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PACE Trial and PACE Trial Protocol

B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Dolphin said:
If you've a specific paper to discuss, please set up the thread. Having threads on particular papers is very handy for lots of people.
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Thanks Dolphin. I did set up a thread on the Cochrane Review, some time ago, but it didn't attract any interest, so I wondered if I was replicating other discussions that I hadn't seen. I couldn't find any substantial discussions of Cochrane, with a forum search. And I wondered if any other CBT reviews had already been discussed. Are you aware of any discussions?
 
D

Dolphin

Senior Member
Messages
17,567
Bob said:
Thanks Dolphin. I did set up a thread on the Cochrane Review, some time ago, but it didn't attract any interest, so I wondered if I was replicating other discussions that I hadn't seen. I couldn't find any substantial discussions of Cochrane, with a forum search. And I wondered if any other CBT reviews had already been discussed. Are you aware of any discussions?
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There's a thread on:
Cognitive Behavioral Therapy and Graded Exercise for CFS: A Meta-Analysis (Castell)

http://forums.phoenixrising.me/index.php?posts/229430/

Most/nearly all of the threads that have been set up are on papers that have come out since this forum was set up.
 
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
On another thread, Firestormm pointed out that we do actually now have a way to assess how useful and meaningful the 'moderate' improvements were...
The 'moderate' improvements failed to improve lost-working hours, and failed to decrease benefits claims, and failed to decrease private financial claims.
So now we know exactly how useful the 'moderate' improvements are!

Firestormm said:
... to get 40% [my correction: 11-15% maximum] of people feeling a bit better but not to return to work or come off of benefits - is a ruddy financial disaster.
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B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Graham said:
Thanks for the note about the BMJ campaign. I have written to Fiona Godlee and Trish Groves thanking them, and drawing attention to our concerns over the PACE trial.
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I can't help feeling that their 'campaign' applies to all medical trials, except the PACE Trial.
(Obviously the PACE Trial is beyond all possible reproach :rolleyes:)

But I'm sure that they will appreciate your email, esp as you mentioned the PACE Trial! :)
 
Simon

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
Graham said:
Thanks for the note about the BMJ campaign. I have written to Fiona Godlee and Trish Groves thanking them, and drawing attention to our concerns over the PACE trial.
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That's an inspired idea. Bob's probably right, but definitely worth a shot.
 
Esther12

Esther12

Senior Member
Messages
13,774
It probably would be worth collecting relevant quotes somewhere. I've seen a few around, but never done anything with them. It is quite funny to have this move towards recognising the problems with statistical manipulation and deviations from protocols coming from those who otherwise seem to want to pretend that the problems patients have with the PACE trial is that we're just anti-science, or anti-psychiatry.
 
Graham

Graham

Senior Moment
Messages
5,188
Location
Sussex, UK
Following the reply to the Countess of Mar (pasted below), I have written again to Dr Godlee of BMJ to draw her attention to this, and explained our concerns over their standards for "recovery". We can but hope.



Health: Controlled Trials

Question

Asked by The Countess of Mar
To ask Her Majesty's Government whether the refusal by researchers to publish trial data on recovery rates and positive outcome rates specified in their application for grant funding provided by the Department of Health, the Medical Research Council, the Scottish Office and the Department for Work and Pensions for "Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial" contravenes the agreement the researchers entered into when the award was made.[HL3151]
The Parliamentary Under-Secretary of State, Department for Business, Innovation and Skills (Lord Marland):The PACE trial: A Randomised Controlled Trial of CBT, graded exercise, adaptive pacing and usual medical care for the chronic fatigue syndrome, was funded by a Medical Research Council (MRC) grant to Queen Mary, University of London.​
While the MRC strongly encourages the publication and dissemination of the findings of all MRC-funded research it does not require the publication of underlying research data. As an MRC grant, the study was subject to the RCUK (Research Council UK) and MRC terms and conditions; no additional requirements around publication were specified by the other funders of the study.​
The findings of the PACE study have been reported in The Lancet, in March 2011 (published online in February 2011) and in PLOS ONE in August 2012. These papers included the results of analyses of positive outcome rates.​
The MRC is aware that Queen Mary University London received a request under the Freedom of Information Act relating to data on recovery rates and positive outcome rates which relates to an analysis initially planned by the investigators in the original protocol for the study and which was published in 2007. It is understood that the request was declined by the university as this originally planned analysis was superseded and therefore not undertaken during the study.​
 
D

Dolphin

Senior Member
Messages
17,567
I have just been reading, "Keeping patients safe while avoiding bias in randomised trials" http://www.bmj.com/content/344/bmj.e3297

It mentions:

Thus, a data safety and monitoring board will make recommendations to the trial steering committee and may recommend that a trial’s design is stopped or modified either to avoid harm to patients or when there is convincing evidence of benefit. Alternatively, the board may simply state that the trial can continue as planned. Even if the monitoring board noticed that some aspect of the conduct of a trial (such as the choice of primary outcome) militated against the trial achieving its scientific goal, the board should not advise a change because this would introduce bias.4

4. Tharmanathan P, Calvert MJ, Hampton J, Freemantle N. The use of interim data and data monitoring committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias. BMC Med Res Method2008;8:12.
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This latter paper is free at: http://www.biomedcentral.com/content/pdf/1471-2288-8-12.pdf

Although the scenario isn't exactly the same, on a quick skim, it does talk about the problem of changing outcome measures, so could be useful.
 
