PACE Trial and PACE Trial Protocol

[Enid]

Do they mention exactly what standard medical care was - be interesting to know what treatments were used - might educate my Docs too. But we know there is no such thing as standard ME medical care in the UK yet (nor full investigations in the first place).

 

[Bob]

I agree there's a good chance they were deluded. However, I don't think the percentage figures you are comparing are the correct ones. When they said GET and CBT, they mean GET+SMC and CBT+SMC - the figures for these weren't 12% and 13.5%. (Alternatively take 10% away from their predictions).

I'm not sure Dolphin...
The passage that I took the quote from, in the protocol, doesn't indicate that that's what they meant:

11. Sample Size
11.1 Assumptions
At one year we assume that 60% will improve with CBT, 50% with GET, 25% with APT and 10% with SSMC. The existing evidence suggests that at one year follow up, 50 to 63% of participants with CFS/ME had a positive outcome, by intention to treat, in the three RCTs of rehabilitative CBT, [18, 25, 26] with 69% improved after an educational rehabilitation that closely resembled CBT.E 433 This compares to 18 to 63% improved in the two RCTs of GET, [23' 241 and 47% improvement in a clinical audit of GET.E 54] Having usual medical care allowed 6% to 17% to improve by one year in two RCTs.E 18' 253 There are no previous RCTs of APT to guide us,[11' 12] but we estimate that APT will be at least as effective as the control treatments of relaxation and flexibility used in previous RCTs, with 26% to 27% improved on primary outcomes.E23' 26] We propose that a clinically important difference would be between 2 and 3 times the improvement rate of SSMC.

 

[Bob]

I wouldn't let Peter White off the hook that easy. There was also this. I think he was the driving force between these newsletters and could be said to be responsible for the contents (with TC & MS):

http://www.pacetrial.org/docs/participantsnewsletter4.pdf

Thanks Dolphin. You're right, I shouldn't let him off that easy.
And I was totally wrong: I've now remembered that there are examples of White misrepresenting the results.

For a start, the whole paper is an exercise of manipulation and obfuscation anyway.
And I don't know how the media ended up reporting a 30% recovery rate, but I haven't seen White object to that yet.

There was also the Centre for Psychiatry Newsletter, by Peter White. Issue 2. Spring 2011, which was a lesson in obfuscation:

FINDING THE RIGHT PACE FOR TREATING CHRONIC FATIGUE SYNDROME, by Peter White

"By a year, some six out of ten patients made a clinically useful improvement in both fatigue and function after both CBT and GET compared to about four out of ten for APT and 45% for SMC alone."
(Not so - only 13% made a clinically useful improvement after CBT and GET.)

"CBT and GET were more effective in improving both fatigue and physical function that either SMC alone of APT."
(Not so - SMC alone was more effective than CBT and GET.)

 

[Esther12]

I agree there's a good chance they were deluded. However, I don't think the percentage figures you are comparing are the correct ones. When they said GET and CBT, they mean GET+SMC and CBT+SMC - the figures for these weren't 12% and 13.5%. (Alternatively take 10% away from their predictions).

I agree. And also, there are so many solid, clear points to make against the way in which the results from PACE were presented, that something like this, which seems rather tenuous and dependent upon interpretation, would only serve as a distraction imo.

As they only expected 10% to improve in the SSMC group, they possibly didn't give much thought to the importance of accounting for the positive affect it would have in the CBT and GET groups.

Bob: Was that quote from the protocol or the trial identifier (or something?). I just checked and couldn't see it in the protocol. It is funny how differently the talk about SSMC, and how they now seem to present the benefits from a treatment they'd previously expected to be much less effective that flexibility control groups, as evidence that money should be spent on their CFS specialist services.

I wouldn't let Peter White off the hook that easy. There was also this. I think he was the driving force between these newsletters and could be said to be responsible for the contents (with TC & MS):

http://www.pacetrial.org/docs/participantsnewsletter4.pdf

The repeated and misleading use of the term 'back to normal' doesn't just seem coincidental doe it?

