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PACE Trial and PACE Trial Protocol

John Mac

Senior Member
Messages
321
Location
Liverpool UK
Interesting article on the BBC website about the meteorite that wiped out the dinosaurs.
Scientists have been drilling at the site to bring up core samples to study.

http://www.bbc.co.uk/news/science-environment-36377679

What struck me in the article was this:

"The scientists get a year's exclusive access to the material, after which others in the research community can take a look."

Clearly they are not afraid to share their data. Real science in action. ;)
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
via @Tom Kindlon on Twitter.

Latest PACE publication...

Complementary and alternative healthcare use by participants in the PACE trial of treatments for chronic fatigue syndrome.
Lewith G, Stuart B, Chalder T, McDermott C, White PD.
Journal of Psychosomatic Research 2016;87:37-42.
10 June 2016.
http://www.jpsychores.com/article/S0022-3999(16)30327-0/abstract
http://www.sciencedirect.com/science/article/pii/S0022399916303270

Highlights
  • CAM use is very common in patients with chronic fatigue syndrome (CFS) involving approximately two thirds of patients.
  • Its use is not associated with any important clinical outcomes.
  • The main predictors of CAM use are female sex and local ME group membership.
  • These observations are important for clinicians and should be discussed with CFS patients.

Abstract
Background
Chronic Fatigue Syndrome (CFS) is characterised by persistent fatigue, disability and a range of other symptoms. The PACE trial was randomised to compare four non-pharmacological treatments for patients with CFS in secondary care clinics. The aims of this sub study were to describe the use of complementary and alternative medicine (CAM) in the trial sample and to test whether CAM use correlated with an improved outcome.

Method
CAM use was recorded at baseline and 52 weeks. Logistic and multiple regression models explored relationships between CAM use and both patient characteristics and trial outcomes.

Results
At baseline, 450/640 (70%) of participants used any sort of CAM; 199/640 (31%) participants were seeing a CAM practitioner and 410/640 (64%) were taking a CAM medication. At 52 weeks, those using any CAM fell to 379/589 (64%). Independent predictors of CAM use at baseline were female gender, local ME group membership, prior duration of CFS and treatment preference. At 52 weeks, the associated variables were being female, local ME group membership, and not being randomised to the preferred trial arm. There were no significant associations between any CAM use and fatigue at either baseline or 52 weeks. CAM use at baseline was associated with a mean (CI) difference of 4.10 (1.28, 6.91; p = 0.024) increased SF36 physical function score at 52 weeks, which did not reach the threshold for a clinically important difference.

Conclusion
CAM use is common in patients with CFS. It was not associated with any clinically important trial outcomes.
 
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Bob

Senior Member
Messages
16,455
Location
England (south coast)
This is from another thread. Posting it here in case anyone hasn't seen it, and because it's relevant...

Edzard Ernst wrote a good piece on A vs A+B trials

No negatives please, we are alternative!
Since several years, researchers in this field have adopted a study-design which is virtually sure to generate nothing but positive results. It is being employed widely by enthusiasts of placebo-therapies, and it is easy to understand why: it allows them to conduct seemingly rigorous trials which can impress decision-makers and invariably suggests even the most useless treatment to work wonders.
That's a helpful blog...

This is the research paper associated with it, which could be a handy reference to keep a note of...

Ernst E, Lee MS. A trial design that generates only "positive" results. J Postgrad Med. 2008;54:214-6.
http://www.jpgmonline.com/text.asp?2008/54/3/214/41806
http://www.ncbi.nlm.nih.gov/pubmed/18626172

Ernst et al. said:
We conclude that the 'A + B versus B' design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
Ernst et al. said:
In conclusion, our systematic review of RCTs of acupuncture for pain control with the 'A + B versus B' suggests that this trial methodology is likely to produce false positive results. Such studies may therefore not be adequate scientific tests of the effectiveness of therapeutic interventions.

It also mentions objective outcome measures...
Ernst et al. said:
Also, studies that employ objectively measurable endpoints might, in some cases, offer a protection against such false positive findings.

