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

Dolphin

Senior Member
Messages
17,567
Reviewer said:
Line 49: please explain the “established methods” for calculating accelerometer data that you will use, with references.

Crawley et al said:
This feasibility study is determining whether the use of accelerometers is feasible and acceptable; analysis of the accelerometer data is beyond the scope of this feasibility study. The data will be analysed as an outcome measure should the study proceed to a full-scale trial. For the reporting of feasibility studies, detailed analysis plans of the full-scale trial outcomes measures is not necessary. We have now included references to our sentence about using established methods.
I find it frustrating that they would do a trial even if it is only feasibility trial which they won't publish the data which could be useful for others.
 

Dolphin

Senior Member
Messages
17,567
The reviewer grumbles a few times about the PACE Trial. For example:
Reviewer said:
The PACE trial results were very sketchy about what participants did and only mentioned walking as the most common example of aerobic activity undertaken (White et al, 2011)


--

Crawley et al said:
2) A progression of up to 20% is the guidance provided by the National Institute of Clinical Excellence1 and is standard practice in the UK. This is also consistent with the PACE trial, the largest trial done to date. We have now included a reference to NICE guidelines and the PACE trial, the protocol now reads: “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 guidance1 and the PACE trial2)”.


Reviewer said:
The NICE guidelines state that a progression of up to 20% is deemed appropriate for CFS/ME clients. There is no reference in any of the published PACE articles, that I can find, that defines the actual progression. This was one of the many faults of the reporting of this trial. I suggest removing the reference to PACE and using the NICE guideline.


--

Reviewer said:
Vague statements that therapists will administer GET as they would in the NHS settings means nothing to exercise professionals/allied health clinicians who are a) not working in NHS; and 2) work outside the UK but are interested in this project. The many references to the PACE trial may be inappropriate for this project, as the PACE trial has been highly criticised for fundamental flaws in its design and reporting of GET/APT and other outcomes.
 

Dolphin

Senior Member
Messages
17,567
Main Paper said:
Those allocated to this arm 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.
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). This will be the median amount of daily exercise done during the week.
Daily would usually mean 7 days a week although the 2nd mention of "daily" makes this a bit unclear: perhaps it only relates to weekdays.

Even still 5 days in a row of exercise in CFS seems very demanding.
 

Jenny TipsforME

Senior Member
Messages
1,184
Location
Bristol
Interesting to see how this exercise therapist from Australia thinks the UK exercise protocols are not suitable for CFS.
----
Another similar comment from the reviewer:
Another confusing thing is when I looked on public MAGENTA site, the 10-20% increase of activity is for the Activity Management group not mentioned for GET group. Not sure if issue with my brain fog or their write up, but from protocol thought it was GET. It means both groups are being pushed quite hard but the GET gp just focused on physical activity (they don't record all activities like the other group so don't know if exercise at the expense of something else like school work or social life, also seems a flaw for comparison). There's no control group who aren't being pushed to increase activities.
 

Hutan

Senior Member
Messages
1,099
Location
New Zealand
Just listening to Trial by Error on This Week in Virology. David Tuller would be an informed and passionate ally in trying to stop this study, or at least expose it to some critical thinking, Has anyone mentioned it to him?
 

Cheshire

Senior Member
Messages
1,129
Just read that Sir Paul Nurse, a Nobel Prize-winning scientist has been named as the next chancellor of the University of Bristol.
Maybe he should be informed of the appaling scientific level of research lead by Crawley in his own university, and that other Nobel-Prize winners are in the scientific board of the OMF and reject Crawley's psychogenic views.

http://www.bbc.com/news/uk-england-bristol-36758256
 

Hutan

Senior Member
Messages
1,099
Location
New Zealand
Just read that Sir Paul Nurse, a Nobel Prize-winning scientist has been named as the next chancellor of the University of Bristol.
Maybe he should be informed of the appaling scientific level of research lead by Crawley in his own university, and that other Nobel-Prize winners are in the scientific board of the OMF and reject Crawley's psychogenic views.
From Wikipedia:
Nurse has said good scientists must have ... a set of attitudes including mental honesty, self-criticism, open-mindedness and scepticism

He visited Australia last year and was impressive. Great idea @Cheshire.
 

user9876

Senior Member
Messages
4,556
Just read that Sir Paul Nurse, a Nobel Prize-winning scientist has been named as the next chancellor of the University of Bristol.
Maybe he should be informed of the appaling scientific level of research lead by Crawley in his own university, and that other Nobel-Prize winners are in the scientific board of the OMF and reject Crawley's psychogenic views.

http://www.bbc.com/news/uk-england-bristol-36758256


Its worth pointing out that the vice chancellor is the one who runs the university not the chancellor. But it still may be worth trying to contact him. He may even be interested in the type of work that Ron Davis is doing.
 

