I agree with the never assume anything. The quality of the result may of course depend on the quality of the experts. But this is where I would also expect an statistician (or data scientist) to ask questions - for example with the CFQ asking exactly what properties it has in terms of measuring...
I think there is a difference between expecting a statistician to know about effects and to have a deep working knowledge of the psychology of the effects. Coming from a slightly different angle when doing data analysis (and machine learning) the people doing it always like to have a subject...
I think too many statisticians follow recipes and forget about the limitation of techniques. Sometimes (or often) they seem to simply assume things like Gaussian error in readings and hence apply standard techniques. Or assume the techniques are robust if the assumptions aren't quite true. I've...
I suspect they are well aware of this and see it as a way of getting easy approval.
It is concerning that people who clearly don't know what they are doing are making such big approvals. In this case basically for a new trial but including results from people in a different trial.
One of the joint heads of this unit Prof Chris Metcalfe is an author in the Magenta and Fitnet protocols.
So there expertise in allowing meaningless trials (where the outcome measures have no value). Its not clear if he knows about the issues with switching from a feasibility study to a full...
One of the committee has a page here:
https://www.alignbodyclinic.co.uk/jay-ruddock
He doesn't appear to have research experience beyond being involved in a systematic review in 2016. But he is helping train people for ethics committees which I find worrying and he is known for his 'magic' touch.
In terms of ethics permission in the response from the ethics committee on 29 January 2016 for an unpublished amendment request from 18th Nov 2015
http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Substanital%20Amendment%201.%2018112015%20Letter%20of%20Approval.pdf
They ethics...
In a letter to the ethics committee who approved Magenta
http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Ethics%20Letter%2031.10.16.pdf
Crawley writes:
Yet the cochrane review says:
and
So although Crawley makes claims to the ethics committee that Cochrane 'looked...
They appear to have incorporated these changes in when they made it a full trial in 2017. Including the use of 100 patients from the feasibility study. So it looks like they were added in March 2017 but they are vague.
As far as I can tell the published trial protocol is for the feasibility...
I think that is one of the reasons to have them for the whole period of the trial. Even if they use slightly less accurate devices. Something like a fitbit is small (much smaller than a matchbox) and some people seem to wear them all the time.
The reviewers are pointing out that the protocol does not actually define what treatment is being provided. Yet the trial seemed to have started recruiting in 2015 and these reviews are in 2016 so they are basically operating for some of the time on a protocol that the reviews were saying didn't...
I think that one of their big issues is that they seem to have no quality control between the groups so if some group or individuals are producing reviews that are rubbish (like the GET one which even has outcome switching) then no one else in the cochrane organization seems to notice/care/hold...
Have you seen the post PACE reanalysis letter that bristol sent to the ethics committee and then the ethics committee gave them a clean bill of health. I think they ethics committee were mislead by bristol. The Cochrane review is bad as Bob and Tom pointed out to them. But they appear to have no...
Just dropping the measure when they are continuing the trial seems dodgy to me. This should be seen as a mid way assessment and change in outcomes measured rather than a feasibility study and then a new full trial. They are pulling data from the feasibility study into the full trial (as they did...
PACE is a big contributer to the Cochrane data in the meta analysis and one of the few with harms data.
Also much of the criticism of pace applies to other data in the Cochrane meta analysis in terms of the subjective outcomes in open label trials and the outcome switching (in the Cochrane meta...
It seems to me that they cannot then claim that analysis happened before data was unblinded (to the stats team) it also suggests any deviations from the protocol outcome measures could come as a result of knowledge of the data. If they were doing this all the way through it could be dodgy but I...
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