A critical commentary and preliminary re-analysis of the PACE trial

[trishrhymes]

'The therapist should be able to demonstrate a sound knowledge of CFS/ME as participants will generally be well informed about their illness'

So that would be sound knowledge of the BPS model then.

I can't be bothered going through the rest line by line.

What a pile of dangerous and patronising bullshit.

 

[Chrisb]

I was surprised to see that the therapist should display a sound knowledge of the aetiology. I thought that one of the early decisions in the rebranding of ME as CFS was to deny the importance of aetiology. Perhaps the trial designers hoped to learn something from the therapists they recruited.

 

[Daisymay]

In case of interest, here's Professor Hooper's take on the manuals in "Magical Medicine".

http://www.margaretwilliams.me/2010/magical-medicine_hooper_feb2010.pdf

Section 4: Quotations from the PACE Trial Manuals……………………………………………….. 316
Quotations from Therapists’ and Participants’ CBT Manuals………………………………………… 324
Quotations from Therapists’ and Participants’ GET Manuals………………………………………… 345
Quotations from Therapists’ and Participants’ APT Manuals………………………………………… 369
Consideration of SSMC (doctors’) Manual……………………………………………………………… 384

http://www.margaretwilliams.me

 

[chipmunk1]

Positive psychology or hypomanic psychology?

It is certainly not euthymic psychology.

 

[TiredSam]

You can explain the previous positive research findings of GET ...

Perhaps we can pause there for a moment. I wonder if the therapist would be prepared to engage with the patient, empathise, and acknowledge the patient's difficulty in accepting this explanation in the light of the recent analyses of the PACE trial. By not integrating the findings of Matthees, Kindlon, Tuller et. al. into their collaborative model the therapist may be missing a wonderful opportunity to encourage patient optimism.

 

[Jenny TipsforME]

The participant may be very fearful of changing the way they do things, fearing worsening of the symptoms. They may find that their symptoms initially worsen when starting their GET programme.

Yes and getting worse is quite a reasonable thing to fear given that there's no antidote if the 'therapy' is a disaster. "Here's a therapy which may likely make you worse, at least at first and then long term it will make no difference (if you're lucky). In the middle we can be wildly optimistic though and ignore that you're not making any notable improvement. Do you want to sign up?"

 

[Tom Kindlon]

https://twitter.com/i/web/status/818880886154334208

 

[Jenny TipsforME]

@Tom Kindlon it is also likely a major factor in the funding graph looking like this

http://www.meaction.net/wp-content/...-Burden-vs-Funding-e1483825061908-330x330.png

In a fair, objective world all the funding would be on the line.

Although people with HIV are often blamed and they buck the trend. How? Strong community? Years of health pre AIDS to campaign?

 

[A.B.]

Although people with HIV are often blamed and they buck the trend. How? Strong community? Years of health pre AIDS to campaign?

Maybe they had experience in dealing with discrimination, and AIDS was the last straw and a worthy cause to fight for.

 

[Cheshire]

@Tom Kindlon it is also likely a major factor in the funding graph looking like this

http://www.meaction.net/wp-content/...-Burden-vs-Funding-e1483825061908-330x330.png

In a fair, objective world all the funding would be on the line.

Although people with HIV are often blamed and they buck the trend. How? Strong community? Years of health pre AIDS to campaign?

Maybe because AIDS is contagious?

 

[Tom Kindlon]

Maybe because AIDS is contagious?

Also the figures from the US don't show the full extent of the suffering worldwide from HIV/AIDS which is much more prevalent in some other countries.

 

[Barry53]

Maybe because AIDS is contagious?

I think that would be a strong motivation. Plus just a bit harder for the pseudo-psychiatrists to lay claim to as "theirs".

 

[Snow Leopard]

Also the figures from the US don't show the full extent of the suffering worldwide from HIV/AIDS which is much more prevalent in some other countries.

HIV/AIDS is still relatively overfunded when considering worldwide and future projected burden.

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0016837

Arguably some of that money could have been better spent on prevention in developing countries, but I digress...

 

[user9876]

I assume this graph is somewhat dynamic in that the disease burden is partly a function of available treatments (which would reduce the burden) and this is a function of research spending (or research success).

I'm not completely bought into the idea that research funding should be just determined by the disease burden. I'm thinking it should also be related to things like the maturity of the science. In a well explored area there may be little point in doing much research unless there is a break through in the fundamental underlying science that can lead to new approaches.

So I would argue that as well as the overall disease burden meaning ME research should have more funding it is also because big gains could be gained. I.e. the current research is very immature and as such putting money into this area is likely to have a good chance of a significant effect in reducing the disease burden for ME.

 

[Snow Leopard]

I'm not completely bought into the idea that research funding should be just determined by the disease burden. I'm thinking it should also be related to things like the maturity of the science. In a well explored area there may be little point in doing much research unless there is a break through in the fundamental underlying science that can lead to new approaches.

So I would argue that as well as the overall disease burden meaning ME research should have more funding it is also because big gains could be gained. I.e. the current research is very immature and as such putting money into this area is likely to have a good chance of a significant effect in reducing the disease burden for ME.

None of the areas are really "mature".

But you do make an important point, specifically the need to build research capacity in neglected areas.

 

[Barry53]

I do not have a strong background in statistics, so am unable to follow all the reanalysis. So I decided to run my own much simplified analysis on the source data spreadsheet. What is confusing me is I am getting lower participant recovery numbers for original endpoint than the reanalysis did. e.g. 6 for CBT rather than 11, 5 for GET rather than 7, 1 for APT rather than 3, and 2 for SMC rather than 5. I do not think (but I am by no means sure) this is simply due to my non-statistical approach, but would like to know one way or the other.

I have only counted participants who fulfilled all four criteria. Because the original protocol endpoint ME/CFS criterion is not available, I used the simple Oxford criterion that is available, meaning my numbers would still give recovery rates on the optimistic side.

If anyone can help clarify why I am seeing different numbers I would appreciate it. Happy to make my spreadsheet available if need be.

I have some basic understanding of statistics, and would be grateful to better understand the stats techniques used in the reanalysis. Any pointers would be much appreciated.

 

[Barry53]

Bug in my spreadsheet. Thanks @Tom Kindlon, who pointed out I was using the wrong 52 week CGI score.

 

[AndyPR]

The ME Association believe that a recent independent re-analysis of the PACE Trial data is such an important document that we have paid the publisher, Taylor & Francis, to open the full paper for all to read.

At the moment, the full text is hidden behind a paywall and all that people can read without paying a hefty subscription is a 213-word abstract.

http://www.meassociation.org.uk/2017/02/29928/

 

[Barry53]

Excellent!

When the unpublished PACE trial data was re-analysed by Wilshire et al (2017)

Minor point: Was it 2017, or late 2016?

 

[AndyPR]

Excellent!

Minor point: Was it 2017, or late 2016?

Should be 2016.