Jenny TipsforME

Senior Member
Messages
1,184
Location
Bristol
First of all I think we need some clarification on the timescale of the project and specifically what we aim to achieve (general criticism of EC's outlook may come across as personal attack, which would be counterproductive).

It seems like the 1st phase (feasibility) is well under way if not about to finish. How do we find out about plans for future, larger versions? It would seem like better timing to oppose a study before it gets all the other approvals a bit like blocking building planning permission (or to write now giving the reasons further versions would be a bad idea).

In terms of the timing of the protocol publication, is this actually the protocol for the next phase based on the feasibility study? (it doesn't seem that way from the wording). It does seem very odd to agree protocol change that will only be changed on paper but even odder to change just for later participants. Were reviewers unaware of the timing of the trial?

For the future, is there anyway to get alerts about research which is about to start? It is much harder to influence research once it is already underway.
 
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Jenny TipsforME

Senior Member
Messages
1,184
Location
Bristol
Also can we guess when the feasibility study will be published and have a well-evidenced response ready to pass to journalists? Our response would be fairly similar whatever the outcome due to flaws in the research (eg not convinced criteria would have recruited ME/CFS patients, large survey reports harm more likely than benefit).

Has anyone ever worked out if you recruit based just on fatigue what percentage will also happen to meet ICC, Fukuda etc? Would be interesting in terms of comparing with percentage who don't improve with GET. Or what would happen in a comparison using this protocol BUT excluding everyone who meets specific ME/CFS criteria?
 

A.B.

Senior Member
Messages
3,780
The feasibility study is probably also a way to see how "positive" results can be produced with this patient population. It will tell them which outcomes to emphasize at what points in time. FINE and PACE already tell us what to expect in this regard.
 

Hutan

Senior Member
Messages
1,099
Location
New Zealand
Just listening to Trial by Error on This Week in Virology. David Tuller would be an informed and passionate ally in trying to stop this study, or at least expose it to some critical thinking, Has anyone mentioned it to him?

@Kati, Just saw your comment on the TWIV 397 http://www.microbe.tv/twiv/twiv-397/ where Racionella and Tuller chat about the PACE trial. Nice. Great that you mentioned Magenta.
 

Dolphin

Senior Member
Messages
17,567
It seems like the 1st phase (feasibility) is well under way if not about to finish.
Recruitment is due to end in August 2016. But the trial lasts for 12 months for each participant which means it won't end till August 2017. Then it will take time for the data to be analysed. So no immediate rush required it seems.
 

JaimeS

Senior Member
Messages
3,408
Location
Silicon Valley, CA
Sorry, not sure how I missed this alert!

This is likely the best way to communicate as an organised patient voice and not appear to be individuals harassing a researcher. Obviously other UK charities joining forces would be even better.

The idea that we should have to prove we aren't harassing people by asking about a study is laughable and yet all too clearly the case. And frankly, what happens in the UK does NOT stay in the UK, so I think that everyone we can get involved, we should get involved.

I wonder what the experts on the IoM SEID report have to say? It goes against their conclusions after reading all the (inadequate) literature.... There's plenty of reasonable evidence and well qualified people to say that GET on children is irresponsible and unethical.

Definitely a good idea for the scientists' section of the letter, if we can put one together.


I think you're right about timing, eg hold off contacting the UoB engagement twitter account until we have something of weight to report and then comment from an official account. Thinking through the order of actions may be key. We don't just want to let it be known that we are angry in this instance, we want to do something that will actually stop children being subjected to this

As Tuller noted in his interview yesterday, it doesn't appear to matter if you come forward with facts or wielding pitchforks, but I like me some high ground. ;)

You might be right about petitions. The UoB may be surprised at the number of people upset about this. Even if they know something of the controversy it has probably been spun as a minority concern.

Definitively so -- shocking considering the number of signatures on petitions and the like. Clearly not a minority; rather, patients who support PACE, GET, CBT (and they do exist) appear to be in the minority. That's why I think it's so important that we roll this out intelligently, and tweet as we gain signatures. It should be widely known, tweeted, and re-tweeted that a lot of people are concerned.

ME action petition would be better than official parliamentary one as non UK folk can sign?

