PACE Trial application to MRC for funding in 2002

J

JohnTheJack

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I asked the MRC for the application form. I received a heavily redacted version and asked them to review.

I have now received a somewhat less redacted version.

I note Wessely named as collaborator and that AfME sent a letter in support of the trial (redacted).

Any thoughts on whether it's worth appealing to the ICO for any of the redacted information?

https://www.dropbox.com/s/irrd19retjtmnzl/R - PACE Trial application 070218.pdf?dl=0
 
Thanks for that John.

I don't know whether appealing to the ICO would be a good use of your time. Have you contacted Action for ME about this? Maybe you could ask them for a copy, emphasise that it's only by getting this stuff out in the open that people will ever be able to "move on" (as their trustees put it).

Other redactions it would be good to get:

Info on the suggested referees would be good to get, and the proposed TSC and Data and Ethics monitoring committees.

Would also be good to get the letters of support from appendix 12 & 13. Do you know if they were deliberately omitted, or just happened to not be a part of that file?


I quickly skimmed through, and made a few notes:

More talk of need for a 'definitive study' on page 4. There's a brief summary of CBT/GET/APT in that 'public engagement in science' section... although nothing about public engagement in science.

Also on page 4 it says that personal information is anonymised.

I'm not really sure what it means on that page when it says that it does not involve experimentation on human participants.

On page 9 it says that the DWP was funding a White project with Dr WT Hamilton & Ms JM Thomas: "A case-control study of the incidence, predictions and associations of the general practitioners record". I'm not sure if I know what that is, or if I knew of the DWP having funded this earlier White work.

I skimmed over a lot that seemed to be the same as documents already made public, eg the CBT manual co-authored by Wessely.

p104 talks about the involvement of the Clinical Trials Unit directed by Wessely.
 
Their 'consumables' costs are on p19, with some bits of minor interest. [edit: I should add that these were just proposed costs, not confirmed ones after the trial had taken place]

Has Action for ME consultancy costs at £4,312.

Also, three payments of £15,080 for a redacted cost - payment to the three Principal Investigators?

£30,030 to the CTU for database/randomisation.

£1,800 on Birthday/Christmas cards.
 
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Esther12 said:
I'm not really sure what it means on that page when it says that it does not involve experimentation on human participants.

On page 9 it says that the DWP was funding a White project with Dr WT Hamilton & Ms JM Thomas: "A case-control study of the incidence, predictions and associations of the general practitioners record". I'm not sure if I know what that is, or if I knew of the DWP having funded this earlier White work.
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Here is the study or one of them.

J R Soc Med. 2004 Dec;97(12):571-5.
Incidence of fatigue symptoms and diagnoses presenting in UK primary care from 1990 to 2001.
Gallagher AM1, Thomas JM, Hamilton WT, White PD.
Author information

Erratum in
  • J R Soc Med. 2005 Feb;98(2):88.
Abstract
Little is known about whether the incidence of symptoms of fatigue presented in primary care, and the consequent diagnoses made, change over time. The UK General Practice Research Database was used to investigate the annual incidence of both fatigue symptoms and diagnoses recorded in UK primary care from 1990 to 2001. The overall incidence of all fatigue diagnoses decreased from 87 per 100 000 patients in 1990 to 49 in 2001, a reduction of 44%, while postviral fatigue syndromes decreased from 81% of all fatigue diagnoses in 1990 to 60% in 2001. Chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) together increased from 9% to 26% of all fatiguediagnoses. The incidence of fibromyalgia increased from less than 1 per 100 000 to 35 per 100 000. In contrast, there was no consistent change in the incidence of all recorded symptoms of fatigue, with an average of 1503 per 100 000, equivalent to 1.5% per year. CFS/ME and fibromyalgia were rarely diagnosed in children and were uncommon in the elderly. All symptoms and diagnoses were more common in females than in males. The overall incidence of fatigue diagnoses in general has fallen, but the incidence rates of the specific diagnoses of CFS/ME and fibromyalgia have risen, against a background of little change in symptom reporting. This is likely to reflect fashions in diagnostic labelling rather than true changes in incidence.

Comment in
Click to expand...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1079668/

Acknowledgments
This study was funded by the Department for Work and Pensions. WTH is funded through RCGP/BUPA and NHS Fellowships. We thank Dr Irene Petersen for advice and help.
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Esther12 said:
Thanks for that John.

