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2 Good Letters in the BMJ re PACE

Tom Kindlon

Senior Member
Messages
1,734
My new 1000-word BMJ rapid response (i.e. e-letter) on the £5m PACE Trial, "PACE Trial: Simply giving a reason why an outcome measure was changed is not necessarily sufficient".

It lists all sorts of reasons why I'm unhappy with the changes made to the PACE Trial outcome measures.

I'm afraid I knew it would be too long to get published, so didn't spend as much time on the wording as other letters where I'm hoping they might be published in the print edition.

http://www.bmj.com/content/347/bmj.f5963?tab=responses

Sean Lynch, a psychiatrist, has now responded, approx. 24 hours after my comment went up. Authors get automatic alerts for responses - I wonder whether there might be a connection?

His defence of the changes to the PACE Trial protocol largely seem to depend people trusting him as some sort of expert, perhaps an unbiased expert. There is little substance in them. It's like an appeal to authority.

Sean Lynch was one of the co-authors of the Royal Colleges of Report on CFS (1996) (Word file of this is available here: http://bit.ly/HFQeOM ).
As well as recommending CBT and GET, and little else, it gave very few suggestions for biological research.

He calls for more trials like the PACE Trial.
I feel that there is a need for a new debate now. PACE has in my view made an important contribution to the research evidence and has been a well-designed and conducted trial, but there is a need for further research to build on its contribution in my opinion.
[..]
Pragmatic trials might have advantages of larger sample size and seeing how well the best- evidenced treatments of that time are applied and fare in real world situations and their cost-effectiveness (6).
so that'd be CBT and GET trials and the like.
 
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peggy-sue

Senior Member
Messages
2,623
Location
Scotland
I started this thread on a paper from the BMJ that appeared in my inbox this-morning.
I thought it might be another very relevant reference for criticising PACE...

which is an outstanding example of the use of non-specific composite outcome measures.:thumbsup:;)

As well as that, of particular relevance is the matter of using stringent criteria for diagnosis of subjects.

http://forums.phoenixrising.me/inde...utcome-measures-in-clinical-trials-bmj.26704/
 

Dolphin

Senior Member
Messages
17,567
I started this thread on a paper from the BMJ that appeared in my inbox this-morning.
I thought it might be another very relevant reference for criticising PACE...

which is an outstanding example of the use of non-specific composite outcome measures.:thumbsup:;)

As well as that, of particular relevance is the matter of using stringent criteria for diagnosis of subjects.

http://forums.phoenixrising.me/inde...utcome-measures-in-clinical-trials-bmj.26704/
I've just read the paper. It is mainly that composite measures reduce the likelihood that statistically significant results will be found e.g. if one measures death from all causes, the difference between treated and untreated groups might be small but if one just measures the specific items that are thought to be influenced by a treatment, one might see more dramatic reductions.

So I'm unsure this is relevant for the efficacy measures in the PACE Trial. However, it could be relevant in terms of adverse events.

Also to me it shows why it is important to have a good knowledge of the aetiology and pathophysiology so one knows better what to be measuring.