PACE Trial and PACE Trial Protocol

These people believe in science and medicine, and would be unwilling to accept that the things they teach and value so highly could ever harm. One man in the audience did raise the question of the young girl who recently became so severely damaged following HPV vaccination, and made a plea for truth in the vaccine debate, but his point was ignored by the panel, which went on to other subjects as if they had not heard his question.

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However they did not appear to be part of a conscious conspiracy against PWME!

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Shoot! I was hoping they would be passing out tin foil hats!

thanks for the update. :O)

biophile said:

In April 2011 I sent Horton a 1200 word email explaining the physical function related error made in the paper and editorial (which somehow evaded what Horton called "endless rounds of peer review" on ABC radio), before the authors admitted to this error. I never got any reply except some automated message: "I am on holiday...trying to avoid EuroDisney, but knowing that, in the end, you can't deny a ten-year-old her destiny. I will be back in the office on April 26." Forgot EuroDisney, many of us aren't even well enough to go outside and have to endure reams of psychobabble directed at us from the ivory tower ...

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I never received a real reply of any kind, which by itself doesn't bother me, but later on elsewhere as mentioned on this thread he has made comments which were dismissive and questionable, so I have to wonder how fruitful any further attempts would be at engagement. I don't care how "good" he is supposed to be on other scientific issues, when it comes to ME/CFS he appears to be incompetent and perhaps somewhat unethical, I'm not holding my breath for a significant change regardless of reasonable arguments.

The way all criticism of the PACE Trial has been dismissed using strawmen and redherrings based on the supposed beliefs and agendas of the critics is irritating and disheartening. Don't forget that Horton has played a central role in that dismissal and the attacks on the critics, even blaming us for an alleged 750,000 cost blowout for the PACE Trial.

At least when I sent Zoe Mullan of the Lancet an email about their editorial falsely implying that Hooper's complaint was "now available via Wikipedia" when no such document exists on Wikipedia, there was a response, albeit one which suggests to me the Lancet has wavering interest in accuracy, the email admitted that "Wikipedia" meant a wiki style document on the mecfsforums.com website but a correction was not deemed warranted.

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Well done for trying, anyway.
A few years back, somebody (with a PhD) mentioned that they had become frustrated with Richard Horton - seemed like it was based on some e-mails exchanged. So, it may not be a PACE-specific thing. When something is more long-term, it's probably more likely an attitude that would be harder to change.

BTW, in case anyone missed it, two new pieces in the Lancet today (paper http://forums.phoenixrising.me/show...et-based-CBT-for-CFS-an-RCT-(Nijhof-et-al-12) and editorial http://forums.phoenixrising.me/show...-Trudie-Chalder-CFS-treatment-without-a-cause ).

Hi, I have been interested to read some of these recent comments, as I know nothing about this thread and its issues.

I think the underlying problem is that PWME have been classed as "anti-science" in the minds of this powerful small medical elite. As they are all on first name terms with each other, even though they work in differing areas, we will find it very difficult to challenge this group mindset. I think the prolonged psychiatric campaign against us is responsible for making it impossible for us to gain a fair hearing in the minds of these people because we are ineradicably associated with superstition, ignorance and failure (and lack of effort!) all values they abhor! This prejudice is the achievement of the psyches, and I can see how much damage it has done to our image in the minds of those with power to change our treatment.

I do think it worth approaching Horton, who came acrross as positive, energetic and likeable, but it must be done in ways he and his ilk can approve of - ie it must seem "scientific" Something short and to the point.

Remember that all these people are known to and probably friends with each other. They follow and support each others work. So we are asking one of them to step out of line.

As an illustration, when the audience member asked the question about the girl who had sufferered such a horrendous reaction to HPV vaccination, I saw a look pass between two members of the panel, as if to say "here we go again...." It seemed intolerant and impatient of this man's concern. And as I said, the question was never answered or referred to in any way by any of the panel. But we know that vaccination does on occasion harm recipients. So why do these "enlightened" people have no concern for this girls dreadful situation?
It makes no sense.

If an association of some kind with vaccines is suspected for ME (as an auto-immune disease trigger, or infection from spread of foreign DNA to human recipients) perhaps we are unconsciously thought of by these people committed to medical science and global health as collateral damage in an enterprise that must go forward at all cost.
In that case we are non-persons.

(Remember Lynn Guilderdale developed ME following MMR vaccination, and that was a high profile case which received a lot of publicity.)