 

[Bob]

Do they mention exactly what standard medical care was - be interesting to know what treatments were used - might educate my Docs too. But we know there is no such thing as standard ME medical care in the UK yet (nor full investigations in the first place).

Yes, they do outline what was involved in SMC. It's just very basic normal 'medical care', that you'd expect to see from a UK GP, such as being given pain and sleep meds, when appropriate. (I think it might also have involved educating people to avoid extremes of activity - But I'm not certain about that - I'd need to check that out.)

But be aware, Enid, that the SMC group was a control group, so any fluctuations or improvements, seen over the year, may have been natural changes.

I think Graham has outlined SMC somewhere. I'll have a look for it and post a link in this thread.

 

[Bob]

Bob: Was that quote from the protocol or the trial identifier (or something?). I just checked and couldn't see it in the protocol.

Yes, it's from the long protocol.

It is funny how differently the talk about SSMC, and how they now seem to present the benefits from a treatment they'd previously expected to be much less effective that flexibility control groups, as evidence that money should be spent on their CFS specialist services.

Yes, should money be spent on a CFS service if only 1 in 8 patients respond, and there is a chance that many deteriorate? No wonder they keep saying that 60% improved from CBT and GET, or whatever figure they happen to pluck out of the air.

The repeated and misleading use of the term 'back to normal' doesn't just seem coincidental does it?

It doesn't seem coincidental, does it. Nor does the fact that so many newspapers reported a 30% recovery rate.

 

[Enid]

Bob I'm still not happy with the notion of standard medical care - the usual - heart, lungs, basic blood tests for infections, any specifics eg hypothyroidism etc. The notion of medical care lends some legitimacy to the other psyche mumbo jumbo however they use it. How clever to bring it in and 10% to improve only - well they might be right if the Docs (and we know it) do not understand the illness in the first place. Sort of hey we are in with Docs (not the four in my family who know they don't know but watch all developing medical research in order to try to treat effectively, what to look for/special tests the most important).

 

[Dolphin]

I'm not sure Dolphin...
The passage that I took the quote from, in the protocol, doesn't indicate that that's what they meant:

I just checked. Before this in the protocol they said:
http://www.biomedcentral.com/1471-2377/7/6/

NB For the sake of brevity, the rest of the protocol will refer to the four treatment arms as APT, CBT, GET and SSMC rather than APT plus SSMC, CBT plus SSMC, GET plus SSMC and SSMC alone.

 

[Bob]

I just checked. Before this in the protocol they said:
http://www.biomedcentral.com/1471-2377/7/6/

NB For the sake of brevity, the rest of the protocol will refer to the four treatment arms as APT, CBT, GET and SSMC rather than APT plus SSMC, CBT plus SSMC, GET plus SSMC and SSMC alone.

Thanks for finding that Dolphin. Sorry to put you to that work.

Like you say, we just have to subtract 10% from their predictions for the CBT group and GET group.

 

[Dolphin]

Thanks for finding that Dolphin. Sorry to put you to that work.

No worries, wasn't much work.

Like you say, we just have to subtract 10% from their predictions for the CBT group and GET group.

Well, just to say that I'm not a major fan of that either, as it can be disputed (although it's more a technicality in this case I think). Often in papers generally, interaction effects will be looked for X x Y. Sometimes two "conditions"* can lead to a better result i.e. X + Y together could be better than the results of X and Y separately (or alternatively, it could be worse).

Although a lot of the time in practice, other studies, etc, GET = GET + SMC, etc so it's not necessarily a good example of interaction effects; however, it could be made.

* does not mean two medical conditions, just that two things have happened, or an individual has both characteristics.

 

[Bob]

Well, just to say that I'm not a major fan of that either, as it can be disputed (although it's more a technicality in this case I think). Often in papers generally, interaction effects will be looked for X x Y. Sometimes two "conditions"* can lead to a better result i.e. X + Y together could be better than the results of X and Y separately (or alternatively, it could be worse).

