PACE Trial and PACE Trial Protocol

[Tom Kindlon]

https://twitter.com/i/web/status/779842967070801920

 

[Seven7]

Somebody mentioned that they used oxford criteria then lowered the 6 months to one month (so was not even oxford criteria, has this been verified?

 

[Dolphin]

Somebody mentioned that they used oxford criteria then lowered the 6 months to one month (so was not even oxford criteria, has this been verified?

This document is very useful for answering questions about what they did:

http://evaluatingpace.phoenixrising.me/PACE_Protocol.pdf
I see the Chalder fatigue scale asks about the last month and the questions about the CDC symptoms are about last week. So both are not over the last 6 months as they should be.

 

[Dolphin]

https://twitter.com/i/web/status/781133088839565312

 

[Tom Kindlon]

https://twitter.com/i/web/status/782222598734217216

https://twitter.com/i/web/status/782223503781203968

 

[Tom Kindlon]

https://twitter.com/i/web/status/782164012171661312

 

[RogerBlack]

I note there is mention of White et al only sharing data with an agreed analysis plan.
Has anyone attempted to get a copy of this from the Cochraine collaboration, for example?
It could be informative as to what the 'inputs' they were seeing from the data they got cooperatively were, or if they were free to do a proper analysis, but failed to.

 

[Esther12]

There's the cochrane IPD protocol published - it looks completely rubbish, and includes people who spun the last Cochrane exercise review. Seaturtle submitted some comments on this here: http://forums.phoenixrising.me/inde...ane-review-of-exercise-therapy-for-cfs.45282/

 

[Dolphin]

https://twitter.com/i/web/status/788431951006986240

 

[Barry53]

That is very interesting! I didn't think the response I got from our MP was terribly personal. I get just a hint they may all be working to a common script . I suppose it was over-optimistic to hope an MP would get off the fence. Once they know which way the wind is going to blow, then they might. Here's what I got:-

Dear Mr ...,

Thank you for contacting me about clinical trials and Graded Exercise Therapy (GET).

I am aware that the National Institute for Health and Care Excellence (NICE) recommends GET for CFS/ME patients where it is deemed appropriate. However, patients have the right to be involved in decisions about their treatment. There is no one form of treatment to suit every patient and patients should not be forced into treatments they do not want. Rather there must be a collaborative relationship between clinician and patient so that treatment and care take into account personal needs and preferences. This means that patients will always be able to have the last word on their treatments whilst receiving the advice that they need.

The PACE trial you refer to was the largest ever trial of treatments for the condition and provided evidence that GET is moderately effective when provided alongside specialist medical care. The treatment was found to be safe and in 2013, a follow-up study was published that supported the findings that GET is the most likely to lead to recovery.

NICE considered the PACE trial results when it reviewed the guidelines in 2011 and concluded that the results supported its decision to maintain the existing guidelines. NICE last reviewed the guidance with its stakeholders, including CFS/ME charities, in 2013. The review found no update was required. The full guidelines may be viewed on the NICE website at the following link: www.nice.org.uk/guidance/cg53

I understand that there have been a number of requests for the public release of data from the PACE trial which have been declined. It is my understanding that anonymised data has been made available to independent scientists, as part of normal research collaboration. The release of further data is not deemed responsible as it could breach data protection laws. Nevertheless, further ethical and scientific advice is being sought on how best to provide access to relevant data in a way that balances the rights of participants with the public interest in releasing trial data. Ultimately, the Government seeks to act in accordance with the law, whilst considering freedom of choice and what is best for the citizens affected by these trials.

I hope this email provides a sense of assurance and thank you again for taking your time to get in touch with me.

Regards,
....

 

[BurnA]

These letters are clearly just standard blurb.
That's not surprising not should it be a deterrent. It's up to us to educate our elected representatives about what is going on.
The question is how is that best done ?

 

[Barry53]

These letters are clearly just standard blurb.
That's not surprising not should it be a deterrent. It's up to us to educate our elected representatives about what is going on.
The question is how is that best done ?

I think the problem is one of 'arris-covering rather than one of education. Part of a politicians DNA I fear.

But I do not disagree: we still need to try.

 

[Tom Kindlon]

That is very interesting! I didn't think the response I got from our MP was terribly personal. I get just a hint they may all be working to a common script . I suppose it was over-optimistic to hope an MP would get off the fence. Once they know which way the wind is going to blow, then they might. Here's what I got:-

Dear Mr ...,

Thank you for contacting me about clinical trials and Graded Exercise Therapy (GET).

I am aware that the National Institute for Health and Care Excellence (NICE) recommends GET for CFS/ME patients where it is deemed appropriate. However, patients have the right to be involved in decisions about their treatment. There is no one form of treatment to suit every patient and patients should not be forced into treatments they do not want. Rather there must be a collaborative relationship between clinician and patient so that treatment and care take into account personal needs and preferences. This means that patients will always be able to have the last word on their treatments whilst receiving the advice that they need.

The PACE trial you refer to was the largest ever trial of treatments for the condition and provided evidence that GET is moderately effective when provided alongside specialist medical care. The treatment was found to be safe and in 2013, a follow-up study was published that supported the findings that GET is the most likely to lead to recovery.

