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The Mental Elf: Simon Wessely on PACE

Jonathan Edwards

Jonathan Edwards

"Gibberish"
Messages
5,256
charles shepherd said:
This has been posted elsewhere by someone with a very good sense of humour:

NEW CANARD PASSENGER LINE

Southampton to New York in 5 days

Canard has announced the successful first voyage of its flagship, the Queen Mary Pace. Built in Oxford to rigorous specifications, this sleek and sophisticated liner, with the latest engines built with Graduated Energy Transmission, has taken the world by storm with the first crossing in just 5 days.
Click to expand...

Very neatly done. Funny that the word canard had come to my mind earlier in the week, but I did not realise why.
 
Jonathan Edwards

Jonathan Edwards

"Gibberish"
Messages
5,256
Daisymay said:
Contrary to what Wessely said in his mental elf blog, PACE wasn't a randomised controlled trial.

He said: "Reading some of the criticism, I am struck that some of the critics are not familiar with the fundamental strengths of the randomised control trial, and why medicine continues to value it so highly. "

And : "What makes a good trial and how does PACE measure up?
So what does the literature on randomised controlled trials tell us about the factors that are known to influence or bias the results of trials?"

He is giving the impression to readers it was a gold standard RCT, but it wasn't, SMC group wasn't a control group and the paper didn't call itself a RCT, see here:

The title of the PACE trial:
"Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial"

And in the paper:
"Methods - In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome"

Though the protocol paper called it a RCT in the title:
" Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol 7:6. doi: http://dx.doi.org/10.1186/1471-2377-7-6"

And in the protocol paper in "Type of Design" they also said it was a RCT - it wasn't a RCT.
"Type of design - A four arm, randomised multi-centre parallel group controlled trial of patients who meet operationalised criteria for CFS/ME, with follow-up for 52 weeks (see Figure 1)."

Can someone who is on twitter point this out to Coyne please?
Click to expand...

This is an interesting point. Again it shows the inability of those supporting PACE to understand why it is no good.

There may be no laid in stone definition of controlled (not control, as SW seems to say) trial, but I think it is fair to base it on what we mean by a controlled experiment in a broad sense. A controlled experiment is one in which an intervention or scenario suspected of having a specific causal explanation is compared with another intervention or scenario that can be expected to match the first in terms of all other contextual causal factors, apart from the one being used as the specific explanation. (Apologies for the contorted sentence.) The difference in outcome can then be reasonably attributed to the explanation being tested and to that alone.

It is clear that PACE was not a controlled experiment in this sense. It might be argued that controlled experiments can never be perfect and that at least there was as good a control as practical - giving some idea of 'what would have happened without the specific intervention'. However, in this case this is no good. As people have pointed out the treatments touted as the best - CBT and GET - will have had placebo effects, whereas having no treatment, which is what SMC effectively was, will have had a nocebo effect. This is in no way a placebo controlled trial. In fact, as Knoop has suggested, the placebo is the preferred treatment: CBT. So the comparator is completely different from the tested treatment and therefore not a 'control'.

The only argument against this I can think of is that if we are thinking of CBT as a placebo then this trial rather nicely shows that when you compare a placebo with a nocebo you get quite a nice placebo effect. But then the whole reason why controlled trials are gold standards is to eliminate placebo effects.

You are right, this is not a controlled trial in any sense that is a gold standard. To say so is either very foolish or a deliberate misrepresentation.
 
jimells

jimells

Senior Member
Messages
2,009
Location
northern Maine
The Mental Elf has published my comment:

Sir Simon:

I very much enjoyed your comparison of PACE with the Titantic. We all know how that voyage ended, and PACE is headed for the same fate. In fact, it has already struck a giant iceberg in the form of David Tuller’s analysis.

Perhaps you haven’t realized yet that the U.S. National Institutes of Health threw you overboard last week when it announced an intramural research program of actual biomedical research, along with a promise of a substantial increase in the extramural funding.

I just have one question for you:

How long can you tread water??

-------------
I must say i find Sir Simon's latest rant to be quite entertaining. Of course, I didn't bother to read most of it. I understand why Dr Coyne is so pissed at Mental Elf (my eyes see "Mental Elf" but my brain keeps reading "Mental Midget"), but perhaps they have done us a favor by publishing such a ridiculous essay.
 
Jonathan Edwards

Jonathan Edwards

"Gibberish"
Messages
5,256
I have finally read the blog through. The problem is that however many icebergs you point out that you missed, if you hit a big one it makes no difference. The blog carefully avoids the one central issue - that nobody in clinical pharmacology would take this trial seriously if the treatment was a drug because of what we know about what happens with lack of blinding and subjective endpoints. Trials like this of physiotherapy in rheumatology are no longer taken any notice of because we have moved on to proper science and effective treatments.
 