Although a lot of the time in practice, other studies, etc, GET = GET + SMC, etc so it's not necessarily a good example of interaction effects; however, it could be made.

* does not mean two medical conditions, just that two things have happened, or an individual has both characteristics.

Yes, I see what you mean.

It would be more acceptable if the authors rigorously used proper and accurate wording and always said something like: "When CBT was added to SMC, 12% more patients improved over SMC alone". But they rarely use such clear wording!

And SMC was used as a control group, it was designed for us to look at the effects of CBT and GET, in isolation, using the 'mean difference from SMC'.

It was just a badly designed study. They should have included an SMC+relaxation group. Then we could have compared the additional effects of CBT/GET with the additional effects of relaxation. That would have been so much more helpful, and transparent. I'm surprised that they were allowed to progress with such a study, without a proper control group. (Except, nothing about the PACE Trial, or the Lancet, or the MRC, surprises me any more!)

 

[Bob]

Further work by Malcolm Hooper.

Magical Medicine - the PACE Trial
UPDATE ON THE PACE TRIAL

Professor Malcolm Hooper

11th July 2012​

​

http://www.investinme.org/Article 432 - PACE Trial Update July 2012.htm

(I haven't read it yet)

 

[user9876]

Further work by Malcolm Hooper.

Magical Medicine - the PACE Trial
UPDATE ON THE PACE TRIAL

Professor Malcolm Hooper

11th July 2012​

​

http://www.investinme.org/Article 432 - PACE Trial Update July 2012.htm

(I haven't read it yet)

Prof Hoopers writing always worried me. It does tend to come across as a rant. He also says too much wanting to put all points in everywhere. Seems to me that he needs a good PR person who can think about what message to give where. Good politics and communications often involves choosing a message for the audiance, one that they can understand, will resonate with them and that is within their attention span. Simon Wessely is a good communicator which is why they get away with so much.

We need to think about the art of story telling to get our story across until that happens I fear that Wessely and friends will continue to be able to dismiss all decent.

 

[biophile]

Ask yourselves which one of these accusations sounds more conspiracy theorist -esque:

1) PACE engaged in a face saving exercise because of the sheer investment they have in CBT/GET;

2) we conspired in an 'organized hate campaign' to bring down PACE because the results were unpleasant.

 

[Bob]

Ask yourselves which one of these accusations sounds more conspiracy theorist -esque:

1) PACE engaged in a face saving exercise because of the sheer investment they have in CBT/GET;

2) we conspired in an 'organized hate campaign' to bring down PACE because the results were unpleasant.

I think I might know the answer... Do we get a prize for the right answer?

 

[alex3619]

Prof Hoopers writing always worried me. It does tend to come across as a rant. He also says too much wanting to put all points in everywhere. Seems to me that he needs a good PR person who can think about what message to give where. Good politics and communications often involves choosing a message for the audiance, one that they can understand, will resonate with them and that is within their attention span. Simon Wessely is a good communicator which is why they get away with so much.

We need to think about the art of story telling to get our story across until that happens I fear that Wessely and friends will continue to be able to dismiss all decent.

I mostly do not see Hooper coming across as a rant. He is itemizing events and findings, creating a public record of what has gone on and is continuing to happen.

However a problem that occurs time and again is that Hooper makes apparent claims about motivations and reasons for things happening that, while they might be fine as questions, are hard to establish as facts. In doing this pieces of his arguments could be construed as conspiracy theories.

A case in point:
"What is at stake here is the fact that the PACE Trial is scientifically flawed and the results have been misrepresented so NICE, insurance companies, the DWP and private companies contracted by the government (including Atos) are relying on false interpretation of the data to the serious detriment of very sick people."
http://www.investinme.org/Article 432 - PACE Trial Update July 2012.htm

This is technically accurate I think, but it might be interpreted as the reason for the misinformation is to support NICE, insurance etc. This sounds like a conspiracy theory. Whereas, in my interpretation, Hooper is only talking about consequences. Which interpretation people will draw may be biased by their view of the entire issue. Those ranting about crazy patient hate campaigns might see it as a bogus conspiracy smear. Those who are aware of the history and conflicts of interest might be drawn into seeing a conspiracy claim also. In my view the best interpretation is with a more neutral tone. The misleading information will have a consequence of biasing the response of the groups mentioned. This is a direct logical conclusion if you agree with the premise (as I do) that the presentation of the results is misleading. I wonder how many will interpret it the same as me though?