NICE considered the PACE trial results when it reviewed the guidelines in 2011 and concluded that the results supported its decision to maintain the existing guidelines. NICE last reviewed the guidance with its stakeholders, including CFS/ME charities, in 2013. The review found no update was required. The full guidelines may be viewed on the NICE website at the following link: www.nice.org.uk/guidance/cg53

I understand that there have been a number of requests for the public release of data from the PACE trial which have been declined. It is my understanding that anonymised data has been made available to independent scientists, as part of normal research collaboration. The release of further data is not deemed responsible as it could breach data protection laws. Nevertheless, further ethical and scientific advice is being sought on how best to provide access to relevant data in a way that balances the rights of participants with the public interest in releasing trial data. Ultimately, the Government seeks to act in accordance with the law, whilst considering freedom of choice and what is best for the citizens affected by these trials.

I hope this email provides a sense of assurance and thank you again for taking your time to get in touch with me.

Regards,
....

I find these MPs' replies odd. Maybe it happens in the UK in other situations but generally I get the impression in Ireland Irish MPs would pass on any responses they got from ministers but wouldn't get involved like this themselves, spouting what are clearly other people's words (they're hardly likely to be experts on ME/CFS) unless the issue related to some party policy.

 

[Barry53]

I find these MPs' replies odd. Maybe it happens in the UK in other situations but generally I get the impression in Ireland Irish MPs would pass on any responses they got from ministers but wouldn't get involved like this themselves, spouting what are clearly other people's words (they're hardly likely to be experts on ME/CFS) unless the issue related to some party policy.

My jaded belief is it is politicians smoke and mirrors, trying to give the impression they are on board and onside, whilst covering their behinds at the same time. The thing they never seem to realise, is what embarrassingly incompetent illusionists they actually are.

 

[Esther12]

That is very interesting! I didn't think the response I got from our MP was terribly personal. I get just a hint they may all be working to a common script . I suppose it was over-optimistic to hope an MP would get off the fence. Once they know which way the wind is going to blow, then they might. Here's what I got:-

Dear Mr ...,

Thank you for contacting me about clinical trials and Graded Exercise Therapy (GET).

I am aware that the National Institute for Health and Care Excellence (NICE) recommends GET for CFS/ME patients where it is deemed appropriate. However, patients have the right to be involved in decisions about their treatment. There is no one form of treatment to suit every patient and patients should not be forced into treatments they do not want. Rather there must be a collaborative relationship between clinician and patient so that treatment and care take into account personal needs and preferences. This means that patients will always be able to have the last word on their treatments whilst receiving the advice that they need.

The PACE trial you refer to was the largest ever trial of treatments for the condition and provided evidence that GET is moderately effective when provided alongside specialist medical care. The treatment was found to be safe and in 2013, a follow-up study was published that supported the findings that GET is the most likely to lead to recovery.

NICE considered the PACE trial results when it reviewed the guidelines in 2011 and concluded that the results supported its decision to maintain the existing guidelines. NICE last reviewed the guidance with its stakeholders, including CFS/ME charities, in 2013. The review found no update was required. The full guidelines may be viewed on the NICE website at the following link: www.nice.org.uk/guidance/cg53

I understand that there have been a number of requests for the public release of data from the PACE trial which have been declined. It is my understanding that anonymised data has been made available to independent scientists, as part of normal research collaboration. The release of further data is not deemed responsible as it could breach data protection laws. Nevertheless, further ethical and scientific advice is being sought on how best to provide access to relevant data in a way that balances the rights of participants with the public interest in releasing trial data. Ultimately, the Government seeks to act in accordance with the law, whilst considering freedom of choice and what is best for the citizens affected by these trials.

I hope this email provides a sense of assurance and thank you again for taking your time to get in touch with me.

Regards,
....

IMO: It would be good to continue this correspondence if you can.

Ask if they now understand the problems with these claims, and particularly the PACE trial's reported recovery rates:

The PACE trial you refer to was the largest ever trial of treatments for the condition and provided evidence that GET is moderately effective when provided alongside specialist medical care. The treatment was found to be safe and in 2013, a follow-up study was published that supported the findings that GET is the most likely to lead to recovery.

Ask what it was that led to this understanding:

I understand that there have been a number of requests for the public release of data from the PACE trial which have been declined. It is my understanding that anonymised data has been made available to independent scientists, as part of normal research collaboration. The release of further data is not deemed responsible as it could breach data protection laws. Nevertheless, further ethical and scientific advice is being sought on how best to provide access to relevant data in a way that balances the rights of participants with the public interest in releasing trial data. Ultimately, the Government seeks to act in accordance with the law, whilst considering freedom of choice and what is best for the citizens affected by these trials.

There's clearly some civil servant somewhere churning out BS, and it would be good to push them a bit on the details.

 

[Jan]

They do not appear to know the PACE trial data was released?

 

[Barry53]

They do not appear to know the PACE trial data was released?

I returned a short and slightly sweet reply, and pointed exactly this out to them .

 

[Barry53]

IMO: It would be good to continue this correspondence if you can.

In process.

 

[Barry53]

I know the reanalysis of the release PACE trial data by Alem Matthees et al was titled as being "preliminary". Do we know if there is any further work being done investigating that data, or was that reanalysis deemed all that is needed? Or is it possible that other investigators might glean fresh insights with further analysis?

 

[Esther12]

I know the reanalysis of the release PACE trial data by Alem Matthees et al was titled as being "preliminary". Do we know if there is any further work being done investigating that data, or was that reanalysis deemed all that is needed? Or is it possible that other investigators might glean fresh insights with further analysis?

I thikn one of the statisticians said that they're preparing a paper for publication in a medical journal. Even White said the analysis was solid, so I doubt anything will change there. The process of peer review etc just takes time though.