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Jonathan Edwards: PACE team response shows a disregard for the principles of science

Cheesus

Senior Member
Messages
1,292
Location
UK
Abstract
The PACE trial of cognitive behavioural therapy and graded exercise therapy for chronic fatigue syndrome/myalgic encephalomyelitis has raised serious questions about research methodology. An editorial article by Geraghty gives a fair account of the problems involved, if anything understating the case. The response by White et al. fails to address the key design flaw, of an unblinded study with subjective outcome measures, apparently demonstrating a lack of understanding of basic trial design requirements. The failure of the academic community to recognise the weakness of trials of this type suggests that a major overhaul of quality control is needed.

http://journals.sagepub.com/doi/full/10.1177/1359105317700886
 
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Cheesus

Senior Member
Messages
1,292
Location
UK
This is my favourite part:

In my experience, most of the people with a deep understanding of the scientific questions associated with CFS/ME are patients or carers. To suggest that when these people voice their opinions they are doing a disservice to their peers seems to me inexcusable.

I'd like to think that Phoenix Rising has had something of a positive impact on our resident rheumatologist!

Thank you very much for writing this and all your support for patients with ME, @Jonathan Edwards!
 
Messages
13,774
Read it, loved it. Especially the intro, where a bit of personal story (the sort of thing which normally annoys me) did a good job of setting the scene:

Some years ago I was asked to advise on research strategies for chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME), on the grounds of having expertise that might be relevant, although I never practiced in the field. I was introduced to the PACE study in 2014 by a presentation by Peter White that consisted of a cursory showing of one or two data images intended to assure the audience of robust evidence for efficacy of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), followed by an extended series of unsupported statements directed at patient advocates who were accused of ‘attacking science’ by raising criticisms of the trial. Subsequent interaction with the patient community made it clear to me that the advocates’ criticisms were, if anything, over-lenient and that if there was any threat to science it came from the poor quality of the study itself.

I did wonder if it would have been worth mentioning the trial's poor results for their objective outcomes?

Thanks a lot to @Jonathan Edwards for standing up for patients on this, and all his work on PACE advocacy. Slowly... making... progress...
 
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Messages
2,158
Has anyone got access to a copy of Simon Wessely and Brian Everitt's 'Clinical Trials in Psychiatry'.
I refuse to waste £80 on it, and being housebound don't have access to a University library.

I'd be interested to know whether they point out the unscientific nature of unblinded trials with subjective outcome measures. (or any of the other flaws like conflicts of interest, changing recovery criteria etc)

If so, Wessely himself has condemned PACE before it started.

If not, he clearly doesn't understand science. This would help to explain why so many appallingly bad papers are published about ME by psychiatrists and psychologists, and also explain the well known crisis of replicability of psychological research.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
I had no idea Wessely had actually written a book on clinical trial methodology!

Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read…it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY

"The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications… an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE

Reading between the lines of both comments is interesting. I guess overcoming snags is how to get round the fact you cannot do a trial that way. I can hear the editorial board of BJP going for it big time - 'you can do it that way cos they say so'.

A very pragmatic approach might I suppose mean not worrying too much about theory but just getting on with it even if you have no idea of methodological principles.

Oh your majesty, how your clothes do shimmer, or at least everyone says they do.
 

Cheesus

Senior Member
Messages
1,292
Location
UK
Has anyone got access to a copy of Simon Wessely and Brian Everitt's 'Clinical Trials in Psychiatry'.
I refuse to waste £80 on it, and being housebound don't have access to a University library.

I'd be interested to know whether they point out the unscientific nature of unblinded trials with subjective outcome measures. (or any of the other flaws like conflicts of interest, changing recovery criteria etc)

If so, Wessely himself has condemned PACE before it started.

If not, he clearly doesn't understand science. This would help to explain why so many appallingly bad papers are published about ME by psychiatrists and psychologists, and also explain the well known crisis of replicability of psychological research.

I just found this at the bottom of one of Wessely's papers on trial methodology:

I began with a quote and I end with one. It is from Richard Horton, the editor of The Lancet, who, although offering a critical look at modern trials, nevertheless conveys the continuing central importance of the randomized trial in promoting better health care:

"All health-care professionals directly or peripherally involved in clinical trials need to recommit themselves to explaining, proselytising, promoting, understanding, encouraging, studying, protecting, strengthening, and reflecting on the clinical trial process." (Horton, 2001)

Link (PDF)

I suggest Wessely and Horton take their own advice.
 
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user9876

Senior Member
Messages
4,556
I had no idea Wessely had actually written a book on clinical trial methodology!

Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research.

Brian Everitt is a statistician so I assume he covered the stats parts. I've found his book on cluster analysis very useful as well as one on multi-variate data analysis that he wrote with Graham Dunn (who was the statistician for FINE).
 

Yogi

Senior Member
Messages
1,132
It has taken me a while to get round to read this. So much going on now.

I agree wholeheartedly wth all the above commenters.

Thank you so much @Jonathan Edwards. This is an amazing article. You cover a lot of good issues and flaws in one article.

I love the last paragraph.

"White et al. conclude that they stand firmly by the findings of the PACE trial, presumably because of their inability to understand its basic flaws. As has been suggested by others, the flaws are so egregious that it would serve well in an undergraduate textbook as an object lesson in how not to design a trial. Its flaws may have only been widely appreciated recently simply because those involved in trial design in other disciplines were unaware of its existence. Now that they are aware, there appears to be near unanimity. The patients have been aware of the problems for several years, and all credit to them for their detailed analyses. In my experience, most of the people with a deep understanding of the scientific questions associated with CFS/ME are patients or carers. To suggest that when these people voice their opinions they are doing a disservice to their peers seems to me inexcusable."

How on earth can anyone make such errors and still not be able to see its flaws. These guys are professors and have got all sorts of awards and now are acting like they do not understand basic concepts. Are they really expecting us to believe that they cannot genuinely understand these issues.

Well this quote sums up the whole sorry sage of PACE:

'It is difficult to get a man to understand something, when his salary depends on his not understanding it.'

To prove this point, the PACE authors have had the most egregious and most unusual financial undisclosed conflicts of interest in medicine with the DWP and insurance companies which they did not disclose to participants. They have saved billions for insurers and governments and sick and disabled patients have lost that same amount, and would continue to do so.

They would have gotten away with it if hadn't been for THE MEDDLING KIDS (like you and all the other patient and scientist critics)


Thank you @Jonathan Edwards for being on PR providing your ongoing advise, Thank you for supporting patients, Thank you for the article!!!
 

user9876

Senior Member
Messages
4,556
I have the book in question. Very low quality work. I searched it previously for any quotes that could be used against PACE and didn't find any.

In itself the absence of quotes suggests the book is poor in that it doesn't cover some of the basics for bias in measurements. I do wonder if he really doesn't understand the arguments but I do find that hard to believe of someone in his position. But then people who are good at politics can do very well in academia (and business) even when they have no clue.