PACE trial TSC and TMG minutes released

JohnTheJack said:
Dieppe is on the dark side. He's into all sorts of quackery:
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Paul Dieppe used to be a quality biomedical scientist and was a close friend of mine in the 1970s. He was a hostage in Kuwait in 1990. Some time after that - maybe 1994, he asked me if I was interested in his chair in Bristol as he was moving into administration. I think something major had changed and I never knew why. He remained a good friend and supported me in 2001 when under fire from peeved colleagues in the US when I stole the limelight at one of their conferences with a front page spread in the Daily Telegraph. I have always thought of him as someone with a good sense of ethics but recently having lost a sense of good scientific method.
 
Jonathan Edwards said:
Paul Dieppe used to be a quality biomedical scientist and was a close friend of mine in the 1970s. He was a hostage in Kuwait in 1990. Some time after that - maybe 1994, he asked me if I was interested in his chair in Bristol as he was moving into administration. I think something major had changed and I never knew why. He remained a good friend and supported me in 2001 when under fire from peeved colleagues in the US when I stole the limelight at one of their conferences with a front page spread in the Daily Telegraph. I have always thought of him as someone with a good sense of ethics but recently having lost a sense of good scientific method.
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Oh right. Didn't mean to be rude about a friend of yours. Perhaps his experience in Kuwait led to a different view of life. It must have been horrific.

I'm not sure why he left PACE. He left the MRC Health Services Research Collaboration in 2007. Looking at his CV, perhaps he left the DMEC when he
became Professor of Health and Wellbeing at the Exeter Medical School.
https://medicine.exeter.ac.uk/people/profile/index.php?web_id=Paul_Dieppe#GQrI3hfu8HEV1ryd.99
 
One further thought on this approval by 'two independent oversight committees'. There was only one member of the DMEC present and there were only four voting members of the TSC at the meeting that approved the changes.

The minutes group TSC members as 'Independent' and 'Non-voting'. I presume that the PIs were voting members and so were grouped under the 'Independent'. If all of them attended, which we cannot know for sure but which would seem likely given the importance of the meeting, then they formed the majority of all those voting on the changes (three out of the four TSC and then one DMEC).

The minutes were written by Sharpe, so it's known he was there and there is reference to the 'PIs' so presumably there was another PI present, so at least half the TSC voting members who approved the changes were the PIs.

In other words they approved their own changes.
 
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Paul Watton said:
The bit of Sonya Chaudhury's message that concerns me greatly is this:



The ME community need to wake up and recognise what it would mean to have people from the CMRC acting as the lead figures in a James Lind Alliance "Priority Setting Partnership" (PSP) for ME/cfs.
In doing so, they could act as enablers for the BPS brigade, allowing them to gain an unwelcome and unwarranted position on the list of research priorities for this illness.

http://www.jla.nihr.ac.uk/about-the-james-lind-alliance/about-psps.htm
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Does anyone have any updates on this - the James Lind Alliance PSP?
 
It was mentioned in an interview that Mark Taylor gave at the Cochrane UK conference in UK, Sep 2018:

(@MTaylorOxford), Head of Impact for the Central Commissioning Facility of the National Institute for Health Research, about research impact, his own experience of multiple sclerosis and how Cochrane can involve patients in their work.

"So NIHR has spent a lot of time and effort on patient involvement. Simon Denegri and Zoë Gray at INVOLVE (www.invo.org.uk) do an awful lot of work on this and Simon, particularly, is a real figurehead in this area. We have the James Lind Alliance (www.jla.nihr.ac.uk) to get the patient viewpoint in prioritizing what sort of research that we do. There’s a lot of work that will continue in that but I think when it comes to working out what the impact is, we need to ask the patients again. What do they think success looks like, for them? Taking into account, as you say, on average, and it is a very broad average, it’s seventeen years for research to get into practice, do we need to ask patients earlier on, well what do they think? What would they hope for, if the research were successful in terms of their pathway?"

Whole blog: http://www.evidentlycochrane.net/96...09_41&utm_medium=email&utm_term=0_fcb014eb5d-

So it seems as if the James Lind PSP can be significant in influencing focus of research at NIHR
 
Just having a brain freeze: can anyone remind me where it was said that they changed the recovery thresholds so they were more in line with other studies? Thanks!
 
Gecko said:
Just having a brain freeze: can anyone remind me where it was said that they changed the recovery thresholds so they were more in line with other studies? Thanks!
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I think it was this commenary: Sharpe et al. (2017) Do more people recover from chronic fatigue syndrome with cognitive behaviour therapy or graded exercise therapy than with other treatments? https://www.tandfonline.com/doi/abs/10.1080/21641846.2017.1288629

Where they write: "a review of the published literature indicates that other studies, including those that used more stringent criteria, report recovery estimates closer to the ones we reported than to those reported by Wilshire et al."
 
Gecko said:
Just having a brain freeze: can anyone remind me where it was said that they changed the recovery thresholds so they were more in line with other studies? Thanks!
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Also here:
https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-019-0288-x

From that article:
article said:
We prefer the definitions of recovery we used to those used by Wilshire et al. as they give absolute rates more consistent both with the literature, and with our clinical experience. We also note that, even in Wilshire et al.’s analysis, the relative rate of recovery with CBT and GET was approximately twice that with APT and SMC alone.
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Woolie said:
From that article:
article said:
We also note that, even in Wilshire et al.’s analysis, the relative rate of recovery with CBT and GET was approximately twice that with APT and SMC alone.
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Surely it's a complete nonsense to place any significance on A being twice B if A and B are not statistically significantly different. How did they get away with saying that?
 
BruceInOz said:
Surely it's a complete nonsense to place any significance on A being twice B if A and B are not statistically significantly different. How did they get away with saying that?
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God only knows! Obviously, not a peer reviewed document (but they've said equally stupid things in reviewed articles. I guess if you get other, like-minded idiots to review them, you can get away with anything. After all, the details don't matter, because we "know" CBT and GET work).
 
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Snow Leopard said:
It is quite clear they knew their results were going to be crap (reports from therapists and the FINE trial having null results) and that is why they reduced the analysis thresholds to what is basically the minimum possible change on questionnaires.

There is no other reason why they would suddenly decide to radically change their analysis strategy when they had already acquired 99-100% of the data.
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Do we even know exactly when they did decide to make such substantial changes? I've seen other people say it seemed that they had been rather slipped through without a big announcement that a major re-think was being implemented - I don't remember much in these minutes, but keep realising I've forgotten bits I've read. We need the minutes of the Analysis Strategy Group and Writing and publication oversight committee (WAPOC)!

From minutes: 20090429 TSC.pdf 29th April 2009

There are points about playing with how to present dummy data in there.

Point 9 said FINE would be presenting results on the 13th May [2009]. XXXXX will be presenting the [FINE] results on the PACE team day in June. (Their fun team building ‘away day’?). Before they knew it was null result that suggested updating PACE participants and doctors on FINE results via a newsletter - did that ever happen, or do they only like to keep people informed about 'positive news'?

The PACE statistical analysis plan says: “These planned analyses were written with a view to publication and are reproduced almost as they were approved by the Trial Steering Committee (Version 1.2 dated 2 May 2010)”. That's quite a while after they knew about the FINE trial's results.
 
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