Richard Horton opened the discussion with the Duesberg book in his hand saying that it had attacked the HIV / AIDS association and used this book as an example of conspiracy theory that undermines trust in science. He used the metaphor of these ideas (conspiracies) spreading like viral epidemics. So you can see that alternative ideas which appear/are unreasonable are asociated in his mind with disease - an interesting psychological association.
The alternative theory could be merely that - an alternative. Why the association with contamination and fear?

Another attitude I noticed was the love and faith in science, which was a primary motivating force in the lives of these people. Ideas which seen irrational or anti science are going to be despised and condemned. This means they only really trust their own elite. Popular fears would automatically be classed as irrational "conspiracy theories."

There are some underlying problems.

PWME have been classed as ignorant and anti-science
PWME have been classed as "outsiders"

How do we challenge this?
I think by attempting to open a rational and polite debate. By showing we have reason on our side. By keeping any response short - even though the argument is all-important to us, it is only a minor point to them.
By remembering that if we succeed in getting a positive reaction, that person will be at the same time stepping out of line with their colleagues. So dont ask too much.

Thanks for your insights currer. Seems that there's not much point in appealing to people's better nature. Best to continue to get the facts of the science out there.

Does anyone know of a research reference that we can use to say that, at 52 weeks, the outcomes indicate that, on average, participants in all therapy groups were "severely disabled" - using either the SF-36 scores or 6MWDT distances?

mark - much enjoying fingers in the ears to that lot - having escaped with great difficulty their mumbo jumbo.

Bob said:

Does anyone know of a research reference that we can use to say that, at 52 weeks, the outcomes indicate that, on average, participants in all therapy groups were "severely disabled" - using either the SF-36 scores or 6MWDT distances?

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Or phrasing it another way, does anyone know of any way that the average participant scores at 52 weeks (Chalder, SF-36 or 6MWDT) can be described as corresponding to 'severe disability'?

Bob said:

Does anyone know of a research reference that we can use to say that, at 52 weeks, the outcomes indicate that, on average, participants in all therapy groups were "severely disabled" - using either the SF-36 scores or 6MWDT distances?

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There are probably ways. Too busy now to do directly but this published letter can be referenced to say SF-36 PF levels are equivalent to population norms for people 40 years older: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60685-5/fulltext

Thank you Dolphin...

Dolphin said:

There are probably ways. Too busy now to do directly but this published letter can be referenced to say SF-36 PF levels are equivalent to population norms for people 40 years older: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60685-5/fulltext

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Just so no one else gets confused: Dolphin said 40 years 'older' (older than the particpants in PACE Trial), not 40 years 'old'.

Hi Bob. Not sure if this is what you wanted, but ...

PF/SF-36

It is ironic and annoying how Bleijenberg, one of the authors of the accompanying editorial, praised the PACE Trial's supposed "strict criterion for recovery" (including a physical function score of ?60/100 points which on average no treatment group achieved) while previously co-authoring a 2010 paper which stated that "A cut-off of ?65 was considered to reflect severe problems with physical functioning." (http://eurpub.oxfordjournals.org/content/20/3/251.full.pdf). Amazing how a patient can be recovered with severe problems in function!

From Bowling et al 1999 (http://jpubhealth.oxfordjournals.org/content/21/3/255.full.pdf), a general population which included the elderly and diseased, used by PACE to define "normal" physical function ...

Cut down on activities because of illness (in last 2 weeks):
Yes = 63.0 33.4
No = 87.7 20.2

Long term health problem:
Yes = 52.3 28.9
No 92.7 13.1

35-44 years age bracket (similar age as most PACE Trial participants) = 93.3 13.4
75-84 years age bracket = 57.9 28.6 (similar scores to PACE Trial participants after therapy, as Dolphin suggested)

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From Jenkins et al 1993 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1677870/pdf/bmj00022-0017.pdf), cited in the earlier PACE protocol along side Bowling et al 1999 ...

Respondents reporting long standing illness: 78.3 23.2

Respondents not reporting long standing illness: 92.5 13.4

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In a study of 51 community-dwelling patients (average age 71 5 years) with established chronic coronary heart disease, the average physical function score was 68 19 points, making them less disabled on average than all therapy groups post-treatment in the PACE Trial despite the latter being 30 years younger on average (http://archinte.ama-assn.org/cgi/reprint/159/19/2357.pdf).