More discussion...
Ernst et al. said:
It would, of course, be an over-interpretation of our results to state categorically that RCTs with the 'A + B versus B' designs can, in principle, only generate positive results. We have shown this to be likely only for acupuncture as a treatment for pain. In other therapeutic areas, negative trials with that design may exist. Crucially, however, these RCTs do not fulfill the three additional criteria outlined in the introduction of this article. Interventions that are less prone to generating false positive findings when tested in a 'A + B versus B' study include those that not only do not improve but worsen the condition in question and treatments which do not generate sizable placebo-effects. Also, studies that employ objectively measurable endpoints might, in some cases, offer a protection against such false positive findings.
 

MEMum

Senior Member
Messages
440
What on earth is the point of this 'study'?

As the paper is behind a paywall we do not know the range of CAM (complementary and alternative healthcare).
When there are no known cures/treatments other than some for symptomatic relief, people are going to try 'alternatives'. Presumably this could include anything from taking a multivitamin to having a massage; from acupuncture to Zen Meditation.
More females than males have ME.!
Local groups often seem to run gentle stretch/yoga/meditation sessions as a way of helping people with life-altering conditions.
How can they possibly evaluate the benefits of CAM from this data. But then again it just reinforces the lack of effective treatment of any kind in the UK for people with ME.
How can build careers out of this unscientific garbage.
Yes I am having a rant !
 
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Bob

Senior Member
Messages
16,455
Location
England (south coast)
As the paper is behind a paywall we do not know the range of CAM (complementary and alternative healthcare).
When there are no known cures/treatments other than some for symptomatic relief, people are going to try 'alternatives'. Presumably this could include anything from taking a multivitamin to having a massage; from acupuncture to Zen Meditation.
I expect they wanted to demonstrate that receiving complementary therapies would inhibit "recovery" from CFS.
 

Dolphin

Senior Member
Messages
17,567
via @Tom Kindlon on Twitter.

Latest PACE publication...

Complementary and alternative healthcare use by participants in the PACE trial of treatments for chronic fatigue syndrome.
Lewith G, Stuart B, Chalder T, McDermott C, White PD.
Journal of Psychosomatic Research 2016;87:37-42.
10 June 2016.
http://www.jpsychores.com/article/S0022-3999(16)30327-0/abstract
http://www.sciencedirect.com/science/article/pii/S0022399916303270
I've started a thread on this here:
http://forums.phoenixrising.me/inde...n-the-pace-trial-of-treatments-for-cfs.45168/
 

Dolphin

Senior Member
Messages
17,567
Found
I'm working on something and the following would be useful for me:
Can anyone remember a paper that recommended the minimum clinically useful difference or the minimum clinically important difference for the Chalder Fatigue Scale should be 4. I have searched the 1st 80 pages (1600 posts) of this thread for "Chalder" and "clinical" but have not been able to find it. But I remember seeing it in a paper.
 
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mango

Senior Member
Messages
905
I'm working on something and the following would be useful for me:
Can anyone remember a paper that recommended the minimum clinically useful difference or the minimum clinically important difference for the Chalder Fatigue Scale should be 4. I have searched the 1st 80 pages (1600 posts) of this thread for "Chalder" and "clinical" but have not been able to find it. But I remember seeing it in a paper.

Could this be a clue, perhaps?

http://forums.phoenixrising.me/inde...ronic-fatigue-sabes-figura.22388/#post-341565
 

Dolphin

Senior Member
Messages
17,567
Not too exciting.

https://www.whatdotheyknow.com/request/pace_trial_raw_data#incoming-845826

PACE trial raw data
Robin Ellis made this Freedom of Information request to Queen Mary, University of London

The request was successful.


Robin Ellis 22 July 2016
Delivered


Dear Queen Mary, University of London,

To QMUL has spent her 250,000 pounds on fighting the release of the real data from the PACE trial, that has been used for a number of publications, my understanding that this is only the fees on the appeal for the release of data relating to the small almost illegible graph in appendix 2 of the follow up trial- the one that shows the GET/CBT to be ineffective.

i.e. the data that the PACE, authors are taking so much extreme pains to hide from imminent scientists who wish to re-analyse the data. If the scientists had nothing to hide, there is little doubt that for that sake of 100 pounds or less an external hard drive, with the data on it would have been provided to the scientists and others requesting this unidentified data.

