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

https://bmjopen.bmj.com/content/6/7/e011255

"
Study design
This study started in September 2015 and recruitment is expected to finish in August 2016. This is a feasibility RCT with integrated qualitative methods."

"
Ethical considerations
GET, CBT and activity management are recommended as treatments in NICE guidance for CFS/ME;5 however, there is no evidence that GET is effective or safe in children and adolescents."

"
At 12 months, we will assess whether the trial should continue to a full trial. The full trial is unlikely to be feasible in the format considered here if any of the following apply:

1. Less than 70 children and adolescents have been recruited (∼70% of the target) and if the qualitative data collected suggest that recruitment cannot be improved any further.
   
   
2. The 6-month follow-up is <80% and if the qualitative data suggest that follow-up rates cannot be improved any further.
   
   
3. Data suggest the interventions are not acceptable to children and/or their parents.
   
   
4. If the Data and Safety Monitoring Committee (DSMC) and the Trial Steering Committee (TSC) recommend the trial is stopped for safety reasons."

"
Public and patient involvement
A Patient Advisory Group (PAG) has been involved throughout the development of this protocol and will remain involved throughout the running of the trial, with PAG meetings being held every 6 months. Minutes from the PAG group will be disseminated to the Study Steering Committee and the Trial Management Group."

Anyone know anything about the PAG on this trial?

Has this been turned into a full trial ?

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

When is the study starting and how long is it expected to run for?
September 2015 to March 2019

does this mean the feasibility study has been rolled into the full one?

eta2:
yes
Favourable ethical opinion to amend from feasibility to full trial: NRES Committee South West - Frenchay, 06/03/2017, ref: 15/SW/0124

The overall trial end date has been updated from 31/12/2018 to 31/03/2019 3. The target number of participants has been updated from 100 to 222 (this includes the 100 participants from the feasibility trial).

eta3:
Have the MPs who took part in the Westminster debate been made aware of this trial?

MAGENTA website:
http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/magenta-trial/

eta4:
The version of the feasibility study I posted in the OP first link was updated in July 2016.
The previous version is here:
https://bmjopen.bmj.com/content/bmjopen/6/7/e011255.draft-revisions.pdf
and the reviewer (just the one) comments here:
https://bmjopen.bmj.com/content/bmjopen/6/7/e011255.reviewer-comments.pdf

 

August 2017(?)

so did the feasibility trial start early? ie March 2016?

eta:
or did EC go for full trial permission after 6 months? (ie the first follow-up of the feasibility trial, therefore it did not run for a year as initially intended?)

eta2:
for full study it says
Recruitment end date
07/03/2018

 

That's not necessarily a problem, so long as they've not used the feasibility to change outcomes, and are entirely open about what they're doing.

 

Well, times are changing. No playing or going outside today? Or does Mrs Crawley not consider that as part of childhood?

 

I can't believe that, after all, there is a GET trial again, this time they are destroying childrens' lives. This really touches me in a negative sense. It's incredible. Can't there nothing be done to stop this lunacy?

 

And don’t forget the GET arm is “by referral” so presumably that means they can cherry pick the sample

 

I don' t know how genuine volunteers are. From the other place there were posts indicating that parents were being " hassled" to join the trial. Phonecalls every 30 mins.
With ever present PRS diagnosis should your child slip backwards it' s Hobson's choice.

Somehow this Kafkaesque nightmare has no traction here - we protest at refugees and Trump separating parents and children, yet have no mainstream knowledge of what goes on behind twitching curtains here ..

 

I am unable to read any of the description or links but it is legal for doctors to harm patients with quackery in the UK?

 

Some thoughts on this

http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/magenta-trial/

Ineffective treatments appear effective mainly due to reporting biases and regression to the mean. This study fails to control both of these factors.

The design of the GET intervention is also susceptible to activity displacement (sacrificing activity in one area to increase activity in another area).

A target of thirty minutes of exercise a day makes me question the CFS diagnosis.

Accelerometers will be used to record activity at 0, 3, 6 months. The primary outcome is self reported physical function however, so in my view the study still fails to control for biased self reporting. It will be interesting to see whether the accelerometer data supports or contradicts self reported measures.

Since regression to the mean isn't controlled for, it will be technically impossible to attribute any improvement to the interventions. The study authors are probably operating under he assumption that the efficacy of the intervention has already been proven in previous studies. My memory is hazy on this but I doubt that this is really the case, most likely, previous studied based claims of efficacy on weak design susceptible to bias.

Due to failing to control for regression to the mean, a positive outcome is very likely. Crawley's clinic probably offers both kinds of treatments, or could easily switch to whichever comes out on top. As usual with CBT/GET, it's about defending business interests rather than finding out what treatments really work.

 

Reading all this is so disheartening. I had begun to think that we might be moving beyond this. And then here she comes again. How are they getting the young people for this study. I feel sorry for them, their parents and for all of us. There is huge manipulation going on and it is very intentional... A kafkaesque nightmare is an apt description.

 

Very disturbing stuff.

All we can do is keep pointing it out, and document everything so eventually this despicable behaviour can be held to account.

 

I have not studied this in detail but from what I can see this is another unblinded trial with subjective outcome measures that will provide no useful information.

Additional serious concerns have been identified with the SMILE study. Bristol University legal department is well aware of the fact that people have concerns, as is the BMJ. These studies on children have been generated on the back of adult studies like PACE using similarly flawed methods. There may be some hope that the message may be finally getting through that studies like this are not justified. If not I am not sure quite what more should be done to shift opinion but on the other hand it will be increasingly difficult for bristol to maintain the credibility of these studies as PACE collapses.

The whole business of doing feasibility studies that are rolled into full studies looks to me problematic and against the basic rule that you set things up prospectively and do not fiddle with them half way through. There is a strong suspicion that it is perceived that 'feasibility studies' are easier to get ethical approval for.

I would be interested to know if Dr Crawley is the only person worldwide to be doing studies of therapist-delivered treatments in childhood ME. And whether the rest of the world is following her results.

 

As FITNET is a follow up of a Dutch study ( taken apart by @Docsimsim & Vink ) , I suspect that where the BPS model is alive and well, that you will find paediatric research.

 

It would be interesting to know if the Dutch are still setting up studies.

And indeed whether Chalder has the face to set up further studies now.

 

I don't think extending a feasibility trial into a full trial is a problem per se--the problem in SMILE was that the two-person subcommittee responding to the request to extend it also allowed Professor Crawley to swap primary sound secondary outcome measures at the same time--a move virtually guaranteed to create bias. I do think the concerns that have been raised about SMILE and about the school absence study have put Bristol and Professor Crawley on notice that people are now aware of this sort of data manipulation--ok, let's call it research misconduct. MAGENTA was set up and approved before all the recent PACE/CBT/GET debunking.