PACE Trial and PACE Trial Protocol

[Chrisb]

By way of a slight digression I just thought I should share with you the thought that I cannot see the name PACE without thinking how appropriate the name seems.

In England the acronym stands for The Police and Criminal Evidence Act 1986. The Act was introduced after a series of miscarriages of justice with verdicts sometimes being overturned on the second or third appearance before the highest appellate court. In one case the judges said they would have imposed the death sentence had it been available.

The cases followed a similar pattern. The police formed a view as to the likely suspects. They sought evidence to incriminate the suspects. They failed to investigate evidence which might exonerate the suspects and failed to disclose such information to defence solicitors. In some cases confessions were obtained under duress. The prosecution sought convictions rather than fulfilling their duty merely to present evidence to the court.

I cannot understand why this should come to mind. Perhaps therapy would help.

 

[daisybell]

It would be amusing to link the David Tuller article to the conference that Chalder is talkIng at. Surely at some point she has to be too embarrassed to keep presenting on the research....

 

[Dolphin]

(In case anyone missed it)
The journalist, David Tuller DrPH, has today posted a substantial piece on the PACE Trial:

TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
http://www.virology.ws/2015/10/21/trial-by-error-i/

There's an introduction and summary at the start if you don't want to take on the whole thing.

It's being discussed in this PR thread:
http://forums.phoenixrising.me/inde...he-pace-chronic-fatigue-syndrome-study.40664/

ME Network have also posted their own summary piece:
http://www.meaction.net/2015/10/21/david-tuller-tears-apart-pace-trial/

 

[Dolphin]

This comment from somebody who took part in the PACE Trial was posted in a public place so feel I can re-post it:

https://www.facebook.com/may12th.awareness/posts/10153037980487161?comment_id=10153038092542161&offset=0&total_comments=3&comment_tracking={"tn":"R"}

Ha Deb
It will take me a while to read this lol I took part in the pace trials and gave up after a few months. Done more damage than good. Utterly horrendous and now I've learned to live with and understand my illness I'm baffled that they even suggested it to people who suffer with this.

2 busses to get there, an hour or 2 in the hospital and 2 busses back, it took me a week to recover. Obviously created by people who have no understanding of ME.

 

[Tom Kindlon]

Page 127-8
Person in the PACE Trial who got worse with GET

#10: ME mild before course, became severe after course. Symptoms very much worse after. Course not appropriate to needs.
“As it was part of the PACE trial, a strict agenda was adhered to with no deviations. Also, the physio was not allowed to comment on any symptoms I may have had between sessions or as a result of treatment. The course was weekly for 4 weeks, fortnightly for 10 sessions and a last one 3 months later.”

The schedule does sound like the PACE Trial schedule and not one used much in clinical practice.

 

[Sasha]

Apologies for cross-posting but I'm aware that not everyone scours the Petitions subforum every morning.

Yesterday evening, a petition calling for The Lancet and Psychological Medicine to retract the misleading claims about recovery in the PACE trial was launched on #MEAction. The petition also calls for the per-protocol recovery analyses to be published and for the raw data for the analyses to be released.

#MEAction is Jen Brea's major, fantastically well-networked advocacy platform. There have already been over 2,700 signatures in just 18 hours.

Background pages that link from the petition explain the issues briefly and clearly for patients, supporters, journalists, scientists, anybody - and scientists in particular are going to be horrified at what they read. It's a fantastic advocacy tool.

This is it! PACE is falling. First Tuller, now the petition, and some other stuff coming hot on its heels.

Pile on, guys! Sign the petition, get it out there far and wide to your friends, relations, on Facebook, on Twitter - the internet is already on fire with it.

Let's get cracking!

http://my.meaction.net/petitions/pace-trial-needs-review-now

 

[Dolphin]

One person, Paul Everett, posted this on the ME Association Facebook page https://www.facebook.com/permalink....otal_comments=10&comment_tracking={"tn":"R2"}

He also posted it to another private ME group and when asked, said it could be re-posted:

I was on the PACE trial after having ME for 20+ years and I was desperate to finally be given some hope !! I was told CBT would be best for myself but was not available for a year - BUT if you help us with our PACE trial we will dangle a carrot of hope in front of you and you may be randomly selected to receive CBT… Happy Days … well not so happy days as my selection was nothing, just monitoring once in a while. I had to travel home on my own in floods of tears and massive confusion. So I was now on the PACE trial … so much paperwork to do …so many interviews where I poured my heart out and highlighted drugs that may help and what was good or bad for our condition ( after all we are the experts ) - it all seemed to fall on death ears as there was already a bias to it being a mental disorder as this was my Professors field. I invited my Professor to come and spend a day with me so he could really understand the struggle we live with in our environment - he declined my kind invitation and I realised from then on that no one was actually listening to me - I could go on but I think this was a common issue with patients on the trial. Anyhow the whole process set me back years, I did get CBT after the year as promised and my adviser was fantastic and really caring but had little experience with ME - I remember her saying it would be a good idea to take my computer out of my bedroom - I agreed and was looking forward to doing just that on my long train journey home - that plan of action must have been spoken about 10 years ago and guess what my computer is still in the flipping bedroom - help !!! Anyhow I send love and light out to all my fellow sufferers and survivors and there will be real help for us one day, keep positive, keep laughing at the crazy pain and comatose state we find ourselves in but please don't go near the gym xxxxx

 

[Dolphin]

From @Maxwhd on Twitter

PACE...the most ambitious trial for #mecfs that has ever been attempted...REC...administrators very stressed #pwme
twitdoc.com/4YDC

Powerpoint presentation by the PACE Trial manager.

