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

So- they must be collecting all the questionnaire data as part of the feasibility trial if they are planning on including these participants in the full trial....? Which means they have all the outcome measures to look at before the ‘full trial’ technically starts.

 

And who will publish this ?

 

If this description from the trial paperwork is an accurate description of the feasibility study then it would imply the explicit intention to amend the experimental design on the basis of the outcomes of the feasibility study. Surely this means the rolling of the feasibility study into a main study inevitably debars the main study from being prospective research and introduces inherent bias.

 

Maybe the one that published SMILE?

Was it Archives of Diseases of Childhood or similar?

 

If you have convinced yourself that recovery from the health problem under investigation is down to psychological issues, then the mindset seems to be that there is only any need to measure psychological outcomes. So if someone is having trouble steering their car straight, and psychologists only check into the driver's mental state, they are going to miss the possibility the steering wheel is about to fall off. Deliberately don't check for things you don't want to find, else - heaven forbid - you might find them!

 

I guess that any previous discussions on MAGENTA would be on the PR site. The search function does not seem available to me anymore.

Where's @dave30th when we need him?

Probably traveling/preparing for the CMRC conference next week....

 

Does anyone know if they changed the outcome measures for the full MAGENTA trial from those outlined in the feasibility trial? That would be an especially big problem. That's what happened in SMILE--primary and secondary outcomes were swapped based on the feasibility trial findings.

 

Some threads from PR

https://forums.phoenixrising.me/index.php?threads/meaction-petition-stop-get-trials-stop-magenta-pace-for-children-uk-deadline-12th-march.46757/page-11#post-826850

https://forums.phoenixrising.me/index.php?threads/junior-version-of-pace-funded-pi-dr-crawley.42685/

 

MAGENTA trial registration:

http://www.isrctn.com/ISRCTN23962803?q=&filters=conditionCategory:Nervous System Diseases&sort=&offset=6&totalResults=536&page=1&pageSize=10&searchType=basic-search


"Overall trial end date 23/06/2019"

"13/08/2018: The following changes have been made to the trial record: 1. The overall trial end date has been changed from 31/03/2019 to 23/06/2019 2. The recruitment end date has been changed from 07/03/2018 to 23/03/2018 3. The address has been updated 08/08/2018: The overall trial start date has been changed from 10/09/2015 to 15/01/2013. 06/08/2018: Internal review. 22/06/2018: The recruitment start date has been changed from 01/09/2015 to 10/09/2015. This change has been confirmed by the University of Bristol."


"Date assigned: 03/09/2015

Prospectively registered"


So is Crawley again trying to claim her trial was prospectively registered after the trial had started?

Also, it looks like the older version of this registration did not separate the feasibility and full trial in the way that it seems to now: https://web.archive.org/web/20170916160635/http://www.isrctn.com/ISRCTN81456207

What is going on with Crawley's research?

Edit:

"Overall trial start date
15/01/2013"

"Recruitment start date
10/09/2015"

I didn't understand that, so looked up the ISRCTN definition for 'overall trial start date':
"Overall trial start date: A study starts when you begin planning the design of the study and developing the protocol. The overall start date should precede the recruitment start date as the overall study period includes the recruitment period. Please give the anticipated or actual start date for the study in the format dd/mm/yyyy."
Ok - so, the overall trial start date would need to proceed prospective registration of the trial.

The ISRCTN definitions also say:
"Recruitment start date (WHO): The date, or planned date, of recruitment of the first participant to the study. If your study is registered before or on the recruitment start date, it will be listed as 'prospectively registered'. If your study is registered after the recruitment start date, it will be listed as 'retrospectively registered'."
So what's odd about this listing is that it started as the prospective registration of a feasibility study, and then on 27/03/2017 this was morphed into registration for the full study. Should this still count as prospective registration? One could argue that the registration was in place before recruitment began, allowing people to examine the changes to the registration logged on ISRCTN? That seems to defeat a lot of the advantages of prospective registration though as initially these were the only outcomes listed:

Primary outcome measures
Feasibility and acceptability of investigating GET in a randomised controlled trial measured after 1 year.

Secondary outcome measures
N/A

https://web.archive.org/web/20170228024303/http://www.isrctn.com:80/ISRCTN23962803

 

Fixer upper, if you don’t like the results, you can change the data?

Ooops... did I just say that?

 

When was the scoping meeting for NICE relative to these dates ?

 

Scoping meeting was 25 May 2018, 2-4.30.

 

Just flicking thro' this Youtube

https://www.youtube.com/watch?v=w9gLhNO3LIw

(EC at CMRC 2016)
Warning: could make you feel sick, avoid watching while eating.

Is talking re MAGENTA from 15:30. I haven't listened to all of it. Just flicked thro.
At 28.36 ish she says that they have accelerometer data for both arms of the trial.

Was it @JohnTheJack who put in the FOI request for the final trial protocol?

 

And accelerometers data have been dropped ?

 

I think she said that the children 'cheated' so maybe that is her rationale for not using the data(?)
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(?)
Esther Crawley likes to have her cake and eat it me thinks.

 

So the only objective measure is the school attendance records - these were not reported for SMILE ( there may be data protection issues accessing these). Or have I got something wrong- are there exercise records that are not self report?
There are many Fitbit type devices that could have recorded so much more objectively for comparison purposes ( heartrate, sleep etc). Often we perceive a level of sleep that is not accurate.

 

It is the one linked to on the full trial registration:
http://www.isrctn.com/ISRCTN23962803

"
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27377634 "

just spotted an error on the registration:
Overall trial start date
15/01/2013

Overall trial end date
23/06/2019

(just a typo I imagine)

there is a protocol/serial number but I haven't been able to find out what it's used for.
Protocol/serial number
19035

 

I don't know about changed as they were different for the two

but the use of accelerometers now doesn't appear on either (as others have pointed out).
I also noted in reading the info on the main trial that some of the participants will have been offered CBT in addition to whatever they are getting (ie both treatment arms) if it was thought necessary.

It's a complete mess of a trial and trying to unravel it will be a nightmare which is so annoying when we know that it will be hailed as an overall success.

 

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

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’

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.

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).

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.

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?

YES! If children go to these lengths to convince researchers they’d probably have few qualms about fibbing in self report questionnaires. Honestly!