PACE Trial and PACE Trial Protocol

[Dolphin]

More signs the tide is turning: Vaughan Bell in The Lancet Psychiatry on routine data sharing
May 26, 2017James C Coyne chronic fatigue syndrome, clinical trials, Cochrane collaboration, data sharing, ME/CFS, PACE, Uncategorized Tags: The Lancet Psychiatry, Vaughn Bell

https://jcoynester.wordpress.com/20...he-lancet-psychiatry-on-routine-data-sharing/

 

[slysaint]

Ok....I am going to make it my mission to read this whole thread and hopefully not ask things that have already been answered.

But already have noted how often the phrase 'the tide is turning' has been used over the years; hopefully it really is this time.

 

[Valentijn]

But already have noted how often the phrase 'the tide is turning' has been used over the years; hopefully it really is this time.

Pretty sure it happens several times per day, actually

 

[Tom Kindlon]

https://twitter.com/i/web/status/869258890462081024

https://twitter.com/i/web/status/869259735282974721

 

[Dolphin]

Go ahead, former member of the Journal of Health Psychology editorial board, make my day
by James C Coyne
June 03, 2017
https://www.coyneoftherealm.com/blo...health-psychology-editorial-board-make-my-day

The authors fall into the trap of labelling the patients’ position as based on their cognitive models. That ignores the congruence of many articulate patients’ views with best evidence, as judged by the international community, not a small research group in the UK and their supporters.

I apparently concurred in my opinion with another reviewer that the manuscript should not be published. The member of the editorial board threw a tantrum and threatened to smear the journal in social media. She threatened to resign from the board. David Marks offered to have her pick a reviewer to reconsider her manuscript after making any revisions she wished. The member of the editorial board she chose was a close personal friend of Trudie Chalder.

I did not see the review, nor any revision that might have occurred, but the reviewer’s evaluation apparently concurred with mine.

 

[Dolphin]

A prominent Australian researcher comments on PACE.

Harm and the Pace Trial.

By Neil McGregor PhD.

https://www.dropbox.com/s/lrrz4gx5nnmo687/PACEStudyHarmAssessmentNM.pdf?dl=0

I haven't read this myself yet

 

[RogerBlack]

A prominent Australian researcher comments on PACE.


I haven't read this myself yet

Broad outline: PACE is being used to justify treatment of CFS patients it was never tested on (the severe group) At best it has a null outcome, but a reasonable case can be made that due to the problems in reporting changes, significant numbers of people could have been made a lot worse.

I thought I'd posted one of the criticisms that is missing in the paper - you can get worse a _lot_ in some cases before you're even considered to have a non-serious harm.
For example, going from able to work full time, to only being able to work part time Or being unable to do anything workwise, but being able to putter around in the garden for half an hour to not-quite bedbound.
These changes can persist forever, and still be 'non-serious'.

 

[Dolphin]

A prominent Australian researcher comments on PACE.

Harm and the Pace Trial.

By Neil McGregor PhD.

https://www.dropbox.com/s/lrrz4gx5nnmo687/PACEStudyHarmAssessmentNM.pdf?dl=0

I haven't read this myself yet

I wasn't that impressed with this unfortunately.
The start was okay. Nothing particularly new but the points were reasonable enough I thought:

Any conclusions that may be made can only be applied to the CFS patients with lower levels of syndrome severity. To apply the study findings to any seriously affected patients, those excluded, is not valid. However, these conclusions from this study appear to have been accepted universally and those with more severe disease are essentially treated as with those with lesser disease. No valid data exists for the seriously ill patients regarding these therapies.

From these definitions, the factors which the average MECFS patient knows is associated with symptom exacerbation, are considered “NON-SERIOUS”. These symptoms that patients see as “HARMFUL” to their daily lives yet the PACE study does not consider these as important.

---

These data indicate that multiple adverse events occurred in the vast majority of subjects within the study.

This is true. But what you would be particularly interested in would be if CBT and GET resulted in increased adverse events and this was not found. People with CFS tend to have a lot of symptoms and some fluctuations so you can't ascribe every adverse event to treatments.

---

Disease processes have variability and the symptom sets within the patients will fluctuate with time. The accepted proportions for this variation are 33.3% have an improvement, 33.3% do not change and 33.3% show an exacerbation of their condition.

I don't think one will necessarily get changes at 33%/33%/33%. One could equally get say 10%/80%/10% if the thresholds for change were not minimal.