Marco

Marco

Grrrrrrr!
Messages
2,386
Location
Near Cognac, France
The paper referenced in this thread, while interesting in it own right, has a very useful discussion of the impact of and how to properly measure placebo effects :

http://forums.phoenixrising.me/index.php?threads/placebo-effect-may-be-genetic.20878/

Catechol-O-Methyltransferase val158met Polymorphism Predicts Placebo Effect in Irritable Bowel Syndrome

Including concepts such as the need to include a 'waiting list control' to be able to exclude the natural disease progression and reversion to the mean and the impact of 'augmented placebo' on outcomes.

Enjoy!
 
D

Dolphin

Senior Member
Messages
17,567
Graham said:
Following the reply to the Countess of Mar (pasted below), I have written again to Dr Godlee of BMJ to draw her attention to this, and explained our concerns over their standards for "recovery". We can but hope.



Health: Controlled Trials

Question

Asked by The Countess of Mar
To ask Her Majesty's Government whether the refusal by researchers to publish trial data on recovery rates and positive outcome rates specified in their application for grant funding provided by the Department of Health, the Medical Research Council, the Scottish Office and the Department for Work and Pensions for "Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial" contravenes the agreement the researchers entered into when the award was made.[HL3151]
The Parliamentary Under-Secretary of State, Department for Business, Innovation and Skills (Lord Marland):The PACE trial: A Randomised Controlled Trial of CBT, graded exercise, adaptive pacing and usual medical care for the chronic fatigue syndrome, was funded by a Medical Research Council (MRC) grant to Queen Mary, University of London.
While the MRC strongly encourages the publication and dissemination of the findings of all MRC-funded research it does not require the publication of underlying research data. As an MRC grant, the study was subject to the RCUK (Research Council UK) and MRC terms and conditions; no additional requirements around publication were specified by the other funders of the study.
The findings of the PACE study have been reported in The Lancet, in March 2011 (published online in February 2011) and in PLOS ONE in August 2012. These papers included the results of analyses of positive outcome rates.
The MRC is aware that Queen Mary University London received a request under the Freedom of Information Act relating to data on recovery rates and positive outcome rates which relates to an analysis initially planned by the investigators in the original protocol for the study and which was published in 2007. It is understood that the request was declined by the university as this originally planned analysis was superseded and therefore not undertaken during the study.
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This last paragraph makes it sound like it is impossible to get the data, that this data wasn't collected during the study and thus can't be given.

This is totally incorrect. It is not like some study where the researchers decided to take a measurement and then changed their mind and decided not to take the measurement before the study started. These things were measured all the way through the study but after the study was finished, the investigators decided to not to calculate the answers.

I wonder were Lord Marland and his department misled? That would be serious I would have thought.

Either way, it seems to me that the response given in the House of Lords is a bit misleading.
 
Graham

Graham

Senior Moment
Messages
5,188
Location
Sussex, UK
That's interesting Dolphin. I read the word "analysis" to mean "calculation", and so interpreted it as "we didn't do this particular calculation because we chose to do a different one". But I now see that there are other ways of reading it that are misleading, suggesting that the FOI request would have been impossible to answer. The use of the word "during" is clearly the weasel word. There's a lot of that in various statements by the psychosocial brigade. No wonder they can claim that they never meant this or never said that.
 
D

Dolphin

Senior Member
Messages
17,567
FWIW:

http://online.wsj.com/article/SB10001424127887324705104578147333270637790.html


In American corporations, perhaps the most widely accepted doctrine of the "cult of positivity" is the importance of setting big, audacious goals for an organization, while employees are encouraged (or compelled) to set goals that are "SMART"—"Specific, Measurable, Attainable, Relevant and Timely." (It is thought that the term was first used in a 1981 article by George T. Doran.)

But the pro-goal consensus is starting to crumble. For one thing, rigid goals may encourage employees to cut ethical corners. In a study conducted by the management scholar Lisa Ordóñez and her colleagues, participants had to make words from a set of random letters, as in Scrabble. The experiment let them report their progress anonymously—and those given a specific target to reach lied far more frequently than those instructed merely to "do your best."
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-----
@Maxwhd (Twitter) pointed out this is used in CBT manual for PACE Trial: http://www.pacetrial.org/docs/cbt-therapist-manual.pdf


LONG-TERM TARGET RECORD

Please write down below a few targets that you would like to work towards during your
course of CBT. As well as ensuring that you have a variety of targets to work towards
including some pleasurable ones, try to make your targets SMART!

• Specific - stating exactly what, how much, when, where and with whom
• Measurable - how far, how long for and how often
• Achievable - Are the targets realistic?
• Relevant - Are the targets relevant to your life?
• Time-related - The targets have a specific time-frame
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D

Dolphin

Senior Member
Messages
17,567
http://www.actionforme.org.uk/get-i.../pace-motion-tabled-for-short-dabate-in-lords

PACE: motion tabled for short debate in Lords
12 December 2012
The following motion was tabled in the Lords on 12 December 2012 for short debate:
The Countess of Mar to ask Her Majesty’s Government what assessment they have made of the effects of the PACE trial (Pacing, graded Activity and Cognitive behaviour therapy: a randomised Evaluation) on provision of health and social care and welfare benefits for people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
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