PACE Trial and PACE Trial Protocol

alex3619

alex3619

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My mistake Bob, I was also reading another article on the same issue: http://www.bbc.co.uk/news/uk-20858353

Its got a broader scope though.

Hmm, no, that isn't the right one either. I have read a few of these today. I got my threads mixed up. I was commenting on this one: http://therenodispatch.blogspot.ie/2012/12/bombshell-exclusive-scientists-link_13.html

This is about the current view that most cases of GWS are due to sarin gas. The real probability of this happening has now been at least somewhat accepted. So of course if sarin is responsible, then its not psychiatric.

This was of course from another post by you here: http://forums.phoenixrising.me/inde...hood-for-his-work-for-gws-and-me.21116/page-3
 
D

Dolphin

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I just, very belatedly, read:


Professor Malcolm Hooper’s further concerns about the PACE Trial article published in The Lancet -24thJune 2011​

http://www.meactionuk.org.uk/Normal-fatigue.htm
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I think it does a good job of explaining why not publishing the positive outcome measures is important along with why the thresholds for "normal" fatigue and functioning used in the Lancet paper are unsatisfactory.
Virtually all of it, I knew before.

One point caught my eye:

First, the cited reference for the benchmark chosen to assess PACE outcomes, co-authored by the PACE Trial Principal Investigator Trudie Chalder, also provides bimodal scores for the same population: “community sample: mean fatigue 3.27 (S.D. 3.21)". This places the ceiling at which a person can have fatigue and still be considered within the normal range at a bimodal score of 6.

This is inconsistent with the PACE Trial literature, which repeatedly refers to “a score of 4 having been previously shown to indicate abnormal fatigue” (see above), citing a paper lead-authored by Trudie Chalder and co-authored by Director of the PACE Trial Clinical Unit and member of the Trial Management Group Professor Simon Wessely.
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The study with the mean fatigue 3.27 (SD: 3.21) in bimodal scoring is :

Measuring fatigue in clinical and community settings.
Cella M, Chalder T.
J Psychosom Res. 2010 Jul;69(1):17-22. doi: 10.1016/j.jpsychores.2009.10.007. Epub 2009 Dec 11.
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i.e. the study where, with "Likert" scoring, the community sample had a mean of 14.2 (SD 4.6).

So, in case it's unclear, the point being made is that if one uses the formula of mean + 1 SD, with the Cella/Chalder data, the threshold for normal fatigue is 6.48 on the Chalder fatigue scale. This is very different from the validated threshold of 3 normal/4 abnormal fatigue in the study mentioned in the PACE Trial protocol:
Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, et al. Development of a fatigue scale. J Psychosom Res 1993;37:147–53.
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This suggests one of two things. Either
(i) the two fatigue studies found quite different mean (SDs) (it is a pity we don't have such details for the 1993 study - at least, I presume that is the case)
or
(ii) the formula mean+1SD is not good to work out thresholds, because that formula gives 6.48 but when actually trying to look for a criterion for normal fatigue (i.e. using another questionnaire), the threshold is 3 or less (i.e. the mean + 1SD formula should give a number between 3 and 4)
 
D

Dolphin

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Not specific to the PACE Trial but thought I'd post this term which is new to me:

http://en.wikipedia.org/wiki/Woozle_effect

Woozle effect, also known as evidence by citation,[1] or a woozle, occurs when frequent citation of previous publications that lack evidence mislead individuals, groups and the public into thinking or believing there is evidence, and nonfacts become urban myths and factoids.[2] Woozle effect is a term coined by Beverly Houghton in 1979.[3][4][5] It describes a pattern of bias seen within social sciences and which is identified as leading to multiple errors in individual and public perception, academia, policy making and government. A woozle is also a claim made about research which is not supported by original findings.[6]
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Graham

Graham

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Did you all cotton on to the Winnie-the-Pooh reference? He follows some tracks, then finds two sets, then three ..., and decides that he is following a Woozle, when in fact they are his own footprints.

Woosles and Heffalumps are Pooh talk for weasles and elephants.

I only live a few miles away from the home of Winnie-the-Pooh! And it is about my mental level. And I like honey.
 
D

Dolphin

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http://www.bacme.info/document_uploads/events/PROGRAMME.pdf


CFS/ME SERVICE AT ST BARTHOLOMEW’S HOSPITAL
LMDT Training
Pain and CFS
Dec 3.
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This included:

12:00-12:30
Pain in PACE (PACE Trial analysis)
Dr Julius Bourke
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Very little was included in the Lancet paper on pain so I'm guessing new data was presented. I wonder will this ever be published?

By the way, earlier, he also gave another talk which suggests there was new data shared:
10.00 to 11.00
Central mechanisms of pain in CFS
Dr Julius Bourke
Clinical Lecturer and Honorary Consultant Psychiatrist
Queen Mary’s School of Medicine and Dentistry London
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Might be worth a FOI request, at some stage, perhaps not now. I don't live in the UK so not the best to be doing them I think.
 
B

Bob

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I've just been thinking about objective measures: the six minute walking distance test (6MWDT) and lost employment.

For SMC-alone there were improvements in both the 6MWDT, and lost employment.
But for CBT and GET there were no further significant improvements in either the 6MWDT, or lost employment. (Except for GET/6MWDT, for which there was no 'clinically useful' improvement, and data was not given for a third of participants, which suggests that a good proportion may have dropped out of the test.)