Quite a bit of the latter part of the document assumes 33%/33%/33%

---

The telling analysis in the second paper is the percentage of subjects who deteriorated in their physical activity over the 52 months of the trial (p<.0007). The data for the percentage of subjects reported to have deteriorated over the trials are shown in Figure 7. Eleven percent of the graded exercise therapy group deteriorated over the 52 weeks of the study but even worse was the number who deteriorated with Adaptive pacing (25%).

CBT and GET actually did the best in this. So I'm not sure it says anything bad about CBT and GET.

I'm not sure however whether it really shows deterioration for APT. The APT did no worse than CBT on all the objective measures. I think it could simply be a reporting bias, that APT are now more cautious about activity.

 

[Dolphin]

The UNSW and PACE Trials for CFS patients: Influence of Natural Symptom Variation within the Syndrome.
By Neil McGregor PhD.

https://www.dropbox.com/s/u86kso4u3...Therapeutic Response to GET and CBT..pdf?dl=0

Unfortunately I was not that impressed with this in terms of the criticism of the PACE trial and its results.

The PACE and UNSW studies both failed to address the issue of exacerbation of the patient’s symptom severity as a motivation to join the trial. The only way to assess this appropriately is to do the study with a no treatment and/or placebo arm. In the light of these findings the conclusions given by the authors would appear to be invalid.

3. Studies of this type require a placebo and/or a no treatment group to allow assessment of the expected fall in symptoms due to settlement of symptoms following the exacerbation that triggered the patient’s attendance to the clinic for the trial.

5. A placebo and/or no treatment arm should be included in any study of this type to allow evaluation of the natural variation in symptom severity due to the presentation of patients for assessment when they in an exacerbation period.

The Specialist Medical Care-only group were effectively a no treatment group in the PACE trial. One could argue that the APT group was a placebo or a control group. The results obtained for CBT and GET on many subjective measures were better than these 2 groups so you can't necessarily put the changes down to natural fluctuations.

The UNSW study was different as there was no control group

 

[Esther12]

I didn't read either of those pieces closely, but on a skim through I was worried that some of the claims made were not safe. Thanks for going through them and then posting up your concerns. Important to try to keep PACE criticism as good as possible.

 

[Esther12]

Not really interesting enough for its own thread, particularly as we missed it, but I'd have liked a recording:

St Cross Special Ethics Seminar with Michael Sharpe
Thursday, June 1, 2017
Event type:
Academic
Date: Thursday 1 June, 17:30 – 19:00

Venue: The Lecture Theatre, St Cross College, St Giles, Oxford

Title: Science, Politics and the Internet: Challenges for Research into Contested Illness

Abstract: Some areas of scholarship are politicised. That is, organised groups of people have developed strong views for or against certain fields of research and certain findings arising from these.

Whilst we may generally regard openness, interconnectedness and the patient voice the internet offers as a good thing, it also present a major challenge for researchers in ‘contested fields’. The use of such co-ordinated pressure group action against science was prominently seen in the field of climate change research but is now emerging in other areas.

Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME for short) is one of these. The particular issue is the role of psychiatric or psychological approaches in the treatment of such patients. Protest against this form of enquiry has been present for decades. However, the increasing use of social media and blogs have co-ordinated and expanded the protest to an international one. It also provides the tool for the coordinated harassment of researchers by email, the issuing of repeated and co-ordinated freedom of information requests and the publication of comment on numerous blogs.

The implications of these internet-enabled protests for the future of science will be explored.

Speaker: Michael Sharpe is Professor of Psychological Medicine at the University of Oxford, consultant psychiatrist and Fellow of St Cross College. After initially studying Experimental Psychology in Oxford he trained in Medicine and then in Psychiatry in London, Cambridge and Oxford. His research has focussed on how best to integrate psychiatric and medical care for people with chronic medical illnesses, especially cancer and chronic fatigue syndrome. Professor Sharpe was the UK Royal College of Psychiatrists “Psychiatric Academic of the Year” in 2009 and ‘Psychiatrist of the year’ in 2014. He received the Don R Lipsett award for achievement in integrated care from the American Academy of Psychosomatic Medicine in 2015 and the Alison Creed award from the European Association of Psychosomatic Medicine (EAPM) in 2016.

Booking: INTERNAL. This event is open to members of Oxford University only. Email rachel.gaminiratne@philosophy.ox.ac.uk to reserve a place.

http://www.stx.ox.ac.uk/current-members/events/2773

 

[Valentijn]

Not really interesting enough for its own thread, particularly as we missed it, but I'd have liked a recording:

http://www.stx.ox.ac.uk/current-members/events/2773

This is nothing more than hate speech being used by supposed professionals to push an agenda. How the hell are they allowed to spew this backwards bile at educational institutions?