Bye, Alex

 

[user9876]

However a problem that occurs time and again is that Hooper makes apparent claims about motivations and reasons for things happening that, while they might be fine as questions, are hard to establish as facts. In doing this pieces of his arguments could be construed as conspiracy theories.

I think it is this aspect, along with the need to list everything all the time that makes it sound like a rant to me.

I think it is important that we think of how a message is delivered. We need to think who are we trying to tell a message to and what is the best way to tell the story so that we can influance how they think.

If there is going to be a debate on the pace trial or ME in general in the house of lords then we need to think about having an information campaign aimed at the members. Its hard to get long briefing documents read so one or two pages of summary message is good perhaps backed up by a longer document. There is an art to writing simple to the point but interesting text that will catch peoples attention. Having tried to write a document explaining a technical subject to a wider audiance with the help of a marketing department I know I don't have the skills.

The voices in the shaddows film seems to have been effective at communicating the message.

 

[Esther12]

I've not read a lot of Hoopers stuff, or the new thing, but generally, I've not been a fan of what I've seen. It seems to mix up good points and weak/inaccurate points in a way which ends up being self-undermining.

Ask yourselves which one of these accusations sounds more conspiracy theorist -esque:

1) PACE engaged in a face saving exercise because of the sheer investment they have in CBT/GET;

2) we conspired in an 'organized hate campaign' to bring down PACE because the results were unpleasant.

Claims can only be dismissed as a crazy conspiracy theory if they're critical of people in positions of power... it's a conspiracy!

 

[Snow Leopard]

Claims can only be dismissed as a crazy conspiracy theory if they're critical of people in positions of power... it's a conspiracy!

Interesting point...

 

[Firestormm]

Prof Hoopers writing always worried me. It does tend to come across as a rant. He also says too much wanting to put all points in everywhere. Seems to me that he needs a good PR person who can think about what message to give where. Good politics and communications often involves choosing a message for the audiance, one that they can understand, will resonate with them and that is within their attention span. Simon Wessely is a good communicator which is why they get away with so much.

We need to think about the art of story telling to get our story across until that happens I fear that Wessely and friends will continue to be able to dismiss all decent.

I have to say I share your concerns (I did read this 'update' from Hooper yesterday). I was hoping that this time round rather than invoking sentiment and opinion it would focus on what was factually wrong with what was presented (in terms of the PACE paper), the process and how it was covered in the media.

Be interested to know what Dolphin thinks of this latest - dare I say - 'rant'. As you say, if there is to be a debate in the House then it needs to be focused (not that I think there will be an open debate about the PACE Trial).

Too much 'Wessely-baiting'. Focus on the 'waste' of taxpayers money and how even after £5million expenditure and all the banner-waving - implementation and availability of these so-called treatments to the multitude of patients has not happened.

And despite PACE the MRC have felt the need to pump even more (though not half as much) money into ME to try and find more effective treatments.

Those in Government want to get us back to work. 'We' want to get back to work. The PACE Trial and it's 'treatments' promised this - and it FAILED miserably. FACT.

Even 30% of us back at work would be something to make a headline out of....

And... I remain to be convinced that the protocols for CBT/GET used in the PACE Trial are the same protocols used in the real world. Certainly ain't in my albeit limited experience. And that's not such a bad thing either. Still, if what was prescribed in PACE as being successful has not been rolled out to the nation intacto then £5million has been wasted for sure.

Humph. Back to bed (having accepted my condition for what it is and not being a perfectionist )