So these results are a double-whammy for the hypothetical psycho-social model of illness:
If patients are 'fearful' of activity (based on maladaptive illness-beliefs etc., so they avoid activity, leading to deconditioning) then why did SMC-alone lead to improvements in objectively-measured activity/disability, when SMC does not treat or address either 'fear' or 'deconditioning'? (This suggests that patients take on more activity when the symptoms/illness allow, regardless of illness-beliefs and fear.) When, in comparison, CBT/GET, the therapies that were designed to address the 'fear' and 'deconditioning' etc., led to no meaningful improvements for the objective measurements? (This result, for CBT/GET demonstrates that it is not fear or deconditioning that is holding patients back, but other issues.)

Put together, the separate results for both SMC and CBT/GET, for the objective measures, invert the hypothesis, and turn it on its head!

If the hypothetical psycho-social model of illness had been successfully proved, the results would have been the other way around. (The results for CBT/GET would have been greater than for SMC.)

The model has been disproved.
 
alex3619

alex3619

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Logan, Queensland, Australia
Dolphin said:
Not specific to the PACE Trial but thought I'd post this term which is new to me:

http://en.wikipedia.org/wiki/Woozle_effect
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Darn, the Woozle effect. Here I was thinking I was onto something new, though I have come across citation bias before. Thanks Dolphin. Yes, I see this pattern in the psychogenic literature. Its a real worry when some of it even goes back to C19th discredited literature on neurasthenia for justification.

If you track psychogenic literature back to the time of Charcot, there is NO objective medical evidence that shows psychogenic illness exists. Everything is subject to alternative explanations. Yet they cite and cite and cite each other, creating a large body of published papers resting on an illusion of substance.

More recently there has been a focus on measuring secondary evidence such as treatment effectiveness. This is an attempt to ligitimize the nonscience. Its also a characteristic hallmark of pseudoscience. Its a very small divide from such science and pseudoscience, and where that divide is placed is considered very controversial. Historically there are examples where it started as science then the line moved and it became pseudoscience. I think that is happening in psychogenic medicine.

Bye, Alex
 
D

Dolphin

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The PACE Trial team said this in an e-letter: http://www.biomedcentral.com/1471-2377/7/6/comments#306608
Beliefs and expectations of treatment and who is running the trial
The trial has been designed and is being managed by many different healthcare and research professionals, including doctors, therapists, health economists, statisticians and a representative of a patient charity. The Trial Management Group includes five physicians and four psychiatrists. To measure any bias consequent upon individual expectations, all staff involved in the PACE trial recorded their expectations as to which intervention would be most efficacious before their participation, and we will publish these data after the end of the trial.
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I'm pretty sure this hasn't been published. Can anyone remember any talk of the results in recent years.
 
B

Bob

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Dolphin said:
The PACE Trial team said this in an e-letter: http://www.biomedcentral.com/1471-2377/7/6/comments#306608
Beliefs and expectations of treatment and who is running the trial
The trial has been designed and is being managed by many different healthcare and research professionals, including doctors, therapists, health economists, statisticians and a representative of a patient charity. The Trial Management Group includes five physicians and four psychiatrists. To measure any bias consequent upon individual expectations, all staff involved in the PACE trial recorded their expectations as to which intervention would be most efficacious before their participation, and we will publish these data after the end of the trial.
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I'm pretty sure this hasn't been published. Can anyone remember any talk of the results in recent years.
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I don't remember seeing it anywhere, but I would probably dismiss something like that as meaningless if the results looked fixed. But seeing as they all expected CBT and GET to be wonderful, and APT and SMC to be useless, I would probably remember any results that reflected those expectations, if I had seen them.
 
D

Dolphin

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A new paper is on its way:


Sat 19/1/13.

http://www.independent.co.uk/voices...-online-postings-13-january-2013-8449260.html

John Maddox Prize:

We would like to correct several errors of fact in the letter published on this website by the Countess of Mar and others. These authors state that we "..have promoted an hypothesis that ME/CFS is due to an abnormal illness beliefs,.. " We have not; beliefs about an illness determine the ways people cope with it, but this has little to do with how the illness develops in the first place (its immediate cause), which our own research has shown can follow certain infections.

The correspondents also mention the PACE trial and state that "No data on recovery rates and positive outcomes have been released.." The results of positive (and negative) outcomes were published in the Lancet medical journal early in 2011. The results of recovery rates are due to be published in the medical journal Psychological Medicine within the next three weeks.

The authors state that "There has been no attempt by Professor White to correct the misapprehension in respected journals as well as the popular press that the PACE trial demonstrated recovery rates of between 30% and 40%." Again this is not the case; Prof White and colleagues published the following in the Lancet in May 2011: "It is important to clarify that our paper did not report on recovery; we will address this in a future publication."

The PACE trial has added to the now overwhelming scientific literature showing that two rehabilitative approaches of cognitive behaviour therapy and graded exercise therapy are moderately effective treatments of what is otherwise a chronic, debilitating and untreatable illness that blights patient's lives. This is good news that needs sharing.

Professor Peter White
Professor Sir Simon Wessely
Queen Mary University London
and King's College London
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V

Valentijn

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The results of positive (and negative) outcomes were published in the Lancet medical journal early in 2011.
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I thought the issue was more that adverse events hadn't been released.

The results of recovery rates are due to be published in the medical journal Psychological Medicine within the next three weeks.
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Does this mean breaking down how many improved or worsened X points, versus group averages?
 
D

Dolphin

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