****** !!!!!!!! ****************!!!!!!!!!!!!!!!! Junior version of PACE funded PI Dr Crawley

[JaimeS]

We may merge threads if ppl decide appropriate -- @Sushi ? But there is a follow-up to this located here for now.

 

[Effi]

The MAGENTA study protocol has been published: http://bmjopen.bmj.com/content/6/7/e011255.full?sid=507feb97-e40e-4693-a7ce-74ef3a62f240

 

[Keith Geraghty]

read this and just thought - on no - pACE all over again, just with kids now, then saw that "if patients get depressed or anxious they will be given CBT" - cant for the life of me work out what thats all about. There is so much constructionism in these trials and its hard to keep track - eg specialists who decide this or that, committees, panels, experts, God only knows who these people are and what biases they have. Ofcourse all trials have these sorts of arrangements, but we have all observed with PACE some of the major design biases with these trials. For example, will therapists be more enthusiastic for GET than GAT - who knows, only they do; yet we know therapist effect has a big impact on outcomes. In a centre that promotes CBT and GET its hard to see how such biases cant creep in -- if we are going to do these sorts of trials we certainly need independent people looking, not key proponents of certain dogma. For instance, White's recent study shows CBT useful via computer - whereas a large trial of CBT for depression (what CBT was designed for by Beck) showed no benefit (see Manchester study).

I could go on and on and on - Im just going to keep saying this mantra "the CBT push continues"

£5 million PACE --
£1.2 million FINE - null result
£840k Esther crawley + FINET her study nearly another £1 million NIHR funding
Collin £340k
+ 3 reserach associates

 

[Esther12]

So they're comparing two different forms of graded activity management? In a non-blinded trial relying on self-report outcomes? Have they given up the pretence of doing real research?

edit: Although does look like they're looking at using accelerometers too. Just comparing these two groups in any way seems really odd to me though.

 

[Keith Geraghty]

yes Esther - and throw in that they are offering CBT to all participants at any point - throwing another treatment into the mix - makes you wonder, but Im sure the panels of experts and ethics have considered all this very carefully like they did in the PACE trial -

 

[Yogi]

Is there a way for one or all of the charities to take out an ad and warn parents ?

Excellent point - the charities did a good job of uniting to write to QMUL for the PACE tribunal.

The community and charities need to put a stop to this which can only be described as CHILD ABUSE!!

I really feel for poor unsuspecting children and parents who are misled and forced into this. Many adults who have tried CBT/GET suffered further injury and trauma and for children it will be worse.

How on earth can an ethic committee authorise it given all the scandal around PACE trial?

 

[Bob]

For reference and for searching the forum...

Trial Registry for Trial Feasibility Study:
The MAGENTA trial: can we investigate the effectiveness and cost effectiveness of managed activity compared to graded exercise in teenagers and pre-adolescents.
ISRCTN23962803
Click here to read at BioMed Central.
Click here to read at NHS National Institute for Health Research - UK Clinical Trials Gateway.

Protocol for Trial Feasibility Study:
Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol
Brigden A, Beasant L, Hollingworth W, et al.
BMJ Open 2016;6:e011255.
http://bmjopenbeta.bmj.com/content/6/7/e011255 (full paper)

Protocol for Trial Feasibility Study (identical to the above protocol, but in different publication):
G73(P) The MAGENTA protocol: The feasibility and acceptability of conducting a trial investigating the effectiveness and cost effectiveness of graded exercise therapy compared to activity management for paediatric CFS/ME – a feasibility randomised controlled trial
Brigden A, Beasant L, Hollingworth W, et al.
Arch Dis Child 2016;101:A43
http://adc.bmj.com/content/101/Suppl_1/A43.1


MAGENTA Trial - Forum Threads:
1. ****** !!!!!!!! ****************!!!!!!!!!!!!!!!! Junior version of PACE funded PI Dr Crawley
2. G73(P) The MAGENTA protocol: The feasibility and acceptability of conducting a trial investigating t

.

 

[Kati]

We cannot ignore the timing of this study, as the ME pediatrician, Dr Nigel Speight, is prohibited to speak publicly, to see ME patients or to engage in any activities concerning ME.

Basically this provides a very green light for the psych lobby.

 

[Kalliope]

We cannot ignore the timing of this study, as the ME pediatrician (I forgot his name) is prohibited to speak pubicly, to see ME patients or to engage in any activities concerning ME.

Basically this provided a very green light for the psych lobby.

Nigel Speight

 

[alex3619]

If this goes ahead, and a substantive number of children are made worse, I would like to see the parents, the charities and the patient community unite to ensure that both the ethics committee and the researchers are held responsible. If the ethics committee did their due diligence they would never approve this.

