PACE Trial and PACE Trial Protocol

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1,446
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http://www.nytimes.com/2011/03/08/health/research/08fatigue.html

'Troubles of Chronic Fatigue Syndrome start with defining it'

‘Defining an Illness Is Fodder for Debate’


David Tuller. New York Times. March 2011

'...Now a new study of chronic fatigue syndrome has highlighted how competing case definitions can lead to an epidemiologic “Rashomon” — what you see depends on who’s doing the looking — and has stoked a fierce debate among researchers and patient advocates on both sides of the Atlantic.

The study, published last month in The Lancet, reported that exercise and cognitive-behavioral therapy could help people with the illness. Advocates and some leading experts dismissed the findings and said the authors’ case definition was largely to blame.

The British scientists who conducted the research identified study participants based largely on a single symptom: disabling and unexplained fatigue lasting at least six months. But many researchers, especially in the United States, say that definition takes in many patients whose real illness is not the syndrome but depression — which can often be eased with psychotherapy and exercise.

The Lancet authors “have written their case definition to include both people with major depressive disorders and patients who clearly have received an insult to their immune systems and are depressed because they can no longer do things that they used to,” said Dr. Andreas Kogelnik, an infectious disease specialist in Mountain View, Calif., who treats many people with chronic fatigue syndrome.'
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Dolphin

Senior Member
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17,567
I have to admit I knew it wasn't a direct quote I was paraphrasing. Thanks for finding the exact quote. However didn't Malcolm Hooper take issue with this response in his magical medicine document and has this been taken up by Tuller and used to the full extent.
FWIW, David Tuller met with Malcolm Hooper:

I would like to thank, as well, Dr. Malcolm Hooper, Margaret Williams, Dr. Nigel Speight, Dr. William Weir, Natalie Boulton, Lois Addy, and the Countess of Mar for their help and hospitality while I was in England researching the story last year. I will always cherish the House of Lords plastic bag that I received from the Countess. (The bag was stuffed with PACE-related reports and documents.)
 

Large Donner

Senior Member
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I don't think one person can do this alone. Wouldn't it make sense for other big hitting advocates to be given room to write PACE critique articles on Virology Blog. Maybe Malcom Hooper and Angela Kennedy?
 

Esther12

Senior Member
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13,774
I don't get the impression that anyone is committed to working alone. It seems that there are lots of different people with different ideas and approaches working in different ways. I think that Tuller knows the people at virology, and they've been following his work enough to know that they want to publish it. That doesn't mean that they're going to want a virology blog to become a home to work from every critic of PACE.
 

Large Donner

Senior Member
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866
I don't get the impression that anyone is committed to working alone. It seems that there are lots of different people with different ideas and approaches working in different ways.

I agree and thats more reason for Hooper and Kennedy to be given a shot at an article or two over there.

I think that Tuller knows the people at virology, and they've been following his work enough to know that they want to publish it.

Thats perfect then he could speak to the people there to get other big hitters to do a couple of articles.


That doesn't mean that they're going to want a virology blog to become a home to work from every critic of PACE.

It gets better then, because I only suggested two of the best ones.
 

Esther12

Senior Member
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13,774
While Angela Kennedy and Malcolm Hooper have both dug up interesting things, I think that too often they can write in a way which puts people off. Also, I've noticed some misleading things in pieces that Hooper has written. They're not the two people I'd choose to be given space on virology.

I wouldn't give myself that space either.
 

Valentijn

Senior Member
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15,786
Is it not the case that the PACE Trial Criteria (they say Oxford) was used to select. Then Fukuda and London were used on (some or all?) of the preselected patients. That Oxford criteria exludes neurological signs and symptoms, so ME patients were likely to have been screened out at the early stage of Oxford selection.
It doesn't explicitly exclude neurological symptoms. But it requires that fatigue be the primary symptom. So many ME patients could be excluded if their primary symptom is PEM, OI, pain, etc.
 

Cheshire

Senior Member
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1,129
http://www.meaction.net/2015/11/06/government-orders-release-of-pace-trial-data/

The Information Commissioner’s Office (ICO) has ordered Queen Mary University of London to release anonymized PACE trial data to an unnamed requester. Queen Mary has 28 days to appeal the decision.

The fear was that the online patient community would take this successfully de-anonymized data and publish it online:

“…must further consider this greater risk presented for identification with this data set from the highly motivated requestor who will likely publish it on a CFS/ME group website, such as Phoenix Rising, where it will be available to all CFS/ME activists seeking to discredit the PACE trial and its researchers, as has been demonstrated, since they do not agree with the PACE trial outcomes.

In his decision, the Commissioner found it was unlikely participants would be identified by anonymized data, even in the case of a “motivated intruder.” He was also not convinced that there is sufficient evidence to determine that releasing the data would result in the mass exodus of a significant number of the trial’s 640 participants nor that it would deter significant numbers of participants from volunteering to take part in future research.
 
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Sidereal

Senior Member
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4,856
I object to the defamatory implications of their choice of the word "activists". Phoenix Rising forum members are simply patients and other interested parties who happen to read and critically analyse the published literature relating to purported treatments for our illness. Why is that a crime?
 

Cheshire

Senior Member
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1,129
How mean they are, unbelievable.

R Horton:
“I think this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment but one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have I would say actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients,”.
This community actively seeks to identify and attack those who are associated with the PACE trial.”

http://www.meaction.net/wp-content/uploads/2015/05/fs_50565190.pdf
 

Valentijn

Senior Member
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15,786
Can we expect new reviews from independent researchers based on the data that will be released?
Well, based on what they're asking for, they should be able to calculate results based on the more rigorous standards which were laid out in the PACE trial protocol:

In order to help ease the burden of staff having to perform the required calculations themselves once the relevant data is located and retrieved, I would like to request the following selection of baseline and 52-week followup data on all 640 individual PACE Trial participants for which the data exists, in a spreadsheetor equivalent file with separate columns for each variable:
• SF-36 physical function scores (range 0-100 points) [baseline and 52-week followup];
• CFQ fatigue Likert scores (range 0-33 points) [baseline and 52-week followup];
• CFQ fatigue bimodal scores (range 0-11 points) [baseline and 52-week followup];
• Oxford criteria CFS caseness (does participant meet criteria, yes or no) [52-week followup only];
• Participant-rated CGI scores (range 1-7) [52-week followup only];
• Doctor-rated CGI scores (range 1-7) [52-week followup only];
• 6MWT walking distances (in meters) [baseline and 52-week followup];
• The group which each participant was allocated to after randomisation (i.e. either to APT, CBT, GET, or SMC).

I think they'd also be able to check how much the "recovered" group actually improved. Did any actually go from SF36-PF scores of 65 down to 60, or stay the same? Could be interesting.
 

Valentijn

Senior Member
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15,786
Why is that a crime?
Sounds like the ICO was wondering the same thing :p

Not that it would even be possible to identify anyone based on the info requested. Though the authors do sound like they're worried about trial participants identifying themselves :confused: I can't even find their explanation for that being any concern whatsoever, though I haven't read it all and just did a search. Maybe they're just throwing in every objection they can think of?
 
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