Absolutely we should make it that anyone can sign. Research in the UK affects everyone. Just look at our CDC guidelines, which naively parrot that "CBT and GET are the most effective treatments available" for CFS. Never mind that only 1 of 4 patients in PACE 'recovered' and that 'recovery' was a joke.

[
Is this in a public bit of PR that their lawyers could trawl through if relevant? It may be prudent to be more discreet? I was shocked to read that lawyers went through our comments to do with freedom of information requests. Feels like a violation but in reality we're publishing our thoughts here for anyone to see.

I do agree, but we will have to mobilize the community, so our thoughts will have to be public to get ppl on board.

-J
 

JaimeS

Senior Member
Messages
3,408
Location
Silicon Valley, CA
So this seems to be showing that there is a better than 1 in 2 chance that any child who takes part in this trial will get worse and only slightly more than 1 in every 5 will see an improvement - all of this on the basis that these figures for adults can be used with children, and who knows if that is true or not?

Very good point.
 

JaimeS

Senior Member
Messages
3,408
Location
Silicon Valley, CA
Another confusing thing is when I looked on public MAGENTA site, the 10-20% increase of activity is for the Activity Management group not mentioned for GET group. Not sure if issue with my brain fog or their write up, but from protocol thought it was GET. It means both groups are being pushed quite hard but the GET gp just focused on physical activity (they don't record all activities like the other group so don't know if exercise at the expense of something else like school work or social life, also seems a flaw for comparison). There's no control group who aren't being pushed to increase activities.

If there were, they would have to say how many people simply spontaneously improved over the length of the trial in this relapsing-remitting illness.

Who needs a control group, anyway? :rolleyes:
 
Messages
12
How are we going to stop this before any children become sicker than they need to be?!

It seems to me that it requires influencing the right people more than making lots of noise. My partner is an academic and she thinks the ethics Committee who have just approved it is probably the best starting point. (What do you think @Keith Geraghty?) They won't be experts on ME, they'll probably just have read the proposal and approved it on its own merits as a self contained document. They should be fairly risk adverse, especially when it comes to children who will have a hard time withdrawing consent if they experience harm. Concerns raised in the peer review will be useful for this, as will the ME Association's survey and patient account of harm.

Could our concerns (to be organised into a letter to the committee) be summed up as:
1) We feel harm from GET is too high a likelihood for a study on children who are unlikely to be able to give properly informed consent and who will probably feel too coerced to be able to leave the trial at any time
2) GET is a treatment in which the majority of patients report harm rather than benefit (Inc various evidence) in conflict with claims made in this proposal
3) For this to be ethical, researchers would need to inform of potential risks to such an extent that it would undermine the study (nocebo effect or difficulties recruiting) see below
4)Similar research has cost a lot of money and produced null or negligible benefit to pwme.
5) This study is a misuse of public research money long term, because the methodology is confused meaning that replication would likely have different results. For example, some people will also have CBT in a fairly haphazard manner. More effort needs to be made to avoid bias in this controversial area, such as analysis from neutral researchers.
6) There are very promising areas of ME which could be invested in (eg...) and patient groups feel that money would be much more productive long term if it was spent on other areas of ME research

Also is this previous thread relevant

BTW this took ages to write so I'm not up to speed on the thread

I need to get in touch with S Campbell please , who wrote this as I need her help with Millions Missing protests on the 27th . I am suggesting this be used in the open conference call , for the central protest demand . Can someone help me get in contact with her please . This is my first time in the forum
 
I need to get in touch with S Campbell please , who wrote this as I need her help with Millions Missing protests on the 27th . I am suggesting this be used in the open conference call , for the central protest demand . Can someone help me get in contact with her please . This is my first time in the forum
Hi @Goldfishliveson and welcome. I'm not aware if @Jenny TipsforME is the same person as you are trying to contact but she will receive a notification as you have quoted her post, depending on her settings she may receive an email to alert her to this.
 

Yogi

Senior Member
Messages
1,132
Information leaflet for parents/carers

http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/MAGENTA PIS Parent OR Carer 17052015 v0.7.pdf


Will my child experience any side effects from taking part in this study? We have used both treatments in our service and we are not aware of side effects. Studies in adults have also not shown that there are any side effects of these two treatments.


I am gobsmacked and can only respond with.

http://giphy.com/gifs/1TBnbnnZeOgs8/
html5http://gph.is/XGW9ZC








LIAR LIAR LIAR LIAR !!!


 
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