 

[Sean]

The sheer gall is breathtaking. You'd think after the widely publicised, unambiguous tribunal finding of no evidence of significant harassment at all, that they would be at least a little more circumspect and modest in their claims.

But no. Just keep telling the Big Lie at every opportunity.

 

[Hutan]

Michael Sharpe is Professor of Psychological Medicine at the University of Oxford, consultant psychiatrist and Fellow of St Cross College.

I was a member of St Cross College. Now I find it's an epicentre of BPS. Somehow it makes the affront more personal. I shall eventually write them a (polite) letter. Although as both a person from the colonies and an ME patient, my words won't count for much.

Whilst we may generally regard openness, interconnectedness and the patient voice the internet offers as a good thing, it also present a major challenge for researchers in ‘contested fields’. The use of such co-ordinated pressure group action against science was prominently seen in the field of climate change research but is now emerging in other areas.

The irony.

@harveythecat, are you still taking on Oxford?

 

[Ysabelle-S]

Bless, 85,000 doctors receiving a warning about the PACE trial in New York state must have come as a bitter blow to Sharpe. Can't recall if that was just after this event, but it was the May newsletter. I see the psychological projection continues with the weaponising of anti-climate science rhetoric. The poor little man looks at us and sees himself. He cannot be unaware of the science on ME, I mean the real science. All he can do is wail to those who will listen. I wonder if the little team of PACE charlatans and their accolytes have secretly ordered the DVDs from the Invest in ME conference, just to see what they're up against. It would be nice to think of them watching the TV in a darkened room as real scientists give presentations which are completely beyond their competence or ken. I'd happily send them a box of hankies to wipe their tears, though they could tear up their rank amateur trial instead and use that. Or maybe David Tuller could offer shreds of paper from his performance piece knows as Tearing Up The PACE Trial. These self-promoting fools might not be out the field yet, but their recent behaviour just flags up the mounting panic, paranoia and tin foil hat antics. So delicious to see their pompous pretence to be scientists.

P.S. Someone add that Sharpe/Oxford page to the internet wayback machine.

 

[Dolphin]

My peer review of a PACE investigators’ article that the authors refused to heed
by James C Coyne
June 12, 2017
https://www.coyneoftherealm.com/blo...tors-article-that-the-authors-refused-to-heed

 

[slysaint]

A few 'highlights'

"It’s extraordinary that 16 papers would come out of a single psychotherapy trial. The authors seem to be pointing to that as an accomplishment, but for others who are concerned with broader issues, it raises issues about duplicate publication and the integrity of the peer review under which those 16 papers were published."

"Their citing of Action for ME (2011) is inappropriate for a number of reasons. It’s an unrepresentative that was not subject to peer review. The claims that patients believe their treatments lead to improvement of contradicted by the extraordinary petitions signed by thousands."

"Advocates for the improvement of the trustworthiness of the psychological literature should be particularly offended by the distorted view offered in their point (3). They are dodging the very important issue of not only investigator allegiance, but investigator conflict of interest."

"...the authors abandoned their protocol and a substantial portion of the patients available for the follow-up were no longer receiving the treatment to which they were assigned."

"The authors substantially misrepresent the use of Freedom of Information Act requests and their response to them. They exaggerate the number of requests that were made by counting multiple times any request that involved multiple variables....They misrepresent the multiple times they’ve invoked the excuse that people who requested the data were vexatious."

"I find it odd that they retreat to a blog post by Simon Wessely as a defense of their many methodological problems."

"Their excuse that they do not release their data because the consent forms do not allow it was argued in proceedings that cost them over 250,000 pounds"

 

[Dolphin]

https://twitter.com/i/web/status/876828066034712576

 

[Cheshire]

Global expert on distant and faith healing chaired PACE Data Monitoring and Ethics Committee

Paul Dieppe, the initial Chair of Data Monitoring and Ethics Committee for the PACE trial is also renowned as a “leading global voice in the understanding and advancement of energy/ spiritual healing.”
Most of my medical colleagues think I’ve gone completely barmy – Paul Dieppe

https://jcoynester.wordpress.com/20...ed-pace-data-monitoring-and-ethics-committee/

 

[dangermouse]

Good grief!! It's gets worse. Thanks for posting @Cheshire

I'm speechless.