 

[Dolphin]

(Auf Deutsch) German language blog on PACE Trial (Oct 31)

Melanie Schickedanz
Studie zum Erschöpfungssyndrom: Wenn die Wissenschaft versagt
Veröffentlicht: 31/10/2015 10:43 CET Aktualisiert: 31/10/2015 10:43 CET
http://www.huffingtonpost.de/melanie-schickedanz/wenn-wissenschaft-versagt_b_8406424.html

Thread: http://forums.phoenixrising.me/inde...man-language-blog-on-pace-trial-oct-31.40915/

 

[worldbackwards]

Interesting thing that popped up on Twitter today. Someone who's been reading the PACE manual:

Intriguing how they know these things already. You might think they'd known what was going to happen from the beginning. Or even had favourite trial arms. Surely not.

 

[Dolphin]

(In case anyone missed it)
The journalist, David Tuller DrPH, has today posted a substantial piece on the PACE Trial:

TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
http://www.virology.ws/2015/10/21/trial-by-error-i/

There's an introduction and summary at the start if you don't want to take on the whole thing.

It's being discussed in this PR thread:
http://forums.phoenixrising.me/inde...he-pace-chronic-fatigue-syndrome-study.40664/

ME Network have also posted their own summary piece:
http://www.meaction.net/2015/10/21/david-tuller-tears-apart-pace-trial/

The 4th segment came out today:


New part out today:
"Trial By Error, Continued: Did the PACE Study Really Adopt a ‘Strict Criterion’ for Recovery?"
http://www.virology.ws/2015/11/04/t...really-adopt-a-strict-criterion-for-recovery/

Main PR to discuss it: http://forums.phoenixrising.me/inde...he-pace-chronic-fatigue-syndrome-study.40664/

 

[Valentijn]

Intriguing how they know these things already. You might think they'd known what was going to happen from the beginning. Or even had favourite trial arms. Surely not.

Isn't it great when the outcome is proven before the trial even starts? Hell, why not just skip that whole "science" thing entirely!

 

[Daisymay]

Isn't it great when the outcome is proven before the trial even starts? Hell, why not just skip that whole "science" thing entirely!

Yes think of the money governments/funding bodies could save, when times are hard this seems the way to go.

 

[Dolphin]

Response from The Optimum Health Clinic
“Chronic Fatigue Syndrome sufferers can overcome symptoms of ME with Positive Thinking and Exercise”
http://www.theoptimumhealthclinic.c...ms-of-me-with-positive-thinking-and-exercise/

I'm not a big fan of the OHC, but comments on this reasonable enough.

 

[Tom Kindlon]

https://twitter.com/TomKindlon/status/662386946757558272

What about term #PACEgate (PACE-gate) to describe what has been uncovered on #PACEtrial by @davidtuller1 & others?
http://www.virology.ws/2015/10/21/trial-by-error-i/

 

[Large Donner]

Peter White said after questioning from Malcolm Hooper, "we did not study CFS/ME we used an operational definition of fatigue" for the Pace trial"

I was wondering if that exact statement has made it into Tullers article or further commentary and a summary of what that basically means.

It means they admit they did not study ME and made no attempt to include ME patients in the PACE trial and in fact they went out of their way to exclude a genuine neuroimmune cohort.

Has Coyne picked up on this to any great extent also?

 

[Dolphin]

Peter White said after questioning from Malcolm Hooper, "we did not study CFS/ME we used an operational definition of fatigue" for the Pace trial"

I was wondering if that exact statement has made it into Tullers article or further commentary and a summary of what that basically means.

It means they admit they did not study ME and made no attempt to include ME patients in the PACE trial and in fact they went out of their way to exclude a genuine neuroimmune cohort.

Has Coyne picked up on this to any great extent also?

Exact quote:

“The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME”:

I don't interpret it the way you and some other people are interpreting it. My guess is he has the Canadian criteria in mind. (I can't find the context at the moment).

In the Lancet 2011 paper they say in the abstract:

Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results

Participants were also assessed by international criteria for chronic fatigue syndrome, 12 requiring four or more accompanying symptoms, and the London criteria 13 for myalgic encephalomyelitis (version 2), requiring postexertional
fatigue, poor memory and concentration, symptoms that fluctuate, and no primary depressive or anxiety disorder (interpreted as an absence of any such disorder).

In Figure 2, they do subgroup analysis for M.E.

and other mentions of M.E.

 

[Large Donner]

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.

The cohort issue in PACE is really enormous as clearly demonstrated by many advocates at the time it simply pre screened out ME by use of weak criteria. They even used an unpublished criteria didnt they called the London criteria?

 

[Wildcat]

.
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.
.

 

[Large Donner]

.
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.
.

This is how I remember it being described by advocates like Malcolm Hooper and Angela Kennedy at the time, has Tuller gone into this in depth or James Coyne for that matter?