I’m just reading this thread through to contribute to the #MEAction response. (This is my personal response and maybe quite different from what ends up coming from #MEAction UK)
I notice this ISRCTN version
Group 1: Activity management (AM) will be delivered by CFS/ME specialists that are not physiotherapists (occupational therapists, nurses, psychologists). Therapists will receive guidance on the Mandatory, Prohibited and Flexible components. Activity management aims to convert a “boom-bust” pattern of activity (lots one day and little the next) to a baseline with the same daily amount. For children/teenagers with CFS/ME these are almost entirely cognitive activities: school, school work, reading.
Group 2: Graded Exercise Therapy (GET) will be delivered by referral to a GET-trained specialist CFS/ME physiotherapist who will receive guidance on the Mandatory, Prohibited and Flexible components. Children will be offered advice that is focused on exercise with detailed assessment of current physical activity, advice about exercise and a programme including timed daily exercise. Children will be asked to record the amount of exercise and taught to use a heart rate monitor with target heart rates.
http://www.isrctn.com/ISRCTN23962803?q=&filters=conditionCategory:Nervous System Diseases&sort=&offset=6&totalResults=536&page=1&pageSize=10&searchType=basic-search
Is different from the BMJ version
about the Activity Management ‘control group’
“Activity management aims to convert a ‘boom–bust’ pattern of activity (lots 1 day and little the next) to a baseline with the same daily amount before increasing the daily amount by 10–20% each week”
(This is the GET condition) “The intervention will encourage children and adolescents to find a baseline level of exercise which will be increased slowly (by 10–20% a week, as per NICE guidance5 and the Pacing, graded Activity and Cognitive behaviour therapy – a randomised Evaluation (PACE)12 ,21).“
which
@Trish quoted at the start of the thread
The ISRCTN leaves out the push to increase activity on a weekly basis! Probably not accidentally? Can we assume both groups are still increasing activity or is this another change in the protocol?
I agree with Trish that the two groups/conditions are a key issue. It is actually a good in a way that they included a comparison group which is almost the same (this is an improvement on most of the GET/CBT research in the sense that it’s possible to compare something specific).
In this case all you can tell is -
does structured increase in exercise improve perceived health better than unspecified, structured increase in activity?
If they have the self control to not over claim beyond this, to some extent this could be ok if they had done it well.
However, they could make properly useful claims if they had included a no intervention control group as well. They must know that patient orgs would be opposed to the structured increase in activity aspects of it - we don’t particularly differentiate between pressure to increase walking by 10-20% a week and pressure to attend more school by 10-20% a week.
Young people with ME do tend to improve. Would no input or Pacing have provided much better outcomes?
This study is meaningless in terms of counteracting the nature of the criticism they receive.
Also the difference between the groups isn’t well controlled in the details- AM increase in activity can include walking and PE which is really specifically GET
Some AM children might only be increasing exercise but I don’t think we’d know which. It would have made more sense to have one group increase cognitive activity and the other exercise (not that I think either is ethical).
The cynical side of me agrees with whoever said that it’s win win for the Centres - one or other condition will come out top and they’re the ones positioned to deliver either regime.
The benefit-of-the-doubt side of me thinks this is likely to do with perceived ethics. They think increasing activity for ME is in the best interests of the children. To withhold treatment would be regarded as unethical, so the only options are two versions they believe in.
MAGENTA was set up and approved before all the recent PACE/CBT/GET debunking.
Yes because our MAGENTA inspired #stopGET petitions were written when we didn’t have PACE data. Though when we wrote to the ethics committee a bit later with our concerns they justified MAGENTA based on Cochrane rather than PACE (ie criticism of PACE is irrelevant).
100 patients in a feasibility study looks very odd to me.
having recruited a lot of patients you might then not know if there were any more ready to volunteer and be back in the same situation.
The feasibility stuff is odd. From an advocacy perspective I wonder if we’d lose people though? It seems like different criticisms are worth raising for different audiences.
Primary outcome measure
Feasibility trial:
Feasibility and acceptability of investigating GET in a randomised controlled trial measured after 1 year.
Full trial:
Physical function is measured with the 36-Item Short Form Health Survey (SF36, physical function sub scale), collected at the 6 month time point.
Full trial:
1. School attendance is measured as percentage attendance of expected sessions
2. Fatigue is measured using the Chalder Fatigue score
3. Pain is measured using the visual analogue scale
4. Depression and anxiety are measured using the Spence Children’s Anxiety Scale (SCAS) and the Hospital Anxiety and Depression Scale (HADS, if they are 12-17 years old)
5. Health related quality of life is measured using the EQ-5D-Y
So we have already lost the accelerometers?! School attendance is something but you can be pressured to go to school when you’re too ill to learn anything (my sister was under a lot of pressure to attend school when she was too sick for this to be a sensible plan).
Technically the success of an intervention isn’t relevant to whether it is feasible. But in this case they must have recorded the Full Trial outcomes in the feasibility stage. If accelerometers have been now dropped, can we FOI the feasibility trial accelerometer results? Or if the children faked them, is this unhelpful for us to know?
This might imply that they were trying to show they were doing exercise when they weren't(?)
Why would they do that I wonder
; trying to 'please' the therapist(?), because they couldn't do what was being asked(?)
And yet their answers to the questionnaires are perfectly sound(?)
YES! If children go to these lengths to convince researchers they’d probably have few qualms about fibbing in self report questionnaires. Honestly!