 

[Kati]

Nigel Speight

Thank you I have amended my post

 

[AndyPR]

Somewhat confused by the ME Association highlighting this in the way http://www.meassociation.org.uk/201...dren-and-young-people-with-mecfs-6-july-2016/

I assume this part is the ME Association's analysis;

Strengths and limitations of this study
* This feasibility study is the first trial to investigate graded exercise therapy in children with chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) in the outpatient setting.

* Integrated qualitative methodology is being used to optimise recruitment and retention, and to investigate the feasibility and acceptability of the study processes and interventions.

* This is a multicentre study which will test the feasibility of running this trial in different National Health Service (NHS) settings.

* The participants and clinicians will not be blinded to allocation.

* Participant outcomes are self-reported.

Personally I think that it should be made clearer what EXACTLY is seen as a strength and what is a limitation as I don't believe an average, uneducated (in trial design) layperson would necessarily be able to tell.

As an example, on the ME Association's Facebook feed, someone is using it to tell someone about the existence of "a specialist center in Bath apparently for paediatric cfs/me" which I would interpret as they believe that will be able to help the other person...

 

[Esther12]

I assume this part is the ME Association's analysis;

Nope, that's from the researchers running it.

 

[AndyPR]

Nope, that's from the researchers running it.

Hmm, OK, so the ME Association then are just giving free publicity (and implicit approval) to a trial that could potentially ruin the health of children involved. I hope this was just put up in a hurry and they intend to add some commentary to it at some point.

 

[Esther12]

Hmm, OK, so the ME Association then are just giving free publicity (and implicit approval) to a trial that could potentially ruin the health of children involved. I hope this was just put up in a hurry and they intend to add some commentary to it at some point.

I think that they often just put abstracts up, and it can be helpful to make patients aware of what's been claimed by researchers. In this case I see how it could be confusing though.

 

[eastcoast12]

I didn't read the study but I agree with Kati 100%. If they happen to actually get a few kids with legit cfs/me with their loose criteria, the possibility of destroying a kids life is very real and is tantamount to child abuse. Parents need to be warned. It would be morally incorrect to do nothing. We should try to get all the me/cfs groups to recommend against it and provide evidence of the seriousness of PEM and the possibility that over exertion could lead to symptoms getting worse or even permanent

 

[panckage]

Integrated qualitative methodology is being used to optimise recruitment and retention, and to investigate the feasibility and acceptability of the study processes and interventions.

To me this reads "We are giving out candy for those who will enthusiasticly enter our study and give a positive spin on the treatment surveys"

 

[Snowdrop]

I agree with @AndyPR

It looks like tacit approval from the MEA website and there is no explanation clarifying strength and weaknesses--for non-science people (most people looking for help) this is not at all informative.

 

[charles shepherd]

Somewhat confused by the ME Association highlighting this in the way http://www.meassociation.org.uk/201...dren-and-young-people-with-mecfs-6-july-2016/

I assume this part is the ME Association's analysis;


Personally I think that it should be made clearer what EXACTLY is seen as a strength and what is a limitation as I don't believe an average, uneducated (in trial design) layperson would necessarily be able to tell.

As an example, on the ME Association's Facebook feed, someone is using it to tell someone about the existence of "a specialist center in Bath apparently for paediatric cfs/me" which I would interpret as they believe that will be able to help the other person...

The information was published on the MEA website rolling news service as soon as we received it - as we always try to do

I was responding to questions on the MEA Facebook page right up till midnight last night:

https://www.facebook.com/ME-Association-171411469583186/

People are fee to comment on MEAF and when we discuss CBT, GET etc there are always a wide range of views expressed by our members

I haven't yet had time to read the full paper and ask some questions. I will then comment further.

 

[Keith Geraghty]

£5 million PACE -- highly flawed study but findings of no sig between group benefit at follow up
£1.2 million FINE - null result
£840k Esther Crawley NIHR senior researcher grant + FITNET her study nearly another £1 million NIHR funding
Collin £340k- her research fellow
+ 3 reserach associates
Peter White - another NIHR million testing CBT and NIHR grant for systematic review of treatments for medically unexplained symptoms

(adding this stuff up for just recent UK funded studies and you see the figures being spent on CBT testing in CFS - millions) staggering amounts being pumped into CBT trials - yet the results are mixed to poor and the lack of alternative studies eg false CBT - alternative controls, placebo testing in psychotherapies; but the lack of independence is the most worrying. Crawley is quoting a Dutch study suggesting a 63% recovery rate using CBT in paeds (I find this study flawed) - and has invovled Dutch researchers in her UK CBT trial -- where is the independence ?