This leads me to my question, what is the date on which the QMUL - data policy will allow the trial authors to burn/destroy this raw data.

Yours faithfully,

Robin






QM FOI Enquiries, Queen Mary, University of London 22 July 2016


We acknowledge receipt of your request and will respond as soon as we can.







QM FOI Enquiries, Queen Mary, University of London 29 July 2016


FOI 2016/F216

Dear Robin Ellis

Thank you for your email of 22nd July.

The PACE trial data will be retained until 2031, as explained on the
consent forms.


As an aside, the appeal at the First-Tier Tribunal (Information Rights)
concerned this request
[1]https://www.whatdotheyknow.com/request/s...

If you are dissatisfied with this response, you may ask QMUL to conduct a
review of this decision. To do this, please contact the College in
writing (including by fax, letter or email), describe the original
request, explain your grounds for dissatisfaction, and include an address
for correspondence. You have 40 working days from receipt of this
communication to submit a review request. When the review process has
been completed, if you are still dissatisfied, you may ask the Information
Commissioner to intervene. Please see [2]www.ico.org.uk for details.

Yours sincerely

Paul Smallcombe
Records & Information Compliance Manager


References

Visible links
1. https://www.whatdotheyknow.com/request/s...
2. http://www.ico.org.uk/
 
Messages
13,774
Hold on... in the response to Graham they talked about drawing a line under all FOI requests, even though the information Graham requested could be easily provided... yet this info was released?

I guess this info was already publicly available? I was going to say we should encourage people to post here before making any PACE FOIs so we could advise them on whether then information was already available... but that would definitely be seen as an evil conspiracy.

Also, I quite like that Smallcombe corrected Ellis on what exactly they spent £200,000 fighting against the release of.
 

Dolphin

Senior Member
Messages
17,567
Somebody asked me to post this for them:
“the bastards don’t want to get well”

There once was a professor called Peter, who claimed he could cure those who moan, they've chronic fatigue syndrome;

He had some help along the way, from Trudie, Michael, and Simon, who he later came to rely on…and he applied for a grant just to see, if he and his friends could fix people with CFS, or is it M.E.?

Now he believed the illness could go away, if patients who only say, that “it’s not pain or fatigue I feel”, but aberrant thought processes and bodily sensations, “that aren’t real”!

So he set to work, with five million or more and a trial just to see, if exercise and CBT could alter behaviour and belief, with an aim to stop depression and bring about relief, to the medically unexplained symptoms that caused so much grief;

Luckily for he, it was easy to see, that CBT changed patients’ minds…and cure was possible, if not probable, when thresholds altered and criteria faltered...;

But his findings weren’t welcomed by all; there were groups seeking to discredit, the merit of it all…being rapacious and vexatious; There were choppy seas, and the voyage was long, but with his friends by his side, he kept to his stride, and rode the waves of criticism that came along, until finally the end was in sight, that he’d proven he’s right, for anyone who glanced at it, reading the Lancet, would surely agree, that’s it’s all down to CBT;

However, when all seemed calm, when press conferences were over and the NHS accepted P.A.C.E., a well organised bunch of militant patients attacked everything and threw it all back in his face..;Some called it ‘unscientific’, some called it ‘horrific’, but he stuck to his guns and ignored all the puns…..

Yet the critics wouldn’t stop; some decreed that the trial didn’t even study M.E., while others shouted “it’s all flawed”, "a sham", "a scam", "not science"...."a fraud";

What was Peter to do or say? – he knows it works, "why wont they just just agree and obey", perhaps if not now, one day. So off he went with a S.M.I.L.E, he knew it would all be F.I.N.E. in a while, he wasn’t finished, only starting, it’s time to G.E.T.S.E.T he said, “it’s time for more CBT and GET”.