Have you contacted Action for ME about this? Maybe you could ask them for a copy, emphasise that it's only by getting this stuff out in the open that people will ever be able to "move on" (as their trustees put it).
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Sure. It would be interesting to see that. It had also occurred to me to ask AfME. Though I have a feeling that their idea of 'moving on' is to keep everything to do with their involvement as hidden as possible.

Esther12 said:
Info on the suggested referees would be good to get, and the proposed TSC and Data and Ethics monitoring committees.
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I think that may be difficult as they weren't in fact anything to do with the trial.

Esther12 said:
Would also be good to get the letters of support from appendix 12 & 13. Do you know if they were deliberately omitted, or just happened to not be a part of that file?
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My understanding is that they were not part of the file (and hence not redacted).

Esther12 said:
Also, three payments of £15,080 for a redacted cost - payment to the three Principal Investigators?
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No, that wouldn't be redacted. My guess would be that those payments were not in fact made, or were made to someone other than those named in the application.

It is interesting about the AfME consultancy. And that they sent the trial participants birthday and Christmas cards. Waste of money.
 
Esther12 said:
Their 'consumables' costs are on p19, with some bits of minor interest. [edit: I should add that these were just proposed costs, not confirmed ones after the trial had taken place]

Has Action for ME consultancy costs at £4,312.

Also, three payments of £15,080 for a redacted cost - payment to the three Principal Investigators?

£30,030 to the CTU for database/randomisation.

£1,800 on Birthday/Christmas cards.
Click to expand...

Also the costs on actiwatch are listed (and software) which they then abandoned as an outcome.
 
JohnTheJack said:
I asked the MRC for the application form. I received a heavily redacted version and asked them to review.

I have now received a somewhat less redacted version.

I note Wessely named as collaborator and that AfME sent a letter in support of the trial (redacted).

Any thoughts on whether it's worth appealing to the ICO for any of the redacted information?

https://www.dropbox.com/s/irrd19retjtmnzl/R - PACE Trial application 070218.pdf?dl=0
Click to expand...

James said:
I was not on the ship, neither as passenger or crew. I helped recruit some patients to the study from our clinic, as did many doctors, but that was as far as it went.
https://www.nationalelfservice.net/...syndrome-choppy-seas-but-a-prosperous-voyage/
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Wessley as collaborator? Well that's a new revelation. Even above he forgot to mention that he had been involved in study design or something like that (I forget the exact words) which was mentioned somewhere else - in the thank you list of one of the PACE papers?
 
JohnTheJack said:
It is interesting about the AfME consultancy. And that they sent the trial participants birthday and Christmas cards. Waste of money.
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I was thinking about these Birthday and Christmas cards.

What message was sent along with them?
Did they include thanks to the participants for being part of such a great great trial?
Did they tell participants how the therapies were proving such a success?

I wonder.
Does anyone know?
 
I went back to the MRC and checked some of the redactions. They said:

  • On pages 12 and 13 the name of a Research Assistant intended to work of the study has been redacted. Research Assistants are generally junior positions and the name has been withheld under section 40(2) of the Freedom of Information Act. The same person is named on pages 12 and 13.
  • The names redacted from pages 15, 16, 17, 18 and 19 all relate to named investigators and collaborators. The redactions should have been lifted in providing a revised version of the application form to you last week. We apologise for this oversight and a revised copy of the application form with these redactions removed will be sent to you shortly.


I have now been sent a new version with some of those redactions removed.
https://www.dropbox.com/s/gdcdwlj4kyq3x2t/R - PACE Trial application 150218.pdf?dl=0
 
I appealed the MRC's redaction of the AfME letter in support of PACE. In light of my complaint to the ICO, the MRC has reconsidered its decision and has now released the letter.

It's not all that interesting. It seems to be simply that as long as pacing is included, Clark would support the application.


ETA: 'AfMe' before 'letter'
 

Attachments

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chrisb said:
That letter seems quite helpful to Afme, but might be regarded as placing an onus on the researchers to give pacing a proper "run for its money".

Everyone will no doubt have a view as to whether the duty was adequately discharged.
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I agree. I don't think in itself it puts AfME in a particularly bad light. The problem is that he/they seemed to think so long as pacing (or rather the PIs' definition of pacing) was included they'd support the trial to the extent they did. They should have looked more closely at the whole design of the trial.
 
Well done JtJ. Nothing shocking in that letter but hopefully a lesson for AfME and other organizations not to be so willing and trusting in situations where they're asked to support such a thing in future. Seems very naive. I'd hope organizations are more professional nowadays and would scrutinize more carefully and attach appropriate conditions in similar circumstances. No idea if that's true or not.
 
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