SOC

SOC

Senior Member
Messages
7,849
Graham said:
Actually "canard" has a dual meaning: duck is one, as in quackery, and "unfounded rumour" is the other. You were right the first time though, it is one of my weird pieces.
Click to expand...
Nothing weird about it. It is a superb piece that makes a very clear point on a dreadful subject in an entertaining way. It doesn't get much better than that. :thumbsup: I, for one, would love to see more.
 
G

Gijs

Senior Member
Messages
691
Taken together, there is clearly work towards a desired outcome. This has nothing to do with objective science. There is juggled with data and standards. These researchers should be ashamed. This smells like fraud and nepotism (peer reviewed?).
 
A.B.

A.B.

Senior Member
Messages
3,780
Jonathan Edwards said:
I have finally read the blog through. The problem is that however many icebergs you point out that you missed, if you hit a big one it makes no difference. The blog carefully avoids the one central issue - that nobody in clinical pharmacology would take this trial seriously if the treatment was a drug because of what we know about what happens with lack of blinding and subjective endpoints. Trials like this of physiotherapy in rheumatology are no longer taken any notice of because we have moved on to proper science and effective treatments.
Click to expand...

Coyne is working on a response to the Lancet together with Keith Laws. Maybe that's an opportunity for you to state the obvious?
 
RustyJ

RustyJ

Contaminated Cell Line 'RustyJ'
Messages
1,200
Location
Mackay, Aust
It sound like a reverse of the old excuse 'I was ordered to do it'. In this case SW may have done the ordering, but since he did not pull the trigger, he is absolved.
 
RustyJ

RustyJ

Contaminated Cell Line 'RustyJ'
Messages
1,200
Location
Mackay, Aust
It wasn't the only time SW denied being part of the PACE trial:

At 16 mins, speaking about the PACE trial, Simon Wessely says: "It was the "final, kind of, definitive trial... I'm not connected with this trial. I recruited some patients for it but I was not part of it... I wish I had been...because it's a genuinely beautiful trial. It's one of the most beautiful behavioural medicine trials that we've ever seen... So, it's a fantastic and beautiful trial... We've improved the physical health, the psychological health, functioning and so on of a large number of people... It's also incredibly safe despite some of the things that's been said about it... these are very, very, safe treatments." Taken from: http://www.foundation.org.uk/Events/AudioPdf.aspx?s=1200...

I don't have a date for this yet. Perhaps someone does?

Google is my friend: May 4, 2011. How bizarre. The wording (although split up in the poison elf blog) is uncannily similar.
 
Simon

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
Thanks, @RustyJ, for digging that out.
RustyJ said:
At 16 mins, speaking about the PACE trial, Simon Wessely says: "It was the "final, kind of, definitive trial... I'm not connected with this trial. I recruited some patients for it but I was not part of it... I wish I had been...because it's a genuinely beautiful trial. It's one of the most beautiful behavioural medicine trials that we've ever seen... So, it's a fantastic and beautiful trial...
Click to expand...
As a patient, I'm not interested or impressed by whether or not it's a good behavioural medicince trial, just if it's a good medicine trial. If behavioural trials happily accept using self-reports in unblinded trials with no attempt at placebo (such as relaxtion therapy) - and make no attempt to address those weaknesses when interpreting the trial - then it's not focusing on the interest of patients, and that's not good enough.

I'd also like to think the authors would admit things didn't work out when even the self-report measures in an unblinded trial without proper controls shows no difference at long-term follow-up. But that didn't happen. I've no idea, maybe that's the norm in behavioural medicine (I hope not) but it won't do for my illness. And I will publicly disagree when it happens. That is a disagreement over methodology from someone at the sharp end of the illness - to whom real progress and real recovery actually matter - not harassment of researchers.

Simon Wessley said:
...We've improved the physical health, the psychological health, functioning and so on of a large number of people...
Click to expand...
No change in fitness or walking capacity (OK a tiny gain in walking after a year of exercise) or employment status or disability claims status. (I'd thought they'd collected at least employment data for long-term follow-up - perhaps that will come later...?). Can we ground claims in the real world, please?

The US congress has devoted huge funding to PCORI, a body that focuses on research measuring outcomes that matter to patients (which by definition are genuine changes, not simply changes in questionnaire scores). The MRC and it's sister body the NIHR play at least lip-service to the idea that all researchers should involve patients in the design of studies, so that studies focus on what matters to patients. The PACE trial makes is a good illustration of the need for more active patient involvement.

More information in my blog Time for a Patient Revolution (note the title is based on a BMJ editorial).
 
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Esther12

Esther12

Senior Member
Messages
13,774
Thinking about how the awesome splendour of aspects of the PACE trial (I'm sure a lot of researchers are jealous of the funding it received) can distract from the serious problems with it, I was reminded of some famous cinema bluster:

If patients have obtained a complete
technical readout of this trial,
it is possible, however unlikely,
that they might find a weakness and
exploit it.

...

We've analyzed their arguments, sir,
and there is a danger. Should I have
your excuses standing by?


Excuses? In our moment of triumph?
I think you overestimate their
chances!

...

Bang.

 
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