the reasons @Trish highlights, dodgy.
.

 

Notice that, according to this, school attendance data will be obtained "via child self-completed questionnaires". So, once again not using actual school records?

 

But given that there is also the 80% recover " naturally" when looking at essentially " fatigue", that perhaps would undermine a whole lot more? ....

 

In what way does this constitute research.
Is the idea generally that you try and disprove your hypothesis, not go out if your way to reinforce it ?
( Sorry, relatively new to this)

 

https://twitter.com/user/status/1040815680470360064