In a study of 303 patients with coronary heart disease (described by the authors as "a major cause of disability") undergoing cardiac rehabilitation and aged about 60 years, baseline physical function scores was on average 66 23 points and increased to 80 20 points (http://archinte.ama-assn.org/cgi/reprint/159/19/2357.pdf).

In a study of resistance training for 25 patients described as "older disabled women with coronary heart disease", baseline physical function scores for the intervention group was 61.9 20.6 points and for the control group was 70.4 12.9 points (http://jap.physiology.org/content/92/2/672.full.pdf). Also note table 2 where average 6MWD scores were at all times higher than PACE Trial participants (http://jap.physiology.org/content/92/2/672/T2.expansion.html).

In a study of kidney transplant candidates, baseline physical function scores for 366 patients who later received transplants was 62.3 24.5 points (http://cjasn.asnjournals.org/content/1/4/837.full.pdf) In a review of physical functioning in end-stage renal disease patients (http://www.healthsystem.virginia.edu/pub/renal-services/exercise/painter-review-2005.pdf), Figure 2 presents the following scores adapted from Ware et al 1994: general population = 84; COPD (chronic obstructive pulmonary disease) = 50; CHF (congestive heart failure) = 56; MI (myocardial infarction) = 69; HD (hemodialysis) = 50.

6MWD

I have many comparisons for this, but two which provide good context for where PACE Trial participants are scoring, starting out as impaired as a general elderly cohort aged 774yrs and finishing up as impaired as patients with serious cardiopulmonary disorders.

34488m (n=2117) - a general elderly cohort aged 774yrs (60% female) who completed the 6MWT http://chestjournal.chestpubs.org/content/123/2/387.full.pdf

393115m (n=1083) - patients from 11 studies on a diverse range of cardiopulmonary disorders: end stage lung disease, dilated cardiomyopathy, congestive heart failure, pulmonary hypertension, chronic obstructive pulmonary disease, interstitial lung disease; [range, 294139m (ESLD) to 463107m (DC)] http://www.biomedcentral.com/content/pdf/1471-2466-10-31.pdf

Thanku for all the info biophile.

I've got everything I need now...

Thank you everyone.

Some people interested in the PACE Trial might be interested in this London paper which uses a lot of the same measures:

The effect of counselling, graded exercise and usual care for people with chronic fatigue in primary care: a randomized trial.
http://forums.phoenixrising.me/show...se-and-usual-care-for-people-with-CF-Ridsdale

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I can recommend a little counselling from my GP who reluctantly had to admit I was not bonkers.

Earlier versions of the trial manuals and identifier can be found in a new thread here: http://forums.phoenixrising.me/show...uals-trial-identifier-etc&p=246753#post246753

Thought that they may be of interest to others reading this thread.

Dolphin posted this on another thread (my bolding)...

Dolphin said:

This was in their own newsletter:

How many patients improved and how many were back to normal?

Around six out of ten patients made an improvement in both fatigue and physical ability after CBT
or GET, compared to four out of ten patients who improved with APT or SMC. The number of patients
returning to normal levels of fatigue and physical function was about three out of ten after
CBT or GET; about twice as many as those who received APT or SMC.

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

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I was wondering if Dolphin or anyone else knows which results they might be refering to here?

I can't think of any figures in the PACE Trial where 6 out of 10 participants in the CBT/GET groups improved, and 4 out of 10 participants in the APT/SMC groups improved.

Any ideas?



They've got the same figures in the FAQ's on the PACE Trial website:

FAQ2

http://www.pacetrial.org/faq/faq2.html

Approximately 12 out of 20 patients made a clinically useful reduction in fatigue and improvement in functioning with either CBT or GET compared to about 8 out of 20 with APT and 9 out of 20 with SMC.

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Just from memory, doesn't that refer to their definition of a clinically significant improvement? It was a pretty minimal change from what I recall, and they could well have rounded the figures to get 6/10.

42% in the APT group improved by at least 2 points for fatigue and at least 8 points (isn't 8 impossible? doesn't it have to be 5 or 10?) for physical function at 52 weeks, compared with 59% for CBT etc.

Page 9, bottom left paragraph.

Tattoo'ed on this sad man's brain.

Knowing the ups and downs through this illness do any of these "improvements" persist one wonders - are they permanent or a sort of flash in the pan at a certain stage ? I do recall at all stages walking about (however little) did help. Guessed moving about (if one can) must improve things like any other illness.

Much appreciate your